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Sample records for group randomized controlled

  1. Group Lidcombe Program Treatment for Early Stuttering: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Arnott, Simone; Onslow, Mark; O'Brian, Sue; Packman, Ann; Jones, Mark; Block, Susan

    2014-01-01

    Purpose: This study adds to the Lidcombe Program evidence base by comparing individual and group treatment of preschoolers who stutter. Method: A randomized controlled trial of 54 preschoolers was designed to establish whether group delivery outcomes were not inferior to the individual model. The group arm used a rolling group model, in which a…

  2. What to Do when Data Are Missing in Group Randomized Controlled Trials. NCEE 2009-0049

    ERIC Educational Resources Information Center

    Puma, Michael J.; Olsen, Robert B.; Bell, Stephen H.; Price, Cristofer

    2009-01-01

    This NCEE Technical Methods report examines how to address the problem of missing data in the analysis of data in Randomized Controlled Trials (RCTs) of educational interventions, with a particular focus on the common educational situation in which groups of students such as entire classrooms or schools are randomized. Missing outcome data are a…

  3. The quality of control groups in non-randomized studies published in Journal of Hand Surgery

    PubMed Central

    Johnson, Shepard P.; Malay, Sunitha; Chung, Kevin C.

    2016-01-01

    Purpose To evaluate control group selection in non-randomized studies published in the Journal of Hand Surgery American (JHS). Methods We reviewed all papers published in JHS in 2013 to identify studies that used non-randomized control groups. Data collected included type of study design and control group characteristics. We then appraised studies to determine if authors discussed confounding and selection bias and how they controlled for confounding. Results Thirty-seven non-randomized studies were published in JHS in 2013. The source of control was either the same institution as the study group, a different institution, a database, or not provided in the manuscript. Twenty-nine (78%) studies statistically compared key characteristics between control and study group. Confounding was controlled with matching, exclusion criteria, or regression analysis. Twenty-two (59%) papers explicitly discussed the threat of confounding and 18(49%) identified sources of selection bias. Conclusions In our review of non-randomized studies published in JHS, papers had well-defined controls that were similar to the study group, allowing for reasonable comparisons. However, we identified substantial confounding and bias that were not addressed as explicit limitations, which might lead the reader to overestimate the scientific validity of the data. Clinical relevance Incorporating a brief discussion of control group selection in scientific manuscripts should help readers interpret the study more appropriately. Authors, reviewers, and editors should strive to address this component of clinical importance. PMID:25447000

  4. Group Cognitive Behavioural Therapy and Group Recreational Activity for Adults with Autism Spectrum Disorders: A Preliminary Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Hesselmark, Eva; Plenty, Stephanie; Bejerot, Susanne

    2014-01-01

    Although adults with autism spectrum disorder are an increasingly identified patient population, few treatment options are available. This "preliminary" randomized controlled open trial with a parallel design developed two group interventions for adults with autism spectrum disorders and intelligence within the normal range: cognitive…

  5. A single blind randomized control trial on support groups for Chinese persons with mild dementia

    PubMed Central

    Young, Daniel KW; Kwok, Timothy CY; Ng, Petrus YN

    2014-01-01

    Purpose Persons with mild dementia experience multiple losses and manifest depressive symptoms. This research study aimed to evaluate the effectiveness of a support group led by a social worker for Chinese persons with mild dementia. Research methods Participants were randomly assigned to either a ten-session support group or a control group. Standardized assessment tools were used for data collection at pretreatment and post-treatment periods by a research assistant who was kept blind to the group assignment of the participants. Upon completion of the study, 20 treatment group participants and 16 control group participants completed all assessments. Results At baseline, the treatment and control groups did not show any significant difference on all demographic variables, as well as on all baseline measures; over one-half (59%) of all the participants reported having depression, as assessed by a Chinese Geriatric Depression Scale score ≥8. After completing the support group, the depressive mood of the treatment group participants reduced from 8.83 (standard deviation =2.48) to 7.35 (standard deviation =2.18), which was significant (Wilcoxon signed-rank test; P=0.017, P<0.05), while the control group’s participants did not show any significant change. Conclusion This present study supports the efficacy and effectiveness of the support group for persons with mild dementia in Chinese society. In particular, this present study shows that a support group can reduce depressive symptoms for participants. PMID:25587218

  6. An effective group psychoeducational intervention for improving compliance with vaginal dilation: A randomized controlled trial

    SciTech Connect

    Jeffries, Sherryl A.; Robinson, John W. . E-mail: johnrobi@cancerboard.ab.ca; Craighead, Peter S.; Keats, Melanie R.

    2006-06-01

    Purpose: Although vaginal dilation is often recommended to minimize or prevent vaginal scarring after pelvic radiotherapy, compliance with this recommendation has historically been very low. Therefore, effective intervention strategies are needed to enhance compliance with vaginal dilation after radiotherapy for gynecologic cancer. Methods and Materials: This study was a randomized controlled clinical trial of a psychoeducational intervention specifically designed to increase compliance with vaginal dilation. The information-motivation-behavioral skills model of enhancing compliance with behavioral change was the basis for the intervention design. Forty-two sexually active women, 21 to 65 years of age, diagnosed with Stages Ic-III cervical or endometrial cancer, who received pelvic radiotherapy, were randomized to either the experimental psychoeducational group or the information-only control group. Assessment via questionnaire occurred before treatment and at 6-week, 6-month, 12-month, 18-month, and 24-month follow-up. Assessment via interview also occurred at 6-month, 12-month, 18-month, and 24-month follow-up. Results: The psychoeducational intervention was successful in increasing compliance with vaginal dilation. Conclusions: This study is the first randomized controlled study to demonstrate the effectiveness of an intervention in increasing compliance with the use of vaginal dilators.

  7. A randomized controlled trial of group Stepping Stones Triple P: a mixed-disability trial.

    PubMed

    Roux, Gemma; Sofronoff, Kate; Sanders, Matthew

    2013-09-01

    Stepping Stones Triple P (SSTP) is a parenting program designed for families of a child with a disability. The current study involved a randomized controlled trial of Group Stepping Stones Triple P (GSSTP) for a mixed-disability group. Participants were 52 families of children diagnosed with an Autism Spectrum Disorder, Down syndrome, Cerebral Palsy, or an intellectual disability. The results demonstrated significant improvements in parent-reported child behavior, parenting styles, parental satisfaction, and conflict about parenting. Results among participants were similar despite children's differing impairments. The intervention effect was maintained at 6-month follow-up. The results indicate that GSSTP is a promising intervention for a mixed-disability group. Limitations of the study, along with areas for future research, are also discussed. PMID:24033239

  8. Inappropriate statistical method in a parallel-group randomized controlled trial results in unsubstantiated conclusions.

    PubMed

    Dimova, Rositsa B; Allison, David B

    2016-01-01

    The conclusions of Cassani et al. in the January 2015 issue of Nutrition Journal (doi: 10.1186/1475-2891-14-5 ) cannot be substantiated by the analysis reported nor by the data themselves. The authors ascribed the observed decrease in inflammatory markers to the components of flaxseed and based their conclusions on within-group comparisons made between the final and the baseline measurements separately in each arm of the randomized controlled trial. However, this is an improper approach and the conclusions of the paper are invalid. A correct analysis of the data shows no such effects. PMID:27265269

  9. A Randomized Controlled Trial of Ecological Momentary Intervention Plus Brief Group Therapy for Generalized Anxiety Disorder

    PubMed Central

    Newman, Michelle G.; Przeworski, Amy; Consoli, Andrés J.; Taylor, C. Barr

    2015-01-01

    Momentary intervention has been proposed as a cost-effective, generalizable, and ecologically valid method to increase the efficiency of face-to-face cognitive– behavioral therapy (CBT). The purpose of the current pilot study was to evaluate the efficacy of a six-session palmtop computer-assisted Group CBT for generalized anxiety disorder (GAD) (CAGT6) in comparison with a six-session Group CBT for GAD without the computer (CBGT6) and typical (12 session) Group CBT for GAD (CBGT12) in a randomized controlled trial. Thirty-four individuals with a primary diagnosis of GAD were randomized to one of the three conditions and completed measures of GAD and anxiety before therapy, after therapy, and at 6-, and 12-month follow-ups. Results indicated that CAGT6 was superior to CBGT6 at posttreatment, but not significantly different from CBGT12. At 6- and 12-month follow-ups, CAGT6 was neither significantly different from CBGT6, nor from CBGT12. Percentages of individuals achieving reliable change on two of the three GAD measures favored CAGT6 over CBGT6 at posttreatment, suggesting promise for the added value of the mobile technology. PMID:24059730

  10. Group behavioral activation for patients with severe obesity and binge eating disorder: a randomized controlled trial.

    PubMed

    Alfonsson, Sven; Parling, Thomas; Ghaderi, Ata

    2015-03-01

    The aim of the present study was to assess whether behavioral activation (BA) is an efficacious treatment for decreasing eating disorder symptoms in patients with obesity and binge eating disorder (BED). Ninety-six patients with severe obesity and BED were randomized to either 10 sessions of group BA or wait-list control. The study was conducted at an obesity clinic in a regular hospital setting. The treatment improved some aspects of disordered eating and had a positive effect on depressive symptoms but there was no significant difference between the groups regarding binge eating and most other symptoms. Improved mood but lack of effect on binge eating suggests that dysfunctional eating (including BED) is maintained by other mechanisms than low activation and negative mood. However, future studies need to investigate whether effects of BA on binge eating might emerge later than at post-assessment, as in interpersonal psychotherapy for bulimia nervosa. PMID:25268019

  11. Individual vs. Group-Based Incentives for Weight Loss: A Randomized, Controlled Trial

    PubMed Central

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

    2014-01-01

    Background There are limited data on the effectiveness of employer-sponsored financial incentives for employee weight loss. Objective To test the effectiveness of two financial incentive designs for promoting weight loss among obese employees. Design Randomized controlled trial. Allocation sequence was generated dynamically at the time of request of treatment assignment. Participants were unblinded to assignment; investigators were blinded to assignment until collection of primary outcome data. Setting Children’s Hospital of Philadelphia Participants 105 employees with a body mass index between 30 and 40 kg/m2 Interventions 24 weeks of monthly weigh-ins (control)(n=35); individual incentive, designed as $100 per person per month for meeting or exceeding target weight loss (individual arm)(n=35); group incentive, designed as $500 per month split between any participant within groups of 5 who met or exceeded their target weight loss (group arm)(n=35). Measurements Weight loss after 24 weeks (primary outcome); weight loss after 36 weeks, changes in behavioral mediators of weight loss (secondary outcomes). Results Group incentive participants lost more weight than individual arm participants (between-group difference in weight loss favoring group = mean 9.7 pounds, 95% CI 4.4 to 14.9; P < 0.001). Twelve weeks after incentives ended and adjusting for 3-group comparisons, group arm participants maintained greater weight loss than control arm participants (between-group difference in weight loss = mean 6.5 pounds, 95% CI 1.2 to 11.7; P = 0.016) but not more than individual arm participants (difference = 5.9 pounds, 95% CI, 0.8 to 11.0; P = 0.024). Limitations Single employer, short follow-up Conclusions A group-based financial incentive was more effective than an individual incentive and monthly weigh-ins at promoting weight loss among obese employees at 24 weeks. Primary Funding Source National Institute on Aging Trial Registration ClinicalTrials.gov Identifier: NCT

  12. Mindfulness training improves attentional task performance in incarcerated youth: a group randomized controlled intervention trial

    PubMed Central

    Leonard, Noelle R.; Jha, Amishi P.; Casarjian, Bethany; Goolsarran, Merissa; Garcia, Cristina; Cleland, Charles M.; Gwadz, Marya V.; Massey, Zohar

    2013-01-01

    We investigated the impact of cognitive behavioral therapy and mindfulness training (CBT/MT) on attentional task performance in incarcerated adolescents. Attention is a cognitive system necessary for managing cognitive demands and regulating emotions. Yet persistent and intensive demands, such as those experienced during high-stress intervals like incarceration and the events leading to incarceration, may deplete attention resulting in cognitive failures, emotional disturbances, and impulsive behavior. We hypothesized that CBT/MT may mitigate these deleterious effects of high stress and protect against degradation in attention over the high-stress interval of incarceration. Using a quasi-experimental, group randomized controlled trial design, we randomly assigned dormitories of incarcerated youth, ages 16–18, to a CBT/MT intervention (youth n = 147) or an active control intervention (youth n = 117). Both arms received approximately 750 min of intervention in a small-group setting over a 3–5 week period. Youth in the CBT/MT arm also logged the amount of out-of-session time spent practicing MT exercises. The Attention Network Test was used to index attentional task performance at baseline and 4 months post-baseline. Overall, task performance degraded over time in all participants. The magnitude of performance degradation was significantly less in the CBT/MT vs. control arm. Further, within the CBT/MT arm, performance degraded over time in those with no outside-of-class practice time, but remained stable over time in those who practiced mindfulness exercises outside of the session meetings. Thus, these findings suggest that sufficient CBT/MT practice may protect against functional attentional impairments associated with high-stress intervals. PMID:24265621

  13. Group cognitive behavioural therapy and group recreational activity for adults with autism spectrum disorders: A preliminary randomized controlled trial

    PubMed Central

    Plenty, Stephanie; Bejerot, Susanne

    2014-01-01

    Although adults with autism spectrum disorder are an increasingly identified patient population, few treatment options are available. This preliminary randomized controlled open trial with a parallel design developed two group interventions for adults with autism spectrum disorders and intelligence within the normal range: cognitive behavioural therapy and recreational activity. Both interventions comprised 36 weekly 3-h sessions led by two therapists in groups of 6–8 patients. A total of 68 psychiatric patients with autism spectrum disorders participated in the study. Outcome measures were Quality of Life Inventory, Sense of Coherence Scale, Rosenberg Self-Esteem Scale and an exploratory analysis on measures of psychiatric health. Participants in both treatment conditions reported an increased quality of life at post-treatment (d = 0.39, p < 0.001), with no difference between interventions. No amelioration of psychiatric symptoms was observed. The dropout rate was lower with cognitive behavioural therapy than with recreational activity, and participants in cognitive behavioural therapy rated themselves as more generally improved, as well as more improved regarding expression of needs and understanding of difficulties. Both interventions appear to be promising treatment options for adults with autism spectrum disorder. The interventions’ similar efficacy may be due to the common elements, structure and group setting. Cognitive behavioural therapy may be additionally beneficial in terms of increasing specific skills and minimizing dropout. PMID:24089423

  14. After-School Multifamily Groups: A Randomized Controlled Trial Involving Low-Income, Urban, Latino Children

    ERIC Educational Resources Information Center

    McDonald, Lynn; Moberg, D. Paul; Brown, Roger; Rodriguez-Espiricueta, Ismael; Flores, Nydia I.; Burke, Melissa P.; Coover, Gail

    2006-01-01

    This randomized controlled trial evaluated a culturally representative parent engagement strategy with Latino parents of elementary school children. Ten urban schools serving low-income children from mixed cultural backgrounds participated in a large study. Classrooms were randomly assigned either either to an after-school, multifamily support…

  15. A randomized controlled trial of a tailored group smoking cessation intervention for HIV-infected smokers

    PubMed Central

    Moadel, Alyson B.; Bernstein, Steven L.; Mermelstein, Robin J.; Arnsten, Julia H.; Dolce, Eileen H.; Shuter, Jonathan

    2013-01-01

    Background More than half of persons living with HIV (PLWH) in the US smoke cigarettes, and tobacco use is responsible for considerable morbidity and mortality in this group. Little is known about the efficacy of tobacco treatment strategies in PLWH. Design Randomized controlled trial comparing Positively Smoke Free (PSF), an intensive group therapy intervention targeting HIV-infected smokers, to standard care. Methods A cohort of 145 PLWH smokers, recruited from an HIV-care center in the Bronx, New York, were randomized 1:1 into the PSF program or standard care. All were offered a 3-month supply of nicotine replacement therapy. PSF is an eight session program tailored to address the needs and concerns of HIV-infected smokers. Sessions were co-facilitated by a graduate student and an HIV-infected peer. The primary outcome was biochemically-confirmed, seven-day point-prevalence abstinence at three months. Results In the intention to treat analysis, PSF condition subjects had nearly double the quit rate of controls (19.2% vs 9.7%, P=0.11). In the complete case, as-treated analysis, assignment to PSF was associated with increased odds of quitting (ORadj 3.55, 95% CI: 1.04– 12.0). Latino ethnicity and lower loneliness score were predictive of abstinence. Subjects in the PSF condition exhibited significant decreases in daily cigarette consumption and significant increases in self-efficacy and in motivation to quit. Attendance of ≥7 sessions was associated with higher quit rates. Conclusions These findings suggest a positive effect of PSF on cessation rates in PLWH smokers. Loneliness and self-efficacy are influential factors in the smoking behaviors of PLWH. PMID:22732470

  16. Reducing Aggressive Behavior in Boys with a Social Cognitive Group Treatment: Results of a Randomized, Controlled Trial.

    ERIC Educational Resources Information Center

    Van Manen, Teun G.; Prins, Pier J.M.; Emmelkamp, Paul M.G.

    2004-01-01

    Objective: To evaluate the effectiveness of a social cognitive intervention program for Dutch aggressive boys and to compare it with a social skills training and a waitlist control group. Method: A randomized, controlled treatment outcome study with 97 aggressive boys (aged 9-13 years) was presented. An 11 session group treatment, a social…

  17. Incorporating family therapy into asthma group intervention: a randomized waitlist-controlled trial.

    PubMed

    Ng, S M; Li, Albert M; Lou, Vivian W Q; Tso, Ivy F; Wan, Pauline Y P; Chan, Dorothy F Y

    2008-03-01

    Asthma psychoeducational programs have been found to be effective in terms of symptom-related outcome. They are mostly illness-focused, and pay minimal attention to systemic/familial factors. This study evaluated a novel asthma psychoeducation program that adopted a parallel group design and incorporated family therapy. A randomized waitlist-controlled crossover clinical trial design was adopted. Children with stable asthma and their parents were recruited from a pediatric chest clinic. Outcome measures included, for the patients: exhaled nitric oxide (eNO), spirometry, and adjustment to asthma; and for the parents: perceived efficacy in asthma management, Hospital Anxiety and Depression Scale anxiety subscale, Body Mind Spirit Well-being Inventory emotion subscale, and Short Form 12 health-related quality of life scale. Forty-six patients participated in the study. Attrition rates were 13.0% and 26.0% for the active and control groups, respectively. Repeated-measures ANOVA revealed a significant decrease in airway inflammation, as indicated by eNO levels, and an increase in patient's adjustment to asthma and parents' perceived efficacy in asthma management. Serial trend analysis revealed that most psychosocial measures continued to progress steadily after intervention. Significant improvements in both symptom-related measures and mental health and relationship measures were observed. The findings supported the value of incorporating family therapy into asthma psychoeducation programs. PMID:18411833

  18. Improving Parental Stress Levels Among Mothers Living with HIV: A Randomized Control Group Intervention Study

    PubMed Central

    Johnson, Erica R.; Davies, Susan L.; Aban, Inmaculada; Mugavero, Michael J.; Shrestha, Sadeep

    2015-01-01

    Abstract Limited knowledge exists regarding parenting efficacy interventions for mothers living with HIV (MLH). This study evaluated the impact of a supportive group intervention on lowering parenting stress among MLH. Eighty MLH were randomized to a parenting (N=34) or health focused (control) (N=46) group intervention. Pre- and post-intervention stress levels were assessed using the Parental Stress Index-Short Form (PSI/SF). Differences in PSI/SF scores were examined using ANOVA, and predictors of PSI/SF scores were evaluated using multivariable linear regression. Findings indicate that both groups experienced significant decreases in parenting stress from baseline to post-intervention (p=0.0001), with no significant differences between interventions. At baseline, 41% of participants were identified as highly stressed and 30% as clinically stressed, with PSI/SF scores above the 85th and 90th percentile, respectively. Amongst the highly stressed subpopulation, significant improvements in PSI/SF scores for Parental Distress PSI/SF (p=0.039), Difficult Child PSI/SF (p=0.048), and total PSI/SF (p=0.036) were seen, with greater improvements in the parenting intervention. Among the clinically stressed subpopulation, significant improvements in total post-intervention PSI/SF scores were seen (p=0.049), with greater improvements in the parenting intervention. Results indicate that screening for high levels of stress should be considered in clinical practice to effectively implement stress-reducing interventions among MLH. PMID:25734870

  19. Weight change among people randomized to minimal intervention control groups in weight loss trials

    PubMed Central

    Johns, David J.; Hartmann‐Boyce, Jamie; Jebb, Susan A.; Aveyard, Paul

    2016-01-01

    Objective Evidence on the effectiveness of behavioral weight management programs often comes from uncontrolled program evaluations. These frequently make the assumption that, without intervention, people will gain weight. The aim of this study was to use data from minimal intervention control groups in randomized controlled trials to examine the evidence for this assumption and the effect of frequency of weighing on weight change. Methods Data were extracted from minimal intervention control arms in a systematic review of multicomponent behavioral weight management programs. Two reviewers classified control arms into three categories based on intensity of minimal intervention and calculated 12‐month mean weight change using baseline observation carried forward. Meta‐regression was conducted in STATA v12. Results Thirty studies met the inclusion criteria, twenty‐nine of which had usable data, representing 5,963 participants allocated to control arms. Control arms were categorized according to intensity, as offering leaflets only, a single session of advice, or more than one session of advice from someone without specialist skills in supporting weight loss. Mean weight change at 12 months across all categories was −0.8 kg (95% CI −1.1 to −0.4). In an unadjusted model, increasing intensity by moving up a category was associated with an additional weight loss of −0.53 kg (95% CI −0.96 to −0.09). Also in an unadjusted model, each additional weigh‐in was associated with a weight change of −0.42 kg (95% CI −0.81 to −0.03). However, when both variables were placed in the same model, neither intervention category nor number of weigh‐ins was associated with weight change. Conclusions Uncontrolled evaluations of weight loss programs should assume that, in the absence of intervention, their population would weigh up to a kilogram on average less than baseline at the end of the first year of follow‐up. PMID:27028279

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

    PubMed Central

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

    2015-01-01

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

  1. Does Family Group Decision Making Affect Child Welfare Outcomes? Findings from a Randomized Control Study

    ERIC Educational Resources Information Center

    Berzin, Stephanie Cosner; Cohen, Ed; Thomas, Karen; Dawson, William C.

    2008-01-01

    This article describes the evaluation of two family group decision-making programs administered under the California Title IV-E Waiver Demonstration Project. This is the only evaluation using random assignment to examine FGDM. Overall, results did not indicate more positive outcomes for children receiving the intervention, but did indicate that…

  2. Restricted random labeling: testing for between-group interaction after controlling for joint population and within-group spatial structure

    NASA Astrophysics Data System (ADS)

    Kronenfeld, Barry J.; Leslie, Timothy F.

    2015-01-01

    Statistical measures of spatial interaction between multiple types of entities are commonly assessed against a null model of either toroidal shift (TS), which controls for spatial structure of individual subpopulations, or random labeling (RL), which controls for spatial structure of the joint population. Neither null model controls for both types of spatial structure simultaneously, although this may sometimes be desirable when more than two subpopulations are present. To address this, we propose a flexible framework for specifying null models that we refer to as restricted random labeling (rRL). Under rRL, a specified subset of individuals is restricted and other individuals are randomly relabeled. Within this framework, two specific null models are proposed for pairwise analysis within populations consisting of three or more subpopulations, to simultaneously control for spatial structure in the joint population and one or the other of the two subpopulations being analyzed. Formulas are presented for calculating expected nearest neighbor counts and co-location quotients within the proposed framework. Differences between TS, RL and rRL are illustrated by application to six types of generating processes in a simulation study, and to empirical datasets of tree species in a forest and crime locations in an urban setting. These examples show that rRL null models are typically stricter than either TS or RL, which often detect "interactions" that are an expected consequence either of the joint population pattern or of individual subpopulation patterns.

  3. Group cognitive remediation therapy for chronic schizophrenia: A randomized controlled trial.

    PubMed

    Tan, Shuping; Zou, Yizhuang; Wykes, Til; Reeder, Clare; Zhu, Xiaolin; Yang, Fude; Zhao, Yanli; Tan, Yunlong; Fan, Fengmei; Zhou, Dongfeng

    2016-07-28

    Individual-level cognitive remediation therapy (CRT) has been shown to be effective for cognitive improvement and social function amelioration. Here, we aimed to test the efficacy of group-based CRT in Chinese subjects with schizophrenia. One-hundred and four inpatients were randomly assigned to either 40 sessions of small-group CRT therapy or therapeutic contact-matched Musical and Dancing Therapy (MDT). Cognitive and social functioning, as well as clinical symptoms, were evaluated over the course of treatment. Specifically, cognitive function was evaluated using a battery of cognitive measurements, clinical symptoms were evaluated using the Positive and Negative Syndrome Scale, and social function was evaluated using the Nurse's Observation Scale for Inpatient Evaluation-30. All patients were evaluated pre- and post-treatment. Forty-four individuals in the CRT group and 46 in the MDT group completed all of the planned treatments and analyses. Cognitive functions, especially cognitive flexibility and memory, showed significant improvement in the CRT group over the course of the study. The MDT group also showed improvement in several cognitive flexibility assessments, but the degree of improvement was significantly greater in the CRT group. Several social-function factors exhibited a significant improvement in the CRT group, but not in the MDT group. Cognitive function improvement correlated positively with social function without predicting social function change. We conclude that group-based CRT is an effective and promising therapy. PMID:26314508

  4. Does family group decision making affect child welfare outcomes? Findings from a randomized control study.

    PubMed

    Berzin, Stephanie Cosner; Cohen, Ed; Thomas, Karen; Dawson, William C

    2008-01-01

    This article describes the evaluation of two family group decision-making programs (FGDM; Fresno n = 60; Riverside n = 50) administered under the California Title IV-E Waiver Demonstration Project. This is the only evaluation using random assignment to examine FGDM. Overall, results did not indicate more positive outcomes for children receiving the intervention, but did indicate that children were not worse than those receiving traditional services; outcomes examined were related to child safety, placement stability, and permanence. PMID:19391466

  5. Improving Quality of Life in Men With Prostate Cancer: A Randomized Controlled Trial of Group Education Interventions

    PubMed Central

    Lepore, Stephen J.; Helgeson, Vicki S.; Eton, David T.; Schulz, Richard

    2008-01-01

    Men who were recently treated for prostate cancer (N = 250) were randomly assigned to a control group, a group education intervention (GE), or a group education-plus-discussion intervention (GED). Both GE and GED increased prostate cancer knowledge. In the year postintervention, men in the GED condition were less bothered by sexual problems than men in the control condition, and they were more likely to remain steadily employed (93.0%) than men in the GE (75.6%) or control (72.5%) conditions. Among noncollege graduates, GED and GE resulted in better physical functioning than the control condition, and GED resulted in more positive health behaviors than the control or GE condition. Among college graduates, controls were comparable with the GE and GED groups in physical functioning and positive health behaviors. PMID:14570527

  6. Effectiveness of interactive discussion group in suicide risk assessment among general nurses in Taiwan: a randomized controlled trial.

    PubMed

    Wu, Chia-Yi; Lin, Yi-Yin; Yeh, Mei Chang; Huang, Lian-Hua; Chen, Shaw-Ji; Liao, Shih-Cheng; Lee, Ming-Been

    2014-11-01

    The evidence of suicide prevention training for nurses is scarce. Strategies to enhance general nurses' ability in suicide risk assessment are critical to develop effective training programs in general medical settings. This study was aimed to examine the effectiveness of an interactive discussion group in a suicide prevention training program for general nurses. In this randomized study with two groups of pre-post study design, the sample was recruited from the Medical, Surgical, and Emergency/Intensive Care Sectors of a 2000-bed general hospital via stratified randomization. Among the 111 nurses, 57 participants randomly assigned to the control group received a two-hour baseline suicide gatekeeper lecture, and 54 participants assigning to the experimental group received an additional five-hour group discussion about suicide risk assessment skills. Using a case vignette, the nurses discussed and assessed suicide risk factors specified in a 10-item Chinese SAD PERSONS Scale during a group discussion intervention. The findings revealed that the nurses achieved significant and consistent improvements of risk identification and assessment after the intervention without influencing their mental health status for assessing suicide risks. The result suggested an effective approach of interactive group discussion for facilitating critical thinking and learning suicide risk assessment skills among general nurses. PMID:24768204

  7. Effectiveness of a Dissonance-Based Eating Disorder Prevention Program for Ethnic Groups in Two Randomized Controlled Trials

    PubMed Central

    Stice, Eric; Marti, C. Nathan; Cheng, Zhen Hadassah

    2014-01-01

    Objective As young women from certain ethnic minority groups have reported less pursuit of the thin ideal and body dissatisfaction than European American young women we tested whether a dissonance-based prevention program designed to reduce thin-ideal internalization among women with body dissatisfaction is less effective for the former relative to the later groups. We also tested whether intervention effects are larger when participants from minority groups worked with a facilitator matched versus not matched on ethnicity. Method In Study 1, 426 female undergraduates (M age = 21.6, SD = 5.6) were randomized to clinician-led Body Project groups or an educational control group. In Study 2, 189 female undergraduates were randomized to peer-led Body Project groups or a waitlist control condition. Results Although there was some variation in risk factor scores across ethnic groups, ethnic minority participants did not demonstrate consistently higher or lower risk relative to European American participants. Intervention effects did not significantly differ for participants from minority groups versus European American participants in either trial. There was no evidence that effects were significantly larger when minority participants and facilitators were matched on ethnicity. Conclusions Results suggest that the Body Project is similarly effective for African American, Asian American, European American, and Hispanic female college students, and when participants and facilitators are matched or not on minority ethnicity status, implying that this prevention program can be broadly disseminated in this population. PMID:24655465

  8. Meaning-centered group psychotherapy for patients with advanced cancer: a pilot randomized controlled trial

    PubMed Central

    Breitbart, William; Rosenfeld, Barry; Gibson, Christopher; Pessin, Hayley; Poppito, Shannon; Nelson, Christian; Tomarken, Alexis; Timm, Anne Kosinski; Berg, Amy; Jacobson, Colleen; Sorger, Brooke; Abbey, Jennifer; Olden, Megan

    2013-01-01

    Objectives An increasingly important concern for clinicians who care for patients at the end of life is their spiritual well-being and sense of meaning and purpose in life. In response to the need for short-term interventions to address spiritual well-being, we developed Meaning Centered Group Psychotherapy (MCGP) to help patients with advanced cancer sustain or enhance a sense of meaning, peace and purpose in their lives, even as they approach the end of life. Methods Patients with advanced (stage III or IV) solid tumor cancers (N = 90) were randomly assigned to either MCGP or a supportive group psychotherapy (SGP). Patients were assessed before and after completing the 8-week intervention, and again 2 months after completion. Outcome assessment included measures of spiritual well-being, meaning, hopelessness, desire for death, optimism/pessimism, anxiety, depression and overall quality of life. Results MCGP resulted in significantly greater improvements in spiritual well-being and a sense of meaning. Treatment gains were even more substantial (based on effect size estimates) at the second follow-up assessment. Improvements in anxiety and desire for death were also significant (and increased over time). There was no significant improvement on any of these variables for patients participating in SGP. Conclusions MCGP appears to be a potentially beneficial intervention for patients’ emotional and spiritual suffering at the end of life. Further research, with larger samples, is clearly needed to better understand the potential benefits of this novel intervention. PMID:19274623

  9. Motivational interviewing for smoking cessation in college students: A group randomized controlled trial

    PubMed Central

    Harris, Kari Jo; Catley, Delwyn; Good, Glenn E.; Cronk, Nikole J.; Harrar, Solomon; Williams, Karen B.

    2010-01-01

    Objective To examine the efficacy of four individually-delivered Motivational Interviewing counseling sessions for smoking cessation versus a matched intensity comparison condition. Method From 2006–2009, students attending college in the Midwest smoking at least 1 of 30 days were recruited regardless of their interest in quitting. 30 fraternities and sororities were randomized, resulting in 452 participants. Results No significant differences were found for 30-day cessation between treatment and comparison at end of treatment (31.4% vs 28%, OR=1.20, 95% CI .72,1.99) or at follow-up (20.4% vs 24.6%, OR=.78, 95% CI .50,1.22). Predictors of cessation at follow-up, regardless of condition, included more sessions attended (OR 1.2, 95% CI 1.1,1.8) and more cigarettes smoked in 30 days at baseline (OR 4.7, 95% CI 2.5,8.9). The odds of making at least one quit attempt were significantly greater for those in the smoking group at end of treatment (OR 1.75, 95% CI 1.11,2.74) and follow-up (OR 1.66, 95% CI 1.11,2.47). Modeling showed reduction in days smoked for both groups. At end of treatment, more frequent smokers in the treatment condition had greater reductions in days smoked. Conclusion Motivational Interviewing for smoking cessation is effective for increasing cessation attempts and reducing days smoked in the short run. PMID:20828584

  10. Control of Blood Pressure and Risk Attenuation: Post Trial Follow-Up of Randomized Groups

    PubMed Central

    Jafar, Tazeen H.; Jehan, Imtiaz; Liang, Feng; Barbier, Sylvaine; Islam, Muhammad; Bux, Rasool; Khan, Aamir Hameed; Nadkarni, Nivedita; Poulter, Neil; Chaturvedi, Nish; Ebrahim, Shah

    2015-01-01

    Background Evidence on long term effectiveness of public health strategies for lowering blood pressure (BP) is scarce. In the Control of Blood Pressure and Risk Attenuation (COBRA) Trial, a 2 x 2 factorial, cluster randomized controlled trial, the combined home health education (HHE) and trained general practitioner (GP) intervention delivered over 2 years was more effective than no intervention (usual care) in lowering systolic BP among adults with hypertension in urban Pakistan. However, it was not clear whether the effect would be sustained after the cessation of intervention. We conducted 7 years follow-up inclusive of 5 years of post intervention period of COBRA trial participants to assess the effectiveness of the interventions on BP during extended follow-up. Methods A total of 1341 individuals 40 years or older with hypertension (systolic BP 140 mm Hg or greater, diastolic BP 90 mm Hg or greater, or already receiving treatment) were followed by trained research staff masked to randomization status. BP was measured thrice with a calibrated automated device (Omron HEM-737 IntelliSense) in the sitting position after 5 minutes of rest. BP measurements were repeated after two weeks. Generalized estimating equations (GEE) were used to analyze the primary outcome of change in systolic BP from baseline to 7- year follow-up. The multivariable model was adjusted for clustering, age at baseline, sex, baseline systolic and diastolic BP, and presence of diabetes. Findings After 7 years of follow-up, systolic BP levels among those randomised to combined HHE plus trained GP intervention were significantly lower (2.1 [4.1–0.1] mm Hg) compared to those randomised to usual care, (P = 0.04). Participants receiving the combined intervention compared to usual care had a greater reduction in LDL-cholesterol (2.7 [4.8 to 0.6] mg/dl. Conclusions The benefit in systolic BP reduction observed in the original cohort assigned to the combined intervention was attenuated but still

  11. Testing the Efficacy of OurSpace, a Brief, Group Dynamics-Based Physical Activity Intervention: A Randomized Controlled Trial

    PubMed Central

    Chalin, Patrice; Thompson, Nicholas

    2016-01-01

    Background Emerging technologies (ie, mobile phones, Internet) may be effective tools for promoting physical activity (PA). However, few interventions have provided effective means to enhance social support through these platforms. Face-to-face programs that use group dynamics-based principles of behavior change have been shown to be highly effective in enhancing social support through promoting group cohesion and PA, but to date, no studies have examined their effects in Web-based programs. Objective The aim was to explore proof of concept and test the efficacy of a brief, online group dynamics-based intervention on PA in a controlled experiment. We expected that the impact of the intervention on PA would be moderated by perceptions of cohesion and the partner’s degree of presence in the online media. Methods Participants (n=135) were randomized into same-sex dyads and randomly assigned to one of four experimental conditions: standard social support (standard), group dynamics-based–high presence, group dynamics-based–low presence, or individual control. Participants performed two sets of planking exercises (pre-post). Between sets, participants in partnered conditions interacted with a virtual partner using either a standard social support app or a group dynamics-based app (group dynamics-based–low presence and group dynamics-based–high presence), the latter of which they participated in a series of online team-building exercises. Individual participants were given an equivalent rest period between sets. To increase presence during the second set, participants in the group dynamics-based–high presence group saw a live video stream of their partner exercising. Perceptions of cohesion were measured using a modified PA Group Environment Questionnaire. Physical activity was calculated as the time persisted during set 2 after controlling for persistence in set 1. Results Perceptions of cohesion were higher in the group dynamics-based–low presence (overall

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

    PubMed Central

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

    2009-01-01

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

  13. Internal Versus External Motivation in Referral of Primary Care Patients with Depression to an Internet Support Group: Randomized Controlled Trial

    PubMed Central

    Houston, Thomas K; Fogel, Joshua; Lee, Royce; Ford, Daniel E

    2013-01-01

    Background Depressive disorders and symptoms affect more than one-third of primary care patients, many of whom do not receive or do not complete treatment. Internet-based social support from peers could sustain depression treatment engagement and adherence. We do not know whether primary care patients will accept referral to such websites nor do we know which methods of referral would be most effective. Objective We conducted a randomized clinical trial to determine whether (1) a simple generic referral card (control), (2) a patient-oriented brochure that provided examples of online postings and experience (internal motivation), or (3) a physician letter of recommendation (external motivation) would generate the greatest participation in a primary care Internet depression treatment support portal focused around an Internet support group (ISG). Methods We used 3 offline methods to identify potential participants who had not used an ISG in the past 6 months. Eligibility was determined in part by a brief structured psychiatric interview based on the Patient Health Questionnaire-9 (PHQ-9). After consent and enrollment, participants were randomly assigned to 1 of 3 groups (control, internal motivation, or external motivation). We constructed a portal to connect primary care patients to both fact-based information and an established ISG (Psycho-Babble). The ISG allowed participants to view messages and then decide if they actually wished to register there. Participation in the portal and the ISG was assessed via automated activity tracking. Results Fifty participants were assigned to the 3 groups: a motivation-neutral control group (n=18), an internal motivation group (n=19), and an external motivation group (n=13). Of these participants, 31 (62%) visited the portal; 27 (54%) visited the ISG itself. The internal motivation group showed significantly greater participation than the control group on several measures. The external motivation group spent significantly less

  14. Multicomponent Interdisciplinary Group Intervention for Self-Management of Fibromyalgia: A Mixed-Methods Randomized Controlled Trial

    PubMed Central

    Bourgault, Patricia; Lacasse, Anaïs; Marchand, Serge; Courtemanche-Harel, Roxanne; Charest, Jacques; Gaumond, Isabelle; Barcellos de Souza, Juliana; Choinière, Manon

    2015-01-01

    Background This study evaluated the efficacy of the PASSAGE Program, a structured multicomponent interdisciplinary group intervention for the self-management of FMS. Methods A mixed-methods randomized controlled trial (intervention (INT) vs. waitlist (WL)) was conducted with patients suffering from FMS. Data were collected at baseline (T0), at the end of the intervention (T1), and 3 months later (T2). The primary outcome was change in pain intensity (0-10). Secondary outcomes were fibromyalgia severity, pain interference, sleep quality, pain coping strategies, depression, health-related quality of life, patient global impression of change (PGIC), and perceived pain relief. Qualitative group interviews with a subset of patients were also conducted. Complete data from T0 to T2 were available for 43 patients. Results The intervention had a statistically significant impact on the three PGIC measures. At the end of the PASSAGE Program, the percentages of patients who perceived overall improvement in their pain levels, functioning and quality of life were significantly higher in the INT Group (73%, 55%, 77% respectively) than in the WL Group (8%, 12%, 20%). The same differences were observed 3 months post-intervention (Intervention group: 62%, 43%, 38% vs Waitlist Group: 13%, 13%, 9%). The proportion of patients who reported ≥50% pain relief was also significantly higher in the INT Group at the end of the intervention (36% vs 12%) and 3 months post-intervention (33% vs 4%). Results of the qualitative analysis were in line with the quantitative findings regarding the efficacy of the intervention. The improvement, however, was not reflected in the primary outcome and other secondary outcome measures. Conclusion The PASSAGE Program was effective in helping FMS patients gain a sense of control over their symptoms. We suggest including PGIC in future clinical trials on FMS as they appear to capture important aspects of the patients’ experience. Trial registration

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

    PubMed Central

    Renner, Walter; Berry, John W.

    2010-01-01

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

  16. Efficacy of group psychotherapy for social anxiety disorder: A meta-analysis of randomized-controlled trials.

    PubMed

    Barkowski, Sarah; Schwartze, Dominique; Strauss, Bernhard; Burlingame, Gary M; Barth, Jürgen; Rosendahl, Jenny

    2016-04-01

    Group psychotherapy for social anxiety disorder (SAD) is an established treatment supported by findings from primary studies and earlier meta-analyses. However, a comprehensive summary of the recent evidence is still pending. This meta-analysis investigates the efficacy of group psychotherapy for adult patients with SAD. A literature search identified 36 randomized-controlled trials examining 2171 patients. Available studies used mainly cognitive-behavioral group therapies (CBGT); therefore, quantitative analyses were done for CBGT. Medium to large positive effects emerged for wait list-controlled trials for specific symptomatology: g=0.84, 95% CI [0.72; 0.97] and general psychopathology: g=0.62, 95% CI [0.36; 0.89]. Group psychotherapy was also superior to common factor control conditions in alleviating symptoms of SAD, but not in improving general psychopathology. No differences appeared for direct comparisons of group psychotherapy and individual psychotherapy or pharmacotherapy. Hence, group psychotherapy for SAD is an efficacious treatment, equivalent to other treatment formats. PMID:26953823

  17. The effectiveness of group positive psychotherapy on depression and happiness in breast cancer patients: A randomized controlled trial

    PubMed Central

    Dowlatabadi, Mohammad Mehdi; Ahmadi, Seyed Mojtaba; Sorbi, Mohammad Hossein; Beiki, Omid; Razavi, Tayebeh Khademeh; Bidaki, Reza

    2016-01-01

    Background Breast cancer is one of the most prevalent cancers in women in the world. It causes fear, despair, and takes a tremendous toll on psychological status. Objective To determine the effectiveness of group positive psychotherapy on the depression and happiness of breast cancer patients. Methods This randomized controlled trial was conducted with 42 breast cancer patients in The Oncology Center at Kermanshah, Iran in 2015. The Data were gathered before intervention and ten weeks afterwards. The data were collected using Beck’s Depression Inventory (BDI-II) and Oxford’s happiness Inventory (OHI). The data were analyzed by SPSS-16, Kolmogorov-Smirnov (K-S), chi-squared, and multivariate analysis of covariance (MANCOVA). Results The results showed a significant reduction in the depression of the group on positive psychotherapy compared with the control group. Also the positive psychotherapy group experienced a significant increase in the patients’ happiness, while there was no significant increase in the control group. Conclusion The results of this research showed the effectiveness of positive psychotherapy on the reduction of mental pressure and the improvement of the mental status of breast cancer patients. This economical therapy can be used to increase patients’ psychological health. Clinical Trial Registration The trial was registered at the Iranian Registry of Clinical Trials (IRST) with the identification number IRCT2013101410063N4. Funding The authors received financial support for the research from Kermanshah University of Medical Sciences. PMID:27123227

  18. The Effectiveness of a Group Triple P with Chinese Parents Who Have a Child with Developmental Disabilities: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leung, Cynthia; Fan, Angel; Sanders, Matthew R.

    2013-01-01

    The study examined the effectiveness of Group Triple P, a Level 4 variant of the Triple P multilevel system of parenting support, with Chinese parents who had a preschool aged child with a developmental disability, using randomized controlled trial design. Participants (Intervention group: 42; Waitlist Control group: 39) completed measures on…

  19. Cluster Randomized Controlled Trial

    PubMed Central

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

    2015-01-01

    Background and Purpose— We developed a new postdischarge system of care comprising a structured assessment covering longer-term problems experienced by patients with stroke and their carers, linked to evidence-based treatment algorithms and reference guides (the longer-term stroke care system of care) to address the poor longer-term recovery experienced by many patients with stroke. Methods— A pragmatic, multicentre, cluster randomized controlled trial of this system of care. Eligible patients referred to community-based Stroke Care Coordinators were randomized to receive the new system of care or usual practice. The primary outcome was improved patient psychological well-being (General Health Questionnaire-12) at 6 months; secondary outcomes included functional outcomes for patients, carer outcomes, and cost-effectiveness. Follow-up was through self-completed postal questionnaires at 6 and 12 months. Results— Thirty-two stroke services were randomized (29 participated); 800 patients (399 control; 401 intervention) and 208 carers (100 control; 108 intervention) were recruited. In intention to treat analysis, the adjusted difference in patient General Health Questionnaire-12 mean scores at 6 months was −0.6 points (95% confidence interval, −1.8 to 0.7; P=0.394) indicating no evidence of statistically significant difference between the groups. Costs of Stroke Care Coordinator inputs, total health and social care costs, and quality-adjusted life year gains at 6 months, 12 months, and over the year were similar between the groups. Conclusions— This robust trial demonstrated no benefit in clinical or cost-effectiveness outcomes associated with the new system of care compared with usual Stroke Care Coordinator practice. Clinical Trial Registration— URL: http://www.controlled-trials.com. Unique identifier: ISRCTN 67932305. PMID:26152298

  20. Factors associated with attrition from a randomized controlled trial of meaning-centered group psychotherapy for patients with advanced cancer

    PubMed Central

    Applebaum, Allison J.; Lichtenthal, Wendy G.; Pessin, Hayley A.; Radomski, Julia N.; Gökbayrak, N. Simay; Katz, Aviva M.; Rosenfeld, Barry; Breitbart, William

    2013-01-01

    Objective The generalizability of palliative care intervention research is often limited by high rates of study attrition. This study examined factors associated with attrition from a randomized controlled trial comparing meaning-centered group psychotherapy (MCGP), an intervention designed to help advanced cancer patients sustain or enhance their sense of meaning to the supportive group psychotherapy (SGP), a standardized support group. Methods Patients with advanced solid tumor cancers (n = 153) were randomized to eight sessions of either the MCGP or SGP. They completed assessments of psychosocial, spiritual, and physical well-being pretreatment, midtreatment, and 2 months post-treatment. Attrition was assessed in terms of the percent of participants who failed to complete these assessments, and demographic, psychiatric, medical, and study-related correlates of attrition were examined for the participants in each of these categories. Results The rates of attrition at these time points were 28.1%, 17.7%, and 11.1%, respectively; 43.1% of the participants (66 of 153) completed the entire study. The most common reason for dropout was patients feeling too ill. Attrition rates did not vary significantly between study arms. The participants who dropped out pretreatment reported less financial concerns than post-treatment dropouts, and the participants who dropped out of the study midtreatment had poorer physical health than treatment completers. There were no other significant associations between attrition and any demographic, medical, psychiatric, or study-related variables. Conclusions These findings highlight the challenge of maintaining advanced cancer patients in longitudinal research and suggest the need to consider alternative approaches (e.g., telemedicine) for patients who might benefit from group interventions but are too ill to travel. PMID:21751295

  1. Intervention leads to improvements in the nutrient profile of snacks served in afterschool programs: a group randomized controlled trial.

    PubMed

    Beets, Michael W; Turner-McGrievy, Brie; Weaver, R Glenn; Huberty, Jennifer; Moore, Justin B; Ward, Dianne S; Freedman, Darcy A

    2016-09-01

    Widely adopted nutrition policies for afterschool programs (ASPs) focus on serving a fruit/vegetable daily and eliminating sugar-sweetened foods/beverages. The impact of these policies on the nutrient profile of snacks served is unclear. Evaluate changes in macro/micronutrient content of snacks served in ASPs. A 1-year group randomized controlled trial was conducted in 20 ASPs serving over 1700 elementary-age children. Intervention ASPs received a multistep adaptive framework intervention. Direct observation of snack served was collected and nutrient information determined using the USDA Nutrient Database, standardized to nutrients/100 kcal. By post-assessment, intervention ASPs reduced total kcal/snack served by 66 kcal (95CI -114 to -19 kcal) compared to control ASPs. Total fiber (+1.7 g/100 kcal), protein (+1.4 g/100 kcal), polyunsaturated fat (+1.2 g/100 kcal), phosphorous (+49.0 mg/100 kcal), potassium (+201.8 mg/100 kcal), and vitamin K (+21.5 μg/100 kcal) increased in intervention ASPs, while added sugars decreased (-5.0 g/100 kcal). Nutrition policies can lead to modest daily caloric reductions and improve select macro/micronutrients in snacks served. Long-term, these nutritional changes may contribute to healthy dietary habits. PMID:27528522

  2. Outcome From a Randomized Controlled Trial of Group Therapy for Binge Eating Disorder: Comparing Dialectical Behavior Therapy Adapted for Binge Eating to an Active Comparison Group Therapy

    PubMed Central

    Safer, Debra L.; Robinson, Athena Hagler; Jo, Booil

    2011-01-01

    Dialectical Behavior Therapy for Binge Eating Disorder (DBT-BED) aims to reduce binge eating by improving adaptive emotion-regulation skills. Preliminary findings have been promising but have only compared DBT-BED to a wait-list. To control for the hypothesized specific effects of DBT-BED, the present study compared DBT-BED to an active comparison group therapy (ACGT). Men and women (n = 101) meeting DSM-IV BED research criteria were randomly assigned to 20 group sessions of DBT-BED (n = 50) or ACGT (n = 51). DBT-BED had a significantly lower dropout rate (4%) than ACGT (33.3%). Linear Mixed Models revealed that posttreatment binge abstinence and reductions in binge frequency were achieved more quickly for DBT-BED than for ACGT (posttreatment abstinence rate = 64% for DBT-BED vs. 36% for ACGT) though differences did not persist over the 3-, 6-, and 12-month follow-up assessments (e.g., 12-month follow-up abstinence rate = 64% for DBT-BED vs. 56% for ACGT). Secondary outcome measures revealed no sustained impact on emotion regulation. Although both DBT-BED and ACGT reduced binge eating, DBT-BED showed significantly fewer dropouts and greater initial efficacy (e.g., at posttreatment) than ACGT. The lack of differential findings over follow-up suggests that the hypothesized specific effects of DBT-BED do not show long-term impact beyond those attributable to nonspecific common therapeutic factors. PMID:20171332

  3. A Randomized Controlled Trial of a Group Motivational Interviewing Intervention for Adolescents with a First Time Alcohol or Drug Offense

    PubMed Central

    D’Amico, Elizabeth J.; Hunter, Sarah B.; Miles, Jeremy N.V.; Ewing, Brett A.; Osilla, Karen Chan

    2013-01-01

    Group Motivational Interviewing (MI) interventions that target youth at-risk for alcohol and other drug (AOD) use may prevent future negative consequences. Youth in a teen court setting (n=193; 67% male, 45% Hispanic; mean age 16.6 (SD = 1.05) were randomized to receive either a group MI intervention, Free Talk, or usual care (UC). We examined client acceptance, intervention feasibility and conducted a preliminary outcome evaluation. Free Talk teens reported higher quality and satisfaction ratings, and MI integrity scores were higher for Free Talk groups. AOD use and delinquency decreased for both groups at three months, and 12-month recidivism rates were lower but not significantly different for the Free Talk group compared to UC. Results contribute to emerging literature on MI in a group setting. A longer term follow-up is warranted. PMID:23891459

  4. Variations of high frequency parameter of heart rate variability following osteopathic manipulative treatment in healthy subjects compared to control group and sham therapy: randomized controlled trial

    PubMed Central

    Ruffini, Nuria; D'Alessandro, Giandomenico; Mariani, Nicolò; Pollastrelli, Alberto; Cardinali, Lucia; Cerritelli, Francesco

    2015-01-01

    Context: Heart Rate Variability (HRV) indicates how heart rate changes in response to inner and external stimuli. HRV is linked to health status and it is an indirect marker of the autonomic nervous system (ANS) function. Objective: To investigate the influence of osteopathic manipulative treatment (OMT) on cardiac autonomic modulation in healthy subjects, compared with sham therapy and control group. Methods: Sixty-six healthy subjects, both male and female, were included in the present 3-armed randomized placebo controlled within subject cross-over single blinded study. Participants were asymptomatic adults (26.7 ± 8.4 y, 51% male, BMI 18.5 ± 4.8), both smokers and non-smokers and not on medications. At enrollment subjects were randomized in three groups: A, B, C. Standardized structural evaluation followed by a patient need-based osteopathic treatment was performed in the first session of group A and in the second session of group B. Standardized evaluation followed by a protocoled sham treatment was provided in the second session of group A and in the first session of group B. No intervention was performed in the two sessions of group C, acting as a time-control. The trial was registered on clinicaltrials.gov identifier: NCT01908920. Main Outcomes Measures: HRV was calculated from electrocardiography before, during and after the intervention, for a total amount time of 25 min and considering frequency domain as well as linear and non-linear methods as outcome measures. Results: OMT engendered a statistically significant increase of parasympathetic activity, as shown by High Frequency power (p < 0.001), expressed in normalized and absolute unit, and possibly decrease of sympathetic activity, as revealed by Low Frequency power (p < 0.01); results also showed a reduction of Low Frequency/High Frequency ratio (p < 0.001) and Detrended fluctuation scaling exponent (p < 0.05). Conclusions: Findings suggested that OMT can influence ANS activity increasing

  5. 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…

  6. Longitudinal Effects of Coping on Outcome in a Randomized Controlled Trial of a Group Intervention for HIV-Positive Adults with AIDS-Related Bereavement

    ERIC Educational Resources Information Center

    Hansen, Nathan B.; Tarakeshwar, Nalini; Ghebremichael, Musie; Zhang, Heping; Kochman, Arlene; Sikkema, Kathleen J.

    2006-01-01

    This study examined the longitudinal effects of coping on outcome one year following completion of a randomized, controlled trial of a group coping intervention for AIDS-related bereavement. Bereaved HIV-positive participants (N = 267) were administered measures of grief, psychiatric distress, quality of life, and coping at baseline,…

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

    ERIC Educational Resources Information Center

    Bogenschutz, Matthew; Nord, Derek; Hewitt, Amy

    2015-01-01

    Turnover among direct support professionals (DSPs) in community support settings for individuals with intellectual and developmental disabilities (IDD) has been regarded as a challenge since tracking of this workforce began in the 1980s. This study utilized a group randomized controlled design to test the effects of a competency-based training…

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

    PubMed

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

    2012-03-01

    A resource-building group intervention was developed to enhance career management, mental health, and job retention in work organizations. The in-company training program provided employees with better preparedness to manage their own careers. The program activities were universally implemented using an organization-level, 2-trainer model with trainers from the human resources management and occupational health services. The study was a within-organizations, randomly assigned field experimental study; it investigated the impacts of the intervention on immediate career management preparedness and later mental health and intentions to retire early. A total of 718 eligible individuals returned a questionnaire in 17 organizations and became voluntary participants. The respondents were randomly assigned to either an intervention (N = 369) or a comparison group (N = 349). Those in the intervention group were invited to group intervention workshops, whereas those in the comparison group received printed information about career and health-related issues. The 7-month follow-up results showed that the program significantly decreased depressive symptoms and intentions to retire early and increased mental resources among the group participants compared to the others. The mediation analyses demonstrated that the increase in career management preparedness as a proximal impact of the intervention mediated the longer term mental health effects. Those who benefited most from the intervention as regards their mental health were employees with elevated levels of depression or exhaustion and younger employees, implying additional benefits of a more targeted use of the intervention. The results demonstrated the benefits of the enhancement of individual-level career management and resilience resources as career and health promotion practice in work organizations. PMID:21942405

  9. Effects of a Topical Saffron (Crocus sativus L) Gel on Erectile Dysfunction in Diabetics: A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Trial.

    PubMed

    Mohammadzadeh-Moghadam, Hossein; Nazari, Seyed Mohammad; Shamsa, Ali; Kamalinejad, Mohammad; Esmaeeli, Habibollah; Asadpour, Amir Abbas; Khajavi, Abdoljavad

    2015-10-01

    Erectile dysfunction is a man's persistent or recurrent inability to achieve and maintain erection for a satisfactory sexual relationship. As diabetes is a major risk factor for erectile dysfunction, the prevalence of erectile dysfunction among diabetic men has been reported as 35% to 90%. This randomized, parallel-group, double-blind, placebo-controlled trial investigated the effects of a topical saffron (Crocus sativus L) gel on erectile dysfunction in diabetic men. Patients were randomly allocated to 2 equal groups (with 25 patients each). The intervention group was treated with topical saffron, and the control received a similar treatment with placebo. The 2 groups were assessed using the International Index of Erectile Function Questionnaire before the intervention and 1 month after the intervention. Compared to placebo, the prepared saffron gel could significantly improve erectile dysfunction in diabetic patients (P < .001). This preliminary evidence suggests that saffron can be considered as a treatment option for diabetic men with erectile dysfunction. PMID:25948674

  10. A randomized, controlled clinical trial of standard, group and brief cognitive-behavioral therapy for panic disorder with agoraphobia: a two-year follow-up.

    PubMed

    Marchand, André; Roberge, Pasquale; Primiano, Sandra; Germain, Vanessa

    2009-12-01

    A randomized controlled clinical trial with a wait-list control group was conducted to examine the effectiveness of three modalities (brief, group, and standard) of cognitive-behavioral treatment (CBT) for panic disorder with agoraphobia. A total of 100 participants meeting DSM-IV criteria were randomly assigned to each treatment condition: a 14-session standard CBT (n=33), a 14-session group CBT (n=35) and a 7-session brief CBT (n=32). Participants received a self-study manual and were assigned weekly readings and exercises. The results indicate that regardless of the treatment condition, CBT for moderate to severe PDA is beneficial in medium and long term. To this effect, all three-treatment conditions significantly reduced the intensity of symptoms, increased participants' quality of life, offered high effect sizes, superior maintenance of gains over time, and lower rates of relapse, compared to the wait-list control. PMID:19709851

  11. The Effectiveness of Group Cognitive Behavioral Therapy in Treating Obsessive-Compulsive Disorder in Women with Multiple Sclerosis (MS): A randomized double-blind controlled trial

    PubMed Central

    Sayyah, Mehdi; Bagheri, Parisa; Karimi, Negar; Ghasemzadeh, Azizreza

    2016-01-01

    Background Obsessive-compulsive disorder (OCD) is one of the most prevalent psychiatric disorders and can cause problems for individuals in all aspects of life, including social and personal dimensions. Objective To study the effect of group cognitive-behavioral therapy on the reduction of OCD symptoms in female participants with multiple sclerosis (MS). Methods This double-blind randomized control trial was conducted from May 2012 to December 2014. The participants included 75 patients with MS who suffered from OCD and were referred to the Loghman Hakim and Imam Khomeini hospitals in Tehran, Iran. Thirty participants had been diagnosed through Yale-Brown Obsessive-Compulsive Symptoms (Y-BOCS). The participants were randomly divided into an experimental group (n=15) and a control group (n=15). Eleven sessions of cognitive-behavioral therapy were provided for the experimental group. Patients in the control group continued with their normal living. Hypotheses were tested using an analysis of covariance (ANCOVA). Results A significant reduction was found in the experimental group’s obsessive-compulsive symptoms after cognitive-behavioral therapy (p<0.001). In addition, mean scores for participants in the experimental group were significantly lower than for those in the control group (p=0.000). Conclusion It can be inferred that cognitive-behavioral therapy could considerably reduce OCD symptoms in women with MS. The application of this method by therapists, especially Iranian clinicians, is recommended. PMID:27279999

  12. Evaluating a community-based early childhood education and development program in Indonesia: study protocol for a pragmatic cluster randomized controlled trial with supplementary matched control group

    PubMed Central

    2013-01-01

    Background This paper presents the study protocol for a pragmatic cluster randomized controlled trial (RCT) with a supplementary matched control group. The aim of the trial is to evaluate a community-based early education and development program launched by the Government of Indonesia. The program was developed in collaboration with the World Bank with a total budget of US$127.7 million, and targets an estimated 738,000 children aged 0 to 6 years living in approximately 6,000 poor communities. The aim of the program is to increase access to early childhood services with the secondary aim of improving school readiness. Methods/Design The study is being conducted across nine districts. The baseline survey contained 310 villages, of which 100 were originally allocated to the intervention arm, 20 originally allocated to a 9-month delay staggered start, 100 originally allocated to an 18-month delay staggered start and 90 allocated to a matched control group (no intervention). The study consists of two cohorts, one comprising children aged 12 to 23 months and the other comprising children aged 48 to 59 months at baseline. The data collection instruments include child observations and task/game-based assessments as well as a questionnaire suite, village head questionnaire, service level questionnaires, household questionnaire, and child caretaker questionnaire. The baseline survey was conducted from March to April 2009, midline was conducted from April to August 2010 and endline conducted early 2013. The resultant participation rates at both the district and village levels were 90%. At the child level, the participation rate was 99.92%. The retention rate at the child level at midline was 99.67%. Discussion This protocol paper provides a detailed record of the trial design including a discussion regarding difficulties faced with compliance to the randomization, compliance to the dispersion schedule of community block grants, and procurement delays for baseline and midline

  13. Effectiveness and cost-effectiveness of meaning-centered group psychotherapy in cancer survivors: protocol of a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Meaning-focused coping may be at the core of adequate adjustment to life after cancer. Cancer survivors who experience their life as meaningful are better adjusted, have better quality of life and psychological functioning. Meaning-Centered Group Psychotherapy for Cancer Survivors (MCGP-CS) was designed to help patients to sustain or enhance a sense of meaning and purpose in their lives. The aim of the proposed study is to evaluate the effectiveness and cost-effectiveness of MCGP-CS. Methods/Design Survivors diagnosed with cancer in the last 5 years and treated with curative intent, are recruited via several hospitals in the Netherlands. After screening, 168 survivors are randomly assigned to one of the three study arms: 1. Meaning-Centered Group Psychotherapy (MCGP-CS) 2. Supportive group psychotherapy (SGP) 3. Care as usual (CAU). Baseline assessment takes place before randomisation, with follow up assessments post-intervention and at 3, 6 and 12 months follow-up. Primary outcome is meaning making (PMP, PTGI, SPWB). Secondary outcome measures address quality of life (EORTC-30), anxiety and depression (HADS), hopelessness (BHS), optimism (LOT-R), adjustment to cancer (MAC), and costs (TIC-P, EQ-5D, PRODISQ). Discussion Meaning-focused coping is key to adjustment to life after cancer, however, there is a lack of evidence based psychological interventions in this area. Many cancer survivors experience feelings of loneliness and alienation, and have a need for peer support, therefore a group method in particular, can be beneficial for sustaining or enhancing a sense of meaning. If this MCGP-CS is effective for cancer survivors, it can be implemented in the practice of psycho-oncology care. Trial registration Netherlands Trial Register, NTR3571 PMID:24467861

  14. Epidemiological evaluation quality of life in patients suffering from early rheumatoid arthritis: a pragmatic, prospective, randomized, blind allocation controlled of a modular program group intervention

    PubMed Central

    2015-01-01

    OBJECTIVES: Epidemiology has taken on new roles in the management of health care services. In this study, we developed a non-pharmacological self-management modular program group intervention and evaluated its efficacy as an adjunct therapy in patients suffering from early rheumatoid arthritis (RA). METHODS: Patients were randomized to either participate in a non-equivalent intervention group along with the standard of care or only receive standard-of-care treatment at a community rheumatology center. The outcomes measured were a pain visual analog scale (VAS), patient general health (GH) on a VAS, and the Short Form 36 Health Survey version 2 scale measuring quality of life. These parameters were evaluated in the first week to obtain baseline values, and at 20, 32, 48, and 60 weeks to evaluate the efficacy of the intervention group. RESULTS: The patients were randomized, with 100 patients in the intervention group and 106 in the control group. The intervention and control groups were similar with regard to the percentage of women (86% vs. 89.6%), tobacco usage (25% vs. 19.8%), mean age (42.6±13.2 years vs. 46.6±10.9 years), and disease duration (15.3±6.7 months vs. 14.5±6.6 months). The mean outcomes were significantly different between the two groups, and post-hoc pairwise analysis demonstrated significant deterioration in the control group in contrast to improvement in the intervention group at the second, third, fourth, and fifth evaluations. Improvements were often seen as early as the 12-week and 24-week follow-up visits. CONCLUSIONS: Epidemiology contributes to the evaluation of how well specific therapies or other health interventions prevent or control health problems. The modular program group intervention implemented in this study appears to be a suitable and feasible method to facilitate much more comprehensive management of early RA in socioeconomically challenged communities. PMID:26552423

  15. The effect of adding group-based counselling to individual lifestyle counselling on changes in dietary intake. The Inter99 study – a randomized controlled trial

    PubMed Central

    Toft, Ulla; Kristoffersen, Lis; Ladelund, Steen; Ovesen, Lars; Lau, Cathrine; Pisinger, Charlotta; Smith, Lisa von Huth; Borch-Johnsen, Knut; Jørgensen, Torben

    2008-01-01

    Background Few studies have investigated the specific effect of single intervention components in randomized controlled trials. The purpose was to investigate the effect of adding group-based diet and exercise counselling to individual life-style counselling on long-term changes in dietary habits. Methods The study was a randomized controlled intervention study. From a general Danish population, aged 30 to 60 years (n = 61,301), two random sample were drawn (group A, n = 11,708; group B, n = 1,308). Subjects were invited for a health screening program. Participation rate was 52.5%. All participants received individual life-style counselling. Individuals at high risk of ischemic heart disease in group A were furthermore offered group-based life-style counselling. The intervention was repeated for high-risk individuals after one and three years. At five-year follow-up all participants were invited for a health examination. High risk individuals were included in this study (n = 2 356) and changes in dietary intake were analyzed using multilevel linear regression analyses. Results At one-year follow-up group A had significantly increased the unsaturated/saturated fat ratio compared to group B and in men a significantly greater decrease in saturated fat intake was found in group A compared to group B (net change: -1.13 E%; P = 0.003). No differences were found between group A and B at three-year follow-up. At five-year follow-up group A had significantly increased the unsaturated/saturated fat ratio (net change: 0.09; P = 0.01) and the fish intake compared to group B (net change: 5.4 g/day; P = 0.05). Further, in men a non-significant tendency of a greater decrease was found at five year follow-up in group A compared to group B (net change: -0.68 E%; P = 0.10). The intake of fibre and vegetables increased in both groups, however, no significant difference was found between the groups. No differences between groups were found for saturated fat intake in women. Conclusion

  16. One-Year Follow-Up of the Effectiveness of Cognitive Behavioral Group Therapy for Patients' Depression: A Randomized, Single-Blinded, Controlled Study

    PubMed Central

    Chiang, Kai-Jo; Chen, Tsai-Hui; Hsieh, Hsiu-Tsu; Tsai, Jui-Chen; Ou, Keng-Liang; Chou, Kuei-Ru

    2015-01-01

    The aim of the study was to investigate the long-term (one year) effectiveness of a 12-session weekly cognitive behavior group therapy (CBGT) on patients with depression. This was a single-blind randomized controlled study with a 2-arm parallel group design. Eighty-one subjects were randomly assigned to 12 sessions intervention group (CBGT) or control group (usual outpatient psychiatric care group) and 62 completed the study. The primary outcome was depression measured with Beck Depression Inventory (BDI-II) and Hamilton Rating Scale for Depression (HRSD). The secondary outcomes were automatic thoughts measured by automatic thoughts questionnaire (ATQ). Both groups were evaluated at the pretest (before 2 weeks), posttest (after 12 therapy sessions), and short- (3 months), medium- (6 months), and long-term (12 months) follow-up. After receiving CBGT, the experimental group had a statistically significant reduction in the BDI-II from 40.30 at baseline to 17.82 points at session eight and to 10.17 points at postintervention (P < 0.001). Similar effects were seen on the HRSD. ATQ significantly decreased at the 12th session, 6 months after sessions, and 1 year after the sessions ended (P < 0.001). We concluded that CBGT is effective for reducing depression and continued to be effective at 1 year of follow-up. PMID:26380359

  17. Randomized Interdependent Group Contingencies: Group Reinforcement with a Twist.

    ERIC Educational Resources Information Center

    Kelshaw-Levering, Kimberly; Sterling-Turner, Heather E.; Henry, Jennifer R.; Skinner, Christopher H.

    2000-01-01

    Examines the effects of randomizing components of an interdependent group contingency procedure on the target behavior of 12 second-grade students. Study compares levels of disruptive behavior across baseline, an intervention phase with only randomized reinforcers, and an intervention phase with all components randomized. Results suggest that both…

  18. The effects and costs of the universal parent group program – all children in focus: a study protocol for a randomized wait-list controlled trial

    PubMed Central

    2013-01-01

    Background In recent decades, parents have been involved in programs that aim to improve parenting style and reduce child behavior problems. Research of preventive parenting programs has shown that these interventions generally have a positive influence on both parents and children. However, to our knowledge there is a gap in the scientific literature when it comes to randomized controlled trials of brief, manual-based structured programs which address general parenting among the population, and focus on promoting health. A four-session universal health promotion parent group program named All Children in Focus was developed. It aims at promoting parental competence and children’s positive development with the parent–child relationship as the target. There is currently no randomized controlled trial existing of the program. Methods/Design A prospective multicenter randomized wait-list controlled trial is being conducted. Approximately 600 parents with children ranging in age from 3–12 years have been recruited in eleven municipalities and city districts in the County of Stockholm, Sweden. Parents are randomized at baseline to an intervention group, which receives the program directly, or to a waiting-list control group, which participates in the program six months later. Changes in parenting and child health and development are assessed with measures immediately post-intervention and six months after the baseline. Observations of a minor group of parents and children are conducted to explore possible relations between parental reports and observed behaviors, as well as changes in the interaction between parent and child. Further, data collected within the evaluation will also be applied to evaluate the possible cost-effectiveness of the program. Discussion This paper describes a study protocol of a randomized controlled trial. Except for the quantitative outcome measures to evaluate the effectiveness of All Children in Focus, this protocol also describes

  19. Competency-Based Training and Worker Turnover in Community Supports for People With IDD: Results From a Group Randomized Controlled Study.

    PubMed

    Bogenschutz, Matthew; Nord, Derek; Hewitt, Amy

    2015-06-01

    Turnover among direct support professionals (DSPs) in community support settings for individuals with intellectual and developmental disabilities (IDD) has been regarded as a challenge since tracking of this workforce began in the 1980s. This study utilized a group randomized controlled design to test the effects of a competency-based training intervention for DSPs on site-level turnover rates over a one year period. Results suggested that, compared with the control group, sites receiving the training intervention experienced a significant decrease in annual turnover, when multiple factors were controlled. Implications, including the importance of considering quality training as a long term organizational investment and intervention to reduce turnover, are discussed. PMID:26107852

  20. Pre-consultation educational group intervention to improve shared decision-making in postmastectomy breast reconstruction: study protocol for a pilot randomized controlled trial

    PubMed Central

    2013-01-01

    Background The Pre-Consultation Educational Group Intervention pilot study seeks to assess the feasibility and inform the optimal design for a definitive randomized controlled trial that aims to improve the quality of decision-making in postmastectomy breast reconstruction patients. Methods/design This is a mixed-methods pilot feasibility randomized controlled trial that will follow a single-center, 1:1 allocation, two-arm parallel group superiority design. Setting: The University Health Network, a tertiary care cancer center in Toronto, Canada. Participants: Adult women referred to one of three plastic and reconstructive surgeons for delayed breast reconstruction or prophylactic mastectomy with immediate breast reconstruction. Intervention: We designed a multi-disciplinary educational group workshop that incorporates the key components of shared decision-making, decision-support, and psychosocial support for cancer survivors prior to the initial surgical consult. The intervention consists of didactic lectures by a plastic surgeon and nurse specialist on breast reconstruction choices, pre- and postoperative care; a value-clarification exercise led by a social worker; and discussions with a breast reconstruction patient. Control: Usual care includes access to an informational booklet, website, and patient volunteer if desired. Outcomes: Expected pilot outcomes include feasibility, recruitment, and retention targets. Acceptability of intervention and full trial outcomes will be established through qualitative interviews. Trial outcomes will include decision-quality measures, patient-reported outcomes, and service outcomes, and the treatment effect estimate and variability will be used to inform the sample size calculation for a full trial. Discussion Our pilot study seeks to identify the (1) feasibility, acceptability, and design of a definitive RCT and (2) the optimal content and delivery of our proposed educational group intervention. Thirty patients have been

  1. Decision aid on breast cancer screening reduces attendance rate: results of a large-scale, randomized, controlled study by the DECIDEO group.

    PubMed

    Bourmaud, Aurelie; Soler-Michel, Patricia; Oriol, Mathieu; Regnier, Véronique; Tinquaut, Fabien; Nourissat, Alice; Bremond, Alain; Moumjid, Nora; Chauvin, Franck

    2016-03-15

    Controversies regarding the benefits of breast cancer screening programs have led to the promotion of new strategies taking into account individual preferences, such as decision aid. The aim of this study was to assess the impact of a decision aid leaflet on the participation of women invited to participate in a national breast cancer screening program. This Randomized, multicentre, controlled trial. Women aged 50 to 74 years, were randomly assigned to receive either a decision aid or the usual invitation letter. Primary outcome was the participation rate 12 months after the invitation. 16 000 women were randomized and 15 844 included in the modified intention-to-treat analysis. The participation rate in the intervention group was 40.25% (3174/7885 women) compared with 42.13% (3353/7959) in the control group (p = 0.02). Previous attendance for screening (RR = 6.24; [95%IC: 5.75-6.77]; p < 0.0001) and medium household income (RR = 1.05; [95%IC: 1.01-1.09]; p = 0.0074) were independently associated with attendance for screening. This large-scale study demonstrates that the decision aid reduced the participation rate. The decision aid activate the decision making process of women toward non-attendance to screening. These results show the importance of promoting informed patient choices, especially when those choices cannot be anticipated. PMID:26883201

  2. Decision aid on breast cancer screening reduces attendance rate: results of a large-scale, randomized, controlled study by the DECIDEO group

    PubMed Central

    Bourmaud, Aurelie; Soler-Michel, Patricia; Oriol, Mathieu; Regnier, Véronique; Tinquaut, Fabien; Nourissat, Alice; Bremond, Alain; Moumjid, Nora; Chauvin, Franck

    2016-01-01

    Controversies regarding the benefits of breast cancer screening programs have led to the promotion of new strategies taking into account individual preferences, such as decision aid. The aim of this study was to assess the impact of a decision aid leaflet on the participation of women invited to participate in a national breast cancer screening program. This Randomized, multicentre, controlled trial. Women aged 50 to 74 years, were randomly assigned to receive either a decision aid or the usual invitation letter. Primary outcome was the participation rate 12 months after the invitation. 16 000 women were randomized and 15 844 included in the modified intention-to-treat analysis. The participation rate in the intervention group was 40.25% (3174/7885 women) compared with 42.13% (3353/7959) in the control group (p = 0.02). Previous attendance for screening (RR = 6.24; [95%IC: 5.75-6.77]; p < 0.0001) and medium household income (RR = 1.05; [95%IC: 1.01-1.09]; p = 0.0074) were independently associated with attendance for screening. This large-scale study demonstrates that the decision aid reduced the participation rate. The decision aid activate the decision making process of women toward non-attendance to screening. These results show the importance of promoting informed patient choices, especially when those choices cannot be anticipated. PMID:26883201

  3. Reducing antibiotic prescriptions for respiratory tract infections in family practice: results of a cluster randomized controlled trial evaluating a multifaceted peer-group-based intervention.

    PubMed

    Vervloet, Marcia; Meulepas, Marianne A; Cals, Jochen W L; Eimers, Mariëtta; van der Hoek, Lucas S; van Dijk, Liset

    2016-01-01

    Irrational antibiotic use for respiratory tract infections (RTI) is a major driver of bacterial resistance. The aim of this study was to evaluate the effect of a multifaceted peer-group based intervention aiming to reduce RTI-related antibiotic prescriptions in family practice. This was a cluster randomized controlled trial with pre- and follow-up measurement. The intervention was implemented through PharmacoTherapy Audit Meetings (PTAM) in which family physicians (FPs) and pharmacists collaborate. Four PTAM groups received the intervention consisting of: (1) FP communication skills training, including communication about delayed prescribing; (2) implementation of antibiotic prescribing agreements in FPs' Electronic Prescribing Systems; (3) quarterly feedback figures for FPs. Four other PTAM groups were matched controls. Primary outcome measure was the number of RTI-related antibiotic prescriptions after the intervention, assessed with multilevel linear regression analyses. Total number and number of prescriptions stratified by age (under/over 12 years) were analysed. At baseline, the average total number of RTI-related antibiotic prescriptions per 1,000 patients was 207.9 and 176.7 in the intervention and control PTAM groups, respectively. At follow-up, FPs in both the intervention and control groups prescribed significantly less antibiotics. For adolescents and adults, the drop in number of antibiotic prescription was significantly larger in the intervention groups (-27.8 per 1,000 patients) than the control groups (-7.2 per 1,000 patients; P<0.05). This multifaceted peer-group-based intervention was effective in reducing the number of RTI-related antibiotic prescriptions for adolescents and adults. To affect antibiotic prescribing in children other methods are needed. PMID:26845640

  4. Reducing antibiotic prescriptions for respiratory tract infections in family practice: results of a cluster randomized controlled trial evaluating a multifaceted peer-group-based intervention

    PubMed Central

    Vervloet, Marcia; Meulepas, Marianne A; Cals, Jochen W L; Eimers, Mariëtta; van der Hoek, Lucas S; van Dijk, Liset

    2016-01-01

    Irrational antibiotic use for respiratory tract infections (RTI) is a major driver of bacterial resistance. The aim of this study was to evaluate the effect of a multifaceted peer-group based intervention aiming to reduce RTI-related antibiotic prescriptions in family practice. This was a cluster randomized controlled trial with pre- and follow-up measurement. The intervention was implemented through PharmacoTherapy Audit Meetings (PTAM) in which family physicians (FPs) and pharmacists collaborate. Four PTAM groups received the intervention consisting of: (1) FP communication skills training, including communication about delayed prescribing; (2) implementation of antibiotic prescribing agreements in FPs’ Electronic Prescribing Systems; (3) quarterly feedback figures for FPs. Four other PTAM groups were matched controls. Primary outcome measure was the number of RTI-related antibiotic prescriptions after the intervention, assessed with multilevel linear regression analyses. Total number and number of prescriptions stratified by age (under/over 12 years) were analysed. At baseline, the average total number of RTI-related antibiotic prescriptions per 1,000 patients was 207.9 and 176.7 in the intervention and control PTAM groups, respectively. At follow-up, FPs in both the intervention and control groups prescribed significantly less antibiotics. For adolescents and adults, the drop in number of antibiotic prescription was significantly larger in the intervention groups (−27.8 per 1,000 patients) than the control groups (−7.2 per 1,000 patients; P<0.05). This multifaceted peer-group-based intervention was effective in reducing the number of RTI-related antibiotic prescriptions for adolescents and adults. To affect antibiotic prescribing in children other methods are needed. PMID:26845640

  5. The effect of motivational lung age feedback on short-term quit rates in smokers seeking intensive group treatment: a randomized controlled pilot study*

    PubMed Central

    Foulds, Jonathan; Veldheer, Susan; Hrabovsky, Shari; Yingst, Jessica; Sciamanna, Chris; Chen, Gang; Maccani, Jennifer Z. J.; Berg, Arthur

    2016-01-01

    Background A brief “Lung Age” feedback intervention has shown promise for personalizing the health impact of smoking and promoting cessation in unselected smokers. Now that many healthcare organizations provide face-to-face cessation services, it is reasonable to ask whether such motivational feedback of lung function tests might improve treatment compliance and cessation rates in smokers wanting to quit. This study assessed effects of baseline motivational spirometry-based “Lung Age” feedback on treatment compliance and tobacco abstinence at 28-day follow-up. Methods This randomized controlled pilot study took place in Penn State University-affiliated outpatient medical practices. Participants were 225 adult smokers (≥ 5 cigarettes/day) willing to attend tobacco dependence treatment. At assessment lung function (FEV-1) and exhaled carbon-monoxide (CO) were assessed. The Intervention group (n=120) were randomly allocated to receive motivational “Lung Age” feedback estimated by FEV-1 and on exhaled CO; Control group (n=105) received minimal feedback. Participants were offered 6 weekly group smoking cessation sessions and nicotine patches and followed-up 28 days after target quit date. The primary outcome measure was self-reported 7-day tobacco abstinence, confirmed by CO<10ppm at 28-day follow-up. Results Quit rates were similar at follow-up (Intervention 50.8%; Control 52.4%; p=0.65) after controlling for abstinence predictors. Group attendance and patch use were similar. Among those attending follow-up (n=164, 73%), a greater proportion of the Intervention group had improved lung function (67% v. 46%; p=0.0083). Conclusions Baseline Lung Age feedback did not improve quit rates or compliance at 28-day follow-up in smokers seeking intensive treatment. This study was registered at ClinicalTrials.gov (identifier: NCT01980485). PMID:26051163

  6. Covariate-based constrained randomization of group-randomized trials.

    PubMed

    Moulton, Lawrence H

    2004-01-01

    Group-randomized study designs are useful when individually randomized designs are either not possible, or will not be able to estimate the parameters of interest. Blocked and/or stratified (for example, pair-matched) designs have been used, and their properties statistically evaluated by many researchers. Group-randomized trials often have small numbers of experimental units, and strong, geographically induced between-unit correlation, which increase the chance of obtaining a "bad" randomization outcome. This article describes a procedure--random selection from a list of acceptable allocations--to allocate treatment conditions in a way that ensures balance on relevant covariates. Numerous individual- and group-level covariates can be balanced using exact or caliper criteria. Simulation results indicate that this method has good frequency properties, but some care may be needed not to overly constrain the randomization. There is a trade-off between achieving good balance through a highly constrained design, and jeopardizing the appearance of impartiality of the investigator and potentially departing from the nominal Type I error. PMID:16279255

  7. Manage at work: a randomized, controlled trial of a self-management group intervention to overcome workplace challenges associated with chronic physical health conditions

    PubMed Central

    2014-01-01

    Background The percentage of older and chronically ill workers is increasing rapidly in the US and in many other countries, but few interventions are available to help employees overcome the workplace challenges of chronic pain and other physical health conditions. While most workers are eligible for job accommodation and disability compensation benefits, other workplace strategies might improve individual-level coping and problem solving to prevent work disability. In this study, we hypothesize that an employer-sponsored group intervention program employing self-management principles may improve worker engagement and reduce functional limitation associated with chronic disorders. Methods In a randomized controlled trial (RCT), workers participating in an employer-sponsored self-management group intervention will be compared with a no-treatment (wait list) control condition. Volunteer employees (n = 300) will be recruited from five participating employers and randomly assigned to intervention or control. Participants in the intervention arm will attend facilitated group workshop sessions at work (10 hours total) to explore methods for improving comfort, adjusting work habits, communicating needs effectively, applying systematic problem solving, and dealing with negative thoughts and emotions about work. Work engagement and work limitation are the principal outcomes. Secondary outcomes include fatigue, job satisfaction, self-efficacy, turnover intention, sickness absence, and health care utilization. Measurements will be taken at baseline, 6-, and 12-month follow-up. A process evaluation will be performed alongside the randomized trial. Discussion This study will be most relevant for organizations and occupational settings where some degree of job flexibility, leeway, and decision-making autonomy can be afforded to affected workers. The study design will provide initial assessment of a novel workplace approach and to understand factors affecting its feasibility

  8. Efficacy of Cognitive Behavioral Therapy for Insomnia in Adolescents: A Randomized Controlled Trial with Internet Therapy, Group Therapy and A Waiting List Condition

    PubMed Central

    de Bruin, Eduard J.; Bögels, Susan M.; Oort, Frans J.; Meijer, Anne Marie

    2015-01-01

    Study Objectives: To investigate the efficacy of cognitive behavioral therapy for insomnia (CBTI) in adolescents. Design: A randomized controlled trial of CBTI in group therapy (GT), guided internet therapy (IT), and a waiting list (WL), with assessments at baseline, directly after treatment (post-test), and at 2 months follow-up. Setting: Diagnostic interviews were held at the laboratory of the Research Institute of Child Development and Education at the University of Amsterdam. Treatment for GT occurred at the mental health care center UvAMinds in Amsterdam, the Netherlands. Participants: One hundred sixteen adolescents (mean age = 15.6 y, SD = 1.6 y, 25% males) meeting DSM-IV criteria for insomnia, were randomized to IT, GT, or WL. Interventions: CBTI of 6 weekly sessions, consisted of psychoeducation, sleep hygiene, restriction of time in bed, stimulus control, cognitive therapy, and relaxation techniques. GT was conducted in groups of 6 to 8 adolescents, guided by 2 trained sleep therapists. IT was applied through an online guided self-help website with programmed instructions and written feedback from a trained sleep therapist. Measurements and Results: Sleep was measured with actigraphy and sleep logs for 7 consecutive days. Symptoms of insomnia and chronic sleep reduction were measured with questionnaires. Results showed that adolescents in both IT and GT, compared to WL, improved significantly on sleep efficiency, sleep onset latency, wake after sleep onset, and total sleep time at post-test, and improvements were maintained at follow-up. Most of these improvements were found in both objective and subjective measures. Furthermore, insomnia complaints and symptoms of chronic sleep reduction also decreased significantly in both treatment conditions compared to WL. Effect sizes for improvements ranged from medium to large. A greater proportion of participants from the treatment conditions showed high end-state functioning and clinically significant

  9. Using WhatsApp and Facebook Online Social Groups for Smoking Relapse Prevention for Recent Quitters: A Pilot Pragmatic Cluster Randomized Controlled Trial

    PubMed Central

    Chan, Ching Han Helen; Lai, Chi-Keung Jonah; Chan, Wai Fung Vivian; Wang, Man Ping; Li, Ho Cheung William; Chan, Sophia Siu Chee; Lam, Tai-Hing

    2015-01-01

    Background Quit attempters often have episodes of smoking relapse before they eventually quit. Interactive text messaging through mobile phones has been shown to increase abstinence. This service can be potentially applied on the platform of a social networking service to help quitters maintain abstinence. Objective Our aim was to determine if the group discussion and reminders via the WhatsApp or Facebook social group were effective to prevent smoking relapse in quitters who had stopped smoking recently. Methods This was a single-blinded, parallel, 3-arm pilot cluster randomized controlled trial allocating recent quitters, who had completed an 8-week treatment and reported abstinence for at least 7 days, to WhatsApp (n=42), Facebook (n=40), and a control group (n=54). The 2 intervention groups participated in a 2-month online group discussion with either WhatsApp or Facebook moderated by a trained smoking cessation counselor and received a self-help booklet on smoking cessation. The control group only received the booklet. The primary outcome was the 2- and 6-month relapse rates, defined as the proportion of participants who smoked at least 5 cigarettes in 3 consecutive days. Results Fewer participants in the WhatsApp group (17%, 7/42) reported relapse than the control group (42.6%, 23/54) at 2-month (OR 0.27, 95% CI 0.10-0.71) and 6-month (40.5%, 17/42 vs 61.1%, 33/54; OR 0.43, 95% CI 0.19-0.99) follow-ups. The Facebook group (30.0%, 12/40) had an insignificantly lower relapse rate than the control group (42.6%, 23/54) at 2-month (OR 0.58, 95% CI 0.24-1.37) and 6-month (52.5%, 13/40 vs 61.1%, 33/54; OR 0.70, 95% CI 0.31-1.61) follow-ups. The WhatsApp social groups had more moderators’ posts (median 60, IQR 25 vs median 32, IQR 7; P=.05) and participants’ posts (median 35, IQR 50 vs median 6, IQR 9; P=.07) than their Facebook counterparts, but the difference was insignificant. Conclusions The intervention via the WhatsApp social group was effective in reducing

  10. Cognitive Behavioral Principles within Group Mentoring: A Randomized Pilot Study

    ERIC Educational Resources Information Center

    Jent, Jason F.; Niec, Larissa N.

    2009-01-01

    This study evaluated the effectiveness of a group mentoring program that included components of empirically supported mentoring and cognitive behavioral techniques for children served at a community mental health center. Eighty-six 8- to 12-year-old children were randomly assigned to either group mentoring or a wait-list control group. Group…

  11. A Comparison of Web-based and Small-Group Palliative and End-of-Life Care Curricula: A Quasi-Randomized Controlled Study at One Institution

    PubMed Central

    Day, Frank C.; Srinivasan, Malathi; Der-Martirosian, Claudia; Griffin, Erin; Hoffman, Jerome R.; Wilkes, Michael S.

    2014-01-01

    Purpose Few studies have compared the effect of web-based eLearning versus small-group learning on medical student outcomes. Palliative and end-of-life (PEOL) education is ideal for this comparison, given uneven access to PEOL experts and content nationally. Method In 2010, the authors enrolled all third-year medical students at the University of California, Davis School of Medicine into a quasi-randomized controlled trial of web-based interactive education (eDoctoring) compared to small-group education (Doctoring) on PEOL clinical content over two months. All students participated in three 3-hour PEOL sessions with similar content. Outcomes included a 24-item PEOL-specific self-efficacy scale with three domains (diagnosis/treatment [Cronbach’s alpha = 0.92, CI: 0.91–0.93], communication/prognosis [alpha = 0.95; CI: 0.93–0.96], and social impact/self-care [alpha = 0.91; CI: 0.88–0.92]); eight knowledge items; ten curricular advantage/disadvantages, and curricular satisfaction (both students and faculty). Results Students were randomly assigned to web-based eDoctoring (n = 48) or small-group Doctoring (n = 71) curricula. Self-efficacy and knowledge improved equivalently between groups: e.g., prognosis self-efficacy, 19%; knowledge, 10–42%. Student and faculty ratings of the web-based eDoctoring curriculum and the small group Doctoring curriculum were equivalent for most goals, and overall satisfaction was equivalent for each, with a trend towards decreased eDoctoring student satisfaction. Conclusions Findings showed equivalent gains in self-efficacy and knowledge between students participating in a web-based PEOL curriculum, in comparison to students learning similar content in a small-group format. Web-based curricula can standardize content presentation when local teaching expertise is limited, but may lead to decreased user satisfaction. PMID:25539518

  12. Effectiveness of a School-Based Group Psychotherapy Program for War-Exposed Adolescents: A Randomized Control Trial

    ERIC Educational Resources Information Center

    Layne, Christopher M.; Saltzman, William R.; Poppleton, Landon; Burlingame, Gary M.; Pasalic, Alma; Durakovic, Elvira; Music, Mirjana; Campara, Nihada; Dapo, Nermin; Arslanagic, Berina; Steinberg, Alan M.; Pynoos, Robert S.

    2008-01-01

    The study assesses the comparative efficacy of a classroom-based psycho-education and skills intervention and a school-based trauma- and grief-focused group treatment of a three-tiered mental health program for adolescents exposed to severe war-trauma, traumatic bereavement, and postwar adversity. The two-tier approach, combined with…

  13. Internet-Delivered Targeted Group Intervention for Body Dissatisfaction and Disordered Eating in Adolescent Girls: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Heinicke, Brooke E.; Paxton, Susan J.; McLean, Sian A.; Wertheim, Eleanor H.

    2007-01-01

    This study evaluated a targeted intervention designed to alleviate body image and eating problems in adolescent girls that was delivered over the internet so as to increase access to the program. The program consisted of six, 90-minute weekly small group, synchronous on-line sessions and was facilitated by a therapist and manual. Participants were…

  14. Making healthy eating and physical activity policy practice: process evaluation of a group randomized controlled intervention in afterschool programs.

    PubMed

    Weaver, R Glenn; Beets, Michael W; Hutto, Brent; Saunders, Ruth P; Moore, Justin B; Turner-McGrievy, Gabrielle; Huberty, Jennifer L; Ward, Dianne S; Pate, Russell R; Beighle, Aaron; Freedman, Darcy

    2015-12-01

    This study describes the link between level of implementation and outcomes from an intervention to increase afterschool programs' (ASPs) achievement of healthy eating and physical activity (HE-PA) Standards. Ten intervention ASPs implemented the Strategies-To-Enhance-Practice (STEPs), a multi-component, adaptive intervention framework identifying factors essential to meeting HE-PA Standards, while 10 control ASPs continued routine practice. All programs, intervention and control, were assigned a STEPs for HE-PA index score based on implementation. Mixed-effects linear regressions showed high implementation ASPs had the greatest percentage of boys and girls achieving 30 min of moderate-to-vigorous physical activity (47.3 and 29.3%), followed by low implementation ASPs (41.3 and 25.0%), and control ASPs (34.8 and 18.5%). For healthy eating, high/low implementation programs served fruits and vegetables an equivalent number of days, but more days than control programs (74.0 and 79.1% of days versus 14.2%). A similar pattern emerged for the percent of days sugar-sweetened foods and beverages were served, with high and low implementation programs serving sugar-sweetened foods (8.0 and 8.4% of days versus 52.2%), and beverages (8.7 and 2.9% of days versus 34.7%) equivalently, but less often than control programs. Differences in characteristics and implementation of STEPs for HE-PA between high/low implementers were also identified. PMID:26590240

  15. The Efficacy and Safety of Wenxin Keli in Patients with Frequent Premature Ventricular Contractions: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial

    PubMed Central

    Hua, Wei; Gao, Run-Lin; Zhao, Bu-Chang; Wang, Jing; Chen, Xu-Hua; Cai, Chi; Zhang, Shu

    2015-01-01

    Background: Premature ventricular contractions (PVCs) are common in the general population, and frequent PVCs may result in the poor quality of life or even the damage of cardiac function. We examined the efficacy and safety of a traditional Chinese medicine Wenxin Keli for the treatment of frequent PVCs among a relatively large Chinese cohort. Methods: We performed a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. A total of 1200 eligible participants were randomly assigned in a ratio of 1:1 to receive Wenxin Keli or the placebo for 4 weeks. The primary and secondary endpoint was the change of PVC numbers and PVC-related symptoms after a 4-week treatment compared with baseline, respectively. In addition, vital signs, laboratory values, and electrocardiographic parameters were assessed in a safety analysis. Results: At the initial evaluation, no significant differences in the baseline characteristics were observed between the Wenxin Keli group and the placebo group. A smaller number of PVCs was observed after the 4-week treatment than at baseline, in both the Wenxin Keli group (5686 ± 5940 vs. 15,138 ± 7597 beats/d, P < 0.001) and the placebo group (10,592 ± 8009 vs. 14,529 ± 5929 beats/d, P < 0.001); moreover, the Wenxin Keli group demonstrated a significantli greater reduction in the frequency of PVCs than the placebo group (P < 0.001). In a full analysis set, patients in the Wenxin Keli group exhibited significantly higher total effective responses in the reduction of PVCs compared to those in the placebo group (83.8% vs. 43.5%, P < 0.001). The per-protocol analysis yielded similar results (83.0% vs. 39.3%, P < 0.001). Treatment with Wenxin Keli also demonstrated superior performance compared to the placebo with respect to PVC-related symptoms. No severe adverse effects attributable to Wenxin Keli were reported. Conclusions: Wenxin Keli treatment effectively reduced the overall number of PVCs and alleviated PVC

  16. Protocol and recruitment results from a randomized controlled trial comparing group phone-based versus newsletter interventions for weight loss maintenance among rural breast cancer survivors.

    PubMed

    Befort, Christie A; Klemp, Jennifer R; Fabian, Carol; Perri, Michael G; Sullivan, Debra K; Schmitz, Kathryn H; Diaz, Francisco J; Shireman, Theresa

    2014-03-01

    Obesity is a risk factor for breast cancer recurrence and death. Women who reside in rural areas have higher obesity prevalence and suffer from breast cancer treatment-related disparities compared to urban women. The objective of this 5-year randomized controlled trial is to compare methods for delivering extended care for weight loss maintenance among rural breast cancer survivors. Group phone-based counseling via conference calls addresses access barriers, is more cost-effective than individual phone counseling, and provides group support which may be ideal for rural breast cancer survivors who are more likely to have unmet support needs. Women (n=210) diagnosed with Stage 0 to III breast cancer in the past 10 years who are ≥ 3 months out from initial cancer treatments, have a BMI 27-45 kg/m(2), and have physician clearance were enrolled from multiple cancer centers. During Phase I (months 0 to 6), all women receive a behavioral weight loss intervention delivered through group phone sessions. Women who successfully lose 5% of weight enter Phase II (months 6 to 18) and are randomized to one of two extended care arms: continued group phone-based treatment or a mail-based newsletter. During Phase III, no contact is made (months 18 to 24). The primary outcome is weight loss maintenance from 6 to 18 months. Secondary outcomes include quality of life, serum biomarkers, and cost-effectiveness. This study will provide essential information on how to reach rural survivors in future efforts to establish weight loss support for breast cancer survivors as a standard of care. PMID:24486636

  17. Protocol and Recruitment Results from a Randomized Controlled Trial Comparing Group Phone-Based versus Newsletter Interventions for Weight Loss Maintenance among Rural Breast Cancer Survivors

    PubMed Central

    Befort, Christie A.; Klemp, Jennifer R.; Fabian, Carol; Perri, Michael G.; Sullivan, Debra K.; Schmitz, Kathryn H.; Diaz, Francisco J.; Shireman, Theresa

    2014-01-01

    Obesity is a risk factor for breast cancer recurrence and death. Women who reside in rural areas have higher obesity prevalence and suffer from breast cancer treatment-related disparities compared to urban women. The objective of this 5-year randomized controlled trial is to compare methods for delivering extended care for weight loss maintenance among rural breast cancer survivors. Group phone-based counseling via conference calls addresses access barriers, is more cost-effective than individual phone counseling, and provides group support which may be ideal for rural breast cancer survivors who are more likely to have unmet support needs. Women (n = 210) diagnosed with Stage 0 to III breast cancer in the past 10 years who are ≥ 3 months out from initial cancer treatments, have a BMI 27–45 kg/m2, and have physician clearance were enrolled from multiple cancer centers. During Phase I (months 0 to 6), all women receive a behavioral weight loss intervention delivered through group phone sessions. Women who successfully lose 5% of weight enter Phase II (months 6 to 18) and are randomized to one of two extended care arms: continued group phone-based treatment or a mail-based newsletter. During Phase III, no contact is made (months 18 to 24). The primary outcome is weight loss maintenance from 6 to 18 months. Secondary outcomes include quality of life, serum biomarkers, and cost-effectiveness. This study will provide essential information in how to reach rural survivors in future efforts to establish weight loss support for breast cancer survivors as a standard of care. PMID:24486636

  18. Efficacy of movement control exercises versus general exercises on recurrent sub-acute nonspecific low back pain in a sub-group of patients with movement control dysfunction. protocol of a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Practice guidelines recommend various types of exercise for chronic back pain but there have been few head-to-head comparisons of these interventions. General exercise seems to be an effective option for management of chronic low back pain (LBP) but very little is known about the management of a sub-acute LBP within sub-groups. Recent research has developed clinical tests to identify a subgroup of patients with chronic non-specific LBP who have movement control dysfunction (MD). Method/Design We are conducting a randomized controlled trial (RCT) to compare the effects of general exercise and specific movement control exercise (SMCE) on disability and function in patients with MD within recurrent sub-acute LBP. The main outcome measure is the Roland Morris Disability Questionnaire. Discussion European clinical guideline for management of chronic LBP recommends that more research is required to develop tools to improve the classification and identification of specific clinical sub-groups of chronic LBP patients. Good quality RCTs are then needed to determine the effectiveness of specific interventions aimed at these specific target groups. This RCT aims to test the hypothesis whether patients within a sub-group of MD benefit more through a specific individually tailored movement control exercise program than through general exercises. PMID:22494776

  19. CHILE: Outcomes of a group randomized controlled trial of an intervention to prevent obesity in preschool Hispanic and American Indian children

    PubMed Central

    Davis, Sally M.; Myers, Orrin B.; Cruz, Theresa H.; Morshed, Alexandra B.; Canaca, Glenda F.; Keane, Patricia C.; O'Donald, Elena R.

    2016-01-01

    Objective We examined the outcomes of the Child Health Initiative for Lifelong Eating and Exercise (CHILE) study, a group randomized controlled trial to design, implement, and test the efficacy of a trans-community intervention to prevent obesity in children enrolled in Head Start centers in rural American Indian and Hispanic communities in New Mexico. Methods CHILE was a 5-year evidence-based intervention that used a socioecological approach to improving dietary intake and increasing physical activity of 1898 children. The intervention included a classroom curriculum, teacher and food service training, family engagement, grocery store participation, and healthcare provider support. Height and weight measurements were obtained four times (fall of 2008, spring and fall of 2009, and spring of 2010), and body mass index (BMI) z-scores in the intervention and comparison groups were compared. Results At baseline, demographic characteristics in the comparison and intervention groups were similar, and 33% of all the children assessed were obese or overweight. At the end of the intervention, there was no significant difference between the two groups in BMI z-scores. Conclusions Obesity prevention research among Hispanic and AI preschool children in rural communities is challenging and complex. Although the CHILE intervention was implemented successfully, changes in overweight and obesity may take longer than 2 years to achieve. PMID:27222162

  20. The effect of group training on pregnancy-induced lumbopelvic pain: systematic review and meta-analysis of randomized control trials.

    PubMed

    Fisseha, Berihu; Mishra, Prakash Kumar

    2016-02-01

    Since there is lack of up to date consensus exists as to whether group training is effective in improving lumbopelvic pain (LPP) after pregnancy, a review of the recent evidences is needed. To determine the effect of group exercise training for the management of LPP among pregnant women compared with usual antenatal care. An electronic database search for relevant randomized control trials published in English from 2006 to 2015 was conducted. Articles with outcome measures of self-reported LPP, visual analogue scale and sick leave due to LPP after pregnancy were included. Quality of the included articles was rated using Physiotherapy Evidence Database (PEDro) scale and the pooled effect of self-reported LPP was obtained by Review Manager (RevMan 5) software. Significant effect of group training was detected over usual antenatal care or no treatment with P=0.0035 (95% confidence interval, -0.2348 to -0.0044). The results of this systematic review proposed that group training reduces LPP significantly better than routine antenatal care for pregnant women suffered from LPP. PMID:26933655

  1. A Randomized Controlled Trial to Decrease Job Burnout in First-Year Internal Medicine Residents Using a Facilitated Discussion Group Intervention.

    PubMed

    Ripp, Jonathan A; Fallar, Robert; Korenstein, Deborah

    2016-05-01

    Background Burnout is common in internal medicine (IM) trainees and is associated with depression and suboptimal patient care. Facilitated group discussion reduces burnout among practicing clinicians. Objective We hypothesized that this type of intervention would reduce incident burnout among first-year IM residents. Methods Between June 2013 and May 2014, participants from a convenience sample of 51 incoming IM residents were randomly assigned (in groups of 3) to the intervention or a control. Twice-monthly theme-based discussion sessions (18 total) led by expert facilitators were held for intervention groups. Surveys were administered at study onset and completion. Demographic and personal characteristics were collected. Burnout and burnout domains were the primary outcomes. Following convention, we defined burnout as a high emotional exhaustion or depersonalization score on the Maslach Burnout Inventory. Results All 51 eligible residents participated; 39 (76%) completed both surveys. Initial burnout prevalence (10 of 21 [48%] versus 7 of 17 [41%], P = .69), incidence of burnout at year end (9 of 11 [82%] versus 5 of 10 [50%], P = .18), and secondary outcomes were similar in intervention and control arms. More residents in the intervention group had high year-end depersonalization scores (18 of 21 [86%] versus 9 of 17 [53%], P = .04). Many intervention residents revealed that sessions did not truly free them from clinical or educational responsibilities. Conclusions A facilitated group discussion intervention did not decrease burnout in resident physicians. Future discussion-based interventions for reducing resident burnout should be voluntary and effectively free participants from clinical duties. PMID:27168899

  2. Safety evaluation of the consumption of high dose milk fat globule membrane in healthy adults: a double-blind, randomized controlled trial with parallel group design.

    PubMed

    Hari, Sayaka; Ochiai, Ryuji; Shioya, Yasushi; Katsuragi, Yoshihisa

    2015-01-01

    Consumption of milk fat globule membrane (MFGM) in combination with habitual exercise suppresses age-associated muscle loss. The effects of high dose MFGM, however, are not known. A double-blind, randomized controlled trial with parallel group design was conducted to evaluate the safety of consuming high dose MFGM tablets. The subjects were 32 healthy adult men and women. Subjects were given 5 times the recommended daily intake of the tablets containing 6.5 g of MFGM or whole milk powder for 4 weeks. Stomach discomfort and diarrhea were observed; however, these symptoms were transitory and slight and were not related to consumption of the test tablets. In addition, there were no clinically significant changes in anthropometric measurements or blood tests. Total degree of safety assessed by the physicians of all subjects was "safe." These findings suggest that consumption of the tablets containing 6.5 g MFGM for 4 weeks is safe for healthy adults. PMID:25704503

  3. Control theory for random systems

    NASA Technical Reports Server (NTRS)

    Bryson, A. E., Jr.

    1972-01-01

    A survey is presented of the current knowledge available for designing and predicting the effectiveness of controllers for dynamic systems which can be modeled by ordinary differential equations. A short discussion of feedback control is followed by a description of deterministic controller design and the concept of system state. The need for more realistic disturbance models led to the use of stochastic process concepts, in particular the Gauss-Markov process. A compensator controlled system, with random forcing functions, random errors in the measurements, and random initial conditions, is treated as constituting a Gauss-Markov random process; hence the mean-square behavior of the controlled system is readily predicted. As an example, a compensator is designed for a helicopter to maintain it in hover in a gusty wind over a point on the ground.

  4. Tretinoin Nanogel 0.025% Versus Conventional Gel 0.025% in Patients with Acne Vulgaris: A Randomized, Active Controlled, Multicentre, Parallel Group, Phase IV Clinical Trial

    PubMed Central

    Chandrashekhar, B S; Anitha, M.; Ruparelia, Mukesh; Vaidya, Pradyumna; Aamir, Riyaz; Shah, Sunil; Thilak, S; Aurangabadkar, Sanjeev; Pal, Sandeep; Saraswat, Abir

    2015-01-01

    Background: Conventional topical tretinoin formulation is often associated with local adverse events. Nanogel formulation of tretinoin has good physical stability and enables good penetration of tretinoin into the pilo-sebaceous glands. Aim: The present study was conducted to assess the efficacy and safety of a nanogel formulation of tretinoin as compared to its conventional gel formulation in the treatment of acne vulgaris of the face. Materials and Methods: This randomized, active controlled, multicentric, phase IV clinical trial evaluated the treatment of patients with acne vulgaris of the face by the two gel formulations locally applied once daily at night for 12 wk. Acne lesion counts (inflammatory, non-inflammatory & total) and severity grading were carried out on the monthly scheduled visits along with the tolerability assessments. Results: A total of 207 patients were randomized in the study. Reductions in the total (72.9% vs. 65.0%; p = 0.03) and inflammatory (78.1% vs. 66.9%; p = 0.02) acne lesions were reported to be significantly greater with the nanogel formulation as compared to the conventional gel formulation. Local adverse events were significantly less (p = 0.04) in the nanogel group (13.3%) as compared to the conventional gel group (24.7%). Dryness was the most common adverse event reported in both the treatment groups while peeling of skin, burning sensation and photosensitivity were reported in patients using the conventional gel only. Conclusion: In the treatment of acne vulgaris of the face, tretinoin nanogel formulation appears to be more effective and better tolerated than the conventional gel formulation. PMID:25738069

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

    PubMed

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

    2011-01-01

    PURPOSE. This study compares a traditional worksite-based health promotion program with an activated consumer program and a control program DESIGN. Group randomized controlled trial with 18-month intervention. SETTING. Two large Midwestern companies. SUBJECTS. Three hundred and twenty employees (51% response). INTERVENTION. The traditional health promotion intervention offered population-level campaigns on physical activity, nutrition, and stress management. The activated consumer intervention included population-level campaigns for evaluating health information, choosing a health benefits plan, and understanding the risks of not taking medications as prescribed. The personal development intervention (control group) offered information on hobbies. The interventions also offered individual-level coaching for high risk individuals in both active intervention groups. MEASURES. Health risk status, general health status, consumer activation, productivity, and the ability to evaluate health information. ANALYSIS. Multivariate analyses controlled for baseline differences among the study groups. RESULTS. At the population level, compared with baseline performance, the traditional health promotion intervention improved health risk status, consumer activation, and the ability to recognize reliable health websites. Compared with baseline performance, the activated consumer intervention improved consumer activation, productivity, and the ability to recognize reliable health websites. At the population level, however, only the activated consumer intervention improved any outcome more than the control group did; that outcome was consumer activation. At the individual level for high risk individuals, both traditional health coaching and activated consumer coaching positively affected health risk status and consumer activation. In addition, both coaching interventions improved participant ability to recognize a reliable health website. Consumer activation coaching also

  6. Feasibility and effectiveness of a combined individual and psychoeducational group intervention in psychiatric residential facilities: A controlled, non-randomized study.

    PubMed

    Magliano, Lorenza; Puviani, Marta; Rega, Sonia; Marchesini, Nadia; Rossetti, Marisa; Starace, Fabrizio

    2016-01-30

    This controlled, non-randomized study explored the feasibility of introducing a Combined Individual and Group Intervention (CIGI) for users with mental disorders in residential facilities, and tested whether users who received the CIGI had better functioning than users who received the Treatment-As-Usual (TAU), at two-year follow up. In the CIGI, a structured cognitivebehavioral approach called VADO (in English, Skills Assessment and Definition of Goals) was used to set specific goals with each user, while Falloon's psychoeducational treatment was applied with the users as a group. Thirty-one professionals attended a training course in CIGI, open to users' voluntary participation, and applied it for two years with all users living in 8 residential facilities of the Mental Health Department of Modena, Italy. In the same department, 5 other residential facilities providing TAU were used as controls. ANOVA for repeated measures showed a significant interaction effect between users' functioning at baseline and follow up assessments, and the intervention. In particular, change in global functioning was higher in the 55 CIGI users than in the 44 TAU users. These results suggest that CIGI can be successfully introduced in residential facilities and may be useful to improve functioning in users with severe mental disorders. PMID:26723137

  7. Teaching tobacco dependence treatment and counseling skills during medical school: rationale and design of the Medical Students helping patients Quit tobacco (MSQuit) group randomized controlled trial

    PubMed Central

    Hayes, Rashelle B.; Geller, Alan; Churchill, Linda; Jolicoeur, Denise; Murray, David M.; Shoben, Abigail; David, Sean P.; Adams, Michael; Okuyemi, Kola; Fauver, Randy; Gross, Robin; Leone, Frank; Xiao, Rui; Waugh, Jonathan; Crawford, Sybil; Ockene, Judith K.

    2014-01-01

    INTRODUCTION Physician-delivered tobacco treatment using the 5As is clinically recommended, yet its use has been limited. Lack of adequate training and confidence to provide tobacco treatment are cited as leading reasons for limited 5A use. Tobacco dependence treatment training while in medical school is recommended, but is minimally provided. The MSQuit trial (Medical Students helping patients Quit tobacco) aims to determine if a multi-modal and theoretically-guided tobacco educational intervention will improve tobacco dependence treatment skills (i.e. 5As) among medical students. METHODS/DESIGN 10 U.S. medical schools were pair-matched and randomized in a group-randomized controlled trial to evaluate whether a multi-modal educational (MME) intervention compared to traditional education (TE) will improve observed tobacco treatment skills. MME is primarily composed of TE approaches (i.e. didactics) plus a 1st year web-based course and preceptor-facilitated training during a 3rd year clerkship rotation. The primary outcome measure is an objective score on an Objective Structured Clinical Examination (OSCE) tobacco-counseling smoking case among 3rd year medical students from schools who implemented the MME or TE. DISCUSSION MSQuit is the first randomized to evaluate whether a tobacco treatment educational intervention implemented during medical school will improve medical students’ tobacco treatment skills. We hypothesize that the MME intervention will better prepare students in tobacco dependence treatment as measured by the OSCE. If a comprehensive tobacco treatment educational learning approach is effective, while also feasible and acceptable to implement, then medical schools may substantially influence skill development and use of the 5As among future physicians. PMID:24486635

  8. Making healthy eating and physical activity policy practice: the design and overview of a group randomized controlled trial in afterschool programs.

    PubMed

    Beets, Michael W; Glenn Weaver, R; Turner-McGrievy, Gabrielle; Huberty, Jennifer; Ward, Dianne S; Freedman, Darcy A; Saunders, Ruth; Pate, Russell R; Beighle, Aaron; Hutto, Brent; Moore, Justin B

    2014-07-01

    National and state organizations have developed policies calling upon afterschool programs (ASPs, 3-6 pm) to serve a fruit or vegetable (FV) each day for snack, while eliminating foods and beverages high in added-sugars, and to ensure children accumulate a minimum of 30 min/d of moderate-to-vigorous physical activity (MVPA). Few efficacious and cost-effective strategies exist to assist ASP providers in achieving these important public health goals. This paper reports on the design and conceptual framework of Making Healthy Eating and Physical Activity (HEPA) Policy Practice in ASPs, a 3-year group randomized controlled trial testing the effectiveness of strategies designed to improve snacks served and increase MVPA in children attending community-based ASPs. Twenty ASPs, serving over 1800 children (6-12 years) will be enrolled and match-paired based on enrollment size, average daily min/d MVPA, and days/week FV served, with ASPs randomized after baseline data collection to immediate intervention or a 1-year delayed group. The framework employed, STEPs (Strategies To Enhance Practice), focuses on intentional programming of HEPA in each ASPs' daily schedule, and includes a grocery store partnership to reduce price barriers to purchasing FV, professional development training to promote physical activity to develop core physical activity competencies, as well as ongoing technical support/assistance. Primary outcome measures include children's accelerometry-derived MVPA and time spend sedentary while attending an ASP, direct observation of staff HEPA promoting and inhibiting behaviors, types of snacks served, and child consumption of snacks, as well as, cost of snacks via receipts and detailed accounting of intervention delivery costs to estimate cost-effectiveness. PMID:24893225

  9. Making Healthy Eating and Physical Activity Policy Practice: The Design and Overview of a Group Randomized Controlled Trial in Afterschool Programs

    PubMed Central

    Beets, Michael W.; Weaver, R. Glenn; Turner-McGrievy, Gabrielle; Huberty, Jennifer; Ward, Dianne S.; Freedman, Darcy A.; Saunders, Ruth; Pate, Russell R.; Beighle, Aaron; Moore, Justin B.

    2014-01-01

    National and state organizations have developed policies calling upon afterschool programs (ASPs, 3-6pm) to serve a fruit or vegetable (FV) each day for snack, while eliminating foods and beverages high in added-sugars, and to ensure children accumulate a minimum of 30 min/d of moderate-to-vigorous physical activity (MVPA). Few efficacious and cost-effective strategies exist to assist ASP providers in achieving these important public health goals. This paper reports on the design and conceptual framework of Making Healthy Eating and Physical Activity (HEPA) Policy Practice in ASPs, a 3-year group randomized controlled trial testing the effectiveness of strategies designed to improve snacks served and increase MVPA in children attending community-based ASPs. Twenty ASPs, serving over 1,800 children (6-12yrs) will be enrolled and match-paired based on enrollment size, average daily min/d MVPA, and days/week FV served, with ASPs randomized after baseline data collection to immediate intervention or a 1-year delayed group. The framework employed, STEPs (Strategies To Enhance Practice), focuses on intentional programming of HEPA in each ASPs’ daily schedule, and includes a grocery store partnership to reduce price barriers to purchasing FV, professional development training to promote physical activity to develop core physical activity competencies, as well as ongoing technical support/assistance. Primary outcome measures include children’s accelerometry-derived MVPA and time spend sedentary while attending an ASP, direct observation of staff HEPA promoting and inhibiting behaviors, types of snacks served, and child consumption of snacks, as well as, cost of snacks via receipts and detailed accounting of intervention delivery costs to estimate cost-effectiveness. PMID:24893225

  10. Comparing Standard Versus Prosocial Internet Support Groups for Patients With Breast Cancer: A Randomized Controlled Trial of the Helper Therapy Principle

    PubMed Central

    Lepore, Stephen J.; Buzaglo, Joanne S.; Lieberman, Morton A.; Golant, Mitch; Greener, Judith R.; Davey, Adam

    2014-01-01

    Purpose Internet support group (ISG) members benefit from receiving social support and, according to the helper therapy principle, by providing support to others. To test the mental health benefits of providing support to others, this trial compared the efficacy of a standard ISG (S-ISG) and an enhanced prosocial ISG (P-ISG). Methods A two-armed randomized controlled trial with 1-month pretest and post-test assessments was conducted with women (N = 184) diagnosed in the past 36 months with nonmetastatic breast cancer who reported elevated anxiety or depression. Women were randomly assigned to either the S-ISG or P-ISG condition. Both conditions included six professionally facilitated live chat sessions (90-minute weekly sessions) and access to an asynchronous discussion board; P-ISG also included structured opportunities to help and encourage others. Results Relative to the S-ISG, participants in the P-ISG condition exhibited more supportive behaviors (emotional, informational, and companionate support), posted more messages that were other-focused and fewer that were self-focused, and expressed less negative emotion (P < .05). Relative to the S-ISG, participants in the P-ISG condition had a higher level of depression and anxiety symptoms after the intervention (P < .05). Conclusion Despite the successful manipulation of supportive behaviors, the P-ISG did not produce better mental health outcomes in distressed survivors of breast cancer relative to an S-ISG. The prosocial manipulation may have inadvertently constrained women from expressing their needs openly, and thus, they may not have had their needs fully met in the group. Helping others may not be beneficial as a treatment for distressed survivors of breast cancer. PMID:25403218

  11. Analytic Methods for Individually Randomized Group Treatment Trials and Group-Randomized Trials When Subjects Belong to Multiple Groups

    PubMed Central

    Andridge, Rebecca. R.; Shoben, Abigail B.; Muller, Keith E.; Murray, David M.

    2014-01-01

    Participants in trials may be randomized either individually or in groups, and may receive their treatment either entirely individually, entirely in groups, or partially individually and partially in groups. This paper concerns cases in which participants receive their treatment either entirely or partially in groups, regardless of how they were randomized. Participants in Group-Randomized Trials (GRTs) are randomized in groups and participants in Individually Randomized Group Treatment (IRGT) trials are individually randomized, but participants in both types of trials receive part or all of their treatment in groups or through common change agents. Participants who receive part or all of their treatment in a group are expected to have positively correlated outcome measurements. This paper addresses a situation that occurs in GRTs and IRGT trials – participants receive treatment through more than one group. As motivation, we consider trials in The Childhood Obesity Prevention and Treatment Research Consortium (COPTR), in which each child participant receives treatment in at least two groups. In simulation studies we considered several possible analytic approaches over a variety of possible group structures. A mixed model with random effects for both groups provided the only consistent protection against inflated type I error rates and did so at the cost of only moderate loss of power when intraclass correlations were not large. We recommend constraining variance estimates to be positive and using the Kenward-Roger adjustment for degrees of freedom; this combination provided additional power but maintained type I error rates at the nominal level. PMID:24399701

  12. Randomized trial of group cognitive behavioral therapy compared with a pain education control for low-literacy rural people with chronic pain.

    PubMed

    Thorn, Beverly E; Day, Melissa A; Burns, John; Kuhajda, Melissa C; Gaskins, Susan W; Sweeney, Kelly; McConley, Regina; Ward, L Charles; Cabbil, Chalanda

    2011-12-01

    Chronic pain is a common and costly experience. Cognitive behavioral therapies (CBT) are efficacious for an array of chronic pain conditions. However, the literature is based primarily on urban (white) samples. It is unknown whether CBT works in low-socioeconomic status (SES) minority and nonminority groups. To address this question, we conducted a randomized controlled trial within a low-SES, rural chronic pain population. Specifically, we examined the feasibility, tolerability, acceptability, and efficacy of group CBT compared with a group education intervention (EDU). We hypothesized that although both interventions would elicit short- and long-term improvement across pain-related outcomes, the cognitively-focused CBT protocol would uniquely influence pain catastrophizing. Mixed design analyses of variance were conducted on the sample of eligible participants who did not commence treatment (N=26), the intention-to-treat sample (ITT; N=83), and the completer sample (N=61). Factors associated with treatment completion were examined. Results indicated significantly more drop-outs occurred in CBT. ITT analyses showed that participants in both conditions reported significant improvement across pain-related outcomes, and a nonsignificant trend was found for depressed mood to improve more in CBT than EDU. Results of the completer analyses produced a similar pattern of findings; however, CBT produced greater gains on cognitive and affect variables than EDU. Treatment gains were maintained at 6-month follow-up (N=54). Clinical significance of the findings and the number of treatment responders is reported. Overall, these findings indicate that CBT and EDU are viable treatment options in low-SES minority and nonminority groups. Further research should target disseminating and sustaining psychosocial treatment options within underserved populations. PMID:21920668

  13. Matching with Multiple Control Groups with Adjustment for Group Differences

    ERIC Educational Resources Information Center

    Stuart, Elizabeth A.; Rubin, Donald B.

    2008-01-01

    When estimating causal effects from observational data, it is desirable to approximate a randomized experiment as closely as possible. This goal can often be achieved by choosing a subsample from the original control group that matches the treatment group on the distribution of the observed covariates. However, sometimes the original control group…

  14. Intake of black-vinegar-mash-garlic enhances salivary release of secretory IgA: A randomized, double-blind, placebo-controlled, parallel-group study

    PubMed Central

    NAKASONE, YASUSHI; SATO, NORIMASA; AZUMA, TAKAYUKI; HASUMI, KEIJI

    2016-01-01

    Several previous studies have provided evidence that suggests the beneficial effects of garlic and black vinegar on human health, including benefits to immune function. The preliminary study indicated that the intake of black-vinegar-mash-garlic-containing food, created from aged garlic pickled in the mash of black vinegar, enhanced the release of secretory immunoglobulin A (sIgA) in the saliva. The aim of the present study was to evaluate the effect of the food in a randomized, double-blind, placebo-controlled, parallel-group trial. The trial was conducted in subjects aged between 30 and 60 years whose rate of salivary sIgA release was moderately low. Subjects consumed 2.49 g of placebo or black-vinegar-mash-garlic-containing food (active food) daily for 8 weeks. The data obtained with 54 eligible subjects (n=28 and 26 for placebo and active, respectively) were analyzed for efficacy. The rates of salivary sIgA release in the active food group (35.9±84.6 and 47.9±123.4 µg/min at weeks 4 and 8 of intake; changes from pretrial value) were higher compared to the respective rates in the placebo food group (−12.3±72.1 and −3.2±85.9 µg/min, P=0.028 and 0.082, respectively). These findings indicate that intake of black-vinegar-mash-garlic-containing food enhanced the intraoral immune response. There was no adverse event associated with the intake of active food. PMID:27347407

  15. Tailored exercise program reduces symptoms of upper limb work-related musculoskeletal disorders in a group of metalworkers: A randomized controlled trial.

    PubMed

    Rasotto, Chiara; Bergamin, Marco; Simonetti, Alberto; Maso, Stefano; Bartolucci, Giovanni B; Ermolao, Andrea; Zaccaria, Marco

    2015-02-01

    Work-related musculoskeletal disorders (WRMDs) are a leading cause of work-related disability and loss of productivity in the developed countries; these disorders may concur with the indirect costs of an illness or injury included losses of potential output. Literature on workplace physical activity program provided a mixed but positive impact on health and important worksite outcomes. Therefore, programs of physical activity organized and performed in the workplace could reveal as essential tool to reduce musculoskeletal symptoms. This investigation aimed to assess the effectiveness of a tailored physical activity program, performed in a work-environment, to reduce the symptoms in upper extremities and neck with the novelty in personalizing the approach applied to the exercise protocol, basing on pain and disability levels, to reduce the onset and symptoms in upper extremity and neck WRMDs increasing upper-limb strength and flexibility. 68 metalworkers were recruited, 34 were randomly allocated to an intervention group (IG), while the other 34 to a control group. Primary outcomes concerned pain symptoms measured with visual analog scales while disability was measured by DASH (Disability of the Arm, Shoulder and Hand), and NPDS-I (Neck Pain and Disability Scale) questionnaires. Grip strength, upper-limb mobility, neck and shoulder range of motion were also assessed. After the 9-month intervention, IG reduced pain symptoms on neck, shoulders, elbows and on wrists. Grip strength and upper-limb mobility improved as well as scores on questionnaires. This protocol suggests that performing a tailored physical activity program is beneficial to reduce pain and disability on upper-limb WRMDs. PMID:25027479

  16. A failure to confirm the effectiveness of a brief group psychoeducational program for mothers of children with high-functioning pervasive developmental disorders: a randomized controlled pilot trial

    PubMed Central

    Suzuki, Masako; Yamada, Atsurou; Watanabe, Norio; Akechi, Tatsuo; Katsuki, Fujika; Nishiyama, Takeshi; Imaeda, Masayuki; Miyachi, Taishi; Otaki, Kazuo; Mitsuda, Yumiko; Ota, Akino; Furukawa, Toshi A

    2014-01-01

    Objective The purpose of this study was to examine the effectiveness of group psychoeducation to relieve the psychological distress of mothers of children with high-functioning pervasive developmental disorders (HFPDD) and to improve the behaviors of the children. Methods Seventy-two mothers of preschool outpatients with HFPDD were randomly assigned to a four-session brief group psychoeducational program (GP). The sessions were held every second week in addition to the usual treatment (GP + treatment as usual [TAU] group), or to a TAU-alone group. The primary outcome was self-reported symptoms of maternal mental health as assessed using the 28-item General Health Questionnaire (GHQ-28) at 21 weeks post-randomization (week 21). The GHQ-28 at the end of the intervention (week 7), Aberrant Behavior Checklist (ABC) for the behavior of the children, the Zarit Burden Interview (ZBI), and the Medical Outcomes Study 36-item Short Form Health Survey (SF-36) were carried out at weeks 7 and 21. We tested the group effects with the interaction between the intervention and the evaluation points. Results The GHQ-28 score at week 21 was significantly higher in the GP + TAU group as compared to that in the TAU-alone group, indicating a greater improvement in the TAU-alone group. There was no evidence that GP + TAU led to a greater improvement of maternal mental health than TAU-alone at week 7. Similarly, no evidence was obtained to indicate that GP + TAU led to a reduction in the ABC or ZBI scores by week 7 or 21. The adjusted scores for the RF (role emotional) and MH (mental health) subscales of the SF-36 at week 21 were also significantly lower in the GP + TAU group, indicating a similar tendency to that of the change of the GHQ-28 score at week 21. Conclusion The psychoeducational program did not alleviate maternal distress, aberrant behaviors of the children, or caregiver burden. PMID:25061301

  17. Cognitive Behavioral Principles Within Group Mentoring: A Randomized Pilot Study

    PubMed Central

    JENT, JASON F.; NIEC, LARISSA N.

    2010-01-01

    This study evaluated the effectiveness of a group mentoring program that included components of empirically supported mentoring and cognitive behavioral techniques for children served at a community mental health center. Eighty-six 8- to 12-year-old children were randomly assigned to either group mentoring or a wait-list control group. Group mentoring significantly increased children’s reported social problem-solving skills and decreased parent-reported child externalizing and internalizing behavior problems after controlling for other concurrent mental health services. Attrition from the group mentoring program was notably low (7%) for children. The integration of a cognitive behavioral group mentoring program into children’s existing community mental health services may result in additional reductions in externalizing and internalizing behavior problems. PMID:20582243

  18. Internet-Based Self-Help with Therapist Feedback and in Vivo Group Exposure for Social Phobia: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Andersson, Gerhard; Carlbring, Per; Holmstrom, Annelie; Sparthan, Elisabeth; Furmark, Tomas; Nilsson-Ihrfelt, Elisabeth; Buhrman, Monica; Ekselius, Lisa

    2006-01-01

    Sixty-four individuals with social phobia (social anxiety disorder) were assigned to a multimodal cognitive-behavioral treatment package or to a waiting list control group. Treatment consisted of a 9-week, Internet-delivered, self-help program that was combined with 2 group exposure sessions in real life and minimal therapist contact via e-mail.…

  19. ADULTS: A RANDOMIZED CONTROLLED CLINICAL TRIAL

    PubMed Central

    Shah, Krupa N.; Majeed, Zahraa; Yoruk, Yilmaz B.; Yang, Hongmei; Hilton, Tiffany N.; McMahon, James M.; Hall, William J.; Walck, Donna; Luque, Amneris E.; Ryan, Richard M.

    2016-01-01

    Objective HIV-infected older adults (HOA) are at risk of functional decline. Interventions promoting physical activity that can attenuate functional decline and are easily translated into the HOA community are of high priority. We conducted a randomized, controlled clinical trial to evaluate whether a physical activity counseling intervention based on self-determination theory (SDT) improves physical function, autonomous motivation, depression and the quality of life (QOL) in HOA. Methods A total of 67 community-dwelling HOA with mild-to-moderate functional limitations were randomized to one of two groups: a physical activity counseling group or the usual care control group. We used SDT to guide the development of the experimental intervention. Outcome measures that were collected at baseline and final study visits included a battery of physical function tests, levels of physical activity, autonomous motivation, depression, and QOL. Results The study participants were similar in their demographic and clinical characteristics in both the treatment and control groups. Overall physical performance, gait speed, measures of endurance and strength, and levels of physical activity improved in the treatment group compared to the control group (p<0.05). Measures of autonomous regulation such as identified regulation, and measures of depression and QOL improved significantly in the treatment group compared to the control group (p<0.05). Across the groups, improvement in intrinsic regulation and QOL correlated with an improvement in physical function (p<0.05). Conclusion Our findings suggest that a physical activity counseling program grounded in SDT can improve physical function, autonomous motivation, depression, and QOL in HOA with functional limitations. PMID:26867045

  20. Effectiveness of Peer Group and Conventional Method (Dentist) of Oral Health Education Programme Among 12-15 year Old School Children - A Randomized Controlled Trial

    PubMed Central

    Jha, Abhishek; Raju, Rekha; Bashyam, Mamtha

    2016-01-01

    Introduction Oral Health Education (OHE) in schools is routinely delivered by the dentist. Another approach which can be cost-effective, easily accessible and equally effective is the trained group of peer students. Aim The objective of the present study was to assess and compare the effectiveness of peer–led and conventional method (dentist-led), OHE on oral health status, oral health knowledge, attitude and practices among 12-15 year old government school children in Bengaluru South Zone-I at baseline, 3 months and 6 months. Materials and Methods The study population comprised of 450 subjects, 150 each in peer, dentist and control group. At baseline, a pre-tested 14 item questionnaire was used to assess the existing oral health knowledge, attitude and oral hygiene practices of the subjects. Clinical examination included recording of plaque index and gingival index, by a pre-calibrated examiner. OHE was provided by the peer group and dentist (using power-point presentation, chalk and talk presentation, using charts, posters, booklets and tooth brushing demonstration models). Data was analyzed using Kruskal Wallis and Chi-square test. Results Both the peer-led and dentist-led OHE intervention were effective in improving oral health knowledge, attitude, oral hygiene practices and oral health status at three and six months when compared to control group. The adolescents in the peer-led group, however, exhibited statistically better oral health behavior than their counterparts in the dentist-led group and control group. Conclusion The two educator-led strategies (peer group and dentist) had a modest effect on the outcome variables included in the study, the results provide some evidence to show that the peer-led strategy may provide a feasible and almost equally effective alternative to the traditional dentist led strategy of oral health education. PMID:27437345

  1. Affectionate Writing Reduces Total Cholesterol: Two Randomized, Controlled Trials

    ERIC Educational Resources Information Center

    Floyd, Kory; Mikkelson, Alan C.; Hesse, Colin; Pauley, Perry M.

    2007-01-01

    In two 5-week trials, healthy college students were randomly assigned either to experimental or control groups. Participants in the experimental groups wrote about their affection for significant friends, relatives, and/or romantic partners for 20 minutes on three separate occasions; on the same schedule, those in the control groups wrote about…

  2. A group-randomized controlled trial for health promotion in Girl Scouts: Healthier Troops in a SNAP (Scouting Nutrition & Activity Program)

    PubMed Central

    2010-01-01

    Background Girl Scouting may offer a viable channel for health promotion and obesity prevention programs. This study evaluated the effectiveness of an intervention program delivered through Girl Scout Junior troops that was designed to foster healthful troop meeting environments and increase obesity prevention behaviors at home. Methods Seven Girl Scout troops were randomized to intervention (n = 3, with 34 girls) or standard-care control (n = 4, with 42 girls) conditions. Girls ranged in age from 9 to 13 years (mean 10.5 years). Intervention troop leaders were trained to implement policies promoting physical activity (PA) and healthful eating opportunities at troop meetings, and to implement a curriculum promoting obesity-prevention behaviors at home. The primary outcome variable was child body mass index (BMI) z-score. Secondary outcomes included accelerometer-assessed PA levels in troop meetings, direct observations of snack offerings, time spent in physically active meeting content, and leader encouragement of PA and healthful eating. Results The intervention was delivered with good fidelity, and intervention troops provided greater opportunities for healthful eating and PA (x2 = 210.8, p < .001), relative to control troops. In troop meetings, intervention troop leaders promoted PA (x2 = 23.46, p < .001) and healthful eating (x2 = 18.14, p < .001) more frequently, and discouraged healthful eating and PA less frequently (x2 = 9.63, p = .002) compared to control troop leaders. Most effects of the intervention on individual-level variables of girls and parents were not significantly different from the control condition, including the primary outcome of child BMI z-score (F1, 5 = 0.42, p = .544), parent BMI (F1, 5 = 1.58, p = .264), and related behavioral variables. The notable exception was for objectively assessed troop PA, wherein girls in intervention troops accumulated significantly less sedentary (x2 = 6.3, p = .011), significantly more moderate (x2 = 8.2, p

  3. Dolasetron for the prevention of postoperative nausea and vomiting following outpatient surgery with general anaesthesia: a randomized, placebo-controlled study. The Dolasetron PONV Prevention Study Group.

    PubMed

    Philip, B K; Pearman, M H; Kovac, A L; Chelly, J E; Wetchler, B V; McKenzie, R; Monk, T G; Dershwitz, M; Mingus, M; Sung, Y F; Hahne, W F; Brown, R A

    2000-01-01

    In a multicentre, randomized, double-blind, placebo-controlled dose-ranging study, 1030 patients undergoing outpatient surgery with general anaesthesia received i.v. dolasetron mesylate (12.5, 25, 50, or 100 mg) or placebo. The principal outcome measure was the proportion of patients who were free of emesis or rescue medication for the 24-h period after the study drug was given; the subsidiary outcome measure was survival time without rescue medication. Effects on nausea were quantified using a visual analogue scale. Compared with placebo, a complete response was significantly higher when all four dolasetron doses were combined (49% vs. 58%, P =0.025). In females, dolasetron, 12.5-mg, dolasetron provided maximum clinical benefit (effectiveness compared with adverse events), with no additional benefit in complete response rates or nausea visual analogue scale scores at higher doses. No significant differences were observed in complete response for any dolasetron dose in males compared with placebo. The majority of adverse events reported were mild or moderate. Dolasetron provided well-tolerated, safe, and effective prophylaxis for post-operative nausea and vomiting with maximum effectiveness observed at a dose of 12.5 mg. PMID:10758440

  4. Can the Onset of Type 2 Diabetes Be Delayed by a Group-Based Lifestyle Intervention in Women with Prediabetes following Gestational Diabetes Mellitus (GDM)? Findings from a Randomized Control Mixed Methods Trial

    PubMed Central

    O'Dea, Angela; Tierney, Marie; McGuire, Brian E.; Newell, John; Glynn, Liam G.; Gibson, Irene; Noctor, Eoin; Danyliv, Andrii; Connolly, Susan B.; Dunne, Fidelma P.

    2015-01-01

    Objective. To evaluate a 12-week group-based lifestyle intervention programme for women with prediabetes following gestational diabetes (GDM). Design. A two-group, mixed methods randomized controlled trial in which 50 women with a history of GDM and abnormal glucose tolerance postpartum were randomly assigned to intervention (n = 24) or wait control (n = 26) and postintervention qualitative interviews with participants. Main Outcome Measures. Modifiable biochemical, anthropometric, behavioural, and psychosocial risk factors associated with the development of type 2 diabetes. The primary outcome variable was the change in fasting plasma glucose (FPG) from study entry to one-year follow-up. Results. At one-year follow-up, the intervention group showed significant improvements over the wait control group on stress, diet self-efficacy, and quality of life. There was no evidence of an effect of the intervention on measures of biochemistry or anthropometry; the effect on one health behaviour, diet adherence, was close to significance. Conclusions. Prevention programmes must tackle the barriers to participation faced by this population; home-based interventions should be investigated. Strategies for promoting long-term health self-management need to be developed and tested. PMID:26347894

  5. Randomized clinical trial of a customized electronic alert requiring an affirmative response compared to a control group receiving a commercial passive CPOE alert: NSAID–warfarin co-prescribing as a test case

    PubMed Central

    Schinnar, Rita; Bilker, Warren; Hennessy, Sean; Leonard, Charles E; Pifer, Eric

    2010-01-01

    Background Studies that have looked at the effectiveness of computerized decision support systems to prevent drug–drug interactions have reported modest results because of low response by the providers to the automated alerts. Objective To evaluate, within an inpatient computerized physician order entry (CPOE) system, the incremental effectiveness of an alert that required a response from the provider, intended as a stronger intervention to prevent concurrent orders of warfarin and non-steroidal anti-inflammatory drugs (NSAIDs). Design Randomized clinical trial of 1963 clinicians assigned to either an intervention group receiving a customized electronic alert requiring affirmative response or a control group receiving a commercially available passive alert as part of the CPOE. The study duration was 2 August 2006 to 15 December 2007. Measurements Alert adherence was compared between study groups. Results The proportion of desired ordering responses (ie, not reordering the alert-triggering drug after firing) was lower in the intervention group (114/464 (25%) customized alerts issued) than in the control group (154/560 (28%) passive alerts firing). The adjusted OR of inappropriate ordering was 1.22 (95% CI 0.69 to 2.16). Conclusion A customized CPOE alert that required a provider response had no effect in reducing concomitant prescribing of NSAIDs and warfarin beyond that of the commercially available passive alert received by the control group. New CPOE alerts cannot be assumed to be effective in improving prescribing, and need evaluation. PMID:20595308

  6. Quality Control in Small Groups

    NASA Astrophysics Data System (ADS)

    Lemmens, L. F.

    2008-11-01

    The smallness of some groups in a set up to control the quality of a service using questionnaires limits the size of the samples, this limitation has several consequences. Indeed the common approach used for relatively large groups, based on the central limit theorem and the law of large numbers, cannot be used anymore to construct estimators for the parameters of the model. Using an inverse probability will lift these restrictions. A questionnaire is a collection of items. In an item the respondent indicates on a Likert scale his or her agreement with a statement. Dimensions are a set of items dealing with one aspect of the service. In a questionnaire several dimensions are addressed but usually the items are presented in a random sequence. The model for an item is hierarchical with following components: a multivariate hypergeometric model takes the sampling in a finite population into account, the multinomial serves as a prior for the sampling and the Dirichlet-distribution serves as a prior for the multinomials. The composition of dimensions allows to use the posterior for one of the items as a prior for another item of that dimension and so on. After analysis of several questionnaires using this model, the reliability of the responses from some respondents turned out to be a key-problem, in the sense the responses can be classified into at least two classes and a decision rule had to be developed to neglect some of them. The influence of rejecting some answers, on the confidence for the most plausible statement can be estimated. This leads often to the result that there is only minimal evidence for the most probable statement.

  7. The MyPEEPS randomized controlled trial: A pilot of preliminary efficacy, feasibility, and acceptability of a group-level, HIV risk reduction intervention for young men who have sex with men

    PubMed Central

    Hidalgo, Marco A.; Kuhns, Lisa M.; Hotton, Anna L.; Johnson, Amy K.; Mustanski, Brian; Garofalo, Robert

    2015-01-01

    An exigent need exists for HIV prevention intervention research targeting young men who have sex with men (MSM) – a group of young adults that, despite composing the highest and most racially disproportionate rates of HIV incidence, has been least often the focus of behavioral intervention research. This pilot study tested a group-based HIV primary prevention intervention for young MSM to evaluate its initial efficacy, feasibility, and acceptability. Participants were randomized (N=101; aged 16-20 years) to one of two group-level, HIV and STI education programs: controls participated in a non-interactive, lecture-based program while intervention participants took part in a highly interactive program tailored to young MSM aged 16-20. Sexual risk and social cognitive outcomes were assessed at baseline, and 6- and 12 weeks post-intervention. Over the entire follow-up period, intervention participants were less likely than controls to engage in any sexual behavior while under the influence of substances (p<0.05), and also observed in this group was a decreasing trend of unprotected anal sex while under the influence of substances (p=.08). Follow-up differences between groups on social cognitive outcomes favored the intervention group, though these differences were non-significant. Acceptability ratings were modest. A 6-session behavioral intervention tailored to young MSM, aged 16-20, is feasible, acceptable, and demonstrates evidence of preliminary efficacy in reducing sexual risk, specifically sexual risk while under the influence of substances. PMID:25135064

  8. Blood Pressure Response to Zofenopril or Irbesartan Each Combined with Hydrochlorothiazide in High-Risk Hypertensives Uncontrolled by Monotherapy: A Randomized, Double-Blind, Controlled, Parallel Group, Noninferiority Trial

    PubMed Central

    Malacco, Ettore; Omboni, Stefano; Parati, Gianfranco

    2015-01-01

    In this randomized, double-blind, controlled, parallel group study (ZENITH), 434 essential hypertensives with additional cardiovascular risk factors, uncontrolled by a previous monotherapy, were treated for 18 weeks with zofenopril 30 or 60 mg plus hydrochlorothiazide (HCTZ) 12.5 mg or irbesartan 150 or 300 mg plus HCTZ. Rate of office blood pressure (BP) response (zofenopril: 68% versus irbesartan: 70%; p = 0.778) and 24-hour BP response (zofenopril: 85% versus irbesartan: 84%; p = 0.781) was similar between the two treatment groups. Cardiac and renal damage was equally reduced by both treatments, whereas the rate of carotid plaque regression was significantly larger with zofenopril. In conclusion, uncontrolled monotherapy treated hypertensives effectively respond to a combination of zofenopril or irbesartan plus a thiazide diuretic, in terms of either BP response or target organ damage progression. PMID:26347187

  9. Intraclass Correlations for Planning Group Randomized Experiments in Rural Education

    ERIC Educational Resources Information Center

    Hedges, Larry V.; Hedberg, E. C.

    2007-01-01

    Experiments that assign intact groups (usually schools) to treatment conditions are increasingly common in educational research. The design of group randomized experiments requires knowledge of the intraclass correlation structure to compute statistical power and to determine the sample sizes required to achieve adequate power. The intraclass…

  10. Efficacy of Diosmectite (Smecta)® in the Treatment of Acute Watery Diarrhoea in Adults: A Multicentre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study

    PubMed Central

    Khediri, Faouzi; Mrad, Abdennebi Ilhem; Azzouz, Moussadek; Doughi, Hedi; Najjar, Taoufik; Mathiex-Fortunet, Hélène; Garnier, Philippe; Cortot, Antoine

    2011-01-01

    Background. Although diosmectite has demonstrated efficacy in the treatment of acute watery diarrhoea in children, its efficacy in adults still needs to be assessed. The objective of this study was therefore to assess the efficacy of diosmectite on the time to recovery in adults with acute diarrhoea. Methods. A total of 346 adults with at least three watery stools per day over a period of less than 48 hours were prospectively randomized to diosmectite (6 g tid) or placebo during four days. The primary endpoint was time to diarrhoea recovery. Results. In the intention-to-treat population, median time to recovery was 53.8 hours (range [3.7–167.3]) with diosmectite (n = 166) versus 69.0 hours [2.2–165.2] with placebo, (n = 163; P = .029), which corresponds to a difference of 15.2 hours. Diosmectite was well tolerated. Conclusion. Diosmectite at 6 g tid was well tolerated and reduced the time to recovery of acute watery diarrhoea episode in a clinically relevant manner. PMID:21760777

  11. Direct versus Indirect and Individual versus Group Modes of Language Therapy for Children with Primary Language Impairment: Principal Outcomes from a Randomized Controlled Trial and Economic Evaluation

    ERIC Educational Resources Information Center

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

    2009-01-01

    Background: Many school-age children with language impairments are enrolled in mainstream schools and receive indirect language therapy, but there have been, to the authors' knowledge, no previous controlled studies comparing the outcomes and costs of direct and indirect intervention delivered by qualified therapists and therapy assistants, and…

  12. Control systems on Lie groups.

    NASA Technical Reports Server (NTRS)

    Jurdjevic, V.; Sussmann, H. J.

    1972-01-01

    The controllability properties of systems which are described by an evolution equation in a Lie group are studied. The revelant Lie algebras induced by a right invariant system are singled out, and the basic properties of attainable sets are derived. The homogeneous case and the general case are studied, and results are interpreted in terms of controllability. Five examples are given.

  13. Cognitively Engaging Chronic Physical Activity, But Not Aerobic Exercise, Affects Executive Functions in Primary School Children: A Group-Randomized Controlled Trial.

    PubMed

    Schmidt, Mirko; Jäger, Katja; Egger, Fabienne; Roebers, Claudia M; Conzelmann, Achim

    2015-12-01

    Although the positive effects of different kinds of physical activity (PA) on cognitive functioning have already been demonstrated in a variety of studies, the role of cognitive engagement in promoting children's executive functions is still unclear. The aim of the current study was therefore to investigate the effects of two qualitatively different chronic PA interventions on executive functions in primary school children. Children (N = 181) aged between 10 and 12 years were assigned to either a 6-week physical education program with a high level of physical exertion and high cognitive engagement (team games), a physical education program with high physical exertion but low cognitive engagement (aerobic exercise), or to a physical education program with both low physical exertion and low cognitive engagement (control condition). Executive functions (updating, inhibition, shifting) and aerobic fitness (multistage 20-m shuttle run test) were measured before and after the respective condition. Results revealed that both interventions (team games and aerobic exercise) have a positive impact on children's aerobic fitness (4-5% increase in estimated VO2max). Importantly, an improvement in shifting performance was found only in the team games and not in the aerobic exercise or control condition. Thus, the inclusion of cognitive engagement in PA seems to be the most promising type of chronic intervention to enhance executive functions in children, providing further evidence for the importance of the qualitative aspects of PA. PMID:26866766

  14. The effect of addition of low dose fentanyl to epidural bupivacaine (0.5%) in patients undergoing elective caesarean section: A randomized, parallel group, double blind, placebo controlled study

    PubMed Central

    Parate, LH; Manjrekar, SP; Anandaswamy, TC; Manjunath, B

    2015-01-01

    Background: Opioids have synergistic action with local anesthetics which may alter characteristics of epidural block. Giving opioids to mother before delivery of baby is still fully not accepted with some fearing risk of neonatal depression. Aims: Our primary aim was to evaluate the analgesic effect of addition of 50 μg fentanyl to epidural 0.5% bupivacaine in patients undergoing elective caesarean section using visual analog scale. The secondary aim was to assess onset of analgesia, volume of drug required to achieve T6 level, grade and duration of motor block and Apgar score. Materials and Methods: In this prospective, randomized, double blind, placebo controlled study 64 patients scheduled for elective caesarean section under epidural anesthesia were randomly divided into two groups of 32 each. The fentanyl group received 1ml of 50 μg fentanyl and the saline group received 1ml of normal saline mixed with 10ml of 0.5% bupivacaine for epidural anesthesia. VAS score, time to achieve T6 level, dose of bupivacaine, intraoperative analgesic consumption and duration of analgesia, grade and duration of motor block and any adverse maternal and neonatal effects were noted. Statistical Analysis: Data was analyzed using Students t test, chi-square test and Mann-Whitney U-test. The values of P < 0.05 were considered statistically significant. Results: Fentanyl improved the VAS score significantly (1.6 ± 1.32) compared to the saline group (3.77 ± 1.0, P < 0.0001). It also reduced the intraoperaitve analgesic supplementation compared to the saline group. (P = 0.031). The postoperative duration of analgesia was prolonged in the fentanyl group (275.80 ± 13.61 min) compared to the saline group (191.47 ± 12.16 min, P < 0.0001). The other characteristics of epidural block were unaltered. Conclusion: Addition of 50 μg fentanyl to epidural 0.5% bupivacaine significantly reduces the VAS score. It also reduces intra-operative analgesia supplementation and prolongs the duration

  15. A community-based, culturally relevant intervention to promote healthy eating and physical activity among middle-aged African American women in rural Alabama: Findings from a group randomized controlled trial

    PubMed Central

    Scarinci, Isabel C.; Moore, Artisha; Wynn, Theresa; Cherrington, Andrea; Fouad, Mona; Li, Yufeng

    2015-01-01

    Objective We examined the efficacy of a community-based, culturally relevant intervention to promote healthy eating and physical activity among African American (AA) women between the ages of 45–65 years, residing in rural Alabama. Methods We conducted a group randomized controlled trial with counties as the unit of randomization that evaluated two interventions based on health priorities identified by the community: (1) promotion of healthy eating and physical activity; and (2) promotion of breast and cervical cancer screening. A total of 6 counties with 565 participants were enrolled in the study between November 2009 and October 2011. Results The overall retention rate at 24-month follow-up was 54.7%. Higher retention rate was observed in the “healthy lifestyle” arm (63.1%) as compared to the “screening” arm (45.3%). Participants in the “healthy lifestyle” arm showed significant positive changes compared to the “screening” arm at 12-month follow-up with regard to decrease in fried food consumption and an increase in both fruit/vegetable intake and physical activity. At 24-month follow-up, these positive changes were maintained with healthy eating behaviors, but not engagement in physical activity. Conclusions A culturally relevant intervention, developed in collaboration with the target audience, can improve (and maintain) healthy eating among AA women living in rural areas. PMID:25152504

  16. First steps: study protocol for a randomized controlled trial of the effectiveness of the Group Family Nurse Partnership (gFNP) program compared to routine care in improving outcomes for high-risk mothers and their children and preventing abuse

    PubMed Central

    2013-01-01

    Background Evidence from the USA suggests that the home-based Family Nurse Partnership program (FNP), extending from early pregnancy until infants are 24 months, can reduce the risk of child abuse and neglect throughout childhood. FNP is now widely available in the UK. A new variant, Group Family Nurse Partnership (gFNP) offers similar content but in a group context and for a shorter time, until infants are 12 months old. Each group comprises 8 to 12 women with similar expected delivery dates and their partners. Its implementation has been established but there is no evidence of its effectiveness. Methods/Design The study comprises a multi-site randomized controlled trial designed to identify the benefits of gFNP compared to standard care. Participants (not eligible for FNP) must be either aged < 20 years at their last menstrual period (LMP) with one or more previous live births, or aged 20 to 24 at LMP with low educational qualifications and no previous live births. ‘Low educational qualifications’ is defined as not having both Maths and English Language GCSE at grade C or higher or, if they have both, no more than four in total at grade C or higher. Exclusions are: under 20 years and previously received home-based FNP and, in either age group, severe psychotic mental illness or not able to communicate in English. Consenting women are randomly allocated (minimized by site and maternal age group) when between 10 and 16 weeks pregnant to either to the 44 session gFNP program or to standard care after the collection of baseline information. Researchers are blind to group assignment. The primary outcomes at 12 months are child abuse potential based on the revised Adult-Adolescent Parenting Inventory and parent/infant interaction coded using the CARE Index based on a video-taped interaction. Secondary outcomes are maternal depression, parenting stress, health related quality of life, social support, and use of services. Discussion This is the first study of the

  17. Building Kindergartners’ Number Sense: A Randomized Controlled Study

    PubMed Central

    Jordan, Nancy C.; Glutting, Joseph; Dyson, Nancy; Hassinger-Das, Brenna; Irwin, Casey

    2015-01-01

    Math achievement in elementary school is mediated by performance and growth in number sense during kindergarten. The aim of the present study was to test the effectiveness of a targeted small group number sense intervention for high-risk kindergartners from low-income communities. Children were randomly assigned to one of three groups (n = 44 in each group): a number sense intervention group, a language intervention group, or a business as usual control group. Accounting for initial skill level in mathematical knowledge, children who received the number sense intervention performed better than controls at immediate post test, with meaningful effects on measures of number competencies and general math achievement. Many of the effects held eight weeks after the intervention was completed, suggesting that children internalized what they had learned. There were no differences between the language and control groups on any math-related measures. PMID:25866417

  18. Benefit from prolonged dose-intensive chemotherapy for infants with malignant brain tumors is restricted to patients with ependymoma: a report of the Pediatric Oncology Group randomized controlled trial 9233/34

    PubMed Central

    Strother, Douglas R.; Lafay-Cousin, Lucie; Boyett, James M.; Burger, Peter; Aronin, Patricia; Constine, Louis; Duffner, Patricia; Kocak, Mehmet; Kun, Larry E.; Horowitz, Marc E.; Gajjar, Amar

    2014-01-01

    Background The randomized controlled Pediatric Oncology Group study 9233 tested the hypothesis that dose-intensive (DI) chemotherapy would improve event-free survival (EFS) for children <3 years of age with newly diagnosed malignant brain tumors. Methods Of 328 enrolled eligible patients, diagnoses were medulloblastoma (n = 112), ependymoma (n = 82), supratentorial primitive neuroectodermal tumor (sPNET, n = 38) and other malignant brain tumors (n = 96), and were randomized to 72 weeks of standard dose chemotherapy (Regimen A, n = 162) or DI chemotherapy (Regimen B, n = 166). Radiation therapy (RT) was recommended for patients with evidence of disease at completion of chemotherapy or who relapsed within 6 months of chemotherapy completion. Results Distributions of EFS for Regimens A and B were not significantly different (P = 0.32) with 2- and 10-year rates of 22.8% ± 3.3% and 15.4% ± 3.7%, and 27.1% ± 3.4% and 20.8% ± 3.8%, respectively. Thus, the study hypothesis was rejected. While distributions of EFS and OS were not significantly different between Regimens A and B for patients with medulloblastoma and sPNET, DI chemotherapy resulted in significantly improved EFS distribution (P = .0011) (2-year EFS rates of 42.1% vs. 19.6% with SD chemotherapy), but not OS distribution, for patients with centrally confirmed ependymoma. The degree of surgical resection affected EFS, OS or both for most tumor groups. Approximately 20%, 40% and 20% of patients with medulloblastoma, ependymoma treated with DI chemotherapy, and sPNET, respectively appear to have been cured without RT. Of 11 toxic deaths on study, 10 occurred on the DI chemotherapy arm. Conclusions Prolonged dose-intensive chemotherapy given to infants with malignant brain tumors resulted in increased EFS only for patients with ependymoma. PMID:24335695

  19. Use of group-randomized trials in pet population research.

    PubMed

    Lord, L K; Wittum, T E; Scarlett, J M

    2007-12-14

    Communities invest considerable resources to address the animal welfare and public health concerns resulting from unwanted pet animals. Traditionally, research in this area has enumerated the pet-owning population, described pet population dynamics in individual communities, and estimated national euthanasia figures. Recent research has investigated the human-animal bond and explored the community implications of managed feral cat colonies. These reports have utilized traditional epidemiologic study designs to generate observational data to describe populations and measure associations. However, rigorous scientific evaluations of potential interventions at the group level have been lacking. Group-randomized trials have been used extensively in public health research to evaluate interventions that change a population's behavior, not just the behavior of selected individuals. We briefly describe the strengths and limitations of group-randomized trials as they are used to evaluate interventions that promote social and behavioral changes in the human public health field. We extend these examples to suggest the appropriate application of group-randomized trials for pet population dynamics research. PMID:17707934

  20. A double-blind, randomized, placebo-controlled, parallel-group study of THC/CBD oromucosal spray in combination with the existing treatment regimen, in the relief of central neuropathic pain in patients with multiple sclerosis.

    PubMed

    Langford, R M; Mares, J; Novotna, A; Vachova, M; Novakova, I; Notcutt, W; Ratcliffe, S

    2013-04-01

    Central neuropathic pain (CNP) occurs in many multiple sclerosis (MS) patients. The provision of adequate pain relief to these patients can very difficult. Here we report the first phase III placebo-controlled study of the efficacy of the endocannabinoid system modulator delta-9-tetrahydrocannabinol (THC)/cannabidiol (CBD) oromucosal spray (USAN name, nabiximols; Sativex, GW Pharmaceuticals, Salisbury, Wiltshire, UK), to alleviate CNP. Patients who had failed to gain adequate analgesia from existing medication were treated with THC/CBD spray or placebo as an add-on treatment, in a double-blind manner, for 14 weeks to investigate the efficacy of the medication in MS-induced neuropathic pain. This parallel-group phase of the study was then followed by an 18-week randomized-withdrawal study (14-week open-label treatment period plus a double-blind 4-week randomized-withdrawal phase) to investigate time to treatment failure and show maintenance of efficacy. A total of 339 patients were randomized to phase A (167 received THC/CBD spray and 172 received placebo). Of those who completed phase A, 58 entered the randomized-withdrawal phase. The primary endpoint of responder analysis at the 30 % level at week 14 of phase A of the study was not met, with 50 % of patients on THC/CBD spray classed as responders at the 30 % level compared to 45 % of patients on placebo (p = 0.234). However, an interim analysis at week 10 showed a statistically significant treatment difference in favor of THC/CBD spray at this time point (p = 0.046). During the randomized-withdrawal phase, the primary endpoint of time to treatment failure was statistically significant in favor of THC/CBD spray, with 57 % of patients receiving placebo failing treatment versus 24 % of patients from the THC/CBD spray group (p = 0.04). The mean change from baseline in Pain Numerical Rating Scale (NRS) (p = 0.028) and sleep quality NRS (p = 0.015) scores, both secondary endpoints in phase B, were also statistically

  1. Pedometer Use in University Freshmen: A Randomized Controlled Pilot Study

    ERIC Educational Resources Information Center

    LeCheminant, James D.; Smith, John D.; Covington, N. Kay; Hardin-Renschen, Tracie; Heden, Tim

    2011-01-01

    Objectives: To describe activity patterns associated with a pedometer intervention in university freshmen and compare the intervention participants to controls for several health outcomes. Methods: Forty-six university freshmen were randomized to a group that wore a pedometer across the academic year with a goal of 10,000 steps/day or to a control…

  2. Rationale and design of the HepZero study: a prospective, multicenter, international, open, randomized, controlled clinical study with parallel groups comparing heparin-free dialysis with heparin-coated dialysis membrane (Evodial) versus standard care: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Anticoagulation for chronic dialysis patients with contraindications to heparin administration is challenging. Current guidelines state that in patients with increased bleeding risks, strategies that can induce systemic anticoagulation should be avoided. Heparin-free dialysis using intermittent saline flushes is widely adopted as the method of choice for patients at risk of bleeding, although on-line blood predilution may also be used. A new dialyzer, Evodial (Gambro, Lund, Sweden), is grafted with unfractionated heparin during the manufacturing process and may allow safe and efficient heparin-free hemodialysis sessions. In the present trial, Evodial was compared to standard care with either saline flushes or blood predilution. Methods The HepZero study is the first international (seven countries), multicenter (10 centers), randomized, controlled, open-label, non-inferiority (and if applicable subsequently, superiority) trial with two parallel groups, comprising 252 end-stage renal disease patients treated by maintenance hemodialysis for at least 3 months and requiring heparin-free dialysis treatments. Patients will be treated during a maximum of three heparin-free dialysis treatments with either saline flushes or blood predilution (control group), or Evodial. The first heparin-free dialysis treatment will be considered successful when there is: no complete occlusion of air traps or dialyzer rendering dialysis impossible; no additional saline flushes to prevent clotting; no change of dialyzer or blood lines because of clotting; and no premature termination (early rinse-back) because of clotting. The primary objectives of the study are to determine the effectiveness of the Evodial dialyzer, compared with standard care in terms of successful treatments during the first heparin-free dialysis. If the non-inferiority of Evodial is demonstrated then the superiority of Evodial over standard care will be tested. The HepZero study results may have major clinical

  3. Networked Dynamic Systems: Identification, Controllability, and Randomness

    NASA Astrophysics Data System (ADS)

    Nabi-Abdolyousefi, Marzieh

    The presented dissertation aims to develop a graph-centric framework for the analysis and synthesis of networked dynamic systems (NDS) consisting of multiple dynamic units that interact via an interconnection topology. We examined three categories of network problems, namely, identification, controllability, and randomness. In network identification, as a subclass of inverse problems, we made an explicit relation between the input-output behavior of an NDS and the underlying interacting network. In network controllability, we provided structural and algebraic insights into features of the network that enable external signal(s) to control the state of the nodes in the network for certain classes of interconnections, namely, path, circulant, and Cartesian networks. We also examined the relation between network controllability and the symmetry structure of the graph. Motivated by the analysis results for the controllability and observability of deterministic networks, a natural question is whether randomness in the network layer or in the layer of inputs and outputs generically leads to favorable system theoretic properties. In this direction, we examined system theoretic properties of random networks including controllability, observability, and performance of optimal feedback controllers and estimators. We explored some of the ramifications of such an analysis framework in opinion dynamics over social networks and sensor networks in estimating the real-time position of a Seaglider from experimental data.

  4. Recruiting Participants for Randomized Controlled Trials

    ERIC Educational Resources Information Center

    Gallagher, H. Alix; Roschelle, Jeremy; Feng, Mingyu

    2014-01-01

    The objective of this study was to look across strategies used in a wide range of studies to build a framework for researchers to use in conceptualizing the recruitment process. This paper harvests lessons learned across 19 randomized controlled trials in K-12 school settings conducted by a leading research organization to identify strategies that…

  5. Reporting Randomized Controlled Trials in Education

    ERIC Educational Resources Information Center

    Mayo-Wilson, Evan; Grant, Sean; Montgomery, Paul

    2014-01-01

    Randomized controlled trials (RCTs) are increasingly used to evaluate programs and interventions in order to inform education policy and practice. High quality reports of these RCTs are needed for interested readers to understand the rigor of the study, the interventions tested, and the context in which the evaluation took place (Mayo-Wilson et…

  6. Nonperturbative dynamical decoupling with random control.

    PubMed

    Jing, Jun; Bishop, C Allen; Wu, Lian-Ao

    2014-01-01

    Parametric fluctuations or stochastic signals are introduced into the rectangular pulse sequence to investigate the feasibility of random dynamical decoupling. In a large parameter region, we find that the out-of-order control pulses work as well as the regular pulses for dynamical decoupling and dissipation suppression. Calculations and analysis are enabled by and based on a nonperturbative dynamical decoupling approach allowed by an exact quantum-state-diffusion equation. When the average frequency and duration of the pulse sequence take proper values, the random control sequence is robust, fault-tolerant, and insensitive to pulse strength deviations and interpulse temporal separation in the quasi-periodic sequence. This relaxes the operational requirements placed on quantum control devices to a great deal. PMID:25169735

  7. “Everybody Brush!”: Protocol for a Parallel-Group Randomized Controlled Trial of a Family-Focused Primary Prevention Program With Distribution of Oral Hygiene Products and Education to Increase Frequency of Toothbrushing

    PubMed Central

    2015-01-01

    Background Twice daily toothbrushing with fluoridated toothpaste is the most widely advocated preventive strategy for dental caries (tooth decay) and is recommended by professional dental associations. Not all parents, children, or adolescents follow this recommendation. This protocol describes the methods for the implementation and evaluation of a quality improvement health promotion program. Objective The objective of the study is to show a theory-informed, evidence-based program to improve twice daily toothbrushing and oral health-related quality of life that may reduce dental caries, dental treatment need, and costs. Methods The design is a parallel-group, pragmatic randomized controlled trial. Families of Medicaid-insured children and adolescents within a large dental care organization in central Oregon will participate in the trial (n=21,743). Families will be assigned to one of three groups: a test intervention, an active control, or a passive control condition. The intervention aims to address barriers and support for twice-daily toothbrushing. Families in the test condition will receive toothpaste and toothbrushes by mail for all family members every three months. In addition, they will receive education and social support to encourage toothbrushing via postcards, recorded telephone messages, and an optional participant-initiated telephone helpline. Families in the active control condition will receive the kit of supplies by mail, but no additional instructional information or telephone support. Families assigned to the passive control will be on a waiting list. The primary outcomes are restorative dental care received and, only for children younger than 36 months old at baseline, the frequency of twice-daily toothbrushing. Data will be collected through dental claims records and, for children younger than 36 months old at baseline, parent interviews and clinical exams. Results Enrollment of participants and baseline interviews have been completed. Final

  8. Thermal Control Working Group report

    NASA Technical Reports Server (NTRS)

    Haslett, Robert; Mahefkey, E. Thomas

    1986-01-01

    The Thermal Control Working Group limited its evaluation to issues associated with Earth orbiting and planetary spacecraft with power levels up to 50 kW. It was concluded that the space station technology is a necessary precursor but does not meet S/C 2000 needs (life, high heat flux, long term cryogenics, and survivability). Additional basic and applied research are required (fluid/materials compatibility and two phase system modeling). Scaling, the key issue, must define accelerated life test criteria. The two phase systems require 0g to 1 g correlation. Additional ground test beds are required and combined space environment tests of materials.

  9. Random partitions and asymptotic theory of symmetric groups, Hecke algebras and finite Chevalley groups

    NASA Astrophysics Data System (ADS)

    Méliot, Pierre-Loïc

    2010-12-01

    In this thesis, we investigate the asymptotics of random partitions chosen according to probability measures coming from the representation theory of the symmetric groups S_n and of the finite Chevalley groups GL(n,F_q) and Sp(2n,F_q). More precisely, we prove laws of large numbers and central limit theorems for the q-Plancherel measures of type A and B, the Schur-Weyl measures and the Gelfand measures. Using the RSK algorithm, it also gives results on longest increasing subsequences in random words. We develop a technique of moments (and cumulants) for random partitions, thereby using the polynomial functions on Young diagrams in the sense of Kerov and Olshanski. The algebra of polynomial functions, or observables of Young diagrams is isomorphic to the algebra of partial permutations; in the last part of the thesis, we try to generalize this beautiful construction.

  10. The Efficacy of Parent-Child Interaction Therapy with Chinese Families: Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leung, Cynthia; Tsang, Sandra; Sin, Tammy C. S.; Choi, Siu-yan

    2015-01-01

    Objective: This study aimed to examine the efficacy of the Parent-Child Interaction Therapy (PCIT) in Hong Kong Chinese families, using randomized controlled trial design. Methods: The participants included 111 Hong Kong Chinese parents with children aged 2--7 years old, who were randomized into the intervention group (n = 54) and control group (n…

  11. A Novel Religious/Spiritual Group Psychotherapy Reduces Depressive Symptoms in a Randomized Clinical Trial.

    PubMed

    Chida, Yoichi; Schrempft, Stephanie; Steptoe, Andrew

    2016-10-01

    This randomized controlled trial aimed to examine the effect of the Happy Science doctrine-based group psychotherapy on depressive symptoms in 118 Japanese mental disorder outpatients. The treatment group (n = 58) took part in five 90-min sessions at one-week intervals, while the control group (n = 60) received standard care including medication. Depressive symptoms were assessed before the intervention, 5 weeks after the intervention, and at 3-month follow-up. Compared to the control group, the treatment group showed a significant reduction in depressive symptoms both at post-intervention and at 3-month follow-up. In conclusion, this group psychotherapy might be of benefit in treating depressive symptoms. PMID:26320001

  12. Balneotherapy in fibromyalgia: a single blind randomized controlled clinical study.

    PubMed

    Ozkurt, Seçil; Dönmez, Arif; Zeki Karagülle, M; Uzunoğlu, Emel; Turan, Mustafa; Erdoğan, Nergis

    2012-07-01

    We aimed to evaluate the effectiveness of balneotherapy in fibromyalgia management. Fifty women with fibromyalgia under pharmacological treatment were randomly assigned to either the balneotherapy (25) or the control (25) group. Four patients from the balneotherapy group and one patient from the control group left the study after randomization. The patients in the balneotherapy group (21) had 2 thermomineral water baths daily for 2 weeks in Tuzla Spa Center. The patients in the control group (24) continued to have their medical treatment and routine daily life. An investigator who was blinded to the study arms assessed the patients. All patients were assessed four times; at the beginning of the study, at the end of the 2nd week, the 1st month, and the 3rd month after balneotherapy. Outcome measures of the study were pain intensity, Fibromyalgia Impact Questionnaire (FIQ), Beck Depression Inventory (BDI), patient's global assessment, investigator's global assessment, SF-36 scores, and tender point count. Balneotherapy was found to be superior at the end of the cure period in terms of pain intensity, FIQ, Beck Depression Inventory, patient's global assessment, investigator's global assessment scores, and tender point count as compared to the control group. The superiority of balneotherapy lasted up to the end of the 3rd month, except for the Beck Depression Inventory score and the investigator's global assessment score. Significant improvements were observed in PF, GH, and MH subscales of SF-36 during the study period in the balneotherapy group; however, no such improvement was observed in the control group. Balneotherapy was superior only in VT subscale at the end of therapy and at the end of the third month after the therapy as compared to the controls. It was concluded that balneotherapy provides beneficial effects in patients with fibromyalgia. PMID:21461716

  13. A randomized controlled trial of qigong for fibromyalgia

    PubMed Central

    2012-01-01

    Introduction Fibromyalgia is difficult to treat and requires the use of multiple approaches. This study is a randomized controlled trial of qigong compared with a wait-list control group in fibromyalgia. Methods One hundred participants were randomly assigned to immediate or delayed practice groups, with the delayed group receiving training at the end of the control period. Qigong training (level 1 Chaoyi Fanhuan Qigong, CFQ), given over three half-days, was followed by weekly review/practice sessions for eight weeks; participants were also asked to practice at home for 45 to 60 minutes per day for this interval. Outcomes were pain, impact, sleep, physical function and mental function, and these were recorded at baseline, eight weeks, four months and six months. Immediate and delayed practice groups were analyzed individually compared to the control group, and as a combination group. Results In both the immediate and delayed treatment groups, CFQ demonstrated significant improvements in pain, impact, sleep, physical function and mental function when compared to the wait-list/usual care control group at eight weeks, with benefits extending beyond this time. Analysis of combined data indicated significant changes for all measures at all times for six months, with only one exception. Post-hoc analysis based on self-reported practice times indicated greater benefit with the per protocol group compared to minimal practice. Conclusions This study demonstrates that CFQ, a particular form of qigong, provides long-term benefits in several core domains in fibromyalgia. CFQ may be a useful adjuvant self-care treatment for fibromyalgia. Trial registration clinicaltrials.gov NCT00938834. PMID:22863206

  14. Sample controllability of impulsive differential systems with random coefficients

    NASA Astrophysics Data System (ADS)

    Zhang, Shuorui; Sun, Jitao

    2016-07-01

    In this paper, we investigate the controllability of impulsive differential systems with random coefficients. Impulsive differential systems with random coefficients are a different stochastic model from stochastic differential equations. Sufficient conditions of sample controllability for impulsive differential systems with random coefficients are obtained by using random Sadovskii's fixed-point theorem. Finally, an example is given to illustrate our results.

  15. Control with a random access protocol and packet dropouts

    NASA Astrophysics Data System (ADS)

    Wang, Liyuan; Guo, Ge

    2016-08-01

    This paper investigates networked control systems whose actuators communicate with the controller via a limited number of unreliable channels. The access to the channels is decided by a so-called group random access protocol, which is modelled as a binary Markov sequence. Data packet dropouts in the channels are modelled as independent Bernoulli processes. For such systems, a systematic characterisation for controller synthesis is established and stated in terms of the transition probabilities of the Markov protocol and the packet dropout probabilities. The results are illustrated via a numerical example.

  16. Rationale and study protocol for the supporting children’s outcomes using rewards, exercise and skills (SCORES) group randomized controlled trial: A physical activity and fundamental movement skills intervention for primary schools in low-income communities

    PubMed Central

    2012-01-01

    Background Many Australian children are insufficiently active to accrue health benefits and physical activity (PA) levels are consistently lower among youth of low socio-economic position. PA levels decline dramatically during adolescence and evidence suggests that competency in a range of fundamental movement skills (FMS) may serve as a protective factor against this trend. Methods/design The Supporting Children’s Outcomes Using Rewards Exercise and Skills (SCORES) intervention is a multi-component PA and FMS intervention for primary schools in low-income communities, which will be evaluated using a group randomized controlled trial. The socio-ecological model provided a framework for the 12-month intervention, which includes the following components: teacher professional learning, student leadership workshops (including leadership accreditation and rewards, e.g., stickers, water bottles), PA policy review, PA equipment packs, parental engagement via newsletters, FMS homework and a parent evening, and community partnerships with local sporting organizations. Outcomes will be assessed at baseline, 6- and 12-months. The primary outcomes are PA (accelerometers), FMS (Test of Gross Motor Development II) and cardiorespiratory fitness (multi-stage fitness test). Secondary outcomes include body mass index [using weight (kg)/height (m2)], perceived competence, physical self-esteem, and resilience. Individual and environmental mediators of behavior change (e.g. social support and enjoyment) will also be assessed. The System for Observing Fitness Instruction Time will be used to assess the impact of the intervention on PA within physical education lessons. Statistical analyses will follow intention-to-treat principles and hypothesized mediators of PA behavior change will be explored. Discussion SCORES is an innovative primary school-based PA and FMS intervention designed to support students attending schools in low-income communities to be more skilled and active. The

  17. Strength and Agility Training in Adolescents with Down Syndrome: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Lin, Hsiu-Ching; Wuang, Yee-Pay

    2012-01-01

    The purpose of this study was to investigate the effects of a proposed strength and agility training program of adolescents with Down syndrome. Ninety-two adolescents were recruited and evenly randomized to two intervention groups (exercise group vs. control group). The mean age for the exercise and the control group was 10.6 plus or minus 3.2 and…

  18. Using baseline data to design a group randomized trial.

    PubMed

    Hughes, James P

    2005-07-15

    Group randomized trials (GRT) are often designed with relatively little preliminary data available to estimate key parameters. In this paper, however, the opposite situation is considered-very good baseline data are available on the primary outcome of interest. These data can then be used to inform key design and analysis decisions such as (i) should the trial be designed as an unmatched or pair-matched study, or stratified in some other fashion; (ii) is analysis of "change from baseline" preferable to using end-of-study data alone; and (iii) what power might be expected by pursuing these various strategies. The results are applied to a GRT for sexually transmitted diseases prevention in Peru. PMID:15779091

  19. Postoperative pain relief following hysterectomy: A randomized controlled trial

    PubMed Central

    Raghvendra, K. P.; Thapa, Deepak; Mitra, Sukanya; Ahuja, Vanita; Gombar, Satinder; Huria, Anju

    2016-01-01

    Background: Women experience moderate to severe postoperative pain following total abdominal hysterectomy (TAH). The transversus abdominis plane (TAP) block is a new modality for providing postoperative pain relief in these patients. Materials and Methods: The present study was a single center, prospective randomized trial. After the Institutional Ethics Committee approval and informed consent, patients were randomized to either epidural group: Epidural block placement + general anesthesia (GA) or TAP group: Single shot TAP block + GA. Patients in both the groups received standard general anesthetic technique and intravenous tramadol patient-controlled analgesia in the postoperative period. Patients were monitored for tramadol consumption, visual analog scale (VAS) both at rest and on coughing, hemodynamics, and side effects at 0, 2, 4, 6, 8, 12, and 24 h postoperatively. Results: The total consumption of tramadol in 24 h was greater in TAP group as compared to epidural group (68.8 [25.5] vs. 5.3 [11.6] mg, P < 0.001). The VAS scores at rest and on coughing were higher in TAP group as compared to the epidural group at 6, 8, 12, and 24 h postoperatively (P < 0.05). None of the patients in either group had any adverse effects. Conclusion: Epidural analgesia provided greater tramadol-sparing effect with superior analgesia postoperatively as compared to TAP block in patients up to 24 h following TAH. PMID:27499592

  20. The penumbra of randomized control trials

    PubMed Central

    Nanivadekar, Arun S.

    2013-01-01

    Pre-occupation with randomized control trials as the basis of evidence-based medicine has increasingly shadowed other study designs over the last half a century. These include surveys, case-control studies, and case-cohort studies. They have the potential to overcome several ethical and cost constraints, but depend on the embedding of research in routine practice, emphasis on relevant but limited, accurate, and complete data, harnessing of information technology for this purpose, and epidemiological and statistical literacy among clinicians. Only then will it be possible to nurture and network research-oriented practices by therapeutic areas. Given these, the alternative study designs can pave the way to regulatory reforms that will ultimately benefit the discoverers, approvers and users of health-care tools. PMID:24010055

  1. Ameliorating children's reading-comprehension difficulties: a randomized controlled trial.

    PubMed

    Clarke, Paula J; Snowling, Margaret J; Truelove, Emma; Hulme, Charles

    2010-08-01

    Children with specific reading-comprehension difficulties can read accurately, but they have poor comprehension. In a randomized controlled trial, we examined the efficacy of three interventions designed to improve such children's reading comprehension: text-comprehension (TC) training, oral-language (OL) training, and TC and OL training combined (COM). Children were assessed preintervention, midintervention, postintervention, and at an 11-month follow-up. All intervention groups made significant improvements in reading comprehension relative to an untreated control group. Although these gains were maintained at follow-up in the TC and COM groups, the OL group made greater gains than the other groups did between the end of the intervention and follow-up. The OL and COM groups also demonstrated significant improvements in expressive vocabulary compared with the control group, and this was a mediator of the improved reading comprehension of the OL and COM groups. We conclude that specific reading-comprehension difficulties reflect (at least partly) underlying oral-language weaknesses that can be effectively ameliorated by suitable teaching. PMID:20585051

  2. Treatment of bulimia nervosa with sertraline: a randomized controlled trial.

    PubMed

    Milano, W; Petrella, C; Sabatino, C; Capasso, A

    2004-01-01

    Bulimia nervosa (BN) is one of the most frequently encountered eating disorders in industrialized societies. It has been suggested that reduced serotonin activity may trigger some of the cognitive and mood disturbances associated with BN. Thus, pharmacologic treatment of BN is mainly based on the use of selective serotonin reuptake inhibitors, which have proved effective. At present, the biological basis of this disorder is not completely clear. The aim of this randomized, controlled trial was to verify the efficacy of sertraline, a selective serotonin reuptake inhibitor, in a group of patients with a diagnosis of BN. Twenty female outpatients, with an age range of 24 to 36 years and a diagnosis of purging type BN as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV), were assigned randomly to two treatment groups. The first group received sertraline 100 mg/day for 12 weeks; the second group received placebo. The study was conducted for 12 weeks, with weekly clinical assessments. At the end of the observation period, the group treated with sertraline had a statistically significant reduction in the number of binge eating crises and purging compared with the group who received placebo. In no case was treatment interrupted because of side effects. This study confirms that sertraline is well tolerated and effective in reducing binge-eating crises and purging in patients with BN. PMID:15605617

  3. A Group-Based Yoga Therapy Intervention for Urinary Incontinence in Women: A Pilot Randomized Trial

    PubMed Central

    Huang, Alison J.; Jenny, Hillary E.; Chesney, Margaret A.; Schembri, Michael; Subak, Leslee L.

    2015-01-01

    Objective To examine the feasibility, efficacy, and safety of a group-based yoga therapy intervention for middle-aged and older women with urinary incontinence. Methods We conducted a pilot randomized trial of ambulatory women aged 40 years and older with stress, urgency, or mixed-type incontinence. Women were randomized to a 6-week yoga therapy program (N=10) consisting of twice weekly group classes and once weekly home practice or a waitlist control group (N=9). All participants also received written pamphlets about standard behavioral self-management strategies for incontinence. Changes in incontinence were assessed by 7-day voiding diaries. Results Mean (±SD) age was 61.4 (±8.2) years, and mean baseline frequency of incontinence was 2.5 (±1.3) episodes/day. After 6 weeks, total incontinence frequency decreased by 66% (1.8 [±0.9] fewer episodes/day) in the yoga therapy versus 13% (0.3 [±1.7] fewer episodes/day) in the control group (P=0.049). Participants in the yoga therapy group also reported an average 85% decrease in stress incontinence frequency (0.7 [±0.8] fewer episodes/day) compared to a 25% increase in controls (0.2 [± 1.1] more episodes/day) (P=0.039). No significant differences in reduction in urgency incontinence were detected between the yoga therapy versus control groups (1.0 [±1.0] versus 0.5 [±0.5] fewer episodes/day, P=0.20). All women starting the yoga therapy program completed at least 90% of group classes and practice sessions. Two participants in each group reported adverse events unrelated to the intervention. Conclusions Findings provide preliminary evidence to support the feasibility, efficacy, and safety of a group-based yoga therapy intervention to improve urinary incontinence in women. PMID:24763156

  4. A sorrow shared is a sorrow halved? A three-arm randomized controlled trial comparing internet-based clinician-guided individual versus group treatment for social anxiety disorder.

    PubMed

    Schulz, Ava; Stolz, Timo; Vincent, Alessia; Krieger, Tobias; Andersson, Gerhard; Berger, Thomas

    2016-09-01

    A growing body of evidence suggests that internet-based cognitive behavioural treatments (ICBT) are effective to treat social anxiety disorder (SAD). Whereas the efficacy of clinician-guided ICBT has been established, ICBT in a group format has not yet been systematically investigated. This three-arm RCT compared the efficacy of clinician-guided group ICBT (GT) with clinician guided individual ICBT (IT) and a wait-list (WL). A total of 149 individuals meeting the diagnostic criteria for SAD were randomly assigned to one of three conditions. Primary endpoints were self-report measures of SAD and diagnostic status taken at baseline, after the twelve-week intervention and at six-month follow-up. Secondary endpoints were symptoms of depression, interpersonal problems and general symptomatology. At post-treatment, both active conditions showed superior outcome regarding SAD symptoms (GT vs. WL: d = 0.84-0.74; IT vs. WL: d = 0.94-1.22). The two active conditions did not differ significantly in symptom reduction (d = 0.12-0.26, all ps > 0.63), diagnostic response rate or attrition. Treatment gains were maintained at follow-up. The group format reduced weekly therapist time per participant by 71% (IT: 17 min, GT: 5 min). Findings indicate that a clinician-guided group format is a promising approach in treating SAD. PMID:27423374

  5. Periodic or random nanostructures for light scattering control

    NASA Astrophysics Data System (ADS)

    Berginc, Gerard

    2016-04-01

    Our paper mainly focuses on the control of light scattering by periodic or randomly rough structures. First designed with bi-periodical structures, antireflective surfaces can be achieved with random patterns. We present some new structures with periodic or random patterns, which have been designed by rigorous numerical methods (FDTD) or analytical methods. We show that random interfaces offer new degrees of freedom and possibilities by control of their statistical properties.

  6. Attitude Control Working Group report

    NASA Technical Reports Server (NTRS)

    Reid, Daniel F.; Studer, Phillip A.

    1986-01-01

    The goals were to establish the Attitude Control System (ACS) requirements, constraints, technology assessment, technology shortfalls, expected in the year 2000. These were based upon all missions, military and civil, for LEO and GEO. The critical ACS technology issues were identified and ACS programs developed to address these critical issues.

  7. Similar Blood Pressure Values Across Racial and Economic Groups: Baseline Data from a Group Randomized Clinical Trial

    PubMed Central

    Carter, Barry L.; Coffey, Christopher S.; Uribe, Liz; James, Paul A.; Egan, Brent M.; Ardery, Gail; Chrischilles, Elizabeth A.; Ecklund, Dixie; Weg, Mark Vander; Vaughn, Thomas

    2013-01-01

    This paper examines baseline characteristics from a prospective, cluster-randomized trial in 32 primary care offices. Offices were first stratified by percent minorities and level of clinical pharmacy services and then randomized into one of three study groups. The only differences between randomized arms were for marital status (p=0.03) and type of insurance coverage (p<0.001). BPs were similar in Caucasians and minority subjects, primarily Blacks, who were hypertensive at baseline. On multivariate analyses, subjects who were ≥ 65 years of age had higher systolic BP (SBP) (152.4 ± 14.3 mm Hg), but lower diastolic BP (DBP) (77.3 ± 11.8 mm Hg) compared to those <65 years of age (147.4 ± 15.0/88.6 ± 10.6 mm Hg, p<0.001 for both SBP and DBP). Other factors significantly associated with higher SBP were a longer duration of hypertension (p=0.04) and lower basal metabolic index (BMI) (p=0.011). Subjects with diabetes or chronic kidney disease (CKD) had a lower SBP than those without these conditions (p<0.0001). BP was similar across racial and socioeconomic groups for subjects with uncontrolled hypertension in primary care suggesting that subjects with uncontrolled hypertension and an established primary care relationship likely have different reasons for poor BP control than other patient populations. PMID:23730989

  8. Emphasized warning reduces salt intake: a randomized controlled trial.

    PubMed

    Pinjuh Markota, Nina; Rumboldt, Mirjana; Rumboldt, Zvonko

    2015-03-01

    Excessive salt intake is a major cardiovascular risk factor. At variance to the developed countries, the main source of sodium in transitional and developing countries is salt added while cooking and/or at the table. The objective of this trial was to examine the impact of warning labels placed on home salt containers on daily salt intake.A sample of treated hypertensives (n = 150) was randomized in two subgroups, one receiving just a leaflet about the harmful effects of excessive salt intake (control; n = 74), and the other one receiving in addition warning stickers for household salt containers (intervention; n = 76). Arterial blood pressure (BP) and 24-hour urinary sodium excretion (Na24) were measured in all the subjects at the start of the trial, and 1 month and 2 months later. The average starting Na24 was 207 ± 71 mmol in the control group and 211 ± 85 mmol in the intervention group (P = .745). One month and 2 months later, a significant decrease was observed in the intervention group (to 183 ± 63 mmol and 176 ± 55 mmol; P < .0001), as opposed to the control group (203 ± 60 mmol and 200 ± 58 mmol; P = .1466). Initial BP was 143.7/84.1 mm Hg in the control, and 142.9/84.7 mm Hg in the intervention group (P = .667). One month and 2 months later, a significant drop in BP, by 5.3/2.9 mm Hg, was observed in the intervention group as opposed to the control group (0.4/0.9 mm Hg). Decrease in Na24 positively correlated to BP lowering (r(2) = 0.5989; P < .0001). A significant reduction in 24Na and BP is achieved with warning labels on harmful effects of excessive salt intake. Decreasing daily salt input by 35 mmol may result in an extra BP lowering by some 5-6/2-3 mm Hg. PMID:25659228

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

    PubMed

    Jafari, Nahid; Hearne, John; Churilov, Leonid

    2013-11-10

    A post-hoc individual patient matching procedure was recently proposed within the context of parallel group randomized clinical trials (RCTs) as a method for estimating treatment effect. In this paper, we consider a post-hoc individual patient matching problem within a parallel group RCT as a multi-objective decision-making problem focussing on the trade-off between the quality of individual matches and the overall percentage of matching. Using acute stroke trials as a context, we utilize exact optimization and simulation techniques to investigate a complex relationship between the overall percentage of individual post-hoc matching, the size of the respective RCT, and the quality of matching on variables highly prognostic for a good functional outcome after stroke, as well as the dispersion in these variables. It is empirically confirmed that a high percentage of individual post-hoc matching can only be achieved when the differences in prognostic baseline variables between individually matched subjects within the same pair are sufficiently large and that the unmatched subjects are qualitatively different to the matched ones. It is concluded that the post-hoc individual matching as a technique for treatment effect estimation in parallel-group RCTs should be exercised with caution because of its propensity to introduce significant bias and reduce validity. If used with appropriate caution and thorough evaluation, this approach can complement other viable alternative approaches for estimating the treatment effect. PMID:23761106

  10. Cognitive Stimulation in Patients with Dementia: Randomized Controlled Trial

    PubMed Central

    Mapelli, Daniela; Di Rosa, Elisa; Nocita, Rosaria; Sava, Donatella

    2013-01-01

    Background/Aims This study explores the effective outcomes of a structured cognitive stimulation treatment to improve cognition and behavioral symptoms in people with dementia (PWDs), using a randomized controlled clinical trial. Methods Thirty PWDs were divided into three groups: experimental (treated with cognitive stimulation), placebo (treated with occupational therapy), and control (continuing with the usual activities of the nursing home). Assessment, at baseline and after a period of 8 weeks, was performed using the Clinical Dementia Rating Scale, activities of daily living, Mini-Mental State Examination, Esame Neuropsicologico Breve 2, Geriatric Depression Scale and Behavioral Pathology in Alzheimer's Disease Scale. Results Only the experimental group improved its performance in cognitive tests (p < 0.05) and showed a significant decrease in behavioral symptoms (p < 0.01) after the treatment. Conclusions The results suggest that a cognitive stimulation treatment for PWDs would improve not only their cognition, but also behavioral symptoms. PMID:24052800

  11. Study protocol of the Diabetes and Depression Study (DAD): a multi-center randomized controlled trial to compare the efficacy of a diabetes-specific cognitive behavioral group therapy versus sertraline in patients with major depression and poorly controlled diabetes mellitus

    PubMed Central

    2013-01-01

    Background Depression is common in diabetes and associated with hyperglycemia, diabetes related complications and mortality. No single intervention has been identified that consistently leads to simultaneous improvement of depression and glycemic control. Our aim is to analyze the efficacy of a diabetes-specific cognitive behavioral group therapy (CBT) compared to sertraline (SER) in adults with depression and poorly controlled diabetes. Methods/Design This study is a multi-center parallel arm randomized controlled trial currently in its data analysis phase. We included 251 patients in 70 secondary care centers across Germany. Key inclusion criteria were: type 1 or 2 diabetes, major depression (diagnosed with the Structured Clinical Interview for DSM-IV, SCID) and hemoglobin A1C >7.5% despite current insulin therapy. During the initial phase, patients received either 50–200 mg/d sertraline or 10 CBT sessions aiming at the remission of depression and enhanced adherence to diabetes treatment and coping with diabetes. Both groups received diabetes treatment as usual. After 12 weeks of this initial open-label therapy, only the treatment-responders (50% depression symptoms reduction, Hamilton Depression Rating Scale, 17-item version [HAMD]) were included in the subsequent one year study phase and represented the primary analysis population. CBT-responders received no further treatment, while SER-responders obtained a continuous, flexible-dose SER regimen as relapse prevention. Adherence to treatment was analyzed using therapeutic drug monitoring (measurement of sertraline and N-desmethylsertraline concentrations in blood serum) and by counting the numbers of CBT sessions received. Outcome assessments were conducted by trained psychologists blinded to group assignment. Group differences in HbA1c (primary outcome) and depression (HAMD, secondary outcome) between 1-year follow-up and baseline will be analyzed by ANCOVA controlling for baseline values. As primary

  12. Prenatal emotion management improves obstetric outcomes: a randomized control study

    PubMed Central

    Huang, Jian; Li, He-Jiang; Wang, Jue; Mao, Hong-Jing; Jiang, Wen-Ying; Zhou, Hong; Chen, Shu-Lin

    2015-01-01

    Introduction: Negative emotions can cause a number of prenatal problems and disturb obstetric outcomes. We determined the effectiveness of prenatal emotional management on obstetric outcomes in nulliparas. Methods: All participants completed the PHQ-9 at the baseline assessment. Then, the participants were randomly assigned to the emotional management (EM) and usual care (UC) groups. The baseline evaluation began at 31 weeks gestation and the participants were followed up to 42 days postpartum. Each subject in the EM group received an extra EM program while the participants in the UC groups received routine prenatal care and education only. The PHQ-9 and Edinburgh Postnatal Depression scale (EPDS) were used for assessment. Results: The EM group had a lower PHQ-9 score at 36 weeks gestation, and 7 and 42 days after delivery (P < 0.01), and a lower EPDS score 42 days postpartum (P < 0.05). The rate of cesarean section in the EM group was lower than the UC group (P < 0.01), and the cesarean section rate without a medical indication was lower (P < 0.01). The duration of the second stage of labor in the EM group was shorter than the UC group (P < 0.01). Conclusions: Prenatal EM intervention could control anxiety and depressive feelings in nulliparas, and improve obstetric outcomes. It may serve as an innovative approach to reduce the cesarean section rate in China. PMID:26309641

  13. Randomized controlled trials - a matter of design.

    PubMed

    Spieth, Peter Markus; Kubasch, Anne Sophie; Penzlin, Ana Isabel; Illigens, Ben Min-Woo; Barlinn, Kristian; Siepmann, Timo

    2016-01-01

    Randomized controlled trials (RCTs) are the hallmark of evidence-based medicine and form the basis for translating research data into clinical practice. This review summarizes commonly applied designs and quality indicators of RCTs to provide guidance in interpreting and critically evaluating clinical research data. It further reflects on the principle of equipoise and its practical applicability to clinical science with an emphasis on critical care and neurological research. We performed a review of educational material, review articles, methodological studies, and published clinical trials using the databases MEDLINE, PubMed, and ClinicalTrials.gov. The most relevant recommendations regarding design, conduction, and reporting of RCTs may include the following: 1) clinically relevant end points should be defined a priori, and an unbiased analysis and report of the study results should be warranted, 2) both significant and nonsignificant results should be objectively reported and published, 3) structured study design and performance as indicated in the Consolidated Standards of Reporting Trials statement should be employed as well as registration in a public trial database, 4) potential conflicts of interest and funding sources should be disclaimed in study report or publication, and 5) in the comparison of experimental treatment with standard care, preplanned interim analyses during an ongoing RCT can aid in maintaining clinical equipoise by assessing benefit, harm, or futility, thus allowing decision on continuation or termination of the trial. PMID:27354804

  14. Efficacy of Yoga for Vasomotor Symptoms: A Randomized Controlled Trial

    PubMed Central

    Newton, Katherine M.; Reed, Susan D.; Guthrie, Katherine A.; Sherman, Karen J.; Booth-LaForce, Cathryn; Caan, Bette; Sternfeld, Barbara; Carpenter, Janet S.; Learman, Lee A.; Freeman, Ellen W.; Cohen, Lee S.; Joffe, Hadine; Anderson, Garnet L.; Larson, Joseph C.; Hunt, Julie R.; Ensrud, Kristine E.; LaCroix, Andrea Z.

    2013-01-01

    Objective To determine the efficacy of yoga in alleviating VMS frequency and bother. Methods Three by two factorial design, randomized, controlled. Eligible women were randomized to yoga (n=107), exercise (n=106), or usual activity (n=142), and were simultaneously randomized to double-blind comparison of omega-3 fatty acid (n=177) or placebo (n=178) capsules. Yoga intervention was twelve, weekly, 90-minute yoga classes with daily home practice. Primary outcomes were VMS frequency and bother assessed by daily diaries at baseline, 6, and 12 weeks. Secondary outcomes included insomnia symptoms (Insomnia Severity Index) at baseline and 12 weeks. Results Among 249 randomized women, 237 (95%) completed 12-week assessments. Mean baseline VMS frequency was 7.4/day (95% CI 6.6, 8.1) in the yoga group and 8.0/day (95% CI 7.3, 8.7) in the usual activity group. Intent-to-treat analyses included all participants with response data (n=237). There was no difference between intervention groups in change in VMS frequency from baseline to 6 and 12 weeks (mean difference (yoga – usual activity) from baseline −0.3 (95% CI −1.1, 0.5) at 6 weeks and −0.3 (95% CI −1.2, 0.6) at 12 weeks (p=0.119 across both time points). Results were similar for VMS bother. At week 12, yoga was associated with an improvement in insomnia symptoms (mean difference [yoga-usual activity] in change –Insomnia Severity Index, 1.3 [95% CI −2.5, −0.1][p=0.007]). Conclusion Among healthy women, 12 weeks of yoga class plus home practice compared with usual activity did not improve VMS frequency or bother, but reduced insomnia symptoms. PMID:24045673

  15. Treatment of bulimia nervosa with fluvoxamine: a randomized controlled trial.

    PubMed

    Milano, W; Siano, C; Putrella, C; Capasso, A

    2005-01-01

    Bulimia nervosa (BN) is one of the most common eating disorders in industrialized societies. It has been suggested that reduced serotonin activity triggers some of the cognitive and mood disturbances associated with BN. For this reason, the pharmacologic treatment of BN consists mainly of selective serotonin reuptake inhibitors (SSRIs), which have been proven effective. At present, the physiologic bases of this disorder are not yet completely understood. We conducted a randomized controlled trial to verify the efficacy of the SSRI fluvoxamine in patients with a diagnosis of BN. Twelve female outpatients aged 21 to 34 years with a diagnosis of BN-binge purging (as defined by the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders [DSM IV]) were randomly assigned to 2 treatment groups: the fluvoxamine 200 mg/day group and the placebo group. The patients underwent weekly clinical assessments for 12 weeks. At the end of the observation period, there was a statistically significant reduction in the number of binge-eating crises and purging episodes in the fluvoxamine group compared with placebo. In no case was treatment interrupted because of emergent side effects. These findings support the hypothesis that fluvoxamine is well tolerated and effective in reducing binge-eating crises and purging episodes in patients with BN. PMID:16236688

  16. Reiki for the Treatment of Fibromyalgia: A Randomized Controlled Trial

    PubMed Central

    Assefi, Nassim; Bogart, Andy; Goldberg, Jack

    2008-01-01

    Abstract Objective Fibromyalgia is a common, chronic pain condition for which patients frequently use complementary and alternative medicine, including Reiki. Our objective was to determine whether Reiki is beneficial as an adjunctive fibromyalgia treatment. Design This was a factorial designed, randomized, sham-controlled trial in which participants, data collection staff, and data analysts were blinded to treatment group. Setting/location The study setting was private medical offices in the Seattle, Washington metropolitan area. Subjects The subjects were comprised 100 adults with fibromyalgia. Intervention Four (4) groups received twice-weekly treatment for 8 weeks by either a Reiki master or actor randomized to use direct touch or no touch (distant therapy). Outcome measures The primary outcome was subjective pain as measured by visual analog scale at weeks 4, 8, and 20 (3 months following end of treatment). Secondary outcomes were physical and mental functioning, medication use, and health provider visits. Participant blinding and adverse effects were ascertained by selfreport. Improvement between groups was examined in an intention-to-treat analysis. Results Neither Reiki nor touch had any effect on pain or any of the secondary outcomes. All outcome measures were nearly identical among the 4 treatment groups during the course of the trial. Conclusion Neither Reiki nor touch improved the symptoms of fibromyalgia. Energy medicine modalities such as Reiki should be rigorously studied before being recommended to patients with chronic pain symptoms. PMID:18991519

  17. The Effectiveness of Propolis on Gingivitis: A Randomized Controlled Trial

    PubMed Central

    Paulino, Niraldo; Nör, Jacques E.; Moreira, Alexandre

    2014-01-01

    Abstract Background: A randomized, double-blind, controlled clinical trial was conducted to evaluate the effectiveness of a propolis rinse on induced gingivitis by using the co-twin study design. Methods: Twenty-one twin pairs (n=42) were enrolled in a gingivitis study with oral hygiene promotion (14 days) and gingivitis induction (21 days). During the gingivitis induction phase, one member of the twin pair was randomly assigned to a 2% typified propolis rinse, and the other was assigned a color-matched 0.05% sodium fluoride plus 0.05% cetylpyridinium chloride rinse (positive control). Patients rinsed twice daily with 20 mL for 30 seconds for 21 days. Gingivitis was measured on days −14 (baseline), 0 (after hygiene phase), and 21 (after no-hygiene phase) by using the Papillary Bleeding Score (PBS) and by standard digital imaging of the gum tissues (G-parameter). Results: The 38 persons who completed the study (age 13–22 years) were well balanced according to PBS at baseline and G-parameter after the initial hygiene phase. After 21 days without oral hygiene, the propolis rinse and positive control rinse groups did not differ significantly for average PBS measurements or G-parameter. Conclusions: Use of a 2% typified propolis rinse was equivalent to a positive control rinse during a 21-day no-hygiene period. PMID:25380344

  18. Estimating the minimum control count of random network models

    PubMed Central

    Ruths, Derek; Ruths, Justin

    2016-01-01

    The study of controllability of complex networks has introduced the minimum number of controls required for full controllability as a new network measure of interest. This network measure, like many others, is non-trivial to compute. As a result, establishing the significance of minimum control counts (MCCs) in real networks using random network null models is expensive. Here we derive analytic estimates for the expected MCCs of networks drawn from three commonly-used random network models. Our estimates show good agreement with exact control counts. Furthermore, the analytic expressions we derive offer insights into the structures within each random network model that induce the need for controls. PMID:26817434

  19. A Canadian Critical Care Trials Group project in collaboration with the international forum for acute care trialists - Collaborative H1N1 Adjuvant Treatment pilot trial (CHAT): study protocol and design of a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Swine origin influenza A/H1N1 infection (H1N1) emerged in early 2009 and rapidly spread to humans. For most infected individuals, symptoms were mild and self-limited; however, a small number developed a more severe clinical syndrome characterized by profound respiratory failure with hospital mortality ranging from 10 to 30%. While supportive care and neuraminidase inhibitors are the main treatment for influenza, data from observational and interventional studies suggest that the course of influenza can be favorably influenced by agents not classically considered as influenza treatments. Multiple observational studies have suggested that HMGCoA reductase inhibitors (statins) can exert a class effect in attenuating inflammation. The Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial sought to investigate the feasibility of conducting a trial during a global pandemic in critically ill patients with H1N1 with the goal of informing the design of a larger trial powered to determine impact of statins on important outcomes. Methods/Design A multi-national, pilot randomized controlled trial (RCT) of once daily enteral rosuvastatin versus matched placebo administered for 14 days for the treatment of critically ill patients with suspected, probable or confirmed H1N1 infection. We propose to randomize 80 critically ill adults with a moderate to high index of suspicion for H1N1 infection who require mechanical ventilation and have received antiviral therapy for ≤ 72 hours. Site investigators, research coordinators and clinical pharmacists will be blinded to treatment assignment. Only research pharmacy staff will be aware of treatment assignment. We propose several approaches to informed consent including a priori consent from the substitute decision maker (SDM), waived and deferred consent. The primary outcome of the CHAT trial is the proportion of eligible patients enrolled in the study. Secondary outcomes will evaluate adherence to medication administration

  20. Maternal Dietary Counseling Reduces Consumption of Energy-Dense Foods among Infants: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Vitolo, Marcia Regina; Bortolini, Gisele Ane; Campagnolo, Paula Dal Bo; Hoffman, Daniel J.

    2012-01-01

    Objective: To evaluate the impact of a dietary counseling in reducing the intake of energy-dense foods by infants. Design: A randomized controlled trial. Setting and Participants: Sao Leopoldo, Brazil. Mothers and infants of a low-income-group population were randomized into intervention (n = 163) and received dietary counseling during 10 home…

  1. Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial

    PubMed Central

    Gomes, Evelim L. F. D.; Carvalho, Celso R. F.; Peixoto-Souza, Fabiana Sobral; Teixeira-Carvalho, Etiene Farah; Mendonça, Juliana Fernandes Barreto; Stirbulov, Roberto; Sampaio, Luciana Maria Malosá; Costa, Dirceu

    2015-01-01

    Objective The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma. Design A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20) or a treadmill group (TG; n = 16). Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO), maximum exercise testing (Bruce protocol) and lung function. Results No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p < 0.05). Although the mean energy expenditure at rest and during exercise training was similar for both groups, the maximum energy expenditure was higher in the VGG. Conclusion The present findings strongly suggest that aerobic training promoted by an active video game had a positive impact on children with asthma in terms of clinical control, improvementin their exercise capacity and a reductionin pulmonary inflammation. Trial Registration Clinicaltrials.gov NCT01438294 PMID:26301706

  2. Randomized Controlled Trials in Environmental Health Research: Ethical Issues

    PubMed Central

    Resnik, David B.

    2009-01-01

    Background Randomized controlled trials (RCTs) are becoming increasingly common in environmental health research. Like all studies involving human subjects, environmental health RCTs raise many different ethical issues, ranging from obtaining informed consent, to minimizing risks, to protecting privacy and confidentiality. One of the most important issues raised by these studies is whether it is ethical to withhold effective environmental health interventions from research subjects in order to satisfy scientific objectives. Although environmental health investigators usually do not have professional obligations to provide medical care to research subjects, they have ethical obligations to avoid exploiting them. Withholding interventions from research subjects can be ethical, provided that it does not lead to exploitation of individuals or groups. To avoid exploiting individuals or groups, investigators should ensure that research subjects and study populations receive a fair share of the benefits of research. PMID:18236934

  3. How chaosity and randomness control human health

    NASA Astrophysics Data System (ADS)

    Yulmetyev, Renat M.; Yulmetyeva, Dinara; Gafarov, Fail M.

    2005-08-01

    We discuss the fundamental role that chaosity and randomness play in the determination of quality and efficiency of medical treatment. The statistical parameter of non-Markovity from non-equilibrium statistical physics of condensed matters is offered as a quantitative information measure of chaosity and randomness. The role of chaosity and randomness is determined by the phenomenological property, which includes quantitative informational measures of chaosity and randomness and pathology (disease) in a covariant form. Manifestations of the statistical informational behavior of chaosity and randomness are examined while analyzing the chaotic dynamics of RR intervals from human ECG's, the electric signals of a human muscle's tremor of legs in a normal state and at Parkinson disease, the electric potentials of the human brain core from EEG's during epileptic seizure and a human hand finger tremor in Parkinson's disease. The existence of the above stated informational measure allows to introduce the quantitative factor of the quality of treatment. The above-stated examples confirm the existence of new phenomenological property, which is important not only for the decision of medical problems, but also for the analysis of the wide range of problems of physics of complex systems of life and lifeless nature.

  4. Effects of nattokinase on blood pressure: a randomized, controlled trial.

    PubMed

    Kim, Ji Young; Gum, Si Nae; Paik, Jean Kyung; Lim, Hyo Hee; Kim, Kyong-Chol; Ogasawara, Kazuya; Inoue, Kenichi; Park, Sungha; Jang, Yangsoo; Lee, Jong Ho

    2008-08-01

    The objective of this study was to examine the effects of nattokinase supplementation on blood pressure in subjects with pre-hypertension or stage 1 hypertension. In a randomized, double-blind, placebo-controlled trial, 86 participants ranging from 20 to 80 years of age with an initial untreated systolic blood pressure (SBP) of 130 to 159 mmHg received nattokinase (2,000 FU/capsule) or a placebo capsule for 8 weeks. Seventy-three subjects completed the protocol. Compared with the control group, the net changes in SBP and diastolic blood pressure (DBP) were -5.55 mmHg (95% confidence interval [CI], -10.5 to -0.57 mmHg; p<0.05) and -2.84 mmHg (CI, -5.33 to -0.33 mmHg; p<0.05), respectively, after the 8-week intervention. The corresponding net change in renin activity was -1.17 ng/mL/h for the nattokinase group compared with the control group (p<0.05). In conclusion, nattokinase supplementation resulted in a reduction in SBP and DBP. These findings suggest that increased intake of nattokinase may play an important role in preventing and treating hypertension. PMID:18971533

  5. Medication reconciliation at patient admission: a randomized controlled trial

    PubMed Central

    Mendes, Antonio E.; Lombardi, Natália F.; Andrzejevski, Vânia S.; Frandoloso, Gibran; Correr, Cassyano J.; Carvalho, Mauricio

    2015-01-01

    Objective: To measure length of hospital stay (LHS) in patients receiving medication reconciliation. Secondary characteristics included analysis of number of preadmission medications, medications prescribed at admission, number of discrepancies, and pharmacists interventions done and accepted by the attending physician. Methods: A 6 month, randomized, controlled trial conducted at a public teaching hospital in southern Brazil. Patients admitted to general wards were randomized to receive usual care or medication reconciliation, performed within the first 72 hours of hospital admission. Results: The randomization process assigned 68 patients to UC and 65 to MR. LHS was 10±15 days in usual care and 9±16 days in medication reconciliation (p=0.620). The total number of discrepancies was 327 in the medication reconciliation group, comprising 52.6% of unintentional discrepancies. Physicians accepted approximately 75.0% of the interventions. Conclusion: These results highlight weakness at patient transition care levels in a public teaching hospital. LHS, the primary outcome, should be further investigated in larger studies. Medication reconciliation was well accepted by physicians and it is a useful tool to find and correct discrepancies, minimizing the risk of adverse drug events and improving patient safety. PMID:27011775

  6. Naturopathic Care for Anxiety: A Randomized Controlled Trial ISRCTN78958974

    PubMed Central

    Cooley, Kieran; Szczurko, Orest; Perri, Dan; Mills, Edward J.; Bernhardt, Bob; Zhou, Qi; Seely, Dugald

    2009-01-01

    Background Anxiety is a serious personal health condition and represents a substantial burden to overall quality of life. Additionally anxiety disorders represent a significant cost to the health care system as well as employers through benefits coverage and days missed due to incapacity. This study sought to explore the effectiveness of naturopathic care on anxiety symptoms using a randomized trial. Methods Employees with moderate to severe anxiety of longer than 6 weeks duration were randomized based on age and gender to receive naturopathic care (NC) (n = 41) or standardized psychotherapy intervention (PT) (n = 40) over a period of 12 weeks. Blinding of investigators and participants during randomization and allocation was maintained. Participants in the NC group received dietary counseling, deep breathing relaxation techniques, a standard multi-vitamin, and the herbal medicine, ashwagandha (Withania somnifera) (300 mg b.i.d. standardized to 1.5% withanolides, prepared from root). The PT intervention received psychotherapy, and matched deep breathing relaxation techniques, and placebo. The primary outcome measure was the Beck Anxiety Inventory (BAI) and secondary outcome measures included the Short Form 36 (SF-36), Fatigue Symptom Inventory (FSI), and Measure Yourself Medical Outcomes Profile (MY-MOP) to measure anxiety, mental health, and quality of life respectively. Participants were blinded to the placebo-controlled intervention. Results Seventy-five participants (93%) were followed for 8 or more weeks on the trial. Final BAI scores decreased by 56.5% (p<0.0001) in the NC group and 30.5% (p<0.0001) in the PT group. BAI group scores were significantly decreased in the NC group compared to PT group (p = 0.003). Significant differences between groups were also observed in mental health, concentration, fatigue, social functioning, vitality, and overall quality of life with the NC group exhibiting greater clinical benefit. No serious adverse reactions

  7. Digital servo control of random sound fields

    NASA Technical Reports Server (NTRS)

    Nakich, R. B.

    1973-01-01

    It is necessary to place number of sensors at different positions in sound field to determine actual sound intensities to which test object is subjected. It is possible to determine whether specification is being met adequately or exceeded. Since excitation is of random nature, signals are essentially coherent and it is impossible to obtain true average.

  8. Quantum decomposition of random walk on Cayley graph of finite group

    NASA Astrophysics Data System (ADS)

    Kang, Yuanbao

    2016-09-01

    In the paper, A quantum decomposition (QD, for short) of random walk on Cayley graph of finite group is introduced, which contains two cases. One is QD of quantum random walk operator (QRWO, for short), another is QD of Quantum random walk state (QRWS, for short). Using these findings, I finally obtain some applications for quantum random walk (QRW, for short), which are of interest in the study of QRW, highlighting the role played by QRWO and QRWS.

  9. Efficacy and Safety of FospropofolFD Compared to Propofol When Given During the Induction of General Anaesthesia: A Phase II, Multi-centre, Randomized, Parallel-Group, Active-Controlled, Double-Blind, Double-Dummy Study.

    PubMed

    Liu, Rong; Luo, Chaozhi; Liu, Jin; Zhang, Wensheng; Li, Yan; Xu, Jing

    2016-07-01

    The present phase II study aimed to compare the efficacy and safety of fospropofol disodium for injection (FospropofolFD ) and propofol when given during the induction of general anaesthesia in patients scheduled for elective surgery. FospropofolFD is a water-soluble prodrug of propofol. Approved by the Ethical Committee, 240 participants aged 18-65 years were equally randomly allocated to receive an intravenous bolus of FospropofolFD 20 mg/kg or propofol 2 mg/kg without any anaesthetic pre-treatment. The primary efficacy end-point was the sedation success rate within 5 min. after administering investigational drugs (the sedation success is defined as obtaining Modified Observer's Assessment of Alertness/Sedation scale score of 1). All the participants completed the induction and intubation within 25 min. after administration. The sedation success rates within 5 min. after administration of FospropofolFD 20 mg/kg and propofol 2 mg/kg were 94.50% versus 100% in the intention-to-treat population and 95.10% versus 100% in the per-protocol population, respectively. The non-inferiority test obtained a p-value less than 0.025, and the lower limits of the one-sided 97.5% confidence interval were more than -0.09. This meant that FospropofolFD 20 mg/kg was considered non-inferior to propofol 2 mg/kg for the primary efficacy end-point. Compared with propofol 2 mg/kg, FospropofolFD 20 mg/kg had a slower sedation efficacy. No serious adverse events were observed in the two groups. The sedation success rate within 5 min. after administration of FospropofolFD 20 mg/kg was non-inferior to propofol 2 mg/kg, and FospropofolFD 20 mg/kg can be used for the induction of general anaesthesia safely. PMID:26781338

  10. The Effects of School Gardens on Children's Science Knowledge: A Randomized Controlled Trial of Low-Income Elementary Schools

    ERIC Educational Resources Information Center

    Wells, Nancy M.; Myers, Beth M.; Todd, Lauren E.; Barale, Karen; Gaolach, Brad; Ferenz, Gretchen; Aitken, Martha; Henderson, Charles R.; Tse, Caroline; Pattison, Karen Ostlie; Taylor, Cayla; Connerly, Laura; Carson, Janet B.; Gensemer, Alexandra Z.; Franz, Nancy K.; Falk, Elizabeth

    2015-01-01

    This randomized controlled trial or "true experiment" examines the effects of a school garden intervention on the science knowledge of elementary school children. Schools were randomly assigned to a group that received the garden intervention (n?=?25) or to a waitlist control group that received the garden intervention at the end of the…

  11. Identification of non-random sequence properties in groups of signature peptides obtained in random sequence peptide microarray experiments.

    PubMed

    Kuznetsov, Igor B

    2016-05-01

    Immunosignaturing is an emerging experimental technique that uses random sequence peptide microarrays to detect antibodies produced by the immune system in response to a particular disease. Two important questions regarding immunosignaturing are "Do microarray peptides that exhibit a strong affinity to a given type of antibodies share common sequence properties?" and "If so, what are those properties?" In this work, three statistical tests designed to detect non-random patterns in the amino acid makeup of a group of microarray peptides are presented. One test detects patterns of significantly biased amino acid usage, whereas the other two detect patterns of significant bias in the biochemical properties. These tests do not require a large number of peptides per group. The tests were applied to analyze 19 groups of peptides identified in immunosignaturing experiments as being specific for antibodies produced in response to various types of cancer and other diseases. The positional distribution of the biochemical properties of the amino acids in these 19 peptide groups was also studied. Remarkably, despite the random nature of the sequence libraries used to design the microarrays, a unique group-specific non-random pattern was identified in the majority of the peptide groups studied. © 2016 Wiley Periodicals, Inc. Biopolymers (Pept Sci) 106: 318-329, 2016. PMID:27037995

  12. A Randomized Controlled Trial of Storytelling as a Communication Tool

    PubMed Central

    Hartling, Lisa; Scott, Shannon D.; Johnson, David W.; Bishop, Ted; Klassen, Terry P.

    2013-01-01

    Introduction Stories may be an effective tool to communicate with patients because of their ability to engage the reader. Our objective was to evaluate the effectiveness of story booklets compared to standard information sheets for parents of children attending the emergency department (ED) with a child with croup. Methods Parents were randomized to receive story booklets (n=208) or standard information sheets (n=205) during their ED visit. The primary outcome was change in anxiety between triage to ED discharge as measured by the State-Trait Anxiety Inventory. Follow-up telephone interviews were conducted at 1 and 3 days after discharge, then every other day until 9 days (or until resolution of symptoms), and at 1 year. Secondary outcomes included: expected future anxiety, event impact, parental knowledge, satisfaction, decision regret, healthcare utilization, time to symptom resolution. Results There was no significant difference in the primary outcome of change in parental anxiety between recruitment and ED discharge (change of 5 points for the story group vs. 6 points for the comparison group, p=0.78). The story group showed significantly greater decision regret regarding their decision to go to the ED (p<0.001): 6.7% of the story group vs. 1.5% of the comparison group strongly disagreed with the statement “I would go for the same choice if I had to do it over again”. The story group reported shorter time to resolution of symptoms (mean 3.7 days story group vs. 4.0 days comparison group, median 3 days both groups; log rank test, p=0.04). No other outcomes were different between study groups. Conclusions Stories about parent experiences managing a child with croup did not reduce parental anxiety. The story group showed significantly greater decision regret and quicker time to resolution of symptoms. Further research is needed to better understand whether stories can be effective in improving patient-important outcomes. Trial Registration Current Controlled

  13. Acupuncture for posttraumatic stress disorder: a randomized controlled pilot trial.

    PubMed

    Hollifield, Michael; Sinclair-Lian, Nityamo; Warner, Teddy D; Hammerschlag, Richard

    2007-06-01

    The purpose of the study was to evaluate the potential efficacy and acceptability of accupuncture for posttraumatic stress disorder (PTSD). People diagnosed with PTSD were randomized to either an empirically developed accupuncture treatment (ACU), a group cognitive-behavioral therapy (CBT), or a wait-list control (WLC). The primary outcome measure was self-reported PTSD symptoms at baseline, end treatment, and 3-month follow-up. Repeated measures MANOVA was used to detect predicted Group X Time effects in both intent-to-treat (ITT) and treatment completion models. Compared with the WLC condition in the ITT model, accupuncture provided large treatment effects for PTSD (F [1, 46] = 12.60; p < 0.01; Cohen's d = 1.29), similar in magnitude to group CBT (F [1, 47] = 12.45; p < 0.01; d = 1.42) (ACU vs. CBT, d = 0.29). Symptom reductions at end treatment were maintained at 3-month follow-up for both interventions. Accupuncture may be an efficacious and acceptable nonexposure treatment option for PTSD. Larger trials with additional controls and methods are warranted to replicate and extend these findings. PMID:17568299

  14. Randomized controlled trials: what are they and who needs them?

    PubMed

    Pihlstrom, Bruce L; Curran, Alice E; Voelker, Helen T; Kingman, Albert

    2012-06-01

    Dentistry is rapidly entering a new era of evidence-based practice, and society is demanding prevention and treatment that has been proven to be effective in terms of meaningful health outcomes. Practitioners, individual patients and the public need randomized controlled trials because they provide the highest level of scientific evidence to change clinical practice and inform public health policy. Well-designed randomized controlled trials are conceptually simple but deceptively complex to design, implement and translate into clinical practice. Randomized controlled trials are fundamentally different from observational clinical research because they randomly assign volunteers to receive test or control interventions, they are prospective and the success of the test intervention is based on a meaningful clinical outcome that is specified before the trial begins. To be successful, randomized controlled trials must be carefully designed and powered to answer a specific question that will be generalizable to the population under study. Randomized controlled trials can be designed to evaluate efficacy, effectiveness, superiority, equivalence or noninferiority. Prominent issues and challenges in designing and conducting randomized controlled trials include carefully defining enrollment criteria, establishing an organizational infrastructure, use of a data-coordinating center, developing a manual of procedures, obtaining informed consent, recruiting and ensuring the safety of volunteer subjects, ensuring data quality, analysis and publication of trial outcomes, and translating results into clinical practice. PMID:22507057

  15. Far from random: dynamical groupings among the NEO population

    NASA Astrophysics Data System (ADS)

    de la Fuente Marcos, C.; de la Fuente Marcos, R.

    2016-03-01

    Among the near-Earth object (NEO) population, there are comets and active asteroids which are sources of fragments that initially move together; in addition, some NEOs follow orbits temporarily trapped in a web of secular resonances. These facts contribute to increasing the risk of meteoroid strikes on Earth, making its proper quantification difficult. The identification and subsequent study of groups of small NEOs that appear to move in similar trajectories are necessary steps in improving our understanding of the impact risk associated with meteoroids. Here, we present results of a search for statistically significant dynamical groupings among the NEO population. Our Monte Carlo-based methodology recovers well-documented groupings like the Taurid Complex or the one resulting from the split comet 73P/Schwassmann-Wachmann 3, and new ones that may have been the source of past impacts. Among the most conspicuous are the Mjolnir and Ptah groups, perhaps the source of recent impact events like Almahata Sitta and Chelyabinsk, respectively. Meteoroid 2014 AA, that hit the Earth on 2014 January 2, could have its origin in a marginally significant grouping associated with Bennu. We find that most of the substructure present within the orbital domain of the NEOs is of resonant nature, probably induced by secular resonances and the Kozai mechanism that confine these objects into specific paths with well-defined perihelia.

  16. A randomized, double-blind, placebo-controlled, multiple-dose, parallel-group clinical trial to assess the effects of teduglutide on gastric emptying of liquids in healthy subjects

    PubMed Central

    2014-01-01

    Background Teduglutide, a recombinant analog of human glucagon-like peptide (GLP)-2, is a novel therapy recently approved for the treatment of adult patients with short bowel syndrome who are dependent on parenteral support. Previous studies assessing the effect of GLP-2 on gastric emptying in humans have yielded inconsistent results, with some studies showing no effect and others documenting a GLP-2–dependent delay in gastric emptying. The primary objective of this study was to assess the effect of teduglutide on gastric emptying of liquids in healthy subjects, as measured by the pharmacokinetics of acetaminophen. Methods This double-blind, parallel-group, single-center study enrolled and randomized 36 healthy subjects (22 men, 14 women) to receive subcutaneous doses of teduglutide 4 mg or placebo (2:1 ratio; 23:13) once daily on Days 1 through 10 in the morning. Gastric emptying of a mixed nutrient liquid meal was assessed by measuring acetaminophen levels predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 3.5, 4, 5, 6, 8, 10, 12, and 14 hours after administration of 1000 mg acetaminophen on Days 0 and 10. The primary study endpoint was a pharmacokinetic analysis of acetaminophen absorption in subjects receiving teduglutide or placebo. Results No significant differences in gastric emptying of liquids (acetaminophen area under the concentration [AUC] vs time curve from time 0 to the last measurable concentration, AUC extrapolated to infinity, maximum concentration [Cmax], and time to Cmax) were observed on Day 10 in subjects receiving teduglutide 4 mg versus subjects receiving placebo. There were no serious adverse events (AEs), deaths, or discontinuations due to an AE reported during the study. Conclusions Teduglutide 4 mg/day for 10 days does not affect gastric emptying of liquids in healthy subjects as measured by acetaminophen pharmacokinetics. No unexpected safety signals were observed. Trial registration This study was registered at Clinical

  17. [Critical of the additive model of the randomized controlled trial].

    PubMed

    Boussageon, Rémy; Gueyffier, François; Bejan-Angoulvant, Theodora; Felden-Dominiak, Géraldine

    2008-01-01

    Randomized, double-blind, placebo-controlled clinical trials are currently the best way to demonstrate the clinical effectiveness of drugs. Its methodology relies on the method of difference (John Stuart Mill), through which the observed difference between two groups (drug vs placebo) can be attributed to the pharmacological effect of the drug being tested. However, this additive model can be questioned in the event of statistical interactions between the pharmacological and the placebo effects. Evidence in different domains has shown that the placebo effect can influence the effect of the active principle. This article evaluates the methodological, clinical and epistemological consequences of this phenomenon. Topics treated include extrapolating results, accounting for heterogeneous results, demonstrating the existence of several factors in the placebo effect, the necessity to take these factors into account for given symptoms or pathologies, as well as the problem of the "specific" effect. PMID:18387273

  18. Coping Mediates Outcome Following a Randomized Group Intervention for HIV-Positive Bereaved Individuals

    PubMed Central

    Smith, Nathan Grant; Tarakeshwar, Nalini; Hansen, Nathan B.; Kochman, Arlene; Sikkema, Kathleen J.

    2013-01-01

    The purpose of this study was to examine the mechanisms responsible for the beneficial psychological effects of a coping-focused group intervention for HIV-positive individuals who had lost loved ones to AIDS. Data from 235 HIV-positive men and women enrolled in a randomized controlled clinical trial testing a coping-focused group intervention were analyzed using a multiple-indicator-multiple-cause (MIMIC) structural equation model. Results revealed that the effects of the intervention on decreases in depression and grief were mediated by decreases in avoidant coping. Specifically, participants in the intervention condition decreased their use of avoidant coping. Decreases in avoidant coping, in turn, were related to decreased depression and grief. The results of this study help to validate the use of coping-focused interventions for HIV-positive bereaved individuals. PMID:19152338

  19. Parent Training with High-Risk Immigrant Chinese Families: A Pilot Group Randomized Trial Yielding Practice-Based Evidence

    ERIC Educational Resources Information Center

    Lau, Anna S.; Fung, Joey J.; Ho, Lorinda Y.; Liu, Lisa L.; Gudino, Omar G.

    2011-01-01

    We studied the efficacy and implementation outcomes of a culturally responsive parent training (PT) program. Fifty-four Chinese American parents participated in a wait-list controlled group randomized trial (32 immediate treatment, 22 delayed treatment) of a 14-week intervention designed to address the needs of high-risk immigrant families.…

  20. Effectiveness of Peer-Led Dissonance-Based Eating Disorder Prevention Groups: Results from Two Randomized Pilot Trials

    PubMed Central

    Rohde, Paul; Durant, Shelley; Shaw, Heather; Wade, Emily

    2014-01-01

    Objective The present preliminary trials tested whether undergraduate peer leaders can effectively deliver a dissonance-based eating disorder prevention program, which could facilitate broad dissemination of this efficacious intervention. Method In Study 1, female undergraduates (N = 171) were randomized to peer-led groups, clinician-led groups, or an educational brochure control condition. In Study 2, which improved a design limitation of Study 1 by using completely parallel outcome measures across conditions, female undergraduates (N = 148) were randomized to either immediate peer-led groups or a waitlist control condition. Results In Study 1, participants in peer- and clinician-led groups showed significantly greater pre-post reductions in risk factors and eating disorder symptoms than controls (M d = .64 and .98 respectively), though clinician- versus peer-led groups had higher attendance and competence rating, and produced stronger effects at posttest (M d = .32) and at 1-year follow-up (M d = .26). In Study 2, participants in peer-led groups showed greater pre-post reductions in all outcomes than waitlist controls (M d = .75). Conclusions Results provide novel evidence that dissonance-based eating disorder prevention groups led by undergraduate peers are feasible and produce greater reductions in eating disorder risk factors and symptoms than minimal-intervention control conditions, but indicate that effects are smaller for peer- versus clinician-led groups. PMID:23419888

  1. Service Learning in Medical and Nursing Training: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leung, A. Y. M.; Chan, S. S. C.; Kwan, C. W.; Cheung, M. K. T.; Leung, S. S. K.; Fong, D. Y. T.

    2012-01-01

    The purpose of this study was to explore the long term effect of a service learning project on medical and nursing students' knowledge in aging and their attitudes toward older adults. A total of 124 students were recruited and then randomized to intervention group (IG) and control group (CG). A pre-and-post-intervention design measured students'…

  2. 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…

  3. Tobacco Cessation Treatment for Alaska Native Adolescents: Group Randomized Pilot Trial

    PubMed Central

    2014-01-01

    Introduction: Tobacco cessation treatments have not been evaluated among Alaska Native (AN) adolescents. This pilot study evaluated the feasibility and the potential efficacy of a targeted cessation intervention for AN youth using a group randomized design. Methods: Eight villages in western Alaska were randomly assigned to receive the intervention (n = 4 villages) or a delayed treatment control condition (written materials only; n = 4 villages). Ten adolescents aged 12–17 years were targeted from each village with a planned enrollment of 80. The intervention was held over a weekend, and youth traveled from their villages to quit tobacco use with other teens. The intervention comprised 8hr of group-based counseling. Talking circles, personal stories from elders, and recreational activities were included to enhance cultural acceptability and participation. Newsletters were mailed weekly for 5-weeks postprogram. Assessments were conducted at baseline, week 6 (end-of-treatment), and 6 months. Self-reported tobacco abstinence was confirmed with salivary cotinine. Results: Recruitment targets were met in the intervention (41 enrolled) but not in control villages (27 enrolled). All intervention participants attended the weekend program. Retention was high; 98% of intervention and 86% of control participants completed 6-month follow-up. The 7-day point-prevalence self-reported tobacco abstinence rates for intervention and control participants were 10% (4/41) and 0% (0/27) at both week 6 and 6 months (p = .15). Only 1 adolescent in the intervention condition was biochemically confirmed abstinent at week 6 and none at 6 months. Conclusion: The intensive individual-focused intervention used in this study was feasible but not effective for tobacco cessation among AN youth. Alternative approaches are warranted. PMID:24532352

  4. Mindfulness meditation in older adults with postherpetic neuralgia: a randomized controlled pilot study

    PubMed Central

    Meize-Grochowski, Robin; Shuster, George; Boursaw, Blake; DuVal, Michelle; Murray-Krezan, Cristina; Schrader, Ron; Smith, Bruce W.; Herman, Carla J.; Prasad, Arti

    2015-01-01

    This parallel-group, randomized controlled pilot study examined daily meditation in a diverse sample of older adults with postherpetic neuralgia. Block randomization was used to allocate participants to a treatment group (n = 13) or control group (n = 14). In addition to usual care, the treatment group practiced daily meditation for six weeks. All participants completed questionnaires at enrollment in the study, two weeks later, and six weeks after that, at the study’s end. Participants recorded daily pain and fatigue levels in a diary, and treatment participants also noted meditation practice. Results at the .10 level indicated improvement in neuropathic, affective, and total pain scores for the treatment group, whereas affective pain worsened for the control group. Participants were able to adhere to the daily diary and meditation requirements in this feasibility pilot study. PMID:25784079

  5. Mindfulness meditation in older adults with postherpetic neuralgia: a randomized controlled pilot study.

    PubMed

    Meize-Grochowski, Robin; Shuster, George; Boursaw, Blake; DuVal, Michelle; Murray-Krezan, Cristina; Schrader, Ron; Smith, Bruce W; Herman, Carla J; Prasad, Arti

    2015-01-01

    This parallel-group, randomized controlled pilot study examined daily meditation in a diverse sample of older adults with postherpetic neuralgia. Block randomization was used to allocate participants to a treatment group (n = 13) or control group (n = 14). In addition to usual care, the treatment group practiced daily meditation for six weeks. All participants completed questionnaires at enrollment in the study, two weeks later, and six weeks after that, at the study's end. Participants recorded daily pain and fatigue levels in a diary, and treatment participants also noted meditation practice. Results at the 0.10 level indicated improvement in neuropathic, affective, and total pain scores for the treatment group, whereas affective pain worsened for the control group. Participants were able to adhere to the daily diary and meditation requirements in this feasibility pilot study. PMID:25784079

  6. Control of complex physically simulated robot groups

    NASA Astrophysics Data System (ADS)

    Brogan, David C.

    2001-10-01

    Actuated systems such as robots take many forms and sizes but each requires solving the difficult task of utilizing available control inputs to accomplish desired system performance. Coordinated groups of robots provide the opportunity to accomplish more complex tasks, to adapt to changing environmental conditions, and to survive individual failures. Similarly, groups of simulated robots, represented as graphical characters, can test the design of experimental scenarios and provide autonomous interactive counterparts for video games. The complexity of writing control algorithms for these groups currently hinders their use. A combination of biologically inspired heuristics, search strategies, and optimization techniques serve to reduce the complexity of controlling these real and simulated characters and to provide computationally feasible solutions.

  7. Building Kindergartners' Number Sense: A Randomized Controlled Study

    ERIC Educational Resources Information Center

    Jordan, Nancy C.; Glutting, Joseph; Dyson, Nancy; Hassinger-Das, Brenna; Irwin, Casey

    2012-01-01

    Math achievement in elementary school is mediated by performance and growth in number sense during kindergarten. The aim of the present study was to test the effectiveness of a targeted small-group number sense intervention for high-risk kindergartners from low-income communities. Children were randomly assigned to 1 of 3 groups (n = 44 in each…

  8. Couples groups for parents of preschoolers: ten-year outcomes of a randomized trial*

    PubMed Central

    Cowan, Carolyn Pape; Cowan, Philip A.; Barry, Jason

    2011-01-01

    This paper reports the results of a 10-year follow-up of two variations of a couples group preventive intervention offered to couples in the year before their oldest child made the transition to kindergarten. 100 couples were randomly assigned to (1) a low-dose control condition, (2) a couples group meeting for 16 weeks that focused more on couple relationship issues among other family topics, or (3) a couples group meeting for 16 weeks that focused more on parenting issues among other family issues, with an identical curriculum to condition (2). Earlier papers reported that both variations of the intervention produced positive results on parent-child relationships and on the children’s adaptation to kindergarten and 1st grade, and that the groups emphasizing couple relationships also had additional positive effects on couple interaction quality. The present paper uses growth curve analyses to examine intervention effects extending from the children’s transition to kindergarten to the transition to high school – ten years after the couples groups ended. There were 6-year positive effects of the pre-kindergarten interventions on observed couple interaction and 10-year positive effects on both parents’ marital satisfaction and the children’s adaptation (hyperactivity and aggression). Discussion includes a focus on the implications of these results for family policy, clinical practice, and the need to include a couples focus in preventive interventions to strengthen family relationships and enhance children’s adaptation to school. PMID:21480703

  9. History of the Athens Canadian Random Bred and the Athens Random Bred control populations.

    PubMed

    Collins, K E; Marks, H L; Aggrey, S E; Lacy, M P; Wilson, J L

    2016-05-01

    The University of Georgia maintains two meat-type chicken control strains: the Athens Random Bred (ARB) and the Athens Canadian Random Bred (ACRB). The Athens Random Bred was developed from colored plumage commercial meat chicken strains in 1956. The ACRB is a replicate population of the Ottawa Meat Control strain which was developed in 1955 from white plumage commercial meat-type chickens. These genetic lines have been extremely valuable research resources and have been used extensively to provide comparative context to modern meat-type strains. The ACRB may be the oldest pedigreed control commercial meat-type chicken still in existence today. This paper reviews the history of the breed backgrounds for both control populations and reviews research utilizing the ACRB. PMID:26976904

  10. A Randomized Controlled Trial of Hanen's "More than Words" in Toddlers with Early Autism Symptoms

    ERIC Educational Resources Information Center

    Carter, Alice S.; Messinger, Daniel S.; Stone, Wendy L.; Celimli, Seniz; Nahmias, Allison S.; Yoder, Paul

    2011-01-01

    Background: This randomized controlled trial compared Hanen's "More than Words" (HMTW), a parent-implemented intervention, to a "business as usual" control group. Methods: Sixty-two children (51 boys and 11 girls; M age = 20 months; SD = 2.6) who met criteria for autism spectrum disorders (ASD) and their parents participated in the study. The HMTW…

  11. Parent Training for Young Children with Developmental Disabilities: Randomized Controlled Trial

    ERIC Educational Resources Information Center

    McIntyre, Laura Lee

    2008-01-01

    A randomized controlled trial was used to evaluate a parent training intervention for caregivers with preschool-age children with developmental disabilities. The 21 families in the experimental group received usual care plus the 12-week Incredible Years Parent Training Program with developmental delay modifications. Families in the control group…

  12. Effectiveness of "Primary Bereavement Care" for Widows: A Cluster Randomized Controlled Trial Involving Family Physicians

    ERIC Educational Resources Information Center

    García, Jesus A.; Landa, Victor; Grandes, Gonzalo; Pombo, Haizea; Mauriz, Amaia

    2013-01-01

    Thirty-one family physicians, from 19 primary care teams in Biscay (Spain), were randomly assigned to intervention or control group. The 15 intervention family physicians, after training in primary bereavement care, saw 43 widows for 7 sessions, from the 4th to 13th month after their loss. The 16 control family physicians, without primary…

  13. Qigong and fibromyalgia: randomized controlled trials and beyond.

    PubMed

    Sawynok, Jana; Lynch, Mary

    2014-01-01

    Introduction. Qigong is currently considered as meditative movement, mindful exercise, or complementary exercise and is being explored for relief of symptoms in fibromyalgia. Aim. This narrative review summarizes randomized controlled trials, as well as additional studies, of qigong published to the end of 2013 and discusses relevant methodological issues. Results. Controlled trials indicate regular qigong practice (daily, 6-8 weeks) produces improvements in core domains for fibromyalgia (pain, sleep, impact, and physical and mental function) that are maintained at 4-6 months compared to wait-list subjects or baselines. Comparisons with active controls show little difference, but compared to baseline there are significant and comparable effects in both groups. Open-label studies provide information that supports benefit but remain exploratory. An extension trial and case studies involving extended practice (daily, 6-12 months) indicate marked benefits but are limited by the number of participants. Benefit appears to be related to amount of practice. Conclusions. There is considerable potential for qigong to be a useful complementary practice for the management of fibromyalgia. However, there are unique methodological challenges, and exploration of its clinical potential will need to focus on pragmatic issues and consider a spectrum of trial designs. Mechanistic considerations need to consider both system-wide and more specific effects. PMID:25477991

  14. Random and Targeted Interventions for Epidemic Control in Metapopulation Models

    NASA Astrophysics Data System (ADS)

    Tanaka, Gouhei; Urabe, Chiyori; Aihara, Kazuyuki

    2014-07-01

    In general, different countries and communities respond to epidemics in accordance with their own control plans and protocols. However, owing to global human migration and mobility, strategic planning for epidemic control measures through the collaboration of relevant public health administrations is gaining importance for mitigating and containing large-scale epidemics. Here, we present a framework to evaluate the effectiveness of random (non-strategic) and targeted (strategic) epidemic interventions for spatially separated patches in metapopulation models. For a random intervention, we analytically derive the critical fraction of patches that receive epidemic interventions, above which epidemics are successfully contained. The analysis shows that the heterogeneity of patch connectivity makes it difficult to contain epidemics under the random intervention. We demonstrate that, particularly in such heterogeneously connected networks, targeted interventions are considerably effective compared to the random intervention. Our framework is useful for identifying the target areas where epidemic control measures should be focused.

  15. Can Group Interventions Facilitate Forgiveness of an Ex-Spouse?: A Randomized Clinical Trial

    ERIC Educational Resources Information Center

    Rye, Mark S.; Pargament, Kenneth I.; Pan, Wei; Yingling, David W.; Shogren, Karrie A.; Ito, Masako

    2005-01-01

    This study evaluated the effectiveness of 2 versions of an 8-session forgiveness group intervention for divorced individuals. Participants (randomized, n = 192; analyzed, n = 149) were randomly assigned to a secular forgiveness condition, a religious forgiveness condition, or a no-intervention comparison condition. Measures of forgiveness and…

  16. Intraclass Correlation Values for Planning Group-Randomized Trials in Education

    ERIC Educational Resources Information Center

    Hedges, Larry V.; Hedberg, E. C.

    2007-01-01

    Experiments that assign intact groups to treatment conditions are increasingly common in social research. In educational research, the groups assigned are often schools. The design of group-randomized experiments requires knowledge of the intraclass correlation structure to compute statistical power and sample sizes required to achieve adequate…

  17. 78 FR 46851 - Controlled Group Regulation Examples

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

    ... controlled group rules should be applied in connection with the RIC ``asset diversification'' test. This...)(B) provides that, to qualify as a RIC, a taxpayer must meet an asset diversification test pursuant... the asset diversification test has been met, the proportion of any investment in the securities...

  18. In their own voices: Latinas' experiences with a randomized controlled trial.

    PubMed

    Le, Huynh-Nhu; Perry, Deborah F; Genovez, Marta; Cardeli, Emma

    2013-06-01

    We conducted exit interviews with a random sample of 39 predominantly Central American immigrant mothers who had completed a longitudinal randomized controlled trial to prevent perinatal depression. We found that rates and levels of perinatal depression in the intervention and control groups were lower than expected and did not differ between groups at 1 year postpartum. Therefore, we conducted extensive semistructured interviews to (a) understand why these high-risk women had such low rates of major depressive episodes and depressive symptoms, and (b) determine if the mechanisms responsible for reductions in depression differed between the intervention and usual care groups. We discovered that the intervention group learned specific mood-management skills from their participation in the intervention, and that the control group experienced their participation in the study as a "low-dose" intervention. Our experience highlights the importance of conducting qualitative studies to understand quantitative outcomes of intervention studies. PMID:23539092

  19. Laser acupuncture for adolescent smokers--a randomized double-blind controlled trial.

    PubMed

    Yiming, C; Changxin, Z; Ung, W S; Lei, Z; Kean, L S

    2000-01-01

    A double blind, randomized, placebo-controlled clinical study was conducted to evaluate the efficacy of laser acupuncture treatment in adolescent smokers. Three hundred and thirty adolescent smokers at the Smoking Cessation Clinic of Child Guidance Clinic, Institute of Health, Singapore, were randomly assigned in equal numbers to laser acupuncture treatment and sham acupuncture (control) groups. The proportions of patients with complete smoking cessation after completing treatment for four weeks were 21.9% in the treatment group and 21.4% in the control group. At three months post-treatment, the rates for complete cessation were 24.8% and 26.2%, respectively. Thus, there was no significant difference in the rates of smoking cessation in the treatment and control groups. PMID:11154059

  20. Effects of zinc supplementation on subscales of anorexia in children: A randomized controlled trial

    PubMed Central

    Khademian, Majid; Farhangpajouh, Neda; Shahsanaee, Armindokht; Bahreynian, Maryam; Mirshamsi, Mehran; Kelishadi, Roya

    2014-01-01

    Objectives: This study aims to assess the effects of zinc supplementation on improving the appetite and its subscales in children. Methods: This study was conducted in 2013 in Isfahan, Iran. It had two phases. At the first step, after validation of the Child Eating Behaviour Questionaire (CEBQ), it was completed for 300 preschool children, who were randomly selected. The second phase was conducted as a randomized controlled trial. Eighty of these children were randomly selected, and were randomly assigned to two groups of equal number receiving zinc (10 mg/day) or placebo for 12 weeks. Results: Overall 77 children completed the trial (39 in the case and 3 in the control group).The results showed that zinc supplement can improve calorie intake in children by affecting some CEBQ subscales like Emotional over Eating and Food Responsible. Conclusion: Zinc supplementation had positive impact in promoting the calorie intake and some subscales of anorexia. PMID:25674110

  1. Amoxicillin for acute rhinosinusitis: A randomized controlled trial

    PubMed Central

    Garbutt, Jane M.; Banister, Christina; Spitznagel, Edward; Piccirillo, Jay F.

    2013-01-01

    Context Evidence to support antibiotic treatment for acute rhinosinusitis is scant, yet antibiotics are commonly used. Objective To determine the incremental effect of amoxicillin treatment over symptomatic treatments for adults with clinically diagnosed acute rhinosinusitis. Design Randomized placebo-controlled trial Participants and Setting Adults with uncomplicated, acute rhinosinusitis were recruited from 10 community practices in Missouri between November 1st 2006 and May 1st 2009 Interventions Ten-day course of either amoxicillin (1500mg/day) or placebo administered in three doses/day. All patients received a 5-7-day supply of symptomatic treatments for pain, fever, cough and nasal congestion to use as needed. Main Outcome Measures The primary outcome was improvement in the disease-specific quality of life after 3–4 days of treatment assessed with the SNOT-16 (minimally important difference 0.5 on 0 to 3 scale). Secondary outcomes included the patients' retrospective assessment of change in sinus symptoms and functional status, recurrence or relapse, satisfaction with and adverse effects of treatment. Outcomes were assessed by telephone interview at Days 3, 7, 10 and 28. Results 166 adults (36% male, 78% Caucasian) were randomized to amoxicillin (85) or placebo (81); 92% concurrently used ≥1 symptomatic treatment (amoxicillin, 94%, placebo 90%, p=0.34). The mean change in SNOT-16 scores was not significantly different between groups on Day 3 (mean difference between groups 0.03, 95% CI −0.12 to 0.19) and Day 10, but differed at Day 7 favoring amoxicillin (mean difference between groups 0.19, 95% CI 0.024 to 0.35). At Day 7 more participants treated with amoxicillin reported symptom improvement (74% vs. 56%, p=0.0205; NNT = 6, 95% CI 3 to 34), with no difference at Day-3 or Day-10. No between group differences were found for any other secondary outcomes. No serious adverse events occurred. Conclusion Among patients with acute rhinosinusitis, a 10-day

  2. CoCo trial: Color-coded blood pressure Control, a randomized controlled study

    PubMed Central

    Chmiel, Corinne; Senn, Oliver; Rosemann, Thomas; Del Prete, Valerio; Steurer-Stey, Claudia

    2014-01-01

    Background Inadequate blood pressure (BP) control is a frequent challenge in general practice. The objective of this study was to determine whether a color-coded BP booklet using a traffic light scheme (red, >180 mmHg systolic BP and/or >110 mmHg diastolic BP; yellow, >140–180 mmHg systolic BP or >90–110 mmHg diastolic BP; green, ≤140 mmHg systolic BP and ≤90 mmHg diastolic BP) improves BP control and adherence with home BP measurement. Methods In this two-group, randomized controlled trial, general practitioners recruited adult patients with a BP >140 mmHg systolic and/or >90 mmHg diastolic. Patients in the control group received a standard BP booklet and the intervention group used a color-coded booklet for daily home BP measurement. The main outcomes were changes in BP, BP control (treatment goal <140/90 mmHg), and adherence with home BP measurement after 6 months. Results One hundred and twenty-one of 137 included patients qualified for analysis. After 6 months, a significant decrease in systolic and diastolic BP was achieved in both groups, with no significant difference between the groups (16.1/7.9 mmHg in the intervention group versus 13.1/8.6 mmHg in the control group, P=0.3/0.7). BP control (treatment target <140/90 mmHg) was achieved significantly more often in the intervention group (43% versus 25%; P=0.037; number needed to treat of 5). Adherence with home BP measurement overall was high, with a trend in favor of the intervention group (98.6% versus 96.2%; P=0.1) Conclusion Color-coded BP self-monitoring significantly improved BP control (number needed to treat of 5, meaning that every fifth patient utilizing color-coded self-monitoring achieved better BP control after 6 months), but no significant between-group difference was observed in BP change. A markedly higher percentage of patients achieved BP values in the normal range. This simple, inexpensive approach of color-coded BP self-monitoring is user-friendly and applicable in primary care

  3. Multiple input/output random vibration control system

    NASA Technical Reports Server (NTRS)

    Unruh, James F.

    1988-01-01

    A multi-input/output random vibration control algorithm was developed based on system identification concepts derived from random vibration spectral analysis theory. The unique features of the algorithm are: (1) the number of input excitors and the number of output control responses need not be identical; (2) the system inverse response matrix is obtained directly from the input/output spectral matrix; and (3) the system inverse response matrix is updated every control loop cycle to accommodate system amplitude nonlinearities. A laboratory demonstration case of two imputs with three outputs is presented to demonstrate the system capabilities.

  4. The Use of Control in Non-Randomized Designs.

    ERIC Educational Resources Information Center

    Halperin, Si; Jorgensen, Randall

    The concept of control is fundamental to comparative research. In research designs where randomization of observational units is not possible, control has been exercised statistically from a single covariate by a process of residualization. The alternative, known as subclassification on the propensity score, was developed primarily for…

  5. Gabapentin Treatment for Alcohol Dependence: A Randomized Controlled Trial

    PubMed Central

    Mason, Barbara J.; Quello, Susan; Goodell, Vivian; Shadan, Farhad; Kyle, Mark; Begovic, Adnan

    2013-01-01

    Importance Approved medications for alcohol dependence are prescribed for fewer than 9% of US alcoholics. Objective To determine if gabapentin, a widely-prescribed generic calcium channel/GABA modulating medication, increases rates of sustained abstinence and no heavy drinking, and decreases alcohol-related insomnia, dysphoria and craving, in a dose-dependent manner. Design, Participants and Setting A 12-week, double-blind, placebo-controlled, randomized dose-ranging trial of 150 men and women over 18 years of age with current alcohol dependence, conducted 2004–2010 at a single-site outpatient clinical research facility adjoining a general medical hospital. Interventions Oral gabapentin (0, 900, 1800 mg/d) and concomitant manual-guided counseling. Main Outcome Measures Rates of complete abstinence and no heavy drinking (co-primary) and changes in mood, sleep and craving (secondary) over the 12-week study. Results Gabapentin significantly improved the rates of abstinence and no heavy drinking. The abstinence rate was 4.1% (95% CI, 1.1 to 13.7) in the placebo group, 11.1% (95% CI, 5.2 to 22.2) in the 900 mg group, and 17.0% (95% CI, 8.9 to 30.1) in the 1800 mg group (p = 0.04 for linear dose effect, NNT = 8 for 1800 mg). The no heavy drinking rate was 22.5% (95% CI, 13.6 to 37.2) in the placebo group, 29.6% (95% CI, 19.1 to 42.8) in the 900 mg group, and 44.7% (95% CI, 31.4 to 58.8) in the 1800 mg group (p = 0.02 for linear dose effect, NNT = 5 for 1800 mg). Similar linear dose effects were obtained with measures of mood (F=7.37, df=2, p=0.001), sleep (F=136, df=2, p<0.001), and craving (F=3.56, df=2, p=0.029). There were no serious drug-related adverse events, and terminations from adverse-events (9 of 150 participants), time on study (9.1 [3.8] weeks) and rate of study completion (85 of 150 participants) did not differ between groups. Conclusions and Relevance Gabapentin (particularly the 1800 mg dosage) was effective in treating alcohol dependence and relapse

  6. A Randomized Controlled Trial Evaluation of an After-School Prosocial Behavior Program in an Area of Socioeconomic Disadvantage

    ERIC Educational Resources Information Center

    O'Hare, Liam; Biggart, Andy; Kerr, Karen; Connolly, Paul

    2015-01-01

    A randomized controlled trial was used to evaluate the effects of a prosocial behavior after-school program called Mate-Tricks for 9- and 10-year-old children and their parents living in an area of significant socioeconomic disadvantage. The children were randomly assigned to an intervention (n = 220) or a control group (n = 198). Children were…

  7. COMPARISON OF ONCE-DAILY VERSUS TWICE-DAILY COMBINATION ANTIRETROVIRAL THERAPY IN TREATMENT-NAÏVE PATIENTS: RESULTS OF AIDS CLINICAL TRIALS GROUP (ACTG) A5073, A 48-WEEK RANDOMIZED CONTROLLED TRIAL

    PubMed Central

    Flexner, Charles; Tierney, Camlin; Gross, Robert; Andrade, Adriana; Lalama, Christina; Eshleman, Susan H.; Aberg, Judith; Sanne, Ian; Parsons, Teresa; Kashuba, Angela; Rosenkranz, Susan L.; Kmack, Anne; Ferguson, Elaine; Dehlinger, Marjorie; Mildvan, Donna

    2010-01-01

    Background Dosing frequency is an important determinant of regimen effectiveness. Methods To compare efficacy of once-daily (QD) versus twice-daily (BID) antiretroviral therapy, we randomized HIV-1 positive, treatment-naïve, patients to lopinavir/ritonavir (LPV/r) 400/100 mg BID (n=160) or LPV/r 800/200 mg QD (n=161), plus either emtricitabine 200 mg QD and extended-release stavudine (d4T-XR) 100 mg QD, or tenofovir 300 mg QD. Randomization was stratified by screening HIV-1 RNA

  8. Randomized controlled trial of atorvastatin in clinically isolated syndrome

    PubMed Central

    Waubant, E.; Pelletier, D.; Mass, M.; Cohen, J.A.; Kita, M.; Cross, A.; Bar-Or, A.; Vollmer, T.; Racke, M.; Stüve, O.; Schwid, S.; Goodman, A.; Kachuck, N.; Preiningerova, J.; Weinstock-Guttman, B.; Calabresi, P.A.; Miller, A.; Mokhtarani, M.; Iklé, D.; Murphy, S.; Kopetskie, H.; Ding, L.; Rosenberg, E.; Spencer, C.; Zamvil, S.S.; Waubant, E.; Pelletier, D.; Mass, M.; Bourdette, D.; Egan, R.; Cohen, J.; Stone, L.; Kita, M.; Elliott, M.; Cross, A.; Parks, B.J.; Bar-Or, A.; Vollmer, T.; Campagnolo, D.; Racke, M.; Stüve, O.; Frohman, E.; Schwid, S.; Goodman, A.; Segal, B.; Kachuck, N.; Weiner, L.; Preiningerova, J.; Carrithers, M.; Weinstock-Guttman, B.; Calabresi, P.; Kerr, D.; Miller, A.; Lublin, F.; Sayre, Peter; Hayes, Deborah; Rosenberg, Ellen; Gao, Wendy; Ding, Linna; Adah, Steven; Mokhtarani, Masoud; Neuenburg, Jutta; Bromstead, Carolyn; Olinger, Lynn; Mullen, Blair; Jamison, Ross; Speth, Kelly; Saljooqi, Kerensa; Phan, Peter; Phippard, Deborah; Seyfert-Margolis, Vicki; Bourcier, Katarzyna; Debnam, Tracia; Romaine, Jennifer; Wolin, Stephanie; O'Dale, Brittany; Iklé, David; Murphy, Stacey; Kopetskie, Heather

    2012-01-01

    Objective: To test efficacy and safety of atorvastatin in subjects with clinically isolated syndrome (CIS). Methods: Subjects with CIS were enrolled in a phase II, double-blind, placebo-controlled, 14-center randomized trial testing 80 mg atorvastatin on clinical and brain MRI activity. Brain MRIs were performed quarterly. The primary endpoint (PEP) was development of ≥3 new T2 lesions, or one clinical relapse within 12 months. Subjects meeting the PEP were offered additional weekly interferon β-1a (IFNβ-1a). Results: Due to slow recruitment, enrollment was discontinued after 81 of 152 planned subjects with CIS were randomized and initiated study drug. Median (interquartile range) numbers of T2 and gadolinium-enhancing (Gd) lesions were 15.0 (22.0) and 0.0 (0.0) at baseline. A total of 53.1% of atorvastatin recipients (n = 26/49) met PEP compared to 56.3% of placebo recipients (n = 18/32) (p = 0.82). Eleven atorvastatin subjects (22.4%) and 7 placebo subjects (21.9%) met the PEP by clinical criteria. Proportion of subjects who did not develop new T2 lesions up to month 12 or to starting IFNβ-1a was 55.3% in the atorvastatin and 27.6% in the placebo group (p = 0.03). Likelihood of remaining free of new T2 lesions was significantly greater in the atorvastatin group compared with placebo (odds ratio [OR] = 4.34, p = 0.01). Likelihood of remaining free of Gd lesions tended to be higher in the atorvastatin group (OR = 2.72, p = 0.11). Overall, atorvastatin was well tolerated. No clear antagonistic effect of atorvastatin plus IFNβ-1a was observed on MRI measures. Conclusion: Atorvastatin treatment significantly decreased development of new brain MRI T2 lesion activity, although it did not achieve the composite clinical and imaging PEP. Classification of Evidence: This study provided Class II evidence that atorvastatin did not reduce the proportion of patients with CIS meeting imaging and clinical criteria for starting immunomodulating therapy after 12 months

  9. Interference control training for PTSD: A randomized controlled trial of a novel computer-based intervention.

    PubMed

    Bomyea, Jessica; Stein, Murray B; Lang, Ariel J

    2015-08-01

    Post-traumatic stress disorder (PTSD) is a chronic and debilitating condition characterized by persistent intrusive memories. Although effective treatments exist for PTSD, there is a need for development of alternative treatments. Diminished ability to control proactive interference may contribute to re-experiencing symptoms and may be a novel intervention target. The present study tested an intervention designed to modify proactive interference control clinicaltrials.gov identifier: (NCT02139137). Forty-two women with PTSD were randomly assigned to a computerized cognitive training or a control condition. The impact of these programs on cognitive performance and symptoms was assessed. PTSD re-experiencing symptoms and interference control performance improved significantly more for individuals in the training group relative to those in the control group. Other PTSD and general distress symptoms improved equally over time in both groups. Cognitive training of this type may hold promise as a novel intervention for reducing PTSD symptoms, although the mechanism of action and implications for models of PTSD requires future study. PMID:26114901

  10. Tryptophan Supplementation and Postoperative Delirium – A Randomized Controlled Trial

    PubMed Central

    Robinson, Thomas N.; Dunn, Christina L.; Adams, Jill C.; Hawkins, Carrie L.; Tran, Zung V.; Raeburn, Christopher D.; Moss, Marc

    2014-01-01

    Background/Objectives Tryptophan deficiency has been associated with increased incidence of postoperative delirium. Therefore, we hypothesized that the post-operative administration of tryptophan would be beneficial for elderly surgical patients who are at higher risk of developing post-operative delirium. Design Randomized, double-blind, placebo controlled trial. Setting: Participants A total of 325 individuals aged 60 years and older undergoing major elective operations requiring a postoperative intensive care unit admission. Intervention L-tryptophan, 1 gram orally, three times daily or placebo was started following the operation and continued for up to three days postoperatively. Measurements Delirium and its motor subtypes were measured using the Confusion Assessment Method-ICU and the Richmond Agitation and Sedation Scale. The primary outcome for between groups comparison was the incidence of excitatory (mixed and hyperactive) postoperative delirium. The secondary outcomes for comparison were the incidence and duration of overall postoperative delirium. Results The overall incidence of postoperative delirium was 39% (116) (95% confidence interval 34% to 44%). The percentages of patients with excitatory delirium in the tryptophan and placebo groups were 17% and 9% (p=0.176), and the duration of excitatory delirium was 3.3±1.7 and 3.1±1.9 days (p=0.741). The percentage of patients with overall delirium in the tryptophan and placebo groups was 40% and 37% (p=0.597), and the duration of overall delirium was 2.9±1.8 and 2.4±1.6 days (p=0.167). Conclusion Postoperative tryptophan supplementation in older adults undergoing major elective operations requiring postoperative intensive care unit admission demonstrated no efficacy in reducing the incidence of postoperative excitatory delirium or overall delirium, and the duration of excitatory or overall delirium. PMID:25112175

  11. Acupuncture as a treatment for functional dyspepsia: design and methods of a randomized controlled trial

    PubMed Central

    Zheng, Hui; Tian, Xiao-ping; Li, Ying; Liang, Fan-rong; Yu, Shu-guang; Liu, Xu-guang; Tang, Yong; Yang, Xu-guang; Yan, Jie; Sun, Guo-jie; Chang, Xiao-rong; Zhang, Hong-xing; Ma, Ting-ting; Yu, Shu-yuan

    2009-01-01

    Background Acupuncture is widely used in China to treat functional dyspepsia (FD). However, its effectiveness in the treatment of FD, and whether FD-specific acupoints exist, are controversial. So this study aims to determine if acupuncture is an effective treatment for FD and if acupoint specificity exists according to traditional acupuncture meridians and acupoint theories. Design This multicenter randomized controlled trial will include four acupoint treatment groups, one non-acupoint control group and one drug (positive control) group. The four acupoint treatment groups will focus on: (1) specific acupoints of the stomach meridian; (2) non-specific acupoints of the stomach meridian; (3) specific acupoints of alarm and transport points; and (4) acupoints of the gallbladder meridian. These four groups of acupoints are thought to differ in terms of clinical efficacy, according to traditional acupuncture meridians and acupoint theories. A total of 120 FD patients will be included in each group. Each patient will receive 20 sessions of acupuncture treatment over 4 weeks. The trial will be conducted in eight hospitals located in three centers of China. The primary outcomes in this trial will include differences in Nepean Dyspepsia Index scores and differences in the Symptom Index of Dyspepsia before randomization, 2 weeks and 4 weeks after randomization, and 1 month and 3 months after completing treatment. Discussion The important features of this trial include the randomization procedures (controlled by a central randomization system), a standardized protocol of acupuncture manipulation, and the fact that this is the first multicenter randomized trial of FD and acupuncture to be performed in China. The results of this trial will determine whether acupuncture is an effective treatment for FD and whether using different acupoints or different meridians leads to differences in clinical efficacy. Trial registration number Clinical Trials.gov Identifier: NCT00599677

  12. Acupoint Stimulation on Weight Reduction for Obesity: A Randomized Sham-Controlled Study.

    PubMed

    Yeh, Mei-Ling; Chu, Nain-Feng; Hsu, Man-Ying F; Hsu, Chin-Che; Chung, Yu-Chu

    2015-12-01

    Auricular acupoint stimulation has become a popular weight loss method. However, its efficacy for obesity treatment has not been fully studied. This study aimed to investigate the effect of a 10-week intervention of auricular electrical stimulation combined with auricular acupressure on weight reduction in obese outpatients. In this single-blind randomized sham-controlled study, 134 participants were randomly assigned to an experimental group receiving stimulation at true acupoints, or a sham group receiving stimulation delivered in the same manner but at sham acupoints. Each participant received nutrition counseling by a nutritionist weekly. The results showed significant differences in body mass index, blood pressure, total cholesterol, triglyceride, and leptin or adiponectin over time within the group, but not between the groups. This study could not exclude the effect of placebo and dietary consultation. Further study that adds a control group receiving no treatment is therefore needed to confirm the effects of auricular acupressure. PMID:25183702

  13. Weight Control Intervention for Truck Drivers: The SHIFT Randomized Controlled Trial, United States

    PubMed Central

    Wipfli, Brad; Thompson, Sharon V.; Elliot, Diane L.; Anger, W. Kent; Bodner, Todd; Hammer, Leslie B.; Perrin, Nancy A.

    2016-01-01

    Objectives. To evaluate the effectiveness of the Safety and Health Involvement For Truckers (SHIFT) intervention with a randomized controlled design. Methods. The multicomponent intervention was a weight-loss competition supported with body weight and behavioral self-monitoring, computer-based training, and motivational interviewing. We evaluated intervention effectiveness with a cluster-randomized design involving 22 terminals from 5 companies in the United States in 2012 to 2014. Companies were required to provide interstate transportation services and operate at least 2 larger terminals. We randomly assigned terminals to intervention or usual practice control conditions. We assessed participating drivers (n = 452) at baseline and 6 months. Results. In an intent-to-treat analysis, the postintervention difference between groups in mean body mass index change was 1.00 kilograms per meters squared (P < .001; intervention = −0.73; control = +0.27). Behavioral changes included statistically significant improvements in fruit and vegetable consumption and physical activity. Conclusions. Results establish the effectiveness of a multicomponent and remotely administered intervention for producing significant weight loss among commercial truck drivers. PMID:27463067

  14. Randomized Controlled Trials for the Treatment of Hidradenitis Suppurativa.

    PubMed

    van Rappard, Dominique C; Mekkes, Jan R; Tzellos, Thrasivoulos

    2016-01-01

    Hidradenitis suppurativa (HS) is a chronic, inflammatory, recurrent, debilitating skin disease. Several treatment modalities are available, but most of them lack high-quality evidence. A systematic search was performed to identify all randomized controlled trials for the treatment of HS in order to review and evaluate the evidence. Recommendations for future randomized controlled trials include using validated scores, inclusion of patient rated outcomes, and thorough report of side effects. Evidence for long-term treatment and benefit/risk ratio of available treatment modalities is needed in order to enhance evidence-based treatment in daily clinical practice. Combining surgery with antiinflammatory treatment warrants further investigation. PMID:26617360

  15. Efficacy and safety of monotherapy with the novel sodium/glucose cotransporter-2 inhibitor tofogliflozin in Japanese patients with type 2 diabetes mellitus: a combined Phase 2 and 3 randomized, placebo-controlled, double-blind, parallel-group comparative study

    PubMed Central

    2014-01-01

    Background In recent years, several oral antidiabetic drugs with new mechanisms of action have become available, expanding the number of treatment options. Sodium/glucose cotransporter-2 (SGLT2) inhibitors are a new class of oral antidiabetic drugs with an insulin-independent mechanism promoting urinary glucose excretion. We report the results of a combined Phase 2 and 3 clinical study (Japic CTI-101349) of the SGLT2 inhibitor tofogliflozin (CSG452, RG7201) in Japanese patients with type 2 diabetes mellitus. Methods The efficacy and safety of tofogliflozin were assessed in this multicenter, placebo-controlled, randomized, double-blind parallel-group study involving 230 patients with type 2 diabetes mellitus with inadequate glycemic control on diet/exercise therapy. Between 30 October 2010 and 28 February 2012, patients at 33 centers were randomized to either placebo (n = 56) or tofogliflozin (10, 20, or 40 mg; n = 58 each) orally, once daily for 24 weeks. The primary efficacy endpoint was the change from baseline in HbA1c at week 24. Results Overall, 229 patients were included in the full analysis set (placebo: n = 56; tofogliflozin 10 mg: n = 57; tofogliflozin 20 and 40 mg: n = 58 each). The least squares (LS) mean change (95% confidence interval) from baseline in HbA1c at week 24 was −0.028% (−0.192 to 0.137) in the placebo group, compared with −0.797% (−0.960 to −0.634) in the tofogliflozin 10 mg group, −1.017% (−1.178 to −0.856) in the tofogliflozin 20 mg group, and −0.870% (−1.031 to −0.709) in the tofogliflozin 40 mg group (p < 0.0001 for the LS mean differences in all tofogliflozin groups vs placebo). There were also prominent decreases in fasting blood glucose, 2-h postprandial glucose, and body weight in all tofogliflozin groups compared with the placebo group. The main adverse events were hyperketonemia, ketonuria, and pollakiuria. The incidence of hypoglycemia was low. Furthermore, most adverse events were

  16. The Implications of Teacher Selection and Teacher Effects in Individually Randomized Group Treatment Trials

    ERIC Educational Resources Information Center

    Weiss, Michael J.

    2010-01-01

    Randomized experiments have become an increasingly popular design to evaluate the effectiveness of interventions in education (Spybrook, 2008). Many of the interventions evaluated in education are delivered to groups of students, rather than to individuals. Experiments designed to evaluate programs delivered at the group level often…

  17. Assigning Students in Group Work Projects. Can We Do Better than Random?

    ERIC Educational Resources Information Center

    Huxham, Mark; Land, Ray

    2000-01-01

    Discussion of group work projects in higher education focuses on a comparison of the performance of student groups formed randomly, with those formed using the Honey and Mumford learning styles questionnaire. Describes results that indicate no significant difference in student performances and considers the relationship to the Kolb model.…

  18. Virtual reality robotic surgery simulation curriculum to teach robotic suturing: a randomized controlled trial.

    PubMed

    Kiely, Daniel J; Gotlieb, Walter H; Lau, Susie; Zeng, Xing; Samouelian, Vanessa; Ramanakumar, Agnihotram V; Zakrzewski, Helena; Brin, Sonya; Fraser, Shannon A; Korsieporn, Pira; Drudi, Laura; Press, Joshua Z

    2015-09-01

    The objective of this randomized, controlled trial was to assess whether voluntary participation in a proctored, proficiency-based, virtual reality robotic suturing curriculum using the da Vinci(®) Skills Simulator™ improves robotic suturing performance. Residents and attending surgeons were randomized to participation or non-participation during a 5 week training curriculum. Robotic suturing skills were evaluated before and after training using an inanimate vaginal cuff model, which participants sutured for 10 min using the da Vinci(®) Surgical System. Performances were videotaped, anonymized, and subsequently graded independently by three robotic surgeons. 27 participants were randomized. 23 of the 27 completed both the pre- and post-test, 13 in the training group and 10 in the control group. Mean training time in the intervention group was 238 ± 136 min (SD) over the 5 weeks. The primary outcome (improvement in GOALS+ score) and the secondary outcomes (improvement in GEARS, total knots, satisfactory knots, and the virtual reality suture sponge 1 task) were significantly greater in the training group than the control group in unadjusted analysis. After adjusting for lower baseline scores in the training group, improvement in the suture sponge 1 task remained significantly greater in the training group and a trend was demonstrated to greater improvement in the training group for the GOALS+ score, GEARS score, total knots, and satisfactory knots. PMID:26531197

  19. Surface segregation of fluorinated moieties on random copolymer films controlled by random-coil conformation of polymer chains in solution.

    PubMed

    Xue, Dongwu; Wang, Xinping; Ni, Huagang; Zhang, Wei; Xue, Gi

    2009-02-17

    The relationship between solution properties, film-forming methods, and the solid surface structures of random copolymers composed of butyl methacrylate and dodecafluorheptyl methylacrylate (DFHMA) was investigated by contact angle measurements, X-ray photoelectron spectroscopy, sum frequency generation vibrational spectroscopy, and surface tension measurements. The results, based on thermodynamic considerations, demonstrated that the random copolymer chain conformation at the solution/air interface greatly affected the surface structure of the resulting film, thereby determining the surface segregation of fluorinated moieties on films obtained by various film-forming techniques. When the fluorinated monomer content of the copolymer solution was low, entropic forces dominated the interfacial structure, with the perfluoroalkyl groups unable to migrate to the solution/air interface and thus becoming buried in a random-coil chain conformation. When employing this copolymer solution for film preparation by spin-coating, the copolymer chains in solution were likely extended due to centrifugal forces, thereby weakening the entropy effect of the polymer chains. Consequently, this resulted in the segregation of the fluorinated moieties on the film surface. For the films prepared by casting, the perfluoroalkyl groups were, similar to those in solution, incapable of segregating at the film surface and were thus buried in the random-coil chains. When the copolymers contained a high content of DFHMA, the migration of perfluoroalkyl groups at the solution/air interface was controlled by enthalpic forces, and the perfluoroalkyl groups segregated at the surface of the film regardless of the film-forming technique. The aim of the present work was to obtain an enhanced understanding of the formation mechanism of the chemical structure on the surface of the polymer film, while demonstrating that film-forming methods may be used in practice to promote the segregation of fluorinated

  20. Factors Influencing Hand Washing Behaviour in Primary Schools: Process Evaluation within a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Chittleborough, Catherine R.; Nicholson, Alexandra L.; Basker, Elaine; Bell, Sarah; Campbell, Rona

    2012-01-01

    This article explores factors that may influence hand washing behaviour among pupils and staff in primary schools. A qualitative process evaluation within a cluster randomized controlled trial included pupil focus groups (n = 16, aged 6-11 years), semi-structured interviews (n = 16 teachers) and observations of hand washing facilities (n = 57).…

  1. Lower extremity power training in elderly subjects with moderate mobility limitations: A randomized controlled trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Fifty-seven community-dwelling older adults were randomized to either high-velocity high-power training (POW), slow-velocity progressive resistance training (STR) or a control group of lower extremity stretching (CON). Training was performed three times per week for 12 weeks and subjects completed t...

  2. Randomized Controlled Trial of Video Self-Modeling Following Speech Restructuring Treatment for Stuttering

    ERIC Educational Resources Information Center

    Cream, Angela; O'Brian, Sue; Jones, Mark; Block, Susan; Harrison, Elisabeth; Lincoln, Michelle; Hewat, Sally; Packman, Ann; Menzies, Ross; Onslow, Mark

    2010-01-01

    Purpose: In this study, the authors investigated the efficacy of video self-modeling (VSM) following speech restructuring treatment to improve the maintenance of treatment effects. Method: The design was an open-plan, parallel-group, randomized controlled trial. Participants were 89 adults and adolescents who undertook intensive speech…

  3. Cycling Versus Continuous Mode In Neuromodulator Programming: A Crossover, Randomized, Controlled Trial.

    PubMed

    Beer, Gwendolyn M; Gurule, Margaret M; Komesu, Yuko M; Qualls, Clifford R; Rogers, Rebecca G

    2016-01-01

    This is a randomized, controlled, blind, crossover trial comparing cycling versus continuous programming of a sacral neuromodulator in women diagnosed with overactive bladder (OAB). At 6 months, treatment order significantly affected Overactive Bladder Questionnaire - Short Form (OABq-SF) symptom scores. The cycling followed by continuous stimulation group had superior OABq-SF scores (p > 0.02). PMID:27501593

  4. Randomized Controlled Non-Inferiority Trial of a Telehealth Treatment for Chronic Stuttering: The Camperdown Program

    ERIC Educational Resources Information Center

    Carey, Brenda; O'Brian, Sue; Onslow, Mark; Block, Susan; Jones, Mark; Packman, Ann

    2010-01-01

    Background: Although there are treatments that can alleviate stuttering in adults for clinically significant periods, in Australia there are barriers to the accessibility and availability of best-practice treatment. Aims: This parallel group, non-inferiority randomized controlled trial with multiple blinded outcome assessments investigated whether…

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

    ERIC Educational Resources Information Center

    Leung, Cynthia; Tsang, Sandra; Heung, Kitty

    2015-01-01

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

  6. Randomized Controlled Caregiver Mediated Joint Engagement Intervention for Toddlers with Autism

    ERIC Educational Resources Information Center

    Kasari, Connie; Gulsrud, Amanda C.; Wong, Connie; Kwon, Susan; Locke, Jill

    2010-01-01

    This study aimed to determine if a joint attention intervention would result in greater joint engagement between caregivers and toddlers with autism. The intervention consisted of 24 caregiver-mediated sessions with follow-up 1 year later. Compared to caregivers and toddlers randomized to the waitlist control group the immediate treatment (IT)…

  7. Installing the Communities that Care Prevention System: Implementation Progress and Fidelity in a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Quinby, Rose K.; Hanson, Koren; Brooke-Weiss, Blair; Arthur, Michael W.; Hawkins, J. David; Fagan, Abigail A.

    2008-01-01

    This article describes the degree to which high fidelity implementation of the Communities That Care (CTC) prevention operating system was reached during the first 18 months of intervention in 12 communities in the Community Youth Development Study, a 5-year group randomized controlled trial designed to test the efficacy of the CTC system. CTC…

  8. Ice Hockey Players Using a Weighted Implement when Training on the Ice: A Randomized Control Trial

    ERIC Educational Resources Information Center

    Stark, Timothy W.; Tvoric, Bojan; Walker, Bruce; Noonan, Dom; Sibla, Janeene

    2009-01-01

    The purpose of this study was to investigate the potential for improving hockey players' performance using a weighted implement on the ice. Forty-eight players were tested using a grip strength dynamometer. They also were assessed on their abilities to stick-handle. The participants were randomly placed into a control or research group. The…

  9. Fluoxetine, Smoking, and History of Major Depression: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Spring, Bonnie; Doran, Neal; Pagoto, Sherry; McChargue, Dennis; Cook, Jessica Werth; Bailey, Katherine; Crayton, John; Hedeker, Donald

    2007-01-01

    The study was a randomized placebo-controlled trial testing whether fluoxetine selectively enhances cessation for smokers with a history of depression. Euthymic smokers with (H+, n = 109) or without (H-, n = 138) a history of major depression received 60 mg fluoxetine or placebo plus group behavioral quit-smoking treatment for 12 weeks. Fluoxetine…

  10. Pelvic Static Magnetic Stimulation to Control Urinary Incontinence in Older Women: A Randomized Controlled Trial

    PubMed Central

    Wallis, Marianne C.; Davies, Elizabeth A.; Thalib, Lukman; Griffiths, Susan

    2012-01-01

    Objectives To determine the efficacy of non-invasive static magnetic stimulation (SMS) of the pelvic floor compared to placebo in the treatment of women aged 60 years and over with urinary incontinence for 6 months or more. Subjects and Methods A single-blinded randomized, placebo-controlled, parallel-group trial. Subjects were excluded if they had an implanted electronic device, had experienced a symptomatic urinary tract infection, or had commenced pharmacotherapy for the same in the previous 4 weeks, or if they were booked for pelvic floor or gynecological surgery within the next 3 months. Once written consent was obtained, subjects were randomly assigned to the active SMS group (n=50) or the placebo group (n=51). Treatment was an undergarment incorporating 15 static magnets of 800–1200 Gauss anterior, posterior, and inferior to the pelvis for at least 12 hours a day for 3 months. Placebo was the same protocol with inert metal disks replacing the magnets. Primary outcome measure was cessation of incontinence as measured by a 24-hour pad test. Secondary outcomes were frequency and severity of symptoms as measured by the Bristol Female Lower Urinary Tract Symptoms questionnaire (BFLUTS-SF), the Incontinence Severity Index, a Bothersomeness Visual Analog scale, and a 24-hour bladder diary. Data were collected at baseline and 12 weeks later. Results There were no statistically significant differences between groups in any of the outcome measures from baseline to 12 weeks. Initial evidence of subjective improvement in the treatment group compared to the placebo group was not sustained with sensitivity analysis. Conclusion This study found no evidence that static magnets cure or decrease the symptoms of urinary incontinence. Additional work into the basic physics of the product and garment design is recommended prior to further clinical trials research. PMID:21817123

  11. Community based intervention to optimize osteoporosis management: randomized controlled trial

    PubMed Central

    2010-01-01

    Background Osteoporosis-related fractures are a significant public health concern. Interventions that increase detection and treatment of osteoporosis are underutilized. This pragmatic randomised study was done to evaluate the impact of a multifaceted community-based care program aimed at optimizing evidence-based management in patients at risk for osteoporosis and fractures. Methods This was a 12-month randomized trial performed in Ontario, Canada. Eligible patients were community-dwelling, aged ≥55 years, and identified to be at risk for osteoporosis-related fractures. Two hundred and one patients were allocated to the intervention group or to usual care. Components of the intervention were directed towards primary care physicians and patients and included facilitated bone mineral density testing, patient education and patient-specific recommendations for osteoporosis treatment. The primary outcome was the implementation of appropriate osteoporosis management. Results 101 patients were allocated to intervention and 100 to control. Mean age of participants was 71.9 ± 7.2 years and 94% were women. Pharmacological treatment (alendronate, risedronate, or raloxifene) for osteoporosis was increased by 29% compared to usual care (56% [29/52] vs. 27% [16/60]; relative risk [RR] 2.09, 95% confidence interval [CI] 1.29 to 3.40). More individuals in the intervention group were taking calcium (54% [54/101] vs. 20% [20/100]; RR 2.67, 95% CI 1.74 to 4.12) and vitamin D (33% [33/101] vs. 20% [20/100]; RR 1.63, 95% CI 1.01 to 2.65). Conclusions A multi-faceted community-based intervention improved management of osteoporosis in high risk patients compared with usual care. Trial Registration This trial has been registered with clinicaltrials.gov (ID: NCT00465387) PMID:20799973

  12. In School Settings, Are All RCTs (Randomized Control Trials) Exploratory?

    ERIC Educational Resources Information Center

    Newman, Denis; Jaciw, Andrew P.

    2012-01-01

    The motivation for this paper is the authors' recent work on several randomized control trials in which they found the primary result, which averaged across subgroups or sites, to be moderated by demographic or site characteristics. They are led to examine a distinction that the Institute of Education Sciences (IES) makes between "confirmatory"…

  13. A Randomized Controlled Trial of Two Online Mathematics Curricula

    ERIC Educational Resources Information Center

    Wang, Haiwen; Woodworth, Katrina

    2011-01-01

    This study applies a randomized controlled trial to examine the effects of supplemental instruction using two online mathematics curricula--DreamBox and Reasoning Mind. It is an independent evaluation intended to generate unbiased results that will help inform the ongoing development of a charter school network's hybrid instructional model, which…

  14. Improving Balance in Subacute Stroke Patients: A Randomized Controlled Study

    ERIC Educational Resources Information Center

    Goljar, Nika; Burger, Helena; Rudolf, Marko; Stanonik, Irena

    2010-01-01

    The aim of the study was to compare the efficacy of balance training in a balance trainer, a newly developed mechanical device for training balance, with conventional balance training in subacute stroke patients. This was a randomized controlled study. Fifty participants met the inclusion criteria and 39 finished the study. The participants were…

  15. A double-blind randomized control trial of diazepam

    PubMed Central

    1983-01-01

    A double-blind randomized controlled trial of diazepam against placebo in the management of minor conditions seen in general practice demonstrated that administration of either diazepam or placebo was associated with a substantial reduction in symptomatology three weeks later. There was no demonstrable difference between diazepam and placebo. PMID:6358487

  16. Using Randomized Controlled Trials to Evaluate Interventions for Releasing Prisoners

    ERIC Educational Resources Information Center

    Pettus-Davis, Carrie; Howard, Matthew Owen; Dunnigan, Allison; Scheyett, Anna M.; Roberts-Lewis, Amelia

    2016-01-01

    Randomized controlled trials (RCTs) are rarely used to evaluate social and behavioral interventions designed for releasing prisoners. Objective: We use a pilot RCT of a social support intervention (Support Matters) as a case example to discuss obstacles and strategies for conducting RCT intervention evaluations that span prison and community…

  17. A Systematic Review of Randomized Controlled Studies of Art Therapy

    ERIC Educational Resources Information Center

    Maujean, Annick; Pepping, Christopher A.; Kendall, Elizabeth

    2014-01-01

    This review article examines current knowledge about the efficacy of art therapy based on the findings of 8 randomized controlled trials (RCTs) conducted with adult populations from 2008-2013 that met a high standard of rigor. Of these studies, all but one reported beneficial effects of art therapy. Review findings suggest that art therapy may…

  18. Teacher Awareness Program on Child Abuse: A Randomized Controlled Trial.

    ERIC Educational Resources Information Center

    McGrath, Patrick; And Others

    1987-01-01

    Because teachers lack knowledge of the law, of school board policies, and of issues regarding child abuse and neglect, a professional development workshop was developed and presented to all teachers in the Ottawa Public Schools. Evaluation by a randomized controlled trial showed the workshop effective in increasing and maintaining knowledge.…

  19. Modifying Media Content for Preschool Children: A Randomized Controlled Trial

    PubMed Central

    Garrison, Michelle M.; Herrenkohl, Todd; Haggerty, Kevin; Rivara, Frederick P.; Zhou, Chuan; Liekweg, Kimberly

    2013-01-01

    BACKGROUND: Although previous studies have revealed that preschool-aged children imitate both aggression and prosocial behaviors on screen, there have been few population-based studies designed to reduce aggression in preschool-aged children by modifying what they watch. METHODS: We devised a media diet intervention wherein parents were assisted in substituting high quality prosocial and educational programming for aggression-laden programming without trying to reduce total screen time. We conducted a randomized controlled trial of 565 parents of preschool-aged children ages 3 to 5 years recruited from community pediatric practices. Outcomes were derived from the Social Competence and Behavior Evaluation at 6 and 12 months. RESULTS: At 6 months, the overall mean Social Competence and Behavior Evaluation score was 2.11 points better (95% confidence interval [CI]: 0.78–3.44) in the intervention group as compared with the controls, and similar effects were observed for the externalizing subscale (0.68 [95% CI: 0.06–1.30]) and the social competence subscale (1.04 [95% CI: 0.34–1.74]). The effect for the internalizing subscale was in a positive direction but was not statistically significant (0.42 [95% CI: −0.14 to 0.99]). Although the effect sizes did not noticeably decay at 12 months, the effect on the externalizing subscale was no longer statistically significant (P = .05). In a stratified analysis of the effect on the overall scores, low-income boys appeared to derive the greatest benefit (6.48 [95% CI: 1.60–11.37]). CONCLUSIONS: An intervention to reduce exposure to screen violence and increase exposure to prosocial programming can positively impact child behavior. PMID:23420911

  20. Effects of the FITKids Randomized Controlled Trial on Executive Control and Brain Function

    PubMed Central

    Pontifex, Matthew B.; Castelli, Darla M.; Khan, Naiman A.; Raine, Lauren B.; Scudder, Mark R.; Drollette, Eric S.; Moore, Robert D.; Wu, Chien-Ting; Kamijo, Keita

    2014-01-01

    OBJECTIVE: To assess the effect of a physical activity (PA) intervention on brain and behavioral indices of executive control in preadolescent children. METHODS: Two hundred twenty-one children (7–9 years) were randomly assigned to a 9-month afterschool PA program or a wait-list control. In addition to changes in fitness (maximal oxygen consumption), electrical activity in the brain (P3-ERP) and behavioral measures (accuracy, reaction time) of executive control were collected by using tasks that modulated attentional inhibition and cognitive flexibility. RESULTS: Fitness improved more among intervention participants from pretest to posttest compared with the wait-list control (1.3 mL/kg per minute, 95% confidence interval [CI]: 0.3 to 2.4; d = 0.34 for group difference in pre-to-post change score). Intervention participants exhibited greater improvements from pretest to posttest in inhibition (3.2%, 95% CI: 0.0 to 6.5; d = 0.27) and cognitive flexibility (4.8%, 95% CI: 1.1 to 8.4; d = 0.35 for group difference in pre-to-post change score) compared with control. Only the intervention group increased attentional resources from pretest to posttest during tasks requiring increased inhibition (1.4 µV, 95% CI: 0.3 to 2.6; d = 0.34) and cognitive flexibility (1.5 µV, 95% CI: 0.6 to 2.5; d = 0.43). Finally, improvements in brain function on the inhibition task (r = 0.22) and performance on the flexibility task correlated with intervention attendance (r = 0.24). CONCLUSIONS: The intervention enhanced cognitive performance and brain function during tasks requiring greater executive control. These findings demonstrate a causal effect of a PA program on executive control, and provide support for PA for improving childhood cognition and brain health. PMID:25266425

  1. Treatment of chronic idiopathic urticaria with levamisole: a multicentre, randomized, double-blind, controlled trial.

    PubMed

    Zhang, H; Shan, C; Hua, Z; Zhao, P; Zhang, H

    2009-01-01

    The objective of this study was to evaluate the efficacy of treating chronic idiopathic urticaria (CIU) with levamisole in combination with levocetirizine. This was a multicentre, randomized, double-blind, controlled trial that included 132 patients with active CIU who were treated for 6 weeks with either levocetirizine alone (control group; n = 65) or levamisole plus levocetirizine (treatment group; n = 67). Response to therapy was evaluated by measuring the efficacy rate. After 2 weeks of treatment, there was no significant difference in the efficacy rate between the treatment and control groups (54.84% and 42.37%, respectively). After 6 weeks of treatment, a statistically significant difference in the efficacy rate was observed between the groups (76.27% and 54.39% for the treatment and control groups, respectively). This study demonstrated that a combination of levamisole plus levocetirizine is more effective than levocetirizine alone and potentially provides a new, promising approach to the treatment of CIU. PMID:19761700

  2. Mindfulness-based therapy in adults with an autism spectrum disorder: a randomized controlled trial.

    PubMed

    Spek, Annelies A; van Ham, Nadia C; Nyklíček, Ivan

    2013-01-01

    Research shows that depression and anxiety disorders are the most common psychiatric concern in autism spectrum disorders (ASD). Mindfulness-based therapy (MBT) has been found effective in reducing anxiety and depression symptoms, however research in autism is limited. Therefore, we examined the effects of a modified MBT protocol (MBT-AS) in high-functioning adults with ASD. 42 participants were randomized into a 9-week MBT-AS training or a wait-list control group. Results showed a significant reduction in depression, anxiety and rumination in the intervention group, as opposed to the control group. Furthermore, positive affect increased in the intervention group, but not in the control group. Concluding, the present study is the first controlled trial to demonstrate that adults with ASD can benefit from MBT-AS. PMID:22964266

  3. RANDOMIZED CONTROLLED CLINICAL TRIALS IN ORTHOPEDICS: DIFFICULTIES AND LIMITATIONS

    PubMed Central

    Malavolta, Eduardo Angeli; Demange, Marco Kawamura; Gobbi, Riccardo Gomes; Imamura, Marta; Fregni, Felipe

    2015-01-01

    Randomized controlled clinical trials (RCTs) are considered to be the gold standard for evidence-based medicine nowadays, and are important for directing medical practice through consistent scientific observations. Steps such as patient selection, randomization and blinding are fundamental for conducting a RCT, but some additional difficulties are presented in trials that involve surgical procedures, as is common in orthopedics. The aim of this article was to highlight and discuss some difficulties and possible limitations on RCTs within the field of surgery. PMID:27027037

  4. A Chinese Mind-Body Exercise Improves Self-Control of Children with Autism: A Randomized Controlled Trial

    PubMed Central

    Chan, Agnes S.; Sze, Sophia L.; Siu, Nicolson Y.; Lau, Eliza M.; Cheung, Mei-chun

    2013-01-01

    Self-control problems commonly manifest as temper outbursts and repetitive/rigid/impulsive behaviors, in children with autism spectrum disorders (ASD), which often contributes to learning difficulties and caregiver burden. The present study aims to compare the effect of a traditional Chinese Chan-based mind-body exercise, Nei Yang Gong, with that of the conventional Progressive Muscle Relaxation (PMR) technique in enhancing the self-control of children with ASD. Forty-six age- and IQ-matched ASD children were randomly assigned to receive group training in Nei Yang Gong (experimental group) or PMR (control group) twice per week for four weeks. The participants’ self-control was measured by three neuropsychological tests and parental rating on standardized questionnaires, and the underlying neural mechanism was assessed by the participants’ brain EEG activity during an inhibitory-control task before and after intervention. The results show that the experimental group demonstrated significantly greater improvement in self-control than the control group, which concurs with the parental reports of reduced autistic symptoms and increased control of temper and behaviors. In addition, the experimental group showed enhanced EEG activity in the anterior cingulate cortex, a region that mediates self-control, whereas the PMR group did not. The present findings support the potential application of Chinese Chan-based mind-body exercises as a form of neuropsychological rehabilitation for patients with self-control problems. Chinese Clinical Trial Registry; Registration No.: ChiCTR-TRC-12002561; URL: www.chictr.org. PMID:23874533

  5. The quality of randomized controlled trials in major anesthesiology journals.

    PubMed

    Greenfield, Mary Lou V H; Rosenberg, Andrew L; O'Reilly, Michael; Shanks, Amy M; Sliwinski, Michelle J; Nauss, Michael D

    2005-06-01

    Increased attention has been directed at the quality of randomized controlled trials (RCTs) and how they are being reported. We examined leading anesthesiology journals to identify if there were specific areas for improvement in the design and analysis of published clinical studies. All RCTs that appeared between January 2000 and December 2000 in leading anesthesiology journals (Anesthesiology,Anesthesia & Analgesia,Anaesthesia, and Canadian Journal of Anaesthesia) were retrieved by a MEDLINE search. We used a previously validated assessment tool, including 14 items associated with study quality, to determine a quality score for each article. The overall mean weighted quality score was 44% +/- 16%. Overall average scores were relatively high for appropriate controls (77% +/- 7%) and discussions of side effects (67% +/- 6%). Scores were very low for randomization blinding (5% +/- 2%), blinding observers to results (1% +/- 1%), and post-beta estimates (16% +/- 13%). Important pretreatment clinical predictors were absent in 32% of all studies. Significant improvement in the reporting and conduct of RCTs is required and should focus on randomization methodology, the blinding of investigators, and sample size estimates. Repeat assessments of the literature may improve the adoption of guidelines for the improvement of the quality of randomized controlled trials. PMID:15920210

  6. [Caries prevention strategies for 6-year-olds. A randomized controlled study].

    PubMed

    Vermaire, J H; van Loveren, C

    2015-04-01

    A randomized controlled study of caries prevention strategies was conducted on patients with a mixed socioeconomic status in a large general dental practice in the Netherlands. A group of children following a non-operative caries treatment programme (NOCTP) was compared to a control group and a group that also received 2 topical fluoride applications (IPFA) as a supplement to the control programme (receiving a dental check-up twice a year with topical fluoride applications and routinely sealing of the first permanent molars). A total of 230 6-year-old children were randomly assigned to one of these groups. After 3 years, 179 children were studied again (54 NOCTP, 62 IPFA and 63 controls). Caries-increment was lowest in the NOCTP group (0.15 DMFS). In the IPFA group and the control group DMFS-increments were 0.34 and 0.47 respectively. Although the results of this study are very promising, a follow-up study on a larger scale is required to make clear whether the application of NOCTP is more effective than standard prevention in general practice. PMID:26210120

  7. Effects of Resistance Exercise Applied Early After Coronary Artery Bypass Grafting: a Randomized Controlled Trial

    PubMed Central

    Ximenes, Nayana Nazaré Pessoa Sousa; Borges, Daniel Lago; Lima, Reijane Oliveira; Silva, Mayara Gabrielle Barbosa e; da Silva, Luan Nascimento; Costa, Marina de Albuquerque Gonçalves; Baldez, Thiago Eduardo Pereira; Nina, Vinícius José da Silva

    2015-01-01

    OBJECTIVE To evaluate the effects of resistance exercise applied early after coronary artery bypass grafting. METHODS It is a randomized controlled trial with 34 patients undergoing coronary artery bypass grafting between August 2013 and May 2014. Patients were randomized into two groups by simple draw: a control group (n=17), who received conventional physical therapy and an intervention group (n=17), who received, additionally, resistance exercise. Pulmonary function and functional capacity were evaluated in preoperative period and hospital discharge by spirometry and the six-minute walk test. For statistical analysis, we used the following tests: Shapiro-Wilk, Mann-Whitney, Student's t and Fisher's exact. Variables with P<0.05 were considered significant. RESULTS Groups were homogeneous in terms of demographic, clinical and surgical variables. Resistance exercise exerted no effect on pulmonary function of intervention group compared to control group. However, intervention group maintained functional capacity at hospital discharge measured by percentage of predict distance in 6MWT (54.122.7% vs. 52.515.5%, P=0.42), while control group had a significant decrease (59.211.1% vs. 50.69.9%, P<0.016). CONCLUSION Our results indicate that resistance exercise, applied early, may promote maintenance of functional capacity on coronary artery bypass grafting patients, having no impact on pulmonary function when compared to conventional physical therapy. PMID:26934401

  8. Effect of visual biofeedback to acquire supraglottic swallow in healthy individuals: a randomized-controlled trial.

    PubMed

    Imada, Miho; Kagaya, Hitoshi; Ishiguro, Yuriko; Kato, Miho; Inamoto, Yoko; Tanaka, Takashi; Shibata, Seiko; Saitoh, Eiichi

    2016-06-01

    The aim of this study is to evaluate the effect of visual biofeedback therapy in acquiring supraglottic swallow (SGS) in a randomized-controlled trial with healthy individuals. Eighteen individuals (mean age, 26 years) who could not close or keep closed the vocal folds before and during the swallow in SGS were allocated randomly to either a visual biofeedback group (eight individuals) or a nonbiofeedback group (10 individuals). A videoendoscope was inserted intranasally and an SGS exercise, using 4 ml of green-colored water, was performed 30 times per day up to 5 days. When the participant failed to perform SGS, the result was provided only to the participants in the visual biofeedback group. The median length of time until acquiring SGS was 1.5 days in the visual biofeedback group and 3.5 days in the nonbiofeedback group (P=0.040). We concluded that visual biofeedback effectively enabled participants to acquire SGS earlier. PMID:26795716

  9. Randomized controlled trials in diving and hyperbaric medicine.

    PubMed

    Bennett, Michael H

    2013-01-01

    Randomized controlled trials (RCTs) are widely accepted as the most appropriate methodology available for the investigation of health interventions. This is because of the low potential for systematic bias and the ability to assume causality. Well-designed RCTs, often modified by the addition of blinding participants to the treatment allocated, greatly assist physicians and funding agencies in deciding on the most effective and cost-efficient methods available to prevent and treat ill health. One of the problems for hyperbaric physicians is the widely scattered nature of the evidence, making retrieval and appraisal problematic. This review assembles the randomized evidence in order to assist practitioners, discusses the nature of randomized trials and explores approaches to designing and performing powerful and convincing trials in this area. It is extracted from the UHMS Report Hyperbaric Oxygen Therapy Indications. PMID:24224286

  10. Massage Therapy and Labor Outcomes: a Randomized Controlled Trial

    PubMed Central

    Janssen, Patricia; Shroff, Farah; Jaspar, Paula

    2012-01-01

    Introduction Massage is a time-honored method by which women have received comfort throughout the millennia, yet it has not been rigorously evaluated in the modern day delivery suite. No study to date that we are aware of has evaluated the effect of massage therapy by a regulated massage therapist on labor pain. The purpose of this study was to evaluate the effectiveness of massage therapy provided by registered massage therapists in managing pain among women in active labor. Methods BC Women’s Hospital, Vancouver, BC. Research Design: a randomized controlled trial. Participants: 77 healthy nulliparous women presenting in spontaneous labor. Intervention: Swedish massage administered for up to five hours by a registered massage therapist during labor vs. standard care. Main outcome measures include: cervical dilation at the time of administration of epidural, compared using estimated marginal means in an analysis of covariance. We also compared perception of pain at three time periods during labor according to cervical dilation at 3–4 cm, 5–7 cm, and 8–10 cm using the McGill Present Pain Intensity Scale. Results The mean cervical dilation at the time of epidural insertion after adjustment for station of the presenting part, cervical dilation, and status of membranes on admission to hospital was 5.9 cm (95% CI 5.2–6.7) compared to 4.9 in the control group (95% CI 4.2–5.8). Scores on the McGill Pain Scale were consistently lower in the massage therapy group (13.3 vs. 16.9 at 3–4 cm, 13.3 vs. 15.8 at 5–6 cm, and 19.4 vs. 28.3 at 7–8 cm), although these differences were not statistically significant. Conclusions Our findings from this pilot study suggest that massage therapy by a registered massage therapist has the potential to be an effective means of pain management that may be associated with delayed use of epidural analgesia. It may therefore have the potential to reduce exposure to epidural analgesia during labor and decrease rates of associated

  11. Cognitive-Behavioral Treatment for Panic Disorder with Agoraphobia: A Randomized, Controlled Trial and Cost-Effectiveness Analysis

    ERIC Educational Resources Information Center

    Roberge, Pasquale; Marchand, Andre; Reinharz, Daniel; Savard, Pierre

    2008-01-01

    A randomized, controlled trial was conducted to examine the cost-effectiveness of cognitive-behavioral treatment (CBT) for panic disorder with agoraphobia. A total of 100 participants were randomly assigned to standard (n = 33), group (n = 35), and brief (n = 32) treatment conditions. Results show significant clinical and statistical improvement…

  12. Reinforcement Behavior Therapy by Kindergarten Teachers on Preschool Children’s Aggression: A Randomized Controlled Trial

    PubMed Central

    Yektatalab, Shahrzad; Alipour, Abdolrasool; Edraki, Mitra; Tavakoli, Pouran

    2016-01-01

    Background: Aggression is a kind of behavior that causes damage or harm to others. The prevalence of aggression is 8–20% in 3–6 years old children. The present study aimed to assess the effect of training kindergarten teachers regarding reinforcement behavior therapy on preschoolers’ aggression. Methods: In this cluster randomized control trial, 14 out of 35 kindergarten and preschool centers of Mohr city, Iran, were chosen using random cluster sampling and then randomly assigned to an intervention and a control group. All 370 kindergarten and preschool children in 14 kindergarten were assessed by preschoolers’ aggression questionnaire and 60 children who obtained a minimum aggression score of 117.48 for girls and 125.77 for boys were randomly selected. The teachers in the intervention group participated in 4 educational sessions on behavior therapy and then practiced this technique under the supervision of the researcher for two months. Preschoolers’ aggression questionnaire was computed in both intervention and control groups before and after a two-month period. Results: The results demonstrated a significant statistical difference in the total aggression score (P=0.01), verbal (P=0.02) and physical (P=0.01) aggression subscales scores in the intervention group in comparison to the control group after the intervention. But the scores of relational aggression (P=0.09) and impulsive anger (P=0.08) subscales were not statistically different in the intervention group compared to the controls. Conclusion: This study highlighted the importance of teaching reinforcement behavior therapy by kindergarten teachers in decreasing verbal and physical aggression in preschoolers. Trial Registration Number: IRCT2014042617436N1 PMID:26793733

  13. Psychosocial and Cardiac Outcomes of Yoga for ICD Patients: A Randomized Clinical Control Trial

    PubMed Central

    Toise, Stefanie C.F.; Sears, Samuel F.; Schoenfeld, Mark H.; Blitzer, Mark L.; Marieb, Mark A.; Drury, John H.; Slade, Martin D.; Donohue, Thomas J.

    2013-01-01

    Background Because as many as 46% of implantable cardioverter defibrillator (ICD) patients experience clinical symptoms of shock anxiety, this randomized controlled study evaluated the efficacy of adapted yoga (vs. usual care) in reducing clinical psychosocial risks shown to impact morbidity and mortality in ICD recipients. Methods Forty-six participants were randomized to a control group or an 8-week adapted yoga group that followed a standardized protocol with weekly classes and home practice. Medical and psychosocial data were collected at baseline and follow-up, then compared and analyzed. Results Total shock anxiety decreased for the yoga group and increased for the control group, t(4.43, 36), p < 0.0001, with significant differences between these changes. Similarly, consequential anxiety decreased for the yoga group but increased for the control group t(2.86,36) p = 0.007. Compared to the control, the yoga group had greater overall self-compassion, t(–2.84,37), p = 0.007, and greater mindfulness, t(–2.10,37) p = 0.04, at the end of the study. Exploratory analyses utilizing a linear model (R2 = .98) ofobserved device-treated ventricular (DTV) events revealed that the expected number of DTV events in the yoga group was significantly lower than in the control group (p<.0001). Compared to the control, the yoga group had a 32% lower risk of experiencing device-related firings at end of follow-up. Conclusions Our study demonstrated psychosocial benefits from a program of adapted yoga (vs. usual care) for ICD recipients. This data supports continued research to better understand the role of complementary medicine to address ICD-specific stress in cardiac outcomes. PMID:23981048

  14. Perceptions of Massage Therapists Participating in a Randomized Controlled Trial

    PubMed Central

    Perlman, Adam; Dreusicke, Mark; Keever, Teresa; Ali, Ather

    2015-01-01

    Background Clinical practice and randomized trials often have disparate aims, despite involving similar interventions. Attitudes and expectancies of practitioners influence patient outcomes, and there is growing emphasis on optimizing provider–patient relationships. In this study, we evaluated the experiences of licensed massage therapists involved in a randomized controlled clinical trial using qualitative methodology. Methods Seven massage therapists who were interventionists in a randomized controlled trial participated in structured interviews approximately 30 minutes in length. Interviews focused on their experiences and perceptions regarding aspects of the clinical trial, as well as recommendations for future trials. Transcribed interviews were analyzed for emergent topics and themes using standard qualitative methods. Results Six themes emerged. Therapists discussed 1) promoting the profession of massage therapy through research, 2) mixed views on using standardized protocols, 3) challenges of sham interventions, 4) participant response to the sham intervention, 5) views on scheduling and compensation, and 6) unanticipated benefits of participating in research. Conclusions Therapists largely appreciated the opportunity to promote massage through research. They demonstrated insight and understanding of the rationale for a clinical trial adhering to a standardized protocol. Evaluating the experiences and ideas of complementary and alternative medicine practitioners provides valuable insight that is relevant for the implementation and design of randomized trials. PMID:26388961

  15. Comparison of Ondansetron and Meperidine for Treatment of Postoperative Shivering: A Randomized Controlled Clinical Trial

    PubMed Central

    Mahoori, Alireza; Noroozinia, Heydar; Hasani, Ebrahim; Soltanahmadi, Maryam

    2014-01-01

    Background: The involved neurotransmitter pathways in the postoperative shivering (POS) are poorly understood. Recently, 5-hydroxytryptamine 3 (5-HT3) receptor antagonists have been reported to prevent POS. We investigated the effect of ondansetron, a 5-HT3 antagonist that is used to treat postoperative nausea and vomiting, on shivering. Objectives: This study aimed to compare the efficacy of ondansetron and meperidine in the treatment of shivering after general anesthesia. Patients and Methods: In this double-blinded randomized clinical trial, 83 patients (age range, 18-60 years) who had shivering after general anesthesia were randomly allocated to any of these three groups: Group A, (number = 27) received 4 mg of intravenous ondansetron, Group B, (number = 27) received 8 mg of intravenous ondansetron, and Group C, (number = 29) received 0.4 mg/kg of intravenous meperidine at recovery room. The surface temperatures and the incidence as well as intensity of shivering were recorded. Results: Shivering was controlled in 16 patients (59%) in Group A, 22 (81%) in Group B, and 25 (86%) in Group C (P = 0.01). Within each group, there were no significant differences among the surface temperature in recovery room. Patients in groups A and B had significantly lower incidence of nausea and vomiting than group C (P = 0.01). Conclusions: Ondansetron and meperidine have similar effects on shivering. We concluded that 8 mg of intravenous ondansetron can control shivering and this is the dose of choice, especially in patients with POS with nausea and vomiting. PMID:25389473

  16. Effect of ozonated oil and chlorhexidine gel on plaque induced gingivitis: A randomized control clinical trial

    PubMed Central

    Indurkar, Maya Sanjeev; Verma, Renu

    2016-01-01

    Background: Several chemotherapeutic agents have been developed to prevent gingivitis and its progression into periodontitis. In this present study, the efficacy of ozonated oil and chlorhexidine gel was assessed and compared on plaque induced gingivitis. Aim: To evaluate the effect of ozonated oil on plaque induced gingivitis and to compare its efficacy with chlorhexidine gel. Materials and Methods: A total of 20 subjects, aged from 18 to 65 years, with plaque-induced gingivitis were selected from the outpatient Department of Periodontology, Government Dental College and Hospital, Aurangabad, for this study. They were divided randomly into the test or ozonated oil group (Group I) and the control or chlorhexidine gel group (Group II) with 10 subjects in each group. Subjects were randomly assigned to massage their gingiva thrice a day for 3 weeks with ozonated oil (test), and chlorhexidine gel (control). Plaque index and gingival index scores were recorded for the 20 subjects at baseline and after 3 weeks. Results: Ozonated oil (Group I) and chlorhexidine gel (Group II) groups showed statistically significant differences with respect to plaque index and gingival index, from the baseline to 3 weeks (P < 0.001 in both). But the difference between Group I and Group II, at the end of the study period, was not statistically significant with respect to the plaque index and gingival index. Conclusions: The ozonated oil and chlorhexidine gel, both can be used as an effective agent in maintaining and improving gingival health. PMID:27041835

  17. Effect of pharmacist-led patient education on glycemic control of type 2 diabetics: a randomized controlled trial

    PubMed Central

    Farsaei, Shadi; Sabzghabaee, Ali Mohammad; Zargarzadeh, Amir Hooshang; Amini, Massoud

    2011-01-01

    BACKGROUND: This study was conducted to evaluate the effect of a clinical pharmacist-led patient education program for type 2 diabetic patients at Isfahan Endocrine & Metabolism Research Center (IEMRC) from April 2008 to January 2009. METHODS: In a randomized controlled clinical trial, a total of 172 patients with uncontrolled type 2 diabetes were selected and randomly allocated into control and intervention groups. After taking informed written consent, the intervention group received an educational program about oral anti-hyperglycemic medications, adherence, diabetes dairy log and pill box usage. Patient's glycemic control in the intervention group was followed for three months through either telephone or face to face interviews with the pharmacist. Fasting blood glucose and HbA1c were measured at the start and end of the pharmacistled drug education program for both intervention and control groups. RESULTS: After a three months follow-up, mean fasting blood glucose and HbA1c of the patients in the intervention group decreased significantly compared to control group (p < 0.001). CONCLUSIONS: This study demonstrates an improvement in diabetes management of type 2 diabetics by involving a pharmacist in the multidisciplinary teams in the outpatient clinics. The results suggest the benefits of adding adherence education to the diabetic education programs. PMID:21448382

  18. Considerations for Designing Group Randomized Trials of Professional Development with Teacher Knowledge Outcomes

    ERIC Educational Resources Information Center

    Kelcey, Ben; Phelps, Geoffrey

    2013-01-01

    Despite recent shifts in research emphasizing the value of carefully designed experiments, the number of studies of teacher professional development with rigorous designs has lagged behind its student outcome counterparts. We outline a framework for the design of group randomized trials (GRTs) with teachers' knowledge as the outcome and…

  19. Using Multilevel Mixtures to Evaluate Intervention Effects in Group Randomized Trials

    ERIC Educational Resources Information Center

    Van Horn, M. Lee; Fagan, Abigail A.; Jaki, Thomas; Brown, Eric C.; Hawkins, J. David; Arthur, Michael W.; Abbott, Robert D.; Catalano, Richard F.

    2008-01-01

    There is evidence to suggest that the effects of behavioral interventions may be limited to specific types of individuals, but methods for evaluating such outcomes have not been fully developed. This study proposes the use of finite mixture models to evaluate whether interventions, and, specifically, group randomized trials, impact participants…

  20. Mediation and Spillover Effects in Group-Randomized Trials with Application to the 4Rs Evaluation

    ERIC Educational Resources Information Center

    VanderWeele, Tyler J.; Hong, Guanglei; Jones, Stephanie M.; Brown, Joshua L.

    2011-01-01

    In this paper the authors extend recent work on mediation in a multilevel setting and on causal inference under interference among units to develop a template for the mediation analysis of group randomized educational interventions. The present work will contribute to the literature on interference, in particular on interference in the context of…

  1. Increasing the Degrees of Freedom in Future Group Randomized Trials: The "df*" Method Revisited

    ERIC Educational Resources Information Center

    Murray, David M.; Blitstein, Jonathan L.; Hannan, Peter J.; Shadish, William R.

    2012-01-01

    Background: This article revisits an article published in Evaluation Review in 2005 on sample size estimation and power analysis for group-randomized trials. With help from a careful reader, we learned of an important error in the spreadsheet used to perform the calculations and generate the results presented in that article. As we studied the…

  2. New Empirical Evidence for the Design of Group Randomized Trials in Education

    ERIC Educational Resources Information Center

    Jacob, Robin; Zhu, Pei; Bloom, Howard

    2010-01-01

    This article provides practical guidance for researchers who are designing studies that randomize groups to measure the impacts of educational interventions. The article (a) provides new empirical information about the values of parameters that influence the precision of impact estimates (intraclass correlations and R[superscript 2] values) and…

  3. Impact of pedometer-based walking on menopausal women's sleep quality: a randomized controlled trial.

    PubMed

    Tadayon, M; Abedi, P; Farshadbakht, F

    2016-08-01

    Objective Sleep disturbances are one of the most common psycho-physiological issues among postmenopausal women. This study was designed to evaluate the impact of walking with a pedometer on the sleep quality of postmenopausal Iranian women. Methods This randomized, controlled trial was conducted on 112 women who were randomly assigned to two groups. The women in the intervention group (n = 56) were asked to walk with a pedometer each day for 12 weeks and to increase their walking distance by 500 steps per week. A sociodemographic instrument and the Pittsburgh Sleep Quality Index were used to collect data. Sleep quality was measured at baseline, 4, 8, and 12 weeks after intervention. The control group (n = 56) did not receive any intervention. Results After 12 weeks, subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction improved to a significantly greater extent in the intervention group than in the control group (p < 0.05). The total sleep quality score was significantly higher in the intervention group than in the control group (0.64 vs. 0.98, p = 0.001). Conclusion This study showed that walking with a pedometer is an easy and cost-effective way to improve the quality of sleep among postmenopausal women. Use of this method in public health centers is recommended. PMID:26757356

  4. Supported Employment for the Reintegration of Disability Pensioners with Mental Illnesses: A Randomized Controlled Trial

    PubMed Central

    Viering, Sandra; Jäger, Matthias; Bärtsch, Bettina; Nordt, Carlos; Rössler, Wulf; Warnke, Ingeborg; Kawohl, Wolfram

    2015-01-01

    Work is beneficial for the recovery from mental illness. Although the approach of individual placement and support (IPS) has been shown to be effective in Europe, it has not yet been widely implemented in European health care systems. The aim of this randomized controlled trial was to assess the effectiveness of IPS for disability pensioners with mental illnesses new on disability benefits in Switzerland. In the study at hand, 250 participants were randomly assigned to either the control or the intervention group. The participants in the intervention group received job coaching according to IPS during 2 years. The control group received no structured support. Both groups were interviewed at baseline and followed up every 6 months (baseline, 6, 12, 16, 18, 24 months) for 2 years. Primary outcome was to obtain a job in the competitive employment. IPS was more effective for the reintegration into the competitive employment market for disability pensioners than the control condition. Thirty-two percent of the participants of the intervention group and 12% of the control group obtained new jobs in the competitive employment. IPS is also effective for the reintegration into competitive employment of people with mental illness receiving disability pensions. PMID:26539425

  5. Observer-based controller design for networked control systems with sensor quantisation and random communication delay

    NASA Astrophysics Data System (ADS)

    Liu, Ming; You, Jia

    2012-10-01

    This article addresses the study of observer-based controller design for network-based control systems in the presence of output quantisation and random communication delay simultaneously. In the communication channel, the output measurement are quantised before transmission, and two kinds of network-induced delays are taken into account simultaneously: (i) random delay from sensor to controller and (ii) random delay from controller to actuator. These two types of random delays are modelled as two independent Bernoulli distributed white sequences. The observer-based controller is synthesised to stabilise the networked closed-loop system in the sense of stochastic stability. Sufficient conditions for the existence of the controller are provided by stochastic Lyapunov method. An illustrative numerical example is employed to demonstrate the applicability and flexibility of the proposed design strategy.

  6. A Randomized Controlled Trial of Conbercept Pretreatment before Vitrectomy in Proliferative Diabetic Retinopathy

    PubMed Central

    Yang, Xiaochun; Wang, Ruili; Mei, Yan; Liu, Jun; Zhang, Ting; Zhao, Haiyan

    2016-01-01

    Purpose. To determine the efficacy and safety of preoperative intravitreal conbercept (IVC) injection before vitrectomy for proliferative diabetic retinopathy (PDR). Methods. 107 eyes of 88 patients that underwent pars plana vitrectomy (PPV) for active PDR were enrolled. All patients were assigned randomly to either preoperative IVC group or control group. Follow-up examinations were performed for three months after surgery. The primary bioactivity measures were severity of intraoperative bleeding, incidence of early and late recurrent VH, vitreous clear-up time, and best-corrected visual acuity (BCVA) levels. The secondary safety measures included intraocular pressure, endophthalmitis, rubeosis, tractional retinal detachment, and systemic adverse events. Results. The incidence and severity of intraoperative bleeding were significantly lower in IVC group than in the control group. The average vitreous clear-up time of early recurrent VH was significantly shorter in IVC group compared with that in control group. There was no significant difference in vitreous clear-up time of late recurrent VH between the two groups. Patients that received pretreatment of conbercept had much better BCVA at 3 days, 1 week, and 1 month after surgery than control group. Moreover, both patients with improved BCVA were greater in IVC group than in control group at each follow-up. Conclusions. Conbercept pretreatment could be an effective adjunct to vitrectomy in accelerating postoperative vitreous clear-up and acquiring stable visual acuity restoration for PDR. PMID:27034822

  7. Sleep Promotion Program for Improving Sleep Behaviors in Adolescents: A Randomized Controlled Pilot Study.

    PubMed

    John, Bindu; Bellipady, Sumanth Shetty; Bhat, Shrinivasa Undaru

    2016-01-01

    Aims. The purpose of this pilot trial was to determine the efficacy of sleep promotion program to adapt it for the use of adolescents studying in various schools of Mangalore, India, and evaluate the feasibility issues before conducting a randomized controlled trial in a larger sample of adolescents. Methods. A randomized controlled trial design with stratified random sampling method was used. Fifty-eight adolescents were selected (mean age: 14.02 ± 2.15 years; intervention group, n = 34; control group, n = 24). Self-report questionnaires, including sociodemographic questionnaire with some additional questions on sleep and activities, Sleep Hygiene Index, Pittsburgh Sleep Quality Index, The Cleveland Adolescent Sleepiness Questionnaire, and PedsQL™ Present Functioning Visual Analogue Scale, were used. Results. Insufficient weekday-weekend sleep duration with increasing age of adolescents was observed. The program revealed a significant effect in the experimental group over the control group in overall sleep quality, sleep onset latency, sleep duration, daytime sleepiness, and emotional and overall distress. No significant effect was observed in sleep hygiene and other sleep parameters. All target variables showed significant correlations with each other. Conclusion. The intervention holds a promise for improving the sleep behaviors in healthy adolescents. However, the effect of the sleep promotion program treatment has yet to be proven through a future research. This trial is registered with ISRCTN13083118. PMID:27088040

  8. Sleep Promotion Program for Improving Sleep Behaviors in Adolescents: A Randomized Controlled Pilot Study

    PubMed Central

    John, Bindu; Bellipady, Sumanth Shetty; Bhat, Shrinivasa Undaru

    2016-01-01

    Aims. The purpose of this pilot trial was to determine the efficacy of sleep promotion program to adapt it for the use of adolescents studying in various schools of Mangalore, India, and evaluate the feasibility issues before conducting a randomized controlled trial in a larger sample of adolescents. Methods. A randomized controlled trial design with stratified random sampling method was used. Fifty-eight adolescents were selected (mean age: 14.02 ± 2.15 years; intervention group, n = 34; control group, n = 24). Self-report questionnaires, including sociodemographic questionnaire with some additional questions on sleep and activities, Sleep Hygiene Index, Pittsburgh Sleep Quality Index, The Cleveland Adolescent Sleepiness Questionnaire, and PedsQL™ Present Functioning Visual Analogue Scale, were used. Results. Insufficient weekday-weekend sleep duration with increasing age of adolescents was observed. The program revealed a significant effect in the experimental group over the control group in overall sleep quality, sleep onset latency, sleep duration, daytime sleepiness, and emotional and overall distress. No significant effect was observed in sleep hygiene and other sleep parameters. All target variables showed significant correlations with each other. Conclusion. The intervention holds a promise for improving the sleep behaviors in healthy adolescents. However, the effect of the sleep promotion program treatment has yet to be proven through a future research. This trial is registered with ISRCTN13083118. PMID:27088040

  9. Randomized Controlled Trials of Add-On Antidepressants in Schizophrenia

    PubMed Central

    Joffe, Grigori; Stenberg, Jan-Henry

    2015-01-01

    Background: Despite adequate treatment with antipsychotics, a substantial number of patients with schizophrenia demonstrate only suboptimal clinical outcome. To overcome this challenge, various psychopharmacological combination strategies have been used, including antidepressants added to antipsychotics. Methods: To analyze the efficacy of add-on antidepressants for the treatment of negative, positive, cognitive, depressive, and antipsychotic-induced extrapyramidal symptoms in schizophrenia, published randomized controlled trials assessing the efficacy of adjunctive antidepressants in schizophrenia were reviewed using the following parameters: baseline clinical characteristics and number of patients, their on-going antipsychotic treatment, dosage of the add-on antidepressants, duration of the trial, efficacy measures, and outcomes. Results: There were 36 randomized controlled trials reported in 41 journal publications (n=1582). The antidepressants used were the selective serotonin reuptake inhibitors, duloxetine, imipramine, mianserin, mirtazapine, nefazodone, reboxetin, trazodone, and bupropion. Mirtazapine and mianserin showed somewhat consistent efficacy for negative symptoms and both seemed to enhance neurocognition. Trazodone and nefazodone appeared to improve the antipsychotics-induced extrapyramidal symptoms. Imipramine and duloxetine tended to improve depressive symptoms. No clear evidence supporting selective serotonin reuptake inhibitors’ efficacy on any clinical domain of schizophrenia was found. Add-on antidepressants did not worsen psychosis. Conclusions: Despite a substantial number of randomized controlled trials, the overall efficacy of add-on antidepressants in schizophrenia remains uncertain mainly due to methodological issues. Some differences in efficacy on several schizophrenia domains seem, however, to exist and to vary by the antidepressant subgroups—plausibly due to differences in the mechanisms of action. Antidepressants may not worsen

  10. Teacher awareness program on child abuse: a randomized controlled trial.

    PubMed

    McGrath, P; Cappelli, M; Wiseman, D; Khalil, N; Allan, B

    1987-01-01

    Teachers have a significant role in preventing, detecting and reporting child abuse and neglect. They are hindered in fulfilling this role by a serious lack of knowledge of the law, of school board policies, and of maltreatment. A comprehensive professional development workshop was developed and presented to elementary school teachers. The package was evaluated by means of a randomized controlled trial. The workshop proved to be effective in increasing and maintaining knowledge. PMID:3828866

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

    PubMed

    Howie, Amanda J; Malouff, John M

    2014-01-01

    Problematic anger, which is common, has been associated with a wide range of negative interpersonal and intrapersonal consequences, including violent behaviour, relationship damage, health problems and low self-esteem. This article reports the results of the first randomized controlled trial of brief online cognitive treatment for anger. The sample included 75 adults who were randomly assigned to cognitive treatment or a waiting list control. The analyses with the 59 participants who completed the post-intervention assessment at four weeks after the beginning of the intervention showed that individuals who received the intervention reported significantly lower anger levels than the control group at post-assessment. The treatment group showed a substantial decrease in anger from pre to post. The results suggest that brief online cognitive treatment can be effective for reducing problematic anger in adults. These findings provide an initial support for the development of internet-based cognitive treatment for problematic anger. PMID:25065452

  12. An Eight Month Randomized Controlled Exercise Intervention Alters Resting State Synchrony in Overweight Children

    PubMed Central

    Krafft, Cynthia E.; Pierce, Jordan E.; Schwarz, Nicolette F.; Chi, Lingxi; Weinberger, Abby L.; Schaeffer, David J.; Rodrigue, Amanda L.; Camchong, Jazmin; Allison, Jerry D.; Yanasak, Nathan E.; Liu, Tianming; Davis, Catherine L.; McDowell, Jennifer E.

    2014-01-01

    Children with low aerobic fitness have altered brain function compared to higher-fit children. This study examined the effect of an 8-month exercise intervention on resting state synchrony. Twenty-two sedentary, overweight (body mass index ≥ 85th percentile) children 8–11 years old were randomly assigned to one of two after-school programs: aerobic exercise (n=13) or sedentary attention control (n=9). Before and after the 8-month programs, all subjects participated in resting state functional magnetic resonance imaging scans. Independent components analysis identified several networks, with four chosen for between-group analysis: salience, default mode, cognitive control, and motor networks. The default mode, cognitive control, and motor networks showed more spatial refinement over time in the exercise group compared to controls. The motor network showed increased synchrony in the exercise group with the right medial frontal gyrus compared to controls. Exercise behavior may enhance brain development in children. PMID:24096138

  13. An eight month randomized controlled exercise intervention alters resting state synchrony in overweight children.

    PubMed

    Krafft, C E; Pierce, J E; Schwarz, N F; Chi, L; Weinberger, A L; Schaeffer, D J; Rodrigue, A L; Camchong, J; Allison, J D; Yanasak, N E; Liu, T; Davis, C L; McDowell, J E

    2014-01-01

    Children with low aerobic fitness have altered brain function compared to higher-fit children. This study examined the effect of an 8-month exercise intervention on resting state synchrony. Twenty-two sedentary, overweight (body mass index ≥85th percentile) children 8-11 years old were randomly assigned to one of two after-school programs: aerobic exercise (n=13) or sedentary attention control (n=9). Before and after the 8-month programs, all subjects participated in resting state functional magnetic resonance imaging scans. Independent components analysis identified several networks, with four chosen for between-group analysis: salience, default mode, cognitive control, and motor networks. The default mode, cognitive control, and motor networks showed more spatial refinement over time in the exercise group compared to controls. The motor network showed increased synchrony in the exercise group with the right medial frontal gyrus compared to controls. Exercise behavior may enhance brain development in children. PMID:24096138

  14. Home-based alcohol prevention program for parents and children: A randomized controlled trial.

    PubMed

    Mares, S H W; Lichtwarck-Aschoff, A; Verdurmen, J; Schulten, I; Engels, R C M E

    2016-07-01

    Objective To evaluate the effectiveness of a home-based alcohol prevention program to delay initiation of alcohol use in children. Methods In 2011, a total of 1349 sixth-grade children (M=12.15, SD=0.47) and their mothers who could read and write Dutch were recruited from primary schools in the northern part of the Netherlands. They participated in a cluster randomized controlled trial with two conditions; (1) intervention group (5 modules which families received by mail every 4weeks over 5months), (2) control group (a factsheet information brochure). An independent statistician allocated the schools to the conditions (allocation ratio (1:1)). Participants and data-analyst were blind to randomization. The primary outcome was alcohol initiation. Results Of the participants, 680 were randomized to the intervention and 669 to the control condition. In the intervention condition (N=540) 5.4% of the children drank alcohol compared to 7.1% in the control condition (N=601). The difference was not significant (OR=.99, 95% CI=.96-1.02, p=52). Conclusion The present study showed no effects of 'In control: No alcohol!' on alcohol initiation. A critical evaluation of program design and content, and future studies in different target groups, are suggested. The trial is registered at trialregister.nl, number NTR2474. PMID:27143498

  15. A Randomized Control Trial Comparing the Efficacy of Antiandrogen Monotherapy: Flutamide vs. Bicalutamide.

    PubMed

    Nakai, Yasushi; Tanaka, Nobumichi; Anai, Satoshi; Miyake, Makito; Tatsumi, Yoshihiro; Fujimoto, Kiyohide

    2015-08-01

    The study aims to compare serial changes in prostate-specific antigen (PSA), testosterone, dehydroepiandrosterone (DHEA), and androstenedione in patients treated with either of the antiandrogen agents, bicalutamide or flutamide, using a randomized controlled study. Patients had to meet the following inclusion criteria: (1) presence of histopathologically confirmed prostate cancer, (2) prostate cancer treatment naive, (3) no current treatment with luteinizing hormone-releasing hormone (LH-RH) agonist for sexual interest and physical capacity, (4) clinical stage T1-cT3N0M0, (5) Gleason score ≤ 7, and (6) Cooperative Oncology Group performance status 0-1. Patients were randomly allocated to two groups: flutamide and bicalutamide monotherapy group 1:1. PSA levels were significantly decreased in both groups at 4 weeks. PSA levels were significantly lower in the bicalutamide group compared with the flutamide group at 4 and 8 weeks. Testosterone levels in the bicalutamide group were significantly higher than the baseline levels between 4 and 24 weeks of treatment. Testosterone levels in the flutamide group were significantly increased at 4 and 12 weeks and returned to baseline levels at 16 and 24 weeks. DHEA levels in the bicalutamide group were unchanged from baseline at 4 and 24 weeks. However, DHEA levels in the flutamide group were decreased at 24 weeks. Androstenedione levels increased slightly in both groups, but the increase did not reach statistical significance. PSA, testosterone, and DHEA levels significantly differed between bicalutamide and flutamide monotherapy. PMID:26024831

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

    PubMed

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

    2015-08-01

    Cluster randomized controlled trials (cRCTs; also known as group randomized trials and community-randomized trials) are multilevel experiments in which units that are randomly assigned to experimental conditions are sets of grouped individuals, whereas outcomes are recorded at the individual level. In human cRCTs, clusters that are randomly assigned are typically families, classrooms, schools, worksites, or counties. With growing interest in community-based, public health, and policy interventions to reduce obesity or improve nutrition, the use of cRCTs has increased. Errors in the design, analysis, and interpretation of cRCTs are unfortunately all too common. This situation seems to stem in part from investigator confusion about how the unit of randomization affects causal inferences and the statistical procedures required for the valid estimation and testing of effects. In this article, we provide a brief introduction and overview of the importance of cRCTs and highlight and explain important considerations for the design, analysis, and reporting of cRCTs by using published examples. PMID:26016864

  17. Comparing Mindfulness-Based Group Therapy With Treatment as Usual for Opioid Dependents: A Pilot Randomized Clinical Trial Study Protocol

    PubMed Central

    Imani, Saeed; Atef Vahid, Mohammad Kazem; Gharraee, Banafsheh; Habibi, Mojtaba; Bowen, Sarah; Noroozi, Alireza

    2015-01-01

    Background: In response to high burden of opioid abuse in Iran, Ministry of Health has launched a large-scale opioid maintenance treatment program, delivered through a network of certified drug treatment centers. To promote opioid pharmacotherapies, there is an urgent need to develop and introduce evidence-based psychosocial interventions into the network. Patients and Methods: This is a randomized clinical trial (RCT) to investigate feasibility and effectiveness of adding mindfulness-based group therapy to opioid pharmacotherapies as compared to opioid pharmacotherapies alone. The primary outcomes were treatment retention and percentage of weekly morphine, methamphetamine, and benzodiazepine negative tests. Discussion: This is the first RCT that explores the effectiveness of mindfulness-based relapse prevention group therapy among opioid dependent clients in Iran. The feasibility of group therapy and comparison of outcomes in intervention and control groups should be discussed in the outcome article. PMID:26251659

  18. Back massage intervention for relieving lower back pain in puerperal women: A randomized control trial study.

    PubMed

    Lee, Hsiu-Jung; Ko, Yi-Li

    2015-05-01

    This study evaluates the effectiveness of a back massage (BM) intervention in relieving lower back pain (LBP) in post-partum women.This is a randomized controlled trial study. Sixty normal spontaneous delivery women (response rate: 96.7%), who gave birth at our hospital, participated in this study from February to May of 2012. We randomly assigned 30 women to the experimental group and 30 women to the control group. During the 1 month post-partum period, the women in the experimental group received a BM for 5 consecutive days, whereas the women in the control group received routine care only. The LBP score was assessed according to a pain visual analog scale. After 5 days of intervention, the experimental group (n = 30) experienced significantly less LBP than did the control group (n = 30) (2.97 ± 1.71 vs. 4.43 ± 1.77, t = 3.26, P = 0.002). BM therapy can effectively reduce LBP during the first post-partum month. Additional studies are required to confirm the effects of BM therapy during extended post-partum periods. PMID:26125572

  19. Cardiopulmonary effects of traditional Thai dance on menopausal women: a randomized controlled trial

    PubMed Central

    Janyacharoen, Taweesak; Phusririt, Chonticha; Angkapattamakul, Sariya; Hurst, Cameron P.; Sawanyawisuth, Kittisak

    2015-01-01

    [Purpose] This study evaluated the effects of Thai dance on cardiopulmonary factors in menopausal women. [Subjects] Sixty-six menopausal women aged 40 years or more. [Methods] Subjects were randomly assigned to either the Thai dance or control group. The Thai dance group performed a traditional Thai dancing exercise program for 60 minutes, 3 times per week for 6 weeks. The control group received general health guidance. The 6-minutewalk test, peak expiratory flow, forced vital capacity, forced expiratory volume in one second, maximal voluntary ventilation, and chest expansion were assessed at baseline and at the end of the study. [Results] Sixty-six menopausal women were eligible. At the end of the study, all variables were significantly better in the Thai dance group than the control group. Moreover, all variables improved significantly compared to baseline in the Thai dance group but not in the control group. For example, the mean 6-minutewalk test result in Thai dance group at the end of the study was 285.4 m, which was significantly higher than that at baseline (254.8 m) and the control group at baseline (247.0 m). [Conclusion] A 6-week Thai dance program improves cardiorespiratory endurance in menopausal women. PMID:26357441

  20. Respiratory training as strategy to prevent cognitive decline in aging: a randomized controlled trial

    PubMed Central

    Ferreira, Leandro; Tanaka, Kátia; Santos-Galduróz, Ruth Ferreira; Galduróz, José Carlos Fernandes

    2015-01-01

    Background Inadequate oxygenation may cause lesions and brain atrophy during aging. Studies show a positive association between pulmonary function and the cognitive performance of individuals from middle age on. Objective To investigate the effect of aerobic physical exercises and respiratory training on the blood oxygenation, pulmonary functions, and cognition of the elderly. Design This was a randomized and controlled trial with three parallel groups. A total of 195 community-dwelling elderly were assessed for eligibility; only n=102 were included and allocated into the three groups, but after 6 months, n=68 were analyzed in the final sample. Participants were randomized into a social interaction group (the control group), an aerobic exercise group (the “walking” group), or a respiratory training group (the “breathing” group). The main outcome measures were the Wechsler Adult Intelligence Scale, Wechsler Memory Scale, Wisconsin Card Sorting Test, respiratory muscular strength, cirtometry (thoracic–abdominal circumference); oxygen saturation in arterial blood (SpO2), and hemogram. Results No differences were observed for any of the blood parameters. Aerobic exercise and respiratory training were effective in improving the pulmonary parameters. Better cognitive performance was observed for the breathing group as regards abstraction and mental flexibility. The walking group remained stable in the cognitive performance of most of the tests, except attention. The control group presented worst performance in mental manipulation of information, abstraction, mental flexibility, and attention. Conclusion Our results showed that both the walking and breathing groups presented improvement of pulmonary function. However, only the breathing group showed improved cognitive function (abstraction, mental flexibility). The improvement in cognitive functions cannot be explained by blood parameters, such as SpO2, erythrocytes, hemoglobin, and hematocrit. PMID:25848235

  1. Effect of Vitamin E on Oxaliplatin-induced Peripheral Neuropathy Prevention: A Randomized Controlled Trial

    PubMed Central

    Salehi, Zeinab; Roayaei, Mahnaz

    2015-01-01

    Background: Peripheral neuropathy is one of the most important limitations of oxaliplatin base regimen, which is the standard for the treatment of colorectal cancer. Evidence has shown that Vitamin E may be protective in chemotherapy-induced peripheral neuropathy. The aim of this study is to evaluate the effect of Vitamin E administration on prevention of oxaliplatin-induced peripheral neuropathy in patients with colorectal cancer. Methods: This was a prospective randomized, controlled clinical trial. Patients with colorectal cancer and scheduled to receive oxaliplatin-based regimens were enrolled in this study. Enrolled patients were randomized into two groups. The first group received Vitamin E at a dose of 400 mg daily and the second group observed, until after the sixth course of the oxaliplatin regimen. For oxaliplatin-induced peripheral neuropathy assessment, we used the symptom experience diary questionnaire that completed at baseline and after the sixth course of chemotherapy. Only patients with a score of zero at baseline were eligible for this study. Results: Thirty-two patients were randomized to the Vitamin E group and 33 to the control group. There was no difference in the mean peripheral neuropathy score changes (after − before) between two groups, after sixth course of the oxaliplatin base regimen (mean difference [after − before] of Vitamin E group = 6.37 ± 2.85, control group = 6.57 ± 2.94; P = 0.78). Peripheral neuropathy scores were significantly increased after intervention compared with a base line in each group (P < 0.001). Conclusions: The results from this current trial demonstrate a lack of benefit for Vitamin E in preventing oxaliplatin-induced peripheral neuropathy. PMID:26682028

  2. Active control of tensegrity structures under random excitation

    NASA Astrophysics Data System (ADS)

    Ganesh Raja, M.; Narayanan, S.

    2007-06-01

    In this paper we consider vibration control of tensegrity structures under stationary and nonstationary random excitations. These excitations may be representative of many physical loading conditions, such as earthquake, wind, aerodynamic and acoustic excitations. The optimal control theory based on H2 and \\mathrm {H}_{\\infty } controller with full state and limited state feedback is used for the control. The response of the tensegrity structure is represented by the zero lag covariance matrix and the same is obtained by solving the matrix Lyapunov equation. The force generated by the electro-mechanical coupling of the piezoelectric actuator is used in the formulation. A tensegrity structure of class-1 comprising of two modules, with 24 pretension cables and six struts with piezoelectric actuators, is considered.

  3. Brief Cognitive-Behavioral and Relaxation Training Interventions for Breast Cancer: A Randomized Controlled Trial

    PubMed Central

    Gudenkauf, Lisa M.; Antoni, Michael H.; Stagl, Jamie M.; Lechner, Suzanne C.; Jutagir, Devika R.; Bouchard, Laura C.; Blomberg, Bonnie B.; Glück, Stefan; Derhagopian, Robert P.; Giron, Gladys L.; Avisar, Eli; Torres-Salichs, Manuel A.; Carver, Charles S.

    2015-01-01

    Objective Women with breast cancer (BCa) report elevated distress post-surgery. Group-based cognitive-behavioral stress management (CBSM) following surgery improves psychological adaptation, though its key mechanisms remain speculative. This randomized controlled dismantling trial compared two interventions featuring elements thought to drive CBSM effects: a 5-week Cognitive-Behavioral Training (CBT) and 5-week Relaxation Training (RT) vs. a 5-week Health Education (HE) control group. Method Women with stage 0-III BCa (N = 183) were randomized to CBT, RT, or HE condition 2–10 weeks post-surgery. Psychosocial measures were collected at baseline (T1) and post-intervention (T2). Repeated-measures ANOVAs tested whether CBT and RT treatments improved primary measures of psychological adaptation and secondary measures of stress management resource perceptions from pre- to post-intervention relative to HE. Results Both CBT and RT groups reported reduced depressive affect. The CBT group reported improved emotional well-being/quality of life and less cancer-specific thought intrusions. The RT group reported improvements on illness-related social disruption. Regarding stress management resources, the CBT group reported increased reliability of social support networks, while the RT group reported increased confidence in relaxation skills. Psychological adaptation and stress management resource constructs were unchanged in the HE control group. Conclusions Non-metastatic breast cancer patients participating in two forms of brief, 5-week group-based stress management intervention after surgery showed improvements in psychological adaptation and stress management resources compared to an attention-matched control group. Findings provide preliminary support suggesting that using brief group-based stress management interventions may promote adaptation among non-metastatic breast cancer patients. PMID:25939017

  4. Promoting walking as an adjunct intervention to group cognitive behavioral therapy for anxiety disorders--a pilot group randomized trial.

    PubMed

    Merom, Dafna; Phongsavan, Philayrath; Wagner, Renate; Chey, Tien; Marnane, Claire; Steel, Zachary; Silove, Derrick; Bauman, Adrian

    2008-08-01

    A group randomized trial of adding a home-based walking program to a standard group cognitive behavioral therapy (GCBT+EX) was compared with groups receiving GCBT and educational sessions (GCBT+ED). The study was implemented in an outpatient clinic providing GCBT for clients diagnosed with panic disorder, generalized anxiety disorder or social phobia. Pre- and post-treatment measures included the self-report depression, anxiety, and stress scale (DASS-21) and measures of physical activity. From January 2004 to May 2005, six groups were allocated to GCBT+EX (n=38) and five to GCBT+ED (n=36). Analysis of covariance for completed cases (GCBT+EX, n=21; GCBT+ED, n=20), adjusting for the group design, baseline DASS-21 scores, and anxiety diagnosis showed significant effect for GCBT+EX on depression, anxiety, and stress (regression coefficients=-6.21, -3.41, and -5.14, respectively, p<0.05) compared to the GCBT+ED. The potential of exercise interventions as adjunct to GCBT for anxiety disorder needs to be further explored. PMID:17988832

  5. Randomly Sampled-Data Control Systems. Ph.D. Thesis

    NASA Technical Reports Server (NTRS)

    Han, Kuoruey

    1990-01-01

    The purpose is to solve the Linear Quadratic Regulator (LQR) problem with random time sampling. Such a sampling scheme may arise from imperfect instrumentation as in the case of sampling jitter. It can also model the stochastic information exchange among decentralized controllers to name just a few. A practical suboptimal controller is proposed with the nice property of mean square stability. The proposed controller is suboptimal in the sense that the control structure is limited to be linear. Because of i. i. d. assumption, this does not seem unreasonable. Once the control structure is fixed, the stochastic discrete optimal control problem is transformed into an equivalent deterministic optimal control problem with dynamics described by the matrix difference equation. The N-horizon control problem is solved using the Lagrange's multiplier method. The infinite horizon control problem is formulated as a classical minimization problem. Assuming existence of solution to the minimization problem, the total system is shown to be mean square stable under certain observability conditions. Computer simulations are performed to illustrate these conditions.

  6. Zinc supplementation for the treatment of severe pneumonia in hospitalized children: A randomized controlled trial

    PubMed Central

    Shehzad, Nazia; Anwar, Muhammd Irfan; Muqaddas, Tahira

    2015-01-01

    The objectives of this randomized controlled trial (RCT) were to compare the mean duration of hospital stay and mean time to relieve severe pneumonia signs and symptoms with or without zinc supplementation in hospitalized young children. This RCT was conducted from Oct 2011 to Mar 2012. in the paediatric department, PGM/Lahore General Hospital. Three hundred children (150 in each group) were randomly allocated to two groups: group A received zinc syrup (20 mg/day q 12 hourly) till discharge and group B received placebo syrup. This in addition to the antibiotic treatment. Data for severe pneumonia signs and symptoms i.e. oxygen saturation, respiratory rate, temperature and chest indrawing were recorded. The mean age of participants was 16.65+4.23 months in Group-A and15.96+5.11 months in Group-B. We found that the mean duration to relieve severe pneumonia signs and symptoms was 44.62+2.56 hours in Group-A and 48.73+3.124 hours in Group-B (p-value 0.023).Duration of hospital stay was 128.31+3.71 hours in Group-A and 137.67+2.56 in Group-B (p-value 0.001). We conclude that zinc supplementation for the treatment of children with pneumonia is an effective therapy along with standard treatment.

  7. 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. PMID:11607948

  8. Randomized controlled trial: Moxibustion and acupuncture for the treatment of Crohn’s disease

    PubMed Central

    Bao, Chun-Hui; Zhao, Ji-Meng; Liu, Hui-Rong; Lu, Yuan; Zhu, Yi-Fang; Shi, Yin; Weng, Zhi-Jun; Feng, Hui; Guan, Xin; Li, Jing; Chen, Wei-Feng; Wu, Lu-Yi; Jin, Xiao-Ming; Dou, Chuan-Zi; Wu, Huan-Gan

    2014-01-01

    AIM: To evaluate the clinical efficacy and safety of acupuncture and moxibustion for the treatment of active Crohn’s disease (CD). METHODS: Ninety-two patients were equally and randomly divided into the treatment group and received herb-partitioned moxibustion combined with acupuncture, and the control group received wheat bran-partitioned moxibustion combined with superficial acupuncture. The patients received three treatment sessions per week for 12 wk and were followed up for 24 wk. The main outcome was evaluated using the CD Activity Index (CDAI) score, and the secondary outcomes were evaluated using laboratory indicators such as hemoglobin (HGB), C-reactive protein (CRP), erythrocyte sedimentation rate, quality-of-life, endoscopic ratings, and intestinal histology scores. RESULTS: The CDAI scores of both the treatment and control groups were significantly reduced after treatment compared with those measured before treatment. However, the degree of improvement in the treatment group was significantly greater than that of the control group. The improvement in symptoms in patients of the treatment group was sustained at follow-up, whereas that of the control group was not. The overall efficacy of the treatment was significantly greater than that of the control. Both groups demonstrated significant improvements in quality-of-life ratings after treatment, but the improvement was significantly greater in the treatment group than in the control group. In addition, the patients in the treatment group showed significantly increased HGB and significantly decreased CRP levels and histopathological scores at the end of treatment, whereas the control group did not exhibit significant changes. CONCLUSION: Moxibustion with acupuncture provided significant therapeutic benefits in patients with active CD beyond the placebo effect and is therefore an effective and safe treatment for active CD. PMID:25152604

  9. Needle catheter jejunostomy: a controlled, prospective, randomized trial in patients with gynecologic malignancy.

    PubMed

    Spirtos, N M; Ballon, S C

    1988-06-01

    Sixty patients with gynecologic cancer entered a prospective, randomized study of immediate postoperative feeding. Thirty-three women in the study group received an elemental diet (Vivonex HN) delivered through a needle catheter jejunostomy. Twenty-seven patients in the control group were given standard 5% dextrose and electrolyte solutions. Patients in both groups were stratified according to nutritional status as determined by anthropometric evaluation and levels of serum albumin, total protein, and transferrin. These parameters also were measured at intervals throughout the study. Only one catheter-related complication occurred. Patients in the study group received significantly more calories (p = 0.01) and were better able to maintain serum levels of transferrin (p = 0.05) than those in the control group. An elemental diet administered through the needle catheter jejunostomy effectively maintains postoperative nutrition and is associated with few complications. PMID:3132853

  10. Striving for group agency: threat to personal control increases the attractiveness of agentic groups

    PubMed Central

    Stollberg, Janine; Fritsche, Immo; Bäcker, Anna

    2015-01-01

    When their sense of personal control is threatened people try to restore perceived control through the social self. We propose that it is the perceived agency of ingroups that provides the self with a sense of control. In three experiments, we for the first time tested the hypothesis that threat to personal control increases the attractiveness of being part or joining those groups that are perceived as coherent entities engaging in coordinated group goal pursuit (agentic groups) but not of those groups whose agency is perceived to be low. Consistent with this hypothesis we found in Study 1 (N = 93) that threat to personal control increased ingroup identification only with task groups, but not with less agentic types of ingroups that were made salient simultaneously. Furthermore, personal control threat increased a sense of collective control and support within the task group, mediated through task-group identification (indirect effects). Turning to groups people are not (yet) part of, Study 2 (N = 47) showed that personal control threat increased relative attractiveness ratings of small groups as possible future ingroups only when the relative agency of small groups was perceived to be high. Perceived group homogeneity or social power did not moderate the effect. Study 3 (N = 78) replicated the moderating role of perceived group agency for attractiveness ratings of entitative groups, whereas perceived group status did not moderate the effect. These findings extend previous research on group-based control, showing that perceived agency accounts for group-based responses to threatened control. PMID:26074832

  11. External and Turbomachinery Flow Control Working Group

    NASA Technical Reports Server (NTRS)

    Ahmadi, G.; Alstrom, B.; Colonius, T.; Dannenhoffer, J.; Glauser, M.; Helenbrook, B.; Higuchi, H.; Hodson, H.; Jha, R.; Kabiri, P.; LaGraff, J.; Low,K.; McKeon, B.; Morrison, J.; Obcid, S.; Orbaker, A.; Samimy, M.; Schmit, R.; Seifert, A.; Seume, J.; Shahabi, A.; Shea, P.; Ukeiley, L.; Wallace, R.

    2010-01-01

    Broad Flow Control Issues: a) Understanding flow physics. b) Specific control objective(s). c) Actuation. d) Sensors. e) Integrated active flow control system. f) Development of design tools (CFD, reduced order models, controller design, understanding and utilizing instabilities and other mechanisms, e.g., streamwise vorticity).

  12. Effects of warm acupuncture on breast cancer–related chronic lymphedema: a randomized controlled trial

    PubMed Central

    Yao, C.; Xu, Y.; Chen, L.; Jiang, H.; Ki, C.S.; Byun, J.S.; Bian, W.

    2016-01-01

    Background Effective treatment for breast cancer–related chronic lymphedema (bcrl) remains a clinical challenge. Acupuncture and moxibustion treatments have been shown to be beneficial and safe for treating bcrl. In the present randomized controlled trial, we compared the effectiveness of combined acupuncture and moxibustion (“warm acupuncture”) with that of diosmin in bcrl. Methods Breast cancer patients who met the inclusion and exclusion criteria (n = 30) were randomized to experimental and control groups (15 per group). On alternate days, patients in the experimental group received 30 minutes of acupuncture at 6 acupoints, with 3 of the needles each being topped by a 3-cm moxa stick. The control treatment was diosmin 900 mg 3 times daily. The control and experimental treatments were administered for 30 days. Outcome measures included arm circumferences (index of effectiveness), range of motion [rom (shoulder joint function)], quality of life, clinical safety, and adverse events. Results Measured by the index of effectiveness, bcrl improved by 51.46% in the experimental group and by 26.27% in the control group (p < 0.00001). Effects were greatest at 10 cm above the elbow and at the wrist, where the warm needling was provided. Impairments in shoulder joint rom were minimal at baseline in both treatment groups. However, the roms of rear protraction, abduction, intorsion, and extorsion in the experimental group improved significantly; they did not change in the control group. Self-reported quality of life was significantly better with warm acupuncture than with diosmin. No adverse effects were reported during the treatment period, and laboratory examinations for clinical safety fell within the normal ranges. Conclusions Compared with diosmin, warm acupuncture treatment can effectively reduce the degree of bcrl at the specific acupoints treated and can promote quality of life. Warm acupuncture showed good clinical safety, without any adverse effects on blood

  13. Hypnosis as a treatment of chronic widespread pain in general practice: A randomized controlled pilot trial

    PubMed Central

    Grøndahl, Jan Robert; Rosvold, Elin Olaug

    2008-01-01

    Background Hypnosis treatment in general practice is a rather new concept. This pilot study was performed to evaluate the effect of a standardized hypnosis treatment used in general practice for patients with chronic widespread pain (CWP). Methods The study was designed as a randomized control group-controlled study. Sixteen patients were randomized into a treatment group or a control group, each constituting eight patients. Seven patients in the treatment group completed the schedule. After the control period, five of the patients in the control group also received treatment, making a total of 12 patients having completed the treatment sessions. The intervention group went through a standardized hypnosis treatment with ten consecutive therapeutic sessions once a week, each lasting for about 30 minutes, focusing on ego-strengthening, relaxation, releasing muscular tension and increasing self-efficacy. A questionnaire was developed in order to calibrate the symptoms before and after the 10 weeks period, and the results were interpolated into a scale from 0 to 100, increasing numbers representing increasing suffering. Data were analyzed by means of T-tests. Results The treatment group improved from their symptoms, (change from 62.5 to 55.4), while the control group deteriorated, (change from 37.2 to 45.1), (p = 0,045). The 12 patients who completed the treatment showed a mean improvement from 51.5 to 41.6. (p = 0,046). One year later the corresponding result was 41.3, indicating a persisting improvement. Conclusion The study indicates that hypnosis treatment may have a positive effect on pain and quality of life for patients with chronic muscular pain. Considering the limited number of patients, more studies should be conducted to confirm the results. Trial Registration The study was registered in ClinicalTrials.gov and released 27.08.07 Reg nr NCT00521807 Approval Number: 05032001. PMID:18801190

  14. Hyperbaric treatment for children with autism: a multicenter, randomized, double-blind, controlled trial

    PubMed Central

    Rossignol, Daniel A; Rossignol, Lanier W; Smith, Scott; Schneider, Cindy; Logerquist, Sally; Usman, Anju; Neubrander, Jim; Madren, Eric M; Hintz, Gregg; Grushkin, Barry; Mumper, Elizabeth A

    2009-01-01

    Background Several uncontrolled studies of hyperbaric treatment in children with autism have reported clinical improvements; however, this treatment has not been evaluated to date with a controlled study. We performed a multicenter, randomized, double-blind, controlled trial to assess the efficacy of hyperbaric treatment in children with autism. Methods 62 children with autism recruited from 6 centers, ages 2–7 years (mean 4.92 ± 1.21), were randomly assigned to 40 hourly treatments of either hyperbaric treatment at 1.3 atmosphere (atm) and 24% oxygen ("treatment group", n = 33) or slightly pressurized room air at 1.03 atm and 21% oxygen ("control group", n = 29). Outcome measures included Clinical Global Impression (CGI) scale, Aberrant Behavior Checklist (ABC), and Autism Treatment Evaluation Checklist (ATEC). Results After 40 sessions, mean physician CGI scores significantly improved in the treatment group compared to controls in overall functioning (p = 0.0008), receptive language (p < 0.0001), social interaction (p = 0.0473), and eye contact (p = 0.0102); 9/30 children (30%) in the treatment group were rated as "very much improved" or "much improved" compared to 2/26 (8%) of controls (p = 0.0471); 24/30 (80%) in the treatment group improved compared to 10/26 (38%) of controls (p = 0.0024). Mean parental CGI scores significantly improved in the treatment group compared to controls in overall functioning (p = 0.0336), receptive language (p = 0.0168), and eye contact (p = 0.0322). On the ABC, significant improvements were observed in the treatment group in total score, irritability, stereotypy, hyperactivity, and speech (p < 0.03 for each), but not in the control group. In the treatment group compared to the control group, mean changes on the ABC total score and subscales were similar except a greater number of children improved in irritability (p = 0.0311). On the ATEC, sensory/cognitive awareness significantly improved (p = 0.0367) in the treatment group

  15. Systemic corticosteroid monotherapy for clinically diagnosed acute rhinosinusitis: a randomized controlled trial

    PubMed Central

    Venekamp, Roderick P.; Bonten, Marc J.M.; Rovers, Maroeska M.; Verheij, Theo J.M.; Sachs, Alfred P.E.

    2012-01-01

    Background: Patients with acute rhinosinusitis are frequently encountered in primary care. Although corticosteroids are being increasingly used for symptom control, evidence supporting their use is inconclusive. We conducted a randomized controlled trial to examine the effectiveness of systemic corticosteroid monotherapy for clinically diagnosed, uncomplicated acute rhinosinusitis. Methods: We conducted a block-randomized, double-blind, placebo-controlled clinical trial at 54 primary care practices (68 family physicians) in the Netherlands between Dec. 30, 2008, and Apr. 28, 2011. Adult patients with clinically diagnosed acute rhinosinusitis were randomly assigned to receive either prednisolone 30 mg/d or placebo for 7 days and asked to complete a symptom diary for 14 days. The primary outcome measure was the proportion of patients with resolution of facial pain or pressure on day 7. Results: Of the 185 patients included in the trial (93 in the treatment group, 92 in the placebo group), 2 withdrew from the study and 9 were excluded from the primary analysis because of incomplete symptom reporting. The remaining 174 patients (88 in the treatment group, 86 in the placebo group) were included in the intention-to-treat analysis. The proportions of patients with resolution of facial pain or pressure on day 7 were 62.5% (55/88) in the prednisolone group and 55.8% (48/86) in the placebo group (absolute risk difference 6.7%, 95% confidence interval −7.9% to 21.2%). The groups were similar with regard to the decrease over time in the proportion of patients with total symptoms (combined symptoms of runny nose, postnasal discharge, nasal congestion, cough and facial pain) and health-related quality of life. Adverse events were mild and did not differ significantly between the groups. Interpretation: Systemic corticosteroid monotherapy had no clinically relevant beneficial effects among patients with clinically diagnosed acute rhinosinusitis. Netherlands Trial Register

  16. Effects of kettlebell training on postural coordination and jump performance: a randomized controlled trial.

    PubMed

    Jay, Kenneth; Jakobsen, Markus D; Sundstrup, Emil; Skotte, Jørgen H; Jørgensen, Marie B; Andersen, Christoffer H; Pedersen, Mogens T; Andersen, Lars L

    2013-05-01

    The aim of this study was to investigate the effectiveness of a worksite intervention using kettlebell training to improve postural reactions to perturbation and jump performance. This single-blind randomized controlled trial involved 40 adults (n = 40) from occupations with a high prevalence of musculoskeletal pain and discomfort (mean age 44 years, body mass index 23 kg·m, 85% women). A blinded examiner took measures at baseline and follow-up. Participants were randomly assigned to a training group-doing kettlebell swings 3 times a week for 8 weeks-or to a control group. The outcome measures were postural reactions to sudden perturbation and maximal countermovement jump height. Compared with the control group, the training group had a significant decreased stopping time after perturbation (-109 ms, 95% confidence interval [-196 to -21]). Jump height increased significantly in the training group (1.5 cm, 95% confidence interval [0.5 to 2.5]), but this was nonsignificantly different from control. Kettlebell training improves postural reactions to sudden perturbation. Future studies should investigate whether kettlebell training can reduce the risk of low back injury in occupations with manual material handling or patient handling where sudden perturbations often occur. PMID:22843044

  17. Localized Piezoelectric Alveolar Decortication for Orthodontic Treatment in Adults: A Randomized Controlled Trial.

    PubMed

    Charavet, C; Lecloux, G; Bruwier, A; Rompen, E; Maes, N; Limme, M; Lambert, F

    2016-08-01

    This randomized controlled trial aimed to evaluate the benefits and clinical outcomes of piezocision, which is a minimally invasive approach to corticotomy that is used in orthodontic treatments. Twenty-four adult patients presenting with mild overcrowdings were randomly allocated to either a control group that was treated with conventional orthodontics or a test group that received piezo-assisted orthodontics. The piezocisions were performed 1 wk week after the placement of the orthodontic appliances. Neither grafting material nor sutures were used. All patients were followed every 2 wk, and archwires were changed only when they were no longer active. The periods required for the completion of the overall orthodontic treatments were calculated, and the periodontal parameters were evaluated at baseline and at the end of the orthodontic treatment. Patient-centered outcomes were assessed with a visual analog scale; analgesic use following the procedures was also recorded. The patient characteristics were similar between the 2 groups. The overall treatment time was significantly reduced by 43% in the piezocision group as compared with the control group. In both groups, periodontal parameters (i.e., recession depth, pocket depth, plaque index, and papilla bleeding index) remained unchanged between the baseline and treatment completion time points. No increase in root resorption was observed in either group. Scars were observed in 50% of the patients in the piezocision group. Analgesic consumption was similar following orthodontic appliance placement and piezocision surgery. Patient satisfaction was significantly better in the piezocision group than in the control group. In these conditions, the piezocision technique seemed to be effective in accelerating orthodontic tooth movement. No gingival recessions were observed. The risk of residual scars might limit the indications for piezocision in patients with a high smile line (ClinicalTrials.gov NCT02590835). PMID

  18. The Deckled Incision: Study Protocol for a Randomized Controlled Trial

    PubMed Central

    Lord, Sarah J; Ngo, Quan

    2016-01-01

    Background Scar visibility is multifactorial and skin closure technique is thought to play an important role. It is an established principle in plastic surgery that Z plasties generally reduce scar contracture by breaking up the lines of tension in a wound. As an extension of this principle, it is postulated that irregular “deckled” skin incisions made during tumor excision would produce aesthetically superior scars. Objective The primary objective of this study is to assess both the clinician and patient opinion of scar quality using the Patient and Observer Scar Assessment Scale (POSAS). Secondary objectives include the proportion of scars judged as good by the both the patient and clinician (less than or equal to 5 on the overall PSOAS scale), the number of adverse events, and the proportion of the scar visible at 1 meter. Methods The deckling study will be a patient-blinded, simple randomized controlled trial (RCT) at a single center institution. The two groups will be equally allocated on a 1:1 ratio into the control and treatment arms. All patients greater than 18 years of age undergoing a plastic surgery procedure involving excision of skin lesions will be enrolled. Any patients requiring re-excision through the wound or undergoing injectable corticosteroid therapy will be excluded. A total of 500 patients will be enrolled. The patients will be followed-up at 1 week, 3 months, and 6 months post-operatively. Results The study is expected to begin enrolment in August 2016. We anticipate that the deckling study group will have superior scar outcomes when compared to the straight line incision. From clinical experience this is especially true for lesions involving the face and in those areas of the skin that have undergone radiation therapy. The study will be funded by the Plastics and Reconstructive Surgery Department at St Vincent’s Hospital, Sydney, Australia. Ethics approval has been obtained for the study. Conclusion: We believe this will be an

  19. Efficacy of nifedipine and alfuzosin in the management of distal ureteric stones: A randomized, controlled study

    PubMed Central

    Sameer; Lal, Shyam; Charak, K. S.; Chakravarti, Sumit; Kohli, Supreeti; Ahmad, Shamshad

    2014-01-01

    Introduction: Stone disease is a significant and world-wide health problem. Recently, certain drugs have been used as a supplement to observation alone in an effort to improve spontaneous stone expulsion. We evaluated the efficacy of nifedipine and alfuzosin in the medical treatment of symptomatic, uncomplicated distal ureteral stones. Materials and Methods: This was a randomized controlled prospective study to determine the efficacy of alfuzosin and nifedipine as an adjunctive medical therapy, to increases the stone-expulsion rates in distal ureteric calculus of size ≤10 mm. Investigators and patients were blinded to the randomization scheme. Patients were randomly divided into three equal groups of 35 patients each. Patients in Group I received tablet nifedipine 30 mg/day, Group II received alfuzosin 10 mg/day and Group III was the control group received tablet diclofenac sodium. The patient blood pressure, stone position on imaging, number of pain attacks, time of stone-expulsion, hospital re-admission and any adverse events were assessed. Patients were followed-up weekly and continued until the patient was rendered stone free or up to 28 days. Statistical analysis was performed and P < 0.05 was considered to be significant. Results: Stone-expulsion was observed in 60%, 85.7% and 20% patients in Group I, II and III respectively. A statistically significant difference was noted in between Groups I versus III, Groups II versus III and Groups I versus II (P < 0.0001, P < 0.0001, and P < 0.0315 respectively). The mean number of pain attacks was 2.91 ± 1.01 for Group I, 1.8 ± 0.83 for Group II, and 2.82 ± 1.12 for Group III, which is statistical significant in Groups II versus III, and Groups I versus II (P < 0.001 and P < 0.001). Hospital re-admission rate was less in treatment groups when compare to control group (P < 0.0001). Conclusion: The use of alfuzosin and nifedipine as a medical expulsive therapy for distal ureteric stones proved to be safe and

  20. Using Internet and Mobile Phone Technology to Deliver an Automated Physical Activity Program: Randomized Controlled Trial

    PubMed Central

    Catt, Michael; De Boni, Marco; Fairley, Bruce William; Hurst, Tina; Murray, Peter; Richardson, Alannah; Sodhi, Jaspreet Singh

    2007-01-01

    Background The Internet has potential as a medium for health behavior change programs, but no controlled studies have yet evaluated the impact of a fully automated physical activity intervention over several months with real-time objective feedback from a monitor. Objective The aim was to evaluate the impact of a physical activity program based on the Internet and mobile phone technology provided to individuals for 9 weeks. Methods A single-center, randomized, stratified controlled trial was conducted from September to December 2005 in Bedfordshire, United Kingdom, with 77 healthy adults whose mean age was 40.4 years (SD = 7.6) and mean body mass index was 26.3 (SD = 3.4). Participants were randomized to a test group that had access to an Internet and mobile phone–based physical activity program (n = 47) or to a control group (n = 30) that received no support. The test group received tailored solutions for perceived barriers, a schedule to plan weekly exercise sessions with mobile phone and email reminders, a message board to share their experiences with others, and feedback on their level of physical activity. Both groups were issued a wrist-worn accelerometer to monitor their level of physical activity; only the test group received real-time feedback via the Internet. The main outcome measures were accelerometer data and self-report of physical activity. Results At the end of the study period, the test group reported a significantly greater increase over baseline than did the control group for perceived control (P < .001) and intention/expectation to exercise (P < .001). Intent-to-treat analyses of both the accelerometer data (P = .02) and leisure time self-report data (P = .03) found a higher level of moderate physical activity in the test group. The average increase (over the control group) in accelerometer-measured moderate physical activity was 2 h 18 min per week. The test group also lost more percent body fat than the control group (test group: −2

  1. Dynamics and controls working group summary

    NASA Technical Reports Server (NTRS)

    Oglevie, R. E.

    1984-01-01

    The technology status of the dynamics and controls discipline as it applies to energy storage wheel systems was evaluated. No problems were identified for which an adequate solution could not be proposed. Design issues that influence control were addressed. The dynamics and control aspects associated with the energy storage system concept and its various constituent parts, and the control tasks attendant to large, manned spacecraft are discussed.

  2. Cervical Lidocaine for IUD Insertional Pain: a Randomized Controlled Trial

    PubMed Central

    McNicholas, Colleen P.; Madden, Tessa; Zhao, Qiuhong; Secura, Gina; Allsworth, Jenifer E.; Peipert, Jeffrey F.

    2012-01-01

    Objective Anticipated pain with intrauterine device (IUD) insertion may be a barrier to widespread use. Our objective was to evaluate the efficacy of intracervical 2% lidocaine gel for pain relief with IUD insertion. Study Design We performed a double-blind, randomized controlled trial of women undergoing IUD insertion. Participants were randomly assigned to 2% lidocaine or placebo gel. Study gel (3ccs) wase placed 3 minutes prior to IUD insertion. Pain scores were measured at various time points using a 10-point visual analog scale. Results Of the 200 participants randomized, 199 completed the study. Pain scores among lidocaine and placebo arms were similar at tenaculum placement (lidocaine and placebo; median 4, range 0–10 p=0.15) as well as with insertion (lidocaine: median 5 range 1–10, placebo: median 6 range 0–10 p=0.16). These results did not differ by parity. Conclusions Topical or intracervical 2% lidocaine gel prior to IUD insertion does not decrease pain scores. PMID:23107081

  3. Shallow Semantic Parsing of Randomized Controlled Trial Reports

    PubMed Central

    Paek, Hyung; Kogan, Yacov; Thomas, Prem; Codish, Seymour; Krauthammer, Michael

    2006-01-01

    In this work, we are measuring the performance of Propbank-based Machine Learning (ML) for automatically annotating abstracts of Randomized Controlled Trials (RCTs) with semantically meaningful tags. Propbank is a resource of annotated sentences from the Wall Street Journal (WSJ) corpus, and we were interested in assessing performance issues when porting this resource to the medical domain. We compare intra-domain (WSJ/WSJ) with cross-domain (WSJ/medical abstracts) performance. Although the intra-domain performance is superior, we found a reasonable cross-domain performance. PMID:17238412

  4. Neighborhood Effects in a Behavioral Randomized Controlled Trial

    PubMed Central

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

    2015-01-01

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

  5. Group cognitive-behavioral therapy and group interpersonal psychotherapy for the nonpurging bulimic individual: a controlled comparison.

    PubMed

    Wilfley, D E; Agras, W S; Telch, C F; Rossiter, E M; Schneider, J A; Cole, A G; Sifford, L A; Raeburn, S D

    1993-04-01

    This study evaluated the effectiveness of group cognitive-behavioral treatment (CBT) and group interpersonal psychotherapy (IPT) for binge eating. Fifty-six women with nonpurging bulimia were randomly assigned to 1 of 3 groups: CBT, IPT, or a wait-list control (WL). Treatment was administered in small groups that met for 16 weekly sessions. At posttreatment, both group CBT and group IPT treatment conditions showed significant improvement in reducing binge eating, whereas the WL condition did not. Binge eating remained significantly below baseline levels for both treatment conditions at 6-month and 1-year follow-ups. These data support the central role of both eating behavior and interpersonal factors in the understanding and treatment of bulimia. PMID:8473584

  6. Sleep Education Improves the Sleep Duration of Adolescents: A Randomized Controlled Pilot Study

    PubMed Central

    Kira, Geoff; Maddison, Ralph; Hull, Michelle; Blunden, Sarah; Olds, Timothy

    2014-01-01

    Purpose: To determine the feasibility and pilot a sleep education program in New Zealand high school students. Methods: A parallel, two-arm randomized controlled pilot trial was conducted. High school students (13 to 16 years) were randomly allocated to either a classroom-based sleep education program intervention (n = 15) or to a usual curriculum control group (n = 14). The sleep education program involved four 50-minute classroom-based education sessions with interactive groups. Students completed a 7-day sleep diary, a sleep questionnaire (including sleep hygiene, knowledge and problems) at baseline, post-intervention (4 weeks) and 10 weeks follow-up. Results: An overall treatment effect was observed for weekend sleep duration (F1,24 = 5.21, p = 0.03). Participants in the intervention group slept longer during weekend nights at 5 weeks (1:37 h:min, p = 0.01) and 10 weeks: (1:32 h:min, p = 0.03) compared to those in the control group. No differences were found between groups for sleep duration on weekday nights. No significant differences were observed between groups for any of the secondary outcomes (sleep hygiene, sleep problems, or sleep knowledge). Conclusions: A sleep education program appears to increase weekend sleep duration in the short term. Although this program was feasible, most schools are under time and resource pressure, thus alternative methods of delivery should be assessed for feasibility and efficacy. Larger trials of longer duration are needed to confirm these findings and determine the sustained effect of sleep education on sleep behavior and its impact on health and psychosocial outcomes. Commentary: A commentary on this article appears in this issue on page 793. Citation: Kira G, Maddison R, Hull M, Blunden S, Olds T. Sleep education improves the sleep duration of adolescents: a randomized controlled pilot study. J Clin Sleep Med 2014;10(7):787-792. PMID:25024657

  7. Supportive Nursing Care and Satisfaction of Patients Receiving Electroconvulsive Therapy: A Randomized Controlled Clinical Trial

    PubMed Central

    Navidian, Ali; Ebrahimi, Hossein; Keykha, Roghaieh

    2015-01-01

    Background: Patient satisfaction is the most important criterion in evaluating the quality of care. Besides, its assessment in patients with severe mental disorder treated by electroconvulsive therapy (ECT) is highly appropriate. The ECT is accompanied by lower satisfaction and may exacerbate the patients’ condition. Objectives: The current study aimed to determine the effect of supportive nursing care on the satisfaction of patients receiving ECT. Patients and Methods: This randomized controlled trial was conducted in the education center of Baharan psychiatric hospital, Zahedan, Iran. Seventy hospitalized patients receiving ECT were randomly divided into two groups of control (n = 35) and intervention (n = 35).The socio-personal and Webster Satisfaction Questionnaire were used as data collection tools. The intervention group received supportive nursing care by nurses trained in informational, emotional, and physical aspects. The control group received only regular nursing care. The levels of satisfaction were measured and compared between groups, before and after the intervention. Data were analyzed using the SPSS software, and Chi-square, independent and paired t tests, as well as covariance analysis were performed. Results: The results showed similarities in socio-personal characteristics of both groups. However, there was a significant difference (P < 0.001) between the means of satisfaction in the groups, predominantly for the intervention group. In other words, a significant difference (P < 0.001) was observed between the means of satisfaction of the intervention (54.71 ± 5.27) and control (36.28 ± 7.00) groups after intervention by controlling the effect of socio-personal variables. Conclusions: Results of the current study confirmed the effect of supportive nursing care on increasing the level of satisfaction in ECT receiving patients, recommending the use of this therapeutic method. PMID:26473077

  8. Ultrasound-Guided Pulsed Radiofrequency for Carpal Tunnel Syndrome: A Single-Blinded Randomized Controlled Study

    PubMed Central

    2015-01-01

    Objective We assessed the therapeutic efficiency of ultrasound-guided pulsed radiofrequency (PRF) treatment of the median nerve in patients with carpal tunnel syndrome (CTS). Methods We conducted a prospective, randomized, controlled, single-blinded study. Forty-four patients with CTS were randomized into intervention or control groups. Patients in the intervention group were treated with PRF and night splint, and the control group was prescribed night splint alone. Primary outcome was the onset time of significant pain relief assessed using the visual analog scale (VAS), and secondary outcomes included evaluation of the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) results, cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity (SNCV) of the median nerve, and finger pinch strength. All outcome measurements were performed at 1, 4, 8, and 12 weeks after treatment. Results Thirty-six patients completed the study. The onset time of pain relief in the intervention group was significantly shorter (median onset time of 2 days vs. 14 days; hazard ratio = 7.37; 95% CI, 3.04–17.87) compared to the control group (p < 0.001). Significant improvement in VAS and BCTQ scores (p < 0.05) was detected in the intervention group at all follow-up periods compared to the controls (except for the severity subscale of BCTQ at week 1). Ultrasound-guided PRF treatment resulted in a lower VAS score and stronger finger pinch compared to the control group over the entire study. Conclusions Our study shows that ultrasound-guided PRF serves as a better approach for pain relief in patients with CTS. Trial Registration ClinicalTrials.gov NCT02217293 PMID:26067628

  9. The effect of Neuragen PN® on Neuropathic pain: A randomized, double blind, placebo controlled clinical trial

    PubMed Central

    2010-01-01

    Background A double blind, randomized, placebo controlled study to evaluate the safety and efficacy of the naturally derived topical oil, "Neuragen PN®" for the treatment of neuropathic pain. Methods Sixty participants with plantar cutaneous (foot sole) pain due to all cause peripheral neuropathy were recruited from the community. Each subject was randomly assigned to receive one of two treatments (Neuragen PN® or placebo) per week in a crossover design. The primary outcome measure was acute spontaneous pain level as reported on a visual analog scale. Results There was an overall pain reduction for both treatments from pre to post application. As compared to the placebo, Neuragen PN® led to significantly (p < .05) greater pain reduction. Fifty six of sixty subjects (93.3%) receiving Neuragen PN® reported pain reduction within 30 minutes. This reduction within 30 minutes occurred in only twenty one of sixty (35.0%) subjects receiving the placebo. In a break out analysis of the diabetic only subgroup, 94% of subjects in the Neuragen PN® group achieved pain reduction within 30 minutes vs 11.0% of the placebo group. No adverse events were observed. Conclusions This randomized, placebo controlled, clinical trial with crossover design revealed that the naturally derived oil, Neuragen PN®, provided significant relief from neuropathic pain in an all cause neuropathy group. Participants with diabetes within this group experienced similar pain relief. Trial registration ISRCTN registered: ISRCTN13226601 PMID:20487567

  10. Perioperative Continuous Ropivacaine Wound Infusion in Laparoscopic Cholecystectomy: A Randomized Controlled Double-blind Trial.

    PubMed

    Fassoulaki, Argyro; Vassi, Emilia; Korkolis, Dimitrios; Zotou, Marianna

    2016-02-01

    Wound infusion with local anesthetics has been used for postoperative pain relief with variable results. This randomized, controlled, double-blind clinical trial examines the effect of ropivacaine infusion on pain after laparoscopic cholecystectomy. A total of 110 patients were randomly assigned to 2 groups. After induction of anesthesia a 75-mm catheter was inserted subcutaneously and connected to an elastomeric pump containing either 0.75% ropivacaine (ropivacaine group) or normal saline (control group) for 24 hours postoperatively. Before skin closure, each hole was infiltrated with 2 mL of 0.75% ropivacaine or normal saline according to randomization. Pain at rest, pain during cough, and analgesic consumption were recorded in the postanesthesia care unit and at 2, 4, 8, 24, and 48 hours postoperatively. Analgesic requirements and pain scores were recorded 1 and 3 months after surgery. The ropivacaine group reported less pain during cough (P=0.044) in the postanesthesia care unit (P=0.017) and 4 hours postoperatively (P=0.038). Ropivacaine wound infusion had no effect on late and chronic pain. PMID:26679680

  11. Effect of pravastatin on survival in patients with advanced hepatocellular carcinoma. A randomized controlled trial

    PubMed Central

    Kawata, S; Yamasaki, E; Nagase, T; Inui, Y; Ito, N; Matsuda, Y; Inada, M; Tamura, S; Noda, S; Imai, Y; Matsuzawa, Y

    2001-01-01

    Chemotherapy is not effective for hepatocellular carcinoma (HCC). HMG-CoA redutase inhibitors have cytostatic activity for cancer cells, but their clinical usefulness is unknown. To investigate whether pravastatin, a potent HMG-CoA reductase inhibitor, prolongs survival in patients with advanced HCC, this randomized controlled trial was conducted between February 1990 and February 1998 at Osaka University Hospital. 91 consecutive patients <71 years old (mean age 62) with unresectable HCC were enroled in this study. 8 patients were withdrawn because of progressive liver dysfunction; 83 patients were randomized to standard treatment with or without pravastatin. All patients underwent transcatheter arterial embolization (TAE) followed by oral 5-FU 200 mg−1d for 2 months. Patients were then randomly assigned to control (n = 42) and pravastatin (n = 41) groups. Pravastatin was administered at a daily dose of 40 mg. The effect of pravastatin on tumour growth was assessed by ultrasonography. Primary endpoint was death due to progression of HCC. The duration of pravastatin administration was 16.5 ± 9.8 months (mean ± SD). No patients in either group were lost to follow-up. Median survival was 18 months in the pravastatin group versus 9 months in controls (P = 0.006). The Cox proportional hazards model showed that pravastatin was a significant factor contributing to survival. Pravastatin prolonged the survival of patients with advanced HCC, suggesting its value for adjuvant treatment. © 2001 Cancer Research Campaign http://www.bjcancer.com PMID:11286466

  12. Tai chi improves cognitive and physical function in the elderly: a randomized controlled trial

    PubMed Central

    Sun, Jiao; Kanagawa, Katsuko; Sasaki, Junko; Ooki, Syuichi; Xu, Huali; Wang, Li

    2015-01-01

    [Purpose] To investigate the effect of Tai Chi on cognitive and physical function in the elderly. [Subjects and Methods] A randomized trial design was used. A total 150 subjects were enrolled and were divided into Tai Chi and control groups. Subjects in the Tai Chi group participated Tai Chi for 6 months, and subjects in the control group participated in other non-athletic activities. [Results] There were no differences between the groups in the one leg standing time with eyes open, left grip strength, or the Frontal Assessment Battery at bedside after 3 and 6 months of intervention. The Mini-Mental State Examination scores after 3 and 6 months were higher in the Tai Chi group than in the control group. The right grip strength after 3 months increased more in the Tai Chi group than in the control group. Both the 5-m high walking speed and 10-m normal walking speed were significantly lower after 3 and 6 months of Tai Chi practice. [Conclusion] These results suggest that regular Tai Chi practice may improve cognitive and physical function in the elderly. PMID:26157242

  13. Information without Implementation: A Practical Example for Developing a Best Practice Education Control Group.

    PubMed

    Balderson, Benjamin H; McCurry, Susan M; Vitiello, Michael V; Shortreed, Susan M; Rybarczyk, Bruce D; Keefe, Francis J; Korff, Michael Von

    2016-01-01

    This article considers methodology for developing an education-only control group and proposes a simple approach to designing rigorous and well-accepted control groups. This approach is demonstrated in a large randomized trial. The Lifestyles trial (n = 367) compared three group interventions: (a) cognitive-behavioral treatment (CBT) for osteoarthritis pain, (b) CBT for osteoarthritis pain and insomnia, and (c) education-only control (EOC). EOC emulated the interventions excluding hypothesized treatment components and controlling for nonspecific treatment effects. Results showed this approach resulted in a control group that was highly credible and acceptable to patients. This approach can be an effective and practical guide for developing high-quality control groups in trials of behavioral interventions. PMID:26485203

  14. Information without Implementation: A Practical Example for Developing a Best Practice Education Control Group

    PubMed Central

    Balderson, Benjamin H.; McCurry, Susan M.; Vitiello, Michael V.; Shortreed, Susan M.; Rybarczyk, Bruce D.; Keefe, Francis J.; Von Korff, Michael

    2015-01-01

    This paper considers methodology for developing an education only control group and proposes a simple approach to designing rigorous and well-accepted control groups. This approach is demonstrated in a large randomized trial. The Lifestyles trial (n=367) compared three group interventions: 1) cognitive-behavioral treatment (CBT) for osteoarthritis pain, 2) CBT for osteoarthritis pain and insomnia, and 3) education only control (EOC). EOC emulated the interventions excluding hypothesized treatment components and controlling for non-specific treatment effects. Results showed this approach resulted in a control group that was highly credible and acceptable to patients. This approach can be an effective and practical guide for developing high quality control groups in trials of behavioral interventions. PMID:26485203

  15. The HOPE Social Media Intervention for Global HIV Prevention: A Cluster Randomized Controlled Trial in Peru

    PubMed Central

    Young, Sean D.; Cumberland, William G.; Nianogo, Roch; Menacho, Luis A.; Galea, Jerome T.; Coates, Thomas

    2015-01-01

    Background Social media technologies are newly emerging tools that can be used for HIV prevention and testing in low- and middle-income countries, such as Peru. This study examined the efficacy of using the Harnessing Online Peer Education (HOPE) social media intervention to increase HIV testing among men who have sex with men (MSM) in Peru. Methods In a cluster randomized controlled trial with concealed allocation, Peruvian MSM from Greater Lima/Callao (N = 556) were randomly assigned to join private intervention or control groups on Facebook for 12 weeks. In the intervention condition, forty-nine Peruvian MSM were trained and randomly assigned to be HIV prevention mentors to participants via Facebook groups over 12 weeks. Control participants received an enhanced standard of care, including standard offline HIV prevention available in Peru as well as participation in Facebook groups (without peer leaders) that provided study updates and HIV testing information. After accepting a request to join the groups, continued participation was voluntary. Participants could request a free HIV test at a local community clinic, and completed questionnaires on HIV risk behaviors and social media use at baseline and 12-week follow-up. Findings Between March 19, 2012, and June 11, 2012, and Sept 26, 2012, and Dec 19, 2012, 556 participants were randomly assigned to intervention groups (N=278) or control groups (N=278); we analyse data for 252 and 246. 43 participants (17%) in the intervention group and 16 (7%) in the control groups got tested for HIV (adjusted odds ratio 2.61, 95% CI 1.55–4.38). No adverse events were reported. Retention at 12-week follow-up was 90%. Across conditions, 7 (87.5%) of the 8 participants who tested positive were linked to care at a local clinic. Interpretation Development of peer-mentored social media communities seemed to be an effective method to increase HIV testing among high-risk populations in Peru.: Results suggest that the HOPE social

  16. The prevention of depressive symptoms in rural school children: a randomized controlled trial.

    PubMed

    Roberts, Clare; Kane, Robert; Thomson, Helen; Bishop, Brian; Hart, Bret

    2003-06-01

    A controlled trial was conducted to evaluate a prevention program aimed at reducing depressive and anxious symptoms in rural school children. Seventh-grade children with elevated depression were selected. Nine primary schools (n = 90) were randomly assigned to receive the program, and 9 control schools (n = 99) received their usual health education classes. Children completed questionnaires on depression, anxiety, explanatory style, and social skills. Parents completed the Child Behavior Checklist (T. M. Achenbach, 1991). No intervention effects were found for depression. Intervention group children reported less anxiety than the control group after the program and at 6-month follow-up and more optimistic explanations at postintervention. Intervention group parents reported fewer child internalizing and externalizing symptoms at postintervention only. PMID:12795585

  17. The Efficacy of Computerized Cognitive Training in Adults With ADHD: A Randomized Controlled Trial.

    PubMed

    Stern, Adi; Malik, Elad; Pollak, Yehuda; Bonne, Omer; Maeir, Adina

    2014-04-22

    Objective: This is a randomized control trial examining the efficiency of computerized cognitive training (CCT) for adults with ADHD, comparing two training conditions with graded levels of executive cognitive demands. Method: Adults with ADHD (n = 60) were randomized into study (n = 34) and control (n = 26) groups. Training was conducted with the computerized AttenFocus program. Control group received a simple, non-hierarchical version with less executive demands. Results: Significant positive changes in symptoms ratings, ecological measures of executive functions, and occupational performance were found in both groups. No significant changes were found in variables of neurocognitive performance battery and quality of life. No significant time by group interaction effects were found. Conclusion: No benefits of the intervention were found relative to the control. Lack of interaction effects may be due to insufficient power, non-specific cognitive training or placebo effects. Results demonstrate some positive findings for general CCT, yet do not support the inclusion of specific higher level executive training. PMID:24756172

  18. Multidisciplinary rehabilitation and steroids in the management of multiple sclerosis relapses: a randomized controlled trial

    PubMed Central

    Dackovic, Jelena; Tepavcevic, Darija Kisic; Basuroski, Irena Dujmovic; Mesaros, Sarlota; Pekmezovic, Tatjana; Drulovic, Jelena

    2015-01-01

    Introduction Periodic relapses are one of the main characteristics of multiple sclerosis (MS), from which recovery is often incomplete despite high-dose methylprednisolone (HDMP) treatment. The aim of our study was to evaluate the potential benefits of short-term HDMP combined with multidisciplinary rehabilitation (MDR) in persons with MS in relapse in order to assess whether combination of steroid therapy with MDR is more beneficial than steroid therapy alone. Material and methods This investigation was conducted as a randomized controlled trial. The MS patients were eligible if they had an established diagnosis and relapse requiring application of HDMP. Forty-nine patients were included in the study and randomized to control and treatment groups, and 37 completed the study. High-dose methylprednisolone was administered to all patients. The treatment group additionally underwent an MDR program over a 3-week period. All outcome measures were completed at baseline and 1 and 3 months later. Results The Expanded Disability Status Scale (EDSS) and Functional Independence Measure (FIM) motor scores improved statistically significantly 1 month after HDMP, in both treatment and control groups. During the study period, in the treatment group, a sustained large effect size (ES) was found for both physical and mental composite scores of Multiple Sclerosis Quality of Life-54 (MSQoL-54), while in the controls, a sustained moderate ES was demonstrated only for physical composite score. Conclusions Our findings suggest that MDR improves MS relapse outcome. PMID:27186184

  19. Intravenous Versus Oral Antibiotic Prophylaxis Efficacy for Elective Laparoscopic Cholecystectomies: a Prospective Randomized Controlled Trial.

    PubMed

    Karaca, A Serdar; Gündoğdu, Haldun; Özdoğan, Mehmet; Ersoy, Eren

    2015-12-01

    The aim of the present prospective randomized controlled trial is to compare the effectiveness of intravenous and oral antibiotic prophylaxis for cost and surgical site infection in elective laparoscopic cholecystectomy. Three hundred twenty patients were split into two groups as to include 160 patients in each, and they were evaluated in a prospective and randomized fashion. While one group was subjected to 1 g cefazolin via intravenous route during anesthesia induction, other group received 1 g cephalexin monohydrate via oral route 1 h prior to the operation. Demographic findings and operation results of the patients were compared by analyses. Our 320 patients (278 females and 42 males) received elective cholecystectomy and were followed up for a period of 6-26 months. Each group had 160 patients. Both groups were similar with regard to demographic characteristics and inclusion criteria. Among all, only five (1.5 %) cases demonstrated postoperative surgical site infection. Surgical site infection at postoperative period was determined in three (1.8 %) cases of intravenous prophylaxis group and two (1.2 %) cases of oral prophylaxis group. There was no statistically significant difference between the groups in terms of surgical site infection. Oral antibiotic prophylaxis can be used in elective laparoscopic cholecystectomy prophylaxis due to its cost-effective, reliable nature, and low surgical site infection rate. PMID:26730079

  20. A group-randomized tobacco trial among 30 Pacific Northwest colleges: Results from the Campus Health Action on Tobacco study

    PubMed Central

    McLerran, Dale; Livaudais, Jennifer C.; Coronado, Gloria D.

    2010-01-01

    Introduction: We conducted a group-randomized trial to increase smoking cessation and decrease smoking onset and prevalence in 30 colleges and universities in the Pacific Northwest. Methods: Random samples of students, oversampling for freshmen, were drawn from the participating colleges; students completed a questionnaire that included seven major areas of tobacco policies and behavior. Following this baseline, the colleges were randomized to intervention or control. Three interventionists developed Campus Advisory Boards in the 15 intervention colleges and facilitated intervention activities. The freshmen cohort was resurveyed 1 and 2 years after the baseline. Two-years postrandomization, new cross-sectional samples were drawn, and students were surveyed. Results: At follow-up, we found no significant overall differences between intervention and control schools when examining smoking cessation, prevalence, or onset. There was a significant decrease in prevalence in private independent colleges, a significant increase in cessation among rural schools, and a decrease in smoking onset in urban schools. Discussion: Intervention in this college population had mixed results. More work is needed to determine how best to reach this population of smokers. PMID:20447935

  1. Enhancing antiepileptic drug adherence: a randomized controlled trial.

    PubMed

    Brown, Ian; Sheeran, Paschal; Reuber, Markus

    2009-12-01

    Suboptimal adherence to antiepileptic drug (AED) treatment is commonplace, and increases the risk of status epilepticus and sudden unexplained death in epilepsy. This randomized controlled trial was designed to demonstrate whether an implementation intention intervention involving the completion of a simple self-administered questionnaire linking the intention of taking medication with a particular time, place, and other activity can improve AED treatment schedule adherence. Of the 81 patients with epilepsy who were randomized, 69 completed a 1-month monitoring period with an objective measure of tablet taking (electronic registration of pill bottle openings, Medication Event Monitoring System [MEMS]). Intervention participants showed improved adherence relative to controls on all three outcomes: doses taken in total (93.4% vs. 79.1%), days on which correct dose was taken (88.7% vs. 65.3%), and doses taken on schedule (78.8% vs. 55.3%) (P<0.01). The implementation intention intervention may be an easy-to-administer and effective means of promoting AED adherence. PMID:19864187

  2. Testing an empowerment intervention to help parents make homes smoke-free: a randomized controlled trial.

    PubMed

    Herbert, Rosemary J; Gagnon, Anita J; O'Loughlin, Jennifer L; Rennick, Janet E

    2011-08-01

    The objective of this randomized controlled trial was to test if parents' participation in an intervention based on an empowerment ideology and participatory experiences decreased the number of cigarettes smoked in homes. Sixty families were randomized to the intervention (n = 30) or control (n = 30) group. The intervention included three weekly group sessions followed by three weekly follow-up telephone calls over six consecutive weeks. During group sessions, parents shared experiences about environmental tobacco smoke, identified personal strengths and resources, and developed action plans. Data were collected in interviewer-administered questionnaires at baseline and 6 months follow-up. Ninety-three percent of the sample consisted of mothers, 77% of whom smoked during pregnancy. Forty-two percent of the total sample reported a household income of <$15,000. The median number of cigarettes smoked in the home daily decreased from 18 to 4 in the total sample however no statistically significant difference was detected between groups at 6 months follow-up. Participation in the study, independent of group, may have resulted in parents decreasing the number of cigarettes smoked in the home. Valuable lessons were learned about recruiting and working with this group of parents, all of whom faced the challenges of tobacco and almost half of whom lived in poverty. PMID:21234793

  3. A randomized controlled trial to increase information, motivation, and behavioral skills in Ugandan adolescents

    PubMed Central

    Ybarra, Michele L.; Korchmaros, Josephine D.; Prescott, Tonya L.; Birungi, Ruth

    2015-01-01

    Background One in twenty-five Ugandan adolescents is HIV positive. Purpose Examine the impact of an Internet-based HIV prevention program on Information-Motivation-Behavior Skills Model-related constructs. Methods Three hundred and sixty-six sexually experienced and inexperienced students 12-18+ years-old in Mbarara, Uganda were randomly assigned to: the five-lesson CyberSenga program or treatment-as-usual. Half of the intervention participants were further randomized to a booster session. Assessments were collected at three and six months post-baseline. Results Participants’ HIV-related information improved over time at a greater rate for the intervention groups compared to the control group. Motivation for condom use changed to a greater degree over time for the intervention group – especially those in the intervention+booster group - compared to the control group. Behavioral skills for condom use, and motivation and behavioral skills for abstinence were statistically similar over time for both groups. Conclusions CyberSenga improves HIV preventive information and motivation to use condoms. PMID:25633626

  4. Effect of management training in organizational justice: a randomized controlled trial

    PubMed Central

    NAKAMURA, Saki; SOMEMURA, Hironori; SASAKI, Norio; YAMAMOTO, Megumi; TANAKA, Mika; TANAKA, Katsutoshi

    2016-01-01

    Organizational justice (OJ) influences the well-being of employees of organizations. We conducted a randomized controlled trial to examine whether or not brief management training increases OJ for subordinates. Study participants were managers and subordinates working in the private manufacturing sector. Randomization at the departmental level generated an intervention group of 23 departments (93 managers and 248 subordinates) and a control group of 23 departments (91 managers and 314 subordinates). Managers in the intervention group received a 90-min training session to investigate the attitudes and behavior of managers and help increase OJ. Subordinates completed self-administered OJ questionnaire surveys on procedural, interpersonal, and informational justice before and 3 months after intervention. For all subordinates, the interaction between group and time in OJ scores obtained before and 3 months after intervention were not significant. However, in subgroup analyses of the lowest tertile group in relation to the baseline of each of the three OJ subscales and total scores, the lowest tertile group of the interpersonal justice subscale showed significant improvement. The results of this study suggest that brief management training in OJ for managers significantly improves a low rating from subordinates in interpersonal justice. Further studies are required to develop a specific intervention method to increase OJ. PMID:26860786

  5. Effect of management training in organizational justice: a randomized controlled trial.

    PubMed

    Nakamura, Saki; Somemura, Hironori; Sasaki, Norio; Yamamoto, Megumi; Tanaka, Mika; Tanaka, Katsutoshi

    2016-06-10

    Organizational justice (OJ) influences the well-being of employees of organizations. We conducted a randomized controlled trial to examine whether or not brief management training increases OJ for subordinates. Study participants were managers and subordinates working in the private manufacturing sector. Randomization at the departmental level generated an intervention group of 23 departments (93 managers and 248 subordinates) and a control group of 23 departments (91 managers and 314 subordinates). Managers in the intervention group received a 90-min training session to investigate the attitudes and behavior of managers and help increase OJ. Subordinates completed self-administered OJ questionnaire surveys on procedural, interpersonal, and informational justice before and 3 months after intervention. For all subordinates, the interaction between group and time in OJ scores obtained before and 3 months after intervention were not significant. However, in subgroup analyses of the lowest tertile group in relation to the baseline of each of the three OJ subscales and total scores, the lowest tertile group of the interpersonal justice subscale showed significant improvement. The results of this study suggest that brief management training in OJ for managers significantly improves a low rating from subordinates in interpersonal justice. Further studies are required to develop a specific intervention method to increase OJ. PMID:26860786

  6. Systemic oxygen therapy versus oral enalapril for treatment of diabetic macular ischemia: a randomized controlled trial.

    PubMed

    Sharifipour, Farideh; Razzaghi, Mohammadreza; Ramezani, Alireza; Azarmina, Mohsen; Yaseri, Mehdi; Soheilian, Roham; Soheilian, Masoud

    2016-04-01

    The purpose of this study was to evaluate the structural and functional effects of systemic oxygen therapy and enalapril in patients with diabetic macular ischemia (DMI). This randomized clinical trial consisted of 105 eyes with DMI divided into three groups. Group I received systemic oxygen by face mask at a flow rate of 10 L/min; Group II received 5 mg enalapril daily; and Group III received placebo tablets for 3 months. Best-corrected visual acuity (BCVA), central macular thickness (CMT) measured by optical coherence tomography (OCT), extent of foveal avascular zone (FAZ) on fluorescein angiograms, and electroretinograms (ERG) were obtained at baseline and after 3 and 6 months. Overall, 102 patients completed the study. Baseline characteristics were not significantly different among groups. Significant improvement in BCVA and decrease in CMT and FAZ occurred at months 3 and 6 in oxygen group compared to deterioration in enalapril and control groups (All P values <0.001). ERG parameters were significantly better in oxygen group compared to enalapril group at months 3 and 6 and better than those in control group at month 3. Normobaric oxygen therapy for 3 months in DMI decreased CMT and FAZ and improved BCVA and ERG parameters. Enalapril did not show any favorable effect. PMID:26292645

  7. Teaching of evidence-based medicine to medical students in Mexico: a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Evidence-Based Medicine (EBM) is an important competency for the healthcare professional. Experimental evidence of EBM educational interventions from rigorous research studies is limited. The main objective of this study was to assess EBM learning (knowledge, attitudes and self-reported skills) in undergraduate medical students with a randomized controlled trial. Methods The educational intervention was a one-semester EBM course in the 5th year of a public medical school in Mexico. The study design was an experimental parallel group randomized controlled trial for the main outcome measures in the 5th year class (M5 EBM vs. M5 non-EBM groups), and quasi-experimental with static-groups comparisons for the 4th year (M4, not yet exposed) and 6th year (M6, exposed 6 months to a year earlier) groups. EBM attitudes, knowledge and self-reported skills were measured using Taylor’s questionnaire and a summative exam which comprised of a 100-item multiple-choice question (MCQ) test. Results 289 Medical students were assessed: M5 EBM=48, M5 non-EBM=47, M4=87, and M6=107. There was a higher reported use of the Cochrane Library and secondary journals in the intervention group (M5 vs. M5 non-EBM). Critical appraisal skills and attitude scores were higher in the intervention group (M5) and in the group of students exposed to EBM instruction during the previous year (M6). The knowledge level was higher after the intervention in the M5 EBM group compared to the M5 non-EBM group (p<0.001, Cohen's d=0.88 with Taylor's instrument and 3.54 with the 100-item MCQ test). M6 Students that received the intervention in the previous year had a knowledge score higher than the M4 and M5 non-EBM groups, but lower than the M5 EBM group. Conclusions Formal medical student training in EBM produced higher scores in attitudes, knowledge and self-reported critical appraisal skills compared with a randomized control group. Data from the concurrent groups add validity evidence to the study

  8. Anopheles punctulatus group: evolution, distribution, and control.

    PubMed

    Beebe, Nigel W; Russell, Tanya; Burkot, Thomas R; Cooper, Robert D

    2015-01-01

    The major malaria vectors of the Southwest Pacific belong to a group of closely related mosquitoes known as the Anopheles punctulatus group. The group comprises 13 co-occurring species that either are isomorphic or carry overlapping morphological features, and today several species remain informally named. The advent of species-diagnostic molecular tools in the 1990s permitted a new raft of studies into the newly differentiated mosquitoes of this group, and these have revealed five species as the region's primary malaria vectors: An. farauti, An. hinesorum, An. farauti 4, An. koliensis, and An. punctulatus. Species' distributions are now well established across Papua New Guinea, northern Australia, and the Solomon Archipelago, but little has been documented thus far in eastern Indonesia. As each species reveals significant differences in distribution and biology, the relative paucity of knowledge of their biology or ecology in relation to malaria transmission is brought into clearer focus. Only three of the species have undergone some form of spatial or population genetics analyses, and this has revealed striking differences in their genetic signatures throughout the region. This review compiles and dissects the key findings for this important mosquito group and points to where future research should focus to maximize the output of field studies in developing relevant knowledge on these malaria vectors. PMID:25341094

  9. Promoting Self-Regulation and Cooperation in Pre-Kindergarten Children with Conduct Problems: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Somech, Lior Y.; Elizur, Yoel

    2012-01-01

    Objective: To evaluate the effectiveness and mechanisms of "Hitkashrut", a "common elements" co-parent training (PT) program for early intervention with preschoolers (3-5 years of age) at risk for conduct problems (CP). Method: A randomized controlled trial with 140 participants in PT and 69 in a minimal intervention control group. The primary…

  10. Aloe Vera Gel and Cesarean Wound Healing; A Randomized Controlled Clinical Trial

    PubMed Central

    Molazem, Zahra; Mohseni, Fatemeh; Younesi, Masoumeh; Keshavarzi, Sareh

    2015-01-01

    Background: Failure in complete healing of the wound is one of the probable complications of cesarean. The present study aimed to determine the effectiveness of dressing with aloe vera gel in healing of cesarean wound. Methods: This prospective randomized double-blind clinical trial was conducted on 90 women who had undergone cesarean operation in Amir-al-Momenin hospital (Gerash, Iran). The participants were randomly divided into two groups each containing 45 patients. In one group, the wound was dressed with aloe vera gel, while simple dressing was used in the control group. Wound healing was assessed 24 hours and 8 days after the cesarean operation using REEDA scale. The data were analyzed through Chi-square and t-test. Results: The participants’ mean age was 27.56±4.20 in the aloe vera group and 26.62±4.88 in the control group, but the difference was not statistically significant. However, a significant difference was found between the two groups concerning body mass index, heart rate, and systolic blood pressure (P<0.05). Also, a significant difference was observed between the two groups with respect to the wound healing score 24 hours after the operation (P=0.003). After 8 days, however, the difference in the wound healing score was not significant (P=0.283). Overall, 45 participants in the aloe vera group and 35 ones in the control group had obtained a zero score 24 hours after the operation. These measures were respectively obtained as 42 and 41eight days after the operation. Conclusion: According to the findings of this study, the women are recommended to be informed regarding the positive effects of dressing with aloe vera gel. PMID:25560349

  11. Topical Tacrolimus versus Hydrocortisone on Atopic Dermatitis in Paediatric Patients: A Randomized Controlled Trial.

    PubMed

    Rahman, M F; Nandi, A K; Kabir, S; Kamal, M; Basher, M S; Banu, L A

    2015-07-01

    Atopic dermatitis (AD) is a chronic, inflammatory skin disease in early childhood. Atopic dermatitis is familial disease, often coexists with other atopic diseases with multiple risk factors associated with atopic eczema. The disease is more frequent in urban areas compared with rural areas. Changes in nutrition and a decrease in infant breast-feeding and respiratory allergies are contributory factors for the condition. A Randomized Controlled Trial (RCT) was carried to compare the efficacy and safety of Tacrolimus ointment with a topical corticosteroid reference therapy. A total 60 patients aged between 2 to 10 years, having atopic dermatitis for at least one year and comply Hanifin-Rajka criteria were selected using random number table and allocated into study and control groups through randomization. Study group was treated with topical Tacrolimus 0.03% twice daily for three weeks, while the control group was treated with 1% Hydrocortisone acetate for the same period. Both groups had a washed out phase for 2 weeks with a follow up period of 6 weeks. Eczema Area and Severity lndex (EASI) was assessed at baseline and three weeks after treatment. Efficacy was evaluated at each visit by six clinical signs of atopic dermatitis through measurement of the affected surface area and the EASI score in each of four body regions. Before intervention, in study group mean EASI score was 11.29 with a SD of 2.14, while in control group it was 11.05 with a SD of 2.46. Difference was statistically insignificant (p>0.05). At the end of the treatment, in study group mean EASI score was 4.86 with a SD of 1.01, while in control group it was 7.97 with a SD of 1.80. Statistically high significant difference was observed between EASI scores of two groups before and after the treatment (p<0.001). After getting treatment with Tacrolimus, median reduction of EASI score was 56.07 in study group, while getting treatment with Hydrocortisone, median reduction of EASI score was 27

  12. Supported Telemonitoring and Glycemic Control in People with Type 2 Diabetes: The Telescot Diabetes Pragmatic Multicenter Randomized Controlled Trial

    PubMed Central

    Wild, Sarah H.; Hanley, Janet; Lewis, Stephanie C.; McKnight, John A.; Padfield, Paul L.; Parker, Richard A.; Pinnock, Hilary; Sheikh, Aziz; McKinstry, Brian

    2016-01-01

    Background Self-monitoring of blood glucose among people with type 2 diabetes not treated with insulin does not appear to be effective in improving glycemic control. We investigated whether health professional review of telemetrically transmitted self-monitored glucose results in improved glycemic control in people with poorly controlled type 2 diabetes. Methods and Findings We performed a randomized, parallel, investigator-blind controlled trial with centralized randomization in family practices in four regions of the United Kingdom among 321 people with type 2 diabetes and glycated hemoglobin (HbA1c) >58 mmol/mol. The supported telemonitoring intervention involved self-measurement and transmission to a secure website of twice-weekly morning and evening glucose for review by family practice clinicians who were not blinded to allocation group. The control group received usual care, with at least annual review and more frequent reviews for people with poor glycemic or blood pressure control. HbA1c assessed at 9 mo was the primary outcome. Intention-to-treat analyses were performed. 160 people were randomized to the intervention group and 161 to the usual care group between June 6, 2011, and July 19, 2013. HbA1c data at follow-up were available for 146 people in the intervention group and 139 people in the control group. The mean (SD) HbA1c at follow-up was 63.0 (15.5) mmol/mol in the intervention group and 67.8 (14.7) mmol/mol in the usual care group. For primary analysis, adjusted mean HbA1c was 5.60 mmol/mol / 0.51% lower (95% CI 2.38 to 8.81 mmol/mol/ 95% CI 0.22% to 0.81%, p = 0·0007). For secondary analyses, adjusted mean ambulatory systolic blood pressure was 3.06 mmHg lower (95% CI 0.56–5.56 mmHg, p = 0.017) and mean ambulatory diastolic blood pressure was 2.17 mmHg lower (95% CI 0.62–3.72, p = 0.006) among people in the intervention group when compared with usual care after adjustment for baseline differences and minimization strata. No significant

  13. Cooperation, control, and concession in meerkat groups.

    PubMed

    Clutton-Brock, T H; Brotherton, P N; Russell, A F; O'Riain, M J; Gaynor, D; Kansky, R; Griffin, A; Manser, M; Sharpe, L; McIlrath, G M; Small, T; Moss, A; Monfort, S

    2001-01-19

    "Limited control" models of reproductive skew in cooperative societies suggest that the frequency of breeding by subordinates is determined by the outcome of power struggles with dominants. In contrast, "optimal skew" models suggest that dominants have full control of subordinate reproduction and allow subordinates to breed only when this serves to retain subordinates' assistance with rearing dominants' own litters. The results of our 7-year field study of cooperative meerkats, Suricata suricatta, support the predictions of limited control models and provide no indication that dominant females grant reproductive concessions to subordinates to retain their assistance with future breeding attempts. PMID:11161200

  14. Bedside charting of pain levels in hospitalized patients with cancer: a randomized controlled trial.

    PubMed

    Kravitz, R L; Delafield, J P; Hays, R D; Drazin, R; Conolly, M

    1996-02-01

    Despite advances in the technology of cancer pain assessment and control, cancer pain often remains undertreated even in hospital settings. To determine whether a graphical display of cancer patients' pain levels might improve their treatment, the investigators conducted a randomized controlled trial. Patients assigned to the intervention group (N = 40) had periodic pain assessments by study staff, who graphically recorded their reported pain-intensity levels on bedside wall charts. Control group patients (N = 38) had periodic pain assessments by study staff but did not have this information displayed. The results failed to show a significant beneficial effect of the intervention on pain control, sleep, cancer-related symptoms, or analgesic dosing, but confidence intervals were broad. More research is needed to improve the quality of care for inpatients with cancer-related pain. PMID:8907138

  15. Two Self-management Interventions to Improve Hypertension Control: A Randomized Trial

    PubMed Central

    Bosworth, Hayden B.; Olsen, Maren K.; Grubber, Janet M.; Neary, Alice M.; Orr, Melinda M.; Powers, Benjamin J.; Adams, Martha B.; Svetkey, Laura P.; Reed, Shelby D.; Li, Yanhong; Dolor, Rowena J.; Oddone, Eugene Z.

    2010-01-01

    Background Less than 40% of Americans with hypertension have adequate blood pressure (BP) control. Objectives To compare two self-management interventions for improving BP control among hypertensive patients. Design A 2 by 2 randomized trial stratified by enrollment site and patient literacy status with two-year follow-up (5/2004-1/2008). Setting Two university-affiliated primary care clinics. Patients 636 patients were randomized (31% recruitment rate) among the 2060 eligible hypertensive patients. Interventions Research assistants randomized eligible patients via a centralized blinded and stratified randomization algorithm to receive either: 1) usual care; 2) bi-monthly tailored nurse-administered telephone intervention targeting hypertension-related behaviors; 3) BP monitoring consisting of measuring BP three times per week, or; 4) a combination of the two interventions. Measurements The primary outcome was BP control evaluated at six-month intervals over 24 months. 475 (75%) completed the 24-month BP follow-up. Results Improvements in proportion of BP control for the intervention groups relative to the usual care group at 24 months were: behavioral group, 4.3% (95% CI: −4.5%, 12.9); home BP monitoring group, 7.6% (95% CI: −1.9%, 17.0%); and, combined interventions, 11.0% (95% CI: 1.9%, 19.8%). For systolic BP, relative to usual care, the 24 month difference was, +0.6 mmHg (95% CI: −2.2, 3.4) for the behavioral intervention group, −0.6 mmHg (95% CI: −3.6, 2.3) for the home monitoring group, and −3.9 mmHg (95% CI: −6.9, −0.9) for the combined interventions. Similar patterns were observed for diastolic BP at 24 months. Limitations Changes in medication use and diet were only monitored in intervention participants; 25% lacked 24 month outcome data; 73% had adequate BP control at baseline; the study setting was an academic health center, all factors that potentially limit generalizability. Conclusion Combined home BP monitoring and tailored

  16. Strength and agility training in adolescents with Down syndrome: a randomized controlled trial.

    PubMed

    Lin, Hsiu-Ching; Wuang, Yee-Pay

    2012-01-01

    The purpose of this study was to investigate the effects of a proposed strength and agility training program of adolescents with Down syndrome. Ninety-two adolescents were recruited and evenly randomized to two intervention groups (exercise group vs. control group). The mean age for the exercise and the control group was 10.6±3.2 and 11.2±3.5 respectively. The exercise training program consisted of a 5-min treadmill exercise and one 20-min virtual-reality based activity administered three times a week for 6 weeks. Pre- and post-test measures were taken for muscle strength and agility performance. The measured muscle included hip extensor, hip flexor, knee extensor, knee flexors, hip abductors, and ankle plantarflexor. A handheld dynamometer was used to measure the lower extremities muscle strength, and agility performance was assessed by the strength and agility subtests of the Bruininks-Oseretsky Test of Motor Proficiency-Second Edition. The exercise group had significant improvements in agility (p=0.02, d=0.80) and muscle strength of all muscle group (all p's<0.05, d=0.51-0.89) assessed in comparison to the control group after the 6-week intervention. Knee muscle groups including both flexors and extensors had the greatest gains among all the muscles measured. A short-term exercise training program used in this study is capable of improving muscle strength and agility performance of adolescents with DS. PMID:22820064

  17. Efficacy and safety of acupuncture for chronic dizziness: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Dizziness is one of the most challenging symptoms in medicine. No medication for dizziness in current use has well-established curative or prophylactic value or is suitable for long-term palliative use. Unconventional remedies, such as acupuncture, should be considered and scientifically evaluated. However, there has been relatively little evidence in randomized controlled clinical trials on acupuncture to treat chronic dizziness. The aim of our study is to evaluate the efficacy and safety of acupuncture in patients with dizziness. Methods/Design This trial is a randomized, single-blind, controlled study. A total of 80 participants will be randomly assigned to two treatment groups receiving acupuncture and sham acupuncture treatment, respectively, for 4 weeks. The primary outcome measures are the Dizziness Handicap Inventory (DHI) and the Vertigo Symptom Scale (VSS). Treatment will be conducted over a period of 4 weeks, at a frequency of two sessions per week. The assessment is at baseline (before treatment initiation), 4 weeks after the first acupuncture session, and 8 weeks after the first acupuncture session. Discussion The results from this study will provide clinical evidence on the efficacy and safety of acupuncture in patients with chronic dizziness. Trial registration International Standard Randomized Controlled Trial Number Register: ISRCTN52695239 PMID:24330810

  18. Creation and implementation of a historical controls database from randomized clinical trials

    PubMed Central

    Desai, Jigar R; Bowen, Edward A; Danielson, Mark M; Allam, Rajasekhar R; Cantor, Michael N

    2013-01-01

    Background Ethical concerns about randomly assigning patients to suboptimal or placebo arms and the paucity of willing participants for randomization into control and experimental groups have renewed focus on the use of historical controls in clinical trials. Although databases of historical controls have been advocated, no published reports have described the technical and informatics issues involved in their creation. Objective To create a historical controls database by leveraging internal clinical trial data at Pfizer, focusing on patients who received only placebo in randomized controlled trials. Methods We transformed disparate clinical data sources by indexing, developing, and integrating clinical data within internal databases and archives. We focused primarily on trials mapped into a consistent standard and trials in the pain therapeutic area as a pilot. Results Of the more than 20 000 internal Pfizer clinical trials, 2404 completed placebo controlled studies with a parallel design were identified. Due to challenges with informed consent and data standards used in older clinical trials, studies completed before 2000 were excluded, yielding 1134 studies from which placebo subjects and associated clinical data were extracted. Conclusions It is technically feasible to pool portions of placebo populations through a stratification and segmentation approach for a historical placebo group database. A sufficiently large placebo controls database would enable previous distribution calculations on representative populations to supplement, not eliminate, the placebo arm of future clinical trials. Creation of an industry-wide placebo controls database, utilizing a universal standard, beyond the borders of Pfizer would add significant efficiencies to the clinical trial and drug development process. PMID:23449762

  19. Standards of Reporting of Randomized Controlled Trials in General Surgery

    PubMed Central

    Balasubramanian, Sabapathy P.; Wiener, Martin; Alshameeri, Zeiad; Tiruvoipati, Ravindranath; Elbourne, Diana; Reed, Malcolm W.

    2006-01-01

    Objective: To evaluate the quality of reporting of surgical randomized controlled trials published in surgical and general medical journals using Jadad score, allocation concealment, and adherence to CONSORT guidelines and to identify factors associated with good quality. Summary Background Data: Randomized controlled trials (RCTs) provide the best evidence about the relative effectiveness of different interventions. Improper methodology and reporting of RCTs can lead to erroneous conclusions about treatment effects, which may mislead decision-making in health care at all levels. Methods: Information was obtained on RCTs published in 6 general surgical and 4 general medical journals in the year 2003. The quality of reporting of RCTs was assessed under masked conditions using allocation concealment, Jadad score, and a CONSORT checklist devised for the purpose. Results: Of the 69 RCTs analyzed, only 37.7% had a Jadad score of ≥3, and only 13% of the trials clearly explained allocation concealment. The modified CONSORT score of surgical trials reported in medical journals was significantly higher than those reported in surgical journals (Mann-Whitney U test, P < 0.001). Overall, the modified CONSORT score was higher in studies with higher author numbers (P = 0.03), multicenter studies (P = 0.002), and studies with a declared funding source (P = 0.022). Conclusion: The overall quality of reporting of surgical RCTs was suboptimal. There is a need for improving awareness of the CONSORT statement among authors, reviewers, and editors of surgical journals and better quality control measures for trial reporting and methodology. PMID:17060756

  20. Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects: The PROMOTE Study A Randomized Controlled Trial

    PubMed Central

    HENSEL, Kendi L.; BUCHANAN, Steve; BROWN, Sarah K.; RODRIGUEZ, Mayra; CRUSER, des Anges

    2014-01-01

    Objective To evaluate the efficacy of Osteopathic Manipulative Treatment (OMT) to reduce low back pain and improve functioning during the third trimester in pregnancy and improve selected outcomes of labor and delivery. Study Design PROMOTE was a randomized, placebo-controlled trial of 400 women in their third trimester. Women were randomized to usual care only (UCO), usual care plus OMT (OMT), or usual care plus placebo ultrasound treatment (PUT). The study included seven treatments over nine weeks. The OMT protocol included specific techniques administered by board-certified OMT specialists. Outcomes were assessed using self-report measures for pain and back-related functioning, and medical records for delivery outcomes. Results There were 136 women in the OMT group, 131 in PUT, and 133 in UCO. Characteristics at baseline were similar across groups. Findings indicate significant treatment effects for pain and back related functioning (P<.001 for both), with outcomes for the OMT group similar to that of the PUT, but both groups were significantly improved compared to UCO. For secondary outcome of meconium- stained amniotic fluid there were no differences between the groups. Conclusion OMT was effective for mitigating pain and functional deterioration compared to the UCO group; however OMT did not differ significantly from PUT. This may be attributed to PUT being a more active treatment than intended. There was no higher likelihood of conversion to high risk status based on treatment group. Therefore, OMT is a safe, effective adjunctive modality to improve pain and functioning during their third trimester. PMID:25068560

  1. Paraspinous Lidocaine Injection for Chronic Nonspecific Low Back Pain: A Randomized Controlled Clinical Trial

    PubMed Central

    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

    2016-01-01

    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. PMID:26828801

  2. Brief Report: Staged-informed Consent in the Cohort Multiple Randomized Controlled Trial Design.

    PubMed

    Young-Afat, Danny A; Verkooijen, Helena A M; van Gils, Carla H; van der Velden, Joanne M; Burbach, Johannes P; Elias, Sjoerd G; van Delden, Jonannes J; Relton, Clare; van Vulpen, Marco; van der Graaf, Rieke

    2016-05-01

    The "cohort multiple randomized controlled trial," a new design for pragmatic trials, embeds multiple trials within a cohort. The cohort multiple RCT is an attractive alternative to conventional RCTs in fields where recruitment is slow, multiple new (competing) interventions for the same condition have to be tested, new interventions are highly preferred by patients and doctors, and the risk of disappointment bias, cross-over, and contamination is considerable. To prevent these unwanted effects, the cohort multiple RCT provides information on randomization to the intervention group/arm only, and only after randomization (i.e., prerandomization). To some, especially in a clinical setting, this is not ethically acceptable. In this article, we argue that prerandomization in the cohort multiple randomized controlled trial (cmRCT) can be avoided by adopting a staged-informed consent procedure. In the first stage, at entry into the cohort, all potential participants are asked for their informed consent to participate in a cohort study and broad consent to be either randomly selected to be approached for experimental interventions or to serve as control without further notice during participation in the cohort. In a second stage, at the initiation of an RCT within the cohort, informed consent to receive the intervention is then only sought in those randomly selected for the intervention arm. At the third stage, after completion of each RCT, all cohort participants receive aggregate disclosure of trial results. This staged-informed consent procedure avoids prerandomization in cmRCT and aims to keep participants actively engaged in the research process. PMID:27035689

  3. Preconception maternal nutrition: a multi-site randomized controlled trial

    PubMed Central

    2014-01-01

    Background Research directed to optimizing maternal nutrition commencing prior to conception remains very limited, despite suggestive evidence of its importance in addition to ensuring an optimal nutrition environment in the periconceptional period and throughout the first trimester of pregnancy. Methods/Study design This is an individually randomized controlled trial of the impact on birth length (primary outcome) of the time at which a maternal nutrition intervention is commenced: Arm 1: ≥ 3 mo preconception vs. Arm 2: 12-14 wk gestation vs. Arm 3: none. 192 (derived from 480) randomized mothers and living offspring in each arm in each of four research sites (Guatemala, India, Pakistan, Democratic Republic of the Congo). The intervention is a daily 20 g lipid-based (118 kcal) multi-micronutient (MMN) supplement. Women randomized to receive this intervention with body mass index (BMI) <20 or whose gestational weight gain is low will receive an additional 300 kcal/d as a balanced energy-protein supplement. Researchers will visit homes biweekly to deliver intervention and monitor compliance, pregnancy status and morbidity; ensure prenatal and delivery care; and promote breast feeding. The primary outcome is birth length. Secondary outcomes include: fetal length at 12 and 34 wk; incidence of low birth weight (LBW); neonatal/infant anthropometry 0-6 mo of age; infectious disease morbidity; maternal, fetal, newborn, and infant epigenetics; maternal and infant nutritional status; maternal and infant microbiome; gut inflammatory biomarkers and bioactive and nutritive compounds in breast milk. The primary analysis will compare birth Length-for-Age Z-score (LAZ) among trial arms (independently for each site, estimated effect size: 0.35). Additional statistical analyses will examine the secondary outcomes and a pooled analysis of data from all sites. Discussion Positive results of this trial will support a paradigm shift in attention to nutrition of all females of

  4. Aggressive parenteral nutrition in sick very low birth weight babies: a randomized controlled trial.

    PubMed

    Tagare, Amit; Walawalkar, Meenal; Vaidya, Umesh

    2013-10-01

    Survival of preterm neonates in developing world has improved. Developing countries lag behind in nutritional management in NICU especially parenteral nutrition (PN). This randomized controlled trial was done to evaluate the effect of aggressive parenteral nutrition on nitrogen retention of sick VLBW and extremely low birth weight (ELBW) babies. From September 2009 to February 2010, total 34 babies were randomized to receive aggressive parenteral nutrition (APN)(n=17) or standard parenteral nutrition (SPN) (n=17). The average daily total and PN calory intake of babies in APN group was significantly higher during first week. APN was well-tolerated; however, nitrogen retention was not significantly higher in APN group. Aggressive parenteral nutrition in sick VLBW babies is feasible in developing world, though it did not improve nitrogen retention in first week of life. PMID:23798635

  5. Weight loss improves reproductive outcomes in obese women undergoing fertility treatment: a randomized controlled trial.

    PubMed

    Sim, K A; Dezarnaulds, G M; Denyer, G S; Skilton, M R; Caterson, I D

    2014-04-01

    For women attempting pregnancy, obesity reduces fertility and is an independent risk factor for obstetric and neonatal complications. The aim of this evaluator-blinded, randomized controlled trial was to evaluate a weight loss intervention on pregnancy rates in obese women undertaking fertility treatment. Forty-nine obese women, aged ≤ 37 years, presenting for fertility treatment were randomized to either a 12-week intervention (n = 27) consisting of a very-low-energy diet for the initial 6 weeks followed by a hypocaloric diet, combined with a weekly group multidisciplinary programme; or a control group (n = 22) who received recommendations for weight loss and the same printed material as the intervention. Anthropometric and reproductive parameters were measured at baseline and at 12 weeks. The 22 women who completed the intervention had greater anthropometric changes (-6.6 ± 4.6 kg and -8.7 ± 5.6 cm vs. -1.6 ± 3.6 kg and -0.6 ± 6.3 cm) compared with the control group (n = 17; P < 0.001). The intervention group achieved a pregnancy rate of 48% compared with 14% (P = 0.007), took a mean two fertility treatment cycles to achieve each pregnancy compared with four in the control group (P = 0.002), and had a marked increase in the number of live births (44% vs. 14%; P = 0.02). A group weight loss programme, incorporating dietary, exercise and behavioural components, is associated with a significant improvement in pregnancy rates and live births in a group of obese women undergoing fertility treatment. PMID:25826729

  6. Effect of Using Eye Mask on Sleep Quality in Cardiac Patients: A Randomized Controlled Trial

    PubMed Central

    Babaii, Atye; Adib-Hajbaghery, Mohsen; Hajibagheri, Ali

    2015-01-01

    Background: Patients in coronary care unit are at risk of sleep deprivation. Sleep deprivation can be associated with increased blood pressure and heart rate, raising the risk of developing cardiovascular problems among patients hospitalized in coronary care unit. Objectives: This study was carried out to examine the effect of eye mask on sleep quality in cardiac patients. Patients and Methods: In this randomized controlled trial, 60 patients who met the inclusion criteria were selected using a convenient sampling method and randomly allocated into the experimental and control groups. Patients in the control group received routine care. However, in the experimental group, patients received routine care and eye mask for three subsequent nights. In the both groups, the sleep quality was assessed using the Pittsburgh sleep quality index. Data were analyzed by the chi-square test, independent samples t-test, Mann-Whitney U, and Wilcoxon signed-rank tests. Results: After the study, the median scores of the subjective sleep quality, the sleep latency, the sleep duration, the habitual sleep efficiency, and the sleep disturbances domains, as well as the median score of overall Pittsburgh sleep quality index in the experimental group were significantly lower than those in the control group (P < 0.05). However, no significant differences were observed between the two groups in terms of the use of sleep medications and the daytime dysfunction domains (P > 0.05). Conclusions: Using eye mask can significantly improve the sleep quality in cardiac patients. Therefore, nurses are recommended to use eye mask in combination with current treatments for improving patients’ sleep quality. PMID:26835463

  7. Hydrotherapy for the Treatment of Pain in People with Multiple Sclerosis: A Randomized Controlled Trial

    PubMed Central

    Castro-Sánchez, Adelaida María; Matarán-Peñarrocha, Guillermo A.; Lara-Palomo, Inmaculada; Saavedra-Hernández, Manuel; Arroyo-Morales, Manuel; Moreno-Lorenzo, Carmen

    2012-01-01

    Background. Multiple sclerosis (MS) is a chronic demyelinating neurological disease. Several studies have reported that complementary and alternative therapies can have positive effects against pain in these patients. Objective. The objective was to investigate the effectiveness of an Ai-Chi aquatic exercise program against pain and other symptoms in MS patients. Methods. In this randomized controlled trial, 73 MS patients were randomly assigned to an experimental or control group for a 20-week treatment program. The experimental group underwent 40 sessions of Ai-Chi exercise in swimming pool and the control group 40 sessions of abdominal breathing and contraction-relaxation exercises in therapy room. Outcome variables were pain, disability, spasm, depression, fatigue, and autonomy, which were assessed before the intervention and immediately and at 4 and 10 weeks after the last treatment session. Results. The experimental group showed a significant (P < 0.028) and clinically relevant decrease in pain intensity versus baseline, with an immediate posttreatment reduction in median visual analogue scale scores of 50% that was maintained for up to 10 weeks. Significant improvements were also observed in spasm, fatigue, disability, and autonomy. Conclusion. According to these findings, an Ai-Chi aquatic exercise program improves pain, spasms, disability, fatigue, depression, and autonomy in MS patients. PMID:21785645

  8. Effects of mailed advice on stress reduction among employees in Japan: a randomized controlled trial.

    PubMed

    Kawakami, N; Haratani, T; Iwata, N; Imanaka, Y; Murata, K; Araki, S

    1999-04-01

    We conducted a randomized controlled trial (RCT) to examine the effects of mailed advice on reducing psychological distress, blood pressure, serum lipids, and sick leave of workers employed in a manufacturing plant in Japan. Those who indicated higher psychological distress (defined as having GHQ scores of three or greater) in the baseline questionnaire survey (n = 226) were randomly assigned to an intervention group or a control group. Individualized letters were sent to the subjects of the intervention group, informing them of their stress levels and recommending an improvement in daily habits and other behaviors to reduce stress. Eighty-one and 77 subjects in the intervention and control groups, respectively, responded to the one-year follow-up survey. No significant intervention effect was observed for the GHQ scores, blood pressure, serum lipids, or sick leave (p > 0.05). The intervention effect was marginally significant for changes in regular breakfasts and daily alcohol consumption (p = 0.09). The intervention effect was marginally significant for the GHQ scores among those who initially did not eat breakfast regularly (p = 0.06). The study suggests that only sending mailed advice is not an effective measure for worksite stress reduction. Mailed advice which focuses on a particular subgroup (e.g., those who do not eat breakfast regularly) may be more effective. PMID:10319572

  9. Effects of dehydroepiandrosterone supplementation during stressful military training: a randomized, controlled, double-blind field study.

    PubMed

    Taylor, Marcus K; Padilla, Genieleah A; Stanfill, Katherine E; Markham, Amanda E; Khosravi, Jasmine Y; Ward, Michael D Dial; Koehler, Matthew M

    2012-01-01

    Dehydroepiandrosterone (DHEA) and DHEA sulfate (DHEAS) are anabolic prehormones involved in the synthesis of testosterone. Both have been shown to exert neuroprotective effects during stress. In this randomized, controlled, double-blind field study, we examined the effects of a 12-day DHEA regimen on stress indices in military men undergoing survival training. Forty-eight men were randomized to either a DHEA treatment group or placebo control group. The treatment group received 50 mg of oral DHEA supplementation daily for 5 days during classroom training followed by 7 days of 75 mg during stressful field operations. Control subjects received identical placebo pills. Salivary assays (DHEA[S], testosterone, and cortisol) were conducted at four time points: distal pre-stress (T1), proximal pre-stress (T2), mock-captivity stress (T3), and 24 h recovery (T4). Subjective distress was also assessed at T1, T3, and T4. As expected, DHEA treatment resulted in higher salivary concentrations of DHEA and DHEAS during daily living, mock-captivity stress, and recovery. Similar patterns were observed for salivary markers of anabolic balance: DHEA/cortisol, DHEAS/cortisol, and testosterone/cortisol concentration ratios. Despite notable time effects, no group differences emerged for subjective distress. A brief, low dose DHEA regimen yielded large increases in salivary DHEA(S) concentrations and enhanced anabolic balance throughout sustained military stress. These physiological changes did not extrapolate to subjective distress. PMID:21790446

  10. Pulsatile dry cupping in patients with osteoarthritis of the knee – a randomized controlled exploratory trial

    PubMed Central

    2012-01-01

    Introduction Cupping is used in various traditional medicine forms to relieve pain in musculoskeletal diseases. The aim of this study was to investigate the effectiveness of cupping in relieving the symptoms of knee osteoarthritis (OA). Methods In a two-group, randomized controlled exploratory pilot study patients with a clinically and radiological confirmed knee OA (Kellgren-Lawrence Grading Scale: 2-4) and a pain intensity > 40 mm on a 100 mm visual analogue scale (VAS) were included. 40 Patients were randomized to either 8 sessions of pulsatile dry cupping within 4 weeks or no intervention (control). Paracetamol was allowed on demand for both groups. Outcomes were the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) score, the pain intensity on a VAS (0 mm = no pain to 100 mm = maximum intensity) and Quality of Life (SF-36) 4 and 12 weeks after randomization. Use of Paracetamol was documented within the 4-week treatment period. Analyses were performed by analysis of covariance adjusting for the baseline value for each outcome. Results 21 patients were allocated to the cupping group (5 male; mean age 68 ± SD 7.2) and 19 to the control group (8 male; 69 ± 6.8). After 4 weeks the WOMAC global score improved significantly more in the cupping group with a mean of 27.7 (95% confidence interval 22.1; 33.3) compared to 42.2 (36.3; 48.1) in the control group (p = 0.001). After 12 weeks the WOMAC global score were still significantly different in favor for cupping (31.0 (24.9; 37.2) vs. 40.8 (34.4; 47.3) p = 0.032), however the WOMAC subscores for pain and stiffness were not significant anymore. Significantly better outcomes in the cupping group were also observed for pain intensity on VAS and for the SF-36 Physical Component Scale compared to the control group after 4 and 12 weeks. No significant difference was observed for the SF-36 Mental Component Scale and the total number of consumed Paracetamol tablets

  11. The anxiolytic effect of aromatherapy on patients awaiting ambulatory surgery: a randomized controlled trial.

    PubMed

    Ni, Cheng-Hua; Hou, Wen-Hsuan; Kao, Ching-Chiu; Chang, Ming-Li; Yu, Lee-Fen; Wu, Chia-Che; Chen, Chiehfeng

    2013-01-01

    The aim of this study was to determine if aromatherapy could reduce preoperative anxiety in ambulatory surgery patients. A total of 109 preoperative patients were randomly assigned to experimental (bergamot essential oil) and control (water vapor) conditions and their responses to the State Trait Anxiety Inventory and vital signs were monitored. Patients were stratified by previous surgical experience, but that did not influence the results. All those exposed to bergamot essential oil aromatherapy showed a greater reduction in preoperative anxiety than those in the control groups. Aromatherapy may be a useful part of a holistic approach to reducing preoperative anxiety before ambulatory surgery. PMID:24454517

  12. A Prospective Randomized Controlled Trial of an Interpersonal Violence Prevention Program With a Mexican American Community

    PubMed Central

    Kelly, Patricia J.; Lesser, Janna; Cheng, An-Lin; Osóos-Sánchez, Manuel; Martinez, Elisabeth; Pineda, Daniel; Mancha, Juan

    2014-01-01

    Using methods of community-based participatory research, a prospective randomized controlled trial of a violence prevention program based on Latino cultural values was implemented with elementary school children in a Mexican American community. Community members participated in intervention program selection, implementation, and data collection. High-risk students who participated in the program had greater nonviolent self-efficacy and demonstrated greater endorsement of program values than did high-risk students in the control group. This collaborative partnership was able to combine community-based participatory research with a rigorous study design and provide sustained benefit to community partners. PMID:20531101

  13. The Effect of Intradialytic Aerobic Exercise on Dialysis Efficacy in Hemodialysis Patients: A Randomized Controlled Trial

    PubMed Central

    Mohseni, Raheleh; Emami Zeydi, Amir; Ilali, Ehteramosadat; Adib-Hajbaghery, Mohsen; Makhlough, Atieh

    2013-01-01

    Objective This study was conducted to determine the impact of an 8-week intradialytic exercise program (consisting of 15 minutes low-intensity exercise during the first 2 hours of dialysis) on dialysis efficacy. Methods In an open randomized controlled trial, a total of 50 clinically stable hemodialysis patients were enrolled into the study and randomly allocated into two groups: the aerobic exercise group (n=25) and the control group (n=25). Aerobic exercises were done in the intervention group for 15 min/day, three times a week for 2 months. The dialysis efficacy was assessed prior to and at the end of each month of the program. Results The efficacy of dialysis increased at the end of the first month and remained elevated for the duration of the program in the exercise group (p<0.05). Conclusion A simplified aerobic exercise program has increased the efficacy of dialysis and may be considered as a safe, complementary and effective modality for hemodialysis patients. PMID:24044062

  14. Immunomodulatory Effects of Kimchi in Chinese Healthy College Students: A Randomized Controlled Trial

    PubMed Central

    Lee, Hansongyi; Kim, Do Yeon; Lee, Mi Ae; Jang, Ja-Young

    2014-01-01

    This study examined the potential immunomodulatory effects of Kimchi, a traditional fermented Korean vegetable, in healthy Chinese college students. The four-week clinical-trial (randomized, open-label, prospective, controlled) was followed by a one week wash-out period. Healthy Chinese college students (over 20 years of age with a body mass index of 18.5-23.0 kg/m2) volunteered for this study. Forty-three students were randomly classified into two groups, Kimchi (n = 21, supplemented with 100 g of Kimchi per day) or non-Kimchi (n = 22, supplemented with 100 g of radish per day, control) groups. During the four-week intervention period, students were asked to maintain their usual diet and activity, and instructed not to take any medications, functional food products, or dietary supplements. Anthropometrics, nutritional intake, and blood immune parameters (lymphocyte subsets, cytokines, and immunoglobulins) were measured before and after the four weeks of intervention. Thirty-nine students (19 in the Kimchi group, 20 in the non-Kimchi group) finished the study. After the intervention, no significant changes were observed in lymphocyte subsets (T-cell, B-cell, NK cell), pro-inflammatory cytokines (IL-6, TNF-α), anti-inflammatory cytokines (IL-4 and IL-10), and immunoglobulins (Ig A, G, and M) between groups in either the Kimchi or non-Kimchi. These results suggest that the short-term consumption of Kimchi has no immunomodulatory effects in healthy Chinese college students. PMID:25136537

  15. Immunomodulatory effects of kimchi in chinese healthy college students: a randomized controlled trial.

    PubMed

    Lee, Hansongyi; Kim, Do Yeon; Lee, Mi Ae; Jang, Ja-Young; Choue, Ryowon

    2014-07-01

    This study examined the potential immunomodulatory effects of Kimchi, a traditional fermented Korean vegetable, in healthy Chinese college students. The four-week clinical-trial (randomized, open-label, prospective, controlled) was followed by a one week wash-out period. Healthy Chinese college students (over 20 years of age with a body mass index of 18.5-23.0 kg/m(2)) volunteered for this study. Forty-three students were randomly classified into two groups, Kimchi (n = 21, supplemented with 100 g of Kimchi per day) or non-Kimchi (n = 22, supplemented with 100 g of radish per day, control) groups. During the four-week intervention period, students were asked to maintain their usual diet and activity, and instructed not to take any medications, functional food products, or dietary supplements. Anthropometrics, nutritional intake, and blood immune parameters (lymphocyte subsets, cytokines, and immunoglobulins) were measured before and after the four weeks of intervention. Thirty-nine students (19 in the Kimchi group, 20 in the non-Kimchi group) finished the study. After the intervention, no significant changes were observed in lymphocyte subsets (T-cell, B-cell, NK cell), pro-inflammatory cytokines (IL-6, TNF-α), anti-inflammatory cytokines (IL-4 and IL-10), and immunoglobulins (Ig A, G, and M) between groups in either the Kimchi or non-Kimchi. These results suggest that the short-term consumption of Kimchi has no immunomodulatory effects in healthy Chinese college students. PMID:25136537

  16. Homeopathic arnica for prevention of pain and bruising: randomized placebo-controlled trial in hand surgery.

    PubMed

    Stevinson, C; Devaraj, V S; Fountain-Barber, A; Hawkins, S; Ernst, E

    2003-02-01

    Homeopathic arnica is widely believed to control bruising, reduce swelling and promote recovery after local trauma; many patients therefore take it perioperatively. To determine whether this treatment has any effect, we conducted a double-blind, placebo-controlled, randomized trial with three parallel arms. 64 adults undergoing elective surgery for carpal tunnel syndrome were randomized to take three tablets daily of homeopathic arnica 30C or 6C or placebo for seven days before surgery and fourteen days after surgery. Primary outcome measures were pain (short form McGill Pain Questionnaire) and bruising (colour separation analysis) at four days after surgery. Secondary outcome measures were swelling (wrist circumference) and use of analgesic medication (patient diary). 62 patients could be included in the intention-to-treat analysis. There were no group differences on the primary outcome measures of pain (P=0.79) and bruising (P=0.45) at day four. Swelling and use of analgesic medication also did not differ between arnica and placebo groups. Adverse events were reported by 2 patients in the arnica 6C group, 3 in the placebo group and 4 in the arnica 30C group. The results of this trial do not suggest that homeopathic arnica has an advantage over placebo in reducing postoperative pain, bruising and swelling in patients undergoing elective hand surgery. PMID:12562974

  17. Homeopathic arnica for prevention of pain and bruising: randomized placebo-controlled trial in hand surgery

    PubMed Central

    Stevinson, C; Devaraj, V S; Fountain-Barber, A; Hawkins, S; Ernst, E

    2003-01-01

    Homeopathic arnica is widely believed to control bruising, reduce swelling and promote recovery after local trauma; many patients therefore take it perioperatively. To determine whether this treatment has any effect, we conducted a double-blind, placebo-controlled, randomized trial with three parallel arms. 64 adults undergoing elective surgery for carpal tunnel syndrome were randomized to take three tablets daily of homeopathic arnica 30C or 6C or placebo for seven days before surgery and fourteen days after surgery. Primary outcome measures were pain (short form McGill Pain Questionnaire) and bruising (colour separation analysis) at four days after surgery. Secondary outcome measures were swelling (wrist circumference) and use of analgesic medication (patient diary). 62 patients could be included in the intention-to-treat analysis. There were no group differences on the primary outcome measures of pain (P=0.79) and bruising (P=0.45) at day four. Swelling and use of analgesic medication also did not differ between arnica and placebo groups. Adverse events were reported by 2 patients in the arnica 6C group, 3 in the placebo group and 4 in the arnica 30C group. The results of this trial do not suggest that homeopathic arnica has an advantage over placebo in reducing postoperative pain, bruising and swelling in patients undergoing elective hand surgery. PMID:12562974

  18. Interreality for the management and training of psychological stress: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Psychological stress occurs when an individual perceives that environmental demands tax or exceed his or her adaptive capacity. Its association with severe health and emotional diseases, points out the necessity to find new efficient strategies to treat it. Moreover, psychological stress is a very personal problem and requires training focused on the specific needs of individuals. To overcome the above limitations, the INTERSTRESS project suggests the adoption of a new paradigm for e-health - Interreality - that integrates contextualized assessment and treatment within a hybrid environment, bridging the physical and the virtual worlds. According to this premise, the aim of this study is to investigate the advantages of using advanced technologies, in combination with cognitive behavioral therapy (CBT), based on a protocol for reducing psychological stress. Methods/Design The study is designed as a randomized controlled trial. It includes three groups of approximately 50 subjects each who suffer from psychological stress: (1) the experimental group, (2) the control group, (3) the waiting list group. Participants included in the experimental group will receive a treatment based on cognitive behavioral techniques combined with virtual reality, biofeedback and mobile phone, while the control group will receive traditional stress management CBT-based training, without the use of new technologies. The wait-list group will be reassessed and compared with the two other groups five weeks after the initial evaluation. After the reassessment, the wait-list patients will randomly receive one of the two other treatments. Psychometric and physiological outcomes will serve as quantitative dependent variables, while subjective reports of participants will be used as the qualitative dependent variable. Discussion What we would like to show with the present trial is that bridging virtual experiences, used to learn coping skills and emotional regulation, with real

  19. A randomized control trial of the effect of yoga on verbal aggressiveness in normal healthy volunteers

    PubMed Central

    Deshpande, Sudheer; Nagendra, H R; Raghuram, Nagarathna

    2008-01-01

    Objective: To study the effect of yoga on verbal aggressiveness in normal healthy adults. Methods: Of the 1228 persons who attended introductory lectures, 226 subjects of both sexes who satisfied the inclusion and exclusion criteria and who consented to participate in the study were randomly allocated into two groups. These 226 subjects were between the ages of 17 and 62 years and 173/226 completed the eight weeks of intervention. The Yoga (Y) group practised an integrated yoga module that included asanas, pranayama, meditation, notional correction, and devotional sessions. The control group practised mild to moderate physical exercises (PE). Both groups had supervised practices (by trained experts) for one hour daily, six days a week for eight weeks. Verbal Aggressiveness was assessed before and after eight weeks using the self-administered Verbal Aggressive Scale. Results: The baseline score of the two groups did not differ significantly (P = 0.66). There was a significant decrease in verbal aggressiveness in the yoga group (P = 0.01 paired samples t-test) with a nonsignificant increase in the PE group. ANCOVA using pre- values as covariates showed a significant difference between the groups (P = 0.013). RMANOVA for interaction between the sexes or age groups in change scores were not significant. Conclusions: This study has demonstrated that an eight week intervention of an integrated yoga module decreased verbal aggressiveness in the yoga group (in males and those below 25 years of age), with a nonsignificant increase in the PE group. PMID:21829289

  20. Telemetry, Tracking, and Control Working Group report

    NASA Technical Reports Server (NTRS)

    Campbell, Richard; Rogers, L. Joseph

    1986-01-01

    After assessing the design implications and the criteria to be used in technology selection, the technical problems that face the telemetry, tracking, and control (TTC) area were defined. For each of the problems identified, recommendations were made for needed technology developments. These recommendations are listed and ranked according to priority.

  1. Group-Randomized Trial of a Proactive, Personalized Telephone Counseling Intervention for Adolescent Smoking Cessation

    PubMed Central

    Kealey, Kathleen A.; Mann, Sue L.; Marek, Patrick M.; Ludman, Evette J.; Liu, Jingmin; Bricker, Jonathan B.

    2009-01-01

    Background The Hutchinson Study of High School Smoking randomized trial was designed to rigorously evaluate a proactive, personalized telephone counseling intervention for adolescent smoking cessation. Methods Fifty randomly selected Washington State high schools were randomized to the experimental or control condition. High school junior smokers were proactively identified (N = 2151). Trained counselors delivered the motivational interviewing plus cognitive behavioral skills training telephone intervention to smokers in experimental schools during their senior year of high school. Participants were followed up, with 88.8% participation, to outcome ascertainment more than 1 year after random assignment. The main outcome was 6-months prolonged abstinence from smoking. All statistical tests were two-sided. Results The intervention increased the percentage who achieved 6-month prolonged smoking abstinence among all smokers (21.8% in the experimental condition vs 17.7% in the control condition, difference = 4.0%, 95% confidence interval [CI] = −0.2 to 8.1, P = .06) and in particular among daily smokers (10.1% vs 5.9%, difference = 4.1%, 95% CI = 0.8 to 7.1, P = .02). There was also generally strong evidence of intervention impact for 3-month, 1-month, and 7-day abstinence and duration since last cigarette (P = .09, .015, .01, and .03, respectively). The intervention effect was strongest among male daily smokers and among female less-than-daily smokers. Conclusions Proactive identification and recruitment of adolescents via public high schools can produce a high level of intervention reach; a personalized motivational interviewing plus cognitive behavioral skills training counseling intervention delivered by counselor-initiated telephone calls is effective in increasing teen smoking cessation; and both daily and less-than-daily teen smokers participate in and benefit from telephone-based smoking cessation intervention. PMID:19822836

  2. Meditation or Exercise for Preventing Acute Respiratory Infection: A Randomized Controlled Trial

    PubMed Central

    Barrett, Bruce; Hayney, Mary S.; Muller, Daniel; Rakel, David; Ward, Ann; Obasi, Chidi N.; Brown, Roger; Zhang, Zhengjun; Zgierska, Aleksandra; Gern, James; West, Rebecca; Ewers, Tola; Barlow, Shari; Gassman, Michele; Coe, Christopher L.

    2012-01-01

    PURPOSE This study was designed to evaluate potential preventive effects of meditation or exercise on incidence, duration, and severity of acute respiratory infection (ARI) illness. METHODS Community-recruited adults aged 50 years and older were randomized to 1 of 3 study groups: 8-week training in mindfulness meditation, matched 8-week training in moderate-intensity sustained exercise, or observational control. The primary outcome was area-under-the-curve global illness severity during a single cold and influenza season, using the Wisconsin Upper Respiratory Symptom Survey (WURSS-24) to assess severity. Health care visits and days of missed work were counted. Nasal wash collected during ARI illness was assayed for neutrophils, interleukin-8, and viral nucleic acid. RESULTS Of 154 adults randomized into the study, 149 completed the trial (82% female, 94% white, mean age 59.3 ± 6.6 years). There were 27 ARI episodes and 257 days of ARI illness in the meditation group (n = 51), 26 episodes and 241 illness days in the exercise group (n = 47), and 40 episodes and 453 days in the control group (n = 51). Mean global severity was 144 for meditation, 248 for exercise, and 358 for control. Compared with control, global severity was significantly lower for meditation (P = .004). Both global severity and total days of illness (duration) trended toward being lower for the exercise group (P=.16 and P=.032, respectively), as did illness duration for the meditation group (P=.034). Adjusting for covariates using zero-inflated multivariate regression models gave similar results. There were 67 ARI-related days of-work missed in the control group, 32 in the exercise group (P = .041), and 16 in the meditation group (P <.001). Health care visits did not differ significantly. Viruses were identified in 54% of samples from meditation, 42% from exercise, and 54% from control groups. Neutrophil count and interleukin-8 levels were similar among intervention groups. CONCLUSIONS Training in

  3. A Randomized Parallel-Group Dietary Study for Stage II–IV Ovarian Cancer Survivors

    PubMed Central

    Paxton, Raheem J.; Garcia-Prieto, Celia; Berglund, Maria; Hernandez, Mike; Hejek, Richard A.; Handy, Beverly; Brown, Jubilee; Jones, Lovell A.

    2011-01-01

    Background Few studies have examined the dietary habits of ovarian cancer survivors. Therefore, we conducted a study to assess the feasibility and impact of two dietary interventions for ovarian cancer survivors. Methods In this randomized, parallel-group study, 51 women (mean age, 53 years) diagnosed with stage II–IV ovarian cancer were recruited and randomly assigned to a low fat, high fiber (LFHF) diet or a modified National Cancer Institute diet supplemented with a soy-based beverage and encapsulated fruit and vegetable juice concentrates (FVJCs). Changes in clinical measures, serum carotenoid and tocopherol levels, dietary intake, anthropometry, and health-related quality of life (HRQOL) were assessed with paired t-tests. Results The recruitment rate was 25%, and the retention rate was 75% at 6 months. At baseline, 28% and 45% of women met guidelines for intake of fiber and of fruits and vegetables, respectively. After 6 months, total serum carotenoid levels and α- and β-carotene concentrations were significantly increased in both groups (P < 0.01); however, β-carotene concentrations were increased more in the FVJC group. Serum β-cryptoxanthin levels, fiber intake (+5.2 g/day), and daily servings of juice (+0.9 servings/day) and vegetables (+1.3 servings/day) were all significantly increased in the LFHF group (all P < 0.05). Serum levels of albumin, lutein and zeaxanthin, retinol, and retinyl palmitate were significantly increased in the FVJC group (all P < 0.05). No changes in cancer antigen-125, anthropometry, or HRQOL were observed. Conclusion Overall, this study supports the feasibility of designing dietary interventions for stage II–IV ovarian cancer survivors and provides preliminary evidence that a low fat high fiber diet and a diet supplemented with encapsulated FVJC may increase phytonutrients in ovarian cancer survivors. PMID:22119991

  4. Effects of hypnosis as an adjunct to intravenous sedation for third molar extraction: a randomized, blind, controlled study.

    PubMed

    Mackey, Edward F

    2010-01-01

    The effects of hypnosis/therapeutic suggestion in connection with intravenous sedation and surgery have been described in many clinical publications; however, few randomized, controlled, and blind studies have been performed in the outpatient area. This study aimed to evaluate the use of hypnosis/therapeutic suggestion as an adjunct to intravenous (IV) sedation in patients having 3rd molar removal in an outpatient setting. The patients were randomly assigned to a treatment (n = 46) or control (n = 54) group. The treatment group listened to a rapid conversational induction and therapeutic suggestions via headphones throughout the entire surgical procedure along with a standard sedation dose of intravenous anesthetic. The control group listened to only music without any hypnotic intervention. Intraoperative Propofol administration, patient postoperative pain ratings, and postoperative prescription pain reliever consumption were all significantly reduced in the treatment compared to the control group. Implications of these results are discussed. PMID:20183736

  5. Building social resilience in soldiers: A double dissociative randomized controlled study.

    PubMed

    Cacioppo, John T; Adler, Amy B; Lester, Paul B; McGurk, Dennis; Thomas, Jeffrey L; Chen, Hsi-Yuan; Cacioppo, Stephanie

    2015-07-01

    Can social resilience be trained? We report results of a double-dissociative randomized controlled study in which 48 Army platoons were randomly assigned to social resilience training (intervention condition) or cultural awareness training (active control group). The same surveys were administered to all platoons at baseline and after the completion of training to determine the short-term training effects, generalization effects beyond training, and possible adverse effects. Multilevel modeling analyses indicated that social resilience, compared with cultural awareness, training produced small but significant improvements in social cognition (e.g., increased empathy, perspective taking, & military hardiness) and decreased loneliness, but no evidence was found for social resilience training to generalize beyond these training foci nor to have adverse effects. Moreover, as predicted, cultural awareness, compared with social resilience, training produced increases in knowledge about and decreases in prejudice toward Afghans. Additional research is warranted to determine the long-term durability, safety, and generalizability of social resilience training. PMID:26098588

  6. The electrically and magnetically controllable random laser from dye-doped liquid crystals

    NASA Astrophysics Data System (ADS)

    Ye, Lihua; Liu, Bo; Zhao, Chong; Wang, Yan; Cui, Yiping; Lu, Yanqing

    2014-08-01

    The electrically and magnetically controllable random laser from dye-doped liquid crystals (LCs) was studied. The rubbing-alignment of the polyimide in the LC cell influenced the threshold voltage and the response time of the electrically controllable random laser. When the applied electric field was increased, the response time of the random laser decreased. The magnetically controllable random laser was studied in the hollow fiber structure, of which the response time was less than 1 s.

  7. Randomized, Controlled Trial of an Intervention for Toddlers With Autism: The Early Start Denver Model

    PubMed Central

    Dawson, Geraldine; Rogers, Sally; Munson, Jeffrey; Smith, Milani; Winter, Jamie; Greenson, Jessica; Donaldson, Amy; Varley, Jennifer

    2016-01-01

    OBJECTIVE To conduct a randomized, controlled trial to evaluate the efficacy of the Early Start Denver Model (ESDM), a comprehensive developmental behavioral intervention, for improving outcomes of toddlers diagnosed with autism spectrum disorder (ASD). METHODS Forty-eight children diagnosed with ASD between 18 and 30 months of age were randomly assigned to 1 of 2 groups: (1) ESDM intervention, which is based on developmental and applied behavioral analytic principles and delivered by trained therapists and parents for 2 years; or (2) referral to community providers for intervention commonly available in the community. RESULTS Compared with children who received community-intervention, children who received ESDM showed significant improvements in IQ, adaptive behavior, and autism diagnosis. Two years after entering intervention, the ESDM group on average improved 17.6 standard score points (1 SD:15 points) compared with 7.0 points in the comparison group relative to baseline scores. The ESDM group maintained its rate of grow thin adaptive behavior compared with a normative sample of typically developing children. In contrast, over the 2-year span, the comparison group showed greater delays in adaptive behavior. Children who received ESDM also were more likely to experience a change in diagnosis from autism to pervasive developmental disorder, not otherwise specified, than the comparison group. CONCLUSIONS This is the first randomized, controlled trial to demonstrate the efficacy of a comprehensive developmental behavioral intervention for toddlers with ASD for improving cognitive and adaptive behavior and reducing severity of ASD diagnosis. Results of this study underscore the importance of early detection of and intervention in autism. PMID:19948568

  8. Intradialytic Massage for Leg Cramps Among Hemodialysis Patients: a Pilot Randomized Controlled Trial

    PubMed Central

    Mastnardo, Diane; Lewis, Janice M.; Hall, Kristi; Sullivan, Catherine M.; Cain, Katrice; Theurer, Jacqueline; Huml, Anne; Sehgal, Ashwini R.

    2016-01-01

    Background Patients on hemodialysis often experience muscle cramps that result in discomfort, shortened treatment times, and inadequate dialysis dose. Cramps have been associated with adversely affecting sleep and health-related quality of life, depression and anxiety. There is limited evidence available about massage in dialysis; however, massage in cancer patients has demonstrated decreases in pain, inflammation, and feelings of anxiety. These correlations indicate massage may be an effective treatment modality for hemodialysis-related lower extremity cramping. Purpose To determine the effectiveness of intradialytic massage on the frequency of cramping among hemodialysis patients prone to lower extremity cramping. Participants 26 maintenance hemodialysis patients with frequent lower extremity cramps. Setting three outpatient hemodialysis centers in Northeast Ohio. Research Design randomized controlled trial. Intervention The intervention group received a 20-minute massage of the lower extremities during each treatment (three times per week) for two weeks. The control group received usual care by dialysis center staff. Main Outcome Measure change in frequency of lower leg cramping. Results Patient reported cramping at home decreased by 1.3 episodes per week in the intervention group compared to 0.2 episodes per week in the control group (p=.005). Patient reported cramping during dialysis decreased by 0.8 episodes in the intervention group compared to 0.4 episodes in the control group (p=0.44). Conclusion Intradialytic massage appears to be an effective way to address muscle cramping. Larger studies with longer duration should be conducted to further examine this approach. PMID:27257445

  9. Randomized controlled trial of a nonpharmacologic cholesterol reduction program at the worksite.

    PubMed

    Bruno, R; Arnold, C; Jacobson, L; Winick, M; Wynder, E

    1983-07-01

    Under experimental clinical conditions diet modification has been shown to reduce serum cholesterol levels. This paper reports such a positive response to a nonpharmacologic, behavioral education program at the worksite. Employees at the New York Telephone Company corporate headquarters were assigned randomly to treatment and control groups. Treatment consisted of an 8-week group cholesterol reduction program conducted during employee lunch hours. It comprised a multiple-treatment approach--food behavior change techniques combined with nutrition education, physical activity planning, and self-management skills. The treatment group showed substantial change compared with the control group at the program's completion. Those treated displayed a significant 6.4% reduction in total serum cholesterol (266 mg% average at baseline) as compared with control subjects with a corresponding decrease in high-density lipoprotein levels. A significant increase in nutrition knowledge and moderate weight loss were also documented for this group. The magnitudes of a participant's baseline serum cholesterol level and his/her reduction in percentage of ideal body weight were positively and independently correlated with percentage changes in serum cholesterol levels. Over the same period, decreases in high-density lipoprotein levels and no changes in serum cholesterol, weight, and nutrition knowledge were observed for the control group. Overall, participants in the treatment program successfully reduced the coronary heart disease risk factors of elevated cholesterol and weight. Directions for future study are suggested. PMID:6622436

  10. Biofeedback Intervention for Stress and Anxiety among Nursing Students: A Randomized Controlled Trial.

    PubMed

    Ratanasiripong, Paul; Ratanasiripong, Nop; Kathalae, Duangrat

    2012-01-01

    Purpose. It has been well documented that nursing students across the world experience stress and anxiety throughout their education and training. The purpose of this randomized controlled study is to investigate the impact of biofeedback intervention program on nursing students' levels of stress and anxiety during their first clinical training. Methods. Participants consisted of 60 second-year baccalaureate nursing students. The 30 participants in the biofeedback group received training on how to use the biofeedback device to assist in stress and anxiety management for 5 weeks while the 30 in the control group did not receive any training. Findings. Results indicated that the biofeedback group was able to maintain the stress level while the control group had a significant increase in the stress level over the 5-week period of clinical training. Additionally, the biofeedback group had a significant reduction in anxiety, while the control group had a moderate increase in anxiety. Conclusions. The better the nursing students can manage their stress and anxiety, the more successful they can be in their clinical training. Ultimately, the more psychologically healthy the nursing students are, the more likely they will flourish and graduate to become productive and contributing members of the nursing profession. PMID:22811932

  11. A randomized controlled trial of analgesia during vaccination in adults.

    PubMed

    Taddio, Anna; Lord, Allison; Hogan, Mary-Ellen; Kikuta, Andrew; Yiu, Ashley; Darra, Erwin; Bruinse, Barbara; Keogh, Tom; Stephens, Derek

    2010-07-19

    Although immunization injections are the most common painful medical procedures, pain-relieving interventions are not routinely used. In this randomized controlled trial, we compared the effectiveness of topical anesthesia using liposomal lidocaine to: (1) vapocoolant spray using a proprietary blend of 1,1,1,3,3-pentafluoropropane and 1,1,1,2-tetrafluoroethane; (2) nurse-administered tactile stimulation; or (3) self-directed distraction by means of reading a magazine. Liposomal lidocaine was more effective (p

  12. Parent Training for Young Children With Developmental Disabilities: Randomized Controlled Trial

    PubMed Central

    McIntyre, Laura Lee

    2009-01-01

    A randomized controlled trial was used to evaluate a parent training intervention for caregivers with preschool-age children with developmental disabilities. The 21 families in the experimental group received usual care plus the 12-week Incredible Years Parent Training Program with developmental delay modifications. Families in the control group (n = 23) received usual care, including early childhood education and related services. Results suggest that this parent training intervention was superior to usual care for young children with developmental delays or disabilities in reducing negative parent–child interactions and child behavior problems. Participants in the experimental group indicated high satisfaction with treatment. Additional research is necessary to document maintenance and generalization of treatment outcomes. PMID:18702556

  13. A Yoga Intervention for Posttraumatic Stress: A Preliminary Randomized Control Trial

    PubMed Central

    Jindani, Farah; Turner, Nigel; Khalsa, Sat Bir S.

    2015-01-01

    Yoga may be effective in the reduction of PTSD symptomology. The purpose of this study was to evaluate the impact of a Kundalini Yoga (KY) treatment on PTSD symptoms and overall wellbeing. To supplement the current field of inquiry, a pilot randomized control trial (RCT) was conducted comparing an 8-session KY intervention with a waitlist control group. 80 individuals with current PTSD symptoms participated. Both groups demonstrated changes in PTSD symptomology but yoga participants showed greater changes in measures of sleep, positive affect, perceived stress, anxiety, stress, and resilience. Between-groups effect sizes were small to moderate (0.09–0.25). KY may be an adjunctive or alternative intervention for PTSD. Findings indicate the need for further yoga research to better understand the mechanism of yoga in relation to mental and physical health, gender and ethnic comparisons, and short- and long-term yoga practice for psychiatric conditions. PMID:26366179

  14. The Effectiveness of Cupping Therapy on Relieving Chronic Neck and Shoulder Pain: A Randomized Controlled Trial.

    PubMed

    Chi, Lee-Mei; Lin, Li-Mei; Chen, Chien-Lin; Wang, Shu-Fang; Lai, Hui-Ling; Peng, Tai-Chu

    2016-01-01

    The research aimed to investigate the effectiveness of cupping therapy (CT) in changes on skin surface temperature (SST) for relieving chronic neck and shoulder pain (NSP) among community residents. A single-blind experimental design constituted of sixty subjects with self-perceived NSP. The subjects were randomly allocated to two groups. The cupping group received CT at SI 15, GB 21, and LI 15 acupuncture points, and the control group received no intervention. Pain was assessed using the SST, visual analog scale (VAS), and blood pressure (BP). The main results were SST of GB 21 acupuncture point raised from 30.6°C to 32.7°C and from 30.7°C to 30.6°C in the control group. Neck pain intensity (NPI) severity scores were reduced from 9.7 to 3.6 in the cupping group and from 9.7 to 9.5 in the control group. The SST and NPI differences between the groups were statistically significant (P < 0.001). One treatment of CT is shown to increase SST. In conjunction with the physiological effect the subjective experience of NSP is reduced in intensity. Further studies are required to improve the understanding and potential long-term effects of CT. PMID:27073404

  15. Clinical and Immunological Changes of Immunotherapy in Patients with Atopic Dermatitis: Randomized Controlled Trial

    PubMed Central

    Sánchez Caraballo, Jorge Mario; Cardona Villa, Ricardo

    2012-01-01

    Background. Immunotherapy has proven to be an useful tool in the management of allergic respiratory diseases; however, little has been studied in atopic dermatitis. Objective. To evaluate the clinical and immunological impact of immunotherapy with mites allergen extracts in atopic dermatitis. Methods. Patients with atopic dermatitis were assigned with computer-generated randomization to either of the following groups: (a) controls received only topical treatment with steroids and/or tacrolimus and (b) actively treated patients received topical treatment plus immunotherapy. Levels of serum total IgE, mites-specific IgE and IgG4 were assessed at study start and after one year of immunotherapy. Results. 31 patients in the active group and 29 in the control group completed the study. Symptoms and medication scores were significantly reduced in the active group after six months. Three patients in the control group showed new sensitizations to mites, while 3 patients in the active group showed neosensitization to shrimp with negative oral food challenge. We observed significant increase of mites-specific IgG4 levels in active group. Conclusion. Specific allergen immunotherapy induced a tolerogenic IgG4 response to mite allergens associated with favorable clinical effects in atopic dermatitis patients. PMID:23724240

  16. Adapted motivational interviewing for women with binge eating disorder: a randomized controlled trial.

    PubMed

    Cassin, Stephanie E; von Ranson, Kristin M; Heng, Kenneth; Brar, Joti; Wojtowicz, Amy E

    2008-09-01

    In this randomized controlled trial, 108 women with binge-eating disorder (BED) recruited from the community were assigned to either an adapted motivational interviewing (AMI) group (1 individual AMI session + self-help handbook) or control group (handbook only). They were phoned 4, 8, and 16 weeks following the initial session to assess binge eating and associated symptoms (depression, self-esteem, quality of life). Postintervention, the AMI group participants were more confident than those in the control group in their ability to change binge eating. Although both groups reported improved binge eating, mood, self-esteem, and general quality of life 16 weeks following the intervention, the AMI group improved to a greater extent. A greater proportion of women in the AMI group abstained from binge eating (27.8% vs. 11.1%) and no longer met the binge frequency criterion of the Diagnostic and Statistical Manual of Mental Disorders (4th ed., text rev.; American Psychiatric Association, 2000) for BED (87.0% vs. 57.4%). AMI may constitute a brief, effective intervention for BED and associated symptoms. PMID:18778135

  17. The Effectiveness of Cupping Therapy on Relieving Chronic Neck and Shoulder Pain: A Randomized Controlled Trial

    PubMed Central

    Chi, Lee-Mei; Lin, Li-Mei; Chen, Chien-Lin; Wang, Shu-Fang; Lai, Hui-Ling; Peng, Tai-Chu

    2016-01-01

    The research aimed to investigate the effectiveness of cupping therapy (CT) in changes on skin surface temperature (SST) for relieving chronic neck and shoulder pain (NSP) among community residents. A single-blind experimental design constituted of sixty subjects with self-perceived NSP. The subjects were randomly allocated to two groups. The cupping group received CT at SI 15, GB 21, and LI 15 acupuncture points, and the control group received no intervention. Pain was assessed using the SST, visual analog scale (VAS), and blood pressure (BP). The main results were SST of GB 21 acupuncture point raised from 30.6°C to 32.7°C and from 30.7°C to 30.6°C in the control group. Neck pain intensity (NPI) severity scores were reduced from 9.7 to 3.6 in the cupping group and from 9.7 to 9.5 in the control group. The SST and NPI differences between the groups were statistically significant (P < 0.001). One treatment of CT is shown to increase SST. In conjunction with the physiological effect the subjective experience of NSP is reduced in intensity. Further studies are required to improve the understanding and potential long-term effects of CT. PMID:27073404

  18. The Effect of External Apple Vinegar Application on Varicosity Symptoms, Pain, and Social Appearance Anxiety: A Randomized Controlled Trial

    PubMed Central

    Atik, Derya; Atik, Cem; Karatepe, Celalettin

    2016-01-01

    Aim. We aimed to determine the effect of external apple vinegar application on the symptoms and social appearance anxiety of varicosity patients who were suggested conservative treatment. Method. The study was planned as an experimental, randomized, and controlled study. 120 patients were randomly selected and then were randomly allocated to either experimental or control group by simple blind random sampling method. In the collection of research data, a questionnaire questioning sociodemographic and clinical characteristics, the Visual Analog Scale (VAS) for pain, and the Social Appearance Anxiety Scale (SAAS) were used. The patients in the study group were suggested to apply apple vinegar to the area of the leg with varicosity alongside the treatment suggested by the doctor. The patients in the control group received no intervention during the study. Results. The sociodemographic and clinic characteristics of both groups were found to be similar (p > 0.05). The patients were evaluated with regard to cramps, pain, leg fatigue perception, edema, itching, pigmentation, and weight feelings in the leg, VAS, and SAAS averages in the second evaluation; the control group had a decrease in such symptoms (p > 0.05) although the decrease in the application group was higher and statistically meaningful (p < 0.05). Conclusion. We determined that the external application of apple vinegar on varicosity patients, which is a very easy application, increased the positive effects of conservative treatment. PMID:26881006

  19. Outcomes in Registered, Ongoing Randomized Controlled Trials of Patient Education

    PubMed Central

    Pino, Cécile; Boutron, Isabelle; Ravaud, Philippe

    2012-01-01

    Background With the increasing prevalence of chronic noncommunicable diseases, patient education is becoming important to strengthen disease prevention and control. We aimed to systematically determine the extent to which registered, ongoing randomized controlled trials (RCTs) evaluated an educational intervention focus on patient-important outcomes (i.e., outcomes measuring patient health status and quality of life). Methods On May 6, 2009, we searched for all ongoing RCTs registered in the World Health Organization International Clinical Trials Registry platform. We used a standardized data extraction form to collect data and determined whether the outcomes assessed were 1) patient-important outcomes such as clinical events, functional status, pain, or quality of life or 2) surrogate outcomes, such as biological outcome, treatment adherence, or patient knowledge. Principal Findings We selected 268 of the 642 potentially eligible studies and assessed a random sample of 150. Patient-important outcomes represented 54% (178 of 333) of all primary outcomes and 46% (286 of 623) of all secondary outcomes. Overall, 69% of trials (104 of 150) used at least one patient-important outcome as a primary outcome and 66% (99 of 150) as a secondary outcome. Finally, for 31% of trials (46 of 150), primary outcomes were only surrogate outcomes. The results varied by medical area. In neuropsychiatric disorders, patient important outcomes represented 84% (51 of 61) of primary outcomes, as compared with 54% (32 of 59) in malignant neoplasm and 18% (4 of 22) in diabetes mellitus trials. In addition, only 35% assessed the long-term impact of interventions (i.e., >6 months). Conclusions There is a need to improve the relevance of outcomes and to assess the long term impact of educational interventions in RCTs. PMID:22916183

  20. Using community readiness key informant assessments in a randomized group prevention trial: impact of a participatory community-media intervention.

    PubMed

    Slater, Michael D; Edwards, Ruth W; Plested, Barbara A; Thurman, Pamela J; Kelly, Kathleen J; Comello, Maria Leonora G; Keefe, Thomas J

    2005-02-01

    This study examines the role of key informant community readiness assessments in a randomized group trial testing the impact of a participatory community-media intervention (which was also complemented by in-school efforts). These assessments were used to help match communities in random assignment, as a source of formative data about the community, as the basis for a coalition-building workshop, and as an evaluation tool, with a follow-up set of surveys approximately 2 years after the baseline survey. Results of the nested, random effects analysis indicated that the intervention influenced community knowledge of efforts and (at marginally significant levels) improved prevention leadership quality and community climate supportive of prevention efforts. There was evidence that the professional affiliation of informants in some cases had an effect on their assessments, which could be controlled in the analysis. The authors conclude that key informant community readiness assessments can usefully serve to supplement aggregated measures of individual attitudes and behavior (reported elsewhere for this study) in evaluating community-based interventions. PMID:15751598

  1. A Randomized Controlled Trial of Mindfulness Meditation for Chronic Insomnia

    PubMed Central

    Ong, Jason C.; Manber, Rachel; Segal, Zindel; Xia, Yinglin; Shapiro, Shauna; Wyatt, James K.

    2014-01-01

    Study Objectives: To evaluate the efficacy of mindfulness meditation for the treatment of chronic insomnia. Design: Three-arm, single-site, randomized controlled trial. Setting: Academic medical center. Participants: Fifty-four adults with chronic insomnia. Interventions: Participants were randomized to either mindfulness-based stress reduction (MBSR), mindfulness-based therapy for insomnia (MBTI), or an eight-week self-monitoring (SM) condition. Measurements and Results: Patient-reported outcome measures were total wake time (TWT) from sleep diaries, the pre-sleep arousal scale (PSAS), measuring a prominent waking correlate of insomnia, and the Insomnia Severity Index (ISI) to determine remission and response as clinical endpoints. Objective sleep measures were derived from laboratory polysomnography and wrist actigraphy. Linear mixed models showed that those receiving a meditation-based intervention (MBSR or MBTI) had significantly greater reductions on TWT minutes (43.75 vs 1.09), PSAS (7.13 vs 0.16), and ISI (4.56 vs 0.06) from baseline-to-post compared to SM. Post hoc analyses revealed that each intervention was superior to SM on each of the patient-reported measures, but no significant differences were found when comparing MBSR to MBTI from baseline-to-post. From baseline to 6-month follow-up, MBTI had greater reductions in ISI scores than MBSR (P < 0.05), with the largest difference occurring at the 3-month follow-up. Remission and response rates in MBTI and MBSR were sustained from post-treatment through follow-up, with MBTI showing the highest rates of treatment remission (50%) and response (78.6%) at the 6-month follow-up. Conclusions: Mindfulness meditation appears to be a viable treatment option for adults with chronic insomnia and could provide an alternative to traditional treatments for insomnia. Trial Registration: Mindfulness-Based Approaches to Insomnia: clinicaltrials.gov, identifier: NCT00768781 Citation: Ong JC, Manber R, Segal Z, Xia Y

  2. Safety of polyethylene glycol 3350 solution in chronic constipation: randomized, placebo-controlled trial

    PubMed Central

    McGraw, Thomas

    2016-01-01

    Purpose To evaluate the safety and tolerability of aqueous solution concentrate (ASC) of polyethylene glycol (PEG) 3350 in patients with functional constipation. Patients and methods The patients who met Rome III diagnostic criteria for functional constipation were randomized in this multicenter, randomized, placebo-controlled, single-blind study to receive once daily dose of PEG 3350 (17 g) ASC or placebo solution for 14 days. The study comprised a screening period (visit 1), endoscopy procedure (visits 2 and 3), and followup telephone calls 30 days post-treatment. Safety end points included adverse events (AEs), clinical laboratory evaluations, vital signs, and others. The primary end points were the proportion of patients with abnormalities of the oral and esophageal mucosa, detected by visual and endoscopic examination of the oral cavity and esophagus, respectively, compared with placebo. A secondary objective was to compare the safety and tolerability of ASC by evaluating AEs or adverse drug reactions. Results A total of 65 patients were enrolled in this study, 31 were randomized to PEG 3350 ASC and 34 were randomized to placebo, of which 62 patients completed the study. No patients in either group showed abnormalities in inflammation of the oral mucosa during visit 2 (before treatment) or visit 3 (after treatment). Fewer abnormalities of the esophageal mucosa were observed in the PEG 3350 ASC group than in the placebo group on visit 3, with no significant difference in the proportion of abnormalities between the treatment groups. Overall, 40 treatment-emergent AEs were observed in 48.4% of patients treated with PEG 3350 ASC, and 41 treatment-emergent AEs were observed in 55.9% of patients treated with placebo – nonsignificant difference of −7.5% (95% CI: −21.3, 6.3) between treatment groups. No serious AEs or deaths were reported, and no patient discontinued because of an AE. Conclusion PEG 3350 ASC is safe and well tolerated in patients with functional

  3. Efficacy of Continuous S(+)-Ketamine Infusion for Postoperative Pain Control: A Randomized Placebo-Controlled Trial

    PubMed Central

    Miziara, Luiz Eduardo de Paula Gomes; Simoni, Ricardo Francisco; Esteves, Luís Otávio; Cangiani, Luis Henrique; Grillo-Filho, Gil Fernando Ribeiro; Paula, Anderson Garcia Lima e

    2016-01-01

    Aim. A double-blind, randomized, placebo-controlled trial was designed to evaluate the efficacy of continuous intraoperative infusion of S(+)-ketamine under intravenous anesthesia with target-controlled infusion of remifentanil and propofol for postoperative pain control. Methods. Forty-eight patients undergoing laparoscopic cholecystectomy were assigned to receive continuous S(+)-ketamine infusion at a rate of 0.3 mg·kg−1·h−1 (n = 24, intervention group) or an equivalent volume of saline at the same rate (n = 24, placebo group). The same target-controlled intravenous anesthesia was induced in both groups. Pain was assessed using a 0 to 10 verbal numeric rating scale during the first 12 postoperative hours. Pain scores and morphine consumption were recorded in the postanesthesia care unit (PACU) and at 4 and 12 hours after surgery. Results. Pain scores were lower in the intervention group at all time points. Morphine consumption did not differ significantly between groups during PACU stay, but it was significantly lower in the intervention group at each time point after PACU discharge (P = 0.0061). At 12 hours after surgery, cumulative morphine consumption was also lower in the intervention group (5.200 ± 2.707) than in the placebo group (7.525 ± 1.872). Conclusions. Continuous S(+)-ketamine infusion during laparoscopic cholecystectomy under target-controlled intravenous anesthesia provided better postoperative pain control than placebo, reducing morphine requirement. Trial Registration. This trial is registered with ClinicalTrials.gov NCT02421913. PMID:26949390

  4. Efficacy of Continuous S(+)-Ketamine Infusion for Postoperative Pain Control: A Randomized Placebo-Controlled Trial.

    PubMed

    Miziara, Luiz Eduardo de Paula Gomes; Simoni, Ricardo Francisco; Esteves, Luís Otávio; Cangiani, Luis Henrique; Grillo-Filho, Gil Fernando Ribeiro; Paula, Anderson Garcia Lima E

    2016-01-01

    Aim. A double-blind, randomized, placebo-controlled trial was designed to evaluate the efficacy of continuous intraoperative infusion of S(+)-ketamine under intravenous anesthesia with target-controlled infusion of remifentanil and propofol for postoperative pain control. Methods. Forty-eight patients undergoing laparoscopic cholecystectomy were assigned to receive continuous S(+)-ketamine infusion at a rate of 0.3 mg·kg(-1)·h(-1) (n = 24, intervention group) or an equivalent volume of saline at the same rate (n = 24, placebo group). The same target-controlled intravenous anesthesia was induced in both groups. Pain was assessed using a 0 to 10 verbal numeric rating scale during the first 12 postoperative hours. Pain scores and morphine consumption were recorded in the postanesthesia care unit (PACU) and at 4 and 12 hours after surgery. Results. Pain scores were lower in the intervention group at all time points. Morphine consumption did not differ significantly between groups during PACU stay, but it was significantly lower in the intervention group at each time point after PACU discharge (P = 0.0061). At 12 hours after surgery, cumulative morphine consumption was also lower in the intervention group (5.200 ± 2.707) than in the placebo group (7.525 ± 1.872). Conclusions. Continuous S(+)-ketamine infusion during laparoscopic cholecystectomy under target-controlled intravenous anesthesia provided better postoperative pain control than placebo, reducing morphine requirement. Trial Registration. This trial is registered with ClinicalTrials.gov NCT02421913. PMID:26949390

  5. Comprehensive rehabilitation with integrative medicine for subacute stroke: A multicenter randomized controlled trial.

    PubMed

    Fang, Jianqiao; Chen, Lifang; Ma, Ruijie; Keeler, Crystal Lynn; Shen, Laihua; Bao, Yehua; Xu, Shouyu

    2016-01-01

    To determine whether integrative medicine rehabilitation (IMR) that combines conventional rehabilitation (CR) with acupuncture and Chinese herbal medicine has better effects for subacute stroke than CR alone, we conducted a multicenter randomized controlled trial that involved three hospitals in China. Three hundred sixty patients with subacute stroke were randomized into IMR and CR groups. The primary outcome was the Modified Barthel Index (MBI). The secondary outcomes were the National Institutes of Health Stroke Scale (NIHSS), the Fugl-Meyer Assessment (FMA), the mini-mental state examination (MMSE), the Montreal Cognitive Assessment (MoCA), Hamilton's Depression Scale (HAMD), and the Self-Rating Depression Scale (SDS). All variables were evaluated at week 0 (baseline), week 4 (half-way of intervention), week 8 (after treatment) and week 20 (follow-up). In comparison with the CR group, the IMR group had significantly better improvements (P < 0.01 or P < 0.05) in all the primary and secondary outcomes. There were also significantly better changes from baseline in theses outcomes in the IMR group than in the CR group (P < 0.01). A low incidence of adverse events with mild symptoms was observed in the IMR group. We conclude that conventional rehabilitation combined with integrative medicine is safe and more effective for subacute stroke rehabilitation. PMID:27174221

  6. Comprehensive rehabilitation with integrative medicine for subacute stroke: A multicenter randomized controlled trial

    PubMed Central

    Fang, Jianqiao; Chen, Lifang; Ma, Ruijie; Keeler, Crystal Lynn; Shen, Laihua; Bao, Yehua; Xu, Shouyu

    2016-01-01

    To determine whether integrative medicine rehabilitation (IMR) that combines conventional rehabilitation (CR) with acupuncture and Chinese herbal medicine has better effects for subacute stroke than CR alone, we conducted a multicenter randomized controlled trial that involved three hospitals in China. Three hundred sixty patients with subacute stroke were randomized into IMR and CR groups. The primary outcome was the Modified Barthel Index (MBI). The secondary outcomes were the National Institutes of Health Stroke Scale (NIHSS), the Fugl-Meyer Assessment (FMA), the mini-mental state examination (MMSE), the Montreal Cognitive Assessment (MoCA), Hamilton’s Depression Scale (HAMD), and the Self-Rating Depression Scale (SDS). All variables were evaluated at week 0 (baseline), week 4 (half-way of intervention), week 8 (after treatment) and week 20 (follow-up). In comparison with the CR group, the IMR group had significantly better improvements (P < 0.01 or P < 0.05) in all the primary and secondary outcomes. There were also significantly better changes from baseline in theses outcomes in the IMR group than in the CR group (P < 0.01). A low incidence of adverse events with mild symptoms was observed in the IMR group. We conclude that conventional rehabilitation combined with integrative medicine is safe and more effective for subacute stroke rehabilitation. PMID:27174221

  7. Nurse Case Management and Housing Interventions Reduce Allergen Exposures: The Milwaukee Randomized Controlled Trial

    PubMed Central

    Breysse, Jill; Wendt, Jean; Dixon, Sherry; Murphy, Amy; Wilson, Jonathan; Meurer, John; Cohn, Jennifer; Jacobs, David E.

    2011-01-01

    Objective We examined the impact of a combination of home environmental interventions and nurse case management services on total settled dust loadings and on allergen concentrations in the homes of asthmatic children. Methods Using a randomized longitudinal controlled trial study design, we randomly assigned homes of asthmatic children in Milwaukee to either a control (n=64) or an intervention (n=57) group. Control group homes received a visual assessment, education, bed/pillow dust mite encasings, and treatment of lead-based paint hazards. The intervention group received these same services plus nurse case management that included tailored, individual asthma action plans, provision of minor home repairs, home cleaning using special vacuuming and wet washing, and integrated pest management. Dust vacuum samples were collected from measured surface areas of floors in the TV room, kitchen, and child's bedroom at baseline and at three-, six-, and 12-month follow-up visits. Dust loading (mass per surface area) is a means of measuring total dust and the total amount of allergen present. Results For the intervention group, geometric mean dust loadings declined significantly from baseline (39 milligrams per square foot [mg/ft2]) to post-intervention (11 mg/ft2) (p<0.001). Baseline dust loading, treatment group, visit, and season were significant predictors of follow-up dust loadings. Mean post-intervention dust loadings were 72% higher in the control group. The total amount of allergen in settled house dust declined significantly following the intervention because total dust loading declined; the concentration of allergens in settled dust did not change significantly. Conclusion The combination of nurse case management and home environmental interventions promotes collaboration between health and housing professionals and is effective in reducing exposures to allergens in settled dust. PMID:21563716

  8. Foot Massage and Physiological Stress in People with Dementia: A Randomized Controlled Trial

    PubMed Central

    Cooke, Marie Louise; Beattie, Elizabeth; Shum, David H.K.; O'Dwyer, Siobhan T.; Barrett, Sue; Sung, Billy

    2014-01-01

    Abstract Background: The anxiety associated with unfamiliar surroundings, the disorientation and mental confusion, and the social isolation that accompanies dementia can often create increased stress for people living in long-term care settings. Such a response is thought to affect the autonomic nervous system and result in emotional and physical symptoms of distress that may be manifested as agitation. There is the potential for such distress to influence the physiological response and in particular Blood Pressure and Heart Rate. A relaxation intervention such as massage may influence the physiological stress response. Methods: This randomized controlled trial aimed to compare the effect of foot massage (FM) versus a control activity (quiet presence, QP) on physiological stress response (i.e., blood pressure [BP] and heart rate [HR]) in people living with moderate-to-severe dementia in long-term-care settings. Results: Fifty-three residents were randomized to intervention (10-minute FM) or control group (QP). While the FM group experienced a greater reduction in HR than the control group, these reductions were not significantly different between groups (p=0.83; see Table 1), or across time (p=0.46). Both groups experienced a reduction in systolic BP and diastolic BP, while the mean reduction in systolic BP was greater for those in the FM group. Conclusions: While the findings do not provide strong support for FM, the finding that both conditions allowed the person with dementia to rest in the presence of another human being is of importance in the care of people with dementia. The close presence of another person may in fact promote relaxation and therefore improve BP and HR measures. PMID:24047244

  9. A Multifactorial Weight Reduction Programme for Children with Overweight and Asthma: A Randomized Controlled Trial

    PubMed Central

    Willeboordse, Maartje; van de Kant, Kim D. G.; Tan, Frans E. S.; Mulkens, Sandra; Schellings, Julia; Crijns, Yvonne; van der Ploeg, Liesbeth; van Schayck, Constant P.; Dompeling, Edward

    2016-01-01

    Background There is increasing evidence that obesity is related to asthma development and severity. However, it is largely unknown whether weight reduction can influence asthma management, especially in children. Objective To determine the effects of a multifactorial weight reduction intervention on asthma management in overweight/obese children with (a high risk of developing) asthma. Methods An 18-month weight-reduction randomized controlled trial was conducted in 87 children with overweight/obesity and asthma. Every six months, measurements of anthropometry, lung function, lifestyle parameters and inflammatory markers were assessed. Analyses were performed with linear mixed models for longitudinal analyses. Results After 18 months, the body mass index-standard deviation score decreased by -0.14±0.29 points (p<0.01) in the intervention group and -0.12±0.34 points (p<0.01) in the control group. This change over time did not differ between groups (p>0.05). Asthma features (including asthma control and asthma-related quality of life) and lung function indices (static and dynamic) improved significantly over time in both groups. The FVC% predicted improved over time by 10.1 ± 8.7% in the intervention group (p<0.001), which was significantly greater than the 6.1 ± 8.4% in the control group (p<0.05). Conclusions & clinical relevance Clinically relevant improvements in body weight, lung function and asthma features were found in both the intervention and control group, although some effects were more pronounced in the intervention group (FVC, asthma control, and quality of life). This implies that a weight reduction intervention could be clinically beneficial for children with asthma. Trial Registration ClinicalTrials.gov NCT00998413 PMID:27294869

  10. Peers Promoting Physical Activity among Breast Cancer Survivors: A Randomized Controlled Trial

    PubMed Central

    Pinto, Bernardine M.; Stein, Kevin; Dunsiger, Shira

    2015-01-01

    Objective Although studies have shown that physical activity (PA) can reduce some treatment-related side-effects of breast cancer, there is a need to offer PA programs outside of research settings to reach more cancer survivors. We partnered with the American Cancer Society's Reach to Recovery program (RTR) to train their volunteers (breast cancer survivors) to deliver a 12-week PA intervention to other breast cancer survivors. Methods We conducted a randomized controlled trial to compare the PA intervention delivered by RTR volunteers (PA plus RTR) with contact control (RTR Control). Eighteen RTR volunteers/coaches (mean age=54.9 years, mean years since diagnosis=7.0) delivered the contact control condition or the PA intervention. Seventy-six breast cancer survivors in New England (mean age=55.6 years, mean years since diagnosis=1.1) were randomized to one of the two groups. At baseline, 12 weeks (post-intervention) and at 24 weeks, participants wore an accelerometer for seven days, were interviewed about their PA and reported their motivational readiness for PA. Results Adjusted mixed effects longitudinal regression models showed significant group differences favoring the PA plus RTR group in minutes of moderate to vigorous PA at 12 weeks (mean difference=103 minutes/ week, p<.001) and 24 weeks (mean difference=34.7 minutes/week, p=.03). Results were corroborated with significant group differences in accelerometer data favoring the PA plus RTR group at both time-points. Conclusions Peer volunteers were able to significantly increase PA among cancer survivors relative to contact control. Partnerships with existing volunteer programs can help to widen the reach of behavioral interventions among cancer survivors. PMID:25110844

  11. Randomized Controlled Trial of BASICS for Heavy Drinking Mandated and Volunteer Undergraduates: 12-Month Outcomes

    PubMed Central

    Terlecki, Meredith A.; Buckner, Julia D.; Larimer, Mary E.; Copeland, Amy L.

    2014-01-01

    This is the first randomized trial testing whether heavy drinking undergraduates mandated to the Brief Alcohol Screening and Intervention for College Students (BASICS) program following a campus alcohol violation would benefit as much as heavy drinking volunteers up to one year post-intervention using control groups with high-risk drinkers to model disciplinary-related and naturalistic changes in drinking. Participants (61% male; 51% mandated; 84% Caucasian; Mage = 20.14 years) were screened for heavy drinking and randomized to BASICS (n = 115) or assessment-only control (n = 110). Outcome measures (drinking, alcohol problems) were collected at baseline, 4 weeks, 3, 6, and 12 months post-intervention. At 4 weeks post-intervention, intent-to-treat multilevel longitudinal models showed that regardless of referral group (mandated or volunteer) BASICS significantly decreased weekly drinking, typical drinks, and peak drinks relative to controls (ds = .41-.92). BASICS had a large effect on decreases in alcohol problems (d = .87). At 12 months post-intervention, BASICS participants (regardless of referral group) reported significantly fewer alcohol problems (d = .56) compared to controls. Significant long-term intervention gains for peak and typical drinks were sustained in both referral groups relative to controls (ds = .42; .11). Referral group had no significant main effect and did not interact with intervention condition to predict outcomes. Given that BASICS was associated with less drinking and fewer alcohol problems (even among heavier drinking mandated students up to one year post-intervention), provision of BASICS-style programs within disciplinary settings may help reduce heavy and problematic drinking among at-risk students. PMID:25844834

  12. Efficient Bayesian Joint Models for Group Randomized Trials with Multiple Observation Times and Multiple Outcomes

    PubMed Central

    Xu, Xinyi; Pennell, Michael L.; Lu, Bo; Murray, David M.

    2013-01-01

    Summary In this paper, we propose a Bayesian method for Group Randomized Trials (GRTs) with multiple observation times and multiple outcomes of different types. We jointly model these outcomes using latent multivariate normal linear regression, which allows treatment effects to change with time and accounts for 1.) intra-class correlation (ICC) within groups 2.) the correlation between different outcomes measured on the same subject and 3.) the over-time correlation (OTC) of each outcome. Moreover we develop a set of innovative priors for the variance components which yield direct inference on the correlations, avoid undesirable constraints, and allow utilization of information from previous studies. We illustrate through simulations that our model can improve estimation efficiency (lower posterior standard deviations) of ICCs and treatment effects relative to single outcome models and models with diffuse priors on the variance components. We also demonstrate the methodology using body composition data collected in the Trial of Activity in Adolescent Girls (TAAG). PMID:22733563

  13. 78 FR 36541 - Public Interface Control Working Group (ICWG) Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-18

    ... Department of the Air Force Public Interface Control Working Group (ICWG) Meeting ACTION: Public ICWG... be hosting a Public Interface Control Working Group (ICWG) meeting for the Navstar GPS public signals... Control System (OCX) to User Support Community Interfaces (ICD-GPS-870). Dates and times can be...

  14. Effects of Coriandrum sativum Syrup on Migraine: A Randomized, Triple-Blind, Placebo-Controlled Trial

    PubMed Central

    Delavar Kasmaei, Hosein; Ghorbanifar, Zahra; Zayeri, Farid; Minaei, Bagher; Kamali, Seyed Hamid; Rezaeizadeh, Hossein; Amin, Gholamreza; Ghobadi, Ali; Mirzaei, Zohreh

    2016-01-01

    Background: Migraine is one of the most common and debilitating neurological problems. Although numerous preventive drugs are used to treat migraine, their complications are unavoidable. Application of herbal medicine, especially well-known medicinal plants, to treatment of chronic diseases, like migraine, could be effective. Coriandrum sativum L. (C. sativum) fruit is one of the most commonly prescribed herbs in Persian medicine, which has been used to treat headache. Objectives: This study was designed to evaluate the effects of C. sativum syrup on duration, severity and frequency of migraine. Patients and Methods: A total of 68 migraineurs, who had the eligibility criteria, according to international headache society diagnostic criteria, were randomly assigned to intervention group (n = 34) or control group (n = 34). In addition to 500 mg of sodium valproate per day, in intervention group, they received 15 mL of Coriander fruit syrup and 15 mL of placebo syrup, in control group, three times a day, during a month. The subjects were followed for clinical efficacy at weeks 1, 2, 3 and 4. The number of migraine attacks per week, as well as the duration and severity of attacks, were evaluated. Results: Of 68 patients randomized, 66 were included in analysis. The generalized estimating equations analysis showed that the Coriander fruit syrup decreased duration, severity and frequency of migraine, in the intervention group (P < 0.001). To be more precise, the mean migraine duration, severity and frequency, in the intervention group, were 5.7 hours, 3.65 units and about 50% less than control group, respectively. Conclusions: Results of this study showed that C. sativum fruit is efficient in reduction of the duration and frequency of migraine attacks and in diminishing pain degree. PMID:26889386

  15. Antiadhesive effect and safety of oxidized regenerated cellulose after thyroidectomy: a prospective, randomized controlled study

    PubMed Central

    Park, Kyoung Sik; Lee, Kyu Eun; Ku, Do Hoon; Kim, Su-Jin; Park, Won Seo; Kim, Hoon Yub; Kwon, Mi Ra

    2013-01-01

    Purpose To evaluate the antiadhesive effects and safety of an oxidized regenerated cellulose (Interceed) after thyroidectomy. Methods Seventy-six thyroidectomized patients were prospectively randomized into two groups with regard to the use of Interceed. We evaluated each group for their adhesive symptoms using four subjective and four objective items at the 2nd week, 3rd and 6th month after thyroidectomy. All patients were examined for vocal cord motility by indirect laryngoscope at each period. Results Total adhesion scores at each postoperative follow-up period decreased with time, but were not significantly different in each group. The median score for swallowing discomfort for liquid was significantly lower in the Interceed group than in the control group 2 weeks after surgery. In addition, the severity of skin adhesion to the trachea was reduced in the Interceed group compared with the control group 6 months after surgery. During the study, there were no adverse effects or significant differences in postoperative complications between the groups. Conclusion Interceed appeared to be safe and effective in improving neck discomfort at early postoperative periods and preventing skin adhesion to the trachea 6 months after thyroidectomy. PMID:23741689

  16. New Beginnings for mothers and babies in prison: A cluster randomized controlled trial

    PubMed Central

    Sleed, Michelle; Baradon, Tessa; Fonagy, Peter

    2013-01-01

    Mothers in prison represent a high-risk parenting population. New Beginnings is an attachment-based group intervention designed specifically for mothers and babies in prison. This cluster randomized trial examined the outcomes for 88 mothers and babies participating in the New Beginnings program and 75 dyads residing in prisons where the intervention did not take place. Outcomes were measured in terms of parental reflective functioning, the quality of parent–infant interaction, maternal depression, and maternal representations. Mothers in the control group deteriorated in their level of reflective functioning and behavioral interaction with their babies over time, whereas the mothers in the intervention group did not. There were no significant group effects on levels of maternal depression or mothers' self-reported representations of their babies over time. An attachment-based intervention may mitigate some of the risks to the quality of the parent–infant relationship for these dyads. PMID:23550526

  17. Diabetes Self-Management Smartphone Application for Adults With Type 1 Diabetes: Randomized Controlled Trial

    PubMed Central

    Vandelanotte, Corneel; Fenning, Andrew; Duncan, Mitch J

    2013-01-01

    Background Persistently poor glycemic control in adult type 1 diabetes patients is a common, complex, and serious problem initiating significant damage to the cardiovascular, renal, neural, and visual systems. Currently, there is a plethora of low-cost and free diabetes self-management smartphone applications available in online stores. Objective The aim of this study was to examine the effectiveness of a freely available smartphone application combined with text-message feedback from a certified diabetes educator to improve glycemic control and other diabetes-related outcomes in adult patients with type 1 diabetes in a two-group randomized controlled trial. Methods Patients were recruited through an online type 1 diabetes support group and letters mailed to adults with type 1 diabetes throughout Australia. In a 6-month intervention, followed by a three-month follow-up, patients (n=72) were randomized to usual care (control group) or usual care and the use of a smartphone application (Glucose Buddy) with weekly text-message feedback from a Certified Diabetes Educator (intervention group). All outcome measures were collected at baseline and every three months over the study period. Patients’ glycosylated hemoglobin levels (HbA1c) were measured with a blood test and diabetes-related self-efficacy, self-care activities, and quality of life were measured with online questionnaires. Results The mean age of patients was 35.20 years (SD 10.43) (28 male, 44 female), 39% (28/72) were male, and patients had been diagnosed with type 1 diabetes for a mean of 18.94 years (SD 9.66). Of the initial 72 patients, 53 completed the study (25 intervention, 28 control group). The intervention group significantly improved glycemic control (HbA1c) from baseline (mean 9.08%, SD 1.18) to 9-month follow-up (mean 7.80%, SD 0.75), compared to the control group (baseline: mean 8.47%, SD 0.86, follow-up: mean 8.58%, SD 1.16). No significant change over time was found in either group in

  18. Cyclical iron supplementation to reduce anemia among Brazilian preschoolers: a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Iron-deficiency anemia is the most common type of nutritional disorder. New strategies for the treatment of anemia are very important for its reduction. The aim of this study was to assess the efficacy and feasibility of cyclical iron supplementation as a strategy to reduce the prevalence of anemia among preschoolers. Methods A randomized controlled trial was performed in the entire population of under five-year-old children who attended government daycare centers in a small town in the State of Sao Paulo, Brazil. The children were randomly allocated into two intervention groups: the Weekly and Cyclical Groups. During a ten-month period, the Weekly Group (n = 51) received weekly doses of 30 mg elemental iron (40 doses) and the Cyclical Group (n = 48) received two cycles of 20 daily doses of 30 mg elemental iron separated by a four-month period (40 doses). Results Overall, at the end of ten months, the prevalence of anemia of the children on both supplementation regimens showed a significant decrease from 20.20% to 5.05% (p-value < 0.0005). There was no significant difference in the anemia between the two groups (p-value = 0.35). The mean hemoglobin concentration increased by 0.27 g/dL (p-value < 0.016) and 0.47 g/dL (p-value < 0.0005) in the Weekly and Cyclical Groups, respectively; again there was no significant difference between groups (p-value = 0.17). However, the cyclical regimen was easier to manage. Conclusions Both supplementation regimens significantly reduced the prevalence of anemia however administration of the Cyclical Group was easier to carry out and control. Clinical trial registration number NCT00992823 PMID:23305566

  19. Comparative Efficacy of Oil Pulling and Chlorhexidine on Oral Malodor: A Randomized Controlled Trial

    PubMed Central

    Devi M, Aruna; Narang, Ridhi; V, Swathi; Makkar, Diljot Kaur

    2014-01-01

    Background: Oral malodor affects a large section of population. Traditional Indian folk remedy, oil pulling not only reduces it but can also bring down the cost of treatment. Aims: To compare the efficacy of oil pulling and chlorhexidine in reducing oral malodor and microbes. Materials and Methods: Three week randomized controlled trial was conducted among 60 students of three hostels of Maharani College of science and arts and commerce and Smt V.H.D.College of Home Science. The hostels were randomized into two intervention groups namely chlorhexidine group, sesame oil and one control (placebo) group. Twenty girls were selected from each hostel based on inclusion and exclusion criteria. Informed consent was obtained. The parameters recorded at the baseline (day 0) and post intervention on day 22 were plaque index (PI), gingival index (GI), objective (ORG1) and subjective (ORG2) organoleptic scores and anaerobic bacterial colony (ABC) count. Intra and inter group comparisons were made using Kruskal Wallis test, Wilcoxan sign rank test, ANOVA and student t-test. Results: There was significant reduction (p<0.05) in the mean scores of all the parameters within sesame oil and chlorhexidine group. Among the groups significant difference was observed in objective and subjective organoleptic scores. Post hoc test showed significant difference (p<0.000) in mean organoleptic scores of sesame oil and placebo and chlorhexidine and placebo group. No significant difference (p<0.05) was observed between sesame oil and chlorhexidine group. Conclusion: Oil pulling with sesame oil is equally efficacious as chlorhexidine in reducing oral malodor and microbes causing it. It should be promoted as a preventive home care therapy. PMID:25584309

  20. 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

  1. The "Healthy Habits, Healthy Girls" randomized controlled trial for girls: study design, protocol, and baseline results.

    PubMed

    Leme, Ana Carolina Barco; Philippi, Sonia Tucunduva

    2015-07-01

    The purpose of this article is to describe the study design, protocol, and baseline results of the "Healthy Habits, Healthy Girls" program. The intervention is being evaluated through a randomized controlled trial in 10 public schools in the city of São Paulo, Brazil. Data on the following variables were collected and assessed at baseline and will be reevaluated at 7 and 12 months: body mass index, waist circumference, dietary intake, nutrition, physical activity, social cognitive mediators, physical activity level, sedentary behaviors, self-rated physical status, and overall self-esteem. According to the baseline results, 32.4% and 23.4% of girls were overweight in the intervention and control groups, respectively, and in both groups a higher percentage failed to meet daily recommendations for moderate and vigorous physical activity and maximum screen time (TV, computer, mobile devices). There were no significant differences between the groups for most of the variables, except age (p = 0.000) and waist circumference (p = 0.014). The study showed a gap in the Brazilian literature on protocols for randomized controlled trials to prevent obesity among youth. The current study may thus be an important initial contribution to the field. PMID:26248094

  2. Effect of Intravenous Iron Supplementation on Acute Mountain Sickness: A Preliminary Randomized Controlled Study

    PubMed Central

    Ren, Xuewen; Zhang, Qiuying; Wang, Hao; Man, Chunyan; Hong, Heng; Chen, Li; Li, Tanshi; Ye, Ping

    2015-01-01

    Background The aim of this study was to assess the role of intravenous iron supplementation in the prevention of AMS. Material/Methods This was a randomized, double-blinded, placebo-controlled study. Forty-one (n=41) healthy Chinese low-altitude inhabitants living in Beijing, China (altitude of about 50 meters) were randomly assigned into intravenous iron supplementation (ISS group; n=21) and placebo (CON group; n=20) groups. Participants in the ISS group received iron sucrose supplement (200 mg) before flying to Lhasa, China (altitude of 4300 meters). Acute mountain sickness (AMS) severity was assessed with the Lake Louise scoring (LLS) system within 5 days after landing on the plateau (at high altitude). Routine check-ups, clinical biochemistry, and blood tests were performed before departure and 24 h after arrival. Results A total of 38 participants completed the study (ISS group: n=19; CON group: n=19). The rate of subjects with AMS (LLS>3) was lower in the ISS group compared with the CON group, but no significant differences were obtained (P>0.05). There were no differences in patients’ baseline characteristics. The physiological indices were similar in both groups except for serum iron concentrations (19.44±10.02 vs. 85.10±26.78 μmol/L) and transferrin saturation rates (28.20±12.14 vs. 68.34±33.12%), which were significantly higher in the ISS group (P<0.05). Finally, heart rate was identified as a contributing factor of LLS. Conclusions These preliminary findings suggest that intravenous iron supplementation has no significant protective effect on AMS in healthy Chinese low-altitude inhabitants. PMID:26175087

  3. The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    PubMed

    Cramer, Holger; Ward, Lesley; Saper, Robert; Fishbein, Daniel; Dobos, Gustav; Lauche, Romy

    2015-08-15

    As yoga has gained popularity as a therapeutic intervention, its safety has been questioned in the lay press. Thus, this review aimed to systematically assess and meta-analyze the frequency of adverse events in randomized controlled trials of yoga. MEDLINE/PubMed, Scopus, the Cochrane Library, and IndMED were screened through February 2014. Of 301 identified randomized controlled trials of yoga, 94 (1975-2014; total of 8,430 participants) reported on adverse events. Life-threatening, disabling adverse events or those requiring intensive treatment were defined as serious and all other events as nonserious. No differences in the frequency of intervention-related, nonserious, or serious adverse events and of dropouts due to adverse events were found when comparing yoga with usual care or exercise. Compared with psychological or educational interventions (e.g., health education), more intervention-related adverse events (odds ratio = 4.21, 95% confidence interval: 1.01, 17.67; P = 0.05) and more nonserious adverse events (odds ratio = 7.30, 95% confidence interval: 1.91, 27.92; P < 0.01) occurred in the yoga group; serious adverse events and dropouts due to adverse events were comparable between groups. Findings from this review indicate that yoga appears as safe as usual care and exercise. The adequate reporting of safety data in future randomized trials of yoga is crucial to conclusively judge its safety. PMID:26116216

  4. Effects of oral vitamin E on treatment of atopic dermatitis: A randomized controlled trial

    PubMed Central

    Jaffary, Fariba; Faghihi, Gita; Mokhtarian, Arghavan; Hosseini, Sayed Mohsen

    2015-01-01

    Background: The pathogenesis of atopic dermatitis (AD) remains to be determined; recently a possible change in the immune system with production of immunoglobulins is proposed. As vitamin E is a potent antioxidant, with the ability to decrease the serum levels of immunoglobulin E (IgE) in atopic patients, we aimed to evaluate the effect of oral vitamin E on treatment of AD. Materials and Methods: This randomized, double-blind, placebo-controlled trial comprised seventy participants with mild-to-moderate AD, based on the Hanifin and Rajka diagnostic criteria. The patients were randomly selected from teaching skin clinics in Isfahan, Iran. They were randomly assigned to two groups of equal number, receiving vitamin E (400 IU/day) and placebo for four 4 months. Each month, the extent, severity, and subjective symptoms including itch and sleeplessness were measured by SCORAD index. Three months after the end of intervention, the recurrence rate was assessed. Results: The improvement in all symptoms, except sleeplessness, was significantly higher in the group receiving vitamin E than in controls (–1.5 vs. 0.218 in itching, –10.85 vs. –3.54 in extent of lesion, and –11.12 vs. –3.89 in SCORAD index, respectively, P < 0.05). Three months after the end of intervention, the recurrence rate of AD was evaluated. Recurrence rate between all 42 individuals, who remained in the study, was 18.6%. Recurrence ratio of the group receiving vitamin E compared to the placebo group was 1.17, without significant differences between the two groups (P > 0.05). Conclusion: This study suggests that vitamin E can improve the symptoms and the quality of life in patients with AD. As vitamin E has no side effects with a dosage of 400 IU/day, it can be recommended for the treatment of AD. PMID:26941808

  5. A randomized control study of instructional approaches for struggling adult readers

    PubMed Central

    Greenberg, Daphne; Wise, Justin; Morris, Robin; Fredrick, Laura; Nanda, Alice O.; Pae, Hye-K.

    2011-01-01

    This study measured the effectiveness of various instructional approaches on the reading outcomes of 198 adults who read single words at the 3.0 through 5.9 grade equivalency levels. The students were randomly assigned to one of the following interventions: Decoding and Fluency; Decoding, Comprehension, and Fluency; Decoding, Comprehension, Fluency, and Extensive Reading; Extensive Reading; and a Control/Comparison approach. The Control/Comparison approach employed a curriculum common to community-based adult literacy programs, and the Extensive Reading approach focused on wide exposure to literature. The Fluency component was a guided repeated oral reading approach, and the Decoding/Comprehension components were SRA/McGraw-Hill Direct Instruction Corrective Reading Programs. Results indicated continued weaknesses in and poor integration of participants’ skills. Although students made significant gains independent of reading instruction group, all improvements were associated with small effect sizes. When reading instruction group was considered, only one significant finding was detected, with the Comparison/Control group, the Decoding and Fluency group, and the Decoding, Comprehension, Extensive Reading and Fluency group showing stronger word attack outcomes than the Extensive Reading group. PMID:22180789

  6. Effect of Vimala Massage on Physiological Jaundice in Infants: A Randomized Controlled Trial

    PubMed Central

    Seyyedrasooli, Alehe; Valizadeh, Leila; Hosseini, Mohammad Bager; Asgari Jafarabadi, Mohammad; Mohammadzad, Masoome

    2014-01-01

    Introduction: Considering the prevalence of Jaundice in newborn infants and the risk of developing acute Bilirubin encephalopathy, in early weeks after birth. the importance of Infancy, as well as positive effects of giving massage on physical and behavioral growth and evolution of infants, the current study has been aimed to investigate the effects of Vimala massage on neonatal physiological Jaundice. Methods: This is a single blind clinical trial study, 43 healthy term infants, with 1st day Bilirubin levels of less than 5mg/dl, carried out in Tabriz Al-Zahra hospital. Newborns were selected through convenience sampling and then randomly assigned to intervention and control groups. Control group received routine care, while newborns of intervention group received four days of Vimala massage starting from the first day of their birth. Main variables of study include transcutaneous Bilirubin and frequency of defecation. Collected data were analyzed by SPSS Ver.13 through Chi-square and Mann-Whitney tests. Results: There were no statistical significant differences between two groups for skin bilirubin, however the number of defecations in the intervention group exceeded than of control group, and was statistically significant. Conclusion: The Results show that Vimala massage within four days has no effect on increasing process of bilirubin, yet can affect the incidence rate of physiological Jaundice and care of infants by increasing defecation frequency. PMID:25276760

  7. Rural providers' access to online resources: a randomized controlled trial

    PubMed Central

    Hall, Laura J.; McElfresh, Karen R.; Warner, Teddy D.; Stromberg, Tiffany L.; Trost, Jaren; Jelinek, Devin A.

    2016-01-01

    Objective The research determined the usage and satisfaction levels with one of two point-of-care (PoC) resources among health care providers in a rural state. Methods In this randomized controlled trial, twenty-eight health care providers in rural areas were stratified by occupation and region, then randomized into either the DynaMed or the AccessMedicine study arm. Study participants were physicians, physician assistants, and nurses. A pre- and post-study survey measured participants' attitudes toward different information resources and their information-seeking activities. Medical student investigators provided training and technical support for participants. Data analyses consisted of analysis of variance (ANOVA), paired t tests, and Cohen's d statistic to compare pre- and post-study effects sizes. Results Participants in both the DynaMed and the AccessMedicine arms of the study reported increased satisfaction with their respective PoC resource, as expected. Participants in both arms also reported that they saved time in finding needed information. At baseline, both arms reported too little information available, which increased to “about right amounts of information” at the completion of the study. DynaMed users reported a Cohen's d increase of +1.50 compared to AccessMedicine users' reported use of 0.82. DynaMed users reported d2 satisfaction increases of 9.48 versus AccessMedicine satisfaction increases of 0.59 using a Cohen's d. Conclusion Participants in the DynaMed arm of the study used this clinically oriented PoC more heavily than the users of the textbook-based AccessMedicine. In terms of user satisfaction, DynaMed users reported higher levels of satisfaction than the users of AccessMedicine. PMID:26807050

  8. Sham Acupressure Controls Used in Randomized Controlled Trials: A Systematic Review and Critique

    PubMed Central

    Tan, Jing-Yu; Suen, Lorna K. P.; Wang, Tao; Molassiotis, Alexander

    2015-01-01

    Objectives To explore the commonly utilized sham acupressure procedures in existing acupressure trials, and to assess whether different types of sham interventions yield different therapeutic outcomes, and, as far as possible, to identify directions for the future development of an adequate sham acupressure method. Methods Randomized controlled trials comparing true acupressure with sham interventions were included. Thirteen electronic databases were adopted to locate relevant studies from inception to July 3, 2014. Meanwhile, eight Chinese journals on complementary and alternative medicine were manually searched to locate eligible articles. In addition, eligible studies listed in the reference lists of the included papers and other related systematic reviews on acupressure were also screened to further search any potentially eligible trials. Methodological quality of the included studies was evaluated using the risk of bias assessment tool developed by the Cochrane Back Review Group. Descriptive analysis was adopted to summarize the therapeutic outcomes. Results Sixty-six studies with 7265 participants were included. Methodological quality of the included trials was generally satisfactory. Six types of sham acupressure approaches were identified and “non-acupoint” stimulation was the most frequently utilized sham point while an acupressure device was the most commonly used approach for administering sham treatments. Acupressure therapy was a beneficial approach in managing a variety of health problems and the therapeutic effect was found to be more effective in the true acupressure groups than that in the sham comparative groups. No clear association could be identified between different sham acupressure modalities and the reported treatment outcomes. Conclusions A great diversity of sham acupressure controls have been used in clinical practice and research. A solid conclusion whether different sham alternatives are related to different treatment outcomes

  9. The Japan Statin Treatment Against Recurrent Stroke (J-STARS): A Multicenter, Randomized, Open-label, Parallel-group Study

    PubMed Central

    Hosomi, Naohisa; Nagai, Yoji; Kohriyama, Tatsuo; Ohtsuki, Toshiho; Aoki, Shiro; Nezu, Tomohisa; Maruyama, Hirofumi; Sunami, Norio; Yokota, Chiaki; Kitagawa, Kazuo; Terayama, Yasuo; Takagi, Makoto; Ibayashi, Setsuro; Nakamura, Masakazu; Origasa, Hideki; Fukushima, Masanori; Mori, Etsuro; Minematsu, Kazuo; Uchiyama, Shinichiro; Shinohara, Yukito; Yamaguchi, Takenori; Matsumoto, Masayasu

    2015-01-01

    Background Although statin therapy is beneficial for the prevention of initial stroke, the benefit for recurrent stroke and its subtypes remains to be determined in Asian, in whom stroke profiles are different from Caucasian. This study examined whether treatment with low-dose pravastatin prevents stroke recurrence in ischemic stroke patients. Methods This is a multicenter, randomized, open-label, blinded-endpoint, parallel-group study of patients who experienced non-cardioembolic ischemic stroke. All patients had a total cholesterol level between 4.65 and 6.21 mmol/L at enrollment, without the use of statins. The pravastatin group patients received 10 mg of pravastatin/day; the control group patients received no statins. The primary endpoint was the occurrence of stroke and transient ischemic attack (TIA), with the onset of each stroke subtype set to be one of the secondary endpoints. Finding Although 3000 patients were targeted, 1578 patients (491 female, age 66.2 years) were recruited and randomly assigned to pravastatin group or control group. During the follow-up of 4.9 ± 1.4 years, although total stroke and TIA similarly occurred in both groups (2.56 vs. 2.65%/year), onset of atherothrombotic infarction was less frequent in pravastatin group (0.21 vs. 0.64%/year, p = 0.0047, adjusted hazard ratio 0.33 [95%CI 0.15 to 0.74]). No significant intergroup difference was found for the onset of other stroke subtypes, and for the occurrence of adverse events. Interpretation Although whether low-dose pravastatin prevents recurrence of total stroke or TIA still needs to be examined in Asian, this study has generated a hypothesis that it may reduce occurrence of stroke due to larger artery atherosclerosis. Funding This study was initially supported by a grant from the Ministry of Health, Labour and Welfare, Japan. After the governmental support expired, it was conducted in collaboration between Hiroshima University and the Foundation for Biomedical Research and

  10. Human promoter genomic composition demonstrates non-random groupings that reflect general cellular function

    PubMed Central

    McNutt, Markey C; Tongbai, Ron; Cui, Wenwu; Collins, Irene; Freebern, Wendy J; Montano, Idalia; Haggerty, Cynthia M; Chandramouli, GVR; Gardner, Kevin

    2005-01-01

    Background The purpose of this study is to determine whether or not there exists nonrandom grouping of cis-regulatory elements within gene promoters that can be perceived independent of gene expression data and whether or not there is any correlation between this grouping and the biological function of the gene. Results Using ProSpector, a web-based promoter search and annotation tool, we have applied an unbiased approach to analyze the transcription factor binding site frequencies of 1400 base pair genomic segments positioned at 1200 base pairs upstream and 200 base pairs downstream of the transcriptional start site of 7298 commonly studied human genes. Partitional clustering of the transcription factor binding site composition within these promoter segments reveals a small number of gene groups that are selectively enriched for gene ontology terms consistent with distinct aspects of cellular function. Significance ranking of the class-determining transcription factor binding sites within these clusters show substantial overlap between the gene ontology terms of the transcriptions factors associated with the binding sites and the gene ontology terms of the regulated genes within each group. Conclusion Thus, gene sorting by promoter composition alone produces partitions in which the "regulated" and the "regulators" cosegregate into similar functional classes. These findings demonstrate that the transcription factor binding site composition is non-randomly distributed between gene promoters in a manner that reflects and partially defines general gene class function. PMID:16232321

  11. Context-free pairs of groups II — Cuts, tree sets, and random walks

    PubMed Central

    Woess, Wolfgang

    2012-01-01

    This is a continuation of the study, begun by Ceccherini-Silberstein and Woess (2009) [5], of context-free pairs of groups and the related context-free graphs in the sense of Muller and Schupp (1985) [22]. The graphs under consideration are Schreier graphs of a subgroup of some finitely generated group, and context-freeness relates to a tree-like structure of those graphs. Instead of the cones of Muller and Schupp (1985) [22] (connected components resulting from deletion of finite balls with respect to the graph metric), a more general approach to context-free graphs is proposed via tree sets consisting of cuts of the graph, and associated structure trees. The existence of tree sets with certain “good” properties is studied. With a tree set, a natural context-free grammar is associated. These investigations of the structure of context free pairs, resp. graphs are then applied to study random walk asymptotics via complex analysis. In particular, a complete proof of the local limit theorem for return probabilities on any virtually free group is given, as well as on Schreier graphs of a finitely generated subgoup of a free group. This extends, respectively completes, the significant work of Lalley (1993, 2001) [18,20]. PMID:22267873

  12. Effectiveness of a web-based intervention for injured claimants: a randomized controlled trial

    PubMed Central

    2013-01-01

    Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process. One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the claimant. The aim of this study was to empower injured claimants in order to facilitate recovery. Methods Participants were recruited by three Dutch claims settlement offices. The participants had all been injured in a traffic crash and were involved in a compensation process. The study design was a randomized controlled trial. An intervention website was developed with (1) information about the compensation process, and (2) an evidence-based, therapist-assisted problem-solving course. The control website contained a few links to already existing websites. Outcome measures were empowerment, self-efficacy, health status (including depression, anxiety, and somatic symptoms), perceived fairness, ability to work, claims knowledge and extent of burden. The outcomes were self-reported through online questionnaires and were measured four times: at baseline, and at 3, 6, and 12 months. Results In total, 176 participants completed the baseline questionnaire after which they were randomized into either the intervention group (n = 88) or the control group (n = 88). During the study, 35 participants (20%) dropped out. The intervention website was used by 55 participants (63%). The health outcomes of the intervention group were no different to those of the control group. However, the intervention group considered the received compensation to be fairer (P <0.01). The subgroup analysis of intervention users versus nonusers did not reveal significant results. The intervention website was evaluated positively. Conclusions Although the web-based intervention was not used enough to improve the health of injured

  13. Efficacy of Bosentan in patients after Fontan procedures: a double-blind, randomized controlled trial.

    PubMed

    Shang, Xiao-Ke; Lu, Rong; Zhang, Xi; Zhang, Chang-Dong; Xiao, Shu-Na; Liu, Mei; Wang, Bin; Dong, Nian-Guo

    2016-08-01

    Fontan surgery is a widely used palliative procedure that significantly improves the survival period of patients with complex congenital heart disease (CHD). However, it does not decrease postoperative complication rate. Previous studies suggested that elevated mean pulmonary artery pressure (mPAP) and vascular resistance lead to decreased exercise tolerance and myocardial dysfunction. Therapy with endothelial receptor antagonists (Bosentan) has been demonstrated to improve the patients' prognosis. A double-blind, randomized controlled trial was performed to explore the efficacy of Bosentan in treating patients who underwent the Fontan procedure. Eligible participants were randomly divided into Bosentan group and control group. Liver function was tested at a local hospital and the results were reported to the phone inspector every month. If the results suggested abnormal liver function, treatment would be adjusted or terminated. All the participants finished the follow-up study, with no patients lost to follow-up. Unblinding after 2-year follow-up, no mortality was observed in either group. However, secondary end-points were found to be significantly different in the comparable groups. The cardiac function and 6-min walking distance in the Bosentan group were significantly superior to those in the control group (P=0.018 and P=0.027). Bosentan could improve New York Heart Association (NYHA) functional status and improve the results of the 6-min walking test (6MWT) in Fontan patients post-surgery, and no other benefits were observed. Furthermore, a primary meta-analysis study systematically reviewed all the similar clinical trails worldwide and concluded an overall NYHA class improvement in Fontan patients who received Bosentan treatments. PMID:27465329

  14. Probiotic for irritable bowel syndrome in pediatric patients: a randomized controlled clinical trial

    PubMed Central

    Kianifar, Hamidreza; Jafari, Seyed Ali; Kiani, Mohammadali; Ahanchian, Hamid; Ghasemi, Seyed Vahid; Grover, Zubin; Mahmoodi, Leili Zarif; Bagherian, Rita; Khalesi, Maryam

    2015-01-01

    Background: Irritable bowel syndrome (IBS) is a common gastrointestinal disorder in children. Recently, probiotics have been suggested as a treatment option for gastrointestinal disorders. The most effective species and the most appropriate doses are still unknown. Objective: The aim of this study was to assess the effects of Lactobacillus GG (LGG) for treating IBS in pediatric patients. Methods: In a controlled, double blind, randomized trial, patients with IBS diagnosed by Rome III criteria from August 2012 to September 2012 at Dr. Sheikh Hospital, Mashhad University of Medical Sciences, Iran, were assigned to one of two groups, i.e., intervention and control groups. For four weeks, the intervention group received a probiotic in capsule form that contained LGG at a concentration of 1×1010 cfu/ml bacteria. For the same period, the control group received a placebo capsule that had the same shape and color but only contained inulin, which also was present in the LGG capsules. The primary outcome was any change in the severity of the patients’ pain, and we used a five-point Likert scale to evaluate the severity of their pain. Secondary outcomes were ghanges of the functional scale, stool patterns, and associated problems. Results: Fifty-two patients participated in the study, and 26 patients were assigned randomly to each of the two groups. The severity of the patients’ pain decreased significantly in the intervention group after one, two, three, and four weeks of treatment, as indicated by P-values of 0.01, 0.00, 0.00, and 0.00, respectively. Also, there was significant improvement in the functional scale after two weeks of treatment (P-value ≤ 0.00). Conclusion: Lactobacillus GG at a concentration of 1×1010 cfu/ml for a period of four weeks can lessen the severity of the patients’ pain and improve the functional scale in patients with irritable bowel syndrome. Probiotics can have therapeutic effects for IBS patients. PMID:26435825

  15. Insulation workers in Belfast. 1. Comparison of a random sample with a control population1

    PubMed Central

    Wallace, William F. M.; Langlands, Jean H. M.

    1971-01-01

    Wallace, W. F. M., and Langlands, J. H. M. (1971).Brit. J. industr. Med.,28, 211-216. Insulation workers in Belfast. 1. Comparison of a random sample with a control population. A sample of 50 men was chosen at random from the population of asbestos insulators in Belfast and matched with a control series of men of similar occupational group with respect to age, height, and smoking habit. Significantly more of the insulators complained of cough and sputum and had basal rales on examination. Clubbing was assessed by means of measurements of the hyponychial angle of both index fingers. These angles were significantly greater in the group of insulators. Twenty-one insulators had ϰ-rays which showed pleural calcification with or without pulmonary fibrosis; one control ϰ-ray showed pulmonary fibrosis. The insulators had no evidence of airways obstruction but static lung volume was reduced and their arterial oxygen tension was lower than that of the controls and their alveolar-arterial oxygen gradient was greater. PMID:5557841

  16. Computer decision support software safely improves glycemic control in the burn intensive care unit: a randomized controlled clinical study

    PubMed Central

    Mann, Elizabeth A.; Jones, John A.; Wolf, Steven E.; Wade, Charles E.

    2011-01-01

    Objective The optimal method for glycemic control in the critically burned patient is unknown. The purpose of this randomized controlled study was to determine the safety and efficacy of computer decision support software (CDSS) to control serum glucose concentration in a burn intensive care unit. Methods Eighteen adult burn/trauma patients receiving continuous insulin infusion were initially randomized to receive glucose management via a traditional paper-based protocol (PP) or a computer protocol (CP) for 72 hours, then crossed over to the alternate method for an additional 72 hours. Results Time in target glucose range (80-110 mg/dl) was higher in the CP group (47 ± 17% versus 41 ± 16.6%; p ≤ 0.05); time over target range was not significantly reduced in the CP group (49 ± 17.8% versus 54 ± 17.1; p = 0.08); and no difference was noted in time under target range of 80 mg/dl (CP 4.5 ± 2.8, PP 4.8 ± 3.3%; p = 0.8), under 60 mg/dl (p = 0.7), and under 40 mg/dl (p = 1.0). Severe hypoglycemic events (< 40 mg/dl) did not differ from the CP group compared to historical controls for patients receiving no insulin (p = 0.6). More glucose measurements were performed in the CP group (p = 0.0003), and nursing staff compliance with CP recommendations was greater (p < 0.0001). Conclusions Glycemic control using CDSS is safe and effective for the critically burned patient. Time in target range improved without increase in hypoglycemic events. CDSS enhanced consistency in practice, providing standardization among nursing staff. PMID:21240001

  17. Prophylactic effect of artemether on human schistosomiasis mansoni among Egyptian children: A randomized controlled trial.

    PubMed

    Elmorshedy, Hala; Tanner, Marcel; Bergquist, Robert N; Sharaf, Soraya; Barakat, Rashida

    2016-06-01

    A double-blind, randomized controlled trial was conducted in an endemic focus for Schistosoma mansoni in Kafr El-Sheikh Governorate, Northern Nile Delta, Egypt, to evaluate the prophylactic effect of artemether (ART) given in conjunction with praziquantel (PZQ). The study encompassed 913 primary school children randomly assigned to two treatment groups PZQ/ART and PZQ/ART-placebo. At baseline, both groups received 40 mg/kg body weight of PZQ twice four weeks apart, after which one group received 6 mg/kg body weight of ART every 3 weeks in 5 cycles during the transmission season and the other group received ART-placebo. At the end of the study, prevalence of infection among the PZQ/ART was approximately half that of the PZQ/ART-placebo group, i.e. 6.7% versus 11.6%, and incidence of new infections for the PZQ/ART was 2.7% versus 6.5% for the PZQ/ART-placebo. In conclusion, PZQ/ART combined therapy might be considered as an adjunct measure against human schistosomiasis, by specifically reducing transmission and therefore contribute to disease elimination. PMID:26921676

  18. A randomized controlled trial of trypsin to treat brown recluse spider bites in Guinea pigs.

    PubMed

    Cabaniss, Wyman W; Bush, Sean; O'Rourke, Dorcas P; Fletcher, Paul F; Brewer, Kori L; Lertpiriyapong, Kvin; Punja, Mohan; Miller, Susan N; Meggs, William J

    2014-09-01

    Brown recluse spider bites result in necrotic skin lesions for which there is no known antidote. Since venom toxins are proteins, a proteolytic enzyme like trypsin might be effective in reducing toxicity. The aim of this study was to conduct a randomized controlled trial of trypsin to treat brown recluse spider bites in guinea pigs. Subjects were 18 female guinea pigs. Anesthesia for injections was inhaled isoflurane. Analgesia was 0.05 mg/kg of buprenorphine twice a day as needed. Intervention was intradermal injection of 30 μg of brown recluse venom (Spider Pharm, Yarnell, AZ). Immediately after envenomation, subjects were randomized to two groups of nine: trypsin 10 μg in 1 mL normal saline and 1 mL of normal saline. The primary outcome was lesion area over a 10-day time period. Statistical analysis was performed with repeated measures ANOVA. Mean lesion area was smaller but not statistically different in the placebo group. Maximum lesion size occurred at day 4 in both groups, when lesion area was 76.1 ± 108.2 mm(2) in the placebo group and 149.7 ± 127.3 mm(2) in the treatment group. P value was 0.15 for placebo vs. treatment. This study did not establish a role for trypsin as a treatment for brown recluse spider bites in a guinea pig model. PMID:24849803

  19. An 8-week stress management program in pathological gamblers: a pilot randomized controlled trial.

    PubMed

    Linardatou, C; Parios, A; Varvogli, L; Chrousos, G; Darviri, C

    2014-09-01

    Stress plays a major role at the onset and relapse of pathological gambling (PG), but at the same time it can also be the aftermath of gambling behavior, thus revealing a reciprocal relationship. Although the role of stress has been well-documented, there is a paucity of studies investigating the effect of an adjunctive stress management program on PG. In this 8-week parallel randomized waitlist controlled trial pathological gamblers, already in the gamblers anonymous (GA) group, were assigned randomly in two groups, with the intervention group (n = 22) receiving an additional stress management program (consisting of education on diet and exercise, stress coping methods, relaxation breathing -RB- and progressive muscle relaxation -PMR). Self-reported measures were used in order to evaluate stress, depression, anxiety, sleep quality/disturbances, life-satisfaction and daily routine. The statistical analyses for the between group differences concerning the main psychosocial study outcomes revealed a statistically significant amelioration of stress, depression, anxiety symptoms and an increase of life-satisfaction and a better daily routine in participants of the intervention group. We hope that these will encourage researchers and clinicians to adopt stress management in their future work. PMID:24912736

  20. Psychological Intervention for Improving Cognitive Function in Cancer Survivors: A Literature Review and Randomized Controlled Trial

    PubMed Central

    King, Summer; Green, Heather Joy

    2015-01-01

    Although the impact of cancer and associated treatments on cognitive functioning is becoming an increasingly recognized problem, there are few published studies that have investigated psychological interventions to address this issue. A waitlist randomized controlled trial methodology was used to assess the efficacy of a group cognitive rehabilitation intervention (“ReCog”) that successfully targeted cancer-related cognitive decline in previously published pilot research. Participants were 29 cancer survivors who were randomly allocated to either the intervention group or a waitlist group who received the intervention at a later date, and 16 demographically matched community volunteers with no history of cancer (trial registration ACTRN12615000009516, available at http://www.ANZCTR.org.au/ACTRN12615000009516.aspx). The study was the first to include an adapted version of the Traumatic Brain Injury Self-Efficacy Scale to assess cognitive self-efficacy (CSE) in people who have experienced cancer. Results revealed participating in the intervention was associated with significantly faster performance on one objective cognitive task that measures processing speed and visual scanning. Significantly larger improvements for the intervention group were also found on measures of perceived cognitive impairments and CSE. There was some evidence to support the roles of CSE and illness perceptions as potential mechanisms of change for the intervention. Overall, the study provided additional evidence of feasibility and efficacy of group psychological intervention for targeting cancer-related cognitive decline. PMID:25859431

  1. Continuous quality improvement (CQI) in addiction treatment settings: design and intervention protocol of a group randomized pilot study

    PubMed Central

    2014-01-01

    Background Few studies have designed and tested the use of continuous quality improvement approaches in community based substance use treatment settings. Little is known about the feasibility, costs, efficacy, and sustainment of such approaches in these settings. Methods/Design A group-randomized trial using a modified stepped wedge design is being used. In the first phase of the study, eight programs, stratified by modality (residential, outpatient) are being randomly assigned to the intervention or control condition. In the second phase, the initially assigned control programs are receiving the intervention to gain additional information about feasibility while sustainment is being studied among the programs initially assigned to the intervention. Discussion By using this design in a pilot study, we help inform the field about the feasibility, costs, efficacy and sustainment of the intervention. Determining information at the pilot stage about costs and sustainment provides value for designing future studies and implementation strategies with the goal to reduce the time between intervention development and translation to real world practice settings. PMID:24467770

  2. Implant-supported mandibular overdentures in very old adults: a randomized controlled trial.

    PubMed

    Müller, F; Duvernay, E; Loup, A; Vazquez, L; Herrmann, F R; Schimmel, M

    2013-12-01

    The purpose of this study was (1) to investigate denture satisfaction following the conversion of existing mandibular complete dentures to implant overdentures (IOD) in very old edentulous patients who depend on help for activities of daily living and (2) to evaluate secondary end points, such as functional, structural, nutritional, and patient-centered aspects. For this randomized clinical trial, 2 interforaminal short implants were placed in the intervention group (n = 16, 85.0 ± 6.19 yrs) to retain mandibular IODs; the control group (n = 18, 84.1 ± 5.55 yrs) received conventional relines. During the first year, no implant was lost; however, 2 patients died. IODs proved more stable, and participants in the intervention group demonstrated significantly higher denture satisfaction as well as an increased oral health-related quality of life compared to the control group. Maximum voluntary bite force improved significantly with IODs, yet the chewing efficiency was not different between groups. Masseter muscle thickness increased with IODs, mainly on the preferred chewing side. Body mass index decreased in both groups, but the decline tended to be smaller in the intervention group; blood markers and the Mini Nutritional Assessment did not confirm this tendency. These results indicate that edentulous patients who depend on help for activities of daily living may benefit from IODs even late in life. PMID:24158342

  3. Stress and Fatigue Management Using Balneotherapy in a Short-Time Randomized Controlled Trial

    PubMed Central

    Razbadauskas, Artūras; Sąlyga, Jonas; Martinkėnas, Arvydas

    2016-01-01

    Objective. To investigate the influence of high-salinity geothermal mineral water on stress and fatigue. Method. 180 seamen were randomized into three groups: geothermal (65), music (50), and control (65). The geothermal group was administered 108 g/L salinity geothermal water bath for 2 weeks five times a week. Primary outcome was effect on stress and fatigue. Secondary outcomes were the effect on cognitive function, mood, and pain. Results. The improvements after balneotherapy were a reduction in the number and intensity of stress-related symptoms, a reduction in pain and general, physical, and mental fatigue, and an improvement in stress-related symptoms management, mood, activation, motivation, and cognitive functions with effect size from 0.8 to 2.3. In the music therapy group, there were significant positive changes in the number of stress symptoms, intensity, mood, pain, and activity with the effect size of 0.4 to 1.1. The researchers did not observe any significant positive changes in the control group. The comparison between the groups showed that balneotherapy was superior to music therapy and no treatment group. Conclusions. Balneotherapy is beneficial for stress and fatigue reduction in comparison with music or no therapy group. Geothermal water baths have a potential as an efficient approach to diminish stress caused by working or living conditions. PMID:27051455

  4. Stress and Fatigue Management Using Balneotherapy in a Short-Time Randomized Controlled Trial.

    PubMed

    Rapolienė, Lolita; Razbadauskas, Artūras; Sąlyga, Jonas; Martinkėnas, Arvydas

    2016-01-01

    Objective. To investigate the influence of high-salinity geothermal mineral water on stress and fatigue. Method. 180 seamen were randomized into three groups: geothermal (65), music (50), and control (65). The geothermal group was administered 108 g/L salinity geothermal water bath for 2 weeks five times a week. Primary outcome was effect on stress and fatigue. Secondary outcomes were the effect on cognitive function, mood, and pain. Results. The improvements after balneotherapy were a reduction in the number and intensity of stress-related symptoms, a reduction in pain and general, physical, and mental fatigue, and an improvement in stress-related symptoms management, mood, activation, motivation, and cognitive functions with effect size from 0.8 to 2.3. In the music therapy group, there were significant positive changes in the number of stress symptoms, intensity, mood, pain, and activity with the effect size of 0.4 to 1.1. The researchers did not observe any significant positive changes in the control group. The comparison between the groups showed that balneotherapy was superior to music therapy and no treatment group. Conclusions. Balneotherapy is beneficial for stress and fatigue reduction in comparison with music or no therapy group. Geothermal water baths have a potential as an efficient approach to diminish stress caused by working or living conditions. PMID:27051455

  5. Mental skills training with basic combat training soldiers: A group-randomized trial.

    PubMed

    Adler, Amy B; Bliese, Paul D; Pickering, Michael A; Hammermeister, Jon; Williams, Jason; Harada, Coreen; Csoka, Louis; Holliday, Bernie; Ohlson, Carl

    2015-11-01

    Cognitive skills training has been linked to greater skills, self-efficacy, and performance. Although research in a variety of organizational settings has demonstrated training efficacy, few studies have assessed cognitive skills training using rigorous, longitudinal, randomized trials with active controls. The present study examined cognitive skills training in a high-risk occupation by randomizing 48 platoons (N = 2,432 soldiers) in basic combat training to either (a) mental skills training or (b) an active comparison condition (military history). Surveys were conducted at baseline and 3 times across the 10-week course. Multilevel mixed-effects models revealed that soldiers in the mental skills training condition reported greater use of a range of cognitive skills and increased confidence relative to those in the control condition. Soldiers in the mental skills training condition also performed better on obstacle course events, rappelling, physical fitness, and initial weapons qualification scores, although effects were generally moderated by gender and previous experience. Overall, effects were small; however, given the rigor of the design, the findings clearly contribute to the broader literature by providing supporting evidence that cognitive training skills can enhance performance in occupational and sports settings. Future research should address gender and experience to determine the need for targeting such training appropriately. PMID:26011718

  6. A Randomized Controlled Study Comparing Reverse Hybrid Therapy and Standard Triple Therapy for Helicobacter pylori Infection.

    PubMed

    Hsu, Ping-I; Kao, Sung-Shuo; Wu, Deng-Chyang; Chen, Wen-Chi; Peng, Nan-Jing; Yu, Hsien-Chung; Wang, Huay-Min; Lai, Kwok-Hung; Cheng, Jin-Shiung; Chen, Angela; Chuah, Seng-Kee; Tsay, Feng-Woei

    2015-12-01

    Reverse hybrid therapy is an 1-step 2-phase treatment for Helicobacter pylori (H. pylori) infection with less cost than standard triple therapy. We conducted a randomized, controlled study to compare the efficacies of standard triple therapy and reverse hybrid therapy in the treatment of H. pylori infection. From October 2012 to March 2015, consecutive H. pylori-infected subjects were randomly allocated to receive either a reverse hybrid therapy (pantoprazole plus amoxicillin for 12 days and clarithromycin plus metronidazole for the initial 7 days) or a standard triple therapy (pantoprazole plus amoxicillin and clarithromycin for 12 days). H. pylori status was assessed 6 weeks after treatment. Additionally, antibiotic resistances and host CYP2C19 genotypes were examined and analyzed. A total of 440 H. pylori-infected patients were randomly assigned to receive either a reverse hybrid (n = 220) or a standard triple therapy (n = 220). The reverse hybrid group had a higher eradication rate than standard triple group either by intention-to-treat (93.6% vs. 86.8%; P = 0.016) or per-protocol analysis (95.7% vs. 88.3%; P = 0.005). The 2 patient groups exhibited similar frequencies of overall adverse events (14.1% vs. 9.5%) and drug compliance (96.8% vs. 98.6%). Clarithromycin resistance was an independent risk factor predicting eradication failure in standard triple group (P < 0.001), but not in reverse hybrid group. CYP2C19 genotypes did not affect the eradication rates in both groups. Reverse hybrid therapy can be considered for first-line treatment of H. pylori infection since the new therapy achieves a higher eradication rate than standard triple therapy with similar tolerability and less pharmaceutical cost. PMID:26632893

  7. A Randomized Controlled Study Comparing Reverse Hybrid Therapy and Standard Triple Therapy for Helicobacter pylori Infection

    PubMed Central

    Hsu, Ping-I; Kao, Sung-Shuo; Wu, Deng-Chyang; Chen, Wen-Chi; Peng, Nan-Jing; Yu, Hsien-Chung; Wang, Huay-Min; Lai, Kwok-Hung; Cheng, Jin-Shiung; Chen, Angela; Chuah, Seng-Kee; Tsay, Feng-Woei

    2015-01-01

    Abstract Reverse hybrid therapy is an 1-step 2-phase treatment for Helicobacter pylori (H. pylori) infection with less cost than standard triple therapy. We conducted a randomized, controlled study to compare the efficacies of standard triple therapy and reverse hybrid therapy in the treatment of H. pylori infection. From October 2012 to March 2015, consecutive H. pylori-infected subjects were randomly allocated to receive either a reverse hybrid therapy (pantoprazole plus amoxicillin for 12 days and clarithromycin plus metronidazole for the initial 7 days) or a standard triple therapy (pantoprazole plus amoxicillin and clarithromycin for 12 days). H. pylori status was assessed 6 weeks after treatment. Additionally, antibiotic resistances and host CYP2C19 genotypes were examined and analyzed. A total of 440 H. pylori-infected patients were randomly assigned to receive either a reverse hybrid (n = 220) or a standard triple therapy (n = 220). The reverse hybrid group had a higher eradication rate than standard triple group either by intention-to-treat (93.6% vs. 86.8%; P = 0.016) or per-protocol analysis (95.7% vs. 88.3%; P = 0.005). The 2 patient groups exhibited similar frequencies of overall adverse events (14.1% vs. 9.5%) and drug compliance (96.8% vs. 98.6%). Clarithromycin resistance was an independent risk factor predicting eradication failure in standard triple group (P < 0.001), but not in reverse hybrid group. CYP2C19 genotypes did not affect the eradication rates in both groups. Reverse hybrid therapy can be considered for first-line treatment of H. pylori infection since the new therapy achieves a higher eradication rate than standard triple therapy with similar tolerability and less pharmaceutical cost. PMID:26632893

  8. Training Mentors of Clinical and Translational Research Scholars: A Randomized Controlled Trial

    PubMed Central

    Pfund, Christine; House, Stephanie C.; Asquith, Pamela; Fleming, Michael F.; Buhr, Kevin A.; Burnham, Ellen L.; Gilmore, Julie M. Eichenberger; Huskins, W. Charles; McGee, Richard; Schurr, Kathryn; Shapiro, Eugene D.; Spencer, Kimberly C.; Sorkness, Christine A.

    2014-01-01

    Purpose To determine whether a structured mentoring curriculum improves research mentoring skills. Method The authors conducted a randomized controlled trial (RCT) at 16 academic health centers (June 2010 to July 2011). Faculty mentors of trainees who were conducting clinical/translational research ≥50% of the time were eligible. The intervention was an eight-hour, case-based curriculum focused on six mentoring competencies. The primary outcome was the change in mentors’ self-reported pretest to posttest composite scores on the Mentoring Competency Assessment (MCA). Secondary outcomes included changes in the following: mentors’ awareness as measured by their self-reported retrospective change in MCA scores, mentees’ ratings of their mentors’ competency as measured by MCA scores, and mentoring behaviors as reported by mentors and their mentees. Results A total of 283 mentor–mentee pairs were enrolled: 144 mentors were randomized to the intervention; 139 to the control condition. Self-reported pre-/posttest change in MCA composite scores was higher for mentors in the intervention group compared with controls (P < .001). Retrospective changes in MCA composite scores between the two groups were even greater, and extended to all six subscale scores (P < .001). More intervention-group mentors reported changes in their mentoring practices than control mentors (P < .001). Mentees working with intervention-group mentors reported larger changes in retrospective MCA pre-/posttest scores (P = .003) and more changes in their mentors’ behavior (P = .002) than those paired with control mentors. Conclusions This RCT demonstrates that a competency-based research mentor training program can improve mentors’ skills. PMID:24667509

  9. Massage Therapy for Patients with Metastatic Cancer: A Pilot Randomized Controlled Trial

    PubMed Central

    Toth, Maria; Marcantonio, Edward R.; Davis, Roger B.; Walton, Tracy; Kahn, Janet R.

    2013-01-01

    Abstract Objectives The study objectives were to determine the feasibility and effects of providing therapeutic massage at home for patients with metastatic cancer. Design This was a randomized controlled trial. Settings/location Patients were enrolled at Oncology Clinics at a large urban academic medical center; massage therapy was provided in patients' homes. Subjects Subjects were patients with metastatic cancer. Interventions There were three interventions: massage therapy, no-touch intervention, and usual care. Outcome measures Primary outcomes were pain, anxiety, and alertness; secondary outcomes were quality of life and sleep. Results In this study, it was possible to provide interventions for all patients at home by professional massage therapists. The mean number of massage therapy sessions per patient was 2.8. A significant improvement was found in the quality of life of the patients who received massage therapy after 1-week follow-up, which was not observed in either the No Touch control or the Usual Care control groups, but the difference was not sustained at 1 month. There were trends toward improvement in pain and sleep of the patients after therapeutic massage but not in patients in the control groups. There were no serious adverse events related to the interventions. Conclusions The study results showed that it is feasible to provide therapeutic massage at home for patients with advanced cancer, and to randomize patients to a no-touch intervention. Providing therapeutic massage improves the quality of life at the end of life for patients and may be associated with further beneficial effects, such as improvement in pain and sleep quality. Larger randomized controlled trials are needed to substantiate these findings. PMID:23368724

  10. 29 CFR 4001.3 - Trades or businesses under common control; controlled groups.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... control with such person. (2) Persons are under common control if they are members of a “controlled group... 29 Labor 9 2013-07-01 2013-07-01 false Trades or businesses under common control; controlled... CORPORATION GENERAL TERMINOLOGY § 4001.3 Trades or businesses under common control; controlled groups....

  11. 29 CFR 4001.3 - Trades or businesses under common control; controlled groups.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... control with such person. (2) Persons are under common control if they are members of a “controlled group... 29 Labor 9 2012-07-01 2012-07-01 false Trades or businesses under common control; controlled... CORPORATION GENERAL TERMINOLOGY § 4001.3 Trades or businesses under common control; controlled groups....

  12. 29 CFR 4001.3 - Trades or businesses under common control; controlled groups.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... control with such person. (2) Persons are under common control if they are members of a “controlled group... 29 Labor 9 2011-07-01 2011-07-01 false Trades or businesses under common control; controlled... CORPORATION GENERAL TERMINOLOGY § 4001.3 Trades or businesses under common control; controlled groups....

  13. Effects of Native Type II Collagen Treatment on Knee Osteoarthritis: A Randomized Controlled Trial

    PubMed Central

    Bakilan, Fulya; Armagan, Onur; Ozgen, Merih; Tascioglu, Funda; Bolluk, Ozge; Alatas, Ozkan

    2016-01-01

    Objective: The aim of this randomized controlled study was to evaluate the efficacy of oral native type II collagen treatment on the symptoms and biological markers of cartilage degradation, when given concomitantly with acetaminophen in patients with knee osteoarthritis. Materials and Methods: Thirty-nine patients diagnosed with knee osteoarthritis were included and randomly distributed into two groups: one treated with 1500 mg/day of acetaminophen (group AC; n=19) and the other treated with 1500 mg/day of acetaminophen plus 10 mg/day of native type II collagen (group AC+CII; n=20) for 3 months. Visual Analogue Scale (VAS) at rest and during walking, Western Ontario McMaster (WOMAC) pain, WOMAC function, and Short Form-36 (SF-36) scores, were recorded. Coll2-1, Coll2-1NO2 and Fibulin-3 levels were quantified in urine as biomarkers of disease progression. ClinicalTrials.gov: NCT02237989. Results: After 3 months of treatment, significant improvements compared to baseline were reported in joint pain (VAS walking), function (WOMAC) and quality of life (SF-36) in the AC+CII group, while only improvements in some subscales of the SF-36 survey and VAS walking were detected in the AC group. Comparisons between the groups revealed a significant difference in VAS walking score in favour of the AC+CII group as compared to AC group. Biochemical markers of cartilage degradation in urine did not significantly improve in any of the groups. Conclusion: All in all, these results suggest that native type II collagen treatment combined with acetaminophen is superior to only acetaminophen for symptomatic treatment of patients with knee osteoarthritis. PMID:27551171

  14. Reducing HIV-Related Stigma in Health Care Settings: A Randomized Controlled Trial in China

    PubMed Central

    Wu, Zunyou; Liang, Li-Jung; Guan, Jihui; Jia, Manhong; Rou, Keming; Yan, Zhihua

    2013-01-01

    Objectives. The objective of the intervention was to reduce service providers’ stigmatizing attitudes and behaviors toward people living with HIV. Methods. The randomized controlled trial was conducted in 40 county-level hospitals in 2 provinces of China between October 2008 and February 2010. Forty-four service providers were randomly selected from each hospital, yielding a total of 1760 study participants. We randomized the hospitals to either an intervention condition or a control condition. In the intervention hospitals, about 15% of the popular opinion leaders were identified and trained to disseminate stigma reduction messages. Results. We observed significant improvements for the intervention group in reducing prejudicial attitudes (P < .001), reducing avoidance intent towards people living with HIV (P < .001), and increasing institutional support in the hospitals (P = .003) at 6 months after controlling for service providers’ background factors and clinic-level characteristics. The intervention effects were sustained and strengthened at 12 months. Conclusions. The intervention reduced stigmatizing attitudes and behaviors among service providers. It has the potential to be integrated into the health care systems in China and other countries. PMID:23237175

  15. Effects of Probiotics on Quality of Life in Children with Cystic Fibrosis; A Randomized Controlled Trial

    PubMed Central

    Jafari, Seyed-Ali; Mehdizadeh-Hakkak, Atieh; Kianifar, Hamid-Reza; Hebrani, Paria; Ahanchian, Hamid; Abbasnejad, Elaheh

    2013-01-01

    Objective Patients with cystic fibrosis (CF) usually have abnormal intestinal microbiota and dysregulated immune mediators due to massive exposure to antibiotics. Probiotics as immunomodulatory and anti-inflammatory substances are considered to improve both clinical and biochemical intestinal and pulmonary function in CF patients. We decided to investigate the effects of probiotics on quality of life and pulmonary exacerbations in children with cystic fibrosis. Methods In a prospective, randomized, controlled clinical trial, 37 CF patients (2-12 years old) were randomly divided into two groups. 20 patients of probiotic group took probiotics (2×109CFU/d) for one month while 17 patients of control group took placebo capsules. Quality of life was determined using PedsQL™4.0 questionnaire at the beginning, then three and six months after completing the treatment period. Rate of pulmonary exacerbation in probiotic group patients was also evaluated during three months after intervention and compared to the same three months of the previous year. Results were analyzed using SPSS (11.5). P<0.05 was considered statistically significant. Findings Significant improvement was observed in the mean total score of parent reported quality of life among probiotic group patients in comparison with placebo group at 3rd month (P=0.01), but this was not significant at 6th month of probiotic treatment. Rate of pulmonary exacerbation was significantly reduced among probiotic group (P<0.01). Conclusion Probiotics are considered as useful nutritional supplements on reducing number of pulmonary exacerbations and improving quality of life in patients with cystic fibrosis. Effects of probiotics seem to be temporary and probably continuous ingestion might have more stable improving effects on quality of life. PMID:24910746

  16. A comparison of two stretching programs for hamstring muscles: A randomized controlled assessor-blinded study.

    PubMed

    Demoulin, Christophe; Wolfs, Sébastien; Chevalier, Madeline; Granado, Caroline; Grosdent, Stéphanie; Depas, Yannick; Roussel, Nathalie; Hage, Renaud; Vanderthommen, Marc

    2016-01-01

    Most parameters regarding hamstring flexibility training programs have been investigated; however, the joint (i.e. hip or knee) on which the stretching should preferentially be focused needs to be further explored. This randomized controlled assessor-blinded study aimed to investigate the influence of this parameter. We randomly assigned 111 asymptomatic participants with tight hamstring muscles in three groups: a control group and two groups following a different home-based 8-week (five 10-minute sessions per week) hamstring stretching program (i.e. stretching performed by flexing the hip while keeping the knee extended [SH] or by first flexing the hip with a flexed knee and then extending the knee [SK]). Range of motion (ROM) of hip flexion and knee extension were measured before and after the stretching program by means of the straight leg raising test and the passive knee extension angle test, respectively. Eighty-nine participants completed the study. A significant increase in ROM was observed at post-test. Analyses showed significant group-by-time interactions for changes regarding all outcomes. Whereas the increase in hip flexion and knee extension ROM was higher in the stretching groups than in the CG (especially for the SH group p < 0.05), no differences between the two stretching groups were observed (p > 0.05). In conclusion, the fact that both stretching programs resulted in similar results suggests no influence of the joint at which the stretching is focused upon, as assessed by the straight leg raising and knee extension angle tests. PMID:26756214

  17. Operating Room Time Savings with the Use of Splint Packs: A Randomized Controlled Trial

    PubMed Central

    Gonzalez, Tyler A.; Bluman, Eric M.; Palms, David; Smith, Jeremy T.; Chiodo, Christopher P.

    2016-01-01

    Background: The most expensive variable in the operating room (OR) is time. Lean Process Management is being used in the medical field to improve efficiency in the OR. Streamlining individual processes within the OR is crucial to a comprehensive time saving and cost-cutting health care strategy. At our institution, one hour of OR time costs approximately $500, exclusive of supply and personnel costs. Commercially prepared splint packs (SP) contain all components necessary for plaster-of-Paris short-leg splint application and have the potential to decrease splint application time and overall costs by making it a more lean process. We conducted a randomized controlled trial comparing OR time savings between SP use and bulk supply (BS) splint application. Methods: Fifty consecutive adult operative patients on whom post-operative short-leg splint immobilization was indicated were randomized to either a control group using BS or an experimental group using SP. One orthopaedic surgeon (EMB) prepared and applied all of the splints in a standardized fashion. Retrieval time, preparation time, splint application time, and total splinting time for both groups were measured and statistically analyzed. Results: The retrieval time, preparation time and total splinting time were significantly less (p<0.001) in the SP group compared with the BS group. There was no significant difference in application time between the SP group and BS group. Conclusion: The use of SP made the process of splinting more lean. This has resulted in an average of 2 minutes 52 seconds saved in total splinting time compared to BS, making it an effective cost-cutting and time saving technique. For high volume ORs, use of splint packs may contribute to substantial time and cost savings without impacting patient safety. PMID:26894212

  18. The effectiveness of massage therapy in the treatment of infantile colic symptoms: A randomized controlled trial

    PubMed Central

    Sheidaei, Ali; Abadi, Alireza; Zayeri, Farid; Nahidi, Fatemeh; Gazerani, Nafiseh; Mansouri, Anita

    2016-01-01

    Background: Infantile colic, cry-fuss and sleep problems are transient in the initial months of life, but they contribute to maternal depression, parenting stress and family mental health problems. In this randomized clinical trial, we aimed to explore the efficacy of massage therapy compared to rocking in reducing infantile colic symptoms including duration and number of cries, sleep duration and severity of infant colic. Methods: This was a single blind RCT study with a one-week follow-up. One hundred colicky infants aged younger than 12 weeks old were randomly assigned into massage and rocking groups. Infants in the massage group received a massage for 15-20 minutes once during a day and once at night before sleeping for a week. In the control group, mothers rocked their infants gently for 5-25 minutes when the symptoms of colic appeared. Parents recorded the details of the colic symptoms in a diary every day. A GEE approach was applied to explore the effect of the intervention. Results: Efficiency of massage therapy was significantly higher than rocking. At the end of the study, the mean number of daily cries was 4.26±1.40 in the massage and 6.9±2.14 the rocking groups (p<0.01). The mean of the severity score was 1.39±0.19 less in the massage group (p<0.01). Moreover, the mean differences of massage and rocking groups were -0.82±0.20 hour (p<0.01) and 0.72±0.35 (p= 0.04) in the duration of cries and duration of sleep, respectively. Conclusion: Massaging significantly improved colic symptoms during a one-week intervention for all outcomes. In addition, significant differences were found between the intervention and control groups in favor of massaging. Therefore, massage therapy is more effective than rocking for treating infant colic symptoms. PMID:27453882

  19. I-ONE therapy in patients undergoing total knee arthroplasty: a prospective, randomized and controlled study

    PubMed Central

    2012-01-01

    Background Total knee arthroplasty (TKA) is often associated with a severe local inflammatory reaction which, unless controlled, leads to persistent pain up to one year after surgery. Standard and accelerated rehabilitation protocols are currently being implemented after TKA, but no consensus exists regarding the long-term effects. Biophysical stimulation with pulsed electromagnetic fields (PEMFs) has been demonstrated to exert an anti-inflammatory effect, to promote early functional recovery and to maintain a positive long-term effect in patients undergoing joint arthroscopy. The aim of this study was to evaluate whether PEMFs can be used to limit the pain and enhance patient recovery after TKA. Methods A prospective, randomized, controlled study in 30 patients undergoing TKA was conducted. Patients were randomized into experimental PEMFs or a control group. Patients in the experimental group were instructed to use I-ONE stimulator 4hours/day for 60days. Postoperatively, all patients received the same rehabilitation program. Treatment outcome was assessed using the Knee Society Score, SF-36 Health-Survey and VAS. Patients were evaluated pre-operatively and one, two, six and 12 months after TKA. Joint swelling and Non Steroidal Anti Inflammatory Drug (NSAID) consumption were recorded. Comparisons between the two groups were carried out using a two-tail heteroschedastic Student’s t-test. Analysis of variance for each individual subject during the study was performed using ANOVA for multiple comparisons, applied on each group, and a Dunnet post hoc test. A p value < 0.05 was considered statistically significant. Results Pre-operatively, no differences were observed between groups in terms of age, sex, weight, height, Knee-Score, VAS, SF-36 and joint swelling, with the exception of the Functional Score. The Knee-Score, SF-36 and VAS demonstrated significantly positive outcomes in the I-ONE stimulated group compared with the controls at follow-ups. In the I

  20. Change in Pulmonary Function after Incentive Spirometer Exercise in Children with Spastic Cerebral Palsy: A Randomized Controlled Study

    PubMed Central

    Choi, Ja Young; Rha, Dong-wook

    2016-01-01

    Purpose The aim of this study was to investigate the effect of incentive spirometer exercise (ISE) on pulmonary function and maximal phonation time (MPT) in children with spastic cerebral palsy (CP). Materials and Methods Fifty children with CP were randomly assigned to two groups: the experimental group and the control group. Both groups underwent comprehensive rehabilitation therapy. The experimental group underwent additional ISE. The forced vital capacity (FVC), forced expiratory volume at one second (FEV1), FEV1/FVC ratio, peak expiratory flow (PEF), and MPT were assessed as outcome measures before and after 4 weeks of training. Results There were significant improvements in FVC, FEV1, PEF, and MPT in the experimental group, but not in the control group. In addition, the improvements in FVC, FEV1, and MPT were significantly greater in the experimental group than in the control group. Conclusion The results of this randomized controlled study support the use of ISE for enhancing pulmonary function and breath control for speech production in children with CP. PMID:26996580

  1. The differential influences of positive affect, random reward, and performance-contingent reward on cognitive control.

    PubMed

    Fröber, Kerstin; Dreisbach, Gesine

    2014-06-01

    Growing evidence suggests that positive affect and reward have differential effects on cognitive control. So far, however, these effects have never been studied together. Here, the authors present one behavioral study investigating the influences of positive affect and reward (contingent and noncontingent) on proactive control. A modified version of the AX-continuous performance task, which has repeatedly been shown to be sensitive to reward and affect manipulations, was used. In a first phase, two experimental groups received either neutral or positive affective pictures before every trial. In a second phase, the two halves of a given affect group additionally received, respectively, performance-contingent or random rewards. The results replicated the typical affect effect, in terms of reduced proactive control under positive as compared to neutral affect. Also, the typical reward effects associated with increased proactive control were replicated. Most interestingly, performance-contingent reward counteracted the positive affect effect, whereas random reward mirrored that effect. In sum, this study provides first evidence that performance-contingent reward, on the one hand, and positive affect and performance-noncontingent reward, on the other hand, have oppositional effects on cognitive control: Only performance-contingent reward showed a motivational effect in terms of a strategy shift toward increased proactive control, whereas positive affect alone and performance-noncontingent reward reduced proactive control. Moreover, the integrative design of this study revealed the vulnerability of positive affect effects to motivational manipulations. The results are discussed with respect to current neuroscientific theories of the effects of dopamine on affect, reward, and cognitive control. PMID:24659000

  2. Self-Monitoring of Blood Pressure for Improving Adherence to Antihypertensive Medicines and Blood Pressure Control: A Randomized Controlled Trial

    PubMed Central

    Hosseininasab, Masumeh; Jahangard-Rafsanjani, Zahra; Mohagheghi, Abbas; Sarayani, Amir; Rashidian, Arash; Javadi, Mohammadreza; Ahmadvand, Alireza; Hadjibabaie, Molouk

    2014-01-01

    BACKGROUND Self-monitoring is reported to have limited efficacy for hypertension management in high-income countries. In this study, we aimed to evaluate the effect of self-monitoring on blood pressure (BP) control in an Iranian population. METHODS A randomized controlled trial was conducted on 196 mild to moderate hypertensive patients in an outpatient cardiovascular clinic. Patients in the intervention group received a wrist self-monitoring device and were educated to measure and document their BP daily during the study period (24 weeks). Patients in the control group received usual care. Three follow-up visits with the physician were scheduled for all patients (weeks 4, 12, and 24), and the investigator assessed adherence to medications after each visit (pill counting). The primary outcome (BP) was compared between groups using repeated-measure analysis of variance. RESULTS One hundred ninety patients completed the study. Systolic BP (144.4±7.4 vs 145.9±6.4mm Hg) and diastolic BP (85.5±6.9 vs. 85.1±7.7mm Hg) were similar between groups at baseline. The trend of BP was not significantly different between groups during the study period. Systolic and diastolic BP decreased significantly in both groups at the first follow-up visit (systolic BP: 132.6 vs. 133.4mm Hg; diastolic BP: 77.4 vs. 77.2mm Hg). In the intervention group, we observed a small continued decrease in diastolic BP up to week 24 BP (P = 0.01). Both groups showed adherence rates >95% during the study period. CONCLUSIONS Our study could not confirm that self-monitoring can improve BP control in patients with frequent medical visits. PMID:24771706

  3. Auricular acupuncture for chemically dependent pregnant women: a randomized controlled trial of the NADA protocol

    PubMed Central

    2012-01-01

    Background The prevalence of maternal drug use during pregnancy in North America has been estimated to be as high as 6-10%. The consequences for the newborn include increased risk for perinatal mortality and ongoing physical, neurobehavioral, and psychosocial problems. Methadone is frequently used to wean women off street drugs but is implicated as a cause of adverse fetal/neonatal outcomes itself. The purpose of our study was to test the ability of maternal acupuncture treatment among mothers who use illicit drugs to reduce the frequency and severity of withdrawal symptoms among their newborns. Methods We randomly assigned chemically dependent pregnant women at BC Women’s Hospital in Vancouver, British Columbia to daily acupuncture treatments versus usual care. By necessity, neither our participants nor acupuncturists were blinded as to treatment allocation. Our primary outcome was days of neonatal morphine treatment for symptoms of neonatal withdrawal. Secondary neonatal outcomes included admission to a neonatal ICU and transfer to foster care. Results We randomized 50 women to acupuncture and 39 to standard care. When analyzed by randomized groups, we did not find benefit of acupuncture; the average length of treatment with morphine for newborns in the acupuncture group was 2.7 (6.3) compared to 2.8 (7.0) in the control group. Among newborns of women who were compliant with the acupuncture regime, we observed a reduction of 2.1 and 1.5 days in length of treatment for neonatal abstinence syndrome compared to the non-compliant and control groups, respectively. These differences were not statistically significant. Conclusions Acupuncture may be a safe and feasible treatment to assist mothers to reduce their dosage of methadone. Our results should encourage ongoing studies to test the ability of acupuncture to mitigate the severity of neonatal abstinence syndrome among their newborns. Clinical Trial Registration http://www.clinicaltrials.gov registry: W05

  4. Traumatic Brain Injury in Latin America: Lifespan Analysis Randomized Control Trial Protocol

    PubMed Central

    Chesnut, Randall M.; Temkin, Nancy; Carney, Nancy; Dikmen, Sureyya; Pridgeon, Jim; Barber, Jason; Celix, Juanita M.; Chaddock, Kelley; Cherner, Marianna; Hendrix, Terence; Lujan, Silvia; Machamer, Joan; Petroni, Gustavo; Rondina, Carlos; Videtta, Walter

    2012-01-01

    Background Although in the developed world the intracranial pressure (ICP) monitor is considered “standard of care” for patients with severe traumatic brain injury (TBI), its usefulness to direct treatment decisions has never been tested rigorously. Objective The primary focus is to conduct a high quality randomized, controlled trial to determine if ICP monitoring used to direct TBI treatment improves patient outcomes. By providing education, equipment, and structure, the project will enhance the research capacity of the collaborating investigators and will foster the collaborations established during earlier studies (add refs to papers from earlier studies). Methods Study centers were selected that routinely treated ICP based on clinical examination and CT imaging using internal protocols. We randomize patients to either an ICP Monitor Group or an Imaging and Clinical Examination Group. Treatment decisions for the ICP Monitor Group are guided by ICP monitoring, based on established guidelines. Treatment decisions for the Imaging and Clinical Examination Group are made using a single protocol derived from those previously being used at those centers. Expected Outcomes There are two study hypotheses: 1) Patients with severe TBI whose acute care treatment is managed using ICP monitors will have improved outcomes and 2) incorporating ICP monitoring into the care of patients with severe TBI will minimize complications and decrease length of ICU stay. Discussion This clinical trial tests the effectiveness of a management protocol based on technology considered pivotal to brain trauma treatment in the developed world - the ICP monitor. A randomized controlled trial of ICP monitoring has never been performed - a critical gap in the evidence base that supports the role of ICP monitoring in TBI care. As such, the results of this RCT will have global implications regardless of the level of development of the trauma system. PMID:22986600

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

    PubMed Central

    Jochems, Eline C; van der Feltz-Cornelis, Christina M; van Dam, Arno; Duivenvoorden, Hugo J; Mulder, Cornelis L

    2015-01-01

    Objective To evaluate the effectiveness of providing clinicians with regular feedback on the patient’s motivation for treatment in increasing treatment engagement in patients with severe mental illness. Methods Design: cluster randomized controlled trial (Dutch Trials Registry NTR2968). Participants: adult outpatients with a primary diagnosis of a psychotic disorder or a personality disorder and their clinicians, treated in 12 community mental health teams (the clusters) of two mental health institutions in the Netherlands. Interventions: monthly motivation feedback (MF) generated by clinicians additional to treatment as usual (TAU) and TAU by the community mental health teams. Primary outcome: treatment engagement at patient level, assessed at 12 months by clinicians. Randomization: teams were allocated to MF or TAU by a computerized randomization program that randomized each team to a single treatment by blocks of varying size. All participants within these teams received similar treatment. Clinicians and patients were not blind to treatment allocation at the 12-month assessment. Results The 294 randomized patients (148 MF, 146 TAU) and 57 clinicians (29 MF, 28 TAU) of 12 teams (6 MF, 6 TAU) were analyzed according to the intention-to-treat principle. No statistically significant differences between treatment groups on treatment engagement were found (adjusted mean difference =0.1, 95% confidence interval =−2.2 to 2.3, P=0.96, d=0). Preplanned ancillary analyses showed statistically significant interaction effects between treatment group and primary diagnosis on treatment motivation and quality of life (secondary outcomes), which were beneficial for patients with a primary diagnosis of a personality disorder but not for those with a psychotic disorder. There were no reports of adverse events. Conclusion The current findings imply that monitoring and discussing the patient’s motivation is insufficient to improve motivation and treatment engagement, and

  6. AIDS Clinical Trials Group Longitudinal Linked Randomized Trials (ALLRT): Rationale, Design, and Baseline Characteristics

    PubMed Central

    Smurzynski, Marlene; Collier, Ann C.; Koletar, Susan L.; Bosch, Ronald J.; Wu, Kunling; Bastow, Barbara; Benson, Constance A.

    2009-01-01

    Purpose ALLRT is a longitudinal cohort study of HIV-infected subjects prospectively randomized into selected clinical trials for antiretroviral (ARV) treatment-naïve and ARV treatment-experienced individuals conducted by the AIDS Clinical Trials Group (ACTG). We describe the rationale, design, and baseline characteristics of the ALLRT cohort and its potential to address important research questions related to ARV therapy. Method Standardized visits occur every 16 weeks to evaluate long-term clinical, virologic, and immunologic outcomes associated with ARV treatment. Results A total of 4,371 subjects enrolled in ALLRT from January 2000 through June 2007. Of these, 3,146 (72%) were ARV naïve at parent study entry (18% female, 44% white, 32% black, 21% Hispanic; median age 37 years, CD4 count 218 cells/μL, follow-up 3.6 years; 343 [11%] followed ≥8 years) and 1,225 (28%) were treatment experienced (13% female, 59% white, 20% black, 17% Hispanic; median age 42 years, CD4 count 325 cells/μL, follow-up 5.7 years). Conclusions ALLRT provides the opportunity to understand long-term ramifications of therapeutic ARV choices and determine whether these vary by treatment regimen, timing of treatment initiation, or treatment changes over long-term follow-up. Investigations based on uniform data and specimen collection in the context of randomized ARV treatments will be critical to developing more successful long-term therapeutic strategies for HIV treatment. PMID:18753121

  7. Use of probiotics in HIV-infected children: a randomized double-blind controlled study.

    PubMed

    Trois, Lívia; Cardoso, Edmundo Machado; Miura, Ernani

    2008-02-01

    HIV/AIDS is an infection characterized by immune cell dysfunction and subsequent immunodeficiency, as well as intestinal disorder. Probiotics are live microbial feed supplements that beneficially affect the host animal by improving intestinal microbial balance and promoting health benefits. The goals of this study were to determine whether the use of probiotics could improve the immune response determined by CD4 cells mm(-3) counts and reduce liquid stool episodes. A randomized double-blind controlled trial with 77 HIV-infected children (2-12 years), divided into two groups: one receiving probiotics (formula containing Bifidobacterium bifidum with Streptococcus thermophilus -2.5 x 10(10) colony forming units) and the other, a standard formula (control group), for 2 months. The CD4 counts (cells mm(-3)) were collected at the beginning and end of the study. The quality and number of stools were assessed by a questionnaire (watery to normal stool consistency). There was an increase in the mean CD4 count in the probiotics group (791 cells mm(-3)) and a small decrease in the control group (538 cells mm(-3)). The change from baseline in mean CD4 cell count was +118 cells mm(-3) vs. -42 cells mm(-3) for children receiving the probiotic formula and control formula, respectively (p = 0.049). A similar reduction in liquid stool consistency in both the groups (p < 0.06), with a slight enhancement in the probiotics group, was observed, but without significant difference (p < 0.522). The incidence of loose-soft stools showed a small decrease in both groups (p < 0.955) and there was an increase in the incidence of normal stool consistency in both the groups (p < 0.01). Our study showed that probiotics have immunostimulatory properties and might be helpful in the treatment of HIV-infected children. PMID:17878180

  8. Persistent effects of a message counter-marketing light cigarettes: results of a randomized controlled trial.

    PubMed

    Kozlowski, L T; Palmer, R; Stine, M M; Strasser, A A; Yost, B A

    2001-01-01

    In a randomized, controlled trial, a national sample of smokers of Light cigarettes heard by telephone a "radio message" counter-marketing Light cigarettes. This message caused immediate changes in beliefs. Follow-up telephone interviews were done about 7 months later. The Message Group (N = 181) was more likely than the Control Group (N = 85) to report that (a) one Light equaled one Regular in tar yield to smokers, (b) Lights did not decrease health risks, and (c) they wanted to give up smoking (P<.05); they did not report greater quitting or intention to quit, or greater knowledge of filter ventilation. Systematic counter-marketing of Lights is recommended. A telephone-based exposure and follow-up procedure could be a good way to study message effects. PMID:11436936

  9. Febuxostat improves endothelial function in hemodialysis patients with hyperuricemia: A randomized controlled study.

    PubMed

    Tsuruta, Yuki; Kikuchi, Kan; Tsuruta, Yukio; Sasaki, Yuko; Moriyama, Takahito; Itabashi, Mitsuyo; Takei, Takashi; Uchida, Keiko; Akiba, Takashi; Tsuchiya, Ken; Nitta, Kosaku

    2015-10-01

    Endothelial dysfunction is often found in both hyperuricemia and hemodialysis patients. Recent studies have shown that treating hyperuricemia with allopurinol improves endothelial dysfunction. This study is performed to assess the effect of febuxostat on endothelial dysfunction in hemodialysis patients with hyperuricemia. We randomly assigned 53 hemodialysis patients with hyperuricemia to a febuxostat (10 mg daily) group and a control group and measured flow-mediated dilation, serum uric acid (UA) levels, systolic and diastolic blood pressure, malondialdehyde-modified low-density lipoprotein (MDA-LDL), and highly sensitive C-reactive protein (hsCRP) at baseline and at the end of a 4-week study period. Flow-mediated dilation increased from 5.3% ± 2.4% to 8.9% ± 3.6% in the febuxostat group but did not change significantly in the control group. Treatment with febuxostat resulted in a significant decrease in serum UA level and a significant decrease in MDA-LDL compared with baseline, but no significant difference was observed in hsCRP level or blood pressure. No significant differences were observed in the control group. Febuxostat improved endothelial dysfunction and reduced serum UA levels and oxidative stress in hemodialysis patients with hyperuricemia. PMID:25998500

  10. The Use of Text Messaging to Promote Physical Activity in Working Women: A Randomized Controlled Trial

    PubMed Central

    Gell, Nancy M.; Wadsworth, Danielle D.

    2014-01-01

    Background The study evaluated the effects of a text message intervention on physical activity in adult working women. Methods Eighty-seven participants were randomized to an intervention (n=41) or control group (n=46). Pedometer step counts and measures of self-efficacy were collected at baseline, 12 and 24 weeks. Intervention participants received approximately three text messages per week that were motivational, informational, and specific to performing physical activity. Results ANCOVA results showed a significant difference between groups for mean steps/day at 12 weeks (6540.0 vs. 5685.0, p=.01) and no significant difference at 24 weeks (6867.7 vs. 6189.0, p= .06). There was no change in mean step counts during or after the intervention compared to baseline. There was a significant difference between groups for mean self-efficacy scores at 12 weeks (68.5, vs. 60.3, p=.02) and at 24 weeks (67.3 vs. 59.0, p=.03). Conclusions Intervention participants had higher step counts after 12 and 24 weeks compared to a control group; however, the difference was significant only at the midpoint of the intervention and was attributable to a decrease in steps for the control group. Text messaging did not increase step counts but may be a cost effective tool for maintenance of physical activity behavior. PMID:25110303

  11. Communication skills course in an Indian undergraduate dental curriculum: a randomized controlled trial.

    PubMed

    Sangappa, Sunila B; Tekian, Ara

    2013-08-01

    This study assessed the impact of a course on communication skills for third-year undergraduate dental students at a dental institute in India. A randomized pretest, posttest controlled trial was conducted with all the students from four cohorts of third-year dental undergraduate students, divided into an intervention group (n=30) and a control group (n=30). The course was developed using Kern's six-step approach to curriculum development. Needs assessment was ascertained, and readings, lectures, and role-plays with real and simulated patients were implemented. Encounters of students during two patient interviews (simulated and real) were rated by two raters using a twenty-seven-item dental consultation communication checklist with a rating scale 0 to 3. Students completed a questionnaire regarding their acceptance of the course. A 2×2 (group × time) ANOVA with group as a between-subjects factor (control vs. experimental) and time as a within-subjects factor (pre vs. post) was performed. The two groups did not differ at pretest but differed significantly at posttest. This study showed that simply attending to patients during a clinical course did not improve professional communication skills. In contrast, the implementation of a course on communication skills did improve the students' dentist-patient interactions. Integrating the teaching and development of a relevant, outcome-based course on communication skills provided clear evidence of communication skills acquisition among these dental students. The course could be introduced in other Indian dental schools. PMID:23929580

  12. Psychological Distress Because of Asking about Suicidal Thoughts: A Randomized Controlled Trial among Students.

    PubMed

    de Beurs, D P; Ghoncheh, R; Geraedts, A S; Kerkhof, A J F M

    2016-01-01

    The aim of this study was to investigate the effect of the questions from the Beck Scale for Suicide Ideation on psychological well-being among healthy participants. In a randomized controlled study, 301 participants completed the same 4 questionnaires on psychopathology. The experimental group additionally answered 21 items of the Beck Scale for Suicide Ideation. The control group answered 19 items on Quality of Life. The experimental group showed a significantly smaller decrease of negative affect compared to the control condition. When analyzing participants with an increase in distress, 80% were part of the experimental group. For most participants, answering questions about suicide does not affect their mood. A small group of participants did react with some distress to the questions about suicide. As the questions about suicide were administered immediately before the questions about negative affect, the questions about suicide could have worked as a negative mood challenge. Future experimental research should further investigate the effect of questions about suicide among healthy participants, especially on the long term. PMID:25751130

  13. Many-body localization phase transition: A simplified strong-randomness approximate renormalization group

    NASA Astrophysics Data System (ADS)

    Zhang, Liangsheng; Zhao, Bo; Devakul, Trithep; Huse, David A.

    2016-06-01

    We present a simplified strong-randomness renormalization group (RG) that captures some aspects of the many-body localization (MBL) phase transition in generic disordered one-dimensional systems. This RG can be formulated analytically and is mathematically equivalent to a domain coarsening model that has been previously solved. The critical fixed-point distribution and critical exponents (that satisfy the Chayes inequality) are thus obtained analytically or to numerical precision. This reproduces some, but not all, of the qualitative features of the MBL phase transition that are indicated by previous numerical work and approximate RG studies: our RG might serve as a "zeroth-order" approximation for future RG studies. One interesting feature that we highlight is that the rare Griffiths regions are fractal. For thermal Griffiths regions within the MBL phase, this feature might be qualitatively correctly captured by our RG. If this is correct beyond our approximations, then these Griffiths effects are stronger than has been previously assumed.

  14. Effect of olive oil massage on weight gain in preterm infants: A randomized controlled clinical trial

    PubMed Central

    Jabraeile, Mahnaz; Rasooly, Alehe Seyyed; Farshi, Mahni Rahkar; Malakouti, Jamileh

    2016-01-01

    Background: Despite the fact that effect of massage with or without oil on the baby's weight gain is not clear, but recent studies have shown that massage with essential oils make lipid absorption through the skin. The aim of this study was to evaluate the effect of olive oil massage on weight gain in preterm infants. Materials and Methods: This study was a sing