Impact of Air Temperature on London Ambulance Call-Out Incidents and Response Times

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Marliyyah A. Mahmood

2017-08-01

Full Text Available Ambulance services are in operation around the world and yet, until recently, ambulance data has only been used for operational purposes rather than for assessing public health. Ambulance call-out data offers new and valuable (near real-time information that can be used to assess the impact of environmental conditions, such as temperature, upon human health. A detailed analysis of London ambulance data at a selection of dates between 2003 and 2015 is presented and compared to London temperature data. In London, the speed of ambulance response begins to suffer when the mean daily air temperature drops below 2 °C or rises above 20 °C. This is explained largely by the increased number of calls past these threshold temperatures. The baseline relationships established in this work will inform the prediction of likely changes in ambulance demand (and illness types that may be caused by seasonal temperature changes and the increased frequency and intensity of extreme/severe weather events, exacerbated by climate change, in the future.

Randomised controlled pragmatic clinical trial evaluating the effectiveness of a discharge follow-up phone call on 30-day hospital readmissions: balancing pragmatic and explanatory design considerations

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Yiadom, Maame Yaa A B; Domenico, Henry; Byrne, Daniel; Hasselblad, Michele Marie; Gatto, Cheryl L; Kripalani, Sunil; Choma, Neesha; Tucker, Sarah; Wang, Li; Bhatia, Monisha C; Morrison, Johnston; Harrell, Frank E; Hartert, Tina; Bernard, Gordon

2018-01-01

Introduction Hospital readmissions within 30 days are a healthcare quality problem associated with increased costs and poor health outcomes. Identifying interventions to improve patients’ successful transition from inpatient to outpatient care is a continued challenge. Methods and analysis This is a single-centre pragmatic randomised and controlled clinical trial examining the effectiveness of a discharge follow-up phone call to reduce 30-day inpatient readmissions. Our primary endpoint is inpatient readmission within 30 days of hospital discharge censored for death analysed with an intention-to-treat approach. Secondary endpoints included observation status readmission within 30 days, time to readmission, all-cause emergency department revisits within 30 days, patient satisfaction (measured as mean Hospital Consumer Assessment of Healthcare Providers and Systems scores) and 30-day mortality. Exploratory endpoints include the need for assistance with discharge plan implementation among those randomised to the intervention arm and reached by the study nurse, and the number of call attempts to achieve successful intervention delivery. Consistent with the Learning Healthcare System model for clinical research, timeliness is a critical quality for studies to most effectively inform hospital clinical practice. We are challenged to apply pragmatic design elements in order to maintain a high-quality practicable study providing timely results. This type of prospective pragmatic trial empowers the advancement of hospital-wide evidence-based practice directly affecting patients. Ethics and dissemination Study results will inform the structure, objective and function of future iterations of the hospital’s discharge follow-up phone call programme and be submitted for publication in the literature. Trial registration number NCT03050918; Pre-results. PMID:29444787

Modeling the impact of a carbon tax: A trial analysis for Washington State

International Nuclear Information System (INIS)

Mori, Keibun

2012-01-01

In recent years, energy policy makers have proposed a carbon tax as an economy-wide policy tool to curb greenhouse gas (GHG) emissions. The quantification of its impact on GHG emissions has relied on an energy-economy model, whose complexity often makes it difficult to comprehend how it simulates the interaction of a carbon tax and energy demand. This study therefore aims at developing an alternative model called the Carbon Tax Analysis Model (C-TAM). The elasticity-based approach used in C-TAM is less sophisticated than an equilibrium-based approach used in an energy-economy model, but C-TAM is designed to maximize its predictive capabilities by using a wide range of elasticities for each sector and fuel use, accounting for likely changes in fuel mix for electricity generation, and addressing the model's sensitivity to elasticity estimates with Monte Carlo simulation. The trial analysis in this study evaluates a potential carbon tax in Washington State, suggesting a carbon tax at US$30 per metric ton of CO 2 (tCO 2 ) lowers GHG emissions by 8.4% from the business-as-usual (BAU) scenario in 2035. The study concludes that C-TAM can provide meaningful policy implications by forecasting detailed impact on revenues and energy demand for each sector and fuel use. - Highlights: ► An elasticity-based model is developed to forecast the impact of a carbon tax. ► This model can show detailed impacts on each sector and fuel use. ► Extensive literature review and sensitivity analyses cover the model's weakness. ► A carbon tax is effective in curbing greenhouse gas emissions in Washington State. ► A carbon tax is however more effective if implemented nationwide.

Impact of Protected Sleep Period for Internal Medicine Interns on Overnight Call on Depression, Burnout, and Empathy

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Shea, Judy A.; Bellini, Lisa M.; Dinges, David F.; Curtis, Meredith L.; Tao, Yuanyuan; Zhu, Jingsan; Small, Dylan S.; Basner, Mathias; Norton, Laurie; Novak, Cristina; Dine, C. Jessica; Rosen, Ilene M.; Volpp, Kevin G.

2014-01-01

Background Patient safety and sleep experts advocate a protected sleep period for residents. Objective We examined whether interns scheduled for a protected sleep period during overnight call would have better end-of-rotation assessments of burnout, depression, and empathy scores compared with interns without protected sleep periods and whether the amount of sleep obtained during on call predicted end-of-rotation assessments. Methods We conducted a randomized, controlled trial with internal medicine interns at the Philadelphia Veterans Affairs Medical Center (PVAMC) and the Hospital of the University of Pennsylvania (HUP) in academic year 2009–2010. Four-week blocks were randomly assigned to either overnight call permitted under the 2003 duty hour standards or a protected sleep period from 12:30 am to 5:30 am. Participants wore wrist actigraphs. At the beginning and end of the rotations, they completed the Beck Depression Inventory (BDI-II), Maslach Burnout Inventory (MBI-HSS), and Interpersonal Reactivity Index (IRI). Results A total of 106 interns participated. There were no significant differences between groups in end-of-rotation BDI-II, MBI-HSS, or IRI scores at either location (P > .05). Amount of sleep while on call significantly predicted lower MBI-Emotional Exhaustion (P < .003), MBI-Depersonalization (P < .003), and IRI-Personal Distress (P < .006) at PVAMC, and higher IRI-Perspective Taking (P < .008) at HUP. Conclusions A protected sleep period produced few consistent improvements in depression, burnout, or empathy, although depression was already low at baseline. Possibly the amount of protected time was too small to affect these emotional states or sleep may not be directly related to these scores. PMID:24949128

Call center performance with direct response advertising

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M. Kiygi Calli (Meltem); M. Weverbergh (Marcel); Ph.H.B.F. Franses (Philip Hans)

2017-01-01

textabstractThis study investigates the manpower planning and the performance of a national call center dealing with car repairs and on the road interventions. We model the impact of advertising on the capacity required. The starting point is a forecasting model for the incoming calls, where we take

Impact of Using CALL on Iranian EFL Learners' Vocabulary Knowledge

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Yunus, Melor Md; Salehi, Hadi; Amini, Mahdi

2016-01-01

Computer Assisted Language Learning (CALL) integration in EFL contexts has intensified noticeably in recent years. This integration might be in different ways and for different purposes such as vocabulary acquisition, grammar learning, phonology, writing skills, etc. More explicitly, this study is an attempt to explore the effect of using CALL on…

The effect of the publication of a major clinical trial in a high impact journal on clinical practise: the ORACLE Trial experience.

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Kenyon, Sara; Taylor, David J

2002-12-01

To estimate the short term effect of the publication of a major clinical trial on clinical practise. Questionnaire survey of clinical practise. UK. All maternity units in the UK. A self-administered questionnaire completed by lead consultants on delivery suite of maternity units. Changes in antibiotic prescription. Within six months of publication, approximately 50% of maternity units had changed their guidelines for the care of women with preterm prelabour rupture of the fetal membranes. Publication of a major clinical trial does impact on clinical practise but the impact is heterogeneous in terms of time and consistency.

Impact of clinical trials on neurosurgical practice: an assessment of case volume.

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Simon, Scott D; Koyama, Tatsuki; Zacharia, Brad E; Schirmer, Clemens M; Cheng, Joseph S

2015-04-01

To evaluate the effect of important trials on the practice of neurosurgery. We hypothesized that evidence from trials addressing the management of intracranial aneurysms (International Subarachnoid Aneurysm Trial [ISAT]) and nontraumatic intracerebral hemorrhages (Surgical Trial in Intracerebral Hemorrhage [STICH]) and vertebral augmentation for osteoporotic vertebral body fractures had a significant impact on the frequency of the corresponding neurosurgical procedures. A Medicare administrative database was queried for corresponding Common Procedural Terminology codes and units billed per calendar year. The effects of ISAT and STICH were evaluated using a generalized linear model. The effect of the vertebral augmentation study was evaluated using a t test. After publication of ISAT in 2002, the rate of increase in proportion of cerebral aneurysms that were treated with embolization (Common Procedural Terminology code 61624) per year increased from 3.9% to 5.5% (P = 0.01). After publication of STICH in 2005, the number of craniotomies performed for intracerebral hematoma decreased from 2341 in 2002 to 1646 in 2011 (P = 0.03). After 2 publications in 2009, performance of vertebral augmentation decreased from a high of 99,961 in 2009 per year to 77,108 in 2013 (P = 0.002). Randomized clinical trials remain the gold standard in the medical community to demonstrate efficacy, but their true impact relies on rapid and extensive assimilation into everyday medical practice. However, the described methodology establishes a temporal relationship only and does not prove causation. Nonetheless, trends in procedural volume suggest that the results of these select randomized clinical trials had a significant effect on neurosurgical practice affecting Medicare patients within an interval of a few years. Copyright © 2015 Elsevier Inc. All rights reserved.

Staffing to Maximize Profit for Call Centers with Impatient and Repeat-Calling Customers

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Jun Gong

2015-01-01

Full Text Available Motivated by call center practice, we study the optimal staffing of many-server queues with impatient and repeat-calling customers. A call center is modeled as an M/M/s+M queue, which is developed to a behavioral queuing model in which customers come and go based on their satisfaction with waiting time. We explicitly take into account customer repeat behavior, which implies that satisfied customers might return and have an impact on the arrival rate. Optimality is defined as the number of agents that maximize revenues net of staffing costs, and we account for the characteristic that revenues are a direct function of staffing. Finally, we use numerical experiments to make certain comparisons with traditional models that do not consider customer repeat behavior. Furthermore, we indicate how managers might allocate staffing optimally with various customer behavior mechanisms.

Effectiveness of newspaper advertising for patient recruitment into a clinical trial.

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Hapca, Adrian; Jennings, Claudine G; Wei, Li; Wilson, Adam; MacDonald, Thomas M; Mackenzie, Isla S

2014-06-01

To measure the impact of newspaper advertising across Scotland on patient interest, and subsequent recruitment into the Standard Care vs. Celecoxib Outcome Trial (SCOT), a clinical trial investigating the cardiovascular safety of non-steroidal anti-inflammatory drugs in patients with osteoarthritis or rheumatoid arthritis. Newspaper advertisements about the SCOT trial were placed sequentially in regional and national Scottish newspapers. The number of phone calls as a result of exposure to the advertisements and ongoing study recruitment rates were recorded before, during and after the advertising campaign. To enroll in SCOT individuals had to be registered with a participating GP practice. The total cost for the advertising campaign was £46 250 and 320 phone calls were received as a result of individuals responding to the newspaper advertisements. One hundred and seventy-two individuals were identified as possibly suitable to be included in the study. However only 36 were registered at participating GP practices, 17 completed a screening visit and 15 finally were randomized into the study. The average cost per respondent individual was £144 and the average cost per randomized patient was £3083. Analysis of recruitment rate trends showed that there was no impact of the newspaper advertising campaign on increasing recruitment into SCOT. Advertisements placed in local and national newspapers were not an effective recruitment strategy for the SCOT trial. The advertisements attracted relatively small numbers of respondents, many of whom did not meet study inclusion criteria or were not registered at a participating GP practice. © 2013 The British Pharmacological Society.

Effectiveness of newspaper advertising for patient recruitment into a clinical trial

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Hapca, Adrian; Jennings, Claudine G; Wei, Li; Wilson, Adam; MacDonald, Thomas M; Mackenzie, Isla S

2014-01-01

Aims To measure the impact of newspaper advertising across Scotland on patient interest, and subsequent recruitment into the Standard Care vs. Celecoxib Outcome Trial (SCOT), a clinical trial investigating the cardiovascular safety of non-steroidal anti-inflammatory drugs in patients with osteoarthritis or rheumatoid arthritis. Methods Newspaper advertisements about the SCOT trial were placed sequentially in regional and national Scottish newspapers. The number of phone calls as a result of exposure to the advertisements and ongoing study recruitment rates were recorded before, during and after the advertising campaign. To enroll in SCOT individuals had to be registered with a participating GP practice. Results The total cost for the advertising campaign was £46 250 and 320 phone calls were received as a result of individuals responding to the newspaper advertisements. One hundred and seventy-two individuals were identified as possibly suitable to be included in the study. However only 36 were registered at participating GP practices, 17 completed a screening visit and 15 finally were randomized into the study. The average cost per respondent individual was £144 and the average cost per randomized patient was £3083. Analysis of recruitment rate trends showed that there was no impact of the newspaper advertising campaign on increasing recruitment into SCOT. Conclusions Advertisements placed in local and national newspapers were not an effective recruitment strategy for the SCOT trial. The advertisements attracted relatively small numbers of respondents, many of whom did not meet study inclusion criteria or were not registered at a participating GP practice. PMID:24283948

TADtool: visual parameter identification for TAD-calling algorithms.

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Kruse, Kai; Hug, Clemens B; Hernández-Rodríguez, Benjamín; Vaquerizas, Juan M

2016-10-15

Eukaryotic genomes are hierarchically organized into topologically associating domains (TADs). The computational identification of these domains and their associated properties critically depends on the choice of suitable parameters of TAD-calling algorithms. To reduce the element of trial-and-error in parameter selection, we have developed TADtool: an interactive plot to find robust TAD-calling parameters with immediate visual feedback. TADtool allows the direct export of TADs called with a chosen set of parameters for two of the most common TAD calling algorithms: directionality and insulation index. It can be used as an intuitive, standalone application or as a Python package for maximum flexibility. TADtool is available as a Python package from GitHub (https://github.com/vaquerizaslab/tadtool) or can be installed directly via PyPI, the Python package index (tadtool). kai.kruse@mpi-muenster.mpg.de, jmv@mpi-muenster.mpg.deSupplementary information: Supplementary data are available at Bioinformatics online. © The Author 2016. Published by Oxford University Press.

Call Forecasting for Inbound Call Center

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Peter Vinje

2009-01-01

Full Text Available In a scenario of inbound call center customer service, the ability to forecast calls is a key element and advantage. By forecasting the correct number of calls a company can predict staffing needs, meet service level requirements, improve customer satisfaction, and benefit from many other optimizations. This project will show how elementary statistics can be used to predict calls for a specific company, forecast the rate at which calls are increasing/decreasing, and determine if the calls may stop at some point.

Environmental constraints and call evolution in torrent-dwelling frogs.

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Goutte, Sandra; Dubois, Alain; Howard, Samuel D; Marquez, Rafael; Rowley, Jodi J L; Dehling, J Maximilian; Grandcolas, Philippe; Rongchuan, Xiong; Legendre, Frédéric

2016-04-01

Although acoustic signals are important for communication in many taxa, signal propagation is affected by environmental properties. Strong environmental constraints should drive call evolution, favoring signals with greater transmission distance and content integrity in a given calling habitat. Yet, few empirical studies have verified this prediction, possibly due to a shortcoming in habitat characterization, which is often too broad. Here we assess the potential impact of environmental constraints on the evolution of advertisement call in four groups of torrent-dwelling frogs in the family Ranidae. We reconstruct the evolution of calling site preferences, both broadly categorized and at a finer scale, onto a phylogenetic tree for 148 species with five markers (∼3600 bp). We test models of evolution for six call traits for 79 species with regard to the reconstructed history of calling site preferences and estimate their ancestral states. We find that in spite of existing morphological constraints, vocalizations of torrent-dwelling species are most probably constrained by the acoustic specificities of torrent habitats and particularly their high level of ambient noise. We also show that a fine-scale characterization of calling sites allows a better perception of the impact of environmental constraints on call evolution. © 2016 The Author(s). Evolution © 2016 The Society for the Study of Evolution.

ICT and the location of call centres: regional and local patterns

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Bruinsma, Frank; Rietveld, Piet; Beekman, Michiel

2004-01-01

One of the sectors that gained most of the boost in ICT developments is the call centres sector. The focus in this paper is on spatial diffusion patterns of call centres in the Netherlands. The number of call centres has increased rapidly in the last decade and it seems that impacts of call

Impact of new technologies on stress, attrition and well-being in emergency call centers: the NextGeneration 9-1-1 study protocol.

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Baseman, Janet; Revere, Debra; Painter, Ian; Stangenes, Scott; Lilly, Michelle; Beaton, Randal; Calhoun, Rebecca; Meischke, Hendrika

2018-05-04

Our public health emergency response system relies on the "first of the first responders"-the emergency call center workforce that handles the emergency needs of a public in distress. Call centers across the United States have been preparing for the "Next Generation 9-1-1" initiative, which will allow citizens to place 9-1-1 calls using a variety of digital technologies. The impacts of this initiative on a workforce that is already highly stressed is unknown. There is concern that these technology changes will increase stress, reduce job performance, contribute to maladaptive coping strategies, lower employee retention, or change morale in the workplace. Understanding these impacts to inform approaches for mitigating the health and performance risks associated with new technologies is crucial for ensuring the 911 system fulfills its mission of providing optimal emergency response to the public. Our project is an observational, prospective cohort study framed by the first new technology that will be implemented: text-to-911 calling. Emergency center call takers will be recruited nationwide. Data will be collected by online surveys distributed at each center before text-to-911 implementation; within the first month of implementation; and 6 months after implementation. Primary outcome measures are stress as measured by the Calgary Symptoms of Stress Index, use of sick leave, job performance, and job satisfaction. Primary analyses will use mixed effects regression models and mixed effects logistic regression models to estimate the change in outcome variables associated with text-to-911 implementation. Multiple secondary analyses will examine effects of stress on absenteeism; associations between technology attitudes and stress; effects of implementation on attitudes towards technology; and mitigating effects of job demands, job satisfaction, attitudes towards workplace technology and workplace support on change in stress. Our public health dependence on this workforce

Reducing juvenile delinquency with automated cell phone calls.

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Burraston, Bert O; Bahr, Stephen J; Cherrington, David J

2014-05-01

Using a sample of 70 juvenile probationers (39 treatment and 31 controls), we evaluated the effectiveness of a rehabilitation program that combined cognitive-behavioral training and automated phone calls. The cognitive-behavioral training contained six 90-min sessions, one per week, and the phone calls occurred twice per day for the year following treatment. Recidivism was measured by whether they were rearrested and the total number of rearrests during the 1st year. To test the impact of the phone calls, those who received phone calls were divided into high and low groups depending on whether they answered more or less than half of their phone calls. Those who completed the class and answered at least half of their phone calls were less likely to have been arrested and had fewer total arrests.

Conflicts of interest at medical journals: the influence of industry-supported randomised trials on journal impact factors and revenue - cohort study.

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Lundh, Andreas; Barbateskovic, Marija; Hróbjartsson, Asbjørn; Gøtzsche, Peter C

2010-10-26

transparency in reporting of conflict of interest is an increasingly important aspect of publication in medical journals. Publication of large industry-supported trials may generate many citations and journal income through reprint sales and thereby be a source of conflicts of interest for journals. We investigated industry-supported trials' influence on journal impact factors and revenue. we sampled six major medical journals (Annals of Internal Medicine, Archives of Internal Medicine, BMJ, JAMA, The Lancet, and New England Journal of Medicine [NEJM]). For each journal, we identified randomised trials published in 1996-1997 and 2005-2006 using PubMed, and categorized the type of financial support. Using Web of Science, we investigated citations of industry-supported trials and the influence on journal impact factors over a ten-year period. We contacted journal editors and retrieved tax information on income from industry sources. The proportion of trials with sole industry support varied between journals, from 7% in BMJ to 32% in NEJM in 2005-2006. Industry-supported trials were more frequently cited than trials with other types of support, and omitting them from the impact factor calculation decreased journal impact factors. The decrease varied considerably between journals, with 1% for BMJ to 15% for NEJM in 2007. For the two journals disclosing data, income from the sales of reprints contributed to 3% and 41% of the total income for BMJ and The Lancet in 2005-2006. publication of industry-supported trials was associated with an increase in journal impact factors. Sales of reprints may provide a substantial income. We suggest that journals disclose financial information in the same way that they require them from their authors, so that readers can assess the potential effect of different types of papers on journals' revenue and impact.

Conflicts of interest at medical journals: the influence of industry-supported randomised trials on journal impact factors and revenue - cohort study.

Directory of Open Access Journals (Sweden)

Andreas Lundh

2010-10-01

Full Text Available BACKGROUND: transparency in reporting of conflict of interest is an increasingly important aspect of publication in medical journals. Publication of large industry-supported trials may generate many citations and journal income through reprint sales and thereby be a source of conflicts of interest for journals. We investigated industry-supported trials' influence on journal impact factors and revenue. METHODS AND FINDINGS: we sampled six major medical journals (Annals of Internal Medicine, Archives of Internal Medicine, BMJ, JAMA, The Lancet, and New England Journal of Medicine [NEJM]. For each journal, we identified randomised trials published in 1996-1997 and 2005-2006 using PubMed, and categorized the type of financial support. Using Web of Science, we investigated citations of industry-supported trials and the influence on journal impact factors over a ten-year period. We contacted journal editors and retrieved tax information on income from industry sources. The proportion of trials with sole industry support varied between journals, from 7% in BMJ to 32% in NEJM in 2005-2006. Industry-supported trials were more frequently cited than trials with other types of support, and omitting them from the impact factor calculation decreased journal impact factors. The decrease varied considerably between journals, with 1% for BMJ to 15% for NEJM in 2007. For the two journals disclosing data, income from the sales of reprints contributed to 3% and 41% of the total income for BMJ and The Lancet in 2005-2006. CONCLUSIONS: publication of industry-supported trials was associated with an increase in journal impact factors. Sales of reprints may provide a substantial income. We suggest that journals disclose financial information in the same way that they require them from their authors, so that readers can assess the potential effect of different types of papers on journals' revenue and impact.

Expanding Local Cancer Clinical Trial Options: Analysis of the Economic Impact of the Midwest Cancer Alliance in Kansas.

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Gafford, J Atlee; Gurley-Calvez, Tami; Krebill, Hope; Lai, Sue Min; Christiadi; Doolittle, Gary C

2017-09-01

Patients benefit from receiving cancer treatment closer to home when possible and at high-volume regional centers when specialized care is required. The purpose of this analysis was to estimate the economic impact of retaining more patients in-state for cancer clinical trials and care, which might offset some of the costs of establishing broader cancer trial and treatment networks. Kansas Cancer Registry data were used to estimate the number of patients retained in-state for cancer care following the expansion of local cancer clinical trial options through the Midwest Cancer Alliance based at the University of Kansas Medical Center. The 2014 economic impact of this enhanced local clinical trial network was estimated in four parts: Medical spending was estimated on the basis of National Cancer Institute cost-of-care estimates. Household travel cost savings were estimated as the difference between in-state and out-of-state travel costs. Trial-related grant income was calculated from administrative records. Indirect and induced economic benefits to the state were estimated using an economic impact model. The authors estimated that the enhanced local cancer clinical trial network resulted in approximately $6.9 million in additional economic activity in the state in 2014, or $362,000 per patient retained in-state. This estimate includes $3.6 million in direct spending and $3.3 million in indirect economic activity. The enhanced trial network also resulted in 45 additional jobs. Retaining patients in-state for cancer care and clinical trial participation allows patients to remain closer to home for care and enhances the state economy.

Magnitude of effects in clinical trials published in high-impact general medical journals.

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Siontis, Konstantinos C M; Evangelou, Evangelos; Ioannidis, John P A

2011-10-01

Prestigious journals select for publication studies that are considered most important and informative. We aimed to examine whether high-impact general (HIG) medical journals systematically demonstrate more favourable results for experimental interventions compared with the rest of the literature. We scrutinized systematic reviews of the Cochrane Database (Issue 4, 2009) and meta-analyses published in four general journals (2008-09). Eligible articles included ≥1 binary outcome meta-analysis(es) pertaining to effectiveness with ≥1 clinical trial(s) published in NEJM, JAMA or Lancet. Effect sizes in trials from NEJM, JAMA or Lancet were compared with those from other trials in the same meta-analyses by deriving summary relative odds ratios (sRORs). Additional analyses examined separately early- and late-published trials in HIG journals and journal-specific effects. A total of 79 meta-analyses including 1043 clinical trials were analysed. Trials in HIG journals had similar effects to trials in other journals, when there was large-scale evidence, but showed more favourable results for experimental interventions when they were small. When HIG trials had less than 40 events, the sROR was 1.64 [95% confidence interval (95% CI): 1.23-2.18). The difference was most prominent when small early trials published in HIG journals were compared with subsequent trials [sROR 2.68 (95% CI: 1.33-5.38)]. Late-published HIG trials showed no consistent inflation of effects. The patterns did not differ beyond chance between NEJM, JAMA or Lancet. Small trials published in the most prestigious journals show more favourable effects for experimental interventions, and this is most prominent for early-published trials in such journals. No effect inflation is seen for large trials.

Gestational Weight Gain: Results from the Delta Healthy Sprouts Comparative Impact Trial

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Jessica L. Thomson

2016-01-01

Full Text Available Introduction. Delta Healthy Sprouts trial was designed to test the comparative impact of two home visiting programs on weight status, dietary intake, and health behaviors of Southern African American women and their infants. Results pertaining to the primary outcome, gestational weight gain, are reported. Methods. Participants (n=82, enrolled early in their second trimester of pregnancy, were randomly assigned to one of two treatment arms. Gestational weight gain, measured at six monthly home visits, was calculated by subtracting measured weight at each visit from self-reported prepregnancy weight. Weight gain was classified as under, within, or exceeding the Institute of Medicine recommendations based on prepregnancy body mass index. Chi-square tests and generalized linear mixed models were used to test for significant differences in percentages of participants within recommended weight gain ranges. Results. Differences in percentages of participants within the gestational weight gain guidelines were not significant between treatment arms across all visits. Conclusions. Enhancing the gestational nutrition and physical activity components of an existing home visiting program is feasible in a high risk population of primarily low income African American women. The impact of these enhancements on appropriate gestational weight gain is questionable given the more basic living needs of such women. This trial is registered with ClinicalTrials.gov NCT01746394, registered 4 December 2012.

Calling under pressure: short-finned pilot whales make social calls during deep foraging dives.

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Jensen, Frants H; Perez, Jacobo Marrero; Johnson, Mark; Soto, Natacha Aguilar; Madsen, Peter T

2011-10-22

Toothed whales rely on sound to echolocate prey and communicate with conspecifics, but little is known about how extreme pressure affects pneumatic sound production in deep-diving species with a limited air supply. The short-finned pilot whale (Globicephala macrorhynchus) is a highly social species among the deep-diving toothed whales, in which individuals socialize at the surface but leave their social group in pursuit of prey at depths of up to 1000 m. To investigate if these animals communicate acoustically at depth and test whether hydrostatic pressure affects communication signals, acoustic DTAGs logging sound, depth and orientation were attached to 12 pilot whales. Tagged whales produced tonal calls during deep foraging dives at depths of up to 800 m. Mean call output and duration decreased with depth despite the increased distance to conspecifics at the surface. This shows that the energy content of calls is lower at depths where lungs are collapsed and where the air volume available for sound generation is limited by ambient pressure. Frequency content was unaffected, providing a possible cue for group or species identification of diving whales. Social calls may be important to maintain social ties for foraging animals, but may be impacted adversely by vessel noise.

Effects of a Phone Call Intervention to Promote Adherence to Antiretroviral Therapy and Quality of Life of HIV/AIDS Patients in Baoshan, China: A Randomized Controlled Trial

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Dongsheng Huang

2013-01-01

Full Text Available Background. Suboptimal adherence to antiretroviral therapy (ART is still pervasive. The effect of using a mobile phone call intervention to improve patient adherence is currently not known. Objective. This study aims to investigate the effects of a phone call intervention on adherence to ART and quality of life (QOL of treatment-naive and treatment-experienced patients. Methods. A randomized controlled trial was conducted in the three largest public hospitals. Adherence was measured by self-completed questionnaires. QOL was assessed by the WHOQOL-HIV BREF. Outcomes were assessed at day 15, at 1, 2, and 3 months after start of treatment for treatment-naive patients and at 3 months after study enrollment for treatment-experienced patients. Results. A total of 103 treatment-naive and 93 treatment-experienced HIV/AIDS patients were consecutively recruited. Results show that a phone call intervention could maintain high self-reported adherence among both treatment-naive and treatment-experienced patients. After three months, significant QOL improvements were observed in domains of physical health (P=0.003, level of independence (P=0.018, environment (P=0.002, and spirituality/religion/personal beliefs (P=0.021 among treatment-naive patients. Conclusion. A mobile phone call intervention to patients could maintain high adherence rates although no statistically significant differences were found. A phone call could improve some domains of QOL among treatment-naive patients.

Clinical Trials

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Full Text Available ... you to explore NIH Clinical Center for patient recruitment and clinical trial information. For more information, please email the NIH Clinical Center Office of Patient Recruitment at cc-prpl@cc.nih.gov or call ...

Clinical Trials

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Full Text Available ... risk of heart disease in the first few years, and HT also increased the risk of stroke ... master plan called a protocol (PRO-to-kol). This plan explains how the trial will work. The ...

Trial Protocol: Using genotype to tailor prescribing of nicotine replacement therapy: a randomised controlled trial assessing impact of communication upon adherence

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Prevost A Toby

2010-11-01

Full Text Available Abstract Background The behavioural impact of pharmacogenomics is untested; informing smokers of genetic test results for responsiveness to smoking cessation medication may increase adherence to this medication. The objective of this trial is to estimate the impact upon adherence to nicotine replacement therapy (NRT of informing smokers that their oral dose of NRT has been tailored to a DNA analysis. Hypotheses to be tested are as follows: IAdherence to NRT is greater among smokers informed that their oral dose of NRT is tailored to an analysis of DNA (genotype, compared to one tailored to nicotine dependence questionnaire score (phenotype. II Amongst smokers who fail to quit at six months, motivation to make another quit attempt is lower when informed that their oral dose of NRT was tailored to genotype rather than phenotype. Methods/Design An open label, parallel groups randomised trial in which 630 adult smokers (smoking 10 or more cigarettes daily using National Health Service (NHS stop smoking services in primary care are randomly allocated to one of two groups: i. NRT oral dose tailored by DNA analysis (OPRM1 gene (genotype, or ii. NRT oral dose tailored by nicotine dependence questionnaire score (phenotype The primary outcome is proportion of prescribed NRT consumed in the first 28 days following an initial quit attempt, with the secondary outcome being motivation to make another quit attempt, amongst smokers not abstinent at six months. Other outcomes include adherence to NRT in the first seven days and biochemically validated smoking abstinence at six months. The primary outcome will be collected on 630 smokers allowing sufficient power to detect a 7.5% difference in mean proportion of NRT consumed using a two-tailed test at the 5% level of significance between groups. The proportion of all NRT consumed in the first four weeks of quitting will be compared between arms using an independent samples t-test and by estimating the 95

Evaluating the Motivational Impact of CALL Systems: Current Practices and Future Directions

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Bodnar, Stephen; Cucchiarini, Catia; Strik, Helmer; van Hout, Roeland

2016-01-01

A major aim of computer-assisted language learning (CALL) is to create computer environments that facilitate students' second language (L2) acquisition. To achieve this aim, CALL employs technological innovations to create novel types of language practice. Evaluations of the new practice types serve the important role of distinguishing effective…

Impact of sending email reminders of the legal requirement for posting results on ClinicalTrials.gov: cohort embedded pragmatic randomized controlled trial.

Science.gov (United States)

Maruani, Annabel; Boutron, Isabelle; Baron, Gabriel; Ravaud, Philippe

2014-09-19

To evaluate the impact of sending an email to responsible parties of completed trials that do not comply with the Food and Drug Administration Amendments Act 801 legislation, to remind them of the legal requirement to post results. Cohort embedded pragmatic randomized controlled trial. Trials registered on ClinicalTrials.gov. 190 out of 379 trials randomly selected by computer generated randomization list to receive the intervention (personalized emails structured as a survey and sent by one of us to responsible parties of the trials, indirectly reminding them of the legal requirement and potential penalties for non-compliance). The primary outcome was the proportion of results posted on ClinicalTrials.gov at three months. The secondary outcome was the proportion posted at six months. In a second step, two assessors blinded to the intervention group collected the date of the first results being received on ClinicalTrials.gov. A post hoc sensitivity analysis excluding trials wrongly included was performed. Among 379 trials included, 190 were randomized to receive the email intervention. The rate of posting of results did not differ at three months between trials with or without the intervention: 36/190 (19%) v 24/189 (13%), respectively (relative risk 1.5, 95% confidence interval 0.9 to 2.4, P=0.096) but did at six months: 46/190 (24%) v 27/189 (14%), 1.7, 1.1 to 2.6, P=0.014. In the sensitivity analysis, which excluded 48/379 trials (13%), 26/190 (14%) and 22/189 (12%), respectively, results were significant at three months (relative risk 5.1, 1.1 to 22.9, P=0.02) and at six months (4.1, 1.3 to 10.6, P=0.001). Sending email reminders about the FDA's legal requirement to post results at ClinicalTrials.gov improved significantly the posting rate at six months but not at three months.Trial registration ClinicalTrials.gov NCT01658254. © Maruani et al 2014.

How Do School-Based Prevention Programs Impact Teachers? Findings from a Randomized Trial of an Integrated Classroom Management and Social-Emotional Program.

Science.gov (United States)

Domitrovich, Celene E; Bradshaw, Catherine P; Berg, Juliette K; Pas, Elise T; Becker, Kimberly D; Musci, Rashelle; Embry, Dennis D; Ialongo, Nicholas

2016-04-01

A number of classroom-based interventions have been developed to improve social and behavioral outcomes for students, yet few studies have examined how these programs impact the teachers who are implementing them. Impacts on teachers may affect students and therefore also serve as an important proximal outcome to examine. The current study draws upon data from a school-based randomized controlled trial testing the impact of two prevention programs. In one intervention condition, teachers were trained in the classroom behavior management program, PAX Good Behavior Game (PAX GBG). In a second intervention condition, teachers were trained to use an integrated program, referred to as PATHS to PAX, of the PAX GBG and a social and emotional learning curriculum called Promoting Alternative Thinking Strategies (PATHS©). This study aimed to determine whether both interventions positively impacted teachers, with a particular interest in the teachers' own beliefs and perceptions regarding self-efficacy, burnout, and social-emotional competence. The sample included 350 K-5 teachers across 27 schools (18 schools randomized to intervention, 9 to control). Multilevel latent growth curve analyses indicated that the PATHS to PAX condition generally demonstrated the most benefits to teachers, relative to both the control and PAX GBG conditions. These findings suggest that school-based preventive interventions can have a positive impact on teachers' beliefs and perceptions, particularly when the program includes a social-emotional component. Several possible mechanisms might account for the added benefit to teachers. Additional research is needed to better understand how these programs impact teachers, as well as students.

The impact of life review on depression in older adults: a randomized controlled trial

NARCIS (Netherlands)

Pot, A.M.; Bohlmeijer, E.T.; Onrust, S.; Melenhorst, A.S.; Veerbeek, M.A.; de Vries, W.

2010-01-01

Background: We developed an indicated preventive life-review course, Looking for Meaning, based on the assumption that reminiscence styles influence coping with depressive symptoms. This study describes the impact of this course in a pragmatic randomized controlled trial. Methods: Inclusion criteria

The impact of life review on depression in older adults: a randomized controlled trial

NARCIS (Netherlands)

Pot, Anne Margriet; Bohlmeijer, Ernst Thomas; Onrust, Simone; Melenhorst, Anne-Sophie; Veerbeek, Marjolein; de Vries, Wilma

2010-01-01

Background: We developed an indicated preventive life-review course, “Looking for Meaning”, based on the assumption that reminiscence styles influence coping with depressive symptoms. This study describes the impact of this course in a pragmatic randomized controlled trial. Methods: Inclusion

Impact of a cancer clinical trials web site on discussions about trial participation: a cluster randomized trial.

Science.gov (United States)

Dear, R F; Barratt, A L; Askie, L M; Butow, P N; McGeechan, K; Crossing, S; Currow, D C; Tattersall, M H N

2012-07-01

Cancer patients want access to reliable information about currently recruiting clinical trials. Oncologists and their patients were randomly assigned to access a consumer-friendly cancer clinical trials web site [Australian Cancer Trials (ACT), www.australiancancertrials.gov.au] or to usual care in a cluster randomized controlled trial. The primary outcome, measured from audio recordings of oncologist-patient consultations, was the proportion of patients with whom participation in any clinical trial was discussed. Analysis was by intention-to-treat accounting for clustering and stratification. Thirty medical oncologists and 493 patients were recruited. Overall, 46% of consultations in the intervention group compared with 34% in the control group contained a discussion about clinical trials (P=0.08). The mean consultation length in both groups was 29 min (P=0.69). The proportion consenting to a trial was 10% in both groups (P=0.65). Patients' knowledge about randomized trials was lower in the intervention than the control group (mean score 3.0 versus 3.3, P=0.03) but decisional conflict scores were similar (mean score 42 versus 43, P=0.83). Good communication between patients and physicians is essential. Within this context, a web site such as Australian Cancer Trials may be an important tool to encourage discussion about clinical trial participation.

Risk of bias assessment of randomised controlled trials in high-impact ophthalmology journals and general medical journals: a systematic review.

Science.gov (United States)

Joksimovic, Lazar; Koucheki, Robert; Popovic, Marko; Ahmed, Yusuf; Schlenker, Matthew B; Ahmed, Iqbal Ike K

2017-10-01

Evidence-based treatments in ophthalmology are often based on the results of randomised controlled trials. Biased conclusions from randomised controlled trials may lead to inappropriate management recommendations. This systematic review investigates the prevalence of bias risk in randomised controlled trials published in high-impact ophthalmology journals and ophthalmology trials from general medical journals. Using Ovid MEDLINE, randomised controlled trials in the top 10 high-impact ophthalmology journals in 2015 were systematically identified and critically appraised for the prevalence of bias risk. Included randomised controlled trials were assessed in all domains of bias as defined by the Cochrane Collaboration. In addition, the prevalence of conflict of interest and industry sponsorship was investigated. A comparison with ophthalmology articles from high-impact general medical journals was performed. Of the 259 records that were screened from ophthalmology-specific journals, 119 trials met all inclusion criteria and were critically appraised. In total, 29.4% of domains had an unclear risk, 13.8% had a high risk and 56.8% had a low risk of bias. In comparison, ophthalmology articles from general medical journals had a lower prevalence of unclear risk (17.1%), higher prevalence of high risk (21.9%) and a higher prevalence of low risk domains (61.9%). Furthermore, 64.7% of critically appraised trials from ophthalmology-specific journals did not report any conflicts of interest, while 70.6% did not report an industry sponsor of their trial. In closing, it is essential that authors, peer reviewers and readers closely follow published risk of bias guidelines. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Tailored online cognitive behavioural therapy with or without therapist support calls to target psychological distress in adults receiving haemodialysis: A feasibility randomised controlled trial.

Science.gov (United States)

Hudson, Joanna L; Moss-Morris, Rona; Norton, Sam; Picariello, Federica; Game, David; Carroll, Amy; Spencer, Jonathan; McCrone, Paul; Hotopf, Matthew; Yardley, Lucy; Chilcot, Joseph

2017-11-01

Psychological distress is prevalent in haemodialysis (HD) patients yet access to psychotherapy remains limited. This study assessed the feasibility and acceptability of online cognitive-behavioural therapy (CBT) tailored for HD patients, with or without therapist support, for managing psychological distress. This feasibility randomised controlled trial recruited patients from a UK HD centre. Following psychological distress screens, patients with mild-moderate psychological distress (Patient Health Questionnaire PHQ-9; score: 5-19 and/or Generalised Anxiety Disorder; GAD-7 score: 5-14) who met remaining inclusion criteria were approached for consent. Consenters were individually randomised (1:1) to online-CBT or online-CBT plus three therapist support calls. Outcomes included recruitment, retention, and adherence rates. Exploratory change analyses were performed for: psychological distress, quality of life (QoL), illness perceptions, and costs. The statistician was blinded to allocation. 182 (44%) out of 410 patients approached completed psychological distress screens. 26% found screening unacceptable; a further 30% found it unfeasible. Psychological distress was detected in 101 (55%) patients, 60 of these met remaining inclusion criteria. The primary reason for ineligibility was poor computer literacy (N=17, 53%). Twenty-five patients were randomised to the supported (N=18) or unsupported arm (N=7); 92% were retained at follow-up. No differences in psychological distress or cost-effectiveness were observed. No trial adverse events occurred. Online CBT appears feasible but only for computer literate patients who identify with the label psychological distress. A definitive trial using the current methods for psychological distress screening and online care delivery is unfeasible. ClinicalTrials.gov Identifier: NCT02352870. Copyright © 2017 Elsevier Inc. All rights reserved.

Evolution of advertisement calls in African clawed frogs

Science.gov (United States)

Tobias, Martha L.; Evans, Ben J.; Kelley, Darcy B.

2014-01-01

Summary For most frogs, advertisement calls are essential for reproductive success, conveying information on species identity, male quality, sexual state and location. While the evolutionary divergence of call characters has been examined in a number of species, the relative impacts of genetic drift or natural and sexual selection remain unclear. Insights into the evolutionary trajectory of vocal signals can be gained by examining how advertisement calls vary in a phylogenetic context. Evolution by genetic drift would be supported if more closely related species express more similar songs. Conversely, a poor correlation between evolutionary history and song expression would suggest evolution shaped by natural or sexual selection. Here, we measure seven song characters in 20 described and two undescribed species of African clawed frogs (genera Xenopus and Silurana) and four populations of X. laevis. We identify three call types — click, burst and trill — that can be distinguished by click number, call rate and intensity modulation. A fourth type is biphasic, consisting of two of the above. Call types vary in complexity from the simplest, a click, to the most complex, a biphasic call. Maximum parsimony analysis of variation in call type suggests that the ancestral type was of intermediate complexity. Each call type evolved independently more than once and call type is typically not shared by closely related species. These results indicate that call type is homoplasious and has low phylogenetic signal. We conclude that the evolution of call type is not due to genetic drift, but is under selective pressure. PMID:24723737

Assessing the Impact of Homophobic Name Calling on Early Adolescent Mental Health: A Longitudinal Social Network Analysis of Competing Peer Influence Effects.

Science.gov (United States)

DeLay, Dawn; Hanish, Laura D; Zhang, Linlin; Martin, Carol Lynn

2017-05-01

The goal of the current study was to improve our understanding of why adolescence is a critical period for the consideration of declining mental health. We did this by focusing on the impact of homophobic name calling on early adolescent mental health after the transition to middle school. Because we know that homophobic name calling emerges within a dynamic peer group structure, we used longitudinal social network analysis to assess the relation between homophobic name calling, depressive symptoms, and self-esteem while simultaneously limiting bias from alternative peer socialization mechanisms. A sample of adolescents who recently transitioned to a large public middle school (N = 299; 53 % girls; M age  = 11.13 years, SD = 0.48) were assessed. Longitudinal assessments of peer relationship networks, depressive symptoms, and self-esteem were collected during the fall and spring of the academic year. The results suggest that, after accounting for the simultaneous effect of alternative peer socialization processes, adolescent experiences of homophobic name calling in the fall predict higher levels of depressive symptoms and lower levels of self-esteem over the course of the academic year. These findings provide evidence of a significant influence of homophobic name calling on adolescent mental health.

Investigating CALL in the Classroom: Situational Variables to Consider

Directory of Open Access Journals (Sweden)

Darlene Liutkus

2012-01-01

Full Text Available A new paradigm in second language pedagogy has Computer Assisted Language Learning (CALL playing a significant role. Much of the literature to-date claims that CALL can have a positive impact on students’ second language acquisition (SLA. Mixed method of research produces data to investigate if CALL positively affects student language proficiency, motivation and autonomy. Classroom observation of participants in their natural environment is a qualitative technique used but has situational variables that could skew results if not structured. A questionnaire is a quantitative tool that can offer insight regarding participants’ perception of performance but can contradict what the researcher has observed. This paper will take an in-depth look at variables such as: instructor’s pedagogical application; blending CALL into the curriculum; types of CALL implemented; feedback received and their implications for design of the data collection tools

Level of evidence, sponsorship, conflict of interest policy and commercial impact of PubMed-listed clinical urolithiasis-related trials in 2014.

Science.gov (United States)

Schoenthaler, Martin; Miernik, Arkadiusz; Wilhelm, Konrad; Schlager, Daniel; Schoeb, Dominik Stefan; Adams, Fabian; Dahm, Philipp; Hein, Simon

2016-05-01

To evaluate published trials on urolithiasis regarding level of evidence, type of sponsorship and declared conflicts of interest (COIs), and to elucidate a potential commercial impact. We performed a systematic PubMed(®) literature search using a predefined Boolean search term to identify PubMed-listed clinical research studies on urolithiasis in 2014 (fourth quarter). All authors screened the results for eligibility criteria and two independent reviewers evaluated and performed data extraction of predefined endpoints, including level of evidence, declaration of COI and sponsorship/funding (as indicated in the published print version), and commercial impact. A total of 110 clinical trials in urolithiasis listed in PubMed met the inclusion criteria. Levels of evidence 1, 2, 3 and 4 were found in 15%, 14%, 21% and 51% of trials, respectively. A COI was indicated in a total of 90% of publications, 93% of which declared no existing conflict of interest. Sponsorship was indicated in 36% of publications, 55% of which stated public funding, 33% institutional funding, 10% industrial funding and 2% both public and industrial funding. A total of 11% of the published trials were rated as having a high commercial impact. The present study provides evidence of increasing levels of evidence for published clinical trials on urolithiasis in 2014 (as compared with earlier data). Ninety percent of publications indicated conflicts of interest, whereas sponsoring of studies was declared only by one-third. A considerable number of trials involved issues of high commercial impact. Recently established legal programmes and voluntary acts on self-reporting of financial relationships will enhance transparency in the future; however, increased public funding will be needed to further promote the quality of trials on urolithiasis. © 2015 The Authors BJU International © 2015 BJU International Published by John Wiley & Sons Ltd.

Clinical effects of specialist and on-call respiratory physiotherapy treatments in mechanically ventilated children: A randomised crossover trial.

Science.gov (United States)

Shannon, Harriet; Stocks, Janet; Gregson, Rachael K; Dunne, Catherine; Peters, Mark J; Main, Eleanor

2015-12-01

The study investigated treatment outcomes when respiratory physiotherapy was delivered by non-respiratory on-call physiotherapists, compared with specialist respiratory physiotherapists. Prospective, randomised crossover trial. Paediatric, tertiary care hospital in the United Kingdom. Mechanically ventilated children requiring two physiotherapy interventions during a single day were eligible. Twenty two physiotherapists (10 non-respiratory) and 93 patients were recruited. Patients received one treatment from a non-respiratory physiotherapist and another from a respiratory physiotherapist, in a randomised order. Treatments were individualised to the patients' needs, often including re-positioning followed by manual lung inflations, chest wall vibrations and endotracheal suction. The primary outcome was respiratory compliance. Secondary outcomes included adverse physiological events and clinically important respiratory changes (according to an a priori definition). Treatments delivered to 63 patients were analysed. There were significant improvements to respiratory compliance (mean increase [95% confidence intervals], 0.07 and 0.08ml·cmH2O(-1)·kg(-1) [0.01 to 0.14 and 0.04 to 0.13], pphysiotherapy services, both during and outside of normal working hours. Clinicaltrials.gov, NCT01999426. Copyright © 2015 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Leveraging management information in improving call centre productivity

Directory of Open Access Journals (Sweden)

Manthisana Mosese

2016-04-01

Objectives: This research explored the use of management information and its impact on two fundamental functions namely, improving productivity without compromising the quality of service, in the call centre of a well-known South African fashion retailer, Edcon. Following the implementation of the call centre technology project the research set out to determine how Edcon can transform their call centre to improve productivity and customer service through effective utilisation of their management information. Method: Internal documents and reports were analysed to provide the basis of evaluation between the measures of productivity prior to and post the implementation of a technology project at Edcon’s call centre. Semi-structured in-depth and group interviews were conducted to establish the importance and use of management information in improving productivity and customer service. Results: The results indicated that the availability of management information has indeed contributed to improved efficiency at the Edcon call centre. Although literature claims that there is a correlation between a call centre technology upgrade and improvement in performance, evident in the return on investment being realised within a year or two of implementation, it fell beyond the scope of this study to investigate the return on investment for Edcon’s call centre. Conclusion: Although Edcon has begun realising benefits in improved productivity in their call centre from their available management information, information will continue to play a crucial role in supporting management with informed decisions that will improve the call centre operations. [pdf to follow

Piezoelectric Versus Conventional Rotary Techniques for Impacted Third Molar Extraction: A Meta-analysis of Randomized Controlled Trials.

Science.gov (United States)

Jiang, Qian; Qiu, Yating; Yang, Chi; Yang, Jingyun; Chen, Minjie; Zhang, Zhiyuan

2015-10-01

Impacted third molars are frequently encountered in clinical work. Surgical removal of impacted third molars is often required to prevent clinical symptoms. Traditional rotary cutting instruments are potentially injurious, and piezosurgery, as a new osteotomy technique, has been introduced in oral and maxillofacial surgery. No consistent conclusion has been reached regarding whether this new technique is associated with fewer or less severe postoperative sequelae after third molar extraction.The aim of this study was to compare piezosurgery with rotary osteotomy techniques, with regard to surgery time and the severity of postoperative sequelae, including pain, swelling, and trismus.We conducted a systematic literature search in the Cochrane Library, PubMed, Embase, and Google Scholar.The eligibility criteria of this study included the following: the patients were clearly diagnosed as having impacted mandibular third molars; the patients underwent piezosurgery osteotomy, and in the control group rotary osteotomy techniques, for removing impacted third molars; the outcomes of interest include surgery time, trismus, swelling or pain; the studies are randomized controlled trials.We used random-effects models to calculate the difference in the outcomes, and the corresponding 95% confidence interval. We calculated the weighted mean difference if the trials used the same measurement, and a standardized mean difference if otherwise.A total of seven studies met the eligibility criteria and were included in our analysis. Compared with rotary osteotomy, patients undergoing piezosurgery experienced longer surgery time (mean difference 4.13 minutes, 95% confidence interval 2.75-5.52, P piezosurgery groups.The number of included randomized controlled trials and the sample size of each trial were relatively small, double blinding was not possible, and cost analysis was unavailable due to a lack of data.Our meta-analysis indicates that although patients undergoing piezosurgery

Assessing the impact of a school-based latrine cleaning and handwashing program on pupil absence in Nyanza Province, Kenya: a cluster-randomized trial.

Science.gov (United States)

Caruso, Bethany A; Freeman, Matthew C; Garn, Joshua V; Dreibelbis, Robert; Saboori, Shadi; Muga, Richard; Rheingans, Richard

2014-10-01

Improving school water, sanitation and hygiene (WASH) conditions reduces pupil absence and illness. However, these benefits may depend on the conditions of the latrines and availability of consumables. We sought to determine whether a low-cost, policy-relevant, environmental-level latrine cleaning intervention could improve latrine cleanliness, increase its use and reduce absenteeism. In a three-arm, cluster-randomized trial we assessed absence via periodical roll-call among 17 564 pupils in 60 schools that had previously received WASH improvements as part of the SWASH+ project. Latrine conditions and use were also assessed using structured observation. Latrine cleanliness increased significantly during the post-intervention period among schools receiving the latrine cleaning package compared to controls, as did handwashing with soap. We found no difference in latrine use and absence across arms. The additive impact of cleaning may not have been strong enough to impact absence above and beyond reductions attributable to the original WASH infrastructure improvements and basic hygiene education the schools previously received. Improving latrine conditions is important for the dignity and well-being of pupils, and investments and strategies are necessary to ensure that school toilets are clean and pupil-friendly. © 2014 John Wiley & Sons Ltd.

Impact of late-to-refill reminder calls on medication adherence in the Medicare Part D population: evaluation of a randomized controlled study

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Taitel MS

2017-02-01

Full Text Available Michael S Taitel, Ying Mu, Angshuman Gooptu, Youbei Lou Health Analytics, Research & Reporting, Walgreen Co., Deerfield, IL, USA Objectives: This study evaluates a nationwide pharmacy chain’s late-to-refill (LTR reminder program that entails local pharmacists placing reminder calls to Medicare Part D patients. Methods: We conducted a randomized controlled study among 735,218 patients who exhibited nonadherent behavior by not refilling a maintenance medication 3 days from an expected refill date. Patients were randomly assigned to an intervention group who received LTR reminder calls or to a control group. We used Walgreens pharmaceutical claims data from 2015 to estimate the impact of LTR calls on short-term and annual adherence. Results: The initial refill rate within the first 14 days of the expected refill date significantly increased in the intervention group by 22.8% (6.09 percentage points compared to the control group (P<0.001. The proportion of days covered (PDC in the intervention group increased significantly by 1.5% (0.856 percentage points relative to the control group (P<0.001 over 365 days. Patients in the intervention group were significantly more adherent (PDC ≥80% by 3% (0.97 percentage points compared to the control group (P<0.001. Over a 270-day follow-up period, persistence significantly increased by 2.15 days in the intervention group (P<0.001. Conclusion: Results from this study suggest that LTR reminder calls increased adherence for Medicare Part D patients who are late in refilling their medications and therefore have the potential to reduce their risk for hospitalization and health care costs. Additionally, the intervention increased the number of patients with PDC ≥80% by ~3%, positively impacting Medicare Part D plan quality rating. Keywords: reminder system, tailored intervention, Medicare Part D, adherence, persistence

The impact of note taking style and note availability at retrieval on mock jurors' recall and recognition of trial information.

Science.gov (United States)

Thorley, Craig; Baxter, Rebecca E; Lorek, Joanna

2016-01-01

Jurors forget critical trial information and what they do recall can be inaccurate. Jurors' recall of trial information can be enhanced by permitting them to take notes during a trial onto blank sheets of paper (henceforth called freestyle note taking). A recent innovation is the trial-ordered-notebook (TON) for jurors, which is a notebook containing headings outlining the trial proceedings and which has space beneath each heading for notes. In a direct comparison, TON note takers recalled more trial information than freestyle note takers. This study investigated whether or not note taking improves recall as a result of enhanced encoding or as a result of note access at retrieval. To assess this, mock jurors watched and freely recalled a trial video with one-fifth taking no notes, two-fifths taking freestyle notes and two-fifths using TONs. During retrieval, half of the freestyle and TON note takers could access their notes. Note taking enhanced recall, with the freestyle note takers and TON note takers without note access performing equally as well. Note taking therefore enhances encoding. Recall was greatest for the TON note takers with note access, suggesting a retrieval enhancement unique to this condition. The theoretical and applied implications of these findings are discussed.

Consumer groups call for ban on internet pharmacies.

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Garmaise, David

2004-08-01

A number of consumer groups have called on the Canadian government to ban internet pharmacies, claiming that the industry is putting the health of Canadians at risk. The groups say that the impact will escalate if the problem is not addressed.

The experience of work in a call centre environment

Directory of Open Access Journals (Sweden)

Sanet Hauptfleisch

2006-10-01

Full Text Available This qualitative research study explored the work experience in a call centre environment in an information technology call centre based in South Africa, which service foreign customers exclusively. Three data collection methods were used, namely narratives, in-depth interviews with call centre consultants, and observation. Following a grounded theory approach, four themes were elicited, namely the perceptions of team members, uncertainty created by a constantly changing environment, perceived distances due to management practices, and depersonalisation experienced while actually dealing with customers. In addition to this, the reported impact of these themes on work performance was explored and compared to existing research.

Randomized, Controlled Trial to Examine the Impact of Providing Yogurt to Women Enrolled in WIC

Science.gov (United States)

Fung, Ellen B.; Ritchie, Lorrene D.; Walker, Brent H.; Gildengorin, Ginny; Crawford, Patricia B.

2010-01-01

Objective: Examine the impact of providing yogurt to women enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). Design: Randomized, controlled intervention trial. Setting: Two California WIC local agency sites. Participants: 511 pregnant, breast-feeding, or postpartum women. Intervention: Substitution of…

The job demands-resources model of work engagement in South African call centres

OpenAIRE

Yolandi Janse van Rensburg; Billy Boonzaier; Michèle Boonzaier

2013-01-01

Orientation: A ‘sacrificial human resource strategy’ is practised in call centres, resulting in poor employee occupational health. Consequently, questions are posed in terms of the consequences of call centre work and which salient antecedent variables impact the engagement and wellbeing of call centre representatives. Research purpose: Firstly, to gauge the level of employee engagement amongst a sample of call centre representatives in South Africa and, secondly, to track the paths throu...

Top-Down Prioritization of Salient Items May Produce the So-Called Stimulus-Driven Capture

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Hanna Benoni

2018-02-01

Full Text Available The current study proposes that top-down attentional prioritization of salient items may produce the so-called stimulus-driven capture. To test this proposal, the “expectation-based paradigm” was designed on the basis of a visual search task. In Experiment 1, a task-irrelevant singleton frame was presented at the same location in 70% of the trials. The target was either presented at chance level within the singleton location, or away from it. In line with the singleton capture phenomenon, participants were faster in identifying the target when it appeared in the singleton location compared to non-singleton locations. However, leaving out the singleton frame in 30% of the trials led to a similar effect; participants were faster in identifying the target when it appeared in the expected singleton location compared to expected non-singletons locations (a “quasi-capture” effect. These results suggest that the participants allocated their attention to the expected singleton location, rather than that the singleton itself captured attention. In Experiment 2, the same task-irrelevant color singleton was presented in a random position in 70% of the trials. This color frame was shown as a non-singleton in all of the 30% singleton-absent multicolored trials. A similar facilitation effect was obtained when the target appeared in the expected singleton color frame compared to other frames, in singleton-absent trials as in singleton-present trials. These results further support the idea that instances of singleton capture can be explained by top-down attentional shifts toward singleton items. Theoretical implications of these results are discussed. Mostly, the study calls to consider the possibility that all sources of attentional control may be represented by a continuous variable of top-down control, including the category of “physical salience.”

Top-Down Prioritization of Salient Items May Produce the So-Called Stimulus-Driven Capture

Science.gov (United States)

Benoni, Hanna

2018-01-01

The current study proposes that top-down attentional prioritization of salient items may produce the so-called stimulus-driven capture. To test this proposal, the “expectation-based paradigm” was designed on the basis of a visual search task. In Experiment 1, a task-irrelevant singleton frame was presented at the same location in 70% of the trials. The target was either presented at chance level within the singleton location, or away from it. In line with the singleton capture phenomenon, participants were faster in identifying the target when it appeared in the singleton location compared to non-singleton locations. However, leaving out the singleton frame in 30% of the trials led to a similar effect; participants were faster in identifying the target when it appeared in the expected singleton location compared to expected non-singletons locations (a “quasi-capture” effect). These results suggest that the participants allocated their attention to the expected singleton location, rather than that the singleton itself captured attention. In Experiment 2, the same task-irrelevant color singleton was presented in a random position in 70% of the trials. This color frame was shown as a non-singleton in all of the 30% singleton-absent multicolored trials. A similar facilitation effect was obtained when the target appeared in the expected singleton color frame compared to other frames, in singleton-absent trials as in singleton-present trials. These results further support the idea that instances of singleton capture can be explained by top-down attentional shifts toward singleton items. Theoretical implications of these results are discussed. Mostly, the study calls to consider the possibility that all sources of attentional control may be represented by a continuous variable of top-down control, including the category of “physical salience.” PMID:29599731

Blended call center with idling times during the call service

NARCIS (Netherlands)

Legros, Benjamin; Jouini, Oualid; Koole, Ger

We consider a blended call center with calls arriving over time and an infinitely backlogged amount of outbound jobs. Inbound calls have a non-preemptive priority over outbound jobs. The inbound call service is characterized by three successive stages where the second one is a break; i.e., there is

Heart rate variability changes in physicians working on night call.

Science.gov (United States)

Malmberg, Birgitta; Persson, Roger; Flisberg, Per; Ørbaek, Palle

2011-03-01

Adverse effects by night-call duty have become an important occupational health issue. The aim of this study was to investigate whether the heart rate variability (HRV) differed during recovery from day work and night-call duty between distinct physician specialities. We studied the impact of a 16-h night-call duty on autonomic balance, measured by HRV, among two physician groups differing with respect to having to deal with life-threatening conditions while on call. Nineteen anaesthesiologists (ANEST) and 16 paediatricians and ear, nose and throat surgeons (PENT) were monitored by ambulatory digital Holter electrocardiogram (ECG). Heart rate variability was analysed between 21:00 and 22:00 after an ordinary workday, on night call and in the evening post-call. Absolute and normalized high-frequency power (HF, HFnu) were the main outcome variables, expressing parasympathetic influence on the heart. ANEST had lower HF power than PENT while on night call and post-daytime work (p work compared with post-night-call duty (p balance and did not differ between specialities. However, the less dynamic HRV after daytime work and during night-call duty in the ANEST group may indicate a higher physiological stress level. These results may contribute to the improvement of night-call schedules within the health care sector.

The effect of journal impact factor, reporting conflicts, and reporting funding sources, on standardized effect sizes in back pain trials: a systematic review and meta-regression.

Science.gov (United States)

Froud, Robert; Bjørkli, Tom; Bright, Philip; Rajendran, Dévan; Buchbinder, Rachelle; Underwood, Martin; Evans, David; Eldridge, Sandra

2015-11-30

Low back pain is a common and costly health complaint for which there are several moderately effective treatments. In some fields there is evidence that funder and financial conflicts are associated with trial outcomes. It is not clear whether effect sizes in back pain trials relate to journal impact factor, reporting conflicts of interest, or reporting funding. We performed a systematic review of English-language papers reporting randomised controlled trials of treatments for non-specific low back pain, published between 2006-2012. We modelled the relationship using 5-year journal impact factor, and categories of reported of conflicts of interest, and categories of reported funding (reported none and reported some, compared to not reporting these) using meta-regression, adjusting for sample size, and publication year. We also considered whether impact factor could be predicted by the direction of outcome, or trial sample size. We could abstract data to calculate effect size in 99 of 146 trials that met our inclusion criteria. Effect size is not associated with impact factor, reporting of funding source, or reporting of conflicts of interest. However, explicitly reporting 'no trial funding' is strongly associated with larger absolute values of effect size (adjusted β=1.02 (95 % CI 0.44 to 1.59), P=0.001). Impact factor increases by 0.008 (0.004 to 0.012) per unit increase in trial sample size (Psources of funding, and conflicts of interest reflects positively on research and publisher conduct in the field. Strong evidence of a large association between absolute magnitude of effect size and explicit reporting of 'no funding' suggests authors of unfunded trials are likely to report larger effect sizes, notwithstanding direction. This could relate in part to quality, resources, and/or how pragmatic a trial is.

Impact on learning of an e-learning module on leukaemia: a randomised controlled trial.

Science.gov (United States)

Morgulis, Yuri; Kumar, Rakesh K; Lindeman, Robert; Velan, Gary M

2012-05-28

e-learning resources may be beneficial for complex or conceptually difficult topics. Leukaemia is one such topic, yet there are no reports on the efficacy of e-learning for leukaemia. This study compared the learning impact on senior medical students of a purpose-built e-learning module on leukaemia, compared with existing online resources. A randomised controlled trial was performed utilising volunteer senior medical students. Participants were randomly allocated to Study and Control groups. Following a pre-test on leukaemia administered to both groups, the Study group was provided with access to the new e-learning module, while the Control group was directed to existing online resources. A post-test and an evaluation questionnaire were administered to both groups at the end of the trial period. Study and Control groups were equivalent in gender distribution, mean academic ability, pre-test performance and time studying leukaemia during the trial. The Study group performed significantly better than the Control group in the post-test, in which the group to which the students had been allocated was the only significant predictor of performance. The Study group's evaluation of the module was overwhelmingly positive. A targeted e-learning module on leukaemia had a significant effect on learning in this cohort, compared with existing online resources. We believe that the interactivity, dialogic feedback and integration with the curriculum offered by the e-learning module contributed to its impact. This has implications for e-learning design in medicine and other disciplines.

The impact of phone calls on follow-up rates in an online depression prevention study

Directory of Open Access Journals (Sweden)

R.F. Muñoz

2017-06-01

Conclusions: Adding phone call contacts to email reminders and monetary incentives did increase follow-up rates. However, the rate of response to follow-up was low and the number of phone calls required to achieve one completed follow-up raises concerns about the utility of adding phone calls. We also discuss difficulties with using financial incentives and their implications.

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.

Influence of a New "Call-Out Algorithm" for Management of Postoperative Pain and Its Side Effects on Length of Stay in Hospital: A Two-Centre Prospective Randomized Trial.

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Dybvik, Lisa; Skraastad, Erlend; Yeltayeva, Aigerim; Konkayev, Aidos; Musaeva, Tatiana; Zabolotskikh, Igor; Bjertnaes, Lars; Dahl, Vegard; Raeder, Johan; Kuklin, Vladimir

2017-01-01

We recently introduced the efficacy safety score (ESS) as a new "call-out algorithm" for management of postoperative pain and side effects. In this study, we report the influence of ESS recorded hourly during the first 8 hours after surgery on the mobility degree, postoperative nonsurgical complications, and length of hospital stay (LOS). We randomized 1152 surgical patients into three groups for postoperative observation: (1) ESS group ( n = 409), (2) Verbal Numeric Rate Scale (VNRS) for pain group ( n = 417), and (3) an ordinary qualitative observation (Control) group ( n = 326). An ESS > 10 or VNRS > 4 at rest or a nurse's observation of pain or adverse reaction to analgesic treatment in the Control group served as a "call-out alarm" for an anaesthesiologist. We found no significant differences in the mobility degree and number of postoperative nonsurgical complications between the groups. LOS was significantly shorter with 12.7 ± 6.3 days (mean ± SD) in the ESS group versus 14.2 ± 6.2 days in the Control group ( P < 0.001). Postoperative ESS recording in combination with the possibility to call upon an anaesthesiologist when exceeding the threshold score might have contributed to the reductions of LOS in this two-centre study. This trial is registered with NCT02143128.

Redesigning Radiotherapy Quality Assurance: Opportunities to Develop an Efficient, Evidence-Based System to Support Clinical Trials

Science.gov (United States)

Bekelman, Justin E.; Deye, James A.; Vikram, Bhadrasain; Bentzen, Soren M.; Bruner, Deborah; Curran, Walter J.; Dignam, James; Efstathiou, Jason A.; FitzGerald, T. J.; Hurkmans, Coen; Ibbott, Geoffrey S.; Lee, J. Jack; Merchant, Timothy E.; Michalski, Jeff; Palta, Jatinder R.; Simon, Richard; Ten Haken, Randal K.; Timmerman, Robert; Tunis, Sean; Coleman, C. Norman; Purdy, James

2012-01-01

Background In the context of national calls for reorganizing cancer clinical trials, the National Cancer Institute (NCI) sponsored a two day workshop to examine the challenges and opportunities for optimizing radiotherapy quality assurance (QA) in clinical trial design. Methods Participants reviewed the current processes of clinical trial QA and noted the QA challenges presented by advanced technologies. Lessons learned from the radiotherapy QA programs of recent trials were discussed in detail. Four potential opportunities for optimizing radiotherapy QA were explored, including the use of normal tissue toxicity and tumor control metrics, biomarkers of radiation toxicity, new radiotherapy modalities like proton beam therapy, and the international harmonization of clinical trial QA. Results Four recommendations were made: 1) Develop a tiered (and more efficient) system for radiotherapy QA and tailor intensity of QA to clinical trial objectives. Tiers include (i) general credentialing, (ii) trial specific credentialing, and (iii) individual case review; 2) Establish a case QA repository; 3) Develop an evidence base for clinical trial QA and introduce innovative prospective trial designs to evaluate radiotherapy QA in clinical trials; and 4) Explore the feasibility of consolidating clinical trial QA in the United States. Conclusion Radiotherapy QA may impact clinical trial accrual, cost, outcomes and generalizability. To achieve maximum benefit, QA programs must become more efficient and evidence-based. PMID:22425219

Precision Medicine for Advanced Pancreas Cancer: The Individualized Molecular Pancreatic Cancer Therapy (IMPaCT) Trial.

Science.gov (United States)

Chantrill, Lorraine A; Nagrial, Adnan M; Watson, Clare; Johns, Amber L; Martyn-Smith, Mona; Simpson, Skye; Mead, Scott; Jones, Marc D; Samra, Jaswinder S; Gill, Anthony J; Watson, Nicole; Chin, Venessa T; Humphris, Jeremy L; Chou, Angela; Brown, Belinda; Morey, Adrienne; Pajic, Marina; Grimmond, Sean M; Chang, David K; Thomas, David; Sebastian, Lucille; Sjoquist, Katrin; Yip, Sonia; Pavlakis, Nick; Asghari, Ray; Harvey, Sandra; Grimison, Peter; Simes, John; Biankin, Andrew V

2015-05-01

Personalized medicine strategies using genomic profiling are particularly pertinent for pancreas cancer. The Individualized Molecular Pancreatic Cancer Therapy (IMPaCT) trial was initially designed to exploit results from genome sequencing of pancreatic cancer under the auspices of the International Cancer Genome Consortium (ICGC) in Australia. Sequencing revealed small subsets of patients with aberrations in their tumor genome that could be targeted with currently available therapies. The pilot stage of the IMPaCT trial assessed the feasibility of acquiring suitable tumor specimens for molecular analysis and returning high-quality actionable genomic data within a clinically acceptable timeframe. We screened for three molecular targets: HER2 amplification; KRAS wild-type; and mutations in DNA damage repair pathways (BRCA1, BRCA2, PALB2, ATM). Tumor biopsy and archived tumor samples were collected from 93 patients and 76 were screened. To date 22 candidate cases have been identified: 14 KRAS wild-type, 5 cases of HER2 amplification, 2 mutations in BRCA2, and 1 ATM mutation. Median time from consent to the return of validated results was 21.5 days. An inability to obtain a biopsy or insufficient tumor content in the available specimen were common reasons for patient exclusion from molecular analysis while deteriorating performance status prohibited a number of patients from proceeding in the study. Documenting the feasibility of acquiring and screening biospecimens for actionable molecular targets in real time will aid other groups embarking on similar trials. Key elements include the need to better prescreen patients, screen more patients, and offer more attractive clinical trial options. ©2015 American Association for Cancer Research.

Impact of managed care on cancer trial enrollment.

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Gross, C P; Krumholz, H M

2005-06-01

To determine the relationship between managed care market activity and cancer trial enrollment. Trial participant data were obtained from the National Cancer Institute. Participants in cooperative group trials of breast, colorectal, lung, or prostate cancer during the years 1996 through 2001 were assigned to counties based on their zip code of residence. Linear regression was used to determine the relationship between county enrollment rate and two measures of county managed care activity (penetration and index of competition [IOC]), adjusting for other county characteristics. In bivariate analysis, there was a strong inverse correlation between trial enrollment rate and IOC (r = -0.23; P penetration, proportion uninsured, and other county characteristics. Counties in the lowest quartile of managed care penetration tended to have lower enrollment rates than the remaining counties (r = -0.05; P = .048), while counties in the second, third, and fourth quartiles of penetration all had similar enrollment rates to one another. Cancer trial enrollment rates were suboptimal across all counties, and counties with higher levels of managed care competition had significantly lower enrollment rates. The relationship between managed care penetration and trial enrollment was less consistent. Future efforts to enhance trial participation should address the potential negative influence of market factors.

Publication Speed, Reporting Metrics, and Citation Impact of Cardiovascular Trials Supported by the National Heart, Lung, and Blood Institute.

Science.gov (United States)

Gordon, David; Cooper-Arnold, Katharine; Lauer, Michael

2015-07-31

We previously demonstrated that cardiovascular (CV) trials funded by the National Heart, Lung, and Blood Institute (NHLBI) were more likely to be published in a timely manner and receive high raw citation counts if they focused on clinical endpoints. We did not examine the metrics of trial reports, and our citation measures were limited by failure to account for topic-related citation behaviors. Of 244 CV trials completed between 2000 and 2011, we identified 184 whose main results were published by August 20, 2014. One investigator who was blinded to rapidity of publication and citation data read each publication and characterized it according to modified Delphi criteria. There were 46 trials (25%) that had Delphi scores of 8 or 9 (of a possible 9); these trials published faster (median time from trial completion to publication, 12.6 [interquartile range {IQR}, 6.7 to 23.3] vs. 21.8 [IQR, 12.1 to 34.9] months; Pcitation impact (median citation percentile for topic and date of publication, with 0 best and 100 worst, 1.92 [IQR, 0.64 to 7.83] vs. 8.41 [IQR, 1.80 to 24.75]; P=0.002). By random forest regression, we found that the 3 most important predictors of normalized citation percentile values were total costs, intention-to-treat analyses (as a modified Delphi quality measure), and focus on clinical (not surrogate) endpoints. NHLBI CV trials were more likely to publish results quickly and yield higher topic-normalized citation impact if they reported results according to well-defined metrics, along with focus on clinical endpoints. © 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Impact of food supplementation on weight loss in randomised-controlled dietary intervention trials: a systematic review and meta-analysis.

Science.gov (United States)

Wibisono, Cinthya; Probst, Yasmine; Neale, Elizabeth; Tapsell, Linda

2016-04-01

Dietary trials provide evidence for practice and policy guidelines, but poor adherence may confound results. Food supplementation may improve adherence to dietary interventions, but the impact of supplementation on study outcomes is not known. The aim of this review was to examine the impact of food supplementation on weight loss in dietary intervention trials. The databases Scopus, PubMed and the Cochrane Library were searched for dietary intervention trials published between January 2004 and March 2015 using the following keyword combinations: 'trial' OR 'intervention', 'food' OR 'diet', 'weight loss' and 'adherence' OR 'adherence'. Studies were included if food was provided to at least one study group and both 'weight change' and 'adherence' were reported. Random effects meta-analyses were conducted to assess weighted mean differences (WMD) in body weight (change or final mean values). The included studies formed two groups: trials involving an intervention group supplemented with a food and a control without food supplementation (food v. no food), and trials in which food was provided to all subjects (food v. food) (PROSPERO registration: CRD42015017563). In total, sixteen studies were included. Significant weight reduction was reported in the food v. no food studies (WMD -0·74 kg; 95 % CI -1·40, -0·08; P=0·03, I 2=63 %). A non-significant increase in weight was found among the food v. food studies (WMD 0·84 kg; 95 % CI -0·60, 2·27; P=0·25, I 2=0 %). Food supplementation appeared to result in greater weight loss in dietary trials. Energy restrictions and intensity of interventions were other significant factors influencing weight loss.

Impact on learning of an e-learning module on leukaemia: a randomised controlled trial

Directory of Open Access Journals (Sweden)

Morgulis Yuri

2012-05-01

Full Text Available Abstract Background e-learning resources may be beneficial for complex or conceptually difficult topics. Leukaemia is one such topic, yet there are no reports on the efficacy of e-learning for leukaemia. This study compared the learning impact on senior medical students of a purpose-built e-learning module on leukaemia, compared with existing online resources. Methods A randomised controlled trial was performed utilising volunteer senior medical students. Participants were randomly allocated to Study and Control groups. Following a pre-test on leukaemia administered to both groups, the Study group was provided with access to the new e-learning module, while the Control group was directed to existing online resources. A post-test and an evaluation questionnaire were administered to both groups at the end of the trial period. Results Study and Control groups were equivalent in gender distribution, mean academic ability, pre-test performance and time studying leukaemia during the trial. The Study group performed significantly better than the Control group in the post-test, in which the group to which the students had been allocated was the only significant predictor of performance. The Study group’s evaluation of the module was overwhelmingly positive. Conclusions A targeted e-learning module on leukaemia had a significant effect on learning in this cohort, compared with existing online resources. We believe that the interactivity, dialogic feedback and integration with the curriculum offered by the e-learning module contributed to its impact. This has implications for e-learning design in medicine and other disciplines.

Impact on learning of an e-learning module on leukaemia: a randomised controlled trial

Science.gov (United States)

2012-01-01

Background e-learning resources may be beneficial for complex or conceptually difficult topics. Leukaemia is one such topic, yet there are no reports on the efficacy of e-learning for leukaemia. This study compared the learning impact on senior medical students of a purpose-built e-learning module on leukaemia, compared with existing online resources. Methods A randomised controlled trial was performed utilising volunteer senior medical students. Participants were randomly allocated to Study and Control groups. Following a pre-test on leukaemia administered to both groups, the Study group was provided with access to the new e-learning module, while the Control group was directed to existing online resources. A post-test and an evaluation questionnaire were administered to both groups at the end of the trial period. Results Study and Control groups were equivalent in gender distribution, mean academic ability, pre-test performance and time studying leukaemia during the trial. The Study group performed significantly better than the Control group in the post-test, in which the group to which the students had been allocated was the only significant predictor of performance. The Study group’s evaluation of the module was overwhelmingly positive. Conclusions A targeted e-learning module on leukaemia had a significant effect on learning in this cohort, compared with existing online resources. We believe that the interactivity, dialogic feedback and integration with the curriculum offered by the e-learning module contributed to its impact. This has implications for e-learning design in medicine and other disciplines. PMID:22640463

Multidisciplinary Responses to the Sexual Victimization of Children: Use of Control Phone Calls.

Science.gov (United States)

Canavan, J William; Borowski, Christine; Essex, Stacy; Perkowski, Stefan

2017-10-01

This descriptive study addresses the question of the value of one-party consent phone calls regarding the sexual victimization of children. The authors reviewed 4 years of experience with children between the ages of 3 and 18 years selected for the control phone calls after a forensic interview by the New York State Police forensic interviewer. The forensic interviewer identified appropriate cases for control phone calls considering New York State law, the child's capacity to make the call, the presence of another person to make the call and a supportive residence. The control phone call process has been extremely effective forensically. Offenders choose to avoid trial by taking a plea bargain thereby dramatically speeding up the criminal judicial and family court processes. An additional outcome of the control phone call is the alleged offender's own words saved the child from the trauma of testifying in court. The control phone call reduced the need for children to repeat their stories to various interviewers. A successful control phone call gives the child a sense of vindication. This technique is the only technique that preserves the actual communication pattern between the alleged victim and the alleged offender. This can be of great value to the mental health professionals working with both the child and the alleged offender. Cautions must be considered regarding potential serious adverse effects on the child. The multidisciplinary team members must work together in the control phone call. The descriptive nature of this study did not allow the authors adequate demographic data, a subject that should be addressed in future prospective study.

Center-Within-Trial Versus Trial-Level Evaluation of Surrogate Endpoints

Science.gov (United States)

Renfro, Lindsay A.; Shi, Qian; Xue, Yuan; Li, Junlong; Shang, Hongwei; Sargent, Daniel J.

2014-01-01

Evaluation of candidate surrogate endpoints using individual patient data from multiple clinical trials is considered the gold standard approach to validate surrogates at both patient and trial levels. However, this approach assumes the availability of patient-level data from a relatively large collection of similar trials, which may not be possible to achieve for a given disease application. One common solution to the problem of too few similar trials involves performing trial-level surrogacy analyses on trial sub-units (e.g., centers within trials), thereby artificially increasing the trial-level sample size for feasibility of the multi-trial analysis. To date, the practical impact of treating trial sub-units (centers) identically to trials in multi-trial surrogacy analyses remains unexplored, and conditions under which this ad hoc solution may in fact be reasonable have not been identified. We perform a simulation study to identify such conditions, and demonstrate practical implications using a multi-trial dataset of patients with early stage colon cancer. PMID:25061255

Dynamic call center routing policies using call waiting and agent idle times

NARCIS (Netherlands)

Chan, W.; Koole, G.M.; L'Ecuyer, P.

2014-01-01

We study call routing policies for call centers with multiple call types and multiple agent groups. We introduce new weight-based routing policies where each pair (call type, agent group) is given a matching priority defined as an affine combination of the longest waiting time for that call type and

Acoustic Structure and Contextual Use of Calls by Captive Male and Female Cheetahs (Acinonyx jubatus).

Science.gov (United States)

Smirnova, Darya S; Volodin, Ilya A; Demina, Tatyana S; Volodina, Elena V

2016-01-01

The vocal repertoire of captive cheetahs (Acinonyx jubatus) and the specific role of meow vocalizations in communication of this species attract research interest about two dozen years. Here, we expand this research focus for the contextual use of call types, sex differences and individual differences at short and long terms. During 457 trials of acoustic recordings, we collected calls (n = 8120) and data on their contextual use for 13 adult cheetahs (6 males and 7 females) in four Russian zoos. The cheetah vocal repertoire comprised 7 call types produced in 8 behavioural contexts. Context-specific call types (chirr, growl, howl and hiss) were related to courting behaviour (chirr) or to aggressive behaviour (growl, howl and hiss). Other call types (chirp, purr and meow) were not context-specific. The values of acoustic variables differed between call types. The meow was the most often call type. Discriminant function analysis revealed a high potential of meows to encode individual identity and sex at short terms, however, the vocal individuality was unstable over years. We discuss the contextual use and acoustic variables of call types, the ratios of individual and sex differences in calls and the pathways of vocal ontogeny in the cheetah with relevant data on vocalization of other animals.

Acoustic Structure and Contextual Use of Calls by Captive Male and Female Cheetahs (Acinonyx jubatus.

Directory of Open Access Journals (Sweden)

Darya S Smirnova

Full Text Available The vocal repertoire of captive cheetahs (Acinonyx jubatus and the specific role of meow vocalizations in communication of this species attract research interest about two dozen years. Here, we expand this research focus for the contextual use of call types, sex differences and individual differences at short and long terms. During 457 trials of acoustic recordings, we collected calls (n = 8120 and data on their contextual use for 13 adult cheetahs (6 males and 7 females in four Russian zoos. The cheetah vocal repertoire comprised 7 call types produced in 8 behavioural contexts. Context-specific call types (chirr, growl, howl and hiss were related to courting behaviour (chirr or to aggressive behaviour (growl, howl and hiss. Other call types (chirp, purr and meow were not context-specific. The values of acoustic variables differed between call types. The meow was the most often call type. Discriminant function analysis revealed a high potential of meows to encode individual identity and sex at short terms, however, the vocal individuality was unstable over years. We discuss the contextual use and acoustic variables of call types, the ratios of individual and sex differences in calls and the pathways of vocal ontogeny in the cheetah with relevant data on vocalization of other animals.

Effect of European Clinical Trials Directive on academic drug trials in Denmark: retrospective study of applications to the Danish Medicines Agency 1993-2006

DEFF Research Database (Denmark)

Berendt, Louise; Hakansson, Cecilia; Bach, Karin Ursula Friis

2008-01-01

To determine the impact of the European Union's Clinical Trials Directive on the number of academic drug trials carried out in Denmark.......To determine the impact of the European Union's Clinical Trials Directive on the number of academic drug trials carried out in Denmark....

The INCA trial (Impact of NOD2 genotype-guided antibiotic prevention on survival in patients with liver Cirrhosis and Ascites): study protocol for a randomized controlled trial.

Science.gov (United States)

Casper, Markus; Mengel, Martin; Fuhrmann, Christine; Herrmann, Eva; Appenrodt, Beate; Schiedermaier, Peter; Reichert, Matthias; Bruns, Tony; Engelmann, Cornelius; Grünhage, Frank; Lammert, Frank

2015-03-08

Patients with liver cirrhosis have a highly elevated risk of developing bacterial infections that significantly decrease survival rates. One of the most relevant infections is spontaneous bacterial peritonitis (SBP). Recently, NOD2 germline variants were found to be potential predictors of the development of infectious complications and mortality in patients with cirrhosis. The aim of the INCA (Impact of NOD2 genotype-guided antibiotic prevention on survival in patients with liver Cirrhosis and Ascites) trial is to investigate whether survival of this genetically defined high-risk group of patients with cirrhosis defined by the presence of NOD2 variants is improved by primary antibiotic prophylaxis of SBP. The INCA trial is a double-blind, placebo-controlled clinical trial with two parallel treatment arms (arm 1: norfloxacin 400 mg once daily; arm 2: placebo once daily; 12-month treatment and observational period). Balanced randomization of 186 eligible patients with stratification for the protein content of the ascites (INCA trial is first in the field of hepatology aimed at rapidly transferring and validating information on individual genetic risk into clinical decision algorithms. German Clinical Trials Register DRKS00005616 . Registered 22 January 2014. EU Clinical Trials Register EudraCT 2013-001626-26 . Registered 26 January 2015.

[Work-family conflict in call center].

Science.gov (United States)

Ghislieri, Chiara; Ricotta, Simona; Colombo, Lara

2012-01-01

The working environment of call centers, which have seen a significant growth in recent years, has been the subject of several studies aiming at understanding its specific dynamics, with particular attention to the possible causes of stress and discomfort. Despite the fact that the work-family conflict is considered a source of stress responsible for undermining workers' well-being, and as such has been explored in many work environments, there is still very little research specific to call centers. This study had the following aims: to explore work-family conflict perceived by call-center operators taking account of any differences related to respondents'professional and personal characteristics; to understand which demands and resources can have an impact on work-family conflict in this context. The study was carried out on a sample of 898 call center operators in a telecommunications company through the administration of a self-reporting questionnaire. Data analysis included: t-test, one-way analysis of variance, linear correlations and multiple regressions. A higher perception of work-family conflict among workers having a full-time contract was observed compared to those having part-time contracts. Multiple regression analysis identified as sources of influence on work-family conflict: emotional dissonance, uneasiness due customer dissatisfaction, workload, avoidance coping and working hours. Work-family conflict in the context studied is not particularly critical: it is in part influenced by professional and personal characteristics of respondents and primarily caused by work demands. Managerial implications are discussed, especially referred to training activities.

Impact of additional counselling sessions through phone calls on smoking cessation outcomes among smokers in Penang State, Malaysia.

Science.gov (United States)

Blebil, Ali Qais; Sulaiman, Syed Azhar Syed; Hassali, Mohamed Azmi; Dujaili, Juman Abdulelah; Zin, Alfian Mohamed

2014-05-16

Studies all over the world reported that smoking relapses occur during the first two weeks after a quit date. The current study aimed to assess the impact of the additional phone calls counselling during the first month on the abstinence rate at 3 and 6 months after quit date among smokers in Penang, Malaysia. The study was conducted at Quit Smoking Clinic of two major hospitals in Penang, Malaysia. All the eligible smokers who attended the clinics between February 1st and October 31st 2012 were invited. Participants were randomly assigned by using urn design method either to receive the usual care that followed in the clinics (control) or the usual care procedure plus extra counselling sessions through phone calls during the first month of quit attempt (intervention). Participants in our cohort smoked about 14 cigarettes per day on average (mean = 13.78 ± 7.0). At 3 months, control group was less likely to quit smoking compared to intervention group (36.9% vs. 46.7%, verified smoking status) but this did not reach statistical significance (OR = 0.669; 95% CI = 0.395-1.133, P = 0.86). However, at 6 months, 71.7% of the intervention group were successfully quit smoking (bio-chemically verified) compared to 48.6% of the control group (P < 0.001). The control group were significantly less likely to quit smoking (OR = 0.375; 95% CI = 0.217-0.645, P < 0.001). Smoking cessation intervention consisting of phone calls counselling delivered during the first month of quit attempt revealed significantly higher abstinence rates compared with a standard care approach. Therefore, the additional counselling in the first few weeks after stop smoking is a promising treatment strategy that should be evaluated further. TCTR20140504001.

The so-called "Spanish model" - Tobacco industry strategies and its impact in Europe and Latin America

Directory of Open Access Journals (Sweden)

Schneider Nick K

2011-12-01

Full Text Available Abstract Background To demonstrate the tobacco industry rationale behind the "Spanish model" on non-smokers' protection in hospitality venues and the impact it had on some European and Latin American countries between 2006 and 2011. Methods Tobacco industry documents research triangulated against news and media reports. Results As an alternative to the successful implementation of 100% smoke-free policies, several European and Latin American countries introduced partial smoking bans based on the so-called "Spanish model", a legal framework widely advocated by parts of the hospitality industry with striking similarities to "accommodation programmes" promoted by the tobacco industry in the late 1990s. These developments started with the implementation of the Spanish tobacco control law (Ley 28/2005 in 2006 and have increased since then. Conclusion The Spanish experience demonstrates that partial smoking bans often resemble tobacco industry strategies and are used to spread a failed approach on international level. Researchers, advocates and policy makers should be aware of this ineffective policy.

The so-called "Spanish model" - Tobacco industry strategies and its impact in Europe and Latin America

Science.gov (United States)

2011-01-01

Background To demonstrate the tobacco industry rationale behind the "Spanish model" on non-smokers' protection in hospitality venues and the impact it had on some European and Latin American countries between 2006 and 2011. Methods Tobacco industry documents research triangulated against news and media reports. Results As an alternative to the successful implementation of 100% smoke-free policies, several European and Latin American countries introduced partial smoking bans based on the so-called "Spanish model", a legal framework widely advocated by parts of the hospitality industry with striking similarities to "accommodation programmes" promoted by the tobacco industry in the late 1990s. These developments started with the implementation of the Spanish tobacco control law (Ley 28/2005) in 2006 and have increased since then. Conclusion The Spanish experience demonstrates that partial smoking bans often resemble tobacco industry strategies and are used to spread a failed approach on international level. Researchers, advocates and policy makers should be aware of this ineffective policy. PMID:22151884

Consent revisited: the impact of return of results on participants' views and expectations about trial participation.

Science.gov (United States)

Tarrant, Carolyn; Jackson, Clare; Dixon-Woods, Mary; McNicol, Sarah; Kenyon, Sara; Armstrong, Natalie

2015-12-01

Increasingly, the sharing of study results with participants is advocated as an element of good research practice. Yet little is known about how receiving the results of trials may impact on participants' perceptions of their original decision to consent. We explored participants' views of their decision to consent to a clinical trial after they received results showing adverse outcomes in some arms of the trial. Semi-structured interviews were conducted with a purposive sample of 38 women in the UK who participated in a trial of antibiotics in pregnancy. All had received results from a follow-up study that reported increased risk of adverse outcomes for children of participants in some of the trial intervention arms. Data analysis was based on the constant comparative method. Participants' original decisions to consent to the trial had been based on hope of personal benefit and assumptions of safety. On receiving the results, most made sense of their experience in ways that enabled them to remain content with their decision to take part. But for some, the results provoked recognition that their original expectations might have been mistaken or that they had not understood the implications of their decision to participate. These participants experienced guilt, a sense of betrayal by the maternity staff and researchers involved in the trial, and damage to trust. Sharing of study results is not a wholly benign practice, and requires careful development of suitable approaches for further evaluation before widespread adoption. © 2015 The Authors Health Expectations Published by John Wiley & Sons Ltd.

The Impacts of Inclusion in Clinical Trials on Outcomes among Patients with Metastatic Breast Cancer (MBC.

Directory of Open Access Journals (Sweden)

Ji Yun Lee

Full Text Available Metastatic breast cancer (MBC remains a devastating and incurable disease. Over the past decade, the implementation of clinical trials both with and without molecular targeted therapeutics has impacted the daily clinical treatment of patients with MBC. In this study, we determine whether including MBC patients in clinical trials affects clinical outcomes.We retrospectively reviewed data for a total of 863 patients diagnosed with initial or recurrent (after receiving adjuvant systemic treatments following surgery metastatic disease between January 2000 and December 2013. Data were obtained from the breast cancer database of Samsung Medical Center.Among the 806 patients selected for inclusion, 188 (23% had participated in clinical trials. A total of 185 clinical trials were conducted from 2000 to 2014. When compared with earlier periods (n = 10 for 2000-2004, clinical trial enrollment significantly increased over time (n = 103 for 2005-2009, P = 0.024; n = 110 for 2010-2014, P = 0.046. Multivariate analyses revealed that biologic subtype, distant recurrence free interval (DRFI, and clinical trial enrollment were independent predictors of overall survival. Patients who participated in clinical trials showed improved survival, with a hazard ratio of 0.75 (95% CI, 0.59-0.95, which was associated with a 25% reduction in the risk of death. However, subgroup analysis showed that this improved survival benefit was not maintained in patients with triple negative breast cancer (TNBC.Although not conclusive, we could speculate that there were differences in the use of newer agents or regimens over time, and these differences appear to be associated with improved survival.

Vocal symptoms, voice activity, and participation profile and professional performance of call center operators.

Science.gov (United States)

Piwowarczyk, Tatiana Carvalho; Oliveira, Gisele; Lourenço, Luciana; Behlau, Mara

2012-03-01

To analyze the phonatory and laryngopharyngeal symptoms reported by call center operators; and quantify the impact of these symptoms on quality of life, and the association between these issues and professional performance, number of monthly calls, and number of missed workdays. Call center operators (n=157) from a billing call center completed the Vocal Signs and Symptoms Questionnaire and the Brazilian version of the Voice Activity and Participation Profile (VAPP). The company provided data regarding professional performance, average number of monthly calls, and number of missed workdays for each employee. The mean number of current symptoms (6.8) was greater in the operators than data for the general population (1.7). On average, 4.2 symptoms were attributed to occupational factors. The average number of symptoms did not correlate with professional performance (P=0.571). However, fewer symptoms correlated with decreased missed workdays and higher mean monthly call figures. The VAPP scores were relatively low, suggesting little impact of voice difficulties on call center operator's quality of life. However, subjects with elevated VAPP scores also had poorer professional performance. The presence of vocal symptoms does not necessarily relate to decreased professional performance. However, an association between higher vocal activity limitation and participation scores and poorer professional performance was observed. Copyright © 2012 The Voice Foundation. Published by Mosby, Inc. All rights reserved.

Condoms and sexual health education as evidence: impact of criminalization of in-call venues and managers on migrant sex workers access to HIV/STI prevention in a Canadian setting

OpenAIRE

Anderson, S.; Shannon, K.; Li, J.; Lee, Y.; Chettiar, J.; Goldenberg, S.; Kr?si, A.

2016-01-01

Background Despite a large body of evidence globally demonstrating that the criminalization of sex workers increases HIV/STI risks, we know far less about the impact of criminalization and policing of managers and in-call establishments on HIV/STI prevention among sex workers, and even less so among migrant sex workers. Methods Analysis draws on ethnographic fieldwork and 46 qualitative interviews with migrant sex workers, managers and business owners of in-call sex work venues in Metro Vanco...

47 CFR 22.921 - 911 call processing procedures; 911-only calling mode.

Science.gov (United States)

2010-10-01

... programming in the mobile unit that determines the handling of a non-911 call and permit the call to be... CARRIER SERVICES PUBLIC MOBILE SERVICES Cellular Radiotelephone Service § 22.921 911 call processing procedures; 911-only calling mode. Mobile telephones manufactured after February 13, 2000 that are capable of...

The impact of free trial acceptance on demand for alternative nicotine products: evidence from experimental auctions.

Science.gov (United States)

Rousu, Matthew C; O'Connor, Richard J; Bansal-Travers, Maansi; Pitcavage, James M; Thrasher, James F

2015-06-11

This study explored the relationship between product trials and consumer demand for alternative nicotine products (ANP). An experimental auction was conducted with 258 adult smokers, wherein participants were randomly assigned to one of four experimental conditions. The participants received the opportunity to try, but did not have to accept, one of three relatively novel ST products (i.e., snus, dissolvable tobacco, or medicinal nicotine), or they were placed into a control group (i.e., no trial). All the participants then bid on all three of these products, as well as on cigarettes. We assessed interest in using ANP based on both trial of the product and bids placed for the products in the experimental auction. Fewer smokers were willing to try snus (44%) than dissolvable tobacco (64%) or medicine nicotine (68%). For snus, we find modest evidence suggesting that willingness to try is associated with greater demand for the product. For dissolvable tobacco or medicinal nicotine, we find no evidence that those who accept the product trial have higher demand for the product. Free trials of a novel ANP were not strongly associated with product demand, as assessed by willingness to pay. Given the debate over the potential for ANP to reduce the harm from smoking, these results are important in understanding the impact of free trial offers on adoption of ST product as a strategy to reduce harm from tobacco use.

The impact of an exercise intervention on C - reactive protein during pregnancy: a randomized controlled trial.

Science.gov (United States)

Hawkins, Marquis; Braun, Barry; Marcus, Bess H; Stanek, Edward; Markenson, Glenn; Chasan-Taber, Lisa

2015-06-24

C-reactive protein (CRP) during pregnancy has been associated with adverse maternal outcomes such as preeclampsia and gestational diabetes mellitus. Randomized trials suggest that exercise programs may be associated with reductions in CRP in non-pregnant populations; however, such studies have not been conducted among pregnant women. The purpose of this study was to evaluate the impact of an individually-tailored motivationally-matched exercise intervention on CRP in pregnant women. The Behaviors Affecting Baby and You study was a randomized controlled trial of prenatal physical activity to prevent the development of gestational diabetes mellitus in women at increased risk. Women were randomized to either a 12-week exercise intervention (n = 84) or a comparison health and wellness intervention (n = 87). High sensitivity CRP (mg/dL) was measured using a commercial immunoassay kit. Physical activity was measured using the Pregnancy Physical Activity Questionnaire. Mixed model analyses were used to evaluate the impact of the intervention on change in CRP using an intent-to-treat approach. CRP decreased (-0.09 mg/dL, 95 % CI: -0.25, 0.07) from pre- to post-intervention in the exercise arm (p = 0.14) and increased (0.08 mg/dL, 95 % CI: -0.07, 0.24) (p = 0.64) in the health and wellness arm; however the between group difference was not statistically significant (p = 0.14). Findings did not differ according to ethnic group or pre-pregnancy body mass index. In a secondary analysis based on self-reported physical activity, women who decreased their time spent in sports/exercise experienced a mean increase in CRP (0.09 mg/dL, 95 % CI: -0.14, 0.33), whereas women who maintained or increased their sports/ exercise experienced a mean decrease in CRP (-0.08 mg/dL, 95 % CI: -0.23, 0.08) (p = 0.046). Findings from this randomized trial in an ethnically and socio-economically diverse population of pregnant women were consistent with a positive impact

Influence of a New “Call-Out Algorithm” for Management of Postoperative Pain and Its Side Effects on Length of Stay in Hospital: A Two-Centre Prospective Randomized Trial

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Dybvik, Lisa; Skraastad, Erlend; Yeltayeva, Aigerim; Konkayev, Aidos; Musaeva, Tatiana; Zabolotskikh, Igor; Dahl, Vegard; Raeder, Johan

2017-01-01

Background We recently introduced the efficacy safety score (ESS) as a new “call-out algorithm” for management of postoperative pain and side effects. In this study, we report the influence of ESS recorded hourly during the first 8 hours after surgery on the mobility degree, postoperative nonsurgical complications, and length of hospital stay (LOS). Methods We randomized 1152 surgical patients into three groups for postoperative observation: (1) ESS group (n = 409), (2) Verbal Numeric Rate Scale (VNRS) for pain group (n = 417), and (3) an ordinary qualitative observation (Control) group (n = 326). An ESS > 10 or VNRS > 4 at rest or a nurse's observation of pain or adverse reaction to analgesic treatment in the Control group served as a “call-out alarm” for an anaesthesiologist. Results We found no significant differences in the mobility degree and number of postoperative nonsurgical complications between the groups. LOS was significantly shorter with 12.7 ± 6.3 days (mean ± SD) in the ESS group versus 14.2 ± 6.2 days in the Control group (P < 0.001). Conclusion Postoperative ESS recording in combination with the possibility to call upon an anaesthesiologist when exceeding the threshold score might have contributed to the reductions of LOS in this two-centre study. This trial is registered with NCT02143128. PMID:28855800

Influence of a New “Call-Out Algorithm” for Management of Postoperative Pain and Its Side Effects on Length of Stay in Hospital: A Two-Centre Prospective Randomized Trial

Directory of Open Access Journals (Sweden)

Lisa Dybvik

2017-01-01

Full Text Available Background. We recently introduced the efficacy safety score (ESS as a new “call-out algorithm” for management of postoperative pain and side effects. In this study, we report the influence of ESS recorded hourly during the first 8 hours after surgery on the mobility degree, postoperative nonsurgical complications, and length of hospital stay (LOS. Methods. We randomized 1152 surgical patients into three groups for postoperative observation: (1 ESS group (n=409, (2 Verbal Numeric Rate Scale (VNRS for pain group (n=417, and (3 an ordinary qualitative observation (Control group (n=326. An ESS > 10 or VNRS > 4 at rest or a nurse’s observation of pain or adverse reaction to analgesic treatment in the Control group served as a “call-out alarm” for an anaesthesiologist. Results. We found no significant differences in the mobility degree and number of postoperative nonsurgical complications between the groups. LOS was significantly shorter with 12.7±6.3 days (mean ± SD in the ESS group versus 14.2±6.2 days in the Control group (P<0.001. Conclusion. Postoperative ESS recording in combination with the possibility to call upon an anaesthesiologist when exceeding the threshold score might have contributed to the reductions of LOS in this two-centre study. This trial is registered with NCT02143128.

A Randomized Controlled Trial Determining Variances in Ostomy Skin Conditions and the Economic Impact (ADVOCATE Trial).

Science.gov (United States)

Colwell, Janice C; Pittman, Joyce; Raizman, Rose; Salvadalena, Ginger

To compare ostomy-related costs and incidence of peristomal skin complications (PSCs) for ceramide-infused ostomy skin barriers and control skin barriers. The ADVOCATE trial is a multi-centered randomized controlled trial, and double-blinded international study with an adaptive design. The sample comprised 153 adults from 25 sites from the United States, Canada, and Europe. Participants were seen in hospital and outpatient care settings. Data were collected by investigators at each site during face-to-face visits and during telephone check-in calls between visits. Cost of care data were collected using a questionnaire developed specifically for the study. The peristomal skin was assessed using the Ostomy Skin Tool. Health-related quality of life was measured using the SF-12v2. Patient-reported outcomes were collected using a patient-centered study-specific questionnaire. Cost of care was analyzed via analysis of covariance comparing total cost of care for 12 weeks between the 2 groups. The incidence of PSC was analyzed via Barnard's exact test comparing the incidence of PSCs between the control and treatment groups. Tertiary outcomes were exploratory in nature and not statistically powered. Use of the ceramide-infused barrier significantly reduced stoma-related cost of care over a 12-week period, resulting in a $36.46 decrease in cost (14% relative decrease). The adjusted average costs were $223.73 in the treatment group and $260.19 in the control group (P = .017). The overall incidence of PSCs in the study was 47.7%; PSC incidence was 40.5% for the treatment group versus 55.4% for controls (P = .069, 95% confidence interval of the difference: -1.2 to 30.4). Significantly more participants using the ceramide-infused skin barrier were "very satisfied" with barrier performance (75% vs 55%; P = .033), prevention of leakage (63% vs 38%; P < .01), and prevention of itching (53% vs 31%; P = .016). General postoperative improvement in health-related quality of life was

Stepwise strategy to improve Cervical Cancer Screening Adherence (SCAN-CC): automated text messages, phone calls and face-to-face interviews: protocol of a population-based randomised controlled trial.

Science.gov (United States)

Firmino-Machado, João; Mendes, Romeu; Moreira, Amélia; Lunet, Nuno

2017-10-05

Screening is highly effective for cervical cancer prevention and control. Population-based screening programmes are widely implemented in high-income countries, although adherence is often low. In Portugal, just over half of the women adhere to cervical cancer screening, contributing for greater mortality rates than in other European countries. The most effective adherence raising strategies are based on patient reminders, small/mass media and face-to-face educational programmes, but sequential interventions targeting the general population have seldom been evaluated. The aim of this study is to assess the effectiveness of a stepwise approach, with increasing complexity and cost, to improve adherence to organised cervical cancer screening: step 1a-customised text message invitation; step 1b-customised automated phone call invitation; step 2-secretary phone call; step 3-family health professional phone call and face-to-face appointment. A population-based randomised controlled trial will be implemented in Portuguese urban and rural areas. Women eligible for cervical cancer screening will be randomised (1:1) to intervention and control. In the intervention group, women will be invited for screening through text messages, automated phone calls, manual phone calls and health professional appointments, to be applied sequentially to participants remaining non-adherent after each step. Control will be the standard of care (written letter). The primary outcome is the proportion of women adherent to screening after step 1 or sequences of steps from 1 to 3. The secondary outcomes are: proportion of women screened after each step (1a, 2 and 3); proportion of text messages/phone calls delivered; proportion of women previously screened in a private health institution who change to organised screening. The intervention and control groups will be compared based on intention-to-treat and per-protocol analyses. The study was approved by the Ethics Committee of the Northern Health

Pragmatic trial design elements showed a different impact on trial interpretation and feasibility than explanatory elements

NARCIS (Netherlands)

Nieuwenhuis, Joost B.; Irving, Elaine; Oude Rengerink, Katrien; Lloyd, Emily; Goetz, Iris; Grobbee, Diederick E.; Stolk, Pieter; Groenwold, Rolf H H; Zuidgeest, Mira G P

2016-01-01

OBJECTIVE: To illustrate how pragmatic trial design elements, or inserting explanatory trial elements in pragmatic trials affect validity, generalizability, precision and operational feasibility. STUDY DESIGN AND SETTING: From illustrative examples identified through the IMI Get Real Consortium, we

Methodology Series Module 4: Clinical Trials.

Science.gov (United States)

Setia, Maninder Singh

2016-01-01

In a clinical trial, study participants are (usually) divided into two groups. One group is then given the intervention and the other group is not given the intervention (or may be given some existing standard of care). We compare the outcomes in these groups and assess the role of intervention. Some of the trial designs are (1) parallel study design, (2) cross-over design, (3) factorial design, and (4) withdrawal group design. The trials can also be classified according to the stage of the trial (Phase I, II, III, and IV) or the nature of the trial (efficacy vs. effectiveness trials, superiority vs. equivalence trials). Randomization is one of the procedures by which we allocate different interventions to the groups. It ensures that all the included participants have a specified probability of being allocated to either of the groups in the intervention study. If participants and the investigator know about the allocation of the intervention, then it is called an "open trial." However, many of the trials are not open - they are blinded. Blinding is useful to minimize bias in clinical trials. The researcher should familiarize themselves with the CONSORT statement and the appropriate Clinical Trials Registry of India.

On-call work: To sleep or not to sleep? It depends.

Science.gov (United States)

Ferguson, Sally A; Paterson, Jessica L; Hall, Sarah J; Jay, Sarah M; Aisbett, Brad

On-call working time arrangements are increasingly common, involve work only in the event of an unpredictable incident and exist primarily outside of standard hours. Like other non-standard working time arrangements, on-call work disrupts sleep and can therefore have negative effects on health, safety and performance. Unlike other non-standard working time arrangements, on-call work often allows sleep opportunities between calls. Any sleep obtained during on-call periods will be beneficial for waking performance. However, there is evidence that sleep while on call may be of substantially reduced restorative value because of the expectation of receiving the call and apprehension about missing the call. In turn, waking from sleep to respond to a call may be associated with temporary increases in performance impairment. This is dependent on characteristics of both the preceding sleep, the tasks required upon waking and the availability and utility of any countermeasures to support the transition from sleep to wake. In this paper, we critically evaluate the evidence both for and against sleeping during on-call periods and conclude that some sleep, even if it is of reduced quality and broken by repeated calls, is a good strategy. We also note, however, that organisations utilising on-call working time arrangements need to systematically manage the likelihood that on-call sleep can be associated with temporary performance impairments upon waking. Given that the majority of work in this area has been laboratory-based, there is a significant need for field-based investigations of the magnitude of sleep inertia, in addition to the utility of sleep inertia countermeasures. Field studies should include working with subject matter experts to identify the real-world impacts of changes in performance associated with sleeping, or not sleeping, whilst on call.

Condoms and sexual health education as evidence: impact of criminalization of in-call venues and managers on migrant sex workers access to HIV/STI prevention in a Canadian setting.

Science.gov (United States)

Anderson, S; Shannon, K; Li, J; Lee, Y; Chettiar, J; Goldenberg, S; Krüsi, A

2016-11-17

Despite a large body of evidence globally demonstrating that the criminalization of sex workers increases HIV/STI risks, we know far less about the impact of criminalization and policing of managers and in-call establishments on HIV/STI prevention among sex workers, and even less so among migrant sex workers. Analysis draws on ethnographic fieldwork and 46 qualitative interviews with migrant sex workers, managers and business owners of in-call sex work venues in Metro Vancouver, Canada. The criminalization of in-call venues and third parties explicitly limits sex workers' access to HIV/STI prevention, including manager restrictions on condoms and limited onsite access to sexual health information and HIV/STI testing. With limited labour protections and socio-cultural barriers, criminalization and policing undermine the health and human rights of migrant sex workers working in -call venues. This research supports growing evidence-based calls for decriminalization of sex work, including the removal of criminal sanctions targeting third parties and in-call venues, alongside programs and policies that better protect the working conditions of migrant sex workers as critical to HIV/STI prevention and human rights.

The impact of post-discharge patient call back on patient satisfaction in two academic emergency departments.

Science.gov (United States)

Guss, David A; Leland, Hyuma; Castillo, Edward M

2013-01-01

Patients' satisfaction is a common parameter tracked by health care systems and Emergency Departments (EDs). To determine whether telephone calls by health care providers to patients after discharge from the ED was associated with improved patient satisfaction. Retrospective analysis of Press Ganey (PG; Press Ganey Associates, South Bend, IN) surveys from two EDs operated by the University of California San Diego Health System. Responses to the YES/NO question, "After discharge, did you receive a phone call from an ED staff member?" was compared to the responses to the question "likelihood of recommending this ED to others" (LR). This variable could be ranked with a score of 1 (very poor) to 5 (very good). Responses were dichotomized into two groups, 1-4 and 5. Chi-squared was performed to assess LR between those answering YES vs. NO to the call back question. Differences in proportion, 95% confidence interval (CI), and p-value are reported. Rankings for percentage of 5s across all EDs in the PG database were compared based upon YES/NO responses. In the 12-month study period, about 30,000 surveys were mailed and 2250 (7.5%) were returned. Three hundred forty-seven (15.4%) checked off YES for the call back question. Percentage of 5s for LR for NO call back was 51.1% and for YES call back was 70.6% (difference = 19.5; 95% CI 14.0-24.6; p < 0.001).These values correlated with an ED ranking of 14(th) and 85(th) percentile, respectively. This retrospective study demonstrated a strong association between post-visit patient call back and LR. Further prospective study with control for co-variables is warranted. Copyright © 2013 Elsevier Inc. All rights reserved.

Call for another special issue / book

Science.gov (United States)

Bostenaru Dan, M.

2009-04-01

We would like to continue the series of special issue or maybe edit a book on this topic. To complete the formerly edited special issues we would like to link natural hazards research to cultural heritage research. We see a way of doing this connected to "integrated conservation", which sees the involvment of urban planning in conservation, as well as the (urban) sociology, the integration of the user, the participatism. We further call for investigation of GIS applications for the investigation of natural hazards' impact in this field. We are open for further ideas and wait for you at the Splinter meeting.

Pairing call-response surveys and distance sampling for a mammalian carnivore

Science.gov (United States)

Hansen, Sara J. K.; Frair, Jacqueline L.; Underwood, Harold B.; Gibbs, James P.

2015-01-01

Density estimates accounting for differential animal detectability are difficult to acquire for wide-ranging and elusive species such as mammalian carnivores. Pairing distance sampling with call-response surveys may provide an efficient means of tracking changes in populations of coyotes (Canis latrans), a species of particular interest in the eastern United States. Blind field trials in rural New York State indicated 119-m linear error for triangulated coyote calls, and a 1.8-km distance threshold for call detectability, which was sufficient to estimate a detection function with precision using distance sampling. We conducted statewide road-based surveys with sampling locations spaced ≥6 km apart from June to August 2010. Each detected call (be it a single or group) counted as a single object, representing 1 territorial pair, because of uncertainty in the number of vocalizing animals. From 524 survey points and 75 detections, we estimated the probability of detecting a calling coyote to be 0.17 ± 0.02 SE, yielding a detection-corrected index of 0.75 pairs/10 km2 (95% CI: 0.52–1.1, 18.5% CV) for a minimum of 8,133 pairs across rural New York State. Importantly, we consider this an index rather than true estimate of abundance given the unknown probability of coyote availability for detection during our surveys. Even so, pairing distance sampling with call-response surveys provided a novel, efficient, and noninvasive means of monitoring populations of wide-ranging and elusive, albeit reliably vocal, mammalian carnivores. Our approach offers an effective new means of tracking species like coyotes, one that is readily extendable to other species and geographic extents, provided key assumptions of distance sampling are met.

The impact of product information and trials on demand for smokeless tobacco and cigarettes: evidence from experimental auctions.

Science.gov (United States)

Rousu, Matthew C; O'Connor, Richard J; Thrasher, James F; June, Kristie M; Bansal-Travers, Maansi; Pitcavage, James

2014-03-01

Epidemiological and toxicological evidence suggests lower risk of smokeless tobacco (ST) products compared to cigarettes. Less is known, however, about consumer perceptions and use of novel forms of ST, including snus and dissolvable tobacco. In this study, we conducted in-person experimental auctions in Buffalo, NY, Columbia, SC, and Selinsgrove, PA with 571 smokers to test the impact of information and product trials on smokers' preferences. Auctions were conducted between November 2010-November 2011. We found no evidence of an impact of product trials on demand in our auctions. Anti-ST information increased demand for cigarettes when presented alone, but when presented with pro-ST information it decreased demand for cigarettes. It did not decrease demand for ST products. Anti-smoking information increased demand for ST products, but did not affect cigarette demand. These findings suggest that credible and effective communications about tobacco harm reduction should reinforce the negative effects of smoking. Copyright © 2013 Elsevier Inc. All rights reserved.

Impact of Exposure to Electronic Cigarette Advertising on Susceptibility and Trial of Electronic Cigarettes and Cigarettes in US Young Adults: A Randomized Controlled Trial.

Science.gov (United States)

Villanti, Andrea C; Rath, Jessica M; Williams, Valerie F; Pearson, Jennifer L; Richardson, Amanda; Abrams, David B; Niaura, Raymond S; Vallone, Donna M

2016-05-01

This study assessed the impact of brief exposure to four electronic cigarette (e-cigarette) print advertisements (ads) on perceptions, intention, and subsequent use of e-cigarettes and cigarettes in US young adults. A randomized controlled trial was conducted in a national sample of young adults from an online panel survey in 2013. Participants were randomized to ad exposure or control. Curiosity, intentions, and perceptions regarding e-cigarettes were assessed post-exposure and e-cigarette and cigarette use at 6-month follow-up. Analyses were conducted in 2014. Approximately 6% of young adults who had never used an e-cigarette at baseline tried an e-cigarette at 6-month follow-up, half of whom were current cigarette smokers at baseline. Compared to the control group, ad exposure was associated with greater curiosity to try an e-cigarette (18.3% exposed vs. 11.3% unexposed, AOR = 1.63, 95% CI = 1.18, 2.26) among never e-cigarette users and greater likelihood of e-cigarette trial at follow-up (3.6% exposed vs. 1.2% unexposed, AOR = 2.85; 95% CI = 1.07, 7.61) among never users of cigarettes and e-cigarettes. Exploratory analyses did not find an association between ad exposure and cigarette trial or past 30-day use among never users, nor cigarette use among smokers over time. Curiosity mediated the relationship between ad exposure and e-cigarette trial among e-cigarette never users. Exposure to e-cigarette ads may enhance curiosity and limited trial of e-cigarettes in never users. Future studies are needed to examine the net effect of curiosity and trial of e-cigarettes on longer-term patterns of tobacco use. This randomized trial provides the first evidence of the effect of e-cigarette advertising on a behavioral outcome in young adults. Compared to the control group, ad exposure was associated with greater curiosity to try an e-cigarette among never e-cigarette users and greater likelihood of e-cigarette trial at follow-up in a small number of never e

Methodology series module 4: Clinical trials

Directory of Open Access Journals (Sweden)

Maninder Singh Setia

2016-01-01

Full Text Available In a clinical trial, study participants are (usually divided into two groups. One group is then given the intervention and the other group is not given the intervention (or may be given some existing standard of care. We compare the outcomes in these groups and assess the role of intervention. Some of the trial designs are (1 parallel study design, (2 cross-over design, (3 factorial design, and (4 withdrawal group design. The trials can also be classified according to the stage of the trial (Phase I, II, III, and IV or the nature of the trial (efficacy vs. effectiveness trials, superiority vs. equivalence trials. Randomization is one of the procedures by which we allocate different interventions to the groups. It ensures that all the included participants have a specified probability of being allocated to either of the groups in the intervention study. If participants and the investigator know about the allocation of the intervention, then it is called an "open trial." However, many of the trials are not open - they are blinded. Blinding is useful to minimize bias in clinical trials. The researcher should familiarize themselves with the CONSORT statement and the appropriate Clinical Trials Registry of India.

Perceiving a calling, living a calling, and job satisfaction: testing a moderated, multiple mediator model.

Science.gov (United States)

Duffy, Ryan D; Bott, Elizabeth M; Allan, Blake A; Torrey, Carrie L; Dik, Bryan J

2012-01-01

The current study examined the relation between perceiving a calling, living a calling, and job satisfaction among a diverse group of employed adults who completed an online survey (N = 201). Perceiving a calling and living a calling were positively correlated with career commitment, work meaning, and job satisfaction. Living a calling moderated the relations of perceiving a calling with career commitment and work meaning, such that these relations were more robust for those with a stronger sense they were living their calling. Additionally, a moderated, multiple mediator model was run to examine the mediating role of career commitment and work meaning in the relation of perceiving a calling and job satisfaction, while accounting for the moderating role of living a calling. Results indicated that work meaning and career commitment fully mediated the relation between perceiving a calling and job satisfaction. However, the indirect effects of work meaning and career commitment were only significant for individuals with high levels of living a calling, indicating the importance of living a calling in the link between perceiving a calling and job satisfaction. Implications for research and practice are discussed. (c) 2012 APA, all rights reserved.

Call Center Capacity Planning

DEFF Research Database (Denmark)

Nielsen, Thomas Bang

in order to relate the results to the service levels used in call centers. Furthermore, the generic nature of the approximation is demonstrated by applying it to a system incorporating a dynamic priority scheme. In the last paper Optimization of overflow policies in call centers, overflows between agent......The main topics of the thesis are theoretical and applied queueing theory within a call center setting. Call centers have in recent years become the main means of communication between customers and companies, and between citizens and public institutions. The extensively computerized infrastructure...... in modern call centers allows for a high level of customization, but also induces complicated operational processes. The size of the industry together with the complex and labor intensive nature of large call centers motivates the research carried out to understand the underlying processes. The customizable...

Impact of Family History Assessment on Communication with Family Members and Health Care Providers: A report from the Family Healthware™ Impact Trial (FHITr)

Science.gov (United States)

Wang, Catharine; Sen, Ananda; Plegue, Melissa; Ruffin, Mack T.; O'Neill, Suzanne M.; Rubinstein, Wendy S.; Acheson, Louise S.

2015-01-01

Objective This study examines the impact of Family Healthware™ on communication behaviors; specifically, communication with family members and health care providers about family health history. Methods A total of 3786 participants were enrolled in the Family Healthware™ Impact Trial (FHITr) in the United States from 2005-7. The trial employed a two-arm cluster-randomized design, with primary care practices serving as the unit of randomization. Using generalized estimating equations (GEE), analyses focused on communication behaviors at 6 month follow-up, adjusting for age, site and practice clustering. Results A significant interaction was observed between study arm and baseline communication status for the family communication outcomes (psfamily members about family history risk (OR=1.24, p=0.042) and actively collecting family history information at follow-up (OR=2.67, p=0.026). Family Healthware™ did not have a significant effect on family communication among those already communicating at baseline, or on provider communication, regardless of baseline communication status. Greater communication was observed among those at increased familial risk for a greater number of diseases. Conclusion Family Healthware™ prompted more communication about family history with family members, among those who were not previously communicating. Efforts are needed to identify approaches to encourage greater sharing of family history information, particularly with health care providers. PMID:25901453

Language teacher education in CALL: history and perspectives

Directory of Open Access Journals (Sweden)

Ana Cristina Biondo Salomão

2013-01-01

Full Text Available Over the last years, the new technologies have changed the way we relate to information and communicate with other people, which has brought on impact to foreign language teaching and learning, and, consequently, to the area of foreign language teacher education. The abbreviation CALL (Computer Assisted Language Learning has been used to designate the processes of language teaching and learning with the use of computers, and language teacher education in CALL to name teacher education for and with the use of new technologies, since a number of authors point to the interdependence of both processes. We intend in this article to present an overview of the literature of the area of language teacher education in CALL nowadays and discuss issues related to the use of new technologies concerning its integration to teacher education and the functional and institutional roles to be taken. We also present two proposals of teacher education with the use of new technologies which are being implemented and at the same time studied in Brazil, which we believe have essential elements for the development of language teachers for and with the use of new technologies currently.

Calle Blanco

Directory of Open Access Journals (Sweden)

Gonzalo Cerda Brintrup

1988-06-01

Full Text Available Importante arteria, que comunica el sector del puerto con la plaza. Las más imponentes construcciones se sucedían de un modo continuo, encaramándose a ambos lados de la empinada calle. Antes del gran incendio de 1936 grandes casonas de madera destacaban en calle Irarrázabal y en la esquina de ésta con calle Blanco, la más hermosa construcción pertenecía a don Alberto Oyarzún y la casa vecina hacia Blanco era de don Mateo Miserda, limitada por arriba con la casa de don Augusto Van Der Steldt y ésta era seguida de la casa de don David Barrientos provista de cuatro cúpulas en las esquinas y de un amplio corredor en el frontis. Todas estas construcciones de madera fueron destruidas en el gran incendio de 1936.

Randomized trials published in higher vs. lower impact journals differ in design, conduct, and analysis.

Science.gov (United States)

Bala, Malgorzata M; Akl, Elie A; Sun, Xin; Bassler, Dirk; Mertz, Dominik; Mejza, Filip; Vandvik, Per Olav; Malaga, German; Johnston, Bradley C; Dahm, Philipp; Alonso-Coello, Pablo; Diaz-Granados, Natalia; Srinathan, Sadeesh K; Hassouneh, Basil; Briel, Matthias; Busse, Jason W; You, John J; Walter, Stephen D; Altman, Douglas G; Guyatt, Gordon H

2013-03-01

To compare methodological characteristics of randomized controlled trials (RCTs) published in higher vs. lower impact Core Clinical Journals. We searched MEDLINE for RCTs published in 2007 in Core Clinical Journals. We randomly sampled 1,140 study reports in a 1:1 ratio in higher (five general medicine journals with the highest total citations in 2007) and lower impact journals. Four hundred sixty-nine RCTs proved eligible: 219 in higher and 250 in lower impact journals. RCTs in higher vs. lower impact journals had larger sample sizes (median, 285 vs. 39), were more likely to receive industry funding (53% vs. 28%), declare concealment of allocation (66% vs. 36%), declare blinding of health care providers (53% vs. 41%) and outcome adjudicators (72% vs. 54%), report a patient-important primary outcome (69% vs. 50%), report subgroup analyses (64% vs. 26%), prespecify subgroup hypotheses (42% vs. 20%), and report a test for interaction (54% vs. 27%); P journals were more likely to report methodological safeguards against bias and patient-important outcomes than those published in lower impact journals. However, sufficient limitations remain such that publication in a higher impact journal does not ensure low risk of bias. Copyright © 2013 Elsevier Inc. All rights reserved.

Impact of a deferred recruitment model in a randomised controlled trial in primary care (CREAM study).

Science.gov (United States)

Shepherd, Victoria; Thomas-Jones, Emma; Ridd, Matthew J; Hood, Kerenza; Addison, Katy; Francis, Nick A

2017-11-10

Recruitment of participants is particularly challenging in primary care, with less than a third of randomised controlled trials (RCT) achieving their target within the original time frame. Participant identification, consent, randomisation and data collection can all be time-consuming. Trials recruiting an incident, as opposed to a prevalent, population may be particularly affected. This paper describes the impact of a deferred recruitment model in a RCT of antibiotics for children with infected eczema in primary care, which required the recruitment of cases presenting acutely. Eligible children were identified by participating general practitioners (GPs) and referred to a study research nurse, who then visited them at home. This allowed the consent and recruitment processes to take place outside the general practice setting. Information was recorded about patients who were referred and recruited, or if not, the reasons for non-recruitment. Data on recruitment challenges were collected through semi-structured interviews and questionnaires with a sample of participating GPs. Data were thematically analysed to identify key themes. Of the children referred to the study 34% (58/171) were not recruited - 48% (28/58) because of difficulties arranging a baseline visit within the defined time frame, 31% (18/58) did not meet the study inclusion criteria at the time of nurse assessment, and 21% (12/58) declined participation. GPs had positive views about the recruitment process, reporting that parents valued and benefitted from additional contact with a nurse. GPs felt that the deferred recruitment model did not negatively impact on the study. GPs and parents recognised the benefits of deferred recruitment, but these did not translate into enhanced recruitment of participants. The model resulted in the loss of a third of children who were identified by the GP as eligible, but not subsequently recruited to the study. If the potential for improving outcomes in primary care

Errors in self-reports of health services use: impact on alzheimer disease clinical trial designs.

Science.gov (United States)

Callahan, Christopher M; Tu, Wanzhu; Stump, Timothy E; Clark, Daniel O; Unroe, Kathleen T; Hendrie, Hugh C

2015-01-01

Most Alzheimer disease clinical trials that compare the use of health services rely on reports of caregivers. The goal of this study was to assess the accuracy of self-reports among older adults with Alzheimer disease and their caregiver proxy respondents. This issue is particularly relevant to Alzheimer disease clinical trials because inaccuracy can lead both to loss of power and increased bias in study outcomes. We compared respondent accuracy in reporting any use and in reporting the frequency of use with actual utilization data as documented in a comprehensive database. We next simulated the impact of underreporting and overreporting on sample size estimates and treatment effect bias for clinical trials comparing utilization between experimental groups. Respondents self-reports have a poor level of accuracy with κ-values often below 0.5. Respondents tend to underreport use even for rare events such as hospitalizations and nursing home stays. In analyses simulating underreporting and overreporting of varying magnitude, we found that errors in self-reports can increase the required sample size by 15% to 30%. In addition, bias in the reported treatment effect ranged from 3% to 18% due to both underreporting and overreporting errors. Use of self-report data in clinical trials of Alzheimer disease treatments may inflate sample size needs. Even when adequate power is achieved by increasing sample size, reporting errors can result in a biased estimate of the true effect size of the intervention.

High call volume at poison control centers: identification and implications for communication.

Science.gov (United States)

Caravati, E M; Latimer, S; Reblin, M; Bennett, H K W; Cummins, M R; Crouch, B I; Ellington, L

2012-09-01

High volume surges in health care are uncommon and unpredictable events. Their impact on health system performance and capacity is difficult to study. To identify time periods that exhibited very busy conditions at a poison control center and to determine whether cases and communication during high volume call periods are different from cases during low volume periods. Call data from a US poison control center over twelve consecutive months was collected via a call logger and an electronic case database (Toxicall®).Variables evaluated for high call volume conditions were: (1) call duration; (2) number of cases; and (3) number of calls per staff member per 30 minute period. Statistical analyses identified peak periods as busier than 99% of all other 30 minute time periods and low volume periods as slower than 70% of all other 30 minute periods. Case and communication characteristics of high volume and low volume calls were compared using logistic regression. A total of 65,364 incoming calls occurred over 12 months. One hundred high call volume and 4885 low call volume 30 minute periods were identified. High volume periods were more common between 1500 and 2300 hours and during the winter months. Coded verbal communication data were evaluated for 42 high volume and 296 low volume calls. The mean (standard deviation) call length of these calls during high volume and low volume periods was 3 minutes 27 seconds (1 minute 46 seconds) and 3 minutes 57 seconds (2 minutes 11 seconds), respectively. Regression analyses revealed a trend for fewer overall verbal statements and fewer staff questions during peak periods, but no other significant differences for staff-caller communication behaviors were found. Peak activity for poison center call volume can be identified by statistical modeling. Calls during high volume periods were similar to low volume calls. Communication was more concise yet staff was able to maintain a good rapport with callers during busy call periods

Tailored approaches to stroke health education (TASHE): study protocol for a randomized controlled trial.

Science.gov (United States)

Ravenell, Joseph; Leighton-Herrmann, Ellyn; Abel-Bey, Amparo; DeSorbo, Alexandra; Teresi, Jeanne; Valdez, Lenfis; Gordillo, Madeleine; Gerin, William; Hecht, Michael; Ramirez, Mildred; Noble, James; Cohn, Elizabeth; Jean-Louis, Giardin; Spruill, Tanya; Waddy, Salina; Ogedegbe, Gbenga; Williams, Olajide

2015-04-19

Stroke is a leading cause of adult disability and mortality. Intravenous thrombolysis can minimize disability when patients present to the emergency department for treatment within the 3 - 4½ h of symptom onset. Blacks and Hispanics are more likely to die and suffer disability from stroke than whites, due in part to delayed hospital arrival and ineligibility for intravenous thrombolysis for acute stroke. Low stroke literacy (poor knowledge of stroke symptoms and when to call 911) among Blacks and Hispanics compared to whites may contribute to disparities in acute stroke treatment and outcomes. Improving stroke literacy may be a critical step along the pathway to reducing stroke disparities. The aim of the current study is to test a novel intervention to increase stroke literacy in minority populations in New York City. In a two-arm cluster randomized trial, we will evaluate the effectiveness of two culturally tailored stroke education films - one in English and one in Spanish - on changing behavioral intent to call 911 for suspected stroke, compared to usual care. These films will target knowledge of stroke symptoms, the range of severity of symptoms and the therapeutic benefit of calling 911, as well as address barriers to timely presentation to the hospital. Given the success of previous church-based programs targeting behavior change in minority populations, this trial will be conducted with 250 congregants across 14 churches (125 intervention; 125 control). Our proposed outcomes are (1) recognition of stroke symptoms and (2) behavioral intent to call 911 for suspected stroke, measured using the Stroke Action Test at the 6-month and 1-year follow-up. This is the first randomized trial of a church-placed narrative intervention to improve stroke outcomes in urban Black and Hispanic populations. A film intervention has the potential to make a significant public health impact, as film is a highly scalable and disseminable medium. Since there is at least one

Are reports of randomized controlled trials improving over time? A systematic review of 284 articles published in high-impact general and specialized medical journals.

Science.gov (United States)

To, Matthew J; Jones, Jennifer; Emara, Mohamed; Jadad, Alejandro R

2013-01-01

Inadequate reporting undermines findings of randomized controlled trials (RCTs). This study assessed and compared articles published in high-impact general medical and specialized journals. Reports of RCTs published in high-impact general and specialized medical journals were identified through a search of MEDLINE from January to March of 1995, 2000, 2005, and 2010. Articles that provided original data on adult patients diagnosed with chronic conditions were included in the study. Data on trial characteristics, reporting of allocation concealment, quality score, and the presence of a trial flow diagram were extracted independently by two reviewers, and discrepancies were resolved by consensus or independent adjudication. Descriptive statistics were used for quantitative variables. Comparisons between general medical and specialized journals, and trends over time were performed using Chi-square tests. Reports of 284 trials were analyzed. There was a significantly higher proportion of RCTs published with adequate reporting of allocation concealment (p = 0.003), presentation of a trial flow diagram (pgeneral medical journals had higher quality scores than those in specialized journals (p = 0.001), reported adequate allocation concealment more often (p = 0.013), and presented a trial flow diagram more often (pjournals over the last fifteen years. These improvements are likely attributed to concerted international efforts to improve reporting quality such as CONSORT. There is still much room for improvement, especially among specialized journals.

Inherited Retinal Degenerative Clinical Trial Network

Science.gov (United States)

2009-10-01

clinical efforts that will impact the NEER network going forward and laid the ground work for the CTECs to participate in ongoing clinical trials for...Clinical Implications: • How will the proposed clinical trial have a significant impact on disease outcome? 34 • How will the clinical trial offer...was 0 041U>< for pat<t!nts NPtS and <H08, 0 4 1ux !01 Ct 110, 1nd 10.0 lux f01 < H13 OJ)Ilo •her on~tion are indiuttd AhtrNtor19 stimuli Wl’f1! pres

Reporting quality of randomised controlled trial abstracts among high-impact general medical journals: a review and analysis.

Science.gov (United States)

Hays, Meredith; Andrews, Mary; Wilson, Ramey; Callender, David; O'Malley, Patrick G; Douglas, Kevin

2016-07-28

The aim of this study was to assess adherence to the Consolidated Standards of Reporting Trials (CONSORT) for Abstracts by five high-impact general medical journals and to assess whether the quality of reporting was homogeneous across these journals. This is a descriptive, cross-sectional study. Randomised controlled trial (RCT) abstracts in five high-impact general medical journals. We used up to 100 RCT abstracts published between 2011 and 2014 from each of the following journals: The New England Journal of Medicine (NEJM), the Annals of Internal Medicine (Annals IM), The Lancet, the British Medical Journal (The BMJ) and the Journal of the American Medical Association (JAMA). The primary outcome was per cent overall adherence to the 19-item CONSORT for Abstracts checklist. Secondary outcomes included per cent adherence in checklist subcategories and assessing homogeneity of reporting quality across the individual journals. Search results yielded 466 abstracts, 3 of which were later excluded as they were not RCTs. Analysis was performed on 463 abstracts (97 from NEJM, 66 from Annals IM, 100 from The Lancet, 100 from The BMJ, 100 from JAMA). Analysis of all scored items showed an overall adherence of 67% (95% CI 66% to 68%) to the CONSORT for Abstracts checklist. The Lancet had the highest overall adherence rate (78%; 95% CI 76% to 80%), whereas NEJM had the lowest (55%; 95% CI 53% to 57%). Adherence rates to 8 of the checklist items differed by >25% between journals. Among the five highest impact general medical journals, there is variable and incomplete adherence to the CONSORT for Abstracts reporting checklist of randomised trials, with substantial differences between individual journals. Lack of adherence to the CONSORT for Abstracts reporting checklist by high-impact medical journals impedes critical appraisal of important studies. We recommend diligent assessment of adherence to reporting guidelines by authors, reviewers and editors to promote transparency

Perceiving a Calling, Living a Calling, and Job Satisfaction: Testing a Moderated, Multiple Mediator Model

Science.gov (United States)

Duffy, Ryan D.; Bott, Elizabeth M.; Allan, Blake A.; Torrey, Carrie L.; Dik, Bryan J.

2012-01-01

The current study examined the relation between perceiving a calling, living a calling, and job satisfaction among a diverse group of employed adults who completed an online survey (N = 201). Perceiving a calling and living a calling were positively correlated with career commitment, work meaning, and job satisfaction. Living a calling moderated…

Behavioral Preferences for Individual Securities : The Case for Call Warrants and Call Options

NARCIS (Netherlands)

Ter Horst, J.R.; Veld, C.H.

2002-01-01

Since 1998, large investment banks have flooded the European capital markets with issues of call warrants.This has led to a unique situation in the Netherlands, where now call warrants, traded on the stock exchange, and long-term call options, traded on the options exchange, exist.Both entitle their

Modelling spatial trends in sorghum breeding field trials using a two-dimensional P-spline mixed model

NARCIS (Netherlands)

J.G. Velazco (Julio G.); M.X. Rodríguez-Álvarez (María Xosé); M.P. Boer (Martin); D.R. Jordan (David R.); P.H.C. Eilers (Paul); M. Malosetti (Marcos); F. van Eeuwijk (Fred)

2017-01-01

markdownabstract_Key message: A flexible and user-friendly spatial method called SpATS performed comparably to more elaborate and trial-specific spatial models in a series of sorghum breeding trials._ __Abstract:__ Adjustment for spatial trends in plant breeding field trials is essential for

The impact of financial incentives on participants' food purchasing patterns in a supermarket-based randomized controlled trial.

Science.gov (United States)

Olstad, Dana Lee; Crawford, David A; Abbott, Gavin; McNaughton, Sarah A; Le, Ha Nd; Ni Mhurchu, Cliona; Pollard, Christina; Ball, Kylie

2017-08-25

The impacts of supermarket-based nutrition promotion interventions might be overestimated if participants shift their proportionate food purchasing away from their usual stores. This study quantified whether participants who received price discounts on fruits and vegetables (FV) in the Supermarket Healthy Eating for Life (SHELf) randomized controlled trial (RCT) shifted their FV purchasing into study supermarkets during the intervention period. Participants were 642 females randomly assigned to a 1) skill-building (n = 160), 2) price reduction (n = 161), 3) combined skill-building and price reduction (n = 160), or 4) control (n = 161) group. Participants self-reported the proportion of FV purchased in study supermarkets at baseline, 3- and 6-months post-intervention. Fisher's exact and χ 2 tests assessed differences among groups in the proportion of FV purchased in study supermarkets at each time point. Multinomial logistic regression assessed differences among groups in the change in proportionate FV purchasing over time. Post-intervention, 49% of participants purchased ≥50% of their FV in study supermarkets. Compared to all other groups, the price reduction group was approximately twice as likely (RRR: 1.8-2.2) to have increased proportionate purchasing of FV in study supermarkets from baseline to post-intervention (psupermarkets during the intervention period. Unless food purchasing data are available for all sources, differential changes in purchasing patterns can make it difficult to discern the true impacts of nutrition interventions. The SHELf trial is registered with Current Controlled Trials Registration ISRCTN39432901, Registered 30 June 2010, Retrospectively registered ( http://www.isrctn.com/ISRCTN39432901 ).

Positive outcomes influence the rate and time to publication, but not the impact factor of publications of clinical trial results.

Directory of Open Access Journals (Sweden)

Pilar Suñé

Full Text Available OBJECTIVES: Publication bias may affect the validity of evidence based medical decisions. The aim of this study is to assess whether research outcomes affect the dissemination of clinical trial findings, in terms of rate, time to publication, and impact factor of journal publications. METHODS AND FINDINGS: All drug-evaluating clinical trials submitted to and approved by a general hospital ethics committee between 1997 and 2004 were prospectively followed to analyze their fate and publication. Published articles were identified by searching Pubmed and other electronic databases. Clinical study final reports submitted to the ethics committee, final reports synopses available online and meeting abstracts were also considered as sources of study results. Study outcomes were classified as positive (when statistical significance favoring experimental drug was achieved, negative (when no statistical significance was achieved or it favored control drug and descriptive (for non-controlled studies. Time to publication was defined as time from study closure to publication. A survival analysis was performed using a Cox regression model to analyze time to publication. Journal impact factors of identified publications were recorded. Publication rate was 48·4% (380/785. Study results were identified for 68·9% of all completed clinical trials (541/785. Publication rate was 84·9% (180/212 for studies with results classified as positive and 68·9% (128/186 for studies with results classified as negative (p<0·001. Median time to publication was 2·09 years (IC95 1·61-2·56 for studies with results classified as positive and 3·21 years (IC95 2·69-3·70 for studies with results classified as negative (hazard ratio 1·99 (IC95 1·55-2·55. No differences were found in publication impact factor between positive (median 6·308, interquartile range: 3·141-28·409 and negative result studies (median 8·266, interquartile range: 4·135-17·157. CONCLUSIONS

The acceptability and impact of a randomised controlled trial of welfare rights advice accessed via primary health care: qualitative study

Directory of Open Access Journals (Sweden)

Howel Denise

2006-06-01

Full Text Available Abstract Background Qualitative research is increasingly used alongside randomised controlled trials (RCTs to study a range of factors including participants' experiences of a trial. The need for a sound evidence base within public health will increase the need for RCTs of non-clinical interventions. Welfare rights advice has been proposed as an intervention with potential to reduce health inequalities. This qualitative study, nested within an RCT of the impact of welfare rights advice, examined the acceptability of the intervention, the acceptability of the research process and the perceived impact of the intervention. Methods 25 men and women aged 60 years or over were recruited from four general practices in Newcastle upon Tyne (UK, a sub-sample of those who consented to be contacted (n = 96 during the RCT baseline interview. Semi-structured interviews were undertaken and analysed using the Framework Method. Results Participants viewed the trial positively although, despite agreeing that the information leaflet was clear, some had agreed to participate without being fully aware of what was involved. Some participants were unaware of the implications of randomisation. Most thought it fair, but a few concerns were raised about the control condition. The intervention was acceptable and made participants feel confident about applying for benefit entitlements. 14 out of 25 participants received some financial award; median weekly income gain was £57 (€84, $101. The perceived impact of additional finances was considerable and included: increased affordability of necessities and occasional expenses; increased capacity to deal with emergencies; and a reduction in stress related to financial worries. Overall, perceived independence and ability to participate in society increased. Most participants perceived benefits to their mental well-being, but no-one reported an improvement in physical health. The RCT showed little or no effect on a wide range

Pre-school reading badge called "Iridescent Little Fish" and its impact on reading habits later in life

Directory of Open Access Journals (Sweden)

Slavka Kristan

1997-01-01

Full Text Available The project called Footsteps to the Book is being carried out at the youth department of the Library Miran Jarc in Novo mesto; in it, preschool children from the municipalities Novo mesto, Šentjernej and Škocjan participate. The child wins the reading badge - Iridescent Little Fish with a pin - by telling four stories (or poemsin the library that havebeen told or read to him by his parents. Family appreciation can be won by both parents and children. The project has been started with the intention of lessening the impact of media upon children, and of strengthening the spiritual bondage among parents and children through reading. The purpose of the above mentioned activity is to develop and enrich child's language and thinking and help h im form positive self esteem. Through family reading, we tried to attract to the library not only small children but also their parents and to get them accustomed to the regular use of library materials. The opinions of parents,librarians, teachers and educators are very encouraging and the cooperation of children is better each year.

Modelling spatial trends in sorghum breeding field trials using a two-dimensional P-spline mixed model

NARCIS (Netherlands)

Velazco, Julio G.; Rodríguez-Álvarez, María Xosé; Boer, Martin P.; Jordan, David R.; Eilers, Paul H.C.; Malosetti, Marcos; Eeuwijk, van Fred A.

2017-01-01

Key message: A flexible and user-friendly spatial method called SpATS performed comparably to more elaborate and trial-specific spatial models in a series of sorghum breeding trials. Abstract: Adjustment for spatial trends in plant breeding field trials is essential for efficient evaluation and

Trial sponsorship and self-reported conflicts of interest in breast cancer radiation therapy: An analysis of prospective clinical trials.

Science.gov (United States)

Leite, Elton T T; Moraes, Fabio Y; Marta, Gustavo N; Taunk, Neil K; Vieira, Marina T L; Hanna, Samir A; Silva, João Luis F; Carvalho, Heloisa A

2017-06-01

We aim to assess any association between study and self-reported conflict of interest (COI) or trial sponsorship in breast cancer radiation clinical trials. We searched PubMed for all clinical trials (CTs) published between 09/2004 and 09/2014 related to breast cancer. We included only radiotherapy CTs with primary clinical endpoints. We classified eligible trials according to the funding source, presence or absence of conflict of interest, study conclusion and impact factor (IF). 1,603 CTs were retrieved. 72 randomized clinical trials were included for analysis. For-profit (PO), not for profit organization (nPO), none and not reported sponsorship rates were 9/72 (12.5%), 35/72 (48.6%), 1/72 (1.4%), 27/72 (37.5%), respectively. Present, absent or not reported COI were found in 6/72 (8.3%), 43/72 (59.7%) and 23/72 (32%) of the CTs, respectively. Conclusion was positive, neutral and negative in 57/72 (79.1%), 9/72 (12.5%) and 6/72 (8.4%) of the trials, respectively. Positive conclusion was reported in 33/44 (75%) funded trials (PO and nPO) and 5/6 (83.3%) CTs with reported COI. On univariate analysis no association with funding source (P=0.178), COI (P=0.678) or trial region (P=0.567) and trial positive conclusion was found. Sponsored trials (HR 4.50, 95CI-0.1.23-16.53;P=0.0023) and positive trials (HR 4.78, 95CI- 1.16-19.63;P=0.030) were more likely to be published in higher impact factor journals in the multivariate analysis. nPO funding was reported in almost 50% of the evaluated CTs. No significant association between study conclusion and funding source, COI or trial region was identified. Sponsored trials and positive trials were more likely to be published in higher impact factor journals. Copyright © 2017 Elsevier Ltd. All rights reserved.

Impact of human milk pasteurization on gastric digestion in preterm infants: a randomized controlled trial.

Science.gov (United States)

de Oliveira, Samira C; Bellanger, Amandine; Ménard, Olivia; Pladys, Patrick; Le Gouar, Yann; Dirson, Emelyne; Kroell, Florian; Dupont, Didier; Deglaire, Amélie; Bourlieu, Claire

2017-02-01

Holder pasteurization has been reported to modify human milk composition and structure by inactivating bile salt-stimulated lipase (BSSL) and partially denaturing some of its proteins, potentially affecting its subsequent digestion. We sought to determine the impact of human milk pasteurization on gastric digestion (particularly for proteins and lipids) in preterm infants who were fed their mothers' own milk either raw or pasteurized. In a randomized controlled trial, 12 hospitalized tube-fed preterm infants were their own control group in comparing the gastric digestion of raw human milk (RHM) with pasteurized human milk (PHM). Over a 6-d sequence, gastric aspirates were collected 2 times/d before and after RHM or PHM ingestion. The impact of milk pasteurization digestive kinetics and disintegration was tested with the use of a general linear mixed model. Despite inactivating BSSL, instantaneous lipolysis was not affected by pasteurization (mean ± SD at 90 min: 12.6% ± 4.7%; P > 0.05). Lipolysis occurred in milk before digestion and was higher for PHM than for RHM (mean ± SD: 3.2% ± 0.6% and 2.2% ± 0.8%, respectively; P Pasteurization enhanced the proteolysis of lactoferrin (P Pasteurization did not affect gastric emptying (∼30-min half time) or pH (mean ± SD: 4.4 ± 0.8) at 90 min. Overall, pasteurization had no impact on the gastric digestion of lipids and some proteins from human milk but did affect lactoferrin and α-lactalbumin proteolysis and emulsion disintegration. Freeze-thawing and pasteurization increased the milk lipolysis before digestion but did not affect gastric lipolysis. Possible consequences on intestinal digestion and associated nutritional outcomes were not considered in this study. This trial was registered at clinicaltrials.gov as NCT02112331. © 2017 American Society for Nutrition.

Why we need easy access to all data from all clinical trials and how to accomplish it

DEFF Research Database (Denmark)

Gotzsche, Peter C

2011-01-01

ABSTRACT: International calls for registering all trials involving humans and for sharing the results, and sometimes also the raw data and the trial protocols, have increased in recent years. Such calls have come, for example, from the Organization for Economic Cooperation and Development (OECD......), the World Health Organization (WHO), the US National Institutes of Heath, the US Congress, the European Commission, the European ombudsman, journal editors, The Cochrane Collaboration, and several funders, for example the UK Medical Research Council, the Wellcome Trust, the Bill and Melinda Gates Foundation...... why it is a moral imperative to render all results from all trials involving humans, also healthy volunteers, publicly available. Respect for trial participants who often run a personal and unknown risk by participating in trials requires that they - and therefore also the society at large...

Creating a vision for your medical call center.

Science.gov (United States)

Barr, J L; Laufenberg, S; Sieckman, B L

1998-01-01

MCC technologies and applications that can have a positive impact on managed care delivery are almost limitless. As you determine your vision, be sure to have in mind the following questions: (1) Do you simply want an efficient front end for receiving calls? (2) Do you want to offer triage services? (3) Is your organization ready for a fully functional "electronic physician's office?" Understand your organization's strategy. Where are you going, not only today but five years from now? That information is essential to determine your vision. Once established, your vision will help determine what you need and whether you should build or outsource. Vendors will assist in cost/benefit analysis of their equipment, but do not lose sight of internal factors such as "prior inclination" costs in the case of a nurse triage program. The technology is available to take your vision to its outer reaches. With the projected increase in utilization of call center services, don't let your organization be left behind!

NCI, FNLCR Help Launch Pediatric MATCH Precision Medicine Trial | Poster

Science.gov (United States)

The National Cancer Institute and Children’s Oncology Group recently opened enrollment for a new Phase II trial of personalized precision cancer therapies. Called the Pediatric Molecular Analysis for Therapy Choice (Pediatric MATCH), the trial seeks to treat children and adolescents aged 1­–21 whose solid tumors have failed to respond to or re-emerged after traditional cancer

The effect of genetic test-based risk information on behavioral outcomes: A critical examination of failed trials and a call to action.

Science.gov (United States)

Austin, Jehannine

2015-12-01

Encouraging individuals at risk for common complex disease like heart disease, cancer, and diabetes to adopt lifestyle changes (e.g., smoking cessation, exercise, proper nutrition, increased screening) could be powerful public health tools to decrease the enormous personal and economic burden of these conditions. Theoretically, genetic risk information appears to be a compelling tool that could be used to provoke at-risk individuals to adopt these lifestyle changes. Unfortunately, however, numerous studies now have shown that providing individuals with genetic test-based risk information has little to no impact on their behavior. In this article (a commentary not a systematic review), the failed trials in which genetic information has been used as a tool to induce behavior change will be critically examined in order to identify new and potentially more effective ways forward. © 2015 Wiley Periodicals, Inc.

Core journals that publish clinical trials of physical therapy interventions.

Science.gov (United States)

Costa, Leonardo Oliveira Pena; Moseley, Anne M; Sherrington, Catherine; Maher, Christopher G; Herbert, Robert D; Elkins, Mark R

2010-11-01

The objective of this study was to identify core journals in physical therapy by identifying those that publish the most randomized controlled trials of physical therapy interventions, provide the highest-quality reports of randomized controlled trials, and have the highest journal impact factors. This study was an audit of a bibliographic database. All trials indexed in the Physiotherapy Evidence Database (PEDro) were analyzed. Journals that had published at least 80 trials were selected. The journals were ranked in 4 ways: number of trials published; mean total PEDro score of the trials published in the journal, regardless of publication year; mean total PEDro score of the trials published in the journal from 2000 to 2009; and 2008 journal impact factor. The top 5 core journals in physical therapy, ranked by the total number of trials published, were Archives of Physical Medicine and Rehabilitation, Clinical Rehabilitation, Spine, British Medical Journal (BMJ), and Chest. When the mean total PEDro score was used as the ranking criterion, the top 5 journals were Journal of Physiotherapy, Journal of the American Medical Association (JAMA), Stroke, Spine, and Clinical Rehabilitation. When the mean total PEDro score of the trials published from 2000 to 2009 was used as the ranking criterion, the top 5 journals were Journal of Physiotherapy, JAMA, Lancet, BMJ, and Pain. The most highly ranked physical therapy-specific journals were Physical Therapy (ranked eighth on the basis of the number of trials published) and Journal of Physiotherapy (ranked first on the basis of the quality of trials). Finally, when the 2008 impact factor was used for ranking, the top 5 journals were JAMA, Lancet, BMJ, American Journal of Respiratory and Critical Care Medicine, and Thorax. There were no significant relationships among the rankings on the basis of trial quality, number of trials, or journal impact factor. Physical therapists who are trying to keep up-to-date by reading the best

The decision to conduct a head-to-head comparative trial: a game-theoretic analysis.

Science.gov (United States)

Mansley, Edward C; Elbasha, Elamin H; Teutsch, Steven M; Berger, Marc L

2007-01-01

Recent Medicare legislation calls on the Agency for Healthcare Research and Quality to conduct research related to the comparative effectiveness of health care items and services, including prescription drugs. This reinforces earlier calls for head-to-head comparative trials of clinically relevant treatment alternatives. Using a game-theoretic model, the authors explore the decision of pharmaceutical companies to conduct such trials. The model suggests that an important factor affecting this decision is the potential loss in market share and profits following a result of inferiority or comparability. This hidden cost is higher for the market leader than the market follower, making it less likely that the leader will choose to conduct a trial. The model also suggests that in a full-information environment, it will never be the case that both firms choose to conduct such a trial. Furthermore, if market shares and the probability of proving superiority are similar for both firms, it is quite possible that neither firm will choose to conduct a trial. Finally, the results indicate that incentives that offset the direct cost of a trial can prevent a no-trial equilibrium, even when both firms face the possibility of an inferior outcome.

Written pain neuroscience education in fibromyalgia: a multicenter randomized controlled trial.

Science.gov (United States)

van Ittersum, Miriam W; van Wilgen, C Paul; van der Schans, Cees P; Lambrecht, Luc; Groothoff, Johan W; Nijs, Jo

2014-11-01

Mounting evidence supports the use of face-to-face pain neuroscience education for the treatment of chronic pain patients. This study aimed at examining whether written education about pain neuroscience improves illness perceptions, catastrophizing, and health status in patients with fibromyalgia. A double-blind, multicenter randomized controlled clinical trial with 6-month follow-up was conducted. Patients with FM (n = 114) that consented to participate were randomly allocated to receive either written pain neuroscience education or written relaxation training. Written pain neuroscience education comprised of a booklet with pain neuroscience education plus a telephone call to clarify any difficulties; the relaxation group received a booklet with relaxation education and a telephone call. The revised illness perception questionnaire, Pain Catastrophizing Scale, and fibromyalgia impact questionnaire were used as outcome measures. Both patients and assessors were blinded. Repeated-measures analyses with last observation carried forward principle were performed. Cohen's d effect sizes (ES) were calculated for all within-group changes and between-group differences. The results reveal that written pain neuroscience education does not change the impact of FM on daily life, catastrophizing, or perceived symptoms of patients with FM. Compared with written relaxation training, written pain neuroscience education improved beliefs in a chronic timeline of FM (P = 0.03; ES = 0.50), but it does not impact upon other domains of illness perceptions. Compared with written relaxation training, written pain neuroscience education slightly improved illness perceptions of patients with FM, but it did not impart clinically meaningful effects on pain, catastrophizing, or the impact of FM on daily life. Face-to-face sessions of pain neuroscience education are required to change inappropriate cognitions and perceived health in patients with FM. © 2013 World Institute of Pain.

Impact of sodium citrate ingestion during recovery after dehydrating exercise on rehydration and subsequent 40-km cycling time-trial performance in the heat.

Science.gov (United States)

Suvi, Silva; Mooses, Martin; Timpmann, Saima; Medijainen, Luule; Narõškina, Daria; Unt, Eve; Ööpik, Vahur

2018-01-11

The purpose of this study was to assess the impact of sodium citrate (CIT) ingestion (600 mg·kg -1 ) during recovery from dehydrating cycling exercise (DE) on subsequent 40-km cycling performance in a warm environment (32 °C). Twenty male nonheat-acclimated endurance athletes exercised in the heat until 4% body mass (BM) loss occurred. After 16 h recovery with consumption of water ad libitum and prescribed diet (evening meal 20 kcal·kg -1 , breakfast 12 kcal·kg -1 ) supplemented in a double-blind, randomized, crossover manner with CIT or placebo (PLC), they performed 40-km time-trial (TT) on a cycle ergometer in a warm environment. During recovery greater increases in BM and plasma volume (PV) concomitant with greater water intake and retention occurred in the CIT trial compared with the PLC trial (p 0.05) in sweat loss, PV decrement, ratings of perceived exertion, or TT time (CIT 68.10 ± 3.28 min, PLC 68.11 ± 2.87 min). At the end of TT blood lactate concentration was higher (7.58 ± 2.44 mmol·L -1 vs 5.58 ± 1.32 mmol·L -1 ; p = 0.0002) and rectal temperature lower (39.54 ± 0.50 °C vs 39.65 ± 0.52 °C; p = 0.033) in the CIT trial than in the PLC trial. Compared with pre-DE time point, PV had decreased to a lower level in the PLC trial than in the CIT trial (p = 0.0001). In conclusion, CIT enhances rehydration after exercise-induced dehydration but has no impact on subsequent 40-km cycling TT performance in a warm uncompensable environment.

Impact of weed control strategies on resistance evolution in Alopecurus myosuroides – a long-term field trial

Directory of Open Access Journals (Sweden)

Ulber, Lena

2016-02-01

Full Text Available The impact of various herbicide strategies on populations of Alopecurus myosuroides is investigated in a longterm field trial situated in Wendhausen (Germany since 2009. In the initial years of the field experiment, resistant populations were selected by means of repeated application of the same herbicide active ingredients. For the selection of different resistance profiles, herbicides with actives from different HRAC groups were used. The herbicide actives flupyrsulfuron, isoproturon und fenoxaprop-P were applied for two years on large plots. In a succeeding field trial starting in 2011, it was investigated if the now existing resistant field populations could be controlled by various herbicide strategies. Eight different strategies consisting of various herbicide combinations were tested. Resistance evolution was investigated by means of plant counts and molecular genetic analysis.

Does the rising placebo response impact antihypertensive clinical trial outcomes? An analysis of data from the Food and Drug Administration 1990-2016.

Directory of Open Access Journals (Sweden)

Arif Khan

Full Text Available Recent studies show that placebo response has grown significantly over time in clinical trials for antidepressants, ADHD medications, antiepileptics, and antidiabetics. Contrary to expectations, trial outcome measures and success rates have not been impacted. This study aimed to see if this trend of increasing placebo response and stable efficacy outcome measures is unique to the conditions previously studied or if it occurs in trials for conditions with physiologically-measured symptoms, such as hypertension.For this reason, we evaluated the efficacy data reported in the US Food and Drug Administration Medical and Statistical reviews for 23 antihypertensive programs (32,022 patients, 63 trials, 142 treatment arms. Placebo and medication response, effect sizes, and drug-placebo differences were calculated for each treatment arm and examined over time using meta-regression. We also explored the relationship of sample size, trial duration, baseline blood pressure, and number of treatment arms to placebo/drug response and efficacy outcome measures.Like trials of other conditions, placebo response has risen significantly over time (R2 = 0.093, p = 0.018 and effect size (R2 = 0.013, p = 0.187 drug-placebo difference (R2 = 0.013, p = 0.182 and success rate (134/142, 94.4% have remained unaffected, likely due to a significant compensatory increase in antihypertensive response (R2 = 0.086, p<0.001. Treatment arms are likely overpowered with sample sizes increasing over time (R2 = 0.387, p<0.0001 and stable, large effect sizes (0.78 ±0.37. The exploratory analysis of sample size, trial duration, baseline blood pressure, and number of treatment arms yielded mixed results unlikely to explain the pattern of placebo response and efficacy outcomes over time. The magnitude of placebo response had no relationship to effect size (p = 0.877, antihypertensive-placebo differences (p = 0.752, or p-values (p = 0.963 but was correlated with antihypertensive response

Call Centre- Computer Telephone Integration

Directory of Open Access Journals (Sweden)

Dražen Kovačević

2012-10-01

Full Text Available Call centre largely came into being as a result of consumerneeds converging with enabling technology- and by the companiesrecognising the revenue opportunities generated by meetingthose needs thereby increasing customer satisfaction. Regardlessof the specific application or activity of a Call centre, customersatisfaction with the interaction is critical to the revenuegenerated or protected by the Call centre. Physical(v, Call centreset up is a place that includes computer, telephone and supervisorstation. Call centre can be available 24 hours a day - whenthe customer wants to make a purchase, needs information, orsimply wishes to register a complaint.

Orion: a web-based application designed to monitor resident and fellow performance on-call.

Science.gov (United States)

Itri, Jason N; Kim, Woojin; Scanlon, Mary H

2011-10-01

Radiology residency and fellowship training provides a unique opportunity to evaluate trainee performance and determine the impact of various educational interventions. We have developed a simple software application (Orion) using open-source tools to facilitate the identification and monitoring of resident and fellow discrepancies in on-call preliminary reports. Over a 6-month period, 19,200 on-call studies were interpreted by 20 radiology residents, and 13,953 on-call studies were interpreted by 25 board-certified radiology fellows representing eight subspecialties. Using standard review macros during faculty interpretation, each of these reports was classified as "agreement", "minor discrepancy", and "major discrepancy" based on the potential to impact patient management or outcome. Major discrepancy rates were used to establish benchmarks for resident and fellow performance by year of training, modality, and subspecialty, and to identify residents and fellows demonstrating a significantly higher major discrepancy rate compared with their classmates. Trends in discrepancies were used to identify subspecialty-specific areas of increased major discrepancy rates in an effort to tailor the didactic and case-based curriculum. A series of missed-case conferences were developed based on trends in discrepancies, and the impact of these conferences is currently being evaluated. Orion is a powerful information technology tool that can be used by residency program directors, fellowship programs directors, residents, and fellows to improve radiology education and training.

Using poison center exposure calls to predict methadone poisoning deaths.

Directory of Open Access Journals (Sweden)

Nabarun Dasgupta

Full Text Available PURPOSE: There are more drug overdose deaths in the Untied States than motor vehicle fatalities. Yet the US vital statistics reporting system is of limited value because the data are delayed by four years. Poison centers report data within an hour of the event, but previous studies suggested a small proportion of poisoning deaths are reported to poison centers (PC. In an era of improved electronic surveillance capabilities, exposure calls to PCs may be an alternate indicator of trends in overdose mortality. METHODS: We used PC call counts for methadone that were reported to the Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS® System in 2006 and 2007. US death certificate data were used to identify deaths due to methadone. Linear regression was used to quantify the relationship of deaths and poison center calls. RESULTS: Compared to decedents, poison center callers tended to be younger, more often female, at home and less likely to require medical attention. A strong association was found with PC calls and methadone mortality (b=0.88, se=0.42, t=9.5, df=1, p<0.0001, R(2 =0.77. These findings were robust to large changes in a sensitivity analysis assessing the impact of underreporting of methadone overdose deaths. CONCLUSIONS: Our results suggest that calls to poison centers for methadone are correlated with poisoning mortality as identified on death certificates. Calls received by poison centers may be used for timely surveillance of mortality due to methadone. In the midst of the prescription opioid overdose epidemic, electronic surveillance tools that report in real-time are powerful public health tools.

Accelerating stem cell trials for Alzheimer's disease.

Science.gov (United States)

Hunsberger, Joshua G; Rao, Mahendra; Kurtzberg, Joanne; Bulte, Jeff W M; Atala, Anthony; LaFerla, Frank M; Greely, Henry T; Sawa, Akira; Gandy, Sam; Schneider, Lon S; Doraiswamy, P Murali

2016-02-01

At present, no effective cure or prophylaxis exists for Alzheimer's disease. Symptomatic treatments are modestly effective and offer only temporary benefit. Advances in induced pluripotent stem cell (iPSC) technology have the potential to enable development of so-called disease-in-a-dish personalised models to study disease mechanisms and reveal new therapeutic approaches, and large panels of iPSCs enable rapid screening of potential drug candidates. Different cell types can also be produced for therapeutic use. In 2015, the US Food and Drug Administration granted investigational new drug approval for the first phase 2A clinical trial of ischaemia-tolerant mesenchymal stem cells to treat Alzheimer's disease in the USA. Similar trials are either underway or being planned in Europe and Asia. Although safety and ethical concerns remain, we call for the acceleration of human stem cell-based translational research into the causes and potential treatments of Alzheimer's disease. Copyright © 2016 Elsevier Ltd. All rights reserved.

[Impact of microdose clinical trials in the preclinical stage].

Science.gov (United States)

Kim, Soonih

2014-01-01

A microdose clinical trial may be useful as a safe early-phase exploratory study using doses as low as 100 μg or less for determination of the disposition of a candidate compound in humans in a short period of time. This may increase confidence in candidate compounds, especially those for which it is difficult to predict disposition based on the results of in vitro or preclinical studies. In this study, we examined microdose trials performed in the preclinical stage for two first-in-class compounds with a new mechanism of action. These compounds showed species difference in first pass metabolism in the digestive tract and liver, causing uncertainty in prediction of disposition in humans. For this reason, first-in-human microdose clinical trials were performed. The results showed that the two compounds had effective blood concentrations after oral administration at a dose of 100 mg qd. Administration of an extremely small dose of one (14)C-labeled compound permitted identification of major metabolites. No toxic metabolites were detected. The preclinical toxic dose was determined based on prediction of blood exposure at the estimated maximum clinical dose. For the other candidate compound, the findings of the microdose trial indicated a high bioavailability after oral administration and low hepatic clearance after intravenous administration. These results suggested only a small risk of a change in disposition in patients with hepatic disorder. The data obtained for the two compounds suggest that microdose clinical trials can be useful for improving the process of candidate selection in the preclinical stage.

Impact of family history assessment on communication with family members and health care providers: A report from the Family Healthware™ Impact Trial (FHITr).

Science.gov (United States)

Wang, Catharine; Sen, Ananda; Plegue, Melissa; Ruffin, Mack T; O'Neill, Suzanne M; Rubinstein, Wendy S; Acheson, Louise S

2015-08-01

This study examines the impact of Family Healthware™ on communication behaviors; specifically, communication with family members and health care providers about family health history. A total of 3786 participants were enrolled in the Family Healthware™ Impact Trial (FHITr) in the United States from 2005-7. The trial employed a two-arm cluster-randomized design, with primary care practices serving as the unit of randomization. Using generalized estimating equations (GEE), analyses focused on communication behaviors at 6month follow-up, adjusting for age, site and practice clustering. A significant interaction was observed between study arm and baseline communication status for the family communication outcomes (p'scommunicating at baseline and those who were not. Among participants who were not communicating at baseline, intervention participants had higher odds of communicating with family members about family history risk (OR=1.24, p=0.042) and actively collecting family history information at follow-up (OR=2.67, p=0.026). Family Healthware™ did not have a significant effect on family communication among those already communicating at baseline, or on provider communication, regardless of baseline communication status. Greater communication was observed among those at increased familial risk for a greater number of diseases. Family Healthware™ prompted more communication about family history with family members, among those who were not previously communicating. Efforts are needed to identify approaches to encourage greater sharing of family history information, particularly with health care providers. Copyright © 2015 Elsevier Inc. All rights reserved.

From the Cotton Fields to the Ties That Bind: Jim Pusack's Enduring Impact on Today's CALL Development

Science.gov (United States)

Jones, Linda C.

2010-01-01

From 1981 to today, the encouragement Jim Pusack and his colleague Sue Otto gave faculty to develop and/or implement CALL into the curriculum has been vital to our L2 teaching evolution. This article describes how their efforts evolved over the last two and a half decades and the ties that bind their efforts with today's CALL development.

Impact assessment of the European Clinical Trials Directive: a longitudinal, prospective, observational study analyzing patterns and trends in clinical drug trial applications submitted since 2001 to regulatory agencies in six EU countries

Directory of Open Access Journals (Sweden)

Hartmann Markus

2012-04-01

Full Text Available Abstract Background Shifts in clinical trial application rates over time indicate if the attractiveness of a country or region for the conduct of clinical trials is growing or decreasing. The purpose of this observational study was to track changes in drug trial application patterns across several EU countries in order to analyze the medium-term impact of the EU Clinical Trials Directive 2001/20/EC on the conduct of drug trials. Methods Rates of Clinical Trial Applications (CTA for studies with medicinal products in those six countries in the EU, which authorize on average more than 500 trials per year, were analyzed. Publicly available figures on the number of annually submitted CTA, the distribution of trials per phase and the type of sponsorship were tracked; missing data were provided by national drug agencies. Results Since 2001, the number of CTA in Italy and Spain increased significantly (5.0 and 2.5% average annual growth. For Italy, the gain was driven by a strong increase of applications from academic trial sponsors; Spain's growth was due to a rise in trials run by commercial sponsors. The Netherlands, Germany, France and the UK saw a decline (1.9, 2.3, 3.0 and 5.3% average annual diminution; significant (P Conclusions The EU Clinical Trials Directive 2001/20/EC did not achieve the harmonization of clinical trial requirements across Europe. Rather, it resulted in the leveling of clinical trial activities caused by a continuing decrease in CTA rates in the Netherlands, Germany, France and the UK. Southern European countries, Italy and Spain, benefited to some extent from policy changes introduced by the Directive. In Italy's case, national funding measures helped to considerably promote the conduct of non-commercial trials. On the other hand, the EU Directive-driven transition from liberal policy environments, based on non-explicit trial approval through notifications, towards red-taped processes of trial authorization, contributed to

Narrating the Mensalão trial

DEFF Research Database (Denmark)

Damgaard, Mads

2015-01-01

Coming to a close in the last days of 2012, the trial of the so-called mensalão network was heralded as Brazil's trial of the century. Involving corruption in the top ranks of the business world and the former government, the process ended with an exceptional result in the sense that severe...... sentences were meted out to 25 of the 38 defendants, thereby breaking an established pattern of impunity for corrupt politicians in Brazilian courts. As a scandal potentially harmful for the governing party and the former president Luis “Lula” da Silva, the eyes and spotlights of the national media were...... fixed on the trial. However, the varying and contested ways in which the case was presented by media from the outbreak of the scandal in 2005 until the end of the trial bears witness to the fact that narratives concerning corruption scandals can potentially encompass a broad range of political...

Surgeon distress as calibrated by hours worked and nights on call.

Science.gov (United States)

Balch, Charles M; Shanafelt, Tait D; Dyrbye, Lotte; Sloan, Jeffrey A; Russell, Thomas R; Bechamps, Gerald J; Freischlag, Julie A

2010-11-01

The relationships of working hours and nights on call per week with various parameters of distress among practicing surgeons have not been previously examined in detail. More than 7,900 members of the American College of Surgeons responded to an anonymous, cross-sectional survey. The survey included self-assessment of their practice setting, a validated depression screening tool, and standardized assessments of burnout and quality of life. There was a clear gradient between hours and burnout, with the prevalence of burnout ranging from 30% for surgeons working hours/week, 44% for 60 to 80 hours/week, and 50% for those working >80 hours/week (p hours and nights on call (both p worked >80 hours/week reported a higher rate of medical errors compared with those who worked hours/week (10.7% versus 6.9%; p work and home conflicts were higher among surgeons who worked longer hours or had ≥2 nights on call. A significantly higher proportion of surgeons who worked >80 hours/week or had >2 nights on call/week would not become a surgeon again (p hours worked and nights on call per week appear to have a substantial impact on surgeons, both professionally and personally. These factors are strongly related to burnout, depression, career satisfaction, and work and home conflicts. Copyright © 2010 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Randomised controlled trials and changing public health practice

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Anne Cockcroft

2017-05-01

Full Text Available Abstract One reason for doing randomised controlled trials (RCTs is that experiments can be convincing. Early epidemiological experimenters, such as Jenner and the smallpox vaccine and Snow and his famous Broad Street pump handle, already knew the answer they were demonstrating; they used the experiments as knowledge translation devices to convince others. More sophisticated modern experiments include cluster randomised controlled trials (CRCTs for experiments in the public health setting. The knowledge translation value remains: RCTs and CRCTs can potentially stimulate changes of practice among stakeholders. Capitalising on the knowledge translation value of RCTs requires more than the standard reporting of trials. Those who are convinced by a trial and want to act, need to know how the trial relates to their own context, what contributed to success, and what might make it even more effective. Implementation research unpacks the back-story, examining how and why an intervention worked. The Camino Verde trial of community mobilisation for control of dengue reported a significant impact on entomological indices of the Aedes aegypti vector, and on serological dengue virus infection and self-reported dengue cases. This important study should lead to studies of similar interventions in other contexts, and ultimately to changes in dengue control practices. This supplement is the back-story of the trial, providing information to help researchers and planners to make use of the trial findings. Background articles include the full protocol, a systematic review of CRCTs of approaches for Aedes aegypti control, epidemiological and entomological findings from the baseline survey, and how baseline findings were used to set up the intervention. Secondary analyses of the entomological findings examine associations with the use of the larvicide temephos, and the impact of the intervention in different conditions of water supply and seasons. Other articles

Does the rising placebo response impact antihypertensive clinical trial outcomes? An analysis of data from the Food and Drug Administration 1990-2016

Science.gov (United States)

Fahl Mar, Kaysee; Schilling, Joshua; Brown, Walter A.

2018-01-01

Background Recent studies show that placebo response has grown significantly over time in clinical trials for antidepressants, ADHD medications, antiepileptics, and antidiabetics. Contrary to expectations, trial outcome measures and success rates have not been impacted. This study aimed to see if this trend of increasing placebo response and stable efficacy outcome measures is unique to the conditions previously studied or if it occurs in trials for conditions with physiologically-measured symptoms, such as hypertension. Method For this reason, we evaluated the efficacy data reported in the US Food and Drug Administration Medical and Statistical reviews for 23 antihypertensive programs (32,022 patients, 63 trials, 142 treatment arms). Placebo and medication response, effect sizes, and drug-placebo differences were calculated for each treatment arm and examined over time using meta-regression. We also explored the relationship of sample size, trial duration, baseline blood pressure, and number of treatment arms to placebo/drug response and efficacy outcome measures. Results Like trials of other conditions, placebo response has risen significantly over time (R2 = 0.093, p = 0.018) and effect size (R2 = 0.013, p = 0.187) drug-placebo difference (R2 = 0.013, p = 0.182) and success rate (134/142, 94.4%) have remained unaffected, likely due to a significant compensatory increase in antihypertensive response (R2 = 0.086, parms are likely overpowered with sample sizes increasing over time (R2 = 0.387, pblood pressure, and number of treatment arms yielded mixed results unlikely to explain the pattern of placebo response and efficacy outcomes over time. The magnitude of placebo response had no relationship to effect size (p = 0.877), antihypertensive-placebo differences (p = 0.752), or p-values (p = 0.963) but was correlated with antihypertensive response (R2 = 0.347, p<0.0001). Conclusions As hypothesized, this study shows that placebo response is increasing in clinical

Does different information disclosure on placebo control affect blinding and trial outcomes? A case study of participant information leaflets of randomized placebo-controlled trials of acupuncture

Directory of Open Access Journals (Sweden)

Soyeon Cheon

2018-01-01

Full Text Available Abstract Background While full disclosure of information on placebo control in participant information leaflets (PILs in a clinical trial is ethically required during informed consent, there have been concerning voices such complete disclosures may increase unnecessary nocebo responses, breach double-blind designs, and/or affect direction of trial outcomes. Taking an example of acupuncture studies, we aimed to examine what participants are told about placebo controls in randomized, placebo-controlled trials, and how it may affect blinding and trial outcomes. Methods Authors of published randomized, placebo-controlled trials of acupuncture were identified from PubMed search and invited to provide PILs for their trials. The collected PILs were subjected to content analysis and categorized based on degree of information disclosure on placebo. Blinding index (BI as a chance-corrected measurement of blinding was calculated and its association with different information disclosure was examined. The impact of different information disclosure from PILs on primary outcomes was estimated using a random effects model. Results In 65 collected PILs, approximately 57% of trials fully informed the participants of placebo control, i.e. full disclosure, while the rest gave deceitful or no information on placebo, i.e. no disclosure. Placebo groups in the studies with no disclosure tended to make more opposite guesses on the type of received intervention than those with disclosure, which may reflect wishful thinking (BI −0.21 vs. −0.16; p = 0.38. In outcome analysis, studies with no disclosure significantly favored acupuncture than those with full disclosure (standardized mean difference − 0.43 vs. −0.12; p = 0.03, probably due to enhanced expectations. Conclusions How participants are told about placebos can be another potential factor that may influence participant blinding and study outcomes by possibly modulating patient expectation. As we

Call cultures in orang-utans?

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Serge A Wich

Full Text Available BACKGROUND: Several studies suggested great ape cultures, arguing that human cumulative culture presumably evolved from such a foundation. These focused on conspicuous behaviours, and showed rich geographic variation, which could not be attributed to known ecological or genetic differences. Although geographic variation within call types (accents has previously been reported for orang-utans and other primate species, we examine geographic variation in the presence/absence of discrete call types (dialects. Because orang-utans have been shown to have geographic variation that is not completely explicable by genetic or ecological factors we hypothesized that this will be similar in the call domain and predict that discrete call type variation between populations will be found. METHODOLOGY/PRINCIPAL FINDINGS: We examined long-term behavioural data from five orang-utan populations and collected fecal samples for genetic analyses. We show that there is geographic variation in the presence of discrete types of calls. In exactly the same behavioural context (nest building and infant retrieval, individuals in different wild populations customarily emit either qualitatively different calls or calls in some but not in others. By comparing patterns in call-type and genetic similarity, we suggest that the observed variation is not likely to be explained by genetic or ecological differences. CONCLUSION/SIGNIFICANCE: These results are consistent with the potential presence of 'call cultures' and suggest that wild orang-utans possess the ability to invent arbitrary calls, which spread through social learning. These findings differ substantially from those that have been reported for primates before. First, the results reported here are on dialect and not on accent. Second, this study presents cases of production learning whereas most primate studies on vocal learning were cases of contextual learning. We conclude with speculating on how these findings might

Impact of homogenization of pasteurized human milk on gastric digestion in the preterm infant: A randomized controlled trial.

Science.gov (United States)

de Oliveira, Samira C; Bellanger, Amandine; Ménard, Olivia; Pladys, Patrick; Le Gouar, Yann; Henry, Gwénaële; Dirson, Emelyne; Rousseau, Florence; Carrière, Frédéric; Dupont, Didier; Bourlieu, Claire; Deglaire, Amélie

2017-08-01

It has been suggested that homogenization of Holder-pasteurized human milk (PHM) could improve fat absorption and weight gain in preterm infants, but the impact on the PHM digestive kinetics has never been studied. Our objective was to determine the impact of PHM homogenization on gastric digestion in preterm infants. In a randomized controlled trial, eight hospitalized tube-fed preterm infants were their own control to compare the gastric digestion of PHM and of homogenized PHM (PHHM). PHM was obtained from donors and, for half of it, was homogenized by ultrasonication. Over a six-day sequence, gastric aspirates were collected twice a day, before and 35, 60 or 90 min after the start of PHM or PHHM ingestion. The impact of homogenization on PHM digestive kinetics and disintegration was tested using a general linear mixed model. Results were expressed as means ± SD. Homogenization leaded to a six-fold increase in the specific surface (P Homogenization increased the gastric lipolysis level (P Homogenization enhanced the proteolysis of serum albumin (P Homogenization of PHM increased the gastric lipolysis level. This could be a potential strategy to improve fat absorption, and thus growth and development in infants fed with PHM; however, its gastrointestinal tolerance needs to be investigated further. This trial was registered at clinicaltrials.gov as NCT02112331. Copyright © 2017 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.

A cluster randomized control trial to assess the impact of active learning on child activity, attention control, and academic outcomes: The Texas I-CAN trial.

Science.gov (United States)

Bartholomew, John B; Jowers, Esbelle M; Errisuriz, Vanessa L; Vaughn, Sharon; Roberts, Gregory

2017-10-01

Active learning is designed to pair physical activity with the teaching of academic content. This has been shown to be a successful strategy to increase physical activity and improve academic performance. The existing designs have confounded academic lessons with physical activity. As a result, it is impossible to determine if the subsequent improvement in academic performance is due to: (1) physical activity, (2) the academic content of the active learning, or (3) the combination of academic material taught through physical activity. The Texas I-CAN project is a 3-arm, cluster randomized control trial in which 28 elementary schools were assigned to either control, math intervention, or spelling intervention. As a result, each intervention condition serves as an unrelated content control for the other arm of the trial, allowing the impact of physical activity to be separated from the content. That is, schools that perform only active math lessons provide a content control for the spelling schools on spelling outcomes. This also calculated direct observations of attention and behavior control following periods of active learning. This design is unique in its ability to separate the impact of physical activity, in general, from the combination of physical activity and specific academic content. This, in combination with the ability to examine both proximal and distal outcomes along with measures of time on task will do much to guide the design of future, school-based interventions. Copyright © 2017 Elsevier Inc. All rights reserved.

Harm, benefit and costs associated with low-dose glucocorticoids added to the treatment strategies for rheumatoid arthritis in elderly patients (GLORIA trial): study protocol for a randomised controlled trial.

Science.gov (United States)

Hartman, Linda; Rasch, Linda A; Klausch, Thomas; Bijlsma, Hans W J; Christensen, Robin; Smulders, Yvo M; Ralston, Stuart H; Buttgereit, Frank; Cutolo, Maurizio; Da Silva, Jose A P; Opris, Daniela; Rovenský, Jozef; Szamosi, Szilvia; Middelink, Leonie M; Lems, Willem F; Boers, Maarten

2018-01-25

Rheumatoid arthritis (RA) is a chronic inflammatory disease of the joints affecting 1% of the world population. It has major impact on patients through disability and associated comorbidities. Current treatment strategies have considerably improved the prognosis, but recent innovations (especially biologic drugs and the new class of so-called "JAK/STAT inhibitors") have important safety issues and are very costly. Glucocorticoids (GCs) are highly effective in RA, and could reduce the need for expensive treatment with biologic agents. However, despite more than 65 years of clinical experience, there is a lack of studies large enough to adequately document the benefit/harm balance. The result is inappropriate treatment strategies, i.e. both under-use and over-use of GCs, and consequently suboptimal treatment of RA. The GLORIA study is a pragmatic multicentre, 2-year, randomised, double-blind, clinical trial to assess the safety and effectiveness of a daily dose of 5 mg prednisolone or matching placebo added to standard of care in elderly patients with RA. Eligible participants are diagnosed with RA, have inadequate disease control (disease activity score, DAS28 ≥ 2.6), and are ≥ 65 years. The primary outcome measures are the time-averaged mean value of the DAS28 and the occurrence of serious adverse events or adverse events of special interest. During the trial, change in antirheumatic therapy is permitted as clinically indicated, except for GCs. Cost-effectiveness and cost-utility are secondary outcomes. The main challenge is the interpretation of the trial result with two primary endpoints and the pragmatic trial design that allows co-interventions. Another challenge is the definition of safety and the relative lack of power to detect differences between treatment groups. We have chosen to define safety as the number of patients experiencing at least one serious adverse event. We also specify a decision tree to guide our conclusion on the balance of

Impact of Baseline Physical Activity and Diet Behavior on Metabolic Syndrome in a Pharmaceutical Trial: Results from NAVIGATOR

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Huffman, Kim M.; Sun, Jie-Lena; Thomas, Laine; Bales, Connie W.; Califf, Robert M.; Yates, Thomas; Davies, Melanie J.; Holman, Rury R.; McMurray, John J.V.; Bethel, M. Angelyn; Tuomilehto, Jaakko; Haffner, Steven M.; Kraus, William E.

2014-01-01

Objective The cardiometabolic risk cluster metabolic syndrome (MS) includes ≥3of elevated fasting glucose, hypertension, elevated triglycerides, reduced high-density lipoprotein cholesterol(HDL-c), and increased waist circumference. Each can be affected by physical activity and diet. Our objective was to determine whether determine whether baseline physical activity and/or diet behavior impact MS in the course of a large pharmaceutical trial. Materials/Methods This was an observational study from NAVIGATOR, a double-blind, randomized (nateglinide, valsartan, both, or placebo), controlled trial between 2002 and 2004. We studied data from persons (n=9306) with impaired glucose tolerance and cardiovascular disease (CVD) or CVD risk factors; 7118 with pedometer data were included in this analysis. Physical activity was assessed with 7-day pedometer records; diet behavior was self-reported on a 6-item survey. An MS score (MSSc) was calculated using the sum of each MS component, centered around the Adult Treatment Panel III threshold, and standardized according to sample standard deviation. Excepting HDL-c, assessed at baseline and year 3, MS components were assessed yearly. Follow-up averaged 6 years. Results For every 2000-stepincrease in average daily steps, there was an associated reduction in average MSSc of 0.29(95%CI−0.33to−0.25).For each diet behavior endorsed, there was an associated reduction in average MSSc of 0.05 (95%CI−0.08 to −0.01).Accounting for the effects of pedometer steps and diet behavior together had minimal impact on parameter estimates with no significant interaction. Relations were independent of age, sex, race, region, smoking, family history of diabetes, and use of nateglinide, valsartan, aspirin, antihypertensive, and lipid-lowering agent. Conclusions Baseline physical activity and diet behavior were associated independently with reductions in MSSc such that increased attention to these lifestyle elements providescardiometabolic

Examining the impact of genetic testing for type 2 diabetes on health behaviors: study protocol for a randomized controlled trial

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Voils Corrine I

2012-08-01

Full Text Available Abstract Background We describe the study design, procedures, and development of the risk counseling protocol used in a randomized controlled trial to evaluate the impact of genetic testing for diabetes mellitus (DM on psychological, health behavior, and clinical outcomes. Methods/Design Eligible patients are aged 21 to 65 years with body mass index (BMI ≥27 kg/m2 and no prior diagnosis of DM. At baseline, conventional DM risk factors are assessed, and blood is drawn for possible genetic testing. Participants are randomized to receive conventional risk counseling for DM with eye disease counseling or with genetic test results. The counseling protocol was pilot tested to identify an acceptable graphical format for conveying risk estimates and match the length of the eye disease to genetic counseling. Risk estimates are presented with a vertical bar graph denoting risk level with colors and descriptors. After receiving either genetic counseling regarding risk for DM or control counseling on eye disease, brief lifestyle counseling for prevention of DM is provided to all participants. Discussion A standardized risk counseling protocol is being used in a randomized trial of 600 participants. Results of this trial will inform policy about whether risk counseling should include genetic counseling. Trial registration ClinicalTrials.gov Identifier NCT01060540

The difficult medical emergency call

DEFF Research Database (Denmark)

Møller, Thea Palsgaard; Kjærulff, Thora Majlund; Viereck, Søren

2017-01-01

BACKGROUND: Pre-hospital emergency care requires proper categorization of emergency calls and assessment of emergency priority levels by the medical dispatchers. We investigated predictors for emergency call categorization as "unclear problem" in contrast to "symptom-specific" categories and the ......BACKGROUND: Pre-hospital emergency care requires proper categorization of emergency calls and assessment of emergency priority levels by the medical dispatchers. We investigated predictors for emergency call categorization as "unclear problem" in contrast to "symptom-specific" categories...... and the effect of categorization on mortality. METHODS: Register-based study in a 2-year period based on emergency call data from the emergency medical dispatch center in Copenhagen combined with nationwide register data. Logistic regression analysis (N = 78,040 individuals) was used for identification...

BUSINESS MODELS FOR EXTENDING OF 112 EMERGENCY CALL CENTER CAPABILITIES WITH E-CALL FUNCTION INSERTION

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Pop Dragos Paul

2010-12-01

Full Text Available The present article concerns present status of implementation in Romania and Europe of eCall service and the proposed business models regarding eCall function implementation in Romania. eCall system is used for reliable transmission in case of crush between In Vehicle System and Public Service Answering Point, via the voice channel of cellular and Public Switched Telephone Network (PSTN. eCall service could be initiated automatically or manual the driver. All data presented in this article are part of researches made by authors in the Sectorial Contract Implementation study regarding eCall system, having as partners ITS Romania and Electronic Solution, with the Romanian Ministry of Communication and Information Technology as beneficiary.

Recall and decay of consent information among parents of infants participating in a randomized controlled clinical trial using an audio-visual tool in The Gambia.

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Mboizi, Robert B; Afolabi, Muhammed O; Okoye, Michael; Kampmann, Beate; Roca, Anna; Idoko, Olubukola T

2017-09-02

Communicating essential research information to low literacy research participants in Africa is highly challenging, since this population is vulnerable to poor comprehension of consent information. Several supportive materials have been developed to aid participant comprehension in these settings. Within the framework of a pneumococcal vaccine trial in The Gambia, we evaluated the recall and decay of consent information during the trial which used an audio-visual tool called 'Speaking Book', to foster comprehension among parents of participating infants. The Speaking Book was developed in the 2 most widely spoken local languages. Four-hundred and 9 parents of trial infants gave consent to participate in this nested study and were included in the baseline assessment of their knowledge about trial participation. An additional assessment was conducted approximately 90 d later, following completion of the clinical trial protocol. All parents received a Speaking Book at the start of the trial. Trial knowledge was already high at the baseline assessment with no differences related to socio-economic status or education. Knowledge of key trial information was retained at the completion of the study follow-up. The Speaking Book (SB) was well received by the study participants. We hypothesize that the SB may have contributed to the retention of information over the trial follow-up. Further studies evaluating the impact of this innovative tool are thus warranted.

Assessing call centers’ success:

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Hesham A. Baraka

2013-07-01

This paper introduces a model to evaluate the performance of call centers based on the Delone and McLean Information Systems success model. A number of indicators are identified to track the call center’s performance. Mapping of the proposed indicators to the six dimensions of the D&M model is presented. A Weighted Call Center Performance Index is proposed to assess the call center performance; the index is used to analyze the effect of the identified indicators. Policy-Weighted approach was used to assume the weights with an analysis of different weights for each dimension. The analysis of the different weights cases gave priority to the User satisfaction and net Benefits dimension as the two outcomes from the system. For the input dimensions, higher priority was given to the system quality and the service quality dimension. Call centers decision makers can use the tool to tune the different weights in order to reach the objectives set by the organization. Multiple linear regression analysis was used in order to provide a linear formula for the User Satisfaction dimension and the Net Benefits dimension in order to be able to forecast the values for these two dimensions as function of the other dimensions

78 FR 76218 - Rural Call Completion

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2013-12-17

... calls to rural areas, and enforce restrictions against blocking, choking, reducing, or restricting calls... to alert the Commission of systemic problems receiving calls from a particular originating long... associated with completing calls to rural areas. These rules will also enhance our ability to enforce...

Long-distance calls in Neotropical primates

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Oliveira Dilmar A.G.

2004-01-01

Full Text Available Long-distance calls are widespread among primates. Several studies concentrate on such calls in just one or in few species, while few studies have treated more general trends within the order. The common features that usually characterize these vocalizations are related to long-distance propagation of sounds. The proposed functions of primate long-distance calls can be divided into extragroup and intragroup ones. Extragroup functions relate to mate defense, mate attraction or resource defense, while intragroup functions involve group coordination or alarm. Among Neotropical primates, several species perform long-distance calls that seem more related to intragroup coordination, markedly in atelines. Callitrichids present long-distance calls that are employed both in intragroup coordination and intergroup contests or spacing. Examples of extragroup directed long-distance calls are the duets of titi monkeys and the roars and barks of howler monkeys. Considerable complexity and gradation exist in the long-distance call repertoires of some Neotropical primates, and female long-distance calls are probably more important in non-duetting species than usually thought. Future research must focus on larger trends in the evolution of primate long-distance calls, including the phylogeny of calling repertoires and the relationships between form and function in these signals.

Study of the trial subjects’ protection aspects in Phase I clinical trials and bioequivalence studies

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K. O. Zupanets

2016-03-01

Full Text Available Protection of rights, health and well-being of persons who are taking the drug during the trial (trial subjects is one of the basic principles of clinical trials (CT management. Aim. In order to study key aspects of volunteer protection, determine factors that influence these indicators and estimate the importance of ensuring their proper implementation on the clinical site (CS three survey of 135 trial subjects were carried out to evaluate the importance of assessing the impact of factors such as the procedure of signing the informed consent (IC at the CS and testing procedures for HIV / AIDS, hepatitis and others. Assessment of the quality of life of trial subjects as indirect indicator of the quality of clinical trials that ensures the proper protection of their life was the subject of the third survey. Methods and results. The general model of the relationship between the key aspects of the trial subjects protection and the factors which are providing them during the clinical trials of drugs management was substantiated, which included the main aspects of the trial subjects’ protection, protective factors and basic CT management procedures, the impact of the above factors on the possibility of providing protection aspects depends on their implementation quality. It was found that trial subjects’ protection improvement can be achieved during the IC signing process. It is necessary to ensure a higher level of volunteers understanding of the terms that could be used in the IC form. Regarding the procedure of compulsory testing for HIV/AIDS in the course of screening, we can conclude that the majority of the trial subjects believe that this procedure is an additional factor in their health protection and do not consider it as an excessive psychological pressure on them. Conclusion. Assessing the quality of life during the bioequivalence study at the CS makes possible to reach a conclusion on general well-being and satisfaction with those

Impact of primary care provider knowledge, attitudes, and beliefs about cancer clinical trials: implications for referral, education and advocacy.

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Michaels, Margo; D'Agostino, Thomas A; Blakeney, Natasha; Weiss, Elisa S; Binz-Scharf, Maria C; Golant, Mitch; Bylund, Carma L

2015-03-01

Primary Care Providers (PCPs) can be instrumental in helping to prepare patients for referral to cancer treatment. It has been suggested that PCPs can have an important impact on priming patients about the possibility of receiving care within a cancer treatment clinical trial (CCT). However, little is understood about how to effectively engage primary care providers in educating patients about trials. Data were collected as part of two qualitative research projects about primary care providers' role in referral to treatment and to CCTs. Participants were 27 PCPs who agreed to take part in qualitative face-to-face or telephone interviews and serve predominantly underserved, minority populations. Interviews identified a number of factors influencing referral to oncologists, including patients' insurance coverage, location and proximity to treatment facilities, and the strength of ongoing relationships with and/or previous experience with a specialist. PCPs overwhelmingly expressed disinterest in discussing any treatment options, including CCTs. Misconceptions about quality of care received through trials were also common, presenting a deterrent to discussion. PCPs need targeted, evidence-based educational interventions to appropriately address their concerns about cancer clinical trials, enhance provider communication skills, and alter patient referral behavior. Steps must also be taken to strengthen communication between oncologists and referring PCPs.

[Ethical principles of clinical trials in minors].

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Koch, H J; Raschka, C

2002-12-05

Clinical trials in volunteers and patients are essential to ensure rational treatment of patients. As a rule, drugs are routinely developed for adults, but children are excluded. A major reason for this restriction are ethical justifications, in particular the lack of autonomy on the part of children. The principle of fairness, however, requires that everyone should benefit from progress. Industry, science and society are therefore called upon to find ways of making available safe and adequate treatment for children as quickly as possible, by defining the required conditions for pediatric clinical trials. Important principles are minimal risk, minimal invasivity, rapid decision-making, and careful documentation of trial results. Dynamic ethical principles, such as autonomy and competence in adolescents must be considered on equal footing with existing international GCP guidelines. Aspects of child psychology indicate that the autonomy of adolescents should be respected. Where economic incentives for such trials are absent, for example, in the case of non-pharmacological problems, pediatric trials must be considered a task for society as a whole.

Quantifying the Impact of Natural Immunity on Rotavirus Vaccine Efficacy Estimates: A Clinical Trial in Dhaka, Bangladesh (PROVIDE) and a Simulation Study.

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Rogawski, Elizabeth T; Platts-Mills, James A; Colgate, E Ross; Haque, Rashidul; Zaman, K; Petri, William A; Kirkpatrick, Beth D

2018-03-05

The low efficacy of rotavirus vaccines in clinical trials performed in low-resource settings may be partially explained by acquired immunity from natural exposure, especially in settings with high disease incidence. In a clinical trial of monovalent rotavirus vaccine in Bangladesh, we compared the original per-protocol efficacy estimate to efficacy derived from a recurrent events survival model in which children were considered naturally exposed and potentially immune after their first rotavirus diarrhea (RVD) episode. We then simulated trial cohorts to estimate the expected impact of prior exposure on efficacy estimates for varying rotavirus incidence rates and vaccine efficacies. Accounting for natural immunity increased the per-protocol vaccine efficacy estimate against severe RVD from 63.1% (95% confidence interval [CI], 33.0%-79.7%) to 70.2% (95% CI, 44.5%-84.0%) in the postvaccination period, and original year 2 efficacy was underestimated by 14%. The simulations demonstrated that this expected impact increases linearly with RVD incidence, will be greatest for vaccine efficacies near 50%, and can reach 20% in settings with high incidence and low efficacy. High rotavirus incidence leads to predictably lower vaccine efficacy estimates due to the acquisition of natural immunity in unvaccinated children, and this phenomenon should be considered when comparing efficacy estimates across settings. NCT01375647.

Determining the impact of a new physiotherapist-led primary care model for back pain: protocol for a pilot cluster randomized controlled trial.

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Miller, Jordan; Barber, David; Donnelly, Catherine; French, Simon; Green, Michael; Hill, Jonathan; MacDermid, Joy; Marsh, Jacquelyn; Norman, Kathleen; Richardson, Julie; Taljaard, Monica; Wideman, Timothy; Cooper, Lynn; McPhee, Colleen

2017-11-09

Back pain is a leading contributor to disability, healthcare costs, and lost work. Family physicians are the most common first point of contact in the healthcare system for people with back pain, but physiotherapists (PTs) may be able to support the primary care team through evidence-based primary care. A cluster randomized trial is needed to determine the clinical, health system, and societal impact of a primary care model that integrates physiotherapists at the first visit for people with back pain. Prior to conducting a future fully powered cluster randomized trial, we need to demonstrate feasibility of the methods. Therefore, the purpose of this pilot study will be to: 1) Determine feasibility of patient recruitment, assessment procedures, and retention. 2) Determine the feasibility of training and implementation of a new PT-led primary care model for low back pain (LBP) 3) Explore the perspectives of patients and healthcare providers (HCPs) related to their experiences and attitudes towards the new service delivery model, barriers/facilitators to implementation, perceived satisfaction, perceived value, and impact on clinic processes and patient outcomes. This pilot cluster randomized controlled trial will enroll four sites and randomize them to implement a new PT-led primary care model for back pain or a usual physician-led primary care model. All adults booking a primary care visit for back pain will be invited to participate. Feasibility outcomes will include: recruitment and retention rates, completeness of assessment data, PT training participation and confidence after training, and PT treatment fidelity. Secondary outcomes will include the clinical, health system, cost, and process outcomes planned for the future fully powered cluster trial. Results will be analyzed and reported descriptively and qualitatively. To explore perspectives of both HCPs and patients, we will conduct semi-structured qualitative interviews with patients and focus groups with HCPs

Can a documentary increase help-seeking intentions in men? A randomised controlled trial.

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King, Kylie Elizabeth; Schlichthorst, Marisa; Spittal, Matthew J; Phelps, Andrea; Pirkis, Jane

2018-01-01

We investigated whether a public health intervention-a three-part documentary called Man Up which explored the relationship between masculinity and mental health, well-being and suicidality-could increase men's intentions to seek help for personal and emotional problems. We recruited men aged 18 years or over who were not at risk of suicide to participate in a double-blind randomised controlled trial. Participants were randomly assigned (1:1) via computer randomisation to view Man Up (the intervention) or a control documentary. We hypothesised that 4 weeks after viewing Man Up participants would report higher levels of intention to seek help than those who viewed the control documentary. Our primary outcome was assessed using the General Help Seeking Questionnaire, and was analysed for all participants. The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12616001169437, Universal Trial Number: U1111-1186-1459) and was funded by the Movember Foundation. Three hundred and fifty-four men were assessed for eligibility for the trial and randomised to view Man Up or the control documentary. Of these, 337 completed all stages (nine participants were lost to follow-up in the intervention group and eight in the control group). Linear regression analysis showed a significant increase in intentions to seek help in the intervention group, but not in the control group (coef.=2.06, 95% CI 0.48 to 3.63, P=0.01). Our trial demonstrates the potential for men's health outcomes to be positively impacted by novel, media-based public health interventions that focus on traditional masculinity. ACTRN12616001169437, Results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Sleep Quality of Call Handlers Employed in International Call Centers in National Capital Region of Delhi, India.

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Raja, J D; Bhasin, S K

2016-10-01

Call center sector in India is a relatively new and fast growing industry driving employment and growth in modern India today. Most international call centers in National Capital Region (NCR) of Delhi operate at odd work hours corresponding to a time suitable fortheir international customers. The sleep quality of call handlers employed in these call centers is in jeopardy owing to their altered sleep schedule. To assess the sleep quality and determine its independent predictors among call handlers employed in international call centers in NCR of Delhi. A cross-sectional questionnaire-based study was conducted on 375 call handlers aged 18-39 years employed in international call centers in NCR of Delhi. Sleep quality was assessed using Athens Insomnia scale along with a pre-tested, structured questionnaire. The mean age of respondents was 24.6 (SD 2.4) years. 78% of participants were male. 83.5% of respondents were unmarried. 44.3% of call handlers were cigarette smokers. Physical ailments were reported by 37% call handlers. 77.6% of call handlers had somesuspicion of insomnia or suspected insomnia; the rest had no sleep problem. Smoking, poor social support, heavy workload, lack of relaxation facility at office, and prolonged travel time to office were independent predictors of sleep quality (pSafeguarding their health becomes an occupational health challenge to public health specialists.

1What do first-time mothers worry about? A study of usage patterns and content of calls made to a postpartum support telephone hotline

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Naassan Georges

2010-10-01

Full Text Available Abstract Background Telephone hotlines designed to address common concerns in the early postpartum could be a useful resource for parents. Our aim was to test the feasibility of using a telephone as an intervention in a randomized controlled trial. We also aimed to test to use of algorithms to address parental concerns through a telephone hotline. Methods Healthy first-time mothers were recruited from postpartum wards of hospitals throughout Lebanon. Participants were given the number of a 24-hour telephone hotline that they could access for the first four months after delivery. Calls were answered by a midwife using algorithms developed by the study team whenever possible. Callers with medical complaints were referred to their physicians. Call patterns and content were recorded and analyzed. Results Eighty-four of the 353 women enrolled (24% used the hotline. Sixty percent of the women who used the service called more than once, and all callers reported they were satisfied with the service. The midwife received an average of three calls per day and most calls occurred during the first four weeks postpartum. Our algorithms were used to answer questions in 62.8% of calls and 18.6% of calls required referral to a physician. Of the questions related to mothers, 66% were about breastfeeding. Sixty percent of questions related to the infant were about routine care and 23% were about excessive crying. Conclusions Utilization of a telephone hotline service for postpartum support is highest in the first four weeks postpartum. Most questions are related to breastfeeding, routine newborn care, and management of a fussy infant. It is feasible to test a telephone hotline as an intervention in a randomized controlled trial. Algorithms can be developed to provide standardized answers to the most common questions.

[Microdose clinical trial--impact of PET molecular imaging].

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Yano, Tsuneo; Watanabe, Yasuyoshi

2010-10-01

Microdose (MD) clinical trial and exploratory IND study including sub-therapeutic dose and therapeutic dose which are higher than microdoses are expected to bring about innovations in drug development. The outlines of guidances for microdose clinical trial and ICH-M3 (R2) issued by the MHLW in June, 2008, and February, 2010, are first explained, respectively, and some examples of their application to clinical developments of therapeutic drugs in the infection and cancer fields are introduced. Especially, thanks to the progress of molecular imaging research, a new field of drug development is explored by using imaging biomarkers for efficacy or safety evaluation which visualize biomarkers by PET imaging agents. Finally, the roadmap for drug development in infection and cancer fields utilizing PET molecular imaging is discussed.

Callings and Organizational Behavior

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Elangovan, A. R.; Pinder, Craig C.; McLean, Murdith

2010-01-01

Current literature on careers, social identity and meaning in work tends to understate the multiplicity, historical significance, and nuances of the concept of calling(s). In this article, we trace the evolution of the concept from its religious roots into secular realms and develop a typology of interpretations using occupation and religious…

Uncertain call likelihood negatively affects sleep and next-day cognitive performance while on-call in a laboratory environment.

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Sprajcer, Madeline; Jay, Sarah M; Vincent, Grace E; Vakulin, Andrew; Lack, Leon; Ferguson, Sally A

2018-05-11

On-call working arrangements are employed in a number of industries to manage unpredictable events, and often involve tasks that are safety- or time-critical. This study investigated the effects of call likelihood during an overnight on-call shift on self-reported pre-bed anxiety, sleep and next-day cognitive performance. A four-night laboratory-based protocol was employed, with an adaptation, a control and two counterbalanced on-call nights. On one on-call night, participants were instructed that they would definitely be called during the night, while on the other on-call night they were told they may be called. The State-Trait Anxiety Inventory form x-1 was used to investigate pre-bed anxiety, and sleep was assessed using polysomnography and power spectral analysis of the sleep electroencephalographic analysis. Cognitive performance was assessed four times daily using a 10-min psychomotor vigilance task. Participants felt more anxious before bed when they were definitely going to be called, compared with the control and maybe conditions. Conversely, participants experienced significantly less non-rapid eye movement and stage two sleep and poorer cognitive performance when told they may be called. Further, participants had significantly more rapid eye movement sleep in the maybe condition, which may be an adaptive response to the stress associated with this on-call condition. It appears that self-reported anxiety may not be linked with sleep outcomes while on-call. However, this research indicates that it is important to take call likelihood into consideration when constructing rosters and risk-management systems for on-call workers.

Calling in sick: impacts of fever on intra-urban human mobility.

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Perkins, T Alex; Paz-Soldan, Valerie A; Stoddard, Steven T; Morrison, Amy C; Forshey, Brett M; Long, Kanya C; Halsey, Eric S; Kochel, Tadeusz J; Elder, John P; Kitron, Uriel; Scott, Thomas W; Vazquez-Prokopec, Gonzalo M

2016-07-13

Pathogens inflict a wide variety of disease manifestations on their hosts, yet the impacts of disease on the behaviour of infected hosts are rarely studied empirically and are seldom accounted for in mathematical models of transmission dynamics. We explored the potential impacts of one of the most common disease manifestations, fever, on a key determinant of pathogen transmission, host mobility, in residents of the Amazonian city of Iquitos, Peru. We did so by comparing two groups of febrile individuals (dengue-positive and dengue-negative) with an afebrile control group. A retrospective, semi-structured interview allowed us to quantify multiple aspects of mobility during the two-week period preceding each interview. We fitted nested models of each aspect of mobility to data from interviews and compared models using likelihood ratio tests to determine whether there were statistically distinguishable differences in mobility attributable to fever or its aetiology. Compared with afebrile individuals, febrile study participants spent more time at home, visited fewer locations, and, in some cases, visited locations closer to home and spent less time at certain types of locations. These multifaceted impacts are consistent with the possibility that disease-mediated changes in host mobility generate dynamic and complex changes in host contact network structure. © 2016 The Author(s).

Recruitment strategy cost and impact on minority accrual to a breast cancer prevention trial.

Science.gov (United States)

Dew, Alexander; Khan, Seema; Babinski, Christie; Michel, Nancy; Heffernan, Marie; Stephan, Stefanie; Jordan, Neil; Jovanovic, Borko; Carney, Paula; Bergan, Raymond

2013-04-01

Recruitment of minorities to cancer prevention trials is difficult and costly. Early-phase cancer prevention trials have fewer resources to promote recruitment. Identifying cost-effective strategies that can replace or supplement traditional recruitment methods and improve minority accrual to small, early-phase cancer prevention trials are of critical importance. To compare the costs of accrual strategies used in a small breast cancer prevention trial and assess their impact on recruitment and minority accrual. A total of 1196 potential subjects with a known recruitment source contacted study coordinators about the SOY study, a breast cancer prevention trial. Recruitment strategies for this study included recruitment from within the Northwestern University network (internal strategy), advertisements placed on public transportation (Chicago Transit Authority (CTA)), health-related events, media (print/radio/television), and direct mail. Total recruitment strategy cost included the cost of study personnel and material costs calculated from itemized receipts. Incremental cost-effectiveness ratios (ICERs) were calculated to compare the relative cost-effectiveness of each recruitment strategy. If a strategy was more costly and less effective than its comparator, then that strategy was considered dominated. Scenarios that were not dominated were compared. The primary effectiveness measure was the number of consents. Separate ICERs were calculated using the number of minority consents as the effectiveness measure. The total cost of SOY study recruitment was US$164,585, which included the cost of materials (US$26,133) and personnel (US$138,452). The internal referral strategy was the largest source of trial contacts (748/1196; 63%), consents (107/150; 71%), and minority consents (17/34; 50%) and was the most expensive strategy (US$139,033). CTA ads generated the second largest number of trial contacts (326/1196; 27%), the most minority contacts (184/321; 57%), and 16

Impact on caesarean section rates following injections of sterile water (ICARIS): a multicentre randomised controlled trial.

Science.gov (United States)

Lee, Nigel; Mårtensson, Lena B; Homer, Caroline; Webster, Joan; Gibbons, Kristen; Stapleton, Helen; Dos Santos, Natalie; Beckmann, Michael; Gao, Yu; Kildea, Sue

2013-05-03

maternity populations outside Australia. In summary, the results of this trial will contribute High level evidence on the impact of SWI on intrapartum CS rates and provide evidence of the analgesic effect of SWI on back pain.

Skeletal-related events significantly impact health-related quality of life in metastatic castration-resistant prostate cancer: data from PREVAIL and AFFIRM trials.

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Saad, F; Ivanescu, C; Phung, D; Loriot, Y; Abhyankar, S; Beer, T M; Tombal, B; Holmstrom, S

2017-03-01

We investigated the impact of skeletal-related events (SREs) on health-related quality of life (HRQoL) in patients with metastatic castration-resistant prostate cancer (mCRPC) in phase III trials of enzalutamide versus placebo. Patients with mCRPC experiencing at least one SRE during AFFIRM and PREVAIL were assessed for trajectory-adjusted mean change in HRQoL by first SRE using Functional Assessment of Cancer Therapy-Prostate (FACT-P; AFFIRM, three domains, and PREVAIL, nine domains) and EQ-5D (PREVAIL) instruments. First SREs caused HRQoL deterioration in both trials. Spinal cord compression had the largest impact, with clinically meaningful reductions in seven of nine FACT-P domains in PREVAIL and all three in AFFIRM (mean (95% confidence interval (CI)) change in FACT-P total score -16.95 (-26.47, -7.44) and -9.69 (-16.10, -3.27), respectively). In PREVAIL, first SREs caused clinically meaningful declines in EQ-5D utility index, irrespective of category; spinal cord compression had the largest impact (mean (95% CI) change -0.24 (-0.39, -0.08)). In AFFIRM, FACT-P and FACT-General total scores showed clinically meaningful declines after radiation/surgery to bone. SREs were associated with clinically meaningful functional declines in the daily lives of patients with mCRPC. Spinal cord compression had the largest impact on HRQoL.

Efficient design of clinical trials and epidemiological research: is it possible?

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Lauer, Michael S; Gordon, David; Wei, Gina; Pearson, Gail

2017-08-01

Randomized clinical trials and large-scale, cohort studies continue to have a critical role in generating evidence in cardiovascular medicine; however, the increasing concern is that ballooning costs threaten the clinical trial enterprise. In this Perspectives article, we discuss the changing landscape of clinical research, and clinical trials in particular, focusing on reasons for the increasing costs and inefficiencies. These reasons include excessively complex design, overly restrictive inclusion and exclusion criteria, burdensome regulations, excessive source-data verification, and concerns about the effect of clinical research conduct on workflow. Thought leaders have called on the clinical research community to consider alternative, transformative business models, including those models that focus on simplicity and leveraging of digital resources. We present some examples of innovative approaches by which some investigators have successfully conducted large-scale, clinical trials at relatively low cost. These examples include randomized registry trials, cluster-randomized trials, adaptive trials, and trials that are fully embedded within digital clinical care or administrative platforms.

A call for improved transparency in financial aspects of clinical trials: a case study of the CREATE-X trial in the New England Journal of Medicine.

Science.gov (United States)

Ozaki, Akihiko; Takita, Morihito; Tanimoto, Tetsuya

2018-06-01

Introduction Globally, laws and guidelines for managing conflict of interest are increasingly implemented to achieve transparency in financial ties between physicians and pharmaceutical and medical device industries, yet little information is available regarding the limitations of the current frameworks for disclosing these financial ties. Case In June 2017, the Capecitabine for Residual Cancer as Adjuvant Therapy (CREATE-X) trial was published in the New England Journal of Medicine. In this study, which suggested the post-surgery addition of capecitabine would improve survival of high-risk breast cancer patients, the cost of capecitabine for off-label use was illegally claimed to the Japanese public health insurance system, rather than being covered by the research budget. This illegal claim led to the profit of more than 100,000,000 JPY (approximately 0.91 million USD) for Chugai Pharmaceutical Company (CPC), which manufactures capecitabine. Additional evidence suggests that the CPC made donations of at least 100,000,000 JPY (approximately 0.91 million USD) and 236,000,000 JPY (approximately 2.1 million USD) to the Japan Breast Cancer Research Group (JBCRG), the study's sponsor and funder where the majority of the Japanese authors served high-level positions, and the Advanced Clinical Research Organization, the other study funder, respectively, during the study period, though the total amount has not been clarified. Neither the CPC's involvement nor its undue profit was mentioned in the published article. Conclusion This case report highlights the lack of financial transparency in the CREATE-X trial, and discusses the potential limitations that may exist in the current frameworks for disclosing financial ties between physicians and relevant industries in clinical trials. Achieving improved transparency is essential to heighten credibility in the findings of clinical trials.

Care and calls

DEFF Research Database (Denmark)

Paasch, Bettina Sletten

-centred care through the use of tactile resources and embodied orientations while they attend to the phone call. Experienced nurses Thus perform multiactivity by distributing attention towards both the patient and the phone, and the analysis shows that their concrete ways of doing so depend on the complex...... they are telephoned during interactions with patients are not universal. Indeed different strategies have evolved in other hospital departments. Not only does this thesis contribute insights into the way nurses manage phone calls during interactions with patients, but by subscribing to a growing body of embodied...... of human interaction....

Ovarian cancer clinical trial endpoints: Society of Gynecologic Oncology white paper

Science.gov (United States)

Herzog, Thomas J.; Armstrong, Deborah K.; Brady, Mark F.; Coleman, Robert L.; Einstein, Mark H.; Monk, Bradley J.; Mannel, Robert S.; Thigpen, J. Tate; Umpierre, Sharee A.; Villella, Jeannine A.; Alvarez, Ronald D.

2015-01-01

Objective To explore the value of multiple clinical endpoints in the unique setting of ovarian cancer. Methods A clinical trial workgroup was established by the Society of Gynecologic Oncology to develop a consensus statement via multiple conference calls, meetings and white paper drafts. Results Clinical trial endpoints have profound effects on late phase clinical trial design, result interpretation, drug development, and regulatory approval of therapeutics. Selection of the optimal clinical trial endpoint is particularly provocative in ovarian cancer where long overall survival (OS) is observed. The lack of new regulatory approvals and the lack of harmony between regulatory bodies globally for ovarian cancer therapeutics are of concern. The advantages and disadvantages of the numerous endpoints available are herein discussed within the unique context of ovarian cancer where both crossover and post-progression therapies potentially uncouple surrogacy between progression-free survival (PFS) and OS, the two most widely supported and utilized endpoints. The roles of patient reported outcomes (PRO) and health related quality of life (HRQoL) are discussed, but even these widely supported parameters are affected by the unique characteristics of ovarian cancer where a significant percentage of patients may be asymptomatic. Original data regarding the endpoint preferences of ovarian cancer advocates is presented. Conclusions Endpoint selection in ovarian cancer clinical trials should reflect the impact on disease burden and unique characteristics of the treatment cohort while reflecting true patient benefit. Both OS and PFS have led to regulatory approvals and are clinically important. OS remains the most objective and accepted endpoint because it is least vulnerable to bias; however, the feasibility of OS in ovarian cancer is compromised by the requirement for large trial size, prolonged time-line for final analysis, and potential for unintended loss of treatment effect

Ovarian cancer clinical trial endpoints: Society of Gynecologic Oncology white paper.

Science.gov (United States)

Herzog, Thomas J; Armstrong, Deborah K; Brady, Mark F; Coleman, Robert L; Einstein, Mark H; Monk, Bradley J; Mannel, Robert S; Thigpen, J Tate; Umpierre, Sharee A; Villella, Jeannine A; Alvarez, Ronald D

2014-01-01

To explore the value of multiple clinical endpoints in the unique setting of ovarian cancer. A clinical trial workgroup was established by the Society of Gynecologic Oncology to develop a consensus statement via multiple conference calls, meetings and white paper drafts. Clinical trial endpoints have profound effects on late phase clinical trial design, result interpretation, drug development, and regulatory approval of therapeutics. Selection of the optimal clinical trial endpoint is particularly provocative in ovarian cancer where long overall survival (OS) is observed. The lack of new regulatory approvals and the lack of harmony between regulatory bodies globally for ovarian cancer therapeutics are of concern. The advantages and disadvantages of the numerous endpoints available are herein discussed within the unique context of ovarian cancer where both crossover and post-progression therapies potentially uncouple surrogacy between progression-free survival (PFS) and OS, the two most widely supported and utilized endpoints. The roles of patient reported outcomes (PRO) and health related quality of life (HRQoL) are discussed, but even these widely supported parameters are affected by the unique characteristics of ovarian cancer where a significant percentage of patients may be asymptomatic. Original data regarding the endpoint preferences of ovarian cancer advocates is presented. Endpoint selection in ovarian cancer clinical trials should reflect the impact on disease burden and unique characteristics of the treatment cohort while reflecting true patient benefit. Both OS and PFS have led to regulatory approvals and are clinically important. OS remains the most objective and accepted endpoint because it is least vulnerable to bias; however, the feasibility of OS in ovarian cancer is compromised by the requirement for large trial size, prolonged time-line for final analysis, and potential for unintended loss of treatment effect from active post-progression therapies

The cost-effectiveness and budget impact of stepwise addition of bolus insulin in the treatment of type 2 diabetes: evaluation of the FullSTEP trial.

Science.gov (United States)

Saunders, Rhodri; Lian, Jean; Karolicki, Boris; Valentine, William

2014-12-01

Abstract Background and aims: Intensification of basal insulin-only therapy in type 2 diabetes is often achieved through addition of bolus insulin 3-times daily. The FullSTEP trial demonstrated that stepwise addition (SWA) of bolus insulin aspart was non-inferior to full basal-bolus (FBB) therapy and reduced the rate of hypoglycemia. Here the cost-effectiveness and budget impact of SWA is evaluated. Cost-effectiveness and budget impact models were developed to assess the cost and quality-of-life (QoL) implications of intensification using SWA compared with FBB in the US setting. At assessment, SWA patients added one bolus dose to their current regimen if the HbA1c target was not met. SWA patients reaching three bolus doses used FBB event rates. Outcomes were evaluated at trial end and projected annually up to 5 years. Models captured hypoglycemic events, the proportion meeting HbA1c target, and self-measured blood glucose. Event rates and QoL utilities were taken from trial data and published literature. Costs were evaluated from a healthcare-payer perspective, reported in 2013 USD, and discounted (like clinical outcomes) at 3.5% annually. This analysis applies to patients with HbA1c 7.0-9.0% and body mass index Budget impact analysis estimated that, by moving from FBB to SWA, a health plan with 77,000 patients with type 2 diabetes, of whom 7.8% annually intensified to basal-bolus therapy, would save USD 1304 per intensifying patient over the trial period. SWA of bolus insulin should be considered a beneficial and cost-saving alternative to FBB therapy for the intensification of treatment in type 2 diabetes.

The impact of text message reminders on adherence to antimalarial treatment in northern Ghana: a randomized trial.

Directory of Open Access Journals (Sweden)

Julia R G Raifman

Full Text Available BACKGROUND: Low rates of adherence to artemisinin-based combination therapy (ACT regimens increase the risk of treatment failure and may lead to drug resistance, threatening the sustainability of current anti-malarial efforts. We assessed the impact of text message reminders on adherence to ACT regimens. METHODS: Health workers at hospitals, clinics, pharmacies, and other stationary ACT distributors in Tamale, Ghana provided flyers advertising free mobile health information to individuals receiving malaria treatment. The messaging system automatically randomized self-enrolled individuals to the control group or the treatment group with equal probability; those in the treatment group were further randomly assigned to receive a simple text message reminder or the simple reminder plus an additional statement about adherence in 12-hour intervals. The main outcome was self-reported adherence based on follow-up interviews occurring three days after treatment initiation. We estimated the impact of the messages on treatment completion using logistic regression. RESULTS: 1140 individuals enrolled in both the study and the text reminder system. Among individuals in the control group, 61.5% took the full course of treatment. The simple text message reminders increased the odds of adherence (adjusted OR 1.45, 95% CI [1.03 to 2.04], p-value 0.028. Receiving an additional message did not result in a significant change in adherence (adjusted OR 0.77, 95% CI [0.50 to 1.20], p-value 0.252. CONCLUSION: The results of this study suggest that a simple text message reminder can increase adherence to antimalarial treatment and that additional information included in messages does not have a significant impact on completion of ACT treatment. Further research is needed to develop the most effective text message content and frequency. TRIAL REGISTRATION: ClinicalTrials.gov NCT01722734.

Anthropogenic noise alters bat activity levels and echolocation calls

Directory of Open Access Journals (Sweden)

Jessie P. Bunkley

2015-01-01

Full Text Available Negative impacts from anthropogenic noise are well documented for many wildlife taxa. Investigations of the effects of noise on bats however, have not been conducted outside of the laboratory. Bats that hunt arthropods rely on auditory information to forage. Part of this acoustic information can fall within the spectrum of anthropogenic noise, which can potentially interfere with signal reception and processing. Compressor stations associated with natural gas extraction produce broadband noise 24 hours a day, 365 days a year. With over half a million producing gas wells in the U.S. this infrastructure is a major source of noise pollution across the landscape. We conducted a ‘natural experiment’ in the second largest gas extraction field in the U.S. to investigate the potential effects of gas compressor station noise on the activity levels of the local bat assemblage. We used acoustic monitoring to compare the activity level (number of minutes in a night with a bat call of the bat assemblage at sites with compressor stations to sites lacking this infrastructure. We found that activity levels for the Brazilian free-tailed bat (Tadarida brasiliensis were 40% lower at loud compressor sites compared to quieter well pads, whereas the activity levels of four other species (Myotis californicus, M. cillolabrum, M. lucifugus, Parastrellus hesperus were not affected by noise. Furthermore, our results reveal that the assemblage of bat species emitting low frequency (35 kHz echolocation did not exhibit altered activity levels in noise. Lower activity levels of Brazilian free-tailed bats at loud sites indicate a potential reduction in habitat for this species. Additionally, a comparison of echolocation search calls produced by free-tailed bats at sites with and without compressor stations reveal that this species modifies its echolocation search calls in noise—producing longer calls with a narrower bandwidth. Call alterations might affect prey

Comparison of reporting phase I trial results in ClinicalTrials.gov and matched publications.

Science.gov (United States)

Shepshelovich, D; Goldvaser, H; Wang, L; Abdul Razak, A R; Bedard, P L

2017-12-01

Background Data on completeness of reporting of phase I cancer clinical trials in publications are lacking. Methods The ClinicalTrials.gov database was searched for completed adult phase I cancer trials with reported results. PubMed was searched for matching primary publications published prior to November 1, 2016. Reporting in primary publications was compared with the ClinicalTrials.gov database using a 28-point score (2=complete; 1=partial; 0=no reporting) for 14 items related to study design, outcome measures and safety profile. Inconsistencies between primary publications and ClinicalTrials.gov were recorded. Linear regression was used to identify factors associated with incomplete reporting. Results After a review of 583 trials in ClinicalTrials.gov , 163 matching primary publications were identified. Publications reported outcomes that did not appear in ClinicalTrials.gov in 25% of trials. Outcomes were upgraded, downgraded or omitted in publications in 47% of trials. The overall median reporting score was 23/28 (interquartile range 21-25). Incompletely reported items in >25% publications were: inclusion criteria (29%), primary outcome definition (26%), secondary outcome definitions (53%), adverse events (71%), serious adverse events (80%) and dates of study start and database lock (91%). Higher reporting scores were associated with phase I (vs phase I/II) trials (ppublication in journals with lower impact factor (p=0.004). Conclusions Reported results in primary publications for early phase cancer trials are frequently inconsistent or incomplete compared with ClinicalTrials.gov entries. ClinicalTrials.gov may provide more comprehensive data from new cancer drug trials.

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,…

Impact of more intensive written information in patients having radical radiation therapy: Results of a prospective randomized phase III trial

International Nuclear Information System (INIS)

Zissiadis, Yvonne; Harper, Emily; Kearney, Elizabeth

2010-01-01

Background and purpose: A diagnosis of malignancy and its treatment is a very stressful time for patients and their families. This study was conducted to determine the impact of more intensive written information on patients' anxiety levels. The secondary aim was to determine the impact of this information on patients' satisfaction levels. Materials and methods: This prospective randomized trial consisted of patients with a pathological diagnosis of cancer having radical radiotherapy (RT). Patients were randomized to receive the more intensive information (including written information and a telephone call from the research nurse) or not to receive the more intensive information at the time of their initial consultation with the radiation oncologist. Study questionnaires measuring anxiety (STAI form) were completed prior to their first consultation (baseline) at the time of simulation (pre-RT) and at the completion of radiotherapy. A second questionnaire assessing satisfaction with the information given (ISQ) was completed at the time of simulation prior to commencing RT. Results: One hundred and ninety-four patients were enrolled in the study. The mean age of the patients was 58.5 years and 70% of patients were female. Breast cancer (67%) was the commonest cancer. One hundred and two patients were randomized to receive the intensive information package and 92 patients received the standard consultation. There was no significant difference in mean State or Trait anxiety scores between any of the time intervals and no difference between the two information groups. There was no significant difference between the groups with regard to mean satisfaction scores with the overall information given, nor with any individual question. The satisfaction scores with lifestyle information given were lower than those for any other type of information in both randomization arms. Conclusion: More intensive information did not significantly change patients' anxiety scores or

Impact of Contextual Factors on the Effect of Interventions to Improve Health Worker Performance in Sub-Saharan Africa: Review of Randomised Clinical Trials.

Science.gov (United States)

Blacklock, Claire; Gonçalves Bradley, Daniela C; Mickan, Sharon; Willcox, Merlin; Roberts, Nia; Bergström, Anna; Mant, David

2016-01-01

Africa bears 24% of the global burden of disease but has only 3% of the world's health workers. Substantial variation in health worker performance adds to the negative impact of this significant shortfall. We therefore sought to identify interventions implemented in sub-Saharan African aiming to improve health worker performance and the contextual factors likely to influence local effectiveness. A systematic search for randomised controlled trials of interventions to improve health worker performance undertaken in sub-Saharan Africa identified 41 eligible trials. Data were extracted to define the interventions' components, calculate the absolute improvement in performance achieved, and document the likelihood of bias. Within-study variability in effect was extracted where reported. Statements about contextual factors likely to have modified effect were subjected to thematic analysis. Interventions to improve health worker performance can be very effective. Two of the three trials assessing mortality impact showed significant reductions in death rates (age<5 case fatality 5% versus 10%, p<0.01; maternal in-hospital mortality 6.8/1000 versus 10.3/1000; p<0.05). Eight of twelve trials focusing on prescribing had a statistically significant positive effect, achieving an absolute improvement varying from 9% to 48%. However, reported range of improvement between centres within trials varied substantially, in many cases exceeding the mean effect. Nine contextual themes were identified as modifiers of intervention effect across studies; most frequently cited were supply-line failures, inadequate supervision or management, and failure to follow-up training interventions with ongoing support, in addition to staff turnover. Interventions to improve performance of existing staff and service quality have the potential to improve patient care in underserved settings. But in order to implement interventions effectively, policy makers need to understand and address the contextual

Reducing the environmental impact of trials: a comparison of the carbon footprint of the CRASH-1 and CRASH-2 clinical trials

Science.gov (United States)

2011-01-01

Background All sectors of the economy, including the health research sector, must reduce their carbon emissions. The UK National Institute for Health Research has recently prepared guidelines on how to minimize the carbon footprint of research. We compare the carbon emissions from two international clinical trials in order to identify where emissions reductions can be made. Methods We conducted a carbon audit of two clinical trials (the CRASH-1 and CRASH-2 trials), quantifying the carbon dioxide emissions produced over a one-year audit period. Carbon emissions arising from the coordination centre, freight delivery, trial-related travel and commuting were calculated and compared. Results The total emissions in carbon dioxide equivalents during the one-year audit period were 181.3 tonnes for CRASH-1 and 108.2 tonnes for CRASH-2. In total, CRASH-1 emitted 924.6 tonnes of carbon dioxide equivalents compared with 508.5 tonnes for CRASH-2. The CRASH-1 trial recruited 10,008 patients over 5.1 years, corresponding to 92 kg of carbon dioxide per randomized patient. The CRASH-2 trial recruited 20,211 patients over 4.7 years, corresponding to 25 kg of carbon dioxide per randomized patient. The largest contributor to emissions in CRASH-1 was freight delivery of trial materials (86.0 tonnes, 48% of total emissions), whereas the largest contributor in CRASH-2 was energy use by the trial coordination centre (54.6 tonnes, 30% of total emissions). Conclusions Faster patient recruitment in the CRASH-2 trial largely accounted for its greatly increased carbon efficiency in terms of emissions per randomized patient. Lighter trial materials and web-based data entry also contributed to the overall lower carbon emissions in CRASH-2 as compared to CRASH-1. Trial Registration Numbers CRASH-1: ISRCTN74459797 CRASH-2: ISRCTN86750102 PMID:21291517

Reducing the environmental impact of trials: a comparison of the carbon footprint of the CRASH-1 and CRASH-2 clinical trials

Directory of Open Access Journals (Sweden)

Roberts Ian

2011-02-01

Full Text Available Abstract Background All sectors of the economy, including the health research sector, must reduce their carbon emissions. The UK National Institute for Health Research has recently prepared guidelines on how to minimize the carbon footprint of research. We compare the carbon emissions from two international clinical trials in order to identify where emissions reductions can be made. Methods We conducted a carbon audit of two clinical trials (the CRASH-1 and CRASH-2 trials, quantifying the carbon dioxide emissions produced over a one-year audit period. Carbon emissions arising from the coordination centre, freight delivery, trial-related travel and commuting were calculated and compared. Results The total emissions in carbon dioxide equivalents during the one-year audit period were 181.3 tonnes for CRASH-1 and 108.2 tonnes for CRASH-2. In total, CRASH-1 emitted 924.6 tonnes of carbon dioxide equivalents compared with 508.5 tonnes for CRASH-2. The CRASH-1 trial recruited 10,008 patients over 5.1 years, corresponding to 92 kg of carbon dioxide per randomized patient. The CRASH-2 trial recruited 20,211 patients over 4.7 years, corresponding to 25 kg of carbon dioxide per randomized patient. The largest contributor to emissions in CRASH-1 was freight delivery of trial materials (86.0 tonnes, 48% of total emissions, whereas the largest contributor in CRASH-2 was energy use by the trial coordination centre (54.6 tonnes, 30% of total emissions. Conclusions Faster patient recruitment in the CRASH-2 trial largely accounted for its greatly increased carbon efficiency in terms of emissions per randomized patient. Lighter trial materials and web-based data entry also contributed to the overall lower carbon emissions in CRASH-2 as compared to CRASH-1. Trial Registration Numbers CRASH-1: ISRCTN74459797 CRASH-2: ISRCTN86750102

Sleep Disordered Breathing in Chronic SCI: A Randomized Controlled Trial of Treatment Impact on Cognition, Quality of Life, and Cardiovascular Disease

Science.gov (United States)

2016-10-01

Cognition, Quality of Life, and Cardiovascular Disease PRINCIPAL INVESTIGATOR: Shirin Shafazand, MD, MS CONTRACTING ORGANIZATION: University of Miami...with positive airway pressure (PAP) will improve cognitive impairment, sleep quality, quality of life, and cardiovascular disease (CVD) surrogate...Randomized Controlled Trial of Treatment Impact on Cognition, Quality of Life, and Cardiovascular Disease Shirin Shafazand, MD, MS Nothing listed 12

How to call the Fire Brigade

CERN Multimedia

2003-01-01

The telephone numbers for the CERN Fire Brigade are: 74444 for emergency calls 74848 for other calls Note The number 112 will stay in use for emergency calls from "wired" telephones, however, from mobile phones it leads to non-CERN emergency services.

GUARANTEES OF THE RIGHT TO A FAIR CIVIL TRIAL

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Diana-Loredana Jalbă

2015-11-01

Full Text Available In order to ensure the effective protection of human rights and provide for more than theoretical and illusory substantive rights, the need to define the right to a fair trial is emerging, along with the necessity that litigants become aware of the guarantees established by article 6 of the European Convention on Human Rights. Thus, the article aims to approach the ample issue regarding the litigants’ right to a fair civil trial in light of current legal regulations, and in particular, in light of the jurisprudence of the European Court of Human Rights. Given the fact that the right to a fair civil trial involves establishing, throughout the trial, a set of rules of procedure aimed at creating a balance between the parties in the process - the so-called guarantees of a fair trial - in her scientific pursuits, the author analyzes both explicit and implicit guarantees of fair trial, highlighting relevant European standards as well as their degree of implementation in the national (procedural law.

Maximizing the Impact of e-Therapy and Serious Gaming: Time for a Paradigm Shift.

Science.gov (United States)

Fleming, Theresa M; de Beurs, Derek; Khazaal, Yasser; Gaggioli, Andrea; Riva, Giuseppe; Botella, Cristina; Baños, Rosa M; Aschieri, Filippo; Bavin, Lynda M; Kleiboer, Annet; Merry, Sally; Lau, Ho Ming; Riper, Heleen

2016-01-01

Internet interventions for mental health, including serious games, online programs, and apps, hold promise for increasing access to evidence-based treatments and prevention. Many such interventions have been shown to be effective and acceptable in trials; however, uptake and adherence outside of trials is seldom reported, and where it is, adherence at least, generally appears to be underwhelming. In response, an international Collaboration On Maximizing the impact of E-Therapy and Serious Gaming (COMETS) was formed. In this perspectives' paper, we call for a paradigm shift to increase the impact of internet interventions toward the ultimate goal of improved population mental health. We propose four pillars for change: (1) increased focus on user-centered approaches, including both user-centered design of programs and greater individualization within programs, with the latter perhaps utilizing increased modularization; (2) Increased emphasis on engagement utilizing processes such as gaming, gamification, telepresence, and persuasive technology; (3) Increased collaboration in program development, testing, and data sharing, across both sectors and regions, in order to achieve higher quality, more sustainable outcomes with greater reach; and (4) Rapid testing and implementation, including the measurement of reach, engagement, and effectiveness, and timely implementation. We suggest it is time for researchers, clinicians, developers, and end-users to collaborate on these aspects in order to maximize the impact of e-therapies and serious gaming.

Maximizing the impact of e-therapy and serious gaming: Time for a paradigm shift

Directory of Open Access Journals (Sweden)

Theresa M Fleming

2016-04-01

Full Text Available Internet interventions for mental health, including serious games, online programs and apps, hold promise for increasing access to evidence-based treatments and prevention. Many such interventions have been shown to be effective and acceptable in trials; however, uptake and adherence outside of trials is seldom reported, and where it is, adherence at least, generally appears to be underwhelming. In response, an international Collaboration On Maximizing the impact of E-Therapy and Serious Gaming (COMETS was formed. In this perspectives paper, we call for a paradigm shift to increase the impact of internet interventions towards the ultimate goal of improved population mental health. We propose four pillars for change: 1. Increased focus on user-centered approaches, including both user-centered design of programs and greater individualization within programs, with the latter perhaps utilizing increased modulariziation. 2. Increased emphasis on engagement; utilizing processes such as gaming, gamification, telepresence, and persuasive technology. 3. Increased collaboration in program development, testing and data sharing, across both sectors and regions, in order to achieve higher quality, more sustainable outcomes with greater reach. 4. Rapid testing and implementation, including the measurement of reach, engagement and effectiveness, and timely implementation. We suggest it is time for researchers, clinicians, developers and end-users to collaborate on these aspects in order to maximize the impact of e-therapies and serious gaming.

Exposure Calls to U. S. Poison Centers Involving Electronic Cigarettes and Conventional Cigarettes-September 2010-December 2014.

Science.gov (United States)

Chatham-Stephens, Kevin; Law, Royal; Taylor, Ethel; Kieszak, Stephanie; Melstrom, Paul; Bunnell, Rebecca; Wang, Baoguang; Day, Hannah; Apelberg, Benjamin; Cantrell, Lee; Foster, Howell; Schier, Joshua G

2016-12-01

E-cigarette use is increasing, and the long-term impact on public health is unclear. We described the acute adverse health effects from e-cigarette exposures reported to U.S. poison centers. We compared monthly counts and demographic, exposure, and health effects data of calls about e-cigarettes and conventional cigarettes made to poison centers from September 2010 through December 2014. Monthly e-cigarette calls increased from 1 in September 2010, peaked at 401 in April 2014, and declined to 295 in December 2014. Monthly conventional cigarette calls during the same period ranged from 302 to 514. E-cigarette calls were more likely than conventional cigarette calls to report adverse health effects, including vomiting, eye irritation, and nausea. Five e-cigarette calls reported major health effects, such as respiratory failure, and there were two deaths associated with e-cigarette calls. E-cigarette calls to U.S. poison centers increased over the study period, and were more likely than conventional cigarettes to report adverse health effects. It is important for health care providers and the public to be aware of potential acute health effects from e-cigarettes. Developing strategies to monitor and prevent poisonings from these novel devices is critical.

The job demands-resources model of work engagement in South African call centres

Directory of Open Access Journals (Sweden)

Yolandi Janse van Rensburg

2013-09-01

Full Text Available Orientation: A ‘sacrificial human resource strategy’ is practised in call centres, resulting in poor employee occupational health. Consequently, questions are posed in terms of the consequences of call centre work and which salient antecedent variables impact the engagement and wellbeing of call centre representatives. Research purpose: Firstly, to gauge the level of employee engagement amongst a sample of call centre representatives in South Africa and, secondly, to track the paths through which salient personal and job resources affect this engagement. More specifically, the relationships between sense of coherence, leadership effectiveness, team effectiveness and engagement were investigated, thus testing the Job Demands-Resources model of work engagement. Motivation for the study: To present an application of the Job Demands-Resources model of work engagement in a call centre environment in order to diagnose current ills and consequently propose remedies. Research design: A cross-sectional survey design was used and a non-probability convenient sample of 217 call centre representatives was selected. The measuring instruments comprise the Utrecht Work Engagement Scale to measure engagement, the Team Diagnostic Survey to measure team effectiveness, the leadership practices inventory to gauge leadership effectiveness, and the Orientation to Life Questionnaire to measure sense of coherence. A series of structural equation modelling analyses were performed. Main findings: Contrary to the ‘electronic sweatshop’ image attached to call centre jobs depicted in the literature, results show a high level of employee engagement for call centre representatives in the sample. Also, personal resources such as sense of coherence and job resources such as team effectiveness related significantly to engagement. A non-significant relationship exists between leadership effectiveness and engagement. Practical/managerial implications: Both the content and

The job demands-resources model of work engagement in South African call centres

Directory of Open Access Journals (Sweden)

Yolandi Janse van Rensburg

2013-09-01

Full Text Available Orientation: A ‘sacrificial human resource strategy’ is practised in call centres, resulting in poor employee occupational health. Consequently, questions are posed in terms of the consequences of call centre work and which salient antecedent variables impact the engagement and wellbeing of call centre representatives.Research purpose: Firstly, to gauge the level of employee engagement amongst a sample of call centre representatives in South Africa and, secondly, to track the paths through which salient personal and job resources affect this engagement. More specifically, the relationships between sense of coherence, leadership effectiveness, team effectiveness and engagement were investigated, thus testing the Job Demands-Resources model of work engagement.Motivation for the study: To present an application of the Job Demands-Resources model of work engagement in a call centre environment in order to diagnose current ills and consequently propose remedies.Research design: A cross-sectional survey design was used and a non-probability convenient sample of 217 call centre representatives was selected. The measuring instruments comprise the Utrecht Work Engagement Scale to measure engagement, the Team Diagnostic Survey to measure team effectiveness, the leadership practices inventory to gauge leadership effectiveness, and the Orientation to Life Questionnaire to measure sense of coherence. A series of structural equation modelling analyses were performed.Main findings: Contrary to the ‘electronic sweatshop’ image attached to call centre jobs depicted in the literature, results show a high level of employee engagement for call centre representatives in the sample. Also, personal resources such as sense of coherence and job resources such as team effectiveness related significantly to engagement. A non-significant relationship exists between leadership effectiveness and engagement.Practical/managerial implications: Both the content and

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

Science.gov (United States)

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

2014-01-01

Evaluation of surrogate endpoints using patient-level data from multiple trials is the gold standard, where multi-trial copula models are used to quantify both patient-level and trial-level surrogacy. While limited consideration has been given in the literature to copula choice (e.g., Clayton), no prior consideration has been given to direction of implementation (via survival versus distribution functions). We demonstrate that evenwith the “correct” copula family, directional misspecification leads to biased estimates of patient-level and trial-level surrogacy. We illustrate with a simulation study and a re-analysis of disease-free survival as a surrogate for overall survival in early stage colon cancer. PMID:24905465

A Hierarchy of Patient-Reported Outcomes for Meta-Analysis of Knee Osteoarthritis Trials: Empirical Evidence from a Survey of High Impact Journals

Directory of Open Access Journals (Sweden)

Carsten Juhl

2012-01-01

Full Text Available Objectives. To develop a prioritised list based on responsiveness for extracting patient-reported outcomes (PROs measuring pain and disability for performing meta-analyses in knee osteoarthritis (OA. Methods. A systematic search was conducted in 20 highest impact factor general and rheumatology journals chosen a priori. Eligible studies were randomised controlled trials, using two or more PROs measuring pain and/or disability. Results. A literature search identified 402 publications and 38 trials were included, resulting in 54 randomised comparisons. Thirty-five trials had sufficient data on pain and 15 trials on disability. The WOMAC “pain” and “function” subscales were the most responsive composite scores. The following list was developed. Pain: (1 WOMAC “pain” subscale, (2 pain during activity (VAS, (3 pain during walking (VAS, (4 general knee pain (VAS, (5 pain at rest (VAS, (6 other composite pain scales, and (7 other single item measures. Disability: (1 WOMAC “function” subscale, (2 SF-36 “physical function” subscale, (3 SF-36 (Physical composite score, and (4 Other composite disability scores. Conclusions. As choosing the PRO most favourable for the intervention from individual trials can lead to biased estimates, using a prioritised list as developed in this study is recommended to reduce risk of biased selection of PROs in meta-analyses.

Psychophysiological effects of emotional display rules and the moderating role of trait anger in a simulated call center.

Science.gov (United States)

Rohrmann, Sonja; Bechtoldt, Myriam N; Hopp, Henrik; Hodapp, Volker; Zapf, Dieter

2011-07-01

In customer interactions, emotional display rules typically prescribe service providers to suppress negative emotions and display positive ones. This study investigated the causal impact of these emotional display rules on physiological indicators of workers' stress and performance. Additionally, the moderating influence of personality was examined by analyzing the impact of trait anger. In a simulated call center, 82 females were confronted with a complaining customer and instructed to react either authentically and show their true emotions or to "serve with a smile" and hide negative emotions. Increases in diastolic blood pressure and heart rates were higher in the smile condition, while verbal fluency was lower. Trait anger moderated the effects on diastolic blood pressure and observer ratings' of participants' professional competence, suggesting more negative effects for high trait anger individuals. Findings imply that emotional display rules may increase call center employees' strain and that considering employees' personality may be crucial for precluding health and performance impairments among call center workers.

Frequent callers to crisis helplines: who are they and why do they call?

Science.gov (United States)

Spittal, Matthew J; Fedyszyn, Izabela; Middleton, Aves; Bassilios, Bridget; Gunn, Jane; Woodward, Alan; Pirkis, Jane

2015-01-01

Frequent callers present a challenge for crisis helplines, which strive to achieve optimal outcomes for all callers within finite resources. This study aimed to describe frequent callers to Lifeline (the largest crisis helpline in Australia) and compare them with non-frequent callers, with a view to furthering knowledge about models of service delivery that might meet the needs of frequent callers. Lifeline provided an anonymous dataset on calls made between December 2011 and May 2013. We assumed calls from the same (encrypted) phone number were made by the same person, and aggregated call level data up to the person level. Individuals who made 0.667 calls per day in any period from 1 week to the full 549 days for which we had data (i.e. 4.7 calls in 7 days, 20 calls in 30 days, 40 calls in 60 days, etc.) were regarded as frequent callers. Our analysis dataset included 411,725 calls made by 98,174 individuals, 2594 (2.6%) of whom met our definition of frequent callers. We identified a number of predictors of being a frequent caller, including being male or transgender, and never having been married. The odds increased with age until 55-64 years, and then declined. Suicidality, self-harm, mental health issues, crime, child protection and domestic violence issues all predicted being a frequent caller. Collectively, frequent callers have a significant impact on crisis lines, and solutions need to be found for responding to them that are in everybody's best interests (i.e. the frequent callers themselves, other callers, telephone crisis supporters who staff crisis lines, and those who manage crisis lines). In striking this balance, the complex and multiple needs of frequent callers must be taken into account. © The Royal Australian and New Zealand College of Psychiatrists 2014.

Using Semantic Similarity In Automated Call Quality Evaluator For Call Centers

Directory of Open Access Journals (Sweden)

Ria A. Sagum

2015-08-01

Full Text Available Conversation between the agent and client are being evaluated manually by a quality assurance officer QA. This job is only one of the responsibilities being done by a QA and particularly eat ups a lot of time for them which lead to late evaluation results that may cause untimely response of the company to concerns raised by their clients. This research developed an application software that automates and evaluates the quality assurance in business process outsourcing companies or customer service management implementing sentence similarity. The developed system includes two modules speaker diarization which includes transcription and question and answer extraction and similarity checker which checks the similarity between the extracted answer and the answer of the call center agent to a question. The system was evaluated for Correctness of the extracted answers and accurateness of the evaluation for a particular call. Audio conversations were tested for the accuracy of the transcription module which has an accuracy of 27.96. The Precision Recall and F-measure of the extracted answer was tested as 78.03 96.26 and 86.19 respectively. The Accuracy of the system in evaluating a call is 70.

Time Trials--An AP Physics Challenge Lab

Science.gov (United States)

Jones, David

2009-01-01

I have come to the conclusion that for high school physics classroom and laboratory experiences, simpler is better! In this paper I describe a very simple and effective lab experience that my AP students have thoroughly enjoyed year after year. I call this lab exercise "Time Trials." The experiment is simple in design and it is a lot of fun for…

Protocol for a randomised controlled trial examining the impact of a web-based personally controlled health management system on the uptake of influenza vaccination rates

Directory of Open Access Journals (Sweden)

Lau Annie Y S

2012-04-01

Full Text Available Abstract Background Online social networking and personally controlled health management systems (PCHMS offer a new opportunity for developing innovative interventions to prevent diseases of public health concern (e.g., influenza but there are few comparative studies about patterns of use and impact of these systems. Methods/Design A 2010 CONSORT-compliant randomised controlled trial with a two-group parallel design will assess the efficacy of a web-based PCHMS called Healthy.me in facilitating the uptake of influenza vaccine amongst university students and staff. Eligible participants are randomised either to obtain access to Healthy.me or a 6-month waitlist. Participants complete pre-study, post-study and monthly surveys about their health and utilisation of health services. A post-study clinical audit will be conducted to validate self-reports about influenza vaccination and visits to the university health service due to influenza-like illness (ILI amongst a subset of participants. 600 participants older than 18 years with monthly access to the Internet and email will be recruited. Participants who (i discontinue the online registration process; (ii report obtaining an influenza vaccination in 2010 before the commencement of the study; or (iii report being influenced by other participants to undertake influenza vaccination will be excluded from analysis. The primary outcome measure is the number of participants obtaining influenza vaccination during the study. Secondary outcome measures include: number of participants (i experiencing ILI symptoms, (ii absent from or experiencing impairment in work or study due to ILI symptoms, (iii using health services or medications due to ILI symptoms; (iv expressing positive or negative attitudes or experiences towards influenza vaccination, via their reasons of receiving (or not receiving influenza vaccine; and (v their patterns of usage of Healthy.me (e.g., frequency and timing of hits, duration of

Calling in Work: Secular or Sacred?

Science.gov (United States)

Steger, Michael F.; Pickering, N. K.; Shin, J. Y.; Dik, B. J.

2010-01-01

Recent scholarship indicates that people who view their work as a calling are more satisfied with their work and their lives. Historically, calling has been regarded as a religious experience, although modern researchers frequently have adopted a more expansive and secular conceptualization of calling, emphasizing meaning and personal fulfillment…

Competing events and costs of clinical trials: Analysis of a randomized trial in prostate cancer

International Nuclear Information System (INIS)

Zakeri, Kaveh; Rose, Brent S.; D’Amico, Anthony V.; Jeong, Jong-Hyeon; Mell, Loren K.

2015-01-01

Background: Clinical trial costs may be reduced by identifying enriched subpopulations of patients with favorable risk profiles for the events of interest. However, increased selectivity affects accrual rates, with uncertain impact on clinical trial cost. Methods: We conducted a secondary analysis of Southwest Oncology Group (SWOG) 8794 randomized trial of adjuvant radiotherapy for high-risk prostate cancer. The primary endpoint was metastasis-free survival (MFS), defined as time to metastasis or death from any cause (competing mortality). We used competing risks regression models to identify an enriched subgroup at high risk for metastasis and low risk for competing mortality. We applied a cost model to estimate the impact of enrichment on trial cost and duration. Results: The treatment effect on metastasis was similar in the enriched subgroup (HR, 0.42; 95% CI, 0.23–0.76) compared to the whole cohort (HR, 0.50; 95% CI, 0.30–0.81) while the effect on competing mortality was not significant in the subgroup or the whole cohort (HR 0.70; 95% CI 0.39–1.23, vs. HR 0.94; 95% CI, 0.68–1.31). Due to the higher incidence of metastasis relative to competing mortality in the enriched subgroup, the treatment effect on MFS was greater in the subgroup compared to the whole cohort (HR 0.55; 95% CI 0.36–0.82, vs. HR 0.77; 95% CI, 0.58–1.01). Trial cost was 75% less in the subgroup compared to the whole cohort ($1.7 million vs. $6.8 million), and the trial duration was 30% shorter (8.4 vs. 12.0 years). Conclusion: Competing event enrichment can reduce clinical trial cost and duration, without sacrificing generalizability

Hornbills can distinguish between primate alarm calls.

Science.gov (United States)

Rainey, Hugo J.; Zuberbühler, Klaus; Slater, Peter J. B.

2004-01-01

Some mammals distinguish between and respond appropriately to the alarm calls of other mammal and bird species. However, the ability of birds to distinguish between mammal alarm calls has not been investigated. Diana monkeys (Cercopithecus diana) produce different alarm calls to two predators: crowned eagles (Stephanoaetus coronatus) and leopards (Panthera pardus). Yellow-casqued hornbills (Ceratogymna elata) are vulnerable to predation by crowned eagles but are not preyed on by leopards and might therefore be expected to respond to the Diana monkey eagle alarm call but not to the leopard alarm call. We compared responses of hornbills to playback of eagle shrieks, leopard growls, Diana monkey eagle alarm calls and Diana monkey leopard alarm calls and found that they distinguished appropriately between the two predator vocalizations as well as between the two Diana monkey alarm calls. We discuss possible mechanisms leading to these responses. PMID:15209110

Critique of the NOME law impact study

International Nuclear Information System (INIS)

Leveque, F.; Saguan, M.

2010-01-01

The authors propose a critical economic analysis of the impact study which goes with the bill on a New Organisation of the Electricity Market (NOME, for Nouvelle Organisation du Marche de l'Electricite). The first part summarises the prospective scenario used in the impact study, and proposes a more realistic scenario. Then they call into question an advantage which is presented as crucial in the impact study, i.e. a greater visibility of the regulation which would allow economic actors to take efficient long-term decisions. They discuss the upholding of the redistribution of the economic advantage of the past nuclear investment (the so-called 'nuclear guaranteed income') to consumers. The last part calls into question the investment realisation foreseen in the impact study

From nestling calls to fledgling silence: adaptive timing of change in response to aerial alarm calls.

Science.gov (United States)

Magrath, Robert D; Platzen, Dirk; Kondo, Junko

2006-09-22

Young birds and mammals are extremely vulnerable to predators and so should benefit from responding to parental alarm calls warning of danger. However, young often respond differently from adults. This difference may reflect: (i) an imperfect stage in the gradual development of adult behaviour or (ii) an adaptation to different vulnerability. Altricial birds provide an excellent model to test for adaptive changes with age in response to alarm calls, because fledglings are vulnerable to a different range of predators than nestlings. For example, a flying hawk is irrelevant to a nestling in a enclosed nest, but is dangerous to that individual once it has left the nest, so we predict that young develop a response to aerial alarm calls to coincide with fledging. Supporting our prediction, recently fledged white-browed scrubwrens, Sericornis frontalis, fell silent immediately after playback of their parents' aerial alarm call, whereas nestlings continued to calling despite hearing the playback. Young scrubwrens are therefore exquisitely adapted to the changing risks faced during development.

The evaluation of a standardized call/recall system for childhood immunizations in Wandsworth, England.

Science.gov (United States)

Atchison, Christina; Zvoc, Miro; Balakrishnan, Ravikumar

2013-06-01

To improve uptake of childhood immunizations in Wandsworth we developed a standardized call/recall system based on parents being sent three reminders and defaulters being referred to a Health Visitor. Thirty-two out of 44 primary care practices in the area implemented the intervention in September 2011. The aim of this study was to evaluate the implementation, delivery and impact on immunization uptake of the new call/recall system. To assess implementation and delivery, a mixed method approach was used including qualitative (structured interviews) and quantitative (data collected at three months post-implementation) assessment. To assess the impact, we used Student's t test to compare the difference in immunization uptake rates between intervention and non-intervention practices before and after implementation. The call/recall system was viewed positively by both parents and staff. Most children due or overdue immunizations were successfully captured by the 1st invitation reminder. After three invitations, between 87.3 % (MMR1) and 92.2 % (pre-school booster) of children identified as due or overdue immunizations successfully responded. Prior to implementation there was no difference in uptake rates between intervention and non-intervention practices. Post-implementation uptake rates for DTaP/IPV/Hib, MMR1, MMR2 and the pre-school booster were significantly greater in the intervention practices. Similar findings were seen for PCV and Hib/MenC boosters, although the differences were not statistically significant at the 5 % level. Following the successful implementation of a standardized call/recall system in Wandsworth, other regions or primary care practices may wish to consider introducing a similar system to help improve their immunization coverage levels.

Impact of Site Selection and Study Conduct on Outcomes in Global Clinical Trials.

Science.gov (United States)

Sarwar, Chaudhry M S; Vaduganathan, Muthiah; Butler, Javed

2017-08-01

There are over 25 million patients living with heart failure globally. Overall, and especially post-discharge, clinical outcomes have remained poor in heart failure despite multiple trials, with both successes and failures over the last two decades. Matching therapies to the right patient population, identifying high-quality sites, and ensuring optimal trial design and execution represent important considerations in the development of novel therapeutics in this space. While clinical trials have undergone rapid globalization, this has come with regional variation in comorbidities, clinical parameters, and even clinical outcomes and treatment effects across international sites. These issues have now highlighted knowledge gaps about the conduct of trials, selection of study sites, and an unmet need to develop and identify "ideal" sites. There is a need for all stakeholders, including academia, investigators, healthcare organizations, patient advocacy groups, industry sponsors, research organizations, and regulatory authorities, to work as a multidisciplinary group to address these problems and develop practical solutions to improve trial conduct, efficiency, and execution. We review these trial-level issues using examples from contemporary studies to inform and optimize the design of future global clinical trials in heart failure.

Protecting intellectual property associated with Canadian academic clinical trials - approaches and impact

Directory of Open Access Journals (Sweden)

Ross Sue

2012-12-01

Full Text Available Abstract Intellectual property is associated with the creative work needed to design clinical trials. Two approaches have developed to protect the intellectual property associated with multicentre trial protocols prior to site initiation. The ‘open access’ approach involves publishing the protocol, permitting easy access to the complete protocol. The main advantages of the open access approach are that the protocol is freely available to all stakeholders, permitting them to discuss the protocol widely with colleagues, assess the quality and rigour of the protocol, determine the feasibility of conducting the trial at their centre, and after trial completion, to evaluate the reported findings based on a full understanding of the protocol. The main potential disadvantage of this approach is the potential for plagiarism; however if that occurred, it should be easy to identify because of the open access to the original trial protocol, as well as ensure that appropriate sanctions are used to deal with plagiarism. The ‘restricted access’ approach involves the use of non-disclosure agreements, legal documents that must be signed between the trial lead centre and collaborative sites. Potential sites must guarantee they will not disclose any details of the study before they are permitted to access the protocol. The main advantages of the restricted access approach are for the lead institution and nominated principal investigator, who protect their intellectual property associated with the trial. The main disadvantages are that ownership of the protocol and intellectual property is assigned to the lead institution; defining who ‘needs to know’ about the study protocol is difficult; and the use of non-disclosure agreements involves review by lawyers and institutional representatives at each site before access is permitted to the protocol, significantly delaying study implementation and adding substantial indirect costs to research institutes

Protecting intellectual property associated with Canadian academic clinical trials--approaches and impact.

Science.gov (United States)

Ross, Sue; Magee, Laura; Walker, Mark; Wood, Stephen

2012-12-27

Intellectual property is associated with the creative work needed to design clinical trials. Two approaches have developed to protect the intellectual property associated with multicentre trial protocols prior to site initiation. The 'open access' approach involves publishing the protocol, permitting easy access to the complete protocol. The main advantages of the open access approach are that the protocol is freely available to all stakeholders, permitting them to discuss the protocol widely with colleagues, assess the quality and rigour of the protocol, determine the feasibility of conducting the trial at their centre, and after trial completion, to evaluate the reported findings based on a full understanding of the protocol. The main potential disadvantage of this approach is the potential for plagiarism; however if that occurred, it should be easy to identify because of the open access to the original trial protocol, as well as ensure that appropriate sanctions are used to deal with plagiarism. The 'restricted access' approach involves the use of non-disclosure agreements, legal documents that must be signed between the trial lead centre and collaborative sites. Potential sites must guarantee they will not disclose any details of the study before they are permitted to access the protocol. The main advantages of the restricted access approach are for the lead institution and nominated principal investigator, who protect their intellectual property associated with the trial. The main disadvantages are that ownership of the protocol and intellectual property is assigned to the lead institution; defining who 'needs to know' about the study protocol is difficult; and the use of non-disclosure agreements involves review by lawyers and institutional representatives at each site before access is permitted to the protocol, significantly delaying study implementation and adding substantial indirect costs to research institutes. This extra step may discourage sites from

A randomized trial assessing the impact of written information on outpatients' knowledge about and attitude toward randomized clinical trials. The Info Trial Group

DEFF Research Database (Denmark)

Kruse, A Y; Kjaergard, L L; Krogsgaard, K

2000-01-01

To improve the patient education process in clinical research, three information materials describing general aspects of design and conduct of randomized clinical trials were developed. The materials varied in length, reading ability level, and reader appeal. Their influence on knowledge about...... and attitude toward randomized clinical trials was assessed in a randomized, parallel group, evaluator-blinded trial among 415 outpatients. The patients were randomized to the following groups: control (no intervention), leaflet, brochure, or booklet. Knowledge was assessed by a 17-item multiple......-choice questionnaire and attitude was assessed by a 32-item Likert questionnaire at entry and 2 weeks after the intervention. The interventions and the questionnaires were pilot tested and power calculations were performed. At entry, the mean knowledge score was 7.9 points. At follow-up, the knowledge scores increased...

The potential impact of recruitment method on sample characteristics and treatment outcomes in a psychosocial trial for women with co-occurring substance use disorder and PTSD.

Science.gov (United States)

Winhusen, Theresa; Winstanley, Erin L; Somoza, Eugene; Brigham, Gregory

2012-01-01

Recruitment method can impact the sample composition of a clinical trial and, thus, the generalizability of the results, but the importance of recruitment method in substance use disorder trials has received little attention. The present paper sought to address this research gap by evaluating the association between recruitment method and sample characteristics and treatment outcomes in a substance use disorder trial. In a multi-site trial evaluating Seeking Safety (SS), relative to Women's Health Education (WHE), for women with co-occurring PTSD (either sub-threshold or full PTSD) and substance use disorders, one site assessed the method by which each participant was recruited. Data from this site (n=106), which recruited participants from newspaper advertising and clinic intakes, were analyzed. Participants recruited through advertising, relative to those from the clinic, had significantly higher levels of baseline drug use and higher rates of meeting DSM-IV-TR criteria for full PTSD. Results suggest that the effectiveness of SS in decreasing PTSD symptoms was greater for participants recruited through advertising relative to those recruited from the clinic. Conversely, the results revealed a significant treatment effect in the clinic-recruited participants, not seen in the advertising-recruited participants, with SS, relative to WHE, participants being more likely to report past week drug use during the follow-up phase. Recruitment method may impact sample composition and treatment effects. Replication of this finding would have important implications for substance use disorder efficacy trials which often utilize advertising to recruit participants. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

The Impact of Short-Term Video Games on Performance among Children with Developmental Delays: A Randomized Controlled Trial

Science.gov (United States)

Hsieh, Ru-Lan; Lee, Wen-Chung; Lin, Jui-Hsiang

2016-01-01

This prospective, randomized controlled study investigated the effects of short-term interactive video game playing among children with developmental delays participating in traditional rehabilitation treatment at a rehabilitation clinic. One hundred and one boys and 46 girls with a mean age of 5.8 years (range: 3 to 12 years) were enrolled in this study. All patients were confirmed to suffer from developmental delays, and were participating in traditional rehabilitation treatment. Children participated in two periods of 4 weeks each, group A being offered intervention of eight 30-minute sessions of interactive video games in the first period, and group B in the second, in addition to the traditional rehabilitation treatment. The physical, psychosocial, and total health of the children was periodically assessed using the parent-reported Pediatric Quality of Life Inventory-Generic Core Scales (PedsQL); and the children’s upper extremity and physical function, transfer and basic mobility, sports and physical functioning, and global functioning were assessed using the Pediatric Outcomes Data Collection Instrument. Parental impact was evaluated using the PedsQL-Family Impact Module for family function, PedsQL-Health Satisfaction questionnaire for parents’ satisfaction with their children’s care and World Health Organization-Quality of Life-Brief Version for quality of life. Compared with the baseline, significant improvements of physical function were observed in both groups (5.6 ± 19.5, p = 0.013; 4.7 ± 13.8, p = 0.009) during the intervention periods. No significant improvement of psychosocial health, functional performance, or family impact was observed in children with developmental delays. Short-term interactive video game play in conjunction with traditional rehabilitation treatment improved the physical health of children with developmental delays. Trial Registration: ClinicalTrials.gov NCT02184715 PMID:26983099

Stressful Demands or Helpful Guidance? The Role of Display Rules in Indian Call Centers

Science.gov (United States)

Little, Laura M.; Nelson, Debra L.; Quade, Matthew J.; Ward, Andrew

2011-01-01

This paper utilizes conservation of resources (COR) theory and two of Hofstede's (1980) dimensions of culture (individualism and power distance) to examine the impact of display rules on job satisfaction and performance in an Indian call center sample. Contrary to findings in an American sample (Wilk & Moynihan, 2005), we proposed that due to…

The impact of clinical trial monitoring approaches on data integrity and cost--a review of current literature.

Science.gov (United States)

Olsen, Rasmus; Bihlet, Asger Reinstrup; Kalakou, Faidra; Andersen, Jeppe Ragnar

2016-04-01

Monitoring is a costly requirement when conducting clinical trials. New regulatory guidance encourages the industry to consider alternative monitoring methods to the traditional 100 % source data verification (SDV) approach. The purpose of this literature review is to provide an overview of publications on different monitoring methods and their impact on subject safety data, data integrity, and monitoring cost. The literature search was performed by keyword searches in MEDLINE and hand search of key journals. All publications were reviewed for details on how a monitoring approach impacted subject safety data, data integrity, or monitoring costs. Twenty-two publications were identified. Three publications showed that SDV has some value for detection of not initially reported adverse events and centralized statistical monitoring (CSM) captures atypical trends. Fourteen publications showed little objective evidence of improved data integrity with traditional monitoring such as 100 % SDV and sponsor queries as compared to reduced SDV, CSM, and remote monitoring. Eight publications proposed a potential for significant cost reductions of monitoring by reducing SDV without compromising the validity of the trial results. One hundred percent SDV is not a rational method of ensuring data integrity and subject safety based on the high cost, and this literature review indicates that reduced SDV is a viable monitoring method. Alternative methods of monitoring such as centralized monitoring utilizing statistical tests are promising alternatives but have limitations as stand-alone tools. Reduced SDV combined with a centralized, risk-based approach may be the ideal solution to reduce monitoring costs while improving essential data quality.

Peafowl antipredator calls encode information about signalers.

Science.gov (United States)

Yorzinski, Jessica L

2014-02-01

Animals emit vocalizations that convey information about external events. Many of these vocalizations, including those emitted in response to predators, also encode information about the individual that produced the call. The relationship between acoustic features of antipredator calls and information relating to signalers (including sex, identity, body size, and social rank) were examined in peafowl (Pavo cristatus). The "bu-girk" antipredator calls of male and female peafowl were recorded and 20 acoustic parameters were automatically extracted from each call. Both the bu and girk elements of the antipredator call were individually distinctive and calls were classified to the correct signaler with over 90% and 70% accuracy in females and males, respectively. Females produced calls with a higher fundamental frequency (F0) than males. In both females and males, body size was negatively correlated with F0. In addition, peahen rank was related to the duration, end mean frequency, and start harmonicity of the bu element. Peafowl antipredator calls contain detailed information about the signaler and can potentially be used by receivers to respond to dangerous situations.

Cluster randomized trial to evaluate the impact of team training on surgical outcomes.

Science.gov (United States)

Duclos, A; Peix, J L; Piriou, V; Occelli, P; Denis, A; Bourdy, S; Carty, M J; Gawande, A A; Debouck, F; Vacca, C; Lifante, J C; Colin, C

2016-12-01

The application of safety principles from the aviation industry to the operating room has offered hope in reducing surgical complications. This study aimed to assess the impact on major surgical complications of adding an aviation-based team training programme after checklist implementation. A prospective parallel-group cluster trial was undertaken between September 2011 and March 2013. Operating room teams from 31 hospitals were assigned randomly to participate in a team training programme focused on major concepts of crew resource management and checklist utilization. The primary outcome measure was the occurrence of any major adverse event, including death, during the hospital stay within the first 30 days after surgery. Using a difference-in-difference approach, the ratio of the odds ratios (ROR) was estimated to compare changes in surgical outcomes between intervention and control hospitals. Some 22 779 patients were enrolled, including 5934 before and 16 845 after team training implementation. The risk of major adverse events fell from 8·8 to 5·5 per cent in 16 intervention hospitals (adjusted odds ratio 0·57, 95 per cent c.i. 0·48 to 0·68; P trends revealed significant improvements among ten institutions, equally distributed across intervention and control hospitals. Surgical outcomes improved substantially, with no difference between trial arms. Successful implementation of an aviation-based team training programme appears to require modification and adaptation of its principles in the context of the the surgical milieu. Registration number: NCT01384474 (http://www.clinicaltrials.gov). © 2016 BJS Society Ltd Published by John Wiley & Sons Ltd.

Anticholinergic versus botulinum toxin A comparison trial for the treatment of bothersome urge urinary incontinence: ABC trial.

Science.gov (United States)

Visco, Anthony G; Brubaker, Linda; Richter, Holly E; Nygaard, Ingrid; Paraiso, Marie Fidela; Menefee, Shawn A; Schaffer, Joseph; Wei, John; Chai, Toby; Janz, Nancy; Spino, Cathie; Meikle, Susan

2012-01-01

This trial compares the change in urgency urinary incontinence episodes over 6 months, tolerability and cost effectiveness between women receiving daily anticholinergic therapy plus a single intra-detrusor injection of saline versus a single intra-detrusor injection of 100 U of botulinum toxin A plus daily oral placebo tablets. We present the rationale and design of a randomized-controlled trial, Anticholinergic versus Botulinum Toxin, Comparison Trial for the Treatment of Bothersome Urge Urinary Incontinence: ABC trial, conducted by the NICHD-funded Pelvic Floor Disorders Network. We discuss the innovative nature of this trial and the challenges related to choice of patient population, maintaining masking, cost effectiveness, ethical considerations, measuring adherence, and placebo development and testing. Enrollment began in April, 2010. 242 participants will be randomized and primary outcome data analysis is anticipated to begin in mid 2012. Several challenges in the trial design are discussed. Randomization to placebo intra-detrusor injections may limit recruitment, potentially impacting generalizability. Other challenges included the heavy marketing of drugs for overactive bladder which could impact recruitment of drug-naïve women. In addition, anticholinergic medications often cause dry mouth, making masking difficult. Finally, adverse reporting of transient urinary retention is challenging as there is no standardized definition; yet this is the most common adverse event following intra-detrusor botulinum toxin injection. The ABC trial will help women with urgency urinary incontinence balance efficacy, side effects and cost of anticholinergic medication versus botulinum toxin intra-detrusor injection. The results have the potential to fundamentally change the therapeutic approach to this condition. Copyright © 2011 Elsevier Inc. All rights reserved.

BUFO PARDALIS (ANURA: BUFONIDAE): MATING CALL AND ...

African Journals Online (AJOL)

the calls of one of these species, Bufo pardalis. Hewitt, were not analysed by Tandy & Keith. (1972). Furthennore there is some confusion in the literature regarding the mating call of this species. For these reasons this mating call is here clarified. The mating call of B. pardaiis was first described by Ranger (in Hewitt 1935) as ...

Impact of intermittent screening and treatment for malaria among school children in Kenya: a cluster randomised trial.

Directory of Open Access Journals (Sweden)

Katherine E Halliday

2014-01-01

Full Text Available Improving the health of school-aged children can yield substantial benefits for cognitive development and educational achievement. However, there is limited experimental evidence of the benefits of alternative school-based malaria interventions or how the impacts of interventions vary according to intensity of malaria transmission. We investigated the effect of intermittent screening and treatment (IST for malaria on the health and education of school children in an area of low to moderate malaria transmission.A cluster randomised trial was implemented with 5,233 children in 101 government primary schools on the south coast of Kenya in 2010-2012. The intervention was delivered to children randomly selected from classes 1 and 5 who were followed up for 24 months. Once a school term, children were screened by public health workers using malaria rapid diagnostic tests (RDTs, and children (with or without malaria symptoms found to be RDT-positive were treated with a six dose regimen of artemether-lumefantrine (AL. Given the nature of the intervention, the trial was not blinded. The primary outcomes were anaemia and sustained attention. Secondary outcomes were malaria parasitaemia and educational achievement. Data were analysed on an intention-to-treat basis. During the intervention period, an average of 88.3% children in intervention schools were screened at each round, of whom 17.5% were RDT-positive. 80.3% of children in the control and 80.2% in the intervention group were followed-up at 24 months. No impact of the malaria IST intervention was observed for prevalence of anaemia at either 12 or 24 months (adjusted risk ratio [Adj.RR]: 1.03, 95% CI 0.93-1.13, p = 0.621 and Adj.RR: 1.00, 95% CI 0.90-1.11, p = 0.953 respectively, or on prevalence of P. falciparum infection or scores of classroom attention. No effect of IST was observed on educational achievement in the older class, but an apparent negative effect was seen on spelling scores in

External GSM phone calls now made simpler

CERN Multimedia

2007-01-01

On 2 July, the IT/CS Telecom Service introduced a new service making external calls from CERN GSM phones easier. A specific prefix is no longer needed for calls outside CERN. External calls from CERN GSM phones are to be simplified. It is no longer necessary to use a special prefix to call an external number from the CERN GSM network.The Telecom Section of the IT/CS Group is introducing a new system that will make life easier for GSM users. It is no longer necessary to use a special prefix (333) to call an external number from the CERN GSM network. Simply dial the number directly like any other Swiss GSM customer. CERN currently has its own private GSM network with the Swiss mobile operator, Sunrise, covering the whole of Switzerland. This network was initially intended exclusively for calls between CERN numbers (replacing the old beeper system). A special system was later introduced for external calls, allowing them to pass thr...

Sharing programming resources between Bio* projects through remote procedure call and native call stack strategies.

Science.gov (United States)

Prins, Pjotr; Goto, Naohisa; Yates, Andrew; Gautier, Laurent; Willis, Scooter; Fields, Christopher; Katayama, Toshiaki

2012-01-01

Open-source software (OSS) encourages computer programmers to reuse software components written by others. In evolutionary bioinformatics, OSS comes in a broad range of programming languages, including C/C++, Perl, Python, Ruby, Java, and R. To avoid writing the same functionality multiple times for different languages, it is possible to share components by bridging computer languages and Bio* projects, such as BioPerl, Biopython, BioRuby, BioJava, and R/Bioconductor. In this chapter, we compare the two principal approaches for sharing software between different programming languages: either by remote procedure call (RPC) or by sharing a local call stack. RPC provides a language-independent protocol over a network interface; examples are RSOAP and Rserve. The local call stack provides a between-language mapping not over the network interface, but directly in computer memory; examples are R bindings, RPy, and languages sharing the Java Virtual Machine stack. This functionality provides strategies for sharing of software between Bio* projects, which can be exploited more often. Here, we present cross-language examples for sequence translation, and measure throughput of the different options. We compare calling into R through native R, RSOAP, Rserve, and RPy interfaces, with the performance of native BioPerl, Biopython, BioJava, and BioRuby implementations, and with call stack bindings to BioJava and the European Molecular Biology Open Software Suite. In general, call stack approaches outperform native Bio* implementations and these, in turn, outperform RPC-based approaches. To test and compare strategies, we provide a downloadable BioNode image with all examples, tools, and libraries included. The BioNode image can be run on VirtualBox-supported operating systems, including Windows, OSX, and Linux.

Call Duration Characteristics based on Customers Location

Directory of Open Access Journals (Sweden)

Žvinys Karolis

2014-05-01

Full Text Available Nowadays a lot of different researches are performed based on call duration distributions (CDD analysis. However, the majority of studies are linked with social relationships between the people. Therefore the scarcity of information, how the call duration is associated with a user's location, is appreciable. The goal of this paper is to reveal the ties between user's voice call duration and the location of call. For this reason we analyzed more than 5 million calls from real mobile network, which were made over the base stations located in rural areas, roads, small towns, business and entertainment centers, residential districts. According to these site types CDD’s and characteristic features for call durations are given and discussed. Submitted analysis presents the users habits and behavior as a group (not an individual. The research showed that CDD’s of customers being them in different locations are not equal. It has been found that users at entertainment, business centers are tend to talk much shortly, than people being at home. Even more CDD can be distorted strongly, when machinery calls are evaluated. Hence to apply a common CDD for a whole network it is not recommended. The study also deals with specific parameters of call duration for distinguished user groups, the influence of network technology for call duration is considered.

Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative.

Science.gov (United States)

Huang, Grant D; Bull, Jonca; Johnston McKee, Kelly; Mahon, Elizabeth; Harper, Beth; Roberts, Jamie N

2018-03-01

Patient recruitment is widely recognized as a key determinant of success for clinical trials. Yet a substantial number of trials fail to reach recruitment goals-a situation that has important scientific, financial, ethical, and policy implications. Further, there are important effects on stakeholders who directly contribute to the trial including investigators, sponsors, and study participants. Despite efforts over multiple decades to identify and address barriers, recruitment challenges persist. To advance a more comprehensive approach to trial recruitment, the Clinical Trials Transformation Initiative (CTTI) convened a project team to examine the challenges and to issue actionable, evidence-based recommendations for improving recruitment planning that extend beyond common study-specific strategies. We describe our multi-stakeholder effort to develop a framework that delineates three areas essential to strategic recruitment planning efforts: (1) trial design and protocol development, (2) trial feasibility and site selection, and (3) communication. Our recommendations propose an upstream approach to recruitment planning that has the potential to produce greater impact and reduce downstream barriers. Additionally, we offer tools to help facilitate adoption of the recommendations. We hope that our framework and recommendations will serve as a guide for initial efforts in clinical trial recruitment planning irrespective of disease or intervention focus, provide a common basis for discussions in this area and generate targets for further analysis and continual improvement. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

The impact of comorbid body dysmorphic disorder on the response to sequential pharmacological trials for obsessive-compulsive disorder.

Science.gov (United States)

Diniz, Juliana B; Costa, Daniel Lc; Cassab, Raony Cc; Pereira, Carlos Ab; Miguel, Euripedes C; Shavitt, Roseli G

2014-06-01

Our aim was to investigate the impact of comorbid body dysmorphic disorder (BDD) on the response to sequential pharmacological trials in adult obsessive-compulsive disorder (OCD) patients. The sequential trial initially involved fluoxetine monotherapy followed by one of three randomized, add-on strategies: placebo, clomipramine or quetiapine. We included 138 patients in the initial phase of fluoxetine, up to 80 mg or the maximum tolerated dosage, for 12 weeks. We invited 70 non-responders to participate in the add-on trial; as 54 accepted, we allocated 18 to each treatment group and followed them for an additional 12 weeks. To evaluate the combined effects of sex, age, age at onset, initial severity, type of augmentation and BDD on the response to sequential treatments, we constructed a model using generalized estimating equations (GEE). Of the 39 patients who completed the study (OCD-BDD, n = 13; OCD-non-BDD, n = 26), the OCD-BDD patients were less likely to be classified as responders than the OCD-non-BDD patients (Pearson Chi-Square = 4.4; p = 0.036). In the GEE model, BDD was not significantly associated with a worse response to sequential treatments (z-robust = 1.77; p = 0.07). The predictive potential of BDD regarding sequential treatment strategies for OCD did not survive when the analyses were controlled for other clinical characteristics. © The Author(s) 2013.

Changing cluster composition in cluster randomised controlled trials: design and analysis considerations

Science.gov (United States)

2014-01-01

Background There are many methodological challenges in the conduct and analysis of cluster randomised controlled trials, but one that has received little attention is that of post-randomisation changes to cluster composition. To illustrate this, we focus on the issue of cluster merging, considering the impact on the design, analysis and interpretation of trial outcomes. Methods We explored the effects of merging clusters on study power using standard methods of power calculation. We assessed the potential impacts on study findings of both homogeneous cluster merges (involving clusters randomised to the same arm of a trial) and heterogeneous merges (involving clusters randomised to different arms of a trial) by simulation. To determine the impact on bias and precision of treatment effect estimates, we applied standard methods of analysis to different populations under analysis. Results Cluster merging produced a systematic reduction in study power. This effect depended on the number of merges and was most pronounced when variability in cluster size was at its greatest. Simulations demonstrate that the impact on analysis was minimal when cluster merges were homogeneous, with impact on study power being balanced by a change in observed intracluster correlation coefficient (ICC). We found a decrease in study power when cluster merges were heterogeneous, and the estimate of treatment effect was attenuated. Conclusions Examples of cluster merges found in previously published reports of cluster randomised trials were typically homogeneous rather than heterogeneous. Simulations demonstrated that trial findings in such cases would be unbiased. However, simulations also showed that any heterogeneous cluster merges would introduce bias that would be hard to quantify, as well as having negative impacts on the precision of estimates obtained. Further methodological development is warranted to better determine how to analyse such trials appropriately. Interim recommendations

Recruiting Unmotivated Smokers into a Smoking Induction Trial

Science.gov (United States)

Harris, Kari Jo; Bradley-Ewing, Andrea; Goggin, Kathy; Richter, Kimber P.; Patten, Christi; Williams, Karen; Lee, Hyoung S.; Staggs, Vincent S.; Catley, Delwyn

2016-01-01

Little is known about effective methods to recruit unmotivated smokers into cessation induction trials, the reasons unmotivated smokers agree to participate, and the impact of those reasons on study outcomes. A mixed-method approach was used to examine recruitment data from a randomized controlled cessation induction trial that enrolled 255 adult…

Does the increasing placebo response impact outcomes of adult and pediatric ADHD clinical trials? Data from the US Food and Drug Administration 2000-2009.

Science.gov (United States)

Khan, Arif; Fahl Mar, Kaysee; Brown, Walter A

2017-11-01

In a study of recent antidepressant clinical trial data, it was found placebo response had grown significantly over time and that contrary to expectations, trial outcome measures and success rate were not impacted. The aim of this paper was to evaluate if this trend of increasing placebo response and stable outcome measures could be seen in clinical trial data for Attention-Deficit Hyperactivity Disorder, a different psychiatric condition with susceptibility to placebo response. For this reason, we evaluated efficacy data reported in the FDA Medical and Statistical reviews for 10 ADHD medication programs (4917 patients, 17 trials, 29 treatment arms). Placebo and medication response were measured as percent symptom reduction and effect sizes and drug-placebo differences were calculated for each treatment arm and analyzed in relation to year of approval. We also investigated the potential role of age and medication class on trends and outcomes. Results showed a similar pattern to antidepressants wherein the placebo response is rising significantly over time (r = 0.636, p = 0.006) and effect size (r stimulants were found to have more robust treatment effects than adult trials and non-stimulants. The results of this study suggest that like antidepressants, the relationship between placebo response and the outcomes of ADHD clinical trials is weak at best. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Long-term impact of endometrial cancer diagnosis and treatment on health-related quality of life and cancer survivorship : Results from the randomized PORTEC-2 trial

NARCIS (Netherlands)

De Boer, Stephanie M.; Nout, Remi A.; Jurgenliemk-Schulz, Ina M.; Jobsen, Jan J; Lutgens, Ludy C.H.W.; Van Der Steen-Banasik, Elzbieta M.; Mens, Jan Willem M.; Slot, Annerie; Stenfert Kroese, Marika C.; Oerlemans, Simone; Putter, Hein; Verhoeven-Adema, Karen W.; Nijman, Hans W; Creutzberg, Carien L.

2015-01-01

Purpose: To evaluate the long-term health-related quality of life (HRQL) after external beam radiation therapy (EBRT) or vaginal brachytherapy (VBT) among PORTEC-2 trial patients, evaluate long-term bowel and bladder symptoms, and assess the impact of cancer on these endometrial cancer (EC)

Long-term impact of endometrial cancer diagnosis and treatment on health-related quality of life and cancer survivorship : Results from the randomized PORTEC-2 trial

NARCIS (Netherlands)

de Boer, Stephanie M.; Nout, Remi A.; Jurgenliemk-Schulz, Ina M.; Jobsen, Jan J.; Lutgens, Ludy C. H. W.; van der Steen-Banasik, Elzbieta M.; Mens, Jan Willem M.; Slot, Annerie; Kroese, Marika C. Stenfert; Oerlemans, Simone; Putter, Hein; Verhoeven-Adema, Karen W.; Nijman, Hans W.; Creutzberg, Carien L.

2015-01-01

Purpose To evaluate the long-term health-related quality of life (HRQL) after external beam radiation therapy (EBRT) or vaginal brachytherapy (VBT) among PORTEC-2 trial patients, evaluate long-term bowel and bladder symptoms, and assess the impact of cancer on these endometrial cancer (EC)

Long-Term Impact of Endometrial Cancer Diagnosis and Treatment on Health-Related Quality of Life and Cancer Survivorship : Results From the Randomized PORTEC-2 Trial

NARCIS (Netherlands)

de Boer, Stephanie M.; Nout, Remi A.; Jurgenliemk-Schulz, Ina M.; Jobsen, Jan J.; Lutgens, Ludy C. H. W.; van der Steen-Banasik, Elzbieta M.; Mens, Jan Willem M.; Slot, Annerie; Kroese, Marika C. Stenfert; Oerlemans, Simone; Putter, Hein; Verhoeven-Adema, Karen W.; Nijman, Hans W.; Creutzberg, Carien L.

2015-01-01

Purpose: To evaluate the long-term health-related quality of life (HRQL) after external beam radiation therapy (EBRT) or vaginal brachytherapy (VBT) among PORTEC-2 trial patients, evaluate long-term bowel and bladder symptoms, and assess the impact of cancer on these endometrial cancer (EC)

Accurate recapture identification for genetic mark–recapture studies with error-tolerant likelihood-based match calling and sample clustering

Science.gov (United States)

Sethi, Suresh; Linden, Daniel; Wenburg, John; Lewis, Cara; Lemons, Patrick R.; Fuller, Angela K.; Hare, Matthew P.

2016-01-01

Error-tolerant likelihood-based match calling presents a promising technique to accurately identify recapture events in genetic mark–recapture studies by combining probabilities of latent genotypes and probabilities of observed genotypes, which may contain genotyping errors. Combined with clustering algorithms to group samples into sets of recaptures based upon pairwise match calls, these tools can be used to reconstruct accurate capture histories for mark–recapture modelling. Here, we assess the performance of a recently introduced error-tolerant likelihood-based match-calling model and sample clustering algorithm for genetic mark–recapture studies. We assessed both biallelic (i.e. single nucleotide polymorphisms; SNP) and multiallelic (i.e. microsatellite; MSAT) markers using a combination of simulation analyses and case study data on Pacific walrus (Odobenus rosmarus divergens) and fishers (Pekania pennanti). A novel two-stage clustering approach is demonstrated for genetic mark–recapture applications. First, repeat captures within a sampling occasion are identified. Subsequently, recaptures across sampling occasions are identified. The likelihood-based matching protocol performed well in simulation trials, demonstrating utility for use in a wide range of genetic mark–recapture studies. Moderately sized SNP (64+) and MSAT (10–15) panels produced accurate match calls for recaptures and accurate non-match calls for samples from closely related individuals in the face of low to moderate genotyping error. Furthermore, matching performance remained stable or increased as the number of genetic markers increased, genotyping error notwithstanding.

Informed consent in surgical trials.

Science.gov (United States)

Etchells, E

1999-12-01

All participants must provide a valid consent to surgical clinical trials. A valid consent requires patient capacity, adequate disclosure of information, and voluntariness. Capacity is the ability to understand information relevant to making a decision and to appreciate the reasonably foreseeable consequences of a decision or lack of decision. To protect vulnerable persons, an incapable person should not be enrolled in most clinical trials. The only exception is if the study can only be conducted on incapable persons. If the willing research participant is incapable, consent must be obtained from others through a process called substitute (or proxy) consent. Disclosure refers to the provision of relevant information to the patient and its comprehension by the patient. Most surgical trials carry more than minimal risks, so the requirement for careful disclosure of these risks to potential participants is generally stringent. Voluntariness refers to the freedom of a person to make a treatment decision. In specific circumstances related to emergency research, the requirement for consent may be waived. Waiver can be justified only if the delay required to obtain consent would prevent the research from occurring and only after prior consultation with from the "community" of potential research participants.

Impact of 4.0% chlorhexidine cleansing of the umbilical cord on mortality and omphalitis among newborns of Sylhet, Bangladesh: design of a community-based cluster randomized trial

Directory of Open Access Journals (Sweden)

Ahmed Saifuddin

2009-10-01

Full Text Available Abstract Background The World Health Organization recommends dry cord care for newborns but this recommendation may not be optimal in low resource settings where most births take place in an unclean environment and infections account for up to half of neonatal deaths. A previous trial in Nepal indicated that umbilical cord cleansing with 4.0% chlorhexidine could substantially reduce mortality and omphalitis risk, but policy changes await additional community-based data. Methods The Projahnmo Chlorhexidine study was a three-year, cluster-randomized, community-based trial to assess the impact of three cord care regimens on neonatal mortality and omphalitis. Women were recruited mid-pregnancy, received a basic package of maternal and neonatal health promotion messages, and were followed to pregnancy outcome. Newborns were visited at home by local village-based workers whose areas were randomized to either 1 single- or 2 7-day cord cleansing with 4.0% chlorhexidine, or 3 promotion of dry cord care as recommended by WHO. All mothers received basic messages regarding hand-washing, clean cord cutting, and avoidance of harmful home-base applications to the cord. Death within 28 days and omphalitis were the primary outcomes; these were monitored directly through home visits by community health workers on days 1, 3, 6, 9, 15, and 28 after birth. Discussion Due to report in early 2010, the Projahnmo Chlorhexidine Study examines the impact of multiple or single chlorhexidine cleansing of the cord on neonatal mortality and omphalitis among newborns of rural Sylhet District, Bangladesh. The results of this trial will be interpreted in conjunction with a similarly designed trial previously conducted in Nepal, and will have implications for policy guidelines for optimal cord care of newborns in low resource settings in Asia. Trial Registration ClinicalTrials.gov (NCT00434408

Recognizing False Biochemical Failure Calls After Radiation With or Without Neo-Adjuvant Androgen Deprivation for Prostate Cancer

International Nuclear Information System (INIS)

Denham, James W.; Kumar, Mahesh; Gleeson, Paul S.; Lamb, David S.; Joseph, David FRANZCR.; Atkinson, Chris FRANZCR.; Matthews, John FRANZCR.; Tai, K.-H.; Spry, Nigel A.; Christie, David; Turner, Sandra FRANZCR.; Greer, Peter B.; D'Este, Catherine; Steigler, Allison

2009-01-01

Purpose: We studied prostate-specific antigen (PSA) changes after radiation with or without neoadjuvant androgen deprivation to determine posttreatment PSA scenarios in which false-positive biochemical failures (FPBF) are most likely to occur. Methods and Materials: In the Trans-Tasman Radiation Oncology 96.01 Group trial, patients with T2b, 2c, 3, 4 N0 prostate cancer were randomized to 3 or 6 months goserelin and flutamide (STAD) before and during 66 Gy to the prostate and seminal vesicles (XRT) or to XRT alone. Piecewise longitudinal changes in PSA before relapse were characterized and quantified to determine which might cause FPBF calls. Results: Between 1996 and 2000, 802 eligible patients were randomized. Of these, 492 met the criteria for American Society for Therapeutic Radiology and Oncology (ASTRO) failure and 467 for Phoenix failure. Seventy-seven ASTRO fails and 39 Phoenix fails were deemed false positives (FPs). The majority of FPBFs were associated with the 'plateauing' in PSA values that follow posttreatment nadir. FPBFs were particularly common in men treated with STAD, in whom small, consecutive PSA rises before or during this phenomenon triggered 56 FP ASTRO fail calls. In these men, the Phoenix fail criteria triggered only 15 FPBF calls. However, the Phoenix criteria were more vulnerable than ASTRO to short-term isolated PSA rises during plateau, which resulted in 15 Phoenix fail calls but only 3 FP ASTRO fails. Conclusions: The Phoenix definition avoided 50% of FPBF calls that occurred with the ASTRO definition. Failures should be confirmed by further PSA rises before investigation and treatment is considered.

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)

Care and Calls

DEFF Research Database (Denmark)

Paasch, Bettina Sletten

on the enactment of care but also on patient safety. Nurses working in various hospital departments have developed different strategies for handling mobile phone calls when with a patient. Additional research into the ways nurses successfully or unsuccessfully enact care and ensure patient safety when they answer......In Danish hospitals, nurses have been equipped with a mobile work phone to improve their availability and efficiency. On the phones nurses receive internal and external phone conversations, patient calls, and alarms from electronic surveillance equipment. For safety reasons the phones cannot...... be switched off or silenced; they consequently ring during all activities and also during interactions with patients. A possible tension thus arises when nurses have to be both caring and sensitive towards the patient and simultaneously be efficient and available and answer their phone. The present paper...

Do market participants learn from conference calls?

NARCIS (Netherlands)

Roelofsen, E.; Verbeeten, F.; Mertens, G.

2014-01-01

We examine whether market participants learn from the information that is disseminated during the Q-and-A section of conference calls. Specifically, we investigate whether stock prices react to information on intangible assets provided during conference calls, and whether conference calls

The CYTONOX trial

DEFF Research Database (Denmark)

Gade, Christina; Mikus, Gerd; Christensen, Hanne Rolighed

2016-01-01

INTRODUCTION: In Denmark, it is estimated that 3-5% of children are obese. Obesity is associated with pathophysiological alterations that may lead to alterations in the pharmacokinetics of drugs. In adults, obesity was found to influence important drug-metabolising enzyme pathways. The impact...... of obesity-related alterations on drug metabolism and its consequences for drug dosing remains largely unknown in both children and adults. An altered drug metabolism may contribute significantly to therapeutic failure or toxicity. The aim of this trial is to investigate the in vivo activity of CYP3A4, CYP2E......1 and CYP1A2 substrates in obese versus non-obese children. METHODS: The CYTONOX trial is an open-label explorative pharmacokinetic trial. We intend to include 50 obese and 50 non-obese children. The primary end points are: in vivo clearance of CYP3A4, CYP2E1 and CYP1A2 substrates, which...

Weight loss intervention for young adults using mobile technology: design and rationale of a randomized controlled trial - Cell Phone Intervention for You (CITY).

Science.gov (United States)

Batch, Bryan C; Tyson, Crystal; Bagwell, Jacqueline; Corsino, Leonor; Intille, Stephen; Lin, Pao-Hwa; Lazenka, Tony; Bennett, Gary; Bosworth, Hayden B; Voils, Corrine; Grambow, Steven; Sutton, Aziza; Bordogna, Rachel; Pangborn, Matthew; Schwager, Jenifer; Pilewski, Kate; Caccia, Carla; Burroughs, Jasmine; Svetkey, Laura P

2014-03-01

The obesity epidemic has spread to young adults, leading to significant public health implications later in adulthood. Intervention in early adulthood may be an effective public health strategy for reducing the long-term health impact of the epidemic. Few weight loss trials have been conducted in young adults. It is unclear what weight loss strategies are beneficial in this population. To describe the design and rationale of the NHLBI-sponsored Cell Phone Intervention for You (CITY) study, which is a single center, randomized three-arm trial that compares the impact on weight loss of 1) a behavioral intervention that is delivered almost entirely via cell phone technology (Cell Phone group); and 2) a behavioral intervention delivered mainly through monthly personal coaching calls enhanced by self-monitoring via cell phone (Personal Coaching group), each compared to 3) a usual care, advice-only control condition. A total of 365 community-dwelling overweight/obese adults aged 18-35 years were randomized to receive one of these three interventions for 24 months in parallel group design. Study personnel assessing outcomes were blinded to group assignment. The primary outcome is weight change at 24 [corrected] months. We hypothesize that each active intervention will cause more weight loss than the usual care condition. Study completion is anticipated in 2014. If effective, implementation of the CITY interventions could mitigate the alarming rates of obesity in young adults through promotion of weight loss. ClinicalTrial.gov: NCT01092364. Published by Elsevier Inc.

The impact of insecticide-treated school uniforms on dengue infections in school-aged children: study protocol for a randomised controlled trial in Thailand

Directory of Open Access Journals (Sweden)

Wilder-Smith Annelies

2012-11-01

Full Text Available Abstract Background There is an urgent need to protect children against dengue since this age group is particularly sensitive to the disease. Since dengue vectors are active mainly during the day, a potential target for control should be schools where children spend a considerable amount of their day. School uniforms are the cultural norm in most developing countries, worn throughout the day. We hypothesise that insecticide-treated school uniforms will reduce the incidence of dengue infection in school-aged children. Our objective is to determine the impact of impregnated school uniforms on dengue incidence. Methods A randomised controlled trial will be conducted in eastern Thailand in a group of schools with approximately 2,000 students aged 7–18 years. Pre-fabricated school uniforms will be commercially treated to ensure consistent, high-quality insecticide impregnation with permethrin. A double-blind, randomised, crossover trial at the school level will cover two dengue transmission seasons. Discussion Practical issues and plans concerning intervention implementation, evaluation, analysing and interpreting the data, and possible policy implications arising from the trial are discussed. Trial registration clinicaltrial.gov. Registration number: NCT01563640

Impact of Contextual Factors on the Effect of Interventions to Improve Health Worker Performance in Sub-Saharan Africa: Review of Randomised Clinical Trials

Science.gov (United States)

Mickan, Sharon; Willcox, Merlin; Roberts, Nia; Bergström, Anna; Mant, David

2016-01-01

Background Africa bears 24% of the global burden of disease but has only 3% of the world’s health workers. Substantial variation in health worker performance adds to the negative impact of this significant shortfall. We therefore sought to identify interventions implemented in sub-Saharan African aiming to improve health worker performance and the contextual factors likely to influence local effectiveness. Methods and Findings A systematic search for randomised controlled trials of interventions to improve health worker performance undertaken in sub-Saharan Africa identified 41 eligible trials. Data were extracted to define the interventions’ components, calculate the absolute improvement in performance achieved, and document the likelihood of bias. Within-study variability in effect was extracted where reported. Statements about contextual factors likely to have modified effect were subjected to thematic analysis. Interventions to improve health worker performance can be very effective. Two of the three trials assessing mortality impact showed significant reductions in death rates (agematernal in-hospital mortality 6.8/1000 versus 10.3/1000; pimprovement varying from 9% to 48%. However, reported range of improvement between centres within trials varied substantially, in many cases exceeding the mean effect. Nine contextual themes were identified as modifiers of intervention effect across studies; most frequently cited were supply-line failures, inadequate supervision or management, and failure to follow-up training interventions with ongoing support, in addition to staff turnover. Conclusions Interventions to improve performance of existing staff and service quality have the potential to improve patient care in underserved settings. But in order to implement interventions effectively, policy makers need to understand and address the contextual factors which can contribute to differences in local effect. Researchers therefore must recognise the importance of

HOW TO CALL THE CERN FIRE BRIGADE

CERN Multimedia

2002-01-01

The telephone numbers of the CERN Fire Brigade are: 74444 for emergency calls 74848 for other calls Note The number 112 will stay in use for emergency calls from 'wired' telephones, however, from mobile phones it leads to non-CERN emergency services.  

HOW TO CALL THE CERN FIRE BRIGADE

CERN Multimedia

2002-01-01

The telephone numbers of the CERN Fire Brigade are: 74444 for emergency calls 74848 for other calls Note The number 112 will stay in use for emergency calls from 'wired' telephones, however, from mobile phones it leads to non-CERN emergency services.

HOW TO CALL THE CERN FIRE BRIGADE

CERN Multimedia

2001-01-01

The telephone numbers of the CERN Fire Brigade are: 74444 for emergency calls 74848 for other calls Note The number 112 will stay in use for emergency calls from 'wired' telephones, however, from mobile phones it leads to non-CERN emergency services.

HOW TO CALL THE CERN FIRE BRIGADE

CERN Multimedia

2001-01-01

The telephone numbers of the CERN Fire Brigade are: 74444 for emergency calls 74848 for other calls Note: the number 112 will stay in use for emergency calls from 'wired' telephones, however, from mobile phones it leads to non-CERN emergency services.

Transforming trauma healthcare delivery in rural areas by use of an integrated call center.

Science.gov (United States)

Agrawal, Deepak

2012-01-01

There is poor penetration of trauma healthcare delivery in rural areas. On the other hand, mobile penetration in India is now averaging 80% with most families having access to mobile phone. The aim of this study was to assess the implementation and socioeconomic impact of a call center in providing healthcare delivery for patients with head and spinal injuries. This was a prospective observational study carried out over a 6-month period at a level I trauma Center in New Delhi, India. A nine-seater call center was outsourced to a private company and the hospital's electronic medical records were integrated with the call-center operations. The call center was given responsibility of maintaining appointments and scheduling clinics for the whole hospital as well as ensuring follow-up visits. Trained call-center staff handled simple patient queries and referred the rest via email to concerned doctors. A telephonic survey was done prior to the start of call-center operations and after 3 months to assess for user satisfaction. The initial cost of outsourcing the call center was Rs 1.6 lakhs (US$ 4000), with a recurring cost of Rs 80,000 (US$ 2000) per month. A total of 484 patients were admitted in the department of Neurosurgery during the study period. Of these, 63% (n=305) were from rural areas. Patients' overall experience for clinic visits improved markedly following implementation of call center. Patient satisfaction for follow-up visits increased from a mean of 32-96%. Ninety-five percent patients reported a significant decrease in waiting time in clinics 80.4% reporting improved doctor-patient interaction. A total of 52 visits could be postponed/cancelled for patients living in far flung areas resulting in major socioeconomic benefits to these families. As shown by our case study, call centers have the potential to revolutionize delivery of trauma healthcare to rural areas in an extremely cost-effective manner.

Transforming trauma healthcare delivery in rural areas by use of an integrated call center

Directory of Open Access Journals (Sweden)

Deepak Agrawal

2012-01-01

Full Text Available Introduction: There is poor penetration of trauma healthcare delivery in rural areas. On the other hand, mobile penetration in India is now averaging 80% with most families having access to mobile phone. Aims and Objectives: The aim of this study was to assess the implementation and socioeconomic impact of a call center in providing healthcare delivery for patients with head and spinal injuries. Materials and Methods: This was a prospective observational study carried out over a 6-month period at a level I trauma Center in New Delhi, India. A nine-seater call center was outsourced to a private company and the hospital′s electronic medical records were integrated with the call-center operations. The call center was given responsibility of maintaining appointments and scheduling clinics for the whole hospital as well as ensuring follow-up visits. Trained call-center staff handled simple patient queries and referred the rest via email to concerned doctors. A telephonic survey was done prior to the start of call-center operations and after 3 months to assess for user satisfaction. Results: The initial cost of outsourcing the call center was Rs 1.6 lakhs (US$ 4000, with a recurring cost of Rs 80,000 (US$ 2000 per month. A total of 484 patients were admitted in the department of Neurosurgery during the study period. Of these, 63% (n=305 were from rural areas. Patients′ overall experience for clinic visits improved markedly following implementation of call center. Patient satisfaction for follow-up visits increased from a mean of 32-96%. Ninety-five percent patients reported a significant decrease in waiting time in clinics 80.4% reporting improved doctor-patient interaction. A total of 52 visits could be postponed/cancelled for patients living in far flung areas resulting in major socioeconomic benefits to these families. Conclusions: As shown by our case study, call centers have the potential to revolutionize delivery of trauma healthcare to

Transforming trauma healthcare delivery in rural areas by use of an integrated call center

Science.gov (United States)

Agrawal, Deepak

2012-01-01

Introduction: There is poor penetration of trauma healthcare delivery in rural areas. On the other hand, mobile penetration in India is now averaging 80% with most families having access to mobile phone. Aims and Objectives: The aim of this study was to assess the implementation and socioeconomic impact of a call center in providing healthcare delivery for patients with head and spinal injuries. Materials and Methods: This was a prospective observational study carried out over a 6-month period at a level I trauma Center in New Delhi, India. A nine-seater call center was outsourced to a private company and the hospital's electronic medical records were integrated with the call-center operations. The call center was given responsibility of maintaining appointments and scheduling clinics for the whole hospital as well as ensuring follow-up visits. Trained call-center staff handled simple patient queries and referred the rest via email to concerned doctors. A telephonic survey was done prior to the start of call-center operations and after 3 months to assess for user satisfaction. Results: The initial cost of outsourcing the call center was Rs 1.6 lakhs (US$ 4000), with a recurring cost of Rs 80,000 (US$ 2000) per month. A total of 484 patients were admitted in the department of Neurosurgery during the study period. Of these, 63% (n=305) were from rural areas. Patients’ overall experience for clinic visits improved markedly following implementation of call center. Patient satisfaction for follow-up visits increased from a mean of 32-96%. Ninety-five percent patients reported a significant decrease in waiting time in clinics 80.4% reporting improved doctor-patient interaction. A total of 52 visits could be postponed/cancelled for patients living in far flung areas resulting in major socioeconomic benefits to these families. Conclusions: As shown by our case study, call centers have the potential to revolutionize delivery of trauma healthcare to rural areas in an

Telephone calls by individuals with cancer.

Science.gov (United States)

Flannery, Marie; McAndrews, Leanne; Stein, Karen F

2013-09-01

To describe symptom type and reporting patterns found in spontaneously initiated telephone calls placed to an ambulatory cancer center practice. Retrospective, descriptive. Adult hematology oncology cancer center. 563 individuals with a wide range of oncology diagnoses who initiated 1,229 telephone calls to report symptoms. Raw data were extracted from telephone forms using a data collection sheet with 23 variables obtained for each phone call, using pre-established coding criteria. A literature-based, investigator-developed instrument was used for the coding criteria and selection of which variables to extract. Symptom reporting, telephone calls, pain, and symptoms. A total of 2,378 symptoms were reported by telephone during the four months. At least 10% of the sample reported pain (38%), fatigue (16%), nausea (16%), swelling (12%), diarrhea (12%), dyspnea (10%), and anorexia (10%). The modal response was to call only one time and to report only one symptom (55%). Pain emerged as the symptom that most often prompted an individual to pick up the telephone and call. Although variation was seen in symptom reporting, an interesting pattern emerged with an individual reporting on a solitary symptom in a single telephone call. The emergence of pain as the primary symptom reported by telephone prompted educational efforts for both in-person clinic visit management of pain and prioritizing nursing education and protocol management of pain reported by telephone. Report of symptoms by telephone can provide nurses unique insight into patient-centered needs. Although pain has been an important focus of education and research for decades, it remains a priority for individuals with cancer. A wide range in symptom reporting by telephone was evident.

Experiences of a long-term randomized controlled prevention trial in a maiden environment: Estonian Postmenopausal Hormone Therapy trial

Directory of Open Access Journals (Sweden)

Rahu Mati

2008-08-01

Full Text Available Abstract Background Preventive drugs require long-term trials to show their effectiveness or harms and often a lot of changes occur during post-marketing studies. The purpose of this article is to describe the research process in a long-term randomized controlled trial and discuss the impact and consequences of changes in the research environment. Methods The Estonian Postmenopausal Hormone Therapy trial (EPHT, originally planned to continue for five years, was planned in co-operation with the Women's International Study of Long-Duration Oestrogen after Menopause (WISDOM in the UK. In addition to health outcomes, EPHT was specifically designed to study the impact of postmenopausal hormone therapy (HT on health services utilization. Results After EPHT recruited in 1999–2001 the Women's Health Initiative (WHI in the USA decided to stop the estrogen-progestin trial after a mean of 5.2 years in July 2002 because of increased risk of breast cancer and later in 2004 the estrogen-only trial because HT increased the risk of stroke, decreased the risk of hip fracture, and did not affect coronary heart disease incidence. WISDOM was halted in autumn 2002. These decisions had a major influence on EPHT. Conclusion Changes in Estonian society challenged EPHT to find a balance between the needs of achieving responses to the trial aims with a limited budget and simultaneously maintaining the safety of trial participants. Flexibility was the main key for success. Rapid changes are not limited only to transiting societies but are true also in developed countries and the risk must be included in planning all long-term trials. The role of ethical and data monitoring committees in situations with emerging new data from other studies needs specification. Longer funding for preventive trials and more flexibility in budgeting are mandatory. Who should prove the effectiveness of an (old drug for a new preventive indication? In preventive drug trials companies may

Outsourcing an Effective Postdischarge Call Program

Science.gov (United States)

Meek, Kevin L.; Williams, Paula; Unterschuetz, Caryn J.

2018-01-01

To improve patient satisfaction ratings and decrease readmissions, many organizations utilize internal staff to complete postdischarge calls to recently released patients. Developing, implementing, monitoring, and sustaining an effective call program can be challenging and have eluded some of the renowned medical centers in the country. Using collaboration with an outsourced vendor to bring state-of-the-art call technology and staffed with specially trained callers, health systems can achieve elevated levels of engagement and satisfaction for their patients postdischarge. PMID:29494453

Calling to Nursing: Concept Analysis.

Science.gov (United States)

Emerson, Christie

The aims of this article are (a) to analyze the concept of a calling as it relates nursing and (b) to develop a definition of calling to nursing with the detail and clarity needed to guide reliable and valid research. The classic steps described by Walker and Avant are used for the analysis. Literature from several disciplines is reviewed including vocational psychology, Christian career counseling, sociology, organizational management, and nursing. The analysis provides an operational definition of a calling to nursing and establishes 3 defining attributes of the concept: (a) a passionate intrinsic motivation or desire (perhaps with a religious component), (b) an aspiration to engage in nursing practice, as a means of fulfilling one's purpose in life, and (c) the desire to help others as one's purpose in life. Antecedents to the concept are personal introspection and cognitive awareness. Positive consequences to the concept are improved work meaningfulness, work engagement, career commitment, personal well-being, and satisfaction. Negative consequences of having a calling might include willingness to sacrifice well-being for work and problems with work-life balance. Following the concept analysis, philosophical assumptions, contextual factors, interdisciplinary work, research opportunities, and practice implications are discussed.

The impact of tropospheric ozone pollution on trial plot winter wheat yields in Great Britain - An econometric approach

International Nuclear Information System (INIS)

Kaliakatsou, Evridiki; Bell, J. Nigel B.; Thirtle, Colin; Rose, Daniel; Power, Sally A.

2010-01-01

Numerous experiments have demonstrated reductions in the yields of cereal crops due to tropospheric O 3 , with losses of up to 25%. However, the only British econometric study on O 3 impacts on winter wheat yields, found that a 10% increase in AOT40 would decrease yields by only 0.23%. An attempt is made here to reconcile these observations by developing AOT40 maps for Great Britain and matching levels with a large number of standardised trial plot wheat yields from many sites over a 13-year period. Panel estimates (repeated measures on the same plots with time) show a 0.54% decrease in yields and it is hypothesised that plant breeders may have inadvertently selected for O 3 tolerance in wheat. Some support for this is provided by fumigations of cultivars of differing introduction dates. A case is made for the use of econometric as well as experimental studies in prediction of air pollution induced crop loss. - Econometric study of British winter wheat trial plot data suggests lower economic loss than predicted from experiments.

Participants as community-based peer educators: Impact on a clinical trial site in KwaZulu-Natal

Directory of Open Access Journals (Sweden)

Sarita Naidoo

2013-07-01

Full Text Available Participant recruitment, retention and product adherence are necessary to measure the efficacy or effectiveness of an intervention in a clinical trial. As part of a Phase III HIV prevention trial in a rural area in Kwazulu-Natal, South Africa, a peer educator programme was initiated to aid in recruitment and retention of trial participants from the community. Enrolled trial participants who had completed at least 6 months of trial participation and who had honoured all of their scheduled trial visits within that period were approached to be peer educators. Following additional selection criteria, 24 participants were eligible to be trained as peer educators. Training topics included HIV/AIDS, sexually transmitted infections, nutrition, antiretrovirals, clinical trials, and methods of disseminating this information to the community. The role of peer educators was to bring interested women from their community to the trial site for comprehensive education and information about the trial and possibly trial participation. A total of 1879 women were educated by peer educators between July 2004 and December 2006. Of these, 553 women visited the trial site for further education and screening for participation in the trial. Peer educators provided continuous education and support to women enrolled in the trial which also promoted retention, ultimately contributing to the site's 94% retention rate. Recruitment and retention efforts of trial participants are likely to be enhanced by involving trial participants as peer educators. Such trial participants are in a better position to understand cultural dynamics and hence capable of engaging the community with appropriate HIV prevention and trial-related messaging.

The impact of radiologists' expertise on screen results decisions in a CT lung cancer screening trial

International Nuclear Information System (INIS)

Heuvelmans, Marjolein A.; Vliegenthart, Rozemarijn; Oudkerk, Matthijs; Jong, Pim A. de; Mali, Willem P.; Groen, Harry J.M.

2015-01-01

To evaluate the impact of radiological expertise on screen result decisions in a CT lung cancer screening trial. In the NELSON lung cancer screening trial, the baseline CT result was based on the largest lung nodule's volume. The protocol allowed radiologists to manually adjust screen results in cases of high suspicion of benign or malignant nodule nature. Participants whose baseline CT result was based on a solid or part-solid nodule were included in this study. Adjustments by radiologists at baseline were evaluated. Histology was the reference for diagnosis or to confirm benignity and stability on subsequent CT examinations. A total of 3,318 participants (2,796 male, median age 58.0 years) were included. In 195 participants (5.9 %) the initial baseline screen result was adjusted by the radiologist. Adjustment was downwards from positive or indeterminate to negative in two and 119 participants, respectively, and from positive to indeterminate in 65 participants. None of these nodules turned out to be malignant. In 9/195 participants (4.6 %) the screen result was adjusted upwards from negative to indeterminate or indeterminate to positive; two nodules were malignant. In one in 20 cases of baseline lung cancer screening, nodules were reclassified by the radiologist, leading to a reduction of false-positive screen results. (orig.)

Impact of Race Versus Education and Race Versus Income on Patients' Motivation to Participate in Clinical Trials.

Science.gov (United States)

Kurt, Anita; Kincaid, Hope; Semler, Lauren; Jacoby, Jeanne L; Johnson, Melanie B; Careyva, Beth A; Stello, Brian; Friel, Timothy; Smulian, John C; Knouse, Mark C

2017-12-26

Our study investigates whether levels of motivation and barriers to participation in clinical trials vary with patients' education and income. A self-administered survey asked outpatients to rank potential influential factors on a "0" to "4" significance scale for their motivation to participate in clinical trials. Principal component analysis (PCA), analysis of variance (ANOVA), Kruskal-Wallis, and Mann-Whitney U tests analyzed the impact of race, education, and income on their motivation to participate. Analysis included 1841 surveys; most respondents had a high school education or some college, and listed annual income motivation scale 1 scores (p = .0261). Compared with their counterparts, subjects with less education/lower income ranked monetary compensation (p = .0420 and p motivator. Minorities and patients with less education and lower income appear to be more influenced by their desire to please the doctor, the race and sex of the doctor, and the language spoken by the doctor being the same as theirs. For all races, education appeared to have a direct relationship with motivation to participate, except for African-Americans, whose motivation appeared to decline with more education. Income appeared to have an inverse relationship with motivation to participate for all races.

EMERGENCY CALLS

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Medical Service

2001-01-01

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Critical concepts in adaptive clinical trials

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Park JJH

2018-03-01

Full Text Available Jay JH Park,1 Kristian Thorlund,2,3 Edward J Mills2,3 1Department of Medicine, University of British Columbia, Vancouver, BC, Canada; 2Department of Health Research Methods, Evidence, and Impact (HEI, McMaster University, Hamilton, ON, Canada; 3The Bill and Melinda Gates Foundation, Seattle, WA, USA Abstract: Adaptive clinical trials are an innovative trial design aimed at reducing resources, decreasing time to completion and number of patients exposed to inferior interventions, and improving the likelihood of detecting treatment effects. The last decade has seen an increasing use of adaptive designs, particularly in drug development. They frequently differ importantly from conventional clinical trials as they allow modifications to key trial design components during the trial, as data is being collected, using preplanned decision rules. Adaptive designs have increased likelihood of complexity and also potential bias, so it is important to understand the common types of adaptive designs. Many clinicians and investigators may be unfamiliar with the design considerations for adaptive designs. Given their complexities, adaptive trials require an understanding of design features and sources of bias. Herein, we introduce some common adaptive design elements and biases and specifically address response adaptive randomization, sample size reassessment, Bayesian methods for adaptive trials, seamless trials, and adaptive enrichment using real examples. Keywords: adaptive designs, response adaptive randomization, sample size reassessment, Bayesian adaptive trials, seamless trials, adaptive enrichment

The suitability of polycystic ovary syndrome-specific questionnaires for measuring the impact of PCOS on quality of life in clinical trials.

Science.gov (United States)

Malik-Aslam, Aysha; Reaney, Matthew D; Speight, Jane

2010-01-01

Generic patient-reported outcome (PRO) measures underestimate the impact of polycystic ovary syndrome (PCOS) on quality of life (QoL). The aim of this review was to identify PCOS-specific QoL measures and establish whether their development history and measurement properties support their use in clinical trials. A systematic search was conducted using terms synonymous with "PCOS" and "QoL." Following identification of measures, further searches were undertaken using the questionnaire name and abbreviation to explore its use, development history, and demonstrated measurement properties. Of 56 abstracts screened, 21 reported using PRO measures. One PCOS-specific QoL measure was identified: the PolyCystic Ovary Syndrome Questionnaire (PCOSQ). Nine papers show that the PCOSQ's development history is somewhat incomplete, and that it does not have good content validity. The PCOSQ subscales demonstrate acceptable levels of reliability (0.70-0.97) and partial known-groups validity as well as convergent/divergent validity with other PRO instruments. Responsiveness to change is variable and minimally important differences have not been established. The PCOSQ is the only condition-specific measure of the impact of PCOS on QoL. Additional research is required to ensure its comprehensiveness, sensitivity, and to guide interpretation prior to including in clinical trials.

How do "mute" cicadas produce their calling songs?

Directory of Open Access Journals (Sweden)

Changqing Luo

Full Text Available Insects have evolved a variety of structures and mechanisms to produce sounds, which are used for communication both within and between species. Among acoustic insects, cicada males are particularly known for their loud and diverse sounds which function importantly in communication. The main method of sound production in cicadas is the tymbal mechanism, and a relative small number of cicada species possess both tymbal and stridulatory organs. However, cicadas of the genus Karenia do not have any specialized sound-producing structures, so they are referred to as "mute". This denomination is quite misleading, as they indeed produce sounds. Here, we investigate the sound-producing mechanism and acoustic communication of the "mute" cicada, Karenia caelatata, and discover a new sound-production mechanism for cicadas: i.e., K. caelatata produces impact sounds by banging the forewing costa against the operculum. The temporal, frequency and amplitude characteristics of the impact sounds are described. Morphological studies and reflectance-based analyses reveal that the structures involved in sound production of K. caelatata (i.e., forewing, operculum, cruciform elevation, and wing-holding groove on scutellum are all morphologically modified. Acoustic playback experiments and behavioral observations suggest that the impact sounds of K. caelatata are used in intraspecific communication and function as calling songs. The new sound-production mechanism expands our knowledge on the diversity of acoustic signaling behavior in cicadas and further underscores the need for more bioacoustic studies on cicadas which lack tymbal mechanism.

How do "mute" cicadas produce their calling songs?

Science.gov (United States)

Luo, Changqing; Wei, Cong; Nansen, Christian

2015-01-01

Insects have evolved a variety of structures and mechanisms to produce sounds, which are used for communication both within and between species. Among acoustic insects, cicada males are particularly known for their loud and diverse sounds which function importantly in communication. The main method of sound production in cicadas is the tymbal mechanism, and a relative small number of cicada species possess both tymbal and stridulatory organs. However, cicadas of the genus Karenia do not have any specialized sound-producing structures, so they are referred to as "mute". This denomination is quite misleading, as they indeed produce sounds. Here, we investigate the sound-producing mechanism and acoustic communication of the "mute" cicada, Karenia caelatata, and discover a new sound-production mechanism for cicadas: i.e., K. caelatata produces impact sounds by banging the forewing costa against the operculum. The temporal, frequency and amplitude characteristics of the impact sounds are described. Morphological studies and reflectance-based analyses reveal that the structures involved in sound production of K. caelatata (i.e., forewing, operculum, cruciform elevation, and wing-holding groove on scutellum) are all morphologically modified. Acoustic playback experiments and behavioral observations suggest that the impact sounds of K. caelatata are used in intraspecific communication and function as calling songs. The new sound-production mechanism expands our knowledge on the diversity of acoustic signaling behavior in cicadas and further underscores the need for more bioacoustic studies on cicadas which lack tymbal mechanism.

Crime and Punishment: the Impact of Skin Color and Socioeconomic Status of Defendants and Victims in Jury Trials in Brazil.

Science.gov (United States)

da Silva, Rogério Ferreira; Oliveira Lima, Marcus Eugênio

2016-11-14

Social judgments are often influenced by racism. Voluntary crimes against life, and in particular the crime of homicide, may be the most critical situations of the impact of racism in social judgments. We analyzed 114 homicide trials conducted by the 1st Jury Court, in a Brazilian judicial capital, concluded between 2003 and 2007, for the purpose of investigating the effects of skin color and the socioeconomic status of the defendant and the victim of homicides in the jury trial court's decision. The results indicate that the social and economic profile of defendants and victims of homicide is identical. They are almost all poor (more than 70%), with low education (more than 73%) and frequently non-Whites (more than 88%). We found that judges assign longer sentences to black (β = .34, p = .01) and poor defendants (β = .23, p socioeconomic status in social judgments and in discrimination.

TPMG Northern California appointments and advice call center.

Science.gov (United States)

Conolly, Patricia; Levine, Leslie; Amaral, Debra J; Fireman, Bruce H; Driscoll, Tom

2005-08-01

Kaiser Permanente (KP) has been developing its use of call centers as a way to provide an expansive set of healthcare services to KP members efficiently and cost effectively. Since 1995, when The Permanente Medical Group (TPMG) began to consolidate primary care phone services into three physical call centers, the TPMG Appointments and Advice Call Center (AACC) has become the "front office" for primary care services across approximately 89% of Northern California. The AACC provides primary care phone service for approximately 3 million Kaiser Foundation Health Plan members in Northern California and responds to approximately 1 million calls per month across the three AACC sites. A database records each caller's identity as well as the day, time, and duration of each call; reason for calling; services provided to callers as a result of calls; and clinical outcomes of calls. We here summarize this information for the period 2000 through 2003.

Non-sedation versus sedation with a daily wake-up trial in critically ill patients receiving mechanical ventilation (NONSEDA Trial)

DEFF Research Database (Denmark)

Toft, Palle; Olsen, Hanne Tanghus; Jørgensen, Helene Korvenius

2014-01-01

comparing sedation with no sedation, a priori powered to have all-cause mortality as primary outcome.The objective is to assess the benefits and harms of non-sedation versus sedation with a daily wake-up trial in critically ill patients. METHODS: The non-sedation (NONSEDA) trial is an investigator......-sedation supplemented with pain management during mechanical ventilation.Control intervention is sedation with a daily wake-up trial.The primary outcome will be all cause mortality at 90 days after randomization. Secondary outcomes will be: days until death throughout the total observation period; coma- and delirium...... in mortality with a type I error risk of 5% and a type II error risk of 20% (power at 80%). DISCUSSION: The trial investigates potential benefits of non-sedation. This might have large impact on the future treatment of mechanically ventilated critically ill patients.Trial register: ClinicalTrials.gov NCT...

Trial type probability modulates the cost of antisaccades

Science.gov (United States)

Chiau, Hui-Yan; Tseng, Philip; Su, Jia-Han; Tzeng, Ovid J. L.; Hung, Daisy L.; Muggleton, Neil G.

2011-01-01

The antisaccade task, where eye movements are made away from a target, has been used to investigate the flexibility of cognitive control of behavior. Antisaccades usually have longer saccade latencies than prosaccades, the so-called antisaccade cost. Recent studies have shown that this antisaccade cost can be modulated by event probability. This may mean that the antisaccade cost can be reduced, or even reversed, if the probability of surrounding events favors the execution of antisaccades. The probabilities of prosaccades and antisaccades were systematically manipulated by changing the proportion of a certain type of trial in an interleaved pro/antisaccades task. We aimed to disentangle the intertwined relationship between trial type probabilities and the antisaccade cost with the ultimate goal of elucidating how probabilities of trial types modulate human flexible behaviors, as well as the characteristics of such modulation effects. To this end, we examined whether implicit trial type probability can influence saccade latencies and also manipulated the difficulty of cue discriminability to see how effects of trial type probability would change when the demand on visual perceptual analysis was high or low. A mixed-effects model was applied to the analysis to dissect the factors contributing to the modulation effects of trial type probabilities. Our results suggest that the trial type probability is one robust determinant of antisaccade cost. These findings highlight the importance of implicit probability in the flexibility of cognitive control of behavior. PMID:21543748

Parents' perceived obstacles to pediatric clinical trial participation: Findings from the clinical trials transformation initiative.

Science.gov (United States)

Greenberg, Rachel G; Gamel, Breck; Bloom, Diane; Bradley, John; Jafri, Hasan S; Hinton, Denise; Nambiar, Sumathi; Wheeler, Chris; Tiernan, Rosemary; Smith, P Brian; Roberts, Jamie; Benjamin, Daniel K

2018-03-01

Enrollment of children into pediatric clinical trials remains challenging. More effective strategies to improve recruitment of children into trials are needed. This study used in-depth qualitative interviews with parents who were approached to enroll their children in a clinical trial in order to gain an understanding of the barriers to pediatric clinical trial participation. Twenty-four parents whose children had been offered the opportunity to participate in a clinical trial were interviewed: 19 whose children had participated in at least 1 clinical trial and 5 who had declined participation in any trial. Each study aspect, from the initial explanation of the study to the end of the study, can affect the willingness of parents to consent to the proposed study and future studies. Establishing trust, appropriate timing, a transparent discussion of risks and benefits oriented to the layperson, and providing motivation for children to participate were key factors that impacted parents' decisions. In order for clinical trial accrual to be successful, parents' priorities and considerations must be a central focus, beginning with initial trial design. The recommendations from the parents who participated in this study can be used to support budget allocations that ensure adequate training of study staff and improved staffing on nights and weekends. Studies of parent responses in outpatient settings and additional inpatient settings will provide valuable information on the consent process from the child's and parent's perspectives. Further studies are needed to explore whether implementation of such strategies will result in improved recruitment for pediatric clinical trials.

American Heart Association's Call to Action for Payment and Delivery System Reform.

Science.gov (United States)

Bufalino, Vincent J; Berkowitz, Scott A; Gardner, Timothy J; Piña, Ileana L; Konig, Madeleine

2017-08-15

The healthcare system is undergoing a transition from paying for volume to paying for value. Clinicians, as well as public and private payers, are beginning to implement alternative delivery and payment models, such as the patient-centered medical home, accountable care organizations, and bundled payment arrangements. Implementation of these new models will necessitate delivery system transformation and will actively involve all fields of medical care, in particular medicine and surgery. This call to action, on behalf of the American Heart Association's Expert Panel on Payment and Delivery System Reform, serves to offer support and direction for further involvement by the American Heart Association. In doing so, it (1) provides baseline review and definition of the present models and some of the early results of these delivery models, including outcomes; (2) initiates a conversation within the American Heart Association on the impact of payment and delivery system reform, as well as how the American Heart Association should engage in the interest of patients; (3) issues a call to action to our organization and to cardiovascular and stroke health professionals across the country to become educated about these models so to as to understand their impact on patient care; and (4) asks the government and other funding agencies, including the American Heart Association, to begin supporting and prioritizing meaningful research endeavors to further evaluate these models. © 2017 American Heart Association, Inc.

The impact of farmers’ participation in field trials in creating awareness and stimulating compliance with the World Health Organization’s farm-based multiple-barrier approach

DEFF Research Database (Denmark)

Amponsah, Owusu; Vigre, Håkan; Schou, Torben Wilde

2016-01-01

-barrier approach field trials. The results of the study show that participation in the field trials has statistically significant effects on farmers’ awareness of the farm-based multiple-barrier approach. Compliance has, however, been undermined by the farmers’ perception that the cost of compliance is more......The results of a study aimed as assessing the extent to which urban vegetable farmers’ participation in field trials can impact on their awareness and engender compliance with the World Health Organization’s farm-based multiple-barrier approach are presented in this paper. Both qualitative...... and quantitative approaches have been used in this paper. One hundred vegetable farmers and four vegetable farmers’ associations in the Kumasi Metropolis in Ghana were covered. The individual farmers were grouped into two, namely: (1) participants and (2) non-participants of the farm-based multiple...

Relationship between burnout and PTSD symptoms in firefighters: the moderating effects of a sense of calling to firefighting.

Science.gov (United States)

Jo, Insung; Lee, Songhee; Sung, Gyhye; Kim, Minkyoung; Lee, Sanghyuk; Park, Jooeon; Lee, Kangsoo

2018-01-01

Firefighting has been reported to lead to burnout and posttraumatic stress disorder (PTSD). However, burnout and PTSD symptoms may vary depending on personal characteristics, such as having a sense of calling. This study examined the role of calling in the association between burnout and PTSD symptoms. We hypothesized that burnout would be associated with more severe PTSD symptoms and calling would buffer the relationship between burnout and PTSD symptoms. The Korean version of the Maslach Burnout Inventory-General Survey, Sense of Calling Subscale of the Professionalism Scale, and the Impact of Event Scale-Revised-Korean version were used to measure burnout, calling, and PTSD symptoms. Data from 109 of 127 firefighters from Gyeonggi-do, South Korea were analyzed using hierarchical linear regression. Burnout was a significant predictor of PTSD symptoms. Furthermore, the interaction term between burnout and calling accounted for a significant variance in PTSD symptoms. Higher burnout was associated with severe PTSD symptoms, but this relationship differed by the level of calling. The increase in PTSD symptoms due to increased burnout in the high calling group was relatively higher than in the low and average calling groups. Calling, though perceived as a positive variable, can be hazardous to exhausted people. A sense of calling as part of one's job identity should not be encouraged until personal circumstances and characteristics, such burnout symptoms, are evaluated. Identifying context and variables associated with PTSD for interventions with firefighters and persons in other dangerous occupations should aid in their recovery from trauma exposure.

Impact of an indigenous microbial enhanced oil recovery field trial on microbial community structure in a high pour-point oil reservoir

Energy Technology Data Exchange (ETDEWEB)

Zhang, Fan; Zhang, Xiao-Tao; Hou, Du-Jie [China Univ. of Geosciences, Beijing (China). The Key Lab. of Marine Reservoir Evolution and Hydrocarbon Accumulation Mechanism; She, Yue-Hui [Yangtze Univ., Jingzhou, Hubei (China). College of Chemistry and Environmental Engineering; Huazhong Univ. of Science and Technology, Wuhan (China). College of Life Science and Technology; Li, Hua-Min [Beijing Bioscience Research Center (China); Shu, Fu-Chang; Wang, Zheng-Liang [Yangtze Univ., Jingzhou, Hubei (China). College of Chemistry and Environmental Engineering; Yu, Long-Jiang [Huazhong Univ. of Science and Technology, Wuhan (China). College of Life Science and Technology

2012-08-15

Based on preliminary investigation of microbial populations in a high pour-point oil reservoir, an indigenous microbial enhanced oil recovery (MEOR) field trial was carried out. The purpose of the study is to reveal the impact of the indigenous MEOR process on microbial community structure in the oil reservoir using 16Sr DNA clone library technique. The detailed monitoring results showed significant response of microbial communities during the field trial and large discrepancies of stimulated microorganisms in the laboratory and in the natural oil reservoir. More specifically, after nutrients injection, the original dominant populations of Petrobacter and Alishewanella in the production wells almost disappeared. The expected desirable population of Pseudomonas aeruginosa, determined by enrichment experiments in laboratory, was stimulated successfully in two wells of the five monitored wells. Unexpectedly, another potential population of Pseudomonas pseudoalcaligenes which were not detected in the enrichment culture in laboratory was stimulated in the other three monitored production wells. In this study, monitoring of microbial community displayed a comprehensive alteration of microbial populations during the field trial to remedy the deficiency of culture-dependent monitoring methods. The results would help to develop and apply more MEOR processes. (orig.)

Impact of an indigenous microbial enhanced oil recovery field trial on microbial community structure in a high pour-point oil reservoir.

Science.gov (United States)

Zhang, Fan; She, Yue-Hui; Li, Hua-Min; Zhang, Xiao-Tao; Shu, Fu-Chang; Wang, Zheng-Liang; Yu, Long-Jiang; Hou, Du-Jie

2012-08-01

Based on preliminary investigation of microbial populations in a high pour-point oil reservoir, an indigenous microbial enhanced oil recovery (MEOR) field trial was carried out. The purpose of the study is to reveal the impact of the indigenous MEOR process on microbial community structure in the oil reservoir using 16Sr DNA clone library technique. The detailed monitoring results showed significant response of microbial communities during the field trial and large discrepancies of stimulated microorganisms in the laboratory and in the natural oil reservoir. More specifically, after nutrients injection, the original dominant populations of Petrobacter and Alishewanella in the production wells almost disappeared. The expected desirable population of Pseudomonas aeruginosa, determined by enrichment experiments in laboratory, was stimulated successfully in two wells of the five monitored wells. Unexpectedly, another potential population of Pseudomonas pseudoalcaligenes which were not detected in the enrichment culture in laboratory was stimulated in the other three monitored production wells. In this study, monitoring of microbial community displayed a comprehensive alteration of microbial populations during the field trial to remedy the deficiency of culture-dependent monitoring methods. The results would help to develop and apply more MEOR processes.

Sublethal Effects of Neonicotinoid Insecticide on Calling Behavior and Pheromone Production of Tortricid Moths.

Science.gov (United States)

Navarro-Roldán, Miguel A; Gemeno, César

2017-09-01

In moths, sexual behavior combines female sex pheromone production and calling behavior. The normal functioning of these periodic events requires an intact nervous system. Neurotoxic insecticide residues in the agroecosystem could impact the normal functioning of pheromone communication through alteration of the nervous system. In this study we assess whether sublethal concentrations of the neonicotinoid insecticide thiacloprid, that competitively modulates nicotinic acetylcholine receptors at the dendrite, affect pheromone production and calling behavior in adults of three economically important tortricid moth pests; Cydia pomonella (L.), Grapholita molesta (Busck), and Lobesia botrana (Denis & Schiffermüller). Thiacloprid significantly reduced the amount of calling in C. pomonella females at LC 0.001 (a lethal concentration that kills only 1 in 10 5 individuals), and altered its calling period at LC 1 , and in both cases the effect was dose-dependent. In the other two species the effect was similar but started at higher LCs, and the effect was relatively small in L. botrana. Pheromone production was altered only in C. pomonella, with a reduction of the major compound, codlemone, and one minor component, starting at LC 10 . Since sex pheromones and neonicotinoids are used together in the management of these three species, our results could have implications regarding the interaction between these two pest control methods.

Beyond the treatment effect: Evaluating the effects of patient preferences in randomised trials.

Science.gov (United States)

Walter, S D; Turner, R; Macaskill, P; McCaffery, K J; Irwig, L

2017-02-01

The treatments under comparison in a randomised trial should ideally have equal value and acceptability - a position of equipoise - to study participants. However, it is unlikely that true equipoise exists in practice, because at least some participants may have preferences for one treatment or the other, for a variety of reasons. These preferences may be related to study outcomes, and hence affect the estimation of the treatment effect. Furthermore, the effects of preferences can sometimes be substantial, and may even be larger than the direct effect of treatment. Preference effects are of interest in their own right, but they cannot be assessed in the standard parallel group design for a randomised trial. In this paper, we describe a model to represent the impact of preferences on trial outcomes, in addition to the usual treatment effect. In particular, we describe how outcomes might differ between participants who would choose one treatment or the other, if they were free to do so. Additionally, we investigate the difference in outcomes depending on whether or not a participant receives his or her preferred treatment, which we characterise through a so-called preference effect. We then discuss several study designs that have been proposed to measure and exploit data on preferences, and which constitute alternatives to the conventional parallel group design. Based on the model framework, we determine which of the various preference effects can or cannot be estimated with each design. We also illustrate these ideas with some examples of preference designs from the literature.

Interim analysis: A rational approach of decision making in clinical trial.

Science.gov (United States)

Kumar, Amal; Chakraborty, Bhaswat S

2016-01-01

Interim analysis of especially sizeable trials keeps the decision process free of conflict of interest while considering cost, resources, and meaningfulness of the project. Whenever necessary, such interim analysis can also call for potential termination or appropriate modification in sample size, study design, and even an early declaration of success. Given the extraordinary size and complexity today, this rational approach helps to analyze and predict the outcomes of a clinical trial that incorporate what is learned during the course of a study or a clinical development program. Such approach can also fill the gap by directing the resources toward relevant and optimized clinical trials between unmet medical needs and interventions being tested currently rather than fulfilling only business and profit goals.

Interim analysis: A rational approach of decision making in clinical trial

Directory of Open Access Journals (Sweden)

Amal Kumar

2016-01-01

Full Text Available Interim analysis of especially sizeable trials keeps the decision process free of conflict of interest while considering cost, resources, and meaningfulness of the project. Whenever necessary, such interim analysis can also call for potential termination or appropriate modification in sample size, study design, and even an early declaration of success. Given the extraordinary size and complexity today, this rational approach helps to analyze and predict the outcomes of a clinical trial that incorporate what is learned during the course of a study or a clinical development program. Such approach can also fill the gap by directing the resources toward relevant and optimized clinical trials between unmet medical needs and interventions being tested currently rather than fulfilling only business and profit goals.

Impact of perioperative blood pressure variability on health resource utilization after cardiac surgery: an analysis of the ECLIPSE trials.

Science.gov (United States)

Aronson, Solomon; Levy, Jerrold H; Lumb, Philip D; Fontes, Manuel; Wang, Yamei; Crothers, Tracy A; Sulham, Katherine A; Navetta, Marco S

2014-06-01

To examine the impact of blood pressure control on hospital health resource utilization using data from the ECLIPSE trials. Post-hoc analysis of data from 3 prospective, open-label, randomized clinical trials (ECLIPSE trials). Sixty-one medical centers in the United States. Patients 18 years or older undergoing cardiac surgery. Clevidipine was compared with nitroglycerin, sodium nitroprusside, and nicardipine. The ECLIPSE trials included 3 individual randomized open-label studies comparing clevidipine to nitroglycerin, sodium nitroprusside, and nicardipine. Blood pressure control was assessed as the integral of the cumulative area under the curve (AUC) outside specified systolic blood pressure ranges, such that lower AUC represents less variability. This analysis examined surgery duration, time to extubation, as well as intensive care unit (ICU) and hospital length of stay (LOS) in patients with AUC≤10 mmHg×min/h compared to patients with AUC>10 mmHg×min/h. One thousand four hundred ten patients were included for analysis; 736 patients (52%) had an AUC≤10 mmHg×min/h, and 674 (48%) had an AUC>10 mmHg×min/h. The duration of surgery and ICU LOS were similar between groups. Time to extubation and postoperative LOS were both significantly shorter (p = 0.05 and pAUC≤10. Multivariate analysis demonstrates AUC≤10 was significantly and independently associated with decreased time to extubation (hazard ratio 1.132, p = 0.0261) and postoperative LOS (hazard ratio 1.221, p = 0.0006). Based on data derived from the ECLIPSE studies, increased perioperative BP variability is associated with delayed time to extubation and increased postoperative LOS. Copyright © 2014 Elsevier Inc. All rights reserved.

29 CFR 785.17 - On-call time.

Science.gov (United States)

2010-07-01

... On-call time. An employee who is required to remain on call on the employer's premises or so close... employee who is not required to remain on the employer's premises but is merely required to leave word at his home or with company officials where he may be reached is not working while on call. (Armour & Co...

CALLING AQUARIUM LOVERS...

CERN Multimedia

2002-01-01

CERN's anemones will soon be orphans. We are looking for someone willing to look after the aquarium in the main building, for one year. If you are interested, or if you would like more information, please call 73830. (The anemones living in the aquarium thank you in anticipation.)

Calling 911! What role does the pediatrician play?

Science.gov (United States)

Grossman, Devin; Kunkov, Sergey; Kaplan, Carl; Crain, Ellen F

2013-06-01

The objective of this study was to compare admission rates and medical interventions among children whose caregivers called their child's primary care provider (PCP) before taking an ambulance to the pediatric emergency department (PED) versus those who did not. This was a prospective cohort study of patients brought to an urban, public hospital PED via emergency medical system (EMS). Children were included if the caregiver called 911 to have them transported via EMS and was present in the PED. The main variable was whether the child's PCP was called before EMS utilization. Study outcomes were medical interventions, such as intravenous line insertion or laboratory tests, and hospital admission. χ Test and logistic regression were used to evaluate the relationship of the main variable to the study outcomes. Six hundred fourteen patients met inclusion criteria and were enrolled. Five hundred eighty-five patients (95.3%) were reported to have a PCP. Seventy-four caregivers (12.1%) called their child's PCP before calling EMS. Two hundred seventy-seven patients (45.1%) had medical interventions performed; of these, 42 (15.2%) called their PCP (P = 0.03). Forty-two patients (6.8%) were admitted; among these, 14 (33.3%) called their PCP (P < 0.01). Adjusting for triage level, patients whose caregiver called the PCP before calling EMS were 3.2 times (95% confidence interval, 1.9-5.2 times) more likely to be admitted and 1.7 times (95% confidence interval, 1.1-2.9 times) more likely to have a medical intervention compared with patients whose caregivers did not call their child's PCP. Children were more likely to be admitted or require a medical intervention if their caregiver called their PCP before calling EMS. The availability of a PCP for telephone triage may help to optimize EMS utilization.

Evaluating research and impact: a bibliometric analysis of research by the NIH/NIAID HIV/AIDS clinical trials networks.

Directory of Open Access Journals (Sweden)

Scott R Rosas

2011-03-01

Full Text Available Evaluative bibliometrics uses advanced techniques to assess the impact of scholarly work in the context of other scientific work and usually compares the relative scientific contributions of research groups or institutions. Using publications from the National Institute of Allergy and Infectious Diseases (NIAID HIV/AIDS extramural clinical trials networks, we assessed the presence, performance, and impact of papers published in 2006-2008. Through this approach, we sought to expand traditional bibliometric analyses beyond citation counts to include normative comparisons across journals and fields, visualization of co-authorship across the networks, and assess the inclusion of publications in reviews and syntheses. Specifically, we examined the research output of the networks in terms of the a presence of papers in the scientific journal hierarchy ranked on the basis of journal influence measures, b performance of publications on traditional bibliometric measures, and c impact of publications in comparisons with similar publications worldwide, adjusted for journals and fields. We also examined collaboration and interdisciplinarity across the initiative, through network analysis and modeling of co-authorship patterns. Finally, we explored the uptake of network produced publications in research reviews and syntheses. Overall, the results suggest the networks are producing highly recognized work, engaging in extensive interdisciplinary collaborations, and having an impact across several areas of HIV-related science. The strengths and limitations of the approach for evaluation and monitoring research initiatives are discussed.

U.S. Policy Responses to Calls for the Medical Use of Cannabis

Science.gov (United States)

Hall, Wayne

2015-01-01

This paper discusses the evolution of U.S. policy responses to calls to allow patients to use cannabis for medical purposes. It first summarizes the research evidence on the safety and efficacy of cannabinoids for various medical uses. It then outlines the challenges in developing new pharmaceutical cannabinoids that are safe, effective, and acceptable to patients. It briefly describes the strengths and limitations of the different ways in which U.S. states have allowed patients to use cannabis for medical purposes. These include allowing access for research trials only, allowing medical necessity as a defense against prosecution, and allowing commercial medical dispensaries to provide cannabis to approved patients. It argues that liberal definitions of indications for medical cannabis use and the commercialization of medical cannabis supply in California have produced the de facto legalization of recreational cannabis use. PMID:26339208

A cluster randomised controlled trial of a telephone-based intervention targeting the home food environment of preschoolers (The Healthy Habits Trial): the effect on parent fruit and vegetable consumption.

Science.gov (United States)

Wyse, Rebecca; Campbell, Karen J; Brennan, Leah; Wolfenden, Luke

2014-12-24

The home food environment is an important setting for the development of dietary patterns in childhood. Interventions that support parents to modify the home food environment for their children, however, may also improve parent diet. The purpose of this study was to assess the impact of a telephone-based intervention targeting the home food environment of preschool children on the fruit and vegetable consumption of parents. In 2010, 394 parents of 3-5 year-old children from 30 preschools in the Hunter region of Australia were recruited to this cluster randomised controlled trial and were randomly assigned to an intervention or control group. Intervention group parents received four weekly 30-minute telephone calls and written resources. The scripted calls focused on; fruit and vegetable availability and accessibility, parental role-modelling, and supportive home food routines. Two items from the Australian National Nutrition Survey were used to assess the average number of serves of fruit and vegetables consumed each day by parents at baseline, and 2-, 6-, 12-, and 18-months later, using generalised estimating equations (adjusted for baseline values and clustering by preschool) and an intention-to-treat-approach. At each follow-up, vegetable consumption among intervention parents significantly exceeded that of controls. At 2-months the difference was 0.71 serves (95% CI: 0.58-0.85, p food environment can increase parents' fruit and vegetable consumption. (ANZCTR12609000820202).

Sharing programming resources between Bio* projects through remote procedure call and native call stack strategies

DEFF Research Database (Denmark)

Prins, Pjotr; Goto, Naohisa; Yates, Andrew

2012-01-01

Open-source software (OSS) encourages computer programmers to reuse software components written by others. In evolutionary bioinformatics, OSS comes in a broad range of programming languages, including C/C++, Perl, Python, Ruby, Java, and R. To avoid writing the same functionality multiple times...... for different languages, it is possible to share components by bridging computer languages and Bio* projects, such as BioPerl, Biopython, BioRuby, BioJava, and R/Bioconductor. In this chapter, we compare the two principal approaches for sharing software between different programming languages: either by remote...... procedure call (RPC) or by sharing a local call stack. RPC provides a language-independent protocol over a network interface; examples are RSOAP and Rserve. The local call stack provides a between-language mapping not over the network interface, but directly in computer memory; examples are R bindings, RPy...

Indico CONFERENCE: Define the Call for Abstracts

CERN Multimedia

CERN. Geneva; Ferreira, Pedro

2017-01-01

In this tutorial, you will learn how to define and open a call for abstracts. When defining a call for abstracts, you will be able to define settings related to the type of questions asked during a review of an abstract, select the users who will review the abstracts, decide when to open the call for abstracts, and more.

Call for Research

International Development Research Centre (IDRC) Digital Library (Canada)

Marie-Isabelle Beyer

2014-10-03

Oct 3, 2014 ... 5.Submission process. 6.Eligibility criteria. 7.Selection Process. 8. Format and requirements. 9.Evaluation criteria. 10.Country clearance requirements. 11. .... It is envisaged that through this call a single consortium will undertake 6-8 projects within a total budget of up to ... principle qualify for IDRC's support.

The function of migratory bird calls

DEFF Research Database (Denmark)

Reichl, Thomas; Andersen, Bent Bach; Larsen, Ole Næsbye

The function of migratory bird calls: do they influence orientation and navigation?   Thomas Reichl1, Bent Bach Andersen2, Ole Naesbye Larsen2, Henrik Mouritsen1   1Institute of Biology, University of Oldenburg, Oldenburg, D-26111 Oldenburg, Germany 2Institute of Biology, University of Southern...... migration and to stimulate migratory restlessness in conspecifics. We wished to test if conspecific flight calls influence the flight direction of a nocturnal migrant, the European Robin (Erithacus rubecula), i.e. if flight calls help migrants keeping course. Wild caught birds showing migratory restlessness...... the experimental bird could be activated successively to simulate a migrating Robin cruising E-W, W-E, S-N or N-S at a chosen height (mostly about 40 m), at 10 m/s and emitting Robin flight calls of 80 dB(A) at 1 m. The simulated flight of a "ding" sound served as a control. During an experiment the bird was first...

An empirical analysis of the corporate call decision

International Nuclear Information System (INIS)

Carlson, M.D.

1998-01-01

An economic study of the the behaviour of financial managers of utility companies was presented. The study examined whether or not an option pricing based model of the call decision does a better job of explaining callable preferred share prices and call decisions compared to other models. In this study, the Rust (1987) empirical technique was extended to include the use of information from preferred share prices in addition to the call decisions. Reasonable estimates were obtained from data of shares of the Pacific Gas and Electric Company (PGE) for the transaction costs associated with a call. It was concluded that the managers of the PGE clearly take into account the value of the option to delay the call when making their call decisions

Perceived Calling and Work Engagement Among Nurses.

Science.gov (United States)

Ziedelis, Arunas

2018-03-01

The purpose of this study was to explore the relationship of perceived calling and work engagement in nursing over and above major work environment factors. In all, 351 nurses from various health care institutions completed the survey. Data were collected about the most demanding aspects of nursing, major job resources, the degree to which nursing is perceived as a meaningful calling, work engagement, and main demographic information. Hierarchical linear regression was applied to assess the relation between perceived calling and work engagement, while controlling for demographic and work environment factors, and perceived calling was significantly related to two out of three components of nurses' work engagement. The highest association was found with dedication component, and vigor component was related insignificantly. Results have shown that perceived calling might motivate nurses to engage in their work even in burdensome environment, although possible implications for the occupational well-being of nurses themselves remains unclear.

Data Call Response for NEPA Supplement Analysis of CMRR

Energy Technology Data Exchange (ETDEWEB)

Booth, Steven Richard [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

2015-02-01

The Department of Energy/National Nuclear Security Administration (DOE/NNSA) is proposing to provide analytical chemistry (AC) and materials characterization (MC) capabilities at the Los Alamos National Laboratory (LANL) by using a combination of existing space in two existing buildings: the Radiological Laboratory/Utility/Office Building (RLUOB) and the Plutonium Facility, Building 4 (PF-4) in TA-55. This represents a change from decisions made by DOE as informed by previous National Environmental Policy Act (NEPA) analyses. In accordance with Council on Environmental Quality (CEQ) and DOE requirements, NNSA is preparing a Supplement Analysis (SA) to evaluate the potential environmental impacts of the proposed action. The focus of this analysis is on determining whether the proposal to provide AC and MC laboratory capabilities in existing space in RLUOB and PF-4 rather than building a new nuclear facility (NF) is a substantial change that is relevant to environmental concerns or whether new circumstance or information relevant to environmental concerns and bearing on the proposed action or its impacts are significant. The end result of the analysis is a determination whether the existing Chemistry and Metallurgy Research Building Replacement Environmental Impact Statement (CMRR EIS) should be supplemented, a new EIS should be prepared, or no further NEPA analysis is necessary. This report provides data for incorporation into the Supplement Analysis being written by Leidos, Inc. under contract to NNSA. Responding to the data call requires several areas of expertise. Los Alamos subject matter experts estimate equipments lists, facility modifications, waste quantities, labor needs and radiological doses. Los Alamos NEPA experts assist Leidos in compiling existing data from the LANL Site-Wide Environmental Impact Statement (SWEIS) and CMRR EIS for public and other impacts. Bounding conditions are used to determine NEPA estimates.

On-call work and health: a review

Directory of Open Access Journals (Sweden)

Botterill Jackie S

2004-12-01

Full Text Available Abstract Many professions in the fields of engineering, aviation and medicine employ this form of scheduling. However, on-call work has received significantly less research attention than other work patterns such as shift work and overtime hours. This paper reviews the current body of peer-reviewed, published research conducted on the health effects of on-call work The health effects studies done in the area of on-call work are limited to mental health, job stress, sleep disturbances and personal safety. The reviewed research suggests that on-call work scheduling can pose a risk to health, although there are critical gaps in the literature.

Systems configured to distribute a telephone call, communication systems, communication methods and methods of routing a telephone call to a service representative

Science.gov (United States)

Harris, Scott H.; Johnson, Joel A.; Neiswanger, Jeffery R.; Twitchell, Kevin E.

2004-03-09

The present invention includes systems configured to distribute a telephone call, communication systems, communication methods and methods of routing a telephone call to a customer service representative. In one embodiment of the invention, a system configured to distribute a telephone call within a network includes a distributor adapted to connect with a telephone system, the distributor being configured to connect a telephone call using the telephone system and output the telephone call and associated data of the telephone call; and a plurality of customer service representative terminals connected with the distributor and a selected customer service representative terminal being configured to receive the telephone call and the associated data, the distributor and the selected customer service representative terminal being configured to synchronize, application of the telephone call and associated data from the distributor to the selected customer service representative terminal.

Developing an English for Specific Purpose Curriculum for Asian Call Centres: How Theory Can Inform Practice

Science.gov (United States)

Lockwood, Jane

2012-01-01

The primary focus of this article is the investigation of how current applied linguistic research into the nature of call centre communication breakdown in business processing outsourcing (BPO) sites such as India and the Philippines, can impact English communications training program content and design for this industry. It is argued that a…

No Call for Action? Why There Is No Union (Yet in Philippine Call Centers

Directory of Open Access Journals (Sweden)

Niklas Reese

2013-01-01

Full Text Available This contribution presents findings from a qualitative study which focused on young urban professionals in the Philippines who work(ed in international call centers – workplaces usually characterized by job insecurity and other forms of precarity, factory-like working conditions, and disembeddedness. Nevertheless, trade unions in these centers have not come into existence. Why collective action is not chosen by call center agents as an option to tackle the above mentioned problems – this is what the research project this article is based on tried to understand. After outlining some workrelated problems identified by Filipino call center agents, the article will focus on the strategies the agents employ to counter these problems (mainly accommodation and everyday resistance. By highlighting five objective and five subjective reasons (or reasons by circumstances and reasons by framing, we conclude that it is not repressive regulation policies, but rather the formative power and the internalization of discourses of rule within individual life strategies that are preventing the establishment of unions and other collective action structures.

Impact of pregabalin on the occurrence of postthoracotomy pain syndrome: a randomized trial.

Science.gov (United States)

Brulotte, Véronique; Ruel, Monique M; Lafontaine, Edwin; Chouinard, Philippe; Girard, François

2015-01-01

Postthoracotomy pain syndrome (PTPS) is a frequent cause of chronic postoperative pain. Pregabalin might reduce the incidence of chronic postoperative pain. The goal of this study was to evaluate the impact of perioperative pregabalin on the occurrence of PTPS, defined as any surgical site pain 3 months after surgery. We conducted a randomized, placebo-controlled, double-blind trial in patients undergoing elective thoracotomy. Patients received either pregabalin 150 mg orally twice a day initiated 1 hour before thoracotomy and continued until 4 days after thoracotomy (10 doses total) or a placebo using the same protocol. All patients received preincision thoracic epidural analgesia. Postthoracotomy pain syndrome was evaluated using the Brief Pain Inventory questionnaire through a telephone interview. Secondary outcomes included evaluation of neuropathic characteristics through the Leeds Assessment of Neuropathic Symptoms and Signs questionnaire, analgesic use 3 months after surgery, and evaluation of acute postoperative pain and opioid consumption. One hundred fourteen patients were randomized, and 99 patients completed the study (placebo, n = 49; pregabalin, n = 50). Postthoracotomy pain syndrome occurred in 49 (49.5%) of 99 patients and more frequently in the pregabalin group (31/50 [62%] vs 18/49 [37%] in the placebo group, P = 0.01). However, among patients with PTPS, those in the pregabalin group required significantly less analgesics, reported less moderate to severe average pain, and presented significantly less neuropathic characteristics than patients in the placebo group 3 months after surgery. Pregabalin did not reduce the incidence of PTPS in this study. Future research on PTPS should focus on the impact of regional analgesia on central sensitization.

Rationale, design and methods for a randomised and controlled trial of the impact of virtual reality games on motor competence, physical activity, and mental health in children with developmental coordination disorder

Directory of Open Access Journals (Sweden)

Straker Leon M

2011-08-01

Full Text Available Abstract Background A healthy start to life requires adequate motor development and physical activity participation. Currently 5-15% of children have impaired motor development without any obvious disorder. These children are at greater risk of obesity, musculoskeletal disorders, low social confidence and poor mental health. Traditional electronic game use may impact on motor development and physical activity creating a vicious cycle. However new virtual reality (VR game interfaces may provide motor experiences that enhance motor development and lead to an increase in motor coordination and better physical activity and mental health outcomes. VR games are beginning to be used for rehabilitation, however there is no reported trial of the impact of these games on motor coordination in children with developmental coordination disorder. Methods This cross-over randomised and controlled trial will examine whether motor coordination is enhanced by access to active electronic games and whether daily activity, attitudes to physical activity and mental health are also enhanced. Thirty children aged 10-12 years with poor motor coordination (≤ 15th percentile will be recruited and randomised to a balanced ordering of 'no active electronic games' and 'active electronic games'. Each child will participate in both conditions for 16 weeks, and be assessed prior to participation and at the end of each condition. The primary outcome is motor coordination, assessed by kinematic and kinetic motion analysis laboratory measures. Physical activity and sedentary behaviour will be assessed by accelerometry, coordination in daily life by parent report questionnaire and attitudes to physical activity, self-confidence, anxiety and depressed mood will be assessed by self report questionnaire. A sample of 30 will provide a power of > 0.9 for detecting a 5 point difference in motor coordination on the MABC-2 TIS scale (mean 17, sd = 5. Discussion This is the first trial to

The impact of insecticide-treated school uniforms on dengue infections in school-aged children: study protocol for a randomised controlled trial in Thailand.

Science.gov (United States)

Wilder-Smith, Annelies; Byass, Peter; Olanratmanee, Phanthip; Maskhao, Pongsri; Sringernyuang, Luechai; Logan, James G; Lindsay, Steve W; Banks, Sarah; Gubler, Duane; Louis, Valérie R; Tozan, Yesim; Kittayapong, Pattamaporn

2012-11-15

There is an urgent need to protect children against dengue since this age group is particularly sensitive to the disease. Since dengue vectors are active mainly during the day, a potential target for control should be schools where children spend a considerable amount of their day. School uniforms are the cultural norm in most developing countries, worn throughout the day. We hypothesise that insecticide-treated school uniforms will reduce the incidence of dengue infection in school-aged children. Our objective is to determine the impact of impregnated school uniforms on dengue incidence. A randomised controlled trial will be conducted in eastern Thailand in a group of schools with approximately 2,000 students aged 7-18 years. Pre-fabricated school uniforms will be commercially treated to ensure consistent, high-quality insecticide impregnation with permethrin. A double-blind, randomised, crossover trial at the school level will cover two dengue transmission seasons. Practical issues and plans concerning intervention implementation, evaluation, analysing and interpreting the data, and possible policy implications arising from the trial are discussed. clinicaltrial.gov. NCT01563640.

Healthy eating and obesity prevention for preschoolers: a randomised controlled trial

Directory of Open Access Journals (Sweden)

Swinburn Boyd

2010-04-01

Full Text Available Abstract Background Developing effective prevention and intervention programs for the formative preschool years is seen as an essential step in combating the obesity epidemic across the lifespan. The overall goal of the current project is to measure the effectiveness of a healthy eating and childhood obesity prevention intervention, the MEND (Mind Exercise Nutrition Do It! program that is delivered to parents of children aged 2-4 years. Methods/Design This randomised controlled trial will be conducted with 200 parents and their 2-4 year old children who attend the MEND 2-4 program in metropolitan and regional Victoria. Parent-child dyads will attend ten 90-minute group workshops. These workshops focus on general nutrition, as well as physical activity and behaviours. They are typically held at community or maternal and child health centres and run by a MEND 2-4 trained program leader. Child eating habits, physical activity levels and parental behaviours and cognitions pertaining to nutrition and physical activity will be assessed at baseline, the end of the intervention, and at 6 and 12 months post the intervention. Informed consent will be obtained from all parents, who will then be randomly allocated to the intervention or wait-list control group. Discussion Our study is the first RCT of a healthy eating and childhood obesity prevention intervention targeted specifically to Australian parents and their preschool children aged 2-4 years. It responds to the call by experts in the area of childhood obesity and child health that prevention of overweight in the formative preschool years should focus on parents, given that parental beliefs, attitudes, perceptions and behaviours appear to impact significantly on the development of early overweight. This is 'solution-oriented' rather than 'problem-oriented' research, with its focus being on prevention rather than intervention. If this is a positive trial, the MEND2-4 program can be implemented as a

Long-term biological and behavioural impact of an adolescent sexual health intervention in Tanzania: follow-up survey of the community-based MEMA kwa Vijana Trial.

Directory of Open Access Journals (Sweden)

Aoife M Doyle

2010-06-01

Full Text Available The ability of specific behaviour-change interventions to reduce HIV infection in young people remains questionable. Since January 1999, an adolescent sexual and reproductive health (SRH intervention has been implemented in ten randomly chosen intervention communities in rural Tanzania, within a community randomised trial (see below; NCT00248469. The intervention consisted of teacher-led, peer-assisted in-school education, youth-friendly health services, community activities, and youth condom promotion and distribution. Process evaluation in 1999-2002 showed high intervention quality and coverage. A 2001/2 intervention impact evaluation showed no impact on the primary outcomes of HIV seroincidence and herpes simplex virus type 2 (HSV-2 seroprevalence but found substantial improvements in SRH knowledge, reported attitudes, and some reported sexual behaviours. It was postulated that the impact on "upstream" knowledge, attitude, and reported behaviour outcomes seen at the 3-year follow-up would, in the longer term, lead to a reduction in HIV and HSV-2 infection rates and other biological outcomes. A further impact evaluation survey in 2007/8 ( approximately 9 years post-intervention tested this hypothesis.This is a cross-sectional survey (June 2007 through July 2008 of 13,814 young people aged 15-30 y who had attended trial schools during the first phase of the MEMA kwa Vijana intervention trial (1999-2002. Prevalences of the primary outcomes HIV and HSV-2 were 1.8% and 25.9% in males and 4.0% and 41.4% in females, respectively. The intervention did not significantly reduce risk of HIV (males adjusted prevalence ratio [aPR] 0.91, 95%CI 0.50-1.65; females aPR 1.07, 95%CI 0.68-1.67 or HSV-2 (males aPR 0.94, 95%CI 0.77-1.15; females aPR 0.96, 95%CI 0.87-1.06. The intervention was associated with a reduction in the proportion of males reporting more than four sexual partners in their lifetime (aPR 0.87, 95%CI 0.78-0.97 and an increase in reported

Impact of hydroxyurea on clinical events in the BABY HUG trial

Science.gov (United States)

Files, Beatrice A.; Luo, Zhaoyu; Miller, Scott T.; Kalpatthi, Ram; Iyer, Rathi; Seaman, Phillip; Lebensburger, Jeffrey; Alvarez, Ofelia; Thompson, Bruce; Ware, Russell E.; Wang, Winfred C.

2012-01-01

The Pediatric Hydroxyurea Phase 3 Clinical Trial (BABY HUG) was a phase 3 multicenter, randomized, double-blind, placebo-controlled clinical trial of hydroxyurea in infants (beginning at 9-18 months of age) with sickle cell anemia. An important secondary objective of this study was to compare clinical events between the hydroxyurea and placebo groups. One hundred and ninety-three subjects were randomized to hydroxyurea (20 mg/kg/d) or placebo; there were 374 patient-years of on-study observation. Hydroxyurea was associated with statistically significantly lower rates of initial and recurrent episodes of pain, dactylitis, acute chest syndrome, and hospitalization; even infants who were asymptomatic at enrollment had less dactylitis as well as fewer hospitalizations and transfusions if treated with hydroxyurea. Despite expected mild myelosuppression, hydroxyurea was not associated with an increased risk of bacteremia or serious infection. These data provide important safety and efficacy information for clinicians considering hydroxyurea therapy for very young children with sickle cell anemia. This clinical trial is registered with the National Institutes of Health (NCT00006400, www.clinicaltrials.gov). PMID:22915643

Extension Trial of Qigong for Fibromyalgia: A Quantitative and Qualitative Study

Directory of Open Access Journals (Sweden)

Jana Sawynok

2013-01-01

Full Text Available This extension trial is an open-label observational trial of 20 subjects with fibromyalgia who undertook level 2 Chaoyi Fanhuan Qigong (CFQ training following an earlier controlled trial of level 1 CFQ. Subjects practiced 60 min/day for 8 weeks and continued some daily practice for 6 months. Quantitative measures, assessed at baseline, 8 weeks, 4 and 6 months, were of pain, impact, sleep, physical and mental functions, and practice time. Qualitative comments also were recorded. Compared to baselines, CFQ practice led to significant improvements in pain, impact, sleep, and physical function in the 13 subjects (65% who completed the trial; changes were present at 8 weeks and were maintained for the 6-month trial duration. A highly motivated subgroup of N=5, who practiced the most, had the best outcomes in terms of end symptomology, and qualitative comments indicated health benefits in other domains as well. Qualitative comments by the remaining N=8 trial completers and N=7 withdrawals indicate different experiences with the practice. This extension trial indicates that diligent CFQ practice over time produces significant health gains in fibromyalgia in a subset of individuals. Future studies will need to address factors that might predispose to favourable outcomes.

A qualitative content analysis of peer mentoring video calls in adolescents with chronic illness.

Science.gov (United States)

Ahola Kohut, Sara; Stinson, Jennifer; Forgeron, Paula; van Wyk, Margaret; Harris, Lauren; Luca, Stephanie

2018-05-01

This article endeavored to determine the topics of discussion during open-ended peer mentoring between adolescents and young adults living with chronic illness. This study occurred alongside a study of the iPeer2Peer Program. Fifty-two calls (7 mentor-mentee pairings) were audio recorded, transcribed verbatim, and analyzed using inductive coding with an additional 30 calls (21 mentor-mentee pairings) coded to ensure representativeness of the data. Three categories emerged: (1) illness impact (e.g., relationships, school/work, self-identity, personal stories), (2) self-management (e.g., treatment adherence, transition to adult care, coping strategies), and (3) non-illness-related adolescent issues (e.g., post-secondary goals, hobbies, social environments). Differences in discussed topics were noted between sexes and by diagnosis. Peer mentors provided informational, appraisal, and emotional support to adolescents.

Try it, you’ll like it—or will you? : The perils of early free-trial promotions for high-tech service adoption

NARCIS (Netherlands)

Foubert, B.; Gijsbrechts, Els

The proliferation of free trials for high-tech services calls for a careful study of their effectiveness, and the drivers thereof. On the one hand, free trials can generate new paying subscribers, by allowing consumers to become acquainted with the service free of charge. On the other hand, a

Effectiveness of the Call in Beach Volleyball Attacking Play

Directory of Open Access Journals (Sweden)

Künzell Stefan

2014-12-01

Full Text Available In beach volleyball the setter has the opportunity to give her or his hitter a “call”. The call intends that the setter suggests to her or his partner where to place the attack in the opponent’s court. The effectiveness of a call is still unknown. We investigated the women’s and men’s Swiss National Beach Volleyball Championships in 2011 and analyzed 2185 attacks. We found large differences between female and male players. While men called in only 38.4% of attacks, women used calls in 85.5% of attacks. If the male players followed a given call, 63% of the attacks were successful. The success rate of attacks without any call was 55.8% and 47.6% when the call was ignored. These differences were not significant (χ2(2 = 4.55, p = 0.103. In women’s beach volleyball, the rate of successful attacks was 61.5% when a call was followed, 35% for attacks without a call, and 42.6% when a call was ignored. The differences were highly significant (χ2(2 = 23.42, p < 0.0005. Taking into account the findings of the present study, we suggested that the call was effective in women’s beach volleyball, while its effect in men’s game was unclear. Considering the quality of calls we indicate that there is a significant potential to increase the effectiveness of a call.

Use of a multi-process phytoremediation system for decontamination of petroleum impacted soils : results of successful field trials

International Nuclear Information System (INIS)

Greenberg, B.M.; Gurska, J.; Huang, X.D.; Gerhardt, K.E.; Yu, X.M.; Nykamp, J.; MacNeill, G.; Yang, S.; Lu, X.; Glick, B.; Wang, W.; Knezevich, N.; Reid, N.

2008-01-01

The multi-process phytoremediation system (MPPS) was developed to degrade petroleum hydrocarbons (PHCs) in impacted soils. Phytoremediation of persistent contaminants in soils holds significant promise for rapid remediation kinetics. MPPS effectively removes polycyclic aromatic hydrocarbons (PAHs), total petroleum hydrocarbons (TPHs) and chlorinated hydrocarbons (CHCs) from soils. A plant growth promoting rhizobacteria interaction is the main element for success as it mitigates stress ethylene effects in plants, leading to high root biomass which, in turn, promotes growth of rhizosphere organisms. Field tests of the MPPS were initiated at a farm site in Sarnia, Ontario in the summer of 2004. The field was contaminated with petroleum hydrocarbons from refinery oil sludge. The second field trial was performed for 3 consecutive years at a petroleum contaminated biopile in Turner Valley, Alberta. The paper presented the results of the successful field tests of the MPPS. It was concluded that increased root biomass is achieved in the contaminated soils, which leads to more efficient and complete removal of TPHs in the field. Three years of field trials of the MPPS showed that remediation continues with successive seasons. 28 refs., 1 tab., 3 figs

The impact of radiologists' expertise on screen results decisions in a CT lung cancer screening trial

Energy Technology Data Exchange (ETDEWEB)

Heuvelmans, Marjolein A.; Vliegenthart, Rozemarijn [University of Groningen, University Medical Center Groningen, Center for Medical Imaging - North East Netherlands, Groningen (Netherlands); University of Groningen / University Medical Center Groningen, Department of Radiology, Groningen (Netherlands); Oudkerk, Matthijs [University of Groningen, University Medical Center Groningen, Center for Medical Imaging - North East Netherlands, Groningen (Netherlands); Jong, Pim A. de; Mali, Willem P. [University Medical Center Utrecht, Department of Radiology, Utrecht (Netherlands); Groen, Harry J.M. [University of Groningen, University Medical Center Groningen, Department of Pulmonology, Groningen (Netherlands)

2014-11-04

To evaluate the impact of radiological expertise on screen result decisions in a CT lung cancer screening trial. In the NELSON lung cancer screening trial, the baseline CT result was based on the largest lung nodule's volume. The protocol allowed radiologists to manually adjust screen results in cases of high suspicion of benign or malignant nodule nature. Participants whose baseline CT result was based on a solid or part-solid nodule were included in this study. Adjustments by radiologists at baseline were evaluated. Histology was the reference for diagnosis or to confirm benignity and stability on subsequent CT examinations. A total of 3,318 participants (2,796 male, median age 58.0 years) were included. In 195 participants (5.9 %) the initial baseline screen result was adjusted by the radiologist. Adjustment was downwards from positive or indeterminate to negative in two and 119 participants, respectively, and from positive to indeterminate in 65 participants. None of these nodules turned out to be malignant. In 9/195 participants (4.6 %) the screen result was adjusted upwards from negative to indeterminate or indeterminate to positive; two nodules were malignant. In one in 20 cases of baseline lung cancer screening, nodules were reclassified by the radiologist, leading to a reduction of false-positive screen results. (orig.)

Call for volunteers

CERN Document Server

2008-01-01

CERN is calling for volunteers from all members of the Laboratory for organizing the two exceptional Open days.CERN is calling for volunteers from all members of the Laboratory’s personnel to help with the organisation of these two exceptional Open Days, for the visits of CERN personnel and their families on the Saturday and above all for the major public Open Day on the Sunday. As for the 50th anniversary in 2004, the success of the Open Days will depend on a large number of volunteers. All those working for CERN as well as retired members of the personnel can contribute to making this event a success. Many guides will be needed at the LHC points, for the activities at the surface and to man the reception and information points. The aim of these major Open Days is to give the local populations the opportunity to discover the fruits of almost 20 years of work carried out at CERN. We are hoping for some 2000 volunteers for the two Open Days, on the Saturday from 9 a.m. to ...

Meditation-induced cognitive-control states regulate response-conflict adaptation: Evidence from trial-to-trial adjustments in the Simon task.

Science.gov (United States)

Colzato, Lorenza S; Sellaro, Roberta; Samara, Iliana; Hommel, Bernhard

2015-09-01

Here we consider the possibility that meditation has an immediate impact on information processing. Moreover, we were interested to see whether this impact affects attentional input control, as previous observations suggest, or the handling of response conflict. Healthy adults underwent a brief single session of either focused attention meditation (FAM), which is assumed to increase top-down control, or open monitoring meditation (OMM), which is assumed to weaken top-down control, before performing a Simon task-which assesses conflict-resolution efficiency. While the size of the Simon effect (reflecting the efficiency of handling response conflict) was unaffected by type of meditation, the amount of dynamic behavioral adjustments (i.e., trial-to-trial variability of the Simon effect: the Gratton effect) was considerably smaller after OMM than after FAM. Our findings suggest that engaging in meditation instantly creates a cognitive-control state that has a specific impact on conflict-driven control adaptations. Copyright © 2015 Elsevier Inc. All rights reserved.

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

Directory of Open Access Journals (Sweden)

Jordi Adamuz

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

Reporting funding source or conflict of interest in abstracts of randomized controlled trials, no evidence of a large impact on general practitioners' confidence in conclusions, a three-arm randomized controlled trial.

Science.gov (United States)

Buffel du Vaure, Céline; Boutron, Isabelle; Perrodeau, Elodie; Ravaud, Philippe

2014-04-28

Systematic reporting of funding sources is recommended in the CONSORT Statement for abstracts. However, no specific recommendation is related to the reporting of conflicts of interest (CoI). The objective was to compare physicians' confidence in the conclusions of abstracts of randomized controlled trials of pharmaceutical treatment indexed in PubMed. We planned a three-arm parallel-group randomized trial. French general practitioners (GPs) were invited to participate and were blinded to the study's aim. We used a representative sample of 75 abstracts of pharmaceutical industry-funded randomized controlled trials published in 2010 and indexed in PubMed. Each abstract was standardized and reported in three formats: 1) no mention of the funding source or CoI; 2) reporting the funding source only; and 3) reporting the funding source and CoI. GPs were randomized according to a computerized randomization on a secure Internet system at a 1:1:1 ratio to assess one abstract among the three formats. The primary outcome was GPs' confidence in the abstract conclusions (0, not at all, to 10, completely confident). The study was planned to detect a large difference with an effect size of 0.5. Between October 2012 and June 2013, among 605 GPs contacted, 354 were randomized, 118 for each type of abstract. The mean difference (95% confidence interval) in GPs' confidence in abstract findings was 0.2 (-0.6; 1.0) (P = 0.84) for abstracts reporting the funding source only versus no funding source or CoI; -0.4 (-1.3; 0.4) (P = 0.39) for abstracts reporting the funding source and CoI versus no funding source and CoI; and -0.6 (-1.5; 0.2) (P = 0.15) for abstracts reporting the funding source and CoI versus the funding source only. We found no evidence of a large impact of trial report abstracts mentioning funding sources or CoI on GPs' confidence in the conclusions of the abstracts. ClinicalTrials.gov identifier: NCT01679873.

A Randomized Trial to Determine the Impact of an Educational Patient Hand-Hygiene Intervention on Contamination of Hospitalized Patient's Hands with Healthcare-Associated Pathogens.

Science.gov (United States)

Sunkesula, Venkata C K; Kundrapu, Sirisha; Knighton, Shanina; Cadnum, Jennifer L; Donskey, Curtis J

2017-05-01

We conducted a non-blinded randomized trial to determine the impact of a patient hand-hygiene intervention on contamination of hospitalized patients' hands with healthcare-associated pathogens. Among patients with negative hand cultures on admission, recovery of pathogens from hands was significantly reduced in those receiving the intervention versus those receiving standard care. Infect Control Hosp Epidemiol 2017;38:595-597.

Perpetual Cancellable American Call Option

OpenAIRE

Emmerling, Thomas J.

2010-01-01

This paper examines the valuation of a generalized American-style option known as a Game-style call option in an infinite time horizon setting. The specifications of this contract allow the writer to terminate the call option at any point in time for a fixed penalty amount paid directly to the holder. Valuation of a perpetual Game-style put option was addressed by Kyprianou (2004) in a Black-Scholes setting on a non-dividend paying asset. Here, we undertake a similar analysis for the perpetua...

Perioperative hyperoxia - Long-term impact on cardiovascular complications after abdominal surgery, a post hoc analysis of the PROXI trial

DEFF Research Database (Denmark)

Fonnes, Siv; Gogenur, Ismail; Sondergaard, Edith Smed

2016-01-01

BACKGROUND: Increased long-term mortality was found in patients exposed to perioperative hyperoxia in the PROXI trial, where patients undergoing laparotomy were randomised to 80% versus 30% oxygen during and after surgery. This post hoc follow-up study assessed the impact of perioperative hyperoxia...... included myocardial infarction, other heart disease, and acute coronary syndrome or death. Data were analysed in the Cox proportional hazards model. RESULTS: The primary outcome, acute coronary syndrome, occurred in 2.5% versus 1.3% in the 80% versus 30% oxygen group; HR 2.15 (95% CI 0.96-4.84). Patients...

The TrialsTracker: Automated ongoing monitoring of failure to share clinical trial results by all major companies and research institutions.

Science.gov (United States)

Powell-Smith, Anna; Goldacre, Ben

2016-01-01

Background : Failure to publish trial results is a prevalent ethical breach with a negative impact on patient care. Audit is an important tool for quality improvement. We set out to produce an online resource that automatically identifies the sponsors with the best and worst record for failing to share trial results. Methods: A tool was produced that identifies all completed trials from clinicaltrials.gov, searches for results in the clinicaltrials.gov registry and on PubMed, and presents summary statistics for each sponsor online. Results : The TrialsTracker tool is now available. Results are consistent with previous publication bias cohort studies using manual searches. The prevalence of missing studies is presented for various classes of sponsor. All code and data is shared. Discussion: We have designed, built, and launched an easily accessible online service, the TrialsTracker, that identifies sponsors who have failed in their duty to make results of clinical trials available, and which can be maintained at low cost. Sponsors who wish to improve their performance metrics in this tool can do so by publishing the results of their trials.

Smart Grid Technology and Consumer Call Center Readiness

OpenAIRE

Schamber, Kelsey L.

2010-01-01

The following reasearch project deals with utility call center readiness to address customer concerns and questions about the Smart Grid and smart meter technology. Since consumer engagement is important for the benefits of the Smart Grid to be realized, the readiness and ability of utilities to answer consumer questions is an important issue. Assessing the readiness of utility call centers to address pertinant customer concerns was accomplished by calling utility call centers with Smart Grid...

Adaptive trials for tuberculosis: early reflections on theory and practice.

Science.gov (United States)

Montgomery, C M

2016-08-01

Adaptive designs (ADs) have been proposed for anti-tuberculosis treatment trials. This call for innovation occurs against the backdrop of fundamental changes in the acceptable evidence base in anti-tuberculosis treatment. To contextualise ADs for tuberculosis (TB) and explore early responses from those working in the field. In this qualitative study investigating processes of theoretical and practical change in randomised controlled trials, 24 interviews were conducted with professionals involved in AD trials, half of whom worked in the TB field. Clinical trialists working on AD trials in TB are positive about the efficiency these designs offer, but remain cautious about their suitability. In addition to technical concerns, informants discussed the challenges of implementing AD in developing countries, including limited regulatory capacity to evaluate proposals, investments needed in infrastructure and site capacity, and challenges regarding informed consent. Respondents identified funding, interdisciplinary communication and regulatory and policy responses as additional concerns potentially affecting the success of AD for TB. Empirical research is needed into patient experiences of AD, including informed consent. Further consideration of the contexts of innovation in trial design is needed. These are fundamental to the successful translation of theory into practice.

impact of queuing on call c queuing on call c queuing on call

African Journals Online (AJOL)

eobe

Corresponding Author. Tel: +234 ... variations of queuing theory deployed in G modelling include prioritized ... iques aimed at delivering solutions on the issue of optimization of GSM ne approach to ..... Principles and Practice. Upper Saddle ...

Mobile telephones: a comparison of radiated power between 3G VoIP calls and 3G VoCS calls.

Science.gov (United States)

Jovanovic, Dragan; Bragard, Guillaume; Picard, Dominique; Chauvin, Sébastien

2015-01-01

The purpose of this study is to assess the mean RF power radiated by mobile telephones during voice calls in 3G VoIP (Voice over Internet Protocol) using an application well known to mobile Internet users, and to compare it with the mean power radiated during voice calls in 3G VoCS (Voice over Circuit Switch) on a traditional network. Knowing that the specific absorption rate (SAR) is proportional to the mean radiated power, the user's exposure could be clearly identified at the same time. Three 3G (High Speed Packet Access) smartphones from three different manufacturers, all dual-band for GSM (900 MHz, 1800 MHz) and dual-band for UMTS (900 MHz, 1950 MHz), were used between 28 July and 04 August 2011 in Paris (France) to make 220 two-minute calls on a mobile telephone network with national coverage. The places where the calls were made were selected in such a way as to describe the whole range of usage situations of the mobile telephone. The measuring equipment, called "SYRPOM", recorded the radiation power levels and the frequency bands used during the calls with a sampling rate of 20,000 per second. In the framework of this study, the mean normalised power radiated by a telephone in 3G VoIP calls was evaluated at 0.75% maximum power of the smartphone, compared with 0.22% in 3G VoCS calls. The very low average power levels associated with use of 3G devices with VoIP or VoCS support the view that RF exposure resulting from their use is far from exceeding the basic restrictions of current exposure limits in terms of SAR.

A study on call/contact centers' inbound and outbound management process in Mexico

Directory of Open Access Journals (Sweden)

Luis Felipe Llanos Reynoso

2016-12-01

Full Text Available One challenge related to contact center management involves determining which process best serves customers, inbound or outbound. Such decisions impact the number of service agents available for operations, affecting costs. The size of the call centers market worldwide is estimated to reach $337 billion dollars by 2018. This industry employs 670,000 people in Mexico. A series of equations for calculating the difference in the number of service agents required by the two processes is determined using the direct demo method. Developed theorems and corollary may help simplify decision-making processes. The findings demonstrate that the number of agents required for both processes depends on the percentage of customers served at each location and on service agent occupation rates. The study recommends some best practices to the Mexican call center industry in order to improve its profits and quality within the inbound outbound services.

Patients on weaning trials classified with support vector machines

International Nuclear Information System (INIS)

Garde, Ainara; Caminal, Pere; Giraldo, Beatriz F; Schroeder, Rico; Voss, Andreas; Benito, Salvador

2010-01-01

The process of discontinuing mechanical ventilation is called weaning and is one of the most challenging problems in intensive care. An unnecessary delay in the discontinuation process and an early weaning trial are undesirable. This study aims to characterize the respiratory pattern through features that permit the identification of patients' conditions in weaning trials. Three groups of patients have been considered: 94 patients with successful weaning trials, who could maintain spontaneous breathing after 48 h (GSucc); 39 patients who failed the weaning trial (GFail) and 21 patients who had successful weaning trials, but required reintubation in less than 48 h (GRein). Patients are characterized by their cardiorespiratory interactions, which are described by joint symbolic dynamics (JSD) applied to the cardiac interbeat and breath durations. The most discriminating features in the classification of the different groups of patients (GSucc, GFail and GRein) are identified by support vector machines (SVMs). The SVM-based feature selection algorithm has an accuracy of 81% in classifying GSucc versus the rest of the patients, 83% in classifying GRein versus GSucc patients and 81% in classifying GRein versus the rest of the patients. Moreover, a good balance between sensitivity and specificity is achieved in all classifications

Craving Ravens: Individual ‘haa’ Call Rates at Feeding Sites as Cues to Personality and Levels of Fission-Fusion Dynamics?

Directory of Open Access Journals (Sweden)

Georgine Szipl

2014-08-01

Full Text Available Common ravens aggregate in large non-breeder flocks for roosting and foraging until they achieve the status of territorial breeders. When discovering food, they produce far-reaching yells or ‘haa’ calls, which attract conspecifics. Due to the high levels of fission-fusion dynamics in non-breeders’ flocks, assemblies of feeding ravens were long thought to represent anonymous aggregations. Yet, non-breeders vary in their degree of vagrancy, and ‘haa’ calls convey individually distinct acoustic features, which are perceived by conspecifics. These findings give rise to the assumption that raven societies are based on differential social relationships on an individual level. We investigated the occurrence of ‘haa’ calling and individual call rates in a group of individually marked free-ranging ravens. Calling mainly occurred in subadult and adult females, which showed low levels of vagrancy. Call rates differed significantly between individuals and with residency status, and were correlated with calling frequency and landing frequency. Local ravens called more often and at higher rates, and were less likely to land at the feeding site than vagrant birds. The results are discussed with respect to individual degrees of vagrancy, which may have an impact on social knowledge and communication in this species.

The Wireless Nursing Call System

DEFF Research Database (Denmark)

Jensen, Casper Bruun

2006-01-01

This paper discusses a research project in which social scientists were involved both as analysts and supporters during a pilot with a new wireless nursing call system. The case thus exemplifies an attempt to participate in developing dependable health care systems and offers insight into the cha......This paper discusses a research project in which social scientists were involved both as analysts and supporters during a pilot with a new wireless nursing call system. The case thus exemplifies an attempt to participate in developing dependable health care systems and offers insight...

Integrating heterogeneous healthcare call centers.

Science.gov (United States)

Peschel, K M; Reed, W C; Salter, K

1998-01-01

In a relatively short period, OHS has absorbed multiple call centers supporting different LOBs from various acquisitions, functioning with diverse standards, processes, and technologies. However, customer and employee satisfaction is predicated on OHS's ability to thoroughly integrate these heterogeneous call centers. The integration was initiated and has successfully progressed through a balanced program of focused leadership and a defined strategy which includes site consolidation, sound performance management philosophies, and enabling technology. Benefits have already been achieved with even more substantive ones to occur as the integration continues to evolve.

Medical Decisions of Pediatric Residents Turn Riskier after a 24-Hour Call with No Sleep.

Science.gov (United States)

Aran, Adi; Wasserteil, Netanel; Gross, Itai; Mendlovic, Joseph; Pollak, Yehuda

2017-01-01

Despite a gradual reduction in the workload during residency, 24-hour calls are still an integral part of most training programs. While sleep deprivation increases the risk propensity, the impact on medical risk taking has not been studied. This study aimed to assess the clinical decision making and psychomotor performance of pediatric residents following a limited nap time during a 24-hour call. A neurocognitive battery (IntegNeuro) and a medical decision questionnaire were completed by 44 pediatric residents at 2 time points: after a 24-hour call and following 3 nights with no calls (sleep ≥5 hours). To monitor sleep, residents wore actigraphs and completed sleep logs. Nap time during the shift was change in risk taking) or 2 to 3 hours (4% decreased risk taking) (difference between groups, P = 0.001). Risk-taking tendency inversely correlated with sustained attention scores (Pearson = -0.433, P = 0.003). Sustained attention was the neurocognitive domain most affected by sleep deprivation (effect size = 0.29, P = 0.025). This study suggests that residents napping less than an hour during a night shift are prone to riskier clinical decisions. Hence, enabling residents to nap at least 1 hour during shifts is recommended. © The Author(s) 2016.

Impact of Postapproval Evidence Generation on the Biopharmaceutical Industry.

Science.gov (United States)

Milne, Christopher-Paul; Cohen, Joshua P; Felix, Abigail; Chakravarthy, Ranjana

2015-08-01

Meeting marketplace demands for proving the value of new products requires more data than the industry has routinely produced. These data include evidence from comparative effectiveness research (CER), including randomized, controlled trials; pragmatic clinical trials; observational studies; and meta-analyses. We designed and conducted a survey to examine the industry's perceptions on new data requirements regarding CER evidence, the acceptability of postapproval study types, payer-specific issues related to CER, communication of data being generated postapproval, and methods used for facilitating postapproval evidence generation. CER is being used by payers for most types of postapproval decisions. Randomized, controlled trials were indicated as the most acceptable form of evidence. At the same time, there was support for the utility of other types of studies, such as pragmatic clinical trials and observational studies. Respondents indicated the use of multiple formats for communicating postapproval data with many different stakeholders including regulators, payers, providers, and patients. Risk-sharing agreements with payers were unanimously supported by respondents with regard to certain products with unclear clinical and economic outcomes at launch. In these instances, conditional reimbursement through coverage with evidence development was considered a constructive option. The Food and Drug Administration's initiative called Regulatory Science was considered by the respondents as having the most impact on streamlining the generation of postapproval research-related evidence. The biopharmaceutical industry is faced with a broad and complex set of challenges related to evidence generation for postapproval decisions by a variety of health care system stakeholders. Uncertainty remains as to how the industry and payers use postapproval studies to guide decision making with regard to pricing and reimbursement status. Correspondingly, there is uncertainty regarding

The renewal of hydroelectric concessions in competitive call

International Nuclear Information System (INIS)

2013-01-01

This document discusses various issues associated with the planned competitive call on the French hydraulic power plants. The principles of this competitive call for hydroelectric concessions are first addressed: administrative regime of concessions, competitive call process, criteria of selection of the concession holder, case of 'concession of valleys', potential competitors. It outlines and discusses the difficulties of this competitive call: France is the single country to implement this procedure; it concerns a national asset; it questions the guarantee of a future use of equipment at best for the energy benefits of French consumers; the competitive call is a nice idea indeed but extremely complex. A note discusses the profitability aspects of Plants for Transfer of Energy by Pumping

Preliminary evaluation of factors associated with premature trial closure and feasibility of accrual benchmarks in phase III oncology trials.

Science.gov (United States)

Schroen, Anneke T; Petroni, Gina R; Wang, Hongkun; Gray, Robert; Wang, Xiaofei F; Cronin, Walter; Sargent, Daniel J; Benedetti, Jacqueline; Wickerham, Donald L; Djulbegovic, Benjamin; Slingluff, Craig L

2010-08-01

A major challenge for randomized phase III oncology trials is the frequent low rates of patient enrollment, resulting in high rates of premature closure due to insufficient accrual. We conducted a pilot study to determine the extent of trial closure due to poor accrual, feasibility of identifying trial factors associated with sufficient accrual, impact of redesign strategies on trial accrual, and accrual benchmarks designating high failure risk in the clinical trials cooperative group (CTCG) setting. A subset of phase III trials opened by five CTCGs between August 1991 and March 2004 was evaluated. Design elements, experimental agents, redesign strategies, and pretrial accrual assessment supporting accrual predictions were abstracted from CTCG documents. Percent actual/predicted accrual rate averaged per month was calculated. Trials were categorized as having sufficient or insufficient accrual based on reason for trial termination. Analyses included univariate and bivariate summaries to identify potential trial factors associated with accrual sufficiency. Among 40 trials from one CTCG, 21 (52.5%) trials closed due to insufficient accrual. In 82 trials from five CTCGs, therapeutic trials accrued sufficiently more often than nontherapeutic trials (59% vs 27%, p = 0.05). Trials including pretrial accrual assessment more often achieved sufficient accrual than those without (67% vs 47%, p = 0.08). Fewer exclusion criteria, shorter consent forms, other CTCG participation, and trial design simplicity were not associated with achieving sufficient accrual. Trials accruing at a rate much lower than predicted (accrual rate) were consistently closed due to insufficient accrual. This trial subset under-represents certain experimental modalities. Data sources do not allow accounting for all factors potentially related to accrual success. Trial closure due to insufficient accrual is common. Certain trial design factors appear associated with attaining sufficient accrual. Defining

Maternal note-taking and infant care: a pilot randomised controlled trial.

Science.gov (United States)

Kistin, Caroline J; Barrero-Castillero, Alejandra; Lewis, Sheilajane; Hoch, Rachel; Philipp, Barbara L; Bauchner, Howard; Wang, C Jason

2012-10-01

A pilot randomised controlled trial was conducted with postpartum mothers to assess the feasibility and impact of note-taking during newborn teaching. Controls received standard teaching; the intervention group received pen and paper to take notes. Subjects were called 2 days post-discharge to assess infant sleep position, breastfeeding, car seat use, satisfaction and information recall. 126 mothers were randomised. There was a consistent trend that intervention subjects were more likely to report infant supine sleep position (88% vs 78%, relative risks (RR) 1.13; 95% CI 0.95 to 1.34), breastfeeding (96% vs 86%, RR 1.11; 95% CI 0.99 to 1.25) and correct car seat use (98% vs 87%, RR 1.12; 95% CI 1.00 to 1.25). Satisfaction and information recall did not differ. Among first-time mothers, intervention subjects were significantly more likely to report infant supine sleep position (95% vs 65%, RR 1.46; 95% CI 1.06 to 2.00). Maternal note-taking is feasible and potentially efficacious in promoting desirable infant care.

The 2 + 1 paradigm: an efficient algorithm for central reading of Mayo endoscopic subscores in global multicenter phase 3 ulcerative colitis clinical trials.

Science.gov (United States)

Ahmad, Harris A; Gottlieb, Klaus; Hussain, Fez

2016-02-01

Despite its importance and potential impact in clinical trials, central reading continues to be an under-represented topic in the literature about inflammatory bowel disease (IBD) clinical trials. Although several IBD studies have incorporated central reading to date, none have fully detailed the specific methodology with which the reads were conducted. Here we outline key principles for designing an efficient central reading paradigm for an ulcerative colitis (UC) study that addresses regulatory, operational and clinical expectations. As a step towards standardization of read methodology for the growing number of multicenter phase 3 clinical trials in IBD, we have applied these principles to the design of an optimal read methodology that we call the '2 + 1 paradigm.' The 2 + 1 paradigm involves the use of both site and central readers, validated scoring criteria and multiple measures for blinding readers, all of which contribute to reducing bias and generating a reliable endoscopic subscore that reflects endoscopic disease severity. The paradigm can be utilized while maintaining a practical workflow compatible with an operationally feasible clinical trial. The 2 + 1 paradigm represents a logical approach to endoscopic assessment in IBD clinical trials, one that should be considered attractive to prospective sponsors, contract research organizations, key opinion leaders and regulatory authorities and be ready for implementation and further evaluation. © The Author(s) 2015. Published by Oxford University Press and the Digestive Science Publishing Co. Limited.

How Do “Mute” Cicadas Produce Their Calling Songs?

Science.gov (United States)

Luo, Changqing; Wei, Cong; Nansen, Christian

2015-01-01

Insects have evolved a variety of structures and mechanisms to produce sounds, which are used for communication both within and between species. Among acoustic insects, cicada males are particularly known for their loud and diverse sounds which function importantly in communication. The main method of sound production in cicadas is the tymbal mechanism, and a relative small number of cicada species possess both tymbal and stridulatory organs. However, cicadas of the genus Karenia do not have any specialized sound-producing structures, so they are referred to as “mute”. This denomination is quite misleading, as they indeed produce sounds. Here, we investigate the sound-producing mechanism and acoustic communication of the “mute” cicada, Karenia caelatata, and discover a new sound-production mechanism for cicadas: i.e., K. caelatata produces impact sounds by banging the forewing costa against the operculum. The temporal, frequency and amplitude characteristics of the impact sounds are described. Morphological studies and reflectance-based analyses reveal that the structures involved in sound production of K. caelatata (i.e., forewing, operculum, cruciform elevation, and wing-holding groove on scutellum) are all morphologically modified. Acoustic playback experiments and behavioral observations suggest that the impact sounds of K. caelatata are used in intraspecific communication and function as calling songs. The new sound-production mechanism expands our knowledge on the diversity of acoustic signaling behavior in cicadas and further underscores the need for more bioacoustic studies on cicadas which lack tymbal mechanism. PMID:25714608

The Impact of Disulfiram Treatment on the Reinforcing Effects of Cocaine: A Randomized Clinical Trial

Science.gov (United States)

Haile, Colin N.; De La Garza, Richard; Mahoney, James J.; Nielsen, David A.; Kosten, Thomas R.; Newton, Thomas F.

2012-01-01

Background Clinical trials indicate that disulfiram (250 mg/d) reduces cocaine use, though one study found that treatment with lower doses of disulfiram (62.5 and 125 mg/d) increased cocaine use. We conducted the present study to better understand how disulfiram alters the reinforcing effects of cocaine in cocaine users. Methods Seventeen non-treatment seeking, cocaine-dependent volunteers participated in this double-blind, placebo-controlled, laboratory-based study. A cross-over design was utilized in which participants received placebo in one phase and disulfiram (250 mg/d) in the other. Following three days of study medication participants completed two choice sessions. In one they made 10 choices between receiving an intravenous infusion of saline or money that increased in value (US$ 0.05–16) and in the other cocaine (20 mg) or money. Results Participants chose cocaine more than saline under both disulfiram and placebo conditions (p<0.05). Unexpectedly, disulfiram increased both the number of cocaine and saline infusion choices (p<0.05). We next examined the relationship between disulfiram dose and cocaine choices. Disulfiram dose (mg/kg bodyweight) was negatively correlated with number of choices for cocaine (p<0.05). Disulfiram also enhanced cocaine-induced increases in cardiovascular measures (p's<0.05–0.01). Conclusions Disulfiram's impact on the reinforcing effects of cocaine depends on dose relative to body weight. Our results suggest that the use of weight-based medication doses would produce more reliable effects, consistent with weight-based dosing used in pediatrics and in preclinical research. Trial Registration Clinicaltrials.gov NCT00729300 PMID:23144826

A cluster randomised trial to assess the impact of clinical pathways on AMI management in rural Australian emergency departments

Directory of Open Access Journals (Sweden)

Snow Pamela C

2009-05-01

Full Text Available Abstract Background People living in rural Australia are more likely to die in hospital following an acute myocardial infarction than those living in major cities. While several factors, including time taken to access hospital care, contribute to this risk, it is also partially attributable to the lower uptake of evidence-based guidelines for the administration of thrombolytic drugs in rural emergency departments where up to one-third of eligible patients do not receive this life-saving intervention. Clinical pathways have the potential to link evidence to practice by integrating guidelines into local systems, but their impact has been hampered by variable implementation strategies and sub-optimal research designs. The purpose of this study is to determine the impact of a five-step clinical pathways implementation process on the timely and efficient administration of thrombolytic drugs for acute myocardial infarctions managed in rural Australian emergency departments. Methods/Design The design is a two-arm, cluster-randomised trial with rural hospital emergency departments that treat and do not routinely transfer acute myocardial infarction patients. Six rural hospitals in the state of Victoria will participate, with three in the intervention group and three in the control group. Intervention hospitals will participate in a five-step clinical pathway implementation process: engagement of clinicians, pathway development according to local resources and systems, reminders, education, and audit and feedback. Hospitals in the control group will each receive a hard copy of Australian national guidelines for chest pain and acute myocardial infarction management. Each group will include 90 cases to give a power of 80% at 5% significance level for the two primary outcome measures: proportion of those eligible for thrombolysis receiving the drug and time to delivery of thrombolytic drug. Discussion Improved compliance with thrombolytic guidelines via

Linking Calling Orientations to Organizational Attachment via Organizational Instrumentality

Science.gov (United States)

Cardador, M. Teresa; Dane, Erik; Pratt, Michael G.

2011-01-01

Despite an emerging interest in callings, researchers know little about whether calling orientations matter in the workplace. We explore the under-examined relationship between a calling orientation and employees' attachment to their organizations. Although some theory suggests that callings may be negatively related to organizational attachment,…

Protocol for a multicentre randomised feasibility STUdy evaluating the impact of a prognostic model for Management of BLunt chest wall trauma patients: STUMBL trial.

Science.gov (United States)

Battle, Ceri; Abbott, Zoe; Hutchings, Hayley A; O'Neill, Claire; Groves, Sam; Watkins, Alan; Lecky, Fiona E; Jones, Sally; Gagg, James; Body, Richard; Evans, Philip A

2017-07-10

A new prognostic model has been developed and externally validated, the aim of which is to assist in the management of the blunt chest wall trauma patient in the emergency department (ED). A definitive randomised controlled trial (impact trial) is required to assess the clinical and cost effectiveness of the new model before it can be accepted in clinical practice. The purpose of this trial is to assess the feasibility and acceptability of such a definitive trial and inform its design. This feasibility trial is designed to test the methods of a multicentre, cluster-randomised (stepped- wedge) trial, with a substantial qualitative component. Four EDs in England and Wales will collect data for all blunt chest wall trauma patients over a 5-month period; in the initial period acting as the controls (normal care), and in the second period acting as the interventions (in which the new model will be used). Baseline measurements including completion of the SF-12v2 will be obtained on initial assessment in the ED. Patient outcome data will then be collected for any subsequent hospitalisations. Data collection will conclude with a 6-week follow-up completion of two surveys (SF-12v2 and Client Services Receipt Inventory). Analysis of outcomes will focus on feasibility, acceptability and trial processes and will include recruitment and retention rates, attendance at clinician training rates and use of model in the ED. Qualitative feedback will be obtained through clinician interviews and a research nurse focus group. An evaluation of the feasibility of health economics outcomes data will be completed. Wales Research Ethics Committee 6 granted approval for the trial in September 2016. Patient recruitment will commence in February 2017. Planned dissemination is through publication in a peer-reviewed Emergency Medicine Journal , presentation at appropriate conferences and to stakeholders at professional meetings. ISRCTN95571506; Pre-results. © Article author(s) (or their

Ventilator-associated pneumonia in ARDS patients: the impact of prone positioning. A secondary analysis of the PROSEVA trial.

Science.gov (United States)

Ayzac, L; Girard, R; Baboi, L; Beuret, P; Rabilloud, M; Richard, J C; Guérin, C

2016-05-01

The goal of this study was to assess the impact of prone positioning on the incidence of ventilator-associated pneumonia (VAP) and the role of VAP in mortality in a recent multicenter trial performed on patients with severe ARDS. An ancillary study of a prospective multicenter randomized controlled trial on early prone positioning in patients with severe ARDS. In suspected cases of VAP the diagnosis was based on positive quantitative cultures of bronchoalveolar lavage fluid or tracheal aspirate at the 10(4) and 10(7) CFU/ml thresholds, respectively. The VAP cases were then subject to central, independent adjudication. The cumulative probabilities of VAP were estimated in each position group using the Aalen-Johansen estimator and compared using Gray's test. A univariate and a multivariate Cox model was performed to assess the impact of VAP, used as a time-dependent covariate for mortality hazard during the ICU stay. In the supine and prone position groups, the incidence rate for VAP was 1.18 (0.86-1.60) and 1.54 (1.15-2.02) per 100 days of invasive mechanical ventilation (p = 0.10), respectively. The cumulative probability of VAP at 90 days was estimated at 46.5 % (27-66) in the prone group and at 33.5 % (23-44) in the supine group. The difference between the two cumulative probability curves was not statistically significant (p = 0.11). In the univariate Cox model, VAP was associated with an increase in the mortality rate during the ICU stay [HR 1.65 (1.05-2.61), p = 0.03]. HR increased to 2.2 (1.39-3.52) (p position group, age, SOFA score, McCabe score, and immunodeficiency. In severe ARDS patients prone positioning did not reduce the incidence of VAP and VAP was associated with higher mortality.

Impact of National Institutes of Health Gastrointestinal PROMIS Measures in Clinical Practice: Results of a Multicenter Controlled Trial.

Science.gov (United States)

Almario, Christopher V; Chey, William D; Khanna, Dinesh; Mosadeghi, Sasan; Ahmed, Shahzad; Afghani, Elham; Whitman, Cynthia; Fuller, Garth; Reid, Mark; Bolus, Roger; Dennis, Buddy; Encarnacion, Rey; Martinez, Bibiana; Soares, Jennifer; Modi, Rushaba; Agarwal, Nikhil; Lee, Aaron; Kubomoto, Scott; Sharma, Gobind; Bolus, Sally; Spiegel, Brennan M R

2016-11-01

The National Institutes of Health (NIH) created the Patient Reported Outcomes Measurement Information System (PROMIS) to allow efficient, online measurement of patient-reported outcomes (PROs), but it remains untested whether PROMIS improves outcomes. Here, we aimed to compare the impact of gastrointestinal (GI) PROMIS measures vs. usual care on patient outcomes. We performed a pragmatic clinical trial with an off-on study design alternating weekly between intervention (GI PROMIS) and control arms at one Veterans Affairs and three university-affiliated specialty clinics. Adults with GI symptoms were eligible. Intervention patients completed GI PROMIS symptom questionnaires on an e-portal 1 week before their visit; PROs were available for review by patients and their providers before and during the clinic visit. Usual care patients were managed according to customary practices. Our primary outcome was patient satisfaction as determined by the Consumer Assessment of Healthcare Providers and Systems questionnaire. Secondary outcomes included provider interpersonal skills (Doctors' Interpersonal Skills Questionnaire (DISQ)) and shared decision-making (9-item Shared Decision Making Questionnaire (SDM-Q-9)). There were 217 and 154 patients in the GI PROMIS and control arms, respectively. Patient satisfaction was similar between groups (P>0.05). Intervention patients had similar assessments of their providers' interpersonal skills (DISQ 89.4±11.7 vs. 89.8±16.0, P=0.79) and shared decision-making (SDM-Q-9 79.3±12.4 vs. 79.0±22.0, P=0.85) vs. This is the first controlled trial examining the impact of NIH PROMIS in clinical practice. One-time use of GI PROMIS did not improve patient satisfaction or assessment of provider interpersonal skills and shared decision-making. Future studies examining how to optimize PROs in clinical practice are encouraged before widespread adoption.

Disproportionate Intrauterine Growth Intervention Trial At Term: DIGITAT

Directory of Open Access Journals (Sweden)

Huisjes Anjoke JM

2007-07-01

Full Text Available Abstract Background Around 80% of intrauterine growth restricted (IUGR infants are born at term. They have an increase in perinatal mortality and morbidity including behavioral problems, minor developmental delay and spastic cerebral palsy. Management is controversial, in particular the decision whether to induce labour or await spontaneous delivery with strict fetal and maternal surveillance. We propose a randomised trial to compare effectiveness, costs and maternal quality of life for induction of labour versus expectant management in women with a suspected IUGR fetus at term. Methods/design The proposed trial is a multi-centre randomised study in pregnant women who are suspected on clinical grounds of having an IUGR child at a gestational age between 36+0 and 41+0 weeks. After informed consent women will be randomly allocated to either induction of labour or expectant management with maternal and fetal monitoring. Randomisation will be web-based. The primary outcome measure will be a composite neonatal morbidity and mortality. Secondary outcomes will be severe maternal morbidity, maternal quality of life and costs. Moreover, we aim to assess neurodevelopmental and neurobehavioral outcome at two years as assessed by a postal enquiry (Child Behavioral Check List-CBCL and Ages and Stages Questionnaire-ASQ. Analysis will be by intention to treat. Quality of life analysis and a preference study will also be performed in the same study population. Health technology assessment with an economic analysis is part of this so called Digitat trial (Disproportionate Intrauterine Growth Intervention Trial At Term. The study aims to include 325 patients per arm. Discussion This trial will provide evidence for which strategy is superior in terms of neonatal and maternal morbidity and mortality, costs and maternal quality of life aspects. This will be the first randomised trial for IUGR at term. Trial registration Dutch Trial Register and ISRCTN

Timely and complete publication of economic evaluations alongside randomized controlled trials.

Science.gov (United States)

Thorn, Joanna C; Noble, Sian M; Hollingworth, William

2013-01-01

Little is known about the extent and nature of publication bias in economic evaluations. Our objective was to determine whether economic evaluations are subject to publication bias by considering whether economic data are as likely to be reported, and reported as promptly, as effectiveness data. Trials that intended to conduct an economic analysis and ended before 2008 were identified in the International Standard Randomised Controlled Trial Number (ISRCTN) register; a random sample of 100 trials was retrieved. Fifty comparator trials were randomly drawn from those not identified as intending to conduct an economic study. The trial start and end dates, estimated sample size and funder type were extracted. For trials planning economic evaluations, effectiveness and economic publications were sought; publication dates and journal impact factors were extracted. Effectiveness abstracts were assessed for whether they reached a firm conclusion that one intervention was most effective. Primary investigators were contacted about reasons for non-publication of results, or reasons for differential publication strategies for effectiveness and economic results. Trials planning an economic study were more likely to be funded by government (p = 0.01) and larger (p = 0.003) than other trials. The trials planning an economic evaluation had a mean of 6.5 (range 2.7-13.2) years since the trial end in which to publish their results. Effectiveness results were reported by 70 %, while only 43 % published economic evaluations (p economic results included the intervention being ineffective, and staffing issues. Funding source, time since trial end and length of study were not associated with a higher probability of publishing the economic evaluation. However, studies that were small or of unknown size were significantly less likely to publish economic evaluations than large studies (p journal impact factor was 1.6 points higher for effectiveness publications than for the

The Influence of Judgment Calls on Meta-Analytic Findings.

Science.gov (United States)

Tarrahi, Farid; Eisend, Martin

2016-01-01

Previous research has suggested that judgment calls (i.e., methodological choices made in the process of conducting a meta-analysis) have a strong influence on meta-analytic findings and question their robustness. However, prior research applies case study comparison or reanalysis of a few meta-analyses with a focus on a few selected judgment calls. These studies neglect the fact that different judgment calls are related to each other and simultaneously influence the outcomes of a meta-analysis, and that meta-analytic findings can vary due to non-judgment call differences between meta-analyses (e.g., variations of effects over time). The current study analyzes the influence of 13 judgment calls in 176 meta-analyses in marketing research by applying a multivariate, multilevel meta-meta-analysis. The analysis considers simultaneous influences from different judgment calls on meta-analytic effect sizes and controls for alternative explanations based on non-judgment call differences between meta-analyses. The findings suggest that judgment calls have only a minor influence on meta-analytic findings, whereas non-judgment call differences between meta-analyses are more likely to explain differences in meta-analytic findings. The findings support the robustness of meta-analytic results and conclusions.

Optimal scheduling in call centers with a callback option

OpenAIRE

Legros , Benjamin; Jouini , Oualid; Koole , Ger

2016-01-01

International audience; We consider a call center model with a callback option, which allows to transform an inbound call into an outbound one. A delayed call, with a long anticipated waiting time, receives the option to be called back. We assume a probabilistic customer reaction to the callback offer (option). The objective of the system manager is to characterize the optimal call scheduling that minimizes the expected waiting and abandonment costs. For the single-server case, we prove that ...

Flight calls and orientation

DEFF Research Database (Denmark)

Larsen, Ole Næsbye; Andersen, Bent Bach; Kropp, Wibke

2008-01-01

flight calls was simulated by sequential computer controlled activation of five loudspeakers placed in a linear array perpendicular to the bird's migration course. The bird responded to this stimulation by changing its migratory course in the direction of that of the ‘flying conspecifics' but after about......  In a pilot experiment a European Robin, Erithacus rubecula, expressing migratory restlessness with a stable orientation, was video filmed in the dark with an infrared camera and its directional migratory activity was recorded. The flight overhead of migrating conspecifics uttering nocturnal...... 30 minutes it drifted back to its original migration course. The results suggest that songbirds migrating alone at night can use the flight calls from conspecifics as additional cues for orientation and that they may compare this information with other cues to decide what course to keep....

The Impact of Achieve3000 on Elementary Literacy Outcomes: Randomized Control Trial Evidence, 2013-14 to 2014-15. Eye on Evaluation. DRA Report No. 16.02

Science.gov (United States)

Hill, Darryl V.; Lenard, Matthew A.

2016-01-01

In 2013-14, the Wake County Public School System (WCPSS) launched Achieve3000 as a randomized controlled trial in 16 elementary schools. Achieve3000 is an early literacy program that differentiates non-fiction reading passages based on individual students' Lexile scores. Twoyear results show that Achieve3000 did not have a significant impact on…

Long-Term Impact of Endometrial Cancer Diagnosis and Treatment on Health-Related Quality of Life and Cancer Survivorship: Results From the Randomized PORTEC-2 Trial

Energy Technology Data Exchange (ETDEWEB)

Boer, Stephanie M. de, E-mail: s.m.de_boer.ONCO@lumc.nl [Department of Radiation Oncology, Leiden University Medical Center, Leiden (Netherlands); Nout, Remi A. [Department of Radiation Oncology, Leiden University Medical Center, Leiden (Netherlands); Jürgenliemk-Schulz, Ina M. [Department of Radiation Oncology, University Medical Center Utrecht, Utrecht (Netherlands); Jobsen, Jan J. [Department of Radiotherapy, Medisch Spectrum Twente, Enschede (Netherlands); Lutgens, Ludy C.H.W. [Department of Radiation Oncology (MAASTRO), University Medical Centre Maastricht (Netherlands); Steen-Banasik, Elzbieta M. van der [Arnhem Radiotherapy Institute (ARTI), Arnhem (Netherlands); Mens, Jan Willem M. [Department of Radiation Oncology, Erasmus MC-Daniel den Hoed Cancer Center, Rotterdam (Netherlands); Slot, Annerie [Radiotherapy Institute Friesland, Leeuwarden (Netherlands); Stenfert Kroese, Marika C. [Department of Radiation Oncology, Radiotherapy Group Deventer, Deventer (Netherlands); Oerlemans, Simone [Research Department, Netherlands Comprehensive Cancer Organization, Eindhoven (Netherlands); Center of Research on Psychology in Somatic Diseases, Tilburg University, Tilburg (Netherlands); Putter, Hein [Department of Medical Statistics, Leiden University Medical Center, Leiden (Netherlands); Verhoeven-Adema, Karen W. [Comprehensive Cancer Center The Netherlands-West, Leiden (Netherlands); Nijman, Hans W. [Department of Gynecologic Oncology, University Medical Center Groningen, Groningen (Netherlands); Creutzberg, Carien L. [Department of Radiation Oncology, Leiden University Medical Center, Leiden (Netherlands)

2015-11-15

Purpose: To evaluate the long-term health-related quality of life (HRQL) after external beam radiation therapy (EBRT) or vaginal brachytherapy (VBT) among PORTEC-2 trial patients, evaluate long-term bowel and bladder symptoms, and assess the impact of cancer on these endometrial cancer (EC) survivors. Patients and Methods: In the PORTEC-2 trial, 427 patients with stage I high–intermediate-risk EC were randomly allocated to EBRT or VBT. The 7- and 10-year HRQL questionnaires consisted of EORTC QLQ-C30; subscales for bowel and bladder symptoms; the Impact of Cancer Questionnaire; and 14 questions on comorbidities, walking aids, and incontinence pads. Analysis was done using linear mixed models for subscales and (ordinal) logistic regression with random effects for single items. A two-sided P value <.01 was considered statistically significant. Results: Longitudinal HRQL analysis showed persisting higher rates of bowel symptoms with EBRT, without significant differences in global health or any of the functioning scales. At 7 years, clinically relevant fecal leakage was reported by 10.6% in the EBRT group, versus 1.8% for VBT (P=.03), diarrhea by 8.4% versus 0.9% (P=.04), limitations due to bowel symptoms by 10.5% versus 1.8% (P=.001), and bowel urgency by 23.3% versus 6.6% (P<.001). Urinary urgency was reported by 39.3% of EBRT patients, 25.5% for VBT, P=.05. No difference in sexual activity was seen between treatment arms. Long-term impact of cancer scores was higher among the patients who had an EC recurrence or second cancer. Conclusions: More than 7 years after treatment, EBRT patients reported more bowel symptoms with impact on daily activities, and a trend for more urinary symptoms, without impact on overall quality of life or difference in cancer survivorship issues.

Long-Term Impact of Endometrial Cancer Diagnosis and Treatment on Health-Related Quality of Life and Cancer Survivorship: Results From the Randomized PORTEC-2 Trial

International Nuclear Information System (INIS)

Boer, Stephanie M. de; Nout, Remi A.; Jürgenliemk-Schulz, Ina M.; Jobsen, Jan J.; Lutgens, Ludy C.H.W.; Steen-Banasik, Elzbieta M. van der; Mens, Jan Willem M.; Slot, Annerie; Stenfert Kroese, Marika C.; Oerlemans, Simone; Putter, Hein; Verhoeven-Adema, Karen W.; Nijman, Hans W.; Creutzberg, Carien L.

2015-01-01

Purpose: To evaluate the long-term health-related quality of life (HRQL) after external beam radiation therapy (EBRT) or vaginal brachytherapy (VBT) among PORTEC-2 trial patients, evaluate long-term bowel and bladder symptoms, and assess the impact of cancer on these endometrial cancer (EC) survivors. Patients and Methods: In the PORTEC-2 trial, 427 patients with stage I high–intermediate-risk EC were randomly allocated to EBRT or VBT. The 7- and 10-year HRQL questionnaires consisted of EORTC QLQ-C30; subscales for bowel and bladder symptoms; the Impact of Cancer Questionnaire; and 14 questions on comorbidities, walking aids, and incontinence pads. Analysis was done using linear mixed models for subscales and (ordinal) logistic regression with random effects for single items. A two-sided P value <.01 was considered statistically significant. Results: Longitudinal HRQL analysis showed persisting higher rates of bowel symptoms with EBRT, without significant differences in global health or any of the functioning scales. At 7 years, clinically relevant fecal leakage was reported by 10.6% in the EBRT group, versus 1.8% for VBT (P=.03), diarrhea by 8.4% versus 0.9% (P=.04), limitations due to bowel symptoms by 10.5% versus 1.8% (P=.001), and bowel urgency by 23.3% versus 6.6% (P<.001). Urinary urgency was reported by 39.3% of EBRT patients, 25.5% for VBT, P=.05. No difference in sexual activity was seen between treatment arms. Long-term impact of cancer scores was higher among the patients who had an EC recurrence or second cancer. Conclusions: More than 7 years after treatment, EBRT patients reported more bowel symptoms with impact on daily activities, and a trend for more urinary symptoms, without impact on overall quality of life or difference in cancer survivorship issues.

Design and rationale of the Procalcitonin Antibiotic Consensus Trial (ProACT), a multicenter randomized trial of procalcitonin antibiotic guidance in lower respiratory tract infection.

Science.gov (United States)

Huang, David T; Angus, Derek C; Chang, Chung-Chou H; Doi, Yohei; Fine, Michael J; Kellum, John A; Peck-Palmer, Octavia M; Pike, Francis; Weissfeld, Lisa A; Yabes, Jonathan; Yealy, Donald M

2017-08-29

Overuse of antibiotics is a major public health problem, contributing to growing antibiotic resistance. Procalcitonin has been reported to be commonly elevated in bacterial, but not viral infection. Multiple European trials found procalcitonin-guided care reduced antibiotic use in lower respiratory tract infection, with no apparent harm. However, applicability to US practice is limited due to trial design features impractical in the US, between-country differences, and residual safety concerns. The Procalcitonin Antibiotic Consensus Trial (ProACT) is a multicenter randomized trial to determine the impact of a procalcitonin antibiotic prescribing guideline, implemented with basic reproducible strategies, in US patients with lower respiratory tract infection. We describe the trial methods using the Consolidated Standards of Reporting Trials (CONSORT) framework, and the rationale for key design decisions, including choice of eligibility criteria, choice of control arm, and approach to guideline implementation. ClinicalTrials.gov NCT02130986 . Registered May 1, 2014.

Porcine dermis compared with polypropylene mesh for laparoscopic sacrocolpopexy: a randomized controlled trial.

Science.gov (United States)

Culligan, Patrick J; Salamon, Charbel; Priestley, Jennifer L; Shariati, Amir

2013-01-01

To compare the surgical outcomes 12 months after laparoscopic sacrocolpopexy performed with porcine dermis and the current gold standard of polypropylene mesh. Patients scheduled for laparoscopic sacrocolpopexy were eligible for this randomized controlled trial. Both our clinical research nurse and the patients were blinded as to which material was used. Our primary end point was objective anatomic cure defined as no pelvic organ prolapse quantification (POP-Q) points Stage 2 or greater at any postoperative interval. Our sample size calculation called for 57 patients in each group to achieve 90% power to detect a 23% difference in objective anatomic cure at 12 months (α=0.05). Our secondary end point was clinical cure. Any patient with a POP-Q point greater than zero, or Point C less than or equal to -5, or any complaints of prolapse symptoms whatsoever on Pelvic Floor Distress Inventory-20 or Pelvic Floor Impact Questionnaire, Short Form 7, or reoperation for prolapse were considered "clinical failures"; the rest were "clinical cures." Statistical comparisons were performed using the χ or independent samples t test as appropriate. As expected, there were no preoperative differences between the porcine (n=57) and mesh (n=58) groups. The 12-month objective anatomic cure rates for the porcine and mesh groups were 80.7% and 86.2%, respectively (P=.24), and the "clinical cure" rates for the porcine and mesh groups were 84.2% and 89.7%, respectively (P=.96). Pelvic Floor Distress Inventory-20 and Pelvic Floor Impact Questionnaire, Short Form 7 score improvements were significant for both groups with no differences found between groups. There were no major operative complications. There were similar outcomes in subjective or objective results 12 months after laparoscopic sacrocolpopexy performed with either porcine dermis or polypropylene mesh. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00564083. I.

Models and impact of patient and public involvement in studies carried out by the Medical Research Council Clinical Trials Unit at University College London: findings from ten case studies.

Science.gov (United States)

South, Annabelle; Hanley, Bec; Gafos, Mitzy; Cromarty, Ben; Stephens, Richard; Sturgeon, Kate; Scott, Karen; Cragg, William J; Tweed, Conor D; Teera, Jacqueline; Vale, Claire L

2016-07-29

Patient and public involvement (PPI) in studies carried out by the UK Medical Research Council Clinical Trials Unit (MRC CTU) at University College London varies by research type and setting. We developed a series of case studies of PPI to document and share good practice. We used purposive sampling to identify studies representing the scope of research at the MRC CTU and different approaches to PPI. We carried out semi-structured interviews with staff and patient representatives. Interview notes were analysed descriptively to categorise the main aims and motivations for involvement; activities undertaken; their impact on the studies and lessons learned. We conducted 19 interviews about ten case studies, comprising one systematic review, one observational study and 8 randomised controlled trials in HIV and cancer. Studies were either open or completed, with start dates between 2003 and 2011. Interviews took place between March and November 2014 and were updated in summer 2015 where there had been significant developments in the study (i.e. if the study had presented results subsequent to the interview taking place). A wide range of PPI models, including representation on trial committees or management groups, community engagement, one-off task-focused activities, patient research partners and participant involvement had been used. Overall, interviewees felt that PPI had a positive impact, leading to improvements, for example in the research question; study design; communication with potential participants; study recruitment; confidence to carry out or complete a study; interpretation and communication of results; and influence on future research. A range of models of PPI can benefit clinical studies. Researchers should consider different approaches to PPI, based on the desired impact and the people they want to involve. Use of multiple models may increase the potential impacts of PPI in clinical research.

Lunar phases and crisis center telephone calls.

Science.gov (United States)

Wilson, J E; Tobacyk, J J

1990-02-01

The lunar hypothesis, that is, the notion that lunar phases can directly affect human behavior, was tested by time-series analysis of 4,575 crisis center telephone calls (all calls recorded for a 6-month interval). As expected, the lunar hypothesis was not supported. The 28-day lunar cycle accounted for less than 1% of the variance of the frequency of crisis center calls. Also, as hypothesized from an attribution theory framework, crisis center workers reported significantly greater belief in lunar effects than a non-crisis-center-worker comparison group.

Correlates of Gay-Related Name-Calling in Schools

Science.gov (United States)

Slaatten, Hilde; Hetland, Jørn; Anderssen, Norman

2015-01-01

The aim of this study was to examine whether attitudes about gay-related name-calling, social norms concerning gay-related name-calling among co-students, teacher intervention, and school-related support would predict whether secondary school pupils had called another pupil a gay-related name during the last month. A total of 921 ninth-grade…

47 CFR 90.241 - Radio call box operations.

Science.gov (United States)

2010-10-01

... remains on for a period in excess of three minutes. The automatic cutoff system must be designed so the... Public Safety Pool for highway call box systems subject to the following requirements: (1) Call box... effective radiated power (ERP). (3) The height of a call box antenna may not exceed 6.1 meters (20 feet...

Strategies to improve retention in randomised trials

Science.gov (United States)

Brueton, Valerie C; Tierney, Jayne; Stenning, Sally; Harding, Seeromanie; Meredith, Sarah; Nazareth, Irwin; Rait, Greta

2013-01-01

LANGUAGE SUMMARY Methods that might help to keep people in randomised trials Background Most trials follow people up to collect data through personal contact after they have been recruited. Some trials get data from other sources, such as routine collected data or disease registers. There are many ways to collect data from people in trials, and these include using letters, the internet, telephone calls, text messaging, face-to-face meetings or the return of medical test kits. Most trials have missing data, for example, because people are too busy to reply, are unable to attend a clinic, have moved or no longer want to participate. Sometimes data has not been recorded at study sites, or are not sent to the trial co-ordinating centre. Researchers call this 'loss to follow-up', 'drop out' or 'attrition' and it can affect the trial's results. For example, if the people with the most or least severe symptoms do not return questionnaires or attend a follow-up visit, this will bias the findings of the trial. Many methods are used by researchers to keep people in trials. These encourage people to send back data by questionnaire, return to a clinic or hospital for trial-related tests, or be seen by a health or community care worker. Study characteristics This review identified methods that encouraged people to stay in trials. We searched scientific databases for randomised studies (where people are allocated to one of two or more possible treatments in a random manner) or quasi-randomised studies (where allocation is not really random, e.g. based on date of birth, order in which they attended clinic) that compared methods of increasing retention in trials. We included trials of participants from any age, gender, ethnic, cultural, language and geographic groups. Key results The methods that appeared to work were offering or giving a small amount of money for return of a completed questionnaire and enclosing a small amount of money with a questionnaire with the promise of a further

Radiochemotherapy of locally advanced anal canal carcinoma: Prospective assessment of early impact on the quality of life (randomized trial ACCORD 03)

International Nuclear Information System (INIS)

Tournier-Rangeard, Laetitia; Mercier, Mariette; Peiffert, Didier; Gerard, Jean-Pierre; Romestaing, Pascale; Lemanski, Claire; Mirabel, Xavier; Pommier, Pascal; Denis, Bernard

2008-01-01

Background and purpose: The aim of this study was to prospectively assess the quality of life (QOL) of patients treated by concomitant chemo radiation for locally advanced anal canal carcinoma. Materials and methods: We report on a subgroup of 119 patients enrolled in a 306-patient therapeutic intensification prospective trial (ACCORD 03). This trial evaluated the impact on colostomy-free survival of induction chemotherapy and/or high dose radiotherapy (factorial design 2 * 2 treatment arms). QOL was assessed both before and 2 months after treatment using the EORTC QLQ-C30 questionnaire as well as a questionnaire relating to anal sphincter conservative treatment (AS-CT). Results: Compared to pre-treatment scores, patients reported significant improvement in their emotional function (+8.4 points p = 0.002), global health status (+5.9 points p = 0.0007), as well as a decrease in insomnia (-13.8 points p < 0.0001), constipation (-12.0 points p < 0.0001), appetite loss (-10.3 points p < 0.0001) and pain (-9.6 points p = 0.0002). The AS-CT degree of satisfaction with intestinal functions score was increased (+11.2 points p < 0.0001). Conclusion: This is the first prospective study comparing QOL of patients with advanced anal canal carcinoma, before and 2 months after conservative treatment. Two months after treatment, QOL was improved. Induction chemotherapy and/or high dose radiotherapy did not provide a negative impact on QOL

Coaching "Callings" throughout the Adult Life Cycle.

Science.gov (United States)

Hudson, Frederic M.

2001-01-01

The process of "callings" continues throughout life. Coaching can connect the present to the future in a meaningful way. Callings represent a value shift requiring revision of the nature and scope of one's central purpose in life and meaningful activities. (JOW)

A controlled trial of an expert system and self-help manual intervention based on the stages of change versus standard self-help materials in smoking cessation.

Science.gov (United States)

Aveyard, Paul; Griffin, Carl; Lawrence, Terry; Cheng, K K

2003-03-01

To examine the population impact and effectiveness of the Pro-Change smoking cessation course based on the Transtheoretical Model (TTM) compared to standard self-help smoking cessation literature. Randomized controlled trial. Sixty-five West Midlands general practices. Randomly sampled patients recorded as smokers by their general practitioners received an invitation letter and 2471 current smokers agreed. Responders were randomized to one of four interventions. The control group received standard self-help literature. In the Manual intervention group, participants received the Pro-Change system, a self-help workbook and three questionnaires at 3-monthly intervals, which generated individually tailored feedback. In the Phone intervention group, participants received the Manual intervention plus three telephone calls. In the Nurse intervention group, participants received the Manual intervention plus three visits to the practice nurse. Biochemically confirmed point prevalence of being quit and 6-month sustained abstinence, 12 months after study commencement. A total of 9.1% of registered current smokers participated, of whom 83.0% were not ready to quit. Less than half of participants returned questionnaires to generate second and third individualized feedback. Telephone calls reached 75% of those scheduled, but few participants visited the nurse. There were small differences between the three Pro-Change arms. The odds ratio (95% confidence intervals) for all Pro-Change arms combined versus the control arm were 1.50 (0.85-2.67) and 1.53 (0.76-3.10), for point prevalence and 6-month abstinence, respectively. This constitutes 2.1% of the TTM group versus 1.4% of the control group achieving confirmed 6-month sustained abstinence. There was no statistically significant benefit of the intervention apparent in this trial and the high relapse of quitters means that any population impact is small.

The impact of endpoint measures in rheumatoid arthritis clinical trials

NARCIS (Netherlands)

van der Heide, A.; Jacobs, J. W.; Dinant, H. J.; Bijlsma, J. W.

1992-01-01

In clinical trials on the effectiveness of disease-modifying antirheumatic drugs (DMARDs) in patients with rheumatoid arthritis (RA), it is common to apply a large number of endpoint measures. This practice has several disadvantages. To determine which endpoint measures are most valuable, reports of

Study protocol: Couples Partnering for Lipid Enhancing Strategies (CouPLES – a randomized, controlled trial

Directory of Open Access Journals (Sweden)

Weinberger Morris

2009-02-01

Full Text Available Abstract Background Almost 50% of Americans have elevated low-density lipoprotein cholesterol (LDL-C. The behaviors required to lower LDL-C levels may be difficult to adhere to if they are inconsistent with spouses' health practices, and, alternatively, may be enhanced by enlisting support from the spouse. This trial extends previous trials by requiring spouse enrollment, teaching spouses how to provide emotional and instrumental support, allowing patients to decide which component of the intervention they would like to receive, and having patients determine their own goals and action plans. Methods Veteran outpatients with above-goal LDL-C (N = 250 and their spouses are randomized, as a couple, to receive printed education materials only or the materials plus an 11-month, nurse-delivered, telephone-based intervention. The intervention contains four modules: medication adherence, diet, exercise, and patient-physician communication. Patients decide which modules they complete and in which order; modules may be repeated or omitted. Telephone calls are to patients and spouses separately and occur monthly. During each patient telephone call, patients' progress is reviewed, and patients create goals and action plans for the upcoming month. During spouse telephone calls, which occur within one week of patient calls, spouses are informed of patients' goals and action plans and devise strategies to increase emotional and instrumental support. The primary outcome is patients' LDL-C, measured at baseline, 6 months, and 11 months. Linear mixed models will be used to test the primary hypothesis that an 11-month, telephone-based patient-spouse intervention will result in a greater reduction in LDL-C as compared to printed education materials. Various process measures, including social support, self-efficacy, medication adherence, dietary behavior, and exercise, are also assessed to explain any change, or lack thereof, in LDL-C. Discussion Given the social

Challenges from variation across regions in cost effectiveness analysis in multi-regional clinical trials

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Yunbo Chu

2016-10-01

Full Text Available Economic evaluation in the form of cost-effectiveness analysis has become a popular means to inform decisions in healthcare. With multi-regional clinical trials in a global development program becoming a new venue for drug efficacy testing in recent decades, questions in methods for cost-effectiveness analysis in the multi-regional clinical trials setting also emerge. This paper addresses some challenges from variation across regions in cost effectiveness analysis in multi-regional clinical trials. Several discussion points are raised for further attention and a multi-regional clinical trial example is presented to illustrate the implications in industrial application. A general message is delivered to call for a depth discussion by all stakeholders to reach an agreement on a good practice in cost-effectiveness analysis in the multi-regional clinical trials. Meanwhile, we recommend an additional consideration of cost-effectiveness analysis results based on the clinical evidence from a certain homogeneous population as sensitivity or scenario analysis upon data availability.

A Randomized, Double-Blind Placebo Controlled Trial of Balapiravir, a Polymerase Inhibitor, in Adult Dengue Patients

Science.gov (United States)

Nguyen, Nguyet Minh; Tran, Chau Nguyen Bich; Phung, Lam Khanh; Duong, Kien Thi Hue; Huynh, Huy le Anh; Farrar, Jeremy; Nguyen, Quyen Than Ha; Tran, Hien Tinh; Nguyen, Chau Van Vinh; Merson, Laura; Hoang, Long Truong; Hibberd, Martin L.; Aw, Pauline P. K.; Wilm, Andreas; Nagarajan, Niranjan; Nguyen, Dung Thi; Pham, Mai Phuong; Nguyen, Truong Thanh; Javanbakht, Hassan; Klumpp, Klaus; Hammond, Janet; Petric, Rosemary; Wolbers, Marcel; Nguyen, Chinh Tran; Simmons, Cameron P.

2013-01-01

Background. Dengue is the most common arboviral infection of humans. There are currently no specific treatments for dengue. Balapiravir is a prodrug of a nucleoside analogue (called R1479) and an inhibitor of hepatitis C virus replication in vivo. Methods. We conducted in vitro experiments to determine the potency of balapiravir against dengue viruses and then an exploratory, dose-escalating, randomized placebo-controlled trial in adult male patients with dengue with treatment. Conclusions. Although this trial, the first of its kind in dengue, does not support balapiravir as a candidate drug, it does establish a framework for antiviral treatment trials in dengue and provides the field with a clinically evaluated benchmark molecule. Clinical Trials Registration. NCT01096576. PMID:22807519

Two-year impact of community-based health screening and parenting groups on child development in Zambia: Follow-up to a cluster-randomized controlled trial.

Science.gov (United States)

Rockers, Peter C; Zanolini, Arianna; Banda, Bowen; Chipili, Mwaba Moono; Hughes, Robert C; Hamer, Davidson H; Fink, Günther

2018-04-01

Early childhood interventions have potential to offset the negative impact of early adversity. We evaluated the impact of a community-based parenting group intervention on child development in Zambia. We conducted a non-masked cluster-randomized controlled trial in Southern Province, Zambia. Thirty clusters of villages were matched based on population density and distance from the nearest health center, and randomly assigned to intervention (15 clusters, 268 caregiver-child dyads) or control (15 clusters, 258 caregiver-child dyads). Caregivers were eligible if they had a child 6 to 12 months old at baseline. In intervention clusters, caregivers were visited twice per month during the first year of the study by child development agents (CDAs) and were invited to attend fortnightly parenting group meetings. Parenting groups selected "head mothers" from their communities who were trained by CDAs to facilitate meetings and deliver a diverse parenting curriculum. The parenting group intervention, originally designed to run for 1 year, was extended, and households were visited for a follow-up assessment at the end of year 2. The control group did not receive any intervention. Intention-to-treat analysis was performed for primary outcomes measured at the year 2 follow-up: stunting and 5 domains of neurocognitive development measured using the Bayley Scales of Infant and Toddler Development-Third Edition (BSID-III). In order to show Cohen's d estimates, BSID-III composite scores were converted to z-scores by standardizing within the study population. In all, 195/268 children (73%) in the intervention group and 182/258 children (71%) in the control group were assessed at endline after 2 years. The intervention significantly reduced stunting (56/195 versus 72/182; adjusted odds ratio 0.45, 95% CI 0.22 to 0.92; p = 0.028) and had a significant positive impact on language (β 0.14, 95% CI 0.01 to 0.27; p = 0.039). The intervention did not significantly impact cognition (β 0

Two-year impact of community-based health screening and parenting groups on child development in Zambia: Follow-up to a cluster-randomized controlled trial.

Directory of Open Access Journals (Sweden)

Peter C Rockers

2018-04-01

Full Text Available Early childhood interventions have potential to offset the negative impact of early adversity. We evaluated the impact of a community-based parenting group intervention on child development in Zambia.We conducted a non-masked cluster-randomized controlled trial in Southern Province, Zambia. Thirty clusters of villages were matched based on population density and distance from the nearest health center, and randomly assigned to intervention (15 clusters, 268 caregiver-child dyads or control (15 clusters, 258 caregiver-child dyads. Caregivers were eligible if they had a child 6 to 12 months old at baseline. In intervention clusters, caregivers were visited twice per month during the first year of the study by child development agents (CDAs and were invited to attend fortnightly parenting group meetings. Parenting groups selected "head mothers" from their communities who were trained by CDAs to facilitate meetings and deliver a diverse parenting curriculum. The parenting group intervention, originally designed to run for 1 year, was extended, and households were visited for a follow-up assessment at the end of year 2. The control group did not receive any intervention. Intention-to-treat analysis was performed for primary outcomes measured at the year 2 follow-up: stunting and 5 domains of neurocognitive development measured using the Bayley Scales of Infant and Toddler Development-Third Edition (BSID-III. In order to show Cohen's d estimates, BSID-III composite scores were converted to z-scores by standardizing within the study population. In all, 195/268 children (73% in the intervention group and 182/258 children (71% in the control group were assessed at endline after 2 years. The intervention significantly reduced stunting (56/195 versus 72/182; adjusted odds ratio 0.45, 95% CI 0.22 to 0.92; p = 0.028 and had a significant positive impact on language (β 0.14, 95% CI 0.01 to 0.27; p = 0.039. The intervention did not significantly impact

Performance indicators for call centers with impatience

NARCIS (Netherlands)

Jouini, O.; Koole, G.M.; Roubos, A.

2013-01-01

An important feature of call center modeling is the presence of impatient customers. This article considers single-skill call centers including customer abandonments. A number of different service-level definitions are structured, including all those used in practice, and the explicit computation of

Calling, is there anything special about it?

African Journals Online (AJOL)

2016-07-15

Jul 15, 2016 ... when a pastor is installed or a new candidate is ordained, 'The one who calls you is faithful .... extension to secular work of the dignity of a calling' (Fowler ... For Luther, therefore, the private life of devotion exercised in the.

Protocol for the Quick Clinical study: a randomised controlled trial to assess the impact of an online evidence retrieval system on decision-making in general practice

Directory of Open Access Journals (Sweden)

Kidd Michael R

2006-08-01

Full Text Available Abstract Background Online information retrieval systems have the potential to improve patient care but there are few comparative studies of the impact of online evidence on clinicians' decision-making behaviour in routine clinical work. Methods/design A randomized controlled parallel design is employed to assess the effectiveness of an online evidence retrieval system, Quick Clinical (QC in improving clinical decision-making processes in general practice. Eligible clinicians are randomised either to receive access or not to receive access to QC in their consulting rooms for 12 months. Participants complete pre- and post trial surveys. Two-hundred general practitioners are recruited. Participants must be registered to practice in Australia, have a computer with Internet access in their consulting room and use electronic prescribing. Clinicians planning to retire or move to another practice within 12 months or participating in any other clinical trial involving electronic extraction of prescriptions data are excluded from the study. The primary end-points for the study is clinician acceptance and use of QC and the resulting change in decision-making behaviour. The study will examine prescribing patterns related to frequently prescribed medications where there has been a recent significant shift in recommendations regarding their use based upon new evidence. Secondary outcome measures include self-reported changes in diagnosis, patient education, prescriptions written, investigations and referrals. Discussion A trial under experimental conditions is an effective way of examining the impact of using QC in routine general practice consultations.

Consumer participation in early detection of the deteriorating patient and call activation to rapid response systems: a literature review.

Science.gov (United States)

Vorwerk, Jane; King, Lindy

2016-01-01

This review investigated the impact of consumer participation in recognition of patient deterioration and response through call activation in rapid response systems. Nurses and doctors have taken the main role in recognition and response to patient deterioration through hospital rapid response systems. Yet patients and visitors (consumers) have appeared well placed to notice early signs of deterioration. In response, many hospitals have sought to partner health professionals with consumers in detection and response to early deterioration. However, to date, there have been no published research-based reviews to establish the impact of introducing consumer involvement into rapid response systems. A critical research-based review was undertaken. A comprehensive search of databases from 2006-2014 identified 11 studies. Critical appraisal of these studies was undertaken and thematic analysis of the findings revealed four major themes. Following implementation of the consumer activation programmes, the number of calls made by the consumers following detection of deterioration increased. Interestingly, the number of staff calls also increased. Importantly, mortality numbers were found to decrease in one major study following the introduction of consumer call activation. Consumer and staff knowledge and satisfaction with the new programmes indicated mixed results. Initial concerns of the staff over consumer involvement overwhelming the rapid response systems did not eventuate. Evaluation of successful consumer-activated programmes indicated the importance of: effective staff education and training; ongoing consumer education by nurses and clear educational materials. Findings indicated positive patient outcomes following introduction of consumer call activation programmes within rapid response systems. Effective consumer programmes included information that was readily accessible, easy-to-understand and available in a range of multimedia materials accompanied by the

Ultrasound call detection in capybara

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Selene S.C. Nogueira

2012-07-01

Full Text Available The vocal repertoire of some animal species has been considered a non-invasive tool to predict distress reactivity. In rats ultrasound emissions were reported as distress indicator. Capybaras[ vocal repertoire was reported recently and seems to have ultrasound calls, but this has not yet been confirmed. Thus, in order to check if a poor state of welfare was linked to ultrasound calls in the capybara vocal repertoire, the aim of this study was to track the presence of ultrasound emissions in 11 animals under three conditions: 1 unrestrained; 2 intermediately restrained, and 3 highly restrained. The ultrasound track identified frequencies in the range of 31.8±3.5 kHz in adults and 33.2±8.5 kHz in juveniles. These ultrasound frequencies occurred only when animals were highly restrained, physically restrained or injured during handling. We concluded that these calls with ultrasound components are related to pain and restraint because they did not occur when animals were free of restraint. Thus we suggest that this vocalization may be used as an additional tool to assess capybaras[ welfare.

Relabeling the Medications We Call Antidepressants

Directory of Open Access Journals (Sweden)

David Antonuccio

2012-01-01

Full Text Available This paper raises the question about whether the data on the medications we call antidepressants justify the label of antidepressant. The authors argue that a true antidepressant should be clearly superior to placebo, should offer a risk/benefit balance that exceeds that of alternative treatments, should not increase suicidality, should not increase anxiety and agitation, should not interfere with sexual functioning, and should not increase depression chronicity. Unfortunately, these medications appear to fall short on all of these dimensions. Many of the “side effects” of these medications have larger effect sizes than the antidepressant effect size. To call these medications antidepressants may make sense from a marketing standpoint but may be misleading from a scientific perspective. Consumers deserve a label that more accurately reflects the data on the largest effects and helps them understand the range of effects from these medications. In other words, it may make just as much sense to call these medications antiaphrodisiacs as antidepressants because the negative effects on libido and sexual functioning are so common. It can be argued that a misleading label may interfere with our commitment to informed consent. Therefore, it may be time to stop calling these medications antidepressants.

The Barbados Emergency Ambulance Service: High Frequency of Nontransported Calls

Directory of Open Access Journals (Sweden)

Sherwin E. Phillips

2012-01-01

Full Text Available Objectives. There are no published studies on the Barbados Emergency Ambulance Service and no assessment of the calls that end in nontransported individuals. We describe reasons for the nontransport of potential clients. Methods. We used the Emergency Medical Dispatch (Medical Priority Dispatch System instrument, augmented with five local call types, to collect information on types of calls. The calls were categorised under 7 headings. Correlations between call types and response time were calculated. Results. Most calls were from the category medical (54%. Nineteen (19% percent of calls were in the non-transported category. Calls from call type Cancelled accounted for most of these and this was related to response time, while Refused service was inversely related (. Conclusions. The Barbados Ambulance Service is mostly used by people with a known illness and for trauma cases. One-fifth of calls fall into a category where the ambulance is not used often due to cancellation which is related to response time. Other factors such as the use of alternative transport are also important. Further study to identify factors that contribute to the non-transported category of calls is necessary if improvements in service quality are to be made.

Protocol for a randomised controlled trial examining the impact of a web-based personally controlled health management system on the uptake of influenza vaccination rates.

Science.gov (United States)

Lau, Annie Y S; Sintchenko, Vitali; Crimmins, Jacinta; Magrabi, Farah; Gallego, Blanca; Coiera, Enrico

2012-04-02

Online social networking and personally controlled health management systems (PCHMS) offer a new opportunity for developing innovative interventions to prevent diseases of public health concern (e.g., influenza) but there are few comparative studies about patterns of use and impact of these systems. A 2010 CONSORT-compliant randomised controlled trial with a two-group parallel design will assess the efficacy of a web-based PCHMS called Healthy.me in facilitating the uptake of influenza vaccine amongst university students and staff. Eligible participants are randomised either to obtain access to Healthy.me or a 6-month waitlist. Participants complete pre-study, post-study and monthly surveys about their health and utilisation of health services. A post-study clinical audit will be conducted to validate self-reports about influenza vaccination and visits to the university health service due to influenza-like illness (ILI) amongst a subset of participants. 600 participants older than 18 years with monthly access to the Internet and email will be recruited. Participants who (i) discontinue the online registration process; (ii) report obtaining an influenza vaccination in 2010 before the commencement of the study; or (iii) report being influenced by other participants to undertake influenza vaccination will be excluded from analysis. The primary outcome measure is the number of participants obtaining influenza vaccination during the study. Secondary outcome measures include: number of participants (i) experiencing ILI symptoms, (ii) absent from or experiencing impairment in work or study due to ILI symptoms, (iii) using health services or medications due to ILI symptoms; (iv) expressing positive or negative attitudes or experiences towards influenza vaccination, via their reasons of receiving (or not receiving) influenza vaccine; and (v) their patterns of usage of Healthy.me (e.g., frequency and timing of hits, duration of access, uptake of specific functions). This

Calling at the highway: The spatiotemporal constraint of road noise on Pacific chorus frog communication.

Science.gov (United States)

Nelson, Danielle V; Klinck, Holger; Carbaugh-Rutland, Alexander; Mathis, Codey L; Morzillo, Anita T; Garcia, Tiffany S

2017-01-01

Loss of acoustic habitat due to anthropogenic noise is a key environmental stressor for vocal amphibian species, a taxonomic group that is experiencing global population declines. The Pacific chorus frog ( Pseudacris regilla ) is the most common vocal species of the Pacific Northwest and can occupy human-dominated habitat types, including agricultural and urban wetlands. This species is exposed to anthropogenic noise, which can interfere with vocalizations during the breeding season. We hypothesized that Pacific chorus frogs would alter the spatial and temporal structure of their breeding vocalizations in response to road noise, a widespread anthropogenic stressor. We compared Pacific chorus frog call structure and ambient road noise levels along a gradient of road noise exposures in the Willamette Valley, Oregon, USA. We used both passive acoustic monitoring and directional recordings to determine source level (i.e., amplitude or volume), dominant frequency (i.e., pitch), call duration, and call rate of individual frogs and to quantify ambient road noise levels. Pacific chorus frogs were unable to change their vocalizations to compensate for road noise. A model of the active space and time ("spatiotemporal communication") over which a Pacific chorus frog vocalization could be heard revealed that in high-noise habitats, spatiotemporal communication was drastically reduced for an individual. This may have implications for the reproductive success of this species, which relies on specific call repertoires to portray relative fitness and attract mates. Using the acoustic call parameters defined by this study (frequency, source level, call rate, and call duration), we developed a simplified model of acoustic communication space-time for this species. This model can be used in combination with models that determine the insertion loss for various acoustic barriers to define the impact of anthropogenic noise on the radius of communication in threatened species

Make a 21st century phone call

CERN Multimedia

Katarina Anthony

2014-01-01

Want to avoid roaming charges? Click to call anyone at CERN? How about merging your CERN landline with your existing smartphone? That's all easily done with Lync, CERN's new opt-in service that can take your calls to the next level.   The Lync application on Windows (left) and iPhone (right). Lync unites CERN's traditional telephone service with the digital sphere. "Lync gives you the gift of mobility, by letting you access your CERN landline on the go," explains Pawel Grzywaczewski, service manager of the Lync system. "Once you've registered your CERN telephone with the service, you can run the Lync application and make calls from a range of supported devices. No matter where you are in the world - be it simply out to lunch or off at an international conference - you can make a CERN call as though you were in the office. All you need is an Internet connection!" Following a recent upgrade, CERN's Lync service now has...

Notes from the field: calls to poison centers for exposures to electronic cigarettes--United States, September 2010-February 2014.

Science.gov (United States)

Chatham-Stephens, Kevin; Law, Royal; Taylor, Ethel; Melstrom, Paul; Bunnell, Rebecca; Wang, Baoguang; Apelberg, Benjamin; Schier, Joshua G

2014-04-04

Electronic nicotine delivery devices such as electronic cigarettes (e-cigarettes) are battery-powered devices that deliver nicotine, flavorings (e.g., fruit, mint, and chocolate), and other chemicals via an inhaled aerosol. E-cigarettes that are marketed without a therapeutic claim by the product manufacturer are currently not regulated by the Food and Drug Administration (FDA). In many states, there are no restrictions on the sale of e-cigarettes to minors. Although e-cigarette use is increasing among U.S. adolescents and adults, its overall impact on public health remains unclear. One area of concern is the potential of e-cigarettes to cause acute nicotine toxicity. To assess the frequency of exposures to e-cigarettes and characterize the reported adverse health effects associated with e-cigarettes, CDC analyzed data on calls to U.S. poison centers (PCs) about human exposures to e-cigarettes (exposure calls) for the period September 2010 (when new, unique codes were added specifically for capturing e-cigarette calls) through February 2014. To provide a comparison to a conventional product with known toxicity, the number and characteristics of e-cigarette exposure calls were compared with those of conventional tobacco cigarette exposure calls.

Study of neurontin: titrate to effect, profile of safety (STEPS) trial: a narrative account of a gabapentin seeding trial.

Science.gov (United States)

Krumholz, Samuel D; Egilman, David S; Ross, Joseph S

2011-06-27

Seeding trials, clinical studies conducted by pharmaceutical companies for marketing purposes, have rarely been described in detail. We examined all documents relating to the clinical trial Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS) produced during the Neurontin marketing, sales practices, and product liability litigation, including company internal and external correspondence, reports, and presentations, as well as depositions elicited in legal proceedings of Harden Manufacturing vs Pfizer and Franklin vs Warner-Lambert, most which were created between 1990 and 2009. Using a systematic search strategy, we identified and reviewed all documents related to the STEPS trial in order to identify key themes related to the trial's conduct and determine the extent of marketing involvement in its planning and implementation. Documents demonstrated that STEPS was a seeding trial posing as a legitimate scientific study. Documents consistently described the trial itself, not trial results, to be a marketing tactic in the company's marketing plans. Documents demonstrated that at least 2 external sources questioned the validity of the study before execution, and that data quality during the study was often compromised. Furthermore, documents described company analyses examining the impact of participating as a STEPS investigator on rates and dosages of gabapentin prescribing, finding a positive association. None of these findings were reported in 2 published articles. The STEPS trial was a seeding trial, used to promote gabapentin and increase prescribing among investigators, and marketing was extensively involved in its planning and implementation.

Evaluation of a group based cognitive behavioural therapy programme for menstrual pain management in young women with intellectual disabilities: protocol for a mixed methods controlled clinical trial

Science.gov (United States)

2014-01-01

Background Menstrual pain which is severe enough to impact on daily activities is very common amongst menstruating females. Research suggests that menstrual pain which impacts on daily functioning may be even more prevalent amongst those with intellectual disabilities. Despite this, little research attention has focused on pain management programmes for those with intellectual disabilities. The aims of this pilot study were to develop and evaluate a theory-based cognitive behavioural therapy (CBT) programme for menstrual pain management in young women with intellectual disabilities. Methods/Design The study utilised a mixed methods controlled clinical trial to evaluate elements from a CBT programme called Feeling Better (McGuire & McManus, 2010). The Feeling Better programme is a modular, manualised intervention designed for people with an intellectual disability and their carers. The programme was delivered to 36 young women aged 12 – 30 years who have a Mild - Moderate Intellectual Disability, split between two conditions. The treatment group received the Feeling Better intervention and the control group received treatment as usual. To evaluate the effectiveness of the programme, measures were taken of key pain variables including impact, knowledge, self-efficacy and coping. Process evaluation was conducted to examine which elements of the programme were most successful in promoting change. Discussion Participants in the intervention group were expected to report the use of a greater number of coping strategies and have greater knowledge of pain management strategies following participation in the intervention and at three month follow-up, when compared to control group participants. A significant advantage of the study was the use of mixed methods and inclusion of process evaluation to determine which elements of a cognitive behavioural therapy programme work best for individuals with intellectual disabilities. Trial registration Current Controlled Trials

Sleep Quality of Call Handlers Employed in International Call Centers in National Capital Region of Delhi, India

Directory of Open Access Journals (Sweden)

JD Raja

2016-10-01

suspicion of insomnia or suspected insomnia; the rest had no sleep problem. Smoking, poor social support, heavy workload, lack of relaxation facility at office, and prolonged travel time to office were independent predictors of sleep quality (p<0.05. Conclusion: Call handlers have to compromise upon their sleep owing to the contemporary work settings in call centers. Safeguarding their health becomes an occupational health challenge to public health specialists.

Consumer Experiences Calling Toll-Free Corporate Hotlines.

Science.gov (United States)

Martin, Charles L.; Smart, Denise T.

1994-01-01

Finds that dimensions that contribute to caller satisfaction (of toll-free corporate hotlines) included operator characteristics such as knowledge, courtesy, and interest; specific behaviors such as apologizing for a problem, thanking the consumer for calling, and encouraging them to call again; and reducing time placed on "hold." (SR)

Leveraging microfinance to impact HIV and financial behaviors among adolescents and their mothers in West Bengal: a cluster randomized trial.

Science.gov (United States)

Spielberg, Freya; Crookston, Benjamin T; Chanani, Sheila; Kim, Jaewhan; Kline, Sean; Gray, Bobbi L

2013-01-01

Microfinance can be used to reach women and adolescent girls with HIV prevention education. We report findings from a cluster-randomized control trial among 55 villages in West Bengal to determine the impact of non-formal education on knowledge, attitudes and behaviors for HIV prevention and savings. Multilevel regression models were used to evaluate differences between groups for key outcomes while adjusting for cluster correlation and differences in baseline characteristics. Women and girls who received HIV education showed significant gains in HIV knowledge, awareness that condoms can prevent HIV, self-efficacy for HIV prevention, and confirmed use of clean needles, as compared to the control group. Condom use was rare and did not improve for women. While HIV testing was uncommon, knowledge of HIV-testing resources significantly increased among girls, and trended in the positive direction among women in intervention groups. Conversely, the savings education showed no impact on financial knowledge or behavior change.

GPON FTTH trial: lessons learned

Science.gov (United States)

Weis, Erik; Hölzl, Rainer; Breuer, Dirk; Lange, Christoph

2009-11-01

This paper reports on a FTTH field trial with GPON (Gigabit-capable passive optical network) technology in the network of Deutsche Telekom in the region of the cities of Berlin and Potsdam. Focus of this trial was to gain practical experience regarding GPON technology, fibre installation in existing ducts with micro duct technology, fibre cabling in customer buildings and impact on operational processes. Furthermore it is reported on an initial Deutsche Telekom FTTB deployment based on GPON technology in the city of Dresden with the main targets to obtain practical deployment and operation experiences with fibre-based access networks and to provide broadband access to a part of the city formerly not servable by DSL (digital subscriber line) technology.

Advertisement call of Scinax camposseabrai (Bokermann, 1968) (Anura: Hylidae), with comments on the call of three species of the Scinax ruber clade.

Science.gov (United States)

Novaes, Gabriel; Zina, Juliana

2016-02-25

Scinax camposseabrai was allocated into the Scinax ruber clade by Caramaschi & Cardoso (2006) by overall similarities as snout not pointed, breeding in open areas, and an advertisement calls with multipulsed notes. This assumption about the call was based solely on an onomatopoeia provided by Bokermann (1968). Herein we provide a formal description of the advertisement call of S. camposseabrai and compare it with described calls of other S. ruber clade species. Additionally, we provide descriptions of the advertisement calls of three sympatric species of the S. ruber clade: S. eurydice (Bokermann), S. pachycrus (Miranda-Ribeiro) and S. cf. x-signatus.

Impact of tracheal cuff shape on microaspiration of gastric contents in intubated critically ill patients: study protocol for a randomized controlled trial.

Science.gov (United States)

Jaillette, Emmanuelle; Brunin, Guillaume; Girault, Christophe; Zerimech, Farid; Chiche, Arnaud; Broucqsault-Dedrie, Céline; Fayolle, Cyril; Minacori, Franck; Alves, Isabelle; Barrailler, Stephanie; Robriquet, Laurent; Tamion, Fabienne; Delaporte, Emmanuel; Thellier, Damien; Delcourte, Claire; Duhamel, Alain; Nseir, Saad

2015-09-25

Ventilator-associated pneumonia (VAP) is the most common infection in intubated critically ill patients. Microaspiration of the contaminated gastric and oropharyngeal secretions is the main mechanism involved in the pathophysiology of VAP. Tracheal cuff plays an important role in stopping the progression of contaminated secretions into the lower respiratory tract. Previous in vitro studies suggested that conical cuff shape might be helpful in improving tracheal sealing. However, clinical studies found conflicting results. The aim of this study is to determine the impact of conical tracheal cuff shape on the microaspiration of gastric contents in critically ill patients. This prospective cluster randomized controlled crossover open-label trial is currently being conducted in ten French intensive care units (ICUs). Patients are allocated to intubation with a polyvinyl chloride (PVC) standard (barrel)-shaped or a PVC conical-shaped tracheal tube. The primary objective is to determine the impact of the conical shaped tracheal cuff on abundant microaspiration of gastric contents. Secondary outcomes include the incidence of microaspiration of oropharyngeal secretions, tracheobronchial colonization, VAP and ventilator-associated events. Abundant microaspiration is defined as the presence of pepsin at significant level (>200 ng/ml) in at least 30 % of the tracheal aspirates. Pepsin and amylase are quantitatively measured in all tracheal aspirates during the 48 h following inclusion. Quantitative tracheal aspirate culture is performed at inclusion and twice weekly. We plan to recruit 312 patients in the participating ICUs. BEST Cuff is the first randomized controlled study evaluating the impact of PVC tracheal-cuff shape on gastric microaspirations in patients receiving invasive mechanical ventilation. Enrollment began in June 2014 and is expected to end in October 2015. ClinicalTrials.gov Identifier: NCT01948635 (registered 31 August 2013).

The Influence of Peers During Adolescence: Does Homophobic Name Calling by Peers Change Gender Identity?

Science.gov (United States)

DeLay, Dawn; Lynn Martin, Carol; Cook, Rachel E; Hanish, Laura D

2018-03-01

Adolescents actively evaluate their identities during adolescence, and one of the most salient and central identities for youth concerns their gender identity. Experiences with peers may inform gender identity. Unfortunately, many youth experience homophobic name calling, a form of peer victimization, and it is unknown whether youth internalize these peer messages and how these messages might influence gender identity. The goal of the present study was to assess the role of homophobic name calling on changes over the course of an academic year in adolescents' gender identity. Specifically, this study extends the literature using a new conceptualization and measure of gender identity that involves assessing how similar adolescents feel to both their own- and other-gender peers and, by employing longitudinal social network analyses, provides a rigorous analytic assessment of the impact of homophobic name calling on changes in these two dimensions of gender identity. Symbolic interaction perspectives-the "looking glass self"-suggest that peer feedback is incorporated into the self-concept. The current study tests this hypothesis by determining if adolescents respond to homophobic name calling by revising their self-view, specifically, how the self is viewed in relation to both gender groups. Participants were 299 6th grade students (53% female). Participants reported peer relationships, experiences of homophobic name calling, and gender identity (i.e., similarity to own- and other-gender peers). Longitudinal social network analyses revealed that homophobic name calling early in the school year predicted changes in gender identity over time. The results support the "looking glass self" hypothesis: experiencing homophobic name calling predicted identifying significantly less with own-gender peers and marginally more with other-gender peers over the course of an academic year. The effects held after controlling for participant characteristics (e.g., gender), social

Attitude of Farmers towards Kisan Call Centres

Directory of Open Access Journals (Sweden)

Shely Mary Koshy

2017-09-01

Full Text Available The present study was conducted to measure the attitude of farmers in Kerala, India towards Kisan Call Centre (KCC. Kisan Call Centre provides free agricultural advisory services to every citizen involved in agriculture through a toll free number. One hundred and fifty farmers who have utilized the Kisan Call Centre service were selected from the database of KCC. The results showed that the respondents had moderately favourable attitude towards KCC followed by highly favourable attitude. The variables digital divide, temporal awareness on KCC, satisfaction towards KCC and utilization of KCC were found to have a positive correlation with the attitude of respondents towards KCC.

Partitioning a call graph

NARCIS (Netherlands)

Bisseling, R.H.; Byrka, J.; Cerav-Erbas, S.; Gvozdenovic, N.; Lorenz, M.; Pendavingh, R.A.; Reeves, C.; Röger, M.; Verhoeven, A.; Berg, van den J.B.; Bhulai, S.; Hulshof, J.; Koole, G.; Quant, C.; Williams, J.F.

2006-01-01

Splitting a large software system into smaller and more manageable units has become an important problem for many organizations. The basic structure of a software system is given by a directed graph with vertices representing the programs of the system and arcs representing calls from one program to

Too close to call

DEFF Research Database (Denmark)

Kurrild-Klitgaard, Peter

2012-01-01

a number of other frequent explanations and is found to be quite robust. When augmented with approval ratings for incumbent presidents, the explanatory power increases to 83 pct. and only incorrectly calls one of the last 15 US presidential elections. Applied to the 2012 election as a forecasting model...

A call for surveys

DEFF Research Database (Denmark)

Bernstein, Philip A.; Jensen, Christian S.; Tan, Kian-Lee

2012-01-01

The database field is experiencing an increasing need for survey papers. We call on more researchers to set aside time for this important writing activity. The database field is growing in population, scope of topics covered, and the number of papers published. Each year, thousands of new papers ...

Call centers with a postponed callback offer

NARCIS (Netherlands)

B. Legros (Benjamin); S. Ding (Sihan); R.D. van der Mei (Rob); O. Jouini (Oualid)

2017-01-01

textabstractWe study a call center model with a postponed callback option. A customer at the head of the queue whose elapsed waiting time achieves a given threshold receives a voice message mentioning the option to be called back later. This callback option differs from the traditional ones found in

The Dose-Response Relationship Between Tobacco Education Advertising and Calls to Quitlines in the United States, March-June, 2012.

Science.gov (United States)

Davis, Kevin C; Alexander, Robert L; Shafer, Paul; Mann, Nathan; Malarcher, Ann; Zhang, Lei

2015-11-05

We estimated changes in call volume in the United States in response to increases in advertising doses of the Tips From Former Smokers (Tips) campaign, the first federal national tobacco education campaign, which aired for 12 weeks from March 19 to June 10, 2012. We also measured the effectiveness of ad taglines that promoted calls directly with a quitline number (1-800-QUIT-NOW) and indirectly with a cessation help website (Smokefree.gov). Multivariate regressions estimated the weekly number of calls to 1-800-QUIT-NOW by area code as a function of weekly market-level gross rating points (GRPs) from CDC's Tips campaign in 2012. The number of quitline calls attributable solely to Tips was predicted. For quitline-tagged ads, an additional 100 television GRPs per week was associated with an increase of 89 calls per week in a typical area code in the United States (P advertising GRPs for ads tagged with Smokefree.gov was associated with an increase of 29 calls per week in any given area code (P < .001). We estimated that the Tips campaign was responsible for more than 170,000 additional calls to 1-800-QUIT-NOW during the campaign and that it would have generated approximately 140,000 additional calls if all ads were tagged with 1-800-QUIT-NOW. For campaign planners, these results make it possible to estimate 1) the likely impact of tobacco prevention media buys and 2) the additional quitline capacity needed at the national level should future campaigns of similar scale use 1-800-QUIT-NOW taglines exclusively.

IMPACT OF CLINICAL-TRIALS ON THE ADOPTION OF NEW DRUGS WITHIN A UNIVERSITY HOSPITAL

NARCIS (Netherlands)

DENIG, P; HAAIJER-RUSKAMP, FM; WESSELING, H

1991-01-01

To assess the influence that clinical trials may have on the introduction of new drugs into prescribing routines, the adoption of drugs has been studied in a university hospital in the Netherlands. A significant relation was found between the testing of semi-innovative drugs in clinical trials in

Therapeutic misconception in clinical trials: fighting against it and living with it.

Science.gov (United States)

Dal-Ré, R; Morell, F; Tejedor, J C; Gracia, D

2014-11-01

A clinical trial seeks information for the benefit of future patients and not necessarily for those who participate in the study. However, there are patients who believe that they will receive a direct therapeutic benefit by participating in a clinical trial, the so-called «therapeutic misconception». In this article, we describe the nature and extent of therapeutic misconception, which researchers can also experience. Its presence is especially important in phase 1 oncology trials and those with placebo group. To limit its occurrence, investigators have to ensure that participant information sheet are well written and to establish an effective and transparent discussion during the process of obtaining informed consent so that patients understand all aspects of their participation in the research and appreciate what this participation entails. Copyright © 2014 Elsevier España, S.L.U. All rights reserved.

A tale of harm, waste and deception: how big pharma has undermined public faith in trial data disclosure and what we can do about it

Directory of Open Access Journals (Sweden)

Vivienne C. Bachelet

2013-05-01

Full Text Available The article addresses the issue of data stemming from interventional studies in humans conducted by the pharmaceutical industry and how lack of data, or data distortion, can impact on clinical decision making and systematic reviews. The cases of rosiglitazone (Avandia ™, GlaxoSmithKline, rofecoxib (Vioxx ™, Merck, and oseltamivir (Tamiflu ™, Roche, are discussed as examples of harm (morbidity and mortality were higher in the treatment groups, waste (government spending in public health programs was not based on evidence, and deception (non-reporting of adverse events in fase III trials. The consequences of this behavior on scientific production are manifold. Most importantly, evidence that is used to inform clinical decisions is reduced and distorted, which also includes publication bias. The article mentions several solutions that have appeared in international literature, such as registration of clinical trials prior to implementation, the use of guidelines to improve the quality of reports, encouraging the publication of all research results and safeguarding autonomy of academy and investigators. Registration of clinical trials has not been effective in preventing the opacity surrounding phase III intervention trials funded by industry. Editors of biomedical journals, health authorities in charge of approving drugs before marketing, ethics committees that authorize the conduct of trials in their facilities, researchers, academics and patient organizations, are all major stakeholders. The pharmaceutical industry is called upon to respond to these proposals that promote transparency. If they do so, public trust in research conducted by them may be recovered.

Low velocity impact on polymer composite plates in contact with water

Directory of Open Access Journals (Sweden)

Y Kwon

2016-09-01

Full Text Available In this study, composite materials were tested in two different environments to determine the role of Fluid Structure Interaction with composites under a low velocity impact. This was done using a low velocity impact machine and polymer composite plates. The composite is made of laminated symmetrical plain weave E-glass fabrics. The test area of the composite plates is 30.5 cm by 30.5 cm with clamped boundary conditions. The testing was done using a drop weight system to impact the center of the test area. One testing was performed with composite plates in air, called dry impact. The other testing was conducted while composite plates were submerged in water, called wet impact. A Plexiglas box in conjunction with the impact machine was used to keep the top of the composite sample dry while it was submerged in an anechoic water tank, so called water-backed air impact. Output from the tests was recorded using strain gauges and a force impact sensor. The results show that an added mass effect from the water plays a large role in the Fluid Structure Interaction with composites due to the similar densities of water and the composites. The wet impact results in a larger impact force and damage than the dry impact under the same impact condition, i.e., the same impact mass and drop height.

The Role of Analyst Conference Calls in Capital Markets

NARCIS (Netherlands)

E.M. Roelofsen (Erik)

2010-01-01

textabstractMany firms conduct a conference call with analysts shortly after the quarterly earnings announcement. In these calls, management discusses the completed quarter, and analysts can ask questions. Due to SEC requirements, conference calls in the United States are virtually always live

Intradialytic parenteral nutrition in maintenance hemodialysis patients suffering from protein-energy wasting. Results of a multicenter, open, prospective, randomized trial.

Science.gov (United States)

Marsen, Tobias A; Beer, Justinus; Mann, Helmut

2017-02-01

Protein-energy wasting (PEW) is increasingly becoming a clinical problem in maintenance hemodialysis patients and guidelines call for nutritional interventions. Serum prealbumin (transthyretin) represents a critical nutritional marker positively correlated with patient survival and negatively correlated with morbidity. Nutritional counseling, oral supplementation as well as intradialytic parenteral nutrition (IDPN) are recommended to fight PEW, however clinical trials on their use are scarce. We conducted a prospective, multicenter, randomized, open-label, controlled, parallel-group Phase IV clinical trial in 107 maintenance hemodialysis patients suffering from PEW to assess the impact of IDPN on prealbumin and other biochemical and clinical parameters reflecting nutritional status. Patients randomized to the intervention group received standardized nutritional counseling plus IDPN three times weekly over 16 weeks followed by a treatment-free period of 12 weeks. The control group received standardized nutritional counseling only. Main trial inclusion criteria included moderate to severe malnutrition (SGA score B or C), maintenance hemodialysis therapy (3 times per week) for more than six months, and presence of two out of the following three criteria: albumin 30 mg/L at week 16 (48.7% vs. 31.8%). Prealbumin response to IDPN therapy was more prominent in patients suffering from moderate malnutrition (SGA score B) compared to patients with severe malnutrition (SGA score C). The results of this trial demonstrate for the first time that IDPN therapy, given three times weekly in a 16-week short-term intervention, results in a statistically significant and clinically relevant increase in mean serum prealbumin, a surrogate marker for outcome and survival in hemodialysis patients suffering from PEW, and is superior to nutritional counseling. Clinical trial registry:www.clinicaltrials.gov (NCT00501956). Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights

A randomized controlled Alzheimer's disease prevention trial's evolution into an exposure trial: the PREADViSE Trial.

Science.gov (United States)

Kryscio, R J; Abner, E L; Schmitt, F A; Goodman, P J; Mendiondo, M; Caban-Holt, A; Dennis, B C; Mathews, M; Klein, E A; Crowley, J J

2013-01-01

.0%) of the sites chose to participate in PREADViSE. Staff turnover at the sites presented challenges when training persons unfamiliar with cognitive testing procedures to conduct the memory screens. In the RCT few participants (1.6%) failed the MIS screen and among those who passed this screen a significant practice effect was encountered. In the exposure study 3,581 men were reached by phone in year 1, 15.7% could not be reached after 5 calls, and of those contacted 6.0% refused the screen even after consenting to the procedures at their clinical site. Most notable is that the failure rate for the MIS-T increased fourfold to 7.2%. Of the 257 men who took the TICS-M, 84.0% failed and were asked to contact their physicians for a more detailed memory assessment, and approximately half of these had some form of dementia or cognitive impairment. Several of these dementia cases are not AD. Partnering with SELECT led to an AD prevention trial conducted at a very reasonable cost by taking advantage of the experience and efficient clinical trial management found in a cancer cooperative group (Southwest Oncology Group or SWOG). Once unblinded, the RCT and exposure study data have the potential to yield new information on long term exposure to antioxidant supplements under controlled conditions.

Individual and contextual variation in Thomas langur male loud calls

NARCIS (Netherlands)

Wich, S.A.; Koski, S.; Vries, Han de; Schaik, Carel P. van

2003-01-01

Individual and contextual differences in male loud calls of wild Thomas langurs (Presbytis thomasi) were studied in northern Sumatra, Indonesia. Loud calls were given in the following contexts: morning calls, vocal responses to other groups, between-group encounter calls and alarmcalls. Loud

Cardio-metabolic and immunological impacts of extra virgin olive oil consumption in overweight and obese older adults: a randomized controlled trial.

Science.gov (United States)

Rozati, Mitra; Barnett, Junaidah; Wu, Dayong; Handelman, Garry; Saltzman, Edward; Wilson, Thomas; Li, Lijun; Wang, Junpeng; Marcos, Ascensión; Ordovás, José M; Lee, Yu-Chi; Meydani, Mohsen; Meydani, Simin Nikbin

2015-01-01

Both aging and obesity are related to dysregulated immune function, which may be responsible for increased risk of infection and also chronic non-infectious diseases. Dietary lipids have been shown to impact immune and inflammatory responses and cardio-metabolic risk factors. No information on the impact of olive oil on immune responses of overweight and obese older adults is available. We aimed to determine the effect of replacing oils used in a typical American diet with extra virgin olive oil for 3 months on immune responses and cardio-metabolic risk factors in overweight and obese older adults. This was a randomized, single-blinded and placebo-controlled trial in 41 overweight or obese participants (aged ≥ 65) who consumed a typical American diet. Participants in the control (CON, n = 21) group were provided with a mixture of corn, soybean oil and butter, and those in the olive oil (OO, n = 20) group, with extra virgin olive oil, to replace substitutable oils in their diet. At baseline and 3 months, we measured blood pressure, biochemical and immunological parameters using fasting blood, and delayed-type hypersensitivity (DTH) skin response. Compared to the CON group, the OO group showed decreased systolic blood pressure (P groups. Our results indicate that substitution of oils used in a typical American diet with extra virgin olive oil in overweight and obese older adults may have cardio-metabolic and immunological health benefits. This trial was registered at clinicaltrials.gov as NCT01903304.

Help Options in CALL: A Systematic Review

Science.gov (United States)

Cardenas-Claros, Monica S.; Gruba, Paul A.

2009-01-01

This paper is a systematic review of research investigating help options in the different language skills in computer-assisted language learning (CALL). In this review, emerging themes along with is-sues affecting help option research are identified and discussed. We argue that help options in CALL are application resources that do not only seem…

The Call to Teach and Teacher Hopefulness

Science.gov (United States)

Bullough, Robert V., Jr.; Hall-Kenyon, Kendra M.

2011-01-01

The purpose of this paper is to explore teacher motivation and well-being. Our analysis focuses on two central concepts, the notion of a "calling to teach" and of teacher "hopefulness." Data from 205 preservice and inservice teachers were collected to determine teachers' sense of calling and level of hope. Results indicate that overwhelmingly,…

Examining calling as a double-edged sword for employability

NARCIS (Netherlands)

Lysova, Evgenia I.; Jansen, Paul G.W.; Khapova, Svetlana N.; Plomp, Judith; Tims, Maria

2018-01-01

Using a two-study design (total N = 1232), this paper examines the relationship between calling and employability. We suggest that, on the one hand, calling can positively relate to employability due to individuals’ engagement in proactive professional development (PPD). On the other hand, calling

Single-Trial Event-Related Potential Based Rapid Image Triage System

Directory of Open Access Journals (Sweden)

Ke Yu

2011-06-01

Full Text Available Searching for points of interest (POI in large-volume imagery is a challenging problem with few good solutions. In this work, a neural engineering approach called rapid image triage (RIT which could offer about a ten-fold speed up in POI searching is developed. It is essentially a cortically-coupled computer vision technique, whereby the user is presented bursts of images at a speed of 6–15 images per second and then neural signals called event-related potential (ERP is used as the ‘cue’ for user seeing images of high relevance likelihood. Compared to past efforts, the implemented system has several unique features: (1 it applies overlapping frames in image chip preparation, to ensure rapid image triage performance; (2 a novel common spatial-temporal pattern (CSTP algorithm that makes use of both spatial and temporal patterns of ERP topography is proposed for high-accuracy single-trial ERP detection; (3 a weighted version of probabilistic support-vector-machine (SVM is used to address the inherent unbalanced nature of single-trial ERP detection for RIT. High accuracy, fast learning, and real-time capability of the developed system shown on 20 subjects demonstrate the feasibility of a brainmachine integrated rapid image triage system for fast detection of POI from large-volume imagery.

Rationale, design and methods for a randomised and controlled trial of the impact of virtual reality games on motor competence, physical activity, and mental health in children with developmental coordination disorder.

Science.gov (United States)

Straker, Leon M; Campbell, Amity C; Jensen, Lyn M; Metcalf, Deborah R; Smith, Anne J; Abbott, Rebecca A; Pollock, Clare M; Piek, Jan P

2011-08-18

A healthy start to life requires adequate motor development and physical activity participation. Currently 5-15% of children have impaired motor development without any obvious disorder. These children are at greater risk of obesity, musculoskeletal disorders, low social confidence and poor mental health. Traditional electronic game use may impact on motor development and physical activity creating a vicious cycle. However new virtual reality (VR) game interfaces may provide motor experiences that enhance motor development and lead to an increase in motor coordination and better physical activity and mental health outcomes. VR games are beginning to be used for rehabilitation, however there is no reported trial of the impact of these games on motor coordination in children with developmental coordination disorder. This cross-over randomised and controlled trial will examine whether motor coordination is enhanced by access to active electronic games and whether daily activity, attitudes to physical activity and mental health are also enhanced. Thirty children aged 10-12 years with poor motor coordination (≤ 15th percentile) will be recruited and randomised to a balanced ordering of 'no active electronic games' and 'active electronic games'. Each child will participate in both conditions for 16 weeks, and be assessed prior to participation and at the end of each condition. The primary outcome is motor coordination, assessed by kinematic and kinetic motion analysis laboratory measures. Physical activity and sedentary behaviour will be assessed by accelerometry, coordination in daily life by parent report questionnaire and attitudes to physical activity, self-confidence, anxiety and depressed mood will be assessed by self report questionnaire. A sample of 30 will provide a power of > 0.9 for detecting a 5 point difference in motor coordination on the MABC-2 TIS scale (mean 17, sd = 5). This is the first trial to examine the impact of new virtual reality games on

Initial data report in response to the surplus plutonium disposition environmental impact statement data call for the UO2 supply. Revision 1

International Nuclear Information System (INIS)

White, V.S.; Cash, J.M.; Michelhaugh, R.D.

1997-11-01

The purpose of this document is to support the US Department of Energy (DOE) Fissile Materials Disposition Program's preparation of the draft Surplus Plutonium Disposition Environmental Impact Statement. This is one of several responses to data calls generated to provide background information on activities associated with the operation of the Mixed-Oxide (MOX) Fuel Fabrication Facility. Urania feed for the MOX Fuel Fabrication Facility may be either natural or depleted. Natural uranium typically contains 0.0057 wt% 234 U, 0.711 wt% 235 U, and the majority as 238 U. The fissile isotope is 235 U, and uranium is considered depleted if the total 235 U content is less than 0.711 wt% as found in nature. The average composition of 235 U in DOE's total depleted urania inventory is 0.20 wt%. The depleted uranium assay range proposed for use in this program is 0.2500--0.2509 wt%. Approximately 30% more natural uranium would be required than depleted uranium based on the importance of maintaining a specific fissile portion in the MOX fuel blend. If the uranium component constitutes a larger quantity of fissile material, less plutonium can be dispositioned on an annual basis. The percentage composition, referred to as assay, of low-enriched uranium necessary for controlled fission in commercial light-water nuclear power reactors is 1.8--5.0 wt% 235 U. This data report provides information on the schedule, acquisition, impacts, and conversion process for using uranium, derived from depleted uranium hexafluoride (UF 6 ), as the diluent for the weapons-grade plutonium declared as surplus. The case analyzed is use of depleted UF 6 in storage at the Portsmouth Gaseous Diffusion Plant in Piketon, Ohio, being transported to a representative UF 6 to uranium dioxide conversion facility (GE Nuclear Energy) for processing, and subsequently transported to the MOX Fuel Fabrication Facility

Identification of sympatric bat species by the echolocation calls

Institute of Scientific and Technical Information of China (English)

2008-01-01

One hundred and thirty-eight echolocation calls of 63 free-flying individuals of five bat species (Rhinolophus ferrumequinum,Myotis formosus,Myotis ikonnikovi,Myotis daubentoni and Murina leucogaster)were recorded (by ultrasonic bat detector (D980)) in Zhi'an village of Jilin Province,China.According to the frequency-time spectra,these calls were categorized into two types:FM/CF (constant frequency) / FM (R.ferrumequinum) and FM (frequency modulated)(M.formosus,M.ikonnikovi,M.daubentoni and M.leucogaster).Sonograms of the calls of R.ferrumequinum could easily be distinguished from those of the other four species.For the calls of the remaining four species,six echolocation call parameters,including starting frequency,ending frequency,peak frequency duration,longest inter-pulse interval and shortest inter-pulse interval,were examined by stepwise discriminant analysis.The results show that 84.1% of calls were correctly classified,which indicates that these parameters of echolocation calls play an important role in identifying bat species.These parameters can be used to test the accuracy of general predictions based on bats' morphology in the same forest and can provide essential information for assessing patterns of bat habitat use.

Caring for the Caregiver: Identifying the Needs of Those Called to Care Through Partnerships with Congregations.

Science.gov (United States)

Galiatsatos, Panagis; Nelson, Katie; Hale, W Daniel

2017-06-01

As the older adult population continues to grow, the prevalence of chronic diseases is also increasing, leading to the need for novel ways of managing this large population of patients. One solution is to focus on informal caregivers. These informal caregivers already make a substantial contribution to our nation's healthcare finances and patient health outcomes. Caregivers also derive benefits from caring for their family member or friend; however, it is not uncommon for these individuals to experience negative health consequences, or what is often called "burden of care." Those called to care are not without their own burdens, and they must frequently make significant lifestyle adjustments that impact their own health. Therefore, for caregivers to be effective, caring for the caregivers must be a focus of medicine in the twenty-first century.

Clinical trials in Brazilian journals of ophthalmology: where we are.

Science.gov (United States)

Lira, Rodrigo Pessoa Cavalcanti; Leal, Franz Schubert; Gonçalves, Fauze Abdulmassih; Amorim, Fernando Henrique Ramos; Felix, João Paulo Fernandes; Arieta, Carlos Eduardo Leite

2013-01-01

To compare clinical trials published in Brazilian journals of ophthalmology and in foreign journals of ophthalmology with respect to the number of citations and the quality of reporting [by applying the Consolidated Standards for Reporting Trials (CONSORT) statement writing standards]. The sample of this systematic review comprised the two Brazilian journals of ophthalmology indexed at Science Citation Index Expanded and six of the foreign journals of ophthalmology with highest Impact Factor® according ISI. All clinical trials (CTs) published from January 2009 to December 2010 at the Brazilians journals and a 1:1 randomized sample of the foreign journals were included. The primary outcome was the number of citations through the end of 2011. Subgroup analysis included language. The secondary outcome included likelihood of citation (cited at least once versus no citation), and presence or absence of CONSORT statement indicators. The citation counts were statistically significantly higher (Pjournals of ophthalmology still are low when compared with the foreign journals of ophthalmology with highest Impact Factor®.

Impact of a targeted direct marketing price promotion intervention (Buywell) on food-purchasing behaviour by low income consumers: a randomised controlled trial.

Science.gov (United States)

Stead, M; MacKintosh, A M; Findlay, A; Sparks, L; Anderson, A S; Barton, K; Eadie, D

2017-08-01

Price promotions are a promising intervention for encouraging healthier food purchasing. We aimed to assess the impact of a targeted direct marketing price promotion combined with healthy eating advice and recipe suggestions on the purchase of selected healthier foods by low income consumers. We conducted a randomised controlled trial (n = 53 367) of a direct marketing price promotion (Buywell) combined with healthy eating advice and recipe suggestions for low income consumers identified as 'less healthy' shoppers. Impact was assessed using electronic point of sale data for UK low income shoppers before, during and after the promotion. The proportion of customers buying promoted products in the intervention month increased by between 1.4% and 2.8% for four of the five products. There was significantly higher uptake in the promotion month (P marketing price promotions combined with healthy eating advice and recipe suggestions targeted at low income consumers are feasible and can have a modest impact on short-term food-purchasing behaviour, although further approaches are needed to help sustain these changes. © 2017 The British Dietetic Association Ltd.

Using Getting To Outcomes to facilitate the use of an evidence-based practice in VA homeless programs: a cluster-randomized trial of an implementation support strategy.

Science.gov (United States)

Chinman, Matthew; McCarthy, Sharon; Hannah, Gordon; Byrne, Thomas Hugh; Smelson, David A

2017-03-09

Incorporating evidence-based integrated treatment for dual disorders into typical care settings has been challenging, especially among those serving Veterans who are homeless. This paper presents an evaluation of an effort to incorporate an evidence-based, dual disorder treatment called Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking-Veterans Edition (MISSION-Vet) into case management teams serving Veterans who are homeless, using an implementation strategy called Getting To Outcomes (GTO). This Hybrid Type III, cluster-randomized controlled trial assessed the impact of GTO over and above MISSION-Vet Implementation as Usual (IU). Both conditions received standard MISSION-Vet training and manuals. The GTO group received an implementation manual, training, technical assistance, and data feedback. The study occurred in teams at three large VA Medical Centers over 2 years. Within each team, existing sub-teams (case managers and Veterans they serve) were the clusters randomly assigned. The trial assessed MISSION-Vet services delivered and collected via administrative data and implementation barriers and facilitators, via semi-structured interview. No case managers in the IU group initiated MISSION-Vet while 68% in the GTO group did. Seven percent of Veterans with case managers in the GTO group received at least one MISSION-Vet session. Most case managers appreciated the MISSION-Vet materials and felt the GTO planning meetings supported using MISSION-Vet. Case manager interviews also showed that MISSION-Vet could be confusing; there was little involvement from leadership after their initial agreement to participate; the data feedback system had a number of difficulties; and case managers did not have the resources to implement all aspects of MISSION-Vet. This project shows that GTO-like support can help launch new practices but that multiple implementation facilitators are needed for successful execution of a complex evidence

Positive Impacts of Social Media at Work: Job Satisfaction, Job Calling, and Facebook Use among Co-Workers

Directory of Open Access Journals (Sweden)

Hanna Brittany

2017-01-01

Full Text Available The number of Facebook users grew rapidly since its conception. Within today’s workplace, employees are increasingly connecting with each other on Facebook for interpersonal reasons. Due to sensational reports by media outlets of inappropriate social media use, many organizations are taking extreme measures about how their employees who utilize Facebook to connect with colleagues. Contrary to the negative assumptions, McAfee [1] states that social media within the workplace can promote positive dynamics. The present study uses McAfee’s argument to examine if a positive connection exists between colleagues who use Facebook to connect with each other. An online survey with questions involving Facebook use with co-workers, job satisfaction, and perceived job calling was completed by employees (N=70 at two high-tech companies in Northern California, USA. Results revealed that job satisfaction is positively correlated with intensity of Facebook use among co-workers. Furthermore, feeling called to one’s line of work was statistically significantly higher for the group of employees who spent the most amount of time interacting on Facebook with their co-workers than the group that spent the least amount of time. These results suggest that companies could begin to explore the positive benefits of social media use within the workplace.

Calling under pressure: Short-finned pilot whales make social calls during deep foraging dives

DEFF Research Database (Denmark)

Jensen, Frants Havmand; Marrero Perez, Jacobo; Johnson, Mark

2011-01-01

Toothed whales rely on sound to echolocate prey and communicate with conspecifics, but little is known about how extreme pressure affects pneumatic sound production in deep-diving species with a limited air supply. The short-finned pilot whale (Globicephala macrorhynchus) is a highly social species...... among the deep-diving toothed whales, in which individuals socialize at the surface but leave their social group in pursuit of prey at depths of up to 1000 m. To investigate if these animals communicate acoustically at depth and test whether hydrostatic pressure affects communication signals, acoustic...... DTAGs logging sound, depth and orientation were attached to 12 pilot whales. Tagged whales produced tonal calls during deep foraging dives at depths of up to 800 m. Mean call output and duration decreased with depth despite the increased distance to conspecifics at the surface. This shows...

Impact of contact on adolescents’ mental health literacy and stigma: the SchoolSpace cluster randomised controlled trial

Science.gov (United States)

Chisholm, Katharine; Patterson, Paul; Torgerson, Carole; Turner, Erin; Jenkinson, David; Birchwood, Max

2016-01-01

Objectives To investigate whether intergroup contact in addition to education is more effective than education alone in reducing stigma of mental illness in adolescents. Design A pragmatic cluster randomised controlled trial compared education alone with education plus contact. Blocking was used to randomly stratify classes within schools to condition. Random allocation was concealed, generated by a computer algorithm, and undertaken after pretest. Data was collected at pretest and 2-week follow-up. Analyses use an intention-to-treat basis. Setting Secondary schools in Birmingham, UK. Participants The parents and guardians of all students in year 8 (age 12–13 years) were approached to take part. Interventions A 1-day educational programme in each school led by mental health professional staff. Students in the ‘contact’ condition received an interactive session with a young person with lived experience of mental illness. Outcomes The primary outcome was students’ attitudinal stigma of mental illness. Secondary outcomes included knowledge-based stigma, mental health literacy, emotional well-being and resilience, and help-seeking attitudes. Results Participants were recruited between 1 May 2011 and 30 April 2012. 769 participants completed the pretest and were randomised to condition. 657 (85%) provided follow-up data. At 2-week follow-up, attitudinal stigma improved in both conditions with no significant effect of condition (95% CI −0.40 to 0.22, p=0.5, d=0.01). Significant improvements were found in the education-alone condition compared with the contact and education condition for the secondary outcomes of knowledge-based stigma, mental health literacy, emotional well-being and resilience, and help-seeking attitudes. Conclusions Contact was found to reduce the impact of the intervention for a number of outcomes. Caution is advised before employing intergroup contact with younger student age groups. The education intervention appeared to be successful in

Research design considerations for single-dose analgesic clinical trials in acute pain

DEFF Research Database (Denmark)

Cooper, Stephen A; Desjardins, Paul J; Turk, Dennis C

2016-01-01

This article summarizes the results of a meeting convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) on key considerations and best practices governing the design of acute pain clinical trials. We discuss the role of early phase clinical trials......, including pharmacokinetic-pharmacodynamic (PK-PD) trials, and the value of including both placebo and active standards of comparison in acute pain trials. This article focuses on single-dose and short-duration trials with emphasis on the perioperative and study design factors that influence assay...... sensitivity. Recommendations are presented on assessment measures, study designs, and operational factors. Although most of the methodological advances have come from studies of postoperative pain after dental impaction, bunionectomy, and other surgeries, the design considerations discussed are applicable...

Identifying trial recruitment uncertainties using a James Lind Alliance Priority Setting Partnership - the PRioRiTy (Prioritising Recruitment in Randomised Trials) study.

Science.gov (United States)

Healy, Patricia; Galvin, Sandra; Williamson, Paula R; Treweek, Shaun; Whiting, Caroline; Maeso, Beccy; Bray, Christopher; Brocklehurst, Peter; Moloney, Mary Clarke; Douiri, Abdel; Gamble, Carrol; Gardner, Heidi R; Mitchell, Derick; Stewart, Derek; Jordan, Joan; O'Donnell, Martin; Clarke, Mike; Pavitt, Sue H; Guegan, Eleanor Woodford; Blatch-Jones, Amanda; Smith, Valerie; Reay, Hannah; Devane, Declan

2018-03-01

part of routine care and best utilise current clinical care pathways?" The top 10 research questions can be viewed at www.priorityresearch.ie . The prioritised questions call for a collective focus on normalising trials as part of clinical care, enhancing communication, addressing barriers, enablers and motivators around participation and exploring greater public involvement in the research process.

Frogs Call at a Higher Pitch in Traffic Noise

Directory of Open Access Journals (Sweden)

Kirsten M. Parris

2009-06-01

Full Text Available Male frogs call to attract females for mating and to defend territories from rival males. Female frogs of some species prefer lower-pitched calls, which indicate larger, more experienced males. Acoustic interference occurs when background noise reduces the active distance or the distance over which an acoustic signal can be detected. Birds are known to call at a higher pitch or frequency in urban noise, decreasing acoustic interference from low-frequency noise. Using Bayesian linear regression, we investigated the effect of traffic noise on the pitch of advertisement calls in two species of frogs, the southern brown tree frog (Litoria ewingii and the common eastern froglet (Crinia signifera. We found evidence that L. ewingii calls at a higher pitch in traffic noise, with an average increase in dominant frequency of 4.1 Hz/dB of traffic noise, and a total effect size of 123 Hz. This frequency shift is smaller than that observed in birds, but is still large enough to be detected by conspecific frogs and confer a significant benefit to the caller. Mathematical modelling predicted a 24% increase in the active distance of a L. ewingii call in traffic noise with a frequency shift of this size. Crinia signifera may also call at a higher pitch in traffic noise, but more data are required to be confident of this effect. Because frog calls are innate rather than learned, the frequency shift demonstrated by L. ewingii may represent an evolutionary adaptation to noisy conditions. The phenomenon of frogs calling at a higher pitch in traffic noise could therefore constitute an intriguing trade-off between audibility and attractiveness to potential mates.

New degradation call admission control for increasing WCDMA system capacity

Institute of Scientific and Technical Information of China (English)

Liu Ningqing; Lu Zhi; Gu Xuemai

2006-01-01

Propose a new degradation call admission control(DCAC)scheme, which can be used in wideband code division multiple access communication system. So-called degradation is that non-real time call has the characteristic of variable bit rate, so decreasing its bit rate can reduce the load of the system, consequently the system can admit new call which should be blocked when the system is close to full load, therefore new call's access probability increases. This paper brings forward design project and does system simulation, simulation proves that DCAC can effectively decrease calls' blocking probability and increase the total number of the on-line users.

Grey literature in meta-analyses of randomized trials of health care interventions.

Science.gov (United States)

Hopewell, S; McDonald, S; Clarke, M; Egger, M

2007-04-18

The inclusion of grey literature (i.e. literature that has not been formally published) in systematic reviews may help to overcome some of the problems of publication bias, which can arise due to the selective availability of data. To review systematically research studies, which have investigated the impact of grey literature in meta-analyses of randomized trials of health care interventions. We searched the Cochrane Methodology Register (The Cochrane Library Issue 3, 2005), MEDLINE (1966 to 20 May 2005), the Science Citation Index (June 2005) and contacted researchers who may have carried out relevant studies. A study was considered eligible for this review if it compared the effect of the inclusion and exclusion of grey literature on the results of a cohort of meta-analyses of randomized trials. Data were extracted from each report independently by two reviewers. The main outcome measure was an estimate of the impact of trials from the grey literature on the pooled effect estimates of the meta-analyses. Information was also collected on the area of health care, the number of meta-analyses, the number of trials, the number of trial participants, the year of publication of the trials, the language and country of publication of the trials, the number and type of grey and published literature, and methodological quality. Five studies met the inclusion criteria. All five studies showed that published trials showed an overall greater treatment effect than grey trials. This difference was statistically significant in one of the five studies. Data could be combined for three of the five studies. This showed that, on average, published trials showed a 9% greater treatment effect than grey trials (ratio of odds ratios for grey versus published trials 1.09; 95% CI 1.03-1.16). Overall there were more published trials included in the meta-analyses than grey trials (median 224 (IQR 108-365) versus 45(IQR 40-102)). Published trials had more participants on average. The most

The Role of Calling in Military Engagement

Science.gov (United States)

2017-06-01

depression , hopelessness, emotional and behavior problems , and have lower levels of neuroticism (Oladipo et al., 2013; Suldo & Huebner, 2004; Gilman...retention? Data from surveys of Naval Postgraduate School students reveal many work-related correlations with calling and calling’s positive effects. My...retention? Data from surveys of Naval Postgraduate School students reveal many work-related correlations with calling and calling’s positive effects

Adult meerkats modify close call rate in the presence of pups

Institute of Scientific and Technical Information of China (English)

Megan T.WYMAN; Pearl R.RIVERS; Coline MULLER; Pauline TONI; Marta B.MANSER

2017-01-01

In animals,signaling behavior is often context-dependent,with variation in the probability of emitting certain signals dependent on fitness advantages.Senders may adjust signaling rate depending on receiver identity,presence of audiences,or noise masking the signal,all of which can affect the benefits and costs of signal production.In the cooperative breeding meerkat Suricata suricatta,group members emit soft contact calls,termed as "close calls",while foraging in order to maintain group cohesion.Here,we investigated how the close calling rate during foraging was affected by the presence of pups,that produce continuous,noisy begging calls as they follow older group members.Adults decreased their overall close call rate substantially when pups were foraging with the group in comparison to periods when no pups were present.We suggest this decrease was likely due to a masking effect of the loud begging calls,which makes the close call function of maintaining group cohesion partly redundant as the centrally located begging calls can be used instead to maintain cohesion.There was some support that adults use close calls strategically to attract specific pups based on fitness advantages,that is,as the philopatric sex,females should call more than males and more to female pups than male pups.Dominant females called more than dominant males when a pup was in close proximity,while subordinates showed no sex-based differences.The sex of the nearest pup did not affect the calling rate of adults.The study shows that meerkats modify their close call production depending on benefits gained from calling and provides an example of the flexible use of one calling system in the presence of another,here contact calls versus begging calls,within the same species.