Field evaluation of the Off! Clip-on Mosquito Repellent (metofluthrin) against Aedes albopictus and Aedes taeniorhynchus (Diptera: Culicidae) in northeastern Florida.

PubMed

Xue, Rui-De; Qualls, Whitney A; Smith, Michael L; Gaines, Marcia K; Weaver, James H; Debboun, Mustapha

2012-05-01

Repellent efficacy of the Off! Clip-on Mosquito Repellent device (S. C. Johnson and Son, Inc., Racine, WI) containing Metofluthrin was evaluated on six human volunteers against the container-breeding mosquito Aedes albopictus (Skuse) and the salt marsh mosquito Aedes taeniorhynchus (Wiedemann) at two field locations in northeastern Florida. The device repelled mosquitoes by releasing a vaporized form of the pyrethroid insecticide metofluthrin ([AI] 31.2%) and provided 70% protection from Ae. albopictus bites for > 3 h. For the second field trial, a repellent device that was used in the first trial was tested after being open for >1 wk. This device provided 79% protection from Ae. taeniorhynchus bites for 3 h. Our field results showed that the repellent device was 70 and 79% effective at repelling Ae. albopictus and Ae. taeniorhynchus from human test subjects in both field locations in northeastern Florida.

An Applied-Scientific Approach to Field Assessments - Try It Out - A Field Guide for Practitioners (Une approche scientifique des evaluations de terrain - Essayer le - Un guide de terrain a destination des praticiens)

DTIC Science & Technology

2017-12-01

settings – be it field trials, field experiments, tests or evaluations . This guide is based on experience of the the NATO STO Task Group (HFM-211...practice by the Task Group. Feedback from defence colleges and Training and Evaluation staffs is highly welcomed. ES - 2 STO-TR-HFM-211 Une... evaluation programs have been setup to analyse and demonstrate the added value and effectiveness of new developments such as new operational concepts, new

PILOT TESTING: PRETREATMENT OPTIONS TO ALLOW RE-USE OF FRAC FLOWBACK AND PRODUCED BRINE FOR GAS SHALE RESOURCE DEVELOPMENT

DOE Office of Scientific and Technical Information (OSTI.GOV)

Burnett, David

2012-12-31

The goal of the A&M DOE NETL Project No. DE-FE0000847 was to develop a mobile, multifunctional water treatment capability designed specifically for “pre-treatment” of field waste brine. The project consisted of constructing s mobile “field laboratory” incorporating new technology for treating high salinity produced water and using the lab to conduct a side-by-side comparison between this new technology and that already existing in field operations. A series of four field trials were performed utilizing the mobile unit to demonstrate the effectiveness of different technology suitable for use with high salinity flow back brines and produced water. The design of themore » mobile unit was based on previous and current work at the Texas A&M Separation Sciences Pilot Plant. The several treatment techniques which have been found to be successful in both pilot plant and field tests had been tested to incorporate into a single multifunctional process train. Eight different components were evaluated during the trials, two types of oil and grease removal, one BTEX removal step, three micro-filters, and two different nanofilters. The performance of each technique was measured by its separation efficiency, power consumption, and ability to withstand fouling. The field trials were a success. Four different field brines were evaluated in the first trial in New York. Over 16,000 gallons of brine were processed. Using a power cost of $.10 per kWh, media pretreatment power use averaged $0.004 per barrel, solids removal $.04 per barrel and brine “softening” $.84 per barrel. Total power cost was approximately $1.00 per barrel of fluid treated. In Pennsylvania, brines collected from frac ponds were tested in two additional trials. Each of the brines was converted to an oil-free, solids-free brine with no biological activity. Brines were stable over time and would be good candidates for use as a make-up fluid in a subsequent fracturing fluid design. Reports on all of the field trials and subcontractor research have been summarized in this Final Report. Individual field trial reports and research reports are contained in the companion volume titled “Appendices”« less

Optical fiber reliability results from the Biarritz field trial

NASA Astrophysics Data System (ADS)

Gouronnec, Alain; Goarin, Rolland; Le Moigne, G.; Baptiste, M.

1994-09-01

The first experimental optical fiber network (fiber to the home CATV and video-phone) was installed in BIARRITZ, France) at the beginning or 1980. Some parts of the first optical links have now been removed. FRANCE TELECOM decided to stop field trial services, it appeared interesting to evaluate and expertise fiber reliability after more than 10 years of aging in a real adverse field environment. In this paper we give a short description of the layed down links, and indicate how we have carefully removed the individual fibers from the cables. After a first measurement of the mechanical parameters using normalized dynamic and static tests, we compared the results obtained with those of the equivalent tests used to evaluate these fibers before their installation on the field. The tests used are the same than those used in the 80 th. In conclusion, the paper gives the ageing results measured on the BIARRITZ optical fibers after more than 10 years of service in real environment and evaluate it by comparison with the results before installation.

Evaluation of boric acid sugar baits against Aedes albopictus (Diptera: Culicidae) in tropical environments.

PubMed

Naranjo, Diana P; Qualls, Whitney A; Müller, Gunter C; Samson, Dayana M; Roque, Deborah; Alimi, Temitope; Arheart, Kristopher; Beier, John C; Xue, Rui-De

2013-04-01

Attractive toxic sugar bait (active ingredient, 1% boric acid) was evaluated against Aedes albopictus Skuse populations in the laboratory, semi-field trials, and field trials in residential communities in St. Augustine, Florida. Laboratory evaluations of boric acid sugar baits applied to the plant Pentas lanceolata (Rubiaceae) demonstrated 100 and 92% mortality of A. albopictus at day 7 and 14, respectively. A semi-field study evaluating the bait application to the upperside or topside of leaves resulted in no significant difference on mortality (P>0.05). Overall combined top and bottom boric acid sugar bait application mortality at day 7 was 95% based on leaf bioassays. Field application of the boric acid sugar baits significantly (P<0.05) decreased adult A. albopictus populations up to day 21 post-treatment compared to the pre-treatment population numbers. A significant reduction in oviposition was demonstrated both at day 7 and 14 post-application (P=0.001) as monitored by ovitraps. Attractive toxic sugar bait application in tropical environments demonstrated efficacy, persistence, and feasibility in controlling A. albopictus populations.

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.

COMPUTERIZED EXPERT SYSTEM FOR EVALUATION OF AUTOMATED VISUAL FIELDS FROM THE ISCHEMIC OPTIC NEUROPATHY DECOMPRESSION TRIAL: METHODS, BASELINE FIELDS, AND SIX-MONTH LONGITUDINAL FOLLOW-UP

PubMed Central

Feldon, Steven E

2004-01-01

ABSTRACT Purpose To validate a computerized expert system evaluating visual fields in a prospective clinical trial, the Ischemic Optic Neuropathy Decompression Trial (IONDT). To identify the pattern and within-pattern severity of field defects for study eyes at baseline and 6-month follow-up. Design Humphrey visual field (HVF) change was used as the outcome measure for a prospective, randomized, multi-center trial to test the null hypothesis that optic nerve sheath decompression was ineffective in treating nonarteritic anterior ischemic optic neuropathy and to ascertain the natural history of the disease. Methods An expert panel established criteria for the type and severity of visual field defects. Using these criteria, a rule-based computerized expert system interpreted HVF from baseline and 6-month visits for patients randomized to surgery or careful follow-up and for patients who were not randomized. Results A computerized expert system was devised and validated. The system was then used to analyze HVFs. The pattern of defects found at baseline for patients randomized to surgery did not differ from that of patients randomized to careful follow-up. The most common pattern of defect was a superior and inferior arcuate with central scotoma for randomized eyes (19.2%) and a superior and inferior arcuate for nonrandomized eyes (30.6%). Field patterns at 6 months and baseline were not different. For randomized study eyes, the superior altitudinal defects improved (P = .03), as did the inferior altitudinal defects (P = .01). For nonrandomized study eyes, only the inferior altitudinal defects improved (P = .02). No treatment effect was noted. Conclusions A novel rule-based expert system successfully interpreted visual field defects at baseline of eyes enrolled in the IONDT. PMID:15747764

In Defense of the Randomized Controlled Trial for Health Promotion Research

PubMed Central

Rosen, Laura; Manor, Orly; Engelhard, Dan; Zucker, David

2006-01-01

The overwhelming evidence about the role lifestyle plays in mortality, morbidity, and quality of life has pushed the young field of modern health promotion to center stage. The field is beset with intense debate about appropriate evaluation methodologies. Increasingly, randomized designs are considered inappropriate for health promotion research. We have reviewed criticisms against randomized trials that raise philosophical and practical issues, and we will show how most of these criticisms can be overcome with minor design modifications. By providing rebuttal to arguments against randomized trials, our work contributes to building a sound methodological base for health promotion research. PMID:16735622

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.

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

2008-12-09

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.

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

PubMed

Yano, Tsuneo; Watanabe, Yasuyoshi

2010-10-01

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

Laboratory bioassays and field-cage trials of Metarhizium spp. isolates with field-collected Mormon crickets (Anabrus simplex)

USDA-ARS?s Scientific Manuscript database

The Mormon cricket, Anabrus simplex, is an important pest in the western United States. This study evaluates the virulence of 32 isolates of Metarhizium towards field-collected Mormon crickets. Additionally, several isolates were tested in outdoor field-cage studies. All 32 Metarhizium isolates were...

Field and laboratory evaluations of commercial and next–generation alumina-forming austenitic foil for advanced recuperators

DOE PAGES

Pint, Bruce A.; Dryepondt, Sebastien N.; Brady, Michael P.; ...

2016-07-19

Alumina-forming austenitic (AFA) steels represent a new class of corrosion- and creep-resistant austenitic steels designed to enable higher temperature recuperators. Field trials are in progress for commercially rolled foil with widths over 39 cm. The first trial completed 3000 hrs in a microturbine recuperator with an elevated turbine inlet temperature and showed limited degradation. A longer microturbine trial is in progress. A third exposure in a larger turbine has passed 16,000 hrs. Furthermore, to reduce alloy cost and address foil fabrication issues with the initial AFA composition, several new AFA compositions are being evaluated in creep and laboratory oxidation testingmore » at 650–800 °C and the results compared to commercially fabricated AFA foil and conventional recuperator foil performance.« less

The Use of Ebola Convalescent Plasma to Treat Ebola Virus Disease in Resource-Constrained Settings: A Perspective From the Field

PubMed Central

van Griensven, Johan; De Weiggheleire, Anja; Delamou, Alexandre; Smith, Peter G.; Edwards, Tansy; Vandekerckhove, Philippe; Bah, Elhadj Ibrahima; Colebunders, Robert; Herve, Isola; Lazaygues, Catherine; Haba, Nyankoye; Lynen, Lutgarde

2016-01-01

The clinical evaluation of convalescent plasma (CP) for the treatment of Ebola virus disease (EVD) in the current outbreak, predominantly affecting Guinea, Sierra Leone, and Liberia, was prioritized by the World Health Organization in September 2014. In each of these countries, nonrandomized comparative clinical trials were initiated. The Ebola-Tx trial in Conakry, Guinea, enrolled 102 patients by 7 July 2015; no severe adverse reactions were noted. The Ebola-CP trial in Sierra Leone and the EVD001 trial in Liberia have included few patients. Although no efficacy data are available yet, current field experience supports the safety, acceptability, and feasibility of CP as EVD treatment. Longer-term follow-up as well as data from nontrial settings and evidence on the scalability of the intervention are required. CP sourced from within the outbreak is the most readily available source of anti-EVD antibodies. Until the advent of effective antivirals or monoclonal antibodies, CP merits further evaluation. PMID:26261205

Pediatric Cardiovascular Clinical Trials: An Analysis of ClinicalTrials.gov and the Food and Drug Administration Pediatric Drug Labeling Database

PubMed Central

Hill, Kevin D.; Henderson, Heather T.; Hornik, Christoph P.; Li, Jennifer S.

2015-01-01

Recent regulatory initiatives in the United States and Europe have transformed the pediatric clinical trials landscape by significantly increasing capital investment and pediatric trial volume. The purpose of this manuscript is to review the impact of these initiatives on the pediatric cardiovascular trials landscape when compared to other pediatric sub-specialties. We also evaluate factors that may have contributed to the success or failure of recent major pediatric cardiovascular trials so as to inform the optimal design and conduct of future trials in the field. PMID:26377725

Paediatric cardiovascular clinical trials: an analysis of ClinicalTrials.gov and the Food and Drug Administration Pediatric Drug Labeling Database.

PubMed

Hill, Kevin D; Henderson, Heather T; Hornik, Christoph P; Li, Jennifer S

2015-08-01

Recent regulatory initiatives in the United States of America and Europe have transformed the paediatric clinical trials landscape by significantly increasing capital investment and paediatric trial volume. The purpose of this manuscript was to review the impact of these initiatives on the paediatric cardiovascular trials landscape when compared with other paediatric sub-specialties. We also evaluate factors that may have contributed to the success or failure of recent major paediatric cardiovascular trials so as to inform the optimal design and conduct of future trials in the field.

Entomopathogenic potential of Trichoderma longibrachiatum and its comparative evaluation with malathion against the insect pest Leucinodes orbonalis.

PubMed

Ghosh, Swapan Kr; Pal, Sujoy

2016-01-01

The widespread use of chemical pesticides in agriculture has led to the pollution of environmental systems and has caused various health disorders in animals and humans. Biological pest control is one of the most environmentally friendly methods in modern agriscience. Such methods protect crops from pests and do not pollute the environment. A strain of Trichoderma longibrachiatum was isolated and identified from the soil environment of the North 24 Parganas District, eastern India. A spore suspension of this fungus was used to treat Leucinodes orbonalis, one of the major pests of brinjal (eggplant, Solanum melongena). In an in vitro system, fungal antagonism was determined by median lethal dose (LD50) and median lethal time (LT50) tests against insect larvae. The LD50 and LT50 of T. longibrachiatum were 2.87 × 10(7) spores ml(-1) and 11.7 days, respectively. T. longibrachiatum was formulated into a biopesticide, and its performance was evaluated in brinjal field trials in 2012 and 2013. In the field trials, brinjal treated with three spray applications of T. longibrachiatum (10(8) spores/ml) at 15-day intervals showed a 56.02 % higher crop yield than that of the control. This treatment showed similar efficacy to that of the pesticide malathion in the field trials. The results of this study indicate that this formulation may replace malathion to control the insect pest L. orbonalis in brinjal crops. This is the first report of the entomopathogenic property of T. longibrachiatum and its evaluation against an insect pest in field trials.

Grafting and Paladin™ Pic-21 for nematode and weed management in vegetable production

USDA-ARS?s Scientific Manuscript database

Field trials were conducted over two years in a Meloidogyne incognita-infested field to evaluate the combined use of grafting and Paladin™ (DMDS:chloropicrin) for root-knot nematode and weed control in tomato and melon. Tomato rootstocks evaluated were; ‘TX301’, ‘Multifort’, and ‘Aloha’. ‘Florida 47...

Ft. Collins Sugar Beet Germplasm Evaluated for Resistance to Rhizomania and Storability in Idaho, 2010

USDA-ARS?s Scientific Manuscript database

Sugar beet germplasm and commercial check cultivars were evaluated in a sprinkler-irrigated sugar beet field near Kimberly, ID where sugar beet was grown in 2009. The field trial relied on natural inoculum for rhizomania development. The seed was treated with clothianidin (2.1 oz a.i. per 100,000 ...

Cost and accuracy of advanced breeding trial designs in apple

PubMed Central

Harshman, Julia M; Evans, Kate M; Hardner, Craig M

2016-01-01

Trialing advanced candidates in tree fruit crops is expensive due to the long-term nature of the planting and labor-intensive evaluations required to make selection decisions. How closely the trait evaluations approximate the true trait value needs balancing with the cost of the program. Designs of field trials of advanced apple candidates in which reduced number of locations, the number of years and the number of harvests per year were modeled to investigate the effect on the cost and accuracy in an operational breeding program. The aim was to find designs that would allow evaluation of the most additional candidates while sacrificing the least accuracy. Critical percentage difference, response to selection, and correlated response were used to examine changes in accuracy of trait evaluations. For the quality traits evaluated, accuracy and response to selection were not substantially reduced for most trial designs. Risk management influences the decision to change trial design, and some designs had greater risk associated with them. Balancing cost and accuracy with risk yields valuable insight into advanced breeding trial design. The methods outlined in this analysis would be well suited to other horticultural crop breeding programs. PMID:27019717

Determining the Primary Endpoint for a Stimulant Abuse Trial: Lessons Learned from STRIDE (CTN 0037)

PubMed Central

Trivedi, Madhukar H.; Greer, Tracy L.; Potter, Jennifer Sharpe; Grannemann, Bruce D.; Nunes, Edward V.; Rethorst, Chad; Warden, Diane; Ring, Kolette M.; Somoza, Eugene

2012-01-01

Background No consensus is available for identifying the best primary outcome for substance abuse trials. While abstinence is the most desirable outcome for substance use interventions, a wide variety of other endpoints have been used to evaluate efficacy trials. Objectives This report provides a framework for determining an optimal primary endpoint and the relevant measurement approach for substance use disorder treatment trials. The framework was developed based on a trial for stimulant abuse using exercise as an augmentation treatment, delivered within the NIDA Clinical Trials Network. The use of a common primary endpoint across trials will facilitate comparisons of treatment efficacy. Methods Primary endpoint options in existing substance abuse studies were evaluated. This evaluation included surveys of the literature for endpoints and measurement approaches, followed by assessment of endpoint choices against study design issues, population characteristics, tests of sensitivity and tests of clinical meaningfulness. Conclusion We concluded that the best current choice for a primary endpoint is percent days abstinent, as measured by the Time Line Follow Back (TLFB) interview conducted three times a week with recall aided by a take-home Substance Use Diary. To further improve the accuracy of the self-reported drug use, an algorithm will be applied to reconcile the results from the TLFB with the results of qualitative urine drug screens. Scientific Significance There is a need for a standardized endpoint in this field to allow for comparison across treatment studies, and we suggest that the recommended endpoint be considered for use in this field. PMID:21854276

Field evaluation of porous asphalt pavement

DOT National Transportation Integrated Search

2004-05-01

This report summarizes the construction and early performance of a field trial of a Porous Friction Course (PFC) in Indiana. The PFC is compared to an adjacent section of Stone Matrix Asphalt (SMA) constructed at the same time using the same binder, ...

Field trials of medical decision-aids: potential problems and solutions.

PubMed Central

Wyatt, J.; Spiegelhalter, D.

1991-01-01

Only clinical trials can assess the impact of prototype medical decision-aids, but they are seldom performed before dissemination. Many problems are encountered when designing such studies, including ensuring generality, deciding what to measure, feasible study designs, correcting for biases caused by the trial itself and by the decision-aid, resolving the "Evaluation Paradox", and potential legal and ethical doubts. These are discussed in this paper. PMID:1807610

CONSIDERATIONS FOR INNOVATIVE REMEDIATION TECHNOLOGY EVALUATION SAMPLING PLANS

EPA Science Inventory

Field trials of innovative subsurface cleanup technologies require the use of integrated site characterization approaches to obtain critical design parameters, to evaluate pre-treatment contaminant distributions, and to assess process efficiency. This review focuses on the trans...

Considerations in the Efficacy and Effectiveness of Virtual Reality Interventions for Stroke Rehabilitation: Moving the Field Forward

PubMed Central

Lange, Belinda

2015-01-01

In the past 2 decades, researchers have demonstrated the potential for virtual reality (VR) technologies to provide engaging and motivating environments for stroke rehabilitation interventions. Much of the research has been focused on the exploratory phase, and jumps to intervention efficacy trials and scale-up evaluation have been made with limited understanding of the active ingredients in a VR intervention for stroke. The rapid pace of technology development is an additional challenge for this emerging field, providing a moving target for researchers developing and evaluating potential VR technologies. Recent advances in customized games and cutting-edge technology used for VR are beginning to allow for researchers to understand and control aspects of the intervention related to motivation, engagement, and motor control and learning. This article argues for researchers to take a progressive, step-wise approach through the stages of intervention development using evidence-based principles, take advantage of the data that can be obtained, and utilize measurement tools to design effective VR interventions for stroke rehabilitation that can be assessed through carefully designed efficacy and effectiveness trials. This article is motivated by the recent calls in the field of rehabilitation clinical trials research for carefully structured clinical trials that have progressed through the phases of research. PMID:25343960

Considerations in the efficacy and effectiveness of virtual reality interventions for stroke rehabilitation: moving the field forward.

PubMed

Proffitt, Rachel; Lange, Belinda

2015-03-01

In the past 2 decades, researchers have demonstrated the potential for virtual reality (VR) technologies to provide engaging and motivating environments for stroke rehabilitation interventions. Much of the research has been focused on the exploratory phase, and jumps to intervention efficacy trials and scale-up evaluation have been made with limited understanding of the active ingredients in a VR intervention for stroke. The rapid pace of technology development is an additional challenge for this emerging field, providing a moving target for researchers developing and evaluating potential VR technologies. Recent advances in customized games and cutting-edge technology used for VR are beginning to allow for researchers to understand and control aspects of the intervention related to motivation, engagement, and motor control and learning. This article argues for researchers to take a progressive, step-wise approach through the stages of intervention development using evidence-based principles, take advantage of the data that can be obtained, and utilize measurement tools to design effective VR interventions for stroke rehabilitation that can be assessed through carefully designed efficacy and effectiveness trials. This article is motivated by the recent calls in the field of rehabilitation clinical trials research for carefully structured clinical trials that have progressed through the phases of research. © 2015 American Physical Therapy Association.

Development and evaluation of strategies to reduce the incidence of deer-vehicle collisions (phase III) : operational field trail, part A.

DOT National Transportation Integrated Search

2014-11-01

To better understand deer movements that might contribute to deer-vehicle collisions (DVC), we conducted preparatory field work : necessary for an operational field trial of the efficacy of a 1.2-m woven-wire fence with a top-mounted outrigger. We wo...

Clinical trials in palliative care: a systematic review of their methodological characteristics and of the quality of their reporting.

PubMed

Bouça-Machado, Raquel; Rosário, Madalena; Alarcão, Joana; Correia-Guedes, Leonor; Abreu, Daisy; Ferreira, Joaquim J

2017-01-25

Over the past decades there has been a significant increase in the number of published clinical trials in palliative care. However, empirical evidence suggests that there are methodological problems in the design and conduct of studies, which raises questions about the validity and generalisability of the results and of the strength of the available evidence. We sought to evaluate the methodological characteristics and assess the quality of reporting of clinical trials in palliative care. We performed a systematic review of published clinical trials assessing therapeutic interventions in palliative care. Trials were identified using MEDLINE (from its inception to February 2015). We assessed methodological characteristics and describe the quality of reporting using the Cochrane Risk of Bias tool. We retrieved 107 studies. The most common medical field studied was oncology, and 43.9% of trials evaluated pharmacological interventions. Symptom control and physical dimensions (e.g. intervention on pain, breathlessness, nausea) were the palliative care-specific issues most studied. We found under-reporting of key information in particular on random sequence generation, allocation concealment, and blinding. While the number of clinical trials in palliative care has increased over time, methodological quality remains suboptimal. This compromises the quality of studies. Therefore, a greater effort is needed to enable the appropriate performance of future studies and increase the robustness of evidence-based medicine in this important field.

The assessment of field trials in GMO research around the world and their possible integration in field trials for variety registration.

PubMed

Slot, M M; van de Wiel, C C M; Kleter, G A; Visser, R G F; Kok, E J

2018-05-04

Most regulations worldwide stipulate that a new genetically modified (GM) crop event has to be compared to its closest non-GM counterpart as a corner stone of the pre-market risk assessment. To this end the GM crop and its comparator should be grown in field trials for a phenotypic comparison as well as for subsequent detailed analysis of the composition of the two crop varieties. A more in-depth globally harmonised approach for the conduct of these field trials is lacking. Only a few countries have formulated detailed protocols for the set-up of GM field trials. In some countries, commercial non-GM reference varieties need to be included in a field study to compile reliable data that indicate the range of natural variation for the compounds tested at the specific location. Detailed analysis of pre-market assessment reports have so far not shown the added value of including these reference varieties in the field trials. In all cases where specific values were found to be outside of the range of the reference varieties, it proved possible to draw conclusions on the part of the pre-market risk assessment that relates to the compositional analysis, on the basis of already available compositional data. With the increasing quality of several databases on compositional data of a growing number of crop species, it seems unlikely that reference varieties will become more important on future occasions. It was furthermore investigated whether this part of the risk assessment can be related to field trial requirements for variety registration with the explicit intention of reducing the data burden on producers of new GM plant varieties. Field trials for variety registration so far include an assessment of phenotypic characteristics that do not cover safety aspects, with the exception of establishment of the glycoalkaloid content in potatoes in the Netherlands and Sweden. It may, however, under certain conditions be relatively easy to exchange data from compositional measurements between variety registration and GM testing procedures, thus laying a foundation for testing the feasibility of combining both pre-market assessment procedures in a single pre-market evaluation path.

The influence of large clinical trials in orthopedic trauma: do they change practice?

PubMed

Khan, Hassan; Hussain, Nasir; Bhandari, Mohit

2013-12-01

To evaluate the influence of top fracture trials on the practice of orthopedic surgeons. This is a cross-sectional study. We electronically administered the survey to all members of the Canadian Orthopedic Association. We received responses for 222 surveys, of which, 178 surveys were completed. We distributed a survey that evaluated the influence of 7 important fracture studies (6 randomized controlled trials and 1 prospective cohort study) on practice, patient care and the overall advancement of knowledge in the field of orthopedics. This study was approved by our local ethics review board. The primary outcome measure was the perceived general influence and impact of important fracture studies on the perceptions and practice of orthopedic surgeons. The Clavicular Fixation Trial (2007) and Tibial Fracture Trial (SPRINT, 2008) were perceived by surgeons to have the greatest influence on advancing overall knowledge in the field, improving personal practice, and the most influence on improving patient care. On the other hand, the Bone Stimulation in Fractures Trial (2011) and the recombinant human bone morphogenetic protein-2-BESST Trial (2002) had the lowest mean influence ranks. The probability of changing practice was significantly higher (Odds Ratio, 2.89; 95% confidence interval, 2.16-3.88; P < 0.00001) when studies had positive outcomes in comparison with negative outcomes. Despite the complexity and costs associated with clinical trials in orthopedic trauma, the results from this survey suggest that these studies result in a demonstrable perceived influence and impact on the practice of orthopedic surgeons.

Field evaluations of waterproof membrane systems for bridge decks, 1972-1974.

DOT National Transportation Integrated Search

1975-01-01

Waterproof membrane systems are being studied by many agencies from the standpoint of their effectiveness in protecting the reinforcing steel in concrete bridge decks against corrosion. Trial applications and evaluations of six such systems, includin...

Competency to stand trial evaluations: a study of actual practice in two states.

PubMed

Robbins, E; Waters, J; Herbert, P

1997-01-01

A criminal defendant must be competent to stand trial (CST) to safeguard the fundamental right to a fair trial. If there is a question as to a defendant's ability to assist in his or her own defense, a mental health professional is asked to perform a CST evaluation. Forensic assessment is a growing field, and CST is the most frequent evaluation requested. Over the years, forensic examiners' reports to the courts have been criticized for lack of relevance, insufficiency, and invading the province of the judge. If mental health professionals wish to advance the field of forensic assessment and respond to these criticisms, research on current practice with suggestions for advancement are necessary. A total of 66 CST reports conducted within the last five years in two states were compared to a proposed model for CST assessment. Results indicated that although forensic examiners are maintaining legal relevance, some CST reports may lack thoroughness and/or provide information that exceeds their role responsibilities. The findings support the need for the development of a standardized method of conducting and writing CST evaluations that should improve the quality of such reports.

The case for introducing pre-registered confirmatory pharmacological pre-clinical studies.

PubMed

Kiwanuka, Olivia; Bellander, Bo-Michael; Hånell, Anders

2018-05-01

When evaluating the design of pre-clinical studies in the field of traumatic brain injury, we found substantial differences compared to phase III clinical trials, which in part may explain the difficulties in translating promising experimental drugs into approved treatments. By using network analysis, we also found cases where a large proportion of the studies evaluating a pre-clinical treatment was performed by inter-related researchers, which is potentially problematic. Subjecting all pre-clinical trials to the rigor of a phase III clinical trial is, however, likely not practically achievable. Instead, we repeat the call for a distinction to be made between exploratory and confirmatory pre-clinical studies.

Microbial control of Agrilus planipennis (Coleoptera: Buprestidae) with Beauveria bassiana strain GHA: field applications

Treesearch

Houping Liu; Leah S. Bauer

2008-01-01

The effects of Beauveria bassiana strain GHA, applied as BotaniGard ES, on newly colonised and well-established populations of emerald ash borer, Agrilus planipennis (Coleoptera: Buprestidae) were evaluated in the field using foliar and trunk sprays in Michigan in 2004-2005. Results from field trials at a newly colonised white ash...

Larvicidal effect of disinfectant soap on Anopheles gambiae s.s (Diptera: Culicidae) in laboratory and semifield environs

PubMed Central

2014-01-01

Background Mosquito larval control using chemicals and biological agents is of paramount importance in vector population and disease incidence reduction. A commercial synthetic disinfectant soap was evaluated against larvae of Anopheles gambiae s.s. in both laboratory and semi field conditions. Method Five concentrations of commercial synthetic disinfectant soap (0.0001, 0.001, 0.01, 0.1 and 1%) were prepared and evaluated against third instar larvae in laboratory and semi field environments. Mortality was scored at 12, 24, 48, and 72 hrs. Each dosage had 6 replicates, having twenty 3rd instar larvae of An.gambiae s.s. Results In the laboratory phase, all dosages had significantly higher larval mortalities than in controls, while in semi field conditions, the dosages of 0.0001, 0.001 and 0.01% had lower mortalities than laboratory trials. In the comparison between semi field and laboratory trials, only 0.1 and 1% dosage had significant difference with more mortality in semifield conditions. Proportions of larvae that died during mortality monitoring intervals in laboratory and semi field had significant differences only at 12 hrs and 72 hrs. Conclusion The findings of this study have demonstrated that the mortality of larvae caused by commercial synthetic disinfectant soap is worth further studies in open water bodies. More studies are necessary to find out the effect of sunlight on the chemistry of the synthetic disinfectant and other variables in small scale full field trials. PMID:24885903

Larvicidal effect of disinfectant soap on Anopheles gambiae s.s (Diptera: Culicidae) in laboratory and semifield environs.

PubMed

Mdoe, France P; Nkwengulila, Gamba; Chobu, Mariam; Lyaruu, Lucile; Gyunda, Israel L; Mbepera, Saada; Xue, Rui-De; Kweka, Eliningaya J

2014-05-03

Mosquito larval control using chemicals and biological agents is of paramount importance in vector population and disease incidence reduction. A commercial synthetic disinfectant soap was evaluated against larvae of Anopheles gambiae s.s. in both laboratory and semi field conditions. Five concentrations of commercial synthetic disinfectant soap (0.0001, 0.001, 0.01, 0.1 and 1%) were prepared and evaluated against third instar larvae in laboratory and semi field environments. Mortality was scored at 12, 24, 48, and 72 hrs. Each dosage had 6 replicates, having twenty 3rd instar larvae of An.gambiae s.s. In the laboratory phase, all dosages had significantly higher larval mortalities than in controls, while in semi field conditions, the dosages of 0.0001, 0.001 and 0.01% had lower mortalities than laboratory trials. In the comparison between semi field and laboratory trials, only 0.1 and 1% dosage had significant difference with more mortality in semifield conditions. Proportions of larvae that died during mortality monitoring intervals in laboratory and semi field had significant differences only at 12 hrs and 72 hrs. The findings of this study have demonstrated that the mortality of larvae caused by commercial synthetic disinfectant soap is worth further studies in open water bodies. More studies are necessary to find out the effect of sunlight on the chemistry of the synthetic disinfectant and other variables in small scale full field trials.

Steep cut slope composting : field trials and evaluation : project summary report.

DOT National Transportation Integrated Search

2011-04-01

This project is a continuation of earlier work performed by Montana State University (Jennings et al. 2007) evaluating compost application on, and incorporation into, soils on steep cut slopes for the Montana Department of Transportation (MDT). The e...

Impact of Different Visual Field Testing Paradigms on Sample Size Requirements for Glaucoma Clinical Trials.

PubMed

Wu, Zhichao; Medeiros, Felipe A

2018-03-20

Visual field testing is an important endpoint in glaucoma clinical trials, and the testing paradigm used can have a significant impact on the sample size requirements. To investigate this, this study included 353 eyes of 247 glaucoma patients seen over a 3-year period to extract real-world visual field rates of change and variability estimates to provide sample size estimates from computer simulations. The clinical trial scenario assumed that a new treatment was added to one of two groups that were both under routine clinical care, with various treatment effects examined. Three different visual field testing paradigms were evaluated: a) evenly spaced testing, b) United Kingdom Glaucoma Treatment Study (UKGTS) follow-up scheme, which adds clustered tests at the beginning and end of follow-up in addition to evenly spaced testing, and c) clustered testing paradigm, with clusters of tests at the beginning and end of the trial period and two intermediary visits. The sample size requirements were reduced by 17-19% and 39-40% using the UKGTS and clustered testing paradigms, respectively, when compared to the evenly spaced approach. These findings highlight how the clustered testing paradigm can substantially reduce sample size requirements and improve the feasibility of future glaucoma clinical trials.

Evaluation of field-produced hot mix asphalt (HMA) mixtures with fractionated recycled asphalt pavement (RAP) : 2007 Illinois tollway field mix trials.

DOT National Transportation Integrated Search

2008-10-01

To test the fractionated recycled asphalt pavement (FRAP) materials, the Illinois Tollway, working through its : contractors and consultants, developed and conducted a project on the applicability and feasibility of using : increased RAP contents thr...

Realized gains from block-plot coastal Douglas-fir trials in the northern Oregon Cascades

Treesearch

Terrence Z. Ye; Keith J.S. Jayawickrama; J. Bradley St. Clair

2010-01-01

Realized gains for coastal Douglas-fir (Pseudotsuga menziesii var. menziesii) were evaluated using data collected from 15-year-old trees from five field trials planted in large block plots in the northern Oregon Cascades. Three populations with different genetic levels (elite--high predicted gain; intermediate--moderate predicted gain; and an...

Ethical issues in field trials of genetically modified disease-resistant mosquitoes.

PubMed

Resnik, David B

2014-04-01

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. Published 2012. This article is a US Government work and is in the public domain in the USA.

GRAFTING FOR CONTROL OF MELOIDOGYNE INCOGNITA ON BELL PEPPER, TOMATO, AND MELONS

USDA-ARS?s Scientific Manuscript database

Greenhouse, microplot, and field trials were conducted over three-years to evaluate rootstocks for root-knot nematode (Meloidogyne incognita) resistance. Rootstocks were evaluated for bell pepper (Capsicum annuum), tomato (Solanum esculentum), cantaloupe (Cucumis melo), and watermelon (Citrullus lan...

A data grid for imaging-based clinical trials

NASA Astrophysics Data System (ADS)

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

2007-03-01

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

Percutaneous Coronary Intervention of Left Main Disease: Pre- and Post-EXCEL (Evaluation of XIENCE Everolimus Eluting Stent Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) and NOBLE (Nordic-Baltic-British Left Main Revascularization Study) Era.

PubMed

Park, Duk-Woo; Park, Seung-Jung

2017-06-01

For nearly half a century, coronary artery bypass grafting has been the standard treatment for patients with obstructive left main coronary artery (LMCA) disease. However, there has been considerable evolution in the field of percutaneous coronary intervention, and especially, percutaneous coronary intervention for LMCA disease has been rapidly expanded with adoption of drug-eluting stents. Some, but not all randomized trials, have shown that percutaneous coronary intervention with drug-eluting stents might be a suitable alternative for selected patients with LMCA disease instead of bypass surgery. However, none of previous trials involving early-generation drug-eluting stents was sufficiently powered and comparative trials using contemporary drug-eluting stents were limited. Recently, primary results of 2 new trials of EXCEL (Evaluation of XIENCE Everolimus Eluting Stent Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) and NOBLE (Nordic-Baltic-British Left Main Revascularization Study) were reported. However, these trials showed conflicting results, which might pose uncertainty on the optimal revascularization strategy for LMCA disease. In this article, with the incorporation of a key review on evolution of LMCA treatment, we summarize the similarity or disparity of the EXCEL and NOBLE trials, focus on how they relate to previous trials in the field, and finally speculate on how the treatment strategy may be changed or recommended for LMCA treatment. © 2017 American Heart Association, Inc.

Estimates of genetic parameters and environmental effects for measures of hunting performance in Finnish hounds.

PubMed

Liinamo, A E; Karjalainen, L; Ojala, M; Vilva, V

1997-03-01

Data from field trials of Finnish Hounds between 1988 and 1992 in Finland were used to estimate genetic parameters and environmental effects for measures of hunting performance using REML procedures and an animal model. The original data set included 28,791 field trial records from 5,666 dogs. Males and females had equal hunting performance, whereas experience acquired by age improved trial results compared with results for young dogs (P < .001). Results were mostly better on snow than on bare ground (P < .001), and testing areas, years, months, and their interactions affected results (P < .001). Estimates of heritabilities and repeatabilities were low for most of the 28 measures, mainly due to large residual variances. The highest heritabilities were for frequency of tonguing (h2 = .15), pursuit score (h2 = .13), tongue score (h2 = .13), ghost trailing score (h2 = .12), and merit and final score (both h2 = .11). Estimates of phenotypic and genetic correlations were positive and moderate or high for search scores, pursuit scores, and final scores but lower for other studied measures. The results suggest that, due to low heritabilities, evaluation of breeding values for Finnish Hounds with respect to their hunting ability should be based on animal model BLUP methods instead of mere performance testing. The evaluation system of field trials should also be revised for more reliability.

Clinical trials involving positron emission tomography and prostate cancer: an analysis of the ClinicalTrials.gov database.

PubMed

Cihoric, Nikola; Vlaskou Badra, Eugenia; Tsikkinis, Alexandros; Prasad, Vikas; Kroeze, Stephanie; Igrutinovic, Ivan; Jeremic, Branislav; Beck, Marcus; Zschaeck, Sebastian; Wust, Peter; Ghadjar, Pirus

2018-06-18

The goal of this study is to evaluate the status and future perspectives of clinical trials on positron emission tomography in prostate cancer for diagnostic or therapeutic as well as for surveillance purposes. The www.ClinicalTrials.gov database was searched on the 20th of January 2017 for all trials containing terms describing "prostate cancer" (prostate, prostatic, malignant, malignancy, cancer, tumor) and "positron emission tomography". In total 167 trials were identified. Trials that included diseases other than PCa were excluded (n = 27; 16%). Furthermore, we excluded trials (n = 4, 2%) withdrawn prior to first patient enrollment. The remaining trials (n = 137, 82%) were selected for further manual classification analysis. One hundred thirty-seven trials were detected and analyzed. Majority of trials were in "active" recruitment status (n = 46, 34%) followed by trials that had been "completed" - (n = 34, 25%) and trials with "closed recruitment but active follow-up" (n = 23, 17%). Phase 1 and 2 comprised 46% of the complete trial portfolio. Locally confined disease was of major interest (n = 46, 34%), followed by metastatic disease - not otherwise specified (n = 43, 13%). Evaluation of PET was the primary goal of the trial in 114 (83%) cases. Most of the trials evaluated only one agent (n = 122, 89%). Choline and PSMA represented two major groups (total 50%) and they were equally distributed across trial portfolio with 25% (n = 34) each. PSMA trials showed the highest average annual growth rate of 56%. The trials were conducted in 17 countries. The scientific community is showing a strong and ever-growing interest in the field and we expect that in the coming years, more phase III trials will be initiated ultimately delivering the required Level 1 evidence.

Extended Wearing Trial of Trifield Lens Device for “Tunnel Vision”

PubMed Central

Woods, Russell L.; Giorgi, Robert G.; Berson, Eliot L.; Peli, Eli

2009-01-01

Severe visual field constriction (tunnel vision) impairs the ability to navigate and walk safely. We evaluated Trifield glasses as a mobility rehabilitation device for tunnel vision in an extended wearing trial. Twelve patients with tunnel vision (5 to 22 degrees wide) due to retinitis pigmentosa or choroideremia participated in the 5-visit wearing trial. To expand the horizontal visual field, one spectacle lens was fitted with two apex-to-apex prisms that vertically bisected the pupil on primary gaze. This provides visual field expansion at the expense of visual confusion (two objects with the same visual direction). Patients were asked to wear these spectacles as much as possible for the duration of the wearing trial (median 8, range 6 to 60, weeks). Clinical success (continued wear, indicating perceived overall benefit), visual field expansion, perceived direction and perceived visual ability were measured. Of 12 patients, 9 chose to continue wearing the Trifield glasses at the end of the wearing trial. Of those 9 patients, at long-term follow-up (35 to 78 weeks), 3 reported still wearing the Trifield glasses. Visual field expansion (median 18, range 9 to 38, degrees) was demonstrated for all patients. No patient demonstrated adaptation to the change in visual direction produced by the Trifield glasses (prisms). For difficulty with obstacles, some differences between successful and non-successful wearers were found. Trifield glasses provided reported benefits in obstacle avoidance to 7 of the 12 patients completing the wearing trial. Crowded environments were particularly difficult for most wearers. Possible reasons for long-term discontinuation and lack of adaptation to perceived direction are discussed. PMID:20444130

Extended wearing trial of Trifield lens device for 'tunnel vision'.

PubMed

Woods, Russell L; Giorgi, Robert G; Berson, Eliot L; Peli, Eli

2010-05-01

Severe visual field constriction (tunnel vision) impairs the ability to navigate and walk safely. We evaluated Trifield glasses as a mobility rehabilitation device for tunnel vision in an extended wearing trial. Twelve patients with tunnel vision (5-22 degrees wide) due to retinitis pigmentosa or choroideremia participated in the 5-visit wearing trial. To expand the horizontal visual field, one spectacle lens was fitted with two apex-to-apex prisms that vertically bisected the pupil on primary gaze. This provides visual field expansion at the expense of visual confusion (two objects with the same visual direction). Patients were asked to wear these spectacles as much as possible for the duration of the wearing trial (median 8, range 6-60 weeks). Clinical success (continued wear, indicating perceived overall benefit), visual field expansion, perceived direction and perceived visual ability were measured. Of 12 patients, nine chose to continue wearing the Trifield glasses at the end of the wearing trial. Of those nine patients, at long-term follow-up (35-78 weeks), three reported still wearing the Trifield glasses. Visual field expansion (median 18, range 9-38 degrees) was demonstrated for all patients. No patient demonstrated adaptation to the change in visual direction produced by the Trifield glasses (prisms). For reported difficulty with obstacles, some differences between successful and non-successful wearers were found. Trifield glasses provided reported benefits in obstacle avoidance to 7 of the 12 patients completing the wearing trial. Crowded environments were particularly difficult for most wearers. Possible reasons for long-term discontinuation and lack of adaptation to perceived direction are discussed.

Soybean Resistance to White Mold: Evaluation of Soybean Germplasm Under Different Conditions and Validation of QTL

PubMed Central

Kandel, Ramkrishna; Chen, Charles Y.; Grau, Craig R.; Dorrance, Ann E.; Liu, Jean Q.; Wang, Yang; Wang, Dechun

2018-01-01

Soybean (Glycine max L. Merr.) white mold (SWM), caused by Sclerotinia sclerotiorum (Lib) de Barry), is a devastating fungal disease in the Upper Midwest of the United States and southern Canada. Various methods exist to evaluate for SWM resistance and many quantitative trait loci (QTL) with minor effect governing SWM resistance have been identified in prior studies. This study aimed to predict field resistance to SWM using low-cost and efficient greenhouse inoculation methods and to confirm the QTL reported in previous studies. Three related but independent studies were conducted in the field, greenhouse, and laboratory to evaluate for SWM resistance. The first study evaluated 66 soybean plant introductions (PIs) with known field resistance to SWM using the greenhouse drop-mycelium inoculation method. These 66 PIs were significantly (P < 0.043) different for resistance to SWM. However, year was highly significant (P < 0.00001), while PI x year interaction was not significant (P < 0.623). The second study compared plant mortality (PM) of 35 soybean breeding lines or varieties in greenhouse inoculation methods with disease severity index (DSI) in field evaluations. Moderate correlation (r) between PM under drop-mycelium method and DSI in field trials (r = 0.65, p < 0.0001) was obtained. The PM under spray-mycelium was also correlated significantly with DSI from field trials (r = 0.51, p < 0.0018). Likewise, significant correlation (r = 0.62, p < 0.0001) was obtained between PM across greenhouse inoculation methods and DSI across field trials. These findings suggest that greenhouse inoculation methods could predict the field resistance to SWM. The third study attempted to validate 33 QTL reported in prior studies using seven populations that comprised a total of 392 F4 : 6 lines derived from crosses involving a partially resistant cultivar “Skylla,” five partially resistant PIs, and a known susceptible cultivar “E00290.” The estimates of broad-sense heritability (h2) ranged from 0.39 to 0.66 in the populations. Of the seven populations, four had h2 estimates that were significantly different from zero (p < 0.05). Single marker analysis across populations and inoculation methods identified 11 significant SSRs (p < 0.05) corresponding to 10 QTL identified by prior studies. Thus, these five new PIs could be used as new sources of resistant alleles to develop SWM resistant commercial cultivars. PMID:29731761

Ten years later: Evaluation of the effectiveness of 12.5% amitraz against a field population of Rhipicephalus (Boophilus) microplus using field studies, artificial infestation (Stall tests) and adult immersion tests.

PubMed

Maciel, Willian Giquelin; Lopes, Welber Daniel Zanetti; Cruz, Breno Cayeiro; Gomes, Lucas Vinicius Costa; Teixeira, Weslen Fabrício Pires; Buzzulini, Carolina; Bichuette, Murilo Abud; Campos, Gabriel Pimentel; Felippelli, Gustavo; Soares, Vando Edésio; de Oliveira, Gilson Pereira; da Costa, Alvimar José

2015-12-15

Using field trials, artificial infestations (Stall tests) and in vitro adult immersion tests, the present study evaluated the acaricidal efficacy of 12.5% amitraz administered via whole body spraying against a Rhipicephalus (Boophilus) microplus population that did not have any contact with chemical products belonging to this acaricide family for 10 years (approximately 40 generations). Two natural infestation trials, two artificial infestation trials (Stall tests) and two adult immersion tests were performed in two different stages in 2005 and 2015. Between 2002 and 2015, the bovine herd of this property was formed by approximately 450 animals from the Simmental breed that were divided into nine paddocks formed by Cynodon dactylon (L.) Pers. For the natural infestation experiments in 2005 and 2015, we selected nearly 70 animals naturally infested with ticks from the same herd that belonged to the "São Paulo" farm located in São José do Rio Pardo, São Paulo, Brazil. Field studies were performed in the same paddock (9). To evaluate anti-R. (B.) microplus activity in the artificially infested cattle (Stall tests) and adult immersion tests, two experiments of each methodology were performed at CPPAR (the Center of Research in Animal Health located on the FCAV/UNESP campus in Jaboticabal, São Paulo, Brazil) in 2005 and 2015. R. (B.) microplus used in the artificial infestation, and adult immersion test experiments were obtained from paddocks 1-9 in 2005 and 2015 from the commercial farm where the field studies were performed. Based on the obtained results, it was possible to conclude that amitraz use in rotation with pyrethroids every 28 days for three consecutive years (2002-2004) previous to the beginning of the first trial (2005) was sufficient to generate a R. (B.) microplus strain resistant to amitraz. Moreover, using field trials, artificial infestations (Stall tests) and adult immersion tests, we verified that 40 generations of the tick species with no contact to the aforementioned compound (amitraz) were not sufficient to revert or modify the efficacy/resistance of amitraz for this analyzed R. (B.) microplus strain. The reversion of amitraz efficacy values in R. (B.) microplus may only occur when resistance of the field strain is incipient. Alternatively, the differences in the results may be due to differences in the Rhipicephalus spp. species between current study locations. Therefore, future studies must be performed to prove this hypothesis. Copyright © 2015 Elsevier B.V. All rights reserved.

Genetic analysis without replications: Model evaluation and application in spring wheat

USDA-ARS?s Scientific Manuscript database

Genetic data collected from plant breeding and genetic studies may not be replicated in field designs even though field variation is present. In this study, we addressed this problem using spring wheat (Triticum eastivum L.) trial data collected from two locations. There were no intra-location repl...

Long term field evaluation reveals HLB resistance in Citrus relatives

USDA-ARS?s Scientific Manuscript database

Citrus huanglongbing (HLB) is a destructive disease with no known cure. To identify sources of HLB resistance in the subfamily Aurantioideae to which citrus belongs, we conducted a six-year field trial under natural disease challenge conditions in an HLB endemic region. The study included 65 Citrus ...

Analyzing Empirical Evaluations of Non-Experimental Methods in Field Settings

ERIC Educational Resources Information Center

Steiner, Peter M.; Wong, Vivian

2016-01-01

Despite recent emphasis on the use of randomized control trials (RCTs) for evaluating education interventions, in most areas of education research, observational methods remain the dominant approach for assessing program effects. Over the last three decades, the within-study comparison (WSC) design has emerged as a method for evaluating the…

Validation of the DIFFAL, HPAC and HotSpot Dispersion Models Using the Full-Scale Radiological Dispersal Device (FSRDD) Field Trials Witness Plate Deposition Dataset.

PubMed

Purves, Murray; Parkes, David

2016-05-01

Three atmospheric dispersion models--DIFFAL, HPAC, and HotSpot--of differing complexities have been validated against the witness plate deposition dataset taken during the Full-Scale Radiological Dispersal Device (FSRDD) Field Trials. The small-scale nature of these trials in comparison to many other historical radiological dispersion trials provides a unique opportunity to evaluate the near-field performance of the models considered. This paper performs validation of these models using two graphical methods of comparison: deposition contour plots and hotline profile graphs. All of the models tested are assessed to perform well, especially considering that previous model developments and validations have been focused on larger-scale scenarios. Of the models, HPAC generally produced the most accurate results, especially at locations within ∼100 m of GZ. Features present within the observed data, such as hot spots, were not well modeled by any of the codes considered. Additionally, it was found that an increase in the complexity of the meteorological data input to the models did not necessarily lead to an improvement in model accuracy; this is potentially due to the small-scale nature of the trials.

Making history: Thomas Francis, Jr, MD, and the 1954 Salk Poliomyelitis Vaccine Field Trial.

PubMed

Lambert, S M; Markel, H

2000-05-01

This article focuses on the poliomyelitis vaccine field trial directed by Thomas Francis,Jr, MD, of the University of Michigan Vaccine Evaluation Center and sponsored by the National Foundation for Infantile Paralysis (NFIP) or, as it was better known to the public, the March of Dimes. It was a landmark in the widescale testing of a vaccine and the ethical use of human subjects. Millions of American parents readily volunteered their healthy children to participate. A total of 150,000 volunteers, including schoolteachers, physicians, nurses, and health officers all endorsed the study and donated their time and effort to make it successful. Avoiding the use of marginalized groups, the field trial purposefully did not involve institutionalized children; instead, it was based in 15,000 public schools in 44 of the 48 states as clinic sites. A group of 650,000 children received some type of injection, either the vaccine or a placebo, and another 1.18 million served as controls. The field trial depended, most essentially, on both public support and the participation of millions of children who remained enrolled in a study that required a series of 3 injections and a 6-month evaluation period. Enlisting the huge number of participants presented practical examples of the difficulties in experimenting on human subjects. On April 26, 1954, Randy Kerr, a participant or "Polio Pioneer" as the children involved were called, received the first inoculation of the Salk poliomyelitis vaccine. The nationwide study "designed to test the safety and efficacy" of the Salk vaccine had officially begun.

Performance of polymer modified hot mix asphalt pavements : an extended evaluation.

DOT National Transportation Integrated Search

2004-03-01

In the summer of 1996, the Mississippi Department of Transportation (MDOT) initiated a field trial (MDOT : State Study No. 111) and a laboratory study (MDOT State Study No. 123) to evaluate the use of polymer : modified asphalts in hot mix asphalt pa...

Sampling efficiency of the Moore egg collector

USGS Publications Warehouse

Worthington, Thomas A.; Brewer, Shannon K.; Grabowski, Timothy B.; Mueller, Julia

2013-01-01

Quantitative studies focusing on the collection of semibuoyant fish eggs, which are associated with a pelagic broadcast-spawning reproductive strategy, are often conducted to evaluate reproductive success. Many of the fishes in this reproductive guild have suffered significant reductions in range and abundance. However, the efficiency of the sampling gear used to evaluate reproduction is often unknown and renders interpretation of the data from these studies difficult. Our objective was to assess the efficiency of a modified Moore egg collector (MEC) using field and laboratory trials. Gear efficiency was assessed by releasing a known quantity of gellan beads with a specific gravity similar to that of eggs from representatives of this reproductive guild (e.g., the Arkansas River Shiner Notropis girardi) into an outdoor flume and recording recaptures. We also used field trials to determine how discharge and release location influenced gear efficiency given current methodological approaches. The flume trials indicated that gear efficiency ranged between 0.0% and 9.5% (n = 57) in a simple 1.83-m-wide channel and was positively related to discharge. Efficiency in the field trials was lower, ranging between 0.0% and 3.6%, and was negatively related to bead release distance from the MEC and discharge. The flume trials indicated that the gellan beads were not distributed uniformly across the channel, although aggregation was reduced at higher discharges. This clustering of passively drifting particles should be considered when selecting placement sites for an MEC; further, the use of multiple devices may be warranted in channels with multiple areas of concentrated flow.

Effects of inulin-type fructans, galacto-oligosaccharides and related synbiotics on inflammatory markers in adult patients with overweight or obesity: A systematic review.

PubMed

Fernandes, Ricardo; do Rosario, Vinicius A; Mocellin, Michel C; Kuntz, Marilyn G F; Trindade, Erasmo B S M

2017-10-01

Studies in humans with overweight or obesity have reported that some prebiotics and synbiotics have beneficial effects on metabolic endotoxaemia and immune function. However, to date, no systematic review of controlled clinical trials assessed this topic. The aim of this study was to evaluate the effects of inulin-type fructans, galacto-oligosaccharides and related synbiotics on inflammatory markers in adults with overweight or obesity. A systematic review of the literature was performed until November 6, 2015 in four electronic databases and reference lists of all included articles and relevant reviews in the field, without using any filter. Ten trials (six prebiotic and four synbiotic trials) representing 534 overweight/obese adults were included. All trials evaluated C-reactive protein or high-sensitivity C-reactive protein, four trials evaluated cytokines (two prebiotic and two synbiotic trials) and five trials evaluated endotoxin (four prebiotic and one synbiotic trials). Six trials (two with galacto-oligosaccharide, one with inulin and three with different synbiotics) showed a reduction on high-sensitivity C-reactive protein. Four trials (one with oligofructose-enriched inulin, one with inulin and two with different synbiotics) showed a reduction on interleukin-6 and/or tumor necrosis factor. Four trials (one with galacto-oligosaccharide, one with oligofructose-enriched inulin, one with inulin and one with synbiotic) showed a reduction on endotoxin. Some prebiotics and synbiotics may have immunomodulatory action, however, more randomized controlled trials are needed to support the clinical use of inulin-type fructans, galacto-oligosaccharides or related synbiotics for the treatment of metabolic endotoxaemia or low-grade inflammation in overweight/obese people. Copyright © 2016 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Selection of nontarget arthropod taxa for field research on transgenic insecticidal crops: using empirical data and statistical power.

PubMed

Prasifka, J R; Hellmich, R L; Dively, G P; Higgins, L S; Dixon, P M; Duan, J J

2008-02-01

One of the possible adverse effects of transgenic insecticidal crops is the unintended decline in the abundance of nontarget arthropods. Field trials designed to evaluate potential nontarget effects can be more complex than expected because decisions to conduct field trials and the selection of taxa to include are not always guided by the results of laboratory tests. Also, recent studies emphasize the potential for indirect effects (adverse impacts to nontarget arthropods without feeding directly on plant tissues), which are difficult to predict because of interactions among nontarget arthropods, target pests, and transgenic crops. As a consequence, field studies may attempt to monitor expansive lists of arthropod taxa, making the design of such broad studies more difficult and reducing the likelihood of detecting any negative effects that might be present. To improve the taxonomic focus and statistical rigor of future studies, existing field data and corresponding power analysis may provide useful guidance. Analysis of control data from several nontarget field trials using repeated-measures designs suggests that while detection of small effects may require considerable increases in replication, there are taxa from different ecological roles that are sampled effectively using standard methods. The use of statistical power to guide selection of taxa for nontarget trials reflects scientists' inability to predict the complex interactions among arthropod taxa, particularly when laboratory trials fail to provide guidance on which groups are more likely to be affected. However, scientists still may exercise judgment, including taxa that are not included in or supported by power analyses.

Disruption of Darna pallivitta (Lepidoptera: Limacodidae) by Conventional and Mobile Pheromone Deployment

PubMed Central

Siderhurst, Matthew S.; Jang, Eric B.; Carvalho, Lori A. F. N.; Nagata, Janice T.; Derstine, Nathan T.

2015-01-01

Identification of the Darna pallivitta (Moore) pheromone component n-butyl (E)-7,9-decadienoate (E7,9-10:COOn-Bu) has made it possible to investigate communication disruption to control this lepidopteran pest. Conventional communication disruption trials showed marked decreases in the mean number of male moths captured in E7,9-10:COOnBu-treated fields compared with control fields. For traps baited with E7,9-10:COOnBu, percent disruptions were 94.4% and 92.1% for septa (1 g pheromone/ha, 1-wk trial duration) and spirals (6 g pheromone/ha, 8-wk trial duration) respectively. For traps baited with virgin female moths, percent disruption was 73.3% using septa disruptors (1 g pheromone/ha, 1-wk trial duration). Mobile communication disruption using Bactrocera cucurbitae (Coquillett) as carriers for E7,9-10:COOn-Bu was evaluated in the following three areas: fly survivorship, attraction of male moths to treated flies, and moth disruption in a small-scale field trial. Topical application of E7,9-10:COOnBu showed no significant decrease in survivorship at 50 and 80 µg/fly. However, decreased survivorship was observed at 100 µg/fly and linear regression showed E7,9-10:COOnBu dose was significantly correlated with B. cucurbitae survivorship. Traps containing honey–pheromone-fed flies attracted and caught D. pallivitta over a 1-wk period, demonstrating the attractiveness of the carrier. Releasing E7,9-10:COOnBu-fed B. cucurbitae (∼2 g pheromone/ha, 1-wk trial duration) resulted in significantly reduced trap catches in treatment fields compared with control fields on the first 2 d of the field trial. Percent disruptions were 84.7% (day 1) and 56.0% (day 2). These results suggest that both conventional communication disruption and mobile communication disruption have potential to control D. pallivitta. PMID:26078301

Disruption of Darna pallivitta (Lepidoptera: Limacodidae) by Conventional and Mobile Pheromone Deployment.

PubMed

Siderhurst, Matthew S; Jang, Eric B; Carvalho, Lori A F N; Nagata, Janice T; Derstine, Nathan T

2015-01-01

Identification of the Darna pallivitta (Moore) pheromone component n-butyl (E)-7,9-decadienoate (E7,9-10:COOn-Bu) has made it possible to investigate communication disruption to control this lepidopteran pest. Conventional communication disruption trials showed marked decreases in the mean number of male moths captured in E7,9-10:COOnBu-treated fields compared with control fields. For traps baited with E7,9-10:COOnBu, percent disruptions were 94.4% and 92.1% for septa (1 g pheromone/ha, 1-wk trial duration) and spirals (6 g pheromone/ha, 8-wk trial duration) respectively. For traps baited with virgin female moths, percent disruption was 73.3% using septa disruptors (1 g pheromone/ha, 1-wk trial duration). Mobile communication disruption using Bactrocera cucurbitae (Coquillett) as carriers for E7,9-10:COOn-Bu was evaluated in the following three areas: fly survivorship, attraction of male moths to treated flies, and moth disruption in a small-scale field trial. Topical application of E7,9-10:COOnBu showed no significant decrease in survivorship at 50 and 80 µg/fly. However, decreased survivorship was observed at 100 µg/fly and linear regression showed E7,9-10:COOnBu dose was significantly correlated with B. cucurbitae survivorship. Traps containing honey-pheromone-fed flies attracted and caught D. pallivitta over a 1-wk period, demonstrating the attractiveness of the carrier. Releasing E7,9-10:COOnBu-fed B. cucurbitae (∼2 g pheromone/ha, 1-wk trial duration) resulted in significantly reduced trap catches in treatment fields compared with control fields on the first 2 d of the field trial. Percent disruptions were 84.7% (day 1) and 56.0% (day 2). These results suggest that both conventional communication disruption and mobile communication disruption have potential to control D. pallivitta. © The Author 2015. Published by Oxford University Press on behalf of the Entomological Society of America.

Smartphone application for multi-phasic interventional trials in psychiatry: Technical design of a smart server.

PubMed

Zhang, Melvyn W B; Ho, Roger C M

2017-01-01

Smartphones and their accompanying applications are currently widely utilized in various healthcare interventions. Prior to the deployment of these tools for healthcare intervention, typically, proof of concept feasibility studies, as well as randomized trials are conducted to determine that these tools are efficacious prior to their actual implementation. In the field of psychiatry, most of the current interventions seek to compare smartphone based intervention against conventional care. There remains a paucity of research evaluating different forms of interventions using a single smartphone application. In the field of nutrition, there has been recent pioneering research demonstrating how a multi-phasic randomized controlled trial could be conducted using a single smartphone application. Despite the innovativeness of the previous smartphone conceptualization, there remains a paucity of technical information underlying the conceptualization that would support a multi-phasic interventional trial. It is thus the aim of the current technical note to share insights into an innovative server design that would enable the delivery of multi-phasic trials.

Twenty-year perspective of randomized controlled trials for surgery of chronic nonspecific low back pain: citation bias and tangential knowledge.

PubMed

Andrade, Nicholas S; Flynn, John P; Bartanusz, Viktor

2013-11-01

After decades of clinical research, the role of surgery for chronic nonspecific low back pain (CNLBP) remains equivocal. Despite significant intellectual, human, and economic investments into randomized controlled trials (RCTs) in the past two decades, the role of surgery in the treatment for CNLBP has not been clarified. To delineate the historical research agenda of surgical RCTs for CNLBP performed between 1993 and 2012 investigating whether conclusions from earlier published trials influenced the choice of research questions of subsequent RCTs on elucidating the role of surgery in the management of CNLBP. Literature review. We searched the literature for all RCTs involving surgery for CNLBP. We reviewed relevant studies to identify the study question, comparator arms, and sample size. Randomized controlled trials were classified as "indication" trials if they evaluated the effectiveness of surgical therapy versus nonoperative care or as "technical" if they compared different surgical techniques, adjuncts, or procedures. We used citation analysis to determine the impact of trials on subsequent research in the field. Altogether 33 technical RCTs (3,790 patients) and 6 indication RCTs (981 patients) have been performed. Since 2007, despite the unclear benefits of surgery reported by the first four indication trials published in 2001 to 2006, technical trials have continued to predominate (16 vs. 2). Of the technical trials, types of instrumentation (13 trials, 1,332 patients), bone graft materials and substitutes (11 trials, 833 patients), and disc arthroplasty versus fusion (5 trials, 1,337 patients) were the most common comparisons made. Surgeon authors have predominantly cited one of the indication trials that reported more favorable results for surgery, despite a lack of superior methodology or sample size. Trials evaluating bone morphogenic protein, instrumentation, and disc arthroplasty were all cited more frequently than the largest trial of surgical versus nonsurgical therapy. The research agenda of RCTs for surgery of CNLBP has not changed substantially in the last 20 years. Technical trials evaluating nuances of surgical techniques significantly predominate. Despite the publication of four RCTs reporting equivocal benefits of surgery for CNLBP between 2001 and 2006, there was no change in the research agenda of subsequent RCTs, and technical trials continued to outnumber indication trials. Rather than clarifying what, if any, indications for surgery exist, investigators in the field continue to analyze variations in surgical technique, which will probably have relatively little impact on patient outcomes. As a result, clinicians unfortunately have little evidence to advise patients regarding surgical intervention for CNLBP. Copyright © 2013 Elsevier Inc. All rights reserved.

Design of telehealth trials--introducing adaptive approaches.

PubMed

Law, Lisa M; Wason, James M S

2014-12-01

The field of telehealth and telemedicine is expanding as the need to improve efficiency of health care becomes more pressing. The decision to implement a telehealth system is generally an expensive undertaking that impacts a large number of patients and other stakeholders. It is therefore extremely important that the decision is fully supported by accurate evaluation of telehealth interventions. Numerous reviews of telehealth have described the evidence base as inconsistent. In response they call for larger, more rigorously controlled trials, and trials which go beyond evaluation of clinical effectiveness alone. The aim of this paper is to discuss various ways in which evaluation of telehealth could be improved by the use of adaptive trial designs. We discuss various adaptive design options, such as sample size reviews and changing the study hypothesis to address uncertain parameters, group sequential trials and multi-arm multi-stage trials to improve efficiency, and enrichment designs to maximise the chances of obtaining clear evidence about the telehealth intervention. There is potential to address the flaws discussed in the telehealth literature through the adoption of adaptive approaches to trial design. Such designs could lead to improvements in efficiency, allow the evaluation of multiple telehealth interventions in a cost-effective way, or accurately assess a range of endpoints that are important in the overall success of a telehealth programme. Copyright © 2014 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Taking transgenic rice drought screening to the field.

PubMed

Gaudin, Amélie C M; Henry, Amelia; Sparks, Adam H; Slamet-Loedin, Inez H

2013-01-01

Numerous transgenes have been reported to increase rice drought resistance, mostly in small-scale experiments under vegetative-stage drought stress, but few studies have included grain yield or field evaluations. Different definitions of drought resistance are currently in use for field-based and laboratory evaluations of transgenics, the former emphasizing plant responses that may not be linked to yield under drought. Although those fundamental studies use efficient protocols to uncover and validate gene functions, screening conditions differ greatly from field drought environments where the onset of drought stress symptoms is slow (2-3 weeks). Simplified screening methods, including severely stressed survival studies, are therefore not likely to identify transgenic events with better yield performance under drought in the target environment. As biosafety regulations are becoming established to allow field trials in some rice-producing countries, there is a need to develop relevant screening procedures that scale from preliminary event selection to greenhouse and field trials. Multilocation testing in a range of drought environments may reveal that different transgenes are necessary for different types of drought-prone field conditions. We describe here a pipeline to improve the selection efficiency and reproducibility of results across drought treatments and test the potential of transgenic rice for the development of drought-resistant material for agricultural purposes.

Field Trial of Attenuated Salmonella Typhi Live Oral Vaccine TY21A in Liquid and Enteric-Coated Formulations and Epidemiological Survey for Incidence of Diarrhea due to Shigella Species

DTIC Science & Technology

1989-03-01

and absolute efficacy of three doses of Ty2la vaccine given in enteric-coated capsule or liquid formulation. Intensive clinical and bacteriologic...TABLES Table 1. Evaluation of the efficacy of three doses of the enteric-coated capsule formulation of Ty2la live oral vaccine given within one week in...November, 1986 thzough February, 1989 of a field trial in Area Sur Oriente and Area Norte assessing the efficacy of Ty21a vaccine in liquid or enteric

Reporting quality of randomized controlled trials in patients with HIV on antiretroviral therapy: a systematic review.

PubMed

Nagai, Kaori; Saito, Akiko M; Saito, Toshiki I; Kaneko, Noriyo

2017-12-28

To allow for correct evaluation of clinical trial results, readers require comprehensive, clear, and highly transparent information on the methodology used and the results obtained. This study aimed to evaluate the quality of reporting in articles on randomized controlled trials (RCTs) of antiretroviral therapy (ART) in the field of HIV/AIDS. We searched for original articles on RCTs of ART developed in the field of HIV/AIDS in PubMed database by 5 April 2016. Searched articles were divided into three groups based on the revision year in which the Consolidated Standards of Reporting Trials (CONSORT) guidelines were published: Period 1 (1996-2001); Period 2 (2002-2010); and Period 3 (2011-2016). We evaluated the articles using the reporting rates of the 37 items in the CONSORT 2010 checklist, five items in the protocol deviation, and the three items in the ethics. Fifty-two articles were extracted and included in this study. Many of the reporting rates calculated using the CONSORT 2010 checklist showed a significantly increasing trend over the successive periods (65% in Period 1, 67% in Period 2, 79% in Period 3; p < 0.0001). The items with reporting rates < 50% were "the presence or absence of a protocol change and the reason for such a change," "randomization and blinding," and "where the full trial protocol can be accessed." Reporting rates of deviations were as low as < 30%, while the reporting rates for patient compliance were the highest (>80% in Period 3) among the five items. The reporting rates for obtaining informed consent and approval by the ethics committee or institutional review board were high (>88%), regardless of the time period assessed. In terms of representative RCT articles in the field of HIV/AIDS, the reporting rate of the items defined by CONSORT was approximately 70%, improving over the successive CONSORT statement revision periods.

Alternative fumigants and grafting for tomato and double-cropped muskmelon production in Florida

USDA-ARS?s Scientific Manuscript database

A field trial was conducted at the USDA, ARS Farm in Fort Pierce, FL in a field infested with root-knot nematodes (RKN) (Meloidogyne incognita), soil-borne pathogens, and weeds. A split plot experiment with four replications was used to evaluate rootstock/scion combinations in fumigated and herbicid...

Greenhouse and Field Evaluation of the Natural Saponin CAY-1, for Control of Several Strawberry Diseases

USDA-ARS?s Scientific Manuscript database

The steroidal saponin from cayenne pepper, CAY-1, was tested as a potential fungicide in detached leaf assays and field trials. Efficacy of CAY-1 against strawberry anthracnose was compared to the commercial fungicide azoxystrobin. Both fungicides prevented anthracnose leaf lesions when applied to...

Methodological issues in oral health research: intervention studies.

PubMed

O'Mullane, Denis; James, Patrice; Whelton, Helen; Parnell, Carmel

2012-02-01

To provide a broad overview of methodological issues in the design and evaluation of intervention studies in dental public health, with particular emphasis on explanatory trials, pragmatic trials and complex interventions. We present a narrative summary of selected publications from the literature outlining both historical and recent challenges in the design and evaluation of intervention studies and describe some recent tools that may help researchers to address these challenges. It is now recognised that few intervention studies in dental public health are purely explanatory or pragmatic. We describe the PRECIS tool which can be used by trialists to assess and display the position of their trial on a continuum between the extremes of explanatory and pragmatic trials. The tool aims to help trialists make design decisions that are in line with their stated aims. The increasingly complex nature of dental public health interventions presents particular design and evaluation challenges. The revised Medical Research Council (MRC) guidance for the development and evaluation of complex interventions which emphasises the importance of planning and process evaluation is a welcome development. We briefly describe the MRC guidance and outline some examples of complex interventions in the field of oral health. The role of observational studies in monitoring public health interventions when the conduct of RCTs is not appropriate or feasible is acknowledged. We describe the STROBE statement and outline the implications of the STROBE guidelines for dental public health. The methodological challenges in the design, conduct and reporting of intervention studies in oral health are considerable. The need to provide reliable evidence to support innovative new strategies in oral health policy is a major impetus in these fields. No doubt the 'Methodological Issues in Oral Health Research' group will have further opportunities to highlight this work. © 2012 John Wiley & Sons A/S.

Photodynamic therapy trials with lutetium texaphyrin (Lu-Tex) in patients with locally recurrent breast cancer

NASA Astrophysics Data System (ADS)

Renschler, Markus F.; Yuen, Alan R.; Panella, Timothy J.; Wieman, Thomas J.; Dougherty, Shona; Esserman, Laura; Panjehpour, Masoud; Taber, Scott W.; Fingar, Victor H.; Lowe, Elizabeth; Engel, Julie S.; Lum, Bert; Woodburn, Kathryn W.; Cheong, Wai-Fung; Miller, Richard A.

1998-05-01

Photodynamic therapy (PDT) of locally recurrent breast cancer has been limited to treatment of small lesions because of non- selective necrosis of adjacent normal tissues in the treatment field. Lutetium Texaphyrin (PCI-0123, Lu-Tex) is a photosensitizer with improved tumor localization that is activated by 732 nm light, which can penetrate through larger tumors. We have evaluated Lu-Tex in a Phase I trial and in an ongoing Phase II trial in women with locally recurrent breast cancer with large tumors who have failed radiation therapy. Patients received Lu-Tex intravenously by rapid infusion 3 hours before illumination of cutaneous or subcutaneous lesions. In Phase I, Lu-Tex doses were escalated from 0.6 to 7.2 mg/kg in 7 cohorts. Sixteen patients with locally recurrent breast cancer lesions were treated. Dose limiting toxicities above 5.5 mg/kg were pain in the treatment field during therapy, and dysesthesias in light exposed areas. No necrosis of normal tissues in the treated field was noticed. Responses were observed in 60% of evaluable patients [n equals 15, 27% complete remission (CR), 33% partial remission (PR)], with 63% of lesions responding (n equals 73: 45% CR, 18% PR). In Phase II, 25 patients have been studied to date, receiving two treatments ranging from 1.0 to 3.0 mg/kg at a 21 day interval. Treatment fields up to 480 cm2 in size were treated successfully and activity has been observed. Patients have experienced pain at the treatment site but no tissue necrosis. These studies demonstrate the feasibility of Lu-Tex PDT to large chest wall areas in women who have failed radiation therapy for the treatment of locally recurrent breast cancer. Treatment conditions are currently being optimized in the ongoing Phase II trials.

Role of neonicotinyl insecticides in Washington apple integrated pest management. Part I. Control of lepidopteran pests

PubMed Central

Brunner, J. F.; Beers, E. H.; Dunley, J. E.; Doerr, M.; Granger, K.

2005-01-01

Three neonicotinyl insecticides, acetamiprid, thiacloprid and clothianidin, were evaluated for their impact on four species of lepidopteran pests of apple in Washington, the codling moth, Cydia pomonella (L.), the Pandemis leafroller, Pandemis pyrusana Kearfott, and the obliquebanded leafroller, Choristoneura rosaceana (Harris), and Lacanobia subjuncta (Grote & Robinson). None of the neonicotinyl insecticides demonstrated sufficient activity against P. pyrusana, C. rosaceana, or L. subjuncta to warrant field trials. Conversely, all had some activity against one or more stages of C. pomonella. Acetamiprid was highly toxic to larvae in laboratory bioassays, and had relatively long activity of field-aged residues (21 days). It also showed some toxicity to C. pomonella eggs (via topical exposure) and adults. Acetamiprid provided the highest level of fruit protection from C. pomonella attack in field trials conducted over five years in experimental orchards with extremely high codling moth pressure. Thiacloprid performed similarly in bioassays, but fruit protection in field trials was slightly lower than acetamiprid. Clothianidin showed moderate to high toxicity in bioassays, depending on the C. pomonella stage tested, but poor fruit protection from attack in field trials. None of the neonicotinyl insecticides were as toxic to larvae or effective in protecting fruit as the current standard organophosphate insecticide used for C. pomonella control, azinphosmethyl. However, both acetamiprid and thiacloprid should provide acceptable levels of C. pomonella control in commercial orchards where densities are much lower than in the experimental orchards used for our trials. The advantages and disadvantages of the neonicotinyl insecticides as replacements for the organophosphate insecticides and their role in a pest management system for Washington apple orchards are discussed. Abbreviation: MFR Maximum field rate PMID:16341246

Immobilization of swift foxes with ketamine hydrochloride-xylazine hydrochloride

USGS Publications Warehouse

Telesco, R.L.; Sovada, Marsha A.

2002-01-01

There is an increasing need to develop field immobilization techniques that allow researchers to handle safely swift foxes (Vulpes velox) with minimal risk of stress or injury. We immobilized captive swift foxes to determine the safety and effectiveness of ketamine hydrochloride and xylazine hydrochloride at different dosages. We attempted to determine appropriate dosages to immobilize swift foxes for an adequate field-handling period based on three anesthesia intervals (induction period, immobilization period, and recovery period) and physiologic responses (rectal temperature, respiration rate, and heart rate). Between October 1998–July 1999, we conducted four trials, evaluating three different dosage ratios of ketamine and xylazine (2.27:1.2, 5.68:1.2, and 11.4:1.2 mg/kg ketamine:mg/kg xylazine, respectively), followed by a fourth trial with a higher dosage at the median ratio (11.4 mg/kg ketamine:2.4 mg/kg xylazine). We found little difference in induction and recovery periods among trials 1–3, but immobilization time increased with increasing dosage (P<0.08). Both the immobilization period and recovery period increased in trial 4 compared with trials 1–3 (P≤0.03). There was a high variation in responses of individual foxes across trials, making it difficult to identify an appropriate dosage for field handling. Heart rate and respiration rates were depressed but all physiologic measures remained within normal parameters established for domestic canids. We recommend a dosage ratio of 10 mg/kg ketamine to 1 mg/kg xylazine to immobilize swift foxes for field handling.

SOME DESIGN ISSUES IN PHASE 2B VERSUS PHASE 3 PREVENTION TRIALS FOR TESTING EFFICACY OF PRODUCTS OR CONCEPTS

PubMed Central

Gilbert, Peter B.

2009-01-01

SUMMARY After one or more Phase 2 trials show that a candidate preventive vaccine induces immune responses that putatively protect against an infectious disease for which there is no licensed vaccine, the next step is to evaluate the efficacy of the candidate. The trial-designer faces the question of what is the optimal size of the initial efficacy trial? Part of the answer will entail deciding between a large Phase 3 licensure trial or an intermediate-sized Phase 2b screening trial, the latter of which may be designed to directly contribute to the evidence-base for licensing the candidate, or, to test a scientific concept for moving the vaccine field forward, acknowledging that the particular candidate will never be licensable. Using the HIV vaccine field as a case study, we describe distinguishing marks of Phase 2b and Phase 3 prevention efficacy trials, and compare the expected utility of these trial types using Pascal’s decision-theoretic framework. By integrating values/utilities on (1) Correct or incorrect conclusions resulting from the trial; (2) Timeliness of obtaining the trial results; (3) Precision for estimating the intervention effect; and (4) Resources expended; this decision framework provides a more complete approach to selecting the optimal efficacy trial size than a traditional approach that is based primarily on power calculations. Our objective is to help inform the decision-process for planning an initial efficacy trial design. PMID:20419758

Microbial control of emerald ash borer, Agrilus planipennis (Coleoptera: Buprestidae) with Beauveria bassiana strain GHA: Greenhouse and field trials

Treesearch

Houping Liu; Leah S. Bauer

2008-01-01

In 2003-2004, the lethal and sublethal effects of Beauveria bassiana strain GHA on emerald ash borer, Agrilus planipennis (Coleoptera: Buprestidae) adults and larvae were evaluated using topical spray and fungal band treatments in the greenhouse and field. B. bassiana strain GHA was moderately effective against...

Grades of Evidence: Variability in Quality of Findings in Effectiveness Studies of Complex Field Interventions

ERIC Educational Resources Information Center

Chatterji, Madhabi

2007-01-01

This article argues with a literature review that a simplistic distinction between strong and weak evidence hinged on the use of randomized controlled trials (RCTs), the federal "gold standard" for generating rigorous evidence on social programs and policies, is not tenable with evaluative studies of complex, field interventions such as…

Challenges in preparing and implementing a clinical trial at field level in an Ebola emergency: A case study in Guinea, West Africa.

PubMed

Carazo Perez, Sara; Folkesson, Elin; Anglaret, Xavier; Beavogui, Abdoul-Habib; Berbain, Emmanuel; Camara, Alseny-Modet; Depoortere, Evelyn; Lefevre, Annabelle; Maes, Piet; Malme, Kristian Nødtvedt; Malvy, Jean-Marie Denis; Ombelet, Sien; Poelaert, Geertrui; Sissoko, Daouda; Tounkara, Alexis; Trbovic, Pierre; Piguet, Pascal; Antierens, Annick

2017-06-01

During the large Ebola outbreak that affected West Africa in 2014 and 2015, studies were launched to evaluate potential treatments for the disease. A clinical trial to evaluate the effectiveness of the antiviral drug favipiravir was conducted in Guinea. This paper describes the main challenges of the implementation of the trial in the Ebola treatment center of Guéckédou. Following the principles of the Good Clinical Research Practices, we explored the aspects of the community's communication and engagement, ethical conduct, trial protocol compliance, informed consent of participants, ongoing benefit/risk assessment, record keeping, confidentiality of patients and study data, and roles and responsibilities of the actors involved. We concluded that several challenges have to be addressed to successfully implement a clinical trial during an international medical emergency but that the potential for collaboration between research teams and humanitarian organizations needs to be highlighted.

Monetary incentives in support of academic achievement: results of a randomized field trial involving high-achieving, low-resource, ethnically diverse urban adolescents.

PubMed

Spencer, Margaret Beale; Noll, Elizabeth; Cassidy, Elaine

2005-06-01

Significant resources have been directed at understanding and alleviating the achievement gap in education. Most programs focused on this aim rely on a top-down approach, including funding for infrastructure improvement, curriculum development, class size, and teacher salaries. This article presents findings from a randomized field trial that evaluates a bottom-up approach in which high-achieving students of diverse racial and ethnic backgrounds from poor families are given monetary incentives to maintain their academic standing. The evaluation was designed to explore the role of monetary incentives as a mechanism for promoting resiliency in the face of poverty-related challenge. Discussion of what motivates students to learn is framed as a function of normal cognitive and socioemotional development in challenging environments. Evaluation findings indicate that monetary incentives are effective in promoting academic success to different degrees and for different reasons depending on students' perception of the meaning of the incentive in relation to their emergent identity.

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…

Hypothermia for neonatal hypoxic-ischemic encephalopathy: NICHD Neonatal Research Network contribution to the field.

PubMed

Shankaran, Seetha; Natarajan, Girija; Chalak, Lina; Pappas, Athina; McDonald, Scott A; Laptook, Abbot R

2016-10-01

In this article, we summarize the NICHD Neonatal Research Network (NRN) trial of whole-body hypothermia for neonates with hypoxic-ischemic encephalopathy in relation to other randomized controlled trials (RCTs) of hypothermia neuroprotection. We describe the NRN secondary studies that have been published in the past 10 years evaluating clinical, genetic, biochemical, and imaging biomarkers of outcome. Copyright © 2016 Elsevier Inc. All rights reserved.

Type A polymer concrete overlay field trials : final report.

DOT National Transportation Integrated Search

1984-12-01

This report describes placement and subsequent performance of two methyl methacrylate polymer concrete overlays. Performance is evaluated as to: 1) the mixing and placement characteristics of the methyl methacrylate polymer concretes as overlay mater...

Evaluation of a single application of Neonicotnoid and multi-application contact insecticides for flatheaded borer management in field grown Acer rubrum L. cultivars

USDA-ARS?s Scientific Manuscript database

Two trials evaluated insecticides for flatheaded borer (Chrysobothris femorata [Olivier]) control and red maple (Acer rubrum L.) cultivar growth over a 4-year period. Soil-applied systemic insecticides (acephate, imidacloprid, clothianidin, dinotefuran, and thiamethoxam) and trunk-applied contact i...

Evaluation of dry-fleshed sweetpotato genotypes for resistance to soil insect pests, 2012

USDA-ARS?s Scientific Manuscript database

An insect susceptible check cultivar (‘SC1149 19’), an insect resistant check cultivar (‘Ruddy’), 20 advanced dry-fleshed genotypes, and five dry-fleshed cultivars (‘Bonita’, ‘Liberty’, ‘NC Japanese’, ‘Picadito’, and ‘Sumor’) were evaluated for insect resistance in replicated field trials at Charles...

Oncolytic viruses: From bench to bedside with a focus on safety

PubMed Central

Buijs, Pascal RA; Verhagen, Judith HE; van Eijck, Casper HJ; van den Hoogen, Bernadette G

2015-01-01

Oncolytic viruses are a relatively new class of anti-cancer immunotherapy agents. Several viruses have undergone evaluation in clinical trials in the last decades, and the first agent is about to be approved to be used as a novel cancer therapy modality. In the current review, an overview is presented on recent (pre)clinical developments in the field of oncolytic viruses that have previously been or currently are being evaluated in clinical trials. Special attention is given to possible safety issues like toxicity, environmental shedding, mutation and reversion to wildtype virus. PMID:25996182

Methodological and Ethical Challenges in a Web-Based Randomized Controlled Trial of a Domestic Violence Intervention

PubMed Central

Valpied, Jodie; Koziol-McLain, Jane; Glass, Nancy; Hegarty, Kelsey

2017-01-01

The use of Web-based methods to deliver and evaluate interventions is growing in popularity, particularly in a health care context. They have shown particular promise in responding to sensitive or stigmatized issues such as mental health and sexually transmitted infections. In the field of domestic violence (DV), however, the idea of delivering and evaluating interventions via the Web is still relatively new. Little is known about how to successfully navigate several challenges encountered by the researchers while working in this area. This paper uses the case study of I-DECIDE, a Web-based healthy relationship tool and safety decision aid for women experiencing DV, developed in Australia. The I-DECIDE website has recently been evaluated through a randomized controlled trial, and we outline some of the methodological and ethical challenges encountered during recruitment, retention, and evaluation. We suggest that with careful consideration of these issues, randomized controlled trials can be safely conducted via the Web in this sensitive area. PMID:28351830

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

PubMed

Montgomery, C M

2016-08-01

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

Steep cut slope composting : field trials and evaluation.

DOT National Transportation Integrated Search

2011-04-01

Three different depths of compost and five compost retention techniques were tested to determine : their efficacy and cost effectiveness for increasing the establishment of native grass seedings and decreasing : erosion on steep roadside cut slopes i...

Challenges of assessing the clinical efficacy of asexual blood-stage Plasmodium falciparum malaria vaccines.

PubMed

Sheehy, Susanne H; Douglas, Alexander D; Draper, Simon J

2013-09-01

In the absence of any highly effective vaccine candidate against Plasmodium falciparum malaria, it remains imperative for the field to pursue all avenues that may lead to the successful development of such a formulation. The development of a subunit vaccine targeting the asexual blood-stage of Plasmodium falciparum malaria infection has proven particularly challenging with only limited success to date in clinical trials. However, only a fraction of potential blood-stage vaccine antigens have been evaluated as targets, and a number of new promising candidate antigen formulations and delivery platforms are approaching clinical development. It is therefore essential that reliable and sensitive methods of detecting, or ruling out, even modest efficacy of blood-stage vaccines in small clinical trials be established. In this article we evaluate the challenges facing blood-stage vaccine developers, assess the appropriateness and limitations of various in vivo approaches for efficacy assessment and suggest future directions for the field.

Estimating load weights with Huber's Cubic Volume formula: a field trial.

Treesearch

Dale R. Waddell

1989-01-01

Log weights were estimated from the product of Huber's cubic volume formula and green density. Tags showing estimated log weights were attached to logs in the field, and the weights were tallied into a single load weight as logs were assembled for aerial yarding. Accuracy of the estimated load weights was evaluated by comparing the predicted with the actual load...

2017 Update of the field evaluation of new and underutilized fig cultivars for fresh and dried markets

USDA-ARS?s Scientific Manuscript database

There are new and underutilized fig cultivars in the national collection of figs at the National Clonal Germplasm Repository, Davis, CA. This study is a replicated field trial of 12 cultivars that may potentially impact the fresh market and/or dry market fig industry. On April 16, 2015, the fig tree...

Small Cages with Insect Couples Provide a Simple Method for a Preliminary Assessment of Mating Disruption

PubMed Central

Briand, Françoise; Guerin, Patrick M.; Charmillot, Pierre-Joseph; Kehrli, Patrik

2012-01-01

Mating disruption by sex pheromones is a sustainable, effective and widely used pest management scheme. A drawback of this technique is its challenging assessment of effectiveness in the field (e.g., spatial scale, pest density). The aim of this work was to facilitate the evaluation of field-deployed pheromone dispensers. We tested the suitability of small insect field cages for a pre-evaluation of the impact of sex pheromones on mating using the grape moths Eupoecilia ambiguella and Lobesia botrana, two major pests in vineyards. Cages consisted of a cubic metal frame of 35 cm sides, which was covered with a mosquito net of 1500 μm mesh size. Cages were installed in the centre of pheromone-treated and untreated vineyards. In several trials, 1 to 20 couples of grape moths per cage were released for one to three nights. The proportion of mated females was between 15 to 70% lower in pheromone-treated compared to untreated vineyards. Overall, the exposure of eight couples for one night was adequate for comparing different control schemes. Small cages may therefore provide a fast and cheap method to compare the effectiveness of pheromone dispensers under standardised semi-field conditions and may help predict the value of setting-up large-scale field trials. PMID:22645483

Environmental contaminant studies by the Patuxent Wildlife Research Center

USGS Publications Warehouse

Heinz, G.H.; Hill, E.F.; Stickel, W.H.; Stickel, L.F.; Kenaga, E.E.

1979-01-01

Evaluation of the effects of environmental contaminants on wildlife is geared to interpreting events in the field, especially population effects, and both field and laboratory studies are planned for this purpose; procedures are adapted to specific problems and therefore do not include strict protocols or routine testing. Field evaluations include measurements of cholinesterase inhibition in brain or blood, search for dead or disabled animals, study of nesting success of birds, and general ecological observations. Residue analyses are used in evaluating organochlorine chemicals; samples may include whole bodies for determining level of exposure, brains for mortality diagnosis, whole blood for certain special studies, and eggs to help in evaluation of possible reproductive effects. Bird counts, singing-male census counts, small mammal trapping, and cage-in-field tests have proven to be ineffective or misleading and are not considered suitable for field evaluations under most circumstances. Usefulness of simulated field trials is limited to very special situations. Experimental studies that help predict and interpret field effects include determinations of lethal diagnostic levels, comparative lethal dietary toxicity tests, tests of secondary poisoning, measurement of residue loss rates, measurement of blood enzymes, tests of behavioral effects, and studies of reproductive effects.

Field evaluation of a random forest activity classifier for wrist-worn accelerometer data.

PubMed

Pavey, Toby G; Gilson, Nicholas D; Gomersall, Sjaan R; Clark, Bronwyn; Trost, Stewart G

2017-01-01

Wrist-worn accelerometers are convenient to wear and associated with greater wear-time compliance. Previous work has generally relied on choreographed activity trials to train and test classification models. However, validity in free-living contexts is starting to emerge. Study aims were: (1) train and test a random forest activity classifier for wrist accelerometer data; and (2) determine if models trained on laboratory data perform well under free-living conditions. Twenty-one participants (mean age=27.6±6.2) completed seven lab-based activity trials and a 24h free-living trial (N=16). Participants wore a GENEActiv monitor on the non-dominant wrist. Classification models recognising four activity classes (sedentary, stationary+, walking, and running) were trained using time and frequency domain features extracted from 10-s non-overlapping windows. Model performance was evaluated using leave-one-out-cross-validation. Models were implemented using the randomForest package within R. Classifier accuracy during the 24h free living trial was evaluated by calculating agreement with concurrently worn activPAL monitors. Overall classification accuracy for the random forest algorithm was 92.7%. Recognition accuracy for sedentary, stationary+, walking, and running was 80.1%, 95.7%, 91.7%, and 93.7%, respectively for the laboratory protocol. Agreement with the activPAL data (stepping vs. non-stepping) during the 24h free-living trial was excellent and, on average, exceeded 90%. The ICC for stepping time was 0.92 (95% CI=0.75-0.97). However, sensitivity and positive predictive values were modest. Mean bias was 10.3min/d (95% LOA=-46.0 to 25.4min/d). The random forest classifier for wrist accelerometer data yielded accurate group-level predictions under controlled conditions, but was less accurate at identifying stepping verse non-stepping behaviour in free living conditions Future studies should conduct more rigorous field-based evaluations using observation as a criterion measure. Copyright © 2016 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

Sensitivity and Specificity of Proposed "DSM-5" Diagnostic Criteria for Autism Spectrum Disorder

ERIC Educational Resources Information Center

McPartland, James C.; Reichow, Brian; Volkmar, Fred R.

2012-01-01

Objective: This study evaluated the potential impact of proposed "DSM-5" diagnostic criteria for autism spectrum disorder (ASD). Method: The study focused on a sample of 933 participants evaluated during the "DSM-IV" field trial; 657 carried a clinical diagnosis of an ASD, and 276 were diagnosed with a non-autistic disorder. Sensitivity and…

Pilot Evaluation of an Internet Educational Module for Agricultural Safety

ERIC Educational Resources Information Center

Schwab, Charles V.; Freeman, Steven A.

2011-01-01

An important component of the safe operation of agricultural equipment is the ability to read and understand universal symbols. The Internet educational module is designed to help participants recognize these symbols. The impact of using it was evaluated using a field trial study. Assessment consisted of pre- and post-tests. Youth who had access…

Ceratapion basicorne (Illiger) (Coleoptera: Curculionidae): laboratory and open field trials to assess its specificity as biocontrol agent of Centaurea solstitialis (Asteraceae: Cardueae)

USDA-ARS?s Scientific Manuscript database

Prospective biological control agents generally must be demonstrated to not pose risks to non-target plants. Laboratory experiments evaluating host plant specificity are the most common method of evaluating such risk; however, they are constrained by limitations of space and number of replicates, gi...

Field trials of a short-rotation biomass feller buncher and selected harvesting systems

Treesearch

Bryce J. Stokes; Douglas J. Frederick; Dennis T. Curtin

1986-01-01

A continuous-speed felling and bunching prototype machine was evaluated in harvesting a three-year-old, short-rotation sycamore plantation. A small tractor, grapple skidder, and large chipper were evaluate along with the prototype machine as complete harvesting systems. Prediction equations, production rates, and costs were developed for each component of the systems....

Evidence-Based Medicine and Child Mental Health Services: A Broad Approach to Evaluation is Needed.

ERIC Educational Resources Information Center

McGuire, Jacqueline Barnes; And Others

1997-01-01

Describes quasi-experimental designs to be used as alternatives to randomized controlled trials in decisions concerning clinical practice and policy-making in the child mental health field. Highlights importance of taking a systems-level approach to evaluation, and describes ways in which qualitative outcomes measures can be used to sensitively…

A Methodological Analysis of Randomized Clinical Trials of Computer-Assisted Therapies for Psychiatric Disorders: Toward Improved Standards for an Emerging Field

PubMed Central

Kiluk, Brian D.; Sugarman, Dawn E.; Nich, Charla; Gibbons, Carly J.; Martino, Steve; Rounsaville, Bruce J.; Carroll, Kathleen M.

2013-01-01

Objective Computer-assisted therapies offer a novel, cost-effective strategy for providing evidence-based therapies to a broad range of individuals with psychiatric disorders. However, the extent to which the growing body of randomized trials evaluating computer-assisted therapies meets current standards of methodological rigor for evidence-based interventions is not clear. Method A methodological analysis of randomized clinical trials of computer-assisted therapies for adult psychiatric disorders, published between January 1990 and January 2010, was conducted. Seventy-five studies that examined computer-assisted therapies for a range of axis I disorders were evaluated using a 14-item methodological quality index. Results Results indicated marked heterogeneity in study quality. No study met all 14 basic quality standards, and three met 13 criteria. Consistent weaknesses were noted in evaluation of treatment exposure and adherence, rates of follow-up assessment, and conformity to intention-to-treat principles. Studies utilizing weaker comparison conditions (e.g., wait-list controls) had poorer methodological quality scores and were more likely to report effects favoring the computer-assisted condition. Conclusions While several well-conducted studies have indicated promising results for computer-assisted therapies, this emerging field has not yet achieved a level of methodological quality equivalent to those required for other evidence-based behavioral therapies or pharmacotherapies. Adoption of more consistent standards for methodological quality in this field, with greater attention to potential adverse events, is needed before computer-assisted therapies are widely disseminated or marketed as evidence based. PMID:21536689

Sensitivity and specificity of proposed DSM-5 diagnostic criteria for autism spectrum disorder Running Head: DSM-5 ASD

PubMed Central

McPartland, James C.; Reichow, Brian; Volkmar, Fred R.

2012-01-01

Objective This study evaluated the potential impact of proposed DSM-5 diagnostic criteria for autism spectrum disorder (ASD). Method This study focused on a sample of 977 participants evaluated during the DSM-IV field trial; 657 carried a clinical diagnosis of an ASD, and 276 were diagnosed with a non-autistic disorder. Sensitivity and specificity for proposed DSM-5 diagnostic criteria were evaluated using field trial symptom checklists as follows: (a) individual field trial checklist items (e.g., nonverbal communication), (b) checklist items grouped together as described by a single DSM-5 symptom (e.g., nonverbal and verbal communication), (c) individual DSM-5 criterion (e.g., social-communicative impairment), and (d) overall diagnostic criteria. Results When applying proposed DSM-5 diagnostic criteria for ASD, 60.6% (95% confidence interval: 57–64%) of cases with a clinical diagnosis of an ASD met revised DSM-5 diagnostic criteria for ASD. Overall specificity was high, with 94.9% (95% confidence interval: 92–97%) of individuals accurately excluded from the spectrum. Sensitivity varied by diagnostic subgroup (Autistic Disorder =.76; Asperger’s Disorder = .25; PDD-NOS = .28) and cognitive ability (IQ < 70 = .70; IQ ≥ 70 = .46). Conclusions Proposed DSM-5 criteria substantially alter the composition of the autism spectrum. Revised criteria improve specificity, but exclude a substantial portion of cognitively able individuals and those with ASDs other than Autistic Disorder. A more stringent diagnostic rubric holds significant public health ramifications regarding service eligibility and compatibility of historical and future research. PMID:22449643

Efficacy of killed whole-parasite vaccines in the prevention of leishmaniasis: a meta-analysis.

PubMed

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

2009-07-30

Despite decades of investigation in countries on three continents, an efficacious vaccine against Leishmania infections has not been developed. Although some indication of protection was observed in some of the controlled trials conducted with "first-generation" whole, inactivated Leishmania parasite vaccines, convincing evidence of protection was lacking. After reviewing all previously published or unpublished randomized, controlled field efficacy clinical trials of prophylactic candidate vaccines, a meta-analysis of qualified trials was conducted to evaluate whether there was some evidence of protection revealed by considering the results of all trials together. The findings indicate that the whole-parasite vaccine candidates tested do not confer significant protection against human leishmaniasis.

Intranasal vaccine trial for canine infectious tracheobronchitis (kennel cough).

PubMed

Glickman, L T; Appel, M J

1981-08-01

Two field trials were conducted during periods of endemic (summer) and epizootic (winter) canine infectious tracheobronchitis activity to evaluate the efficacy of three intranasal vaccines in a closed commercial beagle breeding kennel. A trivalent vaccine containing Bordetella bronchiseptica, canine parainfluenza, and canine adenovirus-2 was administered at 3 weeks of age. The vaccine was 71.2% and 81.8% effective in decreasing the incidence of coughing during the winter and summer trials, respectively. The number of deaths was lower in each of the vaccine groups than in the placebo groups. No adverse reactions were observed with any of the intranasal vaccines.

Heart of the Hearth: Making the Popular Clean, Not the Clean Popular - Technology Research, Development, and Tools for Clean Biomass Cookstoves

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gist, Ryan

This technical report summarizes the work completed by BioLite in fulfilment of the US DOE EERE award. The work plan focused on three key objectives: developing an optimized combustion system that demonstrates high combustion efficiency and low PM 2.5 and CO emissions, integrate the system into popular stove phenotypes – side-fed rocket stove architecture like the BioLite HomeStove, and the Patsari chimney stove in Mexico such that they maintain their important phenotypical characteristics, independently evaluate quantitative fuel and emissions performance of the integrated ‘Turbo-Patsari’ in Mexican households. The project activities were organized into six major tasks: A. Develop, fabricate, andmore » test proof-of-concept prototypes B. Develop field prototypes, assess user feedback and field performance C. Define revised stove design for pre-production model, Identify manufacturing requirements and estimated cost to build, Conduct reliability, emissions, and performance testing of pre-production Turbo-Patsari D. Build pre-production Turbo-Patsari stove combustion cores E. Conduct pre-production field trials F. Summarize field trial results and evaluate Turbo-Patsari for potential volume production. A two-pronged approach was adopted for the above tasks. The first involved building a modular test platform that allowed parametric variation of multiple stove design parameters that directly affect its performance – heat output, thermal efficiency, and emissions. The second part of the approach comprised of building a surrogate Patsari based on GIRA’s specifications that could then be modified or retrofitted for optimum performance based on the learnings from the modular test platform. The following sections of the report will describe the findings of tests on these platform, the subsequent development, design, and installation of the Turbo-Patsari, and finally the in-home field trial.« less

First satellite mobile communication trials using BLQS-CDMA

NASA Technical Reports Server (NTRS)

Luzdemateo, Maria; Johns, Simon; Dothey, Michel; Vanhimbeeck, Carl; Deman, Ivan; Wery, Bruno

1993-01-01

In this paper, technical results obtained in the first MSBN Land mobile technical trial are reported. MSBN (Mobile Satellite Business Network) is a new program undertaken by the European Space Agency (ESA) to promote mobile satellite communication in Europe, in particular voice capability. The first phase of the MSBN system implementation plan is an experimental phase. Its purpose is to evaluate through field experiments the performance of the MSBN system prior to finalization of its specifications. Particularly, the objective is to verify in the field and possibly improve the performance of the novel satellite access technique BLQS-CDMA (Band Limited Quasi-Synchronous-Code Division Multiple Access), which is proposed as baseline for the MSBN.

Production and aerial application of wood shreds as a post-fire hillslope erosion mitigation treatment

Treesearch

Peter R. Robichaud; Louise E. Ashmun; Randy B. Foltz; Charles G. Showers; J. Scott Groenier; Jennifer Kesler; Claire DeLeo; Mary Moore

2013-01-01

Guidelines for the production and aerial application of wood shred mulch as a post-fire hillslope treatment were developed from laboratory and field studies, several field operations, and the evaluations of professionals involved in those operations. At two early trial sites, the wood shred mulch was produced off-site and transported to the area of use. At the 2010...

Impact of no-till cover cropping of Italian ryegrass on above and below ground faunal communities inhabiting a soybean field with special emphasis on soybean cyst nematodes

USDA-ARS?s Scientific Manuscript database

Two field trials were conducted in Maryland to evaluate the ability of an Italian ryegrass (IR) (Lolium multiflorum) cover crop in a no-till soybean (Glycine max) planting to 1) reduce populations of plant-parasitic nematodes (i.e., the soybean cyst nematode, Heterodera glycines and lesion nematodes...

Half wavelength dipole antennas over stratified media

NASA Technical Reports Server (NTRS)

Latorraca, G. A.

1972-01-01

Theoretical solutions of the fields induced by half-wavelength, horizontal, electric field dipoles (HEDS) are determined based on studies of infinitesimal, horizontal, electric field dipoles over low loss plane-stratified media. To determine these solutions, an approximation to the current distribution of a half-wavelength HED is derived and experimentally verified. Traverse and antenna measurements obtained on the Athabasca Glacier in the summer of 1971 are related to the characteristics of the transmitting antenna design, and the measurement techniques and field equipment used in the glacier trials are described and evaluated.

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.

Evaluation of the quality of the reporting of phase II clinical trials in oncology: A systematic review.

PubMed

Rivoirard, Romain; Langrand-Escure, Julien; Oriol, Mathieu; Tinquaut, Fabien; Chauvin, Franck; Rancoule, Chloé; Magné, Nicolas; Bourmaud, Aurélie

2018-05-01

To describe the current state of knowledge concerning the quality of reporting in phase II clinical trials in oncology and to describe the various methods published allowing this quality evaluation. databases including MEDLINE and COCHRANE were searched. Reviews and meta-analyses analyzing the quality of the reporting of phase II trials in oncology were included. Descriptive analysis of the results was performed. Thirteen publications were retained. Only 2 publications adopted a systematic approach of evaluation of the quality of reporting by overall scores. The Key Methodological Score (KMS), proposed by Grellety et al., gathering 3 items, seemed adapted for such an evaluation. A score of 3/3 was found in 16.1% of the 156 phase II trials analysed by this score. The other reviews used a qualitative analysis to evaluate the reporting, via an analysis of a single criterion, generally the statistical plan of the study. This item was considered as having been correctly reported in less than 50% of the analysed articles. The quality of reporting in phase II trials in oncology is a field that has been investigated very little (13 publications). When it is studied, the estimated level of quality is not satisfactory, whatever the method employed. The use of an overall score of evaluation is a path which should be pursued, in order to get reliable results. It also seems necessary to propose strong recommendations, which would create a consensus for the methodology and the reporting of these studies. Copyright © 2018 Elsevier B.V. All rights reserved.

Direct, Operational Field Test Evaluation, Human Factors

DOT National Transportation Integrated Search

1998-08-01

IN THIS EXPERIMENT, 32 LICENSED DRIVERS (16 YOUNG, 16 OLD) DROVE ON AN EXPRESSWAY. ON EACH TRIAL (96 PER SUBJECT), 1 TO 3 TRAFFIC MESSAGES CONTAINING 6 TO 14 ITEMS WERE PRESENTED. (L-94 EASTBOUND AT SOUTHFIELD FREEWAY, CONTINUING CONSTRUCTION, RIGHT ...

Sprinkle Treatment experimental project construction and three year evaluation.

DOT National Transportation Integrated Search

1989-06-01

This report documents the construction of a Sprinkle Treatment field trial on a high speed/high volume roadway (55 mph/8520 ADT) and presents the performance data obtained for three years after construction. Normal plant and roadway production rates ...

TSCA Experimental Release Application Approved for Pseudomonas putida Strains (fact sheet)

EPA Pesticide Factsheets

In 1998, EPA approved the TERAs R98-0004/5 submitted by the National Explosives Waste Technology & Evaluation Center (NEWTEC) and the Oak Ridge National Laboratory for field trials of two modified strains of Pseudomonas putida (P.putida).

New treatment directions for IPF: current status of ongoing and upcoming clinical trials.

PubMed

Macagno, Francesco; Varone, Francesco; Leone, Paolo Maria; Mari, Pier-Valerio; Panico, Loredana; Berardini, Ludovica; Richeldi, Luca

2017-07-01

The main objective of this review is to explore the wide and expanding field of new clinical trials in IPF. Recent trials have confirmed the efficacy of the approved drugs pirfenidone and nintedanib; nonetheless, the discovery of new biological pathways has opened new horizons in this field. Areas covered: New strategies against matrix deposition are under study and so is for the role of immunity and autoimmunity. Recent advances in the use of stem cells are opening new possibilities for the recovery of damaged lung tissues. The role of microbioma is under investigation in order to evaluate the use of antibiotics in IPF treatment. Analysing all the new and the upcoming clinical trials, we are trying to offer a comprehensive view of the emerging new frontiers in the treatment of IPF. Expert commentary: The key points for the ongoing and upcoming clinical trials will be to avoid previous mistakes and to choose carefully both study populations and efficacy endpoints. The exciting possibility to enrol patients with progressive lung fibrosis, both idiopathic and not, could be a next step forward. How the existing therapies will fit in a futurist scenario of personalized medicine is still a challenge.

Measurement of Responsibility: A Critical Evaluation of Level of Work Measurement by Time-Span of Discretion.

ERIC Educational Resources Information Center

Laner, S.; And Others

This report is a critical evaluation based on extended field trials and theoretical analysis of the time-span technique of measuring level of work in organizational hierarchies. It is broadly concluded that the technique does possess many of the desirable features claimed by its originator, but that earlier, less highly structured versions based…

Effects of Self-Evaluated Value and Cognition on Leisure Science Engagement

ERIC Educational Resources Information Center

Jack, Brady Michael; She, Hsiao-Ching; Lin, Huann-shyang

2016-01-01

This study uses the Taiwan Programme for International Student Assessment (PISA) 2006 Main Survey and Taiwan PISA 2015 Field Trial survey datasets to investigate how self-evaluated values (i.e. personal and general) and cognitive factors (i.e. self-efficacy and self-concept) of two groups of Taiwanese 15-year-old students separated by 8 years of…

Evaluation of imidacloprid-treated traps as an attract and kill system for filth flies during contingency operations.

USDA-ARS?s Scientific Manuscript database

Field trials were conducted to evaluate if filth fly trap efficacy was increased by application of an insecticide to a trap’s exterior. Four Fly Terminator® Pro traps baited with Fly Terminator® attractant were suspended on PVC pipe framing at a Florida waste transfer site. Exterior surfaces of tw...

First clinical trial of the "MiRo" capsule endoscope by using a novel transmission technology: electric-field propagation.

PubMed

Bang, Seungmin; Park, Jeong Youp; Jeong, Seok; Kim, Young Ho; Shim, Han Bo; Kim, Tae Song; Lee, Don Haeng; Song, Si Young

2009-02-01

We developed a capsule endoscope (CE), "MiRo," with the novel transmission technology of electric-field propagation. The technology uses the human body as a conductive medium for data transmission. Specifications of the prototype include the ability to receive real-time images; size, 10.8 x 24 mm; weight, 3.3 g; field of view, 150 degrees; resolution of power, 320 x 320 pixels; and transmittal speed, 2 frames per second. To evaluate the clinical safety and diagnostic feasibility of the prototype MiRo, we conducted a multicenter clinical trial. All volunteers underwent baseline examinations, including EGD and electrocardiography for the screening of GI obstructive and cardiovascular diseases, before the trial. In the first 10 cases, 24-hour Holter monitoring was also performed. To evaluate the diagnostic feasibility, transmission rate of the captured images, inspection rate of the entire small bowel, and quality of transmitted images (graded as outstanding, excellent, good/average, below average, and poor) were analyzed. Of the 49 healthy volunteers, 45 were included in the trial, and 4 were excluded because of baseline abnormalities. No adverse effects were noted. All CEs were expelled within 2 days, and the entire small bowel could be explored in all cases. The transmission rates of the captured image in the stomach, small bowel, and colon were 99.5%, 99.6%, and 97.2%, respectively. The mean total duration of image transmission was 9 hours, 51 minutes, and the mean transit time of the entire small bowel was 4 hours, 33 minutes. Image quality was graded as good or better in 41 cases (91.1%). Details of the villi and vascular structures of the entire small bowel were clearly visualized in 31 cases (68.9%). MiRo is safe and effective for exploring the entire small bowel, with good image quality and real-time feasibility. This novel transmission technology may have applications beyond the field of capsule endoscopy.

Cassette Referencing System: An Evaluation

ERIC Educational Resources Information Center

Morris, June E.; And Others

1977-01-01

An indexing cassette reference system was developed and subjected to a field trial in which 24 legally blind students from grades 7-12 were taught to use it and then tested on their skill at locating entries in a recorded sample from an encyclopedia. (Author)

Trials of flexible pipe in sour service reveal degradation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Al-Maslamani, M.J.

Field trials on flexible pipe offshore Qatar have shown that, under sour conditions, the layered, composite material can suffer severe degradation leading to failure. The failure demonstrates the significant effects of stress level, environmental aggressiveness, and localized hard zones in promoting sulfide stress cracking. Permeability of the sour gas through the composite layer of the flexible pipe resulted in varying degrees of sulfide attack and hydrogen embrittlement, depending on the susceptibility of the multilayered material. In the trials, the material was used as a gas-lift line in a sour-oil field in the Arabian Gulf. Flexible pipes have been used successfullymore » for transporting methanol, benzene, and gas condensates in wet sweet environments at temperatures of up to 80 C. Little or no information, however, has been available as to its corrosion resistance in sour-service wells containing 6% CO{sub 2} with 3% H{sub 2}S partial pressures and at moderate temperatures. The paper discusses an underwater survey to evaluate the damage, visual inspection, mechanical tests, metallographic exam, and trial results.« less

Field trials to evaluate the effects of transgenic cry1le maize on the community characteristics of arthropod natural enemies

USDA-ARS?s Scientific Manuscript database

Possible non-target effects of transgenic cry1Ie gene maize exerts on natural enemy community biodiversity in the field is unresolved. In the present study, a 2-yr study of transgenic cry1Ie gene maize (Event IE09S034, Bt maize) and its near isoline (Zong 31, non-Bt maize) on natural enemy community...

An evaluation of the completeness of safety reporting in reports of complementary and alternative medicine trials

PubMed Central

2011-01-01

Background Adequate reporting of safety in publications of randomized controlled trials (RCTs) is a pre-requisite for accurate and comprehensive profile evaluation of conventional as well as complementary and alternative medicine (CAM) treatments. Clear and concise information on the definition, frequency, and severity of adverse events (AEs) is necessary for assessing the benefit-harm ratio of any intervention. The objectives of this study are to assess the quality of safety reporting in CAM RCTs; to explore the influence of different trial characteristics on the quality of safety reporting. Methods Survey of safety reporting in RCTs published in 2009 across 15 widely used CAM interventions identified from the Cochrane Collaboration's CAM Field specialized register of trials. Primary outcome measures, the adequacy of reporting of AEs; was defined and categorized according to the CONSORT for harms extension; the percentage of words devoted to the reporting of safety in the entire report and in the results section. Results Two-hundred and five trials were included in the review. Of these, 15% (31/205) reported that no harms were observed during the trial period. Of the remaining 174 trials reporting any safety information, only 21% (36/174) had adequate safety reporting. For all trials, the median percentage of words devoted to the reporting of safety in the results section was 2.6. Moreover, 69% (n = 141) of all trials devoted a lesser or equal percentage of words to safety compared to author affiliations. Of the predictor variables used in regression analysis, multicenter trials had more words devoted to safety in the results section than single centre trials (P = 0.045). Conclusions An evaluation of safety reporting in the reports of CAM RCTs across 15 different CAM interventions demonstrated that the reporting of harms was largely inadequate. The quality of reporting safety information in primary reports of CAM randomized trials requires improvement. PMID:21859470

Pesticide risk assessment in free-ranging bees is weather and landscape dependent.

PubMed

Henry, Mickaël; Bertrand, Colette; Le Féon, Violette; Requier, Fabrice; Odoux, Jean-François; Aupinel, Pierrick; Bretagnolle, Vincent; Decourtye, Axel

2014-07-10

The risk assessment of plant protection products on pollinators is currently based on the evaluation of lethal doses through repeatable lethal toxicity laboratory trials. Recent advances in honeybee toxicology have, however, raised interest on assessing sublethal effects in free-ranging individuals. Here, we show that the sublethal effects of a neonicotinoid pesticide are modified in magnitude by environmental interactions specific to the landscape and time of exposure events. Field sublethal assessment is therefore context dependent and should be addressed in a temporally and spatially explicit way, especially regarding weather and landscape physiognomy. We further develop an analytical Effective Dose (ED) framework to help disentangle context-induced from treatment-induced effects and thus to alleviate uncertainty in field studies. Although the ED framework involves trials at concentrations above the expected field exposure levels, it allows to explicitly delineating the climatic and landscape contexts that should be targeted for in-depth higher tier risk assessment.

First field trial of a transmissible recombinant vaccine against myxomatosis and rabbit hemorrhagic disease.

PubMed

Torres, J M; Sánchez, C; Ramírez, M A; Morales, M; Bárcena, J; Ferrer, J; Espuña, E; Pagès-Manté, A; Sánchez-Vizcaíno, J M

2001-08-14

As a novel approach for immunisation of wild rabbits, we have recently developed a transmissible vaccine against myxomatosis and rabbit hemorrhagic disease (RHD) based on a recombinant myxoma virus (MV) expressing the RHDV capsid protein [J. Virol. 74 (2000) 1114]. The efficacy and safety of the vaccine have been extensively evaluated under laboratory conditions. In this study, we report the first limited field trial of the candidate vaccine that was undertaken in an island of 34 Has containing a population of around 300 rabbits. Following administration by the subcutaneous route to 76 rabbits, the vaccine induced specific antibody responses against both myxomatosis and RHDV in all the inoculated rabbits. Furthermore, the recombinant virus exhibited a limited horizontal transmission capacity, promoting seroconversion of around 50% of the uninoculated rabbit population. No evidence of undesirable effects due to the recombinant virus field release was detected.

Maintaining perceptual constancy while remaining vigilant: left hemisphere change blindness and right hemisphere vigilance.

PubMed

Vos, Leia; Whitman, Douglas

2014-01-01

A considerable literature suggests that the right hemisphere is dominant in vigilance for novel and survival-related stimuli, such as predators, across a wide range of species. In contrast to vigilance for change, change blindness is a failure to detect obvious changes in a visual scene when they are obscured by a disruption in scene presentation. We studied lateralised change detection using a series of scenes with salient changes in either the left or right visual fields. In Study 1 left visual field changes were detected more rapidly than right visual field changes, confirming a right hemisphere advantage for change detection. Increasing stimulus difficulty resulted in greater right visual field detections and left hemisphere detection was more likely when change occurred in the right visual field on a prior trial. In Study 2 an intervening distractor task disrupted the influence of prior trials. Again, faster detection speeds were observed for the left visual field changes with a shift to a right visual field advantage with increasing time-to-detection. This suggests that a right hemisphere role for vigilance, or catching attention, and a left hemisphere role for target evaluation, or maintaining attention, is present at the earliest stage of change detection.

Estimating the Variance of Design Parameters

ERIC Educational Resources Information Center

Hedberg, E. C.; Hedges, L. V.; Kuyper, A. M.

2015-01-01

Randomized experiments are generally considered to provide the strongest basis for causal inferences about cause and effect. Consequently randomized field trials have been increasingly used to evaluate the effects of education interventions, products, and services. Populations of interest in education are often hierarchically structured (such as…

Control of rugose spiraling whitefly using biological insecticides, 2014

USDA-ARS?s Scientific Manuscript database

The objective of this study was to evaluate the efficacy of selected biological insecticides against a new invasive whitefly pest, Aleurodicus rugioperculatus Martin, in white bird of paradise under field condition. The trial was conducted at United States Horticultural Research Laboratory in Fort P...

Online Mathematics Homework Increases Student Achievement

ERIC Educational Resources Information Center

Roschelle, Jeremy; Feng, Mingyu; Murphy, Robert F.; Mason, Craig A.

2016-01-01

In a randomized field trial with 2,850 seventh-grade mathematics students, we evaluated whether an educational technology intervention increased mathematics learning. Assigning homework is common yet sometimes controversial. Building on prior research on formative assessment and adaptive teaching, we predicted that combining an online homework…

Control of Scaphoideus titanus with Natural Products in Organic Vineyards

PubMed Central

Tacoli, Federico; Mori, Nicola; Cargnus, Elena; Da Vià, Sarah; Zandigiacomo, Pietro; Duso, Carlo; Pavan, Francesco

2017-01-01

The leafhopper Scaphoideus titanus is the vector of ‘Candidatus Phytoplasma vitis’, the causal agent of Flavescence dorée (FD) a key disease for European viticulture. In organic vineyards, the control of S. titanus relies mostly on the use of pyrethrins that have suboptimal efficacy. During 2016, three field trials were conducted to evaluate the efficacy of kaolin, orange oil, insecticidal soap and spinosad against S. titanus nymphs, in comparison with pyrethrins. The activity of kaolin was evaluated also in the laboratory. In all field trials, kaolin had an efficacy against nymphs comparable to pyrethrins, while the other products were not effective. Laboratory results confirmed that kaolin increased nymph mortality. In organic vineyards, kaolin and pyrethrins are valuable tools in the management of FD. Nevertheless, their efficacy is lower compared to that of the synthetic insecticides used in conventional viticulture. Therefore, further research should be conducted in order to identify alternatives to synthetic insecticides for S. titanus control in the context of organic viticulture. PMID:29258165

Feasibility, acceptability and clinical utility of the Cultural Formulation Interview: mixed-methods results from the DSM-5 international field trial.

PubMed

Lewis-Fernández, Roberto; Aggarwal, Neil Krishan; Lam, Peter C; Galfalvy, Hanga; Weiss, Mitchell G; Kirmayer, Laurence J; Paralikar, Vasudeo; Deshpande, Smita N; Díaz, Esperanza; Nicasio, Andel V; Boiler, Marit; Alarcón, Renato D; Rohlof, Hans; Groen, Simon; van Dijk, Rob C J; Jadhav, Sushrut; Sarmukaddam, Sanjeev; Ndetei, David; Scalco, Monica Z; Bassiri, Kavoos; Aguilar-Gaxiola, Sergio; Ton, Hendry; Westermeyer, Joseph; Vega-Dienstmaier, Johann M

2017-04-01

Background There is a need for clinical tools to identify cultural issues in diagnostic assessment. Aims To assess the feasibility, acceptability and clinical utility of the DSM-5 Cultural Formulation Interview (CFI) in routine clinical practice. Method Mixed-methods evaluation of field trial data from six countries. The CFI was administered to diagnostically diverse psychiatric out-patients during a diagnostic interview. In post-evaluation sessions, patients and clinicians completed debriefing qualitative interviews and Likert-scale questionnaires. The duration of CFI administration and the full diagnostic session were monitored. Results Mixed-methods data from 318 patients and 75 clinicians found the CFI feasible, acceptable and useful. Clinician feasibility ratings were significantly lower than patient ratings and other clinician-assessed outcomes. After administering one CFI, however, clinician feasibility ratings improved significantly and subsequent interviews required less time. Conclusions The CFI was included in DSM-5 as a feasible, acceptable and useful cultural assessment tool. © The Royal College of Psychiatrists 2017.

Results from a Field Trial of the Radio Frequency Based Cylinder Accountability and Tracking System at the Global Nuclear Fuel Americas Fuel Fabrication Facility

DOE Office of Scientific and Technical Information (OSTI.GOV)

Fitzgerald, Peter; Laughter, Mark D; Martyn, Rose

The Cylinder Accountability and Tracking System (CATS) is a tool designed for use by the International Atomic Energy Agency (IAEA) to improve overall inspector efficiency through real-time unattended monitoring of cylinder movements, site specific rules-based event detection, and the capability to integrate many types of monitoring technologies. The system is based on the tracking of cylinder movements using (radio frequency) RF tags, and the collection of data, such as accountability weights, that can be associated with the cylinders. This presentation will cover the installation and evaluation of the CATS at the Global Nuclear Fuels (GNF) fuel fabrication facility in Wilmington,more » NC. This system was installed to evaluate its safeguards applicability, operational durability under operating conditions, and overall performance. An overview of the system design and elements specific to the GNF deployment will be presented along with lessons learned from the installation process and results from the field trial.« less

Industrial hemp as a potential bioenergy crop in comparison with kenaf, switchgrass and biomass sorghum.

PubMed

Das, Lalitendu; Liu, Enshi; Saeed, Areej; Williams, David W; Hu, Hongqiang; Li, Chenlin; Ray, Allison E; Shi, Jian

2017-11-01

This study takes combined field trial, lab experiment, and economic analysis approaches to evaluate the potential of industrial hemp in comparison with kenaf, switchgrass and biomass sorghum. Agronomy data suggest that the per hectare yield (5437kg) of industrial hemp stem alone was at a similar level with switchgrass and sorghum; while the hemp plants require reduced inputs. Field trial also showed that ∼1230kg/ha hemp grain can be harvested in addition to stems. Results show a predicted ethanol yield of ∼82gallons/dry ton hemp stems, which is comparable to the other three tested feedstocks. A comparative cost analysis indicates that industrial hemp could generate higher per hectare gross profit than the other crops if both hemp grains and biofuels from hemp stem were counted. These combined evaluation results demonstrate that industrial hemp has great potential to become a promising regional commodity crop for producing both biofuels and value-added products. Copyright © 2017 Elsevier Ltd. All rights reserved.

The Impact of Instruction in the WWWDOT Framework on Students' Disposition and Ability to Evaluate Web Sites as Sources of Information

ERIC Educational Resources Information Center

Zhang, Shenglan; Duke, Nell K.

2011-01-01

Much research has demonstrated that students are largely uncritical users of Web sites as sources of information. Research-tested frameworks are needed to increase elementary-age students' awareness of the need and ability to critically evaluate Web sites as sources of information. This study is a randomized field trial of such a framework called…

Why the evidence for outpatient commitment is good enough.

PubMed

Swanson, Jeffrey W; Swartz, Marvin S

2014-06-01

After nearly three decades of studies evaluating the legal practice of involuntary outpatient commitment, there is yet little consensus about its effectiveness and only limited implementation. Debate continues over how best to assist adults with serious mental illnesses who are unable or unwilling to participate in prescribed community treatment and as a result experience repeated involuntary hospitalizations or involvement with the criminal justice system. The authors comment on the Oxford Community Treatment Order Evaluation Trial (OCTET), a recently conducted randomized trial of outpatient commitment, and discuss the limitations of the study's design for resolving the persistent question of whether compulsory treatment is more effective than purely voluntary treatment for this difficult-to-reach target population. The authors conclude that the search for a definitive and generalizable randomized trial of outpatient commitment may be a quixotic quest; the field should, rather, welcome the results of well-conducted, large-scale, quasi-experimental and naturalistic studies with rigorous multivariable statistical controls.

Catch trials in force field learning influence adaptation and consolidation of human motor memory

PubMed Central

Stockinger, Christian; Focke, Anne; Stein, Thorsten

2014-01-01

Force field studies are a common tool to investigate motor adaptation and consolidation. Thereby, subjects usually adapt their reaching movements to force field perturbations induced by a robotic device. In this context, so-called catch trials, in which the disturbing forces are randomly turned off, are commonly used to detect after-effects of motor adaptation. However, catch trials also produce sudden large motor errors that might influence the motor adaptation and the consolidation process. Yet, the detailed influence of catch trials is far from clear. Thus, the aim of this study was to investigate the influence of catch trials on motor adaptation and consolidation in force field experiments. Therefore, 105 subjects adapted their reaching movements to robot-generated force fields. The test groups adapted their reaching movements to a force field A followed by learning a second interfering force field B before retest of A (ABA). The control groups were not exposed to force field B (AA). To examine the influence of diverse catch trial ratios, subjects received catch trials during force field adaptation with a probability of either 0, 10, 20, 30, or 40%, depending on the group. First, the results on motor adaptation revealed significant differences between the diverse catch trial ratio groups. With increasing amount of catch trials, the subjects' motor performance decreased and subjects' ability to accurately predict the force field—and therefore internal model formation—was impaired. Second, our results revealed that adapting with catch trials can influence the following consolidation process as indicated by a partial reduction to interference. Here, the optimal catch trial ratio was 30%. However, detection of consolidation seems to be biased by the applied measure of performance. PMID:24795598

Effects of Hypotensive Anesthesia on Reducing Intraoperative Blood Loss, Duration of Operation, and Quality of Surgical Field During Orthognathic Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

PubMed

Lin, Susie; McKenna, Samuel J; Yao, Chuan-Fong; Chen, Yu-Ray; Chen, Chit

2017-01-01

The objective of this study was to evaluate the efficacy of hypotensive anesthesia in reducing intraoperative blood loss, decreasing operation time, and improving the quality of the surgical field during orthognathic surgery. A systematic review and meta-analysis of randomized controlled trials addressing these issues were carried out. An electronic database search was performed. The risk of bias was evaluated with the Jadad Scale and Delphi List. The inverse variance statistical method and a random-effects model were used. Ten randomized controlled trials were included for analysis. Our meta-analysis indicated that hypotensive anesthesia reduced intraoperative blood loss by a mean of about 169 mL. Hypotensive anesthesia was not shown to reduce the operation time for orthognathic surgery, but it did improve the quality of the surgical field. Subgroup analysis indicated that for blood loss in double-jaw surgery, the weighted mean difference favored the hypotensive group, with a reduction in blood loss of 175 mL, but no statistically significant reduction in blood loss was found for anterior maxillary osteotomy. If local anesthesia with epinephrine was used in conjunction with hypotensive anesthesia, the reduction in intraoperative blood loss was increased to 254.93 mL. Hypotensive anesthesia was effective in reducing blood loss and improving the quality of the surgical field, but it did not reduce the operation time for orthognathic surgery. The use of local anesthesia in conjunction with hypotensive general anesthesia further reduced the amount of intraoperative blood loss for orthognathic surgery. Copyright © 2016 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

First attempts to obtain a reference drift curve for traditional olive grove's plantations following ISO 22866.

PubMed

Gil, Emilio; Llorens, Jordi; Gallart, Montserrat; Gil-Ribes, Jesús A; Miranda-Fuentes, Antonio

2018-06-15

The current standard for the field measurements of spray drift (ISO 22866) is the only official standard for drift measurements in field conditions for all type of crops, including bushes and trees. A series of field trials following all the requirements established in the standard were arranged in a traditional olive grove in Córdoba (south of Spain). The aims of the study were to evaluate the applicability of the current standard procedure to the particular conditions of traditional olive trees plantations, to evaluate the critical requirements for performing the tests and to obtain a specific drift curve for such as important and specific crop as olive trees in traditional plantations, considering the enormous area covered by this type of crop all around the world. Results showed that the field trials incur a very complex process due to the particular conditions of the crop and the very precise environmental requirements. Furthermore, the trials offered a very low level of repeatability as the drift values varied significantly from one spray application to the next, with the obtained results being closely related to the wind speed, even when considering the standard minimum value of 1 m·s -1 . The collector's placement with respect to the position of the isolated trees was determined as being critical since this substantially modifies the ground deposit in the first 5 m. Even though, a new drift curve for olive trees in traditional plantation has been defined, giving an interesting tool for regulatory aspects. Conclusions indicated that a deep review of the official standard is needed to allow its application to the most relevant orchard/fruit crops. Copyright © 2018 Elsevier B.V. All rights reserved.

[Economic analysis of multinational clinical trials in oncology].

PubMed

Lejeune, Catherine; Lueza, Béranger; Bonastre, Julia

2018-02-01

In oncology, as in other fields of medicine, international multicentre clinical trials came into being so as to include a sufficient number of subjects to investigate a clinical situation. The existence of tight budgetary constraints and the desire to make the best use of the resources available have resulted in the development of economic evaluations associated with these trials, which, thanks to their level of evidence and their size, provide particularly relevant material. Nonetheless, economic evaluations alongside international clinical trials raise specific questions of methodology with regard to both the design and the analysis of the results. Indeed, the costs of goods and services consumed, the types and quantities of resources, and medical practices vary from one country to another and within an individual country. Economic data from the different countries involved must be available so as to study and to take into account this variability, and appropriate techniques for cost estimations and analysis must be implemented to aggregate the results from several countries. From a review of the literature, the aim of this work was to provide an overview of the specific methodological features of economic evaluations alongside international clinical trials: analysis of efficacy data from several countries, collection of resources and real costs, methods to establish the monetary value of resources, methods to aggregate results accounting for the trial effect. Copyright © 2017 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.

Motivational Interviewing and Medication Review in Coronary Heart Disease (MIMeRiC): Intervention Development and Protocol for the Process Evaluation.

PubMed

Östbring, Malin Johansson; Eriksson, Tommy; Petersson, Göran; Hellström, Lina

2018-01-30

Trials of complex interventions are often criticized for being difficult to interpret because the effects of apparently similar interventions vary across studies dependent on context, targeted groups, and the delivery of the intervention. The Motivational Interviewing and Medication Review in Coronary heart disease (MIMeRiC) trial is a randomized controlled trial (RCT) of an intervention aimed at improving pharmacological secondary prevention. Guidelines for the development and evaluation of complex interventions have recently highlighted the need for better reporting of the development of interventions, including descriptions of how the intervention is assumed to work, how this theory informed the process evaluation, and how the process evaluation relates to the outcome evaluation. This paper aims to describe how the intervention was designed and developed. The aim of the process evaluation is to better understand how and why the intervention in the MIMeRiC trial was effective or not effective. The research questions for evaluating the process are based on the conceptual model of change processes assumed in the intervention and will be analyzed by qualitative and quantitative methods. Quantitative data are used to evaluate the medication review in terms of drug-related problems, to describe how patients' beliefs about medicines are affected by the intervention, and to evaluate the quality of motivational interviewing. Qualitative data will be used to analyze whether patients experienced the intervention as intended, how cardiologists experienced the collaboration and intervention, and how the intervention affected patients' overall experience of care after coronary heart disease. The development and piloting of the intervention are described in relation to the theoretical framework. Data for the process evaluation will be collected until March 2018. Some process evaluation questions will be analyzed before, and others will be analyzed after the outcomes of the MIMeRiC RCT are known. This paper describes the framework for the design of the intervention tested in the MIMeRiC trial, development of the intervention from the pilot stage to the complete trial intervention, and the framework and methods for the process evaluation. Providing the protocol of the process evaluation allows prespecification of the processes that will be evaluated, because we hypothesize that they will determine the outcomes of the MIMeRiC trial. This protocol also constitutes a contribution to the new field of process evaluations as made explicit in health services research and clinical trials of complex interventions. ©Malin Johansson Östbring, Tommy Eriksson, Göran Petersson, Lina Hellström. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 30.01.2018.

Exploring the transparency mechanism and evaluating the effect of public reporting on prescription: a protocol for a cluster randomized controlled trial.

PubMed

Du, Xin; Wang, Dan; Wang, Xuan; Yang, Shiru; Zhang, Xinping

2015-03-21

The public reporting of health outcomes has become one of the most popular topics and is accepted as a quality improvement method in the healthcare field. However, little research has been conducted on the transparency mechanism, and results are mixed with regard to the evaluation of the effect of public reporting on quality improvement. The objectives of this trial are to investigate the transparency mechanism and to evaluate the effect of public reporting on prescription at the level of individual participants. This study involves a cluster randomized controlled trial conducted in 20 primary-care facilities (clusters). Eligible clusters are those facilities with excellent hospital information systems and that have agreed to participate in the trial. The 20 clusters are matched into 10 pairs according to Technique for Order Preference by Similarity to Ideal Solution score. As the unit of randomization, each pair of facilities is assigned at random to a control or an intervention group through coin flipping. Prescribed ranking information is publicly reported in the intervention group. The public materials include the posters of individuals and of facilities, the ranking lists of general practitioners, and brochures of patients, which are updated monthly. The intervention began on 13th November 2013 and lasted for one year. Specifically, participants are surveyed at five points in time (baseline, quarterly following the intervention) through questionnaires, interviews, and observations. These participants include an average of 600 patients, 300 general practitioners, 15 directors, and 6 health bureau administrators. The primary outcomes are the transparency mechanism model and the changes in medicine-prescribe. Subsequently, the modifications in the transparency mechanism constructs are evaluated. The outcomes are measured at the individual participant level, and the professional who analyzes the data is blind to the randomization status. This study protocol outlines a design that aims to examine the transparency mechanism and to evaluate the effect of public reporting on prescription. The research design is significant in the field of public policy. Furthermore, this study intends to fill the gap of the investigation of the transparency mechanism and the evaluation of public reporting on prescription.

Enhanced Recovery After Surgery (ERAS®) in Individuals with Diabetes: A Systematic Review.

PubMed

Albalawi, Zaina; Laffin, Michael; Gramlich, Leah; Senior, Peter; McAlister, Finlay A

2017-08-01

Prevalence of diabetes in surgical patients is 10-40%. It is well recognized that they have higher rates of complications, and longer stays in hospital compared to patients without diabetes. Enhanced recovery after surgery (ERAS) is an evidence-based multimodal surgical care pathway that improves postoperative complications and length of stay in patients without diabetes. This review evaluates the evidence on whether individuals with diabetes would benefit from ERAS implementation. MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL) and EMBASE searched with no language restrictions applied. Conference proceedings and bibliographies were reviewed. Experts in the field were contacted, and www.clinicaltrials.gov searched for ongoing trials. Randomized controlled trials (RCT) looking at individuals with diabetes undergoing surgery randomized to ERAS ® or conventional care. Non-randomized controlled trials, controlled before-after studies, interrupted time series, and cohort studies with concurrent controls were also considered. Two authors independently screened studies. The electronic search yielded 437 references. After removing duplicates, 376 were screened for eligibility. Conference proceedings and bibliographies identified additional references. Searching www.clinicaltrials.gov yielded 59 references. Contacting experts in the field identified no further studies. Fourteen full articles were assessed and subsequently excluded for the following reasons: used an intervention other than ERAS ® , did not include patients with diabetes, or used an uncontrolled observational design. To date, the effects of ERAS ® on patients with diabetes have not been rigorously evaluated. This review highlights the lack of evidence in this area and provides guidance on design for future studies.

Mass balance and swath displacement evaluations from agricultural application field trials

USDA-ARS?s Scientific Manuscript database

Spray drift is on an ongoing concern for any agricultural application and continues to be the focus for new developments and research efforts dealing with drift reduction technologies, best management application practices and the development of new decision support systems for applicators. Typical...

Relationship between NDVI at early bloom and yield in germplasm evaluation trials

USDA-ARS?s Scientific Manuscript database

The use of high-throughput phenotyping (HTP) equipment is expanding as it offers the potential to increase the efficiency of making selections in cotton (Gossypium hirsutum L.) improvement programs. Measurements often being collected on HTP field equipment include normalized difference vegetative in...

Statistical Techniques to Analyze Pesticide Data Program Food Residue Observations.

PubMed

Szarka, Arpad Z; Hayworth, Carol G; Ramanarayanan, Tharacad S; Joseph, Robert S I

2018-06-26

The U.S. EPA conducts dietary-risk assessments to ensure that levels of pesticides on food in the U.S. food supply are safe. Often these assessments utilize conservative residue estimates, maximum residue levels (MRLs), and a high-end estimate derived from registrant-generated field-trial data sets. A more realistic estimate of consumers' pesticide exposure from food may be obtained by utilizing residues from food-monitoring programs, such as the Pesticide Data Program (PDP) of the U.S. Department of Agriculture. A substantial portion of food-residue concentrations in PDP monitoring programs are below the limits of detection (left-censored), which makes the comparison of regulatory-field-trial and PDP residue levels difficult. In this paper, we present a novel adaption of established statistical techniques, the Kaplan-Meier estimator (K-M), the robust regression on ordered statistic (ROS), and the maximum-likelihood estimator (MLE), to quantify the pesticide-residue concentrations in the presence of heavily censored data sets. The examined statistical approaches include the most commonly used parametric and nonparametric methods for handling left-censored data that have been used in the fields of medical and environmental sciences. This work presents a case study in which data of thiamethoxam residue on bell pepper generated from registrant field trials were compared with PDP-monitoring residue values. The results from the statistical techniques were evaluated and compared with commonly used simple substitution methods for the determination of summary statistics. It was found that the maximum-likelihood estimator (MLE) is the most appropriate statistical method to analyze this residue data set. Using the MLE technique, the data analyses showed that the median and mean PDP bell pepper residue levels were approximately 19 and 7 times lower, respectively, than the corresponding statistics of the field-trial residues.

Immunisation against East Coast fever by the infection and treatment method: evaluation of the use of ice baths for field delivery and appraisal of an acid formulation of long-acting tetracycline.

PubMed

Marcotty, T; Billiouw, M; Chaka, G; Berkvens, D; Losson, B; Brandt, J

2001-08-20

Immunisation by the infection and treatment method using the Katete strain is currently the most efficient prophylactic technique to control East Coast fever (ECF) in the endemic areas of the Eastern Province of Zambia. The maintenance of the cold chain in liquid nitrogen up to the time of inoculation and the cost of the reference long-acting oxytetracycline (Terramycin LA, Pfizer) are the main drawbacks of the method. The work presented in this paper aims at reducing the cost of immunisation against ECF by using an ice bath for the field delivery and a cheaper long-acting oxytetracycline formulation as chemotherapeutic agent. In experimental conditions, the results from 40 calves immunised after various periods of storage on ice ranging from 4 to 32 h indicate that deferred immunisation performed with a stabilate kept on ice for up to 6h after thawing has an efficiency of 90%. Moreover, sporozoites kept on ice were still surviving 32 h after thawing. In a field trial, 91 calves were inoculated with a stabilate kept for 3.5-5.5 h after thawing and dilution whereas 86 calves were immunised using the standard method. Clinical and parasitological reactions to immunisation were monitored as well as the seroconversion. In the field trial, the deferred immunisation was more efficient than the standard method. The acid formulation of oxytetracycline that was tested was found as suitable as the reference alkaline formulation for the chemotherapeutic control of the Katete strain in ECF immunisation. One indoor trial was carried out on 10 animals and a field trial involved 93 calves.

Applied Technology on Influence of Humic Substances on Fertilizer, Water-use Efficiency and Soil Health

NASA Astrophysics Data System (ADS)

Seyedbagheri, Mir

2017-04-01

In continuation of over 35 years of on-farm studies on soil organic matter from different humates (functional carbon) and compost, I have documented quantitative improvements in soil health and water-use efficiency. The ability of soil organic matter to bind water has become an important theme for research in past years. Research trials were established to evaluate the efficacy of different commercial functional carbon products derived from Leonardite (highly oxidized lignite) in crop production. In each of these trials, functional carbon (Humic and Fulvic acids) products were used in a randomized complete block design. The use of humic substances creates strong organo-mineral complexes (aggregation), chelation, as well as enhanced buffering capacities. We evaluated data from 3 fields and compared the results. Our observation and field demonstrations indicated there was a marked increase in water retention. Data from humic acid (HA) trials showed that different cropping systems responded differently to different products in relation to yield and quality. The functional carbon products used in the study seemed to enhance fertilizer and water-use efficiency by increasing complexation, chelation and buffering. The consistent use of good quality functional carbons in our replicated plots resulted in a yield increase from 6% to 30% over several decades.

An evaluation of an intelligent home monitoring system.

PubMed

Sixsmith, A J

2000-01-01

A trial was performed of an intelligent monitoring system which used sensors in the home to identify emergencies by detecting deviations from normal activity patterns. The field trial lasted three months. Twenty-two elderly people agreed to participate. Their ages ranged from early 60s to over 85, with two-thirds in the age range 75-84 years. They lived in four different localities within the UK--Ipswich, Northumberland, Merseyside and Nottingham. A total of 61 alerts was recorded, at a mean frequency about one alert per month per client. Of the 61 alerts generated, 46 were classified as false alerts and the other 15 as genuine, although no real emergencies occurred during the study. Many people in the field trial reported enhanced feelings of safety and security, which could help to stimulate independence and help them to remain living in their own homes. The monitoring system increased the care choices available to elderly people and supported and enhanced the carer's role.

Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis: An Expert Statement.

PubMed

Ruiz, Carlos E; Hahn, Rebecca T; Berrebi, Alain; Borer, Jeffrey S; Cutlip, Donald E; Fontana, Greg; Gerosa, Gino; Ibrahim, Reda; Jelnin, Vladimir; Jilaihawi, Hasan; Jolicoeur, E Marc; Kliger, Chad; Kronzon, Itzhak; Leipsic, Jonathon; Maisano, Francesco; Millan, Xavier; Nataf, Patrick; O'Gara, Patrick T; Pibarot, Philippe; Ramee, Stephen R; Rihal, Charanjit S; Rodes-Cabau, Josep; Sorajja, Paul; Suri, Rakesh; Swain, Julie A; Turi, Zoltan G; Tuzcu, E Murat; Weissman, Neil J; Zamorano, Jose L; Serruys, Patrick W; Leon, Martin B

2017-04-25

The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization exists for circumferentially sutured surgical valve paravalvular leak (PVL) closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices. The PVL Academic Research Consortium met to review evidence and make recommendations for assessment of disease severity, data collection, and updated endpoint definitions. A 5-class grading scheme to evaluate PVL was developed in concordance with VARC recommendations. Unresolved issues in the field are outlined. The current PVL Academic Research Consortium provides recommendations for assessment of disease severity, data collection, and endpoint definitions. Future research in the field is warranted. Copyright © 2017 American College of Cardiology Foundation and European Society of Cardiology. Published by Elsevier Inc. All rights reserved.

EVALUATION OF TYPHOID VACCINES IN THE LABORATORY AND IN A CONTROLLED FIELD TRIAL IN POLAND. PRELIMINARY REPORT.

PubMed

BLAKE, J B

1965-01-01

In 1961 a controlled field trial of anti-typhoid vaccines was carried out in 25 regions in Poland. Four types of vaccine were studied: (1) bacterial acetone-killed and -dried vaccine (two kinds), (2) bacterial formol-killed phenol-preserved vaccine, (3) Westphal's endotoxin adsorbed on aluminium hydroxide, and (4) Grasset's vaccine (autolysate of typhoid bacilli adsorbed on aluminium hydroxide). The control vaccine was tetanus toxoid. A total of 690 655 persons received two inoculations. Prior to the field trial, laboratory tests were carried out on the vaccines, postvaccinal reactions were studied, and a serological examination was made of randomly selected blood samples. The vaccination was followed by a two-year survey of cases of typhoid and other diseases. Among children aged 5-14 years, the formol-killed phenol-preserved vaccine was found to be the most effective and Grasset's vaccine the least. Among adults aged 15-60 years, no conclusive evidence for the effectiveness of the vaccines could be obtained owing to the small number of cases. This may be due to the maintenance of immunity through repeated annual vaccination with bacterial vaccines.

Application methods of infrared thermal images in the health care field of traditional Chinese medicine

NASA Astrophysics Data System (ADS)

Li, Ziru; Zhang, Xusheng

2008-12-01

Infrared thermal imaging (ITI) is the potential imaging technique for the health care field of traditional Chinese medicine (TCM). Successful application demands obeying the characteristics and regularity of the ITI of human body and designing rigorous trials. First, the influence of time must be taken into account as the ITI of human body varies with time markedly. Second, relative magnitude is preferred to be the index of the image features. Third, scatter diagrams and the method of least square could present important information for evaluating the health care effect. A double-blind placebo-controlled randomized trial was undertaken to study the influences of Shengsheng capsule, one of the TCM health food with immunity adjustment function, on the ITI of human body. The results showed that the effect of Shengsheng capsule to people with weak constitution or in the period of being weak could be reflected objectively by ITI. The relative efficacy rate was 81.3% for the trial group and 30.0% for the control group, there was significant difference between the two groups (P=0.003). So the sensitivity and objectivity of ITI are of great importance to the health care field of TCM.

Cognitive Rehabilitation: ACTION Training for Soldiers with Executive Dysfunction

DTIC Science & Technology

2015-10-01

failing to comply with a collection of information if it does not display a currently valid OMB control number. PLEASE DO NOT RETURN YOUR FORM TO... controlled trial. Aim 1: Finalize ACTION curriculum/ manuals; field test Aim 2: Evaluate ACTION instructional methods (the extent to which SM with...metacognitive strategy instruction (MSI), together called Target Acquisition Practices ( Group 1) by evaluating the extent to which training 1) improves

[Realization of design regarding experimental research in the clinical real-world research].

PubMed

He, Q; Shi, J P

2018-04-10

Real world study (RWS), a further verification and supplement for explanatory randomized controlled trial to evaluate the effectiveness of intervention measures in real clinical environment, has increasingly become the focus in the field of research on medical and health care services. However, some people mistakenly equate real world study with observational research, and argue that intervention and randomization cannot be carried out in real world study. In fact, both observational and experimental design are the basic designs in real world study, while the latter usually refers to pragmatic randomized controlled trial and registry-based randomized controlled trial. Other nonrandomized controlled and adaptive designs can also be adopted in the RWS.

Technological Advances in the Treatment of Cancer: Combining Modalities to Optimize Outcomes.

PubMed

Wong, Eric T; Toms, Steven A; Ahluwalia, Manmeet S

2015-11-01

The anticancer treatment modality tumor treating fields (TTFields; Optune, Novocure) use the lower frequency range of the electromagnetic spectrum to destroy tumor cells during mitosis. This treatment has been evaluated in several trials of patients with glioblastoma. In these patients, TTFields are delivered through 4 transducer arrays applied to the scalp. In a phase 3 clinical trial of patients with recurrent glioblastoma, TTFields were as effective as chemotherapy, and were associated with fewer and milder systemic toxicities. Data from a phase 3 trial in newly diagnosed glioblastoma suggested that the addition of TTFields to postoperative radiation therapy and chemotherapy represents an important advance in the management of newly diagnosed glioblastoma. Ongoing clinical trials are investigating the efficacy and safety of TTFields in other tumor types, including pancreatic cancer, mesothelioma, ovarian cancer, and non–small cell lung cancer. Other recent advances in the management of cancer have been seen with immunomodulatory therapy, including immune checkpoint inhibitors. Further study will be necessary to evaluate whether TTFields will enhance or impair other established and newly emerging therapies.

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...

Therapeutic chemical treatment of grape vines for root diseases

USDA-ARS?s Scientific Manuscript database

There is a need to develop post-plant treatment of soil pests for perennial vine and tree crops. Field trials were performed to evaluate post-plant treatment of established grape vines (Vitis vinifera var. Thompson Seedless) with known problems of soilborne plant-parasitic nematodes and pathogens us...

An Interaction-Based Approach to Enhancing Secondary School Instruction and Student Achievement

ERIC Educational Resources Information Center

Allen, Joseph; Pianta, Robert; Gregory, Anne; Mikami, Amori; Lun, Janetta

2011-01-01

Improving teaching quality is widely recognized as critical to addressing deficiencies in secondary school education, yet the field has struggled to identify rigorously evaluated teacher-development approaches that can produce reliable gains in student achievement. A randomized controlled trial of My Teaching Partner-Secondary--a Web-mediated…

Screening almond rootstocks for sources of resistance to Armillaria root diesease

USDA-ARS?s Scientific Manuscript database

Prunus is one of the most susceptible horticultural crops to Armillaria root disease. Resistance to the geographically isolated causal fungi Armillaria mellea and A. tabescens has been evaluated in separate field trials of almond and other Prunus rootstocks, but not in one comprehensive study. We ev...

Methodological Foundations for the Empirical Evaluation of Non-Experimental Methods in Field Settings

ERIC Educational Resources Information Center

Wong, Vivian C.; Steiner, Peter M.

2015-01-01

Across the disciplines of economics, political science, public policy, and now, education, the randomized controlled trial (RCT) is the preferred methodology for establishing causal inference about program impacts. But randomized experiments are not always feasible because of ethical, political, and/or practical considerations, so non-experimental…

Determination of selection criteria for spray drift reduction from atomization data

USDA-ARS?s Scientific Manuscript database

When testing and evaluating drift reduction technologies (DRT), there are different metrics that can be used to determine if the technology reduces drift as compared to a reference system. These metrics can include reduction in percent of fine drops, measured spray drift from a field trial, or comp...

Effects of Midas® on Nematodes in Commercial Floriculture Production in Florida

USDA-ARS?s Scientific Manuscript database

Cut flower producers currently have limited options for nematode control. Four field trials were conducted in 2006 and 2007 to evaluate Midas® (iodomethane:chloropicrin 50:50) for control of root-knot nematodes (Meloidogyne arenaria) on Celosia argentea var. cristata in a commercial floriculture pr...

Onion and weed response to mustard (Sinapis alba) seed meal

USDA-ARS?s Scientific Manuscript database

Weed control in organic onion production is often difficult and expensive, requiring numerous cultivations and extensive hand-weeding. Onion safety and weed control with mustard seed meal (MSM) derived from Sinapis alba was evaluated in greenhouse and field trials. MSM applied at 110, 220, and 440 g...

Evaluation of a mobile steam applicator for soil disinfestation in California strawberry

USDA-ARS?s Scientific Manuscript database

Steam-disinfestation of soil as an alternative to chemical fumigation was investigated in both research and commercial strawberry production field trials at four sites over two years (2011-2013) using new prototype commercial application equipment: a tractor-drawn device that physically mixed the st...

Native range assessment of classical biological control agents: impact of inundative releases as pre-introduction evaluation.

PubMed

Jenner, W H; Mason, P G; Cappuccino, N; Kuhlmann, U

2010-08-01

Diadromus pulchellus Wesmael (Hymenoptera: Ichneumonidae) is a pupal parasitoid under consideration for introduction into Canada for the control of the invasive leek moth, Acrolepiopsis assectella (Zeller) (Lepidoptera: Acrolepiidae). Since study of the parasitoid outside of quarantine was not permitted in Canada at the time of this project, we assessed its efficacy via field trials in its native range in central Europe. This was done by simulating introductory releases that would eventually take place in Canada when a permit for release is obtained. In 2007 and 2008, experimental leek plots were artificially infested with pest larvae to mimic the higher pest densities common in Canada. Based on a preliminary experiment showing that leek moth pupae were suitable for parasitism up to 5-6 days after pupation, D. pulchellus adults were mass-released into the field plots when the first host cocoons were observed. The laboratory-reared agents reproduced successfully in all trials and radically reduced leek moth survival. Taking into account background parasitism caused by naturally occurring D. pulchellus, the released agents parasitized at least 15.8%, 43.9%, 48.1% and 58.8% of the available hosts in the four release trials. When this significant contribution to leek moth mortality is added to previously published life tables, in which pupal parasitism was absent, the total pupal mortality increases from 60.1% to 76.7%. This study demonstrates how field trials involving environmental manipulation in an agent's native range can yield predictions of the agent's field efficacy once introduced into a novel area.

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. © 2016 John Wiley & Sons Ltd.

Genetic progress in oat associated with fungicide use in Rio Grande do Sul, Brazil.

PubMed

Follmann, D N; Cargnelutti Filho, A; Lúcio, A D; de Souza, V Q; Caraffa, M; Wartha, C A

2016-12-19

The State of Rio Grande do Sul (RS) is the largest producer of oat in Brazil with the aid of consolidated breeding programs, which are constantly releasing new cultivars. The main objectives of this study were to: 1) evaluate the annual genetic progress in grain yield and hectoliter weight of the oat cultivars in RS, with and without fungicide use on aerial parts of plants; and 2) evaluate the efficiency of oat breeding programs in introducing disease-resistant genes in the released cultivars through network yield trials conducted with and without fungicide use on aerial plant parts. The data on grain yield and hectoliter weight were obtained from 89 competition field trials of oat cultivars carried out from 2007 to 2014 in nine municipalities of RS. Of the total 89 trials, 44 were carried out with fungicide application on aerial plant parts and 45 were carried out without fungicide application. The annual genetic progress in oat cultivars was studied using the methodology proposed by Vencovsky (1988). The annual genetic progress in oat grain yield was 1.02% with fungicide use and 4.02% without fungicide use during the eight-year study period in RS. The annual genetic progress with respect to the hectoliter weight was 0.08% for trials with fungicide use and 0.71% for trials without fungicide use. Performing network yield trials with and without fungicide use on the aerial plants parts is a feasible method to evaluate the efficiency of oat breeding programs in introducing disease-resistant genes in the released cultivars.

Quantifying Data Quality for Clinical Trials Using Electronic Data Capture

PubMed Central

Nahm, Meredith L.; Pieper, Carl F.; Cunningham, Maureen M.

2008-01-01

Background Historically, only partial assessments of data quality have been performed in clinical trials, for which the most common method of measuring database error rates has been to compare the case report form (CRF) to database entries and count discrepancies. Importantly, errors arising from medical record abstraction and transcription are rarely evaluated as part of such quality assessments. Electronic Data Capture (EDC) technology has had a further impact, as paper CRFs typically leveraged for quality measurement are not used in EDC processes. Methods and Principal Findings The National Institute on Drug Abuse Treatment Clinical Trials Network has developed, implemented, and evaluated methodology for holistically assessing data quality on EDC trials. We characterize the average source-to-database error rate (14.3 errors per 10,000 fields) for the first year of use of the new evaluation method. This error rate was significantly lower than the average of published error rates for source-to-database audits, and was similar to CRF-to-database error rates reported in the published literature. We attribute this largely to an absence of medical record abstraction on the trials we examined, and to an outpatient setting characterized by less acute patient conditions. Conclusions Historically, medical record abstraction is the most significant source of error by an order of magnitude, and should be measured and managed during the course of clinical trials. Source-to-database error rates are highly dependent on the amount of structured data collection in the clinical setting and on the complexity of the medical record, dependencies that should be considered when developing data quality benchmarks. PMID:18725958

Role of massage therapy on reduction of neonatal hyperbilirubinemia in term and preterm neonates: a review of clinical trials.

PubMed

Garg, Bhawan Deep; Kabra, Nandkishor S; Balasubramanian, Haribalakrishna

2017-09-13

Neonatal hyperbilirubinemia (NNH) is one of the leading causes of admissions in nursery throughout the world. It affects approximately 2.4-15% of neonates during the first 2 weeks of life. To evaluate the role of massage therapy for reduction of NNH in both term and preterm neonates. The literature search was done for various randomized control trials (RCTs) by searching the Cochrane Library, PubMed, and EMBASE. This review included total of 10 RCTs (two in preterm neonates and eight in term neonates) that fulfilled inclusion criteria. In most of the trials, Field massage was given. Six out of eight trials reported reduction in bilirubin levels in term neonates. However, only one trial (out of two) reported significant reduction in bilirubin levels in preterm neonates. Both trials in preterm neonates and most of the trials in term neonates (five trials) reported increased stool frequencies. Role of massage therapy in the management of NNH is supported by the current evidence. However, due to limitations of the trials, current evidences are not sufficient to use massage therapy for the management of NNH in routine practice.

Introduction to the Special Issue.

ERIC Educational Resources Information Center

Petrosino, Anthony

2003-01-01

Introduces the articles of this special issue focusing on randomized field trials in criminology. In spite of the overall lack of randomized field trials in criminology, some agencies and individuals are able to mount an impressive number of field trials, and these articles focus on their experiences. (SLD)

Evaluation of the leucine incorporation technique for detection of pollution-induced community tolerance to copper in a long-term agricultural field trial with urban waste fertilizers.

PubMed

Lekfeldt, Jonas Duus Stevens; Magid, Jakob; Holm, Peter E; Nybroe, Ole; Brandt, Kristian Koefoed

2014-11-01

Copper (Cu) is known to accumulate in agricultural soils receiving urban waste products as fertilizers. We here report the use of the leucine incorporation technique to determine pollution-induced community tolerance (Leu-PICT) to Cu in a long-term agricultural field trial. A significantly increased bacterial community tolerance to Cu was observed for soils amended with organic waste fertilizers and was positively correlated with total soil Cu. However, metal speciation and whole-cell bacterial biosensor analysis demonstrated that the observed PICT responses could be explained entirely by Cu speciation and bioavailability artifacts during Leu-PICT detection. Hence, the agricultural application of urban wastes (sewage sludge or composted municipal waste) simulating more than 100 years of use did not result in sufficient accumulation of Cu to select for Cu resistance. Our findings also have implications for previously published PICT field studies and demonstrate that stringent PICT detection criteria are needed for field identification of specific toxicants. Copyright © 2014 Elsevier Ltd. All rights reserved.

Defining, Designing, Implementing, and Evaluating Phase 4 HIV Prevention Effectiveness Trials for Vulnerable Populations

PubMed Central

Kelly, Jeffrey A.; Spielberg, Freya; McAuliffe, Timothy L.

2008-01-01

Summary The efficacy of behavioral HIV prevention interventions has been convincingly demonstrated in a large number of randomized controlled phase 3 research outcome trials. Little research attention has been directed toward studying the effectiveness of the same interventions when delivered by providers to their own clients or community members, however. This article argues for the need to conduct phase 4 effectiveness trials of HIV prevention interventions that have been found efficacious in the research arena. Such trials can provide important information concerning the impact of interventions when applied in heterogeneous “real-world” circumstances. This article raises design issues and methodologic questions that need to be addressed in the conduct of phase 4 trials of behavioral interventions. These issues include the selection and training of service providers engaged in such trials, maintenance of fidelity to intervention protocol in provider-delivered interventions, determination of intervention core elements versus aspects that require tailoring, selection of relevant phase 4 study outcomes, interpretation of findings indicative of field effectiveness, sustainability, and other aspects of phase 4 trial design. PMID:18301131

Laboratory trials of three anticoagulant rodenticides for use against the Indian field mouse, Mus booduga Gray.

PubMed Central

Balasubramanyam, M.; Christopher, M. J.; Purushotham, K. R.

1984-01-01

The efficacy of three anticoagulant rodenticides for use against the Indian field mouse, Mus booduga, was evaluated in the laboratory. The poisons, namely warfarin, bromadiolone and brodifacoum, were all found to be toxic enough at the concentrations normally used against other commensal and field rodents. With brodifacoum (0.001 25%), bromadiolone (0.005%) and warfarin (0.025%), 83% of the animals died respectively after 1, 1 and 6 days' feeding. It is suggested that brodifacoum and bromadiolone might be more economical than warfarin for use in practical rodent control. PMID:6512257

Evaluation of early efficacy endpoints for proof-of-concept trials.

PubMed

Chen, Cong; Sun, Linda; Li, Chih-Lin

2013-03-11

A Phase II proof-of-concept (POC) trial usually uses an early efficacy endpoint other than a clinical endpoint as the primary endpoint. Because of the advancement in bioscience and technology, which has yielded a number of new surrogate biomarkers, drug developers often have more candidate endpoints to choose from than they can handle. As a result, selection of endpoint and its effect size as well as choice of type I/II error rates are often at the center of heated debates in design of POC trials. While optimization of the trade-off between benefit and cost is the implicit objective in such a decision-making process, it is seldom explicitly accounted for in practice. In this research note, motivated by real examples from the oncology field, we provide practical measures for evaluation of early efficacy endpoints (E4) for POC trials. We further provide optimal design strategies for POC trials that include optimal Go-No Go decision criteria for initiation of Phase III and optimal resource allocation strategies for conducting multiple POC trials in a portfolio under fixed resources. Although oncology is used for illustration purpose, the same idea developed in this research note also applies to similar situations in other therapeutic areas or in early-stage drug development in that a Go-No Go decision has to rely on limited data from an early efficacy endpoint and cost-effectiveness is the main concern.

Combined Sprays of Sex Pheromone and Insecticides to Attract and Kill Codling Moth

USDA-ARS?s Scientific Manuscript database

Field trials were conducted to evaluate the potential of an "attract-and-kill" approach for control of codling moth by adding half-rates of microencapsulated (MEC) lambda-cyhalothrin or acetamiprid to a sex pheromone formulation in Turkey and the USA in 2006. Two apple orchards were divided into six...

Abscisic acid form, concentration, and application timing influence phenology and bud cold hardiness in Merlot grapevines

USDA-ARS?s Scientific Manuscript database

The effects of abscisic acid (ABA) form, concentration and application timing on bud cold hardiness, phenology and fruiting performance on ‘Merlot’ grapevines (Vitis vinifera) were evaluated in a three year field trial with site locations in British Columbia Canada, Ontario Canada, Washington U.S. ...

Evaluation of production method and formulation for optimizing in-vitro produced Gypchek

Treesearch

R. E. Webb; G. B. White; K. W. Thorpe; J. M. Slavicek; J. D. Podgwaite; R. W. Fuester; P. B. Taylor; R. A. Peiffer; M. A. Valenti

2003-01-01

Gypchek (USDA Forest Service, Washington, DC), a product with the Lymantria dispar multi-enveloped nucleopolyhedrovirus (LdMNPV) as the active ingredient, is a general use biopesticide for use against the gypsy moth. Successful field trials with Gypchek incorporated with the commercially-produced Carrier 038 (Valent BioSciences Corp., Libertyville,...

Field Trials of a Canadian Biomass Feller Buncher

Treesearch

Douglas J. Frederick; Bryce J. Stokes; Dennis T. Curtin

1986-01-01

A prototype, continuous felling and bunching machine was evaluated in harvesting a three-year-old sycamore short-rotation energy plantation in Alabuma. Prediction equations, production rates, and costs were developed for the harvester.Production of the feller buncher was approximately 850 stems per hour (17.3 green tonnes). Estimated total cost of the machine...

The water quality and quantity effects of biofuel operations in pine plantations of the southeastern USA

Treesearch

J. Nettles; M. Youssef; J. Cacho; J. Grace; Z. Leggett; E. Sucre

2011-01-01

Working alongside operational trials, a comprehensive research programme was developed to evaluate sustainability, life-cycle analysis, soil productivity, wildlife, and water resource impacts. The hydrology field studies consist of three sets of forested watersheds, each with mid-rotation pine reference, switchgrass (Panicum virgatum) interplanted, typical...

Influence of preplant applications of 2,4-D, dicamba, tribenuron, and tribenuron plus thifensulfuron on peanut

USDA-ARS?s Scientific Manuscript database

Field trials were conducted in Georgia, North Carolina, and Texas to evaluate the effects of preplant applications of 2,4-D, dicamba, tribenuron, and tribenuron plus thifensulfuron on peanut yield. Herbicides were applied 30, 15, 7, or 0 days before planting (DBP) in conventional production systems ...

Using experimental design and spatial analyses to improve the precision of NDVI estimates in upland cotton field trials

USDA-ARS?s Scientific Manuscript database

Controlling for spatial variability is important in high-throughput phenotyping studies that enable large numbers of genotypes to be evaluated across time and space. In the current study, we compared the efficacy of different experimental designs and spatial models in the analysis of canopy spectral...

A Randomized Trial of a Science, Technology, Engineering, and Mathematics Mentoring Program

ERIC Educational Resources Information Center

Sowers, Jo-Ann; Powers, Laurie; Schmidt, Jessica; Keller, Thomas E.; Turner, Alison; Salazar, Amy; Swank, Paul R.

2017-01-01

Individuals with disabilities are underrepresented in science, technology, engineering, and math (STEM) fields. The purpose of this study was to experimentally evaluate the impact of a STEM mentor intervention and differences between students matched with mentors with or without disabilities on career planning outcomes. An independent groups ×…

Evaluation of several types of curing and protective materials for concrete : final report on part I : laboratory and outdoor exposure studies preliminary to field trials.

DOT National Transportation Integrated Search

1970-01-01

Concern for improving the durability of concrete has focused renewed attention on all aspects of concrete technology. Numerous proprietary products which are claimed to improve durability have been marketed as protective coatings, curing agents or co...

Evaluation of steam and soil solarization for Meloidogyne arenaria control in Florida floriculture crops

USDA-ARS?s Scientific Manuscript database

Steam and soil solarization were investigated for control of the root-knot nematode Meloidogyne arenaria in two years of field trials on a commercial flower farm in Florida. The objective was to determine if pre-plant steam treatments in combination with solarization, or solarization alone effective...

Evaluation of steam for Meloidogyne Arenaria control in production of in-ground floriculture crops in Florida

USDA-ARS?s Scientific Manuscript database

Steam and soil solarization were investigated for control of the root-knot nematode Meloidogyne arenaria in two years of field trials on a commercial flower farm in Florida. The objective was to determine if pre-plant steam treatments in combination with solarization, or solarization alone effective...

Semi field trials to evaluate undersowings in maize for management of western corn rootworm larvae

USDA-ARS?s Scientific Manuscript database

Western corn rootworm larvae (Diabrotica virgifera virgifera) need to feed on maize roots after hatching from overwintering eggs. It was hypothesized that the roots of undersown plants mixed with maize roots disrupt the host finding of the larvae, lowering their survival and subsequently reducing la...

A reanalysis of cluster randomized trials showed interrupted time-series studies were valuable in health system evaluation.

PubMed

Fretheim, Atle; Zhang, Fang; Ross-Degnan, Dennis; Oxman, Andrew D; Cheyne, Helen; Foy, Robbie; Goodacre, Steve; Herrin, Jeph; Kerse, Ngaire; McKinlay, R James; Wright, Adam; Soumerai, Stephen B

2015-03-01

There is often substantial uncertainty about the impacts of health system and policy interventions. Despite that, randomized controlled trials (RCTs) are uncommon in this field, partly because experiments can be difficult to carry out. An alternative method for impact evaluation is the interrupted time-series (ITS) design. Little is known, however, about how results from the two methods compare. Our aim was to explore whether ITS studies yield results that differ from those of randomized trials. We conducted single-arm ITS analyses (segmented regression) based on data from the intervention arm of cluster randomized trials (C-RCTs), that is, discarding control arm data. Secondarily, we included the control group data in the analyses, by subtracting control group data points from intervention group data points, thereby constructing a time series representing the difference between the intervention and control groups. We compared the results from the single-arm and controlled ITS analyses with results based on conventional aggregated analyses of trial data. The findings were largely concordant, yielding effect estimates with overlapping 95% confidence intervals (CI) across different analytical methods. However, our analyses revealed the importance of a concurrent control group and of taking baseline and follow-up trends into account in the analysis of C-RCTs. The ITS design is valuable for evaluation of health systems interventions, both when RCTs are not feasible and in the analysis and interpretation of data from C-RCTs. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Systematic review and economic evaluation of Helicobacter pylori eradication treatment for non-ulcer dyspepsia

PubMed Central

Moayyedi, Paul; Soo, Shelly; Deeks, Jonathan; Forman, David; Mason, James; Innes, Michael; Delaney, Brendan

2000-01-01

Objectives To evaluate efficacy and cost effectiveness of Helicobacter pylori eradication treatment in patients with non-ulcer dyspepsia infected with H pylori. Design Systematic review of randomised controlled trials comparing H pylori eradication with placebo or another drug treatment. Results were incorporated into a Markov model comparing health service costs and benefits of H pylori eradication with antacid treatment over one year. Data sources Six electronic databases were searched for randomised controlled trials from January 1966 to May 2000. Experts in the field, pharmaceutical companies, and journals were contacted for information on any unpublished trials. Trial reports were reviewed according to predefined eligibility and quality criteria. Main outcome measures Relative risk reduction for remaining dyspeptic symptoms (the same or worse) at 3-12 months. Cost per dyspepsia-free month estimated from Markov model based on estimated relative risk reduction. Results Twelve trials were included in the systematic review, nine of which evaluated dyspepsia at 3-12 months in 2541 patients. H pylori eradication treatment was significantly superior to placebo in treating non-ulcer dyspepsia (relative risk reduction 9% (95% confidence interval 4% to 14%)), one case of dyspepsia being cured for every 15 people treated. H pylori eradication cost £56 per dyspepsia-free month during first year after treatment. Conclusion H pylori eradication may be cost effective treatment for non-ulcer dyspepsia in infected patients but further evidence is needed on decision makers' willingness to pay for relief of dyspepsia. PMID:10987767

Field testing of the experimental wood preservative N'N-naphtaloylhydroxylamine : five and eight years results

Treesearch

Frederick Green; Rachel A. Arango; Stan T. Lebow

2010-01-01

Field trials were designed to evaluate the ability of the experimental wood preservative N’N-naphthaloylhydroxylamine (NHA) to inhibit fungal decay and termite damage at the USDA Harrison Experimental Forest (HEF) in Saucier, MS. Twenty replicate 19 x 19 x 457 mm (0.75 x 0.75 x 18 in.) southern yellow pine stakes and 10 replicate 19 x 19 x 76 mm (0.75 x 0.75 x 3 in.)...

A critical appraisal of the reporting quality of published randomized controlled trials in the fall injuries.

PubMed

Asghari Jafarabadi, Mohammad; Sadeghi-Bazrgani, Homayoun; Dianat, Iman

2018-06-01

To evaluate the quality of reporting in published randomized controlled trials (RTCs) in the field of fall injuries. The 188 RTCs published between 2001 and 2011, indexed in EMBASE and Medline databases were extracted through searching by appropriate keywords and EMTree classification terms. The evaluation trustworthiness was assured through parallel evaluations of two experts in epidemiology and biostatistics. About 40%-75% of papers had problems in reporting random allocation method, allocation concealment, random allocation implementation, blinding and similarity among groups, intention to treat and balancing benefits and harms. Moreover, at least 10% of papers inappropriately/not reported the design, protocol violations, sample size justification, subgroup/adjusted analyses, presenting flow diagram, drop outs, recruitment time, baseline data, suitable effect size on outcome, ancillary analyses, limitations and generalizability. Considering the shortcomings found and due to the importance of the RCTs for fall injury prevention programmes, their reporting quality should be improved.

Evaluation of two counterflow traps for testing behaviour-mediating compounds for the malaria vector Anopheles gambiae s.s. under semi-field conditions in Tanzania

PubMed Central

Schmied, Wolfgang H; Takken, Willem; Killeen, Gerry F; Knols, Bart GJ; Smallegange, Renate C

2008-01-01

Background Evaluation of mosquito responses towards different trap-bait combinations in field trials is a time-consuming process that can be shortened by experiments in contained semi-field systems. Possible use of the BG Sentinel (BGS) trap to sample Anopheles gambiae s.s. was evaluated. The efficiency of this trap was compared with that of the Mosquito Magnet-X (MM-X) trap, when baited with foot odour alone or combinations of foot odour with carbon dioxide (CO2) or lemongrass as behaviour-modifying cues. Methods Female An. gambiae s.s. were released in an experimental flight arena that was placed in a semi-field system and left overnight. Catch rates for the MM-X and BGS traps were recorded. Data were analysed by fitting a generalized linear model to the (n+1) transformed catches. Results Both types of traps successfully captured mosquitoes with all odour cues used. When the BGS trap was tested against the MM-X trap in a choice assay with foot odour as bait, the BGS trap caught about three times as many mosquitoes as the MM-X trap (P = 0.002). Adding CO2 (500 ml/min) to foot odour increased the number of mosquitoes caught by 268% for the MM-X (P < 0.001) and 34% (P = 0.051) for the BGS trap, compared to foot odour alone. When lemongrass leaves were added to foot odour, mosquito catches were reduced by 39% (BGS, P < 0.001) and 38% (MM-X, P = 0.353), respectively. Conclusion The BGS trap shows high potential for field trials due to its simple construction and high catch rate when baited with human foot odour only. However, for rapid screening of different baits in a contained semi-field system, the superior discriminatory power of the MM-X trap is advantageous. PMID:18980669

Efficacy of a film-forming medical device containing sunscreen (50+) and piroxicam 0.8% in actinic keratosis and field cancerization: a multicenter, assessor-blinded, 3 month trial.

PubMed

Puviani, Mario; Galloni, Chiara; Marchetti, Silvia; Sergio Pavone, Paolo; Lovati, Silvia; Pistone, Giuseppe; Caputo, Valentina; Tilotta, Giovanna; Scarcella, Giuseppe; Campione, Elena; Diluvio, Laura; Garofalo, Virginia; Bianchi, Luca; Milani, Massimo

2017-07-01

Sunscreen protection in subjects with actinic keratosis (AK) is highly recommended to prevent clinical evolution of this in situ skin cancer condition. Use of topical anti-cyclooxygenase drugs such as diclofenac and piroxicam reduces the number of lesions and improves the cancerization field. A film-forming medical device in a cream formulation containing organic and inorganic sun-filters (50+ SPF) and piroxicam 0.8% (ACTX) has shown in a pilot, single-center, open trial to reduce AK lesions improving the cancerization field. We evaluated in a multicenter, assessor-blinded, 3 month trial the efficacy of ACTX in AK. A total of 70 subjects with at least three AK lesions on the scalp or face were enrolled after written informed consent. Primary outcomes of the study were the clinical evolution of number of AK lesions on a target zone area and the evolution of dermoscopy features of the target lesion, assessing erythema, scaling, pigmentation, and follicular plug, using a 5 point score (from 0 to 4; maximum score: 16). Lesion count and dermoscopy score were evaluated in a blind fashion assessing digital color high definition coded images. A secondary outcome was the Investigator Global Score (IGS) of clinical evolution of the target area using a 7 point scale from -2 (significantly worse) to +4 (completely cured). IGS was evaluated in an open fashion. Subjects were instructed to apply the cream twice daily on the target area, using one finger-tip unit for the treatment of a 35 cm 2 area. All but one subject (40 men and 30 women, mean age 73 years) concluded the study period. At baseline the mean (±SD) number of AK lesions in the target area were 7.0 (5.9) with a median value of 5 and the dermoscopy score of the target lesion was 7.0 (2.3) with a median value of 7.0. ACTX treatment reduced AK lesions to 3.2 (2.9), (p = .0001; Wilcoxon Test), representing a 55% relative reduction. Dermoscopy score was reduced to 3.3 (2.6) (p = .0001) (a reduction of 53%). The IGS after ACTX treatment was +1.9 (1.1), with a median of 2.0. A total of 86% of subjects showed a clinical improvement of IGS (≥1) with a very significant/complete clearance (score +3 or +4) in 42% subjects. No change or a worsening of AK lesions was observed in 14% of the subjects. The product was well tolerated. No serious adverse events were reported during the duration of the trial. In this multicenter, assessor-blinded trial, the use of a film-forming medical device with sun protection and anti-inflammatory actions was effective in reducing AK lesions and improving the dermoscopy aspect of the target lesion in 86% of treated subjects. A head-to-head trial evaluating the efficacy of this medical device in comparison with diclofenac is warranted to establish whether this therapeutic approach could offer additional advantages in term of AK lesion reduction compared to an established topical treatment. (Trial ID: ISRCTN72020277).

Industry Bias in Randomized Controlled Trials in General and Abdominal Surgery: An Empirical Study.

PubMed

Probst, Pascal; Knebel, Phillip; Grummich, Kathrin; Tenckhoff, Solveig; Ulrich, Alexis; Büchler, Markus W; Diener, Markus K

2016-07-01

Industry sponsorship has been identified as a source of bias in several fields of medical science. To date, the influence of industry sponsorship in the field of general and abdominal surgery has not been evaluated. A systematic literature search (1985-2014) was performed in the Cochrane Library, MEDLINE, and EMBASE to identify randomized controlled trials in general and abdominal surgery. Information on funding source, outcome, and methodological quality was extracted. Association of industry sponsorship and positive outcome was expressed as odds ratio (OR) with 95% confidence interval (CI). A χ test and a multivariate logistic regression analysis with study characteristics and known sources of bias were performed. A total of 7934 articles were screened and 165 randomized controlled trials were included. No difference in methodological quality was found. Industry-funded trials more often presented statistically significant results for the primary endpoint (OR, 2.44; CI, 1.04-5.71; P = 0.04). Eighty-eight of 115 (76.5%) industry-funded trials and 19 of 50 (38.0%) non-industry-funded trials reported a positive outcome (OR, 5.32; CI, 2.60-10.88; P < 0.001). Industry-funded trials more often reported a positive outcome without statistical justification (OR, 5.79; CI, 2.13-15.68; P < 0.001). In a multivariate analysis, funding source remained significantly associated with reporting of positive outcome (P < 0.001). Industry funding of surgical trials leads to exaggerated positive reporting of outcomes. This study emphasizes the necessity for declaration of funding source. Industry involvement in surgical research has to ensure scientific integrity and independence and has to be based on full transparency.

[Effect of cellular immune supportive treatment on immunity of esophageal carcinoma patients after modern two-field lymph node dissection].

PubMed

Wang, Jun-Ye; Ma, Guo-Wei; Dai, Shu-Qin; Rong, Tie-Hua; Wang, Xin; Lin, Peng; Ye, Wen-Feng; Zhang, Lan-Jun; Li, Xiao-Dong; Zhang, Xu; Yao, Guang-Yu

2007-07-01

Cellular immunity suppression is marked in patients with esophageal carcinoma, which may be resulted temporarily from surgical injury. This study was to evaluate the effect of cellular immune supportive treatment on cellular immunity of patients with esophageal carcinoma. A total of 60 patients with thoracic esophageal carcinoma, received two-field dissection, were randomized into control group and trial (immune supportive treatment) group. The patients in trial group were injected with Shenqi injection after operation; the patients in control group received no immune supportive treatment. Peripheral blood samples were obtained before operation, and 3 and 9 days after operation. AgNOR (argyrophilic nucleolar organizer regions) activity in peripheral blood T lymphocytes was measured by tumor immune microphotometry. T cell subsets were measured by flow cytometry. The proportions of CD3+CD4+ and CD4+/CD8+ cells were significantly higher in trial group than in control group at 3 days after operation (P < 0.05). The amount of AgNOR and proportions of CD3+, CD3+CD4+, CD4+/CD8+, and CD4+CD25+ cells were significantly higher in trial group than in control group at 9 days after operation (P < 0.05). There was no significant difference in 1-year survival rate between the 2 groups (P > 0.05). Shenqi injection could obviously improve cellular immunity of the esophageal carcinoma patients after modern two-field dissection.

DSM-III field trials: II. Initial experience with the multiaxial system.

PubMed

Spitzer, R L; Forman, J B

1979-06-01

The multiaxial system of DSM-III includes nondiagnostic data that are valuable in understanding possible etiological factors and in treatment planning and prognosis. The authors describe the reliability of axis IV--severity of psychosocial stressors--and axis V--highest level of adaptive functioning in the past year--for 281 adult patients interviewed in phase one of the DSM-III field trials. The kappa coefficient of agreement for axis IV was .62 for joint interviews and .58 for separate interviews, which the authors consider at least fair. Reliability for axis V was quite good, .80 for joint interviews and .69 for separate interviews. Eighty-one percent of the participating clinicians judged the multiaxial system to be a useful addition to traditional diagnostic evaluation, although many indicated that they had difficulty quantifying severity of psychosocial stressors.

Respiratory alkalosis and primary hypocapnia in Labrador Retrievers participating in field trials in high-ambient-temperature conditions.

PubMed

Steiss, Janet E; Wright, James C

2008-10-01

To determine whether Labrador Retrievers participating in field trials develop respiratory alkalosis and hypocapnia primarily in conditions of high ambient temperatures. 16 Labrador Retrievers. At each of 5 field trials, 5 to 10 dogs were monitored during a test (retrieval of birds over a variable distance on land [1,076 to 2,200 m]; 36 assessments); ambient temperatures ranged from 2.2 degrees to 29.4 degrees C. For each dog, rectal temperature was measured and a venous blood sample was collected in a heparinized syringe within 5 minutes of test completion. Blood samples were analyzed on site for Hct; pH; sodium, potassium, ionized calcium, glucose, lactate, bicarbonate, and total CO2 concentrations; and values of PvO2 and PvCO2. Scatterplots of each variable versus ambient temperature were reviewed. Regression analysis was used to evaluate the effect of ambient temperature (< or = 21 degrees C and > 21 degrees C) on each variable. Compared with findings at ambient temperatures < or = 21 degrees C, venous blood pH was increased (mean, 7.521 vs 7.349) and PvCO2 was decreased (mean, 17.8 vs 29.3 mm Hg) at temperatures > 21 degrees C; rectal temperature did not differ. Two dogs developed signs of heat stress in 1 test at an ambient temperature of 29 degrees C; their rectal temperatures were higher and PvCO2 values were lower than findings in other dogs. When running distances frequently encountered at field trials, healthy Labrador Retrievers developed hyperthermia regardless of ambient temperature. Dogs developed respiratory alkalosis and hypocapnia at ambient temperatures > 21 degrees C.

Host Preference of Megacopta cribraria (Hemiptera: Plataspidae) on Selected Edible Beans and Soybean.

PubMed

Blount, J L; Buntin, G D; Sparks, A N

2015-06-01

Megacopta cribraria (F.) (Hemiptera: Plataspidae) is an Old World pest of legumes in Asia. Since its 2009 discovery in Georgia, it has become an economic pest of soybeans in the southeastern United States. The objective of this study was to determine the host preference of M. cribraria on edible legumes that might incur economic damage from injury of this pest. From 2012 to 2013 choice, no-choice, and field trials were conducted to evaluate the host suitability of several beans of commercial interest including pinto bean, lima bean, winter pea, and black-eyed pea. Choice and no-choice studies were conducted under greenhouse conditions. Plants in greenhouse trials were infested with adults and egg masses collected from kudzu and soybean and monitored for ∼2 wk. Field trials were allowed to be infested by naturally occurring M. cribraria populations. Sweep and whole plant counts of adults, egg masses, and nymphs were used to quantify field infestations. The legume crops found to be suitable developmental hosts are soybean, edamame, and pigeon pea. Low levels of development were seen on fava bean and none on the remaining entries. © The Authors 2015. Published by Oxford University Press on behalf of Entomological Society of America. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Guide to designing, conducting, publishing and communicating results of clinical studies involving probiotic applications in human participants

PubMed Central

Cabana, Michael D; Vidry, Stéphane; Merenstein, Dan; Hummelen, Ruben; Ellis, Collin L; Heimbach, James T; Hempel, Susanne; Lynch, Susan V; Sanders, Mary Ellen; Tancredi, Daniel J

2010-01-01

The heterogeneity of human clinical trials to assess the effectiveness of probiotics presents challenges regarding interpretation and comparison. Evidence obtained from clinical trials among a population with a disease or specific risk factors may not be generalizable to healthy individuals. The evaluation of interventions in healthy persons requires careful selection of outcomes due to the absence of health indicators and the low incidence of preventable conditions. Given the tremendous resources invested in such trials, development of consistent approaches to assessing the effectiveness of probiotics would be beneficial. Furthermore, the reporting, presentation and communication of results may also affect the validity of the scientific evidence obtained from a trial. This review outlines the challenges associated with the design, implementation, data analysis and interpretation of clinical trials in humans involving probiotics. Best practices related to their design are offered along with recommendations for enhanced collaboration to advance research in this emerging field. PMID:21327031

Building Successful Relationships in the PLCO Cancer Screening Trial

PubMed Central

Marcus, Pamela M.; Broski, Karen G.; Buys, Saundra S.; Childs, Jeffery; Church, Timothy R.; Gohagan, John K.; Gren, Lisa H.; Higgins, Darlene; Jaggi, Rachel; Jenkins, Victoria; Johnson, Christine C.; Lappe, Karen; O’Brien, Barbara; Ogden, Sheryl L.; Prorok, Philip C.; Reding, Douglas; Shambaugh, Vicki; Yokochi, Lance A.; Yurgalevitch, Susan

2017-01-01

Biomedical research cannot succeed without funding, knowledgeable staff, and appropriate infrastructure. There are however equally important but intangible factors that are rarely considered in planning large multidisciplinary endeavors or evaluating their success. The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial required extensive collaborations between individuals from many fields, including clinicians, clinical trialists, and administrators; it also addressed questions across the spectrum of cancer prevention and control, In this manuscript, we examine the experiences and opinions of trial staff regarding the building of successful relationships in PLCO. We summarize, in narrative form, data collected using open-ended questionnaires that were administered to the National Cancer Institute project officers, coordinating center staff, screening center principal investigators, and screening center coordinators in 2015, about 3 years after publication of the final primary trial manuscript. Trust, respect, listening to others, and in-person interaction were frequently mentioned as crucial to building successful relationships. PMID:26238208

Commentary: Randomized controlled trials in autism spectrum disorder: state of the field and challenges for the future.

PubMed

Simonoff, Emily

2018-04-01

This issue of the Journal includes two articles summarizing the evidence from clinical trials aimed at improving symptoms of autism. French and Kennedy (Journal of Child Psychology and Psychiatry, 2018, xx, xxxx) systematically review randomized controlled trials (RCTs) aimed at an "early intervention" and focus on trials including children with or at risk of autism under age 6 years. Although no type of intervention were excluded from their review, none of the included 48 RCTs employed pharmacological modalities and the overwhelming majority tested psychological/behavioural interventions aimed at modifying aspects of observed behaviours that are abnormal in children with autism. Using the standard Cochrane tool for evaluating risk of bias, French and Kennedy conclude that many RCTs are of low quality, which throws into question the reliance that should be placed on the findings. © 2018 Association for Child and Adolescent Mental Health.

A multi-level intervention in worksites to increase fruit and vegetable access and intake: Rationale, design and methods of the 'Good to Go' cluster randomized trial.

PubMed

Risica, Patricia M; Gorham, Gemma; Dionne, Laura; Nardi, William; Ng, Doug; Middler, Reese; Mello, Jennifer; Akpolat, Rahmet; Gettens, Katelyn; Gans, Kim M

2018-02-01

Fruit and vegetable (F&V) consumption is an important contributor to chronic disease prevention. However, most Americans do not eat adequate amounts. The worksite is an advantageous setting to reach large, diverse segments of the population with interventions to increase F&V intake, but research gaps exist. No studies have evaluated the implementation of mobile F&V markets at worksites nor compared the effectiveness of such markets with or without nutrition education. This paper describes the protocol for Good to Go (GTG), a cluster randomized trial to evaluate F&V intake change in employees from worksites randomized into three experimental arms: discount, fresh F&V markets (Access Only arm); markets plus educational components including campaigns, cooking demonstrations, videos, newsletters, and a web site (Access Plus arm); and an attention placebo comparison intervention on physical activity and stress reduction (Comparison). Secondary aims include: 1) Process evaluation to determine costs, reach, fidelity, and dose as well as the relationship of these variables with changes in F&V intake; 2) Applying a mediating variable framework to examine relationships of psychosocial factors/determinants with changes in F&V consumption; and 3) Cost effectiveness analysis of the different intervention arms. The GTG study will fill important research gaps in the field by implementing a rigorous cluster randomized trial to evaluate the efficacy of an innovative environmental intervention providing access and availability to F&V at the worksite and whether this access intervention is further enhanced by accompanying educational interventions. GTG will provide an important contribution to public health research and practice. Trial registration number NCT02729675, ClinicalTrials.gov. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

A multi-level intervention in worksites to increase fruit and vegetable access and intake: Rationale, design and methods of the ‘Good to Go’ cluster randomized trial

PubMed Central

Risica, Patricia M.; Gorham, Gemma; Dionne, Laura; Nardi, William; Ng, Doug; Middler, Reese; Mello, Jennifer; Akpolat, Rahmet; Gettens, Katelyn; Gans, Kim M.

2018-01-01

Background Fruit and vegetable (F&V) consumption is an important contributor to chronic disease prevention. However, most Americans do not eat adequate amounts. The worksite is an advantageous setting to reach large, diverse segments of the population with interventions to increase F&V intake, but research gaps exist. No studies have evaluated the implementation of mobile F&V markets at worksites nor compared the effectiveness of such markets with or without nutrition education. Methods This paper describes the protocol for Good to Go (GTG), a cluster randomized trial to evaluate F&V intake change in employees from worksites randomized into three experimental arms: discount, fresh F&V markets (Access Only arm); markets plus educational components including campaigns, cooking demonstrations, videos, newsletters, and a web site (Access Plus arm); and an attention placebo comparison intervention on physical activity and stress reduction (Comparison). Secondary aims include: 1) Process evaluation to determine costs, reach, fidelity, and dose as well as the relationship of these variables with changes in F&V intake; 2) Applying a mediating variable framework to examine relationships of psychosocial factors/determinants with changes in F&V consumption; and 3) Cost effectiveness analysis of the different intervention arms. Discussion The GTG study will fill important research gaps in the field by implementing a rigorous cluster randomized trial to evaluate the efficacy of an innovative environmental intervention providing access and availability to F&V at the worksite and whether this access intervention is further enhanced by accompanying educational interventions. GTG will provide an important contribution to public health research and practice. Trial registration number NCT02729675, ClinicalTrials.gov PMID:29242108

Methodological issues in evaluating cost effectiveness of adjuvant aromatase inhibitors in early breast cancer: a need for improved modelling to aid decision making.

PubMed

Annemans, Lieven

2008-01-01

The optimal adjuvant hormonal strategy in post-menopausal women with early breast cancer is a subject of ongoing debate. Aromatase inhibitors (AIs) have been successfully evaluated in clinical trials that have compared them with a standard treatment of 5 years of tamoxifen. However, several options are available in terms of treatment schedule and selected drug. Systematic reviews of clinical trials and health economic evaluations attempt to contribute to the debate. The objective of this paper is to provide a critical review of existing health economic evaluations with a focus on those parameters and assumptions with the largest impact on final outcomes.A wide range of different inputs and assumptions exist, which make a comparison of results difficult, if not impossible. In particular, the modelling of recurrence rates over longer time horizons than those observed in clinical trials, a cornerstone of health economic modelling, is subject to quite different approaches. The practice of indirect comparison of different AIs without sufficiently acknowledging population differences is also bothersome. A list of key features (related to time horizon, clinical data input, patient subtypes, budget impact and model calibration) that an ideal model should have in order to better assist decision makers in this field is proposed.

Evaluation of pulsing magnetic field effects on paresthesia in multiple sclerosis patients, a randomized, double-blind, parallel-group clinical trial.

PubMed

Afshari, Daryoush; Moradian, Nasrin; Khalili, Majid; Razazian, Nazanin; Bostani, Arash; Hoseini, Jamal; Moradian, Mohamad; Ghiasian, Masoud

2016-10-01

Evidence is mounting that magnet therapy could alleviate the symptoms of multiple sclerosis (MS). This study was performed to test the effects of the pulsing magnetic fields on the paresthesia in MS patients. This study has been conducted as a randomized, double-blind, parallel-group clinical trial during the April 2012 to October 2013. The subjects were selected among patients referred to MS clinic of Imam Reza Hospital; affiliated to Kermanshah University of Medical Sciences, Iran. Sixty three patients with MS were included in the study and randomly were divided into two groups, 35 patients were exposed to a magnetic pulsing field of 4mT intensity and 15-Hz frequency sinusoidal wave for 20min per session 2 times per week over a period of 2 months involving 16 sessions and 28 patients was exposed to a magnetically inactive field (placebo) for 20min per session 2 times per week over a period of 2 months involving 16 sessions. The severity of paresthesia was measured by the numerical rating scale (NRS) at 30, 60days. The study primary end point was NRS change between baseline and 60days. The secondary outcome was NRS change between baseline and 30days. Patients exposing to magnetic field showed significant paresthesia improvement compared with the group of patients exposing to placebo. According to our results pulsed magnetic therapy could alleviate paresthesia in MS patients .But trials with more patients and longer duration are mandatory to describe long-term effects. Copyright © 2016 Elsevier B.V. All rights reserved.

Performance evaluation of ALCAN-AASF50-ferric coated activated alumina and granular ferric hydroxide (GFH) for arsenic removal in the presence of competitive ions in an active well :Kirtland field trial - initial studies.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Neidel, Linnah L.; Krumhansl, James Lee; Siegel, Malcolm Dean

This report documents a field trial program carried out at Well No.15 located at Kirtland Air Force Base, Albuquerque, New Mexico, to evaluate the performance of two relatively new arsenic removal media, ALCAN-AASF50 (ferric coated activated alumina) and granular ferric hydroxide (US Filter-GFH). The field trial program showed that both media were able to remove arsenate and meet the new total arsenic maximum contaminant level (MCL) in drinking water of 10 {micro}g/L. The arsenate removal capacity was defined at a breakthrough effluent concentration of 5 {micro}g/L arsenic (50% of the arsenic MCL of 10 {micro}g/L). At an influent pH ofmore » 8.1 {+-} 0.4, the arsenate removal capacity of AASF50 was 33.5 mg As(V)/L of dry media (29.9 {micro}g As(V)/g of media on a dry basis). At an influent pH of 7.2 {+-} 0.3, the arsenate removal capacity of GFH was 155 mg As(V)/L of wet media (286 {micro}g As(V)/g of media on a dry basis). Silicate, fluoride, and bicarbonate ions are removed by ALCAN AASF50. Chloride, nitrate, and sulfate ions were not removed by AASF50. The GFH media also removed silicate and bicarbonate ions; however, it did not remove fluoride, chloride, nitrate, and sulfate ions. Differences in the media performance partly reflect the variations in the feed-water pH between the 2 tests. Both the exhausted AASF50 and GFH media passed the Toxicity Characteristic Leaching Procedure (TCLP) test with respect to arsenic and therefore could be disposed as nonhazardous waste.« less

Heterotic patterns in rapeseed (Brassica napus L.): I. Crosses between spring and Chinese semi-winter lines.

PubMed

Qian, W; Sass, O; Meng, J; Li, M; Frauen, M; Jung, C

2007-06-01

Chinese semi-winter rapeseed is genetically diverse from Canadian and European spring rapeseed. This study was conducted to evaluate the potential of semi-winter rapeseed for spring rapeseed hybrid breeding, to assess the genetic effects involved, and to estimate the correlation of parental genetic distance (GD) with hybrid performance, heterosis, general combining ability (GCA) and specific combining ability (SCA) in crosses between spring and semi-winter rapeseed lines. Four spring male sterile lines from Germany and Canada as testers were crossed with 13 Chinese semi-winter rapeseed lines to develop 52 hybrids, which were evaluated together with their parents and commercial hybrids for seed yield and oil content in three sets of field trials with 8 environments in Canada and Europe. The Chinese parental lines were not adapted to local environmental conditions as demonstrated by poor seed yields per se. However, the hybrids between the Chinese parents and the adapted spring rapeseed lines exhibited high heterosis for seed yield. The average mid-parent heterosis was 15% and ca. 50% of the hybrids were superior to the respective hybrid control across three sets of field trials. Additive gene effects mainly contributed to hybrid performance since the mean squares of GCA were higher as compared to SCA. The correlation between parental GD and hybrid performance and heterosis was found to be low whereas the correlation between GCA((f + m)) and hybrid performance was high and significant in each set of field trials, with an average of r = 0.87 for seed yield and r = 0.89 for oil content, indicating that hybrid performance can be predicted by GCA((f + m)). These results demonstrate that Chinese semi-winter rapeseed germplasm has a great potential to increase seed yield in spring rapeseed hybrid breeding programs in Canada and Europe.

Paramedic Initiation of Neuroprotective Agent Infusions: Successful Achievement of Target Blood Levels and Attained Level Effect on Clinical Outcomes in the FAST-MAG Pivotal Trial (Field Administration of Stroke Therapy - Magnesium).

PubMed

Shkirkova, Kristina; Starkman, Sidney; Sanossian, Nerses; Eckstein, Marc; Stratton, Samuel; Pratt, Frank; Conwit, Robin; Hamilton, Scott; Sharma, Latisha; Liebeskind, David; Restrepo, Lucas; Valdes-Sueiras, Miguel; Saver, Jeffrey L

2017-07-01

Paramedic use of fixed-size lumen, gravity-controlled tubing to initiate intravenous infusions in the field may allow rapid start of neuroprotective therapy for acute stroke. In a large, multicenter trial, we evaluated its efficacy in attaining target serum levels of candidate neuroprotective agent magnesium sulfate and the relation of achieved magnesium levels to outcome. The FAST-MAG phase 3 trial (Field Administration of Stroke Therapy - Magnesium) randomized 1700 patients within 2 hours of onset to paramedic-initiated, a 15-minute loading intravenous infusion of magnesium or placebo followed by a 24-hour maintenance dose. The drug delivery strategy included fixed-size lumen, gravity-controlled tubing for field drug administration, and a shrink-wrapped ambulance kit containing both the randomized field loading and hospital maintenance doses for seamless continuation. Among patient randomized to active treatment, magnesium levels in the first 72 hours were assessed 987 times in 572 patients. Mean patient age was 70 years (SD±14 years), and 45% were women. During the 24-hour period of active infusion, mean achieved serum level was 3.91 (±0.8), consistent with trial target. Mg levels were increased by older age, female sex, lower weight, height, body mass index, and estimated glomerular filtration rate, and higher blood urea nitrogen, hemoglobin, and higher hematocrit. Adjusted odds for clinical outcomes did not differ by achieved Mg level, including disability at 90 days, symptomatic hemorrhage, or death. Paramedic infusion initiation using gravity-controlled tubing permits rapid achievement of target serum levels of potential neuroprotective agents. The absence of association of clinical outcomes with achieved magnesium levels provides further evidence that magnesium is not biologically neuroprotective in acute stroke. © 2017 American Heart Association, Inc.

Comparison Of trap types and colors for capturing emerald ash borer adults at different population densities

Treesearch

Therese M. Poland; Deborah G. Mccullough

2014-01-01

Results of numerous trials to evaluate artificial trap designs and lures for detection of Agrilus planipennis Fairmaire, the emerald ash borer, have yielded inconsistent results, possibly because of different A. planipennis population densities in the field sites. In 2010 and 2011, we compared 1) green canopy traps, 2) purple...

Evaluation of field performance of poplar clones using selected competition indices.

Treesearch

Chandler Brodie; D.S. DeBell

2004-01-01

Use of competition indices in the analysis of forestry experiments may improve detection and understanding of treatment effects, and thereby improve the application of results. In this paper, we compared the performance of eight indices in an analysis of a spacing trial of four Populus clones planted in pure and mixed clonal plots. Indices were...

Gas chromatography-mass spectrometry (GC-MS) analysis of extractives of naturally durable wood

Treesearch

G.T. Kirker; A.B. Blodgett; S.T. Lebow; C.A. Clausen

2011-01-01

A preliminary study to evaluate naturally durable wood species in an above ground field trial using Gas Chromatography-Mass Spectrometry (GC-MS) detected differences in fatty acid extractives between species and within the same species over time. Fatty acids were extracted with chloroform: methanol mixture then methylated with sodium methoxide and fractionated using...

Combinations of corn glutel meal, clove oil, and sweep cultivation are ineffective for weed control in organic peanut production

USDA-ARS?s Scientific Manuscript database

Weed control in organic peanut is difficult and lack of residual weed control complicates weed management efforts. Weed management systems using corn gluten meal in combination with clove oil and sweep cultivation were evaluated in a series of irrigated field trials. Corn gluten meal applied in a ...

Ten-year growth comparison between rooted cuttings and seedlings of loblolly pine

Treesearch

H.E. Stelzer; G. Sam Foster; D.V. Shaw; J.B. McRae

1997-01-01

Rooted cuttings and seedlings of loblolly pine (Pinus taeda L.) were established in a central Alabama field trial. Five, full-sib families, with an average number of six clones per family, were evaluated. Mean cutting/seedling height ratios revealed that despite initial differences in size, relative growth rates of both propagule types stabilized and...

Using a Mobile Application to Support Children's Writing Motivation

ERIC Educational Resources Information Center

Kanala, Sari; Nousiainen, Tuula; Kankaanranta, Marja

2013-01-01

Purpose: The purpose of this paper is to explore the use of the prototype of a mobile application for the enhancement of children's motivation for writing. The results are explored from students' and experts' perspectives. Design/methodology/approach: This study is based on a field trial and expert evaluations of a prototype of a mobile…

Effects of climate on growth traits of river red gum are determined by respiration parameters

Treesearch

Richard S. Criddle; Thimmappa S. Anekonda; Sharon Tong; John N. Church; F. Thomas Ledig; Lee D. Hansen

2000-01-01

Temperature is the major uncontrollable climate variable in plantation forestry. Matching plants to climate is essential for optimizing growth. Matching is usually done with field trials because of the lack of a predictive relation between laboratory measurements of physiological responses and climatic factors affecting growth. This paper evaluates the potential of...

The use of disease severity variables in predicting efficacy of FOV4 resistance selection

USDA-ARS?s Scientific Manuscript database

In 2015, 85 Upland (Gossypium hirsutum L.) accessions from the USDA-ARS Cotton Collection and 126 F6 Pima-S6 x Pima-S7 (G. barbadense L.) recombinant inbred lines were evaluated for disease performance under pressure of Fusarium oxysporum f. sp. vasinfectum race 4 (FOV4) in a replicated field trial ...

Production, Cost and Chip Characteristics of In-Woods Microchipping

Treesearch

J. Thompson; W. Sprinkle

2013-01-01

Emerging markets for biomass have increased the interest in producing microchips in the field. As a component of a large United States Department of Energy (DOE) funded project, microchipping has been trialed on a limited scale. The goal of the research was to evaluate the production, cost and chip characteristics of a mobile disc chipper configured to produce...

76 FR 48119 - Oral Rabies Vaccine Trial; Availability of a Risk Assessment and an Environmental Assessment

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-08

...] Oral Rabies Vaccine Trial; Availability of a Risk Assessment and an Environmental Assessment AGENCY... environmental assessment relative to an oral rabies vaccination field trial in West Virginia. The environmental... rabies vaccine, analyzes the use of that vaccine in field safety and efficacy trials in West Virginia...

Designing a field trial of an equine grass sickness vaccine: A questionnaire-based feasibility study.

PubMed

Ireland, Joanne L; McGorum, Bruce C; Proudman, Christopher J; Newton, J Richard

2016-07-01

Without an experimental model of equine grass sickness (EGS), a randomised controlled field trial (RCT) represents the only method of evaluating the efficacy of Clostridium botulinum type C vaccination in preventing naturally occurring disease. Clinical trial feasibility is an important aspect of preliminary work undertaken prior to initiating RCTs, estimating parameters that are important for study design. This cross-sectional study aimed to assess the feasibility of conducting a nationwide RCT of a candidate vaccine for EGS based on responses from a sample of British equine veterinary practices (n = 119/284). Seventy-three percent of practices had attended ≥1 EGS case within the preceding 2 years (median four cases), and 51.3% regularly attended recurrently affected premises. Veterinary surgeons had greater confidence diagnosing acute/subacute EGS based solely on history and clinical signs compared to chronic EGS. Ninety-one percent of respondents (n = 103/113) considered the proposed RCT to be important/very important to equine veterinary research. Ninety-one percent of respondents (n = 102/112) indicated preparedness to assist in owner recruitment and 92.9% (n = 104/112) indicated willingness to participate in a RCT. The most frequent reasons for practices declining to participate were low incidence of EGS (n = 4), did not believe clients would wish to participate (n = 3) and amount of paperwork/data collection involved (n = 2). There was considerable support amongst participating veterinary practices for a RCT evaluating the efficacy of Clostridium botulinum vaccination for the prevention of EGS in Britain. Substantial proportions of participating practices would be prepared to participate in the RCT and regularly attended EGS-affected premises that would meet trial inclusion criteria. Copyright © 2016 Elsevier Ltd. All rights reserved.

Quality Control of Involved Field Radiotherapy in Patients With Early-Favorable (HD10) and Early-Unfavorable (HD11) Hodgkin's Lymphoma: An Analysis of the German Hodgkin Study Group

DOE Office of Scientific and Technical Information (OSTI.GOV)

Eich, Hans Theodor; Engenhart-Cabillic, Rita; Hansemann, Katja

2008-08-01

Purpose: The German Hodgkin Study Group (GHSG) set up a radiotherapy (RT) reference center within the Department of Radiation Oncology at University of Cologne to undertake quality assurance of the group's clinical studies. In the HD10 trial (early-favorable stages) and HD11 trial (early-unfavorable stages) all patients received involved field (IF)-RT (30 Gy vs. 20 Gy) within a combined-modality approach. For these patients a central prospective review of all diagnostic imaging was performed by expert radiation oncologists to control disease extension and to define IF treatment volume. Methods and Materials: On the basis of simulation films, verification films, and radiotherapy casemore » report form (CRF) an expert panel evaluated retrospectively the adequacy of irradiated IF treatment portals according to the RT prescription, applied radiation doses, treatment time, and technical parameters. Results: Between 1999 and 2006 a total of 825 of 1370 randomized patients of the HD10 trial (60%) and 954 of 1422 patients of the HD11 trial (67%) were evaluated by the panel. Radiotherapy was rated as suboptimal in 47% of all reviewed cases. Although the participating RT centers received a precise RT prescription, most difficulties occurred in the adequate coverage of the IF (40%), followed by technical faults (12%). Deviations from the prescribed single daily dose (1.8-2 Gy), weekly dose, and total reference dose were rare (1%). Conclusions: As a consequence of these findings, radiation oncologists were trained on the definition of IF-RT at GHSG meetings and at the annual meetings of the German Society for Therapeutic Radiation Oncology. Possible correlations between RT quality and relapse rate will be investigated.« less

An Internal Review and Operational Trial of a Human Factors Engineering Self-Paced Course in Accordance with the Instructional Systems Development Process.

DTIC Science & Technology

1983-12-01

factors aspects of systems and equipments. 6. Identify the human factors principles which must be applied during the evaluation of a workspace and control...Curriculum Development Expert Questionnaires Three proven specialists in the field of curriculum evaluation who regularly apply the standards and criteria 67...which each terminal objective met each of the six criteria listed in Appendix E. Ordinal values ranging from 1 through 4, were applied to the verbal

The personalized reminder information and social management system (PRISM) trial: rationale, methods and baseline characteristics.

PubMed

Czaja, Sara J; Boot, Walter R; Charness, Neil; A Rogers, Wendy; Sharit, Joseph; Fisk, Arthur D; Lee, Chin Chin; Nair, Sankaran N

2015-01-01

Technology holds promise in terms of providing support to older adults. To date, there have been limited robust systematic efforts to evaluate the psychosocial benefits of technology for older people and identify factors that influence both the usability and uptake of technology systems. In response to these issues, we developed the Personal Reminder Information and Social Management System (PRISM), a software application designed for older adults to support social connectivity, memory, knowledge about topics, leisure activities and access to resources. This trail is evaluating the impact of access to the PRISM system on outcomes such as social isolation, social support and connectivity. This paper reports on the approach used to design the PRISM system, study design, methodology and baseline data for the trial. The trial is multi-site randomized field trial. PRISM is being compared to a Binder condition where participants received a binder that contained content similar to that found on PRISM. The sample includes 300 older adults, aged 65-98 years, who lived alone and at risk for being isolated. The primary outcome measures for the trial include indices of social isolation and support and well-being. Secondary outcomes measures include indices of computer proficiency, technology uptake and attitudes towards technology. Follow-up assessments occurred at 6 and 12 months post-randomization. The results of this study will yield important information about the potential value of technology for older adults. The study also demonstrates how a user-centered iterative design approach can be incorporated into the design and evaluation of an intervention protocol. Copyright © 2014 Elsevier Inc. All rights reserved.

The Personalized Reminder Information and Social Management System (PRISM) Trial: Rationale, Methods and Baseline Characteristics

PubMed Central

Czaja, Sara J.; Boot, Walter R.; Charness, Neil; Rogers, Wendy; Sharit, Joseph; Fisk, Arthur D.; Lee, Chin Chin; Nair, Sankaran N.

2014-01-01

Technology holds promise in terms of providing support to older adults. To date there have been limited robust systematic efforts to evaluate the psychosocial benefits of technology for older people and identify factors that influence both the usability and uptake of technology systems. In response to these issues we developed the Personal Reminder Information and Social Management System (PRISM), a software application designed for older adults to support social connectivity, memory, knowledge about topics, leisure activities and access to resources. This trail is evaluating the impact of access to the PRISM system on outcomes such as social isolation, social support and connectivity. This paper reports on the approach used to design the PRISM system, study design, methodology and baseline data for the trial. The trial is multi-site randomized field trial. PRISM is being compared to a Binder condition where participants received a binder that contained content similar to that found on PRISM. The sample includes 300 older adults, aged 65 – 98 years, who lived alone and at risk for being isolated. The primary outcome measures for the trial include indices of social isolation and support and well-being. Secondary outcomes measures include indices of computer proficiency, technology uptake and attitudes towards technology. Follow-up assessments occurred at 6 and 12 months post-randomization. The results of this study will yield important information about the potential value of technology for older adults. The study also demonstrates how a user-centered iterative design approach can be incorporated into the design and evaluation of an intervention protocol. PMID:25460342

Designing malaria vaccines to circumvent antigen variability✩

PubMed Central

Ouattara, Amed; Barry, Alyssa E.; Dutta, Sheetij; Remarque, Edmond J.; Beeson, James G.; Plowe, Christopher V.

2016-01-01

Prospects for malaria eradication will be greatly enhanced by an effective vaccine, but parasite genetic diversity poses a major impediment to malaria vaccine efficacy. In recent pre-clinical and field trials, vaccines based on polymorphic Plasmodium falciparum antigens have shown efficacy only against homologous strains, raising the specter of allele-specific immunity such as that which plagues vaccines against influenza and HIV. The most advanced malaria vaccine, RTS,S, targets relatively conserved epitopes on the P. falciparum circumsporozoite protein. After more than 40 years of development and testing, RTS,S, has shown significant but modest efficacy against clinical malaria in phase 2 and 3 trials. Ongoing phase 2 studies of an irradiated sporozoite vaccine will ascertain whether the full protection against homologous experimental malaria challenge conferred by high doses of a whole organism vaccine can provide protection against diverse strains in the field. Here we review and evaluate approaches being taken to design broadly cross-protective malaria vaccines. PMID:26475447

A Bayesian Approach to Estimating Coupling Between Neural Components: Evaluation of the Multiple Component, Event-Related Potential (mcERP) Algorithm

NASA Technical Reports Server (NTRS)

Shah, Ankoor S.; Knuth, Kevin H.; Truccolo, Wilson A.; Ding, Ming-Zhou; Bressler, Steven L.; Schroeder, Charles E.; Clancy, Daniel (Technical Monitor)

2002-01-01

Accurate measurement of single-trial responses is key to a definitive use of complex electromagnetic and hemodynamic measurements in the investigation of brain dynamics. We developed the multiple component, Event-Related Potential (mcERP) approach to single-trial response estimation. To improve our resolution of dynamic interactions between neuronal ensembles located in different layers within a cortical region and/or in different cortical regions. The mcERP model assets that multiple components defined as stereotypic waveforms comprise the stimulus-evoked response and that these components may vary in amplitude and latency from trial to trial. Maximum a posteriori (MAP) solutions for the model are obtained by iterating a set of equations derived from the posterior probability. Our first goal was to use the ANTWERP algorithm to analyze interactions (specifically latency and amplitude correlation) between responses in different layers within a cortical region. Thus, we evaluated the model by applying the algorithm to synthetic data containing two correlated local components and one independent far-field component. Three cases were considered: the local components were correlated by an interaction in their single-trial amplitudes, by an interaction in their single-trial latencies, or by an interaction in both amplitude and latency. We then analyzed the accuracy with which the algorithm estimated the component waveshapes and the single-trial parameters as a function of the linearity of each of these relationships. Extensions of these analyses to real data are discussed as well as ongoing work to incorporate more detailed prior information.

InterGeo II: International Geographical Achievement Test. Field Trials Report and Test (Secondary Schools, Grade 8).

ERIC Educational Resources Information Center

Niemz, Gunter; Stoltman, Joseph P.

InterGeo II, a project of the Commission on Geographical Education (CGE) of the International Geographical Union (IGU), has developed a broadly based, field-trialed testing instrument for making cross-national comparisons of achievement in geography. Field trials of InterGeo II were held in 23 countries. Data were analyzed for national achievement…

A core outcome set for all types of cardiac surgery effectiveness trials: a study protocol for an international eDelphi survey to achieve consensus on what to measure and the subsequent selection of measurement instruments.

PubMed

Moza, A; Benstoem, C; Autschbach, R; Stoppe, C; Goetzenich, A

2015-12-02

Cardiovascular disease (CVD) is a major contributor to the burden of disease and the number one cause of death worldwide. From 1990 until today, more people died from coronary heart disease than from any other cause. CVD is regularly treated with minimally or non-minimally invasive off- or on-pump cardiothoracic surgery and several interventions related to the outcome of the surgical procedures have been evaluated in clinical trials, but heterogeneity in outcome reporting hinders comparison of interventions across trials and limits the ability of research synthesis. This problem is encountered with the introduction of core outcome sets (COSs), which should be measured and reported, as a minimum, in all clinical trials for a specific clinical field. This study protocol describes the methods used to develop a COS for all types of cardiac surgery effectiveness trials. We aim to reach consensus on what to measure in an international three-round eDelphi exercise involving adult patients in need or after cardiothoracic surgery, cardiothoracic surgeons, cardiologists, anaesthesiologists, nursing staff and researchers with expertise in this particular field of medical research. Subsequently, outcome measurement instruments (how to measure) will be determined. Recommendations on COS development given by the Core Outcome Measures in Effectiveness Trials (COMET) Initiative and the Outcome Measures in Rheumatology (OMERACT) Initiative were followed. The proposed COS aims to provide methodological guidance for future cardiothoracic surgical trials to ensure the comparability of effects of interventions across studies and enable research synthesis. This does not imply that primary outcomes should always and exclusively be those of the COS. However, to ensure the comparability of results across trials, the outcomes included in this COS should be considered for inclusion besides measuring trial-specific clinical endpoints.

Field trial of insect-resistant and herbicide-tolerant genetically modified cotton (Gossypium hirsutum L.) for environmental risk assessment in Japan.

PubMed

Asanuma, Yoko; Gondo, Takahiro; Ishigaki, Genki; Inoue, Koichi; Zaita, Norihiro; Muguerza, Melody; Akashi, Ryo

2017-04-03

Japan imports cottonseed mainly from Australia and the USA where more than 96% of all cotton varieties grown are genetically modified (GM). GM crops undergo an environmental risk assessment (ERA) under the Law Concerning the Conservation and Sustainable Use of Biological Diversity before import into Japan. Potential adverse effects on biodiversity are comprehensively assessed based on competitiveness, production of harmful substances and outcrossing ability. Even though imported cottonseed is intended for food and feed uses and not for cultivation, the potential risks from seed spillage during transport must be evaluated. In most cases, the ERA requires data collected from in-country field trials to demonstrate how the GM crop behaves in Japan's environment. Confined field trials in Japan were conducted for the ERA of Lepidoptera-resistant and glufosinate-tolerant GM cotton (Gossypium hirsutum L.) lines GHB119 and T304-40. These lines were compared with conventional varieties for growth habit, morphological characteristics, seed dormancy, and allelopathic activity associated with competitiveness and production of harmful substances. Outcrossing ability was not a concern due to the absence of sexually compatible wild relatives in Japan. Although slight statistical differences were observed between the GM line and its conventional comparator for some morphological characteristics, transgenes or transformation were not considered to be responsible for these differences. The trial demonstrated that competitiveness and production of harmful substances by these GM cotton lines were equivalent to conventional cotton varieties that have a long history of safe use, and no potential adverse effects to biosafety in Japan were observed.

Field trial of insect-resistant and herbicide-tolerant genetically modified cotton (Gossypium hirsutum L.) for environmental risk assessment in Japan

PubMed Central

Asanuma, Yoko; Gondo, Takahiro; Ishigaki, Genki; Inoue, Koichi; Zaita, Norihiro; Muguerza, Melody; Akashi, Ryo

2017-01-01

ABSTRACT Japan imports cottonseed mainly from Australia and the USA where more than 96% of all cotton varieties grown are genetically modified (GM). GM crops undergo an environmental risk assessment (ERA) under the Law Concerning the Conservation and Sustainable Use of Biological Diversity before import into Japan. Potential adverse effects on biodiversity are comprehensively assessed based on competitiveness, production of harmful substances and outcrossing ability. Even though imported cottonseed is intended for food and feed uses and not for cultivation, the potential risks from seed spillage during transport must be evaluated. In most cases, the ERA requires data collected from in-country field trials to demonstrate how the GM crop behaves in Japan's environment. Confined field trials in Japan were conducted for the ERA of Lepidoptera-resistant and glufosinate-tolerant GM cotton (Gossypium hirsutum L.) lines GHB119 and T304-40. These lines were compared with conventional varieties for growth habit, morphological characteristics, seed dormancy, and allelopathic activity associated with competitiveness and production of harmful substances. Outcrossing ability was not a concern due to the absence of sexually compatible wild relatives in Japan. Although slight statistical differences were observed between the GM line and its conventional comparator for some morphological characteristics, transgenes or transformation were not considered to be responsible for these differences. The trial demonstrated that competitiveness and production of harmful substances by these GM cotton lines were equivalent to conventional cotton varieties that have a long history of safe use, and no potential adverse effects to biosafety in Japan were observed. PMID:28510512

[Decimeter-wave physiotherapy in viral hepatitis].

PubMed

Kents, V V; Mavrodiĭ, V M

1995-01-01

Effectiveness was evaluated of magnetotherapy, inductothermy, UNF electric field and electromagnetic waves of decimetric wave band (460 MHz) on the projection of the liver, adrenals and thyroid gland in controlled trials enrolling a total of 835 patients with viral hepatitis (type A, B, associated forms). A conclusion is reached that optimum effectiveness of decimetric field on the projection of the adrenals and thyroid gland can be achieved through the application of minimum power and everyday alternation of exposures. It has been estimated that as many as 69 percent of the patients derive benefit from the above treatment.

Experience and challenges from clinical trials with malaria vaccines in Africa.

PubMed

Mwangoka, Grace; Ogutu, Bernhards; Msambichaka, Beverly; Mzee, Tutu; Salim, Nahya; Kafuruki, Shubis; Mpina, Maxmillian; Shekalaghe, Seif; Tanner, Marcel; Abdulla, Salim

2013-03-04

Malaria vaccines are considered amongst the most important modalities for potential elimination of malaria disease and transmission. Research and development in this field has been an area of intense effort by many groups over the last few decades. Despite this, there is currently no licensed malaria vaccine. Researchers, clinical trialists and vaccine developers have been working on many approached to make malaria vaccine available.African research institutions have developed and demonstrated a great capacity to undertake clinical trials in accordance to the International Conference on Harmonization-Good Clinical Practice (ICH-GCP) standards in the last decade; particularly in the field of malaria vaccines and anti-malarial drugs. This capacity is a result of networking among African scientists in collaboration with other partners; this has traversed both clinical trials and malaria control programmes as part of the Global Malaria Action Plan (GMAP). GMAP outlined and support global strategies toward the elimination and eradication of malaria in many areas, translating in reduction in public health burden, especially for African children. In the sub-Saharan region the capacity to undertake more clinical trials remains small in comparison to the actual need.However, sustainability of the already developed capacity is essential and crucial for the evaluation of different interventions and diagnostic tools/strategies for other diseases like TB, HIV, neglected tropical diseases and non-communicable diseases. There is urgent need for innovative mechanisms for the sustainability and expansion of the capacity in clinical trials in sub-Saharan Africa as the catalyst for health improvement and maintained.

Psychopharmacology curriculum field test.

PubMed

Zisook, Sidney; Balon, Richard; Benjamin, Sheldon; Beresin, Eugene; Goldberg, David A; Jibson, Michael D; Thrall, Grace

2009-01-01

As part of an effort to improve psychopharmacology training in psychiatric residency programs, a committee of residency training directors and associate directors adapted an introductory schizophrenia presentation from the American Society of Clinical Psychopharmacology's Model Psychopharmacology Curriculum to develop a multimodal, interactive training module. This article describes the module, its development, and the results of a field trial to test its feasibility and usefulness. Nineteen residency programs volunteered to use the module during the first half of the 2007-2008 academic year. Evaluation consisted of a structured phone interview with the training director or teaching faculty of participating programs during February and early March 2008, asking whether and how they used the curriculum, which components they found most useful, and how it was received by faculty and residents. Of the 19 programs, 14 used the module and 13 participated in the evaluation. The most commonly used components were the pre- and postmodule questions, video-enhanced presentation, standard presentation, problem- or team-based teaching module, and other problem-based teaching modules. No two programs used the module in the same fashion, but it was well received by instructors and residents regardless of use. The results of this field trial suggest that a dynamic, adult-centered curriculum that is exciting, innovative, and informative enough for a wide variety of programs can be developed; however, the development and programmatic barriers require considerable time and effort to overcome.

An evaluation of pollination mechanisms for purple prairie-clover, Dalea purpurea (Fabaceae: Amorpheae)

Treesearch

James H. Cane

2006-01-01

Purple prairie-clover (Dalea purpurea Ventenat) is a common perennial forb that flowers during mid-summer throughout the Great Plains and adjacent biomes. Seed of D. purpurea is used for prairie restoration. This study characterizes the reproductive biology of D. purpurea. Manual pollination field trials showed that D. purpurea has a mixed pollination system. It is...

The Relation of the Response Distribution to Self-Report Questionnaire Items and Cognitive Ability among School-Aged Children

ERIC Educational Resources Information Center

Stapleton, Laura M.; Reiner, Laura S.; Aluvathingal, Anu J.

2010-01-01

This proposed research is part of an on-going line of research of developing questionnaire instruments for use at the elementary school level. Because field trials often use child self-report as outcome measures and sometimes determine implementation fidelity using such measures, evaluation of the validity of the use of such measures with…

Adding microencapsulated pear ester to insecticides for control of Cydia pomonella (Lepidoptera:Tortricidae) in apple

USDA-ARS?s Scientific Manuscript database

We evaluated whether the efficacy of various insecticides for codling moth, Cydia pomonella (L.), could be improved with the addition of a microencapsulated formulation of pear ester, ethyl (2E, 4Z)-2,4-decadienoate (PE-MEC, 5% AI), in field trials from 2005 to 2009. The addition of PE-MEC (< 3.0 g ...

Extensions of Existing Methods for Use with a New Class of Experimental Designs Useful when There Is Treatment Effect Contamination

ERIC Educational Resources Information Center

Rhoads, Christopher

2011-01-01

Researchers planning a randomized field trial to evaluate the effectiveness of an educational intervention often face the following dilemma. They plan to recruit schools to participate in their study. The question is, "Should the researchers randomly assign individuals (either students or teachers, depending on the intervention) within schools to…

Control of fire blight by Pseudomonas fluorescens A506 and Pantoea vagans C9-1 applied as single strains and mixed inocula

USDA-ARS?s Scientific Manuscript database

The biological control agents Pseudomonas fluorescens A506 and Pantoea vagans C9-1 were evaluated individually and in combination for the suppression of fire blight of pear or apple in ten field trials inoculated with the pathogen Erwinia amylovora. The formulation of pathogen inoculum applied to b...

Taking Science Online: Evaluating Presence and Immersion through a Laboratory Experience in a Virtual Learning Environment for Entomology Students

ERIC Educational Resources Information Center

Annetta, Leonard; Klesath, Marta; Meyer, John

2009-01-01

A 3-D virtual field trip was integrated into an online college entomology course and developed as a trial for the possible incorporation of future virtual environments to supplement online higher education laboratories. This article provides an explanation of the rationale behind creating the virtual experience, the Bug Farm; the method and…

Bulletin of University of Agricultural Sciences and Veterinary Medicine Cluj-Napoca

USDA-ARS?s Scientific Manuscript database

Transgenic clones C2, C3, C4, C5, C6, PT3 and PT5 of Prunus domestica L. transformed with the Plum pox virus coat protein gene (PPV-CP) were evaluated for Sharka resistance under high infection pressure in field trials in Romania. Transgenic clone C5, subsequently named "HoneySweet", showed high re...

Effects of an Internet-Based Educational Intervention to Prevent High-Risk Sexual Behavior in Mexican Adolescents

ERIC Educational Resources Information Center

Doubova, Svetlana V.; Martinez-Vega, Ingrid Patricia; Infante-Castañeda, Claudia; Pérez-Cuevas, Ricardo

2017-01-01

To evaluate the effect of an internet-based educational intervention to increase knowledge of sexually transmitted infections (STIs), attitudes and self-efficacy toward consistent condom use in Mexican adolescents. A field trial with an intervention and control group was conducted in 14- to 15-year-old students in two secondary schools. The…

Evaluation of soybean breeding lines for resistance to Phomopsis seed decay: Results of 2014, 2015, and 2016 field trials in Stoneville, Mississippi

USDA-ARS?s Scientific Manuscript database

Soybean [Glycine max (L.) Merr.] is one of the most important crops in the world. Phomopsis seed decay (PSD) is a soybean seed disease that causes poor seed quality. This disease is caused primarily by a fungal pathogen, Phomopsis longicolla (syn. Diaporthe longicolla). Planting PSD-resistant soybea...

Advancing Early Detection of Autism Spectrum Disorder by Applying an Integrated Two-Stage Screening Approach

ERIC Educational Resources Information Center

Oosterling, Iris J.; Wensing, Michel; Swinkels, Sophie H.; van der Gaag, Rutger Jan; Visser, Janne C.; Woudenberg, Tim; Minderaa, Ruud; Steenhuis, Mark-Peter; Buitelaar, Jan K.

2010-01-01

Background: Few field trials exist on the impact of implementing guidelines for the early detection of autism spectrum disorders (ASD). The aims of the present study were to develop and evaluate a clinically relevant integrated early detection programme based on the two-stage screening approach of Filipek et al. (1999), and to expand the evidence…

Impact of No-till Cover Cropping of Italian Ryegrass on Above and Below Ground Faunal Communities Inhabiting a Soybean Field with Emphasis on Soybean Cyst Nematodes.

PubMed

Hooks, Cerruti R R; Wang, Koon-Hui; Meyer, Susan L F; Lekveishvili, Mariam; Hinds, Jermaine; Zobel, Emily; Rosario-Lebron, Armando; Lee-Bullock, Mason

2011-09-01

Two field trials were conducted between 2008 and 2010 in Maryland to evaluate the ability of an Italian ryegrass (IR) (Lolium multiflorum) cover crop to reduce populations of plant-parasitic nematodes while enhancing beneficial nematodes, soil mites and arthropods in the foliage of a no-till soybean (Glycine max) planting. Preplant treatments were: 1) previous year soybean stubble (SBS); and 2) herbicide-killed IR cover crop + previous year soybean stubble (referred to as IR). Heterodera glycines population densities were very low and no significant difference in population densities of H. glycines or Pratylenchus spp. were observed between IR and SBS. Planting of IR increased abundance of bacterivorous nematodes in 2009. A reverse trend was observed in 2010 where SBS had higher abundance of bacterivorous nematodes and nematode richness at the end of the cover cropping period. Italian ryegrass also did not affect insect pests on soybean foliage. However, greater populations of spiders were found on soybean foliage in IR treatments during both field trials. Potential causes of these findings are discussed.

Osmotic therapies added to antibiotics for acute bacterial meningitis.

PubMed

Wall, Emma Cb; Ajdukiewicz, Katherine Mb; Bergman, Hanna; Heyderman, Robert S; Garner, Paul

2018-02-06

Every day children and adults die from acute community-acquired bacterial meningitis, particularly in low-income countries, and survivors risk deafness, epilepsy and neurological disabilities. Osmotic therapies may attract extra-vascular fluid and reduce cerebral oedema, and thus reduce death and improve neurological outcomes.This is an update of a Cochrane Review first published in 2013. To evaluate the effects of osmotic therapies added to antibiotics for acute bacterial meningitis in children and adults on mortality, deafness and neurological disability. We searched CENTRAL (2017, Issue 1), MEDLINE (1950 to 17 February 2017), Embase (1974 to 17 February 2017), CINAHL (1981 to 17 February 2017), LILACS (1982 to 17 February 2017) and registers of ongoing clinical trials (ClinicalTrials.com, WHO ICTRP) (21 February 2017). We also searched conference abstracts and contacted researchers in the field (up to 12 December 2015). Randomised controlled trials testing any osmotic therapy in adults or children with acute bacterial meningitis. Two review authors independently screened the search results and selected trials for inclusion. Results are presented using risk ratios (RR) and 95% confidence intervals (CI) and grouped according to whether the participants received steroids or not. We used the GRADE approach to assess the certainty of the evidence. We included five trials with 1451 participants. Four trials evaluated glycerol against placebo, and one evaluated glycerol against 50% dextrose; in addition three trials evaluated dexamethasone and one trial evaluated acetaminophen (paracetamol) in a factorial design. Stratified analysis shows no effect modification with steroids; we present aggregate effect estimates.Compared to placebo, glycerol probably has little or no effect on death in people with bacterial meningitis (RR 1.08, 95% CI 0.90 to 1.30; 5 studies, 1272 participants; moderate-certainty evidence), but may reduce neurological disability (RR 0.73, 95% CI 0.53 to 1.00; 5 studies, 1270 participants; low-certainty evidence).Glycerol may have little or no effect on seizures during treatment for meningitis (RR 1.08, 95% CI 0.90 to 1.30; 4 studies, 1090 participants; low-certainty evidence).Glycerol may reduce the risk of subsequent deafness (RR 0.64, 95% CI 0.44 to 0.93; 5 studies, 922 participants; low to moderate-certainty evidence).Glycerol probably has little or no effect on gastrointestinal bleeding (RR 0.93, 95% CI 0.39 to 2.19; 3 studies, 607 participants; moderate-certainty evidence). The evidence on nausea, vomiting and diarrhoea is uncertain (RR 1.09, 95% CI 0.81 to 1.47; 2 studies, 851 participants; very low-certainty evidence). Glycerol was the only osmotic therapy evaluated, and data from trials to date have not demonstrated an effect on death. Glycerol may reduce neurological deficiency and deafness.

Pulsed Electromagnetic Fields in the treatment of fresh scaphoid fractures. A multicenter, prospective, double blind, placebo controlled, randomized trial

PubMed Central

2011-01-01

Background The scaphoid bone is the most commonly fractured of the carpal bones. In the Netherlands 90% of all carpal fractures is a fracture of the scaphoid bone. The scaphoid has an essential role in functionality of the wrist, acting as a pivot. Complications in healing can result in poor functional outcome. The scaphoid fracture is a troublesome fracture and failure of treatment can result in avascular necrosis (up to 40%), non-union (5-21%) and early osteo-arthritis (up to 32%) which may seriously impair wrist function. Impaired consolidation of scaphoid fractures results in longer immobilization and more days lost at work with significant psychosocial and financial consequences. Initially Pulsed Electromagnetic Fields was used in the treatment of tibial pseudoarthrosis and non-union. More recently there is evidence that physical forces can also be used in the treatment of fresh fractures, showing accelerated healing by 30% and 71% reduction in nonunion within 12 weeks after initiation of therapy. Until now no double blind randomized, placebo controlled trial has been conducted to investigate the effect of this treatment on the healing of fresh fractures of the scaphoid. Methods/Design This is a multi center, prospective, double blind, placebo controlled, randomized trial. Study population consists of all patients with unilateral acute scaphoid fracture. Pregnant women, patients having a life supporting implanted electronic device, patients with additional fractures of wrist, carpal or metacarpal bones and pre-existing impairment in wrist function are excluded. The scaphoid fracture is diagnosed by a combination of physical and radiographic examination (CT-scanning). Proven scaphoid fractures are treated with cast immobilization and a small Pulsed Electromagnetic Fields bone growth stimulating device placed on the cast. Half of the devices will be disabled at random in the factory. Study parameters are clinical consolidation, radiological consolidation evaluated by CT-scanning, functional status of the wrist, including assessment by means of the patient rated wrist evaluation (PRWE) questionnaire and quality of life using SF-36 health survey questionnaire. Primary endpoint is number of scaphoid unions at six weeks, secondary endpoints are time interval to clinical and radiological consolidation, number of non-unions, functional status at 52 weeks and non-adherence to the treatment protocol. Trial registration Netherlands Trial Register (NTR): NTR2064 PMID:21548951

The influence of an uncertain force environment on reshaping trial-to-trial motor variability.

PubMed

Izawa, Jun; Yoshioka, Toshinori; Osu, Rieko

2014-09-10

Motor memory is updated to generate ideal movements in a novel environment. When the environment changes every trial randomly, how does the brain incorporate this uncertainty into motor memory? To investigate how the brain adapts to an uncertain environment, we considered a reach adaptation protocol where individuals practiced moving in a force field where a noise was injected. After they had adapted, we measured the trial-to-trial variability in the temporal profiles of the produced hand force. We found that the motor variability was significantly magnified by the adaptation to the random force field. Temporal profiles of the motor variance were significantly dissociable between two different types of random force fields experienced. A model-based analysis suggests that the variability is generated by noise in the gains of the internal model. It further suggests that the trial-to-trial motor variability magnified by the adaptation in a random force field is generated by the uncertainty of the internal model formed in the brain as a result of the adaptation.

Development of an Attract-and-Kill Strategy for Drosophila suzukii (Diptera: Drosophilidae): Evaluation of Attracticidal Spheres Under Laboratory and Field Conditions.

PubMed

Rice, Kevin B; Short, Brent D; Leskey, Tracy C

2017-04-01

Drosophila suzukii Matsumura (Diptera: Drosophilidae) is an invasive, polyphagous fruit fly that attacks soft-skinned fruits. Originally from Asia, D. suzukii has successfully invaded the United States and the European and South American countries. At present, calendar-based insecticide applications are used to combat D. suzukii. Here, we evaluate a behaviorally based attract-and-kill management technique using attracticidal spheres to reduce D. suzukii infestations in raspberries. In laboratory bioassays aimed at identifying effective toxicants, attracticidal spheres containing dinotefuran at 1.0% a.i. killed 100% of D. suzukii within 5 min. Spinetoram, spinosad, permethrin, lambda-cyhalothrin (CS) and lambda-cyhalothrin (WG), all at 1.0% a.i., killed 100% of D. suzukii within 24 h. In field trials, statistically equivalent infestation rates were recorded in raspberry plots protected by attracticidal spheres containing 1.0% a.i. spinetoram compared with standard weekly insecticide applications. In field trials using 1.0% a.i. dinotefuran, attracticidal spheres decreased D. suzukii infestations compared with control plots, but insecticide applications were more effective at reducing D. suzukii infestations, although differences in harvesting practices likely affected fly population densities and infestation rates in both years. Attracticidal spheres effectively attract and kill D. suzukii and reduce infestations rates under field conditions, indicating that this behavioral strategy holds promise in D. suzukii management. Published by Oxford University Press on behalf of Entomological Society of America 2017. This work is written by US Government employees and is in the public domain in the US.

Static Magnetic Field Therapy: A Critical Review of Treatment Parameters

PubMed Central

Wahbeh, Helané; Harling, Noelle; Connelly, Erin; Schiffke, Heather C.; Forsten, Cora; Gregory, William L.; Markov, Marko S.; Souder, James J.; Elmer, Patricia; King, Valerie

2009-01-01

Static magnetic field (SMF) therapy, applied via a permanent magnet attached to the skin, is used by people worldwide for self-care. Despite a lack of established SMF dosage and treatment regimens, multiple studies are conducted to evaluate SMF therapy effectiveness. Our objectives in conducting this review are to:(i) summarize SMF research conducted in humans; (ii) critically evaluate reporting quality of SMF dosages and treatment parameters and (iii) propose a set of criteria for reporting SMF treatment parameters in future clinical trials. We searched 27 electronic databases and reference lists. Only English language human studies were included. Excluded were studies of electromagnetic fields, transcranial magnetic stimulation, magnets placed on acupuncture points, animal studies, abstracts, posters and editorials. Data were extracted on clinical indication, study design and 10 essential SMF parameters. Three reviewers assessed quality of reporting and calculated a quality assessment score for each of the 10 treatment parameters. Fifty-six studies were reviewed, 42 conducted in patient populations and 14 in healthy volunteers. The SMF treatment parameters most often and most completely described were site of application, magnet support device and frequency and duration of application. Least often and least completely described were characteristics of the SMF: magnet dimensions, measured field strength and estimated distance of the magnet from the target tissue. Thirty-four (61%) of studies failed to provide enough detail about SMF dosage to permit protocol replication by other investigators. Our findings highlight the need to optimize SMF dosing parameters for individual clinical conditions before proceeding to a full-scale clinical trial. PMID:18955243

Three-day Field Treatment with Ingenol Disoxate (LEO 43204) for Actinic Keratosis: A Phase II Trial.

PubMed

Siegel, Daniel M; Tyring, Stephen; Nahm, Walter K; Østerdal, Marie Louise; Petersen, Astrid H; Berman, Brian

2017-12-01

OBJECTIVE: The purpose of this study was to evaluate the safety and efficacy of ingenol disoxate gel using a once-daily, three-day field treatment regimen in patients with actinic keratosis. DESIGN: This was a Phase II, multicenter, open-label trial (clinicaltrials.gov: NCT02305888). SETTING: The study was conducted in 20 trial sites in the United States. PARTICIPANTS: Participants included patients with 5 to 20 clinically typical actinic keratosis lesions on the full face/chest (250cm 2 ), scalp (25-250cm 2 ), or the trunk/extremities (250cm 2 ). MEASUREMENTS: We measured incidence of dose-limiting events based on local skin responses. Percentage reduction in actinic keratosis lesion count from baseline, complete clearance, and partial clearance (≥75%) of actinic keratosis lesions were assessed at Week 8. RESULTS: Nine of 63 (14.3%) patients in the face/chest group reported dose-limiting events; zero of 63 patients in the scalp group reported dose-limiting events; and 11 of 62 (17.7%) patients in the trunk/extremities group reported dose-limiting events. Mean composite local skin response scores peaked at Day 4, then rapidly declined, reaching or approaching baseline levels by Week 4. Less than five percent of patients reported severe adverse events; the most common treatment-related adverse events were application site pain and pruritus. The reduction in actinic keratosis lesion count was 78.9, 76.3, and 69.1 percent for the face/chest, scalp, and trunk/extremities groups, respectively. Complete clearance was achieved in 36.5, 39.7, and 22.6 percent of patients in the face/chest, scalp, and trunk/extremities groups, respectively. Partial clearance was achieved in 71.4, 65.1, and 50.0 percent of patients in the face/chest, scalp, and trunk/extremities groups, respectively. CONCLUSION: Ingenol disoxate demonstrated adverse events and local skin reaction profiles similar to results seen in trials evaluating shorter two-day regimens and was effective in patients with actinic keratosis. These data support the use of ingenol disoxate gel for actinic keratosis field treatment.

Small molecules as therapy for uveitis: a selected perspective of new and developing agents.

PubMed

Pleyer, Uwe; Algharably, Engi Abdel-Hady; Feist, Eugen; Kreutz, Reinhold

2017-09-01

Intraocular inflammation (uveitis) remains a significant burden of legal blindness. Because of its immune mediated and chronic recurrent nature, common therapy includes corticosteroids, disease-modifying anti-rheumatic drugs and more recently biologics as immune modulatory agents. The purpose of this article is to identify the role of new treatment approaches focusing on small molecules as therapeutic option in uveitis. Areas covered: A MEDLINE database search was conducted through February 2017 using the terms 'uveitis' and 'small molecule'. To provide ongoing and future perspectives in treatment options, also clinical trials as registered at ClinicalTrials.gov were included. Both, results from experimental as well as clinical research in this field were included. Since this field is rapidly evolving, a selection of promising agents had to be made. Expert opinion: Small molecules may interfere at different steps of the inflammatory cascade and appear as an interesting option in the treatment algorithm of uveitis. Because of their highly targeted molecular effects and their favorable bioavailability with the potential of topical application small molecules hold great promise. Nevertheless, a careful evaluation of these agents has to be made, since current experience is almost exclusively based on experimental uveitis models and few registered trials.

Bio-efficacy, physical integrity, community usage and washing practices of mosquito nets treated with ICON MAXX long-lasting insecticidal treatment in India

PubMed Central

Sahu, Sudhansu Sekhar; Gunasekaran, Kasinathan; Vijayakumar, Kilakootil Narayanan; Jambulingam, Purushothaman

2017-01-01

BACKGROUND New brands of potential long lasting insecticide nets (LLINs) and LLIN treatment kits require field evaluation before they are used in a vector control programme. OBJECTIVES The aim of this study was to evaluate the bio-efficacy, usage, washing practice and physical integrity of nets treated with LLIN treatment kit, ICON MAXX in a phase III field trial in Odisha state, India. METHODS A total of 300 polyester nets treated with ICON MAXX and 140 polyester nets treated conventionally with lambda-cyhalothrin CS 2.5% ITNs were distributed. The bio-efficacy was evaluated with WHO cone bioassay. The chemical analysis of netting pieces was done at the beginning, after 12 and 36 months of the trial. FINDINGS After one year of distribution of nets, the bioassay showed 100% mortality on both ITNs and ICON MAXX treated nets. At 36 months, the overall pass rate was 58.8% and the mean lambda-cyhalothrin content of LLINs was 34.5 mg ai/m2, showing a loss of 44.4% of the original concentration. CONCLUSION ICON MAXX treated LLIN was found to retain bio-efficacy causing 97% knockdown of Anopheles stephensi up to 30 months and met the WHOPES criteria. However, the desired bio-efficacy was not sustained up to 36 months. PMID:28125134

Visual Field Outcomes for the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT).

PubMed

Wall, Michael; Johnson, Chris A; Cello, Kimberly E; Zamba, K D; McDermott, Michael P; Keltner, John L

2016-03-01

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. 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. 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. 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.).

Enhancing biological control of basal stem rot disease (Ganoderma boninense) in oil palm plantations.

PubMed

Susanto, A; Sudharto, P S; Purba, R Y

2005-01-01

Basal Stem Rot (BSR) disease caused by Ganoderma boninense is the most destructive disease in oil palm, especially in Indonesia and Malaysia. The available control measures for BSR disease such as cultural practices and mechanical and chemical treatment have not proved satisfactory due to the fact that Ganoderma has various resting stages such as melanised mycelium, basidiospores and pseudosclerotia. Alternative control measures to overcome the Ganoderma problem are focused on the use of biological control agents and planting resistant material. Present studies conducted at Indonesian Oil Palm Research Institute (IOPRI) are focused on enhancing the use of biological control agents for Ganoderma. These activities include screening biological agents from the oil palm rhizosphere in order to evaluate their effectiveness as biological agents in glasshouse and field trials, testing their antagonistic activities in large scale experiments and eradicating potential disease inoculum with biological agents. Several promising biological agents have been isolated, mainly Trichoderma harzianum, T. viride, Gliocladium viride, Pseudomonas fluorescens, and Bacillus sp. A glasshouse and field trial for Ganoderma control indicated that treatment with T. harzianum and G. viride was superior to Bacillus sp. A large scale trial showed that the disease incidence was lower in a field treated with biological agents than in untreated fields. In a short term programme, research activities at IOPRI are currently focusing on selecting fungi that can completely degrade plant material in order to eradicate inoculum. Digging holes around the palm bole and adding empty fruit bunches have been investigated as ways to stimulate biological agents.

Spectroscopic Results from the Life in the Atacama (LITA) Project 2004 Field Season

NASA Technical Reports Server (NTRS)

Piatek, J. L.; Moersch, J. E.; Wyatt, M.; Rampey, M.; Cabrol, N. A.; Wettergreen, D. S.; Whittaker, R.; Grin, E. A.; Diaz, G. Chong

2005-01-01

Introduction: The Life in the Atacama (LITA) project includes rover field tests designed to look for life in the arid environment of the Atacama Desert (Chile). Field instruments were chosen to help remote observers identify potential habitats and the presence of life in these habitats, and included two spectrometers for help in identifying the mineralogy of the field sites. Two field trials were undertaken during the 2004 field season. The remote science team had no prior knowledge of the local geology, and relied entirely on orbital images and rover-acquired data to make interpretations. Each field trial lasted approximately one week: the sites for these trials were in different locations, and are designated "Site B" and "Site C."

Evaluating the importance of sham controlled trials in the investigation of medical devices in interventional cardiology.

PubMed

Byrne, Robert A; Capodanno, Davide; Mahfoud, Felix; Fajadet, Jean; Windecker, Stephan; Jüni, Peter; Baumbach, Andreas; Wijns, William; Haude, Michael

2018-05-22

Cardiovascular medicine is one of the specialties that has relied most heavily on evidence from randomized clinical trials in determining best practice for the management of common disease conditions. When comparing treatment approaches, trials incorporating random allocation are the most appropriate method for protecting against treatment allocation bias. In order to protect against performance and ascertainment bias, trial designs including placebo control are preferable where feasible. In contrast to testing of medicines, treatments based on procedures or use of medical devices are more challenging to assess, as sham procedures are necessary to facilitate blinding of participants. However, in many cases, ethical concerns exist, as individual patients allocated to sham procedure are exposed only to risk without potential for benefit. Accordingly, the potential benefits to the general patient population must be carefully weighed against the risks of the exposed individuals. For this reason, trial design and study conduct are critically important to ensure that the investigation has the best chance of answering the study question at hand. In the current manuscript, we aim to review issues relating to the conduct of sham-controlled trials and discuss a number of recent examples in the field of interventional cardiology.

Trial Registration at ClinicalTrials.gov between May and October 2005

PubMed Central

Zarin, Deborah A.; Tse, Tony; Ide, Nicholas C.

2006-01-01

BACKGROUND Clinical trial registration allows interested parties to obtain information about ongoing and completed trials, but there are few data indicating the quality of the information provided during the registration process. We used information in the publicly available ClinicalTrials.gov database to describe patterns of trial registration before and after the implementation by journal editors of a new policy requiring registration as a prerequisite for publication. METHODS We reviewed ClinicalTrials.gov records to determine patterns of completion of the “Intervention Name” and “Primary Outcome Measure” data fields for trials registered on May 20 and October 11, 2005, and for trials registered during the interval between these two dates, inclusively. RESULTS During the interval studied, the number of registrations in ClinicalTrials.gov increased by 73 percent from 13,153 to 22,714. The percentage of interventional trials registered by industry with nonspecific Intervention Name entries (attributable to four drug companies) decreased from 10 percent to 2 percent; all other industry and nonindustry records contained specific entries in this field. Of the 2670 studies registered by industry between the two dates, 76 percent provided information in the Primary Outcome Measure field, although these entries varied markedly in their degree of specificity. In the remaining 24 percent of the records, this field was blank. CONCLUSIONS During the summer of 2005, there were large increases in the number of clinical trial registrations. Overall, the data contained in records were more complete in October than they were in May, but there still is room for substantial improvement. PMID:16382064

Genetic progress in homogeneous regions of wheat cultivation in Rio Grande do Sul State, Brazil.

PubMed

Follmann, D N; Cargnelutti Filho, A; Lúcio, A D; de Souza, V Q; Caraffa, M; Wartha, C A

2017-03-30

The State of Rio Grande do Sul (RS) stands out as the largest wheat producer in Brazil. Wheat is the most emphasized winter cereal in RS, attracting public and private investments directed to wheat genetic breeding. The study of genetic progress should be performed routinely at breeding programs to study the behavior of cultivars developed for homogeneous regions of cultivation. The objectives of this study were: 1) to evaluate the genetic progress of wheat grain yield in RS; 2) to evaluate the influence of cultivar competition trial stratification in homogeneous regions of cultivation on the study of genetic progress. Grain yield data of 122 wheat cultivars evaluated in 137 trials arranged in randomized block design with three or four replications were used. Field trials were carried out in 23 locations in RS divided into two homogeneous regions during the period from 2002 to 2013. Genetic progress for RS and homogeneous regions was studied utilizing the method proposed by Vencovsky. Annual genetic progress for wheat grain yield during the period of 12 years in the State of RS was 2.86%, oscillating between homogeneous regions of cultivation. The difference of annual genetic progress in region 1 (1.82%) in relation to region 2 (4.38%) justifies the study of genetic progress by homogeneous regions of cultivation.

Systematic Evaluation of Promising Clinical Trials-Gene Silencing for the Treatment of Glioblastoma.

PubMed

Karaarslan, Numan; Yilmaz, Ibrahim; Ozbek, Hanefi; Caliskan, Tezcan; Topuk, Savas; Sirin, Duygu Yasar; Ates, Ozkan

2018-04-06

The aim of this study was to systematically investigate the role of artificial small interfering RNA (siRNA) molecules in glioblastoma treatment and to give a detailed overview of the literature concerning studies performed in this field worldwide in the last 31 years. Articles about clinical trials conducted between December 1, 1949 and November 8, 2017, were identified from the Cochrane Collaboration, the Cochrane Library, Ovid MEDLINE, ProQuest, the National Library of Medicine, and PubMed electronic databases, using the terms "post transcriptional gene silencing," "small interfering RNA," "siRNA," and "glioblastoma," either individually or combined (\\"OR\\" and \\"AND"), without language and country restrictions. Articles that met the examination criteria were included in the study. After descriptive statistical evaluation, the results were reported in frequency (%). After scanning 2.752 articles, five articles were found that met the research criteria. Examination of full texts of the five identified articles provided no sufficient evidence for research conducted with regard to the use of gene silencing via siRNAs in glioblastoma treatment. To be able to evaluate the clinical use of siRNAs, there is an urgent need for in-vivo studies and for trials with randomized, controlled, and clinical designs that provide long-term functional outcomes.

The effects of low-intensity pulsed ultrasound and pulsed electromagnetic fields bone growth stimulation in acute fractures: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Hannemann, P F W; Mommers, E H H; Schots, J P M; Brink, P R G; Poeze, M

2014-08-01

The aim of this systematic review and meta-analysis was to evaluate the best currently available evidence from randomized controlled trials comparing pulsed electromagnetic fields (PEMF) or low-intensity pulsed ultrasound (LIPUS) bone growth stimulation with placebo for acute fractures. We performed a systematic literature search of the medical literature from 1980 to 2013 for randomized clinical trials concerning acute fractures in adults treated with PEMF or LIPUS. Two reviewers independently determined the strength of the included studies by assessing the risk of bias according to the criteria in the Cochrane Handbook for Systematic Reviews of Interventions. Seven hundred and thirty-seven patients from 13 trials were included. Pooled results from 13 trials reporting proportion of nonunion showed no significant difference between PEMF or LIPUS and control. With regard to time to radiological union, we found heterogeneous results that significantly favoured PEMF or LIPUS bone growth stimulation only in non-operatively treated fractures or fractures of the upper limb. Furthermore, we found significant results that suggest that the use of PEMF or LIPUS in acute diaphyseal fractures may accelerate the time to clinical union. Current evidence from randomized trials is insufficient to conclude a benefit of PEMF or LIPUS bone growth stimulation in reducing the incidence of nonunions when used for treatment in acute fractures. However, our systematic review and meta-analysis suggest that PEMF or LIPUS can be beneficial in the treatment of acute fractures regarding time to radiological and clinical union. PEMF and LIPUS significantly shorten time to radiological union for acute fractures undergoing non-operative treatment and acute fractures of the upper limb. Furthermore, PEMF or LIPUS bone growth stimulation accelerates the time to clinical union for acute diaphyseal fractures.

Biomarkers and surrogate endpoints in kidney disease.

PubMed

Hartung, Erum A

2016-03-01

Kidney disease and its related comorbidities impose a large public health burden. Despite this, the number of clinical trials in nephrology lags behind many other fields. An important factor contributing to the relatively slow pace of nephrology trials is that existing clinical endpoints have significant limitations. "Hard" endpoints for chronic kidney disease, such as progression to end-stage renal disease, may not be reached for decades. Traditional biomarkers, such as serum creatinine in acute kidney injury, may lack sensitivity and predictive value. Finding new biomarkers to serve as surrogate endpoints is therefore an important priority in kidney disease research and may help to accelerate nephrology clinical trials. In this paper, I first review key concepts related to the selection of clinical trial endpoints and discuss statistical and regulatory considerations related to the evaluation of biomarkers as surrogate endpoints. This is followed by a discussion of the challenges and opportunities in developing novel biomarkers and surrogate endpoints in three major areas of nephrology research: acute kidney injury, chronic kidney disease, and autosomal dominant polycystic kidney disease.

Effectiveness of Treatment Approaches for Children and Adolescents with Reading Disabilities: A Meta-Analysis of Randomized Controlled Trials

PubMed Central

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, research should intensify the application of blinded randomized controlled trials. PMID:24587110

The efficacy of a movement control exercise programme to reduce injuries in youth rugby: a cluster randomised controlled trial

PubMed Central

Hislop, M D; Stokes, K A; Williams, S; McKay, C D; England, M; Kemp, S P T

2016-01-01

Background Injuries to youth rugby players have become an increasingly prominent health concern, highlighting the importance of developing and implementing appropriate preventive strategies. A growing body of evidence from other youth sports has demonstrated the efficacy of targeted exercise regimens to reduce injury risk. However, studies have yet to investigate the effect of such interventions in youth contact sport populations like rugby union. Objective To determine the efficacy of an evidence-based movement control exercise programme compared with a sham exercise programme to reduce injury risk in youth rugby players. Exercise programme compliance between trial arms and the effect of coach attitudes on compliance will also be evaluated. Setting School rugby coaches in England will be the target of the researcher intervention, with the effects of the injury prevention programmes being measured in male youth players aged 14–18 years in school rugby programmes over the 2015–2016 school winter term. Methods A cluster-randomised controlled trial with schools randomly allocated to either a movement control exercise programme or a sham exercise programme, both of which are coach-delivered. Injury measures will derive from field-based injury surveillance, with match and training exposure and compliance recorded. A questionnaire will be used to evaluate coach attitudes, knowledge, beliefs and behaviours both prior to and on the conclusion of the study period. Outcome measures Summary injury measures (incidence, severity and burden) will be compared between trial arms, as will the influence of coach attitudes on compliance and injury burden. Additionally, changes in these outcomes through using the exercise programmes will be evaluated. Trial registration number ISRTCNN13422001. PMID:27900148

Methodological reporting quality of randomized controlled trials: A survey of seven core journals of orthopaedics from Mainland China over 5 years following the CONSORT statement.

PubMed

Zhang, J; Chen, X; Zhu, Q; Cui, J; Cao, L; Su, J

2016-11-01

In recent years, the number of randomized controlled trials (RCTs) in the field of orthopaedics is increasing in Mainland China. However, randomized controlled trials (RCTs) are inclined to bias if they lack methodological quality. Therefore, we performed a survey of RCT to assess: (1) What about the quality of RCTs in the field of orthopedics in Mainland China? (2) Whether there is difference between the core journals of the Chinese department of orthopedics and Orthopaedics Traumatology Surgery & Research (OTSR). This research aimed to evaluate the methodological reporting quality according to the CONSORT statement of randomized controlled trials (RCTs) in seven key orthopaedic journals published in Mainland China over 5 years from 2010 to 2014. All of the articles were hand researched on Chongqing VIP database between 2010 and 2014. Studies were considered eligible if the words "random", "randomly", "randomization", "randomized" were employed to describe the allocation way. Trials including animals, cadavers, trials published as abstracts and case report, trials dealing with subgroups analysis, or trials without the outcomes were excluded. In addition, eight articles selected from Orthopaedics Traumatology Surgery & Research (OTSR) between 2010 and 2014 were included in this study for comparison. The identified RCTs are analyzed using a modified version of the Consolidated Standards of Reporting Trials (CONSORT), including the sample size calculation, allocation sequence generation, allocation concealment, blinding and handling of dropouts. A total of 222 RCTs were identified in seven core orthopaedic journals. No trials reported adequate sample size calculation, 74 (33.4%) reported adequate allocation generation, 8 (3.7%) trials reported adequate allocation concealment, 18 (8.1%) trials reported adequate blinding and 16 (7.2%) trials reported handling of dropouts. In OTSR, 1 (12.5%) trial reported adequate sample size calculation, 4 (50.0%) reported adequate allocation generation, 1 (12.5%) trials reported adequate allocation concealment, 2 (25.0%) trials reported adequate blinding and 5 (62.5%) trials reported handling of dropouts. There were statistical differences as for sample size calculation and handling of dropouts between papers from Mainland China and OTSR (P<0.05). The findings of this study show that the methodological reporting quality of RCTs in seven core orthopaedic journals from the Mainland China is far from satisfaction and it needs to further improve to keep up with the standards of the CONSORT statement. Level III case control. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

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.

Canadian MSAT field trial program user requirements

NASA Astrophysics Data System (ADS)

Pedersen, Allister

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.

77 FR 40322 - Oral Rabies Vaccine Trial; Availability of an Environmental Assessment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-09

...] Oral Rabies Vaccine Trial; Availability of an Environmental Assessment AGENCY: Animal and Plant Health... assessment relative to an oral rabies vaccination field trial in New Hampshire, New York, Ohio, Vermont, and West Virginia. The environmental assessment analyzes the use of an experimental rabies vaccine in field...

Asian Americans and Cancer Clinical Trials: A Mixed-Methods Approach to Understanding Awareness and Experience

PubMed Central

Paterniti, Debora A.; Chen, Moon S.; Chiechi, Christine; Beckett, Laurel A.; Horan, Nora; Turrell, Corinne; Smith, Ligaya; Morain, Claudia; Montell, Lisa; Gonzalez, Jose Luis; Davis, Sharon; Lara, Primo N.

2006-01-01

Cancer clinical trials have been based on low accrual rates. Barriers to recruitment of minority populations affect the generalizability and impact of trial findings for those populations. The authors undertook a mixed-methods approach to understanding levels of awareness and experiences with cancer clinical trials. A survey was administered to new cancer patients and their caretakers (family, close friends, or other social support) at outpatient oncology clinics. Field observations of the trial accrual process also were conducted by employing the grounded theory approach in qualitative methods. Comparison of survey results for Asian-American respondents and non-Asian respondents indicated that Asians were less likely to have heard the term “clinical trial” and were more likely to define a clinical trial as “an experiment” or “a test procedure in a clinic” than non-Asians. Asians were more likely to have employer-based insurance and to report understanding issues related to cost reimbursement. Asians were less likely to have been involved in or to know someone in a trial and reported less willingness than white respondents to consider trial participation. Qualitative observations suggested that Asians who presented for a potential trial were interested in the availability of a novel cancer therapy but were not eligible for available trials. Multiple strategies will be necessary to enhance awareness of and experience with accrual to cancer clinical trials for Asians, including richer understanding and increased involvement of Asians in cancer clinical trials and greater attention to the location and diversity of the Asian population in structuring study centers and evaluating trial results. PMID:16247795

Tilmicosin as a single injection treatment for respiratory disease of feedlot cattle

PubMed Central

Gorham, Paul E.; Carroll, Lamar H.; McAskill, Jack W.; Watkins, Lee E.; Ose, Earl E.; Tonkinson, Lealon V.; Merrill, John K.

1990-01-01

Tilmicosin, a new semi-synthetic macrolide antibiotic, was evaluated in eight field trials as a single subcutaneous injection at dosages of 0 (placebo), 5, 10 and 20 mg/kg for the treatment of naturally occurring respiratory disease in feedlot cattle. Animals for these trials were selected from large groups of recently-shipped feeder cattle at the time clinical signs of respiratory disease and body temperature of 40.6°C or higher were observed. Treated animals were evaluated daily for 10 days and finally at day 28. Each animal was weighed on the first day and again on day 28. Animals that died were necropsied. All treatment dosages were effective in significantly lowering mortality, improving weight gains, lowering body temperature, and reducing the severity of clinical signs when compared to the placebo-treated controls. Body temperature was the only variable with statistically significant differences among the dose levels. PMID:17423706

Recruitment to publicly funded trials--are surgical trials really different?

PubMed

Cook, Jonathan A; Ramsay, Craig R; Norrie, John

2008-09-01

Good recruitment is integral to the conduct of a high-quality randomised controlled trial. It has been suggested that recruitment is particularly difficult for evaluations of surgical interventions, a field in which there is a dearth of evidence from randomised comparisons. While there is anecdotal speculation to support the inference that recruitment to surgical trials is more challenging than for medical trials we are unaware of any formal assessment of this. In this paper, we compare recruitment to surgical and medical trials using a cohort of publicly funded trials. Overall recruitment to trials was assessed using of a cohort of publicly funded trials (n=114). Comparisons were made by using the Recruitment Index, a simple measure of recruitment activity for multicentre randomised controlled trials. Recruitment at the centre level was also investigated through three example surgical trials. The Recruitment Index was found to be higher, though not statistically significantly, in the surgical group (n=18, median=38.0 IQR (10.7, 77.4)) versus (n=81, median=34.8 IQR (11.7, 98.0)) days per recruit for the medical group (median difference 1.7 (-19.2, 25.1); p=0.828). For the trials where the comparison was between a surgical and a medical intervention, the Recruitment Index was substantially higher (n=6, 68.3 (23.5, 294.8)) versus (n=93, 34.6 (11.7, 90.0); median difference 25.9 (-35.5, 221.8); p=0.291) for the other trials. There was no clear evidence that surgical trials differ from medical trials in terms of recruitment activity. There was, however, support for the inference that medical versus surgical trials are more difficult to recruit to. Formal exploration of the recruitment data through a modelling approach may go some way to tease out where important differences exist.

A cross-sectional analysis of HIV and hepatitis C clinical trials 2007 to 2010: the relationship between industry sponsorship and randomized study design.

PubMed

Goswami, Neela D; Tsalik, Ephraim L; Naggie, Susanna; Miller, William C; Horton, John R; Pfeiffer, Christopher D; Hicks, Charles B

2014-01-22

The proportion of clinical research sponsored by industry will likely continue to expand as federal funds for academic research decreases, particularly in the fields of HIV/AIDS and hepatitis C (HCV). While HIV and HCV continue to burden the US population, insufficient data exists as to how industry sponsorship affects clinical trials involving these infectious diseases. Debate exists about whether pharmaceutical companies undertake more market-driven research practices to promote therapeutics, or instead conduct more rigorous trials than their non-industry counterparts because of increased resources and scrutiny. The ClinicalTrials.gov registry, which allows investigators to fulfill a federal mandate for public trial registration, provides an opportunity for critical evaluation of study designs for industry-sponsored trials, independent of publication status. As part of a large public policy effort, the Clinical Trials Transformation Initiative (CTTI) recently transformed the ClinicalTrials.gov registry into a searchable dataset to facilitate research on clinical trials themselves. We conducted a cross-sectional analysis of 477 HIV and HCV drug treatment trials, registered with ClinicalTrials.gov from 1 October 2007 to 27 September 2010, to study the relationship of study sponsorship with randomized study design. The likelihood of using randomization given industry (versus non-industry) sponsorship was reported with prevalence ratios (PR). PRs were estimated using crude and stratified tabular analysis and Poisson regression adjusting for presence of a data monitoring committee, enrollment size, study phase, number of study sites, inclusion of foreign study sites, exclusion of persons older than age 65, and disease condition. The crude PR was 1.17 (95% CI 0.94, 1.45). Adjusted Poisson models produced a PR of 1.13 (95% CI 0.82, 1.56). There was a trend toward mild effect measure modification by study phase, but this was not statistically significant. In stratified tabular analysis the adjusted PR was 1.14 (95% CI 0.78, 1.68) among phase 2/3 trials and 1.06 (95% CI 0.50, 2.22) among phase 4 trials. No significant relationship was found between industry sponsorship and use of randomization in trial design in this cross-sectional study. Prospective studies evaluating other aspects of trial design may shed further light on the relationship between industry sponsorship and appropriate trial methodology.

A cross-sectional analysis of HIV and hepatitis C clinical trials 2007 to 2010: the relationship between industry sponsorship and randomized study design

PubMed Central

2014-01-01

Background The proportion of clinical research sponsored by industry will likely continue to expand as federal funds for academic research decreases, particularly in the fields of HIV/AIDS and hepatitis C (HCV). While HIV and HCV continue to burden the US population, insufficient data exists as to how industry sponsorship affects clinical trials involving these infectious diseases. Debate exists about whether pharmaceutical companies undertake more market-driven research practices to promote therapeutics, or instead conduct more rigorous trials than their non-industry counterparts because of increased resources and scrutiny. The ClinicalTrials.gov registry, which allows investigators to fulfill a federal mandate for public trial registration, provides an opportunity for critical evaluation of study designs for industry-sponsored trials, independent of publication status. As part of a large public policy effort, the Clinical Trials Transformation Initiative (CTTI) recently transformed the ClinicalTrials.gov registry into a searchable dataset to facilitate research on clinical trials themselves. Methods We conducted a cross-sectional analysis of 477 HIV and HCV drug treatment trials, registered with ClinicalTrials.gov from 1 October 2007 to 27 September 2010, to study the relationship of study sponsorship with randomized study design. The likelihood of using randomization given industry (versus non-industry) sponsorship was reported with prevalence ratios (PR). PRs were estimated using crude and stratified tabular analysis and Poisson regression adjusting for presence of a data monitoring committee, enrollment size, study phase, number of study sites, inclusion of foreign study sites, exclusion of persons older than age 65, and disease condition. Results The crude PR was 1.17 (95% CI 0.94, 1.45). Adjusted Poisson models produced a PR of 1.13 (95% CI 0.82, 1.56). There was a trend toward mild effect measure modification by study phase, but this was not statistically significant. In stratified tabular analysis the adjusted PR was 1.14 (95% CI 0.78, 1.68) among phase 2/3 trials and 1.06 (95% CI 0.50, 2.22) among phase 4 trials. Conclusions No significant relationship was found between industry sponsorship and use of randomization in trial design in this cross-sectional study. Prospective studies evaluating other aspects of trial design may shed further light on the relationship between industry sponsorship and appropriate trial methodology. PMID:24450313

Professional Acceptance Of Electronic Images In Radiologic Practice

NASA Astrophysics Data System (ADS)

Gitlin, Joseph N.; Curtis, David J.; Kerlin, Barbara D.; Olmsted, William W.

1983-05-01

During the past four years, a large number of radiographic images have been interpreted in both film and video modes in an effort to determine the utility of digital/analogue systems in general practice. With the cooperation of the Department of Defense, the MITRE Corporation, and several university-based radiology departments, the Public Health Service has participated in laboratory experiments and a teleradiology field trial to meet this objective. During the field trial, 30 radiologists participated in the interpretation of more than 4,000 diagnostic x-ray examinations that were performed at distant clinics, digitized, and transmitted to a medical center for interpretation on video monitors. As part of the evaluation, all of the participating radiologists and the attending physicians at the clinics were queried regarding the teleradiology system, particularly with respect to the diagnostic quality of the electronic images. The original films for each of the 4,000 examinations were read independently, and the findings and impressions from each mode were compared to identify discrepancies. In addition, a sample of 530 cases was reviewed and interpreted by a consensus panel to measure the accuracy of findings and impressions of both film and video readings. The sample has been retained in an automated archive for future study at the National Center of Devices and Radiological Health facilities in Rockville, Maryland. The studies include a comparison of diagnostic findings and impressions from 1024 x 1024 matrices with those obtained from the 512 x 512 format used in the field trial. The archive also provides a database for determining the effect of data compression techniques on diagnostic interpretations and establishing the utility of image processing algorithms. The paper will include an analysis of the final results of the field trial and preliminary findings from the ongoing studies using the archive of cases at the National Center for Devices and Radiological Health. This paper was not available at the time of printing of the Proceedings.

Field trials of solid triple lure (trimedlure, methyl eugenol, raspberry ketone, and DDVP) dispensers for detection and male annihilation of Ceratitis capitata (Wiedemann), Bactrocera dorsalis (Hendel) and Bactrocera cucurbit

USDA-ARS?s Scientific Manuscript database

Solid Mallet TMR (trimedlure [TML], methyl eugenol [ME], raspberry ketone [RK]) wafers and Mallet CMR (ceralure, ME, RK, benzyl acetate) wafers impregnated with DDVP insecticide were evaluated in traps as potential detection and male annihilation devices. Comparisons were made with 1) liquid lure a...

[Patients' perspective and economic variables as objectives in clinical trials: added value to clinical parameters].

PubMed

Bovaira-García, M J; Soler-Company, E

2012-01-01

Patient-reported outcome (PRO) measures complement traditional biomedical outcome measures. The purpose of this study was to evaluate the use of PRO measures including health-related quality of life (HRQoL) questionnaires as a measurement of efficacy and the frequency of inclusion of economic variables related to direct and indirect costs in the design of clinical trials and phase IV observational studies. Moreover, for the trials quality score were measured, and if there were any relationship between the quality study design score and the PRO inclusion. Retrospective observational study of the clinical trials and phase IV observational studies approved by a Clinical Research Ethics Committee (2008-2010). We gathered data concerning general aspects including medical specialty, pathology, methodological quality based on Jadad scale (0-5), inclusion of PRO and economic variables. For clinical trials including HRQoL measurements, we analysed the type of questionnaire in use. Where there were no HRQoL measurements, we analysed if their inclusion would have been proper or not. A total of 70 protocols (59 CTs and 11 phase IV observational studies) were analysed; 37 (52.8%) included PRO measures, and 3 protocols (4.3%) used them as a primary endpoint. Data analysis by therapeutic area showed that PRO measures were most commonly studied in the fields of endocrinology, neurology, digestive diseases, and cardiology. The average quality score for the trials was 2.8. The trials with more PRO inclusion in their end points had a significantly higher quality score. Only 13 (22%) clinical trials and 2 (18.2%) phase IV observational studies included economic variables. The emergence of economic variables in clinical trials and phase IV observational studies evaluated was low, however, more than half of the revised protocols have included PRO measures, reflecting the importance of these parameters in the assessment of the effectiveness of drug treatments, although its use is still not systematic. Copyright © 2011 SECA. Published by Elsevier Espana. All rights reserved.

Current challenges and future perspectives of plant and agricultural biotechnology.

PubMed

Moshelion, Menachem; Altman, Arie

2015-06-01

Advances in understanding plant biology, novel genetic resources, genome modification, and omics technologies generate new solutions for food security and novel biomaterials production under changing environmental conditions. New gene and germplasm candidates that are anticipated to lead to improved crop yields and other plant traits under stress have to pass long development phases based on trial and error using large-scale field evaluation. Therefore, quantitative, objective, and automated screening methods combined with decision-making algorithms are likely to have many advantages, enabling rapid screening of the most promising crop lines at an early stage followed by final mandatory field experiments. The combination of novel molecular tools, screening technologies, and economic evaluation should become the main goal of the plant biotechnological revolution in agriculture. Copyright © 2015 Elsevier Ltd. All rights reserved.

Field evaluation and user acceptability of repellent formulations containing DEET against mosquitoes in Australia.

PubMed

Frances, Stephen P

2013-09-01

Field efficacy trials comparing 2 formulations of deet against mosquitoes in Redcliffe, Queensland, Australia were conducted in February 2009. A formulation containing 35% deet in a gel (Australian Defence Force deet) provided > 95% protection for 3 h, while a formulation containing 40% deet in ethanol (Bushman) in a spray applicator provided > 95% for 6 h. A user acceptability study showed that 82% of soldiers using the Bushman formulation during contingency operations for 14-28 days in Timor-Leste would recommend this formulation to others and believed that the formulation provided protection against mosquitoes.

The research gap in chronic paediatric pain: A systematic review of randomised controlled trials.

PubMed

Boulkedid, R; Abdou, A Y; Desselas, E; Monégat, M; de Leeuw, T G; Avez-Couturier, J; Dugue, S; Mareau, C; Charron, B; Alberti, C; Kaguelidou, F

2018-02-01

Chronic pain is associated with significant functional and social impairment. The objective of this review was to assess the characteristics and quality of randomized controlled trials (RCTs) evaluating pain management interventions in children and adolescents with chronic pain. We performed a systematic search of PubMed, Embase and the Cochrane Library up to July 2017. We included RCTs that involved children and adolescents (3 months-18 years) and evaluated the use of pharmacological or non-pharmacological intervention(s) in the context of pain persisting or re-occurring for more than 3 months. Methodological quality was evaluated using the Cochrane Risk of Bias (ROB) Tool. A total of 58 RCTs were identified and numbers steadily increased over time. The majority were conducted in single hospital institutions, with no information on study funding. Median sample size was 47.5 participants (Q1,Q3: 32, 70). Forty-five percent of RCTs included both adults and children and the median of the mean ages at inclusion was 12.9 years (Q1,Q3: 11, 15). Testing of non-pharmacological interventions was predominant and only 5 RCTs evaluated analgesics or co-analgesics. Abdominal pain, headache/migraine and musculoskeletal pain were the most common types of chronic pain among participants. Methodological quality was poor with 90% of RCTs presenting a high or unclear ROB. Evaluation of analgesics targeting chronic pain relief in children and adolescents through RCTs is marginal. Infants and children with long-lasting painful conditions are insufficiently represented in RCTs. We discuss possible research constraints and challenges as well as methodologies to circumvent them. There is a substantial research gap regarding analgesic interventions for children and adolescents with chronic pain. Most clinical trials in the field focus on the evaluation of non-pharmacological interventions and are of low methodological quality. There is also a specific lack of trials involving infants and children and adolescents with long-lasting diseases. © 2017 European Pain Federation - EFIC®.

Predicting High-Power Performance in Professional Cyclists.

PubMed

Sanders, Dajo; Heijboer, Mathieu; Akubat, Ibrahim; Meijer, Kenneth; Hesselink, Matthijs K

2017-03-01

To assess if short-duration (5 to ~300 s) high-power performance can accurately be predicted using the anaerobic power reserve (APR) model in professional cyclists. Data from 4 professional cyclists from a World Tour cycling team were used. Using the maximal aerobic power, sprint peak power output, and an exponential constant describing the decrement in power over time, a power-duration relationship was established for each participant. To test the predictive accuracy of the model, several all-out field trials of different durations were performed by each cyclist. The power output achieved during the all-out trials was compared with the predicted power output by the APR model. The power output predicted by the model showed very large to nearly perfect correlations to the actual power output obtained during the all-out trials for each cyclist (r = .88 ± .21, .92 ± .17, .95 ± .13, and .97 ± .09). Power output during the all-out trials remained within an average of 6.6% (53 W) of the predicted power output by the model. This preliminary pilot study presents 4 case studies on the applicability of the APR model in professional cyclists using a field-based approach. The decrement in all-out performance during high-intensity exercise seems to conform to a general relationship with a single exponential-decay model describing the decrement in power vs increasing duration. These results are in line with previous studies using the APR model to predict performance during brief all-out trials. Future research should evaluate the APR model with a larger sample size of elite cyclists.

Experience and challenges from clinical trials with malaria vaccines in Africa

PubMed Central

2013-01-01

Malaria vaccines are considered amongst the most important modalities for potential elimination of malaria disease and transmission. Research and development in this field has been an area of intense effort by many groups over the last few decades. Despite this, there is currently no licensed malaria vaccine. Researchers, clinical trialists and vaccine developers have been working on many approached to make malaria vaccine available. African research institutions have developed and demonstrated a great capacity to undertake clinical trials in accordance to the International Conference on Harmonization-Good Clinical Practice (ICH-GCP) standards in the last decade; particularly in the field of malaria vaccines and anti-malarial drugs. This capacity is a result of networking among African scientists in collaboration with other partners; this has traversed both clinical trials and malaria control programmes as part of the Global Malaria Action Plan (GMAP). GMAP outlined and support global strategies toward the elimination and eradication of malaria in many areas, translating in reduction in public health burden, especially for African children. In the sub-Saharan region the capacity to undertake more clinical trials remains small in comparison to the actual need. However, sustainability of the already developed capacity is essential and crucial for the evaluation of different interventions and diagnostic tools/strategies for other diseases like TB, HIV, neglected tropical diseases and non-communicable diseases. There is urgent need for innovative mechanisms for the sustainability and expansion of the capacity in clinical trials in sub-Saharan Africa as the catalyst for health improvement and maintained. PMID:23496910

Method matters: Understanding diagnostic reliability in DSM-IV and DSM-5.

PubMed

Chmielewski, Michael; Clark, Lee Anna; Bagby, R Michael; Watson, David

2015-08-01

Diagnostic reliability is essential for the science and practice of psychology, in part because reliability is necessary for validity. Recently, the DSM-5 field trials documented lower diagnostic reliability than past field trials and the general research literature, resulting in substantial criticism of the DSM-5 diagnostic criteria. Rather than indicating specific problems with DSM-5, however, the field trials may have revealed long-standing diagnostic issues that have been hidden due to a reliance on audio/video recordings for estimating reliability. We estimated the reliability of DSM-IV diagnoses using both the standard audio-recording method and the test-retest method used in the DSM-5 field trials, in which different clinicians conduct separate interviews. Psychiatric patients (N = 339) were diagnosed using the SCID-I/P; 218 were diagnosed a second time by an independent interviewer. Diagnostic reliability using the audio-recording method (N = 49) was "good" to "excellent" (M κ = .80) and comparable to the DSM-IV field trials estimates. Reliability using the test-retest method (N = 218) was "poor" to "fair" (M κ = .47) and similar to DSM-5 field-trials' estimates. Despite low test-retest diagnostic reliability, self-reported symptoms were highly stable. Moreover, there was no association between change in self-report and change in diagnostic status. These results demonstrate the influence of method on estimates of diagnostic reliability. (c) 2015 APA, all rights reserved).

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.

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

DOE Office of Scientific and Technical Information (OSTI.GOV)

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. Allmore » three exploration techniques located the reservoirs independent of depth, hydrocarbon type, or trapping style.« less

Feasibility and acceptability of the DSM-5 Field Trial procedures in the Johns Hopkins Community Psychiatry Programs†

PubMed Central

Clarke, Diana E.; Wilcox, Holly C.; Miller, Leslie; Cullen, Bernadette; Gerring, Joan; Greiner, Lisa H.; Newcomer, Alison; Mckitty, Mellisha V.; Regier, Darrel A.; Narrow, William E.

2014-01-01

The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) contains criteria for psychiatric diagnoses that reflect advances in the science and conceptualization of mental disorders and address the needs of clinicians. DSM-5 also recommends research on dimensional measures of cross-cutting symptoms and diagnostic severity, which are expected to better capture patients’ experiences with mental disorders. Prior to its May 2013 release, the American Psychiatric Association (APA) conducted field trials to examine the feasibility, clinical utility, reliability, and where possible, the validity of proposed DSM-5 diagnostic criteria and dimensional measures. The methods and measures proposed for the DSM-5 field trials were pilot tested in adult and child/adolescent clinical samples, with the goal to identify and correct design and procedural problems with the proposed methods before resources were expended for the larger DSM-5 Field Trials. Results allowed for the refinement of the protocols, procedures, and measures, which facilitated recruitment, implementation, and completion of the DSM-5 Field Trials. These results highlight the benefits of pilot studies in planning large multisite studies. PMID:24615761

CERES–Maize Model for Determining the Optimum Planting Dates of Early Maturing Maize Varieties in Northern Nigeria

PubMed Central

Adnan, Adnan A.; Jibrin, Jibrin M.; Kamara, Alpha Y.; Abdulrahman, Bassam L.; Shaibu, Abdulwahab S.; Garba, Ismail I.

2017-01-01

Field trials were carried out in the Sudan Savannah of Nigeria to assess the usefulness of CERES–maize crop model as a decision support tool for optimizing maize production through manipulation of plant dates. The calibration experiments comprised of 20 maize varieties planted during the dry and rainy seasons of 2014 and 2015 at Bayero University Kano and Audu Bako College of Agriculture Dambatta. The trials for model evaluation were conducted in 16 different farmer fields across the Sudan (Bunkure and Garun—Mallam) and Northern Guinea (Tudun-Wada and Lere) Savannas using two of the calibrated varieties under four different sowing dates. The model accurately predicted grain yield, harvest index, and biomass of both varieties with low RMSE-values (below 5% of mean), high d-index (above 0.8), and high r-square (above 0.9) for the calibration trials. The time series data (tops weight, stem and leaf dry weights) were also predicted with high accuracy (% RMSEn above 70%, d-index above 0.88). Similar results were also observed for the evaluation trials, where all variables were simulated with high accuracies. Estimation efficiencies (EF)-values above 0.8 were observed for all the evaluation parameters. Seasonal and sensitivity analyses on Typic Plinthiustalfs and Plinthic Kanhaplustults in the Sudan and Northern Guinea Savannas were conducted. Results showed that planting extra early maize varieties in late July and early maize in mid-June leads to production of highest grain yields in the Sudan Savanna. In the Northern Guinea Savanna planting extra-early maize in mid-July and early maize in late July produced the highest grain yields. Delaying planting in both Agro-ecologies until mid-August leads to lower yields. Delaying planting to mid-August led to grain yield reduction of 39.2% for extra early maize and 74.4% for early maize in the Sudan Savanna. In the Northern Guinea Savanna however, delaying planting to mid-August resulted in yield reduction of 66.9 and 94.3% for extra-early and early maize, respectively. PMID:28702039

Field Performance of Bt Eggplants (Solanum melongena L.) in the Philippines: Cry1Ac Expression and Control of the Eggplant Fruit and Shoot Borer (Leucinodes orbonalis Guenée)

PubMed Central

Hautea, Desiree M.; Taylo, Lourdes D.; Masanga, Anna Pauleen L.; Sison, Maria Luz J.; Narciso, Josefina O.; Quilloy, Reynaldo B.; Hautea, Randy A.; Shotkoski, Frank A.; Shelton, Anthony M.

2016-01-01

Plants expressing Cry proteins from the bacterium, Bacillus thuringiensis (Bt), have become a major tactic for controlling insect pests in maize and cotton globally. However, there are few Bt vegetable crops. Eggplant (Solanum melongena) is a popular vegetable grown throughout Asia that is heavily treated with insecticides to control the eggplant fruit and shoot borer, Leucinodes orbonalis (EFSB). Herein we provide the first publicly available data on field performance in Asia of eggplant engineered to produce the Cry1Ac protein. Replicated field trials with five Bt eggplant open-pollinated (OP) lines from transformation event EE-1 and their non-Bt comparators were conducted over three cropping seasons in the Philippines from 2010–2012. Field trials documented levels of Cry1Ac protein expressed in plants and evaluated their efficacy against the primary target pest, EFSB. Cry1Ac concentrations ranged from 0.75–24.7 ppm dry weight with the highest in the terminal leaves (or shoots) and the lowest in the roots. Cry1Ac levels significantly increased from the vegetative to the reproductive stage. Bt eggplant lines demonstrated excellent control of EFSB. Pairwise analysis of means detected highly significant differences between Bt eggplant lines and their non-Bt comparators for all field efficacy parameters tested. Bt eggplant lines demonstrated high levels of control of EFSB shoot damage (98.6–100%) and fruit damage (98.1–99.7%) and reduced EFSB larval infestation (95.8–99.3%) under the most severe pest pressure during trial 2. Moths that emerged from larvae collected from Bt plants in the field and reared in their Bt eggplant hosts did not produce viable eggs or offspring. These results demonstrate that Bt eggplant lines containing Cry1Ac event EE-1 provide outstanding control of EFSB and can dramatically reduce the need for conventional insecticides. PMID:27322533

Toxicity of emamectin benzoate to Cydia pomonella (L.) and Cydia molesta (Busck) (Lepidoptera: Tortricidae): laboratory and field tests.

PubMed

Ioriatti, Claudio; Anfora, Gianfranco; Angeli, Gino; Civolani, Stefano; Schmidt, Silvia; Pasqualini, Edison

2009-03-01

Emamectin benzoate is a novel macrocyclic lactone insecticide derived from naturally occurring avermectin molecules isolated by fermentation from the soil microorganism Streptomyces avermitilis Kim & Goodfellow. The present study aims to evaluate the toxicity of emamectin benzoate to codling moth, Cydia pomonella (L.), and oriental fruit moth, C. molesta (Busck), under laboratory and semi-field conditions. Dose response bioassays showed that emamectin benzoate had a high level of intrinsic toxicity to early-stage larvae of both species, and that contact activity might contribute significantly to mortality. In the semi-field trials, residual toxicity lasted for more than 1 week. Ovicidal activity was recorded only for C. pomonella (approximately 30%), irrespective of the concentrations tested. Field trials confirmed the efficacy of emamectin benzoate on codling moth when applied at 7 day intervals. Fruit damage, both from the first and second generations, was comparable with that on treatment with chlorpyrifos-ethyl, used as a chemical reference. Emamectin benzoate may be considered a valuable tool for the control of codling moth as a component of an IPM programme. Its collective advantages are: high efficacy, lack of cross-resistance with currently used products, control of secondary pests such as oriental fruit moth and selective toxicity that spares beneficials. 2008 Society of Chemical Industry

Theory-based interventions for contraception.

PubMed

Lopez, Laureen M; Tolley, Elizabeth E; Grimes, David A; Chen-Mok, Mario

2009-01-21

The explicit use of theory in research helps expand the knowledge base. Theories and models have been used extensively in HIV-prevention research and in interventions for preventing sexually transmitted infections (STIs). The health behavior field uses many theories or models of change. However, educational interventions addressing contraception often have no stated theoretical base. Review randomized controlled trials that tested a theoretical approach to inform contraceptive choice; encourage contraceptive use; or promote adherence to, or continuation of, a contraceptive regimen. We searched computerized databases for trials that tested a theory-based intervention for improving contraceptive use (MEDLINE, POPLINE, CENTRAL, PsycINFO, EMBASE, ClinicalTrials.gov, and ICTRP). We also wrote to researchers to find other trials. Trials tested a theory-based intervention for improving contraceptive use. We excluded trials focused on high-risk groups. Interventions addressed the use of one or more contraceptive methods. The reports provided evidence that the intervention was based on a specific theory or model. The primary outcomes were pregnancy, contraceptive choice, initiating or changing contraceptive use, contraceptive regimen adherence, and contraception continuation. The primary author evaluated abstracts for eligibility. Two authors extracted data from included studies. We calculated the odds ratio for dichotomous outcomes and the mean difference for continuous data. No meta-analysis was conducted due to intervention differences. Of 26 trials, 12 interventions addressed contraception (other than condoms), while 14 focused on condom use for preventing HIV or STIs. In 2 of 10 trials with pregnancy or birth data, a theory-based group showed better results. Four of nine trials with contraceptive use (other than condoms) showed better outcomes in an experimental group. For condom use, a theory-based group had favorable results in 14 of 20 trials, but the number was halved in a subgroup analysis. Social Cognitive Theory was the main theoretical basis for 12 trials, and 10 showed positive results. Of the other 14 trials, favorable results were shown for other social cognition models (N=2), motivational interviewing (N=5), and the AIDS Risk Reduction Model (N=2). No major patterns were detected by type of theory, intervention, or target population. Family planning researchers and practitioners could apply the relevant theories and effective interventions from HIV and STI prevention. More thorough use of single theories would help inform the field about what works. Better reporting is needed on research design and intervention implementation.

Changes in dicot-weeds species composition in spring barley in Latvia during the past 20 years.

PubMed

Vanaga, I

2012-01-01

Dicot weed populations were assessed in spring barley trials carried out in four three-years periods at 5-year intervals: 1990-1992, 1995-1997; 2001-2003 and 2006-2008. The overall aim of this research was to evaluate the changes in dicot-weed infestations in spring barley in fields of one region (Riga) of Latvia in sod-podzolic loamy sand soil. The results of the trials showed that Galeopsis spp, Stellaoria media, Viola orvensis and Chenopodium album were among the most frequent weed species in the periods of 1990-1992 and 1995-1997. The occurrence of C. album and V. arvensis increased during the periods of 2001-2003 and 2006-2008.

Characteristics of Misdemeanants Treated for Competency Restoration.

PubMed

Gillis, Artha; Holoyda, Brian; Newman, William J; Wilson, Machelle D; Xiong, Glen L

2016-12-01

There are an estimated 60,000 evaluations annually for competence to stand trial for felony indictments and likely more for misdemeanor indictments. Thus, there is an increasing interest in determining factors associated with a defendant's likelihood of being restored to competence to stand trial. Although previous studies have found that a misdemeanor charge predicts significantly less likelihood of restoration of competence when compared with felony charges, states typically allow treatment facilities less time to restore misdemeanor defendants than felony defendants. As there are no studies examining factors associated with restoration of competence to stand trial for misdemeanor defendants, separately from felony defendants, we conducted a retrospective study to examine demographic, clinical, and forensic characteristics associated with restoration of competence to stand trial of misdemeanor defendants. Almost 70 percent of defendants regained competence to stand trial during the study period. When restorable, defendants regained competence in less than three weeks, on average, which addresses a current question in the field regarding time limits for restoration of competence to stand trial. Single marital status and length of stay in the treatment facility during restoration of competence to stand trial were significantly associated with restorability. States may consider such factors when developing and reviewing time limit policies in consideration of the Jackson v. Indiana ruling and when designing interventions aimed at restoring competence to stand trial to misdemeanor defendants in a cost-efficient manner. © 2016 American Academy of Psychiatry and the Law.

Beyond the hype and hope: Critical considerations for intranasal oxytocin research in autism spectrum disorder.

PubMed

Alvares, Gail A; Quintana, Daniel S; Whitehouse, Andrew J O

2017-01-01

Extensive research efforts in the last decade have been expended into understanding whether intranasal oxytocin may be an effective therapeutic in treating social communication impairments in individuals with autism spectrum disorder (ASD). After much hyped early findings, subsequent clinical trials of longer-term administration have yielded more conservative and mixed evidence. However, it is still unclear at this stage whether these more disappointing findings reflect a true null effect or are mitigated by methodological differences masking true effects. In this review, we comprehensively evaluate the rationale for oxytocin as a therapeutic, evaluating evidence from randomized controlled trials, case reports, and open-label studies of oxytocin administration in individuals with ASD. The evidence to date, including reviews of preregistered trials, suggests a number of critical considerations for the design and interpretation of research in this area. These include considering the choice of ASD outcome measures, dosing and nasal spray device issues, and participant selection. Despite these limitations in the field to date, there remains significant potential for oxytocin to ameliorate aspects of the persistent and debilitating social impairments in individuals with ASD. Given the considerable media hype around new treatments for ASD, as well as the needs of eager families, there is an urgent need for researchers to prioritise considering such factors when conducting well-designed and controlled studies to further advance this field. Autism Res 2017, 10: 25-41. © 2016 International Society for Autism Research, Wiley Periodicals, Inc. © 2016 International Society for Autism Research, Wiley Periodicals, Inc.

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

DOE Office of Scientific and Technical Information (OSTI.GOV)

Anderson, Brian J.; Boswell, Ray; Collett, Tim S.

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 wellmore » (“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 uncontrolled destabilization; 2) wells must be carefully designed to enable rapid remediation of well-bore blockages that will occur during any cessation in operations; 3) appropriate gas mixes can be successfully injected into hydrate-bearing reservoirs; 4) sand production can be well-managed through standard engineering controls; 5) reservoir heat exchange during depressurization was much more favorable than expected – mitigating concerns for near-well-bore freezing and enabling consideration of more aggressive pressure reduction and; 6) CO2-CH4 exchange can be accomplished in natural reservoirs. The next steps in evaluation of exchange technology should feature multiple well applications; however such field programs will require extensive preparatory experimental and numerical modeling studies and will likely be a secondary priority to further field testing of production through depressurization.« less

Programmable shunt valve interactions with osseointegrated hearing devices.

PubMed

Pierson, Matthew J; Wehrmann, Daniel; Albers, J Andrew; El Tecle, Najib E; Costa, Dary; Elbabaa, Samer K

2017-04-01

OBJECTIVE Patients with ventriculoperitoneal (VP) shunts with programmable valves who would benefit from osseointegrated hearing devices (OIHDs) represent a unique population. The aim of this study was to evaluate the magnetic field strengths of 4 OIHDs and their interactions with 5 programmable VP shunt valves. METHODS Magnetic field strength was measured as a function of distance for each hearing device (Cochlear Baha 5, Cochlear Baha BP110, Oticon Ponto Plus Power, and Medtronic Sophono) in the following modes: inactive, active in quiet, and active in 60 decibels of background noise in the sound booth. The hearing devices were introduced to each shunt valve (Aesculap proGAV, Aesculap proGAV 2.0, Codman Hakim, Codman Certas, and Medtronic Strata II) also as a function of distance in these identical 3 settings. Each trial was repeated 5 times. Between each trial, the valves were assessed for a change in setting. Finally, using a skull model, the devices were introduced to each other in standard anatomical locations and the valves were assessed for a change in settings. RESULTS The maximum magnetic field strengths generated by the Cochlear Baha 5, BP110, and Oticon OIHDs were 1.1, 36.2, and 48.7 gauss (G), respectively. The maximum strength generated by the Sophono device was > 800 G. The magnetic field strength of the hearing devices decreased markedly with increasing distance from the device. The strength of the Sophono's magnetic attachment decreased to 34.8 G at 5 mm. The Codman Hakim, Codman Certas, and Medtronic Strata II valve settings changed when rotating the valves next to the Sophono abutment. No other changes in valve settings occurred in the distance or anatomical models for any other trials. CONCLUSIONS This is the first study evaluating the interaction between OIHDs and programmable VP shunt valves. The findings suggest that it is safe to use these devices together without having to switch to a nonprogrammable valve or move the shunt valve to a more distant location. Still, care should be taken if the Sophono device is used to ensure that the valve is ≥ 5 mm away from the magnetic attachment.

First-in-Human Trial of a Novel Suprachoroidal Retinal Prosthesis

PubMed Central

Ayton, Lauren N.; Blamey, Peter J.; Guymer, Robyn H.; Luu, Chi D.; Nayagam, David A. X.; Sinclair, Nicholas C.; Shivdasani, Mohit N.; Yeoh, Jonathan; McCombe, Mark F.; Briggs, Robert J.; Opie, Nicholas L.; Villalobos, Joel; Dimitrov, Peter N.; Varsamidis, Mary; Petoe, Matthew A.; McCarthy, Chris D.; Walker, Janine G.; Barnes, Nick; Burkitt, Anthony N.; Williams, Chris E.; Shepherd, Robert K.; Allen, Penelope J.

2014-01-01

Retinal visual prostheses (“bionic eyes”) have the potential to restore vision to blind or profoundly vision-impaired patients. The medical bionic technology used to design, manufacture and implant such prostheses is still in its relative infancy, with various technologies and surgical approaches being evaluated. We hypothesised that a suprachoroidal implant location (between the sclera and choroid of the eye) would provide significant surgical and safety benefits for patients, allowing them to maintain preoperative residual vision as well as gaining prosthetic vision input from the device. This report details the first-in-human Phase 1 trial to investigate the use of retinal implants in the suprachoroidal space in three human subjects with end-stage retinitis pigmentosa. The success of the suprachoroidal surgical approach and its associated safety benefits, coupled with twelve-month post-operative efficacy data, holds promise for the field of vision restoration. Trial Registration Clinicaltrials.gov NCT01603576 PMID:25521292

Implications of ICD-10 for Sarcopenia Clinical Practice and Clinical Trials: Report by the International Conference on Frailty and Sarcopenia Research Task Force.

PubMed

Vellas, B; Fielding, R A; Bens, C; Bernabei, R; Cawthon, P M; Cederholm, T; Cruz-Jentoft, A J; Del Signore, S; Donahue, S; Morley, J; Pahor, M; Reginster, J-Y; Rodriguez Mañas, L; Rolland, Y; Roubenoff, R; Sinclair, A; Cesari, M

2018-01-01

Establishment of an ICD-10-CM code for sarcopenia in 2016 was an important step towards reaching international consensus on the need for a nosological framework of age-related skeletal muscle decline. The International Conference on Frailty and Sarcopenia Research Task Force met in April 2017 to discuss the meaning, significance, and barriers to the implementation of the new code as well as strategies to accelerate development of new therapies. Analyses by the Sarcopenia Definitions and Outcomes Consortium are underway to develop quantitative definitions of sarcopenia. A consensus conference is planned to evaluate this analysis. The Task Force also discussed lessons learned from sarcopenia trials that could be applied to future trials, as well as lessons from the osteoporosis field, a clinical condition with many constructs similar to sarcopenia and for which ad hoc treatments have been developed and approved by regulatory agencies.

An unattended verification station for UF6 cylinders: Field trial findings

NASA Astrophysics Data System (ADS)

Smith, L. E.; Miller, K. A.; McDonald, B. S.; Webster, J. B.; Zalavadia, M. A.; Garner, J. R.; Stewart, S. L.; Branney, S. J.; Todd, L. C.; Deshmukh, N. S.; Nordquist, H. A.; Kulisek, J. A.; Swinhoe, M. T.

2017-12-01

In recent years, the International Atomic Energy Agency (IAEA) has pursued innovative techniques and an integrated suite of safeguards measures to address the verification challenges posed by the front end of the nuclear fuel cycle. Among the unattended instruments currently being explored by the IAEA is an Unattended Cylinder Verification Station (UCVS), which could provide automated, independent verification of the declared relative enrichment, 235U mass, total uranium mass, and identification for all declared uranium hexafluoride cylinders in a facility (e.g., uranium enrichment plants and fuel fabrication plants). Under the auspices of the United States and European Commission Support Programs to the IAEA, a project was undertaken to assess the technical and practical viability of the UCVS concept. The first phase of the UCVS viability study was centered on a long-term field trial of a prototype UCVS system at a fuel fabrication facility. A key outcome of the study was a quantitative performance evaluation of two nondestructive assay (NDA) methods being considered for inclusion in a UCVS: Hybrid Enrichment Verification Array (HEVA), and Passive Neutron Enrichment Meter (PNEM). This paper provides a description of the UCVS prototype design and an overview of the long-term field trial. Analysis results and interpretation are presented with a focus on the performance of PNEM and HEVA for the assay of over 200 "typical" Type 30B cylinders, and the viability of an "NDA Fingerprint" concept as a high-fidelity means to periodically verify that material diversion has not occurred.

Season and application rates affect vaccine bait consumption by prairie dogs in Colorado and Utah, USA

USGS Publications Warehouse

Tripp, Daniel W.; Rocke, Tonie E.; Streich, Sean P.; Brown, Nathanael L.; Fernandez, Julia Rodriguez-Ramos; Miller, Michael W.

2014-01-01

Plague, a zoonotic disease caused by the bacterium Yersinia pestis, causes high rates of mortality in prairie dogs (Cynomys spp.). An oral vaccine against plague has been developed for prairie dogs along with a palatable bait to deliver vaccine and a biomarker to track bait consumption. We conducted field trials between September 2009 and September 2012 to develop recommendations for bait distribution to deliver plague vaccine to prairie dogs. The objectives were to evaluate the use of the biomarker, rhodamine B, in field settings to compare bait distribution strategies, to compare uptake of baits distributed at different densities, to assess seasonal effects on bait uptake, and to measure bait uptake by nontarget small mammal species. Rhodamine B effectively marked prairie dogs' whiskers during these field trials. To compare bait distribution strategies, we applied baits around active burrows or along transects at densities of 32, 65, and 130 baits/ha. Distributing baits at active burrows or by transect did not affect uptake by prairie dogs. Distributing baits at rates of ≥65/ha (or ≥1 bait/active burrow) produced optimal uptake, and bait uptake by prairie dogs in the autumn was superior to uptake in the spring. Six other species of small mammals consumed baits during these trials. All four species of tested prairie dogs readily consumed the baits, demonstrating that vaccine uptake will not be an obstacle to plague control via oral vaccination.

Designing malaria vaccines to circumvent antigen variability.

PubMed

Ouattara, Amed; Barry, Alyssa E; Dutta, Sheetij; Remarque, Edmond J; Beeson, James G; Plowe, Christopher V

2015-12-22

Prospects for malaria eradication will be greatly enhanced by an effective vaccine, but parasite genetic diversity poses a major impediment to malaria vaccine efficacy. In recent pre-clinical and field trials, vaccines based on polymorphic Plasmodium falciparum antigens have shown efficacy only against homologous strains, raising the specter of allele-specific immunity such as that which plagues vaccines against influenza and HIV. The most advanced malaria vaccine, RTS,S, targets relatively conserved epitopes on the P. falciparum circumsporozoite protein. After more than 40 years of development and testing, RTS,S, has shown significant but modest efficacy against clinical malaria in phase 2 and 3 trials. Ongoing phase 2 studies of an irradiated sporozoite vaccine will ascertain whether the full protection against homologous experimental malaria challenge conferred by high doses of a whole organism vaccine can provide protection against diverse strains in the field. Here we review and evaluate approaches being taken to design broadly cross-protective malaria vaccines. Copyright © 2015. Published by Elsevier Ltd.

Effects of midas® on nematodes in commercial floriculture production in Florida.

PubMed

Kokalis-Burelle, Nancy; Rosskopf, Erin N; Albano, Joseph P; Holzinger, John

2010-03-01

Cut flower producers currently have limited options for nematode control. Four field trials were conducted in 2006 and 2007 to evaluate Midas® (iodomethane:chloropicrin 50:50) for control of root-knot nematodes (Meloidogyne arenaria) on Celosia argentea var. cristata in a commercial floriculture production field in southeastern Florida. Midas (224 kg/ha) was compared to methyl bromide:chloropicrin (98:2, 224 kg/ha), and an untreated control. Treatments were evaluated for effects on Meloidogyne arenaria J2 and free-living nematodes in soil through each season, and roots at the end of each season. Plant growth and root disease were also assessed. Population levels of nematodes isolated from soil were highly variable in all trials early in the season, and generally rebounded by harvest, sometimes to higher levels in fumigant treatments than in the untreated control. Although population levels of nematodes in soil were not significantly reduced during the growing season, nematodes in roots and galling at the end of the season were consistently reduced with both methyl bromide and Midas compared to the untreated control. Symptoms of phytotoxicity were observed in Midas treatments during the first year and were attributed to Fe toxicity. Fertilization was adjusted during the second year to investigate potential fumigant/fertilizer interactions. Interactions occurred at the end of the fourth trial between methyl bromide and fertilizers with respect to root-knot nematode J2 isolated from roots and galling. Fewer J2 were isolated from roots treated with a higher level of Fe (3.05%) in the form of Fe sucrate, and galling was reduced in methyl bromide treated plots treated with this fertilizer compared to Fe EDTA. Reduced galling was also seen with Midas in Fe sucrate fertilized plots compared to Fe EDTA. This research demonstrates the difficulty of reducing high root-knot nematode population levels in soil in subtropical conditions in production fields that have been repeatedly fumigated. Although soil population density may remain stable, root population density and disease can be reduced.

Field Trial of Methoxyflurane, Nitrous Oxide, and Trichloroethylene as Obstetric Analgesics

PubMed Central

Rosen, M.; Mushin, W. W.; Jones, P. L.; Jones, E. V.

1969-01-01

In a field trial of 1,257 patients receiving methoxyflurane, trichloroethylene, and nitrous-oxide/oxygen for the relief of pain in labour methoxyflurane has been shown to have certain advantages which support its use in midwifery practice. The trial confirms our objective method for screening an inhalational agent as an obstetric analgesic. PMID:4895340

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.

Systematic evaluation of implementation fidelity of complex interventions in health and social care

PubMed Central

2010-01-01

Background Evaluation of an implementation process and its fidelity can give insight into the 'black box' of interventions. However, a lack of standardized methods for studying fidelity and implementation process have been reported, which might be one reason for the fact that few prior studies in the field of health service research have systematically evaluated interventions' implementation processes. The aim of this project is to systematically evaluate implementation fidelity and possible factors influencing fidelity of complex interventions in health and social care. Methods A modified version of The Conceptual Framework for Implementation Fidelity will be used as a conceptual model for the evaluation. The modification implies two additional moderating factors: context and recruitment. A systematic evaluation process was developed. Multiple case study method is used to investigate implementation of three complex health service interventions. Each case will be investigated in depth and longitudinally, using both quantitative and qualitative methods. Discussion This study is the first attempt to empirically test The Conceptual Framework for Implementation Fidelity. The study can highlight mechanism and factors of importance when implementing complex interventions. Especially the role of the moderating factors on implementation fidelity can be clarified. Trial Registration Supported Employment, SE, among people with severe mental illness -- a randomized controlled trial: NCT00960024. PMID:20815872

Outcomes of a School-Based Intervention (RESCATE) to Improve Physical Activity Patterns in Mexican Children Aged 8-10 Years

ERIC Educational Resources Information Center

Colin-Ramirez, E.; Castillo-Martinez, L.; Orea-Tejeda, A.; Vergara-Castaneda, A.; Keirns-Davis, C.; Villa-Romero, A.

2010-01-01

The aim of this study was to evaluate the impact of an intervention program on the patterns of physical activity in 8- to 10-year-old Mexican children from lower socioeconomic status. This study performed a randomized controlled field trial in 498 children aged 8-10 years from 10 public schools of low socioeconomic status in Mexico City. Schools…

Stokes polarimetry probe for skin lesion evaluation: preliminary results

NASA Astrophysics Data System (ADS)

Louie, Daniel C.; Tchvialeva, Lioudmilla; Kalia, Sunil; Lui, Harvey; Lee, Tim K.

2018-02-01

This paper reports on the design of a prototype in-vivo Stokes polarimetry probe for skin lesion evaluation, and preliminary results from skin phantom and clinical trials of this device. The probe releases a single millisecond-long pulse from a laser diode with either linear or circular polarization. It then captures the resulting backscattered far-field polarization speckle and calculates the Stokes parameters. This probe was designed with three novel innovations in mind. First, the Stokes vector is captured quickly, using low-cost components without the use of moving parts. Second, a compact collimated laser diode was used as the light source. Third, the device and detector geometry were designed to produce and capture a uniform speckle field. In the first clinical trial of this device, measurements were taken from a variety of skin lesions, both cancerous and benign. The Stokes vector was measured and used to calculate the degree of polarization (DOP), the azimuth angle, and the ellipticity angle of the polarization ellipse for two input light polarizations. Among other findings, the DOP for circular polarized input light was consistently lower than the DOP for linear polarized input light. These findings indicate the potential for a fast and low-cost in-vivo skin cancer screening tool, and encourages the continuing development of this probe's techniques.

[Benefit assessment of operative interventions from the perspective of surgical research].

PubMed

Hüttner, F J; Ulrich, A; Mihaljevic, A L; Probst, P; Rossion, I; Diener, Markus K

2015-03-01

The benefit assessment of surgical procedures serves as the basis for the concept of evidence-based surgery. However, especially in the field of surgery, many interventions are lacking assessment in high-quality clinical trials. Therefore, a well-structured benefit assessment of surgical interventions in the future is imperative. Considering the different perspectives, e.g. of the patients, surgeons, industry or health care investors, the implications of the benefits and risks of a procedure can differ significantly. Researchers have to abide by different regulations, depending on the type of intervention being evaluated in a surgical trial. Furthermore, the benefit assessment of surgical procedures poses specific challenges, from the choice of a relevant endpoint to issues concerning the standardization of the interventions and the impact of learning curves. The IDEAL concept, which was established by a group of international experts in 2009, serves as a framework for the future development and assessment of innovations in the field of surgery. For example, the SDGC (Study Center of the German Society of Surgery) and CHIR-Net (Surgical Studies Network) indicate that such collaborations of clinicians and methodologists can lead to the creation of a qualified structure for the effective benefit assessment of surgical procedures. In the future, the aforementioned evidence gaps must be eliminated and innovations evaluated efficiently by the work of such networks.

Integrated ecological risk assessment of pesticides in tropical ecosystems: a case study with carbofuran in Brazil.

PubMed

Chelinho, Sónia; Lopes, Isabel; Natal-da-Luz, Tiago; Domene, Xaxier; Nunes, Maria Edna Tenorio; Espíndola, Evaldo L G; Ribeiro, Rui; Sousa, Jose P

2012-02-01

The aim of the present study is to contribute an ecologically relevant assessment of the ecotoxicological effects of pesticide applications in agricultural areas in the tropics, using an integrated approach with information gathered from soil and aquatic compartments. Carbofuran, an insecticide/nematicide used widely on sugarcane crops, was selected as a model substance. To evaluate the toxic effects of pesticide spraying for soil biota, as well as the potential indirect effects on aquatic biota resulting from surface runoff and/or leaching, field and laboratory (using a cost-effective simulator of pesticide applications) trials were performed. Standard ecotoxicological tests were performed with soil (Eisenia andrei, Folsomia candida, and Enchytraeus crypticus) and aquatic (Ceriodaphnia silvestrii) organisms, using serial dilutions of soil, eluate, leachate, and runoff samples. Among soil organisms, sensitivity was found to be E. crypticus < E. andrei < F. candida. Among the aqueous extracts, mortality of C. silvestrii was extreme in runoff samples, whereas eluates were by far the least toxic samples. A generally higher toxicity was found in the bioassays performed with samples from the field trial, indicating the need for improvements in the laboratory simulator. However, the tool developed proved to be valuable in evaluating the toxic effects of pesticide spraying in soils and the potential risks for aquatic compartments. Copyright © 2011 SETAC.

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. Copyright © 2013 Elsevier B.V. All rights reserved.

Repeatability of three-dimensional thorax and pelvis kinematics in the golf swing measured using a field-based motion capture system.

PubMed

Evans, Kerrie; Horan, Sean A; Neal, Robert J; Barrett, Rod S; Mills, Peter M

2012-06-01

Field-based methods of evaluating three-dimensional (3D) swing kinematics offer coaches and researchers the opportunity to assess golfers in context-specific environments. The purpose of this study was to establish the inter-trial, between-tester, between-location, and between-day repeatability of thorax and pelvis kinematics during the downswing using an electromagnetic motion capture system. Two experienced testers measured swing kinematics in 20 golfers (handicap < or =14 strokes) on consecutive days in an indoor and outdoor location. Participants performed five swings with each of two clubs (five-iron and driver) at each test condition. Repeatability of 3D kinematic data was evaluated by computing the coefficient of multiple determination (CMD) and the systematic error (SE). With the exception of pelvis forward bend for between-day and between-tester conditions, CMDs exceeded 0.854 for all variables, indicating high levels of overall waveform repeatability across conditions. When repeatability was compared across conditions using MANOVA, the lowest CMDs and highest SEs were found for the between-tester and between-day conditions. The highest CMDs were for the inter-trial and between-location conditions. The absence of significant differences in CMDs between these two conditions supports this method of analysing pelvis and thorax kinematics in different environmental settings without unduly affecting repeatability.

Radiation Field Design in the ACOSOG Z0011 (Alliance) Trial

PubMed Central

Jagsi, Reshma; Chadha, Manjeet; Moni, Janaki; Ballman, Karla; Laurie, Fran; Buchholz, Thomas A.; Giuliano, Armando; Haffty, Bruce G.

2014-01-01

Purpose ACOSOG Z0011 established that axillary lymph node dissection (ALND) is unnecessary in patients with breast cancer with one to two positive sentinel lymph nodes (SLNs) who undergo lumpectomy, radiotherapy (RT), and systemic therapy. We sought to ascertain RT coverage of the regional nodes in that trial. Methods We evaluated case report forms completed 18 months after enrollment. From 2012 to 2013, we collected all available detailed RT records for central review. Results Among 605 patients with completed case report forms, 89% received whole-breast RT. Of these, 89 (15%) were recorded as also receiving treatment to the supraclavicular region. Detailed RT records were obtained for 228 patients, of whom 185 (81.1%) received tangent-only treatment. Among 142 with sufficient records to evaluate tangent height, high tangents (cranial tangent border ≤ 2 cm from humeral head) were used in 50% of patients (33 of 66) randomly assigned to ALND and 52.6% (40 of 76) randomly assigned to SLND. Of the 228 patients with records reviewed, 43 (18.9%) received directed regional nodal RT using ≥ three fields: 22 in the ALND arm and 21 in the SLND arm. Those receiving directed nodal RT had greater nodal involvement (P < .001) than those who did not. Overall, there was no significant difference between treatment arms in the use of protocol-prohibited nodal fields. Conclusion Most patients treated in Z0011 received tangential RT alone, and some received no RT at all. Some patients received directed nodal irradiation via a third field. Further research is necessary to determine the optimal RT approach in patients with low-volume axillary disease treated with SLND alone. PMID:25135994

Guidelines for the Design and Conduct of Clinical Studies in Knee Articular Cartilage Repair

PubMed Central

Mithoefer, Kai; Saris, Daniel B.F.; Farr, Jack; Kon, Elizaveta; Zaslav, Kenneth; Cole, Brian J.; Ranstam, Jonas; Yao, Jian; Shive, Matthew; Levine, David; Dalemans, Wilfried; Brittberg, Mats

2011-01-01

Objective: To summarize current clinical research practice and develop methodological standards for objective scientific evaluation of knee cartilage repair procedures and products. Design: A comprehensive literature review was performed of high-level original studies providing information relevant for the design of clinical studies on articular cartilage repair in the knee. Analysis of cartilage repair publications and synopses of ongoing trials were used to identify important criteria for the design, reporting, and interpretation of studies in this field. Results: Current literature reflects the methodological limitations of the scientific evidence available for articular cartilage repair. However, clinical trial databases of ongoing trials document a trend suggesting improved study designs and clinical evaluation methodology. Based on the current scientific information and standards of clinical care, detailed methodological recommendations were developed for the statistical study design, patient recruitment, control group considerations, study endpoint definition, documentation of results, use of validated patient-reported outcome instruments, and inclusion and exclusion criteria for the design and conduct of scientifically sound cartilage repair study protocols. A consensus statement among the International Cartilage Repair Society (ICRS) and contributing authors experienced in clinical trial design and implementation was achieved. Conclusions: High-quality clinical research methodology is critical for the optimal evaluation of current and new cartilage repair technologies. In addition to generally applicable principles for orthopedic study design, specific criteria and considerations apply to cartilage repair studies. Systematic application of these criteria and considerations can facilitate study designs that are scientifically rigorous, ethical, practical, and appropriate for the question(s) being addressed in any given cartilage repair research project. PMID:26069574

Patient engagement in clinical trials: The Clinical Trials Transformation Initiative's leadership from theory to practical implementation.

PubMed

Patrick-Lake, Bray

2018-02-01

Patient engagement is an increasingly important aspect of successful clinical trials. Over the past decade, as patient group involvement in clinical trials has continued to increase and diversify, the Clinical Trials Transformation Initiative has not only recognized the crucial role patients play in improving the clinical trial enterprise but also made a deep commitment to help grow and shape the emerging field of patient engagement. This article describes the evolution of patient engagement including the origins of the patient engagement movement; barriers to successful engagement and remaining challenges to full and valuable collaboration between patient groups and trial sponsors; and Clinical Trials Transformation Initiative's role in influencing the field through organizational practices, formal project work and resulting recommendations, and external advocacy efforts.

The focus of Langenbeck's Archives of Surgery in the 21st century.

PubMed

Schneider, Martin; Weitz, Jürgen; Büchler, Markus W

2010-04-01

The Langenbeck's Archives of Surgery has been serving as a publication platform for clinical and scientific progress in the field of surgery for 150 years. In order to maintain this long-standing tradition throughout the coming decades, it will be mandatory to face the challenges posed by increasing specialization of surgical subdisciplines, modern technologies, and interdisciplinary treatment options. Continued efforts need to be directed at minimizing surgical trauma, not at least with respect to current demographic development. Adoption of progressive technologies from the fields of biophysics, mechatronics, and biomedical imaging solutions will likely gain a major impact on the further development of surgical operation techniques. Expanding insight from genomic and molecular medicine will facilitate personalized, interdisciplinary treatment concepts for malignant disease, in which surgical resection techniques will need to be integrated. The introduction of novel diagnostic and treatment concepts will mandate solid evaluation of their clinical effectiveness and safety, which can only be achieved by randomized, controlled trials in the field of surgery. Extracting study ideas from the contributions by clinicians and basic scientists, and promoting the conduction of clinical trials will therefore range among the most important tasks for the Langenbeck's Archives of Surgery in the 21st century.

Quantitative evaluation of human cerebellum-dependent motor learning through prism adaptation of hand-reaching movement.

PubMed

Hashimoto, Yuji; Honda, Takeru; Matsumura, Ken; Nakao, Makoto; Soga, Kazumasa; Katano, Kazuhiko; Yokota, Takanori; Mizusawa, Hidehiro; Nagao, Soichi; Ishikawa, Kinya

2015-01-01

The cerebellum plays important roles in motor coordination and learning. However, motor learning has not been quantitatively evaluated clinically. It thus remains unclear how motor learning is influenced by cerebellar diseases or aging, and is related with incoordination. Here, we present a new application for testing human cerebellum-dependent motor learning using prism adaptation. In our paradigm, the participant wearing prism-equipped goggles touches their index finger to the target presented on a touchscreen in every trial. The whole test consisted of three consecutive sessions: (1) 50 trials with normal vision (BASELINE), (2) 100 trials wearing the prism that shifts the visual field 25° rightward (PRISM), and (3) 50 trials without the prism (REMOVAL). In healthy subjects, the prism-induced finger-touch error, i.e., the distance between touch and target positions, was decreased gradually by motor learning through repetition of trials. We found that such motor learning could be quantified using the "adaptability index (AI)", which was calculated by multiplying each probability of [acquisition in the last 10 trials of PRISM], [retention in the initial five trials of REMOVAL], and [extinction in the last 10 trials of REMOVAL]. The AI of cerebellar patients less than 70 years old (mean, 0.227; n = 62) was lower than that of age-matched healthy subjects (0.867, n = 21; p < 0.0001). While AI did not correlate with the magnitude of dysmetria in ataxic patients, it declined in parallel with disease progression, suggesting a close correlation between the impaired cerebellar motor leaning and the dysmetria. Furthermore, AI decreased with aging in the healthy subjects over 70 years old compared with that in the healthy subjects less than 70 years old. We suggest that our paradigm of prism adaptation may allow us to quantitatively assess cerebellar motor learning in both normal and diseased conditions.

Quantitative Evaluation of Human Cerebellum-Dependent Motor Learning through Prism Adaptation of Hand-Reaching Movement

PubMed Central

Hashimoto, Yuji; Honda, Takeru; Matsumura, Ken; Nakao, Makoto; Soga, Kazumasa; Katano, Kazuhiko; Yokota, Takanori; Mizusawa, Hidehiro; Nagao, Soichi; Ishikawa, Kinya

2015-01-01

The cerebellum plays important roles in motor coordination and learning. However, motor learning has not been quantitatively evaluated clinically. It thus remains unclear how motor learning is influenced by cerebellar diseases or aging, and is related with incoordination. Here, we present a new application for testing human cerebellum-dependent motor learning using prism adaptation. In our paradigm, the participant wearing prism-equipped goggles touches their index finger to the target presented on a touchscreen in every trial. The whole test consisted of three consecutive sessions: (1) 50 trials with normal vision (BASELINE), (2) 100 trials wearing the prism that shifts the visual field 25° rightward (PRISM), and (3) 50 trials without the prism (REMOVAL). In healthy subjects, the prism-induced finger-touch error, i.e., the distance between touch and target positions, was decreased gradually by motor learning through repetition of trials. We found that such motor learning could be quantified using the “adaptability index (AI)”, which was calculated by multiplying each probability of [acquisition in the last 10 trials of PRISM], [retention in the initial five trials of REMOVAL], and [extinction in the last 10 trials of REMOVAL]. The AI of cerebellar patients less than 70 years old (mean, 0.227; n = 62) was lower than that of age-matched healthy subjects (0.867, n = 21; p < 0.0001). While AI did not correlate with the magnitude of dysmetria in ataxic patients, it declined in parallel with disease progression, suggesting a close correlation between the impaired cerebellar motor leaning and the dysmetria. Furthermore, AI decreased with aging in the healthy subjects over 70 years old compared with that in the healthy subjects less than 70 years old. We suggest that our paradigm of prism adaptation may allow us to quantitatively assess cerebellar motor learning in both normal and diseased conditions. PMID:25785588

Evaluation of Eight Methods for Aligning Orientation of Two Coordinate Systems.

PubMed

Mecheri, Hakim; Robert-Lachaine, Xavier; Larue, Christian; Plamondon, André

2016-08-01

The aim of this study was to evaluate eight methods for aligning the orientation of two different local coordinate systems. Alignment is very important when combining two different systems of motion analysis. Two of the methods were developed specifically for biomechanical studies, and because there have been at least three decades of algorithm development in robotics, it was decided to include six methods from this field. To compare these methods, an Xsens sensor and two Optotrak clusters were attached to a Plexiglas plate. The first optical marker cluster was fixed on the sensor and 20 trials were recorded. The error of alignment was calculated for each trial, and the mean, the standard deviation, and the maximum values of this error over all trials were reported. One-way repeated measures analysis of variance revealed that the alignment error differed significantly across the eight methods. Post-hoc tests showed that the alignment error from the methods based on angular velocities was significantly lower than for the other methods. The method using angular velocities performed the best, with an average error of 0.17 ± 0.08 deg. We therefore recommend this method, which is easy to perform and provides accurate alignment.

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.

How to Evaluate Phase Differences between Trial Groups in Ongoing Electrophysiological Signals

PubMed Central

VanRullen, Rufin

2016-01-01

A growing number of studies endeavor to reveal periodicities in sensory and cognitive functions, by comparing the distribution of ongoing (pre-stimulus) oscillatory phases between two (or more) trial groups reflecting distinct experimental outcomes. A systematic relation between the phase of spontaneous electrophysiological signals, before a stimulus is even presented, and the eventual result of sensory or cognitive processing for that stimulus, would be indicative of an intrinsic periodicity in the underlying neural process. Prior studies of phase-dependent perception have used a variety of analytical methods to measure and evaluate phase differences, and there is currently no established standard practice in this field. The present report intends to remediate this need, by systematically comparing the statistical power of various measures of “phase opposition” between two trial groups, in a number of real and simulated experimental situations. Seven measures were evaluated: one parametric test (circular Watson-Williams test), and three distinct measures of phase opposition (phase bifurcation index, phase opposition sum, and phase opposition product) combined with two procedures for non-parametric statistical testing (permutation, or a combination of z-score and permutation). While these are obviously not the only existing or conceivable measures, they have all been used in recent studies. All tested methods performed adequately on a previously published dataset (Busch et al., 2009). On a variety of artificially constructed datasets, no single measure was found to surpass all others, but instead the suitability of each measure was contingent on several experimental factors: the time, frequency, and depth of oscillatory phase modulation; the absolute and relative amplitudes of post-stimulus event-related potentials for the two trial groups; the absolute and relative trial numbers for the two groups; and the number of permutations used for non-parametric testing. The concurrent use of two phase opposition measures, the parametric Watson-Williams test and a non-parametric test based on summing inter-trial coherence values for the two trial groups, appears to provide the most satisfactory outcome in all situations tested. Matlab code is provided to automatically compute these phase opposition measures. PMID:27683543

Evaluation of imidacloprid-treated traps as an attract and kill system for filth flies during contingency operations.

PubMed

Dunford, James C; Hoel, David F; Hertz, Jeffrey C; England, David B; Dunford, Kelly R; Stoops, Craig A; Szumlas, Daniel E; Hogsette, Jerome A

2013-01-01

Two field trials were conducted to evaluate if filth fly trap efficacy was increased by augmentation with an insecticide application to the trap's exterior. Four Fly Terminator Pro traps (Farnam Companies, Inc, Phoenix, AZ) baited with Terminator Fly Attractant (in water) were suspended on polyvinyl chloride pipe framing at a municipal waste transfer site in Clay County, Florida. The outer surfaces of 2 traps were treated with Maxforce Fly Spot Bait (Bayer Environmental Science, Research Triangle Park, NC) (10% imidacloprid) to compare kill rates between treated and untreated traps. Kill consisted of total flies collected from inside traps and from mesh nets suspended beneath all traps, both treated and untreated. Each of 2 treated and untreated traps was rotated through 4 trap sites every 24 hrs. In order to evaluate operational utility and conservation of supplies during remote contingency operations, fly attractant remained in traps for the duration of the first trial but was changed daily during the second trial (following manufacturer's recommendations). In addition, ½ strength Terminator Fly Attractant was used during the first trial and traps were set at full strength during the second trial. Flies collected within the traps and in mesh netting were counted and identified. Three species, Musca domestica (L.), Chrysomya megacephala (F.), and Lucilia cuprina (Wiedemann), comprised the majority of samples in both trials. The net samples recovered more flies when the outer surface was treated with imidacloprid, however, treated traps collected fewer flies inside the trap than did untreated traps for both trials. No significant statistical advantage was found in treating Fly Terminator Pro trap exteriors with Maxforce Fly Spot Bait. However, reducing manufacturer's recommended strength of Terminator Fly Attractant showed similar results to traps set at full strength. Treating the outer surfaces may improve kill of fly species that do not enter the trap. Terminator Fly Attractant was also found to be more effective if traps were not changed daily and left to hold dead flies for longer periods.

An integrated vegetated ditch system reduces chlorpyrifos loading in agricultural runoff.

PubMed

Phillips, Bryn M; Anderson, Brian S; Cahn, Michael; Rego, Jessa L; Voorhees, Jennifer P; Siegler, Katie; Zhang, Xuyang; Budd, Robert; Goh, Kean; Tjeerdema, Ron S

2017-03-01

Agricultural runoff containing toxic concentrations of the organophosphate pesticide chlorpyrifos has led to impaired water body listings and total maximum daily load restrictions in California's central coast watersheds. Chlorpyrifos use is now tightly regulated by the Central Coast Regional Water Quality Control Board. This study evaluated treatments designed to reduce chlorpyrifos in agricultural runoff. Initial trials evaluated the efficacy of 3 different drainage ditch installations individually: compost filters, granulated activated carbon (GAC) filters, and native grasses in a vegetated ditch. Treatments were compared to bare ditch controls, and experiments were conducted with simulated runoff spiked with chlorpyrifos at a 1.9 L/s flow rate. Chlorpyrifos concentrations and toxicity to Ceriodaphnia dubia were measured at the input and output of the system. Input concentrations of chlorpyrifos ranged from 858 ng/L to 2840 ng/L. Carbon filters and vegetation provided the greatest load reduction of chlorpyrifos (99% and 90%, respectively). Toxicity was completely removed in only one of the carbon filter trials. A second set of trials evaluated an integrated approach combining all 3 treatments. Three trials were conducted each at 3.2 L/s and 6.3 L/s flow rates at input concentrations ranging from 282 ng/L to 973 ng/L. Chlorpyrifos loadings were reduced by an average of 98% at the low flow rate and 94% at the high flow rate. Final chlorpyrifos concentrations ranged from nondetect (<50 ng/L) to 82 ng/L. Toxicity to C. dubia was eliminated in 3 of 6 integrated trials. Modeling of the ditch and its components informed design alterations that are intended to eventually remove up to 100% of pesticides and sediment. Future work includes investigating the adsorption capacity of GAC, costs associated with GAC disposal, and real-world field trials to further reduce model uncertainties and confirm design optimization. Trials with more water-soluble pesticides such as neonicotinoids are also recommended. Integr Environ Assess Manag 2017;13:423-430. © 2016 SETAC. © 2016 SETAC.

Implementation of evidence-based treatment for schizophrenic disorders: two-year outcome of an international field trial of optimal treatment

PubMed Central

Falloon, Ian RH; Montero, Isabel; Sungur, Mehmet; Mastroeni, Antonino; Malm, Ulf; Economou, Marina; Grawe, Rolf; Harangozo, Judit; Mizuno, Masafumi; Murakami, Masaaki; Hager, Bert; Held, Tilo; Veltro, Franco; Gedye, Robyn

2004-01-01

According to clinical trials literature, every person with a schizophrenic disorder should be provided with the combination of optimal dose antipsychotics, strategies to educate himself and his carers to cope more efficiently with environmental stresses, cognitive-behavioural strategies to enhance work and social goals and reducing residual symptoms, and assertive home-based management to help prevent and resolve major social needs and crises, including recurrent episodes of symptoms. Despite strong scientific support for the routine implementation of these 'evidence-based' strategies, few services provide more than the pharmacotherapy component, and even this is seldom applied in the manner associated with the best results in the clinical trials. An international collaborative group, the Optimal Treatment Project (OTP), has been developed to promote the routine use of evidence-based strategies for schizophrenic disorders. A field trial was started to evaluate the benefits and costs of applying evidence-based strategies over a 5-year period. Centres have been set up in 18 countries. This paper summarises the outcome after 24 months of 'optimal' treatment in 603 cases who had reached this stage in their treatment by the end of 2002. On all measures the evidence-based OTP approach achieved more than double the benefits associated with current best practices. One half of recent cases had achieved full recovery from clinical and social morbidity. These advantages were even more striking in centres where a random-control design was used. PMID:16633471

Implementation of evidence-based treatment for schizophrenic disorders: two-year outcome of an international field trial of optimal treatment.

PubMed

Falloon, Ian R H; Montero, Isabel; Sungur, Mehmet; Mastroeni, Antonino; Malm, Ulf; Economou, Marina; Grawe, Rolf; Harangozo, Judit; Mizuno, Masafumi; Murakami, Masaaki; Hager, Bert; Held, Tilo; Veltro, Franco; Gedye, Robyn

2004-06-01

According to clinical trials literature, every person with a schizophrenic disorder should be provided with the combination of optimal dose antipsychotics, strategies to educate himself and his carers to cope more efficiently with environmental stresses, cognitive-behavioural strategies to enhance work and social goals and reducing residual symptoms, and assertive home-based management to help prevent and resolve major social needs and crises, including recurrent episodes of symptoms. Despite strong scientific support for the routine implementation of these 'evidence-based' strategies, few services provide more than the pharmacotherapy component, and even this is seldom applied in the manner associated with the best results in the clinical trials. An international collaborative group, the Optimal Treatment Project (OTP), has been developed to promote the routine use of evidence-based strategies for schizophrenic disorders. A field trial was started to evaluate the benefits and costs of applying evidence-based strategies over a 5-year period. Centres have been set up in 18 countries. This paper summarises the outcome after 24 months of 'optimal' treatment in 603 cases who had reached this stage in their treatment by the end of 2002. On all measures the evidence-based OTP approach achieved more than double the benefits associated with current best practices. One half of recent cases had achieved full recovery from clinical and social morbidity. These advantages were even more striking in centres where a random-control design was used.

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

PubMed Central

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

2011-01-01

Evaluative bibliometrics uses advanced techniques to assess the impact of scholarly work in the context of other scientific work and usually compares the relative scientific contributions of research groups or institutions. Using publications from the National Institute of Allergy and Infectious Diseases (NIAID) HIV/AIDS extramural clinical trials networks, we assessed the presence, performance, and impact of papers published in 2006–2008. Through this approach, we sought to expand traditional bibliometric analyses beyond citation counts to include normative comparisons across journals and fields, visualization of co-authorship across the networks, and assess the inclusion of publications in reviews and syntheses. Specifically, we examined the research output of the networks in terms of the a) presence of papers in the scientific journal hierarchy ranked on the basis of journal influence measures, b) performance of publications on traditional bibliometric measures, and c) impact of publications in comparisons with similar publications worldwide, adjusted for journals and fields. We also examined collaboration and interdisciplinarity across the initiative, through network analysis and modeling of co-authorship patterns. Finally, we explored the uptake of network produced publications in research reviews and syntheses. Overall, the results suggest the networks are producing highly recognized work, engaging in extensive interdisciplinary collaborations, and having an impact across several areas of HIV-related science. The strengths and limitations of the approach for evaluation and monitoring research initiatives are discussed. PMID:21394198

An evaluation of antimicrobial therapy for undifferentiated bovine respiratory disease

PubMed Central

Bateman, Ken G.; Martin, S. Wayne; Shewen, Patricia E.; Menzies, Paula I.

1990-01-01

A field trial of antimicrobial therapy for cases of undifferentiated bovine respiratory disease (UBRD) in beef calves was conducted at four Ontario feedlots. The primary purpose of the trial was to evaluate the efficacy of three different antimicrobials (oxytetracycline, penicillin, and trimethoprim-sulfadoxine) in the treatment of UBRD occurring within the first 28 days postarrival. The response, relapse, and case fatality rates overall were 85.7%, 14.8%, and 1.4%, respectively, and were not significantly different among the three antimicrobials evaluated. Weight gains of calves treated with the different drugs were not statistically different over the feeding period. Calves that suffered a relapse posttreatment were first treated significantly earlier (p<0.001) in the postarrival period than those that did not relapse. Considered together, treated calves gained significantly less (p<0.05) over the first 28 days and throughout the entire feeding period than controls that were never sick. Cases of UBRD that responded to therapy and did not relapse had rates of gain that were not significantly different from the controls. PMID:17423676

Feasibility and acceptability of the DSM-5 Field Trial procedures in the Johns Hopkins Community Psychiatry Programs.

PubMed

Clarke, Diana E; Wilcox, Holly C; Miller, Leslie; Cullen, Bernadette; Gerring, Joan; Greiner, Lisa H; Newcomer, Alison; McKitty, Mellisha V; Regier, Darrel A; Narrow, William E

2014-06-01

The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) contains criteria for psychiatric diagnoses that reflect advances in the science and conceptualization of mental disorders and address the needs of clinicians. DSM-5 also recommends research on dimensional measures of cross-cutting symptoms and diagnostic severity, which are expected to better capture patients' experiences with mental disorders. Prior to its May 2013 release, the American Psychiatric Association (APA) conducted field trials to examine the feasibility, clinical utility, reliability, and where possible, the validity of proposed DSM-5 diagnostic criteria and dimensional measures. The methods and measures proposed for the DSM-5 field trials were pilot tested in adult and child/adolescent clinical samples, with the goal to identify and correct design and procedural problems with the proposed methods before resources were expended for the larger DSM-5 Field Trials. Results allowed for the refinement of the protocols, procedures, and measures, which facilitated recruitment, implementation, and completion of the DSM-5 Field Trials. These results highlight the benefits of pilot studies in planning large multisite studies. Copyright © 2013, American Psychiatric Association. All rights reserved.

Differentiation of organic and non-organic winter wheat cultivars from a controlled field trial by crystallization patterns.

PubMed

Kahl, Johannes; Busscher, Nicolaas; Mergardt, Gaby; Mäder, Paul; Torp, Torfinn; Ploeger, Angelika

2015-01-01

There is a need for authentication tools in order to verify the existing certification system. Recently, markers for analytical authentication of organic products were evaluated. Herein, crystallization with additives was described as an interesting fingerprint approach which needs further evidence, based on a standardized method and well-documented sample origin. The fingerprint of wheat cultivars from a controlled field trial is generated from structure analysis variables of crystal patterns. Method performance was tested on factors such as crystallization chamber, day of experiment and region of interest of the patterns. Two different organic treatments and two different treatments of the non-organic regime can be grouped together in each of three consecutive seasons. When the k-nearest-neighbor classification method was applied, approximately 84% of Runal samples and 95% of Titlis samples were classified correctly into organic and non-organic origin using cross-validation. Crystallization with additive offers an interesting complementary fingerprint method for organic wheat samples. When the method is applied to winter wheat from the DOK trial, organic and non-organic treated samples can be differentiated significantly based on pattern recognition. Therefore crystallization with additives seems to be a promising tool in organic wheat authentication. © 2014 Society of Chemical Industry.

Surfactants as blackbird stressing agents

USGS Publications Warehouse

Lefebvre, P.W.; Seubert, J.L.

1970-01-01

Applications of wetting-agent solutions produce mortality in birds. The exact cause of death is undetermined but it is believed that destruction of the insulating qualities of the plumage permits ambient cold temperatures and evaporation to lower the body temperature to a lethal level. The original concept of using these materials as bird-control tools was developed in 1958 at the Patuxent Wildlife Research Center, Bureau of Sport Fisheries and Wildlife Laurel, Maryland. Early field trials by personnel of the Division of Wildlife Services and the Denver Wildlife Research Center indicated that ground-application techniques had promise but limitations of the equipment precluded successful large-scale roost treatments. In 1966, Patuxent Center personnel began using tanker-type aircraft to evaluate high-volume aerial applications of wetting agents. The success of these tests led to the use of small aircraft to make low-volume, high-concentration aerial applications just prior to expected rainfall. Recent trials of the low-volume method show that, with some limitations, it is effective, inexpensive, and safe to the environment. Current research emphasizes the screening of new candidate materials for efficacy, biodegradability, and toxicity to plants and non-target animals, as well as basic investigations of the avian physiological mechanisms involved. Field trials to develop more effective application techniques will continue.

Using Small-Scale Randomized Controlled Trials to Evaluate the Efficacy of New Curricular Materials

PubMed Central

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 researchers asked whether the curricular materials improved students’ understanding of the content more than an alternative set of activities. The field test was conducted in a diverse public high school setting with 145 students who were randomly assigned to a treatment or comparison condition. Findings indicate that students in the treatment condition scored significantly higher on the posttest than did students in the comparison group (effect size: Cohen's d = 0.40). The paper discusses the strengths and limitations of the RCT, the contextual factors that influenced its enactment, and recommendations for others wishing to conduct small-scale rigorous evaluations in educational settings. Our intention is for this paper to serve as a case study for university science faculty members who wish to employ scientifically rigorous evaluations in K–12 settings while limiting the scope and budget of their work. PMID:25452482

Contralateral eye comparison on changes in visual field following laser in situ keratomileusis vs photorefractive keratectomy for myopia: a randomized clinical trial.

PubMed

Mostafaei, A; Sedgipour, M R; Sadeghi-Bazargani, H

2009-12-01

Study purpose was to compare the changes of Visual Field (VF) during laser in situ Keratomileusis (LASIK) VS photorefractive keratectomy (PRK). This randomized, double blind, study involved 54 eyes of 27 Myopia patients who underwent LASIK or PRK procedures for contralateral eyes in each patient. Using Humphrey 30-2 SITA standard, the Mean Defect (MD) and Pattern Standard Deviation (PSD) were evaluated preoperatively and three months after surgery. At the same examination optical zone size, papillary and corneal diameters were also evaluated. There was no clinically significant difference in PSD and MD measurements between treated eyes with LASIK or PRK in any zone pre and postoperatively. VF may not be affected by corneal changes induced by LASIK or PRK three months after surgery.

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.

Development of a Mobile Tool That Semiautomatically Screens Patients for Stroke Clinical Trials.

PubMed

Spokoyny, Ilana; Lansberg, Maarten; Thiessen, Rosita; Kemp, Stephanie M; Aksoy, Didem; Lee, YongJae; Mlynash, Michael; Hirsch, Karen G

2016-10-01

Despite several national coordinated research networks, enrollment in many cerebrovascular trials remains challenging. An electronic tool was needed that would improve the efficiency and efficacy of screening for multiple simultaneous acute clinical stroke trials by automating the evaluation of inclusion and exclusion criteria, improving screening procedures and streamlining the communication process between the stroke research coordinators and the stroke clinicians. A multidisciplinary group consisting of physicians, study coordinators, and biostatisticians designed and developed an electronic clinical trial screening tool on a HIPAA (Health Insurance Portability and Accountability Act)-compliant platform. A web-based tool was developed that uses branch logic to determine eligibility for simultaneously enrolling clinical trials and automatically notifies the study coordinator teams about eligible patients. After 12 weeks of use, 225 surveys were completed, and 51 patients were enrolled in acute stroke clinical trials. Compared with the 12 weeks before implementation of the tool, there was an increase in enrollment from 16.5% of patients screened to 23.4% of patients screened (P<0.05). Clinicians and coordinators reported increased satisfaction with the process and improved ease of screening. We created a semiautomated electronic screening tool that uses branch logic to screen patients for stroke clinical trials. The tool has improved efficiency and efficacy of screening, and it could be adapted for use at other sites and in other medical fields. © 2016 American Heart Association, Inc.

Epidemiological Survey for Incidence of Shigellosis and Hepatitis to Evaluate Potential Field Test Sites for Vaccine Trials. Part 1. Shigellosis

DTIC Science & Technology

1988-03-01

06 BACTERIOLOGY-, SHIGELLA VACCINES, RIA, HEPATITIS A. iS di . i L ’ 7 Z1 i s I2y w a , t o (:I e (- 11neLh e i r u- (I n:~ ’I~ q I𔃻 .1ie iec sd unI...the IDF and to evaluate the associa- homologous Shigella and the occurrence of disease. In this study, soldiers in five units were followed...assay (ELISA). Epidemic and sporadic morbidity due to Shigella organisms was identified using bacter- iological and serological diagnostic methods. The

Different methods of image segmentation in the process of meat marbling evaluation

NASA Astrophysics Data System (ADS)

Ludwiczak, A.; Ślósarz, P.; Lisiak, D.; Przybylak, A.; Boniecki, P.; Stanisz, M.; Koszela, K.; Zaborowicz, M.; Przybył, K.; Wojcieszak, D.; Janczak, D.; Bykowska, M.

2015-07-01

The level of marbling in meat assessment based on digital images is very popular, as computer vision tools are becoming more and more advanced. However considering muscle cross sections as the data source for marbling level evaluation, there are still a few problems to cope with. There is a need for an accurate method which would facilitate this evaluation procedure and increase its accuracy. The presented research was conducted in order to compare the effect of different image segmentation tools considering their usefulness in meat marbling evaluation on the muscle anatomical cross - sections. However this study is considered to be an initial trial in the presented field of research and an introduction to ultrasonic images processing and analysis.

Development of a core outcome set for medication review in older patients with multimorbidity and polypharmacy: a study protocol.

PubMed

Beuscart, Jean-Baptiste; Dalleur, Olivia; Boland, Benoit; Thevelin, Stefanie; Knol, Wilma; Cullinan, Shane; Schneider, Claudio; O'Mahony, Denis; Rodondi, Nicolas; Spinewine, Anne

2017-01-01

Medication review has been advocated to address the challenge of polypharmacy in older patients, yet there is no consensus on how best to evaluate its efficacy. Heterogeneity of outcomes reported in clinical trials can hinder the comparison of clinical trial findings in systematic reviews. Moreover, the outcomes that matter most to older patients might be under-reported or disregarded altogether. A core outcome set can address this issue as it defines a minimum set of outcomes that should be reported in all clinical trials in any particular field of research. As part of the European Commission-funded project, called OPtimising thERapy to prevent Avoidable hospital admissions in the Multimorbid elderly, this paper describes the methods used to develop a core outcome set for clinical trials of medication review in older patients with multimorbidity. The study was designed in several steps. First, a systematic review established which outcomes were measured in published and ongoing clinical trials of medication review in older patients. Second, we undertook semistructured interviews with older patients and carers aimed at identifying additional relevant outcomes. Then, a multilanguage European Delphi survey adapted to older patients was designed. The international Delphi survey was conducted with older patients, health care professionals, researchers, and clinical experts in geriatric pharmacotherapy to validate outcomes to be included in the core outcome set. Consensus meetings were conducted to validate the results. We present the method for developing a core outcome set for medication review in older patients with multimorbidity. This study protocol could be used as a basis to develop core outcome sets in other fields of geriatric research.

A standard-driven approach for electronic submission to pharmaceutical regulatory authorities.

PubMed

Lin, Ching-Heng; Chou, Hsin-I; Yang, Ueng-Cheng

2018-03-01

Using standards is not only useful for data interchange during the process of a clinical trial, but also useful for analyzing data in a review process. Any step, which speeds up approval of new drugs, may benefit patients. As a result, adopting standards for regulatory submission becomes mandatory in some countries. However, preparing standard-compliant documents, such as annotated case report form (aCRF), needs a great deal of knowledge and experience. The process is complex and labor-intensive. Therefore, there is a need to use information technology to facilitate this process. Instead of standardizing data after the completion of a clinical trial, this study proposed a standard-driven approach. This approach was achieved by implementing a computer-assisted "standard-driven pipeline (SDP)" in an existing clinical data management system. SDP used CDISC standards to drive all processes of a clinical trial, such as the design, data acquisition, tabulation, etc. RESULTS: A completed phase I/II trial was used to prove the concept and to evaluate the effects of this approach. By using the CDISC-compliant question library, aCRFs were generated automatically when the eCRFs were completed. For comparison purpose, the data collection process was simulated and the collected data was transformed by the SDP. This new approach reduced the missing data fields from sixty-two to eight and the controlled term mismatch field reduced from eight to zero during data tabulation. This standard-driven approach accelerated CRF annotation and assured data tabulation integrity. The benefits of this approach include an improvement in the use of standards during the clinical trial and a reduction in missing and unexpected data during tabulation. The standard-driven approach is an advanced design idea that can be used for future clinical information system development. Copyright © 2018 Elsevier Inc. All rights reserved.

Evaluating Nicotine Replacement Therapy and Stage-Based Therapies in a Population-Based Effectiveness Trial

ERIC Educational Resources Information Center

Velicer, Wayne F.; Friedman, Robert H.; Fava, Joseph L.; Gulliver, Suzy B.; Keller, Stefan; Sun, Xiaowu; Ramelson, Harley; Prochaska, James O.

2006-01-01

Pharmacological interventions for smoking cessation are typically evaluated using volunteer samples (efficacy trials) but should also be evaluated in population-based trials (effectiveness trials). Nicotine replacement therapy (NRT) alone and in combination with behavioral interventions was evaluated on a population of smokers from a New England…

Soil stabilization field trial : interim report II.

DOT National Transportation Integrated Search

2002-02-01

Shrinkage cracks in cement-stabilized bases/subbase can be alleviated by specifying the right cement dosage, or by other additives/procedures that suppress crack susceptibility. A field trial of six 1000 ft sections to investigate several alternative...

Soil stabilization field trial : interim report.

DOT National Transportation Integrated Search

2001-04-01

Shrinkage cracks in cement-stabilized bases/subbase can be alleviated by specifying : the right cement dosage, or by other additives/procedures that suppress crack susceptibility. A field : trial of six 1000 ft test sections to investigate several al...

Field trial of solvent-free emulsion in Oregon : appendices.

DOT National Transportation Integrated Search

2003-03-01

This final report summarizes construction, laboratory and performance information gathered by ODOT personnel from a single field trial of solvent-free emulsion mix constructed in June 2001. The solvent-free emulsion mix presented several placement pr...

Soil stabilization field trial : interim report I.

DOT National Transportation Integrated Search

2001-04-01

Shrinkage cracks in cement-stabilized bases/subbase can be alleviated by specifying the right cement dosage, or by other additives/procedures that suppress crack susceptibility. A field trial of six 1000 ft test sections to investigate several altern...

Soil stabilization field trial : interim report III.

DOT National Transportation Integrated Search

2003-11-01

Shrinkage cracks in cement-stabilized bases/subbase can be alleviated by specifying the right cement dosage, or by other additives/procedures that suppress crack susceptibility. A field trial of six 1000 ft test sections to investigate several altern...

Biomarkers and surrogate endpoints in kidney disease

PubMed Central

2015-01-01

Kidney disease and its related comorbidities impose a large public health burden. Despite this, the number of clinical trials in nephrology lags behind many other fields. An important factor contributing to the relatively slow pace of nephrology trials is that existing clinical endpoints have significant limitations. “Hard” endpoints for chronic kidney disease, such as progression to end-stage renal disease, may not be reached for decades. Traditional biomarkers, such as serum creatinine in acute kidney injury, may lack sensitivity and predictive value. Finding new biomarkers to serve as surrogate endpoints is therefore an important priority in kidney disease research and may help to accelerate nephrology clinical trials. In this paper, I first review key concepts related to the selection of clinical trial endpoints and discuss statistical and regulatory considerations related to the evaluation of biomarkers as surrogate endpoints. This is followed by a discussion of the challenges and opportunities in developing novel biomarkers and surrogate endpoints in three major areas of nephrology research: acute kidney injury, chronic kidney disease, and autosomal dominant polycystic kidney disease. PMID:25980469

The Plant Alkaloid Camptothecin as a Novel Antifouling Compound for Marine Paints: Laboratory Bioassays and Field Trials.

PubMed

Feng, Dan Qing; He, Jian; Chen, Si Yu; Su, Pei; Ke, Cai Huan; Wang, Wei

2018-06-02

The extensive use of copper and booster biocides in antifouling (AF) paints has raised environmental concerns and the need to develop new AF agents. In the present study, 18 alkaloids derived from terrestrial plants were initially evaluated for AF activity using laboratory bioassays with the bryozoan Bugula neritina and the barnacle Balanus albicostatus. The results showed that 4 of the 18 alkaloids were effective in inhibiting larval settlement of B. neritina, with an EC 50 range of 6.18 to 43.11 μM, and 15 of the 18 alkaloids inhibited larval settlement of B. albicostatus, with EC 50 values ranging from 1.18 to 67.58 μM. Field trials that incorporated five alkaloids respectively into paints with 20% w/w indicated an in situ AF efficiency of evodiamine, strychnine, camptothecin (CPT), and cepharanthine, with the most potent compound being CPT, which also exhibited stronger AF efficiency than the commercial antifoulants cuprous oxide and zinc pyrithione in the field over a period of 12 months. Further field trials with different CPT concentrations (0.1 to 20% w/w) in the paints suggested a concentration-dependent AF performance in the natural environment, and the effective concentrations to significantly inhibit settlement of biofoulers in the field were ≥ 0.5% w/w (the efficiency of 0.5% w/w lasted for 2 months). Moreover, CPT toxicity against the crustacean Artemia salina, the planktonic microalgae Phaeodactylum tricornutum and Isochrysis galbana, was examined. The results showed that 24 h LC 50 of CPT against A. salina was 20.75 μM, and 96 h EC 50 (growth inhibition) values of CPT to P. tricornutum and I. galbana were 55.81 and 6.29 μM, respectively, indicating that CPT was comparatively less toxic than several commercial antifoulants previously reported. Our results suggest the novel potential application of CPT as an antifoulant.

Description and Evaluation of a Four-Channel, Coherent 100-kHz Sidescan Sonar

DTIC Science & Technology

2004-12-01

document contains color images. 14. ABSTRACT This report documents the design and features of a new, four-channel, coherent 100-kHz sidescan sonar...Atlantic Technical Memorandum DRDC Atlantic TM 2004-204 December 2004 Abstract This report documents the design and features of a new...Results This report documents the design and features of this new high-frequency sonar system. These initial field trial results demonstrate some of

Present state of HDTV coding in Japan and future prospect

NASA Astrophysics Data System (ADS)

Murakami, Hitomi

The development status of HDTV digital codecs in Japan is evaluated; several bit rate-reduction codecs have been developed for 1125 lines/60-field HDTV, and performance trials have been conducted through satellite and optical fiber links. Prospective development efforts will attempt to achieve more efficient coding schemes able to reduce the bit rate to as little as 45 Mbps, as well as to apply coding schemes to automated teller machine networks.

A national portfolio of bone oncology trials—The Canadian experience in 2012

PubMed Central

Kuchuk, I.; Simos, D.; Addison, C.L.; Clemons, M.

2012-01-01

Background The impact of both cancer and its treatment on bone is an essential component of oncological practice. Bone oncology not only affects patients with both early stage and metastatic disease but also covers the entire spectrum of tumour types. We therefore decided to review and summarise bone oncology-related trials that are currently being conducted in Canada. Method We assessed ongoing and recently completed trials in Canada. We used available North American and Canadian cancer trial websites and also contacted known investigators in this field for their input. Results Twenty seven clinical trials were identified. Seven pertained to local treatment of bone metastasis from any solid tumour type. Seven were systemic treatment trials, five focused on bone biology and predictive factors, three evaluated safety of bone-targeted agents, three were adjuvant trials and two trials investigated impact of cancer therapy on bone health. The majority of trials were related to systemic treatment and bone biology in breast cancer. Most were small, single centre, grant-funded studies. Not surprisingly the larger safety and adjuvant studies were pharmaceutical company driven. Discussion Despite the widespread interest in bone-targeted therapies our survey would suggest that most studies are single centre and breast cancer focused. If major advances in bone oncology are to be made then collaborative strategies are needed to not only increase current sample sizes but to also expand these studies into non-breast cancer populations. PMID:26909263

Sequential analysis applied to clinical trials in dentistry: a systematic review.

PubMed

Bogowicz, P; Flores-Mir, C; Major, P W; Heo, G

2008-01-01

Clinical trials employ sequential analysis for the ethical and economic benefits it brings. In dentistry, as in other fields, resources are scarce and efforts are made to ensure that patients are treated ethically. The objective of this systematic review was to characterise the use of sequential analysis for clinical trials in dentistry. We searched various databases from 1900 through to January 2008. Articles were selected for review if they were clinical trials in the field of dentistry that had applied some form of sequential analysis. Selection was carried out independently by two of the authors. We included 18 trials from various specialties, which involved many different interventions. We conclude that sequential analysis seems to be underused in this field but that there are sufficient methodological resources in place for future applications.Evidence-Based Dentistry (2008) 9, 55-62. doi:10.1038/sj.ebd.6400587.

Critical appraisal of arguments for the delayed-start design proposed as alternative to the parallel-group randomized clinical trial design in the field of rare disease.

PubMed

Spineli, Loukia M; Jenz, Eva; Großhennig, Anika; Koch, Armin

2017-08-17

A number of papers have proposed or evaluated the delayed-start design as an alternative to the standard two-arm parallel group randomized clinical trial (RCT) design in the field of rare disease. However the discussion is felt to lack a sufficient degree of consideration devoted to the true virtues of the delayed start design and the implications either in terms of required sample-size, overall information, or interpretation of the estimate in the context of small populations. To evaluate whether there are real advantages of the delayed-start design particularly in terms of overall efficacy and sample size requirements as a proposed alternative to the standard parallel group RCT in the field of rare disease. We used a real-life example to compare the delayed-start design with the standard RCT in terms of sample size requirements. Then, based on three scenarios regarding the development of the treatment effect over time, the advantages, limitations and potential costs of the delayed-start design are discussed. We clarify that delayed-start design is not suitable for drugs that establish an immediate treatment effect, but for drugs with effects developing over time, instead. In addition, the sample size will always increase as an implication for a reduced time on placebo resulting in a decreased treatment effect. A number of papers have repeated well-known arguments to justify the delayed-start design as appropriate alternative to the standard parallel group RCT in the field of rare disease and do not discuss the specific needs of research methodology in this field. The main point is that a limited time on placebo will result in an underestimated treatment effect and, in consequence, in larger sample size requirements compared to those expected under a standard parallel-group design. This also impacts on benefit-risk assessment.

Economic evaluation of Community Level Interventions for Pre-eclampsia (CLIP) in South Asian and African countries: a study protocol.

PubMed

Khowaja, Asif R; Mitton, Craig; Bryan, Stirling; Magee, Laura A; Bhutta, Zulfiqar A; von Dadelszen, Peter

2015-05-26

Globally, hypertensive disorders of pregnancy, particularly pre-eclampsia and eclampsia, are the leading cause of maternal and neonatal mortality, and impose substantial burdens on the families of pregnant women, their communities, and healthcare systems. The Community Level Interventions for Pre-eclampsia (CLIP) Trial evaluates a package of care applied at both community and primary health centres to reduce maternal and perinatal disabilities and deaths resulting from the failure to identify and manage pre-eclampsia at the community level. Economic evaluation of health interventions can play a pivotal role in priority setting and inform policy decisions for scale-up. At present, there is a paucity of published literature on the methodology of economic evaluation of large, multi-country, community-based interventions in the area of maternal and perinatal health. This study protocol describes the application of methodology for economic evaluation of the CLIP in South Asia and Africa. A mixed-design approach i.e. cost-effectiveness analysis (CEA) and qualitative thematic analysis will be used alongside the trial to prospectively evaluate the economic impact of CLIP from a societal perspective. Data on health resource utilization, costs, and pregnancy outcomes will be collected through structured questionnaires embedded into the pregnancy surveillance, cross-sectional survey and budgetary reviews. Qualitative data will be collected through focus groups (FGs) with pregnant women, household male-decision makers, care providers, and district level health decision makers. The incremental cost-effectiveness ratio will be calculated for healthcare system and societal perspectives, taking into account the country-specific model inputs (costs and outcome) from the CLIP Trial. Emerging themes from FGs will inform the design of the model, and help to interpret findings of the CEA. The World Health Organization (WHO) strongly recommends cost-effective interventions as a key aspect of achieving Millennium Development Goal (MDG)-5 (i.e. 75 % reduction in maternal mortality from 1990 levels by 2015). To date, most cost-effectiveness studies in this field have focused specifically on the diagnostic and clinical management of pre-eclampsia, yet rarely on community-based interventions in low-and-middle-income countries (LMICs). This study protocol will be of interest to public health scientists and health economists undertaking community-based trials in the area of maternal and perinatal health, particularly in LMICs. ClinicalTrials.gov: NCT01911494.

Veterinary and human vaccine evaluation methods

PubMed Central

Knight-Jones, T. J. D.; Edmond, K.; Gubbins, S.; Paton, D. J.

2014-01-01

Despite the universal importance of vaccines, approaches to human and veterinary vaccine evaluation differ markedly. For human vaccines, vaccine efficacy is the proportion of vaccinated individuals protected by the vaccine against a defined outcome under ideal conditions, whereas for veterinary vaccines the term is used for a range of measures of vaccine protection. The evaluation of vaccine effectiveness, vaccine protection assessed under routine programme conditions, is largely limited to human vaccines. Challenge studies under controlled conditions and sero-conversion studies are widely used when evaluating veterinary vaccines, whereas human vaccines are generally evaluated in terms of protection against natural challenge assessed in trials or post-marketing observational studies. Although challenge studies provide a standardized platform on which to compare different vaccines, they do not capture the variation that occurs under field conditions. Field studies of vaccine effectiveness are needed to assess the performance of a vaccination programme. However, if vaccination is performed without central co-ordination, as is often the case for veterinary vaccines, evaluation will be limited. This paper reviews approaches to veterinary vaccine evaluation in comparison to evaluation methods used for human vaccines. Foot-and-mouth disease has been used to illustrate the veterinary approach. Recommendations are made for standardization of terminology and for rigorous evaluation of veterinary vaccines. PMID:24741009

Pulsed Electromagnetic Fields in the treatment of fresh scaphoid fractures. A multicenter, prospective, double blind, placebo controlled, randomized trial.

PubMed

Hannemann, Pascal; Göttgens, Kevin W A; van Wely, Bob J; Kolkman, Karel A; Werre, Andries J; Poeze, Martijn; Brink, Peter R G

2011-05-06

The scaphoid bone is the most commonly fractured of the carpal bones. In the Netherlands 90% of all carpal fractures is a fracture of the scaphoid bone. The scaphoid has an essential role in functionality of the wrist, acting as a pivot. Complications in healing can result in poor functional outcome. The scaphoid fracture is a troublesome fracture and failure of treatment can result in avascular necrosis (up to 40%), non-union (5-21%) and early osteo-arthritis (up to 32%) which may seriously impair wrist function. Impaired consolidation of scaphoid fractures results in longer immobilization and more days lost at work with significant psychosocial and financial consequences.Initially Pulsed Electromagnetic Fields was used in the treatment of tibial pseudoarthrosis and non-union. More recently there is evidence that physical forces can also be used in the treatment of fresh fractures, showing accelerated healing by 30% and 71% reduction in nonunion within 12 weeks after initiation of therapy. Until now no double blind randomized, placebo controlled trial has been conducted to investigate the effect of this treatment on the healing of fresh fractures of the scaphoid. This is a multi center, prospective, double blind, placebo controlled, randomized trial. Study population consists of all patients with unilateral acute scaphoid fracture. Pregnant women, patients having a life supporting implanted electronic device, patients with additional fractures of wrist, carpal or metacarpal bones and pre-existing impairment in wrist function are excluded. The scaphoid fracture is diagnosed by a combination of physical and radiographic examination (CT-scanning).Proven scaphoid fractures are treated with cast immobilization and a small Pulsed Electromagnetic Fields bone growth stimulating device placed on the cast. Half of the devices will be disabled at random in the factory.Study parameters are clinical consolidation, radiological consolidation evaluated by CT-scanning, functional status of the wrist, including assessment by means of the patient rated wrist evaluation (PRWE) questionnaire and quality of life using SF-36 health survey questionnaire.Primary endpoint is number of scaphoid unions at six weeks, secondary endpoints are time interval to clinical and radiological consolidation, number of non-unions, functional status at 52 weeks and non-adherence to the treatment protocol. Netherlands Trial Register (NTR): NTR2064. © 2011 Hannemann et al; licensee BioMed Central Ltd.

Field trial of solvent-free emulsion in Oregon : final report.

DOT National Transportation Integrated Search

2003-03-01

This final report summarizes construction, laboratory and performance information gathered by ODOT personnel from a single field trial of solvent-free emulsion mix constructed in June 2001. The solvent-free emulsion mix presented several placement pr...

Competition Between Fusarium pseudograminearum and Cochliobolus sativus Observed in Field and Greenhouse Studies.

PubMed

Troth, Erin E Gunnink; Johnston, Jeffrey A; Dyer, Alan T

2018-02-01

Among root pathogens, one of the most documented antagonisms is the suppression of Cochliobolus sativus by Fusarium (roseum) species. Unfortunately, previous studies involved single isolates of each pathogen and thus, provided no indication of the spectrum of responses that occur across the respective species. To investigate the variability in interactions between Cochliobolus sativus and Fusarium pseudograminearum, field and greenhouse trials were conducted that included monitoring of spring wheat plant health and monitoring of pathogen populations via quantitative real-time polymerase chain reaction. The interactions between two isolates of C. sativus and four isolates of F. pseudograminearum were explored in three geographically distinct wheat fields. To complement field trials and to limit potentially confounding environmental variables that are often associated with field studies, greenhouse trials were performed that investigated the interactions among and between three isolates of C. sativus and four isolates of F. pseudograminearum. Across field locations, C. sativus isolate Cs2344 consistently and significantly reduced Fusarium populations by an average of 20.1%. Similarly, F. pseudograminearum isolate Fp2228 consistently and significantly reduced C. sativus field populations by an average of 30.9%. No interaction was detected in the field between pathogen species with regards to disease or crop losses. Greenhouse results confirmed a powerful (>99%), broadly effective suppression of Fusarium populations by isolate Cs2344. Among greenhouse trials, additional isolate-isolate interactions were observed affecting Fusarium populations. Due to lower C. sativus population sizes in greenhouse trials, significant Fusarium suppression of C. sativus was only detected in one isolate-isolate interaction. This study is the first to demonstrate suppression of Fusarium spp. by C. sativus in field and greenhouse settings. These findings also reveal a complex competitive interaction between these two pathogen species that was previously unknown.

Application of arbuscular mycorrhizal fungi with Pseudomonas aeruginosa UPMP3 reduces the development of Ganoderma basal stem rot disease in oil palm seedlings.

PubMed

Sundram, Shamala; Meon, Sariah; Seman, Idris Abu; Othman, Radziah

2015-07-01

The effect of arbuscular mycorrhizal fungi (AMF) in combination with endophytic bacteria (EB) in reducing development of basal stem rot (BSR) disease in oil palm (Elaeis guineensis) was investigated. BSR caused by Ganoderma boninense leads to devastating economic loss and the oil palm industry is struggling to control the disease. The application of two AMF with two EB as biocontrol agents was assessed in the nursery and subsequently, repeated in the field using bait seedlings. Seedlings pre-inoculated with a combination of Glomus intraradices UT126, Glomus clarum BR152B and Pseudomonas aeruginosa UPMP3 significantly reduced disease development measured as the area under disease progression curve (AUDPC) and the epidemic rate (R L) of disease in the nursery. A 20-month field trial using similar treatments evaluated disease development in bait seedlings based on the rotting area/advancement assessed in cross-sections of the seedling base. Data show that application of Glomus intraradices UT126 singly reduced disease development of BSR, but that combination of the two AMF with P. aeruginosa UPMP3 significantly improved biocontrol efficacy in both nursery and fields reducing BSR disease to 57 and 80%, respectively. The successful use of bait seedlings in the natural environment to study BSR development represents a promising alternative to nursery trial testing in the field with shorter temporal assessment.

Infrared Thermography Approach for Effective Shielding Area of Field Smoke Based on Background Subtraction and Transmittance Interpolation.

PubMed

Tang, Runze; Zhang, Tonglai; Chen, Yongpeng; Liang, Hao; Li, Bingyang; Zhou, Zunning

2018-05-06

Effective shielding area is a crucial indicator for the evaluation of the infrared smoke-obscuring effectiveness on the battlefield. The conventional methods for assessing the shielding area of the smoke screen are time-consuming and labor intensive, in addition to lacking precision. Therefore, an efficient and convincing technique for testing the effective shielding area of the smoke screen has great potential benefits in the smoke screen applications in the field trial. In this study, a thermal infrared sensor with a mid-wavelength infrared (MWIR) range of 3 to 5 μm was first used to capture the target scene images through clear as well as obscuring smoke, at regular intervals. The background subtraction in motion detection was then applied to obtain the contour of the smoke cloud at each frame. The smoke transmittance at each pixel within the smoke contour was interpolated based on the data that was collected from the image. Finally, the smoke effective shielding area was calculated, based on the accumulation of the effective shielding pixel points. One advantage of this approach is that it utilizes only one thermal infrared sensor without any other additional equipment in the field trial, which significantly contributes to the efficiency and its convenience. Experiments have been carried out to demonstrate that this approach can determine the effective shielding area of the field infrared smoke both practically and efficiently.

Yoga for Health Care in Korea: A Protocol for Systematic Review of Clinical Trials.

PubMed

Choi, Jiae; Jun, Ji Hee; Lee, Ju Ah; Lee, Myeong Soo

2016-08-01

This systematic review aims to evaluate the therapeutic effects of yoga therapy using an evidence-based approach and investigates the relationship between yoga and the meridian energies based on all available clinical studies in Korea. Sixteen electronic databases will be searched from the inception of the study until January 2016. All clinical evidences that evaluate any type of yoga and any type of control in individuals with any type of condition will be eligible. The methodological quality will be assessed using the Cochrane risk of bias tool for randomized clinical trials and the Newcastle-Ottawa scale for nonrandomized studies. Two authors will independently assess each study for eligibility and the risk of bias, and then they will extract the data. With its extensive, unbiased search of the Korean literature from various databases without any language restrictions, this systematic review will be useful for both practitioners in the field of yoga research as well as for patients. Copyright © 2016. Published by Elsevier B.V.

Design and evaluation of an aerial spray trial with true replicates to test the efficacy of Bacillus thuringiensis insecticide in a boreal forest.

PubMed

Cadogan, Beresford L; Scharbach, Roger D

2003-04-01

A field trial using true replicates was conducted successfully in a boreal forest in 1996 to evaluate the efficacy of two aerially applied Bacillus thuringiensis formulations, ABG 6429 and ABG 6430. A complete randomized design with four replicates per treatment was chosen. Twelve to 15 balsam fir (Abies balsamea [L.] Mill.) per plot were randomly selected as sample trees. Interplot buffer zones, > or = 200 m wide, adequately prevented cross contamination from sprays that were atomized with four rotary atomizers (volume median diameters ranging from 64.6 to 139.4 microm) and released approximately 30 m above the ground. The B. thuringiensis formulations were not significantly different (P > 0.05) from each other in reducing spruce budworm (Choristoneura fumiferana [Clem.]) populations and protecting balsam trees from defoliation but both formulations were significantly more efficacious than the controls. The results suggest that true replicates are a feasible alternative to pseudoreplication in experimental forest aerial applications.

Systemic and topical drugs for the prevention of HIV infection: antiretroviral pre-exposure prophylaxis

PubMed Central

Baeten, Jared; Celum, Connie

2013-01-01

Pre-exposure prophylaxis (PrEP), in which HIV uninfected persons use oral or topical antiretroviral medications to protect against HIV acquisition, is a promising new HIV prevention strategy. The biologic rationale for evaluation of PrEP for sexual HIV prevention included non-human primate models and antiretroviral prophylaxis for HIV-exposed infants. Proof-of-concept that PrEP protects against sexual HIV acquisition has been demonstrated in four clinical trials, which used the antiretroviral medication tenofovir, either as a vaginal gel or as daily oral tenofovir disoproxil fumarate, alone or co-formulated with emtricitabine. Importantly, however, two trials failed to demonstrate HIV protection with PrEP, with low adherence to daily use of PrEP the leading hypothesis for lack of efficacy. Next steps in the field include rigorous evaluation of uptake and adherence to PrEP in implementation settings and research into ‘next-generation’ PrEP agents with longer half-life and less user-dependence. PMID:23020883

Pharmacotherapy in the Management of Pediatric Obesity.

PubMed

Kelly, Aaron S; Fox, Claudia K

2017-08-01

This review provides a rationale for the use of pharmacotherapy in pediatric weight management, summarizes results of some of the key pediatric clinical trials of approved and "off-label" obesity medications, introduces new options in the pediatric pipeline, and offers a glimpse into the future of pediatric obesity medicine. Despite the need for adjunctive treatments to enhance the outcomes of lifestyle modification therapy among youth with obesity, none of the obesity medications evaluated to date have been shown to meaningfully reduce BMI or cardiometabolic risk factors. Promising medications recently approved for the treatment of obesity in adults will soon be tested in pediatric trials, offering hope that new therapeutic options will soon be available. As new medications are approved to treat pediatric obesity, it will be important to evaluate the safety and efficacy of combination pharmacotherapy and investigate predictors of response. Application of precision medicine approaches to the field of pediatric obesity management will improve the long-term outlook for the tens of millions of youth afflicted with this serious and recalcitrant disease.

An unattended verification station for UF 6 cylinders: Field trial findings

DOE PAGES

Smith, L. E.; Miller, K. A.; McDonald, B. S.; ...

2017-08-26

In recent years, the International Atomic Energy Agency (IAEA) has pursued innovative techniques and an integrated suite of safeguards measures to address the verification challenges posed by the front end of the nuclear fuel cycle. Among the unattended instruments currently being explored by the IAEA is an Unattended Cylinder Verification Station (UCVS), which could provide automated, independent verification of the declared relative enrichment, 235U mass, total uranium mass, and identification for all declared uranium hexafluoride cylinders in a facility (e.g., uranium enrichment plants and fuel fabrication plants). Under the auspices of the United States and European Commission Support Programs tomore » the IAEA, a project was undertaken to assess the technical and practical viability of the UCVS concept. The first phase of the UCVS viability study was centered on a long-term field trial of a prototype UCVS system at a fuel fabrication facility. A key outcome of the study was a quantitative performance evaluation of two nondestructive assay (NDA) methods being considered for inclusion in a UCVS: Hybrid Enrichment Verification Array (HEVA), and Passive Neutron Enrichment Meter (PNEM). This paper provides a description of the UCVS prototype design and an overview of the long-term field trial. In conclusion, analysis results and interpretation are presented with a focus on the performance of PNEM and HEVA for the assay of over 200 “typical” Type 30B cylinders, and the viability of an “NDA Fingerprint” concept as a high-fidelity means to periodically verify that material diversion has not occurred.« less

An unattended verification station for UF 6 cylinders: Field trial findings

DOE Office of Scientific and Technical Information (OSTI.GOV)

Smith, L. E.; Miller, K. A.; McDonald, B. S.

In recent years, the International Atomic Energy Agency (IAEA) has pursued innovative techniques and an integrated suite of safeguards measures to address the verification challenges posed by the front end of the nuclear fuel cycle. Among the unattended instruments currently being explored by the IAEA is an Unattended Cylinder Verification Station (UCVS), which could provide automated, independent verification of the declared relative enrichment, 235U mass, total uranium mass, and identification for all declared uranium hexafluoride cylinders in a facility (e.g., uranium enrichment plants and fuel fabrication plants). Under the auspices of the United States and European Commission Support Programs tomore » the IAEA, a project was undertaken to assess the technical and practical viability of the UCVS concept. The first phase of the UCVS viability study was centered on a long-term field trial of a prototype UCVS system at a fuel fabrication facility. A key outcome of the study was a quantitative performance evaluation of two nondestructive assay (NDA) methods being considered for inclusion in a UCVS: Hybrid Enrichment Verification Array (HEVA), and Passive Neutron Enrichment Meter (PNEM). This paper provides a description of the UCVS prototype design and an overview of the long-term field trial. In conclusion, analysis results and interpretation are presented with a focus on the performance of PNEM and HEVA for the assay of over 200 “typical” Type 30B cylinders, and the viability of an “NDA Fingerprint” concept as a high-fidelity means to periodically verify that material diversion has not occurred.« less

ELECTROCHEMICAL ARSENIC REMEDIATION IN RURAL BANGLADESH

EPA Science Inventory

In Year 1, we built a bench-scale continuous flow prototype (dubbed “Sushi” for its sushi-like electrode roll) and completed preliminary field trials in Bangladesh. We were also able to leverage additional funding to complete preliminary field trials in arsenic-...

Development and reproducibility evaluation of a Monte Carlo-based standard LINAC model for quality assurance of multi-institutional clinical trials.

PubMed

Usmani, Muhammad Nauman; Takegawa, Hideki; Takashina, Masaaki; Numasaki, Hodaka; Suga, Masaki; Anetai, Yusuke; Kurosu, Keita; Koizumi, Masahiko; Teshima, Teruki

2014-11-01

Technical developments in radiotherapy (RT) have created a need for systematic quality assurance (QA) to ensure that clinical institutions deliver prescribed radiation doses consistent with the requirements of clinical protocols. For QA, an ideal dose verification system should be independent of the treatment-planning system (TPS). This paper describes the development and reproducibility evaluation of a Monte Carlo (MC)-based standard LINAC model as a preliminary requirement for independent verification of dose distributions. The BEAMnrc MC code is used for characterization of the 6-, 10- and 15-MV photon beams for a wide range of field sizes. The modeling of the LINAC head components is based on the specifications provided by the manufacturer. MC dose distributions are tuned to match Varian Golden Beam Data (GBD). For reproducibility evaluation, calculated beam data is compared with beam data measured at individual institutions. For all energies and field sizes, the MC and GBD agreed to within 1.0% for percentage depth doses (PDDs), 1.5% for beam profiles and 1.2% for total scatter factors (Scps.). Reproducibility evaluation showed that the maximum average local differences were 1.3% and 2.5% for PDDs and beam profiles, respectively. MC and institutions' mean Scps agreed to within 2.0%. An MC-based standard LINAC model developed to independently verify dose distributions for QA of multi-institutional clinical trials and routine clinical practice has proven to be highly accurate and reproducible and can thus help ensure that prescribed doses delivered are consistent with the requirements of clinical protocols. © The Author 2014. Published by Oxford University Press on behalf of The Japan Radiation Research Society and Japanese Society for Radiation Oncology.

A systematic review of the effect of pre-test rest duration on toe and ankle systolic blood pressure measurements

PubMed Central

2014-01-01

Background Measurement of toe and ankle blood pressure is commonly used to evaluate peripheral vascular status, yet the pre-test rest period is inconsistent in published studies and among practitioners, and could affect results. The aim of this systematic review is to evaluate all research that has investigated the effect of different periods of pre-test rest on toe and ankle systolic blood pressure. Methods The following databases were searched up to April 2012: Medline (from 1946), EMBASE (from 1947), CINAHL (from 1937), and Cochrane Central Register of Controlled Trials (CENTRAL) (from 1800). No language or publication restrictions were applied. Eighty-eight content experts and researchers in the field were contacted by email to assist in the identification of published, unpublished, and ongoing studies. Studies evaluating the effect of two or more pre-test rest durations on toe or ankle systolic blood pressure were eligible for inclusion. No restrictions were placed on participant characteristics or the method of blood pressure measurement. Outcomes included toe or ankle systolic blood pressure and adverse effects. Abstracts identified from the search terms were independently assessed by two reviewers for potential inclusion. Results 1658 abstracts were identified by electronic searching. Of the 88 content experts and researchers in the field contacted by email a total of 33 replied and identified five potentially relevant studies. No studies were eligible for inclusion. Conclusions There is no evidence of the effect of different periods of pre-test rest duration on toe and ankle systolic blood pressure measurements. Rigorous trials evaluating the effect of different durations of pre-test rest are required to direct clinical practice and research. PMID:24708870

Overview of phase IV clinical trials for postmarket drug safety surveillance: a status report from the ClinicalTrials.gov registry.

PubMed

Zhang, Xinji; Zhang, Yuan; Ye, Xiaofei; Guo, Xiaojing; Zhang, Tianyi; He, Jia

2016-11-23

Phase IV trials are often used to investigate drug safety after approval. However, little is known about the characteristics of contemporary phase IV clinical trials and whether these studies are of sufficient quality to advance medical knowledge in pharmacovigilance. We aimed to determine the fundamental characteristics of phase IV clinical trials that evaluated drug safety using the ClinicalTrials.gov registry data. A data set of 19 359 phase IV clinical studies registered in ClinicalTrials.gov was downloaded. The characteristics of the phase IV trials focusing on safety only were compared with those evaluating both safety and efficacy. We also compared the characteristics of the phase IV trials in three major therapeutic areas (cardiovascular diseases, mental health and oncology). Multivariable logistic regression was used to evaluate factors associated with the use of blinding and randomisation. A total of 4772 phase IV trials were identified, including 330 focusing on drug safety alone and 4392 evaluating both safety and efficacy. Most of the phase IV trials evaluating drug safety (75.9%) had enrolment <300 with 96.5% <3000. Among these trials, 8.2% were terminated or withdrawn. Factors associated with the use of blinding and randomisation included the intervention model, clinical specialty and lead sponsor. Phase IV trials evaluating drug safety in the ClinicalTrials.gov registry were dominated by small trials that might not have sufficient power to detect less common adverse events. An adequate sample size should be emphasised for phase IV trials with safety surveillance as main task. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Review of ongoing clinical trials in non-small-cell lung cancer: a status report for 2012 from the ClinicalTrials.gov Web site.

PubMed

Subramanian, Janakiraman; Regenbogen, Thomas; Nagaraj, Gayathri; Lane, Alex; Devarakonda, Siddhartha; Zhou, Gongfu; Govindan, Ramaswamy

2013-07-01

Clinical research in non-small-cell lung cancer (NSCLC) is a rapidly evolving field. In an effort to identify the current trends in lung cancer clinical research, we reviewed ongoing clinical trials in NSCLC listed in the ClinicalTrials.gov registry in 2012, and we also compared this data to a similar survey conducted by us in 2009. The Web site's advanced search function was used to search for the term "non-small cell lung cancer." The search was further refined by using the following options from the search page drop-down menu, "open studies" and "interventional." Studies with non-NSCLC tumor histologies and pediatric studies were excluded. Of the 477 trials included in the analysis, 105 (22.0%) were phase I, 223 phase II (46.8%), and 63 phase III trials (13.2%). When compared with data from 2009, university-sponsored trials decreased in number (45.4%-34.2%; p < 0.001) whereas industry-sponsored trials remained almost the same. There was a significant increase in trials conducted exclusively outside of the United States (35.9%-48.8%; p = 0.001). The number of studies with locations in China (61, 12.8%) was second only to that in the United States (244, 51.2%). Studies reporting biomarker analysis increased significantly from 37.5% to 49.1% in 2012 (p < 0.001). Biomarker-based patient selection also increased significantly from 7.9% to 25.8% (p < 0.001). Targeted therapies were evaluated in 70.6% of phase I/II and II trials, and the most common class of targeted agent studied was epidermal growth factor receptor tyrosine kinase inhibitors (38.0%). Prespecified accrual times were observed to increase when compared with data reported in 2009, especially among industry-sponsored studies. Our survey identified major changes in lung cancer clinical research since 2009. Almost half of all studies registered at the ClinicalTrials.gov Web site are being conducted outside the United States, and several novel molecularly targeted agents are being evaluated in the treatment of patients with NSCLC. More importantly, we identified a threefold increase in the number of studies that perform biomarker testing to determine patient selection over the last 3 years.

Multiple-micronutrient supplementation for women during pregnancy.

PubMed

Haider, Batool A; Bhutta, Zulfiqar A

2012-11-14

Multiple-micronutrient deficiencies often coexist in low- to middle-income countries. They are exacerbated in pregnancy due to the increased demands, leading to potentially adverse effects on the mother. Substantive evidence regarding the effectiveness of multiple-micronutrient supplements (MMS) during pregnancy is not available. To evaluate the benefits to both mother and infant of multiple-micronutrient supplements in pregnancy and to assess the risk of adverse events as a result of supplementation. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (17 February 2012) and reference lists of retrieved articles and key reviews. We also contacted experts in the field for additional and ongoing trials. All prospective randomised controlled trials evaluating multiple-micronutrient supplementation during pregnancy and its effects on the pregnancy outcome, irrespective of language or publication status of the trials. We included cluster-randomised trials but quasi-randomised trials were excluded. Two review authors independently assessed trials for inclusion and trial quality. Two review authors independently extracted the data. Data were checked for accuracy. Twenty-three trials (involving 76,532 women) were identified as eligible for inclusion in this review but only 21 trials (involving 75,785 women) contributed data to the review.When compared with iron and folate supplementation, MMS resulted in a statistically significant decrease in the number of low birthweight babies (risk ratio (RR) 0.89; 95% confidence interval (CI) 0.83 to 0.94) and small-for-gestational age (SGA) babies (RR 0.87; 95% CI 0.81 to 0.95). No statistically significant differences were shown for other maternal and pregnancy outcomes: preterm births RR 0.99 (95% CI 0.96 to 1.02), miscarriage RR 0.90 (95% CI 0.79 to 1.02), maternal mortality RR 0.97 (95% CI 0.63 to 1.48), perinatal mortality RR 0.99 (95% CI 0.84 to 1.16), stillbirths RR 0.96 (95% CI 0.86 to 1.07) and neonatal mortality RR 1.01 (95% CI 0.89 to 1.15).A number of prespecified clinically important outcomes could not be assessed due to insufficient or non-available data. These include placental abruption, congenital anomalies including neural tube defects, premature rupture of membranes, neurodevelopmental delay, very preterm births, cost of supplementation, side-effects of supplements, maternal well being or satisfaction, and nutritional status of children. Though multiple micronutrients have been found to have a significant beneficial impact on SGA and low birthweight babies, we still need more evidence to guide a universal policy change and to suggest replacement of routine iron and folate supplementation with a MMS. Future trials should be adequately powered to evaluate the effects on mortality and other morbidity outcomes. Trials should also assess the effect of variability between different combinations and dosages of micronutrients, keeping within the safe recommended levels. In regions with deficiency of a single micronutrient, evaluation of each micronutrient against a placebo in women already receiving iron with folic acid would be especially useful in justifying the inclusion of that micronutrient in routine antenatal care.

Developing evaluation instrument based on CIPP models on the implementation of portfolio assessment

NASA Astrophysics Data System (ADS)

Kurnia, Feni; Rosana, Dadan; Supahar

2017-08-01

This study aimed to develop an evaluation instrument constructed by CIPP model on the implementation of portfolio assessment in science learning. This study used research and development (R & D) method; adapting 4-D by the development of non-test instrument, and the evaluation instrument constructed by CIPP model. CIPP is the abbreviation of Context, Input, Process, and Product. The techniques of data collection were interviews, questionnaires, and observations. Data collection instruments were: 1) the interview guidelines for the analysis of the problems and the needs, 2) questionnaire to see level of accomplishment of portfolio assessment instrument, and 3) observation sheets for teacher and student to dig up responses to the portfolio assessment instrument. The data obtained was quantitative data obtained from several validators. The validators consist of two lecturers as the evaluation experts, two practitioners (science teachers), and three colleagues. This paper shows the results of content validity obtained from the validators and the analysis result of the data obtained by using Aikens' V formula. The results of this study shows that the evaluation instrument based on CIPP models is proper to evaluate the implementation of portfolio assessment instruments. Based on the experts' judgments, practitioners, and colleagues, the Aikens' V coefficient was between 0.86-1,00 which means that it is valid and can be used in the limited trial and operational field trial.

76 FR 38037 - Mevinphos; Data Call-in Order for Pesticide Tolerances

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-29

... residues of mevinphos on the following commodities: Broccoli, cabbage, cauliflower, celery, spinach... Field Trials (860.1500)--(broccoli, cabbage, cauliflower, celery, grapes, lettuce, peas, peppers... Not required October 1, 2012. 860.1500 Crop Field Trials Not Required September 30, 2013. (broccoli...

Evaluating biomarkers for prognostic enrichment of clinical trials.

PubMed

Kerr, Kathleen F; Roth, Jeremy; Zhu, Kehao; Thiessen-Philbrook, Heather; Meisner, Allison; Wilson, Francis Perry; Coca, Steven; Parikh, Chirag R

2017-12-01

A potential use of biomarkers is to assist in prognostic enrichment of clinical trials, where only patients at relatively higher risk for an outcome of interest are eligible for the trial. We investigated methods for evaluating biomarkers for prognostic enrichment. We identified five key considerations when considering a biomarker and a screening threshold for prognostic enrichment: (1) clinical trial sample size, (2) calendar time to enroll the trial, (3) total patient screening costs and the total per-patient trial costs, (4) generalizability of trial results, and (5) ethical evaluation of trial eligibility criteria. Items (1)-(3) are amenable to quantitative analysis. We developed the Biomarker Prognostic Enrichment Tool for evaluating biomarkers for prognostic enrichment at varying levels of screening stringency. We demonstrate that both modestly prognostic and strongly prognostic biomarkers can improve trial metrics using Biomarker Prognostic Enrichment Tool. Biomarker Prognostic Enrichment Tool is available as a webtool at http://prognosticenrichment.com and as a package for the R statistical computing platform. In some clinical settings, even biomarkers with modest prognostic performance can be useful for prognostic enrichment. In addition to the quantitative analysis provided by Biomarker Prognostic Enrichment Tool, investigators must consider the generalizability of trial results and evaluate the ethics of trial eligibility criteria.

METHODOLOGICAL QUALITY OF ECONOMIC EVALUATIONS ALONGSIDE TRIALS OF KNEE PHYSIOTHERAPY.

PubMed

García-Pérez, Lidia; Linertová, Renata; Arvelo-Martín, Alejandro; Guerra-Marrero, Carolina; Martínez-Alberto, Carlos Enrique; Cuéllar-Pompa, Leticia; Escobar, Antonio; Serrano-Aguilar, Pedro

2017-01-01

The methodological quality of an economic evaluation performed alongside a clinical trial can be underestimated if the paper does not report key methodological features. This study discusses methodological assessment issues on the example of a systematic review on cost-effectiveness of physiotherapy for knee osteoarthritis. Six economic evaluation studies included in the systematic review and related clinical trials were assessed using the 10-question check-list by Drummond and the Physiotherapy Evidence Database (PEDro) scale. All economic evaluations were performed alongside a clinical trial but the studied interventions were too heterogeneous to be synthesized. Methodological quality of the economic evaluations reported in the papers was not free of drawbacks, and in some cases, it improved when information from the related clinical trial was taken into account. Economic evaluation papers dedicate little space to methodological features of related clinical trials; therefore, the methodological quality can be underestimated if evaluated separately from the trials. Future economic evaluations should follow more strictly the recommendations about methodology and the authors should pay special attention to the quality of reporting.

Viability Study for an Unattended UF 6 Cylinder Verification Station: Phase I Final Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Smith, Leon E.; Miller, Karen A.; Garner, James R.

In recent years, the International Atomic Energy Agency (IAEA) has pursued innovative techniques and an integrated suite of safeguards measures to address the verification challenges posed by the front end of the nuclear fuel cycle. Among the unattended instruments currently being explored by the IAEA is an Unattended Cylinder Verification Station (UCVS) that could provide automated, independent verification of the declared relative enrichment, 235U mass, total uranium mass and identification for all declared UF 6 cylinders in a facility (e.g., uranium enrichment plants and fuel fabrication plants). Under the auspices of the United States and European Commission Support Programs tomore » the IAEA, a project was undertaken to assess the technical and practical viability of the UCVS concept. The US Support Program team consisted of Pacific Northwest National Laboratory (PNNL, lead), Los Alamos National Laboratory (LANL), Oak Ridge National Laboratory (ORNL) and Savanah River National Laboratory (SRNL). At the core of the viability study is a long-term field trial of a prototype UCVS system at a Westinghouse fuel fabrication facility. A key outcome of the study is a quantitative performance evaluation of two nondestructive assay (NDA) methods being considered for inclusion in a UCVS: Hybrid Enrichment Verification Array (HEVA), and Passive Neutron Enrichment Meter (PNEM). This report provides context for the UCVS concept and the field trial: potential UCVS implementation concepts at an enrichment facility; an overview of UCVS prototype design; field trial objectives and activities. Field trial results and interpretation are presented, with a focus on the performance of PNEM and HEVA for the assay of over 200 “typical” Type 30B cylinders, and the viability of an “NDA Fingerprint” concept as a high-fidelity means to periodically verify that the contents of a given cylinder are consistent with previous scans. A modeling study, combined with field-measured instrument uncertainties, provides an assessment of the partial-defect sensitivity of HEVA and PNEM for both one-time assay and (repeated) NDA Fingerprint verification scenarios. The findings presented in this report represent a significant step forward in the community’s understanding of the strengths and limitations of the PNEM and HEVA NDA methods, and the viability of the UCVS concept in front-end fuel cycle facilities. This experience will inform Phase II of the UCVS viability study, should the IAEA pursue it.« less

Novel Control Scheme of Power Assisted Wheelchair for Preventing Overturn (Part I)-Adjustment of Assisted Torque and Performance Evaluation From Field Test-

NASA Astrophysics Data System (ADS)

Seki, Hirokazu; Hata, Naoki; Koyasu, Yuichi; Hori, Yoichi

Aged people and disabled people who have difficulty in walking are increasing. As one of mobility support, significance of power assisted wheelchair which assists driving force using electric motors and spreads their living areas has been enhanced. However, the increased driving force often causes a dangerous overturn of wheelchair. In this paper, control method to prevent power assisted wheelchair from overturning is proposed. It is found the front wheels rising is caused by magnitude and rapid increase of assisted torque. Therefore, feedforward control method to limit the assisted torque by tuning its magnitude or time constant is proposed. In order to emphasize safety and feeling of security, these methods make the front wheels no rise. The effectiveness of the proposed method is verified by the practical experiments and field test based performance evaluation using many trial subjects.

A Quantitative Evaluation of Dissolved Oxygen Instrumentation

NASA Technical Reports Server (NTRS)

Pijanowski, Barbara S.

1971-01-01

The implications of the presence of dissolved oxygen in water are discussed in terms of its deleterious or beneficial effects, depending on the functional consequences to those affected, e.g., the industrialist, the oceanographer, and the ecologist. The paper is devoted primarily to an examination of the performance of five commercially available dissolved oxygen meters. The design of each is briefly reviewed and ease or difficulty of use in the field described. Specifically, the evaluation program treated a number of parameters and user considerations including an initial check and trial calibration for each instrument and a discussion of the measurement methodology employed. Detailed test results are given relating to the effects of primary power variation, water-flow sensitivity, response time, relative accuracy of dissolved-oxygen readout, temperature accuracy (for those instruments which included this feature), error and repeatability, stability, pressure and other environmental effects, and test results obtained in the field. Overall instrument performance is summarized comparatively by chart.

Two field trials for deblending of simultaneous source surveys: Why we failed and why we succeeded?

NASA Astrophysics Data System (ADS)

Zu, Shaohuan; Zhou, Hui; Chen, Haolin; Zheng, Hao; Chen, Yangkang

2017-08-01

Currently, deblending is the main strategy for dealing with the intense interference problem of simultaneous source data. Most deblending methods are based on the property that useful signal is coherent while the interference is incoherent in some domains other than common shot domain. In this paper, two simultaneous source field trials were studied in detail. In the first trial, the simultaneous source survey was not optimal, as the dithering code had strong coherency and the minimum distance between the two vessels was also small. The chosen marine shot scheduling and vessel deployment made it difficult to deblend the simultaneous source data, and result was an unexpected failure. Next, we tested different parameters (the dithering code and the minimum distance between vessels) of the simultaneous source survey using the simulated blended data and got some useful insights. Then, we carried out the second field trial with a carefully designed survey that was much different from the first trial. The deblended results in common receiver gather, common shot gather or the final stacked profile were encouraging. We obtained a complete success in the second field trial, which gave us confidence in the further test (such as a full three dimensional acquisition test or a high-resolution acquisition test with denser spatial sampling). Remembering that failures with simultaneous sourcing seldom reported, in this paper, our contribution is the discussion in detail about both our failed and successful field experiments and the lessons we have learned from them with the hope that the experience gained from this study can be very useful to other researchers in the same field.

Oncology trial abstracts showed suboptimal improvement in reporting: a comparative before-and-after evaluation using CONSORT for Abstract guidelines.

PubMed

Ghimire, Saurav; Kyung, Eunjung; Lee, Heeyoung; Kim, Eunyoung

2014-06-01

The aims of this study were to evaluate the quality of randomized controlled trial (RCT) abstracts published in the field of oncology and identify characteristics associated with better reporting quality. All phase III trials published during 2005-2007 [before Consolidated Standards of Reporting Trials (CONSORT)] and 2010-2012 (after CONSORT) were searched electronically in MEDLINE/PubMed and retrieved for review using an 18-point overall quality score (OQS) for reporting based on the CONSORT for Abstract guidelines. Descriptive statistics followed by multivariate linear regression were used to identify features associated with improved reporting quality. The mean OQS was 8.2 (range: 5-13; 95% confidence interval (CI): 8.0, 8.3) and 9.9 (range: 5-18; 95% CI: 9.7, 10.2) in the pre- and post-CONSORT periods, respectively. The method for random sequence generation, allocation concealment, blinding details, and funding sources were missing in pre-CONSORT abstracts and insufficiently reported (<20%) in post-CONSORT abstracts. A high impact factor (P < 0.001) and the journal of publication (P < 0.001) were independent factors that were significantly associated with higher reporting quality on multivariate analysis. The reporting quality of RCT abstracts in oncology showed suboptimal improvement over time. Thus, stricter adherence to the CONSORT for Abstract guidelines is needed to improve the reporting quality of RCT abstracts published in oncology. Copyright © 2014 Elsevier Inc. All rights reserved.

Efficient design and inference for multistage randomized trials of individualized treatment policies.

PubMed

Dawson, Ree; Lavori, Philip W

2012-01-01

Clinical demand for individualized "adaptive" treatment policies in diverse fields has spawned development of clinical trial methodology for their experimental evaluation via multistage designs, building upon methods intended for the analysis of naturalistically observed strategies. Because often there is no need to parametrically smooth multistage trial data (in contrast to observational data for adaptive strategies), it is possible to establish direct connections among different methodological approaches. We show by algebraic proof that the maximum likelihood (ML) and optimal semiparametric (SP) estimators of the population mean of the outcome of a treatment policy and its standard error are equal under certain experimental conditions. This result is used to develop a unified and efficient approach to design and inference for multistage trials of policies that adapt treatment according to discrete responses. We derive a sample size formula expressed in terms of a parametric version of the optimal SP population variance. Nonparametric (sample-based) ML estimation performed well in simulation studies, in terms of achieved power, for scenarios most likely to occur in real studies, even though sample sizes were based on the parametric formula. ML outperformed the SP estimator; differences in achieved power predominately reflected differences in their estimates of the population mean (rather than estimated standard errors). Neither methodology could mitigate the potential for overestimated sample sizes when strong nonlinearity was purposely simulated for certain discrete outcomes; however, such departures from linearity may not be an issue for many clinical contexts that make evaluation of competitive treatment policies meaningful.

Improving the development, monitoring and reporting of stroke rehabilitation research: Consensus-based core recommendations from the Stroke Recovery and Rehabilitation Roundtable.

PubMed

Walker, Marion F; Hoffmann, Tammy C; Brady, Marian C; Dean, Catherine M; Eng, Janice J; Farrin, Amanda J; Felix, Cynthia; Forster, Anne; Langhorne, Peter; Lynch, Elizabeth A; Radford, Kathryn A; Sunnerhagen, Katharina S; Watkins, Caroline L

2017-07-01

Recent reviews have demonstrated that the quality of stroke rehabilitation research has continued to improve over the last four decades but despite this progress, there are still many barriers in moving the field forward. Rigorous development, monitoring and complete reporting of interventions in stroke trials are essential in providing rehabilitation evidence that is robust, meaningful and implementable. An international partnership of stroke rehabilitation experts committed to develop consensus-based core recommendations with a remit of addressing the issues identified as limiting stroke rehabilitation research in the areas of developing, monitoring and reporting stroke rehabilitation interventions. Work exploring each of the three areas took place via multiple teleconferences and a two-day meeting in Philadelphia in May 2016. A total of 15 recommendations were made. To validate the need for the recommendations, the group reviewed all stroke rehabilitation trials published in 2015 (n = 182 papers). Our review highlighted that the majority of publications did not clearly describe how interventions were developed or monitored during the trial. In particular, under-reporting of the theoretical rationale for the intervention and the components of the intervention call into question many interventions that have been evaluated for efficacy. More trials were found to have addressed the reporting of interventions recommendations than those related to development or monitoring. Nonetheless, the majority of reporting recommendations were still not adequately described. To progress the field of stroke rehabilitation research and to ensure stroke patients receive optimal evidence-based clinical care, we urge the research community to endorse and adopt our recommendations.

Evaluation of Physical Coverings Used To Control Escherichia coli O157:H7 at the Compost Heap Surface ▿ †

PubMed Central

Shepherd, Marion W.; Kim, Jinkyung; Jiang, Xiuping; Doyle, Michael P.; Erickson, Marilyn C.

2011-01-01

Throughout four field trials, compost heaps covered with finished compost maintained temperatures under the physical covering that were ca. 7 to 15.5°C higher, resulting in rapid Escherichia coli O157:H7 reduction, than those of the heaps covered with fresh straw or left uncovered. Our results validated recommendations made by the U.S. Environmental Protection Agency for covering fresh compost. PMID:21622780

Evaluation of Bt Corn with Pyramided Genes on Efficacy and Insect Resistance Management for the Asian Corn Borer in China.

PubMed

Jiang, Fan; Zhang, Tiantao; Bai, Shuxiong; Wang, Zhenying; He, Kanglai

2016-01-01

A Bt corn hybrid (AcIe) with two Bt genes (cry1Ie and cry1Ac) was derived by breeding stack from line expressing Cry1Ie and a line expressing Cry1Ac. Efficacy of this pyramided Bt corn hybrid against the Asian corn borer (ACB), Ostrinia furnacalis, was evaluated. We conducted laboratory bioassays using susceptible and resistant ACB strains fed on artificial diet or fresh plant tissues. We also conducted field trials with artificial infestations of ACB neonates at the V6 and silk stages. The toxin-diet bioassay data indicated that mixtures of Cry1Ac and Cry1Ie proteins had synergistic insecticidal efficacy. The plant tissue bioassay data indicated that Bt corn hybrids expressing either a single toxin (Cry1Ac or Cry1Ie) or two toxins had high efficacy against susceptible ACB. Damage ratings in the field trials indicated that the Bt corn hybrids could effectively protect against 1st and the 2nd generation ACB in China. The hybrid line with two Bt genes showed a higher efficacy against ACB larvae resistant to Cry1Ac or CryIe than the hybrid containing one Bt gene, and the two gene hybrid would have increased potential for managing or delaying the evolution of ACB resistance to Bt corn plants.

Choice of Grating Orientation for Evaluation of Peripheral Vision

PubMed Central

Venkataraman, Abinaya Priya; Winter, Simon; Rosén, Robert; Lundström, Linda

2016-01-01

ABSTRACT Purpose Peripheral resolution acuity depends on the orientation of the stimuli. However, it is uncertain if such a meridional effect also exists for peripheral detection tasks because they are affected by optical errors. Knowledge of the quantitative differences in acuity for different grating orientations is crucial for choosing the appropriate stimuli for evaluations of peripheral resolution and detection tasks. We assessed resolution and detection thresholds for different grating orientations in the peripheral visual field. Methods Resolution and detection thresholds were evaluated for gratings of four different orientations in eight different visual field meridians in the 20-deg visual field in white light. Detection measurements in monochromatic light (543 nm; bandwidth, 10 nm) were also performed to evaluate the effects of chromatic aberration on the meridional effect. A combination of trial lenses and adaptive optics system was used to correct the monochromatic lower- and higher-order aberrations. Results For both resolution and detection tasks, gratings parallel to the visual field meridian had better threshold compared with the perpendicular gratings, whereas the two oblique gratings had similar thresholds. The parallel and perpendicular grating acuity differences for resolution and detection tasks were 0.16 logMAR and 0.11 logMAD, respectively. Elimination of chromatic errors did not affect the meridional preference in detection acuity. Conclusions Similar to peripheral resolution, detection also shows a meridional effect that appears to have a neural origin. The threshold difference seen for parallel and perpendicular gratings suggests the use of two oblique gratings as stimuli in alternative forced-choice procedures for peripheral vision evaluation to reduce measurement variation. PMID:26889822

Choice of Grating Orientation for Evaluation of Peripheral Vision.

PubMed

Venkataraman, Abinaya Priya; Winter, Simon; Rosén, Robert; Lundström, Linda

2016-06-01

Peripheral resolution acuity depends on the orientation of the stimuli. However, it is uncertain if such a meridional effect also exists for peripheral detection tasks because they are affected by optical errors. Knowledge of the quantitative differences in acuity for different grating orientations is crucial for choosing the appropriate stimuli for evaluations of peripheral resolution and detection tasks. We assessed resolution and detection thresholds for different grating orientations in the peripheral visual field. Resolution and detection thresholds were evaluated for gratings of four different orientations in eight different visual field meridians in the 20-deg visual field in white light. Detection measurements in monochromatic light (543 nm; bandwidth, 10 nm) were also performed to evaluate the effects of chromatic aberration on the meridional effect. A combination of trial lenses and adaptive optics system was used to correct the monochromatic lower- and higher-order aberrations. For both resolution and detection tasks, gratings parallel to the visual field meridian had better threshold compared with the perpendicular gratings, whereas the two oblique gratings had similar thresholds. The parallel and perpendicular grating acuity differences for resolution and detection tasks were 0.16 logMAR and 0.11 logMAD, respectively. Elimination of chromatic errors did not affect the meridional preference in detection acuity. Similar to peripheral resolution, detection also shows a meridional effect that appears to have a neural origin. The threshold difference seen for parallel and perpendicular gratings suggests the use of two oblique gratings as stimuli in alternative forced-choice procedures for peripheral vision evaluation to reduce measurement variation.

The OPERA trial: a protocol for the process evaluation of a randomised trial of an exercise intervention for older people in residential and nursing accommodation

PubMed Central

2011-01-01

Background The OPERA trial is large cluster randomised trial testing a physical activity intervention to address depression amongst people living in nursing and residential homes for older people. A process evaluation was commissioned alongside the trial and we report the protocol for this process evaluation. Challenges included the cognitive and physical ability of the participants, the need to respect the privacy of all home residents, including study non-participants, and the physical structure of the homes. Evaluation activity had to be organised around the structured timetable of homes, leaving limited opportunities for data collection. The aims of this process evaluation are to provide findings that will assist in the interpretation of the clinical trial results, and to inform potential implementation of the physical activity intervention on a wider scale. Methods/design Quantitative data on recruitment of homes and individuals is being collected. For homes in the intervention arm, data on dose and fidelity of the intervention delivered; including individual rates of participation in exercise classes are collected. In the control homes, uptake and delivery of depression awareness training is monitored. These data will be combined with qualitative data from an in-depth study of a purposive sample of eight homes (six intervention and two control). Discussion Although process evaluations are increasingly funded alongside trials, it is still rare to see the findings published, and even rarer to see the protocol for such an evaluation published. Process evaluations have the potential to assist in interpreting and understanding trial results as well as informing future roll-outs of interventions. If such evaluations are funded they should also be reported and reviewed in a similar way to the trial outcome evaluation. Trial Registration ISRCTN No: ISRCTN43769277 PMID:21288341

Coapplication of Chicken Litter Biochar and Urea Only to Improve Nutrients Use Efficiency and Yield of Oryza sativa L. Cultivation on a Tropical Acid Soil

PubMed Central

Maru, Ali; Haruna, Osumanu Ahmed; Charles Primus, Walter

2015-01-01

The excessive use of nitrogen (N) fertilizers in sustaining high rice yields due to N dynamics in tropical acid soils not only is economically unsustainable but also causes environmental pollution. The objective of this study was to coapply biochar and urea to improve soil chemical properties and productivity of rice. Biochar (5 t ha−1) and different rates of urea (100%, 75%, 50%, 25%, and 0% of recommended N application) were evaluated in both pot and field trials. Selected soil chemical properties, rice plants growth variables, nutrient use efficiency, and yield were determined using standard procedures. Coapplication of biochar with 100% and 75% urea recommendation rates significantly increased nutrients availability (especially P and K) and their use efficiency in both pot and field trials. These treatments also significantly increased rice growth variables and grain yield. Coapplication of biochar and urea application at 75% of the recommended rate can be used to improve soil chemical properties and productivity and reduce urea use by 25%. PMID:26273698

Evaluation of hydrocarbon plants suitable for cultivation in Florida. [Euphorbia tirucalli, E. lathyris, and Asclepias curassavica

DOE Office of Scientific and Technical Information (OSTI.GOV)

Dehgan, B.; Wang, S.C.

1983-01-01

Most of the hydrocarbon plants reported in the literature are not suitable for cultivation under Florida conditions. Preliminary results of field and greenhouse trials have indicated two species; Euphorbia tirucalli, which is suitable only for south Florida and Asclepias curassavica which has shown promise for the entire state. The hydrocarbon content of E. tirucalli increases with age of the plants (8.19-11.90%), whereas, that of A. curassavica is influenced positively by fertilization (3.62%) and negatively by supplemental irrigation (2.75%). A comparison between the results of field trials with A. curassavica in Florida and E. lathyris in California shows similar biomass yieldsmore » under unirrigated conditions, despite 3.6 to 7.8 times greater nitrogen application for E. lathyris. Because of environmental conditions in Florida, E. lathyris is not capable of good growth. It is suggested that future research on hydrocarbon plants should concentrate on selection of individuals or species with vigorous, upright growth habits, low fertilizer-irrigation requirements and high hydrocarbon contents. 18 references.« less

Field evaluation of the efficacy of Mycobacterium bovis BCG vaccine against tuberculosis in goats.

PubMed

Vidal, Enric; Arrieta-Villegas, Claudia; Grasa, Miriam; Mercader, Irene; Domingo, Mariano; Pérez de Val, Bernat

2017-08-17

Control of animal tuberculosis (TB) through vaccination has emerged as a long-term strategy to complement test and slaughter control strategy. A pilot trial under field conditions was conducted in a goat herd with high TB prevalence to assess the efficacy of the Mycobacterium bovis BCG vaccine. Twenty-three goat kids vaccinated with BCG and other 22 unvaccinated control kids were euthanized at 18 months post-vaccination. Gross pathological and histopathological examination of target tissues was performed for detection of tuberculous lesions and assessment of vaccine efficacy. Mycobacterial culture and DNA detection were used to confirm Mycobacterium caprae infection. Vaccination significantly reduced the number of animals with TB lesions compared to unvaccinated controls (35% and 77%, respectively; P < 0.01). This reduction was even higher if only extra-pulmonary infection was considered (17% and 68%, respectively; P < 0.001). This trial demonstrates that BCG vaccination of goats can significantly reduce the TB lesion rates in high disease exposure conditions, indicating that vaccination could contribute to the control of TB in domestic goats.

Microbiological Evaluation of the Efficacy of Soapy Water to Clean Hands: A Randomized, Non-Inferiority Field Trial

PubMed Central

Amin, Nuhu; Pickering, Amy J.; Ram, Pavani K.; Unicomb, Leanne; Najnin, Nusrat; Homaira, Nusrat; Ashraf, Sania; Abedin, Jaynal; Islam, M. Sirajul; Luby, Stephen P.

2014-01-01

We conducted a randomized, non-inferiority field trial in urban Dhaka, Bangladesh among mothers to compare microbial efficacy of soapy water (30 g powdered detergent in 1.5 L water) with bar soap and water alone. Fieldworkers collected hand rinse samples before and after the following washing regimens: scrubbing with soapy water for 15 and 30 seconds; scrubbing with bar soap for 15 and 30 seconds; and scrubbing with water alone for 15 seconds. Soapy water and bar soap removed thermotolerant coliforms similarly after washing for 15 seconds (mean log10 reduction = 0.7 colony-forming units [CFU], P < 0.001 for soapy water; mean log10 reduction = 0.6 CFU, P = 0.001 for bar soap). Increasing scrubbing time to 30 seconds did not improve removal (P > 0.05). Scrubbing hands with water alone also reduced thermotolerant coliforms (mean log10 reduction = 0.3 CFU, P = 0.046) but was less efficacious than scrubbing hands with soapy water. Soapy water is an inexpensive and microbiologically effective cleansing agent to improve handwashing among households with vulnerable children. PMID:24914003

Correlates of protection for rotavirus vaccines: Possible alternative trial endpoints, opportunities, and challenges.

PubMed

Angel, Juana; Steele, A Duncan; Franco, Manuel A

2014-01-01

Rotavirus (RV) is a major vaccine-preventable killer of young children worldwide. Two RV vaccines are globally commercially available and other vaccines are in different stages of development. Due to the absence of a suitable correlate of protection (CoP), all RV vaccine efficacy trials have had clinical endpoints. These trials represent an important challenge since RV vaccines have to be introduced in many different settings, placebo-controlled studies are unethical due to the availability of licensed vaccines, and comparator assessments for new vaccines with clinical endpoints are very large, complex, and expensive to conduct. A CoP as a surrogate endpoint would allow predictions of vaccine efficacy for new RV vaccines and enable a regulatory pathway, contributing to the more rapid development of new RV vaccines. The goal of this review is to summarize experiences from RV natural infection and vaccine studies to evaluate potential CoP for use as surrogate endpoints for assessment of new RV vaccines, and to explore challenges and opportunities in the field.

Chlorfenapyr, a Potent Alternative Insecticide of Phoxim To Control Bradysia odoriphaga (Diptera: Sciaridae).

PubMed

Zhao, Yunhe; Wang, Qiuhong; Wang, Yao; Zhang, Zhengqun; Wei, Yan; Liu, Feng; Zhou, Chenggang; Mu, Wei

2017-07-26

Bradysia odoriphaga is the major pest affecting Chinese chive production, and in China, it has developed widespread resistance to organophosphorus insecticides. Chlorfenapyr is a promising pyrrole insecticide with a unique mechanism of action that does not confer cross-resistance to neurotoxic insecticides. However, the effect of chlorfenapyr on organophosphate-resistant B. odoriphaga is not well understood. The present study evaluated the potential of chlorfenapyr for the control of phoxim-resistant B. odoriphaga. The results showed that chlorfenapyr had significant insecticidal activity to B. odoriphaga in multiple developmental stages, and there were no significant differences in susceptibility between the field (phoxim-resistant) and laboratory (phoxim-susceptible) populations. The pot experiment and field trials confirmed the results of our laboratory bioassays. In the field trial, chlorfenapyr applied at 3.0, 6.0, or 12.0 kg of active ingredient (a.i.)/ha significantly decreased the number of B. odoriphaga and improved the yield compared to phoxim at 6.0 kg of a.i./ha and the control conditions. Moreover, the final residues of chlorfenapyr on plants were below the maximum residue limits (MRLs) as a result of its non-systemic activity. These results demonstrate that chlorfenapyr has potential as a potent alternative to phoxim for controlling B. odoriphaga.

Health system reform and the role of field sites based upon demographic and health surveillance.

PubMed Central

Tollman, S. M.; Zwi, A. B.

2000-01-01

Field sites for demographic and health surveillance have made well-recognized contributions to the evaluation of new or untested interventions, largely through efficacy trials involving new technologies or the delivery of selected services, e.g. vaccines, oral rehydration therapy and alternative contraceptive methods. Their role in health system reform, whether national or international, has, however, proved considerably more limited. The present article explores the characteristics and defining features of such field sites in low-income and middle-income countries and argues that many currently active sites have a largely untapped potential for contributing substantially to national and subnational health development. Since the populations covered by these sites often correspond with the boundaries of districts or subdistricts, the strategic use of information generated by demographic surveillance can inform the decentralization efforts of national and provincial health authorities. Among the areas of particular importance are the following: making population-based information available and providing an information resource; evaluating programmes and interventions; and developing applications to policy and practice. The question is posed as to whether their potential contribution to health system reform justifies arguing for adaptations to these field sites and expanded investment in them. PMID:10686747

Design and analysis considerations in the Ebola_Tx trial evaluating convalescent plasma in the treatment of Ebola virus disease in Guinea during the 2014-2015 outbreak.

PubMed

Edwards, Tansy; Semple, Malcolm G; De Weggheleire, Anja; Claeys, Yves; De Crop, Maaike; Menten, Joris; Ravinetto, Raffaella; Temmerman, Sarah; Lynen, Lutgarde; Bah, Elhadj Ibrahima; Smith, Peter G; van Griensven, Johan

2016-02-01

The Ebola virus disease outbreak in 2014-2015 led to a huge caseload with a high case fatality rate. No specific treatments were available beyond supportive care for conditions such as dehydration and shock. Evaluation of treatment with convalescent plasma from Ebola survivors was identified as a priority. We evaluated this intervention in an emergency setting, where randomization was unacceptable. The original trial design was an open-label study comparing patients receiving convalescent plasma and supportive care to patients receiving supportive care alone. The comparison group comprised patients recruited at the start of the trial before convalescent plasma became available, as well as patients presenting during the trial for whom there was insufficient blood group-compatible plasma or no staffing capacity to provide additional transfusions. However, during the trial, convalescent plasma was available to treat all new patients. The design was changed to use a comparator group comprising patients previously treated at the same Ebola treatment center prior to the start of the trial. In the analysis, it was planned to adjust for any differences in prognostic variables between intervention and comparison groups, specifically baseline polymerase chain reaction cycle threshold and age. In addition, adjustment was planned for other potential confounders, identified in the analysis, such as patient presenting symptoms and time to treatment seeking. Because plasma treatment started up to 3 days after diagnosis and we could not define a similar time-point for the comparator group, patients who died before the third day after confirmation of diagnosis were excluded from both intervention and comparison groups in a per-protocol analysis. Some patients received additional experimental treatments soon after plasma treatment, and these were excluded. We also analyzed mortality including all patients from the time of confirmed diagnosis, irrespective of whether those in the trial series actually received plasma, as an intention-to-treat analysis. Per-protocol and intention-to-treat approaches gave similar conclusions. An important caveat in the interpretation of the findings is that it is unlikely that all potential sources of confounding, such as any variation in supportive care over time, were eliminated. Protocols and electronic data capture systems have now been extensively field-tested for emergency evaluation of treatment with convalescent plasma. Ongoing studies seek to quantify the level of neutralizing antibodies in different plasma donations to determine whether this influences the response and survival of treated patients. © The Author(s) 2016.

21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

Code of Federal Regulations, 2010 CFR

2010-04-01

... clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... and evaluation of clinical trials. For drugs covered under this section, the Commissioner and other agency officials will monitor the progress of the conduct and evaluation of clinical trials and be...

Microwave bale moisture sensing: Field trial

USDA-ARS?s Scientific Manuscript database

A microwave moisture measurement technique was developed for moisture sensing of cotton bales after the bale press. The technique measures the propagation delay of a microwave signal that is transmitted through the cotton bale. This research conducted a field trial to test the sensor in a commercial...

Linkages Among Agronomic, Environmental and Weed Management Characteristics in North American Sweet Corn

USDA-ARS?s Scientific Manuscript database

Performance of weed management systems varies greatly across the landscape in both growers’ fields and in experimental trials conducted by agricultural scientists. Using agronomic, environmental, and weed management information from growers’ fields and experimental trials, we identified dominant ch...

Field Trial of the Enhanced Data Authentication System (EDAS)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Thomas, Maikael A.; Baldwin, George T.; Hymel, Ross W.

2016-05-01

The goal of the field trial of EDAS was to demonstrate the utility of secure branching of operator instrumentation for nuclear safeguards, identify any unforeseen implementation and application issues with EDAS, and confirm whether the approach is compatible with operator concerns and constraints.

Patient-reported outcomes in drug development for hematology.

PubMed

Acquadro, Catherine; Regnault, Antoine

2015-01-01

Patient-reported outcomes (PROs) are any outcome evaluated directly by the patient himself and based on the patient's perception of a disease and its treatment(s). PROs are direct outcome measures that can be used as clinical meaningful endpoints to characterize treatment benefit. They provide unique and important information about the effect of treatment from a patient's view. However, PROs will only be considered adequate if the assessment is well-defined and reliable. In 2009, the FDA has issued a guidance, which defines good measurement principles to consider for PRO measures intended to give evidence of treatment benefit in drug development. In hematologic clinical trials, when applied rigorously, they may be used to evaluate overall treatment effectiveness, treatment toxicity, and quality of patient's well-being at short-term and long-term after treatment from a patient's perspective. In situations in which multiple treatment options exist with similar survival outcome or if a new therapeutic strategy needs to be evaluated, the inclusion of PROs as an endpoint can provide additional data and help in clinical decision making. Given the diversity of the hematological field, the approach to measurement needs to be tailored for each specific situation. The importance of PROs in hematologic diseases has been highlighted in a number of international recommendations. In addition, new perspectives in the regulatory field will enhance the inclusion of PRO endpoints in clinical trials in hematology, allowing the voice of the patients with hematologic diseases to be taken into greater consideration in the development of new drugs. © 2015 by The American Society of Hematology. All rights reserved.

The EU-project United4Health: User-centred design of an information system for a Norwegian telemedicine service.

PubMed

Smaradottir, Berglind; Gerdes, Martin; Martinez, Santiago; Fensli, Rune

2016-10-01

Organizational changes of health care services in Norway brought to light a need for new clinical pathways. This study presents the design and evaluation of an information system for a new telemedicine service for chronic obstructive pulmonary disease patients after hospital discharge. A user-centred design approach was employed composed of a workshop with end-users, two user tests and a field trial. For data collection, qualitative methods such as observations, semi-structured interviews and a questionnaire were used. User workshop's outcome informed the implementation of the system initial prototype, evaluated by end-users in a usability laboratory. Several usability and functionality issues were identified and solved, such as the interface between the initial colour scheme and the triage colours. Iterative refinements were made and a second user evaluation showed that the main issues were solved. The responses to a questionnaire presented a high score of user satisfaction. In the final phase, a field trial showed satisfactory use of the system. This study showed how the target end-users groups were actively involved in identifying the needs, suggestions and preferences. These aspects were addressed in the development of an information system through a user-centred design process. The process efficiently enabled users to give feedback about design and functionality. Continuous refinement of the system was the key to full development and suitability for the telemedicine service. This research was a result of the international cooperation between partners within the project United4Health, a part of the Seventh Framework Programme for Research of the European Union. © The Author(s) 2015.

Vinpocetine for acute ischaemic stroke.

PubMed

Bereczki, D; Fekete, I

2008-01-23

Vasoactive and neuroprotective drugs such as vinpocetine are used to treat stroke in some countries. To assess the effect of vinpocetine in acute ischaemic stroke. We searched the Cochrane Stroke Group Trials Register (last searched February 2007), MEDLINE (1966 to February 2007) and Scopus (1960 to February 2007). We also searched the Internet Stroke Center Stroke Trials Registry, Google Scholar, the science-specific search engine Scirus and Wanfang Data, the leading information provider in China. We contacted researchers in the field and four pharmaceutical companies that manufacture vinpocetine. Searches were complete to February 2007. Unconfounded randomised trials of vinpocetine compared with placebo, or any other reference treatment, in people with acute ischaemic stroke. We included trials if treatment started no later than 14 days after stroke onset. Two review authors independently applied the inclusion criteria. One review author extracted the data, which was then checked by the second review author. We assessed trial quality. The primary outcome measure was death or dependency. We included two trials, involving a total of 70 participants. Data for 63 participants were reported in the two trials combined. The rate of death or dependency did not differ between the treatment and placebo groups at one and three months. The 95% confidence intervals for the outcome measures were wide and included the possibility of both significant benefit and significant harm. No adverse effects were reported. There is not enough evidence to evaluate the effect of vinpocetine on survival or dependency in patients with acute ischaemic stroke.

Critical early thrombolytic and endovascular reperfusion therapy for acute ischemic stroke victims: a call for adjunct neuroprotection.

PubMed

Lapchak, Paul A

2015-10-01

Today, there is an enormous amount of excitement in the field of stroke victim care due to the recent success of MR. CLEAN, SWIFT PRIME, ESCAPE, EXTEND-IA, and REVASCAT endovascular trials. Successful intravenous (IV) recombinant tissue plasminogen activator (rt-PA) clinical trials [i.e., National Institute of Neurological Disorders and Stroke (NINDS) rt-PA trial, Third European Cooperative Acute Stroke Study (ECASSIII), and Third International Stroke study (IST-3)] also need to be emphasized. In the recent endovascular and thrombolytic trials, there is statistically significant improvement using both the National Institutes of Health Stroke Scale (NIHSS) and the modified Rankin Score (mRS) scale, but neither approach promotes complete recovery in patients enrolled within any particular NIHSS or mRS score tier. Absolute improvement (mRS 0-2 at 90 days) with endovascular therapy is 13.5-31 %, whereas thrombolytics alone also significantly improve patient functional independence, but to a lesser degree (NINDS rt-PA trial 13 %). This article has 3 main goals: (1) first to emphasize the utility and cost-effectiveness of rt-PA to treat stroke; (2) second to review the recent endovascular trials with respect to efficacy, safety, and cost-effectiveness as a stroke treatment; and (3) to further consider and evaluate strategies to develop novel neuroprotective drugs. A thesis will be put forth so that future stroke trials and therapy development can optimally promote recovery so that stroke victims can return to "normal" life.

Strategies to improve retention in randomised trials

PubMed Central

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

2013-01-01

Background Loss to follow-up from randomised trials can introduce bias and reduce study power, affecting the generalisability, validity and reliability of results. Many strategies are used to reduce loss to follow-up and improve retention but few have been formally evaluated. Objectives To quantify the effect of strategies to improve retention on the proportion of participants retained in randomised trials and to investigate if the effect varied by trial strategy and trial setting. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PreMEDLINE, EMBASE, PsycINFO, DARE, CINAHL, Campbell Collaboration's Social, Psychological, Educational and Criminological Trials Register, and ERIC. We handsearched conference proceedings and publication reference lists for eligible retention trials. We also surveyed all UK Clinical Trials Units to identify further studies. Selection criteria We included eligible retention trials of randomised or quasi-randomised evaluations of strategies to increase retention that were embedded in 'host' randomised trials from all disease areas and healthcare settings. We excluded studies aiming to increase treatment compliance. Data collection and analysis We contacted authors to supplement or confirm data that we had extracted. For retention trials, we recorded data on the method of randomisation, type of strategy evaluated, comparator, primary outcome, planned sample size, numbers randomised and numbers retained. We used risk ratios (RR) to evaluate the effectiveness of the addition of strategies to improve retention. We assessed heterogeneity between trials using the Chi2 and I2 statistics. For main trials that hosted retention trials, we extracted data on disease area, intervention, population, healthcare setting, sequence generation and allocation concealment. Main results We identified 38 eligible retention trials. Included trials evaluated six broad types of strategies to improve retention. These were incentives, communication strategies, new questionnaire format, participant case management, behavioural and methodological interventions. For 34 of the included trials, retention was response to postal and electronic questionnaires with or without medical test kits. For four trials, retention was the number of participants remaining in the trial. Included trials were conducted across a spectrum of disease areas, countries, healthcare and community settings. Strategies that improved trial retention were addition of monetary incentives compared with no incentive for return of trial-related postal questionnaires (RR 1.18; 95% CI 1.09 to 1.28, P value < 0.0001), addition of an offer of monetary incentive compared with no offer for return of electronic questionnaires (RR 1.25; 95% CI 1.14 to 1.38, P value < 0.00001) and an offer of a GBP20 voucher compared with GBP10 for return of postal questionnaires and biomedical test kits (RR 1.12; 95% CI 1.04 to 1.22, P value < 0.005). The evidence that shorter questionnaires are better than longer questionnaires was unclear (RR 1.04; 95% CI 1.00 to 1.08, P value = 0.07) and the evidence for questionnaires relevant to the disease/condition was also unclear (RR 1.07; 95% CI 1.01 to 1.14). Although each was based on the results of a single trial, recorded delivery of questionnaires seemed to be more effective than telephone reminders (RR 2.08; 95% CI 1.11 to 3.87, P value = 0.02) and a 'package' of postal communication strategies with reminder letters appeared to be better than standard procedures (RR 1.43; 95% CI 1.22 to 1.67, P value < 0.0001). An open trial design also appeared more effective than a blind trial design for return of questionnaires in one fracture prevention trial (RR 1.37; 95% CI 1.16 to 1.63, P value = 0.0003). There was no good evidence that the addition of a non-monetary incentive, an offer of a non-monetary incentive, 'enhanced' letters, letters delivered by priority post, additional reminders, or questionnaire question order either increased or decreased trial questionnaire response/retention. There was also no evidence that a telephone survey was either more or less effective than a monetary incentive and a questionnaire. As our analyses are based on single trials, the effect on questionnaire response of using offers of charity donations, sending reminders to trial sites and when a questionnaire is sent, may need further evaluation. Case management and behavioural strategies used for trial retention may also warrant further evaluation. Authors' conclusions Most of the retention trials that we identified evaluated questionnaire response. There were few evaluations of ways to improve participants returning to trial sites for trial follow-up. Monetary incentives and offers of monetary incentives increased postal and electronic questionnaire response. Some other strategies evaluated in single trials looked promising but need further evaluation. Application of the findings of this review would depend on trial setting, population, disease area, data collection and follow-up procedures. PLAIN LANGUAGE SUMMARY Methods that might help to keep people in randomised trials Background Most trials follow people up to collect data through personal contact after they have been recruited. Some trials get data from other sources, such as routine collected data or disease registers. There are many ways to collect data from people in trials, and these include using letters, the internet, telephone calls, text messaging, face-to-face meetings or the return of medical test kits. Most trials have missing data, for example, because people are too busy to reply, are unable to attend a clinic, have moved or no longer want to participate. Sometimes data has not been recorded at study sites, or are not sent to the trial co-ordinating centre. Researchers call this 'loss to follow-up', 'drop out' or 'attrition' and it can affect the trial's results. For example, if the people with the most or least severe symptoms do not return questionnaires or attend a follow-up visit, this will bias the findings of the trial. Many methods are used by researchers to keep people in trials. These encourage people to send back data by questionnaire, return to a clinic or hospital for trial-related tests, or be seen by a health or community care worker. Study characteristics This review identified methods that encouraged people to stay in trials. We searched scientific databases for randomised studies (where people are allocated to one of two or more possible treatments in a random manner) or quasi-randomised studies (where allocation is not really random, e.g. based on date of birth, order in which they attended clinic) that compared methods of increasing retention in trials. We included trials of participants from any age, gender, ethnic, cultural, language and geographic groups. Key results The methods that appeared to work were offering or giving a small amount of money for return of a completed questionnaire and enclosing a small amount of money with a questionnaire with the promise of a further small amount of money for return of a filled in questionnaire. The effect of other ways to keep people in trials is still not clear and more research is needed to see if these really do work. Such methods are shorter questionnaires, sending questionnaires by recorded delivery, using a trial design where people know which treatment they will receive, sending specially designed letters with a reply self addressed stamped envelope followed by a number of reminders, offering a donation to charity or entry into a prize draw, sending a reminder to the study site about participants to follow-up, sending questionnaires close to the time the patient was last followed-up, managing peoples' follow-up, conducting follow-up by telephone and changing the order of questionnaire questions. Quality of evidence The methods that we identified were tested in trials run in many different disease areas and settings and, in some cases, were tested in only one trial. Therefore, more studies are needed to help decide whether our findings could be used in other research fields. PMID:24297482

Impact of the 5As Team study on clinical practice in primary care obesity management: a qualitative study

PubMed Central

Asselin, Jodie; Salami, Eniola; Osunlana, Adedayo M.; Ogunleye, Ayodele A.; Cave, Andrew; Johnson, Jeffrey A.; Sharma, Arya M.; Campbell-Scherer, Denise L.

2017-01-01

Background: The 5As [Ask, Assess, Advise, Agree, Assist] of Obesity Management Team study was a randomized controlled trial of an intervention that was implemented and evaluated to help primary care providers improve clinical practice for obesity management. This paper presents health care provider perspectives of the impacts of the intervention on individual provider and team practices. Methods: This study reports a thematic network analysis of qualitative data collected during the 5As Team study, which involved 24 chronic disease teams affiliated with family practices in a Primary Care Network in Alberta. Qualitative data from 28 primary care providers (registered nurses/nurse practitioners [n = 14], dietitians [n = 7] and mental health workers [n = 7]) in the intervention arm were collected through semistructured interviews, field notes, practice facilitator diaries and 2 evaluation workshop questionnaires. Results: Providers internalized 5As Team intervention concepts, deepening self-evaluation and changing clinical reasoning around obesity. Providers perceived that this internalization changed the provider-patient relationship positively. The intervention changed relations between providers, increasing interdisciplinary understanding, collaboration and discovery of areas for improvement. This personal and interpersonal evolution effected change to the entire Primary Care Network. Interpretation: The 5As Team intervention had multiple impacts on providers and teams to improve obesity management in primary care. Improved provider confidence and capability is a precondition of developing effective patient interventions. Trial registration: ClinicalTrials.gov, no.: NCT01967797. PMID:28450428

OARSI Clinical Trials Recommendations: Design and conduct of clinical trials for primary prevention of osteoarthritis by joint injury prevention in sport and recreation.

PubMed

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

2015-05-01

The risk of post-traumatic osteoarthritis (PTOA) substantially increases following joint injury. Research efforts should focus on investigating the efficacy of preventative strategies in high quality randomized controlled trials (RCT). The objective of these OARSI RCT recommendations is to inform the design, conduct and analytical approaches to RCTs evaluating the preventative effect of joint injury prevention strategies. Recommendations regarding the design, conduct, and reporting of RCTs evaluating injury prevention interventions were established based on the consensus of nine researchers internationally with expertise in epidemiology, injury prevention and/or osteoarthritis (OA). Input and resultant consensus was established through teleconference, face to face and email correspondence over a 1 year period. Recommendations for injury prevention RCTs include context specific considerations regarding the research question, research design, study participants, randomization, baseline characteristics, intervention, outcome measurement, analysis, implementation, cost evaluation, reporting and future considerations including the impact on development of PTOA. Methodological recommendations for injury prevention RCTs are critical to informing evidence-based practice and policy decisions in health care, public health and the community. Recommendations regarding the interpretation and conduct of injury prevention RCTs will inform the highest level of evidence in the field. These recommendations will facilitate between study comparisons to inform best practice in injury prevention that will have the greatest public health impact. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Ghosts in the Machine II: Neural Correlates of Memory Interference from the Previous Trial.

PubMed

Papadimitriou, Charalampos; White, Robert L; Snyder, Lawrence H

2017-04-01

Previous memoranda interfere with working memory. For example, spatial memories are biased toward locations memorized on the previous trial. We predicted, based on attractor network models of memory, that activity in the frontal eye fields (FEFs) encoding a previous target location can persist into the subsequent trial and that this ghost will then bias the readout of the current target. Contrary to this prediction, we find that FEF memory representations appear biased away from (not toward) the previous target location. The behavioral and neural data can be reconciled by a model in which receptive fields of memory neurons converge toward remembered locations, much as receptive fields converge toward attended locations. Convergence increases the resources available to encode the relevant memoranda and decreases overall error in the network, but the residual convergence from the previous trial can give rise to an attractive behavioral bias on the next trial. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Auxiliary-field-based trial wave functions in quantum Monte Carlo calculations

DOE Office of Scientific and Technical Information (OSTI.GOV)

Chang, Chia -Chen; Rubenstein, Brenda M.; Morales, Miguel A.

2016-12-19

Quantum Monte Carlo (QMC) algorithms have long relied on Jastrow factors to incorporate dynamic correlation into trial wave functions. While Jastrow-type wave functions have been widely employed in real-space algorithms, they have seen limited use in second-quantized QMC methods, particularly in projection methods that involve a stochastic evolution of the wave function in imaginary time. Here we propose a scheme for generating Jastrow-type correlated trial wave functions for auxiliary-field QMC methods. The method is based on decoupling the two-body Jastrow into one-body projectors coupled to auxiliary fields, which then operate on a single determinant to produce a multideterminant trial wavemore » function. We demonstrate that intelligent sampling of the most significant determinants in this expansion can produce compact trial wave functions that reduce errors in the calculated energies. Lastly, our technique may be readily generalized to accommodate a wide range of two-body Jastrow factors and applied to a variety of model and chemical systems.« less

Field tests of an acephate baiting system designed for eradicating undesirable honey bees (Hymenoptera: Apidae).

PubMed

Danka, R G; Williams, J L; Sugden, E A; Rivera, R

1992-08-01

Field evaluations were made of a baiting system designed for use by regulatory agencies in suppressing populations of undesirable feral honey bees, Apis mellifera L. (e.g., bees posing hazards [especially Africanized bees] and colonies infested with parasitic mites). Bees from feral or simulated feral (hived) colonies were lured with honey and Nasonov pheromone components to feeders dispensing sucrose-honey syrup. After 1-3 wk of passive training to feeders, colonies were treated during active foraging by replacing untreated syrup with syrup containing 500 ppm (mg/liter) acephate (Orthene 75 S). In four trials using hived colonies on Grant Terre Island, LA., 21 of 29 colonies foraged actively enough at baits to be treated, and 20 of the 22 treated were destroyed. In the lower Rio Grande Valley of Texas (two trials at each of two trials), treatments killed 11 of 16 colonies (6 of 10 hived; 50 of 6 feral). Overall results showed that all 11 colonies that collected greater than 25 mg acephate died, whereas 3 of 10 colonies receiving less than 25 mg survived. Delivering adequate doses required a minimum of approximately 100 bees per target colony simultaneously collecting treated syrup. The system destroyed target colonies located up to nearly 700 m away from baits. Major factors limiting efficacy were conditions inhibiting foraging at baits (e.g., competing natural nectar sources and temperatures and winds that restricted bee flight).

Assessment of variable fluorescence fluorometry as an approach for rapidly detecting living photoautotrophs in ballast water

NASA Astrophysics Data System (ADS)

First, Matthew R.; Robbins-Wamsley, Stephanie H.; Riley, Scott C.; Drake, Lisa A.

2018-03-01

Variable fluorescence fluorometry, an analytical approach that estimates the fluorescence yield of chlorophyll a (F0, a proximal measure of algal concentration) and photochemical yield (FV/FM, an indicator of the physiological status of algae) was evaluated as a means to rapidly assess photoautotrophs. Specifically, it was used to gauge the efficacy of ballast water treatment designed to reduce the transport and delivery of potentially invasive organisms. A phytoflagellate, Tetraselmis spp. (10-12 μm) and mixed communities of ambient protists were examined in both laboratory experiments and large-scale field trials simulating 5-d hold times in mock ballast tanks. In laboratory incubations, ambient organisms held in the dark exhibited declining F0 and FV/FM measurements relative to organisms held under lighted conditions. In field experiments, increases and decreases in F0 and FV/FM over the tank hold time corresponded to those of microscope counts of organisms in two of three trials. In the third trial, concentrations of organisms ≥ 10 and < 50 μm (presumably heterotrophic protists) increased while F0 and FV/FM decreased. Rapid and sensitive, variable fluorescence fluorometry is appropriate for detecting changes in organism concentrations and physiological status in samples dominated by microalgae. Changes in the heterotrophic community, which may become more prevalent in light-limited ballast tanks, would not be detected via variable fluorescence fluorometry, however.

Creating and field-testing diagnostic criteria for partner and child maltreatment.

PubMed

Heyman, Richard E; Smith Slep, Amy M

2006-09-01

An integrated set of diagnostic criteria for partner abuse and child abuse and neglect were developed and tested in 4 studies conducted with a branch of America's largest family maltreatment protection agency (i.e., the U.S. military's Family Advocacy Program). Maltreatment criteria then in force were found to have adequate levels of content validity, but experts' and users' feedback indicated ambiguities and poorly specified criteria that undermined reliable application. Criteria incorporating elements of the best existing civilian and military operationalizations were developed and evaluated in two field trials. The final definitions were found to support very high levels of agreement (92%) between base adjudicating committees and master reviewers. Copyright (c) 2006 APA, all rights reserved.

Salt-Rich Selenium for Prevention and Control Children with Kashin-Beck Disease: a Meta-analysis of Community-Based Trial.

PubMed

Yu, Fang-fang; Han, Jing; Wang, Xi; Fang, Hua; Liu, Huan; Guo, Xiong

2016-03-01

Kashin-Beck disease (KBD) in western China is not well controlled. The objective of this study is to evaluate prevention and control children with KBD through a meta-analysis of a community-based trial. Web of knowledge, PubMed, Elsevier, the Chinese National Knowledge Infrastructure (CNKI), VIP and Wanfang data had been electronically searched up to February 2015. Search terms included the trial terms "Salt rich selenium" and "Kashin-Beck disease." Eligible studies were prospective trials of salt-rich selenium in endemic villages. Data extraction was performed by two authors using predefined data fields that also included quality evaluation. Of 292 potentially relevant articles initially screened, reporting 11 community-based trials with a total enrollment of 2652 participants were included, from five provinces in China. The pooled odds ratios (OR) and 95 % confidence intervals (CI) of primary prevention in healthy children were 0.16 and 0.08∼0.33, respectively. The OR and 95 % CI of clinical improvement in KBD children were 6.57 and 3.33∼12.93, respectively. The OR of repairing rate of metaphysis lesions was 5.53 (95 % CI 2.92∼10.47) based on X-ray film, which was statistically significantly different in favor of salt-rich selenium. The combined standard mean difference (SMD) of selenium content in hair was 2.54 (95 % CI 1.21∼3.87) which was significantly higher in selenium group. Current evidence showed that supplement salt-rich selenium was effective in reducing new incidence in healthy children and clinical improvement including repairing metaphysis lesions instead of repairing distal end of phalanx lesions in KBD children.

Tuberculosis vaccines in clinical trials

PubMed Central

Rowland, Rosalind; McShane, Helen

2011-01-01

Effective prophylactic and/or therapeutic vaccination is a key strategy for controlling the global TB epidemic. The partial effectiveness of the existing TB vaccine, bacille Calmette–Guérin (BCG), suggests effective vaccination is possible and highlights the need for an improved vaccination strategy. Clinical trials are evaluating both modifications to the existing BCG immunization methods and also novel TB vaccines, designed to replace or boost BCG. Candidate vaccines in clinical development include live mycobacterial vaccines designed to replace BCG, subunit vaccines designed to boost BCG and therapeutic vaccines designed as an adjunct to chemotherapy. There is a great need for validated animal models, identification of immunological biomarkers of protection and field sites with the capacity for large-scale efficacy testing in order to develop and license a novel TB vaccine or regimen. PMID:21604985

Field efficacy of eprinomectin against the sucking louse Haematopinus asini on naturally infested donkeys.

PubMed

Veneziano, Vincenzo; Galietti, Alfredo; Mariani, Ugo; Di Loria, Antonio; Piantedosi, Diego; Neola, Benedetto; Guccione, Jacopo; Gokbulut, Cengiz

2013-08-01

A trial was conducted to assess the efficacy of eprinomectin (EPR) against the sucking louse Haematopinus asini on naturally infested donkeys. Parasitological investigations were performed on fifteen animals. On day 0, donkeys received EPR pour-on at the manufacturer's recommended cattle dose. Louse counts were performed on days -1, 7, 14, 21, 28, 35, 42, 49 and 56 at seven predilection sites on the skin of each donkey. EPR was completely effective (100%) from day 7, until the end of the study. Clinically no adverse reactions were observed in any of donkeys treated. EPR was considered to be 100% effective against H. asini. This is the first trial to evaluate the efficacy of EPR against a natural louse infestation in donkeys. Copyright © 2013 Elsevier Ltd. All rights reserved.

Anticipation of the Impact of Human Papillomavirus on Clinical Decision Making for the Head and Neck Cancer Patient.

PubMed

Gillison, Maura L; Restighini, Carlo

2015-12-01

Human papillomavirus (HPV) is the cause of a distinct subset of oropharyngeal cancer rising in incidence in the United States and other developed countries. This increased incidence, combined with the strong effect of tumor HPV status on survival, has had a profound effect on the head and neck cancer discipline. The multidisciplinary field of head and neck cancer is in the midst of re-evaluating evidence-based algorithms for clinical decision making, developed from clinical trials conducted in an era when HPV-negative cancer predominated. This article reviews relationships between tumor HPV status and gender, cancer incidence trends, overall survival, treatment response, racial disparities, tumor staging, risk stratification, survival post disease progression, and clinical trial design. Copyright © 2015 Elsevier Inc. All rights reserved.

Safe household water treatment and storage using ceramic drip filters: a randomised controlled trial in Bolivia.

PubMed

Clasen, T; Brown, J; Suntura, O; Collin, S

2004-01-01

A randomised controlled field trial was conducted to evaluate the effectiveness of ceramic drip filters to improve the microbiological quality of drinking water in a low-income community in rural Bolivia. In four rounds of water sampling over five months, 100% of the samples were free of thermotolerant (faecal) coliforms (TTC) compared to an arithmetic mean TTC count of 1517, 406, 167 and 245 among control households which continued to use their customary sources of drinking water. The filter systems produced water that consistently met WHO drinking-water standards despite levels of turbidity that presented a challenge to other low-cost POU treatment methods. The filter systems also demonstrated an ability to maintain the high quality of the treated water against subsequent re-contamination in the home.

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 by greenhouse and lab trials.

7 CFR 1755.3 - Field trials.

Code of Federal Regulations, 2010 CFR

2010-01-01

... system electronics; (vi) Fiber optic cable system electronics; (vii) Multiplex equipment; (viii) Mobile... Telephone Systems of RUS Borrowers,” RUS Bulletin 344-2. When new items of materials or equipment are... that the field trial is carried out and that the required information on the product's performance is...

Entrepreneurship education: A strength-based approach to substance use and suicide prevention for American Indian adolescents.

PubMed

Tingey, Lauren; Larzelere-Hinton, Francene; Goklish, Novalene; Ingalls, Allison; Craft, Todd; Sprengeler, Feather; McGuire, Courtney; Barlow, Allison

2016-01-01

American Indian (AI) adolescents suffer the largest disparities in substance use and suicide. Predominating prevention models focus primarily on risk and utilize deficit-based approaches. The fields of substance use and suicide prevention research urge for positive youth development frameworks that are strength based and target change at individual and community levels. Entrepreneurship education is an innovative approach that reflects the gap in available programs. This paper describes the development and evaluation of a youth entrepreneurship education program in partnership with one AI community. We detail the curriculum, process evaluation results, and the randomized controlled trial evaluating its efficacy for increasing protective factors. Lessons learned may be applicable to other AI communities.

Randomised field trial to evaluate serological response after foot-and-mouth disease vaccination in Turkey.

PubMed

Knight-Jones, T J D; Bulut, A N; Gubbins, S; Stärk, K D C; Pfeiffer, D U; Sumption, K J; Paton, D J

2015-02-04

Despite years of biannual mass vaccination of cattle, foot-and-mouth disease (FMD) remains uncontrolled in Anatolian Turkey. To evaluate protection after mass vaccination we measured post-vaccination antibodies in a cohort of cattle (serotypes O, A and Asia-1). To obtain results reflecting typical field protection, participants were randomly sampled from across Central and Western Turkey after routine vaccination. Giving two-doses one month apart is recommended when cattle are first vaccinated against FMD. However, due to cost and logistics, this is not routinely performed in Turkey, and elsewhere. Nested within the cohort, we conducted a randomised trial comparing post-vaccination antibodies after a single-dose versus a two-dose primary vaccination course. Four to five months after vaccination, only a third of single-vaccinated cattle had antibody levels above a threshold associated with protection. A third never reached this threshold, even at peak response one month after vaccination. It was not until animals had received three vaccine doses in their lifetime, vaccinating every six months, that most (64% to 86% depending on serotype) maintained antibody levels above this threshold. By this time cattle would be >20 months old with almost half the population below this age. Consequently, many vaccinated animals will be unprotected for much of the year. Compared to a single-dose, a primary vaccination course of two-doses greatly improved the level and duration of immunity. We concluded that the FMD vaccination programme in Anatolian Turkey did not produce the high levels of immunity required. Higher potency vaccines are now used throughout Turkey, with a two-dose primary course in certain areas. Monitoring post-vaccination serology is an important component of evaluation for FMD vaccination programmes. However, consideration must be given to which antigens are present in the test, the vaccine and the field virus. Differences between these antigens affect the relationship between antibody titre and protection. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

Use of ClinicalTrials.gov to estimate condition-specific nocebo effects and other factors affecting outcomes of analgesic trials.

PubMed

Cepeda, M Soledad; Lobanov, Victor; Berlin, Jesse A

2013-04-01

ClinicalTrials.gov is a registry and results database of federally and privately supported clinical trials conducted worldwide. We sought to answer: what are the characteristics of pain trials; how frequently are these trials stopped and why; what is the magnitude of attrition due to lack of efficacy or adverse events; and whether the withdrawal rates depend on pain syndrome. To facilitate this and subsequent studies, we have developed a system called Sherlock that automatically downloads data from ClinicalTrials.gov into a relational database. We included pain interventional trials. To evaluate attrition, we restricted consideration to prospective randomized, parallel, double-blind, placebo-controlled trials. Of the 82,867 trials, 6% reported results and 5.6% terminated before the planned number of subjects was accrued. Of these early terminations, 38% were due to enrollment difficulties. In the placebo arms, 3.8% of participants withdrew due to lack of efficacy and 4.9% due to adverse events, with proportions differing among pain conditions. Compared with migraine trials, in fibromyalgia trials 5.1% more participants withdrew due to lack of efficacy (95% confidence interval [CI], 2.5-7.8%), and 6.4% more withdrew due to adverse events (95% CI, 4.3-8.6%). Nonsteroidal anti-inflammatory drugs were the treatment class with the lowest adverse events withdrawals. Recruitment challenges account for the largest proportion of noncompleted trials. Attrition rates differ across pain conditions. Migraine studies had the lowest withdrawal rate. Tools like Sherlock facilitate conducting research in the ClinicalTrials.gov registry. ClinicalTrials.gov registry enables researchers to get a snapshot of a specific field and observe changes over time in trial design, including numbers of subjects accrued, and it can inform clinical trial design. We learned that recruitment challenges account for the largest proportion of noncompleted trials, attrition rates differed across pain conditions, and migraine studies had the lowest withdrawal rate. Copyright © 2013 American Pain Society. Published by Elsevier Inc. All rights reserved.

Estimating economic thresholds for site-specific weed control using manual weed counts and sensor technology: an example based on three winter wheat trials.

PubMed

Keller, Martina; Gutjahr, Christoph; Möhring, Jens; Weis, Martin; Sökefeld, Markus; Gerhards, Roland

2014-02-01

Precision experimental design uses the natural heterogeneity of agricultural fields and combines sensor technology with linear mixed models to estimate the effect of weeds, soil properties and herbicide on yield. These estimates can be used to derive economic thresholds. Three field trials are presented using the precision experimental design in winter wheat. Weed densities were determined by manual sampling and bi-spectral cameras, yield and soil properties were mapped. Galium aparine, other broad-leaved weeds and Alopecurus myosuroides reduced yield by 17.5, 1.2 and 12.4 kg ha(-1) plant(-1)  m(2) in one trial. The determined thresholds for site-specific weed control with independently applied herbicides were 4, 48 and 12 plants m(-2), respectively. Spring drought reduced yield effects of weeds considerably in one trial, since water became yield limiting. A negative herbicide effect on the crop was negligible, except in one trial, in which the herbicide mixture tended to reduce yield by 0.6 t ha(-1). Bi-spectral cameras for weed counting were of limited use and still need improvement. Nevertheless, large weed patches were correctly identified. The current paper presents a new approach to conducting field trials and deriving decision rules for weed control in farmers' fields. © 2013 Society of Chemical Industry.

Study protocol of a mixed-methods evaluation of a cluster randomized trial to improve the safety of NSAID and antiplatelet prescribing: data-driven quality improvement in primary care.

PubMed

Grant, Aileen; Dreischulte, Tobias; Treweek, Shaun; Guthrie, Bruce

2012-08-28

Trials of complex interventions are criticized for being 'black box', so the UK Medical Research Council recommends carrying out a process evaluation to explain the trial findings. We believe it is good practice to pre-specify and publish process evaluation protocols to set standards and minimize bias. Unlike protocols for trials, little guidance or standards exist for the reporting of process evaluations. This paper presents the mixed-method process evaluation protocol of a cluster randomized trial, drawing on a framework designed by the authors. This mixed-method evaluation is based on four research questions and maps data collection to a logic model of how the data-driven quality improvement in primary care (DQIP) intervention is expected to work. Data collection will be predominately by qualitative case studies in eight to ten of the trial practices, focus groups with patients affected by the intervention and quantitative analysis of routine practice data, trial outcome and questionnaire data and data from the DQIP intervention. We believe that pre-specifying the intentions of a process evaluation can help to minimize bias arising from potentially misleading post-hoc analysis. We recognize it is also important to retain flexibility to examine the unexpected and the unintended. From that perspective, a mixed-methods evaluation allows the combination of exploratory and flexible qualitative work, and more pre-specified quantitative analysis, with each method contributing to the design, implementation and interpretation of the other.As well as strengthening the study the authors hope to stimulate discussion among their academic colleagues about publishing protocols for evaluations of randomized trials of complex interventions. DATA-DRIVEN QUALITY IMPROVEMENT IN PRIMARY CARE TRIAL REGISTRATION: ClinicalTrials.gov: NCT01425502.

Laboratory and field evaluation of the impact of exercise on the performance of regular and polymer-based deet repellents.

PubMed

Schofield, Steven; Tepper, Martin; Gadawski, Randy

2007-11-01

Studies were done in Manitoba, Canada, to evaluate the impact of exercise on repellent performance against mosquitoes. Two products containing the active ingredient N,N-diethyl-3-methylbenzamide (deet) were tested; one product was a polymer-based cream (3M Ultrathon Insect Repellent) and the other product was an alcohol-based pump spray formulation (Muskol Insect Repellent). Assessments were done in the laboratory using Aedes aegypti (L.) and in the field with naturally occurring populations of mosquitoes. Repellent was applied to the forearms (laboratory) or a lower leg (field) of test subjects at 1.5 g of test product per 600 cm2 surface area (0.75 or 0.83 mg deet/cm2). For a given test day, subjects exercised or did not. Exposure to mosquito attack was for 1 min at 30-min intervals in laboratory procedures, and it was continuous in field tests. Performance was measured as complete protection time (CPT). Moderate levels of physical activity resulted in a >40% decline in mean CPT, from 468 to 267 min in the laboratory experiments and from 359 to 203 min in field tests. Repellent product did not affect the magnitude of the decline. Mean biting pressure during field trials was 21.3 bites per min, and mosquito collections were made up primarily of Ochlerotatus sticticus (Meigen) and Aedes vexans (Meigen).

Three-day Field Treatment with Ingenol Disoxate (LEO 43204) for Actinic Keratosis

PubMed Central

Tyring, Stephen; Nahm, Walter K.; Østerdal, Marie Louise; Petersen, Astrid H.; Berman, Brian

2017-01-01

OBJECTIVE: The purpose of this study was to evaluate the safety and efficacy of ingenol disoxate gel using a once-daily, three-day field treatment regimen in patients with actinic keratosis. DESIGN: This was a Phase II, multicenter, open-label trial (clinicaltrials.gov: NCT02305888). SETTING: The study was conducted in 20 trial sites in the United States. PARTICIPANTS: Participants included patients with 5 to 20 clinically typical actinic keratosis lesions on the full face/chest (250cm2), scalp (25–250cm2), or the trunk/extremities (250cm2). MEASUREMENTS: We measured incidence of dose-limiting events based on local skin responses. Percentage reduction in actinic keratosis lesion count from baseline, complete clearance, and partial clearance (≥75%) of actinic keratosis lesions were assessed at Week 8. RESULTS: Nine of 63 (14.3%) patients in the face/chest group reported dose-limiting events; zero of 63 patients in the scalp group reported dose-limiting events; and 11 of 62 (17.7%) patients in the trunk/extremities group reported dose-limiting events. Mean composite local skin response scores peaked at Day 4, then rapidly declined, reaching or approaching baseline levels by Week 4. Less than five percent of patients reported severe adverse events; the most common treatment-related adverse events were application site pain and pruritus. The reduction in actinic keratosis lesion count was 78.9, 76.3, and 69.1 percent for the face/chest, scalp, and trunk/extremities groups, respectively. Complete clearance was achieved in 36.5, 39.7, and 22.6 percent of patients in the face/chest, scalp, and trunk/extremities groups, respectively. Partial clearance was achieved in 71.4, 65.1, and 50.0 percent of patients in the face/chest, scalp, and trunk/extremities groups, respectively. CONCLUSION: Ingenol disoxate demonstrated adverse events and local skin reaction profiles similar to results seen in trials evaluating shorter two-day regimens and was effective in patients with actinic keratosis. These data support the use of ingenol disoxate gel for actinic keratosis field treatment. PMID:29399263

Summer School Effects in a Randomized Field Trial

ERIC Educational Resources Information Center

Zvoch, Keith; Stevens, Joseph J.

2013-01-01

This field-based randomized trial examined the effect of assignment to and participation in summer school for two moderately at-risk samples of struggling readers. Application of multiple regression models to difference scores capturing the change in summer reading fluency revealed that kindergarten students randomly assigned to summer school…

Effect of a patient training video on visual field test reliability

PubMed Central

Sherafat, H; Spry, P G D; Waldock, A; Sparrow, J M; Diamond, J P

2003-01-01

Aims: To evaluate the effect of a visual field test educational video on the reliability of the first automated visual field test of new patients. Methods: A prospective, randomised, controlled trial of an educational video on visual field test reliability of patients referred to the hospital eye service for suspected glaucoma was undertaken. Patients were randomised to either watch an educational video or a control group with no video. The video group was shown a 4.5 minute audiovisual presentation to familiarise them with the various aspects of visual field examination with particular emphasis on sources of unreliability. Reliability was determined using standard criteria of fixation loss rate less than 20%, false positive responses less than 33%, and false negative responses less than 33%. Results: 244 patients were recruited; 112 in the video group and 132 in the control group with no significant between group difference in age, sex, and density of field defects. A significant improvement in reliability (p=0.015) was observed in the group exposed to the video with 85 (75.9%) patients having reliable results compared to 81 (61.4%) in the control group. The difference was not significant for the right (first tested) eye with 93 (83.0%) of the visual fields reliable in the video group compared to 106 (80.0%) in the control group (p = 0.583), but was significant for the left (second tested) eye with 97 (86.6 %) of the video group reliable versus 97 (73.5%) of the control group (p = 0.011). Conclusions: The use of a brief, audiovisual patient information guide on taking the visual field test produced an improvement in patient reliability for individuals tested for the first time. In this trial the use of the video had most of its impact by reducing the number of unreliable fields from the second tested eye. PMID:12543740

Effect of a patient training video on visual field test reliability.

PubMed

Sherafat, H; Spry, P G D; Waldock, A; Sparrow, J M; Diamond, J P

2003-02-01

To evaluate the effect of a visual field test educational video on the reliability of the first automated visual field test of new patients. A prospective, randomised, controlled trial of an educational video on visual field test reliability of patients referred to the hospital eye service for suspected glaucoma was undertaken. Patients were randomised to either watch an educational video or a control group with no video. The video group was shown a 4.5 minute audiovisual presentation to familiarize them with the various aspects of visual field examination with particular emphasis on sources of unreliability. Reliability was determined using standard criteria of fixation loss rate less than 20%, false positive responses less than 33%, and false negative responses less than 33%. 244 patients were recruited; 112 in the video group and 132 in the control group with no significant between group difference in age, sex, and density of field defects. A significant improvement in reliability (p=0.015) was observed in the group exposed to the video with 85 (75.9%) patients having reliable results compared to 81 (61.4%) in the control group. The difference was not significant for the right (first tested) eye with 93 (83.0%) of the visual fields reliable in the video group compared to 106 (80.0%) in the control group (p = 0.583), but was significant for the left (second tested) eye with 97 (86.6 %) of the video group reliable versus 97 (73.5%) of the control group (p = 0.011). The use of a brief, audiovisual patient information guide on taking the visual field test produced an improvement in patient reliability for individuals tested for the first time. In this trial the use of the video had most of its impact by reducing the number of unreliable fields from the second tested eye.

The experience of adolescents participating in a randomised clinical trial in the field of mental health: a qualitative study.

PubMed

Midgley, Nick; Isaacs, Danny; Weitkamp, Katharina; Target, Mary

2016-07-28

This descriptive study aimed to investigate adolescents' motivations for participating in a randomised controlled trial (RCT), to explore the understanding that the young people had regarding a number of aspects of the trial design, to examine whether or not they found participation in the trial to be acceptable and what affected this, and to identify whether and how the young people felt that their participation in the RCT impacted on their experience of therapy and on therapeutic change. Seventy-six adolescents who were taking part in a large-scale RCT to evaluate the clinical and cost effectiveness of psychological therapies for depression were interviewed at two time-points after completing therapy. The semi-structured interviews, which included a focus on the young people's experience of the research study, were analysed using framework analysis. The vast majority of adolescents found it acceptable to participate in the clinical trial, and many agreed to participate for reasons of 'conditional altruism'. However consent was often given without great understanding of the key elements of the trial, including the difference between treatment arms and the randomisation process. Although the adolescents were largely positive about their experiences from taking part, the study raises questions about whether clinical outcomes may be influenced by participation in the research elements of the trial. Although adolescents are under-represented in clinical trials, those who do participate are generally positive about the experience; however, careful thought needs to be given to key elements of the trial design and the potential impact of the research participation on clinical outcomes. ISRCTN registry, ISRCTN83033550 . Registered on 15 October 2009.

Automated clinical trial eligibility prescreening: increasing the efficiency of patient identification for clinical trials in the emergency department

PubMed Central

Ni, Yizhao; Kennebeck, Stephanie; Dexheimer, Judith W; McAneney, Constance M; Tang, Huaxiu; Lingren, Todd; Li, Qi; Zhai, Haijun; Solti, Imre

2015-01-01

Objectives (1) To develop an automated eligibility screening (ES) approach for clinical trials in an urban tertiary care pediatric emergency department (ED); (2) to assess the effectiveness of natural language processing (NLP), information extraction (IE), and machine learning (ML) techniques on real-world clinical data and trials. Data and methods We collected eligibility criteria for 13 randomly selected, disease-specific clinical trials actively enrolling patients between January 1, 2010 and August 31, 2012. In parallel, we retrospectively selected data fields including demographics, laboratory data, and clinical notes from the electronic health record (EHR) to represent profiles of all 202795 patients visiting the ED during the same period. Leveraging NLP, IE, and ML technologies, the automated ES algorithms identified patients whose profiles matched the trial criteria to reduce the pool of candidates for staff screening. The performance was validated on both a physician-generated gold standard of trial–patient matches and a reference standard of historical trial–patient enrollment decisions, where workload, mean average precision (MAP), and recall were assessed. Results Compared with the case without automation, the workload with automated ES was reduced by 92% on the gold standard set, with a MAP of 62.9%. The automated ES achieved a 450% increase in trial screening efficiency. The findings on the gold standard set were confirmed by large-scale evaluation on the reference set of trial–patient matches. Discussion and conclusion By exploiting the text of trial criteria and the content of EHRs, we demonstrated that NLP-, IE-, and ML-based automated ES could successfully identify patients for clinical trials. PMID:25030032

Development of an attract-and-infect system to control Rhynchophorus ferrugineus with the entomopathogenic fungus Beauveria bassiana.

PubMed

Dembilio, Óscar; Moya, Pilar; Vacas, Sandra; Ortega-García, Lola; Quesada-Moraga, Enrique; Jaques, Josep A; Navarro-Llopis, Vicente

2018-02-09

A new Beauveria bassiana-based attract and infect device (AID) to control Rhynchophorus ferrugineus Olivier (Coleoptera: Curculionidae) was developed. The virulence and persistence of the fungal formulation used in the AID were evaluated in the laboratory. Semi-field and field trials were carried out to validate the results and establish the potential of this device as a control tool. In laboratory conditions, a 50% lethal time (LT 50 ) of 4.33 days was obtained when adults (7-10 days old) were exposed to the inoculation tunnel (IT) containing 1 × 10 10 conidia g -1 in an oil-based fungal formulation. This formulation maintained conidium viability at 50% for up to 2 months. Moreover, when adults were exposed to 2.5-month field-aged ITs, mortality still reached 50% 40 days after exposure. In addition, no differences were observed between ITs aged in early spring and those aged in summer, suggesting that the fungal formulation is not strongly affected by environmental factors in Mediterranean basin conditions. Semi-field assays showed that the device allowed an easy transit of weevils through the IT, which were effectively attracted and infected. Using the AIDs in 4-ha plot field trials, a reduction of >50% in the percentage of infested sentinel palms was obtained. Based on the results obtained in terms of the efficacy and persistence of this new AID in the field and its potential in reducing R. ferrugineus populations and palm infestation, this device could become a key tool for the management of R. ferrugineus. © 2018 Society of Chemical Industry. © 2018 Society of Chemical Industry.

Potential beneficial effects of sacubitril-valsartan in renal disease: a new field for a new drug.

PubMed

Gervasini, Guillermo; Robles, Nicolas Roberto

2017-05-01

Patients with renal dysfunction are at a higher risk of cardiovascular disease (CVD), which often shares manifestations with heart failure (HF). Last year, the FDA approved the use of sacubitril-valsartan in patients with HF. This dual-acting agent enhances the functions of natriuretic peptides and inhibits the renin-angiotensin system. Areas covered: This review summarizes the existing preclinical and clinical studies carried out with sacubitril-valsartan (and other drugs with similar pharmacological mechanisms) in HF and hypertensive patients. We put the focus on the renal data provided by these studies. Data were obtained from English peer-reviewed articles on PubMed and clinical trials registered in ClinicalTrials.gov. Expert opinion: Overall, sacubitril-valsartan might be a promising therapeutic approach in patients with renal dysfunction. Renal conditions with marked CV risk, such as arterionephrosclerosis, could constitute a particular setting where to evaluate the impact of the drug. Nevertheless, large, randomized trials are needed to confirm the beneficial effects and safety profile of the drug in renal patients, as well as to elucidate some concerns observed in HF trials, such as the slight increase in proteinuria.

Companion diagnostics and molecular imaging-enhanced approaches for oncology clinical trials.

PubMed

Van Heertum, Ronald L; Scarimbolo, Robert; Ford, Robert; Berdougo, Eli; O'Neal, Michael

2015-01-01

In the era of personalized medicine, diagnostic approaches are helping pharmaceutical and biotechnology sponsors streamline the clinical trial process. Molecular assays and diagnostic imaging are routinely being used to stratify patients for treatment, monitor disease, and provide reliable early clinical phase assessments. The importance of diagnostic approaches in drug development is highlighted by the rapidly expanding global cancer diagnostics market and the emergent attention of regulatory agencies worldwide, who are beginning to offer more structured platforms and guidance for this area. In this paper, we highlight the key benefits of using companion diagnostics and diagnostic imaging with a focus on oncology clinical trials. Nuclear imaging using widely available radiopharmaceuticals in conjunction with molecular imaging of oncology targets has opened the door to more accurate disease assessment and the modernization of standard criteria for the evaluation, staging, and treatment responses of cancer patients. Furthermore, the introduction and validation of quantitative molecular imaging continues to drive and optimize the field of oncology diagnostics. Given their pivotal role in disease assessment and treatment, the validation and commercialization of diagnostic tools will continue to advance oncology clinical trials, support new oncology drugs, and promote better patient outcomes.

Fibroblast Activation Protein-Alpha, a Serine Protease that Facilitates Metastasis by Modification of Diverse Microenvironments

DTIC Science & Technology

2011-10-01

lung tissue. We were not able to detect sufficient numbers of cells in this manner. We tried a different procedure for fixing the lungs after they...added after 24 hours. The films were fixed and evaluated microscopically. In four trials, 10 random microscopic fields were selected and... dosing by oral gavage once daily with 1.3 mg/kg L-valine-L-boroproline called talabostat (extracellular & intracellular DASH), 13.3 mg/kg L- glutamyl

Spatial Repellency and the Field Evaluation of a Push-Pull Strategy for the Control of Malaria Vectors in Northern Belize, Central America

DTIC Science & Technology

2014-09-18

monitoring of knocked down mosquitoes. To control for residual chemical contamination from repellent treatments, all huts and interception traps were...to discontinue any ongoing trial if the institution is found to have contravened any of the above conditions. 7. The applicant shall cover food ...albopictus (Skuse) from Selangor, Malaysia . Trap Biomed 30:220-30 31. Cherington E, Ek E, Cho P, Burgess F, Hernandez B, et al. 2010. Forest Cover and

An Electronic Pillbox for Continuous Monitoring of Medication Adherence

PubMed Central

Hayes, Tamara. L.; Hunt, John M.; Adami, Andre; Kaye, Jeffrey A.

2010-01-01

We have developed an instrumented pillbox, called a MedTracker, which allows monitoring of medication adherence on a continuous basis. This device improves on existing systems by providing mobility, frequent and automatic data collection, more detailed information about nonadherence and medication errors, and the familiar interface of a 7-day drug store pillbox. We report on the design of the MedTracker, and on the results of a field trial in 39 homes to evaluate the device. PMID:17946369

Field evaluation of distance-estimation error during wetland-dependent bird surveys

USGS Publications Warehouse

Nadeau, Christopher P.; Conway, Courtney J.

2012-01-01

Context: The most common methods to estimate detection probability during avian point-count surveys involve recording a distance between the survey point and individual birds detected during the survey period. Accurately measuring or estimating distance is an important assumption of these methods; however, this assumption is rarely tested in the context of aural avian point-count surveys. Aims: We expand on recent bird-simulation studies to document the error associated with estimating distance to calling birds in a wetland ecosystem. Methods: We used two approaches to estimate the error associated with five surveyor's distance estimates between the survey point and calling birds, and to determine the factors that affect a surveyor's ability to estimate distance. Key results: We observed biased and imprecise distance estimates when estimating distance to simulated birds in a point-count scenario (x̄error = -9 m, s.d.error = 47 m) and when estimating distances to real birds during field trials (x̄error = 39 m, s.d.error = 79 m). The amount of bias and precision in distance estimates differed among surveyors; surveyors with more training and experience were less biased and more precise when estimating distance to both real and simulated birds. Three environmental factors were important in explaining the error associated with distance estimates, including the measured distance from the bird to the surveyor, the volume of the call and the species of bird. Surveyors tended to make large overestimations to birds close to the survey point, which is an especially serious error in distance sampling. Conclusions: Our results suggest that distance-estimation error is prevalent, but surveyor training may be the easiest way to reduce distance-estimation error. Implications: The present study has demonstrated how relatively simple field trials can be used to estimate the error associated with distance estimates used to estimate detection probability during avian point-count surveys. Evaluating distance-estimation errors will allow investigators to better evaluate the accuracy of avian density and trend estimates. Moreover, investigators who evaluate distance-estimation errors could employ recently developed models to incorporate distance-estimation error into analyses. We encourage further development of such models, including the inclusion of such models into distance-analysis software.

Effect of Novaluron (Rimon 10 EC) on the mosquitoes Anopheles albimanus, Anopheles pseudopunctipennis, Aedes aegypti, Aedes albopictus and Culex quinquefasciatus from Chiapas, Mexico.

PubMed

Arredondo-Jiménez, J I; Valdez-Delgado, K M

2006-12-01

Dengue fever is a serious problem in Mexico and vector control has not been effective enough at preventing outbreaks. Malaria is largely under control, but it is important that new control measures continue to be developed. Novaluron, a novel host-specific insect growth regulator and chitin synthesis inhibitor, has proved to be effective against agricultural pests, but its efficacy against larval mosquito vectors under field conditions remains unknown. In accordance with the World Health Organization Pesticide Evaluation Scheme, phase I, II and III studies were conducted to evaluate the efficacy and residual effect of Novaluron (Rimon 10 EC, Makhteshim, Beer-Sheva, Israel) on the malaria vectors Anopheles albimanus Wiedemann (Diptera: Culicidae) and Anopheles pseudopunctipennis Theobald, the dengue vectors Aedes aegypti (L) and Aedes albopictus Skuse and the nuisance mosquito Culex quinquefasciatus Say. Laboratory susceptibility tests yielded diagnostic concentrations for all five target species. Field trials to identify the optimum field dosage of Novaluron against Anopheles mosquitoes were carried out under semi-natural conditions in artificial plots and in vessels with wild mosquitoes. Efficacy was measured by monitoring mortality of larvae and pupae and the percentage of inhibition of emergence from floating cages. Dosages of Novaluron for field tests were based on pupal LC(99) (lethal concentration 99%) of An. pseudopunctipennis (0.166 mg/L) in plots and average pupal LC(99) of Ae. aegypti and Ae. albopictus (0.55 mg/L). At all dosages tested, Novaluron significantly reduced larval populations of An. albimanus, Culex coronator Dyar & Knab, Ae. albopictus and Cx. quinquefasciatus by approximately 90%, inhibited adult emergence of An. albimanus and An. pseudopunctipennis by approximately 97% for almost 4 months in experimental plots, and inhibited adult emergence of Ae. aegypti and Ae. albopictus by approximately 97% for up to 14 weeks. Recommended dosages of Novaluron for non-container breeding and container breeding mosquitoes are 0.166 mg/L and 0.55 mg/L, respectively. Overall, the residual effect was more sustained than that of temephos. The lowest dosage of Novaluron had less of an impact on non-target organisms than did temephos. Small-scale field trials in natural breeding sites treated with Novaluron at 0.6 L/ha eliminated adult emergence of An. albimanus and Cx. coronator for 8 weeks. For phase III studies, Novaluron was tested at the local and village levels, applying the optimum field rate to all natural breeding habitats within 1 km of a pair of neighbouring villages. Village-scale trials of Novaluron at 0.6 L/ha reduced An. albimanus larval populations for at least 8 weeks and, more importantly, sharply reduced the densities of adult host-seeking mosquitoes approaching houses. We conclude that Novaluron is effective and environmentally safer than temephos.

The role of risk communication planning in the release of the oral rabies vaccine in New Jersey: An evaluation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pflugh, K.K.

1995-12-01

Communicating health risk information is a complicated task. Citizen reaction to such information is difficult to predict, which makes it hard to plan an appropriate response. Research indicates that the way citizens respond to risk information often depends on whether the risk is familiar or unfamiliar, whether it is seen as imposed on them, whether it is man made or natural, or whether they have control over the risk. Potentially controversial cases that deal with delivering risk information have a special need for a well planned communication effort. Natural resource issues with an impact on public health are no exception.more » In New Jersey, a proposal to release an experimental bioengineered oral rabies vaccine for raccoons to test the effectiveness of the vaccine in halting the spread of rabies into an as yet unaffected area met with widespread public support and approval due in large part to the use of a unique risk communication planning process. This paper will describe the risk communication planning process used to gain public support and approval for release of oral rabies raccoon vaccine while focusing on the evaluation component of the process. The seven step process includes setting goals, profiling the issue or information gathering, audience identification and assessment, message development, method selection, implementation of the strategy and evaluation and follow-up. The goal of the evaluation component was to determine the effectiveness of the public information campaign on citizen`s knowledge of the field trial nearly three years after the initial announcement. In addition, it sought to learn citizen interest in maintaining the rabies free barrier that was created by the field trial using funds from local taxes. This evaluation includes the results of a mailed survey to 280 citizens, local officials and professional organizations. Finally, this paper will discuss the implications for future outreach efforts dealing complicated technical issues.« less

Type 1 Diabetes TrialNet--an international collaborative clinical trials network.

PubMed

Skyler, Jay S; Greenbaum, Carla J; Lachin, John M; Leschek, Ellen; Rafkin-Mervis, Lisa; Savage, Peter; Spain, Lisa

2008-12-01

Type 1 Diabetes TrialNet is an international consortium of clinical research centers aimed at the prevention or delay of type 1 diabetes (T1D). The fundamental goal of TrialNet is to counter the T1D disease process by immune modulation and/or enhancement of beta cell proliferation and regeneration. To achieve this goal, TrialNet researchers are working to better understand the natural history of the disease, to identify persons at risk, and to clinically evaluate novel therapies that balance potential risks and benefits. The particular focus is on studies of preventive measures. In addition, TrialNet evaluates therapies in individuals with newly diagnosed T1D with preserved beta cell function to help determine the risk/benefit profile and gain an initial assessment of potential efficacy in preservation of beta cell function, so that promising agents can be studied in prevention trials. In addition, TrialNet evaluates methodologies that enhance the conduct of its clinical trials, which includes tests of outcome assessment methodology, the evaluation of surrogate markers, and mechanistic studies laying the foundation for future clinical trials.

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

Field cage studies and progressive evaluation of genetically-engineered mosquitoes.

PubMed

Facchinelli, Luca; Valerio, Laura; Ramsey, Janine M; Gould, Fred; Walsh, Rachael K; Bond, Guillermo; Robert, Michael A; Lloyd, Alun L; James, Anthony A; Alphey, Luke; Scott, Thomas W

2013-01-01

A genetically-engineered strain of the dengue mosquito vector Aedes aegypti, designated OX3604C, was evaluated in large outdoor cage trials for its potential to improve dengue prevention efforts by inducing population suppression. OX3604C is engineered with a repressible genetic construct that causes a female-specific flightless phenotype. Wild-type females that mate with homozygous OX3604C males will not produce reproductive female offspring. Weekly introductions of OX3604C males eliminated all three targeted Ae. aegypti populations after 10-20 weeks in a previous laboratory cage experiment. As part of the phased, progressive evaluation of this technology, we carried out an assessment in large outdoor field enclosures in dengue endemic southern Mexico. OX3604C males were introduced weekly into field cages containing stable target populations, initially at 10:1 ratios. Statistically significant target population decreases were detected in 4 of 5 treatment cages after 17 weeks, but none of the treatment populations were eliminated. Mating competitiveness experiments, carried out to explore the discrepancy between lab and field cage results revealed a maximum mating disadvantage of up 59.1% for OX3604C males, which accounted for a significant part of the 97% fitness cost predicted by a mathematical model to be necessary to produce the field cage results. Our results indicate that OX3604C may not be effective in large-scale releases. A strain with the same transgene that is not encumbered by a large mating disadvantage, however, could have improved prospects for dengue prevention. Insights from large outdoor cage experiments may provide an important part of the progressive, stepwise evaluation of genetically-engineered mosquitoes.

Field Cage Studies and Progressive Evaluation of Genetically-Engineered Mosquitoes

PubMed Central

Facchinelli, Luca; Valerio, Laura; Ramsey, Janine M.; Gould, Fred; Walsh, Rachael K.; Bond, Guillermo; Robert, Michael A.; Lloyd, Alun L.; James, Anthony A.; Alphey, Luke; Scott, Thomas W.

2013-01-01

Background A genetically-engineered strain of the dengue mosquito vector Aedes aegypti, designated OX3604C, was evaluated in large outdoor cage trials for its potential to improve dengue prevention efforts by inducing population suppression. OX3604C is engineered with a repressible genetic construct that causes a female-specific flightless phenotype. Wild-type females that mate with homozygous OX3604C males will not produce reproductive female offspring. Weekly introductions of OX3604C males eliminated all three targeted Ae. aegypti populations after 10–20 weeks in a previous laboratory cage experiment. As part of the phased, progressive evaluation of this technology, we carried out an assessment in large outdoor field enclosures in dengue endemic southern Mexico. Methodology/Principal Findings OX3604C males were introduced weekly into field cages containing stable target populations, initially at 10∶1 ratios. Statistically significant target population decreases were detected in 4 of 5 treatment cages after 17 weeks, but none of the treatment populations were eliminated. Mating competitiveness experiments, carried out to explore the discrepancy between lab and field cage results revealed a maximum mating disadvantage of up 59.1% for OX3604C males, which accounted for a significant part of the 97% fitness cost predicted by a mathematical model to be necessary to produce the field cage results. Conclusions/Significance Our results indicate that OX3604C may not be effective in large-scale releases. A strain with the same transgene that is not encumbered by a large mating disadvantage, however, could have improved prospects for dengue prevention. Insights from large outdoor cage experiments may provide an important part of the progressive, stepwise evaluation of genetically-engineered mosquitoes. PMID:23350003

Systematic review on randomized controlled trials of coronary heart disease complicated with depression treated with Chinese herbal medicines.

PubMed

Wang, An-Lu; Chen, Zhuo; Luo, Jing; Shang, Qing-Hua; Xu, Hao

2016-01-01

This systemic review evaluated the efficacy and safety of Chinese herbal medicines (CHMs) in patients with coronary heart disease (CHD) complicated with depression. All databases were retrieved till September 30, 2014. Randomized controlled trials (RCTs) comparing CHMs with placebo or conventional Western medicine were retrieved. Data extraction, analyses and quality assessment were performed according to the Cochrane standards. RevMan 5.3 was used to synthesize the results. Thirteen RCTs enrolling 1,095 patients were included. Subgroup analysis was used to assess data. In reducing the degree of depression, CHMs showed no statistic difference in the 4th week [mean difference (MD)=-1.06; 95% confidence interval (CI)-2.38 to 0.26; n=501; I(2)=73%], but it was associated with a statistically significant difference in the 8th week (MD=-1.00; 95% CI-1.64 to-0.36; n=436; I(2)=48%). Meanwhile, the combination therapy (CHMs together with antidepressants) showed significant statistic differences both in the 4th week (MD=-1.99; 95% CI-3.80 to-0.18; n=90) and in the 8th week (MD=-5.61; 95% CI-6.26 to-4.97; n=242; I(2)=87%). In CHD-related clinical evaluation, 3 trials reported the intervention group was superior to the control group. Four trials showed adverse events in the intervention group was less than that in the control group. CHMs showed potentially benefits on patients with CHD complicated with depression. Moreover, the effect of CHMs may be similar to or better than antidepressant in certain fields but with less side effects. However, because of small sample size and potential bias of most trials, this result should be interpreted with caution. More rigorous trials with larger sample size and higher quality are warranted to give high quality of evidence to support the use of CHMs for CHD complicated with depression.

The effect of nutrition training for health care staff on learner and patient outcomes in adults: a systematic review and meta-analysis.

PubMed

Marples, Owen; Baldwin, Christine; Weekes, C Elizabeth

2017-07-01

Background: Nutrition training for health care staff has been prioritized internationally as a key means of tackling malnutrition; however, there is a lack of clear evidence to support its implementation. Systematic reviews in other fields of training for health care staff indicate that training strategies may have a beneficial impact on learner and patient outcomes. Objectives: We assessed whether nutrition training for health care staff caring for nutritionally vulnerable adults resulted in improved learner and patient outcomes and evaluated the effectiveness of different training strategies. Design: A systematic review of trials of nutrition training for health care staff was conducted. Six databases were searched with key terms relating to malnutrition and nutrition training. Studies were categorized according to cognitive (didactic teaching), behavioral (practical implementation of skills), and psychological (individualized or group feedback and reflection) training strategies. Where sufficient data were available, meta-analysis was performed according to study design and training strategy. All study designs were eligible. The risk of bias was evaluated in accordance with Cochrane guidance. Results: Twenty-four studies met the eligibility criteria: 1 randomized controlled trial, 4 nonrandomized controlled trials, 3 quasi-experimental trials, 13 longitudinal pre-post trials, 2 qualitative studies, and 1 cross-sectional survey. Results from a number of low-quality studies suggest that nutrition training for health care staff may have a beneficial effect on staff nutrition knowledge, practice, and attitude as well as patient nutritional intake. There were insufficient data to determine whether any particular training strategy was more effective than the others. Conclusions: In the absence of high-quality evidence, low-quality studies suggest that nutrition training for health care staff has some positive effects. However, further randomized controlled trials are required to confirm overall efficacy and to explore the impact of training strategies on learner and patient outcomes. © 2017 American Society for Nutrition.

Effects of a pulsed electromagnetic therapy on multiple sclerosis fatigue and quality of life: a double-blind, placebo controlled trial.

PubMed

Lappin, Martha S; Lawrie, Fraser Wilson; Richards, Todd L; Kramer, Eric D

2003-01-01

There is a growing literature on the biological and clinical effects of pulsed electromagnetic fields. Some studies suggest that electromagnetic therapies may be useful in the treatment of chronic illnesses. This study is a follow-up to a placebo controlled pilot study in which multiple sclerosis (MS) patients exposed to weak, extremely low frequency pulsed electromagnetic fields showed significant improvements on a composite symptom measure. To evaluate the effects of a pulsed electromagnetic therapy on MS related fatigue, spasticity, bladder control, and overall quality of life. A multi-site, double-blind, placebo controlled, crossover trial. Each subject received 4 weeks of the active and placebo treatments separated by a 2-week washout period. The University of Washington Medical Center in Seattle Wash, the Neurology Center of Fairfax in Fairfax, Va, and the headquarters of the Multiple Sclerosis Association of America in Cherry Hill, NJ. 117 patients with clinically definite MS. Daily exposure to a small, portable pulsing electromagnetic field generator. The MS Quality of Life Inventory (MSQLI) was used to assess changes in fatigue, bladder control, spasticity, and a quality of life composite. Paired t-tests were used to assess treatment differences in the 117 subjects (81% of the initial sample) who completed both treatment sessions. Improvements in fatigue and overall quality of life were significantly greater on the active device. There were no treatment effects for bladder control and a disability composite, and mixed results for spasticity. Evidence from this randomized, double-bind, placebo controlled trial is consistent with results from smaller studies suggesting that exposure to pulsing, weak electromagnetic fields can alleviate symptoms of MS. The clinical effects were small, however, and need to be replicated. Additional research is also needed to examine the possibility that ambulatory patients and patients taking interferons for their MS may be most responsive to this kind of treatment.

Development of a flattening filter free multiple source model for use as an independent, Monte Carlo, dose calculation, quality assurance tool for clinical trials.

PubMed

Faught, Austin M; Davidson, Scott E; Popple, Richard; Kry, Stephen F; Etzel, Carol; Ibbott, Geoffrey S; Followill, David S

2017-09-01

The Imaging and Radiation Oncology Core-Houston (IROC-H) Quality Assurance Center (formerly the Radiological Physics Center) has reported varying levels of compliance from their anthropomorphic phantom auditing program. IROC-H studies have suggested that one source of disagreement between institution submitted calculated doses and measurement is the accuracy of the institution's treatment planning system dose calculations and heterogeneity corrections used. In order to audit this step of the radiation therapy treatment process, an independent dose calculation tool is needed. Monte Carlo multiple source models for Varian flattening filter free (FFF) 6 MV and FFF 10 MV therapeutic x-ray beams were commissioned based on central axis depth dose data from a 10 × 10 cm 2 field size and dose profiles for a 40 × 40 cm 2 field size. The models were validated against open-field measurements in a water tank for field sizes ranging from 3 × 3 cm 2 to 40 × 40 cm 2 . The models were then benchmarked against IROC-H's anthropomorphic head and neck phantom and lung phantom measurements. Validation results, assessed with a ±2%/2 mm gamma criterion, showed average agreement of 99.9% and 99.0% for central axis depth dose data for FFF 6 MV and FFF 10 MV models, respectively. Dose profile agreement using the same evaluation technique averaged 97.8% and 97.9% for the respective models. Phantom benchmarking comparisons were evaluated with a ±3%/2 mm gamma criterion, and agreement averaged 90.1% and 90.8% for the respective models. Multiple source models for Varian FFF 6 MV and FFF 10 MV beams have been developed, validated, and benchmarked for inclusion in an independent dose calculation quality assurance tool for use in clinical trial audits. © 2017 American Association of Physicists in Medicine.

Therapeutic effects of antimicrobial treatment during lactation of recently acquired bovine subclinical mastitis: two linked randomized field trials.

PubMed

van den Borne, B H P; van Schaik, G; Lam, T J G M; Nielen, M

2010-01-01

Two linked randomized field trials were performed on 39 herds in the Netherlands to 1) determine therapeutic effects of antimicrobial treatment of recently acquired subclinical mastitis (RASCM) during lactation, 2) evaluate the effect of duration of subclinical mastitis on therapeutic outcome, and 3) identify factors related to the therapeutic success of RASCM. Cows with a first elevated composite somatic cell count (CSCC) after 2 consecutive low CSCC measurements were eligible for enrollment in trial 1 (treatment at the first elevated CSCC). Quarter milk samples were collected to determine bacteriological status for major pathogens and coagulase-negative staphylococci. Cows with one or more culture-positive quarters with a quarter somatic cell count (QSCC) >or=100,000 cells/mL were defined to have RASCM and were randomly assigned treatment or control (no treatment). Untreated cows from trial 1 that had a second elevated CSCC at the next milk recording were eligible for enrollment in trial 2 (treatment at the second elevated CSCC). In trial 2, staphylococci-positive cows (Staphylococcus aureus and coagulase-negative staphylococci) were randomly assigned to treatment or control. Farmers used their own treatment protocols to treat quarters in both trials. Bacteriological cure was defined as absence of the pathogen identified pre-intervention in 2 samples post-intervention; QSCC, CSCC, and milk yield were also analyzed. Hierarchical logistic and linear models were used to determine therapeutic effects and to identify factors related to therapy outcome. Treated quarters had a higher bacteriological cure rate than control quarters for all pathogens in both trials. Treatment resulted in lower QSCC and CSCC, whereas milk yield was not affected by treatment. Bacteriological cure of RASCM was better in quarters with a low QSCC pre-intervention and in coagulase-negative staphylococci-positive quarters. Control quarters with a single culture-positive sample pre-intervention also had a higher bacteriological cure than control quarters with >or=2 culture-positive samples. Time of antimicrobial treatment affected bacteriological cure for penicillin-sensitive Staph. aureus. Bacteriological cure tended to be higher for Staph. aureus after treatment at the first elevated CSCC compared with treatment at the second elevated CSCC. Thus, early treatment of Staph. aureus might be more effective than later treatment. Copyright 2010 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

Impact of a clinical trial initiative on clinical trial enrollment in a multidisciplinary prostate cancer clinic.

PubMed

Madsen, Lydia T; Kuban, Deborah A; Choi, Seungtaek; Davis, John W; Kim, Jeri; Lee, Andrew K; Domain, Delora; Levy, Larry; Pisters, Louis L; Pettaway, Curtis A; Ward, John F; Logothetis, Christopher; Hoffman, Karen E

2014-07-01

Clinical oncology trials are hampered by low accrual rates, with fewer than 5% of adult patients with cancer treated on study. Clinical trial enrollment was evaluated at The University of Texas MD Anderson Cancer Center's Multidisciplinary Prostate Cancer Clinic (MPCC) to assess whether a clinical trial initiative, introduced in 2006, impacted enrollment. The trial initiative included posting trial-specific information in clinic, educating patients about appropriate clinical trial options during the treatment recommendation discussion, and providing patients with trial-specific educational information. The investigators evaluated the frequency of clinical trial enrollment for men with newly diagnosed prostate cancer seen in the MPCC from 2004 to 2008. Logistic regression evaluated the impact of patient characteristics and the clinical trial initiative on trial enrollment. The median age of the 1370 men was 64 years; 32% had low-risk, 49% had intermediate-risk, and 19% had high-risk disease. Overall, 74% enrolled in at least one trial and 29% enrolled in more than one trial. Trial enrollment increased from 39% before the initiative (127/326) to 84% (880/1044) after the trial initiative. Patient enrollment increased in laboratory studies (from 25% to 80%), quality-of-life studies (from 10% to 26%), and studies evaluating investigational treatments and systemic agents (from 6% to 15%) after the trial initiative. In multivariate analysis, younger men (P<.001) and men seen after implementation of the clinical trial initiative (P<.001) were more likely to enroll in trials. Clinical trial enrollment in the MPCC was substantially higher than that seen nationally in adult patients with cancer, and enrollment rates increased after the introduction of a clinical trial initiative. Copyright © 2014 by the National Comprehensive Cancer Network.

How product trial changes quality perception of four new processed beef products.

PubMed

Saeed, Faiza; Grunert, Klaus G; Therkildsen, Margrethe

2013-01-01

The purpose of this paper is the quantitative analysis of the change in quality perception of four new processed beef products from pre to post trial phases. Based on the Total Food Quality Model, differences in pre and post-trial phases were measured using repeated measures technique for cue evaluation, quality evaluation and purchase motive fulfillment. For two of the tested products, trial resulted in a decline of the evaluation of cues, quality and purchase motive fulfillment compared to pre-trial expectations. For these products, positive expectations were created by giving information about ingredients and ways of processing, which were not confirmed during trial. For the other two products, evaluations on key sensory dimensions based on trial exceeded expectations, whereas the other evaluations remained unchanged. Several demographic factors influenced the pattern of results, notably age and gender, which may be due to underlying differences in previous experience. The study gives useful insights for testing of new processed meat products before market introduction. Copyright © 2012 Elsevier Ltd. All rights reserved.

Systematic review of the cost effectiveness of prophylactic treatments in the prevention of gastropathy in patients with rheumatoid arthritis or osteoarthritis taking non-steroidal anti-inflammatory drugs

PubMed Central

van Dieten, H. E M; Bos, I.; van Tulder, M. W; Lems, W.; Dijkmans, B.; Boers, M.

2000-01-01

A systematic review on the cost effectiveness of prophylactic treatments of non-steroidal anti-inflammatory drug (NSAID) induced gastropathy in patients with osteoarthritis or rheumatoid arthritis was conducted. Two reviewers conducted the literature search and the review. Both full and partial economic evaluations published in English, Dutch, or German were included. The criteria list published in the textbook of Drummond was used to determine the quality of the economic evaluations. The methodological quality of three randomised controlled trials (RCTs) in which the economic evaluations obtained probability estimates of NSAID induced gastropathy and adverse events was assessed by a list of internal validity criteria. The conclusions were based on a rating system consisting of four levels of evidence.
  Ten economic evaluations were included; three were based on RCTs. All evaluations studied misoprostol as prophylactic treatment: in one evaluation misoprostol was studied as a fixed component in a combination with diclofenac (Arthrotec). All economic evaluations comprised analytical studies containing a decision tree. The three trials were of high methodological quality. Nine economic evaluations were considered high quality and one economic evaluation was considered of low methodological quality. There is strong evidence (level "A") that the use of misoprostol for the prevention of NSAID induced gastropathy is cost effective, and limited evidence (level "C") that the use of Arthrotec is cost effective. Although the levels of evidence used in this review are arbitrary, it is believed that a qualitative analysis is useful: quantitative analyses in this field are hampered by the heterogeneity of economic evaluations. Existing criteria to evaluate the methodological quality of economic evaluations may need refinement for use in systematic reviews.

 PMID:11005773

Systematic review of the cost effectiveness of prophylactic treatments in the prevention of gastropathy in patients with rheumatoid arthritis or osteoarthritis taking non-steroidal anti-inflammatory drugs.

PubMed

van Dieten, H E; Korthals-de Bos, I B; van Tulder, M W; Lems, W F; Dijkmans, B A; Boers, M

2000-10-01

A systematic review on the cost effectiveness of prophylactic treatments of non-steroidal anti-inflammatory drug (NSAID) induced gastropathy in patients with osteoarthritis or rheumatoid arthritis was conducted. Two reviewers conducted the literature search and the review. Both full and partial economic evaluations published in English, Dutch, or German were included. The criteria list published in the textbook of Drummond was used to determine the quality of the economic evaluations. The methodological quality of three randomised controlled trials (RCTs) in which the economic evaluations obtained probability estimates of NSAID induced gastropathy and adverse events was assessed by a list of internal validity criteria. The conclusions were based on a rating system consisting of four levels of evidence. Ten economic evaluations were included; three were based on RCTs. All evaluations studied misoprostol as prophylactic treatment: in one evaluation misoprostol was studied as a fixed component in a combination with diclofenac (Arthrotec). All economic evaluations comprised analytical studies containing a decision tree. The three trials were of high methodological quality. Nine economic evaluations were considered high quality and one economic evaluation was considered of low methodological quality. There is strong evidence (level "A") that the use of misoprostol for the prevention of NSAID induced gastropathy is cost effective, and limited evidence (level "C") that the use of Arthrotec is cost effective. Although the levels of evidence used in this review are arbitrary, it is believed that a qualitative analysis is useful: quantitative analyses in this field are hampered by the heterogeneity of economic evaluations. Existing criteria to evaluate the methodological quality of economic evaluations may need refinement for use in systematic reviews.

Methodology of clinical trials evaluating the incorporation of new drugs in the first-line treatment of patients with diffuse large B-cell lymphoma (DLBCL): a critical review.

PubMed

Iacoboni, G; Zucca, E; Ghielmini, M; Stathis, A

2018-05-01

The first-line treatment of diffuse large B-cell lymphoma (DLBCL) is the combination of rituximab with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy, curing approximately 60% of patients. Many clinical trials have been carried out over the last 10 years trying to improve the results of this treatment, but the appropriateness of their planning strategies could be rediscussed. Reports of phase III trials evaluating the addition of molecularly targeted agents or new monoclonal antibodies to the classic R-CHOP backbone in first-line induction or maintenance treatment were reviewed. The trial design, primary end point, number of patients enrolled, patient selection criteria, treatment schedule and results were registered for each one. In addition, the phases I and II trials which preceded these phase III trials were also reviewed. Among six phase III trials with results, only one trial evaluating lenalidomide maintenance after response to R-CHOP induction was positive and reached its primary end point. The other five trials did not show an improved outcome with the addition of the new agent. The preceding phases I and II trials were very heterogeneous in their end points and design. Even though most of these trials were considered positive, thus encouraging further investigation, so far they failed to predict the results of the subsequent phase III trials. The standard of care for DLBCL is still R-CHOP. Phase I/II trials failed to predict the results of subsequent phase III trials evaluating non-chemotherapeutic agents added to R-CHOP. The methodology of phase II trials evaluating new agents in DLBCL needs to be better defined in the future.

High-Throughput Analytical Techniques for the Determination of the Residues of 653 Multiclass Pesticides and Chemical Pollutants in Tea, Part VII: A GC-MS, GC-MS/MS, and LC-MS/MS Study of the Degradation Profiles of Pesticide Residues in Green Tea.

PubMed

Chang, Qiao-Ying; Pang, Guo-Fang; Fan, Chun-Lin; Chen, Hui; Yang, Fang; Li, Jie; Wen, Bi-Fang

2016-11-01

GC-MS, GC-tandem MS (MS/MS), and LC-MS/MS were used to mathematically define the degradation profiles of pesticide residues in two field trials. Nineteen pesticides were studied in the first field trial and 11 in the second. The results of the field trials demonstrated that the degradation profiles of pesticide residues in green tea can be described with power functions to successfully estimate the amount of time, following pesticide application, pesticide residues appearing in tea in concentrations at and/or above the maximum residue limit (MRL) decrease to concentrations below the MRL. Stability tests on green tea samples stored at room temperature were conducted to determine whether pesticide-incurred green tea samples prepared according to the method used in the field trials would be suitable for the preparation of reference standards for laboratory-proficiency testing trials. This paper reports the results of a GC-MS, GC-MS/MS, and LC-MS/MS study, as well as the suitability of the samples prepared under these conditions for use as pesticide reference standards in tea analysis.

Strategies to improve retention in randomised trials.

PubMed

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

2013-12-03

Loss to follow-up from randomised trials can introduce bias and reduce study power, affecting the generalisability, validity and reliability of results. Many strategies are used to reduce loss to follow-up and improve retention but few have been formally evaluated. To quantify the effect of strategies to improve retention on the proportion of participants retained in randomised trials and to investigate if the effect varied by trial strategy and trial setting. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PreMEDLINE, EMBASE, PsycINFO, DARE, CINAHL, Campbell Collaboration's Social, Psychological, Educational and Criminological Trials Register, and ERIC. We handsearched conference proceedings and publication reference lists for eligible retention trials. We also surveyed all UK Clinical Trials Units to identify further studies. We included eligible retention trials of randomised or quasi-randomised evaluations of strategies to increase retention that were embedded in 'host' randomised trials from all disease areas and healthcare settings. We excluded studies aiming to increase treatment compliance. We contacted authors to supplement or confirm data that we had extracted. For retention trials, we recorded data on the method of randomisation, type of strategy evaluated, comparator, primary outcome, planned sample size, numbers randomised and numbers retained. We used risk ratios (RR) to evaluate the effectiveness of the addition of strategies to improve retention. We assessed heterogeneity between trials using the Chi(2) and I(2) statistics. For main trials that hosted retention trials, we extracted data on disease area, intervention, population, healthcare setting, sequence generation and allocation concealment. We identified 38 eligible retention trials. Included trials evaluated six broad types of strategies to improve retention. These were incentives, communication strategies, new questionnaire format, participant case management, behavioural and methodological interventions. For 34 of the included trials, retention was response to postal and electronic questionnaires with or without medical test kits. For four trials, retention was the number of participants remaining in the trial. Included trials were conducted across a spectrum of disease areas, countries, healthcare and community settings. Strategies that improved trial retention were addition of monetary incentives compared with no incentive for return of trial-related postal questionnaires (RR 1.18; 95% CI 1.09 to 1.28, P value < 0.0001), addition of an offer of monetary incentive compared with no offer for return of electronic questionnaires (RR 1.25; 95% CI 1.14 to 1.38, P value < 0.00001) and an offer of a GBP20 voucher compared with GBP10 for return of postal questionnaires and biomedical test kits (RR 1.12; 95% CI 1.04 to 1.22, P value < 0.005). The evidence that shorter questionnaires are better than longer questionnaires was unclear (RR 1.04; 95% CI 1.00 to 1.08, P value = 0.07) and the evidence for questionnaires relevant to the disease/condition was also unclear (RR 1.07; 95% CI 1.01 to 1.14). Although each was based on the results of a single trial, recorded delivery of questionnaires seemed to be more effective than telephone reminders (RR 2.08; 95% CI 1.11 to 3.87, P value = 0.02) and a 'package' of postal communication strategies with reminder letters appeared to be better than standard procedures (RR 1.43; 95% CI 1.22 to 1.67, P value < 0.0001). An open trial design also appeared more effective than a blind trial design for return of questionnaires in one fracture prevention trial (RR 1.37; 95% CI 1.16 to 1.63, P value = 0.0003).There was no good evidence that the addition of a non-monetary incentive, an offer of a non-monetary incentive, 'enhanced' letters, letters delivered by priority post, additional reminders, or questionnaire question order either increased or decreased trial questionnaire response/retention. There was also no evidence that a telephone survey was either more or less effective than a monetary incentive and a questionnaire. As our analyses are based on single trials, the effect on questionnaire response of using offers of charity donations, sending reminders to trial sites and when a questionnaire is sent, may need further evaluation. Case management and behavioural strategies used for trial retention may also warrant further evaluation. Most of the retention trials that we identified evaluated questionnaire response. There were few evaluations of ways to improve participants returning to trial sites for trial follow-up. Monetary incentives and offers of monetary incentives increased postal and electronic questionnaire response. Some other strategies evaluated in single trials looked promising but need further evaluation. Application of the findings of this review would depend on trial setting, population, disease area, data collection and follow-up procedures.

Influence of the operatory field isolation technique on tooth-colored direct dental restorations.

PubMed

Cajazeira, Marlus Roberto Rodrigues; De Sabóia, Ticiana Medeiros; Maia, Lucianne Cople

2014-06-01

To evaluate, through a systematic review, the influence of the operatory field isolation technique on the longevity of dental restorations performed with tooth-colored materials. An electronic search of the scientific databases (MEDLINE, SCIRUS, VHL and SIGLE) and reference lists of the selected articles was conducted to identify randomized controlled clinical trials with a follow-up period of at least 12 months. The selected articles evaluated the effects of the operatory field isolation techniques (rubber dam or cotton rolls/saliva ejector) on the longevity of direct restorations performed with tooth-colored materials (e.g. resin composites, compomers and glass-ionomer cements) in primary or permanent posterior teeth. The selected studies were analyzed and categorized using a checklist proposed by the National Institute for Health and Clinical Excellence of the United Kingdom. 484 studies were identified on the scientific databases. After applying the exclusion criteria and removal of duplicates, a total of nine studies were considered as potentially eligible. From these, five studies were included in the final analysis by two evaluators. In four studies analyzed, the use of rubber dam did not influence the longevity of restorations in comparison to cotton rolls/saliva ejector. Only two studies were considered as low risk of bias.

[Methodological quality and reporting quality evaluation of randomized controlled trials published in China Journal of Chinese Materia Medica].

PubMed

Yu, Dan-Dan; Xie, Yan-Ming; Liao, Xing; Zhi, Ying-Jie; Jiang, Jun-Jie; Chen, Wei

2018-02-01

To evaluate the methodological quality and reporting quality of randomized controlled trials(RCTs) published in China Journal of Chinese Materia Medica, we searched CNKI and China Journal of Chinese Materia webpage to collect RCTs since the establishment of the magazine. The Cochrane risk of bias assessment tool was used to evaluate the methodological quality of RCTs. The CONSORT 2010 list was adopted as reporting quality evaluating tool. Finally, 184 RCTs were included and evaluated methodologically, of which 97 RCTs were evaluated with reporting quality. For the methodological evaluating, 62 trials(33.70%) reported the random sequence generation; 9(4.89%) trials reported the allocation concealment; 25(13.59%) trials adopted the method of blinding; 30(16.30%) trials reported the number of patients withdrawing, dropping out and those lost to follow-up;2 trials （1.09%） reported trial registration and none of the trial reported the trial protocol; only 8(4.35%) trials reported the sample size estimation in details. For reporting quality appraising, 3 reporting items of 25 items were evaluated with high-quality,including: abstract, participants qualified criteria, and statistical methods; 4 reporting items with medium-quality, including purpose, intervention, random sequence method, and data collection of sites and locations; 9 items with low-quality reporting items including title, backgrounds, random sequence types, allocation concealment, blindness, recruitment of subjects, baseline data, harms, and funding;the rest of items were of extremely low quality(the compliance rate of reporting item<10%). On the whole, the methodological and reporting quality of RCTs published in the magazine are generally low. Further improvement in both methodological and reporting quality for RCTs of traditional Chinese medicine are warranted. It is recommended that the international standards and procedures for RCT design should be strictly followed to conduct high-quality trials. At the same time, in order to improve the reporting quality of randomized controlled trials, CONSORT standards should be adopted in the preparation of research reports and submissions. Copyright© by the Chinese Pharmaceutical Association.

Responses of Conophthorus spp. (Coleoptera: Scolytidae) to behavioral chemicals in field trials: a transcontinental perspective

Treesearch

Nancy G. Rappaport; John D. Stein; Adolfo Arturo del Rio Mora; Gary DeBarr; Peter de Groot; Sylvia Mori

2000-01-01

We tested six behavioral chemicals, pityol, conophthorin, 4-allylanisole, verbenone, 2-hexenol, and á-pinene, in a series of field trials directed at six combinations of Conophthorus Hopkins - Pinus L. spp. (Pinaceae) in sites distributed across North America. Beetle - host tree combinations included Conophthorus...

Implementing Interactive Telecommunications Services. Final Report on Problems Which Arise During Implementation of Field Trials and Demonstration Projects.

ERIC Educational Resources Information Center

Elton, Martin C. J.; Carey, John

Intended primarily for use by individuals about to assume responsibility for the implementation of field trials and demonstration projects built around interactive telecommunication systems, this report provides brief descriptions of 20 telemedicine projects, 12 teleconferencing projects, and seven involving two-way applications of cable…

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

USDA-ARS?s Scientific Manuscript database

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 ...

Olfactory source localization in the open field using one or both nostrils.

PubMed

Welge-Lussen, A; Looser, G L; Westermann, B; Hummel, T

2014-03-01

This study aims to examine humans ́ abilities to localize odorants within the open field. Young participants were tested on a localization task using a relatively selective olfactory stimulus (2-phenylethyl-alcohol, PEA) and cineol, an odorant with a strong trigeminal component. Participants were blindfolded and had to localize an odorant source at 2 m distance (far-field condition) and a 0.4 m distance (near-field condition) with either two nostrils open or only one open nostril. For the odorant with trigeminal properties, the number of correct trials did not differ when one or both nostrils were used, while more PEA localization trials were correctly completed with both rather than one nostril. In the near-field condition, correct localization was possible in 72-80% of the trials, irrespective of the odorant and the number of nostrils used. Localization accuracy, measured as spatial deviation from the olfactory source, was significantly higher in the near-field compared to the far-field condition, but independent of the odorant being localized. Odorant localization within the open field is difficult, but possible. In contrast to the general view, humans seem to be able to exploit the two-nostril advantage with increasing task difficulty.

Clinical trials of GMP products in the gene therapy field.

PubMed

Bamford, Kathleen B

2011-01-01

Advances in gene therapy are increasingly leading to clinical assessment in many fields of medicine with diverse approaches. The basic science stems from approaches aimed at different functions such as correcting a missing/abnormal gene, altering the proportion or expression of normal genes to augment a physiological process or using this principle to destroy malignant or infected cells. As the technology advances, it is increasingly important to ensure that clinical trials answer the questions that need to be asked. In this chapter we review examples of published clinical trials, resources for accessing information about registered trials, the process of regulating trials, good clinical practice, and good manufacturing practice as well as summarising the approach taken by regulatory authorities in reviewing applications for the introduction of products for use in the clinic.

Asphalt additives in thick hot mixed asphalt-concrete pavements. Research report (Interim), Sep 86-Oct 90

DOE Office of Scientific and Technical Information (OSTI.GOV)

Button, J.W.; Prapnnachari, S.

Asphalt concrete field test pavements were placed in District 19 north of Texarkana on US-59/71 in 1987 and 1988 to evaluate the ability of certain asphalt additives to enhance resistance to cracking and rutting. Two 10-inch thick and 0.9 mile (approx.) long test pavements and a similar untreated control section were constructed in the northbound and southbound lanes for a total of 6 field trials. Asphalt additives were incorporated in both the 8-inch base and the overlying 2-inch surface layers. The additives evaluated included Goodyear LPF 5812, Chemkrete-CTI 102, Exxon Polybilt 102, and Styrelf 13. Samples of paving materials includingmore » aggregates, asphalts, compacted mixes, and pavement cores were collected, conveyed to the laboratory, and tested to provide detailed documentation of their properties. Tests included rheological properties of the binders before and after artificial aging, characterization of aggregate, Hveem and Marshall stability, stiffness as a function of temperature, tensile properties before and after moisture conditioning and artificial aging, air void content, creep, and permanent deformation. Field tests and visual evaluations have been conducted to objectively evaluate field performance. Results of these tests are reported herein. Within 6 months after construction of the base layers and prior to placement of the surface course, the Chemkrete modified base became severely cracked. As a result, the surface mix placed on this base section was treated with Goodyear latex rather than Chemkrete. All other modified pavements and the control section have performed well and exhibited essentially equivalent performance after 2 1/2 years in service.« less

Prediction of functional loss in glaucoma from progressive optic disc damage.

PubMed

Medeiros, Felipe A; Alencar, Luciana M; Zangwill, Linda M; Bowd, Christopher; Sample, Pamela A; Weinreb, Robert N

2009-10-01

To evaluate the ability of progressive optic disc damage detected by assessment of longitudinal stereophotographs to predict future development of functional loss in those with suspected glaucoma. The study included 639 eyes of 407 patients with suspected glaucoma followed up for an average of 8.0 years with annual standard automated perimetry visual field and optic disc stereophotographs. All patients had normal and reliable standard automated perimetry results at baseline. Conversion to glaucoma was defined as development of 3 consecutive abnormal visual fields during follow-up. Presence of progressive optic disc damage was evaluated by grading longitudinally acquired simultaneous stereophotographs. Other predictive factors included age, intraocular pressure, central corneal thickness, pattern standard deviation, and baseline stereophotograph grading. Hazard ratios for predicting visual field loss were obtained by extended Cox models, with optic disc progression as a time-dependent covariate. Predictive accuracy was evaluated using a modified R(2) index. Progressive optic disc damage had a hazard ratio of 25.8 (95% confidence interval, 16.0-41.7) and was the most important risk factor for development of visual field loss with an R(2) of 79%. The R(2)s for other predictive factors ranged from 6% to 26%. Presence of progressive optic disc damage on stereophotographs was a highly predictive factor for future development of functional loss in glaucoma. These findings suggest the importance of careful monitoring of the optic disc appearance and a potential role for longitudinal assessment of the optic disc as an end point in clinical trials and as a reference for evaluation of diagnostic tests in glaucoma.

The effectiveness of non-surgical interventions in the treatment of Charcot foot.

PubMed

Smith, Caroline; Kumar, Saravana; Causby, Ryan

2007-12-01

Background  Charcot neuropathic osteoarthropathy is commonly known as 'Charcot foot'. It is a serious foot complication of diabetes mellitus that can frequently lead to foot ulceration, gangrene, hospital admission and foot amputation. A multidisciplinary approach to the management of Charcot foot is taken involving medical and allied health professionals. The management approach may also differ between different countries. To date, there is no systematic review of the literature undertaken to identify the clinical effectiveness of non-operative interventions in the treatment of acute Charcot foot. Objective  The objective of this review was to identify the effectiveness of non-surgical interventions with reducing lesions, ulceration, the rate of surgical intervention, reducing hospital admissions and improve the quality of life of subjects with Charcot foot. Search strategy  A comprehensive search strategy was undertaken on databases available from University of South Australia from their inception to November 2006. Selection criteria  Randomised controlled trials or clinical controlled trials were primarily sought. Critical appraisal of study quality and data extraction was undertaken using Joanna Briggs Institute instruments. Review Manager software was used to calculate comparative statistics. Results  This review identified 11 trials and five trials were included in the review. Three trials involved the use of bisphosphonate, a pharmacological agent. Two experimental treatments were also included, evaluating palliative radiology and magnetic fields. No trials were found using immobilisation and off-loading interventions for acute Charcot foot. The overall methodological quality score of the five studies was moderate. Owing to heterogeneous data, meta-analysis could not be performed. The trials did not report on reducing lesions, ulceration, rate of surgical intervention, hospital admissions and the quality of life of subjects with Charcot foot. The trials evaluating bisphosphonates reported greater reduction in foot temperature and disease activity for intervention subjects compared with controls. Another outcome of this review indicated additional beneficial effects of bisphosphonates in reducing pain and discomfort. The trial evaluating palliative radiotherapy found no difference between groups on any outcome. A significant reduction in the amount of deformity and reduced healing time to consolidation was found after treatment in the group receiving magnetic therapy treatment. Discussion  There is a lack of clinical trials evaluating the effectiveness of non-operative interventions for the management of Charcot foot (immobilisation, removable cast walkers, advice/dispensing of footwear and prescribing of orthotics). Bisphosphonates may be useful adjuncts to standard management of Charcot foot by improved healing demonstrated by a reduction in disease activity indicated by skin temperature and bone destruction. Magnetic therapy may reduce deformity, joint destruction and improve mobility. Conclusion  There is a lack of evidence supporting the use of pharmacological or non-surgical interventions with reducing lesions, ulceration, rate of surgical intervention, hospital admissions and improving the quality of life of subjects with Charcot foot. Bisphosphonates may improve the healing of Charcot foot by reducing skin temperature and disease activity of Charcot foot, when applied in addition to standard interventions to control the position and shape of the foot.

The effect of paramedic training on pre-hospital trauma care (EPPTC-study): a study protocol for a prospective semi-qualitative observational trial

PubMed Central

2014-01-01

Background Accidents are the leading cause of death in adults prior to middle age. The care of severely injured patients is an interdisciplinary challenge. Limited evidence is available concerning pre-hospital trauma care training programs and the advantage of such programs for trauma patients. The effect on trauma care procedures or on the safety of emergency crews on the scene is limited; however, there is a high level of experience and expert opinion. Methods I – Video-recorded case studies are the basis of an assessment tool and checklist being developed to verify the results of programs to train participants in the care of seriously injured patients, also known as “objective structured clinical examination” (OSCE). The timing, completeness and quality of the individual measures are assessed using appropriate scales. The evaluation of team communication and interaction will be analyzed with qualitative methods and quantified and verified by existing instruments (e.g. the Clinical Team Scale). The developed assessment tool is validated by several experts in the fields of trauma care, trauma research and medical education. II a) In a German emergency medical service, the subjective assessment of paramedics of their pre-hospital care of trauma patients is evaluated at three time points, namely before, immediately after and one year after training. b) The effect of a standardized course concept on the quality of documentation in actual field operations is determined based on three items relevant to patient safety before and after the course. c) The assessment tool will be used to assess the effect of a standardized course concept on procedures and team communication in pre-hospital trauma care using scenario-based case studies. Discussion This study explores the effect of training on paramedics. After successful study completion, further multicenter studies are conceivable, which would evaluate emergency-physician staffed teams. The influence on the patients and prehospital measures should be assessed based on a retrospective analysis of the emergency room data. Trials registration German Clinical Trials Register, ID DRKS00004713. PMID:24528532

A field efficacy evaluation of emamectin benzoate for the control of sea lice on Atlantic salmon.

PubMed

Armstrong, R; MacPhee, D; Katz, T; Endris, R

2000-08-01

This study evaluated the efficacy of emamectin benzoate, 0.2% aquaculture premix, against sea lice on Atlantic salmon in eastern Canada. Salmon pens received either emamectin benzoate, orally, in feed at 50 micrograms/kg body weight/day for 7 consecutive days, or the same diet with no added medication. The site veterinarian had the option of administering a bath treatment with azamethiphos to any pen in the trial. The mean number of lice per fish was lower (P < 0.05) in the experimental group when measured 1, 3, 4, and 6 weeks after the start of medication. Treatment efficacy was 70%, 88%, 95%, and 61%, respectively. Three azamethiphos bath treatments were applied to each control pen during the trial, while the treatment pens received no bath treatment. No gravid female parasites were observed on any fish in the treatment group, while these life stages were observed on fish in the control group. Orally administered emamectin benzoate was palatable and highly effective for control of sea lice on salmon.

A field efficacy evaluation of emamectin benzoate for the control of sea lice on Atlantic salmon.

PubMed Central

Armstrong, R; MacPhee, D; Katz, T; Endris, R

2000-01-01

This study evaluated the efficacy of emamectin benzoate, 0.2% aquaculture premix, against sea lice on Atlantic salmon in eastern Canada. Salmon pens received either emamectin benzoate, orally, in feed at 50 micrograms/kg body weight/day for 7 consecutive days, or the same diet with no added medication. The site veterinarian had the option of administering a bath treatment with azamethiphos to any pen in the trial. The mean number of lice per fish was lower (P < 0.05) in the experimental group when measured 1, 3, 4, and 6 weeks after the start of medication. Treatment efficacy was 70%, 88%, 95%, and 61%, respectively. Three azamethiphos bath treatments were applied to each control pen during the trial, while the treatment pens received no bath treatment. No gravid female parasites were observed on any fish in the treatment group, while these life stages were observed on fish in the control group. Orally administered emamectin benzoate was palatable and highly effective for control of sea lice on salmon. PMID:10945125

The Interaction of Arousal and Valence in Affective Priming: Behavioral and Electrophysiological Evidence

PubMed Central

Zhang, Qin; Kong, Lingyue; Jiang, Yang

2013-01-01

The affective priming paradigm has been studied extensively and applied in many fields during the past two decades. Most research thus far has focused on the valence dimension. Whether emotional arousal influences affective priming remains poorly understood. The present study demonstrates how arousal impacts evaluation of affective words using reaction time and event-related potential (ERP) measures. Eighteen younger subjects evaluated pleasantness of target words after seeing affective pictures as primes. The participants’ responses were faster and/or more accurate for valence-congruent trials than for incongruent trials, particularly with high-arousal stimuli. An ERP affective priming effect (N400) also occurred mainly in high-arousing stimulus pairs. In addition, whereas valence congruency influenced both the N400 and the LPP, arousal congruency influenced only the LPP, suggesting that arousal congruency mainly modulates post-semantic processes, but valence congruency effects begin with semantic processes. Overall, our current findings indicate that the arousal level of visual images impacts both behavioral and ERP effects of affective priming. Section Cognitive and Behavioral Neuroscience PMID:22820299

Field trial of a quantum secured 10 Gb/s DWDM transmission system over a single installed fiber.

PubMed

Choi, Iris; Zhou, Yu Rong; Dynes, James F; Yuan, Zhiliang; Klar, Andreas; Sharpe, Andrew; Plews, Alan; Lucamarini, Marco; Radig, Christian; Neubert, Jörg; Griesser, Helmut; Eiselt, Michael; Chunnilall, Christopher; Lepert, Guillaume; Sinclair, Alastair; Elbers, Jörg-Peter; Lord, Andrew; Shields, Andrew

2014-09-22

We present results from the first field-trial of a quantum-secured DWDM transmission system, in which quantum key distribution (QKD) is combined with 4 × 10 Gb/s encrypted data and transmitted simultaneously over 26 km of field installed fiber. QKD is used to frequently refresh the key for AES-256 encryption of the 10 Gb/s data traffic. Scalability to over 40 DWDM channels is analyzed.

Management of the potato cyst nematode (Globodera pallida) with bio-fumigants/stimulants.

PubMed

Martin, T J G; Turner, S J; Fleming, C C

2007-01-01

Field trials evaluated the effect of four plant-based bio-fumigants/stimulants on population levels of G. pallida and the resulting potato yields and quality. Three formulations contained seaweed biostimulants (Algifol, Nutridip and Metastim) and one bio-fumigant containing mustard and chilli pepper extracts (Dazitol). These were compared with the fumigant nematicide Nemathorin and untreated control plots. The effect of G. pallida on growing potato crops was assessed by recording haulm characteristics which indicated that the nematicide treatment gave most protection. Levels of PCN juveniles and migratory nematodes were assessed during the trial. Plots treated with Nemathorin and Dazitol had fewest PCN, whilst the highest number of migratory nematodes occurred in fallow plots. Sixteen weeks after planting the nematicide treatment produced highest yield and tuber numbers. Dazitol treatment produced a lower yield but the largest tubers.

Pharmacological interventions for pain in children and adolescents with life-limiting conditions.

PubMed

Beecham, Emma; Candy, Bridget; Howard, Richard; McCulloch, Renée; Laddie, Jo; Rees, Henrietta; Vickerstaff, Victoria; Bluebond-Langner, Myra; Jones, Louise

2015-03-13

Pain is one of the most common symptoms in children and young people (CYP) with life-limiting conditions (LLCs) which include a wide range of diagnoses including cancer. The current literature indicates that pain is not well managed, however the evidence base to guide clinicians is limited. There is a clear need for evidence from a systematic review to inform prescribing. To evaluate the evidence on the effectiveness of different pharmacological interventions used for pain in CYP with LLCs. The following electronic databases were searched up to December 2014: CENTRAL (in the Cochrane Library), MEDLINE, EMBASE, PsycINFO and CINAHL. In addition, we searched conference proceedings and reference lists of included studies. For completeness, we also contacted experts in the field. No language restrictions were applied. Randomised controlled trials (RCTs), quasi-randomised studies and other studies that included a clearly defined comparator group were included. The studies investigated pharmacological treatments for pain associated with LLCs in CYP. The treatment included those specifically developed to treat pain and those that acted as an adjuvant, where the treatment was not primarily developed to treat pain but has pain relieving properties. The LLC was identified by its inclusion in the Richard Hain Directory of LLCs. Citations were screened by five review authors. Data were extracted by one review author and checked by a second. Two review authors assessed the risk of bias of included studies. A sufficient number of studies using homogeneous outcomes was not identified so a meta-analysis was not possible. We identified 24,704 citations from our database search. Nine trials with 379 participants fulfilled our inclusion criteria. Participants had cerebral palsy (CP) in five of the studies and osteogenesis imperfecta (OI) in the other four. Participants across the trials ranged in age from 2 to 19 years. All studies, apart from one cross-over trial, were parallel designed RCTs. Three of the trials on CP evaluated intrathecal baclofen (ITB) and two botulinum toxin A (BoNT-A). All of the OI trials evaluated the use of bisphosphonates (two alendronate and one pamidronate). No trials were identified that evaluated a commonly used analgesic in this patient group. Pain was a secondary outcome in five of the eight identified studies. Overall the quality of the trials was mixed. Only one study involved over 100 participants.For the two ITB studies for pain in CP, in the same study population but assessed at different time points in their disease, both found an effect on pain favouring the intervention compared to the control group (standard care or placebo) (mean difference (MD) 4.20, 95% confidence interval (CI) 2.15 to 6.25; MD 26.60, 95% CI 2.61 to 50.59, respectively). In these studies most of the adverse events related to the procedure or device for administration rather than the drug, such as swelling at the pump site. In one trial there were also eight serious adverse effects; these included difficulty swallowing and an epileptic seizure. The trial did not state if these occurred in the intervention group. At follow-up in both BoNT-A trials there was no evidence of a difference in pain between the trial arms among CP participants. The adverse events in the BoNT-A trials mostly involved those who received the intervention drug and involved seizures. Gastrointestinal problems were the most frequent adverse event in those who received alendronate. The trial investigating pamidronate found no evidence of a difference in pain compared to the control group. No adverse events were reported in this trial. Published, controlled evidence on the pharmacological interventions for pain in CYP with LLCs is limited. The evidence that is currently available evaluated pain largely as a secondary outcome and the drugs used were all adjuvants and not always commonly used in general paediatric palliative care for pain. Based on current data this systematic review is unable to determine the effects of pharmacological interventions for pain for CYP with LLCs. Future trials with larger populations should examine the effects of the drugs commonly used as analgesics; with the rising prevalence of many LLCs this becomes more necessary.

Topical medication instillation techniques for glaucoma

PubMed Central

Xu, Li; Wang, Xuemei; Wu, Meijing

2017-01-01

Background Glaucoma is a leading cause of irreversible blindness worldwide and the second most common cause of blindness after cataracts. The primary treatment for glaucoma aims to lower intraocular pressure (IOP) with the use of topical medicines. Topical medication instillation techniques, such as eyelid closure and nasolacrimal occlusion when instilling drops, have been proposed as potential methods to increase ocular absorption and decrease systemic absorption of the drops. Objectives To investigate the effectiveness of topical medication instillation techniques compared with usual care or another method of instillation of topical medication in the management of glaucoma or ocular hypertension. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 12), MEDLINE Ovid (1946 to 8 December 2016), Embase Ovid (1947 to 8 December 2016), PubMed (1948 to 8 December 2016), LILACS (Latin American and Caribbean Health Sciences Literature Database) (1982 to 8 December 2016), International Pharmaceutical Abstracts Database (1970 to 8 December 2016), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com) (last searched 13 May 2013), ClinicalTrials.gov (www.clinicaltrials.gov) (searched 8 December 2016) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en) (searched 8 December 2016). We did not use any date or language restrictions in the electronic searches for trials. Selection criteria We included randomized controlled trials which had compared any topical medication instillation technique with usual care or a different method of instillation of topical medication. Data collection and analysis Two review authors independently screened records from the searches for eligibility, assessed the risk of bias, and extracted data. We followed methods recommended by Cochrane. Main results We identified two trials (122 eyes of 61 participants) that had evaluated a topical medication instillation technique. We also identified two ongoing trials. Both included trials used a within-person design and administered prostaglandin monotherapy for glaucoma or ocular hypertension. Because the trials evaluated different instillation techniques and assessed different outcomes, we performed no meta-analysis. One trial, conducted in the US, evaluated the effect of eyelid closure (one and three minutes) versus no eyelid closure on lowering IOP. At one to two weeks' follow-up, reduction in IOP was similar in the eyelid closure group and the no eyelid closure group (mean difference (MD) -0.33 mmHg, 95% confidence interval (CI) -0.8 to 1.5; 51 participants; moderate-certainty evidence). The second trial, conducted in Italy, evaluated the effect of using an absorbent cloth to wipe excess fluid after instillation (fluid removal) versus not using an absorbent cloth (no removal) on reducing dermatologic adverse events. At four months' follow-up, eyelashes were shorter among eyes in the fluid removal group compared with the no fluid removal group (MD -1.70 mm, 95% CI -3.46 to 0.06; 10 participants; low-certainty evidence). Fewer eyes showed skin hyperpigmentation in the eyelid region towards the nose in the fluid removal group compared with the no removal group (RR 0.07, 95% CI 0.01 to 0.84; 10 participants; low-certainty evidence); however, the difference was uncertain in the eyelid region towards the temples (RR 0.44, 95% CI 0.07 to 2.66; 10 participants; low-certainty evidence). The effect hypertrichosis (excessive hair growth) was uncertain between groups (RR 1.00, 95% CI 0.17 to 5.98; 10 participants; low-certainty evidence). Neither trial reported other outcomes specified for this review, including the proportion of participants with IOP less than 21 mmHg; participant-reported outcomes related to the ease, convenience, and comfort of instillation techniques; physiologic measurements of systemic absorption; escalation of therapy; mean change in visual fields; optic nerve progression; mean change in best-corrected visual acuity; proportion in whom glaucoma developed; quality of life outcomes; or cost-effectiveness outcomes. Neither trial reported data at follow-up times of more than four months. Authors' conclusions Evidence to evaluate the effectiveness of topical medication instillation techniques for treatment of glaucoma is lacking. It is unclear what, if any, effects instillation techniques have on topical medical therapy for glaucoma. PMID:28218404

Evaluation of a Blocked-Trials Procedure to Establish Complex Stimulus Control over Intraverbal Responses in Children with Autism

ERIC Educational Resources Information Center

Ingvarsson, Einar T.; Kramer, Rachel L.; Carp, Charlotte L.; Pétursdóttir, Anna I.; Macias, Heather

2016-01-01

We evaluated the use of a blocked-trials procedure to establish complex stimulus control over intraverbal responses. The participants were four young boys with a diagnosis of autism who had struggled to master intraverbals. The blocked-trials procedures involved presentation of stimuli in separate trial blocks. The trial blocks gradually reduced…

Evaluation of Visual Field and Imaging Outcomes for Glaucoma Clinical Trials (An American Ophthalomological Society Thesis).

PubMed

Garway-Heath, David F; Quartilho, Ana; Prah, Philip; Crabb, David P; Cheng, Qian; Zhu, Haogang

2017-08-01

To evaluate the ability of various visual field (VF) analysis methods to discriminate treatment groups in glaucoma clinical trials and establish the value of time-domain optical coherence tomography (TD OCT) imaging as an additional outcome. VFs and retinal nerve fibre layer thickness (RNFLT) measurements (acquired by TD OCT) from 373 glaucoma patients in the UK Glaucoma Treatment Study (UKGTS) at up to 11 scheduled visits over a 2 year interval formed the cohort to assess the sensitivity of progression analysis methods. Specificity was assessed in 78 glaucoma patients with up to 11 repeated VF and OCT RNFLT measurements over a 3 month interval. Growth curve models assessed the difference in VF and RNFLT rate of change between treatment groups. Incident progression was identified by 3 VF-based methods: Guided Progression Analysis (GPA), 'ANSWERS' and 'PoPLR', and one based on VFs and RNFLT: 'sANSWERS'. Sensitivity, specificity and discrimination between treatment groups were evaluated. The rate of VF change was significantly faster in the placebo, compared to active treatment, group (-0.29 vs +0.03 dB/year, P <.001); the rate of RNFLT change was not different (-1.7 vs -1.1 dB/year, P =.14). After 18 months and at 95% specificity, the sensitivity of ANSWERS and PoPLR was similar (35%); sANSWERS achieved a sensitivity of 70%. GPA, ANSWERS and PoPLR discriminated treatment groups with similar statistical significance; sANSWERS did not discriminate treatment groups. Although the VF progression-detection method including VF and RNFLT measurements is more sensitive, it does not improve discrimination between treatment arms.

Effects of Fumigant Nematicides on Yield and Quality of Paste Tomatoes Grown in Southwestern Ontario

PubMed Central

Reynolds, L. B.; Olthof, Th. H. A.; Potter, J. W.

1992-01-01

Field trials were conducted at the Delhi Research Station, Ontario, Canada, on a Fox loamy sand soil during 1987 and 1988 to evaluate the effects of row application of the fumigants Telone II, Telone C-17, Vorlex Plus, and Vorlex Plus CP on the yield and quality of paste tomato (Lycopersicon esculentum Mill. cv. Ferry Morse 6203). The four fumigants were equally effective in controlling the natural field populations of root lesion nematodes (Pratylenchus penetrans Cobb). A significant reduction in marketable red fruit yield due to different nematode densities at time of transplanting was observed in 1988. Fumigation did not significantly affect the yield of nonmarketable fruit, the relative maturation rate, or the processing quality in either year. PMID:19283042

Leveraging simulation to evaluate system performance in presence of fixed pattern noise

NASA Astrophysics Data System (ADS)

Teaney, Brian P.

2017-05-01

The development of image simulation techniques which map the effects of a notional, modeled sensor system onto an existing image can be used to evaluate the image quality of camera systems prior to the development of prototype systems. In addition, image simulation or `virtual prototyping' can be utilized to reduce the time and expense associated with conducting extensive field trials. In this paper we examine the development of a perception study designed to assess the performance of the NVESD imager performance metrics as a function of fixed pattern noise. This paper discusses the development of the model theory and the implementation and execution of the perception study. In addition, other applications of the image simulation component including the evaluation of limiting resolution and other test targets is provided.

Trial-by-trial adaptation of movements during mental practice under force field.

PubMed

Anwar, Muhammad Nabeel; Khan, Salman Hameed

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.

Spot drip application of dimethyl disulfide as a post-plant treatment for the control of plant parasitic nematodes and soilborne pathogens in grape production.

PubMed

Cabrera, J Alfonso; Wang, Dong; Gerik, James S; Gan, Jay

2014-07-01

Plant parasitic nematodes and soilborne pathogens can reduce the overall productivity in grape production. Not all grape growers apply soil fumigants before planting, and there is no single rootstock resistant to all nematode species. The aim of this investigation was to evaluate the effect of dimethyl disulfide (DMDS) applied at 112, 224, 448 and 897 kg ha(-1) as a post-plant treatment against soilborne plant parasitic nematodes and pathogens on the grape yield in established grapevines. In microplot and field trials, post-plant fumigation with DMDS controlled citrus (Tylenchulus semipenetrans), root-knot (Meloidogyne spp.), pin (Paratylenchus spp.) and ring (Mesocriconema xenoplax) nematodes in established Thomson Seedless grapevines. However, DMDS did not control the soilborne pathogens Pythium ultimum and Fusarium oxysporum. No indications of phytotoxicity were detected after post-plant fumigation with DMDS. In the field trial, grape yield was significantly higher with the lowest DMDS rate, but no difference among other rates was observed in comparison with the untreated control. Post-plant fumigation with DMDS controlled plant parasitic nematodes in established grapevines but was less efficacious against soilborne pathogens. Low rates of DMDS were sufficient for nematode control and increased the grape yield, probably without affecting beneficial soil organisms. Further research on evaluating the potential effect of DMDS against beneficial soil organisms is needed. Published 2013. This article is a U.S. Government work and is in the public domain in the USA.

The Impact of Three Commonly Used Fungicides on Typhlodromus pyri (Acari: Phytoseiidae) in European Vineyards.

PubMed

Kemmitt, G; Valverde-Garcia, P; Hufnagl, A; Bacci, L; Zotz, A

2015-04-01

The impact of the fungicides mancozeb, myclobutanil, and meptyldinocap on populations of Typhlodromus pyri Scheuten was evaluated under field conditions, when applied following the good agricultural practices recommended for their use. Two complementary statistical models were used to analyze the population reduction compared to the control: a linear mixed model to estimate the mean effect of the fungicide, and a generalized linear mixed model (proportional odds mixed model) to estimate the cumulative probability for those effects being equal or less than a specific IOBC class (International Organization for Biological and Integrated Control of Noxious Animal and Plants). Findings from 27 field experiments in a range of different vine-growing regions in Europe indicated that the use of mancozeb, myclobutanil, and meptyldinocap caused minimal impact on naturally occurring populations of T. pyri. Both statistical models confirmed that although adverse effects on T. pyri can occur under certain conditions after several applications of any of the three fungicides studied, the probability of the effects occurring is low and they will not persist. These methods demonstrated how data from a series of trials could be used to evaluate the variability of the effects caused by the chemical rather than relying on the worst-case findings from a single trial. © The Authors 2015. Published by Oxford University Press on behalf of Entomological Society of America. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

FSO and quality of service software prediction

NASA Astrophysics Data System (ADS)

Bouchet, O.; Marquis, T.; Chabane, M.; Alnaboulsi, M.; Sizun, H.

2005-08-01

Free-space optical (FSO) communication links constitute an alternative option to radio relay links and to optical cables facing growth needs in high-speed telecommunications (abundance of unregulated bandwidth, rapid installation, availability of low-cost optical components offering a high data rate, etc). Their operationalisation requires a good knowledge of the atmospheric effects which can negatively affect role propagation and the availability of the link, and thus to the quality of service (QoS). Better control of these phenomena will allow for the evaluation of system performance and thus assist with improving reliability. The aim of this paper is to compare the behavior of a FSO link located in south of France (Toulouse: with the following parameters: around 270 meters (0.2 mile) long, 34 Mbps data rate, 850 nm wavelength and PDH frame) with airport meteorological data. The second aim of the paper is to assess in-house FSO quality of service prediction software, through comparing simulations with the optical link data and the weather data. The analysis uses in-house software FSO quality of service prediction software ("FSO Prediction") developed by France Telecom Research & Development, which integrates news fog fading equations (compare to Kim & al.) and includes multiple effects (geometrical attenuation, atmospheric fading, rain, snow, scintillation and refraction attenuation due to atmospheric turbulence, optical mispointing attenuation). The FSO link field trial, intended to enable the demonstration and evaluation of these different effects, is described; and preliminary results of the field trial, from December 2004 to May 2005, are then presented.

In pursuit of a science of agriculture: the role of statistics in field experiments.

PubMed

Parolini, Giuditta

2015-09-01

Since the beginning of the twentieth century statistics has reshaped the experimental cultures of agricultural research taking part in the subtle dialectic between the epistemic and the material that is proper to experimental systems. This transformation has become especially relevant in field trials and the paper will examine the British agricultural institution, Rothamsted Experimental Station, where statistical methods nowadays popular in the planning and analysis of field experiments were developed in the 1920s. At Rothamsted statistics promoted randomisation over systematic arrangements, factorisation over one-question trials, and emphasised the importance of the experimental error in assessing field trials. These changes in methodology transformed also the material culture of agricultural science, and a new body, the Field Plots Committee, was created to manage the field research of the agricultural institution. Although successful, the vision of field experimentation proposed by the Rothamsted statisticians was not unproblematic. Experimental scientists closely linked to the farming community questioned it in favour of a field research that could be more easily understood by farmers. The clash between the two agendas reveals how the role attributed to statistics in field experimentation defined different pursuits of agricultural research, alternately conceived of as a scientists' science or as a farmers' science.

Field trials of a novel toolkit for evaluating 'intangible' values-related dimensions of projects.

PubMed

Burford, Gemma; Velasco, Ismael; Janoušková, Svatava; Zahradnik, Martin; Hak, Tomas; Podger, Dimity; Piggot, Georgia; Harder, Marie K

2013-02-01

A novel toolkit has been developed, using an original approach to develop its components, for the purpose of evaluating 'soft' outcomes and processes that have previously been generally considered 'intangible': those which are specifically values based. This represents a step-wise, significant, change in provision for the assessment of values-based achievements that are of absolutely key importance to most civil society organisations (CSOs) and values-based businesses, and fills a known gap in evaluation practice. In this paper, we demonstrate the significance and rigour of the toolkit by presenting an evaluation of it in three diverse scenarios where different CSOs use it to co-evaluate locally relevant outcomes and processes to obtain results which are both meaningful to them and potentially comparable across organisations. A key strength of the toolkit is its original use of a prior generated, peer-elicited 'menu' of values-based indicators which provides a framework for user CSOs to localise. Principles of participatory, process-based and utilisation-focused evaluation are embedded in this toolkit and shown to be critical to its success, achieving high face-validity and wide applicability. The emerging contribution of this next-generation evaluation tool to other fields, such as environmental values, development and environmental sustainable development, shared values, business, education and organisational change is outlined. Copyright © 2012 Elsevier Ltd. All rights reserved.

A randomized controlled trial on rehabilitation through caregiver-delivered nurse-organized service programs for disabled stroke patients in rural china (the RECOVER trial): design and rationale.

PubMed

Yan, Lijing L; Chen, Shu; Zhou, Bo; Zhang, Jing; Xie, Bin; Luo, Rong; Wang, Ninghua; Lindley, Richard; Zhang, Yuhong; Zhao, Yi; Li, Xian; Liu, Xiao; Peoples, Nicholas; Bettger, Janet Prvu; Anderson, Craig; Lamb, Sarah E; Wu, Yangfeng; Shi, Jingpu

2016-10-01

Stroke is the leading cause of death and disability in rural China. For stroke patients residing in resource-limited rural areas, secondary prevention and rehabilitation are largely unavailable, and where present, are far below evidence-based standards. This study aims to develop and implement a simplified stroke rehabilitation program that utilizes nurses and family caregivers for service delivery, and evaluate its feasibility and effectiveness in rural China. This 2-year randomized controlled trial is being conducted in 2-3 county hospitals located in northwest, northeast, and southwest China. Eligible and consenting stroke inpatients (200 in total) have been recruited and randomized into either a control or intervention group. Nurses in the county hospital are trained by rehabilitation specialists and in turn train the family caregivers in the intervention group. They also provide telephone follow-up care three times post discharge. The recruitment, baseline, intervention, follow-up care, and evaluation are guided by the RECOVER mobile phone app specifically designed for this study. The primary outcome is patients' Barthel Index (activities of daily living: mobility, self-care, and toileting) at 6 months. Process and economic evaluation will also be conducted. The results of our study will generate initial high-quality evidence to improve stroke care in resource-scarce settings. If proven effective, this innovative care delivery model has the potential to improve the health and function of stroke patients, relieve caregiver burden, guide policy-making, and advance translational research in the field of stroke care. © 2016 World Stroke Organization.

The STAMPEDE trial: paradigm-changing data through innovative trial design.

PubMed

Carthon, Bradley C; Antonarakis, Emmanuel S

2016-09-01

Despite the numerous regulatory approvals for prostate cancer, metastatic prostate cancer remains a huge burden for men worldwide. In an exciting development, James et al . recently published data from the Systemic Therapy in Advanced or Metastatic Prostate Cancer: Evaluation of Drug Efficacy: a multi-stage multi-arm randomised control trial (STAMPEDE). This is an innovative multi-arm multi-stage (MAMS) trial that has utilized one control arm and several comparator arms in order to provide evidence for the inclusion of therapies beyond standard androgen deprivation alone. The patient population included: (I) men with high-risk, non-metastatic, node-negative disease; (II) men with distant-metastatic or node-positive disease; and (III) men with previously-treated prostate cancer by prostatectomy or definitive radiotherapy presenting with relapse. Men were to continue androgen deprivation for at least 2 years. The current data published by this group supports earlier results and provides additional evidence that docetaxel utilized in an up-front fashion provides a survival benefit in men with hormone-sensitive metastatic prostate cancer. Moreover, the initial results from STAMPEDE show how therapies without a demonstrated survival benefit can be efficiently excluded from further study once the likelihood of a benefit is ruled out by a predetermined analysis. In this piece, we will review the STAMPEDE data, contrast it with existing results, and provide our perspectives on how this will affect future trial conduct in the field of prostate cancer.

Endophyte-enhanced phytoremediation of DDE-contaminated using Cucurbita pepo: A field trial.

PubMed

Eevers, N; Hawthorne, J R; White, J C; Vangronsveld, J; Weyens, N

2018-03-21

Although the use of the pesticide 2,2-bis(p-chlorophenyl)-1,1,1-trichloroethane (DDT) was banned from the mid-1970s, its most abundant and recalcitrant degradation product, 2,2-bis(p-chlorophenyl)-1,1-dichloro-ethylene (DDE), is still present in terrestrial and aquatic ecosystems worldwide. Zucchini (Cucurbita pepo ssp. pepo) has been shown to accumulate high concentrations of DDE and was proposed for phytoremediation of contaminated soils. We performed a field trial covering a full plant life cycle. C. pepo plants inoculated with the plant growth-promoting endophytic strains Sphingomonas taxi UH1, Methylobacterium radiotolerans UH1, Enterobacter aerogenes UH1, or a consortium combining these 3 strains were grown on a DDE-contaminated field for 100 days. The effects of these inoculations were examined at both the plant level, by evaluating plant weight and plant DDE-content, and at the level of the cultivable and total endophytic communities. Inoculating plants with S. taxi UH1, M. radiotolerans UH1, and the consortium increased plant weight. No significant effects of the inoculations were observed on DDE-concentrations in plant tissues. However, the amount of DDE accumulated by C. pepo plants per growing season was significantly higher for plants that were inoculated with the consortium of the 3 strains. Therefore, inoculation of C. pepo with DDE-degrading endophytes might be promising for phytoremediation applications.

Distribution and Downward Movement of Pasteuria penetrans in Field Soil.

PubMed

Cetintas, R; Dickson, D W

2005-06-01

Endospores of Pasteuria penetrans were evaluated for their vertical distribution in field soil and their downward movement through soil in the laboratory. In the field trial, the number of endospores attached to second-stage juveniles (J2) of Meloidogyne arenaria race 1 varied greatly in different soil depths. There were higher percentages of J2 with endospores attached in former weed fallow plots during the first 3 years of growing peanut than in former bahiagrass and rhizomal peanut plots (P 0.05). In laboratory trials, P. penetrans endospores were observed to move throughout the soil through the percolation of water. After one application of water, some endospores were detected 25 to 37.5 cm deep. Endospores were present at the greatest depth, 37.5 to 50 cm, after the third application of water. These results indicate that rain or water applications by irrigation are likely to move endospores to deeper levels of the soil, but the majority of endospores remain in the upper 0-to-30-cm depth.

Methods to Prove 20+ Year Life of CPV Products (in less than 20 Years)

NASA Astrophysics Data System (ADS)

Bowman, John; Spencer, Mark

2011-12-01

Due to the long term life expectations of photovoltaic products and the short duration of most introduced CPV technologies, it is critical for CPV companies to carefully construct field trials to prove product life. Because of the complicated geometric, thermal, and spectral characteristics of CPV systems, conducting very precise power output measurements reproducibly over many months is very difficult. Robust normalization methods specific to the exact optical system and PV cell type must be developed. Once the performance over a specific duration, e.g. one year, is established, then some justification is required to extrapolate to future performance. Comparisons to accelerated test results provide this justification. SolFocus has been conducting field trials of the SF-1100S CPV system for over two years. These field trials consist of controlled populations of SF-1100P modules, operating in grid-tied systems, which have been repeatedly measured at the individual module level over the duration of the trials. In this paper, field data will be presented along with normalization methodology and statistical methods for determining power degradation slope distributions for populations of individual modules. These results will be correlated with accelerated field tests which have been ongoing for 1.5 years and are estimated to be equivalent to 10 to 15 years of non-accelerated operation.

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…

Cucumber cultivars for container gardening and the value of field trials for predicting Cucumber performance in containers

USDA-ARS?s Scientific Manuscript database

Cucumber (Cucumis sativus L.) is one of the most popular vegetable crops grown in U.S. home and urban gardens. The objectives of this study were to identify cultivars and planting densities for high yield of container-grown cucumbers. Additional objectives were to determine the value of field trials...