A Randomized Field Trial of the Fast ForWord Language Computer-Based Training Program

ERIC Educational Resources Information Center

Borman, Geoffrey D.; Benson, James G.; Overman, Laura

2009-01-01

This article describes an independent assessment of the Fast ForWord Language computer-based training program developed by Scientific Learning Corporation. Previous laboratory research involving children with language-based learning impairments showed strong effects on their abilities to recognize brief and fast sequences of nonspeech and speech…

Project EX: A Program of Empirical Research on Adolescent Tobacco Use Cessation

PubMed Central

Sussman, Steve; McCuller, William J; Zheng, Hong; Pfingston, Yvonne M; Miyano, James; Dent, Clyde W

2004-01-01

This paper presents the Project EX research program. The historical background for Project EX is presented, including a brief summary of reasons youth fail to quit tobacco use, the disappointing status of previous cessation research, and the teen cessation trial that provided the template for the current project (Project TNT). Next, program development studies for Project EX are described. Through use of focus groups, a theme study (concept evaluation of written activity descriptions), a component study, and pilot studies, an eight-session program was developed. This program involves novel activities (e.g., "talk show enactments," games, and alternative medicine-type activities such as yoga and meditation) in combination with motivation enhancement and cognitive-behavioral strategies to motivate and instruct in cessation initiation and maintenance efforts. The outcomes of the first experimental trial of Project EX, a school-based clinic program, are described, followed by a posthoc analysis of its effects mediation. A second EX study, a multiple baseline single group pilot study design in Wuhan, China, is described next. Description of a second experimental trial follows, which tested EX with nicotine gum versus a natural herb. A third experimental trial that tests a classroom prevention/cessation version of EX is then introduced. Finally, the implications of this work are discussed. The intent-to-treat quit rate for Project EX is approximately 15% across studies, double that of a standard care comparison. Effects last up to a six-month post-program at regular and alternative high schools. Through a systematic protocol of empirical program development and field trials, an effective and replicable model teen tobacco use cessation program is established. Future cessation work might expand on this work.

Project EX: A Program of Empirical Research on Adolescent Tobacco Use Cessation

PubMed Central

Sussman, Steve; McCuller, William J; Zheng, Hong; Pfingston, Yvonne M; Miyano, James; Dent, Clyde W

2004-01-01

This paper presents the Project EX research program. The historical background for Project EX is presented, including a brief summary of reasons youth fail to quit tobacco use, the disappointing status of previous cessation research, and the teen cessation trial that provided the template for the current project (Project TNT). Next, program development studies for Project EX are described. Through use of focus groups, a theme study (concept evaluation of written activity descriptions), a component study, and pilot studies, an eight-session program was developed. This program involves novel activities (e.g., "talk show enactments," games, and alternative medicine-type activities such as yoga and meditation) in combination with motivation enhancement and cognitive-behavioral strategies to motivate and instruct in cessation initiation and maintenance efforts. The outcomes of the first experimental trial of Project EX, a school-based clinic program, are described, followed by a posthoc analysis of its effects mediation. A second EX study, a multiple baseline single group pilot study design in Wuhan, China, is described next. Description of a second experimental trial follows, which tested EX with nicotine gum versus a natural herb. A third experimental trial that tests a classroom prevention/cessation version of EX is then introduced. Finally, the implications of this work are discussed. The intent-to-treat quit rate for Project EX is approximately 15% across studies, double that of a standard care comparison. Effects last up to a six-month post-program at regular and alternative high schools. Through a systematic protocol of empirical program development and field trials, an effective and replicable model teen tobacco use cessation program is established. Future cessation work might expand on this work. PMID:19570278

Gene Therapy in Cardiac Surgery: Clinical Trials, Challenges, and Perspectives

PubMed Central

Katz, Michael G.; Fargnoli, Anthony S.; Kendle, Andrew P.; Hajjar, Roger J.; Bridges, Charles R.

2016-01-01

The concept of gene therapy was introduced in the 1970s after the development of recombinant DNA technology. Despite the initial great expectations, this field experienced early setbacks. Recent years have seen a revival of clinical programs of gene therapy in different fields of medicine. There are many promising targets for genetic therapy as an adjunct to cardiac surgery. The first positive long-term results were published for adenoviral administration of vascular endothelial growth factor with coronary artery bypass grafting. In this review we analyze the past, present, and future of gene therapy in cardiac surgery. The articles discussed were collected through PubMed and from author experience. The clinical trials referenced were found through the Wiley clinical trial database (http://www.wiley.com/legacy/wileychi/genmed/clinical/) as well as the National Institutes of Health clinical trial database (Clinicaltrials.gov). PMID:26801060

Grades of Evidence: Variability in Quality of Findings in Effectiveness Studies of Complex Field Interventions

ERIC Educational Resources Information Center

Chatterji, Madhabi

2007-01-01

This article argues with a literature review that a simplistic distinction between strong and weak evidence hinged on the use of randomized controlled trials (RCTs), the federal "gold standard" for generating rigorous evidence on social programs and policies, is not tenable with evaluative studies of complex, field interventions such as…

OPTIMIZATION OF MUD HAMMER DRILLING PERFORMANCE - A PROGRAM TO BENCHMARK THE VIABILITY OF ADVANCED MUD HAMMER DRILLING

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

Arnis Judzis

2002-10-01

This document details the progress to date on the OPTIMIZATION OF MUD HAMMER DRILLING PERFORMANCE -- A PROGRAM TO BENCHMARK THE VIABILITY OF ADVANCED MUD HAMMER DRILLING contract for the quarter starting July 2002 through September 2002. Even though we are awaiting the optimization portion of the testing program, accomplishments include the following: (1) Smith International agreed to participate in the DOE Mud Hammer program. (2) Smith International chromed collars for upcoming benchmark tests at TerraTek, now scheduled for 4Q 2002. (3) ConocoPhillips had a field trial of the Smith fluid hammer offshore Vietnam. The hammer functioned properly, though themore » well encountered hole conditions and reaming problems. ConocoPhillips plan another field trial as a result. (4) DOE/NETL extended the contract for the fluid hammer program to allow Novatek to ''optimize'' their much delayed tool to 2003 and to allow Smith International to add ''benchmarking'' tests in light of SDS Digger Tools' current financial inability to participate. (5) ConocoPhillips joined the Industry Advisors for the mud hammer program. (6) TerraTek acknowledges Smith International, BP America, PDVSA, and ConocoPhillips for cost-sharing the Smith benchmarking tests allowing extension of the contract to complete the optimizations.« less

Educational Technology Program. Quarterly Technical Summary, 1 March - 31 May 1972.

ERIC Educational Resources Information Center

Frick, Frederick C.

The results of the field trials of the Lincoln Training System (LTS-3) program are summarized in this report. The LTS-3 system was designed to teach basic electronics to Air Force personnel at Kessler Air Force Base, Mississippi. The results indicated that the instructional delays due to system failure were minimal, and those failures were…

Study protocol for a group randomized controlled trial of a classroom-based intervention aimed at preventing early risk factors for drug abuse: integrating effectiveness and implementation research.

PubMed

Poduska, Jeanne; Kellam, Sheppard; Brown, C Hendricks; Ford, Carla; Windham, Amy; Keegan, Natalie; Wang, Wei

2009-09-02

While a number of preventive interventions delivered within schools have shown both short-term and long-term impact in epidemiologically based randomized field trials, programs are not often sustained with high-quality implementation over time. This study was designed to support two purposes. The first purpose was to test the effectiveness of a universal classroom-based intervention, the Whole Day First Grade Program (WD), aimed at two early antecedents to drug abuse and other problem behaviors, namely, aggressive, disruptive behavior and poor academic achievement. The second purpose--the focus of this paper--was to examine the utility of a multilevel structure to support high levels of implementation during the effectiveness trial, to sustain WD practices across additional years, and to train additional teachers in WD practices. The WD intervention integrated three components, each previously tested separately: classroom behavior management; instruction, specifically reading; and family-classroom partnerships around behavior and learning. Teachers and students in 12 schools were randomly assigned to receive either the WD intervention or the standard first-grade program of the school system (SC). Three consecutive cohorts of first graders were randomized within schools to WD or SC classrooms and followed through the end of third grade to test the effectiveness of the WD intervention. Teacher practices were assessed over three years to examine the utility of the multilevel structure to support sustainability and scaling-up. The design employed in this trial appears to have considerable utility to provide data on WD effectiveness and to inform the field with regard to structures required to move evidence-based programs into practice. NCT00257088.

Machine on Trial

DTIC Science & Technology

2012-06-01

executed a concerted effort to employ reliability standards and testing from the design phase through fielding. Reliability programs remain standard...performed flight test engineer duties on several developmental flight test programs and served as Chief Engineer for a flight test squadron. Major...Quant is an acquisition professional with over 250 flight test hours in various aircraft, including the F-16, Airborne Laser, and HH-60. She holds a

The effect of static scanning and mobility training on mobility in people with hemianopia after stroke: A randomized controlled trial comparing standardized versus non-standardized treatment protocols

PubMed Central

2011-01-01

Background Visual loss following stroke impacts significantly on activities of daily living and is an independent risk factor for becoming dependent. Routinely, allied health clinicians provide training for visual field loss, mainly with eye movement based therapy. The effectiveness of the compensatory approach to rehabilitation remains inconclusive largely due to difficulty in validating functional outcome with the varied type and dosage of therapy received by an individual patient. This study aims to determine which treatment is more effective, a standardized approach or individualized therapy in patients with homonymous hemianopia post stroke. Methods/Design This study is a double-blind randomized controlled, multicenter trial. A standardised scanning rehabilitation program (Neuro Vision Technology (NVT) program) of 7 weeks at 3 times per week, is compared to individualized therapy recommended by clinicians. Discussion The results of the trial will provide information that could potentially inform the allocation of resources in visual rehabilitation post stroke. Trial Registration Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12610000494033 PMID:21767413

A school-based program implemented by community providers previously trained for the prevention of eating and weight-related problems in secondary-school adolescents: the MABIC study protocol.

PubMed

Sánchez-Carracedo, David; López-Guimerà, Gemma; Fauquet, Jordi; Barrada, Juan Ramón; Pàmias, Montserrat; Puntí, Joaquim; Querol, Mireia; Trepat, Esther

2013-10-12

The prevention of eating disorders and disordered eating are increasingly recognized as public health priorities. Challenges in this field included moving from efficacy to effectiveness and developing an integrated approach to the prevention of a broad spectrum of eating and weight-related problems. A previous efficacy trial indicated that a universal disordered eating prevention program, based on the social cognitive model, media literacy educational approach and cognitive dissonance theory, reduced risk factors for disordered eating, but it is unclear whether this program has effects under more real-world conditions. The main aim of this effectiveness trial protocol is to test whether this program has effects when incorporating an integrated approach to prevention and when previously-trained community providers implement the intervention. The research design involved a multi-center non-randomized controlled trial with baseline, post and 1-year follow-up measures. Six schools from the city of Sabadell (close to Barcelona) participated in the intervention group, and eleven schools from four towns neighboring Sabadell participated in the control group. A total of 174 girls and 180 boys in the intervention group, and 484 girls and 490 boys in the control group were registered in class lists prior to baseline. A total of 18 community providers, secondary-school class tutors, nurses from the Catalan Government's Health and School Program, and health promotion technicians from Sabadell City Council were trained and delivered the program. Shared risk factors of eating and weight-related problems were assessed as main measures. It will be vital for progress in disordered eating prevention to conduct effectiveness trials, which test whether interventions are effective when delivered by community providers under ecologically valid conditions, as opposed to tightly controlled research trials. The MABIC project will provide new contributions in this transition from efficacy to effectiveness and new data about progress in the integrated approach to prevention. Pending the results, the effectiveness trial meets the effectiveness standards set down by the Society for Prevention Research. This study will provide new evidence to improve and enhance disordered eating prevention programs. Current Controlled Trials ISRCTN47682626.

Residents-as-teachers programs in psychiatry: a systematic review.

PubMed

Dewey, Charlene M; Coverdale, John H; Ismail, Nadia J; Culberson, John W; Thompson, Britta M; Patton, Cynthia S; Friedland, Joan A

2008-02-01

Because psychiatry residents have important roles as teachers and significant opportunities to contribute to medical student education, we set out to: identify all randomized control trials (RCT) for residents' teaching skills programs in psychiatry and to identify the efficacy of those interventions for improving teaching skills; identify the strengths and weaknesses of the available studies across medical disciplines; and identify currently available methods for enhancing residents' teaching skills for residents training in psychiatry. The published English-language literature was searched using PubMed, Social Sciences Index, and PsycINFO databases, with key search words including: residents, teaching skills, residents as teachers, psychiatry, and assessments. Both RCT and controlled, nonrandomized trials of residents' teaching programs directed to enhance residents' teaching skills were selected and critically appraised. Of 13 trials identified and reviewed, most included residents in internal medicine. Only one included psychiatry residents and assessed their ability to teach interviewing skills to medical students. Along with other studies, this study demonstrated improvement in residents' teaching skills. Overall, interventions and outcome measures were heterogeneous while the quality of methodologies varied. Five studies were of higher quality, representing examples of quality educational research. Several described group differences, blinding, good follow-up, and use of valid, reliable tools. Only one trial exists that incorporated psychiatry residents. Significant opportunity to advance educational research in this field exists. Psychiatry residency program directors should incorporate high-quality methodologies and can benefit from the findings of trials in other disciplines.

Effectiveness of vocational rehabilitation intervention on the return to work and employment of persons with multiple sclerosis.

PubMed

Khan, Fary; Ng, Louisa; Turner-Stokes, Lynne

2009-01-21

Multiple sclerosis is a neurological disease that frequently affects adults of working age, resulting in a range of physical, cognitive and psychosocial deficits that impact on workforce participation. Although, the literature supports vocational rehabilitation (VR) approaches in persons with multiple sclerosis (pwMS), the evidence for its effectiveness is yet to be established. To evaluate the effectiveness of VR programs compared to alternative programs or care as usual on return to work, workability and employment in pwMS; to evaluate the cost effectiveness of these programs. Electronic searches included: Cochrane Central Register of Controlled Trials "CENTRAL" 2008 issue 3, MEDLINE (PubMed) (1966- 2008), EMBASE (1988- 2008), CINAHL (1982- 2008), PEDro (1990- 2008), the Cochrane Rehabilitation and Related Therapies Field trials Register and the National Health Service National Research Register. Randomized and controlled clinical trials, including before - after controlled trials, that compare VR rehabilitation with alternative intervention such as standard or a lesser form of intervention or waitlist controls. Two reviewers selected trials and rated their methodological quality independently. A 'best evidence' synthesis was performed, based on methodological quality. Trials were grouped in terms of type and setting of VR programs. Two trials (one RCT and one CCT) (total 80 participants) met the review criteria. Both trials scored poorly on the methodological quality assessment. There was 'insufficient evidence' for VR programs for (a)'competitive employment', in altering rates of job retention, changes in employment, improvement in rates of re-entry into the labour force; (b) for altering 'work ability' by improving participants' confidence in the accommodation request process, or employability maturity or job seeking activity. No evidence could be assimilated for changes in proportions of persons in supported employment or on disability pensions, nor for cost-effectiveness. There was inconclusive evidence to support VR for pwMS. However, the review highlights some of the challenges in providing VR for pwMS. Clinicians need to be aware of vocational issues, and to understand and manage barriers for maintaining employment. Proactive and timely VR programs should incorporate practical solutions to deal with work disability, workplace accommodation and educate employers, and the wider community. Liaison with policy makers is imperative for government initiatives that encourage work focused VR programs. Future research in VR should focus on improving methodological and scientific rigour of clinical trials; on the development of appropriate and valid outcome measures; and on cost effectiveness of VR programs.

First satellite mobile communication trials using BLQS-CDMA

NASA Technical Reports Server (NTRS)

Luzdemateo, Maria; Johns, Simon; Dothey, Michel; Vanhimbeeck, Carl; Deman, Ivan; Wery, Bruno

1993-01-01

In this paper, technical results obtained in the first MSBN Land mobile technical trial are reported. MSBN (Mobile Satellite Business Network) is a new program undertaken by the European Space Agency (ESA) to promote mobile satellite communication in Europe, in particular voice capability. The first phase of the MSBN system implementation plan is an experimental phase. Its purpose is to evaluate through field experiments the performance of the MSBN system prior to finalization of its specifications. Particularly, the objective is to verify in the field and possibly improve the performance of the novel satellite access technique BLQS-CDMA (Band Limited Quasi-Synchronous-Code Division Multiple Access), which is proposed as baseline for the MSBN.

The effects of Internet or interactive computer-based patient education in the field of breast cancer: a systematic literature review.

PubMed

Ryhänen, Anne M; Siekkinen, Mervi; Rankinen, Sirkku; Korvenranta, Heikki; Leino-Kilpi, Helena

2010-04-01

The aim of this systematic review was to analyze what kind of Internet or interactive computer-based patient education programs have been developed and to analyze the effectiveness of these programs in the field of breast cancer patient education. Patient education for breast cancer patients is an important intervention to empower the patient. However, we know very little about the effects and potential of Internet-based patient education in the empowerment of breast cancer patients. Complete databases were searched covering the period from the beginning of each database to November 2008. Studies were included if they concerned patient education for breast cancer patients with Internet or interactive computer programs and were based on randomized controlled, on clinical trials or quasi-experimental studies. We identified 14 articles involving 2374 participants. The design was randomized controlled trial in nine papers, in two papers clinical trial and in three quasi-experimental. Seven of the studies were randomized to experimental and control groups, in two papers participants were grouped by ethnic and racial differences and by mode of Internet use and three studies measured the same group pre- and post-tests after using a computer program. The interventions used were described as interactive computer or multimedia programs and use of the Internet. The methodological solutions of the studies varied. The effects of the studies were diverse except for knowledge-related issues. Internet or interactive computer-based patient education programs in the care of breast cancer patients may have positive effect increasing breast cancer knowledge. The results suggest a positive relationship between the Internet or computer-based patient education program use and the knowledge level of patients with breast cancer but a diverse relationship between patient's participation and other outcome measures. There is need to develop and research more Internet-based patient education. 2009 Elsevier Ireland Ltd. All rights reserved.

A school-based program implemented by community providers previously trained for the prevention of eating and weight-related problems in secondary-school adolescents: the MABIC study protocol

PubMed Central

2013-01-01

Background The prevention of eating disorders and disordered eating are increasingly recognized as public health priorities. Challenges in this field included moving from efficacy to effectiveness and developing an integrated approach to the prevention of a broad spectrum of eating and weight-related problems. A previous efficacy trial indicated that a universal disordered eating prevention program, based on the social cognitive model, media literacy educational approach and cognitive dissonance theory, reduced risk factors for disordered eating, but it is unclear whether this program has effects under more real-world conditions. The main aim of this effectiveness trial protocol is to test whether this program has effects when incorporating an integrated approach to prevention and when previously-trained community providers implement the intervention. Methods/design The research design involved a multi-center non-randomized controlled trial with baseline, post and 1-year follow-up measures. Six schools from the city of Sabadell (close to Barcelona) participated in the intervention group, and eleven schools from four towns neighboring Sabadell participated in the control group. A total of 174 girls and 180 boys in the intervention group, and 484 girls and 490 boys in the control group were registered in class lists prior to baseline. A total of 18 community providers, secondary-school class tutors, nurses from the Catalan Government’s Health and School Program, and health promotion technicians from Sabadell City Council were trained and delivered the program. Shared risk factors of eating and weight-related problems were assessed as main measures. Discussion It will be vital for progress in disordered eating prevention to conduct effectiveness trials, which test whether interventions are effective when delivered by community providers under ecologically valid conditions, as opposed to tightly controlled research trials. The MABIC project will provide new contributions in this transition from efficacy to effectiveness and new data about progress in the integrated approach to prevention. Pending the results, the effectiveness trial meets the effectiveness standards set down by the Society for Prevention Research. This study will provide new evidence to improve and enhance disordered eating prevention programs. Trial registration Current Controlled Trials ISRCTN47682626 PMID:24118981

Implementation fidelity of Multidimensional Family Therapy in an international trial.

PubMed

Rowe, Cynthia; Rigter, Henk; Henderson, Craig; Gantner, Andreas; Mos, Kees; Nielsen, Philip; Phan, Olivier

2013-04-01

Implementation fidelity, a critical aspect of clinical trials research that establishes adequate delivery of the treatment as prescribed in treatment manuals and protocols, is also essential to the successful implementation of effective programs into new practice settings. Although infrequently studied in the drug abuse field, stronger implementation fidelity has been linked to better outcomes in practice but appears to be more difficult to achieve with greater distance from model developers. In the INternational CAnnabis Need for Treatment (INCANT) multi-national randomized clinical trial, investigators tested the effectiveness of Multidimensional Family Therapy (MDFT) in comparison to individual psychotherapy (IP) in Brussels, Berlin, Paris, The Hague, and Geneva with 450 adolescents with a cannabis use disorder and their parents. This study reports on the implementation fidelity of MDFT across these five Western European sites in terms of treatment adherence, dose and program differentiation, and discusses possible implications for international implementation efforts. Copyright © 2013 Elsevier Inc. All rights reserved.

Accuracy of genomic selection in European maize elite breeding populations.

PubMed

Zhao, Yusheng; Gowda, Manje; Liu, Wenxin; Würschum, Tobias; Maurer, Hans P; Longin, Friedrich H; Ranc, Nicolas; Reif, Jochen C

2012-03-01

Genomic selection is a promising breeding strategy for rapid improvement of complex traits. The objective of our study was to investigate the prediction accuracy of genomic breeding values through cross validation. The study was based on experimental data of six segregating populations from a half-diallel mating design with 788 testcross progenies from an elite maize breeding program. The plants were intensively phenotyped in multi-location field trials and fingerprinted with 960 SNP markers. We used random regression best linear unbiased prediction in combination with fivefold cross validation. The prediction accuracy across populations was higher for grain moisture (0.90) than for grain yield (0.58). The accuracy of genomic selection realized for grain yield corresponds to the precision of phenotyping at unreplicated field trials in 3-4 locations. As for maize up to three generations are feasible per year, selection gain per unit time is high and, consequently, genomic selection holds great promise for maize breeding programs.

Structure to utilize interventionists' implementation experiences of a family-based behavioral weight management program to enhance the dissemination of the standardized intervention: The TODAY study.

PubMed

Chadwick, Jennifer Q; Van Buren, Dorothy J; Morales, Elisa; Timpson, Alexandra; Abrams, Ericka L; Syme, Amy; Preske, Jeff; Mireles, Gerardo; Anderson, Barbara; Grover, Nisha; Laffel, Lori

2017-08-01

Background For a 2- to 6-year period, interventionists for the TODAY (Treatment Options for type 2 Diabetes in Adolescents and Youth) randomized clinical trial delivered a family-based, behavioral weight-loss program (the TODAY Lifestyle Program) to 234 youth with type 2 diabetes. Interventionists held at least a bachelor's degree in psychology, social work, education, or health-related field and had experience working with children and families, especially from diverse ethnic and socioeconomic backgrounds. This article describes the administrative and organizational structure of the lifestyle program and how the structure facilitated collaboration among study leadership and lifestyle interventionists on the tailoring of the program to best suit the needs of the trial's diverse patient population. Methods During the pilot phase and throughout the duration of the trial, the interventionists' experiences in delivering the intervention were collected in a variety of ways including membership on study committees, survey responses, session audio recordings, and feedback during in-person trainings. Results The experiences of interventionists conveyed to study leadership through these channels resulted in decisions to tailor the lifestyle intervention's delivery location and ways to supplement the standardized educational materials to better address the needs of a diverse patient population. Conclusion The methods used within the TODAY study to encourage and utilize interventionists' experiences while implementing the lifestyle program may be useful to the design of future multi-site, clinical trials seeking to tailor behavioral interventions in a standardized, and culturally and developmentally sensitive manner.

Relationship between NDVI at early bloom and yield in germplasm evaluation trials

USDA-ARS?s Scientific Manuscript database

The use of high-throughput phenotyping (HTP) equipment is expanding as it offers the potential to increase the efficiency of making selections in cotton (Gossypium hirsutum L.) improvement programs. Measurements often being collected on HTP field equipment include normalized difference vegetative in...

Planning Beyond the Next Trial in Adaptive Experiments: A Dynamic Programming Approach.

PubMed

Kim, Woojae; Pitt, Mark A; Lu, Zhong-Lin; Myung, Jay I

2017-11-01

Experimentation is at the heart of scientific inquiry. In the behavioral and neural sciences, where only a limited number of observations can often be made, it is ideal to design an experiment that leads to the rapid accumulation of information about the phenomenon under study. Adaptive experimentation has the potential to accelerate scientific progress by maximizing inferential gain in such research settings. To date, most adaptive experiments have relied on myopic, one-step-ahead strategies in which the stimulus on each trial is selected to maximize inference on the next trial only. A lingering question in the field has been how much additional benefit would be gained by optimizing beyond the next trial. A range of technical challenges has prevented this important question from being addressed adequately. This study applies dynamic programming (DP), a technique applicable for such full-horizon, "global" optimization, to model-based perceptual threshold estimation, a domain that has been a major beneficiary of adaptive methods. The results provide insight into conditions that will benefit from optimizing beyond the next trial. Implications for the use of adaptive methods in cognitive science are discussed. Copyright © 2016 Cognitive Science Society, Inc.

An Applied-Scientific Approach to Field Assessments - Try It Out - A Field Guide for Practitioners (Une approche scientifique des evaluations de terrain - Essayer le - Un guide de terrain a destination des praticiens)

DTIC Science & Technology

2017-12-01

settings – be it field trials, field experiments, tests or evaluations . This guide is based on experience of the the NATO STO Task Group (HFM-211...practice by the Task Group. Feedback from defence colleges and Training and Evaluation staffs is highly welcomed. ES - 2 STO-TR-HFM-211 Une... evaluation programs have been setup to analyse and demonstrate the added value and effectiveness of new developments such as new operational concepts, new

Methodological Foundations for the Empirical Evaluation of Non-Experimental Methods in Field Settings

ERIC Educational Resources Information Center

Wong, Vivian C.; Steiner, Peter M.

2015-01-01

Across the disciplines of economics, political science, public policy, and now, education, the randomized controlled trial (RCT) is the preferred methodology for establishing causal inference about program impacts. But randomized experiments are not always feasible because of ethical, political, and/or practical considerations, so non-experimental…

Improving Preschoolers' Mathematics Achievement with Tablets: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Schacter, John; Jo, Booil

2017-01-01

With a randomized field experiment of 433 preschoolers, we tested a tablet mathematics program designed to increase young children's mathematics learning. Intervention students played Math Shelf, a comprehensive iPad preschool and year 1 mathematics app, while comparison children received research-based hands-on mathematics instruction delivered…

Extending Opportunity: Telidon Technology in Vocational Education.

ERIC Educational Resources Information Center

Turnbull, Amelia Joy

A Mechanics 12 course was chosen by the Alberta Correspondence School for a field trial of computerized delivery systems of vocational education programs to small rural schools where enrollment is low and the construction of vocational laboratories is economically impractical. The Telidon videotex system, which was initially selected, is composed…

A New Mother-Child Play Activity Program to Decrease Parenting Stress and Improve Child Cognitive Abilities: A Cluster Randomized Controlled Trial

PubMed Central

Tachibana, Yoshiyuki; Fukushima, Ai; Saito, Hitomi; Yoneyama, Satoshi; Ushida, Kazuo; Yoneyama, Susumu; Kawashima, Ryuta

2012-01-01

Background We propose a new play activity intervention program for mothers and children. Our interdisciplinary program integrates four fields of child-related sciences: neuroscience, preschool pedagogy, developmental psychology, and child and maternal psychiatry. To determine the effect of this intervention on child and mother psychosocial problems related to parenting stress and on the children's cognitive abilities, we performed a cluster randomized controlled trial. Methodology/Principal Findings Participants were 238 pairs of mothers and typically developing preschool children (ages 4–6 years old) from Wakakusa kindergarten in Japan. The pairs were asked to play at home for about 10 min a day, 5 days a week for 3 months. Participants were randomly assigned to the intervention or control group by class unit. The Parenting Stress Index (PSI) (for mothers), the Goodenough Draw-a-Man intelligence test (DAM), and the new S-S intelligence test (NS-SIT) (for children) were administered prior to and 3 months after the intervention period. Pre–post changes in test scores were compared between the groups using a linear mixed-effects model analysis. The primary outcomes were the Total score on the child domain of the PSI (for child psychosocial problems related to parenting stress), Total score on the parent domain of the PSI (for maternal psychosocial problems related to parenting stress), and the score on the DAM (for child cognitive abilities). The results of the PSI suggested that the program may reduce parenting stress. The results of the cognitive tests suggested that the program may improve the children's fluid intelligence, working memory, and processing speed. Conclusions/Significance Our intervention program may ameliorate the children's psychosocial problems related to parenting stress and increase their cognitive abilities. Trial Registration UMIN Clinical Trials Registry UMIN000002265 PMID:22848340

Genetic progress in oat associated with fungicide use in Rio Grande do Sul, Brazil.

PubMed

Follmann, D N; Cargnelutti Filho, A; Lúcio, A D; de Souza, V Q; Caraffa, M; Wartha, C A

2016-12-19

The State of Rio Grande do Sul (RS) is the largest producer of oat in Brazil with the aid of consolidated breeding programs, which are constantly releasing new cultivars. The main objectives of this study were to: 1) evaluate the annual genetic progress in grain yield and hectoliter weight of the oat cultivars in RS, with and without fungicide use on aerial parts of plants; and 2) evaluate the efficiency of oat breeding programs in introducing disease-resistant genes in the released cultivars through network yield trials conducted with and without fungicide use on aerial plant parts. The data on grain yield and hectoliter weight were obtained from 89 competition field trials of oat cultivars carried out from 2007 to 2014 in nine municipalities of RS. Of the total 89 trials, 44 were carried out with fungicide application on aerial plant parts and 45 were carried out without fungicide application. The annual genetic progress in oat cultivars was studied using the methodology proposed by Vencovsky (1988). The annual genetic progress in oat grain yield was 1.02% with fungicide use and 4.02% without fungicide use during the eight-year study period in RS. The annual genetic progress with respect to the hectoliter weight was 0.08% for trials with fungicide use and 0.71% for trials without fungicide use. Performing network yield trials with and without fungicide use on the aerial plants parts is a feasible method to evaluate the efficiency of oat breeding programs in introducing disease-resistant genes in the released cultivars.

Use of an Atrial Lead with Very Short Tip-To-Ring Spacing Avoids Oversensing of Far-Field R-Wave

PubMed Central

Kolb, Christof; Nölker, Georg; Lennerz, Carsten; Jetter, Hansmartin; Semmler, Verena; Pürner, Klaus; Gutleben, Klaus-Jürgen; Reents, Tilko; Lang, Klaus; Lotze, Ulrich

2012-01-01

Objective The AVOID-FFS (Avoidance of Far-Field R-wave Sensing) study aimed to investigate whether an atrial lead with a very short tip-to-ring spacing without optimization of pacemaker settings shows equally low incidence of far-field R-wave sensing (FFS) when compared to a conventional atrial lead in combination with optimization of the programming. Methods Patients receiving a dual chamber pacemaker were randomly assigned to receive an atrial lead with a tip-to-ring spacing of 1.1 mm or a lead with a conventional tip-to-ring spacing of 10 mm. Postventricular atrial blanking (PVAB) was programmed to the shortest possible value of 60 ms in the study group, and to an individually determined optimized value in the control group. Atrial sensing threshold was programmed to 0.3 mV in both groups. False positive mode switch caused by FFS was evaluated at one and three months post implantation. Results A total of 204 patients (121 male; age 73±10 years) were included in the study. False positive mode switch caused by FFS was detected in one (1%) patient of the study group and two (2%) patients of the control group (p = 0.62). Conclusion The use of an atrial electrode with a very short tip-to-ring spacing avoids inappropriate mode switch caused by FFS without the need for individual PVAB optimization. Trial Registration ClinicalTrials.gov NCT00512915 PMID:22745661

Analyzing Empirical Evaluations of Non-Experimental Methods in Field Settings

ERIC Educational Resources Information Center

Steiner, Peter M.; Wong, Vivian

2016-01-01

Despite recent emphasis on the use of randomized control trials (RCTs) for evaluating education interventions, in most areas of education research, observational methods remain the dominant approach for assessing program effects. Over the last three decades, the within-study comparison (WSC) design has emerged as a method for evaluating the…

A Randomized Trial of a Science, Technology, Engineering, and Mathematics Mentoring Program

ERIC Educational Resources Information Center

Sowers, Jo-Ann; Powers, Laurie; Schmidt, Jessica; Keller, Thomas E.; Turner, Alison; Salazar, Amy; Swank, Paul R.

2017-01-01

Individuals with disabilities are underrepresented in science, technology, engineering, and math (STEM) fields. The purpose of this study was to experimentally evaluate the impact of a STEM mentor intervention and differences between students matched with mentors with or without disabilities on career planning outcomes. An independent groups ×…

System architecture for the Canadian interim mobile satellite system

NASA Technical Reports Server (NTRS)

Shariatmadar, M.; Gordon, K.; Skerry, B.; Eldamhougy, H.; Bossler, D.

1988-01-01

The system architecture for the Canadian Interim Mobile Satellite Service (IMSS) which is planned for commencement of commercial service in late 1989 is reviewed. The results of an associated field trial program which was carried out to determine the limits of coverage and the preliminary performance characteristics of the system are discussed.

Two Brief Interventions to Mitigate a "Chilly Climate" Transform Women's Experience, Relationships, and Achievement in Engineering

ERIC Educational Resources Information Center

Walton, Gregory M.; Logel, Christine; Peach, Jennifer M.; Spencer, Steven J.; Zanna, Mark P.

2015-01-01

In a randomized-controlled trial, we tested 2 brief interventions designed to mitigate the effects of a "chilly climate" women may experience in engineering, especially in male-dominated fields. Participants were students entering a selective university engineering program. The "social-belonging intervention" aimed to protect…

Coping Power Dissemination Study: Intervention and Special Education Effects on Academic Outcomes

ERIC Educational Resources Information Center

Lochman, John E.; Boxmeyer, Caroline L.; Powell, Nicole P.; Qu, Lixin; Wells, Karen; Windle, Michael

2012-01-01

This study examines whether a school-based preventive intervention for children with aggressive behavior affects children's academic outcomes when it is implemented by school counselors in a dissemination field trial. The Coping Power program targets empirical risk factors for aggressive behavior and focuses primarily on teaching social and…

A gloomy picture: a meta-analysis of randomized controlled trials reveals disappointing effectiveness of programs aiming at preventing child maltreatment.

PubMed

Euser, Saskia; Alink, Lenneke Ra; Stoltenborgh, Marije; Bakermans-Kranenburg, Marian J; van IJzendoorn, Marinus H

2015-10-18

Consistent findings about the effectiveness of parent programs to prevent or reduce child maltreatment are lacking. In the present meta-analysis we synthesized findings from 27 independent samples from randomized controlled trials (RCTs) on the effectiveness of 20 different intervention programs aimed at (i) preventing the occurrence of child maltreatment in the general population or with at-risk but non-maltreating families, or (ii) reducing the incidence of child maltreatment in maltreating families. A significant combined effect on maltreatment (d = 0.13; N = 4883) disappeared after the trim-and-fill approach that takes into account publication bias against smaller studies without significant outcomes. However, moderator analyses showed that larger effect sizes were found for more recent studies, studies with smaller samples, programs that provide parent training instead of only support, programs that target maltreating instead of at-risk families, and programs with a moderate length (6-12 months) or a moderate number of sessions (16-30). More RCTs are needed to further unravel which factors are associated with program effectiveness. Because currently existing programs appeared to only reduce and not prevent child maltreatment, efforts in the field of preventive intervention should also focus on the development and testing of preventive programs for families at risk for child maltreatment.

A Health Belief Model-Social Learning Theory approach to adolescents' fertility control: findings from a controlled field trial.

PubMed

Eisen, M; Zellman, G L; McAlister, A L

1992-01-01

We evaluated an 8- to 12-hour Health Belief Model-Social Learning Theory (HBM-SLT)-based sex education program against several community- and school-based interventions in a controlled field experiment. Data on sexual and contraceptive behavior were collected from 1,444 adolescents unselected for gender, race/ethnicity, or virginity status in a pretest-posttest design. Over 60% completed the one-year follow-up. Multivariate analyses were conducted separately for each preintervention virginity status by gender grouping. The results revealed differential program impacts. First, for preintervention virgins, there were no gender or intervention differences in abstinence maintenance over the follow-up year. Second, female preintervention Comparison program virgins used effective contraceptive methods more consistently than those who attended the HBM-SLT program (p less than 0.01); among males, the intervention programs were equally effective. Third, both interventions significantly increased contraceptive efficiency for teenagers who were sexually active before attending the programs. For males, the HBM-SLT program led to significantly greater follow-up contraceptive efficiency than the Comparison program with preintervention contraceptive efficiency controlled (p less than 0.05); for females, the programs produced equivalent improvement. Implications for program planning and evaluation are discussed.

An eHealth program versus a standard care supervised health program and associated health outcomes in individuals with mobility disability: study protocol for a randomized controlled trial.

PubMed

Berglind, Daniel; Nyberg, Gisela; Willmer, Mikaela; Persson, Margareta; Wells, Michael; Forsell, Yvonne

2018-04-27

Young adults with mobility disability (MD) are less likely to engage in regular physical activity (PA) compared with their able-bodied peers and inactive adults with a MD are more likely to report one or more chronic diseases compared to those who are physically active. Despite the vast amount of research published in the field of PA interventions over the past decades, little attention has been focused on interventions aiming to increase PA among individuals with MD. Thus, we propose to compare the effects of an eHealth program compared to a usual care supervised health program on levels of PA and other health behaviors. The current intervention will use a randomized controlled trial (RCT) design with two treatment groups (an eHealth program and a usual care supervised health program) in young adults with newly acquired MD. In total, 110 young adults (aged 18-40 years) with a MD, acquired within the past 3 years, will be recruited to participate in a 12-week intervention. The primary study outcome is accelerometer-measured time spent in moderate to vigorous PA. Secondary outcomes includes health-related quality of life, depression, stress, fitness, body composition, diet, musculoskeletal pain, motivation to exercise and work ability. There is a lack of RCTs investigating effective ways to increase levels of PA in young adults with MD. Increased levels of PA among this physically inactive population have the potential to substantially improve health-related outcomes, possibly more so than in the general population. The trial will put strong emphasis on optimizing exercise adherence and investigating feasibility in the two treatment programs. The Ethical Review Board (EPN) at Karolinska Institutet has approved the study (2017/1206-31/1). International Standard Randomised Controlled Trial Number (ISRCTN), reference number ISRCTN22387524 . Prospectively registered February 4, 2018.

Engineering support activities for the Apollo 17 Surface Electrical Properties Experiment.

NASA Technical Reports Server (NTRS)

Cubley, H. D.

1972-01-01

Description of the engineering support activities which were required to ensure fulfillment of objectives specified for the Apollo 17 SEP (Surface Electrical Properties) Experiment. Attention is given to procedural steps involving verification of hardware acceptability to the astronauts, computer simulation of the experiment hardware, field trials, receiver antenna pattern measurements, and the qualification test program.

Nine year survival of 16 Phytophthora lateralis resistant and susceptible Port-Orford-Cedar families in a Southern Oregon field trial

Treesearch

Richard A. Sniezko; Jim Hamlin; Everett M. Hansen; Sunny Lucas

2012-01-01

Port-Orford-cedar (Chamaecyparis lawsoniana) has suffered high mortality from the pathogen Phytophthora lateralis in portions of its natural range in southwest Oregon and northwest California, as well as in horticultural plantings in North America, and more recently in Europe. A program to develop genetically resistant...

Incidence and severity of cavity spot of carrot as affected by pigmentation, temperature, and rainfall

USDA-ARS?s Scientific Manuscript database

Field trials to determine the effect of carrot pigmentation and weather parameters on cavity spot of carrot (CS) were conducted in the Holland/Bradford Marsh region of Ontario between 2002 and 2009. Twenty three colored carrots from the USDA-ARS breeding program at the University of Wisconsin (5) an...

Viability Study for an Unattended UF 6 Cylinder Verification Station: Phase I Final Report

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

Smith, Leon E.; Miller, Karen A.; Garner, James R.

In recent years, the International Atomic Energy Agency (IAEA) has pursued innovative techniques and an integrated suite of safeguards measures to address the verification challenges posed by the front end of the nuclear fuel cycle. Among the unattended instruments currently being explored by the IAEA is an Unattended Cylinder Verification Station (UCVS) that could provide automated, independent verification of the declared relative enrichment, 235U mass, total uranium mass and identification for all declared UF 6 cylinders in a facility (e.g., uranium enrichment plants and fuel fabrication plants). Under the auspices of the United States and European Commission Support Programs tomore » the IAEA, a project was undertaken to assess the technical and practical viability of the UCVS concept. The US Support Program team consisted of Pacific Northwest National Laboratory (PNNL, lead), Los Alamos National Laboratory (LANL), Oak Ridge National Laboratory (ORNL) and Savanah River National Laboratory (SRNL). At the core of the viability study is a long-term field trial of a prototype UCVS system at a Westinghouse fuel fabrication facility. A key outcome of the study is a quantitative performance evaluation of two nondestructive assay (NDA) methods being considered for inclusion in a UCVS: Hybrid Enrichment Verification Array (HEVA), and Passive Neutron Enrichment Meter (PNEM). This report provides context for the UCVS concept and the field trial: potential UCVS implementation concepts at an enrichment facility; an overview of UCVS prototype design; field trial objectives and activities. Field trial results and interpretation are presented, with a focus on the performance of PNEM and HEVA for the assay of over 200 “typical” Type 30B cylinders, and the viability of an “NDA Fingerprint” concept as a high-fidelity means to periodically verify that the contents of a given cylinder are consistent with previous scans. A modeling study, combined with field-measured instrument uncertainties, provides an assessment of the partial-defect sensitivity of HEVA and PNEM for both one-time assay and (repeated) NDA Fingerprint verification scenarios. The findings presented in this report represent a significant step forward in the community’s understanding of the strengths and limitations of the PNEM and HEVA NDA methods, and the viability of the UCVS concept in front-end fuel cycle facilities. This experience will inform Phase II of the UCVS viability study, should the IAEA pursue it.« less

Research and development of transgenic plants in Malaysia: an example from an Asian developing country.

PubMed

Hashim, Marzukhi; Osman, Mohamad; Abdullah, Ruslan; Pillai, Vilasini; Abu Bakar, Umi K; Hashim, Habibuddin; Daud, Hassan Mat

2002-12-01

In 2000, agriculture contributed 13% to the national gross domestic product of Malaysia. The country of 23 million people has created a competitive program coordinated by the Ministry of Science, Technology and the Environment, research institutions, and universities to undertake biotechnology research in several areas. Intensified research efforts are under way on oil palm, rubber, rice, papaya, and orchids. Although the most progress has been made in rice and papaya, no transgenic crop is ready for field trials. Nonetheless, preliminary steps have been taken to prepare for the trials, and detailed testing protocols are being developed.

Routine programs of health care systems as an opportunity toward communication skills training for family physicians: A randomized field trial

PubMed Central

Zamani, Ahmad Reza; Motamedi, Narges; Farajzadegan, Ziba

2015-01-01

Background: To have high-quality primary health care services, an adequate doctor–patient communication is necessary. Because of time restrictions and limited budget in health system, an effective, feasible, and continuous training approach is important. The aim of this study is to assess the appropriateness of a communication skills training program simultaneously with routine programs of health care system. Materials and Methods: It was a randomized field trial in two health network settings during 2013. Twenty-eight family physicians through simple random sampling and 140 patients through convenience sampling participated as intervention and control group. The physicians in the intervention group (n = 14) attended six educational sessions, simultaneous organization meeting, with case discussion and peer education method. In both the groups, physicians completed communication skills knowledge and attitude questionnaires, and patients completed patient satisfaction of medical interview questionnaire at baseline, immediately after intervention, and four months postintervention. Physicians and health network administrators (stakeholders), completed a set of program evaluation forms. Descriptive statistics and Chi-square test, t-test, and repeated measure analysis of variance were used to analyze the data. Results: Use of routine program as a strategy of training was rated by stakeholders highly on “feasibility” (80.5%), “acceptability” (93.5%), “educational content and method appropriateness” (80.75%), and “ability to integrating in the health system programs” (approximate 60%). Significant improvements were found in physicians’ knowledge (P < 0.001), attitude (P < 0.001), and patients’ satisfaction (P = 0.002) in intervention group. Conclusions: Communication skills training program, simultaneous organization meeting was successfully implemented and well received by stakeholders, without considering extra time and manpower. Therefore it can be a valuable opportunity toward communication skills training. PMID:27462613

Performance evaluation of ALCAN-AASF50-ferric coated activated alumina and granular ferric hydroxide (GFH) for arsenic removal in the presence of competitive ions in an active well :Kirtland field trial - initial studies.

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

Neidel, Linnah L.; Krumhansl, James Lee; Siegel, Malcolm Dean

This report documents a field trial program carried out at Well No.15 located at Kirtland Air Force Base, Albuquerque, New Mexico, to evaluate the performance of two relatively new arsenic removal media, ALCAN-AASF50 (ferric coated activated alumina) and granular ferric hydroxide (US Filter-GFH). The field trial program showed that both media were able to remove arsenate and meet the new total arsenic maximum contaminant level (MCL) in drinking water of 10 {micro}g/L. The arsenate removal capacity was defined at a breakthrough effluent concentration of 5 {micro}g/L arsenic (50% of the arsenic MCL of 10 {micro}g/L). At an influent pH ofmore » 8.1 {+-} 0.4, the arsenate removal capacity of AASF50 was 33.5 mg As(V)/L of dry media (29.9 {micro}g As(V)/g of media on a dry basis). At an influent pH of 7.2 {+-} 0.3, the arsenate removal capacity of GFH was 155 mg As(V)/L of wet media (286 {micro}g As(V)/g of media on a dry basis). Silicate, fluoride, and bicarbonate ions are removed by ALCAN AASF50. Chloride, nitrate, and sulfate ions were not removed by AASF50. The GFH media also removed silicate and bicarbonate ions; however, it did not remove fluoride, chloride, nitrate, and sulfate ions. Differences in the media performance partly reflect the variations in the feed-water pH between the 2 tests. Both the exhausted AASF50 and GFH media passed the Toxicity Characteristic Leaching Procedure (TCLP) test with respect to arsenic and therefore could be disposed as nonhazardous waste.« less

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

Wolff, D.

In agricultural crop improvement, yield under various stress conditions and limiting factors is assessed experimentally. Of the stresses on plants which affect yield are those due to insects. Ostrinia nubilalis, the European corn borer (corn borer) is a major pest in sweet and field corn in the U.S. There are many ways to fight crop pests such as the corn borer, including (1) application of chemical insecticides, (2) application of natural predators and, (3) improving crop resistance through plant genetics programs. Randomized field trials are used to determine the effectiveness of pest management programs. These trials frequently consist of randomlymore » selected crop plots to which well-defined input regimes are instituted. For example, corn borers might be released onto crop plots in several densities at various stages of crop development, then sprayed with different levels of pesticide. These experiments are duplicated across regions and, in some cases across the country, to determine, in this instance for example, the best pesticide application rate for a given pest density and crop development stage. In order to release these pests onto crop plots, one must have an adequate supply of the insect pest. In winter months studies are carried out in the laboratory to examine chemical and natural pesticide effectiveness, as well as such things as the role of pheromones in moth behavior. The advantage in field trials is that yield data can be garnered directly. In this country, insects are raised for crop research primarily through the US Department of Agriculture, in cooperation with public Land Grant Universities and, by the private sector agricultural concerns - seed companies and others. This study quantifies the airborne allergen exposure of persons working in a Land Grant University entomology lab were allergy to European corn borer was suspected.« less

Unit cost analysis of training and deploying paid community health workers in three rural districts of Tanzania.

PubMed

Tani, Kassimu; Exavery, Amon; Baynes, Colin D; Pemba, Senga; Hingora, Ahmed; Manzi, Fatuma; Phillips, James F; Kanté, Almamy Malick

2016-07-08

Tanzania, like other African countries, faces significant health workforce shortages. With advisory and partnership from Columbia University, the Ifakara Health Institute and the Tanzanian Training Centre for International Health (TTCIH) developed and implemented the Connect Project as a randomized cluster experimental trial of the childhood survival impact of recruiting, training, and deploying of a new cadre of paid community health workers (CHW), named "Wawazesha wa afya ya Jamii" (WAJA). This paper presents an estimation of the cost of training and deploying WAJA in three rural districts of Tanzania. Costing data were collected by tracking project activity expenditure records and conducting in-depth interviews of TTCIH staff who have led the training and deployment of WAJA, as well as their counterparts at Public Clinical Training Centres who have responsibility for scaling up the WAJA training program. The trial is registered with the International Standard Randomized Controlled Trial Register number ( ISRCTN96819844 ). The Connect training cost was US$ 2,489.3 per WAJA, of which 40.1 % was for meals, 20.2 % for accommodation 10.2 % for tuition fees and the remaining 29.5 % for other costs including instruction and training facilities and field allowance. A comparable training program estimated unit cost for scaling-up this training via regional/district clinical training centres would be US$ 833.5 per WAJA. Of this unit cost, 50.3 % would involve the cost of meals, 27.4 % training fees, 13.7 % for field allowances, 9 % for accommodation and medical insurance. The annual running cost of WAJA in a village will cost US$ 1.16 per capita. Costs estimated by this study are likely to be sustainable on a large scale, particularly if existing regional/district institutions are utilized for this program.

The Sydney playground project--levelling the playing field: a cluster trial of a primary school-based intervention aiming to promote manageable risk-taking in children with disability.

PubMed

Bundy, Anita C; Wyver, Shirley; Beetham, Kassia S; Ragen, Jo; Naughton, Geraldine; Tranter, Paul; Norman, Richard; Villeneuve, Michelle; Spencer, Grace; Honey, Anne; Simpson, Judith; Baur, Louise; Sterman, Julia

2015-11-14

Providing children and adults with opportunities to engage in manageable risk taking may be a stepping stone toward closing the gap in life conditions currently experienced by young people with disabilities. We aim to demonstrate the effectiveness of a simple, innovative program for 1) changing the way parents and teachers view manageable risk-taking for children with disabilities and 2) increasing the level of responsibility that children take for their own actions, as seen on the school playground. We will employ a cluster repeated measures trial with six Sydney-area primary-school-based programs for children with disabilities. The intervention comprises two arms. 1) Risk-reframing--teachers and parents will participate together in small group intervention sessions focusing on the benefits of manageable risk-taking; 2) Introduction of play materials--materials without a defined purpose and facilitative of social cooperation will be introduced to the school playground for children to use at all break times. A control period will be undertaken first for two school terms, followed by two terms of the intervention period. Outcome measures will include playground observations, The Coping Inventory, qualitative field notes, and The Tolerance of Risk in Play Scale. New national programs, such as Australia's National Disability Insurance Scheme, will place increasing demands on young people with disabilities to assume responsibility for difficult decisions regarding procuring services. Innovative approaches, commencing early in life, are required to prepare young people and their carers for this level of responsibility. This research offers innovative intervention strategies for promoting autonomy in children with disabilities and their carers. Australian and New Zealand Clinical Trials Registration Number ACTRN12614000549628 (registered 22/5/2014).

Moving from rhetoric to reality: adapting Housing First for homeless individuals with mental illness from ethno-racial groups

PubMed Central

2012-01-01

Background The literature on interventions addressing the intersection of homelessness, mental illness and race is scant. The At Home/Chez Soi research demonstration project is a pragmatic field trial investigating a Housing First intervention for homeless individuals with mental illness in five cities across Canada. A unique focus at the Toronto site has been the development and implementation of a Housing First Ethno-Racial Intensive Case Management (HF ER-ICM) arm of the trial serving 100 homeless individuals with mental illness from ethno-racial groups. The HF ER-ICM program combines the Housing First approach with an anti-racism/anti-oppression framework of practice. This paper presents the findings of an early implementation and fidelity evaluation of the HF ER-ICM program, supplemented by participant narrative interviews to inform our understanding of the HF ER-ICM program theory. Methods Descriptive statistics are used to describe HF ER-ICM participant characteristics. Focus group interviews, key informant interviews and fidelity assessments were conducted between November 2010 and January 2011, as part of the program implementation evaluation. In-depth qualitative interviews with HF ER-ICM participants and control group members were conducted between March 2010 and June 2011. All qualitative data were analysed using grounded theory methodology. Results The target population had complex health and social service needs. The HF ER-ICM program enjoyed a high degree of fidelity to principles of both anti-racism/anti-oppression practice and Housing First and comprehensively addressed the housing, health and sociocultural needs of participants. Program providers reported congruence of these philosophies of practice, and program participants valued the program and its components. Conclusions Adapting Housing First with anti-racism/anti-oppression principles offers a promising approach to serving the diverse needs of homeless people from ethno-racial groups and strengthening the service systems developed to support them. The use of fidelity and implementation evaluations can be helpful in supporting successful adaptations of programs and services. Trial registration Current Controlled Trials ISRCTN42520374 PMID:23031406

Robotic assistants in personal care: A scoping review.

PubMed

Bilyea, A; Seth, N; Nesathurai, S; Abdullah, H A

2017-11-01

The aim of this study is to present an overview of the technological advances in the field of robotics developed for assistance with activities of daily living (ADL), and to present areas where further research is required. Four databases were searched for articles presenting either a novel design of one of these personal care robotic system or trial results relating to these systems. Articles presenting nine different robotic personal care systems were examined, six of which had been developed after 2005. These six also all have publications relating to their trials. In the majority of trials, patient independence was improved with operation of the robotic device for a specific subset of ADL. A map of the current state of the field of personal care robotics is presented in this study. Areas requiring further research include improving feedback and awareness, as well as refining control methods and pre-programmed behaviors. Developing an affordable, easy to use system would help fill the current gap in the commercial market. Copyright © 2017 IPEM. Published by Elsevier Ltd. All rights reserved.

An Intervention to Optimize Coach Motivational Climates and Reduce Athlete Willingness to Dope (CoachMADE): Protocol for a Cross-Cultural Cluster Randomized Control Trial

PubMed Central

Ntoumanis, Nikos; Gucciardi, Daniel F.; Backhouse, Susan H.; Barkoukis, Vassilis; Quested, Eleanor; Patterson, Laurie; Smith, Brendan J.; Whitaker, Lisa; Pavlidis, George; Kaffe, Stela

2018-01-01

Field-based anti-doping interventions in sport are scarce and focus on athletes. However, coaches are recognized as one of the most significant source of influence in terms of athletes’ cognitions, affect, and behavior. In this paper, we present the protocol for a cluster randomized control trial which aims to contrast the relative effects of a ‘motivation and anti-doping’ intervention program for coaches against an information-based anti-doping control program. In developing the motivation content of our intervention, we drew from Self-Determination Theory. The project is currently ongoing in Australia and has recently started in the United Kingdom and Greece. We aim to recruit 120 coaches and approximately 1200 of their athletes across the three countries. Various assessments will be taken from both coaches and athletes prior to the intervention, immediately after the 12-week intervention and at a 2-month follow up. The intervention comprises face-to-face workshops and weekly activities which are supported by printed and online material. The project aims to identify communication strategies that coaches can use to support athletes’ motivation in sport and also to promote self-determined reasons for athletes to comply with doping regulations. Trial Registration: The trial is registered with the Australia and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12616001688471. PMID:29375428

An Intervention to Optimize Coach Motivational Climates and Reduce Athlete Willingness to Dope (CoachMADE): Protocol for a Cross-Cultural Cluster Randomized Control Trial.

PubMed

Ntoumanis, Nikos; Gucciardi, Daniel F; Backhouse, Susan H; Barkoukis, Vassilis; Quested, Eleanor; Patterson, Laurie; Smith, Brendan J; Whitaker, Lisa; Pavlidis, George; Kaffe, Stela

2017-01-01

Field-based anti-doping interventions in sport are scarce and focus on athletes. However, coaches are recognized as one of the most significant source of influence in terms of athletes' cognitions, affect, and behavior. In this paper, we present the protocol for a cluster randomized control trial which aims to contrast the relative effects of a 'motivation and anti-doping' intervention program for coaches against an information-based anti-doping control program. In developing the motivation content of our intervention, we drew from Self-Determination Theory. The project is currently ongoing in Australia and has recently started in the United Kingdom and Greece. We aim to recruit 120 coaches and approximately 1200 of their athletes across the three countries. Various assessments will be taken from both coaches and athletes prior to the intervention, immediately after the 12-week intervention and at a 2-month follow up. The intervention comprises face-to-face workshops and weekly activities which are supported by printed and online material. The project aims to identify communication strategies that coaches can use to support athletes' motivation in sport and also to promote self-determined reasons for athletes to comply with doping regulations. Trial Registration: The trial is registered with the Australia and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12616001688471.

The role of economics in the QUERI program: QUERI Series

PubMed Central

Smith, Mark W; Barnett, Paul G

2008-01-01

Background The United States (U.S.) Department of Veterans Affairs (VA) Quality Enhancement Research Initiative (QUERI) has implemented economic analyses in single-site and multi-site clinical trials. To date, no one has reviewed whether the QUERI Centers are taking an optimal approach to doing so. Consistent with the continuous learning culture of the QUERI Program, this paper provides such a reflection. Methods We present a case study of QUERI as an example of how economic considerations can and should be integrated into implementation research within both single and multi-site studies. We review theoretical and applied cost research in implementation studies outside and within VA. We also present a critique of the use of economic research within the QUERI program. Results Economic evaluation is a key element of implementation research. QUERI has contributed many developments in the field of implementation but has only recently begun multi-site implementation trials across multiple regions within the national VA healthcare system. These trials are unusual in their emphasis on developing detailed costs of implementation, as well as in the use of business case analyses (budget impact analyses). Conclusion Economics appears to play an important role in QUERI implementation studies, only after implementation has reached the stage of multi-site trials. Economic analysis could better inform the choice of which clinical best practices to implement and the choice of implementation interventions to employ. QUERI economics also would benefit from research on costing methods and development of widely accepted international standards for implementation economics. PMID:18430199

The role of economics in the QUERI program: QUERI Series.

PubMed

Smith, Mark W; Barnett, Paul G

2008-04-22

The United States (U.S.) Department of Veterans Affairs (VA) Quality Enhancement Research Initiative (QUERI) has implemented economic analyses in single-site and multi-site clinical trials. To date, no one has reviewed whether the QUERI Centers are taking an optimal approach to doing so. Consistent with the continuous learning culture of the QUERI Program, this paper provides such a reflection. We present a case study of QUERI as an example of how economic considerations can and should be integrated into implementation research within both single and multi-site studies. We review theoretical and applied cost research in implementation studies outside and within VA. We also present a critique of the use of economic research within the QUERI program. Economic evaluation is a key element of implementation research. QUERI has contributed many developments in the field of implementation but has only recently begun multi-site implementation trials across multiple regions within the national VA healthcare system. These trials are unusual in their emphasis on developing detailed costs of implementation, as well as in the use of business case analyses (budget impact analyses). Economics appears to play an important role in QUERI implementation studies, only after implementation has reached the stage of multi-site trials. Economic analysis could better inform the choice of which clinical best practices to implement and the choice of implementation interventions to employ. QUERI economics also would benefit from research on costing methods and development of widely accepted international standards for implementation economics.

Educational Technology Program. Quarterly Technical Summary Report, 1 December 1971-29 February 1972.

ERIC Educational Resources Information Center

Frick, Frederick C.

The Lincoln Training System (LTS-3) is a computer-assisted instructional system for training Air Traffic Controllers and Basic Electronic students in the United States Air Force. This document describes the components of the system prior to its initial field trial in mid-April 1972 at Kessler Air Force Base. The system is made up of 14 Basic…

Aquatic Plant Control Research Program. Proceedings, Annual Meeting, Aquatic Plant Control Research Program (23rd) Held in West Palm Beach, Florida on 14-17 November 1988

DTIC Science & Technology

1989-06-01

stage lasted 3 days, and complete development took 23 days in both species. Adult longevity averaged about 18 days, which was about 7 days longer than...hydrilla leaf Australian hydrilla fly in hydrilla destroys fewer leaves. In the field, however, its longer adult longevity might favor it. Together, the...trials. It appears to us that, as well as pioneering a novel ecosystems-compatible approach, the transition from basic research in an academic setting

New quality assurance program integrating "modern radiotherapy" within the German Hodgkin Study Group.

PubMed

Kriz, J; Baues, C; Engenhart-Cabillic, R; Haverkamp, U; Herfarth, K; Lukas, P; Schmidberger, H; Marnitz-Schulze, S; Fuchs, M; Engert, A; Eich, H T

2017-02-01

Field design changed substantially from extended-field RT (EF-RT) to involved-field RT (IF-RT) and now to involved-node RT (IN-RT) and involved-site RT (IS-RT) as well as treatment techniques in radiotherapy (RT) of Hodgkin's lymphoma (HL). The purpose of this article is to demonstrate the establishment of a quality assurance program (QAP) including modern RT techniques and field designs within the German Hodgkin Study Group (GHSG). In the era of modern conformal RT, this QAP had to be fundamentally adapted and a new evaluation process has been intensively discussed by the radiotherapeutic expert panel of the GHSG. The expert panel developed guidelines and criteria to analyse "modern" field designs and treatment techniques. This work is based on a dataset of 11 patients treated within the sixth study generation (HD16-17). To develop a QAP of "modern RT", the expert panel defined criteria for analysing current RT procedures. The consensus of a modified QAP in ongoing and future trials is presented. With this schedule, the QAP of the GHSG could serve as a model for other study groups.

Comparative field trial of alternative vector control strategies for non-domiciliated Triatoma dimidiata.

PubMed

Ferral, Jhibran; Chavez-Nuñez, Leysi; Euan-Garcia, Maria; Ramirez-Sierra, Maria Jesus; Najera-Vazquez, M Rosario; Dumonteil, Eric

2010-01-01

Chagas disease is a major vector-borne disease, and regional initiatives based on insecticide spraying have successfully controlled domiciliated vectors in many regions. Non-domiciliated vectors remain responsible for a significant transmission risk, and their control is a challenge. We performed a proof-of-concept field trial to test alternative strategies in rural Yucatan, Mexico. Follow-up of house infestation for two seasons following the interventions confirmed that insecticide spraying should be performed annually for the effective control of Triatoma dimidiata; however, it also confirmed that insect screens or long-lasting impregnated curtains may represent good alternative strategies for the sustained control of these vectors. Ecosystemic peridomicile management would be an excellent complementary strategy to improve the cost-effectiveness of interventions. Because these strategies would also be effective against other vector-borne diseases, such as malaria or dengue, they could be integrated within a multi-disease control program.

DOE and JAEA Field Trial of the Single Chip Shift Register (SCSR)

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

Newell, Matthew R.

2016-03-23

Los Alamos National Laboratories (LANL) has recently developed a new data acquisition system for multiplicity analysis of neutron detector pulse streams. This new technology, the Single Chip Shift Register (SCSR), places the entire data acquisition system along with the communications hardware onto a single chip. This greatly simplifies the instrument and reduces the size. The SCSR is designed to be mounted into the neutron detector head alongside the instrument amplifiers. The user’s computer connects via USB directly to the neutron detector eliminating the external data acquisition electronics entirely. JAEA, through the INSEP program, asked LANL to demonstrate the functionality ofmore » the SCSR in Tokai using the JAEA Epithermal Neutron Multiplicity Counter, ENMC. In late September of 2015 LANL traveled to Tokai to install, demonstrate and uninstall the SCSR in the ENMC. This report documents the results of that field trial.« less

Behavioral Decision Research Intervention Reduces Risky Sexual Behavior.

PubMed

Downs, Julie S; Bruine de Bruin, Wändi; Fischhoff, Baruch; Murray, Pamela J

2015-01-01

Although adolescents are at disproportionate risk for sexually transmitted infections, most sex education programs have shown little effect on sexual behavior. An interactive video intervention developed by our team has been identified as one of a few programs that have been documented to reduce sexually transmitted infections in this population. Building on behavioral decision research, we used a mental models approach to interview young women about their sexual decisions, finding, among other things, the strong role of perceived social norms. We based our intervention on these results, aiming to help young women identify and implement personally and socially acceptable decision strategies. A randomized controlled trial found that the video reduced risky sexual behavior and the acquisition of chlamydia infection. We recently revised the video to suit more diverse audiences, and upgraded it to modern standards of cinematography and interactivity. It is now in field trial.

Behavioral Decision Research Intervention Reduces Risky Sexual Behavior Accepted for publication in Current HIV Research

PubMed Central

Downs, Julie S.; de Bruin, Wändi Bruine; Fischhoff, Baruch; Murray, Pamela J.

2017-01-01

Although adolescents are at disproportionate risk for sexually transmitted infections, most sex education programs have shown little effect on sexual behavior. An interactive video intervention developed by our team has been identified as one of a few programs that have been documented to reduce sexually transmitted infections in this population. Building on behavioral decision research, we used a mental models approach to interview young women about their sexual decisions, finding, among other things, the strong role of perceived social norms. We based our intervention on these results, aiming to help young women identify and implement personally and socially acceptable decision strategies. A randomized controlled trial found that the video reduced risky sexual behavior and the acquisition of chlamydia infection. We recently revised the video to suit more diverse audiences, and upgraded it to modern standards of cinematography and interactivity. It is now in field trial. PMID:26149165

A new mother-child play activity program to decrease parenting stress and improve child cognitive abilities: a cluster randomized controlled trial.

PubMed

Tachibana, Yoshiyuki; Fukushima, Ai; Saito, Hitomi; Yoneyama, Satoshi; Ushida, Kazuo; Yoneyama, Susumu; Kawashima, Ryuta

2012-01-01

We propose a new play activity intervention program for mothers and children. Our interdisciplinary program integrates four fields of child-related sciences: neuroscience, preschool pedagogy, developmental psychology, and child and maternal psychiatry. To determine the effect of this intervention on child and mother psychosocial problems related to parenting stress and on the children's cognitive abilities, we performed a cluster randomized controlled trial. Participants were 238 pairs of mothers and typically developing preschool children (ages 4-6 years old) from Wakakusa kindergarten in Japan. The pairs were asked to play at home for about 10 min a day, 5 days a week for 3 months. Participants were randomly assigned to the intervention or control group by class unit. The Parenting Stress Index (PSI) (for mothers), the Goodenough Draw-a-Man intelligence test (DAM), and the new S-S intelligence test (NS-SIT) (for children) were administered prior to and 3 months after the intervention period. Pre-post changes in test scores were compared between the groups using a linear mixed-effects model analysis. The primary outcomes were the Total score on the child domain of the PSI (for child psychosocial problems related to parenting stress), Total score on the parent domain of the PSI (for maternal psychosocial problems related to parenting stress), and the score on the DAM (for child cognitive abilities). The results of the PSI suggested that the program may reduce parenting stress. The results of the cognitive tests suggested that the program may improve the children's fluid intelligence, working memory, and processing speed. Our intervention program may ameliorate the children's psychosocial problems related to parenting stress and increase their cognitive abilities. UMIN Clinical Trials Registry UMIN000002265.

Effects of a tele-prehabilitation program or an in-person prehabilitation program in surgical candidates awaiting total hip or knee arthroplasty: Protocol of a pilot single blind randomized controlled trial.

PubMed

Doiron-Cadrin, Patrick; Kairy, Dahlia; Vendittoli, Pascal-André; Lowry, Véronique; Poitras, Stéphane; Desmeules, François

2016-12-15

The accessibility for total joint arthroplasty often comes up against long wait lists, and may lead to deleterious effects for the awaiting patients. This pilot single blind randomized controlled trial aims to evaluate the impact of a telerehabilitation prehabilitation program before a hip or knee arthroplasty compared to in-person prehabilitation or to usual wait for surgery. Thirty-six patients on a wait list for a total hip or knee arthroplasty will be recruited and randomly assigned to one of three groups. The in-person prehabilitation group (n = 12) will receive a 12-week rehabilitation program (2 sessions/week) including education, exercises of the lower limb and cardiovascular training. Patients in the tele-prehabilitation group (n = 12) will receive the same intervention using a telecommunication software. The control group (n = 12) will be provided with the hospital's usual documentation before surgery. The Lower Extremity Functional Scale (LEFS) will be the primary outcome measure taken at baseline and at 12 weeks. Secondary measures will include self-reported function and quality of life as well as performance tests. A mixed-model, 2-way repeated-measure ANOVA will be used to analyse the effects of the rehabilitation programs. This pilot study is the first to evaluate the feasibility and the impact of a telerehabilitation prehabilitation program for patients awaiting a total joint arthroplasty. The results of this pilot-RCT will set the foundations for further research in the fields of rehabilitation and tele-medicine for patients suffering from lower limb osteoarthritis. ClinicalTrials.gov: NCT02636751.

Thinking, Fast and Slow? Some Field Experiments to Reduce Crime and Dropout in Chicago. NBER Working Paper 21178

ERIC Educational Resources Information Center

Heller, Sara B.; Shah, Anuj K.; Guryan, Jonathan; Ludwig, Jens; Mullainathan, Sendhil; Pollack, Harold A.

2015-01-01

We present the results of three large-scale randomized controlled trials (RCTs) carried out in Chicago, testing interventions to reduce crime and dropout by changing the decision-making of economically disadvantaged youth. We study a program called Becoming a Man (BAM), developed by the non-profit Youth Guidance, in two RCTs implemented in 2009-10…

Exploring and reducing stress in young restaurant workers: results of a randomized field trial.

PubMed

Petree, Robyn D; Broome, Kirk M; Bennett, Joel B

2012-01-01

Young adult restaurant workers face the dual stressors of work adjustment and managing personal responsibilities. We assessed a new psychosocial/health promotion training designed to reduce these stressors in the context of restaurant work. DESIGN . A cluster-randomized trial of a training program, with surveys administered approximately 2 weeks before training and both 6 and 12 months after training. A national restaurant chain. A total of 947 restaurant workers in 28 restaurants. Personal stress, exposure to problem coworkers, and personal and job characteristics. Team Resilience (TR) is an interactive program for stress management, teamwork, and work-life balance. TR focuses on "five Cs" of resilience: compassion, commitment, centering, community, and confidence. ANALYSIS . Mixed-model (multilevel) analysis of covariances. Compared with workers in control stores, workers in TR-trained stores showed significant reductions over time in exposure to problem coworkers (F[2, 80.60]  =  4.48; p  =  .01) and in personal stress (F[2, 75.28]  =  6.12; p  =  .003). The TR program may help young workers who face the challenges of emerging adulthood and work-life balance.

Catch trials in force field learning influence adaptation and consolidation of human motor memory

PubMed Central

Stockinger, Christian; Focke, Anne; Stein, Thorsten

2014-01-01

Force field studies are a common tool to investigate motor adaptation and consolidation. Thereby, subjects usually adapt their reaching movements to force field perturbations induced by a robotic device. In this context, so-called catch trials, in which the disturbing forces are randomly turned off, are commonly used to detect after-effects of motor adaptation. However, catch trials also produce sudden large motor errors that might influence the motor adaptation and the consolidation process. Yet, the detailed influence of catch trials is far from clear. Thus, the aim of this study was to investigate the influence of catch trials on motor adaptation and consolidation in force field experiments. Therefore, 105 subjects adapted their reaching movements to robot-generated force fields. The test groups adapted their reaching movements to a force field A followed by learning a second interfering force field B before retest of A (ABA). The control groups were not exposed to force field B (AA). To examine the influence of diverse catch trial ratios, subjects received catch trials during force field adaptation with a probability of either 0, 10, 20, 30, or 40%, depending on the group. First, the results on motor adaptation revealed significant differences between the diverse catch trial ratio groups. With increasing amount of catch trials, the subjects' motor performance decreased and subjects' ability to accurately predict the force field—and therefore internal model formation—was impaired. Second, our results revealed that adapting with catch trials can influence the following consolidation process as indicated by a partial reduction to interference. Here, the optimal catch trial ratio was 30%. However, detection of consolidation seems to be biased by the applied measure of performance. PMID:24795598

The role of treatment fidelity on outcomes during a randomized field trial of an autism intervention

PubMed Central

Mandell, David S; Stahmer, Aubyn C; Shin, Sujie; Xie, Ming; Reisinger, Erica; Marcus, Steven C

2013-01-01

This randomized field trial comparing Strategies for Teaching based on Autism Research and Structured Teaching enrolled educators in 33 kindergarten-through-second-grade autism support classrooms and 119 students, aged 5–8 years in the School District of Philadelphia. Students were assessed at the beginning and end of the academic year using the Differential Ability Scales. Program fidelity was measured through video coding and use of a checklist. Outcomes were assessed using linear regression with random effects for classroom and student. Average fidelity was 57% in Strategies for Teaching based on Autism Research classrooms and 48% in Structured Teaching classrooms. There was a 9.2-point (standard deviation = 9.6) increase in Differential Ability Scales score over the 8-month study period, but no main effect of program. There was a significant interaction between fidelity and group. In classrooms with either low or high program fidelity, students in Strategies for Teaching based on Autism Research experienced a greater gain in Differential Ability Scales score than students in Structured Teaching (11.2 vs 5.5 points and 11.3 vs 8.9 points, respectively). In classrooms with moderate fidelity, students in Structured Teaching experienced a greater gain than students in Strategies for Teaching based on Autism Research (10.1 vs 4.4 points). The results suggest significant variability in implementation of evidence-based practices, even with supports, and also suggest the need to address challenging issues related to implementation measurement in community settings. PMID:23592849

Parkinson's Disease Gene Therapy: Success by Design Meets Failure by Efficacy

PubMed Central

Bartus, Raymond T; Weinberg, Marc S; Samulski, R. Jude

2014-01-01

Over the past decade, nine gene therapy clinical trials for Parkinson's disease (PD) have been initiated and completed. Starting with considerable optimism at the initiation of each trial, none of the programs has yet borne sufficiently robust clinical efficacy or found a clear path toward regulatory approval. Despite the immediately disappointing nature of the efficacy outcomes in these trials, the clinical data garnered from the individual studies nonetheless represent tangible and significant progress for the gene therapy field. Collectively, the clinical trials demonstrate that we have overcome the major safety hurdles previously suppressing central nervous system (CNS) gene therapy, for none produced any evidence of untoward risk or harm after administration of various vector-delivery systems. More importantly, these studies also demonstrated controlled, highly persistent generation of biologically active proteins targeted to structures deep in the human brain. Therefore, a renewed, focused emphasis must be placed on advancing clinical efficacy by improving clinical trial design, patient selection and outcome measures, developing more predictive animal models to support clinical testing, carefully performing retrospective analyses, and most importantly moving forward—beyond our past limits. PMID:24356252

Selection of Cultivars for use in Controlled Environment Life Support System (CELSS) Human Rated Test Facility (HRTF) Trials

NASA Technical Reports Server (NTRS)

Langhans, Robert W.

1997-01-01

The aims under this training grant, as under the subsequent fellowship, were to elaborate the theory and technique of cultivar evaluation for specialized controlled environments, then to employ the technique on selected crops, ultimately conducting cultivar trials, and making the knowledge gained available for use in NASA's space program. We undertook a comprehensive search of the Cornell agricultural library (Mann library) and its data-bases for any and all material relating to cultivar evaluation of vegetable crops, and also developed the logic of how to go about narrowing down the field of contending cultivars when undertaking cultivar trials. The results of this work, the principal outcome of the grant, are reflected in his MS thesis, particularly in Chapter 2, "Commercial and Scientific Literature," and even more so in Chapter 8, "Selecting cultivars and lines for screening." David also attended annual conferences of vegetable crop plant breeders, annual yield trials and breeding trials for vegetable crops, as well as relevant professional conferences such as the ASHS annual meetings, and the others.

Preparing beginning reading teachers: An experimental comparison of initial early literacy field experiences.

PubMed

Al Otaiba, Stephanie; Lake, Vickie E; Greulich, Luana; Folsom, Jessica S; Guidry, Lisa

2012-01-01

This randomized-control trial examined the learning of preservice teachers taking an initial Early Literacy course in an early childhood education program and of the kindergarten or first grade students they tutored in their field experience. Preservice teachers were randomly assigned to one of two tutoring programs: Book Buddies and Tutor Assisted Intensive Learning Strategies (TAILS), which provided identical meaning-focused instruction (shared book reading), but differed in the presentation of code-focused skills. TAILS used explicit, scripted lessons, and the Book Buddies required that code-focused instruction take place during shared book reading. Our research goal was to understand which tutoring program would be most effective in improving knowledge about reading, lead to broad and deep language and preparedness of the novice preservice teachers, and yield the most successful student reading outcomes. Findings indicate that all pre-service teachers demonstrated similar gains in knowledge, but preservice teachers in the TAILS program demonstrated broader and deeper application of knowledge and higher self-ratings of preparedness to teach reading. Students in both conditions made similar comprehension gains, but students tutored with TAILS showed significantly stronger decoding gains.

Outcomes of a School-Based Intervention (RESCATE) to Improve Physical Activity Patterns in Mexican Children Aged 8-10 Years

ERIC Educational Resources Information Center

Colin-Ramirez, E.; Castillo-Martinez, L.; Orea-Tejeda, A.; Vergara-Castaneda, A.; Keirns-Davis, C.; Villa-Romero, A.

2010-01-01

The aim of this study was to evaluate the impact of an intervention program on the patterns of physical activity in 8- to 10-year-old Mexican children from lower socioeconomic status. This study performed a randomized controlled field trial in 498 children aged 8-10 years from 10 public schools of low socioeconomic status in Mexico City. Schools…

Sequential sampling of ribes populations in the control of white pine blister rust (Cronartium ribicola Fischer) in California

Treesearch

Harold R. Offord

1966-01-01

Sequential sampling based on a negative binomial distribution of ribes populations required less than half the time taken by regular systematic line transect sampling in a comparison test. It gave the same control decision as the regular method in 9 of 13 field trials. A computer program that permits sequential plans to be built readily for other white pine regions is...

75 FR 4827 - Submission for OMB Review; Comment Request Clinical Trials Reporting Program (CTRP) Database (NCI)

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-29

...; Comment Request Clinical Trials Reporting Program (CTRP) Database (NCI) Summary: Under the provisions of... Collection: Title: Clinical Trials Reporting Program (CTRP) Database. Type of Information Collection Request... Program (CTRP) Database, to serve as a single, definitive source of information about all NCI-supported...

A home-based exercise program for children with congenital heart disease following interventional cardiac catheterization: study protocol for a randomized controlled trial.

PubMed

Du, Qing; Salem, Yasser; Liu, Hao Howe; Zhou, Xuan; Chen, Sun; Chen, Nan; Yang, Xiaoyan; Liang, Juping; Sun, Kun

2017-01-23

Cardiac catheterization has opened an innovative treatment field for cardiac disease; this treatment is becoming the most popular approach for pediatric congenital heart disease (CHD) and has led to a significant growth in the number of children with cardiac catheterization. Unfortunately, based on evidence, it has been demonstrated that the majority of children with CHD are at an increased risk of "non-cardiac" problems. Effective exercise therapy could improve their functional status significantly. As studies identifying the efficacy of exercise therapy are rare in this field, the aims of this study are to (1) identify the efficacy of a home-based exercise program to improve the motor function of children with CHD with cardiac catheterization, (2) reduce parental anxiety and parenting burden, and (3) improve the quality of life for parents whose children are diagnosed with CHD with cardiac catheterization through the program. A total of 300 children who will perform a cardiac catheterization will be randomly assigned to two groups: a home-based intervention group and a control group. The home-based intervention group will carry out a home-based exercise program, and the control group will receive only home-based exercise education. Assessments will be undertaken before catheterization and at 1, 3, and 6 months after catheterization. Motor ability quotients will be assessed as the primary outcomes. The modified Ross score, cardiac function, speed of sound at the tibia, functional independence of the children, anxiety, quality of life, and caregiver burden of their parents or the main caregivers will be the secondary outcome measurements. The proposed prospective randomized controlled trial will evaluate the efficiency of a home-based exercise program for children with CHD with cardiac catheterization. We anticipate that the home-based exercise program may represent a valuable and efficient intervention for children with CHD and their families. http://www.chictr.org.cn/ on: ChiCTR-IOR-16007762 . Registered on 13 January 2016.

SUPERFUND TREATABILITY CLEARINGHOUSE: FULL SCALE ROTARY KILN INCINERATOR FIELD TRIAL: PHASE I, VERIFICATION TRIAL BURN ON DIOXIN/HERBICIDE ORANGE CONTAMINATED SOIL

EPA Science Inventory

This treatability study reports on the results of one of a series of field trials using various remedial action technologies that may be capable of restoring Herbicide Orange (HO)XDioxin contaminated sites. A full-scale field trial using a rotary kiln incinerator capable of pro...

A new combined strategy to implement a community occupational therapy intervention: designing a cluster randomized controlled trial

PubMed Central

2011-01-01

Background Even effective interventions for people with dementia and their caregivers require specific implementation efforts. A pilot study showed that the highly effective community occupational therapy in dementia (COTiD) program was not implemented optimally due to various barriers. To decrease these barriers and make implementation of the program more effective a combined implementation (CI) strategy was developed. In our study we will compare the effectiveness of this CI strategy with the usual educational (ED) strategy. Methods In this cluster randomized, single-blinded, controlled trial, each cluster consists of at least two occupational therapists, a manager, and a physician working at Dutch healthcare organizations that deliver community occupational therapy. Forty-five clusters, stratified by healthcare setting (nursing home, hospital, mental health service), have been allocated randomly to either the intervention group (CI strategy) or the control group (ED strategy). The study population consists of the professionals included in each cluster and community-dwelling people with dementia and their caregivers. The primary outcome measures are the use of community OT, the adherence of OTs to the COTiD program, and the cost effectiveness of implementing the COTiD program in outpatient care. Secondary outcome measures are patient and caregiver outcomes and knowledge of managers, physicians and OTs about the COTiD program. Discussion Implementation research is fairly new in the field of occupational therapy, making this a unique study. This study does not only evaluate the effects of the CI-strategy on professionals, but also the effects of professionals' degree of implementation on client and caregiver outcomes. Clinical trials registration NCT01117285 PMID:21450063

Young driver education programs that build resilience have potential to reduce road crashes.

PubMed

Senserrick, Teresa; Ivers, Rebecca; Boufous, Soufiane; Chen, Huei-Yang; Norton, Robyn; Stevenson, Mark; van Beurden, Eric; Zask, Avigdor

2009-11-01

The research aimed to explore associations between participation in 2 education programs for school-based learner drivers and subsequent road traffic offenses and crashes among a large cohort of newly licensed drivers. DRIVE is a prospective cohort study of 20822 first-year drivers aged 17 to 24 in New South Wales (NSW), Australia. Participants completed a detailed questionnaire and consented to data linkage in 2003-2004. Questionnaire items included year of participation in 2 specific education programs: a 1-day workshop-only program focusing on driving risks ("driver-focused") and a whole-of-community program also including a 1-day workshop but also longer term follow-up activities and a broader focus on reducing risk-taking and building resilience ("resilience-focused"). Survey data were subsequently linked to police-reported crash and offense data for 1996-2005. Poisson regression models that adjusted for multiple confounders were created to explore offenses and crashes as a driver (dichotomized as 0 vs >or=1) after program participation. Offenses did not differ between groups; however, whereas the driver-focused program was not associated with reduced crash risk, the resilience-focused program was associated with a 44% reduced relative risk for crash (0.56 [95% confidence interval: 0.34-0.93]). The large effect size observed and complementary findings from a comparable randomized, controlled trial in the United States suggest programs that focus more generally on reducing risks and building resilience have the potential to reduce crashes. A large, representative, randomized, controlled trial is urgently needed to confirm road safety benefits and ensure evidence-based spending and practitioner recommendations in this field.

Components of effective randomized controlled trials of hydrotherapy programs for fibromyalgia syndrome: A systematic review.

PubMed

Perraton, Luke; Machotka, Zuzana; Kumar, Saravana

2009-11-30

Previous systematic reviews have found hydrotherapy to be an effective management strategy for fibromyalgia syndrome (FMS). The aim of this systematic review was to summarize the components of hydrotherapy programs used in randomized controlled trials. A systematic review of randomized controlled trials was conducted. Only trials that have reported significant FMS-related outcomes were included. Data relating to the components of hydrotherapy programs (exercise type, duration, frequency and intensity, environmental factors, and service delivery) were analyzed. Eleven randomized controlled trials were included in this review. Overall, the quality of trials was good. Aerobic exercise featured in all 11 trials and the majority of hydrotherapy programs included either a strengthening or flexibility component. Great variability was noted in both the environmental components of hydrotherapy programs and service delivery. Aerobic exercise, warm up and cool-down periods and relaxation exercises are common features of hydrotherapy programs that report significant FMS-related outcomes. Treatment duration of 60 minutes, frequency of three sessions per week and an intensity equivalent to 60%-80% maximum heart rate were the most commonly reported exercise components. Exercise appears to be the most important component of an effective hydrotherapy program for FMS, particularly when considering mental health-related outcomes.

Technology Development and Field Trials of EGS Drilling Systems at Chocolate Mountain

DOE Data Explorer

Steven Knudsen

2012-01-01

Polycrystalline diamond compact (PDC) bits are routinely used in the oil and gas industry for drilling medium to hard rock but have not been adopted for geothermal drilling, largely due to past reliability issues and higher purchase costs. The Sandia Geothermal Research Department has recently completed a field demonstration of the applicability of advanced synthetic diamond drill bits for production geothermal drilling. Two commercially-available PDC bits were tested in a geothermal drilling program in the Chocolate Mountains in Southern California. These bits drilled the granitic formations with significantly better Rate of Penetration (ROP) and bit life than the roller cone bit they are compared with. Drilling records and bit performance data along with associated drilling cost savings are presented herein. The drilling trials have demonstrated PDC bit drilling technology has matured for applicability and improvements to geothermal drilling. This will be especially beneficial for development of Enhanced Geothermal Systems whereby resources can be accessed anywhere within the continental US by drilling to deep, hot resources in hard, basement rock formations.

Monetary incentives in support of academic achievement: results of a randomized field trial involving high-achieving, low-resource, ethnically diverse urban adolescents.

PubMed

Spencer, Margaret Beale; Noll, Elizabeth; Cassidy, Elaine

2005-06-01

Significant resources have been directed at understanding and alleviating the achievement gap in education. Most programs focused on this aim rely on a top-down approach, including funding for infrastructure improvement, curriculum development, class size, and teacher salaries. This article presents findings from a randomized field trial that evaluates a bottom-up approach in which high-achieving students of diverse racial and ethnic backgrounds from poor families are given monetary incentives to maintain their academic standing. The evaluation was designed to explore the role of monetary incentives as a mechanism for promoting resiliency in the face of poverty-related challenge. Discussion of what motivates students to learn is framed as a function of normal cognitive and socioemotional development in challenging environments. Evaluation findings indicate that monetary incentives are effective in promoting academic success to different degrees and for different reasons depending on students' perception of the meaning of the incentive in relation to their emergent identity.

Targeting Matrix Metalloproteinases in Cancer: Bringing New Life to Old Ideas.

PubMed

Cathcart, Jillian; Pulkoski-Gross, Ashleigh; Cao, Jian

2015-03-01

Since the identification of matrix metalloproteinases (MMPs), a family of zinc-dependent endopeptidases, as being a driving factor for cancer progression and patient prognosis, MMPs have been studied extensively. Although early programs targeting MMPs were largely unsuccessful in clinical trials, they remain a viable and highly desirable therapeutic target based on preclinical studies and their role in disease progression. As information regarding the structure and function of these proteinases is compiled and biotechnology evolves, tools to develop better inhibitors is within our grasp. Improved methods for high throughput screening and in silico drug design programs have identified compounds which are highly potent, have high binding affinities, and exhibit favorable pharmacokinetic profiles. More recently, advances in drug delivery methods or compounds which bind outside the active site have brought new light to the field. In this review, we highlight the role of MMPs in cancer, clinical trials for MMP inhibitors, and novel approaches to targeting MMPs in cancer.

Using organization theory to understand the determinants of effective implementation of worksite health promotion programs.

PubMed

Weiner, Bryan J; Lewis, Megan A; Linnan, Laura A

2009-04-01

The field of worksite health promotion has moved toward the development and testing of comprehensive programs that target health behaviors with interventions operating at multiple levels of influence. Yet, observational and process evaluation studies indicate that such programs are challenging for worksites to implement effectively. Research has identified several organizational factors that promote or inhibit effective implementation of comprehensive worksite health promotion programs. However, no integrated theory of implementation has emerged from this research. This article describes a theory of the organizational determinants of effective implementation of comprehensive worksite health promotion programs. The model is adapted from theory and research on the implementation of complex innovations in manufacturing, education and health care settings. The article uses the Working Well Trial to illustrate the model's theoretical constructs. Although the article focuses on comprehensive worksite health promotion programs, the conceptual model may also apply to other types of complex health promotion programs. An organization-level theory of the determinants of effective implementation of worksite health promotion programs.

A comparison of susceptibility to Myxobolus cerebralis among strains of rainbow trout and steelhead in field and laboratory trials

USGS Publications Warehouse

Densmore, Christine L.; Blazer, V.S.; Cartwright, Deborah D.; Schill, W.B.; Schachte, J.H.; Petrie, C.J.; Batur, M.V.; Waldrop, T.B.; Mack, A.; Pooler, P.S.

2001-01-01

Three strains of rainbow trout and steelhead Oncorhynchus mykiss were evaluated for the presence of whirling disease in field and laboratory trials. In the field exposures, fingerling Salmon River steelhead and Cayuga Lake and Randolph strains of rainbow trout were placed in wire cages in an earthen, stream-fed pond in New York State that was known to harbor Myxobolus cerebralis. Control fish were held at another hatchery that was free of whirling disease. In the controlled trials at the National Fish Health Research Laboratory, fingerling steelhead and Cayuga Lake and Mount Lassen rainbow trout were exposed to triactinomyxons at low (200 triactinomyxons/fish) or high (2,000 triactinomyxons/fish) levels for 2 h. Controls of each group were sham-exposed. Following an incubation period of 154 d for laboratory trials and 180 d for field trials, cranial tissue samples were taken for spore enumeration (field and laboratory trials) and histological analyses (laboratory only). Clinical signs of disease, including whirling behavior, blacktail, and skeletal deformities, were recorded for each fish in the laboratory trial at the terminal sampling. No clinical evidence of disease was noted among fish in the field trials. Clinical signs were noted among all strains in the laboratory trials at both exposure levels, and these signs were consistently greatest for the Mount Lassen strain. Whirling and skeletal deformities were more evident in the steelhead than in the Cayuga Lake rainbow trout; blacktail was more common in the Cayuga Lake fish. In both field and laboratory trials, spore counts were significantly higher for Cayuga Lake rainbow trout than in steelhead. In laboratory trials, moderate to marked cranial tissue lesions predominated in all three strains.

Introduction to the Special Issue.

ERIC Educational Resources Information Center

Petrosino, Anthony

2003-01-01

Introduces the articles of this special issue focusing on randomized field trials in criminology. In spite of the overall lack of randomized field trials in criminology, some agencies and individuals are able to mount an impressive number of field trials, and these articles focus on their experiences. (SLD)

The Cryptophlebia Leucotreta Granulovirus—10 Years of Commercial Field Use

PubMed Central

Moore, Sean D.; Kirkman, Wayne; Richards, Garth I.; Stephen, Peter R.

2015-01-01

In the last 15 years, extensive work on the Cryptophlebia leucotreta granulovirus (CrleGV) has been conducted in South Africa, initially in the laboratory, but subsequently also in the field. This culminated in the registration of the first CrleGV-based biopesticide in 2004 (hence, the 10 years of commercial use in the field) and the second one three years later. Since 2000, more than 50 field trials have been conducted with CrleGV against the false codling moth, Thaumatotibia leucotreta, on citrus in South Africa. In a representative sample of 13 field trials reported over this period, efficacy (measured by reduction in larval infestation of fruit) ranged between 30% and 92%. Efficacy was shown to persist at a level of 70% for up to 17 weeks after application of CrleGV. This only occurred where the virus was applied in blocks rather than to single trees. The addition of molasses substantially and sometimes significantly enhanced efficacy. It was also established that CrleGV should not be applied at less than ~2 × 1013 OBs per ha in order to avoid compromised efficacy. As CrleGV-based products were shown to be at least as effective as chemical alternatives, persistent and compatible with natural enemies, their use is recommended within an integrated program for control of T. leucotreta on citrus and other crops. PMID:25809025

Community Agency Survey Formative Research Results From the TAAG Study

PubMed Central

Saunders, Ruth P.; Moody, Jamie

2008-01-01

School and community agency collaboration can potentially increase physical activity opportunities for youth. Few studies have examined the role of community agencies in promoting physical activity, much less in collaboration with schools. This article describes formative research data collection from community agencies to inform the development of the Trial of Activity for Adolescent Girls (TAAG) intervention to provide out-of-school physical activity programs for girls. The community agency survey is designed to assess agency capacity to provide physical activity programs for girls, including resources, programs, and partnerships. Most agency respondents (n = 138) report operations during after-school hours, adequate facilities, and program options for girls, although most are sport oriented. Agency resources and programming vary considerably across the six TAAG field sites. Many agencies report partnerships, some involving schools, although not necessarily related to physical activity. Implications for the TAAG intervention are presented. PMID:16397156

Research Areas - Clinical Trials

Cancer.gov

Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives.

A cross-validation trial of an Internet-based prevention program for alcohol and cannabis: Preliminary results from a cluster randomised controlled trial.

PubMed

Champion, Katrina E; Newton, Nicola C; Stapinski, Lexine; Slade, Tim; Barrett, Emma L; Teesson, Maree

2016-01-01

Replication is an important step in evaluating evidence-based preventive interventions and is crucial for establishing the generalizability and wider impact of a program. Despite this, few replications have occurred in the prevention science field. This study aims to fill this gap by conducting a cross-validation trial of the Climate Schools: Alcohol and Cannabis course, an Internet-based prevention program, among a new cohort of Australian students. A cluster randomized controlled trial was conducted among 1103 students (Mage: 13.25 years) from 13 schools in Australia in 2012. Six schools received the Climate Schools course and 7 schools were randomized to a control group (health education as usual). All students completed a self-report survey at baseline and immediately post-intervention. Mixed-effects regressions were conducted for all outcome variables. Outcomes assessed included alcohol and cannabis use, knowledge and intentions to use these substances. Compared to the control group, immediately post-intervention the intervention group reported significantly greater alcohol (d = 0.67) and cannabis knowledge (d = 0.72), were less likely to have consumed any alcohol (even a sip or taste) in the past 6 months (odds ratio = 0.69) and were less likely to intend on using alcohol in the future (odds ratio = 0.62). However, there were no effects for binge drinking, cannabis use or intentions to use cannabis. These preliminary results provide some support for the Internet-based Climate Schools: Alcohol and Cannabis course as a feasible way of delivering alcohol and cannabis prevention. Intervention effects for alcohol and cannabis knowledge were consistent with results from the original trial; however, analyses of longer-term follow-up data are needed to provide a clearer indication of the efficacy of the intervention, particularly in relation to behavioral changes. © The Royal Australian and New Zealand College of Psychiatrists 2015.

Integrating a suicide prevention program into the primary health care network: a field trial study in Iran.

PubMed

Malakouti, Seyed Kazem; Nojomi, Marzieh; Poshtmashadi, Marjan; Hakim Shooshtari, Mitra; Mansouri Moghadam, Fariba; Rahimi-Movaghar, Afarin; Afghah, Susan; Bolhari, Jafar; Bazargan-Hejazi, Shahrzad

2015-01-01

To describe and evaluate the feasibility of integrating a suicide prevention program with Primary Health Care services and evaluate if such system can improve screening and identification of depressive disorder, reduce number of suicide attempters, and lower rate of suicide completion. This was a quasi-experimental trial in which one community was exposed to the intervention versus the control community with no such exposure. The study sites were two counties in Western Iran. The intervention protocol called for primary care and suicide prevention collaboration at different levels of care. The outcome variables were the number of suicides committed, the number of documented suicide attempts, and the number of identified depressed cases. We identified a higher prevalence of depressive disorders in the intervention site versus the control site (χ (2) = 14.8, P < 0.001). We also found a reduction in the rate of suicide completion in the intervention region compared to the control, but a higher prevalence of suicide attempts in both the intervention and the control sites. Integrating a suicide prevention program with the Primary Health Care network enhanced depression and suicide surveillance capacity and subsequently reduced the number of suicides, especially in rural areas.

An unattended verification station for UF6 cylinders: Field trial findings

NASA Astrophysics Data System (ADS)

Smith, L. E.; Miller, K. A.; McDonald, B. S.; Webster, J. B.; Zalavadia, M. A.; Garner, J. R.; Stewart, S. L.; Branney, S. J.; Todd, L. C.; Deshmukh, N. S.; Nordquist, H. A.; Kulisek, J. A.; Swinhoe, M. T.

2017-12-01

In recent years, the International Atomic Energy Agency (IAEA) has pursued innovative techniques and an integrated suite of safeguards measures to address the verification challenges posed by the front end of the nuclear fuel cycle. Among the unattended instruments currently being explored by the IAEA is an Unattended Cylinder Verification Station (UCVS), which could provide automated, independent verification of the declared relative enrichment, 235U mass, total uranium mass, and identification for all declared uranium hexafluoride cylinders in a facility (e.g., uranium enrichment plants and fuel fabrication plants). Under the auspices of the United States and European Commission Support Programs to the IAEA, a project was undertaken to assess the technical and practical viability of the UCVS concept. The first phase of the UCVS viability study was centered on a long-term field trial of a prototype UCVS system at a fuel fabrication facility. A key outcome of the study was a quantitative performance evaluation of two nondestructive assay (NDA) methods being considered for inclusion in a UCVS: Hybrid Enrichment Verification Array (HEVA), and Passive Neutron Enrichment Meter (PNEM). This paper provides a description of the UCVS prototype design and an overview of the long-term field trial. Analysis results and interpretation are presented with a focus on the performance of PNEM and HEVA for the assay of over 200 "typical" Type 30B cylinders, and the viability of an "NDA Fingerprint" concept as a high-fidelity means to periodically verify that material diversion has not occurred.

Seeking mathematics success for college students: a randomized field trial of an adapted approach

NASA Astrophysics Data System (ADS)

Gula, Taras; Hoessler, Carolyn; Maciejewski, Wes

2015-11-01

Many students enter the Canadian college system with insufficient mathematical ability and leave the system with little improvement. Those students who enter with poor mathematics ability typically take a developmental mathematics course as their first and possibly only mathematics course. The educational experiences that comprise a developmental mathematics course vary widely and are, too often, ineffective at improving students' ability. This trend is concerning, since low mathematics ability is known to be related to lower rates of success in subsequent courses. To date, little attention has been paid to the selection of an instructional approach to consistently apply across developmental mathematics courses. Prior research suggests that an appropriate instructional method would involve explicit instruction and practising mathematical procedures linked to a mathematical concept. This study reports on a randomized field trial of a developmental mathematics approach at a college in Ontario, Canada. The new approach is an adaptation of the JUMP Math program, an explicit instruction method designed for primary and secondary school curriculae, to the college learning environment. In this study, a subset of courses was assigned to JUMP Math and the remainder was taught in the same style as in the previous years. We found consistent, modest improvement in the JUMP Math sections compared to the non-JUMP sections, after accounting for potential covariates. The findings from this randomized field trial, along with prior research on effective education for developmental mathematics students, suggest that JUMP Math is a promising way to improve college student outcomes.

78 FR 7437 - Proposed Collection; Comment Request (60-Day FRN); The Clinical Trials Reporting Program (CTRP...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; Comment Request (60-Day FRN); The Clinical Trials Reporting Program (CTRP) Database (NCI) SUMMARY: In compliance... publication. Proposed Collection: The Clinical Trials Reporting Program (CTRP) Database, 0925-0600, Expiration...

Components of effective randomized controlled trials of hydrotherapy programs for fibromyalgia syndrome: A systematic review

PubMed Central

Perraton, Luke; Machotka, Zuzana; Kumar, Saravana

2009-01-01

Aim Previous systematic reviews have found hydrotherapy to be an effective management strategy for fibromyalgia syndrome (FMS). The aim of this systematic review was to summarize the components of hydrotherapy programs used in randomized controlled trials. Method A systematic review of randomized controlled trials was conducted. Only trials that have reported significant FMS-related outcomes were included. Data relating to the components of hydrotherapy programs (exercise type, duration, frequency and intensity, environmental factors, and service delivery) were analyzed. Results Eleven randomized controlled trials were included in this review. Overall, the quality of trials was good. Aerobic exercise featured in all 11 trials and the majority of hydrotherapy programs included either a strengthening or flexibility component. Great variability was noted in both the environmental components of hydrotherapy programs and service delivery. Conclusions Aerobic exercise, warm up and cool-down periods and relaxation exercises are common features of hydrotherapy programs that report significant FMS-related outcomes. Treatment duration of 60 minutes, frequency of three sessions per week and an intensity equivalent to 60%–80% maximum heart rate were the most commonly reported exercise components. Exercise appears to be the most important component of an effective hydrotherapy program for FMS, particularly when considering mental health-related outcomes. PMID:21197303

A feasibility study and pilot randomised trial of a tailored prevention program to reduce falls in older people with mild dementia

PubMed Central

2013-01-01

Background People with dementia have a disproportionately high rate of falls and fractures and poorer outcomes, yet there is currently no evidence to guide falls prevention in this population. Methods A randomised trial design was used to test feasibility of study components and acceptability of a home hazard reduction and balance and strength exercise fall prevention program. The program was tailored to participant’s individual cognitive levels and implemented as a carer-supported intervention. Feasibility of recruitment, retention and implementation of intervention were recorded through observation and documented in field notes. Adherence, carer burden and use of task simplification strategies were also monitored. Outcome measures, collected at 12 weeks included physiological, fear of falling, cognitive and functional measures. Results Recruitment was achievable but may be more challenging in a multisite trial. Twenty two dyads of persons with mild dementia and their carers were randomised to intervention or usual care control group. Of 38 dyads referred to the study, there was a high rate of willingness to participate, with 6 (16%) declining and 10 (26%) not meeting inclusion criteria. The intervention was well received by participants and carers and adherence to both program components was very good. All participants implemented some home safety recommendations (range 19-80%) with half implementing 50% or more. At the end of 12 weeks, 72% of the intervention group were exercising. Both the rate of falling and the risk of a fall were lower in the intervention group but these findings were not significant (RR= 0.50 (95% CI 0.11-2.19). There were no differences in physiological outcome measures between the control and intervention groups. However results were influenced by the small study size and incomplete data primarily in the intervention group at follow up. Conclusions The pilot study was feasible and acceptable to people with mild dementia and their carers. The lessons learnt included: recruitment for a larger trial will require multiple approaches; home safety recommendations should provide a greater emphasis on environmental use compared with behavioural change; strategies to ensure an adequate dosage of exercise should be further explored. We recommend that intervention delivery incorporate an integrated occupational therapy and physiotherapy approach and that carers be provided with an individualised session to enhance dementia-specific skills in management and communication. A refined intervention should be tested in a randomised trial with an adequately powered sample size. Trial registration Australia and New Zealand Clinical Trials Registry 126100001049066 PMID:24004682

Efficacy vs effectiveness trial results of an indicated "model" substance abuse program: implications for public health.

PubMed

Hallfors, Denise; Cho, Hyunsan; Sanchez, Victoria; Khatapoush, Shereen; Kim, Hyung Min; Bauer, Daniel

2006-12-01

The US Department of Education requires schools to choose substance abuse and violence prevention programs that meet standards of effectiveness. The Substance Abuse and Mental Health Services Agency certifies "model" programs that meet this standard. We compared findings from a large, multisite effectiveness trial of 1 model program to its efficacy trial findings, upon which the certification was based. 1370 high-risk youths were randomized to experimental or control groups across 9 high schools in 2 large urban school districts. We used intent-to-treat and on-treatment approaches to examine baseline equivalence, attrition, and group differences in outcomes at the end of the program and at a 6-month follow-up. Positive efficacy trial findings were not replicated in the effectiveness trial. All main effects were either null or worse for the experimental than for the control group. These findings suggest that small efficacy trials conducted by developers provide insufficient evidence of effectiveness. Federal agencies and public health scientists must work together to raise the standards of evidence and ensure that data from new trials are incorporated into ongoing assessments of program effects.

Yoga in school settings: a research review.

PubMed

Khalsa, Sat Bir S; Butzer, Bethany

2016-06-01

Research on the efficacy of yoga for improving mental, emotional, physical, and behavioral health characteristics in school settings is a recent but growing field of inquiry. This systematic review of research on school-based yoga interventions published in peer-reviewed journals offers a bibliometric analysis that identified 47 publications. The studies from these publications have been conducted primarily in the United States (n = 30) and India (n = 15) since 2005, with the majority of studies (n = 41) conducted from 2010 onward. About half of the publications were of studies at elementary schools; most (85%) were conducted within the school curriculum, and most (62%) also implemented a formal school-based yoga program. There was a high degree of variability in yoga intervention characteristics, including overall duration, and the number and duration of sessions. Most of these published research trials are preliminary in nature, with numerous study design limitations, including limited sample sizes (median = 74; range = 20-660) and relatively weak research designs (57% randomized controlled trials, 19% uncontrolled trials), as would be expected in an infant research field. Nevertheless, these publications suggest that yoga in the school setting is a viable and potentially efficacious strategy for improving child and adolescent health and therefore worthy of continued research. © 2016 New York Academy of Sciences.

State-of-the-science of patient navigation as a strategy for enhancing minority clinical trial accrual.

PubMed

Ghebre, Rahel G; Jones, Lovell A; Wenzel, Jennifer A; Martin, Michelle Y; Durant, Raegan W; Ford, Jean G

2014-04-01

Patient navigation programs are emerging that aim to address disparities in clinical trial participation among medically underserved populations, including racial/ethnic minorities. However, there is a lack of consensus on the role of patient navigators within the clinical trial process as well as outcome measures to evaluate program effectiveness. A review of the literature was conducted of PubMed, Medline, CINHAL, and other sources to identify qualitative and quantitative studies on patient navigation in clinical trials. The search yielded 212 studies, of which only 12 were eligible for this review. The eligible studies reported on the development of programs for patient navigation in cancer clinical trials, including training and implementation among African Americans, American Indians, and Native Hawaiians. A low rate of clinical trial refusal (range, 4%-6%) was reported among patients enrolled in patient navigation programs. However, few studies reported on the efficacy of patient navigation in increasing clinical treatment trial enrollment. Outcome measures are proposed to assist in developing and evaluating the efficacy and/or effectiveness of patient navigation programs that aim to increase participation in cancer clinical trials. Future research is needed to evaluate the efficacy of patient navigators in addressing barriers to clinical trial participation and increasing enrollment among medically underserved cancer patients. © 2014 American Cancer Society.

State-of-the-Science of Patient Navigation as a Strategy for Enhancing Minority Clinical Trial Accrual

PubMed Central

Ghebre, Rahel G.; Jones, Lovell A.; Wenzel, Jennifer; Martin, Michelle Y.; Durant, Raegan; Ford, Jean G.

2014-01-01

Background Patient navigation programs are emerging, that aim to address disparities in clinical trial participation among medically underserved populations, including racial/ethnic minorities. However, there is a lack of consensus on the role of patient navigators within the clinical trial process, as well as outcome measures to evaluate program effectiveness. Methods A review of the literature was conducted of PubMed, Medline, CINHAL, and other sources to identify qualitative and quantitative studies on patient navigation in clinical trials. The search yielded 212 studies, of which only 12 were eligible for this review. Results The eligible studies reported on development of programs for patient navigation in cancer clinical trials, including training and implementation among African American, American Indian and Native Hawaiians. Low clinical trial refusal, 4% to 6%, was reported among patients enrolled in patient navigation program. However, few studies reported on the efficacy of patient navigation on increasing clinical treatment trial enrollment. Conclusion Outcome measures are proposed to assist in developing and evaluating the efficacy and/or effectiveness of patient navigation programs that aim to increase participation in cancer clinical trials. Future research is needed to evaluate the efficacy of patient navigators in addressing barriers to clinical trial participation and increasing enrollment among medically underserved cancer patients. PMID:24643650

Genetic variation in resistance to pine pitch canker and western gall rust in Monterey pine (Pinus radiata D. Don): Results from a three-country collaborative field trial

Treesearch

A.C. Matheson; W.R. Mark; G. Stovold; C. Balocchi; N. Smith; C. Brassey

2012-01-01

In 1998, Australia, Chile, and New Zealand agreed to work together in a program designed to test their elite breeding lines and to test for the genetics of resistance to pitch canker (causative organism Fusarium circinatum). Pitch canker was first discovered in the United States in 1946 and in California in 1986. The first discoveries in California...

The prevention of shin splints in sports: a systematic review of literature.

PubMed

Thacker, Stephen B; Gilchrist, Julie; Stroup, Donna F; Kimsey, C Dexter

2002-01-01

To review the published and unpublished evidence regarding risk factors associated with shin splints, assess the effectiveness of prevention strategies, and offer evidence-based recommendations to coaches, athletes, and researchers. We searched electronic data bases without language restriction, identified citations from reference sections of research papers retrieved, contacted experts in the field, and searched the Cochrane Collaboration. Of the 199 citations identified, we emphasized results of the four reports that compared methods to prevent shin splints. We assessed the methodologic quality of these reports by using a standardized instrument. The use of shock-absorbent insoles, foam heel pads, heel cord stretching, alternative footwear, as well as graduated running programs among military recruits have undergone assessment in controlled trials. There is no strong support for any of these interventions, and each of the four controlled trials is limited methodologically. Median quality scores in these four studies ranged from 29 to 47, and serious flaws in study design, control of bias, and statistical methods were identified. Our review yielded little objective evidence to support widespread use of any existing interventions to prevent shin splints. The most encouraging evidence for effective prevention of shin splints involves the use of shock-absorbing insoles. However, serious flaws in study design and implementation constrain the work in this field thus far. A rigorously implemented research program is critically needed to address this common sports medicine problem.

Meta-analysis of trials of streptococcal throat treatment programs to prevent rheumatic fever.

PubMed

Lennon, Diana; Kerdemelidis, Melissa; Arroll, Bruce

2009-07-01

Rheumatic fever (RF) is the commonest cause of pediatric heart disease globally. Penicillin for streptococcal pharyngitis prevents RF. Inequitable access to health care persists. To investigate RF prevention by treating streptococcal pharyngitis in school- and/or community-based programs. Medline, Old Medline, the Cochrane Library, DARE, Central, NHS, EED, NICE, NRMC, Clinical Evidence, CDC website, PubMed, and reference lists of retrieved articles. Known researchers in the field were contacted where possible. Randomized, controlled trials or trials of before/after design examining treatment of sore throats in schools or communities with RF as an outcome where data were able to be pooled for analysis. Two authors examined titles, abstracts, selected articles, and extracted data. Disagreements were resolved by consensus. QUANTITATIVE ANALYSIS TOOL: Review Manager version 4.2 to assess pooled relative risks and 95% confidence intervals. Six studies (of 677 screened) which met the criteria and could be pooled were included. Meta-analysis of these trials for RF control produced a relative risk of 0.41 (95% CI: 0.23-0.70). There was statistical heterogeneity (I = 70.5%). Hence a random effects analysis was conducted. Many studies were poor quality. Title and available abstracts of non-English studies were checked. There may be publication bias. This is the best available evidence in an area with imperfect information. It is expected acute RF cases would diminish by about 60% using a school or community clinic to treat streptococcal pharyngitis. This should be considered in high-risk populations.

An Effectiveness Trial of a Dissonance-Based Eating Disorder Prevention Program for High-Risk Adolescent Girls

ERIC Educational Resources Information Center

Stice, Eric; Rohde, Paul; Gau, Jeff; Shaw, Heather

2009-01-01

Efficacy trials indicate that an eating disorder prevention program involving dissonance-inducing activities that decrease thin-ideal internalization reduces risk for current and future eating pathology, yet it is unclear whether this program produces effects under real-world conditions. The present effectiveness trial tested whether this program…

42 CFR 460.190 - Monitoring during trial period.

Code of Federal Regulations, 2011 CFR

2011-10-01

... (CONTINUED) PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE) PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE) Federal/State Monitoring § 460.190 Monitoring during trial period. (a) Trial period review...

What is the strength of evidence for heart failure disease-management programs?

PubMed

Clark, Alexander M; Savard, Lori A; Thompson, David R

2009-07-28

Heart failure (HF) disease-management programs are increasingly common. However, some large and recent trials of programs have not reported positive findings. There have also been parallel recent advances in reporting standards and theory around complex nonpharmacological interventions. These developments compel reconsideration in this Viewpoint of how research into HF-management programs should be evaluated, the quality, specificity, and usefulness of this evidence, and the recommendations for future research. Addressing the main determinants of intervention effectiveness by using the PICO (Patient, Intervention, Comparison, and Outcome) approach and the recent CONSORT (Consolidated Standards of Reporting Trials) statement on nonpharmacological trials, we will argue that in both current trials and meta-analyses, interventions and comparisons are not sufficiently well described; that complex programs have been excessively oversimplified; and that potentially salient differences in programs, populations, and settings are not incorporated into analyses. In preference to more general meta-analyses of programs, adequate descriptions are first needed of populations, interventions, comparisons, and outcomes in past and future trials. This could be achieved via a systematic survey of study authors based on the CONSORT statement. These more detailed data on studies should be incorporated into future meta-analyses of comparable trials and used with other techniques such as patient-based outcomes data and meta-regression. Although trials and meta-analyses continue to have potential to generate useful evidence, a more specific evidence base is needed to support the development of effective programs for different populations and settings.

Protocol for a multi-centre randomised controlled trial comparing arthroscopic hip surgery to physiotherapy-led care for femoroacetabular impingement (FAI): the Australian FASHIoN trial.

PubMed

Murphy, Nicholas J; Eyles, Jillian; Bennell, Kim L; Bohensky, Megan; Burns, Alexander; Callaghan, Fraser M; Dickenson, Edward; Fary, Camdon; Grieve, Stuart M; Griffin, Damian R; Hall, Michelle; Hobson, Rachel; Kim, Young Jo; Linklater, James M; Lloyd, David G; Molnar, Robert; O'Connell, Rachel L; O'Donnell, John; O'Sullivan, Michael; Randhawa, Sunny; Reichenbach, Stephan; Saxby, David J; Singh, Parminder; Spiers, Libby; Tran, Phong; Wrigley, Tim V; Hunter, David J

2017-09-26

Femoroacetabular impingement syndrome (FAI), a hip disorder affecting active young adults, is believed to be a leading cause of hip osteoarthritis (OA). Current management approaches for FAI include arthroscopic hip surgery and physiotherapy-led non-surgical care; however, there is a paucity of clinical trial evidence comparing these approaches. In particular, it is unknown whether these management approaches modify the future risk of developing hip OA. The primary objective of this randomised controlled trial is to determine if participants with FAI who undergo hip arthroscopy have greater improvements in hip cartilage health, as demonstrated by changes in delayed gadolinium-enhanced magnetic resonance imaging (MRI) of cartilage (dGEMRIC) index between baseline and 12 months, compared to those who undergo physiotherapy-led non-surgical management. This is a pragmatic, multi-centre, two-arm superiority randomised controlled trial comparing hip arthroscopy to physiotherapy-led management for FAI. A total of 140 participants with FAI will be recruited from the clinics of participating orthopaedic surgeons, and randomly allocated to receive either surgery or physiotherapy-led non-surgical care. The surgical intervention involves arthroscopic FAI surgery from one of eight orthopaedic surgeons specialising in this field, located in three different Australian cities. The physiotherapy-led non-surgical management is an individualised physiotherapy program, named Personalised Hip Therapy (PHT), developed by a panel to represent the best non-operative care for FAI. It entails at least six individual physiotherapy sessions over 12 weeks, and up to ten sessions over six months, provided by experienced musculoskeletal physiotherapists trained to deliver the PHT program. The primary outcome measure is the change in dGEMRIC score of a ROI containing both acetabular and femoral head cartilages at the chondrolabral transitional zone of the mid-sagittal plane between baseline and 12 months. Secondary outcomes include patient-reported outcomes and several structural and biomechanical measures relevant to the pathogenesis of FAI and development of hip OA. Interventions will be compared by intention-to-treat analysis. The findings will help determine whether hip arthroscopy or an individualised physiotherapy program is superior for the management of FAI, including for the prevention of hip OA. Australia New Zealand Clinical Trials Registry reference: ACTRN12615001177549 . Trial registered 2/11/2015 (retrospectively registered).

76 FR 48119 - Oral Rabies Vaccine Trial; Availability of a Risk Assessment and an Environmental Assessment

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-08

...] Oral Rabies Vaccine Trial; Availability of a Risk Assessment and an Environmental Assessment AGENCY... environmental assessment relative to an oral rabies vaccination field trial in West Virginia. The environmental... rabies vaccine, analyzes the use of that vaccine in field safety and efficacy trials in West Virginia...

Evaluation of a prototype interactive consent program for pediatric clinical trials: a pilot study

PubMed Central

Voepel-Lewis, Terri; McGonegal, Maureen; Levine, Robert

2011-01-01

Standard written methods of presenting research information may be difficult for many parents and children to understand. This pilot study was designed to examine the use of a novel prototype interactive consent program for describing a hypothetical pediatric asthma trial to parents and children. Parents and children were interviewed to examine their baseline understanding of key elements of a clinical trial, eg, randomization, placebo, and blinding. Subjects then reviewed age-appropriate versions of an interactive computer program describing an asthma trial, and their understanding of key research concepts was again tested along with their understanding of the details of the trial. Parents and children also completed surveys to examine their perceptions and satisfaction with the program. Both parents and children demonstrated improved understanding of key research concepts following administration of the consent program. For example, the percentage of parents and children who could correctly define the terms clinical trials and placebo improved from 60% to 80%, and 80% to 100% among parents and 25% to 50% and 0% to 50% among children, respectively, following review of the interactive programs. Parents and children's overall understanding of the details of the asthma trial were 14.2±0.84 and 9.25±4.9 (0–15 scale, where 15 is complete understanding), respectively. Results also suggest that the interactive programs were easy to use and facilitated understanding of the clinical trial among parents and children. Interactive media may offer an effective means of presenting understandable information to parents and children regarding participation in clinical trials. Further work to examine this novel approach appears warranted. PMID:21803924

Field trials of solid triple lure (trimedlure, methyl eugenol, raspberry ketone, and DDVP) dispensers for detection and male annihilation of Ceratitis capitata, Bactrocera dorsalis, and Bactrocera cucurbitae (Diptera: Tephritidae) in Hawaii.

PubMed

Vargas, Roger I; Souder, Steven K; Mackey, Bruce; Cook, Peter; Morse, Joseph G; Stark, John D

2012-10-01

Solid Mallet TMR (trimedlure [TML], methyl eugenol [ME], raspberry ketone [RK]) wafers and Mallet CMR (ceralure, ME, RK, benzyl acetate) wafers impregnated with DDVP (2,2-dichlorovinyl dimethyl phosphate) insecticide were measured in traps as potential detection and male annihilation technique (MAT) devices. Comparisons were made with 1) liquid lure and insecticide formulations, 2) solid cones and plugs with an insecticidal strip, and 3) solid single and double lure wafers with DDVP for captures of Mediterranean fruit fly, Ceratitis capitata (Wiedemann); oriental fruit fly, Bactrocera dorsalis Hendel; and melon fly, B. cucurbitae Coquillett. Bucket and Jackson traps were tested in a coffee plantation near Eleele, Kauai Island, HI (trials at high populations) and avocado orchards near Kona, HI Island, HI (trials at low populations). Captures of all three species with Mallet TMR were not different from Mallet CMR; therefore, subsequent experiments did not include Mallet CMR because of higher production costs. In MAT trials near Eleele, HI captures in AWPM traps with Mallet TMR wafers were equal to any other solid lure (single or double) except the Mallet ME wafer. In survey trials near Kona, captures of C. capitata, B. cucurbitae, and B. dorsalis with Mallet TMR wafers were equal to those for the standard TML, ME, and C-L traps used in FL and CA. A solid Mallet TMR wafer is safer, more convenient to handle, and may be used in place of several individual lure and trap systems, potentially reducing costs of large survey and detection programs in Florida and California, and MAT programs in Hawaii.

Web-Based Intervention to Reduce Substance Abuse and Depressive Symptoms in Mexico: Development and Usability Test

PubMed Central

2016-01-01

Background The development of Web-based interventions for substance abuse in Latin America is a new field of interest with great potential for expansion to other Spanish-speaking countries. Objective This paper describes a project aimed to develop and evaluate the usability of the Web-based Help Program for Drug Abuse and Depression (Programa de Ayuda para Abuso de Drogas y Depresión, PAADD, in Spanish) and also to construct a systematic frame of reference for the development of future Web-based programs. Methods The PAADD aims to reduce substance use and depressive symptoms with cognitive behavioral techniques translated into Web applications, aided by the participation of a counselor to provide support and guidance. This Web-based intervention includes 4 steps: (1) My Starting Point, (2) Where Do I Want to Be? (3) Strategies for Change, and (4) Maintaining Change. The development of the program was an interactive multistage process. The first stage defined the core structure and contents, which were validated in stage 2 by a group of 8 experts in addiction treatment. Programming of the applications took place in stage 3, taking into account 3 types of end users: administrators, counselors, and substance users. Stage 4 consisted of functionality testing. In stage 5, a total of 9 health professionals and 20 drug users currently in treatment voluntarily interacted with the program in a usability test, providing feedback about adjustments needed to improve users’ experience. Results The main finding of stage 2 was the consensus of the health professionals about the cognitive behavioral strategies and techniques included in PAADD being appropriate for changing substance use behaviors. In stage 5, the health professionals found the functionalities easy to learn; their suggestions were related to the page layout, inclusion of confirmation messages at the end of activities, avoiding “read more” links, and providing feedback about every activity. On the other hand, the users said the information presented within the modules was easy to follow and suggested more dynamic features with concrete instructions and feedback. Conclusions The resulting Web-based program may have advantages over traditional face-to-face therapies owing to its low cost, wide accessibility, anonymity, and independence of time and distance factors. The detailed description of the process of designing a Web-based program is an important contribution to others interested in this field. The potential benefits must be verified in specific studies. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 25429892; http://www.controlled-trials.com/ISRCTN25429892 (Archived by WebCite at http://www.webcitation.org/6ko1Fsvym) PMID:27687965

Creating and field-testing diagnostic criteria for partner and child maltreatment.

PubMed

Heyman, Richard E; Smith Slep, Amy M

2006-09-01

An integrated set of diagnostic criteria for partner abuse and child abuse and neglect were developed and tested in 4 studies conducted with a branch of America's largest family maltreatment protection agency (i.e., the U.S. military's Family Advocacy Program). Maltreatment criteria then in force were found to have adequate levels of content validity, but experts' and users' feedback indicated ambiguities and poorly specified criteria that undermined reliable application. Criteria incorporating elements of the best existing civilian and military operationalizations were developed and evaluated in two field trials. The final definitions were found to support very high levels of agreement (92%) between base adjudicating committees and master reviewers. Copyright (c) 2006 APA, all rights reserved.

Assessing Clinical Trial-Associated Workload in Community-Based Research Programs Using the ASCO Clinical Trial Workload Assessment Tool.

PubMed

Good, Marjorie J; Hurley, Patricia; Woo, Kaitlin M; Szczepanek, Connie; Stewart, Teresa; Robert, Nicholas; Lyss, Alan; Gönen, Mithat; Lilenbaum, Rogerio

2016-05-01

Clinical research program managers are regularly faced with the quandary of determining how much of a workload research staff members can manage while they balance clinical practice and still achieve clinical trial accrual goals, maintain data quality and protocol compliance, and stay within budget. A tool was developed to measure clinical trial-associated workload, to apply objective metrics toward documentation of work, and to provide clearer insight to better meet clinical research program challenges and aid in balancing staff workloads. A project was conducted to assess the feasibility and utility of using this tool in diverse research settings. Community-based research programs were recruited to collect and enter clinical trial-associated monthly workload data into a web-based tool for 6 consecutive months. Descriptive statistics were computed for self-reported program characteristics and workload data, including staff acuity scores and number of patient encounters. Fifty-one research programs that represented 30 states participated. Median staff acuity scores were highest for staff with patients enrolled in studies and receiving treatment, relative to staff with patients in follow-up status. Treatment trials typically resulted in higher median staff acuity, relative to cancer control, observational/registry, and prevention trials. Industry trials exhibited higher median staff acuity scores than trials sponsored by the National Institutes of Health/National Cancer Institute, academic institutions, or others. The results from this project demonstrate that trial-specific acuity measurement is a better measure of workload than simply counting the number of patients. The tool was shown to be feasible and useable in diverse community-based research settings. Copyright © 2016 by American Society of Clinical Oncology.

In-App Reflection Guidance: Lessons Learned Across Four Field Trials at the Workplace

ERIC Educational Resources Information Center

Fessl, Angela; Wesiak, Gudrun; Rivera-Pelayo, Verónica; Feyertag, Sandra; Pammer, Viktoria

2017-01-01

This paper presents a concept for in-app reflection guidance and its evaluation in four work-related field trials. By synthesizing across four field trials, we can show that computer-based reflection guidance can function in the workplace, in the sense of being accepted as technology, being perceived as useful and leading to reflective learning.…

InterGeo II: International Geographical Achievement Test. Field Trials Report and Test (Secondary Schools, Grade 8).

ERIC Educational Resources Information Center

Niemz, Gunter; Stoltman, Joseph P.

InterGeo II, a project of the Commission on Geographical Education (CGE) of the International Geographical Union (IGU), has developed a broadly based, field-trialed testing instrument for making cross-national comparisons of achievement in geography. Field trials of InterGeo II were held in 23 countries. Data were analyzed for national achievement…

Program History

Cancer.gov

Learn how the National Cancer Institute transitioned the former Cooperative Groups Program to the National Clinical Trials Network (NCTN) program. The NCTN gives funds and other support to cancer research organizations to conduct cancer clinical trials.

Web-based education in systems-based practice: a randomized trial.

PubMed

Kerfoot, B Price; Conlin, Paul R; Travison, Thomas; McMahon, Graham T

2007-02-26

All accredited US residency programs are expected to offer curricula and evaluate their residents in 6 general competencies. Medical schools are now adopting similar competency frameworks. We investigated whether a Web-based program could effectively teach and assess elements of systems-based practice. We enrolled 276 medical students and 417 residents in the fields of surgery, medicine, obstetrics-gynecology, and emergency medicine in a 9-week randomized, controlled, crossover educational trial. Participants were asked to sequentially complete validated Web-based modules on patient safety and the US health care system. The primary outcome measure was performance on a 26-item validated online test administered before, between, and after the participants completed the modules. Six hundred forty (92.4%) of the 693 enrollees participated in the study; 512 (80.0%) of the participants completed all 3 tests. Participants' test scores improved significantly after completion of the first module (P<.001). Overall learning from the 9-week Web-based program, as measured by the increase in scores (posttest scores minus pretest scores), was 16 percentage points (95% confidence interval, 14-17 percentage points; P<.001) in public safety topics and 22 percentage points (95% confidence interval, 20-23 percentage points; P<.001) in US health care system topics. A Web-based educational program on systems-based practice competencies generated significant and durable learning across a broad range of medical students and residents.

An unattended verification station for UF 6 cylinders: Field trial findings

DOE PAGES

Smith, L. E.; Miller, K. A.; McDonald, B. S.; ...

2017-08-26

In recent years, the International Atomic Energy Agency (IAEA) has pursued innovative techniques and an integrated suite of safeguards measures to address the verification challenges posed by the front end of the nuclear fuel cycle. Among the unattended instruments currently being explored by the IAEA is an Unattended Cylinder Verification Station (UCVS), which could provide automated, independent verification of the declared relative enrichment, 235U mass, total uranium mass, and identification for all declared uranium hexafluoride cylinders in a facility (e.g., uranium enrichment plants and fuel fabrication plants). Under the auspices of the United States and European Commission Support Programs tomore » the IAEA, a project was undertaken to assess the technical and practical viability of the UCVS concept. The first phase of the UCVS viability study was centered on a long-term field trial of a prototype UCVS system at a fuel fabrication facility. A key outcome of the study was a quantitative performance evaluation of two nondestructive assay (NDA) methods being considered for inclusion in a UCVS: Hybrid Enrichment Verification Array (HEVA), and Passive Neutron Enrichment Meter (PNEM). This paper provides a description of the UCVS prototype design and an overview of the long-term field trial. In conclusion, analysis results and interpretation are presented with a focus on the performance of PNEM and HEVA for the assay of over 200 “typical” Type 30B cylinders, and the viability of an “NDA Fingerprint” concept as a high-fidelity means to periodically verify that material diversion has not occurred.« less

An unattended verification station for UF 6 cylinders: Field trial findings

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

Smith, L. E.; Miller, K. A.; McDonald, B. S.

In recent years, the International Atomic Energy Agency (IAEA) has pursued innovative techniques and an integrated suite of safeguards measures to address the verification challenges posed by the front end of the nuclear fuel cycle. Among the unattended instruments currently being explored by the IAEA is an Unattended Cylinder Verification Station (UCVS), which could provide automated, independent verification of the declared relative enrichment, 235U mass, total uranium mass, and identification for all declared uranium hexafluoride cylinders in a facility (e.g., uranium enrichment plants and fuel fabrication plants). Under the auspices of the United States and European Commission Support Programs tomore » the IAEA, a project was undertaken to assess the technical and practical viability of the UCVS concept. The first phase of the UCVS viability study was centered on a long-term field trial of a prototype UCVS system at a fuel fabrication facility. A key outcome of the study was a quantitative performance evaluation of two nondestructive assay (NDA) methods being considered for inclusion in a UCVS: Hybrid Enrichment Verification Array (HEVA), and Passive Neutron Enrichment Meter (PNEM). This paper provides a description of the UCVS prototype design and an overview of the long-term field trial. In conclusion, analysis results and interpretation are presented with a focus on the performance of PNEM and HEVA for the assay of over 200 “typical” Type 30B cylinders, and the viability of an “NDA Fingerprint” concept as a high-fidelity means to periodically verify that material diversion has not occurred.« less

Technology and Information Tool Preferences of Academics in the Field of Anaesthesiology

PubMed Central

Akkaya, Akcan; Bilgi, Murat; Demirhan, Abdullah; Kurt, Adem Deniz; Tekelioğlu, Ümit Yaşar; Akkaya, Kadir; Koçoğlu, Hasan; Tekçe, Hikmet

2014-01-01

Objective Researchers use a large number of information technology tools from the beginning until the publication of a scientific study. The aim of the study is to investigate the technology and data processing tool usage preferences of academics who produce scientific publications in the field of anaesthesiology. Methods A multiple-choice survey, including 18 questions regarding the use of technology to assess the preferences of academicians, was performed. Results PubMed has been the most preferred article search portal, and the second is Google Academic. Medscape has become the most preferred medical innovation tracking website. Only 12% of academicians obtain a clinical trial registration number for their randomized clinical research. In total, 28% of respondents used the Consolidated Standards of Reporting Trials checklist in their clinical trials. Of all participants, 21% was using Dropbox and 9% was using Google-Drive for sharing files. Google Chrome was the most preferred internet browser (32.25%) for academic purposes. English language editing service was obtained from the Scribendi (21%) and Textcheck (12%) websites. Half of the academics were getting help from their specialist with a personal relationship, 27% was doing it themselves, and 24% was obtaining professional assistance for statistical requirements. Sixty percent of the participants were not using a reference editing program, and 21% was using EndNote. Nine percent of the academics were spending money for article writing, and the mean cost was 1287 Turkish Liras/year. Conclusion Academics in the field of anaesthesiology significantly benefit from technology and informatics tools to produce scientific publications. PMID:27366448

Disaggregating sorghum yield reductions under warming scenarios exposes narrow genetic diversity in US breeding programs

PubMed Central

Tack, Jesse; Lingenfelser, Jane; Jagadish, S. V. Krishna

2017-01-01

Historical adaptation of sorghum production to arid and semiarid conditions has provided promise regarding its sustained productivity under future warming scenarios. Using Kansas field-trial sorghum data collected from 1985 to 2014 and spanning 408 hybrid cultivars, we show that sorghum productivity under increasing warming scenarios breaks down. Through extensive regression modeling, we identify a temperature threshold of 33 °C, beyond which yields start to decline. We show that this decline is robust across both field-trial and on-farm data. Moderate and higher warming scenarios of 2 °C and 4 °C resulted in roughly 17% and 44% yield reductions, respectively. The average reduction across warming scenarios from 1 to 5 °C is 10% per degree Celsius. Breeding efforts over the last few decades have developed high-yielding cultivars with considerable variability in heat resilience, but even the most tolerant cultivars did not offer much resilience to warming temperatures. This outcome points to two concerns regarding adaption to global warming, the first being that adaptation will not be as simple as producers’ switching among currently available cultivars and the second being that there is currently narrow genetic diversity for heat resilience in US breeding programs. Using observed flowering dates and disaggregating heat-stress impacts, both pre- and postflowering stages were identified to be equally important for overall yields. These findings suggest the adaptation potential for sorghum under climate change would be greatly facilitated by introducing wider genetic diversity for heat resilience into ongoing breeding programs, and that there should be additional efforts to improve resilience during the preflowering phase. PMID:28808013

The effect of paramedic training on pre-hospital trauma care (EPPTC-study): a study protocol for a prospective semi-qualitative observational trial

PubMed Central

2014-01-01

Background Accidents are the leading cause of death in adults prior to middle age. The care of severely injured patients is an interdisciplinary challenge. Limited evidence is available concerning pre-hospital trauma care training programs and the advantage of such programs for trauma patients. The effect on trauma care procedures or on the safety of emergency crews on the scene is limited; however, there is a high level of experience and expert opinion. Methods I – Video-recorded case studies are the basis of an assessment tool and checklist being developed to verify the results of programs to train participants in the care of seriously injured patients, also known as “objective structured clinical examination” (OSCE). The timing, completeness and quality of the individual measures are assessed using appropriate scales. The evaluation of team communication and interaction will be analyzed with qualitative methods and quantified and verified by existing instruments (e.g. the Clinical Team Scale). The developed assessment tool is validated by several experts in the fields of trauma care, trauma research and medical education. II a) In a German emergency medical service, the subjective assessment of paramedics of their pre-hospital care of trauma patients is evaluated at three time points, namely before, immediately after and one year after training. b) The effect of a standardized course concept on the quality of documentation in actual field operations is determined based on three items relevant to patient safety before and after the course. c) The assessment tool will be used to assess the effect of a standardized course concept on procedures and team communication in pre-hospital trauma care using scenario-based case studies. Discussion This study explores the effect of training on paramedics. After successful study completion, further multicenter studies are conceivable, which would evaluate emergency-physician staffed teams. The influence on the patients and prehospital measures should be assessed based on a retrospective analysis of the emergency room data. Trials registration German Clinical Trials Register, ID DRKS00004713. PMID:24528532

[Development of clinical trial education program for pharmaceutical science students through small group discussion and role-playing using protocol].

PubMed

Imakyure, Osamu; Shuto, Hideki; Nishikawa, Fumi; Hagiwara, Yoshifuka; Inoue, Sachiko; Koyanagi, Taeko; Hirakawa, Masaaki; Kataoka, Yasufumi

2010-08-01

The acquirement of basic knowledge of clinical trials and professional attitude in their practices is a general instructional objective in the Model Core Curriculum for Pharmaceutical Education. Unfortunately, the previous program of clinical trial education was not effective in the acquirement of a professional attitude in their practices. Then, we developed the new clinical trial education program using protocol through small group discussion (SGD) and roll-playing. Our program consists of 7 steps of practical training. In step 1, the students find some problems after presentation of the protocol including case and prescription. In step 2, they analyse the extracted problems and share the information obtained in SGD. In steps 3 and 5, five clinical case scenarios are presented to the students and they discuss which case is suitable for entry to the clinical trial or which case corresponds to the discontinuance criteria in the present designed protocol. In steps 4 and 6, the roll-playing is performed by teachers and students as doctors and clinical research coordinators (CRC) respectively. Further, we conducted a trial practice based on this program for the students. In the student's self-evaluation into five grades, the average score of the skill acquisition level in each step was 3.8-4.7 grade. Our clinical trial education program could be effective in educating the candidates for CRC or clinical pharmacists.

A feasibility study and pilot randomised trial of a tailored prevention program to reduce falls in older people with mild dementia.

PubMed

Wesson, Jacqueline; Clemson, Lindy; Brodaty, Henry; Lord, Stephen; Taylor, Morag; Gitlin, Laura; Close, Jacqueline

2013-09-03

People with dementia have a disproportionately high rate of falls and fractures and poorer outcomes, yet there is currently no evidence to guide falls prevention in this population. A randomised trial design was used to test feasibility of study components and acceptability of a home hazard reduction and balance and strength exercise fall prevention program. The program was tailored to participant's individual cognitive levels and implemented as a carer-supported intervention. Feasibility of recruitment, retention and implementation of intervention were recorded through observation and documented in field notes. Adherence, carer burden and use of task simplification strategies were also monitored. Outcome measures, collected at 12 weeks included physiological, fear of falling, cognitive and functional measures. Recruitment was achievable but may be more challenging in a multisite trial. Twenty two dyads of persons with mild dementia and their carers were randomised to intervention or usual care control group. Of 38 dyads referred to the study, there was a high rate of willingness to participate, with 6 (16%) declining and 10 (26%) not meeting inclusion criteria. The intervention was well received by participants and carers and adherence to both program components was very good. All participants implemented some home safety recommendations (range 19-80%) with half implementing 50% or more. At the end of 12 weeks, 72% of the intervention group were exercising. Both the rate of falling and the risk of a fall were lower in the intervention group but these findings were not significant (RR= 0.50 (95% CI 0.11-2.19). There were no differences in physiological outcome measures between the control and intervention groups. However results were influenced by the small study size and incomplete data primarily in the intervention group at follow up. The pilot study was feasible and acceptable to people with mild dementia and their carers. The lessons learnt included: recruitment for a larger trial will require multiple approaches; home safety recommendations should provide a greater emphasis on environmental use compared with behavioural change; strategies to ensure an adequate dosage of exercise should be further explored. We recommend that intervention delivery incorporate an integrated occupational therapy and physiotherapy approach and that carers be provided with an individualised session to enhance dementia-specific skills in management and communication. A refined intervention should be tested in a randomised trial with an adequately powered sample size. Australia and New Zealand Clinical Trials Registry 126100001049066.

The influence of an uncertain force environment on reshaping trial-to-trial motor variability.

PubMed

Izawa, Jun; Yoshioka, Toshinori; Osu, Rieko

2014-09-10

Motor memory is updated to generate ideal movements in a novel environment. When the environment changes every trial randomly, how does the brain incorporate this uncertainty into motor memory? To investigate how the brain adapts to an uncertain environment, we considered a reach adaptation protocol where individuals practiced moving in a force field where a noise was injected. After they had adapted, we measured the trial-to-trial variability in the temporal profiles of the produced hand force. We found that the motor variability was significantly magnified by the adaptation to the random force field. Temporal profiles of the motor variance were significantly dissociable between two different types of random force fields experienced. A model-based analysis suggests that the variability is generated by noise in the gains of the internal model. It further suggests that the trial-to-trial motor variability magnified by the adaptation in a random force field is generated by the uncertainty of the internal model formed in the brain as a result of the adaptation.

Optimal Implantable Cardioverter Defibrillator Programming.

PubMed

Shah, Bindi K

Optimal programming of implantable cardioverter defibrillators (ICDs) is essential to appropriately treat ventricular tachyarrhythmias and to avoid unnecessary and inappropriate shocks. There have been a series of large clinical trials evaluating tailored programming of ICDs. We reviewed the clinical trials evaluating ICD therapies and detection, and the consensus statement on ICD programming. In doing so, we found that prolonged ICD detection times, higher rate cutoffs, and antitachycardia pacing (ATP) programming decreases inappropriate and painful therapies in a primary prevention population. The use of supraventricular tachyarrhythmia discriminators can also decrease inappropriate shocks. Tailored ICD programming using the knowledge gained from recent ICD trials can decrease inappropriate and unnecessary ICD therapies and decrease mortality.

Integrating a Suicide Prevention Program into the Primary Health Care Network: A Field Trial Study in Iran

PubMed Central

Malakouti, Seyed Kazem; Nojomi, Marzieh; Poshtmashadi, Marjan; Hakim Shooshtari, Mitra; Mansouri Moghadam, Fariba; Rahimi-Movaghar, Afarin; Afghah, Susan; Bolhari, Jafar; Bazargan-Hejazi, Shahrzad

2015-01-01

Objective. To describe and evaluate the feasibility of integrating a suicide prevention program with Primary Health Care services and evaluate if such system can improve screening and identification of depressive disorder, reduce number of suicide attempters, and lower rate of suicide completion. Methodology. This was a quasi-experimental trial in which one community was exposed to the intervention versus the control community with no such exposure. The study sites were two counties in Western Iran. The intervention protocol called for primary care and suicide prevention collaboration at different levels of care. The outcome variables were the number of suicides committed, the number of documented suicide attempts, and the number of identified depressed cases. Results. We identified a higher prevalence of depressive disorders in the intervention site versus the control site (χ 2 = 14.8, P < 0.001). We also found a reduction in the rate of suicide completion in the intervention region compared to the control, but a higher prevalence of suicide attempts in both the intervention and the control sites. Conclusion. Integrating a suicide prevention program with the Primary Health Care network enhanced depression and suicide surveillance capacity and subsequently reduced the number of suicides, especially in rural areas. PMID:25648221

Assessing the outcomes of prolonged cessation-induction and aid-to-cessation trials: floating prolonged abstinence.

PubMed

Aveyard, Paul; Wang, Dechao; Connock, Martin; Fry-Smith, Anne; Barton, Pelham; Moore, David

2009-05-01

A Society for Research on Nicotine and Tobacco working group recommended outcome measures for cessation-induction trials and aid-to-cessation trials. Cessation-induction trials aim to motivate unwilling quitters to make a quit attempt. Aid-to-cessation trials give either medication or behavioral interventions to increase the rate at which willing quitters succeed in their attempts. Nicotine-assisted reduction programs combine features of both types of interventions by giving nicotine replacement to unwilling quitters. Treatment can be prolonged more than a year, quit attempts can occur and succeed early or late in the program, and renewed quit attempts are an inherent part of the program. Conventional outcome measures are tied to a fixed but arbitrary point in follow-up and cannot capture the true outcome: Prolonged cessation anchored to the point at which a person makes a successful quit attempt. We propose that the outcome should be counted from the successful quit attempt that began during the treatment period and continues for a defined period, ideally 6 months. In particular, if a trial compared a short reduction program with a long reduction program, it would not be possible to obtain an unbiased assessment of the outcome of such a trial using a measure tied to a fixed point in follow-up. Floating prolonged abstinence could provide such an assessment and is suitable for either prolonged cessation-induction trial or combined cessation-induction and aid-to-cessation trials.

Strengthening government health and family planning programs: findings from an action research project in rural Bangladesh.

PubMed

Simmons, R; Phillips, J F; Rahman, M

1984-01-01

An ongoing study at the International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B) is based on the premise that public sector health and family planning programs can be improved through an assessment of the dysfunctional aspects of their operations, the development of problem-solving capabilities, and the transfer of strategies successfully tested in a small-scale pilot project. This paper reports findings from a field trial implemented in a subunit of the project area at an early stage of the project. Operational barriers to public sector program implementation are discussed with regard to the quantity of work, the quality of work, supplies and facilities, integration of health and family planning, and leadership, supervision, and decision making. Initial results of the ICDDR,B intervention on these managerial processes are also indicated.

Improving precision of forage yield trials: A case study

USDA-ARS?s Scientific Manuscript database

Field-based agronomic and genetic research relies heavily on the data generated from field evaluations. Therefore, it is imperative to optimize the precision of yield estimates in cultivar evaluation trials to make reliable selections. Experimental error in yield trials is sensitive to several facto...

Official 1996 Mock Trial Materials for the Twenty-Fourth Annual District of Columbia Public Schools Mock Trial Program. Kyle Wilkins, Plaintiff, v. New Columbia County School District, Defendant.

ERIC Educational Resources Information Center

Ashbrook, Alexandra M.

This guide contains the 1996 mock trial materials for the District of Columbia mock trial program. The trial focuses on a high school student who died of a heart attack attributed to the use of steroids. The plaintiff, the student's father, alleges that the school, its principal, and track coach were negligent in the death because they failed to…

Can insecticide-treated netting provide protection for Equids from Culicoides biting midges in the United Kingdom?

PubMed

Baker, Tiffany; Carpenter, Simon; Gubbins, Simon; Newton, Richard; Lo Iacono, Giovanni; Wood, James; Harrup, Lara Ellen

2015-11-25

Biting midges of the genus Culicoides Latreille, 1809 (Diptera: Ceratopogonidae) cause a significant biting nuisance to equines and are responsible for the biological transmission of African horse sickness virus (AHSV). While currently restricted in distribution to sub-Saharan Africa, AHSV has a history of emergence into southern Europe and causes one of the most lethal diseases of horses and other species of Equidae. In the event of an outbreak of AHSV, the use of insecticide treated nets (ITNs) to screen equine accomodation is recommended by competent authorities including the Office International des Épizooties (OIE) in order to reduce vector-host contact. Seven commercially avaliable pyrethroid insecticides and three repellent compounds, all of which are licensed for amateur use, were assessed in modified World Health Organization (WHO) cone bioassay trials in the laboratory using a colony line of Culicoides nubeculosus (Meigen), 1830. Two field trials were subsequently conducted to test the efficiency of treated net screens in preventing entry of Culicoides. A formulation of cypermethrin (0.15 % w/w) and pyrethrins (0.2 % w/w) (Tri-Tec 14®, LS Sales (Farnham) Ltd, Bloxham, UK) applied to black polyvinyl-coated polyester insect screen (1.6 mm aperture; 1.6 mm thickness) inflicted 100 % mortality on batches of C. nubeculosus following a three minute exposure in the WHO cone bioassays at 1, 7 and 14 days post-treatment. Tri-Tec 14® outperformed all other treatments tested and was subsequently selected for use in field trials. The first trial demonstrated that treated screens placed around an ultraviolet light-suction trap entirely prevented Culicoides being collected, despite their collection in identical traps with untreated screening or no screening. The second field trial examined entry of Culicoides into stables containing horses and found that while the insecticide treated screens reduced entry substantially, there was still a small risk of exposure to biting. Screened stables can be utilised as part of an integrated control program in the event of an AHSV outbreak in order to reduce vector-host contact and may also be applicable to protection of horses from Culicoides during transport.

The 'Healthy Dads, Healthy Kids' community effectiveness trial: study protocol of a community-based healthy lifestyle program for fathers and their children

PubMed Central

2011-01-01

Background The 'Healthy Dads, Healthy Kids' program was designed to help overweight fathers lose weight and positively influence the health behaviors of their children. The aim of the current study was to evaluate the previously established program in a community setting, in a large effectiveness trial. Methods/Design The Healthy Dads, Healthy Kids community trial consists of three stages: (i) Stage 1 - program refinement and resource development (ii) Stage 2 - community randomized controlled trial (iii) Stage 3 - community effectiveness trial. The program will be evaluated in five Local Government Areas in the Hunter Valley Region of NSW, Australia. For the community randomized controlled trial, 50 overweight/obese men (aged 18-65 years) from one Local Government Area with a child aged between 5-12 years of age will be recruited. Families will be randomized to either the program or a 6-month wait-list control group. Fathers and their children will be assessed at baseline, post-intervention (3-months) and 6-months. Inclusion criteria are: body mass index 25-40 kg/m2; no participation in other weight loss programs during the study; pass a health-screening questionnaire; and access to a computer with Internet facilities. In the community trial, the program will be evaluated using a non-randomized, prospective design in five Local Government Areas. The exclusion criteria is body mass index < 25 kg/m2 or lack of doctor's approval. Measures will be collected at baseline, 3-, 6- and 12-months. The program involves fathers attending seven face-to-face group sessions (three with children) over 3-months. Measures: The primary outcome is fathers' weight. Secondary outcomes for both fathers and children include: waist circumference, blood pressure, resting heart rate, physical activity, sedentary behaviors and dietary intake. Father-only measures include portion size, alcohol consumption, parenting for physical activity and nutrition and parental engagement. Process evaluation will determine the fidelity, dose (delivered and received), reach, recruitment and context of the program. Discussion As a unique approach to reducing obesity prevalence in men and improving lifestyle behaviours in children, our findings will provide important evidence relating to the translation of Healthy Dads, Healthy Kids, which will enable it to be delivered on a larger scale. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12610000608066 PMID:22099889

Benefits of commercial weight-loss programs on blood pressure and lipids: a systematic review.

PubMed

Mehta, Ambereen K; Doshi, Ruchi S; Chaudhry, Zoobia W; Jacobs, David K; Vakil, Rachit M; Lee, Clare J; Bleich, Sara N; Clark, Jeanne M; Gudzune, Kimberly A

2016-09-01

Our objective was to compare the effect of commercial weight-loss programs on blood pressure and lipids to control/education or counseling among individuals with overweight/obesity. We conducted a systematic review by searching MEDLINE and Cochrane Database of Systematic Reviews from inception to November 2014 and references identified by the programs. We included randomized, controlled trials ≥12weeks in duration. Two reviewers extracted information on study design, interventions, and mean change in systolic blood pressure (SBP), diastolic blood pressure (DBP), low-density lipoprotein cholesterol (LDL-c), high-density lipoprotein cholesterol (HDL-c), triglycerides, and total cholesterol and assessed risk of bias. We included 27 trials. Participants' blood pressure and lipids were normal at baseline in most trials. At 12months, Weight Watchers showed little change in blood pressure or lipid outcomes as compared to control/education (2 trials). At 12months, Atkins' participants had higher HDL-c and lower triglycerides than counseling (4 trials). Other programs had inconsistent effects or lacked long-term studies. Risk of bias was high for most trials of all programs. In conclusion, limited data exist regarding most commercial weight-loss programs' long-term effects on blood pressure and lipids. Clinicians should be aware that Weight Watchers has limited data that demonstrate CVD risk factor benefits relative to control/education. Atkins may be a reasonable option for patients with dyslipidemia. Additional well-designed, long-term trials are needed to confirm these conclusions and evaluate other commercial programs. Copyright © 2016 Elsevier Inc. All rights reserved.

Spectroscopic Results from the Life in the Atacama (LITA) Project 2004 Field Season

NASA Technical Reports Server (NTRS)

Piatek, J. L.; Moersch, J. E.; Wyatt, M.; Rampey, M.; Cabrol, N. A.; Wettergreen, D. S.; Whittaker, R.; Grin, E. A.; Diaz, G. Chong

2005-01-01

Introduction: The Life in the Atacama (LITA) project includes rover field tests designed to look for life in the arid environment of the Atacama Desert (Chile). Field instruments were chosen to help remote observers identify potential habitats and the presence of life in these habitats, and included two spectrometers for help in identifying the mineralogy of the field sites. Two field trials were undertaken during the 2004 field season. The remote science team had no prior knowledge of the local geology, and relied entirely on orbital images and rover-acquired data to make interpretations. Each field trial lasted approximately one week: the sites for these trials were in different locations, and are designated "Site B" and "Site C."

Trial Registration at ClinicalTrials.gov between May and October 2005

PubMed Central

Zarin, Deborah A.; Tse, Tony; Ide, Nicholas C.

2006-01-01

BACKGROUND Clinical trial registration allows interested parties to obtain information about ongoing and completed trials, but there are few data indicating the quality of the information provided during the registration process. We used information in the publicly available ClinicalTrials.gov database to describe patterns of trial registration before and after the implementation by journal editors of a new policy requiring registration as a prerequisite for publication. METHODS We reviewed ClinicalTrials.gov records to determine patterns of completion of the “Intervention Name” and “Primary Outcome Measure” data fields for trials registered on May 20 and October 11, 2005, and for trials registered during the interval between these two dates, inclusively. RESULTS During the interval studied, the number of registrations in ClinicalTrials.gov increased by 73 percent from 13,153 to 22,714. The percentage of interventional trials registered by industry with nonspecific Intervention Name entries (attributable to four drug companies) decreased from 10 percent to 2 percent; all other industry and nonindustry records contained specific entries in this field. Of the 2670 studies registered by industry between the two dates, 76 percent provided information in the Primary Outcome Measure field, although these entries varied markedly in their degree of specificity. In the remaining 24 percent of the records, this field was blank. CONCLUSIONS During the summer of 2005, there were large increases in the number of clinical trial registrations. Overall, the data contained in records were more complete in October than they were in May, but there still is room for substantial improvement. PMID:16382064

77 FR 40322 - Oral Rabies Vaccine Trial; Availability of an Environmental Assessment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-09

...] Oral Rabies Vaccine Trial; Availability of an Environmental Assessment AGENCY: Animal and Plant Health... assessment relative to an oral rabies vaccination field trial in New Hampshire, New York, Ohio, Vermont, and West Virginia. The environmental assessment analyzes the use of an experimental rabies vaccine in field...

Entrepreneurship education: A strength-based approach to substance use and suicide prevention for American Indian adolescents.

PubMed

Tingey, Lauren; Larzelere-Hinton, Francene; Goklish, Novalene; Ingalls, Allison; Craft, Todd; Sprengeler, Feather; McGuire, Courtney; Barlow, Allison

2016-01-01

American Indian (AI) adolescents suffer the largest disparities in substance use and suicide. Predominating prevention models focus primarily on risk and utilize deficit-based approaches. The fields of substance use and suicide prevention research urge for positive youth development frameworks that are strength based and target change at individual and community levels. Entrepreneurship education is an innovative approach that reflects the gap in available programs. This paper describes the development and evaluation of a youth entrepreneurship education program in partnership with one AI community. We detail the curriculum, process evaluation results, and the randomized controlled trial evaluating its efficacy for increasing protective factors. Lessons learned may be applicable to other AI communities.

The assessment of field trials in GMO research around the world and their possible integration in field trials for variety registration.

PubMed

Slot, M M; van de Wiel, C C M; Kleter, G A; Visser, R G F; Kok, E J

2018-05-04

Most regulations worldwide stipulate that a new genetically modified (GM) crop event has to be compared to its closest non-GM counterpart as a corner stone of the pre-market risk assessment. To this end the GM crop and its comparator should be grown in field trials for a phenotypic comparison as well as for subsequent detailed analysis of the composition of the two crop varieties. A more in-depth globally harmonised approach for the conduct of these field trials is lacking. Only a few countries have formulated detailed protocols for the set-up of GM field trials. In some countries, commercial non-GM reference varieties need to be included in a field study to compile reliable data that indicate the range of natural variation for the compounds tested at the specific location. Detailed analysis of pre-market assessment reports have so far not shown the added value of including these reference varieties in the field trials. In all cases where specific values were found to be outside of the range of the reference varieties, it proved possible to draw conclusions on the part of the pre-market risk assessment that relates to the compositional analysis, on the basis of already available compositional data. With the increasing quality of several databases on compositional data of a growing number of crop species, it seems unlikely that reference varieties will become more important on future occasions. It was furthermore investigated whether this part of the risk assessment can be related to field trial requirements for variety registration with the explicit intention of reducing the data burden on producers of new GM plant varieties. Field trials for variety registration so far include an assessment of phenotypic characteristics that do not cover safety aspects, with the exception of establishment of the glycoalkaloid content in potatoes in the Netherlands and Sweden. It may, however, under certain conditions be relatively easy to exchange data from compositional measurements between variety registration and GM testing procedures, thus laying a foundation for testing the feasibility of combining both pre-market assessment procedures in a single pre-market evaluation path.

Effectiveness of a Web-Based Self-Help Program for Suicidal Thinking in an Australian Community Sample: Randomized Controlled Trial

PubMed Central

van Spijker, Bregje AJ; Werner-Seidler, Aliza; Batterham, Philip J; Mackinnon, Andrew; Calear, Alison L; Gosling, John A; Reynolds, Julia; Kerkhof, Ad JFM; Solomon, Daniela; Shand, Fiona

2018-01-01

Background Treatment for suicidality can be delivered online, but evidence for its effectiveness is needed. Objective The goal of our study was to examine the effectiveness of an online self-help intervention for suicidal thinking compared to an attention-matched control program. Methods A 2-arm randomized controlled trial was conducted with assessment at postintervention, 6, and, 12 months. Through media and community advertizing, 418 suicidal adults were recruited to an online portal and were delivered the intervention program (Living with Deadly Thoughts) or a control program (Living Well). The primary outcome was severity of suicidal thinking, assessed using the Columbia Suicide Severity Rating Scale. Results Intention-to-treat analyses showed significant reductions in the severity of suicidal thinking at postintervention, 6, and 12 months. However, no overall group differences were found. Conclusions Living with Deadly Thoughts was of no greater effectiveness than the control group. Further investigation into the conditions under which this program may be beneficial is now needed. Limitations of this trial include it being underpowered given the effect size ultimately observed, a high attrition rate, and the inability of determining suicide deaths or of verifying self-reported suicide attempts. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12613000410752; https://www.anzctr.org.au/ Trial/Registration/TrialReview.aspx?id=364016 (Archived by WebCite at http://www.webcitation.org/6vK5FvQXy); Universal Trial Number U1111-1141-6595 PMID:29444769

Caffeine, Adenosine Receptors and Estrogen in Toxin Models of Parkinson’s Disease

DTIC Science & Technology

2008-10-30

these have advanced molecules to clinical studies.2,3 Thus, the NIH clinical trial registry lists over a dozen actively recruiting or completed trials ...into clinical trials ,4 and multiple other preclinical programs are apparently progressing (including publicly announced programs at Neurocrine5 and...unpublished results). Adenosine A2AR antagonists are currently in clinical trials for PD because of their symptom- improving abilities. The

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

PubMed Central

Pahor, Marco; Guralnik, Jack M; McDermott, Mary M; King, Abby C; Buford, Thomas W; Strotmeyer, Elsa S; Nelson, Miriam E; Sink, Kaycee M; Demons, Jamehl L; Kashaf, Susan S; Walkup, Michael P; Miller, Michael E

2016-01-01

Objective To test whether a long term, structured physical activity program compared with a health education program reduces the risk of serious fall injuries among sedentary older people with functional limitations. Design Multicenter, single blinded randomized trial (Lifestyle Interventions and Independence for Elders (LIFE) study). Setting Eight centers across the United States, February 2010 to December 2011. Participants 1635 sedentary adults aged 70-89 years with functional limitations, defined as a short physical performance battery score ≤9, but who were able to walk 400 m. Interventions A permuted block algorithm stratified by field center and sex was used to allocate interventions. Participants were randomized to a structured, moderate intensity physical activity program (n=818) conducted in a center (twice a week) and at home (3-4 times a week) that included aerobic, strength, flexibility, and balance training activities, or to a health education program (n=817) consisting of workshops on topics relevant to older people and upper extremity stretching exercises. Main outcome measures Serious fall injuries, defined as a fall that resulted in a clinical, non-vertebral fracture or that led to a hospital admission for another serious injury, was a prespecified secondary outcome in the LIFE Study. Outcomes were assessed every six months for up to 42 months by staff masked to intervention assignment. All participants were included in the analysis. Results Over a median follow-up of 2.6 years, a serious fall injury was experienced by 75 (9.2%) participants in the physical activity group and 84 (10.3%) in the health education group (hazard ratio 0.90, 95% confidence interval 0.66 to 1.23; P=0.52). These results were consistent across several subgroups, including sex. However, in analyses that were not prespecified, sex specific differences were observed for rates of all serious fall injuries (rate ratio 0.54, 95% confidence interval 0.31 to 0.95 in men; 1.07, 0.75 to 1.53 in women; P=0.043 for interaction), fall related fractures (0.47, 0.25 to 0.86 in men; 1.12, 0.77 to 1.64 in women; P=0.017 for interaction), and fall related hospital admissions (0.41, 0.19 to 0.89 in men; 1.10, 0.65 to 1.88 in women; P=0.039 for interaction). Conclusions In this trial, which was underpowered to detect small, but possibly important reductions in serious fall injuries, a structured physical activity program compared with a health education program did not reduce the risk of serious fall injuries among sedentary older people with functional limitations. These null results were accompanied by suggestive evidence that the physical activity program may reduce the rate of fall related fractures and hospital admissions in men. Trial registration ClinicalsTrials.gov NCT01072500. PMID:26842425

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

PubMed

Gill, Thomas M; Pahor, Marco; Guralnik, Jack M; McDermott, Mary M; King, Abby C; Buford, Thomas W; Strotmeyer, Elsa S; Nelson, Miriam E; Sink, Kaycee M; Demons, Jamehl L; Kashaf, Susan S; Walkup, Michael P; Miller, Michael E

2016-02-03

To test whether a long term, structured physical activity program compared with a health education program reduces the risk of serious fall injuries among sedentary older people with functional limitations. Multicenter, single blinded randomized trial (Lifestyle Interventions and Independence for Elders (LIFE) study). Eight centers across the United States, February 2010 to December 2011. 1635 sedentary adults aged 70-89 years with functional limitations, defined as a short physical performance battery score ≤ 9, but who were able to walk 400 m. A permuted block algorithm stratified by field center and sex was used to allocate interventions. Participants were randomized to a structured, moderate intensity physical activity program (n=818) conducted in a center (twice a week) and at home (3-4 times a week) that included aerobic, strength, flexibility, and balance training activities, or to a health education program (n=817) consisting of workshops on topics relevant to older people and upper extremity stretching exercises. Serious fall injuries, defined as a fall that resulted in a clinical, non-vertebral fracture or that led to a hospital admission for another serious injury, was a prespecified secondary outcome in the LIFE Study. Outcomes were assessed every six months for up to 42 months by staff masked to intervention assignment. All participants were included in the analysis. Over a median follow-up of 2.6 years, a serious fall injury was experienced by 75 (9.2%) participants in the physical activity group and 84 (10.3%) in the health education group (hazard ratio 0.90, 95% confidence interval 0.66 to 1.23; P=0.52). These results were consistent across several subgroups, including sex. However, in analyses that were not prespecified, sex specific differences were observed for rates of all serious fall injuries (rate ratio 0.54, 95% confidence interval 0.31 to 0.95 in men; 1.07, 0.75 to 1.53 in women; P=0.043 for interaction), fall related fractures (0.47, 0.25 to 0.86 in men; 1.12, 0.77 to 1.64 in women; P=0.017 for interaction), and fall related hospital admissions (0.41, 0.19 to 0.89 in men; 1.10, 0.65 to 1.88 in women; P=0.039 for interaction). In this trial, which was underpowered to detect small, but possibly important reductions in serious fall injuries, a structured physical activity program compared with a health education program did not reduce the risk of serious fall injuries among sedentary older people with functional limitations. These null results were accompanied by suggestive evidence that the physical activity program may reduce the rate of fall related fractures and hospital admissions in men.Trial registration ClinicalsTrials.gov NCT01072500. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Method matters: Understanding diagnostic reliability in DSM-IV and DSM-5.

PubMed

Chmielewski, Michael; Clark, Lee Anna; Bagby, R Michael; Watson, David

2015-08-01

Diagnostic reliability is essential for the science and practice of psychology, in part because reliability is necessary for validity. Recently, the DSM-5 field trials documented lower diagnostic reliability than past field trials and the general research literature, resulting in substantial criticism of the DSM-5 diagnostic criteria. Rather than indicating specific problems with DSM-5, however, the field trials may have revealed long-standing diagnostic issues that have been hidden due to a reliance on audio/video recordings for estimating reliability. We estimated the reliability of DSM-IV diagnoses using both the standard audio-recording method and the test-retest method used in the DSM-5 field trials, in which different clinicians conduct separate interviews. Psychiatric patients (N = 339) were diagnosed using the SCID-I/P; 218 were diagnosed a second time by an independent interviewer. Diagnostic reliability using the audio-recording method (N = 49) was "good" to "excellent" (M κ = .80) and comparable to the DSM-IV field trials estimates. Reliability using the test-retest method (N = 218) was "poor" to "fair" (M κ = .47) and similar to DSM-5 field-trials' estimates. Despite low test-retest diagnostic reliability, self-reported symptoms were highly stable. Moreover, there was no association between change in self-report and change in diagnostic status. These results demonstrate the influence of method on estimates of diagnostic reliability. (c) 2015 APA, all rights reserved).

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

PubMed Central

2013-01-01

Background In recent decades, parents have been involved in programs that aim to improve parenting style and reduce child behavior problems. Research of preventive parenting programs has shown that these interventions generally have a positive influence on both parents and children. However, to our knowledge there is a gap in the scientific literature when it comes to randomized controlled trials of brief, manual-based structured programs which address general parenting among the population, and focus on promoting health. A four-session universal health promotion parent group program named All Children in Focus was developed. It aims at promoting parental competence and children’s positive development with the parent–child relationship as the target. There is currently no randomized controlled trial existing of the program. Methods/Design A prospective multicenter randomized wait-list controlled trial is being conducted. Approximately 600 parents with children ranging in age from 3–12 years have been recruited in eleven municipalities and city districts in the County of Stockholm, Sweden. Parents are randomized at baseline to an intervention group, which receives the program directly, or to a waiting-list control group, which participates in the program six months later. Changes in parenting and child health and development are assessed with measures immediately post-intervention and six months after the baseline. Observations of a minor group of parents and children are conducted to explore possible relations between parental reports and observed behaviors, as well as changes in the interaction between parent and child. Further, data collected within the evaluation will also be applied to evaluate the possible cost-effectiveness of the program. Discussion This paper describes a study protocol of a randomized controlled trial. Except for the quantitative outcome measures to evaluate the effectiveness of All Children in Focus, this protocol also describes health economic and qualitative analyses to deepen the knowledge of the program. We further discuss some issues regarding the implementation of the program in municipalities and city districts. Trial registration Current Controlled Trials ISRCTN70202532 PMID:23890316

Culturally-Tailored Smoking Cessation for American Indians: Study protocol for a randomized controlled trial

PubMed Central

2011-01-01

Background Cigarette smoking is the number one cause of preventable death among American Indian and Alaska Natives, AI/ANs. Two out of every five AI/AN will die from tobacco-related diseases if the current smoking rates of AI/ANs (40.8%) persist. Currently, there is no proven, effective culturally-tailored smoking cessation program designed specifically for a heterogeneous population of AI. The primary aim of this group randomized clinical trial is to test the efficacy of "All Nations Breath of Life" (ANBL) program compared to a non-tailored "Current Best Practices" smoking cessation program among AI smokers. Methods We will randomize 56 groups (8 smokers per group) to the tailored program or non-tailored program for a total sample size of 448 American Indian smokers. All participants in the proposed study will be offered pharmacotherapy, regardless of group assignment. This study is the first controlled trial to examine the efficacy of a culturally-tailored smoking cessation program for American Indians. If the intervention is successful, the potential health impact is significant because the prevalence of smoking is the highest in this population. Trial Registration ClinicalTrials.gov: NCT01106456 PMID:21592347

Testing the Replicability of a Successful Care Management Program: Results from a Randomized Trial and Likely Explanations for Why Impacts Did Not Replicate.

PubMed

Peterson, G Greg; Zurovac, Jelena; Brown, Randall S; Coburn, Kenneth D; Markovich, Patricia A; Marcantonio, Sherry A; Clark, William D; Mutti, Anne; Stepanczuk, Cara

2016-12-01

To test whether a care management program could replicate its success in an earlier trial and determine likely explanations for why it did not. Medicare claims and nurse contact data for Medicare fee-for-service beneficiaries with chronic illnesses enrolled in the trial in eastern Pennsylvania (N = 483). A randomized trial with half of enrollees receiving intensive care management services and half receiving usual care. We developed and tested hypotheses for why impacts declined. All outcomes and covariates were derived from claims and the nurse contact data. From 2010 to 2014, the program did not reduce hospitalizations or generate Medicare savings to offset program fees that averaged $260 per beneficiary per month. These estimates are statistically different (p < .05) from the large reductions in hospitalizations and spending in the first trial (2002-2010). The treatment-control differences in the second trial disappeared because the control group's risk-adjusted hospitalization rate improved, not because the treatment group's outcomes worsened. Even if demonstrated in a randomized trial, successful results from one test may not replicate in other settings or time periods. Assessing whether gaps in care that the original program filled exist in other settings can help identify where earlier success is likely to replicate. © Health Research and Educational Trust.

Field trials of 100G and beyond: an operator's point of view

NASA Astrophysics Data System (ADS)

Vorbeck, S.; Schneiders, M.; Weiershausen, W.; Mayer, H.; Schippel, A.; Wagner, P.; Ehrhardt, A.; Braun, R.; Breuer, D.; Drafz, U.; Fritzsche, D.

2011-01-01

In this article we present a summary of the latest 100 Gbps field trials in the network of Deutsche Telekom AG with industry partners. We cover a brown field approach as alien wavelength on existing systems, a green field high speed overlay network approach and a high speed interface router-router coupling.

Mississippi exploration field trials using microbial, radiometrics, free soil gas, and other techniques

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

Moody, J.S.; Brown, L.R.; Thieling, S.C.

1995-12-31

The Mississippi Office of Geology has conducted field trials using the surface exploration techniques of geomicrobial, radiometrics, and free soil gas. The objective of these trials is to determine if Mississippi oil and gas fields have surface hydrocarbon expression resulting from vertical microseepage migration. Six fields have been surveyed ranging in depth from 3,330 ft to 18,500 ft. The fields differ in trapping styles and hydrocarbon type. The results so far indicate that these fields do have a surface expression and that geomicrobial analysis as well as radiometrics and free soil gas can detect hydrocarbon microseepage from pressurized reservoirs. Allmore » three exploration techniques located the reservoirs independent of depth, hydrocarbon type, or trapping style.« less

Content and Evaluation of the Benefits of Effective Exercise for Older Adults With Knee Pain Trial Physiotherapist Training Program.

PubMed

Holden, Melanie A; Whittle, Rebecca; Healey, Emma L; Hill, Susan; Mullis, Ricky; Roddy, Edward; Sowden, Gail; Tooth, Stephanie; Foster, Nadine E

2017-05-01

To explore whether participating in the Benefits of Effective Exercise for knee Pain (BEEP) trial training program increased physiotherapists' self-confidence and changed their intended clinical behavior regarding exercise for knee pain in older adults. Before/after training program evaluation. Physiotherapists were asked to complete a questionnaire before the BEEP trial training program, immediately after, and 12 to 18 months later (postintervention delivery in the BEEP trial). The questionnaire included a case vignette and associated clinical management questions. Questionnaire responses were compared over time and between physiotherapists trained to deliver each intervention within the BEEP trial. Primary care. Physiotherapists (N=53) who completed the BEEP trial training program. Not applicable. Self-confidence in the diagnosis and management of knee pain in older adults; and intended clinical behavior measured by a case vignette and associated clinical management questions. Fifty-two physiotherapists (98%) returned the pretraining questionnaire, and 44 (85%) and 39 (74%) returned the posttraining and postintervention questionnaires, respectively. Posttraining, self-confidence in managing older adults with knee pain increased, and intended clinical behavior regarding exercise for knee pain in older adults appeared more in line with clinical guidelines. However, not all positive changes were maintained in the longer-term. Participating in the BEEP trial training program increased physiotherapists' self-confidence and changed their intended clinical behavior regarding exercise for knee pain, but by 12 to 18 months later, some of these positive changes were lost. This suggests that brief training programs are useful, but additional strategies are likely needed to successfully maintain changes in clinical behavior over time. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Feasibility and acceptability of the DSM-5 Field Trial procedures in the Johns Hopkins Community Psychiatry Programs†

PubMed Central

Clarke, Diana E.; Wilcox, Holly C.; Miller, Leslie; Cullen, Bernadette; Gerring, Joan; Greiner, Lisa H.; Newcomer, Alison; Mckitty, Mellisha V.; Regier, Darrel A.; Narrow, William E.

2014-01-01

The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) contains criteria for psychiatric diagnoses that reflect advances in the science and conceptualization of mental disorders and address the needs of clinicians. DSM-5 also recommends research on dimensional measures of cross-cutting symptoms and diagnostic severity, which are expected to better capture patients’ experiences with mental disorders. Prior to its May 2013 release, the American Psychiatric Association (APA) conducted field trials to examine the feasibility, clinical utility, reliability, and where possible, the validity of proposed DSM-5 diagnostic criteria and dimensional measures. The methods and measures proposed for the DSM-5 field trials were pilot tested in adult and child/adolescent clinical samples, with the goal to identify and correct design and procedural problems with the proposed methods before resources were expended for the larger DSM-5 Field Trials. Results allowed for the refinement of the protocols, procedures, and measures, which facilitated recruitment, implementation, and completion of the DSM-5 Field Trials. These results highlight the benefits of pilot studies in planning large multisite studies. PMID:24615761

Development of a user-friendly delivery method for the fungus Metarhizium anisopliae to control the ectoparasitic mite Varroa destructor in honey bee, Apis mellifera, colonies.

PubMed

Kanga, Lambert H B; Adamczyk, John; Patt, Joseph; Gracia, Carlos; Cascino, John

2010-12-01

A user-friendly method to deliver Metarhizium spores to honey bee colonies for control of Varroa mites was developed and tested. Patty blend formulations protected the fungal spores at brood nest temperatures and served as an improved delivery system of the fungus to bee hives. Field trials conducted in 2006 in Texas using freshly harvested spores indicated that patty blend formulations of 10 g of conidia per hive (applied twice) significantly reduced the numbers of mites per adult bee, mites in sealed brood cells, and residual mites at the end of the 47-day experimental period. Colony development in terms of adult bee populations and brood production also improved. Field trials conducted in 2007 in Florida using less virulent spores produced mixed results. Patty blends of 10 g of conidia per hive (applied twice) were less successful in significantly reducing the number of mites per adult bee. However, hive survivorship and colony strength were improved, and the numbers of residual mites were significantly reduced at the end of the 42-day experimental period. The overall results from 2003 to 2008 field trials indicated that it was critical to have fungal spores with good germination, pathogenicity and virulence. We determined that fungal spores (1 × 10(10) viable spores per gram) with 98% germination and high pathogenicity (95% mite mortality at day 7) provided successful control of mite populations in established honey bee colonies at 10 g of conidia per hive (applied twice). Overall, microbial control of Varroa mite with M. anisopliae is feasible and could be a useful component of an integrated pest management program.

Heterotic patterns in rapeseed (Brassica napus L.): I. Crosses between spring and Chinese semi-winter lines.

PubMed

Qian, W; Sass, O; Meng, J; Li, M; Frauen, M; Jung, C

2007-06-01

Chinese semi-winter rapeseed is genetically diverse from Canadian and European spring rapeseed. This study was conducted to evaluate the potential of semi-winter rapeseed for spring rapeseed hybrid breeding, to assess the genetic effects involved, and to estimate the correlation of parental genetic distance (GD) with hybrid performance, heterosis, general combining ability (GCA) and specific combining ability (SCA) in crosses between spring and semi-winter rapeseed lines. Four spring male sterile lines from Germany and Canada as testers were crossed with 13 Chinese semi-winter rapeseed lines to develop 52 hybrids, which were evaluated together with their parents and commercial hybrids for seed yield and oil content in three sets of field trials with 8 environments in Canada and Europe. The Chinese parental lines were not adapted to local environmental conditions as demonstrated by poor seed yields per se. However, the hybrids between the Chinese parents and the adapted spring rapeseed lines exhibited high heterosis for seed yield. The average mid-parent heterosis was 15% and ca. 50% of the hybrids were superior to the respective hybrid control across three sets of field trials. Additive gene effects mainly contributed to hybrid performance since the mean squares of GCA were higher as compared to SCA. The correlation between parental GD and hybrid performance and heterosis was found to be low whereas the correlation between GCA((f + m)) and hybrid performance was high and significant in each set of field trials, with an average of r = 0.87 for seed yield and r = 0.89 for oil content, indicating that hybrid performance can be predicted by GCA((f + m)). These results demonstrate that Chinese semi-winter rapeseed germplasm has a great potential to increase seed yield in spring rapeseed hybrid breeding programs in Canada and Europe.

The effects of bilateral presentations on lateralized lexical decision.

PubMed

Fernandino, Leonardo; Iacoboni, Marco; Zaidel, Eran

2007-06-01

We investigated how lateralized lexical decision is affected by the presence of distractors in the visual hemifield contralateral to the target. The study had three goals: first, to determine how the presence of a distractor (either a word or a pseudoword) affects visual field differences in the processing of the target; second, to identify the stage of the process in which the distractor is affecting the decision about the target; and third, to determine whether the interaction between the lexicality of the target and the lexicality of the distractor ("lexical redundancy effect") is due to facilitation or inhibition of lexical processing. Unilateral and bilateral trials were presented in separate blocks. Target stimuli were always underlined. Regarding our first goal, we found that bilateral presentations (a) increased the effect of visual hemifield of presentation (right visual field advantage) for words by slowing down the processing of word targets presented to the left visual field, and (b) produced an interaction between visual hemifield of presentation (VF) and target lexicality (TLex), which implies the use of different strategies by the two hemispheres in lexical processing. For our second goal of determining the processing stage that is affected by the distractor, we introduced a third condition in which targets were always accompanied by "perceptual" distractors consisting of sequences of the letter "x" (e.g., xxxx). Performance on these trials indicated that most of the interaction occurs during lexical access (after basic perceptual analysis but before response programming). Finally, a comparison between performance patterns on the trials containing perceptual and lexical distractors indicated that the lexical redundancy effect is mainly due to inhibition of word processing by pseudoword distractors.

Effects of mindfulness on maternal stress, depressive symptoms and awareness of present moment experience: A pilot randomised trial.

PubMed

Beattie, Jill; Hall, Helen; Biro, Mary Anne; East, Christine; Lau, Rosalind

2017-07-01

To determine the feasibility and acceptability and measure the effects of a mindfulness intervention compared to a pregnancy support program on stress, depressive symptoms and awareness of present moment experience. A pilot randomised trial using mixed methods. Forty-eight women attending a maternity service were randomly allocated to a mindfulness-based or pregnancy support program. Perceived Stress Scale, Edinburgh Postnatal Depression Scale, Mindfulness Attention Awareness Scale, and Birth Outcomes. Women's perceptions of the impact of the programs were examined via summative evaluation, interviews, diaries and facilitator field notes. Nine women in the mindfulness program and 11 in the pregnancy support program completed post-program measures. There were no statistically significant differences between groups. Of practical significance, was an improvement in measures for both groups with a greater improvement in awareness of present moment experience for the intervention group. The intervention group reported learning how to manage stressors, fear, anxiety, and to regulate their attention to be more present. The control group reported learning how to calm down when stressed which increased their confidence. Intervention group themes were: releasing stress, becoming aware, accepting, having options and choices, connecting and being compassionate. Control group themes were:managing stress, increasing confidence, connecting, focussing, being accepted, preparing. The feasibility and acceptability of the intervention was confirmed. Programs decreased women's self-reported stress in different ways. Women in the mindfulness program accepted themselves and their experiences as they arose and passed in the present moment, while those in the control group gained acceptance primarily from external sources such as peers. Mindfulness programs can foster an internalised locus of self-acceptance which may result in woman becoming less dependent on others for their wellbeing. Adequately powered RCTs, with an active control, long-term follow up and economic evaluation are recommended. Copyright © 2017 Elsevier Ltd. All rights reserved.

Moving from rhetoric to reality: adapting Housing First for homeless individuals with mental illness from ethno-racial groups.

PubMed

Stergiopoulos, Vicky; O'Campo, Patricia; Gozdzik, Agnes; Jeyaratnam, Jeyagobi; Corneau, Simon; Sarang, Aseefa; Hwang, Stephen W

2012-10-02

The literature on interventions addressing the intersection of homelessness, mental illness and race is scant. The At Home/Chez Soi research demonstration project is a pragmatic field trial investigating a Housing First intervention for homeless individuals with mental illness in five cities across Canada. A unique focus at the Toronto site has been the development and implementation of a Housing First Ethno-Racial Intensive Case Management (HF ER-ICM) arm of the trial serving 100 homeless individuals with mental illness from ethno-racial groups. The HF ER-ICM program combines the Housing First approach with an anti-racism/anti-oppression framework of practice. This paper presents the findings of an early implementation and fidelity evaluation of the HF ER-ICM program, supplemented by participant narrative interviews to inform our understanding of the HF ER-ICM program theory. Descriptive statistics are used to describe HF ER-ICM participant characteristics. Focus group interviews, key informant interviews and fidelity assessments were conducted between November 2010 and January 2011, as part of the program implementation evaluation. In-depth qualitative interviews with HF ER-ICM participants and control group members were conducted between March 2010 and June 2011. All qualitative data were analysed using grounded theory methodology. The target population had complex health and social service needs. The HF ER-ICM program enjoyed a high degree of fidelity to principles of both anti-racism/anti-oppression practice and Housing First and comprehensively addressed the housing, health and sociocultural needs of participants. Program providers reported congruence of these philosophies of practice, and program participants valued the program and its components. Adapting Housing First with anti-racism/anti-oppression principles offers a promising approach to serving the diverse needs of homeless people from ethno-racial groups and strengthening the service systems developed to support them. The use of fidelity and implementation evaluations can be helpful in supporting successful adaptations of programs and services.

The Technical Report of NAEP's 1990 Trial State Assessment Program.

ERIC Educational Resources Information Center

Koffler, Stephen L.; And Others

This report documents the design and data analysis procedures of the Trial State Assessment Program of the National Assessment of Educational Progress (NAEP). Today the NAEP is the only survey using advanced plausible values methodology that uses a multiple imputation procedure in a psychometric context. The 1990 Trial State Assessment collected…

Teaching residents practice-management knowledge and skills: an in vivo experience.

PubMed

Williams, Laurel Lyn

2009-01-01

This article explores the relevant data regarding teaching psychiatric residents practice management knowledge and skills. This article also introduces a unique program for teaching practice management to residents. A literature search was conducted through PubMed and Academic Psychiatry. Additionally residents involved in the training program for practice management were given an anonymous survey to complete. There were no randomized, controlled trials in the academic psychiatric field concerning the topic of practice management. The responses to the resident survey (n=10) indicated a modest improvement in residents' perception of receiving adequate training and exposure to practice management knowledge and skills. The available research suggests that many residents and faculty believe that practice management knowledge and skills are still not adequately addressed. The Baylor Clinic practice management program may be one possible solution for integrating the teaching of practice management knowledge and skills. More research on this topic is needed.

Study protocol for the evaluation of an Infant Simulator based program delivered in schools: a pragmatic cluster randomised controlled trial

PubMed Central

2010-01-01

Background This paper presents the study protocol for a pragmatic randomised controlled trial to evaluate the impact of a school based program developed to prevent teenage pregnancy. The program includes students taking care of an Infant Simulator; despite growing popularity and an increasing global presence of such programs, there is no published evidence of their long-term impact. The aim of this trial is to evaluate the Virtual Infant Parenting (VIP) program by investigating pre-conceptual health and risk behaviours, teen pregnancy and the resultant birth outcomes, early child health and maternal health. Methods and Design Fifty-seven schools (86% of 66 eligible secondary schools) in Perth, Australia were recruited to the clustered (by school) randomised trial, with even randomisation to the intervention and control arms. Between 2003 and 2006, the VIP program was administered to 1,267 participants in the intervention schools, while 1,567 participants in the non-intervention schools received standard curriculum. Participants were all female and aged between 13-15 years upon recruitment. Pre and post-intervention questionnaires measured short-term impact and participants are now being followed through their teenage years via data linkage to hospital medical records, abortion clinics and education records. Participants who have a live birth are interviewed by face-to-face interview. Kaplan-Meier survival analysis and proportional hazards regression will test for differences in pregnancy, birth and abortion rates during the teenage years between the study arms. Discussion This protocol paper provides a detailed overview of the trial design as well as initial results in the form of participant flow. The authors describe the intervention and its delivery within the natural school setting and discuss the practical issues in the conduct of the trial, including recruitment. The trial is pragmatic and will directly inform those who provide Infant Simulator based programs in school settings. Trial registration ISRCTN24952438 PMID:20964860

Field design factors affecting the precision of ryegrass forage yield estimation

USDA-ARS?s Scientific Manuscript database

Field-based agronomic and genetic research relies heavily on the data generated from field evaluations. Therefore, it is imperative to optimize the precision and accuracy of yield estimates in cultivar evaluation trials to make reliable selections. Experimental error in yield trials is sensitive to ...

Hunner's Ulcers

MedlinePlus

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Bladder Retraining

MedlinePlus

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Men and IC

MedlinePlus

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IC Associated Conditions

MedlinePlus

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General IC Symptoms

MedlinePlus

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Children and IC

MedlinePlus

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Field Trial of Methoxyflurane, Nitrous Oxide, and Trichloroethylene as Obstetric Analgesics

PubMed Central

Rosen, M.; Mushin, W. W.; Jones, P. L.; Jones, E. V.

1969-01-01

In a field trial of 1,257 patients receiving methoxyflurane, trichloroethylene, and nitrous-oxide/oxygen for the relief of pain in labour methoxyflurane has been shown to have certain advantages which support its use in midwifery practice. The trial confirms our objective method for screening an inhalational agent as an obstetric analgesic. PMID:4895340

First field trials with fungi against Anoplophora glabripennis

Treesearch

Thomas Dubois; Ann Hajek; Hu Jiafu; Zengzhi Li

2003-01-01

We have been evaluating the use of entomopathogenic fungi against A. glabripennis; so far, 20 strains have been isolated belonging to three species, 14 strains have been tested in the laboratory, five strains have been evaluated in caged field trials and two strains have been tested in the open field.

Lost Hills Field Trial - incorporating new technology for resevoir management

NASA Technical Reports Server (NTRS)

Fielding, E. J.; Brink, J. L.; Patzek, T. W.; Silin, D. B.

2002-01-01

This paper will discuss how Chevron U.S.A. Production Company is implementing a field trial that will use Supervisory Control and Data Acquisition (SCADA)on injection wells, in conjunction with satellite images to measure ground elevation changes, to perform real-time resevoir management in the Lost Hills Field.

Interstitial Cystitis and Diet

MedlinePlus

... Epidemiology (RICE) Study Boston Area Community Health (BACH) Survey ICA Pilot Research Program Funding Opportunities Clinical Trial ... Epidemiology (RICE) Study Boston Area Community Health (BACH) Survey ICA Pilot Research Program Funding Opportunities Clinical Trial ...

IC Treatment: Surgical Procedures

MedlinePlus

... Epidemiology (RICE) Study Boston Area Community Health (BACH) Survey ICA Pilot Research Program Funding Opportunities Clinical Trial ... Epidemiology (RICE) Study Boston Area Community Health (BACH) Survey ICA Pilot Research Program Funding Opportunities Clinical Trial ...

IC: Frequently Asked Questions

MedlinePlus

... Epidemiology (RICE) Study Boston Area Community Health (BACH) Survey ICA Pilot Research Program Funding Opportunities Clinical Trial ... Epidemiology (RICE) Study Boston Area Community Health (BACH) Survey ICA Pilot Research Program Funding Opportunities Clinical Trial ...

Lab and Imaging Tests

MedlinePlus

... Grant Grant Finder Therapy Acceleration Program Academic Concierge Biotechnology Accelerator Clinical Trials Division Resources for HCPs Continuing ... Grant Grant Finder Therapy Acceleration Program Academic Concierge Biotechnology Accelerator Clinical Trials Division Resources for HCPs Continuing ...

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

PubMed

Bridgman, Kate; Onslow, Mark; O'Brian, Susan; Jones, Mark; Block, Susan

2016-10-01

Webcam treatment is potentially useful for health care in cases of early stuttering in which clients are isolated from specialized treatment services for geographic and other reasons. The purpose of the present trial was to compare outcomes of clinic and webcam deliveries of the Lidcombe Program treatment (Packman et al., 2015) for early stuttering. The design was a parallel, open plan, noninferiority randomized controlled trial of the standard Lidcombe Program treatment and the experimental webcam Lidcombe Program treatment. Participants were 49 children aged 3 years 0 months to 5 years 11 months at the start of treatment. Primary outcomes were the percentage of syllables stuttered at 9 months postrandomization and the number of consultations to complete Stage 1 of the Lidcombe Program. There was insufficient evidence of a posttreatment difference of the percentage of syllables stuttered between the standard and webcam Lidcombe Program treatments. There was insufficient evidence of a difference between the groups for typical stuttering severity measured by parents or the reported clinical relationship with the treating speech-language pathologist. This trial confirmed the viability of the webcam Lidcombe Program intervention. It appears to be as efficacious and economically viable as the standard, clinic Lidcombe Program treatment.

Patient engagement in clinical trials: The Clinical Trials Transformation Initiative's leadership from theory to practical implementation.

PubMed

Patrick-Lake, Bray

2018-02-01

Patient engagement is an increasingly important aspect of successful clinical trials. Over the past decade, as patient group involvement in clinical trials has continued to increase and diversify, the Clinical Trials Transformation Initiative has not only recognized the crucial role patients play in improving the clinical trial enterprise but also made a deep commitment to help grow and shape the emerging field of patient engagement. This article describes the evolution of patient engagement including the origins of the patient engagement movement; barriers to successful engagement and remaining challenges to full and valuable collaboration between patient groups and trial sponsors; and Clinical Trials Transformation Initiative's role in influencing the field through organizational practices, formal project work and resulting recommendations, and external advocacy efforts.

Dissonance and Healthy Weight Eating Disorder Prevention Programs: A Randomized Efficacy Trial

ERIC Educational Resources Information Center

Stice, Eric; Shaw, Heather; Burton, Emily; Wade, Emily

2006-01-01

In this trial, adolescent girls with body dissatisfaction (N = 481, M age = 17 years) were randomized to an eating disorder prevention program involving dissonance-inducing activities that reduce thin-ideal internalization, a prevention program promoting healthy weight management, an expressive writing control condition, or an assessment-only…

Multi-optical mine detection: results from a field trial

NASA Astrophysics Data System (ADS)

Letalick, Dietmar; Tolt, Gustav; Sjökvist, Stefan K.; Nyberg, Sten; Grönwall, Christina; Andersson, Pierre; Linderhed, Anna; Forssell, Göran; Larsson, Håkan; Uppsäll, Magnus

2006-05-01

As a part of the Swedish mine detection project MOMS, an initial field trial was conducted at the Swedish EOD and Demining Centre (SWEDEC). The purpose was to collect data on surface-laid mines, UXO, submunitions, IED's, and background with a variety of optical sensors, for further use in the project. Three terrain types were covered: forest, gravel road, and an area which had recovered after total removal of all vegetation some years before. The sensors used in the field trial included UV, VIS, and NIR sensors as well as thermal, multi-spectral, and hyper-spectral sensors, 3-D laser radar and polarization sensors. Some of the sensors were mounted on an aerial work platform, while others were placed on tripods on the ground. This paper describes the field trial and the presents some initial results obtained from the subsequent analysis.

Effectiveness trial of a selective dissonance-based eating disorder prevention program with female college students: Effects at 2- and 3-year follow-up.

PubMed

Stice, Eric; Rohde, Paul; Butryn, Meghan L; Shaw, Heather; Marti, C Nathan

2015-08-01

An efficacy trial found that a dissonance-based prevention program reduced risk factors, eating disorder symptoms, and future eating disorder onset, but smaller effects emerged when high school clinicians recruited students and delivered the program under real-world conditions in an effectiveness trial. The current report describes results at 2- and 3-year follow-up from an effectiveness trial that tested whether a new enhanced dissonance version of this program produced larger effects when college clinicians recruit students and deliver the intervention using improved train and supervision procedures. Young women from eight universities (N = 408, M age = 21.6, SD = 5.64) were randomized to the prevention program or an educational brochure control condition. Dissonance participants showed greater decreases in risk factors, eating disorder symptoms, and psychosocial impairment by 3-year follow-up than controls, but not healthcare utilization, BMI, or eating disorder onset. This novel multisite effectiveness trial found that the enhanced dissonance intervention and improved training and supervision procedures produced an average effect size at 3-year follow-up that was 290% and 160% larger than effects observed in the high school effectiveness trial and efficacy trial respectively. Yet, the lack of eating disorder onset effects may imply that factors beyond pursuit of the thin ideal now contribute to eating disorder onset. Copyright © 2015 Elsevier Ltd. All rights reserved.

Credentialing of radiotherapy centres in Australasia for TROG 09.02 (Chisel), a Phase III clinical trial on stereotactic ablative body radiotherapy of early stage lung cancer.

PubMed

Kron, Tomas; Chesson, Brent; Hardcastle, Nicholas; Crain, Melissa; Clements, Natalie; Burns, Mark; Ball, David

2018-05-01

A randomised clinical trial comparing stereotactic ablative body radiotherapy (SABR) with conventional radiotherapy for early stage lung cancer has been conducted in Australia and New Zealand under the auspices of the TransTasman Radiation Oncology Group (NCT01014130). We report on the technical credentialing program as prerequisite for centres joining the trial. Participating centres were asked to develop treatment plans for two test cases to assess their ability to create plans according to protocol. Dose delivery in the presence of inhomogeneity and motion was assessed during a site visit using a phantom with moving inserts. Site visits for the trial were conducted in 16 Australian and 3 New Zealand radiotherapy facilities. The tests with low density inhomogeneities confirmed shortcomings of the AAA algorithm for dose calculation. Dose was assessed for a typical treatment delivery including at least one non-coplanar beam in a stationary and moving phantom. This end-to-end test confirmed that all participating centres were able to deliver stereotactic ablative body radiotherapy with the required accuracy while the planning study demonstrated that they were able to produce acceptable plans for both test cases. The credentialing process documented that participating centres were able to deliver dose as required in the trial protocol. It also gave an opportunity to provide education about the trial and discuss technical issues such as four-dimensional CT, small field dosimetry and patient immobilisation with staff in participating centres. Advances in knowledge: Credentialing is an important quality assurance tool for radiotherapy trials using advanced technology. In addition to confirming technical competence, it provides an opportunity for education and discussion about the trial.

42 CFR 460.192 - Ongoing monitoring after trial period.

Code of Federal Regulations, 2011 CFR

2011-10-01

... SERVICES (CONTINUED) PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE) PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE) Federal/State Monitoring § 460.192 Ongoing monitoring after trial period. (a...

The Effect of India's Total Sanitation Campaign on Defecation Behaviors and Child Health in Rural Madhya Pradesh: A Cluster Randomized Controlled Trial

PubMed Central

Patil, Sumeet R.; Arnold, Benjamin F.; Salvatore, Alicia L.; Briceno, Bertha; Ganguly, Sandipan; Colford, John M.; Gertler, Paul J.

2014-01-01

Background Poor sanitation is thought to be a major cause of enteric infections among young children. However, there are no previously published randomized trials to measure the health impacts of large-scale sanitation programs. India's Total Sanitation Campaign (TSC) is one such program that seeks to end the practice of open defecation by changing social norms and behaviors, and providing technical support and financial subsidies. The objective of this study was to measure the effect of the TSC implemented with capacity building support from the World Bank's Water and Sanitation Program in Madhya Pradesh on availability of individual household latrines (IHLs), defecation behaviors, and child health (diarrhea, highly credible gastrointestinal illness [HCGI], parasitic infections, anemia, growth). Methods and Findings We conducted a cluster-randomized, controlled trial in 80 rural villages. Field staff collected baseline measures of sanitation conditions, behaviors, and child health (May–July 2009), and revisited households 21 months later (February–April 2011) after the program was delivered. The study enrolled a random sample of 5,209 children <5 years old from 3,039 households that had at least one child <24 months at the beginning of the study. A random subsample of 1,150 children <24 months at enrollment were tested for soil transmitted helminth and protozoan infections in stool. The randomization successfully balanced intervention and control groups, and we estimated differences between groups in an intention to treat analysis. The intervention increased percentage of households in a village with improved sanitation facilities as defined by the WHO/UNICEF Joint Monitoring Programme by an average of 19% (95% CI for difference: 12%–26%; group means: 22% control versus 41% intervention), decreased open defecation among adults by an average of 10% (95% CI for difference: 4%–15%; group means: 73% intervention versus 84% control). However, the intervention did not improve child health measured in terms of multiple health outcomes (diarrhea, HCGI, helminth infections, anemia, growth). Limitations of the study included a relatively short follow-up period following implementation, evidence for contamination in ten of the 40 control villages, and bias possible in self-reported outcomes for diarrhea, HCGI, and open defecation behaviors. Conclusions The intervention led to modest increases in availability of IHLs and even more modest reductions in open defecation. These improvements were insufficient to improve child health outcomes (diarrhea, HCGI, parasite infection, anemia, growth). The results underscore the difficulty of achieving adequately large improvements in sanitation levels to deliver expected health benefits within large-scale rural sanitation programs. Trial Registration ClinicalTrials.gov NCT01465204 Please see later in the article for the Editors' Summary PMID:25157929

The process of developing and implementing a telephone-based peer support program for postpartum depression: evidence from two randomized controlled trials

PubMed Central

2014-01-01

Background A randomized controlled trial evaluated the effect of telephone-based peer support on preventing postpartum depression (PPD) among high-risk mothers. The results indicated that support provided by peer volunteers may be an effective preventative strategy. The purpose of this paper is to outline the process of developing, implementing, maintaining, and evaluating the peer support program that we used in this PPD prevention trial. Methods The peer support program had been used successfully in a pilot trial and a previous breastfeeding peer support trial. Based on our experience and lessons learned, we developed a 4-phase, 12-step approach so that the peer support model could be copied and used by different health providers in various settings. We will use the PPD prevention trial to demonstrate the suggested steps. Results The trial aim to prevent the onset of PPD was established. Peer volunteers who previously experienced and recovered from self-reported PPD were recruited and attended a four-hour training session. Volunteers were screened and those identified as appropriate to provide support to postpartum mothers were selected. Women who scored more than 9 on the Edinburgh Postnatal Depression Scale within the first two weeks after childbirth were recruited to participate in the trial and proactive, individualized, telephone-based peer support (mother-to-mother) was provided to those randomized to the intervention group. Peer volunteers maintained the intervention, supported other volunteers, and evaluated the telephone-based support program. Possible negative effects of the intervention were assessed. An in-depth assessment of maternal perspectives of the program at 12 weeks postpartum was performed. Conclusions The 4-phase, 12-step approach delineated in this paper provides clear and concise guidelines for health professionals to follow in creating and implementing community-based, peer-support interventions with the potential to prevent PPD. Trial registration Current Controlled Trials ISRCTN68337727. PMID:24742217

Differentially Variable Component Analysis (dVCA): Identifying Multiple Evoked Components using Trial-to-Trial Variability

NASA Technical Reports Server (NTRS)

Knuth, Kevin H.; Shah, Ankoor S.; Truccolo, Wilson; Ding, Ming-Zhou; Bressler, Steven L.; Schroeder, Charles E.

2003-01-01

Electric potentials and magnetic fields generated by ensembles of synchronously active neurons in response to external stimuli provide information essential to understanding the processes underlying cognitive and sensorimotor activity. Interpreting recordings of these potentials and fields is difficult as each detector records signals simultaneously generated by various regions throughout the brain. We introduce the differentially Variable Component Analysis (dVCA) algorithm, which relies on trial-to-trial variability in response amplitude and latency to identify multiple components. Using simulations we evaluate the importance of response variability to component identification, the robustness of dVCA to noise, and its ability to characterize single-trial data. Finally, we evaluate the technique using visually evoked field potentials recorded at incremental depths across the layers of cortical area VI, in an awake, behaving macaque monkey.

Adding yeasts with sugar to increase the number of effective insecticide classes to manage Drosophila suzukii (Matsumura) (Diptera: Drosophilidae) in cherry.

PubMed

Knight, Alan L; Basoalto, Esteban; Yee, Wee; Hilton, Rick; Kurtzman, Cletus P

2016-08-01

Drosophila suzukii is a major pest of cherry in the western United States. We evaluated whether the addition of sugary baits could improve the efficacy of two classes of insecticides not considered to be sufficiently effective for this pest, diamides and spinosyns, in laboratory and field trials in cherry. Adding cane sugar alone or in combination with the yeasts Saccharomyces cerevisiae or Aureobasidium pullulans significantly improved insecticide efficacy. However, the significance of adding yeasts to the sugar plus insecticide on fly mortality varied with respect to both the insecticide and yeast species. The addition of S. cerevisiae to sugar also did not significantly reduce egg densities in fruit compared with sugar alone. The addition of a yeast plus sugar significantly reduced egg densities in three field trials with cyantraniliprole and in two out of three trials with spinosad. The addition of cane sugar with or without yeast can improve the effectiveness of diamide and spinosyn insecticides for D. suzukii in cherry. Inclusion of these two insecticides in D. suzukii management programs may alleviate the strong selection pressure currently being imposed on a few mode-of-action insecticide classes used by growers to maintain fly suppression over long continuous harvest periods of mixed cultivars. Published 2015. This article is a U.S. Government work and is in the public domain in the USA. Published 2015. This article is a U.S. Government work and is in the public domain in the USA.

Efficacy of an Exercise and Nutritional Supplement Program on Physical Performance and Nutritional Status in Older Adults With Mobility Limitations Residing at Senior Living Facilities.

PubMed

Corcoran, Michael P; Nelson, Miriam E; Sacheck, Jennifer M; Reid, Kieran F; Kirn, Dylan; Fielding, Roger A; Chui, Kenneth K H; Folta, Sara C

2017-07-01

This cluster-randomized trial was designed to determine the efficacy of a 6-month exercise-nutritional supplement program (ENP) on physical function and nutritional status for older adults and the feasibility of implementing this program in a senior living setting. Twenty senior-living facilities were randomized to either a 3 day per week group-based ENP led by a trained facility staff member or a health education program (SAP). Participants (N = 121) completed a short physical performance battery, 400-m walk, handgrip strength test, and mini-nutrition assessment. 25-hydroxyvitamin D [25(OH)D], insulin-like growth-factor 1 (IGF-1), and activity level were also measured. The ENP did not significantly improve physical function or nutritional status compared with the SAP. Compared with baseline, participants in the ENP engaged in 39 min less physical activity per week at 6 months. Several facility characteristics hindered implementation of the ENP. This study highlights the complexity of implementing an evidence-based program in a field setting.

Adapting a Program to Inform African American and Hispanic American Women About Cancer Clinical Trials

PubMed Central

Gonzalez, Jenny; Mumman, Manpreet; Cullen, Lisa; LaHousse, Sheila F.; Malcarne, Vanessa; Conde, Viridiana; Riley, Natasha

2010-01-01

The dearth of evidence-based clinical trial education programs may contribute to the underrepresentation of African American and Hispanic American women in cancer research studies. This study used focus group-derived data from 80 women distributed among eight Spanish- and English-language focus groups. These data guided the researchers’ adaptation and refinement of the National Cancer Institute’s various clinical trials education programs into a program that was specifically focused on meeting the information needs of minority women and addressing the barriers to study participation that they perceived. A “sisterhood” theme was adopted and woven throughout the presentation. PMID:20146043

Using School-Level Interviews to Develop a Multisite PE Intervention Program

PubMed Central

Moe, Stacey G.; Pickrel, Julie; McKenzie, Thomas L.; Strikmiller, Patricia K.; Coombs, Derek; Murrie, Dale

2008-01-01

The Trial of Activity for Adolescent Girls (TAAG) is a randomized, multicenter field trial in middle schools that aims to reduce the decline of physical activity in adolescent girls. To inform the development of the TAAG intervention, two phases of formative research are conducted to gain information on school structure and environment and on the conduct of physical education classes. Principals and designated staff at 64 eligible middle schools were interviewed using the School Survey during Phase 1. The following year (Phase 2), physical education department heads of the 36 schools selected into TAAG were interviewed. Responses were examined to design a standardized, multicomponent physical activity intervention for six regions of the United States. This article describes the contribution of formative research to the development of the physical education intervention component and summarizes the alignment of current school policies and practices with national and state standards. PMID:16397159

Assessing Clinical Trial–Associated Workload in Community-Based Research Programs Using the ASCO Clinical Trial Workload Assessment Tool

PubMed Central

Hurley, Patricia; Woo, Kaitlin M.; Szczepanek, Connie; Stewart, Teresa; Robert, Nicholas; Lyss, Alan; Gönen, Mithat; Lilenbaum, Rogerio

2016-01-01

Purpose: Clinical research program managers are regularly faced with the quandary of determining how much of a workload research staff members can manage while they balance clinical practice and still achieve clinical trial accrual goals, maintain data quality and protocol compliance, and stay within budget. A tool was developed to measure clinical trial–associated workload, to apply objective metrics toward documentation of work, and to provide clearer insight to better meet clinical research program challenges and aid in balancing staff workloads. A project was conducted to assess the feasibility and utility of using this tool in diverse research settings. Methods: Community-based research programs were recruited to collect and enter clinical trial–associated monthly workload data into a web-based tool for 6 consecutive months. Descriptive statistics were computed for self-reported program characteristics and workload data, including staff acuity scores and number of patient encounters. Results: Fifty-one research programs that represented 30 states participated. Median staff acuity scores were highest for staff with patients enrolled in studies and receiving treatment, relative to staff with patients in follow-up status. Treatment trials typically resulted in higher median staff acuity, relative to cancer control, observational/registry, and prevention trials. Industry trials exhibited higher median staff acuity scores than trials sponsored by the National Institutes of Health/National Cancer Institute, academic institutions, or others. Conclusion: The results from this project demonstrate that trial-specific acuity measurement is a better measure of workload than simply counting the number of patients. The tool was shown to be feasible and useable in diverse community-based research settings. PMID:27006354

Clinical Trial Assessment of Infrastructure Matrix Tool to Improve the Quality of Research Conduct in the Community.

PubMed

Dimond, Eileen P; Zon, Robin T; Weiner, Bryan J; St Germain, Diane; Denicoff, Andrea M; Dempsey, Kandie; Carrigan, Angela C; Teal, Randall W; Good, Marjorie J; McCaskill-Stevens, Worta; Grubbs, Stephen S; Dimond, Eileen P; Zon, Robin T; Weiner, Bryan J; St Germain, Diane; Denicoff, Andrea M; Dempsey, Kandie; Carrigan, Angela C; Teal, Randall W; Good, Marjorie J; McCaskill-Stevens, Worta; Grubbs, Stephen S

2016-01-01

Several publications have described minimum standards and exemplary attributes for clinical trial sites to improve research quality. The National Cancer Institute (NCI) Community Cancer Centers Program (NCCCP) developed the clinical trial Best Practice Matrix tool to facilitate research program improvements through annual self-assessments and benchmarking. The tool identified nine attributes, each with three progressive levels, to score clinical trial infrastructural elements from less to more exemplary. The NCCCP sites correlated tool use with research program improvements, and the NCI pursued a formative evaluation to refine the interpretability and measurability of the tool. From 2011 to 2013, 21 NCCCP sites self-assessed their programs with the tool annually. During 2013 to 2014, NCI collaborators conducted a five-step formative evaluation of the matrix tool. Sites reported significant increases in level-three scores across the original nine attributes combined (P<.001). Two specific attributes exhibited significant change: clinical trial portfolio diversity and management (P=.0228) and clinical trial communication (P=.0281). The formative evaluation led to revisions, including renaming the Best Practice Matrix as the Clinical Trial Assessment of Infrastructure Matrix (CT AIM), expanding infrastructural attributes from nine to 11, clarifying metrics, and developing a new scoring tool. Broad community input, cognitive interviews, and pilot testing improved the usability and functionality of the tool. Research programs are encouraged to use the CT AIM to assess and improve site infrastructure. Experience within the NCCCP suggests that the CT AIM is useful for improving quality, benchmarking research performance, reporting progress, and communicating program needs with institutional leaders. The tool model may also be useful in disciplines beyond oncology.

Evaluating the Effectiveness of Two Commonly Used Discrete Trial Procedures for Teaching Receptive Discrimination to Young Children with Autism Spectrum Disorders

ERIC Educational Resources Information Center

Gutierrez, Anibal, Jr.; Hale, Melissa N.; O'Brien, Heather A.; Fischer, Aaron J.; Durocher, Jennifer S.; Alessandri, Michael

2009-01-01

Discrete trial teaching procedures have been demonstrated to be effective in teaching a variety of important skills for children with autism spectrum disorders (ASD). Although all discrete trial programs are based in the principles of applied behavior analysis, some variability exists between programs with regards to the precise teaching…

An Effectiveness Trial of a Selected Dissonance-Based Eating Disorder Prevention Program for Female High School Students: Long-Term Effects

ERIC Educational Resources Information Center

Stice, Eric; Rohde, Paul; Shaw, Heather; Gau, Jeff

2011-01-01

Objective: Efficacy trials found that a dissonance-based eating disorder prevention program in which female high school and college students with body image concerns critique the thin ideal reduced eating disorder risk factors, eating disorder symptoms, and future eating disorder onset. The present effectiveness trial tested whether this program…

Estimates of Intraclass Correlation Coefficients from Longitudinal Group-Randomized Trials of Adolescent HIV/STI/Pregnancy Prevention Programs

ERIC Educational Resources Information Center

Glassman, Jill R.; Potter, Susan C.; Baumler, Elizabeth R.; Coyle, Karin K.

2015-01-01

Introduction: Group-randomized trials (GRTs) are one of the most rigorous methods for evaluating the effectiveness of group-based health risk prevention programs. Efficiently designing GRTs with a sample size that is sufficient for meeting the trial's power and precision goals while not wasting resources exceeding them requires estimates of the…

Predicting Performance in Higher Education Using Proximal Predictors.

PubMed

Niessen, A Susan M; Meijer, Rob R; Tendeiro, Jorge N

2016-01-01

We studied the validity of two methods for predicting academic performance and student-program fit that were proximal to important study criteria. Applicants to an undergraduate psychology program participated in a selection procedure containing a trial-studying test based on a work sample approach, and specific skills tests in English and math. Test scores were used to predict academic achievement and progress after the first year, achievement in specific course types, enrollment, and dropout after the first year. All tests showed positive significant correlations with the criteria. The trial-studying test was consistently the best predictor in the admission procedure. We found no significant differences between the predictive validity of the trial-studying test and prior educational performance, and substantial shared explained variance between the two predictors. Only applicants with lower trial-studying scores were significantly less likely to enroll in the program. In conclusion, the trial-studying test yielded predictive validities similar to that of prior educational performance and possibly enabled self-selection. In admissions aimed at student-program fit, or in admissions in which past educational performance is difficult to use, a trial-studying test is a good instrument to predict academic performance.

Field trials of line transect methods applied to estimation of desert tortoise abundance

USGS Publications Warehouse

Anderson, David R.; Burnham, Kenneth P.; Lubow, Bruce C.; Thomas, L. E. N.; Corn, Paul Stephen; Medica, Philip A.; Marlow, R.W.

2001-01-01

We examine the degree to which field observers can meet the assumptions underlying line transect sampling to monitor populations of desert tortoises (Gopherus agassizii). We present the results of 2 field trials using artificial tortoise models in 3 size classes. The trials were conducted on 2 occasions on an area south of Las Vegas, Nevada, where the density of the test population was known. In the first trials, conducted largely by experienced biologists who had been involved in tortoise surveys for many years, the density of adult tortoise models was well estimated (-3.9% bias), while the bias was higher (-20%) for subadult tortoise models. The bias for combined data was -12.0%. The bias was largely attributed to the failure to detect all tortoise models on or near the transect centerline. The second trials were conducted with a group of largely inexperienced student volunteers and used somewhat different searching methods, and the results were similar to the first trials. Estimated combined density of subadult and adult tortoise models had a negative bias (-7.3%), again attributable to failure to detect some models on or near the centerline. Experience in desert tortoise biology, either comparing the first and second trials or in the second trial with 2 experienced biologists versus 16 novices, did not have an apparent effect on the quality of the data or the accuracy of the estimates. Observer training, specific to line transect sampling, and field testing are important components of a reliable survey. Line transect sampling represents a viable method for large-scale monitoring of populations of desert tortoise; however, field protocol must be improved to assure the key assumptions are met.

Learning about and from a Distribution of Program Impacts Using Multisite Trials

ERIC Educational Resources Information Center

Raudenbush, Stephen W.; Bloom, Howard S.

2015-01-01

The present article provides a synthesis of the conceptual and statistical issues involved in using multisite randomized trials to learn about and from a distribution of heterogeneous program impacts across individuals and/or program sites. Learning "about" such a distribution involves estimating its mean value, detecting and quantifying…

78 FR 21130 - Submission for OMB Review; 30-day Comment Request: The Clinical Trials Reporting Program (CTRP...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-day Comment Request: The Clinical Trials Reporting Program (CTRP) Database (NCI) SUMMARY: Under... Program (CTRP) Database, 0925-0600, Expiration Date 3/31/2013--REINSTATEMENT WITH CHANGE, National Cancer...

Evaluation of Parent and Child Enhancement (PACE) Program: Randomized Controlled Trial

ERIC Educational Resources Information Center

Leung, Cynthia; Tsang, Sandra; Lo, Cyrus

2017-01-01

Objective: This study examined the efficacy of the Parent and Child Enhancement (PACE) program on child learning, child behavior problems, and parental stress, using randomized controlled trial design, in social services centers. Methods: Eligibility criteria were (1) children aged 2 years at program commencement, (2) low-income, new immigrant, or…

Effectiveness of a Parent Training Program in (Pre)Adolescence: Evidence from a Randomized Controlled Trial

ERIC Educational Resources Information Center

Leijten, Patty; Overbeek, Geertjan; Janssens, Jan M. A. M.

2012-01-01

The present randomized controlled trial examined the effectiveness of the parent training program Parents and Children Talking Together (PCTT) for parents with children in the preadolescent period who experience parenting difficulties. The program is focused on reducing child problem behavior by improving parents' communication and problem solving…

Oak restoration trials: Santa Catalina Island

Treesearch

Lisa Stratton

2002-01-01

Two restoration trials involving four oak species have been implemented as part of a larger restoration program for Catalina Island. In 1997 the Catalina Island Conservancy began an active program of restoration after 50 years of ranching and farming activities on the island. The restoration program includes removing feral goats and pigs island-wide and converting 80...

School-Based Violence Prevention Programs: Systematic Review of Secondary Prevention Trials.

ERIC Educational Resources Information Center

Mytton, Julie A.; DiGuiseppi, Carolyn; Gough, David A.; Taylor, Rod S.; Logan, Stuart

2002-01-01

Conducted a systematic review and meta-analysis of randomized controlled secondary prevention trials to explore the effects of school-based violence prevention programs on aggressive and violent behavior in children at high risk for violence. Results indicated that such programs produced modest reductions in aggressive and violent behaviors in…

Programming of left hand exploits task set but that of right hand depends on recent history.

PubMed

Tang, Rixin; Zhu, Hong

2017-07-01

There are many differences between the left hand and the right hand. But it is not clear if there is a difference in programming between left hand and right hand when the hands perform the same movement. In current study, we carried out two experiments to investigate whether the programming of two hands was equivalent or they exploited different strategies. In the first experiment, participants were required to use one hand to grasp an object with visual feedback or to point to the center of one object without visual feedback on alternate trials, or to grasp an object without visual feedback and to point the center of one object with visual feedback on alternating trials. They then performed the tasks with the other hand. The result was that previous pointing task affected current grasping when it was performed by the left hand, but not the right hand. In experiment 2, we studied if the programming of the left (or right) hand would be affected by the pointing task performed on the previous trial not only by the same hand, but also by the right (or left) hand. Participants pointed and grasped the objects alternately with two hands. The result was similar with Experiment 1, i.e., left-hand grasping was affected by right-hand pointing, whereas right-hand grasping was immune from the interference from left hand. Taken together, the results suggest that when open- and closed-loop trials are interleaved, motor programming of grasping with the right hand was affected by the nature of the online feedback on the previous trial only if it was a grasping trial, suggesting that the trial-to-trial transfer depends on sensorimotor memory and not on task set. In contrast, motor programming of grasping with the left hand can use information about the nature of the online feedback on the previous trial to specify the parameters of the movement, even when the type of movement that occurred was quite different (i.e., pointing) and was performed with the right hand. This suggests that trial-to-trial transfer with the left hand depends on some sort of carry-over of task set for dealing with the availability of visual feedback.

Use of an atrial lead with very short tip-to-ring spacing avoids oversensing of far-field R-wave.

PubMed

Kolb, Christof; Nölker, Georg; Lennerz, Carsten; Jetter, Hansmartin; Semmler, Verena; Pürner, Klaus; Gutleben, Klaus-Jürgen; Reents, Tilko; Lang, Klaus; Lotze, Ulrich

2012-01-01

The AVOID-FFS (Avoidance of Far-Field R-wave Sensing) study aimed to investigate whether an atrial lead with a very short tip-to-ring spacing without optimization of pacemaker settings shows equally low incidence of far-field R-wave sensing (FFS) when compared to a conventional atrial lead in combination with optimization of the programming. Patients receiving a dual chamber pacemaker were randomly assigned to receive an atrial lead with a tip-to-ring spacing of 1.1 mm or a lead with a conventional tip-to-ring spacing of 10 mm. Postventricular atrial blanking (PVAB) was programmed to the shortest possible value of 60 ms in the study group, and to an individually determined optimized value in the control group. Atrial sensing threshold was programmed to 0.3 mV in both groups. False positive mode switch caused by FFS was evaluated at one and three months post implantation. A total of 204 patients (121 male; age 73±10 years) were included in the study. False positive mode switch caused by FFS was detected in one (1%) patient of the study group and two (2%) patients of the control group (p = 0.62). The use of an atrial electrode with a very short tip-to-ring spacing avoids inappropriate mode switch caused by FFS without the need for individual PVAB optimization. ClinicalTrials.gov NCT00512915.

Specific Cell (Re-)Programming: Approaches and Perspectives.

PubMed

Hausburg, Frauke; Jung, Julia Jeannine; David, Robert

2018-01-01

Many disorders are manifested by dysfunction of key cell types or their disturbed integration in complex organs. Thereby, adult organ systems often bear restricted self-renewal potential and are incapable of achieving functional regeneration. This underlies the need for novel strategies in the field of cell (re-)programming-based regenerative medicine as well as for drug development in vitro. The regenerative field has been hampered by restricted availability of adult stem cells and the potentially hazardous features of pluripotent embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs). Moreover, ethical concerns and legal restrictions regarding the generation and use of ESCs still exist. The establishment of direct reprogramming protocols for various therapeutically valuable somatic cell types has overcome some of these limitations. Meanwhile, new perspectives for safe and efficient generation of different specified somatic cell types have emerged from numerous approaches relying on exogenous expression of lineage-specific transcription factors, coding and noncoding RNAs, and chemical compounds.It should be of highest priority to develop protocols for the production of mature and physiologically functional cells with properties ideally matching those of their endogenous counterparts. Their availability can bring together basic research, drug screening, safety testing, and ultimately clinical trials. Here, we highlight the remarkable successes in cellular (re-)programming, which have greatly advanced the field of regenerative medicine in recent years. In particular, we review recent progress on the generation of cardiomyocyte subtypes, with a focus on cardiac pacemaker cells. Graphical Abstract.

An Effectiveness Trial of a New Enhanced Dissonance Eating Disorder Prevention Program among Female College Students

PubMed Central

Stice, Eric; Butryn, Meghan L.; Rohde, Paul; Shaw, Heather; Marti, C. Nathan

2014-01-01

Objective Efficacy trials indicate that a dissonance-based prevention program in which female high school and college students with body image concerns critique the thin-ideal reduced risk factors, eating disorder symptoms, and future eating disorder onset, but weaker effects emerged from an effectiveness trial wherein high school clinicians recruited students and delivered the program under real-world conditions. The present effectiveness trial tested whether a new enhanced dissonance version of this program produced larger effects when college clinicians recruited students and delivered the intervention using improved procedures to select, train, and supervise clinicians. Method Young women recruited from seven universities across the US (N = 408, M age = 21.6, SD = 5.64) were randomized to the dissonance intervention or an educational brochure control condition. Results Dissonance participants showed significantly greater decreases in risk factors (thin-ideal internalization, body dissatisfaction, dieting, negative affect) and eating disorder symptoms versus controls at posttest and 1-year follow-up, resulting in medium average effect size (d = .60). Dissonance participants also reported significant improvements in psychosocial functioning, but not reduced healthcare utilization or unhealthy weight gain. Conclusions This novel multisite effectiveness trial with college clinicians found that the enhanced dissonance version of this program and the improved facilitator selection/training procedures produced average effects that were 83% larger than effects observed in the high school effectiveness trial. PMID:24189570

Soil stabilization field trial : interim report II.

DOT National Transportation Integrated Search

2002-02-01

Shrinkage cracks in cement-stabilized bases/subbase can be alleviated by specifying the right cement dosage, or by other additives/procedures that suppress crack susceptibility. A field trial of six 1000 ft sections to investigate several alternative...

Soil stabilization field trial : interim report.

DOT National Transportation Integrated Search

2001-04-01

Shrinkage cracks in cement-stabilized bases/subbase can be alleviated by specifying : the right cement dosage, or by other additives/procedures that suppress crack susceptibility. A field : trial of six 1000 ft test sections to investigate several al...

Field trial of solvent-free emulsion in Oregon : appendices.

DOT National Transportation Integrated Search

2003-03-01

This final report summarizes construction, laboratory and performance information gathered by ODOT personnel from a single field trial of solvent-free emulsion mix constructed in June 2001. The solvent-free emulsion mix presented several placement pr...

Soil stabilization field trial : interim report I.

DOT National Transportation Integrated Search

2001-04-01

Shrinkage cracks in cement-stabilized bases/subbase can be alleviated by specifying the right cement dosage, or by other additives/procedures that suppress crack susceptibility. A field trial of six 1000 ft test sections to investigate several altern...

Soil stabilization field trial : interim report III.

DOT National Transportation Integrated Search

2003-11-01

Shrinkage cracks in cement-stabilized bases/subbase can be alleviated by specifying the right cement dosage, or by other additives/procedures that suppress crack susceptibility. A field trial of six 1000 ft test sections to investigate several altern...

Impact of online education on intern behaviour around Joint Commission National Patient Safety Goals: A randomised trial

PubMed Central

TJ, Shaw; LIM, Pernar; SE, Peyre; JF, Helfrick; K, Vogelgesang; E, Graydon-Baker; Y, Chretien; EJ, Brown; J, Nicholson; JJ, Heit; JP, Co; TK, Gandhi

2014-01-01

Purpose To compare the effectiveness of 2 types of online learning methodologies for improving the patient-safety behaviours mandated in the Joint Commission National Patient Safety Goals (NPSG). Methods This randomized controlled trial was conducted in 2010 at Massachusetts General Hospital (MGH) and Brigham & Women’s Hospital (BWH) in Boston USA. Incoming interns were randomised to either receive an online Spaced Education program (SE) consisting of cases and questions that reinforce over time, or a program consisting of an online slide show followed by a quiz (SQ). The outcome measures included NPSG-knowledge improvement, NPSG-compliant behaviors in a simulation scenario, self reported confidence in safety and quality, program acceptability and program relevance. Results Both online learning programs improved knowledge retention. On four out of seven survey items measuring satisfaction and self reported confidence, the proportion of SE interns responding positively was significantly higher (p<0.05) than the fraction of SQ interns. SE interns demonstrated a mean 4.79 (36.6%) NPSG-compliant behaviors (out of 13 total), while SQ interns completed a mean 4.17 (32.0%) (p=0.09). Among those in surgical fields, SE interns demonstrated a mean 5.67 (43.6%) NPSG-compliant behaviors, while SQ interns completed a mean 2.33 (17.9%) (p=0.015). Focus group data indicates that SE was more contextually relevant than SQ and significantly more engaging. Conclusion While both online methodologies improved knowledge surrounding the NPSG, SE was more contextually relevant to trainees and engaging. SE impacted more significantly on both self reported confidence and the behaviour of surgical residents in a simulated scenario. PMID:22706930

Study protocol for the evaluation of an Infant Simulator based program delivered in schools: a pragmatic cluster randomised controlled trial.

PubMed

Brinkman, Sally A; Johnson, Sarah E; Lawrence, David; Codde, James P; Hart, Michael B; Straton, Judith A Y; Silburn, Sven

2010-10-21

This paper presents the study protocol for a pragmatic randomised controlled trial to evaluate the impact of a school based program developed to prevent teenage pregnancy. The program includes students taking care of an Infant Simulator; despite growing popularity and an increasing global presence of such programs, there is no published evidence of their long-term impact. The aim of this trial is to evaluate the Virtual Infant Parenting (VIP) program by investigating pre-conceptual health and risk behaviours, teen pregnancy and the resultant birth outcomes, early child health and maternal health. Fifty-seven schools (86% of 66 eligible secondary schools) in Perth, Australia were recruited to the clustered (by school) randomised trial, with even randomisation to the intervention and control arms. Between 2003 and 2006, the VIP program was administered to 1,267 participants in the intervention schools, while 1,567 participants in the non-intervention schools received standard curriculum. Participants were all female and aged between 13-15 years upon recruitment. Pre and post-intervention questionnaires measured short-term impact and participants are now being followed through their teenage years via data linkage to hospital medical records, abortion clinics and education records. Participants who have a live birth are interviewed by face-to-face interview. Kaplan-Meier survival analysis and proportional hazards regression will test for differences in pregnancy, birth and abortion rates during the teenage years between the study arms. This protocol paper provides a detailed overview of the trial design as well as initial results in the form of participant flow. The authors describe the intervention and its delivery within the natural school setting and discuss the practical issues in the conduct of the trial, including recruitment. The trial is pragmatic and will directly inform those who provide Infant Simulator based programs in school settings. ISRCTN24952438.

Introduction to a Special Issue of the Journal of Immunological Methods: Building global resource programs to support HIV/AIDS clinical trial studies.

PubMed

Sanchez, Ana M; Denny, Thomas N; O'Gorman, Maurice

2014-07-01

This Special Issue of the Journal of Immunological Methods includes 16 manuscripts describing quality assurance activities related to virologic and immunologic monitoring of six global laboratory resource programs that support international HIV/AIDS clinical trial studies: Collaboration for AIDS Vaccine Discovery (CAVD); Center for HIV/AIDS Vaccine Immunology (CHAVI); External Quality Assurance Program Oversight Laboratory (EQAPOL); HIV Vaccine Trial Network (HVTN); International AIDS Vaccine Initiative (IAVI); and Immunology Quality Assessment (IQA). The reports from these programs address the many components required to develop comprehensive quality control activities and subsequent quality assurance programs for immune monitoring in global clinical trials including: all aspects of processing, storing, and quality assessment of PBMC preparations used ubiquitously in HIV clinical trials, the development and optimization of assays for CD8 HIV responses and HIV neutralization, a comprehensive global HIV virus repository, and reports on the development and execution of novel external proficiency testing programs for immunophenotyping, intracellular cytokine staining, ELISPOT and luminex based cytokine measurements. In addition, there are articles describing the implementation of Good Clinical Laboratory Practices (GCLP) in a large quality assurance laboratory, the development of statistical methods specific for external proficiency testing assessment, a discussion on the ability to set objective thresholds for measuring rare events by flow cytometry, and finally, a manuscript which addresses a framework for the structured reporting of T cell immune function based assays. It is anticipated that this series of manuscripts covering a wide range of quality assurance activities associated with the conduct of global clinical trials will provide a resource for individuals and programs involved in improving the harmonization, standardization, accuracy, and sensitivity of virologic and immunologic testing. Copyright © 2014 Elsevier B.V. All rights reserved.

Biological control of Heterodera glycines by spore-forming plant growth-promoting rhizobacteria (PGPR) on soybean.

PubMed

Xiang, Ni; Lawrence, Kathy S; Kloepper, Joseph W; Donald, Patricia A; McInroy, John A

2017-01-01

Heterodera glycines, the soybean cyst nematode, is the most economically important plant-parasitic nematode on soybean production in the U.S. The objectives of this study were to evaluate the potential of plant growth-promoting rhizobacteria (PGPR) strains for mortality of H. glycines J2 in vitro and for reducing nematode population density on soybean in greenhouse, microplot, and field trials. The major group causing mortality to H. glycines in vitro was the genus Bacillus that consisted of 92.6% of the total 663 PGPR strains evaluated. The subsequent greenhouse, microplot, and field trials indicated that B. velezensis strain Bve2 consistently reduced H. glycines cyst population density at 60 DAP. Bacillus mojavensis strain Bmo3 suppressed H. glycines cyst and total H. glycines population density under greenhouse conditions. Bacillus safensis strain Bsa27 and Mixture 1 (Bve2 + Bal13) reduced H. glycines cyst population density at 60 DAP in the field trials. Bacillus subtilis subsp. subtilis strains Bsssu2 and Bsssu3, and B. velezensis strain Bve12 increased early soybean growth including plant height and plant biomass in the greenhouse trials. Bacillus altitudinis strain Bal13 increased early plant growth on soybean in the greenhouse and microplot trials. Mixture 2 (Abamectin + Bve2 + Bal13) increased early plant growth in the microplot trials at 60 DAP, and also enhanced soybean yield at harvest in the field trials. These results demonstrated that individual PGPR strains and mixtures can reduce H. glycines population density in the greenhouse, microplot, and field conditions, and increased yield of soybean.

Sequential analysis applied to clinical trials in dentistry: a systematic review.

PubMed

Bogowicz, P; Flores-Mir, C; Major, P W; Heo, G

2008-01-01

Clinical trials employ sequential analysis for the ethical and economic benefits it brings. In dentistry, as in other fields, resources are scarce and efforts are made to ensure that patients are treated ethically. The objective of this systematic review was to characterise the use of sequential analysis for clinical trials in dentistry. We searched various databases from 1900 through to January 2008. Articles were selected for review if they were clinical trials in the field of dentistry that had applied some form of sequential analysis. Selection was carried out independently by two of the authors. We included 18 trials from various specialties, which involved many different interventions. We conclude that sequential analysis seems to be underused in this field but that there are sufficient methodological resources in place for future applications.Evidence-Based Dentistry (2008) 9, 55-62. doi:10.1038/sj.ebd.6400587.

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

PubMed

Lindberg, Lene; Ulfsdotter, Malin; Jalling, Camilla; Skärstrand, Eva; Lalouni, Maria; Lönn Rhodin, Kajsa; Månsdotter, Anna; Enebrink, Pia

2013-07-29

In recent decades, parents have been involved in programs that aim to improve parenting style and reduce child behavior problems. Research of preventive parenting programs has shown that these interventions generally have a positive influence on both parents and children. However, to our knowledge there is a gap in the scientific literature when it comes to randomized controlled trials of brief, manual-based structured programs which address general parenting among the population, and focus on promoting health. A four-session universal health promotion parent group program named All Children in Focus was developed. It aims at promoting parental competence and children's positive development with the parent-child relationship as the target. There is currently no randomized controlled trial existing of the program. A prospective multicenter randomized wait-list controlled trial is being conducted. Approximately 600 parents with children ranging in age from 3-12 years have been recruited in eleven municipalities and city districts in the County of Stockholm, Sweden. Parents are randomized at baseline to an intervention group, which receives the program directly, or to a waiting-list control group, which participates in the program six months later. Changes in parenting and child health and development are assessed with measures immediately post-intervention and six months after the baseline. Observations of a minor group of parents and children are conducted to explore possible relations between parental reports and observed behaviors, as well as changes in the interaction between parent and child. Further, data collected within the evaluation will also be applied to evaluate the possible cost-effectiveness of the program. This paper describes a study protocol of a randomized controlled trial. Except for the quantitative outcome measures to evaluate the effectiveness of All Children in Focus, this protocol also describes health economic and qualitative analyses to deepen the knowledge of the program. We further discuss some issues regarding the implementation of the program in municipalities and city districts. Current Controlled Trials ISRCTN70202532.

Munitions and Explosives of Concern Survey Methodology and In-field Testing for Wind Energy Areas on the Atlantic Outer Continental Shelf

NASA Astrophysics Data System (ADS)

DuVal, C.; Carton, G.; Trembanis, A. C.; Edwards, M.; Miller, J. K.

2017-12-01

Munitions and explosives of concern (MEC) are present in U.S. waters as a result of past and ongoing live-fire testing and training, combat operations, and sea disposal. To identify MEC that may pose a risk to human safety during development of offshore wind facilities on the Atlantic Outer Continental Shelf (OCS), the Bureau of Ocean Energy Management (BOEM) is preparing to develop guidance on risk analysis and selection processes for methods and technologies to identify MEC in Wind Energy Areas (WEA). This study developed a process for selecting appropriate technologies and methodologies for MEC detection using a synthesis of historical research, physical site characterization, remote sensing technology review, and in-field trials. Personnel were tasked with seeding a portion of the Delaware WEA with munitions surrogates, while a second group of researchers not privy to the surrogate locations tested and optimized the selected methodology to find and identify the placed targets. This in-field trial, conducted in July 2016, emphasized the use of multiple sensors for MEC detection, and led to further guidance for future MEC detection efforts on the Atlantic OCS. An April 2017 follow on study determined the fate of the munitions surrogates after the Atlantic storm season had passed. Using regional hydrodynamic models and incorporating the recommendations from the 2016 field trial, the follow on study examined the fate of the MEC and compared the findings to existing research on munitions mobility, as well as models developed as part of the Office of Naval Research Mine-Burial Program. Focus was given to characterizing the influence of sediment type on surrogate munitions behavior and the influence of mophodynamics and object burial on MEC detection. Supporting Mine-Burial models, ripple bedforms were observed to impede surrogate scour and burial in coarse sediments, while surrogate burial was both predicted and observed in finer sediments. Further, incorporation of recommendations from the previous trial in the 2017 study led to fourfold improvement of MEC detection rates over the 2016 approach. The use of modeling to characterize local morphodynamics, MEC burial or mobility, and the impact of seasonal or episodic storm events are discussed in light of technology selection and timing for future MEC detection surveys.

Adaptation and dissemination of an evidence-based obesity prevention intervention: design of a comparative effectiveness trial.

PubMed

Buscemi, Joanna; Odoms-Young, Angela; Stolley, Melinda L; Blumstein, Lara; Schiffer, Linda; Berbaum, Michael L; McCaffrey, Jennifer; Montoya, Anastasia McGee; Braunschweig, Carol; Fitzgibbon, Marian L

2014-07-01

Low-income youth are at increased risk for excess weight gain. Although evidence-based prevention programs exist, successful adaptation to provide wide dissemination presents a challenge. Hip-Hop to Health (HH) is a school-based obesity prevention intervention that targets primarily preschool children of low-income families. In a large randomized controlled trial, HH was found to be efficacious for prevention of excessive weight gain. The Expanded Food and Nutrition Education Program (EFNEP) and the Supplemental Nutrition Assistance Program-Education (SNAP-Ed) are USDA-funded nutrition education programs offered to low-income families, and may provide an ideal platform for the wide dissemination of evidence-based obesity prevention programs. A research-practice partnership was established in order to conduct formative research to guide the adaptation and implementation of HH through EFNEP and SNAP-Ed. We present the design and method of a comparative effectiveness trial that will determine the efficacy of HH when delivered by peer educators through these programs compared to the standard EFNEP and SNAP-Ed nutrition education (NE) curriculum. Results from this trial will inform larger scale dissemination. The dissemination of HH through government programs has the potential to increase the reach of efficacious obesity prevention programs that target low-income children and families. Copyright © 2014 Elsevier Inc. All rights reserved.

Adaptation and Dissemination of an Evidence-Based Obesity Prevention Intervention: Design of a Comparative Effectiveness Trial

PubMed Central

Buscemi, Joanna; Odoms-Young, Angela; Stolley, Melinda L.; Blumstein, Lara; Schiffer, Linda; Berbaum, Michael L.; McCaffrey, Jennifer; Montoya, Anastasia McGee; Braunschweig, Carol; Fitzgibbon, Marian L.

2014-01-01

Low-income youth are at increased risk for excess weight gain. Although evidence-based prevention programs exist, successful adaptation to provide wide dissemination presents a challenge. Hip-Hop to Health (HH) is a school-based obesity prevention intervention that targets primarily preschool children of low-income families. In a large randomized controlled trial, HH was found to be efficacious for prevention of excessive weight gain. The Expanded Food and Nutrition Education Program (EFNEP) and the Supplemental Nutrition Assistance Program--Education (SNAP-Ed) are USDA-funded nutrition education programs offered to low-income families, and may provide an ideal platform for the wide dissemination of evidence-based obesity prevention programs. A research-practice partnership was established in order to conduct formative research to guide the adaptation and implementation of HH through EFNEP and SNAP-Ed. We present the design and method of a comparative effectiveness trial that will determine the efficacy of HH when delivered by peer educators through these programs compared to the standard EFNEP and SNAP-Ed nutrition education (NE) curriculum. Results from this trial will inform larger scale dissemination. The dissemination of HH through government programs has the potential to increase the reach of efficacious obesity prevention programs that target low-income children and families. PMID:24952282

Cow and herd variation in milk urea nitrogen concentrations in lactating dairy cattle.

PubMed

Aguilar, M; Hanigan, M D; Tucker, H A; Jones, B L; Garbade, S K; McGilliard, M L; Stallings, C C; Knowlton, K F; James, R E

2012-12-01

Milk urea nitrogen (MUN) is correlated with N balance, N intake, and dietary N content, and thus is a good indicator of proper feeding management with respect to protein. It is commonly used to monitor feeding programs to achieve environmental goals; however, genetic diversity also exists among cows. It was hypothesized that phenotypic diversity among cows could bias feed management decisions when monitoring tools do not consider genetic diversity associated with MUN. The objective of the work was to evaluate the effect of cow and herd variation on MUN. Data from 2 previously published research trials and a field trial were subjected to multivariate regression analyses using a mixed model. Analyses of the research trial data showed that MUN concentrations could be predicted equally well from diet composition, milk yield, and milk components regardless of whether dry matter intake was included in the regression model. This indicated that cow and herd variation could be accurately estimated from field trial data when feed intake was not known. Milk urea N was correlated with dietary protein and neutral detergent fiber content, milk yield, milk protein content, and days in milk for both data sets. Cow was a highly significant determinant of MUN regardless of the data set used, and herd trended to significance for the field trial data. When all other variables were held constant, a percentage unit change in dietary protein concentration resulted in a 1.1mg/dL change in MUN. Least squares means estimates of MUN concentrations across herds ranged from a low of 13.6 mg/dL to a high of 17.3 mg/dL. If the observed MUN for the high herd were caused solely by high crude protein feeding, then the herd would have to reduce dietary protein to a concentration of 12.8% of dry matter to achieve a MUN concentration of 12 mg/dL, likely resulting in lost milk production. If the observed phenotypic variation is due to genetic differences among cows, genetic choices could result in herds that exceed target values for MUN when adhering to best management practices, which is consistent with the trend for differences in MUN among herds. Copyright © 2012 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

PUPTH Prehospital Air Medical Plasma (PAMP) Trial

DTIC Science & Technology

2014-07-01

collection of information, including suggestions for reducing this burden to Department of Defense, Washington Headquarters Services, Directorate for...projects. Scott Gunn, MD, is an Associate Professor of CCM and Emergency Medicine and Director , Combined Emergency Medicine/Internal Medicine/CCM...Residency Program. Dr. Gunn is also Director of the CCM Clinical Trials Program. As such, he is experienced in the design and monitoring of clinical trials

New Round of Studies Begin in Phase 0/I/II Cancer Prevention Clinical Trials Program | Division of Cancer Prevention

Cancer.gov

The NCI Division of Cancer Prevention’s Phase 0/I/II Cancer Prevention Clinical Trials Program, also known as the Consortia for Early Phase Prevention Trials, is beginning a new round of studies in the effort toward systematic early clinical development of promising preventive agents for people at increased risk of developing cancer. |

The Prevention Program for Externalizing Problem Behavior (PEP) Improves Child Behavior by Reducing Negative Parenting: Analysis of Mediating Processes in a Randomized Controlled Trial

ERIC Educational Resources Information Center

Hanisch, Charlotte; Hautmann, Christopher; Plück, Julia; Eichelberger, Ilka; Döpfner, Manfred

2014-01-01

Background: Our indicated Prevention program for preschool children with Externalizing Problem behavior (PEP) demonstrated improved parenting and child problem behavior in a randomized controlled efficacy trial and in a study with an effectiveness design. The aim of the present analysis of data from the randomized controlled trial was to identify…

Recruitment to and pilot results of the PACES randomized trial of physical exercise during adjuvant chemotherapy for colon cancer.

PubMed

van Waart, Hanna; Stuiver, Martijn M; van Harten, Wim H; Geleijn, Edwin; de Maaker-Berkhof, Marianne; Schrama, Jolanda; Geenen, Maud M; Meerum Terwogt, Jetske M; van den Heiligenberg, Simone M; Hellendoorn-van Vreeswijk, Jeannette A J H; Sonke, Gabe S; Aaronson, Neil K

2018-01-01

We report the recruitment rate, reasons for and factors influencing non-participation, and descriptive results of a randomized controlled trial of two different exercise programs for patients with colon cancer undergoing adjuvant chemotherapy. Participants were randomized to a low-intensity, home-based program (Onco-Move), a moderate- to high-intensity, combined supervised resistance and aerobic exercise program (OnTrack), or Usual Care. Non-participants provided reasons for non-participation and were asked to complete a questionnaire assessing behavioral and attitudinal variables. Trial participants completed performance-based and self-reported outcome measures prior to randomization, at the end of chemotherapy, and at the 6-month follow-up. Twenty-three of 63 referred patients agreed to participate in the trial. All 40 non-participants provided reasons for non-participation. Forty-five percent of the non-participants completed the questionnaire. Those who did not want to exercise had higher fatigue scores at baseline and a more negative attitude toward exercise. Compliance to both programs was high and no adverse events occurred. On average, the colon cancer participants were able to maintain or improve their physical fitness levels and maintain or decrease their fatigue levels during chemotherapy and follow-up. Recruitment of patients with colon cancer to a physical exercise trial during adjuvant chemotherapy proved to be difficult, underscoring the need to develop more effective strategies to increase participation rates. Both home-based and supervised programs are safe and feasible in patients with colon cancer undergoing chemotherapy. Effectiveness needs to be established in a larger trial. Netherlands Trial Register - NTR2159.

An index approach to performance-based payments for water quality.

PubMed

Maille, Peter; Collins, Alan R

2012-05-30

In this paper we describe elements of a field research project that presented farmers with economic incentives to control nitrate runoff. The approach used is novel in that payments are based on ambient water quality and water quantity produced by a watershed rather than proxies for water quality conservation. Also, payments are made based on water quality relative to a control watershed, and therefore, account for stochastic fluctuations in background nitrate levels. Finally, the program pays farmers as a group to elicit team behavior. We present our approach to modeling that allowed us to estimate prices for water and resulting payment levels. We then compare these preliminary estimates to the actual values recorded over 33 months of fieldwork. We find that our actual payments were 29% less than our preliminary estimates, due in part to the failure of our ecological model to estimate discharge accurately. Despite this shortfall, the program attracted the participation of 53% of the farmers in the watershed, and resulted in substantial nitrate abatement activity. Given this favorable response, we propose that research efforts focus on implementing field trials of group-level performance-based payments. Ideally these programs would be low risk and control for naturally occurring contamination. Copyright © 2012 Elsevier Ltd. All rights reserved.

Field trial of solvent-free emulsion in Oregon : final report.

DOT National Transportation Integrated Search

2003-03-01

This final report summarizes construction, laboratory and performance information gathered by ODOT personnel from a single field trial of solvent-free emulsion mix constructed in June 2001. The solvent-free emulsion mix presented several placement pr...

The Siren's Song: Exploitation of Female Flight Tones to Passively Capture Male Aedes aegypti (Diptera: Culicidae).

PubMed

Johnson, Brian J; Ritchie, Scott A

2016-01-01

The need to capture male mosquitoes has intensified recently as a result of a number of male-based sterile insect technique (SIT) and population-modification programs focused on Aedes aegypti (L.) having initiated field releases. Here, we report the results of the successful exploitation of the attraction of male Ae. aegypti to female flight tones to enhance male collections in nonmechanical passive (nonbattery powered) Gravid Aedes Traps (GAT). Prior to field studies, male attraction to female flight tones of 484 and 560 Hz, as well as to a male flight tone of 715 Hz, were assessed in a series of controlled release-recapture and semifield trials. These trials determined that a pure tone of 484 Hz was significantly more attractive to free-flying males than the other flight tones and enabled their collection in sound-baited GATs (ca. 95% capture rate after 2 h; 484 Hz at 65 dB). In contrast, gravid females were unresponsive to male or female flight tones and were evenly distributed among sound-baited and control GATs. Importantly, under normal field conditions sound-baited GATs (484 Hz at 70 dB) captured significantly more male Ae. aegypti per 24-h trap interval (1.3 ± 0.37) than controls (0.2 ± 0.13). Overall, sound-bated GATs captured approximately twice as many Ae. aegypti (male and female; 3.0 ± 0.68 per interval, 30 total) than controls (1.5 ± 0.56 per interval, 15 total). These results reveal that sound-baited GATs are a simple and effective surveillance tool for Ae. aegypti that would allow current male-based SIT and population-modification programs to effectively monitor males in their target populations. © The Authors 2015. Published by Oxford University Press on behalf of Entomological Society of America. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Webcam Delivery of the Camperdown Program for Adolescents Who Stutter: A Phase I Trial

ERIC Educational Resources Information Center

Carey, Brenda; O'Brian, Sue; Onslow, Mark; Packman, Ann; Menzies, Ross

2012-01-01

Purpose: This Phase I clinical trial explored the viability of webcam Internet delivery of the Camperdown Program for adolescents who stutter. Method and Procedure: Participants were 3 adolescents ages 13, 15, and 16 years, with moderate-severe stuttering. Each was treated with the Camperdown Program delivered by webcam with no clinic attendance.…

Randomized, Controlled Trial of a Comprehensive Program for Young Students with Autism Spectrum Disorder

ERIC Educational Resources Information Center

Young, Helen E.; Falco, Ruth A.; Hanita, Makoto

2016-01-01

This randomized, controlled trial, comparing the Comprehensive Autism Program (CAP) and business as usual programs, studied outcomes for 3-5 year old students with autism spectrum disorder (ASD). Participants included 84 teachers and 302 students with ASD and their parents. CAP utilized specialized curricula and training components to implement…

A Randomized Trial of a Multimodal Community-Based Prisoner Reentry Program Emphasizing Substance Abuse Treatment

ERIC Educational Resources Information Center

Grommon, Eric; Davidson, William S., II; Bynum, Timothy S.

2013-01-01

Prisoner reentry programs continue to be developed and implemented to ease the process of transition into the community and to curtail fiscal pressures. This study describes and provides relapse and recidivism outcome findings related to a randomized trial evaluating a multimodal, community-based reentry program that prioritized substance abuse…

Competition Between Fusarium pseudograminearum and Cochliobolus sativus Observed in Field and Greenhouse Studies.

PubMed

Troth, Erin E Gunnink; Johnston, Jeffrey A; Dyer, Alan T

2018-02-01

Among root pathogens, one of the most documented antagonisms is the suppression of Cochliobolus sativus by Fusarium (roseum) species. Unfortunately, previous studies involved single isolates of each pathogen and thus, provided no indication of the spectrum of responses that occur across the respective species. To investigate the variability in interactions between Cochliobolus sativus and Fusarium pseudograminearum, field and greenhouse trials were conducted that included monitoring of spring wheat plant health and monitoring of pathogen populations via quantitative real-time polymerase chain reaction. The interactions between two isolates of C. sativus and four isolates of F. pseudograminearum were explored in three geographically distinct wheat fields. To complement field trials and to limit potentially confounding environmental variables that are often associated with field studies, greenhouse trials were performed that investigated the interactions among and between three isolates of C. sativus and four isolates of F. pseudograminearum. Across field locations, C. sativus isolate Cs2344 consistently and significantly reduced Fusarium populations by an average of 20.1%. Similarly, F. pseudograminearum isolate Fp2228 consistently and significantly reduced C. sativus field populations by an average of 30.9%. No interaction was detected in the field between pathogen species with regards to disease or crop losses. Greenhouse results confirmed a powerful (>99%), broadly effective suppression of Fusarium populations by isolate Cs2344. Among greenhouse trials, additional isolate-isolate interactions were observed affecting Fusarium populations. Due to lower C. sativus population sizes in greenhouse trials, significant Fusarium suppression of C. sativus was only detected in one isolate-isolate interaction. This study is the first to demonstrate suppression of Fusarium spp. by C. sativus in field and greenhouse settings. These findings also reveal a complex competitive interaction between these two pathogen species that was previously unknown.

The effectiveness of alternative planned durations of residential drug abuse treatment.

PubMed Central

McCusker, J; Vickers-Lahti, M; Stoddard, A; Hindin, R; Bigelow, C; Zorn, M; Garfield, F; Frost, R; Love, C; Lewis, B

1995-01-01

Randomized controlled trials were conducted at two residential drug abuse treatment facilities to compare programs that differed in planned duration. One trial compared a 6-month and a 12-month therapeutic community program (n = 184), and the second compared a 3-month and a 6-month relapse prevention program (n = 444). Retention rates over comparable time periods differed minimally by planned treatment duration, and the longer programs had lower completion rates. There was no effect in either trial of planned treatment duration on changes in psychosocial variables between admission and exit or on rates or patterns of drug use at follow-up between 2 and 6 months after exit. PMID:7573630

Effectiveness of Exercise Programs in Ankylosing Spondylitis: A Meta-Analysis of Randomized Controlled Trials.

PubMed

Pécourneau, Virginie; Degboé, Yannick; Barnetche, Thomas; Cantagrel, Alain; Constantin, Arnaud; Ruyssen-Witrand, Adeline

2018-02-01

To assess the effectiveness of exercise programs on disease activity and function in ankylosing spondylitis (AS) by a systematic review and meta-analysis of randomized controlled trials (RCTs). Medline via PubMed and Cochrane Library. Reports of RCTs examining the effectiveness of exercise programs for AS published up to May 2017. Outcomes were evolution of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Bath Ankylosing Spondylitis Functional Index (BASFI) after the completion of exercise programs. Modalities of exercise were compared and the use of biologic therapy was reported. After screening 190 abstracts, we selected 26 reports for detailed evaluation and finally investigated 8 trials that assessed a home-based exercise program (2/8), swimming (1/8), Pilates training (1/8), or supervised exercises (4/8), for a total of 331 patients with AS. Four trials included patients receiving antitumor necrosis factor therapy. All trials except one showed a decrease in BASDAI and BASFI with exercise. The weighted mean difference was -0.90 (95% confidence interval, -1.52 to -0.27; I 2 =69%; P=.005) for the BASDAI and -0.72 (95% confidence interval, -1.03 to -0.40; I 2 =0%; P<.00001) for the BASFI in favor of exercise programs. Despite the small number of patients and the heterogeneity of exercise programs in the RCTs included in this meta-analysis, its results support the potential of exercise programs to improve disease activity and body function in AS. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Theory-and evidence-based development and process evaluation of the Move More for Life program: a tailored-print intervention designed to promote physical activity among post-treatment breast cancer survivors

PubMed Central

2013-01-01

Objective Several physical activity interventions have been effective in improving the health outcomes of breast cancer survivors. However, few interventions have provided detailed descriptions regarding how such interventions work. To develop evidence-based practice in this field, detailed descriptions of intervention development and delivery is needed. This paper aims to (1) describe the theory-and evidence-based development of the Move More for Life program, a physical activity program for breast cancer survivors; and (2) serve as an exemplar for theory-based applied research. Method The program-planning model outlined by Kreuter and colleagues was used to develop the computer-tailored intervention. Results The tailoring guide developed by Kreuter and colleagues served as a useful program planning tool in terms of integrating theory and evidence-based best practice into intervention strategies. Overall, participants rated the intervention positively, with the majority reporting that the tailored materials caught their attention, were personally relevant to them, and were useful for helping them to change their behaviour. However, there was considerable room for improvement. Conclusion The Move More for Life program is an example of a theory-based, low-cost and potentially sustainable strategy to physical activity promotion and may stand as an exemplar for Social Cognitive Theory-based applied research. By providing a detailed description of the development of the Move More for Life program, a critical evaluation of the working mechanisms of the intervention is possible, and will guide researchers in the replication or adaption and re-application of the specified techniques. This has potential implications for researchers examining physical activity promotion among cancer survivors and for researchers exploring distance-based physical activity promotion techniques among other populations. Trial registrations Australian New Zealand Clinical Trials Registry (ANZCTR) identifier: ACTRN12611001061921. PMID:24192320

Effectiveness of disease-management programs for improving diabetes care: a meta-analysis.

PubMed

Pimouguet, Clément; Le Goff, Mélanie; Thiébaut, Rodolphe; Dartigues, Jean François; Helmer, Catherine

2011-02-08

We conducted a meta-analysis of randomized controlled trials to assess the effectiveness of disease-management programs for improving glycemic control in adults with diabetes mellitus and to study which components of programs are associated with their effectiveness. We searched several databases for studies published up to December 2009. We included randomized controlled trials involving adults with type 1 or 2 diabetes that evaluated the effect of disease-management programs on glycated hemoglobin (hemoglobin A₁(C)) concentrations. We performed a meta-regression analysis to determine the effective components of the programs. We included 41 randomized controlled trials in our review. Across these trials, disease-management programs resulted in a significant reduction in hemoglobin A₁(C) levels (pooled standardized mean difference between intervention and control groups -0.38 [95% confidence interval -0.47 to -0.29], which corresponds to an absolute mean difference of 0.51%). The finding was robust in the sensitivity analyses based on quality assessment. Programs in which the disease manager was able to start or modify treatment with or without prior approval from the primary care physician resulted in a greater improvement in hemoglobin A₁(C) levels (standardized mean difference -0.60 v. -0.28 in trials with no approval to do so; p < 0.001). Programs with a moderate or high frequency of contact reported a significant reduction in hemoglobin A₁(C) levels compared with usual care; nevertheless, only programs with a high frequency of contact led to a significantly greater reduction compared with low-frequency contact programs (standardized mean difference -0.56 v. -0.30, p = 0.03). Disease-management programs had a clinically moderate but significant impact on hemoglobin A₁(C) levels among adults with diabetes. Effective components of programs were a high frequency of patient contact and the ability for disease managers to adjust treatment with or without prior physician approval.

Effectiveness of disease-management programs for improving diabetes care: a meta-analysis

PubMed Central

Pimouguet, Clément; Le Goff, Mélanie; Thiébaut, Rodolphe; Dartigues, Jean François; Helmer, Catherine

2011-01-01

Background We conducted a meta-analysis of randomized controlled trials to assess the effectiveness of disease-management programs for improving glycemic control in adults with diabetes mellitus and to study which components of programs are associated with their effectiveness. Methods We searched several databases for studies published up to December 2009. We included randomized controlled trials involving adults with type 1 or 2 diabetes that evaluated the effect of disease-management programs on glycated hemoglobin (hemoglobin A1C) concentrations. We performed a meta-regression analysis to determine the effective components of the programs. Results We included 41 randomized controlled trials in our review. Across these trials, disease-management programs resulted in a significant reduction in hemoglobin A1C levels (pooled standardized mean difference between intervention and control groups −0.38 [95% confidence interval −0.47 to −0.29], which corresponds to an absolute mean difference of 0.51%). The finding was robust in the sensitivity analyses based on quality assessment. Programs in which the disease manager was able to start or modify treatment with or without prior approval from the primary care physician resulted in a greater improvement in hemoglobin A1C levels (standardized mean difference −0.60 v. −0.28 in trials with no approval to do so; p < 0.001). Programs with a moderate or high frequency of contact reported a significant reduction in hemoglobin A1C levels compared with usual care; nevertheless, only programs with a high frequency of contact led to a significantly greater reduction compared with low-frequency contact programs (standardized mean difference −0.56 v. −0.30, p = 0.03). Interpretation Disease-management programs had a clinically moderate but significant impact on hemoglobin A1C levels among adults with diabetes. Effective components of programs were a high frequency of patient contact and the ability for disease managers to adjust treatment with or without prior physician approval. PMID:21149524

Balance training and center-of-pressure location in participants with chronic ankle instability.

PubMed

Mettler, Abby; Chinn, Lisa; Saliba, Susan A; McKeon, Patrick O; Hertel, Jay

2015-04-01

Chronic ankle instability (CAI) occurs in some people after a lateral ankle sprain and often results in residual feelings of instability and episodes of the ankle's giving way. Compared with healthy people, patients with CAI demonstrated poor postural control and used a more anteriorly and laterally positioned center of pressure (COP) during a single-limb static-balance task on a force plate. Balance training is an effective means of altering traditional COP measures; however, whether the overall location of the COP distribution under the foot also changes is unknown. To determine if the spatial locations of COP data points in participants with CAI change after a 4-week balance-training program. Randomized controlled trial. Laboratory. Thirty-one persons with self-reported CAI. Participants were randomly assigned to a 4-week balance-training program or no balance training. We collected a total of 500 COP data points while participants balanced using a single limb on a force plate during a 10-second trial. The location of each COP data point relative to the geometric center of the foot was determined, and the frequency count in 4 sections (anteromedial, anterolateral, posteromedial, posterolateral) was analyzed for differences between groups. Overall, COP position in the balance-training group shifted from being more anterior to less anterior in both eyes-open trials (before trial = 319.1 ± 165.4, after trial = 160.5 ± 149.5; P = .006) and eyes-closed trials (before trial = 387.9 ± 123.8, after trial = 189.4 ± 102.9; P < .001). The COP for the group that did not perform balance training remained the same in the eyes-open trials (before trial = 214.1 ± 193.3, after trial = 230.0 ± 176.3; P = .54) and eyes-closed trials (before trial = 326.9 ± 134.3, after trial = 338.2 ± 126.1; P = .69). In participants with CAI, the balance-training program shifted the COP location from anterolateral to posterolateral. The program may have repaired some of the damaged sensorimotor system pathways, resulting in a more optimally functioning and less constrained system.

A systematic review of randomised controlled trials on the effectiveness of exercise programs on Lumbo Pelvic Pain among postnatal women.

PubMed

Tseng, Pei-Ching; Puthussery, Shuby; Pappas, Yannis; Gau, Meei-Ling

2015-11-26

A substantial number of women tend to be affected by Lumbo Pelvic Pain (LPP) following child birth. Physical exercise is indicated as a beneficial method to relieve LPP, but individual studies appear to suggest mixed findings about its effectiveness. This systematic review aimed to synthesise evidence from randomised controlled trials on the effectiveness of exercise on LPP among postnatal women to inform policy, practice and future research. A systematic review was conducted of all randomised controlled trials published between January 1990 and July 2014, identified through a comprehensive search of following databases: PubMed, PEDro, Embase, Cinahl, Medline, SPORTDiscus, Cochrane Pregnancy and Childbirth Group's Trials Register, and electronic libraries of authors'institutions. Randomised controlled trials were eligible for inclusion if the intervention comprised of postnatal exercise for women with LPP onset during pregnancy or within 3 months after delivery and the outcome measures included changes in LPP. Selected articles were assessed using the PEDro Scale for methodological quality and findings were synthesised narratively as meta-analysis was found to be inappropriate due to heterogeneity among included studies. Four randomised controlled trials were included, involving 251 postnatal women. Three trials were rated as of 'good' methodological quality. All trials, except one, were at low risk of bias. The trials included physical exercise programs with varying components, differing modes of delivery, follow up times and outcome measures. Intervention in one trial, involving physical therapy with specific stabilising exercises, proved to be effective in reducing LPP intensity. An improvement in gluteal pain on the right side was reported in another trial and a significant difference in pain frequency in another. Our review indicates that only few randomised controlled trials have evaluated the effectiveness of exercise on LPP among postnatal women. There is also a great amount of variability across existing trials in the components of exercise programs, modes of delivery, follow up times and outcome measures. While there is some evidence to indicate the effectiveness of exercise for relieving LPP, further good quality trials are needed to ascertain the most effective elements of postnatal exercise programs suited for LPP treatment.

Modern Process Studies in Kongsfjord, Svalbard: Arctic Geoscience Research Experience for U.S. Undergraduates (Svalbard REU)

NASA Astrophysics Data System (ADS)

Powell, R. D.; Brigham-Grette, J.

2011-12-01

The Svalbard REU (Research Experience for Undergraduates) program focuses on understanding how high latitude glaciers, meltwater streams, and sedimentation in lakes and fjords respond to changing climate. Since summer of 2004, six under-graduate students have been selected to participate in the summer field program. Students work on individual projects and in close conjunction with faculty advisors and other student researchers. They formulate their own research questions, develop their project, and complete their field research during a five-week program on Svalbard, Norway. Following the summer program, students complete their projects at their home institution during the following academic year as a senior thesis. A spring symposium brings all participants back together again with their final results. The most recent field season was completed in Kongsfjord (79N) showing that the contemporary studies of tidewater glacier margins provide an unparalleled opportunity for introducing motivated third year undergraduate students to the challenges and rewards of polar geoscientific field research. Rates of rapid change in this high-latitude Arctic environment emphasize the complexity of the Earth System at the interface of the ocean, atmosphere and cryosphere. Given background information in glacial and marine geology, glaciology, hydrology, climatology and fjord oceanography not routinely offered in undergraduate curricula, students develop the science questions to be addressed and establish a field plan for instrumentation and sampling. Working together in small boats in one of the most challenging natural environments, the students expand their leadership skills, learn the value of teamwork and collaborative data sharing while maintaining a strong sense of ownership over their individual science projects. The rigors of studying an actively calving tidewater glacier also builds on their outdoor skills, especially when it is necessary to improvise and become resourceful due to instrumentation failures or weather-related delays. Self-confidence and problem solving skills emerge from both field and laboratory research operations when students draw upon and expand their base of practical knowledge via trial and error. Logistical facilities in Ny Alesund offer an international experience with opportunities for dialog with scientists of a wide variety of disciplines working at research stations representing more than 12 different European and Asian countries. The program is funded by the NSF's Office of Polar Programs and has close ties and collaboration with the Norwegian University in Svalbard (UNIS) and Norsk Polar Institute scientists. NSF also funds a science teacher as a PolarTREC participant.

Web-Based Intervention to Reduce Substance Abuse and Depressive Symptoms in Mexico: Development and Usability Test.

PubMed

Tiburcio, Marcela; Lara, Ma Asunción; Aguilar Abrego, Araceli; Fernández, Morise; Martínez Vélez, Nora; Sánchez, Alejandro

2016-09-29

The development of Web-based interventions for substance abuse in Latin America is a new field of interest with great potential for expansion to other Spanish-speaking countries. This paper describes a project aimed to develop and evaluate the usability of the Web-based Help Program for Drug Abuse and Depression (Programa de Ayuda para Abuso de Drogas y Depresión, PAADD, in Spanish) and also to construct a systematic frame of reference for the development of future Web-based programs. The PAADD aims to reduce substance use and depressive symptoms with cognitive behavioral techniques translated into Web applications, aided by the participation of a counselor to provide support and guidance. This Web-based intervention includes 4 steps: (1) My Starting Point, (2) Where Do I Want to Be? (3) Strategies for Change, and (4) Maintaining Change. The development of the program was an interactive multistage process. The first stage defined the core structure and contents, which were validated in stage 2 by a group of 8 experts in addiction treatment. Programming of the applications took place in stage 3, taking into account 3 types of end users: administrators, counselors, and substance users. Stage 4 consisted of functionality testing. In stage 5, a total of 9 health professionals and 20 drug users currently in treatment voluntarily interacted with the program in a usability test, providing feedback about adjustments needed to improve users' experience. The main finding of stage 2 was the consensus of the health professionals about the cognitive behavioral strategies and techniques included in PAADD being appropriate for changing substance use behaviors. In stage 5, the health professionals found the functionalities easy to learn; their suggestions were related to the page layout, inclusion of confirmation messages at the end of activities, avoiding "read more" links, and providing feedback about every activity. On the other hand, the users said the information presented within the modules was easy to follow and suggested more dynamic features with concrete instructions and feedback. The resulting Web-based program may have advantages over traditional face-to-face therapies owing to its low cost, wide accessibility, anonymity, and independence of time and distance factors. The detailed description of the process of designing a Web-based program is an important contribution to others interested in this field. The potential benefits must be verified in specific studies. International Standard Randomized Controlled Trial Number (ISRCTN): 25429892; http://www.controlled-trials.com/ISRCTN25429892 (Archived by WebCite at http://www.webcitation.org/6ko1Fsvym).

ELECTROCHEMICAL ARSENIC REMEDIATION IN RURAL BANGLADESH

EPA Science Inventory

In Year 1, we built a bench-scale continuous flow prototype (dubbed “Sushi” for its sushi-like electrode roll) and completed preliminary field trials in Bangladesh. We were also able to leverage additional funding to complete preliminary field trials in arsenic-...

Resistance training program for fatigue management in the workplace: exercise protocol in a cluster randomized controlled trial.

PubMed

Santos, Hélio Gustavo; Chiavegato, Luciana Dias; Valentim, Daniela Pereira; da Silva, Patricia Rodrigues; Padula, Rosimeire Simprini

2016-12-22

Fatigue is a multifactorial condition that leads to disease and loss in production, and it affects a large number of workers worldwide. This study aims to demonstrate a resistance exercise protocol that individuals will perform during the work schedule, and to evaluate the effectiveness of this exercises program for fatigue control. This is a cluster randomized controlled trial with two arms and is assessor blinded. A total of 352 workers of both sexes, aged 18-65 years, from a medium-sized dairy plant were enrolled in this study. Participants will be recruited from 13 production sectors according to the eligibility criteria and will be randomized by clusters to either the Progressive Resistance Exercise (PRE) intervention group or the Compensatory Workplace Exercise (CWE) comparative group. A resistance exercise program will be implemented for both groups. The groups will receive instructions on self-management, breaks, adjustments to workstations, and the benefits of physical exercise. The PRE group will perform resistance exercises with gradual loads in an exercise room, and the CWE group will perform exercise at their workstations using elastic bands. The exercise sessions will be held 3 times a week for 20 min. The primary outcome measures will be symptoms of physical and mental fatigue, and muscular fatigue based on a one-repetition maximum (1RM). The secondary outcome measures will be level of physical activity, musculoskeletal symptoms, physical condition, perceived exposure, and productivity. The workers will be assessed at baseline and after a 4-month program. A linear mixed model will be applied on an intention-to-treat basis. This intervention is expected to reduce symptoms of fatigue in the workers. The exercise program is indicating in the workplace, although there are few studies describing the effects of exercise on the control of fatigue in the workplace. Emphasis will be placed on adherence to the program, which may result in significant and clinically important reductions in fatigue. It is also expected that the findings of this study will contribute significantly to the decision-making capacity of professionals working in the field of occupational health. U.S. National Institutes of Health, ClinicalTrials.gov Identifier: NCT02172053 . Date registered 19 June 2014.

A cluster randomized Hybrid Type III trial testing an implementation support strategy to facilitate the use of an evidence-based practice in VA homeless programs.

PubMed

Smelson, David A; Chinman, Matthew; McCarthy, Sharon; Hannah, Gordon; Sawh, Leon; Glickman, Mark

2015-05-28

The Housing and Urban Development-Veterans Affairs Supportive Housing (HUD-VASH) program is one of the largest initiatives to end Veteran homelessness. However, mental health and substance use disorders continue to reduce client stability and impede program success. HUD-VASH programs do not consistently employ evidence-based practices that address co-occurring mental health and substance use disorders. This paper presents a study protocol to evaluate the implementation of an evidence-based, co-occurring disorder treatment called Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking-Veterans Edition (MISSION-Vet) in HUD-VASH using an implementation strategy called Getting To Outcomes (GTO). In three large VA Medical Centers, this Hybrid Type III trial will randomize case managers and their clients by HUD-VASH sub-teams to receive either MISSION-Vet Implementation as Usual (IU-standard training and access to the MISSION-Vet treatment manuals) or MISSION-Vet implementation augmented by GTO. In addition to testing GTO, effectiveness of the treatment (MISSION-Vet) will be assessed using existing Veteran-level data from the HUD-VASH data monitoring system. This project will compare GTO and IU case managers and their clients on the following variables: (1) fidelity to the MISSION-Vet intervention; (2) proportion of time the Veteran is housed; (3) mental health, substance use, and functional outcomes among Veterans; and (4) factors key to the successful deployment of a new treatment as specified by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) model. This project is an important step for developing an implementation strategy to increase adoption of evidence-based practice use in VA homeless programs, and to further examine efficacy of MISSION-Vet in HUD-VASH. This project has important implications for program managers, policy makers, and researchers within the homelessness field. VA Central IRB approval for this study was granted in October 2011. The three sites were trained on MISSION-Vet and GTO in the first half of 2013. The first GTO planning meetings began after training occurred, between January 2013 and November 2013, across the three sites. The data collection-via a fidelity measure embedded into the VA Computerized Patient Record System-began as each site initiated MISSION-Vet, between April 2013 and January 2014. ClinicalTrials.gov: NCT01430741.

Five-year field trials using preservative-treated, second-growth Douglas-fir exposed in ground contact in Australia

Treesearch

Rodney C. De Groot; Douglas M. Crawford; Jack Norton; John Keith

2000-01-01

The durability of preservative-treated stakes of second-growth Coastal Douglas-fir was evaluated in a field plot in northern Queensland, Australia. Results from this field trial indicate that second-growth Douglas-fir can be treated with preservatives to meet Australian standards and will provide long-term durability in adverse environments. Data presented indicate...

Nurse Family Partnership: Comparing Costs per Family in Randomized Trials Versus Scale-Up.

PubMed

Miller, Ted R; Hendrie, Delia

2015-12-01

The literature that addresses cost differences between randomized trials and full-scale replications is quite sparse. This paper examines how costs differed among three randomized trials and six statewide scale-ups of nurse family partnership (NFP) intensive home visitation to low income first-time mothers. A literature review provided data on pertinent trials. At our request, six well-established programs reported their total expenditures. We adjusted the costs to national prices based on mean hourly wages for registered nurses and then inflated them to 2010 dollars. A centralized data system provided utilization. Replications had fewer home visits per family than trials (25 vs. 31, p = .05), lower costs per client ($8860 vs. $12,398, p = .01), and lower costs per visit ($354 vs. $400, p = .30). Sample size limited the significance of these differences. In this type of labor intensive program, costs probably were lower in scale-up than in randomized trials. Key cost drivers were attrition and the stable caseload size possible in an ongoing program. Our estimates reveal a wide variation in cost per visit across six state programs, which suggests that those planning replications should not expect a simple rule to guide cost estimations for scale-ups. Nevertheless, NFP replications probably achieved some economies of scale.

An effectiveness trial of a new enhanced dissonance eating disorder prevention program among female college students.

PubMed

Stice, Eric; Butryn, Meghan L; Rohde, Paul; Shaw, Heather; Marti, C Nathan

2013-12-01

Efficacy trials indicate that a dissonance-based prevention program in which female high school and college students with body image concerns critique the thin-ideal reduced risk factors, eating disorder symptoms, and future eating disorder onset, but weaker effects emerged from an effectiveness trial wherein high school clinicians recruited students and delivered the program under real-world conditions. The present effectiveness trial tested whether a new enhanced dissonance version of this program produced larger effects when college clinicians recruited students and delivered the intervention using improved procedures to select, train, and supervise clinicians. Young women recruited from seven universities across the US (N = 408, M age = 21.6, SD = 5.64) were randomized to the dissonance intervention or an educational brochure control condition. Dissonance participants showed significantly greater decreases in risk factors (thin-ideal internalization, body dissatisfaction, dieting, negative affect) and eating disorder symptoms versus controls at posttest and 1-year follow-up, resulting in medium average effect size (d = .60). Dissonance participants also reported significant improvements in psychosocial functioning, but not reduced health care utilization or unhealthy weight gain. This novel multisite effectiveness trial with college clinicians found that the enhanced dissonance version of this program and the improved facilitator selection/training procedures produced average effects that were 83% larger than effects observed in the high school effectiveness trial. Copyright © 2013 Elsevier Ltd. All rights reserved.

A Multisite Randomized Trial of a Cognitive Skills Program for Male Mentally Disordered Offenders: Violence and Antisocial Behavior Outcomes

ERIC Educational Resources Information Center

Cullen, Alexis E.; Clarke, Amory Y.; Kuipers, Elizabeth; Hodgins, Sheilagh; Dean, Kimberlie; Fahy, Tom

2012-01-01

Objective: Despite a large evidence base indicating that cognitive skills programs can reduce reoffending in individuals without mental illness, there have been no randomized controlled trials (RCTs) to determine their effectiveness in mentally disordered offenders (MDOs). In the first RCT of a cognitive skills program for MDOs, we aimed to…

Alcohol-Specific Parenting within a Cluster-Randomized Effectiveness Trial of a Swedish Primary Prevention Program

ERIC Educational Resources Information Center

Strandberg, Anna K.; Bodin, Maria C.

2011-01-01

Purpose: Within the framework of an ongoing cluster-randomized effectiveness trial of a parental prevention program, the aim of the present study is to investigate attitudes towards under-age drinking and use of program components, i.e. alcohol-specific parenting behaviors, in parents who did and did not take part in the programme.…

A Controlled Trial of a Novel Primary Prevention Program for Lyme Disease and Other Tick-Borne Illnesses

ERIC Educational Resources Information Center

Daltroy, Lawren H.; Phillips, Charlotte; Lew, Robert; Wright, Elizabeth; Shadick, Nancy A.; Liang, Matthew H.

2007-01-01

To evaluate a theory-based educational program to prevent Lyme disease and other tick-borne illnesses (TBI), a randomized controlled trial of an educational program was delivered to ferry passengers traveling to an endemic area in southeastern Massachusetts. Rates of TBI and precautionary and tick check behaviors were measured over three summers…

WWC Review of the Report "Evaluation of the College Possible Program: Results from a Randomized Controlled Trial." What Works Clearinghouse Single Study Review

ERIC Educational Resources Information Center

What Works Clearinghouse, 2014

2014-01-01

The 2013 study, "Evaluation of the College Possible Program: Results From a Randomized Controlled Trial", investigated the effect of the "College Possible" program, which is designed to serve low-income high school students by providing SAT/ACT test preparation, financial aid consulting, and college admissions guidance in an…

The Results of a Randomized Control Trial Evaluation of the SPARK Literacy Program

ERIC Educational Resources Information Center

Jones, Curtis J.; Christian, Michael; Rice, Andrew

2016-01-01

The purpose of this report is to present the results of a two-year randomized control trial evaluation of the SPARK literacy program. SPARK is an early grade literacy program developed by Boys & Girls Clubs of Greater Milwaukee. In 2010, SPARK was awarded an Investing in Innovation (i3) Department of Education grant to further develop the…

[The development of educational CD-program for obesity prevention and management for primary school students].

PubMed

Kim, Yi-Soon; Ju, Hyeon-Ok; Song, Mi-Gyoung; Shin, Yoo-Sun

2003-02-01

The study is designed to develop an educational CD-Program for prevention and control of obesity among primary school students. The study is conducted from June 15, 2000 to April 15, 2002. Based on the course of program development suggested by Dick and Cray (1990), the study followed the planning, development, education and evaluation of a program. The developed CD-Program consists 2 parts each for lower and higher grades of primary school students. The introduction part of the first trial for lower grade students uses quiz to encourage their motivations, the body proceeds with motion pictures and animations to trigger their interests. The introduction part of the second trial for the lower grades consists of remembering the exhibition lecture. The first trial for higher grades of primary school students builds on the contents of the low grades. Its body part, how to determine obesity and calculate ones own obesity, puts ones own weight and height in by the mouse. For the second trial of the higher grades, the body consists of life-style, diet, and regiments. The merits of this CD-Program are that to be possible an interaction between teachers and students.

A semi-automated tool for treatment plan-quality evaluation and clinical trial quality assurance

NASA Astrophysics Data System (ADS)

Wang, Jiazhou; Chen, Wenzhou; Studenski, Matthew; Cui, Yunfeng; Lee, Andrew J.; Xiao, Ying

2013-07-01

The goal of this work is to develop a plan-quality evaluation program for clinical routine and multi-institutional clinical trials so that the overall evaluation efficiency is improved. In multi-institutional clinical trials evaluating the plan quality is a time-consuming and labor-intensive process. In this note, we present a semi-automated plan-quality evaluation program which combines MIMVista, Java/MATLAB, and extensible markup language (XML). More specifically, MIMVista is used for data visualization; Java and its powerful function library are implemented for calculating dosimetry parameters; and to improve the clarity of the index definitions, XML is applied. The accuracy and the efficiency of the program were evaluated by comparing the results of the program with the manually recorded results in two RTOG trials. A slight difference of about 0.2% in volume or 0.6 Gy in dose between the semi-automated program and manual recording was observed. According to the criteria of indices, there are minimal differences between the two methods. The evaluation time is reduced from 10-20 min to 2 min by applying the semi-automated plan-quality evaluation program.

PILOT TESTING: PRETREATMENT OPTIONS TO ALLOW RE-USE OF FRAC FLOWBACK AND PRODUCED BRINE FOR GAS SHALE RESOURCE DEVELOPMENT

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

Burnett, David

2012-12-31

The goal of the A&M DOE NETL Project No. DE-FE0000847 was to develop a mobile, multifunctional water treatment capability designed specifically for “pre-treatment” of field waste brine. The project consisted of constructing s mobile “field laboratory” incorporating new technology for treating high salinity produced water and using the lab to conduct a side-by-side comparison between this new technology and that already existing in field operations. A series of four field trials were performed utilizing the mobile unit to demonstrate the effectiveness of different technology suitable for use with high salinity flow back brines and produced water. The design of themore » mobile unit was based on previous and current work at the Texas A&M Separation Sciences Pilot Plant. The several treatment techniques which have been found to be successful in both pilot plant and field tests had been tested to incorporate into a single multifunctional process train. Eight different components were evaluated during the trials, two types of oil and grease removal, one BTEX removal step, three micro-filters, and two different nanofilters. The performance of each technique was measured by its separation efficiency, power consumption, and ability to withstand fouling. The field trials were a success. Four different field brines were evaluated in the first trial in New York. Over 16,000 gallons of brine were processed. Using a power cost of $.10 per kWh, media pretreatment power use averaged $0.004 per barrel, solids removal $.04 per barrel and brine “softening” $.84 per barrel. Total power cost was approximately $1.00 per barrel of fluid treated. In Pennsylvania, brines collected from frac ponds were tested in two additional trials. Each of the brines was converted to an oil-free, solids-free brine with no biological activity. Brines were stable over time and would be good candidates for use as a make-up fluid in a subsequent fracturing fluid design. Reports on all of the field trials and subcontractor research have been summarized in this Final Report. Individual field trial reports and research reports are contained in the companion volume titled “Appendices”« less

Interventions for preventing eating disorders in children and adolescents.

PubMed

Pratt, B M; Woolfenden, S R

2002-01-01

Eating disorders represent an extremely difficult condition to treat and patients consume an enormous amount of mental health energy and resources. Being young, female, and dieting are some of the few identified risk factors that have been reliably linked to the development of eating disorders, and several prevention eating disorder prevention programs have been developed and trialed with children and adolescents. The purpose of this systematic review is to evaluate the effectiveness of eating disorder prevention programs for children and adolescents both in the general population and those determined to be at risk. 1. To determine if eating disorder prevention programs are effective in promoting healthy eating attitudes and behaviours in children and adolescents; 2. To determine if eating disorder prevention programs are effective in promoting psychological factors that protect children and adolescents from developing eating disorders; 3. To determine if eating disorder prevention programs are effective in promoting satisfactory physical health in children and adolescents; 4. To determine if eating disorder prevention programs have a long-term, sustainable, and positive impact on the mental and physical health of children and adolescents; and, 5. To determine the safety of eating disorder prevention programs in terms of possible harmful consequences on the mental or physical health of children and adolescents. Relevant trials are identified through searching the Cochrane Controlled Trial Register (CCTR) and relevant biomedical and social science databases. All terms necessary to detect prevention programs and the participant groups are used. A strategy to locate randomised controlled trials is used. Other sources of information are the bibliographies of systematic and non-systematic reviews and reference lists from articles identified through the search strategy. In order to identify unpublished studies, experts in the field are contacted by letter and/or electronic mail. Randomised controlled trials (RCT) with a major focus on eating disorder prevention programs for children and adolescents, where there is no known DSM-IV diagnosis of an eating disorder, are eligible for inclusion in the review. Trials must include a control group and at least one objective outcome measure (eg. BMI) or a standardised psychological measure used with the intervention and control group, pre- and post-intervention. A total of 1379 titles have been identified through the search to date. 13 studies were located that reported use of a randomised controlled trial methodology and were critically appraised by two independent reviewers. Five (5) studies were excluded as data were not reported in a useable form or useable data could not be obtained from the trial authors, one dissertation could not be obtained, one study had no "true" no-treatment or usual treatment control group, and one study did not use a pre-test outcome measure. Eight (8) studies met the selection criteria outlined above. Only one of eight pooled comparisons of two or more studies using similar outcome measures and similar intervention types demonstrated the statistically significant effect of a particular type of eating disorder prevention program for children and adolescents. Combined data from two eating disorder prevention programs based on a media literacy and advocacy approach indicate a reduction in the internalisation or acceptance of societal ideals relating to appearance at a 3- to 6-month follow-up (Kusel, unpublished; Neumark-Sztainer2000) [SMD -0.28, -0.51 to -0.05, 95% CI]. However, there is insufficient evidence to conclude that this approach also demonstrated a significant impact on awareness of societal standards relating to appearance. There is insufficient evidence to support the effect of four programs designed to address eating attitudes and behaviours and other adolescent issues on body weight, eating disorder symptoms, associated eating disorder psychopathology or general psychological and physical well-being in the general sample or those classified as being at high risk for eating disorder (Buddeberg-F 1998; Killen 1993/1996; Santonastaso 1999; Zanetti 1999). Given only one program used a psychoeducation approach to prevent bulimia nervosa (Jerome, unpublished) and only one program adopted a focus on self-esteem (O'Dea 2000), the effect of these approaches could not be evaluated via meta-analyses. In relation to potential harmful effects, there is not sufficient evidence to suggest that harm resulted from any of the prevention programs included in the review. The one significant pooled effect in the current review does not allow for any firm conclusions to be made about the impact of prevention programs for eating disorders in children and adolescents, although none of the pooled comparisons indicated evidence of harm. From a clinical perspective, the development and refinement of prevention programs is complicated by a lack of knowledge about risk factors associated with eating disorders and the need to strike a balance between delivering preventive interventions for eating disorders and considering the potential to cause harm. From a research perspective, the idea of "thresholds" for identifying young people at risk of developing eating disorders has been raised, and denial of concern or denial of illness represents a further issue complicating early identification in relation to eating disorder symptomatology. Longer-term effects of the intervention approaches will need to be monitored across development in order to demonstrate a decline in the incidence of eating disorders and associated risk factors.

76 FR 38037 - Mevinphos; Data Call-in Order for Pesticide Tolerances

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-29

... residues of mevinphos on the following commodities: Broccoli, cabbage, cauliflower, celery, spinach... Field Trials (860.1500)--(broccoli, cabbage, cauliflower, celery, grapes, lettuce, peas, peppers... Not required October 1, 2012. 860.1500 Crop Field Trials Not Required September 30, 2013. (broccoli...

Ethical issues in field trials of genetically modified disease-resistant mosquitoes.

PubMed

Resnik, David B

2014-04-01

Mosquito-borne diseases take a tremendous toll on human populations, especially in developing nations. In the last decade, scientists have developed mosquitoes that have been genetically modified to prevent transmission of mosquito-borne diseases, and field trials have been conducted. Some mosquitoes have been rendered infertile, some have been equipped with a vaccine they transmit to humans, and some have been designed to resist diseases. This article focuses on ethical issues raised by field trials of disease-resistant, genetically modified mosquitoes. Some of these issues include: protecting the public and the environment from harm, balancing benefits and risks, collaborating with the local community, avoiding exploitation, and safeguarding the rights and welfare of research subjects. One of the most difficult problems involves protecting the welfare of community members who will be impacted by the release of mosquitoes but who are not enrolled in the study as research subjects. To address this concern, field trials should take place only when the targeted disease is a significant public health problem in an isolated area, the benefits of the trial for the community are likely to outweigh the risks, community leaders approve of the trial, and there are measures in place to protect the welfare of un-enrolled community members, such as informing the community about the study and offering free treatment to people who contract mosquito-borne diseases. Since the justification of any field trial depends on a careful examination of the scientific and ethical issues, proposed studies should be evaluated on a case-by-case basis. Published 2012. This article is a US Government work and is in the public domain in the USA.

Webcam delivery of the Lidcombe program for early stuttering: a phase I clinical trial.

PubMed

O'Brian, Sue; Smith, Kylie; Onslow, Mark

2014-06-01

The Lidcombe Program is an operant treatment for early stuttering shown with meta-analysis to have a favorable odds ratio. However, many clients are unable to access the treatment because of distance and lifestyle factors. In this Phase I trial, we explored the potential efficacy, practicality, and viability of an Internet webcam Lidcombe Program service delivery model. Participants were 3 preschool children who stuttered and their parents, all of whom received assessment and treatment using webcam in their homes with no clinic attendance. At 6 months post-Stage 1 completion, all children were stuttering below 1.0% syllables stuttered. The webcam intervention was acceptable to the parents and appeared to be practical and viable, with only occasional audiovisual problems. At present, there is no reason to doubt that a webcam-delivered Lidcombe Program will be shown with clinical trials to have comparable efficacy with the clinic version. Webcam-delivered Lidcombe Program intervention is potentially efficacious, is practical and viable, and requires further exploration with comparative clinical trials and a qualitative study of parent and caregiver experiences.

Effects of Data Sampling on Graphical Depictions of Learning

ERIC Educational Resources Information Center

Carey, Mary-Katherine; Bourret, Jason C.

2014-01-01

Continuous and discontinuous data-collection methods were compared in the context of discrete-trial programming. Archival data sets were analyzed using trial sampling (1st 5 trials, 1st 3 trials, and 1st trial only) and session sampling (every other session, every 3rd session, and every 5th session). Results showed that trial sampling…

Enrichment Strategies in Pediatric Drug Development: An Analysis of Trials Submitted to the US Food and Drug Administration.

PubMed

Green, Dionna J; Liu, Xiaomei I; Hua, Tianyi; Burnham, Janelle M; Schuck, Robert; Pacanowski, Michael; Yao, Lynne; McCune, Susan K; Burckart, Gilbert J; Zineh, Issam

2017-12-08

Clinical trial enrichment involves prospectively incorporating trial design elements that increase the probability of detecting a treatment effect. The use of enrichment strategies in pediatric drug development has not been systematically assessed. We analyzed the use of enrichment strategies in pediatric trials submitted to the US Food and Drug Administration from 2012-2016. In all, 112 efficacy studies associated with 76 drug development programs were assessed and their overall success rates were 78% and 75%, respectively. Eighty-eight trials (76.8%) employed at least one enrichment strategy; of these, 66.3% employed multiple enrichment strategies. The highest trial success rates were achieved when all three enrichment strategies (practical, predictive, and prognostic) were used together within a single trial (87.5%), while the lowest success rate was observed when no enrichment strategy was used (65.4%). The use of enrichment strategies in pediatric trials was found to be associated with trial and program success in our analysis. © 2017 American Society for Clinical Pharmacology and Therapeutics.

Two field trials for deblending of simultaneous source surveys: Why we failed and why we succeeded?

NASA Astrophysics Data System (ADS)

Zu, Shaohuan; Zhou, Hui; Chen, Haolin; Zheng, Hao; Chen, Yangkang

2017-08-01

Currently, deblending is the main strategy for dealing with the intense interference problem of simultaneous source data. Most deblending methods are based on the property that useful signal is coherent while the interference is incoherent in some domains other than common shot domain. In this paper, two simultaneous source field trials were studied in detail. In the first trial, the simultaneous source survey was not optimal, as the dithering code had strong coherency and the minimum distance between the two vessels was also small. The chosen marine shot scheduling and vessel deployment made it difficult to deblend the simultaneous source data, and result was an unexpected failure. Next, we tested different parameters (the dithering code and the minimum distance between vessels) of the simultaneous source survey using the simulated blended data and got some useful insights. Then, we carried out the second field trial with a carefully designed survey that was much different from the first trial. The deblended results in common receiver gather, common shot gather or the final stacked profile were encouraging. We obtained a complete success in the second field trial, which gave us confidence in the further test (such as a full three dimensional acquisition test or a high-resolution acquisition test with denser spatial sampling). Remembering that failures with simultaneous sourcing seldom reported, in this paper, our contribution is the discussion in detail about both our failed and successful field experiments and the lessons we have learned from them with the hope that the experience gained from this study can be very useful to other researchers in the same field.

Structure of NCI Cooperative Groups Program Prior to NCTN

Cancer.gov

Learn how the National Cancer Institute’s Cooperative Groups Program was structured prior to its being replaced by NCI’s National Clinical Trials Network (NCTN). The NCTN gives funds and other support to cancer research organizations to conduct cancer clinical trials.

Disruption of Darna pallivitta (Lepidoptera: Limacodidae) by Conventional and Mobile Pheromone Deployment

PubMed Central

Siderhurst, Matthew S.; Jang, Eric B.; Carvalho, Lori A. F. N.; Nagata, Janice T.; Derstine, Nathan T.

2015-01-01

Identification of the Darna pallivitta (Moore) pheromone component n-butyl (E)-7,9-decadienoate (E7,9-10:COOn-Bu) has made it possible to investigate communication disruption to control this lepidopteran pest. Conventional communication disruption trials showed marked decreases in the mean number of male moths captured in E7,9-10:COOnBu-treated fields compared with control fields. For traps baited with E7,9-10:COOnBu, percent disruptions were 94.4% and 92.1% for septa (1 g pheromone/ha, 1-wk trial duration) and spirals (6 g pheromone/ha, 8-wk trial duration) respectively. For traps baited with virgin female moths, percent disruption was 73.3% using septa disruptors (1 g pheromone/ha, 1-wk trial duration). Mobile communication disruption using Bactrocera cucurbitae (Coquillett) as carriers for E7,9-10:COOn-Bu was evaluated in the following three areas: fly survivorship, attraction of male moths to treated flies, and moth disruption in a small-scale field trial. Topical application of E7,9-10:COOnBu showed no significant decrease in survivorship at 50 and 80 µg/fly. However, decreased survivorship was observed at 100 µg/fly and linear regression showed E7,9-10:COOnBu dose was significantly correlated with B. cucurbitae survivorship. Traps containing honey–pheromone-fed flies attracted and caught D. pallivitta over a 1-wk period, demonstrating the attractiveness of the carrier. Releasing E7,9-10:COOnBu-fed B. cucurbitae (∼2 g pheromone/ha, 1-wk trial duration) resulted in significantly reduced trap catches in treatment fields compared with control fields on the first 2 d of the field trial. Percent disruptions were 84.7% (day 1) and 56.0% (day 2). These results suggest that both conventional communication disruption and mobile communication disruption have potential to control D. pallivitta. PMID:26078301

Disruption of Darna pallivitta (Lepidoptera: Limacodidae) by Conventional and Mobile Pheromone Deployment.

PubMed

Siderhurst, Matthew S; Jang, Eric B; Carvalho, Lori A F N; Nagata, Janice T; Derstine, Nathan T

2015-01-01

Identification of the Darna pallivitta (Moore) pheromone component n-butyl (E)-7,9-decadienoate (E7,9-10:COOn-Bu) has made it possible to investigate communication disruption to control this lepidopteran pest. Conventional communication disruption trials showed marked decreases in the mean number of male moths captured in E7,9-10:COOnBu-treated fields compared with control fields. For traps baited with E7,9-10:COOnBu, percent disruptions were 94.4% and 92.1% for septa (1 g pheromone/ha, 1-wk trial duration) and spirals (6 g pheromone/ha, 8-wk trial duration) respectively. For traps baited with virgin female moths, percent disruption was 73.3% using septa disruptors (1 g pheromone/ha, 1-wk trial duration). Mobile communication disruption using Bactrocera cucurbitae (Coquillett) as carriers for E7,9-10:COOn-Bu was evaluated in the following three areas: fly survivorship, attraction of male moths to treated flies, and moth disruption in a small-scale field trial. Topical application of E7,9-10:COOnBu showed no significant decrease in survivorship at 50 and 80 µg/fly. However, decreased survivorship was observed at 100 µg/fly and linear regression showed E7,9-10:COOnBu dose was significantly correlated with B. cucurbitae survivorship. Traps containing honey-pheromone-fed flies attracted and caught D. pallivitta over a 1-wk period, demonstrating the attractiveness of the carrier. Releasing E7,9-10:COOnBu-fed B. cucurbitae (∼2 g pheromone/ha, 1-wk trial duration) resulted in significantly reduced trap catches in treatment fields compared with control fields on the first 2 d of the field trial. Percent disruptions were 84.7% (day 1) and 56.0% (day 2). These results suggest that both conventional communication disruption and mobile communication disruption have potential to control D. pallivitta. © The Author 2015. Published by Oxford University Press on behalf of the Entomological Society of America.

NCTN/NCORP Data Archive: Expanding Access to Clinical Trial Data

Cancer.gov

NCI is launching the NCTN/NCORP Data Archive, a centralized repository of patient-level data from phase III clinical trials conducted by NCI’s NCTN and NCORP trials programs and the National Cancer Institute of Canada-Clinical Trials Group.

A randomized trial to evaluate the effectiveness of an individual, education-based safe transport program for drivers aged 75 years and older

PubMed Central

2013-01-01

Background There are concerns over safety of older drivers due to increased crash involvement and vulnerability to injury. However, loss of driving privileges can dramatically reduce independence and quality of life for older members of the community. The aim of this trial is to examine the effectiveness of a safe transport program for drivers aged 75 years and older at reducing driving exposure but maintaining mobility. Methods and design A randomised trial will be conducted, involving 380 drivers aged 75 years and older, resident in urban and semi-rural areas of North-West Sydney. The intervention is an education program based on the Knowledge Enhances Your Safety (KEYS) program, adapted for the Australian context. Driving experience will be measured objectively using an in-vehicle monitoring device which includes a global positioning system (GPS) to assess driving exposure and an accelerometer to detect rapid deceleration events. Participation will be assessed using the Keele Assessment of Participation (KAP). Data will be analysed on an intention-to-treat basis; the primary outcomes include driving exposure, rapid deceleration events and scores for KAP. Secondary outcomes include self-reported measures of driving, socialisation, uptake of alternative forms of transport, depressive symptoms and mood. A detailed process evaluation will be conducted, including examination of the delivery of the program and uptake of alternative forms of transport. A subgroup analysis is planned for drivers with reduced function as characterized by established cut-off scores on the Drivesafe assessment tool. Discussion This randomised trial is powered to provide an objective assessment of the efficacy of an individually tailored education and alternative transportation program to promote safety of older drivers but maintain mobility. Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12612000543886. PMID:23379593

Factors associated with failure of oncology drugs in late-stage clinical development: A systematic review.

PubMed

Jardim, Denis L; Groves, Eric S; Breitfeld, Philip P; Kurzrock, Razelle

2017-01-01

We aimed to describe the reasons for failure of experimental anticancer drugs in late-stage clinical development. We searched the PharmaProjects database (https://citeline.com/products/pharmaprojects/) for anticancer drugs discontinued between 01/01/2009 and 06/30/2014. Drug programs that reached phase III trials, but never gained Food and Drug Administration (FDA) approval were compared to 37 anti-cancer drugs achieving FDA approval in this time period. Forty-two drugs fit our criteria for development failures. These failed drugs (49% targeted, 23% cytotoxics, and 28% other) were tested in 43 cancer indications (drug programs). Only 16% (7/43) of failed drug programs adopted a biomarker-driven rationale for patient selection versus 57% (21/37) of successful drug programs (P<0.001). Phase II trial information was available in 32 of 43 failed drug programs and in 32 of 37 successful programs. Nine of the 32 trials (28%) of failed drugs versus 28 of 32 trials (87%) of successful drugs (P<0.001) achieved proof of concept (single agent response rate (RR) ⩾20% or combination therapy showing a ⩾20% RR increase above the median historical RR without the experimental agent (with a minimal absolute increase of 5%) or a randomized phase II trial showing significance (P⩽0.05) for its primary outcome). No pattern of study sites, trial design or funding characteristics emerged from the failed drug analysis. For drugs that reached Phase III, lack of a biomarker-driven strategy and failure to attain proof of concept in phase II are potential risk factors for later discontinuation, especially for targeted agents. Copyright © 2016 Elsevier Ltd. All rights reserved.

Microwave bale moisture sensing: Field trial

USDA-ARS?s Scientific Manuscript database

A microwave moisture measurement technique was developed for moisture sensing of cotton bales after the bale press. The technique measures the propagation delay of a microwave signal that is transmitted through the cotton bale. This research conducted a field trial to test the sensor in a commercial...

Linkages Among Agronomic, Environmental and Weed Management Characteristics in North American Sweet Corn

USDA-ARS?s Scientific Manuscript database

Performance of weed management systems varies greatly across the landscape in both growers’ fields and in experimental trials conducted by agricultural scientists. Using agronomic, environmental, and weed management information from growers’ fields and experimental trials, we identified dominant ch...

Field Trial of the Enhanced Data Authentication System (EDAS)

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

Thomas, Maikael A.; Baldwin, George T.; Hymel, Ross W.

2016-05-01

The goal of the field trial of EDAS was to demonstrate the utility of secure branching of operator instrumentation for nuclear safeguards, identify any unforeseen implementation and application issues with EDAS, and confirm whether the approach is compatible with operator concerns and constraints.

OPTIMIZATION OF DEEP DRILLING PERFORMANCE--DEVELOPMENT AND BENCHMARK TESTING OF ADVANCED DIAMOND PRODUCT DRILL BITS & HP/HT FLUIDS TO SIGNIFICANTLY IMPROVE RATES OF PENETRATION

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

Alan Black; Arnis Judzis

2004-10-01

The industry cost shared program aims to benchmark drilling rates of penetration in selected simulated deep formations and to significantly improve ROP through a team development of aggressive diamond product drill bit--fluid system technologies. Overall the objectives are as follows: Phase 1--Benchmark ''best in class'' diamond and other product drilling bits and fluids and develop concepts for a next level of deep drilling performance; Phase 2--Develop advanced smart bit-fluid prototypes and test at large scale; and Phase 3--Field trial smart bit-fluid concepts, modify as necessary and commercialize products. As of report date, TerraTek has concluded all major preparations for themore » high pressure drilling campaign. Baker Hughes encountered difficulties in providing additional pumping capacity before TerraTek's scheduled relocation to another facility, thus the program was delayed further to accommodate the full testing program.« less

Development of a chronic kidney disease patient navigator program.

PubMed

Jolly, Stacey E; Navaneethan, Sankar D; Schold, Jesse D; Arrigain, Susana; Konig, Victoria; Burrucker, Yvette K; Hyland, Jennifer; Dann, Priscilla; Tucky, Barbara H; Sharp, John W; Nally, Joseph V

2015-05-03

Chronic Kidney Disease (CKD) is a public health problem and there is a scarcity of type 2 CKD translational research that incorporates educational tools. Patient navigators have been shown to be effective at reducing disparities and improving outcomes in the oncology field. We describe the creation of a CKD Patient Navigator program designed to help coordinate care, address system-barriers, and educate/motivate patients. The conceptual framework for the CKD Patient Navigator Program is rooted in the Chronic Care Model that has a main goal of high-quality chronic disease management. Our established multidisciplinary CKD research team enlisted new members from information technology and data management to help create the program. It encompassed three phases: hiring, training, and implementation. For hiring, we wanted a non-medical or lay person with a college degree that possessed strong interpersonal skills and experience in a service-orientated field. For training, there were three key areas: general patient navigator training, CKD education, and electronic health record (EHR) training. For implementation, we defined barriers of care and created EHR templates for which pertinent study data could be extracted. We have hired two CKD patient navigators who will be responsible for navigating CKD patients enrolled in a clinical trial. They have undergone training in general patient navigation, specific CKD education through directed readings and clinical shadowing, as well as EHR and other patient related privacy and research training. The need for novel approaches like our CKD patient navigator program designed to impact CKD care is vital and should utilize team-based care and health information technology given the changing landscape of our health systems.

The Influence of User Characteristics and a Periodic Email Prompt on Exposure to an Internet-Delivered Computer-Tailored Lifestyle Program

PubMed Central

van Osch, Liesbeth; Schulz, Daniela N; Kremers, Stef PJ; de Vries, Hein

2012-01-01

Background The Internet is a promising medium in the field of health promotion for offering tailored and targeted lifestyle interventions applying computer-tailored (CT) techniques to the general public. Actual exposure to CT interventions is not living up to its high expectations, as only a (limited) proportion of the target group is actually using these programs. Objective To investigate exposure to an Internet-delivered, CT lifestyle intervention, targeting physical activity, fruit and vegetable intake, smoking behavior, and alcohol intake, we focused on three processes: first use, prolonged use, and sustained use. The first objectives were to identify user characteristics that predict initiation of an online CT lifestyle program (first use) and completion of this program (prolonged use). Furthermore, we studied the effect of using a proactive strategy, consisting of periodic email prompts, on program revisits (sustained use). Methods The research population for this study consisted of Dutch adults participating in the Adult Health Monitor, offered by the regional public health services. We used a randomized controlled trial design to assess predictors of first use, prolonged use, and sustained use. Demographics and behavioral characteristics, as well as the strategy used for revisiting, were included as predictors in the model. Results A total of 9169 participants indicated their interest in the new program and 5168 actually logged in to the program. Participants significantly more likely to initiate one of the CT modules were male, older, and employed, and had a lower income, higher body mass index, and relatively unhealthy lifestyle. Participants significantly more likely to complete one of the CT modules were older and had a higher income and a relatively healthier lifestyle. Finally, using a proactive strategy influenced sustained use, with people from the prompting condition being more likely to revisit the program (odds ratio 28.92, 95% confidence interval 10.65–78.52; P < .001). Conclusions Older, male, and employed participants, and those with a lower income, higher body mass index, and a relatively unhealthy lifestyle were more likely to initiate a CT module. Module completers predominantly had a higher income and age. The current program therefore succeeded in reaching those people who benefit most from online lifestyle interventions. However, these people tended to disengage from the program. This underlines the importance of additional research into program adjustments and strategies that can be used to stimulate prolonged program use. Furthermore, sending periodic email prompts significantly increased revisits to the program. Though promising, this effect was modest and needs to be further examined, in order to maximize the potential of periodic email prompting. Trial Registration Nederlands Trial Register (NTR: 1786) and Medical Ethics Committee of Maastricht University and the University Hospital Maastricht (NL2723506809/MEC0903016); http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1786 (Archived by WebCite at http://www.webcitation.org/65hBXA6V7) PMID:22382037

How sociodemographics, presence of oncology specialists, and hospital cancer programs affect accrual to cancer treatment trials.

PubMed

Sateren, Warren B; Trimble, Edward L; Abrams, Jeffrey; Brawley, Otis; Breen, Nancy; Ford, Leslie; McCabe, Mary; Kaplan, Richard; Smith, Malcolm; Ungerleider, Richard; Christian, Michaele C

2002-04-15

We chose to examine the impact of socioeconomic factors on accrual to National Cancer Institute (NCI)-sponsored cancer treatment trials. We estimated the geographic and demographic cancer burden in the United States and then identified 24,332 patients accrued to NCI-sponsored cancer treatment trials during a 12-month period. Next, we examined accrual by age, sex, geographic residence, health insurance status, health maintenance organization market penetration, several proxy measures of socioeconomic status, the availability of an oncologist, and the presence of a hospital with an approved multidisciplinary cancer program. Pediatric patients were accrued to clinical trials at high levels, whereas after adolescence, only a small percentage of cancer patients were enrolled onto clinical trials. There were few differences by sex. Black males as well as Asian-American and Hispanic adults were accrued to clinical trials at lower rates than white cancer patients of the same age. Overall, the highest observed accrual was in suburban counties. Compared with the United States population, patients enrolled onto clinical trials were significantly less likely to be uninsured and more like to have Medicare health insurance. Geographic areas with higher socioeconomic levels had higher levels of clinical trial accruals. The number of oncologists and the presence of approved cancer programs both were significantly associated with increased accrual to clinical trials. We must work to increase the number of adults who enroll onto trials, especially among the elderly. Ongoing partnership with professional societies may be an effective approach to strengthen accrual to clinical trials.

Can Targeted Intervention Mitigate Early Emotional and Behavioral Problems?: Generating Robust Evidence within Randomized Controlled Trials

PubMed Central

Doyle, Orla; McGlanaghy, Edel; O’Farrelly, Christine; Tremblay, Richard E.

2016-01-01

This study examined the impact of a targeted Irish early intervention program on children’s emotional and behavioral development using multiple methods to test the robustness of the results. Data on 164 Preparing for Life participants who were randomly assigned into an intervention group, involving home visits from pregnancy onwards, or a control group, was used to test the impact of the intervention on Child Behavior Checklist scores at 24-months. Using inverse probability weighting to account for differential attrition, permutation testing to address small sample size, and quantile regression to characterize the distributional impact of the intervention, we found that the few treatment effects were largely concentrated among boys most at risk of developing emotional and behavioral problems. The average treatment effect identified a 13% reduction in the likelihood of falling into the borderline clinical threshold for Total Problems. The interaction and subgroup analysis found that this main effect was driven by boys. The distributional analysis identified a 10-point reduction in the Externalizing Problems score for boys at the 90th percentile. No effects were observed for girls or for the continuous measures of Total, Internalizing, and Externalizing problems. These findings suggest that the impact of this prenatally commencing home visiting program may be limited to boys experiencing the most difficulties. Further adoption of the statistical methods applied here may help to improve the internal validity of randomized controlled trials and contribute to the field of evaluation science more generally. Trial Registration: ISRCTN Registry ISRCTN04631728 PMID:27253184

A randomized controlled trial on rehabilitation through caregiver-delivered nurse-organized service programs for disabled stroke patients in rural china (the RECOVER trial): design and rationale.

PubMed

Yan, Lijing L; Chen, Shu; Zhou, Bo; Zhang, Jing; Xie, Bin; Luo, Rong; Wang, Ninghua; Lindley, Richard; Zhang, Yuhong; Zhao, Yi; Li, Xian; Liu, Xiao; Peoples, Nicholas; Bettger, Janet Prvu; Anderson, Craig; Lamb, Sarah E; Wu, Yangfeng; Shi, Jingpu

2016-10-01

Stroke is the leading cause of death and disability in rural China. For stroke patients residing in resource-limited rural areas, secondary prevention and rehabilitation are largely unavailable, and where present, are far below evidence-based standards. This study aims to develop and implement a simplified stroke rehabilitation program that utilizes nurses and family caregivers for service delivery, and evaluate its feasibility and effectiveness in rural China. This 2-year randomized controlled trial is being conducted in 2-3 county hospitals located in northwest, northeast, and southwest China. Eligible and consenting stroke inpatients (200 in total) have been recruited and randomized into either a control or intervention group. Nurses in the county hospital are trained by rehabilitation specialists and in turn train the family caregivers in the intervention group. They also provide telephone follow-up care three times post discharge. The recruitment, baseline, intervention, follow-up care, and evaluation are guided by the RECOVER mobile phone app specifically designed for this study. The primary outcome is patients' Barthel Index (activities of daily living: mobility, self-care, and toileting) at 6 months. Process and economic evaluation will also be conducted. The results of our study will generate initial high-quality evidence to improve stroke care in resource-scarce settings. If proven effective, this innovative care delivery model has the potential to improve the health and function of stroke patients, relieve caregiver burden, guide policy-making, and advance translational research in the field of stroke care. © 2016 World Stroke Organization.

Strategies for More Rapid Translation of Cellular Therapies for Children: A US Perspective

PubMed Central

Silberstein, Leslie E.; Lindblad, Robert W.; Welniak, Lisbeth A.; Mondoro, Traci Heath; Wagner, John E.

2013-01-01

Clinical trials for pediatric diseases face many challenges, including trial design, accrual, ethical considerations for children as research subjects, and the cost of long-term follow-up studies. In September 2011, the Production Assistance for Cellular Therapies Program, funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health, sponsored a workshop, “Cell Therapy for Pediatric Diseases: A Growing Frontier,” with the overarching goal of optimizing the path of discovery in research involving novel cellular therapeutic interventions for debilitating pediatric conditions with few or no available treatment options. Academic and industry investigators in the fields of cellular therapy and regenerative medicine described the obstacles encountered in conducting a clinical trial from concept to conclusion. Patient and parent advocates, bioethicists, biostatisticians, regulatory representatives from the US Food and Drug Administration, and translational scientists actively participated in this workshop, seeking to identify the unmet needs specific to cellular therapies and treatment of pediatric diseases and propose strategies to facilitate the development of novel therapies. In this article we summarize the obstacles and potential corrective strategies identified by workshop participants to maximize the speed of cell therapy translational research for childhood diseases. PMID:23837178

Design strategy for a smoking cessation trial of survival.

PubMed

Shuster, Jonathan J

2015-04-01

Despite unequivocal evidence that smoking cessation is beneficial in terms of survival, there is at present no firm evidence that smoking cessation programs save lives. While they do increase quit rates, the collective evidence from randomized trials is inconclusive with respect to long-term survival. Withdrawal symptoms and the potential for harm when a subjects relapses after a prolonged period of cessation (e.g., 5+ years) might mitigate some or all of the benefits of the sustained quitters. This paper will review the key survival epidemiology and argue for a large randomized field trial of about 30,000 subjects, followed personally for 5 years and collectively for 15 years through the National Death Index. The intervention should be personalized, but reproducible through a treatment assignment algorithm. Personal coaching should be a major part of the intervention. Important short-term data on healthcare utilization should also be collected. Strong financial motivation for quitting (or prevention of smoking in the first place) is also presented. This paper is intended to motivate a large collective effort amongst the US Clinical and Translational Science Awardees to design the intervention and bring together the interested players to conduct the study. © 2013 Wiley Periodicals, Inc.

The "Healthy Habits, Healthy Girls" randomized controlled trial for girls: study design, protocol, and baseline results.

PubMed

Leme, Ana Carolina Barco; Philippi, Sonia Tucunduva

2015-07-01

The purpose of this article is to describe the study design, protocol, and baseline results of the "Healthy Habits, Healthy Girls" program. The intervention is being evaluated through a randomized controlled trial in 10 public schools in the city of São Paulo, Brazil. Data on the following variables were collected and assessed at baseline and will be reevaluated at 7 and 12 months: body mass index, waist circumference, dietary intake, nutrition, physical activity, social cognitive mediators, physical activity level, sedentary behaviors, self-rated physical status, and overall self-esteem. According to the baseline results, 32.4% and 23.4% of girls were overweight in the intervention and control groups, respectively, and in both groups a higher percentage failed to meet daily recommendations for moderate and vigorous physical activity and maximum screen time (TV, computer, mobile devices). There were no significant differences between the groups for most of the variables, except age (p = 0.000) and waist circumference (p = 0.014). The study showed a gap in the Brazilian literature on protocols for randomized controlled trials to prevent obesity among youth. The current study may thus be an important initial contribution to the field.

Quality control of involved field radiotherapy in the HD 13 and HD 14 trials : Report of the radiotherapy panel of the German Hodgkin Study Group (GHSG).

PubMed

Kriz, J; Baues, C; Engenhart-Cabillic, R; Haverkamp, U; Herfart, K; Lukas, P; Plütschow, A; Schmidberger, H; Staar, S; Fuchs, M; Engert, A; Eich, H T

2017-02-01

As part of the foundation of the German Hodgkin Study Group (GHSG) in 1978, a central radiotherapy (RT) reference centre was established to evaluate and to improve the quality of treatment. During the study generations, the quality assurance programs (QAP) were continued and adapted to the demands of each study. The purpose of this article is to demonstrate the results of the fifth study generation and to compare them to the previous findings. With the start of the fourth GHSG study generation (HD10-12), a central prospective review of all diagnostic images was established to create an individual treatment plan for each early stage study patient. The quality of involved field RT was retrospectively evaluated by an expert panel of radiation oncologists. In the fifth study generation (HD13-15), the retrospective review of radiotherapy performed was refined and the results were compared with the findings of the fourth generation. The expert panel analyzed the RT planning and application of 1037 (28 %) patients (HD13 n = 465, HD14 n = 572). Simulation films were available in 85 % of cases and verification films in 87 %. RT was assessed as major violation in 46 % (HD13 = 38 %, HD14 = 52 %), minor violation in 9 % (HD13 = 9 %, HD14 = 9 %) and according to the protocol in 45 % (HD13 = 52 %, HD14 = 38 %). The value for QAP of RT within the GHSG trials is well known. Still there were several protocol violations. In the future, the QAP program has to be adapted to the requirements of "modern RT" in malignant lymphoma.

Considering Culturally Relevant Parenting Practices in Intervention Development and Adaptation: A Randomized Controlled Trial of the Black Parenting Strengths and Strategies (BPSS) Program

ERIC Educational Resources Information Center

Coard, Stephanie I.; Foy-Watson, Shani; Zimmer, Catherine; Wallace, Amy

2007-01-01

A randomized prevention pilot trial compared caregivers who participated in the Black Parenting Strengths and Strategies (BPSS) Program with control caregivers. BPSS is a strengths- and culturally based parenting program designed to improve aspects of parenting associated with the early development of conduct problems and the promotion of social…

Individually Administered Problems. Third Grade. Evaluation Report 4-B-3. Extended Pilot Trial of the Comprehensive School Mathematics Program.

ERIC Educational Resources Information Center

Herbert, Martin

The Comprehensive School Mathematics Program (CSMP) is a program of CEMREL, Inc., one of the national educational laboratories, and was funded by the National Institute of Education (NIE). Its major purpose is the development of curriculum materials for the elementary grades. Beginning in 1973, CSMP ran an extended pilot trial of its elementary…

Individually Administered Problems. Fourth Grade. Evaluation Report 5-B-2. Extended Pilot Trial of the Comprehensive School Mathematics Program.

ERIC Educational Resources Information Center

Dougherty, Knowles; Herbert, Martin

The Comprehensive School Mathematics Program (CSMP) is a program of CEMREL, Inc., one of the national educational laboratories, and was funded by the National Institute of Education (NIE). Its major purpose is the development of curriculum materials for the elementary grades. Beginning in September 1973, CSMP ran an extended pilot trial of its…

Fourth Grade MANS Test Data. Evaluation Report 5-B-1. Extended Pilot Trial of the Comprehensive School Mathematics Program.

ERIC Educational Resources Information Center

Herbert, Martin

The Comprehensive School Mathematics Program (CSMP) is a program of CEMREL, Inc., one of the national educational laboratories, and was funded by the National Institute of Education (NIE). Its major purpose is the development of curriculum materials for the elementary grades. Beginning in 1973, CSMP ran an extended pilot trial of its elementary…

Ghosts in the Machine II: Neural Correlates of Memory Interference from the Previous Trial.

PubMed

Papadimitriou, Charalampos; White, Robert L; Snyder, Lawrence H

2017-04-01

Previous memoranda interfere with working memory. For example, spatial memories are biased toward locations memorized on the previous trial. We predicted, based on attractor network models of memory, that activity in the frontal eye fields (FEFs) encoding a previous target location can persist into the subsequent trial and that this ghost will then bias the readout of the current target. Contrary to this prediction, we find that FEF memory representations appear biased away from (not toward) the previous target location. The behavioral and neural data can be reconciled by a model in which receptive fields of memory neurons converge toward remembered locations, much as receptive fields converge toward attended locations. Convergence increases the resources available to encode the relevant memoranda and decreases overall error in the network, but the residual convergence from the previous trial can give rise to an attractive behavioral bias on the next trial. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Auxiliary-field-based trial wave functions in quantum Monte Carlo calculations

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

Chang, Chia -Chen; Rubenstein, Brenda M.; Morales, Miguel A.

2016-12-19

Quantum Monte Carlo (QMC) algorithms have long relied on Jastrow factors to incorporate dynamic correlation into trial wave functions. While Jastrow-type wave functions have been widely employed in real-space algorithms, they have seen limited use in second-quantized QMC methods, particularly in projection methods that involve a stochastic evolution of the wave function in imaginary time. Here we propose a scheme for generating Jastrow-type correlated trial wave functions for auxiliary-field QMC methods. The method is based on decoupling the two-body Jastrow into one-body projectors coupled to auxiliary fields, which then operate on a single determinant to produce a multideterminant trial wavemore » function. We demonstrate that intelligent sampling of the most significant determinants in this expansion can produce compact trial wave functions that reduce errors in the calculated energies. Lastly, our technique may be readily generalized to accommodate a wide range of two-body Jastrow factors and applied to a variety of model and chemical systems.« less

The Brazilian Cardioprotective Nutritional Program to reduce events and risk factors in secondary prevention for cardiovascular disease: study protocol (The BALANCE Program Trial).

PubMed

Weber, Bernardete; Bersch-Ferreira, Ângela Cristine; Torreglosa, Camila Ragne; Ross-Fernandes, Maria Beatriz; da Silva, Jacqueline Tereza; Galante, Andrea Polo; Lara, Enilda de Sousa; Costa, Rosana Perim; Soares, Rafael Marques; Cavalcanti, Alexandre Biasi; Moriguchi, Emilio H; Bruscato, Neide M; Kesties; Vivian, Lilian; Schumacher, Marina; de Carli, Waldemar; Backes, Luciano M; Reolão, Bruna R; Rodrigues, Milena P; Baldissera, Dúnnia M B; Tres, Glaucia S; Lisbôa, Hugo R K; Bem, João B J; Reolão, Jose B C; Deucher, Keyla L A L; Cantarelli, Maiara; Lucion, Aline; Rampazzo, Daniela; Bertoni, Vanessa; Torres, Rosileide S; Verríssimo, Adriana O L; Guterres, Aldair S; Cardos, Andrea F R; Coutinho, Dalva B S; Negrão, Mayara G; Alencar, Mônica F A; Pinho, Priscila M; Barbosa, Socorro N A A; Carvalho, Ana P P F; Taboada, Maria I S; Pereira, Sheila A; Heyde, Raul V; Nagano, Francisca E Z; Baumgartner, Rebecca; Resende, Fernanda P; Tabalipa, Ranata; Zanini, Ana C; Machado, Michael J R; Araujo, Hevila; Teixeira, Maria L V; Souza, Gabriela C; Zuchinali, Priccila; Fracasso, Bianca M; Ulliam, Karen; Schumacher, Marina; Pierotto, Moara; Hilário, Thamires; Carlos, Daniele M O; Cordeiro, Cintia G N C; Carvalho, Daniele A; Gonçalves, Marília S; Vasconcelos, Valdiana B; Bosquetti, Rosa; Pagano, Raira; Romano, Marcelo L P; Jardim, César A; de Abreu, Bernardo N A; Marcadenti, Aline; Schmitt, Alessandra R; Tavares, Angela M V; Faria, Christiane C; Silva, Flávia M; Fink, Jaqueline S; El Kik, Raquel M; Prates, Clarice F; Vieira, Cristiane S; Adorne, Elaine F; Magedanz, Ellen H; Chieza, Fernanda L; Silva, Ingrid S; Teixeira, Joise M; Trescastro, Eduardo P; Pellegrini, Lívia A; Pinto, Jéssika C; Telles, Cristina T; Sousa, Antonio C S; Almeida, Andreza S; Costa, Ariane A; Carmo, José A C; Silva, Juliana T; Alves, Luciana V S; Sales, Saulo O C; Ramos, Maria E M; Lucas, Marilia C S; Damiani, Monica; Cardoso, Patricia C; Ramos, Salvador S; Dantas, Clenise F; Lopes, Amanda G; Cabral, Ana M P; Lucena, Ana C A; Medeiros, Auriene L; Terceiro, Bernardino B; Leda, Neuma M F S; Baía, Sandra R D; Pinheiro, Josilene M F; Cassiano, Alexandra N; Melo, Andressa N L; Cavalcanti, Anny K O; Souza, Camila V S; Queiroz, Dayanna J M; Farias, Hercilla N C F; Souza, Larissa C F; Santos, Letícia S; Lima, Luana R M; Hoffmann, Meg S; Ribeiro, Átala S Silva; Vasconcelos, Daniel F; Dutra, Eliane S; Ito, Marina K; Neto, José A F; Santos, Alexsandro F; Sousa, Rosângela M L; Dias, Luciana Pereira P; Lima, Maria T M A; Modanesi, Victor G; Teixeira, Adriana F; Estrada, Luciana C N C D; Modanesi, Paulo V G; Gomes, Adriana B L; Rocha, Bárbara R S; Teti, Cristina; David, Marta M; Palácio, Bruna M; Junior, Délcio G S; Faria, Érica H S; Oliveira, Michelle C F; Uehara, Rose M; Sasso, Sandramara; Moreira, Annie S B; Cadinha, Ana C A H; Pinto, Carla W M; Castilhos, Mariana P; Costa, Mariana; Kovacs, Cristiane; Magnoni, Daniel; Silva, Quênia; Germini, Michele F C A; da Silva, Renata A; Monteiro, Aline S; dos Santos, Karina G; Moreira, Priscila; Amparo, Fernanda C; Paiva, Catharina C J; Poloni, Soraia; Russo, Diana S; Silveira, Izabele V; Moraes, Maria A; Boklis, Mirena; Cardoso, Quinto I; Moreira, Annie S B; Damaceno, Aline M S; Santos, Elisa M; Dias, Glauber M; Pinho, Cláudia P S; Cavalcanti, Adrilene C; Bezerra, Amanda S; Queiroga, Andrey V; Rodrigues, Isa G; Leal, Tallita V; Sahade, Viviane; Amaral, Daniele A; Souza, Diana S; Araújo, Givaldo A; Curvello, Karine; Heine, Manuella; Barretto, Marília M S; Reis, Nailson A; Vasconcelos, Sandra M L; Vieira, Danielly C; Costa, Francisco A; Fontes, Jessica M S; Neto, Juvenal G C; Navarro, Laís N P; Ferreira, Raphaela C; Marinho, Patrícia M; Abib, Renata Torres; Longo, Aline; Bertoldi, Eduardo G; Ferreira, Lauren S; Borges, Lúcia R; Azevedo, Norlai A; Martins, Celma M; Kato, Juliana T; Izar, Maria C O; Asoo, Marina T; de Capitani, Mariana D; Machado, Valéria A; Fonzar, Waléria T; Pinto, Sônia L; Silva, Kellen C; Gratão, Lúcia H A; Machado, Sheila D; de Oliveira, Susane R U; Bressan, Josefina; Caldas, Ana P S; Lima, Hatanne C F M; Hermsdorff, Helen H M; Saldanha, Tânia M; Priore, Sílvia E; Feres, Naoel H; Neves, Adila de Queiroz; Cheim, Loanda M G; Silva, Nilma F; Reis, Silvia R L; Penafort, Andreza M; de Queirós, Ana Paula O; Farias, Geysa M N; de los Santos, Mônica L P; Ambrozio, Cíntia L; Camejo, Cirília N; dos Santos, Cristiano P; Schirmann, Gabriela S; Boemo, Jorge L; Oliveira, Rosane E C; Lima, Súsi M B; Bortolini, Vera M S; Matos, Cristina H; Barretta, Claiza; Specht, Clarice M; de Souza, Simone R; Arruda, Cristina S; Rodrigues, Priscila A; Berwanger, Otávio

2016-01-01

This article reports the rationale for the Brazilian Cardioprotective Nutritional Program (BALANCE Program) Trial. This pragmatic, multicenter, nationwide, randomized, concealed, controlled trial was designed to investigate the effects of the BALANCE Program in reducing cardiovascular events. The BALANCE Program consists of a prescribed diet guided by nutritional content recommendations from Brazilian national guidelines using a unique nutritional education strategy, which includes suggestions of affordable foods. In addition, the Program focuses on intensive follow-up through one-on-one visits, group sessions, and phone calls. In this trial, participants 45 years or older with any evidence of established cardiovascular disease will be randomized to the BALANCE or control groups. Those in the BALANCE group will receive the afore mentioned program interventions, while controls will be given generic advice on how to follow a low-fat, low-energy, low-sodium, and low-cholesterol diet, with a view to achieving Brazilian nutritional guideline recommendations. The primary outcome is a composite of death (any cause), cardiac arrest, acute myocardial infarction, stroke, myocardial revascularization, amputation for peripheral arterial disease, or hospitalization for unstable angina. A total of 2468 patients will be enrolled in 34 sites and followed up for up to 48 months. If the BALANCE Program is found to decrease cardiovascular events and reduce risk factors, this may represent an advance in the care of patients with cardiovascular disease. Copyright © 2015 Elsevier Inc. All rights reserved.

Synthetic peptide vaccine against Taenia solium pig cysticercosis: successful vaccination in a controlled field trial in rural Mexico.

PubMed

Huerta, M; de Aluja, A S; Fragoso, G; Toledo, A; Villalobos, N; Hernández, M; Gevorkian, G; Acero, G; Díaz, A; Alvarez, I; Avila, R; Beltrán, C; Garcia, G; Martinez, J J; Larralde, C; Sciutto, E

2001-10-12

Taenia solium cysticercosis seriously affects human health when localised in the central nervous system (CNS) and causes great economic loss in pig husbandry in rural areas of endemic countries. Increasing the resistance to the parasite in the obligatory host pig may help in curbing transmission. Three synthetic peptides based on protein sequences of the murine parasite Taenia crassiceps, which had previously been shown to induce protection in mice against homologous challenge, were tested as a vaccine against T. solium cysticercosis in pigs. Vaccinated and unvaccinated piglets (240 in all) were distributed in pairs among the peasants' households of two rural villages in Mexico in which 14% of the native pigs were cysticercotic. Ten to twelve months later, the effect of vaccination was evaluated at necropsy. Vaccination decreased the total number of T. solium cysticerci (98.7%) and reduced the prevalence (52.6%). The natural challenge conditions used in this field trial strengthen the likelihood of successful transmission control to both pig and human through a large-scale pig vaccination program. We believe this is a major contribution in anticysticercosis vaccine development as these rather simple yet protective peptides are potentially more cost-effective to produce and less variable in results than antigens that are more complex.

Ticagrelor for the treatment of atherosclerotic disease: insights from the PARTHENON clinical development program.

PubMed

Held, Peter; Himmelmann, Anders; Ditmarsch, Marc

2016-07-01

Ticagrelor (P2Y12 receptor antagonist) is presently indicated for preventing atherothrombotic events in patients with acute coronary syndrome and patients with a history of myocardial infarction. The PARTHENON clinical development program comprises five randomized, controlled, cardiovascular, indication-seeking outcome studies, aiming to evaluate ticagrelor across the spectrum of patients with atherothrombotic disease. Results of two large-scale trials support a benefit for ticagrelor in patients with acute coronary syndrome (PLATO; ClinicalTrials.gov: NCT00391872) and in patients with a history of myocardial infarction (PEGASUS-TIMI 54; ClinicalTrials.gov: NCT01225562). Ongoing trials will provide information on the efficacy and safety of ticagrelor in patients with acute ischemic stroke or transient ischemic attack (SOCRATES; ClinicalTrials.gov: NCT01994720), peripheral artery disease (EUCLID; ClinicalTrials.gov: NCT01732822) and coronary artery disease in patients with Type 2 diabetes mellitus (THEMIS: ClinicalTrials.gov: NCT01991795).

Research design features and patient characteristics associated with the outcome of antidepressant clinical trials.

PubMed

Khan, Arif; Kolts, Russell L; Thase, Michael E; Krishnan, K Ranga Rama; Brown, Walter

2004-11-01

The authors examined which, if any, research design features and patient characteristics would significantly differ between successful and unsuccessful antidepressant trials. Clinical trial data were reviewed for nine antidepressants approved by the Food and Drug Administration between 1985 and 2000. From the antidepressant research programs on these medications, 52 clinical trials were included in the study. The authors evaluated trial design features, patient characteristics, and difference in response between placebo and antidepressant. Nine trial design features and patient characteristics were present in the research programs for all nine of the antidepressants. The severity of depressive symptoms before patient randomization, the dosing schedule (flexible versus fixed), the number of treatment arms, and the percentage of female patients were significantly associated with the difference in response to antidepressant and placebo. The duration of the antidepressant trial, number of patients per treatment arm, number of sites, and mean age of the patients were similar in successful trials (with a greater antidepressant-placebo difference) and less successful trials (with a smaller antidepressant-placebo difference). These findings may help in the design of future antidepressant trials.

Translation, cultural adaptation and field-testing of the Thinking Healthy Program for Vietnam

PubMed Central

2014-01-01

Background Depression and anxiety are prevalent among women in low- and lower-middle income countries who are pregnant or have recently given birth. There is promising evidence that culturally-adapted, evidence-informed, perinatal psycho-educational programs implemented in local communities are effective in reducing mental health problems. The Thinking Healthy Program (THP) has proved effective in Pakistan. The aims were to adapt the THP for rural Vietnam; establish the program’s comprehensibility, acceptability and salience for universal use, and investigate whether administration to small groups of women might be of equivalent effectiveness to administration in home visits to individual women. Methods The THP Handbook and Calendar were made available in English by the program developers and translated into Vietnamese. Cultural adaptation and field-testing were undertaken using WHO guidance. Field-testing of the four sessions of THP Module One was undertaken in weekly sessions with a small group in a rural commune and evaluated using baseline, process and endline surveys. Results The adapted Vietnamese version of the Thinking Healthy Program (THP-V) was found to be understandable, meaningful and relevant to pregnant women, and commune health centre and Women’s Union representatives in a rural district. It was delivered effectively by trained local facilitators. Role-play, brainstorming and small-group discussions to find shared solutions to common problems were appraised as helpful learning opportunities. Conclusions The THP-V is safe and comprehensible, acceptable and salient to pregnant women without mental health problems in rural Vietnam. Delivery in facilitated small groups provided valued opportunities for role-play rehearsal and shared problem solving. Local observers found the content and approach highly relevant to local needs and endorsed the approach as a mental health promotion strategy with potential for integration into local universal maternal and child health services. These preliminary data indicate that the impact of the THP-V should be tested in its complete form in a large scale trial. PMID:24886165

The Arecibo Observatory Space Academy

NASA Astrophysics Data System (ADS)

Rodriguez-Ford, Linda A.; Fernanda Zambrano Marin, Luisa; Aponte Hernandez, Betzaida; Soto, Sujeily; Rivera-Valentin, Edgard G.

2016-10-01

The Arecibo Observatory Space Academy (AOSA) is an intense fifteen-week pre-college research program for qualified high school students residing in Puerto Rico, which includes ten days for hands-on, on site research activities. Our mission is to prepare students for their professional careers by allowing them to receive an independent and collaborative research experience on topics related to the multidisciplinary field of space science. Our objectives are to (1) supplement the student's STEM education via inquiry-based learning and indirect teaching methods, (2) immerse students in an ESL environment, further developing their verbal and written presentation skills, and (3) foster in every student an interest in the STEM fields by harnessing their natural curiosity and knowledge in order to further develop their critical thinking and investigation skills. Students interested in participating in the program go through an application, interview and trial period before being offered admission. They are welcomed as candidates the first weeks, and later become cadets while experiencing designing, proposing, and conducting research projects focusing in fields like Physics, Astronomy, Geology, Chemistry, and Engineering. Each individual is evaluated with program compatibility based on peer interaction, preparation, participation, and contribution to class, group dynamics, attitude, challenges, and inquiry. This helps to ensure that specialized attention can be given to students who demonstrate a dedication and desire to learn. Deciding how to proceed in the face of setbacks and unexpected problems is central to the learning experience. At the end of the semester, students present their research to the program mentors, peers, and scientific staff. This year, AOSA students also focused on science communication and were trained by NASA's FameLab. Students additionally presented their research at this year's International Space Development Conference (ISDC), which was held in San Juan, Puerto Rico. Funding for this program is provided by NASA SSERVI-LPI: Center for Lunar Science and Exploration through USRA. Supplemental funding for attendance to ISDC was received from the Puerto Rico Science and Technology Trust.

Biochar: from laboratory mechanisms through the greenhouse to field trials

NASA Astrophysics Data System (ADS)

Masiello, C. A.; Gao, X.; Dugan, B.; Silberg, J. J.; Zygourakis, K.; Alvarez, P. J. J.

2014-12-01

The biochar community is excellent at pointing to individual cases where biochar amendment has changed soil properties, with some studies showing significant improvements in crop yields, reduction in nutrient export, and remediation of pollutants. However, many studies exist which do not show improvements, and in some cases, studies clearly show detrimental outcomes. The next, crucial step in biochar science and engineering research will be to develop a process-based understanding of how biochar acts to improve soil properties. In particular, we need a better mechanistic understanding of how biochar sorbs and desorbs contaminants, how it interacts with soil water, and how it interacts with the soil microbial community. These mechanistic studies need to encompass processes that range from the nanometer to the kilometer scale. At the nanometer scale, we need a predictive model of how biochar will sorb and desorb hydrocarbons, nutrients, and toxic metals. At the micrometer scale we need models that explain biochar's effects on soil water, especially the plant-available fraction of soil water. The micrometer scale is also where mechanistic information is neeed about microbial processes. At the macroscale we need physical models to describe the landscape mobility of biochar, because biochar that washes away from fields can no longer provide crop benefits. To be most informative, biochar research should occur along a lab-greenhouse-field trial trajectory. Laboratory experiments should aim determine what mechanisms may act to control biochar-soil processes, and then greenhouse experiments can be used to test the significance of lab-derived mechanisms in short, highly replicated, controlled experiments. Once evidence of effect is determined from greenhouse experiments, field trials are merited. Field trials are the gold standard needed prior to full deployment, but results from field trials cannot be extrapolated to other field sites without the mechanistic backup provided by greenhouse and lab trials.

7 CFR 1755.3 - Field trials.

Code of Federal Regulations, 2010 CFR

2010-01-01

... system electronics; (vi) Fiber optic cable system electronics; (vii) Multiplex equipment; (viii) Mobile... Telephone Systems of RUS Borrowers,” RUS Bulletin 344-2. When new items of materials or equipment are... that the field trial is carried out and that the required information on the product's performance is...

Trial application of reliability technology to emergency diesel generators at the Trojan Nuclear Power Plant

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

Wong, S.M.; Boccio, J.L.; Karimian, S.

1986-01-01

In this paper, a trial application of reliability technology to the emergency diesel generator system at the Trojan Nuclear Power Plant is presented. An approach for formulating a reliability program plan for this system is being developed. The trial application has shown that a reliability program process, using risk- and reliability-based techniques, can be interwoven into current plant operational activities to help in controlling, analyzing, and predicting faults that can challenge safety systems. With the cooperation of the utility, Portland General Electric Co., this reliability program can eventually be implemented at Trojan to track its effectiveness.

Extended Wearing Trial of Trifield Lens Device for “Tunnel Vision”

PubMed Central

Woods, Russell L.; Giorgi, Robert G.; Berson, Eliot L.; Peli, Eli

2009-01-01

Severe visual field constriction (tunnel vision) impairs the ability to navigate and walk safely. We evaluated Trifield glasses as a mobility rehabilitation device for tunnel vision in an extended wearing trial. Twelve patients with tunnel vision (5 to 22 degrees wide) due to retinitis pigmentosa or choroideremia participated in the 5-visit wearing trial. To expand the horizontal visual field, one spectacle lens was fitted with two apex-to-apex prisms that vertically bisected the pupil on primary gaze. This provides visual field expansion at the expense of visual confusion (two objects with the same visual direction). Patients were asked to wear these spectacles as much as possible for the duration of the wearing trial (median 8, range 6 to 60, weeks). Clinical success (continued wear, indicating perceived overall benefit), visual field expansion, perceived direction and perceived visual ability were measured. Of 12 patients, 9 chose to continue wearing the Trifield glasses at the end of the wearing trial. Of those 9 patients, at long-term follow-up (35 to 78 weeks), 3 reported still wearing the Trifield glasses. Visual field expansion (median 18, range 9 to 38, degrees) was demonstrated for all patients. No patient demonstrated adaptation to the change in visual direction produced by the Trifield glasses (prisms). For difficulty with obstacles, some differences between successful and non-successful wearers were found. Trifield glasses provided reported benefits in obstacle avoidance to 7 of the 12 patients completing the wearing trial. Crowded environments were particularly difficult for most wearers. Possible reasons for long-term discontinuation and lack of adaptation to perceived direction are discussed. PMID:20444130

Extended wearing trial of Trifield lens device for 'tunnel vision'.

PubMed

Woods, Russell L; Giorgi, Robert G; Berson, Eliot L; Peli, Eli

2010-05-01

Severe visual field constriction (tunnel vision) impairs the ability to navigate and walk safely. We evaluated Trifield glasses as a mobility rehabilitation device for tunnel vision in an extended wearing trial. Twelve patients with tunnel vision (5-22 degrees wide) due to retinitis pigmentosa or choroideremia participated in the 5-visit wearing trial. To expand the horizontal visual field, one spectacle lens was fitted with two apex-to-apex prisms that vertically bisected the pupil on primary gaze. This provides visual field expansion at the expense of visual confusion (two objects with the same visual direction). Patients were asked to wear these spectacles as much as possible for the duration of the wearing trial (median 8, range 6-60 weeks). Clinical success (continued wear, indicating perceived overall benefit), visual field expansion, perceived direction and perceived visual ability were measured. Of 12 patients, nine chose to continue wearing the Trifield glasses at the end of the wearing trial. Of those nine patients, at long-term follow-up (35-78 weeks), three reported still wearing the Trifield glasses. Visual field expansion (median 18, range 9-38 degrees) was demonstrated for all patients. No patient demonstrated adaptation to the change in visual direction produced by the Trifield glasses (prisms). For reported difficulty with obstacles, some differences between successful and non-successful wearers were found. Trifield glasses provided reported benefits in obstacle avoidance to 7 of the 12 patients completing the wearing trial. Crowded environments were particularly difficult for most wearers. Possible reasons for long-term discontinuation and lack of adaptation to perceived direction are discussed.

Estimating economic thresholds for site-specific weed control using manual weed counts and sensor technology: an example based on three winter wheat trials.

PubMed

Keller, Martina; Gutjahr, Christoph; Möhring, Jens; Weis, Martin; Sökefeld, Markus; Gerhards, Roland

2014-02-01

Precision experimental design uses the natural heterogeneity of agricultural fields and combines sensor technology with linear mixed models to estimate the effect of weeds, soil properties and herbicide on yield. These estimates can be used to derive economic thresholds. Three field trials are presented using the precision experimental design in winter wheat. Weed densities were determined by manual sampling and bi-spectral cameras, yield and soil properties were mapped. Galium aparine, other broad-leaved weeds and Alopecurus myosuroides reduced yield by 17.5, 1.2 and 12.4 kg ha(-1) plant(-1)  m(2) in one trial. The determined thresholds for site-specific weed control with independently applied herbicides were 4, 48 and 12 plants m(-2), respectively. Spring drought reduced yield effects of weeds considerably in one trial, since water became yield limiting. A negative herbicide effect on the crop was negligible, except in one trial, in which the herbicide mixture tended to reduce yield by 0.6 t ha(-1). Bi-spectral cameras for weed counting were of limited use and still need improvement. Nevertheless, large weed patches were correctly identified. The current paper presents a new approach to conducting field trials and deriving decision rules for weed control in farmers' fields. © 2013 Society of Chemical Industry.

77 FR 74625 - Policy To Encourage Trial Disclosure Programs; Information Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-17

... BUREAU OF CONSUMER FINANCIAL PROTECTION 12 CFR Chapter X [Docket No. CFPB-2012-0046] Policy To Encourage Trial Disclosure Programs; Information Collection AGENCY: Bureau of Consumer Financial Protection... Bureau of Consumer Financial Protection (Bureau) invites the general public and other Federal agencies to...

APPLICATION ANALYSIS REPORT - DEMONSTRATION OF A TRIAL EXCAVATION AT THE MCCOLL SUPERFUND SITE

EPA Science Inventory

In June 1990, the U.S. Environmental Protection Agency’s Region IX Superfund Program, in cooperation with EPA’s Air and Energy Engineering Research Laboratory (AEERL), and EPA’s Superfund Innovative Technology Evaluation (SITE) Program performed a trial excavation of approximatel...

Life Balance - a mindfulness-based mental health promotion program: conceptualization, implementation, compliance and user satisfaction in a field setting.

PubMed

Lyssenko, Lisa; Müller, Gerhard; Kleindienst, Nikolaus; Schmahl, Christian; Berger, Mathias; Eifert, Georg; Kölle, Alexander; Nesch, Siegmar; Ommer-Hohl, Jutta; Wenner, Michael; Bohus, Martin

2015-08-01

Mental health disorders account for a large percentage of the total burden of illness and constitute a major economic challenge in industrialized countries. Several prevention programs targeted at high-risk or sub-clinical populations have been shown to decrease risk, to increase quality of life, and to be cost-efficient. However, there is a paucity of primary preventive programs aimed at the general adult population. "Life Balance" is a program that employs strategies borrowed from well-established psychotherapeutic approaches, and has been made available to the public in one federal German state by a large health care insurance company. The data presented here are the preliminary findings of an ongoing field trial examining the outcomes of the Life Balance program with regard to emotional distress, life satisfaction, resilience, and public health costs, using a matched control group design. Life Balance courses are held at local health-care centers, in groups of 12 to 15 which are led by laypeople who have been trained on the course materials. Participants receive instruction on mindfulness and metacognitive awareness, and are assigned exercises to practice at home. Over an 8-month period in 2013-2014, all individuals who signed up for the program were invited at the time of enrollment to take part in a study involving the provision of psychometric data and of feedback on the course. A control group of subjects was invited to complete the questionnaires on psychometric data but did not receive any intervention. Of 4,898 adults who attended Life Balance courses over the specified period, 1,813 (37.0 %) provided evaluable study data. The average age of study participants was 49.5 years, and 83 % were female. At baseline, participants' self-reported symptoms of depression and anxiety, life satisfaction, and resilience were significantly higher than those seen in the general German population. Overall, evaluations of the course were positive, and 83 % of participants attended at least at 6 of the 7 sessions. Some sociodemographic correlations were noted: men carried out the assigned exercises less often than did women, and younger participants practiced mindfulness less frequently than did older ones. However, satisfaction and compliance with the program were similar across all sociodemographic categories. While the Life Balance program is publicized as a primary prevention course that is not directed at a patient population, the data indicate that it was utilized by people with a significant mental health burden, and that the concept can be generalized to a broad population. As data from the control group are not yet available, conclusions about effectiveness cannot yet be drawn. German Clinical Trials Registration ID: DRKS00006216.

Housing First: exploring participants’ early support needs

PubMed Central

2014-01-01

Background Housing First has become a popular treatment model for homeless adults with mental illness, yet little is known about program participants’ early experiences or trajectories. This study used a mixed methods design to examine participant changes in selected domains 6 months after enrolment in a Canadian field trial of Housing First. Methods The study sample included 301 participants receiving the Housing First intervention at the Toronto site of the At Home/Chez Soi project. This study used a pre-post design to compare quantitative 6-month outcome data to baseline values in key domains and multivariate regression to identify baseline demographic, clinical or service use variables associated with observed changes in these domains. In addition, qualitative data exploring participant and service provider perspectives and experiences was collected via stakeholder interviews and focus groups, and analyzed using thematic analysis. Results The majority (60 to 72%) of participants followed the expected trajectory of improvement, with the remaining experiencing difficulties in community integration, mental health symptom severity, substance use, community functioning and quality of life 6 months after program enrolment. Diagnosis of psychotic disorder was associated with a reduction in quality of life from baseline to 6-months, while substance use disorders were associated with reduced mental illness symptoms and substance use related problems and an improvement in quality of life. Participants housed in independent housing at 6-months had greater improvements in community integration and quality of life, and greater reduction in mental illness symptoms, compared to those not independently housed. The quality of the working alliance was positively associated with improvements in physical and psychological community integration and quality of life. Qualitative data provided a unique window into the loneliness and isolation experienced by Housing First participants, as well as problems related to substance use and a need for life skills training and support. Conclusions Additional strategies can help support Housing First participants in the early stages of program participation and address potential causes of early difficulties, including lack of life skills and social isolation. This study highlights the importance of early and ongoing evaluation, monitoring and program adaptations to address consumer support needs. Trial registration Current Controlled Trials ISRCTN42520374 PMID:24725374

Yoga and exercise for symptoms of depression and anxiety in people with poststroke disability: a randomized, controlled pilot trial.

PubMed

Chan, Weili; Immink, Maarten A; Hillier, Susan

2012-01-01

Mood disorders are prevalent in people after stroke, and a disorder's onset can exacerbate stroke-related disabilities. While evidence supports the mental-health benefits of participation in exercise and yoga, it is unknown whether such benefits extend to a population with poststroke hemiparesis. The study investigated whether supplementing exercise with participation in a yoga program would provide further improvements in self-reported symptoms of depression and anxiety in a chronic poststroke population, and it also assessed trial feasibility for future studies. The research team designed a randomized, controlled pilot trial that included an exercise-only group (EX, control) and a yoga-and-exercise group (YEX, intervention). The study took place at the Centre for Physical Activity in Ageing an exercise rehabilitation and activity center at the Royal Adelaide Hospital in South Australia. The participants included 14 individuals with chronic poststroke hemiparesis: eight in the intervention group and six in the control group. The YEX group participated in a 6-week standardized program that included yoga in weekly group sessions and home practice in addition to exercise in a weekly group class. The EX group participated only in the group exercise class weekly for 6 weeks. The research team assessed self-reported symptoms of depression using the Geriatric Depression Scale (GDS15) and symptoms of anxiety and negative affect using the State Trait Anxiety Inventory (STAI). The team based the feasibility evaluation on recruitment outcomes, retention of participants, participants' compliance with the intervention program, and the safety of the intervention. Changes in depression and state and trait anxiety did not significantly differ between intervention groups (GDS15 P=.749, STAI-Y1, P=.595, STAI-Y2, P=.407). Comparison of individuals' case results indicated clinically relevant improvements in both groups, although members of the intervention group had greater improvements. Participants reported no adverse events, and the study experienced high retention of participants and high compliance in the yoga program. This pilot study provides preliminary data on the effects of yoga combined with exercise to influence mood poststroke. It is a feasible, safe, and acceptable intervention, and the field requires additional investigations with a larger sample size.

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…

EVALUATION OF THE AGDISP AERIAL SPRAY ALGORITHMS IN THE AGDRIFT MODEL

EPA Science Inventory

A systematic evaluation of the AgDISP algorithms, which simulate off-site drift and deposition of aerially applied pesticides, contained in the AgDRIFT model was performed by comparing model simulations to field-trial data collected by the Spray Drift Task Force. Field-trial data...

Supporting Non-School Leaver Students in Their First Year of University Study: Results of a Transition Focused Peer-to-Peer Intensive Mentoring Program Trial

ERIC Educational Resources Information Center

Larkin, Ashleigh; Dwyer, Angela

2016-01-01

This paper discusses the results of an intensive mentoring program trial designed to address retention issues with first year students in Justice degrees. The purpose of the program was to reduce student attrition, specifically for non-school leaver Justice students, by creating a culture of student cooperation and support. In line with previous…

Mathematics Applied to Novel Situations (MANS) Test Data. Third Grade. Evaluation Report 4-B-2. Extended Pilot Trial of the Comprehensive School Mathematics Program.

ERIC Educational Resources Information Center

Dougherty, Knowles; Herbert, Martin

The Comprehensive School Mathematics Program (CSMP) is a program of CEMREL, Inc., one of the national educational laboratories, and was funded by the National Institute of Education (NIE). Its major purpose is the development of curriculum materials for the elementary grades. Beginning in 1973, CSMP ran an extended pilot trial of its elementary…

A generic minimization random allocation and blinding system on web.

PubMed

Cai, Hongwei; Xia, Jielai; Xu, Dezhong; Gao, Donghuai; Yan, Yongping

2006-12-01

Minimization is a dynamic randomization method for clinical trials. Although recommended by many researchers, the utilization of minimization has been seldom reported in randomized trials mainly because of the controversy surrounding the validity of conventional analyses and its complexity in implementation. However, both the statistical and clinical validity of minimization were demonstrated in recent studies. Minimization random allocation system integrated with blinding function that could facilitate the implementation of this method in general clinical trials has not been reported. SYSTEM OVERVIEW: The system is a web-based random allocation system using Pocock and Simon minimization method. It also supports multiple treatment arms within a trial, multiple simultaneous trials, and blinding without further programming. This system was constructed with generic database schema design method, Pocock and Simon minimization method and blinding method. It was coded with Microsoft Visual Basic and Active Server Pages (ASP) programming languages. And all dataset were managed with a Microsoft SQL Server database. Some critical programming codes were also provided. SIMULATIONS AND RESULTS: Two clinical trials were simulated simultaneously to test the system's applicability. Not only balanced groups but also blinded allocation results were achieved in both trials. Practical considerations for minimization method, the benefits, general applicability and drawbacks of the technique implemented in this system are discussed. Promising features of the proposed system are also summarized.

Physical activity programs for promoting bone mineralization and growth in preterm infants.

PubMed

Schulzke, Sven M; Kaempfen, Siree; Trachsel, Daniel; Patole, Sanjay K

2014-04-22

Lack of physical stimulation may contribute to metabolic bone disease of preterm infants, resulting in poor bone mineralization and growth. Physical activity programs combined with adequate nutrition might help to promote bone mineralization and growth. The primary objective was to assess whether physical activity programs in preterm infants improve bone mineralization and growth and reduce the risk of fracture.The secondary objectives included other potential benefits in terms of length of hospital stay, skeletal deformities and neurodevelopmental outcomes, and adverse events.Subgroup analysis:• Given that the smallest infants are most vulnerable for developing osteopenia (Bishop 1999), a subgroup analysis was planned for infants with birth weight < 1000 g.• Calcium and phosphorus intake may affect an infant's ability to increase bone mineral content (Kuschel 2004). Therefore, an additional subgroup analysis was planned for infants receiving different amounts of calcium and phosphorus, along with full enteral feeds as follows. ∘ Below 100 mg/60 mg calcium/phosphorus or equal to/above 100 mg/60 mg calcium/phosphorus per 100 mL milk. ∘ Supplementation of calcium without phosphorus. ∘ Supplementation of phosphorus without calcium. The standard search strategy of the Cochrane Neonatal Review Group (CNRG) was used. The search included the Cochrane Central Register of Controlled Trials (CENTRAL) (2012, Issue 9), MEDLINE, EMBASE, CINAHL (1966 to March 2013), and cross-references, as well as handsearching of abstracts of the Society for Pediatric Research and the International Journal of Sports Medicine. Randomized and quasi-randomized controlled trials comparing physical activity programs (extension and flexion, range-of-motion exercises) versus no organized physical activity programs in preterm infants. Data collection, study selection, and data analysis were performed according to the methods of the CNRG. Eleven trials enrolling 324 preterm infants (gestational age 26 to 34 weeks) were included in this review. All were small (N = 16 to 50) single-center studies that evaluated daily physical activity for three and one-half to eight weeks during initial hospitalization. Methodological quality and reporting of included trials were variable.Four trials demonstrated moderate short-term benefits of physical activity for bone mineralization at completion of the physical activity program. The only trial assessing long-term effects on bone mineralization showed no effect of physical activity administered during initial hospitalization on bone mineralization at 12 months corrected age. Meta-analysis from four trials demonstrated a positive effect of physical activity on daily weight gain (weighted mean difference (WMD) 2.21 g/kg/d, 95% confidence interval (CI) 1.23 to 3.19). Data from four trials showed a positive effect on linear growth (WMD 0.12 cm/wk, 95% CI 0.01 to 0.24) but not on head growth (WMD -0.03 cm/wk, 95% CI -0.14 to 0.08) during the study period. Only one trial reported on fractures (this outcome did not occur in intervention and control groups) and complications of preterm birth (no significant differences between intervention and control groups). None of the trials assessed other outcomes relevant to this review. Some evidence suggests that physical activity programs might promote short-term weight gain and bone mineralization in preterm infants. Data are inadequate to allow assessment of harm or long-term effects. Current evidence does not support the routine use of physical activity programs in preterm infants. Further trials incorporating infants with a high baseline risk of osteopenia are required. These trials should address adverse events, long-term outcomes, and the effects of nutritional intake (calories, protein, calcium, phosphorus).

Computer-Assisted Learning in Elementary Reading: A Randomized Control Trial

ERIC Educational Resources Information Center

Shannon, Lisa Cassidy; Styers, Mary Koenig; Wilkerson, Stephanie Baird; Peery, Elizabeth

2015-01-01

This study evaluated the efficacy of Accelerated Reader, a computer-based learning program, at improving student reading. Accelerated Reader is a progress-monitoring, assessment, and practice tool that supports classroom instruction and guides independent reading. Researchers used a randomized controlled trial to evaluate the program with 344…

Impact of an Educational Program to Reduce Healthcare Resources in Community-Acquired Pneumonia: The EDUCAP Randomized Controlled Trial

PubMed Central

Simonetti, Antonella; Jiménez-Martínez, Emilio; Molero, Lorena; González-Samartino, Maribel; Castillo, Elena; Juvé-Udina, María-Eulalia; Alcocer, María-Jesús; Hernández, Carme; Buera, María-Pilar; Roel, Asunción; Abad, Emilia; Zabalegui, Adelaida; Ricart, Pilar; Gonzalez, Anna; Isla, Pilar; Dorca, Jordi; Garcia-Vidal, Carolina

2015-01-01

Background Additional healthcare visits and rehospitalizations after discharge are frequent among patients with community-acquired pneumonia (CAP) and have a major impact on healthcare costs. We aimed to determine whether the implementation of an individualized educational program for hospitalized patients with CAP would decrease subsequent healthcare visits and readmissions within 30 days of hospital discharge. Methods A multicenter, randomized trial was conducted from January 1, 2011 to October 31, 2014 at three hospitals in Spain. We randomly allocated immunocompetent adults patients hospitalized for CAP to receive either an individualized educational program or conventional information before discharge. The educational program included recommendations regarding fluid intake, adherence to drug therapy and preventive vaccines, knowledge and management of the disease, progressive adaptive physical activity, and counseling for alcohol and smoking cessation. The primary trial endpoint was a composite of the frequency of additional healthcare visits and rehospitalizations within 30 days of hospital discharge. Intention-to-treat analysis was performed. Results We assigned 102 patients to receive the individualized educational program and 105 to receive conventional information. The frequency of the composite primary end point was 23.5% following the individualized program and 42.9% following the conventional information (difference, -19.4%; 95% confidence interval, -6.5% to -31.2%; P = 0.003). Conclusions The implementation of an individualized educational program for hospitalized patients with CAP was effective in reducing subsequent healthcare visits and rehospitalizations within 30 days of discharge. Such a strategy may help optimize available healthcare resources and identify post-acute care needs in patients with CAP. Trial Registration Controlled-Trials.com ISRCTN39531840 PMID:26460907

Selection of nontarget arthropod taxa for field research on transgenic insecticidal crops: using empirical data and statistical power.

PubMed

Prasifka, J R; Hellmich, R L; Dively, G P; Higgins, L S; Dixon, P M; Duan, J J

2008-02-01

One of the possible adverse effects of transgenic insecticidal crops is the unintended decline in the abundance of nontarget arthropods. Field trials designed to evaluate potential nontarget effects can be more complex than expected because decisions to conduct field trials and the selection of taxa to include are not always guided by the results of laboratory tests. Also, recent studies emphasize the potential for indirect effects (adverse impacts to nontarget arthropods without feeding directly on plant tissues), which are difficult to predict because of interactions among nontarget arthropods, target pests, and transgenic crops. As a consequence, field studies may attempt to monitor expansive lists of arthropod taxa, making the design of such broad studies more difficult and reducing the likelihood of detecting any negative effects that might be present. To improve the taxonomic focus and statistical rigor of future studies, existing field data and corresponding power analysis may provide useful guidance. Analysis of control data from several nontarget field trials using repeated-measures designs suggests that while detection of small effects may require considerable increases in replication, there are taxa from different ecological roles that are sampled effectively using standard methods. The use of statistical power to guide selection of taxa for nontarget trials reflects scientists' inability to predict the complex interactions among arthropod taxa, particularly when laboratory trials fail to provide guidance on which groups are more likely to be affected. However, scientists still may exercise judgment, including taxa that are not included in or supported by power analyses.

Application of Biomarkers in the Development of Drugs Intended for the Treatment of Osteoarthritis

PubMed Central

Kraus, Virginia Byers; Burnett, Bruce; Coindreau, Javier; Cottrell, Susan; Eyre, David; Gendreau, Michael; Gardiner, Jennifer; Garnero, Patrick; Hardin, John; Henrotin, Yves; Heinegård, Dick; Ko, Amy; Lohmander, Stefan; Matthews, Gloria; Menetski, Joseph; Moskowitz, Roland; Persiani, Stefano; Poole, Robin; Rousseau, Jean Charles; Todman, Martin

2013-01-01

Objective Osteoarthritis (OA) is a chronic and slowly progressive disease for which biomarkers may be able to provide a more rapid indication of therapeutic responses to therapy than is currently available; this could accelerate and facilitate OA drug discovery and development programs. The goal of this document is to provide a summary and guide to the application of in vitro (biochemical and other soluble) biomarkers in the development of drugs for OA and to outline and stimulate a research agenda that will further this goal. Methods The Biomarkers Working Group representing experts in the field of OA biomarker research from both academia and industry developed this consensus document between 2007–2009 at the behest of the Osteoarthritis Research Society International (OARSI FDA initiative). Results This document summarizes definitions and classification systems for biomarkers, the current outcome measures used in OA clinical trials, applications and potential utility of biomarkers for development of OA therapeutics, the current state of qualification of OA-related biomarkers, pathways for biomarker qualification, critical needs to advance the use of biomarkers for drug development, recommendations regarding practices and clinical trials, and a research agenda to advance the science of OA-related biomarkers. Conclusions Although many OA-related biomarkers are currently available they exist in various states of qualification and validation. The biomarkers that are likely to have the earliest beneficial impact on clinical trials fall into two general categories, those that will allow targeting of subjects most likely to either respond and/or progress (prognostic value) within a reasonable and manageable time frame for a clinical study (for instance within one to two years for an OA trial), and those that provide early feedback for preclinical decision-making and for trial organizers that a drug is having the desired biochemical effect. As in vitro biomarkers are increasingly investigated in the context of specific drug treatments, advances in the field can be expected that will lead to rapid expansion of the list of available biomarkers with increasing understanding of the molecular processes that they represent. PMID:21396468

Field evaluation of an engineering control for respirable crystalline silica exposures during mortar removal.

PubMed

Collingwood, Scott; Heitbrink, William A

2007-11-01

During mortar removal with a right angle grinder, a building renovation process known as "tuck pointing," worker exposures to respirable crystalline silica can be as high as 5 mg/m(3), 100 times the recommended exposure limit developed by the National Institute for Occupational Safety and Health. To reduce the risk of silicosis among these workers, a vacuum cleaner can be used to exhaust 80 ft(3)/min (2.26 m(3)/min) from a hood mounted on the grinder. Field trials examined the ability of vacuum cleaners to maintain adequate exhaust ventilation rates and measure exposure outcomes when using this engineering control. These field trials involved task-based exposure measurement of respirable dust and crystalline silica exposures during mortar removal. These measurements were compared with published exposure data. Vacuum cleaner airflows were obtained by measuring and digitally logging vacuum cleaner static pressure at the inlet to the vacuum cleaner motor. Static pressures were converted to airflows based on experimentally determined fan curves. In two cases, video exposure monitoring was conducted to study the relationship between worker activities and dust exposure. Worker activities were video taped concurrent with aerosol photometer measurement of dust exposure and vacuum cleaner static pressure as a measure of airflow. During these field trials, respirable crystalline silica exposures for 22 samples had a geometric mean of 0.06 mg/m(3) and a range of less than 0.01 to 0.86 mg/m(3). For three other studies, respirable crystalline silica exposures during mortar removal have a geometric means of 1.1 to 0.35. Although this field study documented noticeably less exposure to crystalline silica, video exposure monitoring found that the local exhaust ventilation provided incomplete dust control due to low exhaust flow rates, certain work practices, and missing mortar. Vacuum cleaner airflow decrease had a range of 3 to 0.4 ft(3)/min (0.08 to 0.01 m(3)/sec(2)) over a range of vacuum cleaners, hose diameters, and hose lengths. To control worker exposure to respirable crystalline silica, local exhaust ventilation needs to be incorporated into a comprehensive silica control program that includes respiratory protection, worker training, and local exhaust ventilation.

Protection of data carriers using secure optical codes

NASA Astrophysics Data System (ADS)

Peters, John A.; Schilling, Andreas; Staub, René; Tompkin, Wayne R.

2006-02-01

Smartcard technologies, combined with biometric-enabled access control systems, are required for many high-security government ID card programs. However, recent field trials with some of the most secure biometric systems have indicated that smartcards are still vulnerable to well equipped and highly motivated counterfeiters. In this paper, we present the Kinegram Secure Memory Technology which not only provides a first-level visual verification procedure, but also reinforces the existing chip-based security measures. This security concept involves the use of securely-coded data (stored in an optically variable device) which communicates with the encoded hashed information stored in the chip memory via a smartcard reader device.

NCI National Clinical Trials Network Structure

Cancer.gov

Learn about how the National Clinical Trials Network (NCTN) is structured. The NCTN is a program of the National Cancer Institute that gives funds and other support to cancer research organizations to conduct cancer clinical trials.

Financial Burden of Cancer Clinical Trial Participation and the Impact of a Cancer Care Equity Program

PubMed Central

Lee, Hang; Powell, Elizabeth; Birrer, Nicole E.; Poles, Emily; Finkelstein, Daniel; Winkfield, Karen; Percac-Lima, Sanja; Chabner, Bruce; Moy, Beverly

2016-01-01

Introduction. Cancer clinical trial (CT) participation rates are low and financial barriers likely play a role. We implemented a cancer care equity program (CCEP) to address financial burden associated with trial participation. We sought to examine the impact of the CCEP on CT enrollment and to assess barriers to participation. Methods. We used an interrupted time series design to determine trends in CT enrollment before and after CCEP implementation. Linear regression models compared trial enrollment before and after the CCEP. We also compared patient characteristics before and after the CCEP and between CCEP and non-CCEP participants. We surveyed CCEP and non-CCEP participants to compare pre-enrollment financial barriers. Results. After accounting for increased trial availability and the trends in accrual for prior years, we found that enrollment increased after CCEP implementation (18.97 participants per month greater than expected; p < .001). A greater proportion of CCEP participants were younger, female, in phase I trials, lived farther away, had lower incomes, and had metastatic disease. Of 87 participants who completed the financial barriers survey, 49 CCEP and 38 matched, non-CCEP participants responded (63% response rate). CCEP participants were more likely to report concerns regarding finances (56% vs. 11%), medical costs (47% vs. 14%), travel (69% vs. 11%), lodging (60% vs. 9%), and insurance coverage (43% vs. 14%) related to trial participation (all p < .01). Conclusion. CT participation increased following implementation of the CCEP and the program enrolled patients experiencing greater financial burden. These findings highlight the need to address the financial burden associated with CT participation. Implications for Practice: Financial barriers likely discourage patients from participating in clinical trials. Implementation of a cancer care equity program (CCEP) seeking to reduce financial barriers by assisting with travel and lodging costs was associated with increased trial accrual. The CCEP provided assistance to patients particularly in need, including those living farther away, those with lower incomes, and those reporting financial barriers related to trial participation. These findings suggest that financial concerns represent a major barrier to patient participation in clinical trials and underscore the importance of efforts to address these concerns. PMID:26975867

Financial Burden of Cancer Clinical Trial Participation and the Impact of a Cancer Care Equity Program.

PubMed

Nipp, Ryan D; Lee, Hang; Powell, Elizabeth; Birrer, Nicole E; Poles, Emily; Finkelstein, Daniel; Winkfield, Karen; Percac-Lima, Sanja; Chabner, Bruce; Moy, Beverly

2016-04-01

Cancer clinical trial (CT) participation rates are low and financial barriers likely play a role. We implemented a cancer care equity program (CCEP) to address financial burden associated with trial participation. We sought to examine the impact of the CCEP on CT enrollment and to assess barriers to participation. We used an interrupted time series design to determine trends in CT enrollment before and after CCEP implementation. Linear regression models compared trial enrollment before and after the CCEP. We also compared patient characteristics before and after the CCEP and between CCEP and non-CCEP participants. We surveyed CCEP and non-CCEP participants to compare pre-enrollment financial barriers. After accounting for increased trial availability and the trends in accrual for prior years, we found that enrollment increased after CCEP implementation (18.97 participants per month greater than expected; p < .001). A greater proportion of CCEP participants were younger, female, in phase I trials, lived farther away, had lower incomes, and had metastatic disease. Of 87 participants who completed the financial barriers survey, 49 CCEP and 38 matched, non-CCEP participants responded (63% response rate). CCEP participants were more likely to report concerns regarding finances (56% vs. 11%), medical costs (47% vs. 14%), travel (69% vs. 11%), lodging (60% vs. 9%), and insurance coverage (43% vs. 14%) related to trial participation (all p < .01). CT participation increased following implementation of the CCEP and the program enrolled patients experiencing greater financial burden. These findings highlight the need to address the financial burden associated with CT participation. Financial barriers likely discourage patients from participating in clinical trials. Implementation of a cancer care equity program (CCEP) seeking to reduce financial barriers by assisting with travel and lodging costs was associated with increased trial accrual. The CCEP provided assistance to patients particularly in need, including those living farther away, those with lower incomes, and those reporting financial barriers related to trial participation. These findings suggest that financial concerns represent a major barrier to patient participation in clinical trials and underscore the importance of efforts to address these concerns. ©AlphaMed Press.

Children’s Healthy Living (CHL) Program for remote underserved minority populations in the Pacific region: rationale and design of a community randomized trial to prevent early childhood obesity

PubMed Central

2013-01-01

Background Although surveillance data are limited in the US Affiliated Pacific, Alaska, and Hawaii, existing data suggest that the prevalence of childhood obesity is similar to or in excess of other minority groups in the contiguous US. Strategies for addressing the childhood obesity epidemic in the region support the use of community-based, environmentally targeted interventions. The Children’s Healthy Living Program is a partnership formed across institutions in the US Affiliated Pacific, Alaska, and Hawaii to design a community randomized environmental intervention trial and a prevalence survey to address childhood obesity in the region through affecting the food and physical activity environment. Methods/Design The Children’s Healthy Living Program community randomized trial is an environmental intervention trial in four matched-pair communities in American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, and Hawaii and two matched-pair communities in Alaska. A cross-sectional sample of children (goal n = 180) in each of the intervention trial communities is being assessed for outcomes at baseline and at 24 months (18 months post-intervention). In addition to the collection of the participant-based measures of anthropometry, diet, physical activity, sleep and acanthosis nigricans, community assessments are also being conducted in intervention trial communities. The Freely Associated States of Micronesia (Federated States of Micronesia, and Republics of Marshall Islands and Palau) is only conducting elements of the Children’s Healthy Living Program sampling framework and similar measurements to provide prevalence data. In addition, anthropometry information will be collected for two additional communities in each of the 5 intervention jurisdictions to be included in the prevalence survey. The effectiveness of the environmental intervention trial is being assessed based on the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework. Discussion The Children’s Healthy Living Program environmental trial is designed to focus on capacity building and to maximize the likelihood of sustainable impact on childhood obesity-related behaviors and outcomes. The multiple measures at the individual, community, and environment levels are designed to maximize the likelihood of detecting change. This approach enhances the likelihood for identifying and promoting the best methods to promote health and well-being of the children in the underserved US Affiliated Pacific Region. Trial registration NIH clinical trial # NCT01881373 PMID:24107083

Development of the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial Protocol: A National Cluster-Randomized Trial of Resident Duty Hour Policies.

PubMed

Bilimoria, Karl Y; Chung, Jeanette W; Hedges, Larry V; Dahlke, Allison R; Love, Remi; Cohen, Mark E; Tarpley, John; Mellinger, John; Mahvi, David M; Kelz, Rachel R; Ko, Clifford Y; Hoyt, David B; Lewis, Frank H

2016-03-01

Debate continues regarding whether to further restrict resident duty hour policies, but little high-level evidence is available to guide policy changes. To inform decision making regarding duty hour policies, the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial is being conducted to evaluate whether changing resident duty hour policies to permit greater flexibility in work hours affects patient postoperative outcomes, resident education, and resident well-being. Pragmatic noninferiority cluster-randomized trial of general surgery residency programs with 2 study arms. Participating in the study are Accreditation Council for Graduate Medical Education (ACGME)-approved US general surgery residency programs (n = 118), their affiliated hospitals (n = 154), surgical residents and program directors, and general surgery patients from July 1, 2014, to June 30, 2015, with additional patient safety outcomes collected through June 30, 2016. The data collection platform for patient outcomes is the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP), thus only hospitals participating in the ACS NSQIP were included. In the usual care arm, programs adhered to current ACGME resident duty hour standards. In the intervention arm, programs were allowed to deviate from current standards regarding maximum shift lengths and minimum time off between shifts through an ACGME waiver. Death or serious morbidity within 30 days of surgery measured through ACS NSQIP, as well as resident satisfaction and well-being measured through a survey delivered at the time of the 2015 American Board of Surgery in Training Examination (ABSITE). A total of 118 general surgery residency programs and 154 hospitals were enrolled in the FIRST Trial and randomized. Fifty-nine programs (73 hospitals) were randomized to the usual care arm and 59 programs (81 hospitals) were randomized to the intervention arm. Intent-to-treat analysis will be used to estimate the effectiveness of assignment to the intervention arm on patient outcomes, resident education, and resident well-being compared with the usual care arm. Several sensitivity analyses will be performed to determine whether there were differential effects when examining only inpatients, high-risk patients, and emergent/urgent cases. To our knowledge, the FIRST Trial is the first national randomized clinical trial of duty hour policies. Results of this study may be informative to policymakers and other stakeholders engaged in restructuring graduate medical training to enhance the quality of patient care and resident education. clinicaltrials.org Identifier: NCT02050789.

The performance of field scientists undertaking observations of early life fossils while in simulated space suit

NASA Astrophysics Data System (ADS)

Willson, D.; Rask, J. C.; George, S. C.; de Leon, P.; Bonaccorsi, R.; Blank, J.; Slocombe, J.; Silburn, K.; Steele, H.; Gargarno, M.; McKay, C. P.

2014-01-01

We conducted simulated Apollo Extravehicular Activity's (EVA) at the 3.45 Ga Australian 'Pilbara Dawn of life' (Western Australia) trail with field and non-field scientists using the University of North Dakota's NDX-1 pressurizable space suit to overview the effectiveness of scientist astronauts employing their field observation skills while looking for stromatolite fossil evidence. Off-world scientist astronauts will be faced with space suit limitations in vision, human sense perception, mobility, dexterity, the space suit fit, time limitations, and the psychological fear of death from accidents, causing physical fatigue reducing field science performance. Finding evidence of visible biosignatures for past life such as stromatolite fossils, on Mars, is a very significant discovery. Our preliminary overview trials showed that when in simulated EVAs, 25% stromatolite fossil evidence is missed with more incorrect identifications compared to ground truth surveys but providing quality characterization descriptions becomes less affected by simulated EVA limitations as the science importance of the features increases. Field scientists focused more on capturing high value characterization detail from the rock features whereas non-field scientists focused more on finding many features. We identified technologies and training to improve off-world field science performance. The data collected is also useful for NASA's "EVA performance and crew health" research program requirements but further work will be required to confirm the conclusions.

Sustained employability of workers in a production environment: design of a stepped wedge trial to evaluate effectiveness and cost-benefit of the POSE program

PubMed Central

2012-01-01

Background Sustained employability and health are generating awareness of employers in an aging and more complex work force. To meet these needs, employers may offer their employees health surveillance programs, to increase opportunities to work on health and sustained employability. However, evidence for these health surveillance programs is lacking. The FLESH study (Functional Labour Evaluation for Sustained Health and employment) was developed to evaluate a comprehensive workers’ health promotion program on its effectiveness, cost-benefit, and process of the intervention. Methods The study is designed as a cluster randomised stepped wedge trial with randomisation at company plant level and is carried out in a large meat processing company. Every contracted employee is offered the opportunity to participate in the POSE program (Promotion Of Sustained Employability). The main goals of the POSE program are 1) providing employee’s insight into their current employability and health status, 2) offering opportunities to improve employability and decrease health risks and 3) improving employability and health sustainably in order to keep them healthy at work. The program consists of a broad assessment followed by a counselling session and, if needed, a tailored intervention. Measurements will be performed at baseline and will be followed up at 20, 40, 60, 80, 106 and 132 weeks. The primary outcome measures are work ability, productivity and absenteeism. Secondary outcomes include health status, vitality, and psychosocial workload. A cost-benefit study will be conducted from the employers’ perspective. A process evaluation will be conducted and the satisfaction of employer and employees with the program will be assessed. Discussion This study provides information on the effectiveness of the POSE program on sustained employment. When the program proves to be effective, employees benefit by improved work ability, and health. Employers benefit from healthier employees, reduced sick leave (costs) and higher productivity. The study can expose key elements for a successful implementation and execution of the POSE program and may serve as an example to other companies inside and outside the industry. Trial registration The trial is registered at the Dutch Trial Register (http://www.trialregister.nl): NTR3445 PMID:23164366

High-Throughput Analytical Techniques for the Determination of the Residues of 653 Multiclass Pesticides and Chemical Pollutants in Tea, Part VII: A GC-MS, GC-MS/MS, and LC-MS/MS Study of the Degradation Profiles of Pesticide Residues in Green Tea.

PubMed

Chang, Qiao-Ying; Pang, Guo-Fang; Fan, Chun-Lin; Chen, Hui; Yang, Fang; Li, Jie; Wen, Bi-Fang

2016-11-01

GC-MS, GC-tandem MS (MS/MS), and LC-MS/MS were used to mathematically define the degradation profiles of pesticide residues in two field trials. Nineteen pesticides were studied in the first field trial and 11 in the second. The results of the field trials demonstrated that the degradation profiles of pesticide residues in green tea can be described with power functions to successfully estimate the amount of time, following pesticide application, pesticide residues appearing in tea in concentrations at and/or above the maximum residue limit (MRL) decrease to concentrations below the MRL. Stability tests on green tea samples stored at room temperature were conducted to determine whether pesticide-incurred green tea samples prepared according to the method used in the field trials would be suitable for the preparation of reference standards for laboratory-proficiency testing trials. This paper reports the results of a GC-MS, GC-MS/MS, and LC-MS/MS study, as well as the suitability of the samples prepared under these conditions for use as pesticide reference standards in tea analysis.

Impact of Different Visual Field Testing Paradigms on Sample Size Requirements for Glaucoma Clinical Trials.

PubMed

Wu, Zhichao; Medeiros, Felipe A

2018-03-20

Visual field testing is an important endpoint in glaucoma clinical trials, and the testing paradigm used can have a significant impact on the sample size requirements. To investigate this, this study included 353 eyes of 247 glaucoma patients seen over a 3-year period to extract real-world visual field rates of change and variability estimates to provide sample size estimates from computer simulations. The clinical trial scenario assumed that a new treatment was added to one of two groups that were both under routine clinical care, with various treatment effects examined. Three different visual field testing paradigms were evaluated: a) evenly spaced testing, b) United Kingdom Glaucoma Treatment Study (UKGTS) follow-up scheme, which adds clustered tests at the beginning and end of follow-up in addition to evenly spaced testing, and c) clustered testing paradigm, with clusters of tests at the beginning and end of the trial period and two intermediary visits. The sample size requirements were reduced by 17-19% and 39-40% using the UKGTS and clustered testing paradigms, respectively, when compared to the evenly spaced approach. These findings highlight how the clustered testing paradigm can substantially reduce sample size requirements and improve the feasibility of future glaucoma clinical trials.

Responses of Conophthorus spp. (Coleoptera: Scolytidae) to behavioral chemicals in field trials: a transcontinental perspective

Treesearch

Nancy G. Rappaport; John D. Stein; Adolfo Arturo del Rio Mora; Gary DeBarr; Peter de Groot; Sylvia Mori

2000-01-01

We tested six behavioral chemicals, pityol, conophthorin, 4-allylanisole, verbenone, 2-hexenol, and á-pinene, in a series of field trials directed at six combinations of Conophthorus Hopkins - Pinus L. spp. (Pinaceae) in sites distributed across North America. Beetle - host tree combinations included Conophthorus...

Implementing Interactive Telecommunications Services. Final Report on Problems Which Arise During Implementation of Field Trials and Demonstration Projects.

ERIC Educational Resources Information Center

Elton, Martin C. J.; Carey, John

Intended primarily for use by individuals about to assume responsibility for the implementation of field trials and demonstration projects built around interactive telecommunication systems, this report provides brief descriptions of 20 telemedicine projects, 12 teleconferencing projects, and seven involving two-way applications of cable…

Foliar fungicides on alfalfa: 2012 University extension field trial results from Minnesota and Wisconsin

USDA-ARS?s Scientific Manuscript database

To answer the increasing number of questions received regarding the use of foliar fungicide on alfalfa, a group of Extension and USDA Agricultural Research Station staff in southeastern Minnesota and Wisconsin worked together to conduct field research trials to examine the benefit of using a foliar ...

Simulation of superconducting tapes and coils with convex quadratic programming method

NASA Astrophysics Data System (ADS)

Zhang, Yan; Song, Yuntao; Wang, Lei; Liu, Xufeng

2015-08-01

Second-generation (2G) high-temperature superconducting coated conductors are playing an increasingly important role in power applications due to their large current density under high magnetic fields. In this paper, we conclude and explore the ability and possible potential of J formulation from the mathematical modeling point of view. An equivalent matrix form of J formulation has been presented and a relation between electromagnetic quantities and Karush-Kuhn-Tucker (KKT) conditions in optimization theory has been discovered. The use of the latest formulae to calculate inductance in a coil system and the primal-dual interior-point method algorithm is a trial to make the process of modeling stylized and build a bridge to commercial optimization solvers. Two different dependences of the critical current density on the magnetic field have been used in order to make a comparison with those published papers.

A Quantitative Evaluation of Dissolved Oxygen Instrumentation

NASA Technical Reports Server (NTRS)

Pijanowski, Barbara S.

1971-01-01

The implications of the presence of dissolved oxygen in water are discussed in terms of its deleterious or beneficial effects, depending on the functional consequences to those affected, e.g., the industrialist, the oceanographer, and the ecologist. The paper is devoted primarily to an examination of the performance of five commercially available dissolved oxygen meters. The design of each is briefly reviewed and ease or difficulty of use in the field described. Specifically, the evaluation program treated a number of parameters and user considerations including an initial check and trial calibration for each instrument and a discussion of the measurement methodology employed. Detailed test results are given relating to the effects of primary power variation, water-flow sensitivity, response time, relative accuracy of dissolved-oxygen readout, temperature accuracy (for those instruments which included this feature), error and repeatability, stability, pressure and other environmental effects, and test results obtained in the field. Overall instrument performance is summarized comparatively by chart.

A Model Program for Translational Medicine in Epilepsy Genetics

PubMed Central

Smith, Lacey A.; Ullmann, Jeremy F. P.; Olson, Heather E.; El Achkar, Christelle M.; Truglio, Gessica; Kelly, McKenna; Rosen-Sheidley, Beth; Poduri, Annapurna

2017-01-01

Recent technological advances in gene sequencing have led to a rapid increase in gene discovery in epilepsy. However, the ability to assess pathogenicity of variants, provide functional analysis, and develop targeted therapies has not kept pace with rapid advances in sequencing technology. Thus, although clinical genetic testing may lead to a specific molecular diagnosis for some patients, test results often lead to more questions than answers. As the field begins to focus on therapeutic applications of genetic diagnoses using precision medicine, developing processes that offer more than equivocal test results is essential. The success of precision medicine in epilepsy relies on establishing a correct genetic diagnosis, analyzing functional consequences of genetic variants, screening potential therapeutics in the preclinical laboratory setting, and initiating targeted therapy trials for patients. We describe the structure of a comprehensive, pediatric Epilepsy Genetics Program that can serve as a model for translational medicine in epilepsy. PMID:28056630

Adaptive Interventions and SMART Designs: Application to child behavior research in a community setting.

PubMed

Kidwell, Kelley M; Hyde, Luke W

2016-09-01

Heterogeneity between and within people necessitates the need for sequential personalized interventions to optimize individual outcomes. Personalized or adaptive interventions (AIs) are relevant for diseases and maladaptive behavioral trajectories when one intervention is not curative and success of a subsequent intervention may depend on individual characteristics or response. AIs may be applied to medical settings and to investigate best prevention, education, and community-based practices. AIs can begin with low-cost or low-burden interventions and followed with intensified or alternative interventions for those who need it most. AIs that guide practice over the course of a disease, program, or school year can be investigated through sequential multiple assignment randomized trials (SMARTs). To promote the use of SMARTs, we provide a hypothetical SMART in a Head Start program to address child behavior problems. We describe the advantages and limitations of SMARTs, particularly as they may be applied to the field of evaluation.

Architecture design of a generic centralized adjudication module integrated in a web-based clinical trial management system.

PubMed

Zhao, Wenle; Pauls, Keith

2016-04-01

Centralized outcome adjudication has been used widely in multicenter clinical trials in order to prevent potential biases and to reduce variations in important safety and efficacy outcome assessments. Adjudication procedures could vary significantly among different studies. In practice, the coordination of outcome adjudication procedures in many multicenter clinical trials remains as a manual process with low efficiency and high risk of delay. Motivated by the demands from two large clinical trial networks, a generic outcome adjudication module has been developed by the network's data management center within a homegrown clinical trial management system. In this article, the system design strategy and database structure are presented. A generic database model was created to transfer different adjudication procedures into a unified set of sequential adjudication steps. Each adjudication step was defined by one activate condition, one lock condition, one to five categorical data items to capture adjudication results, and one free text field for general comments. Based on this model, a generic outcome adjudication user interface and a generic data processing program were developed within a homegrown clinical trial management system to provide automated coordination of outcome adjudication. By the end of 2014, this generic outcome adjudication module had been implemented in 10 multicenter trials. A total of 29 adjudication procedures were defined with the number of adjudication steps varying from 1 to 7. The implementation of a new adjudication procedure in this generic module took an experienced programmer 1 or 2 days. A total of 7336 outcome events had been adjudicated and 16,235 adjudication step activities had been recorded. In a multicenter trial, 1144 safety outcome event submissions went through a three-step adjudication procedure and reported a median of 3.95 days from safety event case report form submission to adjudication completion. In another trial, 277 clinical outcome events were adjudicated by a six-step procedure and took a median of 23.84 days from outcome event case report form submission to adjudication procedure completion. A generic outcome adjudication module integrated in the clinical trial management system made the automated coordination of efficacy and safety outcome adjudication a reality. © The Author(s) 2015.

Olfactory source localization in the open field using one or both nostrils.

PubMed

Welge-Lussen, A; Looser, G L; Westermann, B; Hummel, T

2014-03-01

This study aims to examine humans ́ abilities to localize odorants within the open field. Young participants were tested on a localization task using a relatively selective olfactory stimulus (2-phenylethyl-alcohol, PEA) and cineol, an odorant with a strong trigeminal component. Participants were blindfolded and had to localize an odorant source at 2 m distance (far-field condition) and a 0.4 m distance (near-field condition) with either two nostrils open or only one open nostril. For the odorant with trigeminal properties, the number of correct trials did not differ when one or both nostrils were used, while more PEA localization trials were correctly completed with both rather than one nostril. In the near-field condition, correct localization was possible in 72-80% of the trials, irrespective of the odorant and the number of nostrils used. Localization accuracy, measured as spatial deviation from the olfactory source, was significantly higher in the near-field compared to the far-field condition, but independent of the odorant being localized. Odorant localization within the open field is difficult, but possible. In contrast to the general view, humans seem to be able to exploit the two-nostril advantage with increasing task difficulty.

First generation leishmaniasis vaccines: a review of field efficacy trials.

PubMed

Noazin, Sassan; Modabber, Farrokh; Khamesipour, Ali; Smith, Peter G; Moulton, Lawrence H; Nasseri, Kiumarss; Sharifi, Iraj; Khalil, Eltahir A G; Bernal, Ivan Dario Velez; Antunes, Carlos M F; Kieny, Marie Paule; Tanner, Marcel

2008-12-09

First generation candidate vaccines against leishmaniasis, prepared using inactivated whole parasites as their main ingredient, were considered as promising because of their relative ease of production and low cost. These vaccines have been the subject of many investigations over several decades and are the only leishmaniasis vaccine candidates which have undergone phase 3 clinical trial evaluation. Although the studies demonstrated the safety of the vaccines and several studies showed reasonable immunogenicity and some indication of protection, an efficacious prophylactic vaccine is yet to be identified. Despite this overall failure, these trials contributed significantly to increasing knowledge on human leishmaniasis immunology. To provide a collective view, this review discusses the methods and findings of field efficacy trials of first generation leishmaniasis vaccine clinical trials conducted in the Old and New Worlds.

Clinical trials of GMP products in the gene therapy field.

PubMed

Bamford, Kathleen B

2011-01-01

Advances in gene therapy are increasingly leading to clinical assessment in many fields of medicine with diverse approaches. The basic science stems from approaches aimed at different functions such as correcting a missing/abnormal gene, altering the proportion or expression of normal genes to augment a physiological process or using this principle to destroy malignant or infected cells. As the technology advances, it is increasingly important to ensure that clinical trials answer the questions that need to be asked. In this chapter we review examples of published clinical trials, resources for accessing information about registered trials, the process of regulating trials, good clinical practice, and good manufacturing practice as well as summarising the approach taken by regulatory authorities in reviewing applications for the introduction of products for use in the clinic.

"Scared Straight" and other juvenile awareness programs for preventing juvenile delinquency.

PubMed

Petrosino, A; Turpin-Petrosino, C; Buehler, J

2002-01-01

'Scared Straight' and other programmes involve organised visits to prison by juvenile delinquents or children at risk for criminal behavior. programmes are designed to deter participants from future offending through first-hand observation of prison life and interaction with adult inmates. These programmes remain in use world-wide despite studies and reviews questioning their effectiveness. To assess the effects of programmes comprising organised visits to prisons by juvenile delinquents (officially adjudicated or convicted by a juvenile court) or pre-delinquents (children in trouble but not officially adjudicated as delinquents), aimed at deterring them from criminal activity. Handsearching by the first author in identifying randomised field trials 1945-1993 relevant to criminology was augmented by structured searches of 16 electronic data bases, including the Campbell SPECTR database of trials and the Cochrane CCTR. Experts in the field were consulted and relevant citations were followed up. Studies that tested the effects of any program involving the organised visits of juvenile delinquents or children at-risk for delinquency to penal institutions were included. Studies that included overlapping samples of juvenile and young adults (e.g. ages 14-20) were included. We only considered studies that randomly or quasi-randomly (i.e. alternation) assigned participants to conditions. Each study had to have a no-treatment control condition with at least one outcome measure of "post-visit" criminal behavior. We report narratively on the nine eligible trials. We conducted one meta-analysis of post-intervention offending rates using official data. Information from other sources (e.g. self-report) was either missing from some studies or critical information was omitted (e.g. standard deviations). We examined the immediate post-treatment effects (i.e. "first-effects") by computing Odds Ratios (OR) for data on proportions of each group re-offending, and assumed both fixed and random effects models in our analyses. The analysis show the intervention to be more harmful than doing nothing. The program effect, whether assuming a fixed or random effects model, was nearly identical and negative in direction, regardless of the meta-analytic strategy. We conclude that programmes like 'Scared Straight' are likely to have a harmful effect and increase delinquency relative to doing nothing at all to the same youths. Given these results, agencies that permit such programmes must rigorously evaluate them not only to ensure that they are doing what they purport to do (prevent crime) - but at the very least they do not cause more harm than good.

Strategies for enhancing the implementation of school-based policies or practices targeting risk factors for chronic disease.

PubMed

Wolfenden, Luke; Nathan, Nicole K; Sutherland, Rachel; Yoong, Sze Lin; Hodder, Rebecca K; Wyse, Rebecca J; Delaney, Tessa; Grady, Alice; Fielding, Alison; Tzelepis, Flora; Clinton-McHarg, Tara; Parmenter, Benjamin; Butler, Peter; Wiggers, John; Bauman, Adrian; Milat, Andrew; Booth, Debbie; Williams, Christopher M

2017-11-29

A number of school-based policies or practices have been found to be effective in improving child diet and physical activity, and preventing excessive weight gain, tobacco or harmful alcohol use. Schools, however, frequently fail to implement such evidence-based interventions. The primary aims of the review are to examine the effectiveness of strategies aiming to improve the implementation of school-based policies, programs or practices to address child diet, physical activity, obesity, tobacco or alcohol use.Secondary objectives of the review are to: Examine the effectiveness of implementation strategies on health behaviour (e.g. fruit and vegetable consumption) and anthropometric outcomes (e.g. BMI, weight); describe the impact of such strategies on the knowledge, skills or attitudes of school staff involved in implementing health-promoting policies, programs or practices; describe the cost or cost-effectiveness of such strategies; and describe any unintended adverse effects of strategies on schools, school staff or children. All electronic databases were searched on 16 July 2017 for studies published up to 31 August 2016. We searched the following electronic databases: Cochrane Library including the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; MEDLINE In-Process & Other Non-Indexed Citations; Embase Classic and Embase; PsycINFO; Education Resource Information Center (ERIC); Cumulative Index to Nursing and Allied Health Literature (CINAHL); Dissertations and Theses; and SCOPUS. We screened reference lists of all included trials for citations of other potentially relevant trials. We handsearched all publications between 2011 and 2016 in two specialty journals (Implementation Science and Journal of Translational Behavioral Medicine) and conducted searches of the WHO International Clinical Trials Registry Platform (ICTRP) (http://apps.who.int/trialsearch/) as well as the US National Institutes of Health registry (https://clinicaltrials.gov). We consulted with experts in the field to identify other relevant research. 'Implementation' was defined as the use of strategies to adopt and integrate evidence-based health interventions and to change practice patterns within specific settings. We included any trial (randomised or non-randomised) conducted at any scale, with a parallel control group that compared a strategy to implement policies or practices to address diet, physical activity, overweight or obesity, tobacco or alcohol use by school staff to 'no intervention', 'usual' practice or a different implementation strategy. Citation screening, data extraction and assessment of risk of bias was performed by review authors in pairs. Disagreements between review authors were resolved via consensus, or if required, by a third author. Considerable trial heterogeneity precluded meta-analysis. We narratively synthesised trial findings by describing the effect size of the primary outcome measure for policy or practice implementation (or the median of such measures where a single primary outcome was not stated). We included 27 trials, 18 of which were conducted in the USA. Nineteen studies employed randomised controlled trial (RCT) designs. Fifteen trials tested strategies to implement healthy eating policies, practice or programs; six trials tested strategies targeting physical activity policies or practices; and three trials targeted tobacco policies or practices. Three trials targeted a combination of risk factors. None of the included trials sought to increase the implementation of interventions to delay initiation or reduce the consumption of alcohol. All trials examined multi-strategic implementation strategies and no two trials examined the same combinations of implementation strategies. The most common implementation strategies included educational materials, educational outreach and educational meetings. For all outcomes, the overall quality of evidence was very low and the risk of bias was high for the majority of trials for detection and performance bias.Among 13 trials reporting dichotomous implementation outcomes-the proportion of schools or school staff (e.g. classes) implementing a targeted policy or practice-the median unadjusted (improvement) effect sizes ranged from 8.5% to 66.6%. Of seven trials reporting the percentage of a practice, program or policy that had been implemented, the median unadjusted effect (improvement), relative to the control ranged from -8% to 43%. The effect, relative to control, reported in two trials assessing the impact of implementation strategies on the time per week teachers spent delivering targeted policies or practices ranged from 26.6 to 54.9 minutes per week. Among trials reporting other continuous implementation outcomes, findings were mixed. Four trials were conducted of strategies that sought to achieve implementation 'at scale', that is, across samples of at least 50 schools, of which improvements in implementation were reported in three trials.The impact of interventions on student health behaviour or weight status were mixed. Three of the eight trials with physical activity outcomes reported no significant improvements. Two trials reported reductions in tobacco use among intervention relative to control. Seven of nine trials reported no between-group differences on student overweight, obesity or adiposity. Positive improvements in child dietary intake were generally reported among trials reporting these outcomes. Three trials assessed the impact of implementation strategies on the attitudes of school staff and found mixed effects. Two trials specified in the study methods an assessment of potential unintended adverse effects, of which, they reported none. One trial reported implementation support did not significantly increase school revenue or expenses and another, conducted a formal economic evaluation, reporting the intervention to be cost-effective. Trial heterogeneity, and the lack of consistent terminology describing implementation strategies, were important limitations of the review. Given the very low quality of the available evidence, it is uncertain whether the strategies tested improve implementation of the targeted school-based policies or practices, student health behaviours, or the knowledge or attitudes of school staff. It is also uncertain if strategies to improve implementation are cost-effective or if they result in unintended adverse consequences. Further research is required to guide efforts to facilitate the translation of evidence into practice in this setting.

Testing Mediators of Intervention Effects in Randomized Controlled Trials: An Evaluation of Three Depression Prevention Programs

ERIC Educational Resources Information Center

Stice, Eric; Rohde, Paul; Seeley, John R.; Gau, Jeff M.

2010-01-01

Objective: Evaluate a new 5-step method for testing mediators hypothesized to account for the effects of depression prevention programs. Method: In this indicated prevention trial, at-risk teens with elevated depressive symptoms were randomized to a group cognitive-behavioral (CB) intervention, group supportive expressive intervention, CB…

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

ERIC Educational Resources Information Center

Leung, Cynthia; Tsang, Sandra; Heung, Kitty

2015-01-01

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

The Cost-Effectiveness of Education Interventions in Poor Countries. Policy Insight, Volume 2, Issue 4

ERIC Educational Resources Information Center

Evans, David K.; Ghosh, Arkadipta

2008-01-01

Poor countries need development programs that are both effective and cost-effective. To assess effectiveness, researchers are increasingly using randomized trials (or quasi-experimental methods that imitate randomized trials), which provide a clear picture of which outcomes are attributable to the program being evaluated. This "Policy Insight"…

Initial Open Trial of a Computerized Behavioral Activation Treatment for Depression

ERIC Educational Resources Information Center

Spates, C. Richard; Kalata, Alyssa H.; Ozeki, Satoshi; Stanton, Cory E.; Peters, Sofia

2013-01-01

This article presents preliminary findings from use of a novel computer program that implements an evidence-based psychological intervention to treat depression based on behavioral activation (BA) therapy. The program is titled “Building a Meaningful Life Through Behavioral Activation”. The findings derive from an open trial with moderate to…

Learning "about" and "from" Variation in Program Impacts Using Multisite Trials. MDRC Working Papers on Research Methodology

ERIC Educational Resources Information Center

Raudenbush, Stephen W.; Bloom, Howard S.

2015-01-01

The present paper, which is intended for a diverse audience of evaluation researchers, applied social scientists, and research funders, provides a broad overview of the conceptual and statistical issues involved in using multisite randomized trials to learn "about" and "from" variation in program effects across…

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

USDA-ARS?s Scientific Manuscript database

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

An Evaluation of Programmed Treatment-integrity Errors during Discrete-trial Instruction

ERIC Educational Resources Information Center

Carroll, Regina A.; Kodak, Tiffany; Fisher, Wayne W.

2013-01-01

This study evaluated the effects of programmed treatment-integrity errors on skill acquisition for children with an autism spectrum disorder (ASD) during discrete-trial instruction (DTI). In Study 1, we identified common treatment-integrity errors that occur during academic instruction in schools. In Study 2, we simultaneously manipulated 3…

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…

Applied Behavior Analysis: Beyond Discrete Trial Teaching

ERIC Educational Resources Information Center

Steege, Mark W.; Mace, F. Charles; Perry, Lora; Longenecker, Harold

2007-01-01

We discuss the problem of autism-specific special education programs representing themselves as Applied Behavior Analysis (ABA) programs when the only ABA intervention employed is Discrete Trial Teaching (DTT), and often for limited portions of the school day. Although DTT has many advantages to recommend its use, it is not well suited to teach…

Fit 5 Kids TV reduction program for Latino preschoolers: A cluster randomized controlled trial

USDA-ARS?s Scientific Manuscript database

Reducing Latino preschoolers' TV viewing is needed to reduce their risk of obesity and other chronic diseases. This study's objective was to evaluate the Fit 5 Kids (F5K) TV reduction program's impact on Latino preschooler's TV viewing. The study design was a cluster randomized controlled trial (RCT...

Randomized Control Trial of a CBT Trauma Recovery Program in Palestinian Schools

ERIC Educational Resources Information Center

Barron, Ian G.; Abdallah, Ghassan; Smith, Patrick

2013-01-01

The current study aimed to assess the Teaching Recovery Techniques (TRT) trauma recovery program within the context of ongoing violence. Utilizing a randomized controlled trial, 11-14-year-old students in Nablus, Palestine, were allocated by class to intervention or wait-list control conditions. Standardized measures assessed trauma exposure,…

Management of Hypertension in Private Practice: A Randomized Controlled Trial in Continuing Medical Education.

ERIC Educational Resources Information Center

Gullion, David S.; And Others

1988-01-01

A randomized control trial was used to evaluate a physician education program designed to improve physician management of patients' hypertension, hypertension-related behaviors, and diastolic blood pressure. It was suggested that more intensive continuing medical education programs are needed to improve physician performance and patient outcome.…

78 FR 64389 - Policy To Encourage Trial Disclosure Programs; Information Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-29

... protections to companies to conduct trial disclosure programs. This authority can be used to help further the... period, the Bureau will deem a testing company's disclosure, to the extent that it is used in accordance... enabling companies to research informative, cost- effective disclosures. The Bureau also recognizes that in...

Successful Outcomes from a Structured Curriculum Used in the Veterans Affairs Low Vision Intervention Trial

ERIC Educational Resources Information Center

Stelmack, Joan A.; Rinne, Stephen; Mancil, Rickilyn M.; Dean, Deborah; Moran, D'Anna; Tang, X. Charlene; Cummings, Roger; Massof, Robert W.

2008-01-01

A low vision rehabilitation program with a structured curriculum was evaluated in a randomized controlled trial. The treatment group demonstrated large improvements in self-reported visual function (reading, mobility, visual information processing, visual motor skills, and overall). The team approach and the protocols of the treatment program are…

Webcam Delivery of the Camperdown Program for Adolescents Who Stutter: A Phase II Trial

ERIC Educational Resources Information Center

Carey, Brenda; O'Brian, Sue; Lowe, Robyn; Onslow, Mark

2014-01-01

Purpose: This Phase II clinical trial examined stuttering adolescents' responsiveness to the Webcam-delivered Camperdown Program. Method: Sixteen adolescents were treated by Webcam with no clinic attendance. Primary outcome was percentage of syllables stuttered (%SS). Secondary outcomes were number of sessions, weeks and hours to maintenance,…

The effect of India's total sanitation campaign on defecation behaviors and child health in rural Madhya Pradesh: a cluster randomized controlled trial.

PubMed

Patil, Sumeet R; Arnold, Benjamin F; Salvatore, Alicia L; Briceno, Bertha; Ganguly, Sandipan; Colford, John M; Gertler, Paul J

2014-08-01

Poor sanitation is thought to be a major cause of enteric infections among young children. However, there are no previously published randomized trials to measure the health impacts of large-scale sanitation programs. India's Total Sanitation Campaign (TSC) is one such program that seeks to end the practice of open defecation by changing social norms and behaviors, and providing technical support and financial subsidies. The objective of this study was to measure the effect of the TSC implemented with capacity building support from the World Bank's Water and Sanitation Program in Madhya Pradesh on availability of individual household latrines (IHLs), defecation behaviors, and child health (diarrhea, highly credible gastrointestinal illness [HCGI], parasitic infections, anemia, growth). We conducted a cluster-randomized, controlled trial in 80 rural villages. Field staff collected baseline measures of sanitation conditions, behaviors, and child health (May-July 2009), and revisited households 21 months later (February-April 2011) after the program was delivered. The study enrolled a random sample of 5,209 children <5 years old from 3,039 households that had at least one child <24 months at the beginning of the study. A random subsample of 1,150 children <24 months at enrollment were tested for soil transmitted helminth and protozoan infections in stool. The randomization successfully balanced intervention and control groups, and we estimated differences between groups in an intention to treat analysis. The intervention increased percentage of households in a village with improved sanitation facilities as defined by the WHO/UNICEF Joint Monitoring Programme by an average of 19% (95% CI for difference: 12%-26%; group means: 22% control versus 41% intervention), decreased open defecation among adults by an average of 10% (95% CI for difference: 4%-15%; group means: 73% intervention versus 84% control). However, the intervention did not improve child health measured in terms of multiple health outcomes (diarrhea, HCGI, helminth infections, anemia, growth). Limitations of the study included a relatively short follow-up period following implementation, evidence for contamination in ten of the 40 control villages, and bias possible in self-reported outcomes for diarrhea, HCGI, and open defecation behaviors. The intervention led to modest increases in availability of IHLs and even more modest reductions in open defecation. These improvements were insufficient to improve child health outcomes (diarrhea, HCGI, parasite infection, anemia, growth). The results underscore the difficulty of achieving adequately large improvements in sanitation levels to deliver expected health benefits within large-scale rural sanitation programs. ClinicalTrials.gov NCT01465204. Please see later in the article for the Editors' Summary.

Predictors of Study Attrition in a Randomized Controlled Trial Evaluating a Perinatal Home-Visiting Program with Mothers with Psychosocial Vulnerabilities

PubMed Central

Foulon, Stéphanie; Greacen, Tim; Pasquet, Blandine; Dugravier, Romain; Saïas, Thomas; Guedeney, Nicole; Guedeney, Antoine; Tubach, Florence

2015-01-01

Objective Randomised controlled trials evaluating perinatal home-visiting programs are frequently confronted with the problem of high attrition rates. The aim of the present study is to identify predictors of study attrition in a trial evaluating a perinatal home-visiting program in France. Materials and Methods CAPEDP is a French randomized trial comparing a perinatal home-visiting program using psychologists versus usual care (N = 440). The first assessment was at inclusion into the trial at the 27th week of pregnancy and the final assessment when the child reached the age of two. Attrition rates were calculated at 3 and 24 months postpartum. Stepwise logistic regression was used to identify predictors of early (between inclusion and 3 months postpartum) and later (between 3 and 24 months postpartum) attrition among social, psychological and parenting factors. Results Attrition rates were 17% and 63% at 3 and 24 months respectively. At 24 months, there was significantly more attrition in the control arm (70.6%) compared to the intervention arm (55.2%). Five independent predictors of early attrition were identified: having already had an abortion; having greater attachment insecurity as measured with the Vulnerable Attachment Style Questionnaire (VASQ); having lower global severity of psychiatric symptoms as assessed with the Symptom Check-List (SCL-90) at inclusion, being neither currently employed nor studying; and declaring no tobacco consumption during pregnancy. Being randomized into the control arm, having undergone early parental loss before age 11 and having lower global severity of psychiatric symptoms (SCL-90) at 3 months postpartum were the only variables associated with later attrition. Conclusion This study provides key information for identifying mothers who may require specific support to avoid study attrition in trials evaluating a home-visiting program. PMID:26554839

Improving coronary heart disease self-management using mobile technologies (Text4Heart): a randomised controlled trial protocol.

PubMed

Dale, Leila Pfaeffli; Whittaker, Robyn; Jiang, Yannan; Stewart, Ralph; Rolleston, Anna; Maddison, Ralph

2014-03-04

Cardiac rehabilitation (CR) is a secondary prevention program that offers education and support to assist patients with coronary heart disease (CHD) make lifestyle changes. Despite the benefits of CR, attendance at centre-based sessions remains low. Mobile technology (mHealth) has potential to reach more patients by delivering CR directly to mobile phones, thus providing an alternative to centre-based CR. The aim of this trial is to evaluate if a mHealth comprehensive CR program can improve adherence to healthy lifestyle behaviours (for example, physically active, fruit and vegetable intake, not smoking, low alcohol consumption) over and above usual CR services in New Zealand adults diagnosed with CHD. A two-arm, parallel, randomised controlled trial will be conducted at two Auckland hospitals in New Zealand. One hundred twenty participants will be randomised to receive a 24-week evidence- and theory-based personalised text message program and access to a supporting website in addition to usual CR care or usual CR care alone (control). The primary outcome is the proportion of participants adhering to healthy behaviours at 6 months, measured using a composite health behaviour score. Secondary outcomes include overall cardiovascular disease risk, body composition, illness perceptions, self-efficacy, hospital anxiety/depression and medication adherence. This study is one of the first to examine an mHealth-delivered comprehensive CR program. Strengths of the trial include quality research design and in-depth description of the intervention to aid replication. If effective, the trial has potential to augment standard CR practices and to be used as a model for other disease prevention or self-management programs. Australian New Zealand Clinical Trials Registry: ACTRN12613000901707.

A school-based intervention improved dietary intake outcomes and reduced waist circumference in adolescents: a cluster randomized controlled trial.

PubMed

Ochoa-Avilés, Angélica; Verstraeten, Roosmarijn; Huybregts, Lieven; Andrade, Susana; Van Camp, John; Donoso, Silvana; Ramírez, Patricia Liliana; Lachat, Carl; Maes, Lea; Kolsteren, Patrick

2017-12-11

In Ecuador, adolescents' food intake does not comply with guidelines for a healthy diet. Together with abdominal obesity adolescent's inadequate diets are risk factors for non-communicable diseases. We report the effectiveness of a school-based intervention on the dietary intake and waist circumference among Ecuadorian adolescents. A pair-matched cluster randomized controlled trial including 1430 adolescents (12-14 years old) was conducted. The program aimed at improving the nutritional value of dietary intake, physical activity (primary outcomes), body mass index, waist circumference and blood pressure (secondary outcomes). This paper reports: (i) the effect on fruit and vegetable intake, added sugar intake, unhealthy snacking (consumption of unhealthy food items that are not in line with the dietary guidelines eaten during snack time; i.e. table sugar, sweets, salty snacks, fast food, soft drinks and packaged food), breakfast intake and waist circumference; and, (ii) dose and reach of the intervention. Dietary outcomes were estimated by means of two 24-h recall at baseline, after the first 17-months (stage one) and after the last 11-months (stage two) of implementation. Dose and reach were evaluated using field notes and attendance forms. Educational toolkits and healthy eating workshops with parents and food kiosks staff in the schools were implemented in two different stages. The overall effect was assessed using linear mixed models and regression spline mixed effect models were applied to evaluate the effect after each stage. Data from 1046 adolescents in 20 schools were analyzed. Participants from the intervention group consumed lower quantities of unhealthy snacks (-23.32 g; 95% CI: -45.25,-1.37) and less added sugar (-5.66 g; 95% CI: -9.63,-1.65) at the end of the trial. Daily fruit and vegetable intake decreased in both the intervention and control groups compared to baseline, albeit this decrease was 23.88 g (95% CI: 7.36, 40.40) lower in the intervention group. Waist circumference (-0.84 cm; 95% CI: -1.68, 0.28) was lower in the intervention group at the end of the program; the effect was mainly observed at stage one. Dose and reach were also higher at stage one. The trial had positive effects on risk factors for non-communicable diseases, i.e. decreased consumption of unhealthy snacks. The program strategies must be implemented at the national level through collaboration between the academia and policy makers to assure impact at larger scale. ClinicalTrial.gov-NCT01004367 .

Electronic Clinical Trial Protocol Distribution via the World-Wide Web

PubMed Central

Afrin, Lawrence B.; Kuppuswamy, Valarmathi; Slater, Barbara; Stuart, Robert K.

1997-01-01

Clinical trials today typically are inefficient, paper-based operations. Poor community physician awareness of available trials and difficult referral mechanisms also contribute to poor accrual. The Physicians Research Network (PRN) web was developed for more efficient trial protocol distribution and eligibility inquiries. The Medical University of South Carolina's Hollings Cancer Center trials program and two community oncology practices served as a testbed. In 581 man-hours over 18 months, 147 protocols were loaded into PRN. The trials program eliminated all protocol hardcopies except the masters, reduced photocopier use 59%, and saved 1.0 full-time equivalents (FTE), but 1.0 FTE was needed to manage PRN. There were no known security breaches, downtime, or content-related problems. Therefore, PRN is a paperless, user-preferred, reliable, secure method for distributing protocols and reducing distribution errors and delays because only a single copy of each protocol is maintained. Furthermore, PRN is being extended to serve other aspects of trial operations. PMID:8988471

Exercise programs may be effective in preventing a new episode of neck pain: a systematic review and meta-analysis.

PubMed

de Campos, Tarcisio F; Maher, Chris G; Steffens, Daniel; Fuller, Joel T; Hancock, Mark J

2018-06-13

What is the effectiveness of interventions that aim to prevent a new episode of neck pain? Systematic review and meta-analysis of randomised, controlled trials. People without neck pain at study entry. Any intervention aiming to prevent a future episode of neck pain. New episode of neck pain. Five trials including a total of 3852 individuals met the inclusion criteria. The pooled results from two randomised, controlled trials (500 participants) found moderate-quality evidence that exercise reduces the risk of a new episode of neck pain (OR 0.32, 95% CI 0.12 to 0.86). One of the meta-analysed trials included some co-interventions with the exercise. There was low-quality evidence from three randomised, controlled trials (3352 participants) that ergonomic programs do not reduce the risk of a new neck pain episode (OR 1.00, 95% CI 0.74 to 1.35). This review found moderate-quality evidence supporting the effectiveness of an exercise program for reducing the risk of a new episode of neck pain. There is a need for high-quality randomised, controlled trials evaluating interventions to prevent new episodes of neck pain. PROSPERO CRD42017055174. [de Campos TF, Maher CG, Steffens D, Fuller JT, Hancock MJ (2018) Exercise programs may be effective in preventing a new episode of neck pain: a systematic review. Journal of Physiotherapy XX: XX-XX]. Copyright © 2018 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.

Sexual assault resistance education for university women: study protocol for a randomized controlled trial (SARE trial)

PubMed Central

2013-01-01

Background More than one in six women will be sexually assaulted in their lifetimes, most by men they know. The situation on university campuses is even more startling, with as many as 1 in 4 female students being victims of rape or attempted rape. The associated physical and mental health effects are extensive and the social and economic costs are staggering. The aim of this randomized controlled trial is to determine whether a novel, small-group sexual assault resistance education program can reduce the incidence of sexual assault among university-attending women, when compared to current university practice of providing informational brochures. Methods/Design The trial will evaluate a theoretically and empirically sound four-unit, 12-hour education program that has been demonstrated in pilot studies to have short-term efficacy. Three of the four units provide information, skills, and practice aimed at decreasing the time needed for women to assess situations with elevated risk of acquaintance sexual assault as dangerous and to take action, reducing emotional obstacles to taking action, and increasing the use of the most effective methods of verbal and physical self-defense. The fourth unit focuses on facilitating a stronger positive sexuality from which women may resist sexual coercion by male intimates more successfully. The trial will extend the pilot evaluations by expanding the participant pool and examining the long term efficacy of the program. A total of 1716 first-year female students (age 17 to 24 years) from three Canadian universities will be enrolled. The primary outcome is completed sexual assault, measured by The Sexual Experiences Survey - Short Form Victimization instrument. Secondary outcomes include changes in knowledge, attitudes, and skills related to the process of sexual assault resistance. Outcomes will be measured at baseline, 1 week, 6, 12, 18, and 24 months. Discussion The results of the trial will be used to produce a maximally effective sexual assault resistance education program that can be adopted by universities, to assess whether aspects of the program need to be strengthened, and also to indicate how long the effects of the program last and at which point in time refresher sessions may be necessary. Trial registration ClinicalTrials.gov NCT01338428 PMID:23702221

Moving from Efficacy to Effectiveness Trials in Prevention Research

PubMed Central

Marchand, Erica; Stice, Eric; Rohde, Paul; Becker, Carolyn Black

2013-01-01

Efficacy trials test whether interventions work under optimal, highly controlled conditions whereas effectiveness trials test whether interventions work with typical clients and providers in real-world settings. Researchers, providers, and funding bodies have called for more effectiveness trials to understand whether interventions produce effects under ecologically valid conditions, which factors predict program effectiveness, and what strategies are needed to successfully implement programs in practice settings. The transition from efficacy to effectiveness with preventive interventions involves unique considerations, some of which are not shared by treatment research. The purpose of this article is to discuss conceptual and methodological issues that arise when making the transition from efficacy to effectiveness research in primary, secondary, and tertiary prevention, drawing on the experiences of two complimentary research groups as well as the existing literature. We address (a) program of research, (b) intervention design and conceptualization, (c) participant selection and characteristics, (d) providers, (e) context, (f) measurement and methodology, (g) outcomes, (h) cost, and (i) sustainability. We present examples of research in eating disorder prevention that demonstrate the progression from efficacy to effectiveness trials. PMID:21092935

Update on the everolimus-eluting coronary stent system: results and implications from the SPIRIT clinical trial program

PubMed Central

Kirchner, R Michael; Abbott, J Dawn

2009-01-01

Drug-eluting stents (DES) have had a major impact in interventional cardiology. Compared to bare metal stents, they significantly reduce restenosis and the need for target vessel revascularization. Four DES are available in the US, the first-generation sirolimus-eluting (Cypher®) and paclitaxel-eluting (Taxus®) stents and later approved second-generation everolimus-eluting (Xience V®) and zotarolimus-eluting (Endeavor®) stents. The Xience V stent was approved on the basis of clinical efficacy and safety data from 3 studies in the SPIRIT clinical trial program. Within this trial series, the Xience V was superior to its bare metal stent counterpart, the Vision® stent, and noninferior to the paclitaxel-eluting stent for target vessel failure at 9 months. This review provides a comprehensive assessment of the data derived from both the pre- and post-approval randomized controlled trials and registry studies of Xience V that comprise the SPIRIT clinical trial program including recently published mid-term outcomes. The implications of the results in terms of interventional practice will be discussed. PMID:20057901

Physiotherapy interventions for ankylosing spondylitis.

PubMed

Dagfinrud, H; Kvien, T K; Hagen, K B

2008-01-23

Ankylosing spondylitis (AS) is a chronic, inflammatory rheumatic disease. Physiotherapy is considered an important part of the overall management of AS. To summarise the available scientific evidence on the effectiveness of physiotherapy interventions in the management of AS. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, AMED, CINAHL and PEDro up to January 2007 for all relevant publications, without any language restrictions. We checked the reference lists of relevant articles and contacted the authors of included articles. We included randomised and quasi-randomised studies with AS patients and where at least one of the comparison groups received physiotherapy. The main outcomes of interest were pain, stiffness, spinal mobility, physical function and patient global assessment. Two reviewers independently selected trials for inclusion, extracted data and assessed trial quality. Investigators were contacted to obtain missing information. Eleven trials with a total of 763 participants were included in this updated review. Four trials compared individualised home exercise programs or a supervised exercise program with no intervention and reported low quality evidence for effects in spinal mobility (Relative percentage differences (RPDs) from 5-50%) and physical function (four points on a 33-point scale). Three trials compared supervised group physiotherapy with an individualised home-exercise program and reported moderate quality evidence for small differences in spinal mobility (RPDs 7.5-18%) and patient global assessment (1.46 cm) in favour of supervised group exercises. In one study, a three-week inpatient spa-exercise therapy followed by 37 weeks of weekly outpatient group physiotherapy (without spa) was compared with weekly outpatient group physiotherapy alone; there was moderate quality evidence for effects in pain (18%), physical function (24%) and patient global assessment (27%) in favour of the combined spa-exercise therapy. One study compared daily outpatient balneotherapy and an exercise program with only exercise program, and another study compared balneotherapy with fresh water therapy. None of these studies showed significant between-group differences. One study compared an experimental exercise program with a conventional program; statistically significant change scores were reported on nearly all spinal mobility measures and physical function in favour of the experimental program. The results of this review suggest that an individual home-based or supervised exercise program is better than no intervention; that supervised group physiotherapy is better than home exercises; and that combined inpatient spa-exercise therapy followed by group physiotherapy is better than group physiotherapy alone.

A Hybrid Effectiveness-Implementation Trial of an Evidence-Based Exercise Intervention for Breast Cancer Survivors

PubMed Central

Beidas, Rinad S.; Paciotti, Breah; Barg, Fran; Branas, Andrea R.; Brown, Justin C.; Glanz, Karen; DeMichele, Angela; DiGiovanni, Laura; Salvatore, Domenick

2014-01-01

Background The primary aims of this hybrid Type 1 effectiveness-implementation trial were to quantitatively assess whether an evidence-based exercise intervention for breast cancer survivors, Strength After Breast Cancer, was safe and effective in a new setting and to qualitatively assess barriers to implementation. Methods A cohort of 84 survivors completed measurements related to limb volume, muscle strength, and body image at baseline, 67 survivors completed measurements 12 months later. Qualitative methods were used to understand barriers to implementation experienced by referring oncology clinicians and physical therapists who delivered the program. Results Similar to the efficacy trial, the revised intervention demonstrated safety with regard to lymphedema, and led to improvements in lymphedema symptoms, muscular strength, and body image. Comparison of effects in the effectiveness trial to effects in the efficacy trial revealed larger strength increases in the efficacy trial than in the effectiveness trial (P < .04), but few other differences were found. Qualitative implementation data suggested significant barriers around intervention characteristics, payment, eligibility criteria, the referral process, the need for champions (ie, advocates), and the need to adapt during implementation of the intervention, which should be considered in future dissemination and implementation efforts. Conclusions This trial successfully demonstrated that a physical therapy led strength training program for breast cancer survivors can be implemented in a community setting while retaining the effectiveness and safety of the clinical trial. However, during the translation process, strategies to reduce barriers to implementation are required. This new program can inform larger scale dissemination and implementation efforts. PMID:25749601

Field trial of a quantum secured 10 Gb/s DWDM transmission system over a single installed fiber.

PubMed

Choi, Iris; Zhou, Yu Rong; Dynes, James F; Yuan, Zhiliang; Klar, Andreas; Sharpe, Andrew; Plews, Alan; Lucamarini, Marco; Radig, Christian; Neubert, Jörg; Griesser, Helmut; Eiselt, Michael; Chunnilall, Christopher; Lepert, Guillaume; Sinclair, Alastair; Elbers, Jörg-Peter; Lord, Andrew; Shields, Andrew

2014-09-22

We present results from the first field-trial of a quantum-secured DWDM transmission system, in which quantum key distribution (QKD) is combined with 4 × 10 Gb/s encrypted data and transmitted simultaneously over 26 km of field installed fiber. QKD is used to frequently refresh the key for AES-256 encryption of the 10 Gb/s data traffic. Scalability to over 40 DWDM channels is analyzed.

Systematic review: an evaluation of major commercial weight loss programs in the United States.

PubMed

Tsai, Adam Gilden; Wadden, Thomas A

2005-01-04

Each year millions of Americans enroll in commercial and self-help weight loss programs. Health care providers and their obese patients know little about these programs because of the absence of systematic reviews. To describe the components, costs, and efficacy of the major commercial and organized self-help weight loss programs in the United States that provide structured in-person or online counseling. Review of company Web sites, telephone discussion with company representatives, and search of the MEDLINE database. Randomized trials at least 12 weeks in duration that enrolled only adults and assessed interventions as they are usually provided to the public, or case series that met these criteria, stated the number of enrollees, and included a follow-up evaluation that lasted 1 year or longer. Data were extracted on study design, attrition, weight loss, duration of follow-up, and maintenance of weight loss. We found studies of eDiets.com, Health Management Resources, Take Off Pounds Sensibly, OPTIFAST, and Weight Watchers. Of 3 randomized, controlled trials of Weight Watchers, the largest reported a loss of 3.2% of initial weight at 2 years. One randomized trial and several case series of medically supervised very-low-calorie diet programs found that patients who completed treatment lost approximately 15% to 25% of initial weight. These programs were associated with high costs, high attrition rates, and a high probability of regaining 50% or more of lost weight in 1 to 2 years. Commercial interventions available over the Internet and organized self-help programs produced minimal weight loss. Because many studies did not control for high attrition rates, the reported results are probably a best-case scenario. With the exception of 1 trial of Weight Watchers, the evidence to support the use of the major commercial and self-help weight loss programs is suboptimal. Controlled trials are needed to assess the efficacy and cost-effectiveness of these interventions.

A Fully Automated Diabetes Prevention Program, Alive-PD: Program Design and Randomized Controlled Trial Protocol

PubMed Central

Azar, Kristen MJ; Block, Torin J; Romanelli, Robert J; Carpenter, Heather; Hopkins, Donald; Palaniappan, Latha; Block, Clifford H

2015-01-01

Background In the United States, 86 million adults have pre-diabetes. Evidence-based interventions that are both cost effective and widely scalable are needed to prevent diabetes. Objective Our goal was to develop a fully automated diabetes prevention program and determine its effectiveness in a randomized controlled trial. Methods Subjects with verified pre-diabetes were recruited to participate in a trial of the effectiveness of Alive-PD, a newly developed, 1-year, fully automated behavior change program delivered by email and Web. The program involves weekly tailored goal-setting, team-based and individual challenges, gamification, and other opportunities for interaction. An accompanying mobile phone app supports goal-setting and activity planning. For the trial, participants were randomized by computer algorithm to start the program immediately or after a 6-month delay. The primary outcome measures are change in HbA1c and fasting glucose from baseline to 6 months. The secondary outcome measures are change in HbA1c, glucose, lipids, body mass index (BMI), weight, waist circumference, and blood pressure at 3, 6, 9, and 12 months. Randomization and delivery of the intervention are independent of clinic staff, who are blinded to treatment assignment. Outcomes will be evaluated for the intention-to-treat and per-protocol populations. Results A total of 340 subjects with pre-diabetes were randomized to the intervention (n=164) or delayed-entry control group (n=176). Baseline characteristics were as follows: mean age 55 (SD 8.9); mean BMI 31.1 (SD 4.3); male 68.5%; mean fasting glucose 109.9 (SD 8.4) mg/dL; and mean HbA1c 5.6 (SD 0.3)%. Data collection and analysis are in progress. We hypothesize that participants in the intervention group will achieve statistically significant reductions in fasting glucose and HbA1c as compared to the control group at 6 months post baseline. Conclusions The randomized trial will provide rigorous evidence regarding the efficacy of this Web- and Internet-based program in reducing or preventing progression of glycemic markers and indirectly in preventing progression to diabetes. Trial Registration ClinicalTrials.gov NCT01479062; http://clinicaltrials.gov/show/NCT01479062 (Archived by WebCite at http://www.webcitation.org/6U8ODy1vo). PMID:25608692

Redesigning Radiotherapy Quality Assurance: Opportunities to Develop an Efficient, Evidence-Based System to Support Clinical Trials

PubMed Central

Bekelman, Justin E.; Deye, James A.; Vikram, Bhadrasain; Bentzen, Soren M.; Bruner, Deborah; Curran, Walter J.; Dignam, James; Efstathiou, Jason A.; FitzGerald, T. J.; Hurkmans, Coen; Ibbott, Geoffrey S.; Lee, J. Jack; Merchant, Timothy E.; Michalski, Jeff; Palta, Jatinder R.; Simon, Richard; Ten Haken, Randal K.; Timmerman, Robert; Tunis, Sean; Coleman, C. Norman; Purdy, James

2012-01-01

Background In the context of national calls for reorganizing cancer clinical trials, the National Cancer Institute (NCI) sponsored a two day workshop to examine the challenges and opportunities for optimizing radiotherapy quality assurance (QA) in clinical trial design. Methods Participants reviewed the current processes of clinical trial QA and noted the QA challenges presented by advanced technologies. Lessons learned from the radiotherapy QA programs of recent trials were discussed in detail. Four potential opportunities for optimizing radiotherapy QA were explored, including the use of normal tissue toxicity and tumor control metrics, biomarkers of radiation toxicity, new radiotherapy modalities like proton beam therapy, and the international harmonization of clinical trial QA. Results Four recommendations were made: 1) Develop a tiered (and more efficient) system for radiotherapy QA and tailor intensity of QA to clinical trial objectives. Tiers include (i) general credentialing, (ii) trial specific credentialing, and (iii) individual case review; 2) Establish a case QA repository; 3) Develop an evidence base for clinical trial QA and introduce innovative prospective trial designs to evaluate radiotherapy QA in clinical trials; and 4) Explore the feasibility of consolidating clinical trial QA in the United States. Conclusion Radiotherapy QA may impact clinical trial accrual, cost, outcomes and generalizability. To achieve maximum benefit, QA programs must become more efficient and evidence-based. PMID:22425219

Trial-by-trial adaptation of movements during mental practice under force field.

PubMed

Anwar, Muhammad Nabeel; Khan, Salman Hameed

2013-01-01

Human nervous system tries to minimize the effect of any external perturbing force by bringing modifications in the internal model. These modifications affect the subsequent motor commands generated by the nervous system. Adaptive compensation along with the appropriate modifications of internal model helps in reducing human movement errors. In the current study, we studied how motor imagery influences trial-to-trial learning in a robot-based adaptation task. Two groups of subjects performed reaching movements with or without motor imagery in a velocity-dependent force field. The results show that reaching movements performed with motor imagery have relatively a more focused generalization pattern and a higher learning rate in training direction.

Edgewood Chemical Biological Center In-House Laboratory Independent Research Program Annual Report FY11

DTIC Science & Technology

2011-01-01

flow rates which were held constant from trial to trial by critical orifices, were checked with several different calibrated mass flow meters. None of...processes or products in mind”. ECBC views the ILIR program as a critical part of its efforts to ensure a high level of basic science, foster innovation in...missions. The ILIR program solicits innovative proposals from the Center’s principal investigators (PI) that correspond to ECBC’s critical core

A community intervention trial of multimodal suicide prevention program in Japan: a novel multimodal community intervention program to prevent suicide and suicide attempt in Japan, NOCOMIT-J.

PubMed

Ono, Yutaka; Awata, Shuichi; Iida, Hideharu; Ishida, Yasushi; Ishizuka, Naoki; Iwasa, Hiroto; Kamei, Yuichi; Motohashi, Yutaka; Nakagawa, Atsuo; Nakamura, Jun; Nishi, Nobuyuki; Otsuka, Kotaro; Oyama, Hirofumi; Sakai, Akio; Sakai, Hironori; Suzuki, Yuriko; Tajima, Miyuki; Tanaka, Eriko; Uda, Hidenori; Yonemoto, Naohiro; Yotsumoto, Toshihiko; Watanabe, Naoki

2008-09-15

To respond to the rapid surge in the incidence of suicide in Japan, which appears to be an ongoing trend, the Japanese Multimodal Intervention Trials for Suicide Prevention (J-MISP) have launched a multimodal community-based suicide prevention program, NOCOMIT-J. The primary aim of this study is to examine whether NOCOMIT-J is effective in reducing suicidal behavior in the community. This study is a community intervention trial involving seven intervention regions with accompanying control regions, all with populations of statistically sufficient size. The program focuses on building social support networks in the public health system for suicide prevention and mental health promotion, intending to reinforce human relationships in the community. The intervention program components includes a primary prevention measures of awareness campaign for the public and key personnel, secondary prevention measures for screening of, and assisting, high-risk individuals, after-care for individuals bereaved by suicide, and other measures. The intervention started in July 2006, and will continue for 3.5 years. Participants are Japanese and foreign residents living in the intervention and control regions (a total of population of 2,120,000 individuals). The present study is designed to evaluate the effectiveness of the community-based suicide prevention program in the seven participating areas. UMIN Clinical Trials Registry (UMIN-CTR) UMIN000000460.

Management of Powdery Mildew in Squash by Plant and Alga Extract Biopesticides

PubMed Central

Zhang, Shouan; Mersha, Zelalem; Vallad, Gary E.; Huang, Cheng-Hua

2016-01-01

Although many fungicides are registered for use to control powdery mildew on cucurbits, management of resistance to fungicides in pathogen populations still remains a major challenge. Two biopesticides Regalia SC and HMO 736 were evaluated in the greenhouse and field for their efficacy against powdery mildew in squash. In greenhouses, Regalia SC alone significantly (P < 0.05) reduced powdery mildew compared to the nontreated control, and was as effective as the chemical standard Procure 480SC (triflumizole). In alternation with Procure 480SC, Regalia SC demonstrated greater or equivalent effects on reducing the disease. HMO 736 alone showed varying levels of disease control, but alternating with Procure 480SC significantly improved control efficacy. In addition, application of Regalia SC or HMO 736 each in alternation with Procure 480SC significantly increased the chlorophyll content in leaves and the total fresh weight of squash plants, when compared with the water control, Regalia SC and HMO 736 alone. In field trials, application of Regalia SC and HMO 736 each alone significantly reduced disease severity in one of two field trials during the early stage of disease development, but not during later stages when disease pressure became high. Both Regalia SC and HMO 736 each applied in alternation with Procure 480SC significantly improved the control efficacy compared to Procure 480SC alone. Results from this study demonstrated that an integrated management program can be developed for powdery mildew in squash by integrating the biopesticides Regalia SC, HMO 736 with the chemical fungicide Procure 480SC. PMID:27904459

Management of Powdery Mildew in Squash by Plant and Alga Extract Biopesticides.

PubMed

Zhang, Shouan; Mersha, Zelalem; Vallad, Gary E; Huang, Cheng-Hua

2016-12-01

Although many fungicides are registered for use to control powdery mildew on cucurbits, management of resistance to fungicides in pathogen populations still remains a major challenge. Two biopesticides Regalia SC and HMO 736 were evaluated in the greenhouse and field for their efficacy against powdery mildew in squash. In greenhouses, Regalia SC alone significantly ( P < 0.05) reduced powdery mildew compared to the nontreated control, and was as effective as the chemical standard Procure 480SC (triflumizole). In alternation with Procure 480SC, Regalia SC demonstrated greater or equivalent effects on reducing the disease. HMO 736 alone showed varying levels of disease control, but alternating with Procure 480SC significantly improved control efficacy. In addition, application of Regalia SC or HMO 736 each in alternation with Procure 480SC significantly increased the chlorophyll content in leaves and the total fresh weight of squash plants, when compared with the water control, Regalia SC and HMO 736 alone. In field trials, application of Regalia SC and HMO 736 each alone significantly reduced disease severity in one of two field trials during the early stage of disease development, but not during later stages when disease pressure became high. Both Regalia SC and HMO 736 each applied in alternation with Procure 480SC significantly improved the control efficacy compared to Procure 480SC alone. Results from this study demonstrated that an integrated management program can be developed for powdery mildew in squash by integrating the biopesticides Regalia SC, HMO 736 with the chemical fungicide Procure 480SC.

Mating Disruption of Planococcus ficus (Hemiptera: Pseudococcidae) in Vineyards Using Reservoir Pheromone Dispensers

PubMed Central

Cocco, Arturo; Lentini, Andrea; Serra, Giuseppe

2014-01-01

Abstract Mating disruption field experiments to control the vine mealybug, Planococcus ficus (Signoret) (Hemiptera: Pseudococcidae), were carried out in 2008 and 2009 in two commercial vineyards in Sardinia (Italy). The effectiveness of mating disruption was evaluated by testing reservoir dispensers loaded with 100 mg (62.5 g/ha) and 150 mg (93.8 g/ha) of the sex pheromone in 2008 and 2009, respectively. The number of males captured in pheromone traps, the P. ficus population density and age structure, the parasitism rate, the percentage of ovipositing females, and the crop damage were compared between disrupted and untreated plots. In both field trials, the number of males captured in mating disruption plots was significantly reduced by 86% and 95%, respectively. Mating disruption at the initial dose of 62.5 g/ha of active ingredient gave inconclusive results, whereas the dose of 93.8 g/ha significantly lowered the mealybug density and modified the age structure, which showed a lower percentage of ovipositing females and a higher proportion of preovipositing females. Mating disruption did not affect negatively the parasitism rate, which was higher in the disrupted than in the control plots (>1.5-fold). Crop damage at harvest was very low in both field trials and did not differ between treatments. Mating disruption was effective in wide plots protected with dispensers loaded with 150 mg of the sex pheromone, showing its potential to be included in the overall integrated control programs in Mediterranean wine-growing regions. PMID:25347835

Laboratory demonstration and field verification of a Wireless Cookstove Sensing System (WiCS) for determining cooking duration and fuel consumption

DOE PAGES

Graham, Eric A.; Patange, Omkar; Lukac, Martin; ...

2014-08-27

With improved cookstoves (ICs) increasingly distributed to households for a range of air pollution interventions and carbon-credit programs, it has become necessary to accurately monitor the duration of cooking and the amount of fuel consumed. In this study, laboratory trials were used to create temperature-based algorithms for quantifying cooking duration and estimating fuel consumption from stove temperatures. Field validation of the algorithms employed a Wireless Cookstove Sensing System (WiCS) that offers remote, low-cost temperature sensing and the wireless transmission of temperature data to a centralized database using local cellular networks. Field trials included 68 unscripted household cooking events. In themore » laboratory, temperature responses of the IC body and that of a removable temperature probe (J-bar) followed well-known physical models during cooking, indicating that location of the temperature sensor is not critical. In the laboratory, the classification correctly identified active cooking 97.2% of the time. In the field, the cooking duration was not statistically different from that recorded by trained volunteers; the average difference between calculated and observed cooking times was 0.03 ± 0.31 h (mean ± SD). In the laboratory, energy flux from the IC was calculated using temperatures measured by the J-bar and on the IC body and found to be proportional to the total energy in the consumed fuel, with an r 2 correlation value of 0.95. Here in the field, the average fuel consumption was calculated to be 0.97 ± 0.32 kg compared to that recorded by volunteers of 1.19 ± 0.37 kg with an average difference between calculated and observed fuel mass of 0.21 ± 0.37 kg per event. Finally, despite wide variation in observed cooking duration and fuel consumption per event, a relatively constant rate of fuel consumption of 0.48 kg h -1 was calculated for users of the same type of IC.« less

In pursuit of a science of agriculture: the role of statistics in field experiments.

PubMed

Parolini, Giuditta

2015-09-01

Since the beginning of the twentieth century statistics has reshaped the experimental cultures of agricultural research taking part in the subtle dialectic between the epistemic and the material that is proper to experimental systems. This transformation has become especially relevant in field trials and the paper will examine the British agricultural institution, Rothamsted Experimental Station, where statistical methods nowadays popular in the planning and analysis of field experiments were developed in the 1920s. At Rothamsted statistics promoted randomisation over systematic arrangements, factorisation over one-question trials, and emphasised the importance of the experimental error in assessing field trials. These changes in methodology transformed also the material culture of agricultural science, and a new body, the Field Plots Committee, was created to manage the field research of the agricultural institution. Although successful, the vision of field experimentation proposed by the Rothamsted statisticians was not unproblematic. Experimental scientists closely linked to the farming community questioned it in favour of a field research that could be more easily understood by farmers. The clash between the two agendas reveals how the role attributed to statistics in field experimentation defined different pursuits of agricultural research, alternately conceived of as a scientists' science or as a farmers' science.

State of the field survey: spinal cord stimulator use by academic pain medicine practices.

PubMed

Gharibo, Christopher; Laux, Gary; Forzani, Brian R; Sellars, Christopher; Kim, Eric; Zou, Shengping

2014-02-01

The concept of neuromodulation via the use of spinal cord stimulators (SCS) was first established over forty years ago. Since then, its popularity has grown as numerous studies have demonstrated its utility to reduce chronic pain, improve patient function, and reduce long-term health care costs. The aim of this study was to update the pain medicine community on the evolution of SCS practice trends in academic centers. Ninety-three pain medicine fellowship programs in the United States were identified from the Accreditation Council for Graduate Medical Education Website and were contacted to participate in an internet survey. A 37-item questionnaire was inspired by a previous study performed by Fanciullo et al. Questions focused on three main themes regarding SCS clinical application, namely demographics, education, and technical matters. Completed surveys were received from 50 institutions, all of which reported performing SCS interventions. Annual implants ranged from 0 to 150. Fellowship training was cited as the most valuable modality for learning implantation. Nearly all programs reported manufacturer representative participation during SCS procedures, with a minority of program directors discouraging their involvement in fellow education. SCS trials were performed exclusively on an outpatient basis. The average length for trials was 4-7 days. The most common indication for SCS implantation was failed back surgery syndrome, which also had the highest 2-year success rate. Post procedure, patients generally were followed up every 2-4 weeks for device reprogramming, which was performed by company representatives 92% of the time. Standardized SCS training is imperative as the implementation of neuromodulation therapy continues to increase. Wiley Periodicals, Inc.

Role of neonicotinyl insecticides in Washington apple integrated pest management. Part I. Control of lepidopteran pests

PubMed Central

Brunner, J. F.; Beers, E. H.; Dunley, J. E.; Doerr, M.; Granger, K.

2005-01-01

Three neonicotinyl insecticides, acetamiprid, thiacloprid and clothianidin, were evaluated for their impact on four species of lepidopteran pests of apple in Washington, the codling moth, Cydia pomonella (L.), the Pandemis leafroller, Pandemis pyrusana Kearfott, and the obliquebanded leafroller, Choristoneura rosaceana (Harris), and Lacanobia subjuncta (Grote & Robinson). None of the neonicotinyl insecticides demonstrated sufficient activity against P. pyrusana, C. rosaceana, or L. subjuncta to warrant field trials. Conversely, all had some activity against one or more stages of C. pomonella. Acetamiprid was highly toxic to larvae in laboratory bioassays, and had relatively long activity of field-aged residues (21 days). It also showed some toxicity to C. pomonella eggs (via topical exposure) and adults. Acetamiprid provided the highest level of fruit protection from C. pomonella attack in field trials conducted over five years in experimental orchards with extremely high codling moth pressure. Thiacloprid performed similarly in bioassays, but fruit protection in field trials was slightly lower than acetamiprid. Clothianidin showed moderate to high toxicity in bioassays, depending on the C. pomonella stage tested, but poor fruit protection from attack in field trials. None of the neonicotinyl insecticides were as toxic to larvae or effective in protecting fruit as the current standard organophosphate insecticide used for C. pomonella control, azinphosmethyl. However, both acetamiprid and thiacloprid should provide acceptable levels of C. pomonella control in commercial orchards where densities are much lower than in the experimental orchards used for our trials. The advantages and disadvantages of the neonicotinyl insecticides as replacements for the organophosphate insecticides and their role in a pest management system for Washington apple orchards are discussed. Abbreviation: MFR Maximum field rate PMID:16341246

Efficacy of a multimodal physiotherapy treatment program for hip osteoarthritis: a randomised placebo-controlled trial protocol

PubMed Central

2010-01-01

Background Hip osteoarthritis (OA) is a common condition leading to pain, disability and reduced quality of life. There is currently limited evidence to support the use of conservative, non-pharmacological treatments for hip OA. Exercise and manual therapy have both shown promise and are typically used together by physiotherapists to manage painful hip OA. The aim of this randomised controlled trial is to compare the efficacy of a physiotherapy treatment program with placebo treatment in reducing pain and improving physical function. Methods The trial will be conducted at the University of Melbourne Centre for Health, Exercise and Sports Medicine. 128 participants with hip pain greater or equal to 40/100 on visual analogue scale (VAS) and evidence of OA on x-ray will be recruited. Treatment will be provided by eight community physiotherapists in the Melbourne metropolitan region. The active physiotherapy treatment will comprise a semi-structured program of manual therapy and exercise plus education and advice. The placebo treatment will consist of sham ultrasound and the application of non-therapeutic gel. The participants and the study assessor will be blinded to the treatment allocation. Primary outcomes will be pain measured by VAS and physical function recorded on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) immediately after the 12 week intervention. Participants will also be followed up at 36 weeks post baseline. Conclusions The trial design has important strengths of reproducibility and reflecting contemporary physiotherapy practice. The findings from this randomised trial will provide evidence for the efficacy of a physiotherapy program for painful hip OA. Trial Registration Australian New Zealand Clinical Trials Registry reference: ACTRN12610000439044 PMID:20946621

Insecticide treated curtains and residual insecticide treatment to control Aedes aegypti: An acceptability study in Santiago de Cuba.

PubMed

Pérez, Dennis; Van der Stuyft, Patrick; Toledo, María Eugenia; Ceballos, Enrique; Fabré, Francisco; Lefèvre, Pierre

2018-01-01

Within the context of a field trial conducted by the Cuban vector control program (AaCP), we assessed acceptability of insecticide-treated curtains (ITCs) and residual insecticide treatment (RIT) with deltamethrin by the community. We also assessed the potential influence of interviewees' risk perceptions for getting dengue and disease severity. We embedded a qualitative study using in-depth interviews in a cluster randomized trial (CRT) testing the effectiveness of ITCs and RIT in Santiago de Cuba. In-depth interviews (N = 38) were conducted four and twelve months after deployment of the tools with people who accepted the tools, who stopped using them and who did not accept the tools. Data analysis was deductive. Main reasons for accepting ITCs at the start of the trial were perceived efficacy and not being harmful to health. Constraints linked to manufacturer instructions were the main reason for not using ITCs. People stopped using the ITCs due to perceived allergy, toxicity and low efficacy. Few heads of households refused RIT despite the noting reasons for rejection, such as allergy, health hazard and toxicity. Positive opinions of the vector control program influenced acceptability of both tools. However, frequent insecticide fogging as part of routine AaCP vector control actions diminished perceived efficacy of both tools and, therefore, acceptability. Fifty percent of interviewees did feel at risk for getting dengue and considered dengue a severe disease. However, this did not appear to influence acceptability of ITCs or RIT. Acceptability of ITCs and RIT was linked to acceptability of AaCP routine vector control activities. However, uptake and use were not always an indication of acceptability. Factors leading to acceptability may be best identified using qualitative methods, but more research is needed on the concept of acceptability and its measurement.

Methods to Prove 20+ Year Life of CPV Products (in less than 20 Years)

NASA Astrophysics Data System (ADS)

Bowman, John; Spencer, Mark

2011-12-01

Due to the long term life expectations of photovoltaic products and the short duration of most introduced CPV technologies, it is critical for CPV companies to carefully construct field trials to prove product life. Because of the complicated geometric, thermal, and spectral characteristics of CPV systems, conducting very precise power output measurements reproducibly over many months is very difficult. Robust normalization methods specific to the exact optical system and PV cell type must be developed. Once the performance over a specific duration, e.g. one year, is established, then some justification is required to extrapolate to future performance. Comparisons to accelerated test results provide this justification. SolFocus has been conducting field trials of the SF-1100S CPV system for over two years. These field trials consist of controlled populations of SF-1100P modules, operating in grid-tied systems, which have been repeatedly measured at the individual module level over the duration of the trials. In this paper, field data will be presented along with normalization methodology and statistical methods for determining power degradation slope distributions for populations of individual modules. These results will be correlated with accelerated field tests which have been ongoing for 1.5 years and are estimated to be equivalent to 10 to 15 years of non-accelerated operation.

Mindfulness Training and Reductions in Teacher Stress and Burnout: Results from Two Randomized, Waitlist-Control Field Trials

ERIC Educational Resources Information Center

Roeser, Robert W.; Schonert-Reichl, Kimberly A.; Jha, Amishi; Cullen, Margaret; Wallace, Linda; Wilensky, Rona; Oberle, Eva; Thomson, Kimberly; Taylor, Cynthia; Harrison, Jessica

2013-01-01

The effects of randomization to mindfulness training (MT) or to a waitlist-control condition on psychological and physiological indicators of teachers' occupational stress and burnout were examined in 2 field trials. The sample included 113 elementary and secondary school teachers (89% female) from Canada and the United States. Measures were…

Cucumber cultivars for container gardening and the value of field trials for predicting Cucumber performance in containers

USDA-ARS?s Scientific Manuscript database

Cucumber (Cucumis sativus L.) is one of the most popular vegetable crops grown in U.S. home and urban gardens. The objectives of this study were to identify cultivars and planting densities for high yield of container-grown cucumbers. Additional objectives were to determine the value of field trials...

A Multisite Cluster Randomized Field Trial of Open Court Reading

ERIC Educational Resources Information Center

Borman, Geoffrey D.; Dowling, N. Maritza; Schneck, Carrie

2008-01-01

In this article, the authors report achievement outcomes of a multisite cluster randomized field trial of Open Court Reading 2005 (OCR), a K-6 literacy curriculum published by SRA/McGraw-Hill. The participants are 49 first-grade through fifth-grade classrooms from predominantly minority and poor contexts across the nation. Blocking by grade level…

[Microdose clinical trial--impact of PET molecular imaging].

PubMed

Yano, Tsuneo; Watanabe, Yasuyoshi

2010-10-01

Microdose (MD) clinical trial and exploratory IND study including sub-therapeutic dose and therapeutic dose which are higher than microdoses are expected to bring about innovations in drug development. The outlines of guidances for microdose clinical trial and ICH-M3 (R2) issued by the MHLW in June, 2008, and February, 2010, are first explained, respectively, and some examples of their application to clinical developments of therapeutic drugs in the infection and cancer fields are introduced. Especially, thanks to the progress of molecular imaging research, a new field of drug development is explored by using imaging biomarkers for efficacy or safety evaluation which visualize biomarkers by PET imaging agents. Finally, the roadmap for drug development in infection and cancer fields utilizing PET molecular imaging is discussed.

Promoting resilience in youth from divorced families: lessons learned from experimental trials of the New Beginnings Program.

PubMed

Wolchik, Sharlene A; Schenck, Clorinda E; Sandler, Irwin N

2009-12-01

This article focuses on the contributions that the program of research on the New Beginnings Program (NBP) has made to understanding pathways to resilience in youth who experience parental divorce. First, the research demonstrating that divorce increases risk for mental health, physical health, and social adaptation problems is reviewed. Next, theory and research linking social environmental-level and youth-level modifiable risk factors and resilience resources to youth's postdivorce adjustment are presented. The conceptual framework underlying the NBP and the risk factors and resilience resources targeted in this program are described next. The short-term and long-term results of two experimental, randomized efficacy trials of the NBP and moderators and mediators of its effects are then presented. Analyses that examine whether youth self-systems beliefs account for the links between program-induced changes in family-level resilience resources and positive long-term program on adaptation outcomes are presented and how experimental trials can be used to further theories of resilience for youth facing adversities is discussed. The final section describes directions for future research on the NBP.

Promoting Resilience in Youth from Divorced Families: Lessons Learned from Experimental Trials of the New Beginnings Program

PubMed Central

Wolchik, Sharlene A.; Schenck, Clorinda E.; Sandler, Irwin N.

2009-01-01

This article focuses on the contributions that the program of research on the New Beginnings Program (NBP) has made to understanding pathways to resilience in youth who experience parental divorce. First, the research demonstrating that divorce increases risk for mental health, physical health and social adaptation problems is reviewed. Next, theory and research linking social environmental-level and youth-level modifiable risk factors and resilience resources to youth’s post-divorce adjustment are presented. The conceptual framework underlying the NBP and the risk factors and resilience resources targeted in this program are described next. The short-term and long-term results of two experimental, randomized efficacy trials of the NBP and moderators and mediators of its effects are then presented. Analyses that examine whether youth self-systems beliefs account for the links between program-induced changes in family-level resilience resources and positive long-term program on adaptation outcomes are presented and how experimental trials can be used to further theories of resilience for youth facing adversities is discussed. The final section describes directions for future research on the NBP. PMID:19807862

Engaging rural women in healthy lifestyle programs: insights from a randomized controlled trial.

PubMed

Kozica, Samantha L; Harrison, Cheryce L; Teede, Helena J; Ng, Sze; Moran, Lisa J; Lombard, Catherine B

2015-09-16

The obesity epidemic is well established, particularly in rural settings. Programs promoting healthy lifestyles for rural women are urgently needed; however, participant engagement is challenging. In the context of a large randomized controlled trial targeting the prevention of weight gain in rural women, we explored successful recruitment strategies and aimed to understand participants' barriers, enablers and reasons for program participation. We recruited women (aged 18-55 years) from the general rural Australian population. A mixed-methods approach was applied to explore factors that influenced program participation, including quantitative questionnaires for all participants (n = 649) and qualitative semi-structured interviews conducted for a subgroup of participants (n = 45). Data were collected at three time points: baseline, 6 and 12 months post program commencement. We recruited 649 rural women through a community communication and partnering strategy, a program marketing campaign and mobilization of social networks. Program participants were diverse across education and income levels and were representative of the wider Australian regional population. Factors that influenced program engagement were divided into personal (perceived program benefits and program accessibility) and social (peer persuasion and support). Identified enablers included convenience of the program location, perceived program utility, such as weight management and optimization of lifestyle choices, as well as attending the program with peer support. Barriers to engagement, which are likely exacerbated in rural communities included lack of anonymity, self-consciousness and segregated social networks in rural settings. Participants reported that eliciting local support and maximizing publicity is fundamental to improving future program engagement. Multiple program promotion strategies including communication, marketing and partnering, as well as mobilization of social networks and peer persuasion, enabled engagement of rural women into a healthy lifestyle program. These recruitment strategies are consistent with successful strategies utilized previously to recruit urban-dwelling women into lifestyle programs. Future engagement efforts in rural settings could be enhanced by hosting multiple sessions within existing socio-cultural networks and assuring participants that they will not need to share their personal health information with others in their community. Australia & New Zealand Clinical Trial Registry. Trial number ACTRN12612000115831. Date of registration 24 January 2012.

A mobile phone-based care model for outpatient cardiac rehabilitation: the care assessment platform (CAP)

PubMed Central

2010-01-01

Background Cardiac rehabilitation programs offer effective means to prevent recurrence of a cardiac event, but poor uptake of current programs have been reported globally. Home based models are considered as a feasible alternative to avoid various barriers related to care centre based programs. This paper sets out the study design for a clinical trial seeking to test the hypothesis that these programs can be better and more efficiently supported with novel Information and Communication Technologies (ICT). Methods/Design We have integrated mobile phones and web services into a comprehensive home- based care model for outpatient cardiac rehabilitation. Mobile phones with a built-in accelerometer sensor are used to measure physical exercise and WellnessDiary software is used to collect information on patients' physiological risk factors and other health information. Video and teleconferencing are used for mentoring sessions aiming at behavioural modifications through goal setting. The mentors use web-portal to facilitate personal goal setting and to assess the progress of each patient in the program. Educational multimedia content are stored or transferred via messaging systems to the patients phone to be viewed on demand. We have designed a randomised controlled trial to compare the health outcomes and cost efficiency of the proposed model with a traditional community based rehabilitation program. The main outcome measure is adherence to physical exercise guidelines. Discussion The study will provide evidence on using mobile phones and web services for mentoring and self management in a home-based care model targeting sustainable behavioural modifications in cardiac rehabilitation patients. Trial registration The trial has been registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) with number ACTRN12609000251224. PMID:20109196

Efficacy of smoking prevention program 'Smoke-free Kids': study protocol of a randomized controlled trial

PubMed Central

2009-01-01

Background A strong increase in smoking is noted especially among adolescents. In the Netherlands, about 5% of all 10-year olds, 25% of all 13-year olds and 62% of all 17-year olds report ever smoking. In the U.S., an intervention program called 'Smoke-free Kids' was developed to prevent children from smoking. The present study aims to assess the effects of this home-based smoking prevention program in the Netherlands. Methods/Design A randomized controlled trial is conducted among 9 to 11-year old children of primary schools. Participants are randomly assigned to the intervention and control conditions. The intervention program consists of five printed activity modules designed to improve parenting skills specific to smoking prevention and parent-child communication regarding smoking. These modules will include additional sheets with communication tips. The modules for the control condition will include solely information on smoking and tobacco use. Initiation of cigarette smoking (first instance of puffing on a lighted cigarette), susceptibility to cigarette smoking, smoking-related cognitions, and anti-smoking socialization will be the outcome measures. To collect the data, telephone interviews with mothers as well as with their child will be conducted at baseline. Only the children will be examined at post-intervention follow-ups (6, 12, 24, and 36 months after the baseline). Discussion This study protocol describes the design of a randomized controlled trial that will evaluate the effectiveness of a home-based smoking prevention program. We expect that a significantly lower number of children will start smoking in the intervention condition compared to control condition as a direct result of this intervention. If the program is effective, it is applicable in daily live, which will facilitate implementation of the prevention protocol. Trial registration Netherlands Trial Register NTR1465 PMID:20025727

Advanced ASON prototyping research activities in China

NASA Astrophysics Data System (ADS)

Hu, WeiSheng; Jin, Yaohui; Guo, Wei; Su, Yikai; He, Hao; Sun, Weiqiang

2005-02-01

This paper provides an overview of prototyping research activities of automatically switched optical networks and transport networks (ASONs/ASTNs) in China. In recent years, China has recognized the importance and benefits of the emerging ASON/ASTN techniques. During the period of 2001 and 2002, the national 863 Program of China started the preliminary ASON research projects with the main objectives to build preliminary ASON testbeds, develop control plane protocols and test their performance in the testbeds. During the period of 2003 and 2004, the 863 program started ASTN prototyping equipment projects for more practical applications. Totally 12 ASTN equipments are being developed by three groups led by Chinese venders: ZTE with Beijing University of Posts and Telecommunications (BUPT), Wuhan Research Institute of Posts and Telecommunication (WRI) with Shanghai Jiao Tong University (SJTU), and Huawei Inc. Meanwhile, as the ASTN is maturing, some of the China"s carries are participating in the OIF"s World Interoperability Demonstration, carrying out ASTN test, or deploying ASTN backbone networks. Finally, several ASTN backbone networks being tested or deployed now will be operated by the carries in 2005. The 863 Program will carry out an ASTN field trail in Yangtse River Delta, and finally deploy the 3TNET. 3TNET stands for Tbps transmission, Tbps switching, and Tbps routing, as well as a network integrating the above techniques. A task force under the "863" program is responsible for ASTN equipment specifications and interoperation agreements, technical coordination among all the participants, schedule of the whole project during the project undergoing, and organization of internetworking of all the equipments in the laboratories and field trials.

Comparative impacts of Tai Chi, balance training, and a specially-designed yoga program on balance in older fallers.

PubMed

Ni, Meng; Mooney, Kiersten; Richards, Luca; Balachandran, Anoop; Sun, Mingwei; Harriell, Kysha; Potiaumpai, Melanie; Signorile, Joseph F

2014-09-01

To compare the effect of a custom-designed yoga program with 2 other balance training programs. Randomized controlled trial. Research laboratory. A group of older adults (N=39; mean age, 74.15 ± 6.99 y) with a history of falling. Three different exercise interventions (Tai Chi, standard balance training, yoga) were given for 12 weeks. Balance performance was examined during pre- and posttest using field tests, including the 8-foot up-and-go test, 1-leg stance, functional reach, and usual and maximal walking speed. The static and dynamic balances were also assessed by postural sway and dynamic posturography, respectively. Training produced significant improvements in all field tests (P<.005), but group difference and time × group interaction were not detected. For postural sway, significant decreases in the area of the center of pressure with eyes open (P=.001) and eyes closed (P=.002) were detected after training. For eyes open, maximum medial-lateral velocity significantly decreased for the sample (P=.013). For eyes closed, medial-lateral displacement decreased for Tai Chi (P<.01). For dynamic posturography, significant improvements in overall score (P=.001), time on the test (P=.006), and 2 linear measures in lateral (P=.001) and anterior-posterior (P<.001) directions were seen for the sample. Yoga was as effective as Tai Chi and standard balance training for improving postural stability and may offer an alternative to more traditional programs. Copyright © 2014 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Randomized Trial of Healthy Families Arizona: Quantitative and Qualitative Outcomes

ERIC Educational Resources Information Center

LeCroy, Craig Winston; Davis, Melinda F.

2017-01-01

Home visitation has the potential to improve parent, child, and maternal outcomes and has become a widely implemented prevention program across the United States. The purpose of this research was to use a randomized controlled trial to assess the short-term effectiveness of the Arizona Healthy Families program across a range of outcomes. Two…

DARTTS Diagnostic Assessments of Reading with Trial Teaching Strategies: Administrator's Summary. Report No. 9-49040.

ERIC Educational Resources Information Center

Riverside Publishing Co., Chicago. IL.

The Diagnostic Assessments of Reading with Trial Teaching Strategies (DARTTS) is a program of diagnostic tests with sample lessons in aspects of literacy. Developed by Florence G. Roswell and Jeanne S. Chall, the DARTTS program is published in a multilevel format for beginning through advanced (high school) readers. Teachers administer and score…

Alcohol Prevention and School Students: Findings from an Australian 2-Year Trial of Integrated Harm Minimization School Drug Education

ERIC Educational Resources Information Center

Midford, Richard; Ramsden, Robyn; Lester, Leanne; Cahill, Helen; Mitchell, Johanna; Foxcroft, David R.; Venning, Lynne

2014-01-01

The Drug Education in Victorian Schools program provided integrated education about licit and illicit drugs, employed a harm minimization approach that incorporated participatory, critical thinking and skill-based teaching methods, and engaged parental influence through home activities. A cluster-randomized, controlled trial of the program was…

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

ERIC Educational Resources Information Center

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

2014-01-01

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

Retention in a Breast Cancer Risk Information Trial: Motivations of a Population-Based Sample of Women

ERIC Educational Resources Information Center

Ariail, Kiley; Watts, Carolyn; Bowen, Deborah J.

2006-01-01

A better understanding of factors influencing retention in breast cancer risk education and prevention programs can improve the design and effectiveness of such programs. Such information may also be useful to researchers seeking to maximize full retention in research trials involving low risk and low perceived benefit by the participants. These…

Puerto Rico NCI Community Oncology Research Program Minority/Underserved | Division of Cancer Prevention

Cancer.gov

The Puerto Rico NCI Community Oncology Research Program (PRNCORP) will be the principal organization in the island that promotes cancer prevention, control and screening/post-treatment surveillance clinical trials. It will conduct cancer care delivery research and will provide access to treatment and imaging clinical trials conducted under the reorganization of the National

The Special Supplemental Nutrition Program for Women, Infants, and Children Fresh Start randomized controlled trial: Baseline participant characteristics and reliability of measures

USDA-ARS?s Scientific Manuscript database

The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) Fresh Start (WFS) is a randomized controlled trial of nutrition education to promote farmers' market fruit and vegetable (F/V) purchases and consumption among women enrolled in WIC. Our objectives were to describe the ...

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…

Tuning in to Kids: An Emotion-Focused Parenting Program--Initial Findings from a Community Trial

ERIC Educational Resources Information Center

Havighurst, Sophie S.; Wilson, Katherine R.; Harley, Ann E.; Prior, Margot R.

2009-01-01

This study evaluated a new group parenting program, Tuning in to Kids, which taught emotion coaching skills to parents of preschool children. In a randomized control trial, 218 primary caregiver parents of children aged 4.0-5.11 years completed questionnaires assessing parent emotion socialization (emotion coaching vs. emotion dismissing), parent…

Sustainability of the Dissemination of an Occupational Sun Protection Program in a Randomized Trial

ERIC Educational Resources Information Center

Buller, David B.; Walkosz, Barbara J.; Andersen, Peter A.; Scott, Michael D.; Dignan, Mark B.; Cutter, Gary R.; Zhang, Xiao; Kane, Ilima L.

2012-01-01

Sustainability of an occupational sun safety program, Go Sun Smart (GSS), was explored in a randomized trial, testing dissemination strategies at 68 U.S. and Canadian ski areas in 2004-2007. All ski areas received GSS from the National Ski Areas Association through a Basic Dissemination Strategy (BDS) using conference presentations and free…

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

ERIC Educational Resources Information Center

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

2014-01-01

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

Effectiveness of a Therapeutic Summer Camp for Children with ADHD: Phase I Clinical Intervention Trial

ERIC Educational Resources Information Center

Hantson, Julie; Wang, Pan Pan; Grizenko-Vida, Michael; Ter-Stepanian, Marina; Harvey, William; Joober, Ridha; Grizenko, Natalie

2012-01-01

Objective: The objective of this study was to evaluate the effectiveness of a 2-week therapeutic summer day camp for children with ADHD, which included a social skills training program and parent psychoeducation and training program. This was an open-label, nonrandomized Phase I Clinical Intervention Trial. Method: Parents completed the Weiss…

Lidcombe Program Webcam Treatment for Early Stuttering: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Bridgman, Kate; Onslow, Mark; O'Brian, Susan; Jones, Mark; Block, Susan

2016-01-01

Purpose: Webcam treatment is potentially useful for health care in cases of early stuttering in which clients are isolated from specialized treatment services for geographic and other reasons. The purpose of the present trial was to compare outcomes of clinic and webcam deliveries of the Lidcombe Program treatment (Packman et al., 2015) for early…

Impact of a Parenting Program in a High-Risk, Multi-Ethnic Community: The PALS Trial

ERIC Educational Resources Information Center

Scott, Stephen; O'Connor, Thomas G.; Futh, Annabel; Matias, Carla; Price, Jenny; Doolan, Moira

2010-01-01

Background: Parenting programs have been shown to work when delivered to motivated ethnic majority parents in demonstration projects, but comparatively little is known about their impact when delivered to high-risk, multi-ethnic populations by routine local services. Methods: The Primary Age Learning Skills (PALS) trial was a randomized controlled…

Improving Classroom Learning Environments by Cultivating Awareness and Resilience in Education (CARE): Results of a Randomized Controlled Trial

ERIC Educational Resources Information Center

Jennings, Patricia A.; Frank, Jennifer L.; Snowberg, Karin E.; Coccia, Michael A.; Greenberg, Mark T.

2013-01-01

Cultivating Awareness and Resilience in Education (CARE for Teachers) is a mindfulness-based professional development program designed to reduce stress and improve teachers' performance and classroom learning environments. A randomized controlled trial examined program efficacy and acceptability among a sample of 50 teachers randomly assigned to…

Randomized Trials on Consider This, a Tailored, Internet-Delivered Smoking Prevention Program for Adolescents

ERIC Educational Resources Information Center

Buller, David B.; Borland, Ron; Woodall, W. Gill; Hall, John R.; Hines, Joan M.; Burris-Woodall, Patricia; Cutter, Gary R.; Miller, Caroline; Balmford, James; Starling, Randall; Ax, Bryan; Saba, Laura

2008-01-01

The Internet may be an effective medium for delivering smoking prevention to children. Consider This, an Internet-based program, was hypothesized to reduce expectations concerning smoking and smoking prevalence. Group-randomized pretest-posttest controlled trials were conducted in Australia (n = 2,077) and the United States (n = 1,234) in schools…

Children's Healthy Living (CHL) Program for remote underserved minority populations in the Pacific region: rationale and design of a community randomized trial to prevent early childhood obesity.

PubMed

Wilken, Lynne R; Novotny, Rachel; Fialkowski, Marie K; Boushey, Carol J; Nigg, Claudio; Paulino, Yvette; Leon Guerrero, Rachael; Bersamin, Andrea; Vargo, Don; Kim, Jang; Deenik, Jonathan

2013-10-09

Although surveillance data are limited in the US Affiliated Pacific, Alaska, and Hawaii, existing data suggest that the prevalence of childhood obesity is similar to or in excess of other minority groups in the contiguous US. Strategies for addressing the childhood obesity epidemic in the region support the use of community-based, environmentally targeted interventions. The Children's Healthy Living Program is a partnership formed across institutions in the US Affiliated Pacific, Alaska, and Hawaii to design a community randomized environmental intervention trial and a prevalence survey to address childhood obesity in the region through affecting the food and physical activity environment. The Children's Healthy Living Program community randomized trial is an environmental intervention trial in four matched-pair communities in American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, and Hawaii and two matched-pair communities in Alaska. A cross-sectional sample of children (goal n = 180) in each of the intervention trial communities is being assessed for outcomes at baseline and at 24 months (18 months post-intervention). In addition to the collection of the participant-based measures of anthropometry, diet, physical activity, sleep and acanthosis nigricans, community assessments are also being conducted in intervention trial communities. The Freely Associated States of Micronesia (Federated States of Micronesia, and Republics of Marshall Islands and Palau) is only conducting elements of the Children's Healthy Living Program sampling framework and similar measurements to provide prevalence data. In addition, anthropometry information will be collected for two additional communities in each of the 5 intervention jurisdictions to be included in the prevalence survey. The effectiveness of the environmental intervention trial is being assessed based on the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework. The Children's Healthy Living Program environmental trial is designed to focus on capacity building and to maximize the likelihood of sustainable impact on childhood obesity-related behaviors and outcomes. The multiple measures at the individual, community, and environment levels are designed to maximize the likelihood of detecting change. This approach enhances the likelihood for identifying and promoting the best methods to promote health and well-being of the children in the underserved US Affiliated Pacific Region. NIH clinical trial # NCT01881373.

The effectiveness of a trauma-focused psycho-educational secondary prevention program for children exposed to interparental violence: study protocol for a randomized controlled trial

PubMed Central

2012-01-01

Background Children who witness interparental violence are at a heightened risk for developing psychosocial, behavioral and cognitive problems, as well as posttraumatic stress symptoms. For these children the psycho-educational secondary prevention program 'En nu ik...!' ('It's my turn now!') has been developed. This program includes specific therapeutic factors focused on emotion awareness and expression, increasing feelings of emotional security, teaching specific coping strategies, developing a trauma narrative, improving parent-child interaction and psycho-education. The main study aim is to evaluate the effectiveness of the specific therapeutic factors in the program. A secondary objective is to study mediating and moderating factors. Methods/design This study is a prospective multicenter randomized controlled trial across cities in the Netherlands. Participants (N = 140) are referred to the secondary preventive intervention program by police, social work, women shelters and youth (mental health) care. Children, aged 6-12 years, and their parents, who experienced interparental violence are randomly assigned to either the intervention program or the control program. The control program is comparable on nonspecific factors by offering positive attention, positive expectations, recreation, distraction, warmth and empathy of the therapist, and social support among group participants, in ways that are similar to the intervention program. Primary outcome measures are posttraumatic stress symptoms and emotional and behavioral problems of the child. Mediators tested are the ability to differentiate and express emotions, emotional security, coping strategies, feelings of guilt and parent-child interaction. Mental health of the parent, parenting stress, disturbances in parent-child attachment, duration and severity of the domestic violence and demographics are examined for their moderating effect. Data are collected one week before the program starts (T1), and one week (T2) and six months (T3) after finishing the program. Both intention-to-treat and completer analyses will be done. Discussion Adverse outcomes after witnessing interparental violence are highly diverse and may be explained by multiple risk factors. An important question for prevention programs is therefore to what extent a specific focus on potential psychotrauma is useful. This trial may point to several directions for optimizing public health response to children's exposure to interparental violence. Trial registration Netherlands Trial Register (NTR): NTR3064 PMID:22309641

Effects of exercise and horticultural intervention on the brain and mental health in older adults with depressive symptoms and memory problems: study protocol for a randomized controlled trial [UMIN000018547].

PubMed

Makizako, Hyuma; Tsutsumimoto, Kota; Doi, Takehiko; Hotta, Ryo; Nakakubo, Sho; Liu-Ambrose, Teresa; Shimada, Hiroyuki

2015-11-04

Depressive symptoms and memory problems are significant risk factors for dementia. Exercise can reduce depressive symptoms and improve cognitive function in older people. In addition, the benefits of horticultural activity on physical and mental well-being have been demonstrated in people with dementia. Although evidence of such non-pharmacological interventions is mounting, no studies have examined whether physical exercise and horticultural activity exert a positive impact on brain and mental health (e.g., depressive symptoms) in non-demented older adults at high risk of cognitive impairment and depression. Therefore, we propose a randomized controlled trial to assess the efficacy and efficiency of physical exercise and horticultural activity in improving brain and mental health in community-dwelling older adults with memory problems and depressive symptoms. The 20-week randomized controlled trial will include 90 community-dwelling adults aged 65 years or older with memory problems and depressive symptoms. Participants will be randomized to one of three experiments: exercise, horticultural activity, or educational control group, using a 1:1:1 allocation ratio. The combined exercise program and horticultural activity program will consist of 20 weekly 90-minute sessions. Participants in the exercise group will practice aerobic exercise, muscle strength training, postural balance retraining, and dual-task training. The horticultural activity program will include crop-related activities, such as field cultivation, growing, and harvesting. Participants in the educational control group will attend two 90-minute educational classes during the 6-month trial period. Depressive symptoms and memory performance will be measured by the Geriatric Depression Scale-15, and the Logical Memory subtests of the Wechsler Memory Scale-Revised will be used to measure depressive symptoms and memory performance as primary outcomes, at baseline (prior to randomization), immediately following intervention (6 months from baseline), and 6 months after intervention. Hippocampal volume will be measured at baseline and immediately after intervention, using magnetic resonance imaging. Secondary outcomes will comprise cognitive function, including language, attention/executive performance, and processing speed; brain-derived neurotrophic-factor serum levels; and health-related quality of life. This intervention study will determine the clinical importance and efficacy of physical exercise and horticultural activity as non-pharmacological interventions in community-dwelling older adults at high risk of poor brain and mental health. UMIN000018547 ; registered 7 August 2015.

Efficacy of a 3 month training program on the jump-landing technique in jump-landing sports. Design of a cluster randomized controlled trial

PubMed Central

2010-01-01

Background With the relatively high rate of injuries to the lower extremity due to jump-landing movement patterns and the accompanied high costs, there is need for determining potential preventive programs. A program on the intervention of jump-landing technique is possibly an important preventative measure since it appeared to reduce the incidence of lower extremity injuries. In real life situations, amateur sports lack the infrastructure and funds to have a sports physician or therapist permanently supervising such a program. Therefore the current prevention program is designed so that it could be implemented by coaches alone. Objective The objective of this randomized controlled trial is to evaluate the effect of a coach supervised intervention program targeting jump-landing technique on the incidence of lower extremity injuries. Methods Of the 110 Flemish teams of the elite division, 24 teams are included and equally randomized to two study groups. An equal selection of female and male teams with allocation to intervention and control group is obtained. The program is a modification of other prevention programs previously proven to be effective. All exercises in the current program are adjusted so that a more progressive development in the exercise is presented. Both the control and intervention group continue with their normal training routine, while the intervention group carries out the program on jump-landing technique. The full intervention program has a duration of three months and is performed 2 times a week during warm-up (5-10 min). Injuries are registered during the entire season. Discussion The results of this study can give valuable information on the effect of a coach supervised intervention program on jump-landing technique and injury occurrence. Results will become available in 2011. Trial registration Trial registration number: NTR2560 PMID:21144030

The Swedish six-community alcohol and drug prevention trial: effects on youth drinking.

PubMed

Hallgren, Mats; Andréasson, Sven

2013-09-01

Local communities are increasingly targeted for alcohol and drug prevention campaigns. This study describes some of the key findings from the Swedish six-community alcohol and drug prevention trial (2003-2007) and lessons learned following an evaluation of the trial's effectiveness. The paper focuses mainly on changes in youth drinking and related harms. This was a pre- to post-intervention effect study comparing six trial communities that received added training and technical support with six control communities where regular prevention efforts were supported by national alcohol and drug action plans. A repeated, cross-sectional survey of 8092 youths aged 15-19 years assessed changes in alcohol consumption, binge drinking, perceived alcohol availability, access to alcohol via parents and adult attitudes towards the supply of alcohol to youths. National registry data were used to assess changes in hospital admissions due to alcohol intoxication. Overall, there were few significant improvements in the six trial communities compared with the control communities. The absence of program effects was largely attributable to the selection of strategies (in particular, school and parental programs) lacking evidence of effectiveness in reducing alcohol consumption at the aggregate level. Prevention programs based on efficacy studies need to be tested in community-based effectiveness trials before being disseminated. © 2013 Australasian Professional Society on Alcohol and other Drugs.

Randomization in cancer clinical trials: permutation test and development of a computer program.

PubMed Central

Ohashi, Y

1990-01-01

When analyzing cancer clinical trial data where the treatment allocation is done using dynamic balancing methods such as the minimization method for balancing the distribution of important prognostic factors in each arm, conservativeness occurs if such a randomization scheme is ignored and a simple unstratified analysis is carried out. In this paper, the above conservativeness is demonstrated by computer simulation, and the development of a computer program that carries out permutation tests of the log-rank statistics for clinical trial data where the allocation is done by the minimization method or a stratified permuted block design is introduced. We are planning to use this program in practice to supplement a usual stratified analysis and model-based methods such as the Cox regression. The most serious problem in cancer clinical trials in Japan is how to carry out the quality control or data management in trials that are initiated and conducted by researchers without support from pharmaceutical companies. In the final section of this paper, one international collaborative work for developing international guidelines on data management in clinical trials of bladder cancer is briefly introduced, and the differences between the system adopted in US/European statistical centers and the Japanese system is described. PMID:2269216

Taking Working Memory Training from the Laboratory into Schools

ERIC Educational Resources Information Center

Holmes, Joni; Gathercole, Susan Elizabeth

2014-01-01

Working memory skills have been shown to be enhanced by adaptive training in several randomised controlled trials. Here, two field trials were conducted in which teachers administered working memory training to their own pupils in school. Twenty-two children aged 8-9?years participated in Trial 1. In Trial 2, 50 children aged 9-11?years with the…

Stem Cell Trials for Cardiovascular Medicine: Ethical Rationale

PubMed Central

Teraa, Martin; Hesam, Husna; van Delden, Johannes J.M.; Verhaar, Marianne C.; Bredenoord, Annelien L.

2014-01-01

Stem cell-based interventions provide new treatment prospects for many disease conditions, including cardiovascular disorders. Clinical trials are necessary to collect adequate evidence on (long-term) safety and efficacy of novel interventions such as stem cells, but the design and launch of clinical trials, from first-in-human studies to larger randomized controlled trials (RCTs), is scientifically and ethically challenging. Stem cells are different from traditional pharmaceuticals, surgical procedures, and medical devices in the following ways: the novelty and complexity of stem cells, the invasiveness of the procedures, and the novel aim of regeneration. These specifics, combined with the characteristics of the study population, will have an impact on the design and ethics of RCTs. The recently closed JUVENTAS trial will serve as an example to identify the (interwoven) scientific and ethical challenges in the design and launch of stem cell RCTs. The JUVENTAS trial has investigated the efficacy of autologous bone marrow cells in end-stage vascular patients, in a double-blind sham-controlled design. We first describe the choices, considerations, and experiences of the JUVENTAS team. Subsequently, we identify the main ethical and scientific challenges and discuss what is important to consider in the design of future stem cell RCTs: assessment of risks and benefits, the choice for outcome measures, the choice for the comparator, the appropriate selection of participants, and adequate informed consent. Additionally, the stem cell field is highly in the spotlight due to the (commercial) interests and expectations. This warrants a cautious pace of translation and scrupulous set up of clinical trials, as failures could put the field in a negative light. At the same time, knowledge from clinical trials is necessary for the field to progress. We conclude that in the scientifically and ethically challenging field of stem cell RCTs, researchers and clinicians have to maneuver between the Skylla of hyper accelerated translation without rigorously conducted RCTs and the Charybdis of the missed opportunity of valuable knowledge. PMID:24164351

Telling our stories: heroin-assisted treatment and SNAP activism in the Downtown Eastside of Vancouver.

PubMed

Boyd, Susan; Murray, Dave; MacPherson, Donald

2017-05-18

This article highlights the experiences of a peer-run group, SALOME/NAOMI Association of Patients (SNAP), that meets weekly in the Downtown Eastside of Vancouver, British Columbia, Canada. SNAP is a unique independent peer- run drug user group that formed in 2011 following Canada's first heroin-assisted treatment trial (HAT), North America Opiate Medication Initiative (NAOMI). SNAP's members are now made up of former research participants who participated in two heroin-assisted trials in Vancouver. This article highlights SNAP members' experiences as research subjects in Canada's second clinical trial conducted in Vancouver, Study to Assess Longer-term Opioid Medication Effectiveness (SALOME), that began recruitment of research participants in 2011. This paper draws on one brainstorming session, three focus groups, and field notes, with the SALOME/NAOMI Association of Patients (SNAP) in late 2013 about their experiences as research subjects in Canada's second clinical trial, SALOME in the DTES of Vancouver, and fieldwork from a 6-year period (March 2011 to February 2017) with SNAP members. SNAP's research draws on research principles developed by drug user groups and critical methodological frameworks on community-based research for social justice. The results illuminate how participating in the SALOME clinical trial impacted the lives of SNAP members. In addition, the findings reveal how SNAP member's advocacy for HAT impacts the group in positive ways. Seven major themes emerged from the analysis of the brainstorming and focus groups: life prior to SALOME, the clinic setting and routine, stability, 6-month transition, support, exiting the trial and ethics, and collective action, including their participation in a constitutional challenge in the Supreme Court of BC to continue receiving HAT once the SALOME trial ended. HAT benefits SNAP members. They argue that permanent HAT programs should be established in Canada because they are an effective harm reduction initiative, one that also reduces opioid overdose deaths.

Comparative effect of integrated pest management and farmers' standard pest control practice for managing insect pests on cabbage (Brassica spp.).

PubMed

Reddy, Gadi V P

2011-08-01

Studies were conducted on experimental cabbage plantings in 2009 and on experimental and commercial plantings in 2010, comparing farmers' current chemical standard pesticide practices with an integrated pest management (IPM) program based on the use of neem (Aza-Direct) and DiPel (Bacillus thuringiensis). In experimental plantings, the IPM program used six or eight applications of neem and DiPel on a rotational basis. The standard-practice treatments consisted of six or eight applications of carbaryl and malathion or control treatment. The IPM treatments reduced pest populations and damage, resulting in a better yield than with the standard chemical or control treatment. When IPM treatment included three applications of neem plus three applications of DiPel (on a rotational basis in experimental fields), it again reduced the pest population and damage and produced a better yield than the standard practice. The lower input costs of the IPM program resulted in better economic returns in both trials. The IPM components neem and DiPel are suitable for use in an IPM program for managing insect pests on cabbage (Brassica spp.). Copyright © 2011 Society of Chemical Industry.

Randomized Trial of Two Dissemination Strategies for a Skin Cancer Prevention Program in Aquatic Settings

PubMed Central

Escoffery, Cam; Elliott, Tom; Nehl, Eric J.

2015-01-01

Objectives. We compared 2 strategies for disseminating an evidence-based skin cancer prevention program. Methods. We evaluated the effects of 2 strategies (basic vs enhanced) for dissemination of the Pool Cool skin cancer prevention program in outdoor swimming pools on (1) program implementation, maintenance, and sustainability and (2) improvements in organizational and environmental supports for sun protection. The trial used a cluster-randomized design with pools as the unit of intervention and outcome. The enhanced group received extra incentives, reinforcement, feedback, and skill-building guidance. Surveys were collected in successive years (2003–2006) from managers of 435 pools in 33 metropolitan areas across the United States participating in the Pool Cool Diffusion Trial. Results. Both treatment groups improved their implementation of the program, but pools in the enhanced condition had significantly greater overall maintenance of the program over 3 summers of participation. Furthermore, pools in the enhanced condition established and maintained significantly greater sun-safety policies and supportive environments over time. Conclusions. This study found that more intensive, theory-driven dissemination strategies can significantly enhance program implementation and maintenance of health-promoting environmental and policy changes. Future research is warranted through longitudinal follow-up to examine sustainability. PMID:25521872

Genetic progress in homogeneous regions of wheat cultivation in Rio Grande do Sul State, Brazil.

PubMed

Follmann, D N; Cargnelutti Filho, A; Lúcio, A D; de Souza, V Q; Caraffa, M; Wartha, C A

2017-03-30

The State of Rio Grande do Sul (RS) stands out as the largest wheat producer in Brazil. Wheat is the most emphasized winter cereal in RS, attracting public and private investments directed to wheat genetic breeding. The study of genetic progress should be performed routinely at breeding programs to study the behavior of cultivars developed for homogeneous regions of cultivation. The objectives of this study were: 1) to evaluate the genetic progress of wheat grain yield in RS; 2) to evaluate the influence of cultivar competition trial stratification in homogeneous regions of cultivation on the study of genetic progress. Grain yield data of 122 wheat cultivars evaluated in 137 trials arranged in randomized block design with three or four replications were used. Field trials were carried out in 23 locations in RS divided into two homogeneous regions during the period from 2002 to 2013. Genetic progress for RS and homogeneous regions was studied utilizing the method proposed by Vencovsky. Annual genetic progress for wheat grain yield during the period of 12 years in the State of RS was 2.86%, oscillating between homogeneous regions of cultivation. The difference of annual genetic progress in region 1 (1.82%) in relation to region 2 (4.38%) justifies the study of genetic progress by homogeneous regions of cultivation.

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

The Depression Inventory Development Workgroup: A Collaborative, Empirically Driven Initiative to Develop a New Assessment Tool for Major Depressive Disorder.

PubMed

Vaccarino, Anthony L; Evans, Kenneth R; Kalali, Amir H; Kennedy, Sidney H; Engelhardt, Nina; Frey, Benicio N; Greist, John H; Kobak, Kenneth A; Lam, Raymond W; MacQueen, Glenda; Milev, Roumen; Placenza, Franca M; Ravindran, Arun V; Sheehan, David V; Sills, Terrence; Williams, Janet B W

2016-01-01

The Depression Inventory Development project is an initiative of the International Society for CNS Drug Development whose goal is to develop a comprehensive and psychometrically sound measurement tool to be utilized as a primary endpoint in clinical trials for major depressive disorder. Using an iterative process between field testing and psychometric analysis and drawing upon expertise of international researchers in depression, the Depression Inventory Development team has established an empirically driven and collaborative protocol for the creation of items to assess symptoms in major depressive disorder. Depression-relevant symptom clusters were identified based on expert clinical and patient input. In addition, as an aid for symptom identification and item construction, the psychometric properties of existing clinical scales (assessing depression and related indications) were evaluated using blinded datasets from pharmaceutical antidepressant drug trials. A series of field tests in patients with major depressive disorder provided the team with data to inform the iterative process of scale development. We report here an overview of the Depression Inventory Development initiative, including results of the third iteration of items assessing symptoms related to anhedonia, cognition, fatigue, general malaise, motivation, anxiety, negative thinking, pain and appetite. The strategies adopted from the Depression Inventory Development program, as an empirically driven and collaborative process for scale development, have provided the foundation to develop and validate measurement tools in other therapeutic areas as well.

Systems biology approaches for identifying adverse drug reactions and elucidating their underlying biological mechanisms.

PubMed

Boland, Mary Regina; Jacunski, Alexandra; Lorberbaum, Tal; Romano, Joseph D; Moskovitch, Robert; Tatonetti, Nicholas P

2016-01-01

Small molecules are indispensable to modern medical therapy. However, their use may lead to unintended, negative medical outcomes commonly referred to as adverse drug reactions (ADRs). These effects vary widely in mechanism, severity, and populations affected, making ADR prediction and identification important public health concerns. Current methods rely on clinical trials and postmarket surveillance programs to find novel ADRs; however, clinical trials are limited by small sample size, whereas postmarket surveillance methods may be biased and inherently leave patients at risk until sufficient clinical evidence has been gathered. Systems pharmacology, an emerging interdisciplinary field combining network and chemical biology, provides important tools to uncover and understand ADRs and may mitigate the drawbacks of traditional methods. In particular, network analysis allows researchers to integrate heterogeneous data sources and quantify the interactions between biological and chemical entities. Recent work in this area has combined chemical, biological, and large-scale observational health data to predict ADRs in both individual patients and global populations. In this review, we explore the rapid expansion of systems pharmacology in the study of ADRs. We enumerate the existing methods and strategies and illustrate progress in the field with a model framework that incorporates crucial data elements, such as diet and comorbidities, known to modulate ADR risk. Using this framework, we highlight avenues of research that may currently be underexplored, representing opportunities for future work. © 2015 Wiley Periodicals, Inc.

Immobilization of swift foxes with ketamine hydrochloride-xylazine hydrochloride

USGS Publications Warehouse

Telesco, R.L.; Sovada, Marsha A.

2002-01-01

There is an increasing need to develop field immobilization techniques that allow researchers to handle safely swift foxes (Vulpes velox) with minimal risk of stress or injury. We immobilized captive swift foxes to determine the safety and effectiveness of ketamine hydrochloride and xylazine hydrochloride at different dosages. We attempted to determine appropriate dosages to immobilize swift foxes for an adequate field-handling period based on three anesthesia intervals (induction period, immobilization period, and recovery period) and physiologic responses (rectal temperature, respiration rate, and heart rate). Between October 1998–July 1999, we conducted four trials, evaluating three different dosage ratios of ketamine and xylazine (2.27:1.2, 5.68:1.2, and 11.4:1.2 mg/kg ketamine:mg/kg xylazine, respectively), followed by a fourth trial with a higher dosage at the median ratio (11.4 mg/kg ketamine:2.4 mg/kg xylazine). We found little difference in induction and recovery periods among trials 1–3, but immobilization time increased with increasing dosage (P<0.08). Both the immobilization period and recovery period increased in trial 4 compared with trials 1–3 (P≤0.03). There was a high variation in responses of individual foxes across trials, making it difficult to identify an appropriate dosage for field handling. Heart rate and respiration rates were depressed but all physiologic measures remained within normal parameters established for domestic canids. We recommend a dosage ratio of 10 mg/kg ketamine to 1 mg/kg xylazine to immobilize swift foxes for field handling.

A baiting system for delivery of an oral plague vaccine to black-tailed prairie dogs

USGS Publications Warehouse

Creekmore, Terry E.; Rocke, Tonie E.; Hurley, J.

2002-01-01

Laboratory and field studies were conducted between July and October 1999 to identify bait preference, biomarker efficacy, and bait acceptance rates for delivering an oral plague vaccine to black-tailed prairie dogs (Cynomys ludovicianus). Twenty juvenile captive prairie dogs were offered alfalfa baits containing either alfalfa, alfalfa and 5% molasses, or alfalfa, 5% molasses and 4% salt. Based on the results of these trials we selected a bait containing alfalfa, 7% molasses, and 1% salt for field trials to determine bait acceptance rates by free-ranging animals. The biomarkers DuPont Blue dye, iophenoxic acid, and tetracycline hydrochloride were orally administered to captive prairie dogs to determine their efficacy. Only tetracycline proved effective as a biomarker. Two field trials were conducted at separate prairie dog colonies located at the Buffalo Gap National Grassland (Pennington County, South Dakota, USA). In Trial 1, three baits containing tetracycline were distributed around each active burrow entrance and an additional bait was placed inside the burrow (1,276 baits total). In Trial 2, baits were distributed at the same density per burrow as Trial 1, but along transects spaced 10 m apart (1,744 baits total). Trapping began 3 days after bait distribution, and 30 prairie dogs then were captured at each site to determine the percentage of animals marked. In Trial 1, 67% of the prairie dogs captured had tetracycline deposits indicative of bait consumption. In Trial 2, 83% of the prairie dogs had ingested a bait. Approximately 15% of the animals in both trials ate more than one bait. Fleas (Opisocrostis hirsutus) were found on 64 of 70 (91%) of the prairie dogs captured during this study.

DSM-5 field trials in the United States and Canada, Part I: study design, sampling strategy, implementation, and analytic approaches.

PubMed

Clarke, Diana E; Narrow, William E; Regier, Darrel A; Kuramoto, S Janet; Kupfer, David J; Kuhl, Emily A; Greiner, Lisa; Kraemer, Helena C

2013-01-01

This article discusses the design,sampling strategy, implementation,and data analytic processes of the DSM-5 Field Trials. The DSM-5 Field Trials were conducted by using a test-retest reliability design with a stratified sampling approach across six adult and four pediatric sites in the United States and one adult site in Canada. A stratified random sampling approach was used to enhance precision in the estimation of the reliability coefficients. A web-based research electronic data capture system was used for simultaneous data collection from patients and clinicians across sites and for centralized data management.Weighted descriptive analyses, intraclass kappa and intraclass correlation coefficients for stratified samples, and receiver operating curves were computed. The DSM-5 Field Trials capitalized on advances since DSM-III and DSM-IV in statistical measures of reliability (i.e., intraclass kappa for stratified samples) and other recently developed measures to determine confidence intervals around kappa estimates. Diagnostic interviews using DSM-5 criteria were conducted by 279 clinicians of varied disciplines who received training comparable to what would be available to any clinician after publication of DSM-5.Overall, 2,246 patients with various diagnoses and levels of comorbidity were enrolled,of which over 86% were seen for two diagnostic interviews. A range of reliability coefficients were observed for the categorical diagnoses and dimensional measures. Multisite field trials and training comparable to what would be available to any clinician after publication of DSM-5 provided “real-world” testing of DSM-5 proposed diagnoses.

The extended Infant Feeding, Activity and Nutrition Trial (InFANT Extend) Program: a cluster-randomized controlled trial of an early intervention to prevent childhood obesity.

PubMed

Campbell, Karen J; Hesketh, Kylie D; McNaughton, Sarah A; Ball, Kylie; McCallum, Zoë; Lynch, John; Crawford, David A

2016-02-18

Understanding how we can prevent childhood obesity in scalable and sustainable ways is imperative. Early RCT interventions focused on the first two years of life have shown promise however, differences in Body Mass Index between intervention and control groups diminish once the interventions cease. Innovative and cost-effective strategies seeking to continue to support parents to engender appropriate energy balance behaviours in young children need to be explored. The Infant Feeding Activity and Nutrition Trial (InFANT) Extend Program builds on the early outcomes of the Melbourne InFANT Program. This cluster randomized controlled trial will test the efficacy of an extended (33 versus 15 month) and enhanced (use of web-based materials, and Facebook® engagement), version of the original Melbourne InFANT Program intervention in a new cohort. Outcomes at 36 months of age will be compared against the control group. This trial will provide important information regarding capacity and opportunities to maximize early childhood intervention effectiveness over the first three years of life. This study continues to build the evidence base regarding the design of cost-effective, scalable interventions to promote protective energy balance behaviors in early childhood, and in turn, promote improved child weight and health across the life course. ACTRN12611000386932. Registered 13 April 2011.

Study protocol: a pragmatic randomised controlled trial of a 12-week physical activity and nutritional education program for overweight Aboriginal and Torres Strait Islander women.

PubMed

Canuto, Karla J; McDermott, Robyn A; Cargo, Margaret; Esterman, Adrian J

2011-08-19

Aboriginal and Torres Strait Islander women have a higher prevalence and incidence of obesity and type 2 diabetes than non-Indigenous Australian women. Physical inactivity is a key modifiable risk factor for obesity and evidence shows that even modest reductions in waist circumference (WC) have significant health benefits. Trialing physical activity programs in difficult-to-reach high risk groups, especially urban Indigenous Australians poses distinct implementation challenges. The trial objective is to evaluate the effectiveness of a structured 12-week physical activity group program with nutritional advice. The design is a pragmatic randomised controlled trial. This study protocol describes the implementation and evaluation of the program. Participants are randomised into either an intervention or waitlisted group. The waitlisted group have a 12 month waiting period before commencing the 12-week program. Participant data is collected at baseline, 12, 24 and 52 weeks. Participants are Aboriginal and Torres Strait Islander women, aged 18-64 years with a waist circumference greater than 80 centimetres residing in Adelaide. The primary outcome measure is WC change immediately post program from baseline. Secondary outcomes include short term and long term changes in WC, weight, blood pressure, fasting blood glucose, insulin, insulin resistance (calculated HOMA), haemoglobin A1C (HbA1C), triglycerides and C-reactive protein (CRP). Behavioural and psychosocial surveys are administered to assess physical activity, dietary intake and the participant's motivation, self-efficacy and perceived social support for physical activity. Qualitative interviews focusing on participants' motivation, enablers and barriers to healthy eating and physical activity will be undertaken. Implementation fidelity and participation are also assessed. The Aboriginal and Torres Strait Islander Women's Fitness Program (WFP) is designed to provide a rigorous physiological and client-based evaluation of a structured 12-week program aimed to increase metabolic fitness and reduce WC in this high risk population. Evaluation results aim to provide the support necessary to design programs that are accessible, affordable and effective at reducing WC, while also improving the metabolic profile of overweight Aboriginal and Torres Strait Islander women. Australian New Zealand Clinical Trials Registry ACTRN12610000224022.

Occupational rehabilitation programs for musculoskeletal pain and common mental health disorders: study protocol of a randomized controlled trial

PubMed Central

2014-01-01

Background Long-term sick leave has considerably negative impact on the individual and society. Hence, the need to identify effective occupational rehabilitation programs is pressing. In Norway, group based occupational rehabilitation programs merging patients with different diagnoses have existed for many years, but no rigorous evaluation has been performed. The described randomized controlled trial aims primarily to compare two structured multicomponent inpatient rehabilitation programs, differing in length and content, with a comparative cognitive intervention. Secondarily the two inpatient programs will be compared with each other, and with a usual care reference group. Methods/design The study is designed as a randomized controlled trial with parallel groups. The Social Security Office performs monthly extractions of sick listed individuals aged 18–60 years, on sick leave 2–12 months, with sick leave status 50% - 100% due to musculoskeletal, mental or unspecific disorders. Sick-listed persons are randomized twice: 1) to receive one of two invitations to participate in the study or not receive an invitation, where the latter “untouched” control group will be monitored for future sick leave in the National Social Security Register, and 2) after inclusion, to a Long or Short inpatient multicomponent rehabilitation program (depending on which invitation was sent) or an outpatient cognitive behavioral therapy group comparative program. The Long program consists of 3 ½ weeks with full rehabilitation days. The Short program consists of 4 + 4 full days, separated by two weeks, in which a workplace visit will be performed if desirable. Three areas of rehabilitation are targeted: mental training, physical training and work-related problem solving. The primary outcome is number of sick leave days. Secondary outcomes include time until full sustainable return to work, health related quality of life, health related behavior, functional status, somatic and mental health, and perceptions of work. In addition, health economic evaluation will be performed, and the implementation of the interventions, expectations and experiences of users and service providers will be investigated with different qualitative methods. Trial registration ClinicalTrials.gov: NCT01926574. PMID:24735616

UV Waterworks Outreach Support. Final Report

DOE R&D Accomplishments Database

Miller, P.

1998-05-01

A recently invented device uses UV light (254 nm) to inexpensively disinfect community drinking water supplies. Its novel features are: low cost (about US $600), robust design, rapid disinfection (12 seconds), low electricity use (40W), low maintenance (every 6 months), high flow rate (15 l/min) and ability to work with unpressurized water sources. The device could service a community of 1,000 persons, at an annual total cost of 14 cents US per person. This device has been tested in a number of independent laboratories worldwide. The laboratory tests have confirmed that the unit is capable of disinfecting waters to drinking water standards for bacteria and viruses. An extended field trial of the device began in South Africa in February 1997, with lab testing at the municipal water utility. A unit installed at the first field site, an AIDS hospice near Durban, has been in continuous operation since August, 1997. Additional test sites are being identified. The author describes the results of the initial lab tests, reports the most recent findings from the ongoing field test-monitoring program, and discusses plans for future tests.

How can we improve clinical research in pneumonia?

PubMed

Ramirez, Julio A

2018-05-01

The primary challenges in the field of clinical research include a lack of support within existing infrastructure, insufficient number of clinical research training programs and a paucity of qualified mentors. Most medical centers offer infrastructure support for investigators working with industry sponsors or government-funded clinical trials, yet there are a significant amount of clinical studies performed in the field of pneumonia which are observational studies. For this type of research, which is frequently unfunded, support is usually lacking. In an attempt to optimize clinical research in pneumonia, at the University of Louisville, we developed a clinical research coordinating center (CRCC). The center manages clinical studies in the field of respiratory infections, with the primary focus being pneumonia. Other activities of the CRCC include the organization of an annual clinical research training course for physicians and other healthcare workers, and the facilitation of international research mentoring by a process of connecting new pneumonia investigators with established clinical investigators. To improve clinical research in pneumonia, institutions need to have the appropriate infrastructure in place to support investigators in all aspects of the clinical research process.

Behavioral and locomotor measurements using an open field activity monitoring system for skeletal muscle diseases.

PubMed

Tatem, Kathleen S; Quinn, James L; Phadke, Aditi; Yu, Qing; Gordish-Dressman, Heather; Nagaraju, Kanneboyina

2014-09-29

The open field activity monitoring system comprehensively assesses locomotor and behavioral activity levels of mice. It is a useful tool for assessing locomotive impairment in animal models of neuromuscular disease and efficacy of therapeutic drugs that may improve locomotion and/or muscle function. The open field activity measurement provides a different measure than muscle strength, which is commonly assessed by grip strength measurements. It can also show how drugs may affect other body systems as well when used with additional outcome measures. In addition, measures such as total distance traveled mirror the 6 min walk test, a clinical trial outcome measure. However, open field activity monitoring is also associated with significant challenges: Open field activity measurements vary according to animal strain, age, sex, and circadian rhythm. In addition, room temperature, humidity, lighting, noise, and even odor can affect assessment outcomes. Overall, this manuscript provides a well-tested and standardized open field activity SOP for preclinical trials in animal models of neuromuscular diseases. We provide a discussion of important considerations, typical results, data analysis, and detail the strengths and weaknesses of open field testing. In addition, we provide recommendations for optimal study design when using open field activity in a preclinical trial.

Reforming the community research program: from Community Clinical Oncology Program to the National Cancer Institute Community Oncology Research Program.

PubMed

Zon, Robin T

2014-01-01

Community research has been an integral and influential component of the National Research Program since the late 1970s. Institutionalization of community research in the Community Clinical Oncology Program (CCOP) has resulted in successful collaborations, meaningful accrual, achievement of quality standards, and translation of research into clinical practice. Although the national clinical trial system is undergoing modernization and improvement, the success of the CCOP and minority-based CCOP in cancer treatment, prevention, and control research is being extended to include cancer care delivery research in the newly created National Cancer Institute (NCI) Community Oncology Research Program. This article briefly presents a historic perspective of community involvement in federally sponsored clinical trials and introduces the continued involvement in the newly created NCI program.

Antiretroviral drug regimens to prevent mother-to-child transmission of HIV: a review of scientific, program, and policy advances for sub-Saharan Africa.

PubMed

Chi, Benjamin H; Stringer, Jeffrey S A; Moodley, Dhayendre

2013-06-01

Considerable advances have been made in the effort to prevent mother-to-child HIV transmission (PMTCT) in sub-Saharan Africa. Clinical trials have demonstrated the efficacy of antiretroviral regimens to interrupt HIV transmission through the antenatal, intrapartum, and postnatal periods. Scientific discoveries have been rapidly translated into health policy, bolstered by substantial investment in health infrastructure capable of delivering increasingly complex services. A new scientific agenda is also emerging, one that is focused on the challenges of effective and sustainable program implementation. Finally, global campaigns to "virtually eliminate" pediatric HIV and dramatically reduce HIV-related maternal mortality have mobilized new resources and renewed political will. Each of these developments marks a major step in regional PMTCT efforts; their convergence signals a time of rapid progress in the field, characterized by an increased interdependency between clinical research, program implementation, and policy. In this review, we take stock of recent advances across each of these areas, highlighting the challenges--and opportunities--of improving health services for HIV-infected mothers and their children across the region.

Implications of measures of quality of life for policy development.

PubMed

Mosteller, F

1987-01-01

Quality of life measurements can lead to legislative programs for health, new policies for the health care system, and possibly new attitudes in the courts. Clinical decisions, public health evaluations, and advice for legislatures and courts require diverse measures. We illustrate potential use of such measures with reimbursement problems, programs like Head Start, mainstreaming the handicapped, day care and prenatal care, terminal care for the elderly, monitoring programs, and chronic disabilities. The many treatment policies discussed at the Portugal Conference show the need for quality of life measures in clinical trials. The courts, although considering quality of life, do not seem to consider quality of life measures. If scientists and medical experts wish to establish or change the positions of the courts, consensus conferences appear more effective than regulation or new legislation. To contribute more than they now do to policy, workers measuring quality of life need to develop a variety of measures and methods. They, then, must apply them to medical and health problems, build up a substantial literature, and set priorities for the research needs of the field.

Health and Safety Research Division: Progress report, October 1, 1985-March 31, 1987

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

Walsh, P.J.

1987-09-01

This report summarizes the progress in our programs for the period October 1, 1985, through March 31, 1987. The division's presentations and publications represented important contributions on the forefronts of many fields. Eleven invention disclosures were filed, two patent applications submitted, and one patent issued. The company's transfers new technologies to the private sector more efficiently than in the past. The division's responsibilities to DOE under the Uranium Mill Tailings Remedial Action (UMTRA) program includes inclusion recommendations for 3100 properties. The nuclear medicine program developed new radiopharmaceuticals and radionuclide generators through clinical trials with some of our medical cooperatives. Twomore » major collaborative indoor air quality studies and a large epidemiological study of drinking water quality and human health were completed. ORNL's first scanning tunneling microscope (STM) has achieved single atom resolution and has produced some of the world's best images of single atoms on the surface of a silicon crystal. The Biological and Radiation Physics Section, designed and constructed a soft x-ray spectrometer which has exhibited a measuring efficiency that is 10,000 times higher than other equipment. 1164 refs.« less

Interventions Using Regular Activities to Engage High-Risk School-Age Youth: a Review of After-School Programs in Latin America and the Caribbean.

PubMed

Cid, Alejandro

2017-10-01

In this paper, I review an issue that is an urgent challenge in the development field-the effectiveness of after-school programs for preventing school-age youth violence in vulnerable settings in Latin American and the Caribbean. These programs have proliferated in the region and include sports, recreation, music, tutoring, and other focused activities. Given their popularity and because they target known risk factors for violence (such as drop-out from school, poor academic performance, lack of motivation, too much idle time, low quality and quantity of adult supervision, and social isolation), it is critical to examine empirically whether they can be effective prevention strategies. Unfortunately, most rigorous trials of after-school interventions to prevent youth violence have been conducted in developed countries, with far fewer in Latin America. In this review, a broad range of databases was searched systematically. Only six studies in five Latin American and Caribbean countries were identified. Reported results indicate at least some benefits for youth behavior, although not across all youth. Additional concerns regarding how these programs are implemented and whether specific components can be tied to violence prevention are noted. The need for more rigorous evaluation of these programs is noted.

Assessment Data-Informed Guidance to Individualize Kindergarten Reading Instruction: Findings from a Cluster-Randomized Control Field Trial

ERIC Educational Resources Information Center

Al Otaiba, Stephanie; Connor, Carol M.; Folsom, Jessica S.; Greulich, Luana; Meadows, Jane; Li, Zhi

2011-01-01

The purpose of this cluster-randomized control field trial was to examine whether kindergarten teachers could learn to differentiate classroom reading instruction using Individualized Student Instruction for Kindergarten (ISI-K) and to test the efficacy of differentiation on reading outcomes. The study involved 14 schools, 23 ISI-K (n = 305…

Formulations of the endophytic bacterium Bacillus subtilis Tu-100 suppress Sclerotinia sclerotiorum on oilseed rape and improve plant vigor in field trials conducted at separate locations

USDA-ARS?s Scientific Manuscript database

Sclerotinia sclerotiorum causes serious yield losses in crops in The People’s Republic of China. Two formulations of oilseed rape seed containing the endophytic bacterium Bacillus subtilis Tu-100 were evaluated for suppression of this pathogen in field trials conducted at two independent locations....

SUPERFUND TREATABILITY CLEARINGHOUSE: FULL ...

EPA Pesticide Factsheets

This treatability study reports on the results of one of a series of field trials using various remedial action technologies that may be capable of restoring Herbicide Orange (HO)XDioxin contaminated sites. A full-scale field trial using a rotary kiln incinerator capable of processing up to 6 tons per hour of dioxin contaminated soil was conducted at the Naval Construction Battalion Center, Gulfport, MS. publish information

Field-testing UV disinfection of drinking water

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

Gadgil, A.; Drescher, A.; Greene, D.

A recently invented device, ``UV Waterworks,`` uses ultraviolet (UV) light to disinfect drinking water. Its novel features are: low cost, robust design, rapid disinfection, low electricity use, low maintenance, high flow rate and ability to work with unpressurized water sources. The device could service a community of 1,000 persons, at an annual total cost of less than 10 US cents per person. UV Waterworks has been successfully tested in the laboratory. Limited field trials of an early version of the device were conducted in India in 1994--95. Insights from these trials led to the present design. Extended field trials ofmore » UV Waterworks, initiated in South Africa in February 1997, will be coordinated by the South African Center for Essential Community Services (SACECS), with technical and organizational support from Lawrence Berkeley National Laboratory(LBNL) and the Natural Resources Defense Council (both US). The first of the eight planned sites of the year long trial is an AIDS hospice near Durban. Durban metro Water and LBNL lab-tested a UV Waterworks unit prior to installing it at the hospice in August, 1997. The authors describe the field test plans and preliminary results from Durban.« less

Impact of an indigenous microbial enhanced oil recovery field trial on microbial community structure in a high pour-point oil reservoir.

PubMed

Zhang, Fan; She, Yue-Hui; Li, Hua-Min; Zhang, Xiao-Tao; Shu, Fu-Chang; Wang, Zheng-Liang; Yu, Long-Jiang; Hou, Du-Jie

2012-08-01

Based on preliminary investigation of microbial populations in a high pour-point oil reservoir, an indigenous microbial enhanced oil recovery (MEOR) field trial was carried out. The purpose of the study is to reveal the impact of the indigenous MEOR process on microbial community structure in the oil reservoir using 16Sr DNA clone library technique. The detailed monitoring results showed significant response of microbial communities during the field trial and large discrepancies of stimulated microorganisms in the laboratory and in the natural oil reservoir. More specifically, after nutrients injection, the original dominant populations of Petrobacter and Alishewanella in the production wells almost disappeared. The expected desirable population of Pseudomonas aeruginosa, determined by enrichment experiments in laboratory, was stimulated successfully in two wells of the five monitored wells. Unexpectedly, another potential population of Pseudomonas pseudoalcaligenes which were not detected in the enrichment culture in laboratory was stimulated in the other three monitored production wells. In this study, monitoring of microbial community displayed a comprehensive alteration of microbial populations during the field trial to remedy the deficiency of culture-dependent monitoring methods. The results would help to develop and apply more MEOR processes.

The reliability of a VISION COACH task as a measure of psychomotor skills.

PubMed

Xi, Yubin; Rosopa, Patrick J; Mossey, Mary; Crisler, Matthew C; Drouin, Nathalie; Kopera, Kevin; Brooks, Johnell O

2014-10-01

The VISION COACH™ interactive light board is designed to test and enhance participants' psychomotor skills. The primary goal of this study was to examine the test-retest reliability of the Full Field 120 VISION COACH task. One hundred eleven male and 131 female adult participants completed six trials where they responded to 120 randomly distributed lights displayed on the VISION COACH interactive light board. The mean time required for a participant to complete a trial was 101 seconds. Intraclass correlation coefficients, ranging from 0.962 to 0.987 suggest the VISION COACH Full Field 120 task was a reliable task. Cohen's d's of adjacent pairs of trials suggest learning effects did not negatively affect reliability after the third trial.

Redesigning Radiotherapy Quality Assurance: Opportunities to Develop an Efficient, Evidence-Based System to Support Clinical Trials-Report of the National Cancer Institute Work Group on Radiotherapy Quality Assurance

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

Bekelman, Justin E., E-mail: bekelman@uphs.upenn.edu; Deye, James A.; Vikram, Bhadrasain

2012-07-01

Purpose: In the context of national calls for reorganizing cancer clinical trials, the National Cancer Institute sponsored a 2-day workshop to examine challenges and opportunities for optimizing radiotherapy quality assurance (QA) in clinical trial design. Methods and Materials: Participants reviewed the current processes of clinical trial QA and noted the QA challenges presented by advanced technologies. The lessons learned from the radiotherapy QA programs of recent trials were discussed in detail. Four potential opportunities for optimizing radiotherapy QA were explored, including the use of normal tissue toxicity and tumor control metrics, biomarkers of radiation toxicity, new radiotherapy modalities such asmore » proton beam therapy, and the international harmonization of clinical trial QA. Results: Four recommendations were made: (1) to develop a tiered (and more efficient) system for radiotherapy QA and tailor the intensity of QA to the clinical trial objectives (tiers include general credentialing, trial-specific credentialing, and individual case review); (2) to establish a case QA repository; (3) to develop an evidence base for clinical trial QA and introduce innovative prospective trial designs to evaluate radiotherapy QA in clinical trials; and (4) to explore the feasibility of consolidating clinical trial QA in the United States. Conclusion: Radiotherapy QA can affect clinical trial accrual, cost, outcomes, and generalizability. To achieve maximum benefit, QA programs must become more efficient and evidence-based.« less

Redesigning radiotherapy quality assurance: opportunities to develop an efficient, evidence-based system to support clinical trials--report of the National Cancer Institute Work Group on Radiotherapy Quality Assurance.

PubMed

Bekelman, Justin E; Deye, James A; Vikram, Bhadrasain; Bentzen, Soren M; Bruner, Deborah; Curran, Walter J; Dignam, James; Efstathiou, Jason A; FitzGerald, T J; Hurkmans, Coen; Ibbott, Geoffrey S; Lee, J Jack; Merchant, Thomas E; Michalski, Jeff; Palta, Jatinder R; Simon, Richard; Ten Haken, Randal K; Timmerman, Robert; Tunis, Sean; Coleman, C Norman; Purdy, James

2012-07-01

In the context of national calls for reorganizing cancer clinical trials, the National Cancer Institute sponsored a 2-day workshop to examine challenges and opportunities for optimizing radiotherapy quality assurance (QA) in clinical trial design. Participants reviewed the current processes of clinical trial QA and noted the QA challenges presented by advanced technologies. The lessons learned from the radiotherapy QA programs of recent trials were discussed in detail. Four potential opportunities for optimizing radiotherapy QA were explored, including the use of normal tissue toxicity and tumor control metrics, biomarkers of radiation toxicity, new radiotherapy modalities such as proton beam therapy, and the international harmonization of clinical trial QA. Four recommendations were made: (1) to develop a tiered (and more efficient) system for radiotherapy QA and tailor the intensity of QA to the clinical trial objectives (tiers include general credentialing, trial-specific credentialing, and individual case review); (2) to establish a case QA repository; (3) to develop an evidence base for clinical trial QA and introduce innovative prospective trial designs to evaluate radiotherapy QA in clinical trials; and (4) to explore the feasibility of consolidating clinical trial QA in the United States. Radiotherapy QA can affect clinical trial accrual, cost, outcomes, and generalizability. To achieve maximum benefit, QA programs must become more efficient and evidence-based. Copyright © 2012 Elsevier Inc. All rights reserved.

COMPUTERIZED EXPERT SYSTEM FOR EVALUATION OF AUTOMATED VISUAL FIELDS FROM THE ISCHEMIC OPTIC NEUROPATHY DECOMPRESSION TRIAL: METHODS, BASELINE FIELDS, AND SIX-MONTH LONGITUDINAL FOLLOW-UP

PubMed Central

Feldon, Steven E

2004-01-01

ABSTRACT Purpose To validate a computerized expert system evaluating visual fields in a prospective clinical trial, the Ischemic Optic Neuropathy Decompression Trial (IONDT). To identify the pattern and within-pattern severity of field defects for study eyes at baseline and 6-month follow-up. Design Humphrey visual field (HVF) change was used as the outcome measure for a prospective, randomized, multi-center trial to test the null hypothesis that optic nerve sheath decompression was ineffective in treating nonarteritic anterior ischemic optic neuropathy and to ascertain the natural history of the disease. Methods An expert panel established criteria for the type and severity of visual field defects. Using these criteria, a rule-based computerized expert system interpreted HVF from baseline and 6-month visits for patients randomized to surgery or careful follow-up and for patients who were not randomized. Results A computerized expert system was devised and validated. The system was then used to analyze HVFs. The pattern of defects found at baseline for patients randomized to surgery did not differ from that of patients randomized to careful follow-up. The most common pattern of defect was a superior and inferior arcuate with central scotoma for randomized eyes (19.2%) and a superior and inferior arcuate for nonrandomized eyes (30.6%). Field patterns at 6 months and baseline were not different. For randomized study eyes, the superior altitudinal defects improved (P = .03), as did the inferior altitudinal defects (P = .01). For nonrandomized study eyes, only the inferior altitudinal defects improved (P = .02). No treatment effect was noted. Conclusions A novel rule-based expert system successfully interpreted visual field defects at baseline of eyes enrolled in the IONDT. PMID:15747764

Commercial programs' online weight loss claims as compared to results from randomized controlled trials

PubMed Central

Vakil, Rachit M.; Chaudhry, Zoobia W.; Doshi, Ruchi S.; Clark, Jeanne M.; Gudzune, Kimberly A.

2017-01-01

Objective To characterize weight-loss claims and disclaimers present on websites for commercial weight-loss programs and compare them to results from published randomized controlled trials (RCT). Methods We performed a content analysis of all homepages and testimonials available on the websites of 24 randomly selected programs. Two team members independently reviewed each page and abstracted information from text and images to capture relevant content including demographics, weight loss, and disclaimers. We performed a systematic review to evaluate the efficacy of these programs by searching MEDLINE and Cochrane Database of Systematic Reviews, and abstracted mean weight change from each included RCT. Results Overall, the amount of weight loss portrayed in the testimonials was extreme across all programs examined (range median weight loss 10.7 to 49.5 kg). Only 10 out of the 24 programs had eligible RCTs. Median weight losses reported in testimonials exceeded that achieved by trial participants. Most programs with RCTs (78%) provided disclaimers stating that the testimonial's results were non-typical and/or giving a range of typical weight loss. Conclusion Weight loss claims within testimonials were higher than results from RCTs. Future studies should examine whether commercial programs' advertising practices influence patients' expectations or satisfaction with modest weight loss results. PMID:28865085

Social Information-Processing Skills and Aggression: A Quasi-Experimental Trial of the Making Choices and Making Choices Plus Programs

ERIC Educational Resources Information Center

Terzian, Mary A.; Li, Jilan; Fraser, Mark W.; Day, Steven H.; Rose, Roderick A.

2015-01-01

This article describes the findings from an efficacy trial of a school-based, universal prevention program designed to reduce aggressive behavior of by strengthening emotion regulation and social information-processing (SIP) skills. Three cohorts of third graders (N = 479) participated in this study. The first cohort participated in the Making…

Webcam Delivery of the Lidcombe Program for Early Stuttering: A Phase I Clinical Trial

ERIC Educational Resources Information Center

O'Brian, Sue; Smith, Kylie; Onslow, Mark

2014-01-01

Purpose: The Lidcombe Program is an operant treatment for early stuttering shown with meta-analysis to have a favorable odds ratio. However, many clients are unable to access the treatment because of distance and lifestyle factors. In this Phase I trial, we explored the potential efficacy, practicality, and viability of an Internet webcam Lidcombe…

The YouthMood Project: A Cluster Randomized Controlled Trial of an Online Cognitive Behavioral Program with Adolescents

ERIC Educational Resources Information Center

Calear, Alison L.; Christensen, Helen; Mackinnon, Andrew; Griffiths, Kathleen M.; O'Kearney, Richard

2009-01-01

The aim in the current study was to investigate the effectiveness of an online, self-directed cognitive-behavioral therapy program (MoodGYM) in preventing and reducing the symptoms of anxiety and depression in an adolescent school-based population. A cluster randomized controlled trial was conducted with 30 schools (N = 1,477) from across…

Project SUCCESS' Effects on Substance Use-Related Attitudes and Behaviors: A Randomized Controlled Trial in Alternative High Schools

ERIC Educational Resources Information Center

Clark, Heddy Kovach; Ringwalt, Chris L.; Shamblen, Stephen R.; Hanley, Sean M.

2011-01-01

Using a randomized controlled effectiveness trial, we examined the effects of Project SUCCESS on a range of secondary outcomes, including the program's mediating variables. Project SUCCESS, which is based both on the Theory of Reasoned Action and on Cognitive Behavior Theory, is a school-based substance use prevention program that targets…

A Multicenter, Randomized Clinical Trial of a Cognitive Remediation Program for Childhood Survivors of a Pediatric Malignancy

ERIC Educational Resources Information Center

Butler, Robert W.; Copeland, Donna R.; Fairclough, Diane L.; Mulhern, Raymond K.; Katz, Ernest R.; Kazak, Anne E.; Noll, Robert B.; Patel, Sunita K.; Sahler, Olle Jane Z.

2008-01-01

Survivors of childhood cancer whose malignancy and/or treatment involved the central nervous system may demonstrate a consistent pattern of neurocognitive deficits. The present study evaluated a randomized clinical trial of the Cognitive Remediation Program (CRP). Participants were 6- to 17-year-old survivors of childhood cancer (N = 161; 35%…

A Randomized Controlled Trial for Children with Childhood Apraxia of Speech Comparing Rapid Syllable Transition Treatment and the Nuffield Dyspraxia Programme-Third Edition

ERIC Educational Resources Information Center

Murray, Elizabeth; McCabe, Patricia; Ballard, Kirrie J.

2015-01-01

Purpose: This randomized controlled trial compared the experimental Rapid Syllable Transition (ReST) treatment to the Nuffield Dyspraxia Programme-Third Edition (NDP3; Williams & Stephens, 2004), used widely in clinical practice in Australia and the United Kingdom. Both programs aim to improve speech motor planning/programming for children…

An Innovative Multiphased Strategy to Recruit Underserved Adults into a Randomized Trial of a Community-Based Diabetes Risk Reduction Program

ERIC Educational Resources Information Center

Santoyo-Olsson, Jasmine; Cabrera, Julissa; Freyre, Rachel; Grossman, Melanie; Alvarez, Natalie; Mathur, Deepika; Guerrero, Maria; Delgadillo, Adriana T.; Kanaya, Alka M.; Stewart, Anita L.

2011-01-01

Purpose: To conduct and evaluate a two-phased community-based approach to recruit lower socioeconomic status, minority, or Spanish-speaking adults at risk of developing diabetes to a randomized trial of a lifestyle intervention program delivered by a public health department. Design: Within geographic areas comprising our target population, 4…

Pilot Trial of a Disclosure Intervention for HIV+ Mothers: The TRACK Program

ERIC Educational Resources Information Center

Murphy, Debra A.; Armistead, Lisa; Marelich, William D.; Payne, Diana L.; Herbeck, Diane M.

2011-01-01

Objective: The "T"eaching, "R"aising, "A"nd "C"ommunicating with "K"ids (TRACK) program was a longitudinal pilot-trial intervention designed to assist mothers living with HIV (MLHs) to disclose their serostatus to their young children (age 6-12 years). Method: MLH and child dyads (N = 80 dyads) were recruited and randomized to intervention or…

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

ERIC Educational Resources Information Center

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

2015-01-01

Research suggests that impaired social skills are often the most significant challenge for those with autism spectrum disorder (ASD), yet few evidence-based social skills interventions exist for adults on the spectrum. This replication trial tested the effectiveness of PEERS, a caregiver-assisted social skills program for high-functioning young…

A Clustered Randomized Controlled Trial to Determine Impacts of the Harvest of the Month Program

ERIC Educational Resources Information Center

LaChausse, Robert G.

2017-01-01

The study purpose was to examine the impact of the Harvest of the Month (HOTM) program on fruit and vegetable (FV) consumption, FV preferences, other eating behaviors, physical activity and other variables related to healthy eating. A clustered randomized controlled trial was employed in 28 elementary schools. After parental consent was obtained,…

Impact of a Social-Emotional and Character Development Program on School-Level Indicators of Academic Achievement, Absenteeism, and Disciplinary Outcomes: A Matched-Pair, Cluster-Randomized, Controlled Trial

ERIC Educational Resources Information Center

Snyder, Frank; Flay, Brian; Vuchinich, Samuel; Acock, Alan; Washburn, Isaac; Beets, Michael; Li, Kin-Kit

2010-01-01

This article reports the effects of a comprehensive elementary school-based social-emotional and character education program on school-level achievement, absenteeism, and disciplinary outcomes utilizing a matched-pair, cluster-randomized, controlled design. The "Positive Action" Hawai'i trial included 20 racially/ethnically diverse…

A Quasi-Randomized Trial of a School-Wide Universal Prevention Program: Results and Lessons Learned

ERIC Educational Resources Information Center

Bodin, Maria C.; South, Sandra H.; Ingemarson, Maria

2016-01-01

Prevention in School (PS) is a comprehensive program which aims to improve the learning climate and reduce problem behavior in elementary schools. Core components are teaching of school rules, praise and rewards to support prosocial behavior, and a forum involving parents. This trial investigated the effects of PS on its intended outcomes, and…

Mechanism of Developmental Change in the PLAY Project Home Consultation Program: Evidence from a Randomized Control Trial

ERIC Educational Resources Information Center

Mahoney, Gerald; Solomon, Richard

2016-01-01

This investigation is a secondary analysis of data from a randomized control trial of the PLAY Home Consultation Intervention Program which was conducted with 112 preschool children with Autism Spectrum Disorders and their parents (Solomon et al. in "J Dev Behav Pediatr" 35:475-485, 2014). Subjects were randomly assigned to either a…

Effects of a single inhalative exposure to formaldehyde on the open field behavior of mice.

PubMed

Malek, Fathi A; Möritz, Klaus-Uwe; Fanghänel, Jochen

2004-02-01

The effects of formaldehyde on the explorative behavior and locomotor activity of mice after a single inhalative exposure were examined in an open field. Adult male mice were exposed to approximately 1.1 ppm, 2.3 ppm, or 5.2 ppm formaldehyde vapour for 2 hours and the open field test was carried out two hours after the end of exposure (trial 1) and repeated 24 hours thereafter (trial 2). The following behavioral parameters were quantitatively examined: numbers of crossed floor squares (inner, peripheral, total), sniffing, grooming, rearing, climbing, and incidence of fecal boli. The results of the first trial revealed that the motion activity was significantly reduced in all exposed groups. In the 1.1 ppm group, the frequency of rearing was reduced and that of floor sniffing increased. The exposure to the two higher formaldehyde concentrations caused a significant decrease in total numbers of floor squares crossed by the subjects, air sniffing, and rearing. The open field test on the next day (trial 2) showed that the frequencies of floor sniffing, grooming, and rearing in all formaldehyde groups were significantly altered. In the 2.5 ppm group, an increased incidence of fecal boli was observed. From the results obtained, we conclude that the exposure of male mice to formaldehyde vapour affects their locomotor and explorative activity in the open field, and that some open field parameters are still altered in the exposed animals even after 24 hours.

Validation of the DIFFAL, HPAC and HotSpot Dispersion Models Using the Full-Scale Radiological Dispersal Device (FSRDD) Field Trials Witness Plate Deposition Dataset.

PubMed

Purves, Murray; Parkes, David

2016-05-01

Three atmospheric dispersion models--DIFFAL, HPAC, and HotSpot--of differing complexities have been validated against the witness plate deposition dataset taken during the Full-Scale Radiological Dispersal Device (FSRDD) Field Trials. The small-scale nature of these trials in comparison to many other historical radiological dispersion trials provides a unique opportunity to evaluate the near-field performance of the models considered. This paper performs validation of these models using two graphical methods of comparison: deposition contour plots and hotline profile graphs. All of the models tested are assessed to perform well, especially considering that previous model developments and validations have been focused on larger-scale scenarios. Of the models, HPAC generally produced the most accurate results, especially at locations within ∼100 m of GZ. Features present within the observed data, such as hot spots, were not well modeled by any of the codes considered. Additionally, it was found that an increase in the complexity of the meteorological data input to the models did not necessarily lead to an improvement in model accuracy; this is potentially due to the small-scale nature of the trials.

Ongoing clinical trials of PD-1 and PD-L1 inhibitors for lung cancer in China.

PubMed

Liu, Si-Yang; Wu, Yi-Long

2017-07-05

Compared to chemotherapy, promising results have been obtained by blocking the PD-1 pathway using antibodies that inhibit programmed cell death protein 1 (PD-1) or programmed cell death protein ligand 1 (PD-L1). Furthermore, global researchers and doctors are exploring how to optimize this immunotherapy in 270 clinical studies. However, Chinese clinical trials of these agents remain in the early stages. We summarize the ongoing international and domestic clinical trials using PD-1 and PD-L1 inhibitors to treat lung cancer. This information can help researchers better understand the active and approved clinical trials in China, as well as the ongoing research regarding PD-1 and PD-L1 inhibitors.

Impact of navigation on knowledge and attitudes about clinical trials among Chinese patients undergoing treatment for breast and gynecologic cancers.

PubMed

Clair McClung, E; Davis, Sharon Watkins; Jeffrey, Stefanie S; Kuo, Mei-Chin; Lee, Marion M; Teng, Nelson N H

2015-06-01

Racial, ethnic and economic disparities in cancer rates, outcomes, and clinical trials participation persist despite significant research. We examined barriers to clinical trials enrollment among Chinese patients, and developed a navigation program for Chinese gynecologic and breast cancer patients. Six bilingual navigators were trained and a navigator assigned to each patient for at least 2 months. All patients received a clinical trials booklet in Chinese and English. Data collection included pre-and post-navigation surveys, intake forms, and documentation of navigation encounters. Between July 2010 and May 31, 2011, we recruited 28 breast and gynecologic cancer patients. Patients averaged 317 min of navigation (range 63-1,852) during 8 sessions (range 3-28). They improved in 4 of 10 true-false knowledge statements about clinical trials. A patient navigation program for Chinese-speaking cancer patients is feasible. It results in high patient satisfaction rates and modest improvements in clinical trials knowledge and participation.

A video-based transdiagnostic REBT universal prevention program for internalizing problems in adolescents: study protocol of a cluster randomized controlled trial.

PubMed

Păsărelu, Costina Ruxandra; Dobrean, Anca

2018-04-13

Internalizing problems are the most prevalent mental health problems in adolescents. Transdiagnostic programs are promising manners to treat multiple problems within the same protocol, however, there is limited research regarding the efficacy of such programs delivered as universal prevention programs in school settings. Therefore, the present study aims to investigate the efficacy of a video-based transdiagnostic rational emotive behavioral therapy (REBT) universal prevention program, for internalizing problems. The second objective of the present paper will be to investigate the subsequent mechanisms of change, namely maladaptive cognitions. A two-arm parallel randomized controlled trial will be conducted, with two groups: a video-based transdiagnostic REBT universal prevention program and a wait list control. Power analysis indicated that the study will involve 338 participants. Adolescents with ages between 12 and 17 years old, from several middle schools and high schools, will be invited to participate. Assessments will be conducted at four time points: baseline (T 1 ), post-intervention (T 2 ), 3 months follow-up (T 3 ) and 12 months follow-up (T 4 ). Intent-to-treat analysis will be used in order to investigate significant differences between the two groups in both primary and secondary outcomes. This is the first randomized controlled trial that aims to investigate the efficacy and mechanisms of change of a video-based transdiagnostic REBT universal prevention program, delivered in a school context. The present study has important implications for developing efficient prevention programs, interactive, that will aim to target within the same protocol both anxiety and depressive symptoms. ClinicalTrials.gov: NCT02756507 . Registered on 25 April 2016.

Improving preschoolers' mathematics achievement with tablets: a randomized controlled trial

NASA Astrophysics Data System (ADS)

Schacter, John; Jo, Booil

2017-09-01

With a randomized field experiment of 433 preschoolers, we tested a tablet mathematics program designed to increase young children's mathematics learning. Intervention students played Math Shelf, a comprehensive iPad preschool and year 1 mathematics app, while comparison children received research-based hands-on mathematics instruction delivered by their classroom teachers. After 22 weeks, there was a large and statistically significant effect on mathematics achievement for Math Shelf students (Cohen's d = .94). Moderator analyses demonstrated an even larger effect for low achieving children (Cohen's d = 1.27). These results suggest that early education teachers can improve their students' mathematics outcomes by integrating experimentally proven tablet software into their daily routines.

Investigation of the external flow analysis for density measurements at high altitude. [shuttle upper atmosphere mass spectrometer experiment

NASA Technical Reports Server (NTRS)

Bienkowski, G. K.

1983-01-01

A Monte Carlo program was developed for modeling the flow field around the space shuttle in the vicinity of the shuttle upper atmosphere mass spectrometer experiment. The operation of the EXTERNAL code is summarized. Issues associated with geometric modeling of the shuttle nose region and the modeling of intermolecular collisions including rotational energy exchange are discussed as well as a preliminary analysis of vibrational excitation and dissociation effects. The selection of trial runs is described and the parameters used for them is justified. The original version and the modified INTERNAL code for the entrance problem are reviewed. The code listing is included.

Implementation of IT-based applications in the safeguards field

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

Ekenstam, G.C. af; Sallstrom, M.

1995-12-31

For many years the Swedish Nuclear Power Inspectorate, SKI, has used computers as a tool within nuclear material control and accountancy. Over the last five years a lot of effort has been put into projects related to the increasing possibilities of fast and reliable data transfer over large distances. The paper discusses related administrative and technical issues and presents experience gained in tasks of the Swedish Support Program to IAEA Safeguards and during the alternative Safeguards trials carried out by SKI. The following topics will be presented: (1) Main Safeguards purposes and data transfer; (2) Administrative systems and requirements; (3)more » Technical possibilities and experiences; and (4) The cost aspect.« less

Communications Specialist | Center for Cancer Research

Cancer.gov

Be part of our mission to support research against cancer. We have an exciting opportunity for a talented communicator to join our team and be part of the effort to find cures for cancer. We are looking for a creative, team-oriented communications professional, with strong writing skills to publicize our research advances, employment and training opportunities and clinical trials program. Work involves production of a monthly internal newsletter with circulation of 3,000, writing and editing a variety of stories, such as features on patients, and developing content for communications tactics. Must have a Bachelor’s degree in Communications, Biosciences and/or related field; Master’s degree or equivalent professional experience preferred. Full time position, business hours.

Field Trial Results of a 14-channel GPR Integrated with a U.S. Program for 3-D Utility Mapping

NASA Astrophysics Data System (ADS)

Anspach, James H.

2013-04-01

Existing underground utilities continue to be a leading cause of highway construction delay claims in the United States. Although 80-90% of existing utilities can typically be discovered and mapped using a wide range of geophysical tools, there is a recognizable need to improve the process. Existing shortcomings to the utility mapping process include a lack of viable depth attributes, long field occupation times, low experience level of the field technicians, and separate survey / geophysics functions. The U.S. National Academies and its Transportation Research Board recently concluded a project on alleviating the existing utility mapping shortcomings through the development of enhanced GPR. An existing commercial 400MHz 14-channel towed array was enhanced with positioning and interpretation hardware and software over a 3-year US 2M program. Field trials for effectiveness were conducted in a city suburb commercialized environment where the relative permittivity values averaged 9.4. The effectiveness of enhanced GPR was compared to traditional utility mapping techniques (Single Channel GPR, FDEM, Acoustic, Sondes, Gradiometric Magnetometers) during the project. The project area utilities included natural gas, water, electric, telephone, cable, storm, sanitary, traffic control, and several unknown function lines. Depths for these utilities were mostly unknown. 81% of known (from records and field appurtenance visual observation) utilities were detected via traditional geophysical means. These traditional geophysical means also detected 14% additional and previously "unknown" utilities. The enhanced GPR detected approximately 40% of the known and unknown utilities, and found an additional 6% of utilities that were previously undetected. These additional utilities were subsequently determined to be small diameter abandoned water and gas systems in very poor and broken condition. Although it did well with metallic water and gas lines, communication and electric utilities were mostly undetectable. Through a ground-truthing program of test holes to expose utilities, the depth values derived from the enhanced GPR were fairly consistent and within 15 cm of actual depth. The incomplete underground picture determined by the enhanced GPR reinforces previous studies that show that the mapping of existing underground utilities is a multi-tool effort that takes highly trained and skilled field technicians and data interpreters. The addition of a new GPR tool is valuable in determining continuous depth profiles of imaged utilities. A second and significant benefit is the interpretation of other geotechnical data that benefit project designers. This might include showing geometry, location, intensity, and depths of either areas of anomalies, or of known structures, such as paving thickness, substrate thickness, voids, water table, soil lenses, boulders, bedrock, and so forth. The Florida Department of Transportation has decided to take advantage of this new technology and has entered into an experimental contract with Cardno TBE to incorporate several enhanced GPR arrays with traditional utility detection tools. The goal of this contract will be to provide a 3-D model of existing underground utilities for use in automated construction. The GPR 3-D data model will be melded with conventional subsurface utility engineering and mapping practices and will be required to follow the ASCE 38 standard for utility data reliability.

Effectiveness of a Multi-Component Intervention for Overweight and Obese Children (Nereu Program): A Randomized Controlled Trial

PubMed Central

Serra-Paya, Noemi; Ensenyat, Assumpta; Castro-Viñuales, Iván; Real, Jordi; Sinfreu-Bergués, Xènia; Zapata, Amalia; Mur, Jose María; Galindo-Ortego, Gisela; Solé-Mir, Eduard; Teixido, Concepció

2015-01-01

Introduction Treatment of childhood obesity is a complex challenge for primary health care professionals. Objectives To evaluate the effectiveness of the Nereu Program in improving anthropometric parameters, physical activity and sedentary behaviours, and dietary intake. Methods Randomized, controlled, multicentre clinical trial comparing Nereu Program and usual counselling group interventions in primary care settings. The 8-month study recruited 113 children aged 6 to 12 years with overweight/obesity. Before recruitment, eligible participants were randomly allocated to an intensive, family-based multi-component behavioural intervention (Nereu Program group) or usual advice from their paediatrician on healthy eating and physical activity. Anthropometric parameters, objectively measured sedentary and physical activity behaviours, and dietary intake were evaluated pre- and post-intervention. Results At the end of the study period, both groups achieved a similar decrease in body mass index (BMIsd) compared to baseline. Nereu Program participants (n = 54) showed greater increases in moderate-intense physical activity (+6.27% vs. -0.61%, p<0.001) and daily fruit servings (+0.62 vs. +0.13, p<0.026), and decreased daily soft drinks consumption (-0.26 vs. -0.02, p<0.047), respectively, compared to the counselling group (n = 59). Conclusions At the end of the 8-month intervention, participants in the Nereu Program group showed improvement in physical activity and dietary behaviours, compared to the counselling group. Trial Registration ClinicalTrials.gov NCT01878994 PMID:26658988

In Defense of the Randomized Controlled Trial for Health Promotion Research

PubMed Central

Rosen, Laura; Manor, Orly; Engelhard, Dan; Zucker, David

2006-01-01

The overwhelming evidence about the role lifestyle plays in mortality, morbidity, and quality of life has pushed the young field of modern health promotion to center stage. The field is beset with intense debate about appropriate evaluation methodologies. Increasingly, randomized designs are considered inappropriate for health promotion research. We have reviewed criticisms against randomized trials that raise philosophical and practical issues, and we will show how most of these criticisms can be overcome with minor design modifications. By providing rebuttal to arguments against randomized trials, our work contributes to building a sound methodological base for health promotion research. PMID:16735622

Clinical Trial Design in Neuroendocrine Tumors.

PubMed

Halperin, Daniel M; Yao, James C

2016-02-01

Neuroendocrine tumors (NETs) present tremendous opportunities for productive clinical investigation, but substantial challenges as well. Investigators must be aware of common pitfalls in study design, informed by an understanding of the history of trials in the field, to make the best use of available data and our patient volunteers. We believe the salient issues in clinical trial design and interpretation in the NET field are patient homogeneity, standardized response assessment, and rigorous design and execution. Whether designing or interpreting a study in patients with NET, these principles should drive assessment. Copyright © 2016 Elsevier Inc. All rights reserved.

A National Cancer Clinical Trials Network: Recommendations from the Institute of Medicine

PubMed Central

Nass, Sharyl J.; Balogh, Erin; Mendelsohn, John

2010-01-01

Oncology has become one of the most active areas of drug discovery, with more than 800 cancer therapeutics in development. This presents an unprecedented opportunity to improve the outcome for patients with cancer, but also requires an effective and efficient clinical trials network to generate the evidence necessary for regulatory approval and optimal integration of new treatments into clinical care. The Clinical Trials Cooperative Group Program supported by the National Cancer Institute has been instrumental in establishing standards of care in oncology over the last 50 years, but it currently faces numerous challenges that threaten its ability to undertake the large-scale, multi-institutional trials that advance patient care. The Institute of Medicine recently appointed a consensus study committee to assess the organization and operation of the Cooperative Group Program and recommend ways to improve the quality of cancer clinical trials conducted by the Groups and others. The committee developed a set of recommendations, summarized here, that aim to improve the speed and efficiency of trials; incorporate innovative science and trial design; improve prioritization, selection, and support of trials; and increase participation by patients and physicians. PMID:21326081

NCTN Budget

Cancer.gov

Learn about the budget for the National Clinical Trials Network (NCTN), a National Cancer Institute program that gives funds and other support to cancer research organizations to conduct cancer clinical trials.

Treatment Algorithms Based on Tumor Molecular Profiling: The Essence of Precision Medicine Trials.

PubMed

Le Tourneau, Christophe; Kamal, Maud; Tsimberidou, Apostolia-Maria; Bedard, Philippe; Pierron, Gaëlle; Callens, Céline; Rouleau, Etienne; Vincent-Salomon, Anne; Servant, Nicolas; Alt, Marie; Rouzier, Roman; Paoletti, Xavier; Delattre, Olivier; Bièche, Ivan

2016-04-01

With the advent of high-throughput molecular technologies, several precision medicine (PM) studies are currently ongoing that include molecular screening programs and PM clinical trials. Molecular profiling programs establish the molecular profile of patients' tumors with the aim to guide therapy based on identified molecular alterations. The aim of prospective PM clinical trials is to assess the clinical utility of tumor molecular profiling and to determine whether treatment selection based on molecular alterations produces superior outcomes compared with unselected treatment. These trials use treatment algorithms to assign patients to specific targeted therapies based on tumor molecular alterations. These algorithms should be governed by fixed rules to ensure standardization and reproducibility. Here, we summarize key molecular, biological, and technical criteria that, in our view, should be addressed when establishing treatment algorithms based on tumor molecular profiling for PM trials. © The Author 2015. Published by Oxford University Press.

Estimating Single-Trial Responses in EEG

NASA Technical Reports Server (NTRS)

Shah, A. S.; Knuth, K. H.; Truccolo, W. A.; Mehta, A. D.; Fu, K. G.; Johnston, T. A.; Ding, M.; Bressler, S. L.; Schroeder, C. E.; Clancy, Daniel (Technical Monitor)

2002-01-01

Accurate characterization of single-trial field potential responses is critical from a number of perspectives. For example, it allows differentiation of an evoked response from ongoing EEG. We previously developed the multiple component Event Related Potential (mcERP) algorithm to improve resolution of the single-trial evoked response. The mcERP model states that multiple components, each specified by a stereotypic waveform varying in latency and amplitude from trial to trial, comprise the evoked response. Application of the mcERP algorithm to simulated data with three independent, synthetic components has shown that the model is capable of separating these components and estimating their variability. Application of the model to single trial, visual evoked potentials recorded simultaneously from all V1 laminae in an awake, fixating macaque yielded local and far-field components. Certain local components estimated by the model were distributed in both granular and supragranular laminae. This suggests a linear coupling between the responses of thalamo-recipient neuronal ensembles and subsequent responses of supragranular neuronal ensembles, as predicted by the feedforward anatomy of V1. Our results indicate that the mcERP algorithm provides a valid estimation of single-trial responses. This will enable analyses that depend on trial-to-trial variations and those that require separation of the evoked response from background EEG rhythms

SOME DESIGN ISSUES IN PHASE 2B VERSUS PHASE 3 PREVENTION TRIALS FOR TESTING EFFICACY OF PRODUCTS OR CONCEPTS

PubMed Central

Gilbert, Peter B.

2009-01-01

SUMMARY After one or more Phase 2 trials show that a candidate preventive vaccine induces immune responses that putatively protect against an infectious disease for which there is no licensed vaccine, the next step is to evaluate the efficacy of the candidate. The trial-designer faces the question of what is the optimal size of the initial efficacy trial? Part of the answer will entail deciding between a large Phase 3 licensure trial or an intermediate-sized Phase 2b screening trial, the latter of which may be designed to directly contribute to the evidence-base for licensing the candidate, or, to test a scientific concept for moving the vaccine field forward, acknowledging that the particular candidate will never be licensable. Using the HIV vaccine field as a case study, we describe distinguishing marks of Phase 2b and Phase 3 prevention efficacy trials, and compare the expected utility of these trial types using Pascal’s decision-theoretic framework. By integrating values/utilities on (1) Correct or incorrect conclusions resulting from the trial; (2) Timeliness of obtaining the trial results; (3) Precision for estimating the intervention effect; and (4) Resources expended; this decision framework provides a more complete approach to selecting the optimal efficacy trial size than a traditional approach that is based primarily on power calculations. Our objective is to help inform the decision-process for planning an initial efficacy trial design. PMID:20419758

Variability of pesticide residues in eggplant units collected from a field trial and marketplaces in Greece.

PubMed

Prodhan, Mohammad Dalower Hossain; Papadakis, Emmanouil-Nikolaos; Papadopoulou-Mourkidou, Euphemia

2018-04-01

Variability of pesticide residues among food items is very important when assessing the risks and food safety for the consumers. Therefore, the present study was undertaken to estimate the unit-to-unit residue variability factors for eggplant. In total, 120 samples from a trial field and 142 samples from different marketplaces in Thessaloniki, Greece, were collected to estimate the variability of pesticide residues in eggplant units. They were extracted by the QuEChERS method and the residues were determined by LC-MS/MS. For the field samples, the unit-to-unit variability factors (VFs) obtained for cypermethrin and deltamethrin residues were 2.54 and 2.51, respectively. The mean residue levels of both pesticides were higher in the composite samples than in the individual samples. The average VFs for the marketplace samples was 3.89. The eggplant units exposed to pesticides were higher in residues than the non-exposed units. The variability factors obtained in the marketplace samples were higher than those in the samples collected from the field trial. A default VF value of 3 for field trials is appropriate for use when assessing the acute dietary intake but a VF for the marketplace samples should be reconsidered with a larger data. © 2017 Society of Chemical Industry. © 2017 Society of Chemical Industry.

Implementation of a children's hospital-wide central venous catheter insertion and maintenance bundle.

PubMed

Helder, Onno; Kornelisse, René; van der Starre, Cynthia; Tibboel, Dick; Looman, Caspar; Wijnen, René; Poley, Marten; Ista, Erwin

2013-10-14

Central venous catheter-associated bloodstream infections in children are an increasingly recognized serious safety problem worldwide, but are often preventable. Central venous catheter bundles have proved effective to prevent such infections. Successful implementation requires changes in the hospital system as well as in healthcare professionals' behaviour. The aim of the study is to evaluate process and outcome of implementation of a state-of-the-art central venous catheter insertion and maintenance bundle in a large university children's hospital. An interrupted time series design will be used; the study will encompass all children who need a central venous catheter. New state-of-the-art central venous catheter bundles will be developed. The Pronovost-model will guide the implementation process. We developed a tailored multifaceted implementation strategy consisting of reminders, feedback, management support, local opinion leaders, and education. Primary outcome measure is the number of catheter-associated infections per 1000 line-days. The process outcome is degree of adherence to use of these central venous catheter bundles is the secondary outcome. A cost-effectiveness analysis is part of the study. Outcomes will be monitored during three periods: baseline, pre-intervention, and post-intervention for over 48 months. This model-based implementation strategy will reveal the challenges of implementing a hospital-wide safety program. This work will add to the body of knowledge in the field of implementation. We postulate that healthcare workers' willingness to shift from providing habitual care to state-of-the-art care may reflect the need for consistent care improvement. Trial registration: Dutch trials registry, trial # 3635. Dutch trials registry (http://www.trialregister.nl), trial # 3635.

Parametric models to relate spike train and LFP dynamics with neural information processing.

PubMed

Banerjee, Arpan; Dean, Heather L; Pesaran, Bijan

2012-01-01

Spike trains and local field potentials (LFPs) resulting from extracellular current flows provide a substrate for neural information processing. Understanding the neural code from simultaneous spike-field recordings and subsequent decoding of information processing events will have widespread applications. One way to demonstrate an understanding of the neural code, with particular advantages for the development of applications, is to formulate a parametric statistical model of neural activity and its covariates. Here, we propose a set of parametric spike-field models (unified models) that can be used with existing decoding algorithms to reveal the timing of task or stimulus specific processing. Our proposed unified modeling framework captures the effects of two important features of information processing: time-varying stimulus-driven inputs and ongoing background activity that occurs even in the absence of environmental inputs. We have applied this framework for decoding neural latencies in simulated and experimentally recorded spike-field sessions obtained from the lateral intraparietal area (LIP) of awake, behaving monkeys performing cued look-and-reach movements to spatial targets. Using both simulated and experimental data, we find that estimates of trial-by-trial parameters are not significantly affected by the presence of ongoing background activity. However, including background activity in the unified model improves goodness of fit for predicting individual spiking events. Uncovering the relationship between the model parameters and the timing of movements offers new ways to test hypotheses about the relationship between neural activity and behavior. We obtained significant spike-field onset time correlations from single trials using a previously published data set where significantly strong correlation was only obtained through trial averaging. We also found that unified models extracted a stronger relationship between neural response latency and trial-by-trial behavioral performance than existing models of neural information processing. Our results highlight the utility of the unified modeling framework for characterizing spike-LFP recordings obtained during behavioral performance.

Soil fumigation to control spread of Fomes annosus: results of field trials

Treesearch

David R. Houston

1975-01-01

A field trial was run to test the hypothesis that a band of roots killed by soil fumigation with methyl bromide would be unsuitable for invasion by F. annosus and would block the underground spread of the fungus from diseased trees to healthy trees. Infection centers in red pine plantations from New York to Rhode Island were delineated on the basis...

Social Effects on Rat Spatial Choice in an Open Field Task

ERIC Educational Resources Information Center

Keller, Matthew R.; Brown, Michael F.

2011-01-01

Pairs of rats foraged in trials either together or separately in an open field apparatus for pellets hidden in discreet locations in a 5 x 5 matrix. Trial duration was either 1 or 4 min. The tendency to choose locations that had earlier been visited by another rat was examined by comparing the choices made in the presence and absence of the other…

Design and implementation of a fault-tolerant and dynamic metadata database for clinical trials

NASA Astrophysics Data System (ADS)

Lee, J.; Zhou, Z.; Talini, E.; Documet, J.; Liu, B.

2007-03-01

In recent imaging-based clinical trials, quantitative image analysis (QIA) and computer-aided diagnosis (CAD) methods are increasing in productivity due to higher resolution imaging capabilities. A radiology core doing clinical trials have been analyzing more treatment methods and there is a growing quantity of metadata that need to be stored and managed. These radiology centers are also collaborating with many off-site imaging field sites and need a way to communicate metadata between one another in a secure infrastructure. Our solution is to implement a data storage grid with a fault-tolerant and dynamic metadata database design to unify metadata from different clinical trial experiments and field sites. Although metadata from images follow the DICOM standard, clinical trials also produce metadata specific to regions-of-interest and quantitative image analysis. We have implemented a data access and integration (DAI) server layer where multiple field sites can access multiple metadata databases in the data grid through a single web-based grid service. The centralization of metadata database management simplifies the task of adding new databases into the grid and also decreases the risk of configuration errors seen in peer-to-peer grids. In this paper, we address the design and implementation of a data grid metadata storage that has fault-tolerance and dynamic integration for imaging-based clinical trials.

Establishing the effectiveness, cost-effectiveness and student experience of a Simulation-based education Training program On the Prevention of Falls (STOP-Falls) among hospitalised inpatients: a protocol for a randomised controlled trial

PubMed Central

Williams, Cylie; Kiegaldie, Debra; Kaplonyi, Jessica; Haines, Terry

2016-01-01

Introduction Simulation-based education (SBE) is now commonly used across health professional disciplines to teach a range of skills. The evidence base supporting the effectiveness of this approach for improving patient health outcomes is relatively narrow, focused mainly on the development of procedural skills. However, there are other simulation approaches used to support non-procedure specific skills that are in need of further investigation. This cluster, cross-over randomised controlled trial with a concurrent economic evaluation (cost per fall prevented) trial will evaluate the effectiveness, cost-effectiveness and student experience of health professional students undertaking simulation training for the prevention of falls among hospitalised inpatients. This research will target the students within the established undergraduate student placements of Monash University medicine, nursing and allied health across Peninsula Health acute and subacute inpatient wards. Methods and analysis The intervention will train the students in how to provide the Safe Recovery program, the only single intervention approach demonstrated to reduce falls in hospitals. This will involve redevelopment of the Safe Recovery program into a one-to-many participant SBE program, so that groups of students learn the communication skills and falls prevention knowledge necessary for delivery of the program. The primary outcome of this research will be patient falls across participating inpatient wards, with secondary outcomes including student satisfaction with the SBE and knowledge gain, ward-level practice change and cost of acute/rehabilitation care for each patient measured using clinical costing data. Ethics and dissemination The Human Research Ethics Committees of Peninsula Health (LRR/15/PH/11) and Monash University (CF15/3523-2015001384) have approved this research. The participant information and consent forms provide information on privacy, storage of results and dissemination. Registration of this trial has been completed with the Australian and New Zealand Clinical Trials Registry: ACTRN12615000817549. This study protocol has been prepared according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist. Trial registration number ACTRN12615000817549; Pre-results. PMID:27256087

Programs for the Prevention of Youth Depression: Evaluation of Efficacy, Effectiveness, and Readiness for Dissemination

PubMed Central

Brunwasser, Steven M.; Garber, Judy

2015-01-01

Objective To evaluate the current state of evidence of the effectiveness of depression prevention programs for youth, assess the degree to which current evidence supports broad implementation, and outline additional steps needed to close the gap between effectiveness and dissemination. Method We used the Society for Prevention Research’s Standards of Evidence (Flay et al., 2005) to evaluate the degree to which existing depression prevention programs have established intervention efficacy, effectiveness, and readiness for dissemination. We reviewed all depression prevention programs for youth that have been evaluated in at least two published, randomized controlled trials in which the intervention was compared to a no-intervention control group. A total of 37 studies evaluating 11 different programs were reviewed with regard to depressive symptoms and diagnoses post intervention and at follow-up (at least 6 months). Results Eight programs demonstrated significant main effects on depressive symptoms relative to controls in multiple RCTs; five programs had at least one trial with significant main effects present at least one year post-intervention. Two programs demonstrated efficacy for both depressive symptoms and depressive episodes across multiple independent trials. Regarding effectiveness, six programs had at least one study showing significant effects when delivered by endogenous service providers; four programs had significant effects in studies conducted independently of the program developers. Conclusions Several programs have demonstrated promise in terms of efficacy, but no depression prevention program for children or adolescents as yet has garnered sufficient evidence of effectiveness under real-world conditions to warrant widespread dissemination at this time. PMID:25933173