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Sample records for controlled field trial

  1. Field trial of a Caryospora species vaccine for controlling clinical coccidiosis in falcons.

    PubMed

    Forbes, N A; Fox, M T

    2005-01-29

    A Caryospora species vaccine was prepared and used in an attempt to prevent infection and associated morbidity in falcons. A blind field trial was conducted, involving a vaccinated group of 20 birds and two control groups of seven and four birds, which were subsequently challenged with a live mixed-species vaccine. There was a statistically significant reduction in morbidity and shedding of oocysts in the vaccinated group compared with the control groups.

  2. Dosing free nitrous acid for sulfide control in sewers: results of field trials in Australia.

    PubMed

    Jiang, Guangming; Keating, Anthony; Corrie, Shaun; O'halloran, Kelly; Nguyen, Lam; Yuan, Zhiguo

    2013-09-01

    Intermittent dosing of free nitrous acid (FNA), with or without the simultaneous dosing of hydrogen peroxide, is a new strategy developed recently for the control of sulfide production in sewers. Six-month field trials have been carried out in a rising main sewer in Australia (150 mm in diameter and 1080 m in length) to evaluate the performance of the strategy that was previously demonstrated in laboratory studies. In each trial, FNA was dosed at a pumping station for a period of 8 or 24 h, some with simultaneous hydrogen peroxide dosing. The sulfide control effectiveness was monitored by measuring, on-line, the dissolved sulfide concentration at a downstream location of the pipeline (828 m from the pumping station) and the gaseous H2S concentration at the discharge manhole. Effective sulfide control was achieved in all nine consecutive trials, with sulfide production reduced by more than 80% in 10 days following each dose. Later trials achieved better control efficiency than the first few trials possibly due to the disrupting effects of FNA on sewer biofilms. This suggests that an initial strong dose (more chemical consumption) followed by maintenance dosing (less chemical consumption) could be a very cost-effective way to achieve consistent control efficiency. It was also found that heavy rainfall slowed the recovery of sulfide production after dosing, likely due to the dilution effects and reduced retention time. Overall, intermittent dose of FNA or FNA in combination with H2O2 was successfully demonstrated to be a cost-effective method for sulfide control in rising main sewers.

  3. Dosing free nitrous acid for sulfide control in sewers: results of field trials in Australia.

    PubMed

    Jiang, Guangming; Keating, Anthony; Corrie, Shaun; O'halloran, Kelly; Nguyen, Lam; Yuan, Zhiguo

    2013-09-01

    Intermittent dosing of free nitrous acid (FNA), with or without the simultaneous dosing of hydrogen peroxide, is a new strategy developed recently for the control of sulfide production in sewers. Six-month field trials have been carried out in a rising main sewer in Australia (150 mm in diameter and 1080 m in length) to evaluate the performance of the strategy that was previously demonstrated in laboratory studies. In each trial, FNA was dosed at a pumping station for a period of 8 or 24 h, some with simultaneous hydrogen peroxide dosing. The sulfide control effectiveness was monitored by measuring, on-line, the dissolved sulfide concentration at a downstream location of the pipeline (828 m from the pumping station) and the gaseous H2S concentration at the discharge manhole. Effective sulfide control was achieved in all nine consecutive trials, with sulfide production reduced by more than 80% in 10 days following each dose. Later trials achieved better control efficiency than the first few trials possibly due to the disrupting effects of FNA on sewer biofilms. This suggests that an initial strong dose (more chemical consumption) followed by maintenance dosing (less chemical consumption) could be a very cost-effective way to achieve consistent control efficiency. It was also found that heavy rainfall slowed the recovery of sulfide production after dosing, likely due to the dilution effects and reduced retention time. Overall, intermittent dose of FNA or FNA in combination with H2O2 was successfully demonstrated to be a cost-effective method for sulfide control in rising main sewers. PMID:23764584

  4. Chemosterilants as control agents of Ceratitis capitata (Diptera: Tephritidae) in field trials.

    PubMed

    Navarro-Llopis, V; Sanchis, J; Primo-Millo, J; Primo-Yúfera, E

    2007-08-01

    Lufenuron is a chitin synthesis inhibitor, which is able to impede Mediterranean fruit fly, Ceratitis capitata (Wiedemann), reproduction. In laboratory trials, following ingestion of lufenuron, the eggs laid by female Ceratitis capitata were prevented from hatching. In field trials in Valencia, Spain, lufenuron showed its effectiveness by reducing C. capitata wild populations and its continuous application to several generations of fruit fly resulted in increased pest control. This field trial was conducted in an isolated valley some 80 ha in size, over a continuous four-year period. In order to maintain the sterilizing effect in the field throughout the whole year, a new lufenuron bait gel was developed. This bait gel was introduced in to delta traps suspended in trees at a density of 24 traps ha-1, and these traps were replaced once a year during the field trial. Monitoring of the adult C. capitata population was conducted to assess the effects of the chemosterilant treatment. In the first year of treatment with sterilizing traps, a reduction of the C. capitata population was observed, indicating that the traps reduce the population right from the first generation. In the second, third and fourth years, a continuous and progressive reduction of the adult Mediterranean fruit fly population was observed. Therefore, the successive application of chemosterilization treatment has a cumulative effect on reducing the fly population year after year. Aerial treatment using malathion does not produce this cumulative effect, and consequently every year it is necessary to start again with the same number of flies as the year before. The possibility of using the chemosterilant method alone or combined with the sterile insect technique is discussed. PMID:17645817

  5. Pulsed electromagnetic fields in knee osteoarthritis: a double blind, placebo-controlled, randomized clinical trial

    PubMed Central

    Miceli, Giovanni; Marino, Natale; Sciortino, Davide; Bagnato, Gian Filippo

    2016-01-01

    Objectives. This trial aimed to test the effectiveness of a wearable pulsed electromagnetic fields (PEMF) device in the management of pain in knee OA patients. Methods. In this randomized [with equal randomization (1:1)], double-blind, placebo-controlled clinical trial, patients with radiographic evidence of knee OA and persistent pain higher than 40 mm on the visual analog scale (VAS) were recruited. The trial consisted of 12 h daily treatment for 1 month in 60 knee OA patients. The primary outcome measure was the reduction in pain intensity, assessed through VAS and WOMAC scores. Secondary outcomes included quality of life assessment through the 36-item Medical Outcomes Study Short-Form version 2 (SF-36 v2), pressure pain threshold (PPT) and changes in intake of NSAIDs/analgesics. Results. Sixty-six patients were included, and 60 completed the study. After 1 month, PEMF induced a significant reduction in VAS pain and WOMAC scores compared with placebo. Additionally, pain tolerance, as expressed by PPT changes, and physical health improved in PEMF-treated patients. A mean treatment effect of −0.73 (95% CI − 1.24 to − 0.19) was seen in VAS score, while the effect size was −0.34 (95% CI − 0.85 to 0.17) for WOMAC score. Twenty-six per cent of patients in the PEMF group stopped NSAID/analgesic therapy. No adverse events were detected. Conclusion. These results suggest that PEMF therapy is effective for pain management in knee OA patients and also affects pain threshold and physical functioning. Future larger studies, including head-to-head studies comparing PEMF therapy with standard pharmacological approaches in OA, are warranted. Trial registration: ClinicalTrials.gov, http://www.clinicaltrials.gov, NCT01877278 PMID:26705327

  6. The Styx field trial

    PubMed Central

    Gemmell, M. A.

    1968-01-01

    An assessment was made of the effectiveness of the generally accepted methods recommended for controlling hydatid disease during the course of a field-trial, initiated in 1943 in an isolated region of New Zealand. The results obtained during the first 21 years are described. Basically, the trial was an attempt to compare the effectiveness of a general public health educational programme and an anthelmintic programme using arecoline hydrobromide for treatment of dogs with that of a specific educational programme using this compound as a diagnostic agent. Arecoline hydrobromide was found to be too uncertain in its action to be of practical value as an anthelmintic. The development of diagnostic techniques, described in this paper, made it possible to use the compound for diagnostic purposes and thus for educational purposes, since each dog could be examined for tapeworms in the presence of the owner. Using changes in the annual prevalence rate in sheep of the cysts of E. granulosus and those of T. hydatigena as the principal indicators, the conclusion has been reached that the specific diagnostic approach achieved more success than the general educational and treatment programme. The principal reason for this appears to be that the former approach induced a greater awareness in owners of the need for strict management to prevent dogs gaining access to infective raw offal than that stimulated in the community when the dogs were dosed but not examined. ImagesFIG. 2FIG. 4FIG. 5 PMID:5303843

  7. Does Encouragement Matter in Improving Gender Imbalances in Technical Fields? Evidence from a Randomized Controlled Trial.

    PubMed

    Unkovic, Cait; Sen, Maya; Quinn, Kevin M

    2016-01-01

    Does encouragement help address gender imbalances in technical fields? We present the results of one of the first and largest randomized controlled trials on the topic. Using an applied statistics conference in the social sciences as our context, we randomly assigned half of a pool of 3,945 graduate students to receive two personalized emails encouraging them to apply (n = 1,976) and the other half to receive nothing (n = 1,969). We find a robust, positive effect associated with this simple intervention and suggestive evidence that women responded more strongly than men. However, we find that women's conference acceptance rates are higher within the control group than in the treated group. This is not the case for men. The reason appears to be that female applicants in the treated group solicited supporting letters at lower rates. Our findings therefore suggest that "low dose" interventions may promote diversity in STEM fields but may also have the potential to expose underlying disparities when used alone or in a non-targeted way.

  8. Does Encouragement Matter in Improving Gender Imbalances in Technical Fields? Evidence from a Randomized Controlled Trial

    PubMed Central

    Unkovic, Cait; Sen, Maya; Quinn, Kevin M.

    2016-01-01

    Does encouragement help address gender imbalances in technical fields? We present the results of one of the first and largest randomized controlled trials on the topic. Using an applied statistics conference in the social sciences as our context, we randomly assigned half of a pool of 3,945 graduate students to receive two personalized emails encouraging them to apply (n = 1,976) and the other half to receive nothing (n = 1,969). We find a robust, positive effect associated with this simple intervention and suggestive evidence that women responded more strongly than men. However, we find that women’s conference acceptance rates are higher within the control group than in the treated group. This is not the case for men. The reason appears to be that female applicants in the treated group solicited supporting letters at lower rates. Our findings therefore suggest that “low dose” interventions may promote diversity in STEM fields but may also have the potential to expose underlying disparities when used alone or in a non-targeted way. PMID:27097315

  9. Does Encouragement Matter in Improving Gender Imbalances in Technical Fields? Evidence from a Randomized Controlled Trial.

    PubMed

    Unkovic, Cait; Sen, Maya; Quinn, Kevin M

    2016-01-01

    Does encouragement help address gender imbalances in technical fields? We present the results of one of the first and largest randomized controlled trials on the topic. Using an applied statistics conference in the social sciences as our context, we randomly assigned half of a pool of 3,945 graduate students to receive two personalized emails encouraging them to apply (n = 1,976) and the other half to receive nothing (n = 1,969). We find a robust, positive effect associated with this simple intervention and suggestive evidence that women responded more strongly than men. However, we find that women's conference acceptance rates are higher within the control group than in the treated group. This is not the case for men. The reason appears to be that female applicants in the treated group solicited supporting letters at lower rates. Our findings therefore suggest that "low dose" interventions may promote diversity in STEM fields but may also have the potential to expose underlying disparities when used alone or in a non-targeted way. PMID:27097315

  10. A Randomized, Controlled Field Trial for the Prevention of Jellyfish Stings With a Topical Sting Inhibitor

    PubMed Central

    Boulware, David R.

    2007-01-01

    Background Jellyfish stings are a common occurrence among ocean goers worldwide with an estimated 150 million envenomations annually. Fatalities and hospitalizations occur annually, particularly in the Indo-Pacific regions. A new topical jellyfish sting inhibitor based on the mucous coating of the clown fish prevents 85% of jellyfish stings in laboratory settings. The field effectiveness is unknown. The objective is to evaluate the field efficacy of the jellyfish sting inhibitor, Safe Sea™. Methods A double-blind, randomized, placebo-controlled trial occurred at the Dry Tortugas National Park, FL, USA and Sapodilla Cayes, Belize. Participants were healthy volunteers planning to snorkel for 30 to 45 minutes. Ten minutes prior to swimming, each participant was directly observed applying a blinded sample of Safe Sea (Nidaria Technology Ltd, Jordan Valley, Israel) to one side of their body and a blinded sample of Coppertone® (Schering-Plough, Kenilworth, NJ, USA) to the contralateral side as placebo control. Masked 26 g samples of both Safe Sea SPF15 and Coppertone® SPF15 were provided in identical containers to achieve 2 mg/cm2 coverage. Sides were randomly chosen by participants. The incidence of jellyfish stings was the main outcome measure. This was assessed by participant interview and examination as subjects exited the water. Results A total of 82 observed water exposures occurred. Thirteen jellyfish stings occurred during the study period for a 16% incidence. Eleven jellyfish stings occurred with placebo, two with the sting inhibitor, resulting in a relative risk reduction of 82% (95% confidence interval: 21%–96%; p = 0.02). No seabather’s eruption or side effects occurred. Conclusions Safe Sea is a topical barrier cream effective at preventing >80% jellyfish stings under real-world conditions. PMID:16706948

  11. Mindfulness Training and Reductions in Teacher Stress and Burnout: Results from Two Randomized, Waitlist-Control Field Trials

    ERIC Educational Resources Information Center

    Roeser, Robert W.; Schonert-Reichl, Kimberly A.; Jha, Amishi; Cullen, Margaret; Wallace, Linda; Wilensky, Rona; Oberle, Eva; Thomson, Kimberly; Taylor, Cynthia; Harrison, Jessica

    2013-01-01

    The effects of randomization to mindfulness training (MT) or to a waitlist-control condition on psychological and physiological indicators of teachers' occupational stress and burnout were examined in 2 field trials. The sample included 113 elementary and secondary school teachers (89% female) from Canada and the United States. Measures were…

  12. Implementing Randomized Controlled Trial Studies in Afterschool Settings: The State of the Field. Afterschool Research Brief. Issue No. 1

    ERIC Educational Resources Information Center

    Vaden-Kiernan, Michael; Jones, Debra Hughes; Rudo, Zena

    2008-01-01

    SEDL is providing analytic and technical support to three large-scale randomized controlled trials assessing the efficacy of promising literacy curriculum in afterschool settings on student academic achievement. In the field of educational research, competition among research organizations and researchers can often impede collaborative efforts in…

  13. Assessment Data-Informed Guidance to Individualize Kindergarten Reading Instruction: Findings from a Cluster-Randomized Control Field Trial

    ERIC Educational Resources Information Center

    Al Otaiba, Stephanie; Connor, Carol M.; Folsom, Jessica S.; Greulich, Luana; Meadows, Jane; Li, Zhi

    2011-01-01

    The purpose of this cluster-randomized control field trial was to examine whether kindergarten teachers could learn to differentiate classroom reading instruction using Individualized Student Instruction for Kindergarten (ISI-K) and to test the efficacy of differentiation on reading outcomes. The study involved 14 schools, 23 ISI-K (n = 305…

  14. Pulsed electromagnetic fields on postmenopausal osteoporosis in Southwest China: a randomized, active-controlled clinical trial.

    PubMed

    Liu, Hui-Fang; Yang, Lin; He, Hong-Chen; Zhou, Jun; Liu, Ying; Wang, Chun-Yan; Wu, Yuan-Chao; He, Cheng-Qi

    2013-05-01

    A randomized, active-controlled clinical trial was conducted to examine the effect of pulsed electromagnetic fields (PEMFs) on women with postmenopausal osteoporosis (PMO) in southwest China. Forty-four participants were randomly assigned to receive alendronate or one course of PEMFs treatment. The primary endpoint was the mean percentage change in bone mineral density of the lumbar spine (BMDL), and secondary endpoints were the mean percentage changes in left proximal femur bone mineral density (BMDF), serum 25OH vitamin D3 (25(OH)D) concentrations, total lower-extremity manual muscle test (LE MMT) score, and Berg Balance Scale (BBS) score. The BMDL, BMDF, total LE MMT score and BBS score were recorded at baseline, 5, 12, and 24 weeks. Serum concentrations of 25(OH)D were measured at baseline and 5 weeks. Using a mixed linear model, there was no significant treatment difference between the two groups in the BMDL, BMDF, total LE MMT score, and BBS score (P ≥ 0.05). For 25(OH)D concentrations, the effects were also comparable between the two groups (P ≥ 0.05) with the Mann-Whitney's U-test. These results suggested that a course of PEMFs treatment with specific parameters was as effective as alendronate in treating PMO within 24 weeks.

  15. Field trials of various molluscicides (chiefly sodium pentachlorophenate) for the control of aquatic intermediate hosts of human bilharziasis *†

    PubMed Central

    Wright, Willard H.; Dobrovolny, Charles G.; Berry, Elmer G.

    1958-01-01

    Field trials of various molluscicides—notably sodium pentachlorophenate, copper sulfate and dinitro-o-cyclohexylphenol—were carried out in Brazil in order to test their effectiveness against the aquatic intermediate hosts of human bilharziasis. Sodium pentachlorophenate was found to be the most effective in relation to cost and availability. Subsequent tests in Egypt, using sodium pentachlorophenate alone, while confirming the effectiveness of this molluscicide in bilharziasis control, have shown that the dosage and methods of application must be adapted to environmental conditions. PMID:13573120

  16. The Styx Field Trial

    PubMed Central

    Gemmell, M. A.

    1978-01-01

    A 13-year assessment has been made of the effectiveness of a monthly drug treatment programme for the control of tapeworms in dogs in order to prevent hydatidosis (Echinococcus granulosus) and cysticercosis (Taenia hydatigena and T. ovis) in sheep. The age-specific prevalence of T. hydatigena in lambs was used as the principal indicator. The trial was carried out in the Styx Valley of the Maniototo Plain in the South Island of New Zealand. Over an 8-year period dogs were treated monthly with bunamidine hydrochloride at about 25 mg/kg with little effect on the prevalence of T. hydatigena in lambs. The addition of niclosamide at 50 mg/kg for 1 year also had little effect. Eggs appeared to survive from one season to the next. Those shed prior to the lamb-rearing season gave rise to endemic-type patterns; whereas patent infections occurring during this period rapidly gave rise to an epidemic-type pattern or a ”cysticercosis storm”. In this 9-year period there were 16 ”cysticercosis storms” and all susceptible lambs were infected. These storms did not necessarily give rise to a similar prevalence on neighbouring farms, but may have contributed to the overall infective pattern. A similar situation occurred in the first year that nitroscanate at 100 mg/kg was introduced. During this 10-year period, arecoline surveillance of the dog population was undertaken in the remainder of the county and many dogs were found to harbour tapeworms. Both resident and introduced dogs may have contributed to the infective patterns in the Styx Valley. Treatment with nitroscanate was continued monthly in the Styx Valley and niclosamide was used in the remainder of the County for a further 3 years. There was a marked reduction in the age-specific prevalence and lambs on many farms were free from T. hydatigena at slaughter. However, one ”breakdown” occurred and this was almost certainly autochthonous. Comparisons with an earlier period when arecoline surveillance was used in the

  17. The use of toxoid for the prevention of tetanus neonatorum. Final report of a double-blind controlled field trial.

    PubMed

    Newell, K W; Dueñas Lehmann, A; LeBlanc, D R; Garces Osorio, N

    1966-01-01

    With a view to determining the effectiveness of a method for the control of tetanus neonatorum which would be independent of medical examination or care, a double-blind field trial covering 1618 women was conducted between 1961 and 1966 in a rural area of Colombia with an estimated existing tetanus neonatorum death rate of 11.6 per 100 births. The study group was given 1-3 injections of 1 ml of an aluminium-phosphate-adsorbed tetanus toxoid more than 6 weeks apart, and the control group a similar number of injections of an influenza-virus vaccine.There was no statistically significant difference between those in the two groups given one injection. Those in the control group given 2 or 3 injections had a tetanus neonatorum death rate of 7.8 deaths per 100 births, and the corresponding subjects in the study group had none. This difference is unlikely to have occurred by chance.

  18. Effects of Gentle Human Touch and Field Massage on Urine Cortisol Level in Premature Infants: A Randomized, Controlled Clinical Trial

    PubMed Central

    Asadollahi, Malihe; Jabraeili, Mahnaz; Mahallei, Majid; Asgari Jafarabadi, Mohammad; Ebrahimi, Sakine

    2016-01-01

    Introduction: Hospitalization in neonatal intensive care unit may leads to many stresses for premature infants. Since premature infants cannot properly process stressors, identifying interventions that reduce the stress level for them is seems necessary. The aim of present study was to compare the effects of Field massage and Gentle Human Touch (GHT) techniques on the urine level of cortisol, as an indicator of stress in preterm infants. Methods: This randomized, controlled clinical trial was carried out in Al-Zahra hospital, Tabriz. A total of 84 premature infants were randomly assigned into three groups. First groups were touched by their mothers three times a day (15 minutes in each session) for 5 days by GHT technique. The second group was received 15 minutes Field massage with sunflower oil three times a day by their mothers for 5 days. The third group received routine care. In all groups, 24-hours urine samples were collected in the first and sixth day after the intervention and analyzed for cortisol level. Data were analyzed by SPSS software. Results: There were significant differences between mean of changes in cortisol level between GHT and control groups and Field massage and control groups (0.026). Conclusion: Although the massage with Field technique resulted in a significant reduction in blood cortisol level, but the GHT technique have also a similar effect. So, both methods are recommended for decreasing of stress in preterm infants. PMID:27752484

  19. Pulsed electromagnetic fields after arthroscopic treatment for osteochondral defects of the talus: double-blind randomized controlled multicenter trial

    PubMed Central

    van Bergen, Christiaan JA; Blankevoort, Leendert; de Haan, Rob J; Sierevelt, Inger N; Meuffels, Duncan E; d'Hooghe, Pieter RN; Krips, Rover; van Damme, Geert; van Dijk, C Niek

    2009-01-01

    Background Osteochondral talar defects usually affect athletic patients. The primary surgical treatment consists of arthroscopic debridement and microfracturing. Although this is mostly successful, early sport resumption is difficult to achieve, and it can take up to one year to obtain clinical improvement. Pulsed electromagnetic fields (PEMFs) may be effective for talar defects after arthroscopic treatment by promoting tissue healing, suppressing inflammation, and relieving pain. We hypothesize that PEMF-treatment compared to sham-treatment after arthroscopy will lead to earlier resumption of sports, and aim at 25% increase in patients that resume sports. Methods/Design A prospective, double-blind, randomized, placebo-controlled trial (RCT) will be conducted in five centers throughout the Netherlands and Belgium. 68 patients will be randomized to either active PEMF-treatment or sham-treatment for 60 days, four hours daily. They will be followed-up for one year. The combined primary outcome measures are (a) the percentage of patients that resume and maintain sports, and (b) the time to resumption of sports, defined by the Ankle Activity Score. Secondary outcome measures include resumption of work, subjective and objective scoring systems (American Orthopaedic Foot and Ankle Society – Ankle-Hindfoot Scale, Foot Ankle Outcome Score, Numeric Rating Scales of pain and satisfaction, EuroQol-5D), and computed tomography. Time to resumption of sports will be analyzed using Kaplan-Meier curves and log-rank tests. Discussion This trial will provide level-1 evidence on the effectiveness of PEMFs in the management of osteochondral ankle lesions after arthroscopy. Trial registration Netherlands Trial Register (NTR1636) PMID:19591674

  20. A field trial in Belgium to control fox rabies by oral immunisation.

    PubMed

    Brochier, B; Thomas, I; Iokem, A; Ginter, A; Kalpers, J; Paquot, A; Costy, F; Pastoret, P P

    1988-12-10

    Campaigns of fox vaccination against rabies were carried out in Belgium in September 1986 and June and September 1987. The SAD B19 attenuated strain of rabies virus was inserted into baits which were distributed over an area of 2100 km2 at a density of 11 baits/km2. As recommended by the World Health Organisation, the efficacy and the innocuity of the method were controlled in the field and in the laboratory. Samples of blood and brain and jaw were taken from foxes which were shot or found dead in the vaccination area, for the diagnosis of rabies, the titration of antirabies antibody and the detection of tetracycline marker. In rabid animals, the virus strain was characterised by immunofluorescence using monoclonal antibodies. In September 1987, the uptake of the baits had reached 72 per cent by 14 days after distribution. Several wild species competed with foxes in taking the baits. After the last campaign, tetracycline was found in 65 per cent of the healthy foxes collected and rabies virus neutralising antibodies were detected in 77 per cent of them. In 1987, the incidence of rabies decreased markedly in the vaccination area compared with the untreated areas. No vaccine virus was isolated either from rabid animals or from 228 small mammals trapped in the vaccination area.

  1. Transcranial pulsed electromagnetic fields for multiple chemical sensitivity: study protocol for a randomized, double-blind, placebo-controlled trial

    PubMed Central

    2013-01-01

    Background Multiple chemical sensitivity (MCS) is a chronic condition of unknown etiology. MCS is characterized by recurrent nonspecific symptoms from multiple organ systems in response to chemical exposures in concentrations that are normally tolerated by the majority of the population. The symptoms may have severe impact on patients’ lives, but an evidence-based treatment for the condition is nonexisting. The pathophysiology is unclarified, but several indicators point towards abnormal processing of sensory signals in the central nervous system. Pulsed electromagnetic fields (PEMF) offer a promising new treatment for refractory depression and can be targeted at the brain, thereby activating biochemical cell processes. Methods/Design In a parallel, randomized, double-blind, placebo-controlled trial conducted at the Danish Research Centre for Chemical Sensitivities, the effects of PEMF in MCS patients will be assessed using the Re5 Independent System. Based on sample size estimation, 40 participants will be randomized to either PEMF therapy or placebo. The allocation sequence will be generated by computer. All involved parties (that is, participants, investigators, the research nurse, and the statistician) will be blinded to group allocation. The participants will receive PEMF therapy or placebo applied transcranially 30 minutes twice a day for 7 days a week over 6 consecutive weeks. Outcomes will be measured at baseline, once weekly during treatment, post treatment, and at 2.5-month and 4.5-month follow-up according to a predefined timetable. The primary outcome will be a measurement of the impact of MCS on everyday life. The secondary outcomes will be measurements of MCS symptoms, psychological distress (stress, anxiety or depressive symptoms), capsaicin-induced secondary punctate hyperalgesia, immunological markers in serum, and quality of life. Discussion This trial will assess the effects of PEMF therapy for MCS. Currently, there is no treatment with a

  2. Cluster Randomized Controlled Trial

    PubMed Central

    Young, John; Chapman, Katie; Nixon, Jane; Patel, Anita; Holloway, Ivana; Mellish, Kirste; Anwar, Shamaila; Breen, Rachel; Knapp, Martin; Murray, Jenni; Farrin, Amanda

    2015-01-01

    Background and Purpose— We developed a new postdischarge system of care comprising a structured assessment covering longer-term problems experienced by patients with stroke and their carers, linked to evidence-based treatment algorithms and reference guides (the longer-term stroke care system of care) to address the poor longer-term recovery experienced by many patients with stroke. Methods— A pragmatic, multicentre, cluster randomized controlled trial of this system of care. Eligible patients referred to community-based Stroke Care Coordinators were randomized to receive the new system of care or usual practice. The primary outcome was improved patient psychological well-being (General Health Questionnaire-12) at 6 months; secondary outcomes included functional outcomes for patients, carer outcomes, and cost-effectiveness. Follow-up was through self-completed postal questionnaires at 6 and 12 months. Results— Thirty-two stroke services were randomized (29 participated); 800 patients (399 control; 401 intervention) and 208 carers (100 control; 108 intervention) were recruited. In intention to treat analysis, the adjusted difference in patient General Health Questionnaire-12 mean scores at 6 months was −0.6 points (95% confidence interval, −1.8 to 0.7; P=0.394) indicating no evidence of statistically significant difference between the groups. Costs of Stroke Care Coordinator inputs, total health and social care costs, and quality-adjusted life year gains at 6 months, 12 months, and over the year were similar between the groups. Conclusions— This robust trial demonstrated no benefit in clinical or cost-effectiveness outcomes associated with the new system of care compared with usual Stroke Care Coordinator practice. Clinical Trial Registration— URL: http://www.controlled-trials.com. Unique identifier: ISRCTN 67932305. PMID:26152298

  3. Solar disinfection of drinking water and diarrhoea in Maasai children: a controlled field trial.

    PubMed

    Conroy, R M; Elmore-Meegan, M; Joyce, T; McGuigan, K G; Barnes, J

    During December 1995-March 1996 in Kajiado Province, Kenya, 206 Maasai children, 5-16 years old, whose drinking water was contaminated with fecal coliform bacteria, were assigned 1.5 liter plastic bottles in which to store their drinking water. These bottles were re-used commercial table water bottles. The families of the children had only community sources for drinking water: 2 open water-holes and 1 tank fed from a piped supply. These water sources were not suited to chlorination. Scarce fuel and indoor air pollution precluded boiling water inside the hut. In the presence of their mothers, 108 children (the solar group) were told to fill the bottles with water at dawn, leave them in full sunlight on the roofs of their homes, and wait until midday before drinking from the bottles. The remaining 98 children (the control group) were told to leave the bottles in their homes. The purpose of the study was to evaluate the effect of solar disinfection on diarrheal disease in these Maasai children. Over a 12-week period, children in the solar group suffered fewer diarrhea episodes than those in the control group (4.1 vs. 4.5; adjusted odds ratio [AOR] = 0.66). They also were less likely to have diarrhea episodes severe enough to prevent them from doing their chores (1.7 vs. 2.3; AOR = 0.65). These findings suggest that solar disinfection of water may reduce diarrhea in communities with no access to other means of disinfection. PMID:8973432

  4. Randomized Controlled Field Trial to Assess the Immunogenicity and Safety of Rift Valley Fever Clone 13 Vaccine in Livestock

    PubMed Central

    Njenga, M. Kariuki; Njagi, Leonard; Thumbi, S. Mwangi; Kahariri, Samuel; Githinji, Jane; Omondi, Eunice; Baden, Amy; Murithi, Mbabu; Paweska, Janusz; Ithondeka, Peter M.; Ngeiywa, Kisa J.; Dungu, Baptiste; Donadeu, Meritxell; Munyua, Peninah M.

    2015-01-01

    Background Although livestock vaccination is effective in preventing Rift Valley fever (RVF) epidemics, there are concerns about safety and effectiveness of the only commercially available RVF Smithburn vaccine. We conducted a randomized controlled field trial to evaluate the immunogenicity and safety of the new RVF Clone 13 vaccine, recently registered in South Africa. Methods In a blinded randomized controlled field trial, 404 animals (85 cattle, 168 sheep, and 151 goats) in three farms in Kenya were divided into three groups. Group A included males and non-pregnant females that were randomized and assigned to two groups; one vaccinated with RVF Clone 13 and the other given placebo. Groups B included animals in 1st half of pregnancy, and group C animals in 2nd half of pregnancy, which were also randomized and either vaccinated and given placebo. Animals were monitored for one year and virus antibodies titers assessed on days 14, 28, 56, 183 and 365. Results In vaccinated goats (N = 72), 72% developed anti-RVF virus IgM antibodies and 97% neutralizing IgG antibodies. In vaccinated sheep (N = 77), 84% developed IgM and 91% neutralizing IgG antibodies. Vaccinated cattle (N = 42) did not develop IgM antibodies but 67% developed neutralizing IgG antibodies. At day 14 post-vaccination, the odds of being seropositive for IgG in the vaccine group was 3.6 (95% CI, 1.5 – 9.2) in cattle, 90.0 (95% CI, 25.1 – 579.2) in goats, and 40.0 (95% CI, 16.5 – 110.5) in sheep. Abortion was observed in one vaccinated goat but histopathologic analysis did not indicate RVF virus infection. There was no evidence of teratogenicity in vaccinated or placebo animals. Conclusions The results suggest RVF Clone 13 vaccine is safe to use and has high (>90%) immunogenicity in sheep and goats but moderate (> 65%) immunogenicity in cattle. PMID:25756501

  5. The Effects of Compensatory Scanning Training on Mobility in Patients with Homonymous Visual Field Defects: A Randomized Controlled Trial

    PubMed Central

    de Haan, Gera A.; Melis-Dankers, Bart J. M.; Brouwer, Wiebo H.; Tucha, Oliver; Heutink, Joost

    2015-01-01

    Introduction Homonymous visual field defects (HVFD) are a common consequence of postchiasmatic acquired brain injury and often lead to mobility-related difficulties. Different types of compensatory scanning training have been developed, aimed at decreasing consequences of the HVFD by changing visual scanning. Aim The aim of the present study is to examine the effects of a compensatory scanning training program using horizontal scanning on mobility-related activities and participation in daily life. Method The main interest of this study is to assess the effectiveness of training on mobility-related activities and participation in daily life. Visual scanning tests, such as dot counting and visual search, and control measures for visual functions and reading have been included as well. First, it is examined how performance on scanning and mobility-related measures is affected in patients with HVFD by comparing scores with scores of a healthy control group (n = 25). Second, the effect of training is assessed using an RCT design, in which performance of 26 patients before and after training is compared to performance of 23 patients in a waiting list control group. Results Self-reported improvements after training were found, accompanied by improvements in detecting peripheral stimuli and avoiding obstacles during walking, especially in dual task situations in which a second task limits the attentional capacity available for compensatory scanning. Training only improved mobility-related activities in which detection of peripheral stimuli is important, while no improvement was found on tests that require other visual skills, such as reading, visual counting and visual search. Conclusion This is the first RCT to evaluate the effects of a compensatory scanning training that is based on a systematic horizontal scanning rhythm. This training improved mobility-related activities. The results suggest that different types of compensatory scanning strategies are appropriate for

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

    PubMed

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

    2001-10-12

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

  7. Long-term field trial to control the invasive Argentine ant (Hymenoptera: Formicidae) with synthetic trail pheromone.

    PubMed

    Nishisue, K; Sunamura, E; Tanaka, Y; Sakamoto, H; Suzuki, S; Fukumoto, T; Terayama, M; Tatsuki, S

    2010-10-01

    Previous short-term experiments showed that trail following behavior of the Argentine ant, Linepithema humile (Mayr) (Hymenoptera: Formicidae), can be disrupted by a high concentration of synthetic trail pheromone component (Z)-9-hexadecenal. In this study, a long-term field trial was conducted in 100-m2 plots of house gardens in an urban area of Japan to see whether the control effect on Argentine ants can be obtained by permeating synthetic trail pheromone from dispensers. The dispensers were placed in the experimental plots during the ant's active season (April-November) for 2 yr with monthly renewal. To estimate Argentine ant population density, foraging activity of Argentine ants in the study plots was monitored by monthly bait surveys. Throughout the study period, Argentine ant foraging activity was suppressed in the presence of the dispensers, presumably via trail forming inhibition. In contrast, the level of foraging activity was not different between treatment and no-treatment plots when the dispensers were temporarily removed, suggesting that treatment with pheromone dispensers did not suppress Argentine ant density in the treatment plots. Population decline may be expected with larger-scale treatment that covers a significant portion of the ant colony or with improvement in the potency of the disruptant. PMID:21061980

  8. 50 CFR 27.91 - Field trials.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 50 Wildlife and Fisheries 8 2011-10-01 2011-10-01 false Field trials. 27.91 Section 27.91 Wildlife... NATIONAL WILDLIFE REFUGE SYSTEM PROHIBITED ACTS Other Disturbing Violations § 27.91 Field trials. The conducting or operation of field trials for dogs on national wildlife refuges is prohibited except as may...

  9. 50 CFR 27.91 - Field trials.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 50 Wildlife and Fisheries 6 2010-10-01 2010-10-01 false Field trials. 27.91 Section 27.91 Wildlife... NATIONAL WILDLIFE REFUGE SYSTEM PROHIBITED ACTS Other Disturbing Violations § 27.91 Field trials. The conducting or operation of field trials for dogs on national wildlife refuges is prohibited except as may...

  10. Assessment Data-Informed Guidance to Individualize Kindergarten Reading Instruction: Findings from a Cluster-Randomized Control Field Trial.

    PubMed

    Al Otaiba, Stephanie; Connor, Carol M; Folsom, Jessica Sidler; Greulich, Luana; Meadows, Jane; Li, Zhi

    2011-06-01

    The purpose of this cluster-randomized control field trial was to was to examine the extent to which kindergarten teachers could learn a promising instructional strategy, wherein kindergarten reading instruction was differentiated based upon students' ongoing assessments of language and literacy skills and documented child characteristic by instruction (CXI) interactions; and to test the efficacy of this differentiated reading instruction on the reading outcomes of students from culturally diverse backgrounds. The study involved 14 schools and included 23 treatment (n = 305 students) and 21 contrast teacher (n = 251 students). Teachers in the contrast condition received only a baseline professional development that included a researcher-delivered summer day-long workshop on individualized instruction. Data sources included parent surveys, individually administered child assessments of language, cognitive, and reading skills and videotapes of classroom instruction. Using Hierarchical Multivariate Linear Modeling (HMLM), we found students in treatment classrooms outperformed students in the contrast classrooms on a latent measure of reading skills, comprised of letter-word reading, decoding, alphabetic knowledge, and phonological awareness (ES = .52). Teachers in both conditions provided small group instruction, but teachers in the treatment condition provided significantly more individualized instruction. Our findings extend research on the efficacy of teachers using Individualized Student Instruction to individualize instruction based upon students' language and literacy skills in first through third grade. Findings are discussed regarding the value of professional development related to differentiating core reading instruction and the challenges of using Response to Intervention approaches to address students' needs in the areas of reading in general education contexts.

  11. A cluster randomized control field trial of the ABRACADABRA web-based reading technology: replication and extension of basic findings.

    PubMed

    Piquette, Noella A; Savage, Robert S; Abrami, Philip C

    2014-01-01

    The present paper reports a cluster randomized control trial evaluation of teaching using ABRACADABRA (ABRA), an evidence-based and web-based literacy intervention (http://abralite.concordia.ca) with 107 kindergarten and 96 grade 1 children in 24 classes (12 intervention 12 control classes) from all 12 elementary schools in one school district in Canada. Children in the intervention condition received 10-12 h of whole class instruction using ABRA between pre- and post-test. Hierarchical linear modeling of post-test results showed significant gains in letter-sound knowledge for intervention classrooms over control classrooms. In addition, medium effect sizes were evident for three of five outcome measures favoring the intervention: letter-sound knowledge (d= +0.66), phonological blending (d = +0.52), and word reading (d = +0.52), over effect sizes for regular teaching. It is concluded that regular teaching with ABRA technology adds significantly to literacy in the early elementary years.

  12. A controlled field trial of the effectiveness of acetone-dried and inactivated and heat-phenol-inactivated typhoid vaccines in Yugoslavia*

    PubMed Central

    1964-01-01

    In 1954-60 a Yugoslav Typhoid Commission showed in the first controlled field trial of typhoid vaccines, carried out in Osijek, Yugoslavia, that heat-phenol-inactivated typhoid vaccine gave a relatively high and long-lasting immunity. However, this liquid vaccine preparation was unstable and laboratory potency tests were inconclusive, and it was therefore decided that stable, dried, heat-killed, phenol-preserved vaccine be tested together with an acetone-inactivated and -dried vaccine in controlled field trials, supported in part by the World Health Organization, in Yugoslavia and British Guiana. This is report on the controlled trials organized in two Yugoslav towns, Bitola and Priština. Three comparable groups were formed by random allocation of vaccines among 45 497 volunteers in the two towns. In each town one group received heat-phenol vaccine, the second group acetone-dried vaccine and the third (control) group tetanus toxoid. Two doses were given four weeks apart in the spring of 1960 and the vaccinated persons were followed up for 2 1/2 years. The effectiveness of the vaccines was measured by comparing typhoid morbidity rates in the three groups. It was found during an outbreak of typhoid fever in Priština two years after primary vaccination that both the acetone-dried and the heat-phenol vaccines were effective, the former being superior. PMID:14196811

  13. Practical experience in deploying and controlling the data sharing interoperability layer at the U.K. Land Open Systems Architecture (LOSA) field trials in October 2012

    NASA Astrophysics Data System (ADS)

    Bergamaschi, Flavio; Conway-Jones, Dave; Pearson, Gavin

    2013-05-01

    In October 2012 the UK MoD sponsored a multi-vendor field integration trial in support of its Land Open Systems Architecture (LOSA), an open, service based architecture for systems integration and interoperability which builds on the progress made with the Generic Vehicle Architecture (GVA, DefStan 23-09), Generic Base Architecture (GBA, DefStan 23-13) and the Generic Soldier Architecture (DefStan 23-12) programs. The aim of this trial was to experiment with a common data and power interoperability across and in support of the Soldier, Vehicles and Bases domains. This paper presents an overview of the field trial and discusses how the ITA Information Fabric, technology originated in the US and UK International Technology Alliance program, was extended to support the control of the data interoperability layer across various data bearers. This included: (a) interoperability and information sharing across multiple stove piped and legacy solutions; (b) command and control and bandwidth optimization of streamed data (e.g. video) over a peer-to-peer ad-hoc network across multiple domains- integration of disparate sensor systems; (c) integration with DDS based C2 systems.

  14. Birth Control in Clinical Trials

    PubMed Central

    Stewart, J.; Beyer, B. K.; Chadwick, K.; De Schaepdrijver, L.; Desai, M.; Enright, B.; Foster, W.; Hui, J. Y.; Moffat, G. J.; Tornesi, B.; Van Malderen, K.; Wiesner, L.; Chen, C. L.

    2015-01-01

    The Health and Environmental Sciences Institute (HESI) Developmental and Reproductive Toxicology Technical Committee sponsored a pharmaceutical industry survey on current industry practices for contraception use during clinical trials. The objectives of the survey were to improve our understanding of the current industry practices for contraception requirements in clinical trials, the governance processes set up to promote consistency and/or compliance with contraception requirements, and the effectiveness of current contraception practices in preventing pregnancies during clinical trials. Opportunities for improvements in current practices were also considered. The survey results from 12 pharmaceutical companies identified significant variability among companies with regard to contraception practices and governance during clinical trials. This variability was due primarily to differences in definitions, areas of scientific uncertainty or misunderstanding, and differences in company approaches to enrollment in clinical trials. The survey also revealed that few companies collected data in a manner that would allow a retrospective understanding of the reasons for failure of birth control during clinical trials. In this article, suggestions are made for topics where regulatory guidance or scientific publications could facilitate best practice. These include provisions for a pragmatic definition of women of childbearing potential, guidance on how animal data can influence the requirements for male and female birth control, evidence-based guidance on birth control and pregnancy testing regimes suitable for low- and high-risk situations, plus practical methods to ascertain the risk of drug-drug interactions with hormonal contraceptives. PMID:27042398

  15. 50 CFR 27.91 - Field trials.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 50 Wildlife and Fisheries 9 2013-10-01 2013-10-01 false Field trials. 27.91 Section 27.91 Wildlife and Fisheries UNITED STATES FISH AND WILDLIFE SERVICE, DEPARTMENT OF THE INTERIOR (CONTINUED) THE... conducting or operation of field trials for dogs on national wildlife refuges is prohibited except as may...

  16. 7 CFR 1755.3 - Field trials.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... service degradation or hazards to life or property. (g) Field trials shall be conducted in accordance with...) Trunk carriers; (iii) Subscriber carrier; (iv) Point-to-point radio (Microwave); (v) Coaxial...

  17. 7 CFR 1755.3 - Field trials.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... service degradation or hazards to life or property. (g) Field trials shall be conducted in accordance with...) Trunk carriers; (iii) Subscriber carrier; (iv) Point-to-point radio (Microwave); (v) Coaxial...

  18. 7 CFR 1755.3 - Field trials.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... service degradation or hazards to life or property. (g) Field trials shall be conducted in accordance with...) Trunk carriers; (iii) Subscriber carrier; (iv) Point-to-point radio (Microwave); (v) Coaxial...

  19. Practical Issues when Planning for Field Trials

    NASA Astrophysics Data System (ADS)

    Andersson, Susanne; Andersson, Anna-Lena

    This chapter is written from a test site leader perspective and describes the role of planning and timing of field trials when testing technical solutions, which could enable people with dementia to live a more independent life. The chapter is based on experiences from setting up the first and second field trials in the three test sites of the COGKNOW project. The intention is to point out some key issues that are important in preparation and planning of a field trial. The chapter addresses issues in the preparatory, the actual and the post-test phase of the field trial in order to help achieve a high level of success both from a general perspective and with a special focus on people with dementia.

  20. Student Participation in Rover Field Trials

    NASA Astrophysics Data System (ADS)

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

    2001-12-01

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

  1. Effects of pulsed electromagnetic fields on peripheral blood circulation in people with diabetes: A randomized controlled trial.

    PubMed

    Sun, Jiahui; Kwan, Rachel Lai-Chu; Zheng, Yongping; Cheing, Gladys Lai-Ying

    2016-07-01

    Cutaneous blood flow provides nourishment that plays an essential role in maintaining skin health. We examined the effects of pulsed electromagnetic fields (PEMFs) on cutaneous circulation of dorsal feet. Twenty-two patients with diabetes mellitus (DM) and 21 healthy control subjects were randomly allocated to receive either PEMFs or sham PEMFs (0.5 mT, 12 Hz, 30 min). Blood flow velocity and diameter of the small vein were examined by using ultrasound biomicroscopy; also, microcirculation at skin over the base of the 1st metatarsal bone (Flux1) and distal 1st phalange (Flux2) was measured by laser Doppler flowmetry before and after intervention. Results indicated that PEMFs produced significantly greater changes in blood flow velocity of the smallest observable vein than did sham PEMFs (both P < 0.05) in both types of subjects. However, no significant difference was found in changes of vein diameter, nor in Flux1 and Flux2, between PEMFs and sham PEMFs groups in subjects with or without DM. We hypothesized that PEMFs would increase blood flow velocity of the smallest observable vein in people with or without DM. Bioelectromagnetics. 37:290-297, 2016. © 2016 Wiley Periodicals, Inc.

  2. Canadian MSAT field trial program user requirements

    NASA Technical Reports Server (NTRS)

    Pedersen, Allister

    1990-01-01

    A wide range of mobile satellite service offerings will be available in late 1993 with the launch of Canada's first satellite devoted almost exclusively to mobile and transportable services. During the last seven years, the Dept. of Communications has been meeting with potential MSAT users in government and the private sector as part of a $20M Communications Trials Program. User trials will be conducted using leased capacity as well as capacity on Canada's MSAT satellite. User requirements are discussed which were identified under the Communications Trials Program. Land, marine, aeronautical, and fixed applications are described from the perspective of the end users. Emphasis is placed on field trials being accomplished using leased capacity such as the marine data trial being implemented by Ultimateast Data Communications, trials using transportable briefcase terminals and additional field trials being considered for implementation with the TMI Mobile Data Service. The pre-MSAT trials that will be conducted using leased capacity are only a limited sample of the overall end user requirements that have been identified to date. Additional end user applications are discussed, along with a summary of user benefits.

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

    NASA Technical Reports Server (NTRS)

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

    2002-01-01

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

  4. 7 CFR 1755.3 - Field trials.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... TELECOMMUNICATIONS POLICIES ON SPECIFICATIONS, ACCEPTABLE MATERIALS, AND STANDARD CONTRACT FORMS § 1755.3 Field..., the borrower possesses: (1) Adequate financial resources so that no delay in the project will result... Telecommunications Equipment Field Trial (available from the Director, Administrative Services Division,...

  5. Field Assessment of a Novel Household-Based Water Filtration Device: A Randomised, Placebo-Controlled Trial in the Democratic Republic of Congo

    PubMed Central

    Boisson, Sophie; Kiyombo, Mbela; Sthreshley, Larry; Tumba, Saturnin; Makambo, Jacques; Clasen, Thomas

    2010-01-01

    Background Household water treatment can improve the microbiological quality of drinking water and may prevent diarrheal diseases. However, current methods of treating water at home have certain shortcomings, and there is evidence of bias in the reported health impact of the intervention in open trial designs. Methods and Findings We undertook a randomised, double-blinded, placebo-controlled trial among 240 households (1,144 persons) in rural Democratic Republic of Congo to assess the field performance, use and effectiveness of a novel filtration device in preventing diarrhea. Households were followed up monthly for 12 months. Filters and placebos were monitored for longevity and for microbiological performance by comparing thermotolerant coliform (TTC) levels in influent and effluent water samples. Mean longitudinal prevalence of diarrhea was estimated among participants of all ages. Compliance was assessed through self-reported use and presence of water in the top vessel of the device at the time of visit. Over the 12-month follow-up period, data were collected for 11,236 person-weeks of observation (81.8% total possible). After adjusting for clustering within the household, the longitudinal prevalence ratio of diarrhoea was 0.85 (95% confidence interval: 0.61–1.20). The filters achieved a 2.98 log reduction in TTC levels while, for reasons that are unclear, the placebos achieved a 1.05 log reduction (p<0.0001). After 8 months, 68% of intervention households met the study's definition of current users, though most (73% of adults and 95% of children) also reported drinking untreated water the previous day. The filter maintained a constant flow rate over time, though 12.4% of filters were damaged during the course of the study. Conclusions While the filter was effective in improving water quality, our results provide little evidence that it was protective against diarrhea. The moderate reduction observed nevertheless supports the need for larger studies that

  6. The impact of an urban sewerage system on childhood diarrhoea in Tehran, Iran: a concurrent control field trial.

    PubMed

    Kolahi, Ali-Asghar; Rastegarpour, Ali; Sohrabi, Mohammad-Reza

    2009-05-01

    The stepwise implementation of the Tehran Sewerage Project provided a convenient setting for which health impacts of an urban sewerage system could be examined with appropriate controls. In 2001, Tehran municipal districts 17 and 18 had no sewerage system connections, but areas within these districts had been planned to be connected by 2006. These areas were chosen as an intervention group. Neighbouring areas, with a similar socio-economic status, that had not been planned to connect to the sewerage system by 2006, were chosen as controls. Homes within designated areas were randomized and surveyed twice to determine diarrhoea incidences for children aged 6-60 months, once in 2001, before connection to the sewerage system, and once again in 2006, after the intervention. By 2006, 76% of the homes in the intervention zones were connected to the sewerage system. In the first stage of the study, diarrhoea incidences for intervention and control groups were 18.6 and 16.6%, respectively. In the second stage, incidences decreased to 10.1 and 10.5%, respectively. Data collected from 4179 children demonstrated that the diarrhoea incidence had decreased by 46% in the intervention group, whereas it had decreased by 37% in the controls.

  7. 7 CFR 1755.3 - Field trials.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ..., the borrower possesses: (1) Adequate financial resources so that no delay in the project will result from lack of funds. (2) The financial stability to overcome difficulties which may result from an... meets its financial obligations with respect to the field trial. (3) Qualified personnel to enable it...

  8. Evaluation of the insect growth regulator Lufenuron (Match®) for control of Aedes aegypti by simulated field trials.

    PubMed

    Salokhe, S G; Deshpande, S G; Mukherjee, S N

    2012-09-01

    The insect growth regulator, Lufenuron, at concentrations of even multiples of LC(90) (determined under laboratory conditions) was tested against the III instar larvae of Aedes aegypti under simulated field conditions. For all concentrations tested, 100 % mortality of the larvae was observed within 24 h of exposure to Lufenuron-treated water. In experiments with LC(90) × 4 Lufenuron concentration and where 15 % of water volume was replaced daily, percent mortality of the larvae was reduced to 40 % after the 54th day of treatment. Percentage mortality of the III instar larvae on the 54th day was higher in water with LC(90) × 6 concentration than that observed for water with LC(90) × 4 of Lufenuron. In the experiments with LC(90) × 4 and LC(90) × 6 concentrations of Lufenuron where 15 % of water volume was replaced weekly, larval mortality obtained after the eighth week was 68.75 and 88.33 %, respectively. In LC(90) × 4 and LC(90) × 6 of Lufenuron-treated stagnant water (without replacement of water), the percent mortality of the larvae on the 55th day was 65 and 90 %, respectively. Introducing a fresh batch of III instar A. aegypti larvae in the Lufenuron-treated waters revealed that residual activity of Lufenuron was sustained for 45 days after the treatment. All these experiments revealed that Lufenuron not only affects the prevalence of the A. aegypti larvae but also induces the development of abnormal adults. PMID:22638920

  9. Challenges of randomized controlled trial design in plastic surgery.

    PubMed

    Hassanein, Aladdin H; Herrera, Fernando A; Hassanein, Omar

    2011-01-01

    Randomized controlled trials are the gold standard of evidence-based medicine. In the field of plastic surgery, designing these studies is much more challenging than in pharmaceutical medicine. Randomized trials in plastic surgery encompass several road blocks including problems shared with other surgical trials: equipoise, high cost, placebo issues and learning curves following the establishment of a novel approach. In addition, plastic surgery has more subjective outcomes, thus making study design even more difficult in assessing the end result.

  10. Large-scale field trials of active immunizing agents

    PubMed Central

    Cockburn, W. Charles

    1955-01-01

    In this discussion of the methods to be used in large-scale field trials of active immunizing agents and of the results to be expected from such trials, special emphasis is laid on pertussis vaccine trials in Great Britain. After a review of the criteria for strictly controlled field studies and of the investigation of typhoid vaccines conducted in 1904-08 by the Antityphoid Committee of the British Army, the author describes the pertussis vaccine studies which have been and are now being carried by the Whooping-Cough Immunization Committee of the Medical Research Council of Great Britain. The original strictly controlled trials have been completed and the results published. Studies are now being made of vaccines prepared by different methods and evaluated both in the field and in the laboratory. Each vaccine is given to some 2000-3000 children of 4-6 months to 4 years of age. By the end of the studies 30 000-40 000 children will have been followed up for a period of two years. Since in the current studies all the children are vaccinated and none are left as unvaccinated controls, the relative and not the absolute protective value of the vaccines will be measured. PMID:13270079

  11. Biochar: from laboratory mechanisms through the greenhouse to field trials

    NASA Astrophysics Data System (ADS)

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

    2014-12-01

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

  12. Placebo-Controlled Trials in Surgery

    PubMed Central

    Probst, Pascal; Grummich, Kathrin; Harnoss, Julian C.; Hüttner, Felix J.; Jensen, Katrin; Braun, Silvia; Kieser, Meinhard; Ulrich, Alexis; Büchler, Markus W.; Diener, Markus K.

    2016-01-01

    Abstract This systematic review was performed to investigate the ethical justification, methodological quality, validity and safety of placebo controls in randomized placebo-controlled surgical trials. Central, MEDLINE, and EMBASE were systematically searched to identify randomized controlled trials comparing a surgical procedure to a placebo. “Surgical procedure” was defined as a medical procedure involving an incision with instruments. Placebo was defined as a blinded sham operation involving no change to the structural anatomy and without an expectable physiological response in the target body compartment. Ten randomized placebo-controlled controlled surgical trials were included, all of them published in high-ranking medical journals (mean impact factor: 20.1). Eight of 10 failed to show statistical superiority of the experimental intervention. Serious adverse events did not differ between the groups (rate ratio [RR] 1.38, 95% confidence interval [CI]: 0.92–2.06, P = 0.46). None of the trials had a high risk of bias in any domain. The ethical justification for the use of a placebo control remained unclear in 2 trials. Placebo-controlled surgical trials are feasible and provide high-quality data on efficacy of surgical treatments. The surgical placebo entails a considerable risk for study participants. Consequently, a placebo should be used only if justified by the clinical question and by methodological necessity. Based on the current evidence, a pragmatic proposal for the use of placebo controls in future randomized controlled surgical trials is made. PMID:27124060

  13. Field trials results of guided wave tomography

    SciTech Connect

    Volker, Arno Zon, Tim van; Leden, Edwin van der

    2015-03-31

    Corrosion is one of the industries major issues regarding the integrity of assets. Guided wave travel time tomography is a method capable of providing an absolute wall thickness map. This method is currently making the transition from the laboratory to the field. For this purpose a dedicated data acquisition system and special purpose EMAT sensor rings have been developed. The system can be deployed for permanent monitoring and inspections. Field trials have been conducted on various pipes with different diameters, containing either liquid or gas. The main focus has been on pipe supports. The results demonstrate the successful operation of the technology in the field. Expected corrosion damage was clearly visible on the produced results enabling asset owner to make calculated decisions on the pipelines safety, maintenance and operations.

  14. Field trials results of guided wave tomography

    NASA Astrophysics Data System (ADS)

    Volker, Arno; van Zon, Tim; van der Leden, Edwin

    2015-03-01

    Corrosion is one of the industries major issues regarding the integrity of assets. Guided wave travel time tomography is a method capable of providing an absolute wall thickness map. This method is currently making the transition from the laboratory to the field. For this purpose a dedicated data acquisition system and special purpose EMAT sensor rings have been developed. The system can be deployed for permanent monitoring and inspections. Field trials have been conducted on various pipes with different diameters, containing either liquid or gas. The main focus has been on pipe supports. The results demonstrate the successful operation of the technology in the field. Expected corrosion damage was clearly visible on the produced results enabling asset owner to make calculated decisions on the pipelines safety, maintenance and operations.

  15. Quality control in bacteriology: preliminary trials

    PubMed Central

    Stokes, E. Joan; Whitby, J. L.

    1971-01-01

    Six trials of quality control material sent in the form of artificial specimens are reported. A method of assessment using a computer for complex results, including antibiotic sensitivity tests, was employed. The trials were successful in showing the need for a comprehensive service and in bringing to light by this method a wide variety of errors. Images PMID:4946416

  16. The Efficacy and Safety of Knotless Barbed Sutures in the Surgical Field: A Systematic Review and Meta-analysis of Randomized Controlled Trials

    PubMed Central

    Lin, Yifei; Lai, Sike; Huang, Jin; Du, Liang

    2016-01-01

    The knotless barbed suture is an innovative type of suture that can accelerate the placement of sutures and eliminate knot tying. However, the outcomes of previous studies are still confounding. This study reviewed the application of different types of barbed sutures in different surgeries. We searched PubMed, EMBASE, CENTRAL and ClinicalTrials.gov to identify randomized controlled trials (RCTs) addressing the application of barbed sutures up to Feb. 2015. Two reviewers independently screened the literature and assessed the risk of bias of included studies. Then meta-analysis was performed using RevMan 5.3 software. Sensitivity analysis and subgroup analysis was performed. Seventeen RCTs (low to moderate risk of bias) involving 1992 patients were included. Compared with conventional sutures, the barbed suture could reduce suture time (SMD=−0.95, 95%CI −1.43 to −0.46, P = 0.0001) and the operative time (SMD=−0.28, 95%CI −0.46 to −0.10, P = 0.003), not significantly increase the estimated blood loss (SMD=−0.09, 95%CI −0.52 to 0.35, P = 0.70), but could lead to more postoperative complications (OR = 1.43, 95%CI 1.05 to 1.96, P = 0.03), These results varied in subgroups. Thus, barbed sutures are effective in reducing the suture and operative time, but the safety evidences are still not sufficient. It need be evaluated based on special surgeries and suture types before put into clinical practice. PMID:27005688

  17. Preliminary field trials of acrolein in the Sudan*

    PubMed Central

    Ferguson, Frederick F.; Dawood, Ismail K.; Blondeau, René

    1965-01-01

    Field trials of acrolein for the simultaneous control of aquatic weeds and snails were conducted in the Sudan. Phytotoxicity studies at 25 and 50 ppm showed minor or no damage to furrow-irrigated crops, but flood irrigation of vegetable seedlings at 15 ppm was toxic. Effective downstream carriage of acrolein was demonstrated for a distance of 1.6 km at a concentration of 25 ppm. Planorbid snails (Bulinus and Biomphalaria) were almost completely eliminated (98-99% kills). All submersed aquatic weeds were destroyed. PMID:14310912

  18. Reporting Randomized Controlled Trials in Education

    ERIC Educational Resources Information Center

    Mayo-Wilson, Evan; Grant, Sean; Montgomery, Paul

    2014-01-01

    Randomized controlled trials (RCTs) are increasingly used to evaluate programs and interventions in order to inform education policy and practice. High quality reports of these RCTs are needed for interested readers to understand the rigor of the study, the interventions tested, and the context in which the evaluation took place (Mayo-Wilson et…

  19. Recruiting Participants for Randomized Controlled Trials

    ERIC Educational Resources Information Center

    Gallagher, H. Alix; Roschelle, Jeremy; Feng, Mingyu

    2014-01-01

    The objective of this study was to look across strategies used in a wide range of studies to build a framework for researchers to use in conceptualizing the recruitment process. This paper harvests lessons learned across 19 randomized controlled trials in K-12 school settings conducted by a leading research organization to identify strategies that…

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

    PubMed Central

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

    1977-01-01

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

  1. High compliance randomized controlled field trial of solar disinfection of drinking water and its impact on childhood diarrhea in rural Cambodia.

    PubMed

    McGuigan, Kevin G; Samaiyar, Priyajit; du Preez, Martella; Conroy, Ronán M

    2011-09-15

    Recent solar disinfection (SODIS) studies in Bolivia and South Africa have reported compliance rates below 35% resulting in no overall statistically significant benefit associated with disease rates. In this study, we report the results of a 1 year randomized controlled trial investigating the effect of SODIS of drinking water on the incidence of dysentery and nondysentery diarrhea among children of age 6 months to 5 years living in rural communities in Cambodia. We compared 426 children in 375 households using SODIS with 502 children in 407 households with no intervention. Study compliance was greater than 90% with only 5% of children having less than 10 months of follow-up and 2.3% having less than 6 months. Adjusted for water source type, children in the SODIS group had a reduced incidence of dysentery, with an incidence rate ratio (IRR) of 0.50 (95% CI 0.27-0.93, p = 0.029). SODIS also had a protective effect against nondysentery diarrhea, with an IRR of 0.37 (95% CI 0.29-0.48, p < 0.001). This study suggests strongly that SODIS is an effective and culturally acceptable point-of-use water treatment method in the culture of rural Cambodia and may be of benefit among similar communities in neighboring South East Asian countries.

  2. Field Trials With 0.5% Novaluron Insecticide Applied as a Bait to Control Subterranean Termites (Reticulitermes sp. and Coptotermes formosanus [Isoptera: Rhinotermitidae]) on Structures.

    PubMed

    Keefer, T C; Puckett, Robert T; Brown, Ken S; Gold, Roger E

    2015-10-01

    A field study was initiated in 2009 with 0.5% novaluron the BASF Advance Termite Bait System, which was 100% effective in controlling Reticulitermes sp. Holmgren and Coptotermes formosanus Shiraki infestations on 11 structures in the Texas City, TX area. Stations with inspection cartridges (cellulose tablets) and monitoring bases (southern yellow pine) and independent monitoring devices were installed in an alternating pattern around each structure and were inspected every 30 d postinstallation. When subterranean termite activity was confirmed on the inspection cartridge or the monitoring base, the inspection cartridge was removed and replaced with a bait cartridge containing 0.5% novaluron insecticide on a proprietary matrix (124 g/cartridge) in a station. Once the novaluron-treated bait was inserted, inspections of that station were made on a 4-mo cycle until no termite activity was observed. The mean time to achieve control of the subterranean termites on the structures was 10.5 mo post initial installation of bait. Mean time to achieve control of the termites on the structures after the baits were installed was 5.4 mo. Control of the termites on the structures required consumption of a mean of 1.3 bait cartridges (166.2 g) of 0.5% novaluron bait matrix per structure. These results indicate that the baits with 0.5% novaluron were effective in controlling termites on the structures used in this study.

  3. RANDOMIZED CONTROLLED CLINICAL TRIALS IN ORTHOPEDICS: DIFFICULTIES AND LIMITATIONS

    PubMed Central

    Malavolta, Eduardo Angeli; Demange, Marco Kawamura; Gobbi, Riccardo Gomes; Imamura, Marta; Fregni, Felipe

    2015-01-01

    Randomized controlled clinical trials (RCTs) are considered to be the gold standard for evidence-based medicine nowadays, and are important for directing medical practice through consistent scientific observations. Steps such as patient selection, randomization and blinding are fundamental for conducting a RCT, but some additional difficulties are presented in trials that involve surgical procedures, as is common in orthopedics. The aim of this article was to highlight and discuss some difficulties and possible limitations on RCTs within the field of surgery. PMID:27027037

  4. Conducting field trials for frost tolerance breeding in cereals.

    PubMed

    Cattivelli, Luigi

    2014-01-01

    Cereal species can be damaged by frost either during winter or at flowering stage. Frost tolerance per se is only a part of the mechanisms that allow the plants to survive during winter; winterhardiness also considers other biotic or physical stresses that challenge the plants during the winter season limiting their survival rate. While frost tolerance can also be tested in controlled environments, winterhardiness can be determined only with field evaluations. Post-heading frost damage occurs from radiation frost events in spring during the reproductive stages. A reliable evaluation of winterhardiness or of post-heading frost damage should be carried out with field trials replicated across years and locations to overcome the irregular occurrence of natural conditions which satisfactorily differentiate genotypes. The evaluation of post-heading frost damage requires a specific attention to plant phenology. The extent of frost damage is usually determined with a visual score at the end of the winter.

  5. The first documented controlled trial in history.

    PubMed

    Koren, Gideon

    2015-01-01

     The first reported controlled human trial was conducted 2500 years ago by the Biblical judge Gideon Ben Yoash, who challenged God's Angel: "I will put a fleece of wool on the threshing floor. If there is dew on the fleece only, and it is dry on all the ground, then I will know that Thou wilt deliver Israel through me, as Thou hast spoken". In the control part of the trial he asked the Angel to keep the wool dry while the ground around it will be soaked with morning dew. It is unfortunate that these principles were not practiced for thousands of years thereafter, as many medical challenges could have been solved earlier.  

  6. Meta-analyses of randomized controlled trials.

    PubMed

    Sacks, H S; Berrier, J; Reitman, D; Ancona-Berk, V A; Chalmers, T C

    1987-02-19

    A new type of research, termed meta-analysis, attempts to analyze and combine the results of previous reports. We found 86 meta-analyses of reports of randomized controlled trials in the English-language literature. We evaluated the quality of these meta-analyses, using a scoring method that considered 23 items in six major areas--study design, combinability, control of bias, statistical analysis, sensitivity analysis, and application of results. Only 24 meta-analyses (28 percent) addressed all six areas, 31 (36 percent) addressed five, 25 (29 percent) addressed four, 5 (6 percent) addressed three, and 1 (1 percent) addressed two. Of the 23 individual items, between 1 and 14 were addressed satisfactorily (mean +/- SD, 7.7 +/- 2.7). We conclude that an urgent need exists for improved methods in literature searching, quality evaluation of trials, and synthesizing of the results.

  7. Field trials in Egypt with acrolein herbicide-molluscicide*

    PubMed Central

    Unrau, G. O.; Farooq, M.; Dawood, Ismail K.; Miguel, Luis C.; Dazo, B. C.

    1965-01-01

    Acrolein is a dual-purpose chemical effective against both submersed weeds and snails, and it may therefore be of significance in bilharziasis control. During trials in the Egypt-49-project area in 1962, it was effective in clearing heavy mats of the major submersed aquatic weed Potamogeton crispus from irrigation canals. The resurgence of snails to pretreatment levels was delayed by 8-12 months, and submersed weeds did not reappear until 8 months after treatment. In phytotoxicity tests on local crops, it was found that the concentration of acrolein required for destroying submersed weeds (20-25 ppm) had no adverse effect on the crops. The field tests showed that it is important to have complete control of the water during the period of application. PMID:14310913

  8. Girdling defoliation of cotton; 2014 field trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Cotton mechanical harvest requires field pre-treatment to remove leaves and moisture. Typical harvest preparation involves ground or aerial application of a combination of active ingredients. Some of these chemicals may come under regulatory pressure in future. Alternatives have been explored, su...

  9. Multi-optical mine detection: results from a field trial

    NASA Astrophysics Data System (ADS)

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

    2006-05-01

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

  10. Randomized Control Trial of Composite Cuspal Restorations

    PubMed Central

    Fennis, W.M.; Kuijs, R.H.; Roeters, F.J.; Creugers, N.H.; Kreulen, C.M.

    2014-01-01

    The objective of this randomized control trial was to compare the five-year clinical performance of direct and indirect resin composite restorations replacing cusps. In 157 patients, 176 restorations were made to restore maxillary premolars with Class II cavities and one missing cusp. Ninety-two direct and 84 indirect resin composite restorations were placed by two operators, following a strict protocol. Treatment technique and operator were assigned randomly. Follow-up period was at least 4.5 yrs. Survival rates were determined with time to reparable failure and complete failure as endpoints. Kaplan-Meier five-year survival rates were 86.6% (SE 0.27%) for reparable failure and 87.2% (SE 0.27%) for complete failure. Differences between survival rates of direct and indirect restorations [89.9% (SE 0.34%) vs. 83.2% (SE 0.42%) for reparable failure and 91.2% (SE 0.32%) vs. 83.2% (SE 0.42%) for complete failure] were not statistically significant (p = .23 for reparable failure; p = .15 for complete failure). Mode of failure was predominantly adhesive. The results suggest that direct and indirect techniques provide comparable results over the long term (trial registration number: ISRCTN29200848). PMID:24155264

  11. Randomised controlled trial of mesalazine in IBS

    PubMed Central

    Barbara, Giovanni; Cremon, Cesare; Annese, Vito; Basilisco, Guido; Bazzoli, Franco; Bellini, Massimo; Benedetti, Antonio; Benini, Luigi; Bossa, Fabrizio; Buldrini, Paola; Cicala, Michele; Cuomo, Rosario; Germanà, Bastianello; Molteni, Paola; Neri, Matteo; Rodi, Marcello; Saggioro, Alfredo; Scribano, Maria Lia; Vecchi, Maurizio; Zoli, Giorgio; Corinaldesi, Roberto; Stanghellini, Vincenzo

    2016-01-01

    Objective Low-grade intestinal inflammation plays a role in the pathophysiology of IBS. In this trial, we aimed at evaluating the efficacy and safety of mesalazine in patients with IBS. Design We conducted a phase 3, multicentre, tertiary setting, randomised, double-blind, placebo-controlled trial in patients with Rome III confirmed IBS. Patients were randomly assigned to either mesalazine, 800 mg, or placebo, three times daily for 12 weeks, and were followed for additional 12 weeks. The primary efficacy endpoint was satisfactory relief of abdominal pain/discomfort for at least half of the weeks of the treatment period. The key secondary endpoint was satisfactory relief of overall IBS symptoms. Supportive analyses were also performed classifying as responders patients with a percentage of affirmative answers of at least 75% or >75% of time. Results A total of 185 patients with IBS were enrolled from 21 centres. For the primary endpoint, the responder patients were 68.6% in the mesalazine group versus 67.4% in the placebo group (p=0.870; 95% CI −12.8 to 15.1). In explorative analyses, with the 75% rule or >75% rule, the percentage of responders was greater in the mesalazine group with a difference over placebo of 11.6% (p=0.115; 95% CI −2.7% to 26.0%) and 5.9% (p=0.404; 95% CI −7.8% to 19.4%), respectively, although these differences were not significant. For the key secondary endpoint, overall symptoms improved in the mesalazine group and reached a significant difference of 15.1% versus placebo (p=0.032; 95% CI 1.5% to 28.7%) with the >75% rule. Conclusions Mesalazine treatment was not superior than placebo on the study primary endpoint. However, a subgroup of patients with IBS showed a sustained therapy response and benefits from a mesalazine therapy. Trial registration number ClincialTrials.gov number, NCT00626288. PMID:25533646

  12. Empirical trials of plant field guides.

    PubMed

    Hawthorne, W D; Cable, S; Marshall, C A M

    2014-06-01

    We designed 3 image-based field guides to tropical forest plant species in Ghana, Grenada, and Cameroon and tested them with 1095 local residents and 20 botanists in the United Kingdom. We compared users' identification accuracy with different image formats, including drawings, specimen photos, living plant photos, and paintings. We compared users' accuracy with the guides to their accuracy with only their prior knowledge of the flora. We asked respondents to score each format for usability, beauty, and how much they would pay for it. Prior knowledge of plant names was generally low (<22%). With a few exceptions, identification accuracy did not differ significantly among image formats. In Cameroon, users identifying sterile Cola species achieved 46-56% accuracy across formats; identification was most accurate with living plant photos. Botanists in the United Kingdom accurately identified 82-93% of the same Cameroonian species; identification was most accurate with specimens. In Grenada, users accurately identified 74-82% of plants; drawings yielded significantly less accurate identifications than paintings and photos of living plants. In Ghana, users accurately identified 85% of plants. Digital color photos of living plants ranked high for beauty, usability, and what users would pay. Black and white drawings ranked low. Our results show the potential and limitations of the use of field guides and nonspecialists to identify plants, for example, in conservation applications. We recommend authors of plant field guides use the cheapest or easiest illustration format because image type had limited bearing on accuracy; match the type of illustration to the most likely use of the guide for slight improvements in accuracy; avoid black and white formats unless the audience is experienced at interpreting illustrations or keeping costs low is imperative; discourage false-positive identifications, which were common; and encourage users to ask an expert or use a herbarium for

  13. Empirical trials of plant field guides.

    PubMed

    Hawthorne, W D; Cable, S; Marshall, C A M

    2014-06-01

    We designed 3 image-based field guides to tropical forest plant species in Ghana, Grenada, and Cameroon and tested them with 1095 local residents and 20 botanists in the United Kingdom. We compared users' identification accuracy with different image formats, including drawings, specimen photos, living plant photos, and paintings. We compared users' accuracy with the guides to their accuracy with only their prior knowledge of the flora. We asked respondents to score each format for usability, beauty, and how much they would pay for it. Prior knowledge of plant names was generally low (<22%). With a few exceptions, identification accuracy did not differ significantly among image formats. In Cameroon, users identifying sterile Cola species achieved 46-56% accuracy across formats; identification was most accurate with living plant photos. Botanists in the United Kingdom accurately identified 82-93% of the same Cameroonian species; identification was most accurate with specimens. In Grenada, users accurately identified 74-82% of plants; drawings yielded significantly less accurate identifications than paintings and photos of living plants. In Ghana, users accurately identified 85% of plants. Digital color photos of living plants ranked high for beauty, usability, and what users would pay. Black and white drawings ranked low. Our results show the potential and limitations of the use of field guides and nonspecialists to identify plants, for example, in conservation applications. We recommend authors of plant field guides use the cheapest or easiest illustration format because image type had limited bearing on accuracy; match the type of illustration to the most likely use of the guide for slight improvements in accuracy; avoid black and white formats unless the audience is experienced at interpreting illustrations or keeping costs low is imperative; discourage false-positive identifications, which were common; and encourage users to ask an expert or use a herbarium for

  14. Dengue surveillance in preparation for field vaccine trials.

    PubMed

    Letson, G William

    2009-10-01

    Preparations for dengue vaccine trials as well as vaccine introduction strategies require laboratory-based surveillance on an international and coordinated level. The Pediatric Dengue Vaccine Initiative (PDVI) has developed an international consortium of field sites in Latin America and Asia. These sites conduct community- based and enhanced passive laboratory-based surveillance of dengue fever. Through this consortium, PDVI is facilitating harmonized laboratory-based surveillance processes, so that disease incidence can be compared between different regions and countries. This process prepares sites for the rigorous case detection, diagnosis, recording and analysis to meet good clinical practice standards necessary for clinical dengue vaccine trials. In addition to several years of laboratory-based dengue surveillance data, dengue vaccine trial site criteria include low population migration of an endemic disease area, documentation of other local flavivirus epidemiology, good medical infrastructure, political stability, and country and target population commitment to vaccine trials and need for vaccine. Prevention of dengue fever is the most suitable primary end point for a proof-of-concept dengue vaccine trial. However, such trials may provide insufficient information for stratified analysis of outcomes according to varied risk factors and virus serotype. Consequently large community-based demonstration trials may be necessary.

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

    PubMed

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

    2008-12-01

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

  16. BIOLOGICAL CONTROL OF WHEAT TAKE-ALL DISEASE: II – RAPID SELECTION OF BACTERIA SUPPRESSIVE TO GAEUMANNOMYCES GRAMINIS VAR. TRITICI IN LABORATORY WITH GREENHOUSE AND FIELD CONFIRMATION TRIALS

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Screening large collections of bacteria for potential biological control activity on economically important diseases is often difficult. A quick test tube assay was developed to rapidly screen selected bacterial isolates for their ability to suppress take-all disease of wheat, caused by Gaeumannomyc...

  17. ADULTS: A RANDOMIZED CONTROLLED CLINICAL TRIAL

    PubMed Central

    Shah, Krupa N.; Majeed, Zahraa; Yoruk, Yilmaz B.; Yang, Hongmei; Hilton, Tiffany N.; McMahon, James M.; Hall, William J.; Walck, Donna; Luque, Amneris E.; Ryan, Richard M.

    2016-01-01

    Objective HIV-infected older adults (HOA) are at risk of functional decline. Interventions promoting physical activity that can attenuate functional decline and are easily translated into the HOA community are of high priority. We conducted a randomized, controlled clinical trial to evaluate whether a physical activity counseling intervention based on self-determination theory (SDT) improves physical function, autonomous motivation, depression and the quality of life (QOL) in HOA. Methods A total of 67 community-dwelling HOA with mild-to-moderate functional limitations were randomized to one of two groups: a physical activity counseling group or the usual care control group. We used SDT to guide the development of the experimental intervention. Outcome measures that were collected at baseline and final study visits included a battery of physical function tests, levels of physical activity, autonomous motivation, depression, and QOL. Results The study participants were similar in their demographic and clinical characteristics in both the treatment and control groups. Overall physical performance, gait speed, measures of endurance and strength, and levels of physical activity improved in the treatment group compared to the control group (p<0.05). Measures of autonomous regulation such as identified regulation, and measures of depression and QOL improved significantly in the treatment group compared to the control group (p<0.05). Across the groups, improvement in intrinsic regulation and QOL correlated with an improvement in physical function (p<0.05). Conclusion Our findings suggest that a physical activity counseling program grounded in SDT can improve physical function, autonomous motivation, depression, and QOL in HOA with functional limitations. PMID:26867045

  18. A Multisite Cluster Randomized Field Trial of Open Court Reading

    ERIC Educational Resources Information Center

    Borman, Geoffrey D.; Dowling, N. Maritza; Schneck, Carrie

    2008-01-01

    In this article, the authors report achievement outcomes of a multisite cluster randomized field trial of Open Court Reading 2005 (OCR), a K-6 literacy curriculum published by SRA/McGraw-Hill. The participants are 49 first-grade through fifth-grade classrooms from predominantly minority and poor contexts across the nation. Blocking by grade level…

  19. Differences in Field Effectiveness and Adoption between a Novel Automated Chlorination System and Household Manual Chlorination of Drinking Water in Dhaka, Bangladesh: A Randomized Controlled Trial

    PubMed Central

    Pickering, Amy J.; Crider, Yoshika; Amin, Nuhu; Bauza, Valerie; Unicomb, Leanne; Davis, Jennifer; Luby, Stephen P.

    2015-01-01

    The number of people served by networked systems that supply intermittent and contaminated drinking water is increasing. In these settings, centralized water treatment is ineffective, while household-level water treatment technologies have not been brought to scale. This study compares a novel low-cost technology designed to passively (automatically) dispense chlorine at shared handpumps with a household-level intervention providing water disinfection tablets (Aquatab), safe water storage containers, and behavior promotion. Twenty compounds were enrolled in Dhaka, Bangladesh, and randomly assigned to one of three groups: passive chlorinator, Aquatabs, or control. Over a 10-month intervention period, the mean percentage of households whose stored drinking water had detectable total chlorine was 75% in compounds with access to the passive chlorinator, 72% in compounds receiving Aquatabs, and 6% in control compounds. Both interventions also significantly improved microbial water quality. Aquatabs usage fell by 50% after behavioral promotion visits concluded, suggesting intensive promotion is necessary for sustained uptake. The study findings suggest high potential for an automated decentralized water treatment system to increase consistent access to clean water in low-income urban communities. PMID:25734448

  20. Differences in field effectiveness and adoption between a novel automated chlorination system and household manual chlorination of drinking water in Dhaka, Bangladesh: a randomized controlled trial.

    PubMed

    Pickering, Amy J; Crider, Yoshika; Amin, Nuhu; Bauza, Valerie; Unicomb, Leanne; Davis, Jennifer; Luby, Stephen P

    2015-01-01

    The number of people served by networked systems that supply intermittent and contaminated drinking water is increasing. In these settings, centralized water treatment is ineffective, while household-level water treatment technologies have not been brought to scale. This study compares a novel low-cost technology designed to passively (automatically) dispense chlorine at shared handpumps with a household-level intervention providing water disinfection tablets (Aquatab), safe water storage containers, and behavior promotion. Twenty compounds were enrolled in Dhaka, Bangladesh, and randomly assigned to one of three groups: passive chlorinator, Aquatabs, or control. Over a 10-month intervention period, the mean percentage of households whose stored drinking water had detectable total chlorine was 75% in compounds with access to the passive chlorinator, 72% in compounds receiving Aquatabs, and 6% in control compounds. Both interventions also significantly improved microbial water quality. Aquatabs usage fell by 50% after behavioral promotion visits concluded, suggesting intensive promotion is necessary for sustained uptake. The study findings suggest high potential for an automated decentralized water treatment system to increase consistent access to clean water in low-income urban communities.

  1. Systematic Motorcycle Management and Health Care Delivery: A Field Trial

    PubMed Central

    Rerolle, Francois; Rammohan, Sonali V.; Albohm, Davis C.; Muwowo, George; Moseson, Heidi; Sept, Lesley; Lee, Hau L.; Bendavid, Eran

    2016-01-01

    Objectives. We investigated whether managed transportation improves outreach-based health service delivery to rural village populations. Methods. We examined systematic transportation management in a small-cluster interrupted time series field trial. In 8 districts in Southern Zambia, we followed health workers at 116 health facilities from September 2011 to March 2014. The primary outcome was the average number of outreach trips per health worker per week. Secondary outcomes were health worker productivity, motorcycle performance, and geographical coverage. Results. Systematic fleet management resulted in an increase of 0.9 (SD = 1.0) trips to rural villages per health worker per week (P < .001), village-level health worker productivity by 20.5 (SD = 5.9) patient visits, 10.2 (SD = 1.5) measles immunizations, and 5.2 (SD = 5.4) child growth assessments per health worker per week. Motorcycle uptime increased by 3.5 days per week (P < .001), use by 1.5 days per week (P < .001), and mean distance by 9.3 kilometers per trip (P < .001). Geographical coverage of health outreach increased in experimental (P < .001) but not control districts. Conclusions. Systematic motorcycle management improves basic health care delivery to rural villages in resource-poor environments through increased health worker productivity and greater geographical coverage. PMID:26562131

  2. Pediatric Nephrologists’ Beliefs Regarding Randomized Controlled Trials

    PubMed Central

    Wightman, Aaron G; Oron, Assaf P; Symons, Jordan M; Flynn, Joseph T

    2014-01-01

    Background Pediatrics and pediatric nephrology lag behind adult medicine in producing randomized controlled trials (RCTs). Physician attitudes have been shown to play a significant role in RCT enrollment. Methods We surveyed members of the American Society of Pediatric Nephrology regarding beliefs about RCTs and factors influencing decisions to recommend RCT enrollment. Regression analyses were used to identify effects of variables on an aggregate score summarizing attitudes toward RCTs. Results 130 replies were received. 66% had enrolled patients in RCTs. Respondents in practice >15 years were more likely to have recruited a patient to a RCT than those in practice <5 years. Respondents were more willing to recommend RCT enrollment if the study was multicenter, patients were sicker or had a poorer prognosis, or if the parent or participant received a financial incentive versus the provider. In multiple regression analysis, history of enrolling patients in a RCT was the only significant predictor of higher aggregate RCT-friendly attitude. Conclusions Many pediatric nephrologists have never enrolled a patient in a RCT, particularly those in practice <5 years. Respondents who have not enrolled patients in RCTs have a less RCT-friendly attitude. Provision of improved training and resources might increase participation of junior providers in RCTs. PMID:24379023

  3. Teaching Children to Cross Streets Safely: A Randomized Controlled Trial

    PubMed Central

    Schwebel, David C.; McClure, Leslie A.; Severson, Joan

    2014-01-01

    Objective Child pedestrian injury is a global public health challenge. This randomized controlled trial considered comparative efficacy of individualized streetside training, training in a virtual pedestrian environment, training using videos and websites, plus no-training control, to improve children’s street-crossing ability. Methods Pedestrian safety was evaluated among 231 seven- and eight-year-olds using both streetside (field) and laboratory-based (virtual environment) trials prior to intervention group assignment, immediately post-training, and six months post-training. All training groups received six 30-minute sessions. Four outcomes assessed pedestrian safety: start delay (temporal lag before initiating crossing), hits/close calls (collisions/near-misses with vehicles in simulated crossings), attention to traffic (looks left and right, controlled for time), and missed opportunities (safe crossing opportunities that were missed). Results Results showed training in the virtual pedestrian environment and especially individualized streetside training resulted in safer pedestrian behavior post-intervention and at follow-up. As examples, children trained streetside entered safe traffic gaps more quickly post-training than control group children and children trained streetside or in the virtual environment had somewhat fewer hits/close calls in post-intervention VR trials. Children showed minimal change in attention to traffic post-training. Children trained with videos/websites showed minimal learning. Conclusion Both individualized streetside training and training within virtual pedestrian environments may improve 7- and 8-year-olds’ street-crossing safety. Individualized training has limitations of adult time and labor. Virtual environment training has limitations of accessibility and cost. Given the public health burden of child pedestrian injuries, future research should explore innovative strategies for effective training that can be broadly

  4. Telemedicine and Cooperative Remote Healthcare Services: COPD Field Trial.

    PubMed

    Gerdes, Martin; Smaradottir, Berglind; Reichert, Frank; Fensli, Rune

    2015-01-01

    The introduction of sustainable telemedicine solutions throughout Europe requires the development of secure, flexible and expandable systems and the evaluation of their operation in real-world settings such as field trials. This paper describes a system for a remote monitoring and care support field trial with Chronic Obstructive Pulmonary Disease (COPD) patients. By following a user-centred-development and Privacy by Design approach, the needs of all involved user groups could be addressed, while fulfilling, at the same time, national requirements with emphasis in security and privacy protection. The solution covers specific applications and services for COPD patients and their remote care takers, but allows the generalization of its applicability to other patient groups.

  5. Design and Management of Field Trials of Transgenic Cereals

    NASA Astrophysics Data System (ADS)

    Bedő, Zoltán; Rakszegi, Mariann; Láng, László

    The development of gene transformation systems has allowed the introgression of alien genes into plant genomes, thus providing a mechanism for broadening the genetic resources available to plant breeders. The design and the management of field trials vary according to the purpose for which transgenic cereals are developed. Breeders study the phenotypic and genotypic stability of transgenic plants, monitor the increase in homozygosity of transgenic genotypes under field conditions, and develop backcross generations to transfer the introduced genes into secondary transgenic cereal genotypes. For practical purposes, they may also multiply seed of the transgenic lines to produce sufficient amounts of grain for the detailed analysis of trait(s) of interest, to determine the field performance of transgenic lines, and to compare them with the non-transformed parental genotypes. Prior to variety registration, the Distinctness, Uniformity and Stability (DUS) tests and Value for Cultivation and Use (VCU) experiments are carried out in field trials. Field testing includes specific requirements for transgenic cereals to assess potential environmental risks. The capacity of the pollen to survive, establish and disseminate in the field test environment, the potential for gene transfer, the effects of products expressed by the introduced sequences and phenotypic and genotypic instability that might cause deleterious effects must all be specifically monitored, as required by EU Directives 2003/701/EC (1) on the release of genetically modified higher plants in the environment.

  6. Determination of the immunization schedule for field trials with the synthetic malaria vaccine SPf 66.

    PubMed

    Rocha, C L; Murillo, L A; Mora, A L; Rojas, M; Franco, L; Cote, J; Valero, M V; Moreno, A; Amador, R; Nuñez, F

    1992-01-01

    The synthetic malaria vaccine SPf 66 has been shown to be safe, immunogenic and effective in trials performed with controlled groups naturally and experimentally exposed to the disease. In order to continue the trials in open populations, it was necessary to standardize the vaccination characteristics. We have performed four field trials with soldier volunteers with the aim, among others, of defining the number of doses required, the intervals between applications, the protein concentration, and the adjuvant to be used. In these trials, the vaccinated individuals' immune responses were evaluated by assaying anti-SPf 66 antibody titres, in vitro growth inhibition of the P. falciparum parasite, and the vaccinees' capacity to recognize P. falciparum native proteins. From these results we conclude that the best vaccination schedule, for adults, is three doses administered subcutaneously on days 0, 30 and 180, each containing 2 mg of the synthetic polymerized petide SPf 66 adsorbed to alum hydroxide.

  7. Clinical Research Methodology 3: Randomized Controlled Trials.

    PubMed

    Sessler, Daniel I; Imrey, Peter B

    2015-10-01

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

  8. Beyond the Randomized Controlled Trial: A Review of Alternatives in mHealth Clinical Trial Methods

    PubMed Central

    Wiljer, David; Cafazzo, Joseph A

    2016-01-01

    Background Randomized controlled trials (RCTs) have long been considered the primary research study design capable of eliciting causal relationships between health interventions and consequent outcomes. However, with a prolonged duration from recruitment to publication, high-cost trial implementation, and a rigid trial protocol, RCTs are perceived as an impractical evaluation methodology for most mHealth apps. Objective Given the recent development of alternative evaluation methodologies and tools to automate mHealth research, we sought to determine the breadth of these methods and the extent that they were being used in clinical trials. Methods We conducted a review of the ClinicalTrials.gov registry to identify and examine current clinical trials involving mHealth apps and retrieved relevant trials registered between November 2014 and November 2015. Results Of the 137 trials identified, 71 were found to meet inclusion criteria. The majority used a randomized controlled trial design (80%, 57/71). Study designs included 36 two-group pretest-posttest control group comparisons (51%, 36/71), 16 posttest-only control group comparisons (23%, 16/71), 7 one-group pretest-posttest designs (10%, 7/71), 2 one-shot case study designs (3%, 2/71), and 2 static-group comparisons (3%, 2/71). A total of 17 trials included a qualitative component to their methodology (24%, 17/71). Complete trial data collection required 20 months on average to complete (mean 21, SD 12). For trials with a total duration of 2 years or more (31%, 22/71), the average time from recruitment to complete data collection (mean 35 months, SD 10) was 2 years longer than the average time required to collect primary data (mean 11, SD 8). Trials had a moderate sample size of 112 participants. Two trials were conducted online (3%, 2/71) and 7 trials collected data continuously (10%, 7/68). Onsite study implementation was heavily favored (97%, 69/71). Trials with four data collection points had a longer study

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

    USGS Publications Warehouse

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

    2001-01-01

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

  10. Efficacy of the "Responsive Classroom" Approach: Results from a 3-Year, Longitudinal Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Rimm-Kaufman, Sara E.; Larsen, Ross A. A.; Baroody, Alison E.; Curby, Timothy W.; Ko, Michelle; Thomas, Julia B.; Merritt, Eileen G.; Abry, Tashia; DeCoster, Jamie

    2014-01-01

    This randomized controlled field trial examined the efficacy of the Responsive Classroom (RC) approach on student achievement. Schools (n = 24) were randomized into intervention and control conditions; 2,904 children were studied from end of second to fifth grade. Students at schools assigned to the RC condition did not outperform students at…

  11. A sequential procedure for monitoring clinical trials against historical controls.

    PubMed

    Xiong, Xiaoping; Tan, Ming; Boyett, James

    2007-03-30

    In this paper, we develop a sequential procedure to monitor clinical trials against historical controls. When there is a strong ethical concern about randomizing patients to existing treatment because biological and medical evidence suggests that the new treatment is potentially superior to the existing one, or when the enrollment is too limited for randomization of subjects into experimental and control groups, one can monitor the trial sequentially against historical controls if the historical data with required quality and sample size are available to form a valid reference for the trial. This design of trial is sometimes the only alternative to a randomized phase III trial design that is intended but not feasible in situations such as above. Monitoring this type of clinical trial leads to a statistical problem of comparing two population means in a situation in which data from one population are sequentially collected and compared with all data from the other population at each interim look. The proposed sequential procedures is based on the sequential conditional probability ratio test (SCPRT) by which the conclusion of the sequential test would be virtually the same as that arrived at by a non-sequential test based on all data at the planned end of the trial. We develop the sequential procedure by proposing a Brownian motion that emulates the test statistic, and then proposing an SCPRT that is adapted to the special properties of the trial. PMID:16900551

  12. Trial-by-Trial Adaptation of Movements during Mental Practice under Force Field

    PubMed Central

    Anwar, Muhammad Nabeel

    2013-01-01

    Human nervous system tries to minimize the effect of any external perturbing force by bringing modifications in the internal model. These modifications affect the subsequent motor commands generated by the nervous system. Adaptive compensation along with the appropriate modifications of internal model helps in reducing human movement errors. In the current study, we studied how motor imagery influences trial-to-trial learning in a robot-based adaptation task. Two groups of subjects performed reaching movements with or without motor imagery in a velocity-dependent force field. The results show that reaching movements performed with motor imagery have relatively a more focused generalization pattern and a higher learning rate in training direction. PMID:23737857

  13. A sensitivity analysis for subverting randomization in controlled trials.

    PubMed

    Marcus, S M

    2001-02-28

    In some randomized controlled trials, subjects with a better prognosis may be diverted into the treatment group. This subverting of randomization results in an unobserved non-compliance with the originally intended treatment assignment. Consequently, the estimate of treatment effect from these trials may be biased. This paper clarifies the determinants of the magnitude of the bias and gives a sensitivity analysis that associates the amount that randomization is subverted and the resulting bias in treatment effect estimation. The methods are illustrated with a randomized controlled trial that evaluates the efficacy of a culturally sensitive AIDS education video.

  14. Field trial of five repellent formulations against mosquitoes in Ahero, Kenya.

    PubMed

    Sherwood, Van; Kioko, Elizabeth; Kasili, Sichangi; Ngumbi, Philip; Hollingdale, Michael R

    2009-01-01

    Twelve volunteers, using one leg for repellent application and the other leg as a control, field-tested 5 insect repellent formulations--Avon's (New York, NY) SS220 Spray, SS220 Lotion, and Bayrepel Lotion, and SC Johnson's (Racine, Wisconsin) Autan Bayrepel Lotion--against the standard N,N-diethyl-3-methyl-benzamide (deet) in a rice-growing district near Kisumu, western Kenya, in 2 trials in May and June 2004. In addition to a control leg for each volunteer, an additional control was introduced into the study by the use of a sixth repellent, a "null repellent," which was literally a treatment application of no repellent at all. The 5 active repellent formulations were uniformly applied at the maximum Environmental Protection Agency recommended dose of 1.5 g per 600 cm2 in the first trial and half that dose in the second trial, and none of them failed during the nightly 12-hour test period over 6 consecutive days, May 19 through May 24, 2004, and June 14 through June 19, 2004. However, the repellent control legs demonstrated a statistically significant increased landing rate compared to both the null repellent and the null repellent control leg. This suggests that, in this approach, active repellents increased the capture rate on an adjacent control leg compared to null controls. A single human volunteer can act as his/her own control provided null treatment controls are included.

  15. From Controlled Trial to Community Adoption: The Multisite Translational Community Trial

    PubMed Central

    Murimi, Mary; Gonzalez, Anjelica; Njike, Valentine; Green, Lawrence W.

    2011-01-01

    Methods for translating the findings of controlled trials, such as the Diabetes Prevention Program, into real-world community application have not been clearly defined. A standardized research methodology for making and evaluating such a transition is needed. We introduce the multisite translational community trial (mTCT) as the research analog to the multisite randomized controlled trial. The mTCT is adapted to incorporate the principles and practices of community-based participatory research and the increased relevance and generalizability gained from diverse community settings. The mTCT is a tool designed to bridge the gap between what a clinical trial demonstrates can work in principle and what is needed to make it workable and effective in real-world settings. Its utility could be put to the test, in particular with practice-based research networks such as the Prevention Research Centers. PMID:21680935

  16. Field trial of a Doppler sonar system for fisheries applications

    NASA Astrophysics Data System (ADS)

    Tollefsen, Cristina D. S.; Zedel, Len

    2003-10-01

    Various deployments of commercial Doppler current profiling systems have demonstrated that these instruments can detect fish and measure their swimming speeds. However, research into the possible application of Doppler sonar to fisheries problems is limited and has not taken advantage of coherent signal processing schemes. A field trial was undertaken in August 2002 to explore the capabilities of a coherent Doppler sonar when applied to detecting discrete targets. The passage of migrating salmon on the Fraser River in British Columbia provided an ideal test opportunity with fish of well-defined swimming behavior and allowed for comparisons with conventional fisheries acoustics techniques. The instrument tested was a 250-kHz sonar which provided for phase coding of transmit pulses and coherent sampling of successive acoustic returns. The field trial resulted in 11 consecutive days of Doppler sonar data acquired during the peak of the sockeye salmon (Oncorhynchus nerka) migration. A total of 7425 individual fish were identified and their swimming speed was measured with an accuracy of between 10 cms-1 and 20 cms-1, which depended on pulse length, pulse spacing, and target range. By comparison, water velocity measurements made with the same instrument can only achieve a theoretical accuracy of 60 cms-1.

  17. 2010 Uniform biological control trials - preliminary results

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Because substantially reducing Fusarium head blight (FHB) of wheat has proven to be difficult using any one control measure, integrated control approaches are seen as the best opportunity to consistently reduce the disease. Biological control agents (BCAs), applied as a tank mix with fungicides at ...

  18. Results of 2009 uniform biological control Trials

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Due to the difficulty of substantially reducing Fusarium head blight of wheat with any one control measure, integrated control approaches are seen as the best opportunity to consistently reduce the disease. Biological control agents (BCA’s), applied as a part of a tank mix with fungicides at flower...

  19. Perceptions of Massage Therapists Participating in a Randomized Controlled Trial

    PubMed Central

    Perlman, Adam; Dreusicke, Mark; Keever, Teresa; Ali, Ather

    2015-01-01

    Background Clinical practice and randomized trials often have disparate aims, despite involving similar interventions. Attitudes and expectancies of practitioners influence patient outcomes, and there is growing emphasis on optimizing provider–patient relationships. In this study, we evaluated the experiences of licensed massage therapists involved in a randomized controlled clinical trial using qualitative methodology. Methods Seven massage therapists who were interventionists in a randomized controlled trial participated in structured interviews approximately 30 minutes in length. Interviews focused on their experiences and perceptions regarding aspects of the clinical trial, as well as recommendations for future trials. Transcribed interviews were analyzed for emergent topics and themes using standard qualitative methods. Results Six themes emerged. Therapists discussed 1) promoting the profession of massage therapy through research, 2) mixed views on using standardized protocols, 3) challenges of sham interventions, 4) participant response to the sham intervention, 5) views on scheduling and compensation, and 6) unanticipated benefits of participating in research. Conclusions Therapists largely appreciated the opportunity to promote massage through research. They demonstrated insight and understanding of the rationale for a clinical trial adhering to a standardized protocol. Evaluating the experiences and ideas of complementary and alternative medicine practitioners provides valuable insight that is relevant for the implementation and design of randomized trials. PMID:26388961

  20. Discrepancies between registration and publication of randomised controlled trials: an observational study

    PubMed Central

    Stevenson, Graham; Thornton, James G

    2014-01-01

    Summary Objectives To determine the consistency between information contained in the registration and publication of randomised controlled trials (RCTs). Design An observational study of RCTs published between May 2011 and May 2012 in the British Medical Journal (BMJ) and the Journal of the American Medical Association (JAMA) comparing registry data with publication data. Participants and Settings Data extracted from published RCTs in BMJ and JAMA. Main outcome measures Timing of trial registration in relation to completion of trial data collection and publication. Registered versus published primary and secondary outcomes, sample size. Results We identified 40 RCTs in BMJ and 36 in JAMA. All 36 JAMA trials and 39 (98%) BMJ trials were registered. All registered trials were registered prior to publication. Thirty-two (82%) BMJ trials recorded the date of data completion; of these, in two trials the date of trial registration postdated the registered date of data completion. There were discrepancies between primary outcomes declared in the trial registry information and in the published paper in 18 (47%) BMJ papers and seven (19%) JAMA papers. The original sample size stated in the trial registration was achieved in 24 (60%) BMJ papers and 21 (58%) JAMA papers. Conclusions Compulsory registration of RCTs is meaningless if the content of registry information is not complete or if discrepancies between registration and publication are not reported. This study demonstrates that discrepancies in primary and secondary outcomes and sample size between trial registration and publication remain commonplace, giving further strength to the World Health Organisation’s argument for mandatory completion of a minimum number of compulsory fields. PMID:25057391

  1. Composting in cold climates: Results from two field trials

    SciTech Connect

    McMillen, S.J.; Kerr, J.M.; Davis, P.S.; Bruney, J.M.

    1996-12-31

    Two composting field trials have been successfully completed at Exxon Company USA`s Big Stick Madison Unit (BSMU) in Billings, North Dakota and Imperial Oil`s (Exxon`s Canadian affiliate) Willesden Green producing field in the Province of Alberta, Canada. Composting is a bioremediation method in which bulking agents such as manure, wood chips, and straw are added to oily soil/sludge to improve the soil texture, tilth, air permeability, water holding capacity, and organic matter content. The compost mixture is placed in windrows or static piles where heat is generated by microbial breakdown of hydrocarbons and organic matter. Because composting conserves heat generated by biodegradation, it is well suited for bioremediating wastes in cold climates. In addition, the temperature in the piles increases the rate of the biochemical processes responsible for oil degradation and can significantly reduce the time required to achieve a remediation target. Elevated temperatures were observed in both field trials, and in Canada the compost piles remained warm throughout the winter months thereby expanding the normal bioremediation season. Hydrocarbon loss data indicate that clean-up criteria for both sites was met within a few months. Extensive hydrocarbon characterization confirmed that the total petroleum hydrocarbon losses were due to biodegradation. At the BSMU site 71 cubic yards (54 m{sup 3}) of oily soil were composted in five windrows that were aerated by periodic tilling, and at Willesden Green 1700 cubic yards (1300 m{sup 3}) of oily soil were composted in three static, passively aerated piles.

  2. Field Balancing of Magnetically Levitated Rotors without Trial Weights

    PubMed Central

    Fang, Jiancheng; Wang, Yingguang; Han, Bangcheng; Zheng, Shiqiang

    2013-01-01

    Unbalance in magnetically levitated rotor (MLR) can cause undesirable synchronous vibrations and lead to the saturation of the magnetic actuator. Dynamic balancing is an important way to solve these problems. However, the traditional balancing methods, using rotor displacement to estimate a rotor's unbalance, requiring several trial-runs, are neither precise nor efficient. This paper presents a new balancing method for an MLR without trial weights. In this method, the rotor is forced to rotate around its geometric axis. The coil currents of magnetic bearing, rather than rotor displacement, are employed to calculate the correction masses. This method provides two benefits when the MLR's rotation axis coincides with the geometric axis: one is that unbalanced centrifugal force/torque equals the synchronous magnetic force/torque, and the other is that the magnetic force is proportional to the control current. These make calculation of the correction masses by measuring coil current with only a single start-up precise. An unbalance compensation control (UCC) method, using a general band-pass filter (GPF) to make the MLR spin around its geometric axis is also discussed. Experimental results show that the novel balancing method can remove more than 92.7% of the rotor unbalance and a balancing accuracy of 0.024 g mm kg−1 is achieved.

  3. Affectionate Writing Reduces Total Cholesterol: Two Randomized, Controlled Trials

    ERIC Educational Resources Information Center

    Floyd, Kory; Mikkelson, Alan C.; Hesse, Colin; Pauley, Perry M.

    2007-01-01

    In two 5-week trials, healthy college students were randomly assigned either to experimental or control groups. Participants in the experimental groups wrote about their affection for significant friends, relatives, and/or romantic partners for 20 minutes on three separate occasions; on the same schedule, those in the control groups wrote about…

  4. Passive drainage and biofiltration of landfill gas: Australian field trial

    SciTech Connect

    Dever, S.A. . E-mail: stuart_dever@ghd.com.au; Swarbrick, G.E. . E-mail: g.swarbrick@unsw.edu.au; Stuetz, R.M. . E-mail: r.stuetz@unsw.edu.au

    2007-07-01

    In Australia a significant number of landfill waste disposal sites do not incorporate measures for the collection and treatment of landfill gas. This includes many old/former landfill sites, rural landfill sites, non-putrescible solid waste and inert waste landfill sites, where landfill gas generation is low and it is not commercially viable to extract and beneficially utilize the landfill gas. Previous research has demonstrated that biofiltration has the potential to degrade methane in landfill gas, however, the microbial processes can be affected by many local conditions and factors including moisture content, temperature, nutrient supply, including the availability of oxygen and methane, and the movement of gas (oxygen and methane) to/from the micro-organisms. A field scale trial is being undertaken at a landfill site in Sydney, Australia, to investigate passive drainage and biofiltration of landfill gas as a means of managing landfill gas emissions at low to moderate gas generation landfill sites. The design and construction of the trial is described and the experimental results will provide in-depth knowledge on the application of passive gas drainage and landfill gas biofiltration under Sydney (Australian) conditions, including the performance of recycled materials for the management of landfill gas emissions.

  5. The Late Pretest Problem in Randomized Control Trials of Education Interventions. NCEE 2009-4033

    ERIC Educational Resources Information Center

    Schochet, Peter Z.

    2008-01-01

    Pretest-posttest experimental designs are often used in randomized control trials (RCTs) in the education field to improve the precision of the estimated treatment effects. For logistic reasons, however, pretest data are often collected after random assignment, so that including them in the analysis could bias the posttest impact estimates. Thus,…

  6. The Late Pretest Problem in Randomized Control Trials of Education Interventions

    ERIC Educational Resources Information Center

    Schochet, Peter Z.

    2010-01-01

    Pretest-posttest experimental designs often are used in randomized control trials (RCTs) in the education field to improve the precision of the estimated treatment effects. For logistic reasons, however, pretest data often are collected after random assignment, so that including them in the analysis could bias the posttest impact estimates. Thus,…

  7. The Sexunzipped Trial: Young People’s Views of Participating in an Online Randomized Controlled Trial

    PubMed Central

    Nicholas, Angela; Stevenson, Fiona; Murray, Elizabeth

    2013-01-01

    Background Incidence of sexually transmitted infections (STIs) among young people in the United Kingdom is increasing. The Internet can be a suitable medium for delivery of sexual health information and sexual health promotion, given its high usage among young people, its potential for creating a sense of anonymity, and ease of access. Online randomized controlled trials (RCTs) are increasingly being used to evaluate online interventions, but while there are many advantages to online methodologies, they can be associated with a number of problems, including poor engagement with online interventions, poor trial retention, and concerns about the validity of data collected through self-report online. We conducted an online feasibility trial that tested the effects of the Sexunzipped website for sexual health compared to an information-only website. This study reports on a qualitative evaluation of the trial procedures, describing participants’ experiences and views of the Sexunzipped online trial including methods of recruitment, incentives, methods of contact, and sexual health outcome measurement. Objective Our goal was to determine participants’ views of the acceptability and validity of the online trial methodology used in the pilot RCT of the Sexunzipped intervention. Methods We used three qualitative data sources to assess the acceptability and validity of the online pilot RCT methodology: (1) individual interviews with 22 participants from the pilot RCT, (2) 133 emails received by the trial coordinator from trial participants, and (3) 217 free-text comments from the baseline and follow-up questionnaires. Interviews were audio-recorded and transcribed verbatim. An iterative, thematic analysis of all three data sources was conducted to identify common themes related to the acceptability and feasibility of the online trial methodology. Results Interview participants found the trial design, including online recruitment via Facebook, online registration, email

  8. The CRASH trial: the first large-scale, randomised, controlled trial in head injury

    PubMed Central

    Roberts, Ian

    2001-01-01

    The global epidemic of head injuries is just beginning. Many are caused by road traffic crashes. It is estimated that, by 2020, road traffic crashes will have moved from its present position of ninth to third in the world disease burden ranking, as measured in disability adjusted life years. In developing countries, it will have moved to second. The Corticosteroid Randomisation After Significant Head Injury (CRASH) trial is a large-scale, randomised, controlled trial, among adults with head injury and impaired consciousness, of the effects of a short-term infusion of corticosteroids on death and on neurological disability. Following a successful pilot phase, which included over 1000 randomised participants, the main phase of the trial is now underway. Over the next 5 years, the trial aims to recruit a total of 20,000 patients. Such large numbers will only be possible if hundreds of doctors and nurses can collaborate in emergency departments all over the world. The trial is currently recruiting, and new collaborators are welcome to join the trial (see ). PMID:11737908

  9. Randomised controlled trials in primary care: scope and application.

    PubMed Central

    Sheikh, Aziz; Smeeth, Liam; Ashcroft, Richard

    2002-01-01

    There is now widespread acknowledgement of the absence of a sound evidence base underpinning many of the decisions made in primary care. Randomised controlled trials represent the methodology of choicefor determining efficacy and effectiveness of interventions, yet researchers working in primary care have been reluctant to use intervention studies, favouring observational study designs. Unfamiliarity with the different trial designs now available, and the relative advantages and disadvantages conferred by each, may be one factor contributing to this paradox. In this paper, we consider the principal trial designs available to primary care researchers, discussing the contexts in which a particular design may prove most useful. This information will, we hope, also prove useful to primary care clinicians attempting to interpret trial findings. PMID:12236280

  10. Prevention of abdominal wound infection (PROUD trial, DRKS00000390): study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Wound infection affects a considerable portion of patients after abdominal operations, increasing health care costs and postoperative morbidity and affecting quality of life. Antibacterial coating has been suggested as an effective measure to decrease postoperative wound infections after laparotomies. The INLINE metaanalysis has recently shown the superiority of a slowly absorbable continuous suture for abdominal closure; with PDS plus® such a suture has now been made available with triclosan antibacterial coating. Methods/Design The PROUD trial is designed as a randomised, controlled, observer, surgeon and patient blinded multicenter superiority trial with two parallel groups and a primary endpoint of wound infection during 30 days after surgery. The intervention group will receive triclosan coated polydioxanone sutures, whereas the control group will receive the standard polydioxanone sutures; abdominal closure will otherwise be standardized in both groups. Statistical analysis is based on intention-to-treat population via binary logistic regression analysis, the total sample size of n = 750 is sufficient to ensure alpha = 5% and power = 80%, an interim analysis will be carried out after data of 375 patients are available. Discussion The PROUD trial will yield robust data to determine the effectiveness of antibacterial coating in one of the standard sutures for abdominal closure and potentially lead to amendment of current guidelines. The exploration of clinically objective parameters as well as quality of life holds immediate relevance for clinical management and the pragmatic trial design ensures high external validity. Trial Registration The trial protocol has been registered with the German Clinical Trials Register (DRKS00000390). PMID:22103965

  11. Randomised Controlled Trials in Education Research: A Case Study of an Individually Randomised Pragmatic Trial

    ERIC Educational Resources Information Center

    Torgerson, Carole J.

    2009-01-01

    The randomised controlled trial (RCT) is an evaluative method used by social scientists in order to establish whether or not an intervention is effective. This contribution discusses the fundamental aspects of good RCT design. These are illustrated through the use of a recently completed RCT which evaluated an information and communication…

  12. Randomized Controlled Trials for the Treatment of Hidradenitis Suppurativa.

    PubMed

    van Rappard, Dominique C; Mekkes, Jan R; Tzellos, Thrasivoulos

    2016-01-01

    Hidradenitis suppurativa (HS) is a chronic, inflammatory, recurrent, debilitating skin disease. Several treatment modalities are available, but most of them lack high-quality evidence. A systematic search was performed to identify all randomized controlled trials for the treatment of HS in order to review and evaluate the evidence. Recommendations for future randomized controlled trials include using validated scores, inclusion of patient rated outcomes, and thorough report of side effects. Evidence for long-term treatment and benefit/risk ratio of available treatment modalities is needed in order to enhance evidence-based treatment in daily clinical practice. Combining surgery with antiinflammatory treatment warrants further investigation.

  13. Canadian Optically-guided approach for Oral Lesions Surgical (COOLS) trial: study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Oral cancer is a major health problem worldwide. The 5-year survival rate ranges from 30-60%, and has remained unchanged in the past few decades. This is mainly due to late diagnosis and high recurrence of the disease. Of the patients who receive treatment, up to one third suffer from a recurrence or a second primary tumor. It is apparent that one major cause of disease recurrence is clinically unrecognized field changes which extend beyond the visible tumor boundary. We have previously developed an approach using fluorescence visualization (FV) technology to improve the recognition of the field at risk surrounding a visible oral cancer that needs to be removed and preliminary results have shown a significant reduction in recurrence rates. Method/Design This paper describes the study design of a randomized, multi-centre, double blind, controlled surgical trial, the COOLS trial. Nine institutions across Canada will recruit a total of 400 patients with oral severe dysplasia or carcinoma in situ (N = 160) and invasive squamous cell carcinoma (N = 240). Patients will be stratified by participating institution and histology grade and randomized equally into FV-guided surgery (experimental arm) or white light-guided surgery (control arm). The primary endpoint is a composite of recurrence at or 1 cm within the previous surgery site with 1) the same or higher grade histology compared to the initial diagnosis (i.e., the diagnosis used for randomization); or 2) further treatment due to the presence of severe dysplasia or higher degree of change at follow-up. This is the first randomized, multi-centre trial to validate the effectiveness of the FV-guided surgery. Discussion In this paper we described the strategies, novelty, and challenges of this unique trial involving a surgical approach guided by the FV technology. The success of the trial requires training, coordination, and quality assurance across multiple sites within Canada. The COOLS trial, an example of

  14. Placebo controlled trials in neuromyelitis optica are needed and ethical.

    PubMed

    Cree, Bruce A C

    2015-11-01

    Currently, there are no approved treatments for NMO. All therapeutic studies in NMO have been either small, retrospective case series or uncontrolled prospective studies. Such studies are susceptible to inherent biases. As a consequence, conclusions regarding efficacy and safety from these studies may be erroneous. The optimal method for assessing therapeutic efficacy is the prospective, controlled trial with random treatment assignment that has the potential to control for multiple sources of bias. There is a significant unmet need for well-designed clinical trials in NMO. Successfully conducted, well-controlled NMO trials that show proof of benefit will lead to regulatory approval and subsequent acceptance by payers resulting in broad therapeutic availability. The most direct method to prove efficacy is to compare an active treatment vs. no treatment or placebo control. However, because of the devastating nature of the disease some clinicians are reluctant to expose potential study patients to the risk of no treatment. The primary ethical concern in the case of placebo-control in NMO clinical trials rests on the relative merits of answering the scientific question regarding efficacy compared to the relative risk of exposure to harm in the placebo-control group. This article outlines the case for clinical equipoise in NMO by addressing the uncertainty regarding the relative scientific and clinical merits of current empirically used treatments and showing that a placebo arm is consistent with competent medical care. Because no currently available treatment has proven benefit, and because all therapies are known to potentially cause harm, placebo-control is not only ethical but is in some ways preferable to active comparator or add-on study designs. Without well-designed, placebo-controlled trials, NMO patients may not have access to new treatments and will never know whether the therapies that they may be currently taking have risk to benefit profiles that clearly

  15. Controlled trial of Penfluridol in Acute Psychosis

    PubMed Central

    van Praag, H. M.; Schut, T.; Dols, L.; van Schilfgaarden, R.

    1971-01-01

    A controlled study was made of penfluridol medication consisting of a single weekly oral dose of 30 mg in 30 patients with acute psychoses of varying type and origin. This medication was found to be effective. No significant side effects occurred. Several long-acting neuroleptics for injection are now available. The development of an oral compound of this type is an asset because of the manageability of the oral drug in the hands of family doctors and social psychiatrists. PMID:4943034

  16. Randomized controlled trials – a matter of design

    PubMed Central

    Spieth, Peter Markus; Kubasch, Anne Sophie; Penzlin, Ana Isabel; Illigens, Ben Min-Woo; Barlinn, Kristian; Siepmann, Timo

    2016-01-01

    Randomized controlled trials (RCTs) are the hallmark of evidence-based medicine and form the basis for translating research data into clinical practice. This review summarizes commonly applied designs and quality indicators of RCTs to provide guidance in interpreting and critically evaluating clinical research data. It further reflects on the principle of equipoise and its practical applicability to clinical science with an emphasis on critical care and neurological research. We performed a review of educational material, review articles, methodological studies, and published clinical trials using the databases MEDLINE, PubMed, and ClinicalTrials.gov. The most relevant recommendations regarding design, conduction, and reporting of RCTs may include the following: 1) clinically relevant end points should be defined a priori, and an unbiased analysis and report of the study results should be warranted, 2) both significant and nonsignificant results should be objectively reported and published, 3) structured study design and performance as indicated in the Consolidated Standards of Reporting Trials statement should be employed as well as registration in a public trial database, 4) potential conflicts of interest and funding sources should be disclaimed in study report or publication, and 5) in the comparison of experimental treatment with standard care, preplanned interim analyses during an ongoing RCT can aid in maintaining clinical equipoise by assessing benefit, harm, or futility, thus allowing decision on continuation or termination of the trial. PMID:27354804

  17. A randomised controlled trial of treatment for idiopathic intracranial hypertension.

    PubMed

    Ball, Alexandra K; Howman, Andrew; Wheatley, Keith; Burdon, Michael A; Matthews, Timothy; Jacks, Andrew S; Lawden, Mark; Sivaguru, Arul; Furmston, Alexandra; Howell, Steven; Sharrack, Basil; Davies, M Brendan; Sinclair, Alexandra J; Clarke, Carl E

    2011-05-01

    The cause of idiopathic intracranial hypertension (IIH) remains unknown, and no consensus exists on how patients should be monitored and treated. Acetazolamide is a common treatment but has never been examined in a randomised controlled trial. The objectives of this pilot trial are to prospectively evaluate the use of acetazolamide, to explore various outcome measures and to inform the design of a definitive trial in IIH. Fifty patients were recruited from six centres over 23 months and randomised to receive acetazolamide (n = 25) or no acetazolamide (n = 25). Symptoms, body weight, visual function and health-related quality-of-life measures were recorded over a 12-month period. Recruited patients had typical features of mild IIH and most showed improvement, with 44% judged to have IIH in remission at the end of the trial. Difficulties with recruitment were highlighted as well as poor compliance with acetazolamide therapy (12 patients). A composite measure of IIH status was tested, and the strongest concordance with final disease status was seen with perimetry (Somers' D = 0.66) and optic disc appearance (D = 0.59). Based on the study data, a sample size of 320 would be required to demonstrate a 20% treatment effect in a substantive trial. Clinical trials in IIH require pragmatic design to involve sufficiently large numbers of patients. Future studies should incorporate weighted composite scores to reflect the relative importance of common outcome measures in IIH.

  18. Using Randomized Controlled Trials to Evaluate Interventions for Releasing Prisoners

    ERIC Educational Resources Information Center

    Pettus-Davis, Carrie; Howard, Matthew Owen; Dunnigan, Allison; Scheyett, Anna M.; Roberts-Lewis, Amelia

    2016-01-01

    Randomized controlled trials (RCTs) are rarely used to evaluate social and behavioral interventions designed for releasing prisoners. Objective: We use a pilot RCT of a social support intervention (Support Matters) as a case example to discuss obstacles and strategies for conducting RCT intervention evaluations that span prison and community…

  19. A controlled trial of ambroxol in chronic bronchitis.

    PubMed

    Guyatt, G H; Townsend, M; Kazim, F; Newhouse, M T

    1987-10-01

    Ambroxol is a mucolytic agent which is widely used in chronic bronchitis in Europe. We conducted a double-blind randomized controlled trial of ambroxol vs matched placebo in 90 patients with chronic bronchitis and difficulty clearing secretions. It was concluded that there was no advantage to taking ambroxol.

  20. Outcomes in a Randomised Controlled Trial of Mathematics Tutoring

    ERIC Educational Resources Information Center

    Topping, K. J.; Miller, D.; Murray, P.; Henderson, S.; Fortuna, C.; Conlin, N.

    2011-01-01

    Background: Large-scale randomised controlled trials (RCT) are relatively rare in education. The present study was an attempt to scale up previous small peer tutoring projects, while investing only modestly in continuing professional development for teachers. Purpose: A two-year RCT of peer tutoring in mathematics was undertaken in one local…

  1. A Randomized Controlled Trial of Two Online Mathematics Curricula

    ERIC Educational Resources Information Center

    Wang, Haiwen; Woodworth, Katrina

    2011-01-01

    This study applies a randomized controlled trial to examine the effects of supplemental instruction using two online mathematics curricula--DreamBox and Reasoning Mind. It is an independent evaluation intended to generate unbiased results that will help inform the ongoing development of a charter school network's hybrid instructional model, which…

  2. Controlled trial of an electrostatic precipitator in childhood asthma.

    PubMed

    Mitchell, E A; Elliott, R B

    1980-09-13

    A cross-over trial was conducted on 10 children with moderate to severe asthma, who had positive skin tests to Dermatophagoides pteronyssinus and nocturnal wheeze. An electrostatic precipitator was used during the night to remove airborne particles from the bedroom. During use of the precipitator peak expiratory flow rates were no better than in a control period.

  3. Franklin, Lavoisier, and Mesmer: origin of the controlled clinical trial.

    PubMed

    Herr, Harry W

    2005-01-01

    In 1784, a Royal Commission headed by Benjamin Franklin and Antoine Lavoisier designed a series of ingenious experiments to debunk France's greatest medical rogue, Anton Mesmer, and his bizarre healing of illnesses based on his bogus theory of animal magnetism. Using intentional subject ignorance and sham interventions to investigate mesmerism, Franklin's commission provided a model for the controlled clinical trial. PMID:16144669

  4. Franklin, Lavoisier, and Mesmer: origin of the controlled clinical trial.

    PubMed

    Herr, Harry W

    2005-01-01

    In 1784, a Royal Commission headed by Benjamin Franklin and Antoine Lavoisier designed a series of ingenious experiments to debunk France's greatest medical rogue, Anton Mesmer, and his bizarre healing of illnesses based on his bogus theory of animal magnetism. Using intentional subject ignorance and sham interventions to investigate mesmerism, Franklin's commission provided a model for the controlled clinical trial.

  5. Field trial of a pulsed limestone diversion well

    USGS Publications Warehouse

    Sibrell, Philip L.; Denholm, C.; Dunn, Margaret

    2013-01-01

    The use of limestone diversion wells to treat acid mine drainage (AMD) is well-known, but in many cases, acid neutralization is not as complete as would be desired. Reasons for this include channeling of the water through the limestone bed, and the slow reaction rate of the limestone gravel. A new approach to improve the performance of the diversion well was tested in the field at the Jennings Environmental Education Center, near Slippery Rock, PA. In this approach, a finer size distribution of limestone was used so as to allow fluidization of the limestone bed, thus eliminating channeling and increasing particle surface area for faster reaction rates. Also, water flow was regulated through the use of a dosing siphon, so that consistent fluidization of the limestone sand could be achieved. Testing began late in the summer of 2010, and continued through November of 2011. Initial system performance during the 2010 field season was good, with the production of net alkaline water, but hydraulic problems involving air release and limestone sand retention were observed. In the summer of 2011, a finer size of limestone sand was procured for use in the system. This material fluidized more readily, but acid neutralization tapered off after several days. Subsequent observations indicated that the hydraulics of the system was compromised by the formation of iron oxides in the pipe leading to the limestone bed, which affected water distribution and flow through the bed. Although results from the field trial were mixed, it is believed that without the formation of iron oxides and plugging of the pipe, better acid neutralization and treatment would have occurred. Further tests are being considered using a different hydraulic configuration for the limestone sand fluidized bed.

  6. UK Dermatology Clinical Trials Network’s STOP GAP trial (a multicentre trial of prednisolone versus ciclosporin for pyoderma gangrenosum): protocol for a randomised controlled trial

    PubMed Central

    2012-01-01

    Background Pyoderma gangrenosum (PG) is a rare inflammatory skin disorder characterised by painful and rapidly progressing skin ulceration. PG can be extremely difficult to treat and patients often require systemic immunosuppression. Recurrent lesions of PG are common, but the relative rarity of this condition means that there is a lack of published evidence regarding its treatment. A systematic review published in 2005 found no randomised controlled trials (RCTs) relating to the treatment of PG. Since this time, one small RCT has been published comparing infliximab to placebo, but none of the commonly used systemic treatments for PG have been formally assessed. The UK Dermatology Clinical Trials Network’s STOP GAP Trial has been designed to address this lack of trial evidence. Methods The objective is to assess whether oral ciclosporin is more effective than oral prednisolone for the treatment of PG. The trial design is a two-arm, observer-blind, parallel-group, randomised controlled trial comparing ciclosporin (4 mg/kg/day) to prednisolone (0.75 mg/kg/day). A total of 140 participants are to be recruited over a period of 4 years, from up to 50 hospitals in the UK and Eire. Primary outcome of velocity of healing at 6 weeks is assessed blinded to treatment allocation (using digital images of the ulcers). Secondary outcomes include: (i) time to healing; (ii) global assessment of improvement; (iii) PG inflammation assessment scale score; (iv) self-reported pain; (v) health-related quality of life; (vi) time to recurrence; (vii) treatment failures; (viii) adverse reactions to study medications; and (ix) cost effectiveness/utility. Patients with a clinical diagnosis of PG (excluding granulomatous PG); measurable ulceration (that is, not pustular PG); and patients aged over 18 years old who are able to give informed consent are included in the trial. Randomisation is by computer generated code using permuted blocks of randomly varying size, stratified by

  7. Randomized controlled trial design in rheumatoid arthritis: the past decade

    PubMed Central

    Strand, Vibeke; Sokolove, Jeremy

    2009-01-01

    Much progress has occurred over the past decade in rheumatoid arthritis trial design. Recognized challenges have led to the establishment of a clear regulatory pathway to demonstrate efficacy of a new therapeutic. The use of pure placebo beyond 12 to 16 weeks has been demonstrated to be unethical and thus background therapy and/or early rescue has become regular practice. Goals of remission and 'treating to targets' may prove more relevant to identify real-world use of new and existing therapeutics. Identification of rare adverse events associated with new therapies has resulted in intensive safety evaluation during randomized controlled trials and emphasis on postmarketing surveillance and use of registries. PMID:19232061

  8. Randomized controlled trials and challenge trials: design and criterion for validity.

    PubMed

    Sargeant, J M; Kelton, D F; O'Connor, A M

    2014-06-01

    This article is the third of six articles addressing systematic reviews in animal agriculture and veterinary medicine. This article provides an overview of clinical trials, both randomized controlled trials (RCTs) and challenge trials, where the disease outcome is deliberately induced by the investigator. RCTs are not the only study design used in systematic reviews, but are preferred when available as the gold standard for evaluating interventions under real-world conditions. RCTs are planned experiments, which involve diseased or at-risk study subjects and are designed to evaluate interventions (therapeutic treatments or preventive strategies, including antibiotics, vaccines, management practices, dietary changes, management changes or lifestyle changes). Key components of the RCT are the use of one or more comparison (control) groups and investigator control over intervention allocation. Important design features in RCTs include as follows: how the population is selected, approach to allocation of intervention and control group subjects, how allocation is concealed prior to enrolment of study subjects, how outcomes are defined, how allocation to group is concealed (blinding) and how withdrawals from the study are managed. Guidelines for reporting important features of RCTs have been published and are useful tools for writing, reviewing and reading reports of RCTs. PMID:24905993

  9. Calculating Sample Size in Trials Using Historical Controls

    PubMed Central

    Zhang, Song; Cao, Jing; Ahn, Chul

    2011-01-01

    Background Makuch and Simon [1] developed a sample size formula for historical control trials. When assessing power, they assumed the true control treatment effect to be equal to the observed effect from the historical control group. Many researchers have pointed out that the M-S approach does not preserve the nominal power and type I error when considering the uncertainty in the true historical control treatment effect. Purpose To develop a sample size formula that properly accounts for the underlying randomness in the observations from the historical control group. Methods We reveal the extremely skewed nature in the distributions of power and type I error, obtained over all the random realizations of the historical control data. The skewness motivates us to derive a sample size formula that controls the percentiles, instead of the means, of the power and type I error. Results A closed-form sample size formula is developed to control arbitrary percentiles of power and type I error for historical control trials. A simulation study further demonstrates that this approach preserves the operational characteristics in a more realistic scenario where the population variances are unknown and replaced by sample variances. Limitations The closed-form sample size formula is derived for continuous outcomes. The formula is more complicated for binary or survival time outcomes. Conclusions We have derived a closed-form sample size formula that controls the percentiles instead of means of power and type I error in historical control trials, which have extremely skewed distributions over all the possible realizations of historical control data. PMID:20573638

  10. The Cessation in Pregnancy Incentives Trial (CPIT): study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Seventy percent of women in Scotland have at least one baby, making pregnancy an opportunity to help most young women quit smoking before their own health is irreparably compromised. By quitting during pregnancy their infants will be protected from miscarriage and still birth as well as low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. In the UK, the NICE guidelines: ‘How to stop smoking in pregnancy and following childbirth’ (June 2010) highlighted that little evidence exists in the literature to confirm the efficacy of financial incentives to help pregnant smokers to quit. Its first research recommendation was to determine: Within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit? Design and methods This study is a phase II exploratory individually randomized controlled trial comparing standard care for pregnant smokers with standard care plus the additional offer of financial voucher incentives to engage with specialist cessation services and/or to quit smoking during pregnancy. Participants (n = 600) will be pregnant smokers identified at maternity booking who, when contacted by specialist cessation services, agree to having their details passed to the NHS Smokefree Pregnancy Study Helpline to discuss the trial. The NHS Smokefree Pregnancy Study Helpline will be responsible for telephone consent and follow-up in late pregnancy. The primary outcome will be self reported smoking in late pregnancy verified by cotinine measurement. An economic evaluation will refine cost data collection and assess potential cost-effectiveness while qualitative research interviews with clients and health professionals will assess the level of acceptance of this form of incentive payment. The research questions are: What is the likely therapeutic efficacy? Are incentives potentially cost-effective? Is individual randomization an efficient trial design without

  11. Premium performance heating oil - Part 2, Field trial results

    SciTech Connect

    Jetter, S.M.; Hoskin, D.; McClintock, W.R.

    1996-07-01

    Limited field trial results of a heating oil additive package developed to minimize unscheduled maintenance indicate that it achieves its goal of keeping heating oil systems cleaner. The multifunctional additive package was developed to provide improved fuel oxidation stability, improved corrosion protection, and dispersency. This combination of performance benefits was chosen because we believed it would retard the formation of sludge, as well as allow sludge already present to be carried through the system without fouling the fuel system components (dispersency should keep sludge particles small so they pass through the filtering system). Since many unscheduled maintenance calls are linked to fouling of the fuel filtering system, the overall goal of this technology is to reduce these maintenance calls. Photographic evidence shows that the additive package not only reduces the amount of sludge formed, but even removes existing sludge from filters and pump strainers. This {open_quotes}clean-up{close_quotes} performance is provided trouble free: we found no indication that nozzle/burner performance was impaired by dispersing sludge from filters and pump strainers. Qualitative assessments from specific accounts that used the premium heating oil also show marked reductions in unscheduled maintenance.

  12. Electro-chemical arsenic remediation: field trials in West Bengal.

    PubMed

    Amrose, Susan E; Bandaru, Siva R S; Delaire, Caroline; van Genuchten, Case M; Dutta, Amit; DebSarkar, Anupam; Orr, Christopher; Roy, Joyashree; Das, Abhijit; Gadgil, Ashok J

    2014-08-01

    Millions of people in rural South Asia are exposed to high levels of arsenic through groundwater used for drinking. Many deployed arsenic remediation technologies quickly fail because they are not maintained, repaired, accepted, or affordable. It is therefore imperative that arsenic remediation technologies be evaluated for their ability to perform within a sustainable and scalable business model that addresses these challenges. We present field trial results of a 600 L Electro-Chemical Arsenic Remediation (ECAR) reactor operating over 3.5 months in West Bengal. These results are evaluated through the lens of a community scale micro-utility business model as a potential sustainable and scalable safe water solution for rural communities in South Asia. We demonstrate ECAR's ability to consistently reduce arsenic concentrations of ~266 μg/L to <5 μg/L in real groundwater, simultaneously meeting the international standards for iron and aluminum in drinking water. ECAR operating costs (amortized capital plus consumables) are estimated as $0.83-$1.04/m(3) under realistic conditions. We discuss the implications of these results against the constraints of a sustainable and scalable business model to argue that ECAR is a promising technology to help provide a clean water solution in arsenic-affected areas of South Asia.

  13. Randomized Controlled Trials of Add-On Antidepressants in Schizophrenia

    PubMed Central

    Joffe, Grigori; Stenberg, Jan-Henry

    2015-01-01

    Background: Despite adequate treatment with antipsychotics, a substantial number of patients with schizophrenia demonstrate only suboptimal clinical outcome. To overcome this challenge, various psychopharmacological combination strategies have been used, including antidepressants added to antipsychotics. Methods: To analyze the efficacy of add-on antidepressants for the treatment of negative, positive, cognitive, depressive, and antipsychotic-induced extrapyramidal symptoms in schizophrenia, published randomized controlled trials assessing the efficacy of adjunctive antidepressants in schizophrenia were reviewed using the following parameters: baseline clinical characteristics and number of patients, their on-going antipsychotic treatment, dosage of the add-on antidepressants, duration of the trial, efficacy measures, and outcomes. Results: There were 36 randomized controlled trials reported in 41 journal publications (n=1582). The antidepressants used were the selective serotonin reuptake inhibitors, duloxetine, imipramine, mianserin, mirtazapine, nefazodone, reboxetin, trazodone, and bupropion. Mirtazapine and mianserin showed somewhat consistent efficacy for negative symptoms and both seemed to enhance neurocognition. Trazodone and nefazodone appeared to improve the antipsychotics-induced extrapyramidal symptoms. Imipramine and duloxetine tended to improve depressive symptoms. No clear evidence supporting selective serotonin reuptake inhibitors’ efficacy on any clinical domain of schizophrenia was found. Add-on antidepressants did not worsen psychosis. Conclusions: Despite a substantial number of randomized controlled trials, the overall efficacy of add-on antidepressants in schizophrenia remains uncertain mainly due to methodological issues. Some differences in efficacy on several schizophrenia domains seem, however, to exist and to vary by the antidepressant subgroups—plausibly due to differences in the mechanisms of action. Antidepressants may not worsen

  14. First Field Trial of Optical Label-Based Switching and Packet Drop on a 477km NTON/Sprint Link

    SciTech Connect

    Hernandez, V J; Pan, Z; Cao, J; Tsui, V K; Bansal, Y; Fong, S K H; Zhang, Y; Jeon, M Y; Yoo, S J B; Bodtker, B; Bond, S; Lennon, W J; Higashi, H; Lyles, B; McDonald, R

    2001-12-10

    We demonstrate the first field trial of optical label-based wavelength switching and packet drop on 476.8km of the National Transparent Optical Network. Subcarrier multiplexed labels control a switch fabric that includes a tunable wavelength converter and arrayed waveguide grating router.

  15. HEP (hydraulic, electronic, pneumatic) pumping unit: performance characteristics, potential applications, and field trial results

    SciTech Connect

    Jesperson, P.J.; Laidlaw, R.N.; Scott, R.J.

    1981-01-01

    THe HEP pumping unit constitutes an alternative to the familiar beam pumping unit as a means of transferring energy from the prime mover to the sucker rod string of a pumping well. This paper addresses some basic concepts which are part of the HEP system design and describes some of the resultant unit performance characteristics. The potential for enhancement of pumping well operations utilizing the high degree of control over rod string motion attainable with the HEP system, is discussed together with the results of a number of field trials and some plans for further unit evaluation and development. A lift capacity comparison with conventional beam pumping units is also included. 8 refs.

  16. Magnetic field control. [electromechanical torquing device

    NASA Technical Reports Server (NTRS)

    Haeussermann, W. (Inventor)

    1982-01-01

    A torque control for an electromechanical torquing device of a type where a variable clearance occurs between a rotor and field is described. A Hall effect device senses the field present, which would vary as a function of spacing between field and rotor. The output of the Hall effect device controls the power applied to the field so as to provide a well defined field and thus a controlled torque to the rotor which is well defined.

  17. The Beta Agonist Lung Injury Trial Prevention. A Randomized Controlled Trial

    PubMed Central

    Gates, Simon; Park, Daniel; Gao, Fang; Knox, Chris; Holloway, Ben; McAuley, Daniel F.; Ryan, James; Marzouk, Joseph; Cooke, Matthew W.; Lamb, Sarah E.; Thickett, David R.

    2014-01-01

    Rationale: Experimental studies suggest that pretreatment with β-agonists might prevent acute lung injury (ALI). Objectives: To determine if in adult patients undergoing elective esophagectomy, perioperative treatment with inhaled β-agonists effects the development of early ALI. Methods: We conducted a randomized placebo-controlled trial in 12 UK centers (2008–2011). Adult patients undergoing elective esophagectomy were allocated to prerandomized, sequentially numbered treatment packs containing inhaled salmeterol (100 μg twice daily) or a matching placebo. Patients, clinicians, and researchers were masked to treatment allocation. The primary outcome was development of ALI within 72 hours of surgery. Secondary outcomes were ALI within 28 days, organ failure, adverse events, survival, and health-related quality of life. An exploratory substudy measured biomarkers of alveolar-capillary inflammation and injury. Measurements and Main Results: A total of 179 patients were randomized to salmeterol and 183 to placebo. Baseline characteristics were similar. Treatment with salmeterol did not prevent early lung injury (32 [19.2%] of 168 vs. 27 [16.0%] of 170; odds ratio [OR], 1.25; 95% confidence interval [CI], 0.71–2.22). There was no difference in organ failure, survival, or health-related quality of life. Adverse events were less frequent in the salmeterol group (55 vs. 70; OR, 0.63; 95% CI, 0.39–0.99), predominantly because of a lower number of pneumonia (7 vs. 17; OR, 0.39; 95% CI, 0.16–0.96). Salmeterol reduced some biomarkers of alveolar inflammation and epithelial injury. Conclusion: Perioperative treatment with inhaled salmeterol was well tolerated but did not prevent ALI. Clinical trial registered with International Standard Randomized Controlled Trial Register (ISRCTN47481946) and European Union database of randomized Controlled Trials (EudraCT 2007-004096-19). PMID:24392848

  18. Overview of the Full-scale Radiological Dispersal Device Field Trials.

    PubMed

    Green, Anna Rae; Erhardt, Lorne; Lebel, Luke; Duke, M John M; Jones, Trevor; White, Dan; Quayle, Debora

    2016-05-01

    In 2012, Defence Research and Development Canada, in partnership with a number of other Canadian and International organizations, led a series of three field trials designed to simulate a Radiological Dispersal Device (RDD). These trials, known as the Full-Scale RDD (FSRDD) Field Trials, involved the explosive dispersal of a short-lived radioactive tracer ((140)La, t1/2 = 40.293 h). The FSRDD Field Trials required a significant effort in their planning, preparation, and execution to ensure that they were carried out in a safe, efficient manner and that the scientific goals of the trials were met. The discussion presented here details the planning and execution of the trials, outlines the relevant radiation safety aspects, provides a summary of the source term and atmospheric conditions for the three dispersal events, and provides an overview of the measurements that were made to track the plumes and deposition patterns.

  19. The Sexunzipped Trial: Optimizing the Design of Online Randomized Controlled Trials

    PubMed Central

    Pavlou, Menelaos; Copas, Andrew; McCarthy, Ona; Carswell, Ken; Rait, Greta; Hart, Graham; Nazareth, Irwin; Free, Caroline; French, Rebecca; Murray, Elizabeth

    2013-01-01

    Background Sexual health problems such as unwanted pregnancy and sexually transmitted infection are important public health concerns and there is huge potential for health promotion using digital interventions. Evaluations of digital interventions are increasingly conducted online. Trial administration and data collection online offers many advantages, but concerns remain over fraudulent registration to obtain compensation, the quality of self-reported data, and high attrition. Objective This study addresses the feasibility of several dimensions of online trial design—recruitment, online consent, participant identity verification, randomization and concealment of allocation, online data collection, data quality, and retention at 3-month follow-up. Methods Young people aged 16 to 20 years and resident in the United Kingdom were recruited to the “Sexunzipped” online trial between November 2010 and March 2011 (n=2036). Participants filled in baseline demographic and sexual health questionnaires online and were randomized to the Sexunzipped interactive intervention website or to an information-only control website. Participants were also randomly allocated to a postal request (or no request) for a urine sample for genital chlamydia testing and receipt of a lower (£10/US$16) or higher (£20/US$32) value shopping voucher compensation for 3-month outcome data. Results The majority of the 2006 valid participants (90.98%, 1825/2006) were aged between 18 and 20 years at enrolment, from all four countries in the United Kingdom. Most were white (89.98%, 1805/2006), most were in school or training (77.48%, 1545/1994), and 62.81% (1260/2006) of the sample were female. In total, 3.88% (79/2036) of registrations appeared to be invalid and another 4.00% (81/2006) of participants gave inconsistent responses within the questionnaire. The higher value compensation (£20/US$32) increased response rates by 6-10%, boosting retention at 3 months to 77.2% (166/215) for submission of

  20. DC-based magnetic field controller

    DOEpatents

    Kotter, D.K.; Rankin, R.A.; Morgan, J.P.

    1994-05-31

    A magnetic field controller is described for laboratory devices and in particular to dc operated magnetic field controllers for mass spectrometers, comprising a dc power supply in combination with improvements to a Hall probe subsystem, display subsystem, preamplifier, field control subsystem, and an output stage. 1 fig.

  1. DC-based magnetic field controller

    DOEpatents

    Kotter, Dale K.; Rankin, Richard A.; Morgan, John P,.

    1994-01-01

    A magnetic field controller for laboratory devices and in particular to dc operated magnetic field controllers for mass spectrometers, comprising a dc power supply in combination with improvements to a hall probe subsystem, display subsystem, preamplifier, field control subsystem, and an output stage.

  2. Not a load of rubbish: simulated field trials in large-scale containers.

    PubMed

    Hohmann, M; Stahl, A; Rudloff, J; Wittkop, B; Snowdon, R J

    2016-09-01

    Assessment of yield performance under fluctuating environmental conditions is a major aim of crop breeders. Unfortunately, results from controlled-environment evaluations of complex agronomic traits rarely translate to field performance. A major cause is that crops grown over their complete lifecycle in a greenhouse or growth chamber are generally constricted in their root growth, which influences their response to important abiotic constraints like water or nutrient availability. To overcome this poor transferability, we established a plant growth system comprising large refuse containers (120 L 'wheelie bins') that allow detailed phenotyping of small field-crop populations under semi-controlled growth conditions. Diverse winter oilseed rape cultivars were grown at field densities throughout the crop lifecycle, in different experiments over 2 years, to compare seed yields from individual containers to plot yields from multi-environment field trials. We found that we were able to predict yields in the field with high accuracy from container-grown plants. The container system proved suitable for detailed studies of stress response physiology and performance in pre-breeding populations. Investment in automated large-container systems may help breeders improve field transferability of greenhouse experiments, enabling screening of pre-breeding materials for abiotic stress response traits with a positive influence on yield. PMID:27144906

  3. Randomized Controlled Trials in Health Technology Assessment: Overkill or Overdue?

    PubMed Central

    Bentzen, Søren M.

    2012-01-01

    Evidence-based medicine has become a cornerstone in the development of radiation oncology and the randomized controlled phase III trial remains the gold standard for assessing differential benefits in clinical outcome between therapies. Health technologies aimed at improving treatment quality should primarily be tested using process measures or operational characteristics, the reason being that the sensitivity and specificity of clinical outcome is low for detecting quality improvements. The ongoing discussion of the relative merits of intensity modulated photon vs. proton radiotherapy is used to illustrate these concepts. Concerns over clinical and individual equipoise as well as the potential limitations of health economics considerations in this setting are also discussed. Working in a technology and science based medical discipline, radiation oncology researchers need to further develop methodology for critical assessment of health technologies as a complement to randomized controlled trials. PMID:18237799

  4. Disclosing the potential impact of placebo controls in antidepressant trials

    PubMed Central

    Chen, Stephanie C.; McCullumsmith, Cheryl

    2015-01-01

    Background Although placebo-control clinical trials that withhold effective treatments can be permissible, how best to inform participants of the placebo design has received little attention. Aims To determine the effect of disclosing quantitative outcome estimates of individual treatment v. entering placebo-control randomised control trial (RCT) on willingness to enrol in such an RCT. Method We randomised 278 adult patients at a depression clinic to receive standard disclosure (n = 129) or enhanced (n = 149) quantitative outcome estimates (based on decision analysis) of individual treatment v. RCT, and assessed their willingness to enrol in the RCT. Results A greater proportion of those in the standard arm preferred enrolling in RCT (41.3% v. 23.8%, P = 0.002). Those in the standard arm preferred RCT more for direct benefit than altruism reasons, whereas the opposite was true in the enhanced arm. Conclusions Disclosing the quantitative outcome implications of placebos may select for fewer but more altruistic participants. Declaration of interest S.Y.H.K. was a DSMB member of a clinical trial sponsored by Hoffman-LaRoche and he receives royalties from Oxford University Press for his book Evaluation of Capacity to Consent to Treatment and Research. C.M. has served in the past year on a scientific advisory board and as a consultant for Janssen Pharmaceuticals. Copyright and usage This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) licence. PMID:27703715

  5. Randomized controlled trials to assess therapies for multiple sclerosis.

    PubMed

    Wingerchuk, Dean M; Noseworthy, John H

    2002-04-23

    MS poses formidable challenges to clinical investigators. Obstacles to the study of MS therapies include disease chronicity, an unpredictable clinical course, radiologic and pathologic heterogeneity, and limited understanding of the underlying pathophysiology. Randomized controlled trials (RCTs) provide a means to assess therapeutic efficacy while reducing the risks of study bias and confounding factors that influence interpretation of results. RCTs have demonstrated that type 1 interferons and glatiramer acetate alter the short-term natural history of MS and have served as the basis of approval for the marketing of these treatments. Improvements and optimization of trial methodology may hasten the discovery of effective therapies and facilitate better comparisons of the results of individual drug trials. The most urgent need is for improved surrogate end points for clinical outcome with predictive validity for long-term disability. Even if RCT methodology is optimal, however, several limitations inherent to MS trials threaten to impede further progress, including obstacles to long-term studies (e.g., costs), patient withdrawal, and escalating sample size requirements to detect partial therapeutic benefit. There is a crucial need to develop alternative investigative methods, possibly through enhanced collaboration across centers and with industry, and by exploring innovative techniques to use existing RCT and natural history databases to greater advantage.

  6. Should desperate volunteers be included in randomised controlled trials?

    PubMed

    Allmark, P; Mason, S

    2006-09-01

    Randomised controlled trials (RCTs) sometimes recruit participants who are desperate to receive the experimental treatment. This paper defends the practice against three arguments that suggest it is unethical first, desperate volunteers are not in equipoise. Second clinicians, entering patients onto trials are disavowing their therapeutic obligation to deliver the best treatment; they are following trial protocols rather than delivering individualised care. Research is not treatment; its ethical justification is different. Consent is crucial. Third, desperate volunteers do not give proper consent: effectively, they are coerced. This paper responds by advocating a notion of equipoise based on expert knowledge and widely shared values. Where such collective, expert equipoise exists there is a prima facie case for an RCT. Next the paper argues that trial entry does not involve clinicians disavowing their therapeutic obligation; individualised care based on insufficient evidence is not in patients best interest. Finally, it argues that where equipoise exists it is acceptable to limit access to experimental agents; desperate volunteers are not coerced because their desperation does not translate into a right to receive what they desire.

  7. Randomized control trial of computer-based rehabilitation of spatial neglect syndrome: the RESPONSE trial protocol

    PubMed Central

    2014-01-01

    Background Spatial neglect is a frequent and debilitating consequence of acquired brain injury and currently has no widely accepted standard of care. While previous interventions for spatial neglect have targeted patients’ overt spatial deficits (e.g., reduced contralesional visual scanning), far fewer have directly targeted patients’ non-spatial deficits (e.g., sustained attention deficits). Considering that non-spatial deficits have shown to be highly predictive of long-term disability, we developed a novel computer based training program that targets both sustained (tonic) and moment-to-moment (phasic) aspects of non-spatial attention (Tonic and Phasic Alertness Training, TAPAT). Preliminary studies demonstrate that TAPAT is safe and effective in improving both spatial and non-spatial attention deficits in the post-acute recovery phase in neglect patients. The purpose of the current trial (referred to as the REmediation of SPatial Neglect or RESPONSE trial) is to compare TAPAT to an active control training condition, include a larger sample of patients, and assess both cognitive and functional outcomes. Methods/Design We will employ a multi-site, longitudinal, blinded randomized controlled trial (RCT) design with a target sample of 114 patients with spatial neglect. Patients will either perform, at their home, the experimental TAPAT training program or an active control computer games condition for thirty minutes/day, five days a week, over three months. Patients will be assessed on a battery of cognitive and functional outcomes on three occasions: a) immediately before training, b) within forty-eight hours post completion of total training, and c) after a three-month no-contact period post completion of total training, to assess the longevity of potential training effects. Discussion The strengths of this protocol are that it tests an innovative, in-home administered treatment that targets a fundamental deficit in neglect, employs highly sensitive computer

  8. Challenges in randomized controlled trials and emerging multiple sclerosis therapeutics.

    PubMed

    Huang, DeRen

    2015-12-01

    The remarkable global development of disease-modifying therapies (DMTs) specific for multiple sclerosis (MS) has significantly reduced the frequency of relapse, slowed the progression of disability, and improved the quality of life in patients with MS. With increasing numbers of approved DMTs, neurologists in North America and Europe are able to present multiple treatment options to their patients to achieve a better therapeutic outcome, and in many cases, no evidence of disease activity. MS patients have improved accessibility to various DMTs at no or minimal out-of-pocket cost. The ethical guidelines defined by the Edinburgh revision of the Declaration of Helsinki strongly discourage the use of placebo control groups in modern MS clinical trials. The use of an active comparator control group increases the number of participants in each group that is essential to achieve statistical significance, thus further increasing the difficulty of completing randomized controlled trials (RCTs) for the development of new MS therapies. There is evidence of a high prevalence of MS and a large number of patients in Asia. The belief of the existence of Asian types of MS that are distinct from Western types, and regulatory policies are among the reasons why DMTs are limited in most Asian countries. Lack of access to approved DMTs provides a good opportunity for clinical trials that are designed for the development of new MS therapies. Recently, data from RCTs have demonstrated excellent recruitment of participants and the completion of multi-nation and single-nation MS trials within this region. Recent studies using the McDonald MS diagnostic criteria carefully excluded patients with neuromyelitis optica (NMO) and NMO spectrum disorder, and demonstrated that patients with MS in Asia have clinical characteristics and treatment responses similar to those in Western countries.

  9. Repurposing historical control clinical trial data to provide safety context.

    PubMed

    Bhuyan, Prakash; Desai, Jigar; Louis, Matthew St; Carlsson, Martin; Bowen, Edward; Danielson, Mark; Cantor, Michael N

    2016-02-01

    Billions of dollars spent, millions of subject-hours of clinical trial experience and an abundance of archived study-level data, yet why are historical data underutilized? We propose that historical data can be aggregated to provide safety, background incidence rate and context to improve the evaluation of new medicinal products. Here, we describe the development and application of the eControls database, which is derived from the control arms of studies of licensed products, and discuss the challenges and potential solutions to the proper application of historical data to help interpret product safety. PMID:26523771

  10. Repurposing historical control clinical trial data to provide safety context.

    PubMed

    Bhuyan, Prakash; Desai, Jigar; Louis, Matthew St; Carlsson, Martin; Bowen, Edward; Danielson, Mark; Cantor, Michael N

    2016-02-01

    Billions of dollars spent, millions of subject-hours of clinical trial experience and an abundance of archived study-level data, yet why are historical data underutilized? We propose that historical data can be aggregated to provide safety, background incidence rate and context to improve the evaluation of new medicinal products. Here, we describe the development and application of the eControls database, which is derived from the control arms of studies of licensed products, and discuss the challenges and potential solutions to the proper application of historical data to help interpret product safety.

  11. Sexual assault resistance education for university women: study protocol for a randomized controlled trial (SARE trial)

    PubMed Central

    2013-01-01

    Background More than one in six women will be sexually assaulted in their lifetimes, most by men they know. The situation on university campuses is even more startling, with as many as 1 in 4 female students being victims of rape or attempted rape. The associated physical and mental health effects are extensive and the social and economic costs are staggering. The aim of this randomized controlled trial is to determine whether a novel, small-group sexual assault resistance education program can reduce the incidence of sexual assault among university-attending women, when compared to current university practice of providing informational brochures. Methods/Design The trial will evaluate a theoretically and empirically sound four-unit, 12-hour education program that has been demonstrated in pilot studies to have short-term efficacy. Three of the four units provide information, skills, and practice aimed at decreasing the time needed for women to assess situations with elevated risk of acquaintance sexual assault as dangerous and to take action, reducing emotional obstacles to taking action, and increasing the use of the most effective methods of verbal and physical self-defense. The fourth unit focuses on facilitating a stronger positive sexuality from which women may resist sexual coercion by male intimates more successfully. The trial will extend the pilot evaluations by expanding the participant pool and examining the long term efficacy of the program. A total of 1716 first-year female students (age 17 to 24 years) from three Canadian universities will be enrolled. The primary outcome is completed sexual assault, measured by The Sexual Experiences Survey - Short Form Victimization instrument. Secondary outcomes include changes in knowledge, attitudes, and skills related to the process of sexual assault resistance. Outcomes will be measured at baseline, 1 week, 6, 12, 18, and 24 months. Discussion The results of the trial will be used to produce a maximally

  12. Preconception maternal nutrition: a multi-site randomized controlled trial

    PubMed Central

    2014-01-01

    Background Research directed to optimizing maternal nutrition commencing prior to conception remains very limited, despite suggestive evidence of its importance in addition to ensuring an optimal nutrition environment in the periconceptional period and throughout the first trimester of pregnancy. Methods/Study design This is an individually randomized controlled trial of the impact on birth length (primary outcome) of the time at which a maternal nutrition intervention is commenced: Arm 1: ≥ 3 mo preconception vs. Arm 2: 12-14 wk gestation vs. Arm 3: none. 192 (derived from 480) randomized mothers and living offspring in each arm in each of four research sites (Guatemala, India, Pakistan, Democratic Republic of the Congo). The intervention is a daily 20 g lipid-based (118 kcal) multi-micronutient (MMN) supplement. Women randomized to receive this intervention with body mass index (BMI) <20 or whose gestational weight gain is low will receive an additional 300 kcal/d as a balanced energy-protein supplement. Researchers will visit homes biweekly to deliver intervention and monitor compliance, pregnancy status and morbidity; ensure prenatal and delivery care; and promote breast feeding. The primary outcome is birth length. Secondary outcomes include: fetal length at 12 and 34 wk; incidence of low birth weight (LBW); neonatal/infant anthropometry 0-6 mo of age; infectious disease morbidity; maternal, fetal, newborn, and infant epigenetics; maternal and infant nutritional status; maternal and infant microbiome; gut inflammatory biomarkers and bioactive and nutritive compounds in breast milk. The primary analysis will compare birth Length-for-Age Z-score (LAZ) among trial arms (independently for each site, estimated effect size: 0.35). Additional statistical analyses will examine the secondary outcomes and a pooled analysis of data from all sites. Discussion Positive results of this trial will support a paradigm shift in attention to nutrition of all females of

  13. Central coordination as an alternative for local coordination in a multicenter randomized controlled trial: the FAITH trial experience

    PubMed Central

    2012-01-01

    Background Surgeons in the Netherlands, Canada and the US participate in the FAITH trial (Fixation using Alternative Implants for the Treatment of Hip fractures). Dutch sites are managed and visited by a financed central trial coordinator, whereas most Canadian and US sites have local study coordinators and receive per patient payment. This study was aimed to assess how these different trial management strategies affected trial performance. Methods Details related to obtaining ethics approval, time to trial start-up, inclusion, and percentage completed follow-ups were collected for each trial site and compared. Pre-trial screening data were compared with actual inclusion rates. Results Median trial start-up ranged from 41 days (P25-P75 10-139) in the Netherlands to 232 days (P25-P75 98-423) in Canada (p = 0.027). The inclusion rate was highest in the Netherlands; median 1.03 patients (P25-P75 0.43-2.21) per site per month, representing 34.4% of the total eligible population. It was lowest in Canada; 0.14 inclusions (P25-P75 0.00-0.28), representing 3.9% of eligible patients (p < 0.001). The percentage completed follow-ups was 83% for Canadian and Dutch sites and 70% for US sites (p = 0.217). Conclusions In this trial, a central financed trial coordinator to manage all trial related tasks in participating sites resulted in better trial progression and a similar follow-up. It is therefore a suitable alternative for appointing these tasks to local research assistants. The central coordinator approach can enable smaller regional hospitals to participate in multicenter randomized controlled trials. Circumstances such as available budget, sample size, and geographical area should however be taken into account when choosing a management strategy. Trial Registration ClinicalTrials.gov: NCT00761813 PMID:22225733

  14. Selection of intervention components in an internet stop smoking participant preference trial: beyond randomized controlled trials.

    PubMed

    Schueller, Stephen M; Leykin, Yan; Pérez-Stable, Eliseo J; Muñoz, Ricardo F

    2013-01-30

    To address health problems that have a major impact on global health requires research designs that go beyond randomized controlled trials. One such design, the participant preference trial, provides additional information in an ecologically valid manner, once intervention efficacy has been demonstrated. The current study presents illustrative data from a participant preference trial of an internet-based smoking cessation intervention. Participants (N=7763) from 124 countries accessed the intervention and were allowed to choose from nine different site components to aid their quit attempt. Of consenting participants, 36.7% completed at least one follow-up assessment. Individuals with depression were more likely to choose a mood management module and participants who smoked a higher number of cigarettes were more likely to choose a cigarette counter and a nicotine replacement therapy guide. Furthermore, depressed participants selecting the mood management component were more likely to report at least one successful 7 day quit (37.2% vs. 22.2%) in the 12 months following the intervention. Thus, participants with depressive symptoms appear to make choices on the basis of their needs and to benefit from these decisions. This suggests that providing the ability to customize previously validated resources may be a successful way to widely disseminate interventions.

  15. Strategies for Increasing Recruitment to Randomised Controlled Trials: Systematic Review

    PubMed Central

    Caldwell, Patrina H. Y.; Hamilton, Sana; Tan, Alvin; Craig, Jonathan C.

    2010-01-01

    Background Recruitment of participants into randomised controlled trials (RCTs) is critical for successful trial conduct. Although there have been two previous systematic reviews on related topics, the results (which identified specific interventions) were inconclusive and not generalizable. The aim of our study was to evaluate the relative effectiveness of recruitment strategies for participation in RCTs. Methods and Findings A systematic review, using the PRISMA guideline for reporting of systematic reviews, that compared methods of recruiting individual study participants into an actual or mock RCT were included. We searched MEDLINE, Embase, The Cochrane Library, and reference lists of relevant studies. From over 16,000 titles or abstracts reviewed, 396 papers were retrieved and 37 studies were included, in which 18,812 of at least 59,354 people approached agreed to participate in a clinical RCT. Recruitment strategies were broadly divided into four groups: novel trial designs (eight studies), recruiter differences (eight studies), incentives (two studies), and provision of trial information (19 studies). Strategies that increased people's awareness of the health problem being studied (e.g., an interactive computer program [relative risk (RR) 1.48, 95% confidence interval (CI) 1.00–2.18], attendance at an education session [RR 1.14, 95% CI 1.01–1.28], addition of a health questionnaire [RR 1.37, 95% CI 1.14–1.66]), or a video about the health condition (RR 1.75, 95% CI 1.11–2.74), and also monetary incentives (RR1.39, 95% CI 1.13–1.64 to RR 1.53, 95% CI 1.28–1.84) improved recruitment. Increasing patients' understanding of the trial process, recruiter differences, and various methods of randomisation and consent design did not show a difference in recruitment. Consent rates were also higher for nonblinded trial design, but differential loss to follow up between groups may jeopardise the study findings. The study's main limitation was the necessity of

  16. Field trial of 1% niclosamide as a topical antipenetrant to Schistosoma mansoni cercariae.

    PubMed

    Abu-Elyazeed, R R; Podgore, J K; Mansour, N S; Kilpatrick, M E

    1993-10-01

    A randomized, double-blind, placebo-controlled field trial of a topical antipenetrant lotion, 1% niclosamide, applied daily to the upper and lower limbs of farmers occupationally exposed to Schistosoma mansoni cercarial-infested water, was conducted in the Nile Delta to assess its safety and efficacy in preventing reinfection. Farmers aged 18-40 years were treated to cure their S. mansoni infections three months prior to the onset of the trial. Subjects were randomly assigned to receive niclosamide or placebo lotion that was self-applied daily for five months. A total of 186 subjects met the inclusion criteria and completed the trial. The exposure to schistosomal-infested water occurred during routine irrigation activities from June to November 1991. Stool specimens were evaluated monthly during and for two months following the lotion application period. The subjects applying the niclosamide lotion were comparable to those applying placebo lotion in age (mean 30 years for both), total water contact (184.5 hr versus 173.8 hr), reported lotion application compliance (88% versus 92%), and reported water contact involving skin exposure other than upper and lower limbs (23% versus 27%). The schistosomal reinfection rate was lower in the niclosamide group (53.3%) compared with the placebo lotion group (71.3%), (P < 0.02). Increased protection might be obtained with total body application for shorter, less intense, water contact exposures.

  17. Surgical trial in traumatic intracerebral hemorrhage (STITCH(Trauma)): study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Intracranial hemorrhage occurs in over 60% of severe head injuries in one of three types: extradural (EDH); subdural (SDH); and intraparenchymal (TICH). Prompt surgical removal of significant SDH and EDH is established and widely accepted. However, TICH is more common and is found in more than 40% of severe head injuries. It is associated with a worse outcome but the role for surgical removal remains undefined. Surgical practice in the treatment of TICHs differs widely around the world. The aim of early surgery in TICH removal is to prevent secondary brain injury. There have been trials of surgery for spontaneous ICH (including the STICH II trial), but none so far of surgery for TICH. Methods/Design The UK National Institutes of Health Research has funded STITCH(Trauma) to determine whether a policy of early surgery in patients with TICH improves outcome compared to a policy of initial conservative treatment. It will include a health economics component and carry out a subgroup analysis of patients undergoing invasive monitoring. This is an international multicenter pragmatic randomized controlled trial. Patients are eligible if: they are within 48 h of injury; they have evidence of TICH on CT scan with a confluent volume of attenuation significantly raised above that of the background white and grey matter that has a total volume >10 mL; and their treating neurosurgeon is in equipoise. Patients will be ineligible if they have: a significant surface hematoma (EDH or SDH) requiring surgery; a hemorrhage/contusion located in the cerebellum; three or more separate hematomas fulfilling inclusion criteria; or severe pre-existing physical or mental disability or severe co-morbidity which would lead to poor outcome even if the patient made a full recovery from the head injury. Patients will be randomized via an independent service. Patients randomized to surgery receive surgery within 12 h. Both groups will be monitored according to standard neurosurgical

  18. Nicotine patch preloading for smoking cessation (the preloading trial): study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background The use of nicotine replacement therapy before quitting smoking is called nicotine preloading. Standard smoking cessation protocols suggest commencing nicotine replacement therapy only on the first day of quitting smoking (quit day) aiming to reduce withdrawal symptoms and craving. However, other, more successful smoking cessation pharmacotherapies are used prior to the quit day as well as after. Nicotine preloading could improve quit rates by reducing satisfaction from smoking prior to quitting and breaking the association between smoking and reward. A systematic literature review suggests that evidence for the effectiveness of preloading is inconclusive and further trials are needed. Methods/Design This is a study protocol for a multicenter, non-blinded, randomized controlled trial based in the United Kingdom, enrolling 1786 smokers who want to quit, funded by the National Institute for Health Research, Health Technology Assessment program, and sponsored by the University of Oxford. Participants will primarily be recruited through general practices and smoking cessation clinics, and randomized (1:1) either to use 21 mg nicotine patches, or not, for four weeks before quitting, whilst smoking as normal. All participants will be referred to receive standard smoking cessation service support. Follow-ups will take place at one week, four weeks, six months and 12 months after quit day. The primary outcome will be prolonged, biochemically verified six-month abstinence. Additional outcomes will include point prevalence abstinence and abstinence of four-week and 12-month duration, side effects, costs of treatment, and markers of potential mediators and moderators of the preloading effect. Discussion This large trial will add substantially to evidence on the effectiveness of nicotine preloading, but also on its cost effectiveness and potential mediators, which have not been investigated in detail previously. A range of recruitment strategies have been

  19. A controlled trial of community based coronary rehabilitation.

    PubMed Central

    Bethell, H J; Mullee, M A

    1990-01-01

    Two hundred patients who had suffered an acute myocardial infarction 4-6 weeks before entered a randomised controlled trial of exercise treatment at a community sports centre supervised by a general practitioner. Eighty one per cent of the treatment group continued to exercise until they returned to work and 73% completed three months' exercise. There were no serious complications of the exercise course. The prevalence of angina pectoris fell by 10% in the treatment group but rose by 60% in the control group. The perceived energy level rose by significantly more in the treatment group than in the controls. The rise in predicted maximum oxygen uptake was significantly greater in the treatment group than in the control group as was the reduction in the double product (a reflection of myocardial workload) at peak exercise. Coronary rehabilitation in the community can be both safe and effective. Images p375-a PMID:2271343

  20. A randomized controlled trial to promote volunteering in older adults.

    PubMed

    Warner, Lisa M; Wolff, Julia K; Ziegelmann, Jochen P; Wurm, Susanne

    2014-12-01

    Volunteering is presumed to confer health benefits, but interventions to encourage older adults to volunteer are sparse. Therefore, a randomized controlled trial with 280 community-dwelling older German adults was conducted to test the effects of a theory-based social-cognitive intervention against a passive waiting-list control group and an active control intervention designed to motivate physical activity. Self-reports of weekly volunteering minutes were assessed at baseline (5 weeks before the intervention) as well as 2 and 6 weeks after the intervention. Participants in the treatment group increased their weekly volunteering minutes to a greater extent than participants in the control groups 6 weeks after the intervention. We conclude that a single, face-to-face group session can increase volunteering among older community-dwelling adults. However, the effects need some time to unfold because changes in volunteering were not apparent 2 weeks after the intervention.

  1. Transgenic Field Trials for FHB Resistance and Related Research in Wheat and Barley

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Transgenic wheat and barley lines expressing genes with the potential to reduce FHB and DON have been tested in field trials in Minnesota since 1997 and in North Dakota since 2001 (barley only). Replicated trials are planted, grown, and harvested to meet containment regulations of the Animal and Pla...

  2. The HAART cell phone adherence trial (WelTel Kenya1): a randomized controlled trial protocol

    PubMed Central

    Lester, Richard T; Mills, Edward J; Kariri, Antony; Ritvo, Paul; Chung, Michael; Jack, William; Habyarimana, James; Karanja, Sarah; Barasa, Samson; Nguti, Rosemary; Estambale, Benson; Ngugi, Elizabeth; Ball, T Blake; Thabane, Lehana; Kimani, Joshua; Gelmon, Lawrence; Ackers, Marta; Plummer, Francis A

    2009-01-01

    Background The objectives are to compare the effectiveness of cell phone-supported SMS messaging to standard care on adherence, quality of life, retention, and mortality in a population receiving antiretroviral therapy (ART) in Nairobi, Kenya. Methods and Design A multi-site randomized controlled open-label trial. A central randomization centre provided opaque envelopes to allocate treatments. Patients initiating ART at three comprehensive care clinics in Kenya will be randomized to receive either a structured weekly SMS ('short message system' or text message) slogan (the intervention) or current standard of care support mechanisms alone (the control). Our hypothesis is that using a structured mobile phone protocol to keep in touch with patients will improve adherence to ART and other patient outcomes. Participants are evaluated at baseline, and then at six and twelve months after initiating ART. The care providers keep a weekly study log of all phone based communications with study participants. Primary outcomes are self-reported adherence to ART and suppression of HIV viral load at twelve months scheduled follow-up. Secondary outcomes are improvements in health, quality of life, social and economic factors, and retention on ART. Primary analysis is by 'intention-to-treat'. Sensitivity analysis will be used to assess per-protocol effects. Analysis of covariates will be undertaken to determine factors that contribute or deter from expected and determined outcomes. Discussion This study protocol tests whether a novel structured mobile phone intervention can positively contribute to ART management in a resource-limited setting. Trial Registration Trial Registration Number: NCT00830622 PMID:19772596

  3. The Ethics of Randomized Controlled Trials in Social Settings: Can Social Trials Be Scientifically Promising and Must There Be Equipoise?

    ERIC Educational Resources Information Center

    Fives, Allyn; Russell, Daniel W.; Canavan, John; Lyons, Rena; Eaton, Patricia; Devaney, Carmel; Kearns, Norean; O'Brien, Aoife

    2015-01-01

    In a randomized controlled trial (RCT), treatments are assigned randomly and treatments are withheld from participants. Is it ethically permissible to conduct an RCT in a social setting? This paper addresses two conditions for justifying RCTs: that there should be a state of equipoise and that the trial should be scientifically promising.…

  4. Controlled human malaria infection trials: How tandems of trust and control construct scientific knowledge.

    PubMed

    Bijker, Else M; Sauerwein, Robert W; Bijker, Wiebe E

    2016-02-01

    Controlled human malaria infections are clinical trials in which healthy volunteers are deliberately infected with malaria under controlled conditions. Controlled human malaria infections are complex clinical trials: many different groups and institutions are involved, and several complex technologies are required to function together. This functioning together of technologies, people, and institutions is under special pressure because of potential risks to the volunteers. In this article, the authors use controlled human malaria infections as a strategic research site to study the use of control, the role of trust, and the interactions between trust and control in the construction of scientific knowledge. The authors argue that tandems of trust and control play a central role in the successful execution of clinical trials and the construction of scientific knowledge. More specifically, two aspects of tandems of trust and control will be highlighted: tandems are sites where trust and control coproduce each other, and tandems link the personal, the technical, and the institutional domains. Understanding tandems of trust and control results in setting some agendas for both clinical trial research and science and technology studies.

  5. Optimal Control for Coupled Near-Field/Far-Field Domains

    NASA Astrophysics Data System (ADS)

    Chen, Guoquan; Collis, S. Scott; Ghayour, Kaveh; Heinkenschloss, Matthias

    2002-11-01

    A new multidomain/multiphysics computational framework for optimal control of aeroacoustic noise has been developed based on a near-field compressible Navier--Stokes solver coupled with a far-field wave equation using a discontinuous Galerkin formulation. In this approach, the coupling of near-field and far-field domains is achieved by weakly enforcing continuity of normal fluxes across a coupling surface that encloses all nonlinear flow effects and noise sources. For optimal control, gradient formation is obtained by the solution of an appropriate adjoint problem that involves the propagation of adjoint information from the far-field to the near-field. The formulation and implementation of the state and adjoint problems will be presented along with preliminary results. This computational framework will be applied in the future to study optimal boundary control of blade-vortex interaction, which is a significant noise source for helicopters on approach to landing.

  6. Pen and field trials of flupropadine against the house mouse (Mus musculus L.).

    PubMed

    Rowe, F P; Bradfield, A; Swinney, T

    1985-10-01

    Laboratory and field trials were conducted to determine the efficacy of the candidate rodenticide flupropadine against the house mouse (Mus musculus L.). In laboratory feeding tests, family groups of wild mice maintained in pens and conditioned to feeding on plain foods were offered flupropadine at either 0.10%, 0.15%, 0.18% or 0.20% in pinhead oatmeal bait. Overall mortalities in replicated 21-day treatments were 66/71 (93.0%), 71/79 (89.9%), 72/76 (94.7%) and 69/75 (92.0%) respectively. In 17 field trials carried out against mice infesting farm buildings, flupropadine was used at 0.10%, 0.15% and 0.18% in oatmeal bait. Mean treatment success, estimated from live-capture and mortality data, was 88.6%, 96.2% and 96.6% respectively. Flupropadine was found to be as near effective against mice as calciferol/warfarin and the second-generation anticoagulant rodenticides difenacoum, bromadiolone and brodifacoum. In further comparison with the anticoagulants, treatment with flupropadine bait achieved markedly quicker control. PMID:4067302

  7. Pen and field trials of flupropadine against the house mouse (Mus musculus L.).

    PubMed Central

    Rowe, F. P.; Bradfield, A.; Swinney, T.

    1985-01-01

    Laboratory and field trials were conducted to determine the efficacy of the candidate rodenticide flupropadine against the house mouse (Mus musculus L.). In laboratory feeding tests, family groups of wild mice maintained in pens and conditioned to feeding on plain foods were offered flupropadine at either 0.10%, 0.15%, 0.18% or 0.20% in pinhead oatmeal bait. Overall mortalities in replicated 21-day treatments were 66/71 (93.0%), 71/79 (89.9%), 72/76 (94.7%) and 69/75 (92.0%) respectively. In 17 field trials carried out against mice infesting farm buildings, flupropadine was used at 0.10%, 0.15% and 0.18% in oatmeal bait. Mean treatment success, estimated from live-capture and mortality data, was 88.6%, 96.2% and 96.6% respectively. Flupropadine was found to be as near effective against mice as calciferol/warfarin and the second-generation anticoagulant rodenticides difenacoum, bromadiolone and brodifacoum. In further comparison with the anticoagulants, treatment with flupropadine bait achieved markedly quicker control. PMID:4067302

  8. Bioenergy Ecosystem Land-Use Modelling and Field Flux Trial

    NASA Astrophysics Data System (ADS)

    McNamara, Niall; Bottoms, Emily; Donnison, Iain; Dondini, Marta; Farrar, Kerrie; Finch, Jon; Harris, Zoe; Ineson, Phil; Keane, Ben; Massey, Alice; McCalmont, Jon; Morison, James; Perks, Mike; Pogson, Mark; Rowe, Rebecca; Smith, Pete; Sohi, Saran; Tallis, Mat; Taylor, Gail; Yamulki, Sirwan

    2013-04-01

    Climate change impacts resulting from fossil fuel combustion and concerns about the diversity of energy supply are driving interest to find low-carbon energy alternatives. As a result bioenergy is receiving widespread scientific, political and media attention for its potential role in both supplying energy and mitigating greenhouse (GHG) emissions. It is estimated that the bioenergy contribution to EU 2020 renewable energy targets could require up to 17-21 million hectares of additional land in Europe (Don et al., 2012). There are increasing concerns that some transitions into bioenergy may not be as sustainable as first thought when GHG emissions from the crop growth and management cycle are factored into any GHG life cycle assessment (LCA). Bioenergy is complex and encapsulates a wide range of crops, varying from food crop based biofuels to dedicated second generation perennial energy crops and forestry products. The decision on the choice of crop for energy production significantly influences the GHG mitigation potential. It is recognised that GHG savings or losses are in part a function of the original land-use that has undergone change and the management intensity for the energy crop. There is therefore an urgent need to better quantify both crop and site-specific effects associated with the production of conventional and dedicated energy crops on the GHG balance. Currently, there is scarcity of GHG balance data with respect to second generation crops meaning that process based models and LCAs of GHG balances are weakly underpinned. Therefore, robust, models based on real data are urgently required. In the UK we have recently embarked on a detailed program of work to address this challenge by combining a large number of field studies with state-of-the-art process models. Through six detailed experiments, we are calculating the annual GHG balances of land use transitions into energy crops across the UK. Further, we are quantifying the total soil carbon gain or

  9. Controlled trial of oligoantigenic treatment in the hyperkinetic syndrome.

    PubMed

    Egger, J; Carter, C M; Graham, P J; Gumley, D; Soothill, J F

    1985-03-01

    76 selected overactive children were treated with an oligoantigenic diet, 62 improved, and a normal range of behaviour was achieved in 21 of these. Other symptoms, such as headaches, abdominal pain, and fits, also often improved. 28 of the children who improved completed a double-blind, crossover, placebo-controlled trial in which foods thought to provoke symptoms were reintroduced. Symptoms returned or were exacerbated much more often when patients were on active material than on placebo. 48 foods were incriminated. Artificial colorants and preservatives were the commonest provoking substances, but no child was sensitive to these alone.

  10. Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology

    PubMed Central

    Azar, Marleine; Riehm, Kira E.; McKay, Dean; Thombs, Brett D.

    2015-01-01

    Background Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals. Methods Eligible RCTs were published in JCCP in 2013–2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration. Results Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709). Conclusions The quality of published outcome analysis

  11. Simulation of nZVI Transport at a Push-Pull Field Trial

    NASA Astrophysics Data System (ADS)

    O'Carroll, D. M.; Oleniuk, A. J.; Kocur, C. M.; Sleep, B. E.; Xiong, Z.; Bennett, P.

    2010-12-01

    Nano-scale Zero Valent Iron (nZVI) is receiving significant attention due to its ability to rapidly reduce priority source zone contaminants (eg: chlorinated compounds) in controlled laboratory experiments. Although nZVI has shown significant promise in laboratory experiments the limited field studies completed to date have found that nZVI subsurface mobility is less than expected. For example, nZVI is stable in aqueous solutions for extended periods of time (eg: days) and stabilized nZVI is quite mobile in laboratory column experiments. However, field scale studies have found mobility decreases significantly in one day. To explore the causes for lower than expected mobility at the field scale a two-dimensional numerical model (Compsim) was developed to simulate the movement of nZVI observed at an actual field pilot study. Simulation results were in very good agreement with the three conservative tracer and nZVI push-pull field trials. Results suggest that subsurface heterogeneities and the viscous nature of the polymers used to stabilize nZVI decrease pore water velocity thereby limiting nZVI transport. Furthermore, nZVI aggregation in the injection vessel decreased the amount of nZVI delivered to the subsurface below what was expected. Results from this study will be used to optimize nZVI injection strategies.

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

    NASA Astrophysics Data System (ADS)

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

    2011-01-01

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

  13. Amiloride Clinical Trial In Optic Neuritis (ACTION) protocol: a randomised, double blind, placebo controlled trial

    PubMed Central

    McKee, Justin B; Elston, John; Evangelou, Nikos; Gerry, Stephen; Fugger, Lars; Kennard, Christopher; Kong, Yazhuo; Palace, Jacqueline; Craner, Matthew

    2015-01-01

    Introduction Neurodegeneration is a widely accepted contributor to the development of long-term disability in multiple sclerosis (MS). While current therapies in MS predominantly target inflammation and reduce relapse rate they have been less effective at preventing long-term disability. The identification and evaluation of effective neuroprotective therapies within a trial paradigm are key unmet needs. Emerging evidence supports amiloride, a licenced diuretic, as a neuroprotective agent in MS through acid sensing ion channel blockade. Optic neuritis (ON) is a common manifestation of MS with correlates of inflammation and neurodegeneration measurable within the visual pathways. Amiloride Clinical Trial In Optic Neuritis (ACTION) will utilise a multimodal approach to assess the neuroprotective efficacy of amiloride in acute ON. Methods and analysis 46 patients will be recruited within 28 days from onset of ON visual symptoms and randomised on a 1:1 basis to placebo or amiloride 10 mg daily. Double-blinded treatment groups will be balanced for age, sex and visual loss severity by a random-deterministic minimisation algorithm. The primary objective is to demonstrate that amiloride is neuroprotective in ON as assessed by scanning laser polarimetry of the peripapillary retinal nerve fibre layer (RNFL) thickness at 6 months in the affected eye compared to the unaffected eye at baseline. RNFL in combination with further retinal measures will also be assessed by optical coherence tomography. Secondary outcome measures on brain MRI will include cortical volume, diffusion-weighted imaging, resting state functional MRI, MR spectroscopy and magnetisation transfer ratio. In addition, high and low contrast visual acuity, visual fields, colour vision and electrophysiology will be assessed alongside quality of life measures. Ethics and dissemination Ethical approval was given by the south central Oxford B research ethics committee (REC reference: 13/SC/0022). The findings

  14. Dissipation of PAHs in saturated, dredged sediments: a field trial.

    PubMed

    Smith, K E; Schwab, A P; Banks, M K

    2008-08-01

    Sediments dredged from navigable rivers often contain elevated concentrations of recalcitrant, potentially toxic organic compounds such as polychlorinated biphenyls (PCBs) and polyaromatic hydrocarbons (PAHs). The presence of these compounds often requires that the sediments be stored in fully contained disposal facilities. A 3-year field study was conducted at the Jones Island disposal facility in Milwaukee, Wisconsin, to compare bioremediation of PAHs in contaminated dredged sediments in the absence of plants to phytoremediation with Salix nigra (black willow) (SX61), Spartina pectinata (prairie cord grass), Carex aquatalis (lake sedge), Lolium multiflorum (annual rye), and Scirpus fluviatilis (bulrush). Nine PAHs were detected initially in the sediments. Over the 3-year experiment, acenaphthene dissipation ranged from 94% to 100%, whereas anthracene, benzo[a]pyrene and indo[1,2,3-cd]pyrene generally had modest decreases in concentration (0-30% decrease). The remaining five PAHs ranged in degree of disappearance from 23% to 82%. Planted treatments did not enhance PAH dissipation relative to those without plants, but treatments with high biomass yield and high transpiration plant species had significantly less removal of PAHs than unplanted controls. Significant, negative correlations between nitrogen removal and decreases in PAH concentration suggest that competition for nutrients between plants and microorganisms may have impeded the microbial degradation of PAHs in the rhizosphere of the more rapidly growing plant species.

  15. Extrinsic stain removal with a toothpowder: A randomized controlled trial

    PubMed Central

    Khan, Muhammad Khalil; Bokhari, Syed Akhtar Hussain; Haleem, Abdul; Kareem, Abdul; Khan, Ayyaz Ali; Hosein, Tasleem; Khan, Muhammad Usama

    2014-01-01

    Objectives The efficacy of a commercially available toothpowder was compared with toothpaste in removing extrinsic dental stains. Methods In this single-blind, randomized controlled trial, 77 volunteers were included from a residential professional college. All study subjects (control toothpaste users and test toothpowder users) plaque control measures. All study subjects were instructed to rinse with 5 ml 0.12% chlorhexidine mouthwash for 1 minute, twice and one cup of double tea bag solution three times daily for three weeks. Subjects were randomized into test (n=36) and control (n=36) groups. Toothpaste (control) and toothpowder (test) was used for two weeks to see the effects on removing stains on the labial surfaces of 12 anterior teeth. For measuring dental extrinsic stains Lobene Stain Index (SI) was used. Results The amount of stain following the use of toothpaste and toothpowder was more controlled with the experimental toothpowder. For all sites combined, there was evidence that the experimental toothpowder was significantly superior to toothpaste in reducing stain area (p<.001), stain intensity (p<.001) and composite/product (area × intensity) (p<.001). Conclusion Stain removing efficacy of toothpowder was significantly higher as compared with toothpaste. A toothpowder may be expected to be of benefit in controlling and removing extrinsic dental staining. PMID:25505862

  16. Emphasized warning reduces salt intake: a randomized controlled trial.

    PubMed

    Pinjuh Markota, Nina; Rumboldt, Mirjana; Rumboldt, Zvonko

    2015-03-01

    Excessive salt intake is a major cardiovascular risk factor. At variance to the developed countries, the main source of sodium in transitional and developing countries is salt added while cooking and/or at the table. The objective of this trial was to examine the impact of warning labels placed on home salt containers on daily salt intake.A sample of treated hypertensives (n = 150) was randomized in two subgroups, one receiving just a leaflet about the harmful effects of excessive salt intake (control; n = 74), and the other one receiving in addition warning stickers for household salt containers (intervention; n = 76). Arterial blood pressure (BP) and 24-hour urinary sodium excretion (Na24) were measured in all the subjects at the start of the trial, and 1 month and 2 months later. The average starting Na24 was 207 ± 71 mmol in the control group and 211 ± 85 mmol in the intervention group (P = .745). One month and 2 months later, a significant decrease was observed in the intervention group (to 183 ± 63 mmol and 176 ± 55 mmol; P < .0001), as opposed to the control group (203 ± 60 mmol and 200 ± 58 mmol; P = .1466). Initial BP was 143.7/84.1 mm Hg in the control, and 142.9/84.7 mm Hg in the intervention group (P = .667). One month and 2 months later, a significant drop in BP, by 5.3/2.9 mm Hg, was observed in the intervention group as opposed to the control group (0.4/0.9 mm Hg). Decrease in Na24 positively correlated to BP lowering (r(2) = 0.5989; P < .0001). A significant reduction in 24Na and BP is achieved with warning labels on harmful effects of excessive salt intake. Decreasing daily salt input by 35 mmol may result in an extra BP lowering by some 5-6/2-3 mm Hg.

  17. Computer-guided concentration-controlled trials in autoimmune disorders.

    PubMed

    McMichael, J; Lieberman, R; Doyle, H; McCauley, J; van Thiel, D; Thomson, A; Fung, J; Starzl, T E

    1993-12-01

    A randomized concentration-controlled clinical trial (RCCCT) is an alternate experimental design to the standard dose-controlled study. In a RCCCT, patients are randomly assigned to predefined plasma or blood drug concentration ranges (low, medium, and high). With the caveat that concentration ranges are sufficiently separated, this design should enhance the ability to discover important concentration response relationships. FK-506, a potent and promising immunosuppressive agent for prevention and treatment of graft rejection, has shown significant clinical activity in some immune-mediated disorders. To implement the RCCCT design, a novel FK-506 intelligent dosing system (IDS) was used to guide all doses to prospectively achieve the target concentration range specific in the study protocol. Patients enrolled in these trials suffered from a variety of autoimmune disorders, including multiple sclerosis, primary biliary cirrhosis, psoriasis, autoimmune chronic active hepatitis, and nephrotic syndrome. We observed excellent predictive performance of the IDS for all patients. The accuracy (mean prediction error) of the IDS was -0.022 ng/ml and the precision (standard deviation of the prediction error) was 0.119 ng/ml. Thus, the IDS is both accurate and reproducible for autoimmune patients. We conclude that the RCCCT design, guided by an accurate and precise IDS, is an informative and cost-effective approach for evaluation of efficacy and safety of effective but highly toxic agents.

  18. Psychological rehabilitation after myocardial infarction: multicentre randomised controlled trial.

    PubMed Central

    Jones, D. A.; West, R. R.

    1996-01-01

    OBJECTIVE: To evaluate rehabilitation after myocardial infarction. DESIGN: Randomised controlled trial of rehabilitation in unselected myocardial infarction patients in six centres, baseline data being collected on admission and by structured interview (of patients and spouses) shortly after discharge and outcome being assessed by structured interview at six months and clinical examination at 12 months. SETTING: Six district general hospitals. SUBJECTS: All 2328 eligible patients admitted over two years with confirmed myocardial infarction and discharged home within 28 days. INTERVENTIONS: Rehabilitation programmes comprising psychological therapy, counselling, relaxation training, and stress management training over seven weekly group outpatient sessions for patients and spouses. MAIN OUTCOME MEASURES: Anxiety, depression, quality of life, morbidity, use of medication, and mortality. RESULTS: At six months there were no significant differences between rehabilitation patients and controls in reported anxiety (prevalence 33%) or depression (19%). Rehabilitation patients reported a lower frequency of angina (median three versus four episodes a week), medication, and physical activity. At 12 months there were no differences in clinical complications, clinical sequelae, or mortality. CONCLUSIONS: Rehabilitation programmes based on psychological therapy, counselling, relaxation training, and stress management seem to offer little objective benefit to patients who have experienced myocardial infarction compared with previous reports of smaller trials. PMID:8978226

  19. HealthLinks randomized controlled trial: Design and baseline results.

    PubMed

    Hannon, Peggy A; Hammerback, Kristen; Allen, Claire L; Parrish, Amanda T; Chan, K Gary; Kohn, Marlana J; Teague, Sara; Beresford, Shirley A A; Helfrich, Christian D; Harris, Jeffrey R

    2016-05-01

    Small employers, especially those in low-wage industries, frequently lack the capacity and resources to implement evidence-based health promotion interventions without support and assistance. The purpose of this paper is to (a) describe the intervention design and study protocol of the HealthLinks Trial and (b) report baseline findings. This study is a three-arm randomized controlled trial testing the impact of the HealthLinks intervention on worksites' adoption and implementation of evidence-based interventions. Group 1 will receive HealthLinks, Group 2 will receive HealthLinks plus wellness committees, and Group 3 will be a delayed control group. Seventy-eight employers are participating in the study; and 3302 employees across the worksites participated in the baseline data collection. Employers and employees will participate in follow-up surveys at one and two years after baseline to measure implementation (one year) and maintenance (two years) of HealthLinks interventions. Study outcomes will determine whether HealthLinks is an effective approach to increasing evidence-based health promotion in small, low-wage worksites and whether wellness committees are a capacity-building tool that increases HealthLinks' effectiveness. PMID:26946121

  20. Validation of Placebo in a Manual Therapy Randomized Controlled Trial

    PubMed Central

    Chaibi, Aleksander; Šaltytė Benth, Jūratė; Bjørn Russell, Michael

    2015-01-01

    At present, no consensus exists among clinical and academic experts regarding an appropriate placebo for randomized controlled trials (RCTs) of spinal manipulative therapy (SMT). Therefore, we investigated whether it was possible to conduct a chiropractic manual-therapy RCT with placebo. Seventy migraineurs were randomized to a single-blinded placebo-controlled clinical trial that consisted of 12 treatment sessions over 3 months. The participants were randomized to chiropractic SMT or placebo (sham manipulation). After each session, the participants were surveyed on whether they thought they had undergone active treatment (“yes” or “no”) and how strongly they believed that active treatment was received (numeric rating scale 0–10). The outcome measures included the rate of successful blinding and the certitude of the participants’ beliefs in both treatment groups. At each treatment session, more than 80% of the participants believed that they had undergone active treatment, regardless of group allocation. The odds ratio for believing that active treatment was received was >10 for all treatment sessions in both groups (all p < 0.001). The blinding was maintained throughout the RCT. Our results strongly demonstrate that it is possible to conduct a single-blinded manual-therapy RCT with placebo and to maintain the blinding throughout 12 treatment sessions given over 3 months. PMID:26145718

  1. Neonatal ECMO Study of Temperature (NEST) - a randomised controlled trial

    PubMed Central

    2010-01-01

    Background Existing evidence indicates that once mature neonates with severe cardio-respiratory failure become eligible for Extra Corporeal Membrane Oxygenation (ECMO) their chances of intact survival are doubled if they actually receive ECMO. However, significant numbers survive with disability. NEST is a multi-centre randomised controlled trial designed to test whether, in neonates requiring ECMO, cooling to 34°C for the first 48 to 72 hours of their ECMO course leads to improved later health status. Infants allocated to the control group will receive ECMO at 37°C throughout their course, which is currently standard practice around the world. Health status of both groups will be assessed formally at 2 years corrected age. Methods/Design All infants recruited to the study will be cared for in one of the four United Kingdom (UK) ECMO centres. Babies who are thought to be eligible will be assessed by the treating clinician who will confirm eligibility, ensure that consent has been obtained and then randomise the baby using a web based system, based at the National Perinatal Epidemiology Unit (NPEU) Clinical Trials Unit. Trial registration. Babies allocated ECMO without cooling will receive ECMO at 37°C ± 0.2°C. Babies allocated ECMO with cooling will be managed at 34°C ± 0.2°C for up to 72 hours from the start of their ECMO run. The minimum duration of cooling will be 48 hours. Rewarming (to 37°C) will occur at a rate of no more than 0.5°C per hour. All other aspects of ECMO management will be identical. Primary outcome: Cognitive score from the Bayley Scales of Infant and Toddler Development, 3rd edition (Bayley-III) at age of 2 years (24 - 27 months). Discussion For the primary analysis, children will be analysed in the groups to which they are assigned, comparing the outcome of all babies allocated to "ECMO with cooling" with all those allocated to "ECMO" alone, regardless of deviation from the protocol or treatment received. For the primary outcome the

  2. A reinvestigation of recruitment to randomised, controlled, multicenter trials: a review of trials funded by two UK funding agencies

    PubMed Central

    2013-01-01

    Background Randomised controlled trials (RCTs) are the gold standard assessment for health technologies. A key aspect of the design of any clinical trial is the target sample size. However, many publicly-funded trials fail to reach their target sample size. This study seeks to assess the current state of recruitment success and grant extensions in trials funded by the Health Technology Assessment (HTA) program and the UK Medical Research Council (MRC). Methods Data were gathered from two sources: the National Institute for Health Research (NIHR) HTA Journal Archive and the MRC subset of the International Standard Randomised Controlled Trial Number (ISRCTN) register. A total of 440 trials recruiting between 2002 and 2008 were assessed for eligibility, of which 73 met the inclusion criteria. Where data were unavailable from the reports, members of the trial team were contacted to ensure completeness. Results Over half (55%) of trials recruited their originally specified target sample size, with over three-quarters (78%) recruiting 80% of their target. There was no evidence of this improving over the time of the assessment. Nearly half (45%) of trials received an extension of some kind. Those that did were no more likely to successfully recruit. Trials with 80% power were less likely to successfully recruit compared to studies with 90% power. Conclusions While recruitment appears to have improved since 1994 to 2002, publicly-funded trials in the UK still struggle to recruit to their target sample size, and both time and financial extensions are often requested. Strategies to cope with such problems should be more widely applied. It is recommended that where possible studies are planned with 90% power. PMID:23758961

  3. Stepping down inhaled corticosteroids in asthma: randomised controlled trial

    PubMed Central

    Hawkins, Gillian; McMahon, Alex D; Twaddle, Sara; Wood, Stuart F; Ford, Ian; Thomson, Neil C

    2003-01-01

    Objectives To determine whether the dose of inhaled corticosteroids can be stepped down in patients with chronic stable asthma while maintaining control. Design One year, randomised controlled, double blind, parallel group trial. Setting General practices throughout western and central Scotland. Participants 259 adult patients with asthma receiving regular treatment with inhaled corticosteroids at high dose (mean dose 1430 μg beclomethasone dipropionate). Interventions Participants were allocated to receive either no alteration to their dose of inhaled corticosteroid (control) or a 50% reduction in their dose if they met criteria for stable asthma (stepdown). Main outcome measures Comparison of asthma exacerbation rates, asthma related visits to general practice and hospital, health status measures, and corticosteroid dosage between the two groups. Results The proportions of subjects with asthma exacerbations were not significantly different (stepdown 31%, control 26%, P=0.354). Similarly, the numbers of visits to general practice or hospital and the disease specific and generic measures of health status over the one year period were not significantly different. On average the stepdown group received 348 μg (95% confidence interval 202 μgto494 μg) of beclomethasone dipropionate less per day than the controls (a difference of 25%), with no difference in the annual dose of oral corticosteroids between the two treatment regimens. Conclusions By adopting a stepdown approach to the use of inhaled steroids at high doses in asthma a reduction in the dose can be achieved without compromising asthma control. PMID:12763981

  4. Ethical considerations in placebo-controlled randomised clinical trials

    PubMed Central

    2015-01-01

    Summary Ethical considerations in standard medical care and clinical research are underpinnings to quality medicine. Similarly, the placebo-controlled double-blind randomised clinical trial is the gold standard for medical research and fundamental to the development of evidence-based medicine. Researchers and clinicians are challenged by ethical concerns in the informed consent with a need to maximise understanding and minimise therapeutic misconception. This editorial expands on themes raised by Chen et al’s article ‘Disclosing the Potential Impact of Placebo Controls in Antidepressant Trials’ and serves as an invitation for further submissions to BJPsych Open on ethics, research design and informed consent. Declaration of interest None. Copyright and usage © The Royal College of Psychiatrists 2015. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) licence.

  5. Testing the activitystat hypothesis: a randomised controlled trial protocol

    PubMed Central

    2012-01-01

    Background The activitystat hypothesis proposes that when physical activity or energy expenditure is increased or decreased in one domain, there will be a compensatory change in another domain to maintain an overall, stable level of physical activity or energy expenditure. To date, there has been no experimental study primarily designed to test the activitystat hypothesis in adults. The aim of this trial is to determine the effect of two different imposed exercise loads on total daily energy expenditure and physical activity levels. Methods This study will be a randomised, multi-arm, parallel controlled trial. Insufficiently active adults (as determined by the Active Australia survey) aged 18–60 years old will be recruited for this study (n=146). Participants must also satisfy the Sports Medicine Australia Pre-Exercise Screening System and must weigh less than 150 kg. Participants will be randomly assigned to one of three groups using a computer-generated allocation sequence. Participants in the Moderate exercise group will receive an additional 150 minutes of moderate to vigorous physical activity per week for six weeks, and those in the Extensive exercise group will receive an additional 300 minutes of moderate to vigorous physical activity per week for six weeks. Exercise targets will be accumulated through both group and individual exercise sessions monitored by heart rate telemetry. Control participants will not be given any instructions regarding lifestyle. The primary outcome measures are activity energy expenditure (doubly labeled water) and physical activity (accelerometry). Secondary measures will include resting metabolic rate via indirect calorimetry, use of time, maximal oxygen consumption and several anthropometric and physiological measures. Outcome measures will be conducted at baseline (zero weeks), mid- and end-intervention (three and six weeks) with three (12 weeks) and six month (24 week) follow-up. All assessors will be blinded to group

  6. A randomized controlled trial of group Stepping Stones Triple P: a mixed-disability trial.

    PubMed

    Roux, Gemma; Sofronoff, Kate; Sanders, Matthew

    2013-09-01

    Stepping Stones Triple P (SSTP) is a parenting program designed for families of a child with a disability. The current study involved a randomized controlled trial of Group Stepping Stones Triple P (GSSTP) for a mixed-disability group. Participants were 52 families of children diagnosed with an Autism Spectrum Disorder, Down syndrome, Cerebral Palsy, or an intellectual disability. The results demonstrated significant improvements in parent-reported child behavior, parenting styles, parental satisfaction, and conflict about parenting. Results among participants were similar despite children's differing impairments. The intervention effect was maintained at 6-month follow-up. The results indicate that GSSTP is a promising intervention for a mixed-disability group. Limitations of the study, along with areas for future research, are also discussed.

  7. A randomized controlled trial of group Stepping Stones Triple P: a mixed-disability trial.

    PubMed

    Roux, Gemma; Sofronoff, Kate; Sanders, Matthew

    2013-09-01

    Stepping Stones Triple P (SSTP) is a parenting program designed for families of a child with a disability. The current study involved a randomized controlled trial of Group Stepping Stones Triple P (GSSTP) for a mixed-disability group. Participants were 52 families of children diagnosed with an Autism Spectrum Disorder, Down syndrome, Cerebral Palsy, or an intellectual disability. The results demonstrated significant improvements in parent-reported child behavior, parenting styles, parental satisfaction, and conflict about parenting. Results among participants were similar despite children's differing impairments. The intervention effect was maintained at 6-month follow-up. The results indicate that GSSTP is a promising intervention for a mixed-disability group. Limitations of the study, along with areas for future research, are also discussed. PMID:24033239

  8. Exercise and manual physiotherapy arthritis research trial (EMPART): a multicentre randomised controlled trial

    PubMed Central

    French, Helen P; Cusack, Tara; Brennan, Aisling; White, Breon; Gilsenan, Clare; Fitzpatrick, Martina; O'Connell, Paul; Kane, David; FitzGerald, Oliver; McCarthy, Geraldine M

    2009-01-01

    Background Osteoarthritis (OA) of the hip is a major cause of functional disability and reduced quality of life. Management options aim to reduce pain and improve or maintain physical functioning. Current evidence indicates that therapeutic exercise has a beneficial but short-term effect on pain and disability, with poor long-term benefit. The optimal content, duration and type of exercise are yet to be ascertained. There has been little scientific investigation into the effectiveness of manual therapy in hip OA. Only one randomized controlled trial (RCT) found greater improvements in patient-perceived improvement and physical function with manual therapy, compared to exercise therapy. Methods and design An assessor-blind multicentre RCT will be undertaken to compare the effect of a combination of manual therapy and exercise therapy, exercise therapy only, and a waiting-list control on physical function in hip OA. One hundred and fifty people with a diagnosis of hip OA will be recruited and randomly allocated to one of 3 groups: exercise therapy, exercise therapy with manual therapy and a waiting-list control. Subjects in the intervention groups will attend physiotherapy for 6–8 sessions over 8 weeks. Those in the control group will remain on the waiting list until after this time and will then be re-randomised to one of the two intervention groups. Outcome measures will include physical function (WOMAC), pain severity (numerical rating scale), patient perceived change (7-point Likert scale), quality of life (SF-36), mood (hospital anxiety and depression scale), patient satisfaction, physical activity (IPAQ) and physical measures of range of motion, 50-foot walk and repeated sit-to stand tests. Discussion This RCT will compare the effectiveness of the addition of manual therapy to exercise therapy to exercise therapy only and a waiting-list control in hip OA. A high quality methodology will be used in keeping with CONSORT guidelines. The results will contribute

  9. PACE - The first placebo controlled trial of paracetamol for acute low back pain: design of a randomised controlled trial

    PubMed Central

    2010-01-01

    Background Clinical practice guidelines recommend that the initial treatment of acute low back pain (LBP) should consist of advice to stay active and regular simple analgesics such as paracetamol 4 g daily. Despite this recommendation in all international LBP guidelines there are no placebo controlled trials assessing the efficacy of paracetamol for LBP at any dose or dose regimen. This study aims to determine whether 4 g of paracetamol daily (in divided doses) results in a more rapid recovery from acute LBP than placebo. A secondary aim is to determine if ingesting paracetamol in a time-contingent manner is more effective than paracetamol taken when required (PRN) for recovery from acute LBP. Methods/Design The study is a randomised double dummy placebo controlled trial. 1650 care seeking people with significant acute LBP will be recruited. All participants will receive advice to stay active and will be randomised to 1 of 3 treatment groups: time-contingent paracetamol dose regimen (plus placebo PRN paracetamol), PRN paracetamol (plus placebo time-contingent paracetamol) or a double placebo study arm. The primary outcome will be time (days) to recovery from pain recorded in a daily pain diary. Other outcomes will be pain intensity, disability, function, global perceived effect and sleep quality, captured at baseline and at weeks 1, 2, 4 and 12 by an assessor blind to treatment allocation. An economic analysis will be conducted to determine the cost-effectiveness of treatment from the health sector and societal perspectives. Discussion The successful completion of the trial will provide the first high quality evidence on the effectiveness of the use of paracetamol, a guideline endorsed treatment for acute LBP. Trail registration ACTRN12609000966291. PMID:20650012

  10. [Phytoremediation of polychlorinated biphenyls contaminated soil by leguminosae-gramineae intercropping: a field trial].

    PubMed

    Tu, Chen; Teng, Ying; Luo, Yong-Ming; Pan, Cheng; Sun, Xiang-Hui; Li, Zhen-Gao

    2010-12-01

    Phytoremediation of polychlorinated biphenyls (PCBs) contaminated soil by leguminosae (alfalfa) and gramineae (ryegrass and tall fescue) was studied in a field trial. All planted treatments had significantly higher PCBs removal efficiency compared with those of unplanted control after 270 days of in-situ phytoremediation. Alfalfa monoculture received the highest removal efficiency of soil PCBs by 59.6%. Analysis of PCBs congeners composition showed that the percentage of di-chlorinated biphenyl decreased in all planted treatments. Alfalfa produced the maximum biomass among the 3 plants. Total PCBs concentration in alfalfa roots reached 355.1 microg/kg, which was significantly higher than those in ryegrass and tall fescue. The phytoextraction efficiency of different treatment was in order of alfalfa > alfalfa-ryegrass-tall fescue > alfalfa-ryegrass > ryegrass > alfalfa-tall fescue > tall fescue. The results suggest that alfalfa may be an ideal candidate for the phytoremediation of PCBs contaminated soil. PMID:21360900

  11. Analysis of airborne multi-spectral imagery of an oil spill field trial

    SciTech Connect

    Kalnins, V.J.; Freemantle, J.R.; Brown, C.E.

    1996-12-31

    A field trial was conducted at Canadian Forces Base Petawawa in May 1993 by the Emergencies Science Division of Environment Canada to test the effectiveness of remote sensing systems to detect oil spills. Shallow test pools covered with various thicknesses and types of oil were overflown by a number of sensors. Imagery from one of the sensors used, the Multi-element Electro-optical Imaging Scanner (MEIS), has recently been transcribed from high density digital tape and analyzed. The MEIS sensor was flown on a Falcon 20 jet and collected data at 7 different wavelengths from 518 nm to 873 nm. Preliminary results show that one of the slicks, Hydraulic Fluid, can be readily identified by its distinctive color in the visible region. The oil slicks, at least under these very controlled conditions, presented unique spectral signatures which could be identified using normal image processing classification techniques.

  12. Lyapunov Control of Quantum Systems with Impulsive Control Fields

    PubMed Central

    Yang, Wei; Sun, Jitao

    2013-01-01

    We investigate the Lyapunov control of finite-dimensional quantum systems with impulsive control fields, where the studied quantum systems are governed by the Schrödinger equation. By three different Lyapunov functions and the invariant principle of impulsive systems, we study the convergence of quantum systems with impulsive control fields and propose new results for the mentioned quantum systems in the form of sufficient conditions. Two numerical simulations are presented to illustrate the effectiveness of the proposed control method. PMID:23766712

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

    EPA Science Inventory

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

  14. Streptokinase in Recent Myocardial Infarction: A Controlled Multicentre Trial

    PubMed Central

    1971-01-01

    In this controlled multicentre trial treatment with either streptokinase or heparin was allocated at random to patients suffering from myocardial infarction of less than 24 hours' duration. Treatment with either drug was standardized and lasted for 24 hours. A total of 764 patients entered the trial; 34 patient charts were rejected (including all 28 charts from one centre) because of data failure. On retrospective analysis of the 730 remaining patients the two groups were found to have been comparable at the start. The total hospital mortality was 18·5% of 373 patients allotted to streptokinase treatment and 26·3% of 357 given herapin. The mortality after infusion (24 hours) was 10·6% of 340 patients treated with streptokinase and 17·8% of 320 given herapin (P=0·011). Reinfarction in hospital after the 24-hour period of infusion occurred significantly less often in patients treated with streptokinase (P=0·036). Bleeding from puncture sites and pyrexia occurred more frequently during streptokinase treatment. After exclusion of those patients whose diagnosis was unconfirmed on retrospective assessment, the total hospital mortality rate was 19·0% of 357 patients treated with streptokinase and 27·4% of 339 treated with heparin (P=0·011). These results indicate that in recent myocardial infarction streptokinase was superior to heparin in reducing mortality and reinfarction rate during an average period of six weeks in hospital. PMID:4934187

  15. Paradigm War Revived? On the Diagnosis of Resistance to Randomized Controlled Trials and Systematic Review in Education

    ERIC Educational Resources Information Center

    Hammersley, Martyn

    2008-01-01

    There has been considerable discussion in recent years about the role in educational research of randomized controlled trials (RCTs) and systematic reviews (SR). Advocacy of these methods arose partly as a result of the spread of the notion of evidence-based practice from medicine into other fields, and of the rise of the "new public management"…

  16. The Effectiveness of Propolis on Gingivitis: A Randomized Controlled Trial

    PubMed Central

    Paulino, Niraldo; Nör, Jacques E.; Moreira, Alexandre

    2014-01-01

    Abstract Background: A randomized, double-blind, controlled clinical trial was conducted to evaluate the effectiveness of a propolis rinse on induced gingivitis by using the co-twin study design. Methods: Twenty-one twin pairs (n=42) were enrolled in a gingivitis study with oral hygiene promotion (14 days) and gingivitis induction (21 days). During the gingivitis induction phase, one member of the twin pair was randomly assigned to a 2% typified propolis rinse, and the other was assigned a color-matched 0.05% sodium fluoride plus 0.05% cetylpyridinium chloride rinse (positive control). Patients rinsed twice daily with 20 mL for 30 seconds for 21 days. Gingivitis was measured on days −14 (baseline), 0 (after hygiene phase), and 21 (after no-hygiene phase) by using the Papillary Bleeding Score (PBS) and by standard digital imaging of the gum tissues (G-parameter). Results: The 38 persons who completed the study (age 13–22 years) were well balanced according to PBS at baseline and G-parameter after the initial hygiene phase. After 21 days without oral hygiene, the propolis rinse and positive control rinse groups did not differ significantly for average PBS measurements or G-parameter. Conclusions: Use of a 2% typified propolis rinse was equivalent to a positive control rinse during a 21-day no-hygiene period. PMID:25380344

  17. The chronic kidney disease Water Intake Trial (WIT): results from the pilot randomised controlled trial

    PubMed Central

    Clark, William F; Sontrop, Jessica M; Huang, Shih-Han; Gallo, Kerri; Moist, Louise; House, Andrew A; Weir, Matthew A; Garg, Amit X

    2013-01-01

    Background and objectives Increased water intake may benefit kidney function. Prior to initiating a larger randomised controlled trial (RCT), we examined the safety and feasibility of asking adults with chronic kidney disease (CKD) to increase their water intake. Design, setting, participants and measurements Beginning in October 2012, we randomly assigned 29 adults with stage 3 CKD (estimated glomerular filtration rate (eGFR) 30–60 mL/min/1.73 m2 and albuminuria) to one of the two groups of water intake: hydration (n=18) or standard (n=11). We asked the hydration group to increase their water intake by 1.0–1.5 L/day (in addition to usual intake, depending on sex and weight) for 6 weeks, while the control group carried on with their usual intake. Participants collected a 24 h urine sample at baseline and at 2 and 6 weeks after randomisation. Our primary outcome was the between-group difference in change in 24 h urine volume from baseline to 6 weeks. Results (63%)of participants were men, 81% were Caucasians and the average age was 61 years (SD 14 years). The average baseline eGFR was 40 mL/min/1.73 m2 (SD 11 mL/min/1.73 m2); the median albumin to creatinine ratio was 19 mg/mmol (IQR 6–74 mg/mmol). Between baseline and 6-week follow-up, the hydration group's average 24 h urine volume increased by 0.7 L/day (from 2.3 to 3.0 L/day) and the control group's 24 h urine decreased by 0.3 L/day (from 2.0 to 1.7 L/day; between-group difference in change: 0.9 L/day (95% CI 0.4 to 1.5; p=0.002)). We found no significant changes in urine, serum osmolality or electrolyte concentrations, or eGFR. No serious adverse events or changes in quality of life were reported. Conclusions A pilot RCT indicates adults with stage 3 CKD can successfully and safely increase water intake by up to 0.7 L/day in addition to usual fluid intake. Trial registration Registered with Clinical Trials—government identifier NCT01753466. PMID:24362012

  18. Challenges in measuring medication adherence: experiences from a controlled trial.

    PubMed

    Stewart, Kay; Mc Namara, Kevin P; George, Johnson

    2014-02-01

    Measurement of adherence is complex and many methods, both direct and indirect are used; there is no universal gold standard. In this article, we share our experiences in a randomised controlled study, the Hypertension Adherence Program in Pharmacy trial, evaluating a community pharmacy-based intervention for improving adherence to antihypertensive medication. Several objective and subjective measures of adherence (Morisky score, TABS score, MedsIndex, Medicines Possession Ratio) were used, but produced varying results, limiting confidence in the conclusions that could be drawn. Despite using a specifically designed data mining software program to identify potentially nonadherent patients from dispensing records, many participants were found to be adherent by the self reported Morisky scale. A lesson to be learned when targeting people for interventions to improve adherence is that information from dispensing records should be supplemented by other methods in order to identify patients most in need of assistance.

  19. Randomized controlled trials in environmental health research: ethical issues.

    PubMed

    Resnik, David B

    2008-01-01

    Randomized controlled trials (RCTs) are becoming increasingly common in environmental health research. Like all studies involving human subjects, environmental health RCTs raise many ethical challenges, ranging from obtaining informed consent to minimizing risks to protecting privacy and confidentiality. One of the most important issues raised by these studies is whether it is ethical to withhold effective environmental health interventions from research subjects in order to satisfy scientific objectives. Although environmental health investigators usually do not have professional obligations to provide medical care to research subjects, they have ethical obligations to avoid exploiting them. Withholding interventions from research subjects can be ethical, provided that it does not lead to exploitation of individuals or groups. To avoid exploiting individuals or groups, investigators should ensure that research subjects and study populations receive a fair share of the benefits of research.

  20. [Critical of the additive model of the randomized controlled trial].

    PubMed

    Boussageon, Rémy; Gueyffier, François; Bejan-Angoulvant, Theodora; Felden-Dominiak, Géraldine

    2008-01-01

    Randomized, double-blind, placebo-controlled clinical trials are currently the best way to demonstrate the clinical effectiveness of drugs. Its methodology relies on the method of difference (John Stuart Mill), through which the observed difference between two groups (drug vs placebo) can be attributed to the pharmacological effect of the drug being tested. However, this additive model can be questioned in the event of statistical interactions between the pharmacological and the placebo effects. Evidence in different domains has shown that the placebo effect can influence the effect of the active principle. This article evaluates the methodological, clinical and epistemological consequences of this phenomenon. Topics treated include extrapolating results, accounting for heterogeneous results, demonstrating the existence of several factors in the placebo effect, the necessity to take these factors into account for given symptoms or pathologies, as well as the problem of the "specific" effect.

  1. Field-measured drag area is a key correlate of level cycling time trial performance.

    PubMed

    Peterman, James E; Lim, Allen C; Ignatz, Ryan I; Edwards, Andrew G; Byrnes, William C

    2015-01-01

    Drag area (Ad ) is a primary factor determining aerodynamic resistance during level cycling and is therefore a key determinant of level time trial performance. However, Ad has traditionally been difficult to measure. Our purpose was to determine the value of adding field-measured Ad as a correlate of level cycling time trial performance. In the field, 19 male cyclists performed a level (22.1 km) time trial. Separately, field-determined Ad and rolling resistance were calculated for subjects along with projected frontal area assessed directly (AP ) and indirectly (Est AP ). Also, a graded exercise test was performed to determine [Formula: see text] peak, lactate threshold (LT), and economy. [Formula: see text] peak ([Formula: see text]) and power at LT were significantly correlated to power measured during the time trial (r = 0.83 and 0.69, respectively) but were not significantly correlated to performance time (r = - 0.42 and -0.45). The correlation with performance time improved significantly (p < 0.05) when these variables were normalized to Ad . Of note, Ad alone was better correlated to performance time (r = 0.85, p < 0.001) than any combination of non-normalized physiological measure. The best correlate with performance time was field-measured power output during the time trial normalized to Ad (r = - 0.92). AP only accounted for 54% of the variability in Ad . Accordingly, the correlation to performance time was significantly lower using power normalized to AP (r = - 0.75) or Est AP (r = - 0.71). In conclusion, unless normalized to Ad , level time trial performance in the field was not highly correlated to common laboratory measures. Furthermore, our field-measured Ad is easy to determine and was the single best predictor of level time trial performance.

  2. Mixing Methods in Randomized Controlled Trials (RCTs): Validation, Contextualization, Triangulation, and Control

    ERIC Educational Resources Information Center

    Spillane, James P.; Pareja, Amber Stitziel; Dorner, Lisa; Barnes, Carol; May, Henry; Huff, Jason; Camburn, Eric

    2010-01-01

    In this paper we described how we mixed research approaches in a Randomized Control Trial (RCT) of a school principal professional development program. Using examples from our study we illustrate how combining qualitative and quantitative data can address some key challenges from validating instruments and measures of mediator variables to…

  3. A Randomized Controlled Trial of Mindfulness Meditation for Chronic Insomnia

    PubMed Central

    Ong, Jason C.; Manber, Rachel; Segal, Zindel; Xia, Yinglin; Shapiro, Shauna; Wyatt, James K.

    2014-01-01

    Study Objectives: To evaluate the efficacy of mindfulness meditation for the treatment of chronic insomnia. Design: Three-arm, single-site, randomized controlled trial. Setting: Academic medical center. Participants: Fifty-four adults with chronic insomnia. Interventions: Participants were randomized to either mindfulness-based stress reduction (MBSR), mindfulness-based therapy for insomnia (MBTI), or an eight-week self-monitoring (SM) condition. Measurements and Results: Patient-reported outcome measures were total wake time (TWT) from sleep diaries, the pre-sleep arousal scale (PSAS), measuring a prominent waking correlate of insomnia, and the Insomnia Severity Index (ISI) to determine remission and response as clinical endpoints. Objective sleep measures were derived from laboratory polysomnography and wrist actigraphy. Linear mixed models showed that those receiving a meditation-based intervention (MBSR or MBTI) had significantly greater reductions on TWT minutes (43.75 vs 1.09), PSAS (7.13 vs 0.16), and ISI (4.56 vs 0.06) from baseline-to-post compared to SM. Post hoc analyses revealed that each intervention was superior to SM on each of the patient-reported measures, but no significant differences were found when comparing MBSR to MBTI from baseline-to-post. From baseline to 6-month follow-up, MBTI had greater reductions in ISI scores than MBSR (P < 0.05), with the largest difference occurring at the 3-month follow-up. Remission and response rates in MBTI and MBSR were sustained from post-treatment through follow-up, with MBTI showing the highest rates of treatment remission (50%) and response (78.6%) at the 6-month follow-up. Conclusions: Mindfulness meditation appears to be a viable treatment option for adults with chronic insomnia and could provide an alternative to traditional treatments for insomnia. Trial Registration: Mindfulness-Based Approaches to Insomnia: clinicaltrials.gov, identifier: NCT00768781 Citation: Ong JC, Manber R, Segal Z, Xia Y

  4. Criteria for Identifying and Evaluating Candidate Sites for Open-Field Trials of Genetically Engineered Mosquitoes

    PubMed Central

    Brown, David M.; Alphey, Luke S.; McKemey, Andrew; Beech, Camilla

    2014-01-01

    Abstract Recent laboratory successes in the development of genetically engineered mosquitoes for controlling pathogen transmission have fostered the need for standardized procedures for advancing the technical achievements to practical tools. It is incumbent in many cases for the same scientists doing the in-laboratory discovery research to also take on the initial challenges of developing the pathway that will move the technologies to the field. One of these challenges is having a set of criteria for selecting collaborators and sites for efficacy and safety field trials that combine rigorous science with good ethical and legal practices. Specific site-selection criteria were developed in four categories—Scientific, Regulatory, Community Engagement, and Resources—in anticipation of open-field releases of a transgenic mosquito strain designed to suppress populations of the dengue vector mosquito, Aedes aegypti. The criteria are derived from previous published material, discussions, and personal experiences with the expectation of providing guidance to laboratory scientists for addressing the conceptual and operational considerations for identifying partner researchers and countries with whom to collaborate. These criteria are not intended to be prescriptive nor can they be applied to every circumstance where genetic approaches are proposed for deployment. However, we encourage those involved in the discovery phase of research to consider each criterion during project planning activities, and where appropriate, incorporate them into a “go/no-go” decision-making process for further development and testing of the technologies. PMID:24689963

  5. Exercise Training and Weight Gain in Obese Pregnant Women: A Randomized Controlled Trial (ETIP Trial)

    PubMed Central

    Garnæs, Kirsti Krohn; Mørkved, Siv; Salvesen, Øyvind; Moholdt, Trine

    2016-01-01

    of 0.1 (95% CI 0.02, 0.95; p = 0.04). Systolic blood pressure was significantly lower in the exercise group (mean 120.4 mm Hg) compared to the control group (mean 128.1 mm Hg), with a mean difference of −7.73 mm Hg (95% CI −13.23, −2.22; p = 0.006). No significant between-group differences were seen in diastolic blood pressure, blood measurements, skinfold thickness, or body composition in late pregnancy. In per protocol analyses, late pregnancy systolic blood pressure was 115.7 (95% CI 110.0, 121.5) mm Hg in the exercise group (significant between-group difference, p = 0.001), and diastolic blood pressure was 75.1 (95% CI 71.6, 78.7) mm Hg (significant between-group difference, p = 0.02). We had planned to recruit 150 women into the trial; hence, under-recruitment represents a major limitation of our results. Another limitation to our study was the low adherence to the exercise program, with only 50% of the women included in the intention-to-treat analysis adhering as described in the study protocol. Conclusions In this trial we did not observe a reduction in GWG among overweight/obese women who received a supervised exercise training program during their pregnancy. The incidence of GDM in late pregnancy seemed to be lower in the women randomized to exercise training than in the women receiving standard maternity care only. Systolic blood pressure in late pregnancy was also apparently lower in the exercise group than in the control group. These results indicate that supervised exercise training might be beneficial as a part of standard pregnancy care for overweight/obese women. Trial Registration ClinicalTrials.gov NCT01243554 PMID:27459375

  6. The selection and design of control conditions for randomized controlled trials of psychological interventions.

    PubMed

    Mohr, David C; Spring, Bonnie; Freedland, Kenneth E; Beckner, Victoria; Arean, Patricia; Hollon, Steven D; Ockene, Judith; Kaplan, Robert

    2009-01-01

    The randomized controlled trial (RCT) provides critical support for evidence-based practice using psychological interventions. The control condition is the principal method of removing the influence of unwanted variables in RCTs. There is little agreement or consistency in the design and construction of control conditions. Because control conditions have variable effects, the results of RCTs can depend as much on control condition selection as on the experimental intervention. The aim of this paper is to present a framework for the selection and design of control conditions for these trials. Threats to internal validity arising from modern RCT methodology are reviewed and reconsidered. The strengths and weaknesses of several categories of control conditions are examined, including the ones that are under experimental control, the ones that are under the control of clinical service providers, and no-treatment controls. Considerations in the selection of control conditions are discussed and several recommendations are proposed. The aim of this paper is to begin to define principles by which control conditions can be selected or developed in a manner that can assist both investigators and grant reviewers.

  7. A literature review on the representativeness of randomized controlled trial samples and implications for the external validity of trial results.

    PubMed

    Kennedy-Martin, Tessa; Curtis, Sarah; Faries, Douglas; Robinson, Susan; Johnston, Joseph

    2015-01-01

    Randomized controlled trials (RCTs) are conducted under idealized and rigorously controlled conditions that may compromise their external validity. A literature review was conducted of published English language articles that reported the findings of studies assessing external validity by a comparison of the patient sample included in RCTs reporting on pharmaceutical interventions with patients from everyday clinical practice. The review focused on publications in the fields of cardiology, mental health, and oncology. A range of databases were interrogated (MEDLINE; EMBASE; Science Citation Index; Cochrane Methodology Register). Double-abstract review and data extraction were performed as per protocol specifications. Out of 5,456 de-duplicated abstracts, 52 studies met the inclusion criteria (cardiology, n = 20; mental health, n = 17; oncology, n = 15). Studies either performed an analysis of the baseline characteristics (demographic, socioeconomic, and clinical parameters) of RCT-enrolled patients compared with a real-world population, or assessed the proportion of real-world patients who would have been eligible for RCT inclusion following the application of RCT inclusion/exclusion criteria. Many of the included studies concluded that RCT samples are highly selected and have a lower risk profile than real-world populations, with the frequent exclusion of elderly patients and patients with co-morbidities. Calculation of ineligibility rates in individual studies showed that a high proportion of the general disease population was often excluded from trials. The majority of studies (n = 37 [71.2 %]) explicitly concluded that RCT samples were not broadly representative of real-world patients and that this may limit the external validity of the RCT. Authors made a number of recommendations to improve external validity. Findings from this review indicate that there is a need to improve the external validity of RCTs such that physicians treating patients

  8. Ameliorating children's reading-comprehension difficulties: a randomized controlled trial.

    PubMed

    Clarke, Paula J; Snowling, Margaret J; Truelove, Emma; Hulme, Charles

    2010-08-01

    Children with specific reading-comprehension difficulties can read accurately, but they have poor comprehension. In a randomized controlled trial, we examined the efficacy of three interventions designed to improve such children's reading comprehension: text-comprehension (TC) training, oral-language (OL) training, and TC and OL training combined (COM). Children were assessed preintervention, midintervention, postintervention, and at an 11-month follow-up. All intervention groups made significant improvements in reading comprehension relative to an untreated control group. Although these gains were maintained at follow-up in the TC and COM groups, the OL group made greater gains than the other groups did between the end of the intervention and follow-up. The OL and COM groups also demonstrated significant improvements in expressive vocabulary compared with the control group, and this was a mediator of the improved reading comprehension of the OL and COM groups. We conclude that specific reading-comprehension difficulties reflect (at least partly) underlying oral-language weaknesses that can be effectively ameliorated by suitable teaching.

  9. Tacrolimus monotherapy in membranous nephropathy: a randomized controlled trial.

    PubMed

    Praga, M; Barrio, V; Juárez, G Fernández; Luño, J

    2007-05-01

    Membranous nephropathy is a common cause of nephrotic syndrome in adults. Although some patients with membranous nephropathy achieve a spontaneous remission, renal function continues to deteriorate in others. We conducted a prospective randomized trial evaluating monotherapy with tacrolimus to achieve complete or partial remission in patients with biopsy-proven membranous nephropathy. Twenty-five patients received tacrolimus (0.05 mg/kg/day) over 12 months with a 6-month taper, whereas 23 patients were in the control group. The probability of remission in the treatment group was 58, 82, and 94% after 6, 12, and 18 months but only 10, 24, and 35%, respectively in the control group. The decrease in proteinuria was significantly greater in the treatment group. Notably, six patients in the control group and only one in the treatment group reached the secondary end point of a 50% increase in their serum creatinine. No patient in the tacrolimus group showed a relapse during the taper period. Nephrotic syndrome reappeared in almost half of the patients who were in remission by the 18th month after tacrolimus withdrawal. We conclude that tacrolimus is a very useful therapeutic option for patients with membranous nephropathy and preserved renal function. The majority of patients experienced remission with a significant reduction in the risk for deteriorating renal function.

  10. Effects of nattokinase on blood pressure: a randomized, controlled trial.

    PubMed

    Kim, Ji Young; Gum, Si Nae; Paik, Jean Kyung; Lim, Hyo Hee; Kim, Kyong-Chol; Ogasawara, Kazuya; Inoue, Kenichi; Park, Sungha; Jang, Yangsoo; Lee, Jong Ho

    2008-08-01

    The objective of this study was to examine the effects of nattokinase supplementation on blood pressure in subjects with pre-hypertension or stage 1 hypertension. In a randomized, double-blind, placebo-controlled trial, 86 participants ranging from 20 to 80 years of age with an initial untreated systolic blood pressure (SBP) of 130 to 159 mmHg received nattokinase (2,000 FU/capsule) or a placebo capsule for 8 weeks. Seventy-three subjects completed the protocol. Compared with the control group, the net changes in SBP and diastolic blood pressure (DBP) were -5.55 mmHg (95% confidence interval [CI], -10.5 to -0.57 mmHg; p<0.05) and -2.84 mmHg (CI, -5.33 to -0.33 mmHg; p<0.05), respectively, after the 8-week intervention. The corresponding net change in renin activity was -1.17 ng/mL/h for the nattokinase group compared with the control group (p<0.05). In conclusion, nattokinase supplementation resulted in a reduction in SBP and DBP. These findings suggest that increased intake of nattokinase may play an important role in preventing and treating hypertension.

  11. Deprescribing in Frail Older People: A Randomised Controlled Trial

    PubMed Central

    Potter, Kathleen; Flicker, Leon; Page, Amy; Etherton-Beer, Christopher

    2016-01-01

    Objectives Deprescribing has been proposed as a way to reduce polypharmacy in frail older people. We aimed to reduce the number of medicines consumed by people living in residential aged care facilities (RACF). Secondary objectives were to explore the effect of deprescribing on survival, falls, fractures, hospital admissions, cognitive, physical, and bowel function, quality of life, and sleep. Methods Ninety-five people aged over 65 years living in four RACF in rural mid-west Western Australia were randomised in an open study. The intervention group (n = 47) received a deprescribing intervention, the planned cessation of non-beneficial medicines. The control group (n = 48) received usual care. Participants were monitored for twelve months from randomisation. Primary outcome was change in the mean number of unique regular medicines. All outcomes were assessed at baseline, six, and twelve months. Results Study participants had a mean age of 84.3±6.9 years and 52% were female. Intervention group participants consumed 9.6±5.0 and control group participants consumed 9.5±3.6 unique regular medicines at baseline. Of the 348 medicines targeted for deprescribing (7.4±3.8 per person, 78% of regular medicines), 207 medicines (4.4±3.4 per person, 59% of targeted medicines) were successfully discontinued. The mean change in number of regular medicines at 12 months was -1.9±4.1 in intervention group participants and +0.1±3.5 in control group participants (estimated difference 2.0±0.9, 95%CI 0.08, 3.8, p = 0.04). Twelve intervention participants and 19 control participants died within 12 months of randomisation (26% versus 40% mortality, p = 0.16, HR 0.60, 95%CI 0.30 to 1.22) There were no significant differences between groups in other secondary outcomes. The main limitations of this study were the open design and small participant numbers. Conclusions Deprescribing reduced the number of regular medicines consumed by frail older people living in residential care with no

  12. Directional control of hippocampal place fields.

    PubMed

    Jeffery, K J; Donnett, J G; Burgess, N; O'Keefe, J M

    1997-10-01

    Pyramidal cells in the rat hippocampus fire whenever the animal is in a particular place, suggesting that the hippocampus maintains a representation of the environment. Receptive fields of place cells (place fields) are largely determined by the distance of the rat from environmental walls. Because these walls are sometimes distinguishable only by their orientation with respect to the outside room, it has been hypothesised that a polarising directional input enables the cells to locate their fields off-centre in an otherwise symmetrical environment. We tested this hypothesis by gaining control of the rat's internal directional sense, independently of other cues, to see whether manipulating this sense could, by itself, produce a corresponding alteration in place field orientation. Place cells were recorded while rats foraged in a rectangular box, in the absence or presence of external room cues. With room cues masked, slow rotation of the rat and the box together caused the fields to rotate accordingly. Rotating the recording box alone by 180 degrees rarely caused corresponding field rotation, while rotating the rat alone 180 degrees outside the environment and then replacing it in the recording box almost always resulted in a corresponding rotation of the fields. This shows that place field orientation can be controlled by controlling the internal direction-sense of the rat, and it opens the door to psycho-physical exploration of the sensory basis of the direction sense. When room cues were present, distal visual cues predominated over internal cues in establishing place field orientation.

  13. Smoked cannabis for chronic neuropathic pain: a randomized controlled trial

    PubMed Central

    Ware, Mark A.; Wang, Tongtong; Shapiro, Stan; Robinson, Ann; Ducruet, Thierry; Huynh, Thao; Gamsa, Ann; Bennett, Gary J.; Collet, Jean-Paul

    2010-01-01

    -term safety and efficacy studies are indicated. (International Standard Randomised Controlled Trial Register no. ISRCTN68314063) PMID:20805210

  14. Randomized Controlled Trial of Calcitriol in Severe Sepsis

    PubMed Central

    Raed, Anas; Donnino, Michael W.; Ginde, Adit A.; Waikar, Sushrut S.

    2014-01-01

    Rationale: Vitamin D and its metabolites have potent immunomodulatory effects in vitro, including up-regulation of cathelicidin, a critical antimicrobial protein. Objectives: We investigated whether administration of 1,25-dihydroxyvitamin D (calcitriol) to critically ill patients with sepsis would have beneficial effects on markers of innate immunity, inflammation, and kidney injury. Methods: We performed a double-blind, randomized, placebo-controlled, physiologic study among 67 critically ill patients with severe sepsis or septic shock. Patients were randomized to receive a single dose of calcitriol (2 μg intravenously) versus placebo. The primary outcome was plasma cathelicidin protein levels assessed 24 hours after study drug administration. Secondary outcomes included leukocyte cathelicidin mRNA expression, plasma cytokine levels (IL-10, IL-6, tumor necrosis factor-α, IL-1β, and IL-2), and urinary kidney injury markers. Measurements and Main Results: Patients randomized to calcitriol (n = 36) versus placebo (n = 31) had similar plasma cathelicidin protein levels at 24 hours (P = 0.16). Calcitriol-treated patients had higher cathelicidin (P = 0.04) and IL-10 (P = 0.03) mRNA expression than placebo-treated patients 24 hours after study drug administration. Plasma cytokine levels (IL-10, IL-6, tumor necrosis factor-α, IL-1β, and IL-2) and urinary kidney injury markers were similar in calcitriol- versus placebo-treated patients (P > 0.05 for all comparisons). Calcitriol had no effect on clinical outcomes nor were any adverse effects observed. Conclusions: Calcitriol administration did not increase plasma cathelicidin protein levels in critically ill patients with sepsis and had mixed effects on other immunomodulatory markers. Additional phase II trials investigating the dose and timing of calcitriol as a therapeutic agent in specific sepsis phenotypes may be warranted. Clinical trial registered with www.clinicaltrials.gov (NCT 01689441). PMID:25029202

  15. Cysticercosis Control: Bringing Advances to the Field

    PubMed Central

    O’Neal, SE; Winthrop, KL; Gonzalez, AE

    2011-01-01

    Progress towards Taenia solium control is evident in the development of new technologies and in increasing regional coordination, yet disease eradication remains unlikely in the near future. In the meantime, translation of research advances into functioning control programs is necessary to address the ongoing disease burden in endemic areas. Multiple screening assays, effective treatments for both human and porcine infection, and vaccines blocking transmission to pigs are currently available. Strategies based on identification and treatment of T. solium adult tapeworms, as well as interventions that block cysticercosis acquisition in pigs have temporarily reduced transmission. Building on these successes with controlled community trials in varying endemic scenarios will drive progress towards regional elimination. PMID:21731303

  16. Diabetes Prevention in Hispanics: Report From a Randomized Controlled Trial

    PubMed Central

    Carosso, Elizabeth; Mariscal, Norma; Islas, Ilda; Ibarra, Genoveva; Holte, Sarah; Copeland, Wade; Linde, Sandra; Thompson, Beti

    2014-01-01

    Introduction Hispanics are at increased risk of developing type 2 diabetes. Lifestyle interventions are effective in preventing diabetes and restoring glucose regulation. Methods We recruited Hispanic men and women (N = 320) who were residents of the Lower Yakima Valley, Washington, aged 18 years or older with hemoglobin A1c (HbA1c) levels higher than 6% to a parallel 2-arm randomized-controlled trial conducted from 2008 through 2012. The trial compared participants in the intervention arm, who received an immediate educational curriculum (n = 166), to participants in the control arm, who received a delayed educational curriculum (n = 154). The home-based curriculum consisted of 5 sessions led by community health workers and was designed to inform participants about diabetes, diabetes treatment, and healthy dietary and physical activity behaviors. Participants were randomly assigned to the intervention and control arms, and analysts were blinded as to participant arm. We evaluated intervention effects on HbA1c levels; frequency (times per week) of fruit and vegetable consumption; and frequency (times per week) of mild, moderate, and strenuous leisure-time physical activity. At baseline, 3 months, and 6 months after randomization, participants completed a questionnaire and provided a blood sample. Analysts were blinded to intervention arm. Results The immediate intervention group (−0.64% [standard error (SE) 0.10]) showed a significant improvement in HbA1c scores (–37.5%, P = .04) compared with the delayed intervention group (–0.44%, P = .14). No significant changes were seen for dietary end points or changes in physical activity. We did observe a trend of greater increases in frequency of moderate and vigorous physical activity and a smaller increase in mild physical activity in the immediate intervention group than in the delayed intervention group. Conclusion This home-based intervention delivered by CHWs was associated with a clinically and statistically

  17. The "House Calls" trial: a randomized controlled trial to reduce racial disparities in live donor kidney transplantation: rationale and design.

    PubMed

    Rodrigue, James R; Pavlakis, Martha; Egbuna, Ogo; Paek, Matthew; Waterman, Amy D; Mandelbrot, Didier A

    2012-07-01

    Despite a substantially lower rate of live donor kidney transplantation among Black Americans compared to White Americans, there are few systematic efforts to reduce this racial disparity. This paper describes the rationale and design of a randomized controlled trial evaluating the comparative effectiveness of three different educational interventions for increasing live donor kidney transplantation in Black Americans. This trial is a single-site, urn-randomized controlled trial with a planned enrollment of 180 Black Americans awaiting kidney transplantation. Patients are randomized to receive transplant education in one of three education conditions: through group education at their homes (e.g., House Calls), or through group (Group-Based) or individual education (Individual Counseling) in the transplant center. The primary outcome of the trial is the occurrence of a live donor kidney transplant, with secondary outcomes including living donor inquiries and evaluations as well as changes in patient live donor kidney transplantation readiness, willingness, knowledge, and concerns. Sex, age, dialysis status, and quality of life are evaluated as moderating factors. Findings from this clinical trial have the potential to inform strategies for reducing racial disparities in live donor kidney transplantation. Similar trials have been developed recently to broaden the evaluation of House Calls as an innovative disparity-reducing intervention in kidney transplantation. PMID:22510472

  18. Quantifying generalization from trial-by-trial behavior of adaptive systems that learn with basis functions: theory and experiments in human motor control.

    PubMed

    Donchin, Opher; Francis, Joseph T; Shadmehr, Reza

    2003-10-01

    During reaching movements, the brain's internal models map desired limb motion into predicted forces. When the forces in the task change, these models adapt. Adaptation is guided by generalization: errors in one movement influence prediction in other types of movement. If the mapping is accomplished with population coding, combining basis elements that encode different regions of movement space, then generalization can reveal the encoding of the basis elements. We present a theory that relates encoding to generalization using trial-by-trial changes in behavior during adaptation. We consider adaptation during reaching movements in various velocity-dependent force fields and quantify how errors generalize across direction. We find that the measurement of error is critical to the theory. A typical assumption in motor control is that error is the difference between a current trajectory and a desired trajectory (DJ) that does not change during adaptation. Under this assumption, in all force fields that we examined, including one in which force randomly changes from trial to trial, we found a bimodal generalization pattern, perhaps reflecting basis elements that encode direction bimodally. If the DJ was allowed to vary, bimodality was reduced or eliminated, but the generalization function accounted for nearly twice as much variance. We suggest, therefore, that basis elements representing the internal model of dynamics are sensitive to limb velocity with bimodal tuning; however, it is also possible that during adaptation the error metric itself adapts, which affects the implied shape of the basis elements.

  19. Asthma self-management model: randomized controlled trial.

    PubMed

    Olivera, Carolina M X; Vianna, Elcio Oliveira; Bonizio, Roni C; de Menezes, Marcelo B; Ferraz, Erica; Cetlin, Andrea A; Valdevite, Laura M; Almeida, Gustavo A; Araujo, Ana S; Simoneti, Christian S; de Freitas, Amanda; Lizzi, Elisangela A; Borges, Marcos C; de Freitas, Osvaldo

    2016-10-01

    Information for patients provided by the pharmacist is reflected in adhesion to treatment, clinical results and patient quality of life. The objective of this study was to assess an asthma self-management model for rational medicine use. This was a randomized controlled trial with 60 asthmatic patients assigned to attend five modules presented by a pharmacist (intervention group) and 59 patients in the control group. Data collection was performed before and after this 4-month intervention and included an evaluation of asthma knowledge, lifestyle, inhaler techniques, adhesion to treatment, pulmonary function and quality of life. An economic viability analysis was also performed. The intervention group obtained an increase in asthma knowledge scores of 58.3-79.5% (P < 0.001). In this group, there was also an increase in the number of individuals who practiced physical exercise (36-43%), in the number of correct replies regarding the use of inhalers, in the percentage of adherent patients, and in quality of life scores for all domains. We concluded that this asthma self-management model was effective in improving the quality of life of asthma patients. PMID:27473571

  20. Acupuncture for posttraumatic stress disorder: a randomized controlled pilot trial.

    PubMed

    Hollifield, Michael; Sinclair-Lian, Nityamo; Warner, Teddy D; Hammerschlag, Richard

    2007-06-01

    The purpose of the study was to evaluate the potential efficacy and acceptability of accupuncture for posttraumatic stress disorder (PTSD). People diagnosed with PTSD were randomized to either an empirically developed accupuncture treatment (ACU), a group cognitive-behavioral therapy (CBT), or a wait-list control (WLC). The primary outcome measure was self-reported PTSD symptoms at baseline, end treatment, and 3-month follow-up. Repeated measures MANOVA was used to detect predicted Group X Time effects in both intent-to-treat (ITT) and treatment completion models. Compared with the WLC condition in the ITT model, accupuncture provided large treatment effects for PTSD (F [1, 46] = 12.60; p < 0.01; Cohen's d = 1.29), similar in magnitude to group CBT (F [1, 47] = 12.45; p < 0.01; d = 1.42) (ACU vs. CBT, d = 0.29). Symptom reductions at end treatment were maintained at 3-month follow-up for both interventions. Accupuncture may be an efficacious and acceptable nonexposure treatment option for PTSD. Larger trials with additional controls and methods are warranted to replicate and extend these findings. PMID:17568299

  1. Exercise during pregnancy attenuates prenatal depression: a randomized controlled trial.

    PubMed

    Perales, M; Refoyo, I; Coteron, J; Bacchi, M; Barakat, R

    2015-03-01

    Recent studies have estimated the prevalence of depression during pregnancy to be between 10% and 30%, which is higher than that in the postpartum period. Pharmacological treatment during pregnancy is difficult because of the possible side effects of antidepressants on the mother and the fetus. The aim of this study was to examine whether a supervised exercise program (EP) reduces depressive symptoms in pregnant women. A randomized controlled trial was designed. One hundred eighty four healthy pregnant women from Fuenlabrada Hospital were included (31.37 ± 3.62 years). Women from the exercise group (EG) participated in a supervised EP consisting of three, 55- to 60-min sessions per week throughout pregnancy. The main outcome measure was the patients' depression level assessed by means of the Center for Epidemiologic Studies Depression Scale (CES-D). A total of 167 pregnant women were analyzed; 90 were allocated to the EG and 77 to the control group (CG). Significant differences were found between groups at the end of the study in CES-D scores (EG: 7.67 ± 6.30 vs. CG: 11.34 ± 9.74, p = .005) and in percentages of pregnant women depressed (EG: n = 11/12.2% vs. CG: n = 19/24.7%, p = .04). Our results show that supervised physical exercise during pregnancy reduces the level of depression and its incidence in pregnant women.

  2. Online psychoeducational support for infertile women: a randomized controlled trial

    PubMed Central

    Cousineau, Tara M.; Green, Traci C.; Corsini, Evelyn; Seibring, A; Showstack, Marianne T.; Applegarth, Linda; Davidson, Marie; Perloe, Mark

    2008-01-01

    BACKGROUND The study goal was to develop and test the effectiveness of a brief online education and support program for female infertility patients. METHODS A randomized-controlled trial was conducted. Using a Solomon-four group design, 190 female patients were recruited from three US fertility centers and were randomized into two experimental and two no-treatment control groups. The psychological outcomes assessed included infertility distress, infertility self-efficacy, decisional conflict, marital cohesion and coping style. Program dosage and satisfaction were also assessed at four weeks follow-up. RESULTS Women exposed to the online program significantly improved in the area of social concerns (P = 0.038) related to infertility distress, and felt more informed about a medical decision with which they were contending (P = 0.037). Trends were observed for decreased global stress (P = 0.10), sexual concerns (P = 0.059), distress related to child-free living (P = 0.063), increased infertility self-efficacy (P = 0.067) and decision making clarity (P = 0.079). A dosage response was observed in the experimental groups for women who spent >60 min online for decreased global stress (P = 0.028) and increased self efficacy (P = 0.024). CONCLUSIONS This evidence-based eHealth program for women experiencing infertility suggests that a web-based patient education intervention can have beneficial effects in several psychological domains and may be a cost effective resource for fertility practices. PMID:18089552

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

    USGS Publications Warehouse

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

    2001-01-01

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

  4. Guidelines to site selection for population surveillance and mosquito control trials: a case study from Mauritius.

    PubMed

    Iyaloo, Diana P; Elahee, Khouaildi B; Bheecarry, Ambicadutt; Lees, Rosemary Susan

    2014-04-01

    Many novel approaches to controlling mosquito vectors through the release of sterile and mass reared males are being developed in the face of increasing insecticide resistance and other limitations of current methods. Before full scale release programmes can be undertaken there is a need for surveillance of the target population, and investigation of parameters such as dispersal and longevity of released, as compared to wild males through mark-release-recapture (MRR) and other experiments, before small scale pilot trials can be conducted. The nature of the sites used for this field work is crucial to ensure that a trial can feasibly collect sufficient and relevant information, given the available resources and practical limitations, and having secured the correct regulatory, community and ethical approvals and support. Mauritius is considering the inclusion of the sterile insect technique (SIT), for population reduction of Aedes albopictus, as a component of the Ministry of Health and Quality of Life's 'Operational Plan for Prevention and Control of Chikungunya and Dengue'. As part of an investigation into the feasibility of integrating the SIT into the Integrated Vector Management (IVM) scheme in Mauritius a pilot trial is planned. Two potential sites have been selected for this purpose, Pointe des Lascars and Panchvati, villages in the North East of the country, and population surveillance has commenced. This case study will here be used to explore the considerations which go into determining the most appropriate sites for mosquito field research. Although each situation is unique, and an ideal site may not be available, this discussion aims to help researchers to consider and balance the important factors and select field sites that will meet their needs.

  5. Central Retinal Enrichment Supplementation Trials (CREST): Design and Methodology of the CREST Randomized Controlled Trials

    PubMed Central

    Beatty, Stephen; Stack, Jim; Dennison, Jessica; O’Regan, Sarah; Meagher, Katherine A.; Peto, Tunde; Nolan, John

    2014-01-01

    Purpose The Central Retinal Enrichment Supplementation Trials (CREST) aim to investigate the potential impact of macular pigment (MP) enrichment, following supplementation with a formulation containing 10 mg lutein (L), 2 mg zeaxanthin (Z) and 10 mg meso-zeaxanthin (MZ), on visual function in normal subjects (Trial 1) and in subjects with early age-related macular degeneration (AMD; Trial 2). Methods CREST is a single center, double-blind, randomized clinical trial. Trial 1 (12-month follow-up) subjects are randomly assigned to a formulation containing 10 mg L, 10 mg MZ and 2 mg Z (n = 60) or placebo (n = 60). Trial 2 (24-month follow-up) subjects are randomly assigned to a formulation containing 10 mg L, 10 mg MZ, 2 mg Z plus 500 mg vitamin C, 400 IU vitamin E, 25 mg zinc and 2 mg copper (Intervention A; n = 75) or 10 mg L and 2 mg Z plus 500 mg vitamin C, 400 IU vitamin E, 25 mg zinc and 2 mg copper (Intervention B; n = 75). Contrast sensitivity (CS) at 6 cycles per degree represents the primary outcome measure in each trial. Secondary outcomes include: CS at other spatial frequencies, MP, best-corrected visual acuity, glare disability, photostress recovery, light scatter, cognitive function, foveal architecture, serum carotenoid concentrations, and subjective visual function. For Trial 2, AMD morphology, reading speed and reading acuity are also being recorded. Conclusions CREST is the first study to investigate the impact of supplementation with all three macular carotenoids in the context of a large, double-blind, randomized clinical trial. PMID:24621122

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

    SciTech Connect

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

    1995-12-31

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

  7. When ethics constrains clinical research: trial design of control arms in "greater than minimal risk" pediatric trials.

    PubMed

    de Melo-Martín, Inmaculada; Sondhi, Dolan; Crystal, Ronald G

    2011-09-01

    For more than three decades clinical research in the United States has been explicitly guided by the idea that ethical considerations must be central to research design and practice. In spite of the centrality of this idea, attempting to balance the sometimes conflicting values of advancing scientific knowledge and protecting human subjects continues to pose challenges. Possible conflicts between the standards of scientific research and those of ethics are particularly salient in relation to trial design. Specifically, the choice of a control arm is an aspect of trial design in which ethical and scientific issues are deeply entwined. Although ethical quandaries related to the choice of control arms may arise when conducting any type of clinical trials, they are conspicuous in early phase gene transfer trials that involve highly novel approaches and surgical procedures and have children as the research subjects. Because of children's and their parents' vulnerabilities, in trials that investigate therapies for fatal, rare diseases affecting minors, the scientific and ethical concerns related to choosing appropriate controls are particularly significant. In this paper we use direct gene transfer to the central nervous system to treat late infantile neuronal ceroid lipofuscinosis to illustrate some of these ethical issues and explore possible solutions to real and apparent conflicts between scientific and ethical considerations.

  8. Job Maintenance through Supported Employment PLUS: A Randomized Controlled Trial

    PubMed Central

    Telle, Nils-Torge; Moock, Jörn; Heuchert, Sandra; Schulte, Vivian; Rössler, Wulf; Kawohl, Wolfram

    2016-01-01

    Sickness absence from work due to experienced distress and mental health issues has continuously increased over the past years in Germany. To investigate how this alarming development can be counteracted, we conducted a randomized controlled trial evaluating a job coaching intervention to maintain the working capacity of members of staff and ultimately prevent sickness absence. Our sample included N = 99 employees who reported mental distress due to work-related problems. The intervention group (n = 58) received between 8 and 12 individual job coaching sessions in which they worked with a professional job coach to reduce their mental distress. The control group (n = 41) received a brochure about mental distress. Data were collected before the start of the study, at the end of the job coaching intervention, and at a 3-month follow-up. These data included the number of sickness absence days as the primary outcome and questionnaire measures to assess burnout indicators, life satisfaction, and work-related experiences and behaviors. Compared with the control group, the results indicated no reduction in sickness absence in the intervention group but fewer depressive symptoms, a heightened ability of the participants to distance themselves from work, more experience of work-related success, less depletion of emotional resources, and a greater satisfaction with life when participants had received the job coaching. Thus, although we could not detect a reduction in sickness absence between the groups, job coaching was shown to be a viable intervention technique to benefit employees by contributing to re-establish their mental health. We discuss the implications of the study and outline future research. PMID:27703964

  9. Methods for testing theory and evaluating impact in randomized field trials

    PubMed Central

    Brown, C. Hendricks; Wang, Wei; Kellam, Sheppard G.; Muthén, Bengt O.; Petras, Hanno; Toyinbo, Peter; Poduska, Jeanne; Ialongo, Nicholas; Wyman, Peter A.; Chamberlain, Patricia; Sloboda, Zili; MacKinnon, David P.; Windham, Amy

    2008-01-01

    Randomized field trials provide unique opportunities to examine the effectiveness of an intervention in real world settings and to test and extend both theory of etiology and theory of intervention. These trials are designed not only to test for overall intervention impact but also to examine how impact varies as a function of individual level characteristics, context, and across time. Examination of such variation in impact requires analytical methods that take into account the trial’s multiple nested structure and the evolving changes in outcomes over time. The models that we describe here merge multilevel modeling with growth modeling, allowing for variation in impact to be represented through discrete mixtures—growth mixture models—and nonparametric smooth functions—generalized additive mixed models. These methods are part of an emerging class of multilevel growth mixture models, and we illustrate these with models that examine overall impact and variation in impact. In this paper, we define intent-to-treat analyses in group-randomized multilevel field trials and discuss appropriate ways to identify, examine, and test for variation in impact without inflating the Type I error rate. We describe how to make causal inferences more robust to misspecification of covariates in such analyses and how to summarize and present these interactive intervention effects clearly. Practical strategies for reducing model complexity, checking model fit, and handling missing data are discussed using six randomized field trials to show how these methods may be used across trials randomized at different levels. PMID:18215473

  10. Using historical control information for the design and analysis of clinical trials with overdispersed count data.

    PubMed

    Gsteiger, Sandro; Neuenschwander, Beat; Mercier, Francois; Schmidli, Heinz

    2013-09-20

    Results from clinical trials are never interpreted in isolation. Previous studies in a similar setting provide valuable information for designing a new trial. For the analysis, however, the use of trial-external information is challenging and therefore controversial, although it seems attractive from an ethical or efficiency perspective. Here, we consider the formal use of historical control data on lesion counts in a multiple sclerosis trial. The approach to incorporating historical data is Bayesian, in that historical information is captured in a prior that accounts for between-trial variability and hence leads to discounting of historical data. We extend the meta-analytic-predictive approach, a random-effects meta-analysis of historical data combined with the prediction of the parameter in the new trial, from normal to overdispersed count data of individual-patient or aggregate-trial format. We discuss the prior derivation for the lesion mean count in the control group of the new trial for two populations. For the general population (without baseline enrichment), with 1936 control patients from nine historical trials, between-trial variability was moderate to substantial, leading to a prior effective sample size of about 45 control patients. For the more homogenous population (with enrichment), with 412 control patients from five historical trials, the prior effective sample size was approximately 63 patients. Although these numbers are small relative to the historical data, they are fairly typical in settings where between-trial heterogeneity is moderate. For phase II, reducing the number of control patients by 45 or by 63 may be an attractive option in many multiple sclerosis trials.

  11. Analysis of a large dataset of mycorrhiza inoculation field trials on potato shows highly significant increases in yield.

    PubMed

    Hijri, Mohamed

    2016-04-01

    An increasing human population requires more food production in nutrient-efficient systems in order to simultaneously meet global food needs while reducing the environmental footprint of agriculture. Arbuscular mycorrhizal fungi (AMF) have the potential to enhance crop yield, but their efficiency has yet to be demonstrated in large-scale crop production systems. This study reports an analysis of a dataset consisting of 231 field trials in which the same AMF inoculant (Rhizophagus irregularis DAOM 197198) was applied to potato over a 4-year period in North America and Europe under authentic field conditions. The inoculation was performed using a liquid suspension of AMF spores that was sprayed onto potato seed pieces, yielding a calculated 71 spores per seed piece. Statistical analysis showed a highly significant increase in marketable potato yield (ANOVA, P < 0.0001) for inoculated fields (42.2 tons/ha) compared with non-inoculated controls (38.3 tons/ha), irrespective of trial year. The average yield increase was 3.9 tons/ha, representing 9.5 % of total crop yield. Inoculation was profitable with a 0.67-tons/ha increase in yield, a threshold reached in almost 79 % of all trials. This finding clearly demonstrates the benefits of mycorrhizal-based inoculation on crop yield, using potato as a case study. Further improvements of these beneficial inoculants will help compensate for crop production deficits, both now and in the future.

  12. Pilot Field Trial of the EG95 Vaccine Against Ovine Cystic Echinococcosis in Rio Negro, Argentina: Second Study of Impact

    PubMed Central

    Larrieu, Edmundo; Mujica, Guillermo; Gauci, Charles G.; Vizcaychipi, Katherina; Seleiman, Marcos; Herrero, Eduardo; Labanchi, José Luis; Araya, Daniel; Sepúlveda, Luis; Grizmado, Claudia; Calabro, Arnoldo; Talmon, Gabriel; Poggio, Thelma Verónica; Crowley, Pablo; Cespedes, Graciela; Santillán, Graciela; García Cachau, Mariela; Lamberti, Roberto; Gino, Lilia; Donadeu, Meritxell; Lightowlers, Marshall W.

    2015-01-01

    Background Cystic echinococcosis (CE) is an important zoonotic disease caused by the cestode parasite Echinococcus granulosus. It occurs in many parts of the world where pastoral activities predominate, including the Rio Negro province of Argentina. Although CE control activities have been undertaken in the western regions of Rio Negro for more than two decades, the disease continues to remain prevalent in both the human and livestock animal populations. Vaccination of animal intermediate hosts of CE with the EG95 vaccine may provide a new opportunity to improve the effectiveness of CE control measures, although data are lacking about field application of the vaccine. Aims Evaluate the impact of EG95 vaccination in sheep on the transmission of Echinococcus granulosus in a field environment. Methodology Two trial sites were established in western Rio Negro province within indigenous communities. Vaccination of lambs born into one trial site was introduced and continued for 6 years. Prior to initiation of the trial, and at the end of the trial, the prevalence of CE in sheep was determined by necropsy. Weaned lambs received two injections of EG95 vaccine, approximately one month apart, and a single booster injection one year later. Vaccination was not implemented at the second trial site. A total of 2725 animals were vaccinated in the first year. Animals from this cohort as well as age-matched sheep from the control area were evaluated by necropsy. Key results Introduction of the vaccine led to a statistically significant in the number and size of hydatid cysts in comparison to the situation prior to the introduction of the vaccine, or compared to CE prevalence in the control area where the vaccine was not applied. The prevalence of infection in the vaccinated area was also significantly reduced by 62% compared to the re-intervention level, being lower than the prevalence seen in the control area, although the difference from the control area after the intervention

  13. FIELD TRIALS OF NEWLY DEVELOPED POSITIVE DISPLACEMENT SUBMERSIBLE PUMP

    SciTech Connect

    Rob Beard

    2003-10-01

    The purpose of this grant was to evaluate under real world conditions the performance of a new type of downhole pump, the hydraulically driven submersible diaphragm pump. This pump is supplied by Pumping Solutions Incorporated, Albuquerque NM. The original scope of the project was to install 10 submersible pumps, and compare that to 10 similar installations of rod pumps. As an operator, the system as tested was not ready for prime time, but has shown the ability to reduce costs, and increase production, if run times can be improved. The PSI group did improve the product and offered excellent service. The latest design appears to be much better, but more test data is needed to show short run life is not a problem. PSI and Beard Oil intend to continue testing the pump with non-government funding. The testing to date did not uncover any fundamental problems that would preclude the widespread use of this pump, and as an operator, I believe that with further improvement and testing, the pump can have a significant impact on stripper well costs. On the positive side, the pump was easy to run, was more power efficient then a rod pump, and is the only submersible that could handle the large quantities of solids typical of the production environment found at the Weber field and in CMB production. The product shows much promise for the future, and with continued design and testing, this type of submersible pump has the potential to become the standard of the industry.

  14. Comparison of methadone and buprenorphine for opiate detoxification (LEEDS trial): a randomised controlled trial

    PubMed Central

    Wright, Nat MJ; Sheard, Laura; Adams, Clive E; Rushforth, Bruno J; Harrison, Wendy; Bound, Nicole; Hart, Roger; Tompkins, Charlotte NE

    2011-01-01

    Background Many opiate users require prescribed medication to help them achieve abstinence, commonly taking the form of a detoxification regime. In UK prisons, drug users are nearly universally treated for their opiate use by primary care clinicians, and once released access GP services where 40% of practices now treat drug users. There is a paucity of evidence evaluating methadone and buprenorphine (the two most commonly prescribed agents in the UK) for opiate detoxification. Aim To evaluate whether buprenorphine or methadone help to achieve drug abstinence at completion of a reducing regimen for heroin users presenting to UK prison health care for detoxification. Design Open-label, pragmatic, randomised controlled trial in three prison primary healthcare departments in the north of England. Method Prisoners (n = 306) using illicit opiates were recruited and given daily sublingual buprenorphine or oral methadone, in the context of routine care, over a standard reduced regimen of not more than 20 days. The primary outcome measure was abstinence from illicit opiates at 8 days post detoxification, as indicated by urine test (self-report/clinical notes where urine sample was not feasible). Secondary outcomes were also recorded. Results Abstinence was ascertained for 73.7% at 8 days post detoxification (urine sample = 52.6%, self report = 15.2%, clinical notes = 5.9%). There was no statistically significant difference in the odds of achieving abstinence between methadone and buprenorphine (odds ratio [OR] = 1.69; 95% confidence interval [CI] = 0.81 to 3.51; P = 0.163). Abstinence was associated solely with whether or not the participant was still in prison at that time (15.22 times the odds; 95% CI = 4.19 to 55.28). The strongest association for lasting abstinence was abstinence at an earlier time point. Conclusion There is equal clinical effectiveness between methadone and buprenorphine in achieving abstinence from opiates at 8 days post detoxification within prison

  15. Coblation versus traditional tonsillectomy: A double blind randomized controlled trial

    PubMed Central

    Omrani, Mohammadreza; Barati, Behrouz; Omidifar, Navid; Okhovvat, Ahmad Reza; Hashemi, Seyed Amirhossein Ghazizadeh

    2012-01-01

    BACKGROUND: Coblation tonsillectomy is a new surgical technique and demands further research to be proven as a suitable and standard method of tonsillectomy. This study compares coblation and traditional tonsillectomy techniques in view of their advantages and complications. METHODS: In a prospective double-blind randomized controlled trial information on operation time, intraoperative blood loss, postoperative pain, time needed to regain the normal diet and activity and postoperative hemorrhage were gathered and compared between two groups containing 47 patients in each group. RESULTS: We found statistically significant differences in operation time (p < 0.05), intraoperative blood loss (p < 0.05), postoperative pain (p < 0.001), time needed to find back the normal diet (p < 0.001) and normal activity (p < 0.001). However, post operation hemorrhage (p > 0.5) was not significantly different between two groups. CONCLUSIONS: This study revealed a significantly less intraoperative or postoperative complications and morbidity in coblation tonsillectomy in comparison with traditional method. Coblation was associated with less pain and quick return to normal diet and daily activity. These findings addressed coblation tonsillectomy as an advanced method. PMID:23248656

  16. Evaluating cognitive effort in a randomized controlled trial.

    PubMed

    Turner, Travis H; Renfroe, Jenna B; Morella, Kristen; Marriott, Bernadette P

    2016-09-01

    Many randomized controlled trials (RCTs) of neuropsychiatric conditions involve cognitive outcome measures; however, validity of cognitive data relies on adequate effort during testing, and such screening is seldom performed. Given well-established rates of 10 to 30% poor effort in clinical settings, this is not a trivial concern. This preliminary study evaluated effort during cognitive testing in an RCT of omega-3 supplementation to reduce suicidality in a high-risk psychiatric population. An interim analysis of sustained attentions measures from the Connors Performance Test (CPT-2) at baseline for the first 60 participants was conducted. Previously validated cut points to detect insufficient effort on the CPT-2 were applied. At baseline, 12% (7) were identified as giving poor effort. Follow-up analyses indicated less psychiatric distress and suicidality among those who gave poor effort. Results suggest comparable likelihood of a poor effort on cognitive testing in clinical and RCT participation. Reduced psychiatric distress in the poor effort group raises concern regarding interpretation of other measures. The importance of screening cognitive data for effort in RCTs is highlighted. Future studies will examine effort at follow-up visits, and explore relationships to attrition, adherence, and response to treatment. Copyright © 2016 John Wiley & Sons, Ltd.

  17. Panax ginseng in randomised controlled trials: a systematic review.

    PubMed

    Shergis, Johannah L; Zhang, Anthony L; Zhou, Wenyu; Xue, Charlie C

    2013-07-01

    Panax ginseng C.A. Meyer is a common herb with many purported health benefits. However, there is no conclusive evidence supporting its use in the treatment of any particular disease. We conducted a systematic review to evaluate randomised controlled trials. Four English databases were searched with no publication date restriction. Included studies evaluated P. ginseng in patients with any type of disease or in healthy individuals. We assessed the quality of studies using the Cochrane risk of bias tool. Of the 475 potentially relevant studies, 65 met the inclusion criteria. These studies examined P. ginseng's effects on psychomotor performance (17 studies), physical performance (ten), circulatory system (eight), glucose metabolism (six), the respiratory system (five), erectile dysfunction (four), immunomodulation (four), quality of life/mood (four), antioxidant function (two), cancer (two), menopausal symptoms (two) and dry mouth (one). The risk of bias was unclear in most studies. Authors evaluated adverse events in 40 studies, with 135 minor events and no serious adverse events reported. P. ginseng shows promising results for improving glucose metabolism and moderating the immune response. This may have implications for several diseases including type 2 diabetes and chronic respiratory conditions. Further studies are needed to explore P. ginseng's potential as an effective treatment for these and other health conditions.

  18. Continuous subcutaneous infusion of morphine vs. hydromorphone: a controlled trial.

    PubMed

    Miller, M G; McCarthy, N; O'Boyle, C A; Kearney, M

    1999-07-01

    Seventy-four patients were included in a double-blind, randomized, controlled trial comparing the analgesic efficacy and adverse effects of hydromorphone and morphine delivered by continuous subcutaneous infusion. Patients completed the Memorial Pain Assessment Card and a checklist of opioid-related adverse effects immediately before commencing subcutaneous infusion and 24, 48, and 72 hours later. An assessment tool was developed for the 60 patients who were too ill to complete their own questionnaire. The tool demonstrated excellent inter-rater reliability. Thirty-four percent of patients in the hydromorphone group and 27% of those in the morphine group died before completion of the study (P = 0.66). The hydromorphone group required more analgesia for breakthrough pain in the first 24 hours of the study (P = 0.03) and had a greater improvement in the behavior of frowning on movement and the comfort visual analogue scale (P = 0.08) over the course of the study. Adverse effects were rare and similar in both groups. This study found hydromorphone to be at least as effective as morphine when delivered by continuous subcutaneous infusion.

  19. Nurse Navigators in Early Cancer Care: A Randomized, Controlled Trial

    PubMed Central

    Wagner, Edward H.; Ludman, Evette J.; Aiello Bowles, Erin J.; Penfold, Robert; Reid, Robert J.; Rutter, Carolyn M.; Chubak, Jessica; McCorkle, Ruth

    2014-01-01

    Purpose To determine whether a nurse navigator intervention improves quality of life and patient experience with care for people recently given a diagnosis of breast, colorectal, or lung cancer. Patients and Methods Adults with recently diagnosed primary breast, colorectal, or lung cancer (n = 251) received either enhanced usual care (n = 118) or nurse navigator support for 4 months (n = 133) in a two-group cluster randomized, controlled trial with primary care physicians as the units of randomization. Patient-reported measures included the Functional Assessment of Cancer Therapy–General (FACT-G) Quality of Life scale, three subscales of the Patient Assessment of Chronic Illness Care (PACIC), and selected subscales from a cancer adaptation of the Picker Institute's patient experience survey. Self-report measures were collected at baseline, 4 months, and 12 months. Automated administrative data were used to assess time to treatment and total health care costs. Results There were no significant differences between groups in FACT-G scores. Nurse navigator patients reported significantly higher scores on the PACIC and reported significantly fewer problems with care, especially psychosocial care, care coordination, and information, as measured by the Picker instrument. Cumulative costs after diagnosis did not differ significantly between groups, but lung cancer costs were $6,852 less among nurse navigator patients. Conclusion Compared with enhanced usual care, nurse navigator support for patients with cancer early in their course improves patient experience and reduces problems in care, but did not differentially affect quality of life. PMID:24276777

  20. ETHICAL ISSUES IN FIELD TRIALS OF GENETICALLY MODIFIED DISEASE-RESISTANT MOSQUITOES

    PubMed Central

    RESNIK, DAVID B.

    2012-01-01

    Mosquito-borne diseases take a tremendous toll on human populations, especially in developing nations. In the last decade, scientists have developed mosquitoes that have been genetically modified to prevent transmission of mosquito-borne diseases, and field trials have been conducted. Some mosquitoes have been rendered infertile, some have been equipped with a vaccine they transmit to humans, and some have been designed to resist diseases. This article focuses on ethical issues raised by field trials of disease-resistant, genetically modified mosquitoes. Some of these issues include: protecting the public and the environment from harm, balancing benefits and risks, collaborating with the local community, avoiding exploitation, and safeguarding the rights and welfare of research subjects. One of the most difficult problems involves protecting the welfare of community members who will be impacted by the release of mosquitoes but who are not enrolled in the study as research subjects. To address this concern, field trials should take place only when the targeted disease is a significant public health problem in an isolated area, the benefits of the trial for the community are likely to outweigh the risks, community leaders approve of the trial, and there are measures in place to protect the welfare of un-enrolled community members, such as informing the community about the study and offering free treatment to people who contract mosquito-borne diseases. Since the justification of any field trial depends on a careful examination of the scientific and ethical issues, proposed studies should be evaluated on a case-by-case basis. PMID:23279283

  1. Key Items to Get Right When Conducting a Randomized Controlled Trial in Education

    ERIC Educational Resources Information Center

    Coalition for Evidence-Based Policy, 2005

    2005-01-01

    This is a checklist of key items to get right when conducting a randomized controlled trial to evaluate an educational program or practice ("intervention"). It is intended as a practical resource for researchers and sponsors of research, describing items that are often critical to the success of a randomized controlled trial. A significant…

  2. Online Adaptation and Over-Trial Learning in Macaque Visuomotor Control

    PubMed Central

    Braun, Daniel A.; Aertsen, Ad; Paz, Rony; Vaadia, Eilon; Rotter, Stefan; Mehring, Carsten

    2011-01-01

    When faced with unpredictable environments, the human motor system has been shown to develop optimized adaptation strategies that allow for online adaptation during the control process. Such online adaptation is to be contrasted to slower over-trial learning that corresponds to a trial-by-trial update of the movement plan. Here we investigate the interplay of both processes, i.e., online adaptation and over-trial learning, in a visuomotor experiment performed by macaques. We show that simple non-adaptive control schemes fail to perform in this task, but that a previously suggested adaptive optimal feedback control model can explain the observed behavior. We also show that over-trial learning as seen in learning and aftereffect curves can be explained by learning in a radial basis function network. Our results suggest that both the process of over-trial learning and the process of online adaptation are crucial to understand visuomotor learning. PMID:21720526

  3. Effects of Academic Vocabulary Instruction for Linguistically Diverse Adolescents: Evidence from a Randomized Field Trial

    ERIC Educational Resources Information Center

    Lesaux, Nonie K.; Kieffer, Michael J.; Kelley, Joan G.; Harris, Julie Russ

    2014-01-01

    We conducted a randomized field trial to test an academic vocabulary intervention designed to bolster the language and literacy skills of linguistically diverse sixth-grade students (N = 2,082; n = 1,469 from a home where English is not the primary language), many demonstrating low achievement, enrolled in 14 urban middle schools. The 20-week…

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

    Technology Transfer Automated Retrieval System (TEKTRAN)

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

  5. The Role of Treatment Fidelity on Outcomes during a Randomized Field Trial of an Autism Intervention

    ERIC Educational Resources Information Center

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

    2013-01-01

    This randomized field trial comparing Strategies for Teaching based on Autism Research and Structured Teaching enrolled educators in 33 kindergarten-through-second-grade autism support classrooms and 119 students, aged 5-8 years in the School District of Philadelphia. Students were assessed at the beginning and end of the academic year using the…

  6. Effects of a Voluntary Summer Reading Intervention on Reading Achievement: Results from a Randomized Field Trial

    ERIC Educational Resources Information Center

    Kim, James S.

    2006-01-01

    The effects of a voluntary summer reading intervention were assessed in a randomized field trial involving 552 students in 10 schools. In this study, fourth-grade children received eight books to read during their summer vacation and were encouraged by their teachers to practice oral reading at home with a family member and to use comprehension…

  7. Quality assurance in radiotherapy: from radiation physics to patient- and trial-oriented control procedures.

    PubMed

    Bernier, J; Horiot, J C; Poortmans, P

    2002-03-01

    The stepwise process of the EORTC Quality Assurance Programme in Radiotherapy is described in function of two main criteria: the targets of the quality control procedures implemented, in Radiation Physics and clinical research, by the EORTC Radiotherapy Group and the development of both trial- and patient-oriented quality systems. This exhaustive program, which started in 1982, is characterised by three main periods. The first one was fully dedicated to pioneer steps in Radiation Physics measurements, on-site audits and inventories of human resources, staff workload and department infrastructure in institutions participating to EORTC trials. During the second period, which started in the late 1980s, a series of quality systems were implemented to test the compliance of the investigators to follow protocol guidelines, through the use of standard and uniform control procedures like the dummy runs, in order to tackle systematic errors in the participating institutions. Finally, the third period, which took place in the 1990s, was essentially patient-oriented, thanks to large scale individual case reviews, to check the validity of data recording and reporting processes and trace random errors throughout the radiotherapy treatments. Most of the results collected during these two decades allowed the implementation of well codified quality control procedures which, nowadays, can be used outside the field of clinical research, by national societies or bodies willing to improve treatment standards on a large scale.

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

    PubMed

    Leme, Ana Carolina Barco; Philippi, Sonia Tucunduva

    2015-07-01

    The purpose of this article is to describe the study design, protocol, and baseline results of the "Healthy Habits, Healthy Girls" program. The intervention is being evaluated through a randomized controlled trial in 10 public schools in the city of São Paulo, Brazil. Data on the following variables were collected and assessed at baseline and will be reevaluated at 7 and 12 months: body mass index, waist circumference, dietary intake, nutrition, physical activity, social cognitive mediators, physical activity level, sedentary behaviors, self-rated physical status, and overall self-esteem. According to the baseline results, 32.4% and 23.4% of girls were overweight in the intervention and control groups, respectively, and in both groups a higher percentage failed to meet daily recommendations for moderate and vigorous physical activity and maximum screen time (TV, computer, mobile devices). There were no significant differences between the groups for most of the variables, except age (p = 0.000) and waist circumference (p = 0.014). The study showed a gap in the Brazilian literature on protocols for randomized controlled trials to prevent obesity among youth. The current study may thus be an important initial contribution to the field. PMID:26248094

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

    PubMed

    Leme, Ana Carolina Barco; Philippi, Sonia Tucunduva

    2015-07-01

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

  10. Feasibility of surgical randomised controlled trials with a placebo arm: a systematic review

    PubMed Central

    Wartolowska, Karolina; Collins, Gary S; Hopewell, Sally; Judge, Andrew; Dean, Benjamin J F; Rombach, Ines; Beard, David J; Carr, Andrew J

    2016-01-01

    Objectives To find evidence, either corroborating or refuting, for many persisting beliefs regarding the feasibility of carrying out surgical randomised controlled trials with a placebo arm, with emphasis on the challenges related to recruitment, funding, anaesthesia or blinding. Design Systematic review. Data sources and study selection The analysis involved studies published between 1959 and 2014 that were identified during an earlier systematic review of benefits and harms of placebo-controlled surgical trials published in 2014. Results 63 trials were included in the review. The main problem reported in many trials was a very slow recruitment rate, mainly due to the difficulty in finding eligible patients. Existing placebo trials were funded equally often from commercial and non-commercial sources. General anaesthesia or sedation was used in 41% of studies. Among the reviewed trials, 81% were double-blinded, and 19% were single-blinded. Across the reviewed trials, 96% (range 50–100%) of randomised patients completed the study. The withdrawal rate during the study was similar in the surgical and in the placebo groups. Conclusions This review demonstrated that placebo-controlled surgical trials are feasible, at least for procedures with a lower level of invasiveness, but also that recruitment is difficult. Many of the presumed challenges to undertaking such trials, for example, funding, anaesthesia or blinding of patients and assessors, were not reported as obstacles to completion in any of the reviewed trials. PMID:27008687

  11. Field trials assessing deltamethrin (Butox®) treatments of sheep against Culicoides species.

    PubMed

    Weiher, Wiebke; Bauer, Burkhard; Mehlitz, Dieter; Nijhof, Ard M; Clausen, Peter-Henning

    2014-07-01

    Culicoides (Diptera: Ceratopogonidae) biting midges may transmit various diseases of economic importance, including bluetongue virus (BTV) and Schmallenberg (SV) virus, which affect ruminants. During the outbreak of BTV in central and northern Europe in 2006, and in the absence of BTV vaccines, many national veterinary services recommended the treatment of susceptible livestock with pyrethroids as a first-line defense against biting midges, although these insecticides were officially not registered and authorized for use against Culicoides midges. The efficacy of Butox® pour on (7.5 mg deltamethrin/mL) against biting midges was therefore evaluated in a double-blinded GCP field trial performed in Brandenburg, Germany. Forty female Merino sheep with an average body weight of 38 kg (±7 kg) were used for the study. Twenty randomly selected sheep were treated with 10 mL Butox® pour on. The remaining 20 sheep were left untreated and served as a control group. Midge collections took place in two separate drop traps covering two crush pens with three confined treated/untreated sheep standing inside, on weekdays at 1, 7, 14, 21, 28, and 35 days post treatment. A total of 19,057 midges were collected during this period. Midges were identified as belonging to the subgenus Avaritia, Fox (84.6%) and subgenus Culicoides, Latreille (15.4%). A total of 12,031 midges were collected inside the drop trap containing untreated sheep, in comparison to 7,026 midges collected from the vicinity of the treated sheep. Significantly, more midges had fed on control compared to treated sheep with 757 and 103 engorged midges, respectively. The results indicate that treatment of sheep with Butox® pour on provided a significant decrease in Culicoides feeding rates under field conditions for at least 35 days.

  12. Pen and field trials of a new anticoagulant rodenticide flocoumafen against the house mouse (Mus musculus L.).

    PubMed

    Rowe, F P; Bradfield, A; Swinney, T

    1985-12-01

    The efficacy of flocoumafen, a novel anticoagulant rodenticide, was evaluated in feeding tests on confined and free-living populations of house mice (Mus musculus L.). In four pen trials, family groups of laboratory-reared wild mice were conditioned to feeding on plain foods and then offered flocoumafen at 0.005% in pinhead oatmeal bait. All 68 mice, comprising juvenile and adult animals, died within 10 days. Ten field trials were carried out, using the same formulated poison bait, against mice infesting farm buildings. Mean treatment success, estimated from live-capture and mortality data, ranged between 87.1 and 100%. The performance of flocoumafen is compared with that of difenacoum, bromadiolone and brodifacoum used at the same concentration in oatmeal bait. Flocoumafen gave an equally effective but quicker kill of mice. It is concluded that flocoumafen is a promising new rodenticide for the control of M. musculus. PMID:3841547

  13. Pen and field trials of a new anticoagulant rodenticide flocoumafen against the house mouse (Mus musculus L.).

    PubMed Central

    Rowe, F. P.; Bradfield, A.; Swinney, T.

    1985-01-01

    The efficacy of flocoumafen, a novel anticoagulant rodenticide, was evaluated in feeding tests on confined and free-living populations of house mice (Mus musculus L.). In four pen trials, family groups of laboratory-reared wild mice were conditioned to feeding on plain foods and then offered flocoumafen at 0.005% in pinhead oatmeal bait. All 68 mice, comprising juvenile and adult animals, died within 10 days. Ten field trials were carried out, using the same formulated poison bait, against mice infesting farm buildings. Mean treatment success, estimated from live-capture and mortality data, ranged between 87.1 and 100%. The performance of flocoumafen is compared with that of difenacoum, bromadiolone and brodifacoum used at the same concentration in oatmeal bait. Flocoumafen gave an equally effective but quicker kill of mice. It is concluded that flocoumafen is a promising new rodenticide for the control of M. musculus. PMID:3841547

  14. Experiences of being a control group: lessons from a UK-based randomized controlled trial of group singing as a health promotion initiative for older people.

    PubMed

    Skingley, Ann; Bungay, Hilary; Clift, Stephen; Warden, June

    2014-12-01

    Existing randomized controlled trials within the health field suggest that the concept of randomization is not always well understood and that feelings of disappointment may occur when participants are not placed in their preferred arm. This may affect a study's rigour and ethical integrity if not addressed. We aimed to test whether these issues apply to a healthy volunteer sample within a health promotion trial of singing for older people. Written comments from control group participants at two points during the trial were analysed, together with individual semi-structured interviews with a small sample (n = 11) of this group. We found that motivation to participate in the trial was largely due to the appeal of singing and disappointment resulted from allocation to the control group. Understanding of randomization was generally good and feelings of disappointment lessened over time and with a post-research opportunity to sing. Findings suggest that measures should be put in place to minimize the potential negative impacts of randomized controlled trials in health promotion research.

  15. Field-measured drag area is a key correlate of level cycling time trial performance

    PubMed Central

    Peterman, James E.; Lim, Allen C.; Ignatz, Ryan I.; Edwards, Andrew G.

    2015-01-01

    Drag area (Ad) is a primary factor determining aerodynamic resistance during level cycling and is therefore a key determinant of level time trial performance. However, Ad has traditionally been difficult to measure. Our purpose was to determine the value of adding field-measured Ad as a correlate of level cycling time trial performance. In the field, 19 male cyclists performed a level (22.1 km) time trial. Separately, field-determined Ad and rolling resistance were calculated for subjects along with projected frontal area assessed directly (AP) and indirectly (Est AP). Also, a graded exercise test was performed to determine \\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{upgreek} \\usepackage{mathrsfs} \\setlength{\\oddsidemargin}{-69pt} \\begin{document} }{}$\\dot {V}{O}_{2}$\\end{document}V˙O2 peak, lactate threshold (LT), and economy. \\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{upgreek} \\usepackage{mathrsfs} \\setlength{\\oddsidemargin}{-69pt} \\begin{document} }{}$\\dot {V}{O}_{2}$\\end{document}V˙O2 peak (\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{upgreek} \\usepackage{mathrsfs} \\setlength{\\oddsidemargin}{-69pt} \\begin{document} }{}$\\mathrm{l}~\\min ^{-1}$\\end{document}lmin−1) and power at LT were significantly correlated to power measured during the time trial (r = 0.83 and 0.69, respectively) but were not significantly correlated to performance time (r = − 0.42 and −0.45). The correlation with performance time improved significantly (p < 0.05) when these variables were normalized to Ad. Of note, Ad alone was better correlated to performance time (r = 0.85, p < 0.001) than any combination of non-normalized physiological

  16. A Yoga Intervention for Posttraumatic Stress: A Preliminary Randomized Control Trial.

    PubMed

    Jindani, Farah; Turner, Nigel; Khalsa, Sat Bir S

    2015-01-01

    Yoga may be effective in the reduction of PTSD symptomology. The purpose of this study was to evaluate the impact of a Kundalini Yoga (KY) treatment on PTSD symptoms and overall wellbeing. To supplement the current field of inquiry, a pilot randomized control trial (RCT) was conducted comparing an 8-session KY intervention with a waitlist control group. 80 individuals with current PTSD symptoms participated. Both groups demonstrated changes in PTSD symptomology but yoga participants showed greater changes in measures of sleep, positive affect, perceived stress, anxiety, stress, and resilience. Between-groups effect sizes were small to moderate (0.09-0.25). KY may be an adjunctive or alternative intervention for PTSD. Findings indicate the need for further yoga research to better understand the mechanism of yoga in relation to mental and physical health, gender and ethnic comparisons, and short- and long-term yoga practice for psychiatric conditions. PMID:26366179

  17. Magnetic Field Control of Combustion Dynamics

    NASA Astrophysics Data System (ADS)

    Barmina, I.; Valdmanis, R.; Zake, M.; Kalis, H.; Marinaki, M.; Strautins, U.

    2016-08-01

    Experimental studies and mathematical modelling of the effects of magnetic field on combustion dynamics at thermo-chemical conversion of biomass are carried out with the aim of providing control of the processes developing in the reaction zone of swirling flame. The joint research of the magnetic field effect on the combustion dynamics includes the estimation of this effect on the formation of the swirling flame dynamics, flame temperature and composition, providing analysis of the magnetic field effects on the flame characteristics. The results of experiments have shown that the magnetic field exerts the influence on the flow velocity components by enhancing a swirl motion in the flame reaction zone with swirl-enhanced mixing of the axial flow of volatiles with cold air swirl, by cooling the flame reaction zone and by limiting the thermo-chemical conversion of volatiles. Mathematical modelling of magnetic field effect on the formation of the flame dynamics confirms that the electromagnetic force, which is induced by the electric current surrounding the flame, leads to field-enhanced increase of flow vorticity by enhancing mixing of the reactants. The magnetic field effect on the flame temperature and rate of reactions leads to conclusion that field-enhanced increase of the flow vorticity results in flame cooling by limiting the chemical conversion of the reactants.

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

    PubMed

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

    2015-05-01

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

  19. Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial

    PubMed Central

    Gomes, Evelim L. F. D.; Carvalho, Celso R. F.; Peixoto-Souza, Fabiana Sobral; Teixeira-Carvalho, Etiene Farah; Mendonça, Juliana Fernandes Barreto; Stirbulov, Roberto; Sampaio, Luciana Maria Malosá; Costa, Dirceu

    2015-01-01

    Objective The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma. Design A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20) or a treadmill group (TG; n = 16). Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO), maximum exercise testing (Bruce protocol) and lung function. Results No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p < 0.05). Although the mean energy expenditure at rest and during exercise training was similar for both groups, the maximum energy expenditure was higher in the VGG. Conclusion The present findings strongly suggest that aerobic training promoted by an active video game had a positive impact on children with asthma in terms of clinical control, improvementin their exercise capacity and a reductionin pulmonary inflammation. Trial Registration Clinicaltrials.gov NCT01438294 PMID:26301706

  20. Laparoscopically assisted ventriculoperitoneal shunt placement: a prospective randomized controlled trial.

    PubMed

    Schucht, Philippe; Banz, Vanessa; Trochsler, Markus; Iff, Samuel; Krähenbühl, Anna Katharina; Reinert, Michael; Beck, Jürgen; Raabe, Andreas; Candinas, Daniel; Kuhlen, Dominique; Mariani, Luigi

    2015-05-01

    OBJECT In ventriculoperitoneal (VP) shunt surgery, laparoscopic assistance can be used for placement of the peritoneal catheter. Until now, the efficacy of laparoscopic shunt placement has been investigated only in retrospective and nonrandomized prospective studies, which have reported decreased distal shunt dysfunction rates in patients undergoing laparascopic placement compared with mini-laparotomy cohorts. In this randomized controlled trial the authors compared rates of shunt failure in patients who underwent laparoscopic surgery for peritoneal catheter placement with rates in patients who underwent traditional mini-laparotomy. METHODS One hundred twenty patients scheduled for VP shunt surgery were randomized to laparoscopic surgery or mini-laparotomy for insertion of the peritoneal catheter. The primary endpoint was the rate of overall shunt complication or failure within the first 12 months after surgery. Secondary endpoints were distal shunt failure, overall complication/ failure, duration of surgery and hospitalization, and morbidity. RESULTS The overall shunt complication/failure rate was 15% (9 of 60 cases) in the laparoscopic group and 18.3% (11 of 60 cases) in the mini-laparotomy group (p = 0.404). Patients in the laparoscopic group had no distal shunt failures; in contrast, 5 (8%) of 60 patients in the mini-laparotomy group experienced distal shunt failure (p = 0.029). Intraoperative complications occurred in 2 patients (both in the laparoscopic group), and abdominal pain led to catheter removal in 1 patient per group. Infections occurred in 1 patient in the laparoscopic group and 3 in the mini-laparotomy group. The mean durations of surgery and hospitalization were similar in the 2 groups. CONCLUSIONS While overall shunt failure rates were similar in the 2 groups, the use of laparoscopic shunt placement significantly reduced the rate of distal shunt failure compared with mini-laparotomy.

  1. Spinal cord stimulation with interleaved pulses: a randomized, controlled trial.

    PubMed

    North, Richard B; Kidd, David H; Olin, John; Sieracki, Jeffrey M; Boulay, Marc

    2007-10-01

    Objectives.  The development of multicontact electrodes and programmable, implanted pulse generators has increased the therapeutic success of spinal cord stimulation (SCS) by enhancing the ability to capture and maintain pain/paresthesia overlap. This study sought to determine if interleaved stimulation and/or frequency doubling improves pain/paresthesia overlap in patients with failed back surgery syndrome. Methods.  Using a patient-interactive computer system that quantifies SCS performance and presents stimulation settings in randomized, double-blind fashion, we compared the effect on pain/paresthesia overlap of interleaved stimulation (rapidly interleaved pulse trains using two different contact combinations) vs. standard treatment with a single contact combination, controlling for frequency doubling. Stimulation amplitude (charge per phase, as determined by varying pulse voltage or width) was adjusted to a subjectively comfortable intensity (usage amplitude), which was maintained for all trials in each patient. The number of percutaneous spinal electrodes used (one or two) and the phase angle between interleaved pulses were additional study variables. Results.  Multivariate analysis of 266 test results from 15 patients revealed a statistically significant (p ≤ 0.05) association between increased computer-calculated pain/paresthesia overlap and 1) high- and low-frequency interleaved stimulation using two combinations of contacts and 2) frequency doubling using one combination. We found no significant effect for electrode configuration (single or dual), pulse width matching, or phase angle. Conclusions.  The statistically significant advantages we observed for SCS with interleaved stimulation are explained, at least in part, by the effects of frequency doubling. These findings have important implications for the design and adjustment of pulse generators. PMID:22150894

  2. Facing depression with botulinum toxin: a randomized controlled trial.

    PubMed

    Wollmer, M Axel; de Boer, Claas; Kalak, Nadeem; Beck, Johannes; Götz, Thomas; Schmidt, Tina; Hodzic, Muris; Bayer, Ursula; Kollmann, Thilo; Kollewe, Katja; Sönmez, Daniela; Duntsch, Katja; Haug, Martin D; Schedlowski, Manfred; Hatzinger, Martin; Dressler, Dirk; Brand, Serge; Holsboer-Trachsler, Edith; Kruger, Tillmann H C

    2012-05-01

    Positive effects on mood have been observed in subjects who underwent treatment of glabellar frown lines with botulinum toxin and, in an open case series, depression remitted or improved after such treatment. Using a randomized double-blind placebo-controlled trial design we assessed botulinum toxin injection to the glabellar region as an adjunctive treatment of major depression. Thirty patients were randomly assigned to a verum (onabotulinumtoxinA, n = 15) or placebo (saline, n = 15) group. The primary end point was change in the 17-item version of the Hamilton Depression Rating Scale six weeks after treatment compared to baseline. The verum and the placebo groups did not differ significantly in any of the collected baseline characteristics. Throughout the sixteen-week follow-up period there was a significant improvement in depressive symptoms in the verum group compared to the placebo group as measured by the Hamilton Depression Rating Scale (F((6,168)) = 5.76, p < 0.001, η(2) = 0.17). Six weeks after a single treatment scores of onabotulinumtoxinA recipients were reduced on average by 47.1% and by 9.2% in placebo-treated participants (F((1,28)) = 12.30, p = 0.002, η(2) = 0.31, d = 1.28). The effect size was even larger at the end of the study (d = 1.80). Treatment-dependent clinical improvement was also reflected in the Beck Depression Inventory, and in the Clinical Global Impressions Scale. This study shows that a single treatment of the glabellar region with botulinum toxin may shortly accomplish a strong and sustained alleviation of depression in patients, who did not improve sufficiently on previous medication. It supports the concept, that the facial musculature not only expresses, but also regulates mood states. PMID:22364892

  3. Tryptophan Supplementation and Postoperative Delirium – A Randomized Controlled Trial

    PubMed Central

    Robinson, Thomas N.; Dunn, Christina L.; Adams, Jill C.; Hawkins, Carrie L.; Tran, Zung V.; Raeburn, Christopher D.; Moss, Marc

    2014-01-01

    Background/Objectives Tryptophan deficiency has been associated with increased incidence of postoperative delirium. Therefore, we hypothesized that the post-operative administration of tryptophan would be beneficial for elderly surgical patients who are at higher risk of developing post-operative delirium. Design Randomized, double-blind, placebo controlled trial. Setting: Participants A total of 325 individuals aged 60 years and older undergoing major elective operations requiring a postoperative intensive care unit admission. Intervention L-tryptophan, 1 gram orally, three times daily or placebo was started following the operation and continued for up to three days postoperatively. Measurements Delirium and its motor subtypes were measured using the Confusion Assessment Method-ICU and the Richmond Agitation and Sedation Scale. The primary outcome for between groups comparison was the incidence of excitatory (mixed and hyperactive) postoperative delirium. The secondary outcomes for comparison were the incidence and duration of overall postoperative delirium. Results The overall incidence of postoperative delirium was 39% (116) (95% confidence interval 34% to 44%). The percentages of patients with excitatory delirium in the tryptophan and placebo groups were 17% and 9% (p=0.176), and the duration of excitatory delirium was 3.3±1.7 and 3.1±1.9 days (p=0.741). The percentage of patients with overall delirium in the tryptophan and placebo groups was 40% and 37% (p=0.597), and the duration of overall delirium was 2.9±1.8 and 2.4±1.6 days (p=0.167). Conclusion Postoperative tryptophan supplementation in older adults undergoing major elective operations requiring postoperative intensive care unit admission demonstrated no efficacy in reducing the incidence of postoperative excitatory delirium or overall delirium, and the duration of excitatory or overall delirium. PMID:25112175

  4. Rural providers' access to online resources: a randomized controlled trial

    PubMed Central

    Hall, Laura J.; McElfresh, Karen R.; Warner, Teddy D.; Stromberg, Tiffany L.; Trost, Jaren; Jelinek, Devin A.

    2016-01-01

    Objective The research determined the usage and satisfaction levels with one of two point-of-care (PoC) resources among health care providers in a rural state. Methods In this randomized controlled trial, twenty-eight health care providers in rural areas were stratified by occupation and region, then randomized into either the DynaMed or the AccessMedicine study arm. Study participants were physicians, physician assistants, and nurses. A pre- and post-study survey measured participants' attitudes toward different information resources and their information-seeking activities. Medical student investigators provided training and technical support for participants. Data analyses consisted of analysis of variance (ANOVA), paired t tests, and Cohen's d statistic to compare pre- and post-study effects sizes. Results Participants in both the DynaMed and the AccessMedicine arms of the study reported increased satisfaction with their respective PoC resource, as expected. Participants in both arms also reported that they saved time in finding needed information. At baseline, both arms reported too little information available, which increased to “about right amounts of information” at the completion of the study. DynaMed users reported a Cohen's d increase of +1.50 compared to AccessMedicine users' reported use of 0.82. DynaMed users reported d2 satisfaction increases of 9.48 versus AccessMedicine satisfaction increases of 0.59 using a Cohen's d. Conclusion Participants in the DynaMed arm of the study used this clinically oriented PoC more heavily than the users of the textbook-based AccessMedicine. In terms of user satisfaction, DynaMed users reported higher levels of satisfaction than the users of AccessMedicine. PMID:26807050

  5. Randomised controlled trial of intrapartum fetal heart rate monitoring.

    PubMed Central

    Mahomed, K.; Nyoni, R.; Mulambo, T.; Kasule, J.; Jacobus, E.

    1994-01-01

    OBJECTIVE--To compare effectiveness of different methods of monitoring intrapartum fetal heart rate. DESIGN--Prospective randomised controlled trial. SETTING--Referral maternity hospital, Harare, Zimbabwe. SUBJECTS--1255 women who were 37 weeks or more pregnant with singleton cephalic presentation and normal fetal heart rate before entry into study. INTERVENTIONS--Intermittent monitoring of fetal heart rate by electronic monitoring, Doppler ultrasound, use of Pinard stethoscope by a research midwife, or routine use of Pinard stethoscope by attending midwife. MAIN OUTCOME MEASURES--Abnormal fetal heart rate patterns, need for operative delivery for fetal distress, neonatal mortality, Apgar scores, admission to neonatal unit, neonatal seizures, and hypoxic ischaemic encephalopathy. RESULTS--Abnormalities in fetal heart rate were detected in 54% (172/318) of the electronic monitoring group, 32% (100/312) of the ultrasonography group, 15% (47/310) of the Pinard stethoscope group, and 9% (28/315) of the routine monitoring group. Caesarean sections were performed for 28% (89%), 24% (76), 10% (32), and 15% (46) of the four groups respectively. Neonatal outcome was best in the ultrasonography group: hypoxic ischaemic encephalopathy occurred in two, one, seven, and 10 cases in the four groups respectively; neonatal seizures occurred only in the last two groups (six and nine cases respectively); and deaths occurred in eight, two, five, and nine cases respectively. CONCLUSIONS--Abnormalities in fetal heart rate were more reliably detected by Doppler ultrasonography than with Pinard stethoscope, and its use resulted in good perinatal outcome. The use of relatively cheap ultrasound monitors should be further evaluated and promoted in obstetric units caring for high risk pregnancies in developing countries with scarce resources. PMID:8136665

  6. A multistrategy control system for field controllers of astronomical instruments

    NASA Astrophysics Data System (ADS)

    Zhu, Dan; Zhu, Yuhua

    2010-07-01

    As well-known, system on a programmable chip (SOPC) is widely used in a variety of field control systems , due to their flexible configurations and intelligent stand-alone characteristics. They are also increasingly used in astronomical instrument control nowadays. For those complex and diverse systems, a number of different control strategies are stored in FLASH, but the controller of on-chip determines which one to load. At the same time, it can be switched intelligently and remotely to form a multi-strategy control system, so as to extend the control functions and achieve system on-line reconfiguration quickly. In this paper we describe a design concept and realization method of a multistrategy control system on the basis of FPGA-based system on a chip. Its hardware core is Altera's Cyclone series EP3C25 chip .In SOPC BUILDER development environment ,a control system is constructed, which consists of NIOS II soft core as CPU ,REMOTE_UPDATE IP core and control algorithms as well. The concept and design has been verified in the field controllers for various astronomical applications. Satisfactory results have been obtained.

  7. Magnetic field regulation control system analysis

    SciTech Connect

    Badelt, Steven W.

    1996-05-01

    This study comprises (1) an analytical characterization of the Cameca ion microscope`s magnetic field regulation circuitry and (2) comparisons between the analytical predictions and the measured performance of the control system. It is the first step in a project to achieve routine field regulation better than 10ppm. The control loop was decomposed into functional subcircuits and simulated in SPICE to determine DC, AC, and transient response. Transfer functions were extracted from SPICE, simplified, and analyzed in MATLAB. Both SPICE and MATLAB simulations were calculated for step inputs, and these results were compared to actual measurements. Magnetic field fluctuations were measured at high mass resolving power. The frequency spectrum of the fluctuations was analyzed by FFT. Difficulties encountered and implications for future work are discussed.

  8. Nitrates and bone turnover (NABT) - trial to select the best nitrate preparation: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Organic nitrates uncouple bone turnover, improve bone mineral density, and improve trabecular and cortical components of bone. These changes in turnover, strength and geometry may translate into an important reduction in fractures. However, before proceeding with a large fracture trial, there is a need to identify the nitrate formulation that has both the greatest efficacy (with regards to bone turnover markers) and gives the fewest headaches. Ascertaining which nitrate formulation this may be is the purpose of the current study. Methods and design This will be an open-label randomized, controlled trial conducted at Women’s College Hospital comparing five formulations of nitrates for their effects on bone turnover markers and headache. We will recruit postmenopausal women age 50 years or older with no contraindications to nitroglycerin. Our trial will consist of a run-in phase and a treatment phase. We will enroll 420 women in the run-in phase, each to receive all of the 5 potential treatments in random order for 2 days, each with a 2-day washout period between treatments. Those who tolerate all formulations will enter the 12-week treatment phase and be randomly assigned to one of five groups: 0.3 mg sublingual nitroglycerin tablet, 0.6 mg of the sublingual tablet, a 20 mg tablet of isosorbide mononitrate, a 160 mg nitroglycerin transdermal patch (used for 8 h), and 15 mg of nitroglycerin ointment as used in a previous trial by our group. We will continue enrolment until we have randomized 210 women or 35 women per group. Concentrations of bone formation (bone-specific alkaline phosphatase and procollagen type I N-terminal propeptide) and bone resorption (C-telopeptides of collagen crosslinks and N-terminal crosslinks of collagen) agents will be measured in samples taken at study entry (the start of the run in phase) and 12 weeks. Subjects will record the frequency and severity of headaches daily during the run-in phase and then monthly after that. We

  9. Are acupoints specific for diseases? A systematic review of the randomized controlled trials with sham acupuncture controls

    PubMed Central

    2010-01-01

    Background The results of many clinical trials and experimental studies regarding acupoint specificity are contradictory. This review aims to investigate whether a difference in efficacy exists between ordinary acupuncture on specific acupoints and sham acupuncture controls on non-acupoints or on irrelevant acupoints. Methods Databases including Medline, Embase, AMED and Chinese Biomedical Database were searched to identify randomized controlled trials published between 1998 and 2009 that compared traditional body acupuncture on acupoints with sham acupuncture controls on irrelevant acupoints or non-acupoints with the same needling depth. The Cochrane Collaboration's tool for assessing risk of bias was employed to address the quality of the included trials. Results Twelve acupuncture clinical trials with sham acupuncture controls were identified and included in the review. The conditions treated varied. Half of the included trials had positive results on the primary outcomes and demonstrated acupoint specificity. However, among those six trials (total sample size: 985) with low risk of bias, five trials (sample size: 940) showed no statistically significant difference between proper and sham acupuncture treatments. Conclusion This review did not demonstrate the existence of acupoint specificity. Further clinical trials with larger sample sizes, optimal acupuncture treatment protocols and appropriate sham acupuncture controls are required to resolve this important issue. PMID:20145733

  10. Report of a joint DMRQC/Organon field trial to detect hepatitis A IgM by ELISA.

    PubMed

    Supran, E M; Craske, J; Hart, R J; Kurtz, J B; Parry, J V; Skidmore, S J; Gardner, P S

    1983-10-01

    The results of a field trial of a joint DMRQC/Organon ELISA kit for the detection of hepatitis A IgM antibody are reported. The participating laboratories were asked to use the kit to test a panel of 360 specimens consisting of duplicate coded samples of 180 sera. The panel was also tested by MACRIA in the Virus Reference Laboratory, Colindale. The ELISA was shown to be specific and sensitive giving good discrimination between acute and late convalescent hepatitis A sera. It was proposed that the same cut-off control as is used in the RIA (equivalent to 10 RIA units) should be adopted for the ELISA also.

  11. Complementary feeding: a Global Network cluster randomized controlled trial

    PubMed Central

    2011-01-01

    Background Inadequate and inappropriate complementary feeding are major factors contributing to excess morbidity and mortality in young children in low resource settings. Animal source foods in particular are cited as essential to achieve micronutrient requirements. The efficacy of the recommendation for regular meat consumption, however, has not been systematically evaluated. Methods/Design A cluster randomized efficacy trial was designed to test the hypothesis that 12 months of daily intake of beef added as a complementary food would result in greater linear growth velocity than a micronutrient fortified equi-caloric rice-soy cereal supplement. The study is being conducted in 4 sites of the Global Network for Women's and Children's Health Research located in Guatemala, Pakistan, Democratic Republic of the Congo (DRC) and Zambia in communities with toddler stunting rates of at least 20%. Five clusters per country were randomized to each of the food arms, with 30 infants in each cluster. The daily meat or cereal supplement was delivered to the home by community coordinators, starting when the infants were 6 months of age and continuing through 18 months. All participating mothers received nutrition education messages to enhance complementary feeding practices delivered by study coordinators and through posters at the local health center. Outcome measures, obtained at 6, 9, 12, and 18 months by a separate assessment team, included anthropometry; dietary variety and diversity scores; biomarkers of iron, zinc and Vitamin B12 status (18 months); neurocognitive development (12 and 18 months); and incidence of infectious morbidity throughout the trial. The trial was supervised by a trial steering committee, and an independent data monitoring committee provided oversight for the safety and conduct of the trial. Discussion Findings from this trial will test the efficacy of daily intake of meat commencing at age 6 months and, if beneficial, will provide a strong rationale

  12. A field trial for an ex-situ bioremediation of a drilling mud-polluted site.

    PubMed

    Rojas-Avelizapa, N G; Roldán-Carrillo, T; Zegarra-Martínez, H; Muñoz-Colunga, A M; Fernández-Linares, L C

    2007-01-01

    The remediation of drilling mud-polluted sites in the Southeast of Mexico is a top priority for Mexican oil industry. The objective of this work was to find a technology to remediate these sites. A field trial was performed by composting in biopiles, where four 1ton soil-biopiles were established, one treatment in triplicate and one unamended biopile. Amended biopiles were added with nutrients to get a C/N/P ratio of 100/3/0.5 plus a bulking agent (straw) at a soil/straw ratio of 97/3. Moisture content was maintained around 30-35%. Results showed that, after 180 d, total petroleum hydrocarbon (TPH) concentrations decreased from 99300+/-23000mgTPHkg(-1) soil to 5500+/-770mgTPHkg(-1) for amended biopiles and to 22900+/-7800mgTPHkg(-1) for unamended biopile. An undisturbed soil control showed no change in TPH concentrations. Gas chromatographic analysis showed residual alkyl dibenzothiophene type compounds. Highest bacterial counts were observed during the first 30 d which correlated with highest TPH removal, whereas fungal count increased at the end of the experimentation period. Results suggested an important role of the straw, nutrient addition and water content in stimulating aerobic microbial activity and thus hydrocarbon removal. This finding opens an opportunity to remediate old polluted sites with recalcitrant and high TPH concentration.

  13. Restoration of a Mediterranean forest after a fire: bioremediation and rhizoremediation field-scale trial.

    PubMed

    Pizarro-Tobías, Paloma; Fernández, Matilde; Niqui, José Luis; Solano, Jennifer; Duque, Estrella; Ramos, Juan-Luis; Roca, Amalia

    2015-01-01

    Forest fires pose a serious threat to countries in the Mediterranean basin, often razing large areas of land each year. After fires, soils are more likely to erode and resilience is inhibited in part by the toxic aromatic hydrocarbons produced during the combustion of cellulose and lignins. In this study, we explored the use of bioremediation and rhizoremediation techniques for soil restoration in a field-scale trial in a protected Mediterranean ecosystem after a controlled fire. Our bioremediation strategy combined the use of Pseudomonas putida strains, indigenous culturable microbes and annual grasses. After 8 months of monitoring soil quality parameters, including the removal of monoaromatic and polycyclic aromatic hydrocarbons as well as vegetation cover, we found that the site had returned to pre-fire status. Microbial population analysis revealed that fires induced changes in the indigenous microbiota and that rhizoremediation favours the recovery of soil microbiota in time. The results obtained in this study indicate that the rhizoremediation strategy could be presented as a viable and cost-effective alternative for the treatment of ecosystems affected by fires.

  14. Restoration of a Mediterranean forest after a fire: bioremediation and rhizoremediation field-scale trial

    PubMed Central

    Pizarro-Tobías, Paloma; Fernández, Matilde; Niqui, José Luis; Solano, Jennifer; Duque, Estrella; Ramos, Juan-Luis; Roca, Amalia

    2015-01-01

    Forest fires pose a serious threat to countries in the Mediterranean basin, often razing large areas of land each year. After fires, soils are more likely to erode and resilience is inhibited in part by the toxic aromatic hydrocarbons produced during the combustion of cellulose and lignins. In this study, we explored the use of bioremediation and rhizoremediation techniques for soil restoration in a field-scale trial in a protected Mediterranean ecosystem after a controlled fire. Our bioremediation strategy combined the use of Pseudomonas putida strains, indigenous culturable microbes and annual grasses. After 8 months of monitoring soil quality parameters, including the removal of monoaromatic and polycyclic aromatic hydrocarbons as well as vegetation cover, we found that the site had returned to pre-fire status. Microbial population analysis revealed that fires induced changes in the indigenous microbiota and that rhizoremediation favours the recovery of soil microbiota in time. The results obtained in this study indicate that the rhizoremediation strategy could be presented as a viable and cost-effective alternative for the treatment of ecosystems affected by fires. PMID:25079309

  15. Electroacupuncture for Primary Insomnia: A Randomized Controlled Trial

    PubMed Central

    Yeung, Wing-Fai; Chung, Ka-Fai; Zhang, Shi-Ping; Yap, Tuan-Gee; Law, Andrew C.K.

    2009-01-01

    for insomnia. Citation: Yeung WF; Chung KF; Zhang SP; Yap TG; Law ACK. Electroacupuncture for primary insomnia: a randomized controlled trial. SLEEP 2009;32(8):1039-1047. PMID:19725255

  16. Effectiveness of treatment approaches for children and adolescents with reading disabilities: a meta-analysis of randomized controlled trials.

    PubMed

    Galuschka, Katharina; Ise, Elena; Krick, Kathrin; Schulte-Körne, Gerd

    2014-01-01

    Children and adolescents with reading disabilities experience a significant impairment in the acquisition of reading and spelling skills. Given the emotional and academic consequences for children with persistent reading disorders, evidence-based interventions are critically needed. The present meta-analysis extracts the results of all available randomized controlled trials. The aims were to determine the effectiveness of different treatment approaches and the impact of various factors on the efficacy of interventions. The literature search for published randomized-controlled trials comprised an electronic search in the databases ERIC, PsycINFO, PubMed, and Cochrane, and an examination of bibliographical references. To check for unpublished trials, we searched the websites clinicaltrials.com and ProQuest, and contacted experts in the field. Twenty-two randomized controlled trials with a total of 49 comparisons of experimental and control groups could be included. The comparisons evaluated five reading fluency trainings, three phonemic awareness instructions, three reading comprehension trainings, 29 phonics instructions, three auditory trainings, two medical treatments, and four interventions with coloured overlays or lenses. One trial evaluated the effectiveness of sunflower therapy and another investigated the effectiveness of motor exercises. The results revealed that phonics instruction is not only the most frequently investigated treatment approach, but also the only approach whose efficacy on reading and spelling performance in children and adolescents with reading disabilities is statistically confirmed. The mean effect sizes of the remaining treatment approaches did not reach statistical significance. The present meta-analysis demonstrates that severe reading and spelling difficulties can be ameliorated with appropriate treatment. In order to be better able to provide evidence-based interventions to children and adolescent with reading disabilities

  17. Effectiveness of treatment approaches for children and adolescents with reading disabilities: a meta-analysis of randomized controlled trials.

    PubMed

    Galuschka, Katharina; Ise, Elena; Krick, Kathrin; Schulte-Körne, Gerd

    2014-01-01

    Children and adolescents with reading disabilities experience a significant impairment in the acquisition of reading and spelling skills. Given the emotional and academic consequences for children with persistent reading disorders, evidence-based interventions are critically needed. The present meta-analysis extracts the results of all available randomized controlled trials. The aims were to determine the effectiveness of different treatment approaches and the impact of various factors on the efficacy of interventions. The literature search for published randomized-controlled trials comprised an electronic search in the databases ERIC, PsycINFO, PubMed, and Cochrane, and an examination of bibliographical references. To check for unpublished trials, we searched the websites clinicaltrials.com and ProQuest, and contacted experts in the field. Twenty-two randomized controlled trials with a total of 49 comparisons of experimental and control groups could be included. The comparisons evaluated five reading fluency trainings, three phonemic awareness instructions, three reading comprehension trainings, 29 phonics instructions, three auditory trainings, two medical treatments, and four interventions with coloured overlays or lenses. One trial evaluated the effectiveness of sunflower therapy and another investigated the effectiveness of motor exercises. The results revealed that phonics instruction is not only the most frequently investigated treatment approach, but also the only approach whose efficacy on reading and spelling performance in children and adolescents with reading disabilities is statistically confirmed. The mean effect sizes of the remaining treatment approaches did not reach statistical significance. The present meta-analysis demonstrates that severe reading and spelling difficulties can be ameliorated with appropriate treatment. In order to be better able to provide evidence-based interventions to children and adolescent with reading disabilities

  18. Statin tolerability: In defence of placebo-controlled trials

    PubMed Central

    Newman, Connie B

    2015-01-01

    Background Statin intolerance is a barrier to effective lipid-lowering treatment. A significant number of patients stop prescribed statins, or can take only a reduced dose, because of adverse events attributed to the statin, and are then considered statin-intolerant. Methods Examination of differences between statin and placebo in withdrawal rates due to adverse events – a good measure of tolerability – in statin cardiovascular outcome trials in patients with advanced disease and complex medical histories, who may be more vulnerable to adverse effects. The arguments commonly used to dismiss safety and tolerability data in statin clinical trials are examined. Results Rates of withdrawal due to adverse events in trials in patients with advanced disease and complex medical histories are consistently similar in the statin and placebo groups. We find no support for arguments that statin cardiovascular outcome trials do not translate to clinical practice. Conclusions Given the absence of any signal of intolerance in clinical trials, it appears that statin intolerance in the clinic is commonly due to the nocebo effect causing patients to attribute background symptoms to the statin. Consistent with this, over 90% of patients who have stopped treatment because of an adverse event can tolerate a statin if re-challenged. Consequently, new agents, including monoclonal antibodies to proprotein convertase subtilisin/kexin type 9, will be useful when added to statin therapy but should rarely be used as a statin substitute. PMID:26318980

  19. COMBAT: Initial experience with a randomized clinical trial of plasma-based resuscitation in the field for traumatic hemorrhagic shock

    PubMed Central

    Chapman, Michael P.; Moore, Ernest E.; Chin, Theresa L; Ghasabyan, Arsen; Chandler, James; Stringham, John; Gonzalez, Eduardo; Moore, Hunter B.; Banerjee, Anirban; Silliman, Christopher C; Sauaia, Angela

    2015-01-01

    The existing evidence shows great promise for plasma as the first resuscitation fluid in both civilian and military trauma. We embarked on the Control of Major Bleeding After Trauma (COMBAT) trial with the support of the Department of Defense, in order to determine if plasma-first resuscitation yields hemostatic and survival benefits. The methodology of the COMBAT study represents not only three years of development work, but the integration of nearly two-decades of technical experience with the design and implementation of other clinical trials and studies. Herein, we describe the key features of the study design, critical personnel and infrastructural elements, and key innovations. We will also briefly outline the systems engineering challenges entailed by this study. COMBAT is a randomized, placebo controlled, semi-blinded prospective Phase IIB clinical trial, conducted in a ground ambulance fleet based at a Level I trauma center, and part of a multicenter collaboration. The primary objective of COMBAT is to determine the efficacy of field resuscitation with plasma first, compared to standard of care (normal saline). To date we have enrolled 30 subjects in the COMBAT study. The ability to achieve intervention with a hemostatic resuscitation agent in the closest possible temporal proximity to injury is critical and represents an opportunity to forestall the evolution of the “bloody vicious cycle”. Thus, the COMBAT model for deploying plasma in first response units should serve as a model for RCTs of other hemostatic resuscitative agents. PMID:25784527

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

    PubMed Central

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

    2016-01-01

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

  1. Effect of the Mediterranean diet on blood pressure in the PREDIMED trial: results from a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Hypertension can be prevented by adopting healthy dietary patterns. Our aim was to assess the 4-year effect on blood pressure (BP) control of a randomized feeding trial promoting the traditional Mediterranean dietary pattern. Methods The PREDIMED primary prevention trial is a randomized, single-blinded, controlled trial conducted in Spanish primary healthcare centers. We recruited 7,447 men (aged 55 to 80 years) and women (aged 60 to 80 years) who had high risk for cardiovascular disease. Participants were assigned to a control group or to one of two Mediterranean diets. The control group received education on following a low-fat diet, while the groups on Mediterranean diets received nutritional education and also free foods; either extra virgin olive oil, or nuts. Trained personnel measured participants’ BP at baseline and once yearly during a 4-year follow-up. We used generalized estimating equations to assess the differences between groups during the follow-up. Results The percentage of participants with controlled BP increased in all three intervention groups (P-value for within-group changes: P<0.001). Participants allocated to either of the two Mediterranean diet groups had significantly lower diastolic BP than the participants in the control group (−1.53 mmHg (95% confidence interval (CI) −2.01 to −1.04) for the Mediterranean diet supplemented with extra virgin olive oil, and −0.65 mmHg (95% CI -1.15 to −0.15) mmHg for the Mediterranean diet supplemented with nuts). No between-group differences in changes of systolic BP were seen. Conclusions Both the traditional Mediterranean diet and a low-fat diet exerted beneficial effects on BP and could be part of advice to patients for controlling BP. However, we found lower values of diastolic BP in the two groups promoting the Mediterranean diet with extra virgin olive oil or with nuts than in the control group. Trial registration Current Controlled Trials ISRCTN35739639 PMID:24050803

  2. Can user testing of a clinical trial patient information sheet make it fit-for-purpose? - a randomized controlled trial

    PubMed Central

    2011-01-01

    Background The participant information sheet (PIS) provided to potential trial participants is a critical part of the process of valid consent. However, there is long-standing concern that these lengthy and complex documents are not fit-for-purpose. This has been supported recently through the application of a performance-based approach to testing and improving readability called user testing. This method is now widely used to improve patient medicine leaflets - determining whether people can find and understand key facts. This study applied for the first time a controlled design to determine whether a PIS developed through user testing had improved readability over the original, using a sheet from a UK trial in acute myeloid leukemia (AML16). Methods In the first phase the performance of the original PIS was tested on people in the target group for the trial. There were three rounds of testing including 50 people in total - with the information revised according to its performance after each of the first 2 rounds. In the second phase, the revised PIS was compared with the original in a parallel groups randomised controlled trial (RCT) A total of 123 participants were recruited and randomly allocated to read one version of the PIS to find and show understanding of 21 key facts. Results The first, developmental phase produced a revised PIS significantly altered in its wording and layout. In the second, trial phase 66% of participants who read the revised PIS were able to show understanding of all aspects of the trial, compared with 15% of those reading the original version (Odds Ratio 11.2; Chi-square = 31.5 p < .001). When asked to state a preference, 87.1% participants chose the revised PIS (Sign test p < .001). Conclusions The original PIS for the AML16 trial may not have enabled valid consent. Combining performance-based user testing with expertise in writing for patients and information design led to a significantly improved and preferred information sheet

  3. Reporting of Positive Results in Randomized Controlled Trials of Mindfulness-Based Mental Health Interventions

    PubMed Central

    Coronado-Montoya, Stephanie; Levis, Alexander W.; Kwakkenbos, Linda; Steele, Russell J.; Turner, Erick H.; Thombs, Brett D.

    2016-01-01

    Background A large proportion of mindfulness-based therapy trials report statistically significant results, even in the context of very low statistical power. The objective of the present study was to characterize the reporting of “positive” results in randomized controlled trials of mindfulness-based therapy. We also assessed mindfulness-based therapy trial registrations for indications of possible reporting bias and reviewed recent systematic reviews and meta-analyses to determine whether reporting biases were identified. Methods CINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS databases were searched for randomized controlled trials of mindfulness-based therapy. The number of positive trials was described and compared to the number that might be expected if mindfulness-based therapy were similarly effective compared to individual therapy for depression. Trial registries were searched for mindfulness-based therapy registrations. CINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS were also searched for mindfulness-based therapy systematic reviews and meta-analyses. Results 108 (87%) of 124 published trials reported ≥1 positive outcome in the abstract, and 109 (88%) concluded that mindfulness-based therapy was effective, 1.6 times greater than the expected number of positive trials based on effect size d = 0.55 (expected number positive trials = 65.7). Of 21 trial registrations, 13 (62%) remained unpublished 30 months post-trial completion. No trial registrations adequately specified a single primary outcome measure with time of assessment. None of 36 systematic reviews and meta-analyses concluded that effect estimates were overestimated due to reporting biases. Conclusions The proportion of mindfulness-based therapy trials with statistically significant results may overstate what would occur in practice. PMID:27058355

  4. Mean-field sparse optimal control

    PubMed Central

    Fornasier, Massimo; Piccoli, Benedetto; Rossi, Francesco

    2014-01-01

    We introduce the rigorous limit process connecting finite dimensional sparse optimal control problems with ODE constraints, modelling parsimonious interventions on the dynamics of a moving population divided into leaders and followers, to an infinite dimensional optimal control problem with a constraint given by a system of ODE for the leaders coupled with a PDE of Vlasov-type, governing the dynamics of the probability distribution of the followers. In the classical mean-field theory, one studies the behaviour of a large number of small individuals freely interacting with each other, by simplifying the effect of all the other individuals on any given individual by a single averaged effect. In this paper, we address instead the situation where the leaders are actually influenced also by an external policy maker, and we propagate its effect for the number N of followers going to infinity. The technical derivation of the sparse mean-field optimal control is realized by the simultaneous development of the mean-field limit of the equations governing the followers dynamics together with the Γ-limit of the finite dimensional sparse optimal control problems. PMID:25288818

  5. Review of the findings of the Ignik Sikumi CO2-CH4 gas hydrate exchange field trial

    SciTech Connect

    Anderson, Brian J.; Boswell, Ray; Collett, Tim S.; Farrell, Helen; Ohtsuka, Satoshi; White, Mark D.

    2014-08-01

    The Ignik Sikumi Gas Hydrate Exchange Field Trial was conducted by ConocoPhillips in partnership with the U.S. Department of Energy, the Japan Oil, Gas, and Metals National Corporation, and the U.S. Geological Survey within the Prudhoe Bay Unit on the Alaska North Slope (ANS) during 2011 and 2012. The 2011 field program included drilling the vertical test well and performing extensive wireline logging through a thick section of gas-hydrate-bearing sand reservoirs that provided substantial new insight into the nature of ANS gas hydrate occurrences. The 2012 field program involved an extended, scientific field trial conducted within a single vertical well (“huff-and-puff” design) through three primary operational phases: 1) injection of a gaseous phase mixture of CO2, N2, and chemical tracers; 2) flowback conducted at down-hole pressures above the stability threshold for native CH4-hydrate, and 3) extended (30-days) flowback at pressures below the stability threshold of native CH4-hydrate. Ignik Sikumi represents the first field investigation of gas hydrate response to chemical injection, and the longest-duration field reservoir response experiment yet conducted. Full descriptions of the operations and data collected have been fully reported by ConocoPhillips and are available to the science community. The 2011 field program indicated the presence of free water within the gas hydrate reservoir, a finding with significant implications to the design of the exchange trial – most notably the use of a mixed gas injectant. While this decision resulted in a complex chemical environment within the reservoir that greatly tests current experimental and modeling capabilities – without such a mixture, it is apparent that injection could not have been achieved. While interpretation of the field data are continuing, the primary scientific findings and implications of the program are: 1) gas hydrate destabilizing is self-limiting, dispelling any notion of the potential for

  6. The EARN-Health Trial: protocol for a randomised controlled trial to identify health effects of a financial savings programme among low-income US adults

    PubMed Central

    Basu, Sanjay; Hamad, Rita; White, Justin S; Modrek, Sepideh; Rehkopf, David H; Cullen, Mark R

    2015-01-01

    Introduction A theory within the social epidemiology field is that financial stress related to having inadequate financial savings may contribute to psychological stress, poor mental health and poor health-related behaviours among low-income US adults. Our objective is to test whether an intervention that encourages financial savings among low-income US adults improves health behaviours and mental health. Methods and analysis A parallel group two-arm controlled superiority trial will be performed in which 700 participants will be randomised to the intervention or a wait list. The intervention arm will be provided an online Individual Development Account (IDA) for 6 months, during which participants receive a $5 incentive (£3.2, €4.5) for every month they save $20 in their account (£12.8, €18), and an additional $5 if they save $20 for two consecutive months. Both groups will be provided links to standard online financial counselling materials. Online surveys in months 0 (prior to randomisation), 6 and 12 (6 months postintervention) will assess self-reported health behaviours and mental health among participants in both arms. The surveys items were tested previously in the US Centers for Disease Control and Prevention national health interviews and related health studies, including self-reported overall health, health-related quality of life, alcohol and tobacco use, depression symptoms, financial stress, optimism and locus of control, and spending and savings behaviours. Trial data will be analysed on an intent-to-treat basis. Ethics and dissemination This protocol was approved by the Institutional Review Board of Stanford University (Protocol ID: 30641). The findings of the trial will be disseminated through peer-reviewed publication. Trial registration number Identifier NCT02185612; Pre-results. PMID:26443663

  7. Influence of Vitamin E Supplementation on Glycaemic Control: A Meta-Analysis of Randomised Controlled Trials

    PubMed Central

    Xu, Renfan; Zhang, Shasha; Tao, Anyu; Chen, Guangzhi; Zhang, Muxun

    2014-01-01

    Observational studies have revealed that higher serum vitamin E concentrations and increased vitamin E intake and vitamin E supplementation are associated with beneficial effects on glycaemic control in type 2 diabetes mellitus (T2DM). However, whether vitamin E supplementation exerts a definitive effect on glycaemic control remains unclear. This article involves a meta-analysis of randomised controlled trials of vitamin E to better characterise its impact on HbA1c, fasting glucose and fasting insulin. PubMed, EMBASE and the Cochrane Library were electronically searched from the earliest possible date through April 2013 for all relevant studies. Weighted mean difference (WMD) was calculated for net changes using fixed-effects or random-effects models. Standard methods for assessing statistical heterogeneity and publication bias were used. Fourteen randomised controlled trials involving individual data on 714 subjects were collected in this meta-analysis. Increased vitamin E supplementation did not result in significant benefits in glycaemic control as measured by reductions in HbA1c, fasting glucose and fasting insulin. Subgroup analyses revealed a significant reduction in HbA1c (−0.58%, 95% CI −0.83 to −0.34) and fasting insulin (−9.0 pmol/l, 95% CI −15.90 to −2.10) compared with controls in patients with low baseline vitamin E status. Subgroup analyses also demonstrated that the outcomes may have been influenced by the vitamin E dosage, study duration, ethnic group, serum HbA1c concentration, and fasting glucose control status. In conclusion, there is currently insufficient evidence to support a potential beneficial effect of vitamin E supplementation on improvements of HbA1c and fasting glucose and insulin concentrations in subjects with T2DM. PMID:24740143

  8. Randomized Controlled Trial of Transdermal Secretin on Behavior of Children with Autism

    ERIC Educational Resources Information Center

    Ratliff-Schaub, Karen; Carey, Tracy; Reeves, Gretchen; Rogers, Mary

    2005-01-01

    Previous trials of secretin for the treatment of autism have utilized a single or double dose administered intravenously. This is a report of a double-blind, randomized, controlled crossover trial of transdermally applied secretin in 15 children diagnosed with autism or pervasive developmental delay. Secretin or placebo was applied daily, in…

  9. EEG Neurofeedback for ADHD: Double-Blind Sham-Controlled Randomized Pilot Feasibility Trial

    ERIC Educational Resources Information Center

    Arnold, L. Eugene; Lofthouse, Nicholas; Hersch, Sarah; Pan, Xueliang; Hurt, Elizabeth; Bates, Bethany; Kassouf, Kathleen; Moone, Stacey; Grantier, Cara

    2013-01-01

    Objective: Preparing for a definitive randomized clinical trial (RCT) of neurofeedback (NF) for ADHD, this pilot trial explored feasibility of a double-blind, sham-controlled design and adherence/palatability/relative effect of two versus three treatments/week. Method: Unmedicated 6- to 12-year-olds with "Diagnostic and Statistical Manual of…

  10. Sources of Bias in Outcome Assessment in Randomised Controlled Trials: A Case Study

    ERIC Educational Resources Information Center

    Ainsworth, Hannah; Hewitt, Catherine E.; Higgins, Steve; Wiggins, Andy; Torgerson, David J.; Torgerson, Carole J.

    2015-01-01

    Randomised controlled trials (RCTs) can be at risk of bias. Using data from a RCT, we considered the impact of post-randomisation bias. We compared the trial primary outcome, which was administered blindly, with the secondary outcome, which was not administered blindly. From 44 schools, 522 children were randomised to receive a one-to-one maths…

  11. Covariate Adjustment Strategy Increases Power in the Randomized Controlled Trial With Discrete-Time Survival Endpoints

    ERIC Educational Resources Information Center

    Safarkhani, Maryam; Moerbeek, Mirjam

    2013-01-01

    In a randomized controlled trial, a decision needs to be made about the total number of subjects for adequate statistical power. One way to increase the power of a trial is by including a predictive covariate in the model. In this article, the effects of various covariate adjustment strategies on increasing the power is studied for discrete-time…

  12. Effects of Pre-Trial Response Requirements on Self-Control Choices by Rats and Pigeons

    ERIC Educational Resources Information Center

    Mazur, James E.

    2012-01-01

    Parallel experiments with rats and pigeons examined whether the size of a pre-trial ratio requirement would affect choices in a self-control situation. In different conditions, either 1 response or 40 responses were required before each trial. In the first half of each experiment, an adjusting-ratio schedule was used, in which subjects could…

  13. Is an Intervention Using Computer Software Effective in Literacy Learning? A Randomised Controlled Trial

    ERIC Educational Resources Information Center

    Brooks, G.; Miles, J. N. V.; Torgerson, C. J.; Torgerson, D. J.

    2006-01-01

    Background: Computer software is widely used to support literacy learning. There are few randomised trials to support its effectiveness. Therefore, there is an urgent need to rigorously evaluate computer software that supports literacy learning. Methods: We undertook a pragmatic randomised controlled trial among pupils aged 11-12 within a single…

  14. Randomised controlled trial of day patient versus inpatient psychiatric treatment.

    PubMed Central

    Creed, F; Black, D; Anthony, P; Osborn, M; Thomas, P; Tomenson, B

    1990-01-01

    OBJECTIVE--To assess the proportion of acutely ill psychiatric patients who can be treated in a day hospital and compare the outcome of day patient and inpatient treatment. DESIGN--Prospective randomised controlled trial of day patient versus inpatient treatment after exclusion of patients precluded by severity of illness or other factors from being treated as day patients. All three groups assessed at three and 12 months. SETTING--Teaching hospital serving small socially deprived inner city area. Day hospital designed to take acute admissions because of few beds. PATIENTS--175 Patients were considered, of whom 73 could not be allocated. Of the remaining 102 patients, 51 were allocated to each treatment setting but only 89 became established in treatment--namely, 41 day patients and 48 inpatients. 73 Of these 89 patients were reassessed at three months and 70 at one year. INTERVENTIONS--Standard day patient and inpatient treatment. MAIN OUTCOME MEASURES--Discharge from hospital and return to previous level of social functioning; reduction of psychiatric symptoms, abnormal behaviour, and burden on relatives. RESULTS--33 Of 48 inpatients were discharged at three months compared with 17 of 41 day patients. But at one year 9 of 48 inpatients and three of 41 day patients were in hospital. 18 Of 35 day patients and 16 of 39 inpatients were at their previous level of social functioning at one year. The only significant difference at three months was a greater improvement in social role performance in the inpatients. At one year there was no significant difference between day patients and inpatients in present state examination summary scores and social role performance, burden, or behaviour. CONCLUSIONS--Roughly 40% of all acutely ill patients presenting for admission to a psychiatric unit may be treated satisfactorily in a well staffed day hospital. The outcome of treatment is similar to that of inpatient care but might possibly reduce readmissions. The hospital costs

  15. Sham Acupressure Controls Used in Randomized Controlled Trials: A Systematic Review and Critique

    PubMed Central

    Tan, Jing-Yu; Suen, Lorna K. P.; Wang, Tao; Molassiotis, Alexander

    2015-01-01

    Objectives To explore the commonly utilized sham acupressure procedures in existing acupressure trials, and to assess whether different types of sham interventions yield different therapeutic outcomes, and, as far as possible, to identify directions for the future development of an adequate sham acupressure method. Methods Randomized controlled trials comparing true acupressure with sham interventions were included. Thirteen electronic databases were adopted to locate relevant studies from inception to July 3, 2014. Meanwhile, eight Chinese journals on complementary and alternative medicine were manually searched to locate eligible articles. In addition, eligible studies listed in the reference lists of the included papers and other related systematic reviews on acupressure were also screened to further search any potentially eligible trials. Methodological quality of the included studies was evaluated using the risk of bias assessment tool developed by the Cochrane Back Review Group. Descriptive analysis was adopted to summarize the therapeutic outcomes. Results Sixty-six studies with 7265 participants were included. Methodological quality of the included trials was generally satisfactory. Six types of sham acupressure approaches were identified and “non-acupoint” stimulation was the most frequently utilized sham point while an acupressure device was the most commonly used approach for administering sham treatments. Acupressure therapy was a beneficial approach in managing a variety of health problems and the therapeutic effect was found to be more effective in the true acupressure groups than that in the sham comparative groups. No clear association could be identified between different sham acupressure modalities and the reported treatment outcomes. Conclusions A great diversity of sham acupressure controls have been used in clinical practice and research. A solid conclusion whether different sham alternatives are related to different treatment outcomes

  16. Creation and implementation of a historical controls database from randomized clinical trials

    PubMed Central

    Desai, Jigar R; Bowen, Edward A; Danielson, Mark M; Allam, Rajasekhar R; Cantor, Michael N

    2013-01-01

    Background Ethical concerns about randomly assigning patients to suboptimal or placebo arms and the paucity of willing participants for randomization into control and experimental groups have renewed focus on the use of historical controls in clinical trials. Although databases of historical controls have been advocated, no published reports have described the technical and informatics issues involved in their creation. Objective To create a historical controls database by leveraging internal clinical trial data at Pfizer, focusing on patients who received only placebo in randomized controlled trials. Methods We transformed disparate clinical data sources by indexing, developing, and integrating clinical data within internal databases and archives. We focused primarily on trials mapped into a consistent standard and trials in the pain therapeutic area as a pilot. Results Of the more than 20 000 internal Pfizer clinical trials, 2404 completed placebo controlled studies with a parallel design were identified. Due to challenges with informed consent and data standards used in older clinical trials, studies completed before 2000 were excluded, yielding 1134 studies from which placebo subjects and associated clinical data were extracted. Conclusions It is technically feasible to pool portions of placebo populations through a stratification and segmentation approach for a historical placebo group database. A sufficiently large placebo controls database would enable previous distribution calculations on representative populations to supplement, not eliminate, the placebo arm of future clinical trials. Creation of an industry-wide placebo controls database, utilizing a universal standard, beyond the borders of Pfizer would add significant efficiencies to the clinical trial and drug development process. PMID:23449762

  17. Controlling Casimir force via coherent driving field

    NASA Astrophysics Data System (ADS)

    Ahmad, Rashid; Abbas, Muqaddar; Ahmad, Iftikhar; Qamar, Sajid

    2016-04-01

    A four level atom-field configuration is used to investigate the coherent control of Casimir force between two identical plates made up of chiral atomic media and separated by vacuum of width d. The electromagnetic chirality-induced negative refraction is obtained via atomic coherence. The behavior of Casimir force is investigated using Casimir-Lifshitz formula. It is noticed that Casimir force can be switched from repulsive to attractive and vice versa via coherent control of the driving field. This switching feature provides new possibilities of using the repulsive Casimir force in the development of new emerging technologies, such as, micro-electro-mechanical and nano-electro-mechanical systems, i.e., MEMS and NEMS, respectively.

  18. Beyond Randomized Controlled Trials in Attempted Suicide Research

    ERIC Educational Resources Information Center

    Hatcher, Simon; Sharon, Cynthia; Coggan, Carol

    2009-01-01

    There is a lack of evidence about what is the best treatment for people who present to hospital after self harm. Most treatment trials have been small and involved unrepresentative groups of patients which result in inconclusive findings. Here we note some of the characteristics of attempted suicide which make it a difficult subject to study. We…

  19. Visibility aids for pedestrians and cyclists: a systematic review of randomised controlled trials.

    PubMed

    Kwan, Irene; Mapstone, James

    2004-05-01

    This study aims to quantify the effect of visibility aids on the occurrence of pedestrian and cyclist-motor vehicle collisions and injuries, and drivers' responses in detection and recognition. Trial reports were systematically reviewed according to predefined eligibility criteria, including randomised controlled trials or controlled before-and-after trials comparing visibility aids and no visibility aids, and of different visibility aids on pedestrian and cyclist safety, and drivers' responses in detection and recognition. This included trials in which the order of interventions was randomised, or balanced using a Latin square design. Two reviewers independently assessed validity of trials and abstracted data. The main outcome measures were pedestrian and cyclist-motor vehicle collisions and injuries, and drivers'/observers' responses in the detection and recognition time, distance and frequency. No trials which assessed the effect of visibility aids on pedestrian and cyclist-motor vehicle collisions and injuries were identified. Twelve trials examined the effectiveness of daytime visibility aids and 25 trials on night time visibility aids, including 882 participants. Drivers' and observers' detection and recognition improved with visibility aids. For daytime, fluorescent materials in yellow, red and orange colours enhanced detection and recognition. "Biomotion" markings enhanced recognition. Substantial heterogeneity between the trials limits the possibility for meta-analysis. Visibility aids have the potential to improve detection and recognition and would merit further development to gain public acceptance. However, the impact of visibility aids on pedestrian and cyclist safety is unknown and needs to be determined. PMID:15003574

  20. Observational Assessment Of Field Trial Site For The Implementation Of A PACS Network

    NASA Astrophysics Data System (ADS)

    Coristine, Marjorie A.; Tombaugh, Jo W.; Dillon, Richard F.

    1989-05-01

    In building an integrated radiological information system (IRIS) and preparing for field trials at a large hospital, it was necessary to consider the working conventions and needs of radiologists and clinicians. It was also necessary to analyse the current practices involved in the requesting, reading, and reporting of x-rays. Because IRIS is designed to be a mechanism for effective consultations, an understanding of the conventions and nature of x-ray related consultations was also needed. In order to gain this understanding, two observational studies were conducted. The first addressed issues of x-ray related behavior in the emergency department, and the second assessed the task requirements of radiologists when reporting x-rays or consulting with other physicians about x-rays. These findings had major implications for the design of IRIS and for conducting the field trials.

  1. Safety and immunogenicity of the synthetic malaria vaccine SPf66 in a large field trial.

    PubMed

    Amador, R; Moreno, A; Murillo, L A; Sierra, O; Saavedra, D; Rojas, M; Mora, A L; Rocha, C L; Alvarado, F; Falla, J C

    1992-07-01

    In the first field trial with synthetic malaria vaccine SPf66 in a large population naturally exposed to malaria, 9957 persons greater than 1 year old and residing on the Colombian Pacific coast received three doses of the vaccine. To evaluate vaccine safety, clinical observations were made 30 min and 48 h after each immunization. There were no adverse reactions in 95.7% of cases. In the 4.3% of cases with adverse reactions, local induration and erythema were the most frequent. In a randomly selected group of vaccinees, anti-SPf66 antibody titers were measured after the third dose: 93% of the vaccinees raised antibodies to SPf66. Among these, 55% had titers greater than 1:1600. These results demonstrate the safety and immunogenicity of the SPf66 vaccine in a large field trial.

  2. Randomized controlled trials in relapsed/refractory follicular lymphoma: a systematic review and meta-analysis.

    PubMed

    Police, Rachel L; Trask, Peter C; Wang, Jianmin; Olivares, Robert; Khan, Shahnaz; Abbe, Adeline; Colosia, Ann; Njue, Annete; Sherril, Beth; Ruiz-Soto, Rodrigo; Kaye, James A; Hamadani, Mehdi

    2016-10-01

    This systematic literature review evaluated the clinical efficacy and safety of interventions used in relapsed/refractory follicular lymphoma. Primary efficacy outcomes were objective response rate, progression-free survival and overall survival. Safety endpoints were grade 3/4 toxicities, serious adverse events and withdrawals or deaths due to toxicity. Studies were selected if they were randomized controlled trials reporting on the efficacy or safety of treatments for relapsed or refractory follicular lymphoma, and if outcomes were reported separately from trials that included other lymphoid neoplasms. We used the Bucher method for conducting adjusted indirect comparisons within a meta-analysis. We identified 10 randomized controlled trials of treatments for relapsed/refractory follicular lymphoma. The most prominent drug investigated (alone or in combination) was rituximab. Most trials did not report median overall survival. Two trials reported median event-free survival (range, 1.2-23.2 months). Six of ten trials reported objective response rate (range, 9-93%). Meta-analysis showed only one statistically significant result: rituximab + bortezomib yielded a significantly higher objective response rate than rituximab monotherapy (relative risk, 1.28; 95% confidence interval, 1.11-1.47). Otherwise, there were no discernable differences in overall survival or progression-free survival, partly due to insufficient reporting of results in the clinical trials. The relatively small number of randomized controlled trials, few overlapping treatment arms, and variability in the randomized controlled trial features and in the endpoints studied complicate the formal comparison of therapies for relapsed/refractory follicular lymphoma. Additional well-designed randomized controlled trials are needed to fully understand the relative outcomes of older and more recently developed therapies. PMID:26320127

  3. Results from field trial of a low-cost solar cooker with novel concentrator geometry

    NASA Astrophysics Data System (ADS)

    Berryman, Ian; Jelley, Nick; Stone, Richard; Dadd, Mike

    2016-05-01

    Solar cookers are generally of either box-type or make use of parabolic dishes, including approximations thereof. The former are cheap but operate at low solar concentrations and temperatures, whilst the latter often require complex mirror geometries and can be prohibitively expensive to manufacture. This paper will present the results from a field trial of a prototype solar cooker which use of a novel concentrator geometry to achieve high temperatures.

  4. Ringing Up about Breastfeeding: a randomised controlled trial exploring early telephone peer support for breastfeeding (RUBY) – trial protocol

    PubMed Central

    2014-01-01

    Background The risks of not breastfeeding for mother and infant are well established, yet in Australia, although most women initiate breastfeeding many discontinue breastfeeding altogether and few women exclusively breastfeed to six months as recommended by the World Health Organization and Australian health authorities. We aim to determine whether proactive telephone peer support during the postnatal period increases the proportion of infants who are breastfed at six months, replicating a trial previously found to be effective in Canada. Design/Methods A two arm randomised controlled trial will be conducted, recruiting primiparous women who have recently given birth to a live baby, are proficient in English and are breastfeeding or intending to breastfeed. Women will be recruited in the postnatal wards of three hospitals in Melbourne, Australia and will be randomised to peer support or to ‘usual’ care. All women recruited to the trial will receive usual hospital postnatal care and infant feeding support. For the intervention group, peers will make two telephone calls within the first ten days postpartum, then weekly telephone calls until week twelve, with continued contact until six months postpartum. Primary aim: to determine whether postnatal telephone peer support increases the proportion of infants who are breastfed for at least six months. Hypothesis: that telephone peer support in the postnatal period will increase the proportion of infants receiving any breast milk at six months by 10% compared with usual care (from 46% to 56%). Outcome data will be analysed by intention to treat. A supplementary multivariate analysis will be undertaken if there are any baseline differences in the characteristics of women in the two groups which might be associated with the primary outcomes. Discussion The costs and health burdens of not breastfeeding fall disproportionately and increasingly on disadvantaged groups. We have therefore deliberately chosen trial sites

  5. International collaborative trials, placebo controls and The Declaration of Helsinki: need for clarification in paragraph 32.

    PubMed

    Malik, A Y; Ghafoor, F

    2012-01-01

    Inequities in socio-economic and healthcare systems between developed and developing countries have been thrown into sharp relief by globalisation. At the same time, pharmaceutical companies have started conducting clinical trials in developing countries in order to reduce their costs substantially. Together, these two developments create ethical challenges for sponsors and researchers of these trials. One such challenge is that of placebo-controlled trials (PCTs). In this paper we analyse Paragraph 32 of the Declaration of Helsinki referring to PCTs, identifying ambiguities in the wording, and then examine three arguments presented by sponsors of PCTs in developing countries, in defence of such trials. These arguments are: (i) a placebo control provides a definitive answer, and is therefore methodologically superior; (ii) placebo-controlled trials are ethical because they serve the principle of utility, and (iii) interpreting the "best current proven intervention" as the local standard of care allows PCTs to be conducted, if the local standard of care is "no treatment". We argue that PCTs are not methodologically superior; nor are they ethically defensible. Other trial designs conforming to the ethics of research are feasible; the reason for conducting PCTs is expediency. We further propose that, given the global applicability of the Declaration of Helsinki, it is imperative to remove the ambiguities in Paragraph 32. In the context of collaborative trials, when a treatment exists, conducting PCTs is ethically unacceptable, irrespective of the geographic location of the trial. Universal standards ought to be applied universally. PMID:22319846

  6. International collaborative trials, placebo controls and The Declaration of Helsinki: need for clarification in paragraph 32.

    PubMed

    Malik, A Y; Ghafoor, F

    2012-01-01

    Inequities in socio-economic and healthcare systems between developed and developing countries have been thrown into sharp relief by globalisation. At the same time, pharmaceutical companies have started conducting clinical trials in developing countries in order to reduce their costs substantially. Together, these two developments create ethical challenges for sponsors and researchers of these trials. One such challenge is that of placebo-controlled trials (PCTs). In this paper we analyse Paragraph 32 of the Declaration of Helsinki referring to PCTs, identifying ambiguities in the wording, and then examine three arguments presented by sponsors of PCTs in developing countries, in defence of such trials. These arguments are: (i) a placebo control provides a definitive answer, and is therefore methodologically superior; (ii) placebo-controlled trials are ethical because they serve the principle of utility, and (iii) interpreting the "best current proven intervention" as the local standard of care allows PCTs to be conducted, if the local standard of care is "no treatment". We argue that PCTs are not methodologically superior; nor are they ethically defensible. Other trial designs conforming to the ethics of research are feasible; the reason for conducting PCTs is expediency. We further propose that, given the global applicability of the Declaration of Helsinki, it is imperative to remove the ambiguities in Paragraph 32. In the context of collaborative trials, when a treatment exists, conducting PCTs is ethically unacceptable, irrespective of the geographic location of the trial. Universal standards ought to be applied universally.

  7. Vouchers versus Lotteries: What works best in promoting Chlamydia screening? A cluster randomised controlled trial

    PubMed Central

    Niza, Claudia; Rudisill, Caroline; Dolan, Paul

    2014-01-01

    In this cluster randomised trial (N=1060), we tested the impact of financial incentives (£5 voucher vs. £200 lottery) framed as a gain or loss to promote Chlamydia screening in students aged 18–24 years, mimicking the standard outreach approach to student in halls of residence. Compared to the control group (1.5%), the lottery increased screening to 2.8% and the voucher increased screening to 22.8%. Incentives framed as gains were marginally more effective (10.5%) that loss-framed incentives (7.1%). This work fundamentally contributes to the literature by testing the predictive validity of Prospect Theory to change health behaviour in the field. PMID:25061507

  8. Balancing ballistic protection against physiological strain: evidence from laboratory and field trials.

    PubMed

    Taylor, Nigel A S; Burdon, Catriona A; van den Heuvel, Anne M J; Fogarty, Alison L; Notley, Sean R; Hunt, Andrew P; Billing, Daniel C; Drain, Jace R; Silk, Aaron J; Patterson, Mark J; Peoples, Gregory E

    2016-02-01

    This project was based on the premise that decisions concerning the ballistic protection provided to defence personnel should derive from an evaluation of the balance between protection level and its impact on physiological function, mobility, and operational capability. Civilians and soldiers participated in laboratory- and field-based studies in which ensembles providing five levels of ballistic protection were evaluated, each with progressive increases in protection, mass (3.4-11.0 kg), and surface-area coverage (0.25-0.52 m(2)). Physiological trials were conducted on volunteers (N = 8) in a laboratory, under hot-dry conditions simulating an urban patrol: walking at 4 km·h(-1) (90 min) and 6 km·h(-1) (30 min or to fatigue). Field-based trials were used to evaluate tactical battlefield movements (mobility) of soldiers (N = 31) under tropical conditions, and across functional tests of power, speed, agility, endurance, and balance. Finally, trials were conducted at a jungle training centre, with soldiers (N = 32) patrolling under tropical conditions (averaging 5 h). In the laboratory, work tolerance was reduced as protection increased, with deep-body temperature climbing relentlessly. However, the protective ensembles could be grouped into two equally stressful categories, each providing a different level of ballistic protection. This outcome was supported during the mobility trials, with the greatest performance decrement evident during fire and movement simulations, as the ensemble mass was increased (-2.12%·kg(-1)). The jungle patrol trials similarly supported this outcome. Therefore, although ballistic protection does increase physiological strain, this research has provided a basis on which to determine how that strain can be balanced against the mission-specific level of required personal protection.

  9. Protocol for the Locomotor Experience Applied Post-stroke (LEAPS) trial: a randomized controlled trial

    PubMed Central

    Duncan, Pamela W; Sullivan, Katherine J; Behrman, Andrea L; Azen, Stanley P; Wu, Samuel S; Nadeau, Stephen E; Dobkin, Bruce H; Rose, Dorian K; Tilson, Julie K

    2007-01-01

    Background Locomotor training using body weight support and a treadmill as a therapeutic modality for rehabilitation of walking post-stroke is being rapidly adopted into clinical practice. There is an urgent need for a well-designed trial to determine the effectiveness of this intervention. The objective of the Locomotor Experience Applied Post-Stroke (LEAPS) trial is to determine if there is a difference in the proportion of participants who recover walking ability at one year post-stroke when randomized to a specialized locomotor training program (LTP), conducted at 2- or 6-months post-stroke, or those randomized to a home based non-specific, low intensity exercise intervention (HEP) provided 2 months post-stroke. We will determine if the timing of LTP delivery affects gait speed at 1 year and whether initial impairment severity interacts with the timing of LTP. The effect of number of treatment sessions will be determined by changes in gait speed taken pre-treatment and post-12, -24, and -36 sessions. Methods/Design We will recruit 400 adults with moderate or severe walking limitations within 30 days of stroke onset. At two months post stroke, participants are stratified by locomotor impairment severity as determined by overground walking speed and randomly assigned to one of three groups: (a) LTP-Early; (b) LTP-Late or (c) Home Exercise Program -Early. The LTP program includes body weight support on a treadmill and overground training. The LTP and HEP interventions are delivered for 36 sessions over 12 weeks. Primary outcome measure include successful walking recovery defined as the achievement of a 0.4 m/s gait speed or greater by persons with initial severe gait impairment or the achievement of a 0.8 m/s gait speed or greater by persons with initial moderate gait impairment. LEAPS is powered to detect a 20% difference in the proportion of participants achieving successful locomotor recovery between the LTP groups and the HEP group, and a 0.1 m/s mean

  10. Field-Oriented Control Of Induction Motors

    NASA Technical Reports Server (NTRS)

    Burrows, Linda M.; Roth, Mary Ellen; Zinger, Don S.

    1993-01-01

    Field-oriented control system provides for feedback control of torque or speed or both. Developed for use with commercial three-phase, 400-Hz, 208-V, 5-hp motor. Systems include resonant power supply operating at 20 kHz. Pulse-population-modulation subsystem selects individual pulses of 20-kHz single-phase waveform as needed to synthesize three waveforms of appropriate lower frequency applied to three phase windings of motor. Electric actuation systems using technology currently being built to peak powers of 70 kW. Amplitude of voltage of effective machine-frequency waveform determined by momentary frequency of pulses, while machine frequency determined by rate of repetition of overall temporal pattern of pulses. System enables independent control of both voltage and frequency.

  11. Controlled trial of azathioprine in treatment of steroid-responsive nephrotic syndrome of childhood.

    PubMed Central

    Barratt, T M; Cameron, J S; Chantler, C; Counahan, R; Ogg, C S; Soothill, J F

    1977-01-01

    A controlled trial of azathioprine treatment of steroid-responsive frequent-relapsing nephrotic syndrome of childhood failed to show a therapeutic effect on the stability of remission after withdrawal of corticosteroid treatment. PMID:879831

  12. Field oriented control of induction motors

    NASA Technical Reports Server (NTRS)

    Burrows, Linda M.; Zinger, Don S.; Roth, Mary Ellen

    1990-01-01

    Induction motors have always been known for their simple rugged construction, but until lately were not suitable for variable speed or servo drives due to the inherent complexity of the controls. With the advent of field oriented control (FOC), however, the induction motor has become an attractive option for these types of drive systems. An FOC system which utilizes the pulse population modulation method to synthesize the motor drive frequencies is examined. This system allows for a variable voltage to frequency ratio and enables the user to have independent control of both the speed and torque of an induction motor. A second generation of the control boards were developed and tested with the next point of focus being the minimization of the size and complexity of these controls. Many options were considered with the best approach being the use of a digital signal processor (DSP) due to its inherent ability to quickly evaluate control algorithms. The present test results of the system and the status of the optimization process using a DSP are discussed.

  13. Herbal medicine, randomised controlled trials and global core competencies.

    PubMed

    Siegfried, Nandi Louise; Hughes, Gail

    2012-12-01

    Despite widespread use, few empirical data on the efficacy of traditional medicine are available. We conducted systematic reviews of eight widely used African medicines and identified only one plant, Pelargonium sidoides, which has been extensively studied (including in a Cochrane systematic review). To address the need for rigorous science to underpin traditional medicine claims, the South African Herbal Science and Medicine Institute at the University of Western Cape launched the Multi-disciplinary University Traditional Health Initiative (MUTHI) in 2011. The European Union-funded initiative aims to build sustainable research capacity on plants for better public health in Africa. A 2011 needs analysis of clinicians and scientists from 14 African countries confirmed a lack of clinical trial methodology, knowledge and experience. In response, MUTHI deliverables include annual clinical trial methodology workshops in host countries and development of e-learning modules. The initiative provides a unique opportunity for developing African capacity to discover new medicinal products. PMID:23498035

  14. A controlled trial of amitriptyline and cianopramine in major depression.

    PubMed

    Mellsop, G W; Burgess, C D; Vijayasenan, M E

    1985-01-01

    The therapeutic efficacy and adverse effects of amitriptyline and cianopramine were compared in a double-blind, randomized, flexible-dose trial in 40 patients with major depressive episodes. The two drugs were equally effective in reducing scores on the Hamilton Psychiatric Rating Scale for Depression and on a global scale. Both drugs were associated with significant adverse effects. Fewer adverse effects were associated with cianopramine, however, which lacks antimuscarinic activity.

  15. Quality control for digital mammography: Part II recommendations from the ACRIN DMIST trial

    SciTech Connect

    Yaffe, Martin J.; Bloomquist, Aili K.; Mawdsley, Gordon E.

    2006-03-15

    The Digital Mammography Imaging Screening Trial (DMIST), conducted under the auspices of the American College of Radiology Imaging Network (ACRIN), is a clinical trial designed to compare the accuracy of digital versus screen-film mammography in a screening population [E. Pisano et al., ACRIN 6652--Digital vs. Screen-Film Mammography, ACRIN (2001)]. Part I of this work described the Quality Control program developed to ensure consistency and optimal operation of the digital equipment. For many of the tests, there were no failures during the 24 months imaging was performed in DMIST. When systems failed, they generally did so suddenly rather than through gradual deterioration of performance. In this part, the utility and effectiveness of those tests are considered. This suggests that after verification of proper operation, routine extensive testing would be of minimal value. A recommended set of tests is presented including additional and improved tests, which we believe meet the intent and spirit of the Mammography Quality Standards Act regulations to ensure that full-field digital mammography systems are functioning correctly, and consistently producing mammograms of excellent image quality.

  16. Field trial for reducing porcine Taenia solium cysticercosis in Mexico by systematic vaccination of pigs.

    PubMed

    Molinari, J L; Rodríguez, D; Tato, P; Soto, R; Arechavaleta, F; Solano, S

    1997-04-01

    It has previously been demonstrated that immunization of pigs with a crude extract of Taenia solium metacestodes can confer a high level of protection against an egg challenge. Furthermore, vaccination of infected animals also induces an immune response against the larvae, which are either destroyed or rendered non-infectious. To assess the efficacy of immunization as a strategy for reducing the prevalence of porcine cysticercosis, a field trial of this vaccine was performed in an endemic area in the northern region of the Guerrero State, Mexico, Random samples of pigs belonging to 17 villages were examined for metacestodes by inspection of their tongues. Each animal was immunized with a dose of 150 micrograms of protein (antigenic extract from Taenia solium metacestodes) by the intramuscular route. A prevalence of 2.4% of porcine cysticercosis on average was found in these villages at the beginning of the trial (62 cysticercotic pigs out of 2650 inspected). Six of these villages were selected for the periodic vaccination of new random samples of pigs. A statistically significant decline in the prevalence of porcine cysticercosis was observed at the end of the trial, decreasing from 2.4% at the beginning of vaccination to 0.45% at the end of the trial. A reduction of 82% was observed in spite of the poor living conditions in these villages. These results are consistent with previous data and suggest that it may be possible to turn a susceptible pig population into a protected one by systematic vaccination.

  17. Simulation of plume dispersion from single release in Fusion Field Trial-07 experiment

    NASA Astrophysics Data System (ADS)

    Singh, Sarvesh Kumar; Sharan, Maithili

    2013-12-01

    Accurate description of source-receptor relationship is required for an efficient source reconstruction. This is examined by simulating the dispersion of plumes resulted from the available ten trials of single releases conducted at Fusion Field Trials, Dugway Proving Ground, Utah. The simulation is addressed with an earlier developed IIT (Indian Institute of Technology) dispersion model using the dispersion parameters in terms of measurements of turbulent velocity fluctuations. Simulation is described separately in both stable and unstable conditions, characterizing the peak as well as overall observed concentration distribution. Simulated results are compared with those obtained using AERMOD. With IIT model, peak concentrations are predicted within a factor of two in all the trials. The higher concentrations (>5 × 10-4 g m-3) are well predicted in stable condition and under-predicted (within a factor of two) in unstable condition whereas relatively smaller concentrations (<5 × 10-4 g m-3) are severely under-predicted in stable conditions and over-predicted in unstable conditions. The AERMOD exhibits the similar prediction of concentrations as shown by IIT model in most of the trials. Overall, both the models predict 70-80% concentrations in stable conditions and 85-95% concentrations in unstable conditions within a factor of six. The statistical measures for both the models are found well in agreement with the observations.

  18. Laboratory and field trials of Coriolis mass flow metering for three-phase flow measurement

    NASA Astrophysics Data System (ADS)

    Zhou, Feibiao; Henry, Manus; Tombs, Michael

    2014-04-01

    A new three-phase flow metering technology is discussed in this paper, which combines Coriolis mass flow and water cut readings and without applying any phase separation [1]. The system has undergone formal laboratory trials at TUV NEL (National Engineering Laboratory), UK and at VNIIR (National Flow Laboratory), Kazan, Russia; a number of field trials have taken place in Russia. Laboratory trial results from the TUV NEL will be described in detail. For the 50mm (2") metering system, the total liquid flow rate ranged from 2.4 kg/s up to 11 kg/s, the water cut ranged from 0% to 100%, and the gas volume fraction (GVF) from 0 to 50%. In a formally observed trial, 75 test points were taken at a temperature of approximately 40 °C and with a skid inlet pressure of approximately 350 kPa. Over 95% of the test results fell within the desired specification, defined as follows: the total (oil + water) liquid mass flow error should fall within ± 2.5%, and the gas mass flow error within ± 5.0%. The oil mass flow error limit is ± 6.0% for water cuts less than 70%, while for water cuts between 70% and 95% the oil mass flow error limit is ± 15.0%. These results demonstrate the potential for using Coriolis mass flow metering combined with water cut metering for three-phase (oil/water/gas) measurement.

  19. Entry control technology biometric field evaluations

    SciTech Connect

    Rodriguez, J.R.; Ahrens, J.S.; Lowe, D.L.

    1995-07-01

    Throughout the years, Sandia National Laboratories (SNL) has performed various laboratory evaluations of entry control devices, including biometric identity verifiers. The reports which resulted from this testing have been very well received by the physical security community. This same community now requires equally informative field study data. To meet this need we have conducted a field study in an effort to develop the tools and methods which our customers can use to translate laboratory data into operational field performance. The field testing described in this report was based on the Recognition Systems Inc.`s (RSI) model ID3D HandKey biometric verifier. This device was selected because it is referenced in DOE documents such as the Guide for Implementation of the DOE Standard Badge and is the de facto biometric standard for the DOE. The ID3D HandKey is currently being used at several DOE sites such as Hanford, Rocky Flats, Pantex, Savannah River, and Idaho Nuclear Engineering Laboratory. The ID3D HandKey was laboratory tested at SNL. It performed very well during this test, exhibiting an equal error point of 0.2 percent. The goals of the field test were to identify operational characteristics and design guidelines to help system engineers translate laboratory data into field performance. A secondary goal was to develop tools which could be used by others to evaluate system effectiveness or improve the performance of their systems. Operational characteristics were determined by installing a working system and studying its operation over a five month period. Throughout this test we developed tools which could be used by others to similarly gauge system effectiveness.

  20. Efficacy of a piglet-specific commercial inactivated vaccine against Porcine circovirus type 2 in clinical field trials

    PubMed Central

    Han, Kiwon; Seo, Hwi Won; Oh, Yeonsu; Park, Changhoon; Kang, Ikjae; Jang, Hyun; Chae, Chanhee

    2013-01-01

    The efficacy of a piglet-specific inactivated Porcine circovirus type 2 (PCV2) vaccine was evaluated with clinical field trials, as recommended by the Republic of Korea’s Animal, Plant & Fisheries Quarantine & Inspection Agency. Three farms were selected on the basis of their history of postweaning multisystemic wasting syndrome. On each farm 60, 1-week-old pigs were randomly allocated to 1 of 2 treatment groups: vaccination at 1 and 3 wk of age or no vaccination. The 2-dose schedule of vaccination with inactivated PCV2 vaccine improved the average daily weight gain from birth to 16 wk of age, the PCV2 load in the blood, and the frequency and severity of lymph node lesions. Inactivated PCV2 vaccine seems to be very effective in controlling PCV2 infection under field conditions. PMID:24101803

  1. Systematic review of clinical trials of cervical manipulation: control group procedures and pain outcomes

    PubMed Central

    2011-01-01

    Objective To characterize the types of control procedures used in controlled clinical trials of cervical spine manipulation and to evaluate the outcomes obtained by subjects in control groups so as to improve the quality of future clinical trials Methods A search of relevant clinical trials was performed in PubMed 1966-May 2010 with the following key words: "Chiropractic"[Mesh] OR "Manipulation, Spinal"[Mesh]) AND "Clinical Trial "[Publication Type]. Reference lists from these trials were searched for any additional trials. The reference lists of two prior studies, one review and one original study were also searched. Accepted reports were then rated for quality by 2 reviewers using the PEDro scale. Studies achieving a score of >50% were included for data extraction and analysis. Intra-group change scores on pain outcomes were obtained. For determining clinically important outcomes, a threshold of 20% improvement was used where continuous data were available; otherwise, an effect size of 0.30 was employed Results The PubMed search yielded 753 citations of which 13 were selected. Eight (8) other studies were identified by reviewing two systematic reviews and through reference searches. All studies scored >50% on the PEDro scale. There were 9 multi-session studies and 12 single-session studies. The most commonly used control procedure was "manual contact/no thrust". Four (4) studies used a placebo-control (patient blinded). For two of these studies with VAS data, the average change reported was 4.5 mm. For the other control procedures, variable results were obtained. No clinically important changes were reported in 57% of the paired comparisons, while, in 43% of these, changes which would be considered clinically important were obtained in the control groups. Only 15% of trials reported on post-intervention group registration. Conclusions Most control procedures in cervical manipulation trials result in small clinical changes, although larger changes are observed in

  2. Is fresh frozen plasma clinically effective? A systematic review of randomized controlled trials.

    PubMed

    Stanworth, S J; Brunskill, S J; Hyde, C J; McClelland, D B L; Murphy, M F

    2004-07-01

    Summary Randomized controlled trials of good quality are a recognized means to robustly assess the efficacy of interventions in clinical practice. A systematic identification and appraisal of all randomized trials involving fresh frozen plasma (FFP) has been undertaken in parallel to the drafting of the updated British Committee for Standards in Haematology guidelines on the use of FFP. A total of 57 trials met the criteria for inclusion in the review. Most clinical uses of FFP, currently recommended by practice guidelines, are not supported by evidence from randomized trials. In particular, there is little evidence for the effectiveness of the prophylactic use of FFP. Many published trials on the use of FFP have enrolled small numbers of patients, and provided inadequate information on the ability of the trial to detect meaningful differences in outcomes between the two patient groups. Other concerns about the design of the trials include the dose of FFP used, and the potential for bias. No studies have taken adequate account of the extent to which adverse effects might negate the clinical benefits of treatment with FFP. There is a need to consider how best to develop new trials to determine the efficacy of FFP in different clinical scenarios to provide the evidence base to support national guidelines for transfusion practice. Trials of modified FFP (e.g. pathogen inactivated) are of questionable value when there is little evidence that the standard product is an effective treatment. PMID:15198745

  3. Getting added value from using qualitative research with randomized controlled trials: a qualitative interview study

    PubMed Central

    2014-01-01

    Background Qualitative research is undertaken with randomized controlled trials of health interventions. Our aim was to explore the perceptions of researchers with experience of this endeavour to understand the added value of qualitative research to the trial in practice. Methods A telephone semi-structured interview study with 18 researchers with experience of undertaking the trial and/or the qualitative research. Results Interviewees described the added value of qualitative research for the trial, explaining how it solved problems at the pretrial stage, explained findings, and helped to increase the utility of the evidence generated by the trial. From the interviews, we identified three models of relationship of the qualitative research to the trial. In ‘the peripheral’ model, the trial was an opportunity to undertake qualitative research, with no intention that it would add value to the trial. In ‘the add-on’ model, the qualitative researcher understood the potential value of the qualitative research but it was viewed as a separate and complementary endeavour by the trial lead investigator and wider team. Interviewees described how this could limit the value of the qualitative research to the trial. Finally ‘the integral’ model played out in two ways. In ‘integral-in-theory’ studies, the lead investigator viewed the qualitative research as essential to the trial. However, in practice the qualitative research was under-resourced relative to the trial, potentially limiting its ability to add value to the trial. In ‘integral-in-practice’ studies, interviewees described how the qualitative research was planned from the beginning of the study, senior qualitative expertise was on the team from beginning to end, and staff and time were dedicated to the qualitative research. In these studies interviewees described the qualitative research adding value to the trial although this value was not necessarily visible beyond the original research team due

  4. A pilot test of the new Swiss regulatory procedure for categorizing clinical trials by risk: A randomized controlled trial

    PubMed Central

    Cevallos, Myriam; Züllig, Stephanie; Christen, Andri; Meier, Brigitte E; Goetz, Martin; Coslovsky, Michael; Trelle, Sven

    2015-01-01

    Background/Aims: Several countries are working to adapt clinical trial regulations to align the approval process to the level of risk for trial participants. The optimal framework to categorize clinical trials according to risk remains unclear, however. Switzerland is the first European country to adopt a risk-based categorization procedure in January 2014. We assessed how accurately and consistently clinical trials are categorized using two different approaches: an approach using criteria set forth in the new law (concept) or an intuitive approach (ad hoc). Methods: This was a randomized controlled trial with a method-comparison study nested in each arm. We used clinical trial protocols from eight Swiss ethics committees approved between 2010 and 2011. Protocols were randomly assigned to be categorized in one of three risk categories using the concept or the ad hoc approach. Each protocol was independently categorized by the trial’s sponsor, a group of experts and the approving ethics committee. The primary outcome was the difference in categorization agreement between the expert group and sponsors across arms. Linear weighted kappa was used to quantify agreements, with the difference between kappas being the primary effect measure. Results: We included 142 of 231 protocols in the final analysis (concept = 78; ad hoc = 64). Raw agreement between the expert group and sponsors was 0.74 in the concept and 0.78 in the ad hoc arm. Chance-corrected agreement was higher in the ad hoc (kappa: 0.34 (95% confidence interval = 0.10–0.58)) than in the concept arm (0.27 (0.06–0.50)), but the difference was not significant (p = 0.67). Limitations: The main limitation was the large number of protocols excluded from the analysis mostly because they did not fit with the clinical trial definition of the new law. Conclusion: A structured risk categorization approach was not better than an ad hoc approach. Laws introducing risk-based approaches should provide guidelines

  5. Impact of wound edge protection devices on surgical site infection after laparotomy: multicentre randomised controlled trial (ROSSINI Trial)

    PubMed Central

    Calvert, Melanie; Bartlett, David C; Gheorghe, Adrian; Redman, Val; Dowswell, George; Hawkins, William; Mak, Tony; Youssef, Haney; Richardson, Caroline; Hornby, Steven; Magill, Laura; Haslop, Richard; Wilson, Sue; Morton, Dion

    2013-01-01

    Objective To determine the clinical effectiveness of wound edge protection devices in reducing surgical site infection after abdominal surgery. Design Multicentre observer blinded randomised controlled trial. Participants Patients undergoing laparotomy at 21 UK hospitals. Interventions Standard care or the use of a wound edge protection device during surgery. Main outcome measures Surgical site infection within 30 days of surgery, assessed by blinded clinicians at seven and 30 days and by patient’s self report for the intervening period. Secondary outcomes included quality of life, duration of stay in hospital, and the effect of characteristics of the patient and operation on the efficacy of the device. Results 760 patients were enrolled with 382 patients assigned to the device group and 378 to the control group. Six patients in the device group and five in the control group did not undergo laparotomy. Fourteen patients, seven in each group, were lost to follow-up. A total of 184 patients experienced surgical site infection within 30 days of surgery, 91/369 (24.7%) in the device group and 93/366 (25.4%) in the control group (odds ratio 0.97, 95% confidence interval 0.69 to 1.36; P=0.85). This lack of benefit was consistent across wound assessments performed by clinicians and those reported by patients and across all secondary outcomes. In the secondary analyses no subgroup could be identified in which there was evidence of clinical benefit associated with use of the device. Conclusions Wound edge protection devices do not reduce the rate of surgical site infection in patients undergoing laparotomy, and therefore their routine use for this role cannot be recommended. Trial registration Current Controlled Trials ISRCTN 40402832 PMID:23903454

  6. Full Scale Field Trial of the Low Temperature Mercury Capture Process

    SciTech Connect

    Locke, James; Winschel, Richard

    2012-05-21

    CONSOL Energy Inc., with partial funding from the Department of Energy (DOE) National Energy Technology Laboratory, designed a full-scale installation for a field trial of the Low-Temperature Mercury Control (LTMC) process, which has the ability to reduce mercury emissions from coal-fired power plants by over 90 percent, by cooling flue gas temperatures to approximately 230°F and absorbing the mercury on the native carbon in the fly ash, as was recently demonstrated by CONSOL R&D on a slip-stream pilot plant at the Allegheny Energy Mitchell Station with partial support by DOE. LTMC has the potential to remove over 90 percent of the flue gas mercury at a cost at least an order of magnitude lower (on a $/lb mercury removed basis) than activated carbon injection. The technology is suitable for retrofitting to existing and new plants, and, although it is best suited to bituminous coal-fired plants, it may have some applicability to the full range of coal types. Installation plans were altered and moved from the original project host site, PPL Martins Creek plant, to a second host site at Allegheny Energy's R. Paul Smith plant, before installation actually occurred at the Jamestown (New York) Board of Public Utilities (BPU) Samuel A. Carlson (Carlson) Municipal Generating Station Unit 12, where the LTMC system was operated on a limited basis. At Carlson, over 60% mercury removal was demonstrated by cooling the flue gas to 220-230°F at the ESP inlet via humidification. The host unit ESP operation was unaffected by the humidification and performed satisfactorily at low temperature conditions.

  7. Efficacy of lufenuron as chemosterilant against Ceratitis capitata in field trials.

    PubMed

    Navarro-Llopis, Vicente; Sanchis-Cabanes, Juan; Ayala, Ildefonso; Casaña-Giner, Victor; Primo-Yüfera, Eduardo

    2004-09-01

    Two field trials in citrus orchards in Turis (Valencia, Spain) and Denia (Alicante, Spain) were performed in order to test the sterilant effect of the insect growth regulator lufenuron against wild medfly Ceratitis capitata (Wiedemann) populations. Two application methods for lufenuron were tested: spraying, in spots, an emulsion of lufenuron in a protein bait, and hanging delta traps that contained a proteinaceous gel with lufenuron (solid bait). The sterilant effect was measured as medfly population reduction, reduction of fruit damage in treated fields, and the number of eggs hatching in punctured fruits. In order to assess the efficacy of lufenuron treatments, we recorded results obtained from two different zones in both trial fields: an outer zone, close to untreated fields, and an inner zone, in the centre of lufenuron treated fields. We observed a minimum sterilant effect in the outer zone and a maximum sterilant effect in the inner one. The maximum sterilant effect was in the inner zone, where a reduction of medfly population of 80.4% in the sprayed field and a reduction of 77.6% in the solid bait field was observed. In addition, the greater the distance from the untreated zones of the treated orchard (inwards), the lower the fruit damage and medfly population level. In this inner zone, fruit punctured by medfly developed significantly fewer larvae (38.8%) than punctured fruits from the outer zone (68.6%). In addition, we recorded the decline in the activity of the lufenuron treatments with time. Lufenuron activity persisted in field for at least 2 weeks with spray applications, and for 3 months with bait gels. PMID:15384180

  8. Transportability of confined field trial data from cultivation to import countries for environmental risk assessment of genetically modified crops.

    PubMed

    Nakai, Shuichi; Hoshikawa, Kana; Shimono, Ayako; Ohsawa, Ryo

    2015-12-01

    Requirement of in-country confined field trials for genetically modified (GM) crops prior to unrestricted release is well-established among countries with domestic regulations for the cultivation approval of GM crops. However, the requirement of in-country confined field trials is not common in countries where the scope of the application does not include cultivation. Nonetheless, Japan and China request in-country confined field trials for GM crops which are intended only for use as food, feed and processing. This paper considers the transportability of confined field trial data from cultivation countries (e.g. United States, Canada, and South American countries) to import countries like Japan for the environmental risk assessment of GM crops by reviewing: (1) the purpose of confined field trial assessment, (2) weediness potential, defined as "an ability to establish and persist in an unmanaged area that is frequently disturbed by human activity", of host crops, and (3) reliability of the confined field trial data obtained from cultivation countries. To review the reliability of the confined field data obtained in the US, this paper describes actual examples of three confined field trials of approved GM corn events conducted both in the US and Japan. Based on the above considerations, this paper concludes that confined field data of GM corn and cotton is transportable from cultivation countries to importing countries (e.g. from the US to Japan), regardless of the characteristics of the inserted gene(s). In addition, this paper advocates harmonization of protocols for confined field trials to facilitate more efficient data transportability across different geographies. PMID:26138875

  9. Transportability of confined field trial data from cultivation to import countries for environmental risk assessment of genetically modified crops.

    PubMed

    Nakai, Shuichi; Hoshikawa, Kana; Shimono, Ayako; Ohsawa, Ryo

    2015-12-01

    Requirement of in-country confined field trials for genetically modified (GM) crops prior to unrestricted release is well-established among countries with domestic regulations for the cultivation approval of GM crops. However, the requirement of in-country confined field trials is not common in countries where the scope of the application does not include cultivation. Nonetheless, Japan and China request in-country confined field trials for GM crops which are intended only for use as food, feed and processing. This paper considers the transportability of confined field trial data from cultivation countries (e.g. United States, Canada, and South American countries) to import countries like Japan for the environmental risk assessment of GM crops by reviewing: (1) the purpose of confined field trial assessment, (2) weediness potential, defined as "an ability to establish and persist in an unmanaged area that is frequently disturbed by human activity", of host crops, and (3) reliability of the confined field trial data obtained from cultivation countries. To review the reliability of the confined field data obtained in the US, this paper describes actual examples of three confined field trials of approved GM corn events conducted both in the US and Japan. Based on the above considerations, this paper concludes that confined field data of GM corn and cotton is transportable from cultivation countries to importing countries (e.g. from the US to Japan), regardless of the characteristics of the inserted gene(s). In addition, this paper advocates harmonization of protocols for confined field trials to facilitate more efficient data transportability across different geographies.

  10. Effect of Topical Tranexamic Acid on Bleeding and Quality of Surgical Field during Functional Endoscopic Sinus Surgery in Patients with Chronic Rhinosinusitis: A Triple Blind Randomized Clinical Trial

    PubMed Central

    Jahanshahi, Javaneh; Hashemian, Farnaz; Pazira, Sara; Bakhshaei, Mohammad Hossein; Farahani, Farhad; Abasi, Ruholah; Poorolajal, Jalal

    2014-01-01

    Background The effect of tranexamic acid (TXA) on bleeding and improvement of surgical field during functional endoscopic sinus surgery (FESS) is not clear yet. This study was conducted to answer this question. Methods This trial was conducted on 60 patients with chronic sinusitis at Beasat Hospital, Hamadan, Iran, from April to November 2013. Thirty patients in the intervention group received three pledgets soaked with TXA 5% and phenylephrine 0.5% for 10 minutes in each nasal cavity before surgery. Thirty patients in the control group received phenylephrine 0.5% with the same way. The amount of bleeding and the quality of surgical field were evaluated at 15, 30, and 45 minutes after the start of surgery using Boezaart grading. Results The quality of the surgical field in the intervention group compared to the control group was significantly better in the first quarter (P = 0.002) and the second quarter (P = 0.003) but not in the third quarter (P = 0.163). Furthermore, the amount of bleeding was much less during all periods in the intervention group than in the control group (P = 0.001). Conclusion Topical TXA can efficiently reduce bleeding and improve the surgical field in FESS in patients with rhinosinusitis. Based on these findings, topical TXA may be a useful method for providing a suitable surgical field during the first 30 minutes after use. Trial Registration Iranian Registry of Clinical Trials IRCT201212139014N15 PMID:25133491

  11. The REFLECT statement: reporting guidelines for randomized controlled trials in livestock and food safety: explanation and elaboration.

    PubMed

    Sargeant, J M; O'Connor, A M; Gardner, I A; Dickson, J S; Torrence, M E; Dohoo, I R; Lefebvre, S L; Morley, P S; Ramirez, A; Snedeker, K

    2010-03-01

    Concerns about the completeness and accuracy of reporting of randomized clinical trials (RCTs) and the impact of poor reporting on decision-making have been documented in the medical field over the past several decades. Experience from RCTs in human medicine would suggest that failure to report critical trial features can be associated with biased estimated effect measures, and there is evidence to suggest similar biases occur in RCTs conducted in livestock populations. In response to these concerns, standardized guidelines for reporting RCTs were developed and implemented in human medicine. The Consolidated Standards of Reporting Trials (CONSORT) statement was first published in 1996 with a revised edition published in 2001. The CONSORT statement consists of a 22-item checklist for reporting a RCT and a flow diagram to follow the number of participants at each stage of a trial. An explanation and elaboration document not only defines and discusses the importance of each of the items, but also provides examples of how this information could be supplied in a publication. Differences between human and livestock populations necessitate modifications to the CONSORT statement to maximize its usefulness for RCTs involving livestock. These have been addressed in an extension of the CONSORT statement titled the REFLECT statement: Methods and processes of creating reporting guidelines for randomized control trials for livestock and food safety. The modifications made for livestock trials specifically addressed the common use of group housing and group allocation to intervention in livestock studies, the use of a deliberate challenge model in some trials, and common use of non-clinical outcomes, such as contamination with a foodborne pathogen. In addition, the REFLECT statement for RCTs in livestock populations proposed specific terms or further clarified terms as they pertained to livestock studies. PMID:20202349

  12. The REFLECT statement: reporting guidelines for Randomized Controlled Trials in livestock and food safety: explanation and elaboration.

    PubMed

    Sargeant, J M; O'Connor, A M; Gardner, I A; Dickson, J S; Torrence, M E

    2010-03-01

    Concerns about the completeness and accuracy of reporting of randomized clinical trials (RCTs) and the impact of poor reporting on decision making have been documented in the medical field over the past several decades. Experience from RCTs in human medicine would suggest that failure to report critical trial features can be associated with biased estimated effect measures, and there is evidence to suggest that similar biases occur in RCTs conducted in livestock populations. In response to these concerns, standardized guidelines for reporting RCTs were developed and implemented in human medicine. The Consolidated Standards of Reporting Trials (CONSORT) statement was first published in 1996, with a revised edition published in 2001. The CONSORT statement consists of a 22-item checklist for reporting a RCT and a flow diagram to follow the number of participants at each stage of a trial. An explanation and elaboration document not only defines and discusses the importance of each of the items, but also provides examples of how this information could be supplied in a publication. Differences between human and livestock populations necessitate modifications to the CONSORT statement to maximize its usefulness for RCTs involving livestock. These have been addressed in an extension of the CONSORT statement titled the REFLECT statement: Methods and processes of creating reporting guidelines for randomized control trials for livestock and food safety. The modifications made for livestock trials specifically addressed the common use of group housing and group allocation to intervention in livestock studies; the use of deliberate challenge models in some trials and the common use of non-clinical outcomes, such as contamination with a foodborne pathogen. In addition, the REFLECT statement for RCTs in livestock populations proposed specific terms or further clarified terms as they pertained to livestock studies. PMID:20070652

  13. Giving bednets "fair" tests in field trials against malaria:a case from Sabah, East Malaysia.

    PubMed

    Leake, D W; Hii, J L

    1989-09-01

    Insecticide-impregnated bednets appear to be a potentially cost-effective intervention against endemic malaria in the tropics, but this has yet to be confirmed by field trials. There are two aspects to consider in assessing such trials: (1) the extent to which subjects use nets regularly and properly, and (2) the effectiveness of nets which are truly used regularly and properly in reducing malaria transmission. The second aspect is currently of primary concern, to determine if human-vector relationships for a particular at-risk population are such that bednets can be effective. But to give bednets a "fair" test in this regard requires regular and proper use in the first place. The study described here suggests they did not get a "fair" test in one field trial in Sabah, East Malaysia. The study also strongly suggests that direct observations, rather than post hoc questioning of subjects, may be essential to accurately gauge bednet usage rates. Accurate usage rates are required to determine what proportion of a population needs to use nets to reduce malaria transmission, and to evaluate the effectiveness of promotional programs over time. Direct observations can also yield valuable data on night-time activities that increase malaria risk, such as television viewing that keeps people awake and out of bednets.

  14. A MultiCenter Pilot Randomized Controlled Trial of Remote Ischemic Preconditioning in Major Vascular Surgery.

    PubMed

    Healy, D A; Boyle, E; McCartan, D; Bourke, M; Medani, M; Ferguson, J; Yagoub, H; Bashar, K; O'Donnell, M; Newell, J; Canning, C; McMonagle, M; Dowdall, J; Cross, S; O'Daly, S; Manning, B; Fulton, G; Kavanagh, E G; Burke, P; Grace, P A; Moloney, M Clarke; Walsh, S R

    2015-11-01

    A pilot randomized controlled trial that evaluated the effect of remote ischemic preconditioning (RIPC) on clinical outcomes following major vascular surgery was performed. Eligible patients were those scheduled to undergo open abdominal aortic aneurysm repair, endovascular aortic aneurysm repair, carotid endarterectomy, and lower limb revascularization procedures. Patients were randomized to RIPC or to control groups. The primary outcome was a composite clinical end point comprising any of cardiovascular death, myocardial infarction, new-onset arrhythmia, cardiac arrest, congestive cardiac failure, cerebrovascular accident, renal failure requiring renal replacement therapy, mesenteric ischemia, and urgent cardiac revascularization. Secondary outcomes were components of the primary outcome and myocardial injury as assessed by serum troponin values. The primary outcome occurred in 19 (19.2%) of 99 controls and 14 (14.1%) of 99 RIPC group patients (P = .446). There were no significant differences in secondary outcomes. Our trial generated data that will guide future trials. Further trials are urgently needed.

  15. Study protocol: a randomised placebo-controlled clinical trial to study the effect of vitamin D supplementation on glycaemic control in type 2 Diabetes Mellitus SUNNY trial

    PubMed Central

    2014-01-01

    Background Besides the classical role of vitamin D on calcium and bone homeostasis, vitamin D deficiency has recently been identified as a contributing factor in the onset of insulin resistance in type 2 diabetes mellitus. However, it is uncertain whether vitamin D deficiency and poor glycaemic control are causally interrelated or that they constitute two independent features of type 2 diabetes mellitus. There are limited clinical trials carried out which measured the effect of vitamin D supplementation on glycaemic control. The objective of this study is to investigate the effect of vitamin D supplementation on glycaemic control and quality of life in patients with type 2 diabetes mellitus. Methods/design In a randomised double-blind placebo-controlled trial conducted in five general practices in the Netherlands three hundred patients with type 2 diabetes mellitus treated with lifestyle advises or metformin or sulphonylurea-derivatives are randomised to receive either placebo or 50,000 IU Vitamin D3 at monthly intervals. The primary outcome measure is the change in glycated haemoglobin level between baseline and six months. Secondary outcome measures include blood pressure, anthropometric parameters, lipid profile, insulin resistance, quality of life, advanced glycation end products and safety profiles. Quality of life will be measured by The Short Form (SF-36) Health Survey questionnaire. Advanced glycation end products are measured by an AGE-reader. Discussion This trial will be the first study exploring the effect of vitamin D supplementation on both glycaemic control and quality of life in patients with type 2 diabetes mellitus. Our findings will contribute to the knowledge of the relationship between vitamin D status and insulin resistance in patients with type 2 diabetes mellitus. Trial registration The Netherlands trial register: NTR3154 PMID:25033925

  16. Elimination of Taenia solium transmission to pigs in a field trial of the TSOL18 vaccine in Cameroon.

    PubMed

    Assana, Emmanuel; Kyngdon, Craig T; Gauci, Charles G; Geerts, Stanny; Dorny, Pierre; De Deken, Redgi; Anderson, Garry A; Zoli, André P; Lightowlers, Marshall W

    2010-04-01

    A pilot field trial of the TSOL18 vaccine was undertaken in Cameroon. Two hundred and forty, 2-3 month-old piglets were distributed to 114 individual households in pairs. Vaccinated animals received three immunisations with 200 microg TSOL18 plus 5 mg Quil A and 30 mg/kg oxfendazole at the time of the second immunisation. Necropsies were undertaken when the pigs were approximately 12 months of age. Viable Taenia solium cysticerci were identified in 20 control pigs (prevalence 19.6%); no cysticerci were found in any of the vaccinated animals (P<0.0001). Combined application of TSOL18 vaccination and a single oxfendazole treatment in pigs may be a relatively simple and sustainable procedure that has the potential to control T. solium transmission in endemic areas and, indirectly, reduce the number of new cases of neurocysticercosis in humans.

  17. Elimination of Taenia solium transmission to pigs in a field trial of the TSOL18 vaccine in Cameroon

    PubMed Central

    Assana, Emmanuel; Kyngdon, Craig T.; Gauci, Charles G.; Geerts, Stanny; Dorny, Pierre; De Deken, Redgi; Anderson, Garry A.; Zoli, André P.; Lightowlers, Marshall W.

    2010-01-01

    A pilot field trial of the TSOL18 vaccine was undertaken in Cameroon. Two hundred and forty, 2–3 month-old piglets were distributed to 114 individual households in pairs. Vaccinated animals received three immunisations with 200 μg TSOL18 plus 5 mg Quil A and 30 mg/kg oxfendazole at the time of the second immunisation. Necropsies were undertaken when the pigs were approximately 12 months of age. Viable Taenia solium cysticerci were identified in 20 control pigs (prevalence 19.6%); no cysticerci were found in any of the vaccinated animals (P < 0.0001). Combined application of TSOL18 vaccination and a single oxfendazole treatment in pigs may be a relatively simple and sustainable procedure that has the potential to control T. solium transmission in endemic areas and, indirectly, reduce the number of new cases of neurocysticercosis in humans. PMID:20138046

  18. Generation of "virtual" control groups for single arm prostate cancer adjuvant trials.

    PubMed

    Jia, Zhenyu; Lilly, Michael B; Koziol, James A; Chen, Xin; Xia, Xiao-Qin; Wang, Yipeng; Skarecky, Douglas; Sutton, Manuel; Sawyers, Anne; Ruckle, Herbert; Carpenter, Philip M; Wang-Rodriguez, Jessica; Jiang, Jun; Deng, Mingsen; Pan, Cong; Zhu, Jian-Guo; McLaren, Christine E; Gurley, Michael J; Lee, Chung; McClelland, Michael; Ahlering, Thomas; Kattan, Michael W; Mercola, Dan

    2014-01-01

    It is difficult to construct a control group for trials of adjuvant therapy (Rx) of prostate cancer after radical prostatectomy (RP) due to ethical issues and patient acceptance. We utilized 8 curve-fitting models to estimate the time to 60%, 65%, … 95% chance of progression free survival (PFS) based on the data derived from Kattan post-RP nomogram. The 8 models were systematically applied to a training set of 153 post-RP cases without adjuvant Rx to develop 8 subsets of cases (reference case sets) whose observed PFS times were most accurately predicted by each model. To prepare a virtual control group for a single-arm adjuvant Rx trial, we first select the optimal model for the trial cases based on the minimum weighted Euclidean distance between the trial case set and the reference case set in terms of clinical features, and then compare the virtual PFS times calculated by the optimum model with the observed PFSs of the trial cases by the logrank test. The method was validated using an independent dataset of 155 post-RP patients without adjuvant Rx. We then applied the method to patients on a Phase II trial of adjuvant chemo-hormonal Rx post RP, which indicated that the adjuvant Rx is highly effective in prolonging PFS after RP in patients at high risk for prostate cancer recurrence. The method can accurately generate control groups for single-arm, post-RP adjuvant Rx trials for prostate cancer, facilitating development of new therapeutic strategies.

  19. Effects of yoga on chronic neck pain: a systematic review of randomized controlled trials

    PubMed Central

    Kim, Sang-Dol

    2016-01-01

    [Purpose] The aim of this study was to investigate the effectiveness of yoga in the management of chronic neck pain. [Subjects and Methods] Five electronic databases were searched to identify randomized controlled trials (RCTs) of yoga intervention on chronic neck pain. The trials were published in the English language between January 1966 and December 2015. The Cochrane Risk of Bias Tool was used to assess the quality of the trials. [Results] Three trials were identified and included in this review. A critical appraisal was performed on the trials, and the result indicated a high risk of bias. A narrative description was processed because of the small number of RCTs. Neck pain intensity and functional disability were significantly lower in the yoga groups than in the control groups. [Conclusion] Evidence from the 3 randomly controlled trials shows that yoga may be beneficial for chronic neck pain. The low-quality result of the critical appraisal and the small number of trials suggest that high-quality RCTs are required to examine further the effects of yoga intervention on chronic neck pain relief. PMID:27512290

  20. Effects of yoga on chronic neck pain: a systematic review of randomized controlled trials.

    PubMed

    Kim, Sang-Dol

    2016-07-01

    [Purpose] The aim of this study was to investigate the effectiveness of yoga in the management of chronic neck pain. [Subjects and Methods] Five electronic databases were searched to identify randomized controlled trials (RCTs) of yoga intervention on chronic neck pain. The trials were published in the English language between January 1966 and December 2015. The Cochrane Risk of Bias Tool was used to assess the quality of the trials. [Results] Three trials were identified and included in this review. A critical appraisal was performed on the trials, and the result indicated a high risk of bias. A narrative description was processed because of the small number of RCTs. Neck pain intensity and functional disability were significantly lower in the yoga groups than in the control groups. [Conclusion] Evidence from the 3 randomly controlled trials shows that yoga may be beneficial for chronic neck pain. The low-quality result of the critical appraisal and the small number of trials suggest that high-quality RCTs are required to examine further the effects of yoga intervention on chronic neck pain relief. PMID:27512290

  1. Treatment of irritable bowel syndrome: a review of randomised controlled trials

    PubMed Central

    AKEHURST, R; KALTENTHALER, E

    2001-01-01

    Irritable bowel syndrome (IBS) is a common chronic disorder that is associated with significant disability and health care costs. The purpose of this paper is to review and assess published randomised controlled trials examining the clinical effectiveness of interventions for IBS for 1987-1998. A literature search was conducted to identify randomised controlled trials of IBS treatments: 45 studies were identified that described randomised controlled trials and of these, six fulfilled all three criteria used to assess the quality of randomised controlled trials, as described by Jadad and colleagues.1 These criteria are: adequate description of randomisation, double blinding, and description of withdrawals and dropouts. It is concluded that there are few studies which offer convincing evidence of effectiveness in treating the IBS symptom complex. This review strongly suggests that future work should include well designed trials that: describe the randomisation method; use internationally approved diagnostic criteria; and are double blinded and placebo controlled. Clear well defined outcome measures are necessary. Inclusion of quality of life measures allows comparison between trials in different therapeutic areas. Conducting such studies will help to overcome some of the difficulties identified in this review.

 PMID:11156653

  2. The Infant Feeding Activity and Nutrition Trial (INFANT) an early intervention to prevent childhood obesity: Cluster-randomised controlled trial

    PubMed Central

    Campbell, Karen; Hesketh, Kylie; Crawford, David; Salmon, Jo; Ball, Kylie; McCallum, Zoë

    2008-01-01

    Background Multiple factors combine to support a compelling case for interventions that target the development of obesity-promoting behaviours (poor diet, low physical activity and high sedentary behaviour) from their inception. These factors include the rapidly increasing prevalence of fatness throughout childhood, the instigation of obesity-promoting behaviours in infancy, and the tracking of these behaviours from childhood through to adolescence and adulthood. The Infant Feeding Activity and Nutrition Trial (INFANT) aims to determine the effectiveness of an early childhood obesity prevention intervention delivered to first-time parents. The intervention, conducted with parents over the infant's first 18 months of life, will use existing social networks (first-time parent's groups) and an anticipatory guidance framework focusing on parenting skills which support the development of positive diet and physical activity behaviours, and reduced sedentary behaviours in infancy. Methods/Design This cluster-randomised controlled trial, with first-time parent groups as the unit of randomisation, will be conducted with a sample of 600 first-time parents and their newborn children who attend the first-time parents' group at Maternal and Child Health Centres. Using a two-stage sampling process, local government areas in Victoria, Australia will be randomly selected at the first stage. At the second stage, a proportional sample of first-time parent groups within selected local government areas will be randomly selected and invited to participate. Informed consent will be obtained and groups will then be randomly allocated to the intervention or control group. Discussion The early years hold promise as a time in which obesity prevention may be most effective. To our knowledge this will be the first randomised trial internationally to demonstrate whether an early health promotion program delivered to first-time parents in their existing social groups promotes healthy eating

  3. Managing data for a randomised controlled clinical trial: experience from the WHO Antenatal Care Trial. WHO Antenatal Care Trial Research Group.

    PubMed

    Pinol, A; Bergel, E; Chaisiri, K; Diaz, E; Gandeh, M

    1998-10-01

    The World Health Organisation, in collaboration with four developing countries, is conducting a randomised controlled clinical trial to evaluate a new programme of antenatal care. In a city or region in Argentina, Cuba, Saudi Arabia and Thailand, 53 clinical units were randomly allocated to provide either the new programme or the programme currently in use. This paper describes the organisation of the data management system used to collect the data. Each woman participating in the trial is uniquely identified, and information such as her name, address and expected delivery date is recorded in the trial 'subject number list'. If the clinic belongs to the intervention group, information about the woman's eligibility is recorded on the classification form. Details of the outcome of the pregnancy are indicated on two additional case report forms: the antenatal hospital admission form and the summary form. When forms are completed by the investigators, they are submitted to the country data coordinating centre (CDCC). The CDCCs are responsible for the processing of the country study forms. This includes verification of the batch of forms, data capture into computer files, data verification, data validation, production of query sheets for data problems, maintenance and updating of study master files. All operations on data such as additions or modifications are performed using transaction processing. At monthly intervals, recruitment reports and transaction files are sent to the trial coordinating centre in Geneva. All transaction files are processed to accumulate data on the trial's consolidated master files. A monthly report including number of women recruited in the trial, adverse events reported by the countries, recruitment charts by clinic and analyses on eligible women in the intervention group is prepared and submitted to the data safety and monitoring committee. A workshop was organised in 1995, before the start of the trial, to introduce the data management

  4. Blinding Techniques in Randomized Controlled Trials of Laser Therapy: An Overview and Possible Solution

    PubMed Central

    Chow, Roberta; Pirotta, Marie

    2008-01-01

    Low-level laser therapy has evidence accumulating about its effectiveness in a variety of medical conditions. We reviewed 51 double blind randomized controlled trials (RCTs) of laser treatment. Analysis revealed 58% of trials showed benefit of laser over placebo. However, less than 5% of the trials had addressed beam disguise or allocation concealment in the laser machines used. Many of the trials used blinding methods that rely on staff cooperation and are therefore open to interference or bias. This indicates significant deficiencies in laser trial methodology. We report the development and preliminary testing of a novel laser machine that can blind both patient and operator to treatment allocation without staff participation. The new laser machine combines sealed preset and non-bypassable randomization codes, decoy lights and sound, and a conical perspex tip to overcome laser diode glow detection. PMID:18955233

  5. A field vaccine trial in Tanzania demonstrates partial protection against malignant catarrhal fever in cattle

    PubMed Central

    Lankester, F.; Russell, G.C.; Lugelo, A.; Ndabigaye, A.; Mnyambwa, N.; Keyyu, J.; Kazwala, R.; Grant, D.; Percival, A.; Deane, D.; Haig, D.M.; Cleaveland, S.

    2016-01-01

    Malignant catarrhal fever (MCF) is a fatal lymphoproliferative disease of cattle that, in East Africa, results from transmission of the causative virus, alcelaphine herpesvirus 1 (AlHV-1), from wildebeest. A vaccine field trial involving an attenuated AlHV-1 virus vaccine was performed over two wildebeest calving seasons on the Simanjiro Plain of northern Tanzania. Each of the two phases of the field trial consisted of groups of 50 vaccinated and unvaccinated cattle, which were subsequently exposed to AlHV-1 challenge by herding toward wildebeest. Vaccination resulted in the induction of virus-specific and virus-neutralizing antibodies. Some cattle in the unvaccinated groups also developed virus-specific antibody responses but only after the start of the challenge phase of the trial. PCR of DNA from blood samples detected AlHV-1 infection in both groups of cattle but the frequency of infection was significantly lower in the vaccinated groups. Some infected animals showed clinical signs suggestive of MCF but few animals went on to develop fatal MCF, with similar numbers in vaccinated and unvaccinated groups. This study demonstrated a baseline level of MCF-seropositivity among cattle in northern Tanzania of 1% and showed that AlHV-1 virus-neutralizing antibodies could be induced in Tanzanian zebu shorthorn cross cattle by our attenuated vaccine, a correlate of protection in previous experimental trials. The vaccine reduced infection rates by 56% in cattle exposed to wildebeest but protection from fatal MCF could not be determined due to the low number of fatal cases. PMID:26706270

  6. A field vaccine trial in Tanzania demonstrates partial protection against malignant catarrhal fever in cattle.

    PubMed

    Lankester, F; Russell, G C; Lugelo, A; Ndabigaye, A; Mnyambwa, N; Keyyu, J; Kazwala, R; Grant, D; Percival, A; Deane, D; Haig, D M; Cleaveland, S

    2016-02-01

    Malignant catarrhal fever (MCF) is a fatal lymphoproliferative disease of cattle that, in East Africa, results from transmission of the causative virus, alcelaphine herpesvirus 1 (AlHV-1), from wildebeest. A vaccine field trial involving an attenuated AlHV-1 virus vaccine was performed over two wildebeest calving seasons on the Simanjiro Plain of northern Tanzania. Each of the two phases of the field trial consisted of groups of 50 vaccinated and unvaccinated cattle, which were subsequently exposed to AlHV-1 challenge by herding toward wildebeest. Vaccination resulted in the induction of virus-specific and virus-neutralizing antibodies. Some cattle in the unvaccinated groups also developed virus-specific antibody responses but only after the start of the challenge phase of the trial. PCR of DNA from blood samples detected AlHV-1 infection in both groups of cattle but the frequency of infection was significantly lower in the vaccinated groups. Some infected animals showed clinical signs suggestive of MCF but few animals went on to develop fatal MCF, with similar numbers in vaccinated and unvaccinated groups. This study demonstrated a baseline level of MCF-seropositivity among cattle in northern Tanzania of 1% and showed that AlHV-1 virus-neutralizing antibodies could be induced in Tanzanian zebu shorthorn cross cattle by our attenuated vaccine, a correlate of protection in previous experimental trials. The vaccine reduced infection rates by 56% in cattle exposed to wildebeest but protection from fatal MCF could not be determined due to the low number of fatal cases.

  7. Periodontal treatment to improve glycaemic control in diabetic patients: study protocol of the randomized, controlled DIAPERIO trial

    PubMed Central

    Vergnes, Jean-Noel; Arrivé, Elise; Gourdy, Pierre; Hanaire, Hélène; Rigalleau, Vincent; Gin, Henri; Sédarat, Cyril; Dorignac, Georges; Bou, Christophe; Sixou, Michel; Nabet, Cathy

    2009-01-01

    Background Periodontitis is a common, chronic inflammatory disease caused by gram-negative bacteria leading to destruction of tissues supporting the teeth. Epidemiological studies have consistently shown increased frequency, extent and severity of periodontitis among diabetic adults. More recently, some controlled clinical trials have also suggested that periodontal treatment could improve glycaemic control in diabetic patients. However current evidence does not provide sufficient information on which to confidently base any clinical recommendations. The main objective of this clinical trial is to assess whether periodontal treatment could lead to a decrease in glycated haemoglobin levels in metabolically unbalanced diabetic patients suffering from chronic periodontitis. Methods The DIAPERIO trial is an open-label, 13-week follow-up, randomized, controlled trial. The total target sample size is planned at 150 participants, with a balanced (1:1) treatment allocation (immediate treatment vs delayed treatment). Periodontal treatment will include full mouth non-surgical scaling and root planing, systemic antibiotherapy, local antiseptics (chlorhexidine 0.12%) and oral health instructions. The primary outcome will be the difference in change of HbA1c between the two groups after the 13-weeks' follow-up. Secondary outcomes will be the difference in change of fructosamine levels and quality of life between the two groups. Discussion The DIAPERIO trial will provide insight into the question of whether periodontal treatment could lead to an improvement in glycaemic control in metabolically unbalanced diabetic patients suffering from periodontitis. The results of this trial will help to provide evidence-based recommendations for clinicians and a draft framework for designing national health policies. Trial registration Current Controlled Trials ISRCTN15334496 PMID:19646281

  8. Corticosteroids in acute traumatic brain injury: systematic review of randomised controlled trials.

    PubMed Central

    Alderson, P.; Roberts, I.

    1997-01-01

    OBJECTIVE: To quantify the effectiveness and safety of corticosteroids in the treatment of acute traumatic brain injury. DESIGN: Systematic review of randomised controlled trials of corticosteroids in acute traumatic brain injury. Summary odds ratios were estimated as an inverse variance weighted average of the odds ratios for each study. SETTING: Randomised trials available by March 1996. SUBJECTS: The included trials with outcome data comprised 2073 randomised participants. RESULTS: The effect of corticosteroids on the risk of death was reported in 13 included trials. The pooled odds ratio for the 13 trials was 0.91 (95% confidence interval 0.74 to 1.12). Pooled absolute risk reduction was 1.8% (-2.5% to 5.7%). For the 10 trials that reported death or disability the pooled odds ratio was 0.90 (0.72 to 1.11). For infections of any type the pooled odds ratio was 0.92 (0.69 to 1.23) and for the seven trials reporting gastrointestinal bleeding it was 1.05 (0.44 to 2.52). With only those trials with the best quality of concealment of allocation, the pooled odds ratio estimates for death and death or disability became closer to unity. CONCLUSIONS: This systematic review of randomised controlled trials of corticosteroids in acute traumatic brain injury shows that there remains considerable uncertainty over their effects. Neither moderate benefits nor moderate harmful effects can be excluded. The widely practicable nature of the drugs and the importance of the health problem suggest that large simple trials are feasible and worth while to establish whether there are any benefits from use of corticosteroids in this setting. PMID:9224126

  9. GeoLab in NASA's Pressurized Excursion Module: First Results from the 2010 Field Trials

    NASA Technical Reports Server (NTRS)

    Evans, Cynthia A.; Calaway, Michael; Bell, Mary Sue; Graff, Trevor

    2010-01-01

    Before humans explore other planets, NASA must develop advanced techniques for collection, preservation and return of unique extraterrestrial samples. To help evaluate hardware requirements and operational concepts for future sample-return missions, we designed and built GeoLab our first generation lab for geological samples into NASA s Habitat Demonstration Unit in the Pressurized Excursion Module (HDU1-PEM). The center of GeoLab is a glovebox for the examination of samples in a shirt-sleeve environment. As part of a deployable habitat, GeoLab can participate in NASA s analog missions that simulate planetary exploration activities and support the testing of relevant technologies for collecting and handling geological samples. Over time, these tests will evaluate sample handling environments (field and lab), sampling tools and analytical instruments, and different scenarios involving both robotic and human procedures. The GeoLab design supports evolving tests and configurations. The glovebox is mounted on the habitat bulkhead, with three sample pass-though chambers that allow for direct sample transfer into the glovebox from the outside. The glovebox design and construction (low-particle shedding, minimally off-gassing materials) provides a clean environment to reduce sample contamination; in the future, we will integrate a positive pressure, enriched nitrogen atmosphere. The glovebox is equipped with configurable instrument ports. The 2010 test included a mass balance, a stereomicroscope with a HD camera for detailed imaging of samples, and a handheld XRF analyzer for preliminary geochemical characterization of samples. Network cameras provided context imagery and sample handling activities. We present early results from the initial field trial of GeoLab during the 2010 Desert Research and Technology Studies (D-RATS) planetary analog test near Flagstaff AZ. The 2010 D-RATS mission involved two rovers, the habitat with GeoLab, four crew members, and a team of

  10. Trends in the methodological quality of published randomized controlled trials on antibacterial agents

    PubMed Central

    Falagas, Matthew E; Pitsouni, Eleni I; Bliziotis, Ioannis A

    2008-01-01

    AIM To investigate the trends of the methodological quality of randomized controlled trials (RCTs) of antimicrobial agents published during the last 30 years. METHODS We randomly selected from the Cochrane Central Register of Controlled Trials database 70 RCTs of antibacterial agents that were published during a 30-year study period (1975–2005); specifically, we randomly selected 10 RCTs published during each of the following years: 1975, 1980, 1985, 1990, 1995, 2000 and 2005. In each of the selected RCTs, we searched for information on various methodological aspects and graded the methodological quality of the RCTs to evaluate trends for possible improvement. RESULTS No improvement was noted in most of the analysed methodological aspects of the RCTs during the 30-year study period. Description of randomization, double blinding, description of the blinding, and allocation concealment were rather scarce among the evaluated RCTs, without observing a trend for improvement during the study period. We noted improvement in reporting power of the study calculations, baseline data as well as in reporting the presence or not of statistical significance and the statistical cut-off of significance. In only 1/70 RCTs were all 13 of the examined methodological quality aspects met and in one more RCT 12 of them were met. CONCLUSIONS We did not observe considerable improvement in the quality of the reporting and methodology of RCTs on antibacterial agents during the last 30 years. The methodological quality aspects that need most improvement are those that help safeguard against various types of biases. WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT Randomized controlled trials (RCTs) are believed to be one of the best methods of clinical research because they can minimize systematic errors of various types. Temporal trends in the various aspects of RCTs have been studied in several medical fields (e.g. nephrology, hepatology, oncology). However, there is lack of data regarding the

  11. TREC-Rio trial: a randomised controlled trial for rapid tranquillisation for agitated patients in emergency psychiatric rooms [ISRCTN44153243

    PubMed Central

    Huf, Gisele; Coutinho, Evandro SF; Adams, Clive E

    2002-01-01

    Background Agitated or violent patients constitute 10% of all emergency psychiatric treatment. Management guidelines, the preferred treatment of clinicians and clinical practice all differ. Systematic reviews show that all relevant studies are small and none are likely to have adequate power to show true differences between treatments. Worldwide, current treatment is not based on evidence from randomised trials. In Brazil, the combination haloperidol-promethazine is frequently used, but no studies involving this mix exist. Methods TREC-Rio (Tranquilização Rápida-Ensaio Clínico [Translation: Rapid Tranquillisation-Clinical Trial]) will compare midazolam with haloperidol-promethazine mix for treatment of agitated patients in emergency psychiatric rooms of Rio de Janeiro, Brazil. TREC-Rio is a randomised, controlled, pragmatic and open study. Primary measure of outcome is tranquillisation at 20 minutes but effects on other measures of morbidity will also be assessed. TREC-Rio will involve the collaboration of as many health care professionals based in four psychiatric emergency rooms of Rio as possible. Because the design of this trial does not substantially complicate clinical management, and in several aspects simplifies it, the study can be large, and treatments used in everyday practice can be evaluated. PMID:12383353

  12. Diarrhea and dengue control in rural primary schools in Colombia: study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Diarrheal diseases and dengue fever are major global health problems. Where provision of clean water is inadequate, water storage is crucial. Fecal contamination of stored water is a common source of diarrheal illness, but stored water also provides breeding sites for dengue vector mosquitoes. Poor household water management and sanitation are therefore potential determinants of both diseases. Little is known of the role of stored water for the combined risk of diarrhea and dengue, yet a joint role would be important for developing integrated control and management efforts. Even less is known of the effect of integrating control of these diseases in school settings. The objective of this trial was to investigate whether interventions against diarrhea and dengue will significantly reduce diarrheal disease and dengue entomological risk factors in rural primary schools. Methods/design This is a 2×2 factorial cluster randomized controlled trial. Eligible schools were rural primary schools in La Mesa and Anapoima municipalities, Cundinamarca, Colombia. Eligible pupils were school children in grades 0 to 5. Schools were randomized to one of four study arms: diarrhea interventions (DIA); dengue interventions (DEN); combined diarrhea and dengue interventions (DIADEN); and control (C). Schools were allocated publicly in each municipality (strata) at the start of the trial, obviating the need for allocation concealment. The primary outcome for diarrhea is incidence rate of diarrhea in school children and for dengue it is density of adult female Aedes aegypti per school. Approximately 800 pupils from 34 schools were enrolled in the trial with eight schools in the DIA arm, nine in the DEN, eight in the DIADEN, and nine in the control arms. The trial status as of June 2012 was: completed baseline data collections; enrollment, randomization, and allocation of schools. The trial was funded by the Research Council of Norway and the Lazos de Calandaima Foundation

  13. The informed consent process in randomised controlled trials: a nurse-led process.

    PubMed

    Cresswell, Pip; Gilmour, Jean

    2014-03-01

    Clinical trials are carried out with human participants to answer questions about the best way to diagnose, treat and prevent illness. Participants must give informed consent to take part in clinical trials that requires understanding of how clinical trials work and their purpose. Randomised controlled trials provide strong evidence but their complex design is difficult for both clinicians and participants to understand. Increasingly, ensuring informed consent in randomised controlled trials has become part of the clinical research nurse role. The aim of this study was to explore in depth the clinical research nurse role in the informed consent process using a qualitative descriptive approach. Three clinical research nurses were interviewed and data analysed using a thematic analysis approach. Three themes were identified to describe the process of ensuring informed consent. The first theme, Preparatory partnerships, canvassed the relationships required prior to initiation of the informed consent process. The second theme, Partnering the participant, emphasises the need for ensuring voluntariness and understanding, along with patient advocacy. The third theme, Partnership with the project, highlights the clinical research nurse contribution to the capacity of the trial to answer the research question through appropriate recruiting and follow up of participants. Gaining informed consent in randomised controlled trials was complex and required multiple partnerships. A wide variety of skills was used to protect the safety of trial participants and promote quality research. The information from this study contributes to a greater understanding of the clinical research nurse role, and suggests the informed consent process in trials can be a nurse-led one. In order to gain collegial, employer and industry recognition it is important this aspect of the nursing role is acknowledged.

  14. Effect of assertive outreach after suicide attempt in the AID (assertive intervention for deliberate self harm) trial: randomised controlled trial

    PubMed Central

    Krogh, Jesper; Erlangsen, Annette; Alberdi, Francisco; Nordentoft, Merete

    2012-01-01

    Objective To assess whether an assertive outreach intervention after suicide attempt could reduce the frequency of subsequent suicidal acts, compared with standard treatment. Design Randomised, parallel group, superiority trial with blinded outcome assessment. Setting Outpatient intervention at one location at Copenhagen University Hospital, Denmark. Participants Patients older than 12 years admitted to regional hospitals in Copenhagen with a suicide attempt within the past 14 days. We excluded patients diagnosed with schizophrenia spectrum disorders and patients living in institutions. Intervention Case management through assertive outreach that provided crisis intervention and flexible problem solving. This approach incorporated motivational support and actively assisted patients to scheduled appointments to improve adherence with after-treatment as an add on to standard treatment. Main outcome Repeated suicide attempt and death by suicide, recorded in medical records and death register at 1-year follow-up. Results 243 patients were included. During 12 months of follow-up, 20/123 (16%) patients in the intervention group had been registered in hospital records with subsequent suicide attempt, compared with 13/120 (11%) in the control group (odds ratio 1.60, 95% confidence interval 0.76 to 3.38; P=0.22). By contrast, self reported data on new events showed 11/95 (12%) in the intervention group versus 13/74 (18%) in the control group (0.61, 0.26 to 1.46; P=0.27). By imputing missing data on the selfreported outcomes, we estimated 15/123 (12%) events in the intervention group and 23/120 (19%) in the control group (0.69, 0.34 to 1.43; P=0.32). Conclusion Assertive outreach showed no significant effect on subsequent suicide attempt. The difference in rates of events between register data and self reported data could indicate detection bias. Trial registration ClinicalTrials.gov NCT00700089. PMID:22915730

  15. Transcutaneous electrical nerve stimulation for the management of tennis elbow: a pragmatic randomized controlled trial: the TATE trial (ISRCTN 87141084)

    PubMed Central

    2009-01-01

    Background Tennis elbow is a common and often extremely painful musculoskeletal condition, which has considerable impact on individuals as well as economic implications for healthcare utilization and absence from work. Many management strategies have been studied in clinical trials. Whilst corticosteroid injections offer short term pain relief, this treatment is unpleasant and is used with caution due to an associated high risk of pain recurrence in the long term. Systematic reviews conclude that there is no clear and effective treatment for symptoms of pain in the first 6 weeks of the condition. There is a clear need for an intervention that is acceptable to patients and provides them with effective short-term pain relief without increasing the risk of recurrence. Transcutaneous electrical nerve stimulation (TENS) is an inexpensive, non-invasive, non-pharmacological form of analgesia that is commonly used in the treatment of pain. TENS has very few contraindications and is simple to apply. It also benefits from being patient controlled, thereby promoting self-management. This study aims to assess the effectiveness, in terms of pain relief, and cost-effectiveness of a self-management package of treatment that includes TENS. Methods/Design The design of the study will be a two-group pragmatic randomized clinical trial. 240 participants aged 18 years and over with tennis elbow will be recruited from 20-30 GP practices in Staffordshire, UK. Participants are to be randomized on a 1:1 basis to receive either primary care management (standard GP consultation, medication, advice and education) or primary care management with the addition of TENS, over 6 weeks. Our primary outcome measure is average intensity of elbow pain in the past 24 hours (0-10 point numerical rating scale) at 6 weeks. Secondary outcomes include pain and limitation of function, global assessment of change, days of sick leave, illness perceptions, and overall health status. A cost

  16. SWIM (sickle with ibuprofen and morphine) randomised controlled trial fails to recruit: lessons learnt

    PubMed Central

    Cho, Gavin; Anie, Kofi A; Buckton, Jacky; Kiilu, Patricia; Layton, Mark; Alexander, Lydia; Hemmaway, Claire; Sutton, Dorothy; Amos, Claire; Doré, Caroline J; Kahan, Brennan; Meredith, Sarah

    2016-01-01

    Objectives Sickle With Ibuprofen and Morphine (SWIM) trial was designed to assess whether co-administration of ibuprofen (a non-steroidal anti-inflammatory drug) resulted in a reduction of opioid consumption delivered by patient-controlled analgesia (PCA) for acute pain in sickle cell disease. Design A randomised, placebo-controlled, double-blind trial. Setting UK multicentre trial in acute hospital setting. Participants Adults with sickle cell disease of any gender and phenotype aged 16 years and over. Interventions Oral ibuprofen at a dose of 800 mg three times daily or placebo in addition to opioids (morphine or diamorphine) administered via PCA pump for up to 4 days. Main outcome measures The primary outcome measure was opioid consumption over 4 days following randomisation. Results The SWIM trial closed early because it failed to randomise to its target of 316 patients within a reasonable time. Conclusions The key issues identified include the unanticipated length of time between informed consent and randomisation, difficulties in randomisation of patients in busy emergency departments, availability of trained staff at weekends and out of hours, fewer centres than expected using PCA routinely for sickle cell pain treatment, lack of research staff and support for participation, and the trial design. There are implications for future UK trials in sickle cell disease. Trial registration number ISRCTN97241637, NCT00880373; Pre-results. PMID:27288381

  17. Niacin and vitamin B6 in mental functioning: a review of controlled trials in humans.

    PubMed

    Kleijnen, J; Knipschild, P

    1991-05-01

    Fifty-three controlled trials of the effects of niacin, vitamin B6, and multivitamins on mental functions are reviewed. The results are interpreted with emphasis on the methodological quality of the trials. It turns out that virtually all trials show serious short-comings: in the number of participants, the presentation of baseline characteristics and outcomes, and the description of changes in concomitant treatments. Only in autistic children are some positive results are found with very high dosages of vitamin B6 combined with magnesium, but further evidence is needed before more definitive conclusions can be drawn. For many other indications (hyperactive children, children with Down's syndrome, IQ changes in healthy schoolchildren, schizophrenia, psychological functions in healthy adults and geriatric patients) there is no adequate support from controlled trials in favor of vitamin supplementation. PMID:1828703

  18. Ethics of Placebo Control in Trials for Idiopathic Sudden Sensorineural Hearing Loss.

    PubMed

    Maldonado Fernández, Miguel; Kornetsky, Susan; Rubio Rodriguez, Laura

    2016-07-01

    Idiopathic sudden sensorineural hearing loss (ISSHL) involves sudden loss of hearing from cochlear or retrocochlear origin of unknown cause. Systemic corticosteroids may be considered in the management of ISSNHL. However, an updated Cochrane systematic review concludes that "the value of steroids in the treatment of idiopathic sudden sensorineural hearing loss remains unclear since the evidence obtained from randomized controlled trials is contradictory in outcome." Therefore, a new clinical trial that addresses this question is mandatory. A first step in its design is to determine if placebo control would be ethically acceptable. We conclude that there is equipoise (uncertainty) about the use of corticosteroids for ISSHL. A new trial is justified-but with the inclusion of interim analyses to detect early imbalances on efficacy or safety and with the ability to stop the trial if needed.

  19. Ethics of Placebo Control in Trials for Idiopathic Sudden Sensorineural Hearing Loss.

    PubMed

    Maldonado Fernández, Miguel; Kornetsky, Susan; Rubio Rodriguez, Laura

    2016-07-01

    Idiopathic sudden sensorineural hearing loss (ISSHL) involves sudden loss of hearing from cochlear or retrocochlear origin of unknown cause. Systemic corticosteroids may be considered in the management of ISSNHL. However, an updated Cochrane systematic review concludes that "the value of steroids in the treatment of idiopathic sudden sensorineural hearing loss remains unclear since the evidence obtained from randomized controlled trials is contradictory in outcome." Therefore, a new clinical trial that addresses this question is mandatory. A first step in its design is to determine if placebo control would be ethically acceptable. We conclude that there is equipoise (uncertainty) about the use of corticosteroids for ISSHL. A new trial is justified-but with the inclusion of interim analyses to detect early imbalances on efficacy or safety and with the ability to stop the trial if needed. PMID:27371619

  20. Carrier signal technology applied to solar collector field control

    SciTech Connect

    Alvis, R.L.

    1981-01-01

    The development and operational performance are described of a control system designed specifically for solar distributed collector field systems. Carrier technology is employed to eliminate costly field constructed control wiring and allows the control system quality to be controlled at system suppliers' plants. Prototype hardware has been built and tested in the field with excellent operating results.

  1. Topical treatment of tungiasis: a randomized, controlled trial.

    PubMed

    Heukelbach, J; Eisele, M; Jackson, A; Feldmeier, H

    2003-10-01

    Tungiasis is caused by the penetration of the female sand flea Tunga penetrans into the epidermis of its host. Human infestation with this ectoparasite is hyper-endemic in many resource-poor communities in sub-Saharan Africa, the Caribbean and South America and is associated with considerable morbidity. Currently, there is no effective drug available to treat tungiasis (or at least none for which a parasiticidal effect has been clearly demonstrated). In an attempt to fill this gap, the effects of treatment with topical ivermectin (lotion), thiabendazole (ointment and lotion), metrifonate (lotion) or placebo lotion were compared in a randomized trial. A total of 108 subjects with 169 tungiasis-infested feet participated in the study. The results show that topical ivermectin, metrifonate or thiabendazole can each significantly reduce the number of lesions caused by embedded sand fleas. Further studies are needed to optimise the doses and administration of these compounds.

  2. The home stroke rehabilitation and monitoring system trial: a randomized controlled trial

    PubMed Central

    Linder, Susan M.; Rosenfeldt, Anson B.; Reiss, Aimee; Buchanan, Sharon; Sahu, Komal; Bay, Curtis R.; Wolf, Steven L.; Alberts, Jay L.

    2015-01-01

    Rationale Because many individuals post-stroke lack access to the quality and intensity of rehabilitation to improve upper extremity (UE) motor function, a home-based robotic-assisted UE rehabilitation device is being paired with an individualized home exercise program (HEP). Aims/Hypothesis The primary aim of this project is to determine the effectiveness of robotic-assisted home therapy compared to a home exercise program on UE motor recovery and health-related quality of life for stroke survivors in rural and underserved locations. The secondary aim is to explore whether initial degree of motor function of the upper limb may be a factor in predicting the extent to which patients with stroke may be responsive to a home therapy approach. The HEP intervention, when enhanced with robotic-assisted therapy will result in significantly better outcomes in motor function and quality of life. Design A total of 96 participants within six months of a single, unilateral ischemic or hemorrhagic stroke will be recruited in this prospective, single-blind, multi-site randomized clinical trial. Study Outcomes The primary outcome is the change in UE function using the Action Research Arm Test. Secondary outcomes include changes in: UE function (Wolf Motor Function Test), UE impairment (UE portion of the Fugl-Meyer Test), self-reported quality of life (Stroke Impact Scale), and affect (Centers for Epidemiologic Studies Depression Scale). Discussion Similar or greater improvements in UE function using the combined robotic-HEP intervention compared to HEP alone will be interpreted as evidence that supports the introduction of in-home technology to augment the recovery of function post-stroke. PMID:23280269

  3. Pragmatic consideration of recent randomized, placebo-controlled clinical trials for treatment of fibromyalgia.

    PubMed

    Holman, Andrew J

    2008-12-01

    A flurry of recent randomized, placebo-controlled trials assessing dissimilar pharmacotherapeutic treatment options for fibromyalgia (FM) have been presented in the past few years. This review evaluates these trials in light of recent pathophysiological concepts germane to FM, including mood disorders, autonomic dysregulation, altered sleep stage architecture, and the diagnostic tender point controversy. Studies with gabapentin, pregabalin, duloxetine, milnacipran, sodium oxybate, and pramipexole for treatment of FM are discussed.

  4. Acupuncture as a treatment for functional dyspepsia: design and methods of a randomized controlled trial

    PubMed Central

    Zheng, Hui; Tian, Xiao-ping; Li, Ying; Liang, Fan-rong; Yu, Shu-guang; Liu, Xu-guang; Tang, Yong; Yang, Xu-guang; Yan, Jie; Sun, Guo-jie; Chang, Xiao-rong; Zhang, Hong-xing; Ma, Ting-ting; Yu, Shu-yuan

    2009-01-01

    Background Acupuncture is widely used in China to treat functional dyspepsia (FD). However, its effectiveness in the treatment of FD, and whether FD-specific acupoints exist, are controversial. So this study aims to determine if acupuncture is an effective treatment for FD and if acupoint specificity exists according to traditional acupuncture meridians and acupoint theories. Design This multicenter randomized controlled trial will include four acupoint treatment groups, one non-acupoint control group and one drug (positive control) group. The four acupoint treatment groups will focus on: (1) specific acupoints of the stomach meridian; (2) non-specific acupoints of the stomach meridian; (3) specific acupoints of alarm and transport points; and (4) acupoints of the gallbladder meridian. These four groups of acupoints are thought to differ in terms of clinical efficacy, according to traditional acupuncture meridians and acupoint theories. A total of 120 FD patients will be included in each group. Each patient will receive 20 sessions of acupuncture treatment over 4 weeks. The trial will be conducted in eight hospitals located in three centers of China. The primary outcomes in this trial will include differences in Nepean Dyspepsia Index scores and differences in the Symptom Index of Dyspepsia before randomization, 2 weeks and 4 weeks after randomization, and 1 month and 3 months after completing treatment. Discussion The important features of this trial include the randomization procedures (controlled by a central randomization system), a standardized protocol of acupuncture manipulation, and the fact that this is the first multicenter randomized trial of FD and acupuncture to be performed in China. The results of this trial will determine whether acupuncture is an effective treatment for FD and whether using different acupoints or different meridians leads to differences in clinical efficacy. Trial registration number Clinical Trials.gov Identifier: NCT00599677

  5. The CHIPS Randomized Controlled Trial (Control of Hypertension in Pregnancy Study)

    PubMed Central

    von Dadelszen, Peter; Singer, Joel; Lee, Terry; Rey, Evelyne; Ross, Susan; Asztalos, Elizabeth; Murphy, Kellie E.; Menzies, Jennifer; Sanchez, Johanna; Gafni, Amiram; Helewa, Michael; Hutton, Eileen; Koren, Gideon; Lee, Shoo K.; Logan, Alexander G.; Ganzevoort, Wessel; Welch, Ross; Thornton, Jim G.; Moutquin, Jean-Marie

    2016-01-01

    To determine whether clinical outcomes differed by occurrence of severe hypertension in the international CHIPS trial (Control of Hypertension in Pregnancy Study), adjusting for the interventions of “less tight” (target diastolic blood pressure [dBP] 100 mm Hg) versus “tight” control (target dBP 85 mm Hg). In this post-hoc analysis of CHIPS data from 987 women with nonsevere nonproteinuric preexisting or gestational hypertension, mixed effects logistic regression was used to compare the following outcomes according to occurrence of severe hypertension, adjusting for allocated group and the influence of baseline factors: CHIPS primary (perinatal loss or high-level neonatal care for >48 hours) and secondary outcomes (serious maternal complications), birth weight <10th percentile, preeclampsia, delivery at <34 or <37 weeks, platelets <100×109/L, elevated liver enzymes with symptoms, maternal length of stay ≥10 days, and maternal readmission before 6 weeks postpartum. Three hundred and thirty-four (34.1%) women in CHIPS developed severe hypertension that was associated with all outcomes examined except for maternal readmission (P=0.20): CHIPS primary outcome, birth weight <10th percentile, preeclampsia, preterm delivery, elevated liver enzymes (all P<0.001), platelets <100×109/L (P=0.006), and prolonged hospital stay (P=0.03). The association between severe hypertension and serious maternal complications was seen only in less tight control (P=0.02). Adjustment for preeclampsia (464, 47.3%) did not negate the relationship between severe hypertension and the CHIPS primary outcome (P<0.001), birth weight <10th percentile (P=0.005), delivery at <37 (P<0.001) or <34 weeks (P<0.001), or elevated liver enzymes with symptoms (P=0.02). Severe hypertension is a risk marker for adverse maternal and perinatal outcomes, independent of BP control or preeclampsia co-occurrence. Clinical Trial Registration— URL: http://pre-empt.cfri.ca/. Unique identifier: ISRCTN

  6. Conveying Equipoise during Recruitment for Clinical Trials: Qualitative Synthesis of Clinicians’ Practices across Six Randomised Controlled Trials

    PubMed Central

    Jepson, Marcus; Strong, Sean; Wilson, Caroline; Beard, David; Blazeby, Jane M.; Birtle, Alison; Halliday, Alison

    2016-01-01

    Background Randomised controlled trials (RCTs) are essential for evidence-based medicine and increasingly rely on front-line clinicians to recruit eligible patients. Clinicians’ difficulties with negotiating equipoise is assumed to undermine recruitment, although these issues have not yet been empirically investigated in the context of observable events. We aimed to investigate how clinicians conveyed equipoise during RCT recruitment appointments across six RCTs, with a view to (i) identifying practices that supported or hindered equipoise communication and (ii) exploring how clinicians’ reported intentions compared with their actual practices. Methods and Findings Six pragmatic UK-based RCTs were purposefully selected to include several clinical specialties (e.g., oncology, surgery) and types of treatment comparison. The RCTs were all based in secondary-care hospitals (n = 16) around the UK. Clinicians recruiting to the RCTs were interviewed (n = 23) to understand their individual sense of equipoise about the RCT treatments and their intentions for communicating equipoise to patients. Appointments in which these clinicians presented the RCT to trial-eligible patients were audio-recorded (n = 105). The appointments were analysed using thematic and content analysis approaches to identify practices that supported or challenged equipoise communication. A sample of appointments was independently coded by three researchers to optimise reliability in reported findings. Clinicians and patients provided full written consent to be interviewed and have appointments audio-recorded. Interviews revealed that clinicians’ sense of equipoise varied: although all were uncertain about which trial treatment was optimal, they expressed different levels of uncertainty, ranging from complete ambivalence to clear beliefs that one treatment was superior. Irrespective of their personal views, all clinicians intended to set their personal biases aside to convey trial treatments

  7. Distinct effects of trial-driven and task Set-related control in primary visual cortex.

    PubMed

    Griffis, Joseph C; Elkhetali, Abdurahman S; Vaden, Ryan J; Visscher, Kristina M

    2015-10-15

    Task sets are task-specific configurations of cognitive processes that facilitate task-appropriate reactions to stimuli. While it is established that the trial-by-trial deployment of visual attention to expected stimuli influences neural responses in primary visual cortex (V1) in a retinotopically specific manner, it is not clear whether the mechanisms that help maintain a task set over many trials also operate with similar retinotopic specificity. Here, we address this question by using BOLD fMRI to characterize how portions of V1 that are specialized for different eccentricities respond during distinct components of an attention-demanding discrimination task: cue-driven preparation for a trial, trial-driven processing, task-initiation at the beginning of a block of trials, and task-maintenance throughout a block of trials. Tasks required either unimodal attention to an auditory or a visual stimulus or selective intermodal attention to the visual or auditory component of simultaneously presented visual and auditory stimuli. We found that while the retinotopic patterns of trial-driven and cue-driven activity depended on the attended stimulus, the retinotopic patterns of task-initiation and task-maintenance activity did not. Further, only the retinotopic patterns of trial-driven activity were found to depend on the presence of inter-modal distraction. Participants who performed well on the intermodal selective attention tasks showed strong task-specific modulations of both trial-driven and task-maintenance activity. Importantly, task-related modulations of trial-driven and task-maintenance activity were in opposite directions. Together, these results confirm that there are (at least) two different processes for top-down control of V1: One, working trial-by-trial, differently modulates activity across different eccentricity sectors - portions of V1 corresponding to different visual eccentricities. The second process works across longer epochs of task performance, and

  8. Effects of a Worksite Weight-Control Programme in Obese Male Workers: A Randomized Controlled Crossover Trial

    ERIC Educational Resources Information Center

    Iriyama, Yae; Murayama, Nobuko

    2014-01-01

    Objective: We conducted a randomized controlled crossover trial to evaluate the effects of a new worksite weight-control programme designed for men with or at risk of obesity using a combination of nutrition education and nutrition environmental interventions. Subjects and methods: Male workers with or at risk of obesity were recruited for this…

  9. A RANDOMIZED CONTROLLED TRIAL OF RESISTANCE EXERCISE TRAINING TO IMPROVE GLYCEMIC CONTROL IN OLDER ADULTS WITH TYPE 2 DIABETES

    Technology Transfer Automated Retrieval System (TEKTRAN)

    OBJECTIVE-To determine the efficacy of high-intensity progressive resistance training (PRT) on glycemic control in older adults with type 2 diabetes. RESEARCH DESIGN AND METHODS-We performed a 16-week randomized controlled trial in 62 Latino older adults (40 women and 22 men; mean +/- SE age 66 +/...

  10. Social Stories in mainstream schools for children with autism spectrum disorder: a feasibility randomised controlled trial

    PubMed Central

    Marshall, David; Wright, Barry; Allgar, Victoria; Adamson, Joy; Williams, Christine; Ainsworth, Hannah; Cook, Liz; Varley, Danielle; Hackney, Lisa; Dempster, Paul; Ali, Shehzad; Trepel, Dominic; Collingridge Moore, Danielle; Littlewood, Elizabeth; McMillan, Dean

    2016-01-01

    Objectives To assess the feasibility of recruitment, retention, outcome measures and intervention training/delivery among teachers, parents and children. To calculate a sample size estimation for full trial. Design A single-centre, unblinded, cluster feasibility randomised controlled trial examining Social Stories delivered within a school environment compared with an attentional control. Setting 37 primary schools in York, UK. Participants 50 participants were recruited and a cluster randomisation approach by school was examined. Participants were randomised into the treatment group (n=23) or a waiting list control group (n=27). Outcome measures Acceptability and feasibility of the trial, intervention and of measurements required to assess outcomes in a definitive trial. Results An assessment of the questionnaire completion rates indicated teachers would be most appropriate to complete the primary outcome measure. 2 outcome measures: the Social Responsiveness Scale (SRS)-2 and a goal-based measure showed both the highest levels of completion rates (above 80%) at the primary follow-up point (6 weeks postintervention) and captured relevant social and behaviour outcomes. Power calculations were based on these 2 outcome measures leading to a total proposed sample size of 180 participant groups. Conclusions Results suggest that a future trial would be feasible to conduct and could inform the policy and practice of using Social Stories in mainstream schools. Trial registration number ISRCTN96286707; Results. PMID:27515756

  11. Declining efficacy in controlled trials of antidepressants: effects of placebo dropout.

    PubMed

    Schalkwijk, Stein; Undurraga, Juan; Tondo, Leonardo; Baldessarini, Ross J

    2014-08-01

    Drug-placebo differences (effect-sizes) in controlled trials of antidepressants for major depressive episodes have declined for several decades, in association with selectively increasing clinical improvement associated with placebo-treatment. As these trends require adequate explanation, we tested the hypothesis that decreasing trial-dropout rates may be an important contributor. We gathered reports of peer-reviewed, placebo-controlled trials of antidepressants (1980-2011) by computerized literature searching, and applied meta-analysis, meta-regression and multiple linear regression methods to evaluate associations of dropout rates and other factors of interest, to reporting year and reported efficacy [standardized mean drug-placebo difference (SMD) as Hedges' g-statistic]. In 56 trials meeting inclusion and exclusion criteria, we confirmed significant overall efficacy of antidepressants but declining drug-placebo contrasts over the past three decades. Among other changes, there was a corresponding increase in placebo-associated improvement with a decline in placebo-dropout rate, mainly for lack of efficacy. These effects were found only when last-observation-carried-forward (LOCF) analyses were used. Other trial-design and subject factors, including drug-responses and drug-dropout rates, were much less associated with efficacy. We propose that declining placebo-dropout rates ascribed to inefficacy combined with use of LOCF analyses led to increasing improvement in placebo-arms that contributed to declining antidepressant-placebo contrasts in controlled treatment trials since the 1980s.

  12. [Planning and data analysis in prospective controlled clinical trials (author's transl)].

    PubMed

    Barth, H

    1978-11-01

    Planning of prospective controlled clinical trials in surgery requires the use of test and control groups, sufficiently frequent repetition of experiments, random allocation of patients to the groups (example), and balancing. The descriptive data analysis should be performed in a stepwise manner (list of new data, rank list, range, median, quartiles, histogram, mean value standard deviation). The advantages of the median-quartile-system and the prerequisites for application of various significance tests are pointed out. In the conduct of controlled clinical trials, the consultative role of experimental surgeons is proposed.

  13. How large are the nonspecific effects of acupuncture? A meta-analysis of randomized controlled trials

    PubMed Central

    2010-01-01

    Background While several recent large randomized trials found clinically relevant effects of acupuncture over no treatment or routine care, blinded trials comparing acupuncture to sham interventions often reported only minor or no differences. This raises the question whether (sham) acupuncture is associated with particularly potent nonspecific effects. We aimed to investigate the size of nonspecific effects associated with acupuncture interventions. Methods MEDLINE, Embase, Cochrane Central Register of Controlled Clinical Trials and reference lists were searched up to April 2010 to identify randomized trials of acupuncture for any condition, including both sham and no acupuncture control groups. Data were extracted by one reviewer and verified by a second. Pooled standardized mean differences were calculated using a random effects model with the inverse variance method. Results Thirty-seven trials with a total of 5754 patients met the inclusion criteria. The included studies varied strongly regarding patients, interventions, outcome measures, methodological quality and effect sizes reported. Among the 32 trials reporting a continuous outcome measure, the random effects standardized mean difference between sham acupuncture and no acupuncture groups was -0.45 (95% confidence interval, -0.57, -0.34; I2 = 54%; Egger's test for funnel plot asymmetry, P = 0.25). Trials with larger effects of sham over no acupuncture reported smaller effects of acupuncture over sham intervention than trials with smaller nonspecific effects (β = -0.39, P = 0.029). Conclusions Sham acupuncture interventions are often associated with moderately large nonspecific effects which could make it difficult to detect small additional specific effects. Compared to inert placebo interventions, effects associated with sham acupuncture might be larger, which would have considerable implications for the design and interpretation of clinical trials. PMID:21092261

  14. Trial-by-Trial Analysis or Averaging: Implications for Electromyographic Models of Rapid Limb Control

    ERIC Educational Resources Information Center

    Sherwood, David E.; Enebo, Brian A.

    2007-01-01

    The control of human limb movement has been the focus of research for more than a century. A major issue to emerge from this work is the manner in which the central nervous system regulates electromyographic (EMG) activity to produce movements that differ in distance, velocity, and movement time. However, the different methods of analysis often…

  15. Nutritional route in oesophageal resection trial II (NUTRIENT II): study protocol for a multicentre open-label randomised controlled trial

    PubMed Central

    Berkelmans, Gijs H K; Wilts, Bas J W; Kouwenhoven, Ewout A; Kumagai, Koshi; Nilsson, Magnus; Weijs, Teus J; Nieuwenhuijzen, Grard A P; van Det, Marc J; Luyer, Misha D P

    2016-01-01

    Introduction Early start of an oral diet is safe and beneficial in most types of gastrointestinal surgery and is a crucial part of fast track or enhanced recovery protocols. However, the feasibility and safety of oral intake directly following oesophagectomy remain unclear. The aim of this study is to investigate the effects of early versus delayed start of oral intake on postoperative recovery following oesophagectomy. Methods and analysis This is an open-label multicentre randomised controlled trial. Patients undergoing elective minimally invasive or hybrid oesophagectomy for cancer are eligible. Further inclusion criteria are intrathoracic anastomosis, written informed consent and age 18 years or older. Inability for oral intake, inability to place a feeding jejunostomy, inability to provide written consent, swallowing disorder, achalasia, Karnofsky Performance Status <80 and malnutrition are exclusion criteria. Patients will be randomised using online randomisation software. The intervention group (direct oral feeding) will receive a liquid oral diet for 2 weeks with gradually expanding daily maximums. The control group (delayed oral feeding) will receive enteral feeding via a jejunostomy during 5 days and then start the same liquid oral diet. The primary outcome measure is functional recovery. Secondary outcome measures are 30-day surgical complications; nutritional status; need for artificial nutrition; need for additional interventions; health-related quality of life. We aim to recruit 148 patients. Statistical analysis will be performed according to an intention to treat principle. Results are presented as risk ratios with corresponding 95% CIs. A two-tailed p<0.05 is considered statistically significant. Ethics and dissemination Our study protocol has received ethical approval from the Medical research Ethics Committees United (MEC-U). This study is conducted according to the principles of Good Clinical Practice. Verbal and written informed consent is

  16. A Randomized Controlled Trial of Brief Interventions for Body Dissatisfaction

    ERIC Educational Resources Information Center

    Wade, Tracey; George, Wing Man; Atkinson, Melissa

    2009-01-01

    The authors examined the relative effectiveness of 3 different approaches to the experience of body dissatisfaction compared to a control and ruminative attention control condition, with respect to increasing weight and appearance satisfaction. One hundred female undergraduates (mean age = 24.38, SD = 9.39) underwent a body dissatisfaction…

  17. A Compound Herbal Preparation (CHP) in the Treatment of Children with ADHD: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Katz, M.; Adar Levine, A.; Kol-Degani, H.; Kav-Venaki, L.

    2010-01-01

    Objective: Evaluation of the efficacy of a patented, compound herbal preparation (CHP) in improving attention, cognition, and impulse control in children with ADHD. Method: Design: A randomized, double-blind, placebo-controlled trial. Setting: University-affiliated tertiary medical center. Participants: 120 children newly diagnosed with ADHD,…

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

    ERIC Educational Resources Information Center

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

    2011-01-01

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

  19. The Efficacy of Parent-Child Interaction Therapy with Chinese Families: Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leung, Cynthia; Tsang, Sandra; Sin, Tammy C. S.; Choi, Siu-yan

    2015-01-01

    Objective: This study aimed to examine the efficacy of the Parent-Child Interaction Therapy (PCIT) in Hong Kong Chinese families, using randomized controlled trial design. Methods: The participants included 111 Hong Kong Chinese parents with children aged 2--7 years old, who were randomized into the intervention group (n = 54) and control group (n…

  20. Intention-to-Treat Analysis in Partially Nested Randomized Controlled Trials with Real-World Complexity

    ERIC Educational Resources Information Center

    Schweig, Jonathan David; Pane, John F.

    2016-01-01

    Demands for scientific knowledge of what works in educational policy and practice has driven interest in quantitative investigations of educational outcomes, and randomized controlled trials (RCTs) have proliferated under these conditions. In educational settings, even when individuals are randomized, both experimental and control students are…

  1. Randomized Trial of Anger Control Training for Adolescents with Tourette's Syndrome and Disruptive Behavior

    ERIC Educational Resources Information Center

    Sukhdolsky, Denis G.; Vitulano, Lawrence A.; Carroll, Deirdre H.; McGuire, Joseph; Leckman, James F.; Scahill, Lawrence

    2009-01-01

    A randomized trial to examine the efficacy of anger control training for treating adolescents with Tourette's syndrome and disruptive behavior reveals that those administered with the anger control training showed a decrease in their Disruptive Behavior Rating Scale score by 52 percent as compared with a decrease of 11 percent in the treatment as…

  2. Disseminating the Positively Aging[R] Teaching Materials: Results of a Controlled Trial

    ERIC Educational Resources Information Center

    Lichtenstein, Michael J.; Pruski, Linda A.; Marshall, Carolyn E.; Blalock, Cheryl L.; Liu, Yan; Plaetke, Rosemarie

    2005-01-01

    This study tested the effectiveness of 2 dissemination methods for the Positively Aging teaching materials. In San Antonio, Texas, 4 middle schools participated in a 3-year controlled trial of dissemination via distance electronic support alone (control) compared to distance electronic support plus in-school support from study staff…

  3. Meta-Analysis of Randomized, Controlled Treatment Trials for Pediatric Obsessive-Compulsive Disorder

    ERIC Educational Resources Information Center

    Watson, Hunna J.; Rees, Clare S.

    2008-01-01

    Objective: To conduct a meta-analysis on randomized, controlled treatment trials of pediatric obsessive-compulsive disorder (OCD). Method: Studies were included if they employed randomized, controlled methodology and treated young people (19 years or under) with OCD. A comprehensive literature search identified 13 RCTs containing 10…

  4. Outcomes from a School-Randomized Controlled Trial of Steps to Respect: A Bullying Prevention Program

    ERIC Educational Resources Information Center

    Brown, Eric C.; Low, Sabina; Smith, Brian H.; Haggerty, Kevin P.

    2011-01-01

    This study reports the outcomes of a randomized controlled trial of Steps to Respect: A Bullying Prevention Program conducted in 33 California elementary schools. Schools were matched on school demographic characteristics and assigned randomly to intervention or waitlisted control conditions. Outcome measures were obtained from (a) all school…

  5. Randomized Control Trial of a CBT Trauma Recovery Program in Palestinian Schools

    ERIC Educational Resources Information Center

    Barron, Ian G.; Abdallah, Ghassan; Smith, Patrick

    2013-01-01

    The current study aimed to assess the Teaching Recovery Techniques (TRT) trauma recovery program within the context of ongoing violence. Utilizing a randomized controlled trial, 11-14-year-old students in Nablus, Palestine, were allocated by class to intervention or wait-list control conditions. Standardized measures assessed trauma exposure,…

  6. Effect of Probiotics on Glycemic Control: A Systematic Review and Meta-Analysis of Randomized, Controlled Trials

    PubMed Central

    He, Jie; Chen, Fangyao; Chen, Rongping; Chen, Hong

    2015-01-01

    Background Previous clinical trials indicate that probiotic consumption may improve blood glucose control, however, results from randomized trials on glycemic control have been inconsistent. Objective To investigate the effects of probiotics on glycemic control in a systematic review and meta-analysis of randomized controlled trials. Data Sources PubMed, Embase, Cochrane Library, and Clinicaltrial.gov through October 2014. Data Extraction and Synthesis Two independent reviewers extracted relevant data and assessed study quality and risk of bias. Data were pooled using a random-effects model and expressed as mean differences (MD) with 95% CI. Heterogeneity was assessed (Cochran Q-statistic) and quantified (I2). Results Seventeen randomized controlled trials were included, in which 17 fasting blood glucose (n = 1105), 11 fasting plasma insulin (n = 788), 8 homeostasis model assessment of insulin resistance (n = 635) comparisons were reported. Probiotic consumption, compared with placebo, significantly reduced fasting glucose (MD = -0.31 mmol/L; 95% CI 0.56, 0.06; p = 0.02), fasting plasma insulin (MD = -1.29 μU/mL; 95% CI -2.17, -0.41; p = 0.004), and HOMA-IR (MD = 0.48; 95% CI -0.83, -0.13; p = 0.007). Conclusions Probiotic consumption may improve glycemic control modestly. Modification of gut microbiota by probiotic supplementation may be a method for preventing and control hyperglycemia in clinical practice. PMID:26161741

  7. Rigorous Program Evaluations on a Budget: How Low-Cost Randomized Controlled Trials Are Possible in Many Areas of Social Policy

    ERIC Educational Resources Information Center

    Coalition for Evidence-Based Policy, 2012

    2012-01-01

    The increasing ability of social policy researchers to conduct randomized controlled trials (RCTs) at low cost could revolutionize the field of performance-based government. RCTs are widely judged to be the most credible method of evaluating whether a social program is effective, overcoming the demonstrated inability of other, more common methods…

  8. Medical Students' and Tutors' Experiences of Directed and Self-Directed Learning Programs in Evidence-Based Medicine: A Qualitative Evaluation Accompanying a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Bradley, Peter; Oterholt, Christina; Nordheim, Lena; Bjorndal, Arild

    2005-01-01

    This qualitative study aims to interpret the results of a randomized controlled trial comparing two educational programs (directed learning and self-directed learning) in evidence-based medicine (EBM) for medical students at the University of Oslo from 2002 to 2003. There is currently very little comparative educational research in this field. In…

  9. Acupuncture for vascular mild cognitive impairment: a systematic review of randomised controlled trials

    PubMed Central

    Cao, Huijuan; Wang, Yuyi; Chang, Dennis; Zhou, Li; Liu, Jianping

    2013-01-01

    Background Vascular mild cognitive impairment (VMCI) is the most common type of vascular cognitive impairment induced by cerebrovascular disease. No effective medicines are currently available for VMCI. Objective To assess the effectiveness and safety of acupuncture for VMCI. Methods Seven electronic databases were searched for randomised controlled trials which investigated the effects of acupuncture compared with no treatment, placebo or conventional therapies on cognitive function or other clinical outcomes in patients with VMCI. The quality of the trials selected was evaluated according to the ‘risk of bias’ assessment provided by the Cochrane Handbook for Systematic Reviews of Interventions. RevMan V.5.1 software was employed for data analysis. Results Twelve trials with 691 participants were included. The methodological quality of all included trials was unclear and/or they had a high risk of bias. Meta-analysis showed acupuncture in conjunction with other therapies could significantly improve Mini-Mental State Examination scores (mean difference 1.99, 95% CI 1.09 to 2.88, random model, p<0.0001, 6 trials). No included trials mentioned any adverse events of the treatment. Conclusions The current clinical evidence is not of sufficient quality for wider application of acupuncture to be recommended for the treatment of VMCI, and further large, rigorously designed trials are warranted. PMID:24123487

  10. Bringing Buprenorphine-Naloxone Detoxification to Community Treatment Providers: The NIDA Clinical Trials Network Field Experience

    PubMed Central

    Amass, Leslie; Ling, Walter; Freese, Thomas E.; Reiber, Chris; Annon, Jeffrey J.; Cohen, Allan J.; M.F.T.; McCarty, Dennis; Reid, Malcolm S.; Brown, Lawrence S.; Clark, Cynthia; Ziedonis, Douglas M.; Krejci, Jonathan; Stine, Susan; Winhusen, Theresa; Brigham, Greg; Babcock, Dean; L.C.S.W.; Muir, Joan A.; Buchan, Betty J.; Horton, Terry

    2005-01-01

    In October 2002, the U.S. Food and Drug Administration approved buprenorphine-naloxone (Suboxone®) sublingual tablets as an opioid dependence treatment available for use outside traditionally licensed opioid treatment programs. The NIDA Center for Clinical Trials Network (CTN) sponsored two clinical trials assessing buprenorphine-naloxone for short-term opioid detoxification. These trials provided an unprecedented field test of its use in twelve diverse community-based treatment programs. Opioid-dependent men and women were randomized to a thirteen-day buprenorphine-naloxone taper regimen for short-term opioid detoxification. The 234 buprenorphine-naloxone patients averaged 37 years old and used mostly intravenous heroin. Direct and rapid induction onto buprenorphine-naloxone was safe and well tolerated. Most patients (83%) received 8 mg buprenorphine-2 mg naloxone on the first day and 90% successfully completed induction and reached a target dose of 16mg buprenorphine-4 mg naloxone in three days. Medication compliance and treatment engagement was high. An average of 81% of available doses was ingested, and 68% of patients completed the detoxification. Most (80.3%) patients received some ancillary medications with an average of 2.3 withdrawal symptoms treated. The safety profile of buprenorphine-naloxone was excellent. Of eighteen serious adverse events reported, only one was possibly related to buprenorphine-naloxone. All providers successfully integrated buprenorphine-naloxone into their existing treatment milieus. Overall, data from the CTN field experience suggest that buprenorphine-naloxone is practical and safe for use in diverse community treatment settings, including those with minimal experience providing opioid-based pharmacotherapy and/or medical detoxification for opioid dependence. PMID:15204675

  11. The Future of Field Trials in Europe: Establishing a Network Beyond Boundaries.

    PubMed

    Stützel, Hartmut; Brüggemann, Nicolas; Inzé, Dirk

    2016-02-01

    We propose the establishment of a European Consortium for Open Field Experimentation (ECOFE) that will allow easy access of European plant and soil scientists to experimental field stations that cover all major climatological regions. Coordination and quality control of data extraction and management systems will greatly impact on our ability to cope with grand challenges such as climate change and food security. PMID:26776473

  12. Primary prevention of skin dysplasia in renal transplant recipients with photodynamic therapy: a randomized controlled trial.

    PubMed

    Togsverd-Bo, K; Omland, S H; Wulf, H C; Sørensen, S S; Haedersdal, M

    2015-11-01

    Organ transplant recipients (OTRs) are at high risk of developing cutaneous squamous cell carcinoma (SCC); prevention includes early treatment of premalignant actinic keratosis (AK). Photodynamic therapy (PDT) is a noninvasive field therapy that reduces new AKs in patients with existing AK and delays SCC development in mice. We investigated the effect of repeated PDT over 5 years for primary prophylaxis of skin dysplasia. These data represent an interim analysis of an on-going randomized controlled trial. During 2008-2011, 25 renal transplant recipients with clinically normal skin were randomized to split-side PDT of the face, forearm and hand, the contralateral side serving as untreated control. Patients received PDT on inclusion and at 6-monthly intervals for 5 years. Blinded evaluation was performed at each visit. We found that prophylactic PDT significantly delayed onset of AK compared with untreated skin, p = 0.020. At 3-year follow-up, we observed AK in 63% of patients in untreated skin areas compared with 28% of patients in PDT-treated skin, with a total number of cumulated AKs in untreated skin (n = 43) compared with PDT-treated skin (n = 8), p = 0.005. These preliminary data indicate a novel approach to early prevention of skin dysplasia that may reduce morbidity from multiple AKs and SCCs in OTR. PMID:26018207

  13. Guest Molecule Exchange Kinetics for the 2012 Ignik Sikumi Gas Hydrate Field Trial

    SciTech Connect

    White, Mark D.; Lee, Won Suk

    2014-05-14

    A commercially viable technology for producing methane from natural gas hydrate reservoirs remains elusive. Short-term depressurization field tests have demonstrated the potential for producing natural gas via dissociation of the clathrate structure, but the long-term performance of the depressurization technology ultimately requires a heat source to sustain the dissociation. A decade of laboratory experiments and theoretical studies have demonstrated the exchange of pure CO2 and N2-CO2 mixtures with CH4 in sI gas hydrates, yielding critical information about molecular mechanisms, recoveries, and exchange kinetics. Findings indicated the potential for producing natural gas with little to no production of water and rapid exchange kinetics, generating sufficient interest in the guest-molecule exchange technology for a field test. In 2012 the U.S. DOE/NETL, ConocoPhillips Company, and Japan Oil, Gas and Metals National Corporation jointly sponsored the first field trial of injecting a mixture of N2-CO2 into a CH4-hydrate bearing formation beneath the permafrost on the Alaska North Slope. Known as the Ignik Sikumi #1 Gas Hydrate Field Trial, this experiment involved three stages: 1) the injection of a N2-CO2 mixture into a targeted hydrate-bearing layer, 2) a 4-day pressurized soaking period, and 3) a sustained depressurization and fluid production period. Data collected during the three stages of the field trial were made available after an extensive quality check. These data included continuous temperature and pressure logs, injected and recovered fluid compositions and volumes. The Ignik Sikumi #1 data set is extensive, but contains no direct evidence of the guest-molecule exchange process. This investigation is directed at using numerical simulation to provide an interpretation of the collected data. A numerical simulator, STOMP-HYDT-KE, was recently completed that solves conservation equations for energy, water, mobile fluid guest molecules, and hydrate guest

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

    NASA Technical Reports Server (NTRS)

    Langhans, Robert W.

    1997-01-01

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

  15. Raman distributed temperature sensor for oil leakage detection in soil: a field trial and future trends

    NASA Astrophysics Data System (ADS)

    Signorini, Alessandro; Nannipieri, Tiziano; Gabella, Luca; Di Pasquale, Fabrizio; Latini, Gilberto; Ripari, Daniele

    2014-05-01

    In this paper we perform field validation of distributed Raman temperature sensing (RDTS) for oil leakage detection in soil. The capability of the distributed Raman sensor in detecting and locating, with high accuracy and spatial resolution, drop leakages in soil is demonstrated through a water leakage simulation in a field trial. The future trends and the high potential of the Raman DTS technology for oil and gas leakage detection in long pipelines is then outlined in this paper by reporting lab experiments demonstrating accurate meter scale temperature measurement over more than 50 km of standard single mode fiber. The proposed solution, based on distributed Simplex coding techniques, can be competitive in terms of cost and performance with respect to other distributed sensing technologies.

  16. Attentive scanning behavior drives one-trial potentiation of hippocampal place fields.

    PubMed

    Monaco, Joseph D; Rao, Geeta; Roth, Eric D; Knierim, James J

    2014-05-01

    The hippocampus is thought to have a critical role in episodic memory by incorporating the sensory input of an experience onto a spatial framework embodied by place cells. Although the formation and stability of place fields requires exploration, the interaction between discrete exploratory behaviors and the specific, immediate and persistent modifications of neural representations required by episodic memory has not been established. We recorded place cells in rats and found that increased neural activity during exploratory head-scanning behaviors predicted the formation and potentiation of place fields on the next pass through that location, regardless of environmental familiarity and across multiple testing days. These results strongly suggest that, during the attentive behaviors that punctuate exploration, place cell activity mediates the one-trial encoding of ongoing experiences necessary for episodic memory.

  17. On the "Optimal" Choice of Trial Functions for Modelling Potential Fields

    NASA Astrophysics Data System (ADS)

    Michel, Volker

    2015-04-01

    There are many trial functions (e.g. on the sphere) available which can be used for the modelling of a potential field. Among them are orthogonal polynomials such as spherical harmonics and radial basis functions such as spline or wavelet basis functions. Their pros and cons have been widely discussed in the last decades. We present an algorithm, the Regularized Functional Matching Pursuit (RFMP), which is able to choose trial functions of different kinds in order to combine them to a stable approximation of a potential field. One main advantage of the RFMP is that the constructed approximation inherits the advantages of the different basis systems. By including spherical harmonics, coarse global structures can be represented in a sparse way. However, the additional use of spline basis functions allows a stable handling of scattered data grids. Furthermore, the inclusion of wavelets and scaling functions yields a multiscale analysis of the potential. In addition, ill-posed inverse problems (like a downward continuation or the inverse gravimetric problem) can be regularized with the algorithm. We show some numerical examples to demonstrate the possibilities which the RFMP provides.

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

    NASA Astrophysics Data System (ADS)

    Gula, Taras; Hoessler, Carolyn; Maciejewski, Wes

    2015-11-01

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

  19. Transcutaneous electrical nerve stimulation as adjunct to primary care management for tennis elbow: pragmatic randomised controlled trial (TATE trial)

    PubMed Central

    Lewis, A Martyn; Sim, Julius; Mallen, Christian D; Mason, Elizabeth E; Hay, Elaine M; van der Windt, Daniëlle A

    2013-01-01

    Objective To investigate the effectiveness of supplementing information and advice on analgesia and exercise from a general practitioner with transcutaneous electrical nerve stimulation (TENS) as a non-drug form of analgesia to reduce pain intensity in patients with tennis elbow. Design Pragmatic randomised controlled trial in primary care. Setting and 38 general practices in the West Midlands, UK. Participants 241 adults consulting with a first or new (no consultation in previous six months) clinical diagnosis of tennis elbow. Interventions Participants were randomly allocated to either primary care management alone, consisting of a consultation with a general practitioner followed by information and advice on exercises, or primary care management plus TENS to be used once a day for 45 minutes over six weeks (or until symptom resolution) for pain relief. Outcome measures The primary outcome was self reported intensity of elbow pain (0-10 rating scale) at six weeks. Primary and secondary outcomes were measured at baseline and at six weeks, six months, and 12 months by postal questionnaire. Analysis was by intention to treat. Results 121 participants were randomised to primary care management plus TENS and 120 to primary care management only (first episode, n=197 (82%); duration <1-3 months, n=138 (57%)). Adherence to exercise and TENS recommendations reported at six weeks was low; only 42 participants in the primary care management plus TENS group met a priori defined adherence criteria. Both intervention groups showed large improvements in pain and secondary outcomes, especially during the first six weeks of follow-up. However, no clinically or statistically significant differences were seen between groups at any follow-up timepoint. At the primary endpoint (six weeks), the between group difference in improvement of pain was −0.33 (95% confidence interval −0.96 to 0.31; P=0.31) in favour of the primary care management only group, with adjustment for age, sex

  20. A new framework for interpreting the outcomes of imperfectly blinded controlled clinical trials.

    PubMed

    Arandjelović, Ognjen

    2012-01-01

    It is well known that the outcome of an intervention is affected both by the inherent effects of the intervention and the patient's expectations. For this reason in comparative clinical trials an effort is made to conceal the nature of the administered intervention from the participants in the trial i.e. to blind the trial. Yet, in practice perfect blinding is impossible to ensure or even verify post hoc. The current clinical standard is to follow up the trial with an auxiliary questionnaire, which allows trial participants to express in closed form their belief concerning the intervention, i.e. trial group assignment (treatment or control). Auxiliary questionnaire responses are then used to compute the extent of blinding in the trial in the form of a blinding index. If the estimated extent of blinding exceeds a particular threshold the trial is deemed sufficiently blinded; otherwise, the strength of evidence of the trial is brought into question. This may necessitate that the trial is repeated. In this paper we make several contributions. Firstly, we identify a series of problems of the aforesaid clinical practice and discuss them in context of the most commonly used blinding indexes. Secondly, we formulate a novel approach for handling imperfectly blinded trials. We adopt a feedback questionnaire of the same form as that which is currently in use, but interpret the collected data using a novel statistical method, significantly different from that proposed in the previous work. Unlike the previously proposed approaches, our method is void of any ad hoc free parameters and robust to small changes in the participants' feedback responses. Our method also does not discard any data and is not predicated on any strong assumptions used to interpret participants' feedback. The key idea behind the present method is that it is meaningful to compare only the corresponding treatment and control participant sub-groups, that is, sub-groups matched by their auxiliary responses

  1. Evaluation of chemical controls and entomopathogenic nematodes for control of Phyllophaga white grubs in a Fraser fir production field.

    PubMed

    Liesch, P J; Williamson, R C

    2010-12-01

    The results of 2 yr of field trials evaluating various chemical and biological controls of Phyllophaga anxia (LeConte) white grubs in a Fraser fir [Abies fraseri (Pursh) Poir] Christmas tree production field are reported here. Chemical insecticides evaluated included bifenthrin, chlorantraniliprole, thiamethoxam, and time-released imidacloprid tablets (Coretect, Bayer CropScience, Research Triangle Park, NC). Entomopathogenic nematodes evaluated included Heterorhabditis bacteriophora (Poinar) and Steinernema carpocapsae (Weiser). Overall, the chemical controls provided the best root protection and grub control. Targeted treatments of an insecticide in the root zone may provide adequate tree protection and can be a way to reduce overall insecticide input compared with banded sprays. The nematode H. bacteriophora provided limited root protection and grub control, whereas S. carpocapsae did not provide effective control. Differences in efficacy and persistence of the two entomopathogenic nematode species can be attributed to the biology and environmental preferences of these organisms.

  2. Veterinary homeopathy: systematic review of medical conditions studied by randomised placebo-controlled trials.

    PubMed

    Mathie, Robert T; Clausen, Jürgen

    2014-10-18

    A systematic review of randomised controlled trials (RCTs) of veterinary homeopathy has not previously been undertaken. Using Cochrane methods, this review aims to assess risk of bias and to quantify the effect size of homeopathic intervention compared with placebo for each eligible peer-reviewed trial. Judgement in seven assessment domains enabled a trial's risk of bias to be designated as low, unclear or high. A trial was judged to comprise reliable evidence if its risk of bias was low or was unclear in specified domains. A trial was considered to be free of vested interest if it was not funded by a homeopathic pharmacy. The 18 eligible RCTs were disparate in nature, representing four species and 11 different medical conditions. Reliable evidence, free from vested interest, was identified in two trials: homeopathic Coli had a prophylactic effect on porcine diarrhoea (odds ratio 3.89, 95 per cent confidence interval [CI], 1.19 to 12.68, P=0.02); and individualised homeopathic treatment did not have a more beneficial effect on bovine mastitis than placebo intervention (standardised mean difference -0.31, 95 per cent CI, -0.97 to 0.34, P=0.35). Mixed findings from the only two placebo-controlled RCTs that had suitably reliable evidence precluded generalisable conclusions about the efficacy of any particular homeopathic medicine or the impact of individualised homeopathic intervention on any given medical condition in animals.

  3. Role of technology in supporting quality control and treatment fidelity in a family caregiver clinical trial.

    PubMed

    Farran, Carol J; Etkin, Caryn D; McCann, Judith J; Paun, Olimpia; Eisenstein, Amy R; Wilbur, Joellen

    2011-11-01

    This article describes how a family caregiver lifestyle physical activity clinical trial uses research technology to enhance quality control and treatment fidelity. This trial uses a range of Internet, Blaise(®) Windows-based software and Echo Server technologies to support quality control issues, such as data collection, data entry, and study management advocated by the clinical trials literature, and to ensure treatment fidelity concerning intervention implementation (i.e., design, training, delivery, receipt, and enactment) as proposed by the National Institutes of Health Behavior Change Consortium. All research staff are trained to use these technologies. Strengths of this technological approach to support quality control and treatment fidelity include the comprehensive plan, involvement of all staff, and ability to maintain accurate and timely data. Limitations include the upfront time and costs for developing and testing these technological methods, and having support staff readily available to address technological issues if they occur.

  4. Outcome measures for vulval skin conditions: a systematic review of randomized controlled trials.

    PubMed

    Simpson, R C; Thomas, K S; Murphy, R

    2013-09-01

    Symptoms and signs of vulval skin disorders are common. These conditions can have a considerable impact on quality of life, restricting physical activities and causing difficulty in everyday activities and may also affect social, psychosexual and psychological well-being. There are no standardized measures routinely used to assess the impact of vulval disease on daily life. To report outcome measures used in clinically based randomized controlled trials (RCTs) investigating therapeutic interventions in vulval disease. The Medline, EMBASE and CENTRAL databases were searched to identify RCTs of vulval skin conditions written in English. Studies with laboratory tests or survival rates as the primary outcome, or those investigating menopausal symptoms or infections were excluded. Twenty-eight published RCTs were included. The vulval conditions represented were vulvodynia (n = 14), lichen sclerosus (n = 9), vulval intraepithelial neoplasia (n = 2), vulval pruritus (n = 2) and lichen planus (n = 1). The 28 RCTs measured 25 different outcomes, using 49 different scales. The method of outcome assessment was lacking on nine occasions. Only 21% (six of 28) of included trials had a clearly stated primary outcome. Patient-reported outcomes were more commonly reported than clinician-related outcome measures. The most commonly reported patient-rated outcome measure was a reduction in pain (measured 15 times) and an overall improvement in symptoms using a patient global assessment (measured 11 times). The most commonly reported clinician-rated outcome was an overall assessment of the appearance of affected sites (measured 13 times). There were no agreed standard scales used for the global assessments. Only nine of the recorded outcome measure tools were designed to assess vulval disease or sexual functioning, the remainder were general measures. There is heterogeneity in the outcome measures used when reporting therapeutic interventions in vulval disease. This field of

  5. Progesterone Receptor Modulator for Emergency Contraception: A Randomized Controlled Trial

    PubMed Central

    Creinin, Mitchell D.; Schlaff, William; Archer, David F.; Wan, Livia; Frezieres, Ron; Thomas, Michael; Rosenberg, Michael; Higgins, James

    2010-01-01

    Objective Compare the efficacy and adverse effects of CDB-2914, a new progesterone receptor modulator, to levonorgestrel for emergency contraception. Methods We performed a randomized, double-blinded noninferiority trial, enrolling healthy women seeking emergency contraception within 72 hours of unprotected intercourse. Participants were randomly assigned to receive a single dose of 50 mg of CDB-2914, plus a placebo 12 hours later or two doses of 0.75 mg of levonorgestrel taken 12 hours apart. Follow-up was scheduled 5 to 7 days after the expected onset of the next menstrual period. Posttreatment pregnancy was established by a positive urine test at follow-up and confirmed by quantitative serum β-hCG. Daily diaries were used from the time of emergency contraception use until next menses to record adverse effects and sexual activity. Results Product efficacy was evaluable in 775 of CDB-2914 users and 774 of levonorgestrel users. Pregnancies occurred in 7 (0.9%, 95% confidence interval 0.2–1.6%) and 13 (1.7%, 95% confidence interval 0.8–2.6%) women, respectively. Based on the estimated cycle day of unprotected intercourse, 85% and 69% of anticipated pregnancies, respectively, were averted. Nausea was reported by a somewhat greater percentage of CDB-2914 than levonorgestrel users (29% compared with 24%, P=.03), but the distribution of other adverse effects was similar in both groups. Women in both groups experienced considerable variation in menstrual cycle length as compared with their reported individual normal cycle lengths. Conclusion CDB-2914 is at least as effective as levonorgestrel in preventing pregnancies after unprotected intercourse and has a similar side effect profile. PMID:17077229

  6. Chinese Obstetrics & Gynecology journal club: a randomised controlled trial

    PubMed Central

    Tsui, Ilene K; Dodson, William C; Kunselman, Allen R; Kuang, Hongying; Han, Feng-Juan; Legro, Richard S; Wu, Xiao-Ke

    2016-01-01

    Objectives To assess whether a journal club model could improve comprehension and written and spoken medical English in a population of Chinese medical professionals. Setting and participants The study population consisted of 52 medical professionals who were residents or postgraduate master or PhD students in the Department of Obstetrics and Gynecology, Heilongjiang University of Chinese Medicine, China. Intervention After a three-part baseline examination to assess medical English comprehension, participants were randomised to either (1) an intensive journal club treatment arm or (2) a self-study group. At the conclusion of the 8-week intervention participants (n=52) were re-tested with new questions. Outcome measures The primary outcome was the change in score on a multiple choice examination. Secondary outcomes included change in scores on written and oral examinations which were modelled on the Test of English as a Foreign Language (TOEFL). Results Both groups had improved scores on the multiple choice examination without a statistically significant difference between them (90% power). However, there was a statistically significant difference between the groups in mean improvement in scores for both written (95% CI 1.1 to 5.0; p=0.003) and spoken English (95% CI 0.06 to 3.7; p=0.04) favouring the journal club intervention. Conclusions Interacting with colleagues and an English-speaking facilitator in a journal club improved both written and spoken medical English in Chinese medical professionals. Journal clubs may be suitable for use as a self-sustainable teaching model to improve fluency in medical English in foreign medical professionals. Trial registration number NCT01844609. PMID:26823180

  7. Surrogate endpoints for overall survival in metastatic melanoma: a meta-analysis of randomised controlled trials

    PubMed Central

    Flaherty, Keith T; Hennig, Michael; Lee, Sandra J; Ascierto, Paolo A; Dummer, Reinhard; Eggermont, Alexander M M; Hauschild, Axel; Kefford, Richard; Kirkwood, John M; Long, Georgina V; Lorigan, Paul; Mackensen, Andreas; McArthur, Grant; O'Day, Steven; Patel, Poulam M; Robert, Caroline; Schadendorf, Dirk

    2015-01-01

    Summary Background Recent phase 3 trials have shown an overall survival benefit in metastatic melanoma. We aimed to assess whether progression-free survival (PFS) could be regarded as a reliable surrogate for overall survival through a meta-analysis of randomised trials. Methods We systematically reviewed randomised trials comparing treatment regimens in metastatic melanoma that included dacarbazine as the control arm, and which reported both PFS and overall survival with a standard hazard ratio (HR). We correlated HRs for overall survival and PFS, weighted by sample size or by precision of the HR estimate, assuming fixed and random effects. We did sensitivity analyses according to presence of crossover, trial size, and dacarbazine dose. Findings After screening 1649 reports and meeting abstracts published before Sept 8, 2013, we identified 12 eligible randomised trials that enrolled 4416 patients with metastatic melanoma. Irrespective of weighting strategy, we noted a strong correlation between the treatment effects for PFS and overall survival, which seemed independent of treatment type. Pearson correlation coefficients were 0.71 (95% CI 0.29–0.90) with a random-effects assumption, 0.85 (0.59–0.95) with a fixed-effects assumption, and 0.89 (0.68–0.97) with sample-size weighting. For nine trials without crossover, the correlation coefficient was 0.96 (0.81–0.99), which decreased to 0.93 (0.74–0.98) when two additional trials with less than 50% crossover were included. Inclusion of mature follow-up data after at least 50% crossover (in vemurafenib and dabrafenib phase 3 trials) weakened the PFS to overall survival correlation (0.55, 0.03–0.84). Inclusion of trials with no or little crossover with the random-effects assumption yielded a conservative statement of the PFS to overall survival correlation of 0.85 (0.51–0.96). Interpretation PFS can be regarded as a robust surrogate for overall survival in dacarbazine-controlled randomised trials of

  8. Controlling ecological bias in evidence synthesis of trials reporting on collapsed and overlapping covariate categories.

    PubMed

    Govan, L; Ades, A E; Weir, C J; Welton, N J; Langhorne, P

    2010-05-30

    Meta-analysis of randomized controlled trials based on aggregated data is vulnerable to ecological bias if trial results are pooled over covariates that influence the outcome variable, even when the covariate does not modify the treatment effect, or is not associated with the treatment. This paper shows how, when trial results are aggregated over different levels of covariates, the within-study covariate distribution, and the effects of both covariates and treatments can be simultaneously estimated, and ecological bias reduced. Bayesian Markov chain Monte Carlo methods are used. The method is applied to a mixed treatment comparison evidence synthesis of six alternative approaches to post-stroke inpatient care. Results are compared with a model using only the stratified covariate data available, where each stratum is treated as a separate trial, and a model using fully aggregated data, where no covariate data are used. PMID:20191599

  9. Patient-controlled oral analgesia versus nurse-controlled parenteral analgesia after caesarean section: a randomised controlled trial.

    PubMed

    Bonnal, A; Dehon, A; Nagot, N; Macioce, V; Nogue, E; Morau, E

    2016-05-01

    We assessed the effectiveness of early patient-controlled oral analgesia compared with parenteral analgesia in a randomised controlled non-inferiority trial of women undergoing elective caesarean section under regional anaesthesia. Seventy-seven women received multimodal paracetamol, ketoprofen and morphine analgesia. The woman having patient-controlled oral analgesia were administered four pillboxes on the postnatal ward containing tablets and instructions for self-medication, the first at 7 h after the spinal injection and then three more at 12-hourly intervals. Pain at rest and on movement was evaluated using an 11-point verbal rating scale at 2 h and then at 6-hourly intervals for 48 h. The pre-defined non-inferiority limit for the difference in mean pain scores (patient-controlled oral analgesia minus parenteral) was one. The one-sided 95% CI of the difference in mean pain scores was significantly lower than one at all time-points at rest and on movement, demonstrating non-inferiority of patient-controlled oral analgesia. More women used morphine in the patient-controlled oral analgesia group (22 (58%)) than in the parenteral group (9 (23%); p = 0.002). The median (IQR [range]) number of morphine doses in the patient-controlled oral analgesia group was 2 (1-3 [1-7]) compared with 1 (1-1 [1-2]); p = 0.006) in the parenteral group. Minor drug errors or omissions were identified in five (13%) women receiving patient-controlled oral analgesia. Pruritus was more frequent in the patient-controlled oral analgesia group (14 (37%) vs 6 (15%) respectively; p = 0.03), but no differences were noted for other adverse events and maternal satisfaction. After elective caesarean section, early patient-controlled oral analgesia is non-inferior to standard parenteral analgesia for pain management, and can be one of the steps of an enhanced recovery process. PMID:26931110

  10. Implementing lessons learned from previous bronchial biopsy trials in a new randomized controlled COPD biopsy trial with roflumilast

    PubMed Central

    2014-01-01

    Background Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease mediated by an array of inflammatory cells and mediators, but above all, CD8+ T-lymphocytes, macrophages and neutrophils are important players in disease pathogenesis. Roflumilast, a first-in-class, potent and selective phosphodiesterase 4 (PDE4) inhibitor, reduces the rate of exacerbations in patients with a high risk of future exacerbations and has been shown to reduce inflammatory cells and mediators in induced sputum, a surrogate of airway inflammation. However, these anti-inflammatory effects are yet to be confirmed in another robust study directly assessing inflammatory markers in bronchial sub-mucosa. Methods/Design An international, 16-week, randomized, double-blind, placebo-controlled, parallel-group study investigating the effects of roflumilast 500 μg once-daily versus placebo on inflammatory parameters in bronchial biopsy tissue specimens, sputum and blood serum. One hundred and fifty patients with COPD and chronic bronchitis for at least 12 months will be recruited into the study and randomized in a 1:1 ratio to receive either roflumilast or placebo. The primary endpoint will be the number of CD8+ cells (cell counts per mm2) in bronchial biopsy tissue specimens (sub-mucosa) and the key secondary endpoint will be the number of CD68+ cells (cell counts per mm2), assessed by indirect immunohistochemistry. Discussion It is hypothesized that treatment with roflumilast reduces the characteristic inflammation found in the airways of patients with moderate-to-severe COPD, compared with placebo. The design of the present study has built on the work of previous bronchial biopsy studies available in the literature. It is hoped that it will reveal the cellular mechanisms underlying the anti-inflammatory effects of roflumilast and identify potentially important biomarkers and other surrogate endpoints in patients with COPD. The design and rationale for this trial are

  11. Sutureless Adult Voluntary Male Circumcision with Topical Anesthetic: A Randomized Field Trial of Unicirc, a Single-Use Surgical Instrument

    PubMed Central

    2016-01-01

    Introduction The World Health Organization has solicited rapid and minimally invasive techniques to facilitate scale-up of voluntary medical male circumcision (VMMC). Study design Non-blinded randomized controlled field trial with 2:1 allocation ratio. Participants 75 adult male volunteers. Setting Outpatient primary care clinic. Intervention Open surgical circumcision under local anesthetic with suturing vs. Unicirc disposable instrument under topical anesthetic and wound sealing with cyanoacrylate tissue adhesive. Primary Outcome Intraoperative duration. Secondary Outcomes Intraoperative and postoperative pain; adverse events; time to healing; patient satisfaction; cosmetic result. Results The intraoperative time was less with the Unicirc technique (median 12 vs. 25 min, p < 0.001). Wound healing and cosmetic results were superior in the Unicirc group. Adverse events were similar in both groups. Conclusions VMMC with Unicirc under topical anesthetic and wound sealing with cyanoacrylate tissue adhesive is rapid, heals by primary intention with superior cosmetic results, and is potentially safer and more cost-effective than open surgical VMMC. Trial Registration Clinicaltrials.gov NCT02443792 PMID:27299735

  12. A large-scale field trial of malathion as an insecticide for antimalarial work in southern Uganda

    PubMed Central

    Najera, J. A.; Shidrawi, G. R.; Gibson, F. D.; Stafford, J. S.

    1967-01-01

    Malathion shows promise as a substitute for chlorinated-hydrocarbon insecticides in the control of malaria whenever the latter are unsuitable because of Anopheles resistance or other reasons. A field trial of malathion was carried out in 1963-64, covering an area of about 500 km2 with a population of about 26 000, in Masaka District, southern Uganda. All houses and animal shelters were sprayed with malathion at 2 g/m2 at roughly 4-month intervals. The average combined densities of the females of the two main malaria vectors, Anopheles funestus and An. gambiae, fell from an average of 66 per shelter per day in a pre-trial survey in 1960-61 to 0.0011 at the end of 1964 in the sprayed area; no significant changes were noted in unsprayed comparison areas. The transmission of the infection in humans was apparently interrupted when allowance was made for imported cases. The presence of unsprayed surfaces in houses which had recently been built or altered interfered somewhat with complete coverage. Case detection was reliable and achieved excellent coverage. No toxic effects of malathion in humans were noted, while the effect on mosquitos was considerable even in the absence of direct contact. This effect of malathion lasted for a considerably shorter period of time in houses roofed with corrugated iron than with thatch; this should be borne in mind in the design of spraying programmes. PMID:5299860

  13. Benchmarking Controlled Trial--a novel concept covering all observational effectiveness studies.

    PubMed

    Malmivaara, Antti

    2015-06-01

    The Benchmarking Controlled Trial (BCT) is a novel concept which covers all observational studies aiming to assess effectiveness. BCTs provide evidence of the comparative effectiveness between health service providers, and of effectiveness due to particular features of the health and social care systems. BCTs complement randomized controlled trials (RCTs) as the sources of evidence on effectiveness. This paper presents a definition of the BCT; compares the position of BCTs in assessing effectiveness with that of RCTs; presents a checklist for assessing methodological validity of a BCT; and pilot-tests the checklist with BCTs published recently in the leading medical journals.

  14. Behavior Therapy for Pediatric Trichotillomania: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Franklin, Martin E.; Edson, Aubrey L.; Ledley, Deborah A.; Cahill, Shawn P.

    2011-01-01

    Objective: To examine the efficacy and durability of a behavioral therapy (BT) protocol for pediatric TTM compared with a minimal attention control (MAC) condition. It was hypothesized that the BT condition would be superior to MAC at the end of acute treatment, and would also demonstrate durability of gains through the maintenance treatment…

  15. Organic weed control for cantaloupe methods comparison trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Effective weed control is needed for successful melon production. Synthetic herbicides that are available for non-organic melon production cannot be used in organic production. In addition to organic producers' needs, herbicide use is not always practical in many garden situations, whether organic o...

  16. Cognitive behavioral therapy for orthodontic pain control: a randomized trial.

    PubMed

    Wang, J; Jian, F; Chen, J; Ye, N S; Huang, Y H; Wang, S; Huang, R H; Pei, J; Liu, P; Zhang, L; Zhao, Z H; Chen, Q M; Lai, W L; Lin, Y F

    2012-06-01

    The objective of this study was to evaluate the efficacy of cognitive behavioral therapy intervention for patients who experienced pain during orthodontic treatment. The baseline characteristics were assessed via questionnaires and oral examinations. Four hundred and fifty eligible individuals were recruited and randomized by computer-generated block randomization into three groups: cognitive behavioral therapy intervention (n = 150), ibuprofen intervention (n = 150), and no intervention (control; n = 150). Primary outcomes were the change from baseline in pain intensity measured with 100-mm Visual Analog Scale (VAS) scores at 1, 2, 3, 7, 14, and 30 days after initial archwire placement. Outcomes assessment was blinded and followed the intention-to-treat principle. One hundred forty-three (95.30%), 145 (96.70%), and 141 (94.00%) individuals in the cognitive behavioral therapy, the ibuprofen, and the control groups, respectively, completed the one-month follow-up evaluations. Those in the cognitive behavioral therapy group showed a greater decrease in mean VAS scores than did those in the control group over the previous five time-points (p < 0.001). Cognitive behavioral therapy was shown to be effective in pain control during the initial stage of orthodontic treatment. The study registration number was ChiCTR-TRC-00000556.

  17. Does Playworks Work? Findings from a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    James-Burdumy, Susanne; Bleeker, Martha; Beyler, Nicholas; London, Rebecca A.; Westrich, Lisa; Stokes-Guinan, Katie; Castrechini, Sebastian

    2013-01-01

    Most school principals believe recess has a positive impact on the development of students' social skills and academic achievement. Research also suggests that physical activity and play during recess may be linked to improvements in both academic and prosocial behaviors (Centers for Disease Control and Prevention 2010). Recess, however, has been…

  18. An analysis of two island groups as potential sites for trials of transgenic mosquitoes for malaria control

    PubMed Central

    Marsden, Clare D; Cornel, Anthony; Lee, Yoosook; Sanford, Michelle R; Norris, Laura C; Goodell, Parker B; Nieman, Catelyn C; Han, Sarah; Rodrigues, Amabelia; Denis, Joao; Ouledi, Ahmed; Lanzaro, Gregory C

    2013-01-01

    Considerable technological advances have been made towards the generation of genetically modified mosquitoes for vector control. In contrast, less progress has been made towards field evaluations of transformed mosquitoes which are critical for evaluating the success of, and hazards associated with, genetic modification. Oceanic islands have been highlighted as potentially the best locations for such trials. However, population genetic studies are necessary to verify isolation. Here, we used a panel of genetic markers to assess for evidence of genetic isolation of two oceanic island populations of the African malaria vector, Anopheles gambiae s.s. We found no evidence of isolation between the Bijagós archipelago and mainland Guinea-Bissau, despite separation by distances beyond the known dispersal capabilities of this taxon. Conversely, the Comoros Islands appear to be genetically isolated from the East African mainland, and thus represent a location worthy of further investigation for field trials. Based on assessments of gene flow within and between the Comoros islands, the island of Grande Comore was found to be genetically isolated from adjacent islands and also exhibited local population structure, indicating that it may be the most suitable site for trials with existing genetic modification technologies. PMID:23789035

  19. Eliminating bias in randomized controlled trials: importance of allocation concealment and masking.

    PubMed

    Viera, Anthony J; Bangdiwala, Shrikant I

    2007-02-01

    Randomization in randomized controlled trials involves more than generation of a random sequence by which to assign subjects. For randomization to be successfully implemented, the randomization sequence must be adequately protected (concealed) so that investigators, involved health care providers, and subjects are not aware of the upcoming assignment. The absence of adequate allocation concealment can lead to selection bias, one of the very problems that randomization was supposed to eliminate. Authors of reports of randomized trials should provide enough details on how allocation concealment was achieved so the reader can determine the likelihood of success. Fortunately, a plan of allocation concealment can always be incorporated into the design of a randomized trial. Certain methods minimize the risk of concealment failing more than others. Keeping knowledge of subjects' assignment after allocation from subjects, investigators/health care providers, or those assessing outcomes is referred to as masking (also known as blinding). The goal of masking is to prevent ascertainment bias. In contrast to allocation concealment, masking cannot always be incorporated into a randomized controlled trial. Both allocation concealment and masking add to the elimination of bias in randomized controlled trials.

  20. Global Postural Reeducation for patients with musculoskeletal conditions: a systematic review of randomized controlled trials

    PubMed Central

    Ferreira, Giovanni E.; Barreto, Rodrigo G. P.; Robinson, Caroline C.; Plentz, Rodrigo D. M.; Silva, Marcelo F.

    2016-01-01

    ABSTRACT Objectives To systematically review randomized controlled trials that assessed the effects of Global Postural Reeducation (GPR) on patient-reported outcomes in conditions of the musculoskeletal system. Method An electronic search of MEDLINE (via PubMed), EMBASE, Cochrane CENTRAL, and SciELO was performed from their inception to June 2015. Randomized controlled trials that analyzed pain and patient-reported outcomes were included in this review. The Cochrane Collaboration’s Risk of Bias Tool was used to evaluate risk of bias, and the quality of evidence was rated following the GRADE approach. There were no language restrictions. Results Eleven trials were included totaling 383 patients. Overall, the trials had high risk of bias. GPR was superior to no treatment but not to other forms of treatment for pain and disability. No placebo-controlled trials were found. Conclusion GPR is not superior to other treatments; however, it is superior to no treatment. Due to the lack of studies, it is unknown if GPR is better than placebo. The quality of the available evidence ranges from low to very low, therefore future studies may change the effect estimates of GPR in musculoskeletal conditions. PMID:27437710

  1. Methods to improve recruitment to randomised controlled trials: Cochrane systematic review and meta-analysis

    PubMed Central

    Treweek, Shaun; Lockhart, Pauline; Pitkethly, Marie; Cook, Jonathan A; Kjeldstrøm, Monica; Johansen, Marit; Taskila, Taina K; Sullivan, Frank M; Wilson, Sue; Jackson, Catherine; Jones, Ritu; Mitchell, Elizabeth D

    2013-01-01

    This review is an abridged version of a Cochrane Review previously published in the Cochrane Database of Systematic Reviews 2010, Issue 4, Art. No.: MR000013 DOI: 10.1002/14651858.MR000013.pub5 (see www.thecochranelibrary.com for information). Cochrane Reviews are regularly updated as new evidence emerges and in response to feedback, and Cochrane Database of Systematic Reviews should be consulted for the most recent version of the review. Objective To identify interventions designed to improve recruitment to randomised controlled trials, and to quantify their effect on trial participation. Design Systematic review. Data sources The Cochrane Methodology Review Group Specialised Register in the Cochrane Library, MEDLINE, EMBASE, ERIC, Science Citation Index, Social Sciences Citation Index, C2-SPECTR, the National Research Register and PubMed. Most searches were undertaken up to 2010; no language restrictions were applied. Study selection Randomised and quasi-randomised controlled trials, including those recruiting to hypothetical studies. Studies on retention strategies, examining ways to increase questionnaire response or evaluating the use of incentives for clinicians were excluded. The study population included any potential trial participant (eg, patient, clinician and member of the public), or individual or group of individuals responsible for trial recruitment (eg, clinicians, researchers and recruitment sites). Two authors independently screened identified studies for eligibility. Results 45 trials with over 43 000 participants were included. Some interventions were effective in increasing recruitment: telephone reminders to non-respondents (risk ratio (RR) 1.66, 95% CI 1.03 to 2.46; two studies, 1058 participants), use of opt-out rather than opt-in procedures for contacting potential participants (RR 1.39, 95% CI 1.06 to 1.84; one study, 152 participants) and open designs where participants know which treatment they are receiving in the trial (RR 1.22, 95

  2. Effect of “collaborative requesting” on consent rate for organ donation: randomised controlled trial (ACRE trial)

    PubMed Central

    2009-01-01

    Objective To determine whether collaborative requesting increases consent for organ donation from the relatives of patients declared dead by criteria for brain stem death. Design Unblinded multicentre randomised controlled trial using a sequential design. Centralised 24 hour telephone randomisation based on randomised permuted blocks of 10. Setting 79 general, neuroscience, and paediatric intensive care units in the United Kingdom. Participants 201 relatives of patients meeting criteria for brain stem death. Relatives were blind to the intervention and to the trial; all other participants were necessarily unblinded. Interventions Collaborative requesting for consent for organ donation by the potential donor’s clinician and a donor transplant coordinator (organ procurement officer) compared with routine requesting by the clinical team alone. Main outcome measure Proportion of relatives consenting to organ donation. Results 101 relatives were randomised to routine requesting and 100 to collaborative requesting. All were analysed on an intention to treat basis. In the routine requesting group, 62 relatives consented to organ donation. In the collaborative requesting group, 57 relatives consented. After correction for the ethnicity, age, and sex of the potential donors the risk adjusted ratio of the odds of consent in the collaborative requesting group relative to the routine group was 0.80 (95% confidence interval 0.43 to 1.53), with a P value of 0.49 adjusted for interim analysis and trial over-running. The conversion rate (donors with consent from whom any organs were retrieved) was 92% (57/62) in the routine requesting group and 79% (45/57) in the collaborative requesting group (P=0.043). There were 140 approaches to relatives in the per protocol analysis, leading to 60.3% (44/73) consent after routine and 67.2% (45/67) after collaborative requesting (risk adjusted odds ratio of consent 1.47, 0.67 to 3.20, P=0.33). Conclusion There is no increase in consent rates

  3. The VITAH Trial Vitamin D supplementation and cardiac autonomic tone in hemodialysis: a blinded, randomized controlled trial

    PubMed Central

    2014-01-01

    Background Patients with end-stage kidney disease (ESKD) have a high rate of mortality and specifically an increased risk of sudden cardiac death (SCD). Impaired cardiac autonomic tone is associated with elevated risk of SCD. Moreover, patients with ESKD are often vitamin D deficient, which we have shown may be linked to autonomic dysfunction in humans. To date, it is not known whether vitamin D supplementation normalizes cardiac autonomic function in the high-risk ESKD population. The VITamin D supplementation and cardiac Autonomic tone in Hemodialysis (VITAH) randomized trial will determine whether intensive vitamin D supplementation therapies improve cardiac autonomic tone to a greater extent than conventional vitamin D supplementation regimens in ESKD patients requiring chronic hemodialysis. Methods/Design A total of 60 subjects with ESKD requiring thrice weekly chronic hemodialysis will be enrolled in this 2x2 crossover, blinded, randomized controlled trial. Following a 4-week washout period from any prior vitamin D therapy, subjects are randomized 1:1 to intensive versus standard vitamin D therapy for 6 weeks, followed by a 12-week washout period, and finally the remaining treatment arm for 6 weeks. Intensive vitamin D treatment includes alfacalcidiol (activated vitamin D) 0.25mcg orally with each dialysis session combined with ergocalciferol (nutritional vitamin D) 50 000 IU orally once per week and placebo the remaining two dialysis days for 6 weeks. The standard vitamin D treatment includes alfacalcidiol 0.25mcg orally combined with placebo each dialysis session per week for 6 weeks. Cardiac autonomic tone is measured via 24 h Holter monitor assessments on the first dialysis day of the week every 6 weeks throughout the study period. The primary outcome is change in the low frequency: high frequency heart rate variability (HRV) ratio during the first 12 h of the Holter recording at 6 weeks versus baseline. Secondary outcomes include additional

  4. Physical Activity, Weight Control, and Breast Cancer Risk and Survival: Clinical Trial Rationale and Design Considerations

    PubMed Central

    Hunsberger, Sally; Alciati, Marianne H.; Blair, Steven N.; Goodwin, Pamela J.; McTiernan, Anne; Wing, Rena; Schatzkin, Arthur

    2009-01-01

    Substantial observational epidemiological evidence exists that physical activity and weight control are associated with decreased risk of postmenopausal breast cancer. Uncertainty remains regarding several aspects of these associations, including the effect of possible confounding factors on these associations. We present the rationale and design for two randomized controlled trials that can help resolve this uncertainty. In a 5-year prevention trial conducted among women at high risk of breast cancer, the primary endpoint would be breast cancer incidence. For a comparable survivorship trial, the primary endpoint would be the disease-free interval and secondary endpoints would be breast cancer recurrence–free interval, second primary breast cancer, and total invasive plus in situ breast cancer. A set of inclusion and exclusion criteria is proposed for both trials. Intervention goals are the same for both trials. Goals for the weight control intervention would be, for women whose body mass index (BMI) is greater than 25 kg/m2, to lose 10% of body weight and, for women whose BMI is less than or equal to 25 kg/m2, to avoid weight gain. The goal for the physical activity intervention would be to achieve and maintain regular participation in a moderate-intensity physical activity program for a total of 150–225 minutes over at least 5 days per week. Sample size calculations are based on alternative assumptions about hazard ratio, adherence, follow-up duration, and power and are presented for the primary prevention and survivorship trials. Although both studies could enhance our understanding of breast cancer etiology and benefit public health, practical considerations, including smaller sample size, ease of recruitment, and reduced likelihood of early termination, favor the survivorship trial at this time. PMID:19401543

  5. The Effects of Fructose Intake on Serum Uric Acid Vary among Controlled Dietary Trials1234

    PubMed Central

    Wang, D. David; Sievenpiper, John L.; de Souza, Russell J.; Chiavaroli, Laura; Ha, Vanessa; Cozma, Adrian I.; Mirrahimi, Arash; Yu, Matthew E.; Carleton, Amanda J.; Di Buono, Marco; Jenkins, Alexandra L.; Leiter, Lawrence A.; Wolever, Thomas M. S.; Beyene, Joseph; Kendall, Cyril W. C.; Jenkins, David J. A.

    2012-01-01

    Hyperuricemia is linked to gout and features of metabolic syndrome. There is concern that dietary fructose may increase uric acid concentrations. To assess the effects of fructose on serum uric acid concentrations in people with and without diabetes, we conducted a systematic review and meta-analysis of controlled feeding trials. We searched MEDLINE, EMBASE, and the Cochrane Library for relevant trials (through August 19, 2011). Analyses included all controlled feeding trials ≥7 d investigating the effect of fructose feeding on uric acid under isocaloric conditions, where fructose was isocalorically exchanged with other carbohydrate, or hypercaloric conditions, and where a control diet was supplemented with excess energy from fructose. Data were aggregated by the generic inverse variance method using random effects models and expressed as mean difference (MD) with 95% CI. Heterogeneity was assessed by the Q statistic and quantified by I2. A total of 21 trials in 425 participants met the eligibility criteria. Isocaloric exchange of fructose for other carbohydrate did not affect serum uric acid in diabetic and nondiabetic participants [MD = 0.56 μmol/L (95% CI: −6.62, 7.74)], with no evidence of inter-study heterogeneity. Hypercaloric supplementation of control diets with fructose (+35% excess energy) at extreme doses (213–219 g/d) significantly increased serum uric acid compared with the control diets alone in nondiabetic participants [MD = 31.0 mmol/L (95% CI: 15.4, 46.5)] with no evidence of heterogeneity. Confounding from excess energy cannot be ruled out in the hypercaloric trials. These analyses do not support a uric acid-increasing effect of isocaloric fructose intake in nondiabetic and diabetic participants. Hypercaloric fructose intake may, however, increase uric acid concentrations. The effect of the interaction of energy and fructose remains unclear. Larger, well-designed trials of fructose feeding at “real world” doses are needed. PMID:22457397

  6. Visual Field Outcomes for the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT)

    PubMed Central

    Wall, Michael; Johnson, Chris A.; Cello, Kimberly E.; Zamba, K. D.; McDermott, Michael P.; Keltner, John L.

    2016-01-01

    Purpose The Idiopathic Intracranial Hypertension Treatment Trial (IIHTT) showed that acetazolamide provided a modest, significant improvement in mean deviation (MD). Here, we further analyze visual field changes over the 6-month study period. Methods Of 165 subjects with mild visual loss in the IIHTT, 125 had perimetry at baseline and 6 months. We evaluated pointwise linear regression of visual sensitivity versus time to classify test locations in the worst MD (study) eye as improving or not; pointwise changes from baseline to month 6 in decibels; and clinical consensus of change from baseline to 6 months. Results The average study eye had 36 of 52 test locations with improving sensitivity over 6 months using pointwise linear regression, but differences between the acetazolamide and placebo groups were not significant. Pointwise results mostly improved in both treatment groups with the magnitude of the mean change within groups greatest and statistically significant around the blind spot and the nasal area, especially in the acetazolamide group. The consensus classification of visual field change from baseline to 6 months in the study eye yielded percentages (acetazolamide, placebo) of 7.2% and 17.5% worse, 35.1% and 31.7% with no change, and 56.1% and 50.8% improved; group differences were not statistically significant. Conclusions In the IIHTT, compared to the placebo group, the acetazolamide group had a significant pointwise improvement in visual field function, particularly in the nasal and pericecal areas; the latter is likely due to reduction in blind spot size related to improvement in papilledema. (ClinicalTrials.gov number, NCT01003639.) PMID:26934136

  7. Regression of Fibroadenomas with Centchroman: a Randomized Controlled Trial.

    PubMed

    Tejwani, Prakash Laxmichand; Nerkar, Hrishikesh; Dhar, Anita; Kataria, Kamal; Hari, Smriti; Thulkar, Sanjay; Chumber, Sunil; Kumar, Sunesh; Srivastava, Anurag

    2015-12-01

    Fibroadenoma is a common cause of breast lump in young girls. Nearly 10-15 % of lesions regress spontaneously over the period of 6 to 60 months. The aim of study was to investigate the role of Centchroman in regression of fibroadenoma in comparison to natural observation and to study the association of hormonal receptors with degree of regression. The study was carried out at the outpatient clinic of Department of Surgery, All India Institute of Medical Sciences, New Delhi, from November 2004 to November 2007. Patients aged ≤30 years with fibroadenoma were included. Patients with fibroadenoma equal to or larger than 5 cm and with polycystic ovarian disease were excluded. Patients were randomized in two groups. Patients in active therapy arm were prescribed Centchroman 30 mg daily for 12 weeks, and another group was observed without any intervention (control group). Patients were followed at weeks 4, 8, 12, and 24 to assess response to therapy. Twenty-two (31.88 %) fibroadenomas in Centchroman arm disappeared completely as compared to four (7.69 %) in control arm over a period of 6 months. There was a decrease in the volume of fibroadenoma in ten (19.23 %) patients in control arm and 36 (52.17 %) patients in Centchroman arm. Centchroman therapy allowed 31 % fibroadenoma to regress completely with scanty menses or amenorrhea as the only side effect. PMID:26730050

  8. Stochastic resonance whole-body vibration improves postural control in health care professionals: a worksite randomized controlled trial.

    PubMed

    Elfering, Achim; Schade, Volker; Stoecklin, Lukas; Baur, Simone; Burger, Christian; Radlinger, Lorenz

    2014-05-01

    Slip, trip, and fall injuries are frequent among health care workers. Stochastic resonance whole-body vibration training was tested to improve postural control. Participants included 124 employees of a Swiss university hospital. The randomized controlled trial included an experimental group given 8 weeks of training and a control group with no intervention. In both groups, postural control was assessed as mediolateral sway on a force plate before and after the 8-week trial. Mediolateral sway was significantly decreased by stochastic resonance whole-body vibration training in the experimental group but not in the control group that received no training (p < .05). Stochastic resonance whole-body vibration training is an option in the primary prevention of balance-related injury at work.

  9. Simulation of plume dispersion of multiple releases in Fusion Field Trial-07 experiment

    NASA Astrophysics Data System (ADS)

    Pandey, Gavendra; Sharan, Maithili

    2015-12-01

    For an efficient source term estimation, it is important to use an accurate dispersion model with appropriate dispersion parameters. This is examined by simulating the dispersion of plumes resulted from the available multiple releases conducted at Fusion Field Trials, Dugway Proving Ground, Utah. The simulation is carried out with an earlier developed IIT (Indian Institute of Technology) dispersion model using the dispersion parameters in terms of measurements of turbulent velocity fluctuations. Simulation is discussed separately in both stable and unstable conditions in light of (i) plume behavior of observed and predicted concentrations in the form of isopleths, (ii) peak/maximum concentrations and (iii) overall concentration distribution. Simulated results from IIT model are compared with those obtained using AERMOD. Both, IIT model and AERMOD, predicted peak concentrations within a factor of two in all the releases and tracer transport is mostly along the mean wind direction. With IIT model, the higher concentrations are predicted close to observations in all the trials of stable conditions and with in a factor of two in the trials of unstable conditions. However, the relatively smaller concentrations are under-predicted severely in stable conditions and over-predicted in unstable conditions. The AERMOD exhibits the similar prediction of concentrations as in IIT model except slightly over-prediction in stable conditions and under-prediction in unstable conditions. The statistical measures for both the models are found good in agreement with the observations and a quantitative analysis based on F-test shows that the performance from both the models are found to be similar at 5% significance level.

  10. Ketorolac for Pain Control With Intrauterine Device Placement: A Randomized Controlled Trial

    PubMed Central

    Ngo, Lynn L.; Ward, Kristy K.; Mody, Sheila K.

    2015-01-01

    Objective To evaluate intramuscular ketorolac compared to placebo saline injection for pain control with intrauterine device (IUD) placement. Methods We conducted a randomized, double-blind, placebo controlled trial between July 2012 and March 2014. Patients received ketorolac 30mg or placebo saline intramuscular injection 30 minutes prior to IUD placement. The primary outcome was pain with IUD placement on a 10cm visual analog scale (VAS). Sample size was calculated to provide 80% power to show a 2.0cm difference (α=0.05) in the primary outcome. Secondary outcomes included pain with study drug injection, speculum insertion, tenaculum placement, uterine sounding, and at 5 and 15 minutes after IUD placement. Results A total of 67 women participated in the study, 33 in the ketorolac arm and 34 in the placebo arm. There were no differences in baseline demographics including age, BMI, and race. There were no differences in median pain scores for IUD placement in the placebo versus ketorolac groups (5.2cm vs 3.6cm, p=0.99). There was a decrease in median pain scores at 5 minutes (2.2cm vs 0.3cm, p=<0.001) and 15 minutes (1.6cm vs 0.1cm, p=<0.001) after IUD placement but no difference for all other time points. Nulliparous participants (n=16, 8 per arm) had a decrease in pain scores with IUD placement (8.1cm vs 5.4cm, p=0.02). In this study, 22% of participants in the placebo group and 18% in the ketorolac group reported injection pain was as painful as IUD placement. Conclusions Ketorolac does not reduce pain with IUD placement but does reduce pain at 5 and 15 minutes after placement. PMID:26241253

  11. Are Randomized Controlled Trials the (G)old Standard? From Clinical Intelligence to Prescriptive Analytics

    PubMed Central

    2016-01-01

    Despite the accelerating pace of scientific discovery, the current clinical research enterprise does not sufficiently address pressing clinical questions. Given the constraints on clinical trials, for a majority of clinical questions, the only relevant data available to aid in decision making are based on observation and experience. Our purpose here is 3-fold. First, we describe the classic context of medical research guided by Poppers’ scientific epistemology of “falsificationism.” Second, we discuss challenges and shortcomings of randomized controlled trials and present the potential of observational studies based on big data. Third, we cover several obstacles related to the use of observational (retrospective) data in clinical studies. We conclude that randomized controlled trials are not at risk for extinction, but innovations in statistics, machine learning, and big data analytics may generate a completely new ecosystem for exploration and validation. PMID:27383622

  12. Are Randomized Controlled Trials the (G)old Standard? From Clinical Intelligence to Prescriptive Analytics.

    PubMed

    Van Poucke, Sven; Thomeer, Michiel; Heath, John; Vukicevic, Milan

    2016-07-06

    Despite the accelerating pace of scientific discovery, the current clinical research enterprise does not sufficiently address pressing clinical questions. Given the constraints on clinical trials, for a majority of clinical questions, the only relevant data available to aid in decision making are based on observation and experience. Our purpose here is 3-fold. First, we describe the classic context of medical research guided by Poppers' scientific epistemology of "falsificationism." Second, we discuss challenges and shortcomings of randomized controlled trials and present the potential of observational studies based on big data. Third, we cover several obstacles related to the use of observational (retrospective) data in clinical studies. We conclude that randomized controlled trials are not at risk for extinction, but innovations in statistics, machine learning, and big data analytics may generate a completely new ecosystem for exploration and validation.

  13. Are Randomized Controlled Trials the (G)old Standard? From Clinical Intelligence to Prescriptive Analytics.

    PubMed

    Van Poucke, Sven; Thomeer, Michiel; Heath, John; Vukicevic, Milan

    2016-01-01

    Despite the accelerating pace of scientific discovery, the current clinical research enterprise does not sufficiently address pressing clinical questions. Given the constraints on clinical trials, for a majority of clinical questions, the only relevant data available to aid in decision making are based on observation and experience. Our purpose here is 3-fold. First, we describe the classic context of medical research guided by Poppers' scientific epistemology of "falsificationism." Second, we discuss challenges and shortcomings of randomized controlled trials and present the potential of observational studies based on big data. Third, we cover several obstacles related to the use of observational (retrospective) data in clinical studies. We conclude that randomized controlled trials are not at risk for extinction, but innovations in statistics, machine learning, and big data analytics may generate a completely new ecosystem for exploration and validation. PMID:27383622

  14. Effects of Berries Consumption on Cardiovascular Risk Factors: A Meta-analysis with Trial Sequential Analysis of Randomized Controlled Trials

    PubMed Central

    Huang, Haohai; Chen, Guangzhao; Liao, Dan; Zhu, Yongkun; Xue, Xiaoyan

    2016-01-01

    The effects of berries consumption on cardiovascular disease (CVD) risk factors have not been systematically examined. Here, we aimed to conduct a meta-analysis with trial sequential analysis to estimate the effect of berries consumption on CVD risk factors. PubMed, Embase, and CENTRAL were searched for randomized controlled trials (RCTs) that regarding the effects of berries consumption in either healthy participants or patients with CVD. Twenty-two eligible RCTs representing 1,251 subjects were enrolled. The pooled result showed that berries consumption significantly lowered the low density lipoprotein (LDL)-cholesterol [weighted mean difference (WMD), −0.21 mmol/L; 95% confidence interval (CI), −0.34 to −0.07; P = 0.003], systolic blood pressure (SBP) (WMD, −2.72 mmHg; 95% CI, −5.32 to −0.12; P = 0.04), fasting glucose (WMD, −0.10 mmol/L; 95% CI, −0.17 to −0.03; P = 0.004), body mass index (BMI) (WMD, −0.36 kg/m2; 95% CI, −0.54 to −0.18, P < 0.00001), Hemoglobin A1c (HbA1c) (WMD, −0.20%; 95% CI, −0.39 to −0.01; P = 0.04) and tumor necrosis factor-α (TNF-α) (WMD, −0.99 ρg/mL; 95% CI, −1.96 to −0.02; P = 0.04). However, no significant changes were seen in other markers. The current evidence suggests that berries consumption might be utilized as a possible new effective and safe supplementary option to better prevent and control CVD in humans. PMID:27006201

  15. A randomised, controlled trial of a dietary intervention for adults with major depression (the “SMILES” trial): study protocol

    PubMed Central

    2013-01-01

    Background Despite increased investment in its recognition and treatment, depression remains a substantial health and economic burden worldwide. Current treatment strategies generally focus on biological and psychological pathways, largely neglecting the role of lifestyle. There is emerging evidence to suggest that diet and nutrition play an important role in the risk, and the genesis, of depression. However, there are limited data regarding the therapeutic impact of dietary changes on existing mental illness. Using a randomised controlled trial design, we aim to investigate the efficacy and cost-efficacy of a dietary program for the treatment of Major Depressive Episodes (MDE). Methods/Design One hundred and seventy six eligible participants suffering from current MDE are being randomised into a dietary intervention group or a social support group. Depression status is assessed using the Montgomery–Åsberg Depression Rating Scale (MADRS) and Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (Non Patient Edition) (SCID-I/NP). The intervention consists of 7 individual nutrition consulting sessions (of approximately 60 minutes), delivered by an Accredited Practising Dietitian (APD). Sessions commence within one week of baseline assessment. The intervention focuses on advocating a healthy diet based on the Australian Dietary Guidelines and the Dietary Guidelines for Adults in Greece. The control condition comprises a befriending protocol using the same visit schedule and length as the diet intervention. The study is being conducted at two locations in Victoria, Australia (a metropolitan and regional centre). Data collection occurs at baseline (pre-intervention), 3-months (post-intervention) and 6– months. The primary endpoint is MADRS scores at 3 months. A cost consequences analysis will determine the economic value of the intervention. Discussion If efficacious, this program could provide an alternative or adjunct treatment

  16. Evolution of the lipid trial protocol of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial.

    PubMed

    Ginsberg, Henry N; Bonds, Denise E; Lovato, Laura C; Crouse, John R; Elam, Marshall B; Linz, Peter E; O'connor, Patrick J; Leiter, Lawrence A; Weiss, Daniel; Lipkin, Edward; Fleg, Jerome L

    2007-06-18

    The Action to Control Cardiovascular Risk in Diabetes (ACCORD) lipid trial aims to test whether a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin) plus a fibrate is more efficacious in reducing cardiovascular events than a statin plus placebo in patients with type 2 diabetes mellitus with defined glycemic control. This is a blinded component in a 5,518-patient subset of the ACCORD cohort. These participants were randomized to either be (1) treated with simvastatin (titrated to 40 mg/day if necessary to achieve a goal low-density lipoprotein [LDL] cholesterol level of <2.59 mmol/L [100 mg/dL]) plus placebo or (2) treated to the same goal LDL cholesterol level with the statin plus active fenofibrate 160 mg/day or its bioequivalent (or 54 mg/day if the estimated glomerular filtration rate ranges from 30 to <50 mL/min per 1.73 m2). Setting an upper limit of LDL cholesterol qualifying for randomization excluded patients who would not likely achieve the LDL cholesterol goal. Recruitment for ACCORD began in January 2001, and follow-up is scheduled to end in June 2009. Since recruitment began, several clinical trials and consensus statements have been published that led to changes in the details of the lipid treatment algorithm and protocol. This report describes the design of the lipid protocol and modifications to the protocol during the course of the study in response to and in anticipation of these developments. The current protocol is designed to provide an ethically justifiable test of combined statin plus fibrate treatment consistent with the highest level of safety and lipid treatment standards of care.

  17. Outpatient versus inpatient opioid detoxification: a randomized controlled trial.

    PubMed

    Day, Ed; Strang, John

    2011-01-01

    Opioid detoxification is not an effective stand-alone treatment for heroin dependence but is nevertheless an essential step in the path to recovery. There has been relatively little previous controlled research on the impact of treatment setting on the likelihood of successful completion of detoxification. In this study, 68 opioid-dependent patients receiving community treatment (predominantly with methadone) and requesting detoxification were randomly assigned to an inpatient versus outpatient setting. Both groups received the same medication (lofexidine), and the primary outcome measure was being opioid-free at detoxification completion. More inpatients (n = 18, 51.4%) than outpatients (n = 12, 36.4%) completed detoxification, but this difference was not statistically significant (χ(2) = 1.56, p = .21). However, the outpatient group received a significantly longer period of medication, and when the length of detoxification was controlled for, the results favored the inpatient setting (Exp(B) = 13.9, 95% confidence interval = 2.6-75.5, p = .002). Only 11 (16%) participants were opioid-free at the 1-month follow-up and 8 at the 6-month follow-up, with no between-group difference. Inpatient and outpatient opioid detoxification settings were not significantly different in completion or follow-up abstinence rates, but aspects of the study design may have favored the outpatient setting. Future studies should test patient characteristics that predict better outcomes in each setting.

  18. CSI, optimal control, and accelerometers: Trials and tribulations

    NASA Technical Reports Server (NTRS)

    Benjamin, Brian J.; Sesak, John R.

    1994-01-01

    New results concerning optimal design with accelerometers are presented. These results show that the designer must be concerned with the stability properties of two Linear Quadratic Gaussian (LQG) compensators, one of which does not explicitly appear in the closed-loop system dynamics. The new concepts of virtual and implemented compensators are introduced to cope with these subtleties. The virtual compensator appears in the closed-loop system dynamics and the implemented compensator appears in control electronics. The stability of one compensator does not guarantee the stability of the other. For strongly stable (robust) systems, both compensators should be stable. The presence of controlled and uncontrolled modes in the system results in two additional forms of the compensator with corresponding terms that are of like form, but opposite sign, making simultaneous stabilization of both the virtual and implemented compensator difficult. A new design algorithm termed sensor augmentation is developed that aids stabilization of these compensator forms by incorporating a static augmentation term associated with the uncontrolled modes in the design process.

  19. A Systematic Review of Randomized Controlled Trials on Oral Chinese Herbal Medicine for Prostate Cancer

    PubMed Central

    Li, Xun; Wang, Yuyi; Chen, Shiuan; Liu, Jian-ping

    2016-01-01

    Background Prostate cancer is the most common malignant tumor associated with male reproductive system. Objective The existing eligible randomized controlled trials (RCTs) were critically appraised for the safety and effectiveness of CHM for prostate cancer. Methods A literature search was conducted by using PubMed, CENTRAL, CNKI, CBM, VIP and Wanfang databases until August 2015. RCTs of CHM or CHM plus conventional medicine for prostate cancer patients were included. The primary outcomes appraised were survival time, time to progression and quality of life. The risk of bias assessment according to the Cochrane Handbook was used to evaluate the methodological quality of the included trials. Revman 5.3 software was used for data analyses. Risk ratio and mean difference (MD) with a 95% confidence interval (CI) were used as effect measures. Meta-analysis was to be used if sufficient trials without obvious clinical or statistical heterogeneity were available. Results A total of 17 RCTs involving 1224 participants were analyzed. One trial was about CHM comparing to no treatment. The remaining 16 trials used CHMs as adjunctive treatment for endocrine therapy. Due to the poor quality of methodologies of most trials, only limited evidence showed that a combination of CHM and endocrine therapy might be more effective in restraining the development of the disease (MD 10.37 months, 95%CI 9.10 to 11.63 months), increasing patients’ survival time (7–15 months) or improving patients’ performance status, when compared to endocrine therapy alone (Karnofsky performance scale average changed 15 scores between groups). No severe adverse event was reported related to CHM. Conclusion Due to the insufficient quality of trials that were analyzed, it is not appropriate to recommend any kind of CHMs in treating prostate cancer at the present time. Well-designed trials with high methodological quality are needed to validate the effect of CHMs for patients with prostate cancer. PMID

  20. An Internet Intervention to Improve Asthma Management: Rationale and Protocol of a Randomized Controlled Trial

    PubMed Central

    Lau, Annie YS; Dennis, Sarah; Liaw, Siaw-Teng; Coiera, Enrico

    2013-01-01

    Background Many studies have shown the effectiveness of self-management for patients with asthma. In particular, possession and use of a written asthma action plan provided by a doctor has shown to significantly improve patients’ asthma control. Yet, uptake of a written asthma action plan and preventative asthma management is low in the community, especially amongst adults. Objective A Web-based personally controlled health management system (PCHMS) called Healthy.me will be evaluated in a 2010 CONSORT-compliant 2-group (static websites verse PCHMS) parallel randomized controlled trial (RCT) (allocation ratio 1:1). Methods The PCHMS integrates an untethered personal health record with consumer care pathways and social forums. After eligibility assessment, a sample of 300 adult patients with moderate persistent asthma will be randomly assigned to one of these arms. After 12 months of using either Healthy.me or information websites (usual care arm), a post-study assessment will be conducted. Results The primary outcome measure is possession of or revision of an asthma action plan during the study. Secondary outcome measures include: (1) adherence to the asthma action plan, (2) rate of planned and unplanned visits to healthcare providers for asthma issues, (3) usage patterns of Healthy.me and attrition rates, (4) asthma control and asthma exacerbation scores, and (5) impact of asthma on life and competing demands, and days lost from work. Conclusions This RCT will provide insights into whether access to an online PCHMS will improve uptake of a written asthma action plan and preventative asthma actions. Trial Registration Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12612000716864; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=362714 (Archived by WebCite at http://www.webcitation.org/6IYBJGRnW). PMID:23942523

  1. Calculating the probability of random sampling for continuous variables in submitted or published randomised controlled trials.

    PubMed

    Carlisle, J B; Dexter, F; Pandit, J J; Shafer, S L; Yentis, S M

    2015-07-01

    In a previous paper, one of the authors (JBC) used a chi-squared method to analyse the means (SD) of baseline variables, such as height or weight, from randomised controlled trials by Fujii et al., concluding that the probabilities that the reported distributions arose by chance were infinitesimally small. Subsequent testing of that chi-squared method, using simulation, suggested that the method was incorrect. This paper corrects the chi-squared method and tests its performance and the performance of Monte Carlo simulations and ANOVA to analyse the probability of random sampling. The corrected chi-squared method and ANOVA method became inaccurate when applied to means that were reported imprecisely. Monte Carlo simulations confirmed that baseline data from 158 randomised controlled trials by Fujii et al. were different to those from 329 trials published by other authors and that the distribution of Fujii et al.'s data were different to the expected distribution, both p < 10(-16) . The number of Fujii randomised controlled trials with unlikely distributions was less with Monte Carlo simulation than with the 2012 chi-squared method: 102 vs 117 trials with p < 0.05; 60 vs 86 for p < 0.01; 30 vs 56 for p < 0.001; and 12 vs 24 for p < 0.00001, respectively. The Monte Carlo analysis nevertheless confirmed the original conclusion that the distribution of the data presented by Fujii et al. was extremely unlikely to have arisen from observed data. The Monte Carlo analysis may be an appropriate screening tool to check for non-random (i.e. unreliable) data in randomised controlled trials submitted to journals.

  2. The next trial will be conflicting! Effects of explicit congruency pre-cues on cognitive control.

    PubMed

    Bugg, Julie M; Smallwood, Alicia

    2016-01-01

    The dual mechanisms of control account proposed a role for proactive and reactive mechanisms in minimizing or resolving interference in conflict tasks. Proactive mechanisms are activated in advance of stimulus onset and lead to preparatory biasing of attention in a goal-directed fashion. Reactive mechanisms are triggered post-stimulus onset. Using an explicit, trial-by-trial pre-cueing procedure in a 4-choice color-word Stroop task, we investigated effects of congruency pre-cues on cognitive control. Under conditions of stimulus uncertainty (i.e., each word was associated with multiple, equally probable responses), pre-cue benefits were observed on incongruent trials when cues were 100% valid but not when they were 75% valid. These benefits were selectively found at the longest cue-to-stimulus interval (2,000 ms), consistent with a preparation-dependent proactive control mechanism. By contrast, when a reactive strategy of switching attention to the irrelevant dimension to predict the single correlated response was viable, pre-cue benefits were observed on incongruent trials for all cue-to-stimulus intervals including the shortest that afforded only 500 ms to prepare. The findings (a) suggest a restricted role for the preparation-dependent biasing of attention via proactive control in response to explicit, trial-by-trial pre-cues while (b) highlighting strategies that lead to pre-cue benefits but which appear to reflect primarily reactive use of the information afforded by the pre-cues. We conclude that pre-cues, though available in advance of stimulus onset, may stimulate proactive or reactive minimization of interference. PMID:25522873

  3. Biases in Estimating Treatment Effects Due to Attrition in Randomized Controlled Trials and Cluster Randomized Controlled Trials: A Simulation Study

    ERIC Educational Resources Information Center

    Dong, Nianbo; Lipsey, Mark W.

    2011-01-01

    Attrition occurs when study participants who were assigned to the treatment and control conditions do not provide outcome data and thus do not contribute to the estimation of the treatment effects. It is very common in experimental studies in education as illustrated, for instance, in a meta-analysis studying "the effects of attrition on baseline…

  4. Randomized controlled trials and meta-analysis in medical education: what role do they play?

    PubMed

    Cook, David A

    2012-01-01

    Education researchers seek to understand what works, for whom, in what circumstances. Unfortunately, educational environments are complex and research itself is highly context dependent. Faced with these challenges, some have argued that qualitative methods should supplant quantitative methods such as randomized controlled trials (RCTs) and meta-analysis. I disagree. Good qualitative and mixed-methods research are complementary to, rather than exclusive of, quantitative methods. The complexity and challenges we face should not beguile us into ignoring methods that provide strong evidence. What, then, is the proper role for RCTs and meta-analysis in medical education? First, the choice of study design depends on the research question. RCTs and meta-analysis are appropriate for many, but not all, study goals. They have compelling strengths but also numerous limitations. Second, strong methods will not compensate for a pointless question. RCTs do not advance the science when they make confounded comparisons, or make comparison with no intervention. Third, clinical medicine now faces many of the same challenges we encounter in education. We can learn much from other fields about how to handle complexity in RCTs. Finally, no single study will definitively answer any research question. We need carefully planned, theory-building, programmatic research, reflecting a variety of paradigms and approaches, as we accumulate evidence to change the art and science of education.

  5. Randomized controlled trials of maternal-fetal surgery: a challenge to clinical equipoise.

    PubMed

    Rodrigues, H C M L; van den Berg, P P

    2014-10-01

    This article focuses on maternal-fetal surgery (MFS) and on the concept of clinical equipoise that is a widely accepted requirement for conducting randomized controlled trials (RCT). There are at least three reasons why equipoise is unsuitable for MFS. First, the concept is based on a misconception about the nature of clinical research and the status of research subjects. Second, given that it is not clear who the research subject/s in MFS is/are, if clinical equipoise is to be used as a criterion to test the ethical appropriateness of RCT, its meaning should be unambiguous. Third, because of the multidisciplinary character of MFS, it is not clear who should be in equipoise. As a result, we lack an adequate criterion for the ethical review of MFS protocols. In our account, which is based on Chervenak and McCullough's seminal work in the field of obstetric ethics, equipoise is abandoned. and RCT involving MFS can be ethically initiated when a multidisciplinary ethics review board (ERB), having an evidence-based assessment of the risks involved, is convinced that the value of answering the research hypothesis, for the sake of the health interests of future pregnant women carrying fetuses with certain congenital birth defects, justifies the actual risks research participants might suffer within a set limit of low/manageable.

  6. Recruiting older people to a randomised controlled dietary intervention trial - how hard can it be?

    PubMed Central

    2010-01-01

    Background The success of a human intervention trial depends upon the ability to recruit eligible volunteers. Many trials fail because of unrealistic recruitment targets and flawed recruitment strategies. In order to predict recruitment rates accurately, researchers need information on the relative success of various recruitment strategies. Few published trials include such information and the number of participants screened or approached is not always cited. Methods This paper will describe in detail the recruitment strategies employed to identify older adults for recruitment to a 6-month randomised controlled dietary intervention trial which aimed to explore the relationship between diet and immune function (The FIT study). The number of people approached and recruited, and the reasons for exclusion, will be discussed. Results Two hundred and seventeen participants were recruited to the trial. A total of 7,482 letters were sent to potential recruits using names and addresses that had been supplied by local Family (General) Practices. Eight hundred and forty three potential recruits replied to all methods of recruitment (528 from GP letters and 315 from other methods). The eligibility of those who replied was determined using a screening telephone interview, 217 of whom were found to be suitable and agreed to take part in the study. Conclusion The study demonstrates the application of multiple recruitment methods to successfully recruit older people to a randomised controlled trial. The most successful recruitment method was by contacting potential recruits by letter on NHS headed note paper using contacts provided from General Practices. Ninety percent of recruitment was achieved using this method. Adequate recruitment is fundamental to the success of a research project, and appropriate strategies must therefore be adopted in order to identify eligible individuals and achieve recruitment targets. Trial registration number ISRCTN45031464. PMID:20175903

  7. Acupuncture for acute stroke: study protocol for a multicenter, randomized, controlled trial

    PubMed Central

    2014-01-01

    Background Acupuncture has been widely used as a treatment for stroke in China for more than 3,000 years. However, previous research has not yet shown that acupuncture is effective as a stroke treatment. We report a protocol for a multicenter, randomized, controlled, and outcome assessor-blind trial to evaluate the efficacy and safety of acupuncture on acute ischemic stroke. Methods/Design In a prospective trial involving three hospitals in the Zhejiang Province (China) 250 patients with a recent (less than 1 week previous) episode of ischemic stroke will be included. Patients will be randomized into two groups: an acupuncture group given scalp acupuncture and electroacupuncture, and a control group given no acupuncture. Eighteen treatment sessions will be performed over a three-week period. The primary outcome will be measured by changes in the National Institutes of Health Stroke Scale score at the one, three, and four-week follow-up. Secondary outcome measures will be: 1) the Fugl-Meyer assessment scale for motor function; 2) the mini-mental state examination and Montreal cognitive assessment for cognitive function; 3) the video-fluoroscopic swallowing study for swallowing ability; and 4) the incidence of adverse events. Discussion This trial is expected to clarify whether or not acupuncture is effective for acute stroke. It will also show if acupuncture can improve motor, cognitive, or swallowing function. Trial registration Chinese Clinical Trial Registry ChiCTR-TRC-12001971. PMID:24908241

  8. Laparoscopic versus open adhesiolysis for small bowel obstruction - a multicenter, prospective, randomized, controlled trial

    PubMed Central

    2014-01-01

    Background Laparoscopic adhesiolysis is emerging as an alternative for open surgery in adhesive small bowel obstruction. Retrospective studies suggest that laparoscopic approach shortens hospital stay and reduces complications in these patients. However, no prospective, randomized, controlled trials comparing laparoscopy to open surgery have been published. Methods/Design This is a multicenter, prospective, open label, randomized, controlled trial comparing laparoscopic adhesiolysis to open surgery in patients with computed-tomography diagnosed adhesive small bowel obstruction that is not resolving with conservative management. The primary study endpoint is the length of postoperative hospital stay in days. Sample size was estimated based on preliminary retrospective cohort, which suggested that 102 patients would provide 80% power to detect a difference of 2.5 days in the length of postoperative hospital stay with significance level of 0.05. Secondary endpoints include passage of stool, commencement of enteral nutrition, 30-day mortality, complications, postoperative pain, and the length of sick leave. Tertiary endpoints consist of the rate of ventral hernia and the recurrence of small bowel obstruction during long-term follow-up. Long-term follow-up by letter or telephone interview will take place at 1, 5, and 10 years. Discussion To the best of our knowledge, this trial is the first one aiming to provide level Ib evidence to assess the use of laparoscopy in the treatment of adhesive small bowel obstruction. Trial registration ClinicalTrials.gov identifier: NCT01867528. Date of registration May 26th 2013. PMID:25306234

  9. Acupuncture for treating polycystic ovary syndrome: guidance for future randomized controlled trials*

    PubMed Central

    Wu, Yan; Robinson, Nicola; Hardiman, Paul J.; Taw, Malcolm B.; Zhou, Jue; Wang, Fang-fang; Qu, Fan

    2016-01-01

    Objective: To provide guidance for future randomized controlled trials (RCTs) based on a review concerning acupuncture for treating polycystic ovary syndrome (PCOS). Methods: A comprehensive literature search was conducted in October 2015 using MEDLINE, EMBASE, SCISEARCH, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Menstrual Disorders and Subfertility Group trials register, Allied and Complementary Medicine (AMED), China National Knowledge Infrastructure (CNKI), and the Wanfang databases. RCTs comparing either acupuncture with no/sham/pharmacological intervention or a combination of acupuncture and conventional therapy with conventional therapy in the treatment of PCOS were included in this review. A quality evaluation was performed for each of the included studies. Results: Thirty-one RCTs were included in the review and were divided into four categories according to the type of intervention used in the comparator or control group. Menstrual frequency, hormones, anthropometrics, insulin sensitivity, blood lipids, and fertility were used as the main measurements to assess the effects of acupuncture on the patients with PCOS. Thirty trials, except for one, showed an improvement in at least one of the indicators of PCOS after acupuncture treatment. However, normalizing the methodological and reporting format remains an issue. Conclusions: Based upon this review of current clinical trials concerning acupuncture for treating PCOS, we provide guidelines for better clinical trial design in the future. PMID:26984837

  10. Cable development for distributed geophysical sensing with a field trial in surface seismic

    NASA Astrophysics Data System (ADS)

    Lumens, Paul; Franzen, Andre; Hornman, Kees; Grandi Karam, Samantha; Hemink, Gijs; Kuvshinov, Boris; La Follett, Jon; Wyker, Brendan; Zwartjes, Paul

    2013-05-01

    Fibre-optic distributed sensing has the potential to revolutionize well and reservoir surveillance in the oil and gas industry. Benefits include the passive nature of optical fibre sensors, the potential for cost-effective installations, combined with the possibility of densely distributed measurements along the entire length of the fibre. Amongst a range of fibre-optic sensing technologies, Distributed Acoustic Sensing has the potential to provide a low cost alternative for conventional seismic technologies. To widen the geophysical application scope further, the fibre-optic sensing cable should be made more sensitive to incoming seismic waves that arrive at the cable perpendicular ("broadside") to its axial direction. We introduce the development of such cable concepts, and present results of a successful cable deployment in a surface seismic field trial. Efforts continue to realize cost-effective directionally-sensitive cables for geophysical use, for deployment down-hole and on surface.

  11. Field trials of the Baby Check score card: mothers scoring their babies at home.

    PubMed

    Thornton, A J; Morley, C J; Green, S J; Cole, T J; Walker, K A; Bonnett, J M

    1991-01-01

    The Baby Check score card has been developed to help parents and health professionals grade the severity of acute illness in babies. This paper reports the results of two field trials in which mothers used Baby Check at home, 104 mothers scoring their babies daily for a week and 56 using it for six months. They all found Baby Check easy to use, between 68% and 81% found it useful, and 96% would recommended it to others. Over 70% of those using it daily used it very competently. Those using it infrequently did less well, suggesting that familiarity with the assessment is important. The scores obtained show that Baby Check's use would not increase the number of mothers seeking medical advice. With introduction and practice most mothers should be able to use Baby Check effectively. It should help them assess their babies' illnesses and make appropriate decisions about seeking medical advice.

  12. IAEA workshop and field trial at the Oak Ridge K-25 Site

    SciTech Connect

    Hembree, D.M. Jr.; Ross, H.H.; Carter, J.A.

    1995-03-01

    In March 1994, members of the International Safeguards Department in the National Security Program Office (NSPO) hosted an environmental monitoring field trial workshop for International Atomic Energy Agency (IAEA) inspectors. The workshop was held at the Oak Ridge K-25 Site and its primary purpose was to train the inspectors in the techniques needed for effective environmental sample collection and handling. The workshop emphasized both sampling theory and practice. First, detailed techniques for swipe, vegetation, soil, biota, and water-associated sampling were covered in the classroom. Subsequently, the inspectors were divided into three groups for actual sample collection in and around the K-25 locale. The collected samples were processed by the Department of Energy (DOE) Network of Analytical Laboratories using established analytical techniques. This activity is part of the IAEA ``Programme 93+2 in. assessment of measures to enhance IAEA safeguards.

  13. Auxiliary-field based trial wave functions in quantum Monte Carlo simulations

    NASA Astrophysics Data System (ADS)

    Chang, Chia-Chen; Rubenstein, Brenda; Morales, Miguel

    We propose a simple scheme for generating correlated multi-determinant trial wave functions for quantum Monte Carlo algorithms. The method is based on the Hubbard-Stratonovich transformation which decouples a two-body Jastrow-type correlator into one-body projectors coupled to auxiliary fields. We apply the technique to generate stochastic representations of the Gutzwiller wave function, and present benchmark resuts for the ground state energy of the Hubbard model in one dimension. Extensions of the proposed scheme to chemical systems will also be discussed. This work was performed under the auspices of the U.S. Department of Energy by Lawrence Livermore National Laboratory under Contract DE-AC52-07NA27344, 15-ERD-013.

  14. Children's mental health care following Hurricane Katrina: a field trial of trauma-focused psychotherapies.

    PubMed

    Jaycox, Lisa H; Cohen, Judith A; Mannarino, Anthony P; Walker, Douglas W; Langley, Audra K; Gegenheimer, Kate L; Scott, Molly; Schonlau, Matthias

    2010-04-01

    New Orleans school children participated in an assessment and field trial of two interventions 15 months after Hurricane Katrina. Children (N = 195) reported on hurricane exposure, lifetime trauma exposure, peer and parent support, posttraumatic stress disorder (PTSD), and depressive symptoms. Teachers reported on behavior. At baseline, 60.5% screened positive for PTSD symptoms and were offered a group intervention at school or individual treatment at a mental health clinic. Uptake of the mental health care was uneven across intervention groups, with 98% beginning the school intervention, compared to 37% beginning at the clinic. Both treatments led to significant symptom reduction of PTSD symptoms, but many still had elevated PTSD symptoms at posttreatment. Implications for future postdisaster mental health work are discussed.

  15. Targeting Children's Behavior Problems in Preschool Classrooms: A Cluster-Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Raver, C. Cybele; Jones, Stephanie M.; Li-Grining, Christine; Zhai, Fuhua; Metzger, Molly W.; Solomon, Bonnie

    2009-01-01

    The present study evaluated the efficacy of a multicomponent, classroom-based intervention in reducing preschoolers' behavior problems. The Chicago School Readiness Project model was implemented in 35 Head Start classrooms using a clustered-randomized controlled trial design. Results indicate significant treatment effects (ds = 0.53-0.89) for…

  16. A Controlled Clinical Trial for Stuttering in Persons Aged 9 to 14 Years.

    ERIC Educational Resources Information Center

    Craig, Ashley; And Others

    1996-01-01

    This paper presents results of a controlled trial of 3 child stuttering treatment strategies in 97 subjects. All 3 treatments (electromyography feedback, intensive smooth speech, and home-based smooth speech) were very successful in the long term for 70% of the group, with electromyography and home-based treatment appearing to be especially…

  17. Randomized Controlled Trial of Video Self-Modeling Following Speech Restructuring Treatment for Stuttering

    ERIC Educational Resources Information Center

    Cream, Angela; O'Brian, Sue; Jones, Mark; Block, Susan; Harrison, Elisabeth; Lincoln, Michelle; Hewat, Sally; Packman, Ann; Menzies, Ross; Onslow, Mark

    2010-01-01

    Purpose: In this study, the authors investigated the efficacy of video self-modeling (VSM) following speech restructuring treatment to improve the maintenance of treatment effects. Method: The design was an open-plan, parallel-group, randomized controlled trial. Participants were 89 adults and adolescents who undertook intensive speech…

  18. Fit 5 Kids TV reduction program for Latino preschoolers: A cluster randomized controlled trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Reducing Latino preschoolers' TV viewing is needed to reduce their risk of obesity and other chronic diseases. This study's objective was to evaluate the Fit 5 Kids (F5K) TV reduction program's impact on Latino preschooler's TV viewing. The study design was a cluster randomized controlled trial (RCT...

  19. A Controlled Trial of the Making Choices Program: Six-Month Follow-up

    ERIC Educational Resources Information Center

    Fraser, Mark W.; Lee, Jung-Sook; Kupper, Lawrence L.; Day, Steven H.

    2011-01-01

    Objective: Six-month follow-up outcomes from a controlled trial of a program designed to prevent aggressive behavior in childhood are described. Method: Data were collected from three sequential cohorts of third graders in two public elementary schools (N = 443). The Year 1 cohort received a routine health curriculum. The Year 2 cohort received…

  20. Testing a Violence-Prevention Intervention for Incarcerated Women Using a Randomized Control Trial

    ERIC Educational Resources Information Center

    Kubiak, Sheryl Pimlott; Kim, Woo Jong; Fedock, Gina; Bybee, Deborah

    2015-01-01

    Objective: Beyond Violence (BV), a new prevention program for women with assaultive offenses, demonstrated feasibility in previous studies. This study's purpose is to assess the efficacy of BV using a randomized control trial. Method: Eligible women were randomly assigned to treatment as usual (TAU) and the experimental condition (BV). Measures of…

  1. Mainstreaming Remedial Mathematics Students in Introductory Statistics: Results Using a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Logue, Alexandra W.; Watanabe-Rose, Mari

    2014-01-01

    This study used a randomized controlled trial to determine whether students, assessed by their community colleges as needing an elementary algebra (remedial) mathematics course, could instead succeed at least as well in a college-level, credit-bearing introductory statistics course with extra support (a weekly workshop). Researchers randomly…

  2. Management of Hypertension in Private Practice: A Randomized Controlled Trial in Continuing Medical Education.

    ERIC Educational Resources Information Center

    Gullion, David S.; And Others

    1988-01-01

    A randomized control trial was used to evaluate a physician education program designed to improve physician management of patients' hypertension, hypertension-related behaviors, and diastolic blood pressure. It was suggested that more intensive continuing medical education programs are needed to improve physician performance and patient outcome.…

  3. Nasal Oxytocin for Social Deficits in Childhood Autism: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Dadds, Mark R.; MacDonald, Elayne; Cauchi, Avril; Williams, Katrina; Levy, Florence; Brennan, John

    2014-01-01

    The last two decades have witnessed a surge in research investigating the application of oxytocin as a method of enhancing social behaviour in humans. Preliminary evidence suggests oxytocin may have potential as an intervention for autism. We evaluated a 5-day "live-in" intervention using a double-blind randomized control trial. 38 male…

  4. Escitalopram in the Treatment of Adolescent Depression: A Randomized Placebo-Controlled Multisite Trial

    ERIC Educational Resources Information Center

    Emslie, Graham J.; Ventura, Daniel; Korotzer, Andrew; Tourkodimitris, Stavros

    2009-01-01

    A randomized, double-blind, placebo-controlled trial that involves 312 male and female patients aged 12-17 reveal the effectiveness of escitalopram in the treatment of depressed adolescents. Eighty-three percent of the participants or 259 participants completed the 8 weeks therapy period.

  5. Training Anxious Children to Disengage Attention from Threat: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Bar-Haim, Yair; Morag, Inbar; Glickman, Shlomit

    2011-01-01

    Background: Threat-related attention biases have been implicated in the etiology and maintenance of anxiety disorders. As a result, attention bias modification (ABM) protocols have been employed as treatments for anxious adults. However, they have yet to emerge for children. A randomized, double-blind placebo-controlled trial was conducted to…

  6. Digestive Enzyme Supplementation for Autism Spectrum Disorders: A Double-Blind Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Munasinghe, Sujeeva A.; Oliff, Carolyn; Finn, Judith; Wray, John A.

    2010-01-01

    To examine the effects of a digestive enzyme supplement in improving expressive language, behaviour and other symptoms in children with Autism Spectrum Disorder. Randomized, double-blind placebo-controlled trial using crossover design over 6 months for 43 children, aged 3-8 years. Outcome measurement tools included monthly Global Behaviour Rating…

  7. Aquatic Physical Therapy for Children with Developmental Coordination Disorder: A Pilot Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Hillier, Susan; McIntyre, Auburn; Plummer, Leanne

    2010-01-01

    Aquatic therapy is an intervention for children with Developmental Coordination Disorder (DCD) that has not been investigated formally. This was a pilot randomized controlled trial to investigate the feasibility and preliminary effectiveness of an aquatic therapy program to improve motor skills of children with DCD. Thirteen children (mean age 7…

  8. Randomized Controlled Trial of a Preventive Intervention for Perinatal Depression in High-Risk Latinas

    ERIC Educational Resources Information Center

    Le, Huynh-Nhu; Perry, Deborah F.; Stuart, Elizabeth A.

    2011-01-01

    Objective: A randomized controlled trial was conducted to evaluate the efficacy of a cognitive-behavioral (CBT) intervention to prevent perinatal depression in high-risk Latinas. Method: A sample of 217 participants, predominantly low-income Central American immigrants who met demographic and depression risk criteria, were randomized into usual…

  9. A Pilot Controlled Trial of Topiramate for Mania in Children and Adolescents with Bipolar Disorder.

    ERIC Educational Resources Information Center

    DelBello, Melissa P.; Findling, Robert L.; Kushner, Stuart; Wang, Daniel; Olson, William H.; Capece, Julie A.; Fazzio, Lydia; Rosenthal, Norman R.

    2005-01-01

    Objective: To assess the efficacy of topiramate monotherapy for acute mania in children and adolescents with bipolar disorder type 1. Method: This double-blind, placebo-controlled study was discontinued early when adult mania trials with topiramate failed to show efficacy. Efficacy end points included the Young Mania Rating Scale (YMRS), Brief…

  10. Factors Influencing Hand Washing Behaviour in Primary Schools: Process Evaluation within a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Chittleborough, Catherine R.; Nicholson, Alexandra L.; Basker, Elaine; Bell, Sarah; Campbell, Rona

    2012-01-01

    This article explores factors that may influence hand washing behaviour among pupils and staff in primary schools. A qualitative process evaluation within a cluster randomized controlled trial included pupil focus groups (n = 16, aged 6-11 years), semi-structured interviews (n = 16 teachers) and observations of hand washing facilities (n = 57).…

  11. Mixed Results from Six Large Randomized Controlled Trials of Learning Communities in Community Colleges

    ERIC Educational Resources Information Center

    Mayer, Alexander K.; Weiss, Michael J.; Visher, Mary G.; Sommo, Colleen; Rudd, Timothy; Cullinan, Dan; Weissman, Evan; Wathington, Heather D.

    2013-01-01

    This paper presents research that explores similarities and differences across six randomized controlled trials of learning communities in community colleges that were conducted by MDRC and the National Center for Postsecondary Research. Five of these studies track students' progress in the program semester and two follow-up semesters, and one…

  12. Randomized Controlled Non-Inferiority Trial of a Telehealth Treatment for Chronic Stuttering: The Camperdown Program

    ERIC Educational Resources Information Center

    Carey, Brenda; O'Brian, Sue; Onslow, Mark; Block, Susan; Jones, Mark; Packman, Ann

    2010-01-01

    Background: Although there are treatments that can alleviate stuttering in adults for clinically significant periods, in Australia there are barriers to the accessibility and availability of best-practice treatment. Aims: This parallel group, non-inferiority randomized controlled trial with multiple blinded outcome assessments investigated whether…

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

    ERIC Educational Resources Information Center

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

    2015-01-01

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

  14. Reading and Language Intervention for Children at Risk of Dyslexia: A Randomised Controlled Trial

    ERIC Educational Resources Information Center

    Duff, Fiona J.; Hulme, Charles; Grainger, Katy; Hardwick, Samantha J.; Miles, Jeremy N. V.; Snowling, Margaret J.

    2014-01-01

    Background: Intervention studies for children at risk of dyslexia have typically been delivered preschool, and show short-term effects on letter knowledge and phoneme awareness, with little transfer to literacy. Methods: This randomised controlled trial evaluated the effectiveness of a reading and language intervention for 6-year-old children…

  15. Randomized Controlled Trial of the Focus Parent Training for Toddlers with Autism: 1-Year Outcome

    ERIC Educational Resources Information Center

    Oosterling, Iris; Visser, Janne; Swinkels, Sophie; Rommelse, Nanda; Donders, Rogier; Woudenberg, Tim; Roos, Sascha; van der Gaag, Rutger Jan; Buitelaar, Jan

    2010-01-01

    This randomized controlled trial compared results obtained after 12 months of nonintensive parent training plus care-as-usual and care-as-usual alone. The training focused on stimulating joint attention and language skills and was based on the intervention described by Drew et al. (Eur Child Adolesc Psychiatr 11:266-272, 2002). Seventy-five…

  16. Educational Benefits of Using Game Consoles in a Primary Classroom: A Randomised Controlled Trial

    ERIC Educational Resources Information Center

    Miller, David J.; Robertson, Derek P.

    2011-01-01

    It is known that computer games are motivating for children, but there is limited direct evidence of their effects on classroom learning. The studies that are available tend to be limited in terms of output data reported, or small in scale, or both. The aim of this randomised controlled trial was to upscale a recent study by Miller and Robertson…

  17. Evaluating the Collaborative Strategic Reading Intervention: An Overview of Randomized Controlled Trial Options

    ERIC Educational Resources Information Center

    Hitchcock, John H.; Kurki, Anja; Wilkins, Chuck; Dimino, Joseph; Gersten, Russell

    2009-01-01

    When attempting to determine if an intervention has a causal impact, the "gold standard" of program evaluation is the randomized controlled trial (RCT). In education studies random assignment is rarely feasible at the student level, making RCTs harder to conduct. School-level assignment is more common but this often requires considerable resources…

  18. A Randomized Controlled Trial Study of the ABRACADABRA Reading Intervention Program in Grade 1

    ERIC Educational Resources Information Center

    Savage, Robert S.; Abrami, Philip; Hipps, Geoffrey; Deault, Louise

    2009-01-01

    This study reports a randomized controlled trial evaluation of a computer-based balanced literacy intervention, ABRACADABRA (http://grover.concordia.ca/abra/version1/abracadabra.html). Children (N = 144) in Grade 1 were exposed either to computer activities for word analysis, text comprehension, and fluency, alongside shared stories (experimental…

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

    ERIC Educational Resources Information Center

    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…

  20. Effect of Art Production on Negative Mood: A Randomized, Controlled Trial

    ERIC Educational Resources Information Center

    Bell, Chloe E.; Robbins, Steven J.

    2007-01-01

    Art therapists have long held that art production causes reductions in stress and elevations in mood (Rubin, 1999). The authors examined this claim in a randomized, controlled trial. Fifty adults between the ages of 18 and 30 were randomly assigned to either create an art work or to view and sort a series of art prints. Three measures of overall…

  1. Multisite Randomized Controlled Trial Examining Intelligent Tutoring of Structure Strategy for Fifth-Grade Readers

    ERIC Educational Resources Information Center

    Wijekumar, Kausalai; Meyer, Bonnie J. F.; Lei, Pui-Wa; Lin, Yu-Chu; Johnson, Lori A.; Spielvogel, James A.; Shurmatz, Kathryn M.; Ray, Melissa; Cook, Michael

    2014-01-01

    This article reports on a large scale randomized controlled trial to study the efficacy of a web-based intelligent tutoring system for the structure strategy designed to improve content area reading comprehension. The research was conducted with 128 fifth-grade classrooms within 12 school districts in rural and suburban settings. Classrooms within…

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

    ERIC Educational Resources Information Center

    Arnott, Simone; Onslow, Mark; O'Brian, Sue; Packman, Ann; Jones, Mark; Block, Susan

    2014-01-01

    Purpose: This study adds to the Lidcombe Program evidence base by comparing individual and group treatment of preschoolers who stutter. Method: A randomized controlled trial of 54 preschoolers was designed to establish whether group delivery outcomes were not inferior to the individual model. The group arm used a rolling group model, in which a…

  3. Improving the General Language Skills of Second-Language Learners in Kindergarten: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Rogde, Kristin; Melby-Lervåg, Monica; Lervåg, Arne

    2016-01-01

    Second-language learners display poorer general language skills in the language used at school than their monolingual peers, which is a concern because general language skills (vocabulary, grammar, language expression, and comprehension) provide the foundation for later academic success. In a randomized controlled trial, we examined the efficacy…

  4. A Randomized Controlled Trial of a Standardized Behavior Management Intervention for Students with Externalizing Behavior

    ERIC Educational Resources Information Center

    Forster, Martin; Sundell, Knut; Morris, Richard J.; Karlberg, Martin; Melin, Lennart

    2012-01-01

    This study reports the results from a Swedish randomized controlled trial of a standardized behavior management intervention. The intervention targeted students with externalizing behavior in a regular education setting. First- and second-grade students (N = 100) from 38 schools were randomly assigned to either the intervention or an active…

  5. Interpretation Training in Individuals with Generalized Social Anxiety Disorder: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Amir, Nader; Taylor, Charles T.

    2012-01-01

    Objective: To examine the efficacy of a multisession computerized interpretation modification program (IMP) in the treatment of generalized social anxiety disorder (GSAD). Method: The sample comprised 49 individuals meeting diagnostic criteria for GSAD who were enrolled in a randomized, double-blind placebo-controlled trial comparing IMP (n = 23)…

  6. Maternal Dietary Counseling Reduces Consumption of Energy-Dense Foods among Infants: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Vitolo, Marcia Regina; Bortolini, Gisele Ane; Campagnolo, Paula Dal Bo; Hoffman, Daniel J.

    2012-01-01

    Objective: To evaluate the impact of a dietary counseling in reducing the intake of energy-dense foods by infants. Design: A randomized controlled trial. Setting and Participants: Sao Leopoldo, Brazil. Mothers and infants of a low-income-group population were randomized into intervention (n = 163) and received dietary counseling during 10 home…

  7. The Efficiency and Efficacy of Equivalence-Based Learning: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Zinn, Tracy E.; Newland, M. Christopher; Ritchie, Katie E.

    2015-01-01

    Because it employs an emergent-learning framework, equivalence-based instruction (EBI) is said to be highly efficient, but its presumed benefits must be compared quantitatively with alternative techniques. In a randomized controlled trial, 61 college students attempted to learn 32 pairs of proprietary and generic drug names using computer-based…

  8. Attachment-Based Family Therapy for Adolescents with Suicidal Ideation: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Diamond, Guy S.; Wintersteen, Matthew B.; Brown, Gregory K.; Diamond, Gary M.; Gallop, Robert; Shelef, Karni; Levy, Suzanne

    2010-01-01

    Objective: To evaluate whether Attachment-Based Family Therapy (ABFT) is more effective than Enhanced Usual Care (EUC) for reducing suicidal ideation and depressive symptoms in adolescents. Method: This was a randomized controlled trial of suicidal adolescents between the ages of 12 and 17, identified in primary care and emergency departments. Of…

  9. What to Do when Data Are Missing in Group Randomized Controlled Trials. NCEE 2009-0049

    ERIC Educational Resources Information Center

    Puma, Michael J.; Olsen, Robert B.; Bell, Stephen H.; Price, Cristofer

    2009-01-01

    This NCEE Technical Methods report examines how to address the problem of missing data in the analysis of data in Randomized Controlled Trials (RCTs) of educational interventions, with a particular focus on the common educational situation in which groups of students such as entire classrooms or schools are randomized. Missing outcome data are a…

  10. Cycling Versus Continuous Mode In Neuromodulator Programming: A Crossover, Randomized, Controlled Trial.

    PubMed

    Beer, Gwendolyn M; Gurule, Margaret M; Komesu, Yuko M; Qualls, Clifford R; Rogers, Rebecca G

    2016-01-01

    This is a randomized, controlled, blind, crossover trial comparing cycling versus continuous programming of a sacral neuromodulator in women diagnosed with overactive bladder (OAB). At 6 months, treatment order significantly affected Overactive Bladder Questionnaire - Short Form (OABq-SF) symptom scores. The cycling followed by continuous stimulation group had superior OABq-SF scores (p > 0.02). PMID:27501593

  11. A Pilot Randomized Controlled Trial of Omega-3 Fatty Acids for Autism Spectrum Disorder

    ERIC Educational Resources Information Center

    Bent, Stephen; Bertoglio, Kiah; Ashwood, Paul; Bostrom, Alan; Hendren, Robert L.

    2011-01-01

    We conducted a pilot randomized controlled trial to determine the feasibility and initial safety and efficacy of omega-3 fatty acids (1.3 g/day) for the treatment of hyperactivity in 27 children ages 3-8 with autism spectrum disorder (ASD). After 12 weeks, hyperactivity, as measured by the Aberrant Behavior Checklist, improved 2.7 (plus or minus…

  12. The Empirical Status of Empirically Supported Psychotherapies: Assumptions, Findings, and Reporting in Controlled Clinical Trials

    ERIC Educational Resources Information Center

    Westen, Drew; Novotny, Catherine M.; Thompson-Brenner, Heather

    2004-01-01

    This article provides a critical review of the assumptions and findings of studies used to establish psychotherapies as empirically supported. The attempt to identify empirically supported therapies (ESTs) imposes particular assumptions on the use of randomized controlled trial (RCT) methodology that appear to be valid for some disorders and…

  13. Using Small-Scale Randomized Controlled Trials to Evaluate the Efficacy of New Curricular Materials

    ERIC Educational Resources Information Center

    Drits-Esser, Dina; Bass, Kristin M.; Stark, Louisa A.

    2014-01-01

    How can researchers in K-12 contexts stay true to the principles of rigorous evaluation designs within the constraints of classroom settings and limited funding? This paper explores this question by presenting a small-scale randomized controlled trial (RCT) designed to test the efficacy of curricular supplemental materials on epigenetics. The…

  14. Review of Randomised Controlled Trials of Internet Interventions for Mental Disorders and Related Conditions

    ERIC Educational Resources Information Center

    Griffiths, Kathleen M.; Christensen, Helen

    2006-01-01

    Self-help Internet interventions have the potential to enable consumers to play a central role in managing their own health. This paper contains a systematic review of 15 randomised controlled trials of the effectiveness of self-help Internet interventions for mental disorders and related conditions. Conditions addressed by the interventions…

  15. Benefits and Harms of Sick Leave: Lack of Randomized, Controlled Trials

    ERIC Educational Resources Information Center

    Axelsson, Inge; Marnetoft, Sven-Uno

    2010-01-01

    The aim of this study was to try to identify those randomized controlled trials that compare sick leave with no sick leave or a different duration or degree of sick leave. A comprehensive, systematic, electronic search of Clinical Evidence, the Cochrane Library and PubMed, and a manual search of the Campbell Library and a journal supplement was…

  16. Reconsidering Findings of "No Effects" in Randomized Control Trials: Modeling Differences in Treatment Impacts

    ERIC Educational Resources Information Center

    Chaney, Bradford

    2016-01-01

    The primary technique that many researchers use to analyze data from randomized control trials (RCTs)--detecting the average treatment effect (ATE)--imposes assumptions upon the data that often are not correct. Both theory and past research suggest that treatments may have significant impacts on subgroups even when showing no overall effect.…

  17. An Empirical Comparison of Randomized Control Trials and Regression Discontinuity Estimations

    ERIC Educational Resources Information Center

    Barrera-Osorio, Felipe; Filmer, Deon; McIntyre, Joe

    2014-01-01

    Randomized controlled trials (RCTs) and regression discontinuity (RD) studies both provide estimates of causal effects. A major difference between the two is that RD only estimates local average treatment effects (LATE) near the cutoff point of the forcing variable. This has been cited as a drawback to RD designs (Cook & Wong, 2008).…

  18. Thinking outside the Randomized Controlled Trials Experimental Box: Strategies for Enhancing Credibility and Social Justice

    ERIC Educational Resources Information Center

    Hesse-Biber, Sharlene

    2013-01-01

    Some evaluators employ randomized controlled trials (RCTs) as the gold standard of evidence-based practice (EBP). Critics of RCT designs argue that RCTs do not include the complexity of program participants' experiences or clinical expertise, and couple this with criticisms that it is difficult to transfer RCT findings from the laboratory to…

  19. A Randomized Controlled Trial of Koru: A Mindfulness Program for College Students and Other Emerging Adults

    ERIC Educational Resources Information Center

    Greeson, Jeffrey M.; Juberg, Michael K.; Maytan, Margaret; James, Kiera; Rogers, Holly

    2014-01-01

    Objective: To evaluate the effectiveness of Koru, a mindfulness training program for college students and other emerging adults. Participants: Ninety students (66% female, 62% white, 71% graduate students) participated between Fall 2012 and Spring 2013. Methods: Randomized controlled trial. It was hypothesized that Koru, compared with a wait-list…

  20. Learning What Works in ITS from Non-Traditional Randomized Controlled Trial Data

    ERIC Educational Resources Information Center

    Pardos, Zachary A.; Dailey, Matthew D.; Heffernan, Neil T.

    2011-01-01

    The well established, gold standard approach to finding out what works in education research is to run a randomized controlled trial (RCT) using a standard pre-test and post-test design. RCTs have been used in the intelligent tutoring community for decades to determine which questions and tutorial feedback work best. Practically speaking, however,…