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…

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.

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)…

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

ERIC Educational Resources Information Center

What Works Clearinghouse, 2012

2012-01-01

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

The 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

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…

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.

Peer Influence, Genetic Propensity, and Binge Drinking: A Natural Experiment and a Replication.

PubMed

Guo, Guang; Li, Yi; Wang, Hongyu; Cai, Tianji; Duncan, Greg J

2015-11-01

The authors draw data from the College Roommate Study (ROOM) and the National Longitudinal Study of Adolescent Health to investigate gene-environment interaction effects on youth binge drinking. In ROOM, the environmental influence was measured by the precollege drinking behavior of randomly assigned roommates. Random assignment safeguards against friend selection and removes the threat of gene-environment correlation that makes gene-environment interaction effects difficult to interpret. On average, being randomly assigned a drinking peer as opposed to a nondrinking peer increased college binge drinking by 0.5-1.0 episodes per month, or 20%-40% the average amount of binge drinking. However, this peer influence was found only among youths with a medium level of genetic propensity for alcohol use; those with either a low or high genetic propensity were not influenced by peer drinking. A replication of the findings is provided in data drawn from Add Health. The study shows that gene-environment interaction analysis can uncover social-contextual effects likely to be missed by traditional sociological approaches.

Testosterone Combined with Electrical Stimulation and Standing: Effect on Muscle and Bone

DTIC Science & Technology

2017-10-01

determined by the site physician and site PI. Research participants will be randomized into one of four groups : 1) Stand Training only; 2) Stand...Evaluate and assign participants to one of the four randomized groups at Kessler Ongoing Milestone Achieved: Kessler and JJPVAMC sites: Study...begins 4-6 Continue subject recruitment 4-30 Continue Screen potential participants 4-30 Evaluate and assign participants to one of the four

Primary Prevention of Cardiovascular Disease with a Mediterranean Diet Supplemented with Extra-Virgin Olive Oil or Nuts.

PubMed

Estruch, Ramón; Ros, Emilio; Salas-Salvadó, Jordi; Covas, Maria-Isabel; Corella, Dolores; Arós, Fernando; Gómez-Gracia, Enrique; Ruiz-Gutiérrez, Valentina; Fiol, Miquel; Lapetra, José; Lamuela-Raventos, Rosa M; Serra-Majem, Lluís; Pintó, Xavier; Basora, Josep; Muñoz, Miguel A; Sorlí, José V; Martínez, J Alfredo; Fitó, Montserrat; Gea, Alfredo; Hernán, Miguel A; Martínez-González, Miguel A

2018-06-21

Observational cohort studies and a secondary prevention trial have shown inverse associations between adherence to the Mediterranean diet and cardiovascular risk. In a multicenter trial in Spain, we assigned 7447 participants (55 to 80 years of age, 57% women) who were at high cardiovascular risk, but with no cardiovascular disease at enrollment, to one of three diets: a Mediterranean diet supplemented with extra-virgin olive oil, a Mediterranean diet supplemented with mixed nuts, or a control diet (advice to reduce dietary fat). Participants received quarterly educational sessions and, depending on group assignment, free provision of extra-virgin olive oil, mixed nuts, or small nonfood gifts. The primary end point was a major cardiovascular event (myocardial infarction, stroke, or death from cardiovascular causes). After a median follow-up of 4.8 years, the trial was stopped on the basis of a prespecified interim analysis. In 2013, we reported the results for the primary end point in the Journal. We subsequently identified protocol deviations, including enrollment of household members without randomization, assignment to a study group without randomization of some participants at 1 of 11 study sites, and apparent inconsistent use of randomization tables at another site. We have withdrawn our previously published report and now report revised effect estimates based on analyses that do not rely exclusively on the assumption that all the participants were randomly assigned. A primary end-point event occurred in 288 participants; there were 96 events in the group assigned to a Mediterranean diet with extra-virgin olive oil (3.8%), 83 in the group assigned to a Mediterranean diet with nuts (3.4%), and 109 in the control group (4.4%). In the intention-to-treat analysis including all the participants and adjusting for baseline characteristics and propensity scores, the hazard ratio was 0.69 (95% confidence interval [CI], 0.53 to 0.91) for a Mediterranean diet with extra-virgin olive oil and 0.72 (95% CI, 0.54 to 0.95) for a Mediterranean diet with nuts, as compared with the control diet. Results were similar after the omission of 1588 participants whose study-group assignments were known or suspected to have departed from the protocol. In this study involving persons at high cardiovascular risk, the incidence of major cardiovascular events was lower among those assigned to a Mediterranean diet supplemented with extra-virgin olive oil or nuts than among those assigned to a reduced-fat diet. (Funded by Instituto de Salud Carlos III, Spanish Ministry of Health, and others; Current Controlled Trials number, ISRCTN35739639 .).

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.

Treatment assignment guesses by study participants in a double-blind dose escalation clinical trial of saw palmetto.

PubMed

Lee, Jeannette Y; Moore, Page; Kusek, John; Barry, Michael

2014-01-01

This report assesses participant perception of treatment assignment in a randomized, double-blind, placebo-controlled trial of saw palmetto for the treatment of benign prostatic hyperplasia (BCM). Participants randomized to receive saw palmetto were instructed to take one 320 mg gelcap daily for the first 24 weeks, two 320 mg gelcaps daily for the second 24 weeks, and three 320 mg gelcaps daily for the third 24 weeks. Study participants assigned to placebo were instructed to take the same number of matching placebo gelcaps in each time period. At 24, 48, and 72 weeks postrandomization, the American Urological Association Symptom Index (AUA-SI) was administered and participants were asked to guess their treatment assignment. The study was conducted at 11 clinical centers in North America. Study participants were men, 45 years and older, with moderate to low severe BPH symptoms, randomized to saw palmetto (N=151) or placebo (N=155). Treatment arms were compared with respect to the distribution of participant guesses of treatment assignment. For participants assigned to saw palmetto, 22.5%, 24.7%, and 29.8% correctly thought they were taking saw palmetto, and 37.3%, 40.0%, and 44.4% incorrectly thought they were on placebo at 24, 48, and 72 weeks, respectively. For placebo participants, 21.8%, 27.4%, and 25.2% incorrectly thought they were on saw palmetto, and 41.6%, 39.9%, and 42.6% correctly thought they were on placebo at 24, 48, and 72 weeks, respectively. The treatment arms did not vary with respect to the distributions of participants who guessed they were on saw palmetto (p=0.823) or placebo (p=0.893). Participants who experienced an improvement in AUA-SI were 2.16 times more likely to think they were on saw palmetto. Blinding of treatment assignment was successful in this study. Improvement in BPH-related symptoms was associated with the perception that participants were taking saw palmetto.

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.

Estimating the optimal dynamic antipsychotic treatment regime: Evidence from the sequential multiple assignment randomized CATIE Schizophrenia Study

PubMed Central

Shortreed, Susan M.; Moodie, Erica E. M.

2012-01-01

Summary Treatment of schizophrenia is notoriously difficult and typically requires personalized adaption of treatment due to lack of efficacy of treatment, poor adherence, or intolerable side effects. The Clinical Antipsychotic Trials in Intervention Effectiveness (CATIE) Schizophrenia Study is a sequential multiple assignment randomized trial comparing the typical antipsychotic medication, perphenazine, to several newer atypical antipsychotics. This paper describes the marginal structural modeling method for estimating optimal dynamic treatment regimes and applies the approach to the CATIE Schizophrenia Study. Missing data and valid estimation of confidence intervals are also addressed. PMID:23087488

Improved outcome in pediatric relapsed acute myeloid leukemia: results of a randomized trial on liposomal daunorubicin by the International BFM Study Group.

PubMed

Kaspers, Gertjan J L; Zimmermann, Martin; Reinhardt, Dirk; Gibson, Brenda E S; Tamminga, Rienk Y J; Aleinikova, Olga; Armendariz, Hortensia; Dworzak, Michael; Ha, Shau-Yin; Hasle, Henrik; Hovi, Liisa; Maschan, Alexei; Bertrand, Yves; Leverger, Guy G; Razzouk, Bassem I; Rizzari, Carmelo; Smisek, Petr; Smith, Owen; Stark, Batia; Creutzig, Ursula

2013-02-10

In pediatric relapsed acute myeloid leukemia (AML), optimal reinduction therapy is unknown. Studies suggest that liposomal daunorubicin (DNX; DaunoXome; Galen, Craigavon, United Kingdom) is effective and less cardiotoxic, which is important in this setting. These considerations led to a randomized phase III study by the International Berlin-Frankfurt-Münster Study Group. Patients with relapsed or primary refractory non-French-American-British type M3 AML who were younger than 21 years of age were eligible. Patients were randomly assigned to fludarabine, cytarabine, and granulocyte colony-stimulating factor (FLAG) or to FLAG plus DNX in the first reinduction course. The primary end point was status of the bone marrow (BM) sampled shortly before the second course of chemotherapy (the day 28 BM). Data are presented according to intention-to-treat for all 394 randomly assigned patients (median follow-up, 4.0 years). The complete remission (CR) rate was 64%, and the 4-year probability of survival (pOS) was 38% (SE, 3%). The day 28 BM status (available in 359 patients) was good (≤ 20% leukemic blasts) in 80% of patients randomly assigned to FLAG/DNX and 70% for patients randomly assigned to FLAG (P = .04). Concerning secondary end points, the CR rate was 69% with FLAG/DNX and 59% with FLAG (P = .07), but overall survival was similar. However, core-binding factor (CBF) AML treated with FLAG/DNX resulted in pOS of 82% versus 58% with FLAG (P = .04). Grade 3 to 4 toxicity was essentially similar in both groups. DNX added to FLAG improves early treatment response in pediatric relapsed AML. Overall long-term survival was similar, but CBF-AML showed an improved survival with FLAG/DNX. International collaboration proved feasible and resulted in the best outcome for pediatric relapsed AML reported thus far.

Testing a Violence-Prevention Intervention for Incarcerated Women Using a Randomized Control Trial

ERIC Educational Resources Information Center

Kubiak, Sheryl Pimlott; Kim, Woo Jong; Fedock, Gina; Bybee, Deborah

2015-01-01

Objective: Beyond Violence (BV), a new prevention program for women with assaultive offenses, demonstrated feasibility in previous studies. This study's purpose is to assess the efficacy of BV using a randomized control trial. Method: Eligible women were randomly assigned to treatment as usual (TAU) and the experimental condition (BV). Measures of…

A Randomized Controlled Study of the Virginia Student Threat Assessment Guidelines in Kindergarten through Grade 12

ERIC Educational Resources Information Center

Cornell, Dewey G.; Allen, Korrie; Fan, Xitao

2012-01-01

This randomized controlled study examined disciplinary outcomes for 201 students who made threats of violence at school. The students attended 40 schools randomly assigned to use the Virginia Student Threat Assessment Guidelines or follow a business-as-usual disciplinary approach in a control group. Logistic regression analyses found, after…

The Effects of Team-Based Learning on Social Studies Knowledge Acquisition in High School

ERIC Educational Resources Information Center

Wanzek, Jeanne; Vaughn, Sharon; Kent, Shawn C.; Swanson, Elizabeth A.; Roberts, Greg; Haynes, Martha; Fall, Anna-Mária; Stillman-Spisak, Stephanie J.; Solis, Michael

2014-01-01

This randomized control trial examined the efficacy of team-based learning implemented within 11th-grade social studies classes. A randomized blocked design was implemented with 26 classes randomly assigned to treatment or comparison. In the treatment classes teachers implemented team-based learning practices to support students in engaging in…

Evaluating the Flipped Classroom: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Wozny, Nathan; Balser, Cary; Ives, Drew

2018-01-01

Despite recent interest in flipped classrooms, rigorous research evaluating their effectiveness is sparse. In this study, the authors implement a randomized controlled trial to evaluate the effect of a flipped classroom technique relative to a traditional lecture in an introductory undergraduate econometrics course. Random assignment enables the…

Teacher Effectiveness and Causal Inference in Observational Studies

ERIC Educational Resources Information Center

Rose, Roderick A.

2013-01-01

An important target of education policy is to improve overall teacher effectiveness using evidence-based policies. Randomized control trials (RCTs), which randomly assign study participants or groups of participants to treatment and control conditions, are not always practical or possible and observational studies using rigorous quasi-experimental…

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

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.

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…

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.

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.

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.

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,…

Outcomes from a School-Randomized Controlled Trial of Steps to Respect: A Bullying Prevention Program

ERIC Educational Resources Information Center

Brown, Eric C.; Low, Sabina; Smith, Brian H.; Haggerty, Kevin P.

2011-01-01

This study reports the outcomes of a randomized controlled trial of Steps to Respect: A Bullying Prevention Program conducted in 33 California elementary schools. Schools were matched on school demographic characteristics and assigned randomly to intervention or waitlisted control conditions. Outcome measures were obtained from (a) all school…

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

ERIC Educational Resources Information Center

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

2006-01-01

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

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…

Everolimus for the Treatment of Advanced Pancreatic Neuroendocrine Tumors: Overall Survival and Circulating Biomarkers From the Randomized, Phase III RADIANT-3 Study.

PubMed

Yao, James C; Pavel, Marianne; Lombard-Bohas, Catherine; Van Cutsem, Eric; Voi, Maurizio; Brandt, Ulrike; He, Wei; Chen, David; Capdevila, Jaume; de Vries, Elisabeth G E; Tomassetti, Paola; Hobday, Timothy; Pommier, Rodney; Öberg, Kjell

2016-11-10

Purpose Everolimus improved median progression-free survival by 6.4 months in patients with advanced pancreatic neuroendocrine tumors (NET) compared with placebo in the RADIANT-3 study. Here, we present the final overall survival (OS) data and data on the impact of biomarkers on OS from the RADIANT-3 study. Methods Patients with advanced, progressive, low- or intermediate-grade pancreatic NET were randomly assigned to everolimus 10 mg/day (n = 207) or placebo (n = 203). Crossover from placebo to open-label everolimus was allowed on disease progression. Ongoing patients were unblinded after final progression-free survival analysis and could transition to open-label everolimus at the investigator's discretion (extension phase). OS analysis was performed using a stratified log-rank test in the intent-to-treat population. The baseline levels of chromogranin A, neuron-specific enolase, and multiple soluble angiogenic biomarkers were determined and their impact on OS was explored. Results Of 410 patients who were enrolled between July 2007 and March 2014, 225 received open-label everolimus, including 172 patients (85%) randomly assigned initially to the placebo arm. Median OS was 44.0 months (95% CI, 35.6 to 51.8 months) for those randomly assigned to everolimus and 37.7 months (95% CI, 29.1 to 45.8 months) for those randomly assigned to placebo (hazard ratio, 0.94; 95% CI, 0.73 to 1.20; P = .30). Elevated baseline chromogranin A, neuron-specific enolase, placental growth factor, and soluble vascular endothelial growth factor receptor 1 levels were poor prognostic factors for OS. The most common adverse events included stomatitis, rash, and diarrhea. Conclusion Everolimus was associated with a median OS of 44 months in patients with advanced, progressive pancreatic NET, the longest OS reported in a phase III study for this population. Everolimus was associated with a survival benefit of 6.3 months, although this finding was not statistically significant. Crossover of patients likely confounded the OS results.

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

ERIC Educational Resources Information Center

Rollins, Karen F.

2012-01-01

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

Unbiased Causal Inference from an Observational Study: Results of a Within-Study Comparison

ERIC Educational Resources Information Center

Pohl, Steffi; Steiner, Peter M.; Eisermann, Jens; Soellner, Renate; Cook, Thomas D.

2009-01-01

Adjustment methods such as propensity scores and analysis of covariance are often used for estimating treatment effects in nonexperimental data. Shadish, Clark, and Steiner used a within-study comparison to test how well these adjustments work in practice. They randomly assigned participating students to a randomized or nonrandomized experiment.…

Investigating a Tier 1 Intervention Focused on Proportional Reasoning: A Follow-Up Study

ERIC Educational Resources Information Center

Jitendra, Asha K.; Harwell, Michael R.; Karl, Stacy R.; Simonson, Gregory R.; Slater, Susan C.

2017-01-01

This randomized controlled study investigated the efficacy of a Tier 1 intervention--schema-based instruction--designed to help students with and without mathematics difficulties (MD) develop proportional reasoning. Twenty seventh-grade teachers/classrooms were randomly assigned to a treatment condition (schema-based instruction) or control…

Strategies for Improving Power in School-Randomized Studies of Professional Development

ERIC Educational Resources Information Center

Kelcey, Ben; Phelps, Geoffrey

2013-01-01

Objectives: Group-randomized designs are well suited for studies of professional development because they can accommodate programs that are delivered to intact groups (e.g., schools), the collaborative nature of professional development, and extant teacher/school assignments. Though group designs may be theoretically favorable, prior evidence has…

Efficiency of a Care Coordination Model: A Randomized Study with Stroke Patients

ERIC Educational Resources Information Center

Claiborne, Nancy

2006-01-01

Objectives: This study investigated the efficiency of a social work care coordination model for stroke patients. Care coordination addresses patient care and treatment resources across the health care system to reduce risk, improve clinical outcomes, and maximize efficiency. Method: A randomly assigned, pre-post experimental design measured…

Treatment Assignment Guesses by Study Participants in a Double-Blind Dose Escalation Clinical Trial of Saw Palmetto

PubMed Central

Moore, Page; Kusek, John; Barry, Michael

2014-01-01

Abstract Objectives: This report assesses participant perception of treatment assignment in a randomized, double-blind, placebo-controlled trial of saw palmetto for the treatment of benign prostatic hyperplasia (BCM). Design: Participants randomized to receive saw palmetto were instructed to take one 320 mg gelcap daily for the first 24 weeks, two 320 mg gelcaps daily for the second 24 weeks, and three 320 mg gelcaps daily for the third 24 weeks. Study participants assigned to placebo were instructed to take the same number of matching placebo gelcaps in each time period. At 24, 48, and 72 weeks postrandomization, the American Urological Association Symptom Index (AUA-SI) was administered and participants were asked to guess their treatment assignment. Settings: The study was conducted at 11 clinical centers in North America. Participants: Study participants were men, 45 years and older, with moderate to low severe BPH symptoms, randomized to saw palmetto (N=151) or placebo (N=155). Outcome measures: Treatment arms were compared with respect to the distribution of participant guesses of treatment assignment. Results: For participants assigned to saw palmetto, 22.5%, 24.7%, and 29.8% correctly thought they were taking saw palmetto, and 37.3%, 40.0%, and 44.4% incorrectly thought they were on placebo at 24, 48, and 72 weeks, respectively. For placebo participants, 21.8%, 27.4%, and 25.2% incorrectly thought they were on saw palmetto, and 41.6%, 39.9%, and 42.6% correctly thought they were on placebo at 24, 48, and 72 weeks, respectively. The treatment arms did not vary with respect to the distributions of participants who guessed they were on saw palmetto (p=0.823) or placebo (p=0.893). Participants who experienced an improvement in AUA-SI were 2.16 times more likely to think they were on saw palmetto. Conclusions: Blinding of treatment assignment was successful in this study. Improvement in BPH-related symptoms was associated with the perception that participants were taking saw palmetto. PMID:23383975

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…

Sensitivity Analysis for Multivalued Treatment Effects: An Example of a Cross-Country Study of Teacher Participation and Job Satisfaction

ERIC Educational Resources Information Center

Chang, Chi

2015-01-01

It is known that interventions are hard to assign randomly to subjects in social psychological studies, because randomized control is difficult to implement strictly and precisely. Thus, in nonexperimental studies and observational studies, controlling the impact of covariates on the dependent variables and addressing the robustness of the…

The Impact of Anonymous and Assigned Use of Student Response Systems on Student Achievement

ERIC Educational Resources Information Center

Poole, Dawn

2012-01-01

This study examined the impact of two approaches to use of student response systems (SRSs) on achievement in a study designed to better understand effective use of the devices. One condition was anonymous use of SRSs, in which graduate students selected a random clicker when entering the classroom. The second condition assigned devices to 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.

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

Use of Matrix Sampling Procedures to Assess Achievement in Solving Open Addition and Subtraction Sentences.

ERIC Educational Resources Information Center

Montague, Margariete A.

This study investigated the feasibility of concurrently and randomly sampling examinees and items in order to estimate group achievement. Seven 32-item tests reflecting a 640-item universe of simple open sentences were used such that item selection (random, systematic) and assignment (random, systematic) of items (four, eight, sixteen) to forms…

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…

Effect of Educational Package on Lifestyle of Primiparous Mothers during Postpartum Period: A Randomized Controlled Clinical Trial

ERIC Educational Resources Information Center

Khodabandeh, Farzaneh; Mirghafourvand, Mojgan; KamaliFard, Mahin; Mohammad-Alizadeh-Charandabi, Sakineh; Asghari Jafarabadi, Mohammad

2017-01-01

A healthy lifestyle is important for mothers during the postpartum period. This study was conducted to determine the effects of a lifestyle educational package in primiparous women. This randomized clinical trial was conducted on 220 mothers assigned to two groups using block randomization. In the intervention group, the mothers received…

A Randomized Controlled Trial of a Standardized Behavior Management Intervention for Students with Externalizing Behavior

ERIC Educational Resources Information Center

Forster, Martin; Sundell, Knut; Morris, Richard J.; Karlberg, Martin; Melin, Lennart

2012-01-01

This study reports the results from a Swedish randomized controlled trial of a standardized behavior management intervention. The intervention targeted students with externalizing behavior in a regular education setting. First- and second-grade students (N = 100) from 38 schools were randomly assigned to either the intervention or an active…

Using Audit Information to Adjust Parameter Estimates for Data Errors in Clinical Trials

PubMed Central

Shepherd, Bryan E.; Shaw, Pamela A.; Dodd, Lori E.

2013-01-01

Background Audits are often performed to assess the quality of clinical trial data, but beyond detecting fraud or sloppiness, the audit data is generally ignored. In earlier work using data from a non-randomized study, Shepherd and Yu (2011) developed statistical methods to incorporate audit results into study estimates, and demonstrated that audit data could be used to eliminate bias. Purpose In this manuscript we examine the usefulness of audit-based error-correction methods in clinical trial settings where a continuous outcome is of primary interest. Methods We demonstrate the bias of multiple linear regression estimates in general settings with an outcome that may have errors and a set of covariates for which some may have errors and others, including treatment assignment, are recorded correctly for all subjects. We study this bias under different assumptions including independence between treatment assignment, covariates, and data errors (conceivable in a double-blinded randomized trial) and independence between treatment assignment and covariates but not data errors (possible in an unblinded randomized trial). We review moment-based estimators to incorporate the audit data and propose new multiple imputation estimators. The performance of estimators is studied in simulations. Results When treatment is randomized and unrelated to data errors, estimates of the treatment effect using the original error-prone data (i.e., ignoring the audit results) are unbiased. In this setting, both moment and multiple imputation estimators incorporating audit data are more variable than standard analyses using the original data. In contrast, in settings where treatment is randomized but correlated with data errors and in settings where treatment is not randomized, standard treatment effect estimates will be biased. And in all settings, parameter estimates for the original, error-prone covariates will be biased. Treatment and covariate effect estimates can be corrected by incorporating audit data using either the multiple imputation or moment-based approaches. Bias, precision, and coverage of confidence intervals improve as the audit size increases. Limitations The extent of bias and the performance of methods depend on the extent and nature of the error as well as the size of the audit. This work only considers methods for the linear model. Settings much different than those considered here need further study. Conclusions In randomized trials with continuous outcomes and treatment assignment independent of data errors, standard analyses of treatment effects will be unbiased and are recommended. However, if treatment assignment is correlated with data errors or other covariates, naive analyses may be biased. In these settings, and when covariate effects are of interest, approaches for incorporating audit results should be considered. PMID:22848072

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

PubMed

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

2018-04-01

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

Effects of Selected Meditative Asanas on Kinaesthetic Perception and Speed of Movement

ERIC Educational Resources Information Center

Singh, Kanwaljeet; Bal, Baljinder S.; Deol, Nishan S.

2009-01-01

Study aim: To assess the effects of selected meditative "asanas" on kinesthetic perception and movement speed. Material and methods: Thirty randomly selected male students aged 18-24 years volunteered to participate in the study. They were randomly assigned into two groups: A (medidative) and B (control). The Nelson's movement speed and…

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...

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…

Group Versus Individual Counseling: A Junior College Study. Final Report.

ERIC Educational Resources Information Center

Aughinbaugh, Lorine A.

Increases in junior college enrollment, coupled with a shortage of qualified guidance personnel, have forced many colleges to rely more heavily on group than on individual counseling for students. In the fall of 1965, students entering American River College were randomly assigned to either group or individual sessions, or not assigned, and these…

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.

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...

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.

The High/Scope Perry Preschool Study: A Case Study in Random Assignment.

ERIC Educational Resources Information Center

Schweinhart, Lawrence J.

2000-01-01

Studied the long-term benefits of preschool programs for young children living in poverty in the High/Scope Perry Preschool Study, which examined the lives of 123 African Americans randomly divided into a preschool treatment group and a no-preschool comparison group. Cost-benefit analyses of data on these students to age 27 show beneficial effects…

Sequential Multiple Assignment Randomized Trial (SMART) with Adaptive Randomization for Quality Improvement in Depression Treatment Program

PubMed Central

Chakraborty, Bibhas; Davidson, Karina W.

2015-01-01

Summary Implementation study is an important tool for deploying state-of-the-art treatments from clinical efficacy studies into a treatment program, with the dual goals of learning about effectiveness of the treatments and improving the quality of care for patients enrolled into the program. In this article, we deal with the design of a treatment program of dynamic treatment regimens (DTRs) for patients with depression post acute coronary syndrome. We introduce a novel adaptive randomization scheme for a sequential multiple assignment randomized trial of DTRs. Our approach adapts the randomization probabilities to favor treatment sequences having comparatively superior Q-functions used in Q-learning. The proposed approach addresses three main concerns of an implementation study: it allows incorporation of historical data or opinions, it includes randomization for learning purposes, and it aims to improve care via adaptation throughout the program. We demonstrate how to apply our method to design a depression treatment program using data from a previous study. By simulation, we illustrate that the inputs from historical data are important for the program performance measured by the expected outcomes of the enrollees, but also show that the adaptive randomization scheme is able to compensate poorly specified historical inputs by improving patient outcomes within a reasonable horizon. The simulation results also confirm that the proposed design allows efficient learning of the treatments by alleviating the curse of dimensionality. PMID:25354029

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.

Data-Division-Specific Robustness and Power of Randomization Tests for ABAB Designs

ERIC Educational Resources Information Center

Manolov, Rumen; Solanas, Antonio; Bulte, Isis; Onghena, Patrick

2010-01-01

This study deals with the statistical properties of a randomization test applied to an ABAB design in cases where the desirable random assignment of the points of change in phase is not possible. To obtain information about each possible data division, the authors carried out a conditional Monte Carlo simulation with 100,000 samples for each…

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

ERIC Educational Resources Information Center

Liao, Chi-Wen; Livingston, Samuel A.

2008-01-01

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

A Comparison of Single Sample and Bootstrap Methods to Assess Mediation in Cluster Randomized Trials

ERIC Educational Resources Information Center

Pituch, Keenan A.; Stapleton, Laura M.; Kang, Joo Youn

2006-01-01

A Monte Carlo study examined the statistical performance of single sample and bootstrap methods that can be used to test and form confidence interval estimates of indirect effects in two cluster randomized experimental designs. The designs were similar in that they featured random assignment of clusters to one of two treatment conditions and…

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…

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

ERIC Educational Resources Information Center

Charlier, Nathalie; De Fraine, Bieke

2013-01-01

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

The study of combining Latin Hypercube Sampling method and LU decomposition method (LULHS method) for constructing spatial random field

NASA Astrophysics Data System (ADS)

WANG, P. T.

2015-12-01

Groundwater modeling requires to assign hydrogeological properties to every numerical grid. Due to the lack of detailed information and the inherent spatial heterogeneity, geological properties can be treated as random variables. Hydrogeological property is assumed to be a multivariate distribution with spatial correlations. By sampling random numbers from a given statistical distribution and assigning a value to each grid, a random field for modeling can be completed. Therefore, statistics sampling plays an important role in the efficiency of modeling procedure. Latin Hypercube Sampling (LHS) is a stratified random sampling procedure that provides an efficient way to sample variables from their multivariate distributions. This study combines the the stratified random procedure from LHS and the simulation by using LU decomposition to form LULHS. Both conditional and unconditional simulations of LULHS were develpoed. The simulation efficiency and spatial correlation of LULHS are compared to the other three different simulation methods. The results show that for the conditional simulation and unconditional simulation, LULHS method is more efficient in terms of computational effort. Less realizations are required to achieve the required statistical accuracy and spatial correlation.

The Effects of Self- and Peer-Monitoring in Social Studies Performance of Students with Learning Disabilities and Low Achieving Students

ERIC Educational Resources Information Center

Kim, Woori; Ok, Min Wook; Yoo, Yongseok

2018-01-01

This study employed group randomized trials to investigate the effects of self- and peer-monitoring on the academic vocabulary and content knowledge of students with learning disabilities and low achieving students in social studies. Fourth grade students were randomly assigned to either treatment or control groups on a class level. Results…

Validating Components of Teacher Effectiveness: A Random Assignment Study of Value-Added, Observation, and Survey Scores

ERIC Educational Resources Information Center

Bacher-Hicks, Andrew; Chin, Mark; Kane, Thomas J.; Staiger, Douglas O.

2015-01-01

Policy changes from the past decade have resulted in a growing interest in identifying effective teachers and their characteristics. This study is the third study to use data from a randomized experiment to test the validity of measures of teacher effectiveness. The authors collected effectiveness measures across three school years from three…

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.

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

ERIC Educational Resources Information Center

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

2011-01-01

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

A Cardiovascular Risk Reduction Program for American Indians with Metabolic Syndrome: The Balance Study

ERIC Educational Resources Information Center

Lee, Elisa T.; Jobe, Jared B.; Yeh, Jeunliang; Ali, Tauqeer; Rhoades, Everett R.; Knehans, Allen W.; Willis, Diane J.; Johnson, Melanie R.; Zhang, Ying; Poolaw, Bryce; Rogers, Billy

2012-01-01

The Balance Study is a randomized controlled trial designed to reduce cardiovascular disease (CVD) risk in 200 American Indian (AI) participants with metabolic syndrome who reside in southwestern Oklahoma. Major risk factors targeted include weight, diet, and physical activity. Participants are assigned randomly to one of two groups, a guided or a…

Lesson Study to Scale up Research-Based Knowledge: A Randomized, Controlled Trial of Fractions Learning

ERIC Educational Resources Information Center

Lewis, Catherine; Perry, Rebecca

2017-01-01

An understanding of fractions eludes many U.S. students, and research-based knowledge about fraction, such as the utility of linear representations, has not broadly influenced instruction. This randomized trial of lesson study supported by mathematical resources assigned 39 educator teams across the United States to locally managed lesson study…

The Role of Exposure Condition in the Effectiveness of Explicit Correction

ERIC Educational Resources Information Center

Yilmaz, Yucel

2016-01-01

This article reports on a study that investigated the effects of two feedback exposure conditions on the acquisition of two Turkish morphemes. The study followed a randomized experimental design with an immediate and a delayed posttest. Forty-two Chinese-speaking learners of Turkish were randomly assigned to one of three groups: receivers,…

Building Kindergartners' Number Sense: A Randomized Controlled Study

ERIC Educational Resources Information Center

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

2012-01-01

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

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…

Improving the Efficiency and Effectiveness of Grading through the Use of Computer-Assisted Grading Rubrics

ERIC Educational Resources Information Center

Anglin, Linda; Anglin, Kenneth; Schumann, Paul L.; Kaliski, John A.

2008-01-01

This study tests the use of computer-assisted grading rubrics compared to other grading methods with respect to the efficiency and effectiveness of different grading processes for subjective assignments. The test was performed on a large Introduction to Business course. The students in this course were randomly assigned to four treatment groups…

Order of Verdict Consideration and Decision Rule Effects on Mock Jury Decision Making.

ERIC Educational Resources Information Center

Olaye, Imafidon M.

A study investigated the effects of order verdict consideration and decision rule on jury verdicts. After reading the summary of an actual trial, 240 mock jurors drawn from undergraduate communications classes were randomly assigned to six-member juries. Jury assignments were made under two verdict orders (ascending and descending order of…

Effects of Expressive Writing Effects on Disgust and Anxiety in a Subsequent Dissection

ERIC Educational Resources Information Center

Randler, Christoph; Wüst-Ackermann, Peter; im Kampe, Viola Otte; Meyer-Ahrens, Inga H.; Tempel, Benjamin J.; Vollmer, Christian

2015-01-01

Emotions influence motivation and achievement, but negative emotions have rarely been assessed in science education. In this study, we assessed the influence of two different expressive writing assignments on disgust and anxiety in university students prior to the dissection of a trout. We randomly assigned students to one of two expressive…

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...

Effects of Higher and Lower Level Writing-To-Learn Assignments on Higher and Lower Level Examination Questions

ERIC Educational Resources Information Center

Nevid, Jeffrey S.; Ambrose, Michael A.; Pyun, Yea Seul

2017-01-01

Our study examined whether brief writing-to-learn assignments linked to lower and higher levels in Bloom's taxonomy affected performance differentially on examination performance in assessing these skill levels. Using a quasi-random design, 91 undergraduate students in an introductory psychology class completed eight lower level and eight higher…

Weblogs in Teacher Education Internships: Promoting Reflection and Self-Efficacy While Reducing Stress?

ERIC Educational Resources Information Center

Petko, Dominik; Egger, Nives; Cantieni, Andrea

2017-01-01

The study examines the use of weblogs in teacher education internships and its impact on student stress levels, self-efficacy, and reflective abilities. One hundred and seventy-six student teachers were randomly assigned to five groups. Four groups used weblogs (a) with emotion-focused or with problem-focused writing assignments in combination (b)…

Biases in Estimating Treatment Effects Due to Attrition in Randomized Controlled Trials and Cluster Randomized Controlled Trials: A Simulation Study

ERIC Educational Resources Information Center

Dong, Nianbo; Lipsey, Mark W.

2011-01-01

Attrition occurs when study participants who were assigned to the treatment and control conditions do not provide outcome data and thus do not contribute to the estimation of the treatment effects. It is very common in experimental studies in education as illustrated, for instance, in a meta-analysis studying "the effects of attrition on baseline…

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.

A multiple imputation strategy for sequential multiple assignment randomized trials

PubMed Central

Shortreed, Susan M.; Laber, Eric; Stroup, T. Scott; Pineau, Joelle; Murphy, Susan A.

2014-01-01

Sequential multiple assignment randomized trials (SMARTs) are increasingly being used to inform clinical and intervention science. In a SMART, each patient is repeatedly randomized over time. Each randomization occurs at a critical decision point in the treatment course. These critical decision points often correspond to milestones in the disease process or other changes in a patient’s health status. Thus, the timing and number of randomizations may vary across patients and depend on evolving patient-specific information. This presents unique challenges when analyzing data from a SMART in the presence of missing data. This paper presents the first comprehensive discussion of missing data issues typical of SMART studies: we describe five specific challenges, and propose a flexible imputation strategy to facilitate valid statistical estimation and inference using incomplete data from a SMART. To illustrate these contributions, we consider data from the Clinical Antipsychotic Trial of Intervention and Effectiveness (CATIE), one of the most well-known SMARTs to date. PMID:24919867

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.

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...

Receipt of Preventive Services After Oregon's Randomized Medicaid Experiment.

PubMed

Marino, Miguel; Bailey, Steffani R; Gold, Rachel; Hoopes, Megan J; O'Malley, Jean P; Huguet, Nathalie; Heintzman, John; Gallia, Charles; McConnell, K John; DeVoe, Jennifer E

2016-02-01

It is predicted that gaining health insurance via the Affordable Care Act will result in increased rates of preventive health services receipt in the U.S., primarily based on self-reported findings from previous health insurance expansion studies. This study examined the long-term (36-month) impact of Oregon's 2008 randomized Medicaid expansion ("Oregon Experiment") on receipt of 12 preventive care services in community health centers using electronic health record data. Demographic data from adult (aged 19-64 years) Oregon Experiment participants were probabilistically matched to electronic health record data from 49 Oregon community health centers within the OCHIN community health information network (N=10,643). Intent-to-treat analyses compared receipt of preventive services over a 36-month (2008-2011) period among those randomly assigned to apply for Medicaid versus not assigned, and instrumental variable analyses estimated the effect of actually gaining Medicaid coverage on preventive services receipt (data collected in 2012-2014; analysis performed in 2014-2015). Intent-to-treat analyses revealed statistically significant differences between patients randomly assigned to apply for Medicaid (versus not assigned) for 8 of 12 assessed preventive services. In intent-to-treat analyses, Medicaid coverage significantly increased the odds of receipt of most preventive services (ORs ranging from 1.04 [95% CI=1.02, 1.06] for smoking assessment to 1.27 [95% CI=1.02, 1.57] for mammography). Rates of preventive services receipt will likely increase as community health center patients gain insurance through Affordable Care Act expansions. Continued effort is needed to increase health insurance coverage in an effort to decrease health disparities in vulnerable populations. Copyright © 2016 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Receipt of Preventive Services After Oregon’s Randomized Medicaid Experiment

PubMed Central

Marino, Miguel; Bailey, Steffani R.; Gold, Rachel; Hoopes, Megan J.; O’Malley, Jean P.; Huguet, Nathalie; Heintzman, John; Gallia, Charles; McConnell, K. John; DeVoe, Jennifer E.

2015-01-01

Introduction It is predicted that gaining health insurance via the Affordable Care Act will result in increased rates of preventive health services receipt in the U.S, primarily based on self-reported findings from previous health insurance expansion studies. This study examined the long-term (36-month) impact of Oregon’s 2008 randomized Medicaid expansion (“Oregon Experiment”) on receipt of 12 preventive care services in community health centers using electronic health record data. Methods Demographic data from adult (aged 19–64 years) Oregon Experiment participants were probabilistically matched to electronic health record data from 49 Oregon community health centers within the OCHIN community health information network (N=10,643). Intent-to-treat analyses compared receipt of preventive services over a 36-month (2008–2011) period among those randomly assigned to apply for Medicaid versus not assigned, and instrumental variable analyses estimated the effect of actually gaining Medicaid coverage on preventive services receipt (data collected in 2012–2014; analysis performed in 2014–2015). Results Intent-to-treat analyses revealed statistically significant differences between patients randomly assigned to apply for Medicaid (versus not assigned) for eight of 12 assessed preventive services. In intent-to-treat[MM1] analyses, Medicaid coverage significantly increased the odds of receipt of most preventive services (ORs ranging from 1.04 [95% CI=1.02, 1.06] for smoking assessment to 1.27 [95% CI=1.02, 1.57] for mammography). Conclusions Rates of preventive services receipt will likely increase as community health center patients gain insurance through Affordable Care Act expansions. Continued effort is needed to increase health insurance coverage in an effort to decrease health disparities in vulnerable populations. PMID:26497264

German adjuvant intergroup node-positive study: a phase III trial to compare oral ibandronate versus observation in patients with high-risk early breast cancer.

PubMed

von Minckwitz, Gunter; Möbus, Volker; Schneeweiss, Andreas; Huober, Jens; Thomssen, Christoph; Untch, Michael; Jackisch, Christian; Diel, Ingo J; Elling, Dirk; Conrad, Bettina; Kreienberg, Rolf; Müller, Volkmar; Lück, Hans-Joachim; Bauerfeind, Ingo; Clemens, Michael; Schmidt, Marcus; Noeding, Stefanie; Forstbauer, Helmut; Barinoff, Jana; Belau, Antje; Nekljudova, Valentina; Harbeck, Nadia; Loibl, Sibylle

2013-10-01

Bisphosphonates prevent skeletal-related events in patients with metastatic breast cancer. Their effect in early breast cancer is controversial. Ibandronate is an orally and intravenously available amino-bisphosphonate with a favorable toxicity profile. It therefore qualifies as potential agent for adjuvant use. The GAIN (German Adjuvant Intergroup Node-Positive) study was an open-label, randomized, controlled phase III trial with a 2 × 2 factorial design. Patients with node-positive early breast cancer were randomly assigned 1:1 to two different dose-dense chemotherapy regimens and 2:1 to ibandronate 50 mg per day orally for 2 years or observation. In all, 2,640 patients and 728 events were estimated to be required to demonstrate an increase in disease-free survival (DFS) by ibandronate from 75% to 79.5% by using a two-sided α = .05 and 1-β of 80%. We report here the efficacy analysis for ibandronate, which was released by the independent data monitoring committee because the futility boundary was not crossed after 50% of the required DFS events were observed. Between June 2004 and August 2008, 2,015 patients were randomly assigned to ibandronate and 1,008 to observation. Patients randomly assigned to ibandronate showed no superior DFS or overall survival (OS) compared with patients randomly assigned to observation (DFS: hazard ratio, 0.945; 95% CI, 0.768 to 1.161; P = .589; OS: HR, 1.040; 95% CI, 0.763 to 1.419; P = .803). DFS was numerically longer if ibandronate was used in patients younger than 40 years or older than 60 years compared with patients age 40 to 59 years (test for interaction P = .093). Adjuvant treatment with oral ibandronate did not improve outcome of patients with high-risk early breast cancer who received dose-dense chemotherapy.

Evaluation of a School-Based Teen Obesity Prevention Minimal Intervention

ERIC Educational Resources Information Center

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

2008-01-01

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

The Implications of "Contamination" for Experimental Design in Education

ERIC Educational Resources Information Center

Rhoads, Christopher H.

2011-01-01

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

Consequences of "Minimal" Group Affiliations in Children

ERIC Educational Resources Information Center

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

2011-01-01

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

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…

Web-Based Cognitive Behavioral Therapy Intervention for the Prevention of Suicidal Ideation in Medical Interns: A Randomized Clinical Trial.

PubMed

Guille, Constance; Zhao, Zhuo; Krystal, John; Nichols, Breck; Brady, Kathleen; Sen, Srijan

2015-12-01

In the United States, approximately 1 physician dies by suicide every day. Training physicians are at particularly high risk, with suicidal ideation increasing more than 4-fold during the first 3 months of internship year. Despite this increase, to our knowledge, very few efforts have been made to prevent the escalation of suicidal thoughts among training physicians. To assess the effectiveness of a web-based cognitive behavioral therapy (wCBT) program delivered prior to the start of internship year in the prevention of suicidal ideation in medical interns. A randomized clinical trial conducted at 2 university hospitals with 199 interns from multiple specialties during academic years 2009-2010 or 2011-2012. The current study was conducted from May 2009 to June 2010 and May 2011 to June 2012, and data were analyzed using intent-to-treat principles, including last observation carried forward. Interns were randomly assigned to 2 study groups (wCBT and attention-control group [ACG]), and completed study activities lasting 30 minutes each week for 4 weeks prior to starting internship year. Participants assigned to wCBT completed online CBT modules and those assigned to ACG received emails with general information about depression, suicidal thinking, and local mental health professionals. The Patient Health Questionnaire-9 was used to assess suicidal ideation (ie, "thoughts that you would be better off dead or hurting yourself in some way") prior to the start of intern year and at 3-month intervals throughout the year. A total of 62.2% of interns (199 of 320) agreed to take part in the study; 100 were assigned to the wCBT group and 99 to the ACG. During at least 1 point over the course of internship year, 12% of interns (12 of 100) assigned to wCBT endorsed suicidal ideation compared with 21.2% of interns (21 of 99) assigned to ACG. After adjusting for covariates identified a priori that have previously shown to increase the risk for suicidal ideation, interns assigned to wCBT were less likely to endorse suicidal ideation during internship year (relative risk, 0.40; 95% CI, 0.17- 0.91; P = .03) compared with those assigned to ACG. This study demonstrates that a free, easily accessible, brief wCBT program is associated with reduced likelihood of suicidal ideation among medical interns. Prevention programs with these characteristics could be easily disseminated to medical training programs across the country. anzctr.org.au Identifier: ACTRN12610000628044.

"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.

Thirty-Month Follow-Up of Drinking Moderation Training for Women: A Randomized Clinical Trial

ERIC Educational Resources Information Center

Walitzer, Kimberly S.; Connors, Gerard J.

2007-01-01

This study examined the durability of a group-based drinking moderation training for heavily drinking women reporting low physical dependence on alcohol. A 30-month follow-up of participants was conducted based on a previous study of 144 women randomly assigned to treatment conditions (G. J. Connors & K. S. Walitzer, 2001). Thirty-month follow-up…

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…

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

ERIC Educational Resources Information Center

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

2011-01-01

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

Effects of Joint Attention Mediated Learning for Toddlers with Autism Spectrum Disorders: An Initial Randomized Controlled Study

ERIC Educational Resources Information Center

Schertz, Hannah H.; Odom, Samuel L.; Baggett, Kathleen M.; Sideris, John H.

2013-01-01

The purpose of this study was to determine effects of the Joint Attention Mediated Learning (JAML) intervention on acquisition of joint attention and other early social communication competencies for toddlers with autism spectrum disorders (ASD). Twenty-three parents and their toddlers were randomly assigned to JAML or a control condition.…

An Assessment of Health Behavior Peer Effects in Peking University Dormitories: A Randomized Cluster-Assignment Design for Interference

PubMed Central

Yuan, Changzheng; Lv, Jun; VanderWeele, Tyler J.

2013-01-01

Background Relatively little is known about the peer influence in health behaviors within university dormitory rooms. Moreover, in China, the problem of unhealthy behaviors among university students has not yet been sufficiently recognized. We thus investigated health behavior peer influence in Peking University dormitories utilizing a randomized cluster-assignment design. Methods Study design: Cross-sectional in-dormitory survey. Study population: Current students from Peking University Health Science Center from April to June, 2009. Measurement: Self-reported questionnaire on health behaviors: physical activity (including bicycling), dietary intake and tobacco use. Results Use of bicycle, moderate-intensity exercise, frequency of sweet food and soybean milk intake, frequency of roasted/baked/toasted food intake were behaviors significantly or marginally significantly affected by peer influence. Conclusion Health behavior peer effects exist within dormitory rooms among university students. This could provide guidance on room assignment, or inform intervention programs. Examining these may demand attention from university administrators and policy makers. PMID:24040377

A Randomized Pilot Study of the Engaging Moms Program for Family Drug Court

PubMed Central

Dakof, Gayle A.; Cohen, Jeri B.; Henderson, Craig E.; Duarte, Eliette; Boustani, Maya; Blackburn, Audra; Venzer, Ellen; Hawes, Sam

2010-01-01

In response to the need for effective drug court interventions, the effectiveness of the Engaging Moms Program (EMP) versus intensive case management services (ICMS) on multiple outcomes for mothers enrolled in family drug court was investigated. In this intent-to-treat study, mothers (N = 62) were randomly assigned to either usual drug court care or the Engaging Moms drug court program. Mothers were assessed at intake, and 3, 6, 12, and 18 months following intake. Results indicated that at 18 months post drug court enrollment, 77% of mothers assigned to EMP versus 55% of mothers assigned to ICMS had positive child welfare dispositions. There were statistically significant time effects for both intervention groups on multiple outcomes including substance use, mental health, parenting practices, and family functioning. EMP showed equal or better improvement than ICMS on all outcomes. The results suggest that EMP in family drug court is a viable and promising intervention approach to reduce maternal addiction and child maltreatment. PMID:20116961

Design approaches to experimental mediation☆

PubMed Central

Pirlott, Angela G.; MacKinnon, David P.

2016-01-01

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

Design approaches to experimental mediation.

PubMed

Pirlott, Angela G; MacKinnon, David P

2016-09-01

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

It Takes Two Shining Lights to Brighten the Room: Peer Effects with Random Roommate Assignments

ERIC Educational Resources Information Center

Zhang, Liang; Pu, Shi

2017-01-01

We used housing assignment data from a college in China to investigate peer effects on college grades. Study results provided some evidence for peer effects in college housing units. First, peer effects through means occurred during both fall and spring semester of the first year in college, with estimated effect much larger than that in previous…

Do low step count goals inhibit walking behavior: a randomized controlled study.

PubMed

Anson, Denis; Madras, Diane

2016-07-01

Confirmation and quantification of observed differences in goal-directed walking behavior. Single-blind, split-half randomized trial. Small rural university, Pennsylvania, United States. A total of 94 able-bodied subjects (self-selected volunteer students, faculty and staff of a small university) were randomly assigned walking goals, and 53 completed the study. Incentivized pedometer-monitored program requiring recording the step-count for 56-days into a custom-made website providing daily feedback. Steps logged per day. During the first half of the study, the 5000 and 10,000 step group logged significantly different steps 7500 and 9000, respectively (P > 0.05). During the second half of the study, the 5000 and 10,000 step groups logged 7000 and 8600 steps, respectively (significance P > 0.05). The group switched from 5000 to →10,000 steps logged, 7900 steps for the first half and 9500 steps for the second half (significance P > 0.05). The group switched from 10,000 to 5000 steps logged 9700 steps for the first half and 9000 steps for the second half, which was significant (p > 0.05). Levels of walking behavior are influenced by the goals assigned. Subjects with high goals walk more than those with low goals, even if they do not meet the assigned goal. Reducing goals from a high to low level can reduce walking behavior. © The Author(s) 2015.

Web-Based Cognitive Behavioral Therapy Intervention for the Prevention of Suicidal Ideation in Medical Interns: A Randomized Controlled Trial

PubMed Central

Guille, Constance; Zhao, Zhuo; Krystal, John; Nichols, Breck; Brady, Kathleen; Sen, Srijan

2016-01-01

Importance In the United States, approximately one physician dies by suicide every day. Training physicians are at particularly high risk, with suicidal ideation increasing over four-fold during the first three months of internship year. Despite this dramatic increase, very few efforts have been made to prevent the escalation of suicidal thoughts among training physicians. Objective To assess the effectiveness of a Web-based Cognitive Behavioral Therapy (wCBT) program delivered prior to the start of internship year in the prevention of suicidal ideation in medical interns. Design, Setting and Participants A randomized controlled trial conducted at two university hospitals with 199 interns from multiple specialties during academic years 2009-10 or 2011-12. Interventions Interns were randomly assigned to study groups (wCBT, n=100; attention-control group (ACG), n=99), and completed study activities lasting 30-minutes each week for four weeks prior to starting internship year. Subjects assigned to wCBT completed online-CBT modules and subjects assigned to ACG received emails with general information about depression, suicidal thinking and local mental health providers. Main Outcome Measure The Patient Health Questionnaire (PHQ-9) was employed to assess suicidal ideation (i.e., “thoughts that you would be better off dead, or hurting yourself in some way”) prior to the start of intern year and at 3-month intervals throughout the year. Results 62.2% (199/320) of individuals agreed to take part in the study. During at least one time point over the course of internship year 12% (12/100) of interns assigned to wCBT endorsed suicidal ideation, compared to 21%(21/99) of interns assigned to ACG. After adjusting for covariates identified a priori that have previously shown to increase the risk for suicidal ideation, interns assigned to wCBT were 60% less likely to endorse suicidal ideation during internship year (RR: 0.40, 95% CI 0.17-0.91; p=0.03), compared to those assigned to ACG. Conclusion This study demonstrates that a free, easily accessible, brief wCBT program can help reduce the development of suicidal ideation among medical interns. Prevention programs with these characteristics could be easily disseminated to medical training program across the country. PMID:26535958

Randomized Trial of Reduced-Nicotine Standards for Cigarettes.

PubMed

Donny, Eric C; Denlinger, Rachel L; Tidey, Jennifer W; Koopmeiners, Joseph S; Benowitz, Neal L; Vandrey, Ryan G; al'Absi, Mustafa; Carmella, Steven G; Cinciripini, Paul M; Dermody, Sarah S; Drobes, David J; Hecht, Stephen S; Jensen, Joni; Lane, Tonya; Le, Chap T; McClernon, F Joseph; Montoya, Ivan D; Murphy, Sharon E; Robinson, Jason D; Stitzer, Maxine L; Strasser, Andrew A; Tindle, Hilary; Hatsukami, Dorothy K

2015-10-01

The Food and Drug Administration can set standards that reduce the nicotine content of cigarettes. We conducted a double-blind, parallel, randomized clinical trial between June 2013 and July 2014 at 10 sites. Eligibility criteria included an age of 18 years or older, smoking of five or more cigarettes per day, and no current interest in quitting smoking. Participants were randomly assigned to smoke for 6 weeks either their usual brand of cigarettes or one of six types of investigational cigarettes, provided free. The investigational cigarettes had nicotine content ranging from 15.8 mg per gram of tobacco (typical of commercial brands) to 0.4 mg per gram. The primary outcome was the number of cigarettes smoked per day during week 6. A total of 840 participants underwent randomization, and 780 completed the 6-week study. During week 6, the average number of cigarettes smoked per day was lower for participants randomly assigned to cigarettes containing 2.4, 1.3, or 0.4 mg of nicotine per gram of tobacco (16.5, 16.3, and 14.9 cigarettes, respectively) than for participants randomly assigned to their usual brand or to cigarettes containing 15.8 mg per gram (22.2 and 21.3 cigarettes, respectively; P<0.001). Participants assigned to cigarettes with 5.2 mg per gram smoked an average of 20.8 cigarettes per day, which did not differ significantly from the average number among those who smoked control cigarettes. Cigarettes with lower nicotine content, as compared with control cigarettes, reduced exposure to and dependence on nicotine, as well as craving during abstinence from smoking, without significantly increasing the expired carbon monoxide level or total puff volume, suggesting minimal compensation. Adverse events were generally mild and similar among groups. In this 6-week study, reduced-nicotine cigarettes versus standard-nicotine cigarettes reduced nicotine exposure and dependence and the number of cigarettes smoked. (Funded by the National Institute on Drug Abuse and the Food and Drug Administration Center for Tobacco Products; ClinicalTrials.gov number, NCT01681875.).

Exploring the statistical and clinical impact of two interim analyses on the Phase II design with option for direct assignment.

PubMed

An, Ming-Wen; Mandrekar, Sumithra J; Edelman, Martin J; Sargent, Daniel J

2014-07-01

The primary goal of Phase II clinical trials is to understand better a treatment's safety and efficacy to inform a Phase III go/no-go decision. Many Phase II designs have been proposed, incorporating randomization, interim analyses, adaptation, and patient selection. The Phase II design with an option for direct assignment (i.e. stop randomization and assign all patients to the experimental arm based on a single interim analysis (IA) at 50% accrual) was recently proposed [An et al., 2012]. We discuss this design in the context of existing designs, and extend it from a single-IA to a two-IA design. We compared the statistical properties and clinical relevance of the direct assignment design with two IA (DAD-2) versus a balanced randomized design with two IA (BRD-2) and a direct assignment design with one IA (DAD-1), over a range of response rate ratios (2.0-3.0). The DAD-2 has minimal loss in power (<2.2%) and minimal increase in T1ER (<1.6%) compared to a BRD-2. As many as 80% more patients were treated with experimental vs. control in the DAD-2 than with the BRD-2 (experimental vs. control ratio: 1.8 vs. 1.0), and as many as 64% more in the DAD-2 than with the DAD-1 (1.8 vs. 1.1). We illustrate the DAD-2 using a case study in lung cancer. In the spectrum of Phase II designs, the direct assignment design, especially with two IA, provides a middle ground with desirable statistical properties and likely appeal to both clinicians and patients. Copyright © 2014 Elsevier Inc. All rights reserved.

Clinical study on the therapeutic role of midodrine in non azotemic cirrhotic patients with tense ascites: a double-blind, placebo-controlled, randomized trial.

PubMed

Ali, Ahmed; Farid, Samar; Amin, Mona; Kassem, Mohamed; Al-Garem, Nouman

2014-10-01

Midodrine is an α-agonist prodrug of desglymidodrine used for the management of hypotension. Midodrine has demonstrated usefulness in hepatorenal syndrome. The objective of the present work was to study the role of midodrine in patients with non-azotemic cirrhosis with tense ascites. This prospective randomized double blind placebo-controlled study was conducted on 67 non azotemic inpatients with liver cirrhosis and tense ascites (52 men and 15 women; age range, 45-72). One patient declined to participate in the study, 33 patients were randomly assigned to take midodrine hydrochloride, and 33 patients were randomly assigned to take placebo. Out of 67 enrolled patients, 60 patients (30: in midodrine group; 30: in placebo group) completed the study and 6 patients lost to follow up. Patients were assessed for patients’ characteristics, history of tapping their ascetic fluid, laboratory values, and Doppler parameters before and after the study. Average 24-h urine volume was assessed before and after the start of the study. significant reduction in body weight and abdominal girth was observed after 2 weeks of midodrine therapy. Midodrine appeared to be effective in lowering body weights and abdominal girths of non azotemic cirrhotic patients with tense ascites.

Effects of active/passive interventions on pain, anxiety, and quality of life in women with fibromyalgia: Randomized controlled pilot trial.

PubMed

Ekici, Gamze; Unal, Edibe; Akbayrak, Turkan; Vardar-Yagli, Naciye; Yakut, Yavuz; Karabulut, Erdem

2017-01-01

The authors of this study compared the effects of pilates exercises and connective tissue massage (CTM) on pain intensity; pain-pressure threshold; and tolerance, anxiety, progress, and health-related quality of life in females with fibromyalgia. It was a pilot, assessor masked, randomized controlled trial conducted between January and August of 2013. Twenty-one women with fibromyalgia were randomly assigned to the pilates exercise program (six of whom did not complete the program), and 22 were randomly assigned to CTM (one of whom did not complete this program). Each group received the assigned intervention three times per week during a 4-week period. The Visual Analogue Scale, algometry, State-Trait Anxiety Inventory, Fibromyalgia Impact Questionnaire, and Nottingham Health Profile were used at baseline and at the end of treatments. Significant improvements were found in both groups for all parameters. However, the scores for pain-pressure threshold were significantly elevated and the symptoms of anxiety were significantly diminished in the exercise group compared to the massage group. Thus, exercise and massage might be used to provide improvements in women with fibromyalgia. The exercise group showed more advantages than the massage group and thus might be preferred for patients with fibromyalgia. However, an adequately powered trial is required to determine this with certainty.

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…

Asthma Self-Management Model: Randomized Controlled Trial

ERIC Educational Resources Information Center

Olivera, Carolina M. X.; Vianna, Elcio Oliveira; Bonizio, Roni C.; de Menezes, Marcelo B.; Ferraz, Erica; Cetlin, Andrea A.; Valdevite, Laura M.; Almeida, Gustavo A.; Araujo, Ana S.; Simoneti, Christian S.; de Freitas, Amanda; Lizzi, Elisangela A.; Borges, Marcos C.; de Freitas, Osvaldo

2016-01-01

Information for patients provided by the pharmacist is reflected in adhesion to treatment, clinical results and patient quality of life. The objective of this study was to assess an asthma self-management model for rational medicine use. This was a randomized controlled trial with 60 asthmatic patients assigned to attend five modules presented by…

Occupational Therapy Home Program for Children with Intellectual Disabilities: A Randomized, Controlled Trial

ERIC Educational Resources Information Center

Wuang, Yee-Pay; Ho, Guang-Sheng; Su, Chwen-Yng

2013-01-01

This study aimed to investigate the effectiveness of a proposed occupational therapy home program (OTHP) for children with intellectual disabilities (ID). Children with ID were randomly and equally assigned to OTHP or to no OTHP groups. The primary outcome measures were Canadian Occupational Performance, Bruininks-Oseretsky Test of Motor…

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…

Randomized Trial of Contingent Prizes versus Vouchers in Cocaine-Using Methadone Patients

ERIC Educational Resources Information Center

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

2007-01-01

Contingency management (CM) interventions frequently utilize vouchers as reinforcers, but a prize-based system is also efficacious. This study compared these approaches. Seventy-four cocaine-dependent methadone outpatients were randomly assigned to standard treatment (ST), ST plus a maximum of $585 in contingent vouchers, or ST plus an expected…

Youth-Nominated Support Team for Suicidal Adolescents (Version 1): A Randomized Controlled Trial

ERIC Educational Resources Information Center

King, Cheryl A.; Kramer, Anne; Preuss, Lesli; Kerr, David C. R.; Weisse, Lois; Venkataraman, Sanjeev

2006-01-01

In this study, the authors investigated the efficacy of the Youth-Nominated Support Team-Version 1 (YST-1), a psychoeducational social network intervention, with 289 suicidal, psychiatrically hospitalized adolescents (197 girls, 92 boys). Adolescents were randomly assigned to treatment-as-usual plus YST-1 or treatment-as-usual only. Assessments…

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…

78 FR 54653 - Proposed Data Collections Submitted for Public Comment and Recommendations

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-05

... materials on opinions about CRC screening tests. Each respondent will be randomly assigned to one of three... treatment group that receives a ``No Excuses'' educational flyer designed to dispel many common reasons for... randomly selected from the KN KnowledgePanel[supreg]. A pre-test of study procedures will be conducted...

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…

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-10

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

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

PubMed Central

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

2018-01-01

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

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

PubMed

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

2017-11-01

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

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

PubMed

Weathers, Robert R; Bailey, Michelle Stegman

2014-01-01

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

Sequential multiple-assignment randomized trial design of neurobehavioral treatment for patients with metastatic malignant melanoma undergoing high-dose interferon-alpha therapy.

PubMed

Auyeung, S Freda; Long, Qi; Royster, Erica Bruce; Murthy, Smitha; McNutt, Marcia D; Lawson, David; Miller, Andrew; Manatunga, Amita; Musselman, Dominique L

2009-10-01

Interferon-alpha therapy, which is used to treat metastatic malignant melanoma, can cause patients to develop two distinct neurobehavioral symptom complexes: a mood syndrome and a neurovegetative syndrome. Interferon-alpha effects on serotonin metabolism appear to contribute to the mood and anxiety syndrome, while the neurovegetative syndrome appears to be related to interferon-alpha effects on dopamine. Our goal is to propose a design for utilizing a sequential, multiple assignment, randomized trial design for patients with malignant melanoma to test the relative efficacy of drugs that target serotonin versus dopamine metabolism during 4 weeks of intravenous, then 8 weeks of subcutaneous, interferon-alpha therapy. Patients will be offered participation in a double-blinded, randomized, controlled, 14-week trial involving two treatment phases. During the first month of intravenous interferon-alpha therapy, we will test the hypotheses that escitalopram will be more effective in reducing depressed mood, anxiety, and irritability, whereas methylphenidate will be more effective in diminishing interferon-alpha-induced neurovegetative symptoms, such as fatigue and psychomotor slowing. During the next 8 weeks of subcutaneous interferon therapy, participants whose symptoms do not improve significantly will be randomized to the alternate agent alone versus escitalopram and methylphenidate together. We present a prototype for a single-center, sequential, multiple assignment, randomized trial, which seeks to determine the efficacy of sequenced and targeted treatment for the two distinct symptom complexes suffered by patients treated with interferon-alpha. Because we cannot completely control for external factors, a relevant question is whether or not 'short-term' neuropsychiatric interventions can increase the number of interferon-alpha doses tolerated and improve long-term survival. This sequential, multiple assignment, randomized trial proposes a framework for developing optimal treatment strategies; however, additional studies are needed to determine the best strategy for treating or preventing neurobehavioral symptoms induced by the immunotherapy interferon-alpha.

Cohesion in Sports and Organizational Psychology: An Annotated Bibliography and Suggestions for U.S. Army Aviation (1993 to 2003)

DTIC Science & Technology

2005-04-01

serve as a deterrent to groupthink. The study consisted of 92 male and 56 female undergraduate students randomly assigned to groups. Directive and...attraction serves as the focus of this study. The study used 472 undergraduate psychology students divided into four-person groups. Some groups were made of...used 208 communication students over a one- year period. Work groups of five to seven members were formed and each group was assigned a project that

Intervention Effects on Foster Preschoolers’ Attachment-Related Behaviors From a Randomized Trial

PubMed Central

Fisher, Philip A.; Kim, Hyoun K.

2008-01-01

This study examines change in attachment-related behaviors among foster preschoolers participating in a randomized trial of the Multidimensional Treatment Foster Care Program for Preschoolers (MTFC-P). Measures of secure, resistant, and avoidant behaviors were collected using a caregiver-report diary at 3-month intervals during the 12 months following a new foster placement. Children randomly assigned to the MTFC-P intervention condition (n = 57) showed significant increases in secure behavior and significant decreases in avoidant behavior relative to children assigned to a regular foster care condition (n = 60). Both groups showed significant decreases in resistant behavior over time. Analyses also revealed a significant interaction between treatment condition and age at first foster placement on change in secure behavior. Results are discussed in terms of the importance of early intervention and prevention services for foster preschoolers. PMID:17340186

Constructing cardiovascular fitness knowledge in physical education

PubMed Central

Zhang, Tan; Chen, Ang; Chen, Senlin; Hong, Deockki; Loflin, Jerry; Ennis, Catherine

2015-01-01

In physical education, it has become necessary for children to learn kinesiological knowledge for understanding the benefits of physical activity and developing a physically active lifestyle. This study was conducted to determine the extent to which cognitive assignments about healthful living and fitness contributed to knowledge growth on cardiorespiratory fitness and health. Fourth grade students (N = 616) from 15 randomly sampled urban elementary schools completed 34 cognitive assignments related to the cardiorespiratory physical activities they were engaged in across 10 lessons. Performance on the assignments were analyzed in relation to their knowledge gain measured using a standardized knowledge test. A multivariate discriminant analysis revealed that the cognitive assignments contributed to knowledge gain but the contribution varied assignment by assignment. A multiple regression analysis indicated that students’ assignment performance by lesson contributed positively to their knowledge growth scores. A content analysis based on the constructivist learning framework showed that observing–reasoning assignments contributed the most to knowledge growth. Analytical and analytical–application assignments contributed less than the constructivist theories would predict. PMID:25995702

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

ERIC Educational Resources Information Center

Bertram, Christiane; Wagner, Wolfgang; Trautwein, Ulrich

2017-01-01

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

Effects of Teaching a Library Usage Unit to Seventh Graders.

ERIC Educational Resources Information Center

Gifford, Vernon; Gifford, Jean

This document reports the results of a study undertaken to determine if teaching a 2-week unit on library usage to 7th graders would increase their use of the library. From three non-ability grouped 7th grade classes, two classes of 26 students each were randomly selected for the study. One class was randomly assigned as the experimental group and…

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…

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,…

A random walk rule for phase I clinical trials.

PubMed

Durham, S D; Flournoy, N; Rosenberger, W F

1997-06-01

We describe a family of random walk rules for the sequential allocation of dose levels to patients in a dose-response study, or phase I clinical trial. Patients are sequentially assigned the next higher, same, or next lower dose level according to some probability distribution, which may be determined by ethical considerations as well as the patient's response. It is shown that one can choose these probabilities in order to center dose level assignments unimodally around any target quantile of interest. Estimation of the quantile is discussed; the maximum likelihood estimator and its variance are derived under a two-parameter logistic distribution, and the maximum likelihood estimator is compared with other nonparametric estimators. Random walk rules have clear advantages: they are simple to implement, and finite and asymptotic distribution theory is completely worked out. For a specific random walk rule, we compute finite and asymptotic properties and give examples of its use in planning studies. Having the finite distribution theory available and tractable obviates the need for elaborate simulation studies to analyze the properties of the design. The small sample properties of our rule, as determined by exact theory, compare favorably to those of the continual reassessment method, determined by simulation.

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

PubMed

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

2009-09-01

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

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…

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

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

PubMed

Nash, Kyle; McGregor, Ian; Prentice, Mike

2011-12-01

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

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

ERIC Educational Resources Information Center

Lohr, Sharon L.; Zhu, Xiaoshu

2017-01-01

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

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

ERIC Educational Resources Information Center

Hapkiewicz, Walter G.; Stone, Robert D.

1974-01-01

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

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

ERIC Educational Resources Information Center

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

2010-01-01

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

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

PubMed Central

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

2015-01-01

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

Housing First improves subjective quality of life among homeless adults with mental illness: 12-month findings from a randomized controlled trial in Vancouver, British Columbia.

PubMed

Patterson, Michelle; Moniruzzaman, Akm; Palepu, Anita; Zabkiewicz, Denise; Frankish, Charles J; Krausz, Michael; Somers, Julian M

2013-08-01

This study used an experimental design to examine longitudinal changes in subjective quality of life (QoL) among homeless adults with mental illness after assignment to different types of supported housing or to treatment as usual (TAU, no housing or supports through the study). We hypothesized that subjective QoL would improve over time among participants assigned to supported housing as compared to TAU, regardless of the type of supported housing received or participants' level of need. Participants (n = 497) were stratified by level of need ("high" or "moderate") and randomly assigned to Housing First (HF) in scattered-site apartments, HF in a congregate setting (high needs only), or TAU. Linear mixed-effects regression was used to model the association between study arm and self-reported QoL at baseline and at 6 and 12 months post-baseline by need level. Based on the adjusted overall score on the QoL measure, participants randomized to HF reported significantly greater overall QoL as compared to TAU, regardless of need level or type of supported housing at both 6 and 12 months post-baseline. Scores on the safety and living situation subscales were significantly greater for both high and moderate need participants assigned to supported housing regardless of type at both 6 and 12 months post-baseline as compared to TAU. Despite multiple health and social challenges faced by homeless individuals with mental illness, HF in both scattered-site and congregate models results in significantly greater perceived QoL as compared to individuals who do not receive HF even after a relatively short period of time.

Robin Hood Effects on Motivation in Math: Family Interest Moderates the Effects of Relevance Interventions

ERIC Educational Resources Information Center

Häfner, Isabelle; Flunger, Barbara; Dicke, Anna-Lena; Gaspard, Hanna; Brisson, Brigitte M.; Nagengast, Benjamin; Trautwein, Ulrich

2017-01-01

Using a cluster randomized field trial, the present study tested whether 2 relevance interventions affected students' value beliefs, self-concept, and effort in math differently depending on family background (socioeconomic status, family interest (FI), and parental utility value). Eighty-two classrooms were randomly assigned to either 1 of 2…

A Cognitive Strategy Instruction to Improve Math Calculation for Children with ADHD and LD: A Randomized Controlled Study

ERIC Educational Resources Information Center

Iseman, Jackie S.; Naglieri, Jack A.

2011-01-01

The authors examined the effectiveness of cognitive strategy instruction based on PASS (Planning, Attention, Simultaneous, Successive) given by special education teachers to students with ADHD randomly assigned by classroom. Students in the experimental group were exposed to a brief cognitive strategy instruction for 10 days, which was designed to…

A Randomized Trial of Long-Term Reinforcement of Cocaine Abstinence in Methadone-Maintained Patients Who Inject Drugs

ERIC Educational Resources Information Center

Silverman, Kenneth; Robles, Elias; Mudric, Timothy; Bigelow, George E.; Stitzer, Maxine L.

2004-01-01

This study determined whether long-term abstinence reinforcement could maintain cocaine abstinence throughout a yearlong period. Patients who injected drugs and used cocaine during methadone treatment (n = 78) were randomly assigned to 1 of 2 abstinence-reinforcement groups or to a usual care control group. Participants in the 2…

A Qualitative Examination of Yoga for Middle School Adolescents

ERIC Educational Resources Information Center

Butzer, Bethany; LoRusso, Amanda Marie; Windsor, Regina; Riley, Frankye; Frame, Kate; Khalsa, Sat Bir S.; Conboy, Lisa

2017-01-01

The present study was part of a group randomized controlled trial in which 7th grade students were assigned to a yoga intervention or physical-education-as-usual. Sixteen students were randomly selected from the yoga condition to participate in one-on-one interviews. Qualitative analyses revealed 13 themes that were organized into two categories:…

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…

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

ERIC Educational Resources Information Center

Lerner, Matthew D.; Mikami, Amori Y.

2012-01-01

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

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

ERIC Educational Resources Information Center

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

2013-01-01

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

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.…

Efficacy of a Universal Parent Training Program (HOPE-20): Cluster Randomized Controlled Trial

ERIC Educational Resources Information Center

Leung, Cynthia; Tsang, Sandra; Kwan, H. W.

2017-01-01

Objective: This study examined the efficacy of Hands-On Parent Empowerment-20 (HOPE-20) program. Methods: Eligible participants were parents residing in Hong Kong with target children aged 2 years attending nursery schools. Cluster randomized control trial was adopted, with 10 schools (110 participants) assigned to intervention group and 8 schools…

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

ERIC Educational Resources Information Center

What Works Clearinghouse, 2013

2013-01-01

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

Testing the Efficacy of a Kindergarten Mathematics Intervention by Small Group Size

ERIC Educational Resources Information Center

Clarke, Ben; Doabler, Christian T.; Kosty, Derek; Kurtz Nelson, Evangeline; Smolkowski, Keith; Fien, Hank; Turtura, Jessica

2017-01-01

This study used a randomized controlled trial design to investigate the ROOTS curriculum, a 50-lesson kindergarten mathematics intervention. Ten ROOTS-eligible students per classroom (n = 60) were randomly assigned to one of three conditions: a ROOTS five-student group, a ROOTS two-student group, and a no-treatment control group. Two primary…

Randomized Trial of Three Child/Parent Training Groups for ADHD Children.

ERIC Educational Resources Information Center

Reddy, Linda; Braunstein, Dania; Springer, Craig; Bartik, Celina; Hauch, Yvonne; Hall, Tara; Benisz, Becky; Gioia, Lauren

The present study examined the effectiveness of a multimodal intervention for young children with ADHD. Fifty families were randomly assigned to three treatment conditions: (1) child group training only (N=18); (2) child and parent group training only (N=14); and (3) child and parent group training and parent/teacher consultation (N=18). Child,…

An assessment of re-randomization methods in bark beetle (Scolytidae) trapping bioassays

Treesearch

Christopher J. Fettig; Christopher P. Dabney; Stepehen R. McKelvey; Robert R. Borys

2006-01-01

Numerous studies have explored the role of semiochemicals in the behavior of bark beetles (Scolytidae). Multiple funnel traps are often used to elucidate these behavioral responses. Sufficient sample sizes are obtained by using large numbers of traps to which treatments are randomly assigned once, or by frequent collection of trap catches and subsequent re-...

Which is your choice for prolonging the analgesic duration of single-shot interscalene brachial blocks for arthroscopic shoulder surgery? intravenous dexamethasone 5 mg vs. perineural dexamethasone 5 mg randomized, controlled, clinical trial.

PubMed

Chun, Eun Hee; Kim, Youn Jin; Woo, Jae Hee

2016-06-01

The aim of this study was to compare the effect of intravenous (I.V.) dexamethasone with that of perineural dexamethasone on the prolongation of analgesic duration of single-shot interscalene brachial plexus blocks (SISB) in patients undergoing arthroscopic shoulder surgery. We performed a prospective, randomized, double-blind, placebo-controlled study. Patients undergoing elective arthroscopic shoulder surgery with ultrasound-guided SISB were enrolled and randomized into 2 groups. A total volume of 12 mL of the study drug was prepared with a final concentration of 0.5% ropivacaine. In the I.V. group, patients received SISB using ropivacaine 5 mg mL with normal saline (control) with dexamethasone 5 mg I.V. injection. In the perineural group, patients received SISB using ropivacaine 5 mg mL with dexamethasone 5 mg, with normal saline 1 mL I.V. injection. The primary outcome was the time to the first analgesic request, defined as the time between the end of the operation and the first request of analgesics by the patient. The secondary outcomes included patient satisfaction scores, side effects, and neurological symptoms. Patients were randomly assigned to 1 of the 2 groups using a computer-generated randomization table. An anesthesiologist blinded to the group assignments prepared the solutions for injection. The patients and the investigator participating in the study were also blinded to the group assignments. One hundred patients were randomized. Data were analyzed for 99 patients. One case in the I.V. group was converted to open surgery and was therefore not included in the study. Perineural dexamethasone significantly prolonged analgesic duration (median, standard error: 1080 minutes, 117.5 minutes) compared with I.V. dexamethasone (810 minutes, 48.1 minutes) (P = 0.02). There were no significant differences in side effects, neurological symptoms, or changes in blood glucose values between the 2 groups. Our results show that perineural dexamethasone 5 mg is more effective than I.V. dexamethasone 5 mg with regard to analgesic duration of SISB for arthroscopic shoulder surgery.

Sequenced treatment alternatives to relieve depression (STAR*D): rationale and design.

PubMed

Rush, A John; Fava, Maurizio; Wisniewski, Stephen R; Lavori, Philip W; Trivedi, Madhukar H; Sackeim, Harold A; Thase, Michael E; Nierenberg, Andrew A; Quitkin, Frederic M; Kashner, T Michael; Kupfer, David J; Rosenbaum, Jerrold F; Alpert, Jonathan; Stewart, Jonathan W; McGrath, Patrick J; Biggs, Melanie M; Shores-Wilson, Kathy; Lebowitz, Barry D; Ritz, Louise; Niederehe, George

2004-02-01

STAR*D is a multisite, prospective, randomized, multistep clinical trial of outpatients with nonpsychotic major depressive disorder. The study compares various treatment options for those who do not attain a satisfactory response with citalopram, a selective serotonin reuptake inhibitor antidepressant. The study enrolls 4000 adults (ages 18-75) from both primary and specialty care practices who have not had either a prior inadequate response or clear-cut intolerance to a robust trial of protocol treatments during the current major depressive episode. After receiving citalopram (level 1), participants without sufficient symptomatic benefit are eligible for randomization to level 2 treatments, which entail four switch options (sertraline, bupropion, venlafaxine, cognitive therapy) and three citalopram augment options (bupropion, buspirone, cognitive therapy). Those who receive cognitive therapy (switch or augment options) at level 2 without sufficient improvement are eligible for randomization to one of two level 2A switch options (venlafaxine or bupropion). Level 2 and 2A participants are eligible for random assignment to two switch options (mirtazapine or nortriptyline) and to two augment options (lithium or thyroid hormone) added to the primary antidepressant (citalopram, bupropion, sertraline, or venlafaxine) (level 3). Those without sufficient improvement at level 3 are eligible for level 4 random assignment to one of two switch options (tranylcypromine or the combination of mirtazapine and venlafaxine). The primary outcome is the clinician-rated, 17-item Hamilton Rating Scale for Depression, administered at entry and exit from each treatment level through telephone interviews by assessors masked to treatment assignments. Secondary outcomes include self-reported depressive symptoms, physical and mental function, side-effect burden, client satisfaction, and health care utilization and cost. Participants with an adequate symptomatic response may enter the 12-month naturalistic follow-up phase with brief monthly and more complete quarterly assessments.

HIV Salvage Therapy Does Not Require Nucleoside Reverse Transcriptase Inhibitors: A Randomized, Controlled Trial.

PubMed

Tashima, Karen T; Smeaton, Laura M; Fichtenbaum, Carl J; Andrade, Adriana; Eron, Joseph J; Gandhi, Rajesh T; Johnson, Victoria A; Klingman, Karin L; Ritz, Justin; Hodder, Sally; Santana, Jorge L; Wilkin, Timothy; Haubrich, Richard H

2015-12-15

Nucleoside reverse transcriptase inhibitors (NRTIs) are often included in antiretroviral regimens in treatment-experienced patients in the absence of data from randomized trials. To compare treatment success between participants who omit versus those who add NRTIs to an optimized antiretroviral regimen of 3 or more agents. Multicenter, randomized, controlled trial. (ClinicalTrials.gov: NCT00537394). Outpatient HIV clinics. Treatment-experienced patients with HIV infection and viral resistance. Open-label optimized regimens (not including NRTIs) were selected on the basis of treatment history and susceptibility testing. Participants were randomly assigned to omit or add NRTIs. The primary efficacy outcome was regimen failure through 48 weeks using a noninferiority margin of 15%. The primary safety outcome was time to initial episode of a severe sign, symptom, or laboratory abnormality before discontinuation of NRTI assignment. 360 participants were randomly assigned, and 93% completed a 48-week visit. The cumulative probability of regimen failure was 29.8% in the omit-NRTIs group versus 25.9% in the add-NRTIs group (difference, 3.2 percentage points [95% CI, -6.1 to 12.5 percentage points]). No significant between-group differences were found in the primary safety end points or the proportion of participants with HIV RNA level less than 50 copies/mL. No deaths occurred in the omit-NRTIs group compared with 7 deaths in the add-NRTIs group. Unblinded study design, and the study may not be applicable to resource-poor settings. Treatment-experienced patients with HIV infection starting a new optimized regimen can safely omit NRTIs without compromising virologic efficacy. Omitting NRTIs will reduce pill burden, cost, and toxicity in this patient population. National Institute of Allergy and Infectious Diseases, Boehringer Ingelheim, Janssen, Merck, ViiV Healthcare, Roche, and Monogram Biosciences (LabCorp).

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).

Influence of study goals on study design and execution.

PubMed

Kirklin, J W; Blackstone, E H; Naftel, D C; Turner, M E

1997-12-01

From the viewpoint of a clinician who makes recommendations to patients about choosing from the multiple possible management schemes, quantitative information derived from statistical analyses of observational studies is useful. Although random assignment of therapy is optimal, appropriately performed studies in which therapy has been nonrandomly "assigned" are considered acceptable, albeit occasionally with limitations in inferences. The analyses are considered most useful when they generate multivariable equations suitable for predicting time-related outcomes in individual patients. Graphic presentations improve communication with patients and facilitate truly informed consent.

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.

Anxiety and Health-Related Quality of Life Among Patients With Low–Tumor Burden Non-Hodgkin Lymphoma Randomly Assigned to Two Different Rituximab Dosing Regimens: Results From ECOG Trial E4402 (RESORT)

PubMed Central

Wagner, Lynne I.; Zhao, Fengmin; Hong, Fangxin; Williams, Michael E.; Gascoyne, Randy D.; Krauss, John C.; Advani, Ranjana H.; Go, Ronald S.; Habermann, Thomas M.; Leach, Joseph W.; O'Connor, Brian; Schuster, Stephen J.; Cella, David; Horning, Sandra J.; Kahl, Brad S.

2015-01-01

Purpose The purpose of this study was to compare illness-related anxiety among participants in the Rituximab Extended Schedule or Retreatment Trial (RESORT) randomly assigned to maintenance rituximab (MR) versus rituximab re-treatment (RR). A secondary objective was to examine whether the superiority of MR versus RR on anxiety depended on illness-related coping style. Patients and Methods Patients (N = 253) completed patient-reported outcome (PRO) measures at random assignment to MR or RR (baseline); at 3, 6, 12, 24, 36, and 48 months after random assignment; and at rituximab failure. PRO measures assessed illness-related anxiety and coping style, and secondary end points including general anxiety, worry and interference with emotional well-being, depression, and health-related quality of life (HRQoL). Patients were classified as using an active or avoidant illness-related coping style. Independent sample t tests and linear mixed-effects models were used to identify treatment arm differences on PRO end points and differences based on coping style. Results Illness-related anxiety was comparable between treatment arms at all time points (P > .05), regardless of coping style (active or avoidant). Illness-related anxiety and general anxiety significantly decreased over time on both arms. HRQoL scores were relatively stable and did not change significantly from baseline for both arms. An avoidant coping style was associated with significantly higher anxiety (18% and 13% exceeded clinical cutoff points at baseline and 6 months, respectively) and poorer HRQoL compared with an active coping style (P < .001), regardless of treatment arm assignment. Conclusion Surveillance until RR at progression was not associated with increased anxiety compared with MR, regardless of coping style. Avoidant coping was associated with higher anxiety and poorer HRQoL. PMID:25605841

Enhancing learning using questions, adjunct to science charts

NASA Astrophysics Data System (ADS)

Holliday, William G.; Benson, Garth

This study supported two hypotheses. First, adjunct questions interacted with a science chart so powerfully that content established as difficult to learn in the pilot and in this study's control groups became easier to learn when charted. Second, students familiar with the chart test before instruction (test exposure) were better prepared to take this test after instruction. This adjunct-question study examined the generalizability of selective-attention and academic-studying hypotheses to a modified science chart medium. About 300 high school students were randomly assigned to four conditions each including a vitamin chart (chart only, test exposure, importance of questions emphasized to students by teachers, and combinational conditions - test exposure and question importance) across 16 biology classrooms. Then these same students were again randomly assigned within each classroom to a control and to four question treatments no questions, questions focusing on easy-to-learn charted content, questions focusing on difficult-to-learn charted content, and a combinational treatment.

Enhancing learning using questions adjunct to science charts

NASA Astrophysics Data System (ADS)

Holliday, William G.; Benson, Garth

This study supported two hypotheses. First, adjunct questions interacted with a science chart so powerfully that content established as difficult to learn in the pilot and in this study's control groups became easier to learn when charted. Second, students familiar with the chart test before instruction (test exposure) were better prepared to take this test after instruction. This adjunct-question study examined the generalizability of selective-attention and academic-studying hypotheses to a modified science chart medium. About 300 high school students were randomly assigned to four conditions each including a vitamin chart (chart only, test exposure, importance of questions emphasized to students by teachers, and combinational conditions--test exposure and question importance) across 16 biology classrooms. Then these same students were again randomly assigned within each classroom to a control and to four question treatments (no questions, questions focusing on easy-to-learn charted content, questions focusing on difficult-to-learn charted content, and a combinational treatment).

The Impact of Classroom Physical Activity Breaks on Middle School Students' Health-Related Fitness: An Xbox One Kinetic Delivered 4-Week Randomized Controlled Trial

ERIC Educational Resources Information Center

Yli-Piipari, S.; Layne, T.; McCollins, T.; Knox, T.

2016-01-01

The aim of the study was to examine the effect of a 4-week classroom physical activity break intervention on middle school students' health-related physical fitness. The study was a randomized controlled trial with students assigned to the experiment and control conditions. A convenience sample comprised 94 adolescents (experiment group n = 52;…

A Randomized Double-Blind Study of Atomoxetine versus Placebo for Attention-Deficit/Hyperactivity Disorder Symptoms in Children with Autism Spectrum Disorder

ERIC Educational Resources Information Center

Harfterkamp, Myriam; van de Loo-Neus, Gigi; Minderaa, Ruud B.; van der Gaag, Rutger-Jan; Escobar, Rodrigo; Schacht, Alexander; Pamulapati, Sireesha; Buitelaar, Jan K.; Hoekstra, Pieter J.

2012-01-01

Objective: The efficacy of atomoxetine as treatment of symptoms of attention-deficit/hyperactivity disorder (ADHD) in patients with autism spectrum disorder (ASD) has not been established. Method: In this study, 97 patients aged 6 to 17 years with ADHD and ASD were randomly assigned to double-blind treatment with 1.2 mg/kg/day atomoxetine or…

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.

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

PubMed Central

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

2012-01-01

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

Optimizing the LSST Dither Pattern for Survey Uniformity

NASA Astrophysics Data System (ADS)

Awan, Humna; Gawiser, Eric J.; Kurczynski, Peter; Carroll, Christopher M.; LSST Dark Energy Science Collaboration

2015-01-01

The Large Synoptic Survey Telescope (LSST) will gather detailed data of the southern sky, enabling unprecedented study of Baryonic Acoustic Oscillations, which are an important probe of dark energy. These studies require a survey with highly uniform depth, and we aim to find an observation strategy that optimizes this uniformity. We have shown that in the absence of dithering (large telescope-pointing offsets), the LSST survey will vary significantly in depth. Hence, we implemented various dithering strategies, including random and repulsive random pointing offsets and spiral patterns with the spiral reaching completion in either a few months or the entire ten-year run. We employed three different implementations of dithering strategies: a single offset assigned to all fields observed on each night, offsets assigned to each field independently whenever the field is observed, and offsets assigned to each field only when the field is observed on a new night. Our analysis reveals that large dithers are crucial to guarantee survey uniformity and that assigning dithers to each field independently whenever the field is observed significantly increases this uniformity. These results suggest paths towards an optimal observation strategy that will enable LSST to achieve its science goals.We gratefully acknowledge support from the National Science Foundation REU program at Rutgers, PHY-1263280, and the Department of Energy, DE-SC0011636.

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

ERIC Educational Resources Information Center

Carrell, Scott E.; West, James E.

2008-01-01

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

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

ERIC Educational Resources Information Center

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

2010-01-01

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

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

ERIC Educational Resources Information Center

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

2008-01-01

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

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

ERIC Educational Resources Information Center

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

2017-01-01

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

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

PubMed Central

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

2014-01-01

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

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.).

Effects of diet on carcass quality and consumer taste panel acceptance of intact or castrated hair lambs

USDA-ARS?s Scientific Manuscript database

Forty hair-type lambs were examined in a 70-d study to determine the effects of gender (castrate; C vs. intact; I) and forage type on carcass traits and sensory acceptability. Lambs were procured from a single source in Missouri and one-half were randomly castrated. Lambs were randomly assigned to t...

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.…

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

ERIC Educational Resources Information Center

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

2017-01-01

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

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…

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…

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…

Stress Management-Augmented Behavioral Weight Loss Intervention for African American Women: A Pilot, Randomized Controlled Trial

ERIC Educational Resources Information Center

Cox, Tiffany L.; Krukowski, Rebecca; Love, ShaRhonda J.; Eddings, Kenya; DiCarlo, Marisha; Chang, Jason Y.; Prewitt, T. Elaine; West, Delia Smith

2013-01-01

The relationship between chronic stress and weight management efforts may be a concern for African American (AA) women, who have a high prevalence of obesity, high stress levels, and modest response to obesity treatment. This pilot study randomly assigned 44 overweight/obese AA women with moderate to high stress levels to either a 12-week…

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

ERIC Educational Resources Information Center

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

2012-01-01

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

Acceptance and Commitment Therapy and Cognitive-Behavioral Therapy as Treatments for Academic Procrastination: A Randomized Controlled Group Session

ERIC Educational Resources Information Center

Wang, Shuo; Zhou, Ya; Yu, Shi; Ran, Li-Wen; Liu, Xiang-Ping; Chen, Yu-Fei

2017-01-01

Objective: This study tested the efficacy of Acceptance and Commitment Therapy (ACT), compared with Cognitive-Behavioral Therapy (CBT), in alleviating academic procrastination. Method: A total of 60 (53.3% male) undergraduates suffering from academic procrastination were randomly assigned to two treatment groups (ACT and CBT) and a control group.…

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…

Stepped and Standard Care for Childhood Trauma: A Pilot Randomized Clinical Trial

ERIC Educational Resources Information Center

Salloum, Alison; Small, Brent J.; Robst, John; Scheeringa, Michael S.; Cohen, Judith A.; Storch, Eric A.

2017-01-01

Objective: This study explored the feasibility of stepped care trauma-focused cognitive behavioral therapy (SC-TF-CBT) relative to TF-CBT with children (aged 8--12). Method: Children (N = 33) with post-traumatic stress symptoms (PTSS) were randomly assigned (2:1) to SC-TF-CBT or TF-CBT. SC-TF-CBT consisted of Step 1, parent-led therapist-assisted…

Hypnotic Taper with or without Self-Help Treatment of Insomnia: A Randomized Clinical Trial

ERIC Educational Resources Information Center

Belleville, Genevieve; Guay, Catherine; Guay, Bernard; Morin, Charles M.

2007-01-01

This study aimed to assess the efficacy of a minimal intervention focusing on hypnotic discontinuation and cognitive-behavioral treatment (CBT) for insomnia. Fifty-three adult chronic users of hypnotics were randomly assigned to an 8-week hypnotic taper program, used alone or combined with a self-help CBT. Weekly hypnotic use decreased in both…

The Effect of Herrmann Whole Brain Teaching Method on Students' Understanding of Simple Electric Circuits

ERIC Educational Resources Information Center

Bawaneh, Ali Khalid Ali; Nurulazam Md Zain, Ahmad; Salmiza, Saleh

2011-01-01

The purpose of this study was to investigate the effect of Herrmann Whole Brain Teaching Method over conventional teaching method on eight graders in their understanding of simple electric circuits in Jordan. Participants (N = 273 students; M = 139, F = 134) were randomly selected from Bani Kenanah region-North of Jordan and randomly assigned to…

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 Body Image and Disordered Eating Intervention for Women in Midlife: A Randomized Controlled Trial

ERIC Educational Resources Information Center

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

2011-01-01

Objective: This study examined the outcome of a body image and disordered eating intervention for midlife women. The intervention was specifically designed to address risk factors that are pertinent in midlife. Method: Participants were 61 women aged 30 to 60 years (M = 43.92, SD = 8.22) randomly assigned to intervention (n = 32) or (delayed…

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

ERIC Educational Resources Information Center

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

2013-01-01

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

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…

Efficacy of Creative Clay Work for Reducing Negative Mood: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Kimport, Elizabeth R.; Robbins, Steven J.

2012-01-01

Clay work has long been used in art therapy to achieve therapeutic goals. However, little empirical evidence exists to document the efficacy of such work. The present study randomly assigned 102 adult participants to one of four conditions following induction of a negative mood: (a) handling clay with instructions to create a pinch pot, (b)…

Effects of Animation on Naming and Identification across Two Graphic Symbol Sets Representing Verbs and Prepositions

ERIC Educational Resources Information Center

Schlosser, Ralf W.; Koul, Rajinder; Shane, Howard; Sorce, James; Brock, Kristofer; Harmon, Ashley; Moerlein, Dorothy; Hearn, Emilia

2014-01-01

Purpose: The effects of animation on naming and identification of graphic symbols for verbs and prepositions were studied in 2 graphic symbol sets in preschoolers. Method: Using a 2 × 2 × 2 × 3 completely randomized block design, preschoolers across three age groups were randomly assigned to combinations of symbol set (Autism Language Program…

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

PubMed

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

2018-01-30

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

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

PubMed Central

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

2018-01-01

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

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

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

Fatigue during breast cancer radiotherapy: an initial randomized study of cognitive-behavioral therapy plus hypnosis.

PubMed

Montgomery, Guy H; Kangas, Maria; David, Daniel; Hallquist, Michael N; Green, Sheryl; Bovbjerg, Dana H; Schnur, Julie B

2009-05-01

The study purpose was to test the effectiveness of a psychological intervention combining cognitive-behavioral therapy and hypnosis (CBTH) to treat radiotherapy-related fatigue. Women (n = 42) scheduled for breast cancer radiotherapy were randomly assigned to receive standard medical care (SMC) (n = 20) or a CBTH intervention (n = 22) in addition to SMC. Participants assigned to receive CBTH met individually with a clinical psychologist. CBTH participants received training in hypnosis and CBT. Participants assigned to the SMC control condition did not meet with a study psychologist. Fatigue was measured on a weekly basis by using the fatigue subscale of the Functional Assessment of Chronic Illness Therapy (FACIT) and daily using visual analogue scales. Multilevel modeling indicated that for weekly FACIT fatigue data, there was a significant effect of the CBTH intervention on the rate of change in fatigue (p < .05), such that on average, CBTH participants' fatigue did not increase over the course of treatment, whereas control group participants' fatigue increased linearly. Daily data corroborated the analyses of weekly data. The results suggest that CBTH is an effective means for controlling and potentially preventing fatigue in breast cancer radiotherapy patients.

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

PubMed

Williams, C L; Tappen, R M

2008-01-01

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

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

ERIC Educational Resources Information Center

Rothstein, Jesse

2009-01-01

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

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

ERIC Educational Resources Information Center

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

2013-01-01

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

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

ERIC Educational Resources Information Center

Garcia-Villamisar, Domingo; Dattilo, John

2011-01-01

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

Relapse of Graves' disease after successful outcome of antithyroid drug therapy: results of a prospective randomized study on the use of levothyroxine.

PubMed

Hoermann, Rudolf; Quadbeck, Beate; Roggenbuck, Ulla; Szabolcs, István; Pfeilschifter, Johannes; Meng, Wieland; Reschke, Kirsten; Hackenberg, Klaus; Dettmann, Juergen; Prehn, Brigitte; Hirche, Herbert; Mann, Klaus

2002-12-01

Antithyroid drugs are effective in restoring euthyroidism in Graves' disease, but many patients experience relapse after withdrawal. Prevention of recurrence would therefore be a desirable goal. In a prospective study, patients with successful outcome of 12 to 15 months antithyroid drug therapy were stratified for risk factors and randomly assigned to receive levothyroxine in a variable thyrotropin (TSH)-suppressive dose for 2 years or no treatment. The levothyroxine group was randomized to continue or discontinue levothyroxine after 1 year. End points included relapse of overt hyperthyroidism. Of 346 patients with Graves' disease enrolled 225 were euthyroid 4 weeks after antithyroid drug withdrawal and were randomly assigned to receive levothyroxine (114 patients) or no treatment (controls, 111 patients). Of those not randomized, 39 patients showed early relapse within 4 weeks, 61 endogenous TSH suppression, 7 TSH elevation, and 14 had to be excluded. Dropout rate during the study were 13.3%. Kaplan-Meier analyses showed relapse rates to be similar in the levothyroxine group (20% after 1 year, 32% after 2 years) and the randomized controls (18%, 24%), whereas relapses were significantly more frequent in the follow-up group of patients with endogenously suppressed TSH (33%, 49%). Levothyroxine therapy did not influence TSH-receptor antibody, nor did it reduce goiter size. The best prognostic marker available was basal TSH determined 4 weeks after withdrawal of antithyroid drugs (posttreatment TSH). The study demonstrates that levothyroxine does not prevent relapse of hyperthyroidism after successful restoration of euthyroid function by antithyroid drugs and characterizes posttreatment TSH as a main prognostic marker.

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

PubMed

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

2017-08-01

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

Clinical Trials in Vision Research

MedlinePlus

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

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.

Cluster-randomized xylitol toothpaste trial for early childhood caries prevention.

PubMed

Chi, Donald L; Tut, Ohnmar; Milgrom, Peter

2014-01-01

The purpose of this study was to assess the efficacy of supervised tooth-brushing with xylitol toothpaste to prevent early childhood caries (ECC) and reduce mutans streptococci. In this cluster-randomized efficacy trial, 196 four- to five-year-old children in four Head Start classrooms in the Marshall Islands were randomly assigned to supervised toothbrushing with 1,400 ppm/31 percent fluoride xylitol or 1,450 ppm fluoride sorbitol toothpaste. We hypothesized that there would be no difference in efficacy between the two types of toothpaste. The primary outcome was the surface-level primary molar caries increment (d(2-3)mfs) after six months. A single examiner was blinded to classroom assignments. Two classrooms were assigned to the fluoride-xylitol group (85 children), and two classrooms were assigned to the fluoride-sorbitol group (83 children). The child-level analyses accounted for clustering. There was no difference between the two groups in baseline or end-of-trial mean d(2-3)mfs. The mean d(2-3)mfs increment was greater in the fluoride-xylitol group compared to the fluoride-sorbitol group (2.5 and 1.4 d(2-3)mfs, respectively), but the difference was not significant (95% confidence interval: -0.17, 2.37; P=.07). No adverse effects were reported. After six months, brushing with a low-strength xylitol/fluoride tooth-paste is no more efficacious in reducing ECC than a fluoride-only toothpaste in a high caries-risk child population.

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

PubMed

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

2014-11-01

The evidence of suicide prevention training for nurses is scarce. Strategies to enhance general nurses' ability in suicide risk assessment are critical to develop effective training programs in general medical settings. This study was aimed to examine the effectiveness of an interactive discussion group in a suicide prevention training program for general nurses. In this randomized study with two groups of pre-post study design, the sample was recruited from the Medical, Surgical, and Emergency/Intensive Care Sectors of a 2000-bed general hospital via stratified randomization. Among the 111 nurses, 57 participants randomly assigned to the control group received a two-hour baseline suicide gatekeeper lecture, and 54 participants assigning to the experimental group received an additional five-hour group discussion about suicide risk assessment skills. Using a case vignette, the nurses discussed and assessed suicide risk factors specified in a 10-item Chinese SAD PERSONS Scale during a group discussion intervention. The findings revealed that the nurses achieved significant and consistent improvements of risk identification and assessment after the intervention without influencing their mental health status for assessing suicide risks. The result suggested an effective approach of interactive group discussion for facilitating critical thinking and learning suicide risk assessment skills among general nurses. Copyright © 2014 Elsevier Ltd. All rights reserved.

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...

Acceptability of randomization to levonorgestrel versus copper intrauterine device among women requesting IUD insertion for contraception

PubMed Central

Achilles, Sharon L.; Chen, Beatrice A.; Lee, Jessica K.; Gariepy, Aileen M.; Creinin, Mitchell D.

2015-01-01

Objective Assess feasibility of randomizing women to intrauterine device (IUD) type. Study Design Women enrolling in a 2-month study who desired an IUD for contraception were randomized 1:1 to receive a levonorgestrel 52mg IUD (LNG-IUD) or copper T380A (Cu-IUD), understanding they could switch IUD type at the end of the study. Results Randomization to IUD type was acceptable to 54/55 (98%) women who screened. All 32 enrolled participants completed follow-up. Two women exchanged their IUD (Cu-IUD to LNG-IUD) and 2 requested removal (1 LNG-IUD, 1 Cu-IUD). Overall, 88% continued their assigned IUD. Conclusions Randomization to IUD type is feasible and few women change their IUD. PMID:26297203

Cardiopulmonary resuscitation by chest compression alone or with mouth-to-mouth ventilation.

PubMed

Hallstrom, A; Cobb, L; Johnson, E; Copass, M

2000-05-25

Despite extensive training of citizens of Seattle in cardiopulmonary resuscitation (CPR), bystanders do not perform CPR in almost half of witnessed cardiac arrests. Instructions in chest compression plus mouth-to-mouth ventilation given by dispatchers over the telephone can require 2.4 minutes. In experimental studies, chest compression alone is associated with survival rates similar to those with chest compression plus mouth-to-mouth ventilation. We conducted a randomized study to compare CPR by chest compression alone with CPR by chest compression plus mouth-to-mouth ventilation. The setting of the trial was an urban, fire-department-based, emergency-medical-care system with central dispatching. In a randomized manner, telephone dispatchers gave bystanders at the scene of apparent cardiac arrest instructions in either chest compression alone or chest compression plus mouth-to-mouth ventilation. The primary end point was survival to hospital discharge. Data were analyzed for 241 patients randomly assigned to receive chest compression alone and 279 assigned to chest compression plus mouth-to-mouth ventilation. Complete instructions were delivered in 62 percent of episodes for the group receiving chest compression plus mouth-to-mouth ventilation and 81 percent of episodes for the group receiving chest compression alone (P=0.005). Instructions for compression required 1.4 minutes less to complete than instructions for compression plus mouth-to-mouth ventilation. Survival to hospital discharge was better among patients assigned to chest compression alone than among those assigned to chest compression plus mouth-to-mouth ventilation (14.6 percent vs. 10.4 percent), but the difference was not statistically significant (P=0.18). The outcome after CPR with chest compression alone is similar to that after chest compression with mouth-to-mouth ventilation, and chest compression alone may be the preferred approach for bystanders inexperienced in CPR.

A randomized controlled trial of contingency management for psycho-stimulant use in community mental health outpatients with co-occurring serious mental illness

PubMed Central

McDonell, Michael G.; Srebnik, Debra; Angelo, Frank; McPherson, Sterling; Lowe, Jessica M.; Sugar, Andrea; Short, Robert A.; Roll, John M.; Ries, Richard K.

2014-01-01

Objective The primary objective of this study was to determine if contingency management was associated with increased stimulant drug abstinence in community mental health outpatients with serious mental illness and stimulant dependence. Secondary objectives were to determine if contingency management was associated with reductions in use of other substances, psychiatric symptoms, HIV-risk behavior, and inpatient service utilization. Method A randomized controlled design compared outcomes of 176 outpatients with serious mental illness and stimulant dependence. Participants were randomized to three months of contingency management for stimulant abstinence plus treatment-as-usual or treatment-as-usual with reinforcement for study participation only. Urine drug tests, self-report, clinician-report, and service utilization outcomes were assessed during three-month treatment and three-month follow-up periods. Results While participants in the contingency management condition were less likely to complete the treatment period (n=38; 42%) than those assigned to the control condition (n=55; 65%), X2(1)=9.8, p=0.02; those assigned to the contingency management condition were 2.4 (CI=1.9-3.0) times more likely to submit a stimulant-negative urine test during treatment. Participants assigned to contingency management experienced significantly lower levels of alcohol use, injection drug use, psychiatric symptoms, and were five times less likely than those assigned to the control condition to be admitted for psychiatric hospitalization, X2(1)=5.4, p=0.02. Contingency management participants reported significantly fewer days of stimulant drug use, relative to controls during the three-month follow-up. Conclusions When added to treatment-as-usual, contingency management is associated with large reductions in stimulant, injection drug, and alcohol use. Reductions in psychiatric symptoms and hospitalizations were important secondary benefits. PMID:23138961

The Demand for, and Impact of, Learning HIV Status

PubMed Central

Thornton, Rebecca L.

2011-01-01

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

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

Code of Federal Regulations, 2013 CFR

2013-10-01

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

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

Code of Federal Regulations, 2014 CFR

2014-10-01

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

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

Code of Federal Regulations, 2012 CFR

2012-10-01

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

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

Code of Federal Regulations, 2012 CFR

2012-10-01

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

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

Code of Federal Regulations, 2013 CFR

2013-10-01

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

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

Code of Federal Regulations, 2014 CFR

2014-10-01

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

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

ERIC Educational Resources Information Center

Wagler, Amy; Wagler, Ron

2014-01-01

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

The Relative Effects and Equity of Inquiry-Based and Commonplace Science Teaching on Students' Knowledge, Reasoning, and Argumentation

ERIC Educational Resources Information Center

Wilson, Christopher D.; Taylor, Joseph A.; Kowalski, Susan M.; Carlson, Janet

2010-01-01

We conducted a laboratory-based randomized control study to examine the effectiveness of inquiry-based instruction. We also disaggregated the data by student demographic variables to examine if inquiry can provide equitable opportunities to learn. Fifty-eight students aged 14-16 years old were randomly assigned to one of two groups. Both groups of…

Muscle Strength Enhancement Following Home-Based Virtual Cycling Training in Ambulatory Children with Cerebral Palsy

ERIC Educational Resources Information Center

Chen, Chia-Ling; Hong, Wei-Hsien; Cheng, Hsin-Yi Kathy; Liaw, Mei-Yun; Chung, Chia-Ying; Chen, Chung-Yao

2012-01-01

This study is the first well-designed randomized controlled trial to assess the effects of a novel home-based virtual cycling training (hVCT) program for improving muscle strength in children with spastic cerebral palsy (CP). Twenty-eight ambulatory children with spastic CP aged 6-12 years were randomly assigned to an hVCT group (n = 13) or a…

N-Acetylcysteine in the Treatment of Pediatric Trichotillomania: A Randomized, Double-Blind, Placebo-Controlled Add-On Trial

ERIC Educational Resources Information Center

Bloch, Michael H.; Panza, Kaitlyn E.; Grant, Jon E.; Pittenger, Christopher; Leckman, James F.

2013-01-01

Objective: To examine the efficacy of N-acetylcysteine (NAC) for the treatment of pediatric trichotillomania (TTM) in a double-blind, placebo-controlled, add-on study. Method: A total of 39 children and adolescents aged 8 to 17 years with pediatric trichotillomania were randomly assigned to receive NAC or matching placebo for 12 weeks. Our primary…

Effects of a Randomized Couple-Based Intervention on Quality of Life of Breast Cancer Patients and Their Partners

ERIC Educational Resources Information Center

Kayser, Karen; Feldman, Barry N.; Borstelmann, Nancy A.; Daniels, Ann A.

2010-01-01

The purpose of this study was to determine the effectiveness of a couple-based intervention on the quality of life (QOL) of early-stage breast cancer patients and their partners. A randomized controlled design was used to assign couples to either the hospital standard social work services (SSWS) or a couple-based intervention, the Partners in…

A Randomized Trial of Cognitive Behaviour Therapy and Cognitive Therapy for Children with Posttraumatic Stress Disorder following Single-Incident Trauma

ERIC Educational Resources Information Center

Nixon, Reginald David Vandervord; Sterk, Jisca; Pearce, Amanda

2012-01-01

The present study compared the efficacy of trauma-focused cognitive behavior therapy (CBT) with trauma-focused cognitive therapy (without exposure; CT) for children and youth with posttraumatic stress disorder (PTSD). Children and youth who had experienced single-incident trauma (N = 33; 7-17 years old) were randomly assigned to receive 9 weeks of…

Primary Prevention of Parent-Child Conflict and Abuse in Iranian Mothers: A Randomized-Controlled Trial

ERIC Educational Resources Information Center

Oveisi, Sonia; Ardabili, Hassan Eftekhare; Dadds, Mark R.; Majdzadeh, Reza; Mohammadkhani, Parvaneh; Rad, Javad Alaqband; Shahrivar, Zahra

2010-01-01

Objective: The aim of this study was to assess whether primary health care settings can be used to engage and provide a preventive intervention to mothers of young children. Methods: Two hundred and twenty-four mothers who had come to the health centers were randomly assigned to either control group (CG: n=116) or intervention group (IG: n = 108).…

The Impacts of a Scalable Intervention on the Language and Literacy Development of Rural Pre-Kindergartners

ERIC Educational Resources Information Center

Mashburn, Andrew; Justice, Laura M.; McGinty, Anita; Slocum, Laura

2016-01-01

Read It Again (RIA) is a curriculum for pre-kindergarten (pre-K) classrooms that targets children's development of language and literacy skills. A cluster randomized trial was conducted in which 104 pre-K classrooms in the Appalachian region of the United States were randomly assigned to one of three study conditions: Control (n = 30), RIA only…

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

ERIC Educational Resources Information Center

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

2014-01-01

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

A Randomized Controlled Trial 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…

Does Mailing a Post Card to Students Improve Response Rates? Issue Brief

ERIC Educational Resources Information Center

Moore, Raeal; Earnhart, Benjamin

2017-01-01

A random sample of students who took the ACT test in either April or June of 2016 were invited to participate in an online survey via an email invitation (N = 35,0471). To study whether mailing post card invitations to students improves response rates, a portion of these test-takers were randomly assigned to be sent a post card. In addition,…

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.…

School-Based Prevention of Depressive Symptoms: A Randomized Controlled Study of the Effectiveness and Specificity of the Penn Resiliency Program

ERIC Educational Resources Information Center

Gillham, Jane E.; Reivich, Karen J.; Freres, Derek R.; Chaplin, Tara M.; Shatte, Andrew J.; Samuels, Barbra; Elkon, Andrea G. L.; Litzinger, Samantha; Lascher, Marisa; Gallop, Robert; Seligman, Martin E. P.

2007-01-01

The authors investigated the effectiveness and specificity of the Penn Resiliency Program (PRP; J. E. Gillham, L. H. Jaycox, K. J. Reivich, M. E. P. Seligman, & T. Silver, 1990), a cognitive-behavioral depression prevention program. Children (N = 697) from 3 middle schools were randomly assigned to PRP, Control (CON), or the Penn Enhancement …

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…

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

ERIC Educational Resources Information Center

What Works Clearinghouse, 2012

2012-01-01

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

Some practical problems in implementing randomization.

PubMed

Downs, Matt; Tucker, Kathryn; Christ-Schmidt, Heidi; Wittes, Janet

2010-06-01

While often theoretically simple, implementing randomization to treatment in a masked, but confirmable, fashion can prove difficult in practice. At least three categories of problems occur in randomization: (1) bad judgment in the choice of method, (2) design and programming errors in implementing the method, and (3) human error during the conduct of the trial. This article focuses on these latter two types of errors, dealing operationally with what can go wrong after trial designers have selected the allocation method. We offer several case studies and corresponding recommendations for lessening the frequency of problems in allocating treatment or for mitigating the consequences of errors. Recommendations include: (1) reviewing the randomization schedule before starting a trial, (2) being especially cautious of systems that use on-demand random number generators, (3) drafting unambiguous randomization specifications, (4) performing thorough testing before entering a randomization system into production, (5) maintaining a dataset that captures the values investigators used to randomize participants, thereby allowing the process of treatment allocation to be reproduced and verified, (6) resisting the urge to correct errors that occur in individual treatment assignments, (7) preventing inadvertent unmasking to treatment assignments in kit allocations, and (8) checking a sample of study drug kits to allow detection of errors in drug packaging and labeling. Although we performed a literature search of documented randomization errors, the examples that we provide and the resultant recommendations are based largely on our own experience in industry-sponsored clinical trials. We do not know how representative our experience is or how common errors of the type we have seen occur. Our experience underscores the importance of verifying the integrity of the treatment allocation process before and during a trial. Clinical Trials 2010; 7: 235-245. http://ctj.sagepub.com.

Being "SMART" About Adolescent Conduct Problems Prevention: Executing a SMART Pilot Study in a Juvenile Diversion Agency.

PubMed

August, Gerald J; Piehler, Timothy F; Bloomquist, Michael L

2016-01-01

The development of adaptive treatment strategies (ATS) represents the next step in innovating conduct problems prevention programs within a juvenile diversion context. Toward this goal, we present the theoretical rationale, associated methods, and anticipated challenges for a feasibility pilot study in preparation for implementing a full-scale SMART (i.e., sequential, multiple assignment, randomized trial) for conduct problems prevention. The role of a SMART design in constructing ATS is presented. The SMART feasibility pilot study includes a sample of 100 youth (13-17 years of age) identified by law enforcement as early stage offenders and referred for precourt juvenile diversion programming. Prior data on the sample population detail a high level of ethnic diversity and approximately equal representations of both genders. Within the SMART, youth and their families are first randomly assigned to one of two different brief-type evidence-based prevention programs, featuring parent-focused behavioral management or youth-focused strengths-building components. Youth who do not respond sufficiently to brief first-stage programming will be randomly assigned a second time to either an extended parent- or youth-focused second-stage programming. Measures of proximal intervention response and measures of potential candidate tailoring variables for developing ATS within this sample are detailed. Results of the described pilot study will include information regarding feasibility and acceptability of the SMART design. This information will be used to refine a subsequent full-scale SMART. The use of a SMART to develop ATS for prevention will increase the efficiency and effectiveness of prevention programing for youth with developing conduct problems.

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

PubMed Central

Thompson, Sam

2013-01-01

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

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

PubMed

Kjell, Oscar N E; Thompson, Sam

2013-12-19

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

Priming Ability Emotional Intelligence

ERIC Educational Resources Information Center

Schutte, Nicola S.; Malouff, John M.

2012-01-01

Two studies examined whether priming self-schemas relating to successful emotional competency results in better emotional intelligence performance. In the first study participants were randomly assigned to a successful emotional competency self-schema prime condition or a control condition and then completed an ability measure of emotional…

Improving Reading Comprehension and Social Studies Knowledge in Middle School

ERIC Educational Resources Information Center

Vaughn, Sharon; Swanson, Elizabeth A.; Roberts, Greg; Wanzek, Jeanne; Stillman-Spisak, Stephanie J.; Solis, Michael; Simmons, Deborah

2013-01-01

This study aimed to determine the efficacy of a content acquisition and reading comprehension treatment implemented by eighth-grade social studies teachers. Using a within-teacher design, the eighth-grade teachers' social studies classes were randomly assigned to treatment or comparison conditions. Teachers (n = 5) taught the same instructional…

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

PubMed

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

2017-11-23

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

A multicenter, randomized, controlled trial of osteopathic manipulative treatment on preterms.

PubMed

Cerritelli, Francesco; Pizzolorusso, Gianfranco; Renzetti, Cinzia; Cozzolino, Vincenzo; D'Orazio, Marianna; Lupacchini, Mariacristina; Marinelli, Benedetta; Accorsi, Alessandro; Lucci, Chiara; Lancellotti, Jenny; Ballabio, Silvia; Castelli, Carola; Molteni, Daniela; Besana, Roberto; Tubaldi, Lucia; Perri, Francesco Paolo; Fusilli, Paola; D'Incecco, Carmine; Barlafante, Gina

2015-01-01

Despite some preliminary evidence, it is still largely unknown whether osteopathic manipulative treatment improves preterm clinical outcomes. The present multi-center randomized single blind parallel group clinical trial enrolled newborns who met the criteria for gestational age between 29 and 37 weeks, without any congenital complication from 3 different public neonatal intensive care units. Preterm infants were randomly assigned to usual prenatal care (control group) or osteopathic manipulative treatment (study group). The primary outcome was the mean difference in length of hospital stay between groups. A total of 695 newborns were randomly assigned to either the study group (n= 352) or the control group (n=343). A statistical significant difference was observed between the two groups for the primary outcome (13.8 and 17.5 days for the study and control group respectively, p<0.001, effect size: 0.31). Multivariate analysis showed a reduction of the length of stay of 3.9 days (95% CI -5.5 to -2.3, p<0.001). Furthermore, there were significant reductions with treatment as compared to usual care in cost (difference between study and control group: 1,586.01€; 95% CI 1,087.18 to 6,277.28; p<0.001) but not in daily weight gain. There were no complications associated to the intervention. Osteopathic treatment reduced significantly the number of days of hospitalization and is cost-effective on a large cohort of preterm infants.

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

Health, nutrition and prosperity: a microeconomic perspective.

PubMed Central

Thomas, Duncan; Frankenberg, Elizabeth

2002-01-01

A positive correlation between health and economic prosperity has been widely documented, but the extent to which this reflects a causal effect of health on economic outcomes is very controversial. Two classes of evidence are examined. First, carefully designed random assignment studies in the laboratory and field provide compelling evidence that nutritional deficiency - particularly iron deficiency - reduces work capacity and, in some cases, work output. Confidence in these results is bolstered by a good understanding of the underlying biological mechanisms. Some random assignment studies indicate an improved yield from health services in the labour market. Second, observational studies suggest that general markers of nutritional status, such as height and body mass index (BMI), are significant predictors of economic success although their interpretation is confounded by the fact that they reflect influences from early childhood and family background. Energy intake and possibly the quality of the diet have also been found to be predictive of economic success in observational studies. However, the identification of causal pathways in these studies is difficult and involves statistical assumptions about unobserved heterogeneity that are difficult to test. Illustrations using survey data demonstrate the practical importance of this concern. Furthermore, failure to take into account the dynamic interplay between changes in health and economic status has led to limited progress being reported in the literature. A broadening of random assignment studies to measure the effects of an intervention on economic prosperity, investment in population-based longitudinal socioeconomic surveys, and application of emerging technologies for a better measure of health in these surveys will yield very high returns in improving our understanding of how health influences economic prosperity. PMID:11953788

Exploring the Use of Podcasts and Vodcasts: Multimedia Tools for Word Learning

PubMed Central

Lowman, Joneen

2016-01-01

The study investigated the impact of podcasts and vodcasts accessed through an iPod on fourth- and sixth-grade students’ vocabulary acquisition. Students were randomly assigned to either a podcast group or a vodcast group. Regardless of group assignment, each student completed three six-minute podcasts or vodcasts a day for three days. On average, students learned four out of nine words taught regardless of group assignment. The vodcast group learned significantly more words compared to the podcast group at the receptive level and at the expressive level. Student comments indicated that iPods should be used to teach and to review words. PMID:27840555

Contact replacement for NMR resonance assignment.

PubMed

Xiong, Fei; Pandurangan, Gopal; Bailey-Kellogg, Chris

2008-07-01

Complementing its traditional role in structural studies of proteins, nuclear magnetic resonance (NMR) spectroscopy is playing an increasingly important role in functional studies. NMR dynamics experiments characterize motions involved in target recognition, ligand binding, etc., while NMR chemical shift perturbation experiments identify and localize protein-protein and protein-ligand interactions. The key bottleneck in these studies is to determine the backbone resonance assignment, which allows spectral peaks to be mapped to specific atoms. This article develops a novel approach to address that bottleneck, exploiting an available X-ray structure or homology model to assign the entire backbone from a set of relatively fast and cheap NMR experiments. We formulate contact replacement for resonance assignment as the problem of computing correspondences between a contact graph representing the structure and an NMR graph representing the data; the NMR graph is a significantly corrupted, ambiguous version of the contact graph. We first show that by combining connectivity and amino acid type information, and exploiting the random structure of the noise, one can provably determine unique correspondences in polynomial time with high probability, even in the presence of significant noise (a constant number of noisy edges per vertex). We then detail an efficient randomized algorithm and show that, over a variety of experimental and synthetic datasets, it is robust to typical levels of structural variation (1-2 AA), noise (250-600%) and missings (10-40%). Our algorithm achieves very good overall assignment accuracy, above 80% in alpha-helices, 70% in beta-sheets and 60% in loop regions. Our contact replacement algorithm is implemented in platform-independent Python code. The software can be freely obtained for academic use by request from the authors.

Reducing Dropout in Treatment for Depression: Translating Dropout Predictors Into Individualized Treatment Recommendations.

PubMed

Zilcha-Mano, Sigal; Keefe, John R; Chui, Harold; Rubin, Avinadav; Barrett, Marna S; Barber, Jacques P

2016-12-01

Premature discontinuation of therapy is a widespread problem that hampers the delivery of mental health treatment. A high degree of variability has been found among rates of premature treatment discontinuation, suggesting that rates may differ depending on potential moderators. In the current study, our aim was to identify demographic and interpersonal variables that moderate the association between treatment assignment and dropout. Data from a randomized controlled trial conducted from November 2001 through June 2007 (N = 156) comparing supportive-expressive therapy, antidepressant medication, and placebo for the treatment of depression (based on DSM-IV criteria) were used. Twenty prerandomization variables were chosen based on previous literature. These variables were subjected to exploratory bootstrapped variable selection and included in the logistic regression models if they passed variable selection. Three variables were found to moderate the association between treatment assignment and dropout: age, pretreatment therapeutic alliance expectations, and the presence of vindictive tendencies in interpersonal relationships. When patients were divided into those randomly assigned to their optimal treatment and those assigned to their least optimal treatment, dropout rates in the optimal treatment group (24.4%) were significantly lower than those in the least optimal treatment group (47.4%; P = .03). Present findings suggest that a patient's age and pretreatment interpersonal characteristics predict the association between common depression treatments and dropout rate. If validated by further studies, these characteristics can assist in reducing dropout through targeted treatment assignment. Secondary analysis of data from ClinicalTrials.gov identifier: NCT00043550. © Copyright 2016 Physicians Postgraduate Press, Inc.

77 FR 8878 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-15

.... Participants have been randomly assigned to either a Head Start group or a control group. Data collection for... of 4,667 treatment and control group members in the Head Start Impact Study, minus 432 families that...

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

PubMed

Morawska, Alina; Sanders, Matthew R

2007-05-01

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

Student-peer mentoring on a drug information response.

PubMed

Rodis, Jennifer Lin; Backo, Jennifer; Schmidt, Brittany M; Pruchnicki, Maria C

2014-03-12

To implement a student peer-mentoring program with a drug information response assignment in an introductory pharmacy practice course. Second-year student pharmacists (P2 mentors) enrolled in an independent study course were randomly assigned first-year student pharmacists (P1 mentees) to mentor on a drug information assignment. The P2 mentors provided feedback to P1 mentees' assignment drafts. The P1 mentees had the opportunity to revise the draft prior to turning in the completed assignment to course faculty members for grading. Both P1 mentees and P2 mentors agreed the mentorship improved their ability to prepare a drug information response (76% and 100%, respectively). A majority of the student pharmacists would choose to be involved in the program again. The student peer-mentoring program was successful in improving student pharmacists' perceptions of ability to compose a drug information response.

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.

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…

Alcohol assessment among college students using wireless mobile technology.

PubMed

Bernhardt, Jay M; Usdan, Stuart; Mays, Darren; Martin, Ryan; Cremeens, Jennifer; Arriola, Kimberly Jacob

2009-09-01

This study used a two-group randomized design to assess the validity of measuring self-reported alcohol consumption among college students using the Handheld Assisted Network Diary (HAND), a daily diary assessment administered using wireless mobile devices. A convenience sample of college students was recruited at a large, public university in the southeastern United States and randomized into two groups. A randomly assigned group of 86 students completed the daily HAND assessment during the 30-day study and a Timeline Followback (TLFB) at 30-day follow-up. A randomly assigned group of 82 students completed the paper-and-pencil Daily Social Diary (DSD) over the same study period. Data from the daily HAND assessment were compared with the TLFB completed at follow-up by participants who completed the HAND using 95% limits of agreement analysis. Furthermore, individual growth models were used to examine differences between the HAND and DSD by comparing the total drinks, drinking days, and drinks per drinking day captured by the two assessments over the study period. Results suggest that the HAND captured similar levels of alcohol use compared with the TLFB completed at follow-up by the same participants. In addition, comparisons of the two study groups suggest that, controlling for baseline alcohol use and demographics, the HAND assessment captured similar levels of total drinks, drinking days, and drinks per drinking day as the paper-and-pencil DSD. The study findings support the validity of wireless mobile devices as a daily assessment of alcohol use among college students.

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

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

PubMed

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

2017-01-01

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

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

PubMed Central

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

1999-01-01

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

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.

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

PubMed

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

2009-12-01

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

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…

Determining the Effects That the Order of Abstraction and Type of Reflection Have on Content Knowledge When Teaching Experientially: An Exploratory Experiment

ERIC Educational Resources Information Center

Baker, Marshall A.; Brown, Nicholas R.; Blackburn, J. Joey; Robinson, J. Shane

2014-01-01

The purpose of this experimental study was to determine the effects of order of abstraction and type of reflection on student knowledge acquisition. Students were assigned randomly to one of four treatment combinations in the completely randomized 2 x 2 design which included either abstraction prior to or directly after an experience, and either…

The Impact of Supplemental Handwriting and Spelling Instruction with First Grade Students Who Do Not Acquire Transcription Skills as Rapidly as Peers: A Randomized Control Trial

ERIC Educational Resources Information Center

Graham, Steve; Harris, Karen R.; Adkins, Mary

2018-01-01

The impact of supplemental handwriting and spelling instruction on learning to write was examined in an experimental study with first grade students who were not acquiring these skills as rapidly as their classmates. Thirty students (16 boys, 14 girls) were randomly assigned to a handwriting and spelling instructional condition or a phonological…

The Effects of Total Physical Response by Storytelling and the Traditional Teaching Styles of a Foreign Language in a Selected High School

ERIC Educational Resources Information Center

Kariuki, Patrick N. K.; Bush, Elizabeth Danielle

2008-01-01

The purpose of this study was to examine the effects of Total Physical Response by Storytelling and the traditional teaching method on a foreign language in a selected high school. The sample consisted of 30 students who were randomly selected and randomly assigned to experimental and control group. The experimental group was taught using Total…

Water-Based Aerobic Training Successfully Improves Lipid Profile of Dyslipidemic Women: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Costa, Rochelle Rocha; Pilla, Carmen; Buttelli, Adriana Cristine Koch; Barreto, Michelle Flores; Vieiro, Priscila Azevedo; Alberton, Cristine Lima; Bracht, Cláudia Gomes; Kruel, Luiz Fernando Martins

2018-01-01

Purpose: This study aimed to investigate the effects of water-based aerobic training on the lipid profile and lipoprotein lipase (LPL) levels in premenopausal women with dyslipidemia. Method: Forty women were randomly assigned to: aquatic training (WA; n = 20) or a control group (CG; n = 20). The WA group underwent 12 weeks of water-based interval…

Enhancing the Interpretive Reading and Analytical Writing of Mainstreamed English Learners in Secondary School: Results from a Randomized Field Trial Using a Cognitive Strategies Approach

ERIC Educational Resources Information Center

Olson, Carol Booth; Kim, James S.; Scarcella, Robin; Kramer, Jason; Pearson, Matthew; van Dyk, David A.; Collins, Penny; Land, Robert E.

2012-01-01

In this study, 72 secondary English teachers from the Santa Ana Unified School District were randomly assigned to participate in the Pathway Project, a cognitive strategies approach to teaching interpretive reading and analytical writing, or to a control condition involving typical district training focusing on teaching content from the textbook.…

The Effectiveness of Conflict Maps and the V-Shape Teaching Method in Science Conceptual Change among Eighth-Grade Students in Jordan

ERIC Educational Resources Information Center

Bawaneh, Ali Khalid Ali; Zain, Ahmad Nurulazam Md; Ghazali, Munirah

2010-01-01

The purpose of the present study is to investigate the effectiveness of Conflict Maps and the V-Shape method as teaching methods in bringing about conceptual change in science among primary eighth-grade students in Jordan. A randomly selected sample (N = 63) from the Bani Kenana region North of Jordan was randomly assigned to the two teaching…

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

Randomized Multicenter Trial of the Effects of Melanoma-Associated Helper Peptides and Cyclophosphamide on the Immunogenicity of a Multipeptide Melanoma Vaccine

PubMed Central

Slingluff, Craig L.; Petroni, Gina R.; Chianese-Bullock, Kimberly A.; Smolkin, Mark E.; Ross, Merrick I.; Haas, Naomi B.; von Mehren, Margaret; Grosh, William W.

2011-01-01

Purpose This multicenter randomized trial was designed to test whether melanoma-associated helper peptides augment CD8+ T-cell responses to a melanoma vaccine and whether cyclophosphamide (CY) pretreatment augments CD4+ or CD8+ T-cell responses to that vaccine. Patients and Methods In all, 167 eligible patients with resected stage IIB to IV melanoma were randomly assigned to four vaccination study arms. Patients were vaccinated with 12 class I major histocompatibility complex–restricted melanoma peptides (12MP) to stimulate CD8+ T cells and were randomly assigned to receive a tetanus helper peptide or a mixture of six melanoma-associated helper peptides (6MHP) to stimulate CD4+ T cells. Before vaccination, patients were also randomly assigned to receive CY pretreatment or not. T-cell responses were assessed by an ex vivo interferon gamma ELISpot assay. Clinical outcomes and toxicities were recorded. Results Vaccination with 12MP plus tetanus induced CD8+ T-cell responses in 78% of patients and CD4+ T-cell responses to tetanus peptide in 93% of patients. Vaccination with 12MP plus 6MHP induced CD8+ responses in 19% of patients and CD4+ responses to 6MHP in 48% of patients. CY had no significant effect on T-cell responses. Overall 3-year survival was 79% (95% CI, 71% to 86%), with no significant differences (at this point) by study arm. Conclusion Melanoma-associated helper peptides paradoxically decreased CD8+ T-cell responses to a melanoma vaccine (P < .001), and CY pretreatment had no immunologic or clinical effect. Prior work showed immunologic and clinical activity of 6MHP alone. Possible explanations for negative effects on CD8 responses include modulation of homing receptor expression or induction of antigen-specific regulatory T cells. PMID:21690475

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

PubMed

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

2012-12-01

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

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.

A minimal-contact intervention for cardiac inpatients: long-term effects on smoking cessation.

PubMed

Bolman, Catherine; de Vries, Hein; van Breukelen, Gerard

2002-08-01

This study examined the 1-year effects of a minimal-contact smoking cessation intervention for cardiac inpatients. The multicenter study included cardiac inpatients who had smoked prior to hospitalization. A pretest-posttest quasi-experimental design was used. Patients' experimental condition depended on the hospital they were assigned to. The design was partially randomized: 4 of the 11 hospitals selected the experimental condition themselves (2 experimental, 2 control), while the remaining 7 hospitals were randomly assigned. The experimental group consisted of patients of 5 hospitals (N = 388). Patients of 6 other hospitals served as the control group (N = 401). The intervention included stop-smoking advice by the cardiologist, brief counseling by the nurse, the provision of self-help materials, and aftercare by the cardiologist. Logistic regression analyses controlling for baseline differences and covariates did not show significant intervention effects on point prevalence and continuous abstinence. The study also showed that the outcomes were not significantly related to the way hospitals were assigned to the experimental condition. While short-term effects were found, the minimal-contact intervention did not result in significant effects after 12 months, at least if patients lost to follow-up were treated as posttest smokers. Efforts should be made to improve the intervention, especially the aftercare.

Understanding the Effects of Different Study Methods on Retention of Information and Transfer of Learning

ERIC Educational Resources Information Center

Egan, Rylan G.

2012-01-01

Introduction: The following study investigates relationships between spaced practice (re-studying after a delay) and transfer of learning. Specifically, the impact on learners ability to transfer learning after participating in spaced model-building or unstructured study of narrated text. Method: Subjects were randomly assigned either to a…

Use of personalized Dynamic Treatment Regimes (DTRs) and Sequential Multiple Assignment Randomized Trials (SMARTs) in mental health studies

PubMed Central

Liu, Ying; ZENG, Donglin; WANG, Yuanjia

2014-01-01

Summary Dynamic treatment regimens (DTRs) are sequential decision rules tailored at each point where a clinical decision is made based on each patient’s time-varying characteristics and intermediate outcomes observed at earlier points in time. The complexity, patient heterogeneity, and chronicity of mental disorders call for learning optimal DTRs to dynamically adapt treatment to an individual’s response over time. The Sequential Multiple Assignment Randomized Trial (SMARTs) design allows for estimating causal effects of DTRs. Modern statistical tools have been developed to optimize DTRs based on personalized variables and intermediate outcomes using rich data collected from SMARTs; these statistical methods can also be used to recommend tailoring variables for designing future SMART studies. This paper introduces DTRs and SMARTs using two examples in mental health studies, discusses two machine learning methods for estimating optimal DTR from SMARTs data, and demonstrates the performance of the statistical methods using simulated data. PMID:25642116

A randomized placebo-controlled trial of electroencephalographic (EEG) neurofeedback in children with attention-deficit/hyperactivity disorder.

PubMed

van Dongen-Boomsma, Martine; Vollebregt, Madelon A; Slaats-Willemse, Dorine; Buitelaar, Jan K

2013-08-01

A double-blind, randomized, placebo-controlled study was designed to assess the efficacy and safety of electroencephalographic (EEG) neurofeedback in children with attention-deficit/hyperactivity disorder (ADHD). The study started in August 2008 and ended in July 2012 and was conducted at Karakter Child and Adolescent Psychiatry University Centre in Nijmegen, The Netherlands. Forty-one children (aged 8-15 years) with a DSM-IV-TR diagnosis of ADHD were randomly assigned to treatment with either EEG neurofeedback (n = 22) or placebo neurofeedback (n = 19) for 30 sessions, given as 2 sessions per week. The children were stratified by age, electrophysiologic state of arousal, and medication use. Everyone involved in the study, except the neurofeedback therapist and the principal investigator, was blinded to treatment assignment. The primary outcome was severity of ADHD symptoms on the ADHD Rating Scale IV, scored at baseline, during treatment, and at study end. Clinical improvement as measured by the Clinical Global Impressions-Improvement scale (CGI-I) was a secondary outcome. While total ADHD symptoms improved over time in both groups (F1,39 = 26.56, P < .001), there was no significant treatment effect, ie, group × time interaction (F1,39 = 0.36, P = .554); the same was true for clinical improvement as measured by the CGI-I (P = .092). No clinically relevant side effects were observed. Among the children and their parents, guessing treatment assignment was not better than chance level (P = .224 for children, P = .643 for parents). EEG neurofeedback was not superior to placebo neurofeedback in improving ADHD symptoms in children with ADHD. ClinicalTrials.gov identifier: NCT00723684. © Copyright 2013 Physicians Postgraduate Press, Inc.

Being “SMART” about Adolescent Conduct Problems Prevention: Executing a SMART Pilot Study in a Juvenile Diversion Agency

PubMed Central

August, Gerald J.; Piehler, Timothy F.; Bloomquist, Michael L.

2014-01-01

OBJECTIVE The development of adaptive treatment strategies (ATS) represents the next step in innovating conduct problems prevention programs within a juvenile diversion context. Towards this goal, we present the theoretical rationale, associated methods, and anticipated challenges for a feasibility pilot study in preparation for implementing a full-scale SMART (i.e., sequential, multiple assignment, randomized trial) for conduct problems prevention. The role of a SMART design in constructing ATS is presented. METHOD The SMART feasibility pilot study includes a sample of 100 youth (13–17 years of age) identified by law enforcement as early stage offenders and referred for pre-court juvenile diversion programming. Prior data on the sample population detail a high level of ethnic diversity and approximately equal representations of both genders. Within the SMART, youth and their families are first randomly assigned to one of two different brief-type evidence-based prevention programs, featuring parent-focused behavioral management or youth-focused strengths-building components. Youth who do not respond sufficiently to brief first-stage programming will be randomly assigned a second time to either an extended parent- or youth-focused second-stage programming. Measures of proximal intervention response and measures of potential candidate tailoring variables for developing ATS within this sample are detailed. RESULTS Results of the described pilot study will include information regarding feasibility and acceptability of the SMART design. This information will be used to refine a subsequent full-scale SMART. CONCLUSIONS The use of a SMART to develop ATS for prevention will increase the efficiency and effectiveness of prevention programing for youth with developing conduct problems. PMID:25256135

Ecologically-Based Family Therapy Outcome with Substance Abusing Runaway Adolescents

PubMed Central

Slesnick, Natasha; Prestopnik, Jillian L.

2007-01-01

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

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

PubMed Central

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

2012-01-01

Grounded in Person-Environment Fit Theory, this study examined whether low-income mothers' preferences for education moderated the effects of employment- and education-focused welfare programs on children's positive and problem behaviors. The sample included 1,365 families with children between ages 3 and 5 at study entry. Results 5 years after random assignment, when children were ages 8 to 10, indicated that mothers' education preferences did moderate program impacts on teacher-reported child behavior problems and positive behavior. Children whose mothers were assigned to the education program were rated by teachers to have less externalizing behavior and more positive behavior than children whose mothers were assigned to the employment program, but only when mothers had strong preferences for education. PMID:22861169

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

A randomized clinical trial comparing an extended-use hygroscopic condenser humidifier with heated-water humidification in mechanically ventilated patients.

PubMed

Kollef, M H; Shapiro, S D; Boyd, V; Silver, P; Von Harz, B; Trovillion, E; Prentice, D

1998-03-01

To determine the safety and cost-effectiveness of mechanical ventilation with an extended-use hygroscopic condenser humidifier (Duration; Nellcor Puritan-Bennett; Eden Prairie, Minn) compared with mechanical ventilation with heated-water humidification. Prospective randomized clinical trial. Medical and surgical ICUs of Barnes-Jewish Hospital, St. Louis, a university-affiliated teaching hospital. Three hundred ten consecutive qualified patients undergoing mechanical ventilation. Patients requiring mechanical ventilation were randomly assigned to receive humidification with either an extended-use hygroscopic condenser humidifier (for up to the first 7 days of mechanical ventilation) or heated-water humidification. Occurrence of ventilator-associated pneumonia, endotracheal tube occlusion, duration of mechanical ventilation, lengths of intensive care and hospitalization, acquired multiorgan dysfunction, and hospital mortality. One hundred sixty-three patients were randomly assigned to receive humidification with an extended-use hygroscopic condenser humidifier, and 147 patients were randomly assigned to receive heated-water humidification. The two groups were similar at the time of randomization with regard to demographic characteristics, ICU admission diagnoses, and severity of illness. Risk factors for the development of ventilator-associated pneumonia were also similar during the study period for both treatment groups. Ventilator-associated pneumonia was seen in 15 (9.2%) patients receiving humidification with an extended-use hygroscopic condenser humidifier and in 15 (10.2%) patients receiving heated-water humidification (relative risk, 0.90; 95% confidence interval=0.46 to 1.78; p=0.766). No statistically significant differences for hospital mortality, duration of mechanical ventilation, lengths of stay in the hospital ICU, or acquired organ system derangements were found between the two treatment groups. No episode of endotracheal tube occlusion occurred during the study period in either treatment group. The total cost of providing humidification was $2,605 for patients receiving a hygroscopic condenser humidifier compared with $5,625 for patients receiving heated-water humidification. Our findings suggest that the initial application of an extended-use hygroscopic condenser humidifier is a safe and more cost-effective method of providing humidification to patients requiring mechanical ventilation compared with heated-water humidification.

The effects of task and resource interdependence on achievement and social support: an exploratory study of Italian children.

PubMed

Bertucci, Andrea; Johnson, David W; Johnson, Roger T; Conte, Stella

2011-01-01

The relative efficacy of positive task interdependence, positive resource interdependence, and individualistic learning were compared with achievement and academic and personal social support. The authors randomly assigned to conditions 66 7th-grade Italian students with no previous experience in cooperative learning. They participated in 6 90-min instructional sessions dealing with the dangers of smoking, alcohol, and drugs. The results indicated that students assigned to the task-interdependence and resource-interdependence conditions achieved higher and perceived greater peer academic support than did students working individually. Students in the resource-interdependence condition showed a higher perception of peer personal support than students assigned to the other conditions.

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.

Manifestation Determination Decisions and Students with Emotional/Behavioral Disorders

ERIC Educational Resources Information Center

Walker, Jennifer D.; Brigham, Frederick J.

2017-01-01

Sixteen general and special education teachers were randomly assigned to one of four teams that were to make manifestation determinations using two different "hidden profiles" case studies based on students with an emotional behavioral disability. One case study was constructed to support a decision of the behavior not being a…

Instructional Set, Deep Relaxation and Growth Enhancement: A Pilot Study

ERIC Educational Resources Information Center

Leeb, Charles; And Others

1976-01-01

This study provides experimental evidence that instructional set can influence access to altered states of consciousness. Fifteen male subjects were randomly assigned to three groups, each of which received the same autogenic biofeedback training in hand temperature control, but each group received a different attitudinal set. (Editor)

Changing Emotion: The Use of Therapeutic Storytelling

ERIC Educational Resources Information Center

Parker, Trent S.; Wampler, Karen S.

2006-01-01

Even though using metaphors in a therapeutic context is common, there are very few studies that address their effects. This study examines the effects of storytelling in therapy. After discussing a problem in a current relationship, 42 female participants were randomly assigned to receive either a story or psychoeducational information. Results…

Impacts of Dialogical Storybook Reading on Young Children's Reading Attitudes and Vocabulary Development

ERIC Educational Resources Information Center

Kotaman, Huseyin

2013-01-01

The current study assessed the impact of parents' dialogical storybook reading on their children's receptive vocabulary and reading attitudes. Forty parents and their preschoolers participated in the study. Parents were randomly assigned to experimental or control groups. The experimental group received dialogical storybook reading training.…

Experimental Treatment of Early Stuttering: A Preliminary Study

ERIC Educational Resources Information Center

Franken, Marie-Christine J.; Kielstra-Van der Schalk, Carine J.; Boelens, Harrie

2005-01-01

This pilot study compared two treatments for stuttering in preschool-age children. Thirty children were randomly assigned to either a Lidcombe Program (LP) treatment or a Demands and Capacities Model (DCM) treatment. Stuttering frequencies and severity ratings were obtained immediately before and after treatment (12 weeks). The stuttering…

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

ERIC Educational Resources Information Center

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

2014-01-01

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

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…

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

ERIC Educational Resources Information Center

Rhoads, Christopher H.; Dye, Charles

2016-01-01

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

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

PubMed Central

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

2005-01-01

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

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

PubMed

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

2016-06-01

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

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…

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

ERIC Educational Resources Information Center

Livingston, Samuel A.; Kim, Sooyeon

2010-01-01

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

Outcomes from a Randomized Controlled Trial of a Group Intervention for HIV Positive Men and Women Coping with AIDS-Related Loss and Bereavement

ERIC Educational Resources Information Center

Sikkema, Kathleen J.; Hansen, Nathan B.; Kochman, Arlene; Tate, David C.; DiFranceisco, Wayne

2004-01-01

The purpose of this study was to examine the impact of a group coping intervention for HIV-positive men and women who have lost a loved one(s) to AIDS in the past 2 years. Two hundred thirty-five participants, diverse with respect to race/ethnicity and sexual orientation, were randomly assigned to a 12-week cognitive-behavioral group intervention…

Effects of a Physical Education-Based Programme on Health-Related Physical Fitness and Its Maintenance in High School Students: A Cluster-Randomized Controlled Trial

ERIC Educational Resources Information Center

Mayorga-Vega, Daniel; Montoro-Escaño, Jorge; Merino-Marban, Rafael; Viciana, Jesús

2016-01-01

The purpose of this study was to examine the effects of a physical education-based development and maintenance programme on objective and perceived health-related physical fitness in high school students. A sample of 111 students aged 12-14 years old from six classes were cluster-randomly assigned to an experimental group (n = 54) or a control…

Mediating Effects of Home-Related Factors on Fat Intake from Snacks in a School-Based Nutrition Intervention among Adolescents

ERIC Educational Resources Information Center

Van Lippevelde, Wendy; van Stralen, Maartje; Verloigne, Maite; De Bourdeaudhuij, Ilse; Deforche, Benedicte; Brug, Johannes; Maes, Lea; Haerens, Leen

2012-01-01

The purpose of the present study was to investigate if the effects of the parental component of a school-based intervention on dietary fat intake from snacking were mediated by changes in home-related factors. A random sample of 10 schools with 2232 pupils aged 11-15 years was randomly assigned to one of two intervention groups [one with (n =…

Vaccination With Patient-Specific Tumor-Derived Antigen in First Remission Improves Disease-Free Survival in Follicular Lymphoma

PubMed Central

Schuster, Stephen J.; Neelapu, Sattva S.; Gause, Barry L.; Janik, John E.; Muggia, Franco M.; Gockerman, Jon P.; Winter, Jane N.; Flowers, Christopher R.; Nikcevich, Daniel A.; Sotomayor, Eduardo M.; McGaughey, Dean S.; Jaffe, Elaine S.; Chong, Elise A.; Reynolds, Craig W.; Berry, Donald A.; Santos, Carlos F.; Popa, Mihaela A.; McCord, Amy M.; Kwak, Larry W.

2011-01-01

Purpose Vaccination with hybridoma-derived autologous tumor immunoglobulin (Ig) idiotype (Id) conjugated to keyhole limpet hemocyanin (KLH) and administered with granulocyte-monocyte colony-stimulating factor (GM-CSF) induces follicular lymphoma (FL) –specific immune responses. To determine the clinical benefit of this vaccine, we conducted a double-blind multicenter controlled phase III trial. Patients and Methods Treatment-naive patients with advanced stage FL achieving complete response (CR) or CR unconfirmed (CRu) after chemotherapy were randomly assigned two to one to receive either Id vaccine (Id-KLH + GM-CSF) or control (KLH + GM-CSF). Primary efficacy end points were disease-free survival (DFS) for all randomly assigned patients and DFS for randomly assigned patients receiving at least one dose of Id vaccine or control. Results Of 234 patients enrolled, 177 (81%) achieved CR/CRu after chemotherapy and were randomly assigned. For 177 randomly assigned patients, including 60 patients not vaccinated because of relapse (n = 55) or other reasons (n = 5), median DFS between Id-vaccine and control arms was 23.0 versus 20.6 months, respectively (hazard ratio [HR], 0.81; 95% CI, 0.56 to 1.16; P = .256). For 117 patients who received Id vaccine (n = 76) or control (n = 41), median DFS after randomization was 44.2 months for Id-vaccine arm versus 30.6 months for control arm (HR, 0.62; 95% CI, 0.39 to 0.99; P = .047) at median follow-up of 56.6 months (range, 12.6 to 89.3 months). In an unplanned subgroup analysis, median DFS was significantly prolonged for patients receiving IgM-Id (52.9 v 28.7 months; P = .001) but not IgG-Id vaccine (35.1 v 32.4 months; P = .807) compared with isotype-matched control-treated patients. Conclusion Vaccination with patient-specific hybridoma-derived Id vaccine after chemotherapy-induced CR/CRu may prolong DFS in patients with FL. Vaccine isotype may affect clinical outcome and explain differing results between this and other controlled Id-vaccine trials. PMID:21632504

A Multicenter, Randomized, Controlled Trial of Osteopathic Manipulative Treatment on Preterms

PubMed Central

Cerritelli, Francesco; Pizzolorusso, Gianfranco; Renzetti, Cinzia; Cozzolino, Vincenzo; D’Orazio, Marianna; Lupacchini, Mariacristina; Marinelli, Benedetta; Accorsi, Alessandro; Lucci, Chiara; Lancellotti, Jenny; Ballabio, Silvia; Castelli, Carola; Molteni, Daniela; Besana, Roberto; Tubaldi, Lucia; Perri, Francesco Paolo; Fusilli, Paola; D’Incecco, Carmine; Barlafante, Gina

2015-01-01

Background Despite some preliminary evidence, it is still largely unknown whether osteopathic manipulative treatment improves preterm clinical outcomes. Materials and Methods The present multi-center randomized single blind parallel group clinical trial enrolled newborns who met the criteria for gestational age between 29 and 37 weeks, without any congenital complication from 3 different public neonatal intensive care units. Preterm infants were randomly assigned to usual prenatal care (control group) or osteopathic manipulative treatment (study group). The primary outcome was the mean difference in length of hospital stay between groups. Results A total of 695 newborns were randomly assigned to either the study group (n= 352) or the control group (n=343). A statistical significant difference was observed between the two groups for the primary outcome (13.8 and 17.5 days for the study and control group respectively, p<0.001, effect size: 0.31). Multivariate analysis showed a reduction of the length of stay of 3.9 days (95% CI -5.5 to -2.3, p<0.001). Furthermore, there were significant reductions with treatment as compared to usual care in cost (difference between study and control group: 1,586.01€; 95% CI 1,087.18 to 6,277.28; p<0.001) but not in daily weight gain. There were no complications associated to the intervention. Conclusions Osteopathic treatment reduced significantly the number of days of hospitalization and is cost-effective on a large cohort of preterm infants. PMID:25974071

Urn models for response-adaptive randomized designs: a simulation study based on a non-adaptive randomized trial.

PubMed

Ghiglietti, Andrea; Scarale, Maria Giovanna; Miceli, Rosalba; Ieva, Francesca; Mariani, Luigi; Gavazzi, Cecilia; Paganoni, Anna Maria; Edefonti, Valeria

2018-03-22

Recently, response-adaptive designs have been proposed in randomized clinical trials to achieve ethical and/or cost advantages by using sequential accrual information collected during the trial to dynamically update the probabilities of treatment assignments. In this context, urn models-where the probability to assign patients to treatments is interpreted as the proportion of balls of different colors available in a virtual urn-have been used as response-adaptive randomization rules. We propose the use of Randomly Reinforced Urn (RRU) models in a simulation study based on a published randomized clinical trial on the efficacy of home enteral nutrition in cancer patients after major gastrointestinal surgery. We compare results with the RRU design with those previously published with the non-adaptive approach. We also provide a code written with the R software to implement the RRU design in practice. In detail, we simulate 10,000 trials based on the RRU model in three set-ups of different total sample sizes. We report information on the number of patients allocated to the inferior treatment and on the empirical power of the t-test for the treatment coefficient in the ANOVA model. We carry out a sensitivity analysis to assess the effect of different urn compositions. For each sample size, in approximately 75% of the simulation runs, the number of patients allocated to the inferior treatment by the RRU design is lower, as compared to the non-adaptive design. The empirical power of the t-test for the treatment effect is similar in the two designs.

Adolescent Substance Use in the Multimodal Treatment Study of Attention-Deficit/Hyperactivity Disorder (ADHD) (MTA) as a Function of Childhood ADHD, Random Assignment to Childhood Treatments, and Subsequent Medication

PubMed Central

Molina, Brooke S.G.; Hinshaw, Stephen P.; Arnold, L. Eugene; Swanson, James M.; Pelham, William E.; Hechtman, Lily; Hoza, Betsy; Epstein, Jeffery N.; Wigal, Timothy; Abikoff, Howard B.; Greenhill, Laurence L.; Jensen, Peter S.; Wells, Karen C.; Vitiello, Benedetto; Gibbons, Robert D.; Howard, Andrea; Houck, Patricia R.; Hur, Kwan; Lu, Bo; Marcus, Sue

2013-01-01

Objectives To determine long-term effects on substance use and substance use disorder (SUD), up to 8 years after childhood enrollment, of the randomly assigned 14-month treatments in the multisite Multimodal Treatment Study of Children with Attention-Deficit/Hyperactivity Disorder (MTA; n=436); to test whether (a) medication at follow-up, (b) cumulative psychostimulant treatment over time, or (c) both relate to substance use/SUD; to compare substance use/SUD in the ADHD sample to the non-ADHD childhood classmate comparison group (n=261). Method Mixed-effects regression models with planned contrasts were used for all tests except the important cumulative stimulant treatment question, for which propensity score matching analysis was used. Results The originally randomized treatment groups did not differ significantly on substance use/SUD by the 8 year follow-up or earlier (M age = 17 years). Neither medication at follow-up (mostly stimulants) nor cumulative stimulant treatment was associated with adolescent substance use/SUD. Substance use at all time points, including use of two or more substances and SUD, were each greater in the ADHD than non-ADHD samples, regardless of sex. Conclusions Medication for ADHD did not protect from, nor contribute to, visible risk of substance use or SUD by adolescence, whether analyzed as randomized treatment assignment in childhood, as medication at follow-up, or as cumulative stimulant treatment over an 8 year follow-up from childhood. These results suggest the need to identify alternative or adjunctive adolescent-focused approaches to substance abuse prevention and treatment for boys and girls with ADHD, especially given their increased risk for use and abuse of multiple substances that is not improved with stimulant medication. Clinical trial registration information—Multimodal Treatment Study of Children with Attention Deficit and Hyperactivity Disorder (MTA); http://clinical trials.gov/; NCT00000388. PMID:23452682

Adolescent substance use in the multimodal treatment study of attention-deficit/hyperactivity disorder (ADHD) (MTA) as a function of childhood ADHD, random assignment to childhood treatments, and subsequent medication.

PubMed

Molina, Brooke S G; Hinshaw, Stephen P; Eugene Arnold, L; Swanson, James M; Pelham, William E; Hechtman, Lily; Hoza, Betsy; Epstein, Jeffery N; Wigal, Timothy; Abikoff, Howard B; Greenhill, Laurence L; Jensen, Peter S; Wells, Karen C; Vitiello, Benedetto; Gibbons, Robert D; Howard, Andrea; Houck, Patricia R; Hur, Kwan; Lu, Bo; Marcus, Sue

2013-03-01

To determine long-term effects on substance use and substance use disorder (SUD), up to 8 years after childhood enrollment, of the randomly assigned 14-month treatments in the multisite Multimodal Treatment Study of Children with Attention-Deficit/Hyperactivity Disorder (MTA; n = 436); to test whether medication at follow-up, cumulative psychostimulant treatment over time, or both relate to substance use/SUD; and to compare substance use/SUD in the ADHD sample to the non-ADHD childhood classmate comparison group (n = 261). Mixed-effects regression models with planned contrasts were used for all tests except the important cumulative stimulant treatment question, for which propensity score matching analysis was used. The originally randomized treatment groups did not differ significantly on substance use/SUD by the 8-year follow-up or earlier (mean age = 17 years). Neither medication at follow-up (mostly stimulants) nor cumulative stimulant treatment was associated with adolescent substance use/SUD. Substance use at all time points, including use of two or more substances and SUD, were each greater in the ADHD than in the non-ADHD samples, regardless of sex. Medication for ADHD did not protect from, or contribute to, visible risk of substance use or SUD by adolescence, whether analyzed as randomized treatment assignment in childhood, as medication at follow-up, or as cumulative stimulant treatment over an 8-year follow-up from childhood. These results suggest the need to identify alternative or adjunctive adolescent-focused approaches to substance abuse prevention and treatment for boys and girls with ADHD, especially given their increased risk for use and abuse of multiple substances that is not improved with stimulant medication. Clinical trial registration information-Multimodal Treatment Study of Children With Attention Deficit and Hyperactivity Disorder (MTA); http://clinical trials.gov/; NCT00000388. Copyright © 2013 American Academy of Child and Adolescent Psychiatry. All rights reserved.

Environmental influences on young adult weight gain: evidence from a natural experiment.

PubMed

Kapinos, Kandice A; Yakusheva, Olga

2011-01-01

This study investigated the importance of environmental influences in explaining weight gain and related behaviors among freshman college students. We exploited a natural experiment that takes place on most college campuses in the United States--randomized dormitory assignments. We estimated the effects of living in dormitories with varying physical environment characteristics on weight gain and related behaviors (daily number of meals and snacks, weekly frequency of exercise) among randomly assigned freshman students. We found strong evidence linking weight and related behaviors to individual dormitories, as well as to specific characteristics of the dormitories. On average, students assigned to dormitories with on-site dining halls gained more weight and exhibited more behaviors consistent with weight gain during the freshman year as compared with students not assigned to such dormitories. Females in such dormitories weighed .85 kg (p = .03) more and exercised 1.43 (p < .01) times fewer; males consumed .22 (p = .02) more meals and .38 (p = .01) more snacks. For female students, closer proximity of the dormitory to a campus gym led to more frequent exercise (.54, p = .03), whereas living closer to central campus reduced exercise (-.97, p = .01). Using a natural experiment to deal with the potential endogeneity of the living environment, this study found that the physical environment affects both students' weight changes and weight-related behaviors. Copyright © 2011 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

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.

Flexible embedding of networks

NASA Astrophysics Data System (ADS)

Fernandez-Gracia, Juan; Buckee, Caroline; Onnela, Jukka-Pekka

We introduce a model for embedding one network into another, focusing on the case where network A is much bigger than network B. Nodes from network A are assigned to the nodes in network B using an algorithm where we control the extent of localization of node placement in network B using a single parameter. Starting from an unassigned node in network A, called the source node, we first map this node to a randomly chosen node in network B, called the target node. We then assign the neighbors of the source node to the neighborhood of the target node using a random walk based approach. To assign each neighbor of the source node to one of the nodes in network B, we perform a random walk starting from the target node with stopping probability α. We repeat this process until all nodes in network A have been mapped to the nodes of network B. The simplicity of the model allows us to calculate key quantities of interest in closed form. By varying the parameter α, we are able to produce embeddings from very local (α = 1) to very global (α --> 0). We show how our calculations fit the simulated results, and we apply the model to study how social networks are embedded in geography and how the neurons of C. Elegans are embedded in the surrounding volume.

Editorial--Avoiding Unethical Helicobacter pylori Clinical Trials: Susceptibility-Based Studies and Probiotics as Adjuvants.

PubMed

Graham, David Y

2015-10-01

As a general rule, any clinical study where the result is already known or when the investigator(s) compares an assigned treatment against another assigned treatment known to be ineffective in the study population (e.g., in a population with known clarithromycin resistance) is unethical. As susceptibility-based therapy will always be superior to empiric therapy in any population with a prevalence of antimicrobial resistance >0%, any trial that randomizes susceptibility-based therapy with empiric therapy would be unethical. The journal Helicobacter welcomes susceptibility or culture-guided studies, studies of new therapies, and studies of adjuvants and probiotics. However, the journal will not accept for review any study we judge to be lacking clinical equipoise or which assign subjects to a treatment known to be ineffective, such as a susceptibility-based clinical trial with an empiric therapy comparator. To assist authors, we provide examples and suggestions regarding trial design for comparative studies, for susceptibility-based studies, and for studies testing adjuvants or probiotics. © 2015 John Wiley & Sons Ltd.

Advisor-Teller Money Manager (ATM) therapy for substance use disorders.

PubMed

Rosen, Marc I; Rounsaville, Bruce J; Ablondi, Karen; Black, Anne C; Rosenheck, Robert A

2010-07-01

Patients with concomitant psychiatric and substance use disorders are commonly assigned representative payees or case managers to help manage their funds, but money management has not been conceptualized as a theory-based treatment. This randomized clinical trial was conducted to determine the effect of a money management-based therapy, advisor-teller money manager (ATM), on substance abuse or dependence. Ninety patients at a community mental health center who had a history of cocaine or alcohol abuse or dependence were assessed after random assignment to 36 weeks of ATM (N=47) or a control condition in which use of a financial workbook was reviewed (N=43). Patients assigned to ATM were encouraged to deposit their funds into a third-party account, plan weekly expenditures, and negotiate monthly budgets. Substance use calendars and urine toxicology tests were collected every other week for 36 weeks and again 52 weeks after randomization. Patients assigned to ATM had significantly more negative toxicologies for cocaine metabolite over time than patients in the control group, and treating clinicians rated ATM patients as significantly more likely to be abstinent from illicit drugs. Self-reported abstinence from alcohol did not significantly differ between groups. Unexpectedly, patients assigned to ATM were more likely to be assigned a representative payee or a conservator than control participants during the follow-up period (ten of 47 versus two of 43). One patient in ATM assaulted the therapist when his check had not arrived. ATM is an efficacious therapy for the treatment of cocaine abuse or dependence among people with concomitant psychiatric illness but requires protection of patient autonomy and staff safety.

Does Head Start differentially benefit children with risks targeted by the program’s service model?☆

PubMed Central

Miller, Elizabeth B.; Farkas, George; Duncan, Greg J.

2015-01-01

Data from the Head Start Impact Study (N = 3540) were used to test for differential benefits of Head Start after one program year and after kindergarten on pre-academic and behavior outcomes for children at risk in the domains targeted by the program’s comprehensive services. Although random assignment to Head Start produced positive treatment main effects on children’s pre-academic skills and behavior problems, residualized growth models showed that random assignment to Head Start did not differentially benefit the pre-academic skills of children with risk factors targeted by the Head Start service model. The models showed detrimental impacts of Head Start for maternal-reported behavior problems of high-risk children, but slightly more positive impacts for teacher-reported behavior. Policy implications for Head Start are discussed. PMID:26379369

The direct assignment option as a modular design component: an example for the setting of two predefined subgroups.

PubMed

An, Ming-Wen; Lu, Xin; Sargent, Daniel J; Mandrekar, Sumithra J

2015-01-01

A phase II design with an option for direct assignment (stop randomization and assign all patients to experimental treatment based on interim analysis, IA) for a predefined subgroup was previously proposed. Here, we illustrate the modularity of the direct assignment option by applying it to the setting of two predefined subgroups and testing for separate subgroup main effects. We power the 2-subgroup direct assignment option design with 1 IA (DAD-1) to test for separate subgroup main effects, with assessment of power to detect an interaction in a post-hoc test. Simulations assessed the statistical properties of this design compared to the 2-subgroup balanced randomized design with 1 IA, BRD-1. Different response rates for treatment/control in subgroup 1 (0.4/0.2) and in subgroup 2 (0.1/0.2, 0.4/0.2) were considered. The 2-subgroup DAD-1 preserves power and type I error rate compared to the 2-subgroup BRD-1, while exhibiting reasonable power in a post-hoc test for interaction. The direct assignment option is a flexible design component that can be incorporated into broader design frameworks, while maintaining desirable statistical properties, clinical appeal, and logistical simplicity.

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.

Editorial - Avoiding unethical Helicobacter pylori clinical trials: Susceptibility-based studies and probiotics as adjuvants

PubMed Central

Graham, David Y.

2016-01-01

As a general rule, any clinical study where the result is already known or when the investigator(s) compares an assigned treatment against another assigned treatment known to be ineffective in the study population (e.g. in a population with known clarithromycin resistance) is unethical. Since susceptibility-based therapy will always be superior to empiric therapy in any population with a prevalence of antimicrobial resistance greater than 0%, any trial that randomizes susceptibility-based therapy with empiric therapy would be unethical. The journal Helicobacter welcomes susceptibility or culture-guided studies, studies of new therapies and of adjuvants and probiotics. However, the Journal will not accept for review any study we judge to be lacking clinical equipoise or which assign subjects to a treatment known to be ineffective, such as a susceptibility-based clinical trial with an empiric therapy comparator. To assist authors we provide examples and suggestion regarding trial design for comparative studies, for susceptibility-based studies, and for studies testing adjuvants or probiotics. PMID:26123529

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

PubMed

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

2013-04-01

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

Random Assignment: Practical Considerations from Field Experiments.

ERIC Educational Resources Information Center

Dunford, Franklyn W.

1990-01-01

Seven qualitative issues associated with randomization that have the potential to weaken or destroy otherwise sound experimental designs are reviewed and illustrated via actual field experiments. Issue areas include ethics and legality, liability risks, manipulation of randomized outcomes, hidden bias, design intrusiveness, case flow, and…

Comparing Relaxation Programs for Breast Cancer Patients Receiving Radiotherapy

Cancer.gov

In this study, women with breast cancer who have had surgery and are scheduled to undergo radiation therapy will be randomly assigned to one of two different stretching and relaxation programs or to a control group that will receive usual care.

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

An efficient randomized algorithm for contact-based NMR backbone resonance assignment.

PubMed

Kamisetty, Hetunandan; Bailey-Kellogg, Chris; Pandurangan, Gopal

2006-01-15

Backbone resonance assignment is a critical bottleneck in studies of protein structure, dynamics and interactions by nuclear magnetic resonance (NMR) spectroscopy. A minimalist approach to assignment, which we call 'contact-based', seeks to dramatically reduce experimental time and expense by replacing the standard suite of through-bond experiments with the through-space (nuclear Overhauser enhancement spectroscopy, NOESY) experiment. In the contact-based approach, spectral data are represented in a graph with vertices for putative residues (of unknown relation to the primary sequence) and edges for hypothesized NOESY interactions, such that observed spectral peaks could be explained if the residues were 'close enough'. Due to experimental ambiguity, several incorrect edges can be hypothesized for each spectral peak. An assignment is derived by identifying consistent patterns of edges (e.g. for alpha-helices and beta-sheets) within a graph and by mapping the vertices to the primary sequence. The key algorithmic challenge is to be able to uncover these patterns even when they are obscured by significant noise. This paper develops, analyzes and applies a novel algorithm for the identification of polytopes representing consistent patterns of edges in a corrupted NOESY graph. Our randomized algorithm aggregates simplices into polytopes and fixes inconsistencies with simple local modifications, called rotations, that maintain most of the structure already uncovered. In characterizing the effects of experimental noise, we employ an NMR-specific random graph model in proving that our algorithm gives optimal performance in expected polynomial time, even when the input graph is significantly corrupted. We confirm this analysis in simulation studies with graphs corrupted by up to 500% noise. Finally, we demonstrate the practical application of the algorithm on several experimental beta-sheet datasets. Our approach is able to eliminate a large majority of noise edges and to uncover large consistent sets of interactions. Our algorithm has been implemented in the platform-independent Python code. The software can be freely obtained for academic use by request from the authors.

Antiretroviral Prophylaxis for HIV-1 Prevention among Heterosexual Men and Women

PubMed Central

Baeten, Jared M.; Donnell, Deborah; Ndase, Patrick; Mugo, Nelly R.; Campbell, James D.; Wangisi, Jonathan; Tappero, Jordan W.; Bukusi, Elizabeth A.; Cohen, Craig R.; Katabira, Elly; Ronald, Allan; Tumwesigye, Elioda; Were, Edwin; Fife, Kenneth H.; Kiarie, James; Farquhar, Carey; John-Stewart, Grace; Kakia, Aloysious; Odoyo, Josephine; Mucunguzi, Akasiima; Nakku-Joloba, Edith; Twesigye, Rogers; Ngure, Kenneth; Apaka, Cosmas; Tamooh, Harrison; Gabona, Fridah; Mujugira, Andrew; Panteleeff, Dana; Thomas, Katherine K.; Kidoguchi, Lara; Krows, Meighan; Revall, Jennifer; Morrison, Susan; Haugen, Harald; Emmanuel-Ogier, Mira; Ondrejcek, Lisa; Coombs, Robert W.; Frenkel, Lisa; Hendrix, Craig; Bumpus, Namandjé N.; Bangsberg, David; Haberer, Jessica E.; Stevens, Wendy S.; Lingappa, Jairam R.; Celum, Connie

2013-01-01

Introduction Antiretroviral pre-exposure prophylaxis (PrEP) reduces the incidence of acquisition of human immunodeficiency virus type 1 (HIV-1) in men who have sex with men and is a promising approach for preventing HIV-1 in heterosexual populations. Methods We conducted a randomized, three-arm trial of oral antiretroviral PrEP among heterosexual couples from Kenya and Uganda in which one member was HIV-1 seronegative and the other HIV-1 seropositive. Seronegative partners were randomly assigned to once-daily tenofovir (TDF), combination emtricitabine/tenofovir (FTC/TDF), or matching placebo and followed monthly for up to 36 months. At enrollment, HIV-1 seropositive partners were not eligible for antiretroviral therapy under national guidelines. All couples received standard HIV-1 treatment and prevention services, including individual and couples risk-reduction counseling and condoms. Results 4758 couples were enrolled; for 62%, the HIV-1 seronegative partner was male. For HIV-1 seropositive participants, the median CD4 count was 495 cells/μL (interquartile range 375–662). Of 82 post-randomization HIV-1 infections, 17 were among those assigned TDF (incidence 0.65 per 100 person-years), 13 among those assigned FTC/TDF (incidence 0.50 per 100 person-years), and 52 among those assigned placebo (incidence 1.99 per 100 person-years), indicating a 67% relative reduction in HIV-1 incidence for TDF (95% CI 44 to 81, p<0.001) and 75% for FTC/TDF (95% CI 55 to 87, p<0.001). HIV-1 protective effects of FTC/TDF and TDF were not significantly different (p=0.23), and both study medications significantly reduced HIV-1 incidence in both men and women. The rate of serious medical events was similar across the study arms. Conclusions Oral TDF and FTC/TDF provided substantial protection against HIV-1 acquisition in heterosexual men and women, with comparable efficacy of TDF and FTC/TDF. (Funded by the Bill and Melinda Gates Foundation; ClinicalTrials.gov number NCT00557245) PMID:22784037

Vision-Related Quality-of-Life Outcomes in the Mycotic Ulcer Treatment Trial I: A Randomized Clinical Trial.

PubMed

Rose-Nussbaumer, Jennifer; Prajna, N Venkatesh; Krishnan, K Tiruvengada; Mascarenhas, Jeena; Rajaraman, Revathi; Srinivasan, Muthiah; Raghavan, Anita; Oldenburg, Catherine E; O'Brien, Kieran S; Ray, Kathryn J; McLeod, Stephen D; Porco, Travis C; Lietman, Thomas M; Acharya, Nisha R; Keenan, Jeremy D

2015-06-01

Given the limitations in health care resources, quality-of-life measures for interventions have gained importance. To determine whether vision-related quality-of-life outcomes were different between the natamycin and voriconazole treatment arms in the Mycotic Ulcer Treatment Trial I, as measured by an Indian Vision Function Questionnaire. Secondary analysis (performed October 11-25, 2014) of a double-masked, multicenter, randomized, active comparator-controlled, clinical trial at multiple locations of the Aravind Eye Care System in South India that enrolled patients with culture- or smear-positive filamentous fungal corneal ulcers who had a baseline visual acuity of 20/40 to 20/400 (logMAR of 0.3-1.3). Study participants were randomly assigned to topical voriconazole, 1%, or topical natamycin, 5%. Subscale score on the Indian Vision Function Questionnaire from each of the 4 subscales (mobility, activity limitation, psychosocial impact, and visual function) at 3 months. A total of 323 patients were enrolled in the trial, and 292 (90.4%) completed the Indian Vision Function Questionnaire at 3 months. The majority of study participants had subscale scores consistent with excellent function. After adjusting for baseline visual acuity and organism, we found that study participants in the natamycin-treated group scored, on average, 4.3 points (95% CI, 0.1-8.5) higher than study participants in the voriconazole-treated group (P = .046). In subgroup analyses looking at ulcers caused by Fusarium species and adjusting for baseline best spectacle-corrected visual acuity, the natamycin-treated group scored 8.4 points (95% CI, 1.9-14.9) higher than the voriconazole-treated group (P = .01). Differences in quality of life were not detected for patients with Aspergillus or other non-Fusarium species as the causative organism (1.5 points [95% CI, -3.9 to 6.9]; P = .52). We found evidence of improvement in vision-related quality of life among patients with fungal ulcers who were randomly assigned to natamycin compared with those randomly assigned to voriconazole, and especially among patients with Fusarium species as the causative organism. Incorporation of quality-of-life measures in clinical trials is important to fully evaluate the effect of the studied interventions. clinicaltrials.gov Identifier:NCT00996736.

Clarithromycin therapy for bacteremic Mycobacterium avium complex disease. A randomized, double-blind, dose-ranging study in patients with AIDS. AIDS Clinical Trials Group Protocol 157 Study Team.

PubMed

Chaisson, R E; Benson, C A; Dube, M P; Heifets, L B; Korvick, J A; Elkin, S; Smith, T; Craft, J C; Sattler, F R

1994-12-15

To determine the antimicrobial activity and tolerability of clarithromycin for treating bacteremic Mycobacterium avium complex disease in patients with the acquired immunodeficiency syndrome (AIDS). A randomized, double-blind, dose-ranging study. Outpatient clinics. 154 patients with human immunodeficiency virus (HIV) infection and blood cultures positive for M. avium complex who had symptomatic disease. Random assignment to clarithromycin at dosages of 500 mg, 1000 mg, or 2000 mg twice daily for 12 weeks. Median number of colony-forming units of M. avium complex per milliliter of blood. Clarithromycin decreased mycobacterial CFUs from 2.7 to 2.8 log 10/mL of blood at baseline to less than 0 log 10/mL during follow-up (P < 0.0001). After 2 weeks, patients receiving 500 mg twice daily were less likely to be culture negative than were patients receiving 1000 or 2000 mg twice daily (11% compared with 33% or 29%; P = 0.08). At 6 weeks, the median number of CFUs of M. avium complex/mL of blood was 0 or 1 for all three groups. Clarithromycin-resistant isolates of M. avium complex developed in 46% of patients at a median of 16 weeks. Median survival was longer in patients assigned to 500 mg twice daily (median, 249 days) than in patients assigned to 1000 mg or 2000 mg. Death in the first 12 weeks was lowest in the 500-mg group (P = 0.007). Clarithromycin therapy acutely decreased M. avium complex bacteremia in patients with HIV infection by more than 99%. Clarithromycin, 500 mg twice daily, was well tolerated and associated with better survival. Emergence of clarithromycin-resistant organisms was an important problem.

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.

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

PubMed

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

2016-04-01

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

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

PubMed Central

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

2015-01-01

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

Immersive and interactive virtual reality to improve learning and retention of neuroanatomy in medical students: a randomized controlled study.

PubMed

Ekstrand, Chelsea; Jamal, Ali; Nguyen, Ron; Kudryk, Annalise; Mann, Jennifer; Mendez, Ivar

2018-02-23

Spatial 3-dimensional understanding of the brain is essential to learning neuroanatomy, and 3-dimensional learning techniques have been proposed as tools to enhance neuroanatomy training. The aim of this study was to examine the impact of immersive virtual-reality neuroanatomy training and compare it to traditional paper-based methods. In this randomized controlled study, participants consisted of first- or second-year medical students from the University of Saskatchewan recruited via email and posters displayed throughout the medical school. Participants were randomly assigned to the virtual-reality group or the paper-based group and studied the spatial relations between neural structures for 12 minutes after performing a neuroanatomy baseline test, with both test and control questions. A postintervention test was administered immediately after the study period and 5-9 days later. Satisfaction measures were obtained. Of the 66 participants randomly assigned to the study groups, 64 were included in the final analysis, 31 in the virtual-reality group and 33 in the paper-based group. The 2 groups performed comparably on the baseline questions and showed significant performance improvement on the test questions following study. There were no significant differences between groups for the control questions, the postintervention test questions or the 7-day postintervention test questions. Satisfaction survey results indicated that neurophobia was decreased. Results from this study provide evidence that training in neuroanatomy in an immersive and interactive virtual-reality environment may be an effective neuroanatomy learning tool that warrants further study. They also suggest that integration of virtual-reality into neuroanatomy training may improve knowledge retention, increase study motivation and decrease neurophobia. Copyright 2018, Joule Inc. or its licensors.

Immersive and interactive virtual reality to improve learning and retention of neuroanatomy in medical students: a randomized controlled study

PubMed Central

Ekstrand, Chelsea; Jamal, Ali; Nguyen, Ron; Kudryk, Annalise; Mann, Jennifer; Mendez, Ivar

2018-01-01

Background: Spatial 3-dimensional understanding of the brain is essential to learning neuroanatomy, and 3-dimensional learning techniques have been proposed as tools to enhance neuroanatomy training. The aim of this study was to examine the impact of immersive virtual-reality neuroanatomy training and compare it to traditional paper-based methods. Methods: In this randomized controlled study, participants consisted of first- or second-year medical students from the University of Saskatchewan recruited via email and posters displayed throughout the medical school. Participants were randomly assigned to the virtual-reality group or the paper-based group and studied the spatial relations between neural structures for 12 minutes after performing a neuroanatomy baseline test, with both test and control questions. A postintervention test was administered immediately after the study period and 5-9 days later. Satisfaction measures were obtained. Results: Of the 66 participants randomly assigned to the study groups, 64 were included in the final analysis, 31 in the virtual-reality group and 33 in the paper-based group. The 2 groups performed comparably on the baseline questions and showed significant performance improvement on the test questions following study. There were no significant differences between groups for the control questions, the postintervention test questions or the 7-day postintervention test questions. Satisfaction survey results indicated that neurophobia was decreased. Interpretation: Results from this study provide evidence that training in neuroanatomy in an immersive and interactive virtual-reality environment may be an effective neuroanatomy learning tool that warrants further study. They also suggest that integration of virtual-reality into neuroanatomy training may improve knowledge retention, increase study motivation and decrease neurophobia. PMID:29510979

Using Non-experimental Data to Estimate Treatment Effects

PubMed Central

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

2009-01-01

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

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

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.

Non-manipulation quantitative designs.

PubMed

Rumrill, Phillip D

2004-01-01

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

Comparing three toothpastes in controlling plaque and gingivitis: A 6-month clinical study.

PubMed

Triratana, Terdphong; Kraivaphan, Petcharat; Amornchat, Cholticha; Mateo, Luis R; Morrison, Boyce M; Dibart, Serge; Zhang, Yun-Po

2015-04-01

To investigate the clinical efficacy of three toothpastes in controlling established gingivitis and plaque over 6 months. 135 subjects were enrolled in a single-center, double-blind, parallel group, randomized clinical study. Subjects were randomly assigned to one of three treatments: triclosan/copolymer/fluoride dentifrice containing 0.3% triclosan, 2.0% copolymer and 1,450 ppm F as sodium fluoride in a silica base; herbal/bicarbonate dentifrice containing herbal extract and 1,400 ppm F as sodium fluoride in a sodium bicarbonate base; or fluoride dentifrice containing 450 ppm F as sodium fluoride, and 1,000 ppm F as sodium monofluorophosphate. Subjects were instructed to brush their teeth twice daily for 1 minute for 6 months. After 6 months, subjects assigned to the triclosan/copolymer/fluoride group exhibited statistically significant reductions in gingival index scores and plaque index scores as compared to subjects assigned to the herbal/bicarbonate group by 35.4% and 48.9%, respectively. There were no statistically significant differences in gingival index and plaque index between subjects in the herbal/ bicarbonate group and those in the fluoride group. The triclosan/copolymer/fluoride dentifrice was statistically significantly more effective in reducing gingivitis and dental plaque than the herbal/bicarbonate dentifrice, and this difference in efficacy was clinically meaningful.

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.

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

Effect of Allowing Choice of Diet on Weight Loss: A Randomized Trial.

PubMed

Yancy, William S; Mayer, Stephanie B; Coffman, Cynthia J; Smith, Valerie A; Kolotkin, Ronette L; Geiselman, Paula J; McVay, Megan A; Oddone, Eugene Z; Voils, Corrine I

2015-06-16

Choosing a diet rather than being prescribed one could improve weight loss. To examine whether offering choice of diet improves weight loss. Double-randomized preference trial of choice between 2 diets (choice) versus random assignment to a diet (comparator) over 48 weeks. (ClinicalTrials.gov: NCT01152359). Outpatient clinic at a Veterans Affairs medical center. Outpatients with a body mass index of at least 30 kg/m2. Choice participants received information about their food preferences and 2 diet options (low-carbohydrate diet [LCD] or low-fat diet [LFD]) before choosing and were allowed to switch diets at 12 weeks. Comparator participants were randomly assigned to 1 diet for 48 weeks. Both groups received group and telephone counseling for 48 weeks. The primary outcome was weight at 48 weeks. Of 105 choice participants, 61 (58%) chose the LCD and 44 (42%) chose the LFD; 5 (3 on the LCD and 2 on the LFD) switched diets at 12 weeks, and 87 (83%) completed measurements at 48 weeks. Of 102 comparator participants, 53 (52%) were randomly assigned to the LCD and 49 (48%) were assigned to the LFD; 88 (86%) completed measurements. At 48 weeks, estimated mean weight loss was 5.7 kg (95% CI, 4.3 to 7.0 kg) in the choice group and 6.7 kg (CI, 5.4 to 8.0 kg) in the comparator group (mean difference, -1.1 kg [CI, -2.9 to 0.8 kg]; P = 0.26). Secondary outcomes of dietary adherence, physical activity, and weight-related quality of life were similar between groups at 48 weeks. Only 2 diet options were provided. Results from this sample of older veterans might not be generalizable to other populations. Contrary to expectations, the opportunity to choose a diet did not improve weight loss.

An Open Label, Randomized, Comparative, Parallel Group, Multicenter, Prospective, Interventional, Clinical Study to Evaluate Efficacy and Safety of "AHPL/AYTOP/0113" in Comparison with "Framycetin Sulphate Cream" in Acute Wounds.

PubMed

Nipanikar, Sanjay U; Gajare, Kamalakar V; Vaidya, Vidyadhar G; Kamthe, Amol B; Upasani, Sachin A; Kumbhar, Vidyadhar S

2017-01-01

The main objective of the present study was to assess efficacy and safety of AHPL/AYTOP/0113 cream, a polyherbal formulation in comparison with Framycetin sulphate cream in acute wounds. It was an open label, randomized, comparative, parallel group and multi-center clinical study. Total 47 subjects were randomly assigned to Group-A (AHPL/AYTOP/0113 cream) and 42 subjects were randomly assigned to Group-B (Framycetin sulphate cream). All the subjects were advised to apply study drug, thrice daily for 21 days or up to complete wound healing (whichever was earlier). All the subjects were called for follow up on days 2, 4, 7, 10, 14, 17 and 21 or up to the day of complete wound healing. Data describing quantitative measures are expressed as mean ± SD. Comparison of variables representing categorical data was performed using Chi-square test. Group-A subjects took significantly less ( P < 0.05) i.e., (mean) 7.77 days than (mean) 9.87 days of Group-B subjects for wound healing. At the end of the study, statistically significant better ( P < 0.05) results were observed in Group-A than Group-B in mean wound surface area, wound healing parameters and pain associated with wound. Excellent overall efficacy and tolerability was observed in subjects of both the groups. No adverse event or adverse drug reaction was noted in any subject of both the groups. AHPL/AYTOP/0113 cream proved to be superior to Framycetin sulphate cream in healing of acute wounds.

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

PubMed

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

2015-08-01

Cluster randomized controlled trials (cRCTs; also known as group randomized trials and community-randomized trials) are multilevel experiments in which units that are randomly assigned to experimental conditions are sets of grouped individuals, whereas outcomes are recorded at the individual level. In human cRCTs, clusters that are randomly assigned are typically families, classrooms, schools, worksites, or counties. With growing interest in community-based, public health, and policy interventions to reduce obesity or improve nutrition, the use of cRCTs has increased. Errors in the design, analysis, and interpretation of cRCTs are unfortunately all too common. This situation seems to stem in part from investigator confusion about how the unit of randomization affects causal inferences and the statistical procedures required for the valid estimation and testing of effects. In this article, we provide a brief introduction and overview of the importance of cRCTs and highlight and explain important considerations for the design, analysis, and reporting of cRCTs by using published examples. © 2015 American Society for Nutrition.

A Study of Reliability of Marking and Absolute Grading in Secondary Schools

ERIC Educational Resources Information Center

Abdul Gafoor, K.; Jisha, P.

2014-01-01

Using a non-experimental comparative group design in a sample consisting of 100 English teachers randomly selected from 30 secondary schools of a district of Kerala and assigning fifty teachers to groups for marking and grading, this study compares inter and intra-individual reliability in marking and absolute grading. Studying (1) the in marking…

National Job Corps Study: Findings Using Administrative Earnings Records Data. Final Report

ERIC Educational Resources Information Center

Schochet; Peter Z.; McConnell, Sheena; Burghardt, John

2003-01-01

The National Job Corps Study has been conducted since 1993 to provide Congress and program managers with the information they need to assess how well Job Corps attains its goal of helping students become more responsible, employable, and productive citizens. The cornerstone of the study was the random assignment of all youths found eligible for…

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)…

Early Implementation Experiences of the 2010 Teacher Incentive Fund Grantees. NCEE Study Snapshot. NCEE 2014-4021

ERIC Educational Resources Information Center

National Center for Education Evaluation and Regional Assistance, 2014

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…

The Effect of Using Computer Edutainment on Developing 2nd Primary Graders' Writing Skills

ERIC Educational Resources Information Center

Mohammed Abdel Raheem, Azza Ashraf

2011-01-01

The present study attempted to examine the effect of using computer edutainment on developing 2nd graders' writing skills. The study comprised thirty-second year primary stage enrolled in Bani Hamad primary governmental school, Minia governorate. The study adopted the quasi-experimental design. Thirty participants were randomly assigned to one…

Teaching about Psychological Disorders: A Case for Using Discussion Boards in the Classroom

ERIC Educational Resources Information Center

Sheen, Mercedes; AlJassmi, Maryam A.; Jordan, Timothy R.

2017-01-01

This study compares the traditional use of case studies against the novel use of discussion boards to teach naive students in the United Arab Emirates about anxiety disorders. Sixty-six female students from an abnormal psychology class were randomly assigned to either the case study condition (CSC) or the discussion board condition (DBC). Students…

Examining the Impact of Technology on Primary Students' Revision of Written Work

ERIC Educational Resources Information Center

Lisy, Jennifer Garrette

2015-01-01

Few studies have examined the revision processes of second grade students and even fewer have explored the impact of digital writing on young students' revisions. This study utilized a within subject crossover trial using randomized block assignment (AB | BA) for counterbalancing. This study sought to determine (1) whether revising on paper versus…

Attributions about Perpetrators and Victims of Interpersonal Abuse: Results from an Analogue Study

ERIC Educational Resources Information Center

Langhinrichsen-Rohling, Jennifer; Shlien-Dellinger, Rania K.; Huss, Matthew T.; Kramer, Vertrie L.

2004-01-01

This analogue study (written vignettes and videotapes) examines the influence of victim-perpetrator relationship (spouse or acquaintance), sex of perceiver, and type of abuse (psychological vs. physical) on attributions about victims and perpetrators of domestic abuse. College student participants (73 men, 108 women) were randomly assigned to…

Technology-Enhanced Peer Review: Benefits and Implications of Providing Multiple Reviews

ERIC Educational Resources Information Center

Papadopoulos, Pantelis M.; Lagkas, Thomas D.; Demetriadis, Stavros N.

2017-01-01

This study analyses the impact of self and peer feedback in technology-enhanced peer review settings. The impact of receiving peer comments ("receiver" perspective) is compared to that of reaching own insights by reviewing others' work ("giver" perspective). In this study, 38 sophomore students were randomly assigned in two…

Impact of Thematic Approach on Communication Skill in Preschool

ERIC Educational Resources Information Center

Ashokan, Varun; Venugopal, Kalpana

2016-01-01

The study investigated the effects of thematic approach on communication skills for preschool children. The study was a quasi experimental non-equivalent pretest-post-test control group design whereby 5-6 year old preschool children (n = 49) were randomly assigned to an experimental and a control group. The experimental group students were exposed…

The Impact of Video-Based Materials on Chinese-Speaking Learners' English Text Comprehension

ERIC Educational Resources Information Center

Lin, Lu-Fang

2016-01-01

This study investigated whether video-based materials can facilitate second language learners' text comprehension at the levels of macrostructure and microstructure. Three classes inclusive of 98 Chinese-speaking university students joined this study. The three classes were randomly assigned to three treatment groups: on-screen text (T Group),…

A Meta-Analysis of Massage Therapy Research

ERIC Educational Resources Information Center

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

2004-01-01

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

Using Environmental Stimuli in Physical Activity Intervention for School Teachers: A Pilot Study

ERIC Educational Resources Information Center

Cheung, Peggy PY.; Chow, Bik C.; Parfitt, Gaynor

2008-01-01

The purpose of the present study was to examine the effectiveness of a six-week intervention that aimed to promote teachers' physical activity level during working hours. Thirty-eight teachers from three intervention schools (schools randomly assigned as intervention group) received intervention prompts: SMS messages, leaflets and posters…

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

ERIC Educational Resources Information Center

Trautmann, Nancy M.

2009-01-01

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

The Influence of Art Making on Anxiety: A Pilot Study

ERIC Educational Resources Information Center

Sandmire, David Alan; Gorham, Sarah Roberts; Rankin, Nancy Elizabeth; Grimm, David Robert

2012-01-01

This study examined the psychological effects of art making in a sample of 57 undergraduate students. One week prior to final examinations, participants were randomly assigned to either an art-making group or a control group. The State-Trait Anxiety Inventory was administered before and after participation. Art making activities included painting…

The Influence of Mathematical Ability and Morning Nutrition on Mental Arithmetic in Preadolescents: An ERP study.

USDA-ARS?s Scientific Manuscript database

The effects of eating or skipping breakfast on ERP correlates of mental arithmetic were studied in preadolescents differing in experience (age) and mathematical skills. Participants, randomly assigned to treatment [eat (B) or skip (SB) breakfast (each, n = 41)], were sub-grouped by age [8.8 yrs (B: ...

Effects of Choice and Social-Undesirability on Unprovoked Aggression.

ERIC Educational Resources Information Center

Sejwacz, Dorothy; Dion, Kenneth L.

Female subjects in this study were induced to harm another person in an alleged "learning" study by administering aversive noise to a confederate-victim as she performed a problem-solving task. The subjects consisted of forty-six female undergraduates enrolled in Introductory Psychology at the University of Toronto. They were randomly assigned to…

Preventing Adolescents' Externalizing and Internalizing Symptoms: Effects of the Penn Resiliency Program

ERIC Educational Resources Information Center

Cutuli, J. J.; Gillham, Jane E.; Chaplin, Tara M.; Reivich, Karen J.; Seligman, Martin E. P.; Gallop, Robert J.; Abenavoli, Rachel M.; Freres, Derek R.

2013-01-01

This study reports secondary outcome analyses from a past study of the Penn Resiliency Program (PRP), a cognitive-behavioral depression prevention program for middle-school aged children. Middle school students (N = 697) were randomly assigned to PRP, PEP (an alternate intervention), or control conditions. Gillham et al., (2007) reported analyses…

Mobile Seamless Technology Enhanced CSL Oral Communication

ERIC Educational Resources Information Center

Lan, Yu-Ju; Lin, Yen-Ting

2016-01-01

The current study aimed at investigating how mobile seamless technology can be used to enhance the pragmatic competence of learners of Chinese as a second language (CSL). 34 overseas CSL learners participated in this study. They were randomly assigned into two groups: the classroom group, executing language tasks in fake contexts in a traditional…

Prior-to-Exam: What Activities Enhance Performance?

ERIC Educational Resources Information Center

Rhoads, C. J.; Healy, Therese

2013-01-01

Can instructors impact their student performance by recommending an activity just prior to taking an exam? In this study, college students were randomly assigned to one of three treatment groups (study, exercise, or meditation) or a control group. Each group was given two different types of tests; a traditional concept exam, and a non-traditional…

Can Coloring Mandalas Reduce Anxiety? A Replication Study

ERIC Educational Resources Information Center

van der Vennet, Renee; Serice, Susan

2012-01-01

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

A Waitlist-Controlled Trial of Behavioral Parent Training for Fathers of Children with ADHD

ERIC Educational Resources Information Center

Fabiano, Gregory A.; Pelham, William E.; Cunningham, Charles E.; Yu, Jihnhee; Gangloff, Brian; Buck, Melina; Linke, Stuart; Gormley, Matthew; Gera, Shradha

2012-01-01

Fathers, in general, have been underrepresented in studies of parent training outcome for children with attention deficit hyperactivity disorder (ADHD), and the present study aimed to investigate the efficacy of a behavioral parent training program developed expressly for fathers. The present investigation randomly assigned 55 fathers of children…

Application of Network Planning to Teaching Wind-Surfing

ERIC Educational Resources Information Center

Zybko, Przemyslaw; Jaczynowski, Lech

2008-01-01

Study aim: To determine the effects of network planning on teaching untrained subjects windsurfing. Material and methods: Untrained physical education students (n = 390), aged 19-23 years, took part in the study while staying on a summer camp. They were randomly assigned into two groups: experimental (n = 216) and control (n = 174). Two methods of…

Advancing Scientific Reasoning in Upper Elementary Classrooms: Direct Instruction versus Task Structuring

ERIC Educational Resources Information Center

Lazonder, Ard W.; Wiskerke-Drost, Sjanou

2015-01-01

Several studies found that direct instruction and task structuring can effectively promote children's ability to design unconfounded experiments. The present study examined whether the impact of these interventions extends to other scientific reasoning skills by comparing the inquiry activities of 55 fifth-graders randomly assigned to one of…

Exploring the Boundary Conditions of the Redundancy Principle

ERIC Educational Resources Information Center

McCrudden, Matthew T.; Hushman, Carolyn J.; Marley, Scott C.

2014-01-01

This experiment investigated whether study of a scientific text and a visual display that contained redundant text segments would affect memory and transfer. The authors randomly assigned 42 students from a university in the southwestern United States in equal numbers to 1 of 2 conditions: (a) a redundant condition, in which participants studied a…

Effects of Shuttlecock-Playing on Physical Fitness in College Students

ERIC Educational Resources Information Center

Zhang, Tingran; Luo, Jiong

2015-01-01

The purpose of this study was to investigate the exercise intensity and the physical fitness effect of shuttlecock playing. 18 normal body weight college students voluntarily participated in this study. They were randomly assigned to shuttlecock playing (SCP) and control groups. The SCP underwent a 15-week shuttlecock-playing program, but the…

Attrition Standard. WWC Standards Brief

ERIC Educational Resources Information Center

What Works Clearinghouse, 2017

2017-01-01

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

Iranian University Students' Experiences of and Attitudes Towards Alternatives in Assessment

ERIC Educational Resources Information Center

Sadeghi, Karim; Abolfazli Khonbi, Zainab

2015-01-01

This study investigated the effect of assessment type (self vs. peer vs. teacher) on university students' academic achievement and students' attitudes toward them. In the main study, 82 undergraduate English-as-a-Foreign-Language students in four classes at three universities in Iran were randomly assigned into one of self-, peer- and…

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…

A Randomised Efficacy Study of Web-Based Synthetic and Analytic Programmes among Disadvantaged Urban Kindergarten Children

ERIC Educational Resources Information Center

Comaskey, Erin M.; Savage, Robert S.; Abrami, Philip

2009-01-01

This study explores whether two computer-based literacy interventions--a "synthetic phonics" and an "analytic phonics" approach produce qualitatively distinct effects on the early phonological abilities and reading skills of disadvantaged urban Kindergarten (Reception) children. Participants (n=53) were assigned by random allocation to one of the…

Predictors and Moderators of Acute Outcome in the Treatment for Adolescents with Depression Study (TADS)

ERIC Educational Resources Information Center

Curry, John; Rohde, Paul; Simons, Anne; Silva, Susan; Vitiello, Benedetto; Kratochvil, Christopher; Reinecke, Mark; Feeny, Norah; Wells, Karen; Pathak, Sanjeev; Weller, Elizabeth; Rosenberg, David; Kennard, Betsy; Robins, Michele; Ginsburg, Golda; March, John

2006-01-01

Objective: To identify predictors and moderators of response to acute treatments among depressed adolescents (N = 439) randomly assigned to fluoxetine, cognitive-behavioral therapy (CBT), both fluoxetine and CBT, or clinical management with pill placebo in the Treatment for Adolescents With Depression Study (TADS). Method: Potential baseline…

Implementing Team-Based Learning in Middle School Social Studies Classes

ERIC Educational Resources Information Center

Wanzek, Jeanne; Kent, Shawn C.; Vaughn, Sharon; Swanson, Elizabeth A.; Roberts, Greg; Haynes, Martha

2015-01-01

The authors examined the effects of team-based learning (TBL) implemented in Grade 8 social studies classes on student content acquisition. Twenty-four classes were randomly assigned to treatment or comparison blocking on teacher. In the treatment classes teachers integrated TBL practices in the content instruction. The authors examined teacher…

The Effects on Students' Conceptual Understanding of Electric Circuits of Introducing Virtual Manipulatives within a Physical Manipulatives-Oriented Curriculum

ERIC Educational Resources Information Center

Zacharia, Zacharias C.; de Jong, Ton

2014-01-01

This study investigates whether Virtual Manipulatives (VM) within a Physical Manipulatives (PM)-oriented curriculum affect conceptual understanding of electric circuits and related experimentation processes. A pre-post comparison study randomly assigned 194 undergraduates in an introductory physics course to one of five conditions: three…

Silent Illumination: A Study on Chan (Zen) Meditation, Anxiety, and Musical Performance Quality

ERIC Educational Resources Information Center

Lin, Peter; Chang, Joanne; Zemon, Vance; Midlarsky, Elizabeth

2008-01-01

This study investigated the effects of Chan (Zen) meditation on musical performance anxiety and musical performance quality. Nineteen participants were recruited from music conservatories and randomly assigned to either an eight-week meditation group or a wait-list control group. After the intervention, all participants performed in a public…

Promoting Physical Activity in Girls: A Case Study of One School's Success.

ERIC Educational Resources Information Center

Felton, Gwen; Saunders, Ruth P.; Ward, Dianne S.; Dishman, Rod K.; Dowda, Marsha; Pate, Russell R.

2005-01-01

This case study profiles one of 24 high schools that participated in a school-based, NIH-funded study to increase physical activity among high school girls. The case study school was one of 12 randomly assigned to the intervention group. The study intervention was based on the premise that a successful intervention is developed and tailored by…

Intraoperative Sedation With Dexmedetomidine is Superior to Propofol for Elderly Patients Undergoing Hip Arthroplasty: A Prospective Randomized Controlled Study.

PubMed

Mei, Bin; Meng, Gaige; Xu, Guanghong; Cheng, Xinqi; Chen, Shishou; Zhang, Ye; Zhang, Ming; Liu, Xuesheng; Gu, Erwei

2018-03-09

Peripheral nerve block is a preferable method for elderly patients receiving hip arthroplasty. Sedation with dexmedetomidine may reduce postoperative delirium. The aim of this study was to investigate whether intraoperative sedation with dexmedetomidine, as a supplementary to peripheral nerve block for elderly patients receiving total hip arthroplasty, can decrease the prevalence of postoperative delirium. A prospective, randomized controlled study was conducted with patients 65 years of age or older who underwent total hip arthroplasty between June 2016 and June 2017. The patients were randomly assigned to receive a lumbosacral plexus plus T12 paravertebral block supplemented with propofol or dexmedetomidine for sedation. Incidence of postoperative delirium was the primary endpoint and was determined with the Confusion Assessment Method, and incidence of postoperative cognitive dysfunction was assessed with the Mini-Mental State Examination. The time of ambulation, discharge time, and complications over a 30-day post-surgery period were also recorded. 296 patients were randomly assigned to two groups. The patients sedated with dexmedetomidine had lower incidences of postoperative delirium and postoperative cognitive dysfunction and were out of bed and discharged sooner than the patients sedated with propofol. There was no difference in complications between the two groups. As a supplementary to peripheral nerve block, intraoperative sedation with dexmedetomidine could be associated with a lower incidence of POD, which may have benefits on reducing the incidence of early postoperative cognitive dysfunction and offering a better short-term recovery for elderly patients receiving hip arthroplasty.

Designing Studies That Would Address the Multilayered Nature of Health Care

PubMed Central

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

2010-01-01

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

An Investigation of Effectiveness of Conceptual Change Text-oriented Instruction on Students' Understanding of Solution Concepts

NASA Astrophysics Data System (ADS)

Pinarbaşi; , Tacettin; Canpolat, Nurtaç; Bayrakçeken, Samih; Geban, Ömer

2006-12-01

This study investigated the effect of conceptual change text-oriented instruction over traditional instruction on students' understanding of solution concepts (e.g., dissolving, solubility, factors affecting solubility, concentrations of solutions, types of solutions, physical properties of solutions) and their attitudes towards chemistry. The sample of this study consisted of 87 undergraduate students from two classes enrolled in an introductory chemistry course. One of the classes was assigned randomly to the control group, and the other class were assigned randomly to the experimental group. During teaching the topic of solution concepts in the chemistry curriculum, a conceptual change text-oriented instruction was applied in the experimental group whereas traditional instruction was followed in the control group. The results showed that the students in the experimental group performed better with respect to solution concepts. In addition, it has been found that there was no significant difference between the attitudes of students in the experimental and control groups towards chemistry.

Strategic Resource Use for Learning: A Self-Administered Intervention That Guides Self-Reflection on Effective Resource Use Enhances Academic Performance.

PubMed

Chen, Patricia; Chavez, Omar; Ong, Desmond C; Gunderson, Brenda

2017-06-01

Many educational policies provide learners with more resources (e.g., new learning activities, study materials, or technologies), but less often do they address whether students are using these resources effectively. We hypothesized that making students more self-reflective about how they should approach their learning with the resources available to them would improve their class performance. We designed a novel Strategic Resource Use intervention that students could self-administer online and tested its effects in two cohorts of a college-level introductory statistics class. Before each exam, students randomly assigned to the treatment condition strategized about which academic resources they would use for studying, why each resource would be useful, and how they would use their resources. Students randomly assigned to the treatment condition reported being more self-reflective about their learning throughout the class, used their resources more effectively, and outperformed students in the control condition by an average of one third of a letter grade in the class.

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

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

PubMed

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

2003-01-01

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

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.

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

PubMed

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

2018-01-01

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

47 CFR 1.994 - Routine terms and conditions.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Random Selection Wireless Radio Services Applications and Proceedings Foreign Ownership of Common Carrier... or spectrum leasing arrangement by assignment or transfer of control provided that the subsidiary or... license or spectrum leasing arrangement by assignment or transfer of control provided that the subsidiary...

47 CFR 1.994 - Routine terms and conditions.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Random Selection Wireless Radio Services Applications and Proceedings Foreign Ownership of Common Carrier... or spectrum leasing arrangement by assignment or transfer of control provided that the subsidiary or... license or spectrum leasing arrangement by assignment or transfer of control provided that the subsidiary...

Randomized Trial of Hepatic Artery Embolization for Hepatocellular Carcinoma Using Doxorubicin-Eluting Microspheres Compared With Embolization With Microspheres Alone

PubMed Central

Do, Richard K.; Gonen, Mithat; Covey, Anne M.; Getrajdman, George I.; Sofocleous, Constantinos T.; Jarnagin, William R.; D’Angelica, Michael I.; Allen, Peter J.; Erinjeri, Joseph P.; Brody, Lynn A.; O’Neill, Gerald P.; Johnson, Kristian N.; Garcia, Alessandra R.; Beattie, Christopher; Zhao, Binsheng; Solomon, Stephen B.; Schwartz, Lawrence H.; DeMatteo, Ronald; Abou-Alfa, Ghassan K.

2016-01-01

Purpose Transarterial chemoembolization is accepted therapy for hepatocellular carcinoma (HCC). No randomized trial has demonstrated superiority of chemoembolization compared with embolization, and the role of chemotherapy remains unclear. This randomized trial compares the outcome of embolization using microspheres alone with chemoembolization using doxorubicin-eluting microspheres. Materials and Methods At a single tertiary referral center, patients with HCC were randomly assigned to embolization with microspheres alone (Bead Block [BB]) or loaded with doxorubicin 150 mg (LC Bead [LCB]). Random assignment was stratified by number of embolizations to complete treatment, and assignments were generated by permuted blocks in the institutional database. The primary end point was response according to RECIST 1.0 (Response Evaluation Criteria in Solid Tumors) using multiphase computed tomography 2 to 3 weeks post-treatment and then at quarterly intervals, with the reviewer blinded to treatment allocation. Secondary objectives included safety and tolerability, time to progression, progression-free survival, and overall survival. This trial is currently closed to accrual. Results Between December 2007 and April 2012, 101 patients were randomly assigned: 51 to BB and 50 to LCB. Demographics were comparable: median age, 67 years; 77% male; and 22% Barcelona Clinic Liver Cancer stage A and 78% stage B or C. Adverse events occurred with similar frequency in both groups: BB, 19 of 51 patients (38%); LCB, 20 of 50 patients (40%; P = .48), with no difference in RECIST response: BB, 5.9% versus LCB, 6.0% (difference, −0.1%; 95% CI, −9% to 9%). Median PFS was 6.2 versus 2.8 months (hazard ratio, 1.36; 95% CI, 0.91 to 2.05; P = .11), and overall survival, 19.6 versus 20.8 months (hazard ratio, 1.11; 95% CI, 0.71 to 1.76; P = .64) for BB and LCB, respectively. Conclusion There was no apparent difference between the treatment arms. These results challenge the use of doxorubicin-eluting beads for chemoembolization of HCC. PMID:26834067

A comparative study of restricted randomization procedures for multiarm trials with equal or unequal treatment allocation ratios.

PubMed

Ryeznik, Yevgen; Sverdlov, Oleksandr

2018-06-04

Randomization designs for multiarm clinical trials are increasingly used in practice, especially in phase II dose-ranging studies. Many new methods have been proposed in the literature; however, there is lack of systematic, head-to-head comparison of the competing designs. In this paper, we systematically investigate statistical properties of various restricted randomization procedures for multiarm trials with fixed and possibly unequal allocation ratios. The design operating characteristics include measures of allocation balance, randomness of treatment assignments, variations in the allocation ratio, and statistical characteristics such as type I error rate and power. The results from the current paper should help clinical investigators select an appropriate randomization procedure for their clinical trial. We also provide a web-based R shiny application that can be used to reproduce all results in this paper and run simulations under additional user-defined experimental scenarios. Copyright © 2018 John Wiley & Sons, Ltd.

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

PubMed

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

2014-01-01

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

College Students' Study Strategies as a Function of Testing: An Investigation into Metacognitive Self-Regulation

ERIC Educational Resources Information Center

Ross, Margaret E.; Green, Samuel B.; Salisbury-Glennon, Jill D.; Tollefson, Nona

2006-01-01

We conducted the present study to investigate whether college students adjust their study strategies to meet the cognitive demands of testing, a metacognitive self-regulatory skill. Participants were randomly assigned to one of the two testing conditions. In one condition we told participants to study for a test that required deep-level cognitive…

Benefits, Costs, and Explanation of the High/Scope Perry Preschool Program.

ERIC Educational Resources Information Center

Schweinhart, Lawrence J.

The High/Scope Perry Preschool Study is a study of the effects of a high-quality preschool program for children born in poverty. Following 123 children randomly assigned to program or no-program control groups, the study has had little attrition on a variety of measures from age 3 to age 41. The study has found evidence of preschool program…

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

ERIC Educational Resources Information Center

Kus, Metin; Filiz, Erkan; Altun, Sertel

2014-01-01

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

Case Studies' Effect on Undergraduates' Achievement, Attitudes, and Team Shared Mental Models in Educational Psychology

ERIC Educational Resources Information Center

Razzouk, Rim; Johnson, Tristan E.

2013-01-01

The purpose of this study was to examine the effect of case studies on learning outcomes, attitudes toward instructions, and team shared mental models (SMM) in a team-based learning environment in an undergraduate educational psychology course. Approximately 105 students who participated in this study were randomly assigned to either a case-study…

Advisor-Teller Money Manager (ATM) Therapy for Substance Use Disorders

PubMed Central

Rosen, Marc I.; Rounsaville, Bruce J.; Ablondi, Karen; Black, Anne C.; Rosenheck, Robert A.

2011-01-01

Objective Patients with concomitant psychiatric and substance use disorders are commonly assigned representative payees or case managers to help manage their funds, but money management has not been conceptualized as a theory-based treatment. This randomized clinical trial was conducted to determine the effect of a money management–based therapy, advisor-teller money manager (ATM), on substance abuse or dependence. Methods Ninety patients at a community mental health center who had a history of cocaine or alcohol abuse or dependence were assessed after random assignment to 36 weeks of ATM (N=47) or a control condition in which use of a financial workbook was reviewed (N=43). Patients assigned to ATM were encouraged to deposit their funds into a third-party account, plan weekly expenditures, and negotiate monthly budgets. Substance use calendars and urine toxicology tests were collected every other week for 36 weeks and again 52 weeks after randomization. Results Patients assigned to ATM had significantly more negative toxicologies for cocaine metabolite over time than patients in the control group, and treating clinicians rated ATM patients as significantly more likely to be abstinent from illicit drugs. Self-reported abstinence from alcohol did not significantly differ between groups. Unexpectedly, patients assigned to ATM were more likely to be assigned a representative payee or a conservator than control participants during the follow-up period (ten of 47 versus two of 43). One patient in ATM assaulted the therapist when his check had not arrived. Conclusions ATM is an efficacious therapy for the treatment of cocaine abuse or dependence among people with concomitant psychiatric illness but requires protection of patient autonomy and staff safety. PMID:20592006

Homeless Veterans' Use of Peer Mentors and Effects on Costs and Utilization in VA Clinics.

PubMed

Yoon, Jean; Lo, Jeanie; Gehlert, Elizabeth; Johnson, Erin E; O'Toole, Thomas P

2017-06-01

The study compared health care utilization and costs among homeless veterans randomly assigned to peer mentors or usual care and described contacts with peer mentors. Homeless patients at four Department of Veterans Affairs clinics were randomly assigned to a peer mentor (N=195) or to usual care (N=180). Administrative data on utilization and costs over a six-month follow-up were combined with peer mentors' reports of patient contacts. Most patients (87%) in the peer mentor group had at least one peer contact. Patients in this group spent the largest proportions of time discussing housing and health issues with peer mentors and had more outpatient encounters than those in usual care, although differences were not significant. No other between-group differences were found in utilization or costs. Although significant impacts of peer mentors on health care patterns or costs were not detected, some patients had frequent contact with peer mentors.

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

PubMed

Li, Yi; Guo, Guang

2016-09-01

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

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

PubMed

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

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

IMMEDIATE AND SHORT-TERM EFFECTS OF THE 5TH GRADE VERSION OF THE keepin’ it REAL SUBSTANCE USE PREVENTION INTERVENTION*

PubMed Central

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

2010-01-01

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 condition, implementing the school’s pre-existing substance use prevention programming. Students (n = 1,566) completed a questionnaire prior to curriculum implementation and follow-up questionnaires toward the end of 5th and 6th grade. The 5th grade kiR curriculum generally appeared no more effective than the control schools’ programming in changing students’ resistance or decision-making skills; substance use intentions, expectancies, or normative beliefs; or lifetime and recent substance use. Such findings have implications for the age appropriateness of school-based programs. PMID:19157042

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

PubMed

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

2016-12-01

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

Improving the quality of depression and pain care in multiple sclerosis using collaborative care: The MS-care trial protocol.

PubMed

Ehde, Dawn M; Alschuler, Kevin N; Sullivan, Mark D; Molton, Ivan P; Ciol, Marcia A; Bombardier, Charles H; Curran, Mary C; Gertz, Kevin J; Wundes, Annette; Fann, Jesse R

2018-01-01

Evidence-based pharmacological and behavioral interventions are often underutilized or inaccessible to persons with multiple sclerosis (MS) who have chronic pain and/or depression. Collaborative care is an evidence-based patient-centered, integrated, system-level approach to improving the quality and outcomes of depression care. We describe the development of and randomized controlled trial testing a novel intervention, MS Care, which uses a collaborative care model to improve the care of depression and chronic pain in a MS specialty care setting. We describe a 16-week randomized controlled trial comparing the MS Care collaborative care intervention to usual care in an outpatient MS specialty center. Eligible participants with chronic pain of at least moderate intensity (≥3/10) and/or major depressive disorder are randomly assigned to MS Care or usual care. MS Care utilizes a care manager to implement and coordinate guideline-based medical and behavioral treatments with the patient, clinic providers, and pain/depression treatment experts. We will compare outcomes at post-treatment and 6-month follow up. We hypothesize that participants randomly assigned to MS Care will demonstrate significantly greater control of both pain and depression at post-treatment (primary endpoint) relative to those assigned to usual care. Secondary analyses will examine quality of care, patient satisfaction, adherence to MS care, and quality of life. Study findings will aid patients, clinicians, healthcare system leaders, and policy makers in making decisions about effective care for pain and depression in MS healthcare systems. (PCORI- IH-1304-6379; clinicaltrials.gov: NCT02137044). This trial is registered at ClinicalTrials.gov, protocol NCT02137044. Copyright © 2017 Elsevier Inc. All rights reserved.

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.

Responding to Misinformation about Climate Change

ERIC Educational Resources Information Center

Lawrence, Eva K.; Estow, Sarah

2017-01-01

This study examined responses to climate change misinformation and messages designed to counter misinformation. Participants (N = 406) first responded to a social media post denying the existence of global warming and then were randomly assigned to read one of three responses to the original post (correction, collaboration, control). Participants…

Linking Stereotype Threat and Anxiety

ERIC Educational Resources Information Center

Osborne, Jason W.

2007-01-01

Claude Steele's stereotype threat hypothesis has attracted significant attention in recent years. This study tested one of the main tenets of his theory--that stereotype threat serves to increase individual anxiety levels, thus hurting performance--using real-time measures of physiological arousal. Subjects were randomly assigned to either high or…

Note Taking and Recall

ERIC Educational Resources Information Center

Fisher, Judith L.; Harris, Mary B.

1974-01-01

To study the effect of note taking and opportunity for review on subsequent recall, 88 college students were randomly assigned to five treatment groups utilizing different note taking and review combinations. No treatment effects were found, although quality of notes was positively correlated with free recall an multiple-choice measures.…

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...

75 FR 9189 - Notice of Proposed Information Collection Requests

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-01

... mandated standardized test scores); follow-up surveys for students; teacher and parent rating/observation on various student aspects (e.g., student social skills); baseline and follow-up surveys for teachers... Character (LIC) program. This study is based on an experimental design that utilizes the random assignment...

Dismantling Stereotypes about Latinos in STEM

ERIC Educational Resources Information Center

Hernandez, Diley; Rana, Shaheen; Rao, Analia; Usselman, Marion

2017-01-01

The present study compared the effectiveness of a self-affirmation and a role model guest lecture intervention on reducing students' perceptions of science-related social identity threat. Participants included 67 Latino high school students enrolled in a college preparation program. Students were randomly assigned either to a self-affirmation…

The State, Not the Trait, of Nostalgia Increases Creativity

ERIC Educational Resources Information Center

Ye, Shengquan; Ngan, Rose Ying Lam; Hui, Anna N. N.

2013-01-01

Nostalgic experience evokes emotions and activates the cognitive process of recalling and reconstructing information in memory. This study investigated the effects of nostalgia on creativity using experiments and questionnaires. Two-hundred-and-eighty university students were randomly assigned to experimental and control groups, in which…

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

ERIC Educational Resources Information Center

Saczynski, Jane; Margrett, Jennifer; Willis, Sherry

2004-01-01

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

Mature Results of a Prospective Randomized Trial Comparing 5-Flourouracil with Leucovorin to 5-Flourouracil with Levamisole as Adjuvant Therapy of Stage II and III Colorectal Cancer- The Israel Cooperative Oncology Group (ICOG) Study

PubMed Central

Figer, Arie; Nissan, Aviram; Shani, Adi; Borovick, Riva; Stiener, Mariana; Baras, Mario; Freund, Herbert R.; Sulkes, Aaron; Stojadinovic, Alexander; Peretz, Tamar

2011-01-01

Objective: Survival benefit with adjuvant therapy was shown in patients with Stage III colorectal cancer (CRC). This study evaluates long-term (10-year) outcome in patients with CRC randomly assigned to adjuvant 5-Fluorouracil/Leucovorin (5FU+LV) or 5-FU/Levamisole (5FU+LEV). Methods: Between 1990 and 1995, 398 patients with curatively resected Stage II-III CRC were randomly assigned to adjuvant 5FU+LV or 5FU+LEV for 12 months. Results: No difference was evident in 10-year relapse-free or overall survival between study groups. Grade III toxicity was similar between groups; however, neurotoxicity was significantly greater with 5FU+LEV (p=0.02) and gastrointestinal toxicity with 5FU+LV (p=0.03). Female patients treated with 5FU+LEV had improved overall survival. Conclusions: Adjuvant treatment of CRC is still based on leucovorin modulated fluorouracil. The long-term follow-up results of this trial indicate that the adjuvant treatment of Stage II-III CRC with 5FU+LV or 5FU+LEV is equally effective. The finding of improved survival in female subjects treated with 5FU+LEV warrants further study to determine if Levamisole is a better modulator of 5-FU than Leucovorin in this patient subset. PMID:21475636

An Investigation of Factors Influencing Learning in the Mentally Retarded, and Their Use in the Design of Instructional Materials; Effects of a Set for Delayed Response on Recall by MR's. Interim Report.

ERIC Educational Resources Information Center

Seitz, Sue; Morris, Dan

In a study on short term memory, 32 educable mentally retarded subjects (mean IQ 62.68, mean mental age 103.78 months) were randomly assigned to each of the four experimental conditions. An automated machine presented the stimuli (32 three-letter words) and the interference items (a list of random numbers read aloud between stimuli presentations).…

Effects of Guided Imagery on Postoperative Outcomes in Patients Undergoing Same-Day Surgical Procedures: A Randomized, Single-Blind Study

DTIC Science & Technology

2010-06-01

2O0O;9Ot3):706-712. 20. Bertrand P, Maye J. A description of the indices of heart rate variabil- ity in orofacial pain paticnis. Bcihcsda, MD: National...neck proce- dures were randomly assigned into 2 groups for this single-blind investigation. Anxiety and baseline pain levels were documented...control group patients received no intervention. Data were collected on pain and nar- cotic consumption at 7- and 2-hour postoperative inter- vals. In

Bias analysis applied to Agricultural Health Study publications to estimate non-random sources of uncertainty.

PubMed

Lash, Timothy L

2007-11-26

The associations of pesticide exposure with disease outcomes are estimated without the benefit of a randomized design. For this reason and others, these studies are susceptible to systematic errors. I analyzed studies of the associations between alachlor and glyphosate exposure and cancer incidence, both derived from the Agricultural Health Study cohort, to quantify the bias and uncertainty potentially attributable to systematic error. For each study, I identified the prominent result and important sources of systematic error that might affect it. I assigned probability distributions to the bias parameters that allow quantification of the bias, drew a value at random from each assigned distribution, and calculated the estimate of effect adjusted for the biases. By repeating the draw and adjustment process over multiple iterations, I generated a frequency distribution of adjusted results, from which I obtained a point estimate and simulation interval. These methods were applied without access to the primary record-level dataset. The conventional estimates of effect associating alachlor and glyphosate exposure with cancer incidence were likely biased away from the null and understated the uncertainty by quantifying only random error. For example, the conventional p-value for a test of trend in the alachlor study equaled 0.02, whereas fewer than 20% of the bias analysis iterations yielded a p-value of 0.02 or lower. Similarly, the conventional fully-adjusted result associating glyphosate exposure with multiple myleoma equaled 2.6 with 95% confidence interval of 0.7 to 9.4. The frequency distribution generated by the bias analysis yielded a median hazard ratio equal to 1.5 with 95% simulation interval of 0.4 to 8.9, which was 66% wider than the conventional interval. Bias analysis provides a more complete picture of true uncertainty than conventional frequentist statistical analysis accompanied by a qualitative description of study limitations. The latter approach is likely to lead to overconfidence regarding the potential for causal associations, whereas the former safeguards against such overinterpretations. Furthermore, such analyses, once programmed, allow rapid implementation of alternative assignments of probability distributions to the bias parameters, so elevate the plane of discussion regarding study bias from characterizing studies as "valid" or "invalid" to a critical and quantitative discussion of sources of uncertainty.

Dental responsibility loadings and the relative value of dental services.

PubMed

Teusner, D N; Ju, X; Brennan, D S

2017-09-01

To estimate responsibility loadings for a comprehensive list of dental services, providing a standardized unit of clinical work effort. Dentists (n = 2500) randomly sampled from the Australian Dental Association membership (2011) were randomly assigned to one of 25 panels. Panels were surveyed by questionnaires eliciting responsibility loadings for eight common dental services (core items) and approximately 12 other items unique to that questionnaire. In total, loadings were elicited for 299 items listed in the Australian Dental Schedule 9th Edition. Data were weighted to reflect the age and sex distribution of the workforce. To assess reliability, regression models assessed differences in core item loadings by panel assignment. Estimated loadings were described by reporting the median and mean. Response rate was 37%. Panel composition did not vary by practitioner characteristics. Core item loadings did not vary by panel assignment. Oral surgery and endodontic service areas had the highest proportion (91%) of services with median loadings ≥1.5, followed by prosthodontics (78%), periodontics (76%), orthodontics (63%), restorative (62%) and diagnostic services (31%). Preventive services had median loadings ≤1.25. Dental responsibility loadings estimated by this study can be applied in the development of relative value scales. © 2017 Australian Dental Association.

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

PubMed

Rhoades, Galena K

2015-12-01

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

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.

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.

On the mixing time of geographical threshold graphs

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

Bradonjic, Milan

In this paper, we study the mixing time of random graphs generated by the geographical threshold graph (GTG) model, a generalization of random geometric graphs (RGG). In a GTG, nodes are distributed in a Euclidean space, and edges are assigned according to a threshold function involving the distance between nodes as well as randomly chosen node weights. The motivation for analyzing this model is that many real networks (e.g., wireless networks, the Internet, etc.) need to be studied by using a 'richer' stochastic model (which in this case includes both a distance between nodes and weights on the nodes). Wemore » specifically study the mixing times of random walks on 2-dimensional GTGs near the connectivity threshold. We provide a set of criteria on the distribution of vertex weights that guarantees that the mixing time is {Theta}(n log n).« less

Effects of media violence on health-related outcomes among young men.

PubMed

Brady, Sonya S; Matthews, Karen A

2006-04-01

To test the effects of media violence exposure on blood pressure, negative affect, hostile social information processing, uncooperative behavior, and attitudes toward health risk behaviors among young men varying in lifetime violence exposure within the home and community. Experimental laboratory study. University campus situated within an urban environment. One hundred male undergraduates aged 18 to 21 years. Men who had previously reported differing amounts of lifetime home and community violence were randomly assigned to play The Simpsons: Hit and Run (low-violence condition) or Grand Theft Auto III (high-violence condition). Systolic and diastolic blood pressure; negative affect; hostile social information processing; uncooperative behavior; and permissive attitudes toward violence, alcohol use, marijuana use, and sexual activity without condom use. Men randomly assigned to play Grand Theft Auto III exhibited greater increases in diastolic blood pressure from a baseline rest period to game play, greater negative affect, more permissive attitudes toward using alcohol and marijuana, and more uncooperative behavior in comparison with men randomly assigned to play The Simpsons. Only among participants with greater exposure to home and community violence, play of Grand Theft Auto III led to elevated systolic blood pressure in comparison with play of The Simpsons (mean, 13 vs 5 mm Hg). Media violence exposure may play a role in the development of negative attitudes and behaviors related to health. Although youth growing up in violent homes and communities may become more physiologically aroused by media violence exposure, all youth appear to be at risk for potentially negative outcomes.

Intensive versus conventional glucose control in critically ill patients with traumatic brain injury: long-term follow-up of a subgroup of patients from the NICE-SUGAR study.

PubMed

Finfer, Simon; Chittock, Dean; Li, Yang; Foster, Denise; Dhingra, Vinay; Bellomo, Rinaldo; Cook, Deborah; Dodek, Peter; Hebert, Paul; Henderson, William; Heyland, Daren; Higgins, Alisa; McArthur, Colin; Mitchell, Imogen; Myburgh, John; Robinson, Bruce; Ronco, Juan

2015-06-01

To compare the effect of intensive versus conventional blood glucose control in patients with traumatic brain injury. In a large international randomized trial patients were randomly assigned to a target blood glucose (BG) range of either 4.5-6.0 mmol/L (intensive control) or <10 mmol/L (conventional control). Patients with traumatic brain injury (TBI) were identified at randomization and data were collected to examine the extended Glasgow outcome score (includes mortality) at 24 months. Of the 6104 randomized patients, 391 satisfied diagnostic criteria for TBI; 203 (51.9%) were assigned to intensive and 188 (48.1%) to conventional control; the primary outcome was available for 166 (81.8%) and 149 (79.3%) patients, respectively. The two groups had similar baseline characteristics. At 2 years 98 (58.7%) patients in the intensive group and 79 (53.0%) in the conventional group had a favorable neurological outcome (odds ratio [OR] 1.26, 95% CI 0.81-1.97; P = 0.3); 35 patients (20.9%) in the intensive group and 34 (22.8%) in the conventional group had died (OR 0.90, 95% CI 0.53-1.53; P = 0.7); moderate hypoglycemia (BG 2.3-3.9 mmol/L; 41-70 mg/dL) occurred in 160/202 (79.2%) and 17/188 (9.0%), respectively (OR 38.3, 95% CI 21.0-70.1; P < 0.0001); severe hypoglycemia (BG ≤ 2.2 mmol/L; ≤40 mg/dL) in 10 (4.9%) and 0 (0.0%), respectively (OR 20.5 95% CI 1.2-351.6, P = 0.003). Although patients with traumatic brain injury randomly assigned to intensive compared to conventional glucose control experienced moderate and severe hypoglycemia more frequently, we found no significant difference in clinically important outcomes.

Does a Culturally Sensitive Smoking Prevention Program Reduce Smoking Intentions among Aboriginal Children? A Pilot Study

ERIC Educational Resources Information Center

McKennitt, Daniel W.; Currie, Cheryl L.

2012-01-01

The aim of the study was to determine if a culturally sensitive smoking prevention program would have short-term impacts on smoking intentions among Aboriginal children. Two schools with high Aboriginal enrollment were selected for the study. A grade 4 classroom in one school was randomly assigned to receive the culturally sensitive smoking…

Identity Entrepreneurship and the Consequences of Identity Failure: The Dynamics of Leadership in the BBC Prison Study

ERIC Educational Resources Information Center

Haslam, S. Alexander; Reicher, Stephen

2007-01-01

The BBC Prison Study was an experimental case study in which participants were randomly assigned to groups as prisoners or guards. This paper examines the impact of interventions designed to increase prisoners' sense of shared social identity on processes of leadership. It presents psychometric, behavioral, and observational data which support the…

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

ERIC Educational Resources Information Center

Okyar, Hatice; Yangin Eksi, Gonca

2017-01-01

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

Effect of Self Regulated Learning Approach on Junior Secondary School Students' Achievement in Basic Science

ERIC Educational Resources Information Center

Nwafor, Chika E.; Obodo, Abigail Chikaodinaka; Okafor, Gabriel

2015-01-01

This study explored the effect of self-regulated learning approach on junior secondary school students' achievement in basic science. Quasi-experimental design was used for the study.Two co-educational schools were drawn for the study through simple random sampling technique. One school was assigned to the treatment group while the other was…

Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial.

PubMed

Schöffski, Patrick; Chawla, Sant; Maki, Robert G; Italiano, Antoine; Gelderblom, Hans; Choy, Edwin; Grignani, Giovanni; Camargo, Veridiana; Bauer, Sebastian; Rha, Sun Young; Blay, Jean-Yves; Hohenberger, Peter; D'Adamo, David; Guo, Matthew; Chmielowski, Bartosz; Le Cesne, Axel; Demetri, George D; Patel, Shreyaskumar R

2016-04-16

A non-randomised, phase 2 study showed activity and tolerability of eribulin in advanced or metastatic soft-tissue sarcoma. In this phase 3 study, we aimed to compare overall survival in patients with advanced or metastatic soft-tissue sarcoma who received eribulin with that in patients who received dacarbazine (an active control). We did this randomised, open-label, phase 3 study across 110 study sites in 22 countries. We enrolled patients aged 18 years or older with intermediate-grade or high-grade advanced liposarcoma or leiomyosarcoma who had received at least two previous systemic regimens for advanced disease (including an anthracycline). Using an interactive voice and web response system, an independent statistician randomly assigned (1:1) patients to receive eribulin mesilate (1·4 mg/m(2) intravenously on days 1 and 8) or dacarbazine (850 mg/m(2), 1000 mg/m(2), or 1200 mg/m(2) [dose dependent on centre and clinician] intravenously on day 1) every 21 days until disease progression. Randomisation was stratified by disease type, geographical region, and number of previous regimens for advanced soft-tissue sarcoma and in blocks of six. Patients and investigators were not masked to treatment assignment. The primary endpoint was overall survival in the intention-to-treat population. The study is registered with ClinicalTrials.gov, number NCT01327885, and is closed to recruitment, but treatment and follow-up continue. Between March 10, 2011 and May 22, 2013, we randomly assigned patients to eribulin (n=228) or dacarbazine (n=224). Overall survival was significantly improved in patients assigned to eribulin compared with those assigned to dacarbazine (median 13·5 months [95% CI 10·9-15·6] vs 11·5 months [9·6-13·0]; hazard ratio 0·77 [95% CI 0·62-0·95]; p=0·0169). Treatment-emergent adverse events occurred in 224 (99%) of 226 patients who received eribulin and 218 (97%) of 224 who received dacarbazine. Grade 3 or higher adverse events were more common in patients who received eribulin (152 [67%]) than in those who received dacarbazine (126 [56%]), as were deaths (10 [4%] vs 3 [1%]); one death (in the eribulin group) was considered treatment-related by the investigators. Overall survival was improved in patients assigned to eribulin compared with those assigned to an active control, suggesting that eribulin could be a treatment option for advanced soft-tissue sarcoma. Eisai. Copyright © 2016 Elsevier Ltd. All rights reserved.

Long-Term Effects of Strategic Reading Instruction in the Intermediate Elementary Grades

ERIC Educational Resources Information Center

Droop, Mienke; van Elsäcker, Willy; Voeten, Marinus J. M.; Verhoeven, Ludo

2016-01-01

The purpose of the present study was to examine the effects of a program that offered sustained strategic reading instruction on reading abilities of third and fourth graders. The study was conducted among 1,469 children from 40 schools in the Netherlands. Schools were randomly assigned to either the experimental or control group. Multilevel…

Metacognitive Scaffolds Improve Self-Judgments of Accuracy in a Medical Intelligent Tutoring System

ERIC Educational Resources Information Center

Feyzi-Behnagh, Reza; Azevedo, Roger; Legowski, Elizabeth; Reitmeyer, Kayse; Tseytlin, Eugene; Crowley, Rebecca S.

2014-01-01

In this study, we examined the effect of two metacognitive scaffolds on the accuracy of confidence judgments made while diagnosing dermatopathology slides in SlideTutor. Thirty-one (N = 31) first- to fourth-year pathology and dermatology residents were randomly assigned to one of the two scaffolding conditions. The cases used in this study were…

Predictors and Moderators of Treatment Outcome in the Pediatric Obsessive Compulsive Treatment Study (POTS I)

ERIC Educational Resources Information Center

Garcia, Abbe Marrs; Sapyta, Jeffrey J.; Moore, Phoebe S.; Freeman, Jennifer B.; Franklin, Martin E.; March, John S.; Foa, Edna B.

2010-01-01

Objective: To identify predictors and moderators of outcome in the first Pediatric OCD Treatment Study (POTS I) among youth (N = 112) randomly assigned to sertraline, cognitive behavioral therapy (CBT), both sertraline and CBT (COMB), or a pill placebo. Method: Potential baseline predictors and moderators were identified by literature review. The…

The Hard but Necessary Task of Gathering Order-One Effect Size Indices in Meta-Analysis

ERIC Educational Resources Information Center

Ortego, Carmen; Botella, Juan

2010-01-01

Meta-analysis of studies with two groups and two measurement occasions must employ order-one effect size indices to represent study outcomes. Especially with non-random assignment, non-equivalent control group designs, a statistical analysis restricted to post-treatment scores can lead to severely biased conclusions. The 109 primary studies…

Using Advance Organizers to Enhance Pupils' Achievement in Learning Poetry in English Language

ERIC Educational Resources Information Center

Muiruri, Mary; Wambugu, Patriciah; Wamukuru, Kuria

2016-01-01

The study was a quasi-experimental that investigated the effects of Advance Organizers (AO) on achievement in poetry. Target population was class seven pupils of Nakuru North Sub-county primary schools in Kenya. 160 pupils were involved in the study. Four sampled schools were randomly assigned to control and experimental groups in Solomon Four…

An Exploratory Study of Universal Design for Teaching Chemistry to Students with and without Disabilities

ERIC Educational Resources Information Center

King-Sears, Margaret E.; Johnson, Todd M.; Berkeley, Sheri; Weiss, Margaret P.; Peters-Burton, Erin E.; Evmenova, Anya S.; Menditto, Anna; Hursh, Jennifer C.

2015-01-01

In this exploratory study, students in four co-taught high school chemistry classes were randomly assigned to a Universal Design for Learning (UDL) treatment or a comparison condition. Each co-teaching team taught one comparison and treatment class. UDL principles were operationalized for treatment: (a) a self-management strategy (using a…

Benefits of Early Childhood Interventions across the World: (Under) Investing in the Very Young

ERIC Educational Resources Information Center

Nores, Milagros; Barnett, W. Steven

2010-01-01

This paper reviews the international (non-U.S.) evidence on the benefits of early childhood interventions. A total of 38 contrasts of 30 interventions in 23 countries were analyzed. It focuses on studies applying a quasi-experimental or random assignment. Studies were coded according to: the type of intervention (cash transfer, nutritional,…

Effects of Risperidone on Cognitive-Motor Performance and Motor Movements in Chronically Medicated Children

ERIC Educational Resources Information Center

Aman, Michael G.; Hollway, Jill A.; Leone, Sarah; Masty, Jessica; Lindsay, Ronald; Nash, Patricia; Arnold, L. Eugene

2009-01-01

This study was designed to explore the placebo-controlled effects of risperidone on cognitive-motor processes, dyskinetic movements, and behavior in children receiving maintenance risperidone therapy. Sixteen children aged 4-14 years with disruptive behavior were randomly assigned to drug order in a crossover study of risperidone and placebo for 2…

The Effect of Content-Focused Coaching on the Quality of Classroom Text Discussions

ERIC Educational Resources Information Center

Matsumura, Lindsay Clare; Garnier, Helen E.; Spybrook, Jessaca

2012-01-01

This study examines the effect of a comprehensive literacy-coaching program focused on enacting a discussion-based approach to reading comprehension instruction (content-focused coaching [CFC]) on the quality of classroom text discussions over 2 years. The study used a cluster-randomized trial in which schools were assigned to either CFC or…

An Experimental Study Comparing English-Only and Transitional Bilingual Education on Spanish-Speaking Preschoolers' Early Literacy Development

ERIC Educational Resources Information Center

Duran, Lillian K.; Roseth, Cary J.; Hoffman, Patricia

2010-01-01

A longitudinal, experimental-control design was used to test the hypothesis that native language instruction enhances English language learner's (ELL's) native language and literacy development without significant cost to English development. In this study, 31 Spanish-speaking preschoolers (aged 38-48 months) were randomly assigned to two Head…

The Impact of Concept Mapping on EFL Learners' Critical Thinking Ability

ERIC Educational Resources Information Center

Khodadady, Ebrahim; Ghanizadeh, Afsaneh

2011-01-01

The present study investigated the influence of concept mapping as a post-reading strategy on EFL learners' critical thinking ability. The study utilized a pretest-posttest control and experimental group design. To do so, thirty six EFL learners at upper intermediate and advanced levels were randomly assigned to experimental (n=18) and control…

Word Processor versus "The Pencil" Effects on Writing.

ERIC Educational Resources Information Center

Schanck, Emily T.

In a study to determine the effects of writing on the computer versus traditional writing by hand, 22 fourth grade students were randomly assigned to samples using either a computer or paper and pencil. The study hypothesized that (1) children are not more willing to revise and improve their writing using a word processor when compared to the…

The Cheer Study to Reduce BMI in Elementary School Students: A School-Based, Parent-Directed Study in Framingham, Massachusetts

ERIC Educational Resources Information Center

Resnick, Elissa A.; Bishop, Marilyn; O'Connell, Anne; Hugo, Beverly; Isern, Germinal; Timm, Alison; Ozonoff, Al; Geller, Alan C.

2009-01-01

Childhood obesity may be lessened by parent-focused interventions. A pilot parent-directed trial with 46 parents of overweight and obese elementary school students was conducted at two ethnically diverse public schools in Framingham, Massachusetts. Parents were randomly assigned to either the Materials Group, which received mailed educational…

Fit between Future Thinking and Future Orientation on Creative Imagination

ERIC Educational Resources Information Center

Chiu, Fa-Chung

2012-01-01

The purpose of the current study is to investigate the impact of future thinking, and the fit between future thinking and future orientation on creative thinking. In Study 1, 83 undergraduates were randomly assigned to three groups: 50-year future thinking, 5-year future thinking, and the present-day thinking. First, the priming tasks, in which…

The Effects of Different Pre-Writing Strategies on Iranian EFL Writing Achievement

ERIC Educational Resources Information Center

Mahnam, Lily; Nejadansari, Dariush

2012-01-01

This study aimed at investigating whether applying pre-writing strategies would affect the quality of L2 learners' compositions. Twenty three adult EFL students from Jahad-e-Daneshgahi English centre in Iran participated in this study. They were randomly assigned to control and experimental groups, including 11 and 12 participants in each. They…

Effects of Multimedia Annotations on Incidental Vocabulary Learning and Reading Comprehension of Advanced Learners of English as a Foreign Language

ERIC Educational Resources Information Center

Akbulut, Yavuz

2007-01-01

The study investigates immediate and delayed effects of different hypermedia glosses on incidental vocabulary learning and reading comprehension of advanced foreign language learners. Sixty-nine freshman TEFL students studying at a Turkish university were randomly assigned to three types of annotations: (a) definitions of words, (b) definitions…

The Sustained Impact of Teacher Encouragement on Elementary Students' Vegetable Snack Consumption: Initial Findings from a Wisconsin Study

ERIC Educational Resources Information Center

Jamelske, Eric M.; Vernon, Erin

2018-01-01

Purpose/Objectives: The purpose of this study was to determine the impact of teacher encouragement on elementary school student vegetable snack consumption. Methods: Twelve Wisconsin elementary school teachers were randomly assigned different levels of encouragement procedures during vegetable snack time. The consumption levels of 218 students…

Effects of Psychomotor Intervention Program on Students with Autism Spectrum Disorder

ERIC Educational Resources Information Center

ElGarhy, Sayed; Liu, Ting

2016-01-01

The purpose of this study was to examine the effects of a psychomotor intervention program (PIP) on body awareness and psychomotor concepts for students with autism spectrum disorder (ASD). Twenty-eight students (23 boys and 5 girls) with ASD participated in this study. Fourteen students with ASD were randomly assigned to the experimental group…

Young Children with a Positive Reputation to Maintain Are Less Likely to Cheat

ERIC Educational Resources Information Center

Fu, Genyue; Heyman, Gail D.; Qian, Miao; Guo, Tengfei; Lee, Kang

2016-01-01

The present study examined whether having a positive reputation to maintain makes young children less likely to cheat. Cheating was assessed through a temptation resistance paradigm in which participants were instructed not to cheat in a guessing game. Across three studies (total N = 361), preschool-aged participants were randomly assigned to…

The Effect of Choosing versus Receiving Feedback on College Students' Performance

ERIC Educational Resources Information Center

Cutumisu, Maria; Schwartz, Daniel L.

2016-01-01

This study examines the effect of choosing versus receiving feedback on the learning performance of n = 98 post-secondary students from California on a digital poster design task. The study employs a yoked experimental design where college students are randomly assigned to play a choice-based assessment game, Posterlet, in one of two conditions,…

Mediating Role of Parental Influence in Children's Response to Television Commercials: An Exploratory Study.

ERIC Educational Resources Information Center

Prasad, V. Kanti; And Others

This study investigated, in a laboratory experimental framework, the relative influences of television commercials and parental counter-commercial advocacy on children's consumption choice behavior. Sixty-four 8- to 10-year-old boys were randomly assigned to one of three treatment groups: (1) no counter commercial advocacy (control group), (2)…

Effect of Ethnochemistry Practices on Secondary School Students' Attitude towards Chemistry

ERIC Educational Resources Information Center

Singh, Indra Sen; Chibuye, Bitwell

2016-01-01

The main purpose of the study was to find out the effect of ethnochemistry practices on secondary school students' attitude towards Chemistry. The design of the study was pre-test post-test control group quasiexperimental design. Two grade 11 intact classes were assigned into experimental and control groups randomly. The total sample size…

Technology Instructional Package Mediated Instruction and Senior Secondary School Students' Academic Performance in Biology Concepts

ERIC Educational Resources Information Center

Yaki, Akawo Angwal; Babagana, Mohammed

2016-01-01

The paper examined the effects of a Technological Instructional Package (TIP) on secondary school students' performance in biology. The study adopted a pre-test, post-test experimental control group design. The sample size of the study was 80 students from Minna metropolis, Niger state, Nigeria; the samples were randomly assigned into treatment…

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

ERIC Educational Resources Information Center

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

2014-01-01

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

The Use of Targeted Pitch Skills for Sight-Singing Instruction in the Choral Rehearsal

ERIC Educational Resources Information Center

Henry, Michele L.

2004-01-01

The purpose of this study was to determine the effectiveness of sight-singing instruction using specific pitch skills emphasizing scale degree and harmonic function. Fifteen pitch skills encompassing scalar, cadential, and chordal tasks were included in the study. Over a 12-week period, two randomly assigned groups of novice high school singers…

An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies

ERIC Educational Resources Information Center

Austin, Peter C.

2011-01-01

The propensity score is the probability of treatment assignment conditional on observed baseline characteristics. The propensity score allows one to design and analyze an observational (nonrandomized) study so that it mimics some of the particular characteristics of a randomized controlled trial. In particular, the propensity score is a balancing…

Promoting Language and Literacy Development for Early Childhood Educators: A Mixed-Methods Study of Coursework and Coaching

ERIC Educational Resources Information Center

Neuman, Susan B.; Wright, Tanya S.

2010-01-01

This study examines the impact of 2 forms of professional development on prekindergarten teachers' early language and literacy practice: coursework and coaching. Participating teachers (N = 148) from 6 urban cities were randomly assigned to Group 1 (coursework), Group 2 (on-site coaching), or Group 3 (control group). Pre- and postassessments…

Readers, Players, and Watchers: EFL Students' Vocabulary Acquisition through Digital Video Games

ERIC Educational Resources Information Center

Ebrahimzadeh, Mohsen

2017-01-01

The present study investigated vocabulary acquisition through a commercial digital video game compared to a traditional pencil-and-paper treatment. Chosen through cluster sampling, 241 male high school students (age 12-18) participated in the study. They were randomly assigned to one of the following groups. The first group, called Readers,…

Can Personalized Nudges Improve Learning in Hybrid Classes? Experimental Evidence from an Introductory Undergraduate Course

ERIC Educational Resources Information Center

O'Connell, Stephen D.; Lang, Guido

2018-01-01

A field experiment was conducted to investigate whether personalized e-mail reminders can improve study consistency and learning outcomes in an introductory-level undergraduate course. By randomly assigning whether nearly 300 students would receive occasional e-mail messages encouraging out-of-class study, we find that these reminders increased…

Cost-Effectiveness of Case Management in Substance Abuse Treatment

ERIC Educational Resources Information Center

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

2006-01-01

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

Exposure to Metacognitive Skills Improves Academic Performance: An Experimental Study of College Students' Academic Performance and Self-Efficacy

ERIC Educational Resources Information Center

Thomas, Pamela

2016-01-01

This study examined undergraduate students in four randomly assigned groups, Generative Reading, SQ3R (Robinson, (1946, 1970), and no intervention, and general examinations as the control, to identify which strategy was most beneficial for improving exam scores and academic self-efficacy. Findings suggest students participating in reading…

Effects of Field Instructor Training on Student Competencies and the Supervisory Alliance

ERIC Educational Resources Information Center

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

2011-01-01

Objectives: This study of a field instructor (FI) training model, offered at two universities, focused on the relationship between student competencies, the supervisory alliance, and students' attachment styles. Method: The study used a pretest-posttest follow-up design of 100 randomly assigned FIs (training group = 48; control group = 52) and 64…

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

ERIC Educational Resources Information Center

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

2015-01-01

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

Guided Imagery and Relaxation for Women with Early Stage Breast Cancer

ERIC Educational Resources Information Center

Goodwin, Linda K.; Lee, Sang Min; Puig, Ana I.; Sherrard, Peter A. D.

2005-01-01

Fifty-two women with Stage I and Stage II breast cancer agreed to participate in a study to determine the effectiveness of two interventions, guided imagery and relaxation, to enhance psychological well-being. Participants were randomly assigned to either a guided imagery or relaxation group. Forty women completed the study. A student's t-test was…

Parent-Reported Homework Problems in the MTA Study: Evidence for Sustained Improvement with Behavioral Treatment

ERIC Educational Resources Information Center

Langberg, Joshua M.; Arnold, L. Eugene; Flowers, Amanda M.; Epstein, Jeffery N.; Altaye, Mekibib; Hinshaw, Stephen P.; Swanson, James M.; Kotkin, Ronald; Simpson, Stephen; Molina, Brooke S. G.; Jensen, Peter S.; Abikoff, Howard; Pelham, William E., Jr.; Vitiello, Benedetto; Wells, Karen C.; Hechtman, Lily

2010-01-01

Parent-report of child homework problems was examined as a treatment outcome variable in the MTA-Multimodal Treatment Study of Children with Attention-Deficit/Hyperactivity Disorder (ADHD). Five hundred seventy-nine children ages 7.0 to 9.9 were randomly assigned to either medication management, behavioral treatment, combination treatment, or…

Cross-Age Peer Tutors in Asynchronous Discussion Groups: Studying the Impact of Tutors Labelling Their Interventions

ERIC Educational Resources Information Center

De Smet, M.; Van Keer, H.; Valcke, M.

2008-01-01

Cross-age tutors were randomly assigned to one of the three tutor training conditions distinguished for the current study: (1) the labelling experimental condition, characterized by requirements to label their tutor interventions, based on the e-moderating model of Salmon; (2) the non-labelling experimental condition, focusing on tutor's acting…

Prediction Accuracy: The Role of Feedback in 6th Graders' Recall Predictions

ERIC Educational Resources Information Center

Al-Harthy, Ibrahim S.

2016-01-01

The current study focused on the role of feedback on students' prediction accuracy (calibration). This phenomenon has been widely studied, but questions remain about how best to improve it. In the current investigation, fifty-seven students from sixth grade were randomly assigned to control and experimental groups. Thirty pictures were chosen from…

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:…

Group Counseling With Emotionally Disturbed School Children in Taiwan.

ERIC Educational Resources Information Center

Chiu, Peter

The application of group counseling to emotionally disturbed school children in Chinese culture was examined. Two junior high schools located in Tao-Yuan Province were randomly selected with two eighth-grade classes randomly selected from each school. Ten emotionally disturbed students were chosen from each class and randomly assigned to two…

Sample Selection in Randomized Experiments: A New Method Using Propensity Score Stratified Sampling

ERIC Educational Resources Information Center

Tipton, Elizabeth; Hedges, Larry; Vaden-Kiernan, Michael; Borman, Geoffrey; Sullivan, Kate; Caverly, Sarah

2014-01-01

Randomized experiments are often seen as the "gold standard" for causal research. Despite the fact that experiments use random assignment to treatment conditions, units are seldom selected into the experiment using probability sampling. Very little research on experimental design has focused on how to make generalizations to well-defined…

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

ERIC Educational Resources Information Center

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

2016-01-01

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

Randomized Clinical Trial Replication of a Psychosocial Treatment for Children with High-Functioning Autism Spectrum Disorders

ERIC Educational Resources Information Center

Thomeer, Marcus L.; Lopata, Christopher; Volker, Martin A.; Toomey, Jennifer A.; Lee, Gloria K.; Smerbeck, Audrey M.; Rodgers, Jonathan D.; McDonald, Christin A.; Smith, Rachael A.

2012-01-01

This replication randomized clinical trial examined the efficacy of a comprehensive psychosocial intervention for children aged 7 to 12 years with high-functioning autism spectrum disorders (HFASDs). Participants were randomly assigned to treatment or wait-list conditions. Treatment included instruction and therapeutic activities targeting social…

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.

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

PubMed

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

2013-01-01

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

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.

The Phosphate Binder Ferric Citrate and Mineral Metabolism and Inflammatory Markers in Maintenance Dialysis Patients: Results From Prespecified Analyses of a Randomized Clinical Trial

PubMed Central

Van Buren, Peter N.; Lewis, Julia B.; Dwyer, Jamie P.; Greene, Tom; Middleton, John; Sika, Mohammed; Umanath, Kausik; Abraham, Josephine D.; Arfeen, Shahabul S.; Bowline, Isai G.; Chernin, Gil; Fadem, Stephen Z.; Goral, Simin; Koury, Mark; Sinsakul, Marvin V.; Weiner, Daniel E.

2016-01-01

Background Phosphate binders are the cornerstone of hyperphosphatemia management in dialysis patients. Ferric citrate is an iron-based oral phosphate binder that effectively lowers serum phosphorus levels. Study Design 52-week, open-label, phase 3, randomized, controlled trial for safety-profile assessment. Setting & Participants Maintenance dialysis patients with serum phosphorus levels ≥6.0 mg/dL after washout of prior phosphate binders. Intervention 2:1 randomization to ferric citrate or active control (sevelamer carbonate and/or calcium acetate). Outcomes Changes in mineral bone disease, protein-energy wasting/inflammation, and occurrence of adverse events after 1 year. Measurements Serum calcium, intact parathyroid hormone, phosphorus, aluminum, white blood cell count, percentage of lymphocytes, serum urea nitrogen, and bicarbonate. Results There were 292 participants randomly assigned to ferric citrate, and 149, to active control. Groups were well matched. For mean changes from baseline, phosphorus levels decreased similarly in the ferric citrate and active control groups (−2.04 ± 1.99 [SD] vs −2.18 ± 2.25 mg/dL, respectively; P = 0.9); serum calcium levels increased similarly in the ferric citrate and active control groups (0.22 ± 0.90 vs 0.31 ± 0.95 mg/dL; P = 0.2). Hypercalcemia occurred in 4 participants receiving calcium acetate. Parathyroid hormone levels decreased similarly in the ferric citrate and active control groups (−167.1 ± 399.8 vs −152.7 ± 392.1 pg/mL; P = 0.8). Serum albumin, bicarbonate, serum urea nitrogen, white blood cell count and percentage of lymphocytes, and aluminum values were similar between ferric citrate and active control. Total and low-density lipoprotein cholesterol levels were lower in participants receiving sevelamer than those receiving ferric citrate and calcium acetate. Fewer participants randomly assigned to ferric citrate had serious adverse events compared with active control. Limitations Open-label study, few peritoneal dialysis patients. Conclusions Ferric citrate was associated with similar phosphorus control compared to active control, with similar effects on markers of bone and mineral metabolism in dialysis patients. There was no evidence of protein-energy wasting/inflammation or aluminum toxicity, and fewer participants randomly assigned to ferric citrate had serious adverse events. Ferric citrate is an effective phosphate binder with a safety profile comparable to sevelamer and calcium acetate. PMID:25958079

Alternative Goal Structures for Computer Game-Based Learning

ERIC Educational Resources Information Center

Ke, Fengfeng

2008-01-01

This field study investigated the application of cooperative, competitive, and individualistic goal structures in classroom use of computer math games and its impact on students' math performance and math learning attitudes. One hundred and sixty 5th-grade students were recruited and randomly assigned to Teams-Games-Tournament cooperative gaming,…