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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. 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.

  3. 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

  4. Impact of STROBE Statement Publication on Quality of Observational Study Reporting: Interrupted Time Series versus Before-After Analysis

    NARCIS (Netherlands)

    S. Bastuji-Garin (Sylvie); E. Sbidian (Emilie); C. Gaudy-Marqueste (Caroline); E. Ferrat (Emilie); J.C. Roujeau (Jean-Claude); M.A. Richard (Marie-Aleth); F. Canoui-Poitrine (Florence); J.N. Bouwes Bavinck (Jan Nico); P.J. Coenraads (Pieter-Jan); T.L. Diepgen; P. Elsner (Peter); I. Garcia-Doval (Ignacio); J.J. Grob; S. Langan (Sinead); L. Naldi; T.E.C. Nijsten (Tamar); J. Schmitt (Julien); Å. Svensson (Åke); H. Williams

    2013-01-01

    textabstractBackground:In uncontrolled before-after studies, CONSORT was shown to improve the reporting of randomised trials. Before-after studies ignore underlying secular trends and may overestimate the impact of interventions. Our aim was to assess the impact of the 2007 STROBE statement publicat

  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. Implementing nursing diagnostics effectively: cluster randomized trial.

    NARCIS (Netherlands)

    Müller-Staub, M.; Needham, I.; Odenbreit, M.; Lavin, M.A.; Achterberg, T. van

    2008-01-01

    AIM: This paper is a report of a study to investigate the effect of guided clinical reasoning. This method was chosen as a follow-up educational measure (refresher) after initial implementation of standardized language. BACKGROUND: Research has demonstrated nurses' need for education in diagnostic r

  7. Design and implementation of clinical trials in rehabilitation research.

    Science.gov (United States)

    Hart, Tessa; Bagiella, Emilia

    2012-08-01

    The growth of evidence-based medicine means that both researchers and clinicians must grasp the complex issues involved in implementing clinical trials, which are especially challenging for the behavioral (experience-based) treatments that predominate in rehabilitation. In this article we discuss selected issues germane to the design, implementation, and analysis of group-level clinical trials in rehabilitation. We review strengths, weaknesses, and best applications of 1-sample, between-subjects, and within-subjects study designs, including newer models such as practical clinical trials and point-of-care trials. We also discuss the selection of appropriate control conditions against which to test rehabilitation treatments, as well as issues related to trial blinding. In a section on treatment definition, we discuss the challenges of specifying the active ingredients in the complex interventions that are widely used in rehabilitation, and present an illustration of 1 approach to defining treatments via the learning mechanisms that underlie them. Issues related to treatment implementation are also discussed, including therapist allocation and training, and assessment of treatment fidelity. Finally we consider 2 statistical topics of particular importance to many rehabilitation trials: the use of multiple or composite outcomes, and factors that must be weighed in estimating sample size for clinical trials.

  8. 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. ...

  9. 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

  10. Implementation of the Dutch low back pain guideline for general practitioners: a cluster randomized controlled trial.

    NARCIS (Netherlands)

    Engers, A.J.; Wensing, M.J.P.; Tulder, M.W. van; Timmermans, A.; Oostendorp, R.A.B.; Koes, B.W.; Grol, R.P.T.M.

    2005-01-01

    STUDY DESIGN: Cluster randomized controlled trial for a multifaceted implementation strategy. OBJECTIVES: To assess the effectiveness of tailored interventions (multifaceted implementation strategy) to implement the Dutch low back pain guideline for general practitioners with regard to adherence to

  11. 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.

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

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    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

  13. 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...

  14. 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

  15. 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...

  16. 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...

  17. Is implementing screening for distress an efficient means to recruit patients to a psychological intervention trial?

    NARCIS (Netherlands)

    van Scheppingen, Corinne; Schroevers, Maya J.; Pool, Grieteke; Smink, Ans; Mul, Veronique E.; Coyne, James C.; Sanderman, Robbert

    2014-01-01

    ObjectivesPsychological interventions show greater efficacy when evaluated with distressed patients. We report on the feasibility of implementing screening for recruiting distressed cancer patients to a randomized controlled trial of problem-solving therapy (PST), characteristics associated with enr

  18. 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…

  19. 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.

  20. Impact of STROBE statement publication on quality of observational study reporting: interrupted time series versus before-after analysis.

    Directory of Open Access Journals (Sweden)

    Sylvie Bastuji-Garin

    Full Text Available BACKGROUND: In uncontrolled before-after studies, CONSORT was shown to improve the reporting of randomised trials. Before-after studies ignore underlying secular trends and may overestimate the impact of interventions. Our aim was to assess the impact of the 2007 STROBE statement publication on the quality of observational study reporting, using both uncontrolled before-after analyses and interrupted time series. METHODS: For this quasi-experimental study, original articles reporting cohort, case-control, and cross-sectional studies published between 2004 and 2010 in the four dermatological journals having the highest 5-year impact factors (≥ 4 were selected. We compared the proportions of STROBE items (STROBE score adequately reported in each article during three periods, two pre STROBE period (2004-2005 and 2006-2007 and one post STROBE period (2008-2010. Segmented regression analysis of interrupted time series was also performed. RESULTS: Of the 456 included articles, 187 (41% reported cohort studies, 166 (36.4% cross-sectional studies, and 103 (22.6% case-control studies. The median STROBE score was 57% (range, 18%-98%. Before-after analysis evidenced significant STROBE score increases between the two pre-STROBE periods and between the earliest pre-STROBE period and the post-STROBE period (median score2004-05 48% versus median score2008-10 58%, p<0.001 but not between the immediate pre-STROBE period and the post-STROBE period (median score2006-07 58% versus median score2008-10 58%, p = 0.42. In the pre STROBE period, the six-monthly mean STROBE score increased significantly, by 1.19% per six-month period (absolute increase 95%CI, 0.26% to 2.11%, p = 0.016. By segmented analysis, no significant changes in STROBE score trends occurred (-0.40%; 95%CI, -2.20 to 1.41; p = 0.64 in the post STROBE statement publication. INTERPRETATION: The quality of reports increased over time but was not affected by STROBE. Our findings raise

  1. Protocol for economic evaluation alongside the IMPLEMENT cluster randomised controlled trial

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    McKenzie Joanne E

    2008-02-01

    Full Text Available Abstract Background The recent development and publication of evidence-based clinical practice guidelines (CPGs for acute low back pain (LBP has resulted in evidence-based recommendations that, if implemented, have the potential to improve the quality and safety of care for acute LBP. While a strategy has been specified for dissemination of the CPG for acute LBP in Australia, there is no accompanying plan for active implementation. Evidence regarding the cost-effectiveness of active implementation of CPGs for acute LBP is sparse. The IMPLEMENT study will consider the incremental benefits and costs of progressing beyond development and dissemination to implementation. Methods/design Cost-effectiveness and cost-utility analyses alongside the IMPLEMENT cluster randomised controlled trial (CRCT from a societal perspective to quantify the additional costs (savings and health gains associated with a targeted implementation strategy as compared with access to the CPG via dissemination only. Discussion The protocol provided here registers our intent to conduct an economic evaluation alongside the IMPLEMENT study, facilitates peer-review of proposed methods and provides a transparent statement of planned analyses. Trial registration Australian New Zealand Clinical Trials Registry ACTRN012606000098538

  2. 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 ...

  3. Importance of mixed methods in pragmatic trials and dissemination and implementation research.

    Science.gov (United States)

    Albright, Karen; Gechter, Katherine; Kempe, Allison

    2013-01-01

    With increased attention to the importance of translating research to clinical practice and policy, recent years have seen a proliferation of particular types of research, including pragmatic trials and dissemination and implementation research. Such research seeks to understand how and why interventions function in real-world settings, as opposed to highly controlled settings involving conditions not likely to be repeated outside the research study. Because understanding the context in which interventions are implemented is imperative for effective pragmatic trials and dissemination and implementation research, the use of mixed methods is critical to understanding trial results and the success or failure of implementation efforts. This article discusses a number of dimensions of mixed methods research, utilizing at least one qualitative method and at least one quantitative method, that may be helpful when designing projects or preparing grant proposals. Although the strengths and emphases of qualitative and quantitative approaches differ substantially, methods may be combined in a variety of ways to achieve a deeper level of understanding than can be achieved by one method alone. However, researchers must understand when and how to integrate the data as well as the appropriate order, priority, and purpose of each method. The ability to demonstrate an understanding of the rationale for and benefits of mixed methods research is increasingly important in today's competitive funding environment, and many funding agencies now expect applicants to include mixed methods in proposals. The increasing demand for mixed methods research necessitates broader methodological training and deepened collaboration between medical, clinical, and social scientists. Although a number of challenges to conducting and disseminating mixed methods research remain, the potential for insight generated by such work is substantial.

  4. 76 FR 18226 - Guidance for Industry on Postmarketing Studies and Clinical Trials-Implementation of Section 505...

    Science.gov (United States)

    2011-04-01

    ... Clinical Trials--Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act.'' The... clinical trials for prescription drugs approved under the FD&C Act and biological products approved under... of the new provisions and a description of the types of postmarketing studies and clinical...

  5. 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

    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...... 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...

  6. The implementation and evaluation of cognitive milieu therapy for dual diagnosis inpatients: A pragmatic clinical trial

    DEFF Research Database (Denmark)

    Lykke, Jørn; Oestrich, Irene; Austin, Stephen;

    2010-01-01

    milieu therapy (CMT) among a group of dual diagnosis inpatients. CMT is an integrated treatment for both mental illness and substance abuse based on cognitive behavioral principles and carried out within a supportive inpatient environment. A convenience sample of dual diagnosis inpatients (N = 136......Dual diagnosis is chronic psychiatric condition involving serious mental illness and substance abuse. Experts recommend the integration of treatment for concurrent substance abuse and serious psychiatric problems. The following pragmatic trial examined the implementation and outcomes of cognitive...... reported significant reductions in levels of anxiety and depressive symptoms (p

  7. 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

  8. 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...

  9. Technology transfer for the implementation of a clinical trials network on drug abuse and mental health treatment in Mexico.

    Science.gov (United States)

    Horigian, Viviana E; Marín-Navarrete, Rodrigo A; Verdeja, Rosa E; Alonso, Elizabeth; Perez, María A; Fernández-Mondragón, José; Berlanga, Carlos; Medina-Mora, María Elena; Szapocznik, José

    2015-09-01

    Low- and middle-income countries (LMIC) lack the research infrastructure and capacity to conduct rigorous substance abuse and mental health effectiveness clinical trials to guide clinical practice. A partnership between the Florida Node Alliance of the United States National Drug Abuse Treatment Clinical Trials Network and the National Institute of Psychiatry in Mexico was established in 2011 to improve substance abuse practice in Mexico. The purpose of this partnership was to develop a Mexican national clinical trials network of substance abuse researchers and providers capable of implementing effectiveness randomized clinical trials in community-based settings. A technology transfer model was implemented and ran from 2011-2013. The Florida Node Alliance shared the "know how" for the development of the research infrastructure to implement randomized clinical trials in community programs through core and specific training modules, role-specific coaching, pairings, modeling, monitoring, and feedback. The technology transfer process was bi-directional in nature in that it was informed by feedback on feasibility and cultural appropriateness for the context in which practices were implemented. The Institute, in turn, led the effort to create the national network of researchers and practitioners in Mexico and the implementation of the first trial. A collaborative model of technology transfer was useful in creating a Mexican researcher-provider network that is capable of changing national practice in substance abuse research and treatment. Key considerations for transnational technology transfer are presented.

  10. 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.

  11. The implementation and evaluation of cognitive milieu therapy for dual diagnosis inpatients: A pragmatic clinical trial

    DEFF Research Database (Denmark)

    Lykke, Jørn; Oestrich, I.; Austin, Stephen;

    2010-01-01

    ) was assessed pre- and post-intervention from an inpatient setting where CMT was the mode of treatment. Psychopathology was measured using the Brief Psychiatric Rating Scale and substance abuse measured with the DrugCheck scale, breath/urine samples, and the Severity of Dependence Scale. Functioning......Dual diagnosis is chronic psychiatric condition involving serious mental illness and substance abuse. Experts recommend the integration of treatment for concurrent substance abuse and serious psychiatric problems. The following pragmatic trial examined the implementation and outcomes of cognitive...... milieu therapy (CMT) among a group of dual diagnosis inpatients. CMT is an integrated treatment for both mental illness and substance abuse based on cognitive behavioral principles and carried out within a supportive inpatient environment. A convenience sample of dual diagnosis inpatients (N = 136...

  12. 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

  13. 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.

  14. 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...

  15. 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…

  16. 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

  17. Teacher Implementation of Trial-Based Functional Analysis and Differential Reinforcement of Alternative Behavior for Students with Challenging Behavior

    Science.gov (United States)

    Flynn, Susan D.; Lo, Ya-yu

    2016-01-01

    The purpose of this study was to examine the effects of a training package on three middle school special education teachers' accurate implementation of trial-based functional analysis (TBFA) and differential reinforcement of alternative behavior (DRA) with their students with autism spectrum disorders or emotional and behavioral disorders in the…

  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. "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.

  20. Implementing a complex intervention to support personal recovery: a qualitative study nested within a cluster randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Mary Leamy

    Full Text Available 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. SETTING: 14 community-based mental health teams in two UK sites (one urban, one semi-rural who received the intervention. RESULTS: The factors influencing the implementation of the intervention can be organised under two over-arching themes: Organisational readiness for change and Training effectiveness. Organisational readiness for change comprised three sub-themes: NHS Trust readiness; Team readiness; and Practitioner readiness. Training effectiveness comprised three sub-themes: Engagement strategies; Delivery style and Modelling recovery principles. CONCLUSIONS: Three findings can inform future implementation and evaluation of complex interventions. First, the underlying intervention model predicted that three areas would be important for changing practice: staff skill development; intention to implement; and actual implementation behaviour. This study highlighted the importance of targeting the transition from practitioners' intent to implement to actual implementation behaviour, using experiential learning and target setting. Second, practitioners make inferences about organisational commitment by observing the allocation of resources, Knowledge Performance Indicators and service evaluation outcome measures. These need to be aligned with recovery values, principles and practice. Finally, we recommend the use of organisational readiness tools as an inclusion criteria for selecting both organisations and teams in cluster RCTs. We believe this would

  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. 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...

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

    Directory of Open Access Journals (Sweden)

    Adang Eddy

    2011-03-01

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

  4. Evaluation of hospital palliative care teams: strengths and weaknesses of the before-after study design and strategies to improve it.

    Science.gov (United States)

    Simon, S; Higginson, I J

    2009-01-01

    Hospital palliative care teams (HPCTs) are well established as multi-professional services to provide palliative care in an acute hospital setting and are increasing in number. However, there is still limited evaluation of them, in terms of efficacy and effectiveness. The gold standard method of evaluation is a randomised control trial, but because of methodological (e.g., randomisation), ethical and practical difficulties such trials are often not possible. HPCT is a complex intervention, and the specific situation in palliative care makes it challenging to evaluate (e.g., distress and cognitive impairment of patients). The quasi-experimental before-after study design has the advantage of enabling an experimental character without randomisation. But this has other weaknesses and is prone to bias, for example, temporal trends and selection bias. As for every study design, avoidance and minimisation of bias is important to improve validity. Therefore, strategies of selecting an appropriate control group or time series and applying valid outcomes and measurement tools help reducing bias and strengthen the methods. Special attention is needed to plan and define the design and applied method.

  5. 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)

  6. 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

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

    Science.gov (United States)

    McKenzie, Joanne E; French, Simon D; O'Connor, Denise A; Grimshaw, Jeremy M; Mortimer, Duncan; Michie, Susan; Francis, Jill; Spike, Neil; Schattner, Peter; Kent, Peter M; Buchbinder, Rachelle; Green, Sally E

    2008-01-01

    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 control arm will receive access

  8. 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,…

  9. 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 ...

  10. 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

  11. Design and implementation of a dental caries prevention trial in remote Canadian Aboriginal communities

    Directory of Open Access Journals (Sweden)

    Leroux Brian

    2010-05-01

    Full Text Available Abstract Background The goal of this cluster randomized trial is to test the effectiveness of a counseling approach, Motivational Interviewing, to control dental caries in young Aboriginal children. Motivational Interviewing, a client-centred, directive counseling style, has not yet been evaluated as an approach for promotion of behaviour change in indigenous communities in remote settings. Methods/design Aboriginal women were hired from the 9 communities to recruit expectant and new mothers to the trial, administer questionnaires and deliver the counseling to mothers in the test communities. The goal is for mothers to receive the intervention during pregnancy and at their child's immunization visits. Data on children's dental health status and family dental health practices will be collected when children are 30-months of age. The communities were randomly allocated to test or control group by a random "draw" over community radio. Sample size and power were determined based on an anticipated 20% reduction in caries prevalence. Randomization checks were conducted between groups. Discussion In the 5 test and 4 control communities, 272 of the original target sample size of 309 mothers have been recruited over a two-and-a-half year period. A power calculation using the actual attained sample size showed power to be 79% to detect a treatment effect. If an attrition fraction of 4% per year is maintained, power will remain at 80%. Power will still be > 90% to detect a 25% reduction in caries prevalence. The distribution of most baseline variables was similar for the two randomized groups of mothers. However, despite the random assignment of communities to treatment conditions, group differences exist for stage of pregnancy and prior tooth extractions in the family. Because of the group imbalances on certain variables, control of baseline variables will be done in the analyses of treatment effects. This paper explains the challenges of conducting

  12. 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...

  13. 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)...

  14. 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

  15. 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

  16. Community occupancy before-after-control-impact (CO-BACI) analysis of Hurricane Gudrun on Swedish forest birds.

    Science.gov (United States)

    Russell, James C; Stjernman, Martin; Lindström, Åke; Smith, Henrik G

    2015-04-01

    Resilience of ecological communities to perturbation is important in the face of increased global change from anthropogenic stressors. Monitoring is required to detect the impact of, and recovery from, perturbations, and before-after-control-impact (BACI) analysis provides a powerful framework in this regard. However, species in a community are not observed with perfect detection, and occupancy analysis is required to correct for imperfect detectability of species. We present a Bayesian community occupancy before-after-control-impact (CO-BACI) framework to monitor ecological community response to perturbation when constituent species are imperfectly detected. We test the power of the model to detect changes in community composition following an acute perturbation with simulation. We then apply the model to a study of the impact of a large hurricane on the forest bird community of Sweden, using data from the national bird survey scheme. Although simulation shows the model can detect changes in community occupancy following an acute perturbation, application to a Swedish forest bird community following a major hurricane detected no change in community occupancy despite widespread forest loss. Birds with landscape occupancy less than 50% required correcting for detectability. We conclude that CO-BACI analysis is a useful tool that can incorporate rare species in analyses and detect occupancy changes in ecological communities following perturbation, but, because it does not include abundance, some impacts may be overlooked.

  17. Community occupancy before-after-control-impact (CO-BACI) analysis of Hurricane Gudrun on Swedish forest birds.

    Science.gov (United States)

    Russell, James C; Stjernman, Martin; Lindström, Åke; Smith, Henrik G

    2015-04-01

    Resilience of ecological communities to perturbation is important in the face of increased global change from anthropogenic stressors. Monitoring is required to detect the impact of, and recovery from, perturbations, and before-after-control-impact (BACI) analysis provides a powerful framework in this regard. However, species in a community are not observed with perfect detection, and occupancy analysis is required to correct for imperfect detectability of species. We present a Bayesian community occupancy before-after-control-impact (CO-BACI) framework to monitor ecological community response to perturbation when constituent species are imperfectly detected. We test the power of the model to detect changes in community composition following an acute perturbation with simulation. We then apply the model to a study of the impact of a large hurricane on the forest bird community of Sweden, using data from the national bird survey scheme. Although simulation shows the model can detect changes in community occupancy following an acute perturbation, application to a Swedish forest bird community following a major hurricane detected no change in community occupancy despite widespread forest loss. Birds with landscape occupancy less than 50% required correcting for detectability. We conclude that CO-BACI analysis is a useful tool that can incorporate rare species in analyses and detect occupancy changes in ecological communities following perturbation, but, because it does not include abundance, some impacts may be overlooked. PMID:26214914

  18. 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.

  19. 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.

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

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    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

  1. Lobster and cod benefit from small-scale northern marine protected areas: inference from an empirical before-after control-impact study.

    Science.gov (United States)

    Moland, Even; Olsen, Esben Moland; Knutsen, Halvor; Garrigou, Pauline; Espeland, Sigurd Heiberg; Kleiven, Alf Ring; André, Carl; Knutsen, Jan Atle

    2013-03-01

    Marine protected areas (MPAs) are increasingly implemented as tools to conserve and manage fisheries and target species. Because there are opportunity costs to conservation, there is a need for science-based assessment of MPAs. Here, we present one of the northernmost documentations of MPA effects to date, demonstrated by a replicated before-after control-impact (BACI) approach. In 2006, MPAs were implemented along the Norwegian Skagerrak coast offering complete protection to shellfish and partial protection to fish. By 2010, European lobster (Homarus gammarus) catch-per-unit-effort (CPUE) had increased by 245 per cent in MPAs, whereas CPUE in control areas had increased by 87 per cent. Mean size of lobsters increased by 13 per cent in MPAs, whereas increase in control areas was negligible. Furthermore, MPA-responses and population development in control areas varied significantly among regions. This illustrates the importance of a replicated BACI design for reaching robust conclusions and management decisions. Partial protection of Atlantic cod (Gadus morhua) was followed by an increase in population density and body size compared with control areas. By 2010, MPA cod were on average 5 cm longer than in any of the control areas. MPAs can be useful management tools in rebuilding and conserving portions of depleted lobster populations in northern temperate waters, and even for a mobile temperate fish species such as the Atlantic cod. PMID:23303544

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

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    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

  3. 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…

  4. Randomized Controlled Trial of Education and Feedback for Implementation of Guidelines for Acute Low Back Pain

    Science.gov (United States)

    Schectman, Joel M; Schroth, W Scott; Verme, Dante; Voss, John D

    2003-01-01

    OBJECTIVE The effect of clinical guidelines on resource utilization for complex conditions with substantial barriers to clinician behavior change has not been well studied. We report the impact of a multifaceted guideline implementation intervention on primary care clinician utilization of radiologic and specialty services for the care of acute low back pain. DESIGN Physician groups were randomized to receive guideline education and individual feedback, supporting patient education materials, both, or neither. The impact on guideline adherence and resource utilization was evaluated during the 12-month period before and after implementation. PARTICIPANTS Fourteen physician groups with 120 primary care physician and associate practitioners from 2 group model HMO practices. INTERVENTIONS Guideline implementation utilized an education/audit/feedback model with local peer opinion leaders. The patient education component included written and videotaped materials on the care of low back pain. MAIN RESULTS The clinician intervention was associated with an absolute increase in guideline-consistent behavior of 5.4% in the intervention group versus a decline of 2.7% in the control group (P = .04). The patient education intervention produced no significant change in guideline-consistent behavior, but was poorly adopted. Patient characteristics including duration of pain, prior history of low back pain, and number of visits during the illness episode were strong predictors of service utilization and guideline-consistent behavior. CONCLUSIONS Implementation of an education and feedback-supported acute low back pain care guideline for primary care clinicians was associated with an increase in guideline-consistent behavior. Patient education materials did not enhance guideline effectiveness. Implementation barriers could limit the utility of this approach in usual care setttings. PMID:14521638

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

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    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

  6. Implementing referral guidelines: lessons from a negative outcome cluster randomised factorial trial in general practice

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    Shaw Lindsey

    2006-11-01

    Full Text Available Abstract Background Few patients with lower bowel symptoms who consult their general practitioner need a specialist opinion. However data from referred patients suggest that those who are referred would benefit from detailed assessment before referral. Methods A cluster randomised factorial trial. 44 general practices in North Trent, UK. Practices were offered either an electronic interactive referral pro forma, an educational outreach visit by a local colorectal surgeon, both or neither. The main outcome measure was the proportion of cases with severe diverticular disease, cancer or precancerous lesions and inflammatory bowel disease in those referred by each group. A secondary outcome was a referral letter quality score. Semi-structured interviews were conducted to identify key themes relating to the use of the software Results From 150 invitations, 44 practices were recruited with a total list size of 265,707. There were 716 consecutive referrals recorded over a six-month period, for which a diagnosis was available for 514. In the combined software arms 14% (37/261 had significant pathology, compared with 19% (49/253 in the non-software arms, relative risk 0.73 (95% CI: 0.46 to 1.15. In the combined educational outreach arms 15% (38/258 had significant pathology compared with 19% (48/256 in the non-educational arms, relative risk 0.79 (95% CI: 0.50 to 1.24. Pro forma practices documented better assessment of patients at referral. Conclusion There was a lack of evidence that either intervention increased the proportion of patients with organic pathology among those referred. The interactive software did improve the amount of information relayed in referral letters although we were unable to confirm if this made a significant difference to patients or their health care providers. The potential value of either intervention may have been diminished by their limited uptake within the context of a cluster randomised clinical trial. A number of

  7. The Collaborative Lithium Trials (CoLT: specific aims, methods, and implementation

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    Hooper Stephen R

    2008-08-01

    Full Text Available Abstract Background Lithium is a benchmark treatment for bipolar illness in adults. However, there has been relatively little methodologically stringent research regarding the use of lithium in youth suffering from bipolarity. Methods Under the auspices of the Best Pharmaceuticals for Children Act (BPCA, a Written Request (WR pertaining to the study of lithium in pediatric mania was issued by the United States Food and Drug Administration (FDA to the National Institute of Child Health and Human Development (NICHD in 2004. Accordingly, the NICHD issued a Request for Proposals (RFP soliciting submissions to pursue this research. Subsequently, the NICHD awarded a contract to a group of investigators in order to conduct these studies. Results The Collaborative Lithium Trials (CoLT investigators, the BPCA-Coordinating Center, and the NICHD developed protocols to provide data that will: (1 establish evidence-based dosing strategies for lithium; (2 characterize the pharmacokinetics and biodisposition of lithium; (3 examine the acute efficacy of lithium in pediatric bipolarity; (4 investigate the long-term effectiveness of lithium treatment; and (5 characterize the short- and long-term safety of lithium. By undertaking two multi-phase trials rather than multiple single-phase studies (as was described in the WR, the feasibility of the research to be undertaken was enhanced while ensuring all the data outlined in the WR would be obtained. The first study consists of: (1 an 8-week open-label, randomized, escalating dose Pharmacokinetic Phase; (2 a 16-week Long-Term Effectiveness Phase; (3 a 28-week double-blind Discontinuation Phase; and (4 an 8-week open-label Restabilization Phase. The second study consists of: (1 an 8-week, double-blind, parallel-group, placebo-controlled Efficacy Phase; (2 an open-label Long-Term Effectiveness lasting either 16 or 24 weeks (depending upon blinded treatment assignment during the Efficacy Phase; (3 a 28-week double

  8. 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...

  9. 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...

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

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    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

  11. How well are the ASAS/OMERACT Core Outcome Sets for Ankylosing Spondylitis implemented in randomized clinical trials? A systematic literature review.

    Science.gov (United States)

    Bautista-Molano, Wilson; Navarro-Compán, Victoria; Landewé, Robert B M; Boers, Maarten; Kirkham, Jamie J; van der Heijde, Désirée

    2014-09-01

    This study aims to investigate how well the Assessment of SpondyloArthritis international Society (ASAS)/Outcome Measures in Rheumatology Clinical Trials (OMERACT) core set and response criteria for ankylosing spondylitis (AS) have been implemented in randomized controlled trials (RCTs) testing pharmacological and non-pharmacological interventions. A systematic literature search was performed up to June 2013 looking for RCTs in patients with axial spondyloarthritis (SpA) (AS and non-radiographic axial SpA). The assessed domains and instruments belonging to the core sets for disease-controlling anti-rheumatic therapy (DC-ART) and symptom-modifying anti-rheumatic drugs (SMARDs) were extracted. Results were reported separately for those trials published until 2 years after the publication of the core set (1 April 2001; 'control trials') and those trials published at least 2 years after the publication date ('implementation trials'). One hundred twenty-three articles from 99 RCTs were included in the analysis, comparing 48 'control trials' and 51 'implementation trials'. Regarding DC-ART core set, the following domains were significantly more frequently assessed in the 'implementation group' in comparison to the 'control group': 'physical function' (100 vs 41.7 %; p ≤ 0.001), 'peripheral joints/entheses' (100 vs 33.3 %; p ≤ 0.001) and 'fatigue' (100 vs 0 %; p ≤ 0.001). Three instruments were significantly more used in the 'implementation group': Bath Ankylosing Spondylitis Functional Index (BASFI) (100 vs 8.3 %; p = ≤ 0.001), CRP (92.3 vs 58.3 %; p = 0.01) and Bath Ankylosing Spondylitis Metrology Index (BASMI) (53.8 vs 0 %; p = 0.001). Regarding SMARD core set domains, physical function (92 vs 23 %; p ≤ 0.001) and fatigue (84 vs 17 %; p ≤ 0.001), as well as the instruments BASFI (88 vs 14 %; p ≤ 0.001) and BASMI (52 vs 0 %; p ≤ 0.001), increased significantly in the 'implementation group'. Twenty per cent of

  12. A randomized clinical trial of home-based telepsychiatric outpatient care via videoconferencing: design, methodology, and implementation

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    Ines Hungerbuehler

    2015-06-01

    Full Text Available Background Healthcare providers are continuously challenged to find innovative, cost-effective alternatives and to scale up existent services to meet the growing demand upon mental health care delivery. Due to continuous advances in technologies, telepsychiatry has become an effective tool for psychiatric care. In 2012, the Institute of Psychiatry of the University of São Paulo Medical School started a randomized clinical trial of home-based telepsychiatric outpatient care via videoconferencing. Objective The objective of this article is to describe the design, methodology and implementation of a pilot project, which aimed to verify the applicability and efficiency of psychiatric attendance via Internet-based videoconferencing in a resource-constrained environment. Methods The project consisted of a 12 months follow-up study with a randomized clinical trial, which compared various quality indicators between home-based telepsychiatric aftercare via videoconferencing and face-to-face aftercare. Results The final sample comprised 107 outpatients (53 in the telepsychiatry group and 54 in the control group. Among 1,227 realized consultations, 489 were held by videoconferencing. Satisfaction with the aftercare by videoconferencing and the medication delivery was high among patients. Attending psychiatrists were satisfied with the assistance by videoconferencing. Discussion The experiences during this pilot project have overall been very positive and psychiatric outpatient care by videoconferencing seems viable to treat patients even in a resource-constrained environment.

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

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    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

  14. What work has to be done to implement collaborative care for depression? Process evaluation of a trial utilizing the Normalization Process Model

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    Lankshear Annette J

    2010-02-01

    Full Text Available Abstract Background There is a considerable evidence base for 'collaborative care' as a method to improve quality of care for depression, but an acknowledged gap between efficacy and implementation. This study utilises the Normalisation Process Model (NPM to inform the process of implementation of collaborative care in both a future full-scale trial, and the wider health economy. Methods Application of the NPM to qualitative data collected in both focus groups and one-to-one interviews before and after an exploratory randomised controlled trial of a collaborative model of care for depression. Results Findings are presented as they relate to the four factors of the NPM (interactional workability, relational integration, skill-set workability, and contextual integration and a number of necessary tasks are identified. Using the model, it was possible to observe that predictions about necessary work to implement collaborative care that could be made from analysis of the pre-trial data relating to the four different factors of the NPM were indeed borne out in the post-trial data. However, additional insights were gained from the post-trial interview participants who, unlike those interviewed before the trial, had direct experience of a novel intervention. The professional freedom enjoyed by more senior mental health workers may work both for and against normalisation of collaborative care as those who wish to adopt new ways of working have the freedom to change their practice but are not obliged to do so. Conclusions The NPM provides a useful structure for both guiding and analysing the process by which an intervention is optimized for testing in a larger scale trial or for subsequent full-scale implementation.

  15. 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

  16. 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

  17. 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…

  18. 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

  19. 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…

  20. 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

  1. 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.

  2. 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...

  3. Hepatitis C infection among injecting drug users in general practice: a cluster randomised controlled trial of clinical guidelines' implementation

    Science.gov (United States)

    Cullen, Walter; Stanley, June; Langton, Deirdre; Kelly, Yvonne; Staines, Anthony; Bury, Gerard

    2006-01-01

    Background Hepatitis C is a common infection among injecting drug users and has important implications for general practice. Although several clinical guidelines concerning the infection have been published, their effectiveness has yet to be tested. Aim To assess the effectiveness of a general practice-based complex intervention to support the implementation of clinical guidelines for hepatitis C management among current or former drug users attending general practice. Design of study Cluster randomised controlled trial. Setting General practices in the Eastern Regional Health Authority area of Ireland. Method Twenty-six practices were randomly allocated within strata to receive the intervention under study or to provide care as usual for a period of 6 months. There was screening for patients attending general practice for methadone maintenance treatment for hepatitis C and referral of anti-HCV antibody positive patients to a specialist hepatology department for assessment. Results At study completion, patients in the intervention group were significantly more likely to have been screened for hepatitis C than those in the control group, odds ratio adjusted for clustering 3.76 (95% confidence interval [CI] = 1.3 to 11.3) and this association remained significant after adjusting for other potentially confounding variables, using multiple logistic regression, with the odds ratio adjusted for clustering 4.53 (95% CI = 1.39 to 14.78). Although anti-HCV antibody positive patients in the intervention group were more likely to have been referred to a hepatology clinic, this was not statistically significant (P = 0.06). Conclusion General practice has an important role in the care of people at risk of hepatitis C and when appropriately supported can effectively implement current best practice. PMID:17132352

  4. 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...

  5. Geostatistical evaluation of integrated marsh management impact on mosquito vectors using before-after-control-impact (BACI design

    Directory of Open Access Journals (Sweden)

    Dempsey Mary E

    2009-06-01

    Full Text Available Abstract Background In many parts of the world, salt marshes play a key ecological role as the interface between the marine and the terrestrial environments. Salt marshes are also exceedingly important for public health as larval habitat for mosquitoes that are vectors of disease and significant biting pests. Although grid ditching and pesticides have been effective in salt marsh mosquito control, marsh degradation and other environmental considerations compel a different approach. Targeted habitat modification and biological control methods known as Open Marsh Water Management (OMWM had been proposed as a viable alternative to marsh-wide physical alterations and chemical control. However, traditional larval sampling techniques may not adequately assess the impacts of marsh management on mosquito larvae. To assess the effectiveness of integrated OMWM and marsh restoration techniques for mosquito control, we analyzed the results of a 5-year OMWM/marsh restoration project to determine changes in mosquito larval production using GIS and geostatistical methods. Methods The following parameters were evaluated using "Before-After-Control-Impact" (BACI design: frequency and geographic extent of larval production, intensity of larval production, changes in larval habitat, and number of larvicide applications. The analyses were performed using Moran's I, Getis-Ord, and Spatial Scan statistics on aggregated before and after data as well as data collected over time. This allowed comparison of control and treatment areas to identify changes attributable to the OMWM/marsh restoration modifications. Results The frequency of finding mosquito larvae in the treatment areas was reduced by 70% resulting in a loss of spatial larval clusters compared to those found in the control areas. This effect was observed directly following OMWM treatment and remained significant throughout the study period. The greatly reduced frequency of finding larvae in the treatment

  6. 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

  7. 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

  8. 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

  9. How has the economic downturn affected communities and implementation of science-based prevention in the randomized trial of communities that care?

    Science.gov (United States)

    Kuklinski, Margaret R; Hawkins, J David; Plotnick, Robert D; Abbott, Robert D; Reid, Carolina K

    2013-06-01

    This study examined implications of the economic downturn that began in December 2007 for the Community Youth Development Study (CYDS), a longitudinal randomized controlled trial of the Communities That Care (CTC) prevention system. The downturn had the potential to affect the internal validity of the CYDS research design and implementation of science-based prevention in study communities. We used archival economic indicators and community key leader reports of economic conditions to assess the extent of the economic downturn in CYDS communities and potential internal validity threats. We also examined whether stronger economic downturn effects were associated with a decline in science-based prevention implementation. Economic indicators suggested the downturn affected CYDS communities to different degrees. We found no evidence of systematic differences in downturn effects in CTC compared to control communities that would threaten internal validity of the randomized trial. The Community Economic Problems scale was a reliable measure of community economic conditions, and it showed criterion validity in relation to several objective economic indicators. CTC coalitions continued to implement science-based prevention to a significantly greater degree than control coalitions 2 years after the downturn began. However, CTC implementation levels declined to some extent as unemployment, the percentage of students qualifying for free lunch, and community economic problems worsened. Control coalition implementation levels were not related to economic conditions before or after the downturn, but mean implementation levels of science-based prevention were also relatively low in both periods.

  10. 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

  11. Implementation of AF-CBT by community practitioners serving child welfare and mental health: a randomized trial.

    Science.gov (United States)

    Kolko, David J; Baumann, Barbara L; Herschell, Amy D; Hart, Jonathan A; Holden, Elizabeth A; Wisniewski, Stephen R

    2012-02-01

    The Partnerships for Families project is a randomized clinical trial designed to evaluate the implementation of Alternatives for Families: A Cognitive-Behavioral Therapy (AF-CBT), an evidence-based treatment for family conflict, coercion, and aggression, including child physical abuse. To evaluate the effectiveness of a training program in this model, 182 community practitioners from 10 agencies were randomized to receive AF-CBT training (n = 90) using a learning community model (workshops, consultation visits) or Training as Usual (TAU; n = 92) which provided trainings per agency routine. Practitioners completed self-report measures at four time points (0, 6, 12, and 18 months following baseline). Of those assigned to AF-CBT, 89% participated in at least one training activity and 68% met a "training completion" definition. A total of 80 (44%) practitioners were still active clinicians in the study by 18-month assessment in that they had not met our staff turnover or study withdrawal criteria. Using an intent-to-train design, hierarchical linear modeling analyses revealed significantly greater initial improvements for those in the AF-CBT training condition (vs. TAU condition) in CBT-related knowledge and use of AF-CBT teaching processes, abuse-specific skills, and general psychological skills. In addition, practitioners in both groups reported significantly more negative perceptions of organizational climate through the intervention phase. These significant, albeit modest, findings are discussed in the context of treatment training, research, and work force issues as they relate to the diverse backgrounds, settings, and populations served by community practitioners.

  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. 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.

  14. 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...

  15. 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. ...

  16. 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

  17. 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.

  18. 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.

  19. Guiding the design and selection of interventions to influence the implementation of evidence-based practice: an experimental simulation of a complex intervention trial.

    Science.gov (United States)

    Bonetti, Debbie; Eccles, Martin; Johnston, Marie; Steen, Nick; Grimshaw, Jeremy; Baker, Rachel; Walker, Anne; Pitts, Nigel

    2005-05-01

    A consistent finding in health services research is the report of uneven uptake of research findings. Implementation trials have a variable record of success in effectively influencing clinicians' behaviour. A more systematic approach may be to conduct Intervention Modelling Experiments before service-level trials, examining intervention effects on 'interim endpoints' representing clinical behaviour, derived from empirically supported psychological theories. The objectives were to: (1) Design Intervention Modelling Experiments by backward engineering a 'real-world' randomised controlled trial (NEXUS); (2) examine the applicability of psychological theories to clinical decision-making; (3) explore whether psychological theories can illuminate how interventions achieve their effects. A 2 x 2 factorial randomised controlled trial was designed with pre- and post-intervention data collection by postal questionnaire surveys. The first survey was used to generate feedback data and the interventions were delivered in the second survey. General medical practitioners (GPs) in England and Scotland participated. First survey respondents were randomised twice to receive or not audit and feedback and educational reminder messages. The main outcome measures included behavioural intention (general plan to refer for lumbar X-rays) and simulated behaviour (specific, scenario-based, decisions to refer for lumbar X-ray). Predictors were attitude, subjective norm, perceived behavioural control (theory of planned behaviour), self-efficacy (social cognitive theory) and decision difficulty. Both interventions significantly influenced simulated behaviour, but neither influenced behavioural intention. There were no interaction effects. All theoretically derived cognitions significantly predicted simulated behaviour. Only subjective norm was not predictive of behavioural intention. The effect of audit and feedback on simulated behaviour was mediated through perceived behavioural control. The

  20. 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

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

    OpenAIRE

    Francis Jill; Michie Susan; Mortimer Duncan; Grimshaw Jeremy M; O'Connor Denise A; French Simon D; McKenzie Joanne E; Spike Neil; Schattner Peter; Kent Peter M; Buchbinder Rachelle; Green Sally E

    2008-01-01

    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...

  2. IgM-Enriched Immunoglobulin Attenuates Systemic Endotoxin Activity in Early Severe Sepsis: A Before-After Cohort Study

    Science.gov (United States)

    Kirbach, Christin; Warszawska, Joanna; Meybohm, Patrick; Zacharowski, Kai; Koch, Alexander

    2016-01-01

    attenuates the EA levels in patients with severe sepsis and might have an effect on septic thrombocytopenia and fibrinogen depletion. Viscoelastic, aggregometric or inflammatory parameters were not influenced. Trial Registration clinicaltrials.gov NCT02444871 PMID:27504630

  3. Implementation of clinical guidelines on physical therapy for patients with low back pain: randomized trial comparing patient outcomes after a standard and active implementation strategy.

    NARCIS (Netherlands)

    Bekkering, G.E.; Tulder, M.W. van; Hendriks, E.J.M.; Koopmanschap, M.A.; Knol, D.L.; Bouter, L.M.; Oostendorp, R.A.B.

    2005-01-01

    BACKGROUND AND PURPOSE: An active strategy was developed for the implementation of the clinical guidelines on physical therapy for patients with low back pain. The effect of this strategy on patients' physical functioning, coping strategy, and beliefs regarding their low back pain was studied. SUBJE

  4. 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

  5. Taking the bull by the horns: Ethical considerations in the design and implementation of an Ebola virus therapy trial.

    Science.gov (United States)

    Kombe, Francis; Folayan, Morenike O; Ambe, Jennyfer; Igonoh, Adaora; Abayomi, Akin

    2016-01-01

    Ebola virus is categorized as one of the most dangerous pathogens in the world. Although there is no known cure for Ebola virus, there is some evidence that the severity of the disease can be curtailed using plasma from survivors. Although there is a general consensus on the importance of research, methodological and ethical challenges for conducting research in an emergency situation have been identified. Performing clinical trials is important, especially for health conditions that are of public health significance (including rare epidemics) to develop new therapies as well as to test the efficacy and effectiveness of new interventions. However, routine clinical trial procedures can be difficult to apply in emergency public health crises hence require a consideration of alternative approaches on how therapies in these situations are tested and brought to the market. This paper examines some of the ethical issues that arise when conducting clinical trials during a highly dangerous pathogen outbreak, with a special focus on the Ebola virus outbreak in West Africa. The issues presented here come from a review of a protocol that was submitted to the Global Emerging Pathogens Treatment Consortium (GET). In reviewing the proposal, which was about conducting a clinical trial to evaluate the safety and efficacy of using convalescent plasma in the management of Ebola virus disease, the authors deliberated on various issues, which were documented as minutes and later used as a basis for this paper. The experiences and reflections shared by the authors, who came from different regions and disciplines across Africa, present wide-ranging perspectives on the conduct of clinical trials during a dangerous disease outbreak in a resource-poor setting. PMID:26653137

  6. 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

  7. 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…

  8. 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

  9. Evaluation of a theory-informed implementation intervention for the management of acute low back pain in general medical practice: the IMPLEMENT cluster randomised trial.

    Directory of Open Access Journals (Sweden)

    Simon D French

    Full Text Available INTRODUCTION: This cluster randomised trial evaluated an intervention to decrease x-ray referrals and increase giving advice to stay active for people with acute low back pain (LBP in general practice. METHODS: General practices were randomised to either access to a guideline for acute LBP (control or facilitated interactive workshops (intervention. We measured behavioural predictors (e.g. knowledge, attitudes and intentions and fear avoidance beliefs. We were unable to recruit sufficient patients to measure our original primary outcomes so we introduced other outcomes measured at the general practitioner (GP level: behavioural simulation (clinical decision about vignettes and rates of x-ray and CT-scan (medical administrative data. All those not involved in the delivery of the intervention were blinded to allocation. RESULTS: 47 practices (53 GPs were randomised to the control and 45 practices (59 GPs to the intervention. The number of GPs available for analysis at 12 months varied by outcome due to missing confounder information; a minimum of 38 GPs were available from the intervention group, and a minimum of 40 GPs from the control group. For the behavioural constructs, although effect estimates were small, the intervention group GPs had greater intention of practising consistent with the guideline for the clinical behaviour of x-ray referral. For behavioural simulation, intervention group GPs were more likely to adhere to guideline recommendations about x-ray (OR 1.76, 95%CI 1.01, 3.05 and more likely to give advice to stay active (OR 4.49, 95%CI 1.90 to 10.60. Imaging referral was not statistically significantly different between groups and the potential importance of effects was unclear; rate ratio 0.87 (95%CI 0.68, 1.10 for x-ray or CT-scan. CONCLUSIONS: The intervention led to small changes in GP intention to practice in a manner that is consistent with an evidence-based guideline, but it did not result in statistically significant

  10. 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...

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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...

  18. 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.

  19. 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...... 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....... 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...

  20. 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

  1. A multifaceted intervention to implement guidelines and improve admission paediatric care in Kenyan district hospitals: a cluster randomised trial.

    Directory of Open Access Journals (Sweden)

    Philip Ayieko

    2011-04-01

    Full Text Available BACKGROUND: In developing countries referral of severely ill children from primary care to district hospitals is common, but hospital care is often of poor quality. However, strategies to change multiple paediatric care practices in rural hospitals have rarely been evaluated. METHODS AND FINDINGS: This cluster randomized trial was conducted in eight rural Kenyan district hospitals, four of which were randomly assigned to a full intervention aimed at improving quality of clinical care (evidence-based guidelines, training, job aides, local facilitation, supervision, and face-to-face feedback; n  =  4 and the remaining four to control intervention (guidelines, didactic training, job aides, and written feedback; n  =  4. Prespecified structure, process, and outcome indicators were measured at baseline and during three and five 6-monthly surveys in control and intervention hospitals, respectively. Primary outcomes were process of care measures, assessed at 18 months postbaseline. In both groups performance improved from baseline. Completion of admission assessment tasks was higher in intervention sites at 18 months (mean  =  0.94 versus 0.65, adjusted difference 0.54 [95% confidence interval 0.05-0.29]. Uptake of guideline recommended therapeutic practices was also higher within intervention hospitals: adoption of once daily gentamicin (89.2% versus 74.4%; 17.1% [8.04%-26.1%]; loading dose quinine (91.9% versus 66.7%, 26.3% [-3.66% to 56.3%]; and adequate prescriptions of intravenous fluids for severe dehydration (67.2% versus 40.6%; 29.9% [10.9%-48.9%]. The proportion of children receiving inappropriate doses of drugs in intervention hospitals was lower (quinine dose >40 mg/kg/day; 1.0% versus 7.5%; -6.5% [-12.9% to 0.20%], and inadequate gentamicin dose (2.2% versus 9.0%; -6.8% [-11.9% to -1.6%]. CONCLUSIONS: Specific efforts are needed to improve hospital care in developing countries. A full, multifaceted intervention was associated

  2. Impact on Patients' Treatment Outcomes of XpertMTB/RIF Implementation for the Diagnosis of Tuberculosis: Follow-Up of a Stepped-Wedge Randomized Clinical Trial.

    Directory of Open Access Journals (Sweden)

    Anete Trajman

    Full Text Available The impact on treatment outcomes of XpertMTB/RIF, a molecular-based test that provides rapid diagnosis of tuberculosis (TB and rifampicin resistance with high accuracy, has not been reported despite its adoption in a few countries. We here report treatment outcomes in a step-wedged cluster randomized trial for patients diagnosed with XpertMTB/RIF compared to patients diagnosed with sputum smear examination in public health facilities in Brazil.Treatment outcome data were added to the trial database of patients diagnosed from 4 February to 4 October 2012, and crosschecked with data from the national mortality and the drug-resistant TB registers. Treatment outcomes in the intervention (n=2232 and baseline (n=1856 arms were compared using a multilevel regression model.Unfavourable outcomes were frequent in both arms, mainly due to loss to follow-up (16%. Overall unfavourable outcomes were not reduced in the intervention arm (29.6% versus 31.7%, OR=0.93; 95%CI=0.79-1.08. However, the overall TB-attributed death rate was lower in the intervention arm (2.3% vs. 3.8%. Adjusted for HIV status, age group and city, the intervention resulted in a 35% decrease in TB-attributed deaths (OR=0.65, 95%CI=0.44-0.97.The proportion of patients successfully treated did not increase with Xpert MTB/RIF implementation, with high loss to follow-up rates in both arms. We did observe a 35% reduction in TB-related mortality, which we hypothesize may be explained by less advanced disease among the smear-negative patients diagnosed by Xpert. In conclusion, XpertMTB/RIF introduction did not improve TB treatment outcomes in Brazil.clinicaltrials.gov NCT01363765.

  3. 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…

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. 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

  9. 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…

  10. 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 (...

  11. 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

  12. The Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation (MANTRA-PAF) trial: clinical rationale, study design, and implementation

    DEFF Research Database (Denmark)

    Jons, Christian; Hansen, Peter Steen; Johannessen, Arne;

    2009-01-01

    (MANTRA-PAF) trial is a randomized, controlled, parallel group, multicentre study designed to test whether catheter-based RFA is superior to optimized AAD therapy in suppressing relapse within 24 months of symptomatic and/or asymptomatic AF in patients with paroxysmal AF without prior AAD therapy...... centres in Scandinavia and Germany are participating in the study. Enrolment was started in 2005 and as of November 2008, 260 patients have been enrolled into the study. It is expected that enrolment will end by March 2009, when 300 patients have been included. CONCLUSION: The MANTRA-PAF trial...

  13. 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.

  14. 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

  15. 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

    2015-12-17

    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.

  16. 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

  17. 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.

  18. 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

  19. 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

  20. 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

  1. 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

  2. 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

  3. Internet-delivered treatment for older adults with anxiety and depression: implementation of the Wellbeing Plus Course in routine clinical care and comparison with research trial outcomes

    Science.gov (United States)

    Staples, Lauren G.; Fogliati, Vincent J.; Dear, Blake F.; Nielssen, Olav

    2016-01-01

    Background The Wellbeing Plus Course is an internet-delivered psychological intervention for older adults with anxiety or depression. Aims To compare the effectiveness of the Wellbeing Plus Course in a public health setting (clinic group) with its efficacy in a randomised controlled trial (research group). Method Participants (n=949) were Australian adults aged 60 and above. Primary outcome measures were the Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder scale (GAD-7). Results Initial symptom severity was higher in the clinic group and course completion was lower. Both groups showed significant symptom reductions at post-treatment and were satisfied with the treatment. Results were maintained at 3-month follow-up. Within-group symptom changes were comparable between settings; there were no between-group differences on primary outcomes or satisfaction. Conclusions The Wellbeing Plus Course is as effective and acceptable in routine clinical care, as it is in controlled research trials. Declaration of interest N.T. and B.F.D developed the Wellbeing Plus Course but derived no financial benefit from it. Copyright and usage © The Royal College of Psychiatrists 2016. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) license. PMID:27703794

  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. A stepped strategy that aims at the nationwide implementation of the Enhanced Recovery After Surgery programme in major gynaecological surgery: study protocol of a cluster randomised controlled trial

    NARCIS (Netherlands)

    Groot, J.J.A.M. de; Maessen, J.M.; Slangen, B.F.; Winkens, B.; Dirksen, C.D.; Weijden, T.T. van der

    2015-01-01

    BACKGROUND: Enhanced Recovery After Surgery (ERAS) programmes aim at an early recovery after surgical trauma and consequently at a reduced length of hospitalisation. This paper presents the protocol for a study that focuses on large-scale implementation of the ERAS programme in major gynaecological

  6. 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

  7. 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.

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

    NARCIS (Netherlands)

    Gaalen, J.L. van; Bakker, M.J.; Bodegom-Vos, L. van; Snoeck-Stroband, J.B.; Assendelft, W.J.J.; Kaptein, A.A.; Meer, V. van der; Taube, C.; Thoonen, B.P.A.; Sont, J.K.; for the, I.s.g.

    2012-01-01

    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 pra

  9. 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

  10. Employees' Perceptions of Social Norms as a Result of Implementing the Participatory Approach at Supervisor Level : Results of a Randomized Controlled Trial

    NARCIS (Netherlands)

    Ketelaar, S M; Schaafsma, F G; Geldof, M F; Boot, C R L; Kraaijeveld, R A; Shaw, W S; Bültmann, U; Twisk, J; Anema, J R

    2016-01-01

    Purpose A multifaceted implementation strategy was targeted at supervisors to encourage them to apply a participatory approach (PA) in dealing with employees' work functioning problems due to health concerns. This paper assesses the effect on employees' perceived social norms regarding the use of th

  11. 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.

  12. 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.

  13. 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

  14. 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.

  15. 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

  16. 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...

  17. 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...

  18. 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...

  19. 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 ...

  20. Study protocol: Cost effectiveness of two strategies to implement the NVOG guidelines on hypertension in pregnancy: An innovative strategy including a computerised decision support system compared to a common strategy of professional audit and feedback, a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Luitjes Susanne HE

    2010-09-01

    Full Text Available Abstract Background Hypertensive disease in pregnancy remains the leading cause of maternal mortality in the Netherlands. Seventeen percent of the clinical pregnancies are complicated by hypertension and 2% by preeclampsia. The Dutch Society of Obstetrics and Gynaecology (NVOG has developed evidence-based guidelines on the management of hypertension in pregnancy and chronic hypertension. Previous studies showed a low adherence rate to other NVOG guidelines and a large variation in usual care in the different hospitals. An explanation is that the NVOG has no general strategy of practical implementation and evaluation of its guidelines. The development of an effective and cost effective implementation strategy to improve adherence to the guidelines on hypertension in pregnancy is needed. Methods/Design The objective of this study is to assess the cost effectiveness of an innovative implementation strategy of the NVOG guidelines on hypertension including a computerised decision support system (BOS compared to a common strategy of professional audit and feedback. A cluster randomised controlled trial with an economic evaluation alongside will be performed. Both pregnant women who develop severe hypertension or pre-eclampsia and professionals involved in the care for these women will participate. The main outcome measures are a combined rate of major maternal complications and process indicators extracted from the guidelines. A total of 472 patients will be included in both groups. For analysis, descriptive as well as regression techniques will be used. A cost effectiveness and cost utility analysis will be performed according to the intention-to-treat principle and from a societal perspective. Cost effectiveness ratios will be calculated using bootstrapping techniques.

  1. The Design of Cluster Randomized Crossover Trials

    Science.gov (United States)

    Rietbergen, Charlotte; Moerbeek, Mirjam

    2011-01-01

    The inefficiency induced by between-cluster variation in cluster randomized (CR) trials can be reduced by implementing a crossover (CO) design. In a simple CO trial, each subject receives each treatment in random order. A powerful characteristic of this design is that each subject serves as its own control. In a CR CO trial, clusters of subjects…

  2. 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 ...

  3. 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, ...

  4. The design of cluster randomized crossover trials

    NARCIS (Netherlands)

    Rietbergen, C.; Moerbeek, M.

    2011-01-01

    The inefficiency induced by between-cluster variation in cluster randomized (CR) trials can be reduced by implementing a crossover (CO) design. In a simple CO trial, each subject receives each treatment in random order. A powerful characteristic of this design is that each subject serves as its own

  5. Intervención neurorreflejoterápica para el tratamiento de las enfermedades mecánicas del raquis: Resultados de una experiencia piloto Implementation of neuroreflexotherapy in the treatment of back pain: Results of a pilot trial

    Directory of Open Access Journals (Sweden)

    2004-08-01

    favorable y consistente con la observada en los ensayos clínicos previos. Conclusiones: La sistemática de implantación aplicada permite incorporar la intervención NRT a la práctica clínica sistemática del Sistema Nacional de Salud en las condiciones de aplicación en las que ha sido evaluada en estudios previos. El protocolo de derivación definido genera una alta tasa de remisión adecuada, un elevado grado de satisfacción entre pacientes y médicos, y unos resultados clínicos consistentes con la efectividad y seguridad previamente demostrada por esta tecnología.Background: Previous clinical trials have demonstrated the efficacy, safety, effectiveness and efficiency of neuroreflexotherapy (NRT in the treatment of subacute and chronic non-specific low back pain. The goal of this study was to describe the implementation of this method into the Spanish National Health System, to assess the viability of the referral protocol, and to obtain the data required for planning the widespread use of this technology. Method: A referral protocol was established and explained in a single clinical session in 18 health centers in Majorca (Spain. During this session, handouts of the referral protocol and a telephone number for questions were also given. After the session, the centers' physicians were authorized to refer their patients to a unit certified for NRT. Demand for this therapy, the applicability of the referral protocol, the appropriateness of referrals, and patient and physician satisfaction were quantified over a four-month period. Data were also collected on patients' clinical outcomes and on adverse effects of the treatment. Results: Of the 208 physicians, 43 referred 97 patients. The mean rate of referral per 10,000 persons affiliated with each health center was 1.07 patients per month. The rate of appropriate referral was 91.8%, with no physician having to call for assistance. Most of the referred patients had chronic, intense pain, with a poor prognosis and

  6. 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 ...

  7. Participating in Clinical Trials

    Science.gov (United States)

    ... 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 ...

  8. [PDCA Applied in Special Rectification of Medical Instrument Clinical Trial].

    Science.gov (United States)

    Wang, Lei; Qu, Xintao; Yu, Xiuchun

    2015-09-01

    PDCA cycle was applied in special rectification activities for medical instrument clinical trial, with quality criteria of implementation made. Completed medical instrument clinical trial from January 2011 to December 2012 was believed as control group, from January 2013 to December 2014 as PDCA group, the scores of clinical trial and the score rate of items were compared and analyzed. Results show quality scores of clinical trial in PDCA group are higher than that in control group (51 vs. 81, P rectification activities with PDCA applied in our department are feasible and effective. It significantly improves implement quality of medical instrument clinical trial.

  9. 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 ( ...

  10. 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

  11. Continental cement trial burn strategy follow-up

    Energy Technology Data Exchange (ETDEWEB)

    Woodford, J. [Gossman Consulting, Inc., Springboro, OH (United States); Winders, H. [Continental Cement Company, Hannibal, MO (United States); Constans, D.L. [Gossman Consulting, Inc., Peachtree City, GA (United States)

    1997-12-31

    The Continental Trial Burn strategy, presented at the 1995 BIF Conference, included the use of {open_quotes}data-in-lieu-of{close_quotes} from previous compliance testing conducted at the facility. Since the submission of the Trial Burn Plan and the 1995 presentation, Continental Cement has completed their two campaign trial burn. This paper will update the implementation of the Continental Trial Burn strategy. 1 fig., 1 tab.

  12. Challenges and lessons learned in conducting comparative-effectiveness trials.

    Science.gov (United States)

    Herrick, Linda M; Locke, G Richard; Zinsmeister, Alan R; Talley, Nicholas J

    2012-05-01

    The current health-care environment is demanding evidence-based medicine that relies on clinical trials as the basis for decisions. Clinician investigators are more often finding that they are personally responsible for coordinating large, multisite trials. We present strategies for successful implementation and management of multisite clinical trials and knowledge gained through an international, multisite randomized clinical trial. Topics include team composition, regulatory requirements, study organization and governance, communication strategies, recruitment and retention efforts, budget, technology transfer, and publication.

  13. 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.

  14. 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

  15. Pilot implementation

    DEFF Research Database (Denmark)

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

    2012-01-01

    implementation and provide three empirical illustrations of our model. We conclude that pilot implementation has much merit as an ISD technique when system performance is contingent on context. But we also warn developers that, despite their seductive conceptual simplicity, pilot implementations can be difficult...

  16. 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...

  17. 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 ...

  18. 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 ...

  19. 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 ...

  20. 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 ...

  1. 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 ...

  2. Data monitoring committees for pragmatic clinical trials.

    Science.gov (United States)

    Ellenberg, Susan S; Culbertson, Richard; Gillen, Daniel L; Goodman, Steven; Schrandt, Suzanne; Zirkle, Maryan

    2015-10-01

    In any clinical trial, it is essential to monitor the accumulating data to be sure that the trial continues to be safe for participants and that the trial is being conducted properly. Data monitoring committees, independent expert panels who undertake regular reviews of the data as the trial progresses, serve an important role in safeguarding the interests of research participants and ensuring trial integrity in many trials. Many pragmatic clinical trials, which aim to inform healthcare decisions by comparing alternate interventions in heterogeneous healthcare delivery settings, will warrant review by an independent data monitoring committee due to their potential impact on clinical practice. However, the very features that make a trial "pragmatic" may pose challenges in terms of which aspects of a trial to monitor and when it is appropriate for a data monitoring committee to intervene. Using the Pragmatic-Explanatory Continuum Indicator Summary tool that draws distinctions between pragmatic and explanatory clinical trials, we review characteristics of pragmatic clinical trials that may have implications for data monitoring committees and interim monitoring plans. These include broad eligibility criteria, a focus on subjective patient-centered outcomes, and in some cases a lack of standardized follow-up procedures across study sites. Additionally, protocol adherence is often purposefully not addressed in pragmatic trials in order to accurately represent the clinical practice setting and maintain practicability of implementation; there are differing viewpoints as to whether adherence should be assessed and acted upon by data monitoring committees in these trials. Some other issues not specifically related to the Pragmatic-Explanatory Continuum Indicator Summary criteria may also merit special consideration in pragmatic trials. Thresholds for early termination of a pragmatic clinical trial might be controversial. The distinguishing features of pragmatic clinical

  3. 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

  4. Trial encoding algorithms ensemble.

    Science.gov (United States)

    Cheng, Lipin Bill; Yeh, Ren Jye

    2013-01-01

    This paper proposes trial algorithms for some basic components in cryptography and lossless bit compression. The symmetric encryption is accomplished by mixing up randomizations and scrambling with hashing of the key playing an essential role. The digital signature is adapted from the Hill cipher with the verification key matrices incorporating un-invertible parts to hide the signature matrix. The hash is a straight running summation (addition chain) of data bytes plus some randomization. One simplified version can be burst error correcting code. The lossless bit compressor is the Shannon-Fano coding that is less optimal than the later Huffman and Arithmetic coding, but can be conveniently implemented without the use of a tree structure and improvable with bytes concatenation.

  5. Pilot implementation

    DEFF Research Database (Denmark)

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

    2012-01-01

    A recurrent problem in information-systems development (ISD) is that many design shortcomings are not detected during development, but first after the system has been delivered and implemented in its intended environment. Pilot implementations appear to promise a way to extend prototyping from...... the laboratory to the field, thereby allowing users to experience a system design under realistic conditions and developers to get feedback from realistic use while the design is still malleable. We characterize pilot implementation, contrast it with prototyping, propose a five-element model of pilot...... implementation, and provide three empirical illustrations of our model. We conclude that pilot implementation has much merit as an ISD technique when system performance is contingent on context. But we also warn developers that, despite their seductive conceptual simplicity, pilot implementations can...

  6. Engagement of the community, traditional leaders, and public health system in the design and implementation of a large community-based, cluster-randomized trial of umbilical cord care in Zambia.

    Science.gov (United States)

    Hamer, Davidson H; Herlihy, Julie M; Musokotwane, Kebby; Banda, Bowen; Mpamba, Chipo; Mwangelwa, Boyd; Pilingana, Portipher; Thea, Donald M; Simon, Jonathon L; Yeboah-Antwi, Kojo; Grogan, Caroline; Semrau, Katherine E A

    2015-03-01

    Conducting research in areas with diverse cultures requires attention to community sensitization and involvement. The process of community engagement is described for a large community-based, cluster-randomized, controlled trial comparing daily 4% chlorhexidine umbilical cord wash to dry cord care for neonatal mortality prevention in Southern Province, Zambia. Study preparations required baseline formative ethnographic research, substantial community sensitization, and engagement with three levels of stakeholders, each necessitating different strategies. Cluster-specific birth notification systems developed with traditional leadership and community members using community-selected data collectors resulted in a post-natal home visit within 48 hours of birth in 96% of births. Of 39,679 pregnant women enrolled (93% of the target of 42,570), only 3.7% were lost to follow-up or withdrew antenatally; 0.2% live-born neonates were lost by day 28 of follow-up. Conducting this trial in close collaboration with traditional, administrative, political, and community stakeholders facilitated excellent study participation, despite structural and sociocultural challenges. PMID:25646254

  7. 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

  8. 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…

  9. 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.

  10. Paperless clinical trials: Myth or reality?

    Science.gov (United States)

    Gupta, Sandeep K.

    2015-01-01

    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. PMID:26288464

  11. 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

  12. 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

  13. 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...

  14. 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.

  15. There's a Bug in Your Ear!: Using Technology to Increase the Accuracy of DTT Implementation

    Science.gov (United States)

    McKinney, Tracy; Vasquez, Eleazar, III.

    2014-01-01

    Many professionals have successfully implemented discrete trial teaching in the past. However, there have not been extensive studies examining the accuracy of discrete trial teaching implementation. This study investigated the use of Bug in Ear feedback on the accuracy of discrete trial teaching implementation among two pre-service teachers…

  16. A pragmatic randomized control trial and realist evaluation on the implementation and effectiveness of an internet application to support self-management among individuals seeking specialized mental health care: a study protocol

    Directory of Open Access Journals (Sweden)

    Jennifer M. Hensel

    2016-10-01

    Full Text Available Abstract Background Mental illness is a substantial and rising contributor to the global burden of disease. Access to and utilization of mental health care, however, is limited by structural barriers such as specialist availability, time, out-of-pocket costs, and attitudinal barriers including stigma. Innovative solutions like virtual care are rapidly entering the health care domain. The advancement and adoption of virtual care for mental health, however, often occurs in the absence of rigorous evaluation and adequate planning for sustainability and spread. Methods A pragmatic randomized controlled trial with a nested comparative effectiveness arm, and concurrent realist process evaluation to examine acceptability, effectiveness, and cost-effectiveness of the Big White Wall (BWW online platform for mental health self-management and peer support among individuals aged 16 and older who are accessing mental health services in Ontario, Canada. Participants will be randomized to 3 months of BWW or treatment as usual. At the end of the 3 months, participants in the intervention group will have the opportunity to opt-in to an intervention extension arm. Those who opt-in will be randomized to receive an additional 3 months of BWW or no additional intervention. The primary outcome is recovery at 3 months as measured by the Recovery Assessment Scale-revised (RAS-r. Secondary outcomes include symptoms of depression and anxiety measured with the Personal Health Questionnaire-9 item (PHQ-9 and the Generalized Anxiety Disorder Questionnaire-7 item (GAD-7 respectively, quality of life measured with the EQ-5D-5L, and community integration assessed with the Community Integration Questionnaire. Cost-effectiveness evaluations will account for the cost of the intervention and direct health care costs. Qualitative interviews with participants and stakeholders will be conducted throughout. Discussion Understanding the impact of virtual strategies, such as BWW, on

  17. 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 ...

  18. 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 ...

  19. 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.

  20. 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...

  1. 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...

  2. 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 ...

  3. Organising trials by themes

    NARCIS (Netherlands)

    Hop, M.E.C.M.

    2013-01-01

    In recent years in the Netherlands the demand for a different type of cultivar trial has increased: the themed trial. Themed trials gather information on one property of a range of garden plants, like their winter hardiness or scent, or research the suitability of a range of plants for a specific us

  4. 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...

  5. Implementing TQM.

    Science.gov (United States)

    Bull, G; Maffetone, M A; Miller, S K

    1992-01-01

    Total quality management (TQM) is an organized, systematic approach to problem solving and continuous improvement. American corporations have found that TQM is an excellent way to improve competitiveness, lower operating costs, and improve productivity. Increasing numbers of laboratories are investigating the benefits of TQM. For this month's column, we asked our respondents: What steps has your laboratory taken to implement TQM?

  6. 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...

  7. 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.

  8. 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

  9. 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

  10. 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...... of antiandrogen (flutamide, Anandron, or cyproterone acetate) added to castration. This paper reviews the different types of heterogeneity that might exist among trials that are involved in the overview: study design, randomization procedure, treatment evaluation, statistical evaluation, and data maturity...

  11. Clinical Research Methodology 3: Randomized Controlled Trials.

    Science.gov (United States)

    Sessler, Daniel I; Imrey, Peter B

    2015-10-01

    Randomized assignment of treatment excludes reverse causation and selection bias and, in sufficiently large studies, effectively prevents confounding. Well-implemented blinding prevents measurement bias. Studies that include these protections are called randomized, blinded clinical trials and, when conducted with sufficient numbers of patients, provide the most valid results. Although conceptually straightforward, design of clinical trials requires thoughtful trade-offs among competing approaches-all of which influence the number of patients required, enrollment time, internal and external validity, ability to evaluate interactions among treatments, and cost.

  12. Financial managers' costing expertise is needed in clinical trials.

    Science.gov (United States)

    West, D A; Balas, E A; West, T D

    2000-01-01

    In addition to providing comparable and verifiable evidence regarding outcomes, clinical trials could also serve as sources of accurate and replicable financial information. Trial reports that identify expenses associated with effective diagnostic and therapeutic interventions enable cost controls. Standardized cost calculations could help clinicians and administrators identify more efficient health care technologies. Unfortunately, relatively few published trials include economic analyses and when they do, data are incomplete. Based on analyses of 97 clinical trial reports, this article proposes a standard costing format. Health care financial managers have the costing expertise necessary to implement and interpret standardized cost calculations for clinical trials. With the active involvement of financial managers, a standard costing format for clinical trials can be achieved. PMID:10961828

  13. 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

  14. 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 ...

  15. 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 ...

  16. 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 ...

  17. 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 ...

  18. 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 ...

  19. 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...

  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...... both academia and industry, convened to discuss issues related to soluble biomarkers and to make recommendations for their use in OA clinical trials based on current knowledge and anticipated benefits. This document summarizes current guidance on use of biomarkers in OA clinical trials...... and their utility at five stages, including preclinical development and phase I to phase IV trials. As demonstrated by this summary, biomarkers can provide value at all stages of therapeutics development. When resources permit, we recommend collection of biospecimens in all OA clinical trials for a wide variety...

  1. 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

  2. ENS implementation

    Energy Technology Data Exchange (ETDEWEB)

    Teodorescu, R.; Blaabjerg, F.; Asiminoaei, L.; Timbus, A.V.

    2004-07-01

    This report is part of the research contract PSO-Eltra 2524/2003 where Aalborg University did cooperated with PowerLynx A/S for the development of the ENS function for the PowerLynx PV inverters. The work started 01.01.03 and ended 29.02.04 and involved Frede Blaabjerg, Remus Teodorescu, Lucian Asiminoaie and Adrian Timbus from Aalborg University and Uffe Borup from PowerLynx A/S. The objective was to make the PowerLynx PV inverters compatible with the german ENS standard which mainly consist in the requirement to disconnect from the grid in max. 2 seconds if the grid impedance is changed with 0.5 ohms resistive. During 01.07 31.08 2003, an algorithm based on the injection of a voltage of 75 Hz and the on-line measurement the 75Hz component from the grid current and voltage using simplified DFT was developed by Uffe Borup, Remus Teodorescu and Lucian Asiminoaie. The algorithm is described in detail in the report 'ENS design' enclosed in Appendix A and in the two published paper (final paper for APEC'04 and approved digest for PESC'04). Then the algorithm was finally implemented and the experimental tests carried out proved to be satisfactory as shown in chapter 2 'ENS implementation'. Very few missed tests were recorded on very high inductive grid (0.6 + 1.1i) when the reactance is higher than the resistance. In the period 03.02.04 13.02.04 some attempts was done in order to improve the detection by compensating the delay in the voltage measurement but no improvement was noticed. Thus, these last minute changes was not included in the final version of the software. Finally, the detection mechanism of another PV running in parallel that injects t5Hz for ENS grid measurements has been done. The code for parallel ENS is also enclosed. (au)

  3. Flaw detection trial using virtual ultrasonic testing

    Energy Technology Data Exchange (ETDEWEB)

    Sarkimo, M. (VTT Technical Research Centre of Finland, Espoo (Finland))

    2010-05-15

    This report presents features of ultrasonic simulation and aspects to be considered in virtual inspection trials. A simulation trial implementation and results are reported, with main purpose to test different features of the selected simulation software in creation and analysis of a virtual detectability trial. A series of simulations was conducted using simple test block geometry that included notch shaped flaws with varying depths. To make the case realistic, significant structural noise and moderate attenuation were added to the simulation using the material properties settings. The simulation was run using different probe frequency values and crystal dimensions to produce variation in the flaw detectability.The simulated ultrasonic inspection data was analyzed using analysis tools of the used software. The signal-to-noise ratios and locations of the detected indications were characterized and detectability dependence on the notch height was assessed. Also, study about signal-to-noise ratios measured from the detected indications was performed. (orig.)

  4. 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 ...

  5. 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...... of antiandrogen (flutamide, Anandron, or cyproterone acetate) added to castration. This paper reviews the different types of heterogeneity that might exist among trials that are involved in the overview: study design, randomization procedure, treatment evaluation, statistical evaluation, and data maturity...... with a larger number of patients and a longer follow-up will contribute more to the overview's results....

  6. 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

  7. Using e-technologies in clinical trials.

    Science.gov (United States)

    Rosa, Carmen; Campbell, Aimee N C; Miele, Gloria M; Brunner, Meg; Winstanley, Erin L

    2015-11-01

    Clinical trials have been slow to incorporate e-technology (digital and electronic technology that utilizes mobile devices or the Internet) into the design and execution of studies. In the meantime, individuals and corporations are relying more on electronic platforms and most have incorporated such technology into their daily lives. This paper provides a general overview of the use of e-technologies in clinical trials research, specifically within the last decade, marked by rapid growth of mobile and Internet-based tools. Benefits of and challenges to the use of e-technologies in data collection, recruitment and retention, delivery of interventions, and dissemination are provided, as well as a description of the current status of regulatory oversight of e-technologies in clinical trials research. As an example of ways in which e-technologies can be used for intervention delivery, a summary of e-technologies for treatment of substance use disorders is presented. Using e-technologies to design and implement clinical trials has the potential to reach a wide audience, making trials more efficient while also reducing costs; however, researchers should be cautious when adopting these tools given the many challenges in using new technologies, as well as threats to participant privacy/confidentiality. Challenges of using e-technologies can be overcome with careful planning, useful partnerships, and forethought. The role of web- and smartphone-based applications is expanding, and the increasing use of those platforms by scientists and the public alike make them tools that cannot be ignored.

  8. 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 ...

  9. 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, ...

  10. Anchor Trial Launch

    Science.gov (United States)

    NCI has launched a multicenter phase III clinical trial called the ANCHOR Study -- Anal Cancer HSIL (High-grade Squamous Intraepithelial Lesion) Outcomes Research Study -- to determine if treatment of HSIL in HIV-infected individuals can prevent anal canc

  11. 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 ...

  12. 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 ...

  13. 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 ...

  14. 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...

  15. 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...

  16. 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 ...

  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. High impact of implementation on school-based smoking prevention

    DEFF Research Database (Denmark)

    Bast, Lotus Sofie; Due, Pernille; Bendtsen, Pernille;

    2016-01-01

    BACKGROUND: Implementation fidelity describes how well an intervention is implemented in the real-world setting. Assessing implementation fidelity is essential in the understanding of intervention results. In most studies, implementation fidelity is measured insufficiently, though, not taking...... into account the complexity of the concept nor the intervention. The objective of the present study was to develop an overall quantitative measure of implementation fidelity, to examine the degree of implementation fidelity and the association of implementation and effect of a randomized school-based smoking...... prevention trial-the X:IT study. METHODS: A cluster-randomized trial testing is a multi-component intervention to prevent smoking among adolescents in 94 Danish elementary schools (51 intervention, 43 control schools). Participants were grade 7 pupils (mean age 12.5 years). Data was collected by electronic...

  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. 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...

  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. The opportunities and challenges of pragmatic point-of-care randomised trials using routinely collected electronic records : evaluations of two exemplar trials

    NARCIS (Netherlands)

    van Staa, Tjeerd-Pieter; Dyson, Lisa; McCann, Gerard; Padmanabhan, Shivani; Belatri, Rabah; Goldacre, Ben; Cassell, Jackie; Pirmohamed, Munir; Torgerson, David; Ronaldson, Sarah; Adamson, Joy; Taweel, Adel; Delaney, Brendan; Mahmood, Samhar; Baracaia, Simona; Round, Thomas; Fox, Robin; Hunter, Tommy; Gulliford, Martin; Smeeth, Liam

    2014-01-01

    BACKGROUND: Pragmatic trials compare the effects of different decisions in usual clinical practice. OBJECTIVES: To develop and evaluate methods to implement simple pragmatic trials using routinely collected electronic health records (EHRs) and recruiting patients at the point of care; to identify th

  3. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

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

    2015-01-01

    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...... and index knee, describing interventions, patient-reported and physical performance measures, structural outcome measures, biochemical biomarkers, and reporting recommendations. In summary, the working group identified 25 recommendations that represent the current best practices regarding clinical trials...

  4. Bayesian methods for the design and analysis of noninferiority trials.

    Science.gov (United States)

    Gamalo-Siebers, Margaret; Gao, Aijun; Lakshminarayanan, Mani; Liu, Guanghan; Natanegara, Fanni; Railkar, Radha; Schmidli, Heinz; Song, Guochen

    2016-01-01

    The gold standard for evaluating treatment efficacy of a medical product is a placebo-controlled trial. However, when the use of placebo is considered to be unethical or impractical, a viable alternative for evaluating treatment efficacy is through a noninferiority (NI) study where a test treatment is compared to an active control treatment. The minimal objective of such a study is to determine whether the test treatment is superior to placebo. An assumption is made that if the active control treatment remains efficacious, as was observed when it was compared against placebo, then a test treatment that has comparable efficacy with the active control, within a certain range, must also be superior to placebo. Because of this assumption, the design, implementation, and analysis of NI trials present challenges for sponsors and regulators. In designing and analyzing NI trials, substantial historical data are often required on the active control treatment and placebo. Bayesian approaches provide a natural framework for synthesizing the historical data in the form of prior distributions that can effectively be used in design and analysis of a NI clinical trial. Despite a flurry of recent research activities in the area of Bayesian approaches in medical product development, there are still substantial gaps in recognition and acceptance of Bayesian approaches in NI trial design and analysis. The Bayesian Scientific Working Group of the Drug Information Association provides a coordinated effort to target the education and implementation issues on Bayesian approaches for NI trials. In this article, we provide a review of both frequentist and Bayesian approaches in NI trials, and elaborate on the implementation for two common Bayesian methods including hierarchical prior method and meta-analytic-predictive approach. Simulations are conducted to investigate the properties of the Bayesian methods, and some real clinical trial examples are presented for illustration.

  5. 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 ...

  6. 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 ...

  7. 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 ...

  8. The ONTARGET trial programme

    DEFF Research Database (Denmark)

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

    2009-01-01

    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...

  9. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Emery, C. A.; Roos, Ewa M.; Verhagen, E.;

    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...

  10. 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 ...

  11. 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, & ...

  12. 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...

  13. The FOCUS trial

    DEFF Research Database (Denmark)

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

    2015-01-01

    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 treatment...

  14. A multifaceted implementation strategy versus passive implementation of low back pain guidelines in general practice

    DEFF Research Database (Denmark)

    Riis, Allan; Jensen, Cathrine Elgaard; Bro, Flemming;

    2016-01-01

    primary care to secondary care. The primary aim of this project was to reduce secondary care referral within 12 weeks by a multifaceted implementation strategy (MuIS). METHODS: In a cluster randomised design, 189 general practices from the North Denmark Region were invited to participate. Practices were...... randomised (1:1) and stratified by practice size to MuIS (28 practices) or a passive implementation strategy (PaIS; 32 practices). Included were patients with LBP aged 18 to 65 years who were able to complete questionnaires, had no serious underlying pathology, and were not pregnant. We developed a Mu.......31 to 0.81; p = 0.004]). CONCLUSIONS: Using a MuIS changed general practice referral behaviour and was cost effective, but patients in the MuIS group were less satisfied. This study supports the application of a MuIS when implementing guidelines. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01699256....

  15. 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 ...

  16. 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

  17. The Trial of Katherine Harrison.

    Science.gov (United States)

    Woodward, Walter W.

    2003-01-01

    Presents a lesson plan in which the teacher and students participate in a mock trial of Katherine Harrison, who was accused of witchcraft in the seventeenth century. Provides background information about the trial, as well as primary sources of the testimonies given by witnesses during the trial. (CMK)

  18. Registration of randomized clinical trials

    DEFF Research Database (Denmark)

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

    2015-01-01

    starting enrolment before 2010 to 63.2% after 2010 (24/38, P clinical trials were registered at clinicaltrials.gov. CONCLUSION: Many published randomized controlled trials from Acta Anaesthesiologica Scandinavica were not adequately registered but the requirement of trial registration has...

  19. 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.

  20. Comprehensive Quality Management (CQM) in the PLCO Trial.

    Science.gov (United States)

    Gohagan, John K; O'Brien, Barbara; Hasson, Marsha A; Umbel, Keith D; Bridgeman, Beth; Kramer, Barnett S; Reding, Douglas; Gren, Lisa; Wright, Patrick; Riley, Thomas; Prorok, Philip C

    2015-01-01

    The NCI imbedded the notion of comprehensive quality control and assurance (CQA) in the design concept for the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial. PLCO implemented a comprehensive, adaptable quality assurance and control program to span more than 20 years of data collection, coordinate multiple institutions and committees, and integrate a wide variety of complex protocols. CQA concepts, practices, and procedures traced through all aspects of trial management, governance, and operations of PLCO. The driving force behind CQA in PLCO was scientific and clinical credibility of trial data and findings. CQA as implemented in PLCO was operationally analogous to the concept of Total Quality Management (TQM) described in the management literature. This paper describes CQA actualization in PLCO.

  1. Lost Hills Field Trial - incorporating new technology for resevoir management

    Science.gov (United States)

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

    2002-01-01

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

  2. European Randomized Lung Cancer Screening Trials : Post NLST

    NARCIS (Netherlands)

    Field, John K.; van Klaveren, Rob; Pedersen, Jesper H.; Pastorino, Ugo; Paci, Eugino; Becker, Nikolauss; Infante, Maurizo; Oudkerk, Matthijs; de Koning, Harry J.

    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 tri

  3. 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.

  4. Are clinical trial results transferable in the real life?

    Science.gov (United States)

    Natale, Enrico; Marsocci, Alfiera

    2016-06-22

    Generally in the clinical practice patients are more complex in comparison with those included in the clinical trials. In this article, we discuss three relevant items, which may implement the transferability of the clinical trial results in the real world. The observational studies have fewer restrictions on the number of patients included, due to more relaxed inclusion and exlusion criteria than in randomized clinical trials. The absence of randomization however may lead to potential for bias. The recurrent event analysis may extend the positive results of clinical trials regarding the reductions of the first primary endpoint event to total events, including those beyond the first event. This analysis is of great interest in the clinical practice, where recurrent events are common. Finally the reliability of subgroup analysis is discussed. Pre-specified subgroup analyses are more credible and valuable than post-hoc analyses.

  5. The COLOFOL trial

    DEFF Research Database (Denmark)

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

    2016-01-01

    in tumor location and stage distribution, with 5.6% more patients in the randomized group having colon cancer and 6.7% more patients having stage II disease. CONCLUSION: Patients in the two study arms were not only demographically similar, but also similar to nonincluded eligible patients, apart from stage......INTRODUCTION: The COLOFOL trial, a prospective randomized multicenter trial comparing two follow-up regimes after curative surgical treatment for colorectal cancer, focuses on detection of asymptomatic recurrences. This paper aims to describe the design and recruitment procedure in the COLOFOL...... population. To be eligible, patients had to be 75 years or younger and curatively resected for stage II or III colorectal cancer. Exclusion criteria were hereditary colorectal cancer, no signed consent, other malignancy, and life expectancy less than 2 years due to concomitant disease. In four of the 24...

  6. 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...

  7. 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....

  8. 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.

  9. 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.

  10. 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

  11. 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

  12. 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

  13. 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...

  14. 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

  15. 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

  16. 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.

  17. 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.

  18. 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

  19. Gateways to clinical trials.

    Science.gov (United States)

    Tomillero, A; Moral, M A

    2009-09-01

    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: AAV1/SERCA2a, Abacavir sulfate/lamivudine, Adalimumab, Aliskiren fumarate, Ambrisentan, Aripiprazole, AT-7519, Atazanavir sulfate, Atomoxetine hydrochloride, Azacitidine, Azelnidipine; Besifloxacin hydrochloride, Bevacizumab, Bioabsorbable everolimus-eluting coronary stent, Bortezomib, Bosentan, Budesonide/formoterol fumarate; CAIV-T, Carisbamate, Casopitant mesylate, Certolizumab pegol, Cetuximab, Ciclesonide, Ciprofloxacin/dexamethasone, CTCE-9908; Dalcetrapib, Darunavir, Deferasirox, Desloratadine, Disitertide, Drotrecogin alfa (activated), DTA-H19, Duloxetine hydrochloride, Dutasteride; Ecogramostim, Efalizumab, Emtricitabine, Eribulin mesilate, Escitalopram oxalate, Eszopiclone, EUR-1008, Everolimus-eluting coronary stent, Exenatide; Fampridine, Fluticasone furoate, Formoterol fumarate/fluticasone propionate, Fosamprenavir calcium, Fulvestrant; Gabapentin enacarbil, GS-7904L; HPV-6/11/16/18, Human Secretin, Hydralazine hydrochloride/isosorbide dinitrate; Imatinib mesylate, Imexon, Inalimarev/Falimarev, Indacaterol, Indacaterol maleate, Inhalable human insulin, Insulin detemir, Insulin glargine, Ixabepilone; L-Alanosine, Lapatinib ditosylate, Lenalidomide, Levocetirizine dihydrochloride, Liraglutide, Lisdexamfetamine mesilate, Lopinavir, Loratadine/montelukast sodium, Lutropin alfa; MeNZB, Mepolizumab, Micafungin sodium, Morphine hydrochloride; Nabiximols, Nikkomycin Z; Olmesartan medoxomil, Omalizumab; Paclitaxel-eluting stent, Pegfilgrastim, Peginterferon alfa-2a, Peginterferon alfa-2b, Perifosine, PF-489791, Plitidepsin, Posaconazole, Pregabalin; QAX-576; Raltegravir potassium, Ramelteon, Rasagiline

  20. 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

  1. 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

  2. The CHANGE trial

    DEFF Research Database (Denmark)

    Speyer, Helene; Christian Brix Nørgaard, Hans; Birk, Merete;

    2016-01-01

    Life expectancy in patients with schizophrenia is reduced by 20 years for men and 15 years for women compared to the general population. About 60% of the excess mortality is due to physical illnesses, with cardiovascular disease being dominant. CHANGE was a randomized, parallel-group, superiority...... cardiorespiratory fitness, physical activity, weight, diet and smoking. In conclusion, the CHANGE trial did not support superiority of individual lifestyle coaching or care coordination compared to treatment as usual in reducing cardiovascular risk in patients with schizophrenia spectrum disorders and abdominal...

  3. 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....

  4. 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)

  5. 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

  6. 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

  7. 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....

  8. 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....

  9. 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...

  10. Implementing Student Information Systems

    Science.gov (United States)

    Sullivan, Laurie; Porter, Rebecca

    2006-01-01

    Implementing an enterprise resource planning system is a complex undertaking. Careful planning, management, communication, and staffing can make the difference between a successful and unsuccessful implementation. (Contains 3 tables.)

  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. Field trial evaluation of a reo-coronavirus calf diarrhea vaccine.

    Science.gov (United States)

    Thurber, E T; Bass, E P; Beckenhauer, W H

    1977-01-01

    Field trials were conducted using an experimental, modified live virus, oral vaccine for prevention of reo- and coronavirus calf diarrhea. Prior to the trials, one or both of the specific causative agents were identified from affected calves in each participating herd. In 21 herds, sequential trials were conducted in which results of uninterrupted vaccination were compared with disease rates during a preceding or subsequent control period. In these herds there was a statistically significant reduction in the morbidity and mortality from disease in 1,598 vaccinates compared with the rates in 829 prevaccination control calves. Morbidity and mortality in 206 post-vaccination control calves rose marginally above the rates in the same vaccinates. In 26 other herds, where double blind trials were conducted, rates of morbidity and mortality from disease were virtually the same for 1,080 vaccinated calves and 355 placebo calves. Vaccinates in the sequential trials had the lowest morbidity and mortality rates of any test group in either field trial format. In a selected dairy herd, both field trial formats were implemented and the results compared. In the double blind trial, vaccinates and placebo calves had comparable rates of morbidity and mortality from disease. When a sequential trial was later implemented, a statistically significant reduction in morbidity and mortality occurred in vaccinates compared with rates in control calves. PMID:193622

  13. 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).

  14. 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).

  15. 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)

  16. Conducting qualitative research within Clinical Trials Units: avoiding potential pitfalls.

    Science.gov (United States)

    Cooper, Cindy; O'Cathain, Alicia; Hind, Danny; Adamson, Joy; Lawton, Julia; Baird, Wendy

    2014-07-01

    The value of using qualitative research within or alongside randomised controlled trials (RCTs) is becoming more widely accepted. Qualitative research may be conducted concurrently with pilot or full RCTs to understand the feasibility and acceptability of the interventions being tested, or to improve trial conduct. Clinical Trials Units (CTUs) in the United Kingdom (UK) manage large numbers of RCTs and, increasingly, manage the qualitative research or collaborate with qualitative researchers external to the CTU. CTUs are beginning to explicitly manage the process, for example, through the use of standard operating procedures for designing and implementing qualitative research with trials. We reviewed the experiences of two UK Clinical Research Collaboration (UKCRC) registered CTUs of conducting qualitative research concurrently with RCTs. Drawing on experiences gained from 15 studies, we identify the potential for the qualitative research to undermine the successful completion or scientific integrity of RCTs. We show that potential problems can arise from feedback of interim or final qualitative findings to members of the trial team or beyond, in particular reporting qualitative findings whilst the trial is on-going. The problems include: We make recommendations for improving the management of qualitative research within CTUs.

  17. Gateways to clinical trials.

    Science.gov (United States)

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

    2005-01-01

    Gateways to Clinical Trials are 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: (-)-Epigallocatechin gallate; ACP-103, Ad.Egr.TNF.11 D, adalimumab, AF-IL 12, AIDSVAX gp120 B/B, alefacept, alemtuzumab, a-Galactosylceramide, ALVAC vCP 1452, alvimopan hydrate, alvocidib hydrochloride, aminolevulinic acid hydrochloride, aminolevulinic acid methyl ester, anakinra, anidulafungin, antarelix, aprepitant, aripiprazole, arsenic sulfide, asoprisnil, atazanavir sulfate, atomoxetine hydrochloride; Bevacizumab, bimatoprost, BMS-184476, bortezomib, bosentan, botulinum toxin type B, BrachySil, brivudine; Caffeine, calcipotriol/betamethasone dipropionate, cannabidiol, capsaicin for injection, caspofungin acetate, CC-4047, cetuximab, CGP-36742, clofazimine, CpG-7909, Cypher; Darbepoetin alfa, dextromethorphan/quinidine sulfate, dimethylfumarate, dronabinol/cannabidiol, drotrecogin alfa (activated), duloxetine hydrochloride, dutasteride; Ecogramostim, efalizumab, eletriptan, emtricitabine, enfuvirtide, eplerenone, esomeprazole magnesium, estradiol acetate, eszopiclone, etoricoxib, exenatide, ezetimibe, ezetimibe/simvastatin; Fampridine, fondaparinux sodium, fosamprenavir calcium; Gefitinib, GPI-0100; hA 20, HTU-PA, human insulin, HuOKT 3 gamma 1(Ala 234-Ala 235), hyaluronic acid; Icatibant, imatinib mesylate, Indiplon, INKP-100, INKP-102, iodine (I131) tositumomab, istradefylline, IV gamma-globulin, ivabradine hydrochloride, ixabepilone; Lacosamide, landiolol, lanthanum carbonate, lasofoxifene tartrate, LB-80380, lenalidomide, lidocaine/tetracaine, linezolid, liposomal doxorubicin, liposomal vincristine sulfate, lopinavir, lopinavir/ritonavir, lumiracoxib, lurtotecan; Maribavir, morphine glucuronide, MVA-5 T

  18. Gateways to clinical trials.

    Science.gov (United States)

    Tomillero, A; Moral, M A

    2008-09-01

    Gateways to Clinical Trials are 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: ABT-263, AC-2307, Aclidinium bromide, Adefovir dipivoxil, ADH-1, Agatolimod sodium, Alefacept, Aliskiren fumarate, Aminolevulinic acid methyl ester, Anakinra, Apaziquone, Aprepitant, Aripiprazole, ASM-8, Atiprimod hydrochloride, AVE-0277, AVE-1642, AVE-8062, Axitinib, Azacitidine, AZD-0530; Bazedoxifene acetate, Bevacizumab, Bexarotene, BI-2536, Biphasic insulin aspart, BMS-387032, BMS-663513, Bortezomib, BQ-123, Brivanib alaninate, BSI-201; Caspofungin acetate, CDX-110, Cetuximab, Ciclesonide, CR-011, Cypher; Daptomycin, Darbepoetin alfa, Dasatinib, Decitabine, Deferasirox, Denosumab, Dexlansoprazole, Dexmethylphenidate hydrochloride, DNA-Hsp65 vaccine, Dovitinib, Drotrecogin alfa (activated), DTaP-HBV-IPV/Hibvaccine, DTaP-IPV-HB-PRP-T, Duloxetine hydrochloride, Dutasteride; Ecogramostim, Elacytarabine, Emtricitabine, Endothelin, Entecavir, Eplivanserin fumarate, Escitalopram oxalate, Everolimus, Ezetimibe, Ezetimibe/simvastatin; Farletuzumab, Fesoterodine fumarate, Fibrin sealant (human), Fulvestrant; Gefitinib, Gemtuzumab ozogamicin, Glufosfamide, GSK-1562902A; Hib-TT; Imatinib mesylate, IMC-11F8, Imidazoacridinone, IMP-321, INCB-18424, Indiplon, Indisulam, INNO-406, Irinotecan hydrochloride/Floxuridine, ITF-2357, Ixabepilone; KRN-951; Lasofoxifene tartrate; Lenalidomide, LGD-4665, Lonafarnib, Lubiprostone, Lumiliximab; MDX-1100, Melan-A/MART-1/gp100/IFN-alfa, Methyl-CDDO, Metreleptin, MLN-2704, Mycophenolic acid sodium salt; Na-ASP-2, Naproxcinod, Nilotinib hydrochloride monohydrate, NPI-2358; Oblimersen sodium, Odanacatib; Paclitaxel nanoparticles, PAN-811, Panobinostat, PBI-1402, PC-515, Peginterferon alfa

  19. 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.

  20. 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

  1. 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)

  2. 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...

  3. 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

  4. 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

  5. Impact and Implementation Analyses of the ELM Kindergarten Mathematics Intervention

    Science.gov (United States)

    Doabler, Christian; Baker, Scott K.; Smolkowski, Keith; Fien, Hank; Clarke, Ben; Cary, Mari Strand; Chard, David

    2011-01-01

    The purpose of this 4-year efficacy trial, funded by IES under the Mathematics and Science Education topic, is to study the efficacy of a (Tier 1) core kindergarten math curriculum, "Early Learning in Mathematics" (ELM), when implemented under rigorous experimental conditions. In the first year of this study (2008-09), kindergarten classrooms…

  6. 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,…

  7. Implementation of locally adapted guidelines on type 2 diabetes

    NARCIS (Netherlands)

    van Bruggen, Rykel; Gorter, Kees J.; Stolk, Roland P.; Verhoeven, Rob P.; Rutten, Guy E. H. M.

    2008-01-01

    Objective. To assess the effects of a facilitator enhanced multifaceted intervention to implement a locally adapted guideline on the shared care for people with type 2 diabetes. Methods. During 1 year a cluster-randomized trial was performed in 30 general practices. In the intervention group, nurse

  8. Challenges and Dilemmas in Implementing Random Assignment in Educational Research

    Science.gov (United States)

    Ong-Dean, Colin; Hofstetter, Carolyn Huie; Strick, Betsy R.

    2011-01-01

    In the contentious debate over the use of randomized clinical trials (RCTs) in education research, little attention has been given to how methodological issues arise and/or are resolved in the implementation of random assignment. Following a review of the methodological-theoretical literature on RCTs and alternative research designs, this article…

  9. 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

  10. 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

  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. 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.

  13. 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

  14. Alcolocks : factors influencing implementation, participation and compliance : literature review contributed to the EU project Alcolock Implementation in the European Union.

    NARCIS (Netherlands)

    Mathijssen, M.P.M.

    2007-01-01

    In 2004-2005, a series of alcolock field trials were conducted in four European countries, in the framework of the EU research project Alcolock Implementation in the European Union. This project was granted by the European Commission, Directorate-General for Energy and Transport (DG-TREN). As part o

  15. [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

  16. 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

  17. 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.

  18. 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. |

  19. 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.

  20. 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

  1. Effects of a stepwise multidisciplinary intervention for challenging behavior in advanced dementia: a cluster randomized controlled trial.

    NARCIS (Netherlands)

    Pieper, M.J.C.; Francke, A.L.; Steen, J.T. van der; Scherder, E.J.A.; Twisk, J.W.R.; Kovach, C.R.; Achterberg, W.P.

    2016-01-01

    Objectives: To assess whether implementation of a stepwise multicomponent intervention (STA OP!) is effective in reducing challenging behavior and depression in nursing home residents with advanced dementia. Design: Cluster randomized controlled trial. Setting: Twenty-one clusters (single independe

  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.

  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. Cluster randomized trials utilizing primary care electronic health records : methodological issues in design, conduct, and analysis (eCRT Study)

    NARCIS (Netherlands)

    Gulliford, Martin C; van Staa, Tjeerd P; McDermott, Lisa; McCann, Gerard; Charlton, Judith; Dregan, Alex

    2014-01-01

    BACKGROUND: There is growing interest in conducting clinical and cluster randomized trials through electronic health records. This paper reports on the methodological issues identified during the implementation of two cluster randomized trials using the electronic health records of the Clinical Prac

  5. 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…

  6. User participation in implementation

    DEFF Research Database (Denmark)

    Fleron, Benedicte; Rasmussen, Rasmus; Simonsen, Jesper;

    2012-01-01

    Systems development has been claimed to benefit from user participation, yet user participation in implementation activities may be more common and is a growing focus of participatory-design work. We investigate the effect of the extensive user participation in the implementation of a clinical...... system by empirically analyzing how management, participating staff, and non-participating staff view the implementation process with respect to areas that have previously been linked to user participation such as system quality, emergent interactions, and psychological buy-in. The participating staff...... experienced more uncertainty and frustration than management and non-participating staff, especially concerning how to run an implementation process and how to understand and utilize the configuration possibilities of the system. This suggests that user participation in implementation introduces a need...

  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. 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

  9. 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

  10. Quality assurance in clinical trials.

    NARCIS (Netherlands)

    Ottevanger, P.B.; Therasse, P.; Veld, C.J.H. van de; Bernier, J.; Krieken, J.H.J.M. van; Grol, R.P.T.M.; Mulder, P.H.M. de

    2003-01-01

    From the literature that was initially searched by electronic databases using the keywords quality, quality control and quality assurance in combination with clinical trials, surgery, pathology, radiotherapy, chemotherapy and data management, a comprehensive review is given on what quality assurance

  11. 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.

  12. 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

  13. SAE: an R package for early stopping rules in clinical trials.

    Science.gov (United States)

    Bascoul-Mollevi, C; Laplanche, A; Le Deley, M C; Kramar, A

    2011-11-01

    In the case of an unexpected high frequency of serious adverse events (SAE), statistical methods are needed to help in the decision making process as to continuation of accrual to the trial. This paper describes an R package, named SAE that implements a method recently developed by defining stopping rules after each observed SAE. The package function control for excessive toxicity either during the trial at the observation of each SAE (function SAE) or during the planning phase of a clinical trial (function DESIGN). This description and the package documentation are complementary to help the users to apply the method. The main difficulty in the implementation of the method is the choice of a priori parameters. Data from an ongoing clinical trial are presented as an example to improve the understanding and the use of the package.

  14. 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...

  15. Design of clinical trials in acute kidney injury: a report from an NIDDK workshop--prevention trials.

    Science.gov (United States)

    Okusa, Mark D; Molitoris, Bruce A; Palevsky, Paul M; Chinchilli, Vernon M; Liu, Kathleen D; Cheung, Alfred K; Weisbord, Steven D; Faubel, Sarah; Kellum, John A; Wald, Ron; Chertow, Glenn M; Levin, Adeera; Waikar, Sushrut S; Murray, Patrick T; Parikh, Chirag R; Shaw, Andrew D; Go, Alan S; Chawla, Lakhmir S; Kaufman, James S; Devarajan, Prasad; Toto, Robert M; Hsu, Chi-yuan; Greene, Tom H; Mehta, Ravindra L; Stokes, John B; Thompson, Aliza M; Thompson, B Taylor; Westenfelder, Christof S; Tumlin, James A; Warnock, David G; Shah, Sudhir V; Xie, Yining; Duggan, Emily G; Kimmel, Paul L; Star, Robert A

    2012-05-01

    AKI is an important clinical problem that has become increasingly more common. Mortality rates associated with AKI remain high despite advances in supportive care. Patients surviving AKI have increased long-term mortality and appear to be at increased risk of developing CKD and progressing to ESRD. No proven effective pharmacologic therapies are currently available for the prevention or treatment of AKI. Advances in addressing this unmet need will require the development of novel therapeutic agents based on precise understanding of key pathophysiological events and the implementation of well designed clinical trials. To address this need, the National Institute of Diabetes and Digestive and Kidney Diseases sponsored the "Clinical Trials in Acute Kidney Injury: Current Opportunities and Barriers" workshop in December 2010. The event brought together representatives from academia, industry, the National Institutes of Health, and the US Food and Drug Administration. We report the discussions of workgroups that developed outlines of clinical trials for the prevention of AKI in two patient populations: patients undergoing elective surgery who are at risk for or who develop AKI, and patients who are at risk for contrast-induced AKI. In both of these populations, primary prevention or secondary therapy can be delivered at an optimal time relative to kidney injury. The workgroups detailed primary and secondary endpoints for studies in these groups, and explored the use of adaptive clinical trial designs for trials of novel preventive strategies to improve outcomes of patients with AKI.

  16. 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.

  17. Reduction of diabetes risk in routine clinical practice: are physical activity and nutrition interventions feasible and are the outcomes from reference trials replicable? A systematic review and meta-analysis

    Directory of Open Access Journals (Sweden)

    Morrell Stephen L

    2010-10-01

    Full Text Available Abstract Background The clinical effectiveness of intensive lifestyle interventions in preventing or delaying diabetes in people at high risk has been established from randomised trials of structured, intensive interventions conducted in several countries over the past two decades. The challenge is to translate them into routine clinical settings. The objective of this review is to determine whether lifestyle interventions delivered to high-risk adult patients in routine clinical care settings are feasible and effective in achieving reductions in risk factors for diabetes. Methods Data sources: MEDLINE (PubMed, EMBASE, CINAHL, The Cochrane Library, Google Scholar, and grey literature were searched for English-language articles published from January 1990 to August 2009. The reference lists of all articles collected were checked to ensure that no relevant suitable studies were missed. Study selection: We included RCTs, before/after evaluations, cohort studies with or without a control group and interrupted time series analyses of lifestyle interventions with the stated aim of diabetes risk reduction or diabetes prevention, conducted in routine clinical settings and delivered by healthcare providers such as family physicians, practice nurses, allied health personnel, or other healthcare staff associated with a health service. Outcomes of interest were weight loss, reduction in waist circumference, improvement of impaired fasting glucose or oral glucose tolerance test (OGTT results, improvements in fat and fibre intakes, increased level of engagement in physical activity and reduction in diabetes incidence. Results Twelve from 41 potentially relevant studies were included in the review. Four studies were suitable for meta-analysis. A significant positive effect of the interventions on weight was reported by all study types. The meta-analysis showed that lifestyle interventions achieved weight and waist circumference reductions after one year

  18. 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…

  19. 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...

  20. 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.

  1. MONA Implementation Secrets

    DEFF Research Database (Denmark)

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

    2002-01-01

    a 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......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...

  2. The opportunities and challenges of pragmatic point-of-care randomised trials using routinely collected electronic records: evaluations of two exemplar trials.

    Science.gov (United States)

    van Staa, Tjeerd-Pieter; Dyson, Lisa; McCann, Gerard; Padmanabhan, Shivani; Belatri, Rabah; Goldacre, Ben; Cassell, Jackie; Pirmohamed, Munir; Torgerson, David; Ronaldson, Sarah; Adamson, Joy; Taweel, Adel; Delaney, Brendan; Mahmood, Samhar; Baracaia, Simona; Round, Thomas; Fox, Robin; Hunter, Tommy; Gulliford, Martin; Smeeth, Liam

    2014-01-01

    BACKGROUND Pragmatic trials compare the effects of different decisions in usual clinical practice. OBJECTIVES To develop and evaluate methods to implement simple pragmatic trials using routinely collected electronic health records (EHRs) and recruiting patients at the point of care; to identify the barriers and facilitators for general practitioners (GPs) and patients and the experiences of trial participants. DESIGN Two exemplar randomised trials (Retropro and eLung) with qualitative evaluations. SETTING Four hundred and fifty-nine English and Scottish general practices contributing EHRs to a research database, of which 17 participated in the trials. PARTICIPANTS Retropro aimed to recruit 300 patients with hypercholesterolaemia and high cardiovascular risk and eLung aimed to recruit 150 patients with a chronic obstructive pulmonary disease exacerbation. INTERVENTIONS Retropro randomised between simvastatin and atorvastatin and eLung between immediate antibiotics and deferred or non-use. eLung recruited during an unscheduled consultation using EHR flagging. MAIN OUTCOME MEASURE Successful trial completion with implementation of information technology (IT) system for flagging and data processing and documentation of operational and scientific experiences. DATA SOURCES EHR research database. RESULTS The governance approval process took over 3 years. A total of 58.8% of the practices (n = 270) expressed interest in participating. The number of interested practices dropped substantially with each stage of the governance process. In Retropro, 6.5% of the practices (n = 30) were eventually approved and 3.7% (n = 17) recruited patients; in eLung, these numbers were 6.8% (n = 31) and 1.3% (n = 6) respectively. Retropro successfully completed recruitment (301 patients) whereas eLung recruited 31 patients. Retropro recruited 20.6% of all statin starters in recruiting practices and 1.1% in the EHR database; the comparable numbers for eLung were 32.3% and 0

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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

  12. Development and implementation of PROgmatic

    DEFF Research Database (Denmark)

    Cramon, Per; Rasmussen, Ase Krogh; Bonnema, Steen Joop;

    2014-01-01

    these tasks. A combination of generic applications and custom coding was applied to develop an integrated system that met the required needs. PROgmatic features include secure web-based data entry; electronic case report forms (eCRFs); central participant registration and randomisation; automated emails......BACKGROUND: Many clinical trials are conducted as explanatory trials, but the applicability of results from explanatory trials to clinical practice may be questioned. Pragmatic trials elucidate both benefits and harms of an intervention under conditions close to daily clinical practice. We have...

  13. Design of clinical trials in AKI: a report from an NIDDK workshop. Trials of patients with sepsis and in selected hospital settings.

    Science.gov (United States)

    Molitoris, Bruce A; Okusa, Mark D; Palevsky, Paul M; Chawla, Lakhmir S; Kaufman, James S; Devarajan, Prasad; Toto, Robert M; Hsu, Chi-yuan; Greene, Tom H; Faubel, Sarah G; Kellum, John A; Wald, Ron; Chertow, Glenn M; Levin, Adeera; Waikar, Sushrut S; Murray, Patrick T; Parikh, Chirag R; Shaw, Andrew D; Go, Alan S; Chinchilli, Vernon M; Liu, Kathleen D; Cheung, Alfred K; Weisbord, Steven D; Mehta, Ravindra L; Stokes, John B; Thompson, Aliza M; Thompson, B Taylor; Westenfelder, Christof S; Tumlin, James A; Warnock, David G; Shah, Sudhir V; Xie, Yining; Duggan, Emily G; Kimmel, Paul L; Star, Robert A

    2012-05-01

    AKI remains an important clinical problem, with a high mortality rate, increasing incidence, and no Food and Drug Administration-approved therapeutics. Advances in addressing this clinical need require approaches for rapid diagnosis and stratification of injury, development of therapeutic agents based on precise understanding of key pathophysiological events, and implementation of well designed clinical trials. In the near future, AKI biomarkers may facilitate trial design. To address these issues, the National Institute of Diabetes and Digestive and Kidney Diseases sponsored a meeting, "Clinical Trials in Acute Kidney Injury: Current Opportunities and Barriers," in December of 2010 that brought together academic investigators, industry partners, and representatives from the National Institutes of Health and the Food and Drug Administration. Important issues in the design of clinical trials for interventions in AKI in patients with sepsis or AKI in the setting of critical illness after surgery or trauma were discussed. The sepsis working group discussed use of severity of illness scores and focus on patients with specific etiologies to enhance homogeneity of trial participants. The group also discussed endpoints congruent with those endpoints used in critical care studies. The second workgroup emphasized difficulties in obtaining consent before admission and collaboration among interdisciplinary healthcare groups. Despite the difficult trial design issues, these clinical situations represent a clinical opportunity because of the high event rates, severity of AKI, and poor outcomes. The groups considered trial design issues and discussed advantages and disadvantages of several short- and long-term primary endpoints in these patients.

  14. 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

  15. 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......, in particular with respect to collaboration with the trial sponsor and to analytic pitfalls. The advantages of creating screening databases in conjunction with a given clinical trial are described; and finally, the potential for posttrial database studies to become a platform for training young scientists...

  16. 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

  17. 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…

  18. 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...

  19. 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

  20. 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

  1. 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

  2. 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.

  3. 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

  4. 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.)

  5. 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.

  6. 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

  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. 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

  9. EPBD implementation in Denmark

    DEFF Research Database (Denmark)

    Wittchen, Kim Bjarne; Thomsen, Kirsten Engelund; Malmsteen, Margit;

    2013-01-01

    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 ...

  10. Implementering af evidensbaseret praksis

    DEFF Research Database (Denmark)

    Scheel, Linda Schumann; Tewes, Marianne; Petersen, Preben Ulrich

    2015-01-01

    Projektet omhandler implementering af den kliniske retningslinje om identifikation, forebyggelse og behandling af delirium – i denne sammenhæng relateret til hjertepatienter. Projektet foregår på to hospitaler i Hjertecentret på Rigshospitalet, et intensivt afsnit og et sengeafsnit, i tæt...

  11. Implementing Bilingual Pattern Practice

    Science.gov (United States)

    Scheffler, Pawel

    2016-01-01

    This article describes how semi-communicative bilingual drills were implemented in a four-month course in pedagogical English for a group of ten Polish adult learners. When the course was over, the learners were asked to evaluate the procedure by filling in a questionnaire. The learners expressed overwhelming approval for bilingual drills in terms…

  12. 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.

  13. EPBD implementation in Denmark

    DEFF Research Database (Denmark)

    Wittchen, Kim Bjarne; Thomsen, Kirsten Engelund; Malmsteen, Margit;

    2013-01-01

    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...... control mechanisms and information campaigns....

  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 all...

  15. Implementering af evidensbaseret praksis

    DEFF Research Database (Denmark)

    Scheel, Linda Schumann; Hansen, Ida Rode

    2014-01-01

    Projektet omhandler implementering af den kliniske retningslinje om identifikation, forebyggelse og behandling af delirium – i denne sammenhæng relateret til hjertepatienter. Projektet foregår på to hospitaler i Hjertecentret på Rigshospitalet, et intensivt afsnit og et sengeafsnit, i tæt...

  16. MONA Implementation Secrets

    DEFF Research Database (Denmark)

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

    2001-01-01

    a 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...

  17. 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...

  18. 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)

  19. The Best Bypass Surgery Trial

    DEFF Research Database (Denmark)

    Møller, Christian H; Jensen, Birte Østergaard; Gluud, Christian;

    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...

  20. 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.

  1. Pre-referral rectal artesunate in severe malaria: flawed trial

    Directory of Open Access Journals (Sweden)

    Premji Zulfiqarali G

    2011-08-01

    -indicated stratified or multi-variate analysis was not done; many improper subgroups were analyzed in a post-hoc fashion; the analysis and reporting metric was deficient. There are concerns relating to patient welfare at some centers. Exclusion of many cases from data analysis compromised external validity. A bias-controlled reanalysis of available data does not lend support to the conclusions drawn by the authors. Conclusions This trial has numerous serious deficiencies in design, implementation, and methods of data analysis. Interpretation and manner of reporting are wanting, and the applicability of the findings is unclear. The trial conduct could have been improved to better protect patient welfare. The totality of these problems make it a flawed study whose conclusions remain subject to appreciable doubt.

  2. Anesthesia information management system implementation: a practical guide.

    Science.gov (United States)

    Muravchick, Stanley; Caldwell, James E; Epstein, Richard H; Galati, Maria; Levy, Warren J; O'Reilly, Michael; Plagenhoef, Jeffrey S; Rehman, Mohamed; Reich, David L; Vigoda, Michael M

    2008-11-01

    Anesthesia Information Management Systems (AIMS) display and archive perioperative physiological data and patient information. Although currently in limited use, the potential benefits of an AIMS with regard to enhancement of patient safety, clinical effectiveness and quality improvement, charge capture and professional fee billing, regulatory compliance, and anesthesia outcomes research are great. The processes and precautions appropriate for AIMS selection, installation, and implementation are complex, however, and have been learned at each site by trial and error. This collaborative effort summarizes essential considerations for successful AIMS implementation, including product evaluation, assessment of information technology needs, resource availability, leadership roles, and training. PMID:18931218

  3. 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

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

    Directory of Open Access Journals (Sweden)

    Ong Bie

    2010-10-01

    Full Text Available 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.

  5. 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.

  6. 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...

  7. 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 ...

  8. 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.

  9. 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...

  10. 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...

  11. 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

  12. 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...

  13. 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 discussed....

  14. The challenge of implementation

    DEFF Research Database (Denmark)

    Andersen, Karen Heide Hauge

    2015-01-01

    Reaching the students in innovation and entrepreneurship courses is hard, when the courses are a requirement but not included in the main project of the curriculum. It is a major paradox for lecturers, who have never participated in and cannot see the relevance of such course, to implement...... these concepts in daily teaching, as it is strongly encouraged by policy makers and educations. This paper aims to discuss how lecturers experience the challenge of teaching their own discipline while being imposed to embrace and promote innovation and entrepreneurship teaching. Through a single study case...... of the paper: which factors influence the degree of implementation of innovation and entrepreneurship in the individual lecturers’ daily teaching? The paper questions the common approach taken by higher educational institutions whereby lecturers are urged to teach innovation and entrepreneurship with minor...

  15. 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.

  16. Caching Patterns and Implementation

    Directory of Open Access Journals (Sweden)

    Octavian Paul ROTARU

    2006-01-01

    Full Text Available 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 pattern provides method of expensive resources reacquisition circumvention. Primed Cache pattern is applied in situations in which the set of required resources, or at least a part of it, can be predicted, while Demand Cache pattern is applied whenever the resources set required cannot be predicted or is unfeasible to be buffered.The advantages and disadvantages of all the caching patterns presented are also discussed, and the lessons learned are applied in the implementation of the pattern-based flexible caching solution proposed.

  17. RF multipole implementation

    CERN Document Server

    Latina, A

    2012-01-01

    The electromagnetic radio-frequency (RF) field of accelerating structures and crab-cavities can exhibit transverse field components due to asymmetries in the azimuthal direction of the element geometry. Tracking simulations must be performed to evaluate the impact of such transverse RF deflections on the beam dynamics. In an ultra-relativistic regime where the Panofsky-Wenzel theorem is applicable, these RF deflections can be modeled via a multipolar expansion of the generating RF field similarly to what is done with static magnetic elements. The element implementing such RF multipolar fields has been called RF multipole. In this note we present an analytical formulation of a thin RF multipole Hamiltonian, and we explicitly calculate the RF kick and the elements of its first- and second- order transfer matrices. Also, we present the implementation of the corresponding code in MAD-X, plus some tests of tracking, simplecticity, consistency, and reflected maps that we successfully applied to verify the correctne...

  18. 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.

  19. 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

  20. 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...

  1. 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.

  2. 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...

  3. 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 ...

  4. 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.

  5. 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)

  6. 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.

  7. National differences in requirements for ethical and competent authority approval for a multinational vaccine trial under the EU directive 2001/20/EC

    NARCIS (Netherlands)

    van Doorn, Eva; Hak, Eelko; Wilffert, Bob

    2015-01-01

    Obtaining approval for a multinational vaccine trial from an ethics committee and the national competent authority of different Member States of the European Union (EU) is challenging under clinical trial Directive 2001/20/EC because of the differences in the implementation of the directive in natio

  8. 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…

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

    NARCIS (Netherlands)

    Verbakel, N.J.; Langelaan, M.; Verheij, T.J.M.; Wagner, C.; Zwart, D.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 was

  10. Training Head Start Teachers to Conduct Trial-Based Functional Analysis of Challenging Behavior

    Science.gov (United States)

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

    2015-01-01

    Trial-based functional analysis (TBFA) is a procedure for experimentally identifying the function of challenging behavior within applied settings. The purpose of this study was to examine the effects of a TBFA teacher-training package in the context of two Head Start centers implementing programwide positive behavior support (PWPBS). Four Head…

  11. Comparing the Effectiveness of Error-Correction Strategies in Discrete Trial Training

    Science.gov (United States)

    Turan, Michelle K.; Moroz, Lianne; Croteau, Natalie Paquet

    2012-01-01

    Error-correction strategies are essential considerations for behavior analysts implementing discrete trial training with children with autism. The research literature, however, is still lacking in the number of studies that compare and evaluate error-correction procedures. The purpose of this study was to compare two error-correction strategies:…

  12. Modified Constraint-Induced Therapy for Children with Hemiplegic Cerebral Palsy: A Randomized Trial

    Science.gov (United States)

    Wallen, Margaret; Ziviani, Jenny; Naylor, Olivia; Evans, Ruth; Novak, Iona; Herbert, Robert D.

    2011-01-01

    Aim: Conventional constraint-based therapies are intensive and demanding to implement, particularly for children. Modified forms of constraint-based therapies that are family-centred may be more acceptable and feasible for families of children with cerebral palsy (CP)-but require rigorous evaluation using randomized trials. The aim of this study…

  13. 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…

  14. Efficient Delivery of Investigational Antibacterial Agents via Sustainable Clinical Trial Networks

    NARCIS (Netherlands)

    McDonnell, Anthony; Rex, John H; Goossens, Herman; Bonten, Marc; Fowler, Vance G; Dane, Aaron

    2016-01-01

    The economics of antibiotics can be improved by infectious diseases-specific clinical trial networks. While developers would still need to implement an independent phase 1 program as well as studies focused on highly resistant pathogens, standardized procedures in a network focused on usual drug res

  15. 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

  16. Accrual to Cancer Clinical Trials

    LENUS (Irish Health Repository)

    Kelly, C

    2016-07-01

    Accrual to cancer clinical trials (CCT) is imperative to safeguard continued improvement in cancer outcomes. A retrospective chart review was performed of patients (n=140) starting a new anti-cancer agent in a north Dublin cancer centre. This review was performed over a four-month period, beginning in November 2015. Only 29% (n=41) had a CCT option. The overall accrual rate to CCT was 5% (n=7), which is comparable to internationally reported figures. The main reasons for failure to recruit to CCT included the lack of a CCT option for cancer type (n=30, 23%), stage (n=25, 19%), and line of treatment (n=23, 17%). Over the last decade, the rate of accrual to CCTs has in fact doubled and the number of trials open to recruitment has tripled. Ongoing governmental and philanthropic support is necessary to continue this trend to further expand CCT patient options with a target accrual rate of 10%.

  17. Bayesian hierarchical modeling for detecting safety signals in clinical trials.

    Science.gov (United States)

    Xia, H Amy; Ma, Haijun; Carlin, Bradley P

    2011-09-01

    Detection of safety signals from clinical trial adverse event data is critical in drug development, but carries a challenging statistical multiplicity problem. Bayesian hierarchical mixture modeling is appealing for its ability to borrow strength across subgroups in the data, as well as moderate extreme findings most likely due merely to chance. We implement such a model for subject incidence (Berry and Berry, 2004 ) using a binomial likelihood, and extend it to subject-year adjusted incidence rate estimation under a Poisson likelihood. We use simulation to choose a signal detection threshold, and illustrate some effective graphics for displaying the flagged signals.

  18. 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...

  19. 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.

  20. The Egyptian clinical trials’ registry profile: Analysis of three trial registries (International Clinical Trials Registry Platform, Pan-African Clinical Trials Registry and clinicaltrials.gov

    Directory of Open Access Journals (Sweden)

    Ahmed A. Zeeneldin

    2016-01-01

    Full Text Available Registering clinical trials (CTs in public domains enhances transparency, increases trust in research, improves participation and safeguards against publication bias. This work was done to study the profile of clinical research in Egypt in three CT registries with different scopes: the WHO International CT Registry Platform (ICTRP, the continental Pan-African CT Registry (PACTR and the US clinicaltrials.gov (CTGR. In March 2014, ICTRP, PACTR and CTGR were searched for clinical studies conducted in Egypt. It was found that the number of studies conducted in Egypt (percentage was 686 (0.30% in ICTRP, 56 (11.3% in PACTR and 548 (0.34% in CTGR. Most studies were performed in universities and sponsored by university/organization, industry or individual researchers. Inclusion of adults from both genders predominated. The median number of participants per study in the three registries ranged between 63 and 155. The conditions researched differed among the three registries and study purpose was mostly treatment followed by prevention. Endpoints were mostly efficacy followed by safety. Observational:Interventional studies (i.e. clinical trials represented 15.5%:84.5% in ICTRP, 0%:100% in PACTR and 16.4%:83.6% in CTGR. Most interventions were drugs or procedures. Observational studies were mostly prospective and cohort studies. Most CTs were phase 3 and tested drugs or procedures. Parallel group assignment and random allocation predominated. Blinding was implemented in many of trials and was mostly double-blind. We conclude that CTs from Egypt in trial registries are apparently low and do not accurately reflect clinical research conducted in Egypt or its potential. Development of an Egyptian CT registry is eagerly needed. Registering all Egyptian CTs in public domains is highly recommended.

  1. 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.

  2. 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...

  3. 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

  4. 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.

  5. -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...

  6. 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.

  7. 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

  8. 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......, and can be generalized to studying other networked technologies...

  9. 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

  10. Clinical Trials in Peripheral Vascular Disease: Pipeline and Trial Designs: An Evaluation of the ClinicalTrials.gov Database

    Science.gov (United States)

    Subherwal, Sumeet; Patel, Manesh R.; Chiswell, Karen; Tidemann-Miller, Beth A.; Jones, W. Schuyler; Conte, Michael S.; White, Christopher J.; Bhatt, Deepak L.; Laird, John R.; Hiatt, William R.; Tasneem, Asba; Califf, Robert M.

    2014-01-01

    Background Tremendous advances have occurred in therapies for peripheral vascular disease (PVD); however, until recently it has not been possible to examine the entire clinical trial portfolio of studies for treatment of PVD (both arterial and venous disease). Methods and Results We examined interventional trials registered in ClinicalTrials.gov from October 2007 through September 2010 (n=40,970) and identified 676 (1.7%) PVD trials (n=493 arterial only, n=170 venous only, n=13 both arterial and venous). Most arterial studies investigated lower extremity peripheral artery disease and acute stroke (35% and 24%, respectively), while most venous studies examined deep vein thrombosis/pulmonary embolus prevention (42%) or venous ulceration (25%). A placebo-controlled trial design was used in 27% of the PVD trials, and 4% of the PVD trials excluded patients aged >65 years. Enrollment in at least 1 US site decreased from 51% in 2007 to 41% of trials in 2010. Compared with non-cardiology disciplines, PVD trials were more likely to be double-blinded, investigate use of devices and procedures, and have industry sponsorship and assumed funding source, and less likely to investigate drug and behavioral therapies. Geographic access to PVD clinical trials within the United States is limited to primarily large metropolitan areas. Conclusions PVD studies represent a small group of trials registered in ClinicalTrials.gov, despite the high prevalence of vascular disease in the general population. This low number, compounded by the decreasing number of PVD trials in the United States, is concerning and may limit the ability to inform current clinical practice of patients with PVD. PMID:25239436

  11. 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…

  12. Methods for analyzing cost effectiveness data from cluster randomized trials

    Directory of Open Access Journals (Sweden)

    Clark Allan

    2007-09-01

    Full Text Available Abstract Background Measurement of individuals' costs and outcomes in randomized trials allows uncertainty about cost effectiveness to be quantified. Uncertainty is expressed as probabilities that an intervention is cost effective, and confidence intervals of incremental cost effectiveness ratios. Randomizing clusters instead of individuals tends to increase uncertainty but such data are often analysed incorrectly in published studies. Methods We used data from a cluster randomized trial to demonstrate five appropriate analytic methods: 1 joint modeling of costs and effects with two-stage non-parametric bootstrap sampling of clusters then individuals, 2 joint modeling of costs and effects with Bayesian hierarchical models and 3 linear regression of net benefits at different willingness to pay levels using a least squares regression with Huber-White robust adjustment of errors, b a least squares hierarchical model and c a Bayesian hierarchical model. Results All five methods produced similar results, with greater uncertainty than if cluster randomization was not accounted for. Conclusion Cost effectiveness analyses alongside cluster randomized trials need to account for study design. Several theoretically coherent methods can be implemented with common statistical software.

  13. Making randomised trials more efficient: report of the first meeting to discuss the Trial Forge platform.

    Science.gov (United States)

    Treweek, Shaun; Altman, Doug G; Bower, Peter; Campbell, Marion; Chalmers, Iain; Cotton, Seonaidh; Craig, Peter; Crosby, David; Davidson, Peter; Devane, Declan; Duley, Lelia; Dunn, Janet; Elbourne, Diana; Farrell, Barbara; Gamble, Carrol; Gillies, Katie; Hood, Kerry; Lang, Trudie; Littleford, Roberta; Loudon, Kirsty; McDonald, Alison; McPherson, Gladys; Nelson, Annmarie; Norrie, John; Ramsay, Craig; Sandercock, Peter; Shanahan, Daniel R; Summerskill, William; Sydes, Matt; Williamson, Paula; Clarke, Mike

    2015-06-05

    Randomised trials are at the heart of evidence-based healthcare, but the methods and infrastructure for conducting these sometimes complex studies are largely evidence free. Trial Forge ( www.trialforge.org ) is an initiative that aims to increase the evidence base for trial decision making and, in doing so, to improve trial efficiency.This paper summarises a one-day workshop held in Edinburgh on 10 July 2014 to discuss Trial Forge and how to advance this initiative. We first outline the problem of inefficiency in randomised trials and go on to describe Trial Forge. We present participants' views on the processes in the life of a randomised trial that should be covered by Trial Forge.General support existed at the workshop for the Trial Forge approach to increase the evidence base for making randomised trial decisions and for improving trial efficiency. Agreed upon key processes included choosing the right research question; logistical planning for delivery, training of staff, recruitment, and retention; data management and dissemination; and close down. The process of linking to existing initiatives where possible was considered crucial. Trial Forge will not be a guideline or a checklist but a 'go to' website for research on randomised trials methods, with a linked programme of applied methodology research, coupled to an effective evidence-dissemination process. Moreover, it will support an informal network of interested trialists who meet virtually (online) and occasionally in person to build capacity and knowledge in the design and conduct of efficient randomised trials.Some of the resources invested in randomised trials are wasted because of limited evidence upon which to base many aspects of design, conduct, analysis, and reporting of clinical trials. Trial Forge will help to address this lack of evidence.

  14. Training Issues in ERP Implementations

    OpenAIRE

    Iuliana DOROBAT; 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...

  15. 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...

  16. 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

  17. 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...

  18. 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...

  19. Time-related trends in variability of cIMT changes in statin trials.

    Science.gov (United States)

    Davidson, Michael H; Tomassini, Joanne E; Jensen, Erin; Neff, David; Polis, Adam B; Tershakovec, Andrew M

    2016-03-01

    This brief article provides complementary data supporting the results reported in "Changing Characteristics of Statin-related cIMT Trials from 1988 to 2006" [1]. That article described time-related trends in baseline factors and study characteristics that may have influenced the variability of carotid intima media thickness (cIMT) endpoints (mean of mean and maximum common carotid artery [CCA]/cIMT) in published statin trials. In this brief report, additional details for the studies included in the analysis, and further supporting data, including mean of the maximum CCA/cIMT changes and subgroup data (mean and maximum CCA/cIMT) are provided. For the analysis, study-level data was extracted from 17 statin cIMT trials conducted during 1988-2006, selected on the basis of having at least one statin monotherapy arm in the absence of mixed therapy, and baseline- and study-end values for mean mean and mean maximum CCA/cIMT endpoints. The baseline mean CCA/cIMT, maximum mean CCA/cIMT and LDL-C levels, and annualized cIMT changes were estimated for the overall studies, those conducted before/after 2000, and in risk-based subgroups. Interestingly, all 8 studies conducted before 2000 were significant for cIMT change in which patients did not receive prior LLT; whereas after 2000, the results were more variable and in 4 of 6 trials that did not show a significant cIMT change, patients had received prior treatment. Baseline mean maximum cIMT and LDL-C levels, and annualized changes in studies conducted before 2000 were higher than those conducted after 2000, similar to the results reported in the original article for the mean mean cIMT endpoint. These findings were consistent across study populations of patients with CHD risk versus those without, and in studies with greater LDL-C reductions and with thickened baseline cIMT at study entry for both mean and maximum cIMT changes. Taken together, these results are consistent with trends in recent years toward greater use of lipid

  20. Time-related trends in variability of cIMT changes in statin trials

    Directory of Open Access Journals (Sweden)

    Michael H. Davidson

    2016-03-01

    Full Text Available This brief article provides complementary data supporting the results reported in “Changing Characteristics of Statin-related cIMT Trials from 1988 to 2006” [1]. That article described time-related trends in baseline factors and study characteristics that may have influenced the variability of carotid intima media thickness (cIMT endpoints (mean of mean and maximum common carotid artery [CCA]/cIMT in published statin trials. In this brief report, additional details for the studies included in the analysis, and further supporting data, including mean of the maximum CCA/cIMT changes and subgroup data (mean and maximum CCA/cIMT are provided. For the analysis, study-level data was extracted from 17 statin cIMT trials conducted during 1988–2006, selected on the basis of having at least one statin monotherapy arm in the absence of mixed therapy, and baseline- and study-end values for mean mean and mean maximum CCA/cIMT endpoints. The baseline mean CCA/cIMT, maximum mean CCA/cIMT and LDL-C levels, and annualized cIMT changes were estimated for the overall studies, those conducted before/after 2000, and in risk-based subgroups. Interestingly, all 8 studies conducted before 2000 were significant for cIMT change in which patients did not receive prior LLT; whereas after 2000, the results were more variable and in 4 of 6 trials that did not show a significant cIMT change, patients had received prior treatment. Baseline mean maximum cIMT and LDL-C levels, and annualized changes in studies conducted before 2000 were higher than those conducted after 2000, similar to the results reported in the original article for the mean mean cIMT endpoint. These findings were consistent across study populations of patients with CHD risk versus those without, and in studies with greater LDL-C reductions and with thickened baseline cIMT at study entry for both mean and maximum cIMT changes. Taken together, these results are consistent with trends in recent years

  1. Time-related trends in variability of cIMT changes in statin trials.

    Science.gov (United States)

    Davidson, Michael H; Tomassini, Joanne E; Jensen, Erin; Neff, David; Polis, Adam B; Tershakovec, Andrew M

    2016-03-01

    This brief article provides complementary data supporting the results reported in "Changing Characteristics of Statin-related cIMT Trials from 1988 to 2006" [1]. That article described time-related trends in baseline factors and study characteristics that may have influenced the variability of carotid intima media thickness (cIMT) endpoints (mean of mean and maximum common carotid artery [CCA]/cIMT) in published statin trials. In this brief report, additional details for the studies included in the analysis, and further supporting data, including mean of the maximum CCA/cIMT changes and subgroup data (mean and maximum CCA/cIMT) are provided. For the analysis, study-level data was extracted from 17 statin cIMT trials conducted during 1988-2006, selected on the basis of having at least one statin monotherapy arm in the absence of mixed therapy, and baseline- and study-end values for mean mean and mean maximum CCA/cIMT endpoints. The baseline mean CCA/cIMT, maximum mean CCA/cIMT and LDL-C levels, and annualized cIMT changes were estimated for the overall studies, those conducted before/after 2000, and in risk-based subgroups. Interestingly, all 8 studies conducted before 2000 were significant for cIMT change in which patients did not receive prior LLT; whereas after 2000, the results were more variable and in 4 of 6 trials that did not show a significant cIMT change, patients had received prior treatment. Baseline mean maximum cIMT and LDL-C levels, and annualized changes in studies conducted before 2000 were higher than those conducted after 2000, similar to the results reported in the original article for the mean mean cIMT endpoint. These findings were consistent across study populations of patients with CHD risk versus those without, and in studies with greater LDL-C reductions and with thickened baseline cIMT at study entry for both mean and maximum cIMT changes. Taken together, these results are consistent with trends in recent years toward greater use of lipid

  2. 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.

  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

    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.

  5. 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.

  6. 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.

  7. 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

  8. Implementing public employment policy

    DEFF Research Database (Denmark)

    Larsen, Flemming; Bredgaard, Thomas

    happens to public employment policies when they are contracted out to various non-public (for-profit and non-profit) agencies. The data consist of in-depth interviews with key respondents in the three countries, observations at service delivery agencies, and desk studies of existing research.......? The main objective of this article is to focus on the relationship between NPM structures (specifically contracting out) and shifts in the substance of policy (specifically employment policies). We propose that changes in management are capable of supporting policy changes by means of new implementation...... structures (and often do – whether intentionally or not). However, management reforms tend to be dominated by “technical” discourses on their alleged effectiveness and efficiency, whereas their consequences for policy content tend to be neglected or given limited attention. Even when NPM reforms do support...

  9. 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.

  10. Moving the implementation line

    DEFF Research Database (Denmark)

    Carugati, Andrea; Giangreco, A.; Sebastiano, A.

    2011-01-01

    embraces the call to develop evolving systems in continuously emergent organizations and to identify the main factors that can lead to continuous system development—a continuously moving implementation line—from within the organization. In doing so, we draw on a longitudinal analysis of the experience...... of a typical Western nursing home that, in the past 12 years, has aimed to internally develop a healthcare provision and management system to support its evolving needs. Our analysis shows that four factors enable this concurrent change: (1) the internal appreciation of change, (2) the external appreciation...... of change, (3) enlightened management, and (4) emancipated employees. By controlling for the latter two factors, managers of long-term care centers can motivate employees to contribute to the development of the system over long periods and limit undesired behaviors with information technology (IT). From...

  11. 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....

  12. Contributions of the European trials (European randomized screening group) in computed tomography lung cancer screening.

    Science.gov (United States)

    Heuvelmans, Marjolein A; Vliegenthart, Rozemarijn; Oudkerk, Matthijs

    2015-03-01

    Lung cancer is the leading cause of cancer-related death worldwide. In 2011, the largest lung cancer screening trial worldwide, the US National Lung Screening Trial, published a 20% decrease in lung cancer-specific mortality in the computed tomography (CT)-screened group, compared with the group screened by chest x-ray. On the basis of this trial, different US guidelines recently have recommended CT lung cancer screening. However, several questions regarding the implementation of lung cancer screening need to be answered. In Europe, several lung cancer screening trials are ongoing. It is planned to pool the results of the lung cancer screening trials in European randomized lung cancer CT screening (EUCT). By pooling of the data, EUCT hopes to be able to provide additional information for the discussion of some important issues regarding the implementation of lung cancer screening by low-dose CT, including: the determination of the optimal screen population, the comparison between a volume-based and diameter-based nodule management protocol, and the determination of optimal screen intervals.

  13. 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

  14. PrEP implementation in the Asia-Pacific region: opportunities, implementation and barriers

    Directory of Open Access Journals (Sweden)

    Iryna Zablotska

    2016-10-01

    Full Text Available Introduction: HIV epidemics in the Asia-Pacific region are concentrated among men who have sex with men (MSM and other key populations. Pre-exposure prophylaxis (PrEP is an effective HIV prevention intervention and could be a potential game changer in the region. We discuss the progress towards PrEP implementation in the Asia-Pacific region, including opportunities and barriers. Discussion: Awareness about PrEP in the Asia-Pacific is still low and so are its levels of use. A high proportion of MSM who are aware of PrEP are willing to use it. Key PrEP implementation barriers include poor knowledge about PrEP, limited access to PrEP, weak or non-existent HIV prevention programmes for MSM and other key populations, high cost of PrEP, stigma and discrimination against key populations and restrictive laws in some countries. Only several clinical trials, demonstration projects and a few larger-scale implementation studies have been implemented so far in Thailand and Australia. However, novel approaches to PrEP implementation have emerged: researcher-, facility- and community-led models of care, with PrEP services for fee and for free. The WHO consolidated guidelines on HIV testing, treatment and prevention call for an expanded access to PrEP worldwide and have provided guidance on PrEP implementation in the region. Some countries like Australia have released national PrEP guidelines. There are growing community leadership and consultation processes to initiate PrEP implementation in Asia and the Pacific. Conclusions: Countries of the Asia-Pacific region will benefit from adding PrEP to their HIV prevention packages, but for many this is a critical step that requires resourcing. Having an impact on the HIV epidemic requires investment. The next years should see the region transitioning from limited PrEP implementation projects to growing access to PrEP and expansion of HIV prevention programmes.

  15. PrEP implementation in the Asia-Pacific region: opportunities, implementation and barriers

    Science.gov (United States)

    Zablotska, Iryna; Grulich, Andrew E; Phanuphak, Nittaya; Anand, Tarandeep; Janyam, Surang; Poonkasetwattana, Midnight; Baggaley, Rachel; van Griensven, Frits; Lo, Ying-Ru

    2016-01-01

    Introduction HIV epidemics in the Asia-Pacific region are concentrated among men who have sex with men (MSM) and other key populations. Pre-exposure prophylaxis (PrEP) is an effective HIV prevention intervention and could be a potential game changer in the region. We discuss the progress towards PrEP implementation in the Asia-Pacific region, including opportunities and barriers. Discussion Awareness about PrEP in the Asia-Pacific is still low and so are its levels of use. A high proportion of MSM who are aware of PrEP are willing to use it. Key PrEP implementation barriers include poor knowledge about PrEP, limited access to PrEP, weak or non-existent HIV prevention programmes for MSM and other key populations, high cost of PrEP, stigma and discrimination against key populations and restrictive laws in some countries. Only several clinical trials, demonstration projects and a few larger-scale implementation studies have been implemented so far in Thailand and Australia. However, novel approaches to PrEP implementation have emerged: researcher-, facility- and community-led models of care, with PrEP services for fee and for free. The WHO consolidated guidelines on HIV testing, treatment and prevention call for an expanded access to PrEP worldwide and have provided guidance on PrEP implementation in the region. Some countries like Australia have released national PrEP guidelines. There are growing community leadership and consultation processes to initiate PrEP implementation in Asia and the Pacific. Conclusions Countries of the Asia-Pacific region will benefit from adding PrEP to their HIV prevention packages, but for many this is a critical step that requires resourcing. Having an impact on the HIV epidemic requires investment. The next years should see the region transitioning from limited PrEP implementation projects to growing access to PrEP and expansion of HIV prevention programmes. PMID:27760688

  16. Algorithms that eliminate the effects of calibration artefact and trial-imposed offsets of Masimo oximeter in BOOST-NZ trial.

    Science.gov (United States)

    Zahari, Marina; Lee, Dominic Savio; Darlow, Brian Alexander

    2016-10-01

    The displayed readings of Masimo pulse oximeters used in the Benefits Of Oxygen Saturation Targeting (BOOST) II and related trials in very preterm babies were influenced by trial-imposed offsets and an artefact in the calibration software. A study was undertaken to implement new algorithms that eliminate the effects of offsets and artefact. In the BOOST-New Zealand trial, oxygen saturations were averaged and stored every 10 s up to 36 weeks' post-menstrual age. Two-hundred and fifty-seven of 340 babies enrolled in the trial had at least two weeks of stored data. Oxygen saturation distribution patterns corresponding with a +3 % or -3 % offset in the 85-95 % range were identified together with that due to the calibration artefact. Algorithms involving linear and quadratic interpolations were developed, implemented on each baby of the dataset and validated using the data of a UK preterm baby, as recorded from Masimo oximeters with the original software and a non-offset Siemens oximeter. Saturation distributions obtained were compared for both groups. There were a flat region at saturations 85-87 % and a peak at 96 % from the lower saturation target oximeters, and at 93-95 and 84 % respectively from the higher saturation target oximeters. The algorithms lowered the peaks and redistributed the accumulated frequencies to the flat regions and artefact at 87-90 %. The resulting distributions were very close to those obtained from the Siemens oximeter. The artefact and offsets of the Masimo oximeter's software had been addressed to determine the true saturation readings through the use of novel algorithms. The implementation would enable New Zealand data be included in the meta-analysis of BOOST II trials, and be used in neonatal oxygen studies.

  17. 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

  18. 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.

  19. 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.

  20. Intervention trial of previous nonattender invitation for breast screening.

    Science.gov (United States)

    Fleming, Padraic; Mooney, Therese; Wilson, Linda; Fitzpatrick, Patricia

    2016-11-01

    BreastCheck, the National Breast Screening Programme in the Republic of Ireland, invites women aged between 50 and 64 years biennially. A pilot intervention trial of invitation for screening of women not attending the previous appointment [previous nonattender (PNA)] was carried out that aimed at maximizing the efficiency of resources in terms of radiographer workload and scheduled appointment slots. The trial was conducted during screening round 5 at two of the regional units. The intervention arm implemented an alternative process for inviting PNA women, in which they were sent a letter inviting them to phone their screening unit to make an appointment at a convenient date/time. The control arm continued usual practice - that is, all PNA women were sent a single invitation letter with a scheduled appointment slot at a predetermined date/time. In the intervention arm, fewer PNAs took up their appointments (15.5%) compared with the control arm (18.3%; P<0.001). Uptake among PNAs fell in both arms between screening rounds 4 and 5 (intervention arm: 22.0% OSR 4, 15.5% OSR 5; control arm: 21.4% OSR 4, 18.3% OSR 5). There was a significant increase in mobile unit screening days saved because of the intervention and a significant improvement in the percentage of women reinvited for screening within 27 months in the intervention arm (85.5%). PNA recall and cancer detection rates were significantly higher compared with the general screened population. This trial showed an improvement in the efficiency of resource use. However, there was a higher cancer detection rate in PNA women. This trial provides important evidence for invitation policy for screening. PMID:26642321

  1. OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of rehabilitation interventions for osteoarthritis.

    Science.gov (United States)

    Fitzgerald, G K; Hinman, R S; Zeni, J; Risberg, M A; Snyder-Mackler, L; Bennell, K L

    2015-05-01

    A Task Force of the Osteoarthritis Research Society International (OARSI) has previously published a set of guidelines for the conduct of clinical trials in osteoarthritis (OA) of the hip and knee. Limited material available on clinical trials of rehabilitation in people with OA has prompted OARSI to establish a separate Task Force to elaborate guidelines encompassing special issues relating to rehabilitation of OA. The Task Force identified three main categories of rehabilitation clinical trials. The categories included non-operative rehabilitation trials, post-operative rehabilitation trials, and trials examining the effectiveness of devices (e.g., assistive devices, bracing, physical agents, electrical stimulation, etc.) that are used in rehabilitation of people with OA. In addition, the Task Force identified two main categories of outcomes in rehabilitation clinical trials, which include outcomes related to symptoms and function, and outcomes related to disease modification. The guidelines for rehabilitation clinical trials provided in this report encompass these main categories. The report provides guidelines for conducting and reporting on randomized clinical trials. The topics include considerations for entering patients into trials, issues related to conducting trials, considerations for selecting outcome measures, and recommendations for statistical analyses and reporting of results. The focus of the report is on rehabilitation trials for hip, knee and hand OA, however, we believe the content is broad enough that it could be applied to rehabilitation trials for other regions as well.

  2. 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

  3. Internet trials: participant experiences and perspectives

    OpenAIRE

    Mathieu Erin; Barratt Alexandra; Carter Stacy M; Jamtvedt Gro

    2012-01-01

    Abstract Background Use of the Internet to conduct randomised controlled trials is increasing, and provides potential to increase equity of access to medical research, increase the generalisability of trial results and decrease the costs involved in conducting large scale trials. Several studies have compared response rates, completeness of data, and reliability of surveys using the Internet and traditional methods, but very little is known about participants’ attitudes towards Internet-based...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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].

  9. Random assignment in clinical trials: issues in planning (Infant Health and Development Program).

    Science.gov (United States)

    Kraemer, H C; Fendt, K H

    1990-01-01

    Various options available for the randomization of subjects into groups in a clinical trial are discussed, emphasizing the issues of logistics given less focus in more mathematical treatments. We discuss advantages and disadvantages of total randomization, of Zelen-type randomization procedures, of Efron-type procedures vs more classical blocking procedures to control the balance between groups, and of Simon-Pocock-type procedures vs more classical stratification for controlling possible biases in prognostic factors. Finally, we discuss issues related to choice and implementation of randomization procedures. The discussion is illustrated with the processes of decision-making in a national collaborative randomized clinical trial, the Infant Health and Development Program.

  10. Generalized Likelihood Ratio Statistics and Uncertainty Adjustments in Efficient Adaptive Design of Clinical Trials

    CERN Document Server

    Bartroff, Jay

    2011-01-01

    A new approach to adaptive design of clinical trials is proposed in a general multiparameter exponential family setting, based on generalized likelihood ratio statistics and optimal sequential testing theory. These designs are easy to implement, maintain the prescribed Type I error probability, and are asymptotically efficient. Practical issues involved in clinical trials allowing mid-course adaptation and the large literature on this subject are discussed, and comparisons between the proposed and existing designs are presented in extensive simulation studies of their finite-sample performance, measured in terms of the expected sample size and power functions.

  11. 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.

  12. 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...... 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...

  13. 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...... 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...

  14. 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.

  15. 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

  16. Use of the experience sampling method in the context of clinical trials

    Science.gov (United States)

    Verhagen, Simone J W; Hasmi, Laila; Drukker, Marjan; van Os, J; Delespaul, Philippe A E G

    2016-01-01

    Objective The experience sampling method (ESM) is a structured diary technique to appraise subjective experiences in daily life. It is applied in psychiatric patients, as well as in patients with somatic illness. Despite the potential of ESM assessment, the improved logistics and its increased administration in research, its use in clinical trials remains limited. This paper introduces ESM for clinical trials in psychiatry and beyond. Methods ESM is an ecologically valid method that yields a comprehensive view of an individual's daily life. It allows the assessment of various constructs (eg, quality of life, psychopathology) and psychological mechanisms (eg, stress-sensitivity, coping). These constructs are difficult to assess using cross-sectional questionnaires. ESM can be applied in treatment monitoring, as an ecological momentary intervention, in clinical trials, or in single case clinical trials. Technological advances (eg, smartphone applications) make its implementation easier. Results Advantages of ESM are highlighted and disadvantages are discussed. Furthermore, the ecological nature of ESM data and its consequences are explored, including the potential pitfalls of ambiguously formulated research questions and the specificities of ESM in statistical analyses. The last section focuses on ESM in relation to clinical trials and discusses its future use in optimising clinical decision-making. Conclusions ESM can be a valuable asset in clinical trial research and should be used more often to study the benefits of treatment in psychiatry and somatic health. PMID:27443678

  17. Overcoming Challenges in Conducting Clinical Trials in Minority Populations: Identifying and Testing What Works

    Directory of Open Access Journals (Sweden)

    Romuladus E. Azuine, DrPH, RN

    2015-03-01

    Full Text Available Participation in clinical trials is one of the greatest gifts that humanity can give to the fields of medicine and public health. Clinical trials are central in public health’s mission to advance drug discovery. The enrollment and retention of participants, especially minority populations, is one of the most practical challenges of successfully implementing a clinical trial. In spite of these challenges, there are many reasons why a broader public participation in clinical trials is critical. The ability to generalize the scientific findings and the principles of equity, justice, and beneficence require an equitable distribution of the risks, benefits, and burdens of research for all classes and groups of people. A new methodology article published in this journal presents a promising framework for addressing minority recruitment and retention using what is known and using it innovatively to address a difficult problem facing clinical trials and public health. The innovative application of what is known in addressing a challenging problem, as this article presents, is worth the reading of all those interested in scientifically rigorous and ethically sound clinical trials that substantially comprise of diverse populations.

  18. 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.

  19. 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

  20. 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

  1. 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.

  2. 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

  3. 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...

  4. 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

  5. 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.

  6. 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.

  7. Children in clinical trials: survey on the current situation in paediatric university clinics in Germany

    Directory of Open Access Journals (Sweden)

    Hundt, Ferdinand

    2008-03-01

    Full Text Available Many prescribed treatments for children have not been adequately tested in children, sometimes resulting in harmful treatments being given and beneficial treatments being withheld. In the absence of specific trial-based data in children, results of studies in adults are extrapolated, which is often inappropriate because children have different range of diseases and metabolize medications differently. Trials in children are more challenging than those in adults and the pool of eligible children entering trials is often small. Children must have at last the same rights as adults in relation to receiving treatment with medicinal products that have been fully tested. The need for more studies to obtain paediatric information for medicines used in children is now a matter of consensus on a global basis and is considered a public health priority. Therfore a survey was performed in university hospitals in Germany targeting the current and future situation of children in clinical trials. The questionnaire of this survey was sent to 68 paediatric departments in 31 university clinics in Germany with a respond rate of 27% with respect to 18 returned questionnaires. With regard to new laws, guidelines and strong governmental support and funding an increasing number of clinical trials is expected. Surprisingly, the number of trials in the paediatric population remains unchanged within a period of 4 years (2005-2008. Added to the surveys performed within the pharmaceutical industry from Heinrich and Hark the number of trials in children remains unchanged even within a period of 9 years (2000-2008. The efforts undertaken by the government regarding funding and supporting KKS (Coordinating Centers for Clinical Trials and affiliated PAED-Net (Pediatric Network on Medication Development and Testing in Children and Adolescents at KKS appear to be insufficient. Beginning of this year the legal framework with the urgent expected “Paediatric Regulation” was

  8. User Participation in Pilot Implementation

    DEFF Research Database (Denmark)

    Torkilsheyggi, Arnvør Martinsdóttir á; Hertzum, Morten

    2014-01-01

    Pilot implementations provide users with real-work experiences of how a system will affect their daily work before the design of the system is finalized. On the basis of a pilot implementation of a system for coordinating the transport of patients by hospital porters, we investigate pilot...... implementation as a method for participatory design. We find that to foster participation and learning about user needs a pilot implementation must create a space for reflecting on use, in addition to the space for using the pilot system. The space for reflection must also exist during the activities preparing...... the use of the pilot system because the porters and nurses learned about their needs throughout the pilot implementation, not just during use. Finally, we discuss how the scope and duration of a pilot implementation influence the conditions for participation....

  9. National Lung Screening Trial Results: Fast Facts

    Science.gov (United States)

    On November 4, 2010, the NLST reported initial trial results, showing 20 percent fewer lung cancer deaths among trial participants screened with low-dose helical CT (also known as spiral CT) compared to those who got screened with chest X-rays.

  10. Alien wavelength modeling tool and field trial

    DEFF Research Database (Denmark)

    Sambo, N.; Sgambelluri, A.; Secondini, M.;

    2015-01-01

    A modeling tool is presented for pre-FEC BER estimation of PM-QPSK alien wavelength signals. A field trial is demonstrated and used as validation of the tool's correctness. A very close correspondence between the performance of the field trial and the one predicted by the modeling tool has been...

  11. Controversy, Trials, and Crime--Oh My!

    Science.gov (United States)

    Rott, Kim

    2006-01-01

    Teenagers' innate interest with the justice system is one of the reasons that so many high school literary classics teem with criminals, controversial issues, and trials. Novels such as "To Kill a Mockingbird," "A Separate Peace," "The Crucible," and "Twelve Angry Men" feature high-impact trials. In the author's desire to tap into this interest,…

  12. Homo Economicus and the Salem Witch Trials.

    Science.gov (United States)

    Mixon, Franklin G., Jr.

    2000-01-01

    Provides background information on the Salem Witch Trials (Salem, Massachusetts) and the medical explanation of the young village girls' behavior in Salem called ergotism (bread poisoning). Presents an economic interpretation of those trials, stating that the ministers employed religious beliefs about witchcraft to maintain their churchs' monopoly…

  13. International Clinical Trials Registry Platform (ICTRP)

    Institute of Scientific and Technical Information of China (English)

    2011-01-01

    @@ Introduction The mission of the WHO Intemational Clinical Trials Registry Platform is to ensure that a complete view of research is accessible to all those involved in health care decision making.This will improve research transparency and will ultimately strengthen tha validity and value of the scientific evidence base.The registration of all interventional trials is a scientific, ethical and moral responsibility.

  14. Blinded trials taken to the test

    DEFF Research Database (Denmark)

    Hróbjartsson, A; Forfang, E; Haahr, M T;

    2007-01-01

    Blinding can reduce bias in randomized clinical trials, but blinding procedures may be unsuccessful. Our aim was to assess how often randomized clinical trials test the success of blinding, the methods involved and how often blinding is reported as being successful....

  15. The Child and Adolescent Psychiatry Trials Network

    Science.gov (United States)

    March, John S.; Silva, Susan G.; Compton, Scott; Anthony, Ginger; DeVeaugh-Geiss, Joseph; Califf, Robert; Krishnan, Ranga

    2004-01-01

    Objective: The current generation of clinical trials in pediatric psychiatry often fails to maximize clinical utility for practicing clinicians, thereby diluting its impact. Method: To attain maximum clinical relevance and acceptability, the Child and Adolescent Psychiatry Trials Network (CAPTN) will transport to pediatric psychiatry the practical…

  16. 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...

  17. 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...

  18. 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...

  19. Implementation Method of Stable Model

    Directory of Open Access Journals (Sweden)

    Shasha Wu

    2008-01-01

    Full Text Available Software Stability Modeling (SSM is a promising software development methodology based on object-oriented programming to achieve model level stability and reusability. Among the three critical categories of objects proposed by SSM, the business objects play a critical role in connecting the stable problem essentials (enduringbusiness themes and the unstable object implementations (industry objects. The business objects are especially difficult to implement and often raise confusion in the implementation because of their unique characteristics: externally stable and internally unstable. The implementation and code level stability is not the major concern. How to implement the objects in a stable model through object-oriented programming without losing its stability is a big challenge in the real software development. In this paper, we propose new methods to realize the business objects in the implementation of stable model. We also rephrase the definition of the business objects from the implementation perspective, in hope the new description can help software developers to adopt and implement stable models more easily. Finally, we describe the implementation of a stable model for a balloon rental resource management scope to illustrate the advantages of the proposed method.

  20. Ethics of clinical trials in Nigeria.

    Science.gov (United States)

    Okonta, Patrick I

    2014-05-01

    The conduct of clinical trials for the development and licensing of drugs is a very important aspect of healthcare. Drug research, development and promotion have grown to a multi-billion dollar global business. Like all areas of human endeavour involving generation and control of huge financial resources, it could be subject to deviant behaviour, sharp business practices and unethical practices. The main objective of this review is to highlight potential ethical challenges in the conduct of clinical trials in Nigeria and outline ways in which these can be avoided. Current international and national regulatory and ethical guidelines are reviewed to illustrate the requirements for ethical conduct of clinical trials. Past experiences of unethical conduct of clinical trials especially in developing countries along with the increasing globalisation of research makes it imperative that all players should be aware of the ethical challenges in clinical trials and the benchmarks for ethical conduct of clinical research in Nigeria.