Clinical Trials in Vision Research

MedlinePlus

... the treatment group . If you are in the control group , you could receive the standard treatment for a ... Researchers randomly assign participants to the treatment and control groups. In most studies, you have an equal chance ...

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

ERIC Educational Resources Information Center

Rhoads, Christopher

2011-01-01

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

The Impact of Curriculum-Based Professional Development on Science Instruction: Results from a Cluster-Randomized Trial

ERIC Educational Resources Information Center

Taylor, Joseph; Kowalski, Susan; Getty, Stephen; Wilson, Christopher; Carlson, Janet

2011-01-01

This research is part of a larger, IES-funded study titled: "Measuring the Efficacy and Student Achievement of Research-based Instructional Materials in High School Multidisciplinary Science" (Award # R305K060142). The larger study seeks to use a cluster-randomized trial design, with schools as the unit of assignment, to make causal…

A brief randomized controlled intervention targeting parents improves grades during middle school.

PubMed

Destin, Mesmin; Svoboda, Ryan C

2017-04-01

Despite a growing number of brief, psychosocial interventions that improve academic achievement, little research investigates how to leverage parents during such efforts. We designed and tested a randomized controlled intervention targeting parents to influence important discussions about the future and responses to academic difficulty experienced by their adolescent during eighth grade in the United States. We recruited experienced parents to convey the main messages of the intervention in a parent panel format. As expected, current parents who were randomly assigned to observe the parent panel subsequently planned to talk with their adolescents sooner about future opportunities and to respond more positively to experiences of academic difficulty than parents who were randomly assigned to a control group. The intervention also led to a significant increase in student grades, which was mediated by parents' responses to academic difficulty. We suggest an increase in experimental research that utilizes parents to influence student achievement. Copyright © 2017 The Foundation for Professionals in Services for Adolescents. Published by Elsevier Ltd. All rights reserved.

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

PubMed

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

2014-01-01

Minimal-risk randomized trials that can be embedded in practice could facilitate learning health-care systems. A cluster-randomized design was proposed to compare treatment strategies by assigning clusters (eg, providers) to "favor" a particular drug, with providers retaining autonomy for specific patients. Patient informed consent might be waived, broadening inclusion. However, it is not known if providers will adhere to the assignment or whether institutional review boards will waive consent. We evaluated the feasibility of this trial design. Agreeable providers were randomized to "favor" either hydrochlorothiazide or chlorthalidone when starting patients on thiazide-type therapy for hypertension. The assignment applied when the provider had already decided to start a thiazide, and providers could deviate from the strategy as needed. Prescriptions were aggregated to produce a provider strategy-adherence rate. All four institutional review boards waived documentation of patient consent. Providers (n=18) followed their assigned strategy for most of their new thiazide prescriptions (n=138 patients). In the "favor hydrochlorothiazide" group, there was 99% adherence to that strategy. In the "favor chlorthalidone" group, chlorthalidone comprised 77% of new thiazide starts, up from 1% in the pre-study period. When the assigned strategy was followed, dosing in the recommended range was 48% for hydrochlorothiazide (25-50 mg/day) and 100% for chlorthalidone (12.5-25.0 mg/day). Providers were motivated to participate by a desire to contribute to a comparative effectiveness study. A study promotional mug, provider information letter, and interactions with the site investigator were identified as most helpful in reminding providers of their study drug strategy. Providers prescribed according to an assigned drug-choice strategy most of the time for the purpose of a comparative effectiveness study. This simple design could facilitate research participation and behavior change in non-research clinicians. Waiver of patient consent can broaden the representation of patients, providers, and settings.

WWC Review of the Report "Accommodations for English Language Learner Students: The Effect of Linguistic Modification of Math Test Item Sets"

ERIC Educational Resources Information Center

What Works Clearinghouse, 2012

2012-01-01

The research described in this report is a randomized controlled trial in which seventh- and eighth-grade students were randomly assigned to complete a set of 25 math questions delivered with either standard language or language that had undergone "linguistic modification" by the research team. The purpose of the study was to assess the…

Examining an Alternative to Score Equating: A Randomly Equivalent Forms Approach. Research Report. ETS RR-08-14

ERIC Educational Resources Information Center

Liao, Chi-Wen; Livingston, Samuel A.

2008-01-01

Randomly equivalent forms (REF) of tests in listening and reading for nonnative speakers of English were created by stratified random assignment of items to forms, stratifying on item content and predicted difficulty. The study included 50 replications of the procedure for each test. Each replication generated 2 REFs. The equivalence of those 2…

Leveraging Random Number Generation for Mastery of Learning in Teaching Quantitative Research Courses via an E-Learning Method

ERIC Educational Resources Information Center

Boonsathorn, Wasita; Charoen, Danuvasin; Dryver, Arthur L.

2014-01-01

E-Learning brings access to a powerful but often overlooked teaching tool: random number generation. Using random number generation, a practically infinite number of quantitative problem-solution sets can be created. In addition, within the e-learning context, in the spirit of the mastery of learning, it is possible to assign online quantitative…

76 FR 51056 - Notice of Random Assignment Study To Evaluate the YouthBuild Program; Request for Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-17

... assigned to the control group can re-apply to the YouthBuild program. The Department is soliciting comments... ``utilize appropriate methodology and research designs, including the use of control groups chosen by.... Accordingly, ETA is conducting a multisite control group evaluation to provide rigorous estimates [[Page 51058...

Randomized Trial of Suicide Gatekeeper Training for Social Work Students

ERIC Educational Resources Information Center

Jacobson, Jodi M.; Osteen, Phillip J.; Sharpe, Tanya L.; Pastoor, Jennifer B.

2012-01-01

Problem: Education and research on social work's role in preventing client suicide is limited. Method: Seventy advanced master of social work students were randomly assigned to either the training group (Question, Persuade, and Referral suicide gatekeeper training) or the control group. Outcomes measured over time included suicide knowledge,…

A Randomized Violence Prevention Trial with Comparison: Responses by Gender

ERIC Educational Resources Information Center

Griffin, James P., Jr.; Chen, Dungtsa; Eubanks, Adriane; Brantley, Katrina M.; Willis, Leigh A.

2007-01-01

Using random assignment of students to two intervention groups and a comparison school sample, the researchers evaluated a three-group school-based violence prevention program. The three groups were (1) a whole-school intervention, (2) whole-school, cognitive-behavioral and cultural enrichment training, and (3) no violence prevention. The…

The adaptive approach for storage assignment by mining data of warehouse management system for distribution centres

NASA Astrophysics Data System (ADS)

Ming-Huang Chiang, David; Lin, Chia-Ping; Chen, Mu-Chen

2011-05-01

Among distribution centre operations, order picking has been reported to be the most labour-intensive activity. Sophisticated storage assignment policies adopted to reduce the travel distance of order picking have been explored in the literature. Unfortunately, previous research has been devoted to locating entire products from scratch. Instead, this study intends to propose an adaptive approach, a Data Mining-based Storage Assignment approach (DMSA), to find the optimal storage assignment for newly delivered products that need to be put away when there is vacant shelf space in a distribution centre. In the DMSA, a new association index (AIX) is developed to evaluate the fitness between the put away products and the unassigned storage locations by applying association rule mining. With AIX, the storage location assignment problem (SLAP) can be formulated and solved as a binary integer programming. To evaluate the performance of DMSA, a real-world order database of a distribution centre is obtained and used to compare the results from DMSA with a random assignment approach. It turns out that DMSA outperforms random assignment as the number of put away products and the proportion of put away products with high turnover rates increase.

Intraclass Correlations and Covariate Outcome Correlations for Planning Two-and Three-Level Cluster-Randomized Experiments in Education

ERIC Educational Resources Information Center

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

2013-01-01

Background: Cluster-randomized experiments that assign intact groups such as schools or school districts to treatment conditions are increasingly common in educational research. Such experiments are inherently multilevel designs whose sensitivity (statistical power and precision of estimates) depends on the variance decomposition across levels.…

Intraclass Correlations and Covariate Outcome Correlations for Planning 2 and 3 Level Cluster Randomized Experiments in Education

ERIC Educational Resources Information Center

Hedges, Larry V.; Hedberg, Eric C.

2013-01-01

Background: Cluster randomized experiments that assign intact groups such as schools or school districts to treatment conditions are increasingly common in educational research. Such experiments are inherently multilevel designs whose sensitivity (statistical power and precision of estimates) depends on the variance decomposition across levels.…

Design approaches to experimental mediation☆

PubMed Central

Pirlott, Angela G.; MacKinnon, David P.

2016-01-01

Identifying causal mechanisms has become a cornerstone of experimental social psychology, and editors in top social psychology journals champion the use of mediation methods, particularly innovative ones when possible (e.g. Halberstadt, 2010, Smith, 2012). Commonly, studies in experimental social psychology randomly assign participants to levels of the independent variable and measure the mediating and dependent variables, and the mediator is assumed to causally affect the dependent variable. However, participants are not randomly assigned to levels of the mediating variable(s), i.e., the relationship between the mediating and dependent variables is correlational. Although researchers likely know that correlational studies pose a risk of confounding, this problem seems forgotten when thinking about experimental designs randomly assigning participants to levels of the independent variable and measuring the mediator (i.e., “measurement-of-mediation” designs). Experimentally manipulating the mediator provides an approach to solving these problems, yet these methods contain their own set of challenges (e.g., Bullock, Green, & Ha, 2010). We describe types of experimental manipulations targeting the mediator (manipulations demonstrating a causal effect of the mediator on the dependent variable and manipulations targeting the strength of the causal effect of the mediator) and types of experimental designs (double randomization, concurrent double randomization, and parallel), provide published examples of the designs, and discuss the strengths and challenges of each design. Therefore, the goals of this paper include providing a practical guide to manipulation-of-mediator designs in light of their challenges and encouraging researchers to use more rigorous approaches to mediation because manipulation-of-mediator designs strengthen the ability to infer causality of the mediating variable on the dependent variable. PMID:27570259

Design approaches to experimental mediation.

PubMed

Pirlott, Angela G; MacKinnon, David P

2016-09-01

Identifying causal mechanisms has become a cornerstone of experimental social psychology, and editors in top social psychology journals champion the use of mediation methods, particularly innovative ones when possible (e.g. Halberstadt, 2010, Smith, 2012). Commonly, studies in experimental social psychology randomly assign participants to levels of the independent variable and measure the mediating and dependent variables, and the mediator is assumed to causally affect the dependent variable. However, participants are not randomly assigned to levels of the mediating variable(s), i.e., the relationship between the mediating and dependent variables is correlational. Although researchers likely know that correlational studies pose a risk of confounding, this problem seems forgotten when thinking about experimental designs randomly assigning participants to levels of the independent variable and measuring the mediator (i.e., "measurement-of-mediation" designs). Experimentally manipulating the mediator provides an approach to solving these problems, yet these methods contain their own set of challenges (e.g., Bullock, Green, & Ha, 2010). We describe types of experimental manipulations targeting the mediator (manipulations demonstrating a causal effect of the mediator on the dependent variable and manipulations targeting the strength of the causal effect of the mediator) and types of experimental designs (double randomization, concurrent double randomization, and parallel), provide published examples of the designs, and discuss the strengths and challenges of each design. Therefore, the goals of this paper include providing a practical guide to manipulation-of-mediator designs in light of their challenges and encouraging researchers to use more rigorous approaches to mediation because manipulation-of-mediator designs strengthen the ability to infer causality of the mediating variable on the dependent variable.

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

ERIC Educational Resources Information Center

Korat, O.; Shamir, A.

2008-01-01

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

The Effects of a STEM Professional Development Intervention on Elementary Teachers' Science Process Skills

ERIC Educational Resources Information Center

Cotabish, Alicia; Dailey, Deborah; Hughes, Gail D.; Robinson, Ann

2011-01-01

In order to increase the quality and quantity of science instruction, elementary teachers must receive professional development in science learning processes. The current study was part of a larger randomized field study of teacher and student learning in science. In two districts in a southern state, researchers randomly assigned teacher…

A Randomized Trial of Brief Interventions for Problem and Pathological Gamblers

ERIC Educational Resources Information Center

Petry, Nancy M.; Weinstock, Jeremiah; Ledgerwood, David M.; Morasco, Benjamin

2008-01-01

Limited research exists regarding methods for reducing problem gambling. Problem gamblers (N = 180) were randomly assigned to assessment only control, 10 min of brief advice, 1 session of motivational enhancement therapy (MET), or 1 session of MET plus 3 sessions of cognitive-behavioral therapy. Gambling was assessed at baseline, at 6 weeks, and…

Big Math for Little Kids: The Effectiveness of a Preschool and Kindergarten Mathematics Curriculum

ERIC Educational Resources Information Center

Lewis Presser, Ashley; Clements, Margaret; Ginsburg, Herbert; Ertle, Barbrina

2015-01-01

Research Findings: Big Math for Little Kids (BMLK) is a mathematics curriculum developed for use with 4- and 5-year-old children. To investigate the BMLK curriculum's effect on children's mathematics knowledge, this cluster-randomized controlled trial randomly assigned child care centers to provide mathematics instruction to children, using either…

WWC Review of the Report "Same-Language-Subtitling (SLS): Using Subtitled Music Video for Reading Growth". What Works Clearinghouse Single Study Review

ERIC Educational Resources Information Center

What Works Clearinghouse, 2013

2013-01-01

This randomized controlled trial examined the impacts of "Same-Language-Subtitling" ("SLS"), a karaoke-style subtitling intervention, on the reading comprehension skills of secondary school students in Kaneohe, Hawaii. Researchers randomly assigned 198 secondary school students with learning disabilities (ages 14 to 19) to…

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

ERIC Educational Resources Information Center

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

2014-01-01

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

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

PubMed

NeCamp, Timothy; Kilbourne, Amy; Almirall, Daniel

2017-08-01

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

Experimental Evaluation of the Effects of a Research-Based Preschool Mathematics Curriculum

ERIC Educational Resources Information Center

Clements, Douglas H.; Sarama, Julie

2008-01-01

A randomized-trials design was used to evaluate the effectiveness of a preschool mathematics program based on a comprehensive model of research-based curricula development. Thirty-six preschool classrooms were assigned to experimental (Building Blocks), comparison (a different preschool mathematics curriculum), or control conditions. Children were…

Interrupted Time Series Analysis: A Research Technique for Evaluating Social Programs for the Elderly

ERIC Educational Resources Information Center

Calsyn, Robert J.; And Others

1977-01-01

After arguing that treatment programs for the elderly need to be evaluated with better research designs, the authors illustrate how interrupted time series analysis can be used to evaluate programs for the elderly when random assignment to experimental and control groups is not possible. (Author)

A Program to Improve Student Engagement at Research-Focused Universities

ERIC Educational Resources Information Center

Whillans, Ashley V.; Hope, Sally E.; Wylie, Lauren J.; Zhao, Bob; Souza, Michael J.

2018-01-01

Promoting undergraduate engagement is an important and challenging obstacle at large research-focused universities. Thus, the current study evaluated whether a peer-led program of student-geared events could improve engagement among a diverse group of psychology students early on in their degrees. We randomly assigned interested second-year…

Optimal Design for Two-Level Random Assignment and Regression Discontinuity Studies

ERIC Educational Resources Information Center

Rhoads, Christopher H.; Dye, Charles

2016-01-01

An important concern when planning research studies is to obtain maximum precision of an estimate of a treatment effect given a budget constraint. When research designs have a "multilevel" or "hierarchical" structure changes in sample size at different levels of the design will impact precision differently. Furthermore, there…

A Randomized Trial of Motivational Interviewing to Improve Middle School Students' Academic Performance

ERIC Educational Resources Information Center

Strait, Gerald Gill; Smith, Bradley H.; McQuillin, Sam; Terry, John; Swan, Suzanne; Malone, Patrick S.

2012-01-01

Motivational interviewing (MI) is an effective method of promoting change in adults, but research on adolescents is limited. This study tests the efficacy of MI for promoting academic achievement in middle school students. Participants were 103 6th-, 7th-, and 8th-grade students randomly assigned to either a MI (n = 50) or a waitlist control…

Longitudinal Evaluation of a Scale-up Model for Teaching Mathematics with Trajectories and Technologies: Persistence of Effects in the Third Year

ERIC Educational Resources Information Center

Clements, Douglas H.; Sarama, Julie; Wolfe, Christopher B.; Spitler, Mary Elaine

2013-01-01

Using a cluster randomized trial design, we evaluated the persistence of effects of a research-based model for scaling up educational interventions. The model was implemented in 42 schools in two city districts serving low-resource communities, randomly assigned to three conditions. In pre-kindergarten, the two experimental interventions were…

Preference in Random Assignment: Implications for the Interpretation of Randomized Trials

PubMed Central

Gold, Paul B.; Hargreaves, William A.; Aronson, Elliot; Bickman, Leonard; Barreira, Paul J.; Jones, Danson R.; Rodican, Charles F.; Fisher, William H.

2009-01-01

Random assignment to a preferred experimental condition can increase service engagement and enhance outcomes, while assignment to a less-preferred condition can discourage service receipt and limit outcome attainment. We examined randomized trials for one prominent psychiatric rehabilitation intervention, supported employment, to gauge how often assignment preference might have complicated the interpretation of findings. Condition descriptions, and greater early attrition from services-as-usual comparison conditions, suggest that many study enrollees favored assignment to new rapid-job-placement supported employment, but no study took this possibility into account. Reviews of trials in other service fields are needed to determine whether this design problem is widespread. PMID:19434489

"Congratulations, you have been randomized into the control group!(?)": issues to consider when recruiting schools for matched-pair randomized control trials of prevention programs.

PubMed

Ji, Peter; DuBois, David L; Flay, Brian R; Brechling, Vanessa

2008-03-01

Recruiting schools into a matched-pair randomized control trial (MP-RCT) to evaluate the efficacy of a school-level prevention program presents challenges for researchers. We considered which of 2 procedures would be most effective for recruiting schools into the study and assigning them to conditions. In 1 procedure (recruit and match/randomize), we would recruit schools and match them prior to randomization, and in the other (match/randomize and recruitment), we would match schools and randomize them prior to recruitment. We considered how each procedure impacted the randomization process and our ability to recruit schools into the study. After implementing the selected procedure, the equivalence of both treatment and control group schools and the participating and nonparticipating schools on school demographic variables was evaluated. We decided on the recruit and match/randomize procedure because we thought it would provide the opportunity to build rapport with the schools and prepare them for the randomization process, thereby increasing the likelihood that they would accept their randomly assigned conditions. Neither the treatment and control group schools nor the participating and nonparticipating schools exhibited statistically significant differences from each other on any of the school demographic variables. Recruitment of schools prior to matching and randomization in an MP-RCT may facilitate the recruitment of schools and thus enhance both the statistical power and the representativeness of study findings. Future research would benefit from the consideration of a broader range of variables (eg, readiness to implement a comprehensive prevention program) both in matching schools and in evaluating their representativeness to nonparticipating schools.

Short-Term-Effectiveness of a Relationship Education Program for Distressed Military Couples, in the Context of Foreign Assignments for the German Armed Forces. Preliminary Findings From a Randomized Controlled Study.

PubMed

Kröger, Christoph; Kliem, Sören; Zimmermann, Peter; Kowalski, Jens

2018-04-01

This study examines the short-term effectiveness of a relationship education program designed for military couples. Distressed couples were randomly placed in either a wait-list control group or an intervention group. We conducted training sessions before a 3-month foreign assignment, and refresher courses approximately 6-week post-assignment. We analyzed the dyadic data of 32 couples, using hierarchical linear modeling in a two-level model. Reduction in unresolved conflicts was found in the intervention group, with large pre-post effects for both partners. Relationship satisfaction scores were improved, with moderate-to-large effects only for soldiers, rather than their partners. Post-follow-up effect sizes suggested further improvement in the intervention group. Future research should examine the long-term effectiveness of this treatment. © 2017 American Association for Marriage and Family Therapy.

Separating boys and girls and increasing weight? Assessing the impacts of single-sex schools through random assignment in Seoul

PubMed Central

Choi, Jaesung; Park, Hyunjoon; Behrman, Jere R.

2015-01-01

A growing body of research reports associations of school contexts with adolescents’ weight and weight-related behaviors. One interesting, but under-researched, dimension of school context that potentially matters for adolescents’ weight is the gender composition. If boys and girls are separated into single-sex schools, they might be less concerned about physical appearance, which may result in increased weight. Utilizing a unique setting in Seoul, Korea where students are randomly assigned to single-sex and coeducational schools within school districts, we estimate causal effects of single-sex schools on weight and weight-related behaviors. Our results show that students attending single-sex schools are more likely to be overweight, and that the effects are more pronounced for girls. We also find that girls in single-sex schools are less likely to engage in strenuous activities than their coeducational counterparts. PMID:25863424

Separating boys and girls and increasing weight? Assessing the impacts of single-sex schools through random assignment in Seoul.

PubMed

Choi, Jaesung; Park, Hyunjoon; Behrman, Jere R

2015-06-01

A growing body of research reports associations of school contexts with adolescents' weight and weight-related behaviors. One interesting, but under-researched, dimension of school context that potentially matters for adolescents' weight is the gender composition. If boys and girls are separated into single-sex schools, they might be less concerned about physical appearance, which may result in increased weight. Utilizing a unique setting in Seoul, Korea where students are randomly assigned to single-sex and coeducational schools within school districts, we estimate causal effects of single-sex schools on weight and weight-related behaviors. Our results show that students attending single-sex schools are more likely to be overweight, and that the effects are more pronounced for girls. We also find that girls in single-sex schools are less likely to engage in strenuous activities than their coeducational counterparts. Copyright © 2015 Elsevier Ltd. All rights reserved.

Randomized controlled trials in evidence-based mental health care: getting the right answer to the right question.

PubMed

Essock, Susan M; Drake, Robert E; Frank, Richard G; McGuire, Thomas G

2003-01-01

The purpose of clinical research is to answer this question: Would a new treatment, when added to the existing range of treatment options available in practice, help patients? Randomized controlled trials (RCTs)--in particular, double-blind RCTs--have important methodological advantages over observational studies for addressing this question. These advantages, however, come at a price. RCTs compare treatments using a particular allocation rule for assigning patients to treatments (random assignment) that does not mimic real-world practice. "Favorable" results from an RCT indicating that a new treatment is superior to existing treatments are neither necessary nor sufficient for establishing a "yes" answer to the question posed above. Modeled on an experimental design, RCTs are expensive in time and money and must compare simple differences in treatments. Findings have a high internal validity but may not address the needs of the field, particularly where treatment is complex and rapidly evolving. Design of clinical research needs to take account of the way treatments are allocated in actual practice and include flexible designs to answer important questions most effectively.

The Effects of Scenario Planning on Participant Reports of Resilience

ERIC Educational Resources Information Center

Chermack, Thomas J.; Coons, Laura M.; O'barr, Gregory; Khatami, Shiva

2017-01-01

Purpose: The purpose of this research is to examine the effects of scenario planning on participant ratings of resilience. Design/methodology/approach: The research design is a quasi experimental pretest/posttest with treatment and control groups. Random selection or assignment was not achieved. Findings: Results show a significant difference in…

The Influence of Small Class Size, Duration, Intensity, and Heterogeneity on Head Start Fade

ERIC Educational Resources Information Center

Huss, Christopher D.

2010-01-01

The researcher conducted a nonexperimental study to investigate and analyze the influence of reduced class sizes, intensity (all day and every day), duration (five years), and heterogeneity (random class assignment) on the Head Start Fade effect. The researcher employed retrospective data analysis using a longitudinal explanatory design on data…

Effects of Early Writing Intervention Delivered within a Data-Based Instruction Framework

ERIC Educational Resources Information Center

Jung, Pyung-Gang; McMaster, Kristen L.; delMas, Robert C.

2017-01-01

We examined effects of research-based early writing intervention delivered within a data-based instruction (DBI) framework for children with intensive needs. We randomly assigned 46 students with and without disabilities in Grades 1 to 3 within classrooms to either treatment or control. Treatment students received research-based early writing…

Educational Research with Real-World Data: Reducing Selection Bias with Propensity Scores

ERIC Educational Resources Information Center

Adelson, Jill L.

2013-01-01

Often it is infeasible or unethical to use random assignment in educational settings to study important constructs and questions. Hence, educational research often uses observational data, such as large-scale secondary data sets and state and school district data, and quasi-experimental designs. One method of reducing selection bias in estimations…

A Course on Effective Teacher-Child Interactions. Research Brief

ERIC Educational Resources Information Center

Hamre, Bridget K.; Pianta, Robert C.; Burchinal, Margaret; Field, Samuel; LoCasale-Crouch, Jennifer; Downer, Jason T.; Howes, Carollee; LaParo, Karen; Scott-Little, Catherine

2012-01-01

This study found that teachers who were randomly assigned to take a 14-week course on effective teacher-child interactions demonstrated significant changes in beliefs and knowledge about effective practices and provided more stimulating and engaging interactions in the classroom. [This research brief is based on: Hamre, B. K., Pianta, R. C.,…

Attrition Standard. WWC Standards Brief

ERIC Educational Resources Information Center

What Works Clearinghouse, 2017

2017-01-01

"Attrition" is the loss of sample during the course of a study. It occurs when individuals initially randomly assigned in a study are not included when researchers examine the outcome of interest. Attrition is a common issue in education research, and it occurs for many reasons. The What Works Clearinghouse (WWC) is an initiative of the…

A Randomized Controlled Trial to Evaluate Outcomes of a Workplace Self-Management Intervention and an Intensive Monitoring Intervention

ERIC Educational Resources Information Center

Schopp, Laura H.; Clark, Mary J.; Lamberson, William R.; Uhr, David J.; Minor, Marian A.

2017-01-01

The purpose of this study was to determine and compare outcomes of two voluntary workplace health management methods: an adapted worksite self-management (WSM) approach and an intensive health monitoring (IM) approach. Research participants were randomly assigned to either the WSM group or the IM group by a computer-generated list (n = 180; 92 WSM…

Can Nonexperimental Estimates Replicate Estimates Based on Random Assignment in Evaluations of School Choice? A Within-Study Comparison

ERIC Educational Resources Information Center

Bifulco, Robert

2012-01-01

The ability of nonexperimental estimators to match impact estimates derived from random assignment is examined using data from the evaluation of two interdistrict magnet schools. As in previous within-study comparisons, nonexperimental estimates differ from estimates based on random assignment when nonexperimental estimators are implemented…

76 FR 43729 - Notice of Random Assignment Study To Evaluate Workforce Investment Act Adult and Dislocated...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-21

... DEPARTMENT OF LABOR Employment and Training Administration Notice of Random Assignment Study To... interest to use a random assignment impact methodology for the study. In the local workforce investment... study during a 12-18 month period. The Department is soliciting comments concerning the Department's...

Non-manipulation quantitative designs.

PubMed

Rumrill, Phillip D

2004-01-01

The article describes non-manipulation quantitative designs of two types, correlational and causal comparative studies. Both of these designs are characterized by the absence of random assignment of research participants to conditions or groups and non-manipulation of the independent variable. Without random selection or manipulation of the independent variable, no attempt is made to draw causal inferences regarding relationships between independent and dependent variables. Nonetheless, non-manipulation studies play an important role in rehabilitation research, as described in this article. Examples from the contemporary rehabilitation literature are included. Copyright 2004 IOS Press

Telephone-Delivered Cognitive Behavioral Therapy for Chronic Pain Following Traumatic Brain Injury

DTIC Science & Technology

2013-10-01

ORGANIZATION NAME(S) AND ADDRESS(ES) University of Washington, Seattle, WA 98195 4333 AND ADDRESS(ES) 8 . PERFORMING ORGANIZATION REPORT...Medical Research and Materiel Command (USAMRMC) Office of Research Protections (ORP) Human Research Protections Office (HRPO) on August 8 , 2013... 8 subjects per month with recruitment and enrollment planned to start in Month 14. Study personnel will also commence random assignment of subjects

DIFFERENTIAL PATIENT RESPONSE TO INSTRUCTION, COUNSELING, AND DENTAL TREATMENT. PAPER PRESENTED AT A NATIONAL SEMINAR ON ADULT EDUCATION RESEARCH (CHICAGO, FEBRUARY 11-13, 1968).

ERIC Educational Resources Information Center

LUPTON, DANIEL E.

RESEARCH (1) ANALYZED SPECIFIC OUTCOMES OF COUNSELING, INSTRUCTION, AND DENTAL THERAPY, AND (2) DETERMINED THE RELATIVE EFFECTIVENESS OF PATIENT EDUCATION FOR RELIEF OF TEMPOROMANDIBULAR JOINT (TMJ) DYSFUNCTION. SIXTY ADULT PATIENTS ATTENDING THE UNIVERSITY OF ILLINOIS TMJ RESEARCH CENTER WERE RANDOMLY ASSIGNED TO ONE OF THREE PROGRAMS--DENTISTRY,…

78 FR 2418 - Privacy Act; Notification of New Privacy Act System of Records, Pre-Purchase Homeownership...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-11

... and Research (PD&R) and its contractors to conduct a random assignment and impact evaluation study of... ``Purpose'' section to obtain detailed information about the purpose of this study. DATES: Effective Date...

Researching Sex Bias in the Classroom.

ERIC Educational Resources Information Center

Donlan, Dan

This paper outlines five methods of research on sex bias in the classroom: one-time survey, one class/one treatment, two class/two treatment, one class/random assignment to treatment, and analysis of differentiated effect. It shows how each method could be used in attempting to measure the effect of a unit on Norma Klein's "Mom, the Wolfman and…

Estimating the Impact of the PROMISE Scholarship Using Propensity Score Weighted Frontier Fuzzy Regression Discontinuity Design

ERIC Educational Resources Information Center

Shobo, Yetty; Wong, Jen D.; Bell, Angie

2014-01-01

Regression discontinuity (RD), an "as good as randomized," research design is increasingly prominent in education research in recent years; the design gets eligible quasi-experimental designs as close as possible to experimental designs by using a stated threshold on a continuous baseline variable to assign individuals to a…

Using Norm-Based Appeals to Increase Response Rates in Evaluation Research: A Field Experiment

ERIC Educational Resources Information Center

Misra, Shalini; Stokols, Daniel; Marino, Anne Heberger

2012-01-01

A field experiment was conducted to test the effectiveness of norm-based persuasive messages for increasing response rates in online survey research. Participants in an interdisciplinary conference were asked to complete two successive postconference surveys and randomly assigned to one of two groups at each time point. The experimental group…

Causal Inference and Omitted Variable Bias in Financial Aid Research: Assessing Solutions

ERIC Educational Resources Information Center

Riegg, Stephanie K.

2008-01-01

This article highlights the problem of omitted variable bias in research on the causal effect of financial aid on college-going. I first describe the problem of self-selection and the resulting bias from omitted variables. I then assess and explore the strengths and weaknesses of random assignment, multivariate regression, proxy variables, fixed…

Successfully Promoting 21st Century Online Research Skills: Interventions in 5th-Grade Classrooms

ERIC Educational Resources Information Center

Kingsley, Tara L.; Cassady, Jerrell C.; Tancock, Susan M.

2015-01-01

This quantitative study was developed to explore the ability to impact elementary student 21st Century online research skills with a planned classroom intervention curriculum. The repeated measures quasi-experimental study randomly assigned all 5th grade classes in a Midwestern, suburban school (n = 418) to a 12-week intervention or control…

Safety of 6-month duration of dual antiplatelet therapy after percutaneous coronary intervention in patients with acute coronary syndromes: Rationale and design of the Smart Angioplasty Research Team-safety of 6-month duration of Dual Antiplatelet Therapy after percutaneous coronary intervention in patients with acute coronary syndromes (SMART-DATE) prospective multicenter randomized trial.

PubMed

Lee, Joo Myung; Cho, Deok-Kyu; Hahn, Joo-Yong; Song, Young Bin; Park, Taek Kyu; Oh, Ju-Hyeon; Lee, Jin Bae; Doh, Joon-Hyung; Kim, Sang-Hyun; Yang, Jeong Hoon; Choi, Jin-Ho; Choi, Seung-Hyuck; Lee, Sang Hoon; Gwon, Hyeon-Cheol

2016-12-01

Dual antiplatelet therapy (DAPT) is a fundamental treatment that optimizes clinical outcomes after percutaneous coronary intervention, especially in patients with acute coronary syndrome (ACS). Although current international guidelines recommend DAPT for at least 12 months after implantation of a drug-eluting stent in patients with ACS, these recommendations are not based on randomized controlled trials dedicated to ACS population. The SMART-DATE trial is a prospective, multicenter, randomized, and open-label study to demonstrate the noninferiority of 6-month DAPT compared with 12 months or longer DAPT in patients with ACS undergoing percutaneous coronary intervention. A total of 2,700 patients will undergo prospective, random assignment to either of the DAPT duration groups. To minimize the bias from different stent devices, the type of stents will be randomly assigned (everolimus-eluting stents, zotarolimus-eluting stents, or biolimus A9-eluting stents). The primary end point is a composite of all-cause death, myocardial infarction, and cerebrovascular events at 18 months after the index procedure. The major secondary end points are definite/probable stent thrombosis defined by the Academic Research Consortium and bleeding defined by Bleeding Academic Research Consortium type 2-5. The SMART-DATE randomized trial is the first study exploring the safety of 6-month DAPT compared with conventional 12-month or longer DAPT dedicated to patients with ACS after second-generation drug-eluting stent implantation. Copyright © 2016 Elsevier Inc. All rights reserved.

Power Calculations for Moderators in Multi-Site Cluster Randomized Trials

ERIC Educational Resources Information Center

Spybrook, Jessaca; Kelcey, Ben; Dong, Nianbo

2016-01-01

Cluster randomized trials (CRTs), or studies in which intact groups of individuals are randomly assigned to a condition, are becoming more common in evaluation studies of educational programs. A specific type of CRT in which clusters are randomly assigned to treatment within blocks or sites, known as multisite cluster randomized trials (MSCRTs),…

Improved outcome with pulses of vincristine and corticosteroids in continuation therapy of children with average risk acute lymphoblastic leukemia (ALL) and lymphoblastic non-Hodgkin lymphoma (NHL): report of the EORTC randomized phase 3 trial 58951.

PubMed

De Moerloose, Barbara; Suciu, Stefan; Bertrand, Yves; Mazingue, Françoise; Robert, Alain; Uyttebroeck, Anne; Yakouben, Karima; Ferster, Alice; Margueritte, Geneviève; Lutz, Patrick; Munzer, Martine; Sirvent, Nicolas; Norton, Lucilia; Boutard, Patrick; Plantaz, Dominique; Millot, Frederic; Philippet, Pierre; Baila, Liliana; Benoit, Yves; Otten, Jacques

2010-07-08

The European Organisation for Research and Treatment of Cancer 58951 trial for children with acute lymphoblastic leukemia (ALL) or non-Hodgkin lymphoma (NHL) addressed 3 randomized questions, including the evaluation of dexamethasone (DEX) versus prednisolone (PRED) in induction and, for average-risk patients, the evaluation of vincristine and corticosteroid pulses during continuation therapy. The corticosteroid used in the pulses was that assigned at induction. Overall, 411 patients were randomly assigned: 202 initially randomly assigned to PRED (60 mg/m(2)/d), 201 to DEX (6 mg/m(2)/d), and 8 nonrandomly assigned to PRED. At a median follow-up of 6.3 years, there were 19 versus 34 events for pulses versus no pulses; 6-year disease-free survival (DFS) rate was 90.6% (standard error [SE], 2.1%) and 82.8% (SE, 2.8%), respectively (hazard ratio [HR] = 0.54; 95% confidence interval, 0.31-0.94; P = .027). The effect of pulses was similar in the PRED (HR = 0.56) and DEX groups (HR = 0.59) but more pronounced in girls (HR = 0.24) than in boys (HR = 0.71). Grade 3 to 4 hepatic toxicity was 30% versus 40% in pulses versus no pulses group and grade 2 to 3 osteonecrosis was 4.4% versus 2%. For average-risk patients treated according to Berlin-Frankfurt-Muenster-based protocols, pulses should become a standard component of therapy.

Randomization in clinical trials in orthodontics: its significance in research design and methods to achieve it.

PubMed

Pandis, Nikolaos; Polychronopoulou, Argy; Eliades, Theodore

2011-12-01

Randomization is a key step in reducing selection bias during the treatment allocation phase in randomized clinical trials. The process of randomization follows specific steps, which include generation of the randomization list, allocation concealment, and implementation of randomization. The phenomenon in the dental and orthodontic literature of characterizing treatment allocation as random is frequent; however, often the randomization procedures followed are not appropriate. Randomization methods assign, at random, treatment to the trial arms without foreknowledge of allocation by either the participants or the investigators thus reducing selection bias. Randomization entails generation of random allocation, allocation concealment, and the actual methodology of implementing treatment allocation randomly and unpredictably. Most popular randomization methods include some form of restricted and/or stratified randomization. This article introduces the reasons, which make randomization an integral part of solid clinical trial methodology, and presents the main randomization schemes applicable to clinical trials in orthodontics.

Nasogastric hydration versus intravenous hydration for infants with bronchiolitis: a randomised trial.

PubMed

Oakley, Ed; Borland, Meredith; Neutze, Jocelyn; Acworth, Jason; Krieser, David; Dalziel, Stuart; Davidson, Andrew; Donath, Susan; Jachno, Kim; South, Mike; Theophilos, Theane; Babl, Franz E

2013-04-01

Bronchiolitis is the most common lower respiratory tract infection in infants and the leading cause of hospital admission. Hydration is a mainstay of treatment, but insufficient evidence exists to guide clinical practice. We aimed to assess whether intravenous hydration or nasogastric hydration is better for treatment of infants. In this multicentre, open, randomised trial, we enrolled infants aged 2-12 months admitted to hospitals in Australia and New Zealand with a clinical diagnosis of bronchiolitis during three bronchiolitis seasons (April 1-Oct 31, in 2009, 2010, and 2011). We randomly allocated infants to nasogastric hydration or intravenous hydration by use of a computer-generated sequence and opaque sealed envelopes, with three randomly assigned block sizes and stratified by hospital site and age group (2-<6 months vs 6-12 months). The primary outcome was length of hospital stay, assessed in all randomly assigned infants. Secondary outcomes included rates of intensive-care unit admission, adverse events, and success of insertion. This trial is registered with the Australian and New Zealand clinical trials registry, ACTRN12605000033640. Mean length of stay for 381 infants assigned nasogastric hydration was 86·6 h (SD 58·9) compared with 82·2 h (58·8) for 378 infants assigned intravenous hydration (absolute difference 4·5 h [95% CI -3·9 to 12·9]; p=0·30). Rates of admission to intensive-care units, need for ventilatory support, and adverse events did not differ between groups. At randomisation, seven infants assigned nasogastric hydration were switched to intravenous hydration and 56 infants assigned intravenous hydration were switched to nasogastric hydration because the study-assigned method was unable to be inserted. For those infants who had data available for successful insertion, 275 (85%) of 323 infants in the nasogastric hydration group and 165 (56%) of 294 infants in the intravenous hydration group required only one attempt for successful insertion. Intravenous hydration and nasogastric hydration are appropriate means to hydrate infants with bronchiolitis. Nasogastric insertion might require fewer attempts and have a higher success rate of insertion than intravenous hydration. Australian National Health and Medical Research Council, Samuel Nissen Charitable Foundation (Perpetual), Murdoch Children's Research Institute, Victorian Government. Copyright © 2013 Elsevier Ltd. All rights reserved.

Effects of Choice on Intervention Outcomes for College Students Sanctioned for Campus Alcohol Policy Violations

PubMed Central

Carey, Kate B.; DeMartini, Kelly S.; Prince, Mark A.; Luteran, Carrie; Carey, Michael P.

2012-01-01

This study tested the hypothesis that client choice influences intervention outcomes. We recruited 288 student drinkers (60% male, 67% freshmen) required to participate in an intervention due to a violation of campus alcohol policy. Participants were randomized either to self-chosen or researcher-assigned interventions. In the choice condition they selected either a brief motivational intervention (BMI) or a computer-delivered educational program. In the assigned condition they received one of the two interventions, assigned randomly. Follow-up assessments at 1- and 2-months revealed that choice was associated with higher intervention satisfaction. However, the assigned and choice conditions did not differentially change on consumption or consequences across intervention type. Overall, change scores favored the BMI over the computer-delivered intervention on consumption and consequences. Exploratory analyses revealed that, given the choice of intervention, heavier drinking students self-selected into the face-to-face BMI. Furthermore, among the students who received a BMI, the students who chose it (despite their heavier drinking) reduced drinks per drinking day more than the assigned students. In sum, offering a choice of intervention to students mandated for campus alcohol violations increased the chance that at-risk students will select a more intensive and effective intervention. PMID:23046274

Teen options for change: an intervention for young emergency patients who screen positive for suicide risk.

PubMed

King, Cheryl A; Gipson, Polly Y; Horwitz, Adam G; Opperman, Kiel J

2015-01-01

Previous research has documented the feasibility of screening in emergency departments for adolescent suicide risk. This randomized trial examined the effectiveness of Teen Options for Change (TOC), an intervention for adolescents seeking general medical emergency services who screen positive for suicide risk. Participants were 49 youths, ages 14 to 19, seeking services for nonpsychiatric emergencies. They screened positive for suicide risk because of recent suicidal ideation, suicide attempt, or depression plus substance abuse. Youths were randomly assigned to the TOC intervention or to enhanced treatment as usual. Depression, hopelessness, and suicidal ideation were assessed at baseline and two months later. Adolescents assigned to TOC showed greater reductions in depression than adolescents assigned to the comparison group (Cohen's d=1.07, a large effect size). Hopelessness, suicidal ideation, and substance abuse outcomes trended positively (nonsignificantly), with small to moderate effect sizes. TOC may be a promising, brief intervention for adolescents seeking emergency services and at risk of suicide.

An Empirical Comparison of Methods for Equating with Randomly Equivalent Groups of 50 to 400 Test Takers. Research Report. ETS RR-10-05

ERIC Educational Resources Information Center

Livingston, Samuel A.; Kim, Sooyeon

2010-01-01

A series of resampling studies investigated the accuracy of equating by four different methods in a random groups equating design with samples of 400, 200, 100, and 50 test takers taking each form. Six pairs of forms were constructed. Each pair was constructed by assigning items from an existing test taken by 9,000 or more test takers. The…

Birds of a Feather Bully Together: Group Processes and Children's Responses to Bullying

ERIC Educational Resources Information Center

Jones, Sian E.; Manstead, Antony S. R.; Livingstone, Andrew

2009-01-01

Recent research has shown that a group-level analysis can inform our understanding of school bullying. The present research drew on social identity theory and intergroup emotion theory. Nine- to eleven-year olds were randomly assigned to the same group as story characters who were described as engaging in bullying, as being bullied, or as neither…

Sexual Harassment Prevention Initiatives: Quantitative and Qualitative Approaches

DTIC Science & Technology

2010-10-28

design , and the time series with nonequivalent control group design . The experimental research approach will randomly assign participants...Leedy & Ormrod, 2005). According to Fife- Schaw (2006) there are three quasi-experimental designs : the nonequivalent control group design , the time...that have controlled and isolated variables. A specific quantitative approach available to the researcher is the use of surveys. Surveys, in

Application to graduate psychology programs by undergraduate students of color: the impact of a research training program.

PubMed

Hall, Gordon C Nagayama; Allard, Carolyn B

2009-07-01

The top 86 students were selected from a pool of approximately 400 applicants to a summer clinical psychology research training program for undergraduate students of color. Forty-three of the students were randomly assigned to 1 of 2 clinical psychology research training programs, and 43 were randomly assigned to a control condition without training. The multicultural version of the training program emphasized the cultural context of psychology in all areas of training, whereas cultural context was de-emphasized in the monocultural version of the program. Although the cultural content of the 2 training programs was effectively manipulated as indicated by a fidelity check by an outside expert, there were no significant differences between the effects of the 2 programs on the outcomes measured in this study. The primary differences in this study were between students who did versus those who did not participate in a training program. Sixty-five percent of the students who completed the multicultural training program applied to graduate schools in psychology, compared with 47% of those who completed the monocultural training program, and 31% of those in the control group. Participation in summer research training programs also increased self-perceptions of multicultural competence.

Online Mathematics Homework Increases Student Achievement

ERIC Educational Resources Information Center

Roschelle, Jeremy; Feng, Mingyu; Murphy, Robert F.; Mason, Craig A.

2016-01-01

In a randomized field trial with 2,850 seventh-grade mathematics students, we evaluated whether an educational technology intervention increased mathematics learning. Assigning homework is common yet sometimes controversial. Building on prior research on formative assessment and adaptive teaching, we predicted that combining an online homework…

B vitamins in patients with recent transient ischaemic attack or stroke in the VITAmins TO Prevent Stroke (VITATOPS) trial: a randomised, double-blind, parallel, placebo-controlled trial.

PubMed

2010-09-01

Epidemiological studies suggest that raised plasma concentrations of total homocysteine might be a risk factor for major vascular events. Whether lowering total homocysteine with B vitamins prevents major vascular events in patients with previous stroke or transient ischaemic attack is unknown. We aimed to assess whether the addition of once-daily supplements of B vitamins to usual medical care would lower total homocysteine and reduce the combined incidence of non-fatal stroke, non-fatal myocardial infarction, and death attributable to vascular causes in patients with recent stroke or transient ischaemic attack of the brain or eye. In this randomised, double-blind, parallel, placebo-controlled trial, we assigned patients with recent stroke or transient ischaemic attack (within the past 7 months) from 123 medical centres in 20 countries to receive one tablet daily of placebo or B vitamins (2 mg folic acid, 25 mg vitamin B6, and 0.5 mg vitamin B12). Patients were randomly allocated by means of a central 24-h telephone service or an interactive website, and allocation was by use of random permuted blocks stratified by hospital. Participants, clinicians, carers, and investigators who assessed outcomes were masked to the assigned intervention. The primary endpoint was the composite of stroke, myocardial infarction, or vascular death. All patients randomly allocated to a group were included in the analysis of the primary endpoint. This trial is registered with ClinicalTrials.gov, NCT00097669, and Current Controlled Trials, ISRCTN74743444. Between Nov 19, 1998, and Dec 31, 2008, 8164 patients were randomly assigned to receive B vitamins (n=4089) or placebo (n=4075). Patients were followed up for a median duration of 3.4 years (IQR 2.0-5.5). 616 (15%) patients assigned to B vitamins and 678 (17%) assigned to placebo reached the primary endpoint (risk ratio [RR] 0.91, 95% CI 0.82 to 1.00, p=0.05; absolute risk reduction 1.56%, -0.01 to 3.16). There were no unexpected serious adverse reactions and no significant differences in common adverse effects between the treatment groups. Daily administration of folic acid, vitamin B6, and vitamin B12 to patients with recent stroke or transient ischaemic attack was safe but did not seem to be more effective than placebo in reducing the incidence of major vascular events. These results do not support the use of B vitamins to prevent recurrent stroke. The results of ongoing trials and an individual patient data meta-analysis will add statistical power and precision to present estimates of the effect of B vitamins. Australia National Health and Medical Research Council, UK Medical Research Council, Singapore Biomedical Research Council, Singapore National Medical Research Council, Australia National Heart Foundation, Royal Perth Hospital Medical Research Foundation, and Health Department of Western Australia. Copyright 2010 Elsevier Ltd. All rights reserved.

Applications of random forest feature selection for fine-scale genetic population assignment.

PubMed

Sylvester, Emma V A; Bentzen, Paul; Bradbury, Ian R; Clément, Marie; Pearce, Jon; Horne, John; Beiko, Robert G

2018-02-01

Genetic population assignment used to inform wildlife management and conservation efforts requires panels of highly informative genetic markers and sensitive assignment tests. We explored the utility of machine-learning algorithms (random forest, regularized random forest and guided regularized random forest) compared with F ST ranking for selection of single nucleotide polymorphisms (SNP) for fine-scale population assignment. We applied these methods to an unpublished SNP data set for Atlantic salmon ( Salmo salar ) and a published SNP data set for Alaskan Chinook salmon ( Oncorhynchus tshawytscha ). In each species, we identified the minimum panel size required to obtain a self-assignment accuracy of at least 90% using each method to create panels of 50-700 markers Panels of SNPs identified using random forest-based methods performed up to 7.8 and 11.2 percentage points better than F ST -selected panels of similar size for the Atlantic salmon and Chinook salmon data, respectively. Self-assignment accuracy ≥90% was obtained with panels of 670 and 384 SNPs for each data set, respectively, a level of accuracy never reached for these species using F ST -selected panels. Our results demonstrate a role for machine-learning approaches in marker selection across large genomic data sets to improve assignment for management and conservation of exploited populations.

Empirical Comparison of Two Psychological Therapies: Self Psychology and Cognitive Orientation in the Treatment of Anorexia and Bulimia

PubMed Central

Bachar, Eytan; Latzer, Yael; Kreitler, Shulamit; Berry, Elliot M.

1999-01-01

The authors investigated the applicability of self psychological treatment (SPT) and cognitive orientation treatment (COT) to the treatment of anorexia and bulimia. Thirty-three patients participated in this study. The bulimic patients (n = 25) were randomly assigned either to SPT, COT, or control/nutritional counseling only (C/NC). The anorexic patients (n = 8) were randomly assigned to either SPT or COT. Patients were administered a battery of outcome measures assessing eating disorders symptomatology, attitudes toward food, self structure, and general psychiatric symptoms. After SPT, significant improvement was observed. After COT, slight but nonsignificant improvement was observed. After C/NC, almost no changes could be detected.(The Journal of Psychotherapy Practice and Research 1999; 8:115–128) PMID:10079459

78 FR 24423 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-25

... an experimental research design. Program applicants who are eligible for CSPED services will be randomly assigned to either a program group that is offered program services or a control group that is not...) conducting focus groups with program participants to elicit participation experiences; (3) administering a...

Learned Helplessness in Exceptional Children.

ERIC Educational Resources Information Center

Brock, Herman B.; Kowitz, Gerald T.

The research literature on learned helplessness in exceptional children is reviewed and the authors' efforts to identify and retrain learning disabled (LD) children who have characteristics typical of learned helplessness are reported. Twenty-eight elementary aged LD children viewed as "learned helpless" were randomly assigned to one of four…

The role of community health workers (CHWs) in health promotion research: ethical challenges and practical solutions.

PubMed

Terpstra, Jennifer; Coleman, Karen J; Simon, Gayle; Nebeker, Camille

2011-01-01

This article aims to describe the role of community health workers (CHWs) in health promotion research and address the challenges and ethical concerns associated with this research approach. A series of six focus groups are conducted with project managers and investigators (n = 5 to 11 per session) who have worked with CHWs in health promotion research. These focus groups are part of a larger study funded by the National Institutes of Health titled "Training in Research Ethics and Standards" (Project TRES). Participants are asked to describe their training needs for CHWs with respect to human subject protections as well as to identify associated challenges regarding research practice (i.e., recruitment, random assignment, protocol implementation, etc.). Findings reveal a number of challenges that investigators and project managers encounter when working with CHWs on research projects involving the community. These include characteristics inherent to CHWs such as education level and personal beliefs about their own community and its needs, institutional regulations regarding research practice, and problems inherent to research studies such as training materials and protocols that cannot account for the complexity of conducting research in community settings. Investigators should carefully consider the role that CHWs have in their communities before creating research programs that depend on the CHWs' existing social networks and their propensity to be natural helpers. These strengths could lead to compromises in research requirements for random assignment, control groups, and fully informed consent.

Pain sensitivity and torque used during measurement predicts change in range of motion at the knee.

PubMed

Bishop, Mark D; George, Steven Z

2017-01-01

To determine the extent to which changes in knee range of motion (ROM) after a stretching program are related to sensory factors at the time of testing and the amount of force used during the measurement of ROM, rather than changes in soft-tissue properties. Randomized, single-blind design. Participants were randomly assigned to a control or stretching group. Research laboratory. Forty-four healthy volunteers (22.8±2.8 years of age; 23 men). The stretching group undertook static stretching twice a day for 8 weeks. The control group continued with routine activity, but was discouraged from starting a flexibility program. ROM and tissue extensibility was assessed using a Biodex3 dynamometer, and ratings of thermal pain were collected at baseline and at 4 and 8 weeks by an examiner blinded to group assignment. Multilevel modeling was used to examine predictors of ROM across time. The stretching group showed a 6% increase, and the control group had a 2% increase, in ROM over the 8-week program. However, when fixed and random effects were tested in a complete model, the group assignment was not significant. End-point torque during ROM testing ( p =0.021) and the ratings in response to thermal testing ( p <0.001) were significant, however. ROM measured in a testing session was not predicted by assignment to a stretching program. Rather, ROM was predicted by the ratings of thermal stimuli and the peak torque used to apply the stretch.

The effect of role assignment in high fidelity patient simulation on nursing students: An experimental research study.

PubMed

Weiler, Dustin T; Gibson, Andrea L; Saleem, Jason J

2018-04-01

Previous studies have evaluated the effectiveness of high fidelity patient simulators (HFPS) on nursing training; however, a gap exists on the effects of role assignment on critical thinking, self-efficacy, and situation awareness skills in team-based simulation scenarios. This study aims to determine if role assignment and the involvement level related to the roles yields significant effects and differences in critical thinking, situation awareness and self-efficacy scores in team-based high-fidelity simulation scenarios. A single factorial design with five levels and random assignment was utilized. A public university-sponsored simulation center in the United States of America. A convenience sample of 69 junior-level baccalaureate nursing students was recruited for participation. Participants were randomly assigned one of five possible roles and completed pre-simulation critical thinking and self-efficacy assessments prior to the simulation beginning. Playing within their assigned roles, participants experienced post-partum hemorrhaging scenario using an HFPS. After completing the simulation, participants completed a situation awareness assessment and a post-simulation critical thinking and self-efficacy assessment. Role assignment was found to have a statistically significant effect on critical thinking skills and a statistically significant difference in various areas of self-efficacy was also noted. However, no statistical significance in situation awareness abilities was found. Results support the notion that certain roles required the participant to be more involved with the simulation scenario, which may have yielded higher critical thinking and self-efficacy scores than roles that required a lesser level of involvement. Copyright © 2018 Elsevier Ltd. All rights reserved.

Blocking for Sequential Political Experiments

PubMed Central

Moore, Sally A.

2013-01-01

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

The Effects of Teaching Notetaking Strategies on Elementary Students' Science Learning

ERIC Educational Resources Information Center

Lee, Pai-Lin; Lan, William; Hamman, Douglas; Hendricks, Bret

2008-01-01

The research examined effects of notetaking instruction on elementary-aged students' abilities to recall science information and their notetaking behaviors. Classes of eight to nine years old third grade students were randomly assigned to three treatment conditions: strategic notetaking, partial strategic notetaking, and control, for four training…

Developing a Rubric to Assess Student Learning Outcomes Using a Class Assignment

ERIC Educational Resources Information Center

Thaler, Nicholas; Kazemi, Ellie; Huscher, Crystal

2009-01-01

We developed a rubric to assess several of our department's undergraduate student learning outcomes (SLOs). Target SLOs include applications of principles of research methodology, using appropriate statistics, adherence to the Publication Manual of the American Psychological Association, and written communication skills. We randomly sampled 20…

Due Process in Appraisal: A Quasi-Experiment in Procedural Justice.

ERIC Educational Resources Information Center

Taylor, M. Susan; And Others

1995-01-01

Extended research on procedural justice by examining effects of a due-process performance-appraisal system on (government) employees' and managers' reactions. Employee-management pairs were randomly assigned to either a due-process appraisal system or the existing one. Although due-process employees received lower evaluations, both employees and…

$320,000 Kindergarten Teachers

ERIC Educational Resources Information Center

Chetty, Raj; Friedman, John N.; Hilger, Nathaniel; Saez, Emmanuel; Schanzenbach, Diane Whitmore; Yagan, Danny

2010-01-01

In Project STAR, 11,571 students in Tennessee and their teachers were randomly assigned to different classrooms in their schools from kindergarten to 3rd grade. Researchers learned that kindergarten test scores are highly correlated with such outcomes as earnings at age 27, college attendance, home ownership, and retirement savings. Students who…

The Effect of Electronic Storybooks on Struggling Fourth-Graders' Reading Comprehension

ERIC Educational Resources Information Center

Ertem, Ihsan Seyit

2010-01-01

This quantitative research examined the differences in struggling readers' comprehension of storybooks according to the medium of presentation. Each student was randomly assigned with one of three conditions: (1) computer presentation of storybooks with animation; (2) computer presentation of storybooks without animation; and (3) traditional print…

Leader Positivity and Follower Creativity: An Experimental Analysis

ERIC Educational Resources Information Center

Avey, James B.; Richmond, F. Lynn; Nixon, Don R.

2012-01-01

Using an experimental research design, 191 working adults were randomly assigned to two experimental conditions in order to test a theoretical model linking leader and follower positive psychological capital (PsyCap). Multiple methods were used to gather information from the participants. We found when leader PsyCap was manipulated experimentally,…

Estimating Acceptability of Financial Health Incentives

ERIC Educational Resources Information Center

Bigsby, Elisabeth; Seitz, Holli H.; Halpern, Scott D.; Volpp, Kevin; Cappella, Joseph N.

2017-01-01

A growing body of evidence suggests that financial incentives can influence health behavior change, but research on the public acceptability of these programs and factors that predict public support have been limited. A representative sample of U.S. adults (N = 526) were randomly assigned to receive an incentive program description in which the…

Empirically Driven Variable Selection for the Estimation of Causal Effects with Observational Data

ERIC Educational Resources Information Center

Keller, Bryan; Chen, Jianshen

2016-01-01

Observational studies are common in educational research, where subjects self-select or are otherwise non-randomly assigned to different interventions (e.g., educational programs, grade retention, special education). Unbiased estimation of a causal effect with observational data depends crucially on the assumption of ignorability, which specifies…

Essays on Policy Evaluation with Endogenous Adoption

ERIC Educational Resources Information Center

Gentile, Elisabetta

2011-01-01

Over the last decade, experimental and quasi-experimental methods have been favored by researchers in empirical economics, as they provide unbiased causal estimates. However, when implementing a program, it is often not possible to randomly assign subjects to treatment, leading to a possible endogeneity bias. This dissertation consists of two…

Impacts of Professional Development in Classroom Assessment on Teacher and Student Outcomes

ERIC Educational Resources Information Center

Randel, Bruce; Apthorp, Helen; Beesley, Andrea D.; Clark, Tedra F.; Wang, Xin

2016-01-01

The authors describe an impact study of Classroom Assessment for Student Learning (CASL), a widely used professional development program in classroom and formative assessment. Researchers randomly assigned 67 elementary schools to receive CASL materials or continue with regularly scheduled professional development. Teachers in CASL schools formed…

Validation of a Supplemental Reading Intervention for First-Grade Children

ERIC Educational Resources Information Center

Case, Lisa Pericola; Speece, Deborah L.; Silverman, Rebecca; Ritchey, Kristen D.; Schatschneider, Christopher; Cooper, David H.; Montanaro, Elizabeth; Jacobs, Dawn

2010-01-01

This experimental study was designed to validate a short-term supplemental reading intervention for at-risk first-grade children. Although substantial research on long-term supplemental reading interventions exists, less is known about short-term interventions. Thirty first-grade children were randomly assigned to intervention or control…

Iowa Case Management for Rural Drug Abuse

ERIC Educational Resources Information Center

Hall, James A.; Vaughan Sarrazin, Mary S.; Huber, Diane L.; Vaughn, Thomas; Block, Robert I.; Reedy, Amanda R.; Jang, MiJin

2009-01-01

Objective: The purpose of this research was to evaluate the effectiveness of a comprehensive, strengths-based model of case management for clients in drug abuse treatment. Method: 503 volunteers from residential or intensive outpatient treatment were randomly assigned to one of three conditions of Iowa Case Management (ICM) plus treatment as usual…

Supervisor Attachment, Supervisory Working Alliance, and Affect in Social Work Field Instruction

ERIC Educational Resources Information Center

Bennett, Susanne; Mohr, Jonathan; Deal, Kathleen Holtz; Hwang, Jeongha

2013-01-01

Objective: This study focused on interrelationships among supervisor attachment, supervisory working alliance, and supervision-related affect, plus the moderating effect of a field instructor training. Method: The researchers employed a pretest-posttest follow-up design of 100 randomly assigned field instructors and 64 students in two…

The Red Effect, Anxiety, and Exam Performance: A Multistudy Examination

ERIC Educational Resources Information Center

Smajic, Adnan; Merritt, Stephanie; Banister, Christina; Blinebry, Amanda

2014-01-01

Laboratory studies have established a negative relationship between the color red and academic performance. This research examined whether this effect would generalize to classroom performance and whether anxiety and negative affect might mediate the effect. In two studies, students taking classroom exams were randomly assigned an exam color. We…

Teaching High-Expectation Strategies to Teachers through an Intervention Process

ERIC Educational Resources Information Center

McDonald, Lyn; Flint, Annaline; Rubie-Davies, Christine M.; Peterson, Elizabeth R.; Watson, Penny; Garrett, Lynda

2016-01-01

This study describes the outcomes of an intervention focused on the strategies and practices of high-expectation teachers. Specifically, the intervention involved 84 teachers who were randomly assigned to control and intervention groups. The research methodology was primarily qualitative, grounded in the interpretive tradition. Data collected from…

Optimal Design for Regression Discontinuity Studies with Clustering

ERIC Educational Resources Information Center

Rhoads, Christopher; Dye, Charles

2014-01-01

Recent years have seen an increased interest in quantitative educational research studies that use random assignment (RA) to evaluate the causal impacts of educational interventions (Angrist, 2004). The multi-level structure of the public education system in the United States often leads to experimental designs where naturally occurring clusters…

Optimizing the Scientific Yield from a Randomized Controlled Trial (RCT): Evaluating Two Behavioral Interventions and Assessment Reactivity with a Single Trial

PubMed Central

Carey, Michael P.; Senn, Theresa E.; Coury-Doniger, Patricia; Urban, Marguerite A.; Vanable, Peter A.; Carey, Kate B.

2013-01-01

Randomized controlled trials (RCTs) remain the gold standard for evaluating intervention efficacy but are often costly. To optimize their scientific yield, RCTs can be designed to investigate multiple research questions. This paper describes an RCT that used a modified Solomon four-group design to simultaneously evaluate two, theoretically-guided, health promotion interventions as well as assessment reactivity. Recruited participants (N = 1010; 56% male; 69% African American) were randomly assigned to one of four conditions formed by crossing two intervention conditions (i.e., general health promotion vs. sexual risk reduction intervention) with two assessment conditions (i.e., general health vs. sexual health survey). After completing their assigned baseline assessment, participants received the assigned intervention, and returned for follow-ups at 3, 6, 9, and 12 months. In this report, we summarize baseline data, which show high levels of sexual risk behavior; alcohol, marijuana, and tobacco use; and fast food consumption. Sexual risk behaviors and substance use were correlated. Participants reported high satisfaction with both interventions but ratings for the sexual risk reduction intervention were higher. Planned follow-up sessions, and subsequent analyses, will assess changes in health behaviors including sexual risk behaviors. This study design demonstrates one way to optimize the scientific yield of an RCT. PMID:23816489

Using Non-experimental Data to Estimate Treatment Effects

PubMed Central

Stuart, Elizabeth A.; Marcus, Sue M.; Horvitz-Lennon, Marcela V.; Gibbons, Robert D.; Normand, Sharon-Lise T.

2009-01-01

While much psychiatric research is based on randomized controlled trials (RCTs), where patients are randomly assigned to treatments, sometimes RCTs are not feasible. This paper describes propensity score approaches, which are increasingly used for estimating treatment effects in non-experimental settings. The primary goal of propensity score methods is to create sets of treated and comparison subjects who look as similar as possible, in essence replicating a randomized experiment, at least with respect to observed patient characteristics. A study to estimate the metabolic effects of antipsychotic medication in a sample of Florida Medicaid beneficiaries with schizophrenia illustrates methods. PMID:20563313

Summer School Effects in a Randomized Field Trial

ERIC Educational Resources Information Center

Zvoch, Keith; Stevens, Joseph J.

2013-01-01

This field-based randomized trial examined the effect of assignment to and participation in summer school for two moderately at-risk samples of struggling readers. Application of multiple regression models to difference scores capturing the change in summer reading fluency revealed that kindergarten students randomly assigned to summer school…

Being bad in a video game can make us more morally sensitive.

PubMed

Grizzard, Matthew; Tamborini, Ron; Lewis, Robert J; Wang, Lu; Prabhu, Sujay

2014-08-01

Several researchers have demonstrated that the virtual behaviors committed in a video game can elicit feelings of guilt. Researchers have proposed that such guilt could have prosocial consequences. However, this proposition has not been supported with empirical evidence. The current study examined this issue in a 2×2 (video game play vs. real world recollection×guilt vs. control) experiment. Participants were first randomly assigned to either play a video game or complete a memory recall task. Next, participants were randomly assigned to either a guilt-inducing condition (game play as a terrorist/recall of acts that induce guilt) or a control condition (game play as a UN soldier/recall of acts that do not induce guilt). Results of the study indicate several important findings. First, the current results replicate previous research indicating that immoral virtual behaviors are capable of eliciting guilt. Second, and more importantly, the guilt elicited by game play led to intuition-specific increases in the salience of violated moral foundations. These findings indicate that committing "immoral" virtual behaviors in a video game can lead to increased moral sensitivity of the player. The potential prosocial benefits of these findings are discussed.

Designing Studies That Would Address the Multilayered Nature of Health Care

PubMed Central

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

2010-01-01

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

The Effects of a Simulation Game on Learning of Geographic Information at the Fifth Grade Level. Final Report.

ERIC Educational Resources Information Center

Keach, Everett T., Jr.; Pierfy, David A.

The research in this report was conducted to assess the cognitive impact of a simulation game designed to teach selected geographic data about wind and ocean currents to fifth graders. A two-group, post-test research design was used. A random procedure was used to assign 185 students to two treatment groups. The sample was divided by sex, ranked…

Roads to Success: Estimated Impacts of an Education and Career Planning Program during Middle School. Final Report

ERIC Educational Resources Information Center

Chaplin, Duncan; Bleeker, Martha; Booker, Kevin

2010-01-01

Roads to Success (RTS) is a school and career planning program designed to be implemented for 45 minutes per week in grades 7 through 12. Researchers at Mathematica Policy Research used a random assignment design to estimate the impacts of receiving RTS in grades 7 and 8. More than half of the students in these schools were eligible for free or…

Using Bayesian Adaptive Trial Designs for Comparative Effectiveness Research: A Virtual Trial Execution.

PubMed

Luce, Bryan R; Connor, Jason T; Broglio, Kristine R; Mullins, C Daniel; Ishak, K Jack; Saunders, Elijah; Davis, Barry R

2016-09-20

Bayesian and adaptive clinical trial designs offer the potential for more efficient processes that result in lower sample sizes and shorter trial durations than traditional designs. To explore the use and potential benefits of Bayesian adaptive clinical trial designs in comparative effectiveness research. Virtual execution of ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) as if it had been done according to a Bayesian adaptive trial design. Comparative effectiveness trial of antihypertensive medications. Patient data sampled from the more than 42 000 patients enrolled in ALLHAT with publicly available data. Number of patients randomly assigned between groups, trial duration, observed numbers of events, and overall trial results and conclusions. The Bayesian adaptive approach and original design yielded similar overall trial conclusions. The Bayesian adaptive trial randomly assigned more patients to the better-performing group and would probably have ended slightly earlier. This virtual trial execution required limited resampling of ALLHAT patients for inclusion in RE-ADAPT (REsearch in ADAptive methods for Pragmatic Trials). Involvement of a data monitoring committee and other trial logistics were not considered. In a comparative effectiveness research trial, Bayesian adaptive trial designs are a feasible approach and potentially generate earlier results and allocate more patients to better-performing groups. National Heart, Lung, and Blood Institute.

The Role of Access to Head Start and Quality Ratings for Spanish-Speaking Dual Language Learners’ (DLLs) Participation in Early Childhood Education

PubMed Central

2014-01-01

Data from the Head Start Impact Study (N = 4,442) were used to test for differences between Spanish-speaking Dual Language Learners (DLLs) and monolingual English-speaking children in: (1) Head Start attendance rates when randomly assigned admission; and (2) quality ratings of other early childhood education (ECE) programs attended when not randomly assigned admission to Head Start. Logistic regressions showed that Spanish-speaking DLL children randomly assigned a spot in Head Start were more likely than monolingual-English learners to attend. Further, Spanish-speaking DLLs not randomly assigned a spot in Head Start were more likely to attend higher-quality ECE centers than non-DLL children. Policy implications are discussed, suggesting that, if given access, Spanish-speaking DLL families will take advantage of quality ECE programs. PMID:25018585

The safety of addition of nitrous oxide to general anaesthesia in at-risk patients having major non-cardiac surgery (ENIGMA-II): a randomised, single-blind trial.

PubMed

Myles, Paul S; Leslie, Kate; Chan, Matthew T V; Forbes, Andrew; Peyton, Philip J; Paech, Michael J; Beattie, W Scott; Sessler, Daniel I; Devereaux, P J; Silbert, Brendan; Schricker, Thomas; Wallace, Sophie

2014-10-18

Nitrous oxide is commonly used in general anaesthesia but concerns exist that it might increase perioperative cardiovascular risk. We aimed to gather evidence to establish whether nitrous oxide affects perioperative cardiovascular risk. We did an international, randomised, assessor-blinded trial in patients aged at least 45 years with known or suspected coronary artery disease having major non-cardiac surgery. Patients were randomly assigned via automated telephone service, stratified by site, to receive a general anaesthetic with or without nitrous oxide. Attending anaesthetists were aware of patients' group assignments, but patients and assessors were not. The primary outcome measure was a composite of death and cardiovascular complications (non-fatal myocardial infarction, stroke, pulmonary embolism, or cardiac arrest) within 30 days of surgery. Our modified intention-to-treat population included all patients randomly assigned to groups and undergoing induction of general anaesthesia for surgery. This trial is registered at ClinicalTrials.gov, number NCT00430989. Of 10,102 eligible patients, we enrolled 7112 patients between May 30, 2008, and Sept 28, 2013. 3543 were assigned to receive nitrous oxide and 3569 were assigned not to receive nitrous oxide. 3483 patients receiving nitrous oxide and 3509 not receiving nitrous oxide were assessed for the primary outcome. The primary outcome occurred in 283 (8%) patients receiving nitrous oxide and in 296 (8%) patients not receiving nitrous oxide (relative risk 0·96, 95% CI 0·83–1·12; p=0·64). Surgical site infection occurred in 321 (9%) patients assigned to nitrous oxide, and in 311 (9%) patients in the no-nitrous oxide group (p=0·61), and severe nausea and vomiting occurred in 506 patients (15%) assigned to nitrous oxide and 378 patients (11%) not assigned to nitrous oxide (p<0·0001). Our findings support the safety profile of nitrous oxide use in major non-cardiac surgery. Nitrous oxide did not increase the risk of death and cardiovascular complications or surgical-site infection, the emetogenic effect of nitrous oxide can be controlled with antiemetic prophylaxis, and a desired effect of reduced volatile agent use was shown. Australian National Health and Medical Research Council; Australian and New Zealand College of Anaesthetists; Heart and Stroke Foundation of Quebec, Heart and Stroke Foundation of Ontario, Canada; General Research Fund of the Research Grant Council, Hong Kong Special Administrative Region, China.

A Meta-Analysis of Massage Therapy Research

ERIC Educational Resources Information Center

Moyer, Christopher A.; Rounds, James; Hannum, James W.

2004-01-01

Massage therapy (MT) is an ancient form of treatment that is now gaining popularity as part of the complementary and alternative medical therapy movement. A meta-analysis was conducted of studies that used random assignment to test the effectiveness of MT. Mean effect sizes were calculated from 37 studies for 9 dependent variables. Single…

The Influence of Mathematics Vocabulary Instruction Embedded within Addition Tutoring for First-Grade Students with Mathematics Difficulty

ERIC Educational Resources Information Center

Powell, Sarah R.; Driver, Melissa K.

2015-01-01

Researchers and practitioners indicate students require explicit instruction on mathematics vocabulary terms, yet no study has examined the effects of an embedded vocabulary component within mathematics tutoring for early elementary students. First-grade students with mathematics difficulty (MD; n = 98) were randomly assigned to addition tutoring…

The Effects of Advance Organizers and Subtitles on EFL Learners' Listening Comprehension Skills

ERIC Educational Resources Information Center

Yang, Hui-Yu

2014-01-01

The present research reports the findings of three experiments which explore how subtitles and advance organizers affect EFL learners' listening comprehension of authentic videos. EFL learners are randomly assigned to one of two groups. The control group receives no treatment and the experimental group receives the experimental conditions of one…

The Roles of Explanation and Feedback in False Belief Understanding: A Microgenetic Analysis

ERIC Educational Resources Information Center

Guajardo, Nicole R.; Petersen, Rachel; Marshall, Timothy R.

2013-01-01

The authors examined effects of feedback and explanation on false belief performance. Thirty-three children (42-54 months; 15 girls, 18 boys) were randomly assigned to four treatment conditions: explanation, feedback, feedback researcher explains, and feedback child explains. Children completed false belief tasks during pretraining, 8 training…

Interactive Learning through Web-Mediated Peer Review of Student Science Reports

ERIC Educational Resources Information Center

Trautmann, Nancy M.

2009-01-01

Two studies analyzed impacts of writing and receiving web-mediated peer reviews on revision of research reports by undergraduate science students. After conducting toxicology experiments, 77 students posted draft reports and exchanged double-blind reviews. The first study randomly assigned students to four groups representing full, partial, or no…

Effective Secondary Science Programs: A Best-Evidence Synthesis

ERIC Educational Resources Information Center

Cheung, Alan; Slavin, Robert E.; Kim, Elizabeth; Lake, Cynthia

2015-01-01

This article reports a systematic review of research on science programs in grades 6-12. Twenty-one studies met inclusion criteria including use of randomized or matched assignment to conditions, measures that assess content emphasized equally in experimental and control groups, and a duration of at least 12 weeks. Programs fell into four…

Effective Secondary Science Programs: A Best-Evidence Synthesis

ERIC Educational Resources Information Center

Cheung, Alan; Slavin, Robert E.; Kim, Elizabeth; Lake, Cynthia

2017-01-01

This article reports a systematic review of research on science programs in grades 6-12. Twenty-one studies met inclusion criteria including use of randomized or quasi-experimental assignment to conditions, measures that assess content emphasized equally in experimental and control groups, and a duration of at least 12 weeks. Programs fell into…

Fostering Taiwanese Preschoolers' Understanding of the Addition-Subtraction Inverse Principle

ERIC Educational Resources Information Center

Lai, Meng-Lung; Baroody, Arthur J.; Johnson, Amanda R.

2008-01-01

The present research involved gauging preschoolers' learning potential for a key arithmetic concept, the addition-subtraction inverse principle (e.g., 2+1-1=2). Sixty 4- and 5-year-old Taiwanese children from two public preschools serving low- and middle-income families participated in the training experiment. Half were randomly assigned to an…

Effects of maternal nutrient restriction followed by realimentation during midgestation on uterine blood flow in beef cows

USDA-ARS?s Scientific Manuscript database

The objective was to examine the effect of maternal nutrient restriction followed by realimentation during mid-gestation on uterine blood flow (BF). On Day 30 of pregnancy, lactating, multiparous Simmental beef cows were assigned randomly to treatments: control (CON; 100% National Research Council; ...

Power Analysis for Cross Level Mediation in CRTs

ERIC Educational Resources Information Center

Kelcey, Ben

2014-01-01

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

Attributions of Responsibility for Obesity: Narrative Communication Reduces Reactive Counterarguing among Liberals

ERIC Educational Resources Information Center

Niederdeppe, Jeff; Shapiro, Michael A.; Porticella, Norman

2011-01-01

Informed by theory and research on attributions and narrative persuasion, we compared the effectiveness of narrative and nonnarrative messages in changing attributions of responsibility for causes and solutions related to obesity in the United States. We randomly assigned 500 adults to view one of three messages (narrative, evidence, and a hybrid…

Can Coloring Mandalas Reduce Anxiety? A Replication Study

ERIC Educational Resources Information Center

van der Vennet, Renee; Serice, Susan

2012-01-01

This experimental study replicated Curry and Kasser's (2005) research that tested whether coloring a mandala would reduce anxiety. After inducing an anxious mood via a writing activity, participants were randomly assigned to three groups that colored either on a mandala design, on a plaid design, or on a blank paper. Anxiety level was measured…

Processes and Outcomes of Joint Activity with E-Books for Promoting Kindergarteners' Emergent Literacy

ERIC Educational Resources Information Center

Shamir, Adina

2009-01-01

This research investigated the effects of an educational electronic book (e-book) on low socioeconomic status (SES) kindergarteners' emergent literacy while focusing on the relationship between process and outcomes during joint learning. The sample (96 kindergarteners, aged five to six) was randomly assigned to experimental (e-book activation) and…

Comparing Social Stories™ to Cool versus Not Cool

ERIC Educational Resources Information Center

Leaf, Justin B.; Mitchell, Erin; Townley-Cochran, Donna; McEachin, John; Taubman, Mitchell; Leaf, Ronald

2016-01-01

In this study we compared the cool versus not cool procedure to Social Stories™ for teaching various social behaviors to one individual diagnosed with autism spectrum disorder. The researchers randomly assigned three social skills to the cool versus not cool procedure and three social skills to the Social Stories™ procedure. Naturalistic probes…

Observing and Deterring Social Cheating on College Exams

ERIC Educational Resources Information Center

Fendler, Richard J.; Yates, Michael C.; Godbey, Johnathan M.

2018-01-01

This research introduces a unique multiple choice exam design to observe and measure the degree to which students copy answers from their peers. Using data collected from the exam, an empirical experiment is conducted to determine whether random seat assignment deters cheating relative to a control group of students allowed to choose their seats.…

Early Childhood Professional Development: Coaching and Coursework Effects on Indicators of Children's School Readiness

ERIC Educational Resources Information Center

Pianta, Robert; Hamre, Bridget; Downer, Jason; Burchinal, Margaret; Williford, Amanda; LoCasale-Crouch, Jennifer; Howes, Carollee; La Paro, Karen; Scott-Little, Catherine

2017-01-01

Research Findings: Effects on children's school readiness were evaluated for 2 interventions focused on improving teacher-student interactions (coursework, coaching) implemented sequentially across 2 years. Teachers from public prekindergarten programs in 10 locations were assigned randomly to treatment or control conditions in each year.…

Student Perceptions of the Classroom Environment: Actionable Feedback to Guide Core Instruction

ERIC Educational Resources Information Center

Nelson, Peter M.; Ysseldyke, James E.; Christ, Theodore J.

2015-01-01

The impact and feasibility of using student perceptions of the classroom teaching environment as an instructional feedback tool were explored. Thirty-one teachers serving 797 middle school students collected data twice across 3 weeks using the Responsive Environmental Assessment for Classroom Teaching (REACT). Researchers randomly assigned half of…

A randomized controlled design reveals barriers to citizenship for low-income immigrants.

PubMed

Hainmueller, Jens; Lawrence, Duncan; Gest, Justin; Hotard, Michael; Koslowski, Rey; Laitin, David D

2018-01-30

Citizenship endows legal protections and is associated with economic and social gains for immigrants and their communities. In the United States, however, naturalization rates are relatively low. Yet we lack reliable knowledge as to what constrains immigrants from applying. Drawing on data from a public/private naturalization program in New York, this research provides a randomized controlled study of policy interventions that address these constraints. The study tested two programmatic interventions among low-income immigrants who are eligible for citizenship. The first randomly assigned a voucher that covers the naturalization application fee among immigrants who otherwise would have to pay the full cost of the fee. The second randomly assigned a set of behavioral nudges, similar to outreach efforts used by service providers, among immigrants whose incomes were low enough to qualify them for a federal waiver that eliminates the application fee. Offering the fee voucher increased naturalization application rates by about 41%, suggesting that application fees act as a barrier for low-income immigrants who want to become US citizens. The nudges to encourage the very poor to apply had no discernible effect, indicating the presence of nonfinancial barriers to naturalization. Copyright © 2018 the Author(s). Published by PNAS.

A randomized controlled design reveals barriers to citizenship for low-income immigrants

PubMed Central

Hainmueller, Jens; Gest, Justin; Hotard, Michael; Koslowski, Rey; Laitin, David D.

2018-01-01

Citizenship endows legal protections and is associated with economic and social gains for immigrants and their communities. In the United States, however, naturalization rates are relatively low. Yet we lack reliable knowledge as to what constrains immigrants from applying. Drawing on data from a public/private naturalization program in New York, this research provides a randomized controlled study of policy interventions that address these constraints. The study tested two programmatic interventions among low-income immigrants who are eligible for citizenship. The first randomly assigned a voucher that covers the naturalization application fee among immigrants who otherwise would have to pay the full cost of the fee. The second randomly assigned a set of behavioral nudges, similar to outreach efforts used by service providers, among immigrants whose incomes were low enough to qualify them for a federal waiver that eliminates the application fee. Offering the fee voucher increased naturalization application rates by about 41%, suggesting that application fees act as a barrier for low-income immigrants who want to become US citizens. The nudges to encourage the very poor to apply had no discernible effect, indicating the presence of nonfinancial barriers to naturalization. PMID:29339470

Evaluating adolescent pregnancy programs: rethinking our priorities.

PubMed

Stahler, G J; DuCette, J P

1991-01-01

Noting that impact evaluations of adolescent pregnancy programs are characterized by poor quality, the authors recommend using a different standard in assessing the value of programs. While the number of adolescent pregnancy programs has multiplied during the last 3 decades, little is known about their impact in ameliorating the negative consequences of too-early childbearing. An ideal evaluation of these programs would randomly select and randomly assign subjects to experimental and control groups. But evaluations conducted by individual program generally face obstacles that limit the randomness of the study. most individual programs lack the financial resources and do not employ the full-time professional evaluators needed to carry out a valid evaluation. These factors result in too short an evaluation period, incomplete and inaccurate data, and lack of randomness in the assignment of control groups. To more accurately assess the impact of the programs, the authors recommend that individual programs focus on process evaluation and collection of complete and reliable data on their clients. From the onset, a program should have a clear description of its content, logic of intervention, and method of implementation. It should maintain thorough records on client characteristics, service utilization, and should conduct long-term follow-ups. For rigorous impact evaluations, programs should rely on 3rd party entities. These independent organizations -- universities or research institutes -- do not have a stake in the outcome of the evaluation, making the study all the more objective. Furthermore, they provide experienced researchers.

Long-term effect of resistant starch on cancer risk in carriers of hereditary colorectal cancer: an analysis from the CAPP2 randomised controlled trial.

PubMed

Mathers, John C; Movahedi, Mohammad; Macrae, Finlay; Mecklin, Jukka-Pekka; Moeslein, Gabriela; Olschwang, Sylviane; Eccles, Diana; Evans, Gareth; Maher, Eamonn R; Bertario, Lucio; Bisgaard, Marie-Luise; Dunlop, Malcolm; Ho, Judy W C; Hodgson, Shirley; Lindblom, Annika; Lubinski, Jan; Morrison, Patrick J; Murday, Victoria; Ramesar, Raj; Side, Lucy; Scott, Rodney J; Thomas, Huw J W; Vasen, Hans; Gerdes, Anne-Marie; Barker, Gail; Crawford, Gillian; Elliott, Faye; Pylvanainen, Kirsi; Wijnen, Juul; Fodde, Riccardo; Lynch, Henry; Bishop, D Timothy; Burn, John

2012-12-01

Observational studies report that higher intake of dietary fibre (a heterogeneous mix including non-starch polysaccharides and resistant starches) is associated with reduced risk of colorectal cancer, but no randomised trials with prevention of colorectal cancer as a primary endpoint have been done. We assessed the effect of resistant starch on the incidence of colorectal cancer. In the CAPP2 study, individuals with Lynch syndrome were randomly assigned in a two-by-two factorial design to receive 600 mg aspirin or aspirin placebo or 30 g resistant starch or starch placebo, for up to 4 years. Randomisation was done with a block size of 16. Post-intervention, patients entered into double-blind follow-up; participants and investigators were masked to treatment allocation. The primary endpoint for this analysis was development of colorectal cancer in participants randomly assigned to resistant starch or resistant-starch placebo with both intention-to-treat and per-protocol analyses. This study is registered, ISRCTN 59521990. 463 patients were randomly assigned to receive resistant starch and 455 to receive resistant-starch placebo. At a median follow-up 52·7 months (IQR 28·9-78·4), 53 participants developed 61 primary colorectal cancers (27 of 463 participants randomly assigned to resistant starch, 26 of 455 participants assigned to resistant-starch placebo). Intention-to-treat analysis of time to first colorectal cancer showed a hazard ratio (HR) of 1·40 (95% CI 0·78-2·56; p=0·26) and Poisson regression accounting for multiple primary events gave an incidence rate ratio (IRR) of 1·15 (95% CI 0·66-2·00; p=0·61). For those completing 2 years of intervention, per-protocol analysis yielded a HR of 1·09 (0·55-2·19, p=0·80) and an IRR of 0·98 (0·51-1·88, p=0·95). No information on adverse events was gathered during post-intervention follow-up. Resistant starch had no detectable effect on cancer development in carriers of hereditary colorectal cancer. Dietary supplementation with resistant starch does not emulate the apparently protective effect of diets rich in dietary fibre against colorectal cancer. European Union, Cancer Research UK, Bayer Corporation, National Starch and Chemical Co, UK Medical Research Council, Newcastle Hospitals Trustees, Cancer Council of Victoria Australia, THRIPP South Africa, The Finnish Cancer Foundation, SIAK Switzerland, and Bayer Pharma. Copyright © 2012 Elsevier Ltd. All rights reserved.

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

ERIC Educational Resources Information Center

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

2017-01-01

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

Random Assignment within Schools: Lessons Learned from the Teach for America Experiment

ERIC Educational Resources Information Center

Glazerman, Steven

2012-01-01

Randomized trials are a common way to provide rigorous evidence on the impacts of education programs. This article discusses the trade-offs associated with study designs that involve random assignment of students within schools and describes the experience from one such study of Teach for America (TFA). The TFA experiment faced challenges with…

Evaluating the Collaborative Strategic Reading Intervention: An Overview of Randomized Controlled Trial Options

ERIC Educational Resources Information Center

Hitchcock, John H.; Kurki, Anja; Wilkins, Chuck; Dimino, Joseph; Gersten, Russell

2009-01-01

When attempting to determine if an intervention has a causal impact, the "gold standard" of program evaluation is the randomized controlled trial (RCT). In education studies random assignment is rarely feasible at the student level, making RCTs harder to conduct. School-level assignment is more common but this often requires considerable resources…

Quantitative Skills, Critical Thinking, and Writing Mechanics in Blended versus Face-to-Face Versions of a Research Methods and Statistics Course

ERIC Educational Resources Information Center

Goode, Christopher T.; Lamoreaux, Marika; Atchison, Kristin J.; Jeffress, Elizabeth C.; Lynch, Heather L.; Sheehan, Elizabeth

2018-01-01

Hybrid or blended learning (BL) has been shown to be equivalent to or better than face-to-face (FTF) instruction in a broad variety of contexts. We randomly assigned students to either 50/50 BL or 100% FTF versions of a research methods and statistics in psychology course. Students who took the BL version of the course scored significantly lower…

Rehabilitation R and D Progress Reports, 1991

DTIC Science & Technology

1991-01-01

FES) is a challeng- work of our group , we are addressing the problem ing problem. A crucial difficulty is controlling the of designing a functional FES... control data. Background infor- research to design and evaluate interventions which mation will be obtained on the visual, sensory, help to reduce the...the senior was randomly Larger scale research is planned to investigate assigned to either a control or service group . the incidence of minor accidents

Are parent-reported outcomes for self-directed or telephone-assisted behavioral family intervention enhanced if parents are observed?

PubMed

Morawska, Alina; Sanders, Matthew R

2007-05-01

The study examined the effects of conducting observations as part of a broader assessment of families participating in behavior family intervention (BFI). It was designed to investigate whether the observations improve intervention outcomes. Families were randomly assigned to different levels of BFI or a waitlist control condition and subsequently randomly assigned to either observation or no-observation conditions. This study demonstrated significant intervention and observation effects. Mothers in more intensive BFI reported more improvement in their child's behavior and their own parenting. Observed mothers reported lower intensity of child behavior problems and more effective parenting styles. There was also a trend for less anger among mothers who were observed and evidence of an observation-intervention interaction for parental anger, with observed mothers in more intensive intervention reporting less anger compared to those not observed. Implications for clinical and research intervention contexts are discussed.

Threat and defense as goal regulation: from implicit goal conflict to anxious uncertainty, reactive approach motivation, and ideological extremism.

PubMed

Nash, Kyle; McGregor, Ian; Prentice, Mike

2011-12-01

Four studies investigated a goal regulation view of anxious uncertainty threat (Gray & McNaughton, 2000) and ideological defense. Participants (N = 444) were randomly assigned to have achievement or relationship goals implicitly primed. The implicit goal primes were followed by randomly assigned achievement or relationship threats that have reliably caused generalized, reactive approach motivation and ideological defense in past research. The threats caused anxious uncertainty (Study 1), reactive approach motivation (Studies 2 and 3), and reactive ideological conviction (Study 4) only when threat-relevant goals had first been primed, but not when threat-irrelevant goals had first been primed. Reactive ideological conviction (Study 4) was eliminated if participants were given an opportunity to attribute their anxiety to a mundane source. Results support a goal regulation view of anxious uncertainty, threat, and defense with potential for integrating theories of defensive compensation.

Family Caregiver Training Program (FCTP): A Randomized Controlled Trial.

PubMed

DiZazzo-Miller, Rosanne; Winston, Kristin; Winkler, Sandra L; Donovan, Mary L

The purpose of this study was to examine the effectiveness of the Family Caregiver Training Program (FCTP) for caregivers of people with dementia. A random assignment control group research design with a 3-mo follow-up was implemented. Thirty-six family caregivers of people with dementia demonstrated an increase in activity of daily living (ADL) knowledge (p < .001) and maintenance of that knowledge 3 mo posttest. Caregiver confidence, regardless of group assignment, improved; however, it was not maintained. Burden, depression, and occupational performance and satisfaction remained unchanged for the intervention group; however, physical health as it pertained to quality of life improved 3 mo posttest (p < .001). Findings demonstrate that the FCTP can effectively provide knowledge to family caregivers on how to assist people with dementia with ADLs. Even when standard care was provided, there was limited information on ADLs that family caregivers faced daily. Copyright © 2017 by the American Occupational Therapy Association, Inc.

Optimizing the scientific yield from a randomized controlled trial (RCT): evaluating two behavioral interventions and assessment reactivity with a single trial.

PubMed

Carey, Michael P; Senn, Theresa E; Coury-Doniger, Patricia; Urban, Marguerite A; Vanable, Peter A; Carey, Kate B

2013-09-01

Randomized controlled trials (RCTs) remain the gold standard for evaluating intervention efficacy but are often costly. To optimize their scientific yield, RCTs can be designed to investigate multiple research questions. This paper describes an RCT that used a modified Solomon four-group design to simultaneously evaluate two, theoretically-guided, health promotion interventions as well as assessment reactivity. Recruited participants (N = 1010; 56% male; 69% African American) were randomly assigned to one of four conditions formed by crossing two intervention conditions (i.e., general health promotion vs. sexual risk reduction intervention) with two assessment conditions (i.e., general health vs. sexual health survey). After completing their assigned baseline assessment, participants received the assigned intervention, and returned for follow-ups at 3, 6, 9, and 12 months. In this report, we summarize baseline data, which show high levels of sexual risk behavior; alcohol, marijuana, and tobacco use; and fast food consumption. Sexual risk behaviors and substance use were correlated. Participants reported high satisfaction with both interventions but ratings for the sexual risk reduction intervention were higher. Planned follow-up sessions, and subsequent analyses, will assess changes in health behaviors including sexual risk behaviors. This study design demonstrates one way to optimize the scientific yield of an RCT. © 2013 Elsevier Inc. All rights reserved.

77 FR 3284 - Comment Request for Information Collection for the H-1B Technical Skills Training (H-1B) and the...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-23

... participants at the time they are randomly assigned to a treatment or control group, ensure that random... assignment of participants into treatment and control groups. A Web- based PTS will execute the random... grantee sites and the services available to control group members. This qualitative information will...

Ecologically-Based Family Therapy Outcome with Substance Abusing Runaway Adolescents

PubMed Central

Slesnick, Natasha; Prestopnik, Jillian L.

2007-01-01

Runaway youth report a broader range and higher severity of substance-related, mental health and family problems relative to non-runaway youth. Most studies to date have collected self-report data on the family and social history; virtually no research has examined treatment effectiveness with this population. This study is a treatment development project in which 124 runaway youth were randomly assigned to 1) Ecologically-Based Family Therapy (EBFT) or 2) Service as Usual (SAU) through a shelter. Youth completed an intake, posttreatment, 6 and 12 month follow-up assessment. Youth assigned to EBFT reported greater reductions in overall substance abuse compared to youth assigned to SAU while other problem areas improved in both conditions. Findings suggest that EBFT is an efficacious intervention for this relatively severe population of youth. PMID:15878048

Effects of MyTeachingPartner-Math/Science on Teacher-Child Interactions in Prekindergarten Classrooms

ERIC Educational Resources Information Center

Whittaker, Jessica Vick; Kinzie, Mable B.; Williford, Amanda; DeCoster, Jamie

2016-01-01

Research Findings: This study examined the impact of MyTeachingPartner-Math/Science, a system of math and science curricula and professional development, on the quality of teachers' interactions with children in their classrooms. Schools were randomly assigned to 1 of 2 intervention conditions (Basic: curricula providing within-activity, embedded…

Effects of a Supplemental Intervention Focused in Equivalency Concepts for Students with Varying Abilities

ERIC Educational Resources Information Center

Hunt, Jessica H.

2014-01-01

The purpose of this study was to examine the effects of a Tier 2 supplemental intervention focused on rational number equivalency concepts and applications on the mathematics performance of third-grade students with and without mathematics difficulties. The researcher used a pretest-posttest control group design and random assignment of 19…

Teaching Efficacy in the Classroom: Skill Based Training for Teachers' Empowerment

ERIC Educational Resources Information Center

Karimzadeh, Mansoureh; Salehi, Hadi; Embi, Mohamed Amin; Nasiri, Mehdi; Shojaee, Mohammad

2014-01-01

This study aims to use an experimental research design to enhance teaching efficacy by social-emotional skills training in teachers. The statistical sample comprised of 68 elementary teachers (grades 4 and 5) with at least 10 years teaching experience and a bachelor's degree who were randomly assigned into control (18 female, 16 male) and…

The Effects of Alcohol on Intentions To Use Condoms.

ERIC Educational Resources Information Center

MacDonald, Tara K.; And Others

This study addressed the hypothesis that intentions to use condoms are affected by alcohol intoxication. Recruited for this research were 54 male students, who indicated on a pretest that they were sexually active, usually used condoms, and were social drinkers. Subjects were divided into groups of two or three and then randomly assigned to the…

The Counter-Normative Effects of Service-Learning: Fostering Attitudes toward Social Equality through Contact and Autonomy

ERIC Educational Resources Information Center

Brown, Margaret A.; Wymer, Jared D.; Cooper, Cierra S.

2016-01-01

Power dynamics are implicated in intergroup prosocial behavior (Nadler & Halabi, 2015). This research investigated two factors that influence the effect of intergroup prosocial behavior on views of social equality: amount of direct intergroup contact and type of helping. Students in a social psychology course (N = 93) were randomly assigned to…

Effect of a Specialized Classroom Counseling Intervention on Increasing Self-Efficacy among First-Grade Rural Students

ERIC Educational Resources Information Center

Bardhoshi, Gerta; Duncan, Kelly; Erford, Bradley T.

2018-01-01

This preliminary research examined the effectiveness of a classroom counseling intervention on student self-efficacy development. Five first-grade classrooms in a rural school with high rates of economic disparity were randomly assigned to either a set of 12 specialized lessons emphasizing self-efficacy or lessons from the existing core…

Peer Effects in Drug Use and Sex among College Students.

ERIC Educational Resources Information Center

Duncan, Greg J.; Boisjoly, Johanne; Kremer, Michael; Levy, Dan M.; Eccles, Jacque

2005-01-01

Past research suggests that congregating delinquent youth increases their likelihood of problem behavior. We test for analogous peer effects in the drug use and sexual behavior of male (n = 279) and female (n = 435) college students, using data on the characteristics of first-year roommates to whom they were randomly assigned. We find that males…

Tutor-Assisted Intensive Learning Strategies in Kindergarten: How Much Is Enough?

ERIC Educational Resources Information Center

Otaiba, Stephanie Al; Schatschneider, Christopher; Silverman, Eden

2005-01-01

The purpose of this research was to investigate the effectiveness of a tutoring intervention provided by community tutors to kindergarten students at risk for reading difficulties. The 73 students were randomly assigned to 1 of 3 conditions: (a) tutoring 4 days a week, (b) tutoring 2 days a week, or (c) a control condition that provided…

Training Early Childhood Educators to Promote Peer Interactions: Effects on Children's Aggressive and Prosocial Behaviors

ERIC Educational Resources Information Center

Girard, Lisa-Christine; Girolametto, Luigi; Weitzman, Elaine; Greenberg, Janice

2011-01-01

Research Findings: This study examined the effects of educators' participation in an in-service training program on the aggressive and prosocial behaviors of preschool-age children. Seventeen early childhood educators were randomly assigned to experimental and control groups. A total of 68 preschool children, 4 from each educator's classroom, also…

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

ERIC Educational Resources Information Center

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

2009-01-01

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

Early Numeracy Intervention Program for First-Grade Students with Mathematics Difficulties

ERIC Educational Resources Information Center

Bryant, Diane Pedrotty; Bryant, Brian R.; Roberts, Greg; Vaughn, Sharon; Pfannenstiel, Kathleen Hughes; Porterfield, Jennifer; Gersten, Russell

2011-01-01

The purpose of this study was to determine the effects of an early numeracy preventative Tier 2 intervention on the mathematics performance of first-grade students with mathematics difficulties. Researchers used a pretest-posttest control group design with randomized assignment of 139 students to the Tier 2 treatment condition and 65 students to…

Affective Learning Outcomes in Workplace Training: A Test of Synchronous vs. Asynchronous Online Learning Environments

ERIC Educational Resources Information Center

Cleveland-Innes, Martha; Ally, Mohamed

2004-01-01

Research employing an experimental design pilot-tested two delivery platforms, WebCT™ and vClass™, for the generation of affective learning outcomes in the workplace. Using a sample of volunteer participants in the help-desk industry, participants were randomly assigned to one of the two types of delivery software. Thirty-eight subjects…

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

ERIC Educational Resources Information Center

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

2011-01-01

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

Media Literacy Interventions: What Makes Them Boom or Boomerang?

ERIC Educational Resources Information Center

Byrne, Sahara

2009-01-01

This study advances research on media literacy by comparing the effectiveness of two versions of a media literacy intervention over time. Participants (156 children in 4th or 5th grade) were randomly assigned to one of two treatment groups or a control group. Both treatment groups were exposed to an instructional intervention designed to reduce…

A Kindergarten Number-Sense Intervention with Contrasting Practice Conditions for Low-Achieving Children

ERIC Educational Resources Information Center

Dyson, Nancy; Jordan, Nancy C.; Beliakoff, Amber; Hassinger-Das, Brenna

2015-01-01

The efficacy of a research-based number-sense intervention for low-achieving kindergartners was examined. Children (N = 126) were randomly assigned to 1 of 3 conditions: a number-sense intervention followed by a number-fact practice session, an identical number-sense intervention followed by a number-list practice session, or a business-as-usual…

Classroom Management Intervention: The Effects of Training and Mentoring on the Inductee Teacher's Behavior.

ERIC Educational Resources Information Center

Stallion, Brenda K.

The purpose of this study was to assess the effects of a program for training teachers in classroom management that was embedded in a mentor and beginning teacher induction program. Both mentor teachers and beginning teachers were randomly assigned to treatment conditions. The research sought to determine the effects of the classroom management…

The Use of Choice-Based Distraction to Decrease the Distress of Children at the Dentist

ERIC Educational Resources Information Center

Filcheck, Holly A.; Allen, Keith D.; Ogren, Hilary; Darby, James Brandt; Holstein, Brian; Hupp, Steve

2005-01-01

This research was conducted to examine whether choice-based distraction provides an effective means of reducing the distress of children undergoing routine dental treatment. Sixty children between the ages of 5-12 who required restorative dental treatment were assigned randomly to either a Control group or a Distraction group in which the…

The Effects of Swim Training on Respiratory Aspects of Speech Production in Adolescents with Down Syndrome

ERIC Educational Resources Information Center

Casey, Amanda Faith; Emes, Claudia

2011-01-01

Reduced respiratory muscle strength in individuals with Down syndrome (DS) may affect speech respiratory variables such as maximum phonation duration (MPD), initiation volume, and expired mean airflow. Researchers randomly assigned adolescents with DS (N = 28) to either 12 weeks of swim training (DS-ST) or a control group (DS-NT). Repeated…

Sericea lespdeza as an aid in the control of Emeria spp. in lambs

USDA-ARS?s Scientific Manuscript database

The objective of this research was to examine the effects of feeding sericea lespedeza leaf meal [SL, Lespedeza cuneata (Dum.-Cours. G. Don)] on control of coccidiosis in lambs. In Exp. 1, naturally infected lambs (n = 76) were weaned (102.7 ± 1.4 d of age) in May (spring) and randomly assigned to ...

Feedback Both Helps and Hinders Learning: The Causal Role of Prior Knowledge

ERIC Educational Resources Information Center

Fyfe, Emily R.; Rittle-Johnson, Bethany

2016-01-01

Feedback can be a powerful learning tool, but its effects vary widely. Research has suggested that learners' prior knowledge may moderate the effects of feedback; however, no causal link has been established. In Experiment 1, we randomly assigned elementary school children (N = 108) to a condition based on a crossing of 2 factors: induced strategy…

Methodological Considerations in Evaluating School-Based Programs to Promote Social Competence and Reduce Problem Behavior

ERIC Educational Resources Information Center

Massetti, Greta M.; Crean, Hugh; Johnson, Deborah; DuBois, David; Ji, Peter

2009-01-01

Interventions that aim to promote social competence, reduce problem behavior, and improve school climate are common at all levels of schooling. This whole-school focus, coupled with researchers' concerns about contamination or spillover effects in evaluations that randomly assign classrooms or students to conditions, as well as advances in…

The Effect of Brief Functional Relaxation on College Students' Needle Anxiety during Injected Vaccinations

ERIC Educational Resources Information Center

McWhorter, Linda G.; Gil-Rivas, Virginia

2014-01-01

Objective: This study examined the effect of brief functional relaxation (FR) training on needle anxiety (NA) during vaccinations. Participants: From October 2010 through May 2012, 48 undergraduates were recruited through the psychology research participant pool. Methods: Students (N = 48) were randomly assigned to a 15-minute brief FR session…

The Promise of Multimedia Stories for Kindergarten Children at Risk

ERIC Educational Resources Information Center

Verhallen, Maria J. A. J.; Bus, Adriana G.; de Jong, Maria T.

2006-01-01

This research focuses on the ability of book-based animated stories, when well designed and produced, to have positive effects on young viewers' narrative comprehension and language skills. Sixty 5-year-olds, learning Dutch as a 2nd language, were randomly assigned to 4 experimental and 2 control conditions. The children profited to some extent…

Mood Effects of Alcohol and Expectancies during the Menstrual Cycle.

ERIC Educational Resources Information Center

Adesso, Vincent J.; Freitag, Wendy J.

This research attempted to develop a profile of women's moods across the menstrual cycle and to determine alcohol's effects upon those moods. The Profile of Mood States was used to measure mood in 96 female college students who were heavy drinkers. Subjects were randomly assigned to the cells of the balanced placebo design with equal numbers in…

Single-Case Experimental Designs in Educational Research: A Methodology for Causal Analyses in Teaching and Learning

ERIC Educational Resources Information Center

Plavnick, Joshua B.; Ferreri, Summer J.

2013-01-01

Current legislation requires educational practices be informed by science. The effort to establish educational practices supported by science has, to date, emphasized experiments with large numbers of participants who are randomly assigned to an intervention or control condition. A potential limitation of such an emphasis at the expense of other…

Interesting Practitioners in Training in Empirically Supported Treatments: Research Reviews versus Case Studies

PubMed Central

Stewart, Rebecca E.; Chambless, Dianne L.

2010-01-01

It has been repeatedly demonstrated that clinicians rely more on clinical judgment than on research findings. We hypothesized that psychologists in practice might be more open to adopting empirically supported treatments (ESTs) if outcome results were presented with a case study. Psychologists in private practice (N = 742) were randomly assigned to receive a research review of data from randomized controlled trials of cognitive-behavioral treatment (CBT) and medication for bulimia, a case study of CBT for a fictional patient with bulimia, or both. Results indicated that the inclusion of case examples renders ESTs more compelling and interests clinicians in gaining training. Despite these participants’ training in statistics, the inclusion of the statistical information had no influence on attitudes or training willingness beyond that of the anecdotal case information. PMID:19899142

Randomized trial of the effect of drug presentation on asthma outcomes: the American Lung Association Asthma Clinical Research Centers.

PubMed

Wise, Robert A; Bartlett, Susan J; Brown, Ellen D; Castro, Mario; Cohen, Rubin; Holbrook, Janet T; Irvin, Charles G; Rand, Cynthia S; Sockrider, Marianna M; Sugar, Elizabeth A

2009-09-01

Information that enhances expectations about drug effectiveness improves the response to placebos for pain. Although asthma symptoms often improve with placebo, it is not known whether the response to placebo or active treatment can be augmented by increasing expectation of benefit. The study objective was to determine whether response to placebo or a leukotriene antagonist (montelukast) can be augmented by messages that increase expectation of benefit. A randomized 20-center controlled trial enrolled 601 asthmatic patients with poor symptom control who were assigned to one of 5 study groups. Participants were randomly assigned to one of 4 treatment groups in a factorial design (ie, placebo with enhanced messages, placebo with neutral messages, montelukast with enhanced messages, or montelukast with neutral messages) or to usual care. Assignment to study drug was double masked, assignment to message content was single masked, and usual care was not masked. The enhanced message aimed to increase expectation of benefit from the drug. The primary outcome was mean change in daily peak flow over 4 weeks. Secondary outcomes included lung function and asthma symptom control. Peak flow and other lung function measures were not improved in participants assigned to the enhanced message groups versus the neutral messages groups for either montelukast or placebo; no differences were noted between the neutral placebo and usual care groups. Placebo-treated participants had improved asthma control with the enhanced message but not montelukast-treated participants; the neutral placebo group did have improved asthma control compared with the usual care group after adjusting for baseline difference. Headaches were more common in participants provided messages that mentioned headache as a montelukast side effect. Optimistic drug presentation augments the placebo effect for patient-reported outcomes (asthma control) but not lung function. However, the effect of montelukast was not enhanced by optimistic messages regarding treatment effectiveness.

The Effect of Oral Midazolam and Chloral Hydrate Before Echocardiography in Pediatric Patients: A Randomized Double-Blind Clinical Trial.

PubMed

Salehi, Forod; Riasi, Hamid Reza; Ebrahimzadeh, Ali; Askari Janatabadi, Sima

2017-01-01

This study aimed to compare the effects of oral midazolam and chloral hydrate in pre-echocardiography sedation of children. In this double-blind clinical trial, 68 children were randomly assigned to midazolam (0.2 mg/kg) or chloral hydrate (50 mg/kg). The intensity, duration, and onset of the drugs' effects were assessed. Data were analyzed using the χ 2 and Mann-Whitney tests ( P ≤ .05). The average onset and duration of sedation in the children assigned to midazolam was shorter than in those assigned chloral hydrate (6.35 ± 3.65 and 19.14 ± 5.86 minutes, P = .0001, and 27.64 ± 8.34 and 48.97 ± 14.81 minutes, P = .0001). Gastrointestinal side effects were more frequent in the chloral hydrate group (23.5% against 0%, P = .003). According to the results of the present study, chloral hydrate and midazolam can be appropriate choices for pre-echocardiography sedation of patients without cardiovascular risk factors. Considering the similar effectiveness, more rapid onset, and shorter duration of sedation, besides less side effects in the midazolam group, researchers recommend the routine use of this drug.

The Effectiveness of the Within Our Reach Relationship Education Program for Couples: Findings from a Federal Randomized Trial.

PubMed

Rhoades, Galena K

2015-12-01

This study examined the effectiveness of a couple-based relationship education program, Within Our Reach. Secondary data (n = 3,609) were analyzed from the federal Supporting Healthy Marriage project. Couples were randomly assigned to receive Within Our Reach and associated services or to a no-treatment (treatment-as-usual) control group. Those assigned to Within Our Reach reported better couple and individual outcomes on 8 of 12 outcomes measured (M ES = .15) at the 12-month follow-up and 6 of 10 outcomes measured at the 30-month follow-up (M ES = .14), including higher relationship happiness, more warmth and support, more positive communication, less negative behavior and emotion, less psychological abuse, less physical assault (for men), lower psychological distress (for women), and less infidelity. They were also less likely to report that their marriage was in trouble. These effects were generally small in size and many were replicated across the two follow-ups. There were no significant differences between those assigned to Within Our Reach versus control on cooperative parenting, severe psychological assault, or percent married. Implications for future research, programming, and policy are discussed. © 2015 Family Process Institute.

Exercise training for depressed older adults with Alzheimer's disease.

PubMed

Williams, C L; Tappen, R M

2008-01-01

The purpose of this study was to compare the effects of 16 weeks of a comprehensive exercise routine to supervised walking and social conversation on depression in nursing home residents with Alzheimer's disease (AD). This study was a three-group, repeated-measures design with random assignment to treatment group. Forty-five nursing home residents with moderate to severe AD were randomly assigned to a 16-week programme of comprehensive exercise, supervised walking or social conversation. Raters were blinded to treatment group assignment. Major outcome variables were depression measured by the Cornell Scale for Depression in Dementia, mood measured by the Dementia Mood Assessment Scale and the Alzheimer's Mood Scale, and affect measured by the Observed Affect Scale. Depression was reduced in all three groups with some evidence of superior benefit from exercise. Depression is a common problem with serious and costly consequences for nursing home residents with AD. Exercise as a behavioural approach to treatment of depression in nursing home residents with severe AD evidenced a clear benefit to participants in this study. More research is needed to clarify the relative benefits of different types of exercise in conjunction with or without pharmacological intervention.

Reference Values of Within-District Intraclass Correlations of Academic Achievement by District Characteristics: Results from a Meta-Analysis of District-Specific Values

ERIC Educational Resources Information Center

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

2014-01-01

Randomized experiments are often considered the strongest designs to study the impact of educational interventions. Perhaps the most prevalent class of designs used in large scale education experiments is the cluster randomized design in which entire schools are assigned to treatments. In cluster randomized trials (CRTs) that assign schools to…

Stability of parental understanding of random assignment in childhood leukemia trials: an empirical examination of informed consent.

PubMed

Greenley, Rachel Neff; Drotar, Dennis; Zyzanski, Stephen J; Kodish, Eric

2006-02-20

To examine stability versus change in parental understanding of random assignment in randomized clinical trials (RCTs) for pediatric leukemia and to identify factors associated with changes in understanding. Eighty-four parents of children diagnosed with acute lymphoblastic leukemia or acute myeloid leukemia who were enrolled onto a pediatric leukemia RCT at one of six US children's hospitals participated. Parents were interviewed twice, once within 48 hours after the Informed Consent Conference (ICC; time 1 [T1]) and again 6 months later (time 2 [T2]). Interviews focused on parental understanding of key components of the RCT, including random assignment. Interviews were audiotaped, transcribed, and later analyzed. Changes in understanding of random assignment occurred in 19% of parents, with 17% of parents deteriorating in understanding from T1 to T2. Forty-nine percent of parents failed to understand random assignment at both times. Factors associated with understanding at both times included majority ethnicity, high socioeconomic status, parental reading of consent document, and presence of a nurse during the ICC. Physician discussion of specific components of the RCT was also associated with understanding at both times. Female caregivers and parents of low socioeconomic status were overrepresented among those who showed decay in understanding from T1 to T2. Parents showed little gain in understanding over time. Factors that predicted understanding at diagnosis as well as sustained understanding over time may be important intervention targets. Attention to both modifiable and nonmodifiable barriers is important for clinical practice.

High capacity low delay packet broadcasting multiaccess schemes for satellite repeater systems

NASA Astrophysics Data System (ADS)

Bose, S. K.

1980-12-01

Demand assigned packet radio schemes using satellite repeaters can achieve high capacities but often exhibit relatively large delays under low traffic conditions when compared to random access. Several schemes which improve delay performance at low traffic but which have high capacity are presented and analyzed. These schemes allow random acess attempts by users, who are waiting for channel assignments. The performance of these are considered in the context of a multiple point communication system carrying fixed length messages between geographically distributed (ground) user terminals which are linked via a satellite repeater. Channel assignments are done following a BCC queueing discipline by a (ground) central controller on the basis of requests correctly received over a collision type access channel. In TBACR Scheme A, some of the forward message channels are set aside for random access transmissions; the rest are used in a demand assigned mode. Schemes B and C operate all their forward message channels in a demand assignment mode but, by means of appropriate algorithms for trailer channel selection, allow random access attempts on unassigned channels. The latter scheme also introduces framing and slotting of the time axis to implement a more efficient algorithm for trailer channel selection than the former.

Effect of a cash transfer programme for schooling on prevalence of HIV and herpes simplex type 2 in Malawi: a cluster randomised trial.

PubMed

Baird, Sarah J; Garfein, Richard S; McIntosh, Craig T; Ozler, Berk

2012-04-07

Lack of education and an economic dependence on men are often suggested as important risk factors for HIV infection in women. We assessed the efficacy of a cash transfer programme to reduce the risk of sexually transmitted infections in young women. In this cluster randomised trial, never-married women aged 13-22 years were recruited from 176 enumeration areas in the Zomba district of Malawi and randomly assigned with computer-generated random numbers by enumeration area (1:1) to receive cash payments (intervention group) or nothing (control group). Intervention enumeration areas were further randomly assigned with computer-generated random numbers to conditional (school attendance required to receive payment) and unconditional (no requirements to receive payment) groups. Participants in both intervention groups were randomly assigned by a lottery to receive monthly payments ranging from US$1 to $5, while their parents were independently assigned with computer-generated random numbers to receive $4-10. Behavioural risk assessments were done at baseline and 12 months; serology was tested at 18 months. Participants were not masked to treatment status but counsellors doing the serologic testing were. The primary outcomes were prevalence of HIV and herpes simplex virus 2 (HSV-2) at 18 months and were assessed by intention-to-treat analyses. The trial is registered, number NCT01333826. 88 enumeration areas were assigned to receive the intervention and 88 as controls. For the 1289 individuals enrolled in school at baseline with complete interview and biomarker data, weighted HIV prevalence at 18 month follow-up was 1·2% (seven of 490 participants) in the combined intervention group versus 3·0% (17 of 799 participants) in the control group (adjusted odds ratio [OR] 0·36, 95% CI 0·14-0·91); weighted HSV-2 prevalence was 0·7% (five of 488 participants) versus 3·0% (27 of 796 participants; adjusted OR 0·24, 0·09-0·65). In the intervention group, we noted no difference between conditional versus unconditional intervention groups for weighted HIV prevalence (3/235 [1%] vs 4/255 [2%]) or weighted HSV-2 prevalence (4/233 [1%] vs 1/255 [<1%]). For individuals who had already dropped out of school at baseline, we detected no significant difference between intervention and control groups for weighted HIV prevalence (23/210 [10%] vs 17/207 [8%]) or weighted HSV-2 prevalence (17/211 [8%] vs 17/208 [8%]). Cash transfer programmes can reduce HIV and HSV-2 infections in adolescent schoolgirls in low-income settings. Structural interventions that do not directly target sexual behaviour change can be important components of HIV prevention strategies. Global Development Network, Bill & Melinda Gates Foundation, National Bureau of Economic Research Africa Project, World Bank's Research Support Budget, and several World Bank trust funds (Gender Action Plan, Knowledge for Change Program, and Spanish Impact Evaluation fund). Copyright © 2012 Elsevier Ltd. All rights reserved.

True and Quasi-Experimental Designs. ERIC/AE Digest.

ERIC Educational Resources Information Center

Gribbons, Barry; Herman, Joan

Among the different types of experimental design are two general categories: true experimental designs and quasi- experimental designs. True experimental designs include more than one purposively created group, common measured outcomes, and random assignment. Quasi-experimental designs are commonly used when random assignment is not practical or…

40 CFR 799.9120 - TSCA acute dermal toxicity.

Code of Federal Regulations, 2011 CFR

2011-07-01

... identification number. A system to randomly assign animals to test groups and control groups is required. (E... source of test animals. (2) Method of randomization in assigning animals to test and control groups. (3... CONTROL ACT (CONTINUED) IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE TESTING REQUIREMENTS...

40 CFR 799.9120 - TSCA acute dermal toxicity.

Code of Federal Regulations, 2010 CFR

2010-07-01

... identification number. A system to randomly assign animals to test groups and control groups is required. (E... source of test animals. (2) Method of randomization in assigning animals to test and control groups. (3... CONTROL ACT (CONTINUED) IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE TESTING REQUIREMENTS...

40 CFR 799.9110 - TSCA acute oral toxicity.

Code of Federal Regulations, 2011 CFR

2011-07-01

... number. A system to assign animals to test groups and control groups randomly is required. (E) Housing... randomization in assigning animals to test and control groups. (3) Rationale for selection of species, if other... CONTROL ACT (CONTINUED) IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE TESTING REQUIREMENTS...

40 CFR 799.9110 - TSCA acute oral toxicity.

Code of Federal Regulations, 2013 CFR

2013-07-01

... number. A system to assign animals to test groups and control groups randomly is required. (E) Housing... randomization in assigning animals to test and control groups. (3) Rationale for selection of species, if other... CONTROL ACT (CONTINUED) IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE TESTING REQUIREMENTS...

40 CFR 799.9120 - TSCA acute dermal toxicity.

Code of Federal Regulations, 2012 CFR

2012-07-01

... identification number. A system to randomly assign animals to test groups and control groups is required. (E... source of test animals. (2) Method of randomization in assigning animals to test and control groups. (3... CONTROL ACT (CONTINUED) IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE TESTING REQUIREMENTS...

40 CFR 799.9110 - TSCA acute oral toxicity.

Code of Federal Regulations, 2010 CFR

2010-07-01

... number. A system to assign animals to test groups and control groups randomly is required. (E) Housing... randomization in assigning animals to test and control groups. (3) Rationale for selection of species, if other... CONTROL ACT (CONTINUED) IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE TESTING REQUIREMENTS...

40 CFR 799.9110 - TSCA acute oral toxicity.

Code of Federal Regulations, 2014 CFR

2014-07-01

... number. A system to assign animals to test groups and control groups randomly is required. (E) Housing... randomization in assigning animals to test and control groups. (3) Rationale for selection of species, if other... CONTROL ACT (CONTINUED) IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE TESTING REQUIREMENTS...

40 CFR 799.9120 - TSCA acute dermal toxicity.

Code of Federal Regulations, 2014 CFR

2014-07-01

... identification number. A system to randomly assign animals to test groups and control groups is required. (E... source of test animals. (2) Method of randomization in assigning animals to test and control groups. (3... CONTROL ACT (CONTINUED) IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE TESTING REQUIREMENTS...

40 CFR 799.9110 - TSCA acute oral toxicity.

Code of Federal Regulations, 2012 CFR

2012-07-01

... number. A system to assign animals to test groups and control groups randomly is required. (E) Housing... randomization in assigning animals to test and control groups. (3) Rationale for selection of species, if other... CONTROL ACT (CONTINUED) IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE TESTING REQUIREMENTS...

40 CFR 799.9120 - TSCA acute dermal toxicity.

Code of Federal Regulations, 2013 CFR

2013-07-01

... identification number. A system to randomly assign animals to test groups and control groups is required. (E... source of test animals. (2) Method of randomization in assigning animals to test and control groups. (3... CONTROL ACT (CONTINUED) IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE TESTING REQUIREMENTS...

Effects of Music Instruction with Bamboo Xylophone Accompaniment on Singing Achievement among Second-Grade Children

ERIC Educational Resources Information Center

Simeon, Jinky Jane C.; Ku, Agnes Chun Moi

2015-01-01

The aim of this research is to determine the effect of music instruction with bamboo xylophone as harmonic accompaniment on the singing achievement of second-grade children. Eighty children (N = 80) from four randomly selected classes in two different public schools in the city of Kota Kinabalu participated in this study and they were assigned to…

What Would Batman Do? Self-Distancing Improves Executive Function in Young Children

ERIC Educational Resources Information Center

White, Rachel E.; Carlson, Stephanie M.

2016-01-01

This experimental research assessed the influence of graded levels of self-distancing--psychological distancing from one's egocentric perspective--on executive function (EF) in young children. Three- (n = 48) and 5-year-old (n = 48) children were randomly assigned to one of four manipulations of distance from the self (from proximal to distal:…

Investigating the Washback Effects of Task-Based Instruction on the Iranian EFL Learners' Vocabulary Learning

ERIC Educational Resources Information Center

Hamzeh, Alireza

2016-01-01

The current research was an attempt to explore the washback impact of task-based instruction (TBI) on EFL Iranian learners' vocabulary development. To this end, conducting an Oxford Placement Test (OPT), 30 out of 72 EFL Iranian learners studying in an English language institute, were randomly selected. Then, they were assigned to experimental (N…

Effects of a Rubric-Driven Assessment on Teacher Performance with Regard to Behavioral Management Skills

ERIC Educational Resources Information Center

Simmons, Kevin R.

2010-01-01

The purpose of this researcher was to evaluate the efficacy of an in-service training program in the use of a rubric-driven assessment system for classroom behavior management. Thirty randomly assigned teachers received in-service training and 30 teachers served as a control group. The use of a rubric-driven assessment provided both teachers and…

Effectiveness of a Test-Taking Strategy on Achievement in Essay Tests for Students with Learning Disabilities

ERIC Educational Resources Information Center

Therrien, William J.; Hughes, Charles; Kapelski, Cory; Mokhtari, Kouider

2009-01-01

Research was conducted to ascertain if an essay-writing strategy was effective at improving the achievement on essay tests for 7th- and 8th-grade students with reading and writing disabilities. Students were assigned via a stratified random sample to treatment or control group. Student scores were also compared to students without learning…

The Effects of Content-Enriched Shared Book Reading versus Vocabulary-Only Discussions on the Vocabulary Outcomes of Preschool Dual Language Learners

ERIC Educational Resources Information Center

Pollard-Durodola, Sharolyn D.; Gonzalez, Jorge E.; Saenz, Laura; Resendez, Nora; Kwok, Oiman; Zhu, Leina; Davis, Heather

2018-01-01

Research Findings: This study compared the effects of content-based shared book-reading instruction versus an explicit vocabulary-only condition on the vocabulary development of preschool dual language learners (DLLs). Using shared book reading as the mode of instruction, we randomly assigned 48 bilingual preschool teachers and 281…

Prediction of Genetic Values for Feed Intake from Individual Body Weight Gain and Total Feed Intake of the Pen

USDA-ARS?s Scientific Manuscript database

Records of individual feed intake (FI) and gain (G) were obtained from the Germ Plasm Evaluation (GPE) program at US Meat Animal Research Center (USMARC). Animals were randomly assigned to pens. Only pens with 6 to 9 steers were used for this study (Data Set 1,289 steers). Variance components and g...

Humor, Self-Attitude, Emotions, and Cognitions in Group Art Therapy with War Veterans

ERIC Educational Resources Information Center

Kopytin, Alexander; Lebedev, Alexey

2013-01-01

This article presents findings from a study of the therapeutic effects of group art therapy in a psychotherapy unit of a Russian hospital for war veterans. The researchers randomly assigned 112 veterans being treated for stress-related disorders to an experimental group (art therapy) and a control group. The emphasis was on the use of humor in the…

WWC Quick Review of the Article "Promoting Academic and Social-Emotional School Readiness: The Head Start REDI Program"

ERIC Educational Resources Information Center

What Works Clearinghouse, 2009

2009-01-01

This study examined whether the Head Start Research-based Developmentally Informed (REDI) program is more effective than the standard Head Start program at improving the language, emergent literacy, and social-emotional skills of preschoolers. Head Start centers in three Pennsylvania counties were randomly assigned either to use the REDI program…

Research and Teaching: Exploring the Use of an Online Quiz Game to Provide Formative Feedback in a Large-Enrollment, Introductory Biochemistry Course

ERIC Educational Resources Information Center

Milner, Rachel; Parrish, Jonathan; Wright, Adrienne; Gnarpe, Judy; Keenan, Louanne

2015-01-01

In a large-enrollment, introductory biochemistry course for nonmajors, the authors provide students with formative feedback through practice questions in PDF format. Recently, they investigated possible benefits of providing the practice questions via an online game (Brainspan). Participants were randomly assigned to either the online game group…

Comparison of Two Different Techniques of Cooperative Learning Approach: Undergraduates' Conceptual Understanding in the Context of Hormone Biochemistry

ERIC Educational Resources Information Center

Mutlu, Ayfer

2018-01-01

The purpose of the research was to compare the effects of two different techniques of the cooperative learning approach, namely Team-Game Tournament and Jigsaw, on undergraduates' conceptual understanding in a Hormone Biochemistry course. Undergraduates were randomly assigned to Group 1 (N = 23) and Group 2 (N = 29). Instructions were accomplished…

Assessing the Effectiveness of a 3-D Instructional Game on Improving Mathematics Achievement and Motivation of Middle School Students

ERIC Educational Resources Information Center

Bai, Haiyan; Pan, Wei; Hirumi, Astusi; Kebritchi, Mansureh

2012-01-01

This research study assessed the effectiveness of a three-dimensional mathematics game, DimensionM, through a pretest-posttest control group quasi-experimental design. Participants consisted of 437 eighth graders. The classrooms were randomly assigned either to the treatment group that utilized DimensionM as a supplement to regular classroom…

Predictors of Substance Use and Family Therapy Outcome among Physically and Sexually Abused Runaway Adolescents

ERIC Educational Resources Information Center

Slesnick, Natasha; Bartle-Haring, Suzanne; Gangamma, Rashmi

2006-01-01

There is a dearth of research that examines the impact of family systems therapy on problems among sexually and/or physically abused youth. Given this void, differential outcome and predictors of substance use change were evaluated for abused, as compared with nonabused, runaway adolescents who were randomly assigned to family therapy or treatment…

The Universality of Self-Generated Verbal Mediators as a Means of Enhancing Memory Processes. Research Report No. 58.

ERIC Educational Resources Information Center

Buium, Nissan; Turnure, James E.

In a replication of a similar study with American children, 56 normal native Israeli children (5-years-old) were studied to determine the universality of self-generated verbal mediators as a means of enhancing memory processes. Eight Ss, randomly selected, were assigned in each of the following conditions: labeling, sentence generation, listening…

Controlling for Response Order Effects in Ranking Items Using Latent Choice Factor Modeling

ERIC Educational Resources Information Center

Vriens, Ingrid; Moors, Guy; Gelissen, John; Vermunt, Jeroen K.

2017-01-01

Measuring values in sociological research sometimes involves the use of ranking data. A disadvantage of a ranking assignment is that the order in which the items are presented might influence the choice preferences of respondents regardless of the content being measured. The standard procedure to rule out such effects is to randomize the order of…

Does Causal Action Facilitate Causal Perception in Infants Younger than 6 Months of Age?

ERIC Educational Resources Information Center

Rakison, David H.; Krogh, Lauren

2012-01-01

Previous research has established that infants are unable to perceive causality until 6 1/4 months of age. The current experiments examined whether infants' ability to engage in causal action could facilitate causal perception prior to this age. In Experiment 1, 4 1/2-month-olds were randomly assigned to engage in causal action experience via…

Sexual Arousal and Self-Control: Results from a Preliminary Experimental Test of the Stability of Self-Control

ERIC Educational Resources Information Center

Bouffard, Jeffrey; Kunzi, Tasha

2012-01-01

A central proposition of Gottfredson and Hirschi's (1990) General Theory of Crime is the relative stability of low self-control, however research on "self-control strength" suggests that it may vary across contexts. The current study examines these differing conceptions by randomly assigning participants to one of two sexual arousal conditions or…

Effect of Computer-Presented Organizational/Memory Aids on Problem Solving Behavior.

ERIC Educational Resources Information Center

Steinberg, Esther R.; And Others

This research studied the effects of computer-presented organizational/memory aids on problem solving behavior. The aids were either matrix or verbal charts shown on the display screen next to the problem. The 104 college student subjects were randomly assigned to one of the four conditions: type of chart (matrix or verbal chart) and use of charts…

The Influence of Personalization of Online Texts on Elementary School Students' Reading Comprehension and Attitudes toward Reading

ERIC Educational Resources Information Center

Ertem, Ihsan Seyit

2013-01-01

The purpose of this research was to examine the role of personalized and non-personalized online texts on elementary school fifth grade students' comprehension and their attitudes toward reading. Participants were 47 fifth-grade students from a rural elementary school in north Florida. The subjects were randomly assigned into two (personalized…

Elaborative Talk during and after an Event: Conversational Style Influences Children's Memory Reports

ERIC Educational Resources Information Center

Hedrick, Amy M.; Haden, Catherine A.; Ornstein, Peter A.

2009-01-01

An experimental design was utilized to examine the effects of elaborative talk during and/or after an event on children's event memory reports. Sixty preschoolers were assigned randomly to one of four conditions that varied according to a researcher's use of high- or low- elaborative during- and/or post-event talk about a camping event. In a…

Employing Concept Mapping as a Pre-Writing Strategy to Help EFL Learners Better Generate Argumentative Compositions

ERIC Educational Resources Information Center

Al-Shaer, Ibrahim M. R.

2014-01-01

The purpose of this research was to examine the impact of employing concept mapping at a pre-writing stage on English as a foreign language (EFL) students' ability to generate better argumentative essays. Thirty-eight participants were randomly assigned to two groups participating in Writing II course at Al-Quds Open University (QOU). Both groups…

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

ERIC Educational Resources Information Center

Okyar, Hatice; Yangin Eksi, Gonca

2017-01-01

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

Teacher and Student Thoughts on Effectiveness of Cooperative Learning in Geography Teaching

ERIC Educational Resources Information Center

Kus, Metin; Filiz, Erkan; Altun, Sertel

2014-01-01

The aim of this study was to determine teachers' and students?' opinions on the effectiveness of cooperative learning. This study was conducted in Istanbul Lycee and it had a qualitative research design. The participant of the study assigned randomly among ninth grade students who were studying in Istanbul Lycee in the year of 2012 to 2013. Among…

Brief Report: Social Disability in Autism Spectrum Disorder--Results from Research Units on Pediatric Psychopharmacology (RUPP) Autism Network Trials

ERIC Educational Resources Information Center

Scahill, Lawrence; Hallett, Victoria; Aman, Michael G.; McDougle, Christopher J.; Arnold, L. Eugene; McCracken, James T.; Tierney, Elaine; Deng, Yanhong; Dziura, James; Vitiello, Benedetto

2013-01-01

There is growing interest in measuring social disability as a core element of autism spectrum disorders in medication trials. We conducted a secondary analysis on the Aberrant Behavior Checklist Social Withdrawal subscale using data from two federally-funded, multi-site, randomized trials with risperidone. Study 1 included 52 subjects assigned to…

Randomized control trial: Online parent program and waiting period for unmarried parents in Title IV-D court.

PubMed

Rudd, Brittany N; Holtzworth-Munroe, Amy; Reyome, Jason G; Applegate, Amy G; D'Onofrio, Brian M

2015-10-01

Despite a lack of research on parent education programs for unmarried parents, many judicial officers mandate participation. We recruited an understudied sample likely at high risk for negative outcomes-182 court cases involving unmarried parents on government assistance in which paternity was contested and then established via genetic testing ordered by the court. This 2 × 2 randomized controlled trial evaluated the impact on initial litigation outcomes of two factors: (a) participation in an online parent education program or not and (b) having a waiting period between the establishment of paternity and the court hearing concerning child-related issues or not. Using an intent-to-treat framework, we found that among cases not assigned to the program, there was no difference in the rate of full agreement on child-related issues (e.g., child support, custody, parenting time) when comparing cases assigned to a waiting period and cases not assigned to a waiting period. In contrast, for cases assigned to the program, cases also assigned a waiting period were less likely to reach a full agreement than cases that had their hearing on the same day. In addition, cases in the "program and waiting period" condition were less likely to return to court for their hearing than cases in the "no program and waiting period" condition. In exploratory analyses of the subsample of cases in which both parents were present at the court hearing, the pattern of results remained the same, although the findings were no longer statistically significant. (c) 2015 APA, all rights reserved).

Evaluation of a School-Based Teen Obesity Prevention Minimal Intervention

ERIC Educational Resources Information Center

Abood, Doris A.; Black, David R.; Coster, Daniel C.

2008-01-01

Objective: A school-based nutrition education minimal intervention (MI) was evaluated. Design: The design was experimental, with random assignment at the school level. Setting: Seven schools were randomly assigned as experimental, and 7 as delayed-treatment. Participants: The experimental group included 551 teens, and the delayed treatment group…

The Implications of "Contamination" for Experimental Design in Education

ERIC Educational Resources Information Center

Rhoads, Christopher H.

2011-01-01

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

Consequences of "Minimal" Group Affiliations in Children

ERIC Educational Resources Information Center

Dunham, Yarrow; Baron, Andrew Scott; Carey, Susan

2011-01-01

Three experiments (total N = 140) tested the hypothesis that 5-year-old children's membership in randomly assigned "minimal" groups would be sufficient to induce intergroup bias. Children were randomly assigned to groups and engaged in tasks involving judgments of unfamiliar in-group or out-group children. Despite an absence of information…

The Effect of Aggressive Cartoons: Children's Interpersonal Play.

ERIC Educational Resources Information Center

Hapkiewicz, Walter G.; Roden, Aubrey H.

Sixty second grade children were randomly assigned to same sex pairs and each pair was randomly assigned to one of three treatment groups: aggressive cartoon, nonaggressive cartoon, and no cartoon. Results indicated that there was no difference among the groups on measures of interpersonal aggression although boys exhibited significantly more…

Exploring the impact of positive and negative emotions on cooperative behaviour in a Prisoner’s Dilemma Game

PubMed Central

Thompson, Sam

2013-01-01

Objective. To explore the influences of discrete positive and negative emotions on cooperation in the context of a social dilemma game. Design. Two controlled studies were undertaken. In Study 1, 69 participants were randomly assigned to an essay emotion manipulation task designed to induce either guilt, joy or no strong emotion. In Study 2, 95 participants were randomly assigned to one of the same three tasks, and the impact of emotional condition on cooperation was explored using a repeated Prisoner’s Dilemma Game. Results. Study 1 established that the manipulation task was successful in inducing the specified emotions. The analysis from Study 2 revealed no significant main effects for emotions, in contrast to previous research. However, there was a significant effect for participants’ pre-existing tendency to cooperate (social value orientation; SVO). Conclusion. Methodological explanations for the result are explored, including the possible impact of trial-and-error strategies, different cooperation games and endogenous vs exogenous emotions. PMID:24432196

Exploring the impact of positive and negative emotions on cooperative behaviour in a Prisoner's Dilemma Game.

PubMed

Kjell, Oscar N E; Thompson, Sam

2013-12-19

Objective. To explore the influences of discrete positive and negative emotions on cooperation in the context of a social dilemma game. Design. Two controlled studies were undertaken. In Study 1, 69 participants were randomly assigned to an essay emotion manipulation task designed to induce either guilt, joy or no strong emotion. In Study 2, 95 participants were randomly assigned to one of the same three tasks, and the impact of emotional condition on cooperation was explored using a repeated Prisoner's Dilemma Game. Results. Study 1 established that the manipulation task was successful in inducing the specified emotions. The analysis from Study 2 revealed no significant main effects for emotions, in contrast to previous research. However, there was a significant effect for participants' pre-existing tendency to cooperate (social value orientation; SVO). Conclusion. Methodological explanations for the result are explored, including the possible impact of trial-and-error strategies, different cooperation games and endogenous vs exogenous emotions.

Effects of Students' Participation in Authoring of Multimedia Materials on Student Acquisition of Vocabulary.

ERIC Educational Resources Information Center

Nikolova, Ofelia R.

2002-01-01

Investigated the effects on vocabulary acquisition of student participation in authoring a multimedia institutional module. Sixty-two subjects were randomly assigned to two groups, and each group was randomly assigned to one of two treatments. Showed evidence that students learn vocabulary significantly better when they participate in the creation…

Random Assignment and Informed Consent: A Case Study of Multiple Perspectives

ERIC Educational Resources Information Center

Walker, Robert; Hoggart, Lesley; Hamilton, Gayle

2008-01-01

Although random assignment is generally the preferred methodology in impact evaluations, it raises numerous ethical concerns, some of which are addressed by securing participants' informed consent. However, there has been little investigation of how consent is obtained in social experiments and the amount of information that can be conveyed--and…

Does Autonomy over Teacher Hiring Affect Student Math and Science Achievement?

ERIC Educational Resources Information Center

Kim, Youngran

2017-01-01

This paper examines the causal effects of autonomy over teacher hiring on student math and science achievement using the random student assignment policy implemented in Korea. Under this policy, students were randomly assigned to different schools within their school districts which equalized the compositions of student bodies across schools.…

Representing "Us" and "Them": Building Blocks of Intergroup Cognition

ERIC Educational Resources Information Center

Baron, Andrew Scott; Dunham, Yarrow

2015-01-01

Three experiments explored whether group membership affects the acquisition of richer information about social groups. Employing a minimal-groups paradigm, 6- to 8-year-olds were randomly assigned to 1 of 2 novel social groups. Experiment 1 demonstrated that immediately following random assignment to a novel group, children were more likely to…

Entre Dos Mundos/Between Two Worlds: Youth Violence Prevention for Acculturating Latino Families

ERIC Educational Resources Information Center

Smokowski, Paul R.; Bacallao, Martica

2009-01-01

Objective: This study evaluated the efficacy of Entre Dos Mundos/Between Two Worlds (EDM) prevention for Latino adolescents. Method: In an experimental trial to compare implementation formats, 41 Latino families were randomly assigned to EDM action-oriented skills training groups, and 47 families were randomly assigned to unstructured EDM support…

One-Year Outcomes of a Randomized Clinical Trial Treating Depression in Low-Income Minority Women

ERIC Educational Resources Information Center

Miranda, Jeanne; Green, Bonnie L.; Krupnick, Janice L.; Chung, Joyce; Siddique, Juned; Belin, Tom; Revicki, Dennis

2006-01-01

This study examines 1-year depressive symptom and functional outcomes of 267 predominantly low-income, young minority women randomly assigned to antidepressant medication, group or individual cognitive-behavioral therapy (CBT), or community referral. Seventy-six percent assigned to medications received 9 or more weeks of guideline-concordant doses…

Effects of an Early Numeracy Intervention on Struggling Kindergarteners' Mathematics Performance

ERIC Educational Resources Information Center

Bryant, Brian R.; Bryant, Diane Pedrotty; Roberts, Greg; Fall, Anna-Maria

2016-01-01

The purpose of this study was to investigate the effects of an early numeracy intervention delivered by kindergarten teachers to students identified as having mathematics difficulties. A multigroup growth-modeling-with-random-assignment-to-intervention-condition design was employed. Thirty-two teachers were randomly assigned to the treatment or…

75 FR 69126 - Proposed Information Collection Request (ICR) for the Workforce Investment Act Random Assignment...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-10

... Random Assignment Impact Evaluation of the Adult and Dislocated Worker Program; Comment Request AGENCY... fragmented system of employment and training programs under JTPA and providing universal access to basic (core) services. To determine whether the adult and dislocated worker services funded by Title I of the...

Auditing the Assignments of Top-Level Semantic Types in the UMLS Semantic Network to UMLS Concepts

PubMed Central

He, Zhe; Perl, Yehoshua; Elhanan, Gai; Chen, Yan; Geller, James; Bian, Jiang

2018-01-01

The Unified Medical Language System (UMLS) is an important terminological system. By the policy of its curators, each concept of the UMLS should be assigned the most specific Semantic Types (STs) in the UMLS Semantic Network (SN). Hence, the Semantic Types of most UMLS concepts are assigned at or near the bottom (leaves) of the UMLS Semantic Network. While most ST assignments are correct, some errors do occur. Therefore, Quality Assurance efforts of UMLS curators for ST assignments should concentrate on automatically detected sets of UMLS concepts with higher error rates than random sets. In this paper, we investigate the assignments of top-level semantic types in the UMLS semantic network to concepts, identify potential erroneous assignments, define four categories of errors, and thus provide assistance to curators of the UMLS to avoid these assignments errors. Human experts analyzed samples of concepts assigned 10 of the top-level semantic types and categorized the erroneous ST assignments into these four logical categories. Two thirds of the concepts assigned these 10 top-level semantic types are erroneous. Our results demonstrate that reviewing top-level semantic type assignments to concepts provides an effective way for UMLS quality assurance, comparing to reviewing a random selection of semantic type assignments. PMID:29375930

Auditing the Assignments of Top-Level Semantic Types in the UMLS Semantic Network to UMLS Concepts.

PubMed

He, Zhe; Perl, Yehoshua; Elhanan, Gai; Chen, Yan; Geller, James; Bian, Jiang

2017-11-01

The Unified Medical Language System (UMLS) is an important terminological system. By the policy of its curators, each concept of the UMLS should be assigned the most specific Semantic Types (STs) in the UMLS Semantic Network (SN). Hence, the Semantic Types of most UMLS concepts are assigned at or near the bottom (leaves) of the UMLS Semantic Network. While most ST assignments are correct, some errors do occur. Therefore, Quality Assurance efforts of UMLS curators for ST assignments should concentrate on automatically detected sets of UMLS concepts with higher error rates than random sets. In this paper, we investigate the assignments of top-level semantic types in the UMLS semantic network to concepts, identify potential erroneous assignments, define four categories of errors, and thus provide assistance to curators of the UMLS to avoid these assignments errors. Human experts analyzed samples of concepts assigned 10 of the top-level semantic types and categorized the erroneous ST assignments into these four logical categories. Two thirds of the concepts assigned these 10 top-level semantic types are erroneous. Our results demonstrate that reviewing top-level semantic type assignments to concepts provides an effective way for UMLS quality assurance, comparing to reviewing a random selection of semantic type assignments.

The impact of rehabilitation and counseling services on the labor market activity of Social Security Disability Insurance (SSDI) beneficiaries.

PubMed

Weathers, Robert R; Bailey, Michelle Stegman

2014-01-01

We use data from a social experiment to estimate the impact of a rehabilitation and counseling program on the labor market activity of newly entitled Social Security Disability Insurance (SSDI) beneficiaries. Our results indicate that the program led to a 4.6 percentage point increase in the receipt of employment services within the first year following random assignment and a 5.1 percentage point increase in participation in the Social Security Administration's Ticket to Work program within the first three years following random assignment. The program led to a 5.3 percentage point increase, or almost 50 percent increase, in employment, and an $831 increase in annual earnings in the second calendar year after the calendar year of random assignment. The employment and earnings impacts are smaller and not statistically significant in the third calendar year following random assignment, and we describe SSDI rules that are consistent with this finding. Our findings indicate that disability reform proposals focusing on restoring the work capacity of people with disabilities can increase the disability employment rate.

Comparison of topical ropivacaine with and without ketamine on post-surgical pain in children undergoing tonsillectomy: a randomized controlled double-blind study.

PubMed

Hong, Boohwi; Lim, Chae Seong; Kim, Yoon-Hee; Lee, Jung Un; Kim, Yong Min; Jung, Choonho; Jo, Yumin

2017-08-01

Tonsillectomy in pediatric patients may cause severe postoperative pain. Topical local anesthetics are an easy and safe way to control post-tonsillectomy pain, but there is no benefit during the early postoperative stage. Topical ketamine shows a good effect on early stage postoperative pain. We compared the effect of topical ropivacaine with and without ketamine on post-tonsillectomy pain. Patients aged 3-7 years undergoing tonsillectomy were selected to participate in the study. Our study was performed in a randomized, placebo-controlled, double-blind manner. Patients were randomly assigned to one of two groups using computer-generated random numbers. The researchers who assessed the pain score, the caregivers, and the patient were blinded to group assignment. One group received topical ropivacaine with saline (RS group) and the other group received topical ropivacaine with 20 mg ketamine (RK group) on the tonsillar bed. Pain scores using the modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS) at 15 min and 30 min, and at 1, 2, 4, 8, 16 and 24 h were recorded. Rescue analgesic requirement and complications were also recorded. A total of 66 patients were randomly assigned to the RS group (n = 33) and the RK group (n = 33). The mCHEOPS scores were significantly lower in the RK group at 15 min (P = 0.046). The mCHEOPS scores of the two groups decreased with time, but there was no intergroup interaction. The RS group received more analgesics until 1 h after surgery and the RK group received more analgesics during 1-24 h after surgery. There were no differences in adverse outcomes. Topical ropivacaine with ketamine can reduce immediate postoperative pain and analgesic requirement better than ropivacaine alone.

WWC Review of the Report "Increasing Young Children's Contact with Print during Shared Reading: Longitudinal Effects on Literacy Achievement"

ERIC Educational Resources Information Center

What Works Clearinghouse, 2012

2012-01-01

The study examined the impact of the "Project STAR" ("Sit Together and Read") reading program on the literacy skills of preschool students. Researchers randomly assigned 85 preschool classrooms in Ohio to one of three study groups at the start of the 2004-05 or 2005-06 school years: (1) A high-dose intervention group, in which…

Preliminary Testing of a Program to Prevent Type 2 Diabetes among High-Risk Youth.(research Papers)

ERIC Educational Resources Information Center

Grey, Margaret; Berry, Diane; Davidson, Maryanne; Galasso, Pam; Gustafson, Elaine; Melkus, Gail

2004-01-01

Type 2 diabetes is increasing among youth, with minority youth at highest risk. This preliminary study tested the feasibility of a school-based program to prevent type 2 diabetes in youth at risk. Forty-one participants (age 12.6 [+ or -] 1.1 years; 63% female, 51% African American, 44% Hispanic, and 5% Caucasian) were randomly assigned to one of…

An Investigation of the Effects of the Use of SmartMusic Software by Brass Players on Intonation and Rhythmic Accuracy

ERIC Educational Resources Information Center

Flanigan, Glen Patrick

2008-01-01

The purpose of the present research study was to examine effects of the use of SmartMusic practice software on the intonation and rhythmic accuracy of brass players' musical performances. Twenty college brass players who served as participants in the four-week study were randomly assigned to one of two practice conditions. The WSM (With…

Comparison of Cognitive Behavioral and Mindfulness Meditation Interventions on Adaptation to Rheumatoid Arthritis for Patients with and without History of Recurrent Depression

ERIC Educational Resources Information Center

Zautra, Alex J.; Davis, Mary C.; Reich, John W.; Nicassio, Perry; Tennen, Howard; Finan, Patrick; Kratz, Anna; Parrish, Brendt; Irwin, Michael R.

2008-01-01

This research examined whether cognitive behavioral therapy and mindfulness interventions that target responses to chronic stress, pain, and depression reduce pain and improve the quality of everyday life for adults with rheumatoid arthritis (RA). The 144 RA participants were clustered into groups of 6-10 participants and randomly assigned to 1 of…

Foster care's youngest: a preliminary report.

PubMed

Klee, L; Kronstadt, D; Zlotnick, C

1997-04-01

The impact of welfare reform on foster care is examined in relation to children's mental health. Initial assessment of 125 young foster children randomly assigned to a special program found that half rated below normal on mental and psychomotor development, with two-thirds below normal on emotional regulation and motor quality. Implications for social policy and program planning, and the need for ongoing research, are discussed.

Does Teaching Mnemonics for Vocabulary Learning Make a Difference? Putting the Keyword Method and the Word Part Technique to the Test

ERIC Educational Resources Information Center

Wei, Zheng

2015-01-01

The present research tested the effectiveness of the word part technique in comparison with the keyword method and self-strategy learning. One hundred and twenty-one Chinese year-one university students were randomly assigned to one of the three learning conditions: word part, keyword or self-strategy learning condition. Half of the target words…

Finding Order and Direction from Chaos: A Comparison of Chaos Career Counseling and Trait Matching Counseling

ERIC Educational Resources Information Center

McKay, Hannah; Bright, Jim E. H.; Pryor, Robert G. L.

2005-01-01

Chaos career counseling, based on the Chaos Theory of Careers (R. G. L. Pryor & J. E. H. Bright, 2003a, 2003b), was compared with trait matching career counseling and a wait list control. Sixty university students who attended the Careers Research and Assessment Service seeking career advice were randomly assigned to the chaos intervention, the…

Training Mispronunciation Correction and Word Meanings Improves Children's Ability to Learn to Read Words

ERIC Educational Resources Information Center

Dyson, Hannah; Best, Wendy; Solity, Jonathan; Hulme, Charles

2017-01-01

Previous research has suggested that learning to read irregular words depends upon knowledge of a word's meaning and the ability to correct imperfect decoding attempts by reference to the known pronunciations of a word. In an experimental training study, 84 children ages 5-7 years were randomly assigned to an intervention or control group.…

Responsiveness and Attention during Picture-Book Reading in 18-Month-Old to 24-Month-Old Toddlers at Risk

ERIC Educational Resources Information Center

Fletcher, Kathryn L.; Perez, Andreina; Hooper, Corrie; Claussen, Angelika H.

2005-01-01

The purpose of this research was to examine the spontaneous responsiveness and attention during picture-book reading in 18-month-old to 24-month-old children from at-risk backgrounds. Twenty-five, 18-month-old children in an early intervention program were randomly assigned to a read condition or play condition for six months. At each seventh…

An Evaluation of Three Methods of Racism-Sexism Training in a University Student Orientation Program. Research Report No. 1-75.

ERIC Educational Resources Information Center

Troy, Warwick G.; And Others

Three types of workshops dealing with racism and sexism were conducted for 1900 incoming university freshmen as part of their orientation program. The methods were a structured discussion model developed by Sedlacek and Brooks (1976), a Starpower simulation workshop, and a movie discussion group. Students were randomly assigned to one of the three…

Is It Live or Is It Internet? Experimental Estimates of the Effects of Online Instruction on Student Learning. NBER Working Paper No. 16089

ERIC Educational Resources Information Center

Figlio, David N.; Rush, Mark; Yin, Lu

2010-01-01

This paper presents the first experimental evidence on the effects of live versus internet media of instruction. Students in a large introductory microeconomics course at a major research university were randomly assigned to live lectures versus watching these same lectures in an internet setting, where all other factors (e.g., instruction,…

Randomized controlled trial of ethyl-eicosapentaenoic acid in Huntington disease: the TREND-HD study.

PubMed

2008-12-01

To determine whether ethyl-eicosapentaenoic acid (ethyl-EPA), an omega-3 fatty acid, improves the motor features of Huntington disease. Six-month multicenter, randomized, double-blind, placebo-controlled trial followed by a 6-month open-label phase without disclosing initial treatment assignments. Forty-one research sites in the United States and Canada. Three hundred sixteen adults with Huntington disease, enriched for a population with shorter trinucleotide (cytosine-adenine-guanine) repeat length expansions. Random assignment to placebo or ethyl-EPA, 1 g twice a day, followed by open-label treatment with ethyl-EPA. Six-month change in the Total Motor Score 4 component of the Unified Huntington's Disease Rating Scale analyzed for all research participants and those with shorter cytosine-adenine-guanine repeat length expansions (<45). At 6 months, the Total Motor Score 4 point change for patients receiving ethyl-EPA did not differ from that for those receiving placebo. No differences were found in measures of function, cognition, or global impression. Before public disclosure of the 6-month placebo-controlled results, 192 individuals completed the open-label phase. The Total Motor Score 4 change did not worsen for those who received active treatment for 12 continuous months compared with those who received active treatment for only 6 months (2.0-point worsening; P=.02). Ethyl-EPA was not beneficial in patients with Huntington disease during 6 months of placebo-controlled evaluation. Clinical Trial Registry clinicaltrials.gov Identifier: NCT00146211.

Randomized, Prospective Study of the Impact of a Sleep Health Program on Firefighter Injury and Disability.

PubMed

Sullivan, Jason P; O'Brien, Conor S; Barger, Laura K; Rajaratnam, Shantha M W; Czeisler, Charles A; Lockley, Steven W

2017-01-01

Firefighters' schedules include extended shifts and long work weeks which cause sleep deficiency and circadian rhythm disruption. Many firefighters also suffer from undiagnosed sleep disorders, exacerbating fatigue. We tested the hypothesis that a workplace-based Sleep Health Program (SHP) incorporating sleep health education and sleep disorders screening would improve firefighter health and safety compared to standard practice. Prospective station-level randomized, field-based intervention. US fire department. 1189 firefighters. Sleep health education, questionnaire-based sleep disorders screening, and sleep clinic referrals for respondents who screened positive for a sleep disorder. Firefighters were randomized by station. Using departmental records, in an intention-to-treat analysis, firefighters assigned to intervention stations which participated in education sessions and had the opportunity to complete sleep disorders screening reported 46% fewer disability days than those assigned to control stations (1.4 ± 5.9 vs. 2.6 ± 8.5 days/firefighter, respectively; p = .003). There were no significant differences in departmental injury or motor vehicle crash rates between the groups. In post hoc analysis accounting for intervention exposure, firefighters who attended education sessions were 24% less likely to file at least one injury report during the study than those who did not attend, regardless of randomization (OR [95% CI] 0.76 [0.60, 0.98]; χ2 = 4.56; p = .033). There were no significant changes pre- versus post-study in self-reported sleep or sleepiness in those who participated in the intervention. A firefighter workplace-based SHP providing sleep health education and sleep disorders screening opportunity can reduce injuries and work loss due to disability in firefighters. © Sleep Research Society 2016. Published by Oxford University Press on behalf of the Sleep Research Society. All rights reserved. For permissions, please e-mail journals.permissions@oup.com.

Maternal education preferences moderate the effects of mandatory employment and education programs on child positive and problem behaviors.

PubMed

Gassman-Pines, Anna; Godfrey, Erin B; Yoshikawa, Hirokazu

2013-01-01

Grounded in person-environment fit theory, this study examined whether low-income mothers' preferences for education moderated the effects of employment- and education-focused welfare programs on children's positive and problem behaviors. The sample included 1,365 families with children between ages 3 and 5 years at study entry. Results 5 years after random assignment, when children were ages 8-10 years, indicated that mothers' education preferences did moderate program impacts on teacher-reported child behavior problems and positive behavior. Children whose mothers were assigned to the education program were rated by teachers to have less externalizing behavior and more positive behavior than children whose mothers were assigned to the employment program but only when mothers had strong preferences for education. © 2012 The Authors. Child Development © 2012 Society for Research in Child Development, Inc.

Skeletal Health After Continuation, Withdrawal, or Delay of Alendronate in Men With Prostate Cancer Undergoing Androgen-Deprivation Therapy

PubMed Central

Greenspan, Susan L.; Nelson, Joel B.; Trump, Donald L.; Wagner, Julie M.; Miller, Megan E.; Perera, Subashan; Resnick, Neil M.

2008-01-01

Purpose Androgen-deprivation therapy (ADT) for prostate cancer is associated with bone loss and osteoporotic fractures. Our objective was to examine changes in bone density and turnover with sustained, discontinued, or delayed oral bisphosphonate therapy in men receiving ADT. Patients and Methods A total of 112 men with nonmetastatic prostate cancer receiving ADT were randomly assigned to alendronate 70 mg once weekly or placebo in a double-blind, partial-crossover trial with a second random assignment at year 2 for those who initially received active therapy. Outcomes included bone mineral density and bone turnover markers. Results Men initially randomly assigned to alendronate and randomly reassigned at year 2 to continue had additional bone density gains at the spine (mean, 2.3% ± 0.7) and hip (mean, 1.3% ± 0.5%; both P < .01); those randomly assigned to placebo in year 2 maintained density at the spine and hip but lost (mean, −1.9% ± 0.6%; P < .01) at the forearm. Patients randomly assigned to begin alendronate in year 2 experienced improvements in bone mass at the spine and hip, but experienced less of an increase compared with those who initiated alendronate at baseline. Men receiving alendronate for 2 years experienced a mean 6.7% (± 1.2%) increase at the spine and a 3.2% (± 1.5%) at the hip (both P < .05). Bone turnover remained suppressed. Conclusion Among men with nonmetastatic prostate cancer receiving ADT, once-weekly alendronate improves bone density and decreases turnover. A second year of alendronate provides additional skeletal benefit, whereas discontinuation results in bone loss and increased bone turnover. Delay in bisphosphonate therapy appears detrimental to bone health. PMID:18802155

Repeated Reading Intervention: Outcomes and Interactions with Readers' Skills and Classroom Instruction

ERIC Educational Resources Information Center

Vadasy, Patricia F.; Sanders, Elizabeth A.

2008-01-01

This study examined effects of a repeated reading intervention, Quick Reads, with incidental word-level scaffolding instruction. Second- and third-grade students with passage-reading fluency performance between the 10th and 60th percentiles were randomly assigned to dyads, which were in turn randomly assigned to treatment (paired tutoring, n = 82)…

Randomized Sequential Individual Assignment in Social Experiments: Evaluating the Design Options Prospectively

ERIC Educational Resources Information Center

Lohr, Sharon L.; Zhu, Xiaoshu

2017-01-01

Many randomized experiments in the social sciences allocate subjects to treatment arms at the time the subjects enroll. Desirable features of the mechanism used to assign subjects to treatment arms are often (1) equal numbers of subjects in intervention and control arms, (2) balanced allocation for population subgroups and across covariates, (3)…

The Effect of Realistic Versus Imaginary Aggressive Models of Children's Interpersonal Play

ERIC Educational Resources Information Center

Hapkiewicz, Walter G.; Stone, Robert D.

1974-01-01

One hundred eighty elementary school children were randomly assigned to same sex pairs and randomly assigned to one of three treatment groups: real-life aggressive film, aggressive cartoon, or nonaggressive film. Results reveal that boys who viewed the realistic aggressive film were significantly more aggressive in play than boys who viewed the…

WWC Review of the Report "Effects of Problem Based Economics on High School Economics Instruction"

ERIC Educational Resources Information Center

What Works Clearinghouse, 2012

2012-01-01

The study described in this report included 128 high school economics teachers from 106 schools in Arizona and California, half of whom were randomly assigned to the "Problem Based Economics Instruction" condition and half of whom were randomly assigned to the comparison condition. High levels of teacher attrition occurred after…

The Social Security Administration's Youth Transition Demonstration Projects: Implementation Lessons from the Original Projects

ERIC Educational Resources Information Center

Martinez, John; Fraker, Thomas; Manno, Michelle; Baird, Peter; Mamun, Arif; O'Day, Bonnie; Rangarajan, Anu; Wittenburg, David

2010-01-01

This report focuses on the seven original Youth Transition Demonstration (YTD) projects selected for funding in 2003. Three of the original seven projects were selected for a national random assignment evaluation in 2005; however, this report only focuses on program operations prior to joining the random assignment evaluation for the three…

PROMOTING SUPPORTIVE PARENTING IN NEW MOTHERS WITH SUBSTANCE-USE PROBLEMS: A PILOT RANDOMIZED TRIAL OF RESIDENTIAL TREATMENT PLUS AN ATTACHMENT-BASED PARENTING PROGRAM

PubMed Central

BERLIN, LISA J.; SHANAHAN, MEGHAN; CARMODY, KAREN APPLEYARD

2015-01-01

This pilot randomized trial tested the feasibility and efficacy of supplementing residential substance-abuse treatment for new mothers with a brief, yet rigorous, attachment-based parenting program. Twenty-one predominantly (86%) White mothers and their infants living together in residential substance-abuse treatment were randomly assigned to the program (n = 11) or control (n = 10) group. Program mothers received 10 home-based sessions of Dozier’s Attachment and Biobehavioral Catch-up (ABC) intervention. Postintervention observations revealed more supportive parenting behaviors among the randomly assigned ABC mothers. PMID:25424409

Building research capacity in Botswana: a randomized trial comparing training methodologies in the Botswana ethics training initiative.

PubMed

Barchi, Francis H; Kasimatis-Singleton, Megan; Kasule, Mary; Khulumani, Pilate; Merz, Jon F

2013-02-01

Little empirical data are available on the extent to which capacity-building programs in research ethics prepare trainees to apply ethical reasoning skills to the design, conduct, or review of research. A randomized controlled trial was conducted in Botswana in 2010 to assess the effectiveness of a case-based intervention using email to augment in-person seminars. University faculty and current and prospective IRB/REC members took part in a semester-long training program in research ethics. Participants attended two 2-day seminars and were assigned at random to one of two on-line arms of the trial. Participants in both arms completed on-line international modules from the Collaborative Institutional Training Initiative. Between seminars, intervention-arm participants were also emailed a weekly case to analyze in response to set questions; responses and individualized faculty feedback were exchanged via email. Tests assessing ethics knowledge were administered at the start of each seminar. The post-test included an additional section in which participants were asked to identify the ethical issues highlighted in five case studies from a list of multiple-choice responses. Results were analyzed using regression and ANOVA. Of the 71 participants (36 control, 35 intervention) enrolled at the first seminar, 41 (57.7%) attended the second seminar (19 control, 22 intervention). In the intervention arm, 19 (54.3%) participants fully completed and 8 (22.9%) partially completed all six weekly cases. The mean score was higher on the post-test (30.3/40) than on the pre-test (28.0/40), and individual post- and pre-test scores were highly correlated (r = 0.65, p < 0.0001). Group assignment alone did not have an effect on test scores (p > 0.84), but intervention-arm subjects who completed all assigned cases answered an average of 3.2 more questions correctly on the post-test than others, controlling for pre-test scores (p = 0.003). Completion of the case-based intervention improved respondents' test scores, with those who completed all six email cases scoring roughly 10% better than those who failed to complete this task and those in the control arm. There was only suggestive evidence that intensive case work improved ethical issue identification, although there was limited ability to assess this outcome due to a high drop-out rate.

Building research capacity in Botswana: a randomized trial comparing training methodologies in the Botswana ethics training initiative

PubMed Central

2013-01-01

Background Little empirical data are available on the extent to which capacity-building programs in research ethics prepare trainees to apply ethical reasoning skills to the design, conduct, or review of research. A randomized controlled trial was conducted in Botswana in 2010 to assess the effectiveness of a case-based intervention using email to augment in-person seminars. Methods University faculty and current and prospective IRB/REC members took part in a semester-long training program in research ethics. Participants attended two 2-day seminars and were assigned at random to one of two on-line arms of the trial. Participants in both arms completed on-line international modules from the Collaborative Institutional Training Initiative. Between seminars, intervention-arm participants were also emailed a weekly case to analyze in response to set questions; responses and individualized faculty feedback were exchanged via email. Tests assessing ethics knowledge were administered at the start of each seminar. The post-test included an additional section in which participants were asked to identify the ethical issues highlighted in five case studies from a list of multiple-choice responses. Results were analyzed using regression and ANOVA. Results Of the 71 participants (36 control, 35 intervention) enrolled at the first seminar, 41 (57.7%) attended the second seminar (19 control, 22 intervention). In the intervention arm, 19 (54.3%) participants fully completed and 8 (22.9%) partially completed all six weekly cases. The mean score was higher on the post-test (30.3/40) than on the pre-test (28.0/40), and individual post- and pre-test scores were highly correlated (r = 0.65, p < 0.0001). Group assignment alone did not have an effect on test scores (p > 0.84), but intervention-arm subjects who completed all assigned cases answered an average of 3.2 more questions correctly on the post-test than others, controlling for pre-test scores (p = 0.003). Conclusions Completion of the case-based intervention improved respondents’ test scores, with those who completed all six email cases scoring roughly 10% better than those who failed to complete this task and those in the control arm. There was only suggestive evidence that intensive case work improved ethical issue identification, although there was limited ability to assess this outcome due to a high drop-out rate. PMID:23368699

The Effect of Patient Choice of Intervention on Health Outcomes

PubMed Central

Clark, Noreen M.; Janz, Nancy K.; Dodge, Julia A.; Mosca, Lori; Lin, Xihong; Long, Qi; Little, Roderick J; Wheeler, John R.C.; Keteyian, Steven; Liang, Jersey

2008-01-01

Background Patient preference may influence intervention effects, but has not been extensively studied. Randomized controlled design (N=1075) assessed outcomes when women (60 years +) were given a choice of two formats of a program to enhance heart disease management. Methods Randomization to "no choice" or "choice" study arms. Further randomization of "no choice” to: 1) Group intervention program format, 2) Self-Directed program format, 3) Control Group. "Choice" arm selected their preferred program format. Baseline, four, twelve, and eighteen month follow-up data collected. Two analyses: health outcomes for choice compared to being randomized; and preference effect on treatment efficacy. Results Women who chose a format compared to being assigned a format had better psychosocial functioning at four months (p=0.02) and tended toward better physical functioning at twelve months (p=0.07). At eighteen months women who chose versus being assigned a format had more symptoms measured as: number (p=0.004), frequency (p=0.006) and bother (p=0.004). At four months women who preferred the Group format had better psychosocial functioning when assigned the Group format than when they were assigned the Self Directed format (p=0.03). At eighteen months women preferring a Group format had more symptoms: number (p=0.001), frequency (p=0.001), bother (p=0.001) when assigned the Group format than when assigned the Self Directed format. Conclusions Choice and preference for the Group format each enhanced psychosocial and physical functioning up to one year. Despite the preference for Group format, over the longer term (eighteen months) cardiac symptoms were fewer when assigned the Self-Directed format. PMID:18515187

Evaluation of a brief aerobic exercise intervention for high anxiety sensitivity.

PubMed

Broman-Fulks, Joshua J; Storey, Katelyn M

2008-04-01

Anxiety sensitivity, or the belief that anxiety-related sensations can have negative consequences, has been shown to play an important role in the etiology and maintenance of panic disorder and other anxiety-related pathology. Aerobic exercise involves exposure to physiological cues similar to those experienced during anxiety reactions. The present study sought to investigate the efficacy of a brief aerobic exercise intervention for high anxiety sensitivity. Accordingly, 24 participants with high anxiety sensitivity scores (Anxiety Sensitivity Index-Revised scores >28) were randomly assigned to complete either six 20-minute sessions of aerobic exercise or a no-exercise control condition. The results indicated that individuals assigned to the aerobic exercise condition reported significantly less anxiety sensitivity subsequent to exercise, whereas anxiety sensitivity scores among non-exercisers did not significantly change. The clinical research and public health implications of these findings are discussed, and several potential directions for additional research are recommended.

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

PubMed Central

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

2015-01-01

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

Specifying a target trial prevents immortal time bias and other self-inflicted injuries in observational analyses

PubMed Central

Hernán, Miguel A.; Sauer, Brian C.; Hernández-Díaz, Sonia; Platt, Robert; Shrier, Ian

2016-01-01

Many analyses of observational data are attempts to emulate a target trial. The emulation of the target trial may fail when researchers deviate from simple principles that guide the design and analysis of randomized experiments. We review a framework to describe and prevent biases, including immortal time bias, that result from a failure to align start of follow-up, specification of eligibility, and treatment assignment. We review some analytic approaches to avoid these problems in comparative effectiveness or safety research. PMID:27237061

Endogenous risk-taking and physical appearance of sex workers.

PubMed

Egger, Peter H; Lindenblatt, Andreas

2015-12-01

Previous research found that physical appearance affects the risk-taking of sex workers through offering unprotected services. This paper utilizes a large individual-level data set covering 16,583 pay-for-sex contracts in 2011 and 2012 by 2,517 female suppliers in Germany. Results based on instrumental variables suggest that the incentive for risk-taking is about twice as high than when assuming random assignment of risk-taking.

Facilitating Positive Psychosocial Adaptation in Children with Cystic Fibrosis by Increasing Family Communication and Problem-Solving Skills. A Research Report to the Cystic Fibrosis Foundation.

ERIC Educational Resources Information Center

Stabler, Brian; And Others

This study tested the effects of two group-oriented supportive and educational approaches on the parents of children with cystic fibrosis (CF). Thirteen families were randomly assigned either to a group which received information on medical and technical aspects of CF or to a group which received instruction in communication skills in addition to…

Music Activities as a Meaningful Context for Teaching Elementary Students Mathematics: A Quasi-Experiment Time Series Design with Random Assigned Control Group

ERIC Educational Resources Information Center

An, Song A.; Tillman, Daniel A.

2015-01-01

The purpose of the current research was to examine the effects of a sequence of classroom activities that integrated mathematics content with music elements aimed at providing teachers an alternative approach for teaching mathematics. Two classes of third grade students (n = 56) from an elementary school in the west coast of the United States…

Community vs. Clinic-Based Modular Treatment of Children with Early-Onset ODD or CD: A Clinical Trial with 3-Year Follow-Up

ERIC Educational Resources Information Center

Kolko, David J.; Dorn, Lorah D.; Bukstein, Oscar G.; Pardini, Dustin; Holden, Elizabeth A.; Hart, Jonathan

2009-01-01

This study examines the treatment outcomes of 139, 6-11 year-old, clinically referred boys and girls diagnosed with Oppositional Defiant Disorder (ODD) or Conduct Disorder (CD) who were randomly assigned to a modular-based treatment protocol that was applied by research study clinicians either in the community (COMM) or a clinic office (CLINIC).…

Using Place-Based Random Assignment and Comparative Interrupted Time-Series Analysis To Evaluate the Jobs-Plus Employment Program for Public Housing Residents.

ERIC Educational Resources Information Center

Bloom, Howard S.; Rico, James A.

This paper describes a place-based research demonstration program to promote and sustain employment among residents of selected public housing developments in U.S. cities. Because all eligible residents of the participating public housing developments were free to take part in the program, it was not possible to study its impacts in a classical…

Estimating Impacts of Treatment Random Assignment on Classroom Quality in the Head Start Impact Study: The Problem of Missing Data

ERIC Educational Resources Information Center

Friedman-Krauss, Allison H.; Connors, Maia C.; Morris, Pamela A.

2013-01-01

As a result of the 1998 reauthorization of Head Start, the Department of Health and Human Services conducted a national evaluation of the Head Start program. The goal of Head Start is to improve the school readiness skills of low-income children in the United States. There is a substantial body of experimental and correlational research that has…

The Effects of Cardio-Syntactic Analysis Instruction on Writing Scores in a 11th Grade High School Classroom

ERIC Educational Resources Information Center

Kariuki, Patrick N.; Blair, Paul W.

2015-01-01

The purpose of this research was to determine the effects of Cardio-Syntactic Analysis instruction on writing scores in an 11th grade English class. The sample consisted of 35 students enrolled in an Honor's English 11 class at Volunteer high School, in Church Hill, TN. The class was randomly assigned into an experimental group of 17 students and…

Perceptions of Domestic Violence: The Effects of Domestic Violence Myths, Victim's Relationship with Her Abuser, and the Decision to Return to Her Abuser

ERIC Educational Resources Information Center

Yamawaki, Niwako; Ochoa-Shipp, Monica; Pulsipher, Craig; Harlos, Andrew; Swindler, Scott

2012-01-01

Researchers in this study examined the attitudes toward domestic violence, the victim, and her perpetrator. A total of 194 participants were randomly assigned to one of 4 hypothetical scenarios to evaluate how observers' perceptions were influenced by their own sex and myths about domestic violence, by the victim's decision to return to the…

A Study Investigating the Effect of Treatment Developed by Integrating the 5E and Simulation on Pre-Service Science Teachers' Achievement in Photoelectric Effect

ERIC Educational Resources Information Center

Taslidere, Erdal

2015-01-01

The Current study investigated the effect of the 5E learning cycle in which the simulations were integrated on pre-service science teachers' achievement in photoelectric subject. Four sophomore level classes with their 140 students participated in the research and a quasi-experimental design was used. The classes were randomly assigned into one of…

Effects of Individualized and Standardized Interventions on Middle School Students With Reading Disabilities

PubMed Central

VAUGHN, SHARON; WEXLER, JADE; ROBERTS, GREG; BARTH, AMY A.; CIRINO, PAUL T.; ROMAIN, MELISSA A.; FRANCIS, DAVID; FLETCHER, JACK; DENTON, CAROLYN A.

2011-01-01

This study reports the effectiveness of a year-long, small-group, tertiary (Tier 3) intervention that examined 2 empirically derived but conceptually different treatments and a comparison condition. The researchers had randomly assigned all students to treatment or comparison conditions. The participants were seventh- and eighth-grade students from the previous year who received an intervention and did not meet exit criteria. The researchers assigned them to one of two treatments: standardized (n = 69) or individualized (n = 71) for 50 min a day, in group sizes of 5, for the entire school year. Comparison students received no researcher-provided intervention (n = 42). The researchers used multigroup modeling with nested comparisons to evaluate the statistical significance of Time 3 estimates. Students in both treatments outperformed the comparison students on assessments of decoding, fluency, and comprehension. Intervention type did not moderate the pattern of effects, although students in the standardized treatment had a small advantage over individualized students on word attack. This study provides a framework from which to refine further interventions for older students with reading disabilities. PMID:23125463

Prediction of aquatic toxicity mode of action using linear discriminant and random forest models.

PubMed

Martin, Todd M; Grulke, Christopher M; Young, Douglas M; Russom, Christine L; Wang, Nina Y; Jackson, Crystal R; Barron, Mace G

2013-09-23

The ability to determine the mode of action (MOA) for a diverse group of chemicals is a critical part of ecological risk assessment and chemical regulation. However, existing MOA assignment approaches in ecotoxicology have been limited to a relatively few MOAs, have high uncertainty, or rely on professional judgment. In this study, machine based learning algorithms (linear discriminant analysis and random forest) were used to develop models for assigning aquatic toxicity MOA. These methods were selected since they have been shown to be able to correlate diverse data sets and provide an indication of the most important descriptors. A data set of MOA assignments for 924 chemicals was developed using a combination of high confidence assignments, international consensus classifications, ASTER (ASessment Tools for the Evaluation of Risk) predictions, and weight of evidence professional judgment based an assessment of structure and literature information. The overall data set was randomly divided into a training set (75%) and a validation set (25%) and then used to develop linear discriminant analysis (LDA) and random forest (RF) MOA assignment models. The LDA and RF models had high internal concordance and specificity and were able to produce overall prediction accuracies ranging from 84.5 to 87.7% for the validation set. These results demonstrate that computational chemistry approaches can be used to determine the acute toxicity MOAs across a large range of structures and mechanisms.

A study of the effects of gender and different instructional media (computer-assisted instruction tutorials vs. textbook) on student attitudes and achievement in a team-taught integrated science class

NASA Astrophysics Data System (ADS)

Eardley, Julie Anne

The purpose of this study was to determine the effect of different instructional media (computer assisted instruction (CAI) tutorial vs. traditional textbook) on student attitudes toward science and computers and achievement scores in a team-taught integrated science course, ENS 1001, "The Whole Earth Course," which was offered at Florida Institute of Technology during the Fall 2000 term. The effect of gender on student attitudes toward science and computers and achievement scores was also investigated. This study employed a randomized pretest-posttest control group experimental research design with a sample of 30 students (12 males and 18 females). Students had registered for weekly lab sessions that accompanied the course and had been randomly assigned to the treatment or control group. The treatment group used a CAI tutorial for completing homework assignments and the control group used the required textbook for completing homework assignments. The Attitude toward Science and Computers Questionnaire and Achievement Test were the two instruments administered during this study to measure students' attitudes and achievement score changes. A multivariate analysis of covariance (MANCOVA), using hierarchical multiple regression/correlation (MRC), was employed to determine: (1) treatment versus control group attitude and achievement differences; and (2) male versus female attitude and achievement differences. The differences between the treatment group's and control group's homework averages were determined by t test analyses. The overall MANCOVA model was found to be significant at p < .05. Examining research factor set independent variables separately resulted in gender being the only variable that significantly contributed in explaining the variability in a dependent variable, attitudes toward science and computers. T test analyses of the homework averages showed no significant differences. Contradictory to the findings of this study, anecdotal information from personal communication, course evaluations, and homework assignments indicated favorable attitudes and higher achievement scores for a majority of the students in the treatment group.

Incentive and Reminder Strategies to Improve Response Rate for Internet-Based Physician Surveys: A Randomized Experiment

PubMed Central

Wittich, Christopher M; Daniels, Wendlyn L; West, Colin P; Harris, Ann M; Beebe, Timothy J

2016-01-01

Background Most research on how to enhance response rates in physician surveys has been done using paper surveys. Uncertainties remain regarding how to enhance response rates in Internet-based surveys. Objective To evaluate the impact of a low-cost nonmonetary incentive and paper mail reminders (formal letter and postcard) on response rates in Internet-based physician surveys. Methods We executed a factorial-design randomized experiment while conducting a nationally representative Internet-based physician survey. We invited 3966 physicians (randomly selected from a commercial database of all licensed US physicians) via email to complete an Internet-based survey. We used 2 randomly assigned email messages: one message offered a book upon survey completion, whereas the other did not mention the book but was otherwise identical. All nonrespondents received several email reminders. Some physicians were further assigned at random to receive 1 reminder via paper mail (either a postcard or a letter) or no paper reminder. The primary outcome of this study was the survey response rate. Results Of the 3966 physicians who were invited, 451 (11.4%) responded to at least one survey question and 336 (8.5%) completed the entire survey. Of those who were offered a book, 345/2973 (11.6%) responded compared with 106/993 (10.7%) who were not offered a book (odds ratio 1.10, 95% CI 0.87-1.38, P=.42). Regarding the paper mail reminder, 168/1572 (10.7%) letter recipients, 148/1561 (9.5%) postcard recipients, and 69/767 (9.0%) email-only recipients responded (P=.35). The response rate for those receiving letters or postcards was similar (odds ratio 1.14, 95% CI 0.91-1.44, P=.26). Conclusions Offering a modest nonmonetary incentive and sending a paper reminder did not improve survey response rate. Further research on how to enhance response rates in Internet-based physician surveys is needed. PMID:27637296

Incentive and Reminder Strategies to Improve Response Rate for Internet-Based Physician Surveys: A Randomized Experiment.

PubMed

Cook, David A; Wittich, Christopher M; Daniels, Wendlyn L; West, Colin P; Harris, Ann M; Beebe, Timothy J

2016-09-16

Most research on how to enhance response rates in physician surveys has been done using paper surveys. Uncertainties remain regarding how to enhance response rates in Internet-based surveys. To evaluate the impact of a low-cost nonmonetary incentive and paper mail reminders (formal letter and postcard) on response rates in Internet-based physician surveys. We executed a factorial-design randomized experiment while conducting a nationally representative Internet-based physician survey. We invited 3966 physicians (randomly selected from a commercial database of all licensed US physicians) via email to complete an Internet-based survey. We used 2 randomly assigned email messages: one message offered a book upon survey completion, whereas the other did not mention the book but was otherwise identical. All nonrespondents received several email reminders. Some physicians were further assigned at random to receive 1 reminder via paper mail (either a postcard or a letter) or no paper reminder. The primary outcome of this study was the survey response rate. Of the 3966 physicians who were invited, 451 (11.4%) responded to at least one survey question and 336 (8.5%) completed the entire survey. Of those who were offered a book, 345/2973 (11.6%) responded compared with 106/993 (10.7%) who were not offered a book (odds ratio 1.10, 95% CI 0.87-1.38, P=.42). Regarding the paper mail reminder, 168/1572 (10.7%) letter recipients, 148/1561 (9.5%) postcard recipients, and 69/767 (9.0%) email-only recipients responded (P=.35). The response rate for those receiving letters or postcards was similar (odds ratio 1.14, 95% CI 0.91-1.44, P=.26). Offering a modest nonmonetary incentive and sending a paper reminder did not improve survey response rate. Further research on how to enhance response rates in Internet-based physician surveys is needed.

Research Methods in Healthcare Epidemiology and Antimicrobial Stewardship – Quasi-Experimental Designs

PubMed Central

Schweizer, Marin L.; Braun, Barbara I.; Milstone, Aaron M.

2016-01-01

Quasi-experimental studies evaluate the association between an intervention and an outcome using experiments in which the intervention is not randomly assigned. Quasi-experimental studies are often used to evaluate rapid responses to outbreaks or other patient safety problems requiring prompt non-randomized interventions. Quasi-experimental studies can be categorized into three major types: interrupted time series designs, designs with control groups, and designs without control groups. This methods paper highlights key considerations for quasi-experimental studies in healthcare epidemiology and antimicrobial stewardship including study design and analytic approaches to avoid selection bias and other common pitfalls of quasi-experimental studies. PMID:27267457

Does Professor Quality Matter? Evidence from Random Assignment of Students to Professors. NBER Working Paper No. 14081

ERIC Educational Resources Information Center

Carrell, Scott E.; West, James E.

2008-01-01

It is difficult to measure teaching quality at the postsecondary level because students typically "self-select" their coursework and their professors. Despite this, student evaluations of professors are widely used in faculty promotion and tenure decisions. We exploit the random assignment of college students to professors in a large body of…

The Effects of Therapist Competence in Assigning Homework in Cognitive Therapy with Cluster C Personality Disorders: Results from a Randomized Controlled Trial

ERIC Educational Resources Information Center

Ryum, Truls; Stiles, Tore C.; Svartberg, Martin; McCullough, Leigh

2010-01-01

Therapist competence in assigning homework was used to predict mid- and posttreatment outcome for patients with Cluster C personality disorders in cognitive therapy (CT). Twenty-five patients that underwent 40 sessions of CT were taken from a randomized controlled trial (Svartberg, Stiles, & Seltzer, 2004). Therapist competence in assigning…

The Efficacy of Fast ForWord Language Intervention in School-Age Children with Language Impairment: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Gillam, Ronald B.; Loeb, Diane Frome; Hoffman, LaVae M.; Bohman, Thomas; Champlin, Craig A.; Thibodeau, Linda; Widen, Judith; Brandel, Jayne; Friel-Patti, Sandy

2008-01-01

Purpose: A randomized controlled trial was conducted to compare the language and auditory processing outcomes of children assigned to receive the Fast ForWord Language intervention (FFW-L) with the outcomes of children assigned to nonspecific or specific language intervention comparison treatments that did not contain modified speech. Method: Two…

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

ERIC Educational Resources Information Center

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

2017-01-01

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

Random Assignment of Schools to Groups in the Drug Resistance Strategies Rural Project: Some New Methodological Twists

PubMed Central

Pettigrew, Jonathan; Miller-Day, Michelle; Krieger, Janice L.; Zhou, Jiangxiu; Hecht, Michael L.

2014-01-01

Random assignment to groups is the foundation for scientifically rigorous clinical trials. But assignment is challenging in group randomized trials when only a few units (schools) are assigned to each condition. In the DRSR project, we assigned 39 rural Pennsylvania and Ohio schools to three conditions (rural, classic, control). But even with 13 schools per condition, achieving pretest equivalence on important variables is not guaranteed. We collected data on six important school-level variables: rurality, number of grades in the school, enrollment per grade, percent white, percent receiving free/assisted lunch, and test scores. Key to our procedure was the inclusion of school-level drug use data, available for a subset of the schools. Also, key was that we handled the partial data with modern missing data techniques. We chose to create one composite stratifying variable based on the seven school-level variables available. Principal components analysis with the seven variables yielded two factors, which were averaged to form the composite inflate-suppress (CIS) score which was the basis of stratification. The CIS score was broken into three strata within each state; schools were assigned at random to the three program conditions from within each stratum, within each state. Results showed that program group membership was unrelated to the CIS score, the two factors making up the CIS score, and the seven items making up the factors. Program group membership was not significantly related to pretest measures of drug use (alcohol, cigarettes, marijuana, chewing tobacco; smallest p>.15), thus verifying that pretest equivalence was achieved. PMID:23722619

A randomized trial of nicotine-replacement therapy patches in pregnancy.

PubMed

Coleman, Tim; Cooper, Sue; Thornton, James G; Grainge, Matthew J; Watts, Kim; Britton, John; Lewis, Sarah

2012-03-01

Nicotine-replacement therapy is effective for smoking cessation outside pregnancy and its use is widely recommended during pregnancy. We investigated the efficacy and safety of nicotine patches during pregnancy. We recruited participants from seven hospitals in England who were 16 to 50 years of age with pregnancies of 12 to 24 weeks' gestation and who smoked five or more cigarettes per day. Participants received behavioral cessation support and were randomly assigned to 8 weeks of treatment with active nicotine patches (15 mg per 16 hours) or matched placebo patches. The primary outcome was abstinence from the date of smoking cessation until delivery, as validated by measurement of exhaled carbon monoxide or salivary cotinine. Safety was assessed by monitoring for adverse pregnancy and birth outcomes. Of 1050 participants, 521 were randomly assigned to nicotine-replacement therapy and 529 to placebo. There was no significant difference in the rate of abstinence from the quit date until delivery between the nicotine-replacement and placebo groups (9.4% and 7.6%, respectively; unadjusted odds ratio with nicotine-replacement therapy, 1.26; 95% confidence interval, 0.82 to 1.96), although the rate was higher at 1 month in the nicotine-replacement group than in the placebo group (21.3% vs. 11.7%). Compliance was low; only 7.2% of women assigned to nicotine-replacement therapy and 2.8% assigned to placebo used patches for more than 1 month. Rates of adverse pregnancy and birth outcomes were similar in the two groups. Adding a nicotine patch (15 mg per 16 hours) to behavioral cessation support for women who smoked during pregnancy did not significantly increase the rate of abstinence from smoking until delivery or the risk of adverse pregnancy or birth outcomes. However, low compliance rates substantially limited the assessment of safety. (Funded by the National Institute for Health Research Health Technology Assessment Programme; Current Controlled Trials number, ISRCTN07249128.).

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

NASA Astrophysics Data System (ADS)

Chaibub Neto, Elias

2016-11-01

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

Medicare Part D Roulette: Potential Implications of Random Assignment and Plan Restrictions

PubMed Central

Patel, Rajul A.; Walberg, Mark P.; Woelfel, Joseph A.; Amaral, Michelle M.; Varu, Paresh

2013-01-01

Background Dual-eligible (Medicare/Medicaid) beneficiaries are randomly assigned to a benchmark plan, which provides prescription drug coverage under the Part D benefit without consideration of their prescription drug profile. To date, the potential for beneficiary assignment to a plan with poor formulary coverage has been minimally studied and the resultant financial impact to beneficiaries unknown. Objective We sought to determine cost variability and drug use restrictions under each available 2010 California benchmark plan. Methods Dual-eligible beneficiaries were provided Part D plan assistance during the 2010 annual election period. The Medicare Web site was used to determine benchmark plan costs and prescription utilization restrictions for each of the six California benchmark plans available for random assignment in 2010. A standardized survey was used to record all de-identified beneficiary demographic and plan specific data. For each low-income subsidy-recipient (n = 113), cost, rank, number of non-formulary medications, and prescription utilization restrictions were recorded for each available 2010 California benchmark plan. Formulary matching rates (percent of beneficiary's medications on plan formulary) were calculated for each benchmark plan. Results Auto-assigned beneficiaries had only a 34% chance of being assigned to the lowest cost plan; the remainder faced potentially significant avoidable out-of-pocket costs. Wide variations between benchmark plans were observed for plan cost, formulary coverage, formulary matching rates, and prescription utilization restrictions. Conclusions Beneficiaries had a 66% chance of being assigned to a sub-optimal plan; thereby, they faced significant avoidable out-of-pocket costs. Alternative methods of beneficiary assignment could decrease beneficiary and Medicare costs while also reducing medication non-compliance. PMID:24753963

Transcendental Meditation and Reduced Trauma Symptoms in Female Inmates: A Randomized Controlled Study

PubMed Central

Nidich, Sanford; Seng, Angela; Compton, Blaze; O’Connor, Tom; Salerno, John W; Nidich, Randi

2017-01-01

Context: Compared with the general population, trauma experiences are higher among incarcerated women. Objective: To evaluate the effects of Transcendental Meditation (TM) on trauma symptoms in female offenders. Design: Twenty-two inmates at the Coffee Creek Correctional Facility in Wilsonville, OR, with at least 4 months left of incarceration were enrolled in this randomized controlled pilot study. Subjects were randomly assigned to either the TM group (n = 11) or a wait-list control group (n = 11). Main Outcome Measures: Subjects were measured at baseline and 4-month posttest using the Posttraumatic Stress Disorder Checklist-Civilian version (PCL-C; primary outcome) with intrusive thoughts, avoidance, and hyperarousal subscales (secondary outcomes). Twenty of the subjects (10 in each group) took part in their treatment assignment and completed posttesting. Results: Significant reductions were found on total trauma (p < 0.036), intrusive thoughts (p < 0.026), and hyperarousal (p < 0.043) on the PCL-C. Effect sizes ranged from 0.65 to 0.99 for all variables. Eighty-one percent of the TM subjects were compliant with their program. Conclusion: The results of this study indicate feasibility of the TM program in a female prison population and suggest that TM may be an effective tool for decreasing trauma symptoms. Future large-scale research is warranted. PMID:28333611

Small Cash Incentives Can Encourage Primary Care Visits By Low-Income People With New Health Care Coverage.

PubMed

Bradley, Cathy J; Neumark, David

2017-08-01

In a randomized controlled trial, we studied low-income adults newly covered by a primary care program to determine whether a cash incentive could encourage them to make an initial visit to a primary care provider. Subjects were randomly assigned to one of four groups: three groups whose members received $10 to complete a baseline survey during an interview and who were randomized to incentives of $50, $25, or $0 to visit their assigned primary care provider within six months after enrolling in the study; and a nonincentivized control group not contacted by the research team. Subjects in the $50 and $25 incentive groups were more likely to see a primary care provider (77 percent and 74 percent, respectively), compared to subjects in the $0 incentive group (68 percent). The effects of the intervention were about twice as large when we compared the proportions of subjects in the $50 and $25 incentive groups who visited their providers and the proportion in the nonincentivized group (61 percent). Cash incentive programs may steer newly covered low-income patients toward primary care, which could result in improved health outcomes and lower costs. Project HOPE—The People-to-People Health Foundation, Inc.

A Randomized Controlled Trial of Two Syntactic Treatment Procedures With Cantonese-Speaking, School-Age Children With Language Disorders.

PubMed

To, Carol K S; Lui, Hoi Ming; Li, Xin Xin; Lam, Gary Y H

2015-08-01

In this study, we aimed to evaluate the efficacy of sentence-combining (SC) and narrative-based (NAR) intervention approaches to syntax intervention using a randomized-controlled-trial design. Fifty-two Cantonese-speaking, school-age children with language impairment were assigned randomly to either the SC or the NAR treatment arm. Seven children did not receive treatment as assigned. Intervention in both arms targeted the same complex syntactical structures. The SC group focused on sentence combination training, whereas the NAR group made use of narratives in which the target structures were embedded. Pretest and posttest performances measured using a standardized language assessment were subjected to analyses of covariance mixed-effect-model analyses of variance. Children in both treatment arms demonstrated significant growth after 4 months of intervention. The main effect between treatment arms and time was not significant after controlling the pretest performance, suggesting that both treatment approaches showed similar effects. The main effect of time was significant. This study provided evidence to support language intervention in the school years in Cantonese-speaking children. However, neither approach was shown to be more efficacious than the other. Future researchers could examine the effects of a longer treatment period and include functional outcome measures.

Transcendental Meditation and Reduced Trauma Symptoms in Female Inmates: A Randomized Controlled Study.

PubMed

Nidich, Sanford; Seng, Angela; Compton, Blaze; O'connor, Tom; Salerno, John W; Nidich, Randi

2017-01-01

Compared with the general population, trauma experiences are higher among incarcerated women. To evaluate the effects of Transcendental Meditation (TM) on trauma symptoms in female offenders. Twenty-two inmates at the Coffee Creek Correctional Facility in Wilsonville, OR, with at least 4 months left of incarceration were enrolled in this randomized controlled pilot study. Subjects were randomly assigned to either the TM group (n = 11) or a wait-list control group (n = 11). Subjects were measured at baseline and 4-month posttest using the Posttraumatic Stress Disorder Checklist-Civilian version (PCL-C; primary outcome) with intrusive thoughts, avoidance, and hyperarousal subscales (secondary outcomes). Twenty of the subjects (10 in each group) took part in their treatment assignment and completed posttesting. Significant reductions were found on total trauma (p < 0.036), intrusive thoughts (p < 0.026), and hyperarousal (p < 0.043) on the PCL-C. Effect sizes ranged from 0.65 to 0.99 for all variables. Eighty-one percent of the TM subjects were compliant with their program. The results of this study indicate feasibility of the TM program in a female prison population and suggest that TM may be an effective tool for decreasing trauma symptoms. Future large-scale research is warranted.

HyDEn: A Hybrid Steganocryptographic Approach for Data Encryption Using Randomized Error-Correcting DNA Codes

PubMed Central

Regoui, Chaouki; Durand, Guillaume; Belliveau, Luc; Léger, Serge

2013-01-01

This paper presents a novel hybrid DNA encryption (HyDEn) approach that uses randomized assignments of unique error-correcting DNA Hamming code words for single characters in the extended ASCII set. HyDEn relies on custom-built quaternary codes and a private key used in the randomized assignment of code words and the cyclic permutations applied on the encoded message. Along with its ability to detect and correct errors, HyDEn equals or outperforms existing cryptographic methods and represents a promising in silico DNA steganographic approach. PMID:23984392

The (Surprising) Impact of Televised Antidepressant Direct-to-Consumer Advertising on the Stigmatization of Mental Illness.

PubMed

Rainone, Nicolette; Oodal, Reshma; Niederdeppe, Jeff

2018-04-01

This study tests the effect of pharmaceutical Direct-to-Consumer Advertising (DTCA) for antidepressants on perceived stigma surrounding mental disorders. We randomly assigned participants into one of three experimental conditions: antidepressant DTCA with portrayals of discrimination, cognitive separation, and stereotyping (DCSS), antidepressant DTCA without these representations, or a no-exposure control. Contrary to study hypotheses, participants who viewed ads containing portrayals of DCSS were significantly less likely to want to socially distance themselves from those with mental illnesses than those assigned to the no-exposure control condition, even when controlling for demographics and personal experience with mental illness. We discuss plausible explanations for the unexpected pattern of effects and resulting implications for future research on the topic.

Immediate and Short-Term Effects of the 5th Grade Version of the "keepin' it REAL" Substance Use Prevention Intervention

ERIC Educational Resources Information Center

Hecht, Michael L.; Elek, Elvira; Wagstaff, David A.; Kam, Jennifer A.; Marsiglia, Flavio; Dustman, Patricia; Reeves, Leslie; Harthun, Mary

2009-01-01

This study assessed the immediate and short-term outcomes of adapting a culturally-grounded middle school program, "keepin' it REAL", for elementary school students. After curriculum adaptation, 10 schools were randomly assigned to the intervention in 5th grade with follow-up boosters in 6th grade; 13 schools were randomly assigned to the control…

Mentoring in Schools: An Impact Study of Big Brothers Big Sisters School-Based Mentoring

ERIC Educational Resources Information Center

Herrera, Carla; Grossman, Jean Baldwin; Kauh, Tina J.; McMaken, Jennifer

2011-01-01

This random assignment impact study of Big Brothers Big Sisters School-Based Mentoring involved 1,139 9- to 16-year-old students in 10 cities nationwide. Youth were randomly assigned to either a treatment group (receiving mentoring) or a control group (receiving no mentoring) and were followed for 1.5 school years. At the end of the first school…

Student Sorting and Bias in Value Added Estimation: Selection on Observables and Unobservables. NBER Working Paper No. 14666

ERIC Educational Resources Information Center

Rothstein, Jesse

2009-01-01

Non-random assignment of students to teachers can bias value added estimates of teachers' causal effects. Rothstein (2008a, b) shows that typical value added models indicate large counter-factual effects of 5th grade teachers on students' 4th grade learning, indicating that classroom assignments are far from random. This paper quantifies the…

Randomized Controlled Evaluation of the "Too Good for Drugs" Prevention Program: Impact on Adolescents at Different Risk Levels for Drug Use

ERIC Educational Resources Information Center

Hall, Bruce W.; Bacon, Tina P.; Ferron, John M.

2013-01-01

Sixth graders participating in the "Too Good for Drugs" (TGFD) prevention program in comparison to 6th graders not participating show different results by student risk level. Sixth graders from 20 middle schools were randomly assigned to receive the intervention and those from 20 paired middle schools assigned to serve as controls (N =…

Social and Clinical Effects of a Leisure Program on Adults with Autism Spectrum Disorder

ERIC Educational Resources Information Center

Garcia-Villamisar, Domingo; Dattilo, John

2011-01-01

Using a pre-test, post-test experimental design, effects of a 1-year group leisure program were examined on 31 participants (20 male and 11 female), ages 27-38 (M = 32.05 at start of program), with an autism spectrum disorder (ASD) diagnosis randomly assigned to the experimental condition and a group of 20 adults with ASD randomly assigned to the…

Just-in-time consent: The ethical case for an alternative to traditional informed consent in randomized trials comparing an experimental intervention with usual care.

PubMed

Vickers, Andrew J; Young-Afat, Danny A; Ehdaie, Behfar; Kim, Scott Yh

2018-02-01

Informed consent for randomized trials often causes significant and persistent anxiety, distress and confusion to patients. Where an experimental treatment is compared to a standard care control, much of this burden is potentially avoidable in the control group. We propose a "just-in-time" consent in which consent discussions take place in two stages: an initial consent to research from all participants and a later specific consent to randomized treatment only from those assigned to the experimental intervention. All patients are first approached and informed about research procedures, such as questionnaires or tests. They are also informed that they might be randomly selected to receive an experimental treatment and that, if selected, they can learn more about the treatment and decide whether or not to accept it at that time. After randomization, control patients undergo standard clinical consent whereas patients randomized to the experimental procedure undergo a second consent discussion. Analysis would be by intent-to-treat, which protects the trial from selection bias, although not from poor acceptance of experimental treatment. The advantages of just-in-time consent stem from the fact that only patients randomized to the experimental treatment are subject to a discussion of that intervention. We hypothesize that this will reduce much of the patient's burden associated with the consent process, such as decisional anxiety, confusion and information overload. We recommend well-controlled studies to compare just-in-time and traditional consent, with endpoints to include characteristics of participants, distress and anxiety and participants' understanding of research procedures.

A Model for Pharmacological Research-Treatment of Cocaine Dependence

PubMed Central

Montoya, Ivan D.; Hess, Judith M.; Preston, Kenzie L.; Gorelick, David A.

2008-01-01

Major problems for research on pharmacological treatments for cocaine dependence are lack of comparability of results from different treatment research programs and poor validity and/or reliability of results. Double-blind, placebo-controlled, random assignment, experimental designs, using standard intake and assessment procedures help to reduce these problems. Cessation or reduction of drug use and/or craving, retention in treatment, and medical and psychosocial improvement are some of the outcome variables collected in treatment research programs. A model to be followed across different outpatient clinical trials for pharmacological treatment of cocaine dependence is presented here. This model represents an effort to standardize data collection to make results more valid and comparable. PMID:8749725

Relapse prevention interventions for smoking cessation.

PubMed

Hajek, Peter; Stead, Lindsay F; West, Robert; Jarvis, Martin; Hartmann-Boyce, Jamie; Lancaster, Tim

2013-08-20

A number of treatments can help smokers make a successful quit attempt, but many initially successful quitters relapse over time. Several interventions have been proposed to help prevent relapse. To assess whether specific interventions for relapse prevention reduce the proportion of recent quitters who return to smoking. We searched the Cochrane Tobacco Addiction Group trials register in May 2013 for studies mentioning relapse prevention or maintenance in title, abstracts or keywords. Randomized or quasi-randomized controlled trials of relapse prevention interventions with a minimum follow-up of six months. We included smokers who quit on their own, were undergoing enforced abstinence, or were participating in treatment programmes. We included trials that compared relapse prevention interventions with a no intervention control, or that compared a cessation programme with additional relapse prevention components with a cessation programme alone. Studies were screened and data extracted by one review author, and checked by a second. Disagreements were resolved by discussion or by referral to a third review author. Sixty-three studies met inclusion criteria but were heterogeneous in terms of populations and interventions. We considered 41 studies that randomly assigned abstainers separately from studies that randomly assigned participants before their quit date.Upon looking at studies of behavioural interventions that randomly assigned abstainers, we detected no benefit of brief and 'skills-based' relapse prevention methods for women who had quit smoking because of pregnancy, or for smokers undergoing a period of enforced abstinence during hospitalisation or military training. We also failed to detect significant effects of behavioural interventions in trials in unselected groups of smokers who had quit on their own or through a formal programme. Amongst trials randomly assigning smokers before their quit date and evaluating the effects of additional relapse prevention components, we found no evidence of benefit of behavioural interventions or combined behavioural and pharmacotherapeutic interventions in any subgroup. Overall, providing training in skills thought to be needed for relapse avoidance did not reduce relapse, but most studies did not use experimental designs best suited to the task and had limited power to detect expected small differences between interventions. For pharmacological interventions, extended treatment with varenicline significantly reduced relapse in one trial (risk ratio (RR) 1.18, 95% confidence interval (CI) 1.03 to 1.36). Pooling of six studies of extended treatment with bupropion failed to detect a significant effect (RR 1.15, 95% CI 0.98 to 1.35). Two small trials of oral nicotine replacement treatment (NRT) failed to detect an effect, but treatment compliance was low, and in two other trials of oral NRT in which short-term abstainers were randomly assigned, a significant effect of intervention was noted. At the moment, there is insufficient evidence to support the use of any specific behavioural intervention to help smokers who have successfully quit for a short time to avoid relapse. The verdict is strongest for interventions focused on identifying and resolving tempting situations, as most studies were concerned with these. Little research is available regarding other behavioural approaches.Extended treatment with varenicline may prevent relapse. Extended treatment with bupropion is unlikely to have a clinically important effect. Studies of extended treatment with nicotine replacement are needed.

Telling Stories and Making Books: Evidence for an Intervention to Help Parents in Migrant Head Start Families Support Their Children's Language and Literacy

ERIC Educational Resources Information Center

Boyce, Lisa K.; Innocenti, Mark S.; Roggman, Lori A.; Norman, Vonda K. Jump; Ortiz, Eduardo

2010-01-01

Research Findings: In this study, 75 Spanish-speaking preschoolers (M age = 41.43 months, SD = 10.78 months; 30 girls) attending a Migrant Head Start program were randomly assigned to receive the Storytelling for the Home Enrichment of Language and Literacy Skills (SHELLS) in addition to their Head Start services (n = 32) or to continue to receive…

Preparing Brigade Combat Team Soldiers for Mission Readiness Through Research on Intangible Psychological Constructs and Their Applications: Phase 1

DTIC Science & Technology

2014-02-01

were randomly assigned to treatment groups and examined using a pretest , posttest , and follow-up to evaluate the impact of patient interview and...results of the literature review to inform interview and focus group protocol development for follow on data collection. Literature Review The...similar content or overlapped considerably with one another. Accordingly, similar constructs were grouped under meta- construct headings. A total of

Non-invasive high-frequency ventilation versus bi-phasic continuous positive airway pressure (BP-CPAP) following CPAP failure in infants <1250 g: a pilot randomized controlled trial.

PubMed

Mukerji, A; Sarmiento, K; Lee, B; Hassall, K; Shah, V

2017-01-01

Non-invasive high-frequency ventilation (NIHFV), a relatively new modality, is gaining popularity despite limited data. We sought to evaluate the effectiveness of NIHFV versus bi-phasic continuous positive airway pressure (BP-CPAP) in preterm infants failing CPAP. Infants with BW<1250 g on CPAP were randomly assigned to NIHFV or BP-CPAP if they met pre-determined criteria for CPAP failure. Infants were eligible for randomization after 72 h age and until 2000 g. Guidelines for adjustment of settings and criteria for failure of assigned mode were implemented. The primary aim was to assess feasibility of a larger trial. In addition, failure of assigned non-invasive respiratory support (NRS) mode, invasive mechanical ventilation (MV) 72 h and 7 days post-randomization, and bronchopulmonary dysplasia (BPD) were assessed. Thirty-nine infants were randomized to NIHFV (N=16) or BP-CPAP (N=23). There were no significant differences in mean (s.d.) postmenstrual age (28.6 (1.5) versus 29.0 (2.3) weeks, P=0.47), mean (s.d.) weight at randomization (965.0 (227.0) versus 958.1 (310.4) g, P=0.94) or other baseline demographics between the groups. Failure of assigned NRS mode was lower with NIHFV (37.5 versus 65.2%, P=0.09), although not statistically significant. There were no differences in rates of invasive MV 72 h and 7 days post-randomization or BPD. NIHFV was not superior to BP-CPAP in this pilot study. Effectiveness of NIHFV needs to be proven in larger multi-center, appropriately powered trials before widespread implementation.

Bovine Reproductive Palpation Training: Does the Cow Make a Difference?

PubMed

French, Hilari M; Dascanio, John J; Gilbert, Gregory E; Robinson, James Q

2018-01-01

Gaining experience and dexterity for trans-rectal cattle palpation requires substantial training. Simulation allows students to perform palpation without risks and to obtain feedback, but many believe live cattle palpation is essential. Limited research exists on the proper training method for live animal trans-rectal palpation. This study compared student improvement in laboratory palpation skills when assigned to the same cows versus choosing a cow at random. The hypothesis for the study was that students assigned the same cow, as compared to students choosing a cow at random, would be more accurate at palpation, would learn what structures are present on the ovaries and what size the reproductive tract measures, and would be able to follow the cyclicity of the cow. Cervical diameter, uterine tone, diameter of left and right uterine horns, and ovarian structures were recorded over time. Responses were compared to laboratory instructors' responses and Z-tests for proportions were used to test the differences in percentage correct at each time point for each palpation exercise. Overall the experiment showed that assigning students to certain cows will not improve their trans-rectal palpation training. However, asking students to identify specific landmarks with quantitative measurements did allow for more productive laboratory time and engaged students. The results of the present study also suggest that if there is limited time available for palpation instruction, choosing cows with behavior allowing easy handling is important to the educational process.

Randomized Trial of Studer Pouch versus T-Pouch Orthotopic Ileal Neobladder in Patients with Bladder Cancer.

PubMed

Skinner, Eila C; Fairey, Adrian S; Groshen, Susan; Daneshmand, Siamak; Cai, Jie; Miranda, Gus; Skinner, Donald G

2015-08-01

The need to prevent reflux in the construction of an orthotopic ileal neobladder is controversial. We designed the USC-STAR trial to determine whether the T-pouch neobladder that included an antireflux mechanism was superior to the Studer pouch in patients with bladder cancer undergoing radical cystectomy. This single center, randomized, controlled trial recruited patients with clinically nonmetastatic bladder cancer scheduled to undergo radical cystectomy with neobladder. Eligible patients were randomly assigned to undergo T-pouch or Studer ileal orthotopic neobladder. Treatment assignment was not masked. The primary end point was change in renal function from baseline to 3 years. The CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation was used to calculate the estimated glomerular filtration rate. Between February 2002 and November 2009, 237 patients were randomly assigned to T-pouch ileal orthotopic neobladder and 247 to Studer ileal orthotopic neobladder. Baseline characteristics did not differ between the groups. Between baseline and 3 years the estimated glomerular filtration rate decreased by 6.4 ml/minute/1.73 m(2) in the Studer group and 6.6 ml/minute/1.73 m(2) in the T-pouch group (p=0.35). Multivariable analysis showed that type of ileal orthotopic neobladder was not independently associated with 3-year renal function (p=0.63). However, baseline estimated glomerular filtration rate, age and urinary tract obstruction were independently associated with 3-year decline in renal function. Cumulative risk of urinary tract infection and overall late complications were not different between the groups, but the T-pouch was associated with an increased risk of secondary diversion related surgeries. T-pouch ileal orthotopic neobladder with an antireflux mechanism did not prevent a moderate reduction in renal function observed at 3 years compared to the Studer pouch, but did result in an increase in diversion related secondary surgical procedures. Copyright © 2015 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Efficacy and cost of video-assisted thoracoscopic partial pleurectomy versus talc pleurodesis in patients with malignant pleural mesothelioma (MesoVATS): an open-label, randomised, controlled trial.

PubMed

Rintoul, Robert C; Ritchie, Andrew J; Edwards, John G; Waller, David A; Coonar, Aman S; Bennett, Maxine; Lovato, Eleonora; Hughes, Victoria; Fox-Rushby, Julia A; Sharples, Linda D

2014-09-20

Malignant pleural mesothelioma incidence continues to rise, with few available evidence-based therapeutic options. Results of previous non-randomised studies suggested that video-assisted thoracoscopic partial pleurectomy (VAT-PP) might improve symptom control and survival. We aimed to compare efficacy in terms of overall survival, and cost, of VAT-PP and talc pleurodesis in patients with malignant pleural mesothelioma. We undertook an open-label, parallel-group, randomised, controlled trial in patients aged 18 years or older with any subtype of confirmed or suspected mesothelioma with pleural effusion, recruited from 12 hospitals in the UK. Eligible patients were randomly assigned (1:1) to either VAT-PP or talc pleurodesis by computer-generated random numbers, stratified by European Organisation for Research and Treatment of Cancer risk category (high vs low). The primary outcome was overall survival at 1 year, analysed by intention to treat (all patients randomly assigned to a treatment group with a final diagnosis of mesothelioma). This trial is registered with ClinicalTrials.gov, number NCT00821860. Between Oct 24, 2003, and Jan 24, 2012, we randomly assigned 196 patients, of whom 175 (88 assigned to talc pleurodesis, 87 assigned to VAT-PP) had confirmed mesothelioma. Overall survival at 1 year was 52% (95% CI 41-62) in the VAT-PP group and 57% (46-66) in the talc pleurodesis group (hazard ratio 1·04 [95% CI 0·76-1·42]; p=0·81). Surgical complications were significantly more common after VAT-PP than after talc pleurodesis, occurring in 24 (31%) of 78 patients who completed VAT-PP versus ten (14%) of 73 patients who completed talc pleurodesis (p=0·019), as were respiratory complications (19 [24%] vs 11 [15%]; p=0·22) and air-leak beyond 10 days (five [6%] vs one [1%]; p=0·21), although not significantly so. Median hospital stay was longer at 7 days (IQR 5-11) in patients who received VAT-PP compared with 3 days (2-5) for those who received talc pleurodesis (p<0·0001). VAT-PP is not recommended to improve overall survival in patients with pleural effusion due to malignant pleural mesothelioma, and talc pleurodesis might be preferable considering the fewer complications and shorter hospital stay associated with this treatment. BUPA Foundation. Copyright © 2014 Elsevier Ltd. All rights reserved.

The Demand for, and Impact of, Learning HIV Status

PubMed Central

Thornton, Rebecca L.

2011-01-01

This paper evaluates an experiment in which individuals in rural Malawi were randomly assigned monetary incentives to learn their HIV results after being tested. Distance to the HIV results centers was also randomly assigned. Without any incentive, 34 percent of the participants learned their HIV results. However, even the smallest incentive doubled that share. Using the randomly assigned incentives and distance from results centers as instruments for the knowledge of HIV status, sexually active HIV-positive individuals who learned their results are three times more likely to purchase condoms two months later than sexually active HIV-positive individuals who did not learn their results; however, HIV-positive individuals who learned their results purchase only two additional condoms than those who did not. There is no significant effect of learning HIV-negative status on the purchase of condoms. PMID:21687831

47 CFR 1.948 - Assignment of authorization or transfer of control, notification of consummation.

Code of Federal Regulations, 2013 CFR

2013-10-01

... COMMISSION GENERAL PRACTICE AND PROCEDURE Grants by Random Selection Wireless Radio Services Applications and... involuntary assignment or transfer. (d) Notification of consummation. In all Wireless Radio Services... radio station in the Wireless Radio Services is assigned to another party, voluntarily or involuntarily...

47 CFR 1.948 - Assignment of authorization or transfer of control, notification of consummation.

Code of Federal Regulations, 2014 CFR

2014-10-01

... COMMISSION GENERAL PRACTICE AND PROCEDURE Grants by Random Selection Wireless Radio Services Applications and... involuntary assignment or transfer. (d) Notification of consummation. In all Wireless Radio Services... radio station in the Wireless Radio Services is assigned to another party, voluntarily or involuntarily...

47 CFR 1.948 - Assignment of authorization or transfer of control, notification of consummation.

Code of Federal Regulations, 2012 CFR

2012-10-01

... COMMISSION GENERAL PRACTICE AND PROCEDURE Grants by Random Selection Wireless Radio Services Applications and... involuntary assignment or transfer. (d) Notification of consummation. In all Wireless Radio Services... radio station in the Wireless Radio Services is assigned to another party, voluntarily or involuntarily...

47 CFR 1.9055 - Assignment of file numbers to spectrum leasing notifications and applications.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 47 Telecommunication 1 2012-10-01 2012-10-01 false Assignment of file numbers to spectrum leasing... GENERAL PRACTICE AND PROCEDURE Grants by Random Selection Spectrum Leasing General Policies and Procedures § 1.9055 Assignment of file numbers to spectrum leasing notifications and applications. Spectrum...

47 CFR 1.9055 - Assignment of file numbers to spectrum leasing notifications and applications.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 47 Telecommunication 1 2013-10-01 2013-10-01 false Assignment of file numbers to spectrum leasing... GENERAL PRACTICE AND PROCEDURE Grants by Random Selection Spectrum Leasing General Policies and Procedures § 1.9055 Assignment of file numbers to spectrum leasing notifications and applications. Spectrum...

47 CFR 1.9055 - Assignment of file numbers to spectrum leasing notifications and applications.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 47 Telecommunication 1 2014-10-01 2014-10-01 false Assignment of file numbers to spectrum leasing... GENERAL PRACTICE AND PROCEDURE Grants by Random Selection Spectrum Leasing General Policies and Procedures § 1.9055 Assignment of file numbers to spectrum leasing notifications and applications. Spectrum...

Randomizing Roaches: Exploring the "Bugs" of Randomization in Experimental Design

ERIC Educational Resources Information Center

Wagler, Amy; Wagler, Ron

2014-01-01

Understanding the roles of random selection and random assignment in experimental design is a central learning objective in most introductory statistics courses. This article describes an activity, appropriate for a high school or introductory statistics course, designed to teach the concepts, values and pitfalls of random selection and assignment…

Effects of a Brief Multimedia Psychoeducational Intervention on the Attitudes and Interest of Patients With Cancer Regarding Clinical Trial Participation: A Multicenter Randomized Controlled Trial

PubMed Central

Jacobsen, Paul B.; Wells, Kristen J.; Meade, Cathy D.; Quinn, Gwendolyn P.; Lee, Ji-Hyun; Fulp, William J.; Gray, Jhanelle E.; Baz, Rachid C.; Springett, Gregory M.; Levine, Richard M.; Markham, Merry-Jennifer; Schreiber, Fred J.; Cartwright, Thomas H.; Burke, James M.; Siegel, Robert D.; Malafa, Mokenge P.; Sullivan, Daniel

2012-01-01

Purpose The negative attitudes of patients with cancer regarding clinical trials are an important contributor to low participation rates. This study evaluated whether a brief psychoeducational intervention was effective in improving patients' attitudes as well as their knowledge, self-efficacy for decision making, receptivity to receiving more information, and general willingness to participate in clinical trials. Patients and Methods A total of 472 adults with cancer who had not been asked previously to participate in a clinical trial were randomly assigned to receive printed educational information about clinical trials or a psychoeducational intervention that provided similar information and also addressed misperceptions and concerns about clinical trials. The primary (attitudes) and secondary outcomes (knowledge, self-efficacy, receptivity, and willingness) were assessed via patient self-report before random assignment and 7 to 28 days later. Results Patients who received the psychoeducational intervention showed more positive attitudes toward clinical trials (P = .016) and greater willingness to participate (P = .011) at follow-up than patients who received printed educational information. Evidence of an indirect effect of intervention assignment on willingness to participate (estimated at 0.168; 95% CI, 0.088 to 0.248) suggested that the benefits of psychoeducation on willingness to participate were explained by the positive impact of psychoeducation on attitudes toward clinical trials. Conclusion A brief psychoeducational intervention can improve the attitudes of patients with cancer toward clinical trials and thereby increase their willingness to participate in clinical trials. Findings support conducting additional research to evaluate effects of this intervention on quality of decision making and rates of participation among patients asked to enroll onto therapeutic clinical trials. PMID:22614993

Stopping vs. Continuing Aspirin before Coronary Artery Surgery.

PubMed

Myles, Paul S; Smith, Julian A; Forbes, Andrew; Silbert, Brendan; Jayarajah, Mohandas; Painter, Thomas; Cooper, D James; Marasco, Silvana; McNeil, John; Bussières, Jean S; Wallace, Sophie

2016-02-25

Most patients with coronary artery disease receive aspirin for primary or secondary prevention of myocardial infarction, stroke, and death. Aspirin poses a risk of bleeding in patients undergoing surgery, but it is unclear whether aspirin should be stopped before coronary artery surgery. We used a 2-by-2 factorial trial design to randomly assign patients who were scheduled to undergo coronary artery surgery and were at risk for perioperative complications to receive aspirin or placebo and tranexamic acid or placebo. The results of the aspirin trial are reported here. Patients were randomly assigned to receive 100 mg of aspirin or matched placebo preoperatively. The primary outcome was a composite of death and thrombotic complications (nonfatal myocardial infarction, stroke, pulmonary embolism, renal failure, or bowel infarction) within 30 days after surgery. Among 5784 eligible patients, 2100 were enrolled; 1047 were randomly assigned to receive aspirin and 1053 to receive placebo. A primary outcome event occurred in 202 patients in the aspirin group (19.3%) and in 215 patients in the placebo group (20.4%) (relative risk, 0.94; 95% confidence interval, 0.80 to 1.12; P=0.55). Major hemorrhage leading to reoperation occurred in 1.8% of patients in the aspirin group and in 2.1% of patients in the placebo group (P=0.75), and cardiac tamponade occurred at rates of 1.1% and 0.4%, respectively (P=0.08). Among patients undergoing coronary artery surgery, the administration of preoperative aspirin resulted in neither a lower risk of death or thrombotic complications nor a higher risk of bleeding than that with placebo. (Funded by the Australian National Health and Medical Research Council and others; Australia New Zealand Clinical Trials Registry number, ACTRN12605000557639.).

Comparative Effectiveness of Sphincter-Sparing Surgery versus Abdominoperineal Resection in Rectal Cancer: Patient-Reported Outcomes in National Surgical Adjuvant Breast and Bowel Project Randomized Trial R-04

PubMed Central

Russell, Marcia M.; Ganz, Patricia A.; Lopa, Samia; Yothers, Greg; Ko, Clifford Y.; Arora, Amit; Atkins, James N.; Bahary, Nathan; Soori, Gamini; Robertson, John M.; Eakle, Janice; Marchello, Benjamin T.; Wozniak, Timothy F.; Beart, Robert W.; Wolmark, Norman

2015-01-01

Objective NSABP R-04 was a randomized controlled trial of neoadjuvant chemoradiotherapy in patients with resectable stage II–III rectal cancer. We hypothesized that patients who underwent abdominoperineal resection (APR) would have a poorer quality of life than those who underwent sphincter-sparing surgery (SSS). Methods To obtain patient-reported outcomes (PROs) we administered two symptom scales at baseline and 1 year postoperatively: the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) and the European Organization for the Research and Treatment of Cancer module for patients with Colorectal Cancer Quality of Life Questionnaire (EORTC QLQ-CR38). Scoring was stratified by non-randomly assigned definitive surgery (APR vs SSS). Analyses controlled for baseline scores and stratification factors: age, gender, stage, intended surgery, and randomly assigned chemoradiotherapy. Results Of 1,608 randomly assigned patients, 987 had data for planned analyses; 62% underwent SSS; 38% underwent APR. FACT-C total and subscale scores were not statistically different by surgery at one year. For the EORTC-QLQ-CR38 functional scales, APR patients reported worse body image (70.3 vs 77.0, P=0.0005) at one year than did SSS patients. Males undergoing APR reported worse sexual enjoyment (43.7 vs 54.7, P=0.02) at one year than did those undergoing SSS. For the EORTC-QLQ-CR38 symptom scale scores, APR patients reported worse micturition symptoms than the SSS group at one year (26.9 vs 21.5, P=0.03). SSS patients reported worse GI tract symptoms than did the APR patients (18.9 vs 15.2, P<0.0001), as well as weight loss (10.1 vs 6.0, P=0.002). Conclusions Symptoms and functional problems were detected at one year by EORTC-QLQ-CR38, reflecting different symptom profiles in patients who underwent APR than those who underwent SSS. Information from these PROs may be useful in counseling patients anticipating surgery for rectal cancer. PMID:24670844

Specifying a target trial prevents immortal time bias and other self-inflicted injuries in observational analyses.

PubMed

Hernán, Miguel A; Sauer, Brian C; Hernández-Díaz, Sonia; Platt, Robert; Shrier, Ian

2016-11-01

Many analyses of observational data are attempts to emulate a target trial. The emulation of the target trial may fail when researchers deviate from simple principles that guide the design and analysis of randomized experiments. We review a framework to describe and prevent biases, including immortal time bias, that result from a failure to align start of follow-up, specification of eligibility, and treatment assignment. We review some analytic approaches to avoid these problems in comparative effectiveness or safety research. Copyright © 2016 Elsevier Inc. All rights reserved.

Motivating Treatment Seeking and Behavior Change by Untreated Military Personnel Abusing Alcohol or Drugs

DTIC Science & Technology

2016-12-01

participants were randomly assigned to  one  of two  study   conditions, each consisting of  one  45‐60 minute session by phone: (1) the  experimental  MET...the Perception of Drinking Norms among College Students . Journal of Studies on Alcohol, 52(6), 580-586. Blanchard, E. B., Jones-Alexander, J...applied research and evaluation. Dr. Mbilinyi has taught research courses for Masters of Social Work students . She has published on children’s exposure Su

Inspection of care: Findings from an innovative demonstration

PubMed Central

Morris, John N.; Sherwood, Clarence C.; Dreyer, Paul

1989-01-01

In this article, information is presented concerning the efficacy of a sample-based approach to completing inspection of care reviews of Medicaid-supported nursing home residents. Massachusetts nursing homes were randomly assigned to full (the control group) or sample (the experimental group) review conditions. The primary research focus was to determine whether the proportion of facilities found to be deficient (based on quality of care and level of care criteria) in the experimental sample was comparable to the proportion in the control sample. The findings supported such a hypothesis: Deficient facilities appear to be equally identifiable using the random or full-sampling protocols, and the process can be completed with a considerable savings of surveyor time. PMID:10313458

ARTS: automated randomization of multiple traits for study design.

PubMed

Maienschein-Cline, Mark; Lei, Zhengdeng; Gardeux, Vincent; Abbasi, Taimur; Machado, Roberto F; Gordeuk, Victor; Desai, Ankit A; Saraf, Santosh; Bahroos, Neil; Lussier, Yves

2014-06-01

Collecting data from large studies on high-throughput platforms, such as microarray or next-generation sequencing, typically requires processing samples in batches. There are often systematic but unpredictable biases from batch-to-batch, so proper randomization of biologically relevant traits across batches is crucial for distinguishing true biological differences from experimental artifacts. When a large number of traits are biologically relevant, as is common for clinical studies of patients with varying sex, age, genotype and medical background, proper randomization can be extremely difficult to prepare by hand, especially because traits may affect biological inferences, such as differential expression, in a combinatorial manner. Here we present ARTS (automated randomization of multiple traits for study design), which aids researchers in study design by automatically optimizing batch assignment for any number of samples, any number of traits and any batch size. ARTS is implemented in Perl and is available at github.com/mmaiensc/ARTS. ARTS is also available in the Galaxy Tool Shed, and can be used at the Galaxy installation hosted by the UIC Center for Research Informatics (CRI) at galaxy.cri.uic.edu. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Perceptions of adolescent bullying: attributions of blame and responsibility in cases of cyber-bullying.

PubMed

Morrow, Allison; Downey, Christina A

2013-12-01

Cyber-bullying (where victims are targeted via online social networking or other electronic means) has gained increased attention in research and the broadcast media, but previous research has not investigated attribution of blame in such cyber-bullying events. This experiment hypothesized that participants would assign higher ratings of blame to bullying perpetrators when the bullying situations were depicted as having highly foreseeable outcomes (vs. unforeseeable outcomes), and as occurring in school (vs. online). In addition, a significant interaction was predicted between outcome foreseeability and bullying situation, with highly foreseeable in-school events being rated as the most predictable and attributable to the bully's actions. One-hundred sixty-three participants completed surveys containing demographic items, items regarding their past experiences of victimization, and one of four randomly-assigned vignettes detailing a bullying situation (which participants rated). While hypotheses regarding outcome foreseeability were supported, no cyber-bullying vs. in-school main effects (or corresponding interaction effects) were detected. Implications for future research and practice, as well as study limitations, are discussed. © 2013 The Scandinavian Psychological Associations.

A Randomized Controlled Trial to Improve Social Skills in Young Adults with Autism Spectrum Disorder: The UCLA PEERS(®) Program.

PubMed

Laugeson, Elizabeth A; Gantman, Alexander; Kapp, Steven K; Orenski, Kaely; Ellingsen, Ruth

2015-12-01

Research suggests that impaired social skills are often the most significant challenge for those with autism spectrum disorder (ASD), yet few evidence-based social skills interventions exist for adults on the spectrum. This replication trial tested the effectiveness of PEERS, a caregiver-assisted social skills program for high-functioning young adults with ASD. Using a randomized controlled design, 22 young adults 18-24 years of age were randomly assigned to a treatment (n = 12) or delayed treatment control (n = 10) group. Results revealed that the treatment group improved significantly in overall social skills, frequency of social engagement, and social skills knowledge, and significantly reduced ASD symptoms related to social responsiveness following PEERS. Most treatment gains were maintained at a 16-week follow-up assessment with new improvements observed.

Impact of pretest on posttest knowledge scores with a Solomon Four research design.

PubMed

Weinrich, Sally P; Seger, Rachelle; Curtsinger, Tim; Pumphrey, Gwen; NeSmith, Elizabeth G; Weinrich, Martin C

2007-01-01

There is a paucity of research on the effects of pretest measurement with prostate cancer screening. What effect does a pretest measurement have on posttest outcomes? This research reports knowledge of prostate cancer screening among men randomized to an Enhanced decision aid versus an Usual Care decision aid. Using a Solomon Four research design, there were a total of 198 men in 4 groups. Most of the sample was African American (78%), with a mean age of 52 years. The greatest posttest knowledge occurred with the Enhanced decision aid in contrast to the Usual Care. The Enhanced/Usual Care groups that had both a pretest and posttest and had received a previous digital rectal examination had the highest means (P = .015), with means of 9.1 and 7.0, respectively. Among men who had a previous digital rectal examination, the greatest increase in score occurred among men randomized to the Enhanced decision aid in contrast to the Usual Care decision aid, 2.9 versus 0.4 (P = .008). The outcome varied based on the status of (1) random group assignment of the Solomon Four design and (2) status of previous digital rectal examination. Implications for nurses include consideration 1 of a pretest to increase posttest knowledge scores.

Preventing Depression in Later Life: Translation From Concept to Experimental Design and Implementation

PubMed Central

Sriwattanakomen, Roy; Ford, Angela F.; Thomas, Stephen B.; Miller, Mark D.; Stack, Jacqueline A.; Morse, Jennifer Q.; Kasckow, John; Brown, Charlotte; Reynolds, Charles F.

2009-01-01

Objective The authors detail the public health need for depression prevention research and the decisions made in designing an experiment testing problem solving therapy as “indicated” preventive intervention for high-risk older adults with subsyndromal depression. Special attention is given to the recruitment of African Americans because of well-documented inequalities in mental health services and depression treatment outcomes between races. Methods A total of 306 subjects (half white, half African American) with scores of 16 or higher on the Center for Epidemiological Studies of Depression Scale, but with no history of major depressive disorder in the past 12 months, are being recruited and randomly assigned to either problem solving therapy-primary care or to a dietary education control condition. Time to, and rate of, incident episodes of major depressive disorder are to be modeled using survival analysis. Level of depressive symptoms will be analyzed via a mixed models approach. Results Twenty-two subjects have been recruited into the study, and to date eight have completed the randomly assigned intervention and postintervention assessment. Four of 22 have exited after developing major depressive episodes. None have complained about study procedures or demands. Implementation in a variety of community settings is going well. Conclusion The data collected to date support the feasibility of translating from epidemiology to RCT design and implementation of empirical depression prevention research in later life. PMID:18515690

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

PubMed

Young, Daniel K W; Kwok, Timothy C Y; Ng, Petrus Y N

2014-01-01

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. 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. 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. 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.

A Bayesian Nonparametric Causal Model for Regression Discontinuity Designs

ERIC Educational Resources Information Center

Karabatsos, George; Walker, Stephen G.

2013-01-01

The regression discontinuity (RD) design (Thistlewaite & Campbell, 1960; Cook, 2008) provides a framework to identify and estimate causal effects from a non-randomized design. Each subject of a RD design is assigned to the treatment (versus assignment to a non-treatment) whenever her/his observed value of the assignment variable equals or…

The effects of subliminal symbiotic stimulation on free-response and self-report mood.

PubMed

Weinberger, J; Kelner, S; McClelland, D

1997-10-01

Research has shown that subliminal presentation of MOMMY AND I ARE ONE (MIO) can help improve adaptive functioning. Two experiments tried to determine whether changes in mood, especially free-response mood, could help explain these findings. In one experiment, 20 men were randomly assigned to receive either a subliminal MIO or control stimulus. Results showed predicted effects on a free-response and no effects on a self-report mood measure. In the other experiment, 54 male subjects randomly received one of three subliminal stimuli. They evidenced the same pattern of mood results. Sentential semantics were shown to be relevant to the obtained results. Ascending threshold and 150 forced-choice discrimination trials demonstrated that subjects could not report stimulus content. It was concluded that MIO effects were attributable to unconscious processing of the entire message and that free-response mood may partly mediate these effects. Suggestions for future research were offered.

Frustration in Condensed Matter and Protein Folding

NASA Astrophysics Data System (ADS)

Lorelli, S.; Cabot, A.; Sundarprasad, N.; Boekema, C.

Using computer modeling we study frustration in condensed matter and protein folding. Frustration is due to random and/or competing interactions. One definition of frustration is the sum of squares of the differences between actual and expected distances between characters. If this sum is non-zero, then the system is said to have frustration. A simulation tracks the movement of characters to lower their frustration. Our research is conducted on frustration as a function of temperature using a logarithmic scale. At absolute zero, the relaxation for frustration is a power function for randomly assigned patterns or an exponential function for regular patterns like Thomson figures. These findings have implications for protein folding; we attempt to apply our frustration modeling to protein folding and dynamics. We use coding in Python to simulate different ways a protein can fold. An algorithm is being developed to find the lowest frustration (and thus energy) states possible. Research supported by SJSU & AFC.

Animal-Assisted Therapies for Youth with or at risk for Mental Health Problems: A Systematic Review.

PubMed

Hoagwood, Kimberly Eaton; Acri, Mary; Morrissey, Meghan; Peth-Pierce, Robin

2017-01-01

To systematically review experimental evidence about animal-assisted therapies (AAT) for children or adolescents with or at risk for mental health conditions, we reviewed all experimental AAT studies published between 2000-2015, and compared studies by animal type, intervention, and outcomes. Studies were included if used therapeutically for children and adolescents (≤21 years) with or at risk for a mental health problem; used random assignment or a waitlist comparison/control group; and included child-specific outcome data. Of 1,535 studies, 24 met inclusion criteria. Of 24 studies identified, almost half were randomized controlled trials, with 9 of 11 published in the past two years. The largest group addresses equine therapies for autism. Findings are generally promising for positive effects associated with equine therapies for autism and canine therapies for childhood trauma. The AAT research base is slim; a more focused research agenda is outlined.

A Scenario-Based Parametric Analysis of Stable Marriage Approaches to the Army Officer Assignment Problem

DTIC Science & Technology

2017-03-23

solutions obtained through their proposed method to comparative instances of a generalized assignment problem with either ordinal cost components or... method flag: Designates the method by which the changed/ new assignment problem instance is solved. methodFlag = 0:SMAWarmstart Returns a matching...of randomized perturbations. We examine the contrasts between these methods in the context of assigning Army Officers among a set of identified

Recruitment and Enrollment for the Simultaneous Conduct of 2 Randomized Controlled Trials for Patients with Subacute and Chronic Low Back Pain at a CAM Research Center

PubMed Central

Long, Cynthia R.; Haan, Andrea G.; Spencer, Lori Byrd; Meeker, William C.

2008-01-01

Abstract Objective To describe recruitment and enrollment experiences of 2 low back pain (LBP) randomized controlled trials (RCTs). Design Descriptive report. Setting Chiropractic research center in the midwest United States that is not a fee-for-service clinic. Participants Both trials enrolled participants with subacute or chronic LBP without neurologic signs who had not received spinal manipulative care during the previous month. For study 1 we screened 1940 potential participants to enroll 192 participants (89 women and 103 men), mean age 40.0 ± 9.4 years (range, 21–54 years). For study 2 we screened 1849 potential participants to enroll 240 participants (105 women and 135 men) at least 55 years old (mean, 63.1 ± 6.7 years). Interventions Study 1 randomly assigned participants to 2 weeks of 2 different chiropractic techniques or a wait list control group. Study 2 randomly assigned participants to 6 weeks of 2 different chiropractic techniques or medical care consisting of 3 provider visits for medications. Outcome measures Recruitment source costs and yield, and baseline characteristics of enrolled versus nonparticipants were recorded. Results We conducted 3789 telephone screens for both trials to enroll 432 (11%) participants, at a cost in excess of $156,000 for recruitment efforts. The cost per call for all callers averaged $41, ranging from $4 to $300 based on recruitment method; for enrolled participants, the cost per call was $361, ranging from $33 to $750. Direct mail efforts accounted for 62% of all callers, 57% for enrolled participants, and had the second lowest cost per call for recruitment efforts. Conclusions It is important that complementary and alternative medicine (CAM) research can be successfully conducted at CAM institutions. However, the costs associated with recruitment efforts for studies conducted at CAM institutions may be higher than expected and many self-identified participants are users of the CAM therapy. Therefore, strategies for efficient recruitment methods and targeting nonusers of CAM therapies should be developed early for CAM trials. PMID:18990046

Viruses, Vaccines and the Public

PubMed Central

Diamond, Judy; McQuillan, Julia; Spiegel, Amy N.; Hill, Patricia Wonch; Smith, Rebecca; West, John; Wood, Charles

2016-01-01

Current research in virology is changing public conceptions about vaccines and infectious disease. The University of Nebraska State Museum collaborated with research virologists, science writers, artists and learning researchers to create public outreach materials about viruses and infectious disease. The project, funded by the National Institute of Health’s SEPA program, developed comics, a book with Carl Zimmer, and other materials and programs. The project launched three kinds of learning research: 1) a survey of Nebraska adults on their opinions about vaccines and infectious disease; 2) a study comparing the mental models of viruses, vaccines and infection from virologists, teachers, and students; and 3) a controlled study 873 high school students randomly assigned to read either a comic or a text-based essay with the same virus information. PMID:27524953

Viruses, Vaccines and the Public.

PubMed

Diamond, Judy; McQuillan, Julia; Spiegel, Amy N; Hill, Patricia Wonch; Smith, Rebecca; West, John; Wood, Charles

Current research in virology is changing public conceptions about vaccines and infectious disease. The University of Nebraska State Museum collaborated with research virologists, science writers, artists and learning researchers to create public outreach materials about viruses and infectious disease. The project, funded by the National Institute of Health's SEPA program, developed comics, a book with Carl Zimmer, and other materials and programs. The project launched three kinds of learning research: 1) a survey of Nebraska adults on their opinions about vaccines and infectious disease; 2) a study comparing the mental models of viruses, vaccines and infection from virologists, teachers, and students; and 3) a controlled study 873 high school students randomly assigned to read either a comic or a text-based essay with the same virus information.

Ethical Issues for Control-Arm Patients After Revelation of Benefits of Experimental Therapy: A Framework Modeled in Neuroblastoma

PubMed Central

Unguru, Yoram; Joffe, Steven; Fernandez, Conrad V.; Yu, Alice L.

2013-01-01

In 2009, the Children's Oncology Group (COG) phase III randomized controlled trial, ANBL0032, found that adding immunotherapy (Ch14.18) to standard therapy significantly improved outcomes in patients with high-risk neuroblastoma when administered within 110 days after autologous stem-cell transplantation (SCT). After careful deliberation and consultation, the COG Neuroblastoma Committee decided to offer Ch14.18 to prior trial participants who had been randomly assigned to the control arm (no immunotherapy), regardless of the time that had elapsed since SCT. This decision occurred in the context of a limited supply of Ch14.18 and no data regarding its role when administered beyond 110 days. In this article, we analyze the numerous ethical challenges highlighted by the ANBL0032 trial, including the limits of researchers' reciprocity-based obligations to study participants, post-trial access to beneficial therapies, and the balance between scientific knowledge and parental hope. These deliberations may be useful to other researchers when considering their ethical obligations to control-arm participants in the wake of a positive randomized trial. PMID:23295797

Effects of a Pedagogical Agent's Emotional Expressiveness on Learner Perceptions

NASA Technical Reports Server (NTRS)

Romero, Enilda J.; Watson, Ginger S.

2012-01-01

The use of animated pedagogical agents or avatars in instruction has lagged behind their use in entertainment. This is due in part to the cost and complexity of development and implementation of agents in educational settings, but also results from a lack of research to understand how emotions from animated agents influence instructional effectiveness. The phenomenological study presented here assesses the perceptions of eight learners interacting with low and high intensity emotionally expressive pedagogical agents in a computer-mediated environment. Research methods include maximum variation and snowball sampling with random assignment to treatment. The resulting themes incorporate perceptions of importance, agent humanness, enjoyment, implementation barriers, and suggested improvements. Design recommendations and implications for future research are presented.

Early removal of urethral catheter with suprapubic tube drainage versus urethral catheter drainage alone after robot-assisted laparoscopic radical prostatectomy.

PubMed

Prasad, Sandip M; Large, Michael C; Patel, Amit R; Famakinwa, Olufenwa; Galocy, R Matthew; Karrison, Theodore; Shalhav, Arieh L; Zagaja, Gregory P

2014-07-01

Retrospective single institution data suggest that postoperative pain after robot-assisted laparoscopic radical prostatectomy is decreased by early removal of the urethral catheter with suprapubic tube drainage. In a randomized patient population we determined whether suprapubic tube drainage with early urethral catheter removal would improve postoperative pain compared with urethral catheter drainage alone. Men with a body mass index of less than 40 kg/m(2) who had newly diagnosed prostate cancer and elected robot-assisted laparoscopic radical prostatectomy were included in analysis. Block randomization by surgeon was used and randomization assignment was done after completing the urethrovesical anastomosis. In patients assigned to suprapubic tube drainage the urethral catheter was removed on postoperative day 1 and all catheters were removed on postoperative day 7. Visual analog pain scale and satisfaction questionnaires were administered on postoperative days 0, 1 and 7. A total of 29 patients were randomized to the urethral catheter vs 29 to the suprapubic tube plus early urethral catheter removal at the time of interim futility analysis. Mean visual analog pain scale scores did not differ between the groups at any time point and a similar percent of patients cited the catheter as the greatest bother with nonsignificant differences in treatment related satisfaction. Complications during postoperative week 1 did not vary between the groups. Based on interim results the trial was terminated due to lack of effect. Patients randomized to suprapubic tube vs urethral catheter drainage for the week after prostatectomy had similar pain, catheter related bother and treatment related satisfaction in the perioperative period. We no longer routinely offer suprapubic tube drainage with early urethral catheter removal at our institution. Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Peer Grading in Astronomy Massive Open Online Course

NASA Astrophysics Data System (ADS)

Formanek, Martin; Wenger, Matthew; Impey, Christopher; Buxner, Sanlyn

In this work we thoroughly investigate the peer grading process as it happened in the University of Arizona session based MOOC ``Astronomy: Exploring Time and Space'' offered during Spring 2015 through Coursera. Overall, 25400 learners from over 100 countries registered for this course. Of those, 14900 accessed at least one part of the course and 1332 users engaged in the peer grading. First of all we provide description of the peer graded assignments and we identify trends in behavior of people who participated in these exercises. E.g. time they spent on grading, number of assignments graded and patterns arising from comparing all three assignments. Furthermore, for the second assignment, we graded random sample of 300 essays by a group of trained undergraduate students and a group consisting of one of the course instructors together with graduate TAs and we compared results with grades from the peer grading. Specifically we look on Intraclass Correlation Coefficients for all three groups of graders to determine reliability of each group and correlations between final grades. Finally we assess factors influencing reliability of the peer graders participating in the MOOC based on the difference from our grades. This research was supported by Howard Hughes Medical Institute Grant No. 415580.

Caregiver Satisfaction with a Multisite Trial of Atomoxetine and Parent Training for Attention-Deficit/Hyperactivity Disorder and Behavioral Noncompliance in Children with Autism Spectrum Disorder

PubMed Central

Aman, Michael G.; Mendoza-Burcham, Marissa I.; Silverman, Laura; Arnold, L. Eugene; Tumuluru, Rameshwari; Handen, Benjamin L.; Lecavalier, Luc; Page, Kristin; Sayre, Pamela; Smith, Tristram

2016-01-01

Abstract Objective: The purpose of this study was to examine caregiver satisfaction with the research experience in a randomized clinical trial of atomoxetine (ATX) and parent training (PT) for attention-deficit/hyperactivity disorder (ADHD) and behavioral noncompliance co-occurring with autism. Methods: The Children with Hyperactivity and Autism Research Treatment Study (CHARTS) randomly assigned 128 children 5.00–14.11 years of age to four treatment groups (ATX + PT, ATX alone, PT + placebo[PBO], and PBO). Caregivers completed an 18 item questionnaire about their satisfaction with the research experience. We summarized caregiver responses with descriptive statistics and examined whether the responses were associated with demographic variables, treatment assignment, or the child's response to treatment (positive or negative). Results: Ninety-three percent of caregivers (119) completed the questionnaire. When asked if they would join the study again if given the chance, 87% (103) responded “yes,” 13% (15) responded “maybe,” and 1% (1) responded “no.” When asked if they would recommend the study to other caregivers of children with similar problems, 92% (109) responded “yes” and 8% responded (10) “maybe.” Of the 59 Parent Satisfaction Questionnaire (PSQ) respondents who received PT, 75% (44) felt more confident in managing current child behaviors, 24% (14) felt that their level of confidence was unchanged, and 2% (1) felt less confident. Most caregivers expressed satisfaction with the study procedures, including the number of visits and the safety monitoring protocols. Conclusions: In general, caregivers were highly satisfied with their research experience. These findings may be useful for informing human subject committees and for designing study protocols that are appealing to families. PMID:26797318

DEVELOPING AN IPAD® APPLICATION FOR DATA COLLECTION IN A RHEUMATOLOGY RESEARCH CLINIC.

PubMed

Kaka, Hussam; Ayearst, Renise; Tran, Maithy; Touma, Zahi; Bagovich, Maria; Vinik, Ophir; Somaily, Mansour; Haddad, Amir; Gladman, Dafna D; Chandran, Vinod

2015-01-01

Clinical research data are often collected on paper and later inputted onto an electronic database. This method is time consuming and potentially introduces errors. Therefore, to make primary data collection more efficient and less error prone we aimed to develop a touch-screen application for data collection in a psoriatic arthritis research clinic and compared it with the pre-existing paper-based system. We developed a Web application using Java and optimized it for the iPad®. It highlights missing fields for physicians in real time, and only permits submission of data collection form after corrections are made. For its evaluation, seven physicians participated, and before each patient visit they were randomly assigned paper or iPad® data entry. Number of errors, length of visit, and time between clinic visit and completion of data entry were measured. A total of 106 patients seen in the clinic who agreed to participate were randomly assigned to be evaluated by clinic physicians using the iPad® (fifty-three patients) or a paper protocol (fifty-three patients). On average, 3.34 omissions were found per paper form, of which 2.24 would have been detected on the iPad®. The iPad® increased the mean patient encounter time from 37.2 minutes to 46.5 minutes, but eliminated delay between a clinic visit and its data entry. Entering data using the iPad® application makes the patient encounter slightly longer, but reduces "missing fields." It also eliminates the delay between clinic visit and data entry thus improving the efficiency of clinical data capture in a research setting.

A Randomized Control Study on Psycho-Education Group on Improving Health-Related Quality of Life of Chinese Persons with Major Neurocognitive Disorder.

PubMed

Young, Kim-Wan

2016-01-01

People with a major neurocognitive disorder (PwND) are found to have a lower health related quality of life (HRQoL) than those without neurocognitive disorder. This research study aims to evaluate the effectiveness of a psycho-education group in improving the HRQoL of Chinese PwND. By adopting randomized control trial (RCT), Chinese PwND were randomly assigned to either a 10-session psycho-education group or the control group. Family caregivers of treatment group were encouraged to take part in two sessions focusing on the caring and communication skills. Control group and their family caregivers received standardized educational materials on basic information on neurocognitive disorder for them to read at home. Standardized assessment was conducted both with PwND and their caregivers independently to give the self-rated and caregiver-rated HRQoL of PwND in the pre- and post- treatment periods by a research assistant who was blind to the group assignment of the participants. Moreover, qualitative interviews were also conducted for ten participants and five family caregivers of the treatment group to identify those group elements relating to its effectiveness. 2 × 2 repeated measures ANCOVA demonstrated that the treatment group (n = 32) was significantly more effective than the control group (n = 32) in improving the caregiver-rated HRQoL (F[1, 61] = 4.35, p = .04 < .05) with a moderate effect size, but not self-rated HRQoL, Qualitative analysis suggested several group elements relating to its effectiveness. This present RCT shows that the psycho-education group significantly improves caregiver-rated HRQoL of PwND, supporting the feasibility and effectiveness of the psycho-education group.

Patient-controlled methylphenidate for cancer fatigue: a double-blind, randomized, placebo-controlled trial.

PubMed

Bruera, Eduardo; Valero, Vicente; Driver, Larry; Shen, Loren; Willey, Jie; Zhang, Tao; Palmer, J Lynn

2006-05-01

To evaluate the effectiveness of patient-controlled methylphenidate as compared with placebo in cancer patients with fatigue, as measured by the Functional Assessment for Chronic Illness Therapy-Fatigue (FACIT-F). Patients with a fatigue score of at least 4 on a scale of 0 to 10 (0 = no fatigue, 10 = worst possible fatigue) and hemoglobin level of at least 10 g/dL were included. Patients were randomly assigned to receive 5 mg methylphenidate or placebo every 2 hours as needed (maximum of four capsules a day), for 7 days. Patients completed a daily diary including study drug record and fatigue intensity. A research nurse telephoned patients daily to assess toxicity and fatigue level. All patients were offered open-label methylphenidate for 4 weeks. FACIT-F and the Edmonton Symptom Assessment System (ESAS) were assessed at baseline, and days 8, 15, and 36. The FACIT-F fatigue subscore on day 8 was considered the primary end point. Of 112 patients randomly assigned, 52 patients in the methylphenidate and 53 in the placebo group were assessable for analysis. Fatigue intensity improved significantly on day 8 in both the methylphenidate and placebo groups. However, there was no significant difference in fatigue improvement by FACIT-F (P = .31) or ESAS (P = .14) between groups. In open-label phase, fatigue intensity maintained low as compared with baseline. No significant toxicities were observed. Both methylphenidate and placebo resulted in significant symptom improvement. Methylphenidate was not significantly superior to placebo after 1 week of treatment. Longer study duration is justified. The role of daily telephone calls from a research nurse should be explored as a palliative care intervention.

Effects of calcium supplementation on body weight and adiposity in overweight and obese adults: a randomized trial.

PubMed

Yanovski, Jack A; Parikh, Shamik J; Yanoff, Lisa B; Denkinger, Blakeley I; Calis, Karim A; Reynolds, James C; Sebring, Nancy G; McHugh, Teresa

2009-06-16

Some data suggest that increasing calcium intake may help prevent weight gain. To test the hypothesis that calcium supplementation can prevent weight gain in persons who are overweight or obese. Randomized, placebo-controlled trial. Randomization was computer-generated, and allocation was assigned by pharmacy personnel who prepared intervention and placebo capsules. Participants, providers, and those who assessed outcomes were blinded to study group assignment. Single research center. 340 overweight (body mass index [BMI], 25 to <30 kg/m(2)) and obese (BMI > or =30 kg/m(2)) adults (mean age, 38.8 years [SD, 10.5]). Calcium carbonate (elemental calcium, 1500 mg/d) (n = 170) or placebo (n = 170) with meals for 2 years. Changes in body weight and fat mass (primary outcomes). Seventy-five percent of participants completed the trial (78% received calcium; 73% received placebo). There were no statistically or clinically significant differences between the calcium and placebo groups in change in body weight (difference, 0.02 kg [95% CI, -1.64 to 1.69 kg]; P = 0.98), BMI (difference, 0.32 kg/m(2) [CI, -0.41 to 1.02 kg/m(2)]; P = 0.39), or body fat mass (difference, 0.39 kg [CI, -1.04 to 1.92 kg]; P = 0.55). Parathyroid hormone concentrations decreased in the calcium group compared with the placebo group (difference, -0.71 pmol/L [CI, -1.28 to -0.13 pmol/L]). The study took place at a research center, and its sample was mostly women. Dietary supplementation with elemental calcium, 1500 mg/d, for 2 years had no statistically or clinically significant effects on weight in overweight and obese adults. Calcium supplementation is unlikely to have clinically significant efficacy as a preventive measure against weight gain in such patients.

Long-term effects of course-embedded undergraduate research: The CASPiE longitudinal study

NASA Astrophysics Data System (ADS)

Szteinberg, Gabriela A.

The Center for Authentic Science Practice in Education (CASPiE) is a National Science Foundation funded initiative that seeks to introduce first- and second-year undergraduate students to research in their mainstream laboratory courses. To investigate the effects of this research-based curriculum, a longitudinal study was initiated at Purdue University (PU) and University of Illinois-Chicago (UIC), where CASPiE was implemented in a portion of laboratory sections of a general chemistry course (CHEM 116 at PU/CHEM 114 at UIC). The study examined the long-term effects of the CASPiE program on students' chemistry course performance, research involvement, and retention in STEM majors and future careers. The results of the academic records analyses showed that PU CASPiE students from the opt-in semesters, i.e. those when students chose to enroll in the CASPiE sections, were higher-achieving students from the beginning of their college years and performed significantly higher than the students in the traditional sections. There were no significant differences in chemistry course performance among PU students from the randomly assigned semester. However, looking from the first semester chemistry course to the upper 300 level chemistry courses, randomly assigned PU students from the traditional sections had a significant performance decrease. The CASPiE students had a performance decrease that was not significant. At UIC, there were no significant differences between CASPiE and traditional students' chemistry performance. Analyses of the academic records also revealed that there were no differences in STEM major retention between CASPiE and traditional students, from both PU and UIC. However, CASPiE students from UIC and the ones from the opt-in sections at PU graduated faster in average than traditional students. Students' responses to an online survey showed that there were no differences in students' choice of future plans in STEM or non-STEM fields (such as graduate or professional school, or type of job). Interviews with PU's CASPiE and traditional students revealed that CASPiE students thought their laboratory work was applicable and relevant to other research and their lives and they tended to remember their lab activities more than the traditional students. CASPiE students thought the lab work they did was rewarding and they felt a sense of accomplishment. CASPiE students from the randomly assigned semester thought the experience was rewarding in retrospect, which is an important finding because during that semester students were frustrated that they were not able to choose their participation in CASPiE. Traditional students thought their lab experience helped prepare them for future courses at PU, whereas CASPiE students thought they were better prepared for class and lab in general, they learned how to keep a research notebook and write scientific papers, and that overall they learned how to conduct research. Specifically, CASPiE students thought they were able to use creativity in their lab. Both students from CASPiE and traditional sections thought they learned how to work well in groups through their lab experiences. Based on the results, we can conclude that CASPiE was successful at providing first- and second-year students with research experiences in their second-semester general chemistry class, without negatively affecting their chemistry course performance, retention in STEM majors or future plans. PU CASPiE students from the opt-in years were higher-achieving students than the traditional counterparts therefore the significant differences in chemistry performance between these students are not surprising. The CASPiE curriculum did seem to have had an enhancing effect on the randomly assigned PU CASPiE students' chemistry performance over the years. Furthermore, CASPiE students from PU reported gains from doing research experiences that have previously been reported in the literature on undergraduate research experiences. The results from this study show that CASPiE could be a beneficial curriculum for STEM college educators who wish to have more students practice research during their college courses. (Abstract shortened by UMI.)

Donepezil for cancer fatigue: a double-blind, randomized, placebo-controlled trial.

PubMed

Bruera, Eduardo; El Osta, Badi; Valero, Vicente; Driver, Larry C; Pei, Be-Lian; Shen, Loren; Poulter, Valerie A; Palmer, J Lynn

2007-08-10

To evaluate the effectiveness of donepezil compared with placebo in cancer patients with fatigue as measured by the Functional Assessment for Chronic Illness Therapy-Fatigue (FACIT-F). Patients with fatigue score >or= 4 on a scale of 0 to 10 (0 = no fatigue, 10 = worst possible fatigue) for more than 1 week were included. Patients were randomly assigned to receive donepezil 5 mg or placebo orally every morning for 7 days. A research nurse contacted the patients by telephone daily to assess toxicity and fatigue level. All patients were offered open-label donepezil during the second week. FACIT-F and/or the Edmonton Symptom Assessment System (ESAS) were assessed at baseline, and days 8, 11, and 15. The FACIT-F fatigue subscale score on day 8 was considered the primary end point. Of 142 patients randomly assigned to treatment, 47 patients in the donepezil group and 56 in the placebo group were assessable for final analysis. Fatigue intensity improved significantly on day 8 in both donepezil and placebo groups. However, there was no significant difference in fatigue improvement by FACIT-F (P = .57) or ESAS (P = .18) between groups. In the open-label phase, fatigue intensity continued to be low as compared with baseline. No significant toxicities were observed. Donepezil was not significantly superior to placebo in the treatment of cancer-related fatigue.

THE EFFECTS OF INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION ON LOWER EXTREMITY MUSCLE PERFORMANCE: A RANDOMIZED CONTROLLED TRIAL.

PubMed

MacDonald, Nicole; Baker, Russell; Cheatham, Scott W

2016-12-01

Instrument-Assisted Soft Tissue Mobilization (IASTM) is a non-invasive therapeutic technique used to theoretically aid in scar tissue breakdown and absorption, fascial mobilization, and improved tissue healing. Researchers have hypothesized that utilizing IASTM will improve muscular efficiency and performance; yet previous Investigations has been focused on treating injury. The purpose of this investigation was to explore the effects of IASTM on muscle performance to assess if typical treatment application affected measures of muscular performance. A pretest-posttest randomized control design. A convenience sample of 48 physically active adults (mean age 24 ± 4 years), randomly assigned to one of three groups: quadriceps treatment group, triceps surae treatment group, or control group. Participants performed a five-minute warm-up on a Monark bicycle ergometer before performing three countermovement vertical jumps (CMJ). Immediately after, the IASTM treatment was applied by one researcher for three minutes on each leg at the specified site (e.g., quadriceps) for those assigned to the treatment groups, while the control group rested for six minutes. Immediately following treatment, participants performed three additional CMJs. Pre- and post-testing included measures of vertical jump height (JH), peak power (PP) and peak velocity (PV). There were no statistically significant differences found between treatment groups in JH, PP, or PV or across pre- and post-test trials. These preliminary findings suggest that standard treatment times of IASTM do not produce an immediate effect in muscular performance in healthy participants. This may help clinicians determine the optimal sequencing of IASTM when it is part of a pre-performance warm-up program. Future research should be conducted to determine the muscle performance effects of IASTM in individuals with known myofascial restriction and to determine optimal treatment parameters, such as instrument type, amount of pressure, and treatment time necessary to affect muscular performance. 1b.

Neural Mechanisms of Cognitive-Behavioral Therapy for Aggression in Children and Adolescents: Design of a Randomized Controlled Trial Within the National Institute for Mental Health Research Domain Criteria Construct of Frustrative Non-Reward

PubMed Central

Wyk, Brent C. Vander; Eilbott, Jeffrey A.; McCauley, Spencer A.; Ibrahim, Karim; Crowley, Michael J.; Pelphrey, Kevin A.

2016-01-01

Abstract Objective: We present the rationale and design of a randomized controlled trial of cognitive-behavioral therapy (CBT) for aggression in children and adolescents, which is conducted in response to the National Institute of Mental Health (NIMH) Research Domain Criteria (RDoC) approach initiative. Specifically, the study is focused on the brain-behavior associations within the RDoC construct of frustrative non-reward. On the behavioral level, this construct is defined by reactions elicited in response to withdrawal or prevention of reward, most notably reactive aggression. This study is designed to test the functional magnetic resonance (fMRI) and electrophysiological (EEG) correlates of aggression and its reduction after CBT. Methods: Eighty children and adolescents with high levels of aggression across multiple traditional diagnostic categories, ages 8–16, will be randomly assigned to receive 12 sessions of CBT or 12 sessions of supportive psychotherapy. Clinical outcomes will be measured by the ratings of aggressive behavior collected at baseline, midpoint, and endpoint evaluations, and by the Improvement Score of the Clinical Global Impressions Scale assigned by an independent evaluator (blinded rater). Subjects will also perform a frustration-induction Go-NoGo task and a task of emotional face perception during fMRI scanning and EEG recording at baseline and endpoint. Results: Consistent with the NIMH strategic research priorities, if functional neuroimaging and EEG variables can identify subjects who respond to CBT for aggression, this can provide a neuroscience-based classification scheme that will improve treatment outcomes for children and adolescents with aggressive behavior. Conclusions: Demonstrating that a change in the key nodes of the emotion regulation circuitry is associated with a reduction of reactive aggression will provide evidence to support the validity of the frustrative non-reward construct. PMID:26784537

A randomized study of a method for optimizing adolescent assent to biomedical research.

PubMed

Annett, Robert D; Brody, Janet L; Scherer, David G; Turner, Charles W; Dalen, Jeanne; Raissy, Hengameh

2017-01-01

Voluntary consent/assent with adolescents invited to participate in research raises challenging problems. No studies to date have attempted to manipulate autonomy in relation to assent/consent processes. This study evaluated the effects of an autonomy-enhanced individualized assent/consent procedure embedded within a randomized pediatric asthma clinical trial. Families were randomly assigned to remain together or separated during a consent/assent process; the latter we characterize as an autonomy-enhanced assent/consent procedure. We hypothesized that separating adolescents from their parents would improve adolescent assent by increasing knowledge and appreciation of the clinical trial and willingness to participate. Sixty-four adolescent-parent dyads completed procedures. The together versus separate randomization made no difference in adolescent or parent willingness to participate. However, significant differences were found in both parent and adolescent knowledge of the asthma clinical trial based on the assent/consent procedure and adolescent age. The separate assent/consent procedure improved knowledge of study risks and benefits for older adolescents and their parents but not for the younger youth or their parents. Regardless of the assent/consent process, younger adolescents had lower comprehension of information associated with the study medication and research risks and benefits, but not study procedures or their research rights and privileges. The use of an autonomy-enhanced assent/consent procedure for adolescents may improve their and their parent's informed assent/consent without impacting research participation decisions. Traditional assent/consent procedures may result in a "diffusion of responsibility" effect between parents and older adolescents, specifically in attending to key information associated with study risks and benefits.

Parent satisfaction in a multi-site acute trial of risperidone in children with autism: a social validity study.

PubMed

Tierney, Elaine; Aman, Michael; Stout, David; Pappas, Krista; Arnold, L Eugene; Vitiello, Benedetto; Scahill, Lawrence; McDougle, Christopher; McCracken, James; Wheeler, Courtney; Martin, Andres; Posey, David; Shah, Bhavik

2007-03-01

Subjects who view experimental procedures as worthwhile are more likely to participate in clinical trials and comply with study procedures. Designing studies that consider the consumer's perspective will help to forge a better alliance between participants and researchers. Participant satisfaction is seldom assessed in pharmacological research. In this paper, we report on parent satisfaction in a randomized clinical trial in children with autistic disorder and severely disruptive behavior. Parents of 101 children with autism who had participated in a multi-site 8-week double-blind clinical trial of risperidone were given a questionnaire at the end to elicit their perceptions of the appropriateness and acceptability of clinical trial procedures. Ninety-six (95.0%) parents returned the questionnaire. Of these, 80.0 to 96.8%, depending on the question, expressed satisfaction with their child's research participation regardless of treatment outcome or assignment to active drug or placebo. In all, 90.5% of parents indicated that they would "definitely" recommend the clinical trial to other families with similar children. A total of 92.7% indicated that they would rejoin the clinical trial if they had to do it all over again. Ethnic minority subjects were more satisfied than white participants with the use of "learning tests". Parents of children participating in this trial were highly satisfied and supportive of the clinical trial procedures. Random assignment to drug or placebo and the clinical response of their children did not appear to influence their views. Further satisfaction studies of this sort are encouraged.

High Power Distance Enhances Employees' Preference for Likable Managers: A Resource Dependency Perspective

PubMed Central

Wei, Cong; Sun, Xiaomin; Liu, Jia; Zhou, Chunfang; Xue, Gang

2017-01-01

Is a manager's likability important from an employee's perspective? Research results in this field are scant and inconsistent. The current study explored employees' response to managers' likability and the moderating effect of power distance at both the cultural and individual levels. In study 1, following the countercultural priming experimental paradigm proposed by Van den Bos et al. (2013), 121 college students from China (a high power distance culture) and 99 college students from Denmark (a low power distance culture) were randomly assigned to either a countercultural (experimental) condition or a control condition. All participants were required to complete a manager selection task using the zero-acquaintance paradigm to measure their preference for likable managers. The results confirmed the moderating role of power distance at the cultural level. Study 2 further explored the moderating effect of power distance orientation at the individual level, as well as the boundary condition of the degree of resource dependence from the employee's perspective. One hundred and three Chinese participants with work experience were randomly assigned to either the subordinate perspective (high resource dependence) or the HR department perspective (low resource dependence) condition and completed the same task as in study 1. The results suggested that high power distance-oriented participants demonstrate stronger preference for likable manager candidates than do low power distance-oriented participants. In addition, these findings hold only when employees expect a high resource dependence relation with the manager. Theoretical and practical implications of the research findings and future research directions were discussed. PMID:28119654

Using Medicare Data for Comparative Effectiveness Research – Opportunities and Challenges

PubMed Central

Fung, Vicki; Brand, Richard; Newhouse, Joseph; Hsu, John

2013-01-01

Background With the introduction of Part D drug benefits, Medicare collects information on diagnoses, treatments, and clinical events for millions of beneficiaries. These data are a promising resource for comparative effectiveness research (CER) on treatments, benefit designs, and delivery systems. Objectives We explore the data available for researchers and approaches that could be used to enhance the value of Medicare data for CER. Challenges and Opportunities Using currently available Medicare data for CER is challenging; as with all administrative data, it is not possible to capture every factor that contributes to prescribing decisions and patients are not randomly assigned to treatments. In addition, Part D plan selection and switching may influence treatment decisions and contribute to selection bias. Exploiting certain program aspects can help address these limitations. For example, ongoing changes in Medicare or plan policies, and the random assignment of beneficiaries who receive Part D low income subsidies into plans with different formularies could yield natural experiments. Policy implications Refining policies around time to data release, provision of additional data elements, and linkage with greater beneficiary-level information would improve the value and usability of these data. Improving the transparency and reproduceability of findings, and potential open access to qualified stakeholders are also important policy considerations. Work is needed to reconcile data needs with current policies and goals. Conclusions Medicare data provides a rich resource for CER. Leveraging existing program elements combined with some administrative changes in data availability could create large datasets for evaluating treatment patterns, spending, and coverage decisions. PMID:21819169

Increasing participation in prevention research: strategies for youths, parents, and schools.

PubMed

Hooven, Carole; Walsh, Elaine; Willgerodt, Mayumi; Salazar, Amy

2011-08-01

Subject participation is a critical concern for clinicians and researchers involved in prevention programs, especially for intensive interventions that require randomized assignment and lengthy youth and parent involvement. This article describes details of an integrated approach used to recruit and retain at-risk high school youths, their parents, and high schools to two different comprehensive, "indicated" prevention programs. Parent and youth recruitment and retention data for the two studies is provided in support of the approach described. A coordinated, multilevel approach, organized around cross-cutting issues, is described in detail as a response to the challenges of including vulnerable populations in intervention research. Methods are relevant to nurse clinicians who deliver prevention programs, and are important to clinical research that relies upon adequate participation in research programs. © 2011 Wiley Periodicals, Inc.

Reliability of routinely collected hospital data for child maltreatment surveillance.

PubMed

McKenzie, Kirsten; Scott, Debbie A; Waller, Garry S; Campbell, Margaret

2011-01-05

Internationally, research on child maltreatment-related injuries has been hampered by a lack of available routinely collected health data to identify cases, examine causes, identify risk factors and explore health outcomes. Routinely collected hospital separation data coded using the International Classification of Diseases and Related Health Problems (ICD) system provide an internationally standardised data source for classifying and aggregating diseases, injuries, causes of injuries and related health conditions for statistical purposes. However, there has been limited research to examine the reliability of these data for child maltreatment surveillance purposes. This study examined the reliability of coding of child maltreatment in Queensland, Australia. A retrospective medical record review and recoding methodology was used to assess the reliability of coding of child maltreatment. A stratified sample of hospitals across Queensland was selected for this study, and a stratified random sample of cases was selected from within those hospitals. In 3.6% of cases the coders disagreed on whether any maltreatment code could be assigned (definite or possible) versus no maltreatment being assigned (unintentional injury), giving a sensitivity of 0.982 and specificity of 0.948. The review of these cases where discrepancies existed revealed that all cases had some indications of risk documented in the records. 15.5% of cases originally assigned a definite or possible maltreatment code, were recoded to a more or less definite strata. In terms of the number and type of maltreatment codes assigned, the auditor assigned a greater number of maltreatment types based on the medical documentation than the original coder assigned (22% of the auditor coded cases had more than one maltreatment type assigned compared to only 6% of the original coded data). The maltreatment types which were the most 'under-coded' by the original coder were psychological abuse and neglect. Cases coded with a sexual abuse code showed the highest level of reliability. Given the increasing international attention being given to improving the uniformity of reporting of child-maltreatment related injuries and the emphasis on the better utilisation of routinely collected health data, this study provides an estimate of the reliability of maltreatment-specific ICD-10-AM codes assigned in an inpatient setting.

Reliability of Routinely Collected Hospital Data for Child Maltreatment Surveillance

PubMed Central

2011-01-01

Background Internationally, research on child maltreatment-related injuries has been hampered by a lack of available routinely collected health data to identify cases, examine causes, identify risk factors and explore health outcomes. Routinely collected hospital separation data coded using the International Classification of Diseases and Related Health Problems (ICD) system provide an internationally standardised data source for classifying and aggregating diseases, injuries, causes of injuries and related health conditions for statistical purposes. However, there has been limited research to examine the reliability of these data for child maltreatment surveillance purposes. This study examined the reliability of coding of child maltreatment in Queensland, Australia. Methods A retrospective medical record review and recoding methodology was used to assess the reliability of coding of child maltreatment. A stratified sample of hospitals across Queensland was selected for this study, and a stratified random sample of cases was selected from within those hospitals. Results In 3.6% of cases the coders disagreed on whether any maltreatment code could be assigned (definite or possible) versus no maltreatment being assigned (unintentional injury), giving a sensitivity of 0.982 and specificity of 0.948. The review of these cases where discrepancies existed revealed that all cases had some indications of risk documented in the records. 15.5% of cases originally assigned a definite or possible maltreatment code, were recoded to a more or less definite strata. In terms of the number and type of maltreatment codes assigned, the auditor assigned a greater number of maltreatment types based on the medical documentation than the original coder assigned (22% of the auditor coded cases had more than one maltreatment type assigned compared to only 6% of the original coded data). The maltreatment types which were the most 'under-coded' by the original coder were psychological abuse and neglect. Cases coded with a sexual abuse code showed the highest level of reliability. Conclusion Given the increasing international attention being given to improving the uniformity of reporting of child-maltreatment related injuries and the emphasis on the better utilisation of routinely collected health data, this study provides an estimate of the reliability of maltreatment-specific ICD-10-AM codes assigned in an inpatient setting. PMID:21208411

Web-based proactive system to improve breast cancer screening: a randomized controlled trial.

PubMed

Chaudhry, Rajeev; Scheitel, Sidna M; McMurtry, Erin K; Leutink, Dorinda J; Cabanela, Rosa L; Naessens, James M; Rahman, Ahmed S; Davis, Lynn A; Stroebel, Robert J

2007-03-26

Screening mammography is recommended for early detection of breast cancer but screening rates remain suboptimal. A primary care portal for a large academic primary practice was developed for all preventive services. Another Web-based system (PRECARES [PREventive CAre REminder System]) was developed for appointment secretaries to manage proactive breast cancer screening. Female patients aged 40 to 75 years were randomly assigned to a control group (usual care) and an intervention group. For the intervention group, 2 monthly letters inviting patients to undergo mammography were sent starting 3 months before they were due for annual screening, followed by a telephone call to nonresponding patients. A subgroup of women employees was further randomized to receive a reminder by either US mail or e-mail. Of the total eligible population of 6665 women identified as having consented to participate in research, 3339 were randomly assigned to the control group and 3326 to the intervention group. The screening rate for annual mammography was 64.3% for the intervention group and 55.3% for the control group (P <.001). There were no significant differences between the 2 groups for any of the other adult preventive services. For the employee subgroup, the screening rate was 57.5% for the control group, 68.1% for the US mail group, and 72.2% for the e-mail group (intervention vs control, P <.001; e-mail vs US mail; P = .24). The breast cancer screening rate improved significantly with the practice redesign of having appointment secretaries proactively manage breast cancer screening needs.

A Stitch in Time: Strategic Self-Control in High School and College Students.

PubMed

Duckworth, Angela L; White, Rachel E; Matteucci, Alyssa J; Shearer, Annie; Gross, James J

2016-04-01

A growing body of research indicates that self-control is critical to academic success. Surprisingly little is known, however, about the diverse strategies students use to implement self-control or how well these strategies work. To address these issues, we conducted a naturalistic investigation of self-control strategies (Study 1) and two field experiments (Studies 2 and 3). In Study 1, high school students described the strategies they use to manage interpersonal conflicts, get academic work done, eat healthfully, and manage other everyday self-control challenges. The majority of strategies in these self-nominated incidents as well as in three hypothetical academic scenarios (e.g., studying instead of texting friends) were reliably classified using the process model of self-control. As predicted by the process model, students rated strategies deployed early in the impulse-generation process (situation selection, situation modification) as being dramatically more effective than strategies deployed later (attentional deployment, cognitive change, response modulation). In Study 2, high school students randomly assigned to implement situation modification were more likely to meet their academic goals during the following week than students assigned either to implement response modulation or no strategy at all. In Study 3, college students randomly assigned to implement situation modification were also more successful in meeting their academic goals, and this effect was partially mediated by decreased feelings of temptation throughout the week. Collectively, these findings suggest that students might benefit from learning to initiate self-control when their impulses are still nascent.

A Stitch in Time: Strategic Self-Control in High School and College Students

PubMed Central

Duckworth, Angela L.; White, Rachel E.; Matteucci, Alyssa J.; Shearer, Annie; Gross, James J.

2015-01-01

A growing body of research indicates that self-control is critical to academic success. Surprisingly little is known, however, about the diverse strategies students use to implement self-control or how well these strategies work. To address these issues, we conducted a naturalistic investigation of self-control strategies (Study 1) and two field experiments (Studies 2 and 3). In Study 1, high school students described the strategies they use to manage interpersonal conflicts, get academic work done, eat healthfully, and manage other everyday self-control challenges. The majority of strategies in these self-nominated incidents as well as in three hypothetical academic scenarios (e.g., studying instead of texting friends) were reliably classified using the process model of self-control. As predicted by the process model, students rated strategies deployed early in the impulse-generation process (situation selection, situation modification) as being dramatically more effective than strategies deployed later (attentional deployment, cognitive change, response modulation). In Study 2, high school students randomly assigned to implement situation modification were more likely to meet their academic goals during the following week than students assigned either to implement response modulation or no strategy at all. In Study 3, college students randomly assigned to implement situation modification were also more successful in meeting their academic goals, and this effect was partially mediated by decreased feelings of temptation throughout the week. Collectively, these findings suggest that students might benefit from learning to initiate self-control when their impulses are still nascent. PMID:27158155

Prolonged breast-feeding and mortality up to two years post-partum among HIV-positive women in Zambia

PubMed Central

Kuhn, Louise; Kasonde, Prisca; Sinkala, Moses; Kankasa, Chipepo; Semrau, Katherine; Vwalika, Cheswa; Tsai, Wei-Yann; Aldrovandi, Grace M.; Thea, Donald M.

2005-01-01

Background A previously reported association between prolonged lactation and maternal mortality has generated concern that breast-feeding may be detrimental for HIV-positive women. Methods As part of a trial conducted in Lusaka, Zambia, 653 HIV-positive women were randomly assigned either to a counseling program that encouraged abrupt cessation of breast-feeding at 4 months (group A) or to a program that encouraged prolonged breast-feeding for the duration of the woman’s own informed choice (group B). We examined whether mortality up to 2 years post-partum increased with breast-feeding for a longer duration. Results There was no difference in mortality 12 months after delivery between 326 HIV-positive women randomly assigned to short breast-feeding [group A: 4.93%; 95% confidence interval (CI), 2.42–7.46] versus 327 women assigned to long breast-feeding (group B: 4.89%; 95% CI, 2.38–7.40). Analysis based on actual practice, rather than random assignment, also demonstrated no increased mortality due to breast-feeding. Conclusions Although HIV-related mortality was high in this cohort of untreated HIV-positive women, prolonged lactation was not associated with increased mortality. PMID:16184038

Randomized controlled trial of tranexamic acid among parturients at increased risk for postpartum hemorrhage undergoing cesarean delivery.

PubMed

Sujata, Nambiath; Tobin, Raj; Kaur, Ranjeet; Aneja, Anjila; Khanna, Mona; Hanjoora, Vijay M

2016-06-01

To assess the effects of tranexamic acid among patients undergoing cesarean delivery who were at high risk of postpartum hemorrhage. Between August 1, 2012, and April 30, 2013, a randomized controlled trial was performed at a tertiary care center in India. Women undergoing an elective or emergency cesarean delivery who were at high risk for postpartum hemorrhage were enrolled. They were randomly assigned using sealed, opaque envelopes to receive 10mg/kg tranexamic acid or normal saline 10min before skin incision. Anesthesiologists were not masked to group assignment, but patients and obstetricians were. The primary outcome was need for additional uterotonic drugs within 24h after delivery. Analyses were by intention to treat. Thirty patients were assigned to each group. Additional uterotonic drugs were required in 7 (23%) patients assigned to tranexamic acid and 25 (83%) patients in the control group (P<0.001). Intravenous tranexamic acid, administered before skin incision, significantly reduced the requirement for additional uterotonics among women at increased risk for postpartum hemorrhage. Clinical Trials Registry India: CTRI/2015/05/005752. Copyright © 2016 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Vaccination With Patient-Specific Tumor-Derived Antigen in First Remission Improves Disease-Free Survival in Follicular Lymphoma

PubMed Central

Schuster, Stephen J.; Neelapu, Sattva S.; Gause, Barry L.; Janik, John E.; Muggia, Franco M.; Gockerman, Jon P.; Winter, Jane N.; Flowers, Christopher R.; Nikcevich, Daniel A.; Sotomayor, Eduardo M.; McGaughey, Dean S.; Jaffe, Elaine S.; Chong, Elise A.; Reynolds, Craig W.; Berry, Donald A.; Santos, Carlos F.; Popa, Mihaela A.; McCord, Amy M.; Kwak, Larry W.

2011-01-01

Purpose Vaccination with hybridoma-derived autologous tumor immunoglobulin (Ig) idiotype (Id) conjugated to keyhole limpet hemocyanin (KLH) and administered with granulocyte-monocyte colony-stimulating factor (GM-CSF) induces follicular lymphoma (FL) –specific immune responses. To determine the clinical benefit of this vaccine, we conducted a double-blind multicenter controlled phase III trial. Patients and Methods Treatment-naive patients with advanced stage FL achieving complete response (CR) or CR unconfirmed (CRu) after chemotherapy were randomly assigned two to one to receive either Id vaccine (Id-KLH + GM-CSF) or control (KLH + GM-CSF). Primary efficacy end points were disease-free survival (DFS) for all randomly assigned patients and DFS for randomly assigned patients receiving at least one dose of Id vaccine or control. Results Of 234 patients enrolled, 177 (81%) achieved CR/CRu after chemotherapy and were randomly assigned. For 177 randomly assigned patients, including 60 patients not vaccinated because of relapse (n = 55) or other reasons (n = 5), median DFS between Id-vaccine and control arms was 23.0 versus 20.6 months, respectively (hazard ratio [HR], 0.81; 95% CI, 0.56 to 1.16; P = .256). For 117 patients who received Id vaccine (n = 76) or control (n = 41), median DFS after randomization was 44.2 months for Id-vaccine arm versus 30.6 months for control arm (HR, 0.62; 95% CI, 0.39 to 0.99; P = .047) at median follow-up of 56.6 months (range, 12.6 to 89.3 months). In an unplanned subgroup analysis, median DFS was significantly prolonged for patients receiving IgM-Id (52.9 v 28.7 months; P = .001) but not IgG-Id vaccine (35.1 v 32.4 months; P = .807) compared with isotype-matched control-treated patients. Conclusion Vaccination with patient-specific hybridoma-derived Id vaccine after chemotherapy-induced CR/CRu may prolong DFS in patients with FL. Vaccine isotype may affect clinical outcome and explain differing results between this and other controlled Id-vaccine trials. PMID:21632504

Improving the evidence base in palliative care to inform practice and policy: thinking outside the box.

PubMed

Aoun, Samar M; Nekolaichuk, Cheryl

2014-12-01

The adoption of evidence-based hierarchies and research methods from other disciplines may not completely translate to complex palliative care settings. The heterogeneity of the palliative care population, complexity of clinical presentations, and fluctuating health states present significant research challenges. The aim of this narrative review was to explore the debate about the use of current evidence-based approaches for conducting research, such as randomized controlled trials and other study designs, in palliative care, and more specifically to (1) describe key myths about palliative care research; (2) highlight substantive challenges of conducting palliative care research, using case illustrations; and (3) propose specific strategies to address some of these challenges. Myths about research in palliative care revolve around evidence hierarchies, sample heterogeneity, random assignment, participant burden, and measurement issues. Challenges arise because of the complex physical, psychological, existential, and spiritual problems faced by patients, families, and service providers. These challenges can be organized according to six general domains: patient, system/organization, context/setting, study design, research team, and ethics. A number of approaches for dealing with challenges in conducting research fall into five separate domains: study design, sampling, conceptual, statistical, and measures and outcomes. Although randomized controlled trials have their place whenever possible, alternative designs may offer more feasible research protocols that can be successfully implemented in palliative care. Therefore, this article highlights "outside the box" approaches that would benefit both clinicians and researchers in the palliative care field. Ultimately, the selection of research designs is dependent on a clearly articulated research question, which drives the research process. Copyright © 2014 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Random Versus Blocked Practice to Enhance Mental Representation in Golf Putting.

PubMed

Fazeli, Davoud; Taheri, HamidReza; Saberi Kakhki, Alireza

2017-06-01

The purpose of this study was to investigate changes in mental representation from either random or blocked practice when engaged in golf putting. Thirty participants were randomly assigned to random practice, blocked practice, and no-practice groups. First, we measured novice golfers' initial mental representation levels and required them to perform 18 putting trials as a pre-test. We then asked random and blocked groups to practice in accordance with their group assignment for six consecutive days (10 blocks each day, 18 trials each). A week after the last practice session, we re-measured all participants' final mental representation levels and required them to perform 18 putting trials to evaluate learning retention through practice. While those engaged in the random practice method putted more poorly during acquisition (i.e., practice) than those in blocked practice, the random practice group experienced more accurate retention during the final putting trials, and they showed a more structured mental representation than those in blocked practice, one that was more similar to that of skilled golfers. These results support the acquisition of a rich mental representation through random versus blocked practice.

Hyperforin plasma level as a marker of treatment adherence in the National Institutes of Health Hypericum Depression Trial.

PubMed

Vitiello, Benedetto; Shader, Richard I; Parker, Corette B; Ritz, Louise; Harlan, William; Greenblatt, David J; Gadde, Kishore M; Krishnan, K Ranga R; Davidson, Jonathan R T

2005-06-01

A previously reported clinical trial of Hypericum perforatum (St John's wort) in depression did not demonstrate efficacy. We assessed treatment adherence by measuring plasma hyperforin and evaluated the possible impact of adherence on study results. Outpatients with major depression (N = 340) were randomized to an 8-week trial of H. perforatum (900-1500 mg/d), sertraline (50-100 mg/d) as active comparator, or placebo. Plasma was available from 292 patients (86% of randomized). Samples from the placebo and H. perforatum groups were assayed for hyperforin, and samples from the sertraline group for sertraline/N-desmethyl-sertraline. Of the 104 patients randomized to placebo, 18 (17%) had detectable plasma hyperforin. Of the 97 patients randomized to H. perforatum, 17 (17%) had no detectable plasma hyperforin. All the assayed sertraline patients (N = 91) had plasma sertraline/N-desmethyl-sertraline. The clinical trial conclusions remained unchanged when only patients with plasma assay consistent with random assignment were included in the analyses. One of every 6 patients assigned to placebo had plasma hyperforin, and 1 of every 6 patients assigned to H. perforatum had no detectable plasma hyperforin. The finding underscores the difficulty of enforcing treatment adherence in clinical trials of preparations that are readily available in the community.

Comparison of a gratitude-based and cognitive restructuring intervention for body dissatisfaction and dysfunctional eating behavior in college women.

PubMed

Wolfe, Wendy L; Patterson, Kaitlyn

2017-01-01

Researchers have investigated the efficacy of a gratitude intervention for decreasing body dissatisfaction (BD) in an internet treatment-seeking sample and demonstrated it worked equally well to decrease BD as cognitive restructuring. We extend this research by testing the efficacy of a gratitude intervention on BD, along with common sequelae of BD: dysfunctional eating, negative mood, and depressive symptoms. Females were randomly assigned to Gratitude, Cognitive Restructuring, or Control conditions. Pre- to post-intervention period comparisons found the gratitude intervention to perform better than the other conditions at increasing body esteem, decreasing BD, reducing dysfunctional eating, and reducing depressive symptoms.

Estimating intervention effects of prevention programs: Accounting for noncompliance

PubMed Central

Stuart, Elizabeth A.; Perry, Deborah F.; Le, Huynh-Nhu; Ialongo, Nicholas S.

2010-01-01

Individuals not fully complying with their assigned treatments is a common problem encountered in randomized evaluations of behavioral interventions. Treatment group members rarely attend all sessions or do all “required” activities; control group members sometimes find ways to participate in aspects of the intervention. As a result, there is often interest in estimating both the effect of being assigned to participate in the intervention, as well as the impact of actually participating and doing all of the required activities. Methods known broadly as “complier average causal effects” (CACE) or “instrumental variables” (IV) methods have been developed to estimate this latter effect, but they are more commonly applied in medical and treatment research. Since the use of these statistical techniques in prevention trials has been less widespread, many prevention scientists may not be familiar with the underlying assumptions and limitations of CACE and IV approaches. This paper provides an introduction to these methods, described in the context of randomized controlled trials of two preventive interventions: one for perinatal depression among at-risk women and the other for aggressive disruptive behavior in children. Through these case studies, the underlying assumptions and limitations of these methods are highlighted. PMID:18843535

Addressing unmet need for HIV testing in emergency care settings: a role for computer-facilitated rapid HIV testing?

PubMed

Kurth, Ann E; Severynen, Anneleen; Spielberg, Freya

2013-08-01

HIV testing in emergency departments (EDs) remains underutilized. The authors evaluated a computer tool to facilitate rapid HIV testing in an urban ED. Randomly assigned nonacute adult ED patients were randomly assigned to a computer tool (CARE) and rapid HIV testing before a standard visit (n = 258) or to a standard visit (n = 259) with chart access. The authors assessed intervention acceptability and compared noted HIV risks. Participants were 56% nonWhite and 58% male; median age was 37 years. In the CARE arm, nearly all (251/258) of the patients completed the session and received HIV results; four declined to consent to the test. HIV risks were reported by 54% of users; one participant was confirmed HIV-positive, and two were confirmed false-positive (seroprevalence 0.4%, 95% CI [0.01, 2.2]). Half (55%) of the patients preferred computerized rather than face-to-face counseling for future HIV testing. In the standard arm, one HIV test and two referrals for testing occurred. Computer-facilitated HIV testing appears acceptable to ED patients. Future research should assess cost-effectiveness compared with staff-delivered approaches.

Effectiveness of an Extended Yoga Treatment for Women with Chronic Posttraumatic Stress Disorder.

PubMed

Price, Maggi; Spinazzola, Joseph; Musicaro, Regina; Turner, Jennifer; Suvak, Michael; Emerson, David; van der Kolk, Bessel

2017-04-01

Yoga has been found to be an effective posttraumatic stress disorder (PTSD) treatment for a variety of trauma survivors, including females with chronic PTSD. Aim/Purpose: The current study builds on extant research by examining an extended trauma-sensitive yoga treatment for women with chronic PTSD. The study sought to optimize the results of a treatment protocol examined in a recent randomized controlled trial with a shorter duration and without assignment or monitoring of home practice. The authors examined a 20-week trauma-sensitive yoga treatment in a non-randomized single-group treatment feasibility study for women with chronic treatment-resistant PTSD (N = 9). The authors examined PTSD and dissociation symptom reduction over several assessment periods. The results indicate that participants experienced significant reductions in PTSD and dissociative symptomatology above and beyond similar treatments of a shorter duration. The findings suggest that more intensive trauma-sensitive yoga treatment characterized by longer duration and intentional assignment and monitoring of home practice may be more advantageous for individuals with severe and chronic PTSD. The implications of the findings for the potentially more substantial role of yoga as an intervention for a subset of adults with chronic treatment-resistant PTSD are discussed.

Advisor-Teller Money Manager (ATM) therapy for substance use disorders.

PubMed

Rosen, Marc I; Rounsaville, Bruce J; Ablondi, Karen; Black, Anne C; Rosenheck, Robert A

2010-07-01

Patients with concomitant psychiatric and substance use disorders are commonly assigned representative payees or case managers to help manage their funds, but money management has not been conceptualized as a theory-based treatment. This randomized clinical trial was conducted to determine the effect of a money management-based therapy, advisor-teller money manager (ATM), on substance abuse or dependence. Ninety patients at a community mental health center who had a history of cocaine or alcohol abuse or dependence were assessed after random assignment to 36 weeks of ATM (N=47) or a control condition in which use of a financial workbook was reviewed (N=43). Patients assigned to ATM were encouraged to deposit their funds into a third-party account, plan weekly expenditures, and negotiate monthly budgets. Substance use calendars and urine toxicology tests were collected every other week for 36 weeks and again 52 weeks after randomization. Patients assigned to ATM had significantly more negative toxicologies for cocaine metabolite over time than patients in the control group, and treating clinicians rated ATM patients as significantly more likely to be abstinent from illicit drugs. Self-reported abstinence from alcohol did not significantly differ between groups. Unexpectedly, patients assigned to ATM were more likely to be assigned a representative payee or a conservator than control participants during the follow-up period (ten of 47 versus two of 43). One patient in ATM assaulted the therapist when his check had not arrived. ATM is an efficacious therapy for the treatment of cocaine abuse or dependence among people with concomitant psychiatric illness but requires protection of patient autonomy and staff safety.

The direct assignment option as a modular design component: an example for the setting of two predefined subgroups.

PubMed

An, Ming-Wen; Lu, Xin; Sargent, Daniel J; Mandrekar, Sumithra J

2015-01-01

A phase II design with an option for direct assignment (stop randomization and assign all patients to experimental treatment based on interim analysis, IA) for a predefined subgroup was previously proposed. Here, we illustrate the modularity of the direct assignment option by applying it to the setting of two predefined subgroups and testing for separate subgroup main effects. We power the 2-subgroup direct assignment option design with 1 IA (DAD-1) to test for separate subgroup main effects, with assessment of power to detect an interaction in a post-hoc test. Simulations assessed the statistical properties of this design compared to the 2-subgroup balanced randomized design with 1 IA, BRD-1. Different response rates for treatment/control in subgroup 1 (0.4/0.2) and in subgroup 2 (0.1/0.2, 0.4/0.2) were considered. The 2-subgroup DAD-1 preserves power and type I error rate compared to the 2-subgroup BRD-1, while exhibiting reasonable power in a post-hoc test for interaction. The direct assignment option is a flexible design component that can be incorporated into broader design frameworks, while maintaining desirable statistical properties, clinical appeal, and logistical simplicity.

Decision support for hospital bed management using adaptable individual length of stay estimations and shared resources

PubMed Central

2013-01-01

Background Elective patient admission and assignment planning is an important task of the strategic and operational management of a hospital and early on became a central topic of clinical operations research. The management of hospital beds is an important subtask. Various approaches have been proposed, involving the computation of efficient assignments with regard to the patients’ condition, the necessity of the treatment, and the patients’ preferences. However, these approaches are mostly based on static, unadaptable estimates of the length of stay and, thus, do not take into account the uncertainty of the patient’s recovery. Furthermore, the effect of aggregated bed capacities have not been investigated in this context. Computer supported bed management, combining an adaptable length of stay estimation with the treatment of shared resources (aggregated bed capacities) has not yet been sufficiently investigated. The aim of our work is: 1) to define a cost function for patient admission taking into account adaptable length of stay estimations and aggregated resources, 2) to define a mathematical program formally modeling the assignment problem and an architecture for decision support, 3) to investigate four algorithmic methodologies addressing the assignment problem and one base-line approach, and 4) to evaluate these methodologies w.r.t. cost outcome, performance, and dismissal ratio. Methods The expected free ward capacity is calculated based on individual length of stay estimates, introducing Bernoulli distributed random variables for the ward occupation states and approximating the probability densities. The assignment problem is represented as a binary integer program. Four strategies for solving the problem are applied and compared: an exact approach, using the mixed integer programming solver SCIP; and three heuristic strategies, namely the longest expected processing time, the shortest expected processing time, and random choice. A baseline approach serves to compare these optimization strategies with a simple model of the status quo. All the approaches are evaluated by a realistic discrete event simulation: the outcomes are the ratio of successful assignments and dismissals, the computation time, and the model’s cost factors. Results A discrete event simulation of 226,000 cases shows a reduction of the dismissal rate compared to the baseline by more than 30 percentage points (from a mean dismissal ratio of 74.7% to 40.06% comparing the status quo with the optimization strategies). Each of the optimization strategies leads to an improved assignment. The exact approach has only a marginal advantage over the heuristic strategies in the model’s cost factors (≤3%). Moreover,this marginal advantage was only achieved at the price of a computational time fifty times that of the heuristic models (an average computing time of 141 s using the exact method, vs. 2.6 s for the heuristic strategy). Conclusions In terms of its performance and the quality of its solution, the heuristic strategy RAND is the preferred method for bed assignment in the case of shared resources. Future research is needed to investigate whether an equally marked improvement can be achieved in a large scale clinical application study, ideally one comprising all the departments involved in admission and assignment planning. PMID:23289448

Decision support for hospital bed management using adaptable individual length of stay estimations and shared resources.

PubMed

Schmidt, Robert; Geisler, Sandra; Spreckelsen, Cord

2013-01-07

Elective patient admission and assignment planning is an important task of the strategic and operational management of a hospital and early on became a central topic of clinical operations research. The management of hospital beds is an important subtask. Various approaches have been proposed, involving the computation of efficient assignments with regard to the patients' condition, the necessity of the treatment, and the patients' preferences. However, these approaches are mostly based on static, unadaptable estimates of the length of stay and, thus, do not take into account the uncertainty of the patient's recovery. Furthermore, the effect of aggregated bed capacities have not been investigated in this context. Computer supported bed management, combining an adaptable length of stay estimation with the treatment of shared resources (aggregated bed capacities) has not yet been sufficiently investigated. The aim of our work is: 1) to define a cost function for patient admission taking into account adaptable length of stay estimations and aggregated resources, 2) to define a mathematical program formally modeling the assignment problem and an architecture for decision support, 3) to investigate four algorithmic methodologies addressing the assignment problem and one base-line approach, and 4) to evaluate these methodologies w.r.t. cost outcome, performance, and dismissal ratio. The expected free ward capacity is calculated based on individual length of stay estimates, introducing Bernoulli distributed random variables for the ward occupation states and approximating the probability densities. The assignment problem is represented as a binary integer program. Four strategies for solving the problem are applied and compared: an exact approach, using the mixed integer programming solver SCIP; and three heuristic strategies, namely the longest expected processing time, the shortest expected processing time, and random choice. A baseline approach serves to compare these optimization strategies with a simple model of the status quo. All the approaches are evaluated by a realistic discrete event simulation: the outcomes are the ratio of successful assignments and dismissals, the computation time, and the model's cost factors. A discrete event simulation of 226,000 cases shows a reduction of the dismissal rate compared to the baseline by more than 30 percentage points (from a mean dismissal ratio of 74.7% to 40.06% comparing the status quo with the optimization strategies). Each of the optimization strategies leads to an improved assignment. The exact approach has only a marginal advantage over the heuristic strategies in the model's cost factors (≤3%). Moreover,this marginal advantage was only achieved at the price of a computational time fifty times that of the heuristic models (an average computing time of 141 s using the exact method, vs. 2.6 s for the heuristic strategy). In terms of its performance and the quality of its solution, the heuristic strategy RAND is the preferred method for bed assignment in the case of shared resources. Future research is needed to investigate whether an equally marked improvement can be achieved in a large scale clinical application study, ideally one comprising all the departments involved in admission and assignment planning.

The Impact of Legalizing and Regulating Weed: Issues with Study Design and Emerging Findings in the USA.

PubMed

Hunt, Priscillia E; Miles, Jeremy

2017-01-01

Evaluations of the impact of medical and recreational marijuana laws rely on quasi- or natural experiments in which researchers exploit changes in the law and attempt to determine the impact of these changes on outcomes. This chapter reviews three key issues of causal inference in observational studies with respect to estimating of impact of medical or recreational laws on marijuana use-intervention definition, outcome measurement, and random assignment of study participants. We show that studies tend to use the same statistical approach (differences-in-differences) and yet find differential impacts of medical marijuana laws on adult use in particular. We demonstrate that these seemingly conflicting findings may be due to different years of analysis, ages of the study sample in each year, and assignment of jurisdictions to the control group versus treatment group.

Random Assignment: Practical Considerations from Field Experiments.

ERIC Educational Resources Information Center

Dunford, Franklyn W.

1990-01-01

Seven qualitative issues associated with randomization that have the potential to weaken or destroy otherwise sound experimental designs are reviewed and illustrated via actual field experiments. Issue areas include ethics and legality, liability risks, manipulation of randomized outcomes, hidden bias, design intrusiveness, case flow, and…

Effects of music therapy on self- and experienced stigma in patients on an acute care psychiatric unit: a randomized three group effectiveness study.

PubMed

Silverman, Michael J

2013-10-01

Stigma is a major social barrier that can restrict access to and willingness to seek psychiatric care. Psychiatric consumers may use secrecy and withdrawal in an attempt to cope with stigma. The purpose of this study was to determine the effects of music therapy on self- and experienced stigma in acute care psychiatric inpatients using a randomized design with wait-list control. Participants (N=83) were randomly assigned by cluster to one of three single-session group-based conditions: music therapy, education, or wait-list control. Participants in the music therapy and education conditions completed only posttests while participants in the wait-list control condition completed only pretests. The music therapy condition was a group songwriting intervention wherein participants composed lyrics for "the stigma blues." Results indicated significant differences in measures of discrimination (experienced stigma), disclosure (self-stigma), and total stigma between participants in the music therapy condition and participants in the wait-list control condition. From the results of this randomized controlled investigation, music therapy may be an engaging and effective psychosocial technique to treat stigma. Limitations, suggestions for future research, and implications for clinical practice and psychiatric music therapy research are provided. © 2013.

Late outcomes of a randomized trial of high-frequency oscillation in neonates.

PubMed

Zivanovic, Sanja; Peacock, Janet; Alcazar-Paris, Mireia; Lo, Jessica W; Lunt, Alan; Marlow, Neil; Calvert, Sandy; Greenough, Anne

2014-03-20

Results from an observational study involving neonates suggested that high-frequency oscillatory ventilation (HFOV), as compared with conventional ventilation, was associated with superior small-airway function at follow-up. Data from randomized trials are needed to confirm this finding. We studied 319 adolescents who had been born before 29 weeks of gestation and had been enrolled in a multicenter, randomized trial that compared HFOV with conventional ventilation immediately after birth. The trial involved 797 neonates, of whom 592 survived to hospital discharge. We compared follow-up data from adolescents who had been randomly assigned to HFOV with follow-up data from those who had been randomly assigned to conventional ventilation, with respect to lung function and respiratory health, health-related quality of life, and functional status, as assessed with the use of questionnaires completed when the participants were 11 to 14 years of age. The primary outcome was forced expiratory flow at 75% of the expired vital capacity (FEF75). The HFOV group had superior results on a test of small-airway function (z score for FEF75, -0.97 with HFOV vs. -1.19 with conventional therapy; adjusted difference, 0.23 [95% confidence interval, 0.02 to 0.45]). There were significant differences in favor of HFOV in several other measures of respiratory function, including forced expiratory volume in 1 second, forced vital capacity, peak expiratory flow, diffusing capacity, and impulse-oscillometric findings. As compared with the conventional-therapy group, the HFOV group had significantly higher ratings from teachers in three of eight school subjects assessed, but there were no other significant differences in functional outcomes. In a randomized trial involving children who had been born extremely prematurely, those who had undergone HFOV, as compared with those who had received conventional ventilation, had superior lung function at 11 to 14 years of age, with no evidence of poorer functional outcomes. (Funded by the National Institute for Health Research Health Technology Assessment Programme and others.).

Emergency department-initiated palliative care for advanced cancer patients: protocol for a pilot randomized controlled trial.

PubMed

Kandarian, Brandon; Morrison, R Sean; Richardson, Lynne D; Ortiz, Joanna; Grudzen, Corita R

2014-06-25

For patients with advanced cancer, visits to the emergency department (ED) are common. Such patients present to the ED with a specific profile of palliative care needs, including burdensome symptoms such as pain, dyspnea, or vomiting that cannot be controlled in other settings and a lack of well-defined goals of care. The goals of this study are: i) to test the feasibility of recruiting, enrolling, and randomizing patients with serious illness in the ED; and ii) to evaluate the impact of ED-initiated palliative care on health care utilization, quality of life, and survival. This is a protocol for a single center parallel, two-arm randomized controlled trial in ED patients with metastatic solid tumors comparing ED-initiated palliative care referral to a control group receiving usual care. We plan to enroll 125 to 150 ED-advanced cancer patients at Mount Sinai Hospital in New York, USA, who meet the following criteria: i) pass a brief cognitive screen; ii) speak fluent English or Spanish; and iii) have never been seen by palliative care. We will use balanced block randomization in groups of 50 to assign patients to the intervention or control group after completion of a baseline questionnaire. All research staff performing assessment or analysis will be blinded to patient assignment. We will measure the impact of the palliative care intervention on the following outcomes: i) timing and rate of palliative care consultation; ii) quality of life and depression at 12 weeks, measured using the FACT-G and PHQ-9; iii) health care utilization; and iv) length of survival. The primary analysis will be based on intention-to-treat. This pilot randomized controlled trial will test the feasibility of recruiting, enrolling, and randomizing patients with advanced cancer in the ED, and provide a preliminary estimate of the impact of palliative care referral on health care utilization, quality of life, and survival. Clinical Trials.gov identifier: NCT01358110 (Entered 5/19/2011).

Peer Influence, Genetic Propensity, and Binge Drinking: A Natural Experiment and a Replication.

PubMed

Guo, Guang; Li, Yi; Wang, Hongyu; Cai, Tianji; Duncan, Greg J

2015-11-01

The authors draw data from the College Roommate Study (ROOM) and the National Longitudinal Study of Adolescent Health to investigate gene-environment interaction effects on youth binge drinking. In ROOM, the environmental influence was measured by the precollege drinking behavior of randomly assigned roommates. Random assignment safeguards against friend selection and removes the threat of gene-environment correlation that makes gene-environment interaction effects difficult to interpret. On average, being randomly assigned a drinking peer as opposed to a nondrinking peer increased college binge drinking by 0.5-1.0 episodes per month, or 20%-40% the average amount of binge drinking. However, this peer influence was found only among youths with a medium level of genetic propensity for alcohol use; those with either a low or high genetic propensity were not influenced by peer drinking. A replication of the findings is provided in data drawn from Add Health. The study shows that gene-environment interaction analysis can uncover social-contextual effects likely to be missed by traditional sociological approaches.

Primary Prevention of Cardiovascular Disease with a Mediterranean Diet Supplemented with Extra-Virgin Olive Oil or Nuts.

PubMed

Estruch, Ramón; Ros, Emilio; Salas-Salvadó, Jordi; Covas, Maria-Isabel; Corella, Dolores; Arós, Fernando; Gómez-Gracia, Enrique; Ruiz-Gutiérrez, Valentina; Fiol, Miquel; Lapetra, José; Lamuela-Raventos, Rosa M; Serra-Majem, Lluís; Pintó, Xavier; Basora, Josep; Muñoz, Miguel A; Sorlí, José V; Martínez, J Alfredo; Fitó, Montserrat; Gea, Alfredo; Hernán, Miguel A; Martínez-González, Miguel A

2018-06-21

Observational cohort studies and a secondary prevention trial have shown inverse associations between adherence to the Mediterranean diet and cardiovascular risk. In a multicenter trial in Spain, we assigned 7447 participants (55 to 80 years of age, 57% women) who were at high cardiovascular risk, but with no cardiovascular disease at enrollment, to one of three diets: a Mediterranean diet supplemented with extra-virgin olive oil, a Mediterranean diet supplemented with mixed nuts, or a control diet (advice to reduce dietary fat). Participants received quarterly educational sessions and, depending on group assignment, free provision of extra-virgin olive oil, mixed nuts, or small nonfood gifts. The primary end point was a major cardiovascular event (myocardial infarction, stroke, or death from cardiovascular causes). After a median follow-up of 4.8 years, the trial was stopped on the basis of a prespecified interim analysis. In 2013, we reported the results for the primary end point in the Journal. We subsequently identified protocol deviations, including enrollment of household members without randomization, assignment to a study group without randomization of some participants at 1 of 11 study sites, and apparent inconsistent use of randomization tables at another site. We have withdrawn our previously published report and now report revised effect estimates based on analyses that do not rely exclusively on the assumption that all the participants were randomly assigned. A primary end-point event occurred in 288 participants; there were 96 events in the group assigned to a Mediterranean diet with extra-virgin olive oil (3.8%), 83 in the group assigned to a Mediterranean diet with nuts (3.4%), and 109 in the control group (4.4%). In the intention-to-treat analysis including all the participants and adjusting for baseline characteristics and propensity scores, the hazard ratio was 0.69 (95% confidence interval [CI], 0.53 to 0.91) for a Mediterranean diet with extra-virgin olive oil and 0.72 (95% CI, 0.54 to 0.95) for a Mediterranean diet with nuts, as compared with the control diet. Results were similar after the omission of 1588 participants whose study-group assignments were known or suspected to have departed from the protocol. In this study involving persons at high cardiovascular risk, the incidence of major cardiovascular events was lower among those assigned to a Mediterranean diet supplemented with extra-virgin olive oil or nuts than among those assigned to a reduced-fat diet. (Funded by Instituto de Salud Carlos III, Spanish Ministry of Health, and others; Current Controlled Trials number, ISRCTN35739639 .).

Attention shaping as a means to improve emotion perception deficits in outpatients with schizophrenia and impaired controls.

PubMed

Combs, Dennis R; Chapman, Dustin; Waguspack, Jace; Basso, Michael R; Penn, David L

2011-04-01

Deficits in emotion perception are common in people with schizophrenia and current research has focused on improving these deficits. In our previous research, we demonstrated that directing attention to salient facial features via attention shaping can improve these deficits among inpatients. In this study, we examined the efficacy of an enhanced attention shaping program that contains 192 emotional expressions from which 25 are randomly presented for training. We extended our previous work by using repeated administrations of the shaping intervention and testing its effect in outpatients with schizophrenia and impaired controls. Fifteen participants with schizophrenia and fourteen college student controls with emotion perception deficits were randomly assigned to 1, 3 or 5 sessions of attention shaping. Participants completed 2 outcome measures of emotion perception, the FEIT and BLERT, not presented during the training, and underwent eye tracking at pre and post-tests. All conditions and groups improved, but the largest improvements on the BLERT and FEIT were found for persons assigned to the 5 session condition. Performance on the shaping program was positively correlated with the two outcome measures of emotion perception. There was less support for changes in visual scanning of faces as there was a relative reduction in total scanning time from pre-test to post-test. Results are interpreted in terms of the efficacy of attention shaping as a means to improve emotion perception deficits. Copyright © 2010 Elsevier B.V. All rights reserved.

Effect of Allowing Choice of Diet on Weight Loss: A Randomized Trial.

PubMed

Yancy, William S; Mayer, Stephanie B; Coffman, Cynthia J; Smith, Valerie A; Kolotkin, Ronette L; Geiselman, Paula J; McVay, Megan A; Oddone, Eugene Z; Voils, Corrine I

2015-06-16

Choosing a diet rather than being prescribed one could improve weight loss. To examine whether offering choice of diet improves weight loss. Double-randomized preference trial of choice between 2 diets (choice) versus random assignment to a diet (comparator) over 48 weeks. (ClinicalTrials.gov: NCT01152359). Outpatient clinic at a Veterans Affairs medical center. Outpatients with a body mass index of at least 30 kg/m2. Choice participants received information about their food preferences and 2 diet options (low-carbohydrate diet [LCD] or low-fat diet [LFD]) before choosing and were allowed to switch diets at 12 weeks. Comparator participants were randomly assigned to 1 diet for 48 weeks. Both groups received group and telephone counseling for 48 weeks. The primary outcome was weight at 48 weeks. Of 105 choice participants, 61 (58%) chose the LCD and 44 (42%) chose the LFD; 5 (3 on the LCD and 2 on the LFD) switched diets at 12 weeks, and 87 (83%) completed measurements at 48 weeks. Of 102 comparator participants, 53 (52%) were randomly assigned to the LCD and 49 (48%) were assigned to the LFD; 88 (86%) completed measurements. At 48 weeks, estimated mean weight loss was 5.7 kg (95% CI, 4.3 to 7.0 kg) in the choice group and 6.7 kg (CI, 5.4 to 8.0 kg) in the comparator group (mean difference, -1.1 kg [CI, -2.9 to 0.8 kg]; P = 0.26). Secondary outcomes of dietary adherence, physical activity, and weight-related quality of life were similar between groups at 48 weeks. Only 2 diet options were provided. Results from this sample of older veterans might not be generalizable to other populations. Contrary to expectations, the opportunity to choose a diet did not improve weight loss.

Surgical versus Non-Operative Treatment for Lumbar Disc Herniation: Eight-Year Results for the Spine Patient Outcomes Research Trial (SPORT)

PubMed Central

Lurie, Jon D.; Tosteson, Tor D.; Tosteson, Anna N. A.; Zhao, Wenyan; Morgan, Tamara S.; Abdu, William A.; Herkowitz, Harry; Weinstein, James N.

2014-01-01

Study Design Concurrent prospective randomized and observational cohort studies. Objective To assess the 8-year outcomes of surgery vs. non-operative care. Summary of Background Data Although randomized trials have demonstrated small short-term differences in favor of surgery, long-term outcomes comparing surgical to non-operative treatment remain controversial. Methods Surgical candidates with imaging-confirmed lumbar intervertebral disc herniation meeting SPORT eligibility criteria enrolled into prospective randomized (501 participants) and observational cohorts (743 participants) at 13 spine clinics in 11 US states. Interventions were standard open discectomy versus usual non-operative care. Main outcome measures were changes from baseline in the SF-36 Bodily Pain (BP) and Physical Function (PF) scales and the modified Oswestry Disability Index (ODI - AAOS/Modems version) assessed at 6 weeks, 3 and 6 months, and annually thereafter. Results Advantages were seen for surgery in intent-to-treat analyses for the randomized cohort for all primary and secondary outcomes other than work status; however, with extensive non-adherence to treatment assignment (49% patients assigned to non-operative therapy receiving surgery versus 60% of patients assigned to surgery) these observed effects were relatively small and not statistically significant for primary outcomes (BP, PF, ODI). Importantly, the overall comparison of secondary outcomes was significantly greater with surgery in the intent-to-treat analysis (sciatica bothersomeness [p > 0.005], satisfaction with symptoms [p > 0.013], and self-rated improvement [p > 0.013]) in long-term follow-up. An as-treated analysis showed clinically meaningful surgical treatment effects for primary outcome measures (mean change Surgery vs. Non-operative; treatment effect; 95% CI): BP (45.3 vs. 34.4; 10.9; 7.7 to 14); PF (42.2 vs. 31.5; 10.6; 7.7 to 13.5) and ODI (−36.2 vs. −24.8; −11.2; −13.6 to −9.1). Conclusion Carefully selected patients who underwent surgery for a lumbar disc herniation achieved greater improvement than non-operatively treated patients; there was little to no degradation of outcomes in either group (operative and non-operative) from 4 to 8 years. PMID:24153171

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

PubMed

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

2015-08-01

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

Monetary Incentives Improve Recall of Research Consent Information: A Randomized Pilot Study

PubMed Central

Festinger, David S.; Marlowe, Douglas B.; Croft, Jason R.; Dugosh, Karen L.; Arabia, Patricia L.; Benasutti, Kathleen M.

2011-01-01

Research participants often fail to recall substantial amounts of informed consent information after delays of only a few days. Numerous interventions have proven effective at improving consent recall; however, virtually all have focused on compensating for potential cognitive deficits and have ignored motivational factors. In this pilot study, we randomly assigned 31 drug court clients participating in a clinical research trial to a standard consent procedure or to the same procedure plus incentives for correctly recalling consent information. The incentive group was told they would receive $5 for each of the 15 consent items they could answer correctly 1-week later. At the follow-up, the incentive group recalled a significantly greater percentage of consent information overall than the standard group (65% vs. 42%; p < .01). Similar findings were observed for specific categories of consent information, including study purpose and design, risks and benefits, and human subject protections. Effect sizes were all large (d = 0.89 to 1.25). Findings suggest that motivation plays a key role in recall of consent information and should be considered in the development of future interventions. PMID:19331486

A Randomized Study of a Method for Optimizing Adolescent Assent to Biomedical Research

PubMed Central

Annett, Robert D.; Brody, Janet L.; Scherer, David G.; Turner, Charles W.; Dalen, Jeanne; Raissy, Hengameh

2018-01-01

Purpose Voluntary consent/assent with adolescents invited to participate in research raises challenging problems. No studies to date have attempted to manipulate autonomy in relation to assent/consent processes. This study evaluated the effects of an autonomy-enhanced individualized assent/consent procedure embedded within a randomized pediatric asthma clinical trial. Methods Families were randomly assigned to remain together or separated during a consent/assent process, the latter we characterize as an autonomy-enhanced assent/consent procedure. We hypothesized that separating adolescents from their parents would improve adolescent assent by increasing knowledge and appreciation of the clinical trial and willingness to participate. Results 64 adolescent-parent dyads completed procedures. The together versus separate randomization made no difference in adolescent or parent willingness to participate. However, significant differences were found in both parent and adolescent knowledge of the asthma clinical trial based on the assent/consent procedure and adolescent age. The separate assent/consent procedure improved knowledge of study risks and benefits for older adolescents and their parents but not for the younger youth or their parents. Regardless of the assent/consent process, younger adolescents had lower comprehension of information associated with the study medication and research risks and benefits, but not study procedures or their research rights and privileges. Conclusions The use of an autonomy-enhanced assent/consent procedure for adolescents may improve their and their parent’s informed assent/consent without impacting research participation decisions. Traditional assent/consent procedures may result in a “diffusion of responsibility” effect between parents and older adolescents, specifically in attending to key information associated with study risks and benefits. PMID:28949898

47 CFR 1.994 - Routine terms and conditions.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Random Selection Wireless Radio Services Applications and Proceedings Foreign Ownership of Common Carrier... or spectrum leasing arrangement by assignment or transfer of control provided that the subsidiary or... license or spectrum leasing arrangement by assignment or transfer of control provided that the subsidiary...

47 CFR 1.994 - Routine terms and conditions.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Random Selection Wireless Radio Services Applications and Proceedings Foreign Ownership of Common Carrier... or spectrum leasing arrangement by assignment or transfer of control provided that the subsidiary or... license or spectrum leasing arrangement by assignment or transfer of control provided that the subsidiary...

Improved outcome in pediatric relapsed acute myeloid leukemia: results of a randomized trial on liposomal daunorubicin by the International BFM Study Group.

PubMed

Kaspers, Gertjan J L; Zimmermann, Martin; Reinhardt, Dirk; Gibson, Brenda E S; Tamminga, Rienk Y J; Aleinikova, Olga; Armendariz, Hortensia; Dworzak, Michael; Ha, Shau-Yin; Hasle, Henrik; Hovi, Liisa; Maschan, Alexei; Bertrand, Yves; Leverger, Guy G; Razzouk, Bassem I; Rizzari, Carmelo; Smisek, Petr; Smith, Owen; Stark, Batia; Creutzig, Ursula

2013-02-10

In pediatric relapsed acute myeloid leukemia (AML), optimal reinduction therapy is unknown. Studies suggest that liposomal daunorubicin (DNX; DaunoXome; Galen, Craigavon, United Kingdom) is effective and less cardiotoxic, which is important in this setting. These considerations led to a randomized phase III study by the International Berlin-Frankfurt-Münster Study Group. Patients with relapsed or primary refractory non-French-American-British type M3 AML who were younger than 21 years of age were eligible. Patients were randomly assigned to fludarabine, cytarabine, and granulocyte colony-stimulating factor (FLAG) or to FLAG plus DNX in the first reinduction course. The primary end point was status of the bone marrow (BM) sampled shortly before the second course of chemotherapy (the day 28 BM). Data are presented according to intention-to-treat for all 394 randomly assigned patients (median follow-up, 4.0 years). The complete remission (CR) rate was 64%, and the 4-year probability of survival (pOS) was 38% (SE, 3%). The day 28 BM status (available in 359 patients) was good (≤ 20% leukemic blasts) in 80% of patients randomly assigned to FLAG/DNX and 70% for patients randomly assigned to FLAG (P = .04). Concerning secondary end points, the CR rate was 69% with FLAG/DNX and 59% with FLAG (P = .07), but overall survival was similar. However, core-binding factor (CBF) AML treated with FLAG/DNX resulted in pOS of 82% versus 58% with FLAG (P = .04). Grade 3 to 4 toxicity was essentially similar in both groups. DNX added to FLAG improves early treatment response in pediatric relapsed AML. Overall long-term survival was similar, but CBF-AML showed an improved survival with FLAG/DNX. International collaboration proved feasible and resulted in the best outcome for pediatric relapsed AML reported thus far.

Sequential multiple-assignment randomized trial design of neurobehavioral treatment for patients with metastatic malignant melanoma undergoing high-dose interferon-alpha therapy.

PubMed

Auyeung, S Freda; Long, Qi; Royster, Erica Bruce; Murthy, Smitha; McNutt, Marcia D; Lawson, David; Miller, Andrew; Manatunga, Amita; Musselman, Dominique L

2009-10-01

Interferon-alpha therapy, which is used to treat metastatic malignant melanoma, can cause patients to develop two distinct neurobehavioral symptom complexes: a mood syndrome and a neurovegetative syndrome. Interferon-alpha effects on serotonin metabolism appear to contribute to the mood and anxiety syndrome, while the neurovegetative syndrome appears to be related to interferon-alpha effects on dopamine. Our goal is to propose a design for utilizing a sequential, multiple assignment, randomized trial design for patients with malignant melanoma to test the relative efficacy of drugs that target serotonin versus dopamine metabolism during 4 weeks of intravenous, then 8 weeks of subcutaneous, interferon-alpha therapy. Patients will be offered participation in a double-blinded, randomized, controlled, 14-week trial involving two treatment phases. During the first month of intravenous interferon-alpha therapy, we will test the hypotheses that escitalopram will be more effective in reducing depressed mood, anxiety, and irritability, whereas methylphenidate will be more effective in diminishing interferon-alpha-induced neurovegetative symptoms, such as fatigue and psychomotor slowing. During the next 8 weeks of subcutaneous interferon therapy, participants whose symptoms do not improve significantly will be randomized to the alternate agent alone versus escitalopram and methylphenidate together. We present a prototype for a single-center, sequential, multiple assignment, randomized trial, which seeks to determine the efficacy of sequenced and targeted treatment for the two distinct symptom complexes suffered by patients treated with interferon-alpha. Because we cannot completely control for external factors, a relevant question is whether or not 'short-term' neuropsychiatric interventions can increase the number of interferon-alpha doses tolerated and improve long-term survival. This sequential, multiple assignment, randomized trial proposes a framework for developing optimal treatment strategies; however, additional studies are needed to determine the best strategy for treating or preventing neurobehavioral symptoms induced by the immunotherapy interferon-alpha.

Randomized Trial of Hepatic Artery Embolization for Hepatocellular Carcinoma Using Doxorubicin-Eluting Microspheres Compared With Embolization With Microspheres Alone

PubMed Central

Do, Richard K.; Gonen, Mithat; Covey, Anne M.; Getrajdman, George I.; Sofocleous, Constantinos T.; Jarnagin, William R.; D’Angelica, Michael I.; Allen, Peter J.; Erinjeri, Joseph P.; Brody, Lynn A.; O’Neill, Gerald P.; Johnson, Kristian N.; Garcia, Alessandra R.; Beattie, Christopher; Zhao, Binsheng; Solomon, Stephen B.; Schwartz, Lawrence H.; DeMatteo, Ronald; Abou-Alfa, Ghassan K.

2016-01-01

Purpose Transarterial chemoembolization is accepted therapy for hepatocellular carcinoma (HCC). No randomized trial has demonstrated superiority of chemoembolization compared with embolization, and the role of chemotherapy remains unclear. This randomized trial compares the outcome of embolization using microspheres alone with chemoembolization using doxorubicin-eluting microspheres. Materials and Methods At a single tertiary referral center, patients with HCC were randomly assigned to embolization with microspheres alone (Bead Block [BB]) or loaded with doxorubicin 150 mg (LC Bead [LCB]). Random assignment was stratified by number of embolizations to complete treatment, and assignments were generated by permuted blocks in the institutional database. The primary end point was response according to RECIST 1.0 (Response Evaluation Criteria in Solid Tumors) using multiphase computed tomography 2 to 3 weeks post-treatment and then at quarterly intervals, with the reviewer blinded to treatment allocation. Secondary objectives included safety and tolerability, time to progression, progression-free survival, and overall survival. This trial is currently closed to accrual. Results Between December 2007 and April 2012, 101 patients were randomly assigned: 51 to BB and 50 to LCB. Demographics were comparable: median age, 67 years; 77% male; and 22% Barcelona Clinic Liver Cancer stage A and 78% stage B or C. Adverse events occurred with similar frequency in both groups: BB, 19 of 51 patients (38%); LCB, 20 of 50 patients (40%; P = .48), with no difference in RECIST response: BB, 5.9% versus LCB, 6.0% (difference, −0.1%; 95% CI, −9% to 9%). Median PFS was 6.2 versus 2.8 months (hazard ratio, 1.36; 95% CI, 0.91 to 2.05; P = .11), and overall survival, 19.6 versus 20.8 months (hazard ratio, 1.11; 95% CI, 0.71 to 1.76; P = .64) for BB and LCB, respectively. Conclusion There was no apparent difference between the treatment arms. These results challenge the use of doxorubicin-eluting beads for chemoembolization of HCC. PMID:26834067

A modified generalized extremal optimization algorithm for the quay crane scheduling problem with interference constraints

NASA Astrophysics Data System (ADS)

Guo, Peng; Cheng, Wenming; Wang, Yi

2014-10-01

The quay crane scheduling problem (QCSP) determines the handling sequence of tasks at ship bays by a set of cranes assigned to a container vessel such that the vessel's service time is minimized. A number of heuristics or meta-heuristics have been proposed to obtain the near-optimal solutions to overcome the NP-hardness of the problem. In this article, the idea of generalized extremal optimization (GEO) is adapted to solve the QCSP with respect to various interference constraints. The resulting GEO is termed the modified GEO. A randomized searching method for neighbouring task-to-QC assignments to an incumbent task-to-QC assignment is developed in executing the modified GEO. In addition, a unidirectional search decoding scheme is employed to transform a task-to-QC assignment to an active quay crane schedule. The effectiveness of the developed GEO is tested on a suite of benchmark problems introduced by K.H. Kim and Y.M. Park in 2004 (European Journal of Operational Research, Vol. 156, No. 3). Compared with other well-known existing approaches, the experiment results show that the proposed modified GEO is capable of obtaining the optimal or near-optimal solution in a reasonable time, especially for large-sized problems.

Advisor-Teller Money Manager (ATM) Therapy for Substance Use Disorders

PubMed Central

Rosen, Marc I.; Rounsaville, Bruce J.; Ablondi, Karen; Black, Anne C.; Rosenheck, Robert A.

2011-01-01

Objective Patients with concomitant psychiatric and substance use disorders are commonly assigned representative payees or case managers to help manage their funds, but money management has not been conceptualized as a theory-based treatment. This randomized clinical trial was conducted to determine the effect of a money management–based therapy, advisor-teller money manager (ATM), on substance abuse or dependence. Methods Ninety patients at a community mental health center who had a history of cocaine or alcohol abuse or dependence were assessed after random assignment to 36 weeks of ATM (N=47) or a control condition in which use of a financial workbook was reviewed (N=43). Patients assigned to ATM were encouraged to deposit their funds into a third-party account, plan weekly expenditures, and negotiate monthly budgets. Substance use calendars and urine toxicology tests were collected every other week for 36 weeks and again 52 weeks after randomization. Results Patients assigned to ATM had significantly more negative toxicologies for cocaine metabolite over time than patients in the control group, and treating clinicians rated ATM patients as significantly more likely to be abstinent from illicit drugs. Self-reported abstinence from alcohol did not significantly differ between groups. Unexpectedly, patients assigned to ATM were more likely to be assigned a representative payee or a conservator than control participants during the follow-up period (ten of 47 versus two of 43). One patient in ATM assaulted the therapist when his check had not arrived. Conclusions ATM is an efficacious therapy for the treatment of cocaine abuse or dependence among people with concomitant psychiatric illness but requires protection of patient autonomy and staff safety. PMID:20592006

Exploring the statistical and clinical impact of two interim analyses on the Phase II design with option for direct assignment.

PubMed

An, Ming-Wen; Mandrekar, Sumithra J; Edelman, Martin J; Sargent, Daniel J

2014-07-01

The primary goal of Phase II clinical trials is to understand better a treatment's safety and efficacy to inform a Phase III go/no-go decision. Many Phase II designs have been proposed, incorporating randomization, interim analyses, adaptation, and patient selection. The Phase II design with an option for direct assignment (i.e. stop randomization and assign all patients to the experimental arm based on a single interim analysis (IA) at 50% accrual) was recently proposed [An et al., 2012]. We discuss this design in the context of existing designs, and extend it from a single-IA to a two-IA design. We compared the statistical properties and clinical relevance of the direct assignment design with two IA (DAD-2) versus a balanced randomized design with two IA (BRD-2) and a direct assignment design with one IA (DAD-1), over a range of response rate ratios (2.0-3.0). The DAD-2 has minimal loss in power (<2.2%) and minimal increase in T1ER (<1.6%) compared to a BRD-2. As many as 80% more patients were treated with experimental vs. control in the DAD-2 than with the BRD-2 (experimental vs. control ratio: 1.8 vs. 1.0), and as many as 64% more in the DAD-2 than with the DAD-1 (1.8 vs. 1.1). We illustrate the DAD-2 using a case study in lung cancer. In the spectrum of Phase II designs, the direct assignment design, especially with two IA, provides a middle ground with desirable statistical properties and likely appeal to both clinicians and patients. Copyright © 2014 Elsevier Inc. All rights reserved.

Impact of a Plant-Based Diet and Support on Mitigating Type 2 Diabetes Mellitus in Latinos Living in Medically Underserved Areas.

PubMed

Ramal, Edelweiss; Champlin, Andrea; Bahjri, Khaled

2018-03-01

To determine the impact that a high-fiber, low-fat diet, derived from mostly plant-based sources, when coupled with support has upon self-management of type 2 diabetes mellitus in Latinos from medically underserved areas (MUAs). Experimental randomized controlled community pilot study. Three community clinics in MUAs located within San Bernardino County, California. Thirty-two randomly assigned Latinos with A1 C greater than 6.4: 15 control and 17 experimental. Participants completed a 5-week education program. Researchers provided follow-up support for 17 randomly assigned experimental group participants through focus groups held at participating clinics-1, 3, and 6 months posteducation. Changes in fat and fiber consumption were measured using a modified Dietary Screener for Mexican Americans. Self-management was measured through the Self-Efficacy for Exercise Scale and Diabetes Quality of Life Measure. Baseline characteristics for both groups were analyzed using independent t tests and χ 2 tests. A 2-way repeated-measures analysis of variance was used to analyze biometric data between baseline and 6 months for both groups. Mean A1 C levels decreased from baseline to 6 months for both groups: control, μ 1 = 9.57, μ 2 = 9.49; experimental, μ 1 = 8.53, μ 2 = 7.31. The experimental group demonstrated a statistically significant reduction in mean A1 C levels ( P = .002) when compared to the control group.

Rapid assessment of agents of biological terrorism: defining the differential diagnosis of inhalational anthrax using electronic communication in a practice-based research network.

PubMed

Temte, Jonathan L; Anderson, Anna Lisa

2004-01-01

Early detection of bioterrorism requires assessment of diagnoses assigned to cases of rare diseases with which clinicians have little experience. In this study, we evaluated the process of defining the differential diagnosis for inhalational anthrax using electronic communication within a practice-based research network (PBRN) and compared the results with those obtained from a nationwide random sample of family physicians with a mailed instrument. We distributed survey instruments by e-mail to 55 physician members of the Wisconsin Research Network (WReN), a regional PBRN. The instruments consisted of 3 case vignettes randomly drawn from a set describing 11 patients with inhalational anthrax, 2 with influenza A, and 1 with Legionella pneumonia. Physicians provided their most likely nonanthrax diagnosis, along with their responses to 4 yes-or-no management questions for each case. Physicians who had not responded at 1 week received a second e-mail with the survey instrument. The comparison group consisted of the nationwide sample of physicians who completed mailed survey instruments. Primary outcome measures were response rate, median response time, and frequencies of diagnostic categories assigned to cases of inhalational anthrax. The PBRN response rate compared favorably with that of the national sample (47.3% vs 37.0%; P = not significant). The median response time for the PBRN was significantly shorter than that for the national sample (2 vs 28 days; P < .001). No significant differences were found between the PBRN and the Midwest subset of the national sample in the frequencies of major diagnostic categories or in case management. Electronic means of creating differential diagnoses for rare infectious diseases of national significance is feasible within PBRNs. Information is much more rapidly acquired and is consistent with that obtained by conventional methods.

How Important Is ‘Accuracy’ of Surrogate Decision-Making for Research Participation?

PubMed Central

Kim, Scott Y. H.; Kim, H. Myra; Ryan, Kerry A.; Appelbaum, Paul S.; Knopman, David S.; Damschroder, Laura; De Vries, Raymond

2013-01-01

Background There is a longstanding concern about the accuracy of surrogate consent in representing the health care and research preferences of those who lose their ability to decide for themselves. We sought informed, deliberative views of the older general public (≥50 years old) regarding their willingness to participate in dementia research and to grant leeway to future surrogates to choose an option contrary to their stated wishes. Methodology/Principal Findings 503 persons aged 50+ recruited by random digit dialing were randomly assigned to one of three groups: deliberation, education, or control. The deliberation group attended an all-day education/peer deliberation session; the education group received written information only. Participants were surveyed at baseline, after the deliberation session (or equivalent time), and one month after the session, regarding their willingness to participate in dementia research and to give leeway to surrogates, regarding studies of varying risk-benefit profiles (a lumbar puncture study, a drug randomized controlled trial, a vaccine randomized controlled trial, and an early phase gene transfer trial). At baseline, 48% (gene transfer scenario) to 92% (drug RCT) were willing to participate in future dementia research. A majority of respondents (57–71% depending on scenario) were willing to give leeway to future surrogate decision-makers. Democratic deliberation increased willingness to participate in all scenarios, to grant leeway in 3 of 4 scenarios (lumbar puncture, vaccine, and gene transfer), and to enroll loved ones in research in all scenarios. On average, respondents were more willing to volunteer themselves for research than to enroll their loved ones. Conclusions/Significance Most people were willing to grant leeway to their surrogates, and this willingness was either sustained or increased after democratic deliberation, suggesting that the attitude toward leeway is a reliable opinion. Eliciting a person’s current preferences about future research participation should also involve eliciting his or her leeway preferences. PMID:23382969

Differences in motivation and adherence to a prescribed assignment after face-to-face and online psychoeducation: an experimental study.

PubMed

Alfonsson, Sven; Johansson, Karin; Uddling, Jonas; Hursti, Timo

2017-01-26

Adherence to treatment homework is associated with positive outcomes in behavioral psychotherapy but compliance to assignments is still often moderate. Whether adherence can be predicted by different types of motivation for the task and whether motivation plays different roles in face-to-face compared to online psychotherapy is unknown. If models of motivation, such as Self-determination theory, can be used to predict patients' behavior, it may facilitate further research into homework promotion. The aims of this study were, therefore, to investigate whether motivation variables could predict adherence to a prescribed assignment in face-to-face and online interventions using a psychotherapy analog model. A total of 100 participants were included in this study and randomized to either a face-to-face or online intervention. Participants in both groups received a psychoeducation session and were given an assignment for the subsequent week. The main outcome measurements were self-reported motivation and adherence to the assignment. Participant in the face-to-face condition reported significantly higher levels of motivation and showed higher levels of adherence compared to participants in the online condition. Adherence to the assignment was positively associated with intrinsic motivation and intervention credibility in the whole sample and especially in the online group. This study shows that intrinsic motivation and intervention credibility are strong predictors of adherence to assignments, especially in online interventions. The results indicate that intrinsic motivation may be partly substituted with face-to-face contact with a therapist. It may also be possible to identify patients with low motivation in online interventions who are at risk of dropping out. Methods for making online interventions more intrinsically motivating without increasing external pressure are needed. clinicaltrials.gov NCT02895308 . Retrospectively registered 30 August 2016.

A Reengineered Hospital Discharge Program to Decrease Rehospitalization

PubMed Central

Jack, Brian W.; Chetty, Veerappa K.; Anthony, David; Greenwald, Jeffrey L.; Sanchez, Gail M.; Johnson, Anna E.; Forsythe, Shaula R.; O'Donnell, Julie K.; Paasche-Orlow, Michael K.; Manasseh, Christopher; Martin, Stephen; Culpepper, Larry

2009-01-01

Background: Emergency department visits and rehospitalization are common after hospital discharge. Objective: To test the effects of an intervention designed to minimize hospital utilization after discharge. Design: Randomized trial using block randomization of 6 and 8. Randomly arranged index cards were placed in opaque envelopes labeled consecutively with study numbers, and participants were assigned a study group by revealing the index card. Setting: General medical service at an urban, academic, safety-net hospital. Patients: 749 English-speaking hospitalized adults (mean age, 49.9 years). Intervention: A nurse discharge advocate worked with patients during their hospital stay to arrange follow-up appointments, confirm medication reconciliation, and conduct patient education with an individualized instruction booklet that was sent to their primary care provider. A clinical pharmacist called patients 2 to 4 days after discharge to reinforce the discharge plan and review medications. Participants and providers were not blinded to treatment assignment. Measurements: Primary outcomes were emergency department visits and hospitalizations within 30 days of discharge. Secondary outcomes were self-reported preparedness for discharge and frequency of primary care providers′ follow-up within 30 days of discharge. Research staff doing follow-up were blinded to study group assignment. Results: Participants in the intervention group (n = 370) had a lower rate of hospital utilization than those receiving usual care (n = 368) (0.314 vs. 0.451 visit per person per month; incidence rate ratio, 0.695 [95% CI, 0.515 to 0.937]; P = 0.009). The intervention was most effective among participants with hospital utilization in the 6 months before index admission (P = 0.014). Adverse events were not assessed; these data were collected but are still being analyzed. Limitation: This was a single-center study in which not all potentially eligible patients could be enrolled, and outcome assessment sometimes relied on participant report. Conclusion: A package of discharge services reduced hospital utilization within 30 days of discharge. PMID:19189907

Oral hygiene compliance in orthodontic patients: a randomized controlled study on the effects of a post-treatment communication.

PubMed

Cozzani, Mauro; Ragazzini, Giulia; Delucchi, Alessia; Mutinelli, Sabrina; Barreca, Carlo; Rinchuse, Daniel J; Servetto, Roberto; Piras, Vincenzo

2016-12-01

Several studies have recently demonstrated that a post-treatment communication to explain the importance of an oral hygiene can improve the orthodontic patients' compliance over a period of 66 days. The main goal of this study is to evaluate the effects of a structured follow-up communication after orthodontic appliance application on oral hygiene compliance after 30-40 days. Eighty-four orthodontic participants enrolled from patients who were beginning fixed orthodontic treatment at the Orthodontic Department, Gaslini Hospital, Genova, between July and October 2014 were randomly assigned to one of three trial arms. Before the bonding, all patients underwent a session of oral hygiene aimed at obtaining an plaque index of "zero." At the following orthodontic appointment, the plaque index was calculated for each patient in order to assess oral hygiene compliance. The first group served as control and did not receive any post-procedure communication, the second group received a structured text message giving reassurance, and the third group received a structured telephone call. Participants were blinded to group assignment and were not made aware that the text message or the telephone call was part of the study. (The research protocol was approved by the Italian Comitato Etico Regionale della Liguria-sezione 3^ c/o IRCCS-Istituto G. Gaslini 845/2014, and it is not registered in the trial's register.) RESULTS: Thirty patients were randomly assigned to the control group, 28 participants to the text message group, and 26 to the telephone group. Participants who received a post-treatment communication reported higher level of oral hygiene compliance than participants in the control group. The plaque index was 0.3 (interquartile range (Iqr), 0.60) and 0.75 (Iqr, 1.30), respectively, with a significant difference (P = 0.0205). A follow-up procedure after orthodontic treatment may be an effective tool to increase oral hygiene compliance also over a short period.

Does gratitude writing improve the mental health of psychotherapy clients? Evidence from a randomized controlled trial.

PubMed

Wong, Y Joel; Owen, Jesse; Gabana, Nicole T; Brown, Joshua W; McInnis, Sydney; Toth, Paul; Gilman, Lynn

2018-03-01

Although the past decade has witnessed growing research interest in positive psychological interventions (PPIs), their potential as adjunctive interventions for psychotherapy remains relatively unexplored. Therefore, this article expands the frontiers of PPI research by reporting the first randomized controlled trial to test a gratitude writing adjunctive intervention for psychotherapy clients. Participants were 293 adults seeking university-based psychotherapy services. Participants were randomly assigned to one of three conditions: (a) control (psychotherapy only), (b) a psychotherapy plus expressive writing, and (c) a psychotherapy plus gratitude writing. Participants in the gratitude condition wrote letters expressing gratitude to others, whereas those in the expressive writing condition wrote about their deepest thoughts and feelings about stressful experiences. About 4 weeks as well as 12 weeks after the conclusion of the writing intervention, participants in the gratitude condition reported significantly better mental health than those in the expressive and control conditions, whereas those in the expressive and control conditions did not differ significantly. Moreover, lower proportions of negative emotion words in participants' writing mediated the positive effect of condition (gratitude versus expressive writing) on mental health. These findings are discussed in light of the use of gratitude interventions as adjunctive interventions for psychotherapy clients.

Using Small-Scale Randomized Controlled Trials to Evaluate the Efficacy of New Curricular Materials

PubMed Central

Bass, Kristin M.; Stark, Louisa A.

2014-01-01

How can researchers in K–12 contexts stay true to the principles of rigorous evaluation designs within the constraints of classroom settings and limited funding? This paper explores this question by presenting a small-scale randomized controlled trial (RCT) designed to test the efficacy of curricular supplemental materials on epigenetics. The researchers asked whether the curricular materials improved students’ understanding of the content more than an alternative set of activities. The field test was conducted in a diverse public high school setting with 145 students who were randomly assigned to a treatment or comparison condition. Findings indicate that students in the treatment condition scored significantly higher on the posttest than did students in the comparison group (effect size: Cohen's d = 0.40). The paper discusses the strengths and limitations of the RCT, the contextual factors that influenced its enactment, and recommendations for others wishing to conduct small-scale rigorous evaluations in educational settings. Our intention is for this paper to serve as a case study for university science faculty members who wish to employ scientifically rigorous evaluations in K–12 settings while limiting the scope and budget of their work. PMID:25452482

USE OF NEUROFEEDBACK AND MINDFULNESS TO ENHANCE RESPONSE TO HYPNOSIS TREATMENT IN INDIVIDUALS WITH MULTIPLE SCLEROSIS: Results From a Pilot Randomized Clinical Trial.

PubMed

Jensen, Mark P; Battalio, Samuel L; Chan, Joy F; Edwards, Karlyn A; Day, Melissa A; Sherlin, Leslie H; Ehde, Dawn M

2018-01-01

This pilot study evaluated the possibility that 2 interventions hypothesized to increase slower brain oscillations (e.g., theta) may enhance the efficacy of hypnosis treatment, given evidence that hypnotic responding is associated with slower brain oscillations. Thirty-two individuals with multiple sclerosis and chronic pain, fatigue, or both, were randomly assigned to 1 of 2 interventions thought to increase slow wave activity (mindfulness meditation or neurofeedback training) or no enhancing intervention, and then given 5 sessions of self-hypnosis training targeting their presenting symptoms. The findings supported the potential for both neurofeedback and mindfulness to enhance response to hypnosis treatment. Research using larger sample sizes to determine the generalizability of these findings is warranted.

Diminishing the self-stigma of mental illness by coming out proud.

PubMed

Corrigan, Patrick W; Larson, Jonathon E; Michaels, Patrick J; Buchholz, Blythe A; Rossi, Rachel Del; Fontecchio, Malia Javier; Castro, David; Gause, Michael; Krzyżanowski, Richard; Rüsch, Nicolas

2015-09-30

This randomized controlled trial examined the impact of the Coming Out Proud (COP) program on self-stigma, stigma stress, and depression. Research participants who experienced mental health challenges were randomly assigned to a three session COP program (n=51) or a waitlist control (n=75). Outcome measures that assessed the progressively harmful stages of self-stigma, stigma stress appraisals, and depression were administered at pre-test, post-test, and one-month follow-up. People completing COP showed significant improvement at post-test and follow-up in the more harmful aspects of self-stigma compared to the control group. COP participants also showed improvements in stigma stress appraisals. Women participating in COP showed significant post-test and follow-up reductions in depression after COP compared to the control group. Men did not show this effect. Future research should determine whether these benefits also enhance attitudes related to recovery, empowerment, and self-determination. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Study protocol for a randomized controlled trial: tongue strengthening exercises in head and neck cancer patients, does exercise load matter?

PubMed

Van Nuffelen, Gwen; Van den Steen, Leen; Vanderveken, Olivier; Specenier, Pol; Van Laer, Carl; Van Rompaey, Diane; Guns, Cindy; Mariën, Steven; Peeters, Marc; Van de Heyning, Paul; Vanderwegen, Jan; De Bodt, Marc

2015-09-04

Reduced tongue strength is an important factor contributing to early and late dysphagia in head and neck cancer patients previously treated with chemoradiotherapy. The evidence is growing that tongue strengthening exercises can improve tongue strength and swallowing function in both healthy and dysphagic subjects. However, little is known about the impact of specific features of an exercise protocol for tongue strength on the actual outcome (strength or swallowing function). Previous research originating in the fields of sports medicine and physical rehabilitation shows that the degree of exercise load is an influential factor for increasing muscle strength in the limb skeletal muscles. Since the tongue is considered a muscular hydrostat, it remains to be proven whether the same concepts will apply. This ongoing randomized controlled trial in chemoradiotherapy-treated patients with head and neck cancer investigates the effect of three tongue strengthening exercise protocols, with different degrees of exercise load, on tongue strength and swallowing. At enrollment, 51 patients whose dysphagia is primarily related to reduced tongue strength are randomly assigned to a training schedule of 60, 80, or 100% of their maximal tongue strength. Patients are treated three times a week for 8 weeks, executing 120 repetitions of the assigned exercise once per training day. Exercise load is progressively adjusted every 2 weeks. Patients are evaluated before, during and after treatment by means of tongue strength measurements, fiber-optic endoscopic evaluation of swallowing and quality-of-life questionnaires. This randomized controlled trial is the first to systematically investigate the effect of different exercise loads in tongue strengthening exercise protocols. The results will allow the development of more efficacious protocols. Current Controlled Trials ISRCTN14447678.

The effects of the prevention program 'New Perspectives' (NP) on juvenile delinquency and other life domains: study protocol for a randomized controlled trial.

PubMed

de Vries, Sanne L A; Hoeve, Machteld; Asscher, Jessica J; Stams, Geert Jan Jm

2014-01-01

New Perspectives (NP) is a prevention program aiming to prevent that youth at onset of a criminal career will develop a persistent criminal behaviour pattern. The effects of NP on juvenile delinquency and other life domains are investigated, using a randomized controlled trial (RCT). In the present study at-risk youth aged 12 to 23 years are assigned randomly to the intervention (N = 90, NP) or control condition consisting of care as usual (N = 90, CAU). After screening, random assignment, and consent to participate, adolescents and their parents are requested to complete questionnaires. Data are collected at four points in time: at baseline (before the start of the intervention), after 3 months, after 6 months (post-test) and 1 year after treatment (follow-up). Primary outcome measures include involvement in delinquent behaviour and recidivism. Secondary outcome measures include parenting behaviour, life events, prosocial behaviour, deviant and prosocial peers, externalizing behaviour, cognitive distortions, moral reasoning, self-worth, anxiety, depression, client satisfaction, therapeutic alliance and motivation. Standardized questionnaires and interviews are used to collect data. Moderator analyses will also be conducted in order to examine the influence of ethnic background, gender and age on the program effectiveness. The present study will provide new insights in the effects of a prevention program targeting youth at risk for the development of a persistent criminal career. Dutch trial register number NTR4370. The study is financially supported by a grant from ZonMw, the Dutch Organization for Health research and Development, grant number 157004006. The study is approved by the Ethics Committee of the University of Amsterdam, approval number 2011-CDE-01.

A Randomized Trial of Progesterone in Women with Recurrent Miscarriages.

PubMed

Coomarasamy, Arri; Williams, Helen; Truchanowicz, Ewa; Seed, Paul T; Small, Rachel; Quenby, Siobhan; Gupta, Pratima; Dawood, Feroza; Koot, Yvonne E M; Bender Atik, Ruth; Bloemenkamp, Kitty W M; Brady, Rebecca; Briley, Annette L; Cavallaro, Rebecca; Cheong, Ying C; Chu, Justin J; Eapen, Abey; Ewies, Ayman; Hoek, Annemieke; Kaaijk, Eugenie M; Koks, Carolien A M; Li, Tin-Chiu; MacLean, Marjory; Mol, Ben W; Moore, Judith; Ross, Jackie A; Sharpe, Lisa; Stewart, Jane; Vaithilingam, Nirmala; Farquharson, Roy G; Kilby, Mark D; Khalaf, Yacoub; Goddijn, Mariette; Regan, Lesley; Rai, Rajendra

2015-11-26

Progesterone is essential for the maintenance of pregnancy. However, whether progesterone supplementation in the first trimester of pregnancy would increase the rate of live births among women with a history of unexplained recurrent miscarriages is uncertain. We conducted a multicenter, double-blind, placebo-controlled, randomized trial to investigate whether treatment with progesterone would increase the rates of live births and newborn survival among women with unexplained recurrent miscarriage. We randomly assigned women with recurrent miscarriages to receive twice-daily vaginal suppositories containing either 400 mg of micronized progesterone or matched placebo from a time soon after a positive urinary pregnancy test (and no later than 6 weeks of gestation) through 12 weeks of gestation. The primary outcome was live birth after 24 weeks of gestation. A total of 1568 women were assessed for eligibility, and 836 of these women who conceived naturally within 1 year and remained willing to participate in the trial were randomly assigned to receive either progesterone (404 women) or placebo (432 women). The follow-up rate for the primary outcome was 98.8% (826 of 836 women). In an intention-to-treat analysis, the rate of live births was 65.8% (262 of 398 women) in the progesterone group and 63.3% (271 of 428 women) in the placebo group (relative rate, 1.04; 95% confidence interval [CI], 0.94 to 1.15; rate difference, 2.5 percentage points; 95% CI, -4.0 to 9.0). There were no significant between-group differences in the rate of adverse events. Progesterone therapy in the first trimester of pregnancy did not result in a significantly higher rate of live births among women with a history of unexplained recurrent miscarriages. (Funded by the United Kingdom National Institute of Health Research; PROMISE Current Controlled Trials number, ISRCTN92644181.).

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

PubMed

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

2017-06-22

The role of supine positioning after acute stroke in improving cerebral blood flow and the countervailing risk of aspiration pneumonia have led to variation in head positioning in clinical practice. We wanted to determine whether outcomes in patients with acute ischemic stroke could be improved by positioning the patient to be lying flat (i.e., fully supine with the back horizontal and the face upwards) during treatment to increase cerebral perfusion. In a pragmatic, cluster-randomized, crossover trial conducted in nine countries, we assigned 11,093 patients with acute stroke (85% of the strokes were ischemic) to receive care in either a lying-flat position or a sitting-up position with the head elevated to at least 30 degrees, according to the randomization assignment of the hospital to which they were admitted; the designated position was initiated soon after hospital admission and was maintained for 24 hours. The primary outcome was degree of disability at 90 days, as assessed with the use of the modified Rankin scale (scores range from 0 to 6, with higher scores indicating greater disability and a score of 6 indicating death). The median interval between the onset of stroke symptoms and the initiation of the assigned position was 14 hours (interquartile range, 5 to 35). Patients in the lying-flat group were less likely than patients in the sitting-up group to maintain the position for 24 hours (87% vs. 95%, P<0.001). In a proportional-odds model, there was no significant shift in the distribution of 90-day disability outcomes on the global modified Rankin scale between patients in the lying-flat group and patients in the sitting-up group (unadjusted odds ratio for a difference in the distribution of scores on the modified Rankin scale in the lying-flat group, 1.01; 95% confidence interval, 0.92 to 1.10; P=0.84). Mortality within 90 days was 7.3% among the patients in the lying-flat group and 7.4% among the patients in the sitting-up group (P=0.83). There were no significant between-group differences in the rates of serious adverse events, including pneumonia. Disability outcomes after acute stroke did not differ significantly between patients assigned to a lying-flat position for 24 hours and patients assigned to a sitting-up position with the head elevated to at least 30 degrees for 24 hours. (Funded by the National Health and Medical Research Council of Australia; HeadPoST ClinicalTrials.gov number, NCT02162017 .).

Treatment assignment guesses by study participants in a double-blind dose escalation clinical trial of saw palmetto.

PubMed

Lee, Jeannette Y; Moore, Page; Kusek, John; Barry, Michael

2014-01-01

This report assesses participant perception of treatment assignment in a randomized, double-blind, placebo-controlled trial of saw palmetto for the treatment of benign prostatic hyperplasia (BCM). Participants randomized to receive saw palmetto were instructed to take one 320 mg gelcap daily for the first 24 weeks, two 320 mg gelcaps daily for the second 24 weeks, and three 320 mg gelcaps daily for the third 24 weeks. Study participants assigned to placebo were instructed to take the same number of matching placebo gelcaps in each time period. At 24, 48, and 72 weeks postrandomization, the American Urological Association Symptom Index (AUA-SI) was administered and participants were asked to guess their treatment assignment. The study was conducted at 11 clinical centers in North America. Study participants were men, 45 years and older, with moderate to low severe BPH symptoms, randomized to saw palmetto (N=151) or placebo (N=155). Treatment arms were compared with respect to the distribution of participant guesses of treatment assignment. For participants assigned to saw palmetto, 22.5%, 24.7%, and 29.8% correctly thought they were taking saw palmetto, and 37.3%, 40.0%, and 44.4% incorrectly thought they were on placebo at 24, 48, and 72 weeks, respectively. For placebo participants, 21.8%, 27.4%, and 25.2% incorrectly thought they were on saw palmetto, and 41.6%, 39.9%, and 42.6% correctly thought they were on placebo at 24, 48, and 72 weeks, respectively. The treatment arms did not vary with respect to the distributions of participants who guessed they were on saw palmetto (p=0.823) or placebo (p=0.893). Participants who experienced an improvement in AUA-SI were 2.16 times more likely to think they were on saw palmetto. Blinding of treatment assignment was successful in this study. Improvement in BPH-related symptoms was associated with the perception that participants were taking saw palmetto.

Efficacy and effectiveness of an rVSV-vectored vaccine in preventing Ebola virus disease: final results from the Guinea ring vaccination, open-label, cluster-randomised trial (Ebola Ça Suffit!).

PubMed

Henao-Restrepo, Ana Maria; Camacho, Anton; Longini, Ira M; Watson, Conall H; Edmunds, W John; Egger, Matthias; Carroll, Miles W; Dean, Natalie E; Diatta, Ibrahima; Doumbia, Moussa; Draguez, Bertrand; Duraffour, Sophie; Enwere, Godwin; Grais, Rebecca; Gunther, Stephan; Gsell, Pierre-Stéphane; Hossmann, Stefanie; Watle, Sara Viksmoen; Kondé, Mandy Kader; Kéïta, Sakoba; Kone, Souleymane; Kuisma, Eewa; Levine, Myron M; Mandal, Sema; Mauget, Thomas; Norheim, Gunnstein; Riveros, Ximena; Soumah, Aboubacar; Trelle, Sven; Vicari, Andrea S; Røttingen, John-Arne; Kieny, Marie-Paule

2017-02-04

rVSV-ZEBOV is a recombinant, replication competent vesicular stomatitis virus-based candidate vaccine expressing a surface glycoprotein of Zaire Ebolavirus. We tested the effect of rVSV-ZEBOV in preventing Ebola virus disease in contacts and contacts of contacts of recently confirmed cases in Guinea, west Africa. We did an open-label, cluster-randomised ring vaccination trial (Ebola ça Suffit!) in the communities of Conakry and eight surrounding prefectures in the Basse-Guinée region of Guinea, and in Tomkolili and Bombali in Sierra Leone. We assessed the efficacy of a single intramuscular dose of rVSV-ZEBOV (2×10 7 plaque-forming units administered in the deltoid muscle) in the prevention of laboratory confirmed Ebola virus disease. After confirmation of a case of Ebola virus disease, we definitively enumerated on a list a ring (cluster) of all their contacts and contacts of contacts including named contacts and contacts of contacts who were absent at the time of the trial team visit. The list was archived, then we randomly assigned clusters (1:1) to either immediate vaccination or delayed vaccination (21 days later) of all eligible individuals (eg, those aged ≥18 years and not pregnant, breastfeeding, or severely ill). An independent statistician generated the assignment sequence using block randomisation with randomly varying blocks, stratified by location (urban vs rural) and size of rings (≤20 individuals vs >20 individuals). Ebola response teams and laboratory workers were unaware of assignments. After a recommendation by an independent data and safety monitoring board, randomisation was stopped and immediate vaccination was also offered to children aged 6-17 years and all identified rings. The prespecified primary outcome was a laboratory confirmed case of Ebola virus disease with onset 10 days or more from randomisation. The primary analysis compared the incidence of Ebola virus disease in eligible and vaccinated individuals assigned to immediate vaccination versus eligible contacts and contacts of contacts assigned to delayed vaccination. This trial is registered with the Pan African Clinical Trials Registry, number PACTR201503001057193. In the randomised part of the trial we identified 4539 contacts and contacts of contacts in 51 clusters randomly assigned to immediate vaccination (of whom 3232 were eligible, 2151 consented, and 2119 were immediately vaccinated) and 4557 contacts and contacts of contacts in 47 clusters randomly assigned to delayed vaccination (of whom 3096 were eligible, 2539 consented, and 2041 were vaccinated 21 days after randomisation). No cases of Ebola virus disease occurred 10 days or more after randomisation among randomly assigned contacts and contacts of contacts vaccinated in immediate clusters versus 16 cases (7 clusters affected) among all eligible individuals in delayed clusters. Vaccine efficacy was 100% (95% CI 68·9-100·0, p=0·0045), and the calculated intraclass correlation coefficient was 0·035. Additionally, we defined 19 non-randomised clusters in which we enumerated 2745 contacts and contacts of contacts, 2006 of whom were eligible and 1677 were immediately vaccinated, including 194 children. The evidence from all 117 clusters showed that no cases of Ebola virus disease occurred 10 days or more after randomisation among all immediately vaccinated contacts and contacts of contacts versus 23 cases (11 clusters affected) among all eligible contacts and contacts of contacts in delayed plus all eligible contacts and contacts of contacts never vaccinated in immediate clusters. The estimated vaccine efficacy here was 100% (95% CI 79·3-100·0, p=0·0033). 52% of contacts and contacts of contacts assigned to immediate vaccination and in non-randomised clusters received the vaccine immediately; vaccination protected both vaccinated and unvaccinated people in those clusters. 5837 individuals in total received the vaccine (5643 adults and 194 children), and all vaccinees were followed up for 84 days. 3149 (53·9%) of 5837 individuals reported at least one adverse event in the 14 days after vaccination; these were typically mild (87·5% of all 7211 adverse events). Headache (1832 [25·4%]), fatigue (1361 [18·9%]), and muscle pain (942 [13·1%]) were the most commonly reported adverse events in this period across all age groups. 80 serious adverse events were identified, of which two were judged to be related to vaccination (one febrile reaction and one anaphylaxis) and one possibly related (influenza-like illness); all three recovered without sequelae. The results add weight to the interim assessment that rVSV-ZEBOV offers substantial protection against Ebola virus disease, with no cases among vaccinated individuals from day 10 after vaccination in both randomised and non-randomised clusters. WHO, UK Wellcome Trust, the UK Government through the Department of International Development, Médecins Sans Frontières, Norwegian Ministry of Foreign Affairs (through the Research Council of Norway's GLOBVAC programme), and the Canadian Government (through the Public Health Agency of Canada, Canadian Institutes of Health Research, International Development Research Centre and Department of Foreign Affairs, Trade and Development). Copyright © 2017 World Health Organization. Published by Elsevier Ltd/Inc/BV. All rights reserved. Published by Elsevier Ltd.. All rights reserved.

The lone gamer: Social exclusion predicts violent video game preferences and fuels aggressive inclinations in adolescent players.

PubMed

Gabbiadini, Alessandro; Riva, Paolo

2018-03-01

Violent video game playing has been linked to a wide range of negative outcomes, especially in adolescents. In the present research, we focused on a potential determinant of adolescents' willingness to play violent video games: social exclusion. We also tested whether exclusion can predict increased aggressiveness following violent video game playing. In two experiments, we predicted that exclusion could increase adolescents' preferences for violent video games and interact with violent game playing fostering adolescents' aggressive inclinations. In Study 1, 121 adolescents (aged 10-18 years) were randomly assigned to a manipulation of social exclusion. Then, they evaluated the violent content of nine different video games (violent, nonviolent, or prosocial) and reported their willingness to play each presented video game. The results showed that excluded participants expressed a greater willingness to play violent games than nonviolent or prosocial games. No such effect was found for included participants. In Study 2, both inclusionary status and video game contents were manipulated. After a manipulation of inclusionary status, 113 adolescents (aged 11-16 years) were randomly assigned to play either a violent or a nonviolent video game. Then, they were given an opportunity to express their aggressive inclinations toward the excluders. Results showed that excluded participants who played a violent game displayed the highest level of aggressive inclinations than participants who were assigned to the other experimental conditions. Overall, these findings suggest that exclusion increases preferences for violent games and that the combination of exclusion and violent game playing fuels aggressive inclinations. © 2017 Wiley Periodicals, Inc.

Inducing changes in arousal and valence: comparison of two mood induction procedures.

PubMed

Jallais, Christophe; Gilet, Anne-Laure

2010-02-01

This research examined the relative effectiveness of two mood induction procedures (MIPs) for inducing four specific moods varying along the dimensions of both valence and arousal. Participants were randomly assigned either to an autobiographical recall or to a music and guided imagery MIP and underwent a happiness, serenity, anger, or sadness mood induction. The findings confirmed the effectiveness of the two MIPs in producing changes on both the valence and arousal dimensions of mood. The results also revealed an unexpected greater efficiency of the autobiographical recall than of the combined procedure.

Nifedipine versus atosiban for threatened preterm birth (APOSTEL III): a multicentre, randomised controlled trial.

PubMed

van Vliet, Elvira O G; Nijman, Tobias A J; Schuit, Ewoud; Heida, Karst Y; Opmeer, Brent C; Kok, Marjolein; Gyselaers, Wilfried; Porath, Martina M; Woiski, Mallory; Bax, Caroline J; Bloemenkamp, Kitty W M; Scheepers, Hubertina C J; Jacquemyn, Yves; Beek, Erik van; Duvekot, Johannes J; Franssen, Maureen T M; Papatsonis, Dimitri N; Kok, Joke H; van der Post, Joris A M; Franx, Arie; Mol, Ben W; Oudijk, Martijn A

2016-05-21

In women with threatened preterm birth, delay of delivery by 48 h allows antenatal corticosteroids to improve neonatal outcomes. For this reason, tocolytics are often administered for 48 h; however, there is no consensus about which drug results in the best maternal and neonatal outcomes. In the APOSTEL III trial we aimed to compare the effectiveness and safety of the calcium-channel blocker nifedipine and the oxytocin inhibitor atosiban in women with threatened preterm birth. We did this multicentre, randomised controlled trial in ten tertiary and nine teaching hospitals in the Netherlands and Belgium. Women with threatened preterm birth (gestational age 25-34 weeks) were randomly assigned (1:1) to either oral nifedipine or intravenous atosiban for 48 h. An independent data manager used a web-based computerised programme to randomly assign women in permuted block sizes of four, with groups stratified by centre. Clinicians, outcome assessors, and women were not masked to treatment group. The primary outcome was a composite of adverse perinatal outcomes, which included perinatal mortality, bronchopulmonary dysplasia, sepsis, intraventricular haemorrhage, periventricular leukomalacia, and necrotising enterocolitis. Analysis was done in all women and babies with follow-up data. The study is registered at the Dutch Clinical Trial Registry, number NTR2947. Between July 6, 2011, and July 7, 2014, we randomly assigned 254 women to nifedipine and 256 to atosiban. Primary outcome data were available for 248 women and 297 babies in the nifedipine group and 255 women and 294 babies in the atosiban group. The primary outcome occurred in 42 babies (14%) in the nifedipine group and in 45 (15%) in the atosiban group (relative risk [RR] 0·91, 95% CI 0·61-1·37). 16 (5%) babies died in the nifedipine group and seven (2%) died in the atosiban group (RR 2·20, 95% CI 0·91-5·33); all deaths were deemed unlikely to be related to the study drug. Maternal adverse events did not differ between groups. In women with threatened preterm birth, 48 h of tocolysis with nifedipine or atosiban results in similar perinatal outcomes. Future clinical research should focus on large placebo-controlled trials, powered for perinatal outcomes. ZonMw (the Netherlands Organisation for Health Research and Development). Copyright © 2016 Elsevier Ltd. All rights reserved.

A multiple imputation strategy for sequential multiple assignment randomized trials

PubMed Central

Shortreed, Susan M.; Laber, Eric; Stroup, T. Scott; Pineau, Joelle; Murphy, Susan A.

2014-01-01

Sequential multiple assignment randomized trials (SMARTs) are increasingly being used to inform clinical and intervention science. In a SMART, each patient is repeatedly randomized over time. Each randomization occurs at a critical decision point in the treatment course. These critical decision points often correspond to milestones in the disease process or other changes in a patient’s health status. Thus, the timing and number of randomizations may vary across patients and depend on evolving patient-specific information. This presents unique challenges when analyzing data from a SMART in the presence of missing data. This paper presents the first comprehensive discussion of missing data issues typical of SMART studies: we describe five specific challenges, and propose a flexible imputation strategy to facilitate valid statistical estimation and inference using incomplete data from a SMART. To illustrate these contributions, we consider data from the Clinical Antipsychotic Trial of Intervention and Effectiveness (CATIE), one of the most well-known SMARTs to date. PMID:24919867

Memory consolidation and contextual interference effects with computer games.

PubMed

Shewokis, Patricia A

2003-10-01

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

Efficacy of abstinence promotion media messages: findings from an online randomized trial.

PubMed

Evans, W Douglas; Davis, Kevin C; Ashley, Olivia Silber; Blitstein, Jonathan; Koo, Helen; Zhang, Yun

2009-10-01

We conducted an online randomized experiment to evaluate the efficacy of messages from the Parents Speak Up National Campaign (PSUNC) to promote parent-child communication about sex. We randomly assigned a national sample of 1,969 mothers and fathers to treatment (PSUNC exposure) and control (no exposure) conditions. Mothers were further randomized into treatment and booster (additional messages) conditions to evaluate dose-response effects. Participants were surveyed at baseline, 4 weeks postexposure, and 6 months postexposure. We used multivariable logistic regression procedures in our analysis. Treatment fathers were more likely than control fathers to initiate conversations about sex at 4 weeks, and treatment fathers and mothers were more likely than controls at 6 months to recommend that their children wait to have sex. Treatment fathers and mothers were far more likely than controls to use the campaign Web site. There was a dose-response effect for mothers' Web site use. Using new media methods, this study shows that PSUNC messages are efficacious in promoting parent-child communication about sex and abstinence. Future research should evaluate mechanisms and effectiveness in natural settings.

Methodological Issues in Research on Web-Based Behavioral Interventions

PubMed Central

Danaher, Brian G; Seeley, John R

2013-01-01

Background Web-based behavioral intervention research is rapidly growing. Purpose We review methodological issues shared across Web-based intervention research to help inform future research in this area. Methods We examine measures and their interpretation using exemplar studies and our research. Results We report on research designs used to evaluate Web-based interventions and recommend newer, blended designs. We review and critique methodological issues associated with recruitment, engagement, and social validity. Conclusions We suggest that there is value to viewing this burgeoning realm of research from the broader context of behavior change research. We conclude that many studies use blended research designs, that innovative mantling designs such as the Multiphase Optimization Strategy and Sequential Multiple Assignment Randomized Trial methods hold considerable promise and should be used more widely, and that Web-based controls should be used instead of usual care or no-treatment controls in public health research. We recommend topics for future research that address participant recruitment, engagement, and social validity. PMID:19806416

Group Counseling With Emotionally Disturbed School Children in Taiwan.

ERIC Educational Resources Information Center

Chiu, Peter

The application of group counseling to emotionally disturbed school children in Chinese culture was examined. Two junior high schools located in Tao-Yuan Province were randomly selected with two eighth-grade classes randomly selected from each school. Ten emotionally disturbed students were chosen from each class and randomly assigned to two…

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

ERIC Educational Resources Information Center

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

2016-01-01

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

Outcomes from a School-Randomized Controlled Trial of Steps to Respect: A Bullying Prevention Program

ERIC Educational Resources Information Center

Brown, Eric C.; Low, Sabina; Smith, Brian H.; Haggerty, Kevin P.

2011-01-01

This study reports the outcomes of a randomized controlled trial of Steps to Respect: A Bullying Prevention Program conducted in 33 California elementary schools. Schools were matched on school demographic characteristics and assigned randomly to intervention or waitlisted control conditions. Outcome measures were obtained from (a) all school…

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…

Randomized Clinical Trial Replication of a Psychosocial Treatment for Children with High-Functioning Autism Spectrum Disorders

ERIC Educational Resources Information Center

Thomeer, Marcus L.; Lopata, Christopher; Volker, Martin A.; Toomey, Jennifer A.; Lee, Gloria K.; Smerbeck, Audrey M.; Rodgers, Jonathan D.; McDonald, Christin A.; Smith, Rachael A.

2012-01-01

This replication randomized clinical trial examined the efficacy of a comprehensive psychosocial intervention for children aged 7 to 12 years with high-functioning autism spectrum disorders (HFASDs). Participants were randomly assigned to treatment or wait-list conditions. Treatment included instruction and therapeutic activities targeting social…

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…

Effects of combination oral care on oral health, dry mouth and salivary pH of intubated patients: A randomized controlled trial.

PubMed

Jang, Chun Sun; Shin, Yong Soon

2016-10-01

Intubated patients are at risk of oral health problems. Although a variety of oral care regimens for intubated patients have been studied, there is a lack of research on the effects of combination oral care that includes tooth brushing, chlorhexidine and cold water. This open-labelled, randomized, controlled trial aimed to evaluate the effects of combination oral care on oral health status. Participants aged 20 years and older were recruited on the first day after intubation through convenience sampling in a medical intensive care unit. Random assignment was performed using an internet randomization service. The primary outcome was oral health status. Data were collected during May and June 2013. Participants were randomized to one of two groups (23 intervention and 21 control). The final analysis included 18 patients with combination oral care and 17 in the control group. The intervention group had better oral health (effect size = 1.56), less dry mouth and higher salivary pH than the control group. Any additional burden of providing combination oral care to patients who are mechanically ventilated is worthwhile in terms of clinical outcomes. © 2016 John Wiley & Sons Australia, Ltd.

A videotape intervention to enhance the informed consent process for medical and psychiatric treatment research.

PubMed

Wirshing, Donna A; Sergi, Mark J; Mintz, Jim

2005-01-01

This study evaluated a brief educational video designed to enhance the informed consent process for people with serious mental and medical illnesses who are considering participating in treatment research. Individuals with schizophrenia who were being recruited for ongoing clinical trials, medical patients without self-reported psychiatric comorbidity, and university undergraduates were randomly assigned to view either a highly structured instructional videotape about the consent process in treatment research or a control videotape that presented only general information about bioethical issues in human research. Knowledge about informed consent was measured before and after viewing. Viewing the experimental videotape resulted in larger gains in knowledge about informed consent. Standardized effect sizes were large in all groups. The videotape was thus an effective teaching tool across diverse populations, ranging from individuals with severe chronic mental illness to university undergraduates.

Effects of active/passive interventions on pain, anxiety, and quality of life in women with fibromyalgia: Randomized controlled pilot trial.

PubMed

Ekici, Gamze; Unal, Edibe; Akbayrak, Turkan; Vardar-Yagli, Naciye; Yakut, Yavuz; Karabulut, Erdem

2017-01-01

The authors of this study compared the effects of pilates exercises and connective tissue massage (CTM) on pain intensity; pain-pressure threshold; and tolerance, anxiety, progress, and health-related quality of life in females with fibromyalgia. It was a pilot, assessor masked, randomized controlled trial conducted between January and August of 2013. Twenty-one women with fibromyalgia were randomly assigned to the pilates exercise program (six of whom did not complete the program), and 22 were randomly assigned to CTM (one of whom did not complete this program). Each group received the assigned intervention three times per week during a 4-week period. The Visual Analogue Scale, algometry, State-Trait Anxiety Inventory, Fibromyalgia Impact Questionnaire, and Nottingham Health Profile were used at baseline and at the end of treatments. Significant improvements were found in both groups for all parameters. However, the scores for pain-pressure threshold were significantly elevated and the symptoms of anxiety were significantly diminished in the exercise group compared to the massage group. Thus, exercise and massage might be used to provide improvements in women with fibromyalgia. The exercise group showed more advantages than the massage group and thus might be preferred for patients with fibromyalgia. However, an adequately powered trial is required to determine this with certainty.

Effectiveness of a nurse-led intensive home-visitation programme for first-time teenage mothers (Building Blocks): a pragmatic randomised controlled trial

PubMed Central

Robling, Michael; Bekkers, Marie-Jet; Bell, Kerry; Butler, Christopher C; Cannings-John, Rebecca; Channon, Sue; Martin, Belen Corbacho; Gregory, John W; Hood, Kerry; Kemp, Alison; Kenkre, Joyce; Montgomery, Alan A; Moody, Gwenllian; Owen-Jones, Eleri; Pickett, Kate; Richardson, Gerry; Roberts, Zoë E S; Ronaldson, Sarah; Sanders, Julia; Stamuli, Eugena; Torgerson, David

2016-01-01

Summary Background Many countries now offer support to teenage mothers to help them to achieve long-term socioeconomic stability and to give a successful start to their children. The Family Nurse Partnership (FNP) is a licensed intensive home-visiting intervention developed in the USA and introduced into practice in England that involves up to 64 structured home visits from early pregnancy until the child's second birthday by specially recruited and trained family nurses. We aimed to assess the effectiveness of giving the programme to teenage first-time mothers on infant and maternal outcomes up to 24 months after birth. Methods We did a pragmatic, non-blinded, randomised controlled, parallel-group trial in community midwifery settings at 18 partnerships between local authorities and primary and secondary care organisations in England. Eligible participants were nulliparous and aged 19 years or younger, and were recruited at less than 25 weeks' gestation. Field-based researchers randomly allocated mothers (1:1) via remote randomisation (telephone and web) to FNP plus usual care (publicly funded health and social care) or to usual care alone. Allocation was stratified by site and minimised by gestation (<16 weeks vs ≥16 weeks), smoking status (yes vs no), and preferred language of data collection (English vs non-English). Mothers and assessors (local researchers at baseline and 24 months' follow-up) were not masked to group allocation, but telephone interviewers were blinded. Primary endpoints were biomarker-calibrated self-reported tobacco use by the mother at late pregnancy, birthweight of the baby, the proportion of women with a second pregnancy within 24 months post-partum, and emergency attendances and hospital admissions for the child within 24 months post-partum. Analyses were by intention to treat. This trial is registered with ISRCTN, number ISRCTN23019866. Findings Between June 16, 2009, and July 28, 2010, we screened 3251 women. After enrolment, 823 women were randomly assigned to receive FNP and 822 to usual care. All follow-up data were retrieved by April 25, 2014. 304 (56%) of 547 women assigned to FNP and 306 (56%) of 545 assigned to usual care smoked at late pregnancy (adjusted odds ratio [AOR] 0·90, 97·5% CI 0·64–1·28). Mean birthweight of 742 babies with mothers assigned to FNP was 3217·4 g (SD 618·0), whereas birthweight of 768 babies assigned to usual care was 3197·5 g (SD 581·5; adjusted mean difference 20·75 g, 97·5% CI −47·73 to 89·23. 587 (81%) of 725 assessed children with mothers assigned to FNP and 577 (77%) of 753 assessed children assigned to usual care attended an emergency department or were admitted to hospital at least once before their second birthday (AOR 1·32, 97·5% CI 0·99–1·76). 426 (66%) of 643 assessed women assigned to FNP and 427 (66%) 646 assigned to usual care had a second pregnancy within 2 years (AOR 1·01, 0·77–1·33). At least one serious adverse event (mainly clinical events associated with pregnancy and infancy period) was reported for 310 (38%) of 808 participants (mother–child) in the usual care group and 357 (44%) of 810 in the FNP group, none of which were considered related to the intervention. Interpretation Adding FNP to the usually provided health and social care provided no additional short-term benefit to our primary outcomes. Programme continuation is not justified on the basis of available evidence, but could be reconsidered should supportive longer-term evidence emerge. Funding Department of Health Policy Research Programme. PMID:26474809

Therapeutic touch and postoperative pain: a Rogerian research study.

PubMed

Meehan, T C

1993-01-01

This article details Meehan's research study concerning the conceptualization of therapeutic touch within Rogers' science of unitary human beings and an investigation of the effects of therapeutic touch on pain experience in postoperative patients. Using a single trial, single-blind, three-group design, 108 postoperative patients were randomly assigned to receive one of the following: therapeutic touch, a placebo control intervention which mimicked therapeutic touch, or the standard intervention of a narcotic analgesic. Using a visual analogue scale, pain was measured before and one hour following intervention. The hypothesis, that therapeutic touch would significantly decrease postoperative pain compared to the placebo control intervention, was not supported. Secondary analyses suggest that therapeutic touch may decrease patients' need for analgesic medication. Implications for further research and practice are suggested.

The temporal limits of cognitive change from music therapy in elderly persons with dementia or dementia-like cognitive impairment: a randomized controlled trial.

PubMed

Bruer, Robert A; Spitznagel, Edward; Cloninger, C Robert

2007-01-01

This study explored the temporal limits of cognitive change from an intention-to-treat with group music therapy. Elderly cognitively-impaired psychiatric inpatients (N = 28) participated in an 8-week randomized control trial using a crossover design. Once a week, subjects were assigned either to music therapy or a control treatment (age-appropriate movie). The Mini-Mental State Exam (MMSE) assessed cognition 3 times every week: prior to the intervention, immediately after the mid-afternoon intervention, and the morning following the intervention. Comparisons between conditions included weekly changes in individual subject's MMSE scores from weekly baseline to both the 2 follow-ups and the following week's baseline. Significant next morning improvements in MMSE scores were found within intent-to-treat music therapy cases as compared to control cases. While all the subjects in this study were cognitively impaired, only 17 had been formally diagnosed with dementia. Based on a Cochrane Collaboration suggestion that music therapy studies within geriatric populations look specifically at the treatment of dementia, a final generalized estimating equation model considered only the change within the 17 dementia-diagnosed subjects. Immediately after the intervention, MMSE scores in the dementia-diagnosed subjects assigned to music therapy improved 2.00 points compared to the dementia-diagnosed subjects assigned to the control group (Z = 1.99, p < .05). Next-day MMSE test scores in the dementia-diagnosed subjects assigned to music therapy showed average improvements of 3.69 points compared to the control subjects (Z = 3.38, p < .001). By the following week, no significant cognitive differences remained between the two groups. It was concluded that a reasonable music therapy intervention facilitated by a trained and accredited music therapist significantly improved next-morning cognitive functioning among dementia patients. With many music therapists working in geriatric settings, more research is justified to both replicate this study and provide better guidance into the effective use of music therapy in the treatment of dementia.

Anxiety and Health-Related Quality of Life Among Patients With Low–Tumor Burden Non-Hodgkin Lymphoma Randomly Assigned to Two Different Rituximab Dosing Regimens: Results From ECOG Trial E4402 (RESORT)

PubMed Central

Wagner, Lynne I.; Zhao, Fengmin; Hong, Fangxin; Williams, Michael E.; Gascoyne, Randy D.; Krauss, John C.; Advani, Ranjana H.; Go, Ronald S.; Habermann, Thomas M.; Leach, Joseph W.; O'Connor, Brian; Schuster, Stephen J.; Cella, David; Horning, Sandra J.; Kahl, Brad S.

2015-01-01

Purpose The purpose of this study was to compare illness-related anxiety among participants in the Rituximab Extended Schedule or Retreatment Trial (RESORT) randomly assigned to maintenance rituximab (MR) versus rituximab re-treatment (RR). A secondary objective was to examine whether the superiority of MR versus RR on anxiety depended on illness-related coping style. Patients and Methods Patients (N = 253) completed patient-reported outcome (PRO) measures at random assignment to MR or RR (baseline); at 3, 6, 12, 24, 36, and 48 months after random assignment; and at rituximab failure. PRO measures assessed illness-related anxiety and coping style, and secondary end points including general anxiety, worry and interference with emotional well-being, depression, and health-related quality of life (HRQoL). Patients were classified as using an active or avoidant illness-related coping style. Independent sample t tests and linear mixed-effects models were used to identify treatment arm differences on PRO end points and differences based on coping style. Results Illness-related anxiety was comparable between treatment arms at all time points (P > .05), regardless of coping style (active or avoidant). Illness-related anxiety and general anxiety significantly decreased over time on both arms. HRQoL scores were relatively stable and did not change significantly from baseline for both arms. An avoidant coping style was associated with significantly higher anxiety (18% and 13% exceeded clinical cutoff points at baseline and 6 months, respectively) and poorer HRQoL compared with an active coping style (P < .001), regardless of treatment arm assignment. Conclusion Surveillance until RR at progression was not associated with increased anxiety compared with MR, regardless of coping style. Avoidant coping was associated with higher anxiety and poorer HRQoL. PMID:25605841

Partnerships for the Design, Conduct, and Analysis of Effectiveness, and Implementation Research: Experiences of the Prevention Science and Methodology Group

PubMed Central

Brown, C. Hendricks; Kellam, Sheppard G.; Kaupert, Sheila; Muthén, Bengt O.; Wang, Wei; Muthén, Linda K.; Chamberlain, Patricia; PoVey, Craig L.; Cady, Rick; Valente, Thomas W.; Ogihara, Mitsunori; Prado, Guillermo J.; Pantin, Hilda M.; Gallo, Carlos G.; Szapocznik, José; Czaja, Sara J.; McManus, John W.

2012-01-01

What progress prevention research has made comes through strategic partnerships with communities and institutions that host this research, as well as professional and practice networks that facilitate the diffusion of knowledge about prevention. We discuss partnership issues related to the design, analysis, and implementation of prevention research and especially how rigorous designs, including random assignment, get resolved through a partnership between community stakeholders, institutions, and researchers. These partnerships shape not only study design, but they determine the data that can be collected and how results and new methods are disseminated. We also examine a second type of partnership to improve the implementation of effective prevention programs into practice. We draw on social networks to studying partnership formation and function. The experience of the Prevention Science and Methodology Group, which itself is a networked partnership between scientists and methodologists, is highlighted. PMID:22160786

Partnerships for the design, conduct, and analysis of effectiveness, and implementation research: experiences of the prevention science and methodology group.

PubMed

Brown, C Hendricks; Kellam, Sheppard G; Kaupert, Sheila; Muthén, Bengt O; Wang, Wei; Muthén, Linda K; Chamberlain, Patricia; PoVey, Craig L; Cady, Rick; Valente, Thomas W; Ogihara, Mitsunori; Prado, Guillermo J; Pantin, Hilda M; Gallo, Carlos G; Szapocznik, José; Czaja, Sara J; McManus, John W

2012-07-01

What progress prevention research has made comes through strategic partnerships with communities and institutions that host this research, as well as professional and practice networks that facilitate the diffusion of knowledge about prevention. We discuss partnership issues related to the design, analysis, and implementation of prevention research and especially how rigorous designs, including random assignment, get resolved through a partnership between community stakeholders, institutions, and researchers. These partnerships shape not only study design, but they determine the data that can be collected and how results and new methods are disseminated. We also examine a second type of partnership to improve the implementation of effective prevention programs into practice. We draw on social networks to studying partnership formation and function. The experience of the Prevention Science and Methodology Group, which itself is a networked partnership between scientists and methodologists, is highlighted.

Effectiveness of an Extended Yoga Treatment for Women with Chronic Posttraumatic Stress Disorder

PubMed Central

Price, Maggi; Musicaro, Regina; Turner, Jennifer; Suvak, Michael; Emerson, David; van der Kolk, Bessel

2017-01-01

Abstract Background: Yoga has been found to be an effective posttraumatic stress disorder (PTSD) treatment for a variety of trauma survivors, including females with chronic PTSD. Aim/Purpose: The current study builds on extant research by examining an extended trauma-sensitive yoga treatment for women with chronic PTSD. The study sought to optimize the results of a treatment protocol examined in a recent randomized controlled trial with a shorter duration and without assignment or monitoring of home practice. Materials and Methods: The authors examined a 20-week trauma-sensitive yoga treatment in a non-randomized single-group treatment feasibility study for women with chronic treatment-resistant PTSD (N = 9). The authors examined PTSD and dissociation symptom reduction over several assessment periods. Results: The results indicate that participants experienced significant reductions in PTSD and dissociative symptomatology above and beyond similar treatments of a shorter duration. Conclusions: The findings suggest that more intensive trauma-sensitive yoga treatment characterized by longer duration and intentional assignment and monitoring of home practice may be more advantageous for individuals with severe and chronic PTSD. The implications of the findings for the potentially more substantial role of yoga as an intervention for a subset of adults with chronic treatment-resistant PTSD are discussed. PMID:28121466

Persistence of the effect of the Lung Health Study (LHS) smoking intervention over eleven years.

PubMed

Murray, Robert P; Connett, John E; Rand, Cynthia S; Pan, Wei; Anthonisen, Nicholas R

2002-10-01

Research on the long-term persistence of effects of interventions aimed at smoking cessation is limited. This paper examined the quitting behavior of individuals who were randomized to a smoking cessation intervention (SI) or to usual care (UC), at a point approximately 11 years later. The initial sample consisted of 5,887 adult smokers in 10 clinics who had evidence of airways obstruction. Two-thirds of the original participants were offered an intensive 12-week smoking cessation intervention. Of these, 4,517 were enrolled in the long-term follow-up study. Randomized group assignment was a strong predictor of smoking behavior after 11 years, in that 21.9% of SI participants and only 6.0% of UC participants maintained abstinence throughout the interval. Logistic regressions identified covariates associated with abstinence. A higher proportion of abstinence was observed in participants that had been assigned to SI (OR = 4.45), were older (OR = 1.11, increment 5 years), had more years of education (OR = 1.05), and fewer cigarettes/day at baseline (OR = 0.90, increment 10 cigarettes). Smokers exposed to an aggressive smoking intervention program and who sustain abstinence for a five-year period are very likely to still be abstinent after 11 years. Copyright 2002 American Health Foundation and Elsevier Science (USA)

Improving parenting skills for families of young children in pediatric settings: a randomized clinical trial.

PubMed

Perrin, Ellen C; Sheldrick, R Christopher; McMenamy, Jannette M; Henson, Brandi S; Carter, Alice S

2014-01-01

Disruptive behavior disorders, such as attention-deficient/hyperactivity disorder and oppositional defiant disorder, are common and stable throughout childhood. These disorders cause long-term morbidity but benefit from early intervention. While symptoms are often evident before preschool, few children receive appropriate treatment during this period. Group parent training, such as the Incredible Years program, has been shown to be effective in improving parenting strategies and reducing children's disruptive behaviors. Because they already monitor young children's behavior and development, primary care pediatricians are in a good position to intervene early when indicated. To investigate the feasibility and effectiveness of parent-training groups delivered to parents of toddlers in pediatric primary care settings. This randomized clinical trial was conducted at 11 diverse pediatric practices in the Greater Boston area. A total of 273 parents of children between 2 and 4 years old who acknowledged disruptive behaviors on a 20-item checklist were included. A 10-week Incredible Years parent-training group co-led by a research clinician and a pediatric staff member. Self-reports and structured videotaped observations of parent and child behaviors conducted prior to, immediately after, and 12 months after the intervention. A total of 150 parents were randomly assigned to the intervention or the waiting-list group. An additional 123 parents were assigned to receive intervention without a randomly selected comparison group. Compared with the waiting-list group, greater improvement was observed in both intervention groups (P < .05). No differences were observed between the randomized and the nonrandomized intervention groups. Self-reports and structured observations provided evidence of improvements in parenting practices and child disruptive behaviors that were attributable to participation in the Incredible Years groups. This study demonstrated the feasibility and effectiveness of parent-training groups conducted in pediatric office settings to reduce disruptive behavior in toddlers. clinicaltrials.gov Identifier: NCT00402857.

Preventing smoking relapse via Web-based computer-tailored feedback: a randomized controlled trial.

PubMed

Elfeddali, Iman; Bolman, Catherine; Candel, Math J J M; Wiers, Reinout W; de Vries, Hein

2012-08-20

Web-based computer-tailored approaches have the potential to be successful in supporting smoking cessation. However, the potential effects of such approaches for relapse prevention and the value of incorporating action planning strategies to effectively prevent smoking relapse have not been fully explored. The Stay Quit for You (SQ4U) study compared two Web-based computer-tailored smoking relapse prevention programs with different types of planning strategies versus a control group. To assess the efficacy of two Web-based computer-tailored programs in preventing smoking relapse compared with a control group. The action planning (AP) program provided tailored feedback at baseline and invited respondents to do 6 preparatory and coping planning assignments (the first 3 assignments prior to quit date and the final 3 assignments after quit date). The action planning plus (AP+) program was an extended version of the AP program that also provided tailored feedback at 11 time points after the quit attempt. Respondents in the control group only filled out questionnaires. The study also assessed possible dose-response relationships between abstinence and adherence to the programs. The study was a randomized controlled trial with three conditions: the control group, the AP program, and the AP+ program. Respondents were daily smokers (N = 2031), aged 18 to 65 years, who were motivated and willing to quit smoking within 1 month. The primary outcome was self-reported continued abstinence 12 months after baseline. Logistic regression analyses were conducted using three samples: (1) all respondents as randomly assigned, (2) a modified sample that excluded respondents who did not make a quit attempt in conformance with the program protocol, and (3) a minimum dose sample that also excluded respondents who did not adhere to at least one of the intervention elements. Observed case analyses and conservative analyses were conducted. In the observed case analysis of the randomized sample, abstinence rates were 22% (45/202) in the control group versus 33% (63/190) in the AP program and 31% (53/174) in the AP+ program. The AP program (odds ratio 1.95, P = .005) and the AP+ program (odds ratio 1.61, P = .049) were significantly more effective than the control condition. Abstinence rates and effects differed per sample. Finally, the results suggest a dose-response relationship between abstinence and the number of program elements completed by the respondents. Despite the differences in results caused by the variation in our analysis approaches, we can conclude that Web-based computer-tailored programs combined with planning strategy assignments and feedback after the quit attempt can be effective in preventing relapse 12 months after baseline. However, adherence to the intervention seems critical for effectiveness. Finally, our results also suggest that more research is needed to assess the optimum intervention dose. Dutch Trial Register: NTR1892; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1892 (Archived by WebCite at http://www.webcitation.org/693S6uuPM).

Cracking down on Youth Tobacco May Influence Drug Use

ERIC Educational Resources Information Center

Jason, Leonard A.; Pokorny, Steven B.; Adams, Monica; Nihls, Annie; Kim, Hyo Yeon; Hunt, Yvonne

2010-01-01

This study evaluated the influence of tobacco possession-use-purchase (PUP) law enforcement and illicit drug use and offers. Twenty-four towns were randomly assigned into two conditions. Both conditions focused on reducing minors' access to commercial sources of tobacco. The communities assigned to the experimental condition also increased their…

The Effect on One's Own Performance of Evaluating Peers.

ERIC Educational Resources Information Center

Cohen, Stuart J.

Fifty-three high school males took a minicourse on library usage. All were randomly assigned a topic and given response sheets requiring the use of dictionaries, encyclopedias, periodicals, and books. In a discussion session, all received instructional handouts. Students were assigned either to evaluating two peers' pretests (experimental) or…

Extended Mnemonic Instruction with Learning Disabled Students.

ERIC Educational Resources Information Center

Tolfa, Debra; And Others

Sixty-four learning disabled sixth, seventh, and eighth grade students were assigned to 24 small instructional groups which were in turn assigned at random to mnemonic and control conditions. Instructional groups were then given three daily lessons on dinosaurs in counterbalanced order. The lessons involved dinosaur vocabulary, attributes of…

10 CFR 26.405 - Drug and alcohol testing.

Code of Federal Regulations, 2011 CFR

2011-01-01

...; and (4) Provide that an individual completing a test is immediately eligible for another random test... following conditions: (1) Pre-assignment. Before assignment to construct or direct the construction of... individual is engaging in substance abuse, as defined in § 26.5; (3) Post-accident. As soon as practical...

10 CFR 26.405 - Drug and alcohol testing.

Code of Federal Regulations, 2013 CFR

2013-01-01

...; and (4) Provide that an individual completing a test is immediately eligible for another random test... following conditions: (1) Pre-assignment. Before assignment to construct or direct the construction of... individual is engaging in substance abuse, as defined in § 26.5; (3) Post-accident. As soon as practical...

10 CFR 26.405 - Drug and alcohol testing.

Code of Federal Regulations, 2010 CFR

2010-01-01

...; and (4) Provide that an individual completing a test is immediately eligible for another random test... following conditions: (1) Pre-assignment. Before assignment to construct safety-or security-related SSCs; (2..., as defined in § 26.5; (3) Post-accident. As soon as practical after an event involving a human error...

10 CFR 26.405 - Drug and alcohol testing.

Code of Federal Regulations, 2014 CFR

2014-01-01

...; and (4) Provide that an individual completing a test is immediately eligible for another random test... following conditions: (1) Pre-assignment. Before assignment to construct or direct the construction of... individual is engaging in substance abuse, as defined in § 26.5; (3) Post-accident. As soon as practical...

10 CFR 26.405 - Drug and alcohol testing.

Code of Federal Regulations, 2012 CFR

2012-01-01

...; and (4) Provide that an individual completing a test is immediately eligible for another random test... following conditions: (1) Pre-assignment. Before assignment to construct or direct the construction of... individual is engaging in substance abuse, as defined in § 26.5; (3) Post-accident. As soon as practical...

The effect of images of Michelle Obama's face on trick-or-treaters' dietary choices: A randomized control trial.

PubMed

Aronow, Peter M; Karlan, Dean; Pinson, Lauren E

2018-01-01

To evaluate the microfoundations of a personality-inspired public health campaign's influence on minors. Multi-year randomized control trial. Economics professor's front porch in New Haven, CT. 1223 trick-or-treaters in New Haven over three years; on average, 8.5 years old and 53% male (among children whose gender was identifiable). Trick-or-treaters over the age of three that approached the house. Random assignment to the Michelle Obama side of the porch or the Comparison side of the porch. Selection of fruit over candy. Difference-in-means estimates. We estimate that viewing a photograph of Michelle Obama's face relative to control conditions caused children to be 19% more likely to choose fruit over candy. Michelle Obama's initiative to reduce childhood obesity has influenced children's dietary preferences. Whether this influence extends beyond Halloween trick-or-treating in New Haven, CT on the porch of an economics professor requires further research.

A randomized controlled trial on the efficacy of thoracic CT screening for lung cancer in non-smokers and smokers of <30 pack-years aged 50-64 years (JECS study): research design.

PubMed

Sagawa, Motoyasu; Nakayama, Tomio; Tanaka, Makoto; Sakuma, Tsutomu; Sobue, Tomotaka

2012-12-01

In order to assess the efficacy of lung cancer screening using low-dose thoracic computed tomography, compared with chest roentgenography, in people aged 50-64 years with a smoking history of <30 pack-years, a randomized controlled trial is being conducted in Japan. The screening methods are randomly assigned individually. The duration of this trial is 10 years. In the intervention arm, low-dose thoracic computed tomography is performed for each participant in the first and the sixth years. In the control arm, chest roentgenography is performed for each participant in the first year. The participants in both arms are also encouraged to receive routine lung cancer screening using chest roentgenography annually. The interpretation of radiological findings and the follow-up of undiagnosed nodules are to be carried out according to the guidelines published in Japan. The required sample size is calculated to be 17 500 subjects for each arm.

A Randomized, Controlled Pilot Study of a Single-Session Psychoeducation Treatment for Urban, Culturally Diverse, Trauma-Exposed Adults.

PubMed

Ghafoori, Bita; Fisher, Dennis; Korosteleva, Olga; Hong, Madelyn

2016-06-01

This randomized pilot study aimed to determine whether a single session of psychoeducation improved mental health outcomes, attitudes toward treatment, and service engagement among urban, impoverished, culturally diverse, trauma-exposed adults. Sixty-seven individuals were randomly assigned to a single-session psychoeducation treatment or a delayed treatment comparison control group. The control group was found to be superior to the treatment group at posttest with respect to symptoms of posttraumatic stress disorder, anxiety, and occupational and family disability. At follow-up, all participants had completed the psychoeducation treatment, and a mixed-effects model indicated significant improvements over time in symptoms of posttraumatic stress disorder, anxiety, depression, somatization, and attitudes toward treatment. Ninety-eight percent of the participants reported the psychoeducation was helpful at follow-up. Participants also reported a 19.1% increase in mental health service utilization at follow-up compared with baseline. Implications for treatment and future research are discussed.

Vitamin E in aging persons with Down syndrome: A randomized, placebo-controlled clinical trial.

PubMed

Sano, Mary; Aisen, Paul S; Andrews, Howard F; Tsai, Wei-Yann; Lai, Florence; Dalton, Arthur J

2016-05-31

To determine whether vitamin E would slow the progression of cognitive deterioration and dementia in aging persons with Down syndrome (DS). A randomized, double-blind controlled clinical trial was conducted at 21 clinical sites, and researchers trained in research procedures recruited adults with DS older than 50 years to participate. Participants were randomly assigned to receive 1,000 IU of vitamin E orally twice daily for 3 years or identical placebo. The primary outcome was change on the Brief Praxis Test (BPT). Secondary outcomes included incident dementia and measures of clinical global change, cognition, function, and behavior. A total of 337 individuals were randomized, 168 to vitamin E and 169 to placebo. Both groups demonstrated deterioration on the BPT with no difference between drug and placebo. At baseline, 26% were diagnosed with dementia and there was an overall rate of incident dementia of 11%/year with no difference between groups. There was no effect on the secondary outcome measures. Though numerically higher in the treatment group, there was no difference in the number of adverse events (p = 0.079) and deaths (p = 0.086) between groups. Vitamin E did not slow the progression of cognitive deterioration in older individuals with DS. This study provides Class II evidence that vitamin E does not significantly slow the progression of cognitive deterioration in aging persons with DS. © 2016 American Academy of Neurology.

The effects of holistic health group interventions on improving the cognitive ability of persons with mild cognitive impairment: a randomized controlled trial

PubMed Central

Young, Kim-wan; Ng, Petrus; Kwok, Timothy; Cheng, Daphne

2017-01-01

Purpose Persons with mild cognitive impairment (PwMCI) are at a higher risk of developing dementia than those without cognitive impairment. This research study aims to evaluate the effectiveness of a holistic health group intervention, which is based on the holistic brain health approach as well as an Eastern approach to health care, on improving the cognitive ability of Chinese PwMCI. Research methods In a randomized controlled trial (RCT), 38 Chinese PwMCI were randomly assigned to either a 10-session holistic health intervention group or the control group. The holistic health treatment group attempted to promote the acceptance of their illness, enhance memory and coping skills, develop a positive lifestyle, maintain positive emotions, and facilitate emotional support among participants. The 10-session holistic health group intervention was structured, with each session conducted once per week and ~90 minutes in length. Control group patients and their family caregivers received standardized basic educational materials that provided basic information on cognitive decline for them to read at home. The Montreal Cognitive Assessment (MoCA) test was used to assess the cognitive ability of PwMCI in the pre- and posttreatment periods by a research assistant who was blind to the group assignment of the participants. Results The paired-samples t-test indicated that the treatment group (n=18) showed significant improvement in the MoCA score, whereas the control group (n=20) did not. Moreover, 2×2 (group × time) repeated-measures analysis of covariance (ANCOVA) demonstrated that the holistic health group treatment was significantly more effective than the control intervention in improving the MoCA score, with a moderate effect size, and improving the delayed recall (ie, short-term memory), with a strong effect size, after controlling for age, sex, education, and marital status. Conclusion This present RCT provides evidence to support the feasibility and effectiveness of the holistic health group intervention in improving the cognitive and short-term memory abilities of PwMCI. PMID:29026292

Efficacy of a DVD-Based Smoking Cessation Intervention for African Americans

PubMed Central

Baker, Elizabeth A.; Robinson, Robert G.

2014-01-01

Introduction: Previous research suggests that African American smokers may have improved outcomes if interventions are culturally specific. However, few interventions sufficiently address the unique needs of this population in a format with large reach potential. The purpose of this study was to test the efficacy of a newly developed digital video disc (DVD)-based cessation intervention targeting African Americans. Methods: In a 2-arm randomized trial, smokers (N = 140) were randomly assigned to view either the new Pathways to Freedom (PTF) DVD or a standard control DVD. Participants were assessed at baseline, immediately postviewing the DVD, and at a 1-month follow-up. The primary outcomes were feasibility and process variables, including intervention evaluations, readiness to quit, and risk perceptions, and smoking-related behavior changes were examined as secondary outcomes. Results: Findings demonstrated the hypothesized positive effects of the PTF DVD compared with the control DVD on content evaluations, risk perceptions, and readiness to quit at follow-up. Conclusions: We found initial evidence for the efficacy of the PTF DVD as a stand-alone intervention. Future research will test the efficacy of the DVD for smoking cessation in a larger randomized trial. The ultimate goal of this research is to validate a new intervention for an underserved community of smokers that can be used in multiple settings, such as community health clinics, primary care, quitlines, cessation clinics, and seminars/workshops. PMID:24838844

Estimating the optimal dynamic antipsychotic treatment regime: Evidence from the sequential multiple assignment randomized CATIE Schizophrenia Study

PubMed Central

Shortreed, Susan M.; Moodie, Erica E. M.

2012-01-01

Summary Treatment of schizophrenia is notoriously difficult and typically requires personalized adaption of treatment due to lack of efficacy of treatment, poor adherence, or intolerable side effects. The Clinical Antipsychotic Trials in Intervention Effectiveness (CATIE) Schizophrenia Study is a sequential multiple assignment randomized trial comparing the typical antipsychotic medication, perphenazine, to several newer atypical antipsychotics. This paper describes the marginal structural modeling method for estimating optimal dynamic treatment regimes and applies the approach to the CATIE Schizophrenia Study. Missing data and valid estimation of confidence intervals are also addressed. PMID:23087488

The effects of holistic health group interventions on improving the cognitive ability of persons with mild cognitive impairment: a randomized controlled trial.

PubMed

Young, Kim-Wan; Ng, Petrus; Kwok, Timothy; Cheng, Daphne

2017-01-01

Persons with mild cognitive impairment (PwMCI) are at a higher risk of developing dementia than those without cognitive impairment. This research study aims to evaluate the effectiveness of a holistic health group intervention, which is based on the holistic brain health approach as well as an Eastern approach to health care, on improving the cognitive ability of Chinese PwMCI. In a randomized controlled trial (RCT), 38 Chinese PwMCI were randomly assigned to either a 10-session holistic health intervention group or the control group. The holistic health treatment group attempted to promote the acceptance of their illness, enhance memory and coping skills, develop a positive lifestyle, maintain positive emotions, and facilitate emotional support among participants. The 10-session holistic health group intervention was structured, with each session conducted once per week and ~90 minutes in length. Control group patients and their family caregivers received standardized basic educational materials that provided basic information on cognitive decline for them to read at home. The Montreal Cognitive Assessment (MoCA) test was used to assess the cognitive ability of PwMCI in the pre- and posttreatment periods by a research assistant who was blind to the group assignment of the participants. The paired-samples t -test indicated that the treatment group (n=18) showed significant improvement in the MoCA score, whereas the control group (n=20) did not. Moreover, 2×2 (group × time) repeated-measures analysis of covariance (ANCOVA) demonstrated that the holistic health group treatment was significantly more effective than the control intervention in improving the MoCA score, with a moderate effect size, and improving the delayed recall (ie, short-term memory), with a strong effect size, after controlling for age, sex, education, and marital status. This present RCT provides evidence to support the feasibility and effectiveness of the holistic health group intervention in improving the cognitive and short-term memory abilities of PwMCI.

Revisiting the Quality of Reporting Randomized Controlled Trials in Nursing Literature.

PubMed

Adams, Yenupini Joyce; Kamp, Kendra; Liu, Cheng Ching; Stommel, Manfred; Thana, Kanjana; Broome, Marion E; Smith, Barbara

2018-03-01

To examine and update the literature on the quality of randomized controlled trials (RCTs) as reported in top nursing journals, based on manuscripts' adherence to the CONsolidated Standards of Reporting Trials (CONSORT) guidelines. Descriptive review of adherence of RCT manuscript to CONSORT guidelines. Top 40 International Scientific Indexing (ISI) ranked nursing journals that published 20 or more RCTs between 2010 and 2014, were included in the study. Selected articles were randomly assigned to four reviewers who assessed the quality of the articles using the CONSORT checklist. Data were analyzed using descriptive and inferential statistics. A total of 119 articles were included in the review. The mean CONSORT score significantly differed by journal but did not differ based on year of publication. The least consistently reported items included random allocation, who randomly assigned participants and whether those administering the interventions were blinded to group assignment. Although progress has been made, there is still room for improvement in the quality of RCT reporting in nursing journals. Special attention must be paid to how adequately studies adhere to the CONSORT prior to publication in nursing journals. Evidence from (RCTs) are thought to provide the best evidence for evaluating the impact of treatments and interventions by the U.S. Preventive Services Task Force. Since the evidence may be used for the development of clinical practice guidelines, it is critical that RCTs be designed, conducted, and reported appropriately and precisely. © 2017 Sigma Theta Tau International.

Intervention Fidelity: Aspects of Complementary and Alternative Medicine (CAM) Research

PubMed Central

Wyatt, Gwen; Sikorskii, Alla; Rahbar, Mohammad Hossein; Victorson, David; Adams, Lora

2010-01-01

Background The Treatment Fidelity Workgroup (TFW) established by the National Institutes of Health (NIH) provides a 5-point structure for intervention fidelity: dosing, interventionists’ consistency, intervention delivery, receipt and enactment of the intervention. Using our reflexology trial, we apply the first three points. Objectives Study objectives are to: 1) evaluate key dosage dimensions associated with CAM research; 2) evaluate approaches to interventionists’ consistency of delivery of CAM protocols; and 3) evaluate and discuss data that reflect CAM intervention fidelity. Intervention Women with late stage breast cancer (N=318) were randomly assigned to either 4 weeks of reflexology, placebo, or standard care. Results Dosing consists of three dimensions: frequency (4-sessions), duration (30 minutes), and interval between sessions (5–9 days). Interventionist consistency revealed over a 90% accuracy rate in following the protocol; 84% and 89% completion rate of the 4 session in the reflexology and placebo groups respectively; and no differences in attrition after randomization between reflexology and placebo groups (17% and 15%, respectively). Intervention delivery, examined through debriefing data, indicated a significantly higher rate of correct guesses on group assignment in the reflexology group as compared to the placebo (82% versus 46%, p-value=.0002). Conclusions This study points out the relevance of dosing, interventionists’ consistency, and delivery data within a CAM clinical trial, as well as the challenges of blinding. Implications Monitoring intervention fidelity by using the key areas identified by the BCC ensures that findings from a clinical trial are meaningful and have the potential to be translated to clinical practice. PMID:20467309

Unconditional regard buffers children's negative self-feelings.

PubMed

Brummelman, Eddie; Thomaes, Sander; Walton, Gregory M; Poorthuis, Astrid M G; Overbeek, Geertjan; Orobio de Castro, Bram; Bushman, Brad J

2014-12-01

Unconditional regard refers to the feeling that one is accepted and valued by others without conditions. Psychological theory suggests that experiences of unconditional regard lead children to feel that they are valuable despite setbacks. We hypothesized that reflecting on experiences of unconditional regard would buffer children's negative self-feelings (eg, shame, insecurity, powerlessness) in the face of setbacks. To test this hypothesis, we randomized children to reflect on experiences of unconditional regard or other experiences, and examined their response to an academic setback 3 weeks later. Participants (11-15 years old) were randomly assigned to reflect for 15 minutes on experiences of unconditional regard (n = 91), conditional regard (n = 80), or other social experiences (n = 76). Research personnel, teachers, and classmates remained blind to condition assignment. Three weeks later, after receiving their course grades, children reported their self-feelings. Course grades were obtained from school records. Receiving low course grades represents a salient and painful real-world setback for children. Replicating previous research, children who received lower grades experienced more negative self-feelings (P < .001). As predicted, this well-established relationship was significantly attenuated among children who had reflected, 3 weeks previously, on experiences of unconditional regard (Ps < .03). Reflecting on unconditional regard specifically reduced negative self-feelings after low grades (P = .01), not after average or high grades (Ps > .17). Reflecting on unconditional regard buffered children's selves against the adverse impact of an academic setback over an extended period of time. Unconditional regard may thus be an important psychological lever to reduce negative self-feelings in youth. Copyright © 2014 by the American Academy of Pediatrics.

A randomized clinical trial to test the efficacy of a family-focused, culturally informed therapy for schizophrenia.

PubMed

Weisman de Mamani, Amy; Weintraub, Marc J; Gurak, Kayla; Maura, Jessica

2014-12-01

Research strongly suggests that family interventions can benefit patients with schizophrenia, yet current interventions often fail to consider the cultural context and spiritual practices that may make them more effective and relevant to ethnic minority populations. We have developed a family focused, culturally informed treatment for schizophrenia (CIT-S) patients and their caregivers to address this gap. Sixty-nine families were randomized to either 15 sessions of CIT-S or to a 3-session psychoeducation (PSY-ED) control condition. Forty-six families (66.7%) completed the study. The primary aim was to test whether CIT-S would outperform PSY-ED in reducing posttreatment symptom severity (controlling for baseline symptoms) on the Brief Psychiatric Rating Scale. Secondary analyses were conducted to test whether treatment efficacy would be moderated by ethnicity and whether patient-therapist ethnic match would relate to efficacy and patient satisfaction with treatment. Patients included 40 Hispanic/Latinos, 14 Whites, 11 Blacks, and 4 patients who identified as "other." In line with expectations, results from an ANCOVA indicated that patients assigned to the CIT-S condition had significantly less severe psychiatric symptoms at treatment termination than did patients assigned to the PSY-ED condition. Patient ethnicity and patient-therapist ethnic match (vs. mismatch) did not relate to treatment efficacy or satisfaction with the intervention. Results suggest that schizophrenia may respond to culturally informed psychosocial interventions. The treatment appears to work equally well for Whites and minorities alike. Follow-up research with a matched length control condition is needed. Further investigation is also needed to pinpoint specific mechanisms of change.

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

PubMed

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

2017-02-01

In this study we evaluated a social skills group which employed a progressive applied behavior analysis model for individuals diagnosed with autism spectrum disorder. A randomized control trial was utilized; eight participants were randomly assigned to a treatment group and seven participants were randomly assigned to a waitlist control group. The social skills group consisted of 32, 2 h sessions. Teachers implemented a variety of behaviorally based procedures. A blind evaluator measured participants' behavior immediately prior to intervention, immediately following intervention, and during 16 and 32-week maintenance probes. Results of the study demonstrated that participants made significant improvements with their social behavior (p < .001) following intervention, and the results were maintained up to 32 weeks after intervention had concluded.

Testing a Violence-Prevention Intervention for Incarcerated Women Using a Randomized Control Trial

ERIC Educational Resources Information Center

Kubiak, Sheryl Pimlott; Kim, Woo Jong; Fedock, Gina; Bybee, Deborah

2015-01-01

Objective: Beyond Violence (BV), a new prevention program for women with assaultive offenses, demonstrated feasibility in previous studies. This study's purpose is to assess the efficacy of BV using a randomized control trial. Method: Eligible women were randomly assigned to treatment as usual (TAU) and the experimental condition (BV). Measures of…

Use of Matrix Sampling Procedures to Assess Achievement in Solving Open Addition and Subtraction Sentences.

ERIC Educational Resources Information Center

Montague, Margariete A.

This study investigated the feasibility of concurrently and randomly sampling examinees and items in order to estimate group achievement. Seven 32-item tests reflecting a 640-item universe of simple open sentences were used such that item selection (random, systematic) and assignment (random, systematic) of items (four, eight, sixteen) to forms…

Marital Status and Satisfaction Five Years Following a Randomized Clinical Trial Comparing Traditional versus Integrative Behavioral Couple Therapy

ERIC Educational Resources Information Center

Christensen, Andrew; Atkins, David C.; Baucom, Brian; Yi, Jean

2010-01-01

Objective: To follow distressed married couples for 5 years after their participation in a randomized clinical trial. Method: A total of 134 chronically and seriously distressed married couples were randomly assigned to approximately 8 months of either traditional behavioral couple therapy (TBCT; Jacobson & Margolin, 1979) or integrative…

Randomized Controlled Trial of the Resilience and Coping Intervention (RCI) with Undergraduate University Students

ERIC Educational Resources Information Center

Houston, J. Brian; First, Jennifer; Spialek, Matthew L.; Sorenson, Mary E.; Mills-Sandoval, Toby; Lockett, McKenzie; First, Nathan L.; Nitiéma, Pascal; Allen, Sandra F.; Pfefferbaum, Betty

2017-01-01

Objective: The purpose of this pilot study was to evaluate the Resilience and Coping Intervention (RCI) with college students. Participants: College students (aged 18-23) from a large Midwest US university who volunteered for a randomized controlled trial during the 2015 spring semester. Methods: College students were randomly assigned to an…

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

ERIC Educational Resources Information Center

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

2011-01-01

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

A Randomized Controlled Study of the Virginia Student Threat Assessment Guidelines in Kindergarten through Grade 12

ERIC Educational Resources Information Center

Cornell, Dewey G.; Allen, Korrie; Fan, Xitao

2012-01-01

This randomized controlled study examined disciplinary outcomes for 201 students who made threats of violence at school. The students attended 40 schools randomly assigned to use the Virginia Student Threat Assessment Guidelines or follow a business-as-usual disciplinary approach in a control group. Logistic regression analyses found, after…

Improving Generalizations from Experiments Using Propensity Score Subclassification: Assumptions, Properties, and Contexts

ERIC Educational Resources Information Center

Tipton, Elizabeth

2013-01-01

As a result of the use of random assignment to treatment, randomized experiments typically have high internal validity. However, units are very rarely randomly selected from a well-defined population of interest into an experiment; this results in low external validity. Under nonrandom sampling, this means that the estimate of the sample average…

Effect of Educational Package on Lifestyle of Primiparous Mothers during Postpartum Period: A Randomized Controlled Clinical Trial

ERIC Educational Resources Information Center

Khodabandeh, Farzaneh; Mirghafourvand, Mojgan; KamaliFard, Mahin; Mohammad-Alizadeh-Charandabi, Sakineh; Asghari Jafarabadi, Mohammad

2017-01-01

A healthy lifestyle is important for mothers during the postpartum period. This study was conducted to determine the effects of a lifestyle educational package in primiparous women. This randomized clinical trial was conducted on 220 mothers assigned to two groups using block randomization. In the intervention group, the mothers received…

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…

Impact of Patient Education on Influenza Vaccine Uptake among Community-Dwelling Elderly: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Leung, Ka Chun; Mui, Carlo; Chiu, Wing Yan; Ng, Yuk Yiu; Chen, Matthew H. Y.; Ho, Pui Hung; Kwok, Chun Pong; Lam, Suki S. M.; Wong, Chun Yip; Wong, Kit Yee; Pang, Herbert H.

2017-01-01

This randomized controlled trial aimed to test the effectiveness of brief face-to-face patient education in increasing influenza vaccination rate among elderly in the community. Recruitment and intervention were conducted at two general outpatient clinics in Hong Kong. 529 eligible patients were randomly assigned to intervention or control group…

Child Health and Neighborhood Conditions: Results from a Randomized Housing Voucher Experiment

ERIC Educational Resources Information Center

Fortson, Jane G.; Sanbonmatsu, Lisa

2010-01-01

Using data from the Moving to Opportunity randomized housing voucher experiment, we estimate the direct effects of housing and neighborhood quality on child health. We show that, five years after random assignment, housing mobility has little impact on overall health status, asthma, injuries, and body mass index. The few effects that we observe…

Improving Young English Learners' Language and Literacy Skills through Teacher Professional Development: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Babinski, Leslie M.; Amendum, Steven J.; Knotek, Steven E.; Sánchez, Marta; Malone, Patrick

2018-01-01

Using a randomized controlled trial, we tested a new teacher professional development program for increasing the language and literacy skills of young Latino English learners with 45 teachers and 105 students in 12 elementary schools. School-based teams randomly assigned to the intervention received professional development focused on cultural…

Improving Classroom Learning Environments by Cultivating Awareness and Resilience in Education (CARE): Results of a Randomized Controlled Trial

ERIC Educational Resources Information Center

Jennings, Patricia A.; Frank, Jennifer L.; Snowberg, Karin E.; Coccia, Michael A.; Greenberg, Mark T.

2013-01-01

Cultivating Awareness and Resilience in Education (CARE for Teachers) is a mindfulness-based professional development program designed to reduce stress and improve teachers' performance and classroom learning environments. A randomized controlled trial examined program efficacy and acceptability among a sample of 50 teachers randomly assigned to…

Part versus Whole: A Randomized Trial of Central Venous Catheterization Education

ERIC Educational Resources Information Center

Chan, Angela; Singh, Sunita; Dubrowski, Adam; Pratt, Daniel D.; Zalunardo, Nadia; Nair, Parvarthy; McLaughlin, Kevin; Ma, Irene W. Y.

2015-01-01

Central venous catheterization (CVC) is a complex but commonly performed procedure. How best to teach this complex skill has not been clearly delineated. We conducted a randomized trial of the effects of two types of teaching of CVC on skill acquisition and retention. We randomly assigned novice internal medicine residents to learning CVC in-part…

A Randomized Controlled Trial of a Standardized Behavior Management Intervention for Students with Externalizing Behavior

ERIC Educational Resources Information Center

Forster, Martin; Sundell, Knut; Morris, Richard J.; Karlberg, Martin; Melin, Lennart

2012-01-01

This study reports the results from a Swedish randomized controlled trial of a standardized behavior management intervention. The intervention targeted students with externalizing behavior in a regular education setting. First- and second-grade students (N = 100) from 38 schools were randomly assigned to either the intervention or an active…

The Effects of Team-Based Learning on Social Studies Knowledge Acquisition in High School

ERIC Educational Resources Information Center

Wanzek, Jeanne; Vaughn, Sharon; Kent, Shawn C.; Swanson, Elizabeth A.; Roberts, Greg; Haynes, Martha; Fall, Anna-Mária; Stillman-Spisak, Stephanie J.; Solis, Michael

2014-01-01

This randomized control trial examined the efficacy of team-based learning implemented within 11th-grade social studies classes. A randomized blocked design was implemented with 26 classes randomly assigned to treatment or comparison. In the treatment classes teachers implemented team-based learning practices to support students in engaging in…

Ways of Research: The Status of the Traditional Research Paper Assignment in First-Year Writing/Composition Courses

ERIC Educational Resources Information Center

Hood, Carra Leah

2010-01-01

I created my Exploratory Survey on the Status of the Research Paper Assignment in First-year Writing/Composition Courses to learn whether the traditional research paper remained as common an assignment in 2009 as it had been in the past. My survey updates results from two previous surveys on the status of this assignment. Ambrose N. Manning's…

Effects of feedback-based balance and core resistance training vs. Pilates training on cognitive functions in older women with mild cognitive impairment: a pilot randomized controlled trial.

PubMed

Greblo Jurakic, Zrinka; Krizanic, Valerija; Sarabon, Nejc; Markovic, Goran

2017-12-01

There is limited research about beneficial effects of physical activity in older adults suffering from mild cognitive impairment (MCI). The aim of the study was to provide preliminary evidence on the effects of two types of non-aerobic training on cognitive functions in older women suffering from MCI. Twenty-eight participants aged 66-78 years with MCI were randomly assigned to a combined balance and core resistance training group (n = 14) or to a Pilates group (n = 14). Following completion of the 8-week exercise programme, both groups showed significant improvements in global and specific cognitive domains. Findings suggest that non-aerobic training should be further explored as a beneficial intervention for older adults suffering from MCI.

In vivo social comparison to a thin-ideal peer promotes body dissatisfaction: a randomized experiment.

PubMed

Krones, Pamela G; Stice, Eric; Batres, Carla; Orjada, Kendra

2005-09-01

Although social comparison with media-portrayed thin-ideal images has been found to increase body dissatisfaction and negative affect, research has not yet tested whether social comparison with attractive peers in the real world produces similar effects. We randomly assigned 119 young women to interact either with a confederate who conformed to the thin ideal or one who conformed to the average body dimensions of women, within the context of an ostensive dating study. Exposure to the thin-ideal confederate resulted in an increase in body dissatisfaction but not negative affect or heart rate. Initial thin-ideal internalization, perceived sociocultural pressure, self-esteem, and observer-rated attractiveness did not moderate these effects. Results suggest that social comparative pressure to be thin fosters body dissatisfaction but may not promote negative affect. 2005 by Wiley Periodicals, Inc.

German adjuvant intergroup node-positive study: a phase III trial to compare oral ibandronate versus observation in patients with high-risk early breast cancer.

PubMed

von Minckwitz, Gunter; Möbus, Volker; Schneeweiss, Andreas; Huober, Jens; Thomssen, Christoph; Untch, Michael; Jackisch, Christian; Diel, Ingo J; Elling, Dirk; Conrad, Bettina; Kreienberg, Rolf; Müller, Volkmar; Lück, Hans-Joachim; Bauerfeind, Ingo; Clemens, Michael; Schmidt, Marcus; Noeding, Stefanie; Forstbauer, Helmut; Barinoff, Jana; Belau, Antje; Nekljudova, Valentina; Harbeck, Nadia; Loibl, Sibylle

2013-10-01

Bisphosphonates prevent skeletal-related events in patients with metastatic breast cancer. Their effect in early breast cancer is controversial. Ibandronate is an orally and intravenously available amino-bisphosphonate with a favorable toxicity profile. It therefore qualifies as potential agent for adjuvant use. The GAIN (German Adjuvant Intergroup Node-Positive) study was an open-label, randomized, controlled phase III trial with a 2 × 2 factorial design. Patients with node-positive early breast cancer were randomly assigned 1:1 to two different dose-dense chemotherapy regimens and 2:1 to ibandronate 50 mg per day orally for 2 years or observation. In all, 2,640 patients and 728 events were estimated to be required to demonstrate an increase in disease-free survival (DFS) by ibandronate from 75% to 79.5% by using a two-sided α = .05 and 1-β of 80%. We report here the efficacy analysis for ibandronate, which was released by the independent data monitoring committee because the futility boundary was not crossed after 50% of the required DFS events were observed. Between June 2004 and August 2008, 2,015 patients were randomly assigned to ibandronate and 1,008 to observation. Patients randomly assigned to ibandronate showed no superior DFS or overall survival (OS) compared with patients randomly assigned to observation (DFS: hazard ratio, 0.945; 95% CI, 0.768 to 1.161; P = .589; OS: HR, 1.040; 95% CI, 0.763 to 1.419; P = .803). DFS was numerically longer if ibandronate was used in patients younger than 40 years or older than 60 years compared with patients age 40 to 59 years (test for interaction P = .093). Adjuvant treatment with oral ibandronate did not improve outcome of patients with high-risk early breast cancer who received dose-dense chemotherapy.

Everolimus for the Treatment of Advanced Pancreatic Neuroendocrine Tumors: Overall Survival and Circulating Biomarkers From the Randomized, Phase III RADIANT-3 Study.

PubMed

Yao, James C; Pavel, Marianne; Lombard-Bohas, Catherine; Van Cutsem, Eric; Voi, Maurizio; Brandt, Ulrike; He, Wei; Chen, David; Capdevila, Jaume; de Vries, Elisabeth G E; Tomassetti, Paola; Hobday, Timothy; Pommier, Rodney; Öberg, Kjell

2016-11-10

Purpose Everolimus improved median progression-free survival by 6.4 months in patients with advanced pancreatic neuroendocrine tumors (NET) compared with placebo in the RADIANT-3 study. Here, we present the final overall survival (OS) data and data on the impact of biomarkers on OS from the RADIANT-3 study. Methods Patients with advanced, progressive, low- or intermediate-grade pancreatic NET were randomly assigned to everolimus 10 mg/day (n = 207) or placebo (n = 203). Crossover from placebo to open-label everolimus was allowed on disease progression. Ongoing patients were unblinded after final progression-free survival analysis and could transition to open-label everolimus at the investigator's discretion (extension phase). OS analysis was performed using a stratified log-rank test in the intent-to-treat population. The baseline levels of chromogranin A, neuron-specific enolase, and multiple soluble angiogenic biomarkers were determined and their impact on OS was explored. Results Of 410 patients who were enrolled between July 2007 and March 2014, 225 received open-label everolimus, including 172 patients (85%) randomly assigned initially to the placebo arm. Median OS was 44.0 months (95% CI, 35.6 to 51.8 months) for those randomly assigned to everolimus and 37.7 months (95% CI, 29.1 to 45.8 months) for those randomly assigned to placebo (hazard ratio, 0.94; 95% CI, 0.73 to 1.20; P = .30). Elevated baseline chromogranin A, neuron-specific enolase, placental growth factor, and soluble vascular endothelial growth factor receptor 1 levels were poor prognostic factors for OS. The most common adverse events included stomatitis, rash, and diarrhea. Conclusion Everolimus was associated with a median OS of 44 months in patients with advanced, progressive pancreatic NET, the longest OS reported in a phase III study for this population. Everolimus was associated with a survival benefit of 6.3 months, although this finding was not statistically significant. Crossover of patients likely confounded the OS results.

Regulatory Focus Affects Physician Risk Tolerance

PubMed Central

Veazie, Peter J.; McIntosh, Scott; Chapman, Benjamin P.; Dolan, James G.

2014-01-01

Risk tolerance is a source of variation in physician decision-making. This variation, if independent of clinical concerns, can result in mistaken utilization of health services. To address such problems, it will be helpful to identify nonclinical factors of risk tolerance, particularly those amendable to intervention – regulatory focus theory suggests such a factor. This study tested whether regulatory focus affects risk tolerance among primary care physicians. Twenty-seven primary care physicians were assigned to promotion-focused or prevention-focused manipulations and compared on the Risk Taking Attitudes in Medical Decision Making scale using a randomization test. Results provide evidence that physicians assigned to the promotion-focus manipulation adopted an attitude of greater risk tolerance than the physicians assigned to the prevention-focused manipulation (P=0.01). The Cohen’s d statistic was conventionally large at 0.92. Results imply that situational regulatory focus in primary care physicians affects risk tolerance and may thereby be a nonclinical source of practice variation. Results also provide marginal evidence that chronic regulatory focus is associated with risk tolerance (P=0.05), but the mechanism remains unclear. Research and intervention targeting physician risk tolerance may benefit by considering situational regulatory focus as an explanatory factor. PMID:25431799

Effects of approach and services under differential response on long term child safety and welfare.

PubMed

Loman, L Anthony; Siegel, Gary L

2015-01-01

An outcome analysis was conducted based on an extended follow-up of the implementation of differential response program reforms in Child Protective Services offices in 10 counties in a Midwestern U.S. State. Random assignment was conducted of families that were first determined to be appropriate for family assessments. Experimental families (n=2,382) were each assigned to a non-forensic family assessment, and control families (n=2,247) each received a forensic investigation. Families were assigned continuously over a 15-month period and then tracked from 45 to 60 months from the date of assignment. Detailed information on services provided and family responses was obtained via two subsamples of experimental and control families. Measures of family engagement and service reception and utilization were utilized to determine instrumental outcomes introduced through family assessments. Improved family engagement and increased and broadened services were found to have occurred, and it was theorized that these changes mediated extended outcomes. Extended outcomes included reductions of rates of subsequent screened-in reports of child maltreatment, proportions of families that experienced child removals, and instances of new safety threats and problems in parenting. Differences in outcomes were found among the participating counties with 4 counties accounting for most outcome differences. The relationships between instrumental and extended outcomes were discussed with suggestions for further research. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

Acute changes of hip joint range of motion using selected clinical stretching procedures: A randomized crossover study.

PubMed

Hammer, Adam M; Hammer, Roger L; Lomond, Karen V; O'Connor, Paul

2017-12-01

Hip adductor flexibility and strength is an important component of athletic performance and many activities of daily living. Little research has been done on the acute effects of a single session of stretching on hip abduction range of motion (ROM). The aim of this study was to compare 3 clinical stretching procedures against passive static stretching and control on ROM and peak isometric maximal voluntary contraction (MVC). Using a randomized crossover study design, a total of 40 participants (20 male and 20 female) who had reduced hip adductor muscle length attended a familiarization session and 5 testing sessions on non-consecutive days. Following the warm-up and pre-intervention measures of ROM and MVC, participants were randomly assigned 1 of 3 clinical stretching procedures (modified lunge, multidirectional, and joint mobilization) or a static stretch or control condition. Post-intervention measures of ROM and MVC were taken immediately following completion of the assigned condition. An ANOVA using a repeated measure design with the change score was conducted. All interventions resulted in small but statistically significant (p < 0.05) increases (1.0°-1.7°) in ROM with no inter-condition differences except one. Multidirectional stretching was greater than control (p = 0.031). These data suggest that a single session of stretching has only a minimal effect on acute changes of hip abduction ROM. Although hip abduction is a frontal plane motion, to effectively increase the extensibility of the structures that limit abduction, integrating multi-planar stretches may be indicated. Copyright © 2017 Elsevier Ltd. All rights reserved.

Receipt of Preventive Services After Oregon's Randomized Medicaid Experiment.

PubMed

Marino, Miguel; Bailey, Steffani R; Gold, Rachel; Hoopes, Megan J; O'Malley, Jean P; Huguet, Nathalie; Heintzman, John; Gallia, Charles; McConnell, K John; DeVoe, Jennifer E

2016-02-01

It is predicted that gaining health insurance via the Affordable Care Act will result in increased rates of preventive health services receipt in the U.S., primarily based on self-reported findings from previous health insurance expansion studies. This study examined the long-term (36-month) impact of Oregon's 2008 randomized Medicaid expansion ("Oregon Experiment") on receipt of 12 preventive care services in community health centers using electronic health record data. Demographic data from adult (aged 19-64 years) Oregon Experiment participants were probabilistically matched to electronic health record data from 49 Oregon community health centers within the OCHIN community health information network (N=10,643). Intent-to-treat analyses compared receipt of preventive services over a 36-month (2008-2011) period among those randomly assigned to apply for Medicaid versus not assigned, and instrumental variable analyses estimated the effect of actually gaining Medicaid coverage on preventive services receipt (data collected in 2012-2014; analysis performed in 2014-2015). Intent-to-treat analyses revealed statistically significant differences between patients randomly assigned to apply for Medicaid (versus not assigned) for 8 of 12 assessed preventive services. In intent-to-treat analyses, Medicaid coverage significantly increased the odds of receipt of most preventive services (ORs ranging from 1.04 [95% CI=1.02, 1.06] for smoking assessment to 1.27 [95% CI=1.02, 1.57] for mammography). Rates of preventive services receipt will likely increase as community health center patients gain insurance through Affordable Care Act expansions. Continued effort is needed to increase health insurance coverage in an effort to decrease health disparities in vulnerable populations. Copyright © 2016 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Receipt of Preventive Services After Oregon’s Randomized Medicaid Experiment

PubMed Central

Marino, Miguel; Bailey, Steffani R.; Gold, Rachel; Hoopes, Megan J.; O’Malley, Jean P.; Huguet, Nathalie; Heintzman, John; Gallia, Charles; McConnell, K. John; DeVoe, Jennifer E.

2015-01-01

Introduction It is predicted that gaining health insurance via the Affordable Care Act will result in increased rates of preventive health services receipt in the U.S, primarily based on self-reported findings from previous health insurance expansion studies. This study examined the long-term (36-month) impact of Oregon’s 2008 randomized Medicaid expansion (“Oregon Experiment”) on receipt of 12 preventive care services in community health centers using electronic health record data. Methods Demographic data from adult (aged 19–64 years) Oregon Experiment participants were probabilistically matched to electronic health record data from 49 Oregon community health centers within the OCHIN community health information network (N=10,643). Intent-to-treat analyses compared receipt of preventive services over a 36-month (2008–2011) period among those randomly assigned to apply for Medicaid versus not assigned, and instrumental variable analyses estimated the effect of actually gaining Medicaid coverage on preventive services receipt (data collected in 2012–2014; analysis performed in 2014–2015). Results Intent-to-treat analyses revealed statistically significant differences between patients randomly assigned to apply for Medicaid (versus not assigned) for eight of 12 assessed preventive services. In intent-to-treat[MM1] analyses, Medicaid coverage significantly increased the odds of receipt of most preventive services (ORs ranging from 1.04 [95% CI=1.02, 1.06] for smoking assessment to 1.27 [95% CI=1.02, 1.57] for mammography). Conclusions Rates of preventive services receipt will likely increase as community health center patients gain insurance through Affordable Care Act expansions. Continued effort is needed to increase health insurance coverage in an effort to decrease health disparities in vulnerable populations. PMID:26497264

Emotional Disclosure through Writing or Speaking Modulates Latent Epstein-Barr Virus Antibody Titers.

ERIC Educational Resources Information Center

Esterling, Brian A.; And Others

1994-01-01

Healthy Epstein-Barr virus (EBV) seropositive undergraduates (n=57) completed personality inventory, provided blood samples, and were randomly assigned to write/talk about stressful events, or to write about trivial events. Those assigned to verbal/stressful condition had significantly lower EBV antibody titers (suggesting better cellular immune…

Group Versus Individual Counseling: A Junior College Study. Final Report.

ERIC Educational Resources Information Center

Aughinbaugh, Lorine A.

Increases in junior college enrollment, coupled with a shortage of qualified guidance personnel, have forced many colleges to rely more heavily on group than on individual counseling for students. In the fall of 1965, students entering American River College were randomly assigned to either group or individual sessions, or not assigned, and these…

40 CFR 798.5395 - In vivo mammalian bone marrow cytogenetics tests: Micronucleus assay.

Code of Federal Regulations, 2011 CFR

2011-07-01

... five female and five male animals per experimental and control group shall be used. Thus, 10 animals...) Assignment to groups. Animals shall be randomized and assigned to treatment and control groups. (4) Control groups—(i) Concurrent controls. Concurrent positive and negative (vehicle) controls shall be included in...

40 CFR 798.5395 - In vivo mammalian bone marrow cytogenetics tests: Micronucleus assay.

Code of Federal Regulations, 2012 CFR

2012-07-01

... five female and five male animals per experimental and control group shall be used. Thus, 10 animals...) Assignment to groups. Animals shall be randomized and assigned to treatment and control groups. (4) Control groups—(i) Concurrent controls. Concurrent positive and negative (vehicle) controls shall be included in...

40 CFR 798.5395 - In vivo mammalian bone marrow cytogenetics tests: Micronucleus assay.

Code of Federal Regulations, 2014 CFR

2014-07-01

... five female and five male animals per experimental and control group shall be used. Thus, 10 animals...) Assignment to groups. Animals shall be randomized and assigned to treatment and control groups. (4) Control groups—(i) Concurrent controls. Concurrent positive and negative (vehicle) controls shall be included in...

40 CFR 798.5395 - In vivo mammalian bone marrow cytogenetics tests: Micronucleus assay.

Code of Federal Regulations, 2010 CFR

2010-07-01

... five female and five male animals per experimental and control group shall be used. Thus, 10 animals...) Assignment to groups. Animals shall be randomized and assigned to treatment and control groups. (4) Control groups—(i) Concurrent controls. Concurrent positive and negative (vehicle) controls shall be included in...

40 CFR 798.5395 - In vivo mammalian bone marrow cytogenetics tests: Micronucleus assay.

Code of Federal Regulations, 2013 CFR

2013-07-01

... five female and five male animals per experimental and control group shall be used. Thus, 10 animals...) Assignment to groups. Animals shall be randomized and assigned to treatment and control groups. (4) Control groups—(i) Concurrent controls. Concurrent positive and negative (vehicle) controls shall be included in...

The Role of Perpetrator Motivation in Two Crime Scenarios

ERIC Educational Resources Information Center

Sizemore, O. J.

2013-01-01

Undergraduate volunteers (n = 134) were randomly assigned in a 2 x 2 design that manipulated type of crime (rape vs. robbery) and perpetrator motivation (anger vs. desire). After reading one of the crime scenarios, participants responded to a series of attitude items regarding responsibility for the crime, assigned blame to agents mentioned in the…

Randomized Trial of Reduced-Nicotine Standards for Cigarettes.

PubMed

Donny, Eric C; Denlinger, Rachel L; Tidey, Jennifer W; Koopmeiners, Joseph S; Benowitz, Neal L; Vandrey, Ryan G; al'Absi, Mustafa; Carmella, Steven G; Cinciripini, Paul M; Dermody, Sarah S; Drobes, David J; Hecht, Stephen S; Jensen, Joni; Lane, Tonya; Le, Chap T; McClernon, F Joseph; Montoya, Ivan D; Murphy, Sharon E; Robinson, Jason D; Stitzer, Maxine L; Strasser, Andrew A; Tindle, Hilary; Hatsukami, Dorothy K

2015-10-01

The Food and Drug Administration can set standards that reduce the nicotine content of cigarettes. We conducted a double-blind, parallel, randomized clinical trial between June 2013 and July 2014 at 10 sites. Eligibility criteria included an age of 18 years or older, smoking of five or more cigarettes per day, and no current interest in quitting smoking. Participants were randomly assigned to smoke for 6 weeks either their usual brand of cigarettes or one of six types of investigational cigarettes, provided free. The investigational cigarettes had nicotine content ranging from 15.8 mg per gram of tobacco (typical of commercial brands) to 0.4 mg per gram. The primary outcome was the number of cigarettes smoked per day during week 6. A total of 840 participants underwent randomization, and 780 completed the 6-week study. During week 6, the average number of cigarettes smoked per day was lower for participants randomly assigned to cigarettes containing 2.4, 1.3, or 0.4 mg of nicotine per gram of tobacco (16.5, 16.3, and 14.9 cigarettes, respectively) than for participants randomly assigned to their usual brand or to cigarettes containing 15.8 mg per gram (22.2 and 21.3 cigarettes, respectively; P<0.001). Participants assigned to cigarettes with 5.2 mg per gram smoked an average of 20.8 cigarettes per day, which did not differ significantly from the average number among those who smoked control cigarettes. Cigarettes with lower nicotine content, as compared with control cigarettes, reduced exposure to and dependence on nicotine, as well as craving during abstinence from smoking, without significantly increasing the expired carbon monoxide level or total puff volume, suggesting minimal compensation. Adverse events were generally mild and similar among groups. In this 6-week study, reduced-nicotine cigarettes versus standard-nicotine cigarettes reduced nicotine exposure and dependence and the number of cigarettes smoked. (Funded by the National Institute on Drug Abuse and the Food and Drug Administration Center for Tobacco Products; ClinicalTrials.gov number, NCT01681875.).

Evaluating a Web-Based Social Anxiety Intervention Among University Students: Randomized Controlled Trial.

PubMed

McCall, Hugh Cameron; Richardson, Chris G; Helgadottir, Fjola Dogg; Chen, Frances S

2018-03-21

Treatment rates for social anxiety, a prevalent and potentially debilitating condition, remain among the lowest of all major mental disorders today. Although computer-delivered interventions are well poised to surmount key barriers to the treatment of social anxiety, most are only marginally effective when delivered as stand-alone treatments. A new, Web-based cognitive behavioral therapy (CBT) intervention called Overcome Social Anxiety was recently created to address the limitations of prior computer-delivered interventions. Users of Overcome Social Anxiety are self-directed through various CBT modules incorporating cognitive restructuring and behavioral experiments. The intervention is personalized to each user's symptoms, and automatic email reminders and time limits are used to encourage adherence. The purpose of this study was to conduct a randomized controlled trial to investigate the effectiveness of Overcome Social Anxiety in reducing social anxiety symptoms in a nonclinical sample of university students. As a secondary aim, we also investigated whether Overcome Social Anxiety would increase life satisfaction in this sample. Following eligibility screening, participants were randomly assigned to a treatment condition or a wait-list control condition. Only those assigned to the treatment condition were given access to Overcome Social Anxiety; they were asked to complete the program within 4 months. The social interaction anxiety scale (SIAS), the fear of negative evaluation scale (FNE), and the quality of life enjoyment and satisfaction questionnaire-short form (Q-LES-Q-SF) were administered to participants from both conditions during baseline and 4-month follow-up lab visits. Over the course of the study, participants assigned to the treatment condition experienced a significant reduction in social anxiety (SIAS: P<.001, Cohen d=0.72; FNE: P<.001, Cohen d=0.82), whereas those assigned to the control condition did not (SIAS: P=.13, Cohen d=0.26; FNE: P=.40, Cohen d=0.14). Additionally, a direct comparison of the average change in social anxiety in the 2 conditions over the course of the study showed that those assigned to the treatment condition experienced significantly more improvement than those assigned to the control condition (SIAS: P=.03, Cohen d=0.56; FNE: P=.001, Cohen d=0.97). Although participants assigned to the treatment condition experienced a slight increase in life satisfaction, as measured by Q-LES-Q-SF scores, and those assigned to the control condition experienced a slight decrease, these changes were not statistically significant (treatment: P=.35, Cohen d=-0.18; control: P=.30, Cohen d=0.18). Our findings indicate that Overcome Social Anxiety is an effective intervention for treating symptoms of social anxiety and that it may have further utility in serving as a model for the development of new interventions. Additionally, our findings provide evidence that contemporary Web-based interventions can be sophisticated enough to benefit users even when delivered as stand-alone treatments, suggesting that further opportunities likely exist for the development of other Web-based mental health interventions. ClinicalTrials.gov NCT02792127; https://clinicaltrials.gov/ct2/show/record/NCT02792127 (Archived by WebCite at http://www.webcitation.org/6xGSRh7MG). ©Hugh Cameron McCall, Chris G Richardson, Fjola Dogg Helgadottir, Frances S Chen. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 21.03.2018.

Constructing cardiovascular fitness knowledge in physical education

PubMed Central

Zhang, Tan; Chen, Ang; Chen, Senlin; Hong, Deockki; Loflin, Jerry; Ennis, Catherine

2015-01-01

In physical education, it has become necessary for children to learn kinesiological knowledge for understanding the benefits of physical activity and developing a physically active lifestyle. This study was conducted to determine the extent to which cognitive assignments about healthful living and fitness contributed to knowledge growth on cardiorespiratory fitness and health. Fourth grade students (N = 616) from 15 randomly sampled urban elementary schools completed 34 cognitive assignments related to the cardiorespiratory physical activities they were engaged in across 10 lessons. Performance on the assignments were analyzed in relation to their knowledge gain measured using a standardized knowledge test. A multivariate discriminant analysis revealed that the cognitive assignments contributed to knowledge gain but the contribution varied assignment by assignment. A multiple regression analysis indicated that students’ assignment performance by lesson contributed positively to their knowledge growth scores. A content analysis based on the constructivist learning framework showed that observing–reasoning assignments contributed the most to knowledge growth. Analytical and analytical–application assignments contributed less than the constructivist theories would predict. PMID:25995702

A registry-based randomized trial comparing radial and femoral approaches in women undergoing percutaneous coronary intervention: the SAFE-PCI for Women (Study of Access Site for Enhancement of PCI for Women) trial.

PubMed

Rao, Sunil V; Hess, Connie N; Barham, Britt; Aberle, Laura H; Anstrom, Kevin J; Patel, Tejan B; Jorgensen, Jesse P; Mazzaferri, Ernest L; Jolly, Sanjit S; Jacobs, Alice; Newby, L Kristin; Gibson, C Michael; Kong, David F; Mehran, Roxana; Waksman, Ron; Gilchrist, Ian C; McCourt, Brian J; Messenger, John C; Peterson, Eric D; Harrington, Robert A; Krucoff, Mitchell W

2014-08-01

This study sought to determine the effect of radial access on outcomes in women undergoing percutaneous coronary intervention (PCI) using a registry-based randomized trial. Women are at increased risk of bleeding and vascular complications after PCI. The role of radial access in women is unclear. Women undergoing cardiac catheterization or PCI were randomized to radial or femoral arterial access. Data from the CathPCI Registry and trial-specific data were merged into a final study database. The primary efficacy endpoint was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding or vascular complications requiring intervention. The primary feasibility endpoint was access site crossover. The primary analysis cohort was the subgroup undergoing PCI; sensitivity analyses were conducted in the total randomized population. The trial was stopped early for a lower than expected event rate. A total of 1,787 women (691 undergoing PCI) were randomized at 60 sites. There was no significant difference in the primary efficacy endpoint between radial or femoral access among women undergoing PCI (radial 1.2% vs. 2.9% femoral, odds ratio [OR]: 0.39; 95% confidence interval [CI]: 0.12 to 1.27); among women undergoing cardiac catheterization or PCI, radial access significantly reduced bleeding and vascular complications (0.6% vs. 1.7%; OR: 0.32; 95% CI: 0.12 to 0.90). Access site crossover was significantly higher among women assigned to radial access (PCI cohort: 6.1% vs. 1.7%; OR: 3.65; 95% CI: 1.45 to 9.17); total randomized cohort: (6.7% vs. 1.9%; OR: 3.70; 95% CI: 2.14 to 6.40). More women preferred radial access. In this pragmatic trial, which was terminated early, the radial approach did not significantly reduce bleeding or vascular complications in women undergoing PCI. Access site crossover occurred more often in women assigned to radial access. (SAFE-PCI for Women; NCT01406236). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

An assessment of health behavior peer effects in Peking University dormitories: a randomized cluster-assignment design for interference.

PubMed

Yuan, Changzheng; Lv, Jun; VanderWeele, Tyler J

2013-01-01

Relatively little is known about the peer influence in health behaviors within university dormitory rooms. Moreover, in China, the problem of unhealthy behaviors among university students has not yet been sufficiently recognized. We thus investigated health behavior peer influence in Peking University dormitories utilizing a randomized cluster-assignment design. Cross-sectional in-dormitory survey. Current students from Peking University Health Science Center from April to June, 2009. Self-reported questionnaire on health behaviors: physical activity (including bicycling), dietary intake and tobacco use. Use of bicycle, moderate-intensity exercise, frequency of sweet food and soybean milk intake, frequency of roasted/baked/toasted food intake were behaviors significantly or marginally significantly affected by peer influence. Health behavior peer effects exist within dormitory rooms among university students. This could provide guidance on room assignment, or inform intervention programs. Examining these may demand attention from university administrators and policy makers.

Agriculture, nutrition, and health in global development: typology and metrics for integrated interventions and research.

PubMed

Masters, William A; Webb, Patrick; Griffiths, Jeffrey K; Deckelbaum, Richard J

2014-12-01

Despite rhetoric arguing that enhanced agriculture leads to improved nutrition and health, there is scant empirical evidence about potential synergies across sectors or about the mix of actions that best supports all three sectors. The geographic scale and socioeconomic nature of these interventions require integration of previously separate research methods. This paper proposes a typology of interventions and a metric of integration among them to help researchers build on each other's results, facilitating integration in methods to inform the design of multisector interventions. The typology recognizes the importance of regional effect modifiers that are not themselves subject to randomized assignment, and trade-offs in how policies and programs are implemented, evaluated, and scaled. Using this typology could facilitate methodological pluralism, helping researchers in one field use knowledge generated elsewhere, each using the most appropriate method for their situation. © 2014 New York Academy of Sciences.

Data-Division-Specific Robustness and Power of Randomization Tests for ABAB Designs

ERIC Educational Resources Information Center

Manolov, Rumen; Solanas, Antonio; Bulte, Isis; Onghena, Patrick

2010-01-01

This study deals with the statistical properties of a randomization test applied to an ABAB design in cases where the desirable random assignment of the points of change in phase is not possible. To obtain information about each possible data division, the authors carried out a conditional Monte Carlo simulation with 100,000 samples for each…