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Sample records for before-after implementation trial

  1. A before-after implementation trial of smoking cessation guidelines in hospitalized veterans

    Directory of Open Access Journals (Sweden)

    Reisinger Heather

    2009-09-01

    intervention and baseline periods, we will use random effects logistic regression models, which take the clustered nature of the data within nurses and hospitals into account. We will assess attitudes of staff nurses toward cessation counseling by questionnaire and will identify barriers and facilitators to implementation by using clinician focus groups. To determine the short-term incremental cost per quitter from the perspective of the VA health care system, we will calculate cessation-related costs incurred during the initial hospitalization and six-month follow-up period. Trial number NCT00816036

  2. Reduction in gastrointestinal bleeding by development and implementation of a protocol for stress ulcer prophylaxis: a before-after study

    OpenAIRE

    Ikemura, Mai; Nakasako, Shinji; Seo, Ryutaro; Atsumi, Takahiro; Ariyoshi, Koichi; Hashida, Tohru

    2015-01-01

    Background The implementation of a protocol has been associated with improvements in the processes of care in clinical settings. Although stress ulcer prophylaxis is recommended for critically ill patients at high risk, there is currently no consensus on its use. Therefore, we herein developed a protocol for stress ulcer prophylaxis, and evaluated therapeutic outcomes in a before-after study. Methods The protocol was developed by considering the effectiveness, disadvantages (including adverse...

  3. Implementing hospital guidelines improves warfarin use in non-valvular atrial fibrillation: a before-after study

    Directory of Open Access Journals (Sweden)

    Piobbici Marina

    2007-08-01

    Full Text Available Abstract Background The use of oral anticoagulant therapy (OAT to prevent non-valvular atrial fibrillation (NVAF related-strokes is often sub-optimal. We aimed to evaluate whether implementing guidelines on antithrombotic therapy (AT by a multifaceted strategy may improve appropriateness of its prescription in NVAF-patients discharged from a large tertiary-care hospital. Methods A survey was conducted on all consecutive NVAF patients discharged before (1st January–30th June 2000, n = 313 and after (1st January–30th June 2004, n = 388 guideline development and implementation. Results When strongly recommended, OAT use increased from 56.6% (60/106 in 2000 to 81.9% (86/105 in 2004, with an absolute difference of +25.3% (95%CI: 15% 35%. In patients for whom the choice OAT/acetylsalicylic acid should be individualised, those discharged without any AT were 33.7% (34/101 in 2000 and 16.9% (21/124 in 2004 (-16.7%;95%CI: -26.2% -7.2%. In a logistic regression model, OAT prescription in 2004 was increased by 2.11 times (95%CI: 1.47 3.04, after accounting for stroke risk, presence of contraindications (OR = 0.18; 0.13 0.27, older age (OR = 0.30; 0.21 0.45, prophylaxis at admission (OR = 3.03; 2.08 4.43. OAT was positively associated with the stroke risk in the 2004 sample only. Conclusion The guideline implementation has substantially improved the appropriateness of OAT at discharge, through a better evaluation at patient's individual level of the benefit-to-risk ratio.

  4. Reduction of anti-malarial consumption after rapid diagnostic tests implementation in Dar es Salaam: a before-after and cluster randomized controlled study

    Directory of Open Access Journals (Sweden)

    Swai Ndeniria

    2011-04-01

    Full Text Available Abstract Background Presumptive treatment of all febrile patients with anti-malarials leads to massive over-treatment. The aim was to assess the effect of implementing malaria rapid diagnostic tests (mRDTs on prescription of anti-malarials in urban Tanzania. Methods The design was a prospective collection of routine statistics from ledger books and cross-sectional surveys before and after intervention in randomly selected health facilities (HF in Dar es Salaam, Tanzania. The participants were all clinicians and their patients in the above health facilities. The intervention consisted of training and introduction of mRDTs in all three hospitals and in six HF. Three HF without mRDTs were selected as matched controls. The use of routine mRDT and treatment upon result was advised for all patients complaining of fever, including children under five years of age. The main outcome measures were: (1 anti-malarial consumption recorded from routine statistics in ledger books of all HF before and after intervention; (2 anti-malarial prescription recorded during observed consultations in cross-sectional surveys conducted in all HF before and 18 months after mRDT implementation. Results Based on routine statistics, the amount of artemether-lumefantrine blisters used post-intervention was reduced by 68% (95%CI 57-80 in intervention and 32% (9-54 in control HF. For quinine vials, the reduction was 63% (54-72 in intervention and an increase of 2.49 times (1.62-3.35 in control HF. Before-and-after cross-sectional surveys showed a similar decrease from 75% to 20% in the proportion of patients receiving anti-malarial treatment (Risk ratio 0.23, 95%CI 0.20-0.26. The cluster randomized analysis showed a considerable difference of anti-malarial prescription between intervention HF (22% and control HF (60% (Risk ratio 0.30, 95%CI 0.14-0.70. Adherence to test result was excellent since only 7% of negative patients received an anti-malarial. However, antibiotic

  5. New generation of breast cancer clinical trials implementing molecular profiling

    Institute of Scientific and Technical Information of China (English)

    Dimitrios Zardavas; Martine Piccart-Gebhart

    2016-01-01

    The implementation of molecular profiling technologies in oncology deepens our knowledge for the molecular landscapes of cancer diagnoses, identifying aberrations that could be linked with specific therapeutic vulnerabilities. In particular, there is an increasing list of molecularly targeted anticancer agents undergoing clinical development that aim to block specific molecular aberrations. This leads to a paradigm shift, with an increasing list of specific aberrations dictating the treatment of patients with cancer. This paradigm shift impacts the field of clinical trials, since the classical approach of having clinico-pathological disease characteristics dictating the patients' enrolment in oncology trials shifts towards the implementation of molecular profiling as pre-screening step. In order to facilitate the successful clinical development of these new anticancer drugs within specific molecular niches of cancer diagnoses, there have been developed new, innovative trial designs that could be classified as follows: i) longitudinal cohort studies that implement (or not) "nested" downstream trials, 2) studies that assess the clinical utility of molecular profiling, 3) "master" protocol trials, iv) "basket" trials, v) trials following an adaptive design. In the present article, we review these innovative study designs, providing representative examples from each category and we discuss the challenges that still need to be addressed in this era of new generation oncology trials implementing molecular profiling. Emphasis is put on the field of breast cancer clinical trials.

  6. Effects of Transcendental Meditation on mental health: a before-after study

    OpenAIRE

    Vash Javad; Aslani Afshin; Yunesian Masud; Yazdi Abbas

    2008-01-01

    Abstract Background Transcendental Meditation is a mental practice to put the body and mind into a state of relaxation and rest. The method was shown to reduce anxiety and stress in previous reports. This study investigates its potential benefits in enhancing mental health of an adult Muslim population. Methods A before-after clinical trial was conducted to evaluate the effect of a 12-week meditation course on mental health of participants who were enrolled into the study by random sampling. ...

  7. A pragmatic cluster randomised trial evaluating three implementation interventions

    Directory of Open Access Journals (Sweden)

    Rycroft-Malone Jo

    2012-08-01

    Full Text Available Abstract Background Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting. Methods A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA. The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients’ experiences, and stakeholders’ experiences of implementation, including influences. ANOVA was used to test differences over time and interventions. Results Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility. Conclusions This was a large, complex study and one of the first

  8. Effects of Transcendental Meditation on mental health: a before-after study

    Directory of Open Access Journals (Sweden)

    Vash Javad

    2008-11-01

    Full Text Available Abstract Background Transcendental Meditation is a mental practice to put the body and mind into a state of relaxation and rest. The method was shown to reduce anxiety and stress in previous reports. This study investigates its potential benefits in enhancing mental health of an adult Muslim population. Methods A before-after clinical trial was conducted to evaluate the effect of a 12-week meditation course on mental health of participants who were enrolled into the study by random sampling. 28-item General Health Questionnaire (GHQ was administered on two occasions in conjunction with a background data sheet. Results Mean age of participants was 32.4; they were 70% female and 55% married. GHQ scores improved significantly after the meditation course (p value: Conclusion Transcendental Meditation may improve mental health of young adult population especially in the areas of somatisation and anxiety, and this effect seems to be independent of age, sex and marital status.

  9. Measuring the impact and costs of a universal group based parenting programme: protocol and implementation of a trial

    Directory of Open Access Journals (Sweden)

    Winstanley Sarah

    2010-06-01

    Full Text Available Abstract Background Sub-optimal parenting is a common risk factor for a wide range of negative health, social and educational outcomes. Most parenting programmes have been developed in the USA in the context of delinquency prevention for targeted or indicated groups and the main theoretical underpinning for these programmes is behaviour management. The Family Links Nurturing Programme (FLNP focuses on family relationships as well as behaviour management and is offered on a universal basis. As a result it may be better placed to improve health and educational outcomes. Developed in the UK voluntary sector, FLNP is popular with practitioners, has impressed policy makers throughout the UK, has been found to be effective in before/after and qualitative studies, but lacks a randomised controlled trial (RCT evidence base. Methods/Design A multi-centre, investigator blind, randomised controlled trial of the FLNP with a target sample of 288 south Wales families who have a child aged 2-4 yrs living in or near to Flying Start/Sure Start areas. Changes in parenting, parent child relations and parent and child wellbeing are assessed with validated measures immediately and at 6 months post intervention. Economic components include cost consequences and cost utility analyses based on parental ranking of states of quality of life. Attendance and completion rates and fidelity to the FLNP course delivery are assessed. A nested qualitative study will assess reasons for participation and non-participation and the perceived value of the programme to families. By the end of May 2010, 287 families have been recruited into the trial across four areas of south Wales. Recruitment has not met the planned timescales with barriers including professional anxiety about families entering the control arm of the trial, family concern about video and audio recording, programme facilitator concern about the recording of FLNP sessions for fidelity purposes and delays due to the

  10. Practical considerations for adaptive trial design and implementation

    CERN Document Server

    Pinheiro, José; Kuznetsova, Olga

    2014-01-01

    This edited volume is a definitive text on adaptive clinical trial designs from creation and customization to utilization. As this book covers the full spectrum of topics involved in the adaptive designs arena, it will serve as a valuable reference for researchers working in industry, government and academia. The target audience is anyone involved in the planning and execution of clinical trials, in particular, statisticians, clinicians, pharmacometricians, clinical operation specialists, drug supply managers, and infrastructure providers.  In spite of the increased efficiency of adaptive trials in saving costs and time, ultimately getting drugs to patients sooner, their adoption in clinical development is still relatively low.  One of the chief reasons is the higher complexity of adaptive design trials as compared to traditional trials. Barriers to the use of clinical trials with adaptive features include the concerns about the integrity of study design and conduct, the risk of regulatory non-acceptance, t...

  11. Implementation of the NCI’s National Clinical Trials Network

    Science.gov (United States)

    NCI is launching a new clinical trials research network intended to improve treatment for the more than 1.6 million Americans diagnosed with cancer each year. The new system, NCI’s National Clinical Trials Network (NCTN), will facilitate the rapid initia

  12. Implementing a complex rehabilitation intervention in a stroke trial: a qualitative process evaluation of AVERT

    OpenAIRE

    Luker, Julie A; Craig, Louise E; Bennett, Leanne; Ellery, Fiona; Langhorne, Peter; Wu, Olivia; Bernhardt, Julie

    2016-01-01

    Background The implementation of multidisciplinary stroke rehabilitation interventions is challenging, even when the intervention is evidence-based. Very little is known about the implementation of complex interventions in rehabilitation clinical trials. The aim of study was to better understand how the implementation of a rehabilitation intervention in a clinical trial within acute stroke units is experienced by the staff involved. This qualitative process evaluation was part of a large Phas...

  13. Implementing a complex rehabilitation intervention in a stroke trial: a qualitative process evaluation of AVERT

    OpenAIRE

    Luker, Julie A; Craig, Louise E; Bennett, Leanne; Ellery, Fiona; Langhorne, Peter; Wu, Olivia; Bernhardt, Julie

    2016-01-01

    Background The implementation of multidisciplinary stroke rehabilitation interventions is challenging, even when the intervention is evidence-based. Very little is known about the implementation of complex interventions in rehabilitation clinical trials. The aim of study was to better understand how the implementation of a rehabilitation intervention in a clinical trial within acute stroke units is experienced by the staff involved. This qualitative process evaluation was part of a lar...

  14. Impact of Video Self-Monitoring with Graduated Training on Implementation of Embedded Instructional Learning Trials

    Science.gov (United States)

    Bishop, Crystal D.; Snyder, Patricia A.; Crow, Robert E.

    2015-01-01

    We used a multi-component single-subject experimental design across three preschool teachers to examine the effects of video self-monitoring with graduated training and feedback on the accuracy with which teachers monitored their implementation of embedded instructional learning trials. We also examined changes in teachers' implementation of…

  15. Training Parent Implementation of Discrete-Trial Teaching: Effects on Generalization of Parent Teaching and Child Correct Responding

    OpenAIRE

    Lafasakis, Michael; Sturmey, Peter

    2007-01-01

    Behavioral skills training was used to teach 3 parents to implement discrete-trial teaching with their children with developmental disabilities. Parents learned to implement discrete-trial training, their skills generalized to novel programs, and the children's correct responding increased, suggesting that behavioral skills training is an effective and efficient method of teaching discrete-trial teaching to parents.

  16. Common before-after accident study on a road site: a low-informative Bayesian method

    OpenAIRE

    Brenac, Thierry

    2009-01-01

    This note aims at providing a Bayesian methodological basis for routine before-after accident studies, often applied to a single road site, and in conditions of limited resources in terms of time and expertise. Methods: A low-informative Bayesian method is proposed for before-after accident studies using a comparison site or group of sites. As compared to conventional statistics, the Bayesian approach is less subject to misuse and misinterpretation by practitioners. The low-informative framew...

  17. Telephone care coordination for smokers in VA mental health clinics: protocol for a hybrid type-2 effectiveness-implementation trial

    OpenAIRE

    Rogers, Erin; Fernandez, Senaida; Gillespie, Colleen; Smelson, David; Hagedorn, Hildi J; Elbel, Brian; Kalman, David; Axtmayer, Alfredo; Kurowski, Karishma; Sherman, Scott E

    2013-01-01

    Background This paper describes an innovative protocol for a type-II hybrid effectiveness-implementation trial that is evaluating a smoking cessation telephone care coordination program for Veterans Health Administration (VA) mental-health clinic patients. As a hybrid trial, the protocol combines implementation science and clinical trial methods and outcomes that can inform future cessation studies and the implementation of tobacco cessation programs into routine care. The primary objectives ...

  18. Design and implementation of a fault-tolerant and dynamic metadata database for clinical trials

    Science.gov (United States)

    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.

  19. Training Parent Implementation of Discrete-Trial Teaching: Effects on Generalization of Parent Teaching and Child Correct Responding

    Science.gov (United States)

    Lafasakis, Michael; Sturmey, Peter

    2007-01-01

    Behavioral skills training was used to teach 3 parents to implement discrete-trial teaching with their children with developmental disabilities. Parents learned to implement discrete-trial training, their skills generalized to novel programs, and the children's correct responding increased, suggesting that behavioral skills training is an…

  20. THE IMPACT OF THE BEFORE-AFTER ERROR TERM CORRELATION ON WELFARE MEASUREMENT IN LOGIT

    OpenAIRE

    Paolo Delle Site; Marco Valerio Salucci

    2012-01-01

    We consider random utility models with independent and identical type I extreme value distribution of the error terms. To compute the expectation of the compensating variation it is necessary to consider the correlation of the error terms between the state before the price and quality change and the state after. We investigate the impact of the before-after correlation of the error terms on the expectation of the compensating variation. We consider each error term to be correlated between the...

  1. Partnering with health system operations leadership to develop a controlled implementation trial

    OpenAIRE

    Bauer, Mark S.; Miller, Christopher; Kim, Bo; Lew, Robert; Weaver, Kendra; Coldwell, Craig; Henderson, Kathy; Holmes, Sally; Seibert, Marjorie Nealon; STOLZMANN, KELLY; Elwy, A. Rani; Kirchner, JoAnn

    2016-01-01

    Background: Outcome for mental health conditions is suboptimal, and care is fragmented. Evidence from controlled trials indicates that collaborative chronic care models (CCMs) can improve outcomes in a broad array of mental health conditions. US Department of Veterans Affairs leadership launched a nationwide initiative to establish multidisciplinary teams in general mental health clinics in all medical centers. As part of this effort, leadership partnered with implementation researchers to de...

  2. An effectiveness-implementation hybrid trial study protocol targeting posttraumatic stress disorder and comorbidity

    OpenAIRE

    Zatzick, Douglas F.; Russo, Joan; Darnell, Doyanne; Chambers, David A.; Palinkas, Lawrence; Van Eaton, Erik; Wang, Jin; Ingraham, Leah M.; Guiney, Roxanne; Heagerty, Patrick; Comstock, Bryan; Whiteside, Lauren K.; Jurkovich, Gregory

    2016-01-01

    Background Each year in the USA, 1.5–2.5 million Americans are so severely injured that they require inpatient hospitalization. Multiple conditions including posttraumatic stress disorder (PTSD), alcohol and drug use problems, depression, and chronic medical conditions are endemic among physical trauma survivors with and without traumatic brain injuries. Methods/design The trauma survivors outcomes and support (TSOS) effectiveness-implementation hybrid trial is designed to test the delivery o...

  3. A trial of distributed portable data acquisition and processing system implementation: the qdpb - data processing with branchpoints

    International Nuclear Information System (INIS)

    A trial of distributed portable data acquisition and processing system qdpb is issued. An experimental setup data and hardware dependent code is separated from the generic part of the qdpb system. The generic part implementation is described

  4. Tailored Implementation for Chronic Diseases (TICD): a protocol for process evaluation in cluster randomized controlled trials in five European countries

    OpenAIRE

    Jäger, Cornelia; Freund, Tobias; Steinhäuser, Jost; Aakhus, Eivind; Flottorp, Signe; Godycki-Cwirko, Maciek; van Lieshout, Jan; Krause, Jane; Szecsenyi, Joachim; Wensing, Michel

    2014-01-01

    Background In the ‘Tailored Implementation for Chronic Diseases (TICD)’ project, five tailored implementation programs to improve healthcare delivery in different chronic conditions have been developed. These programs will be evaluated in distinct cluster-randomized controlled trials. This protocol describes the process evaluation across these trials, which aims to identify determinants of change in chronic illness care, to examine the validity of the tailoring methods that were applied, and ...

  5. Estimating population impacts via dynamic occupancy analysis of Before-After Control-Impact studies.

    Science.gov (United States)

    Popescu, Viorel D; de Valpine, Perry; Tempel, Douglas; Peery, M Zachariah

    2012-06-01

    Estimating environmental impacts on populations is one of the main goals of wildlife monitoring programs, which are often conducted in conjunction with management actions or following natural disturbances. In this study we investigate the statistical power of dynamic occupancy models to detect changes in local survival and colonization from detection-nondetection data, while accounting for imperfect detection probability, in a Before-After Control-Impact (BACI) framework. We simulated impacts on local survival and/or detection probabilities, and asked questions related to: (1) costs and benefits of different analysis models, (2) confounding changes in detection with changes in local survival, (3) sampling design trade-offs, and (4) species with low vs. high rates of turnover. Estimating seasonal effects on local survival and colonization, as opposed to estimating Before-After effects, had little effect on the power to detect changes in local survival. Estimating a parameter that accounted for pretreatment differences in local survival between Control and Impact sites decreased power by 50%, but it was critical to include when such differences existed. When the experimental treatment had a negative impact on species detectability but analysis assumed constant detection, the Type I error rates were dramatically inflated (0.20 0.33). In general, there was low power (researchers are confident that major treatment impacts will occur or very large sample sizes are obtainable. PMID:22827142

  6. Autonomous Precision Spraying Trials Using a Novel Cell Spray Implement Mounted on an Armadillo Tool Carrier

    DEFF Research Database (Denmark)

    Jensen, Kjeld; Stigaard Laursen, Morten; Midtiby, Henrik;

    Precision weeding is one of the most promising applications for autonomous service robots in biological production. Herbicides have been the default weeding solution during the past decades, but there is a growing concern about the environmental impact on drinking water reservoirs etc. The use...... of computer vision and precision spraying technology makes it possible to significantly reduce the consumption of herbicides. The work presented here is part of a project with the purpose of performing autonomous precision spraying trials. In this work a novel cell sprayer designed for large scale tests...... with an Armadillo robotic tool carrier consisting of two battery powered track modules mounted on each side of the implement. This paper focus on the cell sprayer implement design including camera system, sprayer module and integration with the service robot and the robot software. The FroboMind software platform...

  7. Design and Implementation of a Randomized Controlled Trial of Genomic Counseling for Patients with Chronic Disease

    Directory of Open Access Journals (Sweden)

    Kevin Sweet

    2014-01-01

    Full Text Available We describe the development and implementation of a randomized controlled trial to investigate the impact of genomic counseling on a cohort of patients with heart failure (HF or hypertension (HTN, managed at a large academic medical center, the Ohio State University Wexner Medical Center (OSUWMC. Our study is built upon the existing Coriell Personalized Medicine Collaborative (CPMC®. OSUWMC patient participants with chronic disease (CD receive eight actionable complex disease and one pharmacogenomic test report through the CPMC® web portal. Participants are randomized to either the in-person post-test genomic counseling—active arm, versus web-based only return of results—control arm. Study-specific surveys measure: (1 change in risk perception; (2 knowledge retention; (3 perceived personal control; (4 health behavior change; and, for the active arm (5, overall satisfaction with genomic counseling. This ongoing partnership has spurred creation of both infrastructure and procedures necessary for the implementation of genomics and genomic counseling in clinical care and clinical research. This included creation of a comprehensive informed consent document and processes for prospective return of actionable results for multiple complex diseases and pharmacogenomics (PGx through a web portal, and integration of genomic data files and clinical decision support into an EPIC-based electronic medical record. We present this partnership, the infrastructure, genomic counseling approach, and the challenges that arose in the design and conduct of this ongoing trial to inform subsequent collaborative efforts and best genomic counseling practices.

  8. Implementing referral to an electronic alcohol brief advice website in primary healthcare: results from the ODHIN implementation trial

    Science.gov (United States)

    Bendtsen, Preben; Müssener, Ulrika; Karlsson, Nadine; López-Pelayo, Hugo; Palacio-Vieira, Jorge; Colom, Joan; Gual, Antoni; Reynolds, Jillian; Wallace, Paul; Segura, Lidia; Anderson, Peter

    2016-01-01

    Objectives The objective of the present study was to explore whether the possibility of offering facilitated access to an alcohol electronic brief intervention (eBI) instead of delivering brief face-to-face advice increased the proportion of consulting adults who were screened and given brief advice. Design The study was a 12-week implementation study. Sixty primary healthcare units (PHCUs) in 5 jurisdictions (Catalonia, England, the Netherlands, Poland and Sweden) were asked to screen adults who attended the PHCU for risky drinking. Setting A total of 120 primary healthcare centres from 5 jurisdictions in Europe. Participants 746 individual providers (general practitioners, nurses or other professionals) participated in the study. Primary outcome Change in the proportion of patients screened and referred to eBI comparing a baseline 4-week preimplementation period with a 12-week implementation period. Results The possibility of referring patients to the eBI was not found to be associated with any increase in the proportion of patients screened. However, it was associated with an increase in the proportion of screen-positive patients receiving brief advice from 70% to 80% for the screen-positive sample as a whole (ptechnology. Staff continued to offer face-to-face advice to a larger proportion of patients (54%) than referral to eBI (38%). In addition, low engagement was seen among the referred patients; on average, 18% of the patients logged on to the website with a mean log-on rate across the different countries between 0.58% and 36.95%. Conclusions Referral to eBI takes nearly as much time as brief oral advice and might require more introduction and training before staff are comfortable with referring to eBI. Trial registration number NCT01501552; Post-results. PMID:27311902

  9. A fully Bayesian before-after analysis of permeable friction course (PFC) pavement wet weather safety.

    Science.gov (United States)

    Buddhavarapu, Prasad; Smit, Andre F; Prozzi, Jorge A

    2015-07-01

    Permeable friction course (PFC), a porous hot-mix asphalt, is typically applied to improve wet weather safety on high-speed roadways in Texas. In order to warrant expensive PFC construction, a statistical evaluation of its safety benefits is essential. Generally, the literature on the effectiveness of porous mixes in reducing wet-weather crashes is limited and often inconclusive. In this study, the safety effectiveness of PFC was evaluated using a fully Bayesian before-after safety analysis. First, two groups of road segments overlaid with PFC and non-PFC material were identified across Texas; the non-PFC or reference road segments selected were similar to their PFC counterparts in terms of site specific features. Second, a negative binomial data generating process was assumed to model the underlying distribution of crash counts of PFC and reference road segments to perform Bayesian inference on the safety effectiveness. A data-augmentation based computationally efficient algorithm was employed for a fully Bayesian estimation. The statistical analysis shows that PFC is not effective in reducing wet weather crashes. It should be noted that the findings of this study are in agreement with the existing literature, although these studies were not based on a fully Bayesian statistical analysis. Our study suggests that the safety effectiveness of PFC road surfaces, or any other safety infrastructure, largely relies on its interrelationship with the road user. The results suggest that the safety infrastructure must be properly used to reap the benefits of the substantial investments. PMID:25897515

  10. Point-of-use micronutrient fortification: lessons learned in implementing a preschool-based pilot trial in South Africa

    OpenAIRE

    Covic, Namukolo Margaret; Hanekom, Susanna Magrietha; Jerling, Johann Carl; Kruger, Herculina Salome; Kvalsvig, Jane; Mamabolo, Ramoteme Lesley; Ogunlade, Adebayo Olakunle; Smuts, Cornelius Mattheus

    2011-01-01

    This current pilot trial assessed the feasibility of implementing a point-of-use (PoU) micronutrient fortification in preschool settings. Preschool children (n = 151) aged 36–79 months were randomized into intervention (n = 76) and control (n = 75) groups, both receiving breakfast maize-porridge with added micronutrient or placebo powder for 52 school days. Process evaluation and early childhood development indicators were used to assess trial feasibility. Process evaluation results showed th...

  11. Impact of picture archiving communication systems on rates of duplicate imaging: a before-after study

    Directory of Open Access Journals (Sweden)

    Yun Lingsong

    2008-11-01

    Full Text Available Abstract Background Electronic health information systems, such as picture archiving communication systems (PACS, are commonly believed to reduce the need for duplicate testing. However, empirical data to support this belief are not available. Methods Before-after study using administrative claims data from the Ontario Health Insurance Plan to determine whether the introduction of PACS at 10 hospitals in the Thames Valley region of southwestern Ontario, Canada between June 2004 and December 2005 reduced the frequency of duplicate imaging examinations. The imaging modalities studied were: chest and abdominal X-ray; computed tomography of the abdomen/pelvis, head, and chest. The frequency of duplicate testing was examined at 3 different time frames: 7 days, 30 days, and 60 days after a given index test. Results Overall frequencies of duplicate imaging were: 2.7% within 7 days of an index imaging test, 6.7% within 30 days, and 9.8% within 60 days. Comparing the 12 months before and 12 months after PACS, absolute reductions in the frequency of duplicate X-rays using 7-day, 30-day, and 60-day time frames were: 0.2% (P = 0.01, 0.6% (P increases in the frequency of duplicate CT scans after PACS of 0.0% (P = 0.92, 0.5% (P = 0.01, and 0.5% (P = 0.01, respectively. Conclusion The frequency of duplicate imaging is relatively low and we did not find large reductions in duplicate imaging after the introduction of PACS. Independent evaluation of electronic medical systems should be conducted to confirm widely held beliefs of their potential benefits.

  12. Implementing guidelines in nursing homes

    DEFF Research Database (Denmark)

    Diehl, Heinz; Graverholt, Birgitte; Espehaug, Birgitte;

    2016-01-01

    BACKGROUND: Research on guideline implementation strategies has mostly been conducted in settings which differ significantly from a nursing home setting and its transferability to the nursing home setting is therefore limited. The objective of this study was to systematically review the effects...... of interventions to improve the implementation of guidelines in nursing homes. METHODS: A systematic literature search was conducted in the Cochrane Library, CINAHL, Embase, MEDLINE, DARE, HTA, CENTRAL, SveMed + and ISI Web of Science from their inception until August 2015. Reference screening and a citation...... search were performed. Studies were eligible if they evaluated any type of guideline implementation strategy in a nursing home setting. Eligible study designs were systematic reviews, randomised controlled trials, non-randomised controlled trials, controlled before-after studies and interrupted...

  13. Improving allied health professionals’ research implementation behaviours for children with cerebral palsy: protocol for a before-after study

    OpenAIRE

    Imms, Christine; Novak, Iona; Kerr, Claire; Shields, Nora; Randall, Melinda; Harvey, Adrienne; Graham, H Kerr; Reddihough, Dinah

    2015-01-01

    Background Cerebral palsy is a permanent disorder of posture and movement caused by disturbances in the developing brain. It affects approximately 1 in every 500 children in developed countries and is the most common form of childhood physical disability. People with cerebral palsy may also have problems with speech, vision and hearing, intellectual difficulties and epilepsy. Health and therapy services are frequently required throughout life, and this care should be effective and evidence in...

  14. How implementation of systems biology into clinical trials accelerates understanding of diseases

    Directory of Open Access Journals (Sweden)

    BibianaBielekova

    2014-06-01

    Full Text Available Systems biology comprises a series of concepts and approaches that have been used successfully both to delineate novel biological mechanisms and to drive translational advances. The goal of systems biology is to re-integrate putatively critical elements extracted from multi-modality datasets in order to understand how interactions among multiple components form functional networks at the organism/patient-level, and how dysfunction of these networks underlies a particular disease. Due to the genetic and environmental diversity of human subjects, identification of critical elements related to a particular disease process from cross-sectional studies requires prohibitively large cohorts. Alternatively, implementation of systems biology principles to interventional clinical trials represents a unique opportunity to gain predictive understanding of complex diseases in comparatively small cohorts of patients. This paper reviews systems biology principles applicable to translational research, focusing on lessons from systems approaches to inflammation applied to multiple sclerosis (MS. We suggest that employing systems biology methods in the design and execution of biomarker-supported, proof-of-principle clinical trials provides a singular opportunity to merge therapeutic development with a basic understanding of disease processes. The ultimate goal is to develop predictive computational models of the disease, which will revolutionize diagnostic process and provide mechanistic understanding necessary for personalized therapeutic approaches. Added, biologically-meaningful information can be derived from diagnostic tests, if they are interpreted in functional relationships, rather than as independent measurements. Such systems-biology based diagnostics will transform disease taxonomies from phenotypical to molecular and will allow physicians to select optimal therapeutic regimens for individual patients.

  15. 76 FR 18226 - Guidance for Industry on Postmarketing Studies and Clinical Trials-Implementation of Section 505...

    Science.gov (United States)

    2011-04-01

    ... Federal Register of July 15, 2009 (74 FR 34358), FDA announced the availability of a draft guidance for... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Postmarketing Studies and Clinical Trials--Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act;...

  16. Randomized Trial of MST and ARC in a Two-Level Evidence-Based Treatment Implementation Strategy

    Science.gov (United States)

    Glisson, Charles; Schoenwald, Sonja K.; Hemmelgarn, Anthony; Green, Philip; Dukes, Denzel; Armstrong, Kevin S.; Chapman, Jason E.

    2010-01-01

    Objective: A randomized trial assessed the effectiveness of a 2-level strategy for implementing evidence-based mental health treatments for delinquent youth. Method: A 2 x 2 design encompassing 14 rural Appalachian counties included 2 factors: (a) the random assignment of delinquent youth within each county to a multisystemic therapy (MST) program…

  17. Treating Child Disruptive Behavior in High-Risk Families: A Comparative Effectiveness Trial from a Community-Based Implementation

    NARCIS (Netherlands)

    Abrahamse, Mariëlle E.; Junger, Marianne; Wouwe, van Mirjam A.M.M.; Boer, Frits; Lindauer, Ramon J.L.

    2015-01-01

    Parent management training programs have proven the most effective way to treat child behavior problems. This study reports on an effectiveness trial of a community-based implementation of Parent–Child Interaction Therapy (PCIT) in comparison with the Dutch-developed Family Creative Therapy (FCT). F

  18. Reconciling research and implementation in micro health insurance experiments in India: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Doyle Conor

    2011-10-01

    Full Text Available Abstract Background Microinsurance or Community-Based Health Insurance is a promising healthcare financing mechanism, which is increasingly applied to aid rural poor persons in low-income countries. Robust empirical evidence on the causal relations between Community-Based Health Insurance and healthcare utilisation, financial protection and other areas is scarce and necessary. This paper contains a discussion of the research design of three Cluster Randomised Controlled Trials in India to measure the impact of Community-Based Health Insurance on several outcomes. Methods/Design Each trial sets up a Community-Based Health Insurance scheme among a group of micro-finance affiliate families. Villages are grouped into clusters which are congruous with pre-existing social groupings. These clusters are randomly assigned to one of three waves of implementation, ensuring the entire population is offered Community-Based Health Insurance by the end of the experiment. Each wave of treatment is preceded by a round of mixed methods evaluation, with quantitative, qualitative and spatial evidence on impact collected. Improving upon practices in published Cluster Randomised Controlled Trial literature, we detail how research design decisions have ensured that both the households offered insurance and the implementers of the Community-Based Health Insurance scheme operate in an environment replicating a non-experimental implementation. Discussion When a Cluster Randomised Controlled Trial involves randomizing within a community, generating adequate and valid conclusions requires that the research design must be made congruous with social structures within the target population, to ensure that such trials are conducted in an implementing environment which is a suitable analogue to that of a non-experimental implementing environment.

  19. Evaluating the Accuracy of Results for Teacher Implemented Trial-Based Functional Analyses.

    Science.gov (United States)

    Rispoli, Mandy; Ninci, Jennifer; Burke, Mack D; Zaini, Samar; Hatton, Heather; Sanchez, Lisa

    2015-09-01

    Trial-based functional analysis (TBFA) allows for the systematic and experimental assessment of challenging behavior in applied settings. The purposes of this study were to evaluate a professional development package focused on training three Head Start teachers to conduct TBFAs with fidelity during ongoing classroom routines. To assess the accuracy of the TBFA results, the effects of a function-based intervention derived from the TBFA were compared with the effects of a non-function-based intervention. Data were collected on child challenging behavior and appropriate communication. An A-B-A-C-D design was utilized in which A represented baseline, and B and C consisted of either function-based or non-function-based interventions counterbalanced across participants, and D represented teacher implementation of the most effective intervention. Results showed that the function-based intervention produced greater decreases in challenging behavior and greater increases in appropriate communication than the non-function-based intervention for all three children. PMID:26069219

  20. "Did the trial kill the intervention?" experiences from the development, implementation and evaluation of a complex intervention

    Directory of Open Access Journals (Sweden)

    Cox Karen

    2011-03-01

    Full Text Available Abstract Background The development, implementation and evaluation of any new health intervention is complex. This paper uses experiences from the design, implementation and evaluation of a rehabilitation programme to shed light on, and prompt discussion around, some of the complexities involved in such an undertaking. Methods Semi-structured interviews were conducted with 15 trial participants and five members of staff at the conclusion of a trial evaluating a rehabilitation programme aimed at promoting recovery after stem cell transplantation. Results This study identified a number of challenges relating to the development and evaluation of complex interventions. The difficulty of providing a standardised intervention that was acceptable to patients was highlighted in the participant interviews. Trial participants and some members of staff found the concept of equipoise and randomisation challenging and there was discord between the psychosocial nature of the intervention and the predominant bio-medical culture in which the research took place. Conclusions A lack of scientific evidence as to the efficacy of an intervention does not preclude staff and patients holding strong views about the benefits of an intervention. The evaluation of complex interventions should, where possible, facilitate not restrict that complexity. Within the local environment where the trial is conducted, acquiescence from those in positions of authority is insufficient; commitment to the trial is required.

  1. Issues Related to Implementing a Smoking Cessation Clinical Trial for Cancer Patients1

    OpenAIRE

    Martinez, Elisa; Tatum, Kristina L.; Weber, Dorothy M.; Kuzla, Natalie; Pendley, Anna B.S.; Campbell, Kirsten; Ridge, John A; Langer, Corey; Miyamoto, Curtis; Schnoll, Robert A.

    2008-01-01

    Given high rates of smoking among cancer patients, smoking cessation treatment is crucial, yet limited data exist to guide integration of such trials into the oncologic context. To determine the feasibility of conducting smoking cessation clinical trials with cancer patients, screening and baseline data from a large randomized placebo-controlled pharmacotherapy trial were analyzed. Descriptive statistics and regression analyses were used to compare enrollees to decliners, describe program enr...

  2. Implementation of physical coordination training and cognitive behavioural training interventions at cleaning workplaces - secondary analyses of a randomised controlled trial

    DEFF Research Database (Denmark)

    Jørgensen, Marie B; Faber, Anne; Jespersen, Tobias;

    2012-01-01

    intervention effects, more research on implementation is needed. Trial registration: ISRCTN96241850. Practitioner summary: Both physical coordination training and cognitive behavioural training are potential effective workplace interventions among low educated job groups with high physical work demands......This study evaluates the implementation of physical coordination training (PCT) and cognitive behavioural training (CBTr) interventions in a randomised controlled trial at nine cleaners' workplaces. Female cleaners (n = 294) were randomised into a PCT, a CBTr or a reference (REF) group. Both 12......-week interventions were performed in groups guided by an instructor. Records were kept on intervention dose (adherence) unanticipated events at the work place (context) and quality of intervention delivery (fidelity). Participant adherence was 37% in the PCT and 49% in the CBTr interventions. Optimal...

  3. Protocol for a statewide randomized controlled trial to compare three training models for implementing an evidence-based treatment

    OpenAIRE

    Herschell, Amy D.; Kolko, David J.; Scudder, Ashley T.; Taber-Thomas, Sarah; Schaffner, Kristen F.; Hiegel, Shelley A.; Iyengar, Satish; Chaffin, Mark; Mrozowski, Stanley

    2015-01-01

    Background Evidence-based treatments (EBTs) are available for treating childhood behavioral health challenges. Despite EBTs’ potential to help children and families, they have primarily remained in university settings. Little empirical evidence exists regarding how specific, commonly used training and quality control models are effective in changing practice, achieving full implementation, and supporting positive client outcomes. Methods/design This study (NIMH RO1 MH095750; ClinicalTrials.go...

  4. Implementing a Complex Intervention to Support Personal Recovery: A Qualitative Study Nested within a Cluster Randomised Controlled Trial

    OpenAIRE

    Leamy, Mary; Clarke, Eleanor; Le Boutillier, Clair; Bird, Victoria; Janosik, Monika; Sabas, Kai; Riley, Genevieve; Williams, Julie; Slade, Mike

    2014-01-01

    Objective To investigate staff and trainer perspectives on the barriers and facilitators to implementing a complex intervention to help staff support the recovery of service users with a primary diagnosis of psychosis in community mental health teams. Design Process evaluation nested within a cluster randomised controlled trial (RCT). Participants 28 interviews with mental health care staff, 3 interviews with trainers, 4 focus groups with intervention teams and 28 written trainer reports. Set...

  5. An Evaluation of an E-learning Training Course to Teach Instructors to Implement Discrete Trial Teaching

    OpenAIRE

    Pollard, Joy S

    2012-01-01

    Children diagnosed with autism spectrum disorder often require early intensive behavioral interventions (EIBI) to learn new skills and decrease maladaptive behaviors. Discrete trial instruction (DTI) is a strategy behavior analysts often incorporate in EIBI programs. Researchers have demonstrated that DTI is very effective, but it requires intensive training for teachers to implement the strategy with high fidelity. Therefore, researchers have recently begun to investigate more time-efficient...

  6. Implementing nurse-initiated and managed antiretroviral treatment (NIMART in South Africa: a qualitative process evaluation of the STRETCH trial

    Directory of Open Access Journals (Sweden)

    Georgeu Daniella

    2012-07-01

    Full Text Available Abstract Background Task-shifting is promoted widely as a mechanism for expanding antiretroviral treatment (ART access. However, the evidence for nurse-initiated and managed ART (NIMART in Africa is limited, and little is known about the key barriers and enablers to implementing NIMART programmes on a large scale. The STRETCH (Streamlining Tasks and Roles to Expand Treatment and Care for HIV programme was a complex educational and organisational intervention implemented in the Free State Province of South Africa to enable nurses providing primary HIV/AIDS care to expand their roles and include aspects of care and treatment usually provided by physicians. STRETCH used a phased implementation approach and ART treatment guidelines tailored specifically to nurses. The effects of STRETCH on pre-ART mortality, ART provision, and the quality of HIV/ART care were evaluated through a randomised controlled trial. This study was conducted alongside the trial to develop a contextualised understanding of factors affecting the implementation of the programme. Methods This study was a qualitative process evaluation using in-depth interviews and focus group discussions with patients, health workers, health managers, and other key informants as well as observation in clinics. Research questions focused on perceptions of STRETCH, changes in health provider roles, attitudes and patient relationships, and impact of the implementation context on trial outcomes. Data were analysed collaboratively by the research team using thematic analysis. Results NIMART appears to be highly acceptable among nurses, patients, and physicians. Managers and nurses expressed confidence in their ability to deliver ART successfully. This confidence developed slowly and unevenly, through a phased and well-supported approach that guided nurses through training, re-prescription, and initiation. The research also shows that NIMART changes the working and referral relationships between health

  7. Design and implementation of the Resuscitation Outcomes Consortium Pragmatic Airway Resuscitation Trial (PART).

    Science.gov (United States)

    Wang, Henry E; Prince, David K; Stephens, Shannon W; Herren, Heather; Daya, Mohamud; Richmond, Neal; Carlson, Jestin; Warden, Craig; Colella, M Riccardo; Brienza, Ashley; Aufderheide, Tom P; Idris, Ahamed H; Schmicker, Robert; May, Susanne; Nichol, Graham

    2016-04-01

    Airway management is an important component of resuscitation from out-of-hospital cardiac arrest (OHCA). The optimal approach to advanced airway management is unknown. The Pragmatic Airway Resuscitation Trial (PART) will compare the effectiveness of endotracheal intubation (ETI) and Laryngeal Tube (LT) insertion upon 72-h survival in adult OHCA. Encompassing United States Emergency Medical Services agencies affiliated with the Resuscitation Outcomes Consortium (ROC), PART will use a cluster-crossover randomized design. Participating subjects will include adult, non-traumatic OHCA requiring bag-valve-mask ventilation. Trial interventions will include (1) initial airway management with ETI and (2) initial airway management with LT. The primary and secondary trial outcomes are 72-h survival and return of spontaneous circulation. Additional clinical outcomes will include airway management process and adverse events. The trial will enroll a total of 3000 subjects. Results of PART may guide the selection of advanced airway management strategies in OHCA. PMID:26851059

  8. The implementation of the serial trial intervention for pain and challenging behaviour in advanced dementia patients (STA OP!: a clustered randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Francke Anneke L

    2011-03-01

    Full Text Available Abstract Background Pain (physical discomfort and challenging behaviour are highly prevalent in nursing home residents with dementia: at any given time 45-80% of nursing home residents are in pain and up to 80% have challenging behaviour. In the USA Christine Kovach developed the serial trial intervention (STI and established that this protocol leads to less discomfort and fewer behavioural symptoms in moderate to severe dementia patients. The present study will provide insight into the effects of implementation of the Dutch version of the STI-protocol (STA OP! in comparison with a control intervention, not only on behavioural symptoms, but also on pain, depression, and quality of life. This article outlines the study protocol. Methods/Design The study is a cluster randomized controlled trial in 168 older people (aged >65 years with mild or moderate dementia living in nursing homes. The clusters, Dutch nursing homes, are randomly assigned to either the intervention condition (training and implementation of the STA OP!-protocol or the control condition (general training focusing on challenging behaviour and pain, but without the step-wise approach. Measurements take place at baseline, after 3 months (end of the STA OP! training period and after 6 months. Primary outcome measures are symptoms of challenging behaviour (measured with the Cohen-Mansfield Agitation Inventory (CMAI and the Neuropsychiatric Inventory-Nursing Home version (NPI-NH, and pain (measure with the Dutch version of the Pain Assessment Checklist for Seniors (PACSLAC-D and the Minimum Data Set of the Resident Assessment Instrument (MDS-RAI pain scale. Secondary outcome measures include symptoms of depression (Cornell and MDS-RAI depression scale, Quality of Live (Qualidem, changes in prescriptions of analgesics and psychotropic drugs, and the use of non-pharmacological comfort interventions (e.g. snoezelen, reminiscence therapy. Discussion The transfer from the American design to

  9. Implementation of ring trials to establish methods for detecting irradiated foods according art. 35 LMBG

    International Nuclear Information System (INIS)

    The use of methods to identify irradiated products in food monitoring requires detection to be reliable and reproducible. These criteria can be met by routine method established according to art. 35 LMBG (food irradiation act). In 1989, two methods to detect irradiated spices and dried vegetable by means of thermoluminescence and chemiluminescence were included in the compilation of routine methods of art. 35 LMBG. In 1992, BGA (Federal Health Agency) conducted three major ring trials to establish additional methods. Most participants in there ring trials were representatives of food examination authorities using ESR spectrocopy, thermoluminescence and the GC/MS method. (orig./UHE)

  10. IMPLEmenting a clinical practice guideline for acute low back pain evidence-based manageMENT in general practice (IMPLEMENT: Cluster randomised controlled trial study protocol

    Directory of Open Access Journals (Sweden)

    Francis Jill

    2008-02-01

    Full Text Available Abstract Background Evidence generated from reliable research is not frequently implemented into clinical practice. Evidence-based clinical practice guidelines are a potential vehicle to achieve this. A recent systematic review of implementation strategies of guideline dissemination concluded that there was a lack of evidence regarding effective strategies to promote the uptake of guidelines. Recommendations from this review, and other studies, have suggested the use of interventions that are theoretically based because these may be more effective than those that are not. An evidence-based clinical practice guideline for the management of acute low back pain was recently developed in Australia. This provides an opportunity to develop and test a theory-based implementation intervention for a condition which is common, has a high burden, and for which there is an evidence-practice gap in the primary care setting. Aim This study aims to test the effectiveness of a theory-based intervention for implementing a clinical practice guideline for acute low back pain in general practice in Victoria, Australia. Specifically, our primary objectives are to establish if the intervention is effective in reducing the percentage of patients who are referred for a plain x-ray, and improving mean level of disability for patients three months post-consultation. Methods/Design This study protocol describes the details of a cluster randomised controlled trial. Ninety-two general practices (clusters, which include at least one consenting general practitioner, will be randomised to an intervention or control arm using restricted randomisation. Patients aged 18 years or older who visit a participating practitioner for acute non-specific low back pain of less than three months duration will be eligible for inclusion. An average of twenty-five patients per general practice will be recruited, providing a total of 2,300 patient participants. General practitioners in the

  11. HIV Rapid Testing in Substance Abuse Treatment: Implementation Following a Clinical Trial

    Science.gov (United States)

    Haynes, L. F.; Korte, J. E.; Holmes, B. E.; Gooden, L.; Matheson, T.; Feaster, D. J.; Leff, J. A.; Wilson, L.; Metsch, L. R.; Schackman, B. R.

    2011-01-01

    The Substance Abuse Mental Health Services Administration has promoted HIV testing and counseling as an evidence-based practice. Nevertheless, adoption of HIV testing in substance abuse treatment programs has been slow. This article describes the experience of a substance abuse treatment agency where, following participation in a clinical trial,…

  12. A randomised controlled trial of an intervention to increase the implementation of a healthy canteen policy in Australian primary schools: study protocol

    OpenAIRE

    Wolfenden, Luke; Nathan, Nicole; Williams, Christopher M.; Delaney, Tessa; Reilly, Kathryn L; Freund, Megan; Gillham, Karen; Sutherland, Rachel; Bell, Andrew C; Campbell, Libby; Yoong, Serene; Wyse, Rebecca; Janssen, Lisa M; Preece, Sarah; Asmar, Melanie

    2014-01-01

    Background The implementation of healthy school canteen policies has been recommended as a strategy to help prevent unhealthy eating and excessive weight gain. Internationally, research suggests that schools often fail to implement practices consistent with healthy school canteen policies. Without a population wide implementation, the potential benefits of these policies will not be realised. The aim of this trial is to assess the effectiveness of an implementation intervention in increasing ...

  13. Abortion Before & After Roe

    Science.gov (United States)

    Joyce, Ted; Tan, Ruoding; Zhang, Yuxiu

    2013-01-01

    We use unique data on abortions performed in New York State from 1971–1975 to demonstrate that women travelled hundreds of miles for a legal abortion before Roe. A100- mile increase in distance for women who live approximately 183 miles from New York was associated with a decline in abortion rates of 12.2 percent whereas the same change for women who lived 830 miles from New York lowered abortion rates by 3.3 percent. The abortion rates of nonwhites were more sensitive to distance than those of whites. We found a positive and robust association between distance to the nearest abortion provider and teen birth rates but less consistent estimates for other ages. Our results suggest that even if some states lost all abortion providers due to legislative policies, the impact on population measures of birth and abortion rates would be small as most women would travel to states with abortion services. PMID:23811233

  14. Examining Contextual Influences on Classroom-Based Implementation of Positive Behavior Support Strategies: Findings from a Randomized Controlled Effectiveness Trial.

    Science.gov (United States)

    Pas, Elise T; Waasdorp, Tracy E; Bradshaw, Catherine P

    2015-11-01

    Although it is widely recognized that variation in implementation fidelity influences the impact of preventive interventions, little is known about how specific contextual factors may affect the implementation of social and behavioral interventions in classrooms. Theoretical research highlights the importance of multiple contextual influences on implementation, including factors at the classroom and school level (Domitrovich et al., Advances in School Mental Health Promotion, 1, 6-28, 2008). The current study used multi-level modeling to empirically examine the influence of teacher, classroom, and school characteristics on the implementation of classroom-based positive behavior support strategies over the course of 4 years. Data were collected in the context of a 37-school randomized controlled trial examining the effectiveness of school-wide Positive Behavioral Interventions and Supports. Multi-level results identified several school-level contextual factors (e.g., school size, behavioral disruptions) and teacher-level factors (perceptions of school organizational health and grade level taught) associated with variability in the implementation of classroom-based positive behavior supports. Implications for prevention research and practice are discussed. PMID:24793222

  15. Training Novice Instructors to Implement Errorless Discrete-Trial Teaching: A Sequential Analysis

    OpenAIRE

    Severtson, Jamie M.; Carr, James E

    2012-01-01

    Discrete trial teaching (DTT) is a common instructional method incorporated into intensive behavioral intervention programs for children diagnosed with autism. Errorless learning strategies are frequently recommended during DTT because they often result in more efficient and effective instruction. The purpose of the present study was to conduct a sequential analysis of the efficacy of three methods for teaching errorless DTT procedures to novice instructors: (a) a self-instruction manual, (b)...

  16. Advancing donor management research: design and implementation of a large, randomized, placebo-controlled trial

    OpenAIRE

    Ware, Lorraine B; Koyama, Tatsuki; Billheimer, Dean; Landeck, Megan; Johnson, Elizabeth; Brady, Sandra; Bernard, Gordon R.; Matthay, Michael A

    2011-01-01

    Background Given the persistent shortage of organs for transplantation, new donor management strategies to improve both organ utilization and quality of procured organs are needed. Current management protocols for the care of the deceased donor before organ procurement are based on physiological rationale, experiential reasoning, and retrospective studies without rigorous testing. Although many factors contribute to the lack of controlled clinical trials in donor management, a major factor is...

  17. Implications of medical devices quality assurance for implementation of experimental clinical trials

    International Nuclear Information System (INIS)

    The basis for all controlled clinical trials is the comparison of a new treatment with the standard treatment. The effect of the experimental procedure on the natural history of the disease is the result observed; but the interpretation of the results in cancer clinical experimentation is often difficult due to the variability of the clinical course of individual cancers in a given category. It has been possible to categorize cancers by means of prognostic factors and evaluate the results of therapy within each prognostic category, but there is still much variability within each category. The only way to determine whether or not a new treatment can be used for a particular form of cancer is to try it out on patients in clinical trials. The cooperative practice was originally induced by the realistic need for large sample sizes, but the variability in the interpretation of the results increased due to difficulties in comparing data. This is one of the main problems in cancer literature. These problems originate from inconsistent or incomplete reporting of the patient population under study, the treatment administered, the statistical methods employed to assess treatment efficacy and from differences in the definition of response criteria. This paper tries to outline the impact on the results evaluation of the lack of standardized prognostic factors and standardized therapeutic modalities in the selection and treatment of patients included in clinical trials

  18. Implementation of an Ebola virus disease vaccine clinical trial during the Ebola epidemic in Liberia: Design, procedures, and challenges.

    Science.gov (United States)

    Kennedy, Stephen B; Neaton, James D; Lane, H Clifford; Kieh, Mark W S; Massaquoi, Moses B F; Touchette, Nancy A; Nason, Martha C; Follmann, Dean A; Boley, Fatorma K; Johnson, Melvin P; Larson, Gregg; Kateh, Francis N; Nyenswah, Tolbert G

    2016-02-01

    The index case of the Ebola virus disease epidemic in West Africa is believed to have originated in Guinea. By June 2014, Guinea, Liberia, and Sierra Leone were in the midst of a full-blown and complex global health emergency. The devastating effects of this Ebola epidemic in West Africa put the global health response in acute focus for urgent international interventions. Accordingly, in October 2014, a World Health Organization high-level meeting endorsed the concept of a phase 2/3 clinical trial in Liberia to study Ebola vaccines. As a follow-up to the global response, in November 2014, the Government of Liberia and the US Government signed an agreement to form a research partnership to investigate Ebola and to assess intervention strategies for treating, controlling, and preventing the disease in Liberia. This agreement led to the establishment of the Joint Liberia-US Partnership for Research on Ebola Virus in Liberia as the beginning of a long-term collaborative partnership in clinical research between the two countries. In this article, we discuss the methodology and related challenges associated with the implementation of the Ebola vaccines clinical trial, based on a double-blinded randomized controlled trial, in Liberia. PMID:26768572

  19. Lessons learnt from implementing an empirically informed recruitment approach for FEM-PrEP, a large HIV prevention clinical trial

    Directory of Open Access Journals (Sweden)

    Parker C

    2014-12-01

    Full Text Available Caleb Parker,1 Amy Corneli,1 Kawango Agot,2 Jacob Odhiambo,2 Jesse Asewe,2 Khatija Ahmed,3 Joseph Skhosana,3 Malebo Ratlhagana,3 Michele Lanham,1 Christina Wong,1 Jennifer Deese,1 Rachel Manongi,4 Lut Van Damme,1On behalf of the FEM-PrEP recruitment group 1FHI 360, Global Health, Population and Nutrition, Durham, NC, USA; 2Impact Research and Development Organization, Kisumu, Kenya; 3Setshaba Research Centre, Soshanguve, Pretoria, South Africa; 4Kilimanjaro Christian Medical Centre, Moshi, Tanzania Abstract: We implemented an empirically informed, geographically based recruitment approach for FEM-PrEP, a human immunodeficiency virus (HIV prevention clinical trial of daily oral emtricitabine (FTC and tenofovir disoproxil fumarate (TDF for HIV prevention. During the formative research phase, we conducted a modification of the Priorities for Local AIDS Control Efforts (PLACE method and used those data and staff experiences to identify and prioritize for recruitment geographic areas where HIV incidence might be high. During the clinical trial, we implemented a routinely monitored and flexible recruitment plan in the geographical areas identified in the formative research. We describe three lessons learnt from implementing this approach: 1 the PLACE data were critical in identifying places presumed to be high risk; 2 staff experiences, in combination with PLACE data, were needed to inform a practical recruitment strategy; and 3 recruiting in establishments in priority areas identified by the PLACE data led to screening many HIV-positive women at the Bondo site (Kenya, placing additional burden on clinic staff. These lessons learnt highlight the critical importance of having a flexible and monitored recruitment strategy. Although we successfully recruited a study population at higher risk for HIV, FEM-PrEP was unable to determine the effectiveness of FTC/TDF for HIV prevention, due to low adherence to the study product among participants. We must

  20. Building a Community-Academic Partnership: Implementing a Community-Based Trial of Telephone Cognitive Behavioral Therapy for Rural Latinos

    Directory of Open Access Journals (Sweden)

    Eugene Aisenberg

    2012-01-01

    Full Text Available Concerns about the appropriate use of EBP with ethnic minority clients and the ability of community agencies to implement and sustain EBP persist and emphasize the need for community-academic research partnerships that can be used to develop, adapt, and test culturally responsive EBP in community settings. In this paper, we describe the processes of developing a community-academic partnership that implemented and pilot tested an evidence-based telephone cognitive behavioral therapy program. Originally demonstrated to be effective for urban, middle-income, English-speaking primary care patients with major depression, the program was adapted and pilot tested for use with rural, uninsured, low-income, Latino (primarily Spanish-speaking primary care patients with major depressive disorder in a primary care site in a community health center in rural Eastern Washington. The values of community-based participatory research and community-partnered participatory research informed each phase of this randomized clinical trial and the development of a community-academic partnership. Information regarding this partnership may guide future community practice, research, implementation, and workforce development efforts to address mental health disparities by implementing culturally tailored EBP in underserved communities.

  1. A cluster randomized trial of routine HIV-1 viral load monitoring in Zambia: study design, implementation, and baseline cohort characteristics.

    Directory of Open Access Journals (Sweden)

    John R Koethe

    Full Text Available BACKGROUND: The benefit of routine HIV-1 viral load (VL monitoring of patients on antiretroviral therapy (ART in resource-constrained settings is uncertain because of the high costs associated with the test and the limited treatment options. We designed a cluster randomized controlled trial to compare the use of routine VL testing at ART-initiation and at 3, 6, 12, and 18 months, versus our local standard of care (which uses immunological and clinical criteria to diagnose treatment failure, with discretionary VL testing when the two do not agree. METHODOLOGY: Dedicated study personnel were integrated into public-sector ART clinics. We collected participant information in a dedicated research database. Twelve ART clinics in Lusaka, Zambia constituted the units of randomization. Study clinics were stratified into pairs according to matching criteria (historical mortality rate, size, and duration of operation to limit the effect of clustering, and independently randomized to the intervention and control arms. The study was powered to detect a 36% reduction in mortality at 18 months. PRINCIPAL FINDINGS: From December 2006 to May 2008, we completed enrollment of 1973 participants. Measured baseline characteristics did not differ significantly between the study arms. Enrollment was staggered by clinic pair and truncated at two matched sites. CONCLUSIONS: A large clinical trial of routing VL monitoring was successfully implemented in a dynamic and rapidly growing national ART program. Close collaboration with local health authorities and adequate reserve staff were critical to success. Randomized controlled trials such as this will likely prove valuable in determining long-term outcomes in resource-constrained settings. TRIAL REGISTRATION: Clinicaltrials.gov NCT00929604.

  2. NAOMI: The trials and tribulations of implementing a heroin assisted treatment study in North America

    Directory of Open Access Journals (Sweden)

    Laliberté Nancy

    2009-01-01

    Full Text Available Abstract Background Opioid addiction is a chronic, relapsing disease and remains a major public health challenge. Despite important expansions of access to conventional treatments, there are still significant proportions of affected individuals who remain outside the reach of the current treatment system and who contribute disproportionately to health care and criminal justice costs as well as to public disorder associated with drug addiction. The NAOMI study is a Phase III randomized clinical trial comparing injectable heroin maintenance to oral methadone. The study has ethics board approval at its Montréal and Vancouver sites, as well as from the University of Toronto, the New York Academy of Medicine and Johns Hopkins University. The main objective of the NAOMI Study is to determine whether the closely supervised provision of injectable, pharmaceutical-grade opioid agonist is more effective than methadone alone in recruiting, retaining, and benefiting chronic, opioid-dependent, injection drug users who are resistant to current standard treatment options. Methods The case study submitted chronicles the challenges of getting a heroin assisted treatment trial up and running in North America. It describes: a brief background on opioid addiction; current standard therapies for opioid addiction; why there is/was a need for a heroin assisted treatment trial; a description of heroin assisted treatment; the beginnings of creating the NAOMI study in North America; what is the NAOMI study; the science and politics of the NAOMI study; getting NAOMI started in Canada; various requirements and restrictions in getting the study up and running; recruitment into the study; working with the media; a status report on the study; and a brief conclusion from the authors' perspectives. Results and conclusion As this is a case study, there are no specific results or main findings listed. The case study focuses on: the background of the study; what it took to get

  3. Quality assessment of diagnostic before-after studies: development of methodology in the context of a systematic review

    Directory of Open Access Journals (Sweden)

    Davenport Clare F

    2009-01-01

    Full Text Available Abstract Background Quality assessment tools for primary studies of test accuracy are relatively well developed, although only one is validated (QUADAS, but very little work has been done to develop tools to quality-assess studies evaluating the impact of diagnostic testing on management of patients (diagnostic or therapeutic yield. The recent draft NICE Guide to the Methods of Technology Appraisal (2007 suggests QUADAS "as a useful starting point for appraising studies that evaluate the sensitivity and specificity of a test" but does not mention how to quality assess diagnostic or therapeutic yield studies, in particular diagnostic before-after studies. In the context of undertaking a rapid systematic review of structural neuroimaging in psychosis for NICE, we describe the modifications that we made to QUADAS, our experience of this in practice and in relation to published theory on diagnostic or therapeutic yield studies. Methods The QUADAS tool was assessed for use in the review by two systematic reviewers with in-depth knowledge of the clinical area being reviewed and the types of studies being found in the searches that could answer the clinical question. Modifications were made following discussion as considered appropriate. Results Two QUADAS questions were removed altogether and. four additional questions were developed to capture additional quality issues not addressed by QUADAS. However, the developed checklist only partially helped to discern implications of the study designs on the results given. Conclusion The division between topic-specific and more generic quality items of relevance to diagnostic before-after studies is important. With more time, further work could have been done to create a better quality assessment tool, for example by incorporating some of the issues mentioned in previous work in this area. This paper is a discussion around quality assessment and is intended to offer insights into the types of issues that

  4. Implementing a guideline for the treatment of type 2 diabetics: results of a Cluster- Randomized Controlled Trial (C-RCT

    Directory of Open Access Journals (Sweden)

    Grasso Giuseppe

    2007-06-01

    Full Text Available Abstract Background In Italy many diabetics still lack adequate care in general practice. We assessed the effectiveness of different strategies for the implementation of an evidence-based guideline for the management of non-complicated type 2 diabetes among General Practitioners (GPs of Lazio region. Methods Three-arm cluster-randomised controlled trial with GPs as units of randomisation (clusters. 252 GPs were randomised either to an active strategy (training module with administration of the guideline, or to a passive dissemination (administration of the guideline only, or to usual care (control. Data on prescriptions of tests and drugs were collected by existing information systems, whereas patients' data came from GPs' databases. Process outcomes were measured at the cluster level one year after the intervention. Primary outcomes concerned the measurement of glycosilated haemoglobin and the commissioning of micro- and macrovascular complications assessment tests. In order to assess the physicians' drug prescribing behaviour secondary outcomes were also calculated. Results GPs identified 6395 uncomplicated type 2 patients with a high prevalence of cardiovascular risk factors. Data on GPs baseline performance show low proportions of glycosilated haemoglobin assessments. Results of the C-RCT analysis indicate that the active implementation strategy was ineffective relating to all primary outcomes (respectively, OR 1.06 [95% IC: 0.76–1.46]; OR 1.07 [95% IC: 0.80–1.43]; OR 1.4 [95% IC:0.91–2.16]. Similarly, passive dissemination of the guideline showed no effect. Conclusion In our region compliance of GPs with guidelines was not enhanced by a structured learning programme. Implementation through organizational measures appears to be essential to induce behavioural changes. Trial registration ISRCTN80116232

  5. Safety impacts of platform tram stops on pedestrians in mixed traffic operation: A comparison group before-after crash study.

    Science.gov (United States)

    Naznin, Farhana; Currie, Graham; Logan, David; Sarvi, Majid

    2016-01-01

    Tram stops in mixed traffic environments present a variety of safety, accessibility and transport efficiency challenges. In Melbourne, Australia the hundred year-old electric tram system is progressively being modernized to improve passenger accessibility. Platform stops, incorporating raised platforms for level entry into low floor trams, are being retro-fitted system-wide to replace older design stops. The aim of this study was to investigate the safety impacts of platform stops over older design stops (i.e. Melbourne safety zone tram stops) on pedestrians in the context of mixed traffic tram operation in Melbourne, using an advanced before-after crash analysis approach, the comparison group (CG) method. The CG method evaluates safety impacts by taking into account the general trends in safety and the unobserved factors at treatment and comparison sites that can alter the outcomes of a simple before-after analysis. The results showed that pedestrian-involved all injury crashes reduced by 43% after platform stop installation. This paper also explores a concern that the conventional CG method might underestimate safety impacts as a result of large differences in passenger stop use between treatment and comparison sites, suggesting differences in crash risk exposure. To adjust for this, a modified analysis explored crash rates (crash counts per 10,000 stop passengers) for each site. The adjusted results suggested greater reductions in pedestrian-involved crashes after platform stop installation: an 81% reduction in pedestrian-involved all injury crashes and 86% reduction in pedestrian-involved FSI crashes, both are significant at the 95% level. Overall, the results suggest that platform stops have considerable safety benefits for pedestrians. Implications for policy and areas for future research are explored. PMID:26476596

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

    Science.gov (United States)

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

    2009-01-01

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

  7. Weight-loss intervention using implementation intentions and mental imagery: a randomised control trial study protocol

    OpenAIRE

    Hattar, Anne; Hagger, Martin S.; Pal, Sebely

    2015-01-01

    Background Overweight and obesity are major health problems worldwide. This protocol describes the HEALTHI (Healthy Eating and Active LifesTyle Health Intervention) Program, a 12-week randomised-controlled weight-loss intervention that adopts two theory-based intervention techniques, mental imagery and implementation intentions, a behaviour-change technique based on planning that have been shown to be effective in promoting health-behaviour change in previous research. The effectiveness of go...

  8. Preformulated Implementation Intentions to Promote Colorectal Cancer Screening: A Cluster-Randomized Trial

    OpenAIRE

    Lo, S. H.; Good, A; Sheeran, P.; G. Baio; Rainbow, S; Vart, G.; von Wagner, C

    2013-01-01

    Objective: To evaluate an intervention based on implementation intention principles designed to increase uptake of colorectal cancer screening, and to examine differential efficacy by socioeconomic deprivation. Method: In England, adults aged between 60 and 69 years are invited for biennial fecal occult blood testing. A test kit and an information leaflet are mailed to each individual by the "Hubs" that deliver the national screening program. In the intervention group, three preformulated imp...

  9. Evaluation of a patient-initiated review system in rheumatoid arthritis: an implementation trial protocol

    Directory of Open Access Journals (Sweden)

    Paudyal Priyamvada

    2012-07-01

    Full Text Available Abstract Background Rheumatoid arthritis is a chronic inflammatory condition that affects the joints causing unpredictable episodes of pain, stiffness and disability. People with rheumatoid arthritis usually require lifelong specialist follow-up but frequently have periods when their disease can be managed through self-care or that provided by their general practitioner. Compared to the traditional clinician-driven care in rheumatoid arthritis, patient-initiated care has proven to be more beneficial in terms of reducing unnecessary medical reviews, providing greater satisfaction to patients and staffs and maintaining the patient’s physical and psychological status. We aim to evaluate the implementation of a patient-initiated review system in a routine secondary care rheumatology service in a public hospital in England, where patients get the opportunity to self-manage their disease by requesting specialist reviews at times of need instead of clinician-scheduled appointments. Methods/design Three hundred and eighty patients attending routine review at Plymouth Hospitals NHS Trust will be randomised to either enrol immediately into a patient-initiated review system (direct access group, or to be seen regularly by a clinician at the hospital (regular clinician-initiated group. Patients (or their general practitioner in the direct access group can arrange a review by calling a rheumatology nurse-led advice line that enables telephone delivered clinical advice, or where appropriate, an appointment with a rheumatologist within 10 working days. Patients in the regular clinician-initiated group will attend their planned appointments at regular intervals during the intervening period of 12 months. The primary outcome of interest is patient satisfaction; secondary outcomes include service use, waiting times and clinical measures. Semi-structured, in-depth interviews will be conducted with a subset of patients and staff with the aim of identifying

  10. Impact of computerized physician order entry (CPOE system on the outcome of critically ill adult patients: a before-after study

    Directory of Open Access Journals (Sweden)

    Al-Dorzi Hasan M

    2011-11-01

    Full Text Available Abstract Background Computerized physician order entry (CPOE systems are recommended to improve patient safety and outcomes. However, their effectiveness has been questioned. Our objective was to evaluate the impact of CPOE implementation on the outcome of critically ill patients. Methods This was an observational before-after study carried out in a 21-bed medical and surgical intensive care unit (ICU of a tertiary care center. It included all patients admitted to the ICU in the 24 months pre- and 12 months post-CPOE (Misys® implementation. Data were extracted from a prospectively collected ICU database and included: demographics, Acute Physiology and Chronic Health Evaluation (APACHE II score, admission diagnosis and comorbid conditions. Outcomes compared in different pre- and post-CPOE periods included: ICU and hospital mortality, duration of mechanical ventilation, and ICU and hospital length of stay. These outcomes were also compared in selected high risk subgroups of patients (age 12-17 years, traumatic brain injury, admission diagnosis of sepsis and admission APACHE II > 23. Multivariate analysis was used to adjust for imbalances in baseline characteristics and selected clinically relevant variables. Results There were 1638 and 898 patients admitted to the ICU in the specified pre- and post-CPOE periods, respectively (age = 52 ± 22 vs. 52 ± 21 years, p = 0.74; APACHE II = 24 ± 9 vs. 24 ± 10, p = 0.83. During these periods, there were no differences in ICU (adjusted odds ratio (aOR 0.98, 95% confidence interval [CI] 0.7-1.3 and in hospital mortality (aOR 1.00, 95% CI 0.8-1.3. CPOE implementation was associated with similar duration of mechanical ventilation and of stay in the ICU and hospital. There was no increased mortality or stay in the high risk subgroups after CPOE implementation. Conclusions The implementation of CPOE in an adult medical surgical ICU resulted in no improvement in patient outcomes in the immediate phase and up to

  11. Scaling-up from an implementation trial to state-wide coverage: results from the preliminary Melbourne Diabetes Prevention Study

    Directory of Open Access Journals (Sweden)

    Janus Edward D

    2012-08-01

    Full Text Available Abstract Background The successful Greater Green Triangle Diabetes Prevention Program (GGT DPP, a small implementation trial, has been scaled-up to the Victorian state-wide ‘Life!’ programme with over 10,000 individuals enrolled. The Melbourne Diabetes Prevention Study (MDPS is an evaluation of the translation from the GGT DPP to the Life! programme. We report results from the preliminary phase (pMDPS of this evaluation. Methods The pMDPS is a randomised controlled trial with 92 individuals aged 50 to 75 at high risk of developing type 2 diabetes randomised to Life! or usual care. Intervention consisted of six structured 90-minute group sessions: five fortnightly sessions and the final session at 8 months. Participants underwent anthropometric and laboratory tests at baseline and 12 months, and provided self-reported psychosocial, dietary, and physical activity measures. Intervention group participants additionally underwent these tests at 3 months. Paired t tests were used to analyse within-group changes over time. Chi-square tests were used to analyse differences between groups in goals met at 12 months. Differences between groups for changes over time were tested with generalised estimating equations and analysis of covariance. Results Intervention participants significantly improved at 12 months in mean body mass index (−0.98 kg/m2, standard error (SE = 0.26, weight (−2.65 kg, SE = 0.72, waist circumference (−7.45 cm, SE = 1.15, and systolic blood pressure (−3.18 mmHg, SE = 1.26, increased high-density lipoprotein-cholesterol (0.07 mmol/l, SE = 0.03, reduced energy from total (−2.00%, SE = 0.78 and saturated fat (−1.54%, SE = 0.41, and increased fibre intake (1.98 g/1,000 kcal energy, SE = 0.47. In controls, oral glucose at 2 hours deteriorated (0.59 mmol/l, SE = 0.27. Only waist circumference reduced significantly (−4.02 cm, SE = 0.95. Intervention participants significantly

  12. Ecosystem scale declines in elk recruitment and population growth with wolf colonization: a before-after-control-impact approach.

    Directory of Open Access Journals (Sweden)

    David Christianson

    Full Text Available The reintroduction of wolves (Canis lupus to Yellowstone provided the unusual opportunity for a quasi-experimental test of the effects of wolf predation on their primary prey (elk--Cervus elaphus in a system where top-down, bottom-up, and abiotic forces on prey population dynamics were closely and consistently monitored before and after reintroduction. Here, we examined data from 33 years for 12 elk population segments spread across southwestern Montana and northwestern Wyoming in a large scale before-after-control-impact analysis of the effects of wolves on elk recruitment and population dynamics. Recruitment, as measured by the midwinter juvenile∶female ratio, was a strong determinant of elk dynamics, and declined by 35% in elk herds colonized by wolves as annual population growth shifted from increasing to decreasing. Negative effects of population density and winter severity on recruitment, long recognized as important for elk dynamics, were detected in uncolonized elk herds and in wolf-colonized elk herds prior to wolf colonization, but not after wolf colonization. Growing season precipitation and harvest had no detectable effect on recruitment in either wolf treatment or colonization period, although harvest rates of juveniles∶females declined by 37% in wolf-colonized herds. Even if it is assumed that mortality due to predation is completely additive, liberal estimates of wolf predation rates on juvenile elk could explain no more than 52% of the total decline in juvenile∶female ratios in wolf-colonized herds, after accounting for the effects of other limiting factors. Collectively, these long-term, large-scale patterns align well with prior studies that have reported substantial decrease in elk numbers immediately after wolf recolonization, relatively weak additive effects of direct wolf predation on elk survival, and decreased reproduction and recruitment with exposure to predation risk from wolves.

  13. Implementation of a Manualized Communication Intervention for School-Aged Children with Pragmatic and Social Communication Needs in a Randomized Controlled Trial: The Social Communication Intervention Project

    Science.gov (United States)

    Adams, Catherine; Lockton, Elaine; Gaile, Jacqueline; Earl, Gillian; Freed, Jenny

    2012-01-01

    Background: Speech-language interventions are often complex in nature, involving multiple observations, variable outcomes and individualization in treatment delivery. The accepted procedure associated with randomized controlled trials (RCT) of such complex interventions is to develop and implement a manual of intervention in order that reliable…

  14. Effectiveness of a multifaceted implementation strategy on physicians' referral behavior to an evidence-based psychosocial intervention in dementia: a cluster randomized controlled trial

    NARCIS (Netherlands)

    Dopp, C.M.E.; Graff, M.J.L.; Teerenstra, S.; Sanden, M.W.; Olde Rikkert, M.G.M.; Vernooij-Dassen, M.J.F.J.

    2013-01-01

    BACKGROUND: To evaluate the effectiveness of a multifaceted implementation strategy on physicians' referral rate to and knowledge on the community occupational therapy in dementia program (COTiD program). METHODS: A cluster randomized controlled trial with 28 experimental and 17 control clusters was

  15. From Planning to Implementation: An Examination of Changes in the Research Design, Sample Size, and Precision of Group Randomized Trials Launched by the Institute of Education Sciences

    Science.gov (United States)

    Spybrook, Jessaca; Puente, Anne Cullen; Lininger, Monica

    2013-01-01

    This article examines changes in the research design, sample size, and precision between the planning phase and implementation phase of group randomized trials (GRTs) funded by the Institute of Education Sciences. Thirty-eight GRTs funded between 2002 and 2006 were examined. Three studies revealed changes in the experimental design. Ten studies…

  16. Effectiveness of a training package for implementing a community-based occupational therapy program in dementia: a cluster randomized controlled trial

    NARCIS (Netherlands)

    Dopp, C.M.; Graff, M.J.; Teerenstra, S.; Olde Rikkert, M.G.M.; Sanden, M.W. van der; Vernooij-Dassen, M.J.

    2015-01-01

    OBJECTIVE: Evaluate the effectiveness of a training package to implement a community occupational therapy program for people with dementia and their caregiver (COTiD). DESIGN: Cluster randomized controlled trial. SUBJECTS: A total of 45 service units including 94 occupational therapists, 48 managers

  17. Trials at Sea: Successful Implementation of a Unique Two-Month Professional Development Program

    Science.gov (United States)

    Peart, L. W.; Orcutt, B. N.; Fisher, A. T.; Tsuji, T.; Petronotis, K. E.; Iodp Expedition 327 Participants

    2010-12-01

    During the summer of 2010, Integrated Ocean Drilling Program (IODP) Expedition 327 conducted coring and observatory installations on the Juan de Fuca Plate to characterize the hydrogeology of ridge-flank ocean crust. Due to the nature of the expedition, a smaller science party than usual was needed. IODP took this opportunity to expand education, outreach, and communication (EOC) activities with a previously untested model. Up to now, the IODP U.S. Implementing Organization had sailed either individual teachers on regular (2-month long) expeditions or groups of teachers and informal educators during short (2-week long) transits (School of Rock workshops). After two shipboard (Expeditions 312 and 321T) and two shore-based (Gulf Coast Repository) programs, we have recognized that sailing a group of educators is a beneficial model for IODP and the participants. What has been unavoidable is that these workshops took place outside typical expedition activities. Expedition 327 provided a unique opportunity to sail a diverse group of outreach officers on a regular expedition with a full range of scientific activities. The group included individuals with a wide variety of skills and backgrounds. US participants included a late-career high school physics teacher, a visualization graduate student, an undergraduate engineering student from an historically black university, and an artist. French participants included two middle and high school earth and life science teachers. This diversity made the group more dynamic but it also posed a challenge. Numerous scientific and technical staff also participated in EOC activity design and leadership, including development of dedicated web sites and blogs. After a seminar on constructivist and inquiry-based methods, we spent the first few weeks investigating earth science concepts so EOC participants could gain a basic understanding of the regional geology and the scientific objectives of the expedition. Close to the beginning of the

  18. Implementing GLOBE in the New York City Metropolitan Area: Trials, Errors, and Successes

    Science.gov (United States)

    Ludman, A.; Schmidt, P.; Borman, G.

    2003-12-01

    The Queens College GLOBE NY Metro Partnership was created to introduce GLOBE to more than 1.5 million students in southern NY State and provide continuing support for their teachers. In our first 18 months, we have trained 185 teachers from 82 schools and will triple these numbers this year. Teachers and administrators are attracted to GLOBE by its scientific rigor, the authentic research it offers students, and its fit with NYS standards. They are also eager to interact with our science faculty. Early difficulties included problems with the "standard" 5-day GLOBE training format and misconceptions that protocols are not suitable for urban settings and that preparing for the NYS Regents exams leaves no room for GLOBE. We held information meetings for school districts and for Queens high schools before our first workshop. These identified the most committed schools, energetic teachers, and potential implementation problems. Creative participants at these meetings countered the misconceptions and suggested solutions to the problems better than any outsider could, and generated an atmosphere leading to nearly 100% recruitment. The following stratagems have worked well: a close working relationship with the NYC Dept of Education, BOCES, and other environmental educators; affiliations with government agencies and community environmental groups; two bribes (giving a GLOBE instrument kit and GPS unit to each school that we train and awarding graduate or professional development credits for GLOBE training); a user-friendly training format (an initial 3-day workshop followed by two optional days for hydrology and land use); lending seldom-used items (e.g. soil auger) when needed; building a sense of GLOBE community with a graduation "ceremony", local website (www.qc.edu/qcglobe) and newsletter, phone and email helplines, and annual pedagogy and student research conferences. We also urge that three teachers be trained from each school in order to build local GLOBE support

  19. Implementation of blinded outcome assessment in the Effective Verruca Treatments trial (EverT) – lessons learned

    OpenAIRE

    Cockayne, Sarah; Hewitt, Catherine; Hashmi, Farina; Hicks, Kate; Concannon, Michael; McIntosh, Caroline; Thomas, Kim; Hall, Jill; Watson, Judith; Torgerson, David; Watt, Ian

    2016-01-01

    Background Trials using inadequate levels of blinding may report larger effect sizes than blinded studies. It has been suggested that blinded outcome assessment in open trials may in some cases be undertaken by assessments of photographs. The aim of this paper is to explore the effect of using different methods to assess the primary outcome in the EVerT (Effective Verruca Treatments) trial. It also aims to give an overview of the experiences of using digital photographs within the trial. Meth...

  20. Assessing the detection, reporting and investigation of adverse events in clinical trial protocols implemented in Cameroon: a documentary review of clinical trial protocols

    OpenAIRE

    Ebile, Akoh Walter; Ateudjieu, Jerome; Yakum, Martin Ndinakie; Djuidje, Marceline Ngounoue; Watcho, Pierre

    2015-01-01

    Background International guidelines recommend ethical and scientific quality standards for managing and reporting adverse events occurring during clinical trials to competent research ethics committees and regulatory authorities. The purpose of this study was to determine whether clinical trial protocols in Cameroon are developed in line with national requirements and international guidelines as far as detecting, reporting and investigating of adverse events is concerned. Methods It was a doc...

  1. Sleep hygiene intervention for youth aged 10 to 18 years with problematic sleep: a before-after pilot study

    Directory of Open Access Journals (Sweden)

    Tan Evan

    2012-12-01

    Full Text Available Abstract Background The current study aimed to examine the changes following a sleep hygiene intervention on sleep hygiene practices, sleep quality, and daytime symptoms in youth. Methods Participants aged 10–18 years with self-identified sleep problems completed our age-appropriate F.E.R.R.E.T (an acronym for the categories of Food, Emotions, Routine, Restrict, Environment and Timing sleep hygiene programme; each category has three simple rules to encourage good sleep. Participants (and parents as appropriate completed the Adolescent Sleep Hygiene Scale (ASHS, Pittsburgh Sleep Quality Index (PSQI, Sleep Disturbance Scale for Children (SDSC, Pediatric Daytime Sleepiness Scale (PDSS, and wore Actical® monitors twice before (1 and 2 weeks and three times after (6, 12 and 20 weeks the intervention. Anthropometric data were collected two weeks before and 20 weeks post-intervention. Results Thirty-three youths (mean age 12.9 years; M/F = 0.8 enrolled, and retention was 100%. ASHS scores significantly improved (p = 0.005 from a baseline mean (SD of 4.70 (0.41 to 4.95 (0.31 post-intervention, as did PSQI scores [7.47 (2.43 to 4.47 (2.37; p  Conclusions Our findings suggest the F.E.R.R.E.T sleep hygiene education programme might be effective in improving sleep in children and adolescents. However because this was a before and after study and a pilot study with several limitations, the findings need to be addressed with caution, and would need to be replicated within a randomised controlled trial to prove efficacy. Trial registration Australian New Zealand Clinical Trials Registry: ACTRN12612000649819

  2. Integration of Provider, Pharmacy, and Patient-Reported Data to Improve Medication Adherence for Type 2 Diabetes: A Controlled Before-After Pilot Study

    Science.gov (United States)

    Alzeer, Abdullah H; Phillips, Erin O'Kelly; Marrero, David G

    2016-01-01

    Background Patients with diabetes often have poor adherence to using medications as prescribed. The reasons why, however, are not well understood. Furthermore, most health care delivery processes do not routinely assess medication adherence or the factors that contribute to poor adherence. Objective The objective of the study was to assess the feasibility of an integrated informatics approach to aggregating and displaying clinically relevant data with the potential to identify issues that may interfere with appropriate medication utilization and facilitate patient-provider communication during clinical encounters about strategies to improve medication use. Methods We developed a clinical dashboard within an electronic health record (EHR) system that uses data from three sources: the medical record, pharmacy claims, and a patient portal. Next, we implemented the dashboard into three community health centers. Health care providers (n=15) and patients with diabetes (n=96) were enrolled in a before-after pilot to test the system’s impact on medication adherence and clinical outcomes. To measure adherence, we calculated the proportion of days covered using pharmacy claims. Demographic, laboratory, and visit data from the EHR were analyzed using pairwise t tests. Perceived barriers to adherence were self-reported by patients. Providers were surveyed about their use and perceptions of the clinical dashboard. Results Adherence significantly and meaningfully improved (improvements ranged from 6%-20%) consistently across diabetes as well as cardiovascular drug classes. Clinical outcomes, including HbA1c, blood pressure, lipid control, and emergency department utilization remained unchanged. Only a quarter of patients (n=24) logged into the patient portal and completed psychosocial questionnaires about their barriers to taking medications. Conclusions Integrated approaches using advanced EHR, clinical decision support, and patient-controlled technologies show promise for

  3. Implementation trial of high performance trace analysis/environmental sampling (HPTA/ES) in uranium centrifuge enrichment plants

    International Nuclear Information System (INIS)

    Field trials have demonstrated that the analysis of particles upon swipes obtained from inside nuclear installations provides clear signatures of past operations in that installation. This can offer a valuable tool for gaining assurance regarding the compliance with declared activities and the absence of undeclared activities (e.g. enrichment, reprocessing, and reactor operation) at such sites. This method, known as 'Environmental Sampling' (ES) or 'High Performance Trace Analysis' (HPTA) in EURATOM terminology, is at present being evaluated by the EURATOM Safeguards Directorate (ESD) in order to assess its possible use in nuclear installations within the European Union. It is expected that incorporation of HPTA/ES of sample collection and analysis into routine inspection activities will allow EURATOM to improve the effectiveness of safeguards in these installations and hopefully save inspection resources as well. The EURATOM Safeguards Directorate has therefore performed implementation trials involving the collection of particles by the so-called swipe sampling method in uranium centrifuge enrichment plants and hot cells in the European Union. These samples were subsequently analysed by the Joint Research Centre, Institute for Transuranium Elements (ITU) in Karlsruhe. Sampling points were chosen on the basis of the activities performed in the vicinity and by considering the possible ways through which particles are released, diffused and transported. The aim was to test the efficiency of the method as regards: the collection of enough representative material; the identification of a large enough number of uranium particles; the accurate measurement of the enrichment of the uranium particles found on the swipe; the representativity of the results in respect of past activities in the plant; the capability of detecting whether highly enriched uranium has been produced, used or occasionally transported in a location where low enriched uranium is routinely produced in

  4. An outreach intervention to implement evidence based practice in residential care: a randomized controlled trial [ISRCTN67855475

    Directory of Open Access Journals (Sweden)

    Weller David

    2004-04-01

    Full Text Available Abstract Background The aim of this project was to assess whether outreach visits would improve the implementation of evidence based clinical practice in the area of falls reduction and stroke prevention in a residential care setting. Methods Twenty facilities took part in a randomized controlled trial with a seven month follow-up period. Two outreach visits were delivered by a pharmacist. At the first a summary of the relevant evidence was provided and at the second detailed audit information was provided about fall rates, psychotropic drug prescribing and stroke risk reduction practices (BP monitoring, aspirin and warfarin use for the facility relevant to the physician. The effect of the interventions was determined via pre- and post-intervention case note audit. Outcomes included change in percentage patients at risk of falling who fell in a three month period prior to follow-up and changes in use of psychotropic medications. Chi-square tests, independent samples t-test, and logistic regression were used in the analysis. Results Data were available from case notes at baseline (n = 897 and seven months follow-up (n = 902, 452 residential care staff were surveyed and 121 physicians were involved with 61 receiving outreach visits. Pre-and post-intervention data were available for 715 participants. There were no differences between the intervention and control groups for the three month fall rate. We were unable to detect statistically significant differences between groups for the psychotropic drug use of the patients before or after the intervention. The exception was significantly greater use of "as required" antipsychotics in the intervention group compared with the control group after the pharmacy intervention (RR = 4.95; 95%CI 1.69–14.50. There was no statistically significant difference between groups for the numbers of patients "at risk of stroke" on aspirin at follow-up. Conclusions While the strategy was well received by the

  5. Development, Validation, and Implementation of an Innovative Mobile App for Alcohol Dependence Management: Protocol for the SIDEAL Trial

    Science.gov (United States)

    Ortega, Lluisa; Bona, Xavier; Gual, Antoni

    2016-01-01

    Background Information and communication technologies (ICT) have become one of the main pathways to the new paradigm of increased self-management of chronic conditions such as alcohol dependence. Validation of some mobile phone apps has begun, while validation of many others is forthcoming. Objective To describe the protocol for validation of a new app called SIDEAL (an acronym of the Spanish name “Soporte Innovador a la persona con DEpendencia del ALcohol,” or innovative support for people with alcohol dependence). Methods The project consists of 3 complementary, consecutive studies, including a pilot feasibility study, a qualitative study using focus groups, and, finally, a randomized controlled trial where patients will be randomized to standard treatment or standard treatment plus SIDEAL. During the pilot study, feasibility, usability, and acceptance by users will be the main outcomes explored. An electronic questionnaire will be sent to patients asking for their opinions. Focus groups will be the next step, after which improvements and refinements will be implemented in the app. During the final phase, consumption variables (heavy drinking days per month, mean standard drinks per day) will be investigated, in order to test app efficacy. Results Because of the encouraging results with previous similar apps, we expect patients to widely accept and incorporate SIDEAL into their therapeutic options. Significant reductions in drinking-related variables are also expected. The pilot study has concluded with the inclusion of 29 patients. Results are expected to be available soon (expected mid-2016). Conclusions SIDEAL may represent a useful, reliable, effective, and efficient tool to complement therapeutic options available to both patients and professionals. PMID:26888196

  6. From trial to population: a study of a family-based community intervention for childhood overweight implemented at scale

    Science.gov (United States)

    Fagg, J; Chadwick, P; Cole, T J; Cummins, S; Goldstein, H; Lewis, H; Morris, S; Radley, D; Sacher, P; Law, C

    2014-01-01

    Objectives: To assess how outcomes associated with participation in a family-based weight management intervention (MEND 7–13, Mind, Exercise, Nutrition..Do it!) for childhood overweight or obesity implemented at scale in the community vary by child, family, neighbourhood and MEND programme characteristics. Methods/Subjects: Intervention evaluation using prospective service level data. Families (N=21 132) with overweight children are referred, or self-refer, to MEND. Families (participating child and one parent/carer) attend two sessions/week for 10 weeks (N=13 998; N=9563 with complete data from 1788 programmes across England). Sessions address diet and physical activity through education, skills training and motivational enhancement. MEND was shown to be effective in obese children in a randomised controlled trial (RCT). Outcomes were mean change in body mass index (BMI), age- and sex-standardised BMI (zBMI), self-esteem (Rosenberg scale) and psychological distress (Strengths and Difficulties Questionnaire) after the 10-week programme. Relationships between the outcome and covariates were tested in multilevel models adjusted for the outcome at baseline. Results: After adjustment for covariates, BMI reduced by mean 0.76 kg m−2 (s.e.=0.021, P<0.0001), zBMI reduced by mean 0.18 (s.e.=0.0038, P<0.0001), self-esteem score increased by 3.53 U  (s.e.=0.13, P<0.0001) and psychological distress score decreased by 2.65 U (s.e.=0.31, P<0.0001). Change in outcomes varied by participant, family, neighbourhood and programme factors. Generally, outcomes improved less among children from less advantaged backgrounds and in Asian compared with white children. BMI reduction under service conditions was slightly but not statistically significantly less than in the earlier RCT. Conclusions: The MEND intervention, when delivered at scale, is associated with improved BMI and psychosocial outcomes on average, but may work less well for some groups of children, and so

  7. Evaluation and implementation of graded in vivo exposure for chronic low back pain in a German outpatient setting: a study protocol of a randomized controlled trial

    OpenAIRE

    Riecke, Jenny; Holzapfel, Sebastian; Rief, Winfried; Glombiewski, Julia Anna

    2013-01-01

    Background The purpose of the present study is to introduce an adapted protocol of in vivo exposure for fear avoidant back pain patients and its implementation in the German health care system without multidisciplinary teams. Case studies demonstrated promising effects but three preceding randomized controlled trials (RCTs) could not support the former results. More empirical support is necessary to further substantiate the effectiveness of in vivo exposure. Methods A total of 108 chronic low...

  8. Implementation of a guideline-based clinical pathway of care to improve health outcomes following whiplash injury (Whiplash ImPaCT: protocol of a randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    Trudy Rebbeck

    2016-04-01

    Discussion: This research is significant as it will be the first study to address the heterogeneity of whiplash by implementing a clinical pathway of care that matches evidence-based interventions to projected risk of poor recovery. The results of this trial have the potential to change clinical practice for WAD, thereby maximising treatment effects, improving patient outcomes, reducing costs and maintaining the compulsory third party system.

  9. 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

    OpenAIRE

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

    2009-01-01

    Abstract Background 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 o...

  10. Using theories of behaviour to understand transfusion prescribing in three clinical contexts in two countries: Development work for an implementation trial (protocol)

    OpenAIRE

    Francis, J.; Tinmouth, A; Stanworth, S.; J.M. Grimshaw; Johnston, M.; Hyde, C.; Brehaut, J.; Stockton, C; Fergusson, D.; Eccles, M. P.

    2009-01-01

    Background: Blood transfusion is an essential part of healthcare and can improve patient outcomes. However, like most therapies, it is also associated with significant clinical risks. In addition, there is some evidence of overuse. Understanding the potential barriers and enablers to reduced prescribing of blood products will facilitate the selection of intervention components likely to be effective, thereby reducing the number of costly trials evaluating different implementation strategies. ...

  11. Effectiveness of an intervention to facilitate the implementation of healthy eating and physical activity policies and practices in childcare services: a randomised controlled trial

    OpenAIRE

    Jones, Jannah; Wyse, Rebecca; Finch, Meghan; Lecathelinais, Christophe; Wiggers, John; Marshall, Josephine; Falkiner, Maryann; Pond, Nicole; Yoong, Sze Lin; Hollis, Jenna; Fielding, Alison; Dodds, Pennie; Clinton-McHarg, Tara; Freund, Megan; McElduff, Patrick

    2015-01-01

    Background The primary aim of this study was to evaluate the effectiveness of an intervention to increase the implementation of healthy eating and physical activity policies and practices by centre-based childcare services. The study also sought to determine if the intervention was effective in improving child dietary intake and increasing child physical activity levels while attending childcare. Methods A parallel group, randomised controlled trial was conducted in a sample of 128 childcare ...

  12. A mixed methods pilot study with a cluster randomized control trial to evaluate the impact of a leadership intervention on guideline implementation in home care nursing

    Directory of Open Access Journals (Sweden)

    Tourangeau Ann

    2008-12-01

    Full Text Available Abstract Background Foot ulcers are a significant problem for people with diabetes. Comprehensive assessments of risk factors associated with diabetic foot ulcer are recommended in clinical guidelines to decrease complications such as prolonged healing, gangrene and amputations, and to promote effective management. However, the translation of clinical guidelines into nursing practice remains fragmented and inconsistent, and a recent homecare chart audit showed less than half the recommended risk factors for diabetic foot ulcers were assessed, and peripheral neuropathy (the most significant predictor of complications was not assessed at all. Strong leadership is consistently described as significant to successfully transfer guidelines into practice. Limited research exists however regarding which leadership behaviours facilitate and support implementation in nursing. The purpose of this pilot study is to evaluate the impact of a leadership intervention in community nursing on implementing recommendations from a clinical guideline on the nursing assessment and management of diabetic foot ulcers. Methods Two phase mixed methods design is proposed (ISRCTN 12345678. Phase I: Descriptive qualitative to understand barriers to implementing the guideline recommendations, and to inform the intervention. Phase II: Matched pair cluster randomized controlled trial (n = 4 centers will evaluate differences in outcomes between two implementation strategies. Primary outcome: Nursing assessments of client risk factors, a composite score of 8 items based on Diabetes/Foot Ulcer guideline recommendations. Intervention: In addition to the organization's 'usual' implementation strategy, a 12 week leadership strategy will be offered to managerial and clinical leaders consisting of: a printed materials, b one day interactive workshop to develop a leadership action plan tailored to barriers to support implementation; c three post-workshop teleconferences. Discussion This

  13. Do electronic health records affect the patient-psychiatrist relationship? A before & after study of psychiatric outpatients

    Directory of Open Access Journals (Sweden)

    Schuyler Mark

    2010-01-01

    Full Text Available Abstract Background A growing body of literature shows that patients accept the use of computers in clinical care. Nonetheless, studies have shown that computers unequivocally change both verbal and non-verbal communication style and increase patients' concerns about the privacy of their records. We found no studies which evaluated the use of Electronic Health Records (EHRs specifically on psychiatric patient satisfaction, nor any that took place exclusively in a psychiatric treatment setting. Due to the special reliance on communication for psychiatric diagnosis and evaluation, and the emphasis on confidentiality of psychiatric records, the results of previous studies may not apply equally to psychiatric patients. Method We examined the association between EHR use and changes to the patient-psychiatrist relationship. A patient satisfaction survey was administered to psychiatric patient volunteers prior to and following implementation of an EHR. All subjects were adult outpatients with chronic mental illness. Results Survey responses were grouped into categories of "Overall," "Technical," "Interpersonal," "Communication & Education,," "Time," "Confidentiality," "Anxiety," and "Computer Use." Multiple, unpaired, two-tailed t-tests comparing pre- and post-implementation groups showed no significant differences (at the 0.05 level to any questionnaire category for all subjects combined or when subjects were stratified by primary diagnosis category. Conclusions While many barriers to the adoption of electronic health records do exist, concerns about disruption to the patient-psychiatrist relationship need not be a prominent focus. Attention to communication style, interpersonal manner, and computer proficiency may help maintain the quality of the patient-psychiatrist relationship following EHR implementation.

  14. Implementing good participatory practice guidelines in the FEM-PrEP Preexposure Prophylaxis Trial for HIV Prevention among African Women: a focus on local stakeholder involvement

    Directory of Open Access Journals (Sweden)

    Mack N

    2013-10-01

    Full Text Available Natasha Mack,1 Stella Kirkendale,1 Paul Omullo,2 Jacob Odhiambo,2 Malebo Ratlhagana,3 Martha Masaki,4 Phumzile Siguntu,5 Kawango Agot,2 Khatija Ahmed,3 Saidi Kapiga,4 Johan Lombaard,5 Lut Van Damme,1 Amy Corneli1 1FHI 360, Durham, NC, USA; 2Impact Research and Development Organization, Bondo, Kenya; 3Setshaba Research Centre, Soshanguve, South Africa; 4Kilimanjaro Christian Medical Center, Moshi, Tanzania; 5Josha Research, Bloemfontein, South Africa Abstract: Biomedical HIV-prevention research is most likely to succeed when researchers actively engage with community stakeholders. To this effect, the Joint United Nations Programme on HIV/AIDS and the AIDS Vaccine Advocacy Coalition developed good participatory practice guidelines for biomedical HIV-prevention trials in 2007 and updated them in 2011. The Preexposure Prophylaxis Trial for HIV Prevention among African Women (FEM-PrEP clinical trial, testing once-daily Truvada as preexposure prophylaxis among women at higher risk of HIV in Kenya, South Africa, and Tanzania, included a community program to engage with local stakeholders. Following the trial, we revisited the community program to situate activities in the context of the 2011 guidelines. In the paper, we describe implementation of the six guidelines relevant to local stakeholder engagement – stakeholder advisory mechanisms, stakeholder engagement plan, stakeholder education plan, communications plan, issues management plan, trial closure, and results dissemination – in light of on-the-ground realities of the trial. We then identify two cross-cutting themes from our considerations: (1 stakeholder education beyond the good participatory practice recommendation to increase research literacy about the specific trial is needed; education efforts should also communicate a base of information on HIV transmission and prevention; and (2 anticipatory preparation is useful in communications planning, issues management, and trial closure and

  15. Implementing Randomized Controlled Trials in Preschool Settings That Include Young Children with Disabilities: Considering the Context of Strain and Bovey

    Science.gov (United States)

    Snyder, Patricia

    2011-01-01

    In this commentary, developments related to conducting randomized controlled trials in authentic preschool settings that include young children with disabilities are discussed in relation to the Strain and Bovey study.

  16. 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

    Directory of Open Access Journals (Sweden)

    Keegan Natalie

    2009-09-01

    Full Text Available Abstract Background 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. Methods 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. Discussion 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. Trial Registration Clinical Trials Registration Number: NCT00257088

  17. The effect of a complementary e-learning course on implementation of a quality improvement project regarding care for elderly patients: a stepped wedge trial

    Directory of Open Access Journals (Sweden)

    Van de Steeg Lotte

    2012-03-01

    Full Text Available Abstract Background Delirium occurs frequently in elderly hospitalised patients and is associated with higher mortality, increased length of hospital stay, functional decline, and admission to long-term care. Healthcare professionals frequently do not recognise delirium, indicating that education can play an important role in improving delirium care for hospitalised elderly. Previous studies have indicated that e-learning can provide an effective way of educating healthcare professionals and improving quality of care, though results are inconsistent. Methods and design This stepped wedge cluster randomised trial will assess the effects of a complementary delirium e-learning course on the implementation of quality improvement initiative, which aims to enhance the recognition and management of delirium in elderly patients. The trial will be conducted in 18 Dutch hospitals and last 11 months. Measurements will be taken in all participating wards using monthly record reviews, in order to monitor delivered care. These measurements will include the percentage of elderly patients who were screened for the risk of developing delirium, use of the Delirium Observation Screening scale, use of nursing or medical interventions, and the percentage of elderly patients who were diagnosed with delirium. Data regarding the e-learning course will be gathered as well. These data will include user characteristics, information regarding use of the course, delirium knowledge before and after using the course, and the attitude and intentions of nurses concerning delirium care. Setting The study will be conducted in internal medicine and surgical wards of eighteen hospitals that are at the beginning stages of implementing the Frail Elderly Project in the Netherlands. Discussion Better recognition of elderly patients at risk for delirium and subsequent care is expected from the introduction of an e-learning course for nurses that is complementary to an existing quality

  18. Implementation strategies of internet-based asthma self-management support in usual care. Study protocol for the IMPASSE cluster randomized trial

    Directory of Open Access Journals (Sweden)

    van Gaalen Johanna L

    2012-11-01

    Full Text Available Abstract Background Internet-based self-management (IBSM support cost-effectively improves asthma control, asthma related quality of life, number of symptom-free days, and lung function in patients with mild to moderate persistent asthma. The current challenge is to implement IBSM in clinical practice. Methods/design This study is a three-arm cluster randomized trial with a cluster pre-randomisation design and 12 months follow-up per practice comparing the following three IBSM implementation strategies: minimum strategy (MS: dissemination of the IBSM program; intermediate strategy (IS: MS + start-up support for professionals (i.e., support in selection of the appropriate population and training of professionals; and extended strategy (ES: IS + additional training and ongoing support for professionals. Because the implementation strategies (interventions are primarily targeted at general practices, randomisation will occur at practice level. In this study, we aim to evaluate 14 primary care practices per strategy in the Leiden-The Hague region, involving 140 patients per arm. Patients aged 18 to 50 years, with a physician diagnosis of asthma, prescription of inhaled corticosteroids, and/or montelukast for ≥3 months in the previous year are eligible to participate. Primary outcome measures are the proportion of referred patients that participate in IBSM, and the proportion of patients that have clinically relevant improvement in the asthma-related quality of life. The secondary effect measures are clinical outcomes (asthma control, lung function, usage of airway treatment, and presence of exacerbations; self-management related outcomes (health education impact, medication adherence, and illness perceptions; and patient utilities. Process measures are the proportion of practices that participate in IBSM and adherence of professionals to implementation strategies. Cost-effective measurements are medical costs and healthcare consumption

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

    NARCIS (Netherlands)

    Dopp, C.M.E.; Graff, M.J.L.; Teerenstra, S.; Adang, E.M.M.; Nijhuis-Van der Sanden, R.; Olde Rikkert, M.G.M.; Vernooij-Dassen, M.J.F.J.

    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

  20. Implementation of Evidence-Based Models in Social Work Practice: Practitioners' Perspectives on an MST Trial in Sweden

    Science.gov (United States)

    Gustle, Lars-Henry; Hansson, Kjell; Sundell, Knut; Andree-Lofholm, Cecilia

    2008-01-01

    The implementation of new treatment methods in social work practice is warranted. Moreover, little is known about professionals' attitudes toward the introduction of evidence-based practices into their communities. Therefore, this article reports on the implementation of a Swedish research project that evaluated Multisystemic Therapy (MST). All…

  1. Barriers to and facilitators of implementing complex workplace dietary interventions: process evaluation results of a cluster controlled trial

    OpenAIRE

    Fitzgerald, Sarah; Geaney, Fiona; Kelly, Clare; McHugh, Sheena; Perry, Ivan J

    2016-01-01

    Background Ambiguity exists regarding the effectiveness of workplace dietary interventions. Rigorous process evaluation is vital to understand this uncertainty. This study was conducted as part of the Food Choice at Work trial which assessed the comparative effectiveness of a workplace environmental dietary modification intervention and an educational intervention both alone and in combination versus a control workplace. Effectiveness was assessed in terms of employees’ dietary intakes, nutri...

  2. Supervised versus non-supervised implementation of an oral health care guideline in (residential care homes: a cluster randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    de Baat Cees

    2010-07-01

    Full Text Available Abstract Background The increase of the proportion of elderly people has implications for health care services. Advances in oral health care and treatment have resulted in a reduced number of edentulous individuals. An increasing number of dentate elderly people have tooth wear, periodontal disease, oral implants, and sophisticated restorations and prostheses. Hence, they are in need of both preventive and curative oral health care continuously. Weakened oral health due to neglect of self care and professional care and due to reduced oral health care utilization is already present when elderly people are still community-dwelling. At the moment of (residential care home admittance, many elderly people are in need of oral health care urgently. The key factor in realizing and maintaining good oral health is daily oral hygiene care. For proper daily oral hygiene care, many residents are dependent on nurses and nurse aides. In 2007, the Dutch guideline "Oral health care in (residential care homes for elderly people" was developed. Previous implementation research studies have revealed that implementation of a guideline is very complicated. The overall aim of this study is to compare a supervised versus a non-supervised implementation of the guideline in The Netherlands and Flanders (Belgium. Methods/Design The study is a cluster randomized intervention trial with an institution as unit of randomization. A random sample of 12 (residential care homes accommodating somatic as well as psycho-geriatric residents in The Netherlands as well as in Flanders (Belgium are randomly allocated to an intervention or control group. Representative samples of 30 residents in each of the 24 (residential care homes are monitored during a 6-months period. The intervention consists of supervised implementation of the guideline and a daily oral health care protocol. Primary outcome variable is the oral hygiene level of the participating residents. To determine the

  3. Implementing nurse-initiated and managed antiretroviral treatment (NIMART) in South Africa: a qualitative process evaluation of the STRETCH trial

    OpenAIRE

    Georgeu Daniella; Colvin Christopher J; Lewin Simon; Fairall Lara; Bachmann Max O; Uebel Kerry; Zwarenstein Merrick; Draper Beverly; Bateman Eric D

    2012-01-01

    Abstract Background Task-shifting is promoted widely as a mechanism for expanding antiretroviral treatment (ART) access. However, the evidence for nurse-initiated and managed ART (NIMART) in Africa is limited, and little is known about the key barriers and enablers to implementing NIMART programmes on a large scale. The STRETCH (Streamlining Tasks and Roles to Expand Treatment and Care for HIV) programme was a complex educational and organisational intervention implemented in the Free State P...

  4. Implementation of patient education at first and second dispensing of statins in Dutch community pharmacies: the sequel of a cluster randomized trial

    Directory of Open Access Journals (Sweden)

    Van de Steeg-van Gompel Caroline HPA

    2011-11-01

    Full Text Available Abstract Background As a result of the previous part of this trial, many patients with cardiovascular disease were expected to receive a statin for the first time. In order to provide these patients with comprehensive information on statins, as recommended by professional guidance, education at first and second dispensing of statins had to be implemented. This study was designed to assess the effectiveness of an intensive implementation program targeted at pharmacy project assistants on the frequency of providing education at first dispensing (EAFD and education at second dispensing (EASD of statins in community pharmacies. Methods The participating community pharmacies were clustered on the basis of local collaboration, were numbered by a research assistant and subsequently an independent statistician performed a block randomization, in which the cluster size (number of pharmacies in each cluster was balanced. The pharmacies in the control group received a written manual on the implementation of EAFD and EASD; the pharmacies in the intervention group received intensive support for the implementation. The impact of the intensive implementation program on the implementation process and on the primary outcomes was examined in a random coefficient logistic regression model, which took into account that patients were grouped within pharmacy clusters. Results Of the 37 pharmacies in the intervention group, 17 pharmacies (50% provided EAFD and 12 pharmacies (35.3% provided EASD compared to 14 pharmacies (45.2%, P = 0.715 and 12 pharmacies (38.7%, P = 0.899, respectively, of the 34 pharmacies in the control group. In the intervention group a total of 72 of 469 new statin users (15.4% received education and 49 of 393 patients with a second statin prescription (12.5% compared to 78 of 402 new users (19.4%, P = 0.944 and 35 of 342 patients with a second prescription (10.2%, P = 0.579 in the control group. Conclusion The intensive implementation program

  5. A cluster randomized controlled trial aimed at implementation of local quality improvement collaboratives to improve prescribing and test ordering performance of general practitioners: Study Protocol

    Directory of Open Access Journals (Sweden)

    Winkens Ron

    2009-02-01

    Full Text Available Abstract Background The use of guidelines in general practice is not optimal. Although evidence-based methods to improve guideline adherence are available, variation in physician adherence to general practice guidelines remains relatively high. The objective for this study is to transfer a quality improvement strategy based on audit, feedback, educational materials, and peer group discussion moderated by local opinion leaders to the field. The research questions are: is the multifaceted strategy implemented on a large scale as planned?; what is the effect on general practitioners' (GPs test ordering and prescribing behaviour?; and what are the costs of implementing the strategy? Methods In order to evaluate the effects, costs and feasibility of this new strategy we plan a multi-centre cluster randomized controlled trial (RCT with a balanced incomplete block design. Local GP groups in the south of the Netherlands already taking part in pharmacotherapeutic audit meeting groups, will be recruited by regional health officers. Approximately 50 groups of GPs will be randomly allocated to two arms. These GPs will be offered two different balanced sets of clinical topics. Each GP within a group will receive comparative feedback on test ordering and prescribing performance. The feedback will be discussed in the group and working agreements will be created after discussion of the guidelines and barriers to change. The data for the feedback will be collected from existing and newly formed databases, both at baseline and after one year. Discussion We are not aware of published studies on successes and failures of attempts to transfer to the stakeholders in the field a multifaceted strategy aimed at GPs' test ordering and prescribing behaviour. This pragmatic study will focus on compatibility with existing infrastructure, while permitting a certain degree of adaptation to local needs and routines. Trial registration Nederlands Trial Register ISRCTN40008171

  6. Implementation of Remote 3-Dimensional Image Guided Radiation Therapy Quality Assurance for Radiation Therapy Oncology Group Clinical Trials

    International Nuclear Information System (INIS)

    Purpose: To report the process and initial experience of remote credentialing of three-dimensional (3D) image guided radiation therapy (IGRT) as part of the quality assurance (QA) of submitted data for Radiation Therapy Oncology Group (RTOG) clinical trials; and to identify major issues resulting from this process and analyze the review results on patient positioning shifts. Methods and Materials: Image guided radiation therapy datasets including in-room positioning CT scans and daily shifts applied were submitted through the Image Guided Therapy QA Center from institutions for the IGRT credentialing process, as required by various RTOG trials. A centralized virtual environment is established at the RTOG Core Laboratory, containing analysis tools and database infrastructure for remote review by the Physics Principal Investigators of each protocol. The appropriateness of IGRT technique and volumetric image registration accuracy were evaluated. Registration accuracy was verified by repeat registration with a third-party registration software system. With the accumulated review results, registration differences between those obtained by the Physics Principal Investigators and from the institutions were analyzed for different imaging sites, shift directions, and imaging modalities. Results: The remote review process was successfully carried out for 87 3D cases (out of 137 total cases, including 2-dimensional and 3D) during 2010. Frequent errors in submitted IGRT data and challenges in the review of image registration for some special cases were identified. Workarounds for these issues were developed. The average differences of registration results between reviewers and institutions ranged between 2 mm and 3 mm. Large discrepancies in the superior-inferior direction were found for megavoltage CT cases, owing to low spatial resolution in this direction for most megavoltage CT cases. Conclusion: This first experience indicated that remote review for 3D IGRT as part of QA

  7. Factors that influenced county system leaders to implement an evidence-based program: a baseline survey within a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Brown C Hendricks

    2010-10-01

    Full Text Available Abstract Background Despite the burgeoning number of well-validated interventions that have been shown in randomized trials to produce superior outcomes compared to usual services, it is estimated that only 10% of public systems deliver evidence-based mental health services. In California, for example, more than 15,000 children are placed in group homes or residential centers with some evidence of iatrogenic effects. The present study evaluates the willingness among county leaders of child public service systems to adopt a new evidence-based model, Multidimensional Treatment Foster Care, (MTFC, as a way to decrease the prevalence of out-of-home placements. Specifically, the study examines how county-level socio-demographic factors and child public service system leaders' perceptions of their county's organizational climate influence their decision of whether or not to consider adopting MTFC. Methods Two levels were examined in this study: Stable and historical factors from 40 California counties gathered from public records including population size, number of entries into out-of-home care, financing of mental health services, and percent minority population; and system leaders' perceptions of their county's organizational climate and readiness for change measured via a web-based survey. The number of days-to-consent was the primary outcome variable defined as the duration of time between being notified of the opportunity to implement MTFC and the actual signing of a consent form indicating interest in considering implementation. Survival analysis methods were used to assess the predictors of this time-to-event measure. The present study is part of a larger randomized trial comparing two methods of implementation where counties are randomized to one of three time cohorts and two implementation conditions. Results The number of entries into care was the primary predictor of days-to-consent. This variable was significantly correlated to county

  8. Preventive evidence into practice (PEP study: implementation of guidelines to prevent primary vascular disease in general practice protocol for a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Harris Mark F

    2013-01-01

    Full Text Available Abstract Background There are significant gaps in the implementation and uptake of evidence-based guideline recommendations for cardiovascular disease (CVD and diabetes in Australian general practice. This study protocol describes the methodology for a cluster randomised trial to evaluate the effectiveness of a model that aims to improve the implementation of these guidelines in Australian general practice developed by a collaboration between researchers, non-government organisations, and the profession. Methods We hypothesise that the intervention will alter the behaviour of clinicians and patients resulting in improvements of recording of lifestyle and physiological risk factors (by 20% and increased adherence to guideline recommendations for: the management of CVD and diabetes risk factors (by 20%; and lifestyle and physiological risk factors of patients at risk (by 5%. Thirty-two general practices will be randomised in a 1:1 allocation to receive either the intervention or continue with usual care, after stratification by state. The intervention will be delivered through: small group education; audit of patient records to determine preventive care; and practice facilitation visits adapted to the needs of the practices. Outcome data will be extracted from electronic medical records and patient questionnaires, and qualitative evaluation from provider and patient interviews. Discussion We plan to disseminate study findings widely and directly inform implementation strategies by governments, professional bodies, and non-government organisations including the partner organisations.

  9. Gaining control over responses to implicit attitude tests: Implementation intentions engender fast responses on attitude-incongruent trials.

    Science.gov (United States)

    Webb, Thomas L; Sheeran, Paschal; Pepper, John

    2012-03-01

    The present research investigated whether forming implementation intentions could promote fast responses to attitude-incongruent associations (e.g., woman-manager) and thereby modify scores on popular implicit measures of attitude. Expt 1 used the Implicit Association Test (IAT) to measure associations between gender and science versus liberal arts. Planning to associate women with science engendered fast responses to this category-attribute pairing and rendered summary scores more neutral compared to standard IAT instructions. Expt 2 demonstrated that forming egalitarian goal intentions is not sufficient to produce these effects. Expt 3 extended these findings to a different measure of implicit attitude (the Go/No-Go Association Task) and a different stereotypical association (Muslims-terrorism). In Expt 4, managers who planned to associate women with superordinate positions showed more neutral IAT scores relative to non-planners and effects were maintained 3 weeks later. In sum, implementation intentions enable people to gain control over implicit attitude responses. PMID:22435844

  10. From trial to population: a study of a family-based community intervention for childhood overweight implemented at scale.

    OpenAIRE

    Fagg, J.; Chadwick, P.; Cole, T J; Cummins, S; Goldstein, H; Lewis, H; MORRIS, S.; Radley, D.; Sacher, P; Law, C.

    2014-01-01

    Objectives: To assess how outcomes associated with participation in a family-based weight management intervention (MEND 7–13, Mind, Exercise, Nutrition..Do it!) for childhood overweight or obesity implemented at scale in the community vary by child, family, neighbourhood and MEND programme characteristics. Methods/Subjects: Intervention evaluation using prospective service level data. Families (N=21 132) with overweight children are referred, or self-refer, to MEND. Families (participating ch...

  11. Assessing fidelity of cognitive behavioral therapy in rural VA clinics: design of a randomized implementation effectiveness (hybrid type III) trial

    OpenAIRE

    Cucciare, Michael A.; Curran, Geoffrey M; Craske, Michelle G.; Abraham, Traci; McCarthur, Michael B.; Marchant-Miros, Kathy; Lindsay, Jan A.; Kauth, Michael R.; Landes, Sara J.; Sullivan, Greer

    2016-01-01

    Background Broadly disseminating and implementing evidence-based psychotherapies with high fidelity, particularly cognitive behavioral therapy (CBT), has proved challenging for many health-care systems, including the Department of Veterans Affairs, especially in primary care settings such as small or remote clinics. A computer-based tool (based on the coordinated anxiety learning and management (CALM) program) was designed to support primary care-based mental health providers in delivering CB...

  12. Introducing rapid diagnostic tests for malaria into drug shops in Uganda: design and implementation of a cluster randomized trial

    OpenAIRE

    Mbonye, AK; Magnussen, P.; Chandler, CI; Hansen, KS; Lal, S; Cundill, B; Lynch, CA; Clarke, SE

    2014-01-01

    Background An intervention was designed to introduce rapid diagnostics tests for malaria (mRDTs) into registered drug shops in Uganda to encourage rational and appropriate treatment of malaria with artemisinin-based combination therapy (ACT). We conducted participatory training of drug shop vendors and implemented supporting interventions to orientate local communities (patients) and the public sector (health facility staff and district officials) to the behavioral changes in diagnosis, treat...

  13. Sustaining the Control of Schistosoma mansoni in Western Côte d'Ivoire: Baseline Findings Before the Implementation of a Randomized Trial.

    Science.gov (United States)

    Assaré, Rufin K; Hürlimann, Eveline; Ouattara, Mamadou; N'Guessan, Nicaise A; Tian-Bi, Yves-Nathan T; Yapi, Ahoua; Yao, Patrick K; Coulibaly, Jean T; Knopp, Stefanie; N'Goran, Eliézer K; Utzinger, Jürg

    2016-02-01

    We report baseline findings before the implementation of a 4-year intervention trial designed to assess the impact of three different school-based treatment schedules with praziquantel to sustain the control of intestinal schistosomiasis. The baseline survey was conducted in 75 schools of western Côte d'Ivoire previously identified with moderate Schistosoma mansoni endemicity (prevalence: 10-24% in children aged 13-14 years). Three stool samples collected over consecutive days were subjected to duplicate Kato-Katz thick smears each. A questionnaire was administered to collect village-specific information that is relevant for schistosomiasis transmission. Overall, 4,953 first graders (aged 5-8 years) and 7,011 school children (aged 9-12 years) had complete parasitologic data. The overall prevalence of S. mansoni was 5.4% among first graders and 22.1% in 9- to 12-year-old children. Open defecation was practiced in all villages. The current baseline findings will be important to better understand the dynamics of S. mansoni prevalence and intensity over the course of this trial that might be governed by village characteristics and specific treatment interventions. PMID:26598571

  14. Implementation of mother-training program to improve parenting in pre-school age children: A randomized-controlled trial

    Directory of Open Access Journals (Sweden)

    Esmaeili Douki Zahra

    2014-01-01

    Full Text Available Background : Preventing child abuse is an area of evaluation that should be deeply considered. The enhancing skill of maternal child care is also useful in this field. Aim: The aim of this study was to assess the impact of a training strategy to improve parenting in the families identified as at risk of child maltreatment. Materials and Methods : This randomized and controlled trial was conducted in 60 mothers allocated in the experimental and controlled group by a simple random allocation in Amirkola Children′s Hospital in North Iran from January 2009 to December 2009. Mean score of maternal child abuse before and after intervention has been assessed by Conflict Tactics Scale for Parent and Child. Data analysis was based on the independent t-test, the paired t-test and one way analysis of variance. Results : The mean and standard deviation of maternal child abuse score in the experimental group before and after intervention were 30.21 ± 1.21 and 23.31 ± 1.52, respectively, (P < 0.001, t = 6.63, but no difference was found in the control group. Conclusions : The training program on maternal skills to prevent child abuse was a powerful resource. Therefore, healthcare providers in the field of pediatric about parenting skills should be taught with a specific consideration.

  15. [Communication in the context of phase I clinical trials in oncology: implementation and evaluation of training programs].

    Science.gov (United States)

    Rouby, Pascal; Hollebecque, Antoine; Bahleda, Ratislav; Deutsch, Eric; Gomez-Rocca, Carlos; Angevin, Eric; de La Motte Rouge, Thibault; Soria, Jean-Charles; Dauchy, Sarah

    2015-02-01

    Communication training programs in oncology have demonstrated some efficacy to improve doctors' communication skills. The goal of our study was to evaluate the impact of such training in the particular context of phase I clinical trials. Self-satisfaction and self-efficacy scales evaluating doctor-patient communication was completed by 6 medical oncologists (3 juniors and 3 seniors) before and after their communication training for a total of sixty visits. Two types of visit have been distinguished: the visits between the oncologist and the patient alone (a dual situation) and those with a third party (a trilateral situation). For all the doctors in dual and trialateral situations, self-efficacy scores improved significantly after training. This improvement was more pronounced for juniors oncologists in trilateral situations. Before training, satisfactory scores were worst in duel versus trilateral situations (P=0.01). This was particularly pronounced for junior compared to senior doctors (P=0.035). After training, in trilateral situations, the satisfaction scores of junior doctors matched that of the senior doctors. The communication training programs appear to benefit junior oncologists to a greater extent in trilateral situations. PMID:25609484

  16. CAFÉ: a multicomponent audit and feedback intervention to improve implementation of healthy food policy in primary school canteens: protocol of a randomised controlled trial

    Science.gov (United States)

    Williams, Christopher M; Nathan, Nicole; Delaney, Tessa; Yoong, Sze Lin; Wiggers, John; Preece, Sarah; Lubans, Nicole; Sutherland, Rachel; Pinfold, Jessica; Smith, Kay; Small, Tameka; Reilly, Kathryn L; Butler, Peter; Wyse, Rebecca J; Wolfenden, Luke

    2015-01-01

    Introduction A number of jurisdictions internationally have policies requiring schools to implement healthy canteens. However, many schools have not implemented such policies. One reason for this is that current support interventions cannot feasibly be delivered to large numbers of schools. A promising solution to support population-wide implementation of healthy canteen practices is audit and feedback. The effectiveness of this strategy has, however, not previously been assessed in school canteens. This study aims to assess the effectiveness and cost-effectiveness of an audit and feedback intervention, delivered by telephone and email, in increasing the number of school canteens that have menus complying with a government healthy-canteen policy. Methods and analysis Seventy-two schools, across the Hunter New England Local Health District in New South Wales Australia, will be randomised to receive the multicomponent audit and feedback implementation intervention or usual support. The intervention will consist of between two and four canteen menu audits over 12 months. Each menu audit will be followed by two modes of feedback: a written feedback report and a verbal feedback/support via telephone. Primary outcomes, assessed by dieticians blind to group status and as recommended by the Fresh Tastes @ School policy, are: (1) the proportion of schools with a canteen menu containing foods or beverages restricted for sale, and; (2) the proportion of schools that have a menu which contains more than 50% of foods classified as healthy canteen items. Secondary outcomes are: the proportion of menu items in each category (‘red’, ‘amber’ and ‘green’), canteen profitability and cost-effectiveness. Ethics and dissemination Ethical approval has been obtained by from the Hunter New England Human Research Ethics Committee and the University of Newcastle Human Research Ethics Committee. The findings will be disseminated in usual forums, including peer

  17. Implementing intelligent physical exercise training at the workplace: health effects among office workers—a randomized controlled trial

    DEFF Research Database (Denmark)

    Dalager, Tina; Justesen, Just Bendix; Murray, Mike;

    2016-01-01

    Purpose: The aim was to assess 1-year cardiovascular health effects of Intelligent Physical Exercise Training, IPET. Methods: Office workers from six companies were randomized 1:1 to a training group, TG (N = 194) or a control group, CG (N = 195). TG received 1-h supervised high intensity IPET....... Conclusion: High intensity IPET combined with the recommendations of moderate intensity physical activity demonstrated significant clinical relevant improvements in CRF and systolic blood pressure. This underlines the effectiveness of health promotion by implementing physical exercise training...... every week within working hours for 1 year, and was recommended to perform 30-min of moderate intensity physical activity 6 days a week during leisure. The training program was based on baseline health check measures of cardiorespiratory fitness (CRF), body composition, blood pressure, blood profile...

  18. Implementation of an efficacious intervention for high risk women in Mexico: protocol for a multi-site randomized trial with a parallel study of organizational factors

    Directory of Open Access Journals (Sweden)

    Patterson Thomas L

    2012-10-01

    intervention will be analyzed, and across CBOs, correlations will be examined between individual and organizational provider characteristics and intervention efficacy. Discussion This cooperative, bi-national research study will provide critical insights into barriers and facilitating factors associated with implementing interventions in CBOs using the ‘train the trainer’ model. Our work builds on similar scale-up strategies that have been effective in the United States. This study has the potential to increase our knowledge of the generalizability of such strategies across health issues, national contexts, and organizational contexts. Trial registration NCT01465607

  19. The implementation of a community-based aerobic walking program for mild to moderate knee osteoarthritis: A knowledge translation randomized controlled trial: Part II: Clinical outcomes

    Directory of Open Access Journals (Sweden)

    Brosseau Lucie

    2012-12-01

    and other clinical outcomes. OA can be managed through the implementation of a proven effective walking program in existing community-based walking clubs. Trial registration Current Controlled Trials IRSCTNO9193542

  20. Making Self-Help More Helpful: A Randomized Controlled Trial of the Impact of Augmenting Self-Help Materials with Implementation Intentions on Promoting the Effective Self-Management of Anxiety Symptoms

    Science.gov (United States)

    Varley, Rachel; Webb, Thomas L.; Sheeran, Paschal

    2011-01-01

    Objective: The effectiveness of self-help materials may be constrained by failures to undertake recommended exercises or to deploy the techniques that one has learned at the critical moment. The present randomized controlled trial investigated whether augmenting self-help materials with if-then plans (or implementation intentions) could overcome…

  1. A full Bayes before-after study accounting for temporal and spatial effects: Evaluating the safety impact of new signal installations.

    Science.gov (United States)

    Sacchi, Emanuele; Sayed, Tarek; El-Basyouny, Karim

    2016-09-01

    Recently, important advances in road safety statistics have been brought about by methods able to address issues other than the choice of the best error structure for modeling crash data. In particular, accounting for spatial and temporal interdependence, i.e., the notion that the collision occurrence of a site or unit times depend on those of others, has become an important issue that needs further research. Overall, autoregressive models can be used for this purpose as they can specify that the output variable depends on its own previous values and on a stochastic term. Spatial effects have been investigated and applied mostly in the context of developing safety performance functions (SPFs) to relate crash occurrence to highway characteristics. Hence, there is a need for studies that attempt to estimate the effectiveness of safety countermeasures by including the spatial interdependence of road sites within the context of an observational before-after (BA) study. Moreover, the combination of temporal dynamics and spatial effects on crash frequency has not been explored in depth for SPF development. Therefore, the main goal of this research was to carry out a BA study accounting for spatial effects and temporal dynamics in evaluating the effectiveness of a road safety treatment. The countermeasure analyzed was the installation of traffic signals at unsignalized urban/suburban intersections in British Columbia (Canada). The full Bayes approach was selected as the statistical framework to develop the models. The results demonstrated that zone variation was a major component of total crash variability and that spatial effects were alleviated by clustering intersections together. Finally, the methodology used also allowed estimation of the treatment's effectiveness in the form of crash modification factors and functions with time trends. PMID:27249403

  2. Changes in primary care physician’s management of low back pain in a model of interprofessional collaborative care: an uncontrolled before-after study

    Directory of Open Access Journals (Sweden)

    Mior Silvano

    2013-02-01

    Full Text Available Abstract Background Tracking how clinicians treat patients provides an opportunity to explore how the clinical management of common musculoskeletal disorders evolves over time. We present an uncontrolled before-after study of a primary care physician’s management of low back pain and describe how his involvement in an interprofessional collaborative practice was associated with a change in the management of patients with low back pain. Method Data from the electronic medical record of one primary care physician who participated in a study of a model of chiropractic-medical collaboration were retrospectively collected. Records of a sample of consecutive patients prior to the start (i.e. pre-study, n = 51 and at the end of the collaborative study (i.e. study, n = 49 were collected. Results Demographics were similar in both groups but median number of physician visits (2.5 and 1.0, average prescriptions per patients (1.24 and 0.47, and total number of narcotic prescriptions (14 and 6 differed between pre-study and study groups, respectively. Separate analysis of only the records of low back pain study patients revealed that 61% were referred for chiropractic care during the study period. Patients who were not referred had more neurological deficits and leg pain but back pain severity and average number of prescriptions was about the same. Referred patients in the study group had about 25% fewer physician visits and imaging requests. Conclusion Based on this study of a single primary care physician, we hypothesize that doctors may change their prescribing behaviours and consultation rate for patients with low back pain when engaged in interprofessional collaborative care. Further research is required to test this observation in the population.

  3. Implementing knowledge into practice for improved neonatal survival; a cluster-randomised, community-based trial in Quang Ninh province, Vietnam

    Directory of Open Access Journals (Sweden)

    Huy Tran Q

    2011-09-01

    Full Text Available Abstract Background Globally, almost 4 million newborns die during the first 4 weeks of life every year. By increased use of evidence-based knowledge in the healthcare system a large proportion of these neonatal deaths could be prevented. But there is a severe lack of knowledge on effective methods for successful implementation of evidence into practice, particularly in low- and middle-income countries. Recent studies have demonstrated promising results with increased survival among both mothers and newborns using community-based approaches. In Vietnam evidence-based guidelines on reproductive health were launched in 2003 and revised in 2009. The overall objective of the current project is to evaluate if a facilitation intervention on the community level, with a problem-solving approach involving local representatives if the healthcare system and the community, results in improvements of neonatal health and survival. Methods/Design The study, which has been given the acronym NeoKIP (Neonatal Health - Knowledge Into Practice, took place in 8 districts composed by 90 communes in a province in northern Vietnam, where neonatal mortality rate was 24/1000 in 2005. A cluster randomised design was used, allocating clusters, as defined as a commune and its correponding Commune Health Center (CHC to either intervention or control arm. The facilitation intervention targeted staff at healthcare centres and key persons in the communes. The facilitator role was performed by lay women (Women's Union representatives using quality improvement techniques to initiate and sustain improvement processes targeting identified problem areas. The intervention has been running over 3 years and data were collected on the facilitation process, healthcare staff knowledge in neonatal care and their behaviour in clinical practice, and reproductive and perinatal health indicators. Primary outcome is neonatal mortality. Discussion The intervention is participatory and dynamic

  4. Implementation of case management to reduce cardiovascular disease risk in the Stanford and San Mateo Heart to Heart randomized controlled trial: study protocol and baseline characteristics

    Directory of Open Access Journals (Sweden)

    Stafford Randall S

    2006-09-01

    Full Text Available Abstract Background Case management has emerged as a promising alternative approach to supplement traditional one-on-one sessions between patients and doctors for improving the quality of care in chronic diseases such as coronary heart disease (CHD. However, data are lacking in terms of its efficacy and cost-effectiveness when implemented in ethnic and low-income populations. Methods The Stanford and San Mateo Heart to Heart (HTH project is a randomized controlled clinical trial designed to rigorously evaluate the efficacy and cost-effectiveness of a multi-risk cardiovascular case management program in low-income, primarily ethnic minority patients served by a local county health care system in California. Randomization occurred at the patient level. The primary outcome measure is the absolute CHD risk over 10 years. Secondary outcome measures include adherence to guidelines on CHD prevention practice. We documented the study design, methodology, and baseline sociodemographic, clinical and lifestyle characteristics of 419 participants. Results We achieved equal distributions of the sociodemographic, biophysical and lifestyle characteristics between the two randomization groups. HTH participants had a mean age of 56 years, 63% were Latinos/Hispanics, 65% female, 61% less educated, and 62% were not employed. Twenty percent of participants reported having a prior cardiovascular event. 10-year CHD risk averaged 18% in men and 13% in women despite a modest low-density lipoprotein cholesterol level and a high on-treatment percentage at baseline. Sixty-three percent of participants were diagnosed with diabetes and an additional 22% had metabolic syndrome. In addition, many participants had depressed high-density lipoprotein (HDL cholesterol levels and elevated values of total cholesterol-to-HDL ratio, triglycerides, triglyceride-to-HDL ratio, and blood pressure. Furthermore, nearly 70% of participants were obese, 45% had a family history of CHD or

  5. Using theories of behaviour to understand transfusion prescribing in three clinical contexts in two countries: Development work for an implementation trial

    Directory of Open Access Journals (Sweden)

    Brehaut Jamie C

    2009-10-01

    Full Text Available Abstract Background Blood transfusion is an essential part of healthcare and can improve patient outcomes. However, like most therapies, it is also associated with significant clinical risks. In addition, there is some evidence of overuse. Understanding the potential barriers and enablers to reduced prescribing of blood products will facilitate the selection of intervention components likely to be effective, thereby reducing the number of costly trials evaluating different implementation strategies. Using a theoretical basis to understand behaviours targeted for change will contribute to a 'basic science' relating to determinants of professional behaviour and how these inform the selection of techniques for changing behaviour. However, it is not clear which theories of behaviour are relevant to clinicians' transfusing behaviour. The aim of this study is to use a theoretical domains framework to identify relevant theories, and to use these theories to identify factors that predict the decision to transfuse. Methods The study involves two steps: interview study and questionnaire study. Using a previously identified framework, we will conduct semi-structured interviews with clinicians to elicit their views about which factors are associated with waiting and further monitoring the patient rather than transfusing red blood cells. Interviews will cover the following theoretical domains: knowledge; skills; social/professional role and identity; beliefs about capabilities; beliefs about consequences; motivation and goals; memory, attention, and decision processes; environmental context and resources; social influences; emotion; behavioural regulation; nature of the behaviour. The interviews will take place independently in Canada and the UK and involve two groups of physicians in each country (UK: adult and neonatal intensive care physicians; Canada: intensive care physicians and orthopaedic surgeons. We will: analyse interview transcript content to

  6. Effect of an Automated Training Presentation on Pre-Service Behavior Analysts' Implementation of Trial-Based Functional Analysis

    Science.gov (United States)

    Lambert, Joseph M.; Lloyd, Blair P.; Staubitz, Johanna L.; Weaver, Emily S.; Jennings, Chelsea M.

    2014-01-01

    The trial-based functional analysis (FA) is a useful alternative to the traditional FA in contexts in which it is challenging to establish environmental control for extended periods of time. Previous researchers have demonstrated that others can be trained to conduct trial-based FAs with high procedural fidelity by providing a didactic…

  7. Ensuring Treatment Fidelity in a Multi-site Behavioral Intervention Study: Implementing NIH Behavior Change Consortium Recommendations in the SMART Trial

    OpenAIRE

    Robb, Sheri L.; Burns, Debra S.; Docherty, Sharron L.; Haase, Joan E.

    2011-01-01

    The Stories and Music for Adolescent/Young Adult Resilience during Transplant (SMART) study (R01NR008583; U10CA098543; U10CA095861) is an ongoing multi-site Children’s Oncology Group randomized clinical trial testing the efficacy of a therapeutic music video intervention for adolescents/young adults (11–24 years of age) with cancer undergoing stem cell transplant. Treatment fidelity strategies from our trial are consistent with the NIH Behavior Change Consortium Treatment Fidelity Workgroup (...

  8. Barriers to the implementation of mobile phone reminders in pediatric HIV care: a pre-trial analysis of the Cameroonian MORE CARE study

    OpenAIRE

    Bigna, Jean Joel R; Jean Jacques N Noubiap; Plottel, Claudia S; Kouanfack, Charles; Koulla-Shiro, Sinata

    2014-01-01

    Background Mobile health (mhealth) has emerged as a powerful resource in the medical armamentarium against human immunodeficiency virus (HIV) infection. We sought to determine among adult caregivers of HIV-exposed/infected children; the extent of mobile phone ownership, the ability to communicate in Cameroon’s national official languages (NOL), and the refusal to receive such reminders. Methods We conducted a pre-trial analysis of potentials participants of the MORE CARE trial. MORE CARE took...

  9. Adherence of non-pharmaceutically sponsored oncology trial protocols to the International Conference on Harmonization (ICH) guidelines in an academic institution outside the ICH jurisdictions and the impact of IRB implementation on this adherence

    International Nuclear Information System (INIS)

    Purpose: To assess adherence of non-pharmaceutically sponsored trials (non-PSTs) to ICH protocol structure guidelines and to estimate the effect of implementing Institutional Review Boards (IRB) review on this adherence. Methods: This is a retrospective exploratory study where 60 non-PST clinical trial protocols (CTPs) were reviewed and halved to IRB-reviewed CTPs (IRCTPs) and non-lRB-reviewed CTPs (non-lRCTPs). Adherence score (AS) was calculated as the number of fulfilled items or sub-items divided by their total number. Results: Three adherence patterns were encountered: (1) items consistently present in both groups e.g. general and background information, objectives, inclusion criteria and intervention details, (2) items consistently absent in both groups and included contact information of investigators and trial sites, product accountability, randomization codes management, interim analyses and many other statistical aspects, and (3) items variably present in both groups where the effect of IRB was verifiable. Trial site details, potential benefits, discontinuation and exclusion criteria, and follow up for adverse events were more encountered in IRCTPs than non-IRCTPs. Withdrawal criteria monitoring of treatment compliance showed a reverse pattern (p < 0.05 for all). The total AS, administrative AS and ethics AS for IRCTPs was 43%, 22% and 70% compared to 38%, 16% and 33% for non-IRCTPs (p < 0.003, <0.001, 0.004), respectively. The scientific AS was 54% for both groups (p = 0.87). Conclusions: IRB-implementation at NCl-Egypt improved ethical and administrative sections of academic protocols. However, this improvement is modest and needs further actions including adoption of protocol templates. Scientific sections were as good after IRB-implementation as they were before that

  10. Treatment of Internet Addiction with Anxiety Disorders: Treatment Protocol and Preliminary Before-After Results Involving Pharmacotherapy and Modified Cognitive Behavioral Therapy

    Science.gov (United States)

    Santos, Hugo Henrique

    2016-01-01

    Background The growth of the Internet has led to significant change and has become an integral part of modern life. It has made life easier and provided innumerous benefits; however, excessive use has brought about the potential for addiction, leading to severe impairments in social, academic, financial, psychological, and work domains. Individuals addicted to the Internet usually have comorbid psychiatric disorders. Panic disorder (PD) and generalized anxiety disorder (GAD) are prevalent mental disorders, involving a great deal of damage in the patient’s life. Objective This open trial study describes a treatment protocol among 39 patients with anxiety disorders and Internet addiction (IA) involving pharmacotherapy and modified cognitive behavioral therapy (CBT). Methods Of the 39 patients, 25 were diagnosed with PD and 14 with GAD, in addition to Internet addiction. At screening, patients responded to the MINI 5.0, Hamilton Anxiety Rating Scale, Hamilton Depression Rating Scale, Clinical Global Impressions Scale, and the Young Internet Addiction Scale. At that time, IA was observed taking into consideration the IAT scale (cutoff score above 50), while anxiety disorders were diagnosed by a psychiatrist. Patients were forwarded for pharmacotherapy and a modified CBT protocol. Psychotherapy was conducted individually, once a week, over a period of 10 weeks, and results suggest that the treatment was effective for anxiety and Internet addiction. Results Before treatment, anxiety levels suggested severe anxiety, with an average score of 34.26 (SD 6.13); however, after treatment the mean score was 15.03 (SD 3.88) (PInternet addiction scores was observed, from 67.67 (SD 7.69) before treatment, showing problematic internet use, to 37.56 (SD 9.32) after treatment (PInternet use. With respect to the relationship between IA and anxiety, the correlation between scores was .724. Conclusions This study is the first research into IA treatment of a Brazilian population. The

  11. Understanding Patient Values and the Manifestations in Clinical Research with Traditional Chinese Medicine—With Practical Suggestions for Trial Design and Implementation

    Directory of Open Access Journals (Sweden)

    Wei Mu

    2013-01-01

    Full Text Available Objective. To define patient values, identify their manifestations in a randomized clinical trial, and investigate the possible implications for clinical research of traditional Chinese medicine. Methods. We categorized patient values manifestations into patient choice, preference, compliance, and patient-reported outcomes and summarized the underlying personal values through purposeful electronic searches for relevant reports. By hypothesizing a set of positive versus negative circumstances occurring in the enrollment, intervention allocation, treatment, and the follow-up stage of a trial, it is possible to discuss the potential implications of patient values manifestation on a trial with traditional Chinese medicine. Results. Patient values and its manifestations are ubiquitous in the process of clinical research with traditional Chinese medicine. These values may provide motivation for participation or engender the internal and external validity of the study. Conclusions. Trialists should attach sufficient importance to the needs and concerns of individual participant. To incorporate patient values into the design and conduct of a clinical study with traditional Chinese medicine, researchers are recommended to adopt participant-friendly design and use patient-reported outcomes, take convenience-for-patients measures, and help foster rational beliefs and behaviors of trial participants.

  12. Exploring the variation in implementation of a COPD disease management programme and its impact on health outcomes: a post hoc analysis of the RECODE cluster randomised trial.

    Science.gov (United States)

    Boland, Melinde R S; Kruis, Annemarije L; Huygens, Simone A; Tsiachristas, Apostolos; Assendelft, Willem J J; Gussekloo, Jacobijn; Blom, Coert M G; Chavannes, Niels H; Rutten-van Mölken, Maureen P M H

    2015-01-01

    This study aims to (1) examine the variation in implementation of a 2-year chronic obstructive pulmonary disease (COPD) management programme called RECODE, (2) analyse the facilitators and barriers to implementation and (3) investigate the influence of this variation on health outcomes. Implementation variation among the 20 primary-care teams was measured directly using a self-developed scale and indirectly through the level of care integration as measured with the Patient Assessment of Chronic Illness Care (PACIC) and the Assessment of Chronic Illness Care (ACIC). Interviews were held to obtain detailed information regarding the facilitators and barriers to implementation. Multilevel models were used to investigate the association between variation in implementation and change in outcomes. The teams implemented, on average, eight of the 19 interventions, and the specific package of interventions varied widely. Important barriers and facilitators of implementation were (in)sufficient motivation of healthcare provider and patient, the high starting level of COPD care, the small size of the COPD population per team, the mild COPD population, practicalities of the information and communication technology (ICT) system, and hurdles in reimbursement. Level of implementation as measured with our own scale and the ACIC was not associated with health outcomes. A higher level of implementation measured with the PACIC was positively associated with improved self-management capabilities, but this association was not found for other outcomes. There was a wide variety in the implementation of RECODE, associated with barriers at individual, social, organisational and societal level. There was little association between extent of implementation and health outcomes. PMID:26677770

  13. The effect of complete integration of HIV and TB services on time to initiation of antiretroviral therapy: a before-after study.

    Directory of Open Access Journals (Sweden)

    Bernhard Kerschberger

    Full Text Available BACKGROUND: Studies have shown that early ART initiation in TB/HIV co-infected patients lowers mortality. One way to implement earlier ART commencement could be through integration of TB and HIV services, a more efficient model of care than separate, vertical programs. We present a model of full TB/HIV integration and estimate its effect on time to initiation of ART. METHODOLOGY/PRINCIPAL FINDINGS: We retrospectively reviewed TB registers and clinical notes of 209 TB/HIV co-infected adults with a CD4 count <250 cells/µl and registered for TB treatment at one primary care clinic in a South African township between June 2008 and May 2009. Using Kaplan-Meier and Cox proportional hazard analysis, we compared time between initiation of TB treatment and ART for the periods before and after full, "one-stop shop" integration of TB and HIV services (in December 2009. Potential confounders were determined a priori through directed acyclic graphs. Robustness of assumptions was investigated by sensitivity analyses. The analysis included 188 patients (100 pre- and 88 post-integration, yielding 56 person-years of observation. Baseline characteristics of the two groups were similar. Median time to ART initiation decreased from 147 days (95% confidence interval [CI] 85-188 before integration of services to 75 days (95% CI 52-119 post-integration. In adjusted analyses, patients attending the clinic post-integration were 1.60 times (95% CI 1.11-2.29 more likely to have started ART relative to the pre-integration period. Sensitivity analyses supported these findings. CONCLUSIONS/SIGNIFICANCE: Full TB/HIV care integration is feasible and led to a 60% increased chance of co-infected patients starting ART, while reducing time to ART initiation by an average of 72 days. Although these estimates should be confirmed through larger studies, they suggest that scale-up of full TB/HIV service integration in high TB/HIV prevalence settings may shorten time to ART initiation

  14. Feasibility and Impact of Doctor-Nurse Task Delegation in Preventive Child Health Care in the Netherlands, a Controlled Before-After Study.

    Directory of Open Access Journals (Sweden)

    S Janine Benjamins

    experienced an equal level of proficiency but less continuity in person.This experiment shows that task delegation from doctor to nurse in preventive child health care is feasible. It is important to pay attention to the acceptation process of professionals during implementation. More investigation is needed in order to assess effectiveness and efficacy of task delegation.

  15. Effectiveness of an intervention in increasing the provision of preventive care by community mental health services: a non-randomized, multiple baseline implementation trial

    OpenAIRE

    Bartlem, Kate M.; Bowman, Jenny; Freund, Megan; Wye, Paula M.; Barker, Daniel; McElwaine, Kathleen M; Wolfenden, Luke; Campbell, Elizabeth M.; McElduff, Patrick; Gillham, Karen; Wiggers, John

    2016-01-01

    Background Relative to the general population, people with a mental illness are more likely to have modifiable chronic disease health risk behaviours. Care to reduce such risks is not routinely provided by community mental health clinicians. This study aimed to determine the effectiveness of an intervention in increasing the provision of preventive care by such clinicians addressing four chronic disease risk behaviours. Methods A multiple baseline trial was undertaken in two groups of communi...

  16. Hands4U: A multifaceted strategy to implement guideline-based recommendations to prevent hand eczema in health care workers: design of a randomised controlled trial and (cost effectiveness evaluation

    Directory of Open Access Journals (Sweden)

    van der Gulden Joost W

    2011-08-01

    Full Text Available Abstract Background Workers in wet work occupations have a risk for developing hand eczema. Prevention strategies exist, but compliance to the proposed recommendations is poor. Therefore, a multifaceted implementation strategy (MIS is developed to implement these recommendations to reduce hand eczema among health care workers performing wet work. Methods/Design This study is a randomised controlled trial in three university hospitals in the Netherlands. Randomisation to the control or intervention group is performed at department level. The control group receives a leaflet containing the recommendations only. The intervention group receives the MIS which consists of five parts: 1 within a department, a participatory working group is formed to identify problems with the implementation of the recommendations, to find solutions for it and implement these solutions; 2 role models will help their colleagues in performing the desired behaviour; 3 education to all workers will enhance knowledge about (the prevention of hand eczema; 4 reminders will be placed at the department reminding workers to use the recommendations; 5 workers receive the same leaflet as the control group containing the recommendations. Data are collected by questionnaires at baseline and after 3, 6, 9 and 12 months. The primary outcome measure is self-reported hand eczema. The most important secondary outcome measures are symptoms of hand eczema; actual use of the recommendations; sick leave; work productivity; and health care costs. Analyses will be performed according to the intention to treat principle. Cost-effectiveness of the MIS will be evaluated from both the societal and the employer's perspective. Discussion The prevention of hand eczema is important for the hospital environment. If the MIS has proven to be effective, a major improvement in the health of health care workers can be obtained. Results are expected in 2014. Trial registration number NTR2812

  17. Long-Term Clinical Outcomes from a Randomized Controlled Trial of Two Implementation Strategies to Promote Collaborative Care Attendance in Community Practices.

    Science.gov (United States)

    Kilbourne, Amy M; Goodrich, David E; Nord, Kristina M; Van Poppelen, Celeste; Kyle, Julia; Bauer, Mark S; Waxmonsky, Jeanette A; Lai, Zongshan; Kim, Hyungjin M; Eisenberg, Daniel; Thomas, Marshall R

    2015-09-01

    This randomized controlled implementation study compared the effectiveness of a standard versus enhanced version of the replicating effective programs (REP) implementation strategy to improve the uptake of the life goals-collaborative care model (LG-CC) for bipolar disorder. Seven community-based practices (384 patient participants) were randomized to standard (manual/training) or enhanced REP (customized manual/training/facilitation) to promote LG-CC implementation. Participants from enhanced REP sites had no significant changes in primary outcomes (improved quality of life, reduced functioning or mood symptoms) by 24 months. Further research is needed to determine whether implementation strategies can lead to sustained, improved participant outcomes in addition to program uptake. PMID:25315181

  18. Implementation of a pharmacist-led intervention to enhance statin prescribing for secondary prevention in primary care: a cluster randomized trial.

    NARCIS (Netherlands)

    Steeg-van Gompel, C.H.P.A. van de; Wensing, M.J.; Smet, P.A.G.M. de

    2012-01-01

    BACKGROUND: Although statins have indisputably proven to reduce fatal and nonfatal events in patients with cardiovascular disease, many patients with established cardiovascular disease do not receive them. Research into the effective and efficient implementation of current guidelines on secondary pr

  19. An intervention to improve program implementation: findings from a two-year cluster randomized trial of Assets-Getting To Outcomes

    OpenAIRE

    Acosta, Joie; Chinman, Matthew; Ebener, Patricia; Malone, Patrick S.; Paddock, Susan; Phillips, Andrea; Scales, Peter; Slaughter, Mary Ellen

    2013-01-01

    Background Studies have shown that communities have not always been able to implement evidence-based prevention programs with quality and achieve outcomes demonstrated by prevention science. Implementation support interventions are needed to bridge this gap between science and practice. The purpose of this article is to present two-year outcomes from an evaluation of the Assets Getting To Outcomes (AGTO) intervention in 12 Maine communities engaged in promoting Developmental Assets, a positiv...

  20. Implementing evidence-based recommended practices for the management of patients with mild traumatic brain injuries in Australian emergency care departments: study protocol for a cluster randomised controlled trial

    Science.gov (United States)

    2014-01-01

    Background Mild head injuries commonly present to emergency departments. The challenges facing clinicians in emergency departments include identifying which patients have traumatic brain injury, and which patients can safely be sent home. Traumatic brain injuries may exist with subtle symptoms or signs, but can still lead to adverse outcomes. Despite the existence of several high quality clinical practice guidelines, internationally and in Australia, research shows inconsistent implementation of these recommendations. The aim of this trial is to test the effectiveness of a targeted, theory- and evidence-informed implementation intervention to increase the uptake of three key clinical recommendations regarding the emergency department management of adult patients (18 years of age or older) who present following mild head injuries (concussion), compared with passive dissemination of these recommendations. The primary objective is to establish whether the intervention is effective in increasing the percentage of patients for which appropriate post-traumatic amnesia screening is performed. Methods/design The design of this study is a cluster randomised trial. We aim to include 34 Australian 24-hour emergency departments, which will be randomised to an intervention or control group. Control group departments will receive a copy of the most recent Australian evidence-based clinical practice guideline on the acute management of patients with mild head injuries. The intervention group will receive an implementation intervention based on an analysis of influencing factors, which include local stakeholder meetings, identification of nursing and medical opinion leaders in each site, a train-the-trainer day and standardised education and interactive workshops delivered by the opinion leaders during a 3 month period of time. Clinical practice outcomes will be collected retrospectively from medical records by independent chart auditors over the 2 month period following

  1. Rationale, design, and implementation protocol of an electronic health record integrated clinical prediction rule (iCPR randomized trial in primary care

    Directory of Open Access Journals (Sweden)

    Wisnivesky Juan

    2011-09-01

    Full Text Available Abstract Background Clinical prediction rules (CPRs represent well-validated but underutilized evidence-based medicine tools at the point-of-care. To date, an inability to integrate these rules into an electronic health record (EHR has been a major limitation and we are not aware of a study demonstrating the use of CPR's in an ambulatory EHR setting. The integrated clinical prediction rule (iCPR trial integrates two CPR's in an EHR and assesses both the usability and the effect on evidence-based practice in the primary care setting. Methods A multi-disciplinary design team was assembled to develop a prototype iCPR for validated streptococcal pharyngitis and bacterial pneumonia CPRs. The iCPR tool was built as an active Clinical Decision Support (CDS tool that can be triggered by user action during typical workflow. Using the EHR CDS toolkit, the iCPR risk score calculator was linked to tailored ordered sets, documentation, and patient instructions. The team subsequently conducted two levels of 'real world' usability testing with eight providers per group. Usability data were used to refine and create a production tool. Participating primary care providers (n = 149 were randomized and intervention providers were trained in the use of the new iCPR tool. Rates of iCPR tool triggering in the intervention and control (simulated groups are monitored and subsequent use of the various components of the iCPR tool among intervention encounters is also tracked. The primary outcome is the difference in antibiotic prescribing rates (strep and pneumonia iCPR's encounters and chest x-rays (pneumonia iCPR only between intervention and control providers. Discussion Using iterative usability testing and development paired with provider training, the iCPR CDS tool leverages user-centered design principles to overcome pervasive underutilization of EBM and support evidence-based practice at the point-of-care. The ongoing trial will determine if this collaborative

  2. Before, after, in and beyond Teacher Education

    Science.gov (United States)

    Garrett, H. James

    2013-01-01

    The author uses a trip to a Holocaust museum to explain and illustrate psychoanalytic concepts from Freud to Lacan in order to re-imagine persistent dilemmas in teacher education. The author suggests that psychoanalytic vocabularies provide an additional and productive lens to conceptualize productive possibilities in teacher education.

  3. Before & After of Rasping on Sol 56

    Science.gov (United States)

    2008-01-01

    This animation combines two images of the trench informally named 'Snow White' taken by the Surface Stereo Imager on NASA's Phoenix Mars Lander on July 21, 2008, during the lander's 56th Martian day, or sol, since landing. The earlier Sol 56 image is the one without a shadow falling across the lower right corner of the image. It was taken after Phoenix had used its motorized rasp to get some material from the trench into the scoop on the lander's robotic arm. The later Sol 56 image was taken after the arm had scraped clean an area that includes the rasping site. The trench is about 23 centimeters (9 inches) wide. These images were taken through the camera's red filter. The Phoenix Mission is led by the University of Arizona, Tucson, on behalf of NASA. Project management of the mission is led by NASA's Jet Propulsion Laboratory, Pasadena, Calif. Spacecraft development is by Lockheed Martin Space Systems, Denver.

  4. Rationale, design, and implementation protocol of the Dutch clinical practice guideline Pain in patients with cancer: a cluster randomised controlled trial with short message service (SMS and interactive voice response (IVR

    Directory of Open Access Journals (Sweden)

    te Boveldt Nienke

    2011-12-01

    Full Text Available Abstract Background One-half of patients with cancer have pain. In nearly one out of two cancer patients with pain, this was undertreated. Inadequate pain control still remains an important problem in this group of patients. Therefore, in 2008 a national, evidence-based multidisciplinary clinical practice guideline 'pain in patients with cancer' has been developed. Yet, publishing a guideline is not enough. Implementation is needed to improve pain management. An innovative implementation strategy, Short Message Service with Interactive Voice Response (SVS-IVR, has been developed and pilot tested. This study aims to evaluate on effectiveness of this strategy to improve pain reporting, pain measurement and adequate pain therapy. In addition, whether the active role of the patient and involvement of caregivers in pain management may change. Methods/design A cluster randomised controlled trial with two arms will be performed in six oncology outpatient clinics of hospitals in the Southeastern region of the Netherlands, with three hospitals in the intervention and three in the control condition. Follow-up measurements will be conducted in all hospitals to study the long-term effect of the intervention. The intervention includes training of professionals (medical oncologists, nurses, and general practitioners and SMS-IVR to report pain in patients with cancer to improve pain reporting by patients, pain management by medical oncologists, nurses, and general practitioners, and decrease pain intensity. Discussion This innovative implementation strategy with technical tools and the involvement of patients, may enhance the use of the guideline 'pain in patients with cancer' for pain management. Short Message Service alerts may serve as a tool to support self-management of patients. Therefore, the SMS-IVR intervention may increase the feeling of having control over one's life. Trail registration Netherlands Trial Register (NTR: NTR2739

  5. Effectiveness of supervised implementation of an oral health care guideline in care homes; a single-blinded cluster randomized controlled trial

    NARCIS (Netherlands)

    Putten, G.J. van der; Mulder, J.; Baat, C. de; De Visschere, L.M.; Vanobbergen, J.N.; Schols, J.M.

    2013-01-01

    OBJECTIVES: The objective of this study was to assess the effectiveness of a supervised implementation of the "Oral health care Guideline for Older people in Long-term care Institutions" (OGOLI) in The Netherlands. MATERIALS AND METHODS: A sample of 12 care homes in the Netherlands was allocated ran

  6. Implementation Intentions as a Strategy to Increase the Notification Rate of Potential Ocular Tissue Donors by Nurses: A Clustered Randomized Trial in Hospital Settings

    Directory of Open Access Journals (Sweden)

    Frédéric Douville

    2014-01-01

    Full Text Available Aim. The purpose of this study is to evaluate the impact, among nurses in hospital settings, of a questionnaire-based implementation intentions intervention on notification of potential ocular tissue donors to donation stakeholders. Methods. This randomized intervention was clustered at the level of hospital departments with two study arms: questionnaire-based implementation intentions intervention and control. In the intervention group, nurses were asked to plan specific actions if faced with a number of barriers when reporting potential ocular donors. The primary outcome was the potential ocular tissue donors’ notification rate before and after the intervention. Analysis was based on a generalized linear model with an identity link and a binomial distribution. Results. We compared outcomes in 26 departments from 5 hospitals, 13 departments per condition. The implementation intentions intervention did not significantly increase the notification rate of ocular tissue donors (intervention: 23.1% versus control: 21.1%; χ2=1.14, 2; P=0.56. Conclusion. A single and brief implementation intentions intervention among nurses did not modify the notification rate of potential ocular tissue donors to donation stakeholders. Low exposure to the intervention was a major challenge in this study. Further studies should carefully consider a multicomponent intervention to increase exposure to this type of intervention.

  7. Implementation of outpatient schema therapy for borderline personality disorder with versus without crisis support by the therapist outside office hours : A randomized trial

    NARCIS (Netherlands)

    Nadort, Marjon; Arntz, Arnoud; Smit, Johannes H; Giesen-Bloo, Josephine; Eikelenboom, Merijn; Spinhoven, Philip; van Asselt, Thea; Wensing, Michel; van Dyck, Richard

    2009-01-01

    OBJECTIVE: This study aimed to evaluate the success of implementing outpatient schema focused therapy (ST) for borderline patients in regular mental healthcare and to determine the added value of therapist telephone availability outside office hours in case of crisis (TTA). METHODS: To enhance the i

  8. Implementation of Internet-based preventive interventions for depression and anxiety: role of support? The design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Marks Isaac

    2009-07-01

    Full Text Available Abstract Background Internet-based self-help is an effective preventive intervention for highly prevalent disorders, such as depression and anxiety. It is not clear, however, whether it is necessary to offer these interventions with professional support or if they work without any guidance. In case support is necessary, it is not clear which level of support is needed. This study examines whether an internet-based self-help intervention with a coach is more effective than the same intervention without a coach in terms of clinical outcomes, drop-out and economic costs. Moreover, we will investigate which level of support by a coach is more effective compared to other levels of support. Methods In this randomized controlled trial, a total of 500 subjects (18 year and older from the general population with mild to moderate depression and/or anxiety will be assigned to one of five conditions: (1 web-based problem solving through the internet (self-examination therapy without a coach; (2 the same as 1, but with the possibility to ask help from a coach on the initiative of the respondent (on demand, by email; (3 the same as 1, but with weekly scheduled contacts initiated by a coach (once per week, by email; (4 weekly scheduled contacts initiated by a coach, but no web-based intervention; (5 information only (through the internet. The interventions will consist of five weekly lessons. Primary outcome measures are symptoms of depression and anxiety. Secondary outcome measures are drop-out from the intervention, quality of life, and economic costs. Other secondary outcome measures that may predict outcome are also studied, e.g. client satisfaction and problem-solving skills. Measures are taken at baseline (pre-test, directly after the intervention (post-test, five weeks after baseline, 3 months later, and 12 months later. Analysis will be conducted on the intention-to-treat sample. Discussion This study aims to provide more insight into the clinical

  9. The European quality of care pathways (EQCP study on the impact of care pathways on interprofessional teamwork in an acute hospital setting: study protocol: for a cluster randomised controlled trial and evaluation of implementation processes

    Directory of Open Access Journals (Sweden)

    Deneckere Svin

    2012-05-01

    Full Text Available Abstract Background Although care pathways are often said to promote teamwork, high-level evidence that supports this statement is lacking. Furthermore, knowledge on conditions and facilitators for successful pathway implementation is scarce. The objective of the European Quality of Care Pathway (EQCP study is therefore to study the impact of care pathways on interprofessional teamwork and to build up understanding on the implementation process. Methods/design An international post-test-only cluster Randomised Controlled Trial (cRCT, combined with process evaluations, will be performed in Belgium, Ireland, Italy, and Portugal. Teams caring for proximal femur fracture (PFF patients and patients hospitalized with an exacerbation of chronic obstructive pulmonary disease (COPD will be randomised into an intervention and control group. The intervention group will implement a care pathway for PFF or COPD containing three active components: a formative evaluation of the actual teams’ performance, a set of evidence-based key interventions, and a training in care pathway-development. The control group will provide usual care. A set of team input, process and output indicators will be used as effect measures. The main outcome indicator will be relational coordination. Next to these, process measures during and after pathway development will be used to evaluate the implementation processes. In total, 132 teams have agreed to participate, of which 68 were randomly assigned to the intervention group and 64 to the control group. Based on power analysis, a sample of 475 team members per arm is required. To analyze results, multilevel analysis will be performed. Discussion Results from our study will enhance understanding on the active components of care pathways. Through this, preferred implementation strategies can be defined. Trail registration NCT01435538

  10. Increase in EPI vaccines coverage after implementation of intermittent preventive treatment of malaria in infant with Sulfadoxine -pyrimethamine in the district of Kolokani, Mali: Results from a cluster randomized control trial

    Directory of Open Access Journals (Sweden)

    Salomon Roger

    2011-07-01

    Full Text Available Abstract Background Even though the efficacy of Intermittent Preventive Treatment in infants (IPTi with Sulfadoxine-Pyrimethamine (SP against clinical disease and the absence of its interaction with routine vaccines of the Expanded Immunization Programme (EPI have been established, there are still some concerns regarding the addition of IPTi, which may increase the work burden and disrupt the routine EPI services especially in Africa where the target immunization coverage remains to be met. However IPTi may also increase the adherence of the community to EPI services and improve EPI coverage, once the benefice of strategy is perceived. Methods To assess the impact of IPTi implementation on the coverage of EPI vaccines, 22 health areas of the district of Kolokani were randomized at a 1:1 ratio to either receive IPTi-SP or to serve as a control. The EPI vaccines coverage was assessed using cross-sectional surveys at baseline in November 2006 and after one year of IPTi pilot-implementation in December 2007. Results At baseline, the proportion of children of 9-23 months who were completely vaccinated (defined as children who received BGG, 3 doses of DTP/Polio, measles and yellow fever vaccines was 36.7% (95% CI 25.3% -48.0%. After one year of implementation of IPTi-SP using routine health services, the proportion of children completely vaccinated rose to 53.8% in the non intervention zone and 69.5% in the IPTi intervention zone (P The proportion of children in the target age groups who received IPTi with each of the 3 vaccinations DTP2, DTP3 and Measles, were 89.2% (95% CI 85.9%-92.0%, 91.0% (95% CI 87.6% -93.7% and 77.4% (95% CI 70.7%-83.2% respectively. The corresponding figures in non intervention zone were 2.3% (95% CI 0.9% -4.7%, 2.6% (95% CI 1.0% -5.6% and 1.7% (95% CI 0.4% - 4.9%. Conclusion This study shows that high coverage of the IPTi can be obtained when the strategy is implemented using routine health services and implementation results

  11. Using community engagement to inform and implement a community-randomized controlled trial in the Anishinaabek Cervical Cancer Screening Study (ACCSS

    Directory of Open Access Journals (Sweden)

    Brianne eWood

    2014-02-01

    Full Text Available Social, political, and economic factors are directly and indirectly associated with the quality and distribution of health resources across Canada. First Nations (FN women in particular endure a disproportionate burden of ill health in contrast to the mainstream population. The complex relationship of health, social, and historical determinants are inherent to increased cervical cancer in FN women. This can be traced back to the colonial oppression suffered by Canadian FN and the social inequalities they have since faced. Screening - the Papinacolaou (Pap test – and early immunization have rendered cervical cancer almost entirely preventable but despite these options, FN women endure notably higher rates of diagnosis and mortality due to cervical cancer. The Anishinaabek Cervical Cancer Screening Study (ACCSS is a participatory action research project investigating the factors underlying the cervical cancer burden in FN women. ACCSS is a collaboration with 11 FN communities in Northwest Ontario, Canada and a multidisciplinary research team from across Canada with expertise in cancer biology, epidemiology, medical anthropology, public health, virology, women’s health, and pathology. Interviews with healthcare providers and community members revealed that prior to any formal data collection education must be offered. Consequently, an educational component was integrated into the existing quantitative design of the study: a two-armed, community-randomized trial that compares the uptake of two different cervical screening modalities. In ACCSS, the Research Team integrates community engagement and the flexible nature of participatory research with the scientific rigor of a randomized controlled trial. ACCSS findings will inform culturally appropriate screening strategies, aiming to reduce the disproportionate burden of cervical disease in concert with priorities of the partner FN communities.

  12. Nurse-led motivational interviewing to change the lifestyle of patients with type 2 diabetes (MILD-project: protocol for a cluster, randomized, controlled trial on implementing lifestyle recommendations

    Directory of Open Access Journals (Sweden)

    Niessen Louis

    2009-01-01

    Full Text Available Abstract Background The diabetes of many patients is managed in general practice; healthcare providers aim to promote healthful behaviors, such as healthful diet, adequate physical activity, and smoking cessation. These measures may decrease insulin resistance, improve glycemic control, lipid abnormalities, and hypertension. They may also prevent cardiovascular disease and complications of diabetes. However, professionals do not adhere optimally to guidelines for lifestyle counseling. Motivational interviewing to change the lifestyle of patients with type 2 diabetes is intended to improve diabetes care in accordance with the national guidelines for lifestyle counseling. Primary care nurses will be trained in motivational interviewing embedded in structured care in general practice. The aim of this paper is to describe the design and methods of a study evaluating the effects of the nurses' training on patient outcomes. Methods/Design A cluster, randomized, controlled trial involving 70 general practices (35 practices in the intervention arm and 35 in the control arm starting in March 2007. A total of 700 patients with type 2 diabetes will be recruited. The patients in the intervention arm will receive care from the primary care nurse, who will receive training in an implementation strategy with motivational interviewing as the core component. Other components of this strategy will be adaptation of the diabetes protocol to local circumstances, introduction of a social map for lifestyle support, and educational and supportive tools for sustaining motivational interviewing. The control arm will be encouraged to maintain usual care. The effect measures will be the care process, metabolic parameters (glycosylated hemoglobin, blood pressure and lipids, lifestyle (diet, physical activity, smoking, and alcohol, health-related quality of life, and patients' willingness to change behaviors. The measurements will take place at baseline and after 14 months

  13. COSMOS-improving the quality of life in nursing home patients: Protocol for an effectiveness-implementation cluster randomized clinical hybrid trial

    OpenAIRE

    Husebø, Bettina; Flo, Elisabeth; Aarsland, Dag; Selbæk, Geir; Testad, Ingelin; Gulla, Christine; Aasmul, Irene; Ballard, Clive

    2015-01-01

    Background Nursing home patients have complex mental and physical health problems, disabilities and social needs, combined with widespread prescription of psychotropic drugs. Preservation of their quality of life is an important goal. This can only be achieved within nursing homes that offer competent clinical conditions of treatment and care. COmmunication, Systematic assessment and treatment of pain, Medication review, Occupational therapy, Safety (COSMOS) is an effectiveness-implementation...

  14. Effect of home-based counselling on newborn care practices in southern Tanzania one year after implementation: a cluster-randomised controlled trial

    OpenAIRE

    Penfold, S.; Manzi, F.; Mkumbo, E; Temu, S; Jaribu, J.; Shamba, DD; Mshinda, H; Cousens, S.; Marchant, T; Tanner, M; Schellenberg, D; Armstrong Schellenberg, J

    2014-01-01

    BACKGROUND In Sub-Saharan Africa over one million newborns die annually. We developed a sustainable and scalable home-based counselling intervention for delivery by community volunteers in rural southern Tanzania to improve newborn care practices and survival. Here we report the effect on newborn care practices one year after full implementation. METHODS All 132 wards in the 6-district study area were randomised to intervention or comparison groups. Starting in 2010, in intervention area...

  15. Conduct problems in children. Characteristics of families recruited for a clinical outcome trial as compared to families in an implementation study

    OpenAIRE

    Solholm, Roar; Ogden, Terje; Jakobsen, Reidar

    2014-01-01

    The implementation of empirically supported treatments (EST) is recommended as a way to transfer knowledge fromresearch to clinical practice and to improve service quality. One area of concern has been client representativeness, that is to which degree participants in EST studies resembles the target group in usual care settings. For childrenwith conduct problems the recommended ESTs have been parent training or parentmediated programs. The aimof this article is to explore and des...

  16. Clinical Trials

    Science.gov (United States)

    Clinical trials are research studies that test how well new medical approaches work in people. Each study answers ... prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a ...

  17. Stroke Trials Registry

    Science.gov (United States)

    ... News About Neurology Image Library Search The Internet Stroke Center Trials Registry Clinical Trials Interventions Conditions Sponsors ... a clinical trial near you Welcome to the Stroke Trials Registry Our registry of clinical trials in ...

  18. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... treatment, screening, diagnostic, prevention, and supportive care trials. Treatment Trials In treatment trials, researchers may gather information about experimental treatments, ...

  19. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Emery, C. A.; Roos, Ewa M.; Verhagen, E.; Finch, C. F.; Bennell, K. L.; Story, B.; Spindler, K.; Kemp, J.; Lohmander, L. S.

    2015-01-01

    The risk of post-traumatic osteoarthritis (PTOA) substantially increases following joint injury. Research efforts should focus on investigating the efficacy of preventative strategies in high quality randomized controlled trials (RCT). The objective of these OARSI RCT recommendations is to inform...... regarding the research question, research design, study participants, randomization, baseline characteristics, intervention, outcome measurement, analysis, implementation, cost evaluation, reporting and future considerations including the impact on development of PTOA. Methodological recommendations for...... will facilitate between study comparisons to inform best practice in injury prevention that will have the greatest public health impact....

  20. Participating in Clinical Trials

    Medline Plus

    Full Text Available Home > Health topics A-Z > Participating in Clinical Trials: About Clinical Trials In This Topic About Clinical Trials Risks ... centers across the country. The National Institutes of Health funds much of this basic research. Screening Trials ...

  1. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Usually, trial participants must show signs of the disease or condition before they can join this type of trial. Prevention Trials Click for more information In prevention trials, ...

  2. Pilot implementation

    DEFF Research Database (Denmark)

    Hertzum, Morten; Bansler, Jørgen P.; Havn, Erling C.;

    2012-01-01

    difficult to plan and conduct. It is sometimes assumed that pilot implementations are less complicated and risky than ordinary implementations. Pilot implementations are, however, neither prototyping nor small-scale versions of full-scale implementations; they are fundamentally different and have their own...

  3. Pilot implementation

    DEFF Research Database (Denmark)

    Hertzum, Morten; Bansler, Jørgen P.; Havn, Erling C.;

    2012-01-01

    to plan and conduct. It is sometimes assumed that pilot implementations are less complicated and risky than ordinary implementations. Pilot implementations are, however, neither prototyping nor small-scale versions of full-scale implementations; they are fundamentally different and have their own...

  4. Avaliando as intenções do empregado mudar de empresa, antes e após a implantação do TQM Assessing employee turnover intentions before/after TQM

    Directory of Open Access Journals (Sweden)

    Tor Guimaraes

    1998-12-01

    Full Text Available Os programas de gerenciamento da qualidade total (TQM - Total Quality Management têm produzido uma significativa lista de benefícios e continuam acumulando adeptos à sua filosofia. Muitos dos requisitos básicos para uma implementação bem sucedida do TQM estão relacionados a mudanças no trabalho das pessoas na empresa, incluindo: a necessidade de trabalhar em equipe e o incentivo ao gerenciamento participativo, o estimulo à criatividade e ao espírito inovador do empregado, uma apropriada forma de recompensa, a criação de um clima organizacional com comprometimento em todos os níveis, feedback do cliente, um ambiente propício a negociação entre empregado e gerente, o incentivo ao envolvimento e energização do empregado para melhoria das comunicações e agilização da tomada de decisões. Qual é o impacto destes requisitos nas intenções do empregado mudar de empresa? O principal propósito deste estudo foi testar empiricamente várias hipóteses que comparam as intenções do funcionário mudar de empresa, e seus antecedentes, nos momentos anterior e posterior à implantação de um programa de TQM. Para analisar essa diferença, utilizou-se do estudo de 113 empregados de uma empresa, anteriormente a implementação do TQM, e de um conjunto menor de 73 empregados desta mesma empresa depois da implementação. Os resultados indicaram uma significativa melhora na delimitação de funções, na satisfação com o trabalho, no envolvimento com o trabalho, no compromisso com a organização e nas intenções de mudança de empresa do empregado; mas não notou-se uma mudança significativa nos conflitos entre funções, nas características das tarefas e na satisfação com a carreira profissional.Total Quality Management programs have produced an impressive list of claimed benefits and continue to accumulate converts to this philosophy. Many of the basic requirements for successful TQM implementation deal with changes in company

  5. How Do Clinical Trials Work?

    Science.gov (United States)

    ... Trials Clinical Trial Websites How Do Clinical Trials Work? If you take part in a clinical trial, ... kol). This plan explains how the trial will work. The trial is led by a principal investigator ( ...

  6. Microbicide clinical trial adherence: insights for introduction.

    Science.gov (United States)

    Woodsong, Cynthia; MacQueen, Kathleen; Amico, K Rivet; Friedland, Barbara; Gafos, Mitzy; Mansoor, Leila; Tolley, Elizabether; McCormack, Sheena

    2013-01-01

    After two decades of microbicide clinical trials it remains uncertain if vaginally- delivered products will be clearly shown to reduce the risk of HIV infection in women and girls. Furthermore, a microbicide product with demonstrated clinical efficacy must be used correctly and consistently if it is to prevent infection. Information on adherence that can be gleaned from microbicide trials is relevant for future microbicide safety and efficacy trials, pre-licensure implementation trials, Phase IV post-marketing research, and microbicide introduction and delivery. Drawing primarily from data and experience that has emerged from the large-scale microbicide efficacy trials completed to-date, the paper identifies six broad areas of adherence lessons learned: (1) Adherence measurement in clinical trials, (2) Comprehension of use instructions/Instructions for use, (3) Unknown efficacy and its effect on adherence/Messages regarding effectiveness, (4) Partner influence on use, (5) Retention and continuation and (6) Generalizability of trial participants' adherence behavior. Each is discussed, with examples provided from microbicide trials. For each of these adherence topics, recommendations are provided for using trial findings to prepare for future microbicide safety and efficacy trials, Phase IV post-marketing research, and microbicide introduction and delivery programs. PMID:23561044

  7. Microbicide clinical trial adherence: insights for introduction

    Directory of Open Access Journals (Sweden)

    Cynthia Woodsong

    2013-04-01

    Full Text Available After two decades of microbicide clinical trials it remains uncertain if vaginally- delivered products will be clearly shown to reduce the risk of HIV infection in women and girls. Furthermore, a microbicide product with demonstrated clinical efficacy must be used correctly and consistently if it is to prevent infection. Information on adherence that can be gleaned from microbicide trials is relevant for future microbicide safety and efficacy trials, pre-licensure implementation trials, Phase IV post-marketing research, and microbicide introduction and delivery. Drawing primarily from data and experience that has emerged from the large-scale microbicide efficacy trials completed to-date, the paper identifies six broad areas of adherence lessons learned: (1 Adherence measurement in clinical trials, (2 Comprehension of use instructions/Instructions for use, (3 Unknown efficacy and its effect on adherence/Messages regarding effectiveness, (4 Partner influence on use, (5 Retention and continuation and (6 Generalizability of trial participants' adherence behavior. Each is discussed, with examples provided from microbicide trials. For each of these adherence topics, recommendations are provided for using trial findings to prepare for future microbicide safety and efficacy trials, Phase IV post-marketing research, and microbicide introduction and delivery programs.

  8. Rationale, design, and implementation protocol of the Dutch clinical practice guideline Pain in patients with cancer: a cluster randomised controlled trial with short message service (SMS) and interactive voice response (IVR)

    OpenAIRE

    te Boveldt Nienke; Engels Yvonne; Besse Kees; Vissers Kris; Vernooij-Dassen Myrra

    2011-01-01

    Abstract Background One-half of patients with cancer have pain. In nearly one out of two cancer patients with pain, this was undertreated. Inadequate pain control still remains an important problem in this group of patients. Therefore, in 2008 a national, evidence-based multidisciplinary clinical practice guideline 'pain in patients with cancer' has been developed. Yet, publishing a guideline is not enough. Implementation is needed to improve pain management. An innovative implementation stra...

  9. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Trials About Clinical Trials A Research Study With Human Subjects A clinical trial is a research study ... lifestyle changes, such as exercising more, getting more sleep, keeping mentally active, or eating nutritious foods, can ...

  10. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Participating in Clinical Trials: About Clinical Trials In This Topic About Clinical Trials Risks and Benefits Terms ... with Your Doctor Taking Medicines The information in this topic was provided by the National Library of ...

  11. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... that could identify a disease in its early stages. Usually, trial participants must show signs of the ... Trials Clinical trials of drugs are usually described based on their phase. The U.S. Food and Drug ...

  12. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... trial is to find out if an experimental drug, therapy, medical device, lifestyle change, or test will ... disease. Phases of Clinical Trials Clinical trials of drugs are usually described based on their phase. The ...

  13. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical trial is a research study that involves human subjects. The purpose of ...

  14. Towards sustainable clinical trials

    OpenAIRE

    Group, Sustainable Trials Study

    2007-01-01

    Currently, few researchers think about the carbon footprint of their trial. The Sustainable Trials Study Group reports that clinical trials are carbon intensive and suggests ways to make them more efficient

  15. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... on. Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical trial is a research study that involves human subjects. The purpose ...

  16. How should we discuss genetic testing with women newly diagnosed with breast cancer? Design and implementation of a randomized controlled trial of two models of delivering education about treatment-focused genetic testing to younger women newly diagnosed with breast cancer

    Directory of Open Access Journals (Sweden)

    Watts Kaaren J

    2012-07-01

    making; and decision regret. A process-oriented retrospective online survey will examine health professionals’ attitudes toward TFGT; a health economic analysis will determine the cost effectiveness of the intervention. Discussion This trial will provide crucial information about the impact, efficiency and cost effectiveness of an educational pamphlet designed to inform younger women newly diagnosed with breast cancer about genetic testing. Issues regarding implementation of the trial are discussed. Trial registration The study is registered with the Australian and New Zealand Clinical Trials Group (Registration no: ACTRN12610000502033

  17. Evaluation of the implementation of an integrated primary care network for prevention and management of cardiometabolic risk in Montréal

    Directory of Open Access Journals (Sweden)

    Provost Sylvie

    2011-11-01

    Full Text Available Abstract Background The goal of this project is to evaluate the implementation of an integrated and interdisciplinary program for prevention and management of cardiometabolic risk (PCMR. The intervention is based on the Chronic Care Model. The study will evaluate the implementation of the PCMR in 6 of the 12 health and social services centres (CSSS in Montréal, and the effects of the PCMR on patients and the practice of their primary care physicians up to 40 months following implementation, as well as the sustainability of the program. Objectives are: 1-to evaluate the effects of the PCMR and their persistence on patients registered in the program and the practice of their primary care physicians, by implementation site and degree of exposure to the program; 2-to assess the degree of implementation of PCMR in each CSSS territory and identify related contextual factors; 3-to establish the relationships between the effects observed, the degree of PCMR implementation and the related contextual factors; 4-to assess the impact of the PCMR on strengthening local services networks. Methods/Design The evaluation will use a mixed design that includes two complementary research strategies. The first strategy is similar to a quasi-experimental "before-after" design, based on a quantitative approach; it will look at the program's effects and their variations among the six territories. The effects analysis will use data from a clinical database and from questionnaires completed by participating patients and physicians. Over 3000 patients will be recruited. The second strategy corresponds to a multiple case study approach, where each of the six CSSS constitutes a case. With this strategy, qualitative methods will set out the context of implementation using data from semi-structured interviews with program managers. The quantitative data will be analyzed using linear or multilevel models complemented with an interpretive approach to qualitative data analysis

  18. Efficacy and safety of vertebroplasty for treatment of painful osteoporotic vertebral fractures: a randomised controlled trial [ACTRN012605000079640

    Directory of Open Access Journals (Sweden)

    Wengier Lainie

    2008-11-01

    Full Text Available Abstract Background Vertebroplasty is a promising but as yet unproven treatment for painful osteoporotic vertebral fractures. It involves radiographic-guided injection of various types of bone cement directly into the vertebral fracture site. Uncontrolled studies and two controlled quasi-experimental before-after studies comparing volunteers who were offered treatment to those who refused it, have suggested an early benefit including rapid pain relief and improved function. Conversely, several uncontrolled studies and one of the controlled before-after studies have also suggested that vertebroplasty may increase the risk of subsequent vertebral fractures, particularly in vertebrae adjacent to treated levels or if cement leakage into the adjacent disc has occurred. As yet, there are no completed randomised controlled trials of vertebroplasty for osteoporotic vertebral fractures. The aims of this participant and outcome assessor-blinded randomised placebo-controlled trial are to i determine the short-term efficacy and safety (3 months of vertebroplasty for alleviating pain and improving function for painful osteoporotic vertebral fractures; and ii determine its medium to longer-term efficacy and safety, particularly the risk of further fracture over 2 years. Design A double-blind randomised controlled trial of 200 participants with one or two recent painful osteoporotic vertebral fractures. Participants will be stratified by duration of symptoms ( Discussion The results of this trial will be of major international importance and findings will be immediately translatable into clinical practice. Trial registration Australian Clinical Trial Register # [ACTRN012605000079640

  19. Paperless clinical trials: Myth or reality?

    Directory of Open Access Journals (Sweden)

    Sandeep K Gupta

    2015-01-01

    Full Text Available There is an urgent need to expedite the time-to-market for new drugs and to make the approval process simpler. But clinical trials are a complex process and the increased complexity leads to decreased efficiency. Hence, pharmaceutical organizations want to move toward a more technology-driven clinical trial process for recording, analyzing, reporting, archiving, etc., In recent times, the progress has certainly been made in developing paperless systems that improve data capture and management. The adaptation of paperless processes may require major changes to existing procedures. But this is in the best interests of these organizations to remain competitive because a paperless clinical trial would lead to a consistent and streamlined framework. Moreover, all major regulatory authorities also advocate adoption of paperless trial. But challenges still remain toward implementation of paperless clinical trial process.

  20. Changes in the Precision of a Study from Planning Phase to Implementation Phase: Evidence from the First Wave of Group Randomized Trials Launched by the Institute of Education Sciences

    Science.gov (United States)

    Spybrook, Jessaca; Lininger, Monica; Cullen, Anne

    2011-01-01

    The purpose of this study is to extend the work of Spybrook and Raudenbush (2009) and examine how the research designs and sample sizes changed from the planning phase to the implementation phase in the first wave of studies funded by IES. The authors examine the impact of the changes in terms of the changes in the precision of the study from the…

  1. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... this page please turn Javascript on. Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical ... to treat or cure a disease. Phases of Clinical Trials Clinical trials of drugs are usually described based ...

  2. Improving patient adherence to lifestyle advice (IMPALA: a cluster-randomised controlled trial on the implementation of a nurse-led intervention for cardiovascular risk management in primary care (protocol

    Directory of Open Access Journals (Sweden)

    Grol Richard

    2008-01-01

    Full Text Available Abstract Background Many patients at high risk of cardiovascular diseases are managed and monitored in general practice. Recommendations for cardiovascular risk management, including lifestyle change, are clearly described in the Dutch national guideline. Although lifestyle interventions, such as advice on diet, physical exercise, smoking and alcohol, have moderate, but potentially relevant effects in these patients, adherence to lifestyle advice in general practice is not optimal. The IMPALA study intends to improve adherence to lifestyle advice by involving patients in decision making on cardiovascular prevention by nurse-led clinics. The aim of this paper is to describe the design and methods of a study to evaluate an intervention aimed at involving patients in cardiovascular risk management. Methods A cluster-randomised controlled trial in 20 general practices, 10 practices in the intervention arm and 10 in the control arm, starting on October 2005. A total of 720 patients without existing cardiovascular diseases but eligible for cardiovascular risk assessment will be recruited. In both arms, the general practitioners and nurses will be trained to apply the national guideline for cardiovascular risk management. Nurses in the intervention arm will receive an extended training in risk assessment, risk communication, the use of a decision aid and adapted motivational interviewing. This communication technique will be used to support the shared decision-making process about risk reduction. The intervention comprises 2 consultations and 1 follow-up telephone call. The nurses in the control arm will give usual care after the risk estimation, according to the national guideline. Primary outcome measures are self-reported adherence to lifestyle advice and drug treatment. Secondary outcome measures are the patients' perception of risk and their motivation to change their behaviour. The measurements will take place at baseline and after 12 and 52

  3. Clinical Trials in Vision Research

    Science.gov (United States)

    ... Eye Health Information > Clinical Trials in Vision Research Clinical Trials in Vision Research Listen Clinical studies depend on ... vision research in the United States. Basics of Clinical Trials What is a clinical trial? Clinical trials are ...

  4. Implementación de un protocolo de actuación para toma de muestras biológicas en juicios de paternidad/Implementation of a protocol for sampling biological tasters in trials of paternity

    Directory of Open Access Journals (Sweden)

    Daniel De La Barrera Escamilla

    2015-01-01

    Full Text Available The scientific and technological advances in forensic research has resulted in recent years in the use of various scientific applications such as Forensic Genetic; the possibility that this area is critical to the identification of persons and the establishment of biological relationship. Since in Mexico, expert evidence on Molecular and Forensic Genetics used in in family and civil trial´s matters, in order to recognize the relationship between individuals has a little over 10 years to be used actively, it is necessary that forensic experts involved in these judgments have a sampling protocol to ensure technical and legally correct way sample collection; and ensure safekeeping and processing them in the laboratory, the aim of which is meet the new requirements of orality.

  5. Clinical trials of homoeopathy.

    OpenAIRE

    Kleijnen, J.; Knipschild, P; ter Riet, G

    1991-01-01

    OBJECTIVE--To establish whether there is evidence of the efficacy of homoeopathy from controlled trials in humans. DESIGN--Criteria based meta-analysis. Assessment of the methodological quality of 107 controlled trials in 96 published reports found after an extensive search. Trials were scored using a list of predefined criteria of good methodology, and the outcome of the trials was interpreted in relation to their quality. SETTING--Controlled trials published world wide. MAIN OUTCOME MEASURE...

  6. The clinically-integrated randomized trial: proposed novel method for conducting large trials at low cost

    Directory of Open Access Journals (Sweden)

    Scardino Peter T

    2009-03-01

    Full Text Available Abstract Introduction Randomized controlled trials provide the best method of determining which of two comparable treatments is preferable. Unfortunately, contemporary randomized trials have become increasingly expensive, complex and burdened by regulation, so much so that many trials are of doubtful feasibility. Discussion Here we present a proposal for a novel, streamlined approach to randomized trials: the "clinically-integrated randomized trial". The key aspect of our methodology is that the clinical experience of the patient and doctor is virtually indistinguishable whether or not the patient is randomized, primarily because outcome data are obtained from routine clinical data, or from short, web-based questionnaires. Integration of a randomized trial into routine clinical practice also implies that there should be an attempt to randomize every patient, a corollary of which is that eligibility criteria are minimized. The similar clinical experience of patients on- and off-study also entails that the marginal cost of putting an additional patient on trial is negligible. We propose examples of how the clinically-integrated randomized trial might be applied in four distinct areas of medicine: comparisons of surgical techniques, "me too" drugs, rare diseases and lifestyle interventions. Barriers to implementing clinically-integrated randomized trials are discussed. Conclusion The proposed clinically-integrated randomized trial may allow us to enlarge dramatically the number of clinical questions that can be addressed by randomization.

  7. Clinical Trial Results: A Clinical Trial Bazaar!

    OpenAIRE

    Fojo, Antonio Tito; Bates, Susan E.

    2014-01-01

    The Oncologist’s Clinical Trial Results section welcomes both positive and negative results in an effort to share information, speed discovery, and inform the field. Clinical Trial Results submissions have shown how succinctly the salient features of a submission can be presented, with more in-depth information to be found online.

  8. Implications of HIV PrEP Trials Results

    OpenAIRE

    Veronese, Fulvia; Anton, Peter; Fletcher, Courtney V.; DeGruttola, Victor; McGowan, Ian; Becker, Stephen; Zwerski, Sheryl; Burns, David

    2011-01-01

    Six randomized clinical trials have been implemented to examine the efficacy of tenofovir disoproxil fumarate (TDF) and/or TDF/emtricitabine (TDF/FTC) as preexposure prophylaxis for HIV-1 infection (PrEP). Although largely complementary, the six trials have many similar features. As the earliest results become available, an urgent question may arise regarding whether changes should be made in the conduct of the other trials. To consider this in advance, a Consultation on the Implications of H...

  9. Two-stage adaptive designs in early phase clinical trials

    OpenAIRE

    Xu, Jiajing; 徐佳静

    2013-01-01

    The primary goal of clinical trials is to collect enough scientific evidence for a new intervention. Despite the widespread use of equal randomization in clinical trials, response-adaptive randomization has attracted considerable interest in terms of ethical concerns. In this thesis, delayed response problems and innovative designs for cytostatic agents in oncology clinical trials are studied. There is typically a prerun of equal randomization before the implementation of response-adaptiv...

  10. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... determine if the drug can be approved for use. A Phase I trial tests an experimental treatment ... the correct drug dosage. A Phase II trial uses more people (100 to 300). While the emphasis ...

  11. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... the body laboratory tests that check samples of blood, urine, or other body tissues genetic tests that look for genes linked to some types of disease. Diagnostic Trials In diagnostic trials, researchers ...

  12. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Clinical Trials In This Topic About Clinical Trials Risks and Benefits Terms to Know Finding a Clinical ... researchers may gather information about experimental treatments, their risks, and how well they work compare existing therapies ...

  13. Research Areas - Clinical Trials

    Science.gov (United States)

    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.

  14. Research Areas: Clinical Trials

    Science.gov (United States)

    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.

  15. Implementation Politics

    DEFF Research Database (Denmark)

    Hegland, Troels Jacob; Raakjær, Jesper

    2008-01-01

    level are supplemented or even replaced by national priorities. The chapter concludes that in order to capture the domestic politics associated with CFP implementation in Denmark, it is important to understand the policy process as a synergistic interaction between dominant interests, policy alliances...

  16. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... was provided by the National Library of Medicine Topic last reviewed: December 2013 For an enhanced version of this page please turn Javascript on. Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical trial is ...

  17. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... topic was provided by the National Library of Medicine Topic last reviewed: December 2013 For an enhanced version of this page please turn Javascript on. Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical trial is a research study ...

  18. European randomized lung cancer screening trials: Post NLST

    DEFF Research Database (Denmark)

    Field, JK; Klaveren, R; Pedersen, JH;

    2013-01-01

    Overview of the European randomized lung cancer CT screening trials (EUCT) is presented with regard to the implementation of CT screening in Europe; post NLST. All seven principal investigators completed a questionnaire on the epidemiological, radiological, and nodule management aspects of their ......Overview of the European randomized lung cancer CT screening trials (EUCT) is presented with regard to the implementation of CT screening in Europe; post NLST. All seven principal investigators completed a questionnaire on the epidemiological, radiological, and nodule management aspects...

  19. AIDS Clinical Trials Group Network

    Science.gov (United States)

    ... Center Statistical and Data Management Center Glossaries Sites Clinical Trials About the Trial Process Trials Open to Enrollment Recent Study Results Access to Published Data Clinical Trials Resources Committees Executive Scientific Resource Community General Information ...

  20. A data grid for imaging-based clinical trials

    Science.gov (United States)

    Zhou, Zheng; Chao, Sander S.; Lee, Jasper; Liu, Brent; Documet, Jorge; Huang, H. K.

    2007-03-01

    Clinical trials play a crucial role in testing new drugs or devices in modern medicine. Medical imaging has also become an important tool in clinical trials because images provide a unique and fast diagnosis with visual observation and quantitative assessment. A typical imaging-based clinical trial consists of: 1) A well-defined rigorous clinical trial protocol, 2) a radiology core that has a quality control mechanism, a biostatistics component, and a server for storing and distributing data and analysis results; and 3) many field sites that generate and send image studies to the radiology core. As the number of clinical trials increases, it becomes a challenge for a radiology core servicing multiple trials to have a server robust enough to administrate and quickly distribute information to participating radiologists/clinicians worldwide. The Data Grid can satisfy the aforementioned requirements of imaging based clinical trials. In this paper, we present a Data Grid architecture for imaging-based clinical trials. A Data Grid prototype has been implemented in the Image Processing and Informatics (IPI) Laboratory at the University of Southern California to test and evaluate performance in storing trial images and analysis results for a clinical trial. The implementation methodology and evaluation protocol of the Data Grid are presented.

  1. Understanding noninferiority trials

    Directory of Open Access Journals (Sweden)

    Seokyung Hahn

    2012-11-01

    Full Text Available Noninferiority trials test whether a new experimental treatment is not unacceptably less efficacious than an active control treatment already in use. With continuous improvements in health technologies, standard care, and clinical outcomes, the incremental benefits of newly developed treatments may be only marginal over existing treatments. Sometimes assigning patients to a placebo is unethical. In such circumstances, there has been increasing emphasis on the use of noninferiority trial designs. Noninferiority trials are more complex to design, conduct, and interpret than typical superiority trials. This paper reviews the concept of noninferiority trials and discusses some important issues related to them.

  2. Fusion Implementation

    International Nuclear Information System (INIS)

    If a fusion DEMO reactor can be brought into operation during the first half of this century, fusion power production can have a significant impact on carbon dioxide production during the latter half of the century. An assessment of fusion implementation scenarios shows that the resource demands and waste production associated with these scenarios are manageable factors. If fusion is implemented during the latter half of this century it will be one element of a portfolio of (hopefully) carbon dioxide limiting sources of electrical power. It is time to assess the regional implications of fusion power implementation. An important attribute of fusion power is the wide range of possible regions of the country, or countries in the world, where power plants can be located. Unlike most renewable energy options, fusion energy will function within a local distribution system and not require costly, and difficult, long distance transmission systems. For example, the East Coast of the United States is a prime candidate for fusion power deployment by virtue of its distance from renewable energy sources. As fossil fuels become less and less available as an energy option, the transmission of energy across bodies of water will become very expensive. On a global scale, fusion power will be particularly attractive for regions separated from sources of renewable energy by oceans

  3. Recruitment and Retention of Patients into Emergency Medicine Clinical Trials

    Science.gov (United States)

    Cofield, Stacey; Conwit, Robin; Barsan, William; Quinn, James

    2010-01-01

    The emergency medicine and pre-hospital environments are unlike any other clinical environments and require special consideration to allow the successful implementation of clinical trials. This article reviews the specific issues involved in Emergency Medicine Clinical Trials (EMCT), and provides strategies from emergency medicine and non-emergency medicine trials to maximize recruitment and retention. While the evidence supporting some of these strategies is deficient, addressing recruitment and retention issues with specific strategies will help researchers deal with these issues in their funding applications and in turn develop the necessary infrastructure to participate in emergency medicine clinical trials. PMID:21040112

  4. Improving the operational efficiency of Phase 2 and 3 trials.

    Science.gov (United States)

    Ganju, Jitendra

    2016-01-01

    The period toward the end of patients' participation in late stage blinded clinical trials is highly resource intensive for the sponsor. Consider first a Phase 3 trial. If the trial is a success, the sponsor has to implement the next steps, which might be filing for approval of the drug with the US Food and Drug Administration (FDA). To shorten the time interval between trial completion and submission of the package to the FDA, sponsors front-load as much work as is possible at risk. The approach is efficient if the trial succeeds but is inefficient if it fails. For a failed trial, the sponsor is unlikely to proceed with the plan that assumed success. Phase 2 trials are also at risk of being inefficient. Many activities, such as planning for drug interaction studies, thorough QT studies, or site selection for Phase 3 trials, are set in motion prior to completion of the Phase 2 trial. The work going on in parallel is wasted if the trial fails. The proposal to improve the efficiency is to let an independent entity provide the sponsor critical information at an earlier time necessary to reevaluate activities ongoing in parallel and external to the trial. PMID:27439520

  5. Frailty Intervention Trial (FIT

    Directory of Open Access Journals (Sweden)

    Lockwood Keri

    2008-10-01

    Full Text Available Abstract Background Frailty is a term commonly used to describe the condition of an older person who has chronic health problems, has lost functional abilities and is likely to deteriorate further. However, despite its common use, only a small number of studies have attempted to define the syndrome of frailty and measure its prevalence. The criteria Fried and colleagues used to define the frailty syndrome will be used in this study (i.e. weight loss, fatigue, decreased grip strength, slow gait speed, and low physical activity. Previous studies have shown that clinical outcomes for frail older people can be improved using multi-factorial interventions such as comprehensive geriatric assessment, and single interventions such as exercise programs or nutritional supplementation, but no interventions have been developed to specifically reverse the syndrome of frailty. We have developed a multidisciplinary intervention that specifically targets frailty as defined by Fried et al. We aim to establish the effects of this intervention on frailty, mobility, hospitalisation and institutionalisation in frail older people. Methods and Design A single centre randomised controlled trial comparing a multidisciplinary intervention with usual care. The intervention will target identified characteristics of frailty, functional limitations, nutritional status, falls risk, psychological issues and management of chronic health conditions. Two hundred and thirty people aged 70 and over who meet the Fried definition of frailty will be recruited from clients of the aged care service of a metropolitan hospital. Participants will be followed for a 12-month period. Discussion This research is an important step in the examination of specifically targeted frailty interventions. This project will assess whether an intervention specifically targeting frailty can be implemented, and whether it is effective when compared to usual care. If successful, the study will establish a

  6. Overexpectation and Trial Massing

    OpenAIRE

    Sissons, Heather T.; Miller, Ralph R.

    2009-01-01

    Three experiments were conducted to examine the interaction of overexpectation treatment and trial massing using a Pavlovian fear conditioning procedure with rats. In first-order conditioning, Experiment 1 found the overexpectation effect (i.e., decreased conditioned responding to a cue after compound training when the elements were previously reinforced), the trial spacing effect (i.e., decreased responding to a cue when reinforced trials are massed), and a counteraction between overexpectat...

  7. Compliance in clinical trials.

    OpenAIRE

    Pullar, T; Kumar, S; Feely, M

    1989-01-01

    Compliance with treatment can be an important determinant of the outcome of clinical trials. To date there is no completely satisfactory method of measuring compliance and some of the most widely used methods are inadequate. The various methods of measuring compliance and how they have been applied to clinical trials are described, and improvements in the standard of the measurement and reporting of compliance in clinical trials are suggested.

  8. A Multi-Method Process Evaluation for a Skin Cancer Prevention Diffusion Trial

    OpenAIRE

    Escoffery, Cam; Glanz, Karen; Hall, Dawn; Elliott, Tom

    2009-01-01

    This article describes process evaluation methods for the Pool Cool Diffusion Trial across four years. Pool Cool is a skin cancer prevention program that was found to improve behaviors and environments for sun protection at swimming pools in a randomized efficacy trial, which was followed by a national Diffusion Trial. The process evaluation focus shifted from measuring program satisfaction to assessing widespread program implementation, barriers and facilitators to implementation, and progra...

  9. Trials within trials? Researcher, funder and ethical perspectives on the practicality and acceptability of nesting trials of recruitment methods in existing primary care trials

    Directory of Open Access Journals (Sweden)

    Delaney Brendan

    2010-04-01

    Full Text Available Abstract Background Trials frequently encounter difficulties in recruitment, but evidence on effective recruitment methods in primary care is sparse. A robust test of recruitment methods involves comparing alternative methods using a randomized trial, 'nested' in an ongoing 'host' trial. There are potential scientific, logistical and ethical obstacles to such studies. Methods Telephone interviews were undertaken with four groups of stakeholders (funders, principal investigators, trial managers and ethics committee chairs to explore their views on the practicality and acceptability of undertaking nested trials of recruitment methods. These semi-structured interviews were transcribed and analysed thematically. Results Twenty people were interviewed. Respondents were familiar with recruitment difficulties in primary care and recognised the case for 'nested' studies to build an evidence base on effective recruitment strategies. However, enthusiasm for this global aim was tempered by the challenges of implementation. Challenges for host studies included increasing complexity and management burden; compatibility between the host and nested study; and the impact of the nested study on trial design and relationships with collaborators. For nested recruitment studies, there were concerns that host study investigators might have strong preferences, limiting the nested study investigators' control over their research, and also concerns about sample size which might limit statistical power. Nested studies needed to be compatible with the main trial and should be planned from the outset. Good communication and adequate resources were seen as important. Conclusions Although research on recruitment was welcomed in principle, the issue of which study had control of key decisions emerged as critical. To address this concern, it appeared important to align the interests of both host and nested studies and to reduce the burden of hosting a recruitment trial. These

  10. Imperfect placebos are common in low back pain trials: a systematic review of the literature

    OpenAIRE

    Machado, L.A.C.; Kamper, S. J.; Herbert, R. D.; Maher, C. G.; McAuley, J. H.

    2008-01-01

    The placebo is an important tool to blind patients to treatment allocation and therefore minimise some sources of bias in clinical trials. However, placebos that are improperly designed or implemented may introduce bias into trials. The purpose of this systematic review was to evaluate the adequacy of placebo interventions used in low back pain trials. Electronic databases were searched systematically for randomised placebo-controlled trials of conservative interventions for low back pain. Tr...

  11. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... on their phase. The U.S. Food and Drug Administration typically requires Phase 1, 2 and 3 trials ... 000 people. If the U.S. Food and Drug Administration agrees that the trial results are positive, they ...

  12. Comparability of prostate trials

    DEFF Research Database (Denmark)

    Suciu, S; Sylvester, R; Iversen, P;

    1993-01-01

    The present overview of advanced prostate cancer required the identification of randomized clinical trials studying the question of maximal androgen blockade versus the classic castration therapy. The heterogeneity of the trials concerned the type of castration (surgical or chemical) and the type...

  13. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... can include imaging tests that produce pictures of what is inside the body laboratory tests that check samples of blood, urine, or other body tissues genetic tests that look for genes linked to some types of disease. Diagnostic Trials In diagnostic trials, researchers ...

  14. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... In This Topic About Clinical Trials Risks and Benefits Terms to Know Finding a Clinical Trial Informed ... for more information Scientists usually do years of experiments in the laboratory and in animals before they even consider testing an experimental treatment ...

  15. The COLOFOL trial

    DEFF Research Database (Denmark)

    Hansdotter Andersson, Pernilla; Wille-Jørgensen, Peer; Horváth-Puhó, Erzsébet;

    2016-01-01

    trial, comparing demographic characteristics between randomized patients and eligible patients not included in the study. MATERIALS AND METHODS: COLOFOL was designed as a pragmatic trial with wide inclusion criteria and few exclusion criteria, in order to obtain a sample reflecting the general patient...

  16. Miscanthus production field trials

    Energy Technology Data Exchange (ETDEWEB)

    Jones, B. [University Coll., Dublin (Ireland)

    1993-12-31

    Under the E.C. Joule program in 1989, a European network started on 18 sites a replicated production trial of an asian plant to produce biomass. The trials show that it is possible to successfully establish a Miscanthus crop under a wide range of climatic and edaphic conditions in Europe. Tests and results are presented. (TEC).

  17. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... disease or prevent a disease from returning. Supportive Care Trials In supportive care trials, researchers look for ways to make life ... groups, and various types of social interventions. Supportive care interventions are not intended to treat or cure ...

  18. Comparability of prostate trials

    DEFF Research Database (Denmark)

    Suciu, S; Sylvester, R; Iversen, P; Christensen, I; Denis, L

    The present overview of advanced prostate cancer required the identification of randomized clinical trials studying the question of maximal androgen blockade versus the classic castration therapy. The heterogeneity of the trials concerned the type of castration (surgical or chemical) and the type...

  19. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... In This Topic About Clinical Trials Risks and Benefits Terms to Know Finding a Clinical Trial Informed ... years of experiments in the laboratory and in animals before they even ... this early research occurs at universities and medical centers across the ...

  20. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... care trials, researchers look for ways to make life better for people living with a life threatening disease or chronic health problem. The goal ... IV trial for drugs or devices takes place after the U.S. Food and Drug Administration approves their ...

  1. CLINICAL TRIALS.GOV

    Science.gov (United States)

    ClinicalTrials.gov provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases and conditions. The U.S. National Institutes of Health (NIH), through its National Library of Medi...

  2. Key concepts of clinical trials: a narrative review.

    Science.gov (United States)

    Umscheid, Craig A; Margolis, David J; Grossman, Craig E

    2011-09-01

    The recent focus of federal funding on comparative effectiveness research underscores the importance of clinical trials in the practice of evidence-based medicine and health care reform. The impact of clinical trials not only extends to the individual patient by establishing a broader selection of effective therapies, but also to society as a whole by enhancing the value of health care provided. However, clinical trials also have the potential to pose unknown risks to their participants, and biased knowledge extracted from flawed clinical trials may lead to the inadvertent harm of patients. Although conducting a well-designed clinical trial may appear straightforward, it is founded on rigorous methodology and oversight governed by key ethical principles. In this review, we provide an overview of the ethical foundations of trial design, trial oversight, and the process of obtaining approval of a therapeutic, from its pre-clinical phase to post-marketing surveillance. This narrative review is based on a course in clinical trials developed by one of the authors (DJM), and is supplemented by a PubMed search predating January 2011 using the keywords "randomized controlled trial," "patient/clinical research," "ethics," "phase IV," "data and safety monitoring board," and "surrogate endpoint." With an understanding of the key principles in designing and implementing clinical trials, health care providers can partner with the pharmaceutical industry and regulatory bodies to effectively compare medical therapies and thereby meet one of the essential goals of health care reform. PMID:21904102

  3. Fundamentals of clinical trials

    CERN Document Server

    Friedman, Lawrence M; DeMets, David L; Reboussin, David M; Granger, Christopher B

    2015-01-01

    This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise.  Most chapters have been revised considerably from the fourth edition.  A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded.  Many contemporary clinical trial examples have been added.  There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials.  This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of ...

  4. Gatekeepers for pragmatic clinical trials.

    Science.gov (United States)

    Whicher, Danielle M; Miller, Jennifer E; Dunham, Kelly M; Joffe, Steven

    2015-10-01

    To successfully implement a pragmatic clinical trial, investigators need access to numerous resources, including financial support, institutional infrastructure (e.g. clinics, facilities, staff), eligible patients, and patient data. Gatekeepers are people or entities who have the ability to allow or deny access to the resources required to support the conduct of clinical research. Based on this definition, gatekeepers relevant to the US clinical research enterprise include research sponsors, regulatory agencies, payers, health system and other organizational leadership, research team leadership, human research protections programs, advocacy and community groups, and clinicians. This article provides a framework to help guide gatekeepers' decision-making related to the use of resources for pragmatic clinical trials. Relevant ethical considerations for gatekeepers include (1) concern for the interests of individuals, groups, and communities affected by the gatekeepers' decisions, including protection from harm and maximization of benefits; (2) advancement of organizational mission and values; and (3) stewardship of financial, human, and other organizational resources. Separate from these ethical considerations, gatekeepers' actions will be guided by relevant federal, state, and local regulations. This framework also suggests that to further enhance the legitimacy of their decision-making, gatekeepers should adopt transparent processes that engage relevant stakeholders when feasible and appropriate. We apply this framework to the set of gatekeepers responsible for making decisions about resources necessary for pragmatic clinical trials in the United States, describing the relevance of the criteria in different situations and pointing out where conflicts among the criteria and relevant regulations may affect decision-making. Recognition of the complex set of considerations that should inform decision-making will guide gatekeepers in making justifiable choices regarding

  5. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... experimental drug, therapy, medical device, lifestyle change, or test will help treat, find, or prevent a disease. A clinical trial may compare experimental products or tests to those already available or may compare existing ...

  6. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... out if an experimental drug, therapy, medical device, lifestyle change, or test will help treat, find, or ... specific medical problem. These trials find out if lifestyle changes, such as exercising more, getting more sleep, ...

  7. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... radiotherapy. Click for more information Scientists usually do years of experiments in the laboratory and in animals ... term side effects. This phase can last several years. A Phase III trial gathers more information about ...

  8. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Drug Administration typically requires Phase 1, 2 and 3 trials to be conducted to determine if the ... subjects usually ranges from several hundred to about 3,000 people. If the U.S. Food and Drug ...

  9. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Katz, J N; Losina, E; Lohmander, L S

    2015-01-01

    To highlight methodological challenges in the design and conduct of randomized trials of surgical interventions and to propose strategies for addressing these challenges. This paper focuses on three broad areas: enrollment; intervention; and assessment including implications for analysis. For eac...

  10. Clinical Trial Basics

    Science.gov (United States)

    ... Human Services Search the NIH Website NIH Employee Intranet Staff Directory En Español Site Menu Home Health ... am thinking about participating? Xsandra/iStock Risks and benefits Clinical trials involve risks, just as routine medical ...

  11. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... was provided by the National Library of Medicine Topic last reviewed: December 2013 For an enhanced version of this page please turn Javascript on. Participating in Clinical Trials ...

  12. Participating in Clinical Trials

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    Full Text Available ... ways of finding a disease before symptoms occur. These methods, often called screening tests, can include imaging ... getting a disease or a specific medical problem. These trials find out if lifestyle changes, such as ...

  13. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Researchers may study the role of caregivers, support groups, and various types of social interventions. Supportive care ... trial tests an experimental treatment on a small group of often healthy people (20 to 80), to ...

  14. ClinicalTrials.gov

    Data.gov (United States)

    U.S. Department of Health & Human Services — Provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases...

  15. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Learn More Participating in Clinical Trials Videos quiz yourself MedlinePlus for More Information National Institute on Aging Related Topics Talking with Your Doctor Taking Medicines The information in ...

  16. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... in this topic was provided by the National Library of Medicine Topic last reviewed: December 2013 For ... on their phase. The U.S. Food and Drug Administration typically requires Phase 1, 2 and 3 trials ...

  17. Polyp Prevention Trial

    Science.gov (United States)

    The primary objective of the Polyp Prevention Trial (PPT) is to determine whether a low fat, high fiber, high vegetable and fruit eating plan will decrease the recurrence of adenomatous polyps of the large bowel.

  18. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Clinical Trials Videos quiz yourself MedlinePlus for More Information National Institute on Aging Related Topics Talking with Your Doctor Taking Medicines The information in this topic was provided by the National ...

  19. Research of influencing factors on the implementation of "general hospital guiding principles of nursing classification (trial)"%影响《综合医院分级护理指导原则(试行)》实施的因素分析

    Institute of Scientific and Technical Information of China (English)

    刘晓丹; 宫建美; 张静; 李娜

    2012-01-01

    目的 研究《综合医院分级护理指导原则(试行)》(以下简称《原则》)在临床护理工作中实施的影响因素.方法 自行设计问卷,采用方便抽样的方法,抽取长春市3所三级甲等医院的152名护士和143名医生为调查对象,并对调查数据进行统计分析.结果 护士方面,护士的责任心、护士的数量、护士的基本素质影响程度较高,居各影响因素的前3位;分级护理标准、领导的重视程度、病种的差异性影响程度较低,居各相关因素的后3位;医生、护士对《原则》实施的影响因素认知存在差异.结论 提高《原则》的执行力,必须统一医护人员对《原则》的认知,提升护理人员的基本素质、责任心,有效地实施护理人力资源管理.%Objective To explore the influencing factors of the implementation of "general hospital guiding principles of nursing classification (trial)" in clinical nursing work.Methods 152 nurses and 143 doctors were selected from three 3A-level hospitals in Changchun and were investigated with self-designed questionnaires,and the data were statistically analyzed.Results The first three influencing factors were the responsibility,quantity and basic qualities of nurses.Grading nursing standards,leadership value degree and the differences of disease had lower influencing degree.There were cognitive differences between nurses and doctors on the influencing factors on implementation of the principle.Conclusions To improve execution of the principles,the cognition of doctors and nurses on the principles must be unified.Increasing nurses' basic quality and responsibility and carrying out effective human resources management are very useful.

  20. An Analysis of Preference Relative to Teacher Implementation of Intervention

    Science.gov (United States)

    Johnson, LeAnne D.; Wehby, Joseph H.; Symons, Frank J.; Moore, Tara C.; Maggin, Daniel M.; Sutherland, Kevin S.

    2014-01-01

    The purpose of this study was to conduct a preference trial as a preliminary test of preference effects on teacher behavior relative to implementation (adoption, adherence, quality). Teachers were randomly assigned to "preference" or "no-preference" groups and then trained to implement the intervention. Direct observation…

  1. Strategies for Implementing Change: An Experiential Approach

    OpenAIRE

    JS Armstrong

    2004-01-01

    An attitude survey and a role-playing case were used to identify the typical approaches people use to implement important changes in organizations. This typical strategy, suggested or used by over 90% of the subjects, was not successful in producing change in any of the fourteen role-playing trials. However, with ten minutes of instruction in the ”Delta Technique,” 86% of the subjects were successful in introducing change in another fourteen role-playing trials. The ”Delta Technique” consists...

  2. Implementation of BNCT treatment planning procedures

    International Nuclear Information System (INIS)

    Estimation of radiation doses delivered during boron neutron capture therapy (BNCT) requires combining data on spatial distribution of both the thermal neutron fluence and the 10B concentration, as well as the relative biological effectiveness of various radiation dose components in the tumor and normal tissues. Using the treatment planning system created at Idaho National Engineering and Environmental Laboratory and the procedures we had developed for clinical trials, we were able to optimize the treatment position, safely deliver the prescribed BNCT doses, and carry out retrospective analyses and reviews. In this paper we describe the BNCT treatment planning process and its implementation in the ongoing dose escalation trials at Brookhaven National Laboratory. (author)

  3. Reducing the confusion and controversies around pragmatic trials: using the Cardiovascular Health Awareness Program (CHAP) trial as an illustrative example

    OpenAIRE

    Thabane, Lehana; Kaczorowski, Janusz; Dolovich, Lisa; Larry W. Chambers; Mbuagbaw, Lawrence; ,

    2015-01-01

    Abstract Knowledge translation (KT) involves implementation of evidence-based strategies and guidelines into practice to improve the process of care and health outcomes for patients. Findings from pragmatic trials may be used in KT to provide patients, healthcare providers and policymakers with information to optimize healthcare decisions based on how a given strategy or intervention performs under the real world conditions. However, pragmatic trials have been criticized for having the follow...

  4. Update on the transfusion in gastrointestinal bleeding (TRIGGER) trial: statistical analysis plan for a cluster-randomised feasibility trial

    OpenAIRE

    Kahan, B. C.; Jairath, V; Murphy, M F; Doré, C. J.

    2013-01-01

    Background Previous research has suggested an association between more liberal red blood cell (RBC) transfusion and greater risk of further bleeding and mortality following acute upper gastrointestinal bleeding (AUGIB). Methods and design The Transfusion in Gastrointestinal Bleeding (TRIGGER) trial is a pragmatic cluster-randomised feasibility trial which aims to evaluate the feasibility of implementing a restrictive vs. liberal RBC transfusion policy for adult patients admitted to hospital w...

  5. Methodological considerations for a randomised controlled trial of podiatry care in rheumatoid arthritis: lessons from an exploratory trial

    OpenAIRE

    Helliwell Philip S; Turner Deborah E; Woodburn James

    2007-01-01

    Abstract Background Whilst evidence exists to support the use of single treatments such as orthoses and footwear, the effectiveness of podiatry-led care as a complex intervention for patients with rheumatoid arthritis (RA) related foot problems is unknown. The aim of this study was to undertake an exploratory randomised controlled parallel arm clinical trial (RheumAFooT) to inform the design and implementation of a definitive trial and to understand the potential benefits of this care. Method...

  6. Complementary and Alternative Medicine Cancer Clinical Trials

    Science.gov (United States)

    ... Introduction Cancer CAM Clinical Trials Introduction What are clinical trials? A clinical trial is one of the final ... and effective. What are the different types of clinical trials? Treatment trials test new treatments (like a new ...

  7. The Radiation oncology practice standards trial

    International Nuclear Information System (INIS)

    Full text: In 2008 the Commonwealth Government approved funding of up to $1.4 million for radiation oncology practice standards (the standards) to be drafted, trialled, finalised and published. A Tripartite Standards Committee comprising representatives from the Royal Australian and New Zealand College of Radiologists (RANZCR), Australian Insti tute of Radiography (AIR) and Australasian College of Physical Scientists and Engineers in Medicine (ACPSEM) coordinated and managed the drafting of the standards. Following public consultation in September 2008, the draft standards were endorsed for trjalling by the Radiation Oncology Reform Implementation Committee (RORIC) of the Australian Health Ministers' Advisory Council (AHMAC). In June 2009 the National Association of Testing Authorities, Australia (NATA) was engaged by the Department of Health and Ageing to conduct a trial of the draft standards by collecting feedback on their implementability with a representative sample of radiation oncology facilities. The trial formally commenced in January 20 I 0 and data is being collected via an on-line questionnaire, follow up site visits and a focus group meeting. The results will be used to establish baseline data on compliance and to assess the costs of compliance. A steering committee comprising representatives from the Tripartite Standards Committee is assisting the Commonwealth to oversight the project. The standards trial is due for completion by the end of 20 I 0, subject to facilities completing all components of the trial in the required time. The outcomes of the trial will inform a revision of the standards by the Tripartite Standards Committee for finalisation and publication. At this time consideration will be given to the tools required by facilities to assist their longer term use within the sector. This may include how compliance with the standards might be assessed. This presentation will describe the process and findings to date and describe the next steps

  8. Adaptive trial designs.

    Science.gov (United States)

    Lai, Tze Leung; Lavori, Philip William; Shih, Mei-Chiung

    2012-01-01

    We review adaptive designs for clinical trials, giving special attention to the control of the Type I error in late-phase confirmatory trials, when the trial planner wishes to adjust the final sample size of the study in response to an unblinded analysis of interim estimates of treatment effects. We point out that there is considerable inefficiency in using the adaptive designs that employ conditional power calculations to reestimate the sample size and that maintain the Type I error by using certain weighted test statistics. Although these adaptive designs have little advantage over familiar group-sequential designs, our review also describes recent developments in adaptive designs that are both flexible and efficient. We also discuss the use of Bayesian designs, when the context of use demands control over operating characteristics (Type I and II errors) and correction of the bias of estimated treatment effects. PMID:21838549

  9. Implementation salvage experiences from the Melbourne diabetes prevention study

    Directory of Open Access Journals (Sweden)

    Dunbar James

    2012-09-01

    Full Text Available Abstract Background Many public health interventions based on apparently sound evidence from randomised controlled trials encounter difficulties when being scaled up within health systems. Even under the best of circumstances, implementation is exceedingly difficult. In this paper we will describe the implementation salvage experiences from the Melbourne Diabetes Prevention Study, which is a randomised controlled trial of the effectiveness and cost-effectiveness nested in the state-wide Life! Taking Action on Diabetes program in Victoria, Australia. Discussion The Melbourne Diabetes Prevention Study sits within an evolving larger scale implementation project, the Life! program. Changes that occurred during the roll-out of that program had a direct impact on the process of conducting this trial. The issues and methods of recovery the study team encountered were conceptualised using an implementation salvage strategies framework. The specific issues the study team came across included continuity of the state funding for Life! program and structural changes to the Life! program which consisted of adjustments to eligibility criteria, referral processes, structure and content, as well as alternative program delivery for different population groups. Staff turnover, recruitment problems, setting and venue concerns, availability of potential participants and participant characteristics were also identified as evaluation roadblocks. Each issue and corresponding salvage strategy is presented. Summary The experiences of conducting such a novel trial as the preliminary Melbourne Diabetes Prevention Study have been invaluable. The lessons learnt and knowledge gained will inform the future execution of this trial in the coming years. We anticipate that these results will also be beneficial to other researchers conducting similar trials in the public health field. We recommend that researchers openly share their experiences, barriers and challenges when

  10. Maximal Usage Trial: An Overview of the Design of Systemic Bioavailability Trial for Topical Dermatological Products

    OpenAIRE

    Bashaw, Edward Dennis; Tran, Doanh C.; Shukla, Chinmay G.; Liu, Xiaomei

    2014-01-01

    Dermatologic diseases can present in varying forms and severity, ranging from the individual lesion and up to almost total skin involvement. Pharmacokinetic assessment of topical drug products has previously been plagued by bioanalytical assay limitations and the lack of a standardized study design. Since the mid-1990's the US Food and Drug Administration has developed and implemented a pharmacokinetic maximal usage trial (MUsT) design to help address these issues. The MUsT design takes into ...

  11. Preparing for ERP Implementation

    OpenAIRE

    Karkio, Antti

    2014-01-01

    This Thesis develops a proposal for Operations and the local management in the case company how to prepare for ERP implementation and ensure successful implementation. ERP implementation can be considered successful when the ERP system has been in effective use after a certain period of time after implementation. The objective of this Thesis is to create recommendations and action points how to ensure the efficient implementation of ERP. The Thesis is focused on the pre-implementation ph...

  12. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... care trials, researchers look for ways to make life better for people living with a life threatening disease or chronic health problem. The goal ... experimental treatment on a small group of often healthy people (20 to 80), to judge its safety ...

  13. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... to find out if an experimental drug, therapy, medical device, lifestyle change, or test will help treat, find, or prevent a disease. A clinical trial may compare experimental products or ... universities and medical centers across the country. The National Institutes of ...

  14. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... care trials, researchers look for ways to make life better for people living with a life threatening disease or chronic health problem. The goal ... to obtain preliminary data on whether the drug works in people who have a certain disease or ...

  15. Randomised clinical trial

    DEFF Research Database (Denmark)

    Reimer, C; Lødrup, A B; Smith, G;

    2016-01-01

    of an alginate (Gaviscon Advance, Reckitt Benckiser, Slough, UK) on reflux symptoms in patients with persistent symptoms despite once daily PPI. METHODS: This was a multicentre, randomised, placebo-controlled, 7-day double-blind trial preceded by a 7-day run-in period. Reflux symptoms were assessed using...

  16. Randomized clinical trial

    DEFF Research Database (Denmark)

    Olesen, Anne Estrup; Nielsen, Lecia Møller; Larsen, Isabelle Myriam;

    2015-01-01

    : The study was a randomized, double-blinded, placebo-controlled, crossover trial in healthy males. Esophageal electrical, thermal, mechanical, and chemical stimulations were performed, pain perception was rated, and referred pain areas were drawn. Sensitization was induced by intraluminal esophageal acid...

  17. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... are usually described based on their phase. The U.S. Food and Drug Administration typically requires Phase 1, ... hundred to about 3,000 people. If the U.S. Food and Drug Administration agrees that the trial ...

  18. Hepatitis C: Clinical Trials

    Science.gov (United States)

    ... Reports Clinician Tools Clinician Tools Home Guidelines and Best Practices Topic Reviews Algorithms, Screens, Toolkits Provider Education Provider ... about federally and privately supported clinical research in human volunteers. Site gives information about a trial's purpose, who may participate, locations, and phone ... Forms State and Local Resources Strat Plan FY 2014-2020 VA Plans, Budget, & ...

  19. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... usually described based on their phase. The U.S. Food and Drug Administration typically requires Phase 1, 2 and 3 ... to about 3,000 people. If the U.S. Food and Drug Administration agrees that the trial results are positive, ...

  20. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Kraus, V B; Blanco, F J; Englund, M;

    2015-01-01

    The objective of this work was to describe requirements for inclusion of soluble biomarkers in osteoarthritis (OA) clinical trials and progress toward OA-related biomarker qualification. The Guidelines for Biomarkers Working Group, representing experts in the field of OA biomarker research from b...

  1. Impact of copula directional specification on multi-trial evaluation of surrogate endpoints

    OpenAIRE

    Renfro, Lindsay A.; Shang, Hongwei; Sargent, Daniel J

    2015-01-01

    Evaluation of surrogate endpoints using patient-level data from multiple trials is the gold standard, where multi-trial copula models are used to quantify both patient-level and trial-level surrogacy. While limited consideration has been given in the literature to copula choice (e.g., Clayton), no prior consideration has been given to direction of implementation (via survival versus distribution functions). We demonstrate that evenwith the “correct” copula family, directional misspecification...

  2. HIV/AIDS Clinical Trials

    Science.gov (United States)

    ... Home Apps APIs Widgets Order Publications Skip Nav HIV/AIDS Clinical Trials Home > Clinical Trials Español small ... Renal (Kidney) Complications/Damage Skin Diseases FDA-Approved HIV Drugs Abacavir Atazanavir Atripla Cobicistat Combivir Complera Darunavir ...

  3. Registration of randomized clinical trials

    DEFF Research Database (Denmark)

    Østervig, R M; Sonne, A; Rasmussen, L S

    2015-01-01

    the proportion of correctly registered randomized controlled trials (RCTs) published in Acta from 2009 to 2014. METHODS: We manually searched all Acta issues from 2009 to 2014 for RCTs. Information about timing of data collection and registration in trial registries was extracted. We classified RCTs as correctly...... starting enrolment before 2010 to 63.2% after 2010 (24/38, P randomized controlled trials from Acta Anaesthesiologica Scandinavica were not adequately registered but the requirement of trial registration has...

  4. Survey and Practice of Reporting Quality of Randomized Controlled Clinical Trials on Traditional Chinese Medicine

    Institute of Scientific and Technical Information of China (English)

    LI Ting-qian; MAO Bing; WANG Gang; CHANG Jing; WANG Lei

    2008-01-01

    @@ Evidence obtained from randomized controlled trials (RCTs) has been generally accepted as the gold standard in the evaluation of clinical effectiveness. Readers need to understand the trial design, implementation, results, analysis and interpretation, so as to fully understand the results of RCTs. Thus, the investigators of RCTs have to report these items in a complete, accurate and clear manner.

  5. Randomization in substance abuse clinical trials

    Directory of Open Access Journals (Sweden)

    Woolson Robert F

    2006-02-01

    Full Text Available Abstract Background A well designed randomized clinical trial rates as the highest level of evidence for a particular intervention's efficacy. Randomization, a fundamental feature of clinical trials design, is a process invoking the use of probability to assign treatment interventions to patients. In general, randomization techniques pursue the goal of providing objectivity to the assignment of treatments, while at the same time balancing for treatment assignment totals and covariate distributions. Numerous randomization techniques, each with varying properties of randomness and balance, are suggested in the statistical literature. This paper reviews common randomization techniques often used in substance abuse research and an application from a National Institute on Drug Abuse (NIDA-funded clinical trial in substance abuse is used to illustrate several choices an investigator faces when designing a clinical trial. Results Comparisons and contrasts of randomization schemes are provided with respect to deterministic and balancing properties. Specifically, Monte Carlo simulation is used to explore the balancing nature of randomization techniques for moderately sized clinical trials. Results demonstrate large treatment imbalance for complete randomization with less imbalance for the urn or adaptive scheme. The urn and adaptive randomization methods display smaller treatment imbalance as demonstrated by the low variability of treatment allocation imbalance. For all randomization schemes, covariate imbalance between treatment arms was small with little variation between adaptive schemes, stratified schemes and unstratified schemes given that sample sizes were moderate to large. Conclusion We develop this paper with the goal of reminding substance abuse researchers of the broad array of randomization options available for clinical trial designs. There may be too quick a tendency for substance abuse researchers to implement the fashionable urn

  6. Field Trial of the Enhanced Data Authentication System (EDAS)

    Energy Technology Data Exchange (ETDEWEB)

    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.

  7. Scientific Opinion on field trials for bovine tuberculosis vaccination

    Directory of Open Access Journals (Sweden)

    EFSA Panel on Animal Health and Welfare (AHAW

    2013-12-01

    Full Text Available The opinion provides advice relating to the design of field trials to test the performance of a vaccine for bovine tuberculosis (bTB, along with a test to Detect Infected among Vaccinated Animals (DIVA. The objective of cattle vaccination is to use the vaccine in combination with presently applied control measures within the EU as an aid towards bTB eradication. The ideal field trials for the DIVA test will follow the OIE guidelines for test validation. Any deviations from the ideal trial design in relation to DIVA test performance should be justified, and the bias that may subsequently be introduced should be accounted for. The ideal field trial design for vaccination performance should implement a double-blind randomised test scenario, and allow for known risk factors in the field situation. Any deviations from the ideal trial design in relation to vaccine performance should also be justified and bias that may subsequently be introduced should be accounted for. Relevant risk factors and possible confounders that should be taken into consideration in the design of field trials are described in this opinion. The safety of a candidate vaccine is guaranteed in the registration of a vaccine medication by a competent authority. The field trials will need to fulfil these requirements to prove that the use of this vaccine in the field is safe for both public health and the environment. Some additional remarks regarding the safety of this specific vaccine are included in this opinion.

  8. From concept to content: assessing the implementation fidelity of a chronic care model for frail, older people who live at home.

    OpenAIRE

    Muntinga, M. E.; Leeuwen, K.M. van; Schellevis, F G; Nijpels, G.; Jansen, A.P.D.

    2015-01-01

    Background Implementation fidelity, the degree to which a care program is implemented as intended, can influence program impact. Since results of trials that aim to implement comprehensive care programs for frail, older people have been conflicting, assessing implementation fidelity alongside these trials is essential to differentiate between flaws inherent to the program and implementation issues. This study demonstrates how a theory-based assessment of fidelity can increase insight in the i...

  9. The ONTARGET trial programme

    DEFF Research Database (Denmark)

    Unger, Thomas; Kintscher, Ulrich; Kappert, Kai;

    2009-01-01

    The ONTARGET trial programme tested the effects of the angiotensin AT1 receptor blocker (ARB), telmisartan, alone or in combination with the angiotensin converting enzyme (ACE) inhibitor, ramipril, in more than 25.000 patients at high cardiovascular risk including diabetes on a combined endpoint....... Telmisartan thus proved to be the first and so far the only representative of the ARB class that can be used as an alternative to the "gold standard" ACE-inhibitor, ramipril, in patients at high cardiovascular risk with or without hypertension. © 2009 Bentham Science Publishers Ltd....... consisting of cardiovascular death, non-fatal stroke or myocardial infarction and hospitalisation for congestive heart failure. Patient selection and study procedures followed the previous HOPE trial. In the parallel TRANSCEND study, nearly 6.000 patients, all intolerant to ACE inhibition, were subjected...

  10. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    McAlindon, T. E.; Driban, J. B.; Henrotin, Y.;

    2015-01-01

    members voted we calculated the median score among the nine members of the working group who completed the score. The document includes 25 recommendations regarding randomization, blocking and stratification, blinding, enhancing accuracy of patient-reported outcomes (PRO), selecting a study population and......The goal of this document is to update the original OARSI recommendations specifically for the design, conduct, and reporting of clinical trials that target symptom or structure modification among individuals with knee osteoarthritis (OA). To develop recommendations for the design, conduct, and...... reporting of clinical trials for knee OA we initially drafted recommendations through an iterative process. Members of the working group included representatives from industry and academia. After the working group members reviewed a final draft, they scored the appropriateness for recommendations. After the...

  11. a randomized, controlled trial

    OpenAIRE

    Reinecke, Franziska

    2010-01-01

    The polycystic ovarian syndrome (PCOS) is characterized by hyperandrogenism and associated with obesity and impaired glucose metabolism. Despite the high prevalence of PCOS and the considerable clinical impact, the precise interplay between metabolism and hyperandrogenemia is not entirely clear. To analyse the effects of intravenous lipid and heparin infusion on circulating androgen levels in healthy women, we performed a randomized controlled cross-over trial. 12 healthy young women durin...

  12. Randomised clinical trial

    DEFF Research Database (Denmark)

    Meineche-Schmidt, V.; Christensen, E.; Bytzer, P.

    2011-01-01

    Background: Response to proton pump inhibitor (PPI) treatment in dyspepsia is unpredictable. Aim: To identify symptoms associated with response to esomeprazole in order to target patients for empirical treatment. Methods: Eight hundred and five uninvestigated, primary care patients with upper GI ....... Conclusions In patients with uninvestigated dyspepsia, PPI responders can be reliably identified by a simple pocket chart using symptoms and patient characteristics (ClinicalTrials.gov NCT00318968). © 2010 Blackwell Publishing Ltd....

  13. Effects of patient safety culture interventions on incident reporting in general practice : A cluster randomised trial a cluster randomised trial

    NARCIS (Netherlands)

    Verbakel, Natasha J.; Langelaan, Maaike; Verheij, Theo J M; Wagner, Cordula; Zwart, Dorien L M

    2015-01-01

    Background: A constructive safety culture is essential for the successful implementation of patient safety improvements. Aim: To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. Design and setting: A three-arm cluster randomised trial

  14. Pipeline Decommissioning Trial AWE Berkshire UK - 13619

    Energy Technology Data Exchange (ETDEWEB)

    Agnew, Kieran [AWE, Aldermaston, Reading, RG7 4PR (United Kingdom)

    2013-07-01

    This Paper details the implementation of a 'Decommissioning Trial' to assess the feasibility of decommissioning the redundant pipeline operated by AWE located in Berkshire UK. The paper also presents the tool box of decommissioning techniques that were developed during the decommissioning trial. Constructed in the 1950's and operated until 2005, AWE used a pipeline for the authorised discharge of treated effluent. Now redundant, the pipeline is under a care and surveillance regime awaiting decommissioning. The pipeline is some 18.5 km in length and extends from AWE site to the River Thames. Along its route the pipeline passes along and under several major roads, railway lines and rivers as well as travelling through woodland, agricultural land and residential areas. Currently under care and surveillance AWE is considering a number of options for decommissioning the pipeline. One option is to remove the pipeline. In order to assist option evaluation and assess the feasibility of removing the pipeline a decommissioning trial was undertaken and sections of the pipeline were removed within the AWE site. The objectives of the decommissioning trial were to: - Demonstrate to stakeholders that the pipeline can be removed safely, securely and cleanly - Develop a 'tool box' of methods that could be deployed to remove the pipeline - Replicate the conditions and environments encountered along the route of the pipeline The onsite trial was also designed to replicate the physical prevailing conditions and constraints encountered along the remainder of its route i.e. working along a narrow corridor, working in close proximity to roads, working in proximity to above ground and underground services (e.g. Gas, Water, Electricity). By undertaking the decommissioning trial AWE have successfully demonstrated the pipeline can be decommissioned in a safe, secure and clean manor and have developed a tool box of decommissioning techniques. The tool box of includes

  15. Pipeline Decommissioning Trial AWE Berkshire UK - 13619

    International Nuclear Information System (INIS)

    This Paper details the implementation of a 'Decommissioning Trial' to assess the feasibility of decommissioning the redundant pipeline operated by AWE located in Berkshire UK. The paper also presents the tool box of decommissioning techniques that were developed during the decommissioning trial. Constructed in the 1950's and operated until 2005, AWE used a pipeline for the authorised discharge of treated effluent. Now redundant, the pipeline is under a care and surveillance regime awaiting decommissioning. The pipeline is some 18.5 km in length and extends from AWE site to the River Thames. Along its route the pipeline passes along and under several major roads, railway lines and rivers as well as travelling through woodland, agricultural land and residential areas. Currently under care and surveillance AWE is considering a number of options for decommissioning the pipeline. One option is to remove the pipeline. In order to assist option evaluation and assess the feasibility of removing the pipeline a decommissioning trial was undertaken and sections of the pipeline were removed within the AWE site. The objectives of the decommissioning trial were to: - Demonstrate to stakeholders that the pipeline can be removed safely, securely and cleanly - Develop a 'tool box' of methods that could be deployed to remove the pipeline - Replicate the conditions and environments encountered along the route of the pipeline The onsite trial was also designed to replicate the physical prevailing conditions and constraints encountered along the remainder of its route i.e. working along a narrow corridor, working in close proximity to roads, working in proximity to above ground and underground services (e.g. Gas, Water, Electricity). By undertaking the decommissioning trial AWE have successfully demonstrated the pipeline can be decommissioned in a safe, secure and clean manor and have developed a tool box of decommissioning techniques. The tool box of includes; - Hot tapping - a method

  16. Observational measure of implementation progress in community based settings: The Stages of implementation completion (SIC

    Directory of Open Access Journals (Sweden)

    Brown C

    2011-10-01

    Full Text Available Abstract Background An increasingly large body of research is focused on designing and testing strategies to improve knowledge about how to embed evidence-based programs (EBP into community settings. Development of strategies for overcoming barriers and increasing the effectiveness and pace of implementation is a high priority. Yet, there are few research tools that measure the implementation process itself. The Stages of Implementation Completion (SIC is an observation-based measure that is used to track the time to achievement of key implementation milestones in an EBP being implemented in 51 counties in 53 sites (two counties have two sites in two states in the United States. Methods The SIC was developed in the context of a randomized trial comparing the effectiveness of two implementation strategies: community development teams (experimental condition and individualized implementation (control condition. Fifty-one counties were randomized to experimental or control conditions for implementation of multidimensional treatment foster care (MTFC, an alternative to group/residential care placement for children and adolescents. Progress through eight implementation stages was tracked by noting dates of completion of specific activities in each stage. Activities were tailored to the strategies for implementing the specific EBP. Results Preliminary data showed that several counties ceased progress during pre-implementation and that there was a high degree of variability among sites in the duration scores per stage and on the proportion of activities that were completed in each stage. Progress through activities and stages for three example counties is shown. Conclusions By assessing the attainment time of each stage and the proportion of activities completed, the SIC measure can be used to track and compare the effectiveness of various implementation strategies. Data from the SIC will provide sites with relevant information on the time and

  17. NATO SOCMET trials

    Science.gov (United States)

    Jenden, C. M.

    1993-11-01

    During 1993, Canada, France, Germany and the United Kingdom will be participating in the Smoke and Obscurants Countermeasures Materials Evaluation Tests (SOCMET). The tests will be carried out under the auspices of the NATO Army Armaments Group, AC/225, Panel VI, Sub-Panel 7 whose interests include multispectral smoke screening systems. The tests will comprise two sets of trials; one under cold climate conditions in Quebec, Canada, during February/March 1993 and the other in temperate conditions in Bourges, France during September 1993. This paper provides an insight into the management and aims of SOCMET. The evaluations will be seeking to identify candidate materials which create effective obscurant screens in the visible, infrared and millimetric bands of the electromagnetic spectrum. These materials will be disseminated through a range area dispersal. A key element of the trials will be the evaluation of field test instrumentation which may eventually lead to the development of standardized evaluation techniques. Following the trials, a scientific workshop will be held to review the results. A final report will be presented to NATO which will form the basis of future collaborative developments on multispectral screening systems leading towards standard NATO documentation on smoke and obscurant systems.

  18. A Clinical Trial on Weight Loss among Truck Drivers

    Directory of Open Access Journals (Sweden)

    MS Thiese

    2015-03-01

    Full Text Available Background: The high prevalence of obesity among commercial truck drivers may be related to sedentary nature of the job, lack of healthy eating choices, and lack of exercise. There may be a link between obesity and crash risk, therefore an intervention to reduce obesity in this population is needed.Objective: To assess feasibility of a 12-week weight loss intervention for truck drivers with a weight loss goal of 10% of initial body weight.Methods: Drivers were selected based on age (≥21 years and body mass index (≥30 kg/m2. The drivers participated in a before-after clinical trial. The intervention included a 12-week program that provided information on healthy diet and increasing exercise, and telephone-based coaching using SMART goals. Outcomes included change from baseline in reported energy intake, measured weight, waist, hip, and neck circumference, blood pressure, and point of care capillary blood lipids and hemoglobin A1c. Exit interviews were conducted to gain insight into driver opinions on the program features and usefulness. This study was registered with the NIH Clinical Trials Registry, number NCT02348983.Results: 12 of 13 drivers completed the study. Weight loss was statistically significant (p=0.03. Reported energy (p=0.005, total fat consumption (p=0.04, and saturated fat consumption (p=0.02 intake were also lower after the 12-week intervention. Drivers attributed their weight loss to health coaching and suggested a longer intervention so that they could reach their goal and become accustomed to the changes.Conclusion: This weight loss intervention is feasible for this difficult population. Additional research is needed to compare this intervention with a control group.

  19. Privacy and confidentiality in pragmatic clinical trials.

    Science.gov (United States)

    McGraw, Deven; Greene, Sarah M; Miner, Caroline S; Staman, Karen L; Welch, Mary Jane; Rubel, Alan

    2015-10-01

    With pragmatic clinical trials, an opportunity exists to answer important questions about the relative risks, burdens, and benefits of therapeutic interventions. However, concerns about protecting the privacy of this information are significant and must be balanced with the imperative to learn from the data gathered in routine clinical practice. Traditional privacy protections for research uses of identifiable information rely disproportionately on informed consent or authorizations, based on a presumption that this is necessary to fulfill ethical principles of respect for persons. But frequently, the ideal of informed consent is not realized in its implementation. Moreover, the principle of respect for persons—which encompasses their interests in health information privacy—can be honored through other mechanisms. Data anonymization also plays a role in protecting privacy but is not suitable for all research, particularly pragmatic clinical trials. In this article, we explore both the ethical foundation and regulatory framework intended to protect privacy in pragmatic clinical trials. We then review examples of novel approaches to respecting persons in research that may have the added benefit of honoring patient privacy considerations. PMID:26374682

  20. The impact of trial runs on the acceptability of pigouvian taxes: experimental evidence

    Energy Technology Data Exchange (ETDEWEB)

    Cherry, Todd L.; Kallbekken, Steffen; Kroll, Stephen

    2011-07-01

    This paper examines the political difficulty of enacting welfare-enhancing Pigouvian taxes. Using referenda in a market experiment with externalities, we investigate the effect of trial periods on the acceptability of two theoretically equivalent variants of Pigouvian taxes. While implementing either tax is in subjects material self-interest, we find significant levels of opposition to both tax schemes, though the level differs considerably. Results show that trial runs can overcome initial tax aversion, significantly increasing acceptability. The effect is robust across tax schemes, but a trial with one scheme does not affect the acceptability of the other. Trial periods also mitigate initial biases in preferences of alternative tax schemes. (auth)

  1. Are Clinical Trial Experiences Utilized?: A Differentiated Model of Medical Sites’ Information Transfer Ability

    DEFF Research Database (Denmark)

    Smed, Marie; Schultz, Carsten; Getz, Kenneth A.;

    2015-01-01

    The collaboration with medical professionals in pharmaceutical clinical trials facilitates opportunities to gain valuable market information concerning product functionality issues, as well as issues related to market implementation and adoption. However, previous research on trial management lacks...... a differentiated perspective on the potential for information transfer from site to producer. An exploration of the variation in stickiness of information, and therefore the complexity of information transfer in clinical trials, is the main aim of this study. To further enrich the model of the dispersed sites......, complementary service issues and usability patterns are all significantly more difficult to transfer in clinical trials than issues related to product functionality....

  2. Building a framework for implementing new interventions.

    Science.gov (United States)

    Cogan, Alison M; Blanche, Erna I; Díaz, Jesús; Clark, Florence A; Chun, Sophia

    2014-01-01

    Implementation into real-world practice of interventions previously studied in randomized controlled trials is an ongoing challenge. In this article, we describe the methodology we used for the first phase of a project for the implementation and outcomes assessment of an occupational therapy pressure ulcer prevention intervention for people with spinal cord injury in the Veterans Health Administration. This first phase of the project was guided by practice-based evidence research methodology and resulted in an intervention manual tailored to meet the needs of Veterans and the establishment of a system for documenting and monitoring care processes, patient characteristics, and intervention outcomes. This system, in turn, will provide the data-gathering template for the next phase in which the beneficial effects of the intervention will be assessed. We conclude by recommending that clinicians explore the utility of this approach for the implementation of other novel interventions. PMID:25347759

  3. Gateways to clinical trials.

    Science.gov (United States)

    Tomillero, A; Moral, M A

    2008-10-01

    Gateways to clinical trials is a guide to the most recent trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity(R), the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: (+)-Dapoxetine hydrochloride, (S)-Tenatoprazole sodium salt monohydrate 19-28z, Acotiamide hydrochloride hydrate, ADV-TK, AE-37, Aflibercept, Albinterferon alfa-2b, Aliskiren fumarate, Asenapine maleate, Axitinib; Bavituximab, Becatecarin, beta-1,3/1,6-Glucan, Bevacizumab, Bremelanotide; Calcipotriol/betamethasone dipropionate, Casopitant mesylate, Catumaxomab, CDX-110, Cediranib, CMD-193, Cositecan; Darinaparsin, Denosumab, DP-b99, Duloxetine hydrochloride; E75, Ecogramostim, Elacytarabine, EMD-273063, EndoTAG-1, Enzastaurin hydrochloride, Eplerenone, Eribulin mesilate, Esomeprazole magnesium, Etravirine, Everolimus, Ezetimibe; Faropenem daloxate, Febuxostat, Fenretinide; Ghrelin (human); I-131 ch-TNT-1/B, I-131-3F8, Iclaprim, Iguratimod, Iloperidone, Imatinib mesylate, Inalimarev/Falimarev, Indacaterol, Ipilimumab, Iratumumab, Ispinesib mesylate, Ixabepilone; Lapatinib ditosylate, Laquinimod sodium, Larotaxel dehydrate, Linezolid, LOR-2040; Mapatumumab, MKC-1, Motesanib diphosphate, Mycophenolic acid sodium salt; NK-012; Olanzapine pamoate, Oncolytic HSV, Ortataxel; Paclitaxel nanoparticles, Paclitaxel poliglumex, Paliperidone palmitate, Panitumumab, Patupilone, PCV-9, Pegfilgrastim, Peginterferon alfa-2a, Peginterferon alfa-2b, Pertuzumab, Picoplatin, Pimavanserin tartrate, Pimecrolimus, Plerixafor hydrochloride, PM-02734, Poly I:CLC, PR1, Prasugrel, Pregabalin, Progesterone caproate, Prucalopride, Pumosetrag hydrochloride; RAV-12, RB-006, RB-007, Recombinant human erythropoietin alfa, Rimonabant, Romidepsin; SAR-109659, Satraplatin, Sodium butyrate; Tadalafil, Talampanel, Tanespimycin, Tarenflurbil, Tariquidar

  4. Gateways to clinical trials.

    Science.gov (United States)

    Bayés, M; Rabasseda, X; Prous, J R

    2005-04-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity. prous.com. This issue focuses on the following selection of drugs: ABX-IL-8, Acclaim, adalimumab, AGI-1067, alagebrium chloride, alemtuzumab, Alequel, Androgel, anti-IL-12 MAb, AOD-9604, aripiprazole, atomoxetine hydrochloride; Biphasic insulin aspart, bosentan, botulinum toxin type B, bovine lactoferrin, brivudine; Cantuzumab mertansine, CB-1954, CDB-4124, CEA-TRICOM, choriogonadotropin alfa, cilansetron, CpG-10101, CpG-7909, CTL-102, CTL-102/CB-1954; DAC:GRF, darbepoetin alfa, davanat-1, decitabine, del-1 Genemedicine, dexanabinol, dextofisopam, dnaJP1, dronedarone hydrochloride, dutasteride; Ecogramostim, eletriptan, emtricitabine, EPI-hNE-4, eplerenone, eplivanserin fumarate, erlotinib hydrochloride, ertapenem sodium, escitalopram oxalate, esomeprazole magnesium, etoricoxib, ezetimibe; Falecalcitriol, fingolimod hydrochloride; Gepirone hydrochloride; HBV-ISS, HSV-2 theracine, human insulin; Imatinib mesylate, Indiplon, insulin glargine, ISAtx-247; L612 HuMAb, levodopa/carbidopa/entacapone, lidocaine/prilocaine, LL-2113AD, lucinactant, LY-156735; Meclinertant, metelimumab, morphine hydrochloride, morphine-6-glucuronide; Natalizumab, nimotuzumab, NX-1207, NYVAC-HIV C; Omalizumab, onercept, osanetant; PABA, palosuran sulfate, parathyroid hormone (human recombinant), parecoxib sodium, PBI-1402, PCK-3145, peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b/ribavirin, pemetrexed disodium, pimecrolimus, PINC, pregabalin; Ramelteon, rasagiline mesilate, rasburicase, rimonabant hydrochloride, RO-0098557, rofecoxib, rosiglitazone maleate/metformin hydrochloride; Safinamide mesilate, SHL-749, sitaxsentan sodium, sparfosic acid, SprayGel, squalamine, St. John's Wort

  5. Gateways to clinical trials.

    Science.gov (United States)

    Tomillero, A; Moral, M A

    2010-11-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Thomson Reuters Integrity(SM), the drug discovery and development portal, http://www.thomsonreutersintegrity.com. This issue focuses on the following selection of drugs: Abatacept, Adalimumab, AdCD40L, Adefovir, Aleglitazar, Aliskiren fumarate, AM-103, Aminolevulinic acid methyl ester, Amlodipine, Anakinra, Aprepitant, Aripiprazole, Atazanavir sulfate, Axitinib; Belimumab, Bevacizumab, Bimatoprost, Bortezomib, Bupropion/naltrexone; Calcipotriol/betamethasone dipropionate, Certolizumab pegol, Ciclesonide, CYT-997; Darbepoetin alfa, Darunavir, Dasatinib, Desvenlafaxine succinate, Dexmethylphenidate hydrochloride cogramostim; Eltrombopag olamine, Emtricitabine, Escitalopram oxalate, Eslicarbazepine acetate, Eszopiclone, Etravirine, Everolimus-eluting coronary stent, Exenatide, Ezetimibe; Fenretinide, Filibuvir, Fludarabine; Golimumab; Hepatitis B hyperimmunoglobulin, HEV-239, HP-802-247, HPV-16/18 AS04, HPV-6/11/16/18, Human albumin, Human gammaglobulin; Imatinib mesylate, Inotuzumab ozogamicin, Invaplex 50 vaccine; Lapatinib ditosylate, Lenalidomide, Liposomal doxorubicin, Lopinavir, Lumiliximab, LY-686017; Maraviroc, Mecasermin rinfabate; Narlaprevir; Ocrelizumab, Oral insulin, Oritavancin, Oxycodone hydrochloride/naloxone; Paclitaxel-eluting stent, Palonosetron hydrochloride, PAN-811, Paroxetine, Pazopanib hydrochloride, Peginterferon alfa-2a, Peginterferon alfa-2b, Pemetrexed disodium, Pertuzumab, Pitavastatin calcium, Posaconazole, Pregabalin, Prucalopride succinate; Raltegravir potassium, Ranibizumab, RHAMM R3 peptide, Rosuvastatin calcium; Salclobuzic acid sodium salt, SCY-635, Selenate sodium, Semapimod hydrochloride, Silodosin, Siltuximab, Silybin, Sirolimus-eluting stent, SIR-Spheres, Sunitinib malate; Tapentadol hydrochloride, Tenofovir disoproxil

  6. Complexity of Strong Implementability

    CERN Document Server

    Thielen, Clemens

    2009-01-01

    We consider the question of implementability of a social choice function in a classical setting where the preferences of finitely many selfish individuals with private information have to be aggregated towards a social choice. This is one of the central questions in mechanism design. If the concept of weak implementation is considered, the Revelation Principle states that one can restrict attention to truthful implementations and direct revelation mechanisms, which implies that implementability of a social choice function is easy to check. For the concept of strong implementation, however, the Revelation Principle becomes invalid, and the complexity of deciding whether a given social choice function is strongly implementable has been open so far. In this paper, we show by using methods from polyhedral theory that strong implementability of a social choice function can be decided in polynomial space and that each of the payments needed for strong implementation can always be chosen to be of polynomial encoding...

  7. Technology Implementation Plan

    DEFF Research Database (Denmark)

    Jensen, Karsten Ingerslev; Schultz, Jørgen Munthe

    The Technology Implementation Plan (TIP) describes the main project results and the intended future use. The TIP is confidential.......The Technology Implementation Plan (TIP) describes the main project results and the intended future use. The TIP is confidential....

  8. TECHNOLOGICAL IMPLEMENTATION PLAN

    DEFF Research Database (Denmark)

    Bellini, Anna

    2004-01-01

    This document has the purpose to describe the technological implementation plan in the IDEAL project.......This document has the purpose to describe the technological implementation plan in the IDEAL project....

  9. Implementing Development Initiatives

    OpenAIRE

    Jamal Khan

    1999-01-01

    Implementation is at the core of all development initiatives and strategies and experience has shown that there exists a gap between formulation and implementation. This paper focuses on the attempts for implementing initiatives for promoting decentralised management and increased participation in developing countries arid identifies the obstacles in the process. It is generally seen that problems of implementation cannot be entirely anticipated and planned for in advance. Also decentralisati...

  10. The decentralized implementability problem

    OpenAIRE

    Fiaz, Shaik; Trentelman, H.L.

    2010-01-01

    This paper deals with the problems of decentralized implementability and decentralized regular implementability in the context of finite-dimensional linear differential system behaviors. Given a plant behavior with a pre-specified partition of the system variable and a desired behavior, the problem of decentralized implementability is to find a controller which is decentralized with respect to the given partition and implements (regularly) the desired behavior with respect to the plant. In th...

  11. Comparison of Pre-Processing and Classification Techniques for Single-Trial and Multi-Trial P300-Based Brain Computer Interfaces

    Directory of Open Access Journals (Sweden)

    Chanan S. Syan

    2010-01-01

    Full Text Available The P300 component of Event Related Brain Potentials (ERP is commonly used in Brain Computer Interfaces (BCI to translate the intentions of an individual into commands for external devices. The P300 response, however, resides in a signal environment of high background noise. Consequently, the main problem in developing a P300-based BCI lies in identifying the P300 response in the presence of this noise. Traditionally, attenuating the background activity of P300 data is done by averaging multiple trials of recorded signals. This method, though effective, suffers two drawbacks. First, collecting multiple trials of data is time consuming and delays the BCI response. Second, latency distortions may appear in the averaged result due to variable time-locking of the P300 in the individual trials. Problem statement: The use of single-trial P300 data overcomes both these shortcomings. However, single-trial data must be properly denoised to allow for reliable BCI operation. Single-trial P300-based BCIs have been implemented using a variety of signal processing techniques and classification methodologies. However, comparing the accuracies of these systems to other multi-trial systems is likely to include the comparison of more than just the trial format (single-trial/multi-trial as the data quality and recording circumstances are likely to be dissimilar. Approach: This issue was directly addressed by comparing the performance comparison of three different preprocessing agents and three classification methodologies on the same data set over both the single-trial and multi-trial settings. The P300 data set of BCI Competition II was used to facilitate this comparison. Results: The LDA classifier exhibited the best performance in classifying unseen P300 spatiotemporal features in both the single-trial (74.19% and multi-trial format (100%. It is also very efficient in terms of computational and memory requirements. Conclusion: This study can serve as a general

  12. Implementation of Axiomatic Language

    OpenAIRE

    Wilson, Walter W.

    2011-01-01

    This report summarizes a PhD research effort to implement a type of logic programming language called "axiomatic language". Axiomatic language is intended as a specification language, so its implementation involves the transformation of specifications to efficient algorithms. The language is described and the implementation task is discussed.

  13. Comparison communities in a cluster randomised trial innovate in response to 'being controlled'.

    Science.gov (United States)

    Hawe, Penelope; Riley, Therese; Gartrell, Alexandra; Turner, Karen; Canales, Claudia; Omstead, Darlene

    2015-05-01

    We conducted qualitative interviews among primary health care teams and community agencies in eight communities in Victoria, Australia which had (1) agreed to be part of a universal primary care and community development intervention to reduce post natal depression and promote maternal health; and (2) were randomised to the comparison arm. The purpose was to document their experience with and interpretation of the trial. Although 'control' in a controlled trial refers to the control of confounding of the trial result by factors other than allocation to the intervention, participants interpreted 'control' to mean restrictions on what they were allowed to do during the trial period. They had agreed not to use the Edinburgh Post Natal Depression Scale or the SF 36 in clinical practice and not to implement any of the elements of the intervention. We found that no elements of the intervention were implemented. However, the extension of the trial from three to five years made the trial agreement a strain. The imposition of trial conditions also encouraged a degree of lateral thinking and innovation in service delivery (quality improvement). This may have potentially contributed to the null trial results. The observations invite interrogation of intervention theory and consequent rethinking of the way contamination in a cluster trial is defined. PMID:25863725

  14. Gateways to clinical trials.

    Science.gov (United States)

    Bayes, M; Rabasseda, X; Prous, J R

    2002-01-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses, which has been retrieved from the Clinical Studies knowledge area of Prous Science Integrity, the world's first drug discovery and development portal, providing information on study design, treatments, conclusions and references. This issue focuses on the following selection of drugs: Abacavir sulfate; abciximab; abetimus sodium; adalimumab; aldesleukin; almotriptan; alteplase; amisulpride; amitriptyline hydrochloride; amoxicillin trihydrate; atenolol; atorvastatin calcium; atrasentan; Beclometasone dipropionate; bosentan; Captopril; ceftriaxone sodium; cerivastatin sodium; cetirizine hydrochloride; cisplatin; citalopram hydrobromide; Dalteparin sodium; darusentan; desirudin; digoxin; Efalizumab; enoxaparin sodium; ertapenem sodium; esomeprazole magnesium; estradiol; ezetimibe; Famotidine; farglitazar; fluorouracil; fluticasone propionate; fosamprenavir sodium; Glibenclamide; glucosamine sulfate; Heparin sodium; HSPPC-96; hydrochlorothiazide; Imatinib mesilate; implitapide; Lamivudine; lansoprazole; lisinopril; losartan potassium; l-Propionylcarnitine; Melagatran; metformin hydrochloride; methotrexate; methylsulfinylwarfarin; Nateglinide; norethisterone; Olmesartan medoxomil; omalizumab; omapatrilat; omeprazole; oseltamivir phosphate; oxatomide; Pantoprazole; piperacillin sodium; pravastatin sodium; Quetiapine hydrochloride; Rabeprazole sodium; raloxifene hydrochloride; ramosetron hydrochloride; ranolazine; rasburicase; reboxetine mesilate; recombinant somatropin; repaglinide; reteplase; rosiglitazone; rosiglitazone maleate; rosuvastatin calcium; Sertraline; simvastatin; sumatriptan succinate; Tazobactam sodium; tenecteplase; tibolone; tinidazole; tolterodine tartrate; troglitazone; Uniprost; Warfarin sodium; Ximelagatran. PMID:11980386

  15. Japan nuclear ship sea trial

    Energy Technology Data Exchange (ETDEWEB)

    Yamazaki, Hiroshi; Kitamura, Toshikatus; Mizushima, Toshihiko [Japan Atomic Energy Research Inst., Mutsu, Aomori (Japan). Mutsu Establishment] [and others

    1992-01-01

    The sea trial of the first Japan nuclear Ship `MUTSU` was conducted from the end of October to December in 1990. The purpose of the sea trial was to verify the nuclear propulsive performances and maneuverabilities. The present report describes the results of the sea trial. These results are classified into four items: 1. Speed test and engineering performance tests 2. Maneuvering performance tests 3. Vibration tests 4. Other tests. Acceptable performances were demonstrated, as expected in the original design. The experience of the use of the Global Positioning System (GPS), which were newly adopted for the sea trial, is also reported. (author).

  16. Japan nuclear ship sea trial

    Energy Technology Data Exchange (ETDEWEB)

    Yamazaki, Hiroshi; Kitamura, Toshikatus; Mizushima, Toshihiko (Japan Atomic Energy Research Inst., Mutsu, Aomori (Japan). Mutsu Establishment) (and others)

    1992-01-01

    The sea trial of the first Japan nuclear Ship 'MUTSU' was conducted from the end of October to December in 1990. The purpose of the sea trial was to verify the nuclear propulsive performances and maneuverabilities. The present report describes the results of the sea trial. These results are classified into four items: 1. Speed test and engineering performance tests 2. Maneuvering performance tests 3. Vibration tests 4. Other tests. Acceptable performances were demonstrated, as expected in the original design. The experience of the use of the Global Positioning System (GPS), which were newly adopted for the sea trial, is also reported. (author).

  17. Japan nuclear ship sea trial

    International Nuclear Information System (INIS)

    The sea trial of the first Japan nuclear Ship 'MUTSU' was conducted from the end of October to December in 1990. The purpose of the sea trial was to verify the nuclear propulsive performances and maneuverabilities. The present report describes the results of the sea trial. These results are classified into four items: 1. Speed test and engineering performance tests 2. Maneuvering performance tests 3. Vibration tests 4. Other tests. Acceptable performances were demonstrated, as expected in the original design. The experience of the use of the Global Positioning System (GPS), which were newly adopted for the sea trial, is also reported. (author)

  18. An Approach for Dynamic Optimization of Prevention Program Implementation in Stochastic Environments

    Science.gov (United States)

    Kang, Yuncheol; Prabhu, Vittal

    The science of preventing youth problems has significantly advanced in developing evidence-based prevention program (EBP) by using randomized clinical trials. Effective EBP can reduce delinquency, aggression, violence, bullying and substance abuse among youth. Unfortunately the outcomes of EBP implemented in natural settings usually tend to be lower than in clinical trials, which has motivated the need to study EBP implementations. In this paper we propose to model EBP implementations in natural settings as stochastic dynamic processes. Specifically, we propose Markov Decision Process (MDP) for modeling and dynamic optimization of such EBP implementations. We illustrate these concepts using simple numerical examples and discuss potential challenges in using such approaches in practice.

  19. Implementation of the Additional Protocol in Japan

    International Nuclear Information System (INIS)

    The Additional Protocol between Japan and the IAEA entered into force in December 1999. To come into force a series of implementation trials of Additional Protocol was carried out at two Japanese representative nuclear research centers, i.e. Tokai Research Establishment of Japan Atomic Energy Research Institute (JAERI) and Oarai Engineering Center of Japan Nuclear Fuel Cycle Development Institute (JNC). These trials were proposed by Japan and were conducted in cooperation with the IAEA Secretariat. In addition, Japan amended 'the Law for the Regulation of Reactors etc.', to collect adequate information to submit to the IAEA, to arrange the surrounding for the complementary access, etc. In addition, Japan Submitted the Initial Declaration of the Additional Protocol within 180 days of the entry into force of the Protocol, in the middle of June, 2000

  20. Implementing Collaborative Learning Methods in the Political Science Classroom

    Science.gov (United States)

    Wolfe, Angela

    2012-01-01

    Collaborative learning is one, among other, active learning methods, widely acclaimed in higher education. Consequently, instructors in fields that lack pedagogical training often implement new learning methods such as collaborative learning on the basis of trial and error. Moreover, even though the benefits in academic circles are broadly touted,…

  1. The implementation of verbal instructions : An fMRI study

    NARCIS (Netherlands)

    Hartstra, E.; Kühn, S.; Verguts, T.; Brass, M.

    2011-01-01

    In everyday life, our actions are often guided by verbal instructions. Usually, we can implement such instructions immediately without trial and error learning. This raises the fundamental question how verbal instructions are transformed into efficient motor behavior. The aim of this study was to ga

  2. Implementation of the external cephalic version in breech delivery. Dutch national implementation study of external cephalic version

    Directory of Open Access Journals (Sweden)

    Papatsonis Dimitri N

    2010-05-01

    Full Text Available Abstract Background Breech presentation occurs in 3 to 4% of all term pregnancies. External cephalic version (ECV is proven effective to prevent vaginal breech deliveries and therefore it is recommended by clinical guidelines of the Royal Dutch Organisation for Midwives (KNOV and the Dutch Society for Obstetrics and Gynaecology (NVOG. Implementation of ECV does not exceed 50 to 60% and probably less. We aim to improve the implementation of ECV to decrease maternal and neonatal morbidity and mortality due to breech presentations. This will be done by defining barriers and facilitators of implementation of ECV in the Netherlands. An innovative implementation strategy will be developed based on improved patient counselling and thorough instructions of health care providers for counselling. Method/design The ultimate purpose of this implementation study is to improve counselling of pregnant women and information of clinicians to realize a better implementation of ECV. The first phase of the project is to detect the barriers and facilitators of ECV. The next step is to develop an implementation strategy to inform and counsel pregnant women with a breech presentation, and to inform and educate care providers. In the third phase, the effectiveness of the developed implementation strategy will be evaluated in a randomised trial. The study population is a random selection of midwives and gynaecologists from 60 to 100 hospitals and practices. Primary endpoints are number of counselled women. Secondary endpoints are process indicators, the amount of fetes in cephalic presentation at birth, complications due to ECV, the number of caesarean sections and perinatal condition of mother and child. Cost effectiveness of the implementation strategy will be measured. Discussion This study will provide evidence for the cost effectiveness of a structural implementation of external cephalic versions to reduce the number of breech presentations at term. Trial

  3. The FOCUS trial

    DEFF Research Database (Denmark)

    Glenthøj, Louise B; Fagerlund, Birgitte; Randers, Lasse;

    2015-01-01

    BACKGROUND: Cognitive deficits are a distinct feature among people at ultra-high risk (UHR) for psychosis and pose a barrier to functional recovery. Insufficient evidence exists on how to ameliorate these cognitive deficits in patients at UHR for psychosis and hence improve daily living and quality...... the cognitive training to their everyday lives. Follow-up assessments will be conducted at 6 and 12 months after randomisation. The primary outcome is the composite score on the Brief Assessment of Cognition in Schizophrenia at cessation of treatment after 6 months. Secondary outcomes are social and......-blinded clinical trial enrolling 126 patients meeting the standardised criteria of being at UHR for psychosis. Patients are recruited from psychiatric in- and outpatient facilities in the Copenhagen catchment area. Patients are randomised to one of the two treatment arms: cognitive remediation plus standard...

  4. 地方法院實施「案件流程管理」制度對於妥速審判之回應──以臺灣新竹地方法院刑事審前中心為例 District Court Implement Case Flow Management System Responded to Properly and Speedy Trial ─ Centred on Taiwan Hsinchu District Court Criminal Pretrial Center

    Directory of Open Access Journals (Sweden)

    邱忠義 Jong-Yi Chiou

    2013-06-01

    Full Text Available 本文試圖跳脫傳統詮釋論之法學方法,以量化及質性研究之法學實證研究方法,並利用平衡計分卡(BSC)分析法院推行「刑事案件流程管理」制度,在財務、顧客、內部程序及學習成長等四構面之因果關係,嘗試建構推行新制之願景與策略,再經由策略地圖結合關鍵績效指標(KPI)之展開,逐一分析法院試辦「案件流程管理」制度之成效,是否達到各項預設之關鍵績效指標。並以研究結果提供司法院精進此制度成效之參考,盼能推行全國一體實施,回應民眾對於妥與速之審判要求,以提升信任度,並營造法官合理審判環境,以共創雙贏。 This article attempts to jump off the traditional interpretation on the Law changed to the Law of empirical research to quantitative research and qualitative research, and use the Balanced Scorecard (BSC to analyze the court the implementation of case flow management system in the financial, customers, internal processes and learning and growth the causal relationship of the four dimensions, try to construct a vision and strategy of the implementation of the new system, combined with the commencement of key performance indicators (KPI through strategic map, to analyze the court “Criminal case flow Management” the effectiveness of the system, can achieve the various preset KPI. And results provided to the Judicial Yuan for the future extend into a system of reference. This article and hope that the introduction of a national and universal implementation in response to the public “properly with the speed of the trial” requirement (trust enhancement, and to create a reasonable judge trial, in order to create win-win.

  5. Defendants' Rights in Criminal Trials.

    Science.gov (United States)

    Martin, Ralph C., II; Keeley, Elizabeth

    1997-01-01

    Reviews the protections afforded by the Constitution for defendants in criminal trials. These include the right to a jury trial (in cases of possible incarceration), an impartial jury, and the requirement of a unanimous verdict. Defends the use of plea bargaining as essential to an efficient criminal justice system. (MJP)

  6. Randomized clinical trials in HEPATOLOGY

    DEFF Research Database (Denmark)

    Kjaergard, L L; Nikolova, D; Gluud, C

    1999-01-01

    Evidence shows that the quality of randomized clinical trials (RCTs) affects estimates of intervention efficacy, which is significantly exaggerated in low-quality trials. The present study examines the quality of all 235 RCTs published in HEPATOLOGY from the initiation in 1981 through August 1998...

  7. Topics in clinical trial management

    NARCIS (Netherlands)

    B.A. Kirwan (Bridget Anne)

    2004-01-01

    textabstractThe aim of this thesis is to show how clinical trial conduct can be managed while respecting the underlying scientific principles. Chapter 2 describes the main results of PICO (PImobendan in COngestive heart failure), a trial which investigated a positive inotropic agent in patients with

  8. Market trials of irradiated chicken

    International Nuclear Information System (INIS)

    The potential market for irradiated chicken breasts was investigated using a mail survey and a retail trial. Results from the mail survey suggested a significantly higher level of acceptability of irradiated chicken than did the retail trial. A subsequent market experiment involving actual purchases showed levels of acceptability similar to that of the mail survey when similar information about food irradiation was provided

  9. Using a business model approach and marketing techniques for recruitment to clinical trials

    Directory of Open Access Journals (Sweden)

    Knight Rosemary

    2011-03-01

    Full Text Available Abstract Randomised controlled trials (RCTs are generally regarded as the gold standard for evaluating health care interventions. The level of uncertainty around a trial's estimate of effect is, however, frequently linked to how successful the trial has been in recruiting and retaining participants. As recruitment is often slower or more difficult than expected, with many trials failing to reach their target sample size within the timescale and funding originally envisaged, the results are often less reliable than they could have been. The high number of trials that require an extension to the recruitment period in order to reach the required sample size potentially delays the introduction of more effective therapies into routine clinical practice. Moreover, it may result in less research being undertaken as resources are redirected to extending existing trials rather than funding additional studies. Poor recruitment to publicly-funded RCTs has been much debated but there remains remarkably little clear evidence as to why many trials fail to recruit well, which recruitment methods work, in which populations and settings and for what type of intervention. One proposed solution to improving recruitment and retention is to adopt methodology from the business world to inform and structure trial management techniques. We review what is known about interventions to improve recruitment to trials. We describe a proposed business approach to trials and discuss the implementation of using a business model, using insights gained from three case studies.

  10. Using a business model approach and marketing techniques for recruitment to clinical trials.

    Science.gov (United States)

    McDonald, Alison M; Treweek, Shaun; Shakur, Haleema; Free, Caroline; Knight, Rosemary; Speed, Chris; Campbell, Marion K

    2011-01-01

    Randomised controlled trials (RCTs) are generally regarded as the gold standard for evaluating health care interventions. The level of uncertainty around a trial's estimate of effect is, however, frequently linked to how successful the trial has been in recruiting and retaining participants. As recruitment is often slower or more difficult than expected, with many trials failing to reach their target sample size within the timescale and funding originally envisaged, the results are often less reliable than they could have been. The high number of trials that require an extension to the recruitment period in order to reach the required sample size potentially delays the introduction of more effective therapies into routine clinical practice. Moreover, it may result in less research being undertaken as resources are redirected to extending existing trials rather than funding additional studies.Poor recruitment to publicly-funded RCTs has been much debated but there remains remarkably little clear evidence as to why many trials fail to recruit well, which recruitment methods work, in which populations and settings and for what type of intervention. One proposed solution to improving recruitment and retention is to adopt methodology from the business world to inform and structure trial management techniques.We review what is known about interventions to improve recruitment to trials. We describe a proposed business approach to trials and discuss the implementation of using a business model, using insights gained from three case studies. PMID:21396088

  11. Patient-reported outcome (PRO assessment in clinical trials: a systematic review of guidance for trial protocol writers.

    Directory of Open Access Journals (Sweden)

    Melanie Calvert

    Full Text Available Evidence suggests there are inconsistencies in patient-reported outcome (PRO assessment and reporting in clinical trials, which may limit the use of these data to inform patient care. For trials with a PRO endpoint, routine inclusion of key PRO information in the protocol may help improve trial conduct and the reporting and appraisal of PRO results; however, it is currently unclear exactly what PRO-specific information should be included. The aim of this review was to summarize the current PRO-specific guidance for clinical trial protocol developers.We searched the MEDLINE, EMBASE, CINHAL and Cochrane Library databases (inception to February 2013 for PRO-specific guidance regarding trial protocol development. Further guidance documents were identified via Google, Google scholar, requests to members of the UK Clinical Research Collaboration registered clinical trials units and international experts. Two independent investigators undertook title/abstract screening, full text review and data extraction, with a third involved in the event of disagreement. 21,175 citations were screened and 54 met the inclusion criteria. Guidance documents were difficult to access: electronic database searches identified just 8 documents, with the remaining 46 sourced elsewhere (5 from citation tracking, 27 from hand searching, 7 from the grey literature review and 7 from experts. 162 unique PRO-specific protocol recommendations were extracted from included documents. A further 10 PRO recommendations were identified relating to supporting trial documentation. Only 5/162 (3% recommendations appeared in ≥50% of guidance documents reviewed, indicating a lack of consistency.PRO-specific protocol guidelines were difficult to access, lacked consistency and may be challenging to implement in practice. There is a need to develop easily accessible consensus-driven PRO protocol guidance. Guidance should be aimed at ensuring key PRO information is routinely included in

  12. Open SHMEM Reference Implementation

    Energy Technology Data Exchange (ETDEWEB)

    2016-05-12

    OpenSHMEM is an effort to create a specification for a standardized API for parallel programming in the Partitioned Global Address Space. Along with the specification the project is also creating a reference implementation of the API. This implementation attempts to be portable, to allow it to be deployed in multiple environments, and to be a starting point for implementations targeted to particular hardware platforms. It will also serve as a springboard for future development of the API.

  13. Complexity of Strong Implementability

    Directory of Open Access Journals (Sweden)

    Clemens Thielen

    2009-09-01

    Full Text Available We consider the question of implementability of a social choice function in a classical setting where the preferences of finitely many selfish individuals with private information have to be aggregated towards a social choice. This is one of the central questions in mechanism design. If the concept of weak implementation is considered, the Revelation Principle states that one can restrict attention to truthful implementations and direct revelation mechanisms, which implies that implementability of a social choice function is easy to check. For the concept of strong implementation, however, the Revelation Principle becomes invalid, and the complexity of deciding whether a given social choice function is strongly implementable has been open so far. In this paper, we show by using methods from polyhedral theory that strong implementability of a social choice function can be decided in polynomial space and that each of the payments needed for strong implementation can always be chosen to be of polynomial encoding length. Moreover, we show that strong implementability of a social choice function involving only a single selfish individual can be decided in polynomial time via linear programming.

  14. [Difficulties with conducting clinical trials in France].

    Science.gov (United States)

    Zannad, F; Plétan, Y

    2001-01-01

    France ranks third among European countries as regards the level of investment in clinical R&D and, overall, accounts for a contributive effort proportional to the size of its population and pharmaceutical market respectively. However, there is a trend for phase II and III studies to become proportionally fewer than in the past, while the number of phase IV studies is increasing. In a growing proportion of the mega-trials, which are instrumental for establishing evidence-based practice, French experts, investigators and, even more seriously, French patients, are insufficiently represented. Though studies in France are initiated relatively fast due to a clear regulatory framework and perform equally well as far as quantitative and qualitative factors are concerned, compared with most European countries involved in clinical research the costs incurred per completed patient are higher than those recorded in the other countries. Academic research shares most of these constraints and suffers from a lack of financial and human resources, while it faces additional delays in implementing studies because of longer administrative processes. Given the stakes in play, specific solutions should be implemented to maintain and further develop French competitiveness in clinical R&D. At the patient level, positive perception and awareness of the usefulness and safety of participating in clinical trials need to be emphasized. Education at the school level and using the lay media should be developed. Intervention of institutional and government officials is much needed. Direct patient recruitment should be developed through advertisement and the Internet, as well as within doctors' offices and through collaboration with patients' organizations. Patient information and consent forms should be made much simpler than those imposed within the framework of global studies because of FDA requirements. The French health system discourages the recruitment of patients by investigators who are

  15. The Effect of n-3 Polyunsaturated Fatty Acid Supplementation on Androgen Status in Patients with Polycystic Ovary Syndrome: A Systematic Review and Meta-Analysis of Clinical Trials.

    Science.gov (United States)

    Hajishafiee, M; Askari, G; Iranj, B; Ghiasvand, R; Bellissimo, N; Totosy de Zepetnek, J; Salehi-Abargouei, A

    2016-05-01

    The anti-androgenic role of n-3 polyunsaturated fatty acids (PUFAs) among patients with polycystic ovary syndrome (PCOS) has recently been proposed. The present study aimed to systematically review clinical trials assessing the effects of n-3 PUFAs consumption on androgen status among adult females with PCOS. PubMed, ISI Web of Science, Google Scholar, and Scopus were searched up to December 2015. Clinical investigations assessing the effect of n-3 PUFAs on adult females with PCOS were included. Mean±standard deviation of change in serum total testosterone, sex hormone binding globulin (SHBG), and dehydroepiandrostrone sulfate (DHEAS) were extracted. Eight clinical trials with 298 participants were eligible. Meta-analysis showed that n-3 PUFAs supplementation marginally reduces total testosterone (mean difference [MD]: - 0.19 nmol/l; 95% CI: - 0.39 to 0.00; p=0.054), but not SHBG (MD: 1.75 nmol/l; 95% CI: -0.51 to 4.01; p=0.129) or serum DHEAS levels (Hedes' g: -0.11 nmol/l; 95% CI: -0.29 to 0.06; p=0.19) among adult females with PCOS. Subgroup analyses showed that only before-after studies (Hedges' g: 0.15; 95% CI: -0.27 to -0.04; p=0.01) and long-term interventions (>6 weeks) (Hedges' g: -0.17; 95% CI, -0.29 to -0.05; p=0.004) had reducing effects on serum DHEAS levels. The majority of long-term trials utilized a single group design (no control group). It does not appear that n-3 PUFAs supplementation significantly affects the androgenic profile of females with PCOS; however, some before-after and long-term intervention studies show reduced DHEAS levels. Future studies incorporating double blinded placebo controlled clinical trials with long follow-up periods are warranted. PMID:27077458

  16. Clinical Trials | Division of Cancer Prevention

    Science.gov (United States)

    Information about actively enrolling, ongoing, and completed clinical trials of cancer prevention, early detection, and supportive care, including phase I, II, and III agent and action trials and clinical trials management. |

  17. Challenges with participant reimbursement: experiences from a post-trial access study.

    Science.gov (United States)

    Mngadi, Kathryn Therese; Frohlich, Janet; Montague, Carl; Singh, Jerome; Nkomonde, Nelisiwe; Mvandaba, Nomzamo; Ntombeka, Fanelesibonge; Luthuli, Londiwe; Abdool Karim, Quarraisha; Mansoor, Leila

    2015-11-01

    Reimbursement of trial participants remains a frequently debated issue, with specific guidance lacking. Trials combining post-trial access and implementation science may necessitate new strategies and models. CAPRISA 008, a post-trial access study testing the feasibility of using family planning services to rollout a prelicensure HIV prevention intervention, tried to balance the real-life scenario of no reimbursement for attendance at public sector clinics with that of a trial including some visits that focused on research procedures and others that focused on standard of care procedures. A reduced reimbursement was offered for 'standard of care' visits, meant primarily to cover transport costs to and from the clinic only. This impacted negatively on accrual, retention and participant morale, primarily due to the protracted delay in regulatory approval, during which time, the costs of living, including travel costs had increased. Relevant guidelines were reviewed and institutional policy was updated to incorporate the South African National Health Research Ethics Committee guidelines on reimbursement (taking into account participant time, travel and inconvenience). The reimbursement amount for 'standard of care' visits was increased accordingly. The question remains whether a trial that combines post-trial access with implementation science, with clear benefits for the participants and the provision of above standard medical care, should have reimbursement rates that approach those of a proof-of-concept trial, for 'standard of care' visits. PMID:26392172

  18. Gateways to clinical trials.

    Science.gov (United States)

    Bayés, M; Rabasseda, X; Prous, J R

    2005-06-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: Abiraterone acetate, acyline, adalimumab, adenosine triphosphate, AEE-788, AIDSVAX gp120 B/B, AK-602, alefacept, alemtuzumab, alendronic acid sodium salt, alicaforsen sodium, alprazolam, amdoxovir, AMG-162, aminolevulinic acid hydrochloride, aminolevulinic acid methyl ester, aminophylline hydrate, anakinra, anecortave acetate, anti-CTLA-4 MAb, APC-8015, aripiprazole, aspirin, atazanavir sulfate, atomoxetine hydrochloride, atorvastatin calcium, atrasentan, AVE-5883, AZD-2171; Betamethasone dipropionate, bevacizumab, bimatoprost, biphasic human insulin (prb), bortezomib, BR-A-657, BRL-55730, budesonide, busulfan; Calcipotriol, calcipotriol/betamethasone dipropionate, calcium folinate, capecitabine, capravirine, carmustine, caspofungin acetate, cefdinir, certolizumab pegol, CG-53135, chlorambucil, ciclesonide, ciclosporin, cisplatin, clofarabine, clopidogrel hydrogensulfate, clozapine, co-trimoxazole, CP-122721, creatine, CY-2301, cyclophosphamide, cypher, cytarabine, cytolin; D0401, darbepoetin alfa, darifenacin hydrobromide, DASB, desipramine hydrochloride, desloratadine, desvenlafaxine succinate, dexamethasone, didanosine, diquafosol tetrasodium, docetaxel, doxorubicin hydrochloride, drotrecogin alfa (activated), duloxetine hydrochloride, dutasteride; Ecallantide, efalizumab, efavirenz, eletriptan, emtricitabine, enfuvirtide, enoxaparin sodium, estramustine phosphate sodium, etanercept, ethinylestradiol, etonogestrel, etonogestrel/ethinylestradiol, etoposide, exenatide; Famciclovir, fampridine, febuxostat, filgrastim, fludarabine phosphate, fluocinolone acetonide, fluorouracil, fluticasone propionate

  19. Study protocol of an economic evaluation of an enhanced implementation strategy for the treatment of low back pain in general practice

    DEFF Research Database (Denmark)

    Jensen, Cathrine; Riis, Allan; Pedersen, Kjeld Møller;

    2014-01-01

    Background: In Denmark, guidelines on low back pain management are currently being implemented; in association with this, a clinical trial is conducted. A health economic evaluation is carried out alongside the clinical trial to assess the cost-effectiveness of an extended implementation strategy...

  20. IPAS Implementation Handbook

    Science.gov (United States)

    Brooks, D. Christopher

    2014-01-01

    While the use of analytics to promote student success is gaining in popularity, basic questions about what IPAS is and the issues institutions face during implementation and integration. The "IPAS Implementation Handbook" catalogs the experiences, observations, and practical advice from 19 institutions engaged in IPAS implementation…

  1. Measuring Curriculum Implementation

    Science.gov (United States)

    Huntley, Mary Ann

    2009-01-01

    Using curriculum-specific tools for measuring fidelity of implementation is an essential yet often overlooked aspect of examining relationships among textbooks, teaching, and student learning. This "Brief Report" describes the variety of ways that curriculum implementation is measured and argues that there is an urgent need to develop…

  2. Social media in clinical trials.

    Science.gov (United States)

    Thompson, Michael A

    2014-01-01

    Social media has potential in clinical trials for pointing out trial issues, addressing barriers, educating, and engaging multiple groups involved in cancer clinical research. Social media is being used in clinical trials to highlight issues such as poor accrual and barriers; educate potential participants and physicians about clinical trial options; and is a potential indirect or direct method to improve accrual. We are moving from a passive "push" of information to patients to a "pull" of patients requesting information. Patients and advocates are often driving an otherwise reluctant health care system into communication. Online patient communities are creating new information repositories. Potential clinical trial participants are using the Twittersphere and other sources to learn about potential clinical trial options. We are seeing more organized patient-centric and patient-engaged forums with the potential to crowd source to improve clinical trial accrual and design. This is an evolving process that will meet many individual, institutional, and regulatory obstacles as we move forward in a changed research landscape. PMID:24857086

  3. The Dynamo Clinical Trial

    Science.gov (United States)

    Ayres, Thomas R.

    2016-04-01

    The Dynamo Clinical Trial evaluates long-term stellar magnetic health through periodic X-ray examinations (by the Chandra Observatory). So far, there are only three subjects enrolled in the DTC: Alpha Centauri A (a solar-like G dwarf), Alpha Cen B (an early K dwarf, more active than the Sun), and Alpha Canis Majoris A (Procyon, a mid-F subgiant similar in activity to the Sun). Of these, Procyon is a new candidate, so it is too early to judge how it will fare. Of the other two, Alpha Cen B has responded well, with a steady magnetic heartbeat of about 8 years duration. The sickest of the bunch, Alpha Cen A, was in magnetic cardiac arrest during 2005-2010, but has begun responding to treatment in recent years, and seems to be successfully cycling again, perhaps achieving a new peak of magnetic health in the 2016 time frame. If this is the case, it has been 20 years since A's last healthful peak, significantly longer than the middle-aged Sun's 11-year magnetic heartbeat, but perhaps in line with Alpha Cen A's more senescent state (in terms of "relative evolutionary age," apparently an important driver of activity). (By the way, don't miss the exciting movie of the Alpha Cen stars' 20-year X-ray dance.)

  4. Central Institutional Review Board Review for an Academic Trial Network

    Science.gov (United States)

    Kaufmann, Petra; O’Rourke, P. Pearl

    2016-01-01

    Problem Translating discoveries into therapeutics is often delayed by lengthy start-up periods for multicenter clinical trials. One cause of delay can be multiple institutional review board (IRB) reviews of the same protocol. Approach When developing the Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT; hereafter, NN), the National Institute of Neurological Disorders and Stroke (NINDS) established a central IRB (CIRB) based at Massachusetts General Hospital, the academic medical center that received the NN clinical coordinating center grant. The 25 NN sites, located at U.S. academic institutions, agreed to required CIRB use for NN trials. Outcomes To delineate roles and establish legal relationships between the NN sites and the CIRB, the CIRB executed reliance agreements with the sites and their affiliates that hold federalwide assurance for the protection of human subjects (FWA); this took, on average, 84 days. The first NN protocol reviewed by the CIRB achieved full approval to allow participant enrollment within 56 days and went from grant award to the first patient visit in less than four months. The authors describe anticipated challenges related to institutional oversight responsibilities versus regulatory CIRB review as well as unanticipated challenges related to working with complex organizations that include multiple FWA-holding affiliates. Next Steps The authors anticipate that CIRB use will decrease NN trial start-up time and thus promote efficient trial implementation. They plan to collect data on timelines and costs associated with CIRB use. The NINDS plans to promote CIRB use in future initiatives. PMID:25406606

  5. From concept to content: assessing the implementation fidelity of a chronic care model for frail, older people who live at home.

    NARCIS (Netherlands)

    Muntinga, M.E.; Leeuwen, K.M. van; Schellevis, F.G.; Nijpels, G.; Jansen, A.P.D.

    2015-01-01

    Background: Implementation fidelity, the degree to which a care program is implemented as intended, can influence program impact. Since results of trials that aim to implement comprehensive care programs for frail, older people have been conflicting, assessing implementation fidelity alongside these

  6. Prevention trial in the Cherokee Nation: design of a randomized community trial.

    Science.gov (United States)

    Komro, Kelli A; Wagenaar, Alexander C; Boyd, Misty; Boyd, B J; Kominsky, Terrence; Pettigrew, Dallas; Tobler, Amy L; Lynne-Landsman, Sarah D; Livingston, Melvin D; Livingston, Bethany; Molina, Mildred M Maldonado

    2015-02-01

    Despite advances in prevention science and practice in recent decades, the U.S. continues to struggle with significant alcohol-related risks and consequences among youth, especially among vulnerable rural and Native American youth. The Prevention Trial in the Cherokee Nation is a partnership between prevention scientists and Cherokee Nation Behavioral Health to create, implement, and evaluate a new, integrated community-level intervention designed to prevent underage drinking and associated negative consequences among Native American and other youth living in rural high-risk underserved communities. The intervention builds directly on results of multiple previous trials of two conceptually distinct approaches. The first is an updated version of CMCA, an established community environmental change intervention, and the second is CONNECT, our newly developed population-wide intervention based on screening, brief intervention, and referral to treatment (SBIRT) research. CMCA direct-action community organizing is used to engage local citizens to address community norms and practices related to alcohol use and commercial and social access to alcohol among adolescents. The new CONNECT intervention expands traditional SBIRT to be implemented universally within schools. Six key research design elements optimize causal inference and experimental evaluation of intervention effects, including a controlled interrupted time-series design, purposive selection of towns, random assignment to study condition, nested cohorts as well as repeated cross-sectional observations, a factorial design crossing two conceptually distinct interventions, and multiple comparison groups. The purpose of this paper is to describe the strong partnership between prevention scientists and behavioral health leaders within the Cherokee Nation, and the intervention and research design of this new community trial. PMID:24615546

  7. Student Participation in Rover Field Trials

    Science.gov (United States)

    Bowman, C. D.; Arvidson, R. E.; Nelson, S. V.; Sherman, D. M.; Squyres, S. W.

    2001-12-01

    The LAPIS program was developed in 1999 as part of the Athena Science Payload education and public outreach, funded by the JPL Mars Program Office. For the past three years, the Athena Science Team has been preparing for 2003 Mars Exploration Rover Mission operations using the JPL prototype Field Integrated Design and Operations (FIDO) rover in extended rover field trials. Students and teachers participating in LAPIS work with them each year to develop a complementary mission plan and implement an actual portion of the annual tests using FIDO and its instruments. LAPIS is designed to mirror an end-to-end mission: Small, geographically distributed groups of students form an integrated mission team, working together with Athena Science Team members and FIDO engineers to plan, implement, and archive a two-day test mission, controlling FIDO remotely over the Internet using the Web Interface for Telescience (WITS) and communicating with each other by email, the web, and teleconferences. The overarching goal of LAPIS is to get students excited about science and related fields. The program provides students with the opportunity to apply knowledge learned in school, such as geometry and geology, to a "real world" situation and to explore careers in science and engineering through continuous one-on-one interactions with teachers, Athena Science Team mentors, and FIDO engineers. A secondary goal is to help students develop improved communication skills and appreciation of teamwork, enhanced problem-solving skills, and increased self-confidence. The LAPIS program will provide a model for outreach associated with future FIDO field trials and the 2003 Mars mission operations. The base of participation will be broadened beyond the original four sites by taking advantage of the wide geographic distribution of Athena team member locations. This will provide greater numbers of students with the opportunity to actively engage in rover testing and to explore the possibilities of

  8. Implementing Cognitive Behavioral Therapy for Chronic Fatigue Syndrome in a Mental Health Center: A Benchmarking Evaluation

    Science.gov (United States)

    Scheeres, Korine; Wensing, Michel; Knoop, Hans; Bleijenberg, Gijs

    2008-01-01

    Objective: This study evaluated the success of implementing cognitive behavioral therapy (CBT) for chronic fatigue syndrome (CFS) in a representative clinical practice setting and compared the patient outcomes with those of previously published randomized controlled trials (RCTs) of CBT for CFS. Method: The implementation interventions were the…

  9. Co-design and implementation research: challenges and solutions for ethics committees

    OpenAIRE

    Goodyear-Smith, F; Jackson, C; Greenhalgh, T.

    2015-01-01

    Background Implementation science research, especially when using participatory and co-design approaches, raises unique challenges for research ethics committees. Such challenges may be poorly addressed by approval and governance mechanisms that were developed for more traditional research approaches such as randomised controlled trials. Discussion Implementation science commonly involves the partnership of researchers and stakeholders, attempting to understand and encourage uptake of complet...

  10. National Lung Screening Trial (NLST)

    Science.gov (United States)

    The National Lung Screening Trial (NLST), a research study sponsored by the National Cancer Institute that used low-dose helical CT scans or chest X-ray to screen men and women at risk for lung cancer.

  11. The ALCHEMIST Lung Cancer Trial

    Science.gov (United States)

    A collection of material about the ALCHEMIST lung cancer trial that will examine tumor tissue from patients with early-stage, completely resected lung cancer for gene mutations in the EGFR and ALK genes, and a

  12. Types of Treatment: Clinical Trials

    Science.gov (United States)

    ... Previous Article Palliative Care Next Article How a Clinical Trial Works Follow us Subscribe to a newsletter This field is required ... Fundraising Disclosure Refund Policy Work for LLS Contact Us Email Subscription Center

  13. Register or electronic health records enriched randomized pragmatic trials: The future of clinical effectiveness and cost-effectiveness trials?

    Directory of Open Access Journals (Sweden)

    Joakim Ramsberg

    2015-03-01

    Full Text Available For many interventions in health care, there is limited information on efficacy, safety and cost-effectiveness even long after they have been implemented. To decide between treatments, the randomized controlled trial (RCT provides the strongest evidence. This creates a problem because RCTs are very expensive, logistically challenging and generally cumbersome. Observational studies are inexpensive, but create weaker evidence. The pragmatic randomized trial, enriched with routinely collected register or electronic health record  (EHR data may be a solution to this dilemma since they are much less costly than traditional RCTs but create much stronger evidence than observational studies. Pragmatic randomized trials mean that patients in routine care are randomly allocated to alternative treatments. The outcome of the treatment is then followed up in existing registers with patient data. This means that it is possible to 1 follow patients in the normal care situation - unlike the often artificial situation in the traditional RCT, 2 that the costs are low, even for large studies and 3 that a broad spectrum of outcomes, including both health and economic outcomes, can be collected. Pragmatic randomized trials using register or EHR data in principle lend themselves well to health economic evaluations. We have identified a number of such trials in the literature. Very few, however, include economic outcomes.

  14. Implementing function spreadsheets

    DEFF Research Database (Denmark)

    Sestoft, Peter

    : that of turning an expression into a named function. Hence they proposed a way to define a function in terms of a worksheet with designated input and output cells; we shall call it a function sheet. The goal of our work is to develop implementations of function sheets and study their application to...... realistic examples. Therefore, we are also developing a simple yet comprehensive spreadsheet core implementation for experimentation with this technology. Here we report briefly on our experiments with function sheets as well as other uses of our spreadsheet core implementation....

  15. INTEGER FACTORIZATION IMPLEMENTATIONS

    Directory of Open Access Journals (Sweden)

    Reza Alimoradi

    2016-06-01

    Full Text Available One difficult problem of mathematics that forms the basics of some public key cryptography systems like RSA, is finding factors of big numbers. To solve this problem, many factorization algorithms have been offered with different complexities. Many attempts have been made today to implement these factorization algorithms. And these implementations are different from various aspects. Each of these factorization algorithms is efficient for numbers with a specific size. These algorithms can be compared with regard to time and memory complexity. In this paper, some of these implementations are studied and compared and consequently the most appropriate one will be introduced.

  16. Global warming on trial

    International Nuclear Information System (INIS)

    Jim Hansen, a climatologist at NASA's Goddard Space Institute, is convinced that the earth's temperature is rising and places the blame on the buildup of greenhouse gases in the atmosphere. Unconvinced, John Sununu, former White House chief of staff, doubts that the warming will be great enough to produce serious threat and fears that measures to reduce the emissions would throw a wrench into the gears that drive the Unites States' troubled economy. During his three years at the White House, Sununu's view prevailed, and although his role in the debate has diminished, others continue to cast doubt on the reality of global warming. A new lobbying group called the Climate Council has been created to do just this. Burning fossil fuels is not the only problem; a fifth of emissions of carbon dioxide now come from clearing and burning forests. Scientists are also tracking a host of other greenhouse gases that emanate from a variety of human activities; the warming effect of methane, chlorofluorocarbons and nitrous oxide combined equals that of carbon dioxide. Although the current warming from these gases may be difficult to detect against the background noise of natural climate variation, most climatologists are certain that as the gases continue to accumulate, increases in the earth's temperature will become evident even to skeptics. If the reality of global warming were put on trial, each side would have trouble making its case. Jim Hansen's side could not prove beyond a reasonable doubt that carbon dioxide and other greenhouse gases have warmed the planet. But neither could John Sununu's side prove beyond a reasonable doubt that the warming expected from greenhouse gases has not occurred. To see why each side would have difficulty proving its case, this article reviews the arguments that might be presented in such a hearing

  17. Collaborative trial on groundwater sampling

    OpenAIRE

    Ghestem, Jean Philippe; Fisicaro, Paula; Champion, Rachel

    2011-01-01

    The trial presented here was conducted by BRGM in collaboration with LNE under the work program AQUAREF 2009 with the support of ONEMA. This is a collaborative trial on groundwater sampling and on field physico chemical measurement. It is not a proficiency test. He had three goals: * Observe and evaluate the practices of groundwater sampling to improve future guides, standards and specifications. * Assess the impact of sampling on variability of results. * Study the accuracy of field measurem...

  18. Decision analysis and bioequivalence trials

    OpenAIRE

    Lindley, Dennis V.

    1998-01-01

    It is argued that the determination of bioequivalence involves a decision, and is not purely a problem of inference. A coherent method of decision-making is examined in detail for a simple trial of bioequivalence. The result is shown to differ seriously from the inferential method, using significance tests, ordinarily used. The reason for the difference is explored. It is shown how the decision-analytic method can be used in more complicated and realistic trials and the case...

  19. Malaria Diagnostics in Clinical Trials

    OpenAIRE

    Murphy, Sean C.; Shott, Joseph P.; Parikh, Sunil; Etter, Paige; Prescott, William R.; Stewart, V. Ann

    2013-01-01

    Malaria diagnostics are widely used in epidemiologic studies to investigate natural history of disease and in drug and vaccine clinical trials to exclude participants or evaluate efficacy. The Malaria Laboratory Network (MLN), managed by the Office of HIV/AIDS Network Coordination, is an international working group with mutual interests in malaria disease and diagnosis and in human immunodeficiency virus/acquired immunodeficiency syndrome clinical trials. The MLN considered and studied the wi...

  20. Acupuncture trials and informed consent

    OpenAIRE

    Miller, F. G.; Kaptchuk, T J

    2007-01-01

    Participants are often not informed by investigators who conduct randomised, placebo‐controlled acupuncture trials that they may receive a sham acupuncture intervention. Instead, they are told that one or more forms of acupuncture are being compared in the study. This deceptive disclosure practice lacks a compelling methodological rationale and violates the ethical requirement to obtain informed consent. Participants in placebo‐controlled acupuncture trials should be provided an accurate disc...

  1. DATA WAREHOUSES SECURITY IMPLEMENTATION

    OpenAIRE

    Burtescu Emil

    2009-01-01

    Data warehouses were initially implemented and developed by the big firms and they were used for working out the managerial problems and for making decisions. Later on, because of the economic tendencies and of the technological progress, the data warehou

  2. Hardware Implementation of AES

    Directory of Open Access Journals (Sweden)

    Aakrati Chaturvedi

    2014-01-01

    Full Text Available The Advanced Encryption Standard algorithm can be efficiently programmed in software and implemented in hardware. Field Programmable Gate Array (FPGA devices are considered as efficient and cost effective solution for hardware. This research is in context to efficient hardware implementation of AES algorithm with language platform as VHDL (Very High Speed Integrated Circuit Hardware Description language. This research is in context to efficient hardware implementation of AES algorithm with 128-192-256 key all in one module with language platform as VHDL (Very High Speed Integrated Circuit Hardware Description language. The software part has been created, processed and simulated through Xilinx ISE 9.2. A compact design approach has been chosen to implement the algorithm with minimal hardware. As for hardware, Spartan 3AN family device (XC3S700A device is used

  3. Implementation of Triple RSA

    Directory of Open Access Journals (Sweden)

    Sapna Sejwani*1

    2014-05-01

    Full Text Available The Rivest Shamir Adleman (RSA cryptosystem, named after its creators, is one of the most popular public key cryptosystems. It is most widely used for its strong security feature and easy implementation. The RSA cryptosystem has been utilized for many e-commerce applications, various forms of authentication, and virtual private networks in any organizations. The importance of high security and faster implementations paved the way for hardware implementations of the RSA algorithm. This work consists of describing a new approach to enhance RSA security. In this paper we will enhance the security feature by introducing an advance model called Triple RSA. Although RSA has not been attacked yet, it is still prone to attacks. So to enhance its security we have implemented triple RSA just like triple DES which is extremely secure. This model provides along with confidentiality, a strong authentication, data integrity, tamper detection and non repudiation.

  4. Recovering Policy Implementation

    Directory of Open Access Journals (Sweden)

    Lee S. Duemer

    2002-09-01

    Full Text Available This study identifies themes in the theoretical literature on policy implementation that can then be used to develop a research-based framework for the scholar about how qualitative research can be used to analyze policy implementation through the investigation of informal and formal communication lines. This article draws from existing scholarship to bridge the gap between policy studies and qualitative research to explore innovative ways for scholars to expand our understanding of policy implementation. The article uses the literature to propose a framework that can be used to examine policy implementation. The framework is based on the concepts of Orientation, Degree, Resources, Activity, Autonomy, Societal Values, Institutional Values, Rationale and Power Relationship.

  5. Digital film library implementation

    Science.gov (United States)

    Kishore, Sheel; Khalsa, Satjeet S.; Seshadri, Sridhar B.; Arenson, Ronald L.

    1991-07-01

    The Radiology Department at the University of Pennsylvania is in the process of clinically testing its PACS implementation. The PACS implementation has been built around a Vortech Image Archival and Retrieval System (IARS) with a 140-platter optical jukebox. The Vortech IARS provides archival services only. A set of software modules have been developed in-house that allow the system to function as a digital film library. The current implementation allows connectivity to a RIS (DECrad), supports the routing of images to two intensive care units, and allows image acquisition from a Du Pont FD2000 laser scanner and two GE SIGNA MR units. All process-to-process communication follows the ACR/NEMA 2.0 protocol. The proposed folder extensions to ACR/NEMA 2.0 are being utilized for sending information to the display nodes. The system has been running clinically for about three months. Details of the design, implementation, and functionality of the PACS are presented.

  6. Taking culture seriously in biomedical HIV prevention trials: a meta-synthesis of qualitative studies.

    Science.gov (United States)

    Rubincam, Clara; Lacombe-Duncan, Ashley; Newman, Peter A

    2016-01-01

    A substantial gap exists between widespread acknowledgement of the importance of incorporating cultural sensitivity in biomedical HIV prevention trials and empirical evidence to guide the operationalization of cultural sensitivity in these trials. We conducted a systematic literature search and qualitative meta-synthesis to explore how culture is conceptualized and operationalized in global biomedical HIV prevention trials. Across 29 studies, the majority (n = 17) were conducted in resource-limited settings. We identified four overarching themes: (1) semantic cultural sensitivity - challenges in communicating scientific terminology into local vernaculars; (2) instrumental cultural sensitivity - understanding historical experiences to guide tailoring of trial activities; (3) budgetary, logistical, and personnel implications of operationalizing cultural sensitivity; and (4) culture as an asset. Future investigations should address how sociocultural considerations are operationalized across the spectrum of trial preparedness, implementation, and dissemination in particular sociocultural contexts, including intervention studies and evaluations of the effectiveness of methods used to operationalize culturally sensitive practices. PMID:26560332

  7. Safety culture implementation

    International Nuclear Information System (INIS)

    This document develops the following subjects: analysis of the safety culture concept; function of safety culture in a quality system; reason for the appearance of the safety culture concept; comparison with the condition of conventional industry; practical difficulties that appear for its implementation and evaluation; its importance in radiation medical application; strategies for the implementation of safety culture; how to stimulate the participation and motivation of the personnel; application of the standards to be used

  8. MONA Implementation Secrets

    DEFF Research Database (Denmark)

    Klarlund, Nils; Møller, Anders; Schwartzbach, Michael Ignatieff

    2001-01-01

    The Mona tool provides an implementation of the decision procedures for the logics WS1S and WS2S. It has been used for numerous applications, and it is remarkably efficient in practice, even though it faces a theoretically non-elementary worst-case complexity. The implementation has matured over ...... by experimenting with separate versions of the Mona tool that in turn omit each of them....

  9. Implementation and Mind Control

    OpenAIRE

    Hitoshi Matsushima

    2009-01-01

    This paper incorporates social psychology into implementation theory, where an uninformed principal manipulates a dynamic decision-making process without employing any tailored contractual device. We demonstrate the principal's mind-control method through which he can effectively utilize social psychology tactics to incentivize informed agents to announce their information in keeping with his wishes. We show that with incentive compatibility, the principal can implement any alternative that h...

  10. Secret Key Crypto Implementations

    Science.gov (United States)

    Bertoni, Guido Marco; Melzani, Filippo

    This chapter presents the algorithm selected in 2001 as the Advanced Encryption Standard. This algorithm is the base for implementing security and privacy based on symmetric key solutions in almost all new applications. Secret key algorithms are used in combination with modes of operation to provide different security properties. The most used modes of operation are presented in this chapter. Finally an overview of the different techniques of software and hardware implementations is given.

  11. Implementing situational awareness

    OpenAIRE

    Hulkkonen, Timo

    2016-01-01

    Implementation of situational awareness system became an objective when Finnish national regulations for A-class systems, in the context of healthcare systems were updated. The updated criteria require IT service providers to have a capability to detect anomalies in information systems. Situational awareness was selected to meet those criteria because situational awareness can be used as a tool which helps the organization to improve its service. The objective was to implement a cost effe...

  12. Common statistical concerns in clinical trials

    OpenAIRE

    Evans, Scott R.

    2010-01-01

    Statistics are an integral part of clinical trials. Elements of statistics span clinical trial design, data monitoring, analyses, and reporting. A solid understanding of statistical concepts by clinicians improves the comprehension and the resulting quality of clinical trials. This manuscript outlines common statistical concerns in clinical trials that are important for clinicians to understand.

  13. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram;

    2010-01-01

    Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly...... variable. Generation of trial databases and/or biobanks originating in large randomized clinical trials has successfully increased the knowledge obtained from those trials. At the 10th Cardiovascular Trialist Workshop, possibilities and pitfalls in designing and accessing clinical trial databases were...

  14. The DIAMOND initiative: implementing collaborative care for depression in 75 primary care clinics

    OpenAIRE

    Solberg, Leif I.; Crain, A. Lauren; Jaeckels, Nancy; Ohnsorg, Kris A.; Margolis, Karen L; Beck, Arne; Whitebird, Robin R.; Rossom, Rebecca C.; Crabtree, Benjamin F.; Andrew H. Van de Ven

    2013-01-01

    Background The many randomized trials of the collaborative care model for improving depression in primary care have not described the implementation and maintenance of this model. This paper reports how and the degree to which collaborative care process changes were implemented and maintained for the 75 primary care clinics participating in the DIAMOND Initiative (Depression Improvement Across Minnesota–Offering a New Direction). Methods Each clinic was trained to implement seven components o...

  15. Interventional trials in atypical parkinsonism.

    Science.gov (United States)

    Eschlböck, S; Krismer, F; Wenning, G K

    2016-01-01

    Atypical parkinson disorders (APD) are rapidly progressive neurodegenerative diseases with a variable clinical presentation that may even mimic Parkinson's disease. Multiple system atrophy (MSA), progressive supranuclear palsy (PSP) and corticobasal degeneration (CBD) are commonly summarized under this umbrella term. Significant developments in research have expanded knowledge and have broadened available symptomatic treatments, particularly for the treatment of neurogenic orthostatic hypotension. Nonetheless, symptomatic support still remains limited in all of these disorders. Currently, there exists no effective treatment to delay disease progression and disease-modifying trials have failed to provide coherent and convincing results. Recent trials of rasagiline (in MSA), rifampicin (in MSA), tideglusib (in PSP) and davunetide (in PSP) reported negative results. Nevertheless, large cohorts of patients were recruited for interventional studies in the last few years which improved our understanding of trial methodology in APDs immensely. In addition, remarkable progress in basic research has been reported recently and will provide a solid foundation for future therapeutic trials. In this review, we will summarize published randomized, placebo-controlled clinical trials (RCTs) in APDs. Additionally, the design of ongoing and unpublished interventions will be presented. PMID:26421389

  16. Program Implementation Plan

    International Nuclear Information System (INIS)

    The Program Implementation Plan (PIP) describes the US Department of Energy's (DOE's) current approaches for managing the permanent disposal of defense high-level waste (HLW), transuranic (TRU) waste, and low-level waste (LLW) from atomic energy defense activities. It documents the implementation of the HLW and TRU waste policies as stated in the Defense Waste Management Plan (DWMP) (DOE/DP-0015), dated June 1983, and also addresses the management of LLW. The narrative reflects both accomplishments and changes in the scope of activities. All cost tables and milestone schedules are current as of January 1987. The goals of the program, to provide safe processing and utilization, storage, and disposal of DOE radioactive waste and byproducts to support defense nuclear materials production activities, and to implement cost-effective improvements in all of its ongoing and planned activities, have not changed

  17. Alzheimer’s disease multiple intervention trial (ADMIT: study protocol for a randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Callahan Christopher M

    2012-06-01

    Full Text Available Abstract Background Given the current lack of disease-modifying therapies, it is important to explore new models of longitudinal care for older adults with dementia that focus on improving quality of life and delaying functional decline. In a previous clinical trial, we demonstrated that collaborative care for Alzheimer’s disease reduces patients’ neuropsychiatric symptoms as well as caregiver stress. However, these improvements in quality of life were not associated with delays in subjects’ functional decline. Trial design Parallel randomized controlled clinical trial with 1:1 allocation. Participants A total of 180 community-dwelling patients aged ≥45 years who are diagnosed with possible or probable Alzheimer’s disease; subjects must also have a caregiver willing to participate in the study and be willing to accept home visits. Subjects and their caregivers are enrolled from the primary care and geriatric medicine practices of an urban public health system serving Indianapolis, Indiana, USA. Interventions All patients receive best practices primary care including collaborative care by a dementia care manager over two years; this best practices primary care program represents the local adaptation and implementation of our prior collaborative care intervention in the urban public health system. Intervention patients also receive in-home occupational therapy delivered in twenty-four sessions over two years in addition to best practices primary care. The focus of the occupational therapy intervention is delaying functional decline and helping both subjects and caregivers adapt to functional impairments. The in-home sessions are tailored to the specific needs and goals of each patient-caregiver dyad; these needs are expected to change over the course of the study. Objective To determine whether best practices primary care plus home-based occupational therapy delays functional decline among patients with Alzheimer’s disease compared

  18. Implementing the legislation

    International Nuclear Information System (INIS)

    Leon Silverstrom explained how nuclear waste disposal legislation would be implemented. The legislation provides a framework that recognizes the tremendous number of views and opinions on the subject and provides a mechanism that will allow all these interests to be expressed before final decisions are reached. Implementing procedures are outlined for: (1) the final repository; (2) interim or last resort storage; (3) research and development; (4) the monitored retrievable storage phases. The whole process will involve: environmental assessments and licensing requirements for each phase; construction of a test and evaluation facility; provision for sharing information with the states and interested parties; and procedures for public hearings and state rejection of propoped sites

  19. Implementing Samba 4

    CERN Document Server

    Leal, Marcelo

    2014-01-01

    This book is an implementation tutorial covering step-by-step procedures, examples, and sample code, and has a practical approach to set up a Samba 4 Server as an Active Directory Domain Controller and also set up different Samba 4 server roles.This book is ideal for system administrators who are new to the Samba 4 software, and who are looking to get a good grounding in how to use Samba 4 to implement Active Directory Services. It's assumed that you will have some experience with general system administration, Active Directory, and GNU/Linux systems. Readers are expected to have some test mac

  20. Environmental protection implementation plan

    International Nuclear Information System (INIS)

    This Environmental Protection Implementation Plan is intended to ensure that the environmental program objectives of Department of Energy Order 5400.1 are achieved at SNL/California. This document states SNL/California's commitment to conduct its operations in an environmentally safe and responsible manner. The Environmental Protection Implementation Plan helps management and staff comply with applicable environmental responsibilities. SNL is committed to operating in full compliance with the letter and spirit of applicable environmental laws, regulations, and standards. Furthermore, SNL/California strives to go beyond compliance with legal requirements by making every effort practical to reduce impacts to the environment to levels as low as reasonably achievable

  1. Obtaining valid laboratory data in clinical trials conducted in resource diverse settings: lessons learned from a microbicide phase III clinical trial.

    Directory of Open Access Journals (Sweden)

    Tania Crucitti

    Full Text Available BACKGROUND: Over the last decade several phase III microbicides trials have been conducted in developing countries. However, laboratories in resource constrained settings do not always have the experience, infrastructure, and the capacity to deliver laboratory data meeting the high standards of clinical trials. This paper describes the design and outcomes of a laboratory quality assurance program which was implemented during a phase III clinical trial evaluating the efficacy of the candidate microbicide Cellulose Sulfate 6% (CS [1]. METHODOLOGY: In order to assess the effectiveness of CS for HIV and STI prevention, a phase III clinical trial was conducted in 5 sites: 3 in Africa and 2 in India. The trial sponsor identified an International Central Reference Laboratory (ICRL, responsible for the design and management of a quality assurance program, which would guarantee the reliability of laboratory data. The ICRL provided advice on the tests, assessed local laboratories, organized trainings, conducted supervision visits, performed re-tests, and prepared control panels. Local laboratories were provided with control panels for HIV rapid tests and Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG amplification technique. Aliquots from respective control panels were tested by local laboratories and were compared with results obtained at the ICRL. RESULTS: Overall, good results were observed. However, discordances between the ICRL and site laboratories were identified for HIV and CT/NG results. One particular site experienced difficulties with HIV rapid testing shortly after study initiation. At all sites, DNA contamination was identified as a cause of invalid CT/NG results. Both problems were timely detected and solved. Through immediate feedback, guidance and repeated training of laboratory staff, additional inaccuracies were prevented. CONCLUSIONS: Quality control guidelines when applied in field laboratories ensured the reliability and validity

  2. Ethical issues in implementation research: a discussion of the problems in achieving informed consent

    Directory of Open Access Journals (Sweden)

    Eccles Martin P

    2008-12-01

    Full Text Available Abstract Background Improved quality of care is a policy objective of health care systems around the world. Implementation research is the scientific study of methods to promote the systematic uptake of clinical research findings into routine clinical practice, and hence to reduce inappropriate care. It includes the study of influences on healthcare professionals' behaviour and methods to enable them to use research findings more effectively. Cluster randomized trials represent the optimal design for evaluating the effectiveness of implementation strategies. Various codes of medical ethics, such as the Nuremberg Code and the Declaration of Helsinki inform medical research, but their relevance to cluster randomised trials in implementation research is unclear. This paper discusses the applicability of various ethical codes to obtaining consent in cluster trials in implementation research. Discussion The appropriate application of biomedical codes to implementation research is not obvious. Discussion of the nature and practice of informed consent in implementation research cluster trials must consider the levels at which consent can be sought, and for what purpose it can be sought. The level at which an intervention is delivered can render the idea of patient level consent meaningless. Careful consideration of the ownership of information, and rights of access to and exploitation of data is required. For health care professionals and organizations, there is a balance between clinical freedom and responsibility to participate in research. Summary While ethical justification for clinical trials relies heavily on individual consent, for implementation research aspects of distributive justice, economics, and political philosophy underlie the debate. Societies may need to trade off decisions on the choice between individualized consent and valid implementation research. We suggest that social sciences codes could usefully inform the consideration of

  3. Benign painful elbow syndrome. First results of a single center prospective randomized radiotherapy dose optimization trial

    Energy Technology Data Exchange (ETDEWEB)

    Ott, O.J.; Hertel, S.; Gaipl, U.S.; Frey, B.; Schmidt, M.; Fietkau, R. [University Hospital Erlangen (Germany). Dept. of Radiation Oncology

    2012-10-15

    Background and purpose: The goal of the present study was to evaluate the efficacy of two different dose-fractionation schedules for radiotherapy (RT) of patients with painful elbow syndrome. Patients and methods: Between February 2006 and February 2010, 199 consecutive evaluable patients were recruited for this prospective randomized trial. All patients received RT in orthovoltage technique. One RT course consisted of 6 single fractions/3 weeks. In case of insufficient remission of pain after 6 weeks a second radiation series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. Endpoint was pain reduction. Pain was measured before, right after, and 6 weeks after RT by a visual analogue scale (VAS) and a comprehensive pain score (CPS). Results: The overall response rate for all patients was 80% direct after and 91% 6 weeks after RT. The mean VAS values before, after and 6 weeks after treatment for the 0.5 and 1.0 Gy groups were 59.6 {+-} 20.2 and 55.7 {+-} 18.0 (p = 0.463), 32.1 {+-} 24.5 and 34.4 {+-} 22.5 (p = 0.256), and 27.0 {+-} 27.7 and 23.5 {+-} 21.6 (p = 0.818). The mean CPS before, after, and 6 weeks after treatment was 8.7 {+-} 2.9 and 8.1 {+-} 3.1 (p = 0.207), 4.5 {+-} 3.2 and 5.0 {+-} 3.4 (p = 0.507), 3.9 {+-} 3.6 and 2.8 {+-} 2.8 (p = 0.186), respectively. No statistically significant differences between the two single dose trial arms for early (p = 0.103) and delayed response (p = 0.246) were found. Conclusion: RT is an effective treatment option for the management of benign painful elbow syndrome. For radiation protection reasons the dose for a RT series is recommended not to exceed 3.0 Gy. (orig.)

  4. Beyond Binary: Using Propensity Scores to Account for Varying Levels of Program Participation in Randomized Controlled Trials

    Science.gov (United States)

    Stuart, Elizabeth A.; Warkentien, Siri; Jo, Booil

    2011-01-01

    The purpose of the current project is to explore the use of propensity scores to estimate the effects of interventions within randomized control trials, accounting for varying levels of implementation or fidelity. This work extends that of Jo and Stuart (2009) to settings with multiple or continuous measures of implementation. Rather than focus…

  5. Crew resource management training in the intensive care unit: a multisite controlled before-after study.

    NARCIS (Netherlands)

    Kemper, P.F.; Bruijne, M. de; Dyck, C. van; So, R.L.; Tangkau, P.; Wagner, C.

    2016-01-01

    Introduction There is a growing awareness today that adverse events in the intensive care unit (ICU) are more often caused by problems related to non-technical skills than by a lack of technical, or clinical, expertise. Team training, such as crew resource management (CRM), aims to improve these non

  6. Viscous behavior of aqueous HEC in moderate concentration domain before after gamma irradiation

    International Nuclear Information System (INIS)

    Radiative degradation curve of hydroxyethyl cellulose ((HEC) in aqueous solution has been reported. Densities and solution viscosities of aqueous HEC in moderate concentration domain before and after irradiation have been measured. Gamma irradiation HEC decreases the values of density, specific, reduced and intrinsic viscosities, molar mass and hydrodynamic volume of HEC in solution. However, it increases the value of Schulz-Backlash constant, solute-solvent interaction and decreases the solute- solute contact in the solution of degradable HEC

  7. Before-after field study of effects of wind turbine noise on polysomnographic sleep parameters.

    Science.gov (United States)

    Jalali, Leila; Bigelow, Philip; Nezhad-Ahmadi, Mohammad-Reza; Gohari, Mahmood; Williams, Diane; McColl, Steve

    2016-01-01

    Wind is considered one of the most advantageous alternatives to fossil energy because of its low operating cost and extensive availability. However, alleged health-related effects of exposure to wind turbine (WT) noise have attracted much public attention and various symptoms, such as sleep disturbance, have been reported by residents living close to wind developments. Prospective cohort study with synchronous measurement of noise and sleep physiologic signals was conducted to explore the possibility of sleep disturbance in people hosting new industrial WTs in Ontario, Canada, using a pre and post-exposure design. Objective and subjective sleep data were collected through polysomnography (PSG), the gold standard diagnostic test, and sleep diary. Sixteen participants were studied before and after WT installation during two consecutive nights in their own bedrooms. Both audible and infrasound noises were also concurrently measured inside the bedroom of each participant. Different noise exposure parameters were calculated (LAeq, LZeq) and analyzed in relation to whole-night sleep parameters. Results obtained from PSG show that sleep parameters were not significantly changed after exposure. However, reported sleep qualities were significantly (P = 0.008) worsened after exposure. Average noise levels during the exposure period were low to moderate and the mean of inside noise levels did not significantly change after exposure. The result of this study based on advanced sleep recording methodology together with extensive noise measurements in an ecologically valid setting cautiously suggests that there are no major changes in the sleep of participants who host new industrial WTs in their community. Further studies with a larger sample size and including comprehensive single-event analyses are warranted. PMID:27569407

  8. Before & after the economic crisis 2008: Changes in Pay Structure of Top UK Bank Executives

    OpenAIRE

    Kumar, Subrat

    2011-01-01

    The main idea of my dissertation is to determine the effect of firm’s performance on the remuneration package during the financial crisis 2008. The form & pay structure of top executives of UK banks has been subjected to major changes within the financial crisis. There has been a complexity in executive pay because of the number of different pay components were associated with the pay structure. My study will explore different remuneration components such as Executive Share Options: The lo...

  9. Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study

    OpenAIRE

    Prayle, A.P.; Hurley, M.N.; Smyth, Alan R

    2012-01-01

    Objective To examine compliance with mandatory reporting of summary clinical trial results (within one year of completion of trial) on ClinicalTrials.gov for studies that fall under the recent Food and Drug Administration Amendments Act (FDAAA) legislation. Design Registry based study of clinical trial summaries. Data sources ClinicalTrials.gov, searched on 19 January 2011, with cross referencing with Drugs@FDA to determine for which trials mandatory reporting was required within one...

  10. MIRANDA RULE. IMPACT ON THE ROMANIAN CRIMINAL TRIAL

    Directory of Open Access Journals (Sweden)

    Mircea DAMASCHIN

    2009-10-01

    Full Text Available We hereby want to analyze the right of the accused or of the defendant against self incrimination in a criminal trial, a relatively recent right introduced in the Romanian law, directly connected with the right to self defense in a criminal trial. Furthermore, we will approach the obligations held by the Romanian legislator, within the prerogatives of the criminal legal authorities for guaranteeing this right and meanings that can be retained in case of breach of such procedure. In order to establish the origin of the regulation, the first section of the study will describe the history of the institution, starting from the Supreme Court jurisprudence from the state if Arizona in the already famous trial Arizona vs. Miranda. We will further present the legal framework instituted for implementing this right in the European legal space, section in which we will also approach the position of the European Court of Human Rights with respect to the issue subjected to the analysis. In the third section, we will present the legal framework instituted in Romania, while attempting to mainly highlight the legal relevance of this basic procedural right, as well as the possibility of retaining the existence of an inter conditioning with the principle of the right to a fair trial, according to the European Convention on Human Rights and Fundamental Freedoms.

  11. Adiabatically implementing quantum gates

    International Nuclear Information System (INIS)

    We show that, through the approach of quantum adiabatic evolution, all of the usual quantum gates can be implemented efficiently, yielding running time of order O(1). This may be considered as a useful alternative to the standard quantum computing approach, which involves quantum gates transforming quantum states during the computing process

  12. EPBD implementation in Denmark

    DEFF Research Database (Denmark)

    Wittchen, Kim Bjarne; Thomsen, Kirsten Engelund; Malmsteen, Margit; Mehlsen, Emilie Svensdatter

    This report presents an overview of the current status of the implementation of the Directive on the Energy Performance of Buildings (EPBD) in Denmark, as well as plans for its evolution. It addresses the energy requirements, as well as the certification and inspection systems, including quality ...

  13. Implementing environmental commitments

    Energy Technology Data Exchange (ETDEWEB)

    Victor, D.G.; Skolnikoff, E.B. [IIASA, Laxenburg (Austria)

    1997-08-01

    The article summarises the aims and results of a three-year project conducted at the International Institute for Applied Systems Analysis called `Implementation and effectiveness of international environmental commitments` (IEC) which analysed how many environmental commitments are implemented or how intentions are put into practice. Fourteen case studies were conducted on the following issues: conservation and preservation of fauna and flora; stratospheric ozone depletion; Baltic sea pollution; trade in hazardous chemicals and pesticides; acid rain in Europe; North Sea pollution; whaling; and marine dumping of nuclear waste. The research confirmed previous findings that compliance with legally binding commitments is high. However, IEC results suggest that high compliance reflects mainly that governments make special effort to adopt only those commitments with which they can comply. The influence of those commitments is often low. In contrast, compliance with nonbinding commitments has been low, but such commitments can often have a large influence on behavior. The findings differs sharply from conventional wisdom, which maintains that the most effective international commitments are legally binding. The research suggests more attention is needed to building systems for gathering and reviewing data on implementation and for handling implementation problems. Among IEC`s contributions to policy has been to apply this finding to the design of possible non-compliance procedures within the United Nations Framework Convention on Climate Change.

  14. Protocol Implementation Generator

    DEFF Research Database (Denmark)

    Carvalho Quaresma, Jose Nuno; Probst, Christian W.

    2010-01-01

    Users expect communication systems to guarantee, amongst others, privacy and integrity of their data. These can be ensured by using well-established protocols; the best protocol, however, is useless if not all parties involved in a communication have a correct implementation of the protocol and a...

  15. Implementing Rooftop Solar Projects

    OpenAIRE

    Sinha, Pankaj; Sethi, Shaina

    2015-01-01

    This brief showcases the challenges of structuring and developing rooftop solar photovoltaic projects using the public-private partnership model. The case study focuses on the experience of the International Finance Corporation in assisting the government of Gujarat, India, in developing the rooftop solar PV model through the implementation of two citywide, grid-connected rooftop solar PV ...

  16. DATA WAREHOUSES SECURITY IMPLEMENTATION

    Directory of Open Access Journals (Sweden)

    Burtescu Emil

    2009-05-01

    Full Text Available Data warehouses were initially implemented and developed by the big firms and they were used for working out the managerial problems and for making decisions. Later on, because of the economic tendencies and of the technological progress, the data warehou

  17. Design and Implementation of an Extensible Learner-Adaptive Environment

    Directory of Open Access Journals (Sweden)

    Kiyoshi Nakabayashi

    2010-09-01

    Full Text Available This paper describes the design and implementation of a flexible architecture that is capable of extending the functions of a learner-adaptive self-learning environment. A “courseware object”, which is a program module that is used to implement various educational functionalities, has been newly introduced to ensure both function extensibility as well as content reusability. A prototype system was designed and implemented to investigate the feasibility of the proposed architecture and to identify the core behavior and interaction schema of courseware objects. The results from this trial indicated that several learner-adaptive functionalities including the SCORM 2004 standard specifications will be able to be successfully implemented into the proposed architecture.

  18. Risk Management Implementation Tool

    Science.gov (United States)

    Wright, Shayla L.

    2004-01-01

    Continuous Risk Management (CM) is a software engineering practice with processes, methods, and tools for managing risk in a project. It provides a controlled environment for practical decision making, in order to assess continually what could go wrong, determine which risk are important to deal with, implement strategies to deal with those risk and assure the measure effectiveness of the implemented strategies. Continuous Risk Management provides many training workshops and courses to teach the staff how to implement risk management to their various experiments and projects. The steps of the CRM process are identification, analysis, planning, tracking, and control. These steps and the various methods and tools that go along with them, identification, and dealing with risk is clear-cut. The office that I worked in was the Risk Management Office (RMO). The RMO at NASA works hard to uphold NASA s mission of exploration and advancement of scientific knowledge and technology by defining and reducing program risk. The RMO is one of the divisions that fall under the Safety and Assurance Directorate (SAAD). I worked under Cynthia Calhoun, Flight Software Systems Engineer. My task was to develop a help screen for the Continuous Risk Management Implementation Tool (RMIT). The Risk Management Implementation Tool will be used by many NASA managers to identify, analyze, track, control, and communicate risks in their programs and projects. The RMIT will provide a means for NASA to continuously assess risks. The goals and purposes for this tool is to provide a simple means to manage risks, be used by program and project managers throughout NASA for managing risk, and to take an aggressive approach to advertise and advocate the use of RMIT at each NASA center.

  19. Combining dosimetry and toxicity: analysis of two UK phase III clinical trials

    International Nuclear Information System (INIS)

    There are many advantages to performing a clinical trial when implementing a novel radiotherapy technique. The clinical trials framework enables the safety and efficacy of the 'experimental arm' to be tested and ensures practical support, rigorous quality control and data monitoring for participating centres. In addition to the clinical and follow-up data collected from patients within the trial, it is also possible to collect 3-D dosimetric information from the corresponding radiotherapy treatment plans. Analysing the combination of dosimetric, clinical and follow-up data enhances the understanding of the relationship between the dose delivered to both the target and normal tissue structures and reported outcomes and toxicity. Aspects of the collection, collation and analysis of data from two UK multicentre Phase III radiotherapy trials are presented here. MRC-RT01 dose-escalation prostate radiotherapy trial ISRCTN47772397 was one of the first UK multi-centre radiotherapy trials to collect 3-D dosimetric data. A number of different analysis methodologies were implemented to investigate the relationship between the dose distribution to the rectum and specific rectal toxicities. More recently data was collected from the PARSPORT trial (Parotid Sparing IMRT vs conventional head and neck radiotherapy) ISRCTN48243537. In addition to the planned analysis, dosimetric analysis was employed to investigate an unexpected finding that acute fatigue was more prevalent in the IMRT arm of the trial. It can be challenging to collect 3-D dosimetric information from multicentre radiotherapy trials. However, analysing the relationship between dosimetric and toxicity data provides invaluable information which can influence the next generation of radiotherapy techniques.

  20. Normalisation process theory: a framework for developing, evaluating and implementing complex interventions

    LENUS (Irish Health Repository)

    Murray, Elizabeth

    2010-10-20

    Abstract Background The past decade has seen considerable interest in the development and evaluation of complex interventions to improve health. Such interventions can only have a significant impact on health and health care if they are shown to be effective when tested, are capable of being widely implemented and can be normalised into routine practice. To date, there is still a problematic gap between research and implementation. The Normalisation Process Theory (NPT) addresses the factors needed for successful implementation and integration of interventions into routine work (normalisation). Discussion In this paper, we suggest that the NPT can act as a sensitising tool, enabling researchers to think through issues of implementation while designing a complex intervention and its evaluation. The need to ensure trial procedures that are feasible and compatible with clinical practice is not limited to trials of complex interventions, and NPT may improve trial design by highlighting potential problems with recruitment or data collection, as well as ensuring the intervention has good implementation potential. Summary The NPT is a new theory which offers trialists a consistent framework that can be used to describe, assess and enhance implementation potential. We encourage trialists to consider using it in their next trial.

  1. The Best Bypass Surgery Trial

    DEFF Research Database (Denmark)

    Møller, Christian H; Jensen, Birte Østergaard; Gluud, Christian; Perko, Mario J; Lund, Jens T; Andersen, Lars Willy; Madsen, Jan Kyst; Hughes, Pia; Steinbrüchel, Daniel A

    2007-01-01

    Recent trials suggest that off-pump coronary artery bypass grafting (OPCAB) reduces the risk of mortality and morbidity compared with conventional coronary artery bypass grafting (CCAB) using cardiopulmonary bypass. Patients with a moderate- to high-risk of complications after CCAB may have addit...

  2. Trials with a Strain Gauge.

    Science.gov (United States)

    Auty, Geoff

    1996-01-01

    Describes an attempt to match the goals of the practical demonstration of the use of a strain gauge and the technical applications of science and responding to student questions in early trials, while keeping within the level of electronics in advanced physics. (Author/JRH)

  3. Ongoing clinical trials in AKI.

    Science.gov (United States)

    Faubel, Sarah; Chawla, Lakhmir S; Chertow, Glenn M; Goldstein, Stuart L; Jaber, Bertrand L; Liu, Kathleen D

    2012-05-01

    AKI is an important public health issue. AKI is a common hospital complication associated with increased in-hospital and long-term mortality, extensive morbidity (including prolonged hospital length of stay), and an estimated annual cost of at least $10 billion in the United States. At present, no specific therapy has been developed to prevent AKI, hasten recovery of kidney function, or abrogate the deleterious systemic effects of AKI. However, recent progress includes establishing a consensus definition of AKI and discovery of novel biomarkers that may allow early detection of AKI. Furthermore, significant insights into the pathophysiology of AKI and its deleterious systemic effects have been gleaned from animal studies. Urgently needed are large, definitive randomized clinical trials testing interventions to prevent and/or treat AKI. This review summarizes and analyzes current ongoing clinical trials registered with clinicaltrials.gov that address prevention or management of AKI. The purpose of this review is to provide a resource for people interested in potential prophylactic and therapeutic approaches to patient care and investigators hoping to plan and execute the next round of randomized clinical trials. Finally, this review discusses research needs that are not addressed by the current clinical trials portfolio and suggests key areas for future research in AKI. PMID:22442183

  4. Implications of the results of community intervention trials.

    Science.gov (United States)

    Sorensen, G; Emmons, K; Hunt, M K; Johnston, D

    1998-01-01

    This paper examines the results of population-level interventions conducted in three settings: entire communities, worksites, and schools. Four major conclusions are discussed: (a) Directions for the next generation of community-based interventions include targeting multiple levels of influence; addressing social inequalities in disease risk; involving communities in program planning and implementation; incorporating approaches for "tailoring" interventions; and utilizing rigorous process evaluation. (b) In addition to randomized controlled trials, it is time to use the full range of research phases available, from hypothesis generation and methods development to dissemination research. (c) The public health research agenda may have contributed to observed secular trends by placing behavioral risk factors on the social and media agendas. (d) The magnitude of the results of community intervention trials must be judged according to their potential public health or population-level effects. Small changes at the individual level may result in large benefits at the population level. PMID:9611625

  5. Using the theory of planned behaviour as a process evaluation tool in randomised trials of knowledge translation strategies: A case study from UK primary care

    OpenAIRE

    Grimshaw Jeremy M; Croal Bernard L; Thomas Ruth E; Ramsay Craig R; Eccles Martin P

    2010-01-01

    Abstract Background Randomised trials of knowledge translation strategies for professional behaviour change can provide robust estimates of effectiveness, but offer little insight into the causal mechanisms by which any change is produced. To illustrate the applicability of causal methods within randomised trials, we undertook a theory-based process evaluation study within an implementation trial to explore whether the cognitions of primary care doctors' predicted their test requesting behavi...

  6. The feasibility of a home-based sedentary behaviour intervention for hospitalised chronic obstructive pulmonary disease (COPD patients: Sitting and ExacerbAtions Trial (COPD-SEAT

    Directory of Open Access Journals (Sweden)

    Mark Orme

    2015-10-01

    COPD-SEAT will be one of the first trials aimed at reducing sedentary behaviour at home in patients hospitalised for an acute exacerbation of COPD. This trial will provide valuable insight into the feasibility of implementing an at-home technology-based feedback intervention for reducing sedentary behaviour into patients existing care. Findings will inform a future large-scale trial acting as an adjuvant to pulmonary rehabilitation.

  7. Safeguards Implementation at KAERI

    International Nuclear Information System (INIS)

    The main objective of the safeguards implementation activities is to assure that there are no diversions of declared nuclear material and/or no undeclared activity. The purpose of safeguards implementation activities is the assistance facility operators to meet the safeguards criteria set forth by the Atomic Energy Safety Acts and Regulations. In addition, the nuclear material and technology control team has acted as a contact point for domestic and international safeguards inspection activities and for the relevant safeguards cooperation. Domestic inspections were successfully carried out at the KAERI nuclear facilities pursuant to the domestic laws and regulations in parallel with the IAEA safeguards inspections. It is expected that safeguards work will be increased due to the pyro-related facilities such as PRIDE, ACPF and DUPIC, for which the IAEA is making an effort to establish safeguards approach. KAERI will actively cope with the plan of the NSSC by changing its domestic inspection regulations on the accounting and control of nuclear materials

  8. Orchestrating Lean Implementation

    DEFF Research Database (Denmark)

    Riis, Jens Ove; Mikkelsen, Hans; Andersen, Jesper Rank

    2008-01-01

    The notion of Lean Manufacturing is not merely confined to a set of well defined techniques, but represents a broad approach to managing a company. Working with lean entails many aspects, such as production planning and control, production engineering, product development, supply chain, and...... organizational issues. To become effective, many functional areas and departments must be involved. At the same time companies are embedded in a dynamic environment. The aim of the paper is to propose a comprehensive approach to better implementation of lean initiatives, based on two empirical studies. The paper...... will discuss how a concerted effort can be staged taking into account the interdependencies among individual improvement initiatives. The notion of orchestration will be introduced, and several means for orchestration will be presented. Critical behavioral issues for lean implementation will be...

  9. IT-implementering

    DEFF Research Database (Denmark)

    Kjeldsen, Lars Peter

    2003-01-01

    Formålet er at beskrive og undersøge hvorledes en it-implementering i en organisation kan støttes af de udvikling- og læringsprincipper, der kan hentes i teorier om den lærende organisation. Empirien bygger på et aktionsforksningsprojekt der havde til hensigt at iagtage og begrebsliggøre kommunik......Formålet er at beskrive og undersøge hvorledes en it-implementering i en organisation kan støttes af de udvikling- og læringsprincipper, der kan hentes i teorier om den lærende organisation. Empirien bygger på et aktionsforksningsprojekt der havde til hensigt at iagtage og begrebsliggøre...

  10. Safeguards Implementation at KAERI

    Energy Technology Data Exchange (ETDEWEB)

    Jung, Juang; Lee, Sung Ho; Lee, Byung-Doo; Kim, Hyun-Sook [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

    2015-05-15

    The main objective of the safeguards implementation activities is to assure that there are no diversions of declared nuclear material and/or no undeclared activity. The purpose of safeguards implementation activities is the assistance facility operators to meet the safeguards criteria set forth by the Atomic Energy Safety Acts and Regulations. In addition, the nuclear material and technology control team has acted as a contact point for domestic and international safeguards inspection activities and for the relevant safeguards cooperation. Domestic inspections were successfully carried out at the KAERI nuclear facilities pursuant to the domestic laws and regulations in parallel with the IAEA safeguards inspections. It is expected that safeguards work will be increased due to the pyro-related facilities such as PRIDE, ACPF and DUPIC, for which the IAEA is making an effort to establish safeguards approach. KAERI will actively cope with the plan of the NSSC by changing its domestic inspection regulations on the accounting and control of nuclear materials.

  11. WEB GIS: IMPLEMENTATION ISSUES

    Institute of Scientific and Technical Information of China (English)

    2000-01-01

    With the rapid expansion and development of Internet and WWW (World Wide Web or Web), Web GIS (Web Geographical Information Systen) is becoming ever more popular and as a result numerous sites have added GIS capability on their Web sites. In this paper, the reasons behind developing a Web GIS instead of a “traditional” GIS are first outlined. Then the current status of Web GIS is reviewed, and their implementation methodologies are explored as well.The underlying technologies for developing Web GIS, such as Web Server, Web browser, CGI (Common Gateway Interface), Java, ActiveX, are discussed, and some typical implementation tools from both commercial and public domain are given as well. Finally, the future development direction of Web GIS is predicted.

  12. Implementing Sustainable Development Strategies

    Institute of Scientific and Technical Information of China (English)

    Zhang Cuiying

    2004-01-01

    China's national sustainable development strategies were drafted under the guidance of Deng Xiaoping's theory on socialist construction with Chinese distinguishing features and, the theory and practice of sustainable development has further enriched and perfected Deng Xiaoping's theory. An in-depth study of Deng Xiaoping's theory is significant if we are to accurately understand our sustainable development program and how to best implement the strategies.

  13. Algorithms and Implementation

    OpenAIRE

    Marques, Rui Filipe Pereira

    2006-01-01

    In the past few years Tabling has emerged as a powerful logic programming model. The integration of concurrent features into the implementation of Tabling systems is demanded by need to use recently developed tabling applications within distributed systems, where a process has to respond concurrently to several requests. The support for sharing of tables among the concurrent threads of a Tabling process is a desirable feature, to allow one of Tabling’s virtues, the re-use of co...

  14. Caching Patterns and Implementation

    OpenAIRE

    Octavian Paul ROTARU

    2006-01-01

    Repetitious access to remote resources, usually data, constitutes a bottleneck for many software systems. Caching is a technique that can drastically improve the performance of any database application, by avoiding multiple read operations for the same data. This paper addresses the caching problems from a pattern perspective. Both Caching and caching strategies, like primed and on demand, are presented as patterns and a pattern-based flexible caching implementation is proposed.The Caching pa...

  15. Service Systems Implementation

    CERN Document Server

    Demirkan, Haluk; Krishna, Vikas

    2011-01-01

    Service Systems Implementation provides the latest applications and practices aimed at improving the key performance indicators of service systems, especially those related to service quality, service productivity, regulatory compliance, and sustainable service innovation. The book presents action-oriented, application-oriented, design science-oriented (artifacts building: constructs, models, methods and instantiations) and case study-oriented research with actionable results by illustrating techniques that can be employed in large scale, real world examples. The case studies will help visuali

  16. Failures in implementation

    OpenAIRE

    Karamanof, M.

    1996-01-01

    The purpose of this essay is to propose a comprehensive legal theory of implementation allowing for a deeper understanding of the failures of contemporary Public Administration. Such a theory requires its proper methodology, which is, In fact, the missing link between administrative law and the so-called new sciences. The thesis takes the view that the systemic approach satisfies the above requirements, for it makes possible the broader concepti6n of law, viewed within It...

  17. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram;

    2010-01-01

    Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly...... variable. Generation of trial databases and/or biobanks originating in large randomized clinical trials has successfully increased the knowledge obtained from those trials. At the 10th Cardiovascular Trialist Workshop, possibilities and pitfalls in designing and accessing clinical trial databases were...... discussed by a group of trialists. This review focuses on the arguments for conducting posttrial database studies and presents examples of studies in which posttrial knowledge generation has been substantial. Possible strategies to ensure successful trial database or biobank generation are discussed, in...

  18. 25 CFR 11.314 - Jury trials.

    Science.gov (United States)

    2010-04-01

    ... Criminal Procedure § 11.314 Jury trials. (a) A defendant has a right, upon demand, to a jury trial in any criminal case: (1) That is punishable by a maximum sentence of one year incarceration; or (2) In which...

  19. Clinical Trials: Key to Medical Progress

    Science.gov (United States)

    Skip Navigation Bar Home Current Issue Past Issues Clinical Trials: Key to Medical Progress Past Issues / Summer 2008 ... this page please turn Javascript on. Photo iStock Clinical trials are research studies that test how well new ...

  20. Implementing PAT with Standards

    Science.gov (United States)

    Chandramohan, Laakshmana Sabari; Doolla, Suryanarayana; Khaparde, S. A.

    2016-02-01

    Perform Achieve Trade (PAT) is a market-based incentive mechanism to promote energy efficiency. The purpose of this work is to address the challenges inherent to inconsistent representation of business processes, and interoperability issues in PAT like cap-and-trade mechanisms especially when scaled. Studies by various agencies have highlighted that as the mechanism evolves including more industrial sectors and industries in its ambit, implementation will become more challenging. This paper analyses the major needs of PAT (namely tracking, monitoring, auditing & verifying energy-saving reports, and providing technical support & guidance to stakeholders); and how the aforesaid reasons affect them. Though current technologies can handle these challenges to an extent, standardization activities for implementation have been scanty for PAT and this work attempts to evolve them. The inconsistent modification of business processes, rules, and procedures across stakeholders, and interoperability among heterogeneous systems are addressed. This paper proposes the adoption of specifically two standards into PAT, namely Business Process Model and Notation for maintaining consistency in business process modelling, and Common Information Model (IEC 61970, 61968, 62325 combined) for information exchange. Detailed architecture and organization of these adoptions are reported. The work can be used by PAT implementing agencies, stakeholders, and standardization bodies.

  1. MDSplus Objects - Python Implementation

    International Nuclear Information System (INIS)

    MDSplus is a data acquisition and analysis software package used widely throughout the international fusion research community. During the past year, an important set of enhancements were designed under the project name of 'MDSobjects' which would provide a common, powerful application programming interface (API) to MDSplus in programming languages with object oriented capabilities. This paper will discuss the Python language implementation of this API and some of the capabilities that this implementation provides for data storage and retrieval using the MDSplus system. We have implemented a new MDSplus Python module which exposes the MDSplus objects features to the language. The internal MDSplus programming language, TDI, has also been enhanced to be able to invoke Python commands from the TDI language. Now that Python is aware of the complex data structures in MDSplus such as Signals, the language becomes a very good candidate for applications ranging from data acquisition device support to analysis and visualization. This document is composed of an abstract followed by the presentation slides. (authors)

  2. Image quality assurance in the prostate, lung, colorectal, and ovarian cancer screening trial network of the National Lung Screening Trial.

    Science.gov (United States)

    Moore, Stephen M; Gierada, David S; Clark, Kenneth W; Blaine, G James

    2005-09-01

    The National Lung Screening Trial is evaluating the effectiveness of low-dose spiral CT and conventional chest X-ray as screening tests for persons who are at high risk for developing lung cancer. This multicenter trial requires quality assurance (QA) for the image quality and technical parameters of the scans. The electronic system described here helps manage the QA process. The system includes a workstation at each screening center that de-identifies the data, a DICOM storage service at the QA Coordinating Center, and Web-based systems for presenting images and QA evaluation forms to the QA radiologists. Quality assurance data are collated and analyzed by an independent statistical organization. We describe the design and implementation of this electronic QA system, emphasizing issues relating to data security and privacy, the various obstacles encountered in the installation of a common system at different participating screening centers, and the functional success of the system deployed. PMID:15924251

  3. Strategies to improve retention in randomised trials

    OpenAIRE

    Brueton, V. C.; Tierney, J.; Stenning, S; Harding, S; Meredith, S.; Nazareth, I; Rait, G

    2013-01-01

    Background Loss to follow-up from randomised trials can introduce bias and reduce study power, affecting the generalisability, validity and reliability of results. Many strategies are used to reduce loss to follow-up and improve retention but few have been formally evaluated. Objectives To quantify the effect of strategies to improve retention on the proportion of participants retained in randomised trials and to investigate if the effect varied by trial strategy and trial setting. Search met...

  4. Sample Size Estimation in Clinical Trial

    OpenAIRE

    Tushar Vijay Sakpal

    2010-01-01

    Every clinical trial should be planned. This plan should include the objective of trial, primary and secondary end-point, method of collecting data, sample to be included, sample size with scientific justification, method of handling data, statistical methods and assumptions. This plan is termed as clinical trial protocol. One of the key aspects of this protocol is sample size estimation. The aim of this article is to discuss how important sample size estimation is for a clinical trial, and a...

  5. Data considerations in ischemic stroke trials

    OpenAIRE

    Liebeskind, David S.; Feldmann, Edward

    2014-01-01

    Data drive the analyses of any ischemic stroke trial, culminating in the main results and potential next steps. The distinct purpose of a given trial, advancing a novel treatment or examining routine clinical practice, determines the nature of essential data elements. Information gathering for an effective trial depends on ample data, adequate infrastructure, and properly planned statistical analyses. This review highlights the fact that successful future trials will require appropriate exper...

  6. Expectations from implementers

    International Nuclear Information System (INIS)

    Enrique Biurrun (DBE) presented the expectations from the implementer. He explained that the implementer needs a framework to successfully develop a repository which means the definition of requirements and guidance (for repository system development, analysis, licences, etc.) as well as the decision-making process (stepwise approach, roles of different players, etc.). He also needs a reasonable stability of the regulatory system. The regulatory framework should be developed in a clear, reasonable and consistent manner. In the context of the long duration of the project (100 years) there will be technological progress. In that context E. Biurrun asked what is the meaning of best practice. How can one deal with judgmental issues in a step-wise approach? Regulatory criteria and guidance must deal with the repository system for which an iterative process is necessary where dialogue is needed with the regulator despite the need to maintain his independence. The safety case, which is a periodic documentation of the status of the project, must provide a synthesis of the underlying scientific understanding and evidence and becomes part of the design process through feedback. E. Biurrun pointed out that safety is not calculated or assessed, but designed and built into the repository system (by geological and engineered barriers). He stressed the importance of the operational aspects since the implementer has to build and operate the repository safely. He asked the question: is it 'Ethical' to buy 'peace of mind' of some stakeholders with casualties of the implementer's staff because of mining accidents if the repository is left open during a phase of reversibility. The implementer needs dependable criteria, legal security and investment security. He interpreted the 'Precautionary principle' as meaning 'do it now'. Long-lasting solutions are very uncertain. Will we heave the money and the technology to do it later? He made some reflections regarding the ethical need to

  7. HIV/AIDS Clinical Trials Fact Sheet

    Science.gov (United States)

    HIV Prevention HIV/AIDS Clinical Trials (Last updated 9/15/2015; last reviewed 9/15/2015) Key Points HIV/AIDS clinical ... safe and effective in people. What is an HIV/AIDS clinical trial? HIV/AIDS clinical trials help ...

  8. Clinical Trials Management | Division of Cancer Prevention

    Science.gov (United States)

    Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials. Protocol Information Office The central clearinghouse for clinical trials management within the Division of Cancer Prevention.Read more about the Protocol Information Office. | Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials.

  9. Enhancing Adherence in Clinical Exercise Trials.

    Science.gov (United States)

    O'Neal, Heather A.; Blair, Steven N.

    2001-01-01

    Discusses exercise adherence from the perspective of adhering to an exercise treatment in a controlled trial, focusing on: adherence (to intervention and measurement); the development of randomized clinical trials; exemplary randomized clinical trials in exercise science (exercise training studies and physical activity interventions); and study…

  10. Trial-to-Trial Fluctuations in Attentional State and Their Relation to Intelligence

    Science.gov (United States)

    Unsworth, Nash; McMillan, Brittany D.

    2014-01-01

    Trial-to-trial fluctuations in attentional state while performing measures of intelligence were examined in the current study. Participants performed various measures of fluid and crystallized intelligence while also providing attentional state ratings prior to each trial. It was found that pre-trial attentional state ratings strongly predicted…

  11. Characteristics of successfully implemented telemedical applications

    Directory of Open Access Journals (Sweden)

    Engeseth Kjersti H

    2007-07-01

    Full Text Available Abstract Background There has been an increased interest in the use of telemedical applications in clinical practice in recent years. Considerable effort has been invested in trials and experimental services. Yet, surprisingly few applications have continued beyond the research and development phase. The aim of this study is to explore characteristics of successfully implemented telemedical applications. Methods An extensive search of telemedicine literature was conducted in order to identify relevant articles. Following a defined selection process, a small number of articles were identified that described characteristics of successfully implemented telemedical applications. These articles were analysed qualitatively, drawing on central procedures from Grounded Theory (GT, including condensation and categorisation. The analysis resulted in a description of features found to be of importance for a successful implementation of telemedicine. Subsequently, these features were discussed in light of Science and Technology studies (STS and the concept of 'social negotiation'. Results Telemedical applications introduced into routine practice are typically characterised by the following six features: 1 local service delivery problems have been clearly stated, 2 telemedicine has been seen as a benefit, 3 telemedicine has been seen as a solution to political and medical issues, 4 there was collaboration between promoters and users, 5 issues regarding organizational and technological arrangements have been addressed, and 6 the future operation of the service has been considered. Conclusion Our findings support research arguing that technologies are not fixed entities moving from invention through diffusion and into routine use. Rather, it is the interplay between technical and social factors that produces a particular outcome. The success of a technology depends on how this interplay is managed during the process of implementation.

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

    Science.gov (United States)

    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…

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

    Science.gov (United States)

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

    2011-01-01

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

  14. Initial Open Trial of a Computerized Behavioral Activation Treatment for Depression

    Science.gov (United States)

    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…

  15. Understanding cognitive processes behind acceptance or refusal of phase I trials.

    Science.gov (United States)

    Pravettoni, Gabriella; Mazzocco, Ketti; Gorini, Alessandra; Curigliano, Giuseppe

    2016-04-01

    Participation in phase I trials gives patients the chance to obtain control over their disease by trying an experimental therapy. The patients' vulnerability, the informed consent process aiming at understanding the purpose and potential benefits of the phase I trial, and the complexity of the studies may impact the patient's final decision. Emotionally difficult health conditions may induce patients to succumb to cognitive biases, allocating attention only on a part of the provided information. Filling the gap in patients' information process can foster the implementation of strategies to help physicians tailor clinical trials' communication providing personalized support and tailored medical information around patients' need, so avoiding cognitive biases in patients and improving informed shared decision quality. The aim of the present review article focuses on the analysis of cognitive and psychological factors that affect patients' decision to participate or not to early phase clinical trials. PMID:26852078

  16. Primary Care Physician-Pharmacist Collaborative Care Model: Strategies for Implementation.

    Science.gov (United States)

    Carter, Barry L

    2016-04-01

    The Collaboration Among Pharmacists and Physicians To Improve Outcomes Now (CAPTION) trial recently found that a pharmacist intervention for hypertension could be implemented in diverse medical offices. In this issue of Pharmacotherapy, the article by Brian Isetts and colleagues discusses the complexity of the patient population, the specific functions the pharmacists performed, and the time estimates from billing records used to quantify time spent during face-to-face patient encounters. This invited commentary will discuss findings from the CAPTION trial and provide recommendations for strategies to implement similar interventions for patients with other chronic medical conditions seen in primary care practices. PMID:26931738

  17. Enrolling adolescents in HIV vaccine trials: reflections on legal complexities from South Africa

    Directory of Open Access Journals (Sweden)

    Gray Glenda

    2007-05-01

    Full Text Available Abstract Background South Africa is likely to be the first country in the world to host an adolescent HIV vaccine trial. Adolescents may be enrolled in late 2007. In the development and review of adolescent HIV vaccine trial protocols there are many complexities to consider, and much work to be done if these important trials are to become a reality. Discussion This article sets out essential requirements for the lawful conduct of adolescent research in South Africa including compliance with consent requirements, child protection laws, and processes for the ethical and regulatory approval of research. Summary This article outlines likely complexities for researchers and research ethics committees, including determining that trial interventions meet current risk standards for child research. Explicit recommendations are made for role-players in other jurisdictions who may also be planning such trials. This article concludes with concrete steps for implementing these important trials in South Africa and other jurisdictions, including planning for consent processes; delineating privacy rights; compiling information necessary for ethics committees to assess risks to child participants; training trial site staff to recognize when disclosures trig mandatory reporting response; networking among relevant ethics commitees; and lobbying the National Regulatory Authority for guidance.

  18. What Are Clinical Trials? | NIH MedlinePlus the Magazine

    Science.gov (United States)

    ... of this page please turn Javascript on. Feature: Clinical Trials What Are Clinical Trials? Past Issues / Fall 2010 Table of Contents Clinical ... conducted all the time. The Different Phases of Clinical Trials Clinical trials related to drugs are classified into ...

  19. Implementing the ICPD's message.

    Science.gov (United States)

    Jain, A

    1995-01-01

    The International Conference on Population and Development held in Cairo in September 1994 recognized the need for reducing unwanted fertility and promoting smaller families within reproductive health services along with improving women's equality in education, health, and economic opportunity. The implementation of the main message would require an ideological transformation both for the population and for the development establishments. The implementation of a broadened population policy must incorporate the reduction of gender disparities as the primary goal. The problem is that the UNFPA has no influence over resources allocated to child health, female education, economic opportunities for women, or empowerment of women. Reproductive health and family planning programs should be integrated within the broader health services; however, reproductive health may not receive the desired high priority. Family planning programs are also expected to solve two problems: to improve individual well-being and to reduce overall fertility. Managers are likely to implement the reproductive health approach if it is a cost-effective way of reducing total fertility. However, no evidence exists to show that treating reproductive tract infections is a cost-effective way of reducing fertility. The primary objective of family planning programs should be empowerment of individuals to achieve their own reproductive goals in a healthful manner. Fertility reduction should be linked to fertility reduction by focusing on unwanted childbirth and to reproductive health services. The redesign of contraceptive services from a reproductive health perspective would deal with the contraindications of each method by developing standards for screening and focusing as well on the diagnosis and treatment of these conditions. The suggested role of the population sector in the tasks of development and family planning lies in promoting the main message to a wider national and international audience

  20. LSST operation simulator implementation

    Science.gov (United States)

    Delgado, Francisco; Cook, Kem; Miller, Michelle; Allsman, Robyn; Pierfederici, Francesco

    2006-06-01

    We have developed an operation simulator for the Large Synoptic Survey Telescope (LSST) that is an implementation in Python language using the SimPy extension, with a modular and object-oriented design. The main components include a telescope model, a sky model, a weather database for 3 sites, a scheduler and multiple observing proposals. All the proposals derive from a parent class which is fully configurable through about 75 parameters to implement a specific science survey. These parameters control the target selection region, the composition of the sequence of observations for each field, the timing restrictions and filter selection criteria of each observation, the lunation handling, seeing limits, etc. The current implemented proposals include Weak Lensing, Near Earth Asteroids, Supernova and Kuiper Belt Objects. The telescope model computes the slew time delay from the current position to any given target position, using a complete kinematic model for the mount, dome and rotator, as well as optics alignment corrections. The model is fully configurable through about 50 parameters. The scheduler module combines the information received from the proposals and the telescope model for selecting the best target at each moment, promoting targets that fulfill multiple surveys and storing all the simulator activities in a MySQL database for further analysis of the run. This scheduler is also configurable; for example, balancing the weight of the slew time delay in selecting the next field to observe. This simulator has been very useful in clarifying some of the technical and scientific capabilities of the LSST design, and gives a good baseline for a future observation scheduler.

  1. Pediatric Obstructive Uropathy: Clinical Trials

    International Nuclear Information System (INIS)

    As the powerful tools of molecular biology continue to delineate new concepts of pathogenesis of diseases, new molecular-level therapeutic modalities are certain to emerge. In order to design and execute clinical trials to evaluate outcomes of these new treatment modalities, we will soon need a new supply of investigators with training and experience in clinical research. The slowly-progressive nature of chronic pediatric kidney disease often results in diagnosis being made at a time remote from initial result, and the inherently slow rate of progression makes changes difficult to measure. Thus, development of molecular markers for both diagnosis and rate of progression will be critical to studies of new therapeutic modalities. We will review general aspects of clinical trials and will use current and past studies as examples to illustrate specific points, especially as these apply to chronic kidney disease associated with obstructive uropathy in children. (author)

  2. Quality of Variational Trial States

    CERN Document Server

    Lucha, Wolfgang; Lucha, Wolfgang; Schoberl, Franz F.

    1999-01-01

    Besides perturbation theory (which clearly requires the knowledge of the exact unperturbed solution), variational techniques represent the main tool for any investigation of the eigenvalue problem of some semibounded operator H in quantum theory. For a reasonable choice of the employed trial subspace of the domain of H, the lowest eigenvalues of H usually can be located with acceptable precision whereas the trial-subspace vectors corresponding to these eigenvalues approximate, in general, the exact eigenstates of H with much less accuracy. Accordingly, various measures for the accuracy of the approximate eigenstates derived by variational techniques are scrutinized. In particular, the matrix elements of the commutator of the operator H and (suitably chosen) different operators with respect to degenerate approximate eigenstates of H obtained by variational methods are proposed as new criteria for the accuracy of variational eigenstates. These considerations are applied to precisely that Hamiltonian for which t...

  3. Priming a Pilot Implementation

    DEFF Research Database (Denmark)

    Hansen, Magnus; Ie Pedersen, Maria

    Abstract. We report on the initial findings of an action research study about effects specifications. It is a part of larger IS pilot implementation project conducted in the Danish healthcare sector. Through interviews and a workshop we have identified and specified the main effects that comprise...... the basis for the evaluation of the project. The study indicates that cross-organisational effects specifications cause a significant number of effects. To further prioritize these we argue that both interview and workshop must be facilitated as mutual learning processes between interviewer and...

  4. Spatial grammar implementation

    DEFF Research Database (Denmark)

    McKay, Alison; Chase, Scott Curland; Shea, Kristina;

    2012-01-01

    fluid, demands conceptual design tools that support designers’ ways of thinking and working, and enhance creativity, for example, by offering design alternatives, difficult or not, possible without the use of such tools. The potential of spatial grammars as a technology to support such design tools has...... been demonstrated through experimental research prototypes since the 1970s. In this paper, we provide a review of recent spatial grammar implementations, which were presented in the Design Computing and Cognition 2010 workshop on which this paper is based, in the light of requirements for conceptual...

  5. Mobile Portal Implementation Strategy

    DEFF Research Database (Denmark)

    Gao, Ping; Damsgaard, Jan

    2005-01-01

    Mobile portal plays an important role in mobile commerce market. Current literature focuses on static analysis on the value chain of mobile portals. This article provides a dynamic perspective on mobile portal strategy. Drawing upon network economics, we describe mobile portal implementation...... as a fourphase process. In different phase, a portal provider has various challenges to overcome and adopt diverse strategies, and correspondingly the regulator has different foci. The conceptual framework proposed in this article offers a basis for further analyses on the market dynamics of mobile commerce...

  6. MONA Implementation Secrets

    DEFF Research Database (Denmark)

    Klarlund, Nils; Møller, Anders; Schwartzbach, Michael Ignatieff

    2002-01-01

    period of six years. Compared to the first naive version, the present tool is faster by several orders of magnitude. This speedup is obtained from many different contributions working on all levels of the compilation and execution of formulas. We present a selection of implementation "secrets" that have...... been discovered and tested over the years, including formula reductions, DAGification, guided tree automata, three-valued logic, eager minimization, BDD-based automata representations, and cache-conscious data structures. We describe these techniques and quantify their respective effects by...

  7. Human clinical trials in antiepileptogenesis

    OpenAIRE

    Mani, Ram; Pollard, John; Dichter, Marc A.

    2011-01-01

    Blocking the development of epilepsy (epileptogenesis) is a fundamental research area with the potential to provide large benefits to patients by avoiding the medical and social consequences that occur with epilepsy and lifelong therapy. Human clinical trials attempting to prevent epilepsy (antiepileptogenesis) have been few and universally unsuccessful to date. In this article, we review data about possible pathophysiological mechanisms underlying epileptogenesis, discuss potential intervent...

  8. -ctgov-: A suite of Stata commands for reporting trial results to ClinicalTrials.gov

    OpenAIRE

    Phil Schumm; Theodore Karrison

    2014-01-01

    In response to the 1997 Food and Drug Administration Modernization Act (FDAMA), the National Institutes of Health (NIH) established ClinicalTrials.gov, an online, publicly-accessible registry for clinical trials. The 2007 Food and Drug Administration Amendments Act (FDAAA) broadened the scope of eligible trials, added outcomes reporting as a requirement, and established penalties for non-compliance. Although ClinicalTrials.gov increased the transparency with which clinical trials are conducte...

  9. Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis.

    OpenAIRE

    Ross, Joseph S.; Mulvey, Gregory K.; Hines, Elizabeth M.; Nissen, Steven E.; Krumholz, Harlan M.

    2009-01-01

    BACKGROUND: ClinicalTrials.gov is a publicly accessible, Internet-based registry of clinical trials managed by the US National Library of Medicine that has the potential to address selective trial publication. Our objectives were to examine completeness of registration within ClinicalTrials.gov and to determine the extent and correlates of selective publication. METHODS AND FINDINGS: We examined reporting of registration information among a cross-section of trials that had been registered at ...

  10. Automated Information Extraction of Key Trial Design Elements from Clinical Trial Publications

    OpenAIRE

    de Bruijn, Berry; Carini, Simona; Kiritchenko, Svetlana; Martin, Joel; Sim, Ida

    2008-01-01

    Clinical trials are one of the most valuable sources of scientific evidence for improving the practice of medicine. The Trial Bank project aims to improve structured access to trial findings by including formalized trial information into a knowledge base. Manually extracting trial information from published articles is costly, but automated information extraction techniques can assist. The current study highlights a single architecture to extract a wide array of information elements from full...

  11. Potential Representation - Global vs. Local Trial Functions

    Science.gov (United States)

    Michel, Volker

    2014-05-01

    Many systems of trial functions are available for representing potential fields on the sphere or parts of the sphere. We distinguish global trial functions (such as spherical harmonics) from localized trial functions (such as spline basis functions, scaling functions, wavelets, and Slepian functions). All these systems have their own pros and cons. We discuss the advantages and disadvantages of several selected systems of trial functions and propose criteria for their applicability. Moreover, we present an algorithm which is able to combine different types of trial functions. This yields a sparser solution which combines the features of the different basis systems which are used.

  12. The DiaS trial

    DEFF Research Database (Denmark)

    Andreasson, Kate; Krogh, Jesper; Rosenbaum, Bent;

    2014-01-01

    BACKGROUND: In Denmark 8,000 to 10,000 people will attempt suicide each year. The Centre of Excellence in Suicide Prevention in the Capital Region of Denmark is treating patients with suicidal behavior, and a recent survey has shown that 30% of the patients are suffering from borderline personali...... measured at week 28. Other exploratory outcomes are included such as severity of symptoms, suicide intention and ideation, depression, hopelessness, self-esteem, impulsivity, anger, and duration of respective treatments. TRIAL REGISTRATION: Clinical Trial.gov: NCT01512602....... disorder. The majority of patients (70% to 75%) with borderline personality disorder have a history of deliberate self-harm and 10% have a lifetime risk to die by suicide. The DiaS trial is comparing dialectical behavior therapy with collaborative assessment and management of suicidality......-informed supportive psychotherapy, for the risk of repetition of deliberate self-harm in patients with a recent suicide attempt and personality traits within the spectrum of borderline personality disorder. Both treatments have previously shown effects in this group of patients on suicide ideation and self...

  13. Clinical trials and gender medicine

    Directory of Open Access Journals (Sweden)

    Mariarita Cassese

    2011-01-01

    Full Text Available Women use more medicines than men because they fall ill more often and suffer more from chronic diseases, but also because women pay more attention to their health and have more consciousness and care about themselves. Although medicines can have different effects on women and men, women still represent a small percentage in the first phases of trials (22% which are essential to verify drugs dosage, side effects, and safety. Even though women are more present in trials, studies results are not presented with a gender approach. This situation is due to educational, social, ethical and economical factors. The scientific research must increase feminine presence in clinical trials in order to be equal and correct, and all the key stakeholder should be involved in this process. We still have a long way to cover and it doesn't concern only women but also children and old people. The aim is to have a medicine not only illness-focused but patient-focused: a medicine able to take into consideration all the patient characteristics and so to produce a really personalized therapy. What above described is part of the reasons why in 2005 was founded the National Observatory for Women's Health (Osservatorio Nazionale sulla Salute della Donna, ONDa which promotes a gender health awareness and culture in Italy, at all the levels of the civil and scientific society.

  14. Market Trials of Irradiated Spices

    International Nuclear Information System (INIS)

    Full text: The objectives of the experiment were to disseminate irradiated retail foods to the domestic publics and to test consumer acceptance on irradiated ground chilli and ground pepper. Market trials of irradiated ground chilli and ground pepper were carried out at 2 local markets and 4 in Bangkok and Nontaburi in 2005-2007. Before the start of the experiment, processing room, gamma irradiation room and labels of the products were approved by Food and Drug Administration, Thailand. 50 grams of irradiated products were packaged in plastic bags for the market trials. 688 and 738 bags of ground chilli and ground pepper were sold, respectively. Questionnaires distributed with the products were commented by 59 consumers and statistically analyzed by experimental data pass program. 88.1 and 91.4 percents of the consumers were satisfied with the quality and the price, respectively. 79.7% of the consumers chose to buy irradiated ground chilli and ground pepper because they believed that the quality of irradiated products were better than that of non-irradiated ones. 91.5% of the consumers would certainly buy irradiated chilli and pepper again. Through these market trials, it was found that all of the products were sold out and the majority of the consumers who returned the questionnaires was satisfied with the irradiated ground chilli and ground pepper and also had good attitude toward irradiated foods

  15. Acceptance Checklist for Clinical Effectiveness Pilot Trials: a systematic approach.

    OpenAIRE

    Charlesworth, G.; Burnell, K.; Hoe, J.; Orrell, M; Russell, I

    2013-01-01

    Conducting a pilot trial is important in preparing for, and justifying investment in, the ensuing larger trial. Pilot trials using the same design and methods as the subsequent main trial are ethically and financially advantageous especially when pilot and main trial data can be pooled. For explanatory trials in which internal validity is paramount, there is little room for variation of methods between the pilot and main trial. For pragmatic trials, where generalisability or external validity...

  16. Implementation: Measuring and Explaining the Fidelity of CSR Implementation

    Science.gov (United States)

    Kurki, Anja; Boyle, Andrea; Aladjem, Daniel K.

    2006-01-01

    Comprehensive school reform (CSR) is only as effective as its implementation. By using data collected for the National Longitudinal Evaluation of Comprehensive School Reform (NLECSR), this article explores the factors that predict CSR model implementation and the ways that CSR model implementation varies. We found little difference in the fidelity…

  17. The OPERA trial: a protocol for the process evaluation of a randomised trial of an exercise intervention for older people in residential and nursing accommodation

    Directory of Open Access Journals (Sweden)

    Parsons Suzanne

    2011-02-01

    Full Text Available Abstract Background The OPERA trial is large cluster randomised trial testing a physical activity intervention to address depression amongst people living in nursing and residential homes for older people. A process evaluation was commissioned alongside the trial and we report the protocol for this process evaluation. Challenges included the cognitive and physical ability of the participants, the need to respect the privacy of all home residents, including study non-participants, and the physical structure of the homes. Evaluation activity had to be organised around the structured timetable of homes, leaving limited opportunities for data collection. The aims of this process evaluation are to provide findings that will assist in the interpretation of the clinical trial results, and to inform potential implementation of the physical activity intervention on a wider scale. Methods/design Quantitative data on recruitment of homes and individuals is being collected. For homes in the intervention arm, data on dose and fidelity of the intervention delivered; including individual rates of participation in exercise classes are collected. In the control homes, uptake and delivery of depression awareness training is monitored. These data will be combined with qualitative data from an in-depth study of a purposive sample of eight homes (six intervention and two control. Discussion Although process evaluations are increasingly funded alongside trials, it is still rare to see the findings published, and even rarer to see the protocol for such an evaluation published. Process evaluations have the potential to assist in interpreting and understanding trial results as well as informing future roll-outs of interventions. If such evaluations are funded they should also be reported and reviewed in a similar way to the trial outcome evaluation. Trial Registration ISRCTN No: ISRCTN43769277

  18. Priming a Pilot Implementation

    DEFF Research Database (Denmark)

    Hansen, Magnus Rotvit Perlt; Pedersen, Maria Ie

    2011-01-01

    Abstract. We report on the initial findings of an exploratory action research study about effects specifications using the systems development method Effects-driven IT development. It is part of a larger IS pilot implementation project conducted in the Danish healthcare sector. Through interviews...... and a workshop we have identified and specified effects that comprise the basis for an evaluation of the project between several organisational agents with diverse professional backgrounds. Gathering organisational participants at a workshop with a common goal of discussing and prioritizing a finished...... list of effects has proved to be a valuable approach to create mutual learning process amongst the participants and the facilitators of the workshop. The challenges we experienced during the effects specification process were to balance a dichotomous focus between on one hand the visions of the...

  19. Implementing AIDS Education

    Directory of Open Access Journals (Sweden)

    Grace C. Huerta

    1996-08-01

    Full Text Available The world has been challenged by the AIDS epidemic for 15 years. In 1985, the U.S. Department of Health and Human Services, Centers for Disease Control, allocated funds to all state departments of education to assist schools in the development of AIDS education policies and programs. Yet, these policies do not ensure that all students receive effective AIDS education. On September 21, 1991, the Arizona Legislature passed Senate Bill 1396, which requires public schools to annually provide AIDS education in grades K-12. The bill was rescinded in 1995. With prohibitive curriculum guidelines, limited teacher training opportunities and tremendous instructional demands, this educational policy was implemented in disparate forms. By examining the perspectives of the Arizona educators (representing three school districts, this qualitative study reveals how teachers ultimately controlled the delivery and nature of AIDS instruction based upon personal values, views of teacher roles, and their interpretation of the mandate itself.

  20. Environmental Implementation Plan

    Energy Technology Data Exchange (ETDEWEB)

    1993-03-15

    The purpose of the Environmental Implementation Plan (EIP) is to show the current and future (five years) environmental plans from individual site organizations and divisions, as well as site environmental programs and initiatives which are designed to protect the environment and meet or exceed changing environmental/regulatory requirements. Communicating with site organizations, departments, and committees is essential in making the site`s environmental-planning process work. The EIP gives the site the what, when, how, and why for environmental requirements. Through teamwork and proactive planning, a partnership for environmental excellence is formed to achieve the site vision for SRS to become the recognized model for Environmental Excellence in the Department of Energy`s Nuclear Weapons Complex.

  1. Environmental Implementation Plan

    Energy Technology Data Exchange (ETDEWEB)

    1993-03-15

    The purpose of the Environmental Implementation Plan (EIP) is to show the current and future (five years) environmental plans from individual site organizations and divisions, as well as site environmental programs and initiatives which are designed to protect the environment and meet or exceed changing environmental/regulatory requirements. Communicating with site organizations, departments, and committees is essential in making the site's environmental-planning process work. The EIP gives the site the what, when, how, and why for environmental requirements. Through teamwork and proactive planning, a partnership for environmental excellence is formed to achieve the site vision for SRS to become the recognized model for Environmental Excellence in the Department of Energy's Nuclear Weapons Complex.

  2. Implementing Sakai OAE

    Directory of Open Access Journals (Sweden)

    Slobodan Jovanovic

    2013-03-01

    Full Text Available Abstract—Sakai OAE (Open Academy Environment, former Sakai 3, is the second generation of Sakai CLE (Collaboration and Learning Environment. It was developed with new vision for academic collaboration (collaboration in education and research. They moved from name Sakai 3 because the community thinks this is completely new product category just like Sakai CLE distinguished itself from other LMS. Sakai OAE is not jet another LMS. It has LMS functionality, but it allows community to expand boundaries of one university. This paper explains how to implement Sakai OLE. Content is of primary interest in Sakai OAE. Content creation and use, Creating documents, Course creation, etc., are demonstrated here in this paper.

  3. Implementing Software Defined Radio

    CERN Document Server

    Grayver, Eugene

    2013-01-01

    Software Defined Radio makes wireless communications easier, more efficient, and more reliable. This book bridges the gap between academic research and practical implementation. When beginning a project, practicing engineers, technical managers, and graduate students can save countless hours by considering the concepts presented in these pages. The author covers the myriad options and trade-offs available when selecting an appropriate hardware architecture. As demonstrated here, the choice between hardware- and software-centric architecture can mean the difference between meeting an aggressive schedule and bogging down in endless design iterations. Because of the author’s experience overseeing dozens of failed and successful developments, he is able to present many real-life examples. Some of the key concepts covered are: Choosing the right architecture for the market – laboratory, military, or commercial Hardware platforms – FPGAs, GPPs, specialized and hybrid devices Standardization efforts to ens...

  4. Environmental Implementation Plan

    International Nuclear Information System (INIS)

    The purpose of the Environmental Implementation Plan (EIP) is to show the current and future (five years) environmental plans from individual site organizations and divisions, as well as site environmental programs and initiatives which are designed to protect the environment and meet or exceed changing environmental/regulatory requirements. Communicating with site organizations, departments, and committees is essential in making the site's environmental-planning process work. The EIP gives the site the what, when, how, and why for environmental requirements. Through teamwork and proactive planning, a partnership for environmental excellence is formed to achieve the site vision for SRS to become the recognized model for Environmental Excellence in the Department of Energy's Nuclear Weapons Complex

  5. Implementing a hydrogen economy

    Directory of Open Access Journals (Sweden)

    James A Ritter

    2003-09-01

    In recent years, months, weeks, and even days, it has become increasingly clear that hydrogen as an energy carrier is ‘in’ and carbonaceous fuels are ‘out’1. The hydrogen economy is coming, with the impetus to transform our fossil energy-based society, which inevitably will cease to exist, into a renewable energy-based one2. However, this transformation will not occur overnight. It may take several decades to realize a hydrogen economy. In the meantime, research and development is necessary to ensure that the implementation of the hydrogen economy is completely seamless, with essentially no disruption of the day-to-day activities of the global economy. The world has taken on a monumental, but not insurmountable, task of transforming from carbonaceous to renewable fuels, with clean burning, carbon dioxide-free hydrogen as the logical choice.

  6. Training Issues in ERP Implementations

    OpenAIRE

    Iuliana DOROBAT (SCORTA); Floarea NASTASE

    2012-01-01

    One of the critical success factors (CSF) of an ERP (Enterprise Resource Planning) implementation project is user training. In consequence, in this paper we focus our attention on compiling a list of CSFs that affect the ERP implementation training phase. Then we analyzed the training methods used in ERP implementations in order to provide better solutions than the ones identified in the IS literature. We studied the documentation of several implementation projects conducted at a Romanian ERP...

  7. Implementing New Ways of Working

    DEFF Research Database (Denmark)

    Granlien, Maren Sander; Hertzum, Morten

    2009-01-01

    Successful deployment of information technology (IT) involves implementation of new ways of working. Under-recognition of this organizational element of implementation entails considerable risk of not attaining the benefits that motivated deployment, yet knowledge of how to work systematically with...... interventions have ended. We discuss the implications of these results for efforts to work systematically with the organizational implementation of IT systems....

  8. Logistical and financial obstacles for endovascular therapy of acute stroke implementation.

    Science.gov (United States)

    Schellinger, Peter D; Köhrmann, Martin; Nogueira, Raul G

    2016-07-01

    After publication of the recent positive randomized clinical endovascular trials, several questions and obstacles for wide spread implementation remain. We address specific issues namely efficacy, safety, logistics, timing, sedation, numbers, imaging, manpower, centers, geographics, and economical aspects of endovascular therapy. As we move forward, a high degree of collaboration will be crucial to implement a therapy with established overwhelming treatment efficacy for severe acute stroke patients. PMID:27016510

  9. Patient-Reported Outcomes in Metastatic Breast Cancer: A Review of Industry-Sponsored Clinical Trials

    Science.gov (United States)

    Krohe, Meaghan; Hao, Yanni; Lamoureux, Roger E.; Galipeau, Nina; Globe, Denise; Foley, Catherine; Mazar, Iyar; Solomon, Jeffrey; Shields, Alan L.

    2016-01-01

    INTRODUCTION Patient-reported outcome (PRO) measures serve to capture vital patient information not otherwise obtained by primary study endpoints. This paper examines how PROs are utilized as endpoints in industry-sponsored metastatic breast cancer clinical trials. METHODS A search was conducted in the clinicaltrials.gov web site for trials involving common treatments for metastatic breast cancer. Thirty-eight clinical trials were identified which included a PRO endpoint in the study, and data were extracted and summarized. RESULTS Overall, 17 unique PRO questionnaires and 14 concepts of measurement were identified as secondary or exploratory endpoints. The Functional Assessment of Cancer Therapy—Breast was the most frequently utilized questionnaire, commonly implemented to assess quality of life. The EORTC QLQ-C30 was also frequently used to measure quality of life or pain. CONCLUSION This review shares insights into the role of PROs in trials for metastatic breast cancer from which treatment developers and other stakeholders can enhance successful implementation of the patient voice into future trials. PMID:27441001

  10. Contraceptive development and clinical trials.

    Science.gov (United States)

    Fraser, I S

    1986-02-01

    This article provides an overview of the contraceptive development process, with particular emphasis on the importance of clinical trials. Development of a new contraceptive drug begins with chemical synthesis of a large number of substances that may have antifertility effects. Before human trials are considered, drugs must undergo a complex process of animal toxicology testing. Such studies assess acute, subacute, and chronic toxicity. Once a drug has passed the initial screening process, human testing must follow a logical sequence of clinical trials: phase I, pharmacology testing; phase II, initial assessment of efficacy, safety, acceptability, and ease of use; phase III, acurate assessment of efficacy, side effects, and reasons for discontinuation under controlled conditions; and phase IV, evaluation of effectiveness under field conditions. When these have been satisfactorily completed, a detailed marketing application must be submitted to the drug regulatory agency in each country. The process of assessment of the application often takes as long as 2 years. Once marketing approval has been received, there is still a need for postmarketing surveillance of the performance of the new contraceptive method. In many cases, a careful program of training is required. Among the research and recording strategies for postmarketing surveillance are voluntary recording of possible adverse reactions, longterm prospective cohort studies, retrospective case-control studies, and registered release. As controls on the safety and performance of new contraceptive methods are being tightened, the time scale and costs of development are increasing. The time from the 1st synthesis of a drug to marketing approval often takes 13-14 years and costs US$25-50 million. Since the patent life of a new substance is limited to 17 years in most countries, pharmaceutical companies have little time to recoup development costs, which has caused fewer new methods to be developed. PMID:3708511

  11. Pharmacogenetics: implementing personalized medicine.

    Science.gov (United States)

    Mini, Enrico; Nobili, Stefania

    2009-01-01

    approach has helped unravel genetic variants that influence clinical drug responsiveness, gene-wide association studies have recently gained attention as they enable to associate specific genetic variants or quantitative differences in gene expression with drug response.Although research findings are accumulating, most of the potential of pharmacogenetics and pharmacogenomics remains to be explored and must be validated in prospective randomized clinical trials.The genetic and molecular foundations of personalized medicine appear solid and evidence indicates its growing importance in healthcare. PMID:22461093

  12. Melanoma vaccines: trials and tribulations

    Directory of Open Access Journals (Sweden)

    Dillman RO

    2013-10-01

    Full Text Available Robert O Dillman1,21Hoag Cancer Institute and Hoag Institute for Research and Education, Newport Beach, CA, USA; 2University of California Irvine, Irvine, CA, USAAbstract: Metastatic melanoma has been a target of immunotherapy for more than 4 decades. Three immunotherapeutics have received regulatory approval for treating melanoma: interferon-alpha, interleukin-2, and ipilimumab. The antitumor mechanisms of these products depend on enhancing existing immune responses, including autoimmune effects. The combination of autologous, cytotoxic T-lymphocytes plus high-dose interleukin-2 is a promising patient-specific therapy, but has limited clinical application. Other approaches include vaccines targeting melanoma-associated antigens, and patient-specific vaccines that utilize autologous tumor. Non-patient-specific vaccine approaches target melanocyte differentiation antigens (eg, tyrosinase, Melan-A, gp100, antigens identified by cytotoxic T-lymphocytes (eg, NY-Eso-1, Melan-A/Mart-1, Mage-3, and antigens originally identified by murine monoclonal antibodies (gangliosides, gp97, gp225. Self-renewing cells in tumor cell lines may represent tumor stem cells, but vaccines derived from allogeneic tumor cell lines have yielded disappointing results in randomized trials. Patient-specific vaccines can be derived from bulk autologous tumor or autologous tumor cell lines, and intratumoral injections of immunostimulatory fusion products have shown promise. While technically more complex to manufacture, patient-specific vaccines derived from autologous tumor cell lines have the potential to target tumor stem cells and overcome interpatient tumor cell heterogeneity. This article reviews sources of melanoma-associated antigens, costimulatory agents, and clinical trial results for various melanoma vaccines. Comparing Phase II trials is difficult because of the wide range of vaccine strategies and the differences in study patient populations; therefore, randomized

  13. The L'Aquila trial

    OpenAIRE

    Cocco, M.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione Roma1, Roma, Italia; Cultrera, G.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione Roma1, Roma, Italia; Amato, A.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione CNT, Roma, Italia; Braun, T.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione Roma1, Roma, Italia; Cerase, A.; Dipartimento di Comunicazione e Ricerca Sociale, Univ. La Sapienza, Roma, Italy; Margheriti, L.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione CNT, Roma, Italia; Bonaccorso, A.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione Catania, Catania, Italia; Demartin, M..; Istituto Nazionale di Geofisica e Vulcanologia, Sezione CNT, Roma, Italia; De Martini, P. M.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione Roma1, Roma, Italia; Galadini, F.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione Roma1, Roma, Italia; Meletti, C.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione Milano-Pavia, Milano, Italia; Nostro, C.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione CNT, Roma, Italia; Pacor, F.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione Milano-Pavia, Milano, Italia; Pantosti, D.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione Roma1, Roma, Italia; Pondrelli, S.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione Bologna, Bologna, Italia

    2015-01-01

    The first stage of the trial in L’Aquila (Italy) ended with a conviction of seven experts, convened by the head of Civil Protection on 31 March 2009, for multiple manslaughter and serious injuries. They were sentenced to six years in jail, perpetual interdiction from public office and a fine of several million euros to be paid to the victims of the earthquake of 6 April 2009 (moment magnitude 6.3) for having caused, by their negligent conduct, the death of 29 persons and the injury of seve...

  14. Lessons from the SYNTAX trial

    OpenAIRE

    Alamri, Hussein S.; Alotaiby, Mohammed; ALmoghairi, Abdulrahman; El Oakley, Rieda M.

    2010-01-01

    Despite the fact that CABG is the standard of care for patients with multivessel coronary arteries and/or left main stem stenosis, PCI has become a rival to CABG in patients with multivessel coronary artery disease or left main disease. However, the need for repeat revascularization, in-stent stenosis and thrombosis remain the achilis heal of PCI. SYNTAX trial randomized patients with left main disease and/or three-vessel disease to PCI with TAXus stent or CABG with the concept that PCI is no...

  15. Juvenile Competency to Stand Trial.

    Science.gov (United States)

    Stepanyan, Sofia T; Sidhu, Shawn S; Bath, Eraka

    2016-01-01

    Competency to stand trial is interpreted as a protected due process right for all defendants and is defined as a defendant's fundamental knowledge and understanding of the criminal charges being filed, roles and procedures within the courtroom, and a general ability to work with the defense counsel. Questions of competency are most often raised by the judge, defense, or the prosecution, and competency evaluations are most often completed by psychiatrists or psychologists with forensic training or work experience. Mental illness, intellectual disability, developmental disorders, and developmental immaturity are the 4 main factors considered in most juvenile competency evaluations. PMID:26593118

  16. Mobiilipeligrafiikan optimointi : Case: Trials Frontier

    OpenAIRE

    Palmi, Daniel

    2013-01-01

    Opinnäytetyön tavoitteena on tuoda esille merkittävimmät tekniikat ja seikat peligrafiikan optimointiin 3d-graafikon näkökulmasta. Oppimani tekniikat liittyvät tiiviisti Trials Frontier – mobiilipeliin, joka on kirjoitushetkellä kehitteillä Redlynx Ubisoft -studiossa. Olen projektis-sa 3d-graafikkona ja luonut peliin suurimman osan 3d-objekteista. Projektin parissa on työn kautta tullut opittua monia tekniikoita reaaliaikaisen grafiikan optimointiin ja esitän tässä opinnäytetyössä keskeisimmä...

  17. What Difference Does Patient and Public Involvement Make and What Are Its Pathways to Impact? Qualitative Study of Patients and Researchers from a Cohort of Randomised Clinical Trials.

    Directory of Open Access Journals (Sweden)

    Louise Dudley

    Full Text Available Patient and public involvement (PPI is advocated in clinical trials yet evidence on how to optimise its impact is limited. We explored researchers' and PPI contributors' accounts of the impact of PPI within trials and factors likely to influence its impact.Semi-structured qualitative interviews with researchers and PPI contributors accessed through a cohort of randomised clinical trials. Analysis of transcripts of audio-recorded interviews was informed by the principles of the constant comparative method, elements of content analysis and informant triangulation.We interviewed 21 chief investigators, 10 trial managers and 17 PPI contributors from 28 trials. The accounts of informants within the same trials were largely in agreement. Over half the informants indicted PPI had made a difference within a trial, through contributions that influenced either an aspect of a trial, or how researchers thought about a trial. According to informants, the opportunity for PPI to make a difference was influenced by two main factors: whether chief investigators had goals and plans for PPI and the quality of the relationship between the research team and the PPI contributors. Early involvement of PPI contributors and including them in responsive (e.g. advisory groups and managerial (e.g. trial management groups roles were more likely to achieve impact compared to late involvement and oversight roles (e.g. trial steering committees.Those seeking to enhance PPI in trials should develop goals for PPI at an early stage that fits the needs of the trial, plan PPI implementation in accordance with these goals, invest in developing good relationships between PPI contributors and researchers, and favour responsive and managerial roles for contributors in preference to oversight-only roles. These features could be used by research funders in judging PPI in trial grant applications and to inform policies to optimise PPI within trials.

  18. A concept for trial institutions focussing on randomised controlled trials in surgery

    Directory of Open Access Journals (Sweden)

    Büchler Markus W

    2008-01-01

    Full Text Available Abstract Background Although considered the reference standard for generating valid scientific evidence of a treatment's benefits and harms, the number of Randomised Controlled Trials (RCT comparing surgical techniques remains low. Much effort has been made in order to overcome methodological issues and improve quality of RCTs in surgery. To the present there has been, however, only little emphasis on development and maintenance of institutions for implementation of adequately designed and conducted surgical RCTs. Mehods/Design Description of the developments in surgical RCT infrastructure in Germany between 2001 and 2006. Cross sectional evaluation of completed and ongoing surgical RCTs within the German Surgical Society and the Clinical Study Centre, Department of Surgery, University of Heidelberg. Results Foundation of a national Clinical Trial Centre (CTC for the organisation of multi-centre RCTs in the surgical setting (Study Center of the German Surgical Society, SDGC. Establishment of a network of CTCs with affiliated Clinical Sites (CSs to enhance patient recruitment and shorten the duration of RCTs. Since its foundation four surgical RCTs with a total sample size of 1650 patients (1006 of these randomised have been supervised by the SDGC with 35 CSs involved in patient recruitment. Five further CTCs were set up in 2006. Together with their affiliated CSs a network has been organised providing improved conditions for the conduction of surgical RCTs. Conclusion Improvement of infrastructure substantially facilitates integration of RCTs into routine surgical practice. A network of collaborating CTCs and CSs can provide an adequate infrastructure for the conduction of multi-centre RCTs.

  19. Methodological considerations for a randomised controlled trial of podiatry care in rheumatoid arthritis: lessons from an exploratory trial

    Directory of Open Access Journals (Sweden)

    Helliwell Philip S

    2007-11-01

    Full Text Available Abstract Background Whilst evidence exists to support the use of single treatments such as orthoses and footwear, the effectiveness of podiatry-led care as a complex intervention for patients with rheumatoid arthritis (RA related foot problems is unknown. The aim of this study was to undertake an exploratory randomised controlled parallel arm clinical trial (RheumAFooT to inform the design and implementation of a definitive trial and to understand the potential benefits of this care. Methods Patients with a definite diagnosis of RA, stable drug management 3 months prior to entry, and a current history of foot problems (pain, deformity, stiffness, skin or nail lesions, or footwear problems were recruited from a hospital outpatient rheumatology clinic and randomised to receive 12 months of podiatry treatment or no care. The primary outcome was change in foot health status using the impairment/footwear (LFISIF and activity limitation/participation restriction (LFISAP subscales of the Leeds Foot Impact Scale. Disease Activity Score (DAS, Health Assessment Questionnaire (HAQ score and walking speed (m/s were also recorded. Results Of the 80 patients identified, 64 patients were eligible to participate in the pilot and 34 were recruited. 16 patients were randomised to receive podiatry led foot care and 18 received no care. Against a backdrop of stable disease (DAS and HAQ scores, there was a statistically significant between group difference in the change in foot health status for foot impairment (LFISIF but not activity/participation (LFISAP or function (walking speed over 12 months. In the podiatry arm, 1 patient declined treatment following randomisation (did not want additional hospital visits and 3 self-withdrew (lost to follow-up. Patients received an average of 3 consultations for assessment and treatment comprising routine care for skin and nail lesions (n = 3, foot orthoses (n = 9, footwear referral to the orthotist (n = 5, and ultrasound

  20. Trial and Numerical Analysis of Specimen Pipelay

    Institute of Scientific and Technical Information of China (English)

    何炎平; 邓德衡; 谭家华; 顾敏童

    2002-01-01

    Subsea pipelay has a relatively long history. In recent years, there has been a domestic need for the laying of largediameter thin wall pipes. A land-based trial for the large diameter thin wall specimen pipe is described in this paper. Re-gression analysis is performed for the trial data and the formula derived can express the trial data very well. Numericalanalysis is adopted to compute various trial conditions. Then the numerical model is revised with the trial results, whichare consistent with each other. After summarization of the results of trial and numerical analysis, the characteristics aredescribed of the spatial configuration during the laying of the pipe and it is concluded that the maximum strain appearsaround the center of the raised pipeline. In the end, a reference standard, which limits the maximum stress below theyield stress is provided.

  1. Civil society perspectives on negative biomedical HIV prevention trial results and implications for future trials.

    Science.gov (United States)

    Essack, Zaynab; Koen, Jennifer; Slack, Catherine; Lindegger, Graham; Newman, Peter A

    2012-01-01

    Community engagement is crucial to ongoing development and testing of sorely needed new biomedical HIV prevention technologies. Yet, negative trial results raise significant challenges for community engagement in HIV prevention trials, including the early termination of the Cellulose Sulfate microbicide trial and two Phase IIb HIV vaccine trials (STEP and Phambili). The present study aimed to explore the perspectives and experiences of civil society organization (CSO) representatives regarding negative HIV prevention trial results and perceived implications for future trials. We conducted in-depth interviews with 14 respondents from a broad range of South African and international CSOs, and analyzed data using thematic analysis. CSO representatives reported disappointment in response to negative trial results, but acknowledged such outcomes as inherent to clinical research. Respondents indicated that in theory negative trial results seem likely to impact on willingness to participate in future trials, but that in practice people in South Africa have continued to volunteer. Negative trial results were described as having contributed to improving ethical standards, and to a re-evaluation of the scientific agenda. Such negative results were identified as potentially impacting on funding for trials and engagement activities. Our findings indicate that trial closures may be used constructively to support opportunities for reflection and renewed vigilance in strategies for stakeholder engagement, communicating trial outcomes, and building research literacy among communities; however, these strategies require sustained resources for community engagement and capacity-building. PMID:22360605

  2. Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis.

    Directory of Open Access Journals (Sweden)

    Joseph S Ross

    2009-09-01

    Full Text Available BACKGROUND: ClinicalTrials.gov is a publicly accessible, Internet-based registry of clinical trials managed by the US National Library of Medicine that has the potential to address selective trial publication. Our objectives were to examine completeness of registration within ClinicalTrials.gov and to determine the extent and correlates of selective publication. METHODS AND FINDINGS: We examined reporting of registration information among a cross-section of trials that had been registered at ClinicalTrials.gov after December 31, 1999 and updated as having been completed by June 8, 2007, excluding phase I trials. We then determined publication status among a random 10% subsample by searching MEDLINE using a systematic protocol, after excluding trials completed after December 31, 2005 to allow at least 2 y for publication following completion. Among the full sample of completed trials (n = 7,515, nearly 100% reported all data elements mandated by ClinicalTrials.gov, such as intervention and sponsorship. Optional data element reporting varied, with 53% reporting trial end date, 66% reporting primary outcome, and 87% reporting trial start date. Among the 10% subsample, less than half (311 of 677, 46% of trials were published, among which 96 (31% provided a citation within ClinicalTrials.gov of a publication describing trial results. Trials primarily sponsored by industry (40%, 144 of 357 were less likely to be published when compared with nonindustry/nongovernment sponsored trials (56%, 110 of 198; p<0.001, but there was no significant difference when compared with government sponsored trials (47%, 57 of 122; p = 0.22. Among trials that reported an end date, 75 of 123 (61% completed prior to 2004, 50 of 96 (52% completed during 2004, and 62 of 149 (42% completed during 2005 were published (p = 0.006. CONCLUSIONS: Reporting of optional data elements varied and publication rates among completed trials registered within ClinicalTrials.gov were low

  3. Environmental Implementation Plan

    International Nuclear Information System (INIS)

    The Environmental Implementation Plan (EIP) is a dynamic long-range environmental-protection plan for SRS. The EIP communicates the current and future (five year) environmental plans from individual organizations and divisions as well as site environmental initiatives which are designed to protect the environment and meet or exceed compliance with changing environmental/ regulatory requirements. Communication with all site organizations is essential for making the site environmental planning process work. Demonstrating environmental excellence is a high priority embodied in DOE and WSRC policy. Because of your support and participation in the three EIP initiatives; Reflections, Sectional Revision, and Integrated Planning, improvements are being made to the EIP and SRS environmental protection programs. I appreciate the ''Partnership in Environmental Excellence'' formed by the environmental coordinators and professionals who work daily toward our goal of compliance and environmental excellence. I look forward to seeing continued success and improvement in our environmental protection programs through combined efforts of all site organizations to protect our employees, the public health, and the environment. Together, we will achieve our site vision for SRS to be the recognized model for Environmental Excellence in the DOE Nuclear Weapons Complex

  4. EPA speeds technology implementation

    International Nuclear Information System (INIS)

    Common barriers block the use of innovative remediation technologies. The Innovative Treatment Remediation Demonstration (ITRD) Program at the US Department of Energy's (DOE's) Sandia National Laboratories was initiated in 1993 in cooperation with the US Environmental Protection Agency's (EPA's) Technology Innovation Office in an attempt to reduce these barriers and accelerate the implementation of innovative remediation technologies. The innovative technologies considered for evaluation by the ITRD program lack the cost and performance information that would otherwise permit their full consideration as remedial alternatives. These technologies have often shown promise in pilot-scale applications but have limited full-scale data. Some examples in this category include: bioremediation, in situ dynamic stripping, soil washing and soil flushing, solvent and surfactant extraction and chemical treatment, in situ passive treatment, and advanced physical separation techniques. Currently, three ITRD projects are under way. ITRD sites are generally small, and most are characterized sites already scheduled for remediation. Thus, each project can be initiated quickly; additional program costs are minimized; and overall site remediation is accelerated. ITRD projects tend to target sites with typical soil and groundwater contamination problems. Contaminants at such sites include chlorinated solvents and petroleum products; pesticides, polychlorinated biphenyls (PCBs), and dioxins; heavy metals; explosives; and complex or multiconstituent contamination. The paper describes the activities at these three projects located at Pinellas, Mound Laboratory, and Fernald

  5. TRUPACT-1 implementation plan

    Energy Technology Data Exchange (ETDEWEB)

    Hurley, J.D.; Tappen, J.J. (Westinghouse Electric Corp., Albuquerque, NM (United States). Joint Integration Office); Christensen, D.S. (USDOE Joint Integration Office, Albuquerque, NM (United States)) (eds.)

    1985-09-01

    TRUPACT-1, the TRansUranic PACkage Transporter is a packaging designed to transport defense contact handled transuranic (CH-TRU) waste from generating and interim TRU waste storage facilities to the Waste Isolation Pilot Plant (WIPP). Prior to fabrication and procurement of a full fleet, an initial design (TRUPACT-1) will be introduced to the defense TRU waste complex through use in an operational prototype fleet which will consist of Units 1, 2, and 3. In an effort to provide a relatively smooth introduction of the TRUPACT-1, the TRUPACT Technical Team (TTT) has developed the following implementation plan. The plan provides detailed information on user handling opportunities, schedules, equipment, responsibilities, reporting and data collection activities to be performed. The intent of this document is to provide users of the TRUPACT-1 with a guidance document, complete with references, that will allow the smooth introduction of this new transportation system by providing the information necessary for collecting operational, performance and cost data. These data will be used in modeling and full fleet design and procurement activities. In addition, these data will help fine tune procedures in the inspection and maintenance document and the operational document. Additional objectives of this plan are to aid in the establishment of site operational, inspection and maintenance procedures as well as training of site operators and briefing state and local officials.

  6. Future of fusion implementation

    International Nuclear Information System (INIS)

    For fusion to become available for commercial use in the 21st century, R and D must be undertaken now. But it is hard to justify these expenditures with a cost/benefit oriented assessment methodology, because of both the time-frame and the uncertainty of the future benefits. Focusing on the factors most relevant for current consideration of fusion's commercial prospects, i.e., consumption levels and the outcomes for fission, solar, and coal, many possible futures of the US energy system are posited and analyzed under various assumptions about costs. The Reference Energy System approach was modified to establish both an appropriate degree of detail and explicit time dependence, and a computer code used to organize the relevant data and to perform calculations of system cost (annual and discounted present value), resource use, and residuals that are implied by the consumptions levels and technology mix in each scenario. Not unreasonable scenarios indicate benefits in the form of direct cost savings, which may well exceed R and D costs, which could be attributed to the implementation of fusion

  7. Environmental Implementation Plan

    Energy Technology Data Exchange (ETDEWEB)

    1994-02-01

    The Environmental Implementation Plan (EIP) is a dynamic long-range environmental-protection plan for SRS. The EIP communicates the current and future (five year) environmental plans from individual organizations and divisions as well as site environmental initiatives which are designed to protect the environment and meet or exceed compliance with changing environmental/ regulatory requirements. Communication with all site organizations is essential for making the site environmental planning process work. Demonstrating environmental excellence is a high priority embodied in DOE and WSRC policy. Because of your support and participation in the three EIP initiatives; Reflections, Sectional Revision, and Integrated Planning, improvements are being made to the EIP and SRS environmental protection programs. I appreciate the ``Partnership in Environmental Excellence`` formed by the environmental coordinators and professionals who work daily toward our goal of compliance and environmental excellence. I look forward to seeing continued success and improvement in our environmental protection programs through combined efforts of all site organizations to protect our employees, the public health, and the environment. Together, we will achieve our site vision for SRS to be the recognized model for Environmental Excellence in the DOE Nuclear Weapons Complex.

  8. Traversing the Translational Trail for Trials

    OpenAIRE

    Steeves, John D.; John L. K. Kramer; Zariffa, Jose

    2012-01-01

    The principles of spinal cord injury clinical trial programs are briefly reviewed as one example of the challenge faced by most human studies of neurologically directed therapeutic interventions, including rehabilitation strategies. Different trial protocols are reviewed, as are inclusion/exclusion criteria for study subjects, the choice of clinical endpoints, and the statistical approaches that might be used in a trial program. Potential factors that might confound the accurate interpretatio...

  9. Clinical trials: innovation, progress and controversy

    OpenAIRE

    Martin GS

    2011-01-01

    Greg S MartinDepartment of Pulmonary, Allergy and Critical Care, Emory University, Atlanta, Georgia, USAThe Open Access Journal of Clinical Trials began in 2009 with the goal of being an authoritative, open access source for international, peer-reviewed publications in the field of human research and clinical trials. Since then, the Open Access Journal of Clinical Trials has published approximately 30 high-quality articles on original research, innovative reviews, and critical commentaries. T...

  10. The Clinical Trials Transformation Initiative (CTTI)

    OpenAIRE

    Alberto Grignolo

    2011-01-01

    The Clinical Trials Transformation Initiative (CTTI) is a public-private partnership created in 2007 between the United States Food and Drug Administration (FDA) and Duke University for the purpose of identifying practices that will increase the quality and efficiency of clinical trials. The initiative was generated from the realization that the clinical trials system in the United States has been suffering as a result of increasingly longer study start-up times, slowing enrollment of patient...

  11. Methodological Issues in Negative Symptom Trials

    OpenAIRE

    Marder, Stephen R.; Daniel, David G; Alphs, Larry; Awad, A George; Richard S E Keefe

    2011-01-01

    Individuals from academia, the pharmaceutical industry, and the US Food and Drug Administration used a workshop format to discuss important methodological issues in the design of trials of pharmacological agents for improving negative symptoms in schizophrenia. The issues addressed included the need for a coprimary functional measure for registration trials; the characteristics of individuals who should enter negative symptom trials; the optimal duration for a proof-of-concept or registration...

  12. Strategies and Endpoints of Antifibrotic Drug Trials

    OpenAIRE

    Torok, Natalie; Jonathan A Dranoff; Schuppan, Detlef; Friedman, Scott L.

    2015-01-01

    There is an urgent need to develop antifibrotic therapies for chronic liver disease, and to clarify which endpoints in antifibrotic trials will be acceptable to regulatory agencies. AASLD sponsored an endpoints conference to help accelerate the efficient testing of antifibrotic agents and to develop recommendations on clinical trial design for liver fibrosis. In this review we summarize the salient and novel elements of this conference and provide directions for future clinical trial design. ...

  13. Potential bias in ophthalmic pharmaceutical clinical trials

    OpenAIRE

    Paul Varner

    2008-01-01

    Paul VarnerJohn J Pershing Veterans’ Administration Medical Center, Poplar Bluff, Missouri, USAAbstract: To make clinicians aware of potential sources of error in ophthalmic pharmaceutical clinical trials that can lead to erroneous interpretation of results, a critical review of the study design of various pharmaceutical ophthalmic clinical trials was completed. Discrepancies as a result of study shortcomings may explain observed differences between reported ophthalmic trial data an...

  14. Patient centric approach for clinical trials: Current trend and new opportunities

    Directory of Open Access Journals (Sweden)

    Neha Shankar Sharma

    2015-01-01

    Full Text Available The clinical research industry today is undergoing a major facelift. Companies are continuously looking to adopt and implement effective and innovative ways to accelerate drug launches in the market. Companies today are more open and do not view patients as mere "subjects" who generate data, - but as informed collaborators whose participation is "core" to the overall success of trials leading to the emergence of the concept of "patient-centric trials." This paper is intended to highlight the current trends and new opportunities that can be seen in industry -indicative of crucial role patients today play in their own health care using technology, social media and self education.

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

    International Nuclear Information System (INIS)

    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

  16. Lessons learned in a clinical trial for military sexual trauma-related posttraumatic stress disorder

    Directory of Open Access Journals (Sweden)

    Alina Surís, PhD

    2016-07-01

    Full Text Available A large body of literature exists describing the challenges associated with implementing randomized controlled clinical trials (RCTs [1]. However, when clinical trials are conducted within Department of Veterans Affairs (VA Medical Center (VAMC settings, several additional and unique factors contribute to the difficulty of conducting RCTs. The challenges and strategies to address them, described in this editorial, are based on an RCT conducted to determine the effectiveness of an evidence-based therapy to treat Veterans with military sexual trauma (MST–related posttraumatic stress disorder (PTSD [2].

  17. Feasibility of a Trial on Improvisational Music Therapy for Children with Autism Spectrum Disorder

    DEFF Research Database (Denmark)

    Geretsegger, Monika; Holck, Ulla; Bieleninik, Łucja;

    2016-01-01

    Background: To conduct generalizable, rigorously designed, adequately powered trials investigating music therapy and other complex interventions, it is essential that study procedures are feasible and acceptable for participants. To date, only limited evidence on feasibility of trial designs and...... strategies to facilitate study implementation is available in the music therapy literature. Objective: Using data from a subsample of a multi-center RCT on improvisational music therapy (IMT) for autism spectrum disorder (ASD), this study aims to evaluate feasibility of study procedures, evaluate safety...

  18. Moving towards a University Wide Implementation of an ePortfolio Tool

    Science.gov (United States)

    Lambert, Sarah; Corrin, Linda

    2007-01-01

    The University of Wollongong has been strategically exploring ePortfolios since 2002. Building on lessons learnt from student trials across two different disciplines in 2002/3 and 2006, the project team is on the verge of implementing a university wide ePortfolio tool customisable for all students across all faculties. This paper describes the…

  19. Australian Curriculum Implementation in a Remote Aboriginal School: A Curriculum Leader's Search for a Transformational Compromise

    Science.gov (United States)

    Parkinson, Chloe

    2015-01-01

    This paper examines the trial implementation of the Australian Curriculum in a remote Aboriginal school. It was a school that at the time was beginning to achieve successes with the development of dual-knowledge, transformational outcomes based curriculum that had its justification in the Northern Territory Curriculum Framework. Drawing on the…

  20. Power analysis of trials with multilevel data

    CERN Document Server

    Moerbeek, Mirjam

    2015-01-01

    Power Analysis of Trials with Multilevel Data covers using power and sample size calculations to design trials that involve nested data structures. The book gives a thorough overview of power analysis that details terminology and notation, outlines key concepts of statistical power and power analysis, and explains why they are necessary in trial design. It guides you in performing power calculations with hierarchical data, which enables more effective trial design.The authors are leading experts in the field who recognize that power analysis has attracted attention from applied statisticians i

  1. How Experimental Trial Context Affects Perceptual Categorization

    Directory of Open Access Journals (Sweden)

    Thomas J Palmeri

    2015-02-01

    Full Text Available To understand object categorization, participants are tested in experiments often quite different from how people experience object categories in the real world. Learning and knowledge of categories is measured in discrete experimental trials, those trials may or may not provide feedback, trials appear one after another, after some fixed inter-trial interval, with hundreds of trials in a row, within experimental blocks with some structure dictated by the experimental design. In the real world, outside of certain educational and vocational contexts, opportunities to learn and use categories are intermixed over time with a whole multitude of intervening experiences. It is clear from any elementary understanding of human cognition that sequential effects matter, yet this understanding is often ignored, and categorization trials are often instead treated as independent events, immune to local trial context. In this perspective, we use some of our work to illustrate some of the consequences of the fact that categorization experiments have a particular trial structure. Experimental trial context can affect performance in category learning and categorization experiments in ways that can profoundly affect theoretical conclusions.

  2. Single-Trial Inference on Visual Attention

    DEFF Research Database (Denmark)

    Dyrholm, Mads; Kyllingsbæk, Søren; Vangkilde, Signe Allerup;

    2011-01-01

    In this paper we take a step towards single-trial behavioral modeling within a Theory of Visual Attention (TVA). In selective attention tasks, such as the Partial Report paradigm, the subject is asked to ignore distractors and only report stimuli that belong to the target class. Nothing about a...... Report trial. This result retrodicts a latent attentional state of the subject using the observed response from that particular trial and thus differs from other predictions made with TVA which are based on expected values of observed variables. We show an example of the result in single-trial analysis...

  3. Single-Trial Inference on Visual Attention

    DEFF Research Database (Denmark)

    Dyrholm, Mads; Kyllingsbæk, Søren; Vangkilde, Signe Allerup;

    In this paper we take a step towards single-trial behavioral modeling within a Theory of Visual Attention (TVA). In selective attention tasks, such as the Partial Report paradigm, the subject is asked to ignore distractors and only report stimuli that belong to the target class. Nothing about a...... Report trial. This result retrodicts a latent attentional state of the subject using the observed response from that particular trial and thus differs from other predictions made with TVA which are based on expected values of observed variables. We show an example of the result in single-trial analysis...

  4. Clinical trials with fast neutrons in Europe

    International Nuclear Information System (INIS)

    There is an increasing number of European centres with facilities for fast neutron treatment. To prepare protocols for multi-centre trials and to make treatment results intercomparable, many obstacles have to be overcome. A provision for two dose levels in the neutron treatment arm of a trial could enable the estimation of the local cure rate for an acceptable late complication rate. The considerations on which future trials are based as well as the main characteristics of trials in progress in Europe are reported. (author)

  5. Clinical Informatics Consult Service Positively Affects Some Clinical Decisions in the ICU. A Review of: Mulvaney, Shelagh A., Leonard Bickman, Nunzia B. Giuse, Warren E. Lambert, Nila A. Sathe, and Rebecca N. Jerome." A Randomized Effectiveness Trial of a Clinical Informatics Consult Service: Impact on Evidence-based Decision-making and Knowledge Implementation." Journal of the American Medical Informatics Association 15.2 (2008): 203-11.

    OpenAIRE

    Jennifer Kelson

    2009-01-01

    Objective – To determine whether the provision of synthesized research evidence provided by the Clinical Informatics Consult Service (CICS) affects the clinical decision-making of clinicians working in intensive care units (ICUs).Design – Non-blinded randomized control effectiveness trial.Setting – ICUs in United States-based 658 bed university hospital providing tertiary care for adults and children.Subjects – Clinical staff working within one of four ICUs who submitted a request for clinica...

  6. A controlled trial of value-based insurance design – The MHealthy: Focus on Diabetes (FOD trial

    Directory of Open Access Journals (Sweden)

    Stevenson James G

    2009-04-01

    Full Text Available Abstract Background Diabetes affects over 20 million Americans, resulting in substantial morbidity, mortality, and costs. While medications are the cornerstone of secondary prevention, many evidence-based therapies are underutilized, and patients often cite out-of-pocket costs as the reason. Value-based insurance design (VBID is a 'clinically sensitive' refinement to benefit design which links patient cost-sharing to therapy value; the more clinically beneficial (and valuable a therapy is for a patient, the lower that patient's cost-sharing should be. We describe the design and implementation of MHealthy: Focus on Diabetes (FOD, a prospective, controlled trial of targeted co-payment reductions for high value, underutilized therapies for individuals with diabetes. Methods The FOD trial includes 2,507 employees and dependents with diabetes insured by one large employer. Approximately 81% are enrolled in a single independent-practice association model health maintenance organization. The control group includes 8,637 patients with diabetes covered by other employers and enrolled in the same managed care organization. Both groups received written materials about the importance of adherence to secondary prevention therapies, while only the intervention group received targeted co-payment reductions for glycemic agents, antihypertensives, lipid-lowering agents, antidepressants, and diabetic eye exams. Primary outcomes include medication uptake and adherence. Secondary outcomes include health care utilization and expenditures. An interrupted time series, control group design will allow rigorous assessment of the intervention's impact, while controlling for unrelated temporal trends. Individual patient-level baseline data are presented. Discussion To our knowledge, this is the first prospective controlled trial of co-payment reductions targeted to high-value services for high-risk patients. It will provide important information on feasibility of

  7. Barriers to SCM implementing

    Directory of Open Access Journals (Sweden)

    M.E. Rosli

    2008-12-01

    Full Text Available Purpose: This paper explores the barriers faced by Malaysian manufacturing companies in successfullyimplementing the Supply Chain Management (SCM. The study has highlighted some pertinent factorsperforming the barriers that are most frequently reported by the studied companies. Sixteen companies, fromservice and manufacturing companies were studied over a period of two years to assess their SCM practicesthrough survey and interview processes.Design/methodology/approach: This part discusses the research design and methodological issues upon whichthe research is based. The explanation includes two types of research methods, short survey and follow-upinterviews that were identified as being suitable to achieve the aims of this study, which is to identify the currentproblem of SCM practices within the Malaysian SMEs. Research design is a framework or plan for researchused as a guide in collecting and analysing data.Findings: The results showed that the barriers are depending on the types or group of companies business; suchas either it is an SME or a big company. The barriers inhibiting the practice of SCM can be summarized inthe following factors: partnership with suppliers, limited expertise, management commitment, understanding ofSCM, supported technologies and customer satisfaction. The findings are also compared with the results of asimilar study on SCM in other country.Practical implications: Some suggestions are also offered, which is believed to be a good strategy to the companiesto manage the SCM that will lead to sustainable competitive advantage and hence improve their market share.Originality/value: There are interesting barriers between the companies in Malaysia and other country in therespect of SCM implementation. These findings can be used by both Malaysian and other companies to worktogether or review the SCM strategies that will lead to sustainable competitive advantage and hence improvetheir business performance.

  8. Relational Dynamics in Perception: Impacts on Trial-to-trial Variation

    OpenAIRE

    Shimon Marom

    2011-01-01

    We show that trial-to-trial variability in sensory detection of a weak visual stimulus is dramatically diminished when rather than presenting a fixed stimulus contrast, fluctuations in a subject's judgment are matched by fluctuations in stimulus contrast. This attenuation of fluctuations does not involve a change in the subject's psychometric function. The result is consistent with the interpretation of trial-to-trial variability in this sensory detection task being a high-level meta-cognitiv...

  9. Carbon cost of pragmatic randomised controlled trials: retrospective analysis of sample of trials

    OpenAIRE

    Lyle, Katy; Dent, Louise; Bailey, Sally; Kerridge, Lynn; Roberts, Ian; Milne, Ruairidh

    2009-01-01

    Objective To calculate the global warming potential, in carbon dioxide (CO2) equivalent emissions, from a sample of pragmatic randomised controlled trials. Design Retrospective analysis. Data source Internal data held by NIHR Evaluation, Trials and Studies Coordinating Centre. Studies included All eligible pragmatic randomised controlled trials funded by the NIHR Health Technology Assessment programme during 2002 and 2003. Main outcome measure CO2 equivalents for trial activities calculated w...

  10. Making trials matter: pragmatic and explanatory trials and the problem of applicability

    OpenAIRE

    Treweek Shaun; Zwarenstein Merrick

    2009-01-01

    Abstract Randomised controlled trials are the best research design for decisions about the effect of different interventions but randomisation does not, of itself, promote the applicability of a trial's results to situations other than the precise one in which the trial was done. While methodologists and trialists have rightly paid great attention to internal validity, much less has been given to applicability. This narrative review is aimed at those planning to conduct trials, and those aimi...

  11. Practices, patients and (imperfect data - feasibility of a randomised controlled clinical drug trial in German general practices

    Directory of Open Access Journals (Sweden)

    Hummers-Pradier Eva

    2011-04-01

    Full Text Available Abstract Background Randomised controlled clinical (drug trials supply high quality evidence for therapeutic strategies in primary care. Until now, experience with drug trials in German general practice has been sparse. In 2007/2008, the authors conducted an investigator-initiated, non-commercial, double-blind, randomised controlled pilot trial (HWI-01 to assess the clinical equivalence of ibuprofen and ciprofloxacin in the treatment of uncomplicated urinary tract infection (UTI. Here, we report the feasibility of this trial in German general practices and the implementation of Good Clinical Practice (GCP standards as defined by the International Conference on Harmonisation (ICH in mainly inexperienced general practices. Methods This report is based on the experience of the HWI-01 study conducted in 29 German general practices. Feasibility was defined by 1 successful practice recruitment, 2 sufficient patient recruitment, 3 complete and accurate data collection and 4 appropriate protection of patient safety. Results The final practice recruitment rate was 18%. In these practices, 79 of 195 screened UTI patients were enrolled. Recruitment differed strongly between practices (range 0-12, mean 2.8 patients per practice and was below the recruitment goal of approximately 100 patients. As anticipated, practice nurses became the key figures in the screening und recruitment of patients. Clinical trial demands, in particular for completing symptom questionnaires, documentation of source data and reporting of adverse events, did not agree well with GPs' documentation habits and required support from study nurses. In many cases, GPs and practice staff seemed to be overwhelmed by the amount of information and regulations. No sudden unexpected serious adverse reactions (SUSARs were observed during the trial. Conclusions To enable drug trials in general practice, it is necessary to adapt the setup of clinical research infrastructure to the needs of GPs and

  12. The L'Aquila trial

    Science.gov (United States)

    Amato, Alessandro; Cocco, Massimo; Cultrera, Giovanna; Galadini, Fabrizio; Margheriti, Lucia; Nostro, Concetta; Pantosti, Daniela

    2013-04-01

    The first step of the trial in L'Aquila (Italy) ended with a conviction of a group of seven experts to 6 years of jail and several million euros refund for the families of the people who died during the Mw 6.3 earthquake on April 6, 2009. This verdict has a tremendous impact on the scientific community as well as on the way in which scientists deliver their expert opinions to decision makers and society. In this presentation, we describe the role of scientists in charge of releasing authoritative information concerning earthquakes and seismic hazard and the conditions that led to the verdict, in order to discuss whether this trial represented a prosecution to science, and if errors were made in communicating the risk. Documents, articles and comments about the trial are collected in the web site http://processoaquila.wordpress.com/. We will first summarize what was the knowledge about the seismic hazard of the region and the vulnerability of L'Aquila before the meeting of the National Commission for Forecasting and Predicting Great Risks (CGR) held 6 days before the main shock. The basic point of the accusation is that the CGR suggested that no strong earthquake would have occurred (which of course was never mentioned by any seismologist participating to the meeting). This message would have convinced the victims to stay at home, instead of moving out after the M3.9 and M3.5 earthquakes few hours before the mainshock. We will describe how the available scientific information was passed to the national and local authorities, and in general how the Italian scientific Institution in charge of seismic monitoring and research (INGV), the Civil Protection Department (DPC) and the CGR should interact according to the law. As far as the communication and outreach to the public, the scientific Institutions as INGV have the duty to communicate scientific information. Instead, the risk management and the definition of actions for risk reduction is in charge of Civil

  13. Using process evaluation for program improvement in dose, fidelity and reach: the ACT trial experience

    Directory of Open Access Journals (Sweden)

    Kitzman-Ulrich Heather

    2009-11-01

    Full Text Available Abstract Background The purpose of this study was to demonstrate how formative program process evaluation was used to improve dose and fidelity of implementation, as well as reach of the intervention into the target population, in the "Active by Choice Today" (ACT randomized school-based trial from years 1 to 3 of implementation. Methods The intervention integrated constructs from Self-Determination Theory and Social Cognitive Theory to enhance intrinsic motivation and behavioral skills for increasing long-term physical activity (PA behavior in underserved adolescents (low income, minorities. ACT formative process data were examined at the end of each year to provide timely, corrective feedback to keep the intervention "on track". Results Between years 1 and 2 and years 2 and 3, three significant changes were made to attempt to increase dose and fidelity rates in the program delivery and participant attendance (reach. These changes included expanding the staff training, reformatting the intervention manual, and developing a tracking system for contacting parents of students who were not attending the after-school programs regularly. Process outcomes suggest that these efforts resulted in notable improvements in attendance, dose, and fidelity of intervention implementation from years 1 to 2 and 2 to 3 of the ACT trial. Conclusion Process evaluation methods, particularly implementation monitoring, are useful tools to ensure fidelity in intervention trials and for identifying key best practices for intervention delivery.

  14. Lessons learned from benchmark orthopaedic trials.

    Science.gov (United States)

    Swiontkowski, Marc F; Agel, Julie

    2012-07-18

    Benchmark trials in orthopaedics are designed to address a question of substantial interest to clinicians and patients. They are also designed to have prospective data collection, an adequate sample size, an appropriate duration of follow-up based on the injury or treatment under study, blinded adjudication of the outcome variables, appropriate statistical analyses, and widespread and effective dissemination of the information learned in the trial. There are multiple lessons to be gleaned from these trials: (1) Identifying an engaging and relevant clinical question will make it easier to identify centers that are willing to participate. (2) Individual site leadership, both of the overall project and at the individual site, is critical to the success of any trial. (3) Not every trial needs to have a randomized design; observational trials can provide data that will impact clinical care. (4) Patients should understand the long-term goals of the project when they are enrolled so that they have a sense of the importance of their role in the study. (5) Follow-up rates that are >90% are possible for orthopaedic trials, but effort and money are required to achieve this. (6) Patients who do not agree to be randomized should be enrolled as subjects in a parallel observational design if it is available. (7) Blinded adjudication of the outcome variables is recommended whenever feasible. (8) Partnership with the academic community is mandatory for the success of industry-funded, phase-3 United States Food and Drug Administration trials. (9) Intention-to-treat analysis and as-treated analysis should be reported. Benchmark orthopaedic trials can and will change clinical practice, but detailed planning must occur to ensure that the results are believable and relevant to the orthopaedic community. These trials are time-consuming and expensive, but with the use of careful initial planning and continued oversight during the trial, Level-I evidence will be obtained and will be useful

  15. Rush to judgment: the STI-treatment trials and HIV in sub-Saharan Africa

    Directory of Open Access Journals (Sweden)

    Eileen Stillwaggon

    2015-05-01

    Full Text Available Introduction: The extraordinarily high incidence of HIV in sub-Saharan Africa led to the search for cofactor infections that could explain the high rates of transmission in the region. Genital inflammation and lesions caused by sexually transmitted infections (STIs were a probable mechanism, and numerous observational studies indicated several STI cofactors. Nine out of the ten randomized controlled trials (RCTs, however, failed to demonstrate that treating STIs could lower HIV incidence. We evaluate all 10 trials to determine if their design permits the conclusion, widely believed, that STI treatment is ineffective in reducing HIV incidence. Discussion: Examination of the trials reveals critical methodological problems sufficient to account for statistically insignificant outcomes in nine of the ten trials. Shortcomings of the trials include weak exposure contrast, confounding, non-differential misclassification, contamination and effect modification, all of which consistently bias the results toward the null. In any future STI-HIV trial, ethical considerations will again require weak exposure contrast. The complexity posed by HIV transmission in the genital microbial environment means that any future STI-HIV trial will face confounding, non-differential misclassification and effect modification. As a result, it is unlikely that additional trials would be able to answer the question of whether STI control reduces HIV incidence. Conclusions: Shortcomings in published RCTs render invalid the conclusion that treating STIs and other cofactor infections is ineffective in HIV prevention. Meta-analyses of observational studies conclude that STIs can raise HIV transmission efficiency two- to fourfold. Health policy is always implemented under uncertainty. Given the known benefits of STI control, the irreparable harm from not treating STIs and the likely decline in HIV incidence resulting from STI control, it is appropriate to expand STI control

  16. Psychological distress of cancer and clinical trial participation: a review of the literature.

    Science.gov (United States)

    Kelly, C; Ghazi, F; Caldwell, K

    2002-03-01

    The House of Commons Select Committee on Science and Technology 2000 state that currently less than 5% of adult patients with solid tumours are entered into clinical trials. They recommend that increasing the number of adult cancer patients entering clinical trials must become a high priority. Health-care providers need to prepare themselves for this proposed increase in trial participants by assessing the current status of care and implementing changes within the current infrastructure to provide optimal holistic care. Cancer can change a patient's life either for better or for worse. At one extreme, having cancer leads to enhanced appreciation of life and closer bonds with others. However, at the other extreme, cancer combined with its treatment is viewed as an event that evokes distress and emotional anguish taxing the individual's ability to cope. In the last 25 years, owing to the advent of clinical trials, progress has been made in cancer treatment. Clinical trials may be hailed as the saviour to many therapeutic dilemmas. Treatments are now available which can offer patients hope of cure. Nevertheless, many participants may fear, for the purpose of research, that they may be assigned to less than optimal therapy or that their care will be carried out in a sterile scientific atmosphere devoid of humane and personal consideration. These and other reasons may cause unacceptable personal distress that overrides the potential therapeutic gain. Cancer diagnosis coupled with the ramifications of clinical trial involvement can have significant psychological implications. They may trigger the onset of a mood disorder or exacerbate a present symptom. This article will identify mood disorders in the cancer population, focus on the participants' needs in the clinical trial arena and investigate the influence trial participation has on psychological status. PMID:11966830

  17. SIC 2007: implementation in ONS

    OpenAIRE

    John C Hughes

    2008-01-01

    Summarises the major differences between the current classification, SIC 2003 and SIC 2007 and sets out plans for implementationThe Office for National Statistics (ONS) is currently formalising its plans for the implementation of the United Kingdom Standard Industrial Classification of All Economic Activities 2007 (UK SIC 2007). This article is a summary of the major differences between the current classification, SIC 2003, and SIC 2007, and sets out ONS plans for implementation across a rang...

  18. Verified Cryptographic Implementations for TLS

    OpenAIRE

    Bhargavan, Karthikeyan; Fournet, Cédric; Corin, Ricardo; Zălinescu, Eugen

    2012-01-01

    International audience We intend to narrow the gap between concrete implementations of cryptographic protocols andtheir verified models. We develop and verify a small functional implementation of the TransportLayer Security protocol (TLS 1.0). We make use of the same executable code for interoperabilitytesting against mainstream implementations, for automated symbolic cryptographic verification,and for automated computational cryptographic verification. We rely on a combination of recentto...

  19. Implementing Strassen's Algorithm with BLIS

    OpenAIRE

    Huang, Jianyu; Smith, Tyler M.; Henry, Greg M.; Van de Geijn, Robert A.

    2016-01-01

    We dispel with "street wisdom" regarding the practical implementation of Strassen's algorithm for matrix-matrix multiplication (DGEMM). Conventional wisdom: it is only practical for very large matrices. Our implementation is practical for small matrices. Conventional wisdom: the matrices being multiplied should be relatively square. Our implementation is practical for rank-k updates, where k is relatively small (a shape of importance for libraries like LAPACK). Conventional wisdom: it inheren...

  20. Smart Grid Technologies and Implementations

    OpenAIRE

    Zhang, Haotian

    2014-01-01

    Smart grid has been advocated in both developing and developed countries in many years to deal with large amount of energy deficit and air pollutions. However, many literatures talked about some specific technologies and implementations, few of them could give a clear picture on the smart grid implementations in a macro scale like what is the main consideration for the smart grid implementations, how to examine the power system operation with communication network deployment, how to determine...