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.

76 FR 74076 - Notice of Random Assignment Study To Evaluate the YouthBuild Program; Final Notice

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-30

... Evaluate the YouthBuild Program; Final Notice AGENCY: Employment and Training Administration (ETA), Labor... rigorous, nationally-representative estimates of the net impacts of the YouthBuild program. The Department... study. In the sites randomly selected to participate in this evaluation, all applicants for YouthBuild...

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.

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...

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

ERIC Educational Resources Information Center

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

2015-01-01

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

Assessing the Promise of Standards-Based Performance Evaluation for Principals: Results from a Randomized Trial

ERIC Educational Resources Information Center

Kimball, Steven Miller; Milanowski, Anthony; McKinney, Sarah A.

2009-01-01

Principals (N = 76) in a large western U.S. school district were randomly assigned to be evaluated using either a new standards-based system or to continue with the old system. It was hypothesized that principals evaluated with the new system would report clearer performance expectations, better feedback, greater fairness and system satisfaction,…

Promoting Social Skill Development in Children with Pervasive Developmental Disorders: A Feasibility and Efficacy Study

ERIC Educational Resources Information Center

Koenig, Kathleen; White, Susan Williams; Pachler, Maryellen; Lau, Monika; Lewis, Moira; Klin, Ami; Scahill, Lawrence

2010-01-01

A randomized controlled design was employed to evaluate a social skills intervention for children with pervasive developmental disorders. Aims included evaluating the acceptability of the program and gathering preliminary evidence on efficacy. Forty-four children, ages 8-11 years, were randomly assigned to treatment or wait list. Treatment…

Georgia's Pre-K Professional Development Evaluation: Technical Appendix. Publication #2015-02B

ERIC Educational Resources Information Center

Early, Diane M.; Pan, Yi; Maxwell, Kelly L.

2014-01-01

The primary purpose of the accompanying final study was to evaluate the impact of two professional development models on teacher-child interactions in Georgia's Pre-K classrooms. Teachers were randomly selected to participate and were randomly assigned to one of the professional development conditions or to a control group. Because of this…

An Evaluation of Second Step: What Are the Benefits for Youth With and Without Disabilities?

ERIC Educational Resources Information Center

Sullivan, Terri N.; Sutherland, Kevin S.; Farrell, Albert D.; Taylor, Katherine A.

2015-01-01

The impact of a school-based violence prevention program, Second Step, on peer victimization and aggression, and emotion regulation was evaluated among 457 sixth graders. A cluster-randomized trial was conducted with classrooms randomly assigned to intervention (n = 14) or control (n = 14) conditions. A repeated measures analysis of covariance on…

Intraclass Correlations for Three-Level Multi-Site Cluster-Randomized Trials of Science Achievement

ERIC Educational Resources Information Center

Westine, Carl D.

2015-01-01

A cluster-randomized trial (CRT) relies on random assignment of intact clusters to treatment conditions, such as classrooms or schools (Raudenbush & Bryk, 2002). One specific type of CRT, a multi-site CRT (MSCRT), is commonly employed in educational research and evaluation studies (Spybrook & Raudenbush, 2009; Spybrook, 2014; Bloom,…

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…

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…

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 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

Evaluation of a 2-Year Physical Activity and Healthy Eating Intervention in Middle School Children

ERIC Educational Resources Information Center

Haerens, Leen; Deforche, Benedicte; Maes, Lea; Cardon, Greet; Stevens, Veerle; De Bourdeaudhuij, Ilse

2006-01-01

The aim of the present study was to evaluate the effects of a middle school physical activity and healthy eating intervention, including an environmental and computer-tailored component, and to investigate the effects of parental involvement. A random sample of 15 schools with seventh and eight graders was randomly assigned to one of three…

Evaluation of a Randomized Intervention to Delay Sexual Initiation among Fifth-Graders Followed through the Sixth Grade

ERIC Educational Resources Information Center

Koo, Helen P.; Rose, Allison; El-Khorazaty, M. Nabil; Yao, Qing; Jenkins, Renee R.; Anderson, Karen M.; Davis, Maurice; Walker, Leslie R.

2011-01-01

US adolescents initiate sex at increasingly younger ages, yet few pregnancy prevention interventions for children as young as 10-12 years old have been evaluated. Sixteen Washington, DC schools were randomly assigned to intervention versus control conditions. Beginning in 2001/02 with fifth-grade students and continuing during the sixth grade,…

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…

Preliminary Evaluation of a Tier 2 Mathematics Intervention for First-Grade Students: Using a Theory of Change to Guide Formative Evaluation Activities

ERIC Educational Resources Information Center

Clarke, Ben; Doabler, Christian T.; Strand Cary, Mari; Kosty, Derek; Baker, Scott; Fien, Hank; Smolkowski, Keith

2014-01-01

This pilot study examined the efficacy of a Tier 2 first-grade mathematics intervention program targeting whole-number understanding for students at risk in mathematics. The study used a randomized block design. Students (N = 89) were randomly assigned to treatment (Fusion) or control (standard district practice) conditions. Measures of…

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…

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

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.

What Makes a Difference: Early Head Start Evaluation Findings in a Developmental Context

ERIC Educational Resources Information Center

Love, John M.; Chazan-Cohen, Rachel; Raikes, Helen; Brooks-Gunn, Jeanne

2013-01-01

The federal Early Head Start (EHS) program began in 1995, and a randomized trial was conducted to evaluate the efficacy of 17 EHS programs. In all, 3,001 low-income families (35% African American, 24% Hispanic, and 37% White) with a pregnant women or an infant under the age of 12 months were randomly assigned to a treatment or control group (with…

A Randomized Intervention Study to Evaluate Whether Electronic Messaging Can Increase Human Papillomavirus Vaccine Completion and Knowledge among College Students

ERIC Educational Resources Information Center

Richman, Alice R.; Maddy, LaDonna; Torres, Essie; Goldberg, Ellen J.

2016-01-01

Objective: To evaluate an intervention aimed at increasing human papillomavirus (HPV) vaccine completion of the 3-dose series and knowledge. Participants: Two hundred sixty-four male and female US college students 18-26 years old who were receiving HPV vaccine dose 1. Methods: Students were randomly assigned to the intervention or control group.…

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

ERIC Educational Resources Information Center

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

2015-01-01

Purpose: 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. Method: Fifty-two Cantonese-speaking, school-age children with language impairment were assigned randomly to either the SC or the NAR treatment…

76 FR 17654 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-30

... OMB Review; Comment Request Title: Evaluation of Adolescent Pregnancy Prevention Approaches-- First... as part of the Evaluation of Adolescent Pregnancy Prevention Approaches (PPA). PPA is a random assignment evaluation designed to result in rigorous evidence on effective ways to reduce teen pregnancy. The...

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.

Commentary on "Cabozantinib in patients with advanced prostate cancer: results of a phase II randomized discontinuation trial." Smith DC, Smith MR, Sweeney C, Elfiky AA, Logothetis C, Corn PG, Vogelzang NJ, Small EJ, Harzstark AL, Gordon MS, Vaishampayan UN, Haas NB, Spira AI, Lara PN Jr, Lin CC, Srinivas S, Sella A, SchoffskiSchöffski P, Scheffold C, Weitzman AL, Hussain M, University of Michigan, Ann Arbor, MI. J Clin Oncol 2013;31(4):412-9. doi: 10.1200/JCO.2012.45.0494. Epub 2012 Nov 19.

PubMed

Trump, Donald L

2013-11-01

Cabozantinib (XL184) is an orally bioavailable tyrosine kinase inhibitor with activity against MET and vascular endothelial growth factor receptor 2. We evaluated the activity of cabozantinib in patients with castration-resistant prostate cancer (CRPC) in a phase II randomized discontinuation trial with an expansion cohort. Patients received 100mg of cabozantinib daily. Those with stable disease per RECIST at 12 weeks were randomly assigned to cabozantinib or placebo. Primary end points were objective response rate at 12 weeks and progression-free survival (PFS) after random assignment. One hundred seventy-one men with CRPC were enrolled. Random assignment was halted early based on the observed activity of cabozantinib. Seventy-two percent of patients had regression in soft tissue lesions, whereas 68% of evaluable patients had improvement on bone scan, including complete resolution in 12%. The objective response rate at 12 weeks was 5%, with stable disease in 75% of patients. Thirty-one patients with stable disease at week 12 were randomly assigned. Median PFS was 23.9 weeks (95% CI, 10.7 to 62.4 weeks) with cabozantinib and 5.9 weeks (95% CI, 5.4 to 6.6 weeks) with placebo (hazard ratio, 0.12; P<.001). Serum total alkaline phosphatase and plasma cross-linked C-terminal telopeptide of type I collagen were reduced by ≥ 50% in 57% of evaluable patients. On retrospective review, bone pain improved in 67% of evaluable patients, with a decrease in narcotic use in 56%. The most common grade 3 adverse events were fatigue (16%), hypertension (12%), and hand-foot syndrome (8%). Cabozantinib has clinical activity in men with CRPC, including reduction of soft tissue lesions, improvement in PFS, resolution of bone scans, and reductions in bone turnover markers, pain, and narcotic use. Copyright © 2013 Elsevier Inc. All rights reserved.

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…

"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.

A randomized trial of standardized nursing patient assessment using wireless devices.

PubMed

Dykes, Patricia C; Carroll, Diane L; Benoit, Angela; Coakley, Amanda; Chang, Frank; Empoliti, Joanne; Gallagher, Joan; Lasala, Cynthia; O'Malley, Rosemary; Rath, Greg; Silva, Judy; Li, Qi

2007-10-11

A complete and accurate patient assessment database is essential for effective communication, problem identification, planning and evaluation of patient status. When employed consistently for point-of-care documentation, information systems are associated with completeness and quality of documentation. The purpose of this paper is to report on the findings of a randomized, cross-over study conducted to evaluate the adequacy of a standard patient assessment module to support problem identification, care planning and tracking of nursing sensitive patient outcomes. The feasibility of wireless devices to support patient assessment data collection at the point-of-care was evaluated using wireless PDAs and tablet PCs. Seventy-nine (79) nurses from two patient care units at Massachusetts General Hospital (Boston, MA) were recruited into the study and randomized to complete patient assessment using wireless or paper devices. At the end of six weeks, nurses who where randomized to the paper assessment module were assigned to a device and those who used a device were assigned to paper for an additional six weeks. Impact was evaluated with regard to data capture, workflow implications and nurse satisfaction. Findings suggest that a standard patient assessment set promotes patient sensitive and quality data capture, which is augmented by the use of wireless devices.

A Randomized Trial of Standardized Nursing Patient Assessment Using Wireless Devices

PubMed Central

Dykes, Patricia C.; Carroll, Diane L.; Benoit, Angela; Coakley, Amanda; Chang, Frank; Empoliti, Joanne; Gallagher, Joan; Lasala, Cynthia; O’Malley, Rosemary; Rath, Greg; Silva, Judy; Li, Qi

2007-01-01

A complete and accurate patient assessment database is essential for effective communication, problem identification, planning and evaluation of patient status. When employed consistently for point-of-care documentation, information systems are associated with completeness and quality of documentation. The purpose of this paper is to report on the findings of a randomized, cross-over study conducted to evaluate the adequacy of a standard patient assessment module to support problem identification, care planning and tracking of nursing sensitive patient outcomes. The feasibility of wireless devices to support patient assessment data collection at the point-of-care was evaluated using wireless PDAs and tablet PCs. Seventy-nine (79) nurses from two patient care units at Massachusetts General Hospital (Boston, MA) were recruited into the study and randomized to complete patient assessment using wireless or paper devices. At the end of six weeks, nurses who where randomized to the paper assessment module were assigned to a device and those who used a device were assigned to paper for an additional six weeks. Impact was evaluated with regard to data capture, workflow implications and nurse satisfaction. Findings suggest that a standard patient assessment set promotes patient sensitive and quality data capture, which is augmented by the use of wireless devices. PMID:18693827

Evaluating a Brief, Video-Based Sexual Risk Reduction Intervention and Assessment Reactivity with STI Clinic Patients: Results from a Randomized Controlled Trial

PubMed Central

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

2014-01-01

We report results from a randomized controlled trial designed to evaluate the efficacy of a video-based sexual risk reduction intervention and to measure assessment reactivity. Patients (N = 1010; 56 % male; 69 % African American) receiving care at a sexually transmitted infection (STI) clinic were assigned to one of four conditions formed by crossing assessment condition (i.e., sexual health vs. general health) with intervention condition (i.e., sexual risk reduction intervention vs. general health promotion). After completing their assigned baseline assessment, participants received their assigned intervention, and subsequently returned for follow-up assessments at 3, 6, 9, and 12 months. Participants in all conditions reduced their self-reported sexual risk behavior, and the incidence of new STIs declined from baseline through the follow-ups; however, there was no effect of intervention or assessment condition. We conclude that further risk reduction will require more intensive interventions, especially in STI clinics that already provide excellent clinical care. PMID:25433653

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.

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 Semantic Differential Evaluation of Attitudinal Outcomes of Introductory Physical Science.

ERIC Educational Resources Information Center

Hecht, Alfred Roland

This study was designed to assess the attitudinal outcomes of Introductory Physical Science (IPS) curriculum materials used in schools. Random samples of 240 students receiving IPS instruction and 240 non-science students were assigned to separate Solomon four-group designs with non-equivalent control groups. Random samples of 60 traditional…

Personalized Mailed Feedback for College Drinking Prevention: A Randomized Clinical Trial

ERIC Educational Resources Information Center

Larimer, Mary E.; Lee, Christine M.; Kilmer, Jason R.; Fabiano, Patricia M.; Stark, Christopher B.; Geisner, Irene M.; Mallett, Kimberly A.; Lostutter, Ty W.; Cronce, Jessica M.; Feeney, Maggie; Neighbors, Clayton

2007-01-01

The current study was designed to evaluate the efficacy of a mailed feedback and tips intervention as a universal prevention strategy for college drinking. Participants (N = 1,488) were randomly assigned to feedback or assessment-only control conditions. Results indicated that the mailed feedback intervention had a preventive effect on drinking…

Cognitive Behavioral Principles within Group Mentoring: A Randomized Pilot Study

ERIC Educational Resources Information Center

Jent, Jason F.; Niec, Larissa N.

2009-01-01

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

Evaluating the Impact of a Multicomponent Intervention Model on Teachers' Awareness of Social Networks at the Beginning of Middle School in Rural Communities

ERIC Educational Resources Information Center

Farmer, Thomas W.; Hall, Cristin M.; Petrin, Robert; Hamm, Jill V.; Dadisman, Kimberly

2010-01-01

A randomized control trial was conducted to evaluate the impact of the Rural Early Adolescent Learning Program (Project REAL) on teachers' awareness of peer groups at the beginning of the 1st year of middle school. Two schools were randomly assigned to the intervention condition and 2 to the control condition. Thirty-nine teachers and 466 students…

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.

The effects of enhanced hexapod motion on airline pilot recurrent training and evaluation

DOT National Transportation Integrated Search

2003-08-13

A quasi-transfer experiment tested the effect of : simulator motion on recurrent evaluation and training : of airline pilots. Two groups of twenty B747-400 pilots : were randomly assigned to a flight simulator with or : without platform motion. In th...

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.

77 FR 3008 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Evaluation...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-20

... for OMB Review; Comment Request; Evaluation of the Reintegration of Ex- Offenders--Adult Program... Reintegration of Ex- Offenders--Adult Program,'' to the Office of Management and Budget (OMB) for review and... participants and staff in the random assignment evaluation of the Reintegration of Ex-Offenders-Adult Program...

Leveraging Volunteers: An Experimental Evaluation of a Tutoring Program for Struggling Readers

ERIC Educational Resources Information Center

Jacob, Robin; Armstrong, Catherine; Bowden, A. Brooks; Pan, Yilin

2016-01-01

This study evaluates the impacts and costs of the Reading Partners program, which uses community volunteers to provide one-on-one tutoring to struggling readers in under-resourced elementary schools. The evaluation uses an experimental design. Students were randomly assigned within 19 different Reading Partners sites to a program or control…

Evaluation of an Intervention to Foster Time Perspective and Career Decidedness in a Group of Italian Adolescents

ERIC Educational Resources Information Center

Ferrari, Lea; Nota, Laura; Soresi, Salvatore

2012-01-01

A structured 10-didactic unit intervention was devised to foster adolescents' time perspective and career decidedness. The study was conducted with 50 adolescents who were selected from a group of 624; 25 of the participants were randomly assigned to the control group and 25 were assigned to the experimental group. They were selected according to…

Outcomes of an HIV Prevention Peer Group Intervention for Rural Adults in Malawi

ERIC Educational Resources Information Center

Kaponda, Chrissie P. N.; Norr, Kathleen F.; Crittenden, Kathleen S.; Norr, James L.; McCreary, Linda L.; Kachingwe, Sitingawawo I.; Mbeba, Mary M.; Jere, Diana L. N.; Dancy, Barbara L.

2011-01-01

This study used a quasi-experimental design to evaluate a six-session peer group intervention for HIV prevention among rural adults in Malawi. Two rural districts were randomly assigned to intervention and control conditions. Independent random samples of community adults compared the districts at baseline and at 6 and 18 months postintervention.…

A Randomized Trial of Longitudinal Effects of Low-Intensity Responsivity Education/Prelinguistic Milieu Teaching

ERIC Educational Resources Information Center

Warren, Steven F.; Fey, Marc E.; Finestack, Lizbeth, H.; Brady, Nancy C.; Bredin-Oja, Shelley L.; Fleming, Kandace K.

2008-01-01

Purpose: To evaluate the longitudinal effects of a 6-month course of responsivity education (RE)/prelinguistic milieu teaching (PMT) for young children with developmental delay. Method: Fifty-one children, age 24-33 months, with fewer than 10 expressive words were randomly assigned to early-treatment/no-treatment groups. All treatment was added as…

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…

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.

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…

Rape Prevention with College Men: Evaluating Risk Status

ERIC Educational Resources Information Center

Stephens, Kari A.; George, William H.

2009-01-01

This study evaluates the effectiveness of a theoretically based rape prevention intervention with college men who were at high or low risk to perpetrate sexually coercive behavior. Participants (N = 146) are randomly assigned to the intervention or control group. Outcomes include rape myth acceptance, victim empathy, attraction to sexual…

77 FR 26764 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-07

... two sites, with the random assignment of AFI-eligible cases to program and control groups. The... Families (ACF) is proposing a data collection activity as part of an experimental evaluation of the Assets... outcomes? While some evaluations suggest that IDAs help low-income families save, rigorous experimental...

Evaluation of the Better Parenting Programme in Jordan

ERIC Educational Resources Information Center

Al-Hassan, Suha M.; Lansford, Jennifer E.

2011-01-01

This study evaluates the Better Parenting Programme (BPP) which has been implemented nationally in Jordan to enhance parents' knowledge, attitudes, and behaviours related to caring for young children. The participants (N = 337, 94% female) were randomly assigned to an experimental group or a control group. The experimental group participated in…

The Effects of Band Labels on Evaluators' Judgments of Musical Performance

ERIC Educational Resources Information Center

Silvey, Brian A.

2009-01-01

This study investigates the effects of band labels on evaluators' judgments of musical performance. High school concert band members (n = 72), wind ensemble members ( n = 77), and band directors (n = 8) were randomly assigned to a band label or no label group. Only the band label group was given evaluation forms that specified the group playing…

A Cluster Randomized Trial of the Social Skills Improvement System-Classwide Intervention Program (SSIS-CIP) in First Grade

ERIC Educational Resources Information Center

DiPerna, James Clyde; Lei, Puiwa; Cheng, Weiyi; Hart, Susan Crandall; Bellinger, Jillian

2018-01-01

The purpose of this study was to evaluate the efficacy of a universal social skills program, the Social Skills Improvement System Classwide Intervention Program (SSIS-CIP; Elliott & Gresham, 2007), for students in first grade. Classrooms from 6 elementary schools were randomly assigned to treatment or business-as-usual control conditions.…

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…

A Randomized Controlled Trial of a Parent-Centered Intervention in Preventing Substance Use and HIV Risk Behaviors in Hispanic Adolescents

ERIC Educational Resources Information Center

Prado, Guillermo; Pantin, Hilda; Briones, Ervin; Schwartz, Seth J.; Feaster, Daniel; Huang, Shi; Sullivan, Summer; Tapia, Maria I.; Sabillon, Eduardo; Lopez, Barbara; Szapocznik, Jose

2007-01-01

The present study evaluated the efficacy of Familias Unidas + Parent-Preadolescent Training for HIV Prevention (PATH), a Hispanic-specific, parent-centered intervention, in preventing adolescent substance use and unsafe sexual behavior. Two hundred sixty-six 8th-grade Hispanic adolescents and their primary caregivers were randomly assigned to 1 of…

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

ERIC Educational Resources Information Center

Yu, Bing; Hong, Guanglei

2012-01-01

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

The Effect of Teacher-Family Communication on Student Engagement: Evidence from a Randomized Field Experiment

ERIC Educational Resources Information Center

Kraft, Matthew A.; Dougherty, Shaun M.

2013-01-01

In this study, we evaluate the efficacy of teacher communication with parents and students as a means of increasing student engagement. We estimate the causal effect of teacher communication by conducting a randomized field experiment in which sixth- and ninth-grade students were assigned to receive a daily phone call home and a text/written…

A Randomized Controlled Trial of a Parent Training and Emotion Socialization Program for Families of Hyperactive Preschool-Aged Children

ERIC Educational Resources Information Center

Herbert, Sharonne D.; Harvey, Elizabeth A.; Roberts, Jasmin L.; Wichowski, Kayla; Lugo-Candelas, Claudia I.

2013-01-01

The present study evaluated the effectiveness of a parent training and emotion socialization program designed specifically for hyperactive preschoolers. Participants were 31 preschool-aged children whose parents were randomly assigned to a parent training (PT) or waitlist (WL) control group. PT parents took part in a 14-week parenting program that…

ModerateDrinking.com and Moderation Management: Outcomes of a Randomized Clinical Trial with Non-Dependent Problem Drinkers

ERIC Educational Resources Information Center

Hester, Reid K.; Delaney, Harold D.; Campbell, William

2011-01-01

Objective: To evaluate the effectiveness of a web-based protocol, ModerateDrinking.com (MD; "www.moderatedrinking.com") combined with use of the online resources of Moderation Management (MM; "www.moderation.org") as opposed to the use of the online resources of MM alone. Method: We randomly assigned 80 problem drinkers to…

Method for Evaluation of Outage Probability on Random Access Channel in Mobile Communication Systems

NASA Astrophysics Data System (ADS)

Kollár, Martin

2012-05-01

In order to access the cell in all mobile communication technologies a so called random-access procedure is used. For example in GSM this is represented by sending the CHANNEL REQUEST message from Mobile Station (MS) to Base Transceiver Station (BTS) which is consequently forwarded as an CHANNEL REQUIRED message to the Base Station Controller (BSC). If the BTS decodes some noise on the Random Access Channel (RACH) as random access by mistake (so- called ‘phantom RACH') then it is a question of pure coincidence which èstablishment cause’ the BTS thinks to have recognized. A typical invalid channel access request or phantom RACH is characterized by an IMMEDIATE ASSIGNMENT procedure (assignment of an SDCCH or TCH) which is not followed by sending an ESTABLISH INDICATION from MS to BTS. In this paper a mathematical model for evaluation of the Power RACH Busy Threshold (RACHBT) in order to guaranty in advance determined outage probability on RACH is described and discussed as well. It focuses on Global System for Mobile Communications (GSM) however the obtained results can be generalized on remaining mobile technologies (ie WCDMA and LTE).

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

Unexpected benefits of deciding by mind wandering

PubMed Central

Giblin, Colleen E.; Morewedge, Carey K.; Norton, Michael I.

2013-01-01

The mind wanders, even when people are attempting to make complex decisions. We suggest that mind wandering—allowing one's thoughts to wander until the “correct” choice comes to mind—can positively impact people's feelings about their decisions. We compare post-choice satisfaction from choices made by mind wandering to reason-based choices and randomly assigned outcomes. Participants chose a poster by mind wandering or deliberating, or were randomly assigned a poster. Whereas forecasters predicted that participants who chose by mind wandering would evaluate their outcome as inferior to participants who deliberated (Experiment 1), participants who used mind wandering as a decision strategy evaluated their choice just as positively as did participants who used deliberation (Experiment 2). In some cases, it appears that people can spare themselves the effort of deliberation and instead “decide by wind wandering,” yet experience no decrease in satisfaction. PMID:24046760

Evaluating the Effectiveness of Tools for Online Database Instruction

ERIC Educational Resources Information Center

Mery, Yvonne; DeFrain, Erica; Kline, Elizabeth; Sult, Leslie

2014-01-01

The intent of this study was to evaluate the Guide on the Side (Gots), an online learning tool developed by the University of Arizona Libraries, and a screencast tutorial for teaching information literacy and database searching skills. Ninety undergraduate students were randomly assigned into three groups: group 1 completed a GotS tutorial; group…

76 FR 75549 - Agency Information Collection Activities; Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-02

... at http://www.admongo.gov . The proposed evaluation will test a large group of students in these..., one hour of online game playing, one hour of homework assignments, and 20 minutes for the test). With... evaluation will involve a randomized controlled trial of the Admongo program in one or more school districts...

Parenting after Divorce: Evaluation of Preventive Programs for Divorcing Families.

ERIC Educational Resources Information Center

Warren, Nancy J.; And Others

Preventive educational programs are potentially useful in reducing the effects of divorce on children and families. Parenting After Divorce is an ongoing study designed to evaluate preventive programs. Divorcing families with children aged 7-12 are identified from court records and contacted to participate. Families are randomly assigned to one of…

Impact Evaluation of the U.S. Department of Education's Student Mentoring Program. Final Report. NCEE 2009-4047

ERIC Educational Resources Information Center

Bernstein, Lawrence; Rappaport, Catherine Dun; Olsho, Lauren; Hunt, Dana; Levin, Marjorie

2009-01-01

This report summarizes the findings from a national evaluation of mentoring programs funded under the U.S. Department of Education's Student Mentoring Program. The impact evaluation used an experimental design in which students were randomly assigned to a treatment or control group. Thirty-two purposively selected School Mentoring Programs and…

The Impact of Short-Term Science Teacher Professional Development on the Evaluation of Student Understanding and Errors Related to Natural Selection

ERIC Educational Resources Information Center

Buschang, Rebecca Ellen

2012-01-01

This study evaluated the effects of a short-term professional development session. Forty volunteer high school biology teachers were randomly assigned to one of two professional development conditions: (a) developing deep content knowledge (i.e., control condition) or (b) evaluating student errors and understanding in writing samples (i.e.,…

Early Effects of Responsivity Education/Prelinguistic Milieu Teaching for Children with Developmental Delays and Their Parents

ERIC Educational Resources Information Center

Fey, Marc E.; Warren, Steven F.; Brady, Nancy; Finestack, Lizbeth H.; Bredin-Oja, Shelley L.; Fairchild, Martha; Sokol, Shari; Yoder, Paul J.

2006-01-01

Purpose: To evaluate the efficacy of a 6-month course of responsivity education/prelinguistic milieu teaching (RE/PMT) for children with developmental delay and RE/PMT's effects on parenting stress in a randomized clinical trial. Method: Fifty-one children, age 24-33 months, with no more than 10 expressive words or signs, were randomly assigned to…

Estimates of Intraclass Correlation for Variables Related to Behavioral HIV/STD Prevention in a Predominantly African American and Hispanic Sample of Young Women

ERIC Educational Resources Information Center

Pals, Sherri L.; Beaty, Brenda L.; Posner, Samuel F.; Bull, Sheana S.

2009-01-01

Studies designed to evaluate HIV and STD prevention interventions often involve random assignment of groups such as neighborhoods or communities to study conditions (e.g., to intervention or control). Investigators who design group-randomized trials (GRTs) must take the expected intraclass correlation coefficient (ICC) into account in sample size…

Evaluation of a Treatment Approach Combining Nicotine Gum with Self-Guided Behavioral Treatments for Smoking Relapse Prevention.

ERIC Educational Resources Information Center

Killen, Joel D.; And Others

1990-01-01

Randomly assigned 1,218 smokers to cells in 4 (nicotine gum delivered ad lib, fixed regimen nicotine gum, placebo gum, no gum) x 3 (self-selected relapse prevention modules, randomly administered modules, no modules) design. Subjects receiving nicotine gum were more likely to be abstinent at 2- and 6-month followups. Fixed regimen accounted for…

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…

Review of Three Recent Randomized Trials of School-Based Mentoring: Making Sense of Mixed Findings. Social Policy Report. Volume 24, Number 3

ERIC Educational Resources Information Center

Wheeler, Marc E.; Keller, Thomas E.; DuBois, David L.

2010-01-01

Between 2007 and 2009, reports were released on the results of three separate large-scale random assignment studies of the effectiveness of school-based mentoring programs for youth. The studies evaluated programs implemented by Big Brothers Big Sisters of America (BBBSA) affiliates (Herrera et al., 2007), Communities In Schools of San Antonio,…

Does Acceptance and Relationship Focused Behavior Therapy Contribute to Bupropion Outcomes? A Randomized Controlled Trial of Functional Analytic Psychotherapy and Acceptance and Commitment Therapy for Smoking Cessation

ERIC Educational Resources Information Center

Gifford, Elizabeth V.; Kohlenberg, Barbara S.; Hayes, Steven C.; Pierson, Heather M.; Piasecki, Melissa P.; Antonuccio, David O.; Palm, Kathleen M.

2011-01-01

This study evaluated a treatment combining bupropion with a novel acceptance and relationship focused behavioral intervention based on the acceptance and relationship context (ARC) model. Three hundred and three smokers from a community sample were randomly assigned to bupropion, a widely used smoking cessation medication, or bupropion plus…

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.

A Controlled Evaluation of Family Behavior Therapy in Concurrent Child Neglect and Drug Abuse

PubMed Central

Donohue, Brad; Azrin, Nathan H.; Bradshaw, Kelsey; Van Hasselt, Vincent B.; Cross, Chad L.; Urgelles, Jessica; Romero, Valerie; Hill, Heather H.; Allen, Daniel N.

2015-01-01

Objective Approximately 50% of Child Protective Service (CPS) referrals abuse drugs; yet, existing treatment studies in this population have been limited to case examinations. Therefore, a family-based behavioral therapy was evaluated in mothers referred from CPS for child neglect and drug abuse utilizing a controlled experimental design. Method 72 mothers evidencing drug abuse or dependence and child neglect were randomly assigned to Family Behavior Therapy (FBT) or Treatment as Usual (TAU). Participants were assessed at baseline, 6- month-, and 10-month post-randomization. Results As hypothesized, intent-to-treat repeated measures analyses revealed mothers referred for child neglect not due to their children being exposed to illicit drugs demonstrated better outcomes in child maltreatment potential from baseline to 6- and 10-month post-randomization assessments when assigned to FBT, as compared with TAU mothers and FBT mothers who were referred due to child drug exposure. Similar results occurred for hard drug use from baseline to 6- and 10-month post-randomization. However, TAU mothers referred due to child drug exposure were also found to decrease their hard drug use more than TAU mothers of non-drug exposed children and FBT mothers of drug exposed children at 6- and 10-month post-randomization. Although effect sizes for mothers assigned to FBT were slightly larger for marijuana use than TAU (medium vs. large), these differences were not statistically significant. Specific to secondary outcomes, mothers in FBT, relative to TAU, increased time employed from baseline to 6- and 10-month post-randomization. Mothers in FBT, compared to TAU, also decreased HIV risk from baseline to 6-month post-randomization. There were no differences in outcome between FBT and TAU for number of days children were in CPS custody and alcohol intoxication, although FBT mothers demonstrated marginal decreases (p = .058) in incarceration from baseline to 6-month post-randomization relative to TAU mothers. Conclusion Family-based behavioral treatment programs offer promise in mothers who have been reported to CPS for concurrent substance abuse and child neglect of their children. However, continued intervention development in this population is very much needed. PMID:24841866

The Evaluation of Enhanced Academic Instruction in After-School Programs: Findings After the First Year of Implementation. NCEE 2008-4021

ERIC Educational Resources Information Center

Black, Alison Rebeck; Doolittle, Fred; Zhu, Pei; Unterman, Rebecca; Grossman, Jean Baldwin

2008-01-01

This report presents findings, after one year of program implementation, from the Evaluation of Enhanced Academic Instruction in After-School Programs--a two-year intervention and random assignment evaluation of adapted models of regular-school-day math and reading instruction in after-school settings for students in grades 2 through 5. This…

The Impact of Short-Term Science Teacher Professional Development on the Evaluation of Student Understanding and Errors Related to Natural Selection. CRESST Report 822

ERIC Educational Resources Information Center

Buschang, Rebecca E.

2012-01-01

This study evaluated the effects of a short-term professional development session. Forty volunteer high school biology teachers were randomly assigned to one of two professional development conditions: (a) developing deep content knowledge (i.e., control condition) or (b) evaluating student errors and understanding in writing samples (i.e.,…

Evaluation of safe performance secondary school driver education curriculum demonstration project

DOT National Transportation Integrated Search

1983-06-01

The primary objective of this Project was to determine the crash reduction potential of a quality, competency-based driver training program known as the Safe Performance Curriculum (SPC). The experimental design called for the random assignment of 18...

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...

Evaluation of a Core Team Centred Professional Development Programme for Building a Whole-School Cooperative Problem Solving Approach to Conflict

ERIC Educational Resources Information Center

White, Andrew Jonathan; Wertheim, Eleanor H.; Freeman, Elizabeth; Trinder, Margot

2013-01-01

This study evaluated a professional learning approach using a core team (CT) model to assist primary (elementary) schools to develop whole-school collaborative conflict resolution processes. Thirteen schools were matched and randomly assigned to the enhancing relationships in school communities programme ("n"?=?10) or a non-programme…

Do Sex, Sex-Role Orientation, and Exposure to Gender-Congruent Therapy Models Influence Receptivity to Psychotherapy?

ERIC Educational Resources Information Center

Park, Heather L.; Hatchett, Gregory T.

2006-01-01

This study had two objectives. The first objective was to evaluate how well sex and sex-role orientation predicted receptivity to psychotherapy. The second objective was to evaluate whether exposure to gender-congruent therapy videos influenced participants' receptivity to psychotherapy. Participants were randomly assigned to three conditions: (1)…

Evaluations of Technology-Assisted Small-Group Tutoring for Struggling Readers

ERIC Educational Resources Information Center

Madden, Nancy A.; Slavin, Robert E.

2017-01-01

This article reports on 2 experiments in inner-city Baltimore evaluating a computer-assisted tutoring approach, Tutoring With Alphie (TWA), in which 1 paraprofessional can work with up to 6 children at a time. In Study 1, we randomly assigned 14 schools to receive TWA or to continue with whatever approaches they were currently using. Each…

Evaluation of CHANGE, an Involuntary Cognitive Program for High-Risk Inmates

ERIC Educational Resources Information Center

Hogan, Nancy L.; Lambert, Eric G.; Barton-Bellessa, Shannon M.

2012-01-01

Prison violence is a major concern in most correctional institutions. One intervention frequently used to reduce violent behavior is cognitive therapy. An involuntary cognitive program at a Midwestern state prison was evaluated for its impact on official misconduct. A total of 213 inmates were randomly assigned to the treatment (CHANGE) group (n =…

A Wilderness Adventure Program as an Alternative for Juvenile Probationers: An Evaluation.

ERIC Educational Resources Information Center

Winterdyk, John Albert

A true experimental design with 60 male probationers, ages 13-16, was used to evaluate the viability of an Ontario-based 21-day wilderness adventure program as an alternative for adjudicated juveniles placed on probation. Participants were randomly assigned to a control group and an experimental group. The experimental group was subdivided into 3…

Evaluation of immunological and physiological parameters associated with an infectious bovine rhinotracheitis viral challenge in beef steers

USDA-ARS?s Scientific Manuscript database

To evaluate the effects infectious bovine rhinotracheitis virus (IBRV) has on immunological and physiological parameters of cattle; 12 Angus crossbred steers (228.82 ± 22.15 kg) were randomly assigned to either a Control group or an IBRV challenged group. Prior to the challenge, steers were fitted w...

Celebration Intoxication: An Evaluation of 21St Birthday Alcohol Consumption

ERIC Educational Resources Information Center

Neighbors, Clayton; Spieker, Casey J.; Oster-Aaland, Laura; Lewis, Melissa A.; Bergstrom, Rochelle L.

2005-01-01

The authors designed this study to evaluate the prevalence and magnitude of heavy drinking among college students in celebrating their 21st birthdays and the impact of a birthday card suggesting moderation. The authors randomly assigned subjects to receive or not receive the card approximately 1 week prior to their birthday. Approximately 1 week…

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…

WRITING SKILLS--ARE LARGE CLASSES CONDUCTIVE TO EFFECTIVE LEARNING.

ERIC Educational Resources Information Center

HOPPER, HAROLD H.; KELLER, HELEN

BY A STRATIFIED RANDOM SAMPLING, 274 STUDENTS WERE ASSIGNED TO THREE SECTIONS OF 56 STUDENTS EACH AND FOUR SECTIONS OF 28 STUDENTS. EVALUATION OF THE INSTRUCTION IN THE LARGE AND SMALL GROUPS INVOLVED ANALYSIS OF TWO ESSAYS AND INSTRUCTOR-STUDENT EVALUATIONS. WHILE THERE WAS SOME VARIATION IN STUDENT PREFERENCES, THE RESULTS OF THE PRETEST AND THE…

The Coping Cat Program for Children with Anxiety and Autism Spectrum Disorder: A Pilot Randomized Controlled Trial

ERIC Educational Resources Information Center

McNally Keehn, Rebecca H.; Lincoln, Alan J.; Brown, Milton Z.; Chavira, Denise A.

2013-01-01

The purpose of this pilot study was to evaluate whether a modified version of the Coping Cat program could be effective in reducing anxiety in children with autism spectrum disorder (ASD). Twenty-two children (ages 8-14; IQ greater than or equal to 70) with ASD and clinically significant anxiety were randomly assigned to 16 sessions of the Coping…

Supplementation with 1000 IU vitamin D/d leads to parathyroid hormone suppression, but not increased fractional calcium absorption, in 4-8-y-old children: A double-blind randomized controlled trial

USDA-ARS?s Scientific Manuscript database

The effects of vitamin D supplementation in healthy prepubertal children on physiologic outcomes have not been investigated. The objective was to evaluate the effects of supplementation with 1000 IU vitamin D(3)/d on calcium absorption. In a double-blind, placebo-controlled trial, we randomly assign...

On marker-based parentage verification via non-linear optimization.

PubMed

Boerner, Vinzent

2017-06-15

Parentage verification by molecular markers is mainly based on short tandem repeat markers. Single nucleotide polymorphisms (SNPs) as bi-allelic markers have become the markers of choice for genotyping projects. Thus, the subsequent step is to use SNP genotypes for parentage verification as well. Recent developments of algorithms such as evaluating opposing homozygous SNP genotypes have drawbacks, for example the inability of rejecting all animals of a sample of potential parents. This paper describes an algorithm for parentage verification by constrained regression which overcomes the latter limitation and proves to be very fast and accurate even when the number of SNPs is as low as 50. The algorithm was tested on a sample of 14,816 animals with 50, 100 and 500 SNP genotypes randomly selected from 40k genotypes. The samples of putative parents of these animals contained either five random animals, or four random animals and the true sire. Parentage assignment was performed by ranking of regression coefficients, or by setting a minimum threshold for regression coefficients. The assignment quality was evaluated by the power of assignment (P[Formula: see text]) and the power of exclusion (P[Formula: see text]). If the sample of putative parents contained the true sire and parentage was assigned by coefficient ranking, P[Formula: see text] and P[Formula: see text] were both higher than 0.99 for the 500 and 100 SNP genotypes, and higher than 0.98 for the 50 SNP genotypes. When parentage was assigned by a coefficient threshold, P[Formula: see text] was higher than 0.99 regardless of the number of SNPs, but P[Formula: see text] decreased from 0.99 (500 SNPs) to 0.97 (100 SNPs) and 0.92 (50 SNPs). If the sample of putative parents did not contain the true sire and parentage was rejected using a coefficient threshold, the algorithm achieved a P[Formula: see text] of 1 (500 SNPs), 0.99 (100 SNPs) and 0.97 (50 SNPs). The algorithm described here is easy to implement, fast and accurate, and is able to assign parentage using genomic marker data with a size as low as 50 SNPs.

Evaluation of a visual risk communication tool: effects on knowledge and perception of blood transfusion risk.

PubMed

Lee, D H; Mehta, M D

2003-06-01

Effective risk communication in transfusion medicine is important for health-care consumers, but understanding the numerical magnitude of risks can be difficult. The objective of this study was to determine the effect of a visual risk communication tool on the knowledge and perception of transfusion risk. Laypeople were randomly assigned to receive transfusion risk information with either a written or a visual presentation format for communicating and comparing the probabilities of transfusion risks relative to other hazards. Knowledge of transfusion risk was ascertained with a multiple-choice quiz and risk perception was ascertained by psychometric scaling and principal components analysis. Two-hundred subjects were recruited and randomly assigned. Risk communication with both written and visual presentation formats increased knowledge of transfusion risk and decreased the perceived dread and severity of transfusion risk. Neither format changed the perceived knowledge and control of transfusion risk, nor the perceived benefit of transfusion. No differences in knowledge or risk perception outcomes were detected between the groups randomly assigned to written or visual presentation formats. Risk communication that incorporates risk comparisons in either written or visual presentation formats can improve knowledge and reduce the perception of transfusion risk in laypeople.

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

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.

Pilot Evaluation of a Sexual Abuse Prevention Program for Taiwanese Children

ERIC Educational Resources Information Center

Chen, Yi-Chuen; Fortson, Beverly L.; Tseng, Kai-Wen

2012-01-01

The purpose of the current study was to develop and evaluate the efficacy of a school-based child sexual abuse prevention program for Taiwanese children. Forty-six Taiwanese children age 6 to 13 were divided into one of two groups based on their school grade and then randomly assigned to a skills-based child sexual abuse prevention program who…

Just a Harmless Website?: An Experimental Examination of RateMyProfessors.com's Effect on Student Evaluations

ERIC Educational Resources Information Center

Lewandowski, Gary W., Jr.; Higgins, Emma; Nardone, Natalie N.

2012-01-01

This set of experiments assessed the influence of RateMyProfessors.com profiles, and the perceived credibility of those profiles, on students' evaluations of professors and retention of material. In Study 1, 302 undergraduates were randomly assigned to read positive or negative RateMyProfessors.com profiles with comments that focused on…

The Evaluation of Charter School Impacts: Final Report. NCEE 2010-4029

ERIC Educational Resources Information Center

Gleason, Philip; Clark, Melissa; Tuttle, Christina Clark; Dwoyer, Emily

2010-01-01

Adding to the growing debate and evidence base on the effects of charter schools, this evaluation was conducted in 36 charter middle schools in 15 states. It compares the outcomes of 2,330 students who applied to these schools and were randomly assigned by lotteries to be admitted (lottery winners) or not admitted (lottery losers) to the schools.…

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…

Multisystemic Therapy Effects on Attempted Suicide by Youths Presenting Psychiatric Emergencies

ERIC Educational Resources Information Center

Huey, Stanley J.; Henggeler, Scott W.; Rowland, Melisa D.; Halliday-Boykins, Colleen A.; Cunningham, Phillippe B.; Pickrel, Susan G.; Edwards, James

2004-01-01

Objective: To evaluate the efficacy of multisystemic therapy (MST) in reducing attempted suicide among predominantly African American youths referred for emergency psychiatric hospitalization. Method: Youths presenting psychiatric emergencies were randomly assigned to MST or hospitalization. Indices of attempted suicide, suicidal ideation,…

A randomized controlled trial of nitrous oxide for intrauterine device insertion in nulliparous women.

PubMed

Singh, Rameet H; Thaxton, Lauren; Carr, Shannon; Leeman, Lawrence; Schneider, Emily; Espey, Eve

2016-11-01

To evaluate the effectiveness of inhaled nitrous oxide for pain management among nulliparous women undergoing intrauterine device (IUD) insertion. A double-blind, randomized controlled trial was conducted among nulliparous women aged 13-45years who underwent IUD insertion at a US center between October 1, 2013, and August 31, 2014. Using a computer-generated randomization sequence, participants were randomly assigned to inhale either oxygen (O 2 ) or a mixture of 50% nitrous oxide and 50% oxygen (N 2 O/O 2 ) through a nasal mask for 2minutes before insertion. Only the person administering the inhalation agent was aware of group assignment. The primary outcome was maximum pain assessed 2minutes after insertion via a 100-mm visual analog scale. Analyses were by intention to treat. Forty women were assigned to each group. Mean maximum pain score at the time of insertion was 54.3±24.8mm for the N 2 O/O 2 group and 55.3±20.9mm for the O 2 group (P=0.86). Adverse effects were reported for 6 (15%) women in the N 2 O/O 2 group and 7 (18%) in the O 2 group (P=0.32). N 2 O/O 2 did not reduce the pain of IUD insertion among nulliparous women. ClinicalTrials.gov: NCT02391714. Published by Elsevier Ireland Ltd.

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.

A randomized clinical trial on the effects of remote intercessory prayer in the adverse outcomes of pregnancies.

PubMed

da Rosa, Maria Inês; Silva, Fabio Rosa; Silva, Bruno Rosa; Costa, Luciana Carvalho; Bergamo, Angela Mendes; Silva, Napoleão Chiaramonte; Medeiros, Lidia Rosi de Freitas; Battisti, Iara Denise Endruweit; Azevedo, Rafael

2013-08-01

The scope of this article was to investigate whether intercessory prayer (IP) influences the adverse outcomes of pregnancies. A double-blind, randomized clinical trial was conducted with 564 pregnant women attending a prenatal public health care service. The women were randomly assigned to an IP group or to a control group (n = 289 per group). They were simultaneously and randomly assigned to practice prayer off-site or not. The following parameters were evaluated: Apgar scores, type of delivery and birth weight. The mean age of the women was 25.1 years of age (± 7.4), and the average gestational age was 23.4 weeks (± 8.1). The average number of years of schooling for the women was 8.1 years (± 3.1). The women in the IP and control groups presented a similar number of adverse medical events with non-significant p. No significant differences were detected in the frequency of adverse outcomes in pregnant women who practiced IP and those in the control group.

Interpersonal Skills Training: Evaluation of a Program with Adult Male Offenders.

ERIC Educational Resources Information Center

Bornstein, Philip H.; And Others

1979-01-01

To assess the efficacy of an interpersonal skill training program, adult offenders were randomly assigned to either interpersonal effectiveness training or waiting-list control. Results indicated interpersonal effectiveness training group superiority on Interpersonal Behavior Role-Play Test training and generalization assessment items. Findings…

Novel Interventions for Bovine Respiratory Disease.

USDA-ARS?s Scientific Manuscript database

Two treatments were evaluated in commercial feedlot heifers to determine the effects of a yeast supplement on immune and metabolic responses to a combined viral-bacterial respiratory disease challenge. Beef heifers (n = 32; 324 ± 19.2 kg BW) were selected and randomly assigned to one of two treatmen...

40 CFR 799.9620 - TSCA neurotoxicity screening battery.

Code of Federal Regulations, 2012 CFR

2012-07-01

... dose and control group for behavioral testing. At least five males and five females should be used in each dose and control group for terminal neuropathology. If interim neuropathological evaluations are... of the study. Animals shall be randomly assigned to treatment and control groups. (3) Control groups...

40 CFR 799.9620 - TSCA neurotoxicity screening battery.

Code of Federal Regulations, 2014 CFR

2014-07-01

... dose and control group for behavioral testing. At least five males and five females should be used in each dose and control group for terminal neuropathology. If interim neuropathological evaluations are... of the study. Animals shall be randomly assigned to treatment and control groups. (3) Control groups...

40 CFR 799.9620 - TSCA neurotoxicity screening battery.

Code of Federal Regulations, 2013 CFR

2013-07-01

... dose and control group for behavioral testing. At least five males and five females should be used in each dose and control group for terminal neuropathology. If interim neuropathological evaluations are... of the study. Animals shall be randomly assigned to treatment and control groups. (3) Control groups...

Rigorously Assessing Whether the Data Backs the Back School

PubMed Central

Vinh, David T.; Johnson, Craig W.; Phelps, Cynthia L.

2003-01-01

A rigorous between-subjects methodology employing independent random samples and having broad clinical applicability was designed and implemented to evaluate the effectiveness of back safety and patient transfer training interventions for both hospital nurses and nursing assistants. Effects upon self-efficacy, cognitive, and affective measures are assessed for each of three back safety procedures. The design solves the problem of obtaining randomly assigned independent controls where all experimental subjects must participate in the training interventions. PMID:14728544

Evaluating interactive technology for an evolving case study on learning and satisfaction of graduate nursing students.

PubMed

Vogt, Marjorie A; Schaffner, Barbara H

2016-07-01

Nursing education is challenged to prepare students for complex healthcare needs through the integration of teamwork and informatics. Technology has become an important teaching tool in the blended classroom to enhance group based learning experiences. Faculty evaluation of classroom technologies is imperative prior to adoption. Few studies have directly compared various technologies and their impact on student satisfaction and learning. The purpose of this study was to evaluate technology enhanced teaching methods on the learning and satisfaction of graduate students in an advanced pharmacology class using an unfolding case study. After IRB approval, students were randomly assigned to one of three groups: blogging group, wiki group or webinar group. Students completed the evolving case study using the assigned interactive technology. Student names were removed from the case studies. Faculty evaluated the case study using a rubric, while blinded to the assigned technology method used. No significant difference was found on case study grades, the range of grades on the assignment demonstrated little differences between the methods used. Students indicated an overall positive impact related to networking and collaboration on a satisfaction survey. Impact of technology methods needs to be explored in other areas of graduate nursing education. Copyright © 2016 Elsevier Ltd. All rights reserved.

Anticipating evaluative social interactions involving persons with disabilities.

PubMed

Santuzzi, Alecia M

2011-08-01

Similar to other types of social interactions, the expected outcomes of interactions between persons with and without disabilities likely are influenced by global self-esteem such that individuals with high self-esteem should fare better than those with low self-esteem. The present set of laboratory studies examined whether simple and complex evaluative situations affect the role of self-esteem when anticipating interactions with individuals who have a physical disability. In Study 1, participants completed a measure of global self-esteem and then were randomly assigned to expect either a brief (5 minutes) or extended (45 minutes) interaction with a confederate in a wheelchair. Participants then completed measures of state affect and meta-evaluations (expected evaluations from the partner). Study 2 replicated the design of Study 1 and additionally randomly assigned participants to be outcome-dependent on the partner or not. Study 1 found that individuals reported affective experiences and expected meta-evaluations that were consistent with global self-esteem when expecting a brief interaction but not an extended interaction with the partner. Study 2 replicated and extended the results from Study 1, demonstrating that self-esteem resumed a priority when participants expected an extended interaction that also placed the participant in an outcome-dependent role. Taken together, the results seem to support a dilution of the role of self-esteem in simple evaluative situations but not in situations that are nonevaluative or situations with combined evaluative factors.

More Graduates: Two-Year Results from an Evaluation of Accelerated Study in Associate Programs (ASAP) for Developmental Education Students. Policy Brief

ERIC Educational Resources Information Center

Scrivener, Susan; Weiss, Michael J.

2013-01-01

This policy brief presents results from a random assignment evaluation of the City University of New York's Accelerated Study in Associate Programs (ASAP). An ambitious and promising endeavor, ASAP provides a comprehensive array of services and supports to help community college students graduate and to help them graduate sooner. The evaluation…

Abriendo Puertas/Opening Doors Parenting Program: Summary Report of Program Implementation and Impacts. Publication #2014-24

ERIC Educational Resources Information Center

Moore, Kristin A.; Caal, Selma; Lawner, Elizabeth K.; Rojas, Angela; Walker, Karen

2014-01-01

Child Trends conducted a random assignment evaluation of the Abriendo Puertas/Opening Doors program, one of the largest programs in the United States working with low-income Latino parents of children ages zero to five. Since it began in 2007, the program has served over 30,000 parents/families in 34 states. The evaluation study examined the…

Protecting You/Protecting Me: Evaluation of a Student-Led Alcohol Prevention and Traffic Safety Program for Elementary Students

ERIC Educational Resources Information Center

Bell, Mary Lou; Baker, Tara Kelley; Falb, Timothy; Roberts-Gray, Cindy

2005-01-01

Pre- and post-surveys of self-protective knowledge and skills in third, fourth, and fifth grade classrooms (n = 24) randomly assigned to a model program for alcohol prevention and traffic safety or to comparison group (n = 24 classrooms) were analyzed to evaluate replicability of immediate positive effects of first-year exposure and to test…

Engaging Parents of Children with and without Asthma in Smoking-Specific Parenting: Results from a 3-Year Randomized Controlled Trial Evaluation

ERIC Educational Resources Information Center

Ringlever, Linda; Hiemstra, Marieke; Engels, Rutger C. M. E.; van Schayck, Onno C. P.; Otten, Roy

2016-01-01

The present study evaluated long-term effects of a home-based smoking prevention program targeting smoking-specific parenting in families with children with and without asthma. A total of 1398 non-smoking children ("mean age" 10.1) participated, of which 197 (14.1%) were diagnosed with asthma. Families were blinded to group assignment.…

One Year Follow-Up to Modular Cognitive Behavioral Therapy for the Treatment of Pediatric Anxiety Disorders in an Elementary School Setting

ERIC Educational Resources Information Center

Galla, Brian M.; Wood, Jeffrey J.; Chiu, Angela W.; Langer, David A.; Jacobs, Jeffrey; Ifekwunigwe, Muriel; Larkins, Clare

2012-01-01

The current study sought to evaluate the relative long-term efficacy of a modularized cognitive behavioral therapy (CBT) program for children with anxiety disorders. Twenty four children (5-12 years old) randomly assigned to modular CBT or a 3-month waitlist participated in a 1-year follow-up assessment. Independent evaluators blind to treatment…

Evaluation of Three Osteoporosis Prevention Programs for Young Women: Application of the Health Belief Model

ERIC Educational Resources Information Center

Lein, Donald H.; Turner, Lori; Wilroy, Jereme

2016-01-01

Purpose: The purpose of this study was to evaluate the effectiveness of theory-based osteoporosis prevention programs on calcium and vitamin D intakes and osteoporosis health beliefs in young women. Methods: Women (N = 152) aged 19 to 25 years were randomly assigned to one of 3 groups: a brochure group (n = 51), a computer-tailored program group…

Do Early Literacy Skills in Children's First Language Promote Development of Skills in Their Second Language? An Experimental Evaluation of Transfer

ERIC Educational Resources Information Center

Goodrich, J. Marc; Lonigan, Christopher J.; Farver, JoAnn M.

2013-01-01

The purpose of this study was to evaluate the cross-language transfer of the emergent literacy skills of preschoolers who were Spanish-speaking language-minority children in the context of an experimental intervention study. Ninety-four children were randomly assigned either to a control condition (HighScope Preschool Curriculum) or to receive…

Group Matching: Is This a Research Technique to Be Avoided?

ERIC Educational Resources Information Center

Ross, Donald C.; Klein, Donald F.

1988-01-01

The variance of the sample difference and the power of the "F" test for mean differences were studied under group matching on covariates and also under random assignment. Results shed light on systematic assignment procedures advocated to provide more precise estimates of treatment effects than simple random assignment. (TJH)

Effects of the SAFE Children preventive intervention on developmental trajectories of attention-deficit/hyperactivity disorder symptoms.

PubMed

Fowler, Patrick J; Henry, David B; Schoeny, Michael; Gorman-Smith, Deborah; Tolan, Patrick H

2014-11-01

This study examined whether a family-based preventive intervention for inner-city children entering the first grade could alter the developmental course of attention-deficit/hyperactivity disorder (ADHD) symptoms. Participants were 424 families randomly selected and randomly assigned to a control condition (n = 192) or Schools and Families Educating Children (SAFE) Children (n = 232). SAFE Children combined family-focused prevention with academic tutoring to address multiple developmental-ecological needs. A booster intervention provided in the 4th grade to randomly assigned children in the initial intervention (n =101) evaluated the potential of increasing preventive effects. Follow-up occurred over 5 years with parents and teachers reporting on attention problems. Growth mixture models identified multiple developmental trajectories of ADHD symptoms. The initial phase of intervention placed children on more positive developmental trajectories for impulsivity and hyperactivity, demonstrating the potential for ADHD prevention in at-risk youth, but the SAFE Children booster had no additional effect on trajectory or change in ADHD indicators.

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.

Prevention of shoulder dystocia: A randomized controlled trial to evaluate an obstetric maneuver.

PubMed

Poujade, Olivier; Azria, Elie; Ceccaldi, Pierre-François; Davitian, Carine; Khater, Carine; Chatel, Paul; Pernin, Emilie; Aflak, Nizar; Koskas, Martin; Bourgeois-Moine, Agnès; Hamou-Plotkine, Laurence; Valentin, Morgane; Renner, Jean-Paul; Roy, Carine; Estellat, Candice; Luton, Dominique

2018-08-01

Shoulder dystocia is a major obstetric emergency defined as a failure of delivery of the fetal shoulder(s). This study evaluated whether an obstetric maneuver, the push back maneuver performed gently on the fetal head during delivery, could reduce the risk of shoulder dystocia. We performed a multicenter, randomized, single-blind trial to compare the push back maneuver with usual care in parturient women at term. The primary outcome, shoulder dystocia, was considered to have occurred if, after delivery of the fetal head, any additional obstetric maneuver, beginning with the McRoberts maneuver, other than gentle downward traction and episiotomy was required. We randomly assigned 522 women to the push back maneuver group (group P) and 523 women to the standard vaginal delivery group (group S). Finally, 473 women assigned to group P and 472 women assigned to group S delivered vaginally. The rate of shoulder dystocia was significantly lower in group P (1·5%) than in group S (3·8%) (odds ratio [OR] 0·38 [0·16-0·92]; P = 0·03). After adjustment for predefined main risk factors, dystocia remained significantly lower in group P than in group S. There were no significant between-group differences in neonatal complications, including brachial plexus injury, clavicle fracture, hematoma and generalized asphyxia. In this trial in 945 women who delivered vaginally, the push back maneuver significantly decreased the risk of shoulder dystocia, as compared with standard vaginal delivery. Copyright © 2018 Elsevier B.V. All rights reserved.

Phenobarbitone versus phenytoin for treatment of neonatal seizures: an open-label randomized controlled trial.

PubMed

Pathak, Garima; Upadhyay, Amit; Pathak, Umesh; Chawla, Deepak; Goel, Sneh P

2013-08-01

To compare the efficacy of phenobarbitone and phenytoin for treatment of neonatal seizures in term and near-term neonates. Open labeled randomized controlled trial. Neonatal intensive care unit of a level II unit from India, from November 2008 to September 2009. All term and late pre-term neonates admitted with clinically apparent seizures and not having any transient metabolic disorders (hypoglycemia or hypocalcemia) were randomly assigned. Phenobarbitone (n=54) or phenytoin (n=55) intravenously 20 mg/kg/dose over 20-30 min. Neonates whose seizures were not controlled by the assigned drug were then crossed over to be treated with other drug in same dose. Clinical control of seizures (seizure free period of 24 hours after giving anticonvulsant). Baseline characteristics including mean birthweight, gestation age and sex were comparable in both groups. Seizures were controlled in 8 of the 55 (14.5%) neonates who received phenytoin, as compared to 39 of 54 (72.2%) neonates who received phenobarbitone (P <0.001). In babies not responding to assigned drugs, after cross-over to the other drug, seizure control was achieved in 44/55 (80%) of the neonates assigned to receive phenytoin first as compared to 49/54 (91%) of those assigned to receive phenobarbitone first (P=0.014). After maximum dose of phenobarbitone seizures were controlled in 49/55(89%) in phenytoin group and 52/54 (96%) in phenobarbitone group (P<0.05). Phenobarbitone is more efficacious than phenytoin in control of clinical seizures in term or near-term neonates, irrespective of etiology. To evaluate serum vascular endothelial growth factor (VEGF) levels in children with acute lymphoblastic leukemia (ALL) during the induction phase of chemotherapy.

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…

Improving the Short-Term Affect of Grieving Children through Art

ERIC Educational Resources Information Center

Hill, Kaylin E.; Lineweaver, Tara T.

2016-01-01

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

Genotype x Nutritional Environment Interaction in a Composite Beef Cattle Breed

USDA-ARS?s Scientific Manuscript database

Environmental effects have been shown to influence several economically important traits in beef cattle. In this study, genetic x nutritional environment interaction has been evaluated in a composite beef cattle breed(50% Red Angus, 25% Charolais, 25% Tarentaise).Cows were randomly assigned to be fe...

Study of Teaching Residents How to Teach.

ERIC Educational Resources Information Center

Edwards, Janine C.; And Others

1988-01-01

The effectiveness of a teaching skills program for residents at Louisiana State University Medical Center was evaluated among 22 residents in obstetrics and gynecology, medicine, and family medicine who were randomly assigned to control and experimental groups. There was greater increase in the scores of the experimental than the control groups.…

Cognitive-Behavioral Therapy for Pathological Gamblers

ERIC Educational Resources Information Center

Petry, Nancy M.; Ammerman, Yola; Bohl, Jaime; Doersch, Anne; Gay, Heather; Kadden, Ronald; Molina, Cheryl; Steinberg, Karen

2006-01-01

Few studies have evaluated efficacy of psychotherapies for pathological gambling. Pathological gamblers (N = 231) were randomly assigned to (a) referral to Gamblers Anonymous (GA), (b) GA referral plus a cognitive-behavioral (CB) workbook, or (c) GA referral plus 8 sessions of individual CB therapy. Gambling and related problems were assessed…

Green Tea Catechin Consumption Enhances Exercise-Induced Abdominal Fat Loss

USDA-ARS?s Scientific Manuscript database

Aim: This study evaluated the influence of a green tea catechin beverage on body composition and fat distribution in overweight and obese adults during exercised-induced weight loss. Methods: Participants (N=132) were randomly assigned to receive a 500 mL beverage containing approximately 625 mg of...

Does Early Reading Failure Decrease Children's Reading Motivation?

ERIC Educational Resources Information Center

Morgan, Paul L.; Fuchs, Douglas; Compton, Donald L.; Cordray, David S.; Fuchs, Lynn S.

2008-01-01

The authors used a pretest-posttest control group design with random assignment to evaluate whether early reading failure decreases children's motivation to practice reading. First, they investigated whether 60 first-grade children would report substantially different levels of interest in reading as a function of their relative success or failure…

A Referential Communication Demonstration versus a Lecture-Only Control: Learning Benefits

ERIC Educational Resources Information Center

Balch, William R.

2014-01-01

To evaluate a demonstration involving active and cooperative learning, 40 students in a cognitive psychology course and 132 students in an introductory psychology course completed a brief multiple-choice pretest on referential communication. Two days later, randomly assigned students either participated in a classroom referential communication…

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…

Couple-Focused Group Intervention for Women With Early Stage Breast Cancer

ERIC Educational Resources Information Center

Manne, Sharon L.; Ostroff, Jamie S.; Winkel, Gary; Fox, Kevin; Grana, Generosa; Miller, Eric; Ross, Stephanie; Frazier, Thomas

2005-01-01

This study examined the efficacy of a couple-focused group intervention on psychological adaptation of women with early stage breast cancer and evaluated whether perceived partner unsupportive behavior or patient functional impairment moderated intervention effects. Two hundred thirty-eight women were randomly assigned to receive either 6 sessions…

Internet-Based Treatment for Insomnia: A Controlled Evaluation

ERIC Educational Resources Information Center

Strom, Lars; Pettersson, Richard; Andersson, Gerhard

2004-01-01

This study investigated the effects of an Internet-based intervention for insomnia. Participants who met criteria for insomnia (N = 109) were randomly assigned to either a cognitive-behavioral self-help treatment or a waiting list control condition. The 5-week intervention mainly consisted of sleep restriction, stimulus control, and cognitive…

An Efficacious Theory-Based Intervention for Stepfamilies

ERIC Educational Resources Information Center

Forgatch, Marion S.; DeGarmo, David S.; Beldavs, Zintars G.

2005-01-01

This article evaluates the efficacy of the Oregon model of Parent Management Training (PMTO) in the stepfamily context. Sixty-seven of 110 participants in the Marriage and Parenting in Stepfamilies (MAPS) program received a PMTO-based intervention. Participants in the randomly assigned experimental group displayed a large effect in benefits to…

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…

77 FR 69812 - Agency Information Collection Activities; Comment Request; DC Choice Evaluation

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-21

... oversubscribed. The study will include the administration of annual academic assessments and surveys of students... randomized control trial comparing outcomes of eligible applicants (students and their parents) assigned by lottery to receive or not receive a scholarship. This design is consistent with the requirement for a...

Mastery, Maladaptive Learning Behaviour, and Academic Achievement: An Intervention Approach

ERIC Educational Resources Information Center

Ranellucci, John; Hall, Nathan; Muis, Krista; Lajoie, Susanne; Robinson, Kristy

2017-01-01

The effects of three interventions designed to boost academic achievement among mastery-oriented students were evaluated on interest-based studying, social desirability, and perceived goal difficulty. Undergraduate students (N = 177) completed relevant self-report measures at the beginning and the end of the semester and were randomly assigned to…

Depression in Adolescents with ASD: A Pilot RCT of a Group Intervention

ERIC Educational Resources Information Center

Santomauro, Damian; Sheffield, Jeanie; Sofronoff, Kate

2016-01-01

Depression is a potentially life threatening affective disorder that is highly prevalent in individuals with autism spectrum disorders (ASD). This study aimed to evaluate the feasibility, acceptability and preliminary efficacy of a cognitive behavioural intervention for depression in adolescents with ASD. Participants were randomly assigned to the…

Marathon Group Therapy with Female Narcotic Addicts.

ERIC Educational Resources Information Center

Kilmann, Peter R.

This study evaluated the impact of structured and unstructured marathon therapy on institutionalized female narcotic addicts. Subjects were randomly assigned to one of five groups: two structured therapy groups, two unstructured therapy groups, and a no-treatment control group. The Personal Orientation Inventory, the Adjective Check List, and a…

Improving Mathematics Learning of Kindergarten Students through Computer-Assisted Instruction

ERIC Educational Resources Information Center

Foster, Matthew E.; Anthony, Jason L.; Clements, Doug H.; Sarama, Julie; Williams, Jeffrey M.

2016-01-01

This study evaluated the effects of a mathematics software program, the Building Blocks software suite, on young children's mathematics performance. Participants included 247 Kindergartners from 37 classrooms in 9 schools located in low-income communities. Children within classrooms were randomly assigned to receive 21 weeks of computer-assisted…

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…

A Random Assignment Evaluation of Learning Communities Seven Years Later: Impacts on Education and Earnings Outcomes

ERIC Educational Resources Information Center

Weiss, Michael J.; Mayer, Alexander; Cullinan, Dan; Ratledge, Alyssa; Sommo, Colleen; Diamond, John

2014-01-01

Empirical evidence confirms that increased education is positively associated with higher earnings across a wide spectrum of fields and student demographics (Barrow & Rouse, 2005; Card, 2001; Carneiro, Heckman, & Vytlacil, 2011; Dadgar & Weiss, 2012; Dynarski, 2008; Jacobson & Mokher, 2009; Jepsen, Troske, & Coomes, 2009; Kane…

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…

Preference option randomized design (PORD) for comparative effectiveness research: Statistical power for testing comparative effect, preference effect, selection effect, intent-to-treat effect, and overall effect.

PubMed

Heo, Moonseong; Meissner, Paul; Litwin, Alain H; Arnsten, Julia H; McKee, M Diane; Karasz, Alison; McKinley, Paula; Rehm, Colin D; Chambers, Earle C; Yeh, Ming-Chin; Wylie-Rosett, Judith

2017-01-01

Comparative effectiveness research trials in real-world settings may require participants to choose between preferred intervention options. A randomized clinical trial with parallel experimental and control arms is straightforward and regarded as a gold standard design, but by design it forces and anticipates the participants to comply with a randomly assigned intervention regardless of their preference. Therefore, the randomized clinical trial may impose impractical limitations when planning comparative effectiveness research trials. To accommodate participants' preference if they are expressed, and to maintain randomization, we propose an alternative design that allows participants' preference after randomization, which we call a "preference option randomized design (PORD)". In contrast to other preference designs, which ask whether or not participants consent to the assigned intervention after randomization, the crucial feature of preference option randomized design is its unique informed consent process before randomization. Specifically, the preference option randomized design consent process informs participants that they can opt out and switch to the other intervention only if after randomization they actively express the desire to do so. Participants who do not independently express explicit alternate preference or assent to the randomly assigned intervention are considered to not have an alternate preference. In sum, preference option randomized design intends to maximize retention, minimize possibility of forced assignment for any participants, and to maintain randomization by allowing participants with no or equal preference to represent random assignments. This design scheme enables to define five effects that are interconnected with each other through common design parameters-comparative, preference, selection, intent-to-treat, and overall/as-treated-to collectively guide decision making between interventions. Statistical power functions for testing all these effects are derived, and simulations verified the validity of the power functions under normal and binomial distributions.

Pressure ulcer prevention: a randomized controlled trial of 2 risk-directed strategies for patient surface assignment.

PubMed

Inman, K J; Dymock, K; Fysh, N; Robbins, B; Rutledge, F S; Sibbald, W J

1999-03-01

To compare the clinical utility, in terms of incidence of pressure ulcer (PU) development, and economic impact of 2 programs of patient surface assignment for PU prevention. Randomized controlled clinical trial with economic evaluation. 30-bed multidisciplinary intensive care unit (ICU), serving as the regional trauma center. 144 consecutive eligible patients at risk for the development of PUs. PU risk was assessed on admission using the Skin Ulcer Risk Evaluation (SURE) Score, and patients were randomized to either the experimental (purchase) or control group (purchase/rent). Based on their SURE Score, patients were assigned a specialty surface if needed. Patients received head-to-toe skin assessments twice weekly, new PUs were documented, a new SURE Score was calculated, and specialty surfaces were upgraded or downgraded as necessary. The incidence of PUs by site and severity, and cost. Multivariate logistic regression and decision modeling. No significant differences were detected between groups with respect to baseline population characteristics, nor in the development of PUs. Predictors of PU development were ICU length of stay and SURE Score. The experimental (purchase) group was the less costly strategy. Under baseline assumptions, surface costs per at-risk patient were $76 CDN and $171 CDN in the experimental and control groups, respectively. The savings of $95 CDN per at-risk patient translates into conservative annual savings of $47,500 CDN. Using an objective, risk-based method of patient surface assignment, the authors compared the clinical and economic outcomes of 2 programs of PU prevention. In a direct comparison of alternatives, the strategy that emphasized purchased rather than rented products proved to be the more economical. Finally, this approach illustrates how by prospectively capturing data on both the costs and consequences of competing alternatives, a more objective and informed decision-making process can result.

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

Critical evaluation of the usability of augmented reality ophthalmoscopy for the training of inexperienced examiners.

PubMed

Leitritz, Martin A; Ziemssen, Focke; Suesskind, Daniela; Partsch, Michael; Voykov, Bogomil; Bartz-Schmidt, Karl U; Szurman, Gesine B

2014-04-01

To measure the value of augmented reality technology usage to teach the medical students performing binocular indirect ophthalmoscopy. Thirty-seven medical students were randomly assigned to the training of binocular indirect ophthalmoscopy either in the conventional way or with augmented reality ophthalmoscopy (ARO). For testing student's skills, they had to examine a real person using a conventional ophthalmoscopy system and draw the optic disk. They also had to fill out a questionnaire. Subjective and objective evaluations were performed. Thirty-seven students were randomly assigned to two groups. Eighteen students were trained with conventional ophthalmoscopy and 19 students with ARO. The questionnaires showed no differences. Performing an objective analysis, the median ophthalmoscopy training score for the conventional ophthalmoscopy group was 1.2 (range, 0.67-2) and showed a significant difference (P < 0.0033) to the ARO group (median 2; range, 0.67-2). The study provides evidence that a single ARO training is efficient to improve ophthalmoscopy skills. As the objective analysis showed, the ARO group had a significantly superior performance. Our study also indicates that subjective evaluation of the fundus drawings without systematic analysis is prone to errors.

[Parodontocid efficiency in complex treatment and prevention of gingivitis].

PubMed

Makeeva, I M; Turkina, A Iu; Poliakova, M A; Babina, K S

2013-01-01

Antiplaque/antigingivitis effect of an alcohol-free mouthrinse Parodontocid were evaluated by randomized parallel group clinical trial. Sixty patients with gingivitis were clinically examined to determine PHP, RMNPI and PMA indexes. After professional dental prophylaxis, subjects were randomly assigned in two groups to 10 days oral hygiene program. Group 1 patients used only toothbrush and prophylactic toothpaste while in group 2 persons used Parodontocid in conjunction with normal brushing and flossing.Parodontocid significantly reduced plaque and gingivitis compared to negative control.

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…

Introductory Statistics Students' Conceptual Understanding of Study Design and Conclusions

NASA Astrophysics Data System (ADS)

Fry, Elizabeth Brondos

Recommended learning goals for students in introductory statistics courses include the ability to recognize and explain the key role of randomness in designing studies and in drawing conclusions from those studies involving generalizations to a population or causal claims (GAISE College Report ASA Revision Committee, 2016). The purpose of this study was to explore introductory statistics students' understanding of the distinct roles that random sampling and random assignment play in study design and the conclusions that can be made from each. A study design unit lasting two and a half weeks was designed and implemented in four sections of an undergraduate introductory statistics course based on modeling and simulation. The research question that this study attempted to answer is: How does introductory statistics students' conceptual understanding of study design and conclusions (in particular, unbiased estimation and establishing causation) change after participating in a learning intervention designed to promote conceptual change in these areas? In order to answer this research question, a forced-choice assessment called the Inferences from Design Assessment (IDEA) was developed as a pretest and posttest, along with two open-ended assignments, a group quiz and a lab assignment. Quantitative analysis of IDEA results and qualitative analysis of the group quiz and lab assignment revealed that overall, students' mastery of study design concepts significantly increased after the unit, and the great majority of students successfully made the appropriate connections between random sampling and generalization, and between random assignment and causal claims. However, a small, but noticeable portion of students continued to demonstrate misunderstandings, such as confusion between random sampling and random assignment.

Treatment of reducible unstable fractures of the distal radius: randomized clinical study comparing the locked volar plate and external fixator methods: study protocol.

PubMed

Raduan Neto, Jorge; de Moraes, Vinicius Ynoe; Gomes Dos Santos, João B; Faloppa, Flávio; Belloti, João Carlos

2014-03-05

Various treatments are available for reducible unstable fractures of the distal radius, such as closed reduction combined with fixation by external fixator (EF), and rigid internal fixation using a locked volar plate (VP). Although there are studies comparing these methods, there is no conclusive evidence indicating which treatment is best. The hypothesis of this study is that surgical treatment with a VP is more effective than EF from the standpoint of functional outcome (patient-reported). The study is randomized clinical trial with parallel groups and a blinded evaluator and involves the surgical interventions EF and VP. Patients will be randomly assigned (assignment ratio 1:1) using sealed opaque envelopes. This trial will include consecutive adult patients with an acute (up to 15 days) displaced, unstable fracture of the distal end of the radius of type A2, A3, C1, C2 or C3 by the Arbeitsgemeinschaft für Osteosynthesefragen-Association for the Study of Internal Fixation classification and type II or type III by the IDEAL32 classification, without previous surgical treatments of the wrist. The surgical intervention assigned will be performed by three surgical specialists familiar with the techniques described. Evaluations will be performed at 2, and 8 weeks, 3, 6 and 12 months, with the primary outcomes being measured by the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and measurement of pain (Visual Analog Pain Scale and digital algometer). Secondary outcomes will include radiographic parameters, objective functional evaluation (goniometry and dynamometry), and the rate of complications and method failure according to the intention-to-treat principle. Final postoperative evaluations (6 and 12 months) will be performed by independent blinded evaluators. For the Student's t-test, a difference of 10 points in the DASH score, with a 95% confidence interval, a statistical power of 80%, and 20% sampling error results in 36 patients per group. Results from this study protocol will improve the current evidence regarding to the surgical treatment these fractures. ISCRTN09599740.

Biomarker analyses and final overall survival results from a phase III, randomized, open-label, first-line study of gefitinib versus carboplatin/paclitaxel in clinically selected patients with advanced non-small-cell lung cancer in Asia (IPASS).

PubMed

Fukuoka, Masahiro; Wu, Yi-Long; Thongprasert, Sumitra; Sunpaweravong, Patrapim; Leong, Swan-Swan; Sriuranpong, Virote; Chao, Tsu-Yi; Nakagawa, Kazuhiko; Chu, Da-Tong; Saijo, Nagahiro; Duffield, Emma L; Rukazenkov, Yuri; Speake, Georgina; Jiang, Haiyi; Armour, Alison A; To, Ka-Fai; Yang, James Chih-Hsin; Mok, Tony S K

2011-07-20

The results of the Iressa Pan-Asia Study (IPASS), which compared gefitinib and carboplatin/paclitaxel in previously untreated never-smokers and light ex-smokers with advanced pulmonary adenocarcinoma were published previously. This report presents overall survival (OS) and efficacy according to epidermal growth factor receptor (EGFR) biomarker status. In all, 1,217 patients were randomly assigned. Biomarkers analyzed were EGFR mutation (amplification mutation refractory system; 437 patients evaluable), EGFR gene copy number (fluorescent in situ hybridization; 406 patients evaluable), and EGFR protein expression (immunohistochemistry; 365 patients evaluable). OS analysis was performed at 78% maturity. A Cox proportional hazards model was used to assess biomarker status by randomly assigned treatment interactions for progression-free survival (PFS) and OS. OS (954 deaths) was similar for gefitinib and carboplatin/paclitaxel with no significant difference between treatments overall (hazard ratio [HR], 0.90; 95% CI, 0.79 to 1.02; P = .109) or in EGFR mutation-positive (HR, 1.00; 95% CI, 0.76 to 1.33; P = .990) or EGFR mutation-negative (HR, 1.18; 95% CI, 0.86 to 1.63; P = .309; treatment by EGFR mutation interaction P = .480) subgroups. A high proportion (64.3%) of EGFR mutation-positive patients randomly assigned to carboplatin/paclitaxel received subsequent EGFR tyrosine kinase inhibitors. PFS was significantly longer with gefitinib for patients whose tumors had both high EGFR gene copy number and EGFR mutation (HR, 0.48; 95% CI, 0.34 to 0.67) but significantly shorter when high EGFR gene copy number was not accompanied by EGFR mutation (HR, 3.85; 95% CI, 2.09 to 7.09). EGFR mutations are the strongest predictive biomarker for PFS and tumor response to first-line gefitinib versus carboplatin/paclitaxel. The predictive value of EGFR gene copy number was driven by coexisting EGFR mutation (post hoc analysis). Treatment-related differences observed for PFS in the EGFR mutation-positive subgroup were not apparent for OS. OS results were likely confounded by the high proportion of patients crossing over to the alternative treatment.

To evaluate the effectiveness of health care ethics consultation based on the goals of health care ethics consultation: a prospective cohort study with randomization.

PubMed

Chen, Yen-Yuan; Chu, Tzong-Shinn; Kao, Yu-Hui; Tsai, Pi-Ru; Huang, Tien-Shang; Ko, Wen-Je

2014-01-03

The growing prevalence of health care ethics consultation (HCEC) services in the U.S. has been accompanied by an increase in calls for accountability and quality assurance, and for the debates surrounding why and how HCEC is evaluated. The objective of this study was to evaluate the effectiveness of HCEC as indicated by several novel outcome measurements in East Asian medical encounters. Patients with medical uncertainty or conflict regarding value-laden issues, and requests made by the attending physicians or nurses for HCEC from December 1, 2009 to April 30, 2012 were randomly assigned to the usual care group (UC group) and the intervention group (HCEC group). The patients in the HCEC group received HCEC conducted by an individual ethics consultant. Data analysis was based on the intention-to-treat principle. Mann-Whitney test and Chi-squared test were used depending on the scale of measurement. Thirty-three patients (53.23%) were randomly assigned to the HCEC group and 29 patients were randomly assigned to the UC group. Among the 33 patients in the HCEC group, two (6.06%) of them ultimately did not receive a HCEC service. Among the 29 patients in the UC group, four (13.79%) of them received a HCEC service. The survival rate at hospital discharge did not differ between the two groups. Patients in the HCEC group showed significant reductions in the entire ICU stay and entire hospital stay. HCEC significantly facilitated achieving the goal of medical care (p < .01). Furthermore, patients in the HCEC group had a shorter ICU stay and shorter hospital stay after the occurrence of medical uncertainty or conflict regarding value-laden issues than those in the UC group. Our findings demonstrated that HCEC were associated with reduced consumption of medical resources as indicated by shorter entire ICU stay, entire hospital stay, and shorter ICU and hospital stay after the occurrence of the medical uncertainty or conflict regarding value-laden issues. This study also showed that HCEC facilitated achieving a consensus regarding the goal of medical care, which conforms to the goal of HCEC.

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

Evaluating the Effects of a Systemic Intervention on First-Grade Teachers' Explicit Reading Instruction

ERIC Educational Resources Information Center

Nelson-Walker, Nancy J.; Fien, Hank; Kosty, Derek B.; Smolkowski, Keith; Smith, Jean Louise M.; Baker, Scott K.

2013-01-01

This article examines the efficacy of a multitiered systemic reading intervention for increasing the intensity and quality of explicit literacy instruction that teachers provide in first-grade classrooms. Schools ("j" = 16) were randomly assigned to the treatment or comparison condition. In both conditions, teachers ("i" = 42)…

Cognitive-Behavioral Depression Treatment for Mothers of Children with Attention-Deficit/Hyperactivity Disorder

ERIC Educational Resources Information Center

Chronis, Andrea M.; Gamble, Stephanie A.; Roberts, John E.; Pelham, William E., Jr.

2006-01-01

An adaptation of the Coping With Depression Course (CWDC) was evaluated in mothers of children with attention-deficit/hyperactivity disorder (ADHD), a population at risk for depression. Mothers were randomly assigned to receive the CWDC either immediately following an intensive summer treatment program targeting their child's behavior or after a…

Evaluating Psychosocial and Behavioral Mechanisms of Change in a Tailored Communication Intervention

ERIC Educational Resources Information Center

Elder, John P.; Ayala, Guadalupe X.; Slymen, Donald J.; Arredondo, Elva M.; Campbell, Nadia R.

2009-01-01

This study examined the impact of a tailored nutrition intervention at 3 and 6 months postintervention. In all, 357 Latinas were randomly assigned to one of three conditions: (1) a control condition comprised of previously developed Spanish language targeted materials, (2) tailored print materials, or (3) tailored print materials accompanied by…

Interpersonal Problem-Solving Skills Training in the Treatment of Self-Poisoning Patients.

ERIC Educational Resources Information Center

McLeavey, B. C.; And Others

1994-01-01

Evaluated the effectiveness of interpersonal problem-solving skills training (IPSST) for the treatment of self-poisoning patients. Subjects were assigned randomly either to IPSST or to a control treatment. Although both treatments reduced the number of presenting problems, the IPSST was more effective as determined by other outcome measures. (RJM)

40 CFR 79.61 - Vehicle emissions inhalation exposure guideline.

Code of Federal Regulations, 2013 CFR

2013-07-01

... of the mean weight for each sex. Animals shall be randomly assigned to treatment and control groups... the control group(s) depends on the type of study, number of biological end points used in the... evaluation of chronic effects. (v) A concurrent control group is required. This group shall be exposed to...

40 CFR 79.61 - Vehicle emissions inhalation exposure guideline.

Code of Federal Regulations, 2012 CFR

2012-07-01

... of the mean weight for each sex. Animals shall be randomly assigned to treatment and control groups... the control group(s) depends on the type of study, number of biological end points used in the... evaluation of chronic effects. (v) A concurrent control group is required. This group shall be exposed to...

Combined Modality Intervention for ADHD with Comorbid Reading Disorders: A Proof of Concept Study

ERIC Educational Resources Information Center

Tannock, Rosemary; Frijters, Jan C.; Martinussen, Rhonda; White, Erin Jacquelyn; Ickowicz, Abel; Benson, Nancy J.; Lovett, Maureen W.

2018-01-01

To evaluate the relative efficacy of two reading programs with and without adjunctive stimulant medication for children with attention-deficit/hyperactivity disorder and comorbid reading disorder (ADHD+RD). Sixty-five children (7-11 years in age) were assigned randomly to one of three intensive remedial academic programs (phonologically or…

Evaluation of Preparatory Measures for Coping with Anxiety Raised by Media Coverage of Terrorism

ERIC Educational Resources Information Center

Slone, Michelle; Shoshani, Anat

2006-01-01

This study examines effects of television broadcasts of terrorism on viewers' anxiety and raises suggestions for 2 intervention strategies to moderate elevated anxiety. Participants were 120 young Israeli adults randomly allocated to a terrorism or a nonterrorism television broadcast and assigned to 1 of 3 intervention conditions prior to…

Impact Evaluation of FACTS & Feelings: A Home-Based Video Sex Education Curriculum.

ERIC Educational Resources Information Center

Miller, Brent C.; And Others

1993-01-01

Families (n=548) with seventh- or eighth-grade adolescents were randomly assigned to receive videotape sex education curriculum including videos with mailed newsletters, videos without newsletters, or neither (control group). Found no significant effect of the program on key outcome variables of teenagers' sexual intentions or behaviors.…

Contingency Management Improves Abstinence and Quality of Life in Cocaine Abusers

ERIC Educational Resources Information Center

Petry, Nancy M.; Alessi, Sheila M.; Hanson, Tressa

2007-01-01

Contingency management (CM) treatments enhance drug abstinence. This study evaluated whether CM also improves quality of life and if these effects are mediated by abstinence. Across 3 independent trials, cocaine abusers in intensive outpatient treatment (n = 387) were randomly assigned to 12 weeks of standard treatment as usual or standard…

"Project ACTS": An Intervention to Increase Organ and Tissue Donation Intentions among African Americans

ERIC Educational Resources Information Center

Arriola, Kimberly; Robinson, Dana H.; Thompson, Nancy J.; Perryman, Jennie P.

2010-01-01

This study sought to evaluate the effectiveness of "Project ACTS: About Choices in Transplantation and Sharing," which was developed to increase readiness for organ and tissue donation among African American adults. Nine churches (N = 425 participants) were randomly assigned to receive donation education materials currently available to consumers…

Distributional Analysis in Educational Evaluation: A Case Study from the New York City Voucher Program

ERIC Educational Resources Information Center

Bitler, Marianne; Domina, Thurston; Penner, Emily; Hoynes, Hilary

2015-01-01

We use quantile treatment effects estimation to examine the consequences of the random-assignment New York City School Choice Scholarship Program across the distribution of student achievement. Our analyses suggest that the program had negligible and statistically insignificant effects across the skill distribution. In addition to contributing to…

Attributional Retraining, Self-Esteem, and the Job Interview: Benefits and Risks for College Student Employment

ERIC Educational Resources Information Center

Hall, Nathan C.; Jackson Gradt, Shannan E.; Goetz, Thomas; Musu-Gillette, Lauren E.

2011-01-01

The present study evaluated the effectiveness of an attributional retraining program for helping upper-level undergraduates perform better in employment interviews as moderated by self-esteem levels. The sample consisted of 50 co-operative education students preparing for actual job interviews who were randomly assigned to an attributional…

Evaluation of an Anger Therapy Intervention for Incarcerated Adult Males

ERIC Educational Resources Information Center

Vannoy, Steven D.; Hoyt, William T.

2004-01-01

An anger therapy intervention was developed for incarcerated adult males. The therapy was an extension of cognitive-behavioral approaches, incorporating principles and practices drawn from Buddhist psychology. Adult males from a Midwestern low-security prison were randomly assigned to either a treatment group (n= 16) or a waiting list control…

Are Written Instructions Enough? Efficacy of Male Condom Packaging Leaflets among College Students

ERIC Educational Resources Information Center

Lindemann, Dana F.; Harbke, Colin R.

2013-01-01

Objective: To evaluate whether or not written condom use instructions successfully inform correct condom use skills. Design: Between-subjects, two-group design. Setting: Public university located in rural Midwestern region of the United States. Method: Participants were randomly assigned to either a control condition (read physical exercise…

Yeast supplementation altered the metabolic response to a combined viral-bacterial challenge in feedlot heifers

USDA-ARS?s Scientific Manuscript database

Two treatments were evaluated in feedlot heifers to determine the effects of feeding a yeast supplement on metabolic responses to a combined viral-bacterial respiratory disease challenge. Thirty-two beef heifers (325 +/- 19.2 kg) were selected and randomly assigned to one of two treatments: 1) Contr...

School Nurse Online Emergency Preparedness Training: An Analysis of Knowledge, Skills, and Confidence

ERIC Educational Resources Information Center

Elgie, Robert; Sapien, Robert; Fullerton, Lynne; Moore, Brian

2010-01-01

The objective of this study was to evaluate the effectiveness of a computer-assisted emergency preparedness course for school nurses. Participants from a convenience sample (52) of school nurses from New Mexico were randomly assigned to intervention or control groups in an experimental after-only posttest design. Intervention group participants…

Mediation and Moderation of Psychological Pain Treatments: Response Expectancies and Hypnotic Suggestibility

ERIC Educational Resources Information Center

Milling, Leonard S.; Reardon, John M.; Carosella, Gina M.

2006-01-01

The mediator role of response expectancies and the moderator role of hypnotic suggestibility were evaluated in the analogue treatment of pain. Approximately 1,000 participants were assessed for hypnotic suggestibility. Later, as part of a seemingly unrelated experiment, 188 of these individuals were randomly assigned to distraction,…

The Effects of Personal Construct Group Therapy on Breast Cancer Survivors

ERIC Educational Resources Information Center

Lane, Lisbeth G.; Viney, Linda L.

2005-01-01

In this study, the authors evaluated the effects of a brief personal construct group therapy on breast cancer survivors (N = 42) randomly assigned to either the treatment or wait-list control condition. The Gottschalk Gleser Content Analysis Scales were used to measure the effects for group across time (preand posttreatment, pretreatment, and…

The Evaluation of Four Mind/Body Intervention Strategies to Reduce Perceived Stress among College Students

ERIC Educational Resources Information Center

Winterdyk, John; Ray, Heather; Lafave, Lynne; Flessati, Sonya; Huston, Michael; Danelesko, Elaine; Murray, Christina

2008-01-01

We examined the effectiveness of four distinct mind/body interventions on reported perceived stress, anxiety, and health promoting behaviours in college students. Ninety students were randomly assigned to one of four experimental groups (i.e., nutritional, exercise, relaxation, or cognitive behavioural therapy). There were approximately 18…

"Touch Me, Like Me": Testing an Encounter Group Assumption

ERIC Educational Resources Information Center

Boderman, Alvin; And Others

1972-01-01

An experiment to test an encounter group assumption that touching increases interpersonal attraction was conducted. College women were randomly assigned to a touch or no-touch condition. A comparison of total evaluation scores verified the hypothesis: subjects who touched the accomplice perceived her as a more attractive person than those who did…

Outcomes of Parent Education Programs Based on Reevaluation Counseling

ERIC Educational Resources Information Center

Wolfe, Randi B.; Hirsch, Barton J.

2003-01-01

We report two studies in which a parent education program based on Reevaluation Counseling was field-tested on mothers randomly assigned to treatment groups or equivalent, no-treatment comparison groups. The goal was to evaluate the program's viability, whether there were measurable effects, whether those effects were sustained over time, and…

Serving Bowl Selection Biases the Amount of Food Served

ERIC Educational Resources Information Center

van Kleef, Ellen; Shimizu, Mitsuru; Wansink, Brian

2012-01-01

Objective: To determine how common serving bowls containing food for multiple persons influence serving behavior and consumption and whether they do so independently of satiation and food evaluation. Methods: In this between-subjects experiment, 68 participants were randomly assigned to either a group serving pasta from a large-sized bowl (6.9-L…

Fostering First Graders' Reasoning Strategies with Basic Sums: The Value of Guided Instruction

ERIC Educational Resources Information Center

Purpura, David J.; Baroody, Arthur J.; Eiland, Michael D.; Reid, Erin E.

2016-01-01

An intervention experiment served to evaluate the efficacy of highly guided discovery learning of relations underlying add-1 and doubles combination families and to compare the impact of such instruction with minimally guided instruction. After a pretest, 78 first graders were randomly assigned to one of three intervention conditions: highly…

Accelerated Desensitization with Adaptive Attitudes and Test Gains with 5th Graders

ERIC Educational Resources Information Center

Miller, Melanie; Morton, Jerome; Driscoll, Richard; Davis, Kai A.

2006-01-01

The study evaluates an easily-administered test-anxiety reduction program. An entire fifth grade was screened, and 36 students identified as test-anxious were randomly assigned to an Intervention or a non-participant Control group. The intervention was an accelerated desensitization and adaptive attitudes (ADAA) treatment which involved…

An Evaluation of a Media Literacy Program Training Workshop for Late Elementary School Teachers

ERIC Educational Resources Information Center

Scull, Tracy Marie; Kupersmidt, Janis Beth

2011-01-01

The present study examined the efficacy of a media literacy education, substance abuse prevention training workshop for late elementary school teachers. Analyses revealed that the randomly assigned intervention (n = 18) and control (n = 23) teachers were similar in demographic characteristics and pre-training beliefs and knowledge. Teachers who…

Computer versus In-Person Intervention for Students Violating Campus Alcohol Policy

ERIC Educational Resources Information Center

Carey, Kate B.; Henson, James M.; Carey, Michael P.; Maisto, Stephen A.

2009-01-01

In this study, the authors evaluated the efficacy of a brief motivational intervention (BMI) and a computerized program for reducing drinking and related problems among college students sanctioned for alcohol violations. Referred students (N = 198, 46% women), stratified by gender, were randomly assigned to a BMI or to the Alcohol 101 Plus…

The Effects of Reduced Cigarette Smoking on Discounting Future Rewards: An Initial Evaluation

ERIC Educational Resources Information Center

Yi, Richard; Johnson, Matthew W.; Giordano, Louis A.; Landes, Reid D.; Badger, Gary J.; Bickel, Warren K.

2008-01-01

To determine whether reduction of smoking via contingency management in dependent smokers would decrease the discounting of delayed reinforcers compared with smokers who did not reduce their smoking, moderate to heavy cigarette smokers were randomly assigned to one of two conditions: a contingency management condition and a control condition. In…

Results and Implications of a Problem-Solving Treatment Program for Obesity.

ERIC Educational Resources Information Center

Mahoney, B. K.; And Others

Data are from a large scale experimental study which was designed to evaluate a multimethod problem solving approach to obesity. Obese adult volunteers (N=90) were randomly assigned to three groups: maximal treatment, minimal treatment, and no treatment control. In the two treatment groups, subjects were exposed to bibliographic material and…

Utilization of rye as energy source affects bacterial translocation, intestinal viscosity, microbiota composition, and bone mineralization in broiler chickens

USDA-ARS?s Scientific Manuscript database

Two independent trials were conducted to evaluate the effect of two different dietary cereal types, corn versus rye, on digesta viscosity, gut integrity, and gut microbiota composition in commercial broiler chickens. In each experiment, day-of-hatch, off-sex broiler chickens were randomly assigned ...

Why Are Economists Evaluating the Impact of Gifted Education?

ERIC Educational Resources Information Center

Kettler, Todd

2016-01-01

Bui, Craig, and Imberman assessed the impact of gifted and talented programs on student achievement using regression discontinuity and random assignment to gifted magnet schools. In both analyses, they found minimal impact of the gifted and talented programs on student achievement. This commentary addresses two concerns associated with the study.…

Evaluation of a Cardio Pulmonary Resuscitation Curriculum for Junior and Senior High School Students.

ERIC Educational Resources Information Center

Vanderschmidt, Hannelore Falk

An adaptation of the standard American Heart Association training program was utilized to teach secondary school students cardiopulmonary Resuscitation (CPR) procedures. Students, at both junior and senior high levels, were randomly assigned to practice and no-practice groups, of ten students each. All were taught CPR procedures didactically, but…

Effects of an Informational Text Reading Comprehension Intervention for Fifth-Grade Students

ERIC Educational Resources Information Center

Ritchey, Kristen D.; Palombo, Kimberly; Silverman, Rebecca D.; Speece, Deborah L.

2017-01-01

Upper elementary school students who have reading problems may have difficulty in one or more areas of reading, each requiring specific types of interventions. This study evaluated a short-term reading intervention for 46 fifth-grade students with poor reading comprehension. Students were randomly assigned to an intervention or no treatment…

Prevention of Potential Falls of Elderly Healthy Women: Gait Asymmetry

ERIC Educational Resources Information Center

Seo, Jung-suk; Kim, Sukwon

2014-01-01

The study attempted to see if exercise training would alleviate gait asymmetry between nondominant and dominant legs, thus, eliminate the likelihood of slips. The present study provided 18 older adults exercise training for eight weeks and evaluated kinematics and ground reaction forces (GRFs) in both legs. Participants were randomly assigned to…

Studying the Effectiveness of an Online Language Learning Platform in China

ERIC Educational Resources Information Center

Baker, Ryan; Wang, Feng; Ma, Zhenjun; Ma, Wei; Zheng, Shiyue

2018-01-01

In this paper we evaluate the effectiveness of an adaptive online learning platform, designed to support Chinese students in learning the English language. The adaptive platform is studied in three studies, where the experimental platform is compared to an alternate, non-adaptive platform, with random assignment to conditions (the adaptive…

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.…

The Impact of Enhanced Incentives on Vocational Rehabilitation Outcomes for Dually Diagnosed Veterans

ERIC Educational Resources Information Center

Drebing, Charles E.; Van Ormer, E. Alice; Krebs, Christopher; Rosenheck, Robert; Rounsaville, Bruce; Herz, Lawrence; Penk, Walter

2005-01-01

This study evaluated the efficacy of adding contingency management techniques to vocational rehabilitation (VR) to improve treatment outcome as measured by entry into competitive employment. Nineteen dually diagnosed veterans who entered VR in the Veterans' Administration's compensated work therapy (CWT) program were randomly assigned to CWT (n =…

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

PubMed

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

2016-08-01

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

A Community-Based Randomized Trial of Hepatitis B Screening Among High-Risk Vietnamese Americans.

PubMed

Ma, Grace X; Fang, Carolyn Y; Seals, Brenda; Feng, Ziding; Tan, Yin; Siu, Philip; Yeh, Ming Chin; Golub, Sarit A; Nguyen, Minhhuyen T; Tran, Tam; Wang, Minqi

2017-03-01

To evaluate the effectiveness of a community-based liver cancer prevention program on hepatitis B virus (HBV) screening among low-income, underserved Vietnamese Americans at high risk. We conducted a cluster randomized trial involving 36 Vietnamese community-based organizations and 2337 participants in Pennsylvania, New Jersey, and New York City between 2009 and 2014. We randomly assigned 18 community-based organizations to a community-based multilevel HBV screening intervention (n = 1131). We randomly assigned the remaining 18 community-based organizations to a general cancer education program (n = 1206), which included information about HBV-related liver cancer prevention. We assessed HBV screening rates at 6-month follow-up. Intervention participants were significantly more likely to have undergone HBV screening (88.1%) than were control group participants (4.6%). In a Cochran-Mantel-Haenszel analysis, the intervention effect on screening outcomes remained statistically significant after adjustment for demographic and health care access variables, including income, having health insurance, having a regular health provider, and English proficiency. A community-based, culturally appropriate, multilevel HBV screening intervention effectively increases screening rates in a high-risk, hard-to-reach Vietnamese American population.

A Randomized, Controlled Trial of Intranasal Oxytocin as an Adjunct to Behavioral Therapy for Autism Spectrum Disorder

DTIC Science & Technology

2014-10-01

o Aude Henin, Ph.D. (MGH PI) o Dina Hirshfeld- Becker , Ph.D. (independent evaluator at MGH) o Angela Utschig, Ph.D. (study therapist at MGH) o...intranasal oxytocin or placebo. Participants and evaluators will be blind to treatment condition. In year 1 of the study, we set up the study framework...experimental treatment, and OT before 12 sessions of CBT treatment. Volunteers (patients) and evaluators will be blind to condition assignment

Use of bibloc and monobloc oral appliances in obstructive sleep apnoea: a multicentre, randomized, blinded, parallel-group equivalence trial.

PubMed

Isacsson, Göran; Nohlert, Eva; Fransson, Anette M C; Bornefalk-Hermansson, Anna; Wiman Eriksson, Eva; Ortlieb, Eva; Trepp, Livia; Avdelius, Anna; Sturebrand, Magnus; Fodor, Clara; List, Thomas; Schumann, Mohamad; Tegelberg, Åke

2018-05-16

The clinical benefit of bibloc over monobloc appliances in treating obstructive sleep apnoea (OSA) has not been evaluated in randomized trials. We hypothesized that the two types of appliances are equally effective in treating OSA. To compare the efficacy of monobloc versus bibloc appliances in a short-term perspective. In this multicentre, randomized, blinded, controlled, parallel-group equivalence trial, patients with OSA were randomly assigned to use either a bibloc or a monobloc appliance. One-night respiratory polygraphy without respiratory support was performed at baseline, and participants were re-examined with the appliance in place at short-term follow-up. The primary outcome was the change in the apnoea-hypopnea index (AHI). An independent person prepared a randomization list and sealed envelopes. Evaluating dentist and the biomedical analysts who evaluated the polygraphy were blinded to the choice of therapy. Of 302 patients, 146 were randomly assigned to use the bibloc and 156 the monobloc device; 123 and 139 patients, respectively, were analysed as per protocol. The mean changes in AHI were -13.8 (95% confidence interval -16.1 to -11.5) in the bibloc group and -12.5 (-14.8 to -10.3) in the monobloc group. The difference of -1.3 (-4.5 to 1.9) was significant within the equivalence interval (P = 0.011; the greater of the two P values) and was confirmed by the intention-to-treat analysis (P = 0.001). The adverse events were of mild character and were experienced by similar percentages of patients in both groups (39 and 40 per cent for the bibloc and monobloc group, respectively). The study shows short-term results with a median time from commencing treatment to the evaluation visit of 56 days and long-term data on efficacy and harm are needed to be fully conclusive. In a short-term perspective, both appliances were equivalent in terms of their positive effects for treating OSA and caused adverse events of similar magnitude. Registered with ClinicalTrials.gov (#NCT02148510).

A test of geographic assignment using isotope tracers in feathers of known origin

USGS Publications Warehouse

Wunder, Michael B.; Kester, C.L.; Knopf, F.L.; Rye, R.O.

2005-01-01

We used feathers of known origin collected from across the breeding range of a migratory shorebird to test the use of isotope tracers for assigning breeding origins. We analyzed δD, δ13C, and δ15N in feathers from 75 mountain plover (Charadrius montanus) chicks sampled in 2001 and from 119 chicks sampled in 2002. We estimated parameters for continuous-response inverse regression models and for discrete-response Bayesian probability models from data for each year independently. We evaluated model predictions with both the training data and by using the alternate year as an independent test dataset. Our results provide weak support for modeling latitude and isotope values as monotonic functions of one another, especially when data are pooled over known sources of variation such as sample year or location. We were unable to make even qualitative statements, such as north versus south, about the likely origin of birds using both δD and δ13C in inverse regression models; results were no better than random assignment. Probability models provided better results and a more natural framework for the problem. Correct assignment rates were highest when considering all three isotopes in the probability framework, but the use of even a single isotope was better than random assignment. The method appears relatively robust to temporal effects and is most sensitive to the isotope discrimination gradients over which samples are taken. We offer that the problem of using isotope tracers to infer geographic origin is best framed as one of assignment, rather than prediction.

Direct-to-Consumer Marketing of Psychological Treatments: A Randomized Controlled Trial

PubMed Central

Gallo, Kaitlin P.; Comer, Jonathan S.; Barlow, David H.; Clarke, Roberta N.; Antony, Martin M.

2015-01-01

Objective Although direct-to-consumer (DTC) marketing of pharmacologic interventions is effective and common, similar approaches have yet to be evaluated in the promotion of psychological treatments (PTs). This is the first randomized controlled trial evaluating the potential of DTC marketing of PTs. Method Participants (N=344; 75.0% female, mean age=18.6, 48.5% non-Hispanic Caucasian) were randomly assigned to consume one of four extended commercial campaigns embedded within unrelated programming across 3 weeks. The four campaign conditions were: [1] PT campaign; [2] PT informing about Medication Side Effects campaign; [3] Medication campaign; and [4] Neutral campaign. Attitudes about and intention to seek psychological treatment were assessed prior to campaign exposure (T1), 1 week following the final week of campaign exposure (T2), and at a 3-month follow-up evaluation (T3). Results The percentage of participants who newly intended psychological treatment at T2 or T3 differed by condition, with those assigned to the PT campaign slightly more likely to have intended to receive psychological treatment at T2 or T3 than those in other conditions. Baseline reports of emotional symptoms moderated the effect of condition on attitudes toward PT and perceived likelihood of seeking treatment in the future. Conclusions Findings support the preliminary utility of DTC marketing of psychological treatments. Increasing consumer knowledge of PTs may be a worthwhile complement to current dissemination and implementation efforts aimed at promoting the uptake of PTs in mental health care. PMID:26098374

Direct-to-consumer marketing of psychological treatments: A randomized controlled trial.

PubMed

Gallo, Kaitlin P; Comer, Jonathan S; Barlow, David H; Clarke, Roberta N; Antony, Martin M

2015-10-01

Although direct-to-consumer (DTC) marketing of pharmacologic interventions is effective and common, similar approaches have yet to be evaluated in the promotion of psychological treatments (PTs). This is the first randomized controlled trial evaluating the potential of DTC marketing of PTs. Participants (N = 344; 75.0% female, mean age = 18.6 years, 48.5% non-Hispanic White) were randomly assigned to consume one of four extended commercial campaigns embedded within unrelated programming across 3 weeks. The four campaign conditions were a PT campaign, a PT informing about medication side effects campaign, a medication campaign, and a neutral campaign. Attitudes about and intention to seek psychological treatment were assessed prior to campaign exposure (T1), 1 week following the final week of campaign exposure (T2), and at a 3-month follow-up evaluation (T3). The percentage of participants who newly intended psychological treatment at T2 or T3 differed by condition, with those assigned to the PT campaign slightly more likely to have intended to receive psychological treatment at T2 or T3 than those in other conditions. Baseline reports of emotional symptoms moderated the effect of condition on attitudes toward PT and perceived likelihood of seeking treatment in the future. Findings support the preliminary utility of DTC marketing of psychological treatments. Increasing consumer knowledge of PTs may be a worthwhile complement to current dissemination and implementation efforts aimed at promoting the uptake of PTs in mental health care. (c) 2015 APA, all rights reserved).

Comparison of two surgical procedures for use of the acellular dermal matrix graft in the treatment of gingival recessions: a randomized controlled clinical study.

PubMed

Felipe, Maria Emília M C; Andrade, Patrícia F; Grisi, Marcio F M; Souza, Sérgio L S; Taba, Mário; Palioto, Daniela B; Novaes, Arthur B

2007-07-01

The aim of this randomized, controlled, clinical investigation was to compare two surgical techniques for root coverage with the acellular dermal matrix graft to evaluate which technique provided better root coverage, a better esthetic result, and less postoperative discomfort. Fifteen patients with bilateral Miller Class I or II gingival recessions were selected. Fifteen pairs of recessions were treated and assigned randomly to the test group, and the contralateral recessions were assigned to the control group. The control group was treated with a broader flap and vertical releasing incisions; the test group was treated with the proposed surgical technique, without vertical releasing incisions. The clinical parameters evaluated were probing depth, relative clinical attachment level, gingival recession (GR), width of keratinized tissue, thickness of keratinized tissue, esthetic result, and pain evaluation. The measurements were taken before the surgeries and after 6 months. At baseline, all parameters were similar for both groups. At 6 months, a statistically significant greater reduction in GR favored the control group. The percentage of root coverage was 68.98% and 84.81% for the test and control groups, respectively. The esthetic result was equivalent between the groups, and all patients tolerated both procedures well. Both techniques provided significant root coverage, good esthetic results, and similar levels of postoperative discomfort. However, the control technique had statistically significantly better results for root coverage of localized gingival recessions.

Hypnosis, suggestions, and altered states of consciousness: experimental evaluation of the new cognitive-behavioral theory and the traditional trance-state theory of "hypnosis".

PubMed

Barber, T X; Wilson, S C

1977-10-07

Sixty-six subjects were tested on a new scale for evaluating "hypnotic-like" experiences (The Creative Imagination Scale), which includes ten standardized test-suggestions (e.g. suggestions for arm heaviness, finger anesthesia, time distortion, and age regression). The subjects were randomly assigned to one of three treatment groups (Think-With Instructions, trance induction, and Control), with 22 subjects to each group. The new Cognitive-Behavioral Theory predicted that subjects exposed to preliminary instructions designed to demonstrate how to think and imagine along with the suggested themes (Think-With Instructions) would be more responsive to test-suggestions for anesthesia, time distortion, age regression, and so on, than subjects exposed to a trance-induction procedure. On the other hand, the traditional Trance State Theory predicted that a trance induction would be more effective than Think-With Instructions in enhancing responses to such suggestions. Subjects exposed to the Think-With Instructions obtained significantly higher scores on the test-suggestions than those exposed either to the traditional trance-induction procedure or to the control treatment. Scores of subjects who received the trance-induction procedure were not significantly different from those of the subjects who received the control treatment. The results thus supported the new Cognitive-Behavioral Theory and contradicted the traditional Trance State Theory of hypnosis. Two recent experiments, by De Stefano and by Katz, confirmed the above experimental results and offered further support for the Cognitive-Behavioral Theory. In both recent experiments, subjects randomly assigned to a "Think-With Instructions" treatment were more responsive to test-suggestions than those randomly assigned to a traditional trance-induction treatment.

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

A TAD better for myeloma therapy?

PubMed

Giralt, Sergio

2010-02-11

In this issue of Blood, Lokhorst and colleagues report on the results of HOVON-50, a phase 3 randomized trial designed to evaluate the effects of thalidomide during induction treatment and as maintenance in patients with multiple myeloma. There were 556 patients randomly assigned either to 3 cycles of VAD or to TAD. All patients were to receive high-dose melphalan with autologous stem cell support followed by maintenance with interferon for the VAD arm or thalidomide for the TAD arm.(1) This study together with other randomized and nonrandomized trials establish a definitive role for thalidomide as induction therapy in conjunction with dexamethasone, anthracyclines, and alkylating agents.

E-care: a telecommunications technology intervention for family caregivers of dementia patients.

PubMed

Finkel, Sanford; Czaja, Sara J; Schulz, Richard; Martinovich, Zoran; Harris, Carol; Pezzuto, Donna

2007-05-01

This study evaluated the effectiveness of a technology-based psychoeducational intervention for family caregivers of dementia patients. An additional objective was to determine if the intervention could be implemented by a community-based social service agency. Forty-six caregivers were randomly assigned to either a technology-based intervention or an information-only control condition. Caregivers assigned to the intervention condition reported a significant decrease in burden postintervention and those who evidenced high depression at baseline experienced a significant decline in depression. This study provides evidence that technology offers a cost-effective and practical method for delivering interventions to caregivers.

An Early Look at Families and Local Programs in the Mother and Infant Home Visiting Program Evaluation-Strong Start: Third Annual Report. OPRE Report 2016-37

ERIC Educational Resources Information Center

Lee, Helen; Crowne, Sarah; Faucetta, Kristen; Hughes, Rebecca

2016-01-01

The Mother and Infant Home Visiting Program Evaluation-Strong Start (MIHOPE-Strong Start) is the largest random assignment study to date to examine the effectiveness of home visiting services on improving birth outcomes and infant and maternal health care use for expectant mothers. The study includes local home visiting programs that use one of…

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…

Does a surgical simulator improve resident operative performance of laparoscopic tubal ligation?

PubMed

Banks, Erika H; Chudnoff, Scott; Karmin, Ira; Wang, Cuiling; Pardanani, Setul

2007-11-01

The purpose of this study was to assess whether a surgical skills simulator laboratory improves resident knowledge and operative performance of laparoscopic tubal ligation. Twenty postgraduate year 1 residents were assigned randomly to either a surgical simulator laboratory on laparoscopic tubal ligation together with apprenticeship teaching in the operating room or to apprenticeship teaching alone. Tests that were given before and after the training assessed basic knowledge. Attending physicians who were blinded to resident randomization status evaluated postgraduate year 1 performance on a laparoscopic tubal ligation in the operating room with 3 validated tools: a task-specific checklist, global rating scale, and pass/fail grade. Postgraduate year 1 residents who were assigned randomly to the surgical simulator laboratory performed significantly better than control subjects on all 3 surgical assessment tools (the checklist, the global score, and the pass/fail analysis) and scored significantly better on the knowledge posttest (all P < .0005). Compared with apprenticeship teaching alone, a surgical simulator laboratory on laparoscopic tubal ligation improved resident knowledge and performance in the operating room.

Long-Term Results of CCG 5942: A Randomized Comparison of Chemotherapy With and Without Radiotherapy for Children With Hodgkin's Lymphoma—A Report From the Children's Oncology Group

PubMed Central

Wolden, Suzanne L.; Chen, Lu; Kelly, Kara M.; Herzog, Philip; Gilchrist, Gerald S.; Thomson, John; Sposto, Richard; Kadin, Marshall E.; Hutchinson, Raymond J.; Nachman, James

2012-01-01

Purpose In 1995, the Children's Cancer Group (CCG) opened a trial for patients with Hodgkin's lymphoma evaluating whether low-dose involved-field radiation therapy (IFRT) improved event-free survival (EFS) for patients achieving a complete response after chemotherapy. We present the long-term study outcome using final data through March 2007. Patients and Methods Between January 1995 and December 1998, 826 eligible patients were enrolled onto CCG 5942. Four hundred ninety-eight patients achieving an initial complete response to chemotherapy were randomly assigned to receive IFRT or no further therapy. EFS and overall survival (OS) were assessed from the date of study entry or random assignment, as appropriate. Results Ten-year EFS and OS rates for the entire cohort were 83.5% and 92.5%, respectively. In an as-treated analysis for randomly assigned patients, the 10-year EFS and OS rates were 91.2% and 97.1%, respectively, for IFRT and 82.9% and 95.9%, respectively, for no further therapy. For EFS and OS comparisons, P = .004 and P = .50, respectively. Bulk disease, “B” symptoms, and nodular sclerosis histology were risk factors for inferior EFS. Conclusion With a median follow-up of 7.7 years, IFRT produced a statistically significant improvement in EFS but no improvement in OS. For individual patients, the relative risks of relapse versus late effects of IFRT must be considered. Patient and disease characteristics and early response assessment will aid in deciding which patients are most likely to benefit from IFRT. PMID:22649136

A randomized evaluation of smoking cessation interventions for pregnant women at a WIC clinic.

PubMed Central

Mayer, J P; Hawkins, B; Todd, R

1990-01-01

Pregnant smokers attending a local health department WIC clinic were randomly assigned to one of two self-help smoking cessation programs or usual care. The multiple component program resulted in larger quit rates than usual care during the last month of pregnancy (11 percent vs 3 percent) and postpartum (7 percent vs 0 percent). Achieving quit rates in WIC similar to those in studies conducted at prenatal care settings, suggests that smoking cessation programs for low-income pregnant WIC clients are feasible. PMID:2293809

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.

Can Schools Promote the Health of Children with Asthma?

ERIC Educational Resources Information Center

McWhirter, Jenny; McCann, Donna; Coleman, Helen; Calvert, Marguerite; Warner, John

2008-01-01

This report describes the evaluation of a whole-school intervention to improve morbidity and psychosocial well-being in pupils with asthma. In all, 193 children with asthma (7-9 years) from 23 primary/junior schools in the south of England participated. Schools (n = 12) randomly assigned to the intervention group (IV) received a staff asthma…

Caring for Others: Internet Video-Conferencing Group Intervention for Family Caregivers of Older Adults with Neurodegenerative Disease

ERIC Educational Resources Information Center

Marziali, Elsa; Donahue, Peter

2006-01-01

Purpose: The aim of this pilot feasibility study was to evaluate the effects of an innovative, Internet-based psychosocial intervention for family caregivers of older adults with neurodegenerative disease. Design and Methods: After receiving signed informed consent from each participant, we randomly assigned 66 caregivers to an Internet-based…

Evaluation of a Sexual Abuse Prevention Education for Chinese Preschoolers

ERIC Educational Resources Information Center

Zhang, Wenjing; Chen, Jingqi; Feng, Yanan; Li, Jingyi; Liu, Chengfeng; Zhao, Xiaoxia

2014-01-01

Objectives: The purpose of this study was to test the feasibility of a sexual abuse prevention education in a sample of Chinese preschool children in Beijing, China. Method: One hundred and fifty preschool children were randomly assigned to either the intervention group (N = 78) or the wait-list control group (N = 72). Children were posttested on…

Evaluation of the TSL® Program for Parents of Children with Cancer

ERIC Educational Resources Information Center

Choi, Kwonho; Kim, Jae Yop

2018-01-01

Objectives: This study aims to investigate the effects of the "Thank you-Sorry-Love" (TSL®) program on posttraumatic growth (PTG) and cortisol level in parents of children with cancer. Methods: A total of 15 mothers of children with cancer were randomly assigned to the experimental group (n = 7) with the TSL intervention or a control…

The Effects of Cuento Therapy on Reading Achievement and Psychological Outcomes of Mexican-American Students

ERIC Educational Resources Information Center

Ramirez, Sylvia Z.; Jain, Sachin; Flores-Torres, Leila L.; Perez, Roxanna; Carlson, Ralph

2009-01-01

This investigation evaluated the effects of cuento therapy (an intervention using Spanish-language tales) on children's self-esteem, affect, and reading test performance. The sample was composed of 58 third-grade Mexican-American students who were randomly assigned to the treatment and control groups. The results showed a mean self-esteem gain…

Measuring the Impact of Haptic Feedback Using the SOLO Taxonomy

ERIC Educational Resources Information Center

Minogue, James; Jones, Gail

2009-01-01

The application of Biggs' and Collis' Structure of Observed Learning Outcomes taxonomy in the evaluation of student learning about cell membrane transport via a computer-based learning environment is described in this study. Pre-test-post-test comparisons of student outcome data (n = 80) were made across two groups of randomly assigned students:…

Consultation-Based Academic Interventions for Children with ADHD: Effects on Reading and Mathematics Achievement

ERIC Educational Resources Information Center

DuPaul, George J.; Jitendra, Asha K.; Volpe, Robert J.; Tresco, Katy E.; Lutz, J. Gary; Vile Junod, Rosemary E.; Cleary, Kristi S.; Flammer, Lizette M.; Mannella, Mark C.

2006-01-01

The purpose of this investigation was to evaluate the relative efficacy of two consultation-based models for designing academic interventions to enhance the educational functioning of children with attention-deficit/hyperactivity disorder (ADHD). Children (N = 167) meeting DSM-IV criteria for ADHD were randomly assigned to one of two consultation…

An Experiment in the Evaluation of Instruction at the Junior College.

ERIC Educational Resources Information Center

Partridge, Patrick V.

This study was designed to determine the effectiveness of textbook and lecture methods of instruction on student achievement during 10 days of an introductory psychology course. The 48 subjects were randomly assigned to four treatment groups. The same examination was given as pretest and as post-test. The test was concerned with recall of factual…

Linking Implementation Process to Intervention Outcomes in a Middle School Obesity Prevention Curriculum, "Choice, Control and Change"

ERIC Educational Resources Information Center

Gray, Heewon Lee; Contento, Isobel R.; Koch, Pamela A.

2015-01-01

This study investigates the link between process evaluation components and the outcomes of a school-based nutrition curriculum intervention, "Choice, Control and Change". Ten New York City public middle schools were recruited and randomly assigned into intervention or control condition. The curriculum was to improve sixth to seventh…

Developing Low-Income Preschoolers' Social Studies and Science Vocabulary Knowledge through Content-Focused Shared Book Reading

ERIC Educational Resources Information Center

Gonzalez, Jorge E.; Pollard-Durodola, Sharolyn; Simmons, Deborah C.; Taylor, Aaron B.; Davis, Matthew J.; Kim, Minjun; Simmons, Leslie

2011-01-01

This study evaluated the effects of integrating science and social studies vocabulary instruction into shared book reading with low-income preschool children. Twenty-one preschool teachers and 148 children from their classrooms were randomly assigned at the class level to either the Words of Oral Reading and Language Development (WORLD)…

Experimental evaluation of the effect of winter feeding on channel catfish growout pond plankton

USDA-ARS?s Scientific Manuscript database

Ten, 0.25 acre ponds at the UAPB Aquaculture Station were sampled weekly from Dec. 7-Feb. 22 (n=90) for phytoplankton and zooplankton. Five of the ponds were randomly assigned to each of two treatments: no feeding and feeding based on recommended rates. Channel catfish sizes and numbers approximated...

Cost Effectiveness of Alcoholism Treatment in Partial Hospital versus Inpatient Settings After Brief Inpatient Treatment: 12-Month Outcomes.

ERIC Educational Resources Information Center

McCrady, Barbara; And Others

1986-01-01

Alcoholics (N=174) were randomly assigned to partial hospital treatment (PHT) or extended inpatient (EIP) rehabilitation after inpatient evaluation and/or detoxification. There were few differences in clinical outcomes between the PHT and EIP groups. Subjects showed significant improvements in psychological well-being and social behavior.…

Dietary supplementation of Allium hookeri improved intestinal immune response on necrotic enteritis of young broiler chickens

USDA-ARS?s Scientific Manuscript database

This study was conducted to evaluate the effects of dietary Allium hookeri (AH) root on host intestinal immune response in necrotic enteritis (NE)-afflicted young broiler chickens. Three hundred birds (one-day-old) were randomly assigned to 6 groups (n =50 birds/treatment) and fed with basal diet (c...

Acute immunological responses to a combined viral-bacterial respiratory disease challenge in feedlot heifers supplemented with yeast

USDA-ARS?s Scientific Manuscript database

Two treatments were evaluated in commercial feedlot heifers to determine the effects of a yeast supplement on immune responses to a combined viral-bacterial respiratory challenge. Thirty-two beef heifers (325 +/- 19.2 kg BW) were selected and randomly assigned to one of two treatments, and fed for 3...

Immediate and Short-Term Outcomes of the "COPEing with Toddler Behaviour" Parent Group

ERIC Educational Resources Information Center

Niccols, Alison

2009-01-01

Background: Controlling, uninvolved, and rejecting parenting in early childhood are strong predictors of later disruptive behavior disorders. However, there have been no evaluations of non-targeted groups for parents of very young children, despite their potential advantages. Methods: We randomly assigned 79 mothers of 12- to 36-month-olds to an…

For Which Children of Economic Disadvantage and in Which Instructional Contexts Does Earobics Step 1 Improve Kindergarteners' Literacy?

ERIC Educational Resources Information Center

Anthony, Jason L.

2016-01-01

This study evaluated Earobics Step 1, a commercial literacy program, and examined whether impact varied with children's school readiness and classroom instruction. Participants included 247 kindergarteners from 37 classrooms in nine Title 1 schools. Children were randomly assigned to receive 21 weeks of computerized instruction with Earobics or…

Maintenance of Gains Following Experiential Therapies for Depression

ERIC Educational Resources Information Center

Ellison, Jennifer A.; Greenberg, Leslie S.; Goldman, Rhonda N.; Angus, Lynne

2009-01-01

Follow-up data across an 18-month period are presented for 43 adults who had been randomly assigned and had responded to short-term client-centered (CC) and emotion-focused (EFT) therapies for major depression. Long-term effects of these short-term therapies were evaluated using relapse rates, number of asymptomatic or minimally symptomatic weeks,…

Structural Equation Modeling (SEM) for Satisfaction and Dissatisfaction Ratings; Multiple Group Invariance Analysis across Scales with Different Response Format

ERIC Educational Resources Information Center

Mazaheri, Mehrdad; Theuns, Peter

2009-01-01

The current study evaluates three hypothesized models on subjective well-being, comprising life domain ratings (LDR), overall satisfaction with life (OSWL), and overall dissatisfaction with life (ODWL), using structural equation modeling (SEM). A sample of 1,310 volunteering students, randomly assigned to six conditions, rated their overall life…

Using School Lotteries to Evaluate the Value-Added Model

ERIC Educational Resources Information Center

Deutsch, Jonah

2013-01-01

There has been an active debate in the literature over the validity of value-added models. In this study, the author tests the central assumption of value-added models that school assignment is random relative to expected test scores conditional on prior test scores, demographic variables, and other controls. He uses a Chicago charter school's…

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…

Alterations in the somatotrophic axis during an infectious bovine rhinotracheitis viral (IBRV) challenge in beef steers

USDA-ARS?s Scientific Manuscript database

To evaluate the effects IBRV has on immunological and physiological parameters of cattle, 12 Angus crossbred steers (228.82 ± 22.15 kg) were randomly assigned to either a Control group or an IBRV challenged group. Prior to the challenge steers were fitted with an indwelling rectal probe, BW were rec...

Evaluating the Impact of a Brief Artistic Intervention on Cardiovascular Recovery from Acute Stress

ERIC Educational Resources Information Center

Keogh, Katharina; Creaven, Ann-Marie

2017-01-01

In this study we tested whether drawing and coloring influence cardiovascular recovery and perceived stress following exposure to a stressor. In a mixed experimental design, participants (N = 62) completed an acute stress task before being randomly assigned to one of three brief activities: free-form drawing (full creative control), coloring…

Effect of reduced heifer nutrition during in utero and post-weaning development on glucose and acetate kinetics

USDA-ARS?s Scientific Manuscript database

Energetic efficiency was evaluated in composite heifers born from dams receiving one of two levels of winter supplementation and then at weaning randomly assigned to their own nutritional treatment of either control (CON; fed to appetite; n = 8/yr) or restricted (RES; fed 80% of that fed to controls...

Effectiveness of a Classroom Mindfulness Coloring Activity for Test Anxiety in Children

ERIC Educational Resources Information Center

Carsley, Dana; Heath, Nancy L.; Fajnerova, Sophia

2015-01-01

To evaluate the effectiveness of mindfulness-based structured versus unstructured coloring on test anxiety, 52 participants (53.8% female; M[subscript age] = 10.92 years, SD = 0.82) were randomly assigned to either a structured mandala (n = 26) or free coloring condition (n = 26), and completed a standardized anxiety measure to assess anxiety…

Fostering First Graders' Fluency with Basic Subtraction and Larger Addition Combinations via Computer-Assisted Instruction

ERIC Educational Resources Information Center

Baroody, Arthur J.; Purpura, David J.; Eiland, Michael D.; Reid, Erin E.

2014-01-01

Achieving fluency with basic subtraction and add-with-8 or -9 combinations is difficult for primary grade children. A 9-month training experiment entailed evaluating the efficacy of software designed to promote such fluency via guided learning of reasoning strategies. Seventy-five eligible first graders were randomly assigned to one of three…

Evaluation of a Decision-Making Curriculum for Teaching Adolescents with Disabilities to Resist Negative Peer Pressure

ERIC Educational Resources Information Center

Khemka, Ishita; Hickson, Linda; Mallory, Sarah B.

2016-01-01

This study was designed to assess the impact of a decision-making curriculum (PEER-DM) on the social peer relationship knowledge and self-protective decision-making skills of adolescents with disabilities in hypothetical situations involving negative peer pressure. A randomized design was used to assign students with disabilities from…

Assessing Women's Responses to Sexual Threat: Validity of a Virtual Role-Play Procedure

ERIC Educational Resources Information Center

Jouriles, Ernest N.; Rowe, Lorelei Simpson; McDonald, Renee; Platt, Cora G.; Gomez, Gabriella S.

2011-01-01

This study evaluated the validity of a role-play procedure that uses virtual reality technology to assess women's responses to sexual threat. Forty-eight female undergraduate students were randomly assigned to either a standard, face-to-face role-play (RP) or a virtual role-play (VRP) of a sexually coercive situation. A multimethod assessment…

Impact of Intensive Summer Reading Intervention for Children with Reading Disabilities and Difficulties in Early Elementary School

ERIC Educational Resources Information Center

Christodoulou, Joanna A.; Cyr, Abigail; Murtagh, Jack; Chang, Patricia; Lin, Jiayi; Guarino, Anthony J.; Hook, Pamela; Gabrieli, John D. E.

2017-01-01

Efficacy of an intensive reading intervention implemented during the nonacademic summer was evaluated in children with reading disabilities or difficulties (RD). Students (ages 6-9) were randomly assigned to receive Lindamood-Bell's "Seeing Stars" program (n = 23) as an intervention or to a waiting-list control group (n = 24). Analysis…

A Random Assignment Evaluation of Learning Communities at Kingsborough Community College--Seven Years Later

ERIC Educational Resources Information Center

Weiss, Michael J.; Mayer, Alexander K.; Cullinan, Dan; Ratledge, Alyssa; Sommo, Colleen; Diamond, John

2015-01-01

Community colleges play a vital role in higher education, enrolling more than one in every three postsecondary students. While their market share has grown over the past 50 years, students' success rates remain low. Consequently, community college stakeholders are searching with mounting urgency for strategies that increase rates of success. We…

A Random Assignment Evaluation of Learning Communities at Kingsborough Community College: Seven Years Later

ERIC Educational Resources Information Center

Weiss, Michael J.; Mayer, Alexander; Cullinan, Dan; Ratledge, Alyssa; Sommo, Colleen; Diamond, John

2014-01-01

Community colleges play a vital role in higher education, enrolling more than one in every three postsecondary students. While the market share of these institutions has grown over the past 50 years, students' success rates remain low. Consequently, community college stakeholders are searching with mounting urgency for strategies that increase…

Acute immunological responses to a combined viral-bacterial respiratory disease challenge in heifers administered transdermal flunixin meglumine

USDA-ARS?s Scientific Manuscript database

Time of flunixin meglumine transdermal (FTD; Finadyne Transdermal, Merck Animal Health, Summit, NJ) administration relative to a viral-bacterial challenge was evaluated in beef heifers. Thirty-two beef heifers (170 ± 21.1 kg BW) were randomly assigned to one of four treatments: 1) Control (CON), rec...

Does Comparing Solution Methods Facilitate Conceptual and Procedural Knowledge? An Experimental Study on Learning to Solve Equations

ERIC Educational Resources Information Center

Rittle-Johnson, Bethany; Star, Jon R.

2007-01-01

Encouraging students to share and compare solution methods is a key component of reform efforts in mathematics, and comparison is emerging as a fundamental learning mechanism. To experimentally evaluate the effects of comparison for mathematics learning, the authors randomly assigned 70 seventh-grade students to learn about algebra equation…

Zinc source and concentration altered physiological responses of beef heifers during a combined viral-bacterial respiratory challenge

USDA-ARS?s Scientific Manuscript database

Three treatments were evaluated in feedlot heifers to determine the effects of zinc supplementation on the immune response to a combined viral-bacterial respiratory disease challenge. Thirty-two beef heifers (255+/-15 kg) were subjected to a 30d period of Zn depletion, then randomly assigned to one ...

An Evaluation of Two Methods for Teaching United States History to Students with Learning Disabilities

ERIC Educational Resources Information Center

Winchester, Katherine; Darch, Craig; Eaves, Ronald C.; Shippen, Margaret E.; Ern, Greg; Bell, Bedarius

2009-01-01

We compared two approaches to teaching United States history to students with learning disabilities (LD). We randomly assigned students in seventh through ninth grades (n = 44) to separate treatment groups (strategy-based instruction or traditional instruction). In both approaches, students were taught identical content on two units of the Civil…

Gender Gaps in College Enrollment: The Role of Gender Sorting across Public High Schools

ERIC Educational Resources Information Center

Conger, Dylan; Long, Mark C.

2013-01-01

This article uses Florida administrative data to evaluate the role that public high schools play in the growing female advantage in college enrollment. We first show evidence of gender sorting across public high schools that is beyond what one would observe if students were randomly assigned to their schools. Using regression and decomposition…

Modifying Pro-Drug Risk Factors in Adolescents: Results from Project ALERT

ERIC Educational Resources Information Center

Ghosh-Dastidar, Bonnie; Longshore, Douglas L.; Ellickson, Phyllis L.; McCaffrey, Daniel F.

2004-01-01

The objective of this study was to evaluate the impact of a revised state-of-the-art drug prevention program, Project ALERT, on risk factors for drug use in mostly rural midwestern schools and communities. Fifty-five middle schools from South Dakota were randomly assigned to treatment or control conditions. Treatment-group students received 11…

Interventions to Reduce Distress in Adult Victims of Rape and Sexual Violence: A Systematic Review

ERIC Educational Resources Information Center

Regehr, Cheryl; Alaggia, Ramona; Dennis, Jane; Pitts, Annabel; Saini, Michael

2013-01-01

Objectives: This article presents a systematic evaluation of the effectiveness of interventions aimed at reducing distress in adult victims of rape and sexual violence. Method: Studies were eligible for the review if the assignment of study participants to experimental or control groups was by random allocation or parallel cohort design. Results:…

Design of the Resistance and Endurance exercise After ChemoTherapy (REACT) study: a randomized controlled trial to evaluate the effectiveness and cost-effectiveness of exercise interventions after chemotherapy on physical fitness and fatigue.

PubMed

Kampshoff, Caroline S; Buffart, Laurien M; Schep, Goof; van Mechelen, Willem; Brug, Johannes; Chinapaw, Mai J M

2010-11-30

Preliminary studies suggest that physical exercise interventions can improve physical fitness, fatigue and quality of life in cancer patients after completion of chemotherapy. Additional research is needed to rigorously test the effects of exercise programmes among cancer patients and to determine optimal training intensity accordingly. The present paper presents the design of a randomized controlled trial evaluating the effectiveness and cost-effectiveness of a high intensity exercise programme compared to a low-to-moderate intensity exercise programme and a waiting list control group on physical fitness and fatigue as primary outcomes. After baseline measurements, cancer patients who completed chemotherapy are randomly assigned to either a 12-week high intensity exercise programme or a low-to-moderate intensity exercise programme. Next, patients from both groups are randomly assigned to immediate training or a waiting list (i.e. waiting list control group). After 12 weeks, patients of the waiting list control group start with the exercise programme they have been allocated to.Both interventions consist of equal bouts of resistance and endurance interval exercises with the same frequency and duration, but differ in training intensity. Additionally, patients of both exercise programmes are counselled to improve compliance and achieve and maintain an active lifestyle, tailored to their individual preferences and capabilities.Measurements will be performed at baseline (t = 0), 12 weeks after randomization (t = 1), and 64 weeks after randomization (t = 2). The primary outcome measures are cardiorespiratory fitness and muscle strength assessed by means of objective performance indicators, and self-reported fatigue. Secondary outcome measures include health-related quality of life, self-reported physical activity, daily functioning, body composition, mood and sleep disturbances, and return to work. In addition, compliance and satisfaction with the interventions will be evaluated. Potential moderation by pre- and post-illness lifestyle, health and exercise-related attitudes, beliefs and motivation will also be assessed. Finally, the cost-effectiveness of both exercise interventions will be evaluated. This randomized controlled trial will be a rigorous test of effects of exercise programmes for cancer patients after chemotherapy, aiming to contribute to evidence-based practice in cancer rehabilitation programmes. This study is registered at the Netherlands Trial Register (NTR2153).

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...

Surgery versus physical therapy for a meniscal tear and osteoarthritis.

PubMed

Katz, Jeffrey N; Brophy, Robert H; Chaisson, Christine E; de Chaves, Leigh; Cole, Brian J; Dahm, Diane L; Donnell-Fink, Laurel A; Guermazi, Ali; Haas, Amanda K; Jones, Morgan H; Levy, Bruce A; Mandl, Lisa A; Martin, Scott D; Marx, Robert G; Miniaci, Anthony; Matava, Matthew J; Palmisano, Joseph; Reinke, Emily K; Richardson, Brian E; Rome, Benjamin N; Safran-Norton, Clare E; Skoniecki, Debra J; Solomon, Daniel H; Smith, Matthew V; Spindler, Kurt P; Stuart, Michael J; Wright, John; Wright, Rick W; Losina, Elena

2013-05-02

Whether arthroscopic partial meniscectomy for symptomatic patients with a meniscal tear and knee osteoarthritis results in better functional outcomes than nonoperative therapy is uncertain. We conducted a multicenter, randomized, controlled trial involving symptomatic patients 45 years of age or older with a meniscal tear and evidence of mild-to-moderate osteoarthritis on imaging. We randomly assigned 351 patients to surgery and postoperative physical therapy or to a standardized physical-therapy regimen (with the option to cross over to surgery at the discretion of the patient and surgeon). The patients were evaluated at 6 and 12 months. The primary outcome was the difference between the groups with respect to the change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical-function score (ranging from 0 to 100, with higher scores indicating more severe symptoms) 6 months after randomization. In the intention-to-treat analysis, the mean improvement in the WOMAC score after 6 months was 20.9 points (95% confidence interval [CI], 17.9 to 23.9) in the surgical group and 18.5 (95% CI, 15.6 to 21.5) in the physical-therapy group (mean difference, 2.4 points; 95% CI, -1.8 to 6.5). At 6 months, 51 active participants in the study who were assigned to physical therapy alone (30%) had undergone surgery, and 9 patients assigned to surgery (6%) had not undergone surgery. The results at 12 months were similar to those at 6 months. The frequency of adverse events did not differ significantly between the groups. In the intention-to-treat analysis, we did not find significant differences between the study groups in functional improvement 6 months after randomization; however, 30% of the patients who were assigned to physical therapy alone underwent surgery within 6 months. (Funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases; METEOR ClinicalTrials.gov number, NCT00597012.).

LEGO[R] Therapy and the Social Use of Language Programme: An Evaluation of Two Social Skills Interventions for Children with High Functioning Autism and Asperger Syndrome

ERIC Educational Resources Information Center

Owens, Gina; Granader, Yael; Humphrey, Ayla; Baron-Cohen, Simon

2008-01-01

LEGO[R] therapy and the Social Use of Language Programme (SULP) were evaluated as social skills interventions for 6-11 year olds with high functioning autism and Asperger Syndrome. Children were matched on CA, IQ, and autistic symptoms before being randomly assigned to LEGO or SULP. Therapy occurred for 1 h/week over 18 weeks. A no-intervention…

The effects of a daily facial lotion containing vitamins B3 and E and provitamin B5 on the facial skin of Indian women: a randomized, double-blind trial.

PubMed

Jerajani, Hemangi R; Mizoguchi, Haruko; Li, James; Whittenbarger, Debora J; Marmor, Michael J

2010-01-01

The B vitamins niacinamide and panthenol have been shown to reduce many signs of skin aging, including hyperpigmentation and redness. To measure the facial skin effects in Indian women of the daily use of a lotion containing niacinamide, panthenol, and tocopherol acetate using quantitative image analysis. Adult women 30-60 years of age with epidermal hyperpigmentation were recruited in Mumbai and randomly assigned to apply a test or control lotion to the face daily for 10 weeks. Effects on skin tone were measured using an image capturing system and associated software. Skin texture was assessed by expert graders. Barrier function was evaluated by transepithelial water loss measurements. Subjects and evaluators were blinded to the product assignment. Of 246 women randomized to treatment, 207 (84%) completed the study. Women who used the test lotion experienced significantly reduced appearance of hyperpigmentation, improved skin tone evenness, appearance of lightening of skin, and positive effects on skin texture. Improvements versus control were seen as early as 6 weeks. The test lotion was well tolerated. The most common adverse event was a transient, mild burning sensation. Daily use of a facial lotion containing niacinamide, panthenol, and tocopheryl acetate improved skin tone and texture and was well tolerated in Indian women with facial signs of aging.

Alternatives to the Randomized Controlled Trial

PubMed Central

West, Stephen G.; Duan, Naihua; Pequegnat, Willo; Gaist, Paul; Des Jarlais, Don C.; Holtgrave, David; Szapocznik, José; Fishbein, Martin; Rapkin, Bruce; Clatts, Michael; Mullen, Patricia Dolan

2008-01-01

Public health researchers are addressing new research questions (e.g., effects of environmental tobacco smoke, Hurricane Katrina) for which the randomized controlled trial (RCT) may not be a feasible option. Drawing on the potential outcomes framework (Rubin Causal Model) and Campbellian perspectives, we consider alternative research designs that permit relatively strong causal inferences. In randomized encouragement designs, participants are randomly invited to participate in one of the treatment conditions, but are allowed to decide whether to receive treatment. In quantitative assignment designs, treatment is assigned on the basis of a quantitative measure (e.g., need, merit, risk). In observational studies, treatment assignment is unknown and presumed to be nonrandom. Major threats to the validity of each design and statistical strategies for mitigating those threats are presented. PMID:18556609

Positron Emission Tomography-Guided Therapy of Aggressive Non-Hodgkin Lymphomas (PETAL): A Multicenter, Randomized Phase III Trial.

PubMed

Dührsen, Ulrich; Müller, Stefan; Hertenstein, Bernd; Thomssen, Henrike; Kotzerke, Jörg; Mesters, Rolf; Berdel, Wolfgang E; Franzius, Christiane; Kroschinsky, Frank; Weckesser, Matthias; Kofahl-Krause, Dorothea; Bengel, Frank M; Dürig, Jan; Matschke, Johannes; Schmitz, Christine; Pöppel, Thorsten; Ose, Claudia; Brinkmann, Marcus; La Rosée, Paul; Freesmeyer, Martin; Hertel, Andreas; Höffkes, Heinz-Gert; Behringer, Dirk; Prange-Krex, Gabriele; Wilop, Stefan; Krohn, Thomas; Holzinger, Jens; Griesshammer, Martin; Giagounidis, Aristoteles; Raghavachar, Aruna; Maschmeyer, Georg; Brink, Ingo; Bernhard, Helga; Haberkorn, Uwe; Gaska, Tobias; Kurch, Lars; van Assema, Daniëlle M E; Klapper, Wolfram; Hoelzer, Dieter; Geworski, Lilli; Jöckel, Karl-Heinz; Scherag, André; Bockisch, Andreas; Rekowski, Jan; Hüttmann, Andreas

2018-05-11

Purpose Interim positron emission tomography (PET) using the tracer, [ 18 F]fluorodeoxyglucose, may predict outcomes in patients with aggressive non-Hodgkin lymphomas. We assessed whether PET can guide therapy in patients who are treated with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). Patients and Methods Newly diagnosed patients received two cycles of CHOP-plus rituximab (R-CHOP) in CD20-positive lymphomas-followed by a PET scan that was evaluated using the ΔSUV max method. PET-positive patients were randomly assigned to receive six additional cycles of R-CHOP or six blocks of an intensive Burkitt's lymphoma protocol. PET-negative patients with CD20-positive lymphomas were randomly assigned or allocated to receive four additional cycles of R-CHOP or the same treatment with two additional doses rituximab. The primary end point was event-free survival time as assessed by log-rank test. Results Interim PET was positive in 108 (12.5%) and negative in 754 (87.5%) of 862 patients treated, with statistically significant differences in event-free survival and overall survival. Among PET-positive patients, 52 were randomly assigned to R-CHOP and 56 to the Burkitt protocol, with 2-year event-free survival rates of 42.0% (95% CI, 28.2% to 55.2%) and 31.6% (95% CI, 19.3% to 44.6%), respectively (hazard ratio, 1.501 [95% CI, 0.896 to 2.514]; P = .1229). The Burkitt protocol produced significantly more toxicity. Of 754 PET-negative patients, 255 underwent random assignment (129 to R-CHOP and 126 to R-CHOP with additional rituximab). Event-free survival rates were 76.4% (95% CI, 68.0% to 82.8%) and 73.5% (95% CI, 64.8% to 80.4%), respectively (hazard ratio, 1.048 [95% CI, 0.684 to 1.606]; P = .8305). Outcome prediction by PET was independent of the International Prognostic Index. Results in diffuse large B-cell lymphoma were similar to those in the total group. Conclusion Interim PET predicted survival in patients with aggressive lymphomas treated with R-CHOP. PET-based treatment intensification did not improve outcome.

Effectiveness of Placebo Therapy for Maintaining Masking in a Clinical Trial of Vergence/Accommodative Therapy

PubMed Central

Kulp, Marjean; Mitchell, G. Lynn; Borsting, Eric; Scheiman, Mitchell; Cotter, Susan; Rouse, Michael; Tamkins, Susanna; Mohney, Brian G.; Toole, Andrew; Reuter, Kathleen

2009-01-01

Purpose To evaluate the effectiveness of the Convergence Insufficiency Treatment Trial (CITT) placebo therapy program in maintaining masking of patients randomized to the office-based treatment arms, determine whether demographic variables affect masking, and determine whether perception of assigned treatment group was associated with treatment outcome or adherence to treatment. Methods Patients (n = 221, ages, 9–17 years) were randomized to one of four treatment groups, two of which were office-based and masked to treatment (n = 114). The placebo therapy program was designed to appear to be real vergence/accommodative therapy, without stimulating vergence, accommodation, or fine saccades (beyond levels of daily visual activities). After treatment, patients in the office-based groups were asked whether they thought they had received real or placebo therapy and how confident they were in their answers. Results Ninety-three percent of patients assigned to real therapy and 85% assigned to placebo therapy thought they were in the real therapy group (P = 0.17). No significant differences were found between the two groups in adherence to the therapy (P ≥ 0.22 for all comparisons). The percentage of patients who thought they were assigned to real therapy did not differ by age, sex, race, or ethnicity (P > 0.30 for all comparisons). No association was found between patients' perception of group assignment and symptoms or signs at outcome (P ≥ 0.38 for all comparisons). Conclusions The CITT placebo therapy program was effective in maintaining patient masking in this study and therefore may have potential for use in future clinical trials using vergence/accommodative therapy. Masking was not affected by demographic variables. Perception of group assignment was not related to symptoms or signs at outcome (ClinicalTrials.gov number, NCT00338611). PMID:19151384

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.

Evaluation of a Drowning Prevention Program Based on Testimonial Videos: A Randomized Controlled Trial

PubMed Central

Pang, Shulan; Schwebel, David C.

2016-01-01

Objective Unintentional drowning is the most common cause of childhood death in rural China. Global intervention efforts offer mixed results regarding the efficacy of educational programs. Methods Using a randomized controlled design, we evaluated a testimonial-based intervention to reduce drowning risk among 280 3rd- and 4th-grade rural Chinese children. Children were randomly assigned to view either testimonials on drowning risk (intervention) or dog-bite risk (control). Safety knowledge and perceived vulnerability were measured by self-report questionnaires, and simulated behaviors in and near water were assessed with a culturally appropriate dollhouse task. Results Children in the intervention group had improved children’s safety knowledge and simulated behaviors but not perceived vulnerability compared with controls. Conclusions The testimonial-based intervention’s efficacy appears promising, as it improved safety knowledge and simulated risk behaviors with water among rural Chinese children. PMID:26546476

Use of video eyeglasses to decrease anxiety among children undergoing genital examinations.

PubMed

Berenson, A B; Wiemann, C M; Rickert, V I

1998-06-01

Our purpose was to compare three techniques in their ability to decrease anxiety induced by the pelvic examination among children of different races. Eighty-nine subjects between 3 and 8 years old of white, African-American, and Hispanic race or ethnicity were randomly assigned to one of three distraction techniques that was used during the genital examination: passive play (being read to), active play (singing, blowing bubbles), or viewing a movie through video eyeglasses. Levels of vocalized distress, as well as distress expressed by physical behavior and emotional support requested, were directly observed and recorded. Children also reported their level of satisfaction at the end of the examination. Multivariate analysis of covariance was used to evaluate the independent effects of each technique and race while we controlled for confounding variables. Levels of physical distress were lowest among children who used video glasses and highest among those randomly assigned to passive play (p = 0.02). Children randomized to video glasses also expressed higher levels of satisfaction than those randomized to active (p = 0.001) or passive (p = 0.05) play. No differences associated with race or ethnicity were detected. This study demonstrates that video glasses are more effective than active or passive play in reducing anxiety and improving satisfaction levels among children undergoing a genital examination.

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.

Clinical evaluation of a novel herbal dental cream in plaque formation: a double-blind, randomized, controlled clinical trial

PubMed Central

Amrutesh, Sunita; Malini, J; Tandur, Prakash S; Patki, Pralhad S

2010-01-01

Background The aim of this study was to evaluate the efficacy and safety of herbal dental cream in comparison to fluoride dental cream. Objectives Clinical evaluation of a novel herbal dental cream in plaque formation: a double-blind, randomized, controlled clinical trial. Methods One hundred and two patients with established dental plaque were randomly assigned to either herbal dental group or fluoride dental group for six weeks in a double-blind design. Improvement in plaque index, oral hygiene status, bleeding index, and gingival index was evaluated in these patients along with microbiological study. Results Results indicated a significant reduction in plaque index, gingival index, oral hygiene index, and microbial growth in both groups. Difference between the groups was not significant. There was no significant change in bleeding index. No adverse events were reported and both the dental creams were well tolerated. Conclusion The finding of this preliminary study indicates that herbal dental cream is as safe and effective as fluoride dental cream, but not superior to it. PMID:27186096

Safety and Efficacy of Rice Bran Supercritical CO2 Extract for Hair Growth in Androgenic Alopecia: A 16-Week Double-Blind Randomized Controlled Trial.

PubMed

Choi, Jae-Suk; Park, Jae Beom; Moon, Woi-Sook; Moon, Jin-Nam; Son, Sang Wook; Kim, Mi-Ryung

2015-01-01

We conducted a 16-week double-blind randomized controlled single-center trial to evaluate the safety and efficacy of dermal rice bran supercritical CO2 extract (RB-SCE) in the treatment of androgenic alopecia. Fifty alopecia patients were randomly assigned to the experimental and placebo groups. The experimental group received a dermal application of 0.5% RB-SCE (8 mL/d) to the head skin for 16 weeks while the control group received a dermal application of placebo. Changes in hair count, diameter, and density were evaluated with a Folliscope(®). Patient satisfaction was evaluated via questionnaire and clinical photographs were rated by dermatologists. The results showed that RB-SCE significantly increased hair density and hair diameter in male subjects. Patient satisfaction and the evaluation of photographs by dermatologists also confirmed the effectiveness of RB-SCE in the treatment of alopecia. No adverse reactions related to RB-SCE were reported. Therefore, RB-SCE shows promise for use in functional cosmetics and pharmaceuticals.

Impact of Chess Training on Mathematics Performance and Concentration Ability of Children with Learning Disabilities

ERIC Educational Resources Information Center

Scholz, Markus; Niesch, Harald; Steffen, Olaf; Ernst, Baerbel; Loeffler, Markus; Witruk, Evelin; Schwarz, Hans

2008-01-01

The aim of this study is to evaluate the benefit of chess in mathematics lessons for children with learning disabilities based on lower intelligence (IQ 70-85). School classes of four German schools for children with learning disabilities were randomly assigned to receive one hour of chess lesson instead of one hour of regular mathematics lessons…

Short communication: effect of oilseed supplementation of an herbage diet on ruminal fermentation in continuous culture

USDA-ARS?s Scientific Manuscript database

A four-unit continuous culture fermentor system was used to evaluate the effects of oilseed supplementation of an herbage-based diet on ruminal fermentation. Treatments were randomly assigned to fermentors in a 4 x 4 Latin square design with 7 d for diet adaptation and 3 d for data and sample collec...

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…

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...

Encouraging Evidence on a Sector-Focused Advancement Strategy: Two-Year Impacts from the WorkAdvance Demonstration

ERIC Educational Resources Information Center

Hendra, Richard; Greenberg, David H.; Hamilton, Gayle; Oppenheim, Ari; Pennington, Alexandra; Schaberg, Kelsey; Tessler, Betsy L.

2016-01-01

This report summarizes the two-year findings of a rigorous random assignment evaluation of the WorkAdvance model, a sectoral training, and advancement initiative. Launched in 2011, WorkAdvance goes beyond the previous generation of employment programs by introducing demand-driven skills training and a focus on jobs that have career pathways. The…

Thermal equilibrium of Nellore cattle in tropical conditions: an investigation of circadian pattern

USDA-ARS?s Scientific Manuscript database

The aim of this work was to evaluate the diurnal patterns of physiological responses and the thermal regulation of adult Nellore bulls. Six 30-mo-old Nellore bulls (669 ± 65 kg BW) were randomly assigned to four 6-h periods in a Latin Square design such that measurements of each animal cover a 24-h ...

The Role of Gender in Youth Mentoring Relationship Formation and Duration

ERIC Educational Resources Information Center

Rhodes, Jean; Lowe, Sarah R.; Litchfield, Leon; Walsh-Samp, Kathy

2008-01-01

The role of gender in shaping the course and quality of adult-youth mentoring relationships was examined. The study drew on data from a large, random assignment evaluation of Big Brothers Big Sisters of America (BBSA) programs [Grossman, J. B., & Tierney, J. P. (1998). Does mentoring work? An impact study of the Big Brothers Big Sisters program.…

Effect of Low-Carbohydrate Claims on Consumer Perceptions about Food Products' Healthfulness and Helpfulness for Weight Management

ERIC Educational Resources Information Center

Labiner-Wolfe, Judith; Lin, Chung-Tung Jordan; Verrill, Linda

2010-01-01

Objective: Evaluate effect of low-carbohydrate claims on consumer perceptions about food products' healthfulness and helpfulness for weight management. Design: Experiment in which participants were randomly assigned 1 of 12 front-of-package claim conditions on bread or a frozen dinner. Seven of the 12 conditions also included Nutrition Facts (NF)…

An Experimental Evaluation of a School-Based Emancipatory Intervention to Promote African American Well-Being and Youth Leadership

ERIC Educational Resources Information Center

Lewis, Kelly M.; Sullivan, Cris M.; Bybee, Deborah

2006-01-01

This study experimentally examined the effect of a school-based emancipatory intervention on the psychological and behavioral well-being of African American adolescents. Sixty-five eighth graders in an inner-city, predominantly Black school were randomly assigned to either receive the experimental intervention or a regular Life Skills course (the…

Effect of dietary Allium hookeri on growth performance and anti-oxidant activity in young broiler chicken

USDA-ARS?s Scientific Manuscript database

The aim of this study was to evaluate the effect of dietary supplementation of Allium hookeri root on anti-oxidant activity and growth performance in young broiler chickens. A total of 125 male Ross-708 broiler chickens were randomly assigned to 5 groups (n=25 birds/group) and fed with standard die...

Yeast supplementation reduced the immune and metabolic responses to a combined viral-bacterial respiratory disease challenge in feedlot heifers

USDA-ARS?s Scientific Manuscript database

Two treatments were evaluated in commercial feedlot heifers to determine the effects of a yeast supplement on immune and metabolic responses to a combined viral-bacterial respiratory disease challenge. Thirty-two beef heifers (324 ± 19.2 kg BW) were selected and randomly assigned to one of two treat...

The Anger Management Project: A Group Intervention for Anger in People with Physical and Multiple Disabilities

ERIC Educational Resources Information Center

Hagiliassis, Nick; Gulbenkoglu, Hrepsime; Di Marco, Mark; Young, Suzanne; Hudson, Alan

2005-01-01

Background: This paper describes the evaluation of a group program designed specifically to meet the anger management needs of a group of individuals with various levels of intellectual disability and/or complex communication needs. Method: Twenty-nine individuals were randomly assigned to an intervention group or a waiting-list comparison group.…

Differential Therapeutic Outcomes of Community-Based Group Interventions for Women and Children Exposed to Intimate Partner Violence

ERIC Educational Resources Information Center

McWhirter, Paula T.

2011-01-01

Two community-based group therapies, emotion focused versus goal oriented, are compared among women exposed to intimate partner violence (n = 46) and their children (n = 48) aged between 6 and 12 years. A series of repeated measures analyses are employed to evaluate the effects of time from baseline to postintervention following random assignment.…

Preventing Behavior Problems among Elementary Schoolchildren: Impact of a Universal School-Based Program in China

ERIC Educational Resources Information Center

Hong, Lin; Yufeng, Wang; Agho, Kingsley; Jacobs, Jennifer

2011-01-01

Background: To evaluate the effect on problem behaviors of a universal school-based prevention curriculum of third grade students. Methods: Six regular classes in 1 elementary school were randomly assigned to an intervention (n = 208) or control (n = 209) group. A 13-session program was offered to students in the intervention group. The Achenbach…

An Evaluation of Cognitive Processing Therapy for the Treatment of Posttraumatic Stress Disorder Related to Childhood Sexual Abuse

ERIC Educational Resources Information Center

Chard, Kathleen M.

2005-01-01

This study compared the effectiveness of cognitive processing therapy for sexual abuse survivors (CPT-SA) with that of the minimal attention (MA) given to a wait-listed control group. Seventy-one women were randomly assigned to 1 of the 2 groups. Participants were assessed at pretreatment and 3 times during posttreatment: immediately after…

Multiple-Component Remediation for Developmental Reading Disabilities: IQ, Socioeconomic Status, and Race as Factors in Remedial Outcome

ERIC Educational Resources Information Center

Morris, Robin D.; Lovett, Maureen W.; Wolf, Maryanne; Sevcik, Rose A.; Steinbach, Karen A.; Frijters, Jan C.; Shapiro, Marla B.

2012-01-01

Results from a controlled evaluation of remedial reading interventions are reported: 279 young disabled readers were randomly assigned to a program according to a 2 x 2 x 2 factorial design (IQ, socioeconomic status [SES], and race). The effectiveness of two multiple-component intervention programs for children with reading disabilities (PHAB +…

Effects of Monetary Incentives on Engagement in the PACE Parenting Program

ERIC Educational Resources Information Center

Dumas, Jean E.; Begle, Angela Moreland; French, Brian; Pearl, Amanda

2010-01-01

This study evaluated parental engagement in an 8-week parenting program offered through daycare centers that were randomly assigned to a monetary incentive or nonincentive condition. Of an initial sample of 1,050 parents who rated their intent to enroll in the program, 610 went on to enroll--319 in the incentive and 291 in the nonincentive…

Enhancing a Classroom Social Competence and Problem-Solving Curriculum by Offering Parent Training to Families of Moderate- to High-Risk Elementary School Children

ERIC Educational Resources Information Center

Reid, M. Jamila; Webster-Stratton, Carolyn; Hammond, Mary

2007-01-01

The Incredible Years parent and classroom interventions were evaluated for the first time in elementary schools. Culturally diverse, socioeconomically disadvantaged schools were randomly assigned to intervention or control (CON). In intervention schools, all children received a 2-year classroom intervention beginning in kindergarten. In addition,…

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 effects of a modified glucomannan on the performance of stocker cattle grazing endophyte infected tall fescue

USDA-ARS?s Scientific Manuscript database

To evaluate the efficacy of a modified glucomannan to mitigate fescue toxicosis, 45 Angus cross (BW = 281 ± 7.0 kg) steer calves were randomly assigned to nine 2-ha pastures of endemically-infected tall fescue in March of 2 yr and allowed to graze for 133 d. The 3 treatments were: non supplemented (...

Comparing the Effectiveness of On-Line versus In-Person Caregiver Education and Training for Behavioral Regulation in Families of Children with FASD

ERIC Educational Resources Information Center

Kable, Julie A.; Coles, Claire D.; Strickland, Dorothy; Taddeo, Elles

2012-01-01

Different formats for delivering parent education designed to improve the functioning of children with FASD were evaluated. Participants were randomly assigned to a treatment condition: (1) Community Standard/Informational Packet, (2) Group Workshops, and (3) Internet Training. Overall satisfaction was high for all formats but the Workshop group…

Encouraging Evidence on a Sector-Focused Advancement Strategy: Two-Year Impacts from the WorkAdvance Demonstration. Preview Summary

ERIC Educational Resources Information Center

Hendra, Richard; Greenberg, David H.; Hamilton, Gayle; Oppenheim, Ari; Pennington, Alexandra; Schaberg, Kelsey; Tessler, Betsy L.

2016-01-01

This report summarizes the two-year findings of a rigorous random assignment evaluation of the WorkAdvance model, a sectoral training and advancement initiative. Launched in 2011, WorkAdvance goes beyond the previous generation of employment programs by introducing demand-driven skills training and a focus on jobs that have career pathways. The…

Influence of two different doses of infectious bovine rhinotracheitis virus (IBRV) on immune and physiological parameters in steers

USDA-ARS?s Scientific Manuscript database

To evaluate the effects different doses of IBRV and the impact they have on immunological and physiological parameters of cattle, 18 Holstein steers (450.11 ± 75.70 kg) were randomly assigned to either a control group or 1 of 2 IBRV challenged groups. Prior to the challenge, steers were fitted with ...

A Comparison Study of the Effectiveness of the Lexia Reading Programme

ERIC Educational Resources Information Center

Ness, Mike; Couperus, Josh; Willey, Matthew

2013-01-01

This study evaluates the efficacy of the Lexia Reading (LR) programme with a cohort of 37 students in a Decile 1 primary school. The students were randomly assigned to experimental (who used LR) and control groups (who did not use LR). The WIAT-II was used to provide pre and post measures of literacy skills. Results indicated that students who…

Learning through Interaction in Children with Autism: Preliminary Data from a Social-Communication-Based Intervention

ERIC Educational Resources Information Center

Casenhiser, Devin M.; Shanker, Stuart G.; Stieben, Jim

2013-01-01

The study evaluates a social-communication-based approach to autism intervention aimed at improving the social interaction skills of children with autism spectrum disorder. We report preliminary results from an ongoing randomized controlled trial of 51 children aged 2 years 0 months to 4 years 11 months. Participants were assigned to either a…

Effects of Automobile Commute Characteristics on Affect and Job Candidate Evaluations: A Field Experiment

ERIC Educational Resources Information Center

Van Rooy, David L.

2006-01-01

The current study assesses the effects of the commuting environment on affective states and hiring decisions. A total of 136 undergraduate females were randomly assigned to one of four conditions based on the length (10 km vs. 30 km) and level of congestion (low vs. high) during a commute. Multivariate analyses of variance indicate that affective…

What Works Clearinghouse Quick Review of the Report "Evaluation of Experience Corps: Student Reading Outcomes"

ERIC Educational Resources Information Center

What Works Clearinghouse, 2010

2010-01-01

This study examined whether the "Experience Corps" program improved the reading skills of elementary school students who were at risk of academic failure. Nearly 900 first through third grade students in 23 schools in Boston, New York City, and Port Arthur, TX participated in the study. These students were randomly assigned to either a…

How Does Your Kindergarten Classroom Affect Your Earnings? Evidence from Project STAR. NBER Working Paper No. 16381

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 within their schools from kindergarten to third grade. This paper evaluates the long-term impacts of STAR using administrative records. We obtain five results. First, kindergarten test scores are highly correlated with outcomes such as…

Examining the Efficacy of a Multitiered Intervention for At-Risk Readers in Grade 1

ERIC Educational Resources Information Center

Smith, Jean Louise M.; Nelson, Nancy J.; Fien, Hank; Smolkowski, Keith; Kosty, Derek; Baker, Scott K.

2016-01-01

This study reports the results of a cluster RCT evaluating the impact of Enhanced Core Reading Instruction on reading achievement of grade 1 at-risk readers. Forty-four elementary schools, blocked by district, were randomly assigned to condition. In both conditions, at-risk readers received 90 minutes of whole-group instruction (Tier 1) plus an…

Two Years of Case Management: Final Findings from the Communities in Schools Random Assignment Evaluation

ERIC Educational Resources Information Center

Parise, Leigh M.; Corrin, William; Granito, Kelly; Haider, Zeest; Somers, Marie-Andrée; Cerna, Oscar

2017-01-01

While high school graduation rates are on the rise nationwide, too many students still never reach that milestone, with 7,000 on average dropping out every day. Recognizing that many students need additional support to succeed in school, Communities In Schools (CIS) works to provide and connect students with integrated support services to keep…

Career Academies: A Proven Strategy to Prepare High School Students for College and Careers

ERIC Educational Resources Information Center

Stern, David; Dayton, Charles; Raby, Marilyn

2010-01-01

Career academies, after more than four decades of development and three decades of evaluation, have been found by a conclusive random assignment study to be effective in improving outcomes for students during and after high school. Career academies have therefore become the most durable and best-tested component of a high school reform strategy to…

Influence of thermally peroxidized soybean oil on growth performance and oxidative status in growing pigs

USDA-ARS?s Scientific Manuscript database

The objective of this study was to evaluate the effect of feeding peroxidized soybean oil (SO) on growth performance and oxidative status in growing pigs. Fifty-six barrows (25.3 ± 3.3 kg initial BW) were randomly assigned to one of four diets containing either 10% fresh SO (22.5 C) or SO exposed to...

Psychosocial Outcomes of "Lunch Is in the Bag", a Parent Program for Packing Healthful Lunches for Preschool Children

ERIC Educational Resources Information Center

Sweitzer, Sara J.; Briley, Margaret E.; Roberts-Gray, Cindy; Hoelscher, Deanna M.; Harrist, Ronald B.; Staskel, Deanna M.; Almansour, Fawaz D.

2011-01-01

Objective: This pilot study evaluated effects of "Lunch is in the Bag" on behavioral constructs and their predictive relationship to lunch-packing behaviors of parents of young children. Methods: Six child care centers were pair-matched and randomly assigned to intervention (n = 3) and comparison (n = 3) groups. Parent/child dyads participated.…

Evaluation of the Teacher Incentive Fund: Implementation and Early Impacts of Pay-for-Performance after One Year. NCEE 2014-4019

ERIC Educational Resources Information Center

Max, Jeffrey; Constantine, Jill; Wellington, Alison; Hallgren, Kristin; Glazerman, Steven; Chiang, Hanley; Speroni, Cecilia

2014-01-01

The Teacher Incentive Fund (TIF) provides grants to support performance-based compensation systems for teachers and principals in high-need schools. The study measures the impact of pay-for-performance bonuses as part of a comprehensive compensation system within a large, multisite random assignment study design. The treatment schools were to…

Measuring Student Growth within a Merit-Pay Evaluation System: Perceived Effects on Music Teacher Motivation Career Commitment

ERIC Educational Resources Information Center

Munroe, Angela

2017-01-01

In this experimental study, music teachers from a large school district were randomly assigned to one of two hypothetical conditions reflecting different methods for measuring student growth under a merit pay compensation system. In Scenario A, half of a teacher's effectiveness rating was based on student standardized test scores in reading,…

Evaluation of the Teacher Incentive Fund: Implementation and Impacts of Pay-for-Performance after Two Years. NCEE 2015-4020

ERIC Educational Resources Information Center

Chiang, Hanley; Wellington, Alison; Hallgren, Kristin; Speroni, Cecilia; Herrmann, Mariesa; Glazerman, Steven; Constantine, Jill

2015-01-01

The Teacher Incentive Fund (TIF) provides grants to support performance-based compensation systems for teachers and principals in high-need schools. The study measures the impact of pay-for-performance bonuses as part of a comprehensive compensation system within a large, multisite random assignment study design. The treatment schools were to…

Evaluation of Agrilus planipennis (Coleoptera: Buprestidae) control provided by emamectin benzoate and two neonicotinoid insecticides, one and two seasons after treatment

Treesearch

Deborah G. McCullough; Therese M. Poland; Andrea C. Anulewicz; Phillip Lewis; David. Cappaert

2011-01-01

Effective methods are needed to protect ash trees (Fraxinus spp.) from emerald ash borer, Agrilus planipennis Fairmaire (Coleoptera: Buprestidae), an invasive buprestid that has killed millions of North American ash (Fraxinus spp.) trees. We randomly assigned 175 ash trees (11.5-48.1 cm in diameter) in 25 blocks...

Comparison between two surgical techniques for root coverage with an acellular dermal matrix graft.

PubMed

Andrade, Patrícia F; Felipe, Maria Emília M C; Novaes, Arthur B; Souza, Sérgio L S; Taba, Mário; Palioto, Daniela B; Grisi, Márcio F M

2008-03-01

The aim of this randomized, controlled, clinical study was to compare two surgical techniques with the acellular dermal matrix graft (ADMG) to evaluate which technique could provide better root coverage. Fifteen patients with bilateral Miller Class I gingival recession areas were selected. In each patient, one recession area was randomly assigned to the control group, while the contra-lateral recession area was assigned to the test group. The ADMG was used in both groups. The control group was treated with a broader flap and vertical-releasing incisions, and the test group was treated with the proposed surgical technique, without releasing incisions. The clinical parameters evaluated before the surgeries and after 12 months were: gingival recession height, probing depth, relative clinical attachment level and the width and thickness of keratinized tissue. There were no statistically significant differences between the groups for all parameters at baseline. After 12 months, there was a statistically significant reduction in recession height in both groups, and there was no statistically significant difference between the techniques with regard to root coverage. Both surgical techniques provided significant reduction in gingival recession height after 12 months, and similar results in relation to root coverage.

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).

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...

Teacher-Child Interaction Training: A Pilot Study With Random Assignment.

PubMed

Fernandez, Melanie A; Adelstein, Jonathan S; Miller, Samantha P; Areizaga, Margaret J; Gold, Dylann C; Sanchez, Amanda L; Rothschild, Sara A; Hirsch, Emily; Gudiño, Omar G

2015-07-01

Teacher-Child Interaction Training (TCIT), adapted from Parent-Child Interaction Therapy (PCIT), is a classroom-based program designed to provide teachers with behavior management skills that foster positive teacher-student relationships and to improve student behavior by creating a more constructive classroom environment. The purpose of this pilot study was to evaluate TCIT in more classrooms than previously reported in the literature, with older children than previously reported, using random assignment of classrooms to TCIT or to a no-TCIT control condition and conducting all but two sessions within the classroom to enhance feasibility. Participants included 11 kindergarten and first grade classroom teachers and their 118 students from three urban, public schools in Manhattan, with five classrooms randomly assigned to receive TCIT and six to the no-TCIT control condition. Observations of teacher skill acquisition were conducted before, during, and after TCIT for all 11 teachers, and teacher reports of student behavior were obtained at these same time points. Teacher satisfaction with TCIT was assessed following training. Results suggested that after receiving TCIT, teachers increased rates of positive attention to students' appropriate behavior, decreased rates of negative attention to misbehavior, reported significantly less distress related to student disruptive behavior, and reported high satisfaction with the training program. Our study supports the growing evidence-base suggesting that TCIT is a promising approach for training teachers in positive behavior management strategies and for improving student disruptive behavior in the classroom. Copyright © 2015. Published by Elsevier Ltd.

Evaluation of life and death studies course on attitudes toward life and death among nursing students.

PubMed

Hwang, Huei-Lih; Lin, Huey-Shyan; Chen, Wen-Tin

2005-12-01

The aim of this study was to evaluate attitudes toward life and death among nursing students after attending the life and death studies (LDS) program. Both qualitative and quantitative methods were used to collect data. The pretest-posttest control group design randomly assigned students to an experimental (n = 47) or control group (n = 49). The 13-week course included lectures, video appraisal, games, simulations, films, books, assignments and group sharing. Statistical and content analysis were used to analyze qualitative and quantitative data. The findings showed a significant improvement in perception of the meaningfulness of life in four categories of improvement: expanded viewpoint, sadness about death, treating life sincerely, and instilling hope in life. The qualitative data indicated that a positive change in meaning of life was associated with interaction with others and self-reflection.

Randomized Trial Using Gonadotropin-Releasing Hormone Agonist Triptorelin for the Preservation of Ovarian Function During (Neo)Adjuvant Chemotherapy for Breast Cancer

PubMed Central

Munster, Pamela N.; Moore, Amy P.; Ismail-Khan, Roohi; Cox, Charles E.; Lacevic, Mensura; Gross-King, Margaret; Xu, Ping; Carter, W. Bradford; Minton, Susan E.

2012-01-01

Purpose Chemotherapy-induced amenorrhea is a serious concern for women undergoing cancer therapy. This prospective randomized trial evaluated the use of gonadotropin-releasing hormone (GnRH) analog triptorelin to preserve ovarian function in women treated with chemotherapy for early-stage breast cancer. Patients and Methods Premenopausal women age 44 years or younger were randomly assigned to receive either triptorelin or no triptorelin during (neo)adjuvant chemotherapy and were further stratified by age (< 35, 35 to 39, > 39 years), estrogen receptor status, and chemotherapy regimen. Objectives included the resumption of menses and serial monitoring of follicle-stimulating hormone (FSH) and inhibin A and B levels. Results Targeted for 124 patients with a planned 5-year follow-up, the trial was stopped for futility after 49 patients were enrolled (median age, 39 years; range, 21 to 43 years); 47 patients were treated according to assigned groups with four cycles of adriamycin plus cyclophosphamide alone or followed by four cycles of paclitaxel or six cycles of fluorouracil, epirubicin, and cyclophosphamide. Menstruation resumed in 19 (90%) of 21 patients in the control group and in 23 (88%) of 26 in the triptorelin group (P= .36). Menses returned after a median of 5.8 months (range, 1 to 19 months) after completion of chemotherapy in the triptorelin versus 5.0 months (range, 0 to 28 months) in the control arm (P= .58). Two patients (age 26 and 35 years at random assignment) in the control group had spontaneous pregnancies with term deliveries. FSH and inhibin B levels correlated with menstrual status. Conclusion When stratified for age, estrogen receptor status, and treatment regimen, amenorrhea rates on triptorelin were comparable to those seen in the control group. PMID:22231041

Randomized trial using gonadotropin-releasing hormone agonist triptorelin for the preservation of ovarian function during (neo)adjuvant chemotherapy for breast cancer.

PubMed

Munster, Pamela N; Moore, Amy P; Ismail-Khan, Roohi; Cox, Charles E; Lacevic, Mensura; Gross-King, Margaret; Xu, Ping; Carter, W Bradford; Minton, Susan E

2012-02-10

Chemotherapy-induced amenorrhea is a serious concern for women undergoing cancer therapy. This prospective randomized trial evaluated the use of gonadotropin-releasing hormone (GnRH) analog triptorelin to preserve ovarian function in women treated with chemotherapy for early-stage breast cancer. Premenopausal women age 44 years or younger were randomly assigned to receive either triptorelin or no triptorelin during (neo)adjuvant chemotherapy and were further stratified by age (< 35, 35 to 39, > 39 years), estrogen receptor status, and chemotherapy regimen. Objectives included the resumption of menses and serial monitoring of follicle-stimulating hormone (FSH) and inhibin A and B levels. Targeted for 124 patients with a planned 5-year follow-up, the trial was stopped for futility after 49 patients were enrolled (median age, 39 years; range, 21 to 43 years); 47 patients were treated according to assigned groups with four cycles of adriamycin plus cyclophosphamide alone or followed by four cycles of paclitaxel or six cycles of fluorouracil, epirubicin, and cyclophosphamide. Menstruation resumed in 19 (90%) of 21 patients in the control group and in 23 (88%) of 26 in the triptorelin group (P= .36). Menses returned after a median of 5.8 months (range, 1 to 19 months) after completion of chemotherapy in the triptorelin versus 5.0 months (range, 0 to 28 months) in the control arm (P= .58). Two patients (age 26 and 35 years at random assignment) in the control group had spontaneous pregnancies with term deliveries. FSH and inhibin B levels correlated with menstrual status. When stratified for age, estrogen receptor status, and treatment regimen, amenorrhea rates on triptorelin were comparable to those seen in the control group.

Phase III randomized clinical trial comparing tremelimumab with standard-of-care chemotherapy in patients with advanced melanoma.

PubMed

Ribas, Antoni; Kefford, Richard; Marshall, Margaret A; Punt, Cornelis J A; Haanen, John B; Marmol, Maribel; Garbe, Claus; Gogas, Helen; Schachter, Jacob; Linette, Gerald; Lorigan, Paul; Kendra, Kari L; Maio, Michele; Trefzer, Uwe; Smylie, Michael; McArthur, Grant A; Dreno, Brigitte; Nathan, Paul D; Mackiewicz, Jacek; Kirkwood, John M; Gomez-Navarro, Jesus; Huang, Bo; Pavlov, Dmitri; Hauschild, Axel

2013-02-10

In phase I/II trials, the cytotoxic T lymphocyte-associated antigen-4-blocking monoclonal antibody tremelimumab induced durable responses in a subset of patients with advanced melanoma. This phase III study evaluated overall survival (OS) and other safety and efficacy end points in patients with advanced melanoma treated with tremelimumab or standard-of-care chemotherapy. Patients with treatment-naive, unresectable stage IIIc or IV melanoma were randomly assigned at a ratio of one to one to tremelimumab (15 mg/kg once every 90 days) or physician's choice of standard-of-care chemotherapy (temozolomide or dacarbazine). In all, 655 patients were enrolled and randomly assigned. The test statistic crossed the prespecified futility boundary at second interim analysis after 340 deaths, but survival follow-up continued. At final analysis with 534 events, median OS by intent to treat was 12.6 months (95% CI, 10.8 to 14.3) for tremelimumab and 10.7 months (95% CI, 9.36 to 11.96) for chemotherapy (hazard ratio, 0.88; P = .127). Objective response rates were similar in the two arms: 10.7% in the tremelimumab arm and 9.8% in the chemotherapy arm. However, response duration (measured from date of random assignment) was significantly longer after tremelimumab (35.8 v 13.7 months; P = .0011). Diarrhea, pruritus, and rash were the most common treatment-related adverse events in the tremelimumab arm; 7.4% had endocrine toxicities. Seven deaths in the tremelimumab arm and one in the chemotherapy arm were considered treatment related by either investigators or sponsor. This study failed to demonstrate a statistically significant survival advantage of treatment with tremelimumab over standard-of-care chemotherapy in first-line treatment of patients with metastatic melanoma.

Outcomes by sex following treatment initiation with atazanavir plus ritonavir or efavirenz with abacavir/lamivudine or tenofovir/emtricitabine.

PubMed

Smith, Kimberly Y; Tierney, Camlin; Mollan, Katie; Venuto, Charles S; Budhathoki, Chakra; Ma, Qing; Morse, Gene D; Sax, Paul; Katzenstein, David; Godfrey, Catherine; Fischl, Margaret; Daar, Eric S; Collier, Ann C

2014-02-01

We aimed to evaluate treatment responses to atazanavir plus ritonavir (ATV/r) or efavirenz (EFV) in initial antiretroviral regimens among women and men, and determine if treatment outcomes differ by sex. We performed a randomized trial of open-label ATV/r or EFV combined with abacavir/lamivudine (ABC/3TC) or tenofovir/emtricitabine (TDF/FTC) in 1857 human immunodeficiency virus type 1-infected, treatment-naive persons enrolled between September 2005 and November 2007 at 59 sites in the United States and Puerto Rico. Associations of sex with 3 primary study endpoints of time to virologic failure, safety, and tolerability events were analyzed using Cox proportional hazards models. Model-based population pharmacokinetic analysis was performed using nonlinear mixed effects modeling (NONMEM version VII). Of 1857 participants, 322 were women. Women assigned to ATV/r had a higher risk of virologic failure with either nucleoside reverse transcriptase inhibitor backbone than women assigned to EFV, or men assigned to ATV/r. The effects of ATV/r and EFV upon safety and tolerability risk did not differ significantly by sex. With ABC/3TC, women had a significantly higher (32%) safety risk compared to men; with TDF/FTC, the safety risk was 20% larger for women compared to men, but not statistically significant. Women had slower ATV clearance and higher predose levels of ATV compared to men. Self-reported adherence did not differ significantly by sex. This is the first randomized clinical trial to identify a significantly earlier time to virologic failure in women randomized to ATV/r compared to women randomized to EFV. This finding has important clinical implications given that boosted protease inhibitors are often favored over EFV in women of childbearing potential. NCT00118898.

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…

Intraclass Correlation Values for Planning Group-Randomized Trials in Education

ERIC Educational Resources Information Center

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

2007-01-01

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

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…

Compliance-Effect Correlation Bias in Instrumental Variables Estimators

ERIC Educational Resources Information Center

Reardon, Sean F.

2010-01-01

Instrumental variable estimators hold the promise of enabling researchers to estimate the effects of educational treatments that are not (or cannot be) randomly assigned but that may be affected by randomly assigned interventions. Examples of the use of instrumental variables in such cases are increasingly common in educational and social science…

Effect of Spinal Manipulative Therapy on the Singing Voice.

PubMed

Fachinatto, Ana Paula A; Duprat, André de Campos; Silva, Marta Andrada E; Bracher, Eduardo Sawaya Botelho; Benedicto, Camila de Carvalho; Luz, Victor Botta Colangelo; Nogueira, Maruan Nogueira; Fonseca, Beatriz Suster Gomes

2015-09-01

This study investigated the effect of spinal manipulative therapy (SMT) on the singing voice of male individuals. Randomized, controlled, case-crossover trial. Twenty-nine subjects were selected among male members of the Heralds of the Gospel. This association was chosen because it is a group of persons with similar singing activities. Participants were randomly assigned to two groups: (A) chiropractic SMT procedure and (B) nontherapeutic transcutaneous electrical nerve stimulation (TENS) procedure. Recordings of the singing voice of each participant were taken immediately before and after the procedures. After a 14-day period, procedures were switched between groups: participants who underwent SMT on the first day were subjected to TENS and vice versa. Recordings were subjected to perceptual audio and acoustic evaluations. The same recording segment of each participant was selected. Perceptual audio evaluation was performed by a specialist panel (SP). Recordings of each participant were randomly presented thus making the SP blind to intervention type and recording session (before/after intervention). Recordings compiled in a randomized order were also subjected to acoustic evaluation. No differences in the quality of the singing on perceptual audio evaluation were observed between TENS and SMT. No differences in the quality of the singing voice of asymptomatic male singers were observed on perceptual audio evaluation or acoustic evaluation after a single spinal manipulative intervention of the thoracic and cervical spine. Copyright © 2015 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

Metformin for treatment of antipsychotic-induced weight gain: a randomized, placebo-controlled study.

PubMed

Wang, Man; Tong, Jian-hua; Zhu, Gang; Liang, Guang-ming; Yan, Hong-fei; Wang, Xiu-zhen

2012-06-01

To evaluate the efficacy of metformin for treatment of antipsychotic-induced weight gain. Seventy-two patients with first-episode schizophrenia who gained more than 7% of their predrug weight were randomly assigned to receive 1000 mg/d of metformin or placebo in addition to their ongoing treatment for 12 weeks using a double-blind study design. The primary outcome was change in body weight. The secondary outcomes included changes in body mass index, fasting glucose and insulin, and insulin resistance index. Of the 72 patients who were randomly assigned, 66 (91.6%) completed treatments. The body weight, body mass index, fasting insulin and insulin resistance index decreased significantly in the metformin group, but increased in the placebo group during the 12-week follow-up period. Significantly more patients in the metformin group lost their baseline weight by more than 7%, which was the cutoff for clinically meaningful weight loss. Metformin was tolerated well by majority patients. Metformin was effective and safe in attenuating antipsychotic-induced weight gain and insulin resistance in first-episode schizophrenia patients. Patients displayed good adherence to metformin. Copyright © 2012 Elsevier B.V. All rights reserved.

SMS text pre-notification and delivery of reminder e-mails to increase response rates to postal questionnaires in the SUSPEND trial: a factorial design, randomised controlled trial.

PubMed

Starr, Kathryn; McPherson, Gladys; Forrest, Mark; Cotton, Seonaidh C

2015-07-08

Patient-reported outcomes are vital in informing randomised controlled trials (RCTs) and health-care interventions and policies from the patient's perspective. However, participant non-response may introduce bias and can affect the generalisability of the trial. This study evaluates two interventions aimed at increasing response rates to postal questionnaires within a large, UK-wide RCT: pre-notification via short messenger service (SMS) text prior to sending the initial mailing of trial questionnaires versus no pre-notification; for non-responders to the initial mailing of the questionnaires, an e-mail reminder (containing a hyperlink to complete the questionnaire online) versus a postal reminder. This study is a 2 × 2 partial factorial design RCT nested within an RCT of medical expulsive therapy for ureteric stone disease. Participants who supplied a mobile telephone number were randomly assigned to receive an SMS text pre-notification of questionnaire delivery or no pre-notification. Those who supplied an e-mail address were randomly assigned to receive a questionnaire reminder by e-mail or post. Participants could be randomly assigned to the pre-notification comparison or the reminder comparison or both. The primary outcome measure was response rate at each questionnaire time point. Four hundred eighteen participants were randomly assigned to the SMS pre-notification comparison (80% were male, and the mean age was 41 years with a standard deviation (SD) of 11.1). The intervention had no effect on response rate at either questionnaire time point. In subgroup analyses, SMS pre-notification increased response rates in women but only at the first questionnaire time point. One hundred nineteen participants were randomly assigned to the reminder comparison (80% were male, and the mean age was 42 years with an SD of 12.1). There was no difference in response rate in those who received an e-mail reminder compared with those who received a postal reminder. SMS text pre-notification of questionnaire delivery and email delivery of questionnaire reminders did not improve response rates. There was some evidence to suggest that SMS text pre-notification may be effective in women, and further studies to investigate this may be warranted. E-mail reminders for participants to return their postal questionnaire could be advantageous given that response rates were similar following either type of reminder and the low cost of delivering an e-mail compared with a postal reminder. This is a substudy of the SUSPEND trial (ISCTRN69423238) (18 Nov. 2010).

Effect of rumen-undegradable protein supplementation and fresh forage composition on nitrogen utilization of dairy ewes.

PubMed

Mikolayunas, C; Thomas, D L; Armentano, L E; Berger, Y M

2011-01-01

Previous trials with dairy ewes fed stored feeds indicate a positive effect of rumen-undegradable protein (RUP) supplementation on milk yield. However, dairy sheep production in the United States is primarily based on grazing mixed grass-legume pastures, which contain a high proportion of rumen-degradable protein. Two trials were conducted to evaluate the effects of high-RUP protein supplementation and fresh forage composition on milk yield and N utilization of lactating dairy ewes fed in confinement or on pasture. In a cut-and-carry trial, 16 multiparous dairy ewes in mid-lactation were randomly assigned to 8 pens of 2 ewes each. Pens were randomly assigned 1 of 2 protein supplementation treatments, receiving either 0.0 or 0.3 kg of a high-RUP protein supplement (Soy Pass, LignoTech USA Inc., Rothschild, WI) per day. Within supplementation treatment, pens were randomly assigned to 1 of 4 forage treatments, which were applied in a 4×4 Latin square design for 10-d periods. Forage treatments included the following percentages of orchardgrass:alfalfa dry matter: 25:75, 50:50, 75:25, and 100:0. No interactions were observed between supplement and forage treatments. Supplementation with a high-RUP source tended to increase milk yield by 9%. Milk yield, milk protein yield, milk urea N, and urinary urea N excretion increased linearly with increased percentage of alfalfa. Milk N efficiency was greatest on the 100% orchardgrass diet. In a grazing trial, 12 multiparous dairy ewes in mid lactation were randomly assigned to 3 groups of 4 ewes each. Within group, 2 ewes were randomly assigned to receive either 0.0 or 0.3 kg of a high-RUP protein supplement (SoyPlus, West Central Cooperative, Ralston, IA) per day. Grazing treatments were arranged in a 3×3 Latin square design and applied to groups for 10-d periods. Ewes grazed paddocks that contained the following percentages of surface area of pure stands of orchardgrass:alfalfa: 50:50, 75:25, and 100:0. No interactions were found between supplement and forage treatments. Milk yield, milk protein yield, and milk urea N increased linearly with increased percentage of alfalfa in the paddock. In conclusion, supplementing with high-RUP protein tended to increase milk yield and increasing the proportion of alfalfa in the diet increased dry matter intake, milk yield, and protein yield of lactating dairy ewes fed or grazing fresh forage. Copyright © 2011 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

The I Don't Know Option in the Vocabulary Size Test

ERIC Educational Resources Information Center

Zhang, Xian

2013-01-01

The current study evaluates guessing behaviors in a vocabulary size test (VST) and examines whether including an "I don't know" in a VST may have an impact on the results of the test. One-hundred-fifty first-year students at a university in China took part in the study. They were randomly assigned to three groups. Each group took a…

Comparison of the Effectiveness of Two Forms of the Enhancing Relationships in School Communities Project for Promoting Cooperative Conflict Resolution Education in Australian Primary Schools

ERIC Educational Resources Information Center

Trinder, Margot; Wertheim, Eleanor H.; Freeman, Elizabeth; Sanson, Ann; Richardson, Shanel; Hunt, Sue

2010-01-01

This study evaluated the Enhancing Relationships in School Communities (ERIS) Project which aimed to promote constructive conflict resolution (CR) in Australian primary school communities through professional development for core teams of three-five staff (n = 33 teachers). Twelve schools were randomly assigned to a full intervention (FI) group or…

Evaluating a Multidimensional Reading Comprehension Program and Reconsidering the Lowly Reputation of Tests of Near Transfer

ERIC Educational Resources Information Center

Fuchs, Douglas; Hendricks, Emma; Walsh, Meagan E.; Fuchs, Lynn S.; Gilbert, Jennifer K.; Zhang Tracy, Wen; Patton, Samuel, III.; Davis, Nicole; Kim, Wooliya; Elleman, Amy M.; Peng, Peng

2018-01-01

We conducted a 14-week experimental study of 2 versions of a relatively comprehensive RC intervention that involved 50 classroom teachers, 15 tutors, and 120 children drawn in equal proportions from grades 3 and 5 in 13 schools in a large urban school district. Students were randomly assigned in equal numbers to the 2 tutoring conditions and a…

Evaluating a Multidimensional Reading Comprehension Program and Reconsidering the Lowly Reputation of Tests of Near-Transfer

ERIC Educational Resources Information Center

Fuchs, Douglas; Hendricks, Emma; Walsh, Meagan E.; Fuchs, Lynn S.; Gilbert, Jennifer K.; Zhang Tracy, Wen; Patton, Samuel, III; Davis-Perkins, Nicole; Kim, Wooliya; Elleman, Amy M.; Peng, Peng

2018-01-01

We conducted a 14-week experimental study of 2 versions of a relatively comprehensive RC intervention that involved 50 classroom teachers, 15 tutors, and 116 children drawn in equal proportions from grades 3 and 5 in 13 schools in a large urban school district. Students were randomly assigned in equal numbers to the two tutoring conditions and a…

Effect of supplementing orchardgrass herbage with a total mixed ration or flaxseed fermentation profile and bacterial protein synthesis in continuous culture

USDA-ARS?s Scientific Manuscript database

A 4-unit dual-flow continuous culture fermentor system was used to evaluate the effects of herbage, a total mixed ration (TMR) and flaxseed on nutrient digestibility and microbial N synthesis. Treatments were randomly assigned to fermentors in a 4 x 4 Latin square design. Each fermentor was fed a to...

Opening Doors to Student Success: A Synthesis of Findings from an Evaluation at Six Community Colleges. Policy Brief

ERIC Educational Resources Information Center

Scrivener, Susan; Coghlan, Erin

2011-01-01

Only one-third of all students who enter community colleges with the intent to earn a degree or certificate actually meet this goal within six years. MDRC launched the Opening Doors Demonstration in 2003--the first large-scale random assignment study in a community college setting--to tackle this problem. Partnering with six community colleges,…

Reengaging New York City's Disconnected Youth through Work: Implementation and Early Impacts of the Young Adult Internship Program. OPRE Report 2017-22

ERIC Educational Resources Information Center

Skemer, Melanie; Sherman, Arielle; Williams, Sonya; Cummings, Danielle

2017-01-01

This report presents implementation and early impact results from a random assignment evaluation of the Young Adult Internship Program (YAIP), a subsidized employment program for young people in New York City who have become disconnected from school and work. Operated by various provider agencies, YAIP offers disconnected youth between the ages of…

Contributions of Platform Motion to Simulator Training Effectiveness: Study II--Aerobatics. Interim Report for Period March 1976-November 1977.

ERIC Educational Resources Information Center

Martin, Elizabeth L.; Waag, Wayne L.

A transfer-of-training design was used to evaluate the contributions of simulator training with synergistic six-degrees-of-freedom platform motion to aerobatic skills acquisition in the novice pilot. Thirty-six undergraduate pilot trainees were randomly assigned to one of three treatment groups: motion, no-motion, and control. Those in the control…

Group size alters postures, and maintenance, oral, locomotor and social behaviors of veal calves

USDA-ARS?s Scientific Manuscript database

The objective of this study was to evaluate the effect of group size on behavior of veal calves. Holstein-Friesian bull calves (n = 168; 44 ± 3 d of age), were randomly assigned to 1 of 3 treatments of group housing with 2, 4, or 8 calves per pen (1.82 m2 per calf for all groups). Behavior was obser...

A Comparative Study of a Team Vs. a Non-Team Teaching Approach in High School Biology.

ERIC Educational Resources Information Center

Monaco, William J.; Szabo, Michael

The purpose of this study was to obtain empirical data for the evaluation of a team approach for teaching biology. A sample of 147 sophomore students was divided into six sections; each section was randomly assigned as control or treatment. The team consisted of three instructors. Each member taught a control group for an entire year. After an…

Reading Partners: The Implementation and Effectiveness of a One-on-One Tutoring Program Delivered by Community Volunteers. Policy Brief

ERIC Educational Resources Information Center

Jacob, Robin Tepper; Smith, Thomas J.; Willard, Jacklyn A.; Rifkin, Rachel E.

2014-01-01

This policy brief summarizes the positive results of a rigorous evaluation of Reading Partners, a widely used program that offers one-on-one tutoring provided by community volunteers to struggling readers in low-income elementary schools. A total of 1,265 students in 19 schools in three states were randomly assigned to receive Reading…

The Effectiveness of a Universal School-Based Programme on Coping and Mental Health: A Randomised, Controlled Study of Zippy' Friends

ERIC Educational Resources Information Center

Holen, Solveig; Waaktaar, Trine; Lervag, Arne; Ystgaard, Mette

2012-01-01

The purpose of this study was to evaluate Zippy's Friends, a universal school programme that aims at strengthening children's coping skills. The sample consisted of 1483 children (aged 7-8 years) from 91 second-grade classes in 35 schools. The schools were matched and randomly assigned to intervention or control conditions. Coping was assessed by…

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…

Effects of continuous infusion of tumor necrosis factor-alpha (TNF) into adipose tissue on glucose and fatty acid metabolism in lactating dairy cattle

USDA-ARS?s Scientific Manuscript database

Late-lactation Holstein cows (n=9/treatment) were used to evaluate effects of TNF-alpha administration on glucose and fatty acid (FA) metabolism. Cows were blocked by feed intake and milk yield and randomly assigned within block to 1 of 3 treatments: control, TNF-alpha, and pair-fed control. Treatme...

Evaluation of the Teacher Incentive Fund: Final Report on Implementation and Impacts of Pay-for-Performance across Four Years: Executive Summary. NCEE 2018-4005

ERIC Educational Resources Information Center

Chiang, Hanley; Speroni, Cecilia; Herrmann, Mariesa; Hallgren, Kristin; Burkander, Paul; Wellington, Alison

2017-01-01

The Teacher Incentive Fund (TIF) provides grants to support performance-based compensation systems for teachers and principals in high-need schools. The study measures the impact of pay-for-performance bonuses as part of a comprehensive compensation system within a large, multisite random assignment study design. The treatment schools were to…

Evaluation of the Teacher Incentive Fund: Final Report on Implementation and Impacts of Pay-for-Performance across Four Years. NCEE 2018-4004

ERIC Educational Resources Information Center

Chiang, Hanley; Speroni, Cecilia; Herrmann, Mariesa; Hallgren, Kristin; Burkander, Paul; Wellington, Alison

2017-01-01

The Teacher Incentive Fund (TIF) provides grants to support performance-based compensation systems for teachers and principals in high-need schools. The study measures the impact of pay-for-performance bonuses as part of a comprehensive compensation system within a large, multisite random assignment study design. The treatment schools were to…

Evaluation of the Teacher Incentive Fund: Implementation and Early Impacts of Pay-for-Performance after One Year. Executive Summary. NCEE 2014-4020

ERIC Educational Resources Information Center

Max, Jeffrey; Constantine, Jill; Wellington, Alison; Hallgren, Kristin; Glazerman, Steven; Chiang, Hanley; Speroni, Cecilia

2014-01-01

The Teacher Incentive Fund (TIF) provides grants to support performance-based compensation systems for teachers and principals in high-need schools. The study measures the impact of pay-for-performance bonuses as part of a comprehensive compensation system within a large, multisite random assignment study design. The treatment schools were to…

Evaluation of Child Health Matters: A Web-Based Tutorial to Enhance School Nurses' Communications with Families about Weight-Related Health

ERIC Educational Resources Information Center

Steele, Ric G.; Wu, Yelena P.; Cushing, Christopher C.; Jensen, Chad D.

2013-01-01

The goal of the current study was to assess the efficacy and acceptability of a web-based tutorial (Child Health Matters, CHM) designed to improve school nurses' communications with families about pediatric weight-related health issues. Using a randomized wait-list control design, a nationally representative sample of school nurses was assigned to…

Understanding the impact of career academy attendance: an application of the principal stratification framework for causal effects accounting for partial compliance.

PubMed

Page, Lindsay C

2012-04-01

Results from MDRC's longitudinal, random-assignment evaluation of career-academy high schools reveal that several years after high-school completion, those randomized to receive the academy opportunity realized a $175 (11%) increase in monthly earnings, on average. In this paper, I investigate the impact of duration of actual academy enrollment, as nearly half of treatment group students either never enrolled or participated for only a portion of high school. I capitalize on data from this experimental evaluation and utilize a principal stratification framework and Bayesian inference to investigate the causal impact of academy participation. This analysis focuses on a sample of 1,306 students across seven sites in the MDRC evaluation. Participation is measured by number of years of academy enrollment, and the outcome of interest is average monthly earnings in the period of four to eight years after high school graduation. I estimate an average causal effect of treatment assignment on subsequent monthly earnings of approximately $588 among males who remained enrolled in an academy throughout high school and more modest impacts among those who participated only partially. Different from an instrumental variables approach to treatment non-compliance, which allows for the estimation of linear returns to treatment take-up, the more general framework of principal stratification allows for the consideration of non-linear returns, although at the expense of additional model-based assumptions.

Randomized Trial of Periodic Presumptive Treatment With High-Dose Intravaginal Metronidazole and Miconazole to Prevent Vaginal Infections in HIV-negative Women

PubMed Central

McClelland, R. Scott; Balkus, Jennifer E.; Lee, Jeannette; Anzala, Omu; Kimani, Joshua; Schwebke, Jane; Bragg, Vivian; Lensing, Shelly; Kavak, Lale

2015-01-01

Background. Vaginal infections are common, frequently recur, and may increase women's risk for sexually transmitted infections (STIs). We tested the efficacy of a novel regimen to prevent recurrent vaginal infections. Methods. Human immunodeficiency virus (HIV)–negative women 18–45 years old with 1 or more vaginal infections, including bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), or Trichomonas vaginalis (TV), were randomly assigned to receive vaginal suppositories containing metronidazole 750 mg plus miconazole 200 mg or matching placebo for 5 consecutive nights each month for 12 months. Primary endpoints, evaluated every 2 months, were BV (Gram stain) and VVC (positive wet mount and culture). Results. Participants (N = 234) were randomly assigned to the intervention (N = 118) or placebo (N = 116) arm. Two hundred seventeen (93%) women completed an end-of-study evaluation. The intervention reduced the proportion of visits with BV compared to placebo (21.2% vs 32.5%; relative risk [RR] 0.65, 95% confidence interval [CI] .48–.87). In contrast, the proportion of visits with VVC was similar in the intervention (10.4%) versus placebo (11.3%) arms (RR 0.92, 95% CI .62–1.37). Conclusions. Monthly treatment with intravaginal metronidazole plus miconazole reduced the proportion of visits with BV during 12 months of follow-up. Further study will be important to determine whether this intervention can reduce women's risk of STIs. PMID:25526757

The effect of topical application of pure honey on radiation-induced mucositis: a randomized clinical trial.

PubMed

Motallebnejad, M; Akram, S; Moghadamnia, A; Moulana, Z; Omidi, S

2008-03-01

Radiation-induced mucositis is an early effect of head and neck radiotherapy. Mucositis can cause ulcers, and patients may experience pain and dysphasia which need treatment. The aim of this study is to evaluate the effect of pure natural honey on radiation induced mucositis. In this randomized single blind (examiner blind) clinical trial 40 patients with head and neck cancer requiring radiation to the oropharyngeal mucosa were randomly assigned to two groups. Twenty patients assigned to the study group received honey, while both the study and control groups received standard head and neck radiation therapy based on a standard protocol. In the study group patients were instructed to take 20 ml of honey 15 minutes before radiation therapy, then again at intervals of 15 minutes and six hours after radiation. In the control group patients were instructed to rinse with 20 ml of saline before and after radiation. Patients were evaluated weekly for progression of mucositis using the Oral Mucositis Assessing Scale (OMAS). Data were analyzed using the independent t-test, Mann-Whitney, and Friedman tests. A significant reduction in mucositis among honey-received patients compared with controls (p=0.000) occurred. Within the limits of this study the results showed the application of natural honey is effective in managing radiation induced mucositis. Natural honey is a product with rich nutritional qualities that could be a pleasant, simple, and economic modality for the management of radiation mucositis.

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…

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…

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…

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.

Evaluation of a simplified modified Atkins diet for use by parents with low levels of literacy in children with refractory epilepsy: A randomized controlled trial.

PubMed

Sharma, Suvasini; Goel, Shaiphali; Jain, Puneet; Agarwala, Anuja; Aneja, Satinder

2016-11-01

This study was planned to develop and evaluate a simple, easy-to-understand variation of the modified Atkins diet, for use by parents with low levels of literacy in children with refractory epilepsy. This study was conducted in two phases. In the first phase, a simplified version of the modified Atkins diet was developed. In the second phase this was evaluated in children aged 2-14 years who had daily seizures despite the appropriate use of at least two anticonvulsant drugs, in an open-label randomized-controlled-trial. Children were randomized to receive either the simplified modified Atkins diet or no dietary intervention for a period of 3 months with the ongoing anticonvulsant medications being continued unchanged in both the groups. Reduction in seizure frequency was the primary outcome-measure. Data was analyzed using intention to treat approach. Adverse effects were also studied. (Clinical trial identifier NCT0189989). Forty-one children were randomly assigned to the diet-group, and 40 were assigned to the control-group. Two patients discontinued the diet during the study period. The proportion of children with>50% seizure reduction was significantly higher in the diet group as compared to the control group (56.1% vs 7.5%, p<0.0001). The proportion of children with 90% seizure reduction was also higher in the diet group (19.5% vs 2%, p=0.09). Six children in the diet group were seizure free at 3 months compared with two in the control group (p=0.26). At 3 months, 6 children had constipation and 5 had weight loss. A simplified version of the modified Atkins diet was developed for use by parents with low levels literacy. This diet was found to be feasible, efficacious and well tolerated in children with refractory epilepsy. Copyright © 2016 Elsevier B.V. All rights reserved.

Internet-based guided self-help for glioma patients with depressive symptoms: design of a randomized controlled trial

PubMed Central

2014-01-01

Background Among glioma patients, depression is estimated to be more prevalent than in both the general population and the cancer patient population. This can have negative consequences for both patients and their primary informal caregivers (e.g., a spouse, family member or close friend). At present, there is no evidence from randomized controlled trials for the effectiveness of psychological treatment for depression in glioma patients. Furthermore, the possibility of delivering mental health care through the internet has not yet been explored in this population. Therefore, a randomized controlled trial is warranted to evaluate the effects of an internet-based, guided self-help intervention for depressive symptoms in glioma patients. Methods/design The intervention is based on problem-solving therapy. An existing 5-week course is adapted for use by adult glioma patients with mild to moderate depressive symptoms (Center for Epidemiology Studies Depression Scale score ≥12). Sample size calculations yield 126 glioma patients to be included, who are randomly assigned to either the intervention group or a waiting list control group. In addition, we aim to include 63 patients with haematological cancer in a non-central nervous system malignancy control group. Assessments take place at baseline, after 6 and 12 weeks, and after 6 and 12 months. Primary outcome measure is the change in depressive symptoms. Secondary outcome measures include health-related quality of life, fatigue, costs and patient satisfaction. In addition, all patients are asked to assign a primary informal caregiver, who does not participate in the intervention but who is asked to complete similar assessments. Their mood, health-related quality of life and fatigue is evaluated as well. Discussion This is the first study to evaluate the effects of problem-solving therapy delivered through the internet as treatment for depressive symptoms in glioma patients. If proven effective, this treatment will contribute to the mental health care of glioma patients in clinical practice. Trial registration Netherlands Trial Register NTR3223 PMID:24721108

Potential surrogate endpoints for prostate cancer survival: analysis of a phase III randomized trial.

PubMed

Ray, Michael E; Bae, Kyounghwa; Hussain, Maha H A; Hanks, Gerald E; Shipley, William U; Sandler, Howard M

2009-02-18

The identification of surrogate endpoints for prostate cancer-specific survival may shorten the length of clinical trials for prostate cancer. We evaluated distant metastasis and general clinical treatment failure as potential surrogates for prostate cancer-specific survival by use of data from the Radiation Therapy and Oncology Group 92-02 randomized trial. Patients (n = 1554 randomly assigned and 1521 evaluable for this analysis) with locally advanced prostate cancer had been treated with 4 months of neoadjuvant and concurrent androgen deprivation therapy with external beam radiation therapy and then randomly assigned to no additional therapy (control arm) or 24 additional months of androgen deprivation therapy (experimental arm). Data from landmark analyses at 3 and 5 years for general clinical treatment failure (defined as documented local disease progression, regional or distant metastasis, initiation of androgen deprivation therapy, or a prostate-specific antigen level of 25 ng/mL or higher after radiation therapy) and/or distant metastasis were tested as surrogate endpoints for prostate cancer-specific survival at 10 years by use of Prentice's four criteria. All statistical tests were two-sided. At 3 years, 1364 patients were alive and contributed data for analysis. Both distant metastasis and general clinical treatment failure at 3 years were consistent with all four of Prentice's criteria for being surrogate endpoints for prostate cancer-specific survival at 10 years. At 5 years, 1178 patients were alive and contributed data for analysis. Although prostate cancer-specific survival was not statistically significantly different between treatment arms at 5 years (P = .08), both endpoints were consistent with Prentice's remaining criteria. Distant metastasis and general clinical treatment failure at 3 years may be candidate surrogate endpoints for prostate cancer-specific survival at 10 years. These endpoints, however, must be validated in other datasets.

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.

Subjective and objective measurements of postoperative pain in cats.

PubMed

Cambridge, A J; Tobias, K M; Newberry, R C; Sarkar, D K

2000-09-01

To evaluate the ability of various subjective and objective measurements to determine the presence and degree of postoperative pain in cats. Randomized controlled prospective clinical study. 18 healthy client-owned cats. Cats were randomly assigned to 3 groups of 6: control, tenectomy, and onychectomy. Jugular catheters were placed the day prior to surgery. All surgeries were performed by the same surgeon, and all observations were made by the same blinded trained observer. One hour prior to surgery and at assigned intervals for 36 hours after surgery, heart rate, respiratory rate, and rectal temperature were measured. Scores were assigned for 3 interaction responses, including response to palpation, by use of simple descriptive scales, and to 2 pain assessments by use of visual analogue scales. Blood was collected to measure plasma beta-endorphin and cortisol concentrations. Butorphanol was administered to all cats before surgery and to any cat subjectively assessed to be experiencing pain after surgery. Only visual analogue scale scores and response to palpation scores differed significantly between control and surgical groups. Determination of the presence of pain in cats can be made on the basis of observation and interaction by a trained observer. Physiologic measurements, including plasma cortisol and beta-endorphin concentrations, did not differentiate between control cats and cats that underwent surgery.

Entertainment education for breast cancer surgery decisions: a randomized trial among patients with low health literacy.

PubMed

Jibaja-Weiss, Maria L; Volk, Robert J; Granchi, Thomas S; Neff, Nancy E; Robinson, Emily K; Spann, Stephen J; Aoki, Noriaki; Friedman, Lois C; Beck, J Robert

2011-07-01

To evaluate an entertainment-based patient decision aid for early stage breast cancer surgery in low health literacy patients. Newly diagnosed female patients with early stage breast cancer from two public hospitals were randomized to receive an entertainment-based decision aid for breast cancer treatment along with usual care (intervention arm) or to receive usual care only (control arm). Pre-decision (baseline), pre-surgery, and 1-year follow-up assessments were conducted. Patients assigned to the intervention arm of the study were more likely than the controls to choose mastectomy rather than breast-conserving surgery; however, they appeared better informed and clearer about their surgical options than women assigned to the control group. No differences in satisfaction with the surgical decision or the decision-making process were observed between the patients who viewed the intervention and those assigned to the control group. Entertainment education may be a desirable strategy for informing lower health literate women about breast cancer surgery options. Incorporating patient decision aids, particularly computer-based decision aids, into standard clinical practice remains a challenge; however, patients may be directed to view programs at home or at public locations (e.g., libraries, community centers). Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Discrimination of fish populations using parasites: Random Forests on a 'predictable' host-parasite system.

PubMed

Pérez-Del-Olmo, A; Montero, F E; Fernández, M; Barrett, J; Raga, J A; Kostadinova, A

2010-10-01

We address the effect of spatial scale and temporal variation on model generality when forming predictive models for fish assignment using a new data mining approach, Random Forests (RF), to variable biological markers (parasite community data). Models were implemented for a fish host-parasite system sampled along the Mediterranean and Atlantic coasts of Spain and were validated using independent datasets. We considered 2 basic classification problems in evaluating the importance of variations in parasite infracommunities for assignment of individual fish to their populations of origin: multiclass (2-5 population models, using 2 seasonal replicates from each of the populations) and 2-class task (using 4 seasonal replicates from 1 Atlantic and 1 Mediterranean population each). The main results are that (i) RF are well suited for multiclass population assignment using parasite communities in non-migratory fish; (ii) RF provide an efficient means for model cross-validation on the baseline data and this allows sample size limitations in parasite tag studies to be tackled effectively; (iii) the performance of RF is dependent on the complexity and spatial extent/configuration of the problem; and (iv) the development of predictive models is strongly influenced by seasonal change and this stresses the importance of both temporal replication and model validation in parasite tagging studies.

Augmentation effect of acupuncture on Bi'nao for hypophasis in patients with Bell's palsy: study protocol for a randomized controlled trial.

PubMed

Li, Xiaoyan; Chen, Chunlan; Zhao, Chuang; Li, Zunyuan; Liang, Wei; Liu, Zhidan

2018-06-11

Hypophasis is one of the most frequently observed sequelae of patients with Bell's palsy, who have not recovered completely, creating a clinical difficulty for physicians. Acupuncture therapy has been widely used to treat Bell's palsy as a reasonable resolution for management of symptoms such as hypophasis. The number of acupuncture points (acu-points) is frequently selected in the approach of acupuncture therapy; however, whether these had high efficiency has not been proved. According to the literature review, Bi'nao was useful for treating eye and eye lipid diseases, which could be proved only by some successful cases. Thus, a randomized controlled trial was designed to evaluate the efficiency of the acu-point Bi'nao. Participants with hypophasis as the major symptom are selected among patients with Bell's palsy and randomly allocated into one of the three groups at a 1:1:1 allocation ratio. All participants receive conventional acupuncture therapy; however, those assigned to the real acupuncture group will be given added acupuncture therapy on the acu-point Bi'nao, while those assigned to the sham acupuncture group were given extra acupuncture therapy on the sham Bi'nao as a placebo. The efficacy of the acupuncture therapy on the acu-point Bi'nao for hypophasis will be evaluated by Eye Crack Width Measurement (ECWM) and Eyelid Strength Assessment (ESA) before and after therapy. This is the first study assessing the safety and efficiency of Bi'nao in treating the hypophasis of patients with Bell's palsy that might support the application of this acupuncture therapy. However, evaluating hypophasis is challenging, and, thus, ECWM and ESA were applied to measure the eyelid movement. Chinese Clinical Trials Registry, ChiCTR-INR-17012955 . Registered on 12 October 2017.

Favorable effects of insulin sensitizers pertinent to peripheral arterial disease in type 2 diabetes: results from the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial.

PubMed

Althouse, Andrew D; Abbott, J Dawn; Sutton-Tyrrell, Kim; Forker, Alan D; Lombardero, Manuel S; Buitrón, L Virginia; Pena-Sing, Ivan; Tardif, Jean-Claude; Brooks, Maria Mori

2013-10-01

The aim of this manuscript was to report the risk of incident peripheral arterial disease (PAD) in a large randomized clinical trial that enrolled participants with stable coronary artery disease and type 2 diabetes and compare the risk between assigned treatment arms. The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial randomly assigned participants to insulin sensitization (IS) therapy versus insulin-providing (IP) therapy for glycemic control. Results showed similar 5-year mortality in the two glycemic treatment arms. In secondary analyses reported here, we examine the effects of treatment assignment on the incidence of PAD. A total of 1,479 BARI 2D participants with normal ankle-brachial index (ABI) (0.91-1.30) were eligible for analysis. The following PAD-related outcomes are evaluated in this article: new low ABI≤0.9, a lower-extremity revascularization, lower-extremity amputation, and a composite of the three outcomes. During an average 4.6 years of follow-up, 303 participants experienced one or more of the outcomes listed above. Incidence of the composite outcome was significantly lower among participants assigned to IS therapy than those assigned to IP therapy (16.9 vs. 24.1%; P<0.001). The difference was significant in time-to-event analysis (hazard ratio 0.66 [95% CI 0.51-0.83], P<0.001) and remained significant after adjustment for in-trial HbA1c (0.76 [0.59-0.96], P=0.02). In participants with type 2 diabetes who are free from PAD, a glycemic control strategy of insulin sensitization may be the preferred therapeutic strategy to reduce the incidence of PAD and subsequent outcomes.

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

Effect of intradermal human recombinant copper-zinc superoxide dismutase on random pattern flaps in rats.

PubMed

Schein, Ophir; Westreich, Melvyn; Shalom, Avshalom

2013-09-01

Studies have focused on enhancing flap viability using superoxide dismutase (SOD), but only a few used SOD from human origin, and most gave the compound systemically. We evaluated the ability of SOD to improve random skin flap survival using human recombinant copper-zinc superoxide dismutase (Hr-CuZnSOD) in variable doses, injected intradermally into the flap. Seventy male Sprague Dawley rats were randomly assigned into 4 groups. Cephalic random pattern flaps were elevated on their backs and intradermal injections of different dosages of Hr-CuZnSOD were given 15 minutes before surgery. Flap survival was evaluated by fluorescein fluorescence. Analysis of variance (ANOVA) and t test statistical analyses were performed. Flap survival in all treated groups was significantly better than in the controls. The beneficial effect of HR-CuZnSOD on flap survival is attained when it is given intradermally into the flap tissue. Theoretically, Hr-CuZnSOD delivered with local anesthetics used in flap elevation may be a valuable clinical tool. Copyright © 2012 Wiley Periodicals, Inc.

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

PubMed Central

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

2016-01-01

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

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

PubMed

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

2016-09-01

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

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)…

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…

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

Evaluation of Automatically Assigned Job-Specific Interview Modules

PubMed Central

Friesen, Melissa C.; Lan, Qing; Ge, Calvin; Locke, Sarah J.; Hosgood, Dean; Fritschi, Lin; Sadkowsky, Troy; Chen, Yu-Cheng; Wei, Hu; Xu, Jun; Lam, Tai Hing; Kwong, Yok Lam; Chen, Kexin; Xu, Caigang; Su, Yu-Chieh; Chiu, Brian C. H.; Ip, Kai Ming Dennis; Purdue, Mark P.; Bassig, Bryan A.; Rothman, Nat; Vermeulen, Roel

2016-01-01

Objective: In community-based epidemiological studies, job- and industry-specific ‘modules’ are often used to systematically obtain details about the subject’s work tasks. The module assignment is often made by the interviewer, who may have insufficient occupational hygiene knowledge to assign the correct module. We evaluated, in the context of a case–control study of lymphoid neoplasms in Asia (‘AsiaLymph’), the performance of an algorithm that provided automatic, real-time module assignment during a computer-assisted personal interview. Methods: AsiaLymph’s occupational component began with a lifetime occupational history questionnaire with free-text responses and three solvent exposure screening questions. To assign each job to one of 23 study-specific modules, an algorithm automatically searched the free-text responses to the questions ‘job title’ and ‘product made or services provided by employer’ using a list of module-specific keywords, comprising over 5800 keywords in English, Traditional and Simplified Chinese. Hierarchical decision rules were used when the keyword match triggered multiple modules. If no keyword match was identified, a generic solvent module was assigned if the subject responded ‘yes’ to any of the three solvent screening questions. If these question responses were all ‘no’, a work location module was assigned, which redirected the subject to the farming, teaching, health professional, solvent, or industry solvent modules or ended the questions for that job, depending on the location response. We conducted a reliability assessment that compared the algorithm-assigned modules to consensus module assignments made by two industrial hygienists for a subset of 1251 (of 11409) jobs selected using a stratified random selection procedure using module-specific strata. Discordant assignments between the algorithm and consensus assignments (483 jobs) were qualitatively reviewed by the hygienists to evaluate the potential information lost from missed questions with using the algorithm-assigned module (none, low, medium, high). Results: The most frequently assigned modules were the work location (33%), solvent (20%), farming and food industry (19%), and dry cleaning and textile industry (6.4%) modules. In the reliability subset, the algorithm assignment had an exact match to the expert consensus-assigned module for 722 (57.7%) of the 1251 jobs. Overall, adjusted for the proportion of jobs in each stratum, we estimated that 86% of the algorithm-assigned modules would result in no information loss, 2% would have low information loss, and 12% would have medium to high information loss. Medium to high information loss occurred for <10% of the jobs assigned the generic solvent module and for 21, 32, and 31% of the jobs assigned the work location module with location responses of ‘someplace else’, ‘factory’, and ‘don’t know’, respectively. Other work location responses had ≤8% with medium to high information loss because of redirections to other modules. Medium to high information loss occurred more frequently when a job description matched with multiple keywords pointing to different modules (29–69%, depending on the triggered assignment rule). Conclusions: These evaluations demonstrated that automatically assigned modules can reliably reproduce an expert’s module assignment without the direct involvement of an industrial hygienist or interviewer. The feasibility of adapting this framework to other studies will be language- and exposure-specific. PMID:27250109

Evaluation of Automatically Assigned Job-Specific Interview Modules.

PubMed

Friesen, Melissa C; Lan, Qing; Ge, Calvin; Locke, Sarah J; Hosgood, Dean; Fritschi, Lin; Sadkowsky, Troy; Chen, Yu-Cheng; Wei, Hu; Xu, Jun; Lam, Tai Hing; Kwong, Yok Lam; Chen, Kexin; Xu, Caigang; Su, Yu-Chieh; Chiu, Brian C H; Ip, Kai Ming Dennis; Purdue, Mark P; Bassig, Bryan A; Rothman, Nat; Vermeulen, Roel

2016-08-01

In community-based epidemiological studies, job- and industry-specific 'modules' are often used to systematically obtain details about the subject's work tasks. The module assignment is often made by the interviewer, who may have insufficient occupational hygiene knowledge to assign the correct module. We evaluated, in the context of a case-control study of lymphoid neoplasms in Asia ('AsiaLymph'), the performance of an algorithm that provided automatic, real-time module assignment during a computer-assisted personal interview. AsiaLymph's occupational component began with a lifetime occupational history questionnaire with free-text responses and three solvent exposure screening questions. To assign each job to one of 23 study-specific modules, an algorithm automatically searched the free-text responses to the questions 'job title' and 'product made or services provided by employer' using a list of module-specific keywords, comprising over 5800 keywords in English, Traditional and Simplified Chinese. Hierarchical decision rules were used when the keyword match triggered multiple modules. If no keyword match was identified, a generic solvent module was assigned if the subject responded 'yes' to any of the three solvent screening questions. If these question responses were all 'no', a work location module was assigned, which redirected the subject to the farming, teaching, health professional, solvent, or industry solvent modules or ended the questions for that job, depending on the location response. We conducted a reliability assessment that compared the algorithm-assigned modules to consensus module assignments made by two industrial hygienists for a subset of 1251 (of 11409) jobs selected using a stratified random selection procedure using module-specific strata. Discordant assignments between the algorithm and consensus assignments (483 jobs) were qualitatively reviewed by the hygienists to evaluate the potential information lost from missed questions with using the algorithm-assigned module (none, low, medium, high). The most frequently assigned modules were the work location (33%), solvent (20%), farming and food industry (19%), and dry cleaning and textile industry (6.4%) modules. In the reliability subset, the algorithm assignment had an exact match to the expert consensus-assigned module for 722 (57.7%) of the 1251 jobs. Overall, adjusted for the proportion of jobs in each stratum, we estimated that 86% of the algorithm-assigned modules would result in no information loss, 2% would have low information loss, and 12% would have medium to high information loss. Medium to high information loss occurred for <10% of the jobs assigned the generic solvent module and for 21, 32, and 31% of the jobs assigned the work location module with location responses of 'someplace else', 'factory', and 'don't know', respectively. Other work location responses had ≤8% with medium to high information loss because of redirections to other modules. Medium to high information loss occurred more frequently when a job description matched with multiple keywords pointing to different modules (29-69%, depending on the triggered assignment rule). These evaluations demonstrated that automatically assigned modules can reliably reproduce an expert's module assignment without the direct involvement of an industrial hygienist or interviewer. The feasibility of adapting this framework to other studies will be language- and exposure-specific. Published by Oxford University Press on behalf of the British Occupational Hygiene Society 2016.

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

PubMed

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

2017-03-01

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

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

Evaluating the Quantitative Capabilities of Metagenomic Analysis Software.

PubMed

Kerepesi, Csaba; Grolmusz, Vince

2016-05-01

DNA sequencing technologies are applied widely and frequently today to describe metagenomes, i.e., microbial communities in environmental or clinical samples, without the need for culturing them. These technologies usually return short (100-300 base-pairs long) DNA reads, and these reads are processed by metagenomic analysis software that assign phylogenetic composition-information to the dataset. Here we evaluate three metagenomic analysis software (AmphoraNet--a webserver implementation of AMPHORA2--, MG-RAST, and MEGAN5) for their capabilities of assigning quantitative phylogenetic information for the data, describing the frequency of appearance of the microorganisms of the same taxa in the sample. The difficulties of the task arise from the fact that longer genomes produce more reads from the same organism than shorter genomes, and some software assign higher frequencies to species with longer genomes than to those with shorter ones. This phenomenon is called the "genome length bias." Dozens of complex artificial metagenome benchmarks can be found in the literature. Because of the complexity of those benchmarks, it is usually difficult to judge the resistance of a metagenomic software to this "genome length bias." Therefore, we have made a simple benchmark for the evaluation of the "taxon-counting" in a metagenomic sample: we have taken the same number of copies of three full bacterial genomes of different lengths, break them up randomly to short reads of average length of 150 bp, and mixed the reads, creating our simple benchmark. Because of its simplicity, the benchmark is not supposed to serve as a mock metagenome, but if a software fails on that simple task, it will surely fail on most real metagenomes. We applied three software for the benchmark. The ideal quantitative solution would assign the same proportion to the three bacterial taxa. We have found that AMPHORA2/AmphoraNet gave the most accurate results and the other two software were under-performers: they counted quite reliably each short read to their respective taxon, producing the typical genome length bias. The benchmark dataset is available at http://pitgroup.org/static/3RandomGenome-100kavg150bps.fna.

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

Can Virtual Reality Increase the Realism of Role Plays Used to Teach College Women Sexual Coercion and Rape-Resistance Skills?

ERIC Educational Resources Information Center

Jouriles, Ernest N.; McDonald, Renee; Kullowatz, Antje; Rosenfield, David; Gomez, Gabriella S.; Cuevas, Anthony

2009-01-01

The present study evaluated whether virtual reality (VR) can enhance the realism of role plays designed to help college women resist sexual attacks. Sixty-two female undergraduate students were randomly assigned to either the Role Play (RP) or Virtual Role Play (VRP) conditions, which were differentiated only by the use of VR technology in the VRP…

A Replication and Extension of the PEERS Intervention: Examining Effects on Social Skills and Social Anxiety in Adolescents with Autism Spectrum Disorders

ERIC Educational Resources Information Center

Schohl, Kirsten A.; Van Hecke, Amy V.; Carson, Audrey Meyer; Dolan, Bridget; Karst, Jeffrey; Stevens, Sheryl

2014-01-01

This study aimed to evaluate the Program for the Education and Enrichment of Relational Skills (PEERS: Laugeson et al. in "J Autism Dev Disord" 39(4):596-606, 2009). PEERS focuses on improving friendship quality and social skills among adolescents with higher-functioning ASD. 58 participants aged 11-16 years-old were randomly assigned to…

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…

Influence of thermally-oxidized vegetable oils and animal fats on growth performance, liver gene expression, and liver and serum cholesterol and triglycerides in young pigs

USDA-ARS?s Scientific Manuscript database

To evaluate the effect of feeding thermally-oxidized vegetable oils and animal fats on growth performance, liver gene expression, and liver and serum fatty acid and cholesterol concentration in young pigs, 102 barrows (6.67 ± 0.03 kg BW) were divided into 3 groups and randomly assigned to dietary tr...

Effects of a Parent Training Program on the Interactive Skills of Parents of Children with Autism in China

ERIC Educational Resources Information Center

Wang, Peishi

2008-01-01

This study evaluated the effects of a parent training program on the interactive skills of parents of children with autism in the People's Republic of China. Twenty-seven families of children with autism in a northeastern city of China were randomly assigned to either the training or the control group. Parents received a total of 20 h of training…

Replicated Findings of an Evaluation of a Brief Intervention Designed to Prevent High-Risk Drinking among First-Year College Students: Implications for Social Norming Theory

ERIC Educational Resources Information Center

Stamper, Georgia Ann; Smith, Bradley H.; Gant, Rick; Bogle, Kristin E.

2004-01-01

College students were randomly assigned to receive either (a) standard alcohol programming (SAP) or (b) SAP plus an intervention designed to change perceptions of alcohol norms (PAN). Effects of the intervention delivered during one class period (i.e., 55 minutes) were assessed using pre- and post-intervention surveys about personal alcohol use…

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…

The Effects of Computer Technology in Assisting the Development of Literacy in Young Struggling Readers and Spellers

ERIC Educational Resources Information Center

Fasting, Rolf B.; Lyster, Solveig-Alma Halaas

2005-01-01

The aim of the present study is to evaluate the effect of MultiFunk, a computer program designed to assist reading, on the reading and spelling proficiency of struggling readers. Fifty-two below-average readers and spellers, in grades 5, 6 and 7, were randomly assigned as experimental and control groups (N = 26 + 26). In addition, 114 classmates,…

Balancing a U-Shaped Assembly Line by Applying Nested Partitions Method

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

Bhagwat, Nikhil V.

2005-01-01

In this study, we applied the Nested Partitions method to a U-line balancing problem and conducted experiments to evaluate the application. From the results, it is quite evident that the Nested Partitions method provided near optimal solutions (optimal in some cases). Besides, the execution time is quite short as compared to the Branch and Bound algorithm. However, for larger data sets, the algorithm took significantly longer times for execution. One of the reasons could be the way in which the random samples are generated. In the present study, a random sample is a solution in itself which requires assignment ofmore » tasks to various stations. The time taken to assign tasks to stations is directly proportional to the number of tasks. Thus, if the number of tasks increases, the time taken to generate random samples for the different regions also increases. The performance index for the Nested Partitions method in the present study was the number of stations in the random solutions (samples) generated. The total idle time for the samples can be used as another performance index. ULINO method is known to have used a combination of bounds to come up with good solutions. This approach of combining different performance indices can be used to evaluate the random samples and obtain even better solutions. Here, we used deterministic time values for the tasks. In industries where majority of tasks are performed manually, the stochastic version of the problem could be of vital importance. Experimenting with different objective functions (No. of stations was used in this study) could be of some significance to some industries where in the cost associated with creation of a new station is not the same. For such industries, the results obtained by using the present approach will not be of much value. Labor costs, task incompletion costs or a combination of those can be effectively used as alternate objective functions.« less

Evaluation of a workplace treadmill desk intervention: a randomized controlled trial.

PubMed

Schuna, John M; Swift, Damon L; Hendrick, Chelsea A; Duet, Megan T; Johnson, William D; Martin, Corby K; Church, Timothy S; Tudor-Locke, Catrine

2014-12-01

To evaluate the effectiveness of a 3-month treadmill desk intervention in eliciting changes in physical activity and sedentary behavior among overweight/obese office workers. A randomized controlled trial was conducted among overweight/obese office workers (n = 41; mean age = 40.1 ± 10.1 years) at a private workplace. Participants were randomly assigned to a shared-treadmill desk intervention (n = 21) or a usual working condition control group (n = 20). Accelerometer-determined physical activity and sedentary behavior were measured before and after the intervention. Compared with the control group, the intervention group increased daily steps (1622 steps/day; P = 0.013) and light physical activity (1.6 minutes/hour; P = 0.008), and decreased sedentary time (-3.6 minutes/hour; P = 0.047) during working hours. Shared-treadmill desks in the workplace can be effective at promoting favorable changes in light physical activity (specifically 40 to 99 steps/minute) and sedentary behavior among overweight/obese office workers.

Adaptive Designs for Randomized Trials in Public Health

PubMed Central

Brown, C. Hendricks; Have, Thomas R. Ten; Jo, Booil; Dagne, Getachew; Wyman, Peter A.; Muthén, Bengt; Gibbons, Robert D.

2009-01-01

In this article, we present a discussion of two general ways in which the traditional randomized trial can be modified or adapted in response to the data being collected. We use the term adaptive design to refer to a trial in which characteristics of the study itself, such as the proportion assigned to active intervention versus control, change during the trial in response to data being collected. The term adaptive sequence of trials refers to a decision-making process that fundamentally informs the conceptualization and conduct of each new trial with the results of previous trials. Our discussion below investigates the utility of these two types of adaptations for public health evaluations. Examples are provided to illustrate how adaptation can be used in practice. From these case studies, we discuss whether such evaluations can or should be analyzed as if they were formal randomized trials, and we discuss practical as well as ethical issues arising in the conduct of these new-generation trials. PMID:19296774

Evaluation of a Drowning Prevention Program Based on Testimonial Videos: A Randomized Controlled Trial.

PubMed

Shen, Jiabin; Pang, Shulan; Schwebel, David C

2016-06-01

Unintentional drowning is the most common cause of childhood death in rural China. Global intervention efforts offer mixed results regarding the efficacy of educational programs. Using a randomized controlled design, we evaluated a testimonial-based intervention to reduce drowning risk among 280 3rd- and 4th-grade rural Chinese children. Children were randomly assigned to view either testimonials on drowning risk (intervention) or dog-bite risk (control). Safety knowledge and perceived vulnerability were measured by self-report questionnaires, and simulated behaviors in and near water were assessed with a culturally appropriate dollhouse task. Children in the intervention group had improved children's safety knowledge and simulated behaviors but not perceived vulnerability compared with controls. The testimonial-based intervention's efficacy appears promising, as it improved safety knowledge and simulated risk behaviors with water among rural Chinese children. © The Author 2015. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

The Blue Dog: evaluation of an interactive software program to teach young children how to interact safely with dogs.

PubMed

Schwebel, David C; Morrongiello, Barbara A; Davis, Aaron L; Stewart, Julia; Bell, Melissa

2012-04-01

Pre-post-randomized design evaluated The Blue Dog, a dog safety software program. 76 children aged 3.5-6 years completed 3 tasks to evaluate dog safety pre- and postintervention: (a) pictures (recognition of safe/risky behavior), (b) dollhouse (recall of safe behavior via simulated dollhouse scenarios), and (c) live dog (actual behavior with unfamiliar live dog). Following preintervention evaluation, children were randomly assigned to dog or fire safety conditions, each involving 3 weeks of home computer software use. Children using Blue Dog had greater change in recognition of risky dog situations than children learning fire safety. No between-group differences emerged in recall (dollhouse) or engagement (live-dog) in risky behavior. Families enjoyed using the software. Blue Dog taught children knowledge about safe engagement with dogs, but did not influence recall or implementation of safe behaviors. Dog bites represent a significant pediatric injury concern and continued development of effective interventions is needed.

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

Performance evaluation of distributed wavelength assignment in WDM optical networks

NASA Astrophysics Data System (ADS)

Hashiguchi, Tomohiro; Wang, Xi; Morikawa, Hiroyuki; Aoyama, Tomonori

2004-04-01

In WDM wavelength routed networks, prior to a data transfer, a call setup procedure is required to reserve a wavelength path between the source-destination node pairs. A distributed approach to a connection setup can achieve a very high speed, while improving the reliability and reducing the implementation cost of the networks. However, along with many advantages, several major challenges have been posed by the distributed scheme in how the management and allocation of wavelength could be efficiently carried out. In this thesis, we apply a distributed wavelength assignment algorithm named priority based wavelength assignment (PWA) that was originally proposed for the use in burst switched optical networks to the problem of reserving wavelengths of path reservation protocols in the distributed control optical networks. Instead of assigning wavelengths randomly, this approach lets each node select the "safest" wavelengths based on the information of wavelength utilization history, thus unnecessary future contention is prevented. The simulation results presented in this paper show that the proposed protocol can enhance the performance of the system without introducing any apparent drawbacks.

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

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.

The effectiveness of propolis on gingivitis: a randomized controlled trial.

PubMed

Bretz, Walter A; Paulino, Niraldo; Nör, Jacques E; Moreira, Alexandre

2014-12-01

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

Evaluating the use of fibrin glue for sealing low-output enterocutaneous fistulas: study protocol for a randomized controlled trial.

PubMed

Wu, Xiuwen; Ren, Jianan; Wang, Gefei; Wang, Jianzhong; Wang, Feng; Fan, Yueping; Li, Yuanxin; Han, Gang; Zhou, Yanbing; Song, Xiaofei; Quan, Bin; Yao, Min; Li, Jieshou

2015-10-07

The management of an enterocutaneous fistula poses a significant challenge to surgeons and is often associated with a costly hospital stay and long-term discomfort. The use of fibrin glue in the fistula tract has been shown to promote closure of low output enterocutaneous fistulas. Our previous nonrandomized study demonstrated that autologous platelet-rich fibrin glue treatment significantly decreased time to fistula closure and promoted closure rates. However, there are several limitations in the study, which may lead to bias in our conclusion. Thus, a multicenter, randomized, controlled clinical trial is required. The study is designed as a randomized, open-label, three-arm, multicenter study in nine Chinese academic hospitals for evaluating the efficacy and safety of fibrin glue for sealing low-output fistulas. An established number of 171 fistula patients will undergo prospective random assignment to autologous fibrin glue, commercial porcine fibrin sealants or drainage cessation (1:1:1). The primary endpoint is fistula closure time (defined as the interval between the day of enrollment and day of fistula closure) during the 14-day treatment period. To our knowledge, this is the first study to evaluate the safety and efficacy of both autologous and commercial fibrin glue sealing for patients with low-output volume fistulas. NCT01828892 . Registration date: April 2013.

Randomized controlled trial of the efficacy and safety of self-adhesive low-level light therapy in women with primary dysmenorrhea.

PubMed

Hong, Gi-Youn; Shin, Byung-Cheul; Park, Seong-Nam; Gu, Yun-Hee; Kim, Nam-Gyun; Park, Kyoung-Jun; Kim, Soo-Yeon; Shin, Yong-Il

2016-04-01

To evaluate the efficacy and safety of low-level light therapy in women with primary dysmenorrhea. A multicenter prospective, randomized, double-blind, placebo-controlled clinical trial including patients 18-35 years of age with primary dysmenorrhea was undertaken at two university hospitals in South Korea between October 2011 and September 2012. Patients were randomized using a computer-generated sequence to receive low-level light therapy using the Color DNA-WSF device or to receive placebo treatment with a dummy device. The severity of menstrual pain, assessed using a visual analog scale, was the primary outcome and was evaluated at baseline and during every menstrual cycle for 3 months following treatment. Patients who received more than one application of treatment (with a Color DNA-WSF or placebo device) were included in analyses. Patients and investigators were masked to the treatment assignments. Overall, 44 patients were assigned to each group. At the final study visit, the reduction in scores using a visual analog scale was significantly greater in patients who received low-level light therapy (n=41; 4.34±2.22) than among those in the control group (n=38; 1.79±1.73; P<0.001 when adjusted for age) No serious adverse events occurred. Low-level light therapy could be an effective, safe treatment modality for women with primary dysmenorrhea. Clinical Trials.gov: NCT02026206. Copyright © 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Treatment effectiveness of PMTO for children's behavior problems in Iceland: assessing parenting practices in a randomized controlled trial.

PubMed

Sigmarsdóttir, Margrét; Degarmo, David S; Forgatch, Marion S; Guðmundsdóttir, Edda Vikar

2013-12-01

Findings are presented from an Icelandic randomized control trial (RCT) evaluating parent management training - Oregon model (PMTO™), a parent training intervention designed to improve parenting practices and reduce child behavior problems. In a prior report from this effectiveness study that focused on child outcomes, children in the PMTO condition showed greater reductions in reported child adjustment problems relative to the comparison group. The present report focuses on observed parenting practices as the targeted outcome, with risk by treatment moderators also tested. It was hypothesized that mothers assigned to the PMTO condition would show greater gains in pre-post parenting practices relative to controls. The sample was recruited from five municipalities throughout Iceland and included 102 participating families of children with behavior problems. Cases were referred by community professionals and randomly assigned to either PMTO (n = 51) or community services usually offered (n = 51). Child age ranged from 5 to 12 years; 73% were boys. Contrary to expectations, findings showed no main effects for changes in maternal parenting. However, evaluation of risk by treatment moderators showed greater gains in parenting practices for mothers who increased in depressed mood within the PMTO group relative to their counterparts in the comparison group. This finding suggests that PMTO prevented the expected damaging effects of depression on maternal parenting. Failure to find hypothesized main effects may indicate that there were some unobserved factors regarding the measurement and a need to further adapt the global observational procedures to Icelandic culture. © 2013 The Scandinavian Psychological Associations.

The Moderating Role of Mood and Personal Relevance on Persuasive Effects of Gain- and Loss-Framed Health Messages.

PubMed

Wirtz, John G; Sar, Sela; Ghuge, Shreyas

2015-01-01

We predicted that mood would moderate the relation between message framing and two outcome variables, message evaluation and behavioral intention, when the message was personally relevant to the target audience. Participants (N = 242) were randomly assigned to an experimental condition in which a positive or negative mood was induced. Participants then read and evaluated a health message that emphasized potential benefits or risks associated with a vaccine. As predicted, participants who received a loss-framed message reported higher message evaluation and intention scores but only when the message was personally relevant and they were in a positive mood.

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

PubMed Central

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

2016-01-01

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

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

Calibration of Predictor Models Using Multiple Validation Experiments

NASA Technical Reports Server (NTRS)

Crespo, Luis G.; Kenny, Sean P.; Giesy, Daniel P.

2015-01-01

This paper presents a framework for calibrating computational models using data from several and possibly dissimilar validation experiments. The offset between model predictions and observations, which might be caused by measurement noise, model-form uncertainty, and numerical error, drives the process by which uncertainty in the models parameters is characterized. The resulting description of uncertainty along with the computational model constitute a predictor model. Two types of predictor models are studied: Interval Predictor Models (IPMs) and Random Predictor Models (RPMs). IPMs use sets to characterize uncertainty, whereas RPMs use random vectors. The propagation of a set through a model makes the response an interval valued function of the state, whereas the propagation of a random vector yields a random process. Optimization-based strategies for calculating both types of predictor models are proposed. Whereas the formulations used to calculate IPMs target solutions leading to the interval value function of minimal spread containing all observations, those for RPMs seek to maximize the models' ability to reproduce the distribution of observations. Regarding RPMs, we choose a structure for the random vector (i.e., the assignment of probability to points in the parameter space) solely dependent on the prediction error. As such, the probabilistic description of uncertainty is not a subjective assignment of belief, nor is it expected to asymptotically converge to a fixed value, but instead it casts the model's ability to reproduce the experimental data. This framework enables evaluating the spread and distribution of the predicted response of target applications depending on the same parameters beyond the validation domain.

Randomized controlled dissemination study of community-to-clinic navigation to promote CRC screening: Study design and implications.

PubMed

Larkey, Linda; Szalacha, Laura; Herman, Patricia; Gonzalez, Julie; Menon, Usha

2017-02-01

Regular screening facilitates early diagnosis of colorectal cancer (CRC) and reduction of CRC morbidity and mortality. Screening rates for minorities and low-income populations remain suboptimal. Provider referral for CRC screening is one of the strongest predictors of adherence, but referrals are unlikely among those who have no clinic home (common among poor and minority populations). This group randomized controlled study will test the effectiveness of an evidence based tailored messaging intervention in a community-to-clinic navigation context compared to no navigation. Multicultural, underinsured individuals from community sites will be randomized (by site) to receive CRC screening education only, or education plus navigation. In Phase I, those randomized to education plus navigation will be guided to make a clinic appointment to receive a provider referral for CRC screening. Patients attending clinic appointments will continue to receive navigation until screened (Phase II) regardless of initial arm assignment. We hypothesize that those receiving education plus navigation will be more likely to attend clinic appointments (H1) and show higher rates of screening (H2) compared to those receiving education only. Phase I group assignment will be used as a control variable in analysis of screening follow-through in Phase II. Costs per screening achieved will be evaluated for each condition and the RE-AIM framework will be used to examine dissemination results. The novelty of our study design is the translational dissemination model that will allow us to assess the real-world application of an efficacious intervention previously tested in a randomized controlled trial. Copyright © 2016. Published by Elsevier Inc.

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…

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…

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

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

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.

Day hospital as an alternative to inpatient care for cancer patients: a random assignment trial.

PubMed

Mor, V; Stalker, M Z; Gralla, R; Scher, H I; Cimma, C; Park, D; Flaherty, A M; Kiss, M; Nelson, P; Laliberte, L

1988-01-01

A stratified, random-assignment trial of 442 cancer patients was conducted to evaluate medical, psychosocial, and financial outcomes of day hospital treatment as an alternative to inpatient care for certain cancer patients. Eligible patients required: a 4- to 8-hour treatment plan, including chemotherapy and other long-term intravenous (i.v.) treatment; a stable cardiovascular status; mental competence; no skilled overnight nursing; and a helper to assist with home care. Patients were ineligible if standard outpatient treatment was possible. No statistically significant (p less than 0.05) differences were found between the Adult Day Hospital (ADH) and Inpatient care in medical or psychosocial outcomes over the 60-day study period. The major difference was in medical costs--approximately one-third lower for ADH patients (p less than 0.001) than for the Inpatient group. The study demonstrates that day hospital care of medical oncology patients is clinically equivalent to Inpatient care, causes no negative psychosocial effects, and costs less than Inpatient care. Findings support the trend toward dehospitalization of medical treatment.

Evaluation of the effects of performance dentistry on equine rideability: a randomized, blinded, controlled trial.

PubMed

Moine, Sébastien; Flammer, Shannon Axiak; de Jesus Maia-Nussbaumer, Päivi; Klopfenstein Bregger, Micaël D; Gerber, Vincent

2017-12-01

This study attempted to determine: (1) if degree of dental malocclusion assigned prior to dental treatment was associated with equine rideability, assessed using a standardized score and (2) if performance dentistry improved this score. Thirty-eight Franches-Montagnes stallions. All horses were examined and assigned a dental malocclusion score by a veterinary dentist and randomized into two groups: sham treatment (Group S) and performance dentistry including occlusal equilibration (Group D). The horses were ridden twice before and three times after treatment by a professional dressage rider (unaware of treatment allocation). The horses were assigned a rideability score using a 27-point scale. The malocclusion score was compared to the average of the first two rideability scores using Spearman's coefficient of rank. Change in rideability scores over time was assessed by repeated measures ANOVA. Statistical significance was set at P < 0.05. There was no correlation between dental score and rideability score prior to treatment (r s = 0.06, P = 0.73). In addition, there were no differences in the rideability score between treatment groups or as an interaction of treatment group and time (P = 0.93, P = 0.83, respectively). In conclusion, we were unable to show that performance dentistry improved equine rideability assessed by rider scoring. The addition of more objective measurement tools and a longer assessment period may help to scientifically prove what is anecdotally believed.

Credit with Health Education in Benin: A Cluster Randomized Trial Examining Impacts on Knowledge and Behavior

PubMed Central

Karlan, Dean; Thuysbaert, Bram; Gray, Bobbi

2017-01-01

We evaluate whether health education integrated into microcredit lending groups reduces health risks by improving health knowledge and self-reported behaviors among urban and rural borrowers in eastern Benin. In 2007, we randomly assigned 138 villages in the Plateau region of Benin to one of four variations of a group liability credit product, varying lending groups' gender composition and/or inclusion of health education using a 2 × 2 design. Women in villages receiving health education, regardless of gender composition of the groups, showed improved knowledge of malaria and of human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), but not of childhood illness danger signs. No significant changes in health behavior were observed except an increase in HIV/AIDS prevention behavior, a result predominantly driven by an increase in respondents' self-reported ability to procure a condom, likely an indicator of increased perceived access rather than improved preventative behavior. Women in villages assigned to mixed-gender groups had significantly lower levels of social capital, compared with villages assigned to female-only groups. This suggests there may be an important trade-off to consider for interventions seeking improved health outcomes and social capital through provision of services to mixed-gender groups. Although bundling health education with microcredit can expand health education coverage and lower service-delivery costs, the approach may not be sufficient to improve health behaviors. PMID:27895268

Outcomes by Sex Following Treatment Initiation With Atazanavir Plus Ritonavir or Efavirenz With Abacavir/Lamivudine or Tenofovir/Emtricitabine

PubMed Central

Smith, Kimberly Y.; Tierney, Camlin; Mollan, Katie; Venuto, Charles S.; Budhathoki, Chakra; Ma, Qing; Morse, Gene D.; Sax, Paul; Katzenstein, David; Godfrey, Catherine; Fischl, Margaret; Daar, Eric S.; Collier, Ann C.; Bolivar, Hector H.; Navarro, Sandra; Koletar, Susan L.; Gochnour, Diane; Seefried, Edward; Hoffman, Julie; Feinberg, Judith; Saemann, Michelle; Patterson, Kristine; Pittard, Donna; Currin, David; Upton, Kerry; Saag, Michael; Ray, Graham; Johnson, Steven; Santos, Bartolo; Funk, Connie A.; Morgan, Michael; Jackson, Brenda; Tebas, Pablo; Thomas, Aleshia; Kim, Ge-Youl; Klebert, Michael K.; Santana, Jorge L.; Marrero, Santiago; Norris, Jane; Valle, Sandra; Cox, Gary Matthew; Silberman, Martha; Shaik, Sadia; Lopez, Ruben; Vasquez, Margie; Daskalakis, Demetre; Megill, Christina; Shore, Jessica; Taiwo, Babafemi; Goldman, Mitchell; Boston, Molly; Lennox, Jeffrey; del Rio, Carlos; Lane, Timothy W.; Epperson, Kim; Luetkemeyer, Annie; Payne, Mary; Gripshover, Barbara; Antosh, Dawn; Reid, Jane; Adams, Mary; Storey, Sheryl S.; Dunaway, Shelia B.; Gallant, Joel; Wiggins, Ilene; Smith, Kimberly Y.; Swiatek, Joan A.; Timpone, Joseph; Kumar, Princy; Moe, Ardis; Palmer, Maria; Gothing, Jon; Delaney, Joanne; Whitely, Kim; Anderson, Ann Marie; Hammer, Scott M.; Yin, Michael T.; Jain, Mamta; Petersen, Tianna; Corales, Roberto; Hurley, Christine; Henry, Keith; Bordenave, Bette; Youmans, Amanda; Albrecht, Mary; Pollard, Richard B.; Olusanya, Abimbola; Skolnik, Paul R.; Adams, Betsy; Tashima, Karen T.; Patterson, Helen; Ukwu, Michelle; Rogers, Lauren; Balfour, Henry H.; Fox, Kathy A.; Swindells, Susan; Van Meter, Frances; Robbins, Gregory; Burgett-Yandow, Nicole; Davis, Charles E.; Boyce, Colleen; O'Brien, William A.; Casey, Gerianne; Morse, Gene D.; Hsaio, Chiu-Bin; Meier, Jeffrey L.; Stapleton, Jack T.; Mildvan, Donna; Revuelta, Manuel; Currin, David; El Sadr, Wafaa; Loquere, Avelino; El-Daher, Nyef; Johnson, Tina; Gross, Robert; Maffei, Kathyrn; Hughes, Valery; Sturge, Glenn; McMahon, Deborah; Rutecki, Barbara; Wulfsohn, Michael; Cheng, Andrew; Dix, Lynn; Liao, Qiming

2014-01-01

Background. We aimed to evaluate treatment responses to atazanavir plus ritonavir (ATV/r) or efavirenz (EFV) in initial antiretroviral regimens among women and men, and determine if treatment outcomes differ by sex. Methods. We performed a randomized trial of open-label ATV/r or EFV combined with abacavir/lamivudine (ABC/3TC) or tenofovir/emtricitabine (TDF/FTC) in 1857 human immunodeficiency virus type 1–infected, treatment-naive persons enrolled between September 2005 and November 2007 at 59 sites in the United States and Puerto Rico. Associations of sex with 3 primary study endpoints of time to virologic failure, safety, and tolerability events were analyzed using Cox proportional hazards models. Model-based population pharmacokinetic analysis was performed using nonlinear mixed effects modeling (NONMEM version VII). Results. Of 1857 participants, 322 were women. Women assigned to ATV/r had a higher risk of virologic failure with either nucleoside reverse transcriptase inhibitor backbone than women assigned to EFV, or men assigned to ATV/r. The effects of ATV/r and EFV upon safety and tolerability risk did not differ significantly by sex. With ABC/3TC, women had a significantly higher (32%) safety risk compared to men; with TDF/FTC, the safety risk was 20% larger for women compared to men, but not statistically significant. Women had slower ATV clearance and higher predose levels of ATV compared to men. Self-reported adherence did not differ significantly by sex. Conclusions. This is the first randomized clinical trial to identify a significantly earlier time to virologic failure in women randomized to ATV/r compared to women randomized to EFV. This finding has important clinical implications given that boosted protease inhibitors are often favored over EFV in women of childbearing potential. Clinical Trials Registration NCT00118898. PMID:24253247

Randomized Comparison of Systemic Anti-inflammatory Therapy Versus Fluocinolone Acetonide Implant for Intermediate, Posterior and Panuveitis: The Multicenter Uveitis Steroid Treatment Trial

PubMed Central

Kempen, John H.; Altaweel, Michael M.; Holbrook, Janet T.; Jabs, Douglas A.; Louis, Thomas A.; Sugar, Elizabeth A.; Thorne, Jennifer E.

2011-01-01

Objective To compare the relative effectiveness of systemic corticosteroids plus immunosuppression when indicated (systemic therapy) versus fluocinolone acetonide implant (implant therapy) for non-infectious intermediate, posterior or panuveitis (uveitis). Design Randomized controlled parallel superiority trial. Participants Patients with active/recently active uveitis. Methods Participants were randomized (allocation ratio 1:1) to systemic or implant therapy at 23 centers (three countries). Implant-assigned participants with bilateral uveitis were assigned to have each eye that warranted study treatment implanted. Treatment-outcome associations were analyzed by assigned treatment for all eyes with uveitis. Main Outcome Measures Masked examiners measured the primary outcome: change in best-corrected visual acuity from baseline. Secondary outcomes included patient-reported quality of life (QoL), ophthalmologist-graded uveitis activity, and local and systemic complications of uveitis or therapy. Reading Center graders and glaucoma specialists assessing ocular complications were masked. Participants, ophthalmologists, and coordinators were unmasked. Results Among 255 patients randomized to implant and systemic therapy (479 eyes with uveitis), evaluating changes from baseline to 24 months, the implant and systemic therapy groups respectively had +6.0 vs. +3.2 letters' improvement in visual acuity (p=0.16, 95% confidence interval on difference in improvement between groups: −1.2 to +6.7 letters, positive values favoring implant), +11.4 vs. +6.8 units' vision-related QoL improvement (p=0.043), +0.02 vs. −0.02 change in EuroQol-EQ5D health utility (p=0.060), and 12% vs. 29% had active uveitis (p=0.001). Over 24 months, implant-assigned eyes had a higher risk of cataract surgery (80%, hazard ratio (HR) = 3.3, p<0.0001), treatment for elevated intraocular pressure (61%, HR=4.2, p<0.0001), and glaucoma (17%, HR = 4.2, p=0.0008). Systemic-assigned patients had more prescription-requiring infections (0.60 vs. 0.36/person-year, p=0.034), without notable long-term consequences; systemic adverse outcomes otherwise were unusual in both groups, with minimal differences between groups. Conclusion In each treatment group, mean visual acuity improved over 24 months, with neither approach superior to a degree detectable with the study's power. Therefore, the specific advantages and disadvantages identified should dictate selection between the alternative treatments in consideration of individual patients' particular circumstances. Systemic therapy with aggressive use of corticosteroid-sparing immunosuppression was well-tolerated, suggesting that this approach is reasonably safe for local and systemic inflammatory disorders. PMID:21840602

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.

Evaluating a Web-Based Social Anxiety Intervention Among University Students: Randomized Controlled Trial

PubMed Central

McCall, Hugh Cameron; Richardson, Chris G; Helgadottir, Fjola Dogg

2018-01-01

Background 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. Objective 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. Methods 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. Results 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). Conclusions 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. Trial Registration ClinicalTrials.gov NCT02792127; https://clinicaltrials.gov/ct2/show/record/NCT02792127 (Archived by WebCite at http://www.webcitation.org/6xGSRh7MG) PMID:29563078

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...

Circulating Tumor Cells and Response to Chemotherapy in Metastatic Breast Cancer: SWOG S0500

PubMed Central

Smerage, Jeffrey B.; Barlow, William E.; Hortobagyi, Gabriel N.; Winer, Eric P.; Leyland-Jones, Brian; Srkalovic, Gordan; Tejwani, Sheela; Schott, Anne F.; O'Rourke, Mark A.; Lew, Danika L.; Doyle, Gerald V.; Gralow, Julie R.; Livingston, Robert B.; Hayes, Daniel F.

2014-01-01

Purpose Increased circulating tumor cells (CTCs; five or more CTCs per 7.5 mL of whole blood) are associated with poor prognosis in metastatic breast cancer (MBC). A randomized trial of patients with persistent increase in CTCs tested whether changing chemotherapy after one cycle of first-line chemotherapy would improve the primary outcome of overall survival (OS). Patients and Methods Patients with MBC who did not have increased CTCs at baseline remained on initial therapy until progression (arm A). Patients with initially increased CTCs that decreased after 21 days of therapy remained on initial therapy (arm B). Patients with persistently increased CTCs after 21 days of therapy were randomly assigned to continue initial therapy (arm C1) or change to an alternative chemotherapy (arm C2). Results Of 595 eligible and evaluable patients, 276 (46%) did not have increased CTCs (arm A). Of those with initially increased CTCs, 31 (10%) were not retested, 165 were assigned to arm B, and 123 were randomly assigned to arm C1 or C2. No difference in median OS was observed between arm C1 and C2 (10.7 and 12.5 months, respectively; P = .98). CTCs were strongly prognostic. Median OS for arms A, B, and C (C1 and C2 combined) were 35 months, 23 months, and 13 months, respectively (P < .001). Conclusion This study confirms the prognostic significance of CTCs in patients with MBC receiving first-line chemotherapy. For patients with persistently increased CTCs after 21 days of first-line chemotherapy, early switching to an alternate cytotoxic therapy was not effective in prolonging OS. For this population, there is a need for more effective treatment than standard chemotherapy. PMID:24888818

Effect of sanhuangwuji powder, anti-rheumatic drugs, and ginger-partitioned acupoint stimulation on the treatment of rheumatoid arthritis with peptic ulcer: a randomized controlled study.

PubMed

Liu, Defang; Guo, Mingyang; Hu, Yonghe; Liu, Taihua; Yan, Jiao; Luo, Yong; Yun, Mingdong; Yang, Min; Zhang, Jun; Guo, Linglin

2015-06-01

To observe the efficacy and safety of oral sanhuangwuji powder, anti-rheumatic drugs (ARDs), and ginger-partitioned acupoint stimulation at zusanli (ST 36) on the treatment of rheumatoid arthritis (RA) complicated by peptic ulcer. This prospective randomized controlled study included 180 eligible inpatients and outpatients randomly assigned to an ARD treatment (n.= 60), ginger-partitioned stimulation (n = 60), or combination treatment (n = 60). Patients assigned to the ARD group were given oral celecoxib, methotrexate, and esomeprazole. Patients assigned to the ginger-partitioned stimulation group were given ginger-partitioned acupoint stimulation at zusanli (ST 36) in addition to the ARDs. Patients in the combination treatment group were given oral sanhuangwuji powder, ginger-partitioned acupoint stimulation at susanli (ST 36), and ARDs. All patients were followed up for 2 months to evaluate clinical effects and safety. The study was registered in the World Health Organization database at the General Hospital of Chengdu Military Area Command Chinese People's Liberation Army (ChiCTR-TCC12002824). The combination treatment group had significantly greater improvements in RA symptoms, laboratory outcomes, and gastrointestinal symptom scores, compared with the other groups (P < 0.05). The peptic ulcer healing rate in the combination treatment group was significantly greater than that in the ARD treatment group (χ2= 16.875, P < 0.05) and the ginger-partitioned stimulation group (χ2= 6.171, P < 0.05). Combination treatment with ginger-partitioned acupoint stimulation at zusanli (ST 36), oral sanhuangwuji powder, and ARDs had a better clinical effect for RA with complicated peptic ulcer, compared with ARD treatmentalone or in combination with ginger-partitioned acupoint stimulation.

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…

Experiential Teaching Increases Medication Calculation Accuracy Among Baccalaureate Nursing Students.

PubMed

Hurley, Teresa V

Safe medication administration is an international goal. Calculation errors cause patient harm despite education. The research purpose was to evaluate the effectiveness of an experiential teaching strategy to reduce errors in a sample of 78 baccalaureate nursing students at a Northeastern college. A pretest-posttest design with random assignment into equal-sized groups was used. The experiential strategy was more effective than the traditional method (t = -0.312, df = 37, p = .004, 95% CI) with a reduction in calculation errors. Evaluations of error type and teaching strategies are indicated to facilitate course and program changes.

Efficacy and safety of acupuncture for chronic dizziness: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Dizziness is one of the most challenging symptoms in medicine. No medication for dizziness in current use has well-established curative or prophylactic value or is suitable for long-term palliative use. Unconventional remedies, such as acupuncture, should be considered and scientifically evaluated. However, there has been relatively little evidence in randomized controlled clinical trials on acupuncture to treat chronic dizziness. The aim of our study is to evaluate the efficacy and safety of acupuncture in patients with dizziness. Methods/Design This trial is a randomized, single-blind, controlled study. A total of 80 participants will be randomly assigned to two treatment groups receiving acupuncture and sham acupuncture treatment, respectively, for 4 weeks. The primary outcome measures are the Dizziness Handicap Inventory (DHI) and the Vertigo Symptom Scale (VSS). Treatment will be conducted over a period of 4 weeks, at a frequency of two sessions per week. The assessment is at baseline (before treatment initiation), 4 weeks after the first acupuncture session, and 8 weeks after the first acupuncture session. Discussion The results from this study will provide clinical evidence on the efficacy and safety of acupuncture in patients with chronic dizziness. Trial registration International Standard Randomized Controlled Trial Number Register: ISRCTN52695239 PMID:24330810

Psychoeducation to address stigma in black adults referred for mental health treatment: a randomized pilot study.

PubMed

Alvidrez, Jennifer; Snowden, Lonnie R; Rao, Stephen M; Boccellari, Alicia

2009-04-01

Forty-two Black clients referred for outpatient treatment were randomly assigned to receive existing brochures about services or a psychoeducational booklet about stigma based on experiences of Black mental health consumers. At 3-month follow-up, clients reported that both types of information were helpful; there were no significant differences between the types of information on treatment attendance. However, individuals who reported higher perceived treatment need or greater uncertainty about treatment showed greater stigma reduction from the psychoeducation. Findings indicate the need to move beyond "customer satisfaction" to evaluate educational interventions, as well as for greater understanding of differential impact of stigma reduction interventions.

Health and agricultural productivity: Evidence from Zambia.

PubMed

Fink, Günther; Masiye, Felix

2015-07-01

We evaluate the productivity effects of investment in preventive health technology through a randomized controlled trial in rural Zambia. In the experiment, access to subsidized bed nets was randomly assigned at the community level; 516 farmers were followed over a one-year farming period. We find large positive effects of preventative health investment on productivity: among farmers provided with access to free nets, harvest value increased by US$ 76, corresponding to about 14.7% of the average output value. While only limited information was collected on farming inputs, shifts in the extensive and the intensive margins of labor supply appear to be the most likely mechanism underlying the productivity improvements observed. Copyright © 2015 Elsevier B.V. All rights reserved.

Design, conduct, and analyses of Breast International Group (BIG) 1-98: a randomized, double-blind, phase-III study comparing letrozole and tamoxifen as adjuvant endocrine therapy for postmenopausal women with receptor-positive, early breast cancer.

PubMed

Giobbie-Hurder, Anita; Price, Karen N; Gelber, Richard D

2009-06-01

Aromatase inhibitors provide superior disease control when compared with tamoxifen as adjuvant therapy for postmenopausal women with endocrine-responsive early breast cancer. To present the design, history, and analytic challenges of the Breast International Group (BIG) 1-98 trial: an international, multicenter, randomized, double-blind, phase-III study comparing the aromatase inhibitor letrozole with tamoxifen in this clinical setting. From 1998-2003, BIG 1-98 enrolled 8028 women to receive monotherapy with either tamoxifen or letrozole for 5 years, or sequential therapy of 2 years of one agent followed by 3 years of the other. Randomization to one of four treatment groups permitted two complementary analyses to be conducted several years apart. The first, reported in 2005, provided a head-to-head comparison of letrozole versus tamoxifen. Statistical power was increased by an enriched design, which included patients who were assigned sequential treatments until the time of the treatment switch. The second, reported in late 2008, used a conditional landmark approach to test the hypothesis that switching endocrine agents at approximately 2 years from randomization for patients who are disease-free is superior to continuing with the original agent. The 2005 analysis showed the superiority of letrozole compared with tamoxifen. The patients who were assigned tamoxifen alone were unblinded and offered the opportunity to switch to letrozole. Results from other trials increased the clinical relevance about whether or not to start treatment with letrozole or tamoxifen, and analysis plans were expanded to evaluate sequential versus single-agent strategies from randomization. Due to the unblinding of patients assigned tamoxifen alone, analysis of updated data will require ascertainment of the influence of selective crossover from tamoxifen to letrozole. BIG 1-98 is an example of an enriched design, involving complementary analyses addressing different questions several years apart, and subject to evolving analytic plans influenced by new data that emerge over time.

Lack of adjunctive benefit of Er:YAG laser in non-surgical periodontal treatment: a randomized split-mouth clinical trial.

PubMed

Rotundo, Roberto; Nieri, Michele; Cairo, Francesco; Franceschi, Debora; Mervelt, Jana; Bonaccini, Daniele; Esposito, Marco; Pini-Prato, Giovanpaolo

2010-06-01

This split-mouth, randomized, clinical trial aimed to evaluate the efficacy of erbium-doped:yttrium-aluminium-garnet (Er:YAG) laser application in non-surgical periodontal treatment. A total of 27 patients underwent four modalities of non-surgical therapy: supragingival debridement; scaling and root planing (SRP)+Er:YAG laser; Er:YAG laser; and SRP. Each strategy was randomly assigned and performed in one of the four quadrants. Clinical outcomes were evaluated at 3 and 6 months. Subjective benefits of patients have been evaluated by means of questionnaires. Six months after therapy, Er:YAG laser showed no statistical difference in clinical attachment gain with respect to supragingival scaling [0.15 mm (95% CI -0.16; 0.46)], while SRP showed a greater attachment gain than the supragingival scaling [0.37 mm (95% CI 0.05; 0.68)]. No difference resulted between Er:YAG laser+SRP and SRP alone [0.05 mm (95% CI -0.25; 0.36)]. The adjunctive use of Er:YAG laser to conventional SRP did not reveal a more effective result than SRP alone. Furthermore, the sites treated with Er:YAG laser showed similar results of the sites treated with supragingival scaling.

Evaluation of the effect of aromatherapy with lavender essential oil on post-tonsillectomy pain in pediatric patients: a randomized controlled trial.

PubMed

Soltani, Rasool; Soheilipour, Saeed; Hajhashemi, Valiollah; Asghari, Gholamreza; Bagheri, Mahdi; Molavi, Mahdi

2013-09-01

To evaluate the effect of aromatherapy with Lavandula angustifolia essential oil on post-tonsillectomy pain in pediatric patients. This was a randomized controlled prospective clinical trial. In this study, 48 post-tonsillectomy patients aged 6-12 years were randomly assigned to two groups (24 patients in each group). After tonsillectomy surgery, all patients received acetaminophen (10-15 mg/kg/dose, PO) every 6h as necessary to relieve pain. The patients of the case group also inhaled lavender essential oil. The frequencies of daily use of acetaminophen and nocturnal awakening due to pain, and pain intensity (evaluated using visual analog scale [VAS]) were recorded for each patient for 3 days after surgery. Finally, the mean values of variables were compared between two groups separately for each post-operative day. The use of lavender essential oil caused statistically significant reduction in daily use of acetaminophen in all three post-operative days but had not significant effects on pain intensity and frequency of nocturnal awakening. Aromatherapy with lavender essential oil decreases the number of required analgesics following tonsillectomy in pediatric patients. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

A Randomized Control Intervention Investigating the Effects of Acute Exercise on Emotional Regulation.

PubMed

Edwards, Meghan K; Rhodes, Ryan E; Loprinzi, Paul D

2017-09-01

Exercise may help to cope with hectic or demanding events after a stressful situation occurs. Limited research has evaluated whether exercise, prior to a stressor, helps to facilitate subsequent emotional regulation. This pilot study addresses this novel paradigm. We employed a randomized controlled trial evaluating the effects of acute exercise on emotional regulation. Participants were randomly assigned to stretch (control group, N = 10), walk (N = 9), or jog (N = 8) for 15-minutes, after which they were exposed to a film clip intended to elicit a negative emotional response. Participants' emotions were monitored before and during exercise, as well as after the film clip. Emotional responses were evaluated using the Exercise Induced Feeling Inventory and Affective Circumplex Scale. A group x time splitplot interaction effect was significant for anger (p = .046) and anxiousness (p = .038). Follow-up analyses showed that only the stretching group (p = .048) had a significantly increased anger score from baseline to post-film clip, suggesting a protective emotional effect from walking and jogging. Exercise was effective in regulating anger and anxiousness after a stressful event. These findings provide evidence for potential preventive effects of exercise in facilitating emotional regulation.

Evaluation of a sexual health approach to prevent HIV among low income, urban, primarily African American women: results of a randomized controlled trial.

PubMed

Robinson, Beatrice Bean E; Uhl, Gary; Miner, Michael; Bockting, Walter O; Scheltema, Karen E; Rosser, B R Simon; Westover, Bonita

2002-06-01

This randomized controlled trial evaluated an innovative culturally specific sexual health intervention-targeting, but not limited to, low-income African American women-in which HIV and sexually transmitted disease prevention strategies were combined with comprehensive sexuality education. The intervention was delivered and evaluated in community-based settings to 218 participants randomly assigned to treatment or a no-treatment control group. Participants were interviewed at pretest and 3 and 9 months after the intervention to assess changes in both sexuality and HIV risk variables. The intervention was effective in improving sexual anatomy knowledge at both 3- and 9-month follow-up. For a subset of women engaging in unprotected sex at pretest, the intervention group reported an increase in positive attitudes toward the female condom at 9-month follow-up. Reasons for the weak treatment effect are discussed in the context of challenges inherent in conducting community-based research with high-risk populations and sensitive topics. Recommendations are provided for improving sample attrition, statistical power, and response bias and for altering the intervention so as to strengthen its impact.

Implementation and Randomized Controlled Trial Evaluation of Universal Postnatal Nurse Home Visiting

PubMed Central

Goodman, W. Benjamin; Murphy, Robert A.; O’Donnell, Karen; Sato, Jeannine; Guptill, Susan

2014-01-01

Objectives. We evaluated whether a brief, universal, postnatal nurse home-visiting intervention can be implemented with high penetration and fidelity, prevent emergency health care services, and promote positive parenting by infant age 6 months. Methods. Durham Connects is a manualized 4- to 7-session program to assess family needs and connect parents with community resources to improve infant health and well-being. All 4777 resident births in Durham, North Carolina, between July 1, 2009, and December 31, 2010, were randomly assigned to intervention and control conditions. A random, representative subset of 549 families received blinded interviews for impact evaluation. Results. Of all families, 80% initiated participation; adherence was 84%. Hospital records indicated that Durham Connects infants had 59% fewer infant emergency medical care episodes than did control infants. Durham Connects mothers reported fewer infant emergency care episodes and more community connections, more positive parenting behaviors, participation in higher quality out-of-home child care, and lower rates of anxiety than control mothers. Blinded observers reported higher quality home environments for Durham Connects than for control families. Conclusions. A brief universal home-visiting program implemented with high penetration and fidelity can lower costly emergency medical care and improve family outcomes. PMID:24354833

Effectiveness of a visual attention retraining program on the driving performance of clients with stroke.

PubMed

Mazer, Barbara L; Sofer, Susan; Korner-Bitensky, Nicol; Gelinas, Isabelle; Hanley, James; Wood-Dauphinee, Sharon

2003-04-01

To compare the effectiveness of a visual attention retraining program using the Useful Field of View (UFOV) with a traditional visuoperception treatment program on the driving performance of clients with stroke. Randomized controlled trial. Rehabilitation hospital located in Quebec, Canada. Ninety-seven individuals referred for driving evaluation after a stroke. Participants were randomized to receive 20 sessions of either UFOV training of visual processing speed, divided attention, and selective attention or traditional computerized visuoperception retraining. Subjects were evaluated with an on-road driving evaluation, visuoperception tests, and the Test of Everyday Attention. An occupational therapist unaware of group assignment conducted all evaluations. Eighty-four participants completed the outcome evaluation. There were no significant differences between groups on any of the outcome measures. There was, however, almost a 2-fold increase (52.4% vs 28.6%) in the rate of success on the on-road driving evaluation after UFOV training for subjects with right-sided lesions. Rehabilitation that targets visual attention skills was not significantly more beneficial than traditional perceptual training in improving the outcome of an on-road driving evaluation. However, results suggest a potential improvement for subjects with right-sided lesions, indicating that training must target specific skills.

The relation between mindfulness and fear of negative evaluation over the course of cognitive behavioral therapy for social anxiety disorder.

PubMed

Burton, Mark; Schmertz, Stefan K; Price, Matthew; Masuda, Akihiko; Anderson, Page L

2013-03-01

This study examined the relation between mindfulness and fear of negative evaluation over the course of nonmindfulness based cognitive-behavioral therapy (CBT) for social anxiety disorder (SAD). We expected that higher levels of mindfulness would be associated with a more positive response to treatment. This study is a secondary report from a randomized controlled trial in which participants (N = 65) diagnosed with SAD were randomly assigned to receive 8 weeks of 1 of 2 manualized treatments (exposure group therapy, n = 33; or virtual reality exposure therapy, n = 32) either immediately or following an 8 week waiting period. Fear of negative evaluation decreased following treatment and was negatively related to mindfulness throughout treatment and follow-up. Mindfulness did not moderate treatment outcome. These findings indicate that while mindfulness is related to fear, it is not a moderator of symptom reduction in nonmindfulness-based treatment. Implications for treatment and future research are discussed. 2012 Wiley Periodicals, Inc

Methodology and Baseline Results From the Evaluation of a Sexuality Education Activity in Mpumalanga and KwaZulu-Natal, South Africa.

PubMed

Speizer, Ilene S; Mandal, Mahua; Xiong, Khou; Hattori, Aiko; Makina-Zimalirana, Ndinda; Kumalo, Faith; Taylor, Stephen; Ndlovu, Muzi S; Madibane, Mathata; Beke, Andy

2018-04-01

In South Africa, adolescents and young adults (ages 15-24) are at risk of HIV, sexually transmitted infections, and unintended pregnancies. Recently, the Department of Basic Education has revised its sexuality education content and teaching strategies (using scripted lessons plans) as part of its life orientation curriculum. This paper presents the methodology and baseline results from the evaluation of the scripted lesson plans and supporting activities. A rigorous cluster-level randomized design with random assignment of schools as clusters is used for the evaluation. Baseline results from grade 8 female and male learners and grade 10 female learners demonstrate that learners are at risk of HIV and early and unintended pregnancies. Multivariable analyses demonstrate that household-level food insecurity and living with an HIV-positive person are associated with sexual experience and pregnancy experience. Implications are discussed for strengthening the current life orientation program for future scale-up by the government of South Africa.

An Evaluation of the Hoʻouna Pono Curriculum: A Pilot Study of Culturally Grounded Substance Abuse Prevention for Rural Hawaiian Youth

PubMed Central

Okamoto, Scott K.; Kulis, Stephen; Helm, Susana; Lauricella, Michela; Valdez, Jessica K.

2016-01-01

This pilot study evaluated the Hoʻouna Pono curriculum, which is a culturally grounded, school-based, drug prevention curriculum tailored to rural Native Hawaiian youth. The curriculum focuses on culturally relevant drug resistance skills training and is aligned with the State of Hawaiʻi academic standards. Six Hawaiʻi Island public middle/intermediate schools randomly assigned to intervention or treatment-as-usual comparison conditions (N = 213) were evaluated in this study. Paired sample t-tests separating intervention and comparison groups were conducted, as well as mixed models that adjusted for random effects (nesting) at the school level. Findings suggested that the curriculum was effective in maintaining youths’ use of culturally relevant drug resistance skills, as well as decreasing girls’ aggressive behaviors, at six-month follow up. Unanticipated findings also suggested areas for curricular improvement, including more emphasis on normative drug education. Implications for future research and development of the curriculum are discussed. PMID:27180710

Core groups, antimicrobial resistance and rebound in gonorrhoea in North America.

PubMed

Chan, Christina H; McCabe, Caitlin J; Fisman, David N

2012-04-01

Genital tract infections caused by Neisseria gonorrhoeae are a major cause of sexually transmitted disease worldwide. Surveillance data suggest that incidence has increased in recent years after initially falling in the face of intensified control efforts. The authors sought to evaluate the potential contribution of antimicrobial resistance to such rebound and to identify optimal treatment strategies in the face of resistance using a mathematical model of gonorrhoea. The authors built risk-structured 'susceptible-infectious-susceptible' models with and without the possibility of antibiotic resistance and used these models as a platform for the evaluation of competing plausible treatment strategies, including changing antimicrobial choice when resistance prevalence surpassed fixed thresholds, random assignment of treatment and use of combination antimicrobial therapy. Absent antimicrobial resistance, strategies that focus on treatment of highest risk individuals (the so-called core group) result in collapse of disease transmission. When antimicrobial resistance exists, a focus on the core group causes rebound in incidence, with maximal dissemination of antibiotic resistance. Random assignment of antimicrobial treatment class outperformed the use of fixed resistance thresholds with respect to sustained reduction in gonorrhoea prevalence. Gonorrhoea control is achievable only when core groups are treated, but treatment of core groups maximises dissemination of antimicrobial-resistant strains. This paradox poses a great dilemma to the control and prevention of gonorrhoea and underlines the need for gonococcal vaccines.

A Summer Nutrition Benefit Pilot Program and Low-income Children's Food Security.

PubMed

Collins, Ann M; Klerman, Jacob A; Briefel, Ronette; Rowe, Gretchen; Gordon, Anne R; Logan, Christopher W; Wolf, Anne; Bell, Stephen H

2018-04-01

Federal summer meals programs serve less than one-sixth of children that receive free or reduced-price meals during the school year. To address this gap in food assistance for school-aged children, the Summer Electronic Benefits Transfer for Children (SEBTC) Demonstrations provided summer food assistance in the form of electronic benefits transfer cards to households with school-aged children certified for free or reduced-price meals during the school year. Over 2011-2013, the SEBTC demonstrations were evaluated by using a random assignment design. Households were randomly assigned a monthly $60-per-child benefit, a monthly $30-per-child benefit, or no benefit, depending on the study year. Key outcomes included children's food security and consumption of foods and food groups related to a healthful diet (diet quality). At baseline (in the spring) and again in the summer, the evaluation surveyed ∼52 000 households over the course of the 3 years of the impact study. SEBTC reduced the prevalence of very low food security among children by one-third. It also had positive impacts on 6 of the 8 child nutrition outcomes measured (amounts of fruits and vegetables; whole grains; dairy foods; and added sugars). SEBTC is a promising model to improve food security and the dietary quality of low-income school-aged children in the summer months. Copyright © 2018 by the American Academy of Pediatrics.

Men Respond Too: The Effects of a Social-Evaluative Body Image Threat on Shame and Cortisol in University Men

PubMed Central

Lamarche, Larkin; Ozimok, Brianne; Gammage, Kimberley L.; Muir, Cameron

2017-01-01

Framed within social self-preservation theory, the present study investigated men’s psychobiological responses to social-evaluative body image threats. University men (n = 66) were randomly assigned to either a high or low social-evaluative body image threat condition. Participants provided saliva samples (to assess cortisol) and completed measures of state body shame prior to and following their condition, during which anthropometric and strength measures were assessed. Baseline corrected values indicated men in the high social-evaluative body image threat condition had higher body shame and cortisol than men in the low social-evaluative body image threat condition. These findings suggest that social evaluation in the context of situations that threaten body image leads to potentially negative psychobiological responses in college men. PMID:28891388

Men Respond Too: The Effects of a Social-Evaluative Body Image Threat on Shame and Cortisol in University Men.

PubMed

Lamarche, Larkin; Ozimok, Brianne; Gammage, Kimberley L; Muir, Cameron

2017-11-01

Framed within social self-preservation theory, the present study investigated men's psychobiological responses to social-evaluative body image threats. University men ( n = 66) were randomly assigned to either a high or low social-evaluative body image threat condition. Participants provided saliva samples (to assess cortisol) and completed measures of state body shame prior to and following their condition, during which anthropometric and strength measures were assessed. Baseline corrected values indicated men in the high social-evaluative body image threat condition had higher body shame and cortisol than men in the low social-evaluative body image threat condition. These findings suggest that social evaluation in the context of situations that threaten body image leads to potentially negative psychobiological responses in college men.

Effect of maternal zinc supplementation on the cardiometabolic profile of Peruvian children: results from a randomized clinical trial

PubMed Central

Mispireta, ML; Caulfield, LE; Zavaleta, N; Merialdi, M; Putnick, DL; Bornstein, MH; DiPietro, JA

2018-01-01

Zinc is an essential micronutrient for the development of the fetal renal, cardiovascular, and metabolic systems; however, there is limited evidence of its effects on the postnatal cardiometabolic function. In this study, we evaluated the effect of maternal zinc supplementation during pregnancy on the cardiometabolic profile of the offspring in childhood. A total of 242 pregnant women were randomly assigned to receive a daily supplement containing iron + folic acid with or without zinc. A follow-up study was conducted when children of participating mothers were 4.5 years of age to evaluate their cardiometabolic profile, including anthropometric measures of body size and composition, blood pressure, lipid profile, and insulin resistance. No difference in measures of child cardiometabolic risk depending on whether mothers received supplemental zinc during pregnancy. Our results do not support the hypothesis that maternal zinc supplementation reduces the risk of offspring cardiometabolic disease. PMID:27748235

Outcome evaluation of a high school smoking reduction intervention based on extracurricular activities.

PubMed

Brown, K Stephen; Cameron, Roy; Madill, Cheryl; Payne, M Elizabeth; Filsinger, Stephanie; Manske, Stephen R; Best, J Allan

2002-11-01

An outcome evaluation of a high school tobacco control intervention using extracurricular activities developed by teachers and students is reported. Eligible subjects (n = 3,028) had participated in a randomized trial of an elementary school smoking prevention curriculum. Their high schools were matched in pairs; one school in each pair was randomly assigned to the intervention condition, the second to a "usual-care" control condition. Data were collected at the end of Grades 9 and 10. For Grade 8 never smokers, regular smoking rates were significantly lower for males from intervention schools (9.8 vs 16.2%, P = 0.02) at the end of Grade 10. There were no significant differences among Grade 10 smoking rates for females, or for students of either gender with previous smoking experience in Grade 8. The extracurricular activities approach to tobacco control is practical to implement and has promise.

Calcium plus vitamin D supplementation and the risk of breast cancer.

PubMed

Chlebowski, Rowan T; Johnson, Karen C; Kooperberg, Charles; Pettinger, Mary; Wactawski-Wende, Jean; Rohan, Tom; Rossouw, Jacques; Lane, Dorothy; O'Sullivan, Mary Jo; Yasmeen, Shagufta; Hiatt, Robert A; Shikany, James M; Vitolins, Mara; Khandekar, Janu; Hubbell, F Allan

2008-11-19

Although some observational studies have associated higher calcium intake and especially higher vitamin D intake and 25-hydroxyvitamin D levels with lower breast cancer risk, no randomized trial has evaluated these relationships. Postmenopausal women (N = 36 282) who were enrolled in a Women's Health Initiative clinical trial were randomly assigned to 1000 mg of elemental calcium with 400 IU of vitamin D(3) daily or placebo for a mean of 7.0 years to determine the effects of supplement use on incidence of hip fracture. Mammograms and breast exams were serially conducted. Invasive breast cancer was a secondary outcome. Baseline serum 25-hydroxyvitamin D levels were assessed in a nested case-control study of 1067 case patients and 1067 control subjects. A Cox proportional hazards model was used to estimate the risk of breast cancer associated with random assignment to calcium with vitamin D(3). Associations between 25-hydroxyvitamin D serum levels and total vitamin D intake, body mass index (BMI), recreational physical activity, and breast cancer risks were evaluated using logistic regression models. Statistical tests were two-sided. Invasive breast cancer incidence was similar in the two groups (528 supplement vs 546 placebo; hazard ratio = 0.96; 95% confidence interval = 0.85 to 1.09). In the nested case-control study, no effect of supplement group assignment on breast cancer risk was seen. Baseline 25-hydroxyvitamin D levels were modestly correlated with total vitamin D intake (diet and supplements) (r = 0.19, P < .001) and were higher among women with lower BMI and higher recreational physical activity (both P < .001). Baseline 25-hydroxyvitamin D levels were not associated with breast cancer risk in analyses that were adjusted for BMI and physical activity (P(trend) = .20). Calcium and vitamin D supplementation did not reduce invasive breast cancer incidence in postmenopausal women. In addition, 25-hydroxyvitamin D levels were not associated with subsequent breast cancer risk. These findings do not support a relationship between total vitamin D intake and 25-hydroxyvitamin D levels with breast cancer risk.

Transforming Dissatisfaction with Services into Self-Determination: A Social Psychological Perspective on Community Program Effectiveness.

PubMed

Macias, Cathaleene; Aronson, Elliot; Hargreaves, William; Weary, Gifford; Barreira, Paul J; Harvey, John; Rodican, Charles F; Bickman, Leonard; Fisher, William

2009-08-01

A field study of supported employment for adults with mental illness (N=174) provided an experimental test of cognitive dissonance theory. We predicted that most work-interested individuals randomly assigned to a non-preferred program would reject services and lower their work aspirations. However, individuals who chose to pursue employment through a non-preferred program were expected to resolve this dissonance through favorable service evaluations and strong efforts to succeed at work. Significant work interest-by-service preference interactions supported these predictions. Over two years, participants interested in employment who obtained work through a non-preferred program stayed employed a median of 362 days versus 108 days for those assigned to a preferred program, and participants who obtained work through a non-preferred program had higher service satisfaction.

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…

Do Head Start Impacts Vary by Neighborhood Context?

ERIC Educational Resources Information Center

Morris, Pamela A.; Connors, Maia C.; McCoy, Dana Charles; Gomez, Celia J.; Yoshikawa, Hiro; Aber, J. Lawrence

2014-01-01

This paper capitalizes on the addition of geocodes for Head Start centers in which children were randomly assigned to address questions about the role of neighborhood characteristics in moderating impacts of assignment to the Head Start program. Researchers explore the extent to which impacts of assignment to Head Start on outcomes for children…

Packet Randomized Experiments for Eliminating Classes of Confounders

PubMed Central

Pavela, Greg; Wiener, Howard; Fontaine, Kevin R.; Fields, David A.; Voss, Jameson D.; Allison, David B.

2014-01-01

Background Although randomization is considered essential for causal inference, it is often not possible to randomize in nutrition and obesity research. To address this, we develop a framework for an experimental design—packet randomized experiments (PREs), which improves causal inferences when randomization on a single treatment variable is not possible. This situation arises when subjects are randomly assigned to a condition (such as a new roommate) which varies in one characteristic of interest (such as weight), but also varies across many others. There has been no general discussion of this experimental design, including its strengths, limitations, and statistical properties. As such, researchers are left to develop and apply PREs on an ad hoc basis, limiting its potential to improve causal inferences among nutrition and obesity researchers. Methods We introduce PREs as an intermediary design between randomized controlled trials and observational studies. We review previous research that used the PRE design and describe its application in obesity-related research, including random roommate assignments, heterochronic parabiosis, and the quasi-random assignment of subjects to geographic areas. We then provide a statistical framework to control for potential packet-level confounders not accounted for by randomization. Results PREs have successfully been used to improve causal estimates of the effect of roommates, altitude, and breastfeeding on weight outcomes. When certain assumptions are met, PREs can asymptotically control for packet-level characteristics. This has the potential to statistically estimate the effect of a single treatment even when randomization to a single treatment did not occur. Conclusions Applying PREs to obesity-related research will improve decisions about clinical, public health, and policy actions insofar as it offers researchers new insight into cause and effect relationships among variables. PMID:25444088

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

A randomized control trial evaluating fluorescent ink versus dark ink tattoos for breast radiotherapy

PubMed Central

Kirby, Anna M; Lee, Steven F; Bartlett, Freddie; Titmarsh, Kumud; Donovan, Ellen; Griffin, Clare L; Gothard, Lone; Locke, Imogen; McNair, Helen A

2016-01-01

Objective: The purpose of this UK study was to evaluate interfraction reproducibility and body image score when using ultraviolet (UV) tattoos (not visible in ambient lighting) for external references during breast/chest wall radiotherapy and compare with conventional dark ink. Methods: In this non-blinded, single-centre, parallel group, randomized control trial, patients were allocated to receive either conventional dark ink or UV ink tattoos using computer-generated random blocks. Participant assignment was not masked. Systematic (∑) and random (σ) setup errors were determined using electronic portal images. Body image questionnaires were completed at pre-treatment, 1 month and 6 months to determine the impact of tattoo type on body image. The primary end point was to determine that UV tattoo random error (σsetup) was no less accurate than with conventional dark ink tattoos, i.e. <2.8 mm. Results: 46 patients were randomized to receive conventional dark or UV ink tattoos. 45 patients completed treatment (UV: n = 23, dark: n = 22). σsetup for the UV tattoo group was <2.8 mm in the u and v directions (p = 0.001 and p = 0.009, respectively). A larger proportion of patients reported improvement in body image score in the UV tattoo group compared with the dark ink group at 1 month [56% (13/23) vs 14% (3/22), respectively] and 6 months [52% (11/21) vs 38% (8/21), respectively]. Conclusion: UV tattoos were associated with interfraction setup reproducibility comparable with conventional dark ink. Patients reported a more favourable change in body image score up to 6 months following treatment. Advances in knowledge: This study is the first to evaluate UV tattoo external references in a randomized control trial. PMID:27710100

A randomized control trial evaluating fluorescent ink versus dark ink tattoos for breast radiotherapy.

PubMed

Landeg, Steven J; Kirby, Anna M; Lee, Steven F; Bartlett, Freddie; Titmarsh, Kumud; Donovan, Ellen; Griffin, Clare L; Gothard, Lone; Locke, Imogen; McNair, Helen A

2016-12-01

The purpose of this UK study was to evaluate interfraction reproducibility and body image score when using ultraviolet (UV) tattoos (not visible in ambient lighting) for external references during breast/chest wall radiotherapy and compare with conventional dark ink. In this non-blinded, single-centre, parallel group, randomized control trial, patients were allocated to receive either conventional dark ink or UV ink tattoos using computer-generated random blocks. Participant assignment was not masked. Systematic (∑) and random (σ) setup errors were determined using electronic portal images. Body image questionnaires were completed at pre-treatment, 1 month and 6 months to determine the impact of tattoo type on body image. The primary end point was to determine that UV tattoo random error (σ setup ) was no less accurate than with conventional dark ink tattoos, i.e. <2.8 mm. 46 patients were randomized to receive conventional dark or UV ink tattoos. 45 patients completed treatment (UV: n = 23, dark: n = 22). σ setup for the UV tattoo group was <2.8 mm in the u and v directions (p = 0.001 and p = 0.009, respectively). A larger proportion of patients reported improvement in body image score in the UV tattoo group compared with the dark ink group at 1 month [56% (13/23) vs 14% (3/22), respectively] and 6 months [52% (11/21) vs 38% (8/21), respectively]. UV tattoos were associated with interfraction setup reproducibility comparable with conventional dark ink. Patients reported a more favourable change in body image score up to 6 months following treatment. Advances in knowledge: This study is the first to evaluate UV tattoo external references in a randomized control trial.

Effect of Agaricus sylvaticus supplementation on nutritional status and adverse events of chemotherapy of breast cancer: a randomized, placebo-controlled, double-blind clinical trial.

PubMed

Valadares, Fabiana; Garbi Novaes, Maria Rita Carvalho; Cañete, Roberto

2013-01-01

Breast cancer (BC) represents the highest incidence of malignancy in women throughout the world. Medicinal fungi can stimulate the body, reduce side-effects associated with chemotherapy and improve the quality of life in patients with cancer. To evaluate the effects of dietary supplementation of Agaricus sylvaticus on clinical and nutritional parameters in BC patients undergoing chemotherapy. A randomized, placebo-controlled, double-blind, clinical trial was carried out at the Oncology Clinic, Hospital of the Federal District-Brazil from September 2007 to July 2009. Forty six patients with BC, Stage II and III, were randomly assigned to receive either nutritional supplement with A. sylvaticus (2.1 g/day) or placebo. Patients were evaluated during treatment period. Patient supplemented with A. sylvaticus improved in clinical parameters and gastrointestinal functions. Poor appetite decreased by 20% with no changes in bowel functions (92.8%), nausea and vomiting (80%). Dietary supplementation with A. sylvaticus improved nutritional status and reduced abnormal bowel functions, nausea, vomiting, and anorexia in patients with BC receiving chemotherapy.

Clinical and electrophysiologic results after intracameral lidocaine 1% anesthesia: a prospective randomized study.

PubMed

Anders, N; Heuermann, T; Rüther, K; Hartmann, C

1999-10-01

To evaluate the efficacy and safety of intracameral lidocaine in cataract surgery compared to peribulbar anesthesia. A prospective, randomized, controlled study. A total of 200 consecutive cataract patients (200 eyes) participated. Eyes were randomly assigned to two groups: one group received 0.15 ml intracameral 1% unpreserved lidocaine combined with topical anesthesia (oxybuprocaine); the other group received 6 ml prilocaine peribulbar before phacoemulsification with sclerocorneal tunnel incision. Duration of surgery was measured; implicit time and amplitudes of the b-waves of the photopic electroretinogram (ERG) potentials (single-flash ERG and the 30-Hz flicker ERG) were recorded; frequencies of intraoperative problems, complications, intraoperative, and postoperative pain were evaluated. After lidocaine anesthesia combined with topical anesthesia, similar complications were found, longer operation time (P < 0.001), and significantly better visual acuity immediately after surgery (P < 0.001). The ERG amplitudes were not significantly reduced after 0.15-ml intracameral lidocaine half an hour after surgery (P > 0.05). Intracameral lidocaine 1% combined with topical anesthesia can be recommended as an alternative procedure to peribulbar anesthesia in cataract surgery with corneoscleral tunnel incision.

Evaluating the Impact of Feedback on Elementary Aged Students’ Fluency Growth in Written Expression: A Randomized Controlled Trial

PubMed Central

Truckenmiller, Adrea J.; Eckert, Tanya L.; Codding, Robin S.; Petscher, Yaacov

2016-01-01

The purpose of this randomized controlled trial was to evaluate elementary-aged students’ writing fluency growth in response to (a) instructional practices, (b) sex differences, and (c) student’s initial level of writing fluency. Third-grade students (n=133) in three urban elementary schools were randomly assigned to either an individualized performance feedback condition (n=46), a practice-only condition (i.e., weekly writing practice; n = 39), or an instructional control condition (n = 48) for 8 weeks. Findings included support for use of performance feedback as an instructional component in general education classrooms (Hedges’ g = 0.66), whereas simple practice with curriculum-based measurement in written expression did not produce growth significantly greater than standard instructional practices. The hypothesis that girls write significantly more than boys was supported. However, girls and boys did not differ in their rate of growth. Finally, students’ initial risk status in writing fluency did not differentially predict growth in writing fluency over the course of the study. Implications for incorporating feedback as a basic component of intervention in writing are discussed. PMID:25432270

Evaluating hospital discharge planning: a randomized clinical trial.

PubMed

Evans, R L; Hendricks, R D

1993-04-01

To select patients for early discharge planning, a randomized clinical trial evaluated a protocol that used risk factors identified upon hospital admission. The goal of the study was to determine if intervention with high-risk patients could reduce the need for hospital admission or skilled care. Of 13,255 patients screened, 835 study participants were identified as "at risk" for frequent health care resource use. Half of the high-risk patients were randomly assigned to the experimental group (n = 417) and received discharge planning from day 3 of their hospital stay, while the control group (n = 418) received discharge planning only if there was a written physician request. Those patients receiving early, systematic discharge planning experienced an increased likelihood of successful return to home after hospital admission and a decreased chance of unscheduled readmission for the 9-month study period. Length of the index hospital stay was not affected by early planning, however. The major clinical implication is the potential for discharge planners to decrease the need for, and use of, health care resources after hospital admission.

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

PubMed

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

2015-07-01

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

Evaluating Personalized Feedback Intervention Framing with a Randomized Controlled Trial to Reduce Young Adult Alcohol-Related Sexual Risk Taking.

PubMed

Lewis, Melissa A; Rhew, Isaac C; Fairlie, Anne M; Swanson, Alex; Anderson, Judyth; Kaysen, Debra

2018-03-06

The purpose of this study was to evaluate personalized feedback intervention (PFI) framing with two web-delivered PFIs aimed to reduce young adult alcohol-related risky sexual behavior (RSB). Combined PFIs typically use an additive approach whereby independent components on drinking and components on RSB are presented without the discussion of the influence of alcohol on RSB. In contrast, an integrated PFI highlights the RSB-alcohol connection by presenting integrated alcohol and RSB components that focus on the role of intoxication as a barrier to risk reduction in sexual situations. In a randomized controlled trial, 402 (53.98% female) sexually active young adults aged 18-25 were randomly assigned to a combined PFI, an integrated PFI, or attention control. All assessment and intervention procedures were web-based. At the 1-month follow-up, those randomly assigned to the integrated condition had a lower likelihood of having any casual sex partners compared to those in the control group. At the 6-month follow-up, the combined condition had a lower likelihood of having any casual sex partners compared to those in the control group. When examining alcohol-related RSB, at the 1-month follow-up, both interventions showed a lower likelihood of any drinking prior to sex compared to the control group. When examining alcohol-related sexual consequences, results showed a reduction in the non-zero count of consequences in the integrated condition compared to the control at the 1-month follow-up. For typical drinks per week, those in the combined condition showed a greater reduction in the non-zero count of drinks than those in the control condition at the 1-month follow-up. While there were no significant differences between the two interventions, the current findings highlight the utility of two efficacious web-based alcohol and RSB interventions among a national sample of at-risk young adults.

A randomized clinical trial evaluating gingivitis and plaque reduction of an oscillating-rotating power brush with a new brush head with angled bristles versus a marketed sonic brush with self-adjusting technology.

PubMed

Klukowska, Malgorzata; Grender, Julie M; Conde, Erinn; Ccahuana-Vasquez, Renzo Alberto; Ram Goyal, C

2014-08-01

To compare the efficacy of an oscillating-rotating power toothbrush with a novel brush head incorporating angled CrissCross bristles (Oral-B Pro 7000 SmartSeries and Oral-B CrossAction brush head) versus a marketed sonic toothbrush (Colgate ProClinical A1500 with the Triple Clean brush head) in the reduction of gingivitis and plaque over a 6-week period. This was a single center, randomized, open label, examiner-blind, 2-treatment, parallel group study. Study participants who met the entrance criteria were enrolled in the study and randomly assigned to one of the two toothbrush groups. Study participants brushed with their assigned toothbrush and a marketed fluoride dentifrice for 2 minutes twice daily at home for 6 weeks. Gingivitis and plaque were evaluated at baseline and Week 6. Gingivitis was assessed using the Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI) and plaque was assessed using the Rustogi Modified Navy Plaque Index (RMNPI). Data was analyzed using the ANCOVA with baseline as the covariate. In total, 130 study participants were randomized to treatment resulting in 64 study participants per group completing the study. Both brushes produced statistically significant (P < 0.001) reductions in gingivitis and plaque measures relative to baseline. The oscillating-rotating,brush with the novel brush head demonstrated statistically significantly (P < 0.05) greater reductions in all gingivitis measures, as well as whole mouth and interproximal plaque measures, compared to the sonic toothbrush. The benefit for the oscillating- rotating brush over the sonic brush was 21.3% for gingivitis, 35.7% for gingival bleeding, 34.7% for number of bleeding sites, 17.4% for whole mouth plaque, and 21.2% for interproximal plaque. There were no adverse events reported or observed for either brush.

Tai Chi Chih Compared With Cognitive Behavioral Therapy for the Treatment of Insomnia in Survivors of Breast Cancer: A Randomized, Partially Blinded, Noninferiority Trial

PubMed Central

Olmstead, Richard; Carrillo, Carmen; Sadeghi, Nina; Nicassio, Perry; Ganz, Patricia A.; Bower, Julienne E.

2017-01-01

Purpose Cognitive behavioral therapy for insomnia (CBT-I) and Tai Chi Chih (TCC), a movement meditation, improve insomnia symptoms. Here, we evaluated whether TCC is noninferior to CBT-I for the treatment of insomnia in survivors of breast cancer. Patients and Methods This was a randomized, partially blinded, noninferiority trial that involved survivors of breast cancer with insomnia who were recruited from the Los Angeles community from April 2008 to July 2012. After a 2-month phase-in period with repeated baseline assessment, participants were randomly assigned to 3 months of CBT-I or TCC and evaluated at months 2, 3 (post-treatment), 6, and 15 (follow-up). Primary outcome was insomnia treatment response—that is, marked clinical improvement of symptoms by the Pittsburgh Sleep Quality Index—at 15 months. Secondary outcomes were clinician-assessed remission of insomnia; sleep quality; total sleep time, sleep onset latency, sleep efficiency, and awake after sleep onset, derived from sleep diaries; polysomnography; and symptoms of fatigue, sleepiness, and depression. Results Of 145 participants who were screened, 90 were randomly assigned (CBT-I: n = 45; TCC: n = 45). The proportion of participants who showed insomnia treatment response at 15 months was 43.7% and 46.7% in CBT-I and TCC, respectively. Tests of noninferiority showed that TCC was noninferior to CBT-I at 15 months (P = .02) and at months 3 (P = .02) and 6 (P < .01). For secondary outcomes, insomnia remission was 46.2% and 37.9% in CBT-I and TCC, respectively. CBT-I and TCC groups showed robust improvements in sleep quality, sleep diary measures, and related symptoms (all P < .01), but not polysomnography, with similar improvements in both groups. Conclusion CBT-I and TCC produce clinically meaningful improvements in insomnia. TCC, a mindful movement meditation, was found to be statistically noninferior to CBT-I, the gold standard for behavioral treatment of insomnia. PMID:28489508

Randomized Phase II, Double-Blind, Placebo-Controlled Study of Exemestane With or Without Entinostat in Postmenopausal Women With Locally Recurrent or Metastatic Estrogen Receptor-Positive Breast Cancer Progressing on Treatment With a Nonsteroidal Aromatase Inhibitor

PubMed Central

Yardley, Denise A.; Ismail-Khan, Roohi R.; Melichar, Bohuslav; Lichinitser, Mikhail; Munster, Pamela N.; Klein, Pamela M.; Cruickshank, Scott; Miller, Kathy D.; Lee, Min J.; Trepel, Jane B

2013-01-01

Purpose Entinostat is an oral isoform selective histone deacetylase inhibitor that targets resistance to hormonal therapies in estrogen receptor–positive (ER+) breast cancer. This randomized, placebo-controlled, phase II study evaluated entinostat combined with the aromatase inhibitor exemestane versus exemestane alone. Patients and Methods Postmenopausal women with ER+ advanced breast cancer progressing on a nonsteroidal aromatase inhibitor were randomly assigned to exemestane 25 mg daily plus entinostat 5 mg once per week (EE) or exemestane plus placebo (EP). The primary end point was progression-free survival (PFS). Blood was collected in a subset of patients for evaluation of protein lysine acetylation as a biomarker of entinostat activity. Results One hundred thirty patients were randomly assigned (EE group, n = 64; EP group, n = 66). Based on intent-to-treat analysis, treatment with EE improved median PFS to 4.3 months versus 2.3 months with EP (hazard ratio [HR], 0.73; 95% CI, 0.50 to 1.07; one-sided P = .055; two-sided P = .11 [predefined significance level of .10, one-sided]). Median overall survival was an exploratory end point and improved to 28.1 months with EE versus 19.8 months with EP (HR, 0.59; 95% CI, 0.36 to 0.97; P = .036). Fatigue and neutropenia were the most frequent grade 3/4 toxicities. Treatment discontinuation because of adverse events was higher in the EE group versus the EP group (11% v 2%). Protein lysine hyperacetylation in the EE biomarker subset was associated with prolonged PFS. Conclusion Entinostat added to exemestane is generally well tolerated and demonstrated activity in patients with ER+ advanced breast cancer in this signal-finding phase II study. Acetylation changes may provide an opportunity to maximize clinical benefit with entinostat. Plans for a confirmatory study are underway. PMID:23650416

Learning to Dislike Chocolate: Conditioning Negative Attitudes toward Chocolate and Its Effect on Chocolate Consumption.

PubMed

Wang, Yan; Wang, Guosen; Zhang, Dingyuan; Wang, Lei; Cui, Xianghua; Zhu, Jinglei; Fang, Yuan

2017-01-01

Evaluative conditioning (EC) procedures can be used to form and change attitudes toward a wide variety of objects. The current study examined the effects of a negative EC procedure on attitudes toward chocolate, and whether it influenced chocolate evaluation and consumption. Participants were randomly assigned to the experimental condition in which chocolate images were paired with negative stimuli, or the control condition in which chocolate images were randomly paired with positive stimuli (50%) and negative stimuli (50%). Explicit and implicit attitudes toward chocolate images were collected. During an ostensible taste test, chocolate evaluation and consumption were assessed. Results revealed that compared to participants in the control condition, participants in the experimental condition showed more negative explicit and implicit attitudes toward chocolate images and evaluated chocolate more negatively during the taste test. However, chocolate consumption did not differ between experimental and control conditions. These findings suggest that pairing chocolate with negative stimuli can influence attitudes toward chocolate, though behavioral effects are absent. Intervention applications of EC provide avenues for future research and practices.

Learning to Dislike Chocolate: Conditioning Negative Attitudes toward Chocolate and Its Effect on Chocolate Consumption

PubMed Central

Wang, Yan; Wang, Guosen; Zhang, Dingyuan; Wang, Lei; Cui, Xianghua; Zhu, Jinglei; Fang, Yuan

2017-01-01

Evaluative conditioning (EC) procedures can be used to form and change attitudes toward a wide variety of objects. The current study examined the effects of a negative EC procedure on attitudes toward chocolate, and whether it influenced chocolate evaluation and consumption. Participants were randomly assigned to the experimental condition in which chocolate images were paired with negative stimuli, or the control condition in which chocolate images were randomly paired with positive stimuli (50%) and negative stimuli (50%). Explicit and implicit attitudes toward chocolate images were collected. During an ostensible taste test, chocolate evaluation and consumption were assessed. Results revealed that compared to participants in the control condition, participants in the experimental condition showed more negative explicit and implicit attitudes toward chocolate images and evaluated chocolate more negatively during the taste test. However, chocolate consumption did not differ between experimental and control conditions. These findings suggest that pairing chocolate with negative stimuli can influence attitudes toward chocolate, though behavioral effects are absent. Intervention applications of EC provide avenues for future research and practices. PMID:28900409

Overview of registered studies in orthodontics: Evaluation of the ClinicalTrials.gov registry.

PubMed

Allareddy, Veerasathpurush; Rampa, Sankeerth; Masoud, Mohamed I; Lee, Min Kyeong; Nalliah, Romesh; Allareddy, Veerajalandhar

2014-11-01

The Food and Drug Administration Modernization Act of 1997 made it mandatory for all phase II through IV trials regulated by this Act to be registered. After this, the National Institutes of Health created ClinicalTrials.gov, which is a registry of publicly and privately supported clinical studies of human participants. The objective of this study was to examine the characteristics of registered studies in orthodontics. The ClinicalTrials.gov Web site was used to query all registered orthodontic studies. The search term used was "orthodontics." No limitations were placed for the time period. All registered studies regardless of their recruitment status, study results, and study type were selected for analysis. A total of 64 orthodontic studies were registered as of January 1, 2014. Of these, 52 were interventional, and 12 were observational. Close to 60% of the interventional studies and 66.7% of the observational studies had sample sizes of 50 or fewer subjects. About 21.2% of the interventional studies and 16.7% of the observational studies had sample sizes greater than 100. Only 1 study was funded by the National Institutes of Health, and the rest were funded by "other" or "industry" sources. Close to 87.7% of the interventional studies were randomized. Interventional model assignments included factorial assignment (3.9%), parallel assignments (74.5%), crossover assignment (7.8%), and single-group assignment (13.7%). Most studies were treatment oriented (80.4%). The types of masking used by the interventional studies included open label (28.9%), single blind (44.2%), and double blind (26.9%). Outcome assessors were blinded in only 6 studies. Orthodontic studies registered in ClinicalTrials.gov are dominated by small single-center studies. There are wide variations with regard to treatment allocation approaches and randomization methods in the studies. These results also indicate the need for multicenter clinical studies in orthodontics. Copyright © 2014 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

Intra-articular corticosteroids versus intra-articular corticosteroids plus methotrexate in oligoarticular juvenile idiopathic arthritis: a multicentre, prospective, randomised, open-label trial.

PubMed

Ravelli, Angelo; Davì, Sergio; Bracciolini, Giulia; Pistorio, Angela; Consolaro, Alessandro; van Dijkhuizen, Evert Hendrik Pieter; Lattanzi, Bianca; Filocamo, Giovanni; Verazza, Sara; Gerloni, Valeria; Gattinara, Maurizio; Pontikaki, Irene; Insalaco, Antonella; De Benedetti, Fabrizio; Civino, Adele; Presta, Giuseppe; Breda, Luciana; Marzetti, Valentina; Pastore, Serena; Magni-Manzoni, Silvia; Maggio, Maria Cristina; Garofalo, Franco; Rigante, Donato; Gattorno, Marco; Malattia, Clara; Picco, Paolo; Viola, Stefania; Lanni, Stefano; Ruperto, Nicolino; Martini, Alberto

2017-03-04

Little evidence-based information is available to guide the treatment of oligoarticular juvenile idiopathic arthritis. We aimed to investigate whether oral methotrexate increases the efficacy of intra-articular corticosteroid therapy. We did this prospective, open-label, randomised trial at ten hospitals in Italy. Using a concealed computer-generated list, children younger than 18 years with oligoarticular-onset disease were randomly assigned (1:1) to intra-articular corticosteroids alone or in combination with oral methotrexate (15 mg/m 2 ; maximum 20 mg). Corticosteroids used were triamcinolone hexacetonide (shoulder, elbow, wrist, knee, and tibiotalar joints) or methylprednisolone acetate (ie, subtalar and tarsal joints). We did not mask patients or investigators to treatment assignments. Our primary outcome was the proportion of patients in the intention-to-treat population who had remission of arthritis in all injected joints at 12 months. This trial is registered with European Union Clinical Trials Register, EudraCT number 2008-006741-70. Between July 7, 2009, and March 31, 2013, we screened 226 participants and randomly assigned 102 to intra-articular corticosteroids alone and 105 to intra-articular corticosteroids plus methotrexate. 33 (32%) patients assigned to intra-articular corticosteroids alone and 39 (37%) assigned to intra-articular corticosteroids and methotrexate therapy had remission of arthritis in all injected joints (p=0·48). Adverse events were recorded for 20 (17%) patients who received methotrexate, which led to permanent treatment discontinuation in two patients (one due to increased liver transaminases and one due to gastrointestinal discomfort). No patient had a serious adverse event. Concomitant administration of methotrexate did not augment the effectiveness of intra-articular corticosteroid therapy. Future studies are needed to define the optimal therapeutic strategies for oligoarticular juvenile idiopathic arthritis. Italian Agency of Drug Evaluation. Copyright © 2017 Elsevier Ltd. All rights reserved.

Analysis of saccular aneurysms in the Barrow Ruptured Aneurysm Trial.

PubMed

Spetzler, Robert F; Zabramski, Joseph M; McDougall, Cameron G; Albuquerque, Felipe C; Hills, Nancy K; Wallace, Robert C; Nakaji, Peter

2018-01-01

OBJECTIVE The Barrow Ruptured Aneurysm Trial (BRAT) is a prospective, randomized trial in which treatment with clipping was compared to treatment with coil embolization. Patients were randomized to treatment on presentation with any nontraumatic subarachnoid hemorrhage (SAH). Because all other randomized trials comparing these 2 types of treatments have been limited to saccular aneurysms, the authors analyzed the current BRAT data for this subgroup of lesions. METHODS The primary BRAT analysis included all sources of SAH: nonaneurysmal lesions; saccular, blister, fusiform, and dissecting aneurysms; and SAHs from an aneurysm associated with either an arteriovenous malformation or a fistula. In this post hoc review, the outcomes for the subgroup of patients with saccular aneurysms were further analyzed by type of treatment. The extent of aneurysm obliteration was adjudicated by an independent neuroradiologist not involved in treatment. RESULTS Of the 471 patients enrolled in the BRAT, 362 (77%) had an SAH from a saccular aneurysm. Patients with saccular aneurysms were assigned equally to the clipping and the coiling cohorts (181 each). In each cohort, 3 patients died before treatment and 178 were treated. Of the 178 clip-assigned patients with saccular aneurysms, 1 (1%) was crossed over to coiling, and 64 (36%) of the 178 coil-assigned patients were crossed over to clipping. There was no statistically significant difference in poor outcome (modified Rankin Scale score > 2) between these 2 treatment arms at any recorded time point during 6 years of follow-up. After the initial hospitalization, 1 of 241 (0.4%) clipped saccular aneurysms and 21 of 115 (18%) coiled saccular aneurysms required retreatment (p < 0.001). At the 6-year follow-up, 95% (95/100) of the clipped aneurysms were completely obliterated, compared with 40% (16/40) of the coiled aneurysms (p < 0.001). There was no difference in morbidity between the 2 treatment groups (p = 0.10). CONCLUSIONS In the subgroup of patients with saccular aneurysms enrolled in the BRAT, there was no significant difference between modified Rankin Scale outcomes at any follow-up time in patients with saccular aneurysms assigned to clipping compared with those assigned to coiling (intent-to-treat analysis). At the 6-year follow-up evaluation, rates of retreatment and complete aneurysm obliteration significantly favored patients who underwent clipping compared with those who underwent coiling. Clinical trial registration no.: NCT01593267 (clinicaltrials.gov).

Levosimendan in Patients with Left Ventricular Dysfunction Undergoing Cardiac Surgery.

PubMed

Mehta, Rajendra H; Leimberger, Jeffrey D; van Diepen, Sean; Meza, James; Wang, Alice; Jankowich, Rachael; Harrison, Robert W; Hay, Douglas; Fremes, Stephen; Duncan, Andra; Soltesz, Edward G; Luber, John; Park, Soon; Argenziano, Michael; Murphy, Edward; Marcel, Randy; Kalavrouziotis, Dimitri; Nagpal, Dave; Bozinovski, John; Toller, Wolfgang; Heringlake, Matthias; Goodman, Shaun G; Levy, Jerrold H; Harrington, Robert A; Anstrom, Kevin J; Alexander, John H

2017-05-25

Levosimendan is an inotropic agent that has been shown in small studies to prevent or treat the low cardiac output syndrome after cardiac surgery. In a multicenter, randomized, placebo-controlled, phase 3 trial, we evaluated the efficacy and safety of levosimendan in patients with a left ventricular ejection fraction of 35% or less who were undergoing cardiac surgery with the use of cardiopulmonary bypass. Patients were randomly assigned to receive either intravenous levosimendan (at a dose of 0.2 μg per kilogram of body weight per minute for 1 hour, followed by a dose of 0.1 μg per kilogram per minute for 23 hours) or placebo, with the infusion started before surgery. The two primary end points were a four-component composite of death through day 30, renal-replacement therapy through day 30, perioperative myocardial infarction through day 5, or use of a mechanical cardiac assist device through day 5; and a two-component composite of death through day 30 or use of a mechanical cardiac assist device through day 5. A total of 882 patients underwent randomization, 849 of whom received levosimendan or placebo and were included in the modified intention-to-treat population. The four-component primary end point occurred in 105 of 428 patients (24.5%) assigned to receive levosimendan and in 103 of 421 (24.5%) assigned to receive placebo (adjusted odds ratio, 1.00; 99% confidence interval [CI], 0.66 to 1.54; P=0.98). The two-component primary end point occurred in 56 patients (13.1%) assigned to receive levosimendan and in 48 (11.4%) assigned to receive placebo (adjusted odds ratio, 1.18; 96% CI, 0.76 to 1.82; P=0.45). The rate of adverse events did not differ significantly between the two groups. Prophylactic levosimendan did not result in a rate of the short-term composite end point of death, renal-replacement therapy, perioperative myocardial infarction, or use of a mechanical cardiac assist device that was lower than the rate with placebo among patients with a reduced left ventricular ejection fraction who were undergoing cardiac surgery with the use of cardiopulmonary bypass. (Funded by Tenax Therapeutics; LEVO-CTS ClinicalTrials.gov number, NCT02025621 .).

Paliperidone palmitate once-monthly maintains improvement in functioning domains of the Personal and Social Performance scale compared with placebo in subjects with schizoaffective disorder.

PubMed

Fu, Dong-Jing; Turkoz, Ibrahim; Walling, David; Lindenmayer, Jean-Pierre; Schooler, Nina R; Alphs, Larry

2018-02-01

Evaluate the effect of paliperidone palmitate once-monthly (PP1M) injectable on the specific functioning domains of the Personal and Social Performance (PSP) scale in patients with schizoaffective disorder (SCA) participating in a long-term study. This study (NCT01193153) included both in- and outpatient subjects with SCA experiencing an acute exacerbation of psychotic and mood symptoms. Subjects were treated with PP1M either as monotherapy or in combination with antidepressants or mood stabilizers during a 25-week open-label (OL) phase. Stabilized subjects were randomly assigned 1:1 (PP1M or placebo) into a 15-month double-blind (DB) relapse-prevention period. Functioning of the randomized subjects during OL and DB phases was evaluated using the PSP scale (four domains: socially useful activities, personal/social relationships, self-care, and disturbing/aggressive behaviors). Three statistical approaches were utilized to analyze PSP scores to assess robustness and consistency of findings. No adjustments were made for multiplicity. 334 of 667 enrolled subjects were stabilized with PP1M, randomly assigned to PP1M (n=164) or placebo (n=170) in the DB phase, and included in this analysis. Improvements in all PSP domain scores were observed during the OL phase and were maintained during the DB phase with PP1M, but decreased with placebo. Differences compared to placebo were significant in all four PSP domains during the DB phase (P≤0.008). The analysis in this study showed that PP1M improves functioning, as measured by the four PSP domain scores, in symptomatic subjects with SCA. Functioning was maintained compared with placebo. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.