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Sample records for call trial impact

  1. Study protocol of the YOU CALL - WE CALL TRIAL: impact of a multimodal support intervention after a "mild" stroke

    Directory of Open Access Journals (Sweden)

    Bravo Gina

    2010-01-01

    Full Text Available Abstract Background More than 60% of new strokes each year are "mild" in severity and this proportion is expected to rise in the years to come. Within our current health care system those with "mild" stroke are typically discharged home within days, without further referral to health or rehabilitation services other than advice to see their family physician. Those with mild stroke often have limited access to support from health professionals with stroke-specific knowledge who would typically provide critical information on topics such as secondary stroke prevention, community reintegration, medication counselling and problem solving with regard to specific concerns that arise. Isolation and lack of knowledge may lead to a worsening of health problems including stroke recurrence and unnecessary and costly health care utilization. The purpose of this study is to assess the effectiveness, for individuals who experience a first "mild" stroke, of a sustainable, low cost, multimodal support intervention (comprising information, education and telephone support - "WE CALL" compared to a passive intervention (providing the name and phone number of a resource person available if they feel the need to - "YOU CALL", on two primary outcomes: unplanned-use of health services for negative events and quality of life. Method/Design We will recruit 384 adults who meet inclusion criteria for a first mild stroke across six Canadian sites. Baseline measures will be taken within the first month after stroke onset. Participants will be stratified according to comorbidity level and randomised to one of two groups: YOU CALL or WE CALL. Both interventions will be offered over a six months period. Primary outcomes include unplanned use of heath services for negative event (frequency calendar and quality of life (EQ-5D and Quality of Life Index. Secondary outcomes include participation level (LIFE-H, depression (Beck Depression Inventory II and use of health services for

  2. impact of queuing on call c queuing on call c queuing on call ...

    African Journals Online (AJOL)

    eobe

    work resource reduces the probability that a call arriving at the base sta formance evaluation plays an important role in modelling and network resource. network resource. This objective is achieved by an accurate traffic characte. This objective is achieved by an accurate traffic characte rformance metrics in terms of traffic ...

  3. Do post discharge phone calls improve care transitions? A cluster-randomized trial.

    Science.gov (United States)

    Soong, Christine; Kurabi, Bochra; Wells, David; Caines, Lesley; Morgan, Matthew W; Ramsden, Rebecca; Bell, Chaim M

    2014-01-01

    The transition from hospital to home can expose patients to adverse events during the post discharge period. Post discharge care including phone calls may provide support for patients returning home but the impact on care transitions is unknown. To examine the effect of a 72-hour post discharge phone call on the patient's transition of care experience. Cluster-randomized control trial. Urban, academic medical center. General medical patients age 18 and older discharged home after hospitalization. Primary outcome measure was the Care Transition Measure (CTM-3) score, a validated measure of the quality of care transitions. Secondary measures included self-reported adherence to medication and follow up plans, and 30-day composite of emergency department (ED) visits and hospital readmission. 328 patients were included in the study over an 6-month period. 114 (69%) received a post discharge phone call, and 214 of all patients in the study completed the follow outcome survey (65% response rate). A small difference in CTM-3 scores was observed between the intervention and control groups (1.87 points, 95% CI 0.47-3.27, p = 0.01). Self-reported adherence to treatment plans, ED visits, and emergency readmission rates were similar between the two groups (odds ratio 0.57, 95% CI 0.13-2.45, 1.20, 95% CI 0.61-2.37, and 1.18, 95% CI 0.53-2.61, respectively). A single post discharge phone call had a small impact on the quality of care transitions and no effect on hospital utilization. Higher intensity post discharge support may be required to improve the patient experience upon returning home. ClinicalTrials.gov NCT01580774.

  4. Do post discharge phone calls improve care transitions? A cluster-randomized trial.

    Directory of Open Access Journals (Sweden)

    Christine Soong

    Full Text Available The transition from hospital to home can expose patients to adverse events during the post discharge period. Post discharge care including phone calls may provide support for patients returning home but the impact on care transitions is unknown.To examine the effect of a 72-hour post discharge phone call on the patient's transition of care experience.Cluster-randomized control trial.Urban, academic medical center.General medical patients age 18 and older discharged home after hospitalization.Primary outcome measure was the Care Transition Measure (CTM-3 score, a validated measure of the quality of care transitions. Secondary measures included self-reported adherence to medication and follow up plans, and 30-day composite of emergency department (ED visits and hospital readmission.328 patients were included in the study over an 6-month period. 114 (69% received a post discharge phone call, and 214 of all patients in the study completed the follow outcome survey (65% response rate. A small difference in CTM-3 scores was observed between the intervention and control groups (1.87 points, 95% CI 0.47-3.27, p = 0.01. Self-reported adherence to treatment plans, ED visits, and emergency readmission rates were similar between the two groups (odds ratio 0.57, 95% CI 0.13-2.45, 1.20, 95% CI 0.61-2.37, and 1.18, 95% CI 0.53-2.61, respectively.A single post discharge phone call had a small impact on the quality of care transitions and no effect on hospital utilization. Higher intensity post discharge support may be required to improve the patient experience upon returning home.ClinicalTrials.gov NCT01580774.

  5. Randomized Trial of a Calling-Infused Career Workshop Incorporating Counselor Self-Disclosure

    Science.gov (United States)

    Dik, Bryan J.; Steger, Michael F.

    2008-01-01

    A randomized controlled trial was used to test (1) the efficacy of a two-session career development workshop for college student participants; (2) the effect of counselor self-disclosure on outcomes; and (3) the effect of infusing calling and vocation concepts on outcomes. Both standard (person-environment fit) and calling/vocation-infused…

  6. Impact of Using CALL on Iranian EFL Learners' Vocabulary Knowledge

    Science.gov (United States)

    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…

  7. Comparison of effects between home visits with telephone calls and telephone calls only for transitional discharge support: a randomised controlled trial.

    Science.gov (United States)

    Wong, Frances Kam Yuet; Chow, Susan Ka Yee; Chan, Tony Moon Fai; Tam, Stanley Kui Fu

    2014-01-01

    home visits and telephone calls are two often used approaches in transitional care but their differential effects are unknown. to examine the overall effects of a transitional care programme for discharged medical patients and the differential effects of telephone calls only. randomised controlled trial. a regional hospital in Hong Kong. patients discharged from medical units fitting the inclusion criteria (n = 610) were randomly assigned to: control ('control', n = 210), home visits with calls ('home', n = 196) and calls only ('call', n = 204). the home groups received alternative home visits and calls and the call groups calls only for 4 weeks. The control group received two placebo calls. The nurse case manager was supported by nursing students in delivering the interventions. the home visit group (after 4 weeks 10.7%, after 12 weeks 21.4%) and the call group (11.8, 20.6%) had lower readmission rates than the control group (17.6, 25.7%). Significance differences were detected in intention-to-treat (ITT) analysis for the home and intervention group (home and call combined) at 4 weeks. In the per-protocol analysis (PPA) results, significant differences were found in all groups at 4 weeks. There was significant improvement in quality of life, self-efficacy and satisfaction in both ITT and PPA for the study groups. this study has found that bundled interventions involving both home visits and calls are more effective in reducing readmissions. Many of the transitional care programmes use all-qualified nurses, and this study reveals that a mixed skills model seems to bring about positive effects as well.

  8. Impact of Queuing on Call Completion Rate in GSM Networks | Nkop ...

    African Journals Online (AJOL)

    In this paper, we use the queuing approach to develop a model for call completion, making signal power considerations as well. A General User Interface (GUI) is designed for the developed model using MATLAB and the impact of queuing on call completion is analysed by carrying out an assessment of the performance of ...

  9. Virtual house calls for Parkinson disease (Connect.Parkinson): study protocol for a randomized, controlled trial.

    Science.gov (United States)

    Achey, Meredith A; Beck, Christopher A; Beran, Denise B; Boyd, Cynthia M; Schmidt, Peter N; Willis, Allison W; Riggare, Sara S; Simone, Richard B; Biglan, Kevin M; Dorsey, E Ray

    2014-11-27

    Interest in improving care for the growing number of individuals with chronic conditions is rising. However, access to care is limited by distance, disability, and distribution of doctors. Small-scale studies in Parkinson disease, a prototypical chronic condition, have suggested that delivering care using video house calls is feasible, offers similar clinical outcomes to in-person care, and reduces travel burden. We are conducting a randomized comparative effectiveness study (Connect.Parkinson) comparing usual care in the community to usual care augmented by virtual house calls with a Parkinson disease specialist. Recruitment is completed centrally using online advertisements and emails and by contacting physicians, support groups, and allied health professionals. Efforts target areas with a high proportion of individuals not receiving care from neurologists. Approximately 200 individuals with Parkinson disease and their care partners will be enrolled at 20 centers throughout the United States and followed for one year. Participants receive educational materials, then are randomized in a 1:1 ratio to continue their usual care (control arm) or usual care and specialty care delivered virtually (intervention arm). Care partners are surveyed about their time and travel burden and their perceived caregiver burden. Participants are evaluated via electronic survey forms and videoconferencing with a blinded independent rater at baseline and at 12 months. All study activities are completed remotely.The primary outcomes are: (1) feasibility, as measured by the proportion of visits completed, and (2) quality of life, as measured by the 39-item Parkinson's Disease Questionnaire. Secondary outcomes include measures of clinical benefit, quality of care, time and travel burden, and caregiver burden. Connect.Parkinson will evaluate the feasibility and effectiveness of using technology to deliver care into the homes of individuals with Parkinson disease. The trial may serve as a

  10. National randomized controlled trial of virtual house calls for Parkinson disease.

    Science.gov (United States)

    Beck, Christopher A; Beran, Denise B; Biglan, Kevin M; Boyd, Cynthia M; Dorsey, E Ray; Schmidt, Peter N; Simone, Richard; Willis, Allison W; Galifianakis, Nicholas B; Katz, Maya; Tanner, Caroline M; Dodenhoff, Kristen; Aldred, Jason; Carter, Julie; Fraser, Andrew; Jimenez-Shahed, Joohi; Hunter, Christine; Spindler, Meredith; Reichwein, Suzanne; Mari, Zoltan; Dunlop, Becky; Morgan, John C; McLane, Dedi; Hickey, Patrick; Gauger, Lisa; Richard, Irene Hegeman; Mejia, Nicte I; Bwala, Grace; Nance, Martha; Shih, Ludy C; Singer, Carlos; Vargas-Parra, Silvia; Zadikoff, Cindy; Okon, Natalia; Feigin, Andrew; Ayan, Jean; Vaughan, Christina; Pahwa, Rajesh; Dhall, Rohit; Hassan, Anhar; DeMello, Steven; Riggare, Sara S; Wicks, Paul; Achey, Meredith A; Elson, Molly J; Goldenthal, Steven; Keenan, H Tait; Korn, Ryan; Schwarz, Heidi; Sharma, Saloni; Stevenson, E Anna; Zhu, William

    2017-09-12

    To determine whether providing remote neurologic care into the homes of people with Parkinson disease (PD) is feasible, beneficial, and valuable. In a 1-year randomized controlled trial, we compared usual care to usual care supplemented by 4 virtual visits via video conferencing from a remote specialist into patients' homes. Primary outcome measures were feasibility, as measured by the proportion who completed at least one virtual visit and the proportion of virtual visits completed on time; and efficacy, as measured by the change in the Parkinson's Disease Questionnaire-39, a quality of life scale. Secondary outcomes included quality of care, caregiver burden, and time and travel savings. A total of 927 individuals indicated interest, 210 were enrolled, and 195 were randomized. Participants had recently seen a specialist (73%) and were largely college-educated (73%) and white (96%). Ninety-five (98% of the intervention group) completed at least one virtual visit, and 91% of 388 virtual visits were completed. Quality of life did not improve in those receiving virtual house calls (0.3 points worse on a 100-point scale; 95% confidence interval [CI] -2.0 to 2.7 points; p = 0.78) nor did quality of care or caregiver burden. Each virtual house call saved patients a median of 88 minutes (95% CI 70-120; p < 0.0001) and 38 miles per visit (95% CI 36-56; p < 0.0001). Providing remote neurologic care directly into the homes of people with PD was feasible and was neither more nor less efficacious than usual in-person care. Virtual house calls generated great interest and provided substantial convenience. NCT02038959. This study provides Class III evidence that for patients with PD, virtual house calls from a neurologist are feasible and do not significantly change quality of life compared to in-person visits. The study is rated Class III because it was not possible to mask patients to visit type. © 2017 American Academy of Neurology.

  11. Calling the patient's own name facilitates recovery from general anaesthesia: a randomised double-blind trial.

    Science.gov (United States)

    Jung, Y S; Paik, H; Min, S-H; Choo, H; Seo, M; Bahk, J-H; Seo, J-H

    2017-02-01

    People can hear and pay attention to familiar terms such as their own name better than general terms, referred to as the cocktail party effect. We performed a prospective, randomised, double-blind trial to investigate whether calling the patient's name compared with a general term facilitated a patient's response and recovery from general anaesthesia. We enrolled women having breast cancer surgery with general anaesthesia using propofol and remifentanil. Patients were randomly allocated into two groups depending on whether the patient's name or a general term was called, followed by the verbal command - 'open your eyes!' - during emergence from anaesthesia; this pre-recorded sentence was played to the patient using headphones. Fifty patients were allocated to the name group and 51 to the control group. Our primary outcome was the time from discontinuation of anaesthesia until eye opening. The mean (SD) time was 337 (154) s in the name group and 404 (170) s in the control group (p = 0.041). The time to i-gel® removal was 385 (152) vs. 454 (173) s (p = 0.036), the time until achieving a bispectral index of 60 was 174 (133) vs. 205 (160) s (p = 0.3), and the length of stay in the postanaesthesia care unit was 43.8 (3.4) vs. 47.3 (7.1) min (p = 0.005), respectively. In conclusion, using the patient's name may be an easy and effective method to facilitate recovery from general anaesthesia. © 2016 The Association of Anaesthetists of Great Britain and Ireland.

  12. Road Impacts on Abundance, Call Traits, and Body Size of Rainforest Frogs in Northeast Australia

    Directory of Open Access Journals (Sweden)

    Conrad J. Hoskin

    2010-09-01

    Full Text Available Frogs are potentially sensitive indicators of road impacts, with studies indicating particular susceptibility to road mortality. Calling, i.e., breeding, behavior could also be affected by traffic noise. We investigated effects on frog abundance and calling behavior where a busy highway crosses rainforest stream breeding habitat in northeast Australia. Frog abundance was repeatedly surveyed along five stream transects during a summer breeding season. Abundance of two species, Litoria rheocola and Austrochaperina pluvialis, increased significantly with perpendicular distance from the road along two transects. No trends in abundance were detected for A. pluvialis on two other transects where it was common, or for Litoria serrata on one transect where abundance was sufficient for analysis. Both species with lowered abundance near the road, L. rheocola and A. pluvialis, are rare in road kill statistics along this highway, suggesting road mortality is not the cause of reduced frog abundance near the road. We postulate that lowered abundance may reflect traffic noise effects. We analyzed calls of the International Union for Conservation of Nature endangered species L. rheocola along the one stream transect on which it was common. We found significant trends in two call traits over a very fine scale: both call rate and dominant frequency were significantly higher closer to the road. Furthermore, males were significantly smaller closer to the road. These call and body size trends most likely reflect road impacts, but resolving these is complicated by correlations between traits. Potential mechanisms, effects on fitness, and management recommendations to mitigate the impacts of roads on frogs are outlined.

  13. Estimating inbreeding coefficients from NGS data: Impact on genotype calling and allele frequency estimation

    Science.gov (United States)

    Vieira, Filipe G.; Fumagalli, Matteo; Albrechtsen, Anders; Nielsen, Rasmus

    2013-01-01

    Most methods for next-generation sequencing (NGS) data analyses incorporate information regarding allele frequencies using the assumption of Hardy–Weinberg equilibrium (HWE) as a prior. However, many organisms including those that are domesticated, partially selfing, or with asexual life cycles show strong deviations from HWE. For such species, and specially for low-coverage data, it is necessary to obtain estimates of inbreeding coefficients (F) for each individual before calling genotypes. Here, we present two methods for estimating inbreeding coefficients from NGS data based on an expectation-maximization (EM) algorithm. We assess the impact of taking inbreeding into account when calling genotypes or estimating the site frequency spectrum (SFS), and demonstrate a marked increase in accuracy on low-coverage highly inbred samples. We demonstrate the applicability and efficacy of these methods in both simulated and real data sets. PMID:23950147

  14. Calls Forecast for the Moscow Ambulance Service. The Impact of Weather Forecast

    Science.gov (United States)

    Gordin, Vladimir; Bykov, Philipp

    2015-04-01

    We use the known statistics of the calls for the current and previous days to predict them for tomorrow and for the following days. We assume that this algorithm will work operatively, will cyclically update the available information and will move the horizon of the forecast. Sure, the accuracy of such forecasts depends on their lead time, and from a choice of some group of diagnoses. For comparison we used the error of the inertial forecast (tomorrow there will be the same number of calls as today). Our technology has demonstrated accuracy that is approximately two times better compared to the inertial forecast. We obtained the following result: the number of calls depends on the actual weather in the city as well as on its rate of change. We were interested in the accuracy of the forecast for 12-hour sum of the calls in real situations. We evaluate the impact of the meteorological errors [1] on the forecast errors of the number of Ambulance calls. The weather and the Ambulance calls number both have seasonal tendencies. Therefore, if we have medical information from one city only, we should separate the impacts of such predictors as "annual variations in the number of calls" and "weather". We need to consider the seasonal tendencies (associated, e. g. with the seasonal migration of the population) and the impact of the air temperature simultaneously, rather than sequentially. We forecasted separately the number of calls with diagnoses of cardiovascular group, where it was demonstrated the advantage of the forecasting method, when we use the maximum daily air temperature as a predictor. We have a chance to evaluate statistically the influence of meteorological factors on the dynamics of medical problems. In some cases it may be useful for understanding of the physiology of disease and possible treatment options. We can assimilate some personal archives of medical parameters for the individuals with concrete diseases and the relative meteorological archive. As a

  15. Improving Rates of Outpatient Influenza Vaccination Through EHR Portal Messages and Interactive Automated Calls: A Randomized Controlled Trial.

    Science.gov (United States)

    Cutrona, Sarah L; Golden, Jessica G; Goff, Sarah L; Ogarek, Jessica; Barton, Bruce; Fisher, Lloyd; Preusse, Peggy; Sundaresan, Devi; Garber, Lawrence; Mazor, Kathleen M

    2018-01-30

    Patient reminders for influenza vaccination, delivered via electronic health record (EHR) patient portal messages and interactive voice response (IVR) calls, offer an innovative approach to improving patient care. To test the effectiveness of portal and IVR outreach in improving rates of influenza vaccination. Randomized controlled trial of EHR portal messages and IVR calls promoting influenza vaccination. Adults with no documented influenza vaccination 2 months after the start of influenza season (2014-2015). Using a factorial design, we assigned 20,000 patients who were active portal users to one of four study arms: (a) receipt of a portal message promoting influenza vaccines, (b) receipt of IVR call with similar content, (c) both a and b, or (d) neither (usual care). We randomized 10,000 non-portal users to receipt of IVR call or usual care. In all intervention arms, information on pneumococcal vaccination was included if the targeted patient was overdue for pneumococcal vaccine. EHR-documented influenza vaccination during the 2014-2015 influenza season, measured April 2015. Among portal users, 14.0% (702) of those receiving both portal messages and calls, 13.4% (669) of message recipients, 12.8% (642) of call recipients, and 11.6% (582) of those with usual care received vaccines. On multivariable analysis of portal users, those receiving portal messages alone (OR 1.20, 95% CI 1.06-1.35) or IVR calls alone (OR 1.15 95% CI 1.02-1.30) were more likely than usual care recipients to be vaccinated. Those receiving both messages and calls were also more likely than the usual care group to be vaccinated (ad hoc analysis, using a Bonferroni correction: OR 1.29, 97.5% CI 1.13, 1.48). Among non-portal users, 8.5% of call recipients and 8.6% of usual care recipients received influenza vaccines (p = NS). Pneumococcal vaccination rates showed no significant improvement. Our outreach achieved a small but significant improvement in influenza vaccination rates. Registration

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

    Science.gov (United States)

    2014-01-01

    Background 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. Methods 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). Results 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 smoking (OR = 0.375; 95% CI = 0.217-0.645, P 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. Trial registration TCTR20140504001 PMID:24886549

  17. Targeted Reminder Phone Calls to Patients at High Risk of No-Show for Primary Care Appointment: A Randomized Trial.

    Science.gov (United States)

    Shah, Sachin J; Cronin, Patrick; Hong, Clemens S; Hwang, Andrew S; Ashburner, Jeffrey M; Bearnot, Benjamin I; Richardson, Calvin A; Fosburgh, Blair W; Kimball, Alexandra B

    2016-12-01

    No-shows, or missed appointments, are a problem for many medical practices. They result in fragmented care and reduce access for all patients. To determine whether telephone reminder calls targeted to patients at high risk of no-show can reduce no-show rates. Single-center randomized controlled trial. A total of 2247 primary care patients in a hospital-based primary care clinic at high risk of no-show (>15 % risk) for their appointment in 7 days. Seven days prior to their appointment, intervention arm patients were placed in a calling queue to receive a reminder phone call from a patient service coordinator. Coordinators were trained to engage patients in concrete planning. All patients received an automated phone call (usual care). Primary outcome was no-show rate. Secondary outcomes included arrival rate, cancellation rate, reschedule rate, time to cancellation, and change in revenue. The no-show rate in the intervention arm (22.8 %) was significantly lower (absolute risk difference -6.4 %, p phone call 7 days prior to an appointment led to a significant reduction in no-shows and increased reimbursement among patients at high risk of no-show. The use of targeted interventions may be of interest to practices taking on increased accountability for population health.

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

    Directory of Open Access Journals (Sweden)

    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.

  19. Frequency and Impact of Pharmacist Interventions in Clinical Trial Patients With Diabetes.

    Science.gov (United States)

    Martinez, Joe; Laswell, Emily; Cailor, Stephanie; Ballentine, Jeb

    2017-04-01

    The objective of this study was to describe the interventions and impact made by pharmacists during clinical trials. A specialty contract research organization that used clinical trial research pharmacists to communicate with patients to support clinical trial protocol adherence, retention, and health outcomes performed a retrospective, descriptive analysis of 12 clinical trials that involved 2 noninsulin glucose-lowering medications. Pharmacists called study participants at specific timepoints during the trials as per protocol. During each telephone call, the number and types of interventions were documented. Descriptive statistics (frequencies) were performed to determine the number and type of interventions by call and by patient across all noninsulin glucose-lowering medication drug A and drug B studies. Overall, 25,829 calls were made across all studies. Of these calls, 11,765 calls (45.5%) had at least one intervention that involved 3573 patients (92.3%). The most frequent interventions addressed adverse events (3774 [14.6%]), protocol violations for medication use (3341 [12.9%]), concurrent medications (1630 [5.9%]), and miscellaneous concerns (1269 [4.6%]). The greatest numbers of interventions were high-impact interventions (4772 [18.5%]) (eg, serious adverse events) that would seriously affect trial outcomes and patient adherence. Pharmacists were able to identify, support, and address multiple types of interventions related to medication management during clinical trials, including those related to concurrent medication use, adverse events, and other medication-related issues. These pharmacist interventions can result in better patient outcomes and, ultimately, more reliable study results for review and approval by regulatory agencies. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  20. Recruitment to mammography screening: a randomised trial and meta-analysis of invitation letters and telephone calls.

    Science.gov (United States)

    Page, Andrew; Morrell, Stephen; Chiu, Clayton; Taylor, Richard; Tewson, Richard

    2006-04-01

    To determine the effectiveness of three recruitment strategies to encourage women to attend for an initial mammography screen, and to compare results with similar service studies. Interventions were: (1) an invitation letter; (2) two invitation letters; and (3) an invitation letter plus a follow-up telephone call. All women aged 50-54 years in two BreastScreen New South Wales (BSNSW) Screening and Assessment Service catchment areas (n=3,144) were recruited from the Australian Electoral Roll and randomised to the four groups. Response rates for each intervention were compared relative to standard practice (one invitation letter) at 12-weeks follow-up. Marginal cost-effectiveness for each condition was calculated. Other similar randomised trials were also meta-analysed. The screening rate for two letters was 8.5% (OR=1.61, 95% CI 1.08-2.40) and 7.8% (OR=1.46, 95% CI 0.97-2.18) for one letter plus a telephone call, compared with 5.5% for standard practice (one letter) (OR=1.00). The response rate in the one letter plus a phone call group was 13.3% (OR=2.65, 95% CI 1.76-4.00) for women where a phone number was located. Initial screening rates after a 12-week follow-up were significantly higher in the women receiving a second invitation letter, compared with standard practice (one letter). Marginal cost-effectiveness favoured the two-letter approach. A follow-up invitation letter is more cost-effective than one invitation letter plus a follow-up telephone call in the BSNSW program. However, an invitation letter plus follow-up phone call is more cost-effective in recruiting women to BSNSW only if a phone number is located.

  1. McCall's Area Transformation versus the Integrated Impact Indicator (I3)

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    Leydesdorff, Loet

    2012-01-01

    In a study entitled "Skewed Citation Distributions and Bias Factors: Solutions to two core problems with the journal impact factor," Mutz & Daniel (2012) propose (i) McCall's (1922) Area Transformation of the skewed citation distribution so that this data can be considered as normally distributed (Krus & Kennedy, 1977), and (ii) to control for different document types as a co-variate (Rubin, 1977). This approach provides an alternative to Leydesdorff & Bornmann's (2011) Integrated Impact Indicator (I3). As the authors note, the two approaches are akin. Can something be said about the relative quality of the two approaches? To that end, I replicated the study of Mutz & Daniel for the 11 journals in the Subject Category "mathematical psychology," but using additionally I3 on the basis of continuous quantiles (Leydesdorff & Bornmann, in press) and its variant PR6 based on the six percentile rank classes distinguished by Bornmann & Mutz (2011) as follows: the top-1%, 95-99%, 90-95%, 75-90%...

  2. Impact of the chorus environment on temporal processing of advertisement calls by gray treefrogs

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    Schwartz, Joshua; Huth, Kenneth; Lasker, Jeffrey

    2004-05-01

    Male gray treefrogs advertise for mates using calls that consist of a series of pulses. Pulse duration, interpulse interval, and pulse shape determine whether a call is recognized as a conspecific signal by females. Females use call rate and call pulse number to assess relative calling performance by males, and prefer males that display high calling efforts. However, within choruses call overlap among males and background noise can compromise the ability of females to detect and correctly interpret temporal information in calls. Phonotaxis tests using calls suffering from different patterns of overlap or with internal gaps were used to investigate specific consequences of interference and masking as well as mechanisms that might alleviate such problems. Our data indicate that females do not employ a process analogous to phonemic restoration to ``fill in'' missing call segments; however, if a sufficient percent of call elements fall within species-specific ranges, females may ignore call anomalies. Additional findings are generally consistent with those from a recent study on anuran auditory midbrain neurons that count and indicate that inappropriate pulse intervals can reset the pulse counting process. [Work supported by NSF and a Pace University Eugene M. Lang Research Fellowship.

  3. 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.

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

    Science.gov (United States)

    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…

  5. Ambulance call-outs and response times in Birmingham and the impact of extreme weather and climate change.

    Science.gov (United States)

    Thornes, John Edward; Fisher, Paul Anthony; Rayment-Bishop, Tracy; Smith, Christopher

    2014-03-01

    Although there has been some research on the impact of extreme weather on the number of ambulance call-out incidents, especially heat waves, there has been very little research on the impact of cold weather on ambulance call-outs and response times. In the UK, there is a target response rate of 75% of life threatening incidents (Category A) that must be responded to within 8 min. This paper compares daily air temperature data with ambulance call-out data for Birmingham over a 5-year period (2007-2011). A significant relationship between extreme weather and increased ambulance call-out and response times can clearly be shown. Both hot and cold weather have a negative impact on response times. During the heat wave of August 2003, the number of ambulance call-outs increased by up to a third. In December 2010 (the coldest December for more than 100 years), the response rate fell below 50% for 3 days in a row (18 December-20 December 2010) with a mean response time of 15 min. For every reduction of air temperature by 1°C there was a reduction of 1.3% in performance. Improved weather forecasting and the take up of adaptation measures, such as the use of winter tyres, are suggested for consideration as management tools to improve ambulance response resilience during extreme weather. Also it is suggested that ambulance response times could be used as part of the syndromic surveillance system at the Health Protection Agency.

  6. 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], prespiratory physiotherapists' treatments respectively). Case-by-case, there were fewer clinically important improvements following non-respiratory physiotherapists' treatments compared with the respiratory physiotherapists' (n=27 [43%] versus n=40 [63%], p=0.03). Eleven adverse events occurred, eight following non-respiratory physiotherapists' treatments. Significant disparities exist in treatment outcomes when patients are treated by non-respiratory on-call physiotherapists, compared with specialist respiratory physiotherapists. There is an urgent need for targeted training strategies, or alternative service delivery models, to be explored. This should aim to address the quality of respiratory physiotherapy services, both during and outside of normal working hours. Clinicaltrials

  7. CARIAA Call - Call Document

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

    CARIAA

    2013-02-19

    Feb 19, 2013 ... Canada's International Development Research Centre (IDRC) is pleased to announce a call for concept notes as part of the Collaborative Adaptation Research Initiative in Africa and Asia (CARIAA) program. Funded by IDRC and the United Kingdom's Department for International Development (DFID), ...

  8. Impact of protected sleep period for internal medicine interns on overnight call on depression, burnout, and empathy.

    Science.gov (United States)

    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

    2014-06-01

    Patient safety and sleep experts advocate a protected sleep period for residents. 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. 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). 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 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.

  9. Impact of Hurricane Ike on the call volumes of Houston Fire Department emergency medical services.

    Science.gov (United States)

    Cooper, Elise; Langabeer, James R; Alqusairi, Diaa; Persse, David

    2012-01-01

    Little is known about the capacity and activity of emergency medical services (EMS) during large-scale disasters. This article provides a case study of the role of EMS in one large urban city during a major hurricane. The authors analyzed changes in call volume data from the City of Houston Fire Department's EMS during Hurricane Ike. Descriptive and statistical analyses are used to explain surges and statistical differences in volumes. Demand for EMS care can increase approximately 40 percent during surges in the disaster cycle, placing extreme burdens on system capacity and workload. The largest increase in demand came from respiratory problems, falls, and chest pains, with the largest decrease in calls from motor vehicle accidents. A strategy for managing surges in prehospital care from major disasters is a requirement for modern EMS.

  10. Wheels-Off Time Uncertainty Impact on Benefits of Early Call for Release Scheduling

    Science.gov (United States)

    Palopo, Kee; Chatterji, Gano B.; Almog, Noam

    2017-01-01

    Arrival traffic scenarios with 808 flights from 173 airports to Houston George Bush International airport are simulated to determine if Call For Release flights can receive a benefit in terms of less delay over other flights by scheduling prior to gate pushback (look-ahead in time) as opposed to at gate pushback. Call for Release flights are departures that require approval from Air Route Traffic Control Center prior to release. Realism is brought to the study by including gate departure delay and taxi-out delay uncertainties for the 77 major U. S. airports. Gate departure delay uncertainty is assumed to increase as a function of look-ahead time. Results show that Call For Release flights from an airport within the freeze horizon (a region surrounding the arrival airport) can get an advantage over other flights to a capacity constrained airport by scheduling prior to gate pushback, provided the wheels-off time uncertainty with respect to schedule is controlled to a small value, such as within a three-minute window. Another finding of the study is that system delay, measured as the sum of arrival delays, is smaller when flights are scheduled in the order of arrival compared to in the order of departure. Because flights from airports within the freeze horizon are scheduled in the order of departure, an increase in the number of internal airports with a larger freeze horizon increases system delay. Delay in the given scenario was found to increase by 126% (from 13.8 hours to 31.2 hours) as freeze horizon was increased from 30-minutes to 2-hours in the baseline scenario.

  11. [Acupuncture clinical trials published in high impact factor journals].

    Science.gov (United States)

    Hu, Min; Liu, Jian-Ping; Wu, Xiao-Ke

    2014-12-01

    Acupuncture clinical trials are designed to provide reliable evidence of clinical efficacy, and SCI papers is one of the high-quality clinical efficacy of acupuncture research. To analyze these papers published in high impact factor journals on acupuncture clinical trials, we can study clinical trials from design to implementation, the efficacy of prevention and cure, combined with international standard practices to evaluate the effectiveness and safety of acupuncture. That is the core of acupuncture clinical trials, as well as a prerequisite for outstanding academic output. A scientific and complete acupuncture clinical trial should be topically novel, designed innovative, logically clear, linguistically refining, and the most important point lies in a great discovery and solving the pragmatic problem. All of these are critical points of papers to be published in high impact factor journal, and directly affect international evaluation and promotion of acupuncture.

  12. Impact of headway distance and car speed on drivers' decisions to answer an incoming call.

    Science.gov (United States)

    Pouyakian, Mostafa; Mahabadi, Hassan Asilian; Yazdi, Seyedeh Monavar; Hajizadeh, Ebrahim; Nahvi, Ali

    2013-01-01

    Previous studies on factors affecting drivers' decisions to use their mobile phones while driving are mostly focused on psychological and sociocultural contexts. Few investigations have been carried out on the role of traffic circumstances on drivers' decisions to use or not to use a mobile phone. In this research, the effects of headway distance, speed, and the type of road as well as individual variables including age and driving experience are investigated. Forty-two subjects participated in observing 24 scenarios in a driving simulator. Logistic regression models showed that car speed, headway distance, and age can predict whether drivers' answer an incoming call while driving. The results indicated that traffic circumstances at the onset of phone calls are stronger predictors of drivers' decisions to answer a cell phone compared to driver-related variables. Headway distance and car speed can be used by in-vehicle information systems (IVIS) to warn drivers against using a mobile phone in certain traffic situations. Traffic safety campaigns for young drivers should focus on keeping safe headway distance and speed while driving.

  13. Disrupted seasonal biology impacts health, food security, and ecosystems: a call for integrated research

    NARCIS (Netherlands)

    Stevenson, T.J.; Visser, M.E.; Arnold, W.; Barrett, P.; Biello, S.; Dawson, A.; Denlinger, D.L.; Dominoni, Davide; Ebling, F.J.; Elton, S.; Evans, N.; Ferguson, H.M.; Foster, R.G.; Hau, M.; Haydon, D.T.; Hazlerigg, D.G.; Heideman, P.; Hopcraft, J.G.C.; Jonsson, N.N.; Kronfeld-Schor, N.; Kumar, V.; Lincoln, G.A.; MacLeod, R.; Martin, S.A.M.; Martinez-Bakker, M.; Nelson, R.J.; Reed, T.; Robinso, J.E.; Rock, D.; Schwartz, W.J.; Steffan-Dewenter, I.; Tauber, E.; Thackeray, S.J.; Umstatter, C.; Yoshimura, T.; Helm, B.

    2015-01-01

    The rhythm of life on earth is shaped by seasonal changes in the environment. Plants and animals show profound annual cycles in physiology, health, morphology, behaviour and demography in response to environmental cues. Seasonal biology impacts ecosystems and agriculture, with consequences for

  14. Impact of industry collaboration on randomised controlled trials in oncology.

    Science.gov (United States)

    Linker, Anne; Yang, Annie; Roper, Nitin; Whitaker, Evans; Korenstein, Deborah

    2017-02-01

    Industry funders can simply provide money or collaborate in trial design, analysis or reporting of clinical trials. Our aim was to assess the impact of industry collaboration on trial methodology and results of randomised controlled trials (RCT). We searched PubMed for oncology RCTs published May 2013 to December 2015 in peer-reviewed journals with impact factor > 5 requiring reporting of funder role. Two authors extracted methodologic (primary end-point; blinding of the patient, clinician and outcomes assessor; and analysis) and outcome data. We used descriptive statistics and two-sided Fisher exact tests to compare characteristics of trials with collaboration, with industry funding only, and without industry funding. We included 224 trials. Compared to those without industry funding, trials with collaboration used more placebo control (RR 3·59, 95% CI [1·88-6·83], p industry collaboration were more likely to use some high-quality methods than those without industry funding, with similar rates of positive results. Our findings suggest that collaboration is not associated with trial outcomes and that mandatory disclosure of funder roles may mitigate bias. Copyright © 2016 Elsevier Ltd. All rights reserved.

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

    Science.gov (United States)

    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).

  16. Prevalence and Impact of Work-Related Musculoskeletal Disorders on Job Performance of Call Center Operators in Nigeria

    Directory of Open Access Journals (Sweden)

    DO Odebiyi

    2016-04-01

    Full Text Available Background: Work-related musculoskeletal disorders (WMSDs have been documented among various occupational groups in Nigeria. However, there is limited data on the prevalence of WMSDs among call center operators (CCOs. Objective: To determine the prevalence of WMSDs among CCOs in Nigeria and to explore the extent to which these discomforts impact the daily work activities of the respondents. Methods: 374 respondents who were randomly selected from 4 telecommunication companies in Lagos State, Nigeria, participated in this study. They were asked to complete a pre-tested questionnaire designed to capture the prevalence, impact and associated risk factors of WMSDs among CCOs. Results: 42% and 65.2% of respondents experienced at least one WMSDs in the past 7 days, and 12 months, respectively. Women and CCOs who received calls with hand-held phones rather than headsets reported more discomforts during both 7 days and 12 months periods. Neck, shoulder, upper back, and lower back were the most affected areas during past 7 days and 12 months. Discomforts in the neck, low back, and knees prevented most of the respondents from performing their daily work. Conclusion: WMSDs have a serious impact on the daily job activities of the CCOs in Nigeria.

  17. Differences in delivery of respiratory treatments by on-call physiotherapists in mechanically ventilated children: a randomised crossover trial.

    Science.gov (United States)

    Shannon, Harriet; Stocks, Janet; Gregson, Rachael K; Hines, Sarah; Peters, Mark J; Main, Eleanor

    2015-12-01

    To investigate differences, if any, in the delivery of respiratory treatments to mechanically ventilated children between non-respiratory on-call physiotherapists and specialist respiratory physiotherapists. Paediatric, tertiary care hospital in the United Kingdom. 93 children (aged between 3 days and 16 years), and 22 physiotherapists (10 specialist respiratory physiotherapists) were recruited to the study. Recruited children received two physiotherapy treatments during a single day, one delivered by a non-respiratory physiotherapist, the other by a specialist respiratory physiotherapist in a randomised order. Selection, delivery and effects of techniques were recorded for each treatment. Primary outcomes were selection and application of treatment components. Secondary outcomes included respiratory effects (in terms of changes in flow, volume and pressure) of selected treatment components. Both non-respiratory on-call physiotherapists and specialist respiratory physiotherapists used combinations of saline instillation, manual lung inflations, chest wall vibrations and endotracheal suction during treatments. However specialist respiratory physiotherapists used combinations of chest wall vibrations with suction, and recruitment manoeuvres, significantly more frequently than non-respiratory on-call physiotherapists (92% vs 52%, and 87% vs 46% of treatments respectively, Prespiratory on-call physiotherapists were 15% less effective at increasing peak expiratory flow. Clinically important differences between non-respiratory and specialist respiratory physiotherapists' treatment outcomes may be related to differences in the selection and application of techniques. This suggests an important training need for non-respiratory on-call physiotherapists, particularly in the effective delivery of physiotherapy techniques. Clinicaltrials.gov NCT01999426. Copyright © 2015 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

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

    Science.gov (United States)

    Schneider, Nick K; Sebrié, Ernesto M; Fernández, Esteve

    2011-12-07

    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. Tobacco industry documents research triangulated against news and media reports. 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. 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.

  19. The journal impact factor as a predictor of trial quality and outcomes

    DEFF Research Database (Denmark)

    Gluud, Lise L; Sørensen, Thorkild I A; Gøtzsche, Peter C

    2005-01-01

    To examine the association between the impact factor and characteristics of hepatobiliary randomized clinical trials.......To examine the association between the impact factor and characteristics of hepatobiliary randomized clinical trials....

  20. Remote treatment of panic disorder: a randomized trial of internet-based cognitive behavior therapy supplemented with telephone calls.

    Science.gov (United States)

    Carlbring, Per; Bohman, Susanna; Brunt, Sara; Buhrman, Monica; Westling, Bengt E; Ekselius, Lisa; Andersson, Gerhard

    2006-12-01

    This study evaluated a 10-week Internet-based bibliotherapy self-help program with short weekly telephone calls for people suffering from panic disorder with or without agoraphobia. After the authors confirmed the diagnosis by administering the Structured Clinical Interview for DSM-IV by telephone, 60 participants were randomly assigned to either a wait-listed control group or a multimodal treatment package based on cognitive behavior therapy plus minimal therapist contact via e-mail. A 10-minute telephone call was made each week to support each participant. Total mean time spent on each participant during the 10 weeks was 3.9 hours. The participants were required to send in homework assignments before receiving the next treatment module. Analyses were conducted on an intention-to-treat basis, which included all randomly assigned participants. From pretreatment to posttreatment, all treated participants improved significantly on all measured dimensions (bodily interpretations, maladaptive cognitions, avoidance, general anxiety and depression levels, and quality of life). Treatment gains on self-report measures were maintained at the 9-month follow-up. A blind telephone interview after the end of treatment revealed that 77% of the treated patients no longer fulfilled the criteria for panic disorder, whereas all of the wait-listed subjects still suffered from it. This study provides evidence to support the use of treatment distributed via the Internet with the addition of short weekly telephone calls to treat panic disorder. Replication should be made to compare self-help and telephone treatment based on cognitive behavior methods with nonspecific interventions.

  1. 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 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.

  2. 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.

  3. 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.

  4. The influence of wearing schemes and supportive telephone calls on adherence in accelerometry measurement: results of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    van den Berg N

    2017-03-01

    Full Text Available Neeltje van den Berg,1,2 Sabina Ulbricht,2,3 Thea Schwaneberg,1,2 Kerstin Weitmann,1,2 Franziska Weymar,1–3 Stefan Groß,2,4 Marcus Dörr,2,4 Wolfgang Hoffmann1,2 1Institute for Community Medicine, University Medicine Greifswald, 2German Centre for Cardiovascular Research (DZHK, Partner Site Greifswald, 3Institute of Social Medicine and Prevention, University Medicine Greifswald, 4Department of Internal Medicine B, University Medicine Greifswald, Greifswald, Germany Background: Physical activity (PA can be assessed by accelerometer monitors. However, a high adherence to wearing this device is essential to obtain valid data. In this study, the influence of different wearing schemes and additional supportive phone calls (SPCs on adherence was examined. Methods: A randomized study with four groups was conducted in the context of a health examination program among participants aged 40–75 years without a history of cardiovascular diseases. Participants were recruited in different settings (general medical practices, job center, and health insurance. The participants were asked to wear an accelerometer for 7 consecutive days according to the wearing scheme “day and night” or “day only” and received or did not receive SPCs. Full adherence was defined as a total wearing time of 98 hours (between 8 am and 10 pm during 7 days. A generalized linear model was used to calculate the difference between the maximum possible and the observed adherence. Results: Adherence could be assessed for 249 participants (mean age: 56.40 years; standard deviation [SD] 9.83, 40% males. The mean wearing time was 84.04 hours (SD 20.75. Participants with the wearing scheme day and night were significantly more adherent than participants with the wearing scheme day only (incidence rate ratio [IRR] 0.63; P=0.005. SPCs had no additional effect on adherence (IRR 0.80; P=0.168. Conclusion: To assess PA, the wearing scheme day and night provides the best possible

  5. The effect of nurses’ preparedness and nurse practitioner status on triage call management in primary care: A secondary analysis of cross-sectional data from the ESTEEM trial

    Science.gov (United States)

    Varley, Anna; Warren, Fiona C.; Richards, Suzanne H.; Calitri, Raff; Chaplin, Katherine; Fletcher, Emily; Holt, Tim A.; Lattimer, Valerie; Murdoch, Jamie; Richards, David A.; Campbell, John

    2016-01-01

    Background Nurse-led telephone triage is increasingly used to manage demand for general practitioner consultations in UK general practice. Previous studies are equivocal about the relationship between clinical experience and the call outcomes of nurse triage. Most research is limited to investigating nurse telephone triage in out-of-hours settings. Objective To investigate whether the professional characteristics of primary care nurses undertaking computer decision supported software telephone triage are related to call disposition. Design Questionnaire survey of nurses delivering the nurse intervention arm of the ESTEEM trial, to capture role type (practice nurse or nurse practitioner), prescriber status, number of years’ nursing experience, graduate status, previous experience of triage, and perceived preparedness for triage. Our main outcome was the proportion of triaged patients recommended for follow-up within the practice (call disposition), including all contact types (face-to-face, telephone or home visit), by a general practitioner or nurse. Settings 15 general practices and 7012 patients receiving the nurse triage intervention in four regions of the UK. Participants 45 nurse practitioners and practice nurse trained in the use of clinical decision support software. Methods We investigated the associations between nursing characteristics and triage call disposition for patient ‘same-day’ appointment requests in general practice using multivariable logistic regression modelling. Results Valid responses from 35 nurses (78%) from 14 practices: 31/35 (89%) had ≥10 years’ experience with 24/35 (69%) having ≥20 years. Most patient contacts (3842/4605; 86%) were recommended for follow-up within the practice. Nurse practitioners were less likely to recommend patients for follow-up odds ratio 0.19, 95% confidence interval 0.07; 0.49 than practice nurses. Nurses who reported that their previous experience had prepared them less well for triage were more

  6. The effect of nurses' preparedness and nurse practitioner status on triage call management in primary care: A secondary analysis of cross-sectional data from the ESTEEM trial.

    Science.gov (United States)

    Varley, Anna; Warren, Fiona C; Richards, Suzanne H; Calitri, Raff; Chaplin, Katherine; Fletcher, Emily; Holt, Tim A; Lattimer, Valerie; Murdoch, Jamie; Richards, David A; Campbell, John

    2016-06-01

    Nurse-led telephone triage is increasingly used to manage demand for general practitioner consultations in UK general practice. Previous studies are equivocal about the relationship between clinical experience and the call outcomes of nurse triage. Most research is limited to investigating nurse telephone triage in out-of-hours settings. To investigate whether the professional characteristics of primary care nurses undertaking computer decision supported software telephone triage are related to call disposition. Questionnaire survey of nurses delivering the nurse intervention arm of the ESTEEM trial, to capture role type (practice nurse or nurse practitioner), prescriber status, number of years' nursing experience, graduate status, previous experience of triage, and perceived preparedness for triage. Our main outcome was the proportion of triaged patients recommended for follow-up within the practice (call disposition), including all contact types (face-to-face, telephone or home visit), by a general practitioner or nurse. 15 general practices and 7012 patients receiving the nurse triage intervention in four regions of the UK. 45 nurse practitioners and practice nurse trained in the use of clinical decision support software. We investigated the associations between nursing characteristics and triage call disposition for patient 'same-day' appointment requests in general practice using multivariable logistic regression modelling. Valid responses from 35 nurses (78%) from 14 practices: 31/35 (89%) had ≥10 years' experience with 24/35 (69%) having ≥20 years. Most patient contacts (3842/4605; 86%) were recommended for follow-up within the practice. Nurse practitioners were less likely to recommend patients for follow-up odds ratio 0.19, 95% confidence interval 0.07; 0.49 than practice nurses. Nurses who reported that their previous experience had prepared them less well for triage were more likely to recommend patients for follow-up (OR 3.17, 95% CI 1

  7. 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.

  8. Impact of protected sleep period for internal medicine interns on overnight call on depression, burnout, and empathy

    National Research Council Canada - National Science Library

    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

    .... 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...

  9. A Consult Is Just a Page Away: A Prospective Observational Study on the Impact of Jinxing on Call Karma in Neurosurgery.

    Science.gov (United States)

    Joswig, Holger; Zarnett, Lauren; Steven, David A; Stienen, Martin N

    2017-07-01

    Our aim was to assess the impact of jinxing on "call karma" in neurosurgery. We conducted a prospective observational study on 15 residents on call for the neurosurgery service, recording the total number of admissions, consults, deaths encountered, surgeries performed, hours of sleep and subjective call rating on a numeric rating scale (NRS) of 0-10 in terms of general awfulness. Some 204 on-call nightshifts were analyzed, of which 61 (29.9%) were jinxed and 143 (70.1%) were nonjinxed. Jinxes seemed to occur in clusters. The baseline parameters (experience, type of call coverage and superstition level) of the study groups were well balanced. A trend toward more surgeries was observed during jinxed nights, where residents slept significantly less (mean 147.8±96.2 vs. 180.9±106.1 min, p=0.037) and rated their on-call experience worse on the NRS (4.4±2.2 vs. 3.5±2.0, p=0.011), while there was no significant difference in number of admissions, consults or deaths. The act of jinxing ought to be avoided in the neurosurgical setting, as it might be potentially harmful to resident call karma, irrespective of level of experience, resources and personal beliefs.

  10. Call document

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

    Marie-Isabelle Beyer

    2014-10-03

    Oct 3, 2014 ... o empirical study of the impact of globalisation and market liberalisation on the barriers to entry for women – wage gaps, occupational segregation by gender, labour force participation, women entrepreneurship; o impacts of technological change for women's economic empowerment (big data,.

  11. EMERGENCY CALLS

    CERN Document Server

    2001-01-01

    IN URGENT NEED OF A DOCTOR GENEVA EMERGENCY SERVICES GENEVA AND VAUD 144 FIRE BRIGADE 118 POLICE 117 CERN FIREMEN 767-44-44 ANTI-POISONS CENTRE Open 24h/24h 01-251-51-51 Patient not fit to be moved, call family doctor, or: GP AT HOME, open 24h/24h 748-49-50 Association Of Geneva Doctors Emergency Doctors at home 07h-23h 322 20 20 Patient fit to be moved: HOPITAL CANTONAL CENTRAL 24 Micheli-du-Crest 372-33-11 ou 382-33-11 EMERGENCIES 382-33-11 ou 372-33-11 CHILDREN'S HOSPITAL 6 rue Willy-Donzé 372-33-11 MATERNITY 32 bvd.de la Cluse 382-68-16 ou 382-33-11 OPHTHALMOLOGY 22 Alcide Jentzer 382-33-11 ou 372-33-11 MEDICAL CENTRE CORNAVIN 1-3 rue du Jura 345 45 50 HOPITAL DE LA TOUR Meyrin EMERGENCIES 719-61-11 URGENCES PEDIATRIQUES 719-61-00 LA TOUR MEDICAL CENTRE 719-74-00 European Emergency Call 112 FRANCE EMERGENCY SERVICES 15 FIRE BRIGADE 18 POLICE 17 CERN FIREMEN AT HOME 00-41-22-767-44-44 ANTI-POISONS CENTRE Open 24h/24h 04-72-11-69-11 All doctors ...

  12. Oh what a beautiful morning! The time of day effect on the tone and market impact of conference calls

    NARCIS (Netherlands)

    Chen, J.; Demers, E.; Lev, B.

    2013-01-01

    Using textual analysis software, we examine whether and how the tone of the question and answer ("Q&A") portion of earnings-related conference calls varies with the time of day. We find that the tone of the conversations between analysts and managers becomes significantly more negative as the day

  13. 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

  14. A Call for a Community of Practice to Assess the Impact of Emerging Technologies on Undergraduate Biology Education

    Directory of Open Access Journals (Sweden)

    Jamie L. Jensen

    2012-02-01

    Full Text Available Recent recommendations for educational research encourage empirically tested, theory-based, completely transparent, and broadly applicable studies. In light of these recommendations, we call for a research standard and community of practice in the evaluation of technology use in the undergraduate life science classroom. We outline appropriate research methodology, review and critique the past research on technology usage and, lastly, suggest a new and improved focus for research on emerging technologies.

  15. A call for a community of practice to assess the impact of emerging technologies on undergraduate biology education.

    Science.gov (United States)

    Jensen, Jamie L; Dario-Becker, Juville; Hughes, Lee E; Amburn, D Sue Katz; Shaw, Joyce A

    2012-01-01

    Recent recommendations for educational research encourage empirically tested, theory-based, completely transparent, and broadly applicable studies. In light of these recommendations, we call for a research standard and community of practice in the evaluation of technology use in the undergraduate life science classroom. We outline appropriate research methodology, review and critique the past research on technology usage and, lastly, suggest a new and improved focus for research on emerging technologies.

  16. The impact of codeine re-scheduling on misuse: a retrospective review of calls to Australia's largest poisons centre.

    Science.gov (United States)

    Cairns, Rose; Brown, Jared A; Buckley, Nicholas A

    2016-10-01

    Codeine is the most commonly used opioid in the world, and is available over the counter (OTC) in many countries, including Australia. Several countries are reconsidering codeine's OTC status due to concerns over addiction and misuse, with serious morbidity and mortality being reported. Australia's Therapeutic Goods Administration restricted codeine containing analgesics to 'Pharmacist Only' in 2010, and has recently been considering further up-scheduling to make codeine 'Prescription Only'. This paper estimated Australian trends of codeine misuse over the past 12 years, and examined whether trends changed following previous rescheduling efforts in 2010. A retrospective review of calls regarding codeine misuse made to the New South Wales Poisons Information Centre (NSWPIC, Australia's largest poisons centre), 2004-15. Joinpoint software was used to quantify the average annual change in calls, and whether there was a significant change in trend at any time, including following rescheduling. Australia. Four hundred patients about whom a call was made to the NSWPIC. Calls per year, patient age, gender, tablets taken per day, formulation used, symptom disposition. The NSWPIC database contained 400 cases of codeine combination analgesic misuse from 2004 to 2015. Joinpoint analysis showed that the frequency of cases increased significantly from 2004 to 2015, with an average annual percentage change (AAPC) of 19.5% [95% confidence interval (CI) = 13.8-25.5% P codeine and 17.9% (95% CI = 7.9-28.9%, P codeine. No significant change in trend was seen at any time, including following 2010 rescheduling. The median age of patients was 34 and 27 years for paracetamol/codeine and ibuprofen/codeine cases, respectively. Gender distribution was approximately equal. Clinical features reported were consistent with codeine, paracetamol and ibuprofen toxicity. Misuse of codeine combination products appears to be increasing in Australia. Limited rescheduling in 2010

  17. 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.

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

    Science.gov (United States)

    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

    2016-09-01

    To illustrate how pragmatic trial design elements or inserting explanatory trial elements in pragmatic trials affect validity, generalizability, precision, and operational feasibility. From illustrative examples identified through the IMI Get Real Consortium, we selected randomized drug trials with a pragmatic design feature. We searched all publications on these trials for information on how pragmatic trial design features affect validity, generalizability, precision, or feasibility. We present examples from the Salford lung study, International Suicide Prevention Trial, Sequenced Treatment Alternatives to Relieve Depression, and Cluster Randomized Usual care vs. Caduet Investigation Assessing Long-term-risk trial. These examples show that incorporating pragmatic trial design elements in trials may affect generalizability, precision and validity and may lead to operational challenges different from traditional explanatory trials. Inserting explanatory trial elements into pragmatic trials may also affect validity, generalizability, and operational feasibility, especially when these trial elements are incorporated in one arm of the trial only. Design choices that positively affect one of these domains (e.g., generalizability) may negatively affect others (e.g., feasibility). Consequences of incorporating pragmatic or explanatory trial design elements in pragmatic trials should be explicitly considered and balanced for all relevant domains, including validity, generalizability, precision, and operational feasibility. Tools are needed to make these consequences more transparent. Copyright © 2016 Elsevier Inc. All rights reserved.

  19. The antiestrogens tamoxifen and fulvestrant abolish estrogenic impacts of 17α-ethinylestradiol on male calling behavior of Xenopus laevis.

    Directory of Open Access Journals (Sweden)

    Frauke Hoffmann

    Full Text Available Various synthetic chemicals released to the environment can interfere with the endocrine system of vertebrates. Many of these endocrine disrupting compounds (EDCs exhibit estrogenic activity and can interfere with sexual development and reproductive physiology. More recently, also chemicals with different modes of action (MOAs, such as antiestrogenic, androgenic and antiandrogenic EDCs, have been shown to be present in the environment. However, to date EDC-research primarily focuses on exposure to EDCs with just one MOA, while studies examining the effects of simultaneous exposure to EDCs with different MOAs are rare, although they would reflect more real, natural exposure situations. In the present study the combined effects of estrogenic and antiestrogenic EDCs were assessed by analyzing the calling behavior of short-term exposed male Xenopus laevis. The estrogenic 17α-ethinylestradiol (EE2, and the antiestrogenic EDCs tamoxifen (TAM and fulvestrant (ICI were used as model substances. As previously demonstrated, sole EE2 exposure (10-10 M resulted in significant alterations of the male calling behavior, including altered temporal and spectral parameters of the advertisement calls. Sole TAM (10-7 M, 10-8 M, 10-10 M or ICI (10-7 M exposure, on the other hand, did not affect any of the measured parameters. If frogs were co-exposed to EE2 (10-10 M and TAM (10-7 M the effects of EE2 on some parameters were abolished, but co-exposure to EE2 and ICI (10-7 M neutralized all estrogenic effects. Thus, although EDCs with antiestrogenic MOA might not exhibit any effects per se, they can alter the estrogenic effects of EE2. Our observations demonstrate that there is need to further investigate the combined effects of EDCs with various, not only opposing, MOAs as this would reflect realistic wildlife situations.

  20. The Antiestrogens Tamoxifen and Fulvestrant Abolish Estrogenic Impacts of 17α-ethinylestradiol on Male Calling Behavior of Xenopus laevis

    Science.gov (United States)

    Hoffmann, Frauke; Kloas, Werner

    2012-01-01

    Various synthetic chemicals released to the environment can interfere with the endocrine system of vertebrates. Many of these endocrine disrupting compounds (EDCs) exhibit estrogenic activity and can interfere with sexual development and reproductive physiology. More recently, also chemicals with different modes of action (MOAs), such as antiestrogenic, androgenic and antiandrogenic EDCs, have been shown to be present in the environment. However, to date EDC-research primarily focuses on exposure to EDCs with just one MOA, while studies examining the effects of simultaneous exposure to EDCs with different MOAs are rare, although they would reflect more real, natural exposure situations. In the present study the combined effects of estrogenic and antiestrogenic EDCs were assessed by analyzing the calling behavior of short-term exposed male Xenopus laevis. The estrogenic 17α-ethinylestradiol (EE2), and the antiestrogenic EDCs tamoxifen (TAM) and fulvestrant (ICI) were used as model substances. As previously demonstrated, sole EE2 exposure (10−10 M) resulted in significant alterations of the male calling behavior, including altered temporal and spectral parameters of the advertisement calls. Sole TAM (10−7 M, 10−8 M, 10−10 M) or ICI (10−7 M) exposure, on the other hand, did not affect any of the measured parameters. If frogs were co-exposed to EE2 (10−10 M) and TAM (10−7 M) the effects of EE2 on some parameters were abolished, but co-exposure to EE2 and ICI (10−7 M) neutralized all estrogenic effects. Thus, although EDCs with antiestrogenic MOA might not exhibit any effects per se, they can alter the estrogenic effects of EE2. Our observations demonstrate that there is need to further investigate the combined effects of EDCs with various, not only opposing, MOAs as this would reflect realistic wildlife situations. PMID:23028589

  1. 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.

  2. 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 health-related quality of life was noted in both groups. The use of a ceramide-infused barrier significantly decreased cost and

  3. Computer-Assisted Language Learning (CALL in the EFL Classroom and its Impact on Effective Teaching-learning Process in Saudi Arabia

    Directory of Open Access Journals (Sweden)

    Naiyer Azam Hashmi

    2016-03-01

    Full Text Available It is very interesting to see how Computer Assisted Language Learning (CALL has attracted many Arab students in learning English as a foreign language in the institutions of higher learning. It has great impact on their academic lives especially on teaching-learning process inside the classrooms. As a response to the students’ attraction in call, computer technologies have been brought into classrooms where they are considered to be effective in enhancing students learning and addressing certain education problems. The institutions of higher learning in Saudi Arabia, their students and faculty members have decided to try their best to utilize computer and other related technologies in their EFL classrooms for their fruitful teaching and learning outcomes. Thus, computers have taken centre stage and play an important role when it comes to language instruction in Saudi Arabia.

  4. Impact of the global burden of periodontal diseases on health, nutrition and wellbeing of mankind: A call for global action.

    Science.gov (United States)

    Tonetti, Maurizio S; Jepsen, Søren; Jin, Lijian; Otomo-Corgel, Joan

    2017-05-01

    The global burden of periodontal diseases remains high. Population growth trends, changes in risk factors and improved tooth retention will increase the socio-economic burden of periodontitis that is responsible for 3.5 million years lived with disability, 54 billion USD/year in lost productivity and a major portion of the 442 billion USD/year cost for oral diseases. In the context of the Milan World Exhibition 2015 "Feeding the Planet, Energy for Life," a green paper was developed and offered for global consultation by the European Federation of Periodontology. The final draft was endorsed by professional organizations around the world and is presented to stakeholders as a call for global action. Specific actions for the public, policymakers, educators and professional organizations have been identified in the areas of prevention, detection and care. These actions align public interest and knowledge, need for self-care, professional intervention and policies to the best scientific evidence to proactively promote periodontal health and effectively manage the global burden of periodontal diseases, in accordance with WHO/UN priorities and strategies for tackling common non-communicable diseases via the Common Risk Factor Approach. A strong and coherent body of evidence allows identification of actionable preventive, diagnostic and therapeutic strategies to effectively promote periodontal health and general wellbeing, and better manage the socio-economic consequences. Action requires consideration of the specific national scenarios. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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

    Directory of Open Access Journals (Sweden)

    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

  6. Can fatigue affect acquisition of new surgical skills? A prospective trial of pre- and post-call general surgery residents using the da Vinci surgical skills simulator.

    Science.gov (United States)

    Robison, Weston; Patel, Sonya K; Mehta, Akshat; Senkowski, Tristan; Allen, John; Shaw, Eric; Senkowski, Christopher K

    2017-08-24

    To study the effects of fatigue on general surgery residents' performance on the da Vinci Skills Simulator (dVSS). 15 General Surgery residents from various postgraduate training years (PGY2, PGY3, PGY4, and PGY5) performed 5 simulation tasks on the dVSS as recommended by the Robotic Training Network (RTN). The General Surgery residents had no prior experience with the dVSS. Participants were assigned to either the Pre-call group or Post-call group based on call schedule. As a measure of subjective fatigue, residents were given the Epworth Sleepiness Scale (ESS) prior to their dVSS testing. The dVSS MScore™ software recorded various metrics (Objective Structured Assessment of Technical Skills, OSATS) that were used to evaluate the performance of each resident to compare the robotic simulation proficiency between the Pre-call and Post-call groups. Six general surgery residents were stratified into the Pre-call group and nine into the Post-call group. These residents were also stratified into Fatigued (10) or Nonfatigued (5) groups, as determined by their reported ESS scores. A statistically significant difference was found between the Pre-call and Post-call reported sleep hours (p = 0.036). There was no statistically significant difference between the Pre-call and Post-call groups or between the Fatigued and Nonfatigued groups in time to complete exercise, number of attempts, and high MScore™ score. Despite variation in fatigue levels, there was no effect on the acquisition of robotic simulator skills.

  7. A Call for Further Research on the Impact of State-Level Immigration Policies on Public Health

    Science.gov (United States)

    Getrich, Christina M.; Quezada, Julio C.; Guay, Amanda; Michalowski, Raymond J.; Henley, Eric

    2012-01-01

    Arizona’s Support Our Law Enforcement and Safe Neighborhoods Act, signed into law in April 2010, is already adversely affecting public health in the state. Our findings from a study on childhood obesity in Flagstaff suggest that the law changed health-seeking behaviors of residents of a predominantly Latino neighborhood by increasing fear, limiting residents’ mobility, and diminishing trust of officials. These changes could exacerbate barriers to healthy living, limit access to care, and affect the overall safety of the neighborhood. Documentation of the on-the-ground impact of Arizona's law and similar state-level immigration policies is urgently needed. To inform effective policymaking, such research must be community engaged and include safety measures beyond the usual protocols. PMID:22594736

  8. 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.

  9. Organic fertilisers of the MAC trial and their impact on soil quality, environment and climate change.

    OpenAIRE

    Koopmans, C.J.; Zanen, M.; Bokhorst, G.J.

    2008-01-01

    After 8 years, the MAC field trial in Lelystad, the Netherlands, shows the effects of different fertiliser strategies, ranging from animal manure to plant compost to mineral fertiliser. The impact on yield, soil quality, soil health, environment and climate change is discussed. The trial is unique in monitoring th eeffect of so many types of fertilisers over so many years.

  10. The impact of data errors on the outcome of randomized clinical trials

    NARCIS (Netherlands)

    Buyse, Marc; Squifflet, Pierre; Coart, Elisabeth; Quinaux, Emmanuel; Punt, Cornelis J. A.; Saad, Everardo D.

    2017-01-01

    Background/aims: Considerable human and financial resources are typically spent to ensure that data collected for clinical trials are free from errors. We investigated the impact of random and systematic errors on the outcome of randomized clinical trials. Methods: We used individual patient data

  11. Sparrowhawk movement, calling, and presence of dead conspecifics differentially impact blue tit (Cyanistes caeruleus) vocal and behavioral mobbing responses.

    Science.gov (United States)

    Carlson, Nora V; Pargeter, Helen M; Templeton, Christopher N

    2017-01-01

    Many animals alter their anti-predator behavior in accordance to the threat level of a predator. While much research has examined variation in mobbing responses to different predators, few studies have investigated how anti-predator behavior is affected by changes in a predator's own state or behavior. We examined the effect of sparrowhawk ( Accipiter nisus ) behavior on the mobbing response of wild blue tits ( Cyanistes caeruleus ) using robotic taxidermy sparrowhawks. We manipulated whether the simulated predator moved its head, produced vocalizations, or held a taxidermy blue tit in its talons. When any sparrowhawk model was present, blue tits decreased foraging and increased anti-predator behavior and vocalizations. Additionally, each manipulation of the model predator's state (moving, vocalizing, or the presence of a dead conspecific) impacted different types of blue tit anti-predator behavior and vocalizations. These results indicate that different components of mobbing vary according to the specific state of a given predator-beyond its presence or absence-and suggest that each might play a different role in the overall mobbing response. Last, our results indicate that using more life-like predator stimuli-those featuring simple head movements and audio playback of vocalizations-changes how prey respond to the predator; these 'robo-raptor' models provide a powerful tool to provide increased realism in simulated predator encounters without sacrificing experimental control. Anti-predatory behavior is often modulated by the threat level posed by a particular predator. While much research has tested how different types of predators change prey behavior, few experiments have examined how predator behavior affects anti-predatory responses of prey. By experimentally manipulating robotic predators, we show that blue tits not only respond to the presence of a sparrowhawk, by decreasing feeding and increasing anti-predator behavior and vocalizations, but that they vary

  12. Impact of a subsidized spay neuter clinic on impoundments and euthanasia in a community shelter and on service and complaint calls to animal control.

    Science.gov (United States)

    Scarlett, Janet; Johnston, Naomi

    2012-01-01

    Reducing the number of homeless, nonhuman animals entering and being euthanatized in community shelters is the principal motivation for most spay/neuter (S/N) programs in the United States. This study evaluated the impact of a subsidized S/N clinic opened in 2005 in Transylvania County, North Carolina, on the numbers of impoundments (and euthanasia) of dogs and cats and on the number of animal-related service and complaint calls at the community's only animal shelter. Before opening the local S/N clinic, a significant linear decline in the shelter's dog-intake rate per 1,000 human population was evident. This decline did not accelerate after the S/N clinic opened in 2005. The rate of decline in euthanasia did level off after the clinic opened, but the proportion of impounded dogs euthanatized did not change significantly. The median number of cats impounded and euthanatized yearly in the Transylvania County Animal Services shelter decreased significantly after the S/N clinic opened; the proportion of cats euthanatized did not change. The median annual number of service calls and complaints decreased or leveled off. Unfortunately, data regarding many factors essential for conclusively interpreting these results were not available.

  13. Understanding the RECORDS 3 Trial and its impact on ...

    African Journals Online (AJOL)

    Venous thromboembolism is a significant cause of mortality and morbidity in patients following major orthopaedic surgeries. The RECORDS 3 trial revolutionised anticoagulation practice especially in patients with total knee arthroplasty and challenging the strong hold of warfarin and heparin in anticoagulation practice.

  14. Understanding the RECORDS 3 Trial and its impact on ...

    African Journals Online (AJOL)

    2015-12-06

    Dec 6, 2015 ... Venous thromboembolism is a significant cause of mortality and morbidity in patients following major orthopaedic surgeries. The RECORDS 3 trial revolutionised anticoagulation practice especially in patients with total knee arthroplasty and challenging the strong hold of warfarin and heparin in ...

  15. Call Forecasting for Inbound Call Center

    Directory of Open Access Journals (Sweden)

    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.

  16. The impact of registration of clinical trials units: the UK experience.

    Science.gov (United States)

    McFadden, Eleanor; Bashir, Saeeda; Canham, Steve; Darbyshire, Janet; Davidson, Peter; Day, Simon; Emery, Sean; Pater, Joseph; Rudkin, Sarah; Stead, Maxine; Brown, Julia

    2015-04-01

    Over the last decade, the United Kingdom has invested significant resources in its clinical trial infrastructure. Clinical research networks have been formed, and some general oversight functions for clinical research have been centralised. One of the initiatives is a registration programme for Clinical Trials Units involved in the coordination of clinical trials. An international review panel of experts in clinical trials has been convened for three reviews over time, reviewing applications from Clinical Trials Units in the United Kingdom. The process benefited from earlier work by the National Cancer Research Institute that developed accreditation procedures for trials units involved in cancer trials. This article describes the experience with the three reviews of UK Clinical Trials Units which submitted applications. This article describes the evolution and impact of this registration process from the perspective of the current international review panel members, some of whom have served on all reviews, including two done by the National Cancer Research Institute. Applications for registration were invited from all active, non-commercial Clinical Trials Units in the United Kingdom. The invitations were issued in 2007, 2009 and 2012, and applicants were asked to describe their expertise and staffing levels in specific areas. To ensure that the reviews were as objective as possible, a description of expected core competencies was developed and applicants were asked to document their compliance with meeting these. The review panel assessed each Clinical Trials Unit against the competencies. The Clinical Trials Unit registration process has evolved over time with each successive review benefiting from what was learned in earlier ones. The review panel has seen positive changes over time, including an increase in the number of units applying, a greater awareness on the part of host institutions about the trials activity within their organisations, more widespread

  17. Impact of including Korean randomized controlled trials in Cochrane reviews of acupuncture.

    Directory of Open Access Journals (Sweden)

    Kun Hyung Kim

    Full Text Available OBJECTIVE: Acupuncture is commonly practiced in Korea and is regularly evaluated in clinical trials. Although many Cochrane reviews of acupuncture include searches of both English and Chinese databases, there is no information on the value of searching Korean databases. This study aimed to investigate the impact of searching Korean databases and journals for trials eligible for inclusion in existing Cochrane acupuncture reviews. METHODS: We searched 12 Korean databases and seven Korean journals to identify randomised trials meeting the inclusion criteria for acupuncture reviews in the Cochrane Database of Systematic Reviews. We compared risk of bias assessments of the Korean trials with the trials included in the Cochrane acupuncture reviews. Where possible, we added data from the Korean trials to the existing meta-analyses in the relevant Cochrane review and conducted sensitivity analyses to test the robustness of the results. RESULTS: Sixteen Korean trials (742 participants met the inclusion criteria for eight Cochrane acupuncture reviews (125 trials; 13,041 participants. Inclusion of the Korean trials provided data for 20% of existing meta-analyses (24 out of 120. Inclusion of the Korean trials did not change the direction of effect in any of the existing meta-analyses. The effect size and heterogeneity remained mostly unchanged. In only one meta-analysis did the significance change. Compared to the studies included in the Cochrane acupuncture reviews, the risk of bias in the Korean trials was higher in terms of outcome assessor blinding and allocation concealment. CONCLUSIONS: Many Korean studies contributed additional data to the existing meta-analyses in Cochrane acupuncture reviews. Although inclusion of these studies did not alter the results of the meta-analyses, comprehensive searches of the literature are important to avoid potential language bias. The identification and inclusion of eligible Korean trials should be considered for

  18. The impact of behavioural screening on intervention outcomes in a randomised, controlled multiple behaviour intervention trial

    Directory of Open Access Journals (Sweden)

    Fjeldsoe Brianna S

    2011-03-01

    Full Text Available Abstract Background With an increasing research focus on multiple health behaviour change interventions, a methodological issue requiring further investigation is whether or not to employ pre-trial behavioural screening to exclude participants who are achieving a pre-specified level of one or more behaviours. Behavioural screening can be used to direct limited resources to participants most in need of a behaviour change intervention; but may reduce the representativeness of the sample and limit comparability with trials that do not employ pre-trial behavioural screening. Furthermore, the impact of this type of screening on intervention participation and intervention effects is unknown. Methods Data for this study come from the Logan Healthy Living Program, a randomised, controlled telephone counselling lifestyle intervention trial which did not employ behavioural screening prior to randomisation. Screening for physical activity, diet or the combination was simulated using baseline trial data. To examine the impact of behavioural screening on intervention participation (in terms of participant characteristics, intervention dose received and retention, characteristics of participants included an excluded under the various screening scenarios were compared. To examine the impact of behavioural screening on intervention effects, results from the main trial analysis were compared with results obtained from the same analyses performed separately for each of the screened groups. Results Simulated pre-trial behavioural screening impacted minimally on intervention dose received and trial retention rate. Beyond the anticipated effect of reducing baseline levels of the behaviours being screened for, behavioural screening affected baseline levels of behaviours not targeted by screening, and participants' demographic and health-related characteristics. Behavioural screening impacted on intervention effects in ways that were anticipated and positive, but also

  19. Database trial impact on graduate nursing comprehensive exams.

    Science.gov (United States)

    Pionke, Katharine; Huckstadt, Alicia

    2015-10-01

    While the authors were doing a test period of databases, the question of whether or not databases affect outcomes of graduate nursing comprehensive examinations came up. This study explored that question through using citation analysis of exams that were taken during a database trial and exams that were not. The findings showed no difference in examination pass/fail rates. While the pass/fail rates did not change, a great deal was learned in terms of citation accuracy and types of materials that students used, leading to discussions about changing how citation and plagiarism awareness were taught.

  20. Trial Protocol: Communicating DNA-based risk assessments for Crohn's disease: a randomised controlled trial assessing impact upon stopping smoking

    Directory of Open Access Journals (Sweden)

    Armstrong David

    2011-01-01

    Full Text Available Abstract Background Estimates of the risk of developing Crohn's disease (CD can be made using DNA testing for mutations in the NOD2 (CARD15 gene, family history, and smoking status. Smoking doubles the risk of CD, a risk that is reduced by stopping. CD therefore serves as a timely and novel paradigm within which to assess the utility of predictive genetic testing to motivate behaviour change to reduce the risk of disease. The aim of the study is to describe the impact upon stopping smoking of communicating a risk of developing CD that incorporates DNA analysis. We will test the following main hypothesis: Smokers who are first degree relatives (FDRs of CD probands are more likely to make smoking cessation attempts following communication of risk estimates of developing CD that incorporate DNA analysis, compared with an equivalent communication that does not incorporate DNA analysis. Methods/design A parallel groups randomised controlled trial in which smokers who are FDRs of probands with CD are randomly allocated in families to undergo one of two types of assessment of risk for developing CD based on either: i. DNA analysis, family history of CD and smoking status, or ii. Family history of CD and smoking status The primary outcome is stopping smoking for 24 hours or longer in the six months following provision of risk information. The secondary outcomes are seven-day smoking abstinence at one week and six month follow-ups. Randomisation of 470 smoking FDRs of CD probands, with 400 followed up (85%, provides 80% power to detect a difference in the primary outcome of 14% between randomised arms, at the 5% significance level. Discussion This trial provides one of the strongest tests to date of the impact of communicating DNA-based risk assessment on risk-reducing behaviour change. Specific issues regarding the choice of trial design are discussed. Trial Registration ISRCTN: ISRCTN21633644

  1. 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)

    Mendes, Romeu; Moreira, Amélia; Lunet, Nuno

    2017-01-01

    Introduction 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. Methods 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. Ethics and dissemination The study was

  2. Quality of life and functional capacity outcomes in the MOMENTUM 3 trial at 6 months: A call for new metrics for left ventricular assist device patients.

    Science.gov (United States)

    Cowger, Jennifer A; Naka, Yoshifumi; Aaronson, Keith D; Horstmanshof, Douglas; Gulati, Sanjeev; Rinde-Hoffman, Debbie; Pinney, Sean; Adatya, Sirtaz; Farrar, David J; Jorde, Ulrich P

    2018-01-01

    The Multicenter Study of MAGLEV Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3 (MOMENTUM 3) clinical trial demonstrated improved 6-month event-free survival, but a detailed analysis of health-related quality of life (HR-QOL) and functional capacity (FC) was not presented. Further, the effect of early serious adverse events (SAEs) on these metrics and on the general ability to live well while supported with a left ventricular assist system (LVAS) warrants evaluation. FC (New York Heart Association [NYHA] and 6-minute walk test [6MWT]) and HR-QOL (European Quality of Life [EQ-5D-5L] and the Kansas City Cardiomyopathy [KCCQ]) assessments were obtained at baseline and 6 months after HeartMate 3 (HM3, n = 151; Abbott, Abbott Park, IL) or HeartMate II (HMII, n = 138; Abbott) implant as part of the MOMENTUM 3 clinical trial. Metrics were compared between devices and in those with and without events. The proportion of patients "living well on an LVAS" at 6 months, defined as alive with satisfactory FC (NYHA I/II or 6MWT > 300 meters) and HR-QOL (overall KCCQ > 50), was evaluated. Although the median (25th-75th percentile) patient KCCQ (change for HM3: +28 [10-46]; HMII: +29 [9-48]) and EQ-5D-5L (change for HM3: -1 [-5 to 0]; HMII: -2 [-6 to 0]) scores improved from baseline to 6 months (p 0.05). Likewise, there was an equivalent improvement in 6MWT distance at 6 months in HM3 (+94 [1-274] meters] and HMII (+188[43-340 meters]) from baseline. In patients with SAEs (n = 188), 6MWTs increased from baseline (p metrics did not change. The development of left ventricular assist device-specific HR-QOL tools is needed to better characterize the effect of SAEs on a patient's well-being. MOMENTUM 3 clinical trial #NCT02224755. Copyright © 2018 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

  3. 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…

  4. 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...

  5. Impact of baseline BMI and weight change in CCTG adjuvant breast cancer trials.

    Science.gov (United States)

    Yerushalmi, R; Dong, B; Chapman, J W; Goss, P E; Pollak, M N; Burnell, M J; Levine, M N; Bramwell, V H C; Pritchard, K I; Whelan, T J; Ingle, J N; Shepherd, L E; Parulekar, W R; Han, L; Ding, K; Gelmon, K A

    2017-07-01

    We hypothesized that increased baseline BMI and BMI change would negatively impact clinical outcomes with adjuvant breast cancer systemic therapy. Data from chemotherapy trials MA.5 and MA.21; endocrine therapy MA.12, MA.14 and MA.27; and trastuzumab HERA/MA.24 were analyzed. The primary objective was to examine the effect of BMI change on breast cancer-free interval (BCFI) landmarked at 5 years; secondary objectives included BMI changes at 1 and 3 years; BMI changes on disease-specific survival (DSS) and overall survival (OS); and effects of baseline BMI. Stratified analyses included trial therapy and composite trial stratification factors. In pre-/peri-/early post-menopausal chemotherapy trials (N = 2793), baseline BMI did not impact any endpoint and increased BMI from baseline did not significantly affect BCFI (P = 0.85) after 5 years although it was associated with worse BCFI (P = 0.03) and DSS (P = 0.07) after 1 year. BMI increase by 3 and 5 years was associated with better DSS (P = 0.01; 0.01) and OS (P = 0.003; 0.05). In pre-menopausal endocrine therapy trial MA.12 (N = 672), patients with higher baseline BMI had worse BCFI (P = 0.02) after 1 year, worse DSS (P = 0.05; 0.004) after 1 and 5 years and worse OS (P = 0.01) after 5 years. Increased BMI did not impact BCFI (P = 0.90) after 5 years, although it was associated with worse BCFI (P = 0.01) after 1 year. In post-menopausal endocrine therapy trials MA.14 and MA.27 (N = 8236), baseline BMI did not significantly impact outcome for any endpoint. BMI change did not impact BCFI or DSS after 1 or 3 years, although a mean increased BMI of 0.3 was associated with better OS (P = 0.02) after 1 year. With the administration of trastuzumab (N = 1395) baseline BMI and BMI change did not significantly impact outcomes. Higher baseline BMI and BMI increases negatively affected outcomes only in pre-/peri-/early post-menopausal trial patients. Otherwise, BMI

  6. Effect of an art brut therapy program called go beyond the schizophrenia (GBTS) on prison inmates with schizophrenia in mainland China-A randomized, longitudinal, and controlled trial.

    Science.gov (United States)

    Qiu, Hong-Zhong; Ye, Zeng-Jie; Liang, Mu-Zi; Huang, Yue-Qun; Liu, Wei; Lu, Zhi-Dong

    2017-09-01

    Creative arts therapies are proven to promote an interconnection between body and mind, but there are major obstacles for providing therapeutic services in prisons due to inmates' inherent mistrust for verbal disclosure and rigid self-defenses, especially among inmates with schizophrenia. Thus, we developed a structured and quantitative art brut therapy program called go beyond the schizophrenia to actually measure the benefits of art therapy on prison inmates in mainland China. Upon completion of the program, the intervention group reported a decrease in anxiety, depression, anger, and negative psychiatric symptoms and showed better compliance with rules, socialization with peers, compliance with medications, and regular sleeping patterns after 16 weekly sessions of go beyond the schizophrenia. This article concludes that the art brut therapy was effective for the inmates with schizophrenia in mainland China and provides encouraging data on how to enhance mental health for inmates with schizophrenia. Art brut therapy can reduce emotional distress and negative psychiatric symptoms among Chinese inmates. Arts brut therapy can enhance Chinese inmates' compliance with rules, socialization with peers, compliance with medicines, and regular sleeping patterns. Arts brut therapy in conjunction with medication is highly recommended for recovery of Chinese inmates with schizophrenia, especially for patients with negative symptoms. Copyright © 2017 John Wiley & Sons, Ltd.

  7. CALL FOR PARTICIPATION

    Directory of Open Access Journals (Sweden)

    Alejandro Jimenez M.

    2008-10-01

    Full Text Available TRIPLE HELIX VII 7TH BIENNIAL INTERNATIONAL CONFERENCE ON UNIVERSITY, INDUSTRY AND GOVERNMENT LINKAGES “THE ROLE OF TRIPLE HELIX IN THE GLOBAL AGENDA FOR INNOVATION, COMPETITIVENESS AND SUSTAINABILITY” UNIVERSITY OF STRATHCLYDE, GLASGOW, SCOTLAND 17-19 JUNE 2009 CALL FOR PARTICIPATION CLOSING DATE FOR ABSTRACT SUBMISSION – 14 NOVEMBER 2008 Triple Helix VII is an important occasion offering a major platform for the exchange of ideas and experiences - academics will share their insights into the dynamics of collaboration; business and industry will review their plans and indicate future directions; and for government decision makers, will explore new avenues for supporting developments, analysing innovation frameworks and their impact on national and regional economies. A Call for Papers is attached, and further details can be obtained from the Triple Helix VII website: http://www.triple-helix-7.org. We hope the Conference will be of interest to you and look forward to seeing you in Glasgow next year taking part in the Triple Helix VII proceedings. Sheila Forbes Conference Administrator Triple Helix VII

  8. Impact of Killing in War: A Randomized, Controlled Pilot Trial.

    Science.gov (United States)

    Maguen, Shira; Burkman, Kristine; Madden, Erin; Dinh, Julie; Bosch, Jeane; Keyser, Jessica; Schmitz, Martha; Neylan, Thomas C

    2017-09-01

    The purpose of this pilot study was to test the effectiveness of Impact of Killing (IOK), a novel, cognitive-behavioral treatment (CBT) aimed at reducing mental health symptoms and functional impairment. Participants were 33 combat Veterans with a posttraumatic stress disorder (PTSD) diagnosis who had completed trauma-focused psychotherapy and reported distress regarding killing or feeling responsible for the deaths of others in war. Veterans were randomized to either IOK treatment or a 6-week waitlist condition, after which Veterans could receive IOK. IOK is a 6- to 8-session, weekly, individual, CBT, lasting 60-90 minutes, and focused on key themes, including physiology of killing responses, moral injury, self-forgiveness, spirituality, making amends, and improved functioning. We found that compared to controls (N = 16), the IOK group (N = 17) experienced a significant improvement in PTSD symptoms, general psychiatric symptoms, and quality of life functional measures. Veterans who received IOK reported that the treatment was acceptable and feasible. These results provide preliminary evidence that Veterans can benefit from a treatment focused on the impact of killing after initial trauma therapy. © 2017 Wiley Periodicals, Inc.

  9. Impact of the JUPITER trial on statin prescribing for primary prevention.

    Science.gov (United States)

    Teng, Jennifer F T; Gomes, Tara; Camacho, Ximena; Grundy, Scott; Juurlink, David N; Mamdani, Muhammad M

    2014-01-01

    As the Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) trial identified a new population of individuals with cholesterol levels below traditional treatment thresholds but with elevated high-sensitivity C-reactive protein (hs-CRP) levels who may benefit from primary prevention with statin therapy, we sought to evaluate the impact of this trial on the incident prescription rates of rosuvastatin alone as well as all statins in a primary prevention population. Population-based, cross-sectional time-series analysis. Administrative health care databases in Ontario, Canada. A total of 299,809 incident statin users 66 years or older were identified during the study period, from January 1, 2003, to March 31, 2011, who were prescribed statin therapy for primary prevention. We evaluated the incident rate of rosuvastatin and all statin use during each quarter of the study period. Overall, no significant trends in all incident statin use were observed (p=0.99). Furthermore, no significant differences were observed in incident rates of rosuvastatin (p=0.21) or all statin (p=0.41) use after the publication of the JUPITER trial. Despite the lack of impact of the JUPITER trial on rosuvastatin or all statin utilization, the relative market share of rosuvastatin increased from 9% to 65% over the study period. The publication of the JUPITER trial did not significantly affect trends in overall statin and rosuvastatin prescribing patterns for primary prevention in this study. Increases in the relative market share of rosuvastatin may be attributed to the impact of the pharmaceutical industry on prescribing patterns. Our results highlight the need to further improve the integration of evidence-based prescribing into cost-effective clinical practice. © 2013 Pharmacotherapy Publications, Inc.

  10. 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

  11. IMPACT Observatory: tracking the evolution of clinical trial data sharing and research integrity.

    Science.gov (United States)

    Krleža-Jerić, Karmela; Gabelica, Mirko; Banzi, Rita; Martinić, Marina Krnić; Pulido, Bibiana; Mahmić-Kaknjo, Mersiha; Reveiz, Ludovic; Šimić, Josip; Utrobičić, Ana; Hrgović, Irena

    2016-10-15

    The opening of research data is emerging thanks to the increasing possibilities of digital technology. The opening of clinical trial (CT) data is a part of this process, expected to have positive scientific, ethical, health, and economic impacts thus contributing to research integrity. The January 2016 proposal by the International Council of Medical Journal Editors triggered ample discussion about CT data sharing and reconfirmed the need for an ongoing assessment of its dynamics. The IMProving Access to Clinical Trials data (IMPACT) Observatory aims to play such a role, and assess the data sharing culture, policies, and practices of key players, the impact of their interventions on CTs, and contribute to a transformation of research. The objective of this paper is to present the IMPACT Observatory as well as share some of its preliminary findings. Methods include a scoping study of research, surveys, interviews, and an environmental scan of research data repositories. Our preliminary findings indicate that although opening of CT data has not yet been achieved, its evolution is encouraging. Initiatives by key players contribute to increasing of CT data sharing, and many barriers are shrinking or disappearing. The major barrier is the lack of data sharing standards, from preparing data for public sharing to its curatorship, findability and access. However, experiences accumulated by sharing CT data according to "upon request" or "open" mechanisms could inform the development of such standards. The Vivli, CORBEL-ECRIN and Open Trials projects are currently working in this direction.

  12. Effect of Text Message, Phone Call, and In-Person Appointment Reminders on Uptake of Repeat HIV Testing among Outpatients Screened for Acute HIV Infection in Kenya: A Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Peter M Mugo

    Full Text Available Following HIV-1 acquisition, many individuals develop an acute retroviral syndrome and a majority seek care. Available antibody testing cannot detect an acute HIV infection, but repeat testing after 2-4 weeks may detect seroconversion. We assessed the effect of appointment reminders on attendance for repeat HIV testing.We enrolled, in a randomized controlled trial, 18-29 year old patients evaluated for acute HIV infection at five sites in Coastal Kenya (ClinicalTrials.gov NCT01876199. Participants were allocated 1:1 to either standard appointment (a dated appointment card or enhanced appointment (a dated appointment card plus SMS and phone call reminders, or in-person reminders for participants without a phone. The primary outcome was visit attendance, i.e., the proportion of participants attending the repeat test visit. Factors associated with attendance were examined by bivariable and multivariable logistic regression.Between April and July 2013, 410 participants were randomized. Attendance was 41% (85/207 for the standard group and 59% (117/199 for the enhanced group, for a relative risk of 1.4 [95% Confidence Interval, CI, 1.2-1.7].Higher attendance was independently associated with older age, study site, and report of transactional sex in past month. Lower attendance was associated with reporting multiple partners in the past two months.Appointment reminders through SMS, phone calls and in-person reminders increased the uptake of repeat HIV test by forty percent. This low-cost intervention could facilitate detection of acute HIV infections and uptake of recommended repeat testing.Clinicaltrials.gov NCT01876199.

  13. Randomized Controlled Trial of an Intervention to Maintain Suppression of HIV Viremia After Prison Release: The imPACT Trial.

    Science.gov (United States)

    Wohl, David A; Golin, Carol E; Knight, Kevin; Gould, Michele; Carda-Auten, Jessica; Groves, Jennifer S; Napravnik, Sonia; Cole, Stephen R; White, Becky L; Fogel, Cathie; Rosen, David L; Mugavaro, Michael J; Pence, Brian W; Flynn, Patrick M

    2017-05-01

    HIV-infected individuals transitioning from incarceration to the community are at risk for loss of viral suppression. We compared the effects of imPACT, a multidimensional intervention to promote care engagement after release, to standard care on sustaining viral suppression after community re-entry. This trial randomized 405 HIV-infected inmates being released from prisons in Texas and North Carolina with HIV-1 RNA levels HIV-1 RNA HIV-1 RNA 0.99). Higher rates of HIV suppression and medical care engagement than expected based on previous literature were observed among HIV-infected patients with suppressed viremia released from prison. Randomization to a comprehensive intervention to motivate and facilitate HIV care access after prison release did not prevent loss of viral suppression. A better understanding of the factors influencing prison releasees' linkage to community care, medication adherence, and maintenance of viral suppression is needed to inform policy and other strategic approaches to HIV prevention and treatment.

  14. Exploiting dietary supplementation trials to assess the impact of the prenatal environment on CVD risk.

    OpenAIRE

    Hawkesworth, S.

    2008-01-01

    Animal studies have demonstrated that altering the maternal diet during pregnancy affects offspring disease risk. Data from human subjects on the early-life determinants of disease have been derived primarily from birth-weight associations; studies of the impact of the maternal diet are scarce and inconsistent. Investigating CVD risk factors in the offspring of women who have participated in maternal supplementation trials provides a useful resource in this research field, by virtue of employ...

  15. 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.

  16. 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.

  17. Validity of early MRI structural damage end points and potential impact on clinical trial design in rheumatoid arthritis

    DEFF Research Database (Denmark)

    Baker, Joshua F; Conaghan, Philip G; Emery, Paul

    2016-01-01

    OBJECTIVE: To evaluate the construct validity of the rheumatoid arthritis MRI score (RAMRIS) erosion evaluation as structural damage end point and to assess the potential impact of incorporation in clinical trials. METHODS: In a randomised trial of early methotrexate-naïve RA (GO-BEFORE), RAMRIS ...

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

    Science.gov (United States)

    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.

  19. Media portrayal of herbal remedies versus pharmaceutical clinical trials: impacts on decision.

    Science.gov (United States)

    Bubela, T; Koper, M; Boon, H; Caulfield, T

    2007-06-01

    The use of Complementary and Alternative Medicines (CAM) in Europe and North America is increasing significantly with a concomitant growth in business interest. Users are educated and self-empowered and rely on information sources beyond mainstream medical practitioners. Not surprisingly, media coverage, much of dubious quality, has increased to meet demand for information. Here we present data from a study that explores how knowledge is translated in the socioeconomic-political context of CAM as compared to conventional pharmaceuticals. Specifically, we are interested in the nature of the information provided by clinical trials and the media and how this might impact decision-making regarding the use of CAM versus conventional pharmaceuticals and the reporting of conflicts of interest and industry funding of research. Our results suggest that, in the media, there were significant errors of omission in describing clinical trial quality and a serious under-reporting of risks of herbal remedies. Consumers, who often self-administer CAM are not being provided with information sufficient to make informed choices about treatment alternatives. The next step in the research is to determine whether these reporting dynamics in describing CAM clinical trials differ from those of reporting on pharmaceutical clinical trials.

  20. Perceived information gain from randomized trials correlates with publication in high-impact factor journals.

    Science.gov (United States)

    Evangelou, Evangelos; Siontis, Konstantinos C; Pfeiffer, Thomas; Ioannidis, John P A

    2012-12-01

    To examine whether perceived information gain (IG) drives the publication of randomized trials in high-impact factor (IF) journals. We estimated IG as the Kullback-Leibler divergence, quantifying how much a new finding changes established knowledge. We used 67 meta-analyses (964 randomized trials) that include one or more trials from any of the three highest IF general medical journals (NEJM, JAMA, and Lancet). We calculated IG for the presence of a non-null effect (IG(1)) and IG for the effect size magnitude (IG(2)). Across meta-analyses, the summary correlation coefficient of IF was 0.23 (95% confidence interval [CI]: 0.14, 0.31) for IG(1) and 0.35 (95% CI: 0.25, 0.46) for IG(2). IF also correlated with the P-value of the results (r=0.18), order of publication (r=-0.13), and number of events in the trial (r=0.36). Multivariate regression including IG, order of publication, P-value, and the number of events showed that IG is an independent correlate of IF. IG(2) explained a substantially larger proportion of the variance in IF than IG(1). Publication in journals with high IF is driven by how extensively the results of a study change prior perceptions of the evidence, independently of the statistical significance and size of the study. Copyright © 2012. Published by Elsevier Inc.

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

    Directory of Open Access Journals (Sweden)

    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.

  2. 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.

  3. Call Center Capacity Planning

    DEFF Research Database (Denmark)

    Nielsen, Thomas Bang

    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 infrastructu...

  4. Call 1 FAQ (ENG)

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

    Francine Sinzinkayo

    What is your definition of “improvement” in this Call for proposals? “Improvement” as used in this call implies all innovations that may be applied by research teams to ... perform their expected roles and to participate in the overall coordination of partnership activities (including monitoring, reporting, communication, etc.).

  5. Callings and Organizational Behavior

    Science.gov (United States)

    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…

  6. Dimensioning large call centers

    NARCIS (Netherlands)

    S.C. Borst (Sem); A. Mandelbaum; M.I. Reiman

    2000-01-01

    textabstractWe develop a framework for asymptotic optimization of a queueing system. The motivation is the staffing problem of call centers with 100's of agents (or more). Such a call center is modeled as an M/M/N queue, where the number of agents~$N$ is large. Within our framework, we determine the

  7. CALL FOR PROPOSALS

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

    Charles

    CALL FOR PROPOSALS. Research Project on: Gender and Enterprise Development in Africa: A Cross-Country Comparative Study. The Institute of Statistical, Social and Economic Research ... calling for research proposals from researchers based in Kenya, Uganda, Mozambique or ... For example, many more women work.

  8. Call 1 FAQ (ENG)

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

    Francine Sinzinkayo

    What is your definition of “improvement” in this Call for proposals? “Improvement” as used in this call implies all innovations that may be applied by research teams to develop a vaccine that is superior to a current one. Examples of improvement are better adjuvant, vaccine delivery systems or formulations that present ...

  9. 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.

  10. The impact of study design on pattern estimation for single-trial multivariate pattern analysis.

    Science.gov (United States)

    Mumford, Jeanette A; Davis, Tyler; Poldrack, Russell A

    2014-12-01

    A prerequisite for a pattern analysis using functional magnetic resonance imaging (fMRI) data is estimating the patterns from time series data, which then are input into the pattern analysis. Here we focus on how the combination of study design (order and spacing of trials) with pattern estimator impacts the Type I error rate of the subsequent pattern analysis. When Type I errors are inflated, the results are no longer valid, so this work serves as a guide for designing and analyzing MVPA studies with controlled false positive rates. The MVPA strategies examined are pattern classification and similarity, utilizing single trial activation patterns from the same functional run. Primarily focusing on the Least Squares Single and Least Square All pattern estimators, we show that collinearities in the models, along with temporal autocorrelation, can cause false positive correlations between activation pattern estimates that adversely impact the false positive rates of pattern similarity and classification analyses. It may seem intuitive that increasing the interstimulus interval (ISI) would alleviate this issue, but remaining weak correlations between activation patterns persist and have a strong influence in pattern similarity analyses. Pattern similarity analyses using only activation patterns estimated from the same functional run of data are susceptible to inflated false positives unless trials are randomly ordered, with a different randomization for each subject. In other cases, where there is any structure to trial order, valid pattern similarity analysis results can only be obtained if similarity computations are restricted to pairs of activation patterns from independent runs. Likewise, for pattern classification, false positives are minimized when the testing and training sets in cross validation do not contain patterns estimated from the same run. Copyright © 2014 Elsevier Inc. All rights reserved.

  11. 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.

  12. A call for better care: the impact of postnatal contact services on women's parenting confidence and experiences of postpartum care in Queensland, Australia

    National Research Council Canada - National Science Library

    Miller, Yvette D; Dane, Aimée C; Thompson, Rachel

    2014-01-01

    .... This study aimed to assess the impact of providing Universal Postnatal Contact Service (UPNCS) funding to public birthing facilities in Queensland, Australia on women's postnatal care experiences, and associations between amount and type...

  13. Where can I call you? The “mobile (phone) revolution” and its impact on survey research and coverage error: A discussion of the Italian case

    OpenAIRE

    Callegaro, Mario; Poggio, Teresio

    2004-01-01

    The increase in mobile phone ownership is changing the sampling frame for landline telephone surveys, with a consequent impact on coverage error. This paper describes the main features of the Italian phone market - characterized by high mobile phone penetration rates - and the rising impact of mobile-phone-only (MPO) households. A survey that uses a landline sampling frame excludes MPO and no-phone households, creating a noncoverage rate of 17% in 2002. Types of phone arrangements and noncove...

  14. The Ghana essential health interventions program: a plausibility trial of the impact of health systems strengthening on maternal & child survival.

    Science.gov (United States)

    Awoonor-Williams, John Koku; Bawah, Ayaga A; Nyonator, Frank K; Asuru, Rofina; Oduro, Abraham; Ofosu, Anthony; Phillips, James F

    2013-01-01

    During the 1990s, researchers at the Navrongo Health Research Centre in northern Ghana developed a highly successful community health program. The keystone of the Navrongo approach was the deployment of nurses termed community health officers to village locations. A trial showed that, compared to areas relying on existing services alone, the approach reduced child mortality by half, maternal mortality by 40%, and fertility by nearly a birth - from a total fertility rate of 5.5 in only five years. In 2000, the government of Ghana launched a national program called Community-based Health Planning and Services (CHPS) to scale up the Navrongo model. However, CHPS scale-up has been slow in districts located outside of the Upper East Region, where the "Navrongo Experiment" was first carried out. This paper describes the Ghana Essential Health Intervention Project (GEHIP), a plausibility trial of strategies for strengthening CHPS, especially in the areas of maternal and newborn health, and generating the political will to scale up the program with strategies that are faithful to the original design. GEHIP improves the CHPS model by 1) extending the range and quality of services for newborns; 2) training community volunteers to conduct the World Health Organization service regimen known as integrated management of childhood illness (IMCI); 3) simplifying the collection of health management information and ensuring its use for decision making; 4) enabling community health nurses to manage emergencies, particularly obstetric complications and refer cases without delay; 5) adding $0.85 per capita annually to district budgets and marshalling grassroots political commitment to financing CHPS implementation; and 6) strengthening CHPS leadership at all levels of the system. GEHIP impact is assessed by conducting baseline and endline survey research and computing the Heckman "difference in difference" test for under-5 mortality in three intervention districts relative to four

  15. Impact of the Baltimore Experience Corps Trial on cortical and hippocampal volumes.

    Science.gov (United States)

    Carlson, Michelle C; Kuo, Julie H; Chuang, Yi-Fang; Varma, Vijay R; Harris, Greg; Albert, Marilyn S; Erickson, Kirk I; Kramer, Arthur F; Parisi, Jeanine M; Xue, Qian-Li; Tan, Eriwn J; Tanner, Elizabeth K; Gross, Alden L; Seeman, Teresa E; Gruenewald, Tara L; McGill, Sylvia; Rebok, George W; Fried, Linda P

    2015-11-01

    There is a substantial interest in identifying interventions that can protect and buffer older adults from atrophy in the cortex and particularly, the hippocampus, a region important to memory. We report the 2-year effects of a randomized controlled trial of an intergenerational social health promotion program on older men's and women's brain volumes. The Brain Health Study simultaneously enrolled, evaluated, and randomized 111 men and women (58 interventions; 53 controls) within the Baltimore Experience Corps Trial to evaluate the intervention impact on biomarkers of brain health at baseline and annual follow-ups during the 2-year trial exposure. Intention-to-treat analyses on cortical and hippocampal volumes for full and sex-stratified samples revealed program-specific increases in volumes that reached significance in men only (P's ≤ .04). Although men in the control arm exhibited age-related declines for 2 years, men in the Experience Corps arm showed a 0.7% to 1.6% increase in brain volumes. Women also exhibited modest intervention-specific gains of 0.3% to 0.54% by the second year of exposure that contrasted with declines of about 1% among women in the control group. These findings showed that purposeful activity embedded within a social health promotion program halted and, in men, reversed declines in brain volume in regions vulnerable to dementia. NCT0038. Copyright © 2015 The Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

  16. Impact of maternal diet on neonatal anthropometry: a randomized controlled trial.

    Science.gov (United States)

    Donnelly, J M; Walsh, J M; Byrne, J; Molloy, E J; McAuliffe, F M

    2015-02-01

    Large for gestational age infants are at increased risk of childhood obesity and maternal nutrition impacts birthweight. The aim of this study was to assess the impact of a maternal low glycaemic index (GI) diet on neonatal anthropometry. The ROLO (Randomised Control Trial of Low Glycaemic Index Diet in Pregnancy) study was a randomized controlled trial to assess the impact of a low GI diet versus usual diet on birthweight. It took place in a tertiary maternity hospital in Ireland and women were randomized to receive either a low GI diet or no dietary intervention from early pregnancy to term. Two hundred sixty-five neonates had anthropometric measurements on day 1-2 of life, 126 in the intervention group and 139 in the control group. Measurements included birthweight, length and circumferences of the head, chest, abdominal, thigh and mid-upper arm. A subgroup of 219 (82%) neonates also had skin-fold measurements. Neonates whose mothers had a low GI diet in pregnancy had lower thigh circumference (15.9 ± 1.7 cm vs. 16.6 ± 1.5 cm, P = 0.04). There was no difference between the intervention and control groups in head, chest abdominal or mid-upper arm circumferences. No difference was noted between the two groups for any skin-fold measurements (subscapular, thigh, biceps and triceps). Neonatal thigh circumference was altered by maternal low GI diet in pregnancy. These findings suggest that maternal low GI diet is safe in pregnancy and may positively impact infant adiposity. © 2014 The Authors. Pediatric Obesity published by John Wiley & Sons Ltd on behalf of International Association for the Study of Obesity.

  17. 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

  18. The Impact of Concomitant Medication Use on Patient Eligibility for Phase I Cancer Clinical Trials

    Directory of Open Access Journals (Sweden)

    Mitesh J. Borad, Kelly K. Curtis, Hani M. Babiker, Martin Benjamin, Raoul Tibes, Ramesh K. Ramanathan, Karen Wright, Amylou C. Dueck, Gayle Jameson, Daniel D. Von Hoff

    2012-01-01

    Full Text Available Concomitant medication (CM use may result in Phase I cancer clinical trial ineligibility due to concern for potential CM-investigational drug interactions or alteration of investigational drug absorption. Few studies have examined the impact of CM use on trial eligibility. Methods: We reviewed records of 274 patients on Phase I trials at a single academic institution. Demographics, CM identities and classes, CM discontinuation, reasons, and incidence of CM substitution were recorded. CM-investigational drug cytochrome P450 (CYP enzyme interactions were documented. Statistical analysis was performed using descriptive statistics. Results: 273 of 274 patients (99.6%, 95% confidence interval [CI] 98.9-100% took CM, with a median of 8 CM per patient (range 0 - 42. CM discontinuation occurred in 67 cases (25%, 95% CI 19-30%. The most common CM classes discontinued were herbal (17 cases, 25%, 95% CI 16-37% and proton pump inhibitors (15 cases, 22%, 95% CI 12-32%. CM discontinuation reasons were: protocol prohibition (32 cases, 48%, 95% CI 36-60%; potential CM-investigational drug interaction (25 cases, 37%, 95% CI 26-49%; other (10 cases, 15%, 95% CI 6-23%. A potential CM-investigational drug CYP interaction was noted in 122 cases (45%, 95% CI 39-50%. CM potentially weakly decreased investigational drug metabolism in 52 cases (43%, 95% CI 34-51%, and potentially strongly decreased investigational drug metabolism in 17 cases (14%, 95% CI 8-20%. Investigational drug potentially weakly decreased CM metabolism in 39 cases (32%, 95% CI 24-40%, and potentially strongly decreased CM metabolism in 28 cases (23%, 95% CI 15-30%. CM substitution occurred in 36/67 cases (54%, 95% CI 41-66% where CM were discontinued to allow for eventual participation in clinical trials. Overall in 2 cases (0.7%, 95% CI 0.1-2.6%, patients were protocol ineligible because CM could not be discontinued or substituted. Conclusions: This study highlights the high prevalence of

  19. 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

  20. 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.

  1. Kindness Curbs Kids' Name-Calling

    Science.gov (United States)

    Saxon, Rebekah

    2005-01-01

    In this article, the author discusses the impact of name-calling towards the student's academic performance and emotions and cites some measures on how should teachers address this problem in order to facilitate effective learning among students. Psychologists recognize that name-calling and other forms of verbal bullying and harassment are more…

  2. A randomized trial Examining The Impact Of Communicating Genetic And Lifestyle Risks For Obesity.

    Science.gov (United States)

    Wang, Catharine; Gordon, Erynn S; Norkunas, Tricia; Wawak, Lisa; Liu, Ching-Ti; Winter, Michael; Kasper, Rachel S; Christman, Michael F; Green, Robert C; Bowen, Deborah J

    2016-12-01

    Genetic testing for obesity is available directly to consumers, yet little is understood about its behavioral impact and its added value to nongenetic risk communication efforts based on lifestyle factors. A randomized trial examined the short-term impact of providing personalized obesity risk information, using a 2 × 2 factorial design. Participants were recruited from the Coriell Personalized Medicine Collaborative (CPMC) and randomized to receive (1) no risk information (control), (2) genetic risk, (3) lifestyle risk, or (4) combined genetic/lifestyle risks. Baseline and 3-month follow-up survey data were collected. Analyses examined the impact of risk feedback on intentions to lose weight and self-reported weight. A total of 696 participants completed the study. A significant interaction effect was observed for genetic and lifestyle information on intent to lose weight (P = 0.0150). Those who received genetic risk alone had greater intentions at follow-up, compared with controls (P = 0.0034). The impact of receiving elevated risk information on intentions varied by source and combination of risks presented. Non-elevated genetic risk did not lower intentions. No group differences were observed for self-reported weight. Genetic risk information for obesity may add value to lifestyle risk information depending on the context in which it is presented. © 2016 The Obesity Society.

  3. Assessing call centers’ success:

    Directory of Open Access Journals (Sweden)

    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

  4. Enhanced nurse call systems.

    Science.gov (United States)

    2001-04-01

    This Evaluation focuses on high-end computerized nurse call systems--what we call enhanced systems. These are highly flexible systems that incorporate microprocessor and communications technologies to expand the capabilities of the nurse call function. Enhanced systems, which vary in configuration from one installation to the next, typically consist of a basic system that provides standard nurse call functionality and a combination of additional enhancements that provide the added functionality the facility desires. In this study, we examine the features that distinguish enhanced nurse call systems from nonenhanced systems, focusing on their application and benefit to healthcare facilities. We evaluated seven systems to determine how well they help (1) improve patient care, as well as increase satisfaction with the care provided, and (2) improve caregiver efficiency, as well as increase satisfaction with the work environment. We found that all systems meet these objectives, but not all systems perform equally well for all implementations. Our ratings will help facilities identify those systems that offer the most effective features for their intended use. The study also includes a Technology Management Guide to help readers (1) determine whether they'll benefit from the capabilities offered by enhanced systems and (2) target a system for purchase and equip the system for optimum performance and cost-effective operation.

  5. Impact of Clinical Trial Results on the Temporal Trends of Carotid Endarterectomy and Stenting From 2002 to 2014

    OpenAIRE

    Hussain, Mohamad A.; Mamdani, Muhammad; Tu, Jack V.; SAPOSNIK, GUSTAVO; Khoushhal, Zeyad; Aljabri, Badr; Verma, Subdoh; Al-Omran, Mohammed

    2016-01-01

    Background and Purpose? Randomized trials provide conflicting data for the efficacy of carotid-artery stenting compared with endarterectomy. The purpose of this study was to examine the impact of conflicting clinical trial publications on the utilization rates of carotid revascularization procedures. Methods? We conducted a population-level time-series analysis of all individuals who underwent carotid endarterectomy and stenting in Ontario, Canada (2002?2014). The primary analysis examined te...

  6. Differential impact of the cheese matrix on the postprandial lipid response: a randomized, crossover, controlled trial.

    Science.gov (United States)

    Drouin-Chartier, Jean-Philippe; Tremblay, André J; Maltais-Giguère, Julie; Charest, Amélie; Guinot, Léa; Rioux, Laurie-Eve; Labrie, Steve; Britten, Michel; Lamarche, Benoît; Turgeon, Sylvie L; Couture, Patrick

    2017-12-01

    Background: In a simulated gastrointestinal environment, the cheese matrix modulates dairy fat digestion. However, to our knowledge, the impact of the cheese matrix on postprandial lipemia in humans has not yet been evaluated.Objective: In healthy subjects, we compared the impact of dairy fat provided from firm cheese, soft cream cheese, and butter on the postprandial response at 4 h and on the incremental area under the curve (iAUC) of plasma triglycerides.Design: Forty-three healthy subjects were recruited to this randomized, crossover, controlled trial. In random order at intervals of 14 d and after a 12-h fast, subjects ingested 33 g fat from a firm cheese (young cheddar), a soft cream cheese (cream cheese), or butter (control) incorporated into standardized meals that were matched for macronutrient content. Plasma concentrations of triglycerides were measured immediately before the meal and 2, 4, 6, and 8 h after the meal.Results: Cheddar cheese, cream cheese, and butter induced similar increases in triglyceride concentrations at 4 h (change from baseline: +59%, +59%, and +62%, respectively; P = 0.9). No difference in the triglyceride iAUC0-8 h (P-meal = 0.9) was observed between the 3 meals. However, at 2 h, the triglyceride response caused by the cream cheese (change from baseline: +44%) was significantly greater than that induced by butter (change from baseline: +24%; P = 0.002) and cheddar cheese (change from baseline: +16%; P = 0.0004). At 6 h, the triglyceride response induced by cream cheese was significantly attenuated compared with that induced by cheddar cheese (change from baseline: +14% compared with +42%; P = 0.0004).Conclusion: This study demonstrates that the cheese matrix modulates the impact of dairy fat on postprandial lipemia in healthy subjects. This trial was registered at clinicaltrials.gov as NCT02623790. © 2017 American Society for Nutrition.

  7. 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

  8. Call Me Sisyphus

    Science.gov (United States)

    2009-02-01

    Gordon MacKenzie (au- thor of Orbiting the Giant Hairball: A Corporate Fool’s Guide to Surviving with Grace) calls a “plum tree structure” and looked at...ghting.” Editor’s note: In Greek mythology , Sisyphus was condemned to an eternity of punishment in Hades that consisted of rolling a huge boulder to

  9. 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.)

  10. Post-call delirium.

    Science.gov (United States)

    Rush, Raphael

    2016-12-01

    Although frequently diagnosed in hospital in-patients, delirium is often recognised but under-reported in the housestaff population. It is estimated that more than 90% of housestaff will experience regular episodes of post-call delirium. This paper identifies diagnostic criteria and discusses approaches to treatment. © 2016 John Wiley & Sons Ltd and The Association for the Study of Medical Education.

  11. 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 ...

  12. CIFSRF 2015 Call Document

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

    wmanchur

    2015-02-02

    Feb 2, 2015 ... Cross-cutting priorities. All proposals seeking funds from this call shall clearly speak to the three CIFSRF cross-cutting priorities: a. Gender equality. Proposals need to demonstrate how the project will include women as important players in the scaling up of innovations, as well as key clients and end users.

  13. An investigation of the impact of Melbourne Zoo's "Seal-the-Loop" donate call-to-action on visitor satisfaction and behavior.

    Science.gov (United States)

    Mellish, Sarah; Sanders, Ben; Litchfield, Carla A; Pearson, Elissa L

    2017-05-01

    Modern zoos are uniquely positioned to educate the public about environmental issues and promote conservation action. This report investigates the introduction of a donation request during an interactive fur seal presentation (as part of Melbourne Zoo's "Seal-the-Loop" initiative) on visitor satisfaction, perceptions of donation as a way to help wild fur seals, and donation behaviors. Comparisons are made between three groups surveyed upon exit: (1) viewed the interactive fur seal presentation prior to the donation request implementation (pledge-presentation: N = 86; see Mellish, Pearson, Sanders, and Litchfield []; International Zoo Yearbook 129:129-154); (2) viewed the interactive fur seal presentation including the donation request (donate-presentation: N = 82); and (3) viewed the fur seal exhibit and donation point but not the presentation and were not directly asked to make a donation (donate-exhibit: N = 82). Findings demonstrate visitor satisfaction with the interactive fur seal presentation was not negatively impacted following the implementation of the donate request (with >92% of pledge-presentation and donate-presentation visitors providing a "satisfied" or "very satisfied" rating). Only the donate-presentation visitors reported donation as a conservation action to help wild fur seals (19.18%; 0% for pledge-presentation visitors). While both donate-exhibit (39.51%) and donate-presentation visitors (60.75%) self-reported making donations or intending to do so, donation behavior was significantly increased for visitors who had viewed the fur seal presentation. Findings provide preliminary support that zoos may utilize interactive educational presentations to effectively ask visitors for donations to support specific conservation projects, without negatively impacting on satisfaction and with a relatively high level of visitor engagement. © 2017 Wiley Periodicals, Inc.

  14. A call for better care: the impact of postnatal contact services on women's parenting confidence and experiences of postpartum care in Queensland, Australia.

    Science.gov (United States)

    Miller, Yvette D; Dane, Aimée C; Thompson, Rachel

    2014-12-20

    Universal postnatal contact services are provided in several Australian states, but their impact on women's postnatal care experience has not been evaluated. Furthermore, there is lack of evidence or consensus about the optimal type and amount of postpartum care after hospital discharge for maternal outcomes. This study aimed to assess the impact of providing Universal Postnatal Contact Service (UPNCS) funding to public birthing facilities in Queensland, Australia on women's postnatal care experiences, and associations between amount and type (telephone or home visits) of contact on parenting confidence, and perceived sufficiency and quality of postnatal care. Data collected via retrospective survey of postnatal women (N = 3,724) were used to compare women who birthed in UPNCS-funded and non-UPNCS-funded facilities on parenting confidence, sufficiency of postnatal care, and perceived quality of postnatal care. Associations between receiving telephone and home visits and the same outcomes, regardless of UPNCS funding, were also assessed. Women who birthed in an UPNCS-funded facility were more likely to receive postnatal contact, but UPNCS funding was not associated with parenting confidence, or perceived sufficiency or perceived quality of care. Telephone contact was not associated with parenting confidence but had a positive dose-response association with perceived sufficiency and quality. Home visits were negatively associated with parenting confidence when 3 or more were received, had a positive dose-response association with perceived sufficiency and were positively associated with perceived quality when at least 6 were received. Funding for UPNCS is unlikely to improve population levels of maternal parenting confidence, perceived sufficiency or quality of postpartum care. Where only minimal contact can be provided, telephone may be more effective than home visits for improving women's perceived sufficiency and quality of care. Additional service initiatives

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

    Science.gov (United States)

    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.

  16. Management of optic neuritis and impact of clinical trials: an international survey

    DEFF Research Database (Denmark)

    Biousse, Valérie; Calvetti, Olivier; Drews-Botsch, Carolyn D

    2009-01-01

    ,443 neurologists and 6,099 ophthalmologists in the southeast-USA, Canada, Australia/New Zealand, Denmark, France, and Thailand. USA data were compared to those of other countries. RESULTS: We collected 3,142 surveys (1,449 neurologists/1,693 ophthalmologists) (29.8% response rate). In all countries, ON patients......-80% of ON patients; lumbar punctures were obtained mostly in Europe and Thailand. Although most patients received acute treatment with intravenous steroids, between 14% and 65% of neurologists and ophthalmologists still recommended oral prednisone (1 mg/kg/day) for the treatment of acute isolated ON. In all...... ON patients according to the best evidence from clinical research. This confirms that evaluation of the impact of major clinical trials ("translational T2 clinical research") is essential when assessing the effects of interventions designed to improve quality of care....

  17. 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 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.

  18. 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...... 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.......  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...

  19. Opening the black box: the impact of an oncology management program consisting of level I pathways and an outbound nurse call system.

    Science.gov (United States)

    Hoverman, J Russell; Klein, Ira; Harrison, Debra W; Hayes, Jad E; Garey, Jody S; Harrell, Robyn; Sipala, Maria; Houldin, Scott; Jameson, Melissa D; Abdullahpour, Mitra; McQueen, Jessica; Nelson, Greg; Verrilli, Diana K; Neubauer, Marcus

    2014-01-01

    The Innovent Oncology Program aims to improve the value of cancer care delivered to patients. McKesson Specialty Health and Texas Oncology (TXO) collaborated with Aetna to launch a pilot program. The study objectives were to evaluate the impact of Innovent on Level I Pathway compliance, implement the Patient Support Services program, and measure the rate and costs associated with chemotherapy-related emergency room (ER) visits and hospital admissions. This was a prospective, nonrandomized evaluation of patients enrolled in Innovent from June 1, 2010, through May 31, 2012. Data from the iKnowMed electronic health record, the McKesson Specialty Health financial data warehouse, and Aetna claims data warehouse were analyzed. A total of 221 patients were included and stratified according to disease and age groups; 76% of ordered regimens were on pathway; 24% were off pathway. Pathway adherence improved from TXO baseline adherence of 63%. Of the 221 patients, 81% enrolled in PSS. Within the breast, colorectal, and lung cancer groups, 14% and 24% of patients had an ER visit and in-patient admission (IPA; baseline) versus 10% and 18% in Innovent, respectively; average in-patient days decreased from 2.1 to 1.2 days, respectively. Total savings combined for the program was $506,481. Implementation of Innovent positively affected patient care in several ways: Fewer ER visits and IPAs occurred, in-patient days decreased, cancer-related use costs were reduced, and on-pathway adherence increased.

  20. A Call for Justice

    OpenAIRE

    Brahmachari, Debahuti

    2015-01-01

    Abstract A new development can be identified within the civil society in Malaysia. A development that has resulted in a general call for justice, voiced through coalition groups that cut across categories of affiliation. This development is triggered by an increasing inculcation of Islamic values into the political system, which has interfered with the understanding of Malaysia as a country that can provide a framework for coexistence within a multicultural society. This thesis seeks ...

  1. Multimodality and CALL

    OpenAIRE

    Guichon, Nicolas; Cohen, Cathy

    2016-01-01

    International audience; This chapter explores the issues pertaining to multimodality, which has always been considered as a defining characteristic of CALL (Chapelle 2009). The chapter begins by critically examining the various definitions of multimodality, especially in the field of second language acquisition and cognitive psychology and explores the distinction between mode, modality and channel. With reference to specific studies conducted in the field, we then investigate the potential o...

  2. 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.

  3. The impact of metrifonate therapy on caregivers of patients with Alzheimer's disease: results from the MALT clinical trial. Metrifonate in Alzheimer's Disease Trial.

    Science.gov (United States)

    Shikiar, R; Shakespeare, A; Sagnier, P P; Wilkinson, D; McKeith, I; Dartigues, J F; Dubois, B

    2000-03-01

    To assess the impact on burden reported by caregivers of patients with mild to moderate Alzheimer's disease (AD) who were treated with metrifonate during a randomized double blind clinical trial. Randomized clinical trial, with a 2-week screening period and a 26-week double blind, placebo controlled, treatment phase. Caregivers were assessed at baseline, at 12 weeks, and at end of trial. Caregivers were interviewed at clinics as part of the assessment of the patients. Six hundred and three caregivers of AD patients who were enrolled in the MALT trial; 591 (98%) provided data suitable for analysis at baseline, and 546 (91%) provided data allowing for inclusion in the analysis of change scores. The Caregiver Burden Assessment consisted of the Screen for Caregiver Burden, including both subjective (SCB-subj) and objective (SCB-obj) scores; the cognitive subscale of Poulshock and Deimling (PD); an abridged version of the Relatives Stress Scale (aRSS); assessments of time spent in providing care, including the Caregiver Activity Time Scale (CATS); and demographic and background variables on both the patient and caregiver. Treatment of mild to moderate AD patients with metrifonate for a duration of 26 weeks significantly reduced the psychological burden of care to the caregivers, as measured by the SCB-subj, the PD, and the aRSS. There were no statistically significant differences on the measures assessing the time spent in caregiving, except for the caregiver's subjective impression of the change in time spent providing care during the trial. When comparing individual dose groups, most of the measures of burden showed the largest benefits in burden for the 60/80 mg group, followed by the 40/50 mg group, and then the placebo group. However, there was no statistically significant dose effect. This study provides the first evidence from a randomized clinical trial of any acetylcholinesterase inhibitor used in the treatment of AD demonstrating a positive impact on the

  4. 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...... the total attitude score (4.8 points) and the randomized clinical trials attitude subscale score (1.8 points). In conclusion, written information significantly improved outpatients' knowledge about and attitude toward randomized clinical trials. Detailed rather than brief information was more effective...

  5. Factors associated with publication of randomized phase iii cancer trials in journals with a high impact factor.

    Science.gov (United States)

    Tang, P A; Pond, G R; Welch, S; Chen, E X

    2014-08-01

    Impact factor (if) is often used as a measure of journal quality. The purpose of the present study was to determine whether trials with positive outcomes are more likely to be published in journals with higher ifs. We reviewed 476 randomized phase iii cancer trials published in 13 journals between 1995 and 2005. Multivariate logistic regression models were used to investigate predictors of publication in journals with high ifs (compared with low and medium ifs). A positive outcome had the strongest association with publication in high-if journals [odds ratio (or): 4.13; 95% confidence interval (ci): 2.67 to 6.37; p impact factor bias," and investigators should be encouraged to submit reports of trials of high methodologic quality to journals with high ifs regardless of study outcomes.

  6. EMPLOYMENT AFTER REHABILITATION FOR MUSCULOSKELETAL IMPAIRMENTS - THE IMPACT OF VOCATIONAL-REHABILITATION AND WORKING ON A TRIAL BASIS

    NARCIS (Netherlands)

    SCHMIDT, SH; OORTMARBURGER, D; MEIJMAN, TF

    1995-01-01

    Objective: To investigate to what extent vocational rehabilitation and working on a trial basis have an impact on employment after rehabilitation. Design: Follow-up survey, conducted in 1991, among all patients, aged 14 to 64, who were treated between 1984 and 1987. Setting: An out-clinic department

  7. 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...

  8. Impact evaluation of the Northern Fruit and Vegetable Pilot Programme - a cluster-randomised controlled trial.

    Science.gov (United States)

    He, Meizi; Beynon, Charlene; Sangster Bouck, Michelle; St Onge, Renée; Stewart, Susan; Khoshaba, Linda; Horbul, Betty A; Chircoski, Bill

    2009-11-01

    The purpose of this impact evaluation was to measure the influence of a government of Ontario, Canada health promotion initiative, the Northern Fruit and Vegetable Pilot Programme (NFVPP), on elementary school-aged children's psychosocial variables regarding fruit and vegetables, and fruit and vegetable consumption patterns. A cluster-randomised controlled trial design was used. The NFVPP consisted of three intervention arms: (i) Intervention I: Free Fruit and Vegetable Snack (FFVS) + Enhanced Nutrition Education; (ii) Intervention II: FFVS-alone; and (iii) Control group. Using the Pro-Children Questionnaire, the primary outcome measure was children's fruit and vegetable consumption, and the secondary outcome measures included differences in children's awareness, knowledge, self-efficacy, preference, intention and willingness to increase fruit and vegetable consumption. Twenty-six elementary schools in a defined area of Northern Ontario were eligible to participate in the impact evaluation. A final sample size of 1,277 students in grades five to eight was achieved. Intervention I students consumed more fruit and vegetables at school than their Control counterparts by 0.49 serving/d (P fruit and vegetables at school than Control students by 0.42 serving/d, although this difference was not statistically significant. Among students in both intervention groups, preferences for certain fruit and vegetables shifted from 'never tried it' towards 'like it'. The NFVPP resulted in positive changes in elementary school-aged children's fruit and vegetable consumption at school, and favourable preference changes for certain fruit and vegetables.

  9. 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

  10. impact of queuing on call c queuing on call c queuing on call ...

    African Journals Online (AJOL)

    eobe

    The concept of queuing is very useful in modell systems where traffic management is of utm importance. In GSM networks, traffic characteris have a random behaviour in terms of arrival; usu following a Poisson's distribution [ deployment of queuing in GSM traffic modelling can very useful in effective channel utilization.

  11. To be called upon

    DEFF Research Database (Denmark)

    Kublitz, Anja

    2015-01-01

    of the responses to the Arab spring among Danish Muslims, this paper will offer some preliminary reflections on how we can understand ‘the mass’ and an ‘intimacy of the mass’ when the mass is no longer a crowd. According to Marx the mass grows quantitatively from the local to the global, but what happens......When Danish Muslims explain what made them decide to travel to the Middle East and take up arms in the wake of the Arab Spring, they say that they were called upon. Displayed on videos on social media, women and sometimes children begged them to come to their rescue. In light of some...

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

    Directory of Open Access Journals (Sweden)

    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

  13. An Island Called Cuba

    Directory of Open Access Journals (Sweden)

    Jean Stubbs

    2011-06-01

    Full Text Available Review of: An Island Called Home: Returning to Jewish Cuba. Ruth Behar, photographs by Humberto Mayol. New Brunswick NJ: Rutgers University Press, 2007. xiii + 297 pp. (Cloth US$ 29.95 Fidel Castro: My Life: A Spoken Autobiography. Fidel Castro & Ignacio Ramonet. New York: Scribner/Simon & Schuster, 2008. vii + 724 pp. (Paper US$ 22.00, e-book US$ 14.99 Cuba: What Everyone Needs to Know. Julia E. Sweig. New York: Oxford University Press, 2009. xiv + 279 pp. (Paper US$ 16.95 [First paragraph] These three ostensibly very different books tell a compelling story of each author’s approach, as much as the subject matter itself. Fidel Castro: My Life: A Spoken Autobiography is based on a series of long interviews granted by the then-president of Cuba, Fidel Castro, to Spanish-Franco journalist Ignacio Ramonet. Cuba: What Everyone Needs to Know, by U.S. political analyst Julia Sweig, is one of a set country series, and, like Ramonet’s, presented in question/answer format. An Island Called Home: Returning to Jewish Cuba, with a narrative by Cuban-American anthropologist Ruth Behar and photographs by Cuban photographer Humberto Mayol, is a retrospective/introspective account of the Jewish presence in Cuba. While from Ramonet and Sweig we learn much about the revolutionary project, Behar and Mayol convey the lived experience of the small Jewish community against that backdrop.

  14. MEDICAL SERVICE - URGENT CALLS

    CERN Document Server

    Service Médical

    2000-01-01

    IN URGENT NEED OF A DOCTOR GENEVA: EMERGENCY SERVICES GENEVA AND VAUD 144 FIRE BRIGADE 118 POLICE 117 CERN FIREMEN 767-44-44 ANTI-POISONS CENTRE Open 24h/24h 01-251-51-51 Patient not fit to be moved, call family doctor, or: GP AT HOME: Open 24h/24h 748-49-50 AMG- Association Of Geneva Doctors: Emergency Doctors at home 07h-23h 322 20 20 Patient fit to be moved: HOPITAL CANTONAL CENTRAL 24 Micheli-du-Crest 372-33-11 ou 382-33-11 EMERGENCIES 382-33-11 ou 372-33-11 CHILDREN'S HOSPITAL 6 rue Willy-Donzé 372-33-11 MATERNITY 32 bvd.de la Cluse 382-68-16 ou 382-33-11 OPHTHALMOLOGY 22 Alcide Jentzer 382-33-11 ou 372-33-11 MEDICAL CENTRE CORNAVIN 1-3 rue du Jura 345 45 50 HOPITAL DE LA TOUR Meyrin 719-61-11 EMERGENCIES 719-61-11 CHILDREN'S EMERGENCIES 719-61-00 LA TOUR MEDICAL CENTRE 719-74-00 European Emergency Call 112   FRANCE: EMERGENCY SERVICES 15 FIRE BRIGADE 18 POLICE 17 CERN FIREMEN AT HOME 00-41-22-767-44-44 ...

  15. Call for volunteers

    CERN Multimedia

    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 ...

  16. Clinical Trials

    Medline Plus

    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 ...

  17. Impact of Adding a Pictorial Display to Enhance Recall of Cancer Patient Histories: A Randomized Trial.

    Science.gov (United States)

    Wolch, Gary; Ghosh, Sunita; Boyington, Curtiss; Watanabe, Sharon M; Fainsinger, Robin; Burton-Macleod, Sarah; Thai, Vincent; Thai, JoAnn; Fassbender, Konrad

    2017-01-01

    Current health care delivery models have increased the need for safe and concise patient handover. Handover interventions in the literature have focused on the use of structured tools but have not evaluated their ability to facilitate retention of patient information. In this study, mock pictorial displays were generated in an attempt to create a snapshot of each patient's medical and social circumstances. These pictorial displays contained the patient's photograph and other disease- and treatment-related images. The objective of this randomized trial was to assess the ability of these snapshots to enhance delayed information recall by care providers. Participating physicians were given four advanced cancer patient histories to review, two at a time over two weeks. Pictorial image displays, referred to as the Electronic Whiteboard (EWB) were added, in a randomized manner to half of the textual histories. The impact of the EWB on information recall was tested in immediate and delayed time frames. Overall, patient information recall declined significantly over time, with or without the EWB. Still, this trial demonstrates significantly higher test scores after 24 hours with the addition of pictures to textual patient information, compared with textual information alone (P = 0.0002). A more modest improvement was seen with the addition of the EWB for questionnaires administered immediately after history review (P = 0.008). Most participants agreed that the EWB was a useful enhancement and that seeing a patient's photograph improved their ability to retain information. Most studies examining the institution of handover protocols in the health care setting have failed to harness the power of pictures and other representative images. This study demonstrates the ability of pictorial displays to improve both immediate and delayed recall of patient histories without increasing review time. These types of displays may be amenable to generation by software programs and

  18. Journal impact factor and methodological quality of surgical randomized controlled trials: an empirical study.

    Science.gov (United States)

    Ahmed Ali, Usama; Reiber, Beata M M; Ten Hove, Joren R; van der Sluis, Pieter C; Gooszen, Hein G; Boermeester, Marja A; Besselink, Marc G

    2017-11-01

    The journal impact factor (IF) is often used as a surrogate marker for methodological quality. The objective of this study is to evaluate the relation between the journal IF and methodological quality of surgical randomized controlled trials (RCTs). Surgical RCTs published in PubMed in 1999 and 2009 were identified. According to IF, RCTs were divided into groups of low (3), as well as into top-10 vs all other journals. Methodological quality characteristics and factors concerning funding, ethical approval and statistical significance of outcomes were extracted and compared between the IF groups. Additionally, a multivariate regression was performed. The median IF was 2.2 (IQR 2.37). The percentage of 'low-risk of bias' RCTs was 13% for top-10 journals vs 4% for other journals in 1999 (P < 0.02), and 30 vs 12% in 2009 (P < 0.02). Similar results were observed for high vs low IF groups. The presence of sample-size calculation, adequate generation of allocation and intention-to-treat analysis were independently associated with publication in higher IF journals; as were multicentre trials and multiple authors. Publication of RCTs in high IF journals is associated with moderate improvement in methodological quality compared to RCTs published in lower IF journals. RCTs with adequate sample-size calculation, generation of allocation or intention-to-treat analysis were associated with publication in a high IF journal. On the other hand, reporting a statistically significant outcome and being industry funded were not independently associated with publication in a higher IF journal.

  19. What Difference Does Patient and Public Involvement Make and What Are Its Pathways to Impact? Qualitative Study of Patients and Researchers from a Cohort of Randomised Clinical Trials.

    Directory of Open Access Journals (Sweden)

    Louise Dudley

    Full Text Available Patient and public involvement (PPI is advocated in clinical trials yet evidence on how to optimise its impact is limited. We explored researchers' and PPI contributors' accounts of the impact of PPI within trials and factors likely to influence its impact.Semi-structured qualitative interviews with researchers and PPI contributors accessed through a cohort of randomised clinical trials. Analysis of transcripts of audio-recorded interviews was informed by the principles of the constant comparative method, elements of content analysis and informant triangulation.We interviewed 21 chief investigators, 10 trial managers and 17 PPI contributors from 28 trials. The accounts of informants within the same trials were largely in agreement. Over half the informants indicted PPI had made a difference within a trial, through contributions that influenced either an aspect of a trial, or how researchers thought about a trial. According to informants, the opportunity for PPI to make a difference was influenced by two main factors: whether chief investigators had goals and plans for PPI and the quality of the relationship between the research team and the PPI contributors. Early involvement of PPI contributors and including them in responsive (e.g. advisory groups and managerial (e.g. trial management groups roles were more likely to achieve impact compared to late involvement and oversight roles (e.g. trial steering committees.Those seeking to enhance PPI in trials should develop goals for PPI at an early stage that fits the needs of the trial, plan PPI implementation in accordance with these goals, invest in developing good relationships between PPI contributors and researchers, and favour responsive and managerial roles for contributors in preference to oversight-only roles. These features could be used by research funders in judging PPI in trial grant applications and to inform policies to optimise PPI within trials.

  20. 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.

  1. Minigrants for Community Health: A Randomized Controlled Trial of Their Impact on Family Food Gardening.

    Science.gov (United States)

    Porter, Christine M; McCrackin, Peggy G; Naschold, Felix

    2016-01-01

    To evaluate the impact of minigrants on home food gardening and review 28 health-related minigrant programs reported in the literature for lessons relevant for using minigrant programs to promote community health. Randomized controlled trial of the impact of minigrants on square footage of food garden area and on garden initiation in 2010 versus 2011. Interviews with participants were also conducted and coded and the literature was reviewed for findings from other community health minigrant programs. Laramie, Wyoming. Sixty adults living in 53 households who attended a gardening training workshop in April 2011. A $40 minigrant in the form of a voucher, valid at a local gardening store. Minigrant recipients were more likely to increase their gardening space than the control group. The average increase for the intervention group was 39.2 ft (3.62 m) while the control group average garden plot size decreased slightly, on average, by 1.4 ft (-0.13 m). However, the data were not normally distributed and, therefore, nonparametric statistical tests were used. For the subset of 20 households that did not garden at all in 2010, minigrants also provided motivation to start gardening (8 of 10 minigrant households started a garden vs 2 of 10 control households). Results reported from other health minigrant programs are also positive, though few had quantitative outcomes or control groups for comparison. Even with very small amounts of money, minigrants show promise as an ethical, inexpensive, empowering, and effective health promotion strategy to enable families and communities to improve their health.

  2. Impact of Clinical Trial Results on the Temporal Trends of Carotid Endarterectomy and Stenting From 2002 to 2014.

    Science.gov (United States)

    Hussain, Mohamad A; Mamdani, Muhammad; Tu, Jack V; Saposnik, Gustavo; Khoushhal, Zeyad; Aljabri, Badr; Verma, Subdoh; Al-Omran, Mohammed

    2016-12-01

    Randomized trials provide conflicting data for the efficacy of carotid-artery stenting compared with endarterectomy. The purpose of this study was to examine the impact of conflicting clinical trial publications on the utilization rates of carotid revascularization procedures. We conducted a population-level time-series analysis of all individuals who underwent carotid endarterectomy and stenting in Ontario, Canada (2002-2014). The primary analysis examined temporal changes in the rates of carotid revascularization procedures after publications of major randomized trials. Secondary analyses examined changes in overall and age, sex, carotid-artery symptom, and operator specialty-specific procedure rates. A total of 16 772 patients were studied (14 394 endarterectomy [86%]; 2378 stenting [14%]). The overall rate of carotid revascularization decreased from 6.0 procedures per 100 000 individuals ≥40 years old in April 2002 to 4.3 procedures in the first quarter of 2014 (29% decrease; Pendarterectomy decreased by 36% (Pcarotid-artery stenting increased by 72% (P=0.006). We observed a marked increase (P=0.01) in stenting after publication of the SAPPHIRE trial (Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy) in 2004, whereas stenting remained relatively unchanged after subsequent randomized trials published in 2006 (P=0.11) and 2010 (P=0.34). In contrast, endarterectomy decreased after trials published in 2006 (P=0.04) and 2010 (P=0.005). Although the overall rates of carotid revascularization and endarterectomy have fallen since 2002, the rate of carotid-artery stenting has risen since the publication of stenting-favorable SAPPHIRE trial. Subsequent conflicting randomized trials were associated with a decreasing rate of carotid endarterectomy. © 2016 The Authors.

  3. The impact of additions in Shona and English consecutively-interpreted rape trials in Zimbabwean courtrooms

    Directory of Open Access Journals (Sweden)

    Svongoro, Paul

    2015-12-01

    Full Text Available This article investigates the conflict between interpreters’ ethical guidelines and the reality in Zimbabwean courtrooms. Although court interpreters’ instructions generally prescribe verbatim translations of original utterances, the reality in the courtroom may demand deviation from what the guidelines prescribe. Focusing on the effect of emphasising and down-toning additions on source language texts in four consecutively-interpreted rape trials heard in Shona and English, this study reveals that court interpreters are aware that their primary goal is to ensure that participants fully understand each other’s intentions. Interpreters therefore adopt a strategy for conveying renditions which would ensure that a speaker’s communicative intention, and not only his/her words, is available to an end receiver. The resultant renditions would nevertheless reveal some additions which may impact on the propositional content and style of the source message and hence the administration of justice. I therefore argue that interpreted courtroom dialogues are essentially ‘three-party’ (Mason, 2000: 9 face-to-face transactions involving two primary speakers and one interpreter.

  4. EPIC Trial: education programme impact on serum phosphorous control in CKD 5D patients on hemodialysis

    Directory of Open Access Journals (Sweden)

    Carmen Tzanno Branco Martins

    Full Text Available Abstract Introduction: In stage 5D chronic kidney disease (CKD 5D patients, the encouragement of treatment adherence by health professionals is a significant clinical challenge. Objectives: This study evaluates the impact of a nutritional education programme on hyperphosphatemia, utilizing the transtheoretical model of behavior change (TMBC. Subjects and Methods: A prospective interventional study comprising 179 CKD 5D patients with hypophosphatemia. The 4-month educational programme took place during dialysis sessions. Demographic and laboratory data were evaluated, whilst the TMBC was utilized both pre- and post-intervention. Results: 132 patients showed a positive change and significant reduction in phosphate levels, whilst 47 patients showed a negative change and little reduction in phosphate levels. Positive changes were identified at different levels of literacy. 117/179 participants had ongoing treatment with sevelamer throughout the trial period. 61 patients with intact parathyroid hormone (iPTH 300 pg/ml also showed a decrease in phosphate levels. Conclusions: Nutritional education programmes can achieve excellent results when appropriately applied. An education programme may be effective across different literacy levels.

  5. Citations for Randomized Controlled Trials in Sepsis Literature: The Halo Effect Caused by Journal Impact Factor.

    Science.gov (United States)

    Zhang, Zhongheng; Poucke, Sven Van

    2017-01-01

    Citations for randomized controlled trials (RCT) are important for the dissemination of study results. However, predictors of citations for RCTs have not been investigated. The study aimed to investigate the predictors of citations for RCTs in sepsis literature. RCTs that investigated the efficacy of treatment strategies on clinical outcomes in sepsis patients were included, and publication dates were restricted to the period from 2000 to 2016. Risk of bias was assessed using the Cochrane handbook for systematic reviews and interventions. A multivariable linear regression model was built to investigate the independent variables associated with total citations. In total, 160 RCTs met our inclusion criteria and were included for analysis. The median of total citations was 28.5 (IQR: 6-76). The journal impact factor (IF) for articles was 6.312 (IQR: 3.143-7.214). The dependent variable was transformed by the square root to improve normality and meet the assumption of homoscedasticity. The journal IF (coefficient: 0.2; 95% CI: 0.16, 0.25) was independently associated with total citations. Large samples were associated with more total citations (coefficient: 0.0026; 95% CI: 0.0013, 0.0039). The study demonstrated that the journal IF was a major determinant of the RCT's total citation number.

  6. Impact of implementation and conduct of the HEALTHY primary prevention trial on student performance.

    Science.gov (United States)

    Hernandez, Arthur E; Marcus, Marsha D; Hirst, Kathryn; Faith, Myles S; Goldberg, Linn; Treviño, Roberto P

    2014-01-01

    To determine whether a school-wide intervention program to reduce risk factors for type 2 diabetes (T2D) affected student achievement, rates of disciplinary actions, and attendance rates. The HEALTHY primary prevention trial was designed to evaluate a comprehensive school-based intervention to reduce factors for T2D, especially overweight and obesity. Students were followed up from beginning of sixth grade (Fall 2006) through end of eighth grade (Spring 2009). Forty-two middle schools at seven U.S. sites. Schools were randomized in equal numbers at each site to intervention (21 schools, 2307 students) or control (21 schools, 2296 students). Intervention . An integrated school-wide program that focused on (1) foods and beverages, (2) physical education, (3) classroom-based behavior change and education, and (4) social marketing communication and promotional campaigns. Aggregate (grade- and school-wide) test performance (passing rate), attendance, and referrals for disciplinary actions. Descriptive statistics and tests of intervention versus control using mixed linear models methods to adjust for the clustering of students within schools. There were no differences between intervention and control schools in test performance for mathematics (p = .7835) or reading (p = .6387), attendance (p = .5819), or referrals for disciplinary action (p = .8671). The comprehensive HEALTHY intervention and associated research procedures did not negatively impact student achievement test scores, attendance, or referrals for disciplinary action.

  7. A randomized trial of the Hawaii SunSmart program's impact on outdoor recreation staff.

    Science.gov (United States)

    Glanz, K; Maddock, J E; Lew, R A; Murakami-Akatsuka, L

    2001-06-01

    Skin cancer is the most common form of cancer in the United States and one of the most preventable. Prevention programs for children at outdoor recreation sites may influence not only the youth, but the staff, or caregivers, as well. By teaching children about sun protection, staff may also change their sun protection behaviors. We report on the impact of a childhood skin cancer prevention program (SunSmart) on staff at outdoor recreation sites where a child-focused intervention was conducted. The intervention included staff training, on-site activities delivered by staff, distribution of sunscreen, and the promotion of sun-safe environments. It was hypothesized that by teaching children about sun protection, staff would change their sun protection behaviors. A randomized trial at 14 recreation sites (n = 176 staff) in Hawaii tested the efficacy of education only, and education plus environmental changes, compared with a control condition. Results showed significant positive changes in knowledge, sun protection habits, norms, and sun protection policies. The education plus environment group was not superior to education alone. Changes in staff behavior and attitudes are important for their own health, as positive role models, and for the dissemination of skin cancer control programs.

  8. 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 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.

  9. Impact of a web-based tool (WebCONSORT) to improve the reporting of randomised trials: results of a randomised controlled trial.

    Science.gov (United States)

    Hopewell, Sally; Boutron, Isabelle; Altman, Douglas G; Barbour, Ginny; Moher, David; Montori, Victor; Schriger, David; Cook, Jonathan; Gerry, Stephen; Omar, Omar; Dutton, Peter; Roberts, Corran; Frangou, Eleni; Clifton, Lei; Chiocchia, Virginia; Rombach, Ines; Wartolowska, Karolina; Ravaud, Philippe

    2016-11-28

    The CONSORT Statement is an evidence-informed guideline for reporting randomised controlled trials. A number of extensions have been developed that specify additional information to report for more complex trials. The aim of this study was to evaluate the impact of using a simple web-based tool (WebCONSORT, which incorporates a number of different CONSORT extensions) on the completeness of reporting of randomised trials published in biomedical publications. We conducted a parallel group randomised trial. Journals which endorsed the CONSORT Statement (i.e. referred to it in the Instruction to Authors) but do not actively implement it (i.e. require authors to submit a completed CONSORT checklist) were invited to participate. Authors of randomised trials were requested by the editor to use the web-based tool at the manuscript revision stage. Authors registering to use the tool were randomised (centralised computer generated) to WebCONSORT or control. In the WebCONSORT group, they had access to a tool allowing them to combine the different CONSORT extensions relevant to their trial and generate a customised checklist and flow diagram that they must submit to the editor. In the control group, authors had only access to a CONSORT flow diagram generator. Authors, journal editors, and outcome assessors were blinded to the allocation. The primary outcome was the proportion of CONSORT items (main and extensions) reported in each article post revision. A total of 46 journals actively recruited authors into the trial (25 March 2013 to 22 September 2015); 324 author manuscripts were randomised (WebCONSORT n = 166; control n = 158), of which 197 were reports of randomised trials (n = 94; n = 103). Over a third (39%; n = 127) of registered manuscripts were excluded from the analysis, mainly because the reported study was not a randomised trial. Of those included in the analysis, the most common CONSORT extensions selected were non-pharmacologic (n = 43; n

  10. A paradigm called magnetism

    CERN Document Server

    Dattagupta, Sushanta

    2008-01-01

    This book provides an overview of how diverse issues of Magnetism have implications for other areas of physics. Attention will be drawn to different aspects of many-body physics, which first appeared in Magnetism but have had deep impact in different branches of physics. Each of these aspects will be illustrated schematically and in terms of physical examples, chosen from multicritical phenomena, quantum phase transition, spin glasses, relaxation, phase ordering and quantum dissipation. A unique feature of this book is a unified and coherent discussion of magnetic phenomena, presented in a luc

  11. Impact of non-uniform correlation structure on sample size and power in multiple-period cluster randomised trials.

    Science.gov (United States)

    Kasza, J; Hemming, K; Hooper, R; Matthews, Jns; Forbes, A B

    2017-01-01

    Stepped wedge and cluster randomised crossover trials are examples of cluster randomised designs conducted over multiple time periods that are being used with increasing frequency in health research. Recent systematic reviews of both of these designs indicate that the within-cluster correlation is typically taken account of in the analysis of data using a random intercept mixed model, implying a constant correlation between any two individuals in the same cluster no matter how far apart in time they are measured: within-period and between-period intra-cluster correlations are assumed to be identical. Recently proposed extensions allow the within- and between-period intra-cluster correlations to differ, although these methods require that all between-period intra-cluster correlations are identical, which may not be appropriate in all situations. Motivated by a proposed intensive care cluster randomised trial, we propose an alternative correlation structure for repeated cross-sectional multiple-period cluster randomised trials in which the between-period intra-cluster correlation is allowed to decay depending on the distance between measurements. We present results for the variance of treatment effect estimators for varying amounts of decay, investigating the consequences of the variation in decay on sample size planning for stepped wedge, cluster crossover and multiple-period parallel-arm cluster randomised trials. We also investigate the impact of assuming constant between-period intra-cluster correlations instead of decaying between-period intra-cluster correlations. Our results indicate that in certain design configurations, including the one corresponding to the proposed trial, a correlation decay can have an important impact on variances of treatment effect estimators, and hence on sample size and power. An R Shiny app allows readers to interactively explore the impact of correlation decay.

  12. Impact of probiotics in women with gestational diabetes mellitus on metabolic health: a randomized controlled trial.

    Science.gov (United States)

    Lindsay, Karen L; Brennan, Lorraine; Kennelly, Maria A; Maguire, Orla C; Smith, Thomas; Curran, Sinead; Coffey, Mary; Foley, Michael E; Hatunic, Mensud; Shanahan, Fergus; McAuliffe, Fionnuala M

    2015-04-01

    Probiotics are live microorganisms that may confer health benefits on the host. Recent trials of probiotic use among healthy pregnant women demonstrate potential for improved glycemic control. The aim of this study was to investigate the effects of a probiotic capsule intervention on maternal metabolic parameters and pregnancy outcome among women with gestational diabetes. This double-blind placebo-controlled randomized trial recruited pregnant women with a new diagnosis of gestational diabetes or impaired glucose tolerance following a 3-hour 100-g glucose tolerance test. Women were randomized to a daily probiotic (Lactobacillus salivarius UCC118) or placebo capsule from diagnosis until delivery. Fasting blood samples were collected at baseline and 4-6 weeks after capsule commencement for analysis of glucose, insulin, c-peptide, and lipids. The primary outcome was difference in fasting glucose postintervention, first analyzed on an intention-to-treat basis and followed by per-protocol analysis that excluded women commenced on pharmacological therapy (insulin or metformin). Secondary outcomes were changes in insulin, c-peptide, homeostasis model assessment and lipids, requirement for pharmacological therapy, and neonatal anthropometry. Of 149 women recruited and randomized, there were no differences between the probiotic and placebo groups in postintervention fasting glucose (4.65 ± 0.49 vs 4.65 ± 0.53 mmol/L; P = 373), requirement for pharmacological therapy (17% vs 14%; P = .643), or birthweight (3.57 ± 0.64 vs 3.60 ± 0.57 kg; P = .845). Among 100 women managed with diet and exercise alone, fasting plasma glucose decreased significantly within both the probiotic (4.76 ± 0.45 to 4.57 ± 0.42 mmol/L; P probiotic vs the placebo group (+0.27 ± 0.48 vs +0.50 ± 0.52 mmol/L total cholesterol, P = .031; +0.08 ± 0.51 vs +0.31 ± 0.45 mmol/L LDL cholesterol, P = .011). No differences were noted between groups in other metabolic parameters or pregnancy

  13. The Public Health Impact of the So-Called "Fluad Effect" on the 2014/2015 Influenza Vaccination Campaign in Italy: Ethical Implications for Health-Care Workers and Health Communication Practitioners.

    Science.gov (United States)

    Rosselli, Roberto; Martini, Mariano; Bragazzi, Nicola Luigi; Watad, Abdulla

    2017-01-01

    Seasonal influenza, causing complications, hospitalizations and deaths, generates a serious socio-economic burden, especially among elderly and high-risk subjects, as well as among adult individuals. Despite the availability and active free-of charge offer of influenza vaccines, vaccine coverage rates remain low and far from the target established by the Ministry of Health. Notwithstanding their effectiveness, vaccines are victims of prejudices and false myths, that contribute to the increasing phenomenon of vaccine hesitancy and loss of confidence. Media and, in particular, new media and information and communication technologies (ICTs) play a major role in disseminating health-related information. They are extremely promising devices for delivering health education and promoting disease prevention, including immunization. However, they can also have a negative impact on population's health attitudes and behaviors when channeling wrong, misleading information. During the 2014/2015 influenza vaccination campaign, the report of four deaths allegedly caused by administration of an adjuvanted influenza vaccine, Fluad - the so-called "Fluad case" - received an important media coverage, which contributed to the failure of the vaccination campaign, dramatically reducing the influenza vaccine uptake. In the extant literature, there is a dearth of information concerning the effect of the "Fluad case". The current study aims at quantifying the impact of the "Fluad effect" at the level of the Local Health Unit 3 (LHU3) ASL3 Genovese, Genoa, Italy. Ethical implications for health-care workers and health communication practitioners are also envisaged.

  14. 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)

  15. 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.

  16. Clinical trials and E-health: impact of new information technology applied to clinical trials (including source data-medical records) and to human and drug research.

    Science.gov (United States)

    Béhier, Jehan-Michel; Reynier, Jean-Charles; Bertoye, Pierre-Henri; Vray, Muriel

    2010-01-01

    Within the last few years, new technology has come to play an important part in our professional and private daily environment. Healthcare has not escaped this progressive mutation with computers reaching the bedside. Clinical research has also shown growing interest in these new tools available to the clinical investigator, the patient, as well as to specialist departments for diagnosis and follow-up of patients, and to the different professions in clinical research. If the use of new technology seems to make life easier, by centralizing data or by simplifying data-sharing between different teams, it is still a matter of private data which must remain reliable, confidential and secure, whether it is being used in ordinary healthcare or in academic or industrial research. The aim of the round table was to estimate the impact of new information technology applied to clinical trials (including source data-medical records) and to human and drug research. First, an inventory was made of the development of these new technologies in the healthcare system. The second point developed was identification of expected benefits in order to issue guidelines for their good use and hazard warnings in clinical trials. Finally, the impact of these new technologies on the investigator as well as the project manager was analysed. © 2010 Société Française de Pharmacologie et de Thérapeutique.

  17. Brief alcohol intervention trials conducted by higher prestige authors and published in higher impact factor journals are cited more frequently.

    Science.gov (United States)

    Tanner-Smith, Emily E; Polanin, Joshua R

    2016-07-01

    To examine the relationships between study quality, author prestige, journal impact factors, and citation rates of trials and to examine whether journal impact factors mediated the relationships between study quality and author prestige on citation rates. We used bibliometric data from 128 controlled trials included in a recent meta-analysis on brief alcohol interventions for adolescents and young adults. We obtained the number of citations from ISI Web of Knowledge and Google Scholar; journal impact factors were obtained from ISI Web of Knowledge. Linear regression models were used to examine the direct and indirect effects of interest. The results indicated that studies were published in journals with higher impact factors when first authors had higher h-indices and studies were funded, but this was largely because those studies were of higher quality. Studies were cited more frequently when first authors had higher h-indices and studies were funded, even after adjusting for study quality proxies. The observed associations between study quality and author prestige on citation rates were also partly mediated through journal impact factors. We conclude that studies conducted by more established authors and reported in more prestigious journal outlets are more likely to be cited by other scholars, even after controlling for various proxies of study quality. Copyright © 2016 Elsevier Inc. All rights reserved.

  18. The impact of the Virtual Ophthalmology Clinic on medical students' learning: a randomised controlled trial

    Science.gov (United States)

    Succar, T; Zebington, G; Billson, F; Byth, K; Barrie, S; McCluskey, P; Grigg, J

    2013-01-01

    Aim The Virtual Ophthalmology Clinic (VOC) is an interactive web-based teaching module, with special emphasis on history taking and clinical reasoning skills. The purpose of this study was to determine the impact of VOC on medical students' learning. Methods A randomised controlled trial (RCT) was conducted with medical students from the University of Sydney (n=188) who were randomly assigned into either an experimental (n=93) or a control group (n=95). A pre- and post-test and student satisfaction questionnaire were administered. Twelve months later a follow-up test was conducted to determine the long-term retention rate of graduates. Results There was a statistically significant (P<0.001) within-subject improvement pre- to post rotation in the number of correctly answered questions for both the control and experimental groups (mean improvement for control 10%, 95% CI 1.3–2.6, and for experimental 17.5%, 95% CI 3.0–4.0). The improvement was significantly greater in the experimental group (mean difference in improvement between groups 7.5%, 95% CI 0.8–2.3, P<0.001). At 12 months follow-up testing, the experimental group scored on average 1.6 (8%) (95%CI 0.4 to 2.7, P=0.007) higher than the controls. Conclusion On the basis of a statistically significant improvement in academic performance and highly positive student feedback, the implementation of VOC may provide a means to address challenges to ophthalmic learning outcomes in an already crowded medical curriculum. PMID:23867718

  19. Yoga's impact on inflammation, mood, and fatigue in breast cancer survivors: a randomized controlled trial.

    Science.gov (United States)

    Kiecolt-Glaser, Janice K; Bennett, Jeanette M; Andridge, Rebecca; Peng, Juan; Shapiro, Charles L; Malarkey, William B; Emery, Charles F; Layman, Rachel; Mrozek, Ewa E; Glaser, Ronald

    2014-04-01

    To evaluate yoga's impact on inflammation, mood, and fatigue. A randomized controlled 3-month trial was conducted with two post-treatment assessments of 200 breast cancer survivors assigned to either 12 weeks of 90-minute twice per week hatha yoga classes or a wait-list control. The main outcome measures were lipopolysaccharide-stimulated production of proinflammatory cytokines interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-α), and interleukin-1β (IL-1β), and scores on the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), the vitality scale from the Medical Outcomes Study 36-item Short Form (SF-36), and the Center for Epidemiological Studies-Depression (CES-D) scale. Immediately post-treatment, fatigue was not lower (P > .05) but vitality was higher (P = .01) in the yoga group compared with the control group. At 3 months post-treatment, fatigue was lower in the yoga group (P = .002), vitality was higher (P = .01), and IL-6 (P = .027), TNF-α (P = .027), and IL-1β (P = .037) were lower for yoga participants compared with the control group. Groups did not differ on depression at either time (P > .2). Planned secondary analyses showed that the frequency of yoga practice had stronger associations with fatigue at both post-treatment visits (P = .019; P .05) than simple group assignment; more frequent practice produced larger changes. At 3 months post-treatment, increasing yoga practice also led to a decrease in IL-6 (P = .01) and IL-1β (P = .03) production but not in TNF-α production (P > .05). Chronic inflammation may fuel declines in physical function leading to frailty and disability. If yoga dampens or limits both fatigue and inflammation, then regular practice could have substantial health benefits.

  20. The impact of immunoglobulin in acute HIV infection on the HIV reservoir: a randomized controlled trial.

    Science.gov (United States)

    Tiraboschi, J; Ray, S; Patel, K; Teague, A; Pace, M; Phalora, P; Robinson, N; Hopkins, E; Meyerowitz, J; Wang, Y; Cason, J; Kaye, S; Sanderson, J; Klenerman, P; Fidler, S; Frater, J; Fox, J

    2017-11-01

    Antiretroviral therapy (ART) during acute HIV infection (AHI) restricts the HIV reservoir, but additional interventions are necessary to induce a cure. Intravenous immunoglobulin (IVIG) is not HIV-specific but is safe and temporarily reduces the HIV reservoir in chronic HIV infection. We present a randomized controlled trial to investigate whether IVIG plus ART in AHI reduces the HIV reservoir and immune activation compared with ART alone. Ten men with AHI (Fiebig II-IV) initiated ART (tenofovir, entricitabine, ritonavir boosted darunavir and raltegravir) at HIV-1 diagnosis and were randomized to ART alone or ART plus 5 days of IVIG, once virally suppressed (week 19). Blood samples were evaluated for viral reservoir, immune activation, immune exhaustion and microbial translocation. Flexible sigmoidoscopy was performed at weeks 19, 24 and 48, and gut proviral DNA and cell numbers determined. IVIG was well tolerated and no viral blips (> 50 HIV-1 RNA copies/mL) occurred during IVIG therapy. From baseline to week 48, total HIV DNA in peripheral blood mononuclear cells (PBMCs) (cases: -3.7 log 10 copies/10 6 CD4 cells; controls: -3.87 log 10 copies/10 6 CD4 cells) declined with no differences observed between the groups (P = 0.49). Declines were observed in both groups from week 19 to week 48 in total HIV DNA in PBMCs (P = 0.38), serum low copy RNA (P = 0.57) and gut total HIV DNA (P = 0.55), but again there were no significant differences between arms. Biomarkers of immune activation, immune exhaustion and microbial translocation and the CD4:CD8 ratio were similar between arms for all comparisons. Although safe, IVIG in AHI did not impact total HIV DNA, immune function or microbial translocation in peripheral blood or gut tissue. © 2017 British HIV Association.

  1. Impact of a board-game approach on current smokers: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Khazaal Yasser

    2013-01-01

    Full Text Available Abstract Background The main objective of our study was to assess the impact of a board game on smoking status and smoking-related variables in current smokers. To accomplish this objective, we conducted a randomized controlled trial comparing the game group with a psychoeducation group and a waiting-list control group. Methods The following measures were performed at participant inclusion, as well as after a 2-week and a 3-month follow-up period: “Attitudes Towards Smoking Scale” (ATS-18, “Smoking Self-Efficacy Questionnaire” (SEQ-12, “Attitudes Towards Nicotine Replacement Therapy” scale (ANRT-12, number of cigarettes smoked per day, stages of change, quit attempts, and smoking status. Furthermore, participants were assessed for concurrent psychiatric disorders and for the severity of nicotine dependence with the Fagerström Test for Nicotine Dependence (FTND. Results A time × group effect was observed for subscales of the ANRT-12, ATS-18 and SEQ-12, as well as for the number of cigarettes smoked per day. At three months follow-up, compared to the participants allocated to the waiting list group, those on Pick-Klop group were less likely to remain smoker. Outcomes at 3 months were not predicted by gender, age, FTND, stage of change, or psychiatric disorders at inclusion. Conclusions The board game seems to be a good option for smokers. The game led to improvements in variables known to predict quitting in smokers. Furthermore, it increased smoking-cessation rates at 3-months follow-up. The game is also an interesting alternative for smokers in the precontemplation stage.

  2. Impact of a board-game approach on current smokers: a randomized controlled trial.

    Science.gov (United States)

    Khazaal, Yasser; Chatton, Anne; Prezzemolo, Roberto; Zebouni, Fadi; Edel, Yves; Jacquet, Johan; Ruggeri, Ornella; Burnens, Emilie; Monney, Grégoire; Protti, Anne-Sylvie; Etter, Jean-François; Khan, Riaz; Cornuz, Jacques; Zullino, Daniele

    2013-01-17

    The main objective of our study was to assess the impact of a board game on smoking status and smoking-related variables in current smokers. To accomplish this objective, we conducted a randomized controlled trial comparing the game group with a psychoeducation group and a waiting-list control group. The following measures were performed at participant inclusion, as well as after a 2-week and a 3-month follow-up period: "Attitudes Towards Smoking Scale" (ATS-18), "Smoking Self-Efficacy Questionnaire" (SEQ-12), "Attitudes Towards Nicotine Replacement Therapy" scale (ANRT-12), number of cigarettes smoked per day, stages of change, quit attempts, and smoking status. Furthermore, participants were assessed for concurrent psychiatric disorders and for the severity of nicotine dependence with the Fagerström Test for Nicotine Dependence (FTND). A time × group effect was observed for subscales of the ANRT-12, ATS-18 and SEQ-12, as well as for the number of cigarettes smoked per day. At three months follow-up, compared to the participants allocated to the waiting list group, those on Pick-Klop group were less likely to remain smoker.Outcomes at 3 months were not predicted by gender, age, FTND, stage of change, or psychiatric disorders at inclusion. The board game seems to be a good option for smokers. The game led to improvements in variables known to predict quitting in smokers. Furthermore, it increased smoking-cessation rates at 3-months follow-up. The game is also an interesting alternative for smokers in the precontemplation stage.

  3. The impact of disulfiram treatment on the reinforcing effects of cocaine: a randomized clinical trial.

    Directory of Open Access Journals (Sweden)

    Colin N Haile

    Full Text Available 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.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.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.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.Clinicaltrials.gov NCT00729300.

  4. The impact of the Virtual Ophthalmology Clinic on medical students' learning: a randomised controlled trial.

    Science.gov (United States)

    Succar, T; Zebington, G; Billson, F; Byth, K; Barrie, S; McCluskey, P; Grigg, J

    2013-10-01

    The Virtual Ophthalmology Clinic (VOC) is an interactive web-based teaching module, with special emphasis on history taking and clinical reasoning skills. The purpose of this study was to determine the impact of VOC on medical students' learning. A randomised controlled trial (RCT) was conducted with medical students from the University of Sydney (n=188) who were randomly assigned into either an experimental (n=93) or a control group (n=95). A pre- and post-test and student satisfaction questionnaire were administered. Twelve months later a follow-up test was conducted to determine the long-term retention rate of graduates. There was a statistically significant (P<0.001) within-subject improvement pre- to post rotation in the number of correctly answered questions for both the control and experimental groups (mean improvement for control 10%, 95% CI 1.3-2.6, and for experimental 17.5%, 95% CI 3.0-4.0). The improvement was significantly greater in the experimental group (mean difference in improvement between groups 7.5%, 95% CI 0.8-2.3, P<0.001). At 12 months follow-up testing, the experimental group scored on average 1.6 (8%) (95%CI 0.4 to 2.7, P=0.007) higher than the controls. On the basis of a statistically significant improvement in academic performance and highly positive student feedback, the implementation of VOC may provide a means to address challenges to ophthalmic learning outcomes in an already crowded medical curriculum.

  5. Impact of patient access to Internet health records on glaucoma medication: randomized controlled trial.

    Science.gov (United States)

    Kashiwagi, Kenji; Tsukahara, Shigeo

    2014-01-15

    Glaucoma is one of the leading causes of blindness. Reduction of intraocular pressure is the only proven way to prevent progression of glaucomatous optic neuropathy. The majority of glaucoma patients need to use antiglaucoma ophthalmic solutions over the course of their life. Thus, good adherence and persistency of glaucoma treatment are important factors for better glaucoma care. The purpose of this study was to investigate the impact of an Internet-based glaucoma care support system on glaucoma medication use. Patients were randomly divided into two groups. The non-Internet access (NIA) group consisted of patients who had access to the Internet-based glaucoma care support system during the 4-year period only when they were examined by ophthalmologists. The Internet access (IA) group consisted of patients who had the same Internet-based glaucoma care support system access as the NIA group for the first 2 years following enrollment but who were also given free access to the glaucoma care support system for the remaining 2 years. Changes in glaucoma medication use were investigated. In total, 81 patients in the IA group and 90 patients in the NIA group satisfied the study protocol. The number of antiglaucoma ophthalmic solutions used during the study period significantly increased in the NIA group (PInternet access significantly shifted from an increasing intraocular pressure trend to a decreasing trend in the IA group (P=.002) among the patients who did not have any medication changes. Allowing patients to browse their medical data may reduce the use and improve the effectiveness of glaucoma medication. UMIN-CTR Clinical Trial Number: UMIN000006982; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000008238&language=E (Archived by WebCite at http://www.webcitation.org/6MRPQeEAv).

  6. Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers

    NARCIS (Netherlands)

    O’Cathain, A.; Hoddinott, P.; Lewin, S.; Thomas, K.J.; Young, B.; Adamson, J.; Jansen, J.F.M.; Mills, N.; Moore, G.; Donovan, J.L.

    2015-01-01

    Feasibility studies are increasingly undertaken in preparation for randomised controlled trials in order to explore uncertainties and enable trialists to optimise the intervention or the conduct of the trial. Qualitative research can be used to examine and address key uncertainties prior to a full

  7. 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

  8. Behavior based adaptive call predictor

    OpenAIRE

    Phithakkitnukoon, Santi; Dantu, Ram; Claxton, Rob; Eagle, Nathan

    2011-01-01

    Predicting future calls can be the next advanced feature of the next-generation telecommunication networks as the service providers are looking to offer new services to their customers. Call prediction can be useful to many applications such as planning daily schedules, avoiding unwanted communications (e.g. voice spam), and resource planning in call centers. Predicting calls is a very challenging task. We believe that this is an emerging area of research in ambient intelligence where the ele...

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

    DEFF Research Database (Denmark)

    Lundh, Andreas; Barbateskovic, Marija; Hróbjartsson, Asbjørn

    2010-01-01

    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 journa....... We investigated industry-supported trials' influence on journal impact factors and revenue....

  10. Impact on mortality and cancer incidence rates of using random invitation from population registers for recruitment to trials

    Directory of Open Access Journals (Sweden)

    Woolas Robert

    2011-03-01

    Full Text Available Abstract Background Participants in trials evaluating preventive interventions such as screening are on average healthier than the general population. To decrease this 'healthy volunteer effect' (HVE women were randomly invited from population registers to participate in the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS and not allowed to self refer. This report assesses the extent of the HVE still prevalent in UKCTOCS and considers how certain shortfalls in mortality and incidence can be related to differences in socioeconomic status. Methods Between 2001 and 2005, 202 638 postmenopausal women joined the trial out of 1 243 312 women randomly invited from local health authority registers. The cohort was flagged for deaths and cancer registrations and mean follow up at censoring was 5.55 years for mortality, and 2.58 years for cancer incidence. Overall and cause-specific Standardised Mortality Ratios (SMRs and Standardised Incidence Ratios (SIRs were calculated based on national mortality (2005 and cancer incidence (2006 statistics. The Index of Multiple Deprivation (IMD 2007 was used to assess the link between socioeconomic status and mortality/cancer incidence, and differences between the invited and recruited populations. Results The SMR for all trial participants was 37%. By subgroup, the SMRs were higher for: younger age groups, extremes of BMI distribution and with each increasing year in trial. There was a clear trend between lower socioeconomic status and increased mortality but less pronounced with incidence. While the invited population had higher mean IMD scores (more deprived than the national average, those who joined the trial were less deprived. Conclusions Recruitment to screening trials through invitation from population registers does not prevent a pronounced HVE on mortality. The impact on cancer incidence is much smaller. Similar shortfalls can be expected in other screening RCTs and it maybe prudent

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

    Science.gov (United States)

    Suñé, Pilar; Suñé, Josep Maria; Montoro, J Bruno

    2013-01-01

    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. 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 (pimpact 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). Clinical trials with positive outcomes have significantly higher rates and shorter times to publication than those with negative results. However, no differences have been found in terms of impact factor.

  12. 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.

  13. Impact of heart rate on central hemodynamics and stroke: a meta-analysis of β-blocker trials.

    Science.gov (United States)

    Ding, Feng-Hua; Li, Yan; Li, Li-Hua; Wang, Ji-Guang

    2013-01-01

    In a meta-analysis, we investigated effects of β-blockers on central hemodynamic measurements and explored the impact of heart rate (HR) on central hemodynamics and the risk of stroke. We searched randomized controlled trials that compared β-blockers with other classes of antihypertensive drugs in reducing central systolic blood pressure (cSBP) and augmentation index (cAI) and in preventing stroke. A random-effects model was used to compute pooled estimates. In 9 trials (n = 754), β-blockers were less efficacious in reducing cAI than all the other classes of drugs (8.6%, P classes of drugs (P ≥ 0.50). In a meta-regression analysis of these 9 trials, the baseline-adjusted difference in HR between randomized groups was associated with cAI (7.0% increase for each 10 bpm decrease in HR, P = 0.02), which was associated with cSBP (1.2 mm Hg increase for each 1% increase in cAI, P = 0.009). In 5 outcome trials, the pooled OR of stroke was 1.23 (P meta-regression analysis. Slowing HR with β-blockers may increase cAI and in turn may decrease cSBP less than with other classes of drugs. This mechanism might account for a smaller reduction in the risk of stroke when using β-blockers to treat hypertension.

  14. Impact of using a local protocol in preoperative testing: blind randomized clinical trial.

    Science.gov (United States)

    Santos, Mônica Loureiro; Iglesias, Antônio Carlos

    2017-01-01

    to evaluate the impact of the use of a local protocol of preoperative test requests in reducing the number of exams requested and in the occurrence of changes in surgical anesthetic management and perioperative complications. we conducted a randomized, blinded clinical trial at the Gaffrée and Guinle University Hospital with 405 patients candidates for elective surgery randomly divided into two groups, according to the practice of requesting preoperative exams: a group with non-selectively requested exams and a protocol group with exams requested according to the study protocol. Studied exams: complete blood count, coagulogram, glycemia, electrolytes, urea and creatinine, ECG and chest X-ray. Primary outcomes: changes in surgical anesthetic management caused by abnormal exams, reduction of the number of exams requested after the use of the protocol and perioperative complications. there was a significant difference (pradiografia de tórax. Desfechos primários: alterações na conduta anestésico-cirúrgica motivadas por exames anormais, redução do número de exames solicitados após o uso do protocolo e complicações perioperatórias. foi observada diferença significativa (p<0,001) no número de exames com resultados alterados entre os dois grupos (14,9% x 29,1%) e redução de 57,3% no número de exames pedidos entre os dois grupos (p<0,001), mais acentuada nos pacientes de menor faixa etária, ASA I, sem doenças associadas e submetidos a procedimentos de menor porte. Não houve diferença significativa na frequência de alterações de conduta motivada por resultado de exames, nem de complicações entre os dois grupos. Na análise multivariada hemograma e coagulograma foram os únicos exames capazes de modificar a conduta anestésico-cirúrgica. o protocolo proposto foi efetivo em eliminar um quantitativo significativo de exames complementares sem indicação clínica, sem que houvesse aumento na morbidade e mortalidades perioperatórias.

  15. 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 (Pimpact factor, reporting sources 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.

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

    Science.gov (United States)

    2012-01-01

    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

  17. 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

  18. 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

  19. 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

  20. The impact of a bodyweight and physical activity intervention (BeWEL) initiated through a national colorectal cancer screening programme: randomised controlled trial.

    Science.gov (United States)

    Anderson, Annie S; Craigie, Angela M; Caswell, Stephen; Treweek, Shaun; Stead, Martine; Macleod, Maureen; Daly, Fergus; Belch, Jill; Rodger, Jackie; Kirk, Alison; Ludbrook, Anne; Rauchhaus, Petra; Norwood, Patricia; Thompson, Joyce; Wardle, Jane; Steele, Robert J C

    2014-03-07

    To evaluate the impact of a diet and physical activity intervention (BeWEL) on weight change in people with a body mass index >25 weight (kg)/height (m)(2) at increased risk of colorectal cancer and other obesity related comorbidities. Multicentre, parallel group, randomised controlled trial. Four Scottish National Health Service health boards. 329 overweight or obese adults (aged 50 to 74 years) who had undergone colonoscopy after a positive faecal occult blood test result, as part of the national bowel screening programme, and had a diagnosis of adenoma confirmed by histopathology. 163 were randomised to intervention and 166 to control. Participants were randomised to a control group (weight loss booklet only) or 12 month intervention group (three face to face visits with a lifestyle counsellor plus monthly 15 minute telephone calls). A goal of 7% reduction in body weight was set and participants received a personalised energy prescription (2508 kJ (600 kcal) below that required for weight maintenance) and bodyweight scales. Motivational interviewing techniques explored self assessed confidence, ambivalence, and personal values concerning weight. Behavioural strategies included goal setting, identifying intentions of implementation, self monitoring of body weight, and counsellor feedback about reported diet, physical activity, and weight change. The primary outcome was weight change over 12 months. Secondary outcomes included changes in waist circumference, blood pressure, fasting cardiovascular biomarkers, and glucose metabolism variables, physical activity, diet, and alcohol consumption. At 12 months, data on the primary outcome were available for 148 (91%) participants in the intervention group and 157 (95%) in the control group. Mean weight loss was 3.50 kg (SD 4.91) (95% confidence interval 2.70 to 4.30) in the intervention group compared with 0.78 kg (SD 3.77) (0.19 to 1.38) in the control group. The group difference was 2.69 kg (95% confidence interval 1

  1. 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'sfamily 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.

  2. 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 (pscommunicating 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. 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

  3. CARIAA Call - Frequently Asked Questions

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

    IDRC CRDI

    2013-03-28

    Mar 28, 2013 ... The call states that CARIAA will also collaborate with the consortia on programmatic functions that support the program as a whole, including communication, outreach and engagement, knowledge management, and monitoring and evaluation. What kind of activities are envisaged? 48). The call states that ...

  4. 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 ...

  5. Linking CALL and SLA: Using the IRIS Database to Locate Research Instruments

    Science.gov (United States)

    Handley, Zöe; Marsden, Emma

    2014-01-01

    To establish an evidence base for future computer-assisted language learning (CALL) design, CALL research needs to move away from CALL versus non-CALL comparisons, and focus on investigating the differential impact of individual coding elements, that is, specific features of a technology which might have an impact on learning (Pederson, 1987).…

  6. 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.

  7. Peer support telephone calls for improving health.

    Science.gov (United States)

    Dale, Jeremy; Caramlau, Isabela O; Lindenmeyer, Antje; Williams, Susan M

    2008-10-08

    Peer support telephone calls have been used for a wide range of health-related concerns. However, little is known about their effects. To assess the effects of peer support telephone calls in terms of physical (e.g. blood pressure), psychological (e.g. depressive symptoms), and behavioural health outcomes (e.g. uptake of mammography) and other outcomes. We searched: The Cochrane Library databases (CENTRAL, DARE, CDSR) (issue 4 2007); MEDLINE (OVID) (January 1966 to December 2007); EMBASE (OVID) (January 1985 to December 2007); CINAHL (Athens) (January 1966 to December 2007), trials registers and reference lists of articles, with no language restrictions. Randomised controlled trials of peer support interventions delivered by telephone call. Two review authors independently extracted data. We present results narratively and in tabular format. Meta-analysis was not possible due to heterogeneity between studies. We included seven studies involving 2492 participants.Peer support telephone calls were associated with an increase in mammography screening, with 49% of women in the intervention group and 34% of women in the control group receiving a mammogram since the start of the intervention (P peer telephone support calls were found to maintain mammography screening uptake for baseline adherent women (P = 0.029).Peer support telephone calls for post myocardial infarction patients were associated at six months with a change in diet in the intervention and usual care groups of 54% and 44% respectively (P = 0.03). In another study for post myocardial infarction patients there were no significant differences between groups for self-efficacy, health status and mental health outcomes.Peer support telephone calls were associated with greater continuation of breastfeeding in mothers at 3 months post partum (P = 0.01).Peer support telephone calls were associated with reduced depressive symptoms in mothers with postnatal depression (Edinburgh Postnatal Depression Scale (EPDS

  8. 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.

  9. Management of optic neuritis and impact of clinical trials: an international survey

    DEFF Research Database (Denmark)

    Biousse, Valérie; Calvetti, Olivier; Drews-Botsch, Carolyn D

    2009-01-01

    countries, steroids were often prescribed to improve visual outcome or to decrease the long-term risk of multiple sclerosis. INTERPRETATION: Although recent clinical trials have changed the management of acute ON around the world, many neurologists and ophthalmologists do not evaluate and treat acute...

  10. Impact of Attention Training on Academic Achievement, Executive Functioning, and Behavior: A Randomized Controlled Trial

    Science.gov (United States)

    Kirk, Hannah; Gray, Kylie; Ellis, Kirsten; Taffe, John; Cornish, Kim

    2017-01-01

    Children with intellectual and developmental disabilities (IDD) experience significant difficulties in attention, learning, executive functions, and behavioral regulation. Emerging evidence suggests that computerized cognitive training may remediate these impairments. In a double blind controlled trial, 76 children with IDD (4-11 years) were…

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

    Science.gov (United States)

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

    2015-01-01

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

  12. Assessing Impact and Bridging Methodological Divides: Randomized Trials in Countries Affected by Conflict

    Science.gov (United States)

    Burde, Dana

    2012-01-01

    Randomized trials have experienced a marked surge in endorsement and popularity in education research in the past decade. This surge reignited paradigm debates and spurred qualitative critics to accuse these experimental designs of eclipsing qualitative research. This article reviews a current iteration of this debate and examines two randomized…

  13. Impact of an online writing aid tool for writing a randomized trial report: the COBWEB (Consort-based WEB tool) randomized controlled trial.

    Science.gov (United States)

    Barnes, Caroline; Boutron, Isabelle; Giraudeau, Bruno; Porcher, Raphael; Altman, Douglas G; Ravaud, Philippe

    2015-09-15

    Incomplete reporting is a frequent waste in research. Our aim was to evaluate the impact of a writing aid tool (WAT) based on the CONSORT statement and its extension for non-pharmacologic treatments on the completeness of reporting of randomized controlled trials (RCTs). We performed a 'split-manuscript' RCT with blinded outcome assessment. Participants were masters and doctoral students in public health. They were asked to write, over a 4-hour period, the methods section of a manuscript based on a real RCT protocol, with a different protocol provided to each participant. Methods sections were divided into six different domains: 'trial design', 'randomization', 'blinding', 'participants', 'interventions', and 'outcomes'. Participants had to draft all six domains with access to the WAT for a random three of six domains. The random sequence was computer-generated and concealed. For each domain, the WAT comprised reminders of the corresponding CONSORT item(s), bullet points detailing all the key elements to be reported, and examples of good reporting. The control intervention consisted of no reminders. The primary outcome was the mean global score for completeness of reporting (scale 0-10) for all domains written with or without the WAT. Forty-one participants wrote 41 different manuscripts of RCT methods sections, corresponding to 246 domains (six for each of the 41 protocols). All domains were analyzed. For the primary outcome, the mean (SD) global score for completeness of reporting was higher with than without use of the WAT: 7.1 (1.2) versus 5.0 (1.6), with a mean (95 % CI) difference 2.1 (1.5-2.7; P <0.01). Completeness of reporting was significantly higher with the WAT for all domains except for blinding and outcomes. Use of the WAT could improve the completeness of manuscripts reporting the results of RCTs. Clinicaltrials.gov ( http://clinicaltrials.gov NCT02127567 , registration date first received April 29, 2014).

  14. Impact of Nursing Home Palliative Care Teams on End-of-Life Outcomes: A Randomized Controlled Trial.

    Science.gov (United States)

    Temkin-Greener, Helena; Mukamel, Dana B; Ladd, Heather; Ladwig, Susan; Caprio, Thomas V; Norton, Sally A; Quill, Timothy E; Olsan, Tobie H; Cai, Xueya

    2018-01-01

    Deficits in end-of-life care in nursing homes (NHs) are reported, but the impact of palliative care teams (PCTeams) on resident outcomes remains largely untested. Test the impact of PCTeams on end-of-life outcomes. Multicomponent strategy employing a randomized, 2-arm controlled trial with a difference-in-difference analysis, and a nonrandomized second control group to assess the intervention's placebo effect. In all, 25 New York State NHs completed the trial (5830 decedent residents) and 609 NHs were in the nonrandomized group (119,486 decedents). Four risk-adjusted outcome measures: place of death, number of hospitalizations, self-reported moderate-to-severe pain, and depressive symptoms. The Minimum Data Set, vital status files, staff surveys, and in-depth interviews were employed. For each outcome, a difference-in-difference model compared the pre-post intervention periods using logistic and Poisson regressions. Overall, we found no statistically significant effect of the intervention. However, independent analysis of the interview data found that only 6 of the 14 treatment facilities had continuously working PCTeams throughout the study period. Decedents in homes with working teams had significant reductions in the odds of in-hospital death compared to the other treatment [odds ratio (OR), 0.400; Phomes vary in their ability to adopt new care practices, and in their capacity to sustain them, reforms to create the environment in which effective palliative care can become broadly implemented are needed.

  15. 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.

  16. Impact of body habitus on single-site laparoscopic appendectomy for nonperforated appendicitis: subset analysis from a prospective, randomized trial.

    Science.gov (United States)

    Knott, E Marty; Gasior, Alessandra C; Holcomb, George W; Ostlie, Daniel J; St Peter, Shawn D

    2012-05-01

    There have been several series documenting the utility of single-site laparoscopic appendectomy. However, there are no data to support patient selection based on their physical characteristics. We recently completed a large prospective, randomized trial comparing single-site laparoscopic appendectomy with standard three-port laparoscopic appendectomy for nonperforated appendicitis. This dataset was used to examine the relative impact of body habitus on operative approach. We performed an analysis of the dataset collected in a prospective, randomized trial of 360 appendectomy patients who presented with nonperforated appendicitis. Body mass index (BMI) was calculated and plotted on a growth chart to obtain BMI percentile according to gender and age. Standard definitions for overweight (BMI 85-95%) and obesity (BMI >95%) were used. In the single-site group there were 26 overweight and 19 obese patients. In the three-port group there were 25 overweight and 16 obese patients. There were no significant differences between overweight and normal with either approach. However, with the single-site approach there was longer mean operative time, more doses of postoperative narcotics given, longer length of stay, and greater hospital charges in obese patients. In the three-port group, there were no differences between normal and obese patients. When using the single-site approach for appendectomy, obesity in children creates longer operative times, more doses of postoperative analgesics, longer length of stay, and greater charges. However, obesity has no impact on three-port appendectomy.

  17. 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 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...

  18. The impact of physical activity on fatigue and quality of life in lung cancer patients: a randomised controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Dhillon Haryana M

    2012-12-01

    Full Text Available Abstract Background People with lung cancer have substantial symptom burden and more unmet needs than the general cancer population. Physical activity (PA has been shown to positively influence quality of life (QOL, fatigue and daily functioning in the curative treatment of people with breast and colorectal cancers and lung diseases, as well as in palliative settings. A randomised controlled trial (RCT is needed to determine if lung cancer patients benefit from structured PA intervention. The Physical Activity in Lung Cancer (PAL trial is designed to evaluate the impact of a 2-month PA intervention on fatigue and QOL in patients with non-resectable lung cancer. Biological mechanisms will also be studied. Methods/design A multi-centre RCT with patients randomised to usual care or a 2-month PA programme, involving supervised PA sessions including a behavioural change component and home-based PA. QOL questionnaires, disease and functional status and body composition will be assessed at baseline, 2, 4 and 6 months follow-up. The primary endpoint is comparative levels of fatigue between the 2 arms. Secondary endpoints include: QOL, functional abilities and physical function. Exploratory endpoints include: anxiety, depression, distress, dyspnoea, PA behaviour, fitness, hospitalisations, survival, cytokines and insulin-like growth factor levels. Discussion This study will provide high-level evidence of the effect of PA programmes on cancer-related fatigue and QOL in patients with advanced lung cancer. If positive, the study has the potential to change care for people with cancer using a simple, inexpensive intervention to improve their QOL and help them maintain independent function for as long as possible. Trial registration Australian New Zealand Clinical Trials Registry No. ACTRN12609000971235

  19. 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 χ2 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 (ppurchasing from other stores into study supermarkets 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 ).

  20. Impact of text and email messaging on the sexual health of young people: a randomised controlled trial.

    Science.gov (United States)

    Lim, Megan S C; Hocking, Jane S; Aitken, Campbell K; Fairley, Christopher K; Jordan, Lynne; Lewis, Jennifer A; Hellard, Margaret E

    2012-01-01

    To carry out a randomised controlled trial on the effect of a new method of health promotion-email and mobile phone text messages (short messaging service (SMS))-on young people's sexual health. 994 people aged 16-29 were recruited at a music festival to a non-blinded randomised controlled trial. Participants were randomised to either receive sexual health promotion messages (n=507) or the control group (n=487). The 12-month intervention included SMS (catchy sexually transmissible infections prevention slogans) and emails. Participants completed questionnaires at the festival at baseline and online after 3, 6 and 12 months. Outcomes were differences between the control and intervention groups in health-seeking behaviour, condom use with risky partners (new or casual partners or two or more partners within 12 months) and STI knowledge. 337 (34%) completed all three follow-up questionnaires and 387 (39%) completed the final questionnaire. At 12 months, STI knowledge was higher in the intervention group for both male (OR=3.19 95% CI 1.52 to 6.69) and female subjects (OR=2.36 95% CI 1.27 to 4.37). Women (but not men) in the intervention group were more likely to have had an STI test (OR=2.51, 95% CI 1.11 to 5.69), or discuss sexual health with a clinician (OR=2.92, 95% CI 1.66 to 5.15) than their control counterparts. There was no significant impact on condom use. Opinions of the messages were favourable. This simple intervention improved STI knowledge in both sexes and STI testing in women, but had no impact on condom use. SMS and email are low cost, popular and convenient, and have considerable potential for health promotion. Australian Clinical Trials Registry - ACTRN12605000760673.

  1. 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.

  2. Evaluating Research and Impact: A Bibliometric Analysis of Research by the NIH/NIAID HIV/AIDS Clinical Trials Networks

    Science.gov (United States)

    Rosas, Scott R.; Kagan, Jonathan M.; Schouten, Jeffrey T.; Slack, Perry A.; Trochim, William M. K.

    2011-01-01

    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. PMID:21394198

  3. Economic evaluation of the differential benefits of home visits with telephone calls and telephone calls only in transitional discharge support.

    Science.gov (United States)

    Wong, Frances Kam Yuet; So, Ching; Chau, June; Law, Antony Kwan Pui; Tam, Stanley Ku Fu; McGhee, Sarah

    2015-01-01

    home visits and telephone calls are two often used approaches in transitional care, but their differential economic effects are unknown. to examine the differential economic benefits of home visits with telephone calls and telephone calls only in transitional discharge support. cost-effectiveness analysis conducted alongside a randomised controlled trial (RCT). patients discharged from medical units randomly assigned to control (control, N = 210), home visits with calls (home, N = 196) and calls only (call, N = 204). cost-effectiveness analyses were conducted from the societal perspective comparing monetary benefits and quality-adjusted life years (QALYs) gained. the home arm was less costly but less effective at 28 days and was dominating (less costly and more effective) at 84 days. The call arm was dominating at both 28 and 84 days. The incremental QALY for the home arm was -0.0002/0.0008 (28/84 days), and the call arm was 0.0022/0.0104 (28/84 days). When the three groups were compared, the call arm had a higher probability being cost-effective at 84 days but not at 28 days (home: 53%, call: 35% (28 days) versus home: 22%, call: 73% (84 days)) measuring against the NICE threshold of £20,000. the original RCT showed that the bundled intervention involving home visits and calls was more effective than calls only in the reduction of hospital readmissions. This study adds a cost perspective to inform policymakers that both home visits and calls only are cost-effective for transitional care support, but calls only have a higher chance of being cost-effective for a sustained period after intervention. © The Author 2014. Published by Oxford University Press on behalf of the British Geriatrics Society.

  4. A randomized controlled trial evaluating the impact of knowledge translation and exchange strategies

    Directory of Open Access Journals (Sweden)

    O'Mara Linda

    2009-09-01

    Full Text Available Abstract Context Significant resources and time are invested in the production of research knowledge. The primary objective of this randomized controlled trial was to evaluate the effectiveness of three knowledge translation and exchange strategies in the incorporation of research evidence into public health policies and programs. Methods This trial was conducted with a national sample of public health departments in Canada from 2004 to 2006. The three interventions, implemented over one year in 2005, included access to an online registry of research evidence; tailored messaging; and a knowledge broker. The primary outcome assessed the extent to which research evidence was used in a recent program decision, and the secondary outcome measured the change in the sum of evidence-informed healthy body weight promotion policies or programs being delivered at health departments. Mixed-effects models were used to test the hypotheses. Findings One hundred and eight of 141 (77% health departments participated in this study. No significant effect of the intervention was observed for primary outcome (p e.g., value placed on research evidence in decision making. Conclusion The results of this study suggest that under certain conditions tailored, targeted messages are more effective than knowledge brokering and access to an online registry of research evidence. Greater emphasis on the identification of organizational factors is needed in order to implement strategies that best meet the needs of individual organizations. Trial Registration The trial registration number and title are as follows: ISRCTN35240937 -- Is a knowledge broker more effective than other strategies in promoting evidence-based physical activity and healthy body weight programming?

  5. Does mass azithromycin distribution impact child growth and nutrition in Niger? A cluster-randomized trial.

    Directory of Open Access Journals (Sweden)

    Abdou Amza

    2014-09-01

    Full Text Available Antibiotic use on animals demonstrates improved growth regardless of whether or not there is clinical evidence of infectious disease. Antibiotics used for trachoma control may play an unintended benefit of improving child growth.In this sub-study of a larger randomized controlled trial, we assess anthropometry of pre-school children in a community-randomized trial of mass oral azithromycin distributions for trachoma in Niger. We measured height, weight, and mid-upper arm circumference (MUAC in 12 communities randomized to receive annual mass azithromycin treatment of everyone versus 12 communities randomized to receive biannual mass azithromycin treatments for children, 3 years after the initial mass treatment. We collected measurements in 1,034 children aged 6-60 months of age.We found no difference in the prevalence of wasting among children in the 12 annually treated communities that received three mass azithromycin distributions compared to the 12 biannually treated communities that received six mass azithromycin distributions (odds ratio = 0.88, 95% confidence interval = 0.53 to 1.49.We were unable to demonstrate a statistically significant difference in stunting, underweight, and low MUAC of pre-school children in communities randomized to annual mass azithromycin treatment or biannual mass azithromycin treatment. The role of antibiotics on child growth and nutrition remains unclear, but larger studies and longitudinal trials may help determine any association.

  6. 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)

    2015-10-01

    AWARD NUMBER: W81XWH-13-1-0479 TITLE: Sleep -Disordered Breathing in Chronic SCI: A Randomized Controlled Trial of Treatment Impact on...October 2015 2. REPORT TYPE Annual Report 3. DATES COVERED 30 Sep 2014 - 29 Sep 2015 4. TITLE AND SUBTITLE 5a. CONTRACT NUMBER Sleep -Disordered...randomized controlled trial, we will objectively measure sleep disordered breathing (SDB) in chronic SCI patients using portable sleep studies, and

  7. 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.

  8. 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.

  9. Evolution of advertisement calls in African clawed frogs.

    Science.gov (United States)

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

    2011-01-01

    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.

  10. 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

  11. Quantifying uncertainty in genotype calls.

    Science.gov (United States)

    Carvalho, Benilton S; Louis, Thomas A; Irizarry, Rafael A

    2010-01-15

    Genome-wide association studies (GWAS) are used to discover genes underlying complex, heritable disorders for which less powerful study designs have failed in the past. The number of GWAS has skyrocketed recently with findings reported in top journals and the mainstream media. Microarrays are the genotype calling technology of choice in GWAS as they permit exploration of more than a million single nucleotide polymorphisms (SNPs) simultaneously. The starting point for the statistical analyses used by GWAS to determine association between loci and disease is making genotype calls (AA, AB or BB). However, the raw data, microarray probe intensities, are heavily processed before arriving at these calls. Various sophisticated statistical procedures have been proposed for transforming raw data into genotype calls. We find that variability in microarray output quality across different SNPs, different arrays and different sample batches have substantial influence on the accuracy of genotype calls made by existing algorithms. Failure to account for these sources of variability can adversely affect the quality of findings reported by the GWAS. We developed a method based on an enhanced version of the multi-level model used by CRLMM version 1. Two key differences are that we now account for variability across batches and improve the call-specific assessment of each call. The new model permits the development of quality metrics for SNPs, samples and batches of samples. Using three independent datasets, we demonstrate that the CRLMM version 2 outperforms CRLMM version 1 and the algorithm provided by Affymetrix, Birdseed. The main advantage of the new approach is that it enables the identification of low-quality SNPs, samples and batches. Software implementing of the method described in this article is available as free and open source code in the crlmm R/BioConductor package. Supplementary data are available at Bioinformatics online.

  12. Impact of the Alexander technique on well-being: a randomised controlled trial involving older adults with visual impairment.

    Science.gov (United States)

    Gleeson, Michael; Sherrington, Catherine; Lo, Serigne; Auld, Robin; Keay, Lisa

    2017-11-01

    Older adults with visual loss have high rates of depression, restricted participation and reduced quality of life. We sought to measure the impact of lessons in the Alexander technique on vision-related emotional and social well-being, as secondary outcomes to a study on improving physical functioning in this population. This is a single-blind randomised controlled trial. One hundred and twenty community-dwelling adults aged 50 to 90 years with visual impairments were randomised to either 12 Alexander lessons over 12 weeks and usual care or usual care. The Perceived Visual Ability Scale, the Keele Assessment of Participation, the emotional subscale of the Impact of Vision Impairment Profile, the Positive and Negative Affect Scale and the five-item Geriatric Depression Scale were administered at baseline and three and 12 months. Participants were receiving services from Guide Dogs NSW/ACT. None of the validated questionnaires found statistically significant improvements after adjustment for baseline at three or 12 months, although the emotional subscale of the Impact of Vision Impairment approached significance in favour of the intervention group (4.54 points, 95 per cent CI: -0.14 to 9.21, p = 0.06). Depressive symptoms were prevalent and associated with greater impact of visual impairment on emotional well-being (odds ratio: 1.12, 95 per cent CI: 1.07 to 1.17, p Alexander technique on social and emotional well-being, although the emotional impact of visual impairment showed a trend toward less distress in the intervention group. Our data found that emotional distress associated with visual impairment influences depressive symptoms but contrary to expectations, the level of social support received was not significant. Additionally, gait speed is a significant predictor of depressive symptoms, suggesting that general mobility is of importance to the well-being of older adults with visual impairments. © 2017 Optometry Australia.

  13. Impact of baseline physical activity and diet behavior on metabolic syndrome in a pharmaceutical trial: results from NAVIGATOR.

    Science.gov (United States)

    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

    2014-04-01

    The cardiometabolic risk cluster metabolic syndrome (MS) includes ≥3 of 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. 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. For every 2000-step increase in average daily steps, there was an associated reduction in average MSSc of 0.29 (95% CI (-)0.33 to (-)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. Baseline physical activity and diet behavior were associated independently with reductions in MSSc such that increased attention to these lifestyle elements provides cardiometabolic benefits. Thus, given the potential to

  14. 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

  15. The impact of vitamin D on infectious disease: a systematic review of controlled trials

    Science.gov (United States)

    Kearns, Malcolm D.; Alvarez, Jessica A.; Seidel, Natan; Tangpricha, Vin

    2014-01-01

    Background Observational studies have linked vitamin D status and infectious disease. This association is supported by the presence of the vitamin D receptor and CYP27B1 in immune cells. This review aims to consolidate data from clinical trials that used vitamin D for the treatment or prevention of infectious disease. Methods We searched the term “(vitamin D OR ergocalciferol OR cholecalciferol OR vitamin D2 OR vitamin D3 OR calcitriol) AND (infection OR tuberculosis OR sepsis OR pneumonia)” with limits preset to manuscripts published in English and with human subjects. We identified controlled trials that measured infectious outcomes (e.g. incidence and severity of disease, time to disease resolution or recurrence, measures of clinical improvement, mortality). Studies were excluded that: used analog, topical, or micronutrient formulations of vitamin D, assessed only vitamin D status, or lacked a comparison group. The references from eligible manuscripts and from 2 recent reviews were scanned for additional manuscripts. Results 1284 manuscripts were identified with our search terms, with 60 papers still eligible after review of the title and abstract. Full review of these papers, their references and 2 related reviews yielded 38 manuscripts. Conclusion Though some prospective studies show positive results regarding vitamin D on infectious disease, several robust studies are negative. Factors such as high variability between studies, the difference in individual responsiveness to vitamin D, and study designs that do not primarily investigate infectious outcomes may mask the effects of vitamin D on infections. PMID:25334038

  16. Revisiting a longstanding clinical trial exclusion criterion: impact of prior cancer in early-stage lung cancer.

    Science.gov (United States)

    Pruitt, Sandi L; Laccetti, Andrew L; Xuan, Lei; Halm, Ethan A; Gerber, David E

    2017-03-14

    Early-stage lung cancer represents a key focus of numerous multicenter clinical trials, but common exclusion criteria such as a prior cancer diagnosis may limit enrollment. We examined the prevalence and prognostic impact of a prior cancer diagnosis among patients with early-stage lung cancer. We identified patients>65 years of age with early-stage lung cancer diagnosed 1996-2009 in the Surveillance, Epidemiology, and End Results-Medicare linked database. Prior cancers were characterized by type, stage, and timing with respect to the lung cancer diagnosis. All-cause and lung cancer specific-survival rates were compared between patients with and without prior cancer using Cox regression analyses and propensity scores. Among 42,910 patients with early-stage lung cancer, one-fifth (21%) had a prior cancer. The most common prior cancers were prostate (21%), breast (18%), gastrointestinal (17%), and other genitourinary (15%). Most prior cancers were localized, and 61% were diagnosed within 5 years of the lung cancer diagnosis. There was no difference in all-cause survival between patients with and without prior cancer (hazard ratio [HR] 1.01; P=0.52). Lung cancer specific survival was improved among patients with prior cancer (HR 0.79; Pcancer history may exclude a substantial proportion of patients with early-stage lung cancer from enrollment in clinical trials. Without adverse effect on clinical outcomes, inclusion of patients age >65 years with prior cancer in clinical trials should be considered to improve study accrual, completion rates, and generalizability.

  17. 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.

  18. Gastric and intestinal barrier impairment in tropical enteropathy and HIV: limited impact of micronutrient supplementation during a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Smith Geoff

    2010-07-01

    Full Text Available Abstract Background Although micronutrient supplementation can reduce morbidity and mortality due to diarrhoea, nutritional influences on intestinal host defence are poorly understood. We tested the hypothesis that micronutrient supplementation can enhance barrier function of the gut. Methods We carried out two sub-studies nested within a randomised, double-blind placebo-controlled trial of daily micronutrient supplementation in an urban community in Lusaka, Zambia. In the first sub-study, gastric pH was measured in 203 participants. In the second sub-study, mucosal permeability, lipopolysaccharide (LPS and anti-LPS antibodies, and serum soluble tumour necrosis factor receptor p55 (sTNFR55 concentrations were measured in 87 participants. Up to three stool samples were also analysed microbiologically for detection of asymptomatic intestinal infection. Gastric histology was subsequently analysed in a third subset (n = 37 to assist in interpretation of the pH data. Informed consent was obtained from all participants after a three-stage information and consent process. Results Hypochlorhydria (fasting gastric pH > 4.0 was present in 75 (37% of participants. In multivariate analysis, HIV infection (OR 4.1; 95%CI 2.2-7.8; P P = 0.01 and allocation to micronutrient supplementation (OR 0.53; 0.28-0.99; P Helicobacter pylori or HIV status. Intestinal permeability, LPS concentrations in serum, anti-LPS IgG, and sTNFR55 concentrations did not differ significantly between micronutrient and placebo groups. Anti-LPS IgM was reduced in the micronutrient recipients (P 0.05. Conclusions We found evidence of a specific effect of HIV on gastric pH which was readily reversed by anti-retroviral therapy and not mediated by gastric atrophy. Micronutrients had a modest impact on gastric pH and one marker of bacterial translocation. Trial Registration Current Controlled Trials ISRCTN31173864

  19. 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.

  20. 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...

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

    OpenAIRE

    Subaiya, S; Hogg, E; Roberts, I

    2011-01-01

    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 ca...

  2. The impact of a family skills training intervention among Burmese migrant families in Thailand: A randomized controlled trial

    Science.gov (United States)

    2017-01-01

    Objective To conduct a randomized controlled trial assessing the impact of a family-based intervention delivered to Burmese migrant families displaced in Thailand on parenting and family functioning. Participants and procedures Participants included 479 Burmese migrant families from 20 communities in Thailand. Families, including 513 caregivers and 479 children aged 7 to 15 years, were randomized to treatment and waitlist control groups. The treatment group received a 12-session family-based intervention delivered to groups of families by lay facilitators. Adapted standardized and locally derived measures were administered before and after the intervention to assess parent-child relationship quality, discipline practices, and family functioning. Results Compared with controls, intervention families demonstrated improved quality of parent-child interactions on scales of parental warmth and affection (Effect size (ES) = 0.25 caregivers; 0.26 children, both p discipline (ES = -0.39, p discipline strategies. Treatment attendance was high, with participants attending a mean of 9.7 out of 12 sessions. Conclusion The intervention increased protective aspects of family well-being for migrant children and caregivers in a middle-income country. The strongest effects were on parent-child relationship quality and family functioning, while results were mixed on changes in discipline practices. Results suggest that a behavioral family-based approach implemented by lay providers in community settings is a promising intervention approach for strengthening families in highly stressed contexts. Trial registration Clinicaltrials.gov: NCT01668992 PMID:28350809

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

    Energy Technology Data Exchange (ETDEWEB)

    Greenberg, B.M.; Gurska, J.; Huang, X.D.; Gerhardt, K.E.; Yu, X.M.; Nykamp, J.; MacNeill, G.; Yang, S.; Lu, X.; Glick, B. [Waterloo Univ., ON (Canada). Dept. of Biology]|[Waterloo Environmental Biotechnology Inc., Hamilton, ON (Canada); Wang, W.; Knezevich, N. [Waterloo Univ., ON (Canada). Dept. of Biology; Gerwing, P.; Cryer, K. [Earthmaster Environmental Strategies Inc., Calgary, AB (Canada); Reid, N. [EBA Engineering Consultants Ltd., Edmonton, AB (Canada)

    2008-07-01

    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.

  4. 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.

  5. 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 < .05). We even verified that the poorer the defendant, the higher was the corresponding conviction rate (Wald's Test = 5.90, p < .05). The results are discussed based on theories of social psychology and criminological sociology, which consider the relationship between skin color and socioeconomic status in social judgments and in discrimination.

  6. Assessing the impact of a new delivery method of insulin on glycemic control using a novel trial design

    Directory of Open Access Journals (Sweden)

    Thomas Strack

    2009-01-01

    Full Text Available Thomas Strack1, Luc Martinez2, Stefano Del Prato3, Larry Blonde4, Burkhard Göke5, Vincent Woo6, Ann Millward7, Ramon Gomis8, Bill Canovatchel1, David Lawrence1, Nick Freemantle9 on behalf of the EXPERIENCE Trial Team1Pfizer Inc., New York, NY, USA; 2Société Française de Médecine Générale, Issy les Moulineaux, France; 3University of Pisa, Pisa, Italy; 4Ochsner Medical Center, New Orleans, LO, USA; 5University of Munich, Munich, Germany; 6Health Sciences Centre, Winnipeg, Canada; 7Peninsula Medical School, Plymouth, UK; 8University of Barcelona, Barcelona, Spain; 9University of Birmingham, Birmingham, UKObjective: The purpose of the trial was to examine the impact of inhaled human insulin (INH on patient or physician willingness to adopt insulin after oral diabetes agent failure.Research design and methods: The EXPERIENCE trial was a one-year randomized controlled trial conducted at primary, secondary and tertiary care facilities in Europe and North America. The primary study endpoint was difference in glycated hemoglobin (A1c between randomized groups at 26 weeks, and results from that phase have been reported previously. The present report concerns results from the second 26-week extension phase. We also consider the applicability of the design. The trial recruited 727 patients with type 2 diabetes mellitus who, prior to randomization, were using two or more oral diabetes agents and whose A1c was ≥8.0%. Patients were randomized to two treatment settings: Group 1 (usual care with the option of INH or Group 2 (usual care only. Usual care included adjusting oral therapy (optimizing current regimen or adding/deleting agents and/or initiating subcutaneous (SC insulin.Results: At baseline, insulin was initiated by more (odds ratio [OR] 6.0;95% confidence interval [CI] 4.2 to 8.8; P < 0.0001 patients in Group 1 (86.2%; 76.7% INH plus 9.5% SC than in Group 2 (50.7%; SC insulin only. The largest reduction from baseline in A1c was in Group 1 (

  7. Measuring the impact of non-monetary incentives on facility delivery in rural Zambia: a clustered randomised controlled trial.

    Science.gov (United States)

    Wang, P; Connor, A L; Guo, E; Nambao, M; Chanda-Kapata, P; Lambo, N; Phiri, C

    2016-04-01

    In Zambia, only 56% of rural women deliver in a health facility, and improving facility delivery rates is a priority of the Zambian government. 'Mama kit' incentives - small packages of childcare items provided to mothers conditional on delivering their baby in a facility - may encourage facility delivery. This study measured the impact and cost-effectiveness of a US$4 mama kit on rural facility delivery rates in Zambia. A clustered randomised controlled trial was used to measure the impact of mama kits on facility delivery rates in thirty rural health facilities in Serenje and Chadiza districts. Facility-level antenatal care and delivery registers were used to measure the percentage of women attending antenatal care who delivered at a study facility during the intervention period. Results from the trial were then used to model the cost-effectiveness of mama kits at-scale in terms of cost per death averted. The mama kits intervention resulted in a statistically significant increase in facility delivery rates. The multivariate logistic regression found that the mama kits intervention increased the odds of delivering at a facility by 63% (P-value < 0.01, 95% CI: 29%, 106%), or an increase of 9.9 percentage points, yielding a cost-effectiveness of US$5183 per death averted. This evaluation confirms that low-cost mama kits can be a cost-effective intervention to increase facility delivery rates in rural Zambia. Mama kits alone are unlikely to completely solve safe delivery challenges but should be embedded in larger maternal and child health programmes. © 2016 John Wiley & Sons Ltd.

  8. The impact of telemonitoring upon hospice referral in the community: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Takahashi PY

    2012-11-01

    Full Text Available Paul Y Takahashi,1 Gregory J Hanson,1,2 Bjorg Thorsteinsdottir,1 Holly K Van Houten,3 Nilay D Shah,3 James M Naessens,3 Jennifer L Pecina41Division of Primary Care Internal Medicine, 2Kogod Center of Aging, 3Division of Health Science Research, 4Department of Family Medicine, Mayo Clinic, Rochester, MN, USABackground: Using telemedicine for older adults with multiple comorbid conditions is a potential area for growth in health care. Given this older, ailing population, providers should discuss end-of-life care with patients.Objective: To determine the relationship between telemonitoring and hospice enrollment compared to usual care among older adults with chronic health problems.Methods: This was a secondary evaluation of a randomized controlled trial. The trial was performed at an academic medical center. Patients who were over the age of 60 and had a high risk of hospitalization and emergency department visits were recruited to the study. The primary outcome was hospice enrollment, and the secondary outcome was the mean number of days in hospice. The data were analyzed using Chi-squared tests and time-to-event analysis.Results: The average age of the cohort was 80.3 years. Nine patients (9.6% in the telemonitoring group were enrolled in hospice care, whereas four patients (4.0% in the usual care group were enrolled (P = 0.12. The mean number of days in hospice was 57.9 (SD ± 99.2 for the telemonitoring group, and 119.3 (SD ± 123.8 for the usual care group (P = 0.36. There was no significant difference regarding time to hospice referral.Conclusion: In this pilot analysis, there were no differences noted between groups in the number of patients that entered into hospice or the amount of time they stayed in hospice care. This was a small trial, and the power to detect a difference was 36%. It was encouraging that twice the number of patients enrolled in hospice care in the telemonitoring group compared to usual care despite the insignificant

  9. Trial by Dutch Laboratories for Evaluation of Non-Invasive Prenatal Testing. Part I - Clinical Impact

    NARCIS (Netherlands)

    Oepkes, Dick; Page-Christiaens, Lieve C; Bax, Caroline J; Bekker, Mireille N; Bilardo, Catia M; Boon, Elles M J; Schuring-Blom, G Heleen; Coumans, Audrey B C; Faas, Brigitte H; Galjaard, Robert-Jan H; Go, Attie T; Henneman, Lidewij; Macville, Merryn V E; Pajkrt, Eva; Suijkerbuijk, Ron F; Huijsdens-vanAmsterdam, Karin; Van Opstal, Diane; Verweij, E J Joanne; Weiss, Marjan M; Sistermans, Erik A

    2016-01-01

    OBJECTIVE: To evaluate the clinical impact of nationwide implementation of genome-wide Non-Invasive Prenatal Testing (NIPT) in pregnancies at increased risk for fetal trisomies 21, 18 and 13. METHOD: Women with elevated risk based on first trimester combined testing (FCT ≥ 1:200) or medical history,

  10. CALL and the Speaking Skill.

    Science.gov (United States)

    James, Robert

    1996-01-01

    Using common technologies listed in the conversation class, the article suggests a computer-aided language learning (CALL) speaking methodology that is interaction rather than machine centered and outlines ways to ensure the success of speaking activities at the computer. (31 references) (Author/CK)

  11. 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.

  12. An Evaluation Framework for CALL

    Science.gov (United States)

    McMurry, Benjamin L.; Williams, David Dwayne; Rich, Peter J.; Hartshorn, K. James

    2016-01-01

    Searching prestigious Computer-assisted Language Learning (CALL) journals for references to key publications and authors in the field of evaluation yields a short list. The "American Journal of Evaluation"--the flagship journal of the American Evaluation Association--is only cited once in both the "CALICO Journal and Language…

  13. INTESTINAL ANTIMICROBIAL GENE EXPRESSION: IMPACT OF MICRONUTRIENTS IN MALNOURISHED ADULTS DURING A RANDOMISED TRIAL

    Science.gov (United States)

    Dhaliwal, Winnie; Shawa, Tamara; Khanam, Moriam; Jagatiya, Poonam; Simuyandi, Michelo; Ndulo, Namwiinga; Bevins, Charles L; Sanderson, Ian R; Kelly, Paul

    2012-01-01

    Background As both micronutrients and antimicrobial peptides protect against diarrhoea, we looked for an effect on intestinal antimicrobial peptide gene expression during a randomised controlled trial of multiple micronutrient (MM) supplementation. Methods Consenting adults (n=287) in Lusaka, Zambia were randomised to a daily MM supplement or placebo, and followed for 3.3 years with a cross-over after 2 years. Intestinal biopsies were taken at annual intervals and mRNA of the intestinal antimicrobial peptides HD5, HD6, hBD1, hBD2 and LL-37 were quantified by real time RT-PCR. Samples were also taken during diarrhoea episodes and after convalescence. Results There was no effect overall of treatment allocation. However in malnourished adults (body mass index Micronutrient supplementation was associated with up-regulation of HD5 only in malnourished adults. Interactions between antimicrobial gene expression and nutritional status may help explain increased infection risk in malnutrition. PMID:20695797

  14. 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

  15. 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

  16. Impact of quality circles for improvement of asthma care: results of a randomized controlled trial.

    Science.gov (United States)

    Schneider, Antonius; Wensing, Michel; Biessecker, Kathrin; Quinzler, Renate; Kaufmann-Kolle, Petra; Szecsenyi, Joachim

    2008-04-01

    Quality circles (QCs) are well established as a means of aiding doctors. New quality improvement strategies include benchmarking activities. The aim of this paper was to evaluate the efficacy of QCs for asthma care working either with general feedback or with an open benchmark. Twelve QCs, involving 96 general practitioners, were organized in a randomized controlled trial. Six worked with traditional anonymous feedback and six with an open benchmark; both had guided discussion from a trained moderator. Forty-three primary care practices agreed to give out questionnaires to patients to evaluate the efficacy of QCs. A total of 256 patients participated in the survey, of whom 185 (72.3%) responded to the follow-up 1 year later. Use of inhaled steroids at baseline was high (69%) and self-management low (asthma education 27%, individual emergency plan 8%, and peak flow meter at home 21%). Guideline adherence in drug treatment increased (P = 0.19), and asthma steps improved (P = 0.02). Delivery of individual emergency plans increased (P = 0.008), and unscheduled emergency visits decreased (P = 0.064). There was no change in asthma education and peak flow meter usage. High medication guideline adherence was associated with reduced emergency visits (OR 0.24; 95% CI 0.07-0.89). Use of theophylline was associated with hospitalization (OR 7.1; 95% CI 1.5-34.3) and emergency visits (OR 4.9; 95% CI 1.6-14.7). There was no difference between traditional and benchmarking QCs. Quality circles working with individualized feedback are effective at improving asthma care. The trial may have been underpowered to detect specific benchmarking effects. Further research is necessary to evaluate strategies for improving the self-management of asthma patients.

  17. Impact of a school-based intervention to promote fruit intake: a cluster randomized controlled trial.

    Science.gov (United States)

    Rosário, R; Araújo, A; Padrão, P; Lopes, O; Moreira, A; Abreu, S; Vale, S; Pereira, B; Moreira, P

    2016-07-01

    There is evidence that fruit consumption among school children is below the recommended levels. This study aims to examine the effects of a dietary education intervention program me, held by teachers previously trained in nutrition, on the consumption of fruit as a dessert at lunch and dinner, among children 6-12 years old. This is a randomized trial with the schools as the unit of randomisation. A total of 464 children (239 female, 6-12years) from seven elementary schools participated in this cluster randomized controlled trial. Three schools were allocated to the intervention and four to the control group. For the intervention schools, we delivered professional development training to school teachers (12 sessions of 3 h each). The training provided information about nutrition, healthy eating, the importance of drinking water and healthy cooking activities. After each session, teachers were encouraged to develop classroom activities focused on the learned topics. Sociodemographic was assessed at baseline and anthropometric, dietary intake and physical activity assessments were performed at baseline and at the end of the intervention. Dietary intake was evaluated by a 24-h dietary recall and fruit consumption as a dessert was gathered at lunch and dinner. Intervened children reported a significant higher intake in the consumption of fruit compared to the controlled children at lunch (P = 0.001) and at dinner (P = 0.012), after adjusting for confounders. Our study provides further support for the success of intervention programmes aimed at improving the consumption of fruit as a dessert in children. Copyright © 2016 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

  18. Randomized clinical trial on the use of antispasmodic drugs in barium enema: impact on radiological practice

    Energy Technology Data Exchange (ETDEWEB)

    Goei, Reginald; Kessels, Alphons H.; Nix, Maarten; Knipschild, Paul G

    2000-10-01

    Purpose: To assess the willingness of radiologists to change their practice when the results of a randomized clinical trial (RCT) on the use of antispasmodic drugs in barium enema are presented. Materials and Methods: During the years 1994 and 1995 two postal questionnaires were sent to 481 practicing radiologists who were all members of the Netherlands Society of Radiology. In the first questionnaire the respondents were asked to give the characteristics of their practices in performing daily barium enema. The data from this questionnaire was used as a reference. The second questionnaire was sent to the respondents together with an abstract on the randomized clinical trial supporting the use of antispasmodic drugs in barium enema. We also indicated a preference for Buscopan over Glucagon as the antispasmodic drug. The willingness to change prescription habits was measured by comparing the data of the two questionnaires. Results: Of 481 practicing radiologists, 312 responded to the first questionnaire and gave information of their prescription habits (response rate 64%). These 312 responders were sent an abstract of the RCT and were asked to fill out a second questionnaire to determine their willingness to change their practice. Two hundred and sixty-seven radiologists responded (response rate 86%). A significant number of 119 (51%) were willing to increase the use of antispasmodic drugs. A significant number of 128 (55%) chose to increase the use of Buscopan, while a significant number of 81 (32%) were willing to decrease the use of Glucagon. Conclusion: Direct exposure to the results of an RCT recommending the use of antispasmodic drugs in barium enema, especially Buscopan, is likely to increase its use by practicing radiologists.

  19. Lumbar Disk Herniation in the Spine Patient Outcomes Research Trial (SPORT): Does Educational Attainment Impact Outcome?

    Science.gov (United States)

    Olson, Patrick R.; Lurie, Jon D.; Frymoyer, John; Walsh, Thomas; Zhao, Wenyan; Abdu, William A.; Weinstein, James N.

    2011-01-01

    Study Design Randomized trial with concurrent observational cohort. 1171 patients were divided into subgroups by educational attainment: high school or less, some college, and college degree or above. Objective To assess the influence of education level on outcomes for treatment of lumbar disk herniation. Summary of Background Data Educational attainment has been demonstrated to have an inverse relationship with pain perception, co-morbidities, and mortality. Methods The Spine Patient Outcomes Research Trial enrolled surgical candidates (imaging-confirmed disk herniation with at least 6 weeks of persistent signs and symptoms of radiculopathy) from 13 multidisciplinary spine clinics in 11 US states. Treatments were standard open diskectomy vs. non-operative treatment. Outcomes were changes from baseline for SF-36 bodily pain (BP) and physical function (PF) scales and the modified Oswestry Disability Index (ODI) at 6 weeks, 3 months, 6 months, and yearly through 4 years. Results Substantial improvement was seen in all patient cohorts. Surgical outcomes did not differ by level of education. For non-operative outcomes, however, higher levels of education were associated with significantly greater overall improvement over 4 years in BP (p=0.007), PF (p=0.001) and ODI (p=0.003). At 4 years a “dose-response” type relationship was shown for BP (high school or less 25.5; some college 31; college graduate or above 36.3; p= 0.004); results were similar for PF and ODI. The success of non-operative treatment in the more educated cohort resulted in an attenuation of the relative benefit of surgery. Conclusions Patients with higher educational attainment demonstrated significantly greater improvement with non-operative treatment while educational attainment was not associated with surgical outcomes. PMID:21311402

  20. Site versus centralized raters in a clinical depression trial: impact on patient selection and placebo response.

    Science.gov (United States)

    Kobak, Kenneth A; Leuchter, Andrew; DeBrota, David; Engelhardt, Nina; Williams, Janet B W; Cook, Ian A; Leon, Andrew C; Alpert, Jonathan

    2010-04-01

    The use of centralized raters who are remotely linked to sites and interview patients via videoconferencing or teleconferencing has been suggested as a way to improve interrater reliability and interview quality. This study compared the effect of site-based and centralized ratings on patient selection and placebo response in subjects with major depressive disorder. Subjects in a 2-center placebo and active comparator controlled depression trial were interviewed twice at each of 3 time points: baseline, 1-week postbaseline, and end point--once by the site rater and once remotely via videoconference by a centralized rater. Raters were blind to each others' scores. A site-based score of greater than 17 on the 17-item Hamilton Depression Rating Scale (HDRS-17) was required for study entry. When examining all subjects entering the study, site-based raters' HDRS-17 scores were significantly higher than centralized raters' at baseline and postbaseline but not at end point. At baseline, 35% of subjects given an HDRS-17 total score of greater than 17 by a site rater were given an HDRS total score of lower than 17 by a centralized rater and would have been ineligible to enter the study if the centralized rater's score was used to determine study entry. The mean placebo change for site raters (7.52) was significantly greater than the mean placebo change for centralized raters (3.18, P 50% reduction in HDRS) based on site ratings versus 14% for central ratings (P site and centralized raters agreed were eligible for the study, there was no significant difference in the HDRS-17 scores. Findings suggest that the use of centralized raters could significantly change the study sample in a major depressive disorder trial and lead to significantly less change in mood ratings among those randomized to placebo.

  1. Impact of RAV1-engineering on poplar biomass production: a short-rotation coppice field trial.

    Science.gov (United States)

    Moreno-Cortés, Alicia; Ramos-Sánchez, José Manuel; Hernández-Verdeja, Tamara; González-Melendi, Pablo; Alves, Ana; Simões, Rita; Rodrigues, José Carlos; Guijarro, Mercedes; Canellas, Isabel; Sixto, Hortensia; Allona, Isabel

    2017-01-01

    Early branching or syllepsis has been positively correlated with high biomass yields in short-rotation coppice (SRC) poplar plantations, which could represent an important lignocellulosic feedstock for the production of second-generation bioenergy. In prior work, we generated hybrid poplars overexpressing the chestnut gene RELATED TO ABI3/VP1 1 (CsRAV1), which featured c. 80% more sylleptic branches than non-modified trees in growth chambers. Given the high plasticity of syllepsis, we established a field trial to monitor the performance of these trees under outdoor conditions and a SRC management. We examined two CsRAV1-overexpression poplar events for their ability to maintain syllepsis and their potential to enhance biomass production. Two poplar events with reduced expression of the CsRAV1 homologous poplar genes PtaRAV1 and PtaRAV2 were also included in the trial. Under our culture conditions, CsRAV1-overexpression poplars continued developing syllepsis over two cultivation cycles. Biomass production increased on completion of the first cycle for one of the overexpression events, showing unaltered structural, chemical, or combustion wood properties. On completion of the second cycle, aerial growth and biomass yields of both overexpression events were reduced as compared to the control. These findings support the potential application of CsRAV1-overexpression to increase syllepsis in commercial elite trees without changing their wood quality. However, the syllepsis triggered by the introduction of this genetic modification appeared not to be sufficient to sustain and enhance biomass production.

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

    Directory of Open Access Journals (Sweden)

    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.

  3. How should the impact of different presentations of treatment effects on patient choice be evaluated? A pilot randomized trial.

    Directory of Open Access Journals (Sweden)

    Cheryl Carling

    Full Text Available BACKGROUND: Different presentations of treatment effects can affect decisions. However, previous studies have not evaluated which presentations best help people make decisions that are consistent with their own values. We undertook a pilot study to compare different methods for doing this. METHODS AND FINDINGS: We conducted an Internet-based randomized trial comparing summary statistics for communicating the effects of statins on the risk of coronary heart disease (CHD. Participants rated the relative importance of treatment consequences using visual analogue scales (VAS and category rating scales (CRS with five response options. We randomized participants to either VAS or CRS first and to one of six summary statistics: relative risk reduction (RRR and five absolute measures of effect: absolute risk reduction, number needed to treat, event rates, tablets needed to take, and natural frequencies (whole numbers. We used logistic regression to determine the association between participants' elicited values and treatment choices. 770 participants age 18 or over and literate in English completed the study. In all, 13% in the VAS-first group failed to complete their VAS rating, while 9% of the CRS-first group failed to complete their scoring (p = 0.03. Different ways of weighting the elicited values had little impact on the analyses comparing the different presentations. Most (51% preferred the RRR compared to the other five summary statistics (1% to 25%, p = 0.074. However, decisions in the group presented the RRR deviated substantially from those made in the other five groups. The odds of participants in the RRR group deciding to take statins were 3.1 to 5.8 times that of those in the other groups across a wide range of values (p = 0.0007. Participants with a scientific background, who were more numerate or had more years of education were more likely to decide not to take statins. CONCLUSIONS: Internet-based trials comparing different presentations

  4. Impact of an informed choice invitation on uptake of screening for diabetes in primary care (DICISION): trial protocol.

    Science.gov (United States)

    Mann, Eleanor; Prevost, A Toby; Griffin, Simon; Kellar, Ian; Sutton, Stephen; Parker, Michael; Sanderson, Simon; Kinmonth, Ann Louise; Marteau, Theresa M

    2009-02-20

    Screening invitations have traditionally been brief, providing information only about population benefits. Presenting information about the limited individual benefits and potential harms of screening to inform choice may reduce attendance, particularly in the more socially deprived. At the same time, amongst those who attend, it might increase motivation to change behavior to reduce risks. This trial assesses the impact on attendance and motivation to change behavior of an invitation that facilitates informed choices about participating in diabetes screening in general practice. Three hypotheses are tested: 1. Attendance at screening for diabetes is lower following an informed choice compared with a standard invitation. 2. There is an interaction between the type of invitation and social deprivation: attendance following an informed choice compared with a standard invitation is lower in those who are more rather than less socially deprived. 3. Amongst those who attend for screening, intentions to change behavior to reduce risks of complications in those subsequently diagnosed with diabetes are stronger following an informed choice invitation compared with a standard invitation. 1500 people aged 40-69 years without known diabetes but at high risk are identified from four general practice registers in the east of England. 1200 participants are randomized by households to receive one of two invitations to attend for diabetes screening at their general practices. The intervention invitation is designed to facilitate informed choices, and comprises detailed information and a decision aid. A comparison invitation is based on those currently in use. Screening involves a finger-prick blood glucose test. The primary outcome is attendance for diabetes screening. The secondary outcome is intention to change health related behaviors in those attenders diagnosed with diabetes. A sample size of 1200 ensures 90% power to detect a 10% difference in attendance between arms, and in

  5. 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

  6. Reducing juvenile delinquency with automated cell phone calls.

    Science.gov (United States)

    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.

  7. 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)

  8. 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)

  9. The impact of the survivorship care plan on health care use : 2 year follow up results of the rogy care trial

    NARCIS (Netherlands)

    Jeppesen, M.M.; Ezendam, N.P.M.; Pijnenborg, J.M.A.; Vos, M.C.; Boll, D.; Kruitwagen, R.F.P.M.; Jensen, P.T.; van de Poll, L.

    2017-01-01

    Purpose The purpose of this paper was to assess the impact of survivorship care plan (SCP) provision and moderating factors on health care use following endometrial cancer treatment. Methods Women newly diagnosed with endometrial cancer were included in a pragmatic cluster randomized trial at 12

  10. Impact of a daily exercise dose on knee joint cartilage - a systematic review and meta-analysis of randomized controlled trials in healthy animals

    DEFF Research Database (Denmark)

    Bricca, A; Juhl, C B; Grodzinsky, A J

    2017-01-01

    OBJECTIVE: To investigate the impact of a daily exercise dose on cartilage composition and thickness, by conducting a systematic review of randomized controlled trials (RCTs) involving healthy animals. METHODS: A narrative synthesis of the effect of a daily exercise dose on knee cartilage aggrecan...

  11. Impact on Clinical Behavior of Face-to-Face Continuing Medical Education Blended with Online Spaced Education: A Randomized Controlled Trial

    Science.gov (United States)

    Shaw, Timothy; Long, Andrea; Chopra, Sanjiv; Kerfoot, B. Price

    2011-01-01

    Background: Spaced education (SE) is a novel, evidence-based form of online learning. We investigated whether an SE program following a face-to-face continuing medical education (CME) course could enhance the course's impact on providers' clinical behaviors. Methods: This randomized controlled trial was conducted from March 2009 to April 2010,…

  12. Correction to: Impact of an electronic monitoring device and behavioural feedback on adherence to multiple sclerosis therapies in youth: results of a randomized trial.

    Science.gov (United States)

    Yeh, E Ann; Grover, Stephanie A; Powell, Victoria E; Alper, Gulay; Banwell, Brenda L; Edwards, Kim; Gorman, Mark; Graves, Jennifer; Lotze, Timothy E; Mah, Jean K; Mednick, Lauren; Ness, Jayne; Obadia, Maya; Slater, Ruth; Waldman, Amy; Waubant, Emmanuelle; Schwartz, Carolyn E

    2017-12-23

    The clinicaltrials.gov identifying number for the article titled "Impact of an electronic monitoring device and behavioral feedback on adherence to multiple sclerosis therapies in youth: results of a randomized trial" is NCT02234713 (https://clinicaltrials.gov/ct2/show/NCT02234713).

  13. Impact of parent-directed education on parental use of pain treatments during routine infant vaccinations: a cluster randomized trial.

    Science.gov (United States)

    Taddio, Anna; Parikh, Chaitya; Yoon, Eugene W; Sgro, Michael; Singh, Harvinder; Habtom, Erita; Ilersich, Andrew F; Pillai Riddell, Rebecca; Shah, Vibhuti

    2015-01-01

    Educating parents about ways to minimize pain during routine infant vaccine injections at the point of care may positively impact on pain management practices. The objective of this cluster randomized trial was to determine the impact of educating parents about pain in outpatient pediatric clinics on their use of pain treatments during routine infant vaccinations. Four hospital-based pediatric clinics were randomized to intervention or control groups. Parents of 2- to 4-month-old infants attending the intervention clinics reviewed a pamphlet and a video about vaccination pain management on the day of vaccination, whereas those in the control clinics did not. Parent use of specific pain treatments (breastfeeding, sugar water, topical anesthetics, and/or holding of infants) on the education day and at subsequent routine vaccinations 2 months later was the primary outcome. Altogether, 160 parent-infant dyads (80 per group) participated between November 2012 and February 2014; follow-up data were available for 126 (79%). Demographics did not differ between groups (P > 0.05). On the education day and at follow-up vaccinations, use of pain interventions during vaccinations was higher in the intervention group (80% vs 26% and 68% vs 32%, respectively; P vaccinations.

  14. Impact and costs of targeted recruitment of minorities to the National Lung Screening Trial.

    Science.gov (United States)

    Duda, Catherine; Mahon, Irene; Chen, Mei Hsiu; Snyder, Bradley; Barr, Richard; Chiles, Caroline; Falk, Robert; Fishman, Elliot K; Gemmel, David; Goldin, Jonathan G; Brown, Kathleen; Munden, Reginald F; Vydareny, Kay; Aberle, Denise R

    2011-04-01

    To promote results in the National Lung Screening Trial (NLST) that are generalizable across the entire US population, a subset of NLST sites developed dedicated strategies for minority recruitment. To report the effects of targeted strategies on the accrual of underrepresented groups, to describe participant characteristics, and to estimate the costs of targeted enrollment. The 2002-2004 Tobacco Use Supplement was used to estimate eligible proportions of racial and ethnic categories. Strategic planning included meetings/conferences with key stakeholders and minority organizations. Potential institutions were selected based upon regional racial/ethnic diversity and proven success in recruitment of underrepresented groups. Seven institutions submitted targeted recruitment strategies with budgets. Accrual by racial/ethnic category was tracked for each institution. Cost estimates were based on itemized receipts for minority strategies relative to minority accrual. Of 18,842 participants enrolled, 1576 (8.4%) were minority participants. The seven institutions with targeted recruitment strategies accounted for 1223 (77.6%) of all minority participants enrolled. While there was a significant increase in the rate of minority accrual pre-implementation to post-implementation for the institutions with targeted recruitment (9.3% vs. 15.2%, p institutions without (3.5% vs. 3.8%, p = 0.46). Minority enrollees at the seven institutions tended to have less than a high school education, be economically disadvantaged, and were more often uninsured. These socio-demographic differences persisted at the seven institutions even after adjusting for race and ethnicity. The success of different strategies varied by institution, and no one strategy was successful across all institutions. Costs for implementation were also highly variable, ranging from $146 to $749 per minority enrollee. Data on minority recruitment processes were not consistently kept at the individual institutions. In

  15. Impact of an integrated intervention program on atorvastatin adherence: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Goswami NJ

    2013-07-01

    Full Text Available Nilesh J Goswami,1 Mitch DeKoven,2 Andreas Kuznik,3 Jack Mardekian,3 Michelle R Krukas,2 Larry Z Liu,3,4 Patrick Bailey,1 Cynthia Deitrick,5 John Vincent3 1Prairie Heart Cardiovascular Consultants, Springfield, IL, USA; 2Health Economics and Outcomes Research, IMS Health, Alexandria, VA, USA; 3Pfizer Inc, New York, NY, USA; 4Weill Cornell Medical College, Cornell University, New York, NY, USA; 5Prairie Heart Education and Research Cooperative, Springfield, IL, USA Background: This trial evaluated the effectiveness of an integrated intervention program that included a 3-to-5-minute nurse counseling session, copay relief cards, and a monthly newsletter on adherence to atorvastatin treatment. Methods and results: A prospective, integrated (composed of nurse counseling, adherence tip sheet, copay relief card, opportunity to enroll in 12-week cholesterol management program randomized interventional study was designed involving patients >21 years of age who were prescribed atorvastatin at a large single-specialty cardiovascular physician practice in Illinois from March 2010 to May 2011. Data from the practice's electronic medical record were matched/merged to IMS Health's longitudinal data. A total of 500 patients were enrolled (125 in the control arm; 375 in the intervention arm. After data linkage, 53 control patients and 155 intervention patients were included in the analysis. Results: Mean age was 67.8 years (control and 69.5 years (intervention; 67.9% and 58.7%, respectively, were male. The mean 6-month adherence rate was 0.82 in both arms. The mean proportion of days covered for both the new-user control and intervention groups was the same, averaging 0.70 day (standard deviation [SD], 0.27 day; for continuing users, the proportion of days covered for the control group was 0.83 (SD, 0.24 and for the intervention group was 0.84 (SD, 0.22. For continuing users, the control group had mean persistent days of 151.6 (SD, 50.2 compared with 150.9 days

  16. FFCD-1004 Clinical Trial: Impact of Cytidine Deaminase Activity on Clinical Outcome in Gemcitabine-Monotherapy Treated Patients.

    Directory of Open Access Journals (Sweden)

    Cindy Serdjebi

    Full Text Available Because cytidine deaminase (CDA is the key enzyme in gemcitabine metabolism, numerous studies have attempted to investigate impact of CDA status (i.e. genotype or phenotype on clinical outcome. To date, data are still controversial because none of these studies has fully investigated genotype-phenotype CDA status, pharmacokinetics and clinical outcome relationships in gemcitabine-treated patients. Besides, most patients were treated with gemcitabine associated with other drugs, thus adding a confounding factor. We performed a multicenter prospective clinical trial in gemcitabine-treated patients which aimed at investigating the link between CDA deficiency on the occurrence of severe toxicities and on pharmacokinetics, and studying CDA genotype-phenotype relationships.One hundred twenty patients with resected pancreatic adenocarcinoma eligible for adjuvant gemcitabine monotherapy were enrolled in this study promoted and managed by the Fédération Francophone de Cancérologie Digestive. Toxicities were graded according to National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4. They were considered severe for grade ≥ 3, and early when occurring during the first eight weeks of treatment. CDA status was evaluated using a double approach: genotyping for 79A>C and functional testing. Therapeutic drug monitoring of gemcitabine and its metabolite were performed on the first course of gemcitabine.Five patients out of 120 (i.e., 4.6% were found to be CDA deficient (i.e., CDA activity <1.3 U/mg, and only one among them experienced early severe hematological toxicity. There was no statistically significant difference in CDA activity between patients experiencing hematological severe toxicities (28.44% and patients who tolerated the treatment (71.56%. CDA genetic analysis failed in evidencing an impact in terms of toxicities or in CDA activity. Regarding pharmacokinetics, a wide inter-individual variability has been observed

  17. Calle y Saberes en Movimiento

    Directory of Open Access Journals (Sweden)

    Laura Daniela Aguirre Aguilar

    2010-05-01

    Full Text Available En México el rezago, el ausentismo, la deserción escolar, el trabajo a temprana edad y el inicio de una vida en la calle, en repetidas ocasiones son consecuencia de un núcleo familiar desarticulado o de una débil relación intrafamiliar, así como de una condición socioeconómica en desventaja. Ante esta problemática, la Secretaría de Educación Pública, instancia gubernamental encargada de garantizar una educación de calidad para la población, trabaja coordinadamente con organizaciones de la sociedad civil e instancias públicas, para la reintegración a los espacios educativos de los niños, niñas y jóvenes en situación de calle.

  18. Calle y Saberes en Movimiento

    Directory of Open Access Journals (Sweden)

    Laura Daniela Aguirre Aguilar

    2010-01-01

    Full Text Available En México el rezago, el ausentismo, la deserción escolar, el trabajo a temprana edad y el inicio de una vida en la calle, en repetidas ocasiones son consecuencia de un núcleo familiar desarticulado o de una débil relación intrafamiliar, así como de una condición socioeconómica en desventaja. Ante esta problemática, la Secretaría de Educación Pública, instancia gubernamental encargada de garantizar una educación de calidad para la población, trabaja coordinadamente con organizaciones de la sociedad civil e instancias públicas, para la reintegración a los espacios educativos de los niños, niñas y jóvenes en situación de calle.

  19. The impact of brief parental anxiety management on child anxiety treatment outcomes: a controlled trial.

    Science.gov (United States)

    Hudson, Jennifer L; Newall, Carol; Rapee, Ronald M; Lyneham, Heidi J; Schniering, Carolyn C; Wuthrich, Viviana M; Schneider, Sophie; Seeley-Wait, Elizabeth; Edwards, Susan; Gar, Natalie S

    2014-01-01

    Parental anxiety is a risk to optimal treatment outcomes for childhood anxiety disorders. The current trial examined whether the addition of a brief parental anxiety management (BPAM) program to family cognitive behavioral therapy (CBT) was more efficacious than family CBT-only in treating childhood anxiety disorders. Two hundred nine children (aged 6-13 years, 104 female, 90% Caucasian) with a principal anxiety disorder were randomly allocated to family CBT with a five-session program of BPAM (n = 109) or family CBT-only (n = 100). Family CBT comprised the Cool Kids program, a structured 12-week program that included both mothers and fathers. Overall, results revealed that the addition of BPAM did not significantly improve outcomes for the child or the parent compared to the CBT-only group at posttreatment or 6-month follow-up. Overall, however, children with nonanxious parents were more likely to be diagnosis free for any anxiety disorder compared to children with anxious parents at posttreatment and 6-month follow-up. BPAM did not produce greater reductions in parental anxiety. The results support previous findings that parent anxiety confers poorer treatment outcomes for childhood anxiety disorders. Nevertheless the addition of BPAM anxiety management for parents in its current format did not lead to additional improvements when used as an adjunct to family CBT in the treatment of the child's anxiety disorder. Future benefits may come from more powerful methods of reducing parents' anxiety.

  20. Impact on patients and partners of inpatient and extended cardiac counseling and rehabilitation: a controlled trial.

    Science.gov (United States)

    Johnston, M; Foulkes, J; Johnston, D W; Pollard, B; Gudmundsdottir, H

    1999-01-01

    This study evaluated the effectiveness of cardiac counseling and rehabilitation programs led by a nurse counselor, compared with normal care on outcomes for myocardial infarction (MI) patients and their partners. A randomized controlled trial with follow-up to 1 year was conducted with 100 patients recruited within 72 hours of a first MI and their partners: a Control group received normal care; an Inpatient group received cardiac rehabilitation from a nurse counselor while in hospital; and an Extended group received the same cardiac rehabilitation as the Inpatient group, but with additional sessions continuing up to 6 weeks after discharge from hospital. The scales for main outcome measures were 1) knowledge of heart disease and treatment (correct, misconceptions, and uncertainty); 2) mood (Hospital Anxiety and Depression Scale); 3) satisfaction; 4) disability (Functional Limitations Profile). Inpatient cardiac counseling and rehabilitation resulted in more knowledge, less anxiety, less depression, and greater satisfaction with care in both patients and partners and in less disability in patients, with effects enduring to 1 year. There was some evidence of additional benefit from the Extended program. Both nurse counselors achieved benefits on all outcome variables. This Inpatient cardiac counseling and rehabilitation program resulted in significant and enduring benefits of clinical value. It is likely that it would be acceptable to most post-MI patients, many of whom are not offered or are unable to accept outpatient cardiac rehabilitation.

  1. Impact of exposure to positive images on dental anxiety among children: a controlled trial.

    Science.gov (United States)

    Ramos-Jorge, M L; Ramos-Jorge, J; Vieira de Andrade, R G; Marques, L S

    2011-08-01

    To determine whether exposing children to images of positive dental care would have an effect on their degree of anxiety, assessing anxiety three separate times. Controlled trial. The 70 participants from 4-11 years of age were randomly assigned to one of two conditions. The intervention consisted of viewing positive images of dentistry and dental treatment (n=35). The control condition consisted of dentally neutral images (n=35). Anxiety was assessed using the Venham Picture Test (VPT) prior to the intervention, immediately following the intervention and following the dental appointment. Statistical analysis (chisquare and Mann-Whitney tests) was conducted blind to group allocation. No significant difference was detected between the scores of the VPT in the two groups at any evaluation time (p>0.05). Dental anxiety at the three evaluation times was not correlated to age. There was no difference in level of anxiety between male and female participants (p>0.05). Viewing positive images of dentistry and dentists did not have a greater effect on child anxiety in the dental setting than viewing neutral images, however, showed lower rates of anxiety for all children although this was not significant.

  2. Mild traumatic brain injuries: the impact of early intervention on late sequelae. A randomized controlled trial.

    Science.gov (United States)

    Elgmark Andersson, E; Emanuelson, I; Björklund, R; Stålhammar, D A

    2007-02-01

    Positive results from early clinical intervention of mild traumatic brain injury (MTBI) patients by rehabilitation specialists have been reported. Various treatments have been used, but few controlled studies are published. We hypothesised that early rehabilitation of selected MTBI patients would reduce long term sequelae. A randomised controlled trial with one year follow-up. Among 1719 consecutive patients with MTBI, 395 individuals, 16-60 years of age, met the MTBI definition. Exclusion criteria were: previous clinically significant brain disorders and/or a history of substance abuse. The control group (n = 131) received regular care. The intervention group (n = 264) was examined by a rehabilitation specialist. 78 patients were mainly referred to an occupational therapist. The problems were identified in daily activities and in terms of post-concussion symptoms (PCS), an individualised, tailored treatment was given. Primary endpoint was change in rate of PCS and in life satisfaction at one-year follow-up between the groups. No statistical differences were found between the intervention and control groups. Patients who experienced few PCS two to eight weeks after the injury and declined rehabilitation recovered and returned to their pre-injury status. Patients who suffered several PCS and accepted rehabilitation did not recover after one year. In this particular MTBI sample, early active rehabilitation did not change the outcome to a statistically-significant degree. Further studies should focus on patients with several complaints during the first 1-3 months and test various types of interventions.

  3. Full impact of laboratory information system requires direct use by clinical staff: cluster randomized controlled trial.

    Science.gov (United States)

    Blaya, Joaquín A; Shin, Sonya; Contreras, Carmen; Yale, Gloria; Suarez, Carmen; Asencios, Luis; Kim, Jihoon; Rodriguez, Pablo; Cegielski, Peter; Fraser, Hamish S F

    2011-01-01

    To evaluate the time to communicate laboratory results to health centers (HCs) between the e-Chasqui web-based information system and the pre-existing paper-based system. Cluster randomized controlled trial in 78 HCs in Peru. In the intervention group, 12 HCs had web access to results via e-Chasqui (point-of-care HCs) and forwarded results to 17 peripheral HCs. In the control group, 22 point-of-care HCs received paper results directly and forwarded them to 27 peripheral HCs. Baseline data were collected for 15 months. Post-randomization data were collected for at least 2 years. Comparisons were made between intervention and control groups, stratified by point-of-care versus peripheral HCs. For point-of-care HCs, the intervention group took less time to receive drug susceptibility tests (DSTs) (median 9 vs 16 days, p60 days to arrive (pChasqui information system had reduced communication times and fewer results with delays of >2 months. Peripheral HCs had no benefits from the system. This suggests that health establishments should have point-of-care access to reap the benefits of electronic laboratory reporting.

  4. [Impact of a multidimensional intervention in elderly patients with community-acquired pneumonia: IMIEPCAP clinical trial].

    Science.gov (United States)

    Torres, Olga Herminia; Gil, Eva; Comas, Maria Teresa; Saez, Maria Encarnación; Clotet, Sandra; Ramirez, Hector David; Mateo, Miriam; Ruiz, Domingo

    2016-01-01

    The main objective of this study is to determine whether a multidimensional intervention applied to elderly patients admitted to hospital due to pneumonia reduces re-admissions and emergency department visits in the year after the intervention. This is a single-centre non-pharmacological randomised clinical trial with a parallel design. Three hundred and fourteen patients will be included (157 in each arm). Eligible patients will be ≥65 years old and with a Barthel index ≥60 that are admitted to hospital due to pneumonia. Participants will be randomised to multidimensional intervention or to control group. Two months after hospital discharge the intervention group will receive a geriatric intervention, carried out by a nurse and a physician. It will include assessment of co-morbidities, nutritional, functional and cognitive status, and immunisation. The control group will receive conventional follow-up. The number of re-admissions, visits to the emergency department, functional status, survival, and institutionalisation will be evaluated one year after intervention. If the intervention shows an improvement in the studied outcomes, it would allow us to improve individual outcomes, and indirectly reduce healthcare costs using a relatively simple, standardised tool. Copyright © 2015 SEGG. Published by Elsevier Espana. All rights reserved.

  5. Clinical Impact of Pharmacogenetic-Guided Treatment for Patients Exhibiting Neuropsychiatric Disorders: A Randomized Controlled Trial.

    Science.gov (United States)

    Olson, Marilyn C; Maciel, Alejandra; Gariepy, Jean Francois; Cullors, Ali; Saldivar, Juan-Sebastian; Taylor, David; Centeno, Joel; Garces, Jorge A; Vaishnavi, Sandeep

    2017-03-16

    Pharmacogenetic testing holds promise as a personalized medicine tool by permitting individualization of pharmacotherapy in accordance with genes influencing therapeutic response, side effects, and adverse events. The authors evaluated the effect on outcomes for patients diagnosed with neuropsychiatric disorders of pharmacogenetics (PGx)-guided treatment compared to usual standard of care. This was a prospective, randomized study of 237 patients at an outpatient community-based psychiatric practice conducted between April 2015 and October 2015. Baseline patient assessments and a buccal swab were collected for pharmacogenetic testing at study initiation. For the experimental group, PGx results were provided to the clinicians as guides to treatment. Control subjects were treated according to the usual standard of care with no clinician reference to their PGx results. Neuropsychiatric Questionnaire (NPQ) and Symbol Digit Coding Test (SDC) scores and adverse drug events, hospitalizations, and medication information were collected at 30, 60, and 90 days. More than half (53%) of patients in the control group reported at least 1 adverse drug event compared to 28% of patients with PGx-guided medication management (P = .001). NPQ and SDC scores improved for both groups, but no statistical difference in efficacy as measured by these assessments was observed within the 90-day observation period. Pharmacogenetic testing may facilitate psychiatric drug therapy with greater tolerability and similar efficacy compared to standard of care. ClinicalTrials.gov Identifier: NCT02411123​​.

  6. Armed calling for sur plus

    Directory of Open Access Journals (Sweden)

    Andréa Limberto Leite

    2013-12-01

    Full Text Available The most recent work by researcher José Luiz Aidar Prado, Convocações biopolíticas dos dispositivos comunicacionais (freely translated as Biopolitic convoking of communicational dispositives puts the reader straight in the face of the calling to enter circulating discourses. They are directed to all subjects and also accomodate the discourses with urgence for consumption. 

  7. Ultrasound call detection in capybara

    Directory of Open Access Journals (Sweden)

    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.

  8. 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. ClinicalTrials.gov NCT02184715.

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

    Directory of Open Access Journals (Sweden)

    Ru-Lan Hsieh

    Full Text Available 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.ClinicalTrials.gov NCT02184715.

  10. The impact of social skills training for social anxiety disorder: a randomized controlled trial.

    Science.gov (United States)

    Beidel, Deborah C; Alfano, Candice A; Kofler, Michael J; Rao, Patricia A; Scharfstein, Lindsay; Wong Sarver, Nina

    2014-12-01

    Social anxiety disorder (SAD) impacts social, occupational and academic functioning. Although many interventions report change in social distress, improvement in social behavior remains under-addressed. This investigation examined the additive impact of social skills training (SST) for the treatment of SAD. Using a sample of 106 adults who endorsed SAD across numerous social settings, participants were randomized to exposure therapy (imaginal and in vivo) alone, a combination of SST and exposure therapy known as Social Effectiveness Therapy (SET), or a wait list control. The assessment strategy included self-report measures, blinded clinical ratings and blinded assessment of social behavior. Both interventions significantly reduced distress in comparison to the wait list control and at post-treatment, 67% of patients treated with SET and 54% of patients treated with exposure therapy alone no longer met diagnostic criteria for SAD, a difference that was not statistically significant. When compared to exposure therapy alone, SET produced superior outcomes (p<.05) on measures of social skill and general clinical status. In addition to statistical significance, participants treated with SET or exposure reported clinically significant decreases on two measures of self-reported social anxiety and several measures of observed social behavior (all ps<.05). Both interventions produced efficacious treatment outcome, although SET may provide additional benefit on measures of social distress and social behavior. Copyright © 2014 Elsevier Ltd. All rights reserved.

  11. [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.

  12. Impact of a simulation training curriculum on technical and nontechnical skills in colonoscopy: a randomized trial.

    Science.gov (United States)

    Grover, Samir C; Garg, Ankit; Scaffidi, Michael A; Yu, Jeffrey J; Plener, Ian S; Yong, Elaine; Cino, Maria; Grantcharov, Teodor P; Walsh, Catharine M

    2015-12-01

    GI endoscopy simulation-based training augments early clinical performance; however, the optimal manner by which to deliver training is unknown. We aimed to validate a simulation-based structured comprehensive curriculum (SCC) designed to teach technical, cognitive, and integrative competencies in colonoscopy. Single-blinded, randomized, controlled trial. Endoscopic simulation course at an academic hospital. Thirty-three novice endoscopists were allocated to an SCC group or self-regulated learning (SRL) group. The SCC group received a curriculum consisting of 6 hours of didactic lectures and 8 hours of virtual reality simulation-based training with expert feedback. The SRL group was provided a list of desired objectives and was instructed to practice on the simulator for an equivalent time (8 hours). Clinical transfer was assessed during 2 patient colonoscopies using the Joint Advisory Group Direct Observation of Procedural Skills (JAG DOPS) scale. Secondary outcome measures included differences in procedural knowledge, immediate post-training simulation performance, and delayed post-training (4-6 weeks) performance during an integrated scenario test on the JAG DOPS communication and integrated scenario global rating scales. There was no significant difference in baseline or post-training performance on the simulator task. The SCC group performed superiorly during their first and second clinical colonoscopies. Additionally, the SCC group demonstrated significantly better knowledge and colonoscopy-specific performance, communication, and global performance during the integrated scenario. We were unable to measure SRL participants' effort outside of mandatory training. In addition, feedback metrics and number of available simulation cases are limited. These results support integration of endoscopy simulation into a structured curriculum incorporating instructional feedback and complementary didactic knowledge as a means to augment technical, cognitive, and

  13. Impact of a personalized versus moderate-intensity exercise prescription: a randomized controlled trial.

    Science.gov (United States)

    Schneider, Margaret; Schmalbach, Priel; Godkin, Sophia

    2017-04-01

    Effective approaches to promote adolescent physical activity are needed. Moreover, a one-size-fits-all approach has been minimally successful to date. This randomized controlled trial evaluates a theory-based personalized exercise prescription to enhance motivation for being active and physical activity participation among adolescent reluctant exercisers. Adolescents were characterized by affective style as reluctant (predisposed to negative affect during exercise) or latent (predisposed to positive affect during exercise) exercisers based on their affective response to an acute exercise task, and then randomly assigned to an exercise prescription of either a personalized or a moderate intensity. Assignment was double-blind. Assessments were pre- and post- the 8-week intervention. Participants were an ethnically diverse group of adolescents (19 % non-Latino White) in a public middle-school. The exercise intensity manipulation and assessments took place at the school site during regular Physical Education. Participants were assigned to either a moderate-intensity exercise prescription [target heart rate (HR) range 60-80 % of HR max] or a personalized exercise prescription corresponding to an intensity that "feels good" to the individual for 8 weeks during daily Physical Education. Outcome measures included exercise-related intrinsic motivation (via questionnaire), and daily moderate-to-vigorous physical activity (MVPA; via accelerometer). The exercise intensity manipulation did not yield actual differences in exercise intensity during PE, and had no effect on either Intrinsic Motivation or MVPA. There was no significant interaction between affective style and group assignment in predicting Intrinsic Motivation or MVPA. This study did not find support for a link between affective experiences during exercise and physical activity participation. Providing adolescents with a personalized exercise intensity prescription and asking them to follow the prescription

  14. The impact of supportive counselling on women's psychological wellbeing after miscarriage--a randomised controlled trial.

    Science.gov (United States)

    Kong, G W S; Chung, T K H; Lok, I H

    2014-09-01

    To assess the effectiveness of supportive counselling after miscarriage. Randomised controlled trial. University hospital. Two hundred and eighty women with miscarriage. Women were randomised to receive supportive counselling from a nurse (at diagnosis and 2 weeks later) or routine care. Psychological wellbeing was measured with the General Health Questionnaire (GHQ-12) and Beck Depression Inventory (BDI). Primary outcome measured the proportion of women suffering psychological distress (GHQ-12 score ≥4) at 3 months after miscarriage. Secondary outcomes were GHQ-12 and BDI scores at 6 weeks, 3 and 6 months. There was no difference in the proportion of women suffering psychological distress at 3 months after miscarriage (17.1% in counselling group versus 24.4% in control group; 95% CI -0.034 to 0.177; P = 0.19). However, for the subgroup of women (n = 152) with high baseline GHQ-12 scores, the median GHQ-12 score in the counselling group was significantly lower than the control group at 6 weeks (median score 3 versus 4.5 in counselling and control groups; P = 0.04) and 3 months (median score 1 versus 2.5 in counselling and control groups; P = 0.03). Similarly, for women with high baseline BDI scores (BDI > 12), the proportion for women continuing to score high was significantly lower in the counselling group 6 weeks after miscarriage (33.3 versus 61.1% in counselling group and control group; P = 0.03). Although the results of current study do not justify routine counselling of all women following miscarriage, a supportive counselling programme for selected women with high levels of psychological distress is promising and merits further investigation. © 2014 Royal College of Obstetricians and Gynaecologists.

  15. Impact of common crystalloid solutions on resuscitation markers following Class I hemorrhage: A randomized control trial.

    Science.gov (United States)

    Ross, Samuel W; Christmas, A Britton; Fischer, Peter E; Holway, Haley; Walters, Amanda L; Seymour, Rachel; Gibbs, Michael A; Heniford, B Todd; Sing, Ronald F

    2015-11-01

    Resuscitation after hemorrhage with crystalloid solutions can lead to marked acidosis and iatrogenically worsen the lethal triad. The effect of differing solutions on base deficit and lactate has been sparsely prospectively studied in humans. We sought to quantify the effect of normal saline (NS) and lactated Ringer's (LR) resuscitation in voluntary blood donors as a model for Class I hemorrhage. A prospective randomized control trial was conducted in conjunction with blood drives. Donors were randomized to receive no intravenous fluid (noIVF), 2-L NS, or 2-L LR after blood donation of 500 mL. Lactate and base deficit were measured before and after fluid administration using an iSTAT. The mean laboratory values were compared between groups first using a global test followed by pairwise testing between groups using the Wilcoxon rank-sum and Kruskal-Wallis tests. The Bonferroni correction was used and a statistical significance of p 0.0167). Donors had comparable increases in lactate and base deficit after donation regardless of the group (p > 0.0167). After resuscitation with 2-L crystalloid, the lactate level increased higher in the LR group than in the noIVF or the NS group (1.36 mmol/L vs. 1.00 mmol/L vs. 1.54 mmol/L, p < 0.0001). In addition, the resuscitation base deficit increased in the NS group more than in the noIVF or LR group (-0.65 vs. -3.06 vs. -0.34, p < 0.0001). This study is one of the first human studies to prospectively demonstrate quantifiable differences in base deficit and lactate by type of crystalloid resuscitation. LR resuscitation elevated lactate levels, and NS negatively affected the base deficit. These findings are critical to the interpretation of trauma patient resuscitation with crystalloid solutions. Therapeutic study, level II.

  16. 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.

  17. An experimental trial exploring the impact of continuous transdermal alcohol monitoring upon alcohol consumption in a cohort of male students.

    Directory of Open Access Journals (Sweden)

    Fergus G Neville

    Full Text Available To examine the impact of continuous transdermal alcohol monitoring upon alcohol consumption in male students at a Scottish university.Using a within-subject mixed-methods design, 60 male university students were randomly allocated into three experimental conditions using AUDIT score stratified sampling. Participants in Conditions A and B were asked not to consume alcohol for a 14-day period, with those in Condition A additionally being required to wear a continuous transdermal alcohol monitoring anklet. Condition C participants wore an anklet and were asked to continue consuming alcohol as normal. Alcohol consumption was measured through alcohol timeline follow-back, and using data collected from the anklets where available. Diaries and focus groups explored participants' experiences of the trial.Alcohol consumption during the 14-day trial decreased significantly for participants in Conditions A and B, but not in C. There was no significant relative difference in units of alcohol consumed between Conditions A and B, but significantly fewer participants in Condition A drank alcohol than in Condition B. Possible reasons for this difference identified from the focus groups and diaries included the anklet acting as a reminder of commitment to the study (and the agreement to sobriety, participants feeling under surveillance, and the use of the anklet as a tool to resist social pressure to consume alcohol.The study provided experience in using continuous transdermal alcohol monitors in an experimental context, and demonstrated ways in which the technology may be supportive in facilitating sobriety. Results from the study have been used to design a research project using continuous transdermal alcohol monitors with ex-offenders who recognise a link between their alcohol consumption and offending behaviour.

  18. Impact of a Mental Health Curriculum on Knowledge and Stigma Among High School Students: A Randomized Controlled Trial.

    Science.gov (United States)

    Milin, Robert; Kutcher, Stanley; Lewis, Stephen P; Walker, Selena; Wei, Yifeng; Ferrill, Natasha; Armstrong, Michael A

    2016-05-01

    This study evaluated the effectiveness of a school-based mental health literacy intervention for adolescents on knowledge and stigma. A total of 24 high schools and 534 students in the regional area of Ottawa, Ontario, Canada participated in this randomized controlled trial. Schools were randomly assigned to either the curriculum or control condition. The curriculum was integrated into the province's grade 11 and 12 "Healthy Living" courses and was delivered by teachers. Changes in mental health knowledge and stigma were measured using pre- and posttest questionnaires. Descriptive analyses were conducted to provide sample characteristics, and multilevel modeling was used to examine study outcomes. For the curriculum condition, there was a significant change in stigma scores over time (p = .001), with positive attitudes toward mental illness increasing from pre to post. There was also a significant change in knowledge scores over time (p stigma were found for participants in the control condition. A meaningful relationship was found whereby increases in knowledge significantly predicted increases in positive attitudes toward mental health (p mental health literacy of an integrated, manualized mental health educational resource for high school students on knowledge and stigma. Findings also support the applicability by teachers and suggest the potential for broad-based implementation of the educational curriculum in high schools. Replication and further studies are warranted. Clinical trial registration information-Impact of a Mental Health Curriculum for High School Students on Knowledge and Stigma; http://clinicaltrials.gov/; NCT02561780. Copyright © 2016 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

  19. The impact of hotspot-targeted interventions on malaria transmission: study protocol for a cluster-randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bousema Teun

    2013-02-01

    Full Text Available Abstract Background Malaria transmission is highly heterogeneous in most settings, resulting in the formation of recognizable malaria hotspots. Targeting these hotspots might represent a highly efficacious way of controlling or eliminating malaria if the hotspots fuel malaria transmission to the wider community. Methods/design Hotspots of malaria will be determined based on spatial patterns in age-adjusted prevalence and density of antibodies against malaria antigens apical membrane antigen-1 and merozoite surface protein-1. The community effect of interventions targeted at these hotspots will be determined. The intervention will comprise larviciding, focal screening and treatment of the human population, distribution of long-lasting insecticide-treated nets and indoor residual spraying. The impact of the intervention will be determined inside and up to 500 m outside the targeted hotspots by PCR-based parasite prevalence in cross-sectional surveys, malaria morbidity by passive case detection in selected facilities and entomological monitoring of larval and adult Anopheles populations. Discussion This study aims to provide direct evidence for a community effect of hotspot-targeted interventions. The trial is powered to detect large effects on malaria transmission in the context of ongoing malaria interventions. Follow-up studies will be needed to determine the effect of individual components of the interventions and the cost-effectiveness of a hotspot-targeted approach, where savings made by reducing the number of compounds that need to receive interventions should outweigh the costs of hotspot-detection. Trial registration NCT01575613. The protocol was registered online on 20 March 2012; the first community was randomized on 26 March 2012.

  20. Ticagrelor effects on myocardial infarction and the impact of event adjudication in the PLATO (Platelet Inhibition and Patient Outcomes) trial.

    Science.gov (United States)

    Mahaffey, Kenneth W; Held, Claes; Wojdyla, Daniel M; James, Stefan K; Katus, Hugo A; Husted, Steen; Steg, Philippe Gabriel; Cannon, Christopher P; Becker, Richard C; Storey, Robert F; Khurmi, Nardev S; Nicolau, José C; Yu, Cheuk-Man; Ardissino, Diego; Budaj, Andrzej; Morais, Joao; Montgomery, Debra; Himmelmann, Anders; Harrington, Robert A; Wallentin, Lars

    2014-04-22

    This study sought to report the treatment effect of ticagrelor on myocardial infarction (MI) and the strategy for and impact of event adjudication in the PLATO (Platelet Inhibition and Patient Outcomes) trial. In PLATO, ticagrelor reduced cardiovascular death, MI, or stroke in patients with acute coronary syndromes (ACS). A clinical events committee (CEC) prospectively defined and adjudicated all suspected MI events, on the basis of events reported by investigators and by triggers on biomarkers. Treatment comparisons used CEC-adjudicated data, and per protocol, excluded silent MI. Overall, 1,299 (610 ticagrelor, 689 clopidogrel) MIs reported by the CEC occurred during the trial. Of these, 1,097 (504 ticagrelor, 593 clopidogrel) contributed to the primary composite endpoint. Site investigators reported 1,198 (580 ticagrelor, 618 clopidogrel) MIs. Ticagrelor significantly reduced overall MI rates (12-month CEC-adjudicated Kaplan-Meier rates: 5.8% ticagrelor, 6.9% clopidogrel; hazard ratio [HR]: 0.84; 95% confidence interval [CI]: 0.75 to 0.95). Nonprocedural MI (HR: 0.86; 95% CI: 0.74 to 1.01) and MI related to percutaneous coronary intervention or stent thrombosis tended to be lower with ticagrelor. MIs related to coronary artery bypass graft surgery were few, but numerical excess was observed in patients assigned ticagrelor. Analyses of overall MIs using investigator-reported data showed similar results but did not reach statistical significance (HR: 0.88; 95% CI: 0.78 to 1.00). In patients with ACS, ticagrelor significantly reduced the incidence of MI compared with clopidogrel, with consistent results across most MI subtypes. CEC procedures identified more MI endpoints compared with site investigators. (A Comparison of Ticagrelor [AZD6140] and Clopidogrel in Patients With Acute Coronary Syndrome [PLATO]; NCT00391872). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  1. Impact of an automated email notification system for results of tests pending at discharge: a cluster-randomized controlled trial.

    Science.gov (United States)

    Dalal, Anuj K; Roy, Christopher L; Poon, Eric G; Williams, Deborah H; Nolido, Nyryan; Yoon, Cathy; Budris, Jonas; Gandhi, Tejal; Bates, David W; Schnipper, Jeffrey L

    2014-01-01

    Physician awareness of the results of tests pending at discharge (TPADs) is poor. We developed an automated system that notifies responsible physicians of TPAD results via secure, network email. We sought to evaluate the impact of this system on self-reported awareness of TPAD results by responsible physicians, a necessary intermediary step to improve management of TPAD results. We conducted a cluster-randomized controlled trial at a major hospital affiliated with an integrated healthcare delivery network in Boston, Massachusetts. Adult patients with TPADs who were discharged from inpatient general medicine and cardiology services were assigned to the intervention or usual care arm if their inpatient attending physician and primary care physician (PCP) were both randomized to the same study arm. Patients of physicians randomized to discordant study arms were excluded. We surveyed these physicians 72 h after all TPAD results were finalized. The primary outcome was awareness of TPAD results by attending physicians. Secondary outcomes included awareness of TPAD results by PCPs, awareness of actionable TPAD results, and provider satisfaction. We analyzed data on 441 patients. We sent 441 surveys to attending physicians and 353 surveys to PCPs and received 275 and 152 responses from 83 different attending physicians and 112 different PCPs, respectively (attending physician survey response rate of 63%). Intervention attending physicians and PCPs were significantly more aware of TPAD results (76% vs 38%, adjusted/clustered OR 6.30 (95% CI 3.02 to 13.16), pemail notification represents a promising strategy for managing TPAD results, potentially mitigating an unresolved patient safety concern. ClinicalTrials.gov (NCT01153451).

  2. Reporting of Randomized Controlled Trials With Statistically Nonsignificant Primary Outcomes Published in High-impact Surgical Journals.

    Science.gov (United States)

    Arunachalam, Lakshmanan; Hunter, Iain A; Killeen, Shane

    2017-06-01

    To determine the nature and frequency of distorted presentation or "spin" (ie, specific reporting strategies which highlight that the experimental treatment is beneficial, despite a statistically nonsignificant difference for the primary outcome, or distract the reader from statistically nonsignificant results) in published reports of randomized controlled trials (RCTs) with statistically nonsignificant results for primary outcomes in surgical journals. Multiple reports have suggested that interpretation of RCT results in medical journals can be distorted by authors of published reports. Using a defined search strategy, RCTs with clearly nonsignificant results for the primary outcome (P > 0.05) form 10 high-impact factor surgical journals (Annals of Surgery, Journal of Neurology, Neurosurgery and Psychiatry, Journal of Heart and Lung Transplantation, American Journal of Transplantation, British Journal of Surgery, Journal of Bone and Joint Surgery, Journal of the American College of Surgeons, Endoscopy, Archives of Surgery, and Liver transplantation), published between July 2013 to July 2015, were identified. Two reviewers independently appraised each selected article using a validated, standardized data abstraction form. In all, 110 eligible RCTs with nonsignificant primary outcomes were appraised. The title was reported with spin in 8 (7%) articles. Forty-four (40%) included abstracts and 39 (35%) main texts were classified as having spin in at least 1 section. The level of spin was high in 16 (14%) abstract and 19 (19%) main-text "Conclusions" sections. Twenty-five articles (23%) recommended the intervention of interest despite a nonsignificant primary outcome. There was no relationship between trial funding source, use of statistician and article section, and the presence of spin. In RCTs with statistically nonsignificant primary outcomes published in surgical journals, the reporting and interpretation of findings was frequently inconsistent with the results.

  3. Environmental constraints and call evolution in torrent-dwelling frogs.

    Science.gov (United States)

    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.

  4. Patient-reported Outcomes in Randomised Controlled Trials of Prostate Cancer: Methodological Quality and Impact on Clinical Decision Making

    Science.gov (United States)

    Efficace, Fabio; Feuerstein, Michael; Fayers, Peter; Cafaro, Valentina; Eastham, James; Pusic, Andrea; Blazeby, Jane

    2014-01-01

    Context Patient-reported outcomes (PRO) data from randomised controlled trials (RCTs) are increasingly used to inform patient-centred care as well as clinical and health policy decisions. Objective The main objective of this study was to investigate the methodological quality of PRO assessment in RCTs of prostate cancer (PCa) and to estimate the likely impact of these studies on clinical decision making. Evidence acquisition A systematic literature search of studies was undertaken on main electronic databases to retrieve articles published between January 2004 and March 2012. RCTs were evaluated on a predetermined extraction form, including (1) basic trial demographics and clinical and PRO characteristics; (2) level of PRO reporting based on the recently published recommendations by the International Society for Quality of Life Research; and (3) bias, assessed using the Cochrane Risk of Bias tool. Studies were systematically analysed to evaluate their relevance for supporting clinical decision making. Evidence synthesis Sixty-five RCTs enrolling a total of 22 071 patients were evaluated, with 31 (48%) in patients with nonmetastatic disease. When a PRO difference between treatments was found, it related in most cases to symptoms only (n = 29, 58%). Although the extent of missing data was generally documented (72% of RCTs), few reported details on statistical handling of this data (18%) and reasons for dropout (35%). Improvements in key methodological aspects over time were found. Thirteen (20%) RCTs were judged as likely to be robust in informing clinical decision making. Higher-quality PRO studies were generally associated with those RCTs that had higher internal validity. Conclusions Including PRO in RCTs of PCa patients is critical for better evaluating the treatment effectiveness of new therapeutic approaches. Marked improvements in PRO quality reporting over time were found, and it is estimated that at least one-fifth of PRO RCTs have provided sufficient

  5. Impact of dexmedetomidine on the incidence of delirium in elderly patients after cardiac surgery: A randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Xue Li

    Full Text Available Delirium is a frequent complication after cardiac surgery and its occurrence is associated with poor outcomes. The purpose of this study was to investigate the impact of perioperative dexmedetomidine administration on the incidence of delirium in elderly patients after cardiac surgery.This randomized, double-blinded, and placebo-controlled trial was conducted in two tertiary hospitals in Beijing between December 1, 2014 and July 19, 2015. Eligible patients were randomized into two groups. Dexmedetomidine (DEX was administered during anesthesia and early postoperative period for patients in the DEX group, whereas normal saline was administered in the same rate for the same duration for patients in the control (CTRL group. The primary endpoint was the incidence of delirium during the first five days after surgery. Secondary endpoints included the cognitive function assessed on postoperative days 6 and 30, the overall incidence of non-delirium complications within 30 days after surgery, and the all-cause 30-day mortality.Two hundred eighty-five patients were enrolled and randomized. Dexmedetomidine did not decrease the incidence of delirium (4.9% [7/142] in the DEX group vs 7.7% [11/143] in the CTRL group; OR 0.62, 95% CI 0.23 to 1.65, p = 0.341. Secondary endpoints were similar between the two groups; however, the incidence of pulmonary complications was slightly decreased (OR 0.51, 95% CI 0.26 to 1.00, p = 0.050 and the percentage of early extubation was significantly increased (OR 3.32, 95% CI 1.36 to 8.08, p = 0.008 in the DEX group. Dexmedetomidine decreased the required treatment for intraoperative tachycardia (21.1% [30/142] in the DEX group vs 33.6% [48/143] in the CTRL group, p = 0.019, but increased the required treatment for postoperative hypotension (84.5% [120/142] in the DEX group vs 69.9% [100/143] in the CTRL group, p = 0.003.Dexmedetomidine administered during anesthesia and early postoperative period did not decrease the incidence

  6. 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

  7. 78 FR 76257 - Rural Call Completion

    Science.gov (United States)

    2013-12-17

    ... such service offers the capability to place calls to or receive calls from the PSTN. 6. In addition... traffic in response to continued complaints about rural call completion issues from rural associations... Project offering providers the opportunity to test call completion issues identified on calls destined to...

  8. A comprehensive evaluation of the impact of telemonitoring in patients with long-term conditions and social care needs: protocol for the whole systems demonstrator cluster randomised trial

    Directory of Open Access Journals (Sweden)

    Bower Peter

    2011-08-01

    Full Text Available Abstract Background It is expected that increased demands on services will result from expanding numbers of older people with long-term conditions and social care needs. There is significant interest in the potential for technology to reduce utilisation of health services in these patient populations, including telecare (the remote, automatic and passive monitoring of changes in an individual's condition or lifestyle and telehealth (the remote exchange of data between a patient and health care professional. The potential of telehealth and telecare technology to improve care and reduce costs is limited by a lack of rigorous evidence of actual impact. Methods/Design We are conducting a large scale, multi-site study of the implementation, impact and acceptability of these new technologies. A major part of the evaluation is a cluster-randomised controlled trial of telehealth and telecare versus usual care in patients with long-term conditions or social care needs. The trial involves a number of outcomes, including health care utilisation and quality of life. We describe the broad evaluation and the methods of the cluster randomised trial Discussion If telehealth and telecare technology proves effective, it will provide additional options for health services worldwide to deliver care for populations with high levels of need. Trial Registration Current Controlled Trials ISRCTN43002091

  9. The FDA outlook of events reporting after ticagrelor or clopidogrel in the PLATO Trial: impact of sponsor censoring dates, drug discontinuation, and withdrawal of consent.

    Science.gov (United States)

    Serebruany, Victor L

    2011-01-01

    Censoring by the study sponsor of clinical endpoint events in indication-seeking randomized trials represents a controversial approach since the reported data may be biased in favor of experimental agents due to the obvious conflict of interest. The frequency of drug discontinuation and rates of consent withdrawal may also impact the trial outcomes. To assess patterns of event reporting dependent on sponsor censoring dates, drug discontinuation and consent withdrawal in the PLATO trial. Analysis of the Food and Drug Administration Complete Response Review for ticagrelor. Excluding adjudicated deaths, the distribution for clopidogrel appears more uniform while that for ticagrelor was skewed to the right, suggesting more events were reported after the sponsor censoring end date. PLATO investigators reported 16 unmatched primary endpoint events for ticagrelor immediately following the sponsor censoring date. Twenty-six out of 30 unreported events following early drug discontinuation occurred amongst patients using ticagrelor. More ticagrelor patients withdrew consent (Δ = 47), or were 'not willing' to complete the study (Δ = 87) when compared to clopidogrel. Site-reported primary endpoints were unequally distributed for clopidogrel and ticagrelor in the PLATO trial. This pattern suggests the importance of questioning the impact of sponsor-mediated censoring on event reporting by investigators in indication-seeking trials. In PLATO, this pattern seems to have favored the experimental drug and may require further assessment. Copyright © 2012 S. Karger AG, Basel.

  10. Impact of balanced tetrastarch raw material on perioperative blood loss: a randomized double blind controlled trial.

    Science.gov (United States)

    Joosten, A; Tircoveanu, R; Arend, S; Wauthy, P; Gottignies, P; Van der Linden, P

    2016-10-01

    As 6% hydroxyethyl starch (HES) 130/0.40 or 130/0.42 can originate from different vegetable sources, they might have different clinical effects. The purpose of this prospective, randomized, double-blind controlled trial was to compare two balanced tetrastarch solutions, one maize-derived and one potato-derived, on perioperative blood loss in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB). We randomly assigned 118 patients undergoing elective cardiac surgery into two groups, to receive either a maize- or a potato-derived HES solution. Study fluids were administered perioperatively (including priming of CPB) until the second postoperative day (POD#2) using a goal directed algorithm. The primary outcome was calculated postoperative blood loss up to POD#2. Secondary outcomes included short-term incidence of acute kidney injury (AKI), and long-term effect (up to one yr) on renal function. Preoperative and intraoperative characteristics of the subjects were similar between groups. Similar volumes of HES were administered (1950 ml [1250-2325] for maize-HES and 2000 ml [1500-2700] for potato-HES; P=0.204). Calculated blood loss (504 ml [413-672] for maize-HES vs 530 ml [468-705] for potato-HES; P=0.107) and the need for blood components were not different between groups. The incidence of AKI was similar in both groups (P=0.111). Plasma creatinine concentration and glomerular filtration rates did vary over time, although changes were minimal. Under our study conditions, HES 130/0.4 or 130/0.42 raw material did not have a significant influence on perioperative blood loss. Moreover, we did not find any effect of tetrastarch raw material composition on short and long-term renal function. EudraCT number: 2011-005920-16. © The Author 2016. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  11. Impact of Renal Function on Outcomes With Edoxaban in the ENGAGE AF-TIMI 48 Trial.

    Science.gov (United States)

    Bohula, Erin A; Giugliano, Robert P; Ruff, Christian T; Kuder, Julia F; Murphy, Sabina A; Antman, Elliott M; Braunwald, Eugene

    2016-07-05

    Edoxaban, an oral factor Xa inhibitor with 50% renal clearance, was noninferior to well-managed warfarin for stroke or systemic embolism (S/SE) prevention and reduced bleeding in patients with atrial fibrillation. We evaluated the efficacy and safety of edoxaban versus warfarin across the range of baseline creatinine clearance (CrCl) in the ENGAGE AF-TIMI 48 trial (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction Study 48) with a focus on the higher-dose edoxaban regimen (HDER) and the upper range of CrCl. A total of 14 071 patients with atrial fibrillation at moderate to high risk for stroke were randomized to warfarin or HDER (60 mg daily or a 50% dose reduction to 30 mg daily for CrCl 30-50 mL/min, body weight of ≤60 kg, or use of a potent phosphorylated glycoprotein inhibitor). CrCl 50 mL/min (hazard ratio [HR], 0.87; 95% confidence interval [CI], 0.72-1.04) was similar to that in patients with CrCl ≤50 mL/min (HR, 0.87; 95% CI, 0.65-1.18; P for interaction=0.94). Several exploratory analyses suggested lower relative efficacy for the prevention of S/SE with HDER compared with warfarin at higher levels of CrCl (CrCl ≤50 mL/min: HR, 0.87; 95% CI, 0.65-1.18; CrCl >50-95 mL/min: HR, 0.78; 95% CI, 0.64-0.96; CrCl >95 mL/min: HR, 1.36; 95% CI, 0.88-2.10; P for interaction=0.08). Bleeding rates were lower at all levels of CrCl with HDER (P for interaction=0.11). Because of the preserved effect on bleeding, the net clinical outcome was more favorable with HDER across the range of CrCl (P for interaction=0.73). Similar findings were observed in the sensitivity analysis using the CKD-EPI formula. Although there was an apparent decrease in relative efficacy to prevent arterial thromboembolism in the upper range of CrCl, the safety and net clinical benefit of HDER compared with warfarin are consistent across the range of renal function. URL: http://www.clinicaltrials.gov. Unique identifier: NCT

  12. Climbing Has a Positive Impact on Low Back Pain: A Prospective Randomized Controlled Trial.

    Science.gov (United States)

    Schinhan, Martina; Neubauer, Benedikt; Pieber, Karin; Gruber, Michael; Kainberger, Franz; Castellucci, Clara; Olischar, Boris; Maruna, Andrea; Windhager, Reinhard; Sabeti-Aschraf, Manuel

    2016-05-01

    Comparison of climbing versus no treatment to treat chronic low back pain. Prospective randomized controlled trial. Tertiary. A total of 30 patients with chronic low back pain were recruited and randomly assigned to 2 different groups: climbing and control. The inclusion criteria were defined as chronic low back pain, age between 18 and 45 years, body mass index lower than 25, and no climbing experience. Patients in the climbing group were instructed to climb 5 different climbing routes. A climbing activity of 10 sessions in 8 weeks, at least once a week with a minimum duration of 1 hour, was mandatory. The participants were examined before (T0) and after therapy (8 weeks, T8) and after another 6 weeks (T14). The outcome was evaluated using Oswestry Disability Index, Visual Analog Scale (VAS), Likert scale, and magnetic resonance imaging (MRI). Radiologists evaluating MRI were blinded. The study was performed as a single-center study. Evaluating the Oswestry Disability Index, a significant difference in the time course between the 2 groups was detected (P = 0.022). Significant improvements comparing climbing and control group were also found when assessing VAS in a minimal finger-floor-distance position (P = 0.048). Patients in the climbing group showed a reduction in size of disc protrusion. Climbing may be an effective and low-cost therapy option for people with chronic low back pain. Low back pain is a very common disease but still a challenge to treat. Therapy strategies vary from conservative ones, pharmacological treatment with non-steroidal anti-inflammatory drugs (NSAIDs) and weak opioids, to invasive treatment with acupuncture, injections, and operative reconstruction. Some can be costly and not without risks. For instance, many people who use NSAIDs are at risk of common side effects such as gastrointestinal complications (irritation, ulcers, and bleeding) that may lead to hospitalization. Climbing could offer reduction of pain and better performance in

  13. Impact of responsive insertion technology (RIT) on reducing discomfort during colonoscopy: randomized clinical trial.

    Science.gov (United States)

    Pasternak, Artur; Szura, Miroslaw; Solecki, Rafal; Matyja, Maciej; Szczepanik, Antoni; Matyja, Andrzej

    2017-05-01

    In many countries, colonoscopies for colorectal cancer screening are performed without sedation due to the cost. Changes in the structure of the endoscopes are designed to facilitate the colonoscopic examination, reduce the duration of the procedure, and improve the imaging of the intestinal lumen. The variable stiffness of the endoscope and the recently introduced responsive insertion technology (RIT) are features aimed at easing colonoscope insertion and reducing the discomfort and pain during the examination. The aim of the study is to analyze whether the new RIT system can improve the practice of colonoscopy under no anesthesia with respect to the widely available variable stiffness colonoscopes. This analysis included 647 patients who underwent complete colonoscopy in the screening program. All colonoscopies were performed without sedation. Olympus series 180 and 190 endoscopes equipped with a magnetic positioning system were used. Group I included patients who were examined using endoscopes equipped with responsive insertion technology (RIT), and group II included patients who were examined using conventional variable stiffness colonoscopies. The main objective was to evaluate the cecal intubation time, the number of loops, the requirement to apply manual pressure to different areas of the abdomen and the degree of discomfort and pain expressed on a visual analogue scale (VAS). ClinicalTrials.gov number, NCT01688557. Group I consisted of 329 patients, and group II included 318 patients. The mean age of the patients was 58.4 years (SD ± 4.21). Both groups were compared in terms of age, sex, and BMI. The mean cecal intubation time was 209 s in group I and 224 s in group II (p < 0.05). Increased loop formation was observed upon endoscope insertion in group II (1.7 vs. 1.35) (p < 0.05) and required more manual pressure to the abdomen (2.2 vs. 1.7) (p = 0.001). In group I, less discomfort and pain, as graded on a VAS (2.3 vs. 2.6), were noted. The

  14. Impact of cardiac rehabilitation on peripheral circulation as assessed by impedance plethysmography: a randomized clinical trial.

    Science.gov (United States)

    Jurczak, I; Kowalski, J; Irzmański, R

    2014-12-01

    It's known, controlled physical exercise which is a part of cardiac rehabilitation lead to positive changes in coronary circulation and contributes to minimizing other risk factors, such as lipid concentration in the blood or body weight as well as decreases the risk of another acute coronary disease. Monitoring cardiovascular activity is a necessary element of supervising the patient during cardiac rehabilitation. This supervision is primarily concerned with coronary circulation, bypassing the peripheral circulation which may seem like an important part of properly reacts to physical activity. The aim of the study was to evaluate changes in the peripheral circulation in the calf, induced by controlled physical exercise performed within a standard rehabilitation procedure in patients with acute coronary disease, with the use of impedance plethysmography. Clinical trial (CT). All the patients were referred to be cardiologically rehabilitated to the hospital in the Clinic of Internal Diseases and Cardiological Rehabilitation of the Medical University of Łodz not later than one month following the occurrence of acute coronary disease. Forty-seven patients with acute coronary disease were divided into two study groups. Group I (N.=23) participated in a two-week and Group II in a four-week cardiac rehabilitation. Forty-seven patients participated in interval training on a cycle ergometer and exercise improving general physical state held five times a week. All the patients underwent impedance plethysmography test before and after the training session in order to evaluate peripheral circulation in lower limbs. The authors of the study observed changes in plethysmographic parameters. After two weeks of performing physical exercise Group I demonstrated an increase in the following parameters: PSlope by 3.8%, PAmpl by 1.7%, CT by 3.3% and PT by 1% (p>0.05). With regards to Group II, the parameters increased respectively by: 23.8% (PSlope), 20.4% (PAmpl), 11.6% (CT) and 6

  15. LOST to follow-up Information in Trials (LOST-IT: a protocol on the potential impact

    Directory of Open Access Journals (Sweden)

    Salazar Arturo

    2009-06-01

    Full Text Available Abstract Background Incomplete ascertainment of outcomes in randomized controlled trials (RCTs is likely to bias final study results if reasons for unavailability of patient data are associated with the outcome of interest. The primary objective of this study is to assess the potential impact of loss to follow-up on the estimates of treatment effect. The secondary objectives are to describe, for published RCTs, (1 the reporting of loss to follow-up information, (2 the analytic methods used for handling loss to follow-up information, and (3 the extent of reported loss to follow-up. Methods We will conduct a systematic review of reports of RCTs recently published in five top general medical journals. Eligible RCTs will demonstrate statistically significant effect estimates with respect to primary outcomes that are patient-important and expressed as binary data. Teams of 2 reviewers will independently determine eligibility and extract relevant information from each eligible trial using standardized, pre-piloted forms. To assess the potential impact of loss to follow-up on the estimates of treatment effect we will, for varying assumptions about the outcomes of participants lost to follow-up (LTFU, calculate (1 the percentage of RCTs that lose statistical significance and (2 the mean change in effect estimate across RCTs. The different assumptions we will test are the following: (1 none of the LTFU participants had the event; (2 all LTFU participants had the event; (3 all LTFU participants in the treatment group had the event; none of those in the control group had it (worst case scenario; (4 the event incidence among LTFU participants (relative to observed participants increased, with a higher relative increase in the intervention group; and (5 the event incidence among LTFU participants (relative to observed participants increased in the intervention group and decreased in the control group. Discussion We aim to make our objectives and methods

  16. Assessing the Health Impact of Water Quality Interventions in Low-Income Settings: Concerns Associated with Blinded Trials and the Need for Objective Outcomes.

    Science.gov (United States)

    Clasen, Thomas; Boisson, Sophie

    2016-07-01

    A dramatic disparity between the results of blinded versus open trial designs has raised questions about the effectiveness of water quality interventions and other environmental interventions to prevent diarrhea, a leading killer of young children in low-income countries. We summarize the results of blinded versus open trials of water quality interventions, describe evidence from a recent placebo-controlled trial in India suggesting that control households were put at risk from their participation, and suggest alternatives to blinded trials that could resolve continued uncertainty about the magnitude of the protective effect of water, sanitation, and hygiene (WASH) interventions without presenting ethical questions. Concerns about reporting bias in open trial designs continue to cause uncertainty about the effectiveness of WASH interventions. However, evidence suggests that despite instructions to the contrary, placebos may encourage control group participants in blinded trials to cease practicing traditional water treatment practices in the mistaken belief that they are protected by an active intervention. Although objective outcomes such as pathogen incrimination, seroconversion, biomarkers, and anthropometry can be helpful, these are often costly, nonspecific, and unsuitable for evaluating programmatic interventions. Unless researchers can be assured that a placebo will not cause those in a control group to change their behavior in a manner that increases their risk, it is incumbent on researchers to use alternatives. Validated objective measures are needed for assessing the health impact of WASH interventions that are reliable, affordable, and suitable both for research and program evaluation. Clasen T, Boisson S. 2016. Assessing the health impact of water quality interventions in low-income settings: concerns associated with blinded trials and the need for objective outcomes. Environ Health Perspect 124:886-889; http://dx.doi.org/10.1289/ehp.1510532.

  17. Clinical trials of cancer screening in the developing world and their impact on cancer healthcare.

    Science.gov (United States)

    Sankaranarayanan, R; Sauvaget, C; Ramadas, K; Ngoma, T; Teguete, I; Muwonge, R; Naud, P; Nessa, A; Kuhaprema, T; Qiao, Y

    2011-11-01

    Several research and training initiatives were organized by the International Agency for Research on Cancer (IARC) in collaboration with national institutions in countries such as Angola, Brazil, Burkina Faso, China, Republic of Congo, Guinea, India, Mali, Mauritania, Nepal, Niger, Peru, Tanzania and Thailand among others, to address feasible and effective means of early detection and prevention of cervical, breast and oral cancers. The impact of these activities, that involved over 600 000 participants and more than 1200 healthcare personnel trained on strengthening the local health services in terms of infrastructure, human resources and service delivery aspects in host countries and other regions, is addressed here. These studies, inbuilt in appropriate health services platforms, have resulted in the development and sustenance of several continuing point of care services of screening and treatment in most host countries, particularly in sub-Saharan Africa, and have catalysed regional early detection programmes in India, China and Thailand. The IARC collaborative studies have evolved into major focal points of training and extending services in many countries. The large evidence base, resulting from ours and other studies is likely, in due course, to facilitate much wider scaling up of screening and treatment services through organised programmes.

  18. Kindness in the blood: A randomized controlled trial of the gene regulatory impact of prosocial behavior.

    Science.gov (United States)

    Nelson-Coffey, S Katherine; Fritz, Megan M; Lyubomirsky, Sonja; Cole, Steve W

    2017-07-01

    Prosocial behavior is linked to longevity, but few studies have experimentally manipulated prosocial behavior to identify the causal mechanisms underlying this association. One possible mediating pathway involves changes in gene expression that may subsequently influence disease development or resistance. In the current study, we examined changes in a leukocyte gene expression profile known as the Conserved Transcriptional Response to Adversity (CTRA) in 159 adults who were randomly assigned for 4 weeks to engage in prosocial behavior directed towards specific others, prosocial behavior directed towards the world in general, self-focused kindness, or a neutral control task. Those randomized to prosocial behavior towards specific others demonstrated improvements (i.e., reductions) in leukocyte expression of CTRA indicator genes. No significant changes in CTRA gene expression were observed in the other 3 conditions. These findings suggest that prosocial behavior can causally impact leukocyte gene expression profiles in ways that might potentially help explain the previously observed health advantages associated with social ties. Copyright © 2017 Elsevier Ltd. All rights reserved.

  19. The impact of exercise during pregnancy on neonatal outcomes: a randomized controlled trial.

    Science.gov (United States)

    Murtezani, A; Paçarada, M; Ibraimi, Z; Nevzati, A; Abazi, N

    2014-12-01

    The effect of exercise training during the course of pregnancy on the newborn's birth weight is unclear. This study examines the effect of aerobic and strength conditioning exercise performed during the second and the third trimester of pregnancy in nulliparous, previously inactive women on the newborn's outcome. Sixty-three nulliparous, previously sedentary, were randomly assigned to either an exercise (N.=30) or a control (N.=33) group. The subjects participated in the exercise group (EG) focused on aerobic and strength-conditioning exercise in three sessions for about 20 weeks. We registered the birth weight, birth length, gestational age at time of delivery, Apgar score and head circumference of the newborn. There were no statistically significant differences between the two groups in mean birth weight, length, head circumference, and length of gestation. There was a significant difference between two groups in Apgar scores at 1 min (P=0.036) and 5 min (P=0.015) with newborns of the EG scoring higher than the CG. Supervised, aerobic and strength conditioning exercise performed over the second and third trimester of pregnancy does not have a negative impact on the newborn's body size and health.

  20. The impact of alcohol use severity on anxiety treatment outcomes in a large effectiveness trial in primary care.

    Science.gov (United States)

    Wolitzky-Taylor, Kate; Brown, Lily A; Roy-Byrne, Peter; Sherbourne, Cathy; Stein, Murray B; Sullivan, Greer; Bystritsky, Alexander; Craske, Michelle G

    2015-03-01

    The presence of anxiety disorders is associated with poorer alcohol use disorder treatment outcomes, but little is known about the impact of alcohol use problems on anxiety disorder treatment outcomes despite their high comorbidity. The current study examined the impact of alcohol use symptom severity on anxiety disorder treatment outcomes in a multi-site primary care effectiveness study of anxiety disorder treatment. Data came from the Coordinated Anxiety Learning and Management (CALM) effectiveness trial. Participants (N=1004) were randomized to an evidence-based anxiety intervention (including cognitive behavioral therapy and medications) or usual care in primary care. Participants completed measures of alcohol use, anxiety, and depression at baseline, 6-, 12-, and 18-month follow-up periods. Patients with alcohol dependence were excluded. There were no significant moderating (Treatment Group × Alcohol Use Severity) interactions. The majority of analyses revealed no predictive effects of alcohol use severity on outcome; however, alcohol problems at baseline were associated with somewhat higher anxiety and depression symptoms at the 18-month follow-up. These data indicate that patients with alcohol problems in primary care can be effectively treated for anxiety disorders. Baseline alcohol problems were associated with some poorer long-term outcomes, but this was evident across CALM and usual care. These findings provide preliminary evidence that there may be no need to postpone treatment of anxiety disorders until alcohol problems are addressed, at least among those who have mild to moderate alcohol problems. Replication with more severe alcohol use disorders is needed. Copyright © 2015 Elsevier Ltd. All rights reserved.

  1. The impact of immediate reporting on interpretive discrepancies and patient referral pathways within the emergency department: a randomised controlled trial.

    Science.gov (United States)

    Hardy, M; Snaith, B; Scally, A

    2013-01-01

    To determine whether an immediate reporting service for musculoskeletal trauma reduces interpretation errors and positively impacts on patient referral pathways. A pragmatic multicentre randomised controlled trial was undertaken. 1502 patients were recruited and randomly assigned to an immediate or delayed reporting arm and treated according to group assignment. Assessment was made of concordance in image interpretation between emergency department (ED) clinicians and radiology; discharge and referral pathways; and patient journey times. 1688 radiographic examinations were performed (1502 patients). 91 discordant interpretations were identified (n=91/1688; 5.4%) with a greater number of discordant interpretations noted in the delayed reporting arm (n=67/849, 7.9%). In the immediate reporting arm, the availability of a report reduced, but did not eliminate, discordance in interpretation (n=24/839, 2.9%). No significant difference in number of patients discharged, referred to hospital clinics or admitted was identified. However, patient ED recalls were significantly reduced (z=2.66; p=0.008) in the immediate reporting arm, as were the number of short-term inpatient bed days (5 days or less) (z=3.636; pjourney time from ED arrival to discharge or admission was equivalent (z=0.79, p=0.432). Immediate reporting significantly reduced ED interpretive errors and prevented errors that would require patient recall. However, immediate reporting did not eliminate ED interpretative errors or change the number of patients discharged, referred to hospital clinics or admitted overall. This is the first study to consider the wider impact of immediate reporting on the ED patient pathway as a whole and hospital resource usage.

  2. Ventilatory function during exercise in multiple sclerosis and impact of training intervention: cross-sectional and randomized controlled trial.

    Science.gov (United States)

    Hansen, D; Wens, I; Keytsman, C; Verboven, K; Dendale, P; Eijnde, B O

    2015-10-01

    Patients with MS (pwMS) often experience resting ventilatory anomalies. Ventilatory function during exercise and impact of long-term training intervention remains however uncertain. The aim of this study was to examine the ventilatory function during exercise and impact of a 6-month training intervention in pwMS. Combination of a cross-sectional (part 1) and randomized controlled trial (part 2). University rehabilitation facility. Caucasian patients with MS and healthy controls. In part 1, the ventilatory function during submaximal endurance exercise was compared between pwMS (N.=37) and healthy participants (N.=15). In part 2, pwMS were then randomly assigned to a 6-month training intervention (N.=16) or usual care (N.=11). Following training intervention, ventilatory function during exercise was re-evaluated. Despite comparable relative exercise testing intensities between groups in part 1, significantly elevated steady-state exercise dead space/tidal volume ratio, O2 uptake and CO2 output equivalent, end-tidal O2 pressure, ratings of perceived exertion and lowered end-tidal CO2 pressure and O2 pulse was observed in pwMS (Ptraining intervention, ventilatory dysfunction remained present during endurance exercise (P>0.05). Patients with MS experience a ventilatory dysfunction during endurance exercise, which is related to worse exercise tolerance. This ventilatory anomaly remains present after long-term training intervention. Patients with MS experience ventilatory dysfunction during exercise. This dysfunction is related to exercise tolerance and ratings of perceived exertion. Long-term exercise training did not remediate this ventilatory dysfunction. The systematic examination of the pulmonary/cardiovascular system at rest and during exercise is recommended in MS.

  3. Impact of a multicomponent hand hygiene-related intervention on the infectious risk in nursing homes: A cluster randomized trial.

    Science.gov (United States)

    Temime, Laura; Cohen, Nadia; Ait-Bouziad, Karim; Denormandie, Philippe; Dab, William; Hocine, Mounia N

    2017-10-05

    The aim of this study was to assess the impact of a multifaceted hand hygiene (HH) program on the infectious risk in nursing homes (NHs). This was a 2-arm cluster randomized trial; French NHs were allocated randomly to the intervention (13 NHs) or control (13 NHs) groups. The intervention consisted of implementing a bundle of HH-related measures over 1 year, including increased availability of alcohol-based handrub, HH promotion, staff education, and local work groups. The primary end point was the incidence rate of acute respiratory infections and gastroenteritis reported in the context of clustered cases episodes. Secondary end points were mortality, hospitalization, and antibiotic prescription rates. Baseline characteristics did not differ between groups. The overall handrub consumption was higher in the intervention group over the 1-year intervention period. Because of underreporting, data on the primary end points were of insufficient quality for analysis. Hospitalizations did not differ between the 2 groups. However, the intervention group showed significantly lower mortality (2.10 vs 2.65 per 100 residents per month, respectively; P = .003) and antibiotic prescriptions (5.0 vs 5.8 defined daily doses per 100 resident days, respectively; P < .001). These results were confirmed by the longitudinal multivariate analysis adjusted for NH and resident characteristics and for seasonality (mortality rate ratio, 0.76). A multifaceted HH intervention may have a short-term impact on mortality in NHs. Nevertheless, other strategies may remain necessary to reduce morbidity. Copyright © 2017 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

  4. Prognostic impact of metabolic syndrome in patients with chronic heart failure: data from GISSI-HF trial.

    Science.gov (United States)

    Perrone-Filardi, Pasquale; Savarese, Gianluigi; Scarano, Marco; Cavazzina, Riccardo; Trimarco, Bruno; Minneci, Sergio; Maggioni, Aldo Pietro; Tavazzi, Luigi; Tognoni, Gianni; Marchioli, Roberto

    2015-01-15

    The adverse prognostic impact of metabolic syndrome (METS) in unselected populations and in patients with coronary heart disease has been previously shown. The aim of the current analysis was to evaluate the impact of METS on prognosis in chronic heart failure (HF). International Diabetes Federation criteria were used for the diagnosis of METS. Adjusted Cox regression models with all-cause and HF death as outcomes were fitted in 6648 patients enrolled in GISSI-HF trial with no missing values for the variables of interest. Risk of all-cause and HF death was significantly reduced in patients with METS compared to patients without METS (HR: 0.83, 95% CI: 0.72 to 0.95, p=0.005; HR: 0.76, 95% CI: 0.59 to 0.98, p=0.031; respectively). As compared with patients with no METS and no type 2 diabetes mellitus (DM), the risk of all-cause and HF death was significantly lower in patients with METS and no DM (HR: 0.76, 95% CI: 0.62 to 0.95, p=0.015; HR: 0.65, 95% CI: 0.42 to 0.99, p=0.046; respectively), whereas it was significantly increased in patients with DM and no METS (HR: 1.34, 95% CI: 1.21 to 1.48, pHF death compared with patients with no METS and no DM (HR: 1.03, 95% CI: 0.87 to 1.21, p=0.762; HR: 0.99; 95% CI: 0.73 to 1.35; p=0.963; respectively). METS is associated with reduced all-cause and HF mortality in patients with HF. HF patients with DM without METS are at the highest risk of mortality, whereas METS attenuates mortality risk in HF patients with DM. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  5. The Impact of Rudeness on Medical Team Performance: A Randomized Trial.

    Science.gov (United States)

    Riskin, Arieh; Erez, Amir; Foulk, Trevor A; Kugelman, Amir; Gover, Ayala; Shoris, Irit; Riskin, Kinneret S; Bamberger, Peter A

    2015-09-01

    Iatrogenesis often results from performance deficiencies among medical team members. Team-targeted rudeness may underlie such performance deficiencies, with individuals exposed to rude behavior being less helpful and cooperative. Our objective was to explore the impact of rudeness on the performance of medical teams. Twenty-four NICU teams participated in a training simulation involving a preterm infant whose condition acutely deteriorated due to necrotizing enterocolitis. Participants were informed that a foreign expert on team reflexivity in medicine would observe them. Teams were randomly assigned to either exposure to rudeness (in which the expert's comments included mildly rude statements completely unrelated to the teams' performance) or control (neutral comments). The videotaped simulation sessions were evaluated by 3 independent judges (blinded to team exposure) who used structured questionnaires to assess team performance, information-sharing, and help-seeking. The composite diagnostic and procedural performance scores were lower for members of teams exposed to rudeness than to members of the control teams (2.6 vs 3.2 [P = .005] and 2.8 vs 3.3 [P = .008], respectively). Rudeness alone explained nearly 12% of the variance in diagnostic and procedural performance. A model specifying information-sharing and help-seeking as mediators linking rudeness to team performance explained an even greater portion of the variance in diagnostic and procedural performance (R(2) = 52.3 and 42.7, respectively). Rudeness had adverse consequences on the diagnostic and procedural performance of the NICU team members. Information-sharing mediated the adverse effect of rudeness on diagnostic performance, and help-seeking mediated the effect of rudeness on procedural performance. Copyright © 2015 by the American Academy of Pediatrics.

  6. Randomised trial of impact of school mental-health programme in rural Rawalpindi, Pakistan.

    Science.gov (United States)

    Rahman, A; Mubbashar, M H; Gater, R; Goldberg, D

    1998-09-26

    A school mental-health programme has been developed as a component of the community mental-health programme in Rawalpindi, Pakistan. It has the objective of improving the understanding of disorders of mental health in the rural community. We aimed to assess the impact of a school mental-health programme on the awareness of schoolchildren, their parents, friends who were not attending school, and neighbours. We chose two secondary schools for boys and two for girls that were similar in terms of size, staff-pupil ratio, and drop-out rates. 100 children aged 12-16 years (25 girls and 25 boys in each of the study and control groups), 100 parents (one for each child), 100 friends who did not attend school (one for each child), and 100 neighbours (one for each child) were given a 19-item questionnaire before and after the study group had had a 4-month programme of mental-health education. The maximum score for the questionnaire was 16 points. Before the school mental-health programme the awareness of mental-health issues was poor (mean score 5.7-7.6) in the four groups of participants. In the study group there was a significant improvement in the mean scores after the school programme in the schoolchildren (mean improvement 7.6 [95% CI 6.7-8.5], pschool programme succeeded in improving awareness of mental health in schoolchildren and the community. The schoolchildren were receptive to the programme, and shared their new understanding with family, friends, and neighbours. Mental-health planners who wish to improve community awareness of mental health, particularly in areas with low literacy rates, should consider setting up school mental-health programmes.

  7. Anchor Trial Launch

    Science.gov (United States)

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

  8. 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

  9. Impact of insertion torque and implant neck design on peri-implant bone level: a randomized split-mouth trial.

    Science.gov (United States)

    Hof, Markus; Pommer, Bernhard; Strbac, Georg D; Vasak, Christoph; Agis, Hermann; Zechner, Werner

    2014-10-01

    The aim of this study is to assess the impact of insertion torque and implant neck design on peri-implant bone levels and gain insights into dynamic crestal tissue alterations by radiological, clinical, and biochemical examinations. In this prospective trial, a total of 84 implants (four implants in each patient) in the interforaminal region of 21 edentulous mandibles were randomly alternated according to a split-mouth design. Implant placement was performed using different insertion torques (≤20 Ncm vs >50 Ncm). In each group, one machined and one anodized implant neck design (1.5 mm length) was used in the same jaw side. Evaluation of peri-implant tissues involved radiological, clinical examination and immunoassays for interleukin-1β. No significant influence of insertion torque or implant neck design on peri-implant bone level was found. Protein levels of interleukin-1β in the peri-implant crevicular fluid revealed no difference between both insertion torque groups and different neck designs. Interactive effects of insertion torque and neck surface modification may exist; however, no clinically significant differences in marginal bone resorption after 1 year could be observed in the edentulous anterior mandible. © 2013 Wiley Periodicals, Inc.

  10. Components of family history associated with women's disease perceptions for cancer: A report from the Family Healthware™ Impact Trial

    Science.gov (United States)

    Rubinstein, Wendy S.; O'Neill, Suzanne M.; Rothrock, Nan; Starzyk, Erin J.; Beaumont, Jennifer L.; Acheson, Louise S.; Wang, Catharine; Gramling, Robert; Galliher, James M.; Ruffin, Mack T.

    2014-01-01

    Purpose To determine the specific components of family history and personal characteristics related to disease perceptions about breast, colon, and ovarian cancers. Methods Baseline, cross-sectional data on 2,505 healthy women aged 35–65 years enrolled from 41 primary care practices in the cluster-randomized Family Healthware™ Impact Trial, assessed for detailed family history and perceived risk, perceived severity, worry, and perceived control over getting six common diseases including breast, colon, and ovarian cancers. Results Participants provided family history information on 41,841 total relatives. We found evidence of underreporting of paternal family history and lower perceived breast cancer risk with cancer in the paternal versus maternal lineage. We observed cancer-specific perceived risks and worry for individual family history elements and also found novel “spillover” effects where a family history of one cancer was associated with altered disease perceptions of another. Having a mother with early-onset breast or ovarian cancer was strongly associated with perceived risk of breast cancer. Age, parenthood, and affected lineage were associated with disease perceptions and ran counter to empiric risks. Conclusions Understanding patients' formulation of risk for multiple diseases is important for public health initiatives that seek to inform risk appraisal, influence disease perceptions, or match preventive interventions to existing risk perceptions. PMID:21150785

  11. Does Topical Ozone Therapy Improve Patient Comfort After Surgical Removal of Impacted Mandibular Third Molar? A Randomized Controlled Trial.

    Science.gov (United States)

    Sivalingam, Varun P; Panneerselvam, Elavenil; Raja, Krishnakumar V B; Gopi, Gayathri

    2017-01-01

    To assess the influence of topical ozone administration on patient comfort after third molar surgery. A single-blinded randomized controlled clinical trial was designed involving patients who required removal of bilateral impacted mandibular third molars. The predictor variable was the postoperative medication used after third molar surgery. Using the split-mouth design, the study group received topical ozone without postoperative systemic antibiotics, whereas the control group did not receive ozone but only systemic antibiotics. The 2 groups were prescribed analgesics for 2 days. The assessing surgeon was blinded to treatment assignment. The primary outcome variables were postoperative mouth opening, pain, and swelling. The secondary outcome variable was the number of analgesic doses required by each group on postoperative days 3 to 5. Data analysis involved descriptive statistics, paired t tests, and 2-way analysis of variance with repeated measures (P ozone gel were observed in any patient. Ozone gel was found to be an effective topical agent that considerably improves patient comfort postoperatively and can be considered a substitute of postoperative systemic antibiotics. Copyright © 2016 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

  12. The Impact of the Project K Youth Development Program on Self-Efficacy: A Randomized Controlled Trial.

    Science.gov (United States)

    Deane, Kelsey L; Harré, Niki; Moore, Julie; Courtney, Matthew G R

    2017-03-01

    A key issue for youth development programs is whether the learning they provide is transferred to participants' daily lives. It is also important that they are effective for the diverse range of participants they attract. This study used a randomized controlled trial design to measure the impact of Project K, a New Zealand-based youth development program, on academic and social self-efficacy. Project K combines a 3-week wilderness adventure, a 10 day community service component, and 1 year of mentoring to promote positive growth in 14-15 year olds with low self-efficacy. At baseline, the evaluation included 600 Project K (46 % female) and 577 Control participants (48 % female) and revealed that Project K was effective in improving both social and academic self-efficacy from pre- to post-program with effects being sustained 1 year later. Parents' perceptions of changes in the participants' interpersonal skills supported these findings. Differential program effects were found across participant subgroups, particularly 1 year after program completion. The implications of these differences are discussed.

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

    Science.gov (United States)

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

    2010-05-01

    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. Copyright 2009 Elsevier Ltd. All rights reserved.

  14. A controlled trial of the impact of exposure to positive images of dentistry on anticipatory dental fear in children.

    Science.gov (United States)

    Fox, C; Newton, J T

    2006-12-01

    Dental anxiety is common in children. This study sought to determine the impact of viewing positive images of dentistry prior to a dental appointment on the anticipatory dental anxiety levels of children attending for dental treatment. Controlled trial. Assessment of anxiety and analysis of data were conducted blind to experimental condition. Assessment of anxiety was carried out in the waiting room postintervention but before the patient entered the dental surgery for treatment. Thirty-eight children and young adults attending a dental clinic in South West England. Participants were randomly assigned to one of two conditions. In both conditions the participant was asked to look at photographs for 2 min in the waiting area prior to their appointment. The intervention consisted of viewing positive images of dentistry and dental treatment, the control condition consisted of dentally neutral images. Positive and neutral images were validated independently by four paediatric dentists. The assessment of anticipatory dental anxiety was made blind to experimental condition and statistical analysis was conducted blind to group membership. Anticipatory anxiety assessed by the Venham Picture Test. A significant difference in anticipatory dental anxiety was found between the two groups (median-positive images = 0, median-neutral images = 3; P 0.05), there was no difference between male and female participants in their level of anticipatory anxiety (median-males = 0.5, median-females = 1 P > 0.05). Viewing positive images of dentistry and dentists results in short-term reductions in anticipatory anxiety in children.

  15. The Impact of Aloe vera and Calendula on Perineal Healing after Episiotomy in Primiparous Women: A Randomized Clinical Trial.

    Science.gov (United States)

    Eghdampour, Farideh; Jahdie, Fereshteh; Kheyrkhah, Masomeh; Taghizadeh, Mohsen; Naghizadeh, Somayeh; Hagani, Hamid

    2013-12-01

    Episiotomy is used for enlarging the perineum. Aloe vera and Calendula have been used for treating different diseases from ancient times, limited researches have been done regarding the healing of these plants. Since the effect of their ointment on episiotomy healing has not been studied, this study is being done for determining the impact of Aloe vera and Calendula on episiotomy healing in primiparous women. This clinical trial involves 111 qualified primiparous women admitted in Lolagar hospital. They were randomly categorized into three groups of control (n=1) and experimental (n=2) groups. The women in experimental group used Aloe vera and Calendula Ointment every 8 hours and the control group used hospital routine on episiotomy for 5 days. The data were collected by demographic questionnaire and redness, edema, ecchymosis, discharge and approximation scale (REEDA) which investigated the episiotomy healing before and five days after intervention in two groups. ANOVA, Tukey test, Kruskal-wallis, Chi-square were used for data analysis. The three groups do not have statistically significant different regarding demographic and other intervening variables. Comparing the mean of REEDA in five days after delivery showed statistically significant difference between control and experimental groups. According to the results, using Aloe vera and Calendula ointment considerably increases the speed of episiotomy wound healing so it can be used for quickening the episiotomy healing.

  16. The Impact of Aloe vera and Calendula on Perineal Healing after Episiotomy in Primiparous Women: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Farideh Eghdampour

    2013-11-01

    Full Text Available Introduction: Episiotomy is used for enlarging the perineum. Aloe vera and Calendula have been used for treating different diseases from ancient times, limited researches have been done regarding the healing of these plants. Since the effect of their ointment on episiotomy healing has not been studied, this study is being done for determining the impact of Aloe vera and Calendula on episiotomy healing in primiparous women. Methods: This clinical trial involves 111 qualified primiparous women admitted in Lolagar hospital. They were randomly categorized into three groups of control (n=1 and experimental (n=2 groups. The women in experimental group used Aloe vera and Calendula Ointment every 8 hours and the control group used hospital routine on episiotomy for 5 days. The data were collected by demographic questionnaire and redness, edema, ecchymosis, discharge and approximation scale (REEDA which investigated the episiotomy healing before and five days after intervention in two groups. ANOVA, Tukey test, Kruskal-wallis, Chi-square were used for data analysis. Results: The three groups do not have statistically significant different regarding demographic and other intervening variables. Comparing the mean of REEDA in five days after delivery showed statistically significant difference between control and experimental groups.Conclusion: According to the results, using Aloe vera and Calendula ointment considerably increases the speed of episiotomy wound healing so it can be used for quickening the episiotomy healing.

  17. Impact of data from recent clinical trials on strategies for treating patients with type 2 diabetes mellitus

    Directory of Open Access Journals (Sweden)

    Pasquale J Palumbo

    2010-01-01

    Full Text Available Pasquale J Palumbo1, Jonathan M Wert21Department of Endocrinology, Mayo Clinic College of Medicine, Scottsdale, AZ, USA; 2BlueSpark Healthcare Communications, Basking Ridge, NJ, USAAbstract: Type 2 diabetes is associated with increased risk for the development of cardiovascular disease (CVD secondary to hyperglycemia’s toxicity to blood vessels. The escalating incidence of CVD among patients with type 2 diabetes has prompted research into how lowering glycated hemoglobin (HbA1c may improve CVD-related morbidity and mortality. Data from recent studies have shown that some patients with type 2 diabetes actually have increased mortality after achieving the lowest possible HbA1c using intensive antidiabetes treatment. Multiple factors, such as baseline HbA1c, duration of diabetes, pancreatic β-cell decline, presence of overweight/obesity, and the pharmacologic durability of antidiabetes medications influence diabetes treatment plans and therapeutic results. Hypertension and dyslipidemia are common comorbidities in patients with type 2 diabetes, which impact the risk of CVD independently of glycemic control. Consideration of all of these risk factors provides the best option for reducing morbidity and mortality in patients with type 2 diabetes. Based on the results of recent trials, the appropriate use of current antidiabetes therapies can optimize glycemic control, but use of intensive glucoselowering therapy will need to be tailored to individual patient needs and risks.Keywords: type 2 diabetes, diabetes treatment, incretin-based therapies, glucose control, HbA1c, cardiovascular disease

  18. The impact of schoolwide positive behavioral interventions and supports on bullying and peer rejection: a randomized controlled effectiveness trial.

    Science.gov (United States)

    Waasdorp, Tracy E; Bradshaw, Catherine P; Leaf, Philip J

    2012-02-01

    To build on prior research documenting the impact of School-wide Positive Behavioral Interventions and Supports (SWPBIS) on school climate and discipline problems to examine the extent to which it affects bullying and peer rejection during the transition into early adolescence. Three-level models were fit using hierarchical linear modeling to determine the effect of SWPBIS on children's involvement in bullying. Thirty-seven Maryland public elementary schools. Data involved 12 344 children (52.9% male, 45.1% African American, 46.1% white) followed up longitudinally across 4 school years. A randomized controlled effectiveness trial of SWPBIS. Reports from teachers on bully-related behaviors were assessed through the Teacher Observation of Classroom Adaptation-Checklist. Analyses indicated that children in schools that implemented SWPBIS displayed lower rates of teacher-reported bullying and peer rejection than those in schools without SWPBIS. A significant interaction also emerged between grade level of first exposure to SWPBIS and intervention status, suggesting that the effects of SWPBIS on rejection were strongest among children who were first exposed to SWPBIS at a younger age. The results indicated that SWPBIS has a significant effect on teachers' reports of children's involvement in bullying as victims and perpetrators. The findings were considered in light of other outcomes for students, staff, and the school environment, and they suggest that SWPBIS may help address the increasing national concerns related to school bullying by improving school climate.

  19. Impact of clinical decision support on radiography for acute ankle injuries: a randomized trial

    Directory of Open Access Journals (Sweden)

    Shahein Tajmir

    2017-04-01

    Full Text Available Introduction: While only 15-20% of patients with foot and ankle injuries presenting to urgent care centers have clinically significant fractures, most undergo radiography. We examined the impact of electronic point-of-care clinical decision support (CDS on adherence to the Ottawa Ankle Rules (OAR, as well as use and yield of foot and ankle radiographs in patients with acute ankle injury. Methods: We obtained institutional review board approval for this randomized controlled study performed April 18, 2012—December 15, 2013. All ordering providers credentialed at an urgent care affiliated with a quaternary care academic hospital were randomized to either receive or not receive CDS, based on the OAR and integrated into the physician order-entry system, with feedback at the time of imaging order. If the patient met OAR low-risk criteria, providers were advised against imaging and could either cancel the order or ignore the alert. We identified patients with foot and ankle complaints via ICD-9 billing codes and electronic health records and radiology reports reviewed for those who were eligible. Chi-square was used to compare adherence to the OAR (primary outcome, radiography utilization rate and radiography yield of foot and ankle imaging (secondary outcomes between the intervention and control groups. Results: Of 14,642 patients seen at urgent care during the study period, 613 (4.2%, representing 632 visits presented with acute ankle injury and were eligible for application of the OAR; 374 (59.2% of these were seen by control-group providers. In the intervention group, CDS adherence was higher for both ankle (239/258=92.6% vs. 231/374=61.8%, p=0.02 and foot radiography (209/258=81.0% vs. 238/374=63.6%; p<0.01. However, ankle radiography use was higher in the intervention group (166/258=64.3% vs. 183/374=48.9%; p<0.01, while foot radiography use (141/258=54.6% vs. 202/374=54.0%; p=0.95 was not. Radiography yield was also higher in the intervention

  20. Call for Papers: Special Issue

    African Journals Online (AJOL)

    Inevitably, learning and teaching facilities are under the impact of such changes. As indicated by O'Reilly (2005), web ... Inquiry into the education implications of technological developments promises interesting knowledge contributions for a range ... English Language Teaching, 6:19-25. Completed manuscripts should be ...

  1. The experience of work in a call centre environment

    Directory of Open Access Journals (Sweden)

    Sanet Hauptfleisch

    2006-02-01

    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.

  2. 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

    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......-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...

  3. A review and additional post-hoc analyses of the incidence and impact of constipation observed in darifenacin clinical trials

    Directory of Open Access Journals (Sweden)

    Tack J

    2012-09-01

    Full Text Available Jan Tack,1 Jean-Jacques Wyndaele,2 Greg Ligozio,3 Mathias Egermark41University of Leuven, Gastroenterology Section, Leuven, 2University of Antwerp, Department of Urology, Antwerp, Belgium; 3Novartis Pharmaceuticals Corporation, NJ, USA; 4Roche Diagnostics Scandinavia AB, Bromma, Sweden and formerly of Novartis Pharma AG, Basel, SwitzerlandBackground: Constipation is a common side effect of antimuscarinic treatment for overactive bladder (OAB. This review evaluates the incidence and impact of constipation on the lives of patients with OAB being treated with darifenacin.Methods: Constipation data from published Phase III and Phase IIIb/IV darifenacin studies were reviewed and analyzed. Over 4000 patients with OAB (aged 18–89 years; ≥80% female enrolled in nine studies (three Phase III [data from these fixed-dose studies were pooled and provide the primary focus for this review], three Phase IIIb, and three Phase IV. The impact of constipation was assessed by discontinuations, use of concomitant laxatives, patient-reported perception of treatment, and a bowel habit questionnaire.Results: In the pooled Phase III trials, 14.8% (50/337 of patients on darifenacin 7.5 mg/day and 21.3% (71/334 on 15 mg/day experienced constipation compared with 12.6% (28/223 and 6.2% (24/388 with tolterodine and placebo, respectively. In addition, a few patients discontinued treatment due to constipation (0.6% [2/337], 1.2% [4/334], 1.8% [4/223], and 0.3% [1/388] in the darifenacin 7.5 mg/day or 15 mg/day, tolterodine, and placebo groups, respectively, or required concomitant laxatives (3.3% [11/337], 6.6% [22/334], 7.2% [16/223], and 1.5% [6/388] in the darifenacin 7.5 mg/day or 15 mg/day, tolterodine, and placebo groups, respectively. Patient-reported perception of treatment quality was observed to be similar between patients who experienced constipation and those who did not. During the long-term extension study, a bowel habit questionnaire showed only small

  4. HPTN 071 (PopART): Rationale and design of a cluster-randomised trial of the population impact of an HIV combination prevention intervention including universal testing and treatment – a study protocol for a cluster randomised trial

    Science.gov (United States)

    2014-01-01

    Background Effective interventions to reduce HIV incidence in sub-Saharan Africa are urgently needed. Mathematical modelling and the HIV Prevention Trials Network (HPTN) 052 trial results suggest that universal HIV testing combined with immediate antiretroviral treatment (ART) should substantially reduce incidence and may eliminate HIV as a public health problem. We describe the rationale and design of a trial to evaluate this hypothesis. Methods/Design A rigorously-designed trial of universal testing and treatment (UTT) interventions is needed because: i) it is unknown whether these interventions can be delivered to scale with adequate uptake; ii) there are many uncertainties in the models such that the population-level impact of these interventions is unknown; and ii) there are potential adverse effects including sexual risk disinhibition, HIV-related stigma, over-burdening of health systems, poor adherence, toxicity, and drug resistance. In the HPTN 071 (PopART) trial, 21 communities in Zambia and South Africa (total population 1.2 m) will be randomly allocated to three arms. Arm A will receive the full PopART combination HIV prevention package including annual home-based HIV testing, promotion of medical male circumcision for HIV-negative men, and offer of immediate ART for those testing HIV-positive; Arm B will receive the full package except that ART initiation will follow current national guidelines; Arm C will receive standard of care. A Population Cohort of 2,500 adults will be randomly selected in each community and followed for 3 years to measure the primary outcome of HIV incidence. Based on model projections, the trial will be well-powered to detect predicted effects on HIV incidence and secondary outcomes. Discussion Trial results, combined with modelling and cost data, will provide short-term and long-term estimates of cost-effectiveness of UTT interventions. Importantly, the three-arm design will enable assessment of how much could be achieved by

  5. Step-wedge cluster-randomised community-based trials: An application to the study of the impact of community health insurance

    Directory of Open Access Journals (Sweden)

    Kynast-Wolf Gisela

    2008-10-01

    Full Text Available Abstract Background We describe a step-wedge cluster-randomised community-based trial which has been conducted since 2003 to accompany the implementation of a community health insurance (CHI scheme in West Africa. The trial aims at overcoming the paucity of evidence-based information on the impact of CHI. Impact is defined in terms of changes in health service utilisation and household protection against the cost of illness. Our exclusive focus on the description and discussion of the methods is justified by the fact that the study relies on a methodology previously applied in the field of disease control, but never in the field of health financing. Methods First, we clarify how clusters were defined both in respect of statistical considerations and of local geographical and socio-cultural concerns. Second, we illustrate how households within clusters were sampled. Third, we expound the data collection process and the survey instruments. Finally, we outline the statistical tools to be applied to estimate the impact of CHI. Conclusion We discuss all design choices both in relation to methodological considerations and to specific ethical and organisational concerns faced in the field. On the basis of the appraisal of our experience, we postulate that conducting relatively sophisticated trials (such as our step-wedge cluster-randomised community-based trial aimed at generating sound public health evidence, is both feasible and valuable also in low income settings. Our work shows that if accurately designed in conjunction with local health authorities, such trials have the potential to generate sound scientific evidence and do not hinder, but at times even facilitate, the implementation of complex health interventions such as CHI.

  6. Learner Attitudes towards CALL Applications at YADIM

    Directory of Open Access Journals (Sweden)

    Zuhal OKAN & Pınar TORUN

    2014-01-01

    Full Text Available The use of educational technology to assist learners in their language studies has become agreat concern for scholars over the past decade. YADIM (School for Foreign Languages at ÇukurovaUniversity in Turkey has invested substantially to introduce students to computer-based languagelearning materials and to integrate technology into existing curriculum. This paper reports on attitudesof YADİM students towards the use of computer-assisted language learning (CALL and theirperceptions on CALL’s relevancy to their regular classroom work. Surveys and follow-up interviewsexplored how learners see the role of the instructor and the accessibility of the labs. The paper alsolooks at how students assess the impact of technology on their language learning process.

  7. 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

    2016-02-19

    To investigate whether intergroup contact in addition to education is more effective than education alone in reducing stigma of mental illness in adolescents. 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. Secondary schools in Birmingham, UK. The parents and guardians of all students in year 8 (age 12-13 years) were approached to take part. 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. 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. 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. 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 reducing stigma, promoting mental health knowledge, and increasing mental health literacy, as

  8. Comparison of the impact of SFAs from cheese and butter on cardiometabolic risk factors: a randomized controlled trial.

    Science.gov (United States)

    Brassard, Didier; Tessier-Grenier, Maude; Allaire, Janie; Rajendiran, Ethendhar; She, Yongbo; Ramprasath, Vanu; Gigleux, Iris; Talbot, Denis; Levy, Emile; Tremblay, Angelo; Jones, Peter Jh; Couture, Patrick; Lamarche, Benoît

    2017-04-01

    Background: Controversies persist concerning the association between intake of dietary saturated fatty acids (SFAs) and cardiovascular disease risk. Objective: We compared the impact of consuming equal amounts of SFAs from cheese and butter on cardiometabolic risk factors. Design: In a multicenter, crossover, randomized controlled trial, 92 men and women with abdominal obesity and relatively low HDL-cholesterol concentrations were assigned to sequences of 5 predetermined isoenergetic diets of 4 wk each separated by 4-wk washouts: 2 diets rich in SFAs (12.4-12.6% of calories) from either cheese or butter; a monounsaturated fatty acid (MUFA)-rich diet (SFAs: 5.8%, MUFAs: 19.6%); a polyunsaturated fatty acid (PUFA)-rich diet (SFAs: 5.8%, PUFAs: 11.5%); and a low-fat, high-carbohydrate diet (fat: 25%, SFAs: 5.8%). Results: Serum HDL-cholesterol concentrations were similar after the cheese and butter diets but were significantly higher than after the carbohydrate diet (+3.8% and +4.7%, respectively; P cholesterol concentrations after the cheese diet were lower than after the butter diet (-3.3%, P cholesterol concentrations after the butter diet also increased significantly (from +6.1% to +16.2%, P cholesterol response to treatment was significantly modified by baseline values ( P -interaction = 0.02), with the increase in LDL cholesterol being significantly greater with butter than with cheese only among individuals with high baseline LDL-cholesterol concentrations. There was no significant difference between all diets on inflammation markers, blood pressure, and insulin-glucose homeostasis. Conclusions: The results of our study suggest that the consumption of SFAs from cheese and butter has similar effects on HDL cholesterol but differentially modifies LDL-cholesterol concentrations compared with the effects of carbohydrates, MUFAs, and PUFAs, particularly in individuals with high LDL cholesterol. In contrast, SFAs from either cheese or butter have no significant

  9. Impact of proton pump inhibitor therapy on the efficacy of clopidogrel in the CAPRIE and CREDO trials.

    Science.gov (United States)

    Dunn, Steven P; Steinhubl, Steven R; Bauer, Deborah; Charnigo, Richard J; Berger, Peter B; Topol, Eric J

    2013-01-15

    Proton pump inhibitors (PPIs) may interfere with the metabolic activation of clopidogrel via inhibition of cytochrome P450 2C19, but the clinical implications remain unclear. The impact of PPI use on the 1-year primary end point (ischemic stroke, myocardial infarction [MI], or vascular death) in the Clopidogrel versus Aspirin in Patients at Risk of Ischemic Events (CAPRIE) trial and the 28-day (all-cause death, MI, or urgent target vessel revascularization) and 1-year (all-cause death, MI, or stroke) primary end points in the Clopidogrel for Reduction of Events During Observation (CREDO) trial were examined. Clopidogrel appeared to elevate risk for the primary end point in CAPRIE among PPI users (estimated hazard ratio [EHR] 2.66, 95% CI 0.94 to 7.50) while lowering it for non-PPI users (EHR 0.90, 95% CI 0.83 to 0.99, interaction P=0.047). Moreover, PPI use was associated with worse outcomes in patients receiving clopidogrel (EHR 2.39, 95% CI 1.74 to 3.28) but not aspirin (EHR 1.04, 95% CI 0.70 to 1.57, interaction P=0.001). Clopidogrel did not significantly alter risk for the 1-year primary end point in CREDO among PPI users (EHR 0.82, 95% CI 0.48 to 1.40) while lowering it for non-PPI users (EHR 0.71, 95% CI 0.52 to 0.98, interaction P=0.682). Also, PPI use was associated with worse outcomes in both patients receiving clopidogrel (EHR 1.67, 95% CI 1.06 to 2.64) and those receiving placebo (EHR 1.56, 95% CI 1.06 to 2.30, interaction P=0.811). In CREDO, the efficacy of clopidogrel was not significantly affected by PPI use. However, in CAPRIE, clopidogrel was beneficial to non-PPI users while apparently harmful to PPI users. Whether this negative interaction is clinically important for patients receiving clopidogrel without aspirin needs further study.

  10. Impact of Proton Pump Inhibitor Therapy on the Efficacy of Clopidogrel in the CAPRIE and CREDO Trials

    Science.gov (United States)

    Dunn, Steven P.; Steinhubl, Steven R.; Bauer, Deborah; Charnigo, Richard J.; Berger, Peter B.; Topol, Eric J.

    2013-01-01

    Background Proton pump inhibitors (PPIs) may interfere with the metabolic activation of clopidogrel via inhibition of cytochrome P450 2C19, but the clinical implications remain unclear. Methods and Results The impact of PPI use on the 1‐year primary end point (ischemic stroke, myocardial infarction [MI], or vascular death) in the Clopidogrel versus Aspirin in Patients at Risk of Ischemic Events (CAPRIE) trial and the 28‐day (all‐cause death, MI, or urgent target vessel revascularization) and 1‐year (all‐cause death, MI, or stroke) primary end points in the Clopidogrel for Reduction of Events During Observation (CREDO) trial were examined. Clopidogrel appeared to elevate risk for the primary end point in CAPRIE among PPI users (estimated hazard ratio [EHR] 2.66, 95% CI 0.94 to 7.50) while lowering it for non‐PPI users (EHR 0.90, 95% CI 0.83 to 0.99, interaction P=0.047). Moreover, PPI use was associated with worse outcomes in patients receiving clopidogrel (EHR 2.39, 95% CI 1.74 to 3.28) but not aspirin (EHR 1.04, 95% CI 0.70 to 1.57, interaction P=0.001). Clopidogrel did not significantly alter risk for the 1‐year primary end point in CREDO among PPI users (EHR 0.82, 95% CI 0.48 to 1.40) while lowering it for non‐PPI users (EHR 0.71, 95% CI 0.52 to 0.98, interaction P=0.682). Also, PPI use was associated with worse outcomes in both patients receiving clopidogrel (EHR 1.67, 95% CI 1.06 to 2.64) and those receiving placebo (EHR 1.56, 95% CI 1.06 to 2.30, interaction P=0.811). Conclusions In CREDO, the efficacy of clopidogrel was not significantly affected by PPI use. However, in CAPRIE, clopidogrel was beneficial to non‐PPI users while apparently harmful to PPI users. Whether this negative interaction is clinically important for patients receiving clopidogrel without aspirin needs further study. PMID:23525436

  11. 78 FR 76218 - Rural Call Completion

    Science.gov (United States)

    2013-12-17

    ..., to the extent such service offers the capability to place calls to or receive calls from the PSTN. 6... restricting telephone traffic in response to continued complaints about rural call completion issues from.... In August 2013, ATIS and NECA announced a voluntary Joint National Call Testing Project offering...

  12. 47 CFR 2.302 - Call signs.

    Science.gov (United States)

    2010-10-01

    ... 47 Telecommunication 1 2010-10-01 2010-10-01 false Call signs. 2.302 Section 2.302... RULES AND REGULATIONS Call Signs and Other Forms of Identifying Radio Transmissions § 2.302 Call signs. The table which follows indicates the composition and blocks of international call signs available for...

  13. Assessing the Health Impact of Trade: A Call for an Expanded Research Agenda; Comment on “The Trans-Pacific Partnership: Is It Everything We Feared for Health?”

    Directory of Open Access Journals (Sweden)

    Courtney McNamara

    2017-05-01

    Full Text Available Labonté et al provide an insightful analysis of the Trans-Pacific Partnership (TPP and its impact on a selection of important health determinants. Their work confirms concerns raised by previous analyses of leaked drafts and offers governments serious and timely reasons to carefully consider provisions of the agreement prior to moving forward with ratification. It also contributes more generally to a growing literature focused on identifying the health impacts of trade. This commentary uses the authors’ analysis as a starting point to reflect on two interrelated issues relevant both for taking seriously one of the article’s main recommendations and future work in the area of trade and health.

  14. 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.

  15. A hierarchy of patient-reported outcomes for meta-analysis of knee osteoarthritis trials: empirical evidence from a survey of high impact journals.

    Science.gov (United States)

    Juhl, Carsten; Lund, Hans; Roos, Ewa M; Zhang, Weiya; Christensen, Robin

    2012-01-01

    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.

  16. Impact of a School-Based Hygiene Promotion and Sanitation Intervention on Pupil Hand Contamination in Western Kenya: A Cluster Randomized Trial

    OpenAIRE

    Greene, Leslie E.; Freeman, Matthew C.; Akoko, Daniel; Saboori, Shadi; Moe, Christine; Rheingans, Richard

    2012-01-01

    Handwashing with soap effectively reduces exposure to diarrhea-causing pathogens. Interventions to improve hygiene and sanitation conditions in schools within low-income countries have gained increased attention; however, their impact on schoolchildren's exposure to fecal pathogens has not been established. Our trial examined whether a school-based water, sanitation, and hygiene intervention reduced Escherichia coli contamination on pupils' hands in western Kenya. A hygiene promotion and wate...

  17. 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.

  18. Rare disease registries: a call to action.

    Science.gov (United States)

    Lacaze, Paul; Millis, Nicole; Fookes, Megan; Zurynski, Yvonne; Jaffe, Adam; Bellgard, Matthew; Winship, Ingrid; McNeil, John; Bittles, Alan H

    2017-09-01

    When registries collect accurate clinical data over time, they can act as fundamental support structures for patients and their families and powerful cost-effective instruments to support clinical trials and translational research to improve quality of care, quality of life and survival. Registries are critical for rare diseases (RD) with low prevalence and propensity for variation in treatment and outcomes. Rare Voices Australia is leading a call for action to the research and clinical community to prioritise RD data collection and develop an integrated RD Registry strategy for Australia. Financial, operational and governance challenges exist for establishing and maintaining RD registries. As a multidisciplinary team whose interests converge on RD, we highlight the need for the establishment of an Australian RD Registry Alliance. This 'umbrella' organisation will: (i) bring together existing RD registries across Australia; (ii) establish National RD Registry Standards to support interoperability and cohesion across registries; (iii) develop strategies to attract sustainable funding from government and other sources to maximise the utility of existing RD registries and support the development of new RD registries. The most important role for the Alliance would be to use the RD registries for translational research to address current knowledge gaps about RD and to improve the care for the over 1.4 million Australians estimated to live with RD. © 2017 Royal Australasian College of Physicians.

  19. 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.

    Science.gov (United States)

    de Boer, Stephanie M; Nout, Remi A; Jürgenliemk-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

    2015-11-15

    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. 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 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. 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. Copyright © 2015 Elsevier Inc. All rights reserved.

  20. Impact of Selection Bias on Treatment Effect Size Estimates in Randomized Trials of Oral Health Interventions: A Meta-epidemiological Study.

    Science.gov (United States)

    Saltaji, H; Armijo-Olivo, S; Cummings, G G; Amin, M; da Costa, B R; Flores-Mir, C

    2018-01-01

    Emerging evidence suggests that design flaws of randomized controlled trials can result in over- or underestimation of the treatment effect size (ES). The objective of this study was to examine associations between treatment ES estimates and adequacy of sequence generation, allocation concealment, and baseline comparability among a sample of oral health randomized controlled trials. For our analysis, we selected all meta-analyses that included a minimum of 5 oral health randomized controlled trials and used continuous outcomes. We extracted data, in duplicate, related to items of selection bias (sequence generation, allocation concealment, and baseline comparability) in the Cochrane Risk of Bias tool. Using a 2-level meta-meta-analytic approach with a random effects model to allow for intra- and inter-meta-analysis heterogeneity, we quantified the impact of selection bias on the magnitude of ES estimates. We identified 64 meta-analyses, including 540 randomized controlled trials analyzing 137,957 patients. Sequence generation was judged to be adequate (at low risk of bias) in 32% ( n = 173) of trials, and baseline comparability was judged to be adequate in 77.8% of trials. Allocation concealment was unclear in the majority of trials ( n = 458, 84.8%). We identified significantly larger treatment ES estimates in trials that had inadequate/unknown sequence generation (difference in ES = 0.13; 95% CI: 0.01 to 0.25) and inadequate/unknown allocation concealment (difference in ES = 0.15; 95% CI: 0.02 to 0.27). In contrast, baseline imbalance (difference in ES = 0.01, 95% CI: -0.09 to 0.12) was not associated with inflated or underestimated ES. In conclusion, treatment ES estimates were 0.13 and 0.15 larger in trials with inadequate/unknown sequence generation and inadequate/unknown allocation concealment, respectively. Therefore, authors of systematic reviews using oral health randomized controlled trials should perform sensitivity analyses based on the adequacy of

  1. HPTN 071 (PopART): rationale and design of a cluster-randomised trial of the population impact of an HIV combination prevention intervention including universal testing and treatment - a study protocol for a cluster randomised trial.

    Science.gov (United States)

    Hayes, Richard; Ayles, Helen; Beyers, Nulda; Sabapathy, Kalpana; Floyd, Sian; Shanaube, Kwame; Bock, Peter; Griffith, Sam; Moore, Ayana; Watson-Jones, Deborah; Fraser, Christophe; Vermund, Sten H; Fidler, Sarah

    2014-02-13

    Effective interventions to reduce HIV incidence in sub-Saharan Africa are urgently needed. Mathematical modelling and the HIV Prevention Trials Network (HPTN) 052 trial results suggest that universal HIV testing combined with immediate antiretroviral treatment (ART) should substantially reduce incidence and may eliminate HIV as a public health problem. We describe the rationale and design of a trial to evaluate this hypothesis. A rigorously-designed trial of universal testing and treatment (UTT) interventions is needed because: i) it is unknown whether these interventions can be delivered to scale with adequate uptake; ii) there are many uncertainties in the models such that the population-level impact of these interventions is unknown; and ii) there are potential adverse effects including sexual risk disinhibition, HIV-related stigma, over-burdening of health systems, poor adherence, toxicity, and drug resistance.In the HPTN 071 (PopART) trial, 21 communities in Zambia and South Africa (total population 1.2 m) will be randomly allocated to three arms. Arm A will receive the full PopART combination HIV prevention package including annual home-based HIV testing, promotion of medical male circumcision for HIV-negative men, and offer of immediate ART for those testing HIV-positive; Arm B will receive the full package except that ART initiation will follow current national guidelines; Arm C will receive standard of care. A Population Cohort of 2,500 adults will be randomly selected in each community and followed for 3 years to measure the primary outcome of HIV incidence. Based on model projections, the trial will be well-powered to detect predicted effects on HIV incidence and secondary outcomes. Trial results, combined with modelling and cost data, will provide short-term and long-term estimates of cost-effectiveness of UTT interventions. Importantly, the three-arm design will enable assessment of how much could be achieved by optimal delivery of current policies and

  2. Contraception use and impact on pregnancy prevention in women participating in an HIV prevention trial in South Africa.

    Science.gov (United States)

    Moodley, Jayajothi; Naidoo, Sarita; Wand, Handan; Ramjee, Gita

    2016-01-01

    Unplanned pregnancy rates in South Africa are high. Effective use of contraception is therefore an essential public health intervention to prevent unplanned pregnancies. This study describes contraception use and its impact on pregnancy in women participating in HIV prevention research and its implications for public health practice. A secondary analysis of sociodemographic, behavioural, contraception use, and pregnancy incidence data was conducted amongst women participating in the Microbicides Development Programme (MDP) 301 trial conducted in Durban, South Africa. Log-rank tests were carried out to compare the pregnancy incidence between women who reported use of injectable contraceptive methods compared to women using oral contraceptive pills, using condoms and other methods (intrauterine device, traditional methods and natural methods). The effect of types of contraceptives on pregnancy incidence was assessed using Cox proportional hazards regression models. Of the 2018 women enrolled, injectable contraception was the most commonly used method (52%) compared to pills, condoms for pregnancy prevention and other methods. Injectable contraception use was associated with lower crude pregnancy incidence of 4.4 per 100 woman-years [95% confidence interval (95% CI 3.3-5.9)] compared to women using pills [19.3 per 100 woman-years (95% CI 13.3-28.0)], condoms [19.7 per 100 woman-years (95% CI 16.3-23.6)] and other methods [11.5 per 100 woman-years (95% CI 7.5-17.6)]. This effect remained significant when adjusted for age, level of education, condom use at last sex act [hazard ratio 0.27, (95% CI 0.16-0.47, pcontraception offered a high level of protection against pregnancies among women in Durban. ISRCTN64716212. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  3. Impact of Compliance on Dysphagia Rehabilitation in Head and Neck Cancer Patients: Results from a Multi-center Clinical Trial.

    Science.gov (United States)

    Krisciunas, Gintas P; Castellano, Kerlly; McCulloch, Timothy M; Lazarus, Cathy L; Pauloski, Barbara R; Meyer, Tanya K; Graner, Darlene; Van Daele, Douglas J; Silbergleit, Alice K; Crujido, Lisa R; Rybin, Denis; Doros, Gheorghe; Kotz, Tamar; Langmore, Susan E

    2017-04-01

    A 5-year, 16-site, randomized controlled trial enrolled 170 HNC survivors into active (estim + swallow exercise) or control (sham estim + swallowing exercise) arms. Primary analyses showed that estim did not enhance swallowing exercises. This secondary analysis determined if/how patient compliance impacted outcomes. A home program, performed 2 times/day, 6 days/week, for 12 weeks included stretches and 60 swallows paired with real or sham estim. Regular clinic visits ensured proper exercise execution, and detailed therapy checklists tracked patient compliance which was defined by mean number of sessions performed per week (0-12 times) over the 12-week intervention period. "Compliant" was defined as performing 10-12 sessions/week. Outcomes were changes in PAS, HNCI, PSS, OPSE, and hyoid excursion. ANCOVA analyses determined if outcomes differed between real/sham and compliant/noncompliant groups after 12 weeks of therapy. Of the 170 patients enrolled, 153 patients had compliance data. The mean number of sessions performed was 8.57/week (median = 10.25). Fifty-four percent of patients (n = 83) were considered "compliant." After 12 weeks of therapy, compliant patients in the sham estim group realized significantly better PAS scores than compliant patients in the active estim group (p = 0.0074). When pooling all patients together, there were no significant differences in outcomes between compliant and non-compliant patients. The addition of estim to swallowing exercises resulted in worse swallowing outcomes than exercises alone, which was more pronounced in compliant patients. Since neither compliant nor non-compliant patients benefitted from swallowing exercises, the proper dose and/or efficacy of swallowing exercises must also be questioned in this patient population.

  4. Impact of the Bienestar school-based diabetes mellitus prevention program on fasting capillary glucose levels: a randomized controlled trial.

    Science.gov (United States)

    Treviño, Roberto P; Yin, Zenong; Hernandez, Arthur; Hale, Daniel E; Garcia, Oralia A; Mobley, Connie

    2004-09-01

    To evaluate the impact of a school-based diabetes mellitus prevention program on low-income fourth-grade Mexican American children. A randomized controlled trial with 13 intervention and 14 control schools. Elementary schools in inner-city neighborhoods in San Antonio, Tex. Eighty percent of participants were Mexican American and 94% were from economically disadvantaged households. Baseline and follow-up measures were collected from 1419 (713 intervention and 706 control) and 1221 (619 intervention and 602 control) fourth-grade children, respectively. The Bienestar Health Program consists of a health class and physical education curriculum, a family program, a school cafeteria program, and an after-school health club. The objectives are to decrease dietary saturated fat intake, increase dietary fiber intake, and increase physical activity. The primary end point was fasting capillary glucose level, and the secondary end points were percentage of body fat, physical fitness level, dietary fiber intake, and dietary saturated fat intake. Fasting capillary glucose level, bioelectric impedance, modified Harvard step test, three 24-hour dietary recalls, weight, and height were collected at baseline and 8 months later. Children in the intervention arm attended an average of 32 Bienestar sessions. Mean fasting capillary glucose levels decreased in intervention schools and increased in control schools after adjusting for covariates (-2.24 mg/dL [0.12 mmol/L]; 95% confidence interval, -6.53 to 2.05 [-0.36 to 0.11 mmol/L]; P =.03). Fitness scores (P =.04) and dietary fiber intake (P =.009) significantly increased in intervention children and decreased in control children. Percentage of body fat (P =.56) and dietary saturated fat intake (P =.52) did not differ significantly between intervention and control children. This intervention showed some positive results, but additional research is needed to examine long-term benefits, translation, and cost-effectiveness.

  5. Impact of counselling on exclusive breast-feeding practices in a poor urban setting in Kenya: a randomized controlled trial.

    Science.gov (United States)

    Ochola, Sophie A; Labadarios, Demetre; Nduati, Ruth W

    2013-10-01

    To determine the impact of facility-based semi-intensive and home-based intensive counselling in improving exclusive breast-feeding (EBF) in a low-resource urban setting in Kenya. A cluster randomized controlled trial in which nine villages were assigned on a 1:1:1 ratio, by computer, to two intervention groups and a control group. The home-based intensive counselling group (HBICG) received seven counselling sessions at home by trained peers, one prenatally and six postnatally. The facility-based semi-intensive counselling group (FBSICG) received only one counselling session prenatally. The control group (CG) received no counselling from the research team. Information on infant feeding practices was collected monthly for 6 months after delivery. The data-gathering team was blinded to the intervention allocation. The outcome was EBF prevalence at 6 months. Kibera slum, Nairobi. A total of 360 HIV-negative women, 34-36 weeks pregnant, were selected from an antenatal clinic in Kibera; 120 per study group. Of the 360 women enrolled, 265 completed the study and were included in the analysis (CG n 89; FBSICG n 87; HBICG n 89). Analysis was by intention to treat. The prevalence of EBF at 6 months was 23.6% in HBICG, 9.2% in FBSICG and 5.6% in CG. HBICG mothers had four times increased likelihood to practise EBF compared with those in the CG (adjusted relative risk = 4.01; 95% CI 2.30, 7.01; P=0.001). There was no significant difference between EBF rates in FBSICG and CG. EBF can be promoted in low socio-economic conditions using home-based intensive counselling. One session of facility-based counselling is not sufficient to sustain EBF.

  6. Demographic characteristics of systematic reviews, meta-analyses, and randomized controlled trials in orthodontic journals with impact factor.

    Science.gov (United States)

    Kanavakis, Georgios; Dombroski, Meghann M; Malouf, David P; Athanasiou, Athanasios E

    2016-02-01

    The aim of this study was to explore demographic characteristics of systematic reviews (SRs), meta-analyses (MAs), and randomized controlled trials (RCTs) published in orthodontic journals with an impact factor (IF). An electronic search was developed and implemented to identify all the SRs, MAs, and RCTs published in the seven orthodontic journals with an IF. No restrictions were applied regarding language, publication date, or publication status. The initial search generated 1147 articles, which were reviewed by three authors in order to determine if they met the inclusion criteria. Five hundred and fifty-seven articles were included in the final analysis. Type of article, name of journal, year of publication, number of authors, country of origin, and primary affiliation were recorded. Associations between those parameters were tested with the Pearson chi-square test for independence at the 0.05 level of significance. The majority (72%) of this kind of articles published in the orthodontic literature were RCTs, followed by SRs (20.1%) and MAs (7.9%). Approximately 77.2% of all RCTs, SRs, and MAs were published between 2004 and 2013, and 72.9% came from orthodontic departments. More than 80% of all articles were collaborative efforts between three or more authors. Contributions from Asia, South and Central America significantly increased during last decade, while contributions from North America decreased by almost 30%. Most RCTs, MAs, and SRs have been published between 2004 and 2013, indicating a significant improvement of the orthodontic literature during the last decade. Asia, South and Central America have significantly increased their contributions to the high evidence orthodontic literature since 2004. © The Author 2015. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  7. Impact of a parent-child sexual communication campaign: results from a controlled efficacy trial of parents

    Directory of Open Access Journals (Sweden)

    Evans W Douglas

    2010-07-01

    Full Text Available Abstract Background Prior research supports the notion that parents have the ability to influence their children's decisions regarding sexual behavior. Yet parent-based approaches to curbing teen pregnancy and STDs have been relatively unexplored. The Parents Speak Up National Campaign (PSUNC is a multimedia campaign that attempts to fill this void by targeting parents of teens to encourage parent-child communication about waiting to have sex. The campaign follows a theoretical framework that identifies cognitions that are targeted in campaign messages and theorized to influence parent-child communication. While a previous experimental study showed PSUNC messages to be effective in increasing parent-child communication, it did not address how these effects manifest through the PSUNC theoretical framework. The current study examines the PSUNC theoretical framework by 1 estimating the impact of PSUNC on specific cognitions identified in the theoretical framework and 2 examining whether those cognitions are indeed associated with parent-child communication Methods Our study consists of a randomized efficacy trial of PSUNC messages under controlled conditions. A sample of 1,969 parents was randomly assigned to treatment (PSUNC exposure and control (no exposure conditions. Parents were surveyed at baseline, 4 weeks, 6 months, 12 months, and 18 months post-baseline. Linear regression procedures were used in our analyses. Outcome variables included self-efficacy to communicate with child, long-term outcome expectations that communication would be successful, and norms on appropriate age for sexual initiation. We first estimated multivariable models to test whether these cognitive variables predict parent-child communication longitudinally. Longitudinal change in each cognitive variable was then estimated as a function of treatment condition, controlling for baseline individual characteristics. Results Norms related to appropriate age for sexual

  8. Positive impact of child feeding training program for primary care health professionals: a cluster randomized field trial

    Directory of Open Access Journals (Sweden)

    Márcia Regina Vitolo

    2014-12-01

    Full Text Available OBJECTIVE: To assess the impact of a child feeding training program for primary care health professionals about breastfeeding and complementary feeding practices. METHODS: Cluster-randomized field trial conducted in the city of Porto Alegre, (RS, Brazil. Twenty primary health care centers (HCC were randomized into intervention (n = 9 and control (n = 11 groups. The health professionals (n = 200 at the intervention group centers received training about healthy feeding practices. Pregnant women were enrolled at the study. Up to six months of child's age, home visits were made to obtain variables related to breastfeeding and introduction of foods. RESULTS: 619 children were evaluated: 318 from the intervention group and 301 from the control group. Exclusive breastfeeding prevalence in the first (72.3 versus 59.4%; RR = 1.21; 95%CI 1.08 - 1.38, second (62.6 versus 48.2%; RR = 1.29; 95%CI 1.10 - 1.53, and third months of life (44.0% versus 34.6%; RR = 1.27; 95%CI 1.04 - 1.56 was higher in the intervention group compared to the control group. The prevalence of children who consumed meat four or five times per week was higher in the intervention group than in the control group (36.8 versus 22.6%; RR = 1.62; 95%CI 1.32 - 2.03. The prevalence of children who had consumed soft drinks (34.9 versus 52.5%; RR = 0.66; 95%CI 0.54 - 0.80, chocolate (24.5 versus 36.7% RR = 0.66 95%CI 0.53 - 0.83, petit suisse (68.9 versus 79.7; 95%CI 0.75 - 0.98 and coffee (10.4 versus 20.1%; RR = 0.51; 95%CI 0.31 - 0.85 in their six first months of life was lower in the intervention group. CONCLUSION: The training of health professionals had a positive impact on infant feeding practices, contributing to the promotion of child health.

  9. Positive impact of child feeding training program for primary care health professionals: a cluster randomized field trial.

    Science.gov (United States)

    Vitolo, Márcia Regina; Louzada, Maria Laura da Costa; Rauber, Fernanda

    2014-12-01

    To assess the impact of a child feeding training program for primary care health professionals about breastfeeding and complementary feeding practices. Cluster-randomized field trial conducted in the city of Porto Alegre, (RS), Brazil. Twenty primary health care centers (HCC) were randomized into intervention (n = 9) and control (n = 11) groups. The health professionals (n = 200) at the intervention group centers received training about healthy feeding practices. Pregnant women were enrolled at the study. Up to six months of child's age, home visits were made to obtain variables related to breastfeeding and introduction of foods. 619 children were evaluated: 318 from the intervention group and 301 from the control group. Exclusive breastfeeding prevalence in the first (72.3 versus 59.4%; RR = 1.21; 95%CI 1.08 - 1.38), second (62.6 versus 48.2%; RR = 1.29; 95%CI 1.10 - 1.53), and third months of life (44.0% versus 34.6%; RR = 1.27; 95%CI 1.04 - 1.56) was higher in the intervention group compared to the control group. The prevalence of children who consumed meat four or five times per week was higher in the intervention group than in the control group (36.8 versus 22.6%; RR = 1.62; 95%CI 1.32 - 2.03). The prevalence of children who had consumed soft drinks (34.9 versus 52.5%; RR = 0.66; 95%CI 0.54 - 0.80), chocolate (24.5 versus 36.7% RR = 0.66 95%CI 0.53 - 0.83), petit suisse (68.9 versus 79.7; 95%CI 0.75 - 0.98) and coffee (10.4 versus 20.1%; RR = 0.51; 95%CI 0.31 - 0.85) in their six first months of life was lower in the intervention group. The training of health professionals had a positive impact on infant feeding practices, contributing to the promotion of child health.

  10. Conference on "Multidisciplinary approaches to nutritional problems". Postgraduate Symposium. Exploiting dietary supplementation trials to assess the impact of the prenatal environment on CVD risk.

    Science.gov (United States)

    Hawkesworth, Sophie

    2009-02-01

    Animal studies have demonstrated that altering the maternal diet during pregnancy affects offspring disease risk. Data from human subjects on the early-life determinants of disease have been derived primarily from birth-weight associations; studies of the impact of the maternal diet are scarce and inconsistent. Investigating CVD risk factors in the offspring of women who have participated in maternal supplementation trials provides a useful resource in this research field, by virtue of employing an experimental design (as compared with observational studies). To date, follow-up studies have been published only for a small number of trials; these trials include the impact of maternal protein-energy, multiple-micronutrient and Ca supplementation on offspring disease risk. In Nepal maternal micronutrient supplementation has been shown to be associated with lower offspring systolic blood pressure at 2 years of age. Data from Guatemala on a pre- and postnatal protein-energy community intervention have suggested long-term improvements in fasting glucose and body composition but not in blood pressure. In The Gambia no association has been found between prenatal protein-energy supplementation and markers of CVD risk including body composition, blood pressure and fasting glucose and insulin in childhood and adolescence. Little evidence of an effect of maternal Ca supplementation on offspring blood pressure has been demonstrated in four trials, although the risk of high systolic blood pressure was found to be reduced in one trial. The present paper reviews the current evidence relating maternal nutritional supplementation during pregnancy to offspring CVD risk and explores the potential explanations for the lack of association.

  11. Leveraging management information in improving call centre productivity

    Directory of Open Access Journals (Sweden)

    Manthisana Mosese

    2016-04-01

    Full Text Available Background: The availability and efficient use of management information is one of the key strategic levers in driving growth and competitiveness for companies. Management information facilitates vital decision making that assists organisations in improving their competitiveness. For call centre operations, competitiveness entails improving productivity and customer service, and management information is essential in this endeavour.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

  12. Outcomes of inoperable symptomatic aortic stenosis patients not undergoing aortic valve replacement: insight into the impact of balloon aortic valvuloplasty from the PARTNER trial (Placement of AoRtic TraNscathetER Valve trial).

    Science.gov (United States)

    Kapadia, Samir; Stewart, William J; Anderson, William N; Babaliaros, Vasilis; Feldman, Ted; Cohen, David J; Douglas, Pamela S; Makkar, Raj R; Svensson, Lars G; Webb, John G; Wong, S Chiu; Brown, David L; Miller, D Craig; Moses, Jeffrey W; Smith, Craig R; Leon, Martin B; Tuzcu, E Murat

    2015-02-01

    The aim of this report is to characterize the impact of balloon aortic valvuloplasty (BAV) in patients not undergoing aortic valve replacement in the PARTNER (Placement of AoRtic TraNscathetER Valves) trial. The PARTNER trial is the only randomized trial with independently adjudicated data of inoperable severe symptomatic aortic stenosis patients, allowing outcome analysis of unoperated-on patients. The design and initial results of the PARTNER trial (Cohort B) were reported previously. After excluding patients with pre-randomization BAV, we compared patients undergoing BAV within 30 days of randomization (BAV group) with those not having BAV within 30 days of randomization (no BAV group) to characterize the use and impact of BAV. In the PARTNER Cohort B study, 179 inoperable patients were randomized to standard treatment including 39 patients (21.8%) who had undergone a BAV before randomization (previous BAV group). Of the 140 patients who did not have BAV before enrollment in the study, 102 patients (73%) had BAV within 30 days of study randomization (BAV group). Survival at 3 months was greater in the BAV group compared with the no BAV group (88.2%; 95% confidence interval [CI]: 82.0% to 94.5% vs. 73.0%; 95% CI: 58.8% to 87.4%). However, survival was similar at 6-month follow-up (74.5%; 95% CI: 66.1% to 83.0% vs. 73.1%; 58.8% to 87.4%). There was improvement in quality of life parameters when paired comparisons were made between baseline and 30 days and 6 months between the BAV and no BAV groups, but this effect was lost at 12-month follow-up. BAV improves functional status and survival in the short term, but these benefits are not sustained. BAV for aortic stenosis patients who cannot undergo aortic valve replacement is a useful palliative therapy. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

    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

  14. Collaborative treatment of late-life depression in primary care (GermanIMPACT): study protocol of a cluster-randomized controlled trial.

    Science.gov (United States)

    Wernher, Iris; Bjerregaard, Frederike; Tinsel, Iris; Bleich, Christiane; Boczor, Sigrid; Kloppe, Thomas; Scherer, Martin; Härter, Martin; Niebling, Wilhelm; König, Hans-Helmut; Hüll, Michael

    2014-09-06

    Depression is not a normal side effect of aging, however it is one of the most prevalent mental health issues in later life, imposing a tremendous burden on patients, their families, and the healthcare system. We describe the experimental implementation of a collaborative, stepped-care model for the treatment of late-life depression (GermanIMPACT trial) in the German primary care context. GermanIMPACT was developed as an adaptation of a successful and widely used American model. The aim of the study is to evaluate the model's applicability to the German primary care setting and its cost-effectiveness. The study will be conducted as a cluster-randomized controlled trial comparing the development of depressive symptoms in primary care patients who either receive treatment as usual (control arm) or treatment according to the GermanIMPACT model (intervention arm). In two German cities (Freiburg and Hamburg), a total of 60 general practice offices will be selected and randomized. Each general practice office will be asked to enroll five patients into the trial who are 60 years of age or older and who show moderate depressive symptoms in the scope of a diagnosed depressive episode, recurrent depressive disorder, or dysthymia. General practices in the control arm will provide treatment as usual; general practices in the intervention arm will work closely with a specially trained care manager and a supervising mental health specialist. Evidence-based elements of the treatment plan manual include patient education, identification and integration of positive activities into the daily routine, relapse prevention, and training of problem-solving techniques as needed. The intervention period per patient will be one year. Data will be collected at baseline, 6, and 12 months. Primary outcome is the patient-reported change of depressive symptoms (Patient Health Questionnaire, PHQ-9). Secondary outcomes include measures of quality of life, anxiety, depression-related behavior

  15. Impact of improved recording of work-relatedness in primary care visits at occupational health services on sickness absences: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Atkins, Salla; Ojajärvi, Ulla; Talola, Nina; Viljamaa, Mervi; Nevalainen, Jaakko; Uitti, Jukka

    2017-07-26

    Employment protects and fosters health. Occupational health services, particularly in Finland, have a central role in protecting employee health and preventing work ability problems. However, primary care within occupational health services is currently underused in informing preventive activities. This study was designed to assess whether the recording of work ability problems and improvement of follow-up of work-related primary care visits can reduce sickness absences and work disability pensions after 1 year. A pragmatic trial will be conducted using patient electronic registers and registers of the central pensions agency in Finland. Twenty-two occupational health centres will be randomised to intervention and control groups. Intervention units will receive training to improve recording of work ability illnesses in the primary care setting and improved follow-up procedures. The intervention impact will be assessed through examining rates of sickness absence across intervention and control clinics as well as before and after the intervention. The trial will develop knowledge of the intervention potential of primary care for preventing work disability pensions and sickness absence. The use of routine patient registers and pensions registers to assess the outcomes of a randomised controlled trial will bring forward trial methodology, particularly when using register-based data. If successful, the intervention will improve the quality of occupational health care primary care and contribute to reducing work disability. ISRCTN Registry reference number ISRCTN45728263 . Registered on 18 April 2016.

  16. 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

  17. Chemotherapeutic Impact on Pain and Global Health-Related Quality of Life in Hormone-Refractory Prostate Cancer: Dynamically Modified Outcomes Analysis (DYNAMO) of a Randomized Controlled Trial

    Science.gov (United States)

    Moinpour, Carol M.; Donaldson, Gary W.; Nakamura, Yoshio

    2010-01-01

    Purpose This paper applies the Dynamically Modified Outcomes (DYNAMO) model to a clinical trial of two chemotherapeutic regimens on global health-related quality of life (GHRQL) in hormone-refractory prostate cancer. Methods DYNAMO identifies the causal influences operating in a clinical trial and their mediation, moderation, and modulation by uncontrolled variables. Southwest Oncology Group Trial S9916 randomized assignment to mitoxantrone plus prednisone (M+P) versus docetaxel plus estramustine (D+E) treatments. In this application, we examine baseline-adjusted impacts of Worst Pain (McGill Pain Questionnaire) on GHRQL (EORTC Quality of Life Questionnaire-C30)at 10 weeks. Results Average treatment levels of Pain did not differ, hence the average mediated effect of treatment on GHRQL was zero. Nonetheless, M+P reduced the impact (the relational outcome) of Pain on GHRQL by 54% relative to D+E. Individual variation in the relational outcome (modulation) was of the same magnitude as the average difference between arms. Performance status moderated the direct effects of treatment, with D+E more effective in good, but not poor, performance strata. Conclusions The DYNAMO approach comprehensively accounted for treatment effects. Rather than a single average effect, there were three distinct treatment effects: one direct effect for each performance status level, and a direct effect on the relationship between pain and GHRQL. PMID:19130298

  18. PHARMAID study protocol: Randomized controlled trial to assess the impact of integrated pharmaceutical care at a psychosocial intervention on caregiver's burden in Alzheimer's disease or related diseases.

    Science.gov (United States)

    Novais, T; Moutet, C; Delphin-Combe, F; Dauphinot, V; Colin, C; Krolak-Salmon, P; Mouchoux, C

    2017-02-01

    Alzheimer's Disease and Related Diseases (ADRD) are associated with a caregiver burden that increases with the progression of the disease. Psychosocial interventions reported a moderate improvement on caregivers' burden. Patients with ADRD and their older caregivers are also exposed to a higher risk of developing drug-related problems. The main objective of the PHARMAID study is to measure the impact of personalized pharmaceutical collaborative care integrated to a multidisciplinary psychosocial program on the burden of caregivers. The PHARMAID study is a 18-month randomized controlled trial that started in September 2016. This paper describes the study protocol. PHARMAID plans to enroll 240 dyads, i.e. ADRD patients and caregivers, whose inclusion criteria are: outpatient with mild or major neurocognitive disorders due to ADRD, living at home, receiving support from a family caregiver. Three parallel groups will compare a control group with two experimental groups: psychosocial intervention and integrated pharmaceutical care at a psychosocial intervention. The main outcome is the caregiver's burden assessed by the Zarit Burden Index at 6, 12 and 18months. This is the first trial designed to assess the specific impact of the integration of pharmaceutical care in a multidisciplinary psychosocial program on the caregiver's burden. The results will inform policymakers on strategies to implement in the near future. [ClinicalTrials.gov: NCT02802371] Registered in June 2016. Copyright © 2016 Elsevier Inc. All rights reserved.

  19. 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.

  20. 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.

  1. 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.

  2. 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.  

  3. 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

  4. 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.

  5. 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.

  6. ICALL's Relevance to CALL

    Science.gov (United States)

    Ward, Monica

    2017-01-01

    The term Intelligent Computer Assisted Language Learning (ICALL) covers many different aspects of CALL that add something extra to a CALL resource. This could be with the use of computational linguistics or Artificial Intelligence (AI). ICALL tends to be not very well understood within the CALL community. There may also be the slight fear factor…

  7. Impact of Non-Infarct-Related Artery Disease on Infarct Size and Outcomes (from the CRISP-AMI Trial).

    Science.gov (United States)

    Shah, Rohan; Clare, Robert M; Chiswell, Karen; Jones, W Schuyler; Kumar, A Sreenivas; Thiele, Holger; Smalling, Richard W; Chandra, Praveen; Cohen, Marc; Perera, Divaka; Chew, Derek P; French, John K; Blaxill, Jonathan; Ohman, E Magnus; Patel, Manesh R

    2016-12-01

    Non-infarct-related artery (non-IRA) disease is prevalent in patients with ST-segment elevation myocardial infarction (STEMI). We aimed to assess the impact of non-IRA disease on infarct size and clinical outcomes in patients with acute STEMI. The Counterpulsation to Reduce Infarct Size Pre-PCI Acute Myocardial Infarction (CRISP-AMI) trial randomized patients to intra-aortic balloon counterpulsation (IABC) vs no IABC prior to percutaneous coronary intervention in patients with acute STEMI. Infarct size (% left ventricular mass) at 3-5 days post percutaneous coronary intervention and 6-month clinical outcomes were compared between patients with and without non-IRA disease (defined as ≥50% stenosis in at least one non-IRA). A total of 324 (96.1%) patients had anterior STEMI, of whom 34.9% had non-IRA disease. There was no difference in infarct size (% left ventricular mass) between patients with and without non-IRA disease (median 39% vs 39%; P = .73). At 6 months, there was no difference in rates of recurrent myocardial infarction (0.9% vs 0.9%; P = .78), major Thrombolysis In Myocardial Infarction bleeding (0.9% vs 0.5%; P = .77), or all-cause death (3.5% vs 2.4%; P = .61) in patients with and without non-IRA disease, respectively. Patients with non-IRA disease had a higher rate of new/worsening heart failure with hospitalization (8.8% vs 1.9%; P = .0050). More than one-third of patients with anterior STEMI in the CRISP-AMI study had non-IRA disease. These patients had similar infarct sizes and rates of recurrent myocardial infarction, major bleeding, and all-cause death. Patients with non-IRA disease did have a higher rate of new/worsening heart failure with hospitalization. Further study is needed to understand the mechanisms of outcomes of patients with non-IRA disease. Copyright © 2016 Elsevier Inc. All rights reserved.

  8. What Can Be Learned from Existing Investigations of Weight-Related Practices and Policies with the Potential to Impact Disparities in US Child-Care Settings? A Narrative Review and Call for Surveillance and Evaluation Efforts.

    Science.gov (United States)

    Larson, Nicole; Ayers Looby, Anna; Frost, Natasha; Nanney, Marilyn S; Story, Mary

    2017-10-01

    Child-care settings and the combination of policies and regulations under which they operate may reduce or perpetuate disparities in weight-related health, depending on the environmental supports they provide for healthy eating and activity. The objectives of this review are to summarize research on state and local policies germane to weight-related health equity among young children in the United States and on how federal policies and regulations may provide supports for child-care providers serving families with the most limited resources. In addition, a third objective is to comprehensively review studies of whether there are differences in practices and policies within US child-care facilities according to the location or demographics of providers and children. The review found there is growing evidence addressing disparities in the social and physical child-care environments provided for young children, but scientific gaps are present in the current understanding of how resources should best be allocated and policies designed to promote health equity. Additional research is needed to address limitations of prior studies relating to the measurement of supports for weight-related health; complexities of categorizing socioeconomic position, ethnicity/race, and urban and rural areas; exclusion of legally nonlicensed care settings from most research; and the cross-sectional nature of most study designs. There is a particularly great need for the development of strong surveillance systems to allow for better monitoring and evaluation of state policies that may impact weight-related aspects of child-care environments, implementation at the program level, and needed implementation supports. Copyright © 2017 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

  9. Calling behavior of blue and fin whales off California

    Science.gov (United States)

    Oleson, Erin Marie

    Passive acoustic monitoring is an effective means for evaluating cetacean presence in remote regions and over long time periods, and may become an important component of cetacean abundance surveys. To use passive acoustic recordings for abundance estimation, an understanding of the behavioral ecology of cetacean calling is crucial. In this dissertation, I develop a better understanding of how blue (Balaenoptera musculus) and fin (B. physalus ) whales use sound with the goal of evaluating passive acoustic techniques for studying their populations. Both blue and fin whales produce several different call types, though the behavioral and environmental context of these calls have not been widely investigated. To better understand how calling is used by these whales off California I have employed both new technologies and traditional techniques, including acoustic recording tags, continuous long-term autonomous acoustic recordings, and simultaneous shipboard acoustic and visual surveys. The outcome of these investigations has led to several conclusions. The production of blue whale calls varies with sex, behavior, season, location, and time of day. Each blue whale call type has a distinct behavioral context, including a male-only bias in the production of song, a call type thought to function in reproduction, and the production of some calls by both sexes. Long-term acoustic records, when interpreted using all call types, provide a more accurate measure of the local seasonal presence of whales, and how they use the region annually, seasonally and daily. The relative occurrence of different call types may indicate prime foraging habitat and the presence of different segments of the population. The proportion of animals heard calling changes seasonally and geographically relative to the number seen, indicating the calibration of acoustic and visual surveys is complex and requires further study on the motivations behind call production and the behavior of calling whales

  10. Bonobos extract meaning from call sequences.

    Directory of Open Access Journals (Sweden)

    Zanna Clay

    Full Text Available Studies on language-trained bonobos have revealed their remarkable abilities in representational and communication tasks. Surprisingly, however, corresponding research into their natural communication has largely been neglected. We address this issue with a first playback study on the natural vocal behaviour of bonobos. Bonobos produce five acoustically distinct call types when finding food, which they regularly mix together into longer call sequences. We found that individual call types were relatively poor indicators of food quality, while context specificity was much greater at the call sequence level. We therefore investigated whether receivers could extract meaning about the quality of food encountered by the caller by integrating across different call sequences. We first trained four captive individuals to find two types of foods, kiwi (preferred and apples (less preferred at two different locations. We then conducted naturalistic playback experiments during which we broadcasted sequences of four calls, originally produced by a familiar individual responding to either kiwi or apples. All sequences contained the same number of calls but varied in the composition of call types. Following playbacks, we found that subjects devoted significantly more search effort to the field indicated by the call sequence. Rather than attending to individual calls, bonobos attended to the entire sequences to make inferences about the food encountered by a caller. These results provide the first empirical evidence that bonobos are able to extract information about external events by attending to vocal sequences of other individuals and highlight the importance of call combinations in their natural communication system.

  11. 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 non-heat-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 CIT compared with PLC trial (p p 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) occurred. 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 CIT than in PLC trial. Compared with pre-DE time point, PV had decreased to a lower level in PLC than in 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.

  12. From Systematic Review to Call for Action.

    Science.gov (United States)

    Sawin, Erika Metzler; Sobel, Linda L; Annan, Sandra L; Schminkey, Donna L

    2017-06-01

    Intimate partner violence (IPV) is a global public health and criminal justice concern with significant impacts; especially high rates are seen among rural Hispanic American (HA) communities, the fastest growing population in the United States. They experience additional barriers to care including extreme poverty, lesser education, gender norms, and language and immigration issues. A systematic literature review was conducted using Cooper's framework to identify evidence supporting associations between interventions and prevention, reduction, and elimination of IPV among rural HA women. Searches conducted on databases including CINAHL, PubMed, Medline, Women's Studies International, MedicLatina, and JSTOR used the MeSH terms Hispanic Americans (Latino/a and Hispanic), domestic violence, and intimate partner violence. Selected studies were published between January 1, 2000, and January 1, 2014. Of the 617 yielded articles, only 6 met the inclusion criteria. Of these, none closely examined rurality or provided valid and reliable measures of outcomes, instead reporting program descriptions and suggested interventions. We identify key findings to guide program, screening, and tool development. Our study identifies a gap in knowledge, research, and effective practices and issues a call for action to create evidence-based tools to prevent, reduce, and eliminate IPV in these underserved populations.

  13. Neurocognitive effects following an overnight call shift on faculty anesthesiologists.

    Science.gov (United States)

    Chang, L C; Mahoney, J J; Raty, S R; Ortiz, J; Apodaca, S; De La Garza, R

    2013-09-01

    The impact of sleep deprivation on neurocognitive performance is a significant concern to both the health of patients and to the physicians caring for them, as demonstrated by the Accreditation Council for Graduate Medical Education enforced resident work hours. This study examined the effects of an overnight call at a level 1 trauma hospital on neurocognitive performance of faculty anesthesiologists. Eleven faculty anesthesiologists completed a series of computerized tests that were designed to evaluate different areas of neurocognition, such as working memory, verbal learning, and concentration. The anesthesiologists completed the tests following an overnight call in the morning at 6:30 and again following a normal night's rest at 6:30 on a different date. Within-subjects, repeated measures analysis of variance revealed a significant difference on post-call vs. control performance on measures of learning and memory (P = 0.04). However, there were no significant differences on performance on measures of working memory or sustained attention and vigilance. Pre-call vs. control performances were also evaluated, but no significant differences were detected. Following a night call shift, performance on learning and memory was significantly reduced. Other areas were not significantly affected, which may have been due to certain possibilities, such as practice effect or variability in the call shifts. The real-world relevance of the decline in performance on these measures remains unclear. © 2013 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  14. Immediate intensive mobilization compared with immediate conventional mobilization for the impacted osteoporotic conservatively treated proximal humeral fracture: a randomized controlled trial.

    Science.gov (United States)

    Carbone, S; Razzano, C; Albino, P; Mezzoprete, R

    2017-12-01

    To select in a 2-year survey of proximal humerus fractures accessing the emergency department, a population of osteoporotic stable impacted fractures and to randomize them into two groups, one with an immediate intensive mobilization program and the other with an immediate conventional mobilization program. In emergency department, patients with clinical signs of shoulder girdle fracture were submitted to standard X-ray examination and CT scan. Patients with stable (absence of metaphyseal comminution or fifth fragment) osteoporotic (cortical bone thickness lower than 6 mm) impacted (Is any part of metaphysis or head impacted into the shaft? YES/NO) proximal humerus fractures were selected for randomization in one of the two groups. Group 1: early intensive mobilization; Group 2: early conventional mobilization. Functional and radiographic assessment was recorded at 3, 6 and 12 months of follow-up. In the considered period, 120 patients were affected by a stable impacted osteoporotic proximal humerus fracture. At the final follow-up, 36 patients in group 1 and 39 patients in group 2 were available for statistical analysis. Functional and radiographic scores were comparable, with a trend of significance in favor of group 2. No fracture in any of the group showed significant loss of reduction respect to 6 months of follow-up. 4 (10%) and 1 (2.5%) patients in groups 1 and 2 were not compliant with the rehabilitation program (p = 0.037). This randomized controlled trial showed that impacted osteoporotic proximal humerus fractures can be managed non-operatively with an early conventional rehabilitation program composed by 10 sessions of passive motion twice a week, followed by recovery of active range of motion for further 10 sessions thrice a week, while no advantage is given by a more aggressive rehabilitation regimen. Self-assisted exercises should be explained to patients to maximize the effects of the assisted program. Level 1, randomized controlled double

  15. 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.

  16. Impact of the early reduction of cyclosporine on renal function in heart transplant patients: a French randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Boissonnat Pascale

    2012-12-01

    Full Text Available Abstract Background Using reduced doses of Cyclosporine A immediately after heart transplantation in clinical trials may suggest benefits for renal function by reducing serum creatinine levels without a significant change in clinical endpoints. However, these trials were not sufficiently powered to prove clinical outcomes. Methods In a prospective, multicentre, open-label, parallel-group controlled trial, 95 patients aged 18 to 65 years old, undergoing de novo heart transplantation were centrally randomised to receive either a low (130  Results At 12 months, the mean (± SD creatinine value was 120.7 μmol/L (± 35.8 in the low-dose group and 132.3 μmol/L (± 49.1 in the standard-dose group (P = 0.162. Post hoc analyses suggested that patients with higher creatinine levels at baseline benefited significantly from the lower Cyclosporine A target. The number of patients with at least one rejection episode was not significantly different but one patient in the low-dose group and six in the standard-dose group required dialysis. Conclusions In patients with de novo cardiac transplantation, early Cyclosporine A dose reduction was not associated with renal benefit at 12 months. However, the strategy may benefit patients with high creatinine levels before transplantation. Trial registration ClinicalTrials.gov NCT00159159

  17. Impact of withholding early parenteral nutrition completing enteral nutrition in pediatric critically ill patients (PEPaNIC trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Fivez, Tom; Kerklaan, Dorian; Verbruggen, Sascha; Vanhorebeek, Ilse; Verstraete, Sören; Tibboel, Dick; Guerra, Gonzalo Garcia; Wouters, Pieter J; Joffe, Ari; Joosten, Koen; Mesotten, Dieter; Van den Berghe, Greet

    2015-05-01

    The state-of-the-art nutrition used for critically ill children is based essentially on expert opinion and extrapolations from adult studies or on studies in non-critically ill children. In critically ill adults, withholding parenteral nutrition (PN) during the first week in ICU improved outcome, as compared with early supplementation of insufficient enteral nutrition (EN) with PN. We hypothesized that withholding PN in children early during critical illness reduces the incidence of new infections and accelerates recovery. The Pediatric Early versus Late Parenteral Nutrition in Intensive Care Unit (PEPaNIC) study is an investigator-initiated, international, multicenter, randomized controlled trial (RCT) in three tertiary referral pediatric intensive care units (PICUs) in three countries on two continents. This study compares early versus late initiation of PN when EN fails to reach preset caloric targets in critically ill children. In the early-PN (control, standard of care) group, PN comprising glucose, lipids and amino acids is administered within the first days to reach the caloric target. In the late-PN (intervention) group, PN completing EN is only initiated beyond PICU-day 7, when EN fails. For both study groups, an early EN protocol is applied and micronutrients are administered intravenously. The primary assessor-blinded outcome measures are the incidence of new infections during PICU-stay and the duration of intensive care dependency. The sample size (n = 1,440, 720 per arm) was determined in order to detect a 5% absolute reduction in PICU infections, with at least 80% 1-tailed power (70% 2-tailed) and an alpha error rate of 5%. Based on the actual incidence of new PICU infections in the control group, the required sample size was confirmed at the time of an a priori- planned interim-analysis focusing on the incidence of new infections in the control group only. Clinical evidence in favor of early administration of PN in critically ill children is

  18. "Cold calling" in psychiatric follow up studies: is it justified?

    Science.gov (United States)

    Tyrer, P; Seivewright, H; Ferguson, B; Johnson, T

    2003-08-01

    The ethics of cold calling-visiting subjects at home without prior appointment agreed-in follow up research studies has received little attention although it is perceived to be quite common. We examined the ethical implications of cold calling in a study of subjects with defined neurotic disorders followed up 12 years after initial assessment carried out to determine outcome in terms of symptoms, social functioning, and contact with health services. The patients concerned were asked at original assessment if they would agree to be followed up subsequently and although they agreed no time limit was put on this. To decide if cold calling was ethically justifiable and, if so, to set guidelines for researchers. The study was a cohort study of patients with neurotic disorder treated initially for 10 weeks in a randomised controlled trial. At follow up by a research medical practitioner 18 of the 210 patients had died and of the remaining 192 patients 186 (97%) were seen or had a telephone interview. Four patients refused and two others did not have interviews but agreed to some data being obtained. However, only 104 patients (54%) responded to letters inviting them to make an appointment or to refuse contact and the remainder were followed up by cold calling, with most patients agreeing readily to the research interview. The findings illustrate the dilemma of the need to get the maximum possible data from such studies to achieve scientific validity (and thereby justify the ethics of the study) and the protection of subjects' privacy and autonomy. More attention needs to be paid to consent procedures if cold calling is to be defended on ethical grounds but it is unreasonable to expect this to be obtained at the beginning of a research study in a way that satisfies the requirements for informed consent. A suggested way forward is to obtain written consent for the research at the time that cold calling takes place before beginning the research.

  19. Impact of the Dapivirine Vaginal Ring on Sexual Experiences and Intimate Partnerships of Women in an HIV Prevention Clinical Trial: Managing Ring Detection and Hot Sex.

    Science.gov (United States)

    Laborde, Nicole D; Pleasants, Elizabeth; Reddy, Krishnaveni; Atujuna, Millicent; Nakyanzi, Teopista; Chitukuta, Miria; Naidoo, Sarita; Palanee-Phillips, Thesla; Baeten, Jared M; Montgomery, Elizabeth T

    2017-11-18

    Vaginally-inserted HIV prevention methods have been reported to impact the sexual experience for women and their partners, and hence impacts acceptability of and adherence to the method. We analyzed in-depth interviews and focus group discussions about participants' sexual experiences while wearing the ring, collected during the MTN-020/ASPIRE phase 3 safety and effectiveness trial of a dapivirine vaginal ring for HIV prevention in Malawi, South Africa, Uganda, and Zimbabwe. Most women reported that partners did not feel the ring during sex, however, women felt they had to manage their partners' interaction with or reaction to the ring. In maintaining positive relationships, women were concerned about partners' discovering ring use and about ensuring that partners had a good sexual experience with them. Finally women were concerned about how they themselves experienced sex with the ring. Some found that the ring made the vaginal environment more desirable for their partners and themselves.

  20. Impact of Laboratory Charge Display Within the Electronic Health Record Across an Entire Academic Medical Center: Results of a Randomized Controlled Trial.

    Science.gov (United States)

    Schmidt, Robert L; Colbert-Getz, Jorie M; Milne, Caroline K; Vargo, Daniel J; Hussong, Jerry W; Hoidal, John R; Markewitz, Boaz A; Walker, Brandon S; Kawamoto, Kensaku

    2017-11-20

    To determine the impact of systemwide charge display on laboratory utilization. This was a randomized controlled trial with a baseline period and an intervention period. Tests were randomized to a control arm or an active arm. The maximum allowable Medicare reimbursement rate was displayed for tests in the active arm during the intervention period. Total volume of tests in the active arm was compared with those in the control arm. Residents were surveyed before and after the intervention to assess charge awareness. Charge display had no effect on order behavior. This result held for patient type (inpatient vs outpatient) and for insurance category (commercial, government, self-pay). Residents overestimated the charges of tests both before and after the intervention. Many residents failed to notice the charge display in the computerized order entry system. The impact of charge display depends on context. Charge display is not always effective.

  1. Impact of different exercise training modalities on the coronary collateral circulation and plaque composition in patients with significant coronary artery disease (EXCITE trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Uhlemann Madlen

    2012-09-01

    patients with significant CAD compared to a sedentary control group. It also examines the impact of two intensities of ET on the CBF as well as the histological plaque composition. The trial started recruitment in June 2009 and will complete recruitment until June 2012. First results are expected in December 2012 (4-week follow-up, final results (12-month long-term secondary endpoint in December 2013. Trial registration Clinical trial registration information-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01209637

  2. Impact of different exercise training modalities on the coronary collateral circulation and plaque composition in patients with significant coronary artery disease (EXCITE trial): study protocol for a randomized controlled trial

    Science.gov (United States)

    2012-01-01

    significant CAD compared to a sedentary control group. It also examines the impact of two intensities of ET on the CBF as well as the histological plaque composition. The trial started recruitment in June 2009 and will complete recruitment until June 2012. First results are expected in December 2012 (4-week follow-up), final results (12-month long-term secondary endpoint) in December 2013. Trial registration Clinical trial registration information-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01209637 PMID:22974129

  3. Educación de calle

    OpenAIRE

    Aguado Alonso, Carmen María

    2014-01-01

    Los cambios que está sufriendo nuestra sociedad generan nuevas realidades sociales y nuevos métodos de socialización modificando nuestro entorno. Uno de los principales lugares donde ocurre esto es en la calle. La Calle tiene un potencial educativo muy valioso. En ocasiones puede ser utilizado para “des - educar”, olvidado por instituciones sociales, políticas y educativas. Es importante que la Calle se convierta en un espacio de socialización educativa. La Calle tiene un pa...

  4. 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.

  5. Time series modeling of daily abandoned calls in a call centre ...

    African Journals Online (AJOL)

    Models for evaluating and predicting the short periodic time series in daily abandoned calls in a call center are developed. Abandonment of calls due to impatient is an identified problem among most call centers. The two competing models were derived using Fourier series and the Box and Jenkins modeling approaches.

  6. 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.

  7. Impact of Patient Education on Influenza Vaccine Uptake among Community-Dwelling Elderly: A Randomized Controlled Trial

    Science.gov (United States)

    Leung, Ka Chun; Mui, Carlo; Chiu, Wing Yan; Ng, Yuk Yiu; Chen, Matthew H. Y.; Ho, Pui Hung; Kwok, Chun Pong; Lam, Suki S. M.; Wong, Chun Yip; Wong, Kit Yee; Pang, Herbert H.

    2017-01-01

    This randomized controlled trial aimed to test the effectiveness of brief face-to-face patient education in increasing influenza vaccination rate among elderly in the community. Recruitment and intervention were conducted at two general outpatient clinics in Hong Kong. 529 eligible patients were randomly assigned to intervention or control group…

  8. Individual differences in the impact of vicarious racism: African American students react to the George Zimmerman trial.

    Science.gov (United States)

    Mason, Tyler B; Maduro, Ralitsa S; Derlega, Valerian J; Hacker, Desi S; Winstead, Barbara A; Haywood, Jacqueline E

    2017-04-01

    This research focused on how race-based rejection sensitivity (RS-Race) and components of racial identity intensify negative psychological reactions to an incident of vicarious racism. We examined how these individual difference variables directly and/or indirectly predicted African American students' reactions to the trial of George Zimmerman in the killing of the African American teenager, Trayvon Martin. In Study 1, 471 African American students completed measures of RS-Race, thought intrusions about the Zimmerman trial, and outcome variables (negative affect about the Zimmerman trial and forgiveness for Mr. Zimmerman). In Study 2, 304 African American students completed measures of racial identity (centrality, private regard, and public regard), thought intrusions about the Zimmerman trial, negative affect, and forgiveness. In Study 1, higher RS-Race was either directly and/or indirectly (via thought intrusions) related to more negative affect and lower forgiveness. In Study 2, high racial centrality and low public regard either directly and/or indirectly (via thought intrusions) predicted more negative affect and lower forgiveness. RS-Race and specific components of racial identity are likely to sensitize African Americans to incidents of racism that happen to other African Americans, leading to negative psychological reactions when these events occur. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  9. EuroEco (European Health Economic Trial on Home Monitoring in ICD Patients): a provider perspective in five European countries on costs and net financial impact of follow-up with or without remote monitoring.

    Science.gov (United States)

    Heidbuchel, Hein; Hindricks, Gerd; Broadhurst, Paul; Van Erven, Lieselot; Fernandez-Lozano, Ignacio; Rivero-Ayerza, Maximo; Malinowski, Klaus; Marek, Andrea; Romero Garrido, Rafael F; Löscher, Steffen; Beeton, Ian; Garcia, Enrique; Cross, Stephen; Vijgen, Johan; Koivisto, Ulla-Maija; Peinado, Rafael; Smala, Antje; Annemans, Lieven

    2015-01-14

    Remote follow-up (FU) of implantable cardiac defibrillators (ICDs) allows for fewer in-office visits in combination with earlier detection of relevant findings. Its implementation requires investment and reorganization of care. Providers (physicians or hospitals) are unsure about the financial impact. The primary end-point of this randomized prospective multicentre health economic trial was the total FU-related cost for providers, comparing Home Monitoring facilitated FU (HM ON) to regular in-office FU (HM OFF) during the first 2 years after ICD implantation. Also the net financial impact on providers (taking national reimbursement into account) and costs from a healthcare payer perspective were evaluated. A total of 312 patients with VVI- or DDD-ICD implants from 17 centres in six EU countries were randomised to HM ON or OFF, of which 303 were eligible for data analysis. For all contacts (in-office, calendar- or alert-triggered web-based review, discussions, calls) time-expenditure was tracked. Country-specific cost parameters were used to convert resource use into monetary values. Remote FU equipment itself was not included in the cost calculations. Given only two patients from Finland (one in each group) a monetary valuation analysis was not performed for Finland. Average age was 62.4 ± 13.1 years, 81% were male, 39% received a DDD system, and 51% had a prophylactic ICD. Resource use with HM ON was clearly different: less FU visits (3.79 ± 1.67 vs. 5.53 ± 2.32; P financial impact on providers [profit of €408 (327-489) vs. €400 (345-455); range for difference (€-104 to 88), NS], but there was heterogeneity among countries, with less profit for providers in the absence of specific remote FU reimbursement (Belgium, Spain, and the Netherlands) and maintained or increased profit in cases where such reimbursement exists (Germany and UK). Quality of life (SF-36) was not different. For all the patients as a whole, FU-related costs for providers are not

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

    Directory of Open Access Journals (Sweden)

    Winstanley Sarah

    2010-06-01

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

  11. Impact of polymer formulations on neointimal proliferation after zotarolimus-eluting stent with different polymers: insights from the RESOLUTE trial.

    Science.gov (United States)

    Waseda, Katsuhisa; Ako, Junya; Yamasaki, Masao; Koizumi, Tomomi; Sakurai, Ryota; Hongo, Yoichiro; Koo, Bon-Kwon; Ormiston, John; Worthley, Stephen G; Whitbourn, Robert J; Walters, Darren L; Meredith, Ian T; Fitzgerald, Peter J; Honda, Yasuhiro

    2011-06-01

    Polymer formulation may affect the efficacy of drug-eluting stents. Resolute, Endeavor, and ZoMaxx are zotarolimus-eluting stents with different stent platforms and different polymer coatings and have been tested in clinical trials. The aim of this analysis was to compare the efficacy of zotarolimus-eluting stents with different polymers. Data were obtained from the first-in man trial or first randomized trials of each stent, The Clinical RESpOnse EvaLUation of the MedTronic Endeavor CR ABT-578 Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions (RESOLUTE), Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic AVE ABT-578 Eluting Driver Coronary Stent in De Novo Native Coronary Artery Lesions (ENDEAVOR II), and ZoMaxx I trials. Follow-up intravascular ultrasound analyses (8 to 9 months of follow-up) were possible in 353 patients (Resolute: 88, Endeavor: 98, ZoMaxx: 82, Driver: 85). Volume index (volume/stent length) was obtained for vessel, stent, lumen, peristent plaque, and neointima. Cross-sectional narrowing was defined as neointimal area divided by stent area (%). Neointima-free frame ratio was calculated as the number of frames without intravascular ultrasound-detectable neointima divided by the total number of frames within the stent. At baseline, vessel, lumen, and peristent plaque volume index were not significantly different among the 4 stent groups. At follow-up, percent neointimal obstruction was significantly lower in Resolute compared with Endeavor, ZoMaxx, and Driver (Resolute: 3.7±4.0, Endeavor: 17.5±10.1, ZoMaxx: 14.6±8.1, Driver: 29.4±17.2%; Ppolymer used in Resolute independently correlated with neointimal suppression among 3 zotarolimus-eluting stents. The different polymer formulations significantly affect the relative amount of neointima for zotarolimus-eluting stents. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00248079.

  12. Opinions and perceptions regarding the impact of new regulatory guidelines: A survey in Indian Clinical Trial Investigators

    Directory of Open Access Journals (Sweden)

    Rashmi Kadam

    2016-01-01

    Full Text Available Background: Clinical research in India experienced dramatic changes with series of stringent guidelines introduced by regulatory authorities. These guidelines posed significant challenges for the clinical trial industry. Objective: To assess the perceptions and opinion of Indian Investigators about the new regulatory guidelines. Methods: We developed a survey questionnaire on recent regulatory guidelines which was hosted on a web portal. Seventy-three investigators from India participated in the survey. Results: Central registration of Ethics Committees (ECs was agreed by 90.1% participants, 76.8% participants agreed to compensation of subjects for study related Serious Adverse Events (SAE's. The compulsion to include government sites in clinical trials was not agreed by 49.3% participants while 21.2% agreed to it. Restriction on a number of trials per investigator was agreed by 49.3% of participants while 40.9% disagreed. Participants (50.7% disagreed to the introduction of audio-video (AV recording of informed consent, 36.6% agreed and 12.7% were neutral. Discussion: Participants observed that post central registration; ECs have improved systems with adequate member composition, functional Standard Operating Procedures, and timely approvals. Participants agreed that compensation of study related SAE's would assure subject protection and safety. The introduction of AV consenting was strongly debated sighting sociocultural issues in the implementation of the same. Conclusion: Participants endorsed guidelines pertaining to the central registration of ECs, SAE related compensation. Restrictions on a number of trials per investigator and AV consenting were debated ardently. The response of the survey participants who are clinical trial investigators in India showed general acceptance, effectiveness and anticipated compliance to the new regulatory guidelines.

  13. Global collaborative networks on meta-analyses of randomized trials published in high impact factor medical journals: a social network analysis.

    Science.gov (United States)

    Catalá-López, Ferrán; Alonso-Arroyo, Adolfo; Hutton, Brian; Aleixandre-Benavent, Rafael; Moher, David

    2014-01-29

    Research collaboration contributes to the advancement of knowledge by exploiting the results of scientific efforts more efficiently, but the global patterns of collaboration on meta-analysis are unknown. The purpose of this research was to describe and characterize the global collaborative patterns in meta-analyses of randomized trials published in high impact factor medical journals over the past three decades. This was a cross-sectional, social network analysis. We searched PubMed for relevant meta-analyses of randomized trials published up to December 2012. We selected meta-analyses (including at least randomized trials as primary evidence source) published in the top seven high impact factor general medical journals (according to Journal Citation Reports 2011): The New England Journal of Medicine, The Lancet, the BMJ, JAMA, Annals of Internal Medicine, Archives of Internal Medicine (now renamed JAMA Internal Medicine), and PLoS Medicine. Opinion articles, conceptual papers, narrative reviews, reviews without meta-analysis, reviews of reviews, and other study designs were excluded. Overall, we included 736 meta-analyses, in which 3,178 authors, 891 institutions, and 51 countries participated. The BMJ was the journal that published the greatest number of articles (39%), followed by The Lancet (18%), JAMA (15%) and the Archives of Internal Medicine (15%). The USA, the UK, and Canada headed the absolute global productivity ranking in number of papers. The 64 authors and the 39 institutions with the highest publication rates were identified. We also found 82 clusters of authors (one group with 55 members and one group with 54 members) and 19 clusters of institutions (one major group with 76 members). The most prolific authors were mainly affiliated with the University of Oxford (UK), McMaster University (Canada), and the University of Bern (Switzerland). Our analysis identified networks of authors, institutions and countries publishing meta-analyses of randomized

  14. 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 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.

  15. A Close Call: An Impacted Knife Injury to the Thorax.

    Science.gov (United States)

    Kaufeld, Tim; Zeckey, Christian; Marquardt, Steffen; Krettek, Christian; Haverich, Axel; Tudorache, Igor

    2016-12-01

    A 21-year-old woman with a history of psychiatric treatment was admitted to the emergency department with self-inflicted stab wounds to the neck, chest, and abdomen as the result of a suicide attempt. Inspection showed a seemingly superficial cut at the jugular fossa. The patient's mother stated that one long ceramic kitchen bread knife was totally embedded in the right thorax. Further diagnostic measures showed the missing kitchen bread knife penetrating the right chest, with the path of insertion starting 2 cm above the right clavicle and the blade in contact with the right hilum and ending next to the seventh thoracic vertebra. Retrieval the object was a challenging problem. Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  16. Impact of statin therapy on plasma leptin concentrations: a systematic review and meta‐analysis of randomized placebo‐controlled trials

    Science.gov (United States)

    Sahebkar, Amirhossein; Giua, Renato

    2016-01-01

    Objectives The effects of statins on insulin sensitivity, metabolic homeostasis and adipokines in humans are controversial. Several studies have investigated the impact of statin therapy on plasma leptin concentrations but the results have been inconsistent. The aim of the present study was to conduct a systematic review and meta‐analysis of available evidence to calculate the effect size of statin therapy in changing serum leptin concentrations. Methods A systematic search in PubMed‐Medline, SCOPUS, Web of Science and Google Scholar databases was performed to identify randomized placebo‐controlled trials investigating the effect of statins on plasma leptin concentrations. A random‐effects model and generic inverse variance method were used for meta‐analysis. Sensitivity analysis, risk‐of‐bias evaluation and publication bias assessment were carried out using standard methods. Random‐effects meta‐regression was used to evaluate the impact of treatment duration on the estimated effect size. Results Six trials, with a total of 425 subjects, met the eligibility criteria. Overall, statin therapy had no significant effect on leptin levels (weighted mean difference −0.32 ng ml–1, 95% confidence nterval: −2.94, 2.30, P = 0.813). This effect was robust in the sensitivity analysis and in subgroup analyses of trials with <12 or ≥12 weeks' duration. There was no association between the duration of statin therapy and changes in plasma leptin levels. Furthermore, there was no differential effect of hydrophilic and lipophilic statins on plasma leptin concentrations. Conclusion Unless more consistent evidence becomes available in the future, the hypothesis of a relationship between statin use and serum leptin concentrations seem to be unfounded. PMID:27509867

  17. The effect of working on-call on stress physiology and sleep: A systematic review.

    Science.gov (United States)

    Hall, Sarah J; Ferguson, Sally A; Turner, Anne I; Robertson, Samuel J; Vincent, Grace E; Aisbett, Brad

    2017-06-01

    On-call work is becoming an increasingly common work pattern, yet the human impacts of this type of work are not well established. Given the likelihood of calls to occur outside regular work hours, it is important to consider the potential impact of working on-call on stress physiology and sleep. The aims of this review were to collate and evaluate evidence on the effects of working on-call from home on stress physiology and sleep. A systematic search of Ebsco Host, Embase, Web of Science, Scopus and ScienceDirect was conducted. Search terms included: on-call, on call, standby, sleep, cortisol, heart rate, adrenaline, noradrenaline, nor-adrenaline, epinephrine, norepinephrine, nor-epinephrine, salivary alpha amylase and alpha amylase. Eight studies met the inclusion criteria, with only one study investigating the effect of working on-call from home on stress physiology. All eight studies investigated the effect of working on-call from home on sleep. Working on-call from home appears to adversely affect sleep quantity, and in most cases, sleep quality. However, studies did not differentiate between night's on-call from home with and without calls. Data examining the effect of working on-call from home on stress physiology were not sufficient to draw meaningful conclusions. Copyright © 2016 Elsevier Ltd. All rights reserved.

  18. 76 FR 17934 - Infrastructure Protection Data Call

    Science.gov (United States)

    2011-03-31

    ... infrastructure and key resources (CIKR). At DHS, this responsibility is managed by IP within NPPD. Beginning in...: Infrastructure Protection Data Call. OMB Number: 1670-NEW. Frequency: On occasion. Affected Public: Federal... SECURITY Infrastructure Protection Data Call AGENCY: National Protection and Programs Directorate, DHS...

  19. Answering the "Call of the Mountain"

    NARCIS (Netherlands)

    Chaves Villegas, Martha

    2016-01-01

    In response to the age of the ‘anthropocene,’ as some authors are calling this epoch in which one single species is disrupting major natural systems (Steffen et al 2011), there are calls for more radical, learning-based sustainability that generates deep transformations in individuals

  20. 17 CFR 31.18 - Margin calls.

    Science.gov (United States)

    2010-04-01

    ... 17 Commodity and Securities Exchanges 1 2010-04-01 2010-04-01 false Margin calls. 31.18 Section 31....18 Margin calls. (a) No leverage transaction merchant shall liquidate a leverage contract because of a margin deficiency without effecting personal contact with the leverage customer. If a leverage...

  1. 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…

  2. Monitoring method call sequences using annotations

    NARCIS (Netherlands)

    B. Nobakht (Behrooz); F.S. de Boer (Frank); M.M. Bonsangue (Marcello); C.P.T. de Gouw (Stijn); M.M. Jaghouri (MohammadMahdi)

    2014-01-01

    htmlabstractIn this paper we introduce JMSeq, a Java-based tool for monitoring sequences of method calls. JMSeq provides a simple but expressive language to specify the observables of a Java program in terms of sequences of possibly nested method calls. Similar to many monitoring-oriented

  3. 78 FR 21891 - Rural Call Completion

    Science.gov (United States)

    2013-04-12

    ... one of two proposed safe harbor provisions. We also propose to prohibit both originating and... these proposed rules, particularly for originating providers whose call-routing practices do not appear... in presentations at the Commission's October 18, 2011 workshop on rural call routing and termination...

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

    Science.gov (United States)

    Simkiss, Douglas E; Snooks, Helen A; Stallard, Nigel; Davies, Shan; Thomas, Marie A; Anthony, Becky; Winstanley, Sarah; Wilson, Lynsey; Stewart-Brown, Sarah

    2010-06-23

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

  5. Prognostic impact of education level of patients with advanced non-small cell lung cancer enrolled in clinical trials.

    Science.gov (United States)

    Di Maio, Massimo; Signoriello, Simona; Morabito, Alessandro; Rossi, Antonio; Maione, Paolo; Piantedosi, Francovito; Bilancia, Domenico; Cigolari, Silvio; Barbera, Santi; Gebbia, Vittorio; Daniele, Bruno; Robbiati, Sergio Federico; Illiano, Alfonso; Ceribelli, Anna; Carrozza, Francesco; Favaretto, Adolfo; Piazza, Elena; Piccirillo, Maria Carmela; Daniele, Gennaro; Giordano, Pasqualina; Costanzo, Raffaele; Sandomenico, Claudia; Rocco, Gaetano; Gallo, Ciro; Perrone, Francesco; Gridelli, Cesare

    2012-06-01

    Socioeconomic status can potentially affect prognosis of cancer patients. Our aim was to describe potential differences in demographic and clinical characteristics, treatment, and survival by education level in patients with advanced non-small cell lung cancer (NSCLC) enrolled in clinical trials of first-line treatment. Individual data of Italian patients with advanced NSCLC (stage IV, or IIIB with supraclavicular nodes or malignant pleural effusion), ECOG performance status (PS) 0-2, enrolled in four phase III randomized trials conducted between 1996 and 2005 were pooled. Information about education was available for 1680 of 1709 patients (98.3%). Patients were divided in two groups according to education level: high (patients with at least high school diploma) or low (those with less than high school diploma). Survival analyses were stratified by treatment arm within trial. There were 312 (19%) and 1368 (81%) patients with high and low education, respectively. Education level was significantly different among birth cohorts, with a time-trend toward higher education level. Patients with high education were significantly younger (median age 65 vs. 70), were less frequently unfit at diagnosis (ECOG PS2 5% vs. 16%), and their tumor type was more frequently adenocarcinoma (47% vs. 37%). Number of treatment cycles received was not significantly different between education groups. Median survival was 9.4 and 7.6 months in high and low education, respectively (p=0.012). At multivariable analysis, female sex, better PS and high education level (Hazard Ratio 0.85, 95%CI 0.73-0.99, p=0.03) were independently associated with longer survival. In Italian patients enrolled in four randomized trials of first-line chemotherapy for advanced NSCLC, high education was significantly more frequent among younger patients, and was associated with lower proportion of PS2 patients. Education level did not significantly affect number of chemotherapy cycles received. Overall survival was

  6. Call Admission Control in Mobile Cellular Networks

    CERN Document Server

    Ghosh, Sanchita

    2013-01-01

    Call Admission Control (CAC) and Dynamic Channel Assignments (DCA) are important decision-making problems in mobile cellular communication systems. Current research in mobile communication considers them as two independent problems, although the former greatly depends on the resulting free channels obtained as the outcome of the latter. This book provides a solution to the CAC problem, considering DCA as an integral part of decision-making for call admission. Further, current technical resources ignore movement issues of mobile stations and fluctuation in network load (incoming calls) in the control strategy used for call admission. In addition, the present techniques on call admission offers solution globally for the entire network, instead of considering the cells independently.      CAC here has been formulated by two alternative approaches. The first approach aimed at handling the uncertainty in the CAC problem by employing fuzzy comparators.  The second approach is concerned with formulation of CAC ...

  7. Source levels of foraging humpback whale calls.

    Science.gov (United States)

    Fournet, Michelle E H; Matthews, Leanna P; Gabriele, Christine M; Mellinger, David K; Klinck, Holger

    2018-02-01

    Humpback whales produce a wide range of low- to mid-frequency vocalizations throughout their migratory range. Non-song "calls" dominate this species' vocal repertoire while on high-latitude foraging grounds. The source levels of 426 humpback whale calls in four vocal classes were estimated using a four-element planar array deployed in Glacier Bay National Park and Preserve, Southeast Alaska. There was no significant difference in source levels between humpback whale vocal classes. The mean call source level was 137 dB RMS re 1 μPa @ 1 m in the bandwidth of the call (range 113-157 dB RMS re 1 μPa @ 1 m), where bandwidth is defined as the frequency range from the lowest to the highest frequency component of the call. These values represent a robust estimate of humpback whale source levels on foraging grounds and should append earlier estimates.

  8. Call Cultures in Orang-Utans?

    Science.gov (United States)

    Wich, Serge A.; Nater, Alexander; Arora, Natasha; Bastian, Meredith L.; Meulman, Ellen; Morrogh-Bernard, Helen C.; Atmoko, S. Suci Utami; Pamungkas, Joko; Perwitasari-Farajallah, Dyah; Hardus, Madeleine E.; van Noordwijk, Maria; van Schaik, Carel P.

    2012-01-01

    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 assist in bridging

  9. Call cultures in orang-utans?

    Directory of Open Access Journals (Sweden)

    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

  10. Assessing the impact of user-centered research on a clinical trial eHealth tool via counterbalanced research design.

    Science.gov (United States)

    Atkinson, Nancy L; Massett, Holly A; Mylks, Christy; McCormack, Lauren A; Kish-Doto, Julia; Hesse, Bradford W; Wang, Min Qi

    2011-01-01

    Informatics applications have the potential to improve participation in clinical trials, but their design must be based on user-centered research. This research used a fully counterbalanced experimental design to investigate the effect of changes made to the original version of a website, http://BreastCancerTrials.org/, and confirm that the revised version addressed and reinforced patients' needs and expectations. Participants included women who had received a breast cancer diagnosis within the last 5 years (N=77). They were randomized into two groups: one group used and reviewed the original version first followed by the redesigned version, and the other group used and reviewed them in reverse order. The study used both quantitative and qualitative measures. During use, participants' click paths and general reactions were observed. After use, participants were asked to answer survey items and open-ended questions to indicate their reactions and which version they preferred and met their needs and expectations better. Overall, the revised version of the site was preferred and perceived to be clearer, easier to navigate, more trustworthy and credible, and more private and safe overall. However, users who viewed the original version last had similar attitudes toward both versions. By applying research findings to the redesign of a website for clinical trial searching, it was possible to re-engineer the interface to better support patients' decisions to participate in clinical trials. The mechanisms of action in this case appeared to revolve around creating an environment that supported a sense of personal control and decisional autonomy.

  11. Impact of contact on adolescents’ mental health literacy and stigma : the SchoolSpace cluster randomised controlled trial.

    OpenAIRE

    Chisholm, K; P Patterson; Torgerson, C; Turner, E.; Jenkinson, D.; Birchwood, M.

    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...

  12. Impact of the early reduction of cyclosporine on renal function in heart transplant patients: a French randomised controlled trial.

    Science.gov (United States)

    Boissonnat, Pascale; Gaillard, Ségolène; Mercier, Catherine; Redonnet, Michel; Lelong, Bernard; Mattei, Marie-Françoise; Mouly-Bandini, Annick; Pattier, Sabine; Sirinelli, Agnès; Epailly, Eric; Varnous, Shaida; Billes, Marc-Alain; Sebbag, Laurent; Ecochard, René; Cornu, Catherine; Gueyffier, François

    2012-12-03

    Using reduced doses of Cyclosporine A immediately after heart transplantation in clinical trials may suggest benefits for renal function by reducing serum creatinine levels without a significant change in clinical endpoints. However, these trials were not sufficiently powered to prove clinical outcomes. In a prospective, multicentre, open-label, parallel-group controlled trial, 95 patients aged 18 to 65 years old, undergoing de novo heart transplantation were centrally randomised to receive either a low (130 Cyclosporine A (200 transplant months along with mycophenolate mofetil and corticosteroids. Participants had a stable haemodynamic status, a serum creatinine level transplants were excluded. The change in serum creatinine level over 12 months was used as the main criterion for renal function. Intention-to-treat analysis was performed on the 95 randomised patients and a mixed generalised linear model of covariance was applied. At 12 months, the mean (± SD) creatinine value was 120.7 μmol/L (± 35.8) in the low-dose group and 132.3 μmol/L (± 49.1) in the standard-dose group (P = 0.162). Post hoc analyses suggested that patients with higher creatinine levels at baseline benefited significantly from the lower Cyclosporine A target. The number of patients with at least one rejection episode was not significantly different but one patient in the low-dose group and six in the standard-dose group required dialysis. In patients with de novo cardiac transplantation, early Cyclosporine A dose reduction was not associated with renal benefit at 12 months. However, the strategy may benefit patients with high creatinine levels before transplantation. ClinicalTrials.gov NCT00159159.

  13. Modeling dropout from adverse event data: impact of dosing regimens across pregabalin trials in the treatment of generalized anxiety disorder.

    Science.gov (United States)

    Lalovic, Bojan; Hutmacher, Matt; Frame, Bill; Miller, Raymond

    2011-05-01

    Dizziness represents a major determinant of dropout in the treatment of generalized anxiety disorder with pregabalin. Titration (dose escalation) regimens based on clinical judgment were implemented to mitigate this adverse event and reduce patient dropout across clinical trials. Dropout is an important treatment failure endpoint, which can be analyzed using time-to-event models that incorporate daily dosing or other time-varying information. A parametric discrete-time dropout model with daily dizziness severity score as a covariate afforded a systematic, model-based assessment of titration dosing strategies, with model predictions evaluated against corresponding nonparametric estimates. A Gompertz hazard function adequately described the decreasing dropout hazard over time for individuals with severe or moderate dizziness and a lower, constant hazard for individuals reporting no dizziness or mild dizziness. Predictive performance of the model was adequate based on external validation with an independent trial and other goodness-of-fit criteria. Prospective simulations highlight the utility of this approach in reducing dropout based on examination of untested titration scenarios for future generalized anxiety disorder or other trials.

  14. 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

  15. High-accuracy Decision of Call-triage by Using Bayesian Network

    Science.gov (United States)

    Yunoki, Shota; Hamagami, Tomoki; Oshige, Kenji; Kawakami, Chihiro; Suzuki, Noriyuki

    A new call-triage system, a key part of emergency support system with stochastic network model is examined. The call-triage is an operation allowing the efficient decision of service grade and dispatching of suitable rescue team service from phone call information. Nowadays, the call-triage is being trialed on a few cities and is achieving an effect. However, there is the issue that if under-triage in which the condition of sick person is estimated more lightly is eliminated, the efficiency is degraded (over-triage). In this report, in order to overcome the issue, the Bayesian network scheme is examined to the call-triage system. The experiments with real call-triage data set results show the Bayesian network achieves precision enhancement.

  16. Explaining the impact of a women's group led community mobilisation intervention on maternal and newborn health outcomes: the Ekjut trial process evaluation

    Directory of Open Access Journals (Sweden)

    Sinha Rajesh

    2010-10-01

    Full Text Available Abstract Background Few large and rigorous evaluations of participatory interventions systematically describe their context and implementation, or attempt to explain the mechanisms behind their impact. This study reports process evaluation data from the Ekjut cluster-randomised controlled trial of a participatory learning and action cycle with women's groups to improve maternal and newborn health outcomes in Jharkhand and Orissa, eastern India (2005-2008. The study demonstrated a 45% reduction in neonatal mortality in the last two years of the intervention, largely driven by improvements in safe practices for home deliveries. Methods A participatory learning and action cycle with 244 women's groups was implemented in 18 intervention clusters covering an estimated population of 114 141. We describe the context, content, and implementation of this intervention, identify potential mechanisms behind its impact, and report challenges experienced in the field. Methods included a review of intervention documents, qualitative structured discussions with group members and non-group members, meeting observations, as well as descriptive statistical analysis of data on meeting attendance, activities, and characteristics of group attendees. Results Six broad, interrelated factors influenced the intervention's impact: (1 acceptability; (2 a participatory approach to the development of knowledge, skills and 'critical consciousness'; (3 community involvement beyond the groups; (4 a focus on marginalized communities; (5 the active recruitment of newly pregnant women into groups; (6 high population coverage. We hypothesize that these factors were responsible for the increase in safe delivery and care practices that led to the reduction in neonatal mortality demonstrated in the Ekjut trial. Conclusions Participatory interventions with community groups can influence maternal and child health outcomes if key intervention characteristics are preserved and tailored to

  17. Improving mood with psychoanalytic and cognitive therapies (IMPACT: a pragmatic effectiveness superiority trial to investigate whether specialised psychological treatment reduces the risk for relapse in adolescents with moderate to severe unipolar depression: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Suckling John

    2011-07-01

    Full Text Available Abstract Background Up to 70% of adolescents with moderate to severe unipolar major depression respond to psychological treatment plus Fluoxetine (20-50 mg with symptom reduction and improved social function reported by 24 weeks after beginning treatment. Around 20% of non responders appear treatment resistant and 30% of responders relapse within 2 years. The specific efficacy of different psychological therapies and the moderators and mediators that influence risk for relapse are unclear. The cost-effectiveness and safety of psychological treatments remain poorly evaluated. Methods/Design Improving Mood with Psychoanalytic and Cognitive Therapies, the IMPACT Study, will determine whether Cognitive Behavioural Therapy or Short Term Psychoanalytic Therapy is superior in reducing relapse compared with Specialist Clinical Care. The study is a multicentre pragmatic effectiveness superiority randomised clinical trial: Cognitive Behavioural Therapy consists of 20 sessions over 30 weeks, Short Term Psychoanalytic Psychotherapy 30 sessions over 30 weeks and Specialist Clinical Care 12 sessions over 20 weeks. We will recruit 540 patients with 180 randomised to each arm. Patients will be reassessed at 6, 12, 36, 52 and 86 weeks. Methodological aspects of the study are systematic recruitment, explicit inclusion criteria, reliability checks of assessments with control for rater shift, research assessors independent of treatment team and blind to randomization, analysis by intention to treat, data management using remote data entry, measures of quality assurance, advanced statistical analysis, manualised treatment protocols, checks of adherence and competence of therapists and assessment of cost-effectiveness. We will also determine whether time to recovery and/or relapse are moderated by variations in brain structure and function and selected genetic and hormone biomarkers taken at entry. Discussion The objective of this clinical trial is to determine

  18. 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...

  19. The impact of routine open nonsuction drainage on fluid accumulation after thyroid surgery: a prospective randomised clinical trial.

    LENUS (Irish Health Repository)

    Neary, Peter M

    2012-01-01

    Thyroid drains following thyroid surgery are routinely used despite minimal supportive evidence. Our aim in this study is to determine the impact of routine open drainage of the thyroid bed postoperatively on ultrasound-determined fluid accumulation at 24 hours.

  20. Design of a trial to evaluate the impact of clinical pharmacists and community health promoters working with African-Americans and Latinos with Diabetes

    Directory of Open Access Journals (Sweden)

    Gerber Ben S

    2012-10-01

    Full Text Available Abstract Background Given the increasing prevalence of diabetes and the lack of patients reaching recommended therapeutic goals, novel models of team-based care are emerging. These teams typically include a combination of physicians, nurses, case managers, pharmacists, and community-based peer health promoters (HPs. Recent evidence supports the role of pharmacists in diabetes management to improve glycemic control, as they offer expertise in medication management with the ability to collaboratively intensify therapy. However, few studies of pharmacy-based models of care have focused on low income, minority populations that are most in need of intervention. Alternatively, HP interventions have focused largely upon low income minority groups, addressing their unique psychosocial and environmental challenges in diabetes self-care. This study will evaluate the impact of HPs as a complement to pharmacist management in a randomized controlled trial. Methods/Design The primary aim of this randomized trial is to evaluate the effectiveness of clinical pharmacists and HPs on diabetes behaviors (including healthy eating, physical activity, and medication adherence, hemoglobin A1c, blood pressure, and LDL-cholesterol levels. A total of 300 minority patients with uncontrolled diabetes from the University of Illinois Medical Center ambulatory network in Chicago will be randomized to either pharmacist management alone, or pharmacist management plus HP support. After one year, the pharmacist-only group will be intensified by the addition of HP support and maintenance will be assessed by phasing out HP support from the pharmacist plus HP group (crossover design. Outcomes will be evaluated at baseline, 6, 12, and 24 months. In addition, program and healthcare utilization data will be incorporated into cost and cost-effectiveness evaluations of pharmacist management with and without HP support. Discussion The study will evaluate an innovative, integrated

  1. 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.

  2. Impact of standard of care treatments and disease variables on outcomes in systemic lupus erythematosus trials: analysis from the Lupus Foundation of America Collective Data Analysis Initiative.

    Science.gov (United States)

    Kalunian, Kenneth Carekin; Kim, Mimi; Xie, Xianhong; Baskaran, Amrutha; Daly, Rossi Paola; Merrill, Joan Tenenbaum

    2016-03-01

    Most clinical trials for systemic lupus erythematosus (SLE) study the efficacy and safety of investigational agents added to variable background immunosuppressants, which has resulted in high response rates in patients treated with placebo plus standard of care (SOC) plus rescue measures. This project compared the impact of different SOC treatments and disease variables on the outcomes of SLE trials. Data were obtained from 981 patients receiving only SOC treatments in three nephritis and three general SLE trials to compare response and flare rates on the basis of the British Isles Lupus Assessment Group (BILAG) index, a measure common to all trials. For subjects enrolled in general SLE trials (n=173), those receiving mycophenolate mofetil (MMF) had more severe baseline disease, included more patients of African descent, and were administered higher baseline steroid doses compared with those receiving azathioprine (AZA) or methotrexate (MTX). BILAG responses at week 12 were MMF 35%, AZA 49%, MTX 34%, and no immunosuppressant (NIS) 65%. At week 52, MMF response rates increased to 41% despite reducing the steroid doses, but fell in all others (p=0.07, adjusted for steroids). Patients with severe disease activity at baseline (SDAB) who were defined as ≥1 BILAG A (severe) organ score had lower response rates to AZA or MTX but higher rates to MMF or NIS. Interim flares were highest with MMF [flares/patient-year (pt-yr)]. For all flares, rates were as follows: AZA 1.24, MMF 1.87, MTX 1.42, and NIS 0.81 and severe flares were as follows: AZA 0.66, MMF 1.29, MTX: 1.20, and NIS 0.55. Interim flares occurred in 71% of MMF-endpoint responders, 54% of AZA, 50% of MTX, and 22% of NIS. Patients with SDAB had more flares than moderate patients in the MMF and MTX groups: MMF: 2.39 vs. 1.03 flares/pt-yr (p=0.01), MTX: 2.33 vs. 0.63 (p=0.0002), severe flares: 1.87 vs. 0.34 for MMF (p=0.0013), 2.13 vs. 0.40 for MTX (p<0.0001). In nephritis trials (n=808), MMF subjects received less

  3. Impact of peer-led quality improvement networks on quality of inpatient mental health care: study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Aimola, Lina; Jasim, Sarah; Tripathi, Neeraj; Tucker, Sarah; Worrall, Adrian; Quirk, Alan; Crawford, Mike J

    2016-09-21

    Quality improvement networks are peer-led programmes in which members of the network assess the quality of care colleagues provide according to agreed standards of practice. These networks aim to help members identify areas of service provision that could be improved and share good practice. Despite the widespread use of peer-led quality improvement networks, there is very little information about their impact. We are conducting a cluster randomized controlled trial of a quality improvement network for low-secure mental health wards to examine the impact of membership on the process and outcomes of care over a 12 month period. Standalone low secure units in England and Wales that expressed an interest in joining the quality improvement network were recruited for the study from 2012 to 2014. Thirty-eight units were randomly allocated to either the active intervention (participation in the network n = 18) or a control arm (delayed participation in the network n = 20). Using a 5 % significance level and 90 % power, it was calculated that a sample size of 60 wards was required taking into account a 10 % drop out. A total of 75 wards were assessed at baseline and 8 wards dropped out the study before the data collection at follow up. Researchers masked to the allocation status of the units assessed all study outcomes at baseline and follow-up 12 months later. The primary outcome is the quality of the physical environment and facilities on the wards. The secondary outcomes are: safety of the ward, patient-rated satisfaction with care and mental well-being, staff burnout, training and supervision. Relative to control wards, it is hypothesized that the quality of the physical environment and facilities will be higher on wards in the active arm of the trial 12 months after randomization. To our knowledge, this is the first randomized evaluation of a peer-led quality improvement network that has examined the impact of participation on both patient-level and

  4. The impact of tutorial strategies on student nurses' accuracy in diagnostic reasoning in different educational settings: a double pragmatic trial in Italy.

    Science.gov (United States)

    Palese, Alvisa; Saiani, Luisa; Brugnolli, Anna; Regattin, Laura

    2008-09-01

    Italian Nursing Faculties use a range of tutorial strategies (laboratory sessions, intensive clinical tutoring, weekly tutoring) aimed to enhance nursing students' diagnostic reasoning: these strategies have different impacts on promoting student critical thinking. By using critical thinking methods, students develop abilities to check, monitor and constantly evaluate the accuracy of the diagnostic reasoning process. However, there is little evidence to show how effective tutorial strategies are on the accuracy of diagnostic reasoning. There is also very little known about the complexity of tutorial strategies because these are made up of several components (e.g. tutor questioning abilities, the value of the setting, the impact of the environment, the expertise of the tutor and the impact of the Faculty's philosophy of learning), tutorial strategies cannot be standardised and depend on multiple factors which are difficult to control. The objective was to establish a relationship between tutorial strategies orientated to enhance critical thinking and the accuracy of diagnostic reasoning (i.e. the number of correct answers given by students on simulated cases in two different nursing education contexts). It was hypothesised that students who had had one laboratory session using intensive tutorial strategies had less probability of making reasoning errors in diagnosing a simulated case than a control group that had weekly tutorials or routine tutoring. A double pragmatic experimental study was adopted involving two Italian Nursing Faculties at universities in Verona and Udine. A total of 144 students in the first year of their Nursing Science Degree course were involved; in Verona, two random groups of 41 students were taken (an intervention group and a control group). Random selections of 39 students for the intervention group and 29 students for a control group were made from the second campus in Udine. Data analysis was conducted comparing student outcomes in the

  5. The ESEP study: Salpingostomy versus salpingectomy for tubal ectopic pregnancy; The impact on future fertility: A randomised controlled trial

    Directory of Open Access Journals (Sweden)

    van Mello Norah M

    2008-06-01

    Full Text Available Abstract Background For most tubal ectopic pregnancies (EP surgery is the treatment of first choice. Whether surgical treatment should be performed conservatively (salpingostomy or radically (salpingectomy in women wishing to preserve their reproductive capacity, is subject to debate. Salpingostomy preserves the tube, but bears the risks of both persistent trophoblast and repeat ipsilateral tubal EP. Salpingectomy, avoids these risks, but leaves only one tube for reproductive capacity. This study aims to reveal the trade-off between both surgical options: whether the potential advantage of salpingostomy, i.e. a better fertility prognosis as compared to salpingectomy, outweighs the potential disadvantages, i.e. persistent trophoblast and an increased risk for a repeat EP. Methods/Design International multi centre randomised controlled trial comparing salpingostomy versus salpingectomy in women with a tubal EP without contra lateral tubal pathology. Hemodynamically stable women with a presumptive diagnosis of tubal EP, scheduled for surgery, are eligible for inclusion. Patients pregnant after in vitro fertilisation (IVF and/or known documented tubal pathology are excluded. At surgery, a tubal EP must be confirmed. Only women with a tubal EP amenable to both interventions and a healthy contra lateral tube are included. Salpingostomy and salpingectomy are performed according to standard procedures of participating hospitals. Up to 36 months after surgery, women will be contacted to assess their fertility status at six months intervals starting form the day of the operation. The primary outcome measure is the occurrence of spontaneous viable intra uterine pregnancy. Secondary outcome measures are persistent trophoblast, repeat EP, all pregnancies including those resulting from IVF and financial costs. The analysis will be performed according to the intention to treat principle. A cost-effectiveness analysis will be performed within a decision

  6. The impact of supported telemetric monitoring in people with type 2 diabetes: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Wild, Sarah; Hanley, Janet; Lewis, Stephanie; McKnight, John; McCloughan, Lucy; Padfield, Paul; Paterson, Mary; Pinnock, Hilary; McKinstry, Brian

    2013-07-06

    Diabetes prevalence is increasing and current methods of management are unsustainable. Effective approaches to supporting self-management are required. The aim of this randomized controlled trial is to establish whether supported telemetric monitoring of glycemic control and blood pressure results in reductions in glycosylated hemoglobin (HbA1c; the primary outcome of a measure of long-term glycemic control) and secondary outcomes of blood pressure and weight among people with poorly controlled diabetes compared to a control group receiving usual care. Design: multi-center, randomized controlled trial with embedded qualitative study. Setting: primary care in Lothian, Kent, Glasgow and Borders regions in the UK. Participants: people with type 2 diabetes and confirmed HbA1c>7.5% (58 mmol/mol). Intervention/comparison: randomization to intervention or control groups will be performed by the Edinburgh Clinical Trials Unit. Participants in the intervention group will be shown how to use blood glucose and blood pressure monitors and weighing scales which use Bluetooth wireless technology to transmit readings via modem to a remote server. These participants will be asked to provide at least twice weekly measurements of morning and evening blood glucose and weekly measurements of weight and blood pressure. Measurements will be checked at least weekly by practice nurses who will contact the patients to adjust therapy according to guidelines and reinforce lifestyle advice. Participants in the control group will receive usual care. All participants will receive an individual education session. Follow-up: measurements will be performed at practices 9 months after randomization by research nurses blinded to allocation. The primary outcome measure is HbA1c and secondary outcomes measure are daytime systolic and diastolic blood pressure, weight and cost per quality-adjusted life year. Analysis: intention-to-treat analyses will be performed. The sample size of 320 participants

  7. Mourning Dove Call-count Survey

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — The Mourning Dove (Zenaida macroura) Call-Count Survey was developed to provide an index to population size and to detect annual changes in mourning dove breeding...

  8. 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.

  9. The impact of rehabilitation using removable partial dentures and functionally orientated treatment on oral health-related quality of life: a randomised controlled clinical trial.

    Science.gov (United States)

    McKenna, Gerald; Allen, P Finbarr; O'Mahony, Denis; Cronin, Michael; DaMata, Cristiane; Woods, Noel

    2015-01-01

    This study aimed to compare two different tooth replacement strategies for partially dentate older patients; namely functionally orientated treatment according to the principles of the shortened dental arch (SDA) and conventional treatment using removable partial dentures (RPDs) using a randomised controlled clinical trial. The primary outcome measure for this study was impact on oral health-related quality of life (OHRQoL) measured using the short form of the oral health impact profile (OHIP-14). Patients aged 65 years and older were randomly allocated to two different treatment groups: the RPD group and the SDA group. For the RPD group each patient was restored to complete arches with cobalt-chromium RPDs used to replace missing teeth. For the SDA group, patients were restored to a premolar occlusion of 10 occluding pairs of natural and replacement teeth using resin bonded bridgework (RBB). OHRQoL was measured using the OHIP-14 questionnaire administered at baseline, 1 month, 6 months and 12 months after treatment intervention. In total, 89 patients completed the RCT: 44 from the RPD group and 45 from the SDA group. Analysis using a mixed model of covariance (ANCOVA) illustrated that treatment according to the SDA concept resulted in significantly better mean OHIP-14 scores compared with RPD treatment (premovable dentures in terms of impact on OHRQoL. Copyright © 2014 Elsevier Ltd. All rights reserved.

  10. Evaluating erroneous offside calls in soccer

    OpenAIRE

    H?ttermann, Stefanie; No?l, Benjamin; Memmert, Daniel

    2017-01-01

    The ability to simultaneously attend to multiple objects declines with increases in the visual angle separating distant objects. We explored whether these laboratory-measured limits on visual attentional spread generalize to a real life context: offside calls by soccer assistant referees. We coded all offside calls from a full year of first division German soccer matches. By determining the x-y coordinates of the relevant players and assistant referee on the soccer field we were able to calcu...

  11. 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.

  12. Determining the impact of 24/7 phone support on hospital readmissions after aortic valve replacement surgery (the AVRre study): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Lie, Irene; Danielsen, Stein Ove; Tønnessen, Theis; Solheim, Svein; Leegaard, Marit; Sandvik, Leiv; Wisløff, Torbjørn; Vangen, Jonny; Røsstad, Tor Henning; Moons, Philip

    2017-05-30

    Patients undergoing surgical aortic valve replacement (sAVR) have high rates of 30-day readmissions. They also report a low health-related quality of life (HRQOL) and elevated anxiety and depression. The aim of the AVRre study is to determine the efficacy and cost of a 24/7 phone-support intervention in reducing post-discharge readmissions after sAVR. The nature of the support is to help patients better understand and self-manage non-urgent symptoms at home. AVRre is a prospective, randomised controlled study comprising 30 days of continuous phone-support intervention and then intermittent follow-up for the first 12 months. Phone call data from and to patients are evaluated qualitatively; thus, the study has a mixed-method design. Two hundred and eighty-six patients, aged >18 years, scheduled for a sAVR - singly or in combination with another procedure - are recruited from locations in southeast Norway. Patients are randomly assigned to the intervention group, who are purposively phone-called individually 2 and 9 days after discharge and offered on-demand 24/7 (around-the-clock) telephone support for 30 days post-discharge. The primary outcome variable is the number of 30-day hospital readmissions. Secondary outcomes are anxiety and depression symptoms, as measured by the Hospital Anxiety and Depression Scale, HRQOL and quality-adjusted life years, measured by the EuroQol (EQ-5D). Intervention and hospital readmission (diagnosis-related groups (DRGs)/length of stay) for the first year after initial discharge from hospital are used for a cost-utility analysis. Standard parametric and non-parametric tests are used for evaluations over time. Analysis of covariance is used to control for possible differences at baseline. Narratives from phone calls are transcribed verbatim and analysed using systematic text condensation. A complex 'around-the-clock' intervention within a university hospital-based setting could be an effective strategy to reduce the high

  13. Partition Decomposition for Roll Call Data

    CERN Document Server

    Leibon, Greg; Rockmore, Daniel N; Savell, Robert

    2011-01-01

    In this paper we bring to bear some new tools from statistical learning on the analysis of roll call data. We present a new data-driven model for roll call voting that is geometric in nature. We construct the model by adapting the "Partition Decoupling Method," an unsupervised learning technique originally developed for the analysis of families of time series, to produce a multiscale geometric description of a weighted network associated to a set of roll call votes. Central to this approach is the quantitative notion of a "motivation," a cluster-based and learned basis element that serves as a building block in the representation of roll call data. Motivations enable the formulation of a quantitative description of ideology and their data-dependent nature makes possible a quantitative analysis of the evolution of ideological factors. This approach is generally applicable to roll call data and we apply it in particular to the historical roll call voting of the U.S. House and Senate. This methodology provides a...

  14. Ethosomal nanocarriers: the impact of constituents and formulation techniques on ethosomal properties, in vivo studies, and clinical trials

    Science.gov (United States)

    Abdulbaqi, Ibrahim M; Darwis, Yusrida; Khan, Nurzalina Abdul Karim; Assi, Reem Abou; Khan, Arshad A

    2016-01-01

    Ethosomal systems are novel lipid vesicular carriers containing a relatively high percentage of ethanol. These nanocarriers are especially designed for the efficient delivery of therapeutic agents with different physicochemical properties into deep skin layers and across the skin. Ethosomes have undergone extensive research since they were invented in 1996; new compounds were added to their initial formula, which led to the production of new types of ethosomal systems. Different preparation techniques are used in the preparation of these novel carriers. For ease of application and stability, ethosomal dispersions are incorporated into gels, patches, and creams. Highly diverse in vivo models are used to evaluate their efficacy in dermal/transdermal delivery, in addition to clinical trials. This article provides a detailed review of the ethosomal systems and categorizes them on the basis of their constituents to classical ethosomes, binary ethosomes, and transethosomes. The differences among these systems are discussed from several perspectives, including the formulation, size, ζ-potential (zeta potential), entrapment efficiency, skin-permeation properties, and stability. This paper gives a detailed review on the effects of ethosomal system constituents, preparation methods, and their significant roles in determining the final properties of these nanocarriers. Furthermore, the novel pharmaceutical dosage forms of ethosomal gels, patches, and creams are highlighted. The article also provides detailed information regarding the in vivo studies and clinical trials conducted for the evaluation of these vesicular systems. PMID:27307730

  15. Ethosomal nanocarriers: the impact of constituents and formulation techniques on ethosomal properties, in vivo studies, and clinical trials.

    Science.gov (United States)

    Abdulbaqi, Ibrahim M; Darwis, Yusrida; Khan, Nurzalina Abdul Karim; Assi, Reem Abou; Khan, Arshad A

    2016-01-01

    Ethosomal systems are novel lipid vesicular carriers containing a relatively high percentage of ethanol. These nanocarriers are especially designed for the efficient delivery of therapeutic agents with different physicochemical properties into deep skin layers and across the skin. Ethosomes have undergone extensive research since they were invented in 1996; new compounds were added to their initial formula, which led to the production of new types of ethosomal systems. Different preparation techniques are used in the preparation of these novel carriers. For ease of application and stability, ethosomal dispersions are incorporated into gels, patches, and creams. Highly diverse in vivo models are used to evaluate their efficacy in dermal/transdermal delivery, in addition to clinical trials. This article provides a detailed review of the ethosomal systems and categorizes them on the basis of their constituents to classical ethosomes, binary ethosomes, and transethosomes. The differences among these systems are discussed from several perspectives, including the formulation, size, ζ-potential (zeta potential), entrapment efficiency, skin-permeation properties, and stability. This paper gives a detailed review on the effects of ethosomal system constituents, preparation methods, and their significant roles in determining the final properties of these nanocarriers. Furthermore, the novel pharmaceutical dosage forms of ethosomal gels, patches, and creams are highlighted. The article also provides detailed information regarding the in vivo studies and clinical trials conducted for the evaluation of these vesicular systems.

  16. Impact of secondary cytoreductive surgery on survival in patients with platinum sensitive recurrent ovarian cancer: analysis of the CALYPSO trial.

    Science.gov (United States)

    Lee, Chee Khoon; Lord, Sarah; Grunewald, Tami; Gebski, Val; Hardy-Bessard, Anne-Claire; Sehouli, Jalid; Woie, Kathrine; Heywood, Mark; Schauer, Christian; Vergote, Ignace; Scambia, Giovanni; Ferrero, Annamaria; Harter, Philipp; Pujade-Lauraine, Eric; Friedlander, Michael

    2015-01-01

    The role of secondary cytoreductive surgery (SCR) in platinum-sensitive recurrent ovarian cancer (ROC) remains controversial. The overall survival (OS) benefits for surgery reported in observational studies may be due to the selection of patients with better prognosis. Using data from the CALYPSO trial, OS of patients who had SCR was compared to those treated with chemotherapy alone. Multivariate analyses were performed to adjust for prognostic factors. We also tested for an interaction between baseline prognostic groupings and the benefit of surgery. Of the 975 patients randomised in CALYPSO, 19% had SCR and 80% had chemotherapy alone. OS was longer for the SCR group than for chemotherapy alone (median, 49.9 vs. 29.7 months; adjusted hazard ratio (HR), 0.68; P = 0.004). For patients with SCR, the 3-year OS was 72% for those with no measurable disease, and 28% if residual tumour was larger than 5 cm. Patients with good prognostic features benefited the most from SCR (HR 0.43; P < 0.001). The benefit of SCR was less in patients with poorer prognostic features (test of trend P < 0.001). SCR was associated with improved OS in platinum-sensitive ROC, particularly in patients with favourable prognostic characteristics. However, these findings may be due to selection bias, and hence randomised trials are still essential. Copyright © 2014 Elsevier Inc. All rights reserved.

  17. Baseline characteristics and treatment of patients in Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure trial (PARADIGM-HF)

    Science.gov (United States)

    McMurray, John J V; Packer, Milton; Desai, Akshay S; Gong, Jianjian; Lefkowitz, Martin; Rizkala, Adel R; Rouleau, Jean L; Shi, Victor C; Solomon, Scott D; Swedberg, Karl; Zile, Michael R

    2014-01-01

    Aim To describe the baseline characteristics and treatment of the patients randomized in the PARADIGM-HF (Prospective comparison of ARNi with ACEi to Determine Impact on Global Mortality and morbidity in Heart Failure) trial, testing the hypothesis that the strategy of simultaneously blocking the renin–angiotensin–aldosterone system and augmenting natriuretic peptides with LCZ696 200 mg b.i.d. is superior to enalapril 10 mg b.i.d. in reducing mortality and morbidity in patients with heart failure and reduced ejection fraction. Methods Key demographic, clinical and laboratory findings, along with baseline treatment, are reported and compared with those of patients in the treatment arm of the Studies Of Left Ventricular Dysfunction (SOLVD-T) and more contemporary drug and device trials in heart failure and reduced ejection fraction. Results The mean age of the 8442 patients in PARADIGM-HF is 64 (SD 11) years and 78% are male, which is similar to SOLVD-T and more recent trials. Despite extensive background therapy with beta-blockers (93% patients) and mineralocorticoid receptor antagonists (60%), patients in PARADIGM-HF have persisting symptoms and signs, reduced health related quality of life, a low LVEF (mean 29 ± SD 6%) and elevated N-terminal-proB type-natriuretic peptide levels (median 1608 inter-quartile range 886–3221 pg/mL). Conclusion PARADIGM-HF will determine whether LCZ696 is more beneficial than enalapril when added to other disease-modifying therapies and if further augmentation of endogenous natriuretic peptides will reduce morbidity and mortality in heart failure and reduced ejection fraction. PMID:24828035

  18. Safety, tolerability, and impact on allergic inflammation of autologous E.coli autovaccine in the treatment of house dust mite asthma - a prospective open clinical trial

    Directory of Open Access Journals (Sweden)

    Schulze Johannes

    2011-06-01

    Full Text Available Abstract Background Asthma is increasing worldwide and results from a complex immunological interaction between genetic susceptibility and environmental factors. Autovaccination with E. coli induces a strong TH-1 immune response, thus offering an option for the treatment of allergic diseases. Methods Prospective open trial on safety, tolerability, and impact on allergic inflammation of an autologous E.coli autovaccine in intermittent or mild persistent house dust mite asthma. Determination of exhaled nitric monoxide (eNO before and after bronchial mite challenge initially and after nine months of autovaccination. Results In nine subjects and a total of 306 injections, we observed 101 episodes of local erythema (33.3%; median of maximal diameter 2.5 cm, 95 episodes of local swelling (31.1%; median of maximal diameter 3 cm, and 27 episodes of local pain (8.8%. Four subjects reported itching at the injection site with a total of 30 episodes (9.8%. Median eNO increase after autovaccination was significantly smaller (from 27.3 to 33.8 ppb; p = 0.334 compared to initial values (from 32.6 to 42.2 ppb; p = 0.046 (p = 0.034. We observed no serious adverse events. All organ functions (inclusive electrocardiogramm and laboratory testing of the blood (clinical chemistry, hematology and the urine (screening test, Β-microglobuline were within normal limits. Vital signs undulated within the physiological variability. Conclusion The administration of autologous autovacine for the treatment of house dust mite asthma resulted in a reduction of the eNO increase upon bronchial mite challenge. In nine subjects and 306 injections, only a few mild local reactions and no systemic severe adverse events were observed. Trial registration EudraCT Nr. 2005-005534-12 ClinicalTrials.gov ID NCT00677209

  19. The impact of regimented aminophylline use on extracardiac radioisotope activity in patients undergoing regadenoson stress SPECT myocardial perfusion imaging: a substudy of the ASSUAGE trial.

    Science.gov (United States)

    Ballany, Wassim; Mansour, Khaled; Morales Demori, Raysa; Al-Amoodi, Mohammed; Doukky, Rami

    2014-06-01

    In patients undergoing regadenoson stress SPECT myocardial perfusion imaging (MPI), the impact of the regimented administration of aminophylline on the cardiac-to-extracardiac photon activity ratio is unknown. This is a substudy of the ASSUAGE trial (NCT01250496); a double-blinded, randomized, placebo-controlled clinical trial which investigated the attenuation of regadenoson-related adverse effects using 75 mg of intravenous aminophylline vs placebo, administered 90 seconds following (99m)Tc-tetrofosmin injection in patients undergoing regadenoson stress SPECT-MPI. In subjects with normal MPI enrolled in the trial, we sampled from the antero-posterior planar projection of the post-stress scintigraphic data the mean photon activity in the myocardium, liver, bowel, and lungs. The mean cardiac-to-extracardiac activity ratios were compared between patients randomized to aminophylline vs placebo. We studied 158 eligible subjects, randomized to receive aminophylline (n = 86) or placebo (n = 72). The means of photon activity ratios of the heart-to-liver, heart-to-bowel, heart-to-lungs, inferior wall of the heart-to-liver, and inferior wall of the heart-to-bowel were not statistically different between those who received aminophylline vs placebo (P values > .30). Only the time lapse between stress (99m)Tc-tetrofosmin injection and stress SPECT acquisition independently correlated with higher heart-to-liver and heart-to-bowel activity ratios (P values ≤ .01). Patients' body mass index independently correlated with lower heart-to-lung ratio (P = .009). The regimented intravenous aminophylline use following regadenoson stress does not significantly improve the cardiac-to-extracardiac photon activity ratio in patients undergoing regadenoson stress (99m)Tc-tetrofosmin SPECT-MPI.

  20. Impact of the Daily Use of a Microcrystal Hydroxyapatite Dentifrice on De Novo Plaque Formation and Clinical/Microbiological Parameters of Periodontal Health. A Randomized Trial

    Science.gov (United States)

    Schlagenhauf, Ulrich; May, Theodor W.; Gravemeier, Martina; Prior, Karola; Petersilka, Gregor; Ehmke, Benjamin

    2016-01-01

    Aim This 12-week prospective, randomized, double-blind, two-center trial evaluated the impact of a microcrystalline zinc hydroxyapatite (mHA) dentifrice on plaque formation rate (PFR) in chronic periodontitis patients. We hypothesized that mHA precipitates cause delayed plaque development when compared to a fluoridated control (AmF/SnF2), and therefore would improve periodontal health. Material & Methods At baseline and after 4 and 12 weeks, PFR and other clinical and microbiological parameters were recorded. Seventy periodontitis patients received a mHA or AmF/SnF2 dentifrice as daily oral care without hygiene instructions