Sample records for assessment study phase

  1. Assessment of Operational Automated Guideway Systems - Airtrans (Phase II)

    DOT National Transportation Integrated Search

    1980-01-01

    This study, Phase II, completes the assessment of AIRTRANS, the automated guideway system located at the Dallas-Fort Worth Airport. The Phase I assessment report: "Assessment of Operational Automated Guideway Systems--AIRTRANS (Phase I)" (PB-261 339)...

  2. Validation of the phase II feasibility study in a palliative care setting: gastrografin in malignant bowel obstruction.

    PubMed

    Lee, Cindy; Vather, Ryash; O'Callaghan, Anne; Robinson, Jackie; McLeod, Briar; Findlay, Michael; Bissett, Ian

    2013-12-01

    Malignant bowel obstruction (MBO) is common in patients with advanced cancer. To perform a phase II study to assess the feasibility of conducting a phase III trial investigating the therapeutic value of gastrografin in MBO. Randomized double-blinded placebo-controlled feasibility study. Participants received 100 mL of either gastrografin or placebo. Over 8 months, 57 patients were screened and 9 enrolled (15.8% recruitment rate). Of the 9 enrolled, 4 received gastrografin (with 2 completing assessment) and 5 received placebo (with 4 completing assessment). It is not feasible to conduct a phase III trial using the same study protocol. This study validates the use of the phase II feasibility study to assess protocol viability in a palliative population prior to embarking on a larger trial.

  3. Assessment of antibacterial and cytotoxic effects of orthodontic stainless steel brackets coated with different phases of titanium oxide: An in-vitro study.

    PubMed

    Baby, Roshen Daniel; Subramaniam, Siva; Arumugam, Ilakkiya; Padmanabhan, Sridevi

    2017-04-01

    Our objective was to assess the antibacterial and cytotoxic effects of orthodontic stainless steel brackets coated with different phases of photocatalytic titanium oxide. From a total sample of 115 brackets, 68 orthodontic stainless steel brackets were coated with titanium oxide using a radiofrequency magnetron sputtering machine. The coated brackets were then converted into 34 each of the anatase and rutile phases of titanium oxide. These brackets were subdivided into 4 groups for antibacterial study and 3 groups for cytotoxicity study. Brackets for the antibacterial study were assessed against the Streptococcus mutans species using microbiologic tests. Three groups for the cytotoxicity study were assessed using the thiazolyl tetrazolium bromide assay. The antibacterial study showed that both phases were effective, but the rutile phase of photocatalytic titanium oxide had a greater bactericidal effect than did the anatase phase. The cytotoxicity study showed that the rutile phase had a greater decrease in viability of cells compared with the anatase phase. It is recommended that orthodontic brackets be coated with the anatase phase of titanium oxide since they exhibited a significant antibacterial property and were only slightly cytotoxic. Copyright © 2016 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

  4. Patient-reported outcomes to assess the efficacy of extended-release guaifenesin for the treatment of acute respiratory tract infection symptoms.

    PubMed

    Albrecht, Helmut; Vernon, Margaret; Solomon, Gail

    2012-12-27

    Guaifenesin is a component of medicines used to improve symptoms associated with upper respiratory tract infections. Patient-reported outcome instruments are valuable for evaluating symptom improvements; however, a validated tool to assess efficacy of mucoactive drugs does not exist. We compared the efficacy of extended-release guaifenesin with placebo for treatment of symptoms of upper respiratory tract infection using subjective efficacy assessments in a pilot study and confirmed precision of assessments in a validation study. The pilot study was a randomized, double-blind study where patients were dosed with either 1200 mg extended-release guaifenesin (n = 188) or placebo (n = 190), every 12 hours for 7 days. Efficacy was assessed using subjective measures including the Daily Cough and Phlegm Diary, the Spontaneous Symptom Severity Assessment and the Wisconsin Upper Respiratory Symptom Survey. End-of-study assessments were completed by patients and investigator. The validation study consisted of two phases. In Phase I, subjects completed interviews to gather evidence to support the content validity of the Daily Cough and Phlegm Diary, the Spontaneous Symptom Severity Assessment and Patient's End-of-Treatment Assessment. Phase II examined the psychometric properties of assessments evaluated in Phase I of the validation study using data from the pilot study. Subjective measures of efficacy at Day 4 showed the most prominent difference between treatment groups, in favor of guaifenesin. The 8-symptom related questions (SUM8) in the Daily Cough and Phlegm Diary, analyzed as a composite score appeared to be the strongest candidate endpoint for further evaluation. Results from the interviews in Phase I supported the content of the assessments which were validated during Phase II. Treatments were well tolerated. Results from the clinical pilot and validation studies showed that the SUM8 diary scores were robust and reliable for use as efficacy endpoints in studies of mucoactive drugs. The study was registered with clinicaltrials.gov (NCT01046136).

  5. Patient-reported outcomes to assess the efficacy of extended-release guaifenesin for the treatment of acute respiratory tract infection symptoms

    PubMed Central

    2012-01-01

    Background Guaifenesin is a component of medicines used to improve symptoms associated with upper respiratory tract infections. Patient-reported outcome instruments are valuable for evaluating symptom improvements; however, a validated tool to assess efficacy of mucoactive drugs does not exist. We compared the efficacy of extended-release guaifenesin with placebo for treatment of symptoms of upper respiratory tract infection using subjective efficacy assessments in a pilot study and confirmed precision of assessments in a validation study. Methods The pilot study was a randomized, double-blind study where patients were dosed with either 1200 mg extended-release guaifenesin (n = 188) or placebo (n = 190), every 12 hours for 7 days. Efficacy was assessed using subjective measures including the Daily Cough and Phlegm Diary, the Spontaneous Symptom Severity Assessment and the Wisconsin Upper Respiratory Symptom Survey. End-of-study assessments were completed by patients and investigator. The validation study consisted of two phases. In Phase I, subjects completed interviews to gather evidence to support the content validity of the Daily Cough and Phlegm Diary, the Spontaneous Symptom Severity Assessment and Patient’s End-of-Treatment Assessment. Phase II examined the psychometric properties of assessments evaluated in Phase I of the validation study using data from the pilot study. Results Subjective measures of efficacy at Day 4 showed the most prominent difference between treatment groups, in favor of guaifenesin. The 8-symptom related questions (SUM8) in the Daily Cough and Phlegm Diary, analyzed as a composite score appeared to be the strongest candidate endpoint for further evaluation. Results from the interviews in Phase I supported the content of the assessments which were validated during Phase II. Treatments were well tolerated. Conclusions Results from the clinical pilot and validation studies showed that the SUM8 diary scores were robust and reliable for use as efficacy endpoints in studies of mucoactive drugs. Trial registration The study was registered with clinicaltrials.gov (NCT01046136). PMID:23270519

  6. Is objective and accurate cognitive assessment across the menstrual cycle possible? A feasibility study

    PubMed Central

    Neill, Jo; Scally, Andy; Tuffnell, Derek; Marshall, Kay

    2015-01-01

    Objectives: Variation in plasma hormone levels influences the neurobiology of brain regions involved in cognition and emotion processing. Fluctuations in hormone levels across the menstrual cycle could therefore alter cognitive performance and wellbeing; reports have provided conflicting results, however. The aim of this study was to assess whether objective assessment of cognitive performance and self-reported wellbeing during the follicular and luteal phases of the menstrual cycle is feasible and investigate the possible reasons for variation in effects previously reported. Methods: The Cambridge Neuropsychological Test Automated Battery and Edinburgh Postnatal Depression Scale were used to assess the cognitive performance and wellbeing of 12 women. Data were analysed by self-reported and hormone-estimated phases of the menstrual cycle. Results: Recruitment to the study and assessment of cognition and wellbeing was without issue. Plasma hormone and peptide estimation showed substantial individual variation and suggests inaccuracy in self-reported menstrual phase estimation. Conclusion: Objective assessment of cognitive performance and self-assessed wellbeing across the menstrual cycle is feasible. Grouping data by hormonal profile rather by self-reported phase estimation may influence phase-mediated results. Future studies should use plasma hormone and peptide profiles to estimate cycle phase and group data for analyses. PMID:26770760

  7. AN OVERVIEW OF THE NATIONAL HUMAN EXPOSURE ASSESSMENT SURVEY (NHEXAS) PHASE I STUDIES

    EPA Science Inventory

    The National Human Exposure Assessment Survey (NHEXAS) Phase I studies were sponsored by EPA's Office of Research and Development (ORD) to address critical information needs for assessing human exposures to multiple chemicals from multiple pathways and media. These studies were...

  8. Using a Multiple Intelligences Assessment To Facilitate Teacher Development.

    ERIC Educational Resources Information Center

    Shearer, C. Branton

    In phase 1 of this study, development and validation studies of a new assessment for the multiple intelligences were conducted. The second phase of the study was a pilot implementation project during a single academic year in collaboration with several public school teachers. Phase 1 involved a series of activities including initial instrument…

  9. A single dose of alcohol does not meaningfully alter circadian phase advances and phase delays to light in humans

    PubMed Central

    Rizvydeen, Muneer; Fogg, Louis F.; Keshavarzian, Ali

    2016-01-01

    Central circadian timing influences mental and physical health. Research in nocturnal rodents has demonstrated that when alcohol is consumed, it reaches the central hypothalamic circadian pacemaker (suprachiasmatic nuclei) and can directly alter circadian phase shifts to light. In two separate studies, we examined, for the first time, the effects of a single dose of alcohol on circadian phase advances and phase delays to light in humans. Two 23-day within-subjects placebo-controlled counterbalanced design studies were conducted. Both studies consisted of 6 days of fixed baseline sleep to stabilize circadian timing, a 2-day laboratory session, a 6-day break, and a repeat of 6 days of fixed sleep and a 2-day laboratory session. In the phase advance study (n = 10 light drinkers, 24–45 yr), the laboratory sessions consisted of a baseline dim light phase assessment, sleep episode, alcohol (0.6 g/kg) or placebo, 2-h morning bright light pulse, and final phase assessment. In the phase-delay study (n = 14 light drinkers, 22–44 yr), the laboratory sessions consisted of a baseline phase assessment, alcohol (0.8 g/kg) or placebo, 2-h late night bright light pulse, sleep episode, and final phase assessment. In both studies, alcohol either increased or decreased the observed phase shifts to light (interaction P ≥ 0.46), but the effect of alcohol vs. placebo on phase shifts to light was always on average smaller than 30 min. Thus, no meaningful effects of a single dose of alcohol vs. placebo on circadian phase shifts to light in humans were observed. PMID:26936778

  10. A single dose of alcohol does not meaningfully alter circadian phase advances and phase delays to light in humans.

    PubMed

    Burgess, Helen J; Rizvydeen, Muneer; Fogg, Louis F; Keshavarzian, Ali

    2016-04-15

    Central circadian timing influences mental and physical health. Research in nocturnal rodents has demonstrated that when alcohol is consumed, it reaches the central hypothalamic circadian pacemaker (suprachiasmatic nuclei) and can directly alter circadian phase shifts to light. In two separate studies, we examined, for the first time, the effects of a single dose of alcohol on circadian phase advances and phase delays to light in humans. Two 23-day within-subjects placebo-controlled counterbalanced design studies were conducted. Both studies consisted of 6 days of fixed baseline sleep to stabilize circadian timing, a 2-day laboratory session, a 6-day break, and a repeat of 6 days of fixed sleep and a 2-day laboratory session. In the phase advance study (n= 10 light drinkers, 24-45 yr), the laboratory sessions consisted of a baseline dim light phase assessment, sleep episode, alcohol (0.6 g/kg) or placebo, 2-h morning bright light pulse, and final phase assessment. In the phase-delay study (n= 14 light drinkers, 22-44 yr), the laboratory sessions consisted of a baseline phase assessment, alcohol (0.8 g/kg) or placebo, 2-h late night bright light pulse, sleep episode, and final phase assessment. In both studies, alcohol either increased or decreased the observed phase shifts to light (interaction P≥ 0.46), but the effect of alcohol vs. placebo on phase shifts to light was always on average smaller than 30 min. Thus, no meaningful effects of a single dose of alcohol vs. placebo on circadian phase shifts to light in humans were observed. Copyright © 2016 the American Physiological Society.

  11. Chesapeake Bay Low Freshwater Inflow Study. Phase II. MAP FOLIO. Biota Assessment.

    DTIC Science & Technology

    1982-05-01

    conditions. These were: 1) Base Average -- average freshwater inflow conditions. by increased water consumption projected for the year 2020. 3) Base Drought...RESOLUTION TEST CHART NATIONAL BUREAU OF STANDARDS. 1963- A TAI m - ii J May 1982 Chesapeake Bay Low Freshwater Inflow Study Phase II Biota Assessment Map...A PERIOD ZOVERED change was found to CIESAPEAKE BAY LOW FRESHWATER INFLOW STUDY FINAL BIOTA ASSESSMENT PHASE II: FINAL REPORT MAP FOLIO s PERFORMING

  12. Assessment Inventories, Surveys, and Templates for Evaluating Educational Technology Regional and Local Assistance Programs. Phase IV of the Comprehensive Study of Educational Technology Programs Authorized from 1984-1992.

    ERIC Educational Resources Information Center

    Far West Lab. for Educational Research and Development, San Francisco, CA.

    This report on Phase IV, of a four-phase study, provided for the development of evaluation templates and instruments to be used by the California Department of Education to facilitate systematic assessment of state funded educational technology programs and projects. These assessment documents comprised the major data collection sources for the…

  13. Assessing Hospital Disaster Readiness Over Time at the US Department of Veterans Affairs.

    PubMed

    Der-Martirosian, Claudia; Radcliff, Tiffany A; Gable, Alicia R; Riopelle, Deborah; Hagigi, Farhad A; Brewster, Pete; Dobalian, Aram

    2017-02-01

    Introduction There have been numerous initiatives by government and private organizations to help hospitals become better prepared for major disasters and public health emergencies. This study reports on efforts by the US Department of Veterans Affairs (VA), Veterans Health Administration, Office of Emergency Management's (OEM) Comprehensive Emergency Management Program (CEMP) to assess the readiness of VA Medical Centers (VAMCs) across the nation. Hypothesis/Problem This study conducts descriptive analyses of preparedness assessments of VAMCs and examines change in hospital readiness over time. To assess change, quantitative analyses of data from two phases of preparedness assessments (Phase I: 2008-2010; Phase II: 2011-2013) at 137 VAMCs were conducted using 61 unique capabilities assessed during the two phases. The initial five-point Likert-like scale used to rate each capability was collapsed into a dichotomous variable: "not-developed=0" versus "developed=1." To describe changes in preparedness over time, four new categories were created from the Phase I and Phase II dichotomous variables: (1) rated developed in both phases; (2) rated not-developed in Phase I but rated developed in Phase II; (3) rated not-developed in both phases; and (4) rated developed in Phase I but rated not- developed in Phase II. From a total of 61 unique emergency preparedness capabilities, 33 items achieved the desired outcome - they were rated either "developed in both phases" or "became developed" in Phase II for at least 80% of VAMCs. For 14 items, 70%-80% of VAMCs achieved the desired outcome. The remaining 14 items were identified as "low-performing" capabilities, defined as less than 70% of VAMCs achieved the desired outcome. Measuring emergency management capabilities is a necessary first step to improving those capabilities. Furthermore, assessing hospital readiness over time and creating robust hospital readiness assessment tools can help hospitals make informed decisions regarding allocation of resources to ensure patient safety, provide timely access to high-quality patient care, and identify best practices in emergency management during and after disasters. Moreover, with some minor modifications, this comprehensive, all-hazards-based, hospital preparedness assessment tool could be adapted for use beyond the VA. Der-Martirosian C , Radcliff TA , Gable AR , Riopelle D , Hagigi FA , Brewster P , Dobalian A . Assessing hospital disaster readiness over time at the US Department of Veterans Affairs. Prehsop Disaster Med. 2017;32(1):46-57.

  14. Post Hoc Analyses of the Effect of Crisaborole Topical Ointment, 2% on Atopic Dermatitis: Associated Pruritus from Phase 1 and 2 Clinical Studies.

    PubMed

    Draelos, Zoe Diana; Stein Gold, Linda F; Murrell, Dedee F; Hughes, Matilda H; Zane, Lee T

    2016-02-01

    Two post hoc analyses assessed the antipruritic activity of crisaborole topical ointment, 2% (crisaborole; Anacor Pharmaceuticals, Inc., Palo Alto, CA), a first-in-class boron-based phosphodiesterase-4 inhibitor in development for treatment of mild to moderate atopic dermatitis (AD). Two pooled analyses included data from 4 studies evaluating crisaborole in AD (study 1, phase 1b, systemic exposure, safety, and pharmacokinetics [PK] under maximal-use conditions in children and adolescents; study 2, phase 2a, safety and PK in adolescents; study 3, phase 2a, efficacy and safety in adults; study 4, phase 2, efficacy and safety in adolescents). Pooled data from studies 1 and 2 included whole body assessments; studies 3 and 4 included target lesion assessments. Pruritus severity was evaluated using a 4-point rating scale (0=none to 3=severe). Efficacy assessments included percent change from baseline in pruritus severity scores at days 8 (first pooled assessment), 15, 22, and 29 (whole body assessments) or days 15 (first pooled assessment), 22, and 29 (target lesions). Paired t-tests comparing change from baseline against zero were used to calculate P values. Categorical shifts in pruritus severity were also assessed (no to mild pruritus, 0-1.5; moderate to severe pruritus, 2-3). In the pooled analysis of studies 1 and 2 (N=57), the percent change from baseline in pruritus severity scores were 63.0% and 64.9% at days 8 and 29, respectively (P<0.001 for each). Similar results were observed in the pooled analysis of studies 3 and 4 (N=67). In both analyses, most patients had mild to no pruritus from the first time point assessed through the remainder of treatment. Treatment with crisaborole topical ointment, 2% resulted in statistically significant reductions in pruritus severity at the first time point evaluated in both analyses. These findings provide preliminary evidence of the antipruritic activity of crisaborole topical ointment, 2%.

  15. Tofacitinib, an oral Janus kinase inhibitor, in patients from Mexico with rheumatoid arthritis: Pooled efficacy and safety analyses from Phase 3 and LTE studies.

    PubMed

    Burgos-Vargas, Ruben; Cardiel, Mario; Xibillé, Daniel; Pacheco-Tena, César; Pascual-Ramos, Virginia; Abud-Mendoza, Carlos; Mahgoub, Ehab; Rahman, Mahboob; Fan, Haiyun; Rojo, Ricardo; García, Erika; Santana, Karina

    2017-05-25

    Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We characterized efficacy and safety of tofacitinib in Mexican patients from RA Phase 3 and long-term extension (LTE) studies. Data from Mexican patients with RA and an inadequate response to disease-modifying antirheumatic drugs (DMARDs) were taken from four Phase 3 studies (pooled across studies) and one open-label LTE study of tofacitinib. Patients received tofacitinib 5 or 10mg twice daily, adalimumab (one Phase 3 study) or placebo (four Phase 3 studies) as monotherapy or in combination with conventional synthetic DMARDs. Efficacy up to Month 12 (Phase 3) and Month 36 (LTE) was assessed by American College of Rheumatology 20/50/70 response rates, Disease Activity Score (erythrocyte sedimentation rate), and Health Assessment Questionnaire-Disability Index. Safety, including incidence rates (IRs; patients with events/100 patient-years) for adverse events (AEs) of special interest, was assessed throughout the studies. 119 and 212 Mexican patients were included in the Phase 3 and LTE analyses, respectively. Tofacitinib-treated patients in Phase 3 had numerically greater improvements in efficacy responses versus placebo at Month 3. Efficacy was sustained in Phase 3 and LTE studies. IRs for AEs of special interest were similar to those with tofacitinib in the global and Latin American RA populations. In Mexican patients from the tofacitinib global RA program, tofacitinib efficacy was demonstrated up to Month 12 in Phase 3 studies and Month 36 in the LTE study, with a safety profile consistent with tofacitinib global population. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.

  16. ROBIS: A new tool to assess risk of bias in systematic reviews was developed

    PubMed Central

    Whiting, Penny; Savović, Jelena; Higgins, Julian P.T.; Caldwell, Deborah M.; Reeves, Barnaby C.; Shea, Beverley; Davies, Philippa; Kleijnen, Jos; Churchill, Rachel

    2016-01-01

    Objective To develop ROBIS, a new tool for assessing the risk of bias in systematic reviews (rather than in primary studies). Study Design and Setting We used four-stage approach to develop ROBIS: define the scope, review the evidence base, hold a face-to-face meeting, and refine the tool through piloting. Results ROBIS is currently aimed at four broad categories of reviews mainly within health care settings: interventions, diagnosis, prognosis, and etiology. The target audience of ROBIS is primarily guideline developers, authors of overviews of systematic reviews (“reviews of reviews”), and review authors who might want to assess or avoid risk of bias in their reviews. The tool is completed in three phases: (1) assess relevance (optional), (2) identify concerns with the review process, and (3) judge risk of bias. Phase 2 covers four domains through which bias may be introduced into a systematic review: study eligibility criteria; identification and selection of studies; data collection and study appraisal; and synthesis and findings. Phase 3 assesses the overall risk of bias in the interpretation of review findings and whether this considered limitations identified in any of the phase 2 domains. Signaling questions are included to help judge concerns with the review process (phase 2) and the overall risk of bias in the review (phase 3); these questions flag aspects of review design related to the potential for bias and aim to help assessors judge risk of bias in the review process, results, and conclusions. Conclusions ROBIS is the first rigorously developed tool designed specifically to assess the risk of bias in systematic reviews. PMID:26092286

  17. Development of Autonomous Aerobraking (Phase 1)

    NASA Technical Reports Server (NTRS)

    Murri, Daniel G.; Powell, Richard W.; Prince, Jill L.

    2012-01-01

    The NASA Engineering and Safety Center received a request from Mr. Daniel Murri (NASA Technical Fellow for Flight Mechanics) to develop an autonomous aerobraking capability. An initial evaluation for all phases of this assessment was approved to proceed at the NESC Review Board meeting. The purpose of phase 1 of this study was to provide an assessment of the feasibility of autonomous aerobraking. During this phase, atmospheric, aerodynamic, and thermal models for a representative spacecraft were developed for both the onboard algorithm known as Autonomous Aerobraking Development Software, and a ground-based "truth" simulation developed for testing purposes. The results of the phase 1 assessment are included in this report.

  18. Assessing Risk/Benefit for Trials Using Preclinical Evidence: A Proposal

    PubMed Central

    Kimmelman, Jonathan; Henderson, Valerie C.

    2015-01-01

    Abstract Moral evaluation of risk/benefit in early phase studies requires assessing the clinical promise of a candidate intervention using preclinical evidence. Yet there is little to guide ethics committees, investigators, sponsors or other stakeholders morally charged with making these assessments (“evaluators”). In what follows, we draw on published guidelines for preclinical study design to develop a structured process for assessing the clinical promise of new interventions. In the first step, evaluators gather all relevant preclinical studies, assess the magnitude of treatment effects, and determine clinical promise in light of various threats to valid clinical inference. In the second step, evaluators adjust assessments of clinical promise from preclinical studies by examining how other agents in the same reference class-and supported by similar evidence- have fared in clinical development. Assessments of clinical promise can then be fed into moral evaluation of risk and benefit in early phase trials. Though our approach has limitations, it offers a systematic and transparent method for assessing risk/benefit in early phase trials of novel interventions. PMID:26463620

  19. CONTROLLED DIESEL EXPOSURES: INTER-PHASING HUMAN AND ANIMAL STUDIES AND THEIR USE IN THE RISK ASSESSMENT

    EPA Science Inventory

    Controlled diesel exposures: Inter-phasing human and animal studies and their use in the risk assessment process.
    Michael C. Madden, US EPA.

    Particulate matter (PM) has been reported to be associated with health effects (e.g., premature deaths, hospitalizations, lung ...

  20. A phased approach to clinical testing: criteria for progressing from Phase I to Phase II to Phase III studies.

    PubMed

    André, F E; Foulkes, M A

    1998-01-01

    The overall intent of clinical testing is to establish, in a series of phased studies, the clinical tolerance and acceptable "safety" of the candidate vaccine, as well as the type, level and persistence of the immune response after its inoculation, to a representative target population, according to a convenient administration schedule. The final stages involve the direct or indirect demonstration of protective efficacy, if possible in the population(s) for which the vaccine is intended. In addition, consistency of production must be demonstrated. At all these stages, the amount of prior information from preclinical and other studies affects and informs the objectives and design of subsequent studies. Progression from one testing phase to the next is dependent upon attaining the pre-set objectives of each series of studies. The precise objectives to be met will be decided on a case-by-case basis. The earliest assessments in humans (Phase I) involve evaluation of short-term clinical tolerance as measured by local and general reactogenicity, and gross assessments of immunogenicity, in a small number of highly selected individuals in an idealised situation. The selection of "optimal" dose and schedule are the result of further dose-ranging investigations (Phase II), involving more volunteers, with longer, more detailed follow-up assessments. It is at this stage that the accumulated evidence on its immunogenicity profile should be sufficient to assess whether or not the vaccine is worthy of further development. The next level of investigation (Phase III) aims to measure with greater precision the vaccine protective efficacy in the intended target population(s) by comparison of infection and/or disease attack rates in vaccine and placebo recipients. In consistency studies different production lots, manufactured at commercial scale, are tested to demonstrate consistency of manufacture. Additional bridging studies to establish similarity of lots at different production scales, or studies of the duration of the immunity conferred, are conducted in parallel with the progression of the studies in the different phases mentioned above. These latter types of studies are usually carried out concurrently with Phase III studies. This progression continues into the post-marketing period (Phase IV) with surveillance of long term efficacy and observational studies of possible rare adverse events to establish "safety" with more confidence. This paper examines, in general, the aims and designs of studies in each phase as an introduction to the more specific publications that follow.

  1. Independent University Study to Assess the Performance of a Humate Amendment for Copper Detoxification at the H-12 Outfall at Savannah River Site

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

    Looney, B.; Harmon, S.; King, J.

    2016-09-06

    The overarching objective of this study was to evaluate the effectiveness of the copper detoxification process that is in place at the Savannah River Site H-12 Outfall. The testing was performed in two phases; Phase 1 assessed the safety and potential for intrinsic toxicity of the humate amendment being used at the H-12 Outfall, Borregro HA-1, as well as an alternative amendment sodium humic acid. The second phase assessed the effectiveness of Borregro HA-1 in mitigating and reducing toxic effects of copper.

  2. Comprehensive assessment of long-term effects of reducing intake of energy phase 2 (CALERIE Phase 2) screening and recruitment: Methods and results

    USDA-ARS?s Scientific Manuscript database

    The Comprehensive Assessment of the Long-term Effects of Reducing Intake of Energy Phase 2 (CALERIE) study is a systematic investigation of sustained 25% calorie restriction (CR) in non-obese humans. CALERIE is a multicenter (3 clinical sites, one coordinating center), parallel group, randomized con...

  3. Safe routes to school (SRTS) statewide mobility assessment study : phase I report.

    DOT National Transportation Integrated Search

    2010-01-01

    This report presents the results of phase one of a two phase study designed to support state-level management of the Federal Highway Administration Safe Routes to School (SRTS) program. The study aims to achieve three objectives: (1) identify and use...

  4. Implementation of the Short-Term Assessment of Risk and Treatability over two phases.

    PubMed

    Kroppan, Erik; Nonstad, Kåre; Iversen, Runar Busch; Søndenaa, Erik

    2017-01-01

    Over the last decade, the Short-Term Assessment of Risk and Treatability (START) has provided a strong evidence base to predict a range of problem behaviors. The implementation of START and adaptation of the services to the use of START have so far been sparsely described in the literature. The purpose of this study was to describe the continuation and the interdisciplinarity of risk assessments through the two phases. Over a period of 10 years, the forensic mental health services at Brøset has implemented START in two phases: initially with implementing the instrument (2005-2009) and secondarily by customizing the instrument to everyday treatment and planning (since 2009). This implementation was based on data from 887 START assessments for 181 patients over a decade (2005-2015). The results showed that the number of START assessments has been stable throughout the past 10 years and the interval between the ratings has decreased significantly ( p <0.05). The involvement by diversity of professionals has increased significantly over the two implementation phases. This study also addressed the continuity and organization of the implementation process and presented an overview of how START has been widespread in the service through treatment. The results showed an increased multidisciplinary participation and a continuing rate of assessments as the implementation progressed from assessment to a combined assessment-treatment phase.

  5. Quality Measures in Pre-Analytical Phase of Tissue Processing: Understanding Its Value in Histopathology.

    PubMed

    Rao, Shalinee; Masilamani, Suresh; Sundaram, Sandhya; Duvuru, Prathiba; Swaminathan, Rajendiran

    2016-01-01

    Quality monitoring in histopathology unit is categorized into three phases, pre-analytical, analytical and post-analytical, to cover various steps in the entire test cycle. Review of literature on quality evaluation studies pertaining to histopathology revealed that earlier reports were mainly focused on analytical aspects with limited studies on assessment of pre-analytical phase. Pre-analytical phase encompasses several processing steps and handling of specimen/sample by multiple individuals, thus allowing enough scope for errors. Due to its critical nature and limited studies in the past to assess quality in pre-analytical phase, it deserves more attention. This study was undertaken to analyse and assess the quality parameters in pre-analytical phase in a histopathology laboratory. This was a retrospective study done on pre-analytical parameters in histopathology laboratory of a tertiary care centre on 18,626 tissue specimens received in 34 months. Registers and records were checked for efficiency and errors for pre-analytical quality variables: specimen identification, specimen in appropriate fixatives, lost specimens, daily internal quality control performance on staining, performance in inter-laboratory quality assessment program {External quality assurance program (EQAS)} and evaluation of internal non-conformities (NC) for other errors. The study revealed incorrect specimen labelling in 0.04%, 0.01% and 0.01% in 2007, 2008 and 2009 respectively. About 0.04%, 0.07% and 0.18% specimens were not sent in fixatives in 2007, 2008 and 2009 respectively. There was no incidence of specimen lost. A total of 113 non-conformities were identified out of which 92.9% belonged to the pre-analytical phase. The predominant NC (any deviation from normal standard which may generate an error and result in compromising with quality standards) identified was wrong labelling of slides. Performance in EQAS for pre-analytical phase was satisfactory in 6 of 9 cycles. A low incidence of errors in pre-analytical phase implies that a satisfactory level of quality standards was being practiced with still scope for improvement.

  6. ROBIS: A new tool to assess risk of bias in systematic reviews was developed.

    PubMed

    Whiting, Penny; Savović, Jelena; Higgins, Julian P T; Caldwell, Deborah M; Reeves, Barnaby C; Shea, Beverley; Davies, Philippa; Kleijnen, Jos; Churchill, Rachel

    2016-01-01

    To develop ROBIS, a new tool for assessing the risk of bias in systematic reviews (rather than in primary studies). We used four-stage approach to develop ROBIS: define the scope, review the evidence base, hold a face-to-face meeting, and refine the tool through piloting. ROBIS is currently aimed at four broad categories of reviews mainly within health care settings: interventions, diagnosis, prognosis, and etiology. The target audience of ROBIS is primarily guideline developers, authors of overviews of systematic reviews ("reviews of reviews"), and review authors who might want to assess or avoid risk of bias in their reviews. The tool is completed in three phases: (1) assess relevance (optional), (2) identify concerns with the review process, and (3) judge risk of bias. Phase 2 covers four domains through which bias may be introduced into a systematic review: study eligibility criteria; identification and selection of studies; data collection and study appraisal; and synthesis and findings. Phase 3 assesses the overall risk of bias in the interpretation of review findings and whether this considered limitations identified in any of the phase 2 domains. Signaling questions are included to help judge concerns with the review process (phase 2) and the overall risk of bias in the review (phase 3); these questions flag aspects of review design related to the potential for bias and aim to help assessors judge risk of bias in the review process, results, and conclusions. ROBIS is the first rigorously developed tool designed specifically to assess the risk of bias in systematic reviews. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  7. A multicenter study of topical azelaic acid 15% gel in combination with oral doxycycline as initial therapy and azelaic acid 15% gel as maintenance monotherapy.

    PubMed

    Thiboutot, Diane M; Fleischer, Alan B; Del Rosso, James Q; Rich, Phoebe

    2009-07-01

    This two-phase, multicenter study was undertaken to examine the safety and efficacy of combination therapy with oral doxycycline and topical azelaic acid (AzA) 15% gel in moderate-to-severe papulopustular rosacea and to determine the effect of subsequent maintenance monotherapy with AzA 15% gel alone. In the initial open-label, non-randomized phase of the study, subjects (n=172) received topical AzA 15% gel and oral doxycycline (100 mg), both twice daily, for < or = 12 weeks. In the second, double-blind study phase, subjects who had initially undergone at least four weeks of combination treatment in phase 1 and who achieved > or = 75% inflammatory lesion count reduction (n=136) were randomized to receive either AzA 15% gel or its vehicle twice daily for an additional 24 weeks. Assessments of efficacy were obtained at four-week intervals throughout both phases of the study and included change in inflammatory lesion count, investigator global assessment (IGA) of rosacea severity, and separate assessments of erythema and telangiectasia severity. At the last visit for each phase of the study, the investigator and participant each rated overall improvement, with the participant rating cosmetic acceptability and the investigator rating treatment as "success" or "failure" based on IGA score. During the second phase of the trial, the rate of relapse -- defined as either a 50% deterioration in the lesion count improvement from phase 1, an increase in erythema intolerable to the subject or maintenance therapy failure as judged by the investigator and/or the subject -- was obtained. Safety assessments were conducted for both phases of the study and included analysis of adverse events (AEs) and a rating of cutaneous tolerability by the subject. By week 12 of the open-label phase of the study, 81.4% of subjects had reached a 75% or greater reduction in inflammatory lesion count, and 64% of patients achieved treatment success. During the second study phase (maintenance phase), AzA 15% gel consistently provided a better maintenance response than vehicle, with maintenance of remission in 75% of patients over the six-month duration of the maintenance phase. Additionally AzA 15% gel showed a statistically significantly lower deterioration in absolute inflammatory lesion counts than did vehicle after 8, 16, 20 and 24 weeks of maintenance therapy. No serious treatment-related AEs were encountered in the study, and 98.5% of subjects were satisfied with the local tolerability of both AzA gel and vehicle.

  8. Status of the assessment phase of the ESA M3 mission candidate LOFT

    NASA Astrophysics Data System (ADS)

    Corral van Damme, Carlos; Ayre, Mark; Lumb, David; Short, Alexander D.; Rando, Nicola

    2012-09-01

    LOFT (Large Observatory For x-ray Timing) is one of four candidates for the M3 slot (launch in 2024, with the option of a launch in 2022) of ESAs Cosmic Vision 2015 - 2025 Plan, and as such it is currently undergoing an initial assessment phase lasting one year. The objective of the assessment phase is to provide the information required to enable the down selection process, in particular: the space segment definition for meeting the assigned science objectives; consideration of and initial definition of the implementation schedule; an estimate of the mission Cost at Completion (CaC); an evaluation of the technology readiness evaluation and risk assessment. The assessment phase is divided into two interleaved components: (i) A payload assessment study, performed by teams funded by member states, which is primarily intended for design, definition and programmatic/cost evaluation of the payload, and (ii) A system industrial study, which has essentially the same objectives for the space segment of the mission. This paper provides an overview of the status of the LOFT assessment phase, both for payload and platform. The initial focus is on the payload design status, providing the reader with an understanding of the main features of the design. Then the space segment assessment study status is presented, with an overview of the principal challenges presented by the LOFT payload and mission requirements, and a presentation of the expected solutions. Overall the mission is expected to enable cutting-edge science, is technically feasible, and should remain within the required CaC for an M3 candidate.

  9. Implementation of Performance Assessment in STEM (Science, Technology, Engineering, Mathematics) Education to Detect Science Process Skill

    NASA Astrophysics Data System (ADS)

    Septiani, A.; Rustaman, N. Y.

    2017-02-01

    A descriptive study about the implementation of performance assessment in STEM based instruction was carried out to investigate the tenth grade of Vocational school students’ science process skills during the teaching learning processes. A number of tenth grade agriculture students was involved as research subjects selected through cluster random sampling technique (n=35). Performance assessment was planned on skills during the teaching learning process through observation and on product resulted from their engineering practice design. The procedure conducted in this study included thinking phase (identifying problem and sharing idea), designing phase, construction phase, and evaluation phase. Data was collected through the use of science process skills (SPS) test, observation sheet on student activity, as well as tasks and rubrics for performance assessment during the instruction. Research findings show that the implementation of performance assessment in STEM education in planting media could detect students science process skills better from the observation individually compared through SPS test. It was also found that the result of performance assessment was diverse when it was correlated to each indicator of SPS (strong and positive; weak and positive).

  10. Psychopathological factors that can influence academic achievement in early adolescence: a three-year prospective study.

    PubMed

    Voltas, Núria; Hernández-Martínez, Carmen; Aparicio, Estefania; Arija, Victoria; Canals, Josefa

    2014-12-30

    This three-phase prospective study investigated psychosocial factors predicting or associated with academic achievement. An initial sample of 1,514 school-age children was assessed with screening tools for emotional problems (Screen for Childhood Anxiety and Related Emotional Disorders; Leyton Obsessional Inventory-Child Version; Children's Depression Inventory). The following year, 562 subjects (risk group/without risk group) were re-assessed and attention deficit/hyperactivity disorder (ADHD) was assessed. Two years later, 242 subjects were followed, and their parents informed about their academic achievement. Results showed that early depression (phase 1 B = -.130, p = .001; phase 1 + phase 2 B = -.187, p < .001), persistent anxiety symptoms (phase 1 + phase 2 B = -1.721, p = .018), and ADHD were predictors of lower academic achievement (phase 1 + phase 2 B = -3.415, p = .005). However, some anxiety symptoms can improve academic achievement (Social phobia B = .216, p = .018; Generalized anxiety B = .313, p < .001). Socio-economic status (SES) was positively related to academic achievement. We can conclude that in the transition period to adolescence, school-health professionals and teachers need to consider the emotional issues of students to avoid unwanted academic outcomes.

  11. A phase 1/2 dose-finding, safety, and activity study of cabazitaxel in pediatric patients with refractory solid tumors including tumors of the central nervous system.

    PubMed

    Manley, Peter E; Trippett, Tanya; Smith, Amy A; Macy, Margaret E; Leary, Sarah E S; Boklan, Jessica; Cohen, Kenneth J; Goldman, Stewart; Kilburn, Lindsay B; Dhall, Girish; Devin, Jeanne; Herzog, Cynthia E; Partap, Sonia; Fauchet, Floris; Badreddine, Emmy; Bernard, John P; Chi, Susan N

    2018-05-11

    This phase 1/2 study (NCT01751308) evaluated cabazitaxel in pediatric patients. Phase 1 determined the maximum tolerated dose (MTD) in patients with recurrent/refractory solid tumors, including central nervous system (CNS) tumors. Phase 2 evaluated activity in pediatric recurrent high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG). In phase 1, a 3 + 3 dose-escalation study design was followed. Cabazitaxel was administered at a starting dose of 20 mg/m 2 . Dose-limiting toxicities (DLTs) during cycle 1 were assessed to determine the MTD. Tumor response and cabazitaxel pharmacokinetics were also assessed. In phase 2, patients received cabazitaxel at the MTD determined in phase 1. Tumor responses were assessed every 9 weeks (modified Response Assessment in Neuro-oncology criteria). Progression-free survival and cabazitaxel pharmacokinetics were evaluated, and overall survival was estimated. In phase 1, 23 patients were treated, including 19 with CNS tumors. One patient had a partial response; five had stable disease for >3 cycles. Common adverse events included fatigue, diarrhea, nausea and vomiting, febrile neutropenia, and hypersensitivity reactions. Two of three DLTs (febrile neutropenia) occurred with a dose of 35 mg/m 2 ; the MTD was 30 mg/m 2 . Slightly higher cabazitaxel clearance was observed compared with adult trials. In phase 2, 16 patients (eight HGG and eight DIPG) were enrolled; 11 were evaluable for response and five withdrew (three due to anaphylaxis). All 11 patients progressed within four cycles. No responses were observed; the study was stopped due to futility. The safety profile of cabazitaxel was consistent with previous studies. The MTD (30 mg/m 2 ) was higher than the adult MTD. Cabazitaxel did not demonstrate activity in recurrent/refractory HGG or DIPG. © 2018 Wiley Periodicals, Inc.

  12. Transportation Life Cycle Assessment (LCA) Synthesis, Phase II

    DOT National Transportation Integrated Search

    2018-04-24

    The Transportation Life Cycle Assessment (LCA) Synthesis includes an LCA Learning Module Series, case studies, and analytics on the use of the modules. The module series is a set of narrated slideshows on topics related to environmental LCA. Phase I ...

  13. Implementation of the Short-Term Assessment of Risk and Treatability over two phases

    PubMed Central

    Kroppan, Erik; Nonstad, Kåre; Iversen, Runar Busch; Søndenaa, Erik

    2017-01-01

    Background Over the last decade, the Short-Term Assessment of Risk and Treatability (START) has provided a strong evidence base to predict a range of problem behaviors. The implementation of START and adaptation of the services to the use of START have so far been sparsely described in the literature. The purpose of this study was to describe the continuation and the interdisciplinarity of risk assessments through the two phases. Methods Over a period of 10 years, the forensic mental health services at Brøset has implemented START in two phases: initially with implementing the instrument (2005–2009) and secondarily by customizing the instrument to everyday treatment and planning (since 2009). This implementation was based on data from 887 START assessments for 181 patients over a decade (2005–2015). Results The results showed that the number of START assessments has been stable throughout the past 10 years and the interval between the ratings has decreased significantly (p<0.05). The involvement by diversity of professionals has increased significantly over the two implementation phases. Conclusion This study also addressed the continuity and organization of the implementation process and presented an overview of how START has been widespread in the service through treatment. The results showed an increased multidisciplinary participation and a continuing rate of assessments as the implementation progressed from assessment to a combined assessment–treatment phase. PMID:28860799

  14. Validation, Edits, and Application Processing System Report: Phase I.

    ERIC Educational Resources Information Center

    Gray, Susan; And Others

    Findings of phase 1 of a study of the 1979-1980 Basic Educational Opportunity Grants validation, edits, and application processing system are presented. The study was designed to: assess the impact of the validation effort and processing system edits on the correct award of Basic Grants; and assess the characteristics of students most likely to…

  15. Experiment evaluates ocean models and data assimiliation in the Gulf Stream

    NASA Astrophysics Data System (ADS)

    Willems, Robert C.; Glenn, S. M.; Crowley, M. F.; Malanotte-Rizzoli, P.; Young, R. E.; Ezer, T.; Mellor, G. L.; Arango, H. G.; Robinson, A. R.; Lai, C.-C. A.

    Using data sets of known quality as the basis for comparison, a recent experiment explored the Gulf Stream Region at 27°-47°N and 80°-50°W to assess the nowcast/forecast capability of specific ocean models and the impact of data assimilation. Scientists from five universities and the Naval Research Laboratory/Stennis Space Center participated in the Data Assimilation and Model Evaluation Experiment (DAMEÉ-GSR).DAMEÉ-GSR was based on case studies, each successively more complex, and was divided into three phases using case studies (data) from 1987 and 1988. Phase I evaluated models' forecast capability using common initial conditions and comparing model forecast fields with observational data at forecast time over a 2-week period. Phase II added data assimilation and assessed its impact on forecast capability, using the same case studies as in phase I, and phase III added a 2-month case study overlapping some periods in Phases I and II.

  16. Effect of Cystone® on urinary composition and stone formation over a one year period.

    PubMed

    Erickson, S B; Vrtiska, T J; Lieske, J C

    2011-07-15

    Kidney stones are a common problem for which inadequate prevention exists. We recruited ten recurrent kidney stone formers with documented calcium oxalate stones into a two phased study to assess safety and effectiveness of Cystone(®), an herbal treatment for prevention of kidney stones. The first phase was a randomized double-blinded 12 week cross over study assessing the effect of Cystone(®) vs. placebo on urinary supersaturation. The second phase was an open label one year study of Cystone(®) to determine if renal stone burden decreased, as assessed by quantitative and subjective assessment of CT. Results revealed no statistically significant effect of Cystone(®) on urinary composition short (6 weeks) or long (52 weeks) term. Average renal stone burden increased rather than decreased on Cystone(®). Therefore, this study does not support the efficacy of Cystone(®) to treat calcium oxalate stone formers. Future studies will be needed to assess effects on stone passage, or on other stone types. Copyright © 2011 Elsevier GmbH. All rights reserved.

  17. Dysphagia in Parkinson's disease.

    PubMed

    Hisashi, Shinobu; Fukumitsu, Ryoko; Ishida, Mitsuyo; Nodera, Atsuko; Otani, Takahiro; Maruoka, Takahiro; Nakamura, Kazumi; Izumi, Yuishin; Kaji, Ryuji; Nishida, Yoshihiko

    2016-08-31

    Although dysphagia is an important symptom associated with prognosis in patients with Parkinson's disease (PD), dysphagia tends to be overlooked until swallowing difficulties reach an advanced phase. We assessed dysphagia with videofluoroscopic examination of swallowing in 31 patients with mainly mild or moderate PD. Swallowing problems were observed in the pharyngeal phase in 28 patients, oral phase in 19 patients, esophageal phase in 15 patients, and oral preparatory phase in 1 patient. Therefore, dysphagia in the pharyngeal phase was observed in almost all patients with mild or moderate PD. In contrast, no dysfunction was detected in most patients when screening was conducted via questionnaire or other methods. Assessment of clinical parameters in the present study suggests that latent swallowing dysfunction may be present even in the early disease stage in PD. A future prospective study to follow swallowing functions in a pre-symptomatic phase in PD would be fruitful to find whether swallowing dysfunction is one of the prodromal symptoms.

  18. Does feedback matter? Practice-based learning for medical students after a multi-institutional clinical performance examination.

    PubMed

    Srinivasan, Malathi; Hauer, Karen E; Der-Martirosian, Claudia; Wilkes, Michael; Gesundheit, Neil

    2007-09-01

    Achieving competence in 'practice-based learning' implies that doctors can accurately self- assess their clinical skills to identify behaviours that need improvement. This study examines the impact of receiving feedback via performance benchmarks on medical students' self-assessment after a clinical performance examination (CPX). The authors developed a practice-based learning exercise at 3 institutions following a required 8-station CPX for medical students at the end of Year 3. Standardised patients (SPs) scored students after each station using checklists developed by experts. Students assessed their own performance immediately after the CPX (Phase 1). One month later, students watched their videotaped performance and reassessed (Phase 2). Some students received performance benchmarks (their scores, plus normative class data) before the video review. Pearson's correlations between self-ratings and SP ratings were calculated for overall performance and specific skill areas (history taking, physical examination, doctor-patient communication) for Phase 1 and Phase 2. The 2 correlations were then compared for each student group (i.e. those who received and those who did not receive feedback). A total of 280 students completed both study phases. Mean CPX scores ranged from 51% to 71% of items correct overall and for each skill area. Phase 1 self-assessment correlated weakly with SP ratings of student performance (r = 0.01-0.16). Without feedback, Phase 2 correlations remained weak (r = 0.13-0.18; n = 109). With feedback, Phase 2 correlations improved significantly (r = 0.26-0.47; n = 171). Low-performing students showed the greatest improvement after receiving feedback. The accuracy of student self-assessment was poor after a CPX, but improved significantly with performance feedback (scores and benchmarks). Videotape review alone (without feedback) did not improve self-assessment accuracy. Practice-based learning exercises that incorporate feedback to medical students hold promise to improve self-assessment skills.

  19. Total Energy Expenditure, Energy Intake, and Body Composition in Endurance Athletes Across the Training Season: A Systematic Review.

    PubMed

    Heydenreich, Juliane; Kayser, Bengt; Schutz, Yves; Melzer, Katarina

    2017-12-01

    Endurance athletes perform periodized training in order to prepare for main competitions and maximize performance. However, the coupling between alterations of total energy expenditure (TEE), energy intake, and body composition during different seasonal training phases is unclear. So far, no systematic review has assessed fluctuations in TEE, energy intake, and/or body composition in endurance athletes across the training season. The purpose of this study was to (1) systematically analyze TEE, energy intake, and body composition in highly trained athletes of various endurance disciplines and of both sexes and (2) analyze fluctuations in these parameters across the training season. An electronic database search was conducted on the SPORTDiscus and MEDLINE (January 1990-31 January 2015) databases using a combination of relevant keywords. Two independent reviewers identified potentially relevant studies. Where a consensus was not reached, a third reviewer was consulted. Original research articles that examined TEE, energy intake, and/or body composition in 18-40-year-old endurance athletes and reported the seasonal training phases of data assessment were included in the review. Articles were excluded if body composition was assessed by skinfold measurements, TEE was assessed by questionnaires, or data could not be split between the sexes. Two reviewers assessed the quality of studies independently. Data on subject characteristics, TEE, energy intake, and/or body composition were extracted from the included studies. Subjects were categorized according to their sex and endurance discipline and each study allocated a weight within categories based on the number of subjects assessed. Extracted data were used to calculate weighted means and standard deviations for parameters of TEE, energy intake, and/or body composition. From 3589 citations, 321 articles were identified as potentially relevant, with 82 meeting all of the inclusion criteria. TEE of endurance athletes was significantly higher during the competition phase than during the preparation phase (p < 0.001) and significantly higher than energy intake in both phases (p < 0.001). During the competition phase, both body mass and fat-free mass were significantly higher compared to other seasonal training phases (p < 0.05). Limitations of the present study included insufficient data being available for all seasonal training phases and thus low explanatory power of single parameters. Additionally, the classification of the different seasonal training phases has to be discussed. Male and female endurance athletes show important training seasonal fluctuations in TEE, energy intake, and body composition. Therefore, dietary intake recommendations should take into consideration other factors including the actual training load, TEE, and body composition goals of the athlete.

  20. Environmental impact assessment of a package type IFAS reactor during construction and operational phases: a life cycle approach.

    PubMed

    Singh, Nitin Kumar; Singh, Rana Pratap; Kazmi, Absar Ahmad

    2017-05-01

    In the present study, a life cycle assessment (LCA) approach was used to analyse the environmental impacts associated with the construction and operational phases of an integrated fixed-film activated sludge (IFAS) reactor treating municipal wastewater. This study was conducted within the boundaries of a research project that aimed to investigate the implementation related challenges of a package type IFAS reactor from an environmental perspective. Along with the LCA results of the construction phase, a comparison of the LCA results of seven operational phases is also presented in this study. The results showed that among all the inputs, the use of stainless steel in the construction phase caused the highest impact on environment, followed by electricity consumption in raw materials production. The impact of the construction phase on toxicity impact indicators was found to be significant compared to all operational phases. Among the seven operational phases of this study, the dissolved oxygen phase III, having a concentration of ∼4.5 mg/L, showed the highest impact on abiotic depletion, acidification, global warming, ozone layer depletion, human toxicity, fresh water eco-toxicity, marine aquatic eco-toxicity, terrestrial eco-toxicity, and photochemical oxidation. However, better effluent quality in this phase reduced the eutrophication load on environment.

  1. Factors associated with rape as predictors of laboratory aggression against women.

    PubMed

    Malamuth, N M

    1983-08-01

    This study examined the relation between factors associated with "real"-world aggression against women and laboratory aggression. In the first phase of the research, assessment was made of the attitudes about aggression against women and of the sexual responsiveness to rape of 42 male subjects. In the second phase of the research, which subjects believed was a totally independent experiment, aggression was assessed within a Buss paradigm. It was found that the factors assessed in the first phase successfully predicted men's laboratory aggression in the second research phase. The data are interpreted as supporting the construct validity of (a) theory that suggests that common factors underlie varied acts of aggression against women, (b) the measures designed to predict aggressive tendencies, and (c) the methodology of assessing aggression within a laboratory context.

  2. Development and psychometric evaluation of the Premarital Sexual Behavior Assessment Scale for Young Women (PSAS-YW): an exploratory mixed method study.

    PubMed

    Rahmani, Azam; Merghati-Khoei, Effat; Moghadam-Banaem, Lida; Hajizadeh, Ebrahim; Hamdieh, Mostafa; Montazeri, Ali

    2014-06-13

    Premarital sexual behaviors are important issue for women's health. The present study was designed to develop and examine the psychometric properties of a scale in order to identify young women who are at greater risk of premarital sexual behavior. This was an exploratory mixed method investigation. Indeed, the study was conducted in two phases. In the first phase, qualitative methods (focus group discussion and individual interview) were applied to generate items and develop the questionnaire. In the second phase, psychometric properties (validity and reliability) of the questionnaire were assessed. In the first phase an item pool containing 53 statements related to premarital sexual behavior was generated. In the second phase item reduction was applied and the final version of the questionnaire containing 26 items was developed. The psychometric properties of this final version were assessed and the results showed that the instrument has a good structure, and reliability. The results from exploratory factory analysis indicated a 5-factor solution for the instrument that jointly accounted for the 57.4% of variance observed. The Cronbach's alpha coefficient for the instrument was found to be 0.87. This study provided a valid and reliable scale to identify premarital sexual behavior in young women. Assessment of premarital sexual behavior might help to improve women's sexual abstinence.

  3. Development and psychometric evaluation of the Premarital Sexual Behavior Assessment Scale for Young Women (PSAS-YW): an exploratory mixed method study

    PubMed Central

    2014-01-01

    Background Premarital sexual behaviors are important issue for women’s health. The present study was designed to develop and examine the psychometric properties of a scale in order to identify young women who are at greater risk of premarital sexual behavior. Method This was an exploratory mixed method investigation. Indeed, the study was conducted in two phases. In the first phase, qualitative methods (focus group discussion and individual interview) were applied to generate items and develop the questionnaire. In the second phase, psychometric properties (validity and reliability) of the questionnaire were assessed. Results In the first phase an item pool containing 53 statements related to premarital sexual behavior was generated. In the second phase item reduction was applied and the final version of the questionnaire containing 26 items was developed. The psychometric properties of this final version were assessed and the results showed that the instrument has a good structure, and reliability. The results from exploratory factory analysis indicated a 5-factor solution for the instrument that jointly accounted for the 57.4% of variance observed. The Cronbach’s alpha coefficient for the instrument was found to be 0.87. Conclusion This study provided a valid and reliable scale to identify premarital sexual behavior in young women. Assessment of premarital sexual behavior might help to improve women’s sexual abstinence. PMID:24924696

  4. 4D phase contrast flow imaging for in-stent flow visualization and assessment of stent patency in peripheral vascular stents--a phantom study.

    PubMed

    Bunck, Alexander C; Jüttner, Alena; Kröger, Jan Robert; Burg, Matthias C; Kugel, Harald; Niederstadt, Thomas; Tiemann, Klaus; Schnackenburg, Bernhard; Crelier, Gerard R; Heindel, Walter; Maintz, David

    2012-09-01

    4D phase contrast flow imaging is increasingly used to study the hemodynamics in various vascular territories and pathologies. The aim of this study was to assess the feasibility and validity of MRI based 4D phase contrast flow imaging for the evaluation of in-stent blood flow in 17 commonly used peripheral stents. 17 different peripheral stents were implanted into a MR compatible flow phantom. In-stent visibility, maximal velocity and flow visualization were assessed and estimates of in-stent patency obtained from 4D phase contrast flow data sets were compared to a conventional 3D contrast-enhanced magnetic resonance angiography (CE-MRA) as well as 2D PC flow measurements. In all but 3 of the tested stents time-resolved 3D particle traces could be visualized inside the stent lumen. Quality of 4D flow visualization and CE-MRA images depended on stent type and stent orientation relative to the magnetic field. Compared to the visible lumen area determined by 3D CE-MRA, estimates of lumen patency derived from 4D flow measurements were significantly higher and less dependent on stent type. A higher number of stents could be assessed for in-stent patency by 4D phase contrast flow imaging (n=14) than by 2D phase contrast flow imaging (n=10). 4D phase contrast flow imaging in peripheral vascular stents is feasible and appears advantageous over conventional 3D contrast-enhanced MR angiography and 2D phase contrast flow imaging. It allows for in-stent flow visualization and flow quantification with varying quality depending on stent type. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  5. Assessment of a web-based Guided Self-Determination intervention for adults with type 2 diabetes in general practice: a study protocol

    PubMed Central

    Karlsen, Bjørg; Oftedal, Bjørg; Stangeland Lie, Silje; Rokne, Berit; Peyrot, Mark; Zoffmann, Vibeke; Graue, Marit

    2016-01-01

    Introduction Self-management is deemed the cornerstone in overall diabetes management. Web-based self-management interventions have potential to support adults with type 2 diabetes (T2DM) in managing their disease. Owing to somewhat ambiguous results of such interventions, interventions should be theory-based and incorporate well-defined counselling methods and techniques for behavioural change. This study is designed to assess the effectiveness of a theory-driven web-based Guided Self-Determination (GSD) intervention among adults with T2DM in general practice to improve diabetes self-management behaviours and glycosylated haemoglobin (HbA1c). Methods and analysis A complex intervention design based on the framework of the UK Medical Research Council is employed as a guide for developing the intervention, assessing its feasibility and evaluating its effectiveness. The study consists of three phases: (1) the modelling phase adapting the original GSD programme for adults with T2DM, using a qualitative design, (2) feasibility assessment of the adapted intervention on the web, employing qualitative and quantitative methods and (3) evaluating the effectiveness of the intervention on diabetes self-management behaviours and HbA1c, using a quasi-experimental design. The first phase, which is completed, and the second phase, which is underway, will provide important information about the development of the intervention and its acceptability, whereas the third phase will assess the effectiveness of this systematically developed intervention. Ethics and dissemination The Norwegian Regional Committee for Medical and Health Research Ethics (REK west number 2015/60) has approved the study design. Patients recruited in the different phases will fill out an informed consent form prior to inclusion and will be guaranteed anonymity and the right to withdraw from the study at any time. The results of the study will be published in peer-reviewed journals, electronically and in print, and presented at research conferences. Trial registration number: NCT02575599. PMID:27965253

  6. Adolescent Perspectives on Phase I Cancer Research

    PubMed Central

    Miller, Victoria A.; Baker, Justin N.; Leek, Angela C.; Hizlan, Sabahat; Rheingold, Susan R.; Yamokoski, Amy D.; Drotar, Dennis; Kodish, Eric

    2012-01-01

    Background The aim of this study was to examine adolescent patients’ perspectives on their understanding and decision making about a pediatric Phase I cancer study. Procedure Participants included adolescents ages 14-21 years with cancer (N = 20), all of whom attended a Phase I study consent conference. Participants responded to closed- and open-ended questions on a verbally administered structured interview, which assessed aspects of understanding and decision making about the Phase I study. Results All participants decided to enroll in the Phase I study. The majority of participants understood that participation was voluntary, entailed risks, and that they could withdraw. Most also believed that participation in the Phase I study would increase the length of their lives. The most frequent reasons for enrolling were positive clinical benefit, needing an option, impact on quality of life, and few side effects or fewer than those of current or past treatments. Eighty-five percent of participants reported that they themselves made the final decision about enrollment in the Phase I study. Conclusions Most participants hoped or expected that the Phase I study would provide a direct benefit (increased survival time or cure) and reported that they themselves were the final decision-maker about enrollment. Clinicians may underestimate the role of adolescents, especially if they believe that parents typically make such decisions. Future research should assess the actual participation of children and adolescents during the informed consent process and explore the role of hope in their decision making about Phase I studies. PMID:23034985

  7. Large-Scale Phase Synchrony Reflects Clinical Status After Stroke: An EEG Study.

    PubMed

    Kawano, Teiji; Hattori, Noriaki; Uno, Yutaka; Kitajo, Keiichi; Hatakenaka, Megumi; Yagura, Hajime; Fujimoto, Hiroaki; Yoshioka, Tomomi; Nagasako, Michiko; Otomune, Hironori; Miyai, Ichiro

    2017-06-01

    Stroke-induced focal brain lesions often exert remote effects via residual neural network activity. Electroencephalographic (EEG) techniques can assess neural network modifications after brain damage. Recently, EEG phase synchrony analyses have shown associations between the level of large-scale phase synchrony of brain activity and clinical symptoms; however, few reports have assessed such associations in stroke patients. The aim of this study was to investigate the clinical relevance of hemispheric phase synchrony in stroke patients by calculating its correlation with clinical status. This cross-sectional study included 19 patients with post-acute ischemic stroke admitted for inpatient rehabilitation. Interhemispheric phase synchrony indices (IH-PSIs) were computed in 2 frequency bands (alpha [α], and beta [β]), and associations between indices and scores of the Functional Independence Measure (FIM), the National Institutes of Health Stroke Scale (NIHSS), and the Fugl-Meyer Motor Assessment (FMA) were analyzed. For further assessments of IH-PSIs, ipsilesional intrahemispheric PSIs (IntraH-PSIs) as well as IH- and IntraH-phase lag indices (PLIs) were also evaluated. IH-PSIs correlated significantly with FIM scores and NIHSS scores. In contrast, IH-PSIs did not correlate with FMA scores. IntraH-PSIs correlate with FIM scores after removal of the outlier. The results of analysis with PLIs were consistent with IH-PSIs. The PSIs correlated with performance on the activities of daily living scale but not with scores on a pure motor impairment scale. These results suggest that large-scale phase synchrony represented by IH-PSIs provides a novel surrogate marker for clinical status after stroke.

  8. The Development of a Student Survey on Attitudes towards Mathematics Teaching-Learning Processes

    ERIC Educational Resources Information Center

    Mutohir, Toho Cholik; Lowrie, Tom; Patahuddin, Sitti Maesuri

    2018-01-01

    This study aimed to develop a survey instrument to measure student attitudes towards mathematics teaching-learning processes that is appropriate for the Indonesian context. This study consisted of two phases: Phase 1 (n = 320) was a pilot study to assess the suitability of the instrument items for Indonesian students. Phase 2 (n = 1001) was…

  9. Dental hygiene self-assessment: a key to quality care.

    PubMed

    DeVore, L; Fried, J L; Dailey, J; Qori, C G

    2000-01-01

    To help achieve the goal of delivering quality care to the public, this study applied the Theory of Reasoned Action to dental hygienists' self-assessment (appraisal of one's performance). This theory suggests that individuals are likely to exhibit a given behavior, i.e., self-assessment, when they view it positively and when they believe that important others think they should perform it. To date, no research has been conducted on the self-assessment (SA) behaviors of practicing dental hygienists. The following research questions were addressed: what/who are the (1) behavioral beliefs; (2) normative beliefs; (3) salient referents; (4) attitudes toward self-assessment; (5) intentions to perform self-assessment; (6) outcomes associated with self-assessment; and (7) motivations to comply with self-assessment in a representative sample of dental hygienists? This study consisted of two phases: Phase I, telephone interviews (N = 30) and Phase II, a mailed survey of 600 randomly selected subjects. Interview responses from Phase I determined questionnaire items. Survey data analysis included descriptive statistics and correlations of component mean scores. A total of 273 usable surveys were returned, achieving a 46% response rate. Respondents valued the potential benefits of SA with a statistical mean of 2.70 on a six point scale ranging from minus three to plus three. Attitude correlated strongly with intention to self-assess (R = .7455). Survey respondents are motivated by their own beliefs and perceived benefits of SA rather than by the values of others. The insights that were derived from this study will permit the development of strategies to enable dental hygiene educators and practitioners to incorporate self-assessment as part of quality assurance plans. Application of well-developed self-assessment strategies promises potential benefits for dental hygienists and the public they serve.

  10. Development of a methodology for strategic environmental assessment: application to the assessment of golf course installation policy in Taiwan.

    PubMed

    Chen, Ching-Ho; Wu, Ray-Shyan; Liu, Wei-Lin; Su, Wen-Ray; Chang, Yu-Min

    2009-01-01

    Some countries, including Taiwan, have adopted strategic environmental assessment (SEA) to assess and modify proposed policies, plans, and programs (PPPs) in the planning phase for pursuing sustainable development. However, there were only some sketchy steps focusing on policy assessment in the system of Taiwan. This study aims to develop a methodology for SEA in Taiwan to enhance the effectiveness associated with PPPs. The proposed methodology comprises an SEA procedure involving PPP management and assessment in various phases, a sustainable assessment framework, and an SEA management system. The SEA procedure is devised based on the theoretical considerations by systems thinking and the regulative requirements in Taiwan. The positive and negative impacts on ecology, society, and economy are simultaneously considered in the planning (including policy generation and evaluation), implementation, and control phases of the procedure. This study used the analytic hierarchy process, Delphi technique, and systems analysis to develop a sustainable assessment framework. An SEA management system was built based on geographic information system software to process spatial, attribute, and satellite image data during the assessment procedure. The proposed methodology was applied in the SEA of golf course installation policy in 2001 as a case study, which was the first SEA in Taiwan. Most of the 82 existing golf courses in 2001 were installed on slope lands and caused a serious ecological impact. Assessment results indicated that 15 future golf courses installed on marginal lands (including buffer zones, remedied lands, and wastelands) were acceptable because the comprehensive environmental (ecological, social, and economic) assessment value was better based on environmental characteristics and management regulations of Taiwan. The SEA procedure in the planning phase for this policy was completed but the implementation phase of this policy was not begun because the related legislation procedure could not be arranged due to a few senators' resistance. A self-review of the control phase was carried out in 2006 using this methodology. Installation permits for 12 courses on slope lands were terminated after 2001 and then 27 future courses could be installed on marginal lands. The assessment value of this policy using the data on ecological, social, and economic conditions from 2006 was higher than that using the data from 2001. The analytical results illustrate that the proposed methodology can be used to effectively and efficiently assist the related authorities for SEA.

  11. The appropriateness and feasibility of an online e-Portfolio for assessment of undergraduate allied health students.

    PubMed

    Cordier, Reinie; McAuliffe, Tomomi; Wilson, Nathan J; Totino, Rebekah; Dender, Alma; Smith, Cally; Stephens, Michaela

    2016-06-01

    Online technologies are widely used in tertiary institutions for both learning and assessment. There is a paucity of research into the use of e-Portfolios for assessment in the field of occupational therapy and other allied health disciplines. This study aimed to determine if a new assessment platform, using a flexible online learning platform, PebblePad(™) , is appropriate and feasible for use with allied health university staff and students in their first and second year of study. A mixed methods approach was employed in two phases, before the development of a new assessment (Phase 1) and after completion of the new assessment (Phase 2), aimed to generate a comprehensive analysis of the appropriateness and feasibility of the new assessment platform. Inductive thematic analysis was used to investigate participants' focus group responses in both phases. To assess learning outcomes survey responses were analysed using t-tests, and descriptive ratings of the assessment and current use of online platforms were extracted. Triangulated results indicate that the assessment did not meet all five domains of appropriateness. Negative experiences and a lack of social and ecological validity were attributed to the PebblePad(™) . The PebblePad(™) was not feasible, requiring extensive support in implementation. While PebblePad(™) did not meet all domains of appropriateness and was not feasible, students reported learning gains after completing the assessment, suggesting that content may be more important than the assessment platform. More rigorous research is needed to determine the best online platform for assessment in the allied health disciplines. © 2015 Occupational Therapy Australia.

  12. Performance assessment instrument to assess the senior high students' psychomotor for the salt hydrolysis material

    NASA Astrophysics Data System (ADS)

    Nahadi, Firman, Harry; Yulina, Erlis

    2016-02-01

    The purposes of this study were to develop a performance assessment instrument for assessing the competence of psychomotor high school students on salt hydrolysis concepts. The design used in this study was the Research & Development which consists of three phases: development, testing and application of instruments. Subjects in this study were high school students in class XI science, which amounts to 93 students. In the development phase, seven validators validated 17 tasks instrument. In the test phase, we divided 19 students into three-part different times to conduct performance test in salt hydrolysis lab work and observed by six raters. The first, the second, and the third groups recpectively consist of five, six, and eight students. In the application phase, two raters observed the performance of 74 students in the salt hydrolysis lab work in several times. The results showed that 16 of 17 tasks of performance assessment instrument developed can be stated to be valid with CVR value of 1,00 and 0,714. While, the rest was not valid with CVR value was 0.429, below the critical value (0.622). In the test phase, reliability value of instrument obtained were 0,951 for the five-student group, 0,806 for the six-student group and 0,743 for the eight-student group. From the interviews, teachers strongly agree with the performance instrument developed. They stated that the instrument was feasible to use for maximum number of students were six in a single observation.

  13. A Study of Attitudes Toward Child Abuse and Child Rearing Among Mexican American Migrants in Texas.

    ERIC Educational Resources Information Center

    Texas Migrant Council, Inc., Laredo.

    Divided into two phases, the study investigated the attitudes toward child abuse and neglect and child rearing practices held by Mexican American migrant farmworkers. The first phase involved a brief literature review and an assessment of the problem. During this phase also, the study's broad general goals were divided into 6 categories which led…

  14. NHEXAS PHASE I MARYLAND STUDY

    EPA Science Inventory

    The National Human Exposure Assessment Survey (NHEXAS) is a federal interagency research effort coordinated by the Environmental Protection Agency (EPA), Office of Research and Development (ORD). Phase I consists of demonstration/scoping studies using probability-based sampling ...

  15. Pilot study assessing differentiation of steatosis hepatis, hepatic iron overload, and combined disease using two-point dixon MRI at 3 T: in vitro and in vivo results of a 2D decomposition technique.

    PubMed

    Boll, Daniel T; Marin, Daniele; Redmon, Grace M; Zink, Stephen I; Merkle, Elmar M

    2010-04-01

    The purpose of our study was to evaluate whether two-point Dixon MRI using a 2D decomposition technique facilitates metabolite differentiation between lipids and iron in standardized in vitro liver phantoms with in vivo patient validation and allows semiquantitative in vitro assessment of metabolites associated with steatosis, iron overload, and combined disease. The acrylamide-based phantoms were made to reproduce the T1- and T2-weighted MRI appearances of physiologic hepatic parenchyma and hepatic steatosis-iron overload by the admixture of triglycerides and ferumoxides. Combined disease was simulated using joint admixtures of triglycerides and ferumoxides at various concentrations. For phantom validation, 30 patients were included, of whom 10 had steatosis, 10 had iron overload, and 10 had no liver disease. For MRI an in-phase/opposed-phase T1-weighted sequence with TR/TE(opposed-phase)/TE(in-phase) of 4.19/1.25/2.46 was used. Fat/water series were obtained by Dixon-based algorithms. In-phase and opposed-phase and fat/water ratios were calculated. Statistical cluster analysis assessed ratio pairs of physiologic liver, steatosis, iron overload, and combined disease in 2D metabolite discrimination plots. Statistical assessment proved that metabolite decomposition in phantoms simulating steatosis (1.77|0.22; in-phase/opposed-phase|fat/water ratios), iron overload (0.75|0.21), and healthy control subjects (1.09|0.05) formed three clusters with distinct ratio pairs. Patient validation for hepatic steatosis (3.29|0.51), iron overload (0.56|0.41), and normal control subjects (0.99|0.05) confirmed this clustering (p < 0.001). One-dimensional analysis assessing in vitro combined disease only with in-phase/opposed-phase ratios would have failed to characterize metabolites. The 2D analysis plotting in-phase/opposed-phase and fat/water ratios (2.16|0.59) provided accurate semiquantitative metabolite decomposition (p < 0.001). MR Dixon imaging facilitates metabolite decomposition of intrahepatic lipids and iron using in vitro phantoms with in vivo patient validation. The proposed decomposition technique identified distinct in-phase/opposed-phase and fat/water ratios for in vitro steatosis, iron overload, and combined disease.

  16. Assessing the Potential Environmental Consequences of a New Energetic Material: A Phased Approach

    DTIC Science & Technology

    2007-12-01

    Melting point • Ionization potential (2) QSAR approaches can also be used to estimate toxicological impact. Toxicity QSAR models can often... TOXICOLOGY STUDY NO. 87-XE-03N3-05 ASSESSING THE POTENTIAL ENVIRONMENTAL CONSEQUENCES OF A NEW ENERGETIC MATERIAL: A PHASED APPROACH...SEPTEMBER 2005 Published: December 2007 Approved for public release; distribution unlimited. Toxicology Study No. 87-XE-03N3-05

  17. Unified Multimodal Measurement for Performance Indication Research, Evaluation, and Effectiveness (UMMPIREE): Phase I Report

    DTIC Science & Technology

    2018-01-25

    generally a researcher into methods and techniques (i.e., the science) of assessment. This stakeholder may observe ongoing events/experiments or may use... Research Visualization Tool. A first step toward finding a method to link research . 3.1.2 Phase II: Linking and the Network Approach During Phase I, we...innovations. In the former realm, UMMPIREE will develop a method to link assessments from different research studies to guide research

  18. Phased array-fed antenna configuration study: Technology assessment

    NASA Technical Reports Server (NTRS)

    Croswell, W. F.; Ball, D. E.; Taylor, R. C.

    1983-01-01

    Spacecraft array fed reflector antenna systems were assessed for particular application to a multiple fixed spot beam/multiple scanning spot beam system. Reflector optics systems are reviewed in addition to an investigation of the feasibility of the use of monolithic microwave integrated circuit power amplifiers and phase shifters in each element of the array feed.

  19. Phase delaying the human circadian clock with a single light pulse and moderate delay of the sleep/dark episode: no influence of iris color.

    PubMed

    Canton, Jillian L; Smith, Mark R; Choi, Ho-Sun; Eastman, Charmane I

    2009-07-17

    Light exposure in the late evening and nighttime and a delay of the sleep/dark episode can phase delay the circadian clock. This study assessed the size of the phase delay produced by a single light pulse combined with a moderate delay of the sleep/dark episode for one day. Because iris color or race has been reported to influence light-induced melatonin suppression, and we have recently reported racial differences in free-running circadian period and circadian phase shifting in response to light pulses, we also tested for differences in the magnitude of the phase delay in subjects with blue and brown irises. Subjects (blue-eyed n = 7; brown eyed n = 6) maintained a regular sleep schedule for 1 week before coming to the laboratory for a baseline phase assessment, during which saliva was collected every 30 minutes to determine the time of the dim light melatonin onset (DLMO). Immediately following the baseline phase assessment, which ended 2 hours after baseline bedtime, subjects received a 2-hour bright light pulse (~4,000 lux). An 8-hour sleep episode followed the light pulse (i.e. was delayed 4 hours from baseline). A final phase assessment was conducted the subsequent night to determine the phase shift of the DLMO from the baseline to final phase assessment.Phase delays of the DLMO were compared in subjects with blue and brown irises. Iris color was also quantified from photographs using the three dimensions of red-green-blue color axes, as well as a lightness scale. These variables were correlated with phase shift of the DLMO, with the hypothesis that subjects with lighter irises would have larger phase delays. The average phase delay of the DLMO was -1.3 +/- 0.6 h, with a maximum delay of ~2 hours, and was similar for subjects with blue and brown irises. There were no significant correlations between any of the iris color variables and the magnitude of the phase delay. A single 2-hour bright light pulse combined with a moderate delay of the sleep/dark episode delayed the circadian clock an average of ~1.5 hours. There was no evidence that iris color influenced the magnitude of the phase shift. Future studies are needed to replicate our findings that iris color does not impact the magnitude of light-induced circadian phase shifts, and that the previously reported differences may be due to race.

  20. NHEXAS PHASE I ARIZONA STUDY

    EPA Science Inventory

    The National Human Exposure Assessment Survey (NHEXAS) is a federal interagency research effort coordinated by the Environmental Protection Agency (EPA), Office of Research and Development (ORD). The objective of the NHEXAS Phase I Arizona study was to determine the distribution...

  1. NHEXAS PHASE I REGION 5 STUDY

    EPA Science Inventory

    The National Human Exposure Assessment Survey (NHEXAS) is a federal interagency research effort coordinated by the Environmental Protection Agency (EPA), Office of Research and Development (ORD). Phase I consists of demonstration/scoping studies using probability-based sampling d...

  2. An assessment of differential reinforcement procedures for learners with autism spectrum disorder.

    PubMed

    Johnson, Kate A; Vladescu, Jason C; Kodak, Tiffany; Sidener, Tina M

    2017-04-01

    Differential reinforcement procedures may promote unprompted correct responding, resulting in a quicker transfer of stimulus control than nondifferential reinforcement. Recent studies that have compared reinforcement arrangements have found that the most effective arrangement may differ across participants. The current study conducted an assessment of differential reinforcement arrangements (i.e., quality, schedule, and magnitude) and nondifferential reinforcement to identify the most effective arrangement for each participant. The assessment phase showed that the quality arrangement was the most efficient for all participants during auditory-visual matching. Next, a validation phase was conducted to evaluate whether the assessment would predict the most effective arrangement across multiple skills. The results from the assessment phase were validated for all participants for the same skill. However, the results were only validated for one participant during the other skills (i.e., tact and intraverbal). The results are discussed in light of previous research and future areas of research. © 2017 Society for the Experimental Analysis of Behavior.

  3. Phased-array-fed antenna configuration study. Volume 1: Technology assessment

    NASA Technical Reports Server (NTRS)

    Sorbello, R. M.; Zaghloul, A. I.; Lee, B. S.; Siddiqi, S.; Geller, B. D.; Gerson, H. I.; Srinivas, D. N.

    1983-01-01

    The status of the technologies for phased-array-fed dual reflector systems is reviewed. The different aspects of these technologies, including optical performances, phased array systems, problems encountered in phased array design, beamforming networks, MMIC design and its incorporation into waveguide systems, reflector antenna structures, and reflector deployment mechanisms are addressed.

  4. A Longitudinal Assessment of Sleep Timing, Circadian Phase, and Phase Angle of Entrainment across Human Adolescence

    PubMed Central

    Crowley, Stephanie J.; Van Reen, Eliza; LeBourgeois, Monique K.; Acebo, Christine; Tarokh, Leila; Seifer, Ronald; Barker, David H.; Carskadon, Mary A.

    2014-01-01

    The aim of this descriptive analysis was to examine sleep timing, circadian phase, and phase angle of entrainment across adolescence in a longitudinal study design. Ninety-four adolescents participated; 38 (21 boys) were 9–10 years (“younger cohort”) and 56 (30 boys) were 15–16 years (“older cohort”) at the baseline assessment. Participants completed a baseline and then follow-up assessments approximately every six months for 2.5 years. At each assessment, participants wore a wrist actigraph for at least one week at home to measure self-selected sleep timing before salivary dim light melatonin onset (DLMO) phase – a marker of the circadian timing system – was measured in the laboratory. Weekday and weekend sleep onset and offset and weekend-weekday differences were derived from actigraphy. Phase angles were the time durations from DLMO to weekday sleep onset and offset times. Each cohort showed later sleep onset (weekend and weekday), later weekend sleep offset, and later DLMO with age. Weekday sleep offset shifted earlier with age in the younger cohort and later in the older cohort after age 17. Weekend-weekday sleep offset differences increased with age in the younger cohort and decreased in the older cohort after age 17. DLMO to sleep offset phase angle narrowed with age in the younger cohort and became broader in the older cohort. The older cohort had a wider sleep onset phase angle compared to the younger cohort; however, an age-related phase angle increase was seen in the younger cohort only. Individual differences were seen in these developmental trajectories. This descriptive study indicated that circadian phase and self-selected sleep delayed across adolescence, though school-day sleep offset advanced until no longer in high school, whereupon offset was later. Phase angle changes are described as an interaction of developmental changes in sleep regulation interacting with psychosocial factors (e.g., bedtime autonomy). PMID:25380248

  5. Wellness 101: Health Education for the University Student

    ERIC Educational Resources Information Center

    Higgins, S. Joan Wharf; Lauzon, Lara L.; Yew, Ann C.; Bratseth, Christopher D.; McLeod, Nicole

    2010-01-01

    Purpose: This paper aims to describe two phases of a mixed-method study: in phase I, the wellness practices of students at a Canadian university are reported. These data informed the re-development of a first-year health education course. Subsequent to its revision, phase II of the study assessed the impact of the course on students' wellness…

  6. Assessing Vocational Needs in a Female Correctional Institution.

    ERIC Educational Resources Information Center

    Koppel, Sheree P.

    A three-phase study was conducted at a female correctional institution in the Midwest to determine inmates' occupational aspirations and educational needs. In the first phase of the study, 121 of the 167 inmates participated in 9 forums in which they voiced their career choices and ranked them in priority order. In the second phase, a panel of…

  7. Maximizing Patient Recruitment and Retention in a Secondary Stroke Prevention Clinical Trial: Lessons Learned from the STAND FIRM Study.

    PubMed

    Thayabaranathan, Tharshanah; Cadilhac, Dominique A; Srikanth, Velandai K; Fitzgerald, Sharyn M; Evans, Roger G; Kim, Joosup; Gerraty, Richard P; Phan, Thanh G; Bladin, Christopher F; Nelson, Mark R; Frayne, Judith H; Thrift, Amanda G

    2016-06-01

    Recruitment and retention of patients in a clinical trial is important for generalizability and robustness of findings. We aimed to investigate features of a study design that were associated with recruitment and retention in a Phase II and Phase III trial of a secondary prevention program for stroke. Following informed consent in hospital, Phase II participants were randomized to intervention or usual care. Baseline clinical assessments were conducted at home approximately 3 months after discharge. In Phase III study, informed consent was obtained at home. We compared the characteristics of participants recruited and retained to 12 months for both phases. Interviews with study nurses were undertaken in order to ascertain their opinions of features of study design. Triangulation was used to identify the features of study design that nurses thought had improved recruitment and retention. All 24 eligible participants were recruited to the Phase II pilot study (100% recruitment), with 67% retention at 12 months. In Phase III study, 570 participants were recruited, and 93% of these participants had reached their 12-month assessment (n = 532) and were still participating. Consistent with the greater patient retention in Phase III study, nurses reported that patients' willingness to participate was greater when consent was obtained at home. Following a change in the consent process from hospital to home, more participants continued participation to 12 months. Pilot studies can provide important data to improve study design and better understand potential barriers to recruitment and retention. Copyright © 2016 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  8. Inadequate Preoperative Team Briefings Lead to More Intraoperative Adverse Events.

    PubMed

    Phadnis, Joideep; Templeton-Ward, Oliver

    2018-06-01

    Implementation of the World Health Organization checklists has reduced major surgical complications and errors; however, the impact of preoperative briefings on intraoperative adverse events has not been assessed. A prospective case-control study assessing the association between preoperative briefings and minor, potentially major, and major adverse intraoperative events was performed in 2 phases. Phase 1 involved prospective data collection for all trauma and orthopedic lists during a 2-week period. Changes were implemented as a result of the findings, and after this, the study was repeated (phase 2) to assess for the effect of the changes made to the practice. Forty-one lists were audited during phase 1 and 47 lists were audited during phase 2 of the study. Adequate preoperative briefings were performed in 10 (24%) of 41 lists in phase 1. There was a significant association between the occurrences of intraoperative adverse events (n = 37) when a briefing was not performed (P = < 0.01) and when a briefing was performed incompletely (P = 0.01). In phase 2, after staff reeducation and policy change, briefings were found to be adequate in 38 (81%) of 47 lists with the occurrence of only 3 adverse events. Team familiarity also improved significantly as a result of better preoperative briefings (P = 0.02). Inadequate preoperative briefings are associated with an increase in minor adverse events and are detrimental to team familiarity. On the basis of our findings, we recommend that all surgical units perform preoperative briefings thoroughly to minimize these factors.

  9. The Clock’N Test as a Possible Measure of Emotions: Normative Data Collected on a Non-clinical Population

    PubMed Central

    Gros, Auriane; Manera, Valeria; Daumas, Anaïs; Guillemin, Sophie; Rouaud, Olivier; Martin, Martine Lemesle; Giroud, Maurice; Béjot, Yannick

    2016-01-01

    Objective: At present emotional experience and implicit emotion regulation (IER) abilities are mainly assessed though self-reports, which are subjected to several biases. The aim of the present studies was to validate the Clock’N test, a recently developed time estimation task employing emotional priming to assess implicitly emotional reactivity and IER. Methods: In Study 1, the Clock’N test was administered to 150 healthy participants with different age, laterality and gender, in order to ascertain whether these factors affected the test results. In phase 1 participant were asked to judge the duration of seven sounds. In phase 2, before judging the duration of the same sounds, participants were presented with short arousing video-clip used as emotional priming stimuli. Time warp was calculated as the difference in time estimation between phase 2 and phase 1, and used to assess how emotions affected subjective time estimations. In study 2, a representative sample was selected to provide normative scores to be employed to assess emotional reactivity (Score 1) and IER (Score 2), and to calculate statistical cutoffs, based on the 10th and 90th score distribution percentiles. Results: Converging with previous findings, the results of study 1 suggested that the Clock’N test can be employed to assess both emotional reactivity, as indexed by an initial time underestimation, and IER, as indexed by a progressive shift to time overestimation. No effects of gender, age and laterality were found. Conclusions: These results suggest that the Clock’N test is adapted to assess emotional reactivity and IER. After collection of data on the test discriminant and convergent validity, this test may be employed to assess deficits in these abilities in different clinical populations. PMID:26903825

  10. Aerothermal modeling program, phase 2

    NASA Technical Reports Server (NTRS)

    Mongia, H. C.; Patankar, S. V.; Murthy, S. N. B.; Sullivan, J. P.; Samuelsen, G. S.

    1985-01-01

    The main objectives of the Aerothermal Modeling Program, Phase 2 are: to develop an improved numerical scheme for incorporation in a 3-D combustor flow model; to conduct a benchmark quality experiment to study the interaction of a primary jet with a confined swirling crossflow and to assess current and advanced turbulence and scalar transport models; and to conduct experimental evaluation of the air swirler interaction with fuel injectors, assessments of current two-phase models, and verification the improved spray evaporation/dispersion models.

  11. Changes in the Neuropsychological Correlates of Clinical Dimensions between the Acute and Stable Phase of Schizophrenia

    ERIC Educational Resources Information Center

    Guillem, F.; Ganeva, E.; Pampoulova, T.; Stip, E.; Lalonde, P.; Sasseville, M.

    2005-01-01

    This study was designed to investigate whether the neuropsychological correlates of the symptom dimensions of schizophrenia vary with the clinical state in patients followed from the acute to stable the phase of the illness. Fifteen patients were assessed for symptoms (SAPS-SANS) and undergone a complete neuropsychological assessment at two…

  12. The Role of the Replacement Behavior in Function-Based Intervention

    ERIC Educational Resources Information Center

    Reeves, Linda M.; Ferro, Jolenea B.; Umbreit, John; Liaupsin, Carl J.

    2017-01-01

    Three students with autism spectrum disorder (ASD) who displayed off-task behavior participated in a two-phase study. In Phase 1, a functional behavioral assessment (FBA) was conducted for each student. In addition, an assessment of each student's ability to perform the replacement behavior identified that none of the participants was able to do…

  13. In-Vitro Approaches for Studying Blast-Induced Traumatic Brain Injury

    PubMed Central

    Chen, Yung Chia; Smith, Douglas H.

    2009-01-01

    Abstract Traumatic brain injury caused by explosive or blast events is currently divided into four phases: primary, secondary, tertiary, and quaternary blast injury. These phases of blast-induced traumatic brain injury (bTBI) are biomechanically distinct, and can be modeled in both in-vivo and in-vitro systems. The purpose of this review is to consider the mechanical phases of bTBI, how these phases are reproduced with in-vitro models, and to review findings from these models to assess how each phase of bTBI can be examined in more detail. Highlighted are some important gaps in the literature that may be addressed in the future to better identify the exact contributing mechanisms for bTBI. These in-vitro models, viewed in combination with in-vivo models and clinical studies, can be used to assess both the mechanisms and possible treatments for this type of trauma. PMID:19397424

  14. Effect of formative evaluation using direct observation of procedural skills in assessment of postgraduate students of obstetrics and gynecology: Prospective study.

    PubMed

    Kumar, Naina; Singh, Namit Kant; Rudra, Samar; Pathak, Swanand

    2017-01-01

    Direct Observation of Procedural Skills (DOPS) is a way of evaluating procedural skills through observation in the workplace. The purpose of this study was to assess the role of DOPS in teaching and assessment of postgraduate students and to know the effect of repeated DOPS on improvement of the skills and confidence of the students. In both phases, significant difference was observed between the two groups on first DOPS comparison (1st phase: p=0.000; 2nd phase: p=0.002), with simulation group performing better. Comparison of sixth DOPS in the two groups revealed no difference in both phases, but significant difference on first and sixth DOPS comparison in each group (p=0.000). Repeated DOPS results in improved skills and confidence of students in managing real life obstetric emergencies irrespective of the teaching modality. Repeated DOPS results in improved skills and confidence of students in managing real life obstetric emergencies irrespective of the teaching modality.

  15. Effect of Air Pollution on Menstrual Cycle Length-A Prognostic Factor of Women's Reproductive Health.

    PubMed

    Merklinger-Gruchala, Anna; Jasienska, Grazyna; Kapiszewska, Maria

    2017-07-20

    Air pollution can influence women's reproductive health, specifically menstrual cycle characteristics, oocyte quality, and risk of miscarriage. The aim of the study was to assess whether air pollution can affect the length of the overall menstrual cycle and the length of its phases (follicular and luteal). Municipal ecological monitoring data was used to assess the air pollution exposure during the monitored menstrual cycle of each of 133 woman of reproductive age. Principal component analyses were used to group pollutants (PM 10 , SO₂, CO, and NO x ) to represent a source-related mixture. PM 10 and SO₂ assessed separately negatively affected the length of the luteal phase after standardization (b = -0.02; p = 0.03; b = -0.06; p = 0.02, respectively). Representing a fossil fuel combustion emission, they were also associated with luteal phase shortening (b = -0.32; p = 0.02). These pollutants did not affect the follicular phase length and overall cycle length, neither in single- nor in multi-pollutant models. CO and NO x assessed either separately or together as a traffic emission were not associated with overall cycle length or the length of cycle phases. Luteal phase shortening, a possible manifestation of luteal phase deficiency, can result from fossil fuel combustion. This suggests that air pollution may contribute to fertility problems in women.

  16. What Adherence Measures Should Be Used in Trials of Home-Based Rehabilitation Interventions? A Systematic Review of the Validity, Reliability, and Acceptability of Measures.

    PubMed

    Frost, Rachael; Levati, Sara; McClurg, Doreen; Brady, Marian; Williams, Brian

    2017-06-01

    To systematically review methods for measuring adherence used in home-based rehabilitation trials and to evaluate their validity, reliability, and acceptability. In phase 1 we searched the CENTRAL database, NHS Economic Evaluation Database, and Health Technology Assessment Database (January 2000 to April 2013) to identify adherence measures used in randomized controlled trials of allied health professional home-based rehabilitation interventions. In phase 2 we searched the databases of MEDLINE, Embase, CINAHL, Allied and Complementary Medicine Database, PsycINFO, CENTRAL, ProQuest Nursing and Allied Health, and Web of Science (inception to April 2015) for measurement property assessments for each measure. Studies assessing the validity, reliability, or acceptability of adherence measures. Two reviewers independently extracted data on participant and measure characteristics, measurement properties evaluated, evaluation methods, and outcome statistics and assessed study quality using the COnsensus-based Standards for the selection of health Measurement INstruments checklist. In phase 1 we included 8 adherence measures (56 trials). In phase 2, from the 222 measurement property assessments identified in 109 studies, 22 high-quality measurement property assessments were narratively synthesized. Low-quality studies were used as supporting data. StepWatch Activity Monitor validly and acceptably measured short-term step count adherence. The Problematic Experiences of Therapy Scale validly and reliably assessed adherence to vestibular rehabilitation exercises. Adherence diaries had moderately high validity and acceptability across limited populations. The Borg 6 to 20 scale, Bassett and Prapavessis scale, and Yamax CW series had insufficient validity. Low-quality evidence supported use of the Joint Protection Behaviour Assessment. Polar A1 series heart monitors were considered acceptable by 1 study. Current rehabilitation adherence measures are limited. Some possess promising validity and acceptability for certain parameters of adherence, situations, and populations and should be used in these situations. Rigorous evaluation of adherence measures in a broader range of populations is needed. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  17. Diagnosing paratonia in the demented elderly: reliability and validity of the Paratonia Assessment Instrument (PAI).

    PubMed

    Hobbelen, Johannes S M; Koopmans, Raymond T C M; Verhey, Frans R J; Habraken, Kitty M; de Bie, Rob A

    2008-08-01

    Paratonia is one of the associated movement disorders characteristic of dementia. The aim of this study was to develop an assessment tool (the Paratonia Assessment Instrument, PAI), based on the new consensus definition of paratonia. An additional aim was to investigate the reliability and validity of the PAI. A three-phase cross-sectional survey was conducted. In the first two phases, the PAI was developed and validated. In the third phase, the inter-observer reliability and feasibility of the instrument was tested. The original PAI consisted of five criteria that all needed to be met in order to make the diagnosis. On the basis of a qualitative analysis, one criterion was reformulated and another was removed. Following this, inter-observer reliability between the two assessors resulted in an improvement of Cohen's kappa from 0.532 in the initial phase to 0.677 in the second phase. This improvement was substantiated in the third phase by two independent assessors with Cohen's kappa ranging from 0.625 to 1. The PAI is a reliable and valid assessment tool for diagnosing paratonia in elderly people with dementia that can be applied easily in daily practice.

  18. Switching patients with erectile dysfunction from sildenafil citrate to tadalafil: results of a European multicenter, open-label study of patient preference.

    PubMed

    Ströberg, Peter; Murphy, Aileen; Costigan, Tim

    2003-11-01

    Three inhibitors of phosphodiesterase 5 (PDE5) are now available for the treatment of erectile dysfunction (ED): sildenafil citrate, vardenafil, and tadalafil. Pharmacologic differences between these compounds may result in patient preferences for one over another and may influence treatment decisions made by the physician and patient. Therefore, clinical research is needed to investigate whether individual properties of the PDE5 inhibitors play a role in shaping patient preference. The goal of this study was to determine what proportion of ED patients currently taking sildenafil would, after a period of treatment with tadalafil, elect to resume treatment with sildenafil at the customary dose and what proportion would elect a switch to tadalafil 20 mg for a longer period. The tolerability of both treatments was also investigated. This was a short-term, multicenter, open-label, 1-way crossover trial conducted in Sweden and Italy. Eligible patients included men aged >or=18 years with a minimum 3-month history of ED who had been taking sildenafil at stable fixed doses of 25, 50, or 100 mg as needed for at least 6 weeks and up to 24 weeks. The study consisted of 6 phases: a 1-week screening phase, a 3-week sildenafil assessment phase, a 1-week washout phase, a 6-week tadalafil initiation phase, a 3-week tadalafil assessment phase, and a 6-month extension phase, during which patients received their treatment of choice free of charge. The primary outcome measure was the proportion of patients electing to take sildenafil or tadalafil during the extension phase. Of 155 men enrolled, 147 (97.8%) completed the assessment phases of the trial. Of these 147 men, 133 (90.5%) elected to receive tadalafil in the 6-month extension phase and 14 (9.5%) elected to receive sildenafil (P < 0.001). The proportions preferring tadalafil to sildenafil were similar irrespective of age group (>or=50 years, 92%; <50 years, 90%), severity of ED (mild, 95%; moderate, 88%; severe, 96%), etiology of ED (psychogenic, 94%; organic, 91%; mixed, 87%), and sildenafil dose at study entry (50 mg, 90%; 100 mg, 89%). Both medications were well tolerated. The most common treatment-emergent adverse events occurring in >or=2% of patients during the tadalafil assessment phase included headache (4.8%), nasal congestion (4.1%), dyspepsia (3.4%), flushing (2.7%), back pain (2.0%), diarrhea (2.0%), and nausea (2.0%); the most common treatment-emergent adverse events during the sildenafil assessment phase were flusing (7.1%), nasal congestion (6.5%), headache (4.5%), and nasopharyngitis (3.2%). In this short-term, open-label study, patients who were currently taking sildenafil for ED and then received tadalafil preferred to continue oral therapy with tadalafil over sildenafil by a ratio of approximately 9:1. Although the study sought to mimic the experience of actual patients receiving treatment for ED, the results are subject to potential limitations due to the design of the study, which included differences in dosing instructions and dosages for sildenafil and tadalafil. Both sildenafil and tadalafil were well tolerated.

  19. Probabilistic risk assessment of the Space Shuttle. Phase 3: A study of the potential of losing the vehicle during nominal operation. Volume 5: Auxiliary shuttle risk analyses

    NASA Technical Reports Server (NTRS)

    Fragola, Joseph R.; Maggio, Gaspare; Frank, Michael V.; Gerez, Luis; Mcfadden, Richard H.; Collins, Erin P.; Ballesio, Jorge; Appignani, Peter L.; Karns, James J.

    1995-01-01

    Volume 5 is Appendix C, Auxiliary Shuttle Risk Analyses, and contains the following reports: Probabilistic Risk Assessment of Space Shuttle Phase 1 - Space Shuttle Catastrophic Failure Frequency Final Report; Risk Analysis Applied to the Space Shuttle Main Engine - Demonstration Project for the Main Combustion Chamber Risk Assessment; An Investigation of the Risk Implications of Space Shuttle Solid Rocket Booster Chamber Pressure Excursions; Safety of the Thermal Protection System of the Space Shuttle Orbiter - Quantitative Analysis and Organizational Factors; Space Shuttle Main Propulsion Pressurization System Probabilistic Risk Assessment, Final Report; and Space Shuttle Probabilistic Risk Assessment Proof-of-Concept Study - Auxiliary Power Unit and Hydraulic Power Unit Analysis Report.

  20. Consensus modeling to develop the farmers' market readiness assessment and decision instrument.

    PubMed

    Lee, Eunlye; Dalton, Jarrod; Ngendahimana, David; Bebo, Pat; Davis, Ashley; Remley, Daniel; Smathers, Carol; Freedman, Darcy A

    2017-09-01

    Nutrition-related policy, system, and environmental (PSE) interventions such as farmers' markets have been recommended as effective strategies for promoting healthy diet for chronic disease prevention. Tools are needed to assess community readiness and capacity factors influencing successful farmers' market implementation among diverse practitioners in different community contexts. We describe a multiphase consensus modeling approach used to develop a diagnostic tool for assessing readiness and capacity to implement farmers' market interventions among public health and community nutrition practitioners working with low-income populations in diverse contexts. Modeling methods included the following: phase 1, qualitative study with community stakeholders to explore facilitators and barriers influencing successful implementation of farmers' market interventions in low-income communities; phase 2, development of indicators based on operationalization of qualitative findings; phase 3, assessment of relevance and importance of indicators and themes through consensus conference with expert panel; phase 4, refinement of indicators based on consensus conference; and phase 5, pilot test of the assessment tool. Findings illuminate a range of implementation factors influencing farmers' market PSE interventions and offer guidance for tailoring intervention delivery based on levels of community, practitioner, and organizational readiness and capacity.

  1. Environmental assessment on electrokinetic remediation of multimetal-contaminated site: a case study.

    PubMed

    Kim, Do-Hyung; Yoo, Jong-Chan; Hwang, Bo-Ram; Yang, Jung-Seok; Baek, Kitae

    2014-05-01

    In this study, an environmental assessment on an electrokinetic (EK) system for the remediation of a multimetal-contaminated real site was conducted using a green and sustainable remediation (GSR) tool. The entire EK process was classified into major four phases consisting of remedial investigations (RIs), remedial action construction (RAC), remedial action operation (RAO), and long-term monitoring (LTM) for environmental assessment. The environmental footprints, including greenhouse gas (GHG) emissions, total energy used, air emissions of criteria pollutants, such as NOx, SOx, and PM10, and water consumption, were calculated, and the relative contribution in each phase was analyzed in the environmental assessment. In the RAC phase, the relative contribution of the GHG emissions, total energy used, and PM10 emissions were 77.3, 67.6, and 70.4%, respectively, which were higher than those of the other phases because the material consumption and equipment used for system construction were high. In the RAO phase, the relative contributions of water consumption and NOx and SOx emissions were 94.7, 85.2, and 91.0%, respectively, which were higher than those of the other phases, because the water and electricity consumption required for system operation was high. In the RIs and LTM phases, the environmental footprints were negligible because the material and energy consumption was less. In conclusion, the consumable materials and electrical energy consumption might be very important for GSR in the EK remediation process, because the production of consumable materials and electrical energy consumption highly affects the GHG emissions, total energy used, and air emissions such as NOx and SOx.

  2. Do lunar phases influence menstruation? A year-long retrospective study.

    PubMed

    Ilias, I; Spanoudi, F; Koukkou, E; Adamopoulos, D A; Nikopoulou, S C

    2013-07-01

    We assessed with cross-approximate entropy menstruation onset versus moon phases in 74 women with 980 menstrual cycles over a calendar year. In defiance of traditional beliefs and contrary to what some researchers have argued with short-term research work, in this long-term study we did not find any synchrony of lunar phases with the menstrual cycle.

  3. Structure of Enhanced Cued Recall Task in the 7 Minute Screen Test.

    PubMed

    Mora-Simon, Sara; Ladera-Fernandez, Valentina; Garcia-Garcia, Ricardo; Patino-Alonso, María C; Perea-Bartolome, M Victoria; Unzueta-Arce, Jaime; Perez-Arechaederra, Diana; Rodriguez-Sanchez, Emiliano

    2017-01-01

    Episodic memory in the 7 Minute Screen is assessed by the Enhanced Cued Recall (ECR) test. The ECR test is composed of three phases, Identification, Immediate Recall, and Free and Cued Recall. However, just the last phase is considered for the total score. We believe that collecting the performance data of the Identification and Immediate Recall phases could provide information regarding possible difficulties or impairments in the different aspects involved in the temporal mnesic process of acquisition of new information, such as in working memory or visual identification. The objective was to assess the goodness of fit for the three phases of the ECR test using a Confirmatory Factor Analysis (CFA) to show if each phase is separated from each other as a different aspect that participates in the mnesic process. A total of 311 participants greater than 65 years were included in this study. Confirmatory factor analyses were conducted for each individual phase. The analyses show that the ECR test consists of three separate phases that identify different steps of the mnesic process. Individual scores for each phase could allow for investigation of patient performance in different aspects of the memory process and could help in further neuropsychological assessment.

  4. Towards an operational definition of pharmacy clinical competency

    NASA Astrophysics Data System (ADS)

    Douglas, Charles Allen

    The scope of pharmacy practice and the training of future pharmacists have undergone a strategic shift over the last few decades. The pharmacy profession recognizes greater pharmacist involvement in patient care activities. Towards this strategic objective, pharmacy schools are training future pharmacists to meet these new clinical demands. Pharmacy students have clerkships called Advanced Pharmacy Practice Experiences (APPEs), and these clerkships account for 30% of the professional curriculum. APPEs provide the only opportunity for students to refine clinical skills under the guidance of an experienced pharmacist. Nationwide, schools of pharmacy need to evaluate whether students have successfully completed APPEs and are ready treat patients. Schools are left to their own devices to develop assessment programs that demonstrate to the public and regulatory agencies, students are clinically competent prior to graduation. There is no widely accepted method to evaluate whether these assessment programs actually discriminate between the competent and non-competent students. The central purpose of this study is to demonstrate a rigorous method to evaluate the validity and reliability of APPE assessment programs. The method introduced in this study is applicable to a wide variety of assessment programs. To illustrate this method, the study evaluated new performance criteria with a novel rating scale. The study had two main phases. In the first phase, a Delphi panel was created to bring together expert opinions. Pharmacy schools nominated exceptional preceptors to join a Delphi panel. Delphi is a method to achieve agreement of complex issues among experts. The principal researcher recruited preceptors representing a variety of practice settings and geographical regions. The Delphi panel evaluated and refined the new performance criteria. In the second phase, the study produced a novel set of video vignettes that portrayed student performances based on recommendations of an expert panel. Pharmacy preceptors assessed the performances with the new performance criteria. Estimates of reliability and accuracy from preceptors' assessments can be used to establish benchmarks for future comparisons. Findings from the first phase suggested preceptors held a unique perspective, where APPE assessments are based in relevance to clinical activities. The second phase analyzed assessment results from pharmacy preceptors who watched the video simulations. Reliability results were higher for non-randomized compared to randomized video simulations. Accuracy results showed preceptors more readily identified high and low student performances compared to average students. These results indicated the need for pharmacy preceptor training in performance assessment. The study illustrated a rigorous method to evaluate the validity and reliability of APPE assessment instruments.

  5. Feasibility study: Assess the feasibility of siting a monitored retrievable storage facility. Phase 1

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

    King, J.W.

    1993-08-01

    The purpose of phase one of this study are: To understand the waste management system and a monitored retrievable storage facility; and to determine whether the applicant has real interest in pursuing the feasibility assessment process. Contents of this report are: Generating electric power; facts about exposure to radiation; handling storage, and transportation techniques; description of a proposed monitored retrievable storage facility; and benefits to be received by host jurisdiction.

  6. A tutorial on pilot studies: the what, why and how

    PubMed Central

    2010-01-01

    Pilot studies for phase III trials - which are comparative randomized trials designed to provide preliminary evidence on the clinical efficacy of a drug or intervention - are routinely performed in many clinical areas. Also commonly know as "feasibility" or "vanguard" studies, they are designed to assess the safety of treatment or interventions; to assess recruitment potential; to assess the feasibility of international collaboration or coordination for multicentre trials; to increase clinical experience with the study medication or intervention for the phase III trials. They are the best way to assess feasibility of a large, expensive full-scale study, and in fact are an almost essential pre-requisite. Conducting a pilot prior to the main study can enhance the likelihood of success of the main study and potentially help to avoid doomed main studies. The objective of this paper is to provide a detailed examination of the key aspects of pilot studies for phase III trials including: 1) the general reasons for conducting a pilot study; 2) the relationships between pilot studies, proof-of-concept studies, and adaptive designs; 3) the challenges of and misconceptions about pilot studies; 4) the criteria for evaluating the success of a pilot study; 5) frequently asked questions about pilot studies; 7) some ethical aspects related to pilot studies; and 8) some suggestions on how to report the results of pilot investigations using the CONSORT format. PMID:20053272

  7. Study of the Application of Separation Control by Unsteady Excitation to Civil Transport Aircraft

    NASA Technical Reports Server (NTRS)

    McLean, J. D.; Crouch, J. D.; Stoner, R. C.; Sakurai, S.; Seidel, G. E.; Feifel, W. M.; Rush, H. M.

    1999-01-01

    This study provides a preliminary assessment of the potential benefits of applying unsteady separation control to transport aircraft. Estimates are given for some of the costs associated with a specific application to high-lift systems. High-leverage areas for future research were identified during the course of the study. The study was conducted in three phases. Phase 1 consisted of a coarse screening of potential applications within the aerodynamics discipline. Potential benefits were identified and in some cases quantified in a preliminary way. Phase 2 concentrated on the application to the wing high-lift system, deemed to have the greatest potential benefit for commercial transports. A team of experts, including other disciplines (i.e. hydraulic, mechanical, and electrical systems, structures, configurations, manufacturing, and finance), assessed the feasibility, benefits, and costs to arrive at estimates of net benefits. In both phases of the study, areas of concern and areas for future research were identified. In phase 3 of this study, the high-leverage areas for future research were prioritized as a guide for future efforts aimed at the application of active flow control to commercial transport aircraft.

  8. The Thinking-about-Derivative Test for Undergraduate Students: Development and Validation

    ERIC Educational Resources Information Center

    Aydin, Utkun; Ubuz, Behiye

    2015-01-01

    Two studies were conducted for the development and validation of a multidimensional test to assess undergraduate students' mathematical thinking about derivative. The first study involved two phases: question generation and refinement of the Thinking-about-Derivative Test (TDT). The second study included four phases as follows: test…

  9. Phase diagram calculations and high pressure Raman spectroscopy studies of organic "plastic crystal" thermal energy storage materials

    NASA Astrophysics Data System (ADS)

    Chellappa, Raja S.

    This dissertation presents the phase diagram calculations and high pressure Raman spectroscopy studies on organic "plastic crystal" thermal storage materials. The organic "plastic crystals" that were studied include pentaerythritol [PE:C(CH 2OH)4], neopentylglycol [NPG:(CH3)2C(CH 2OH)2], tris(hydroxymethyl)-aminomethane [TRIS:(NH2 )C(CH2OH)3], and 2-amino-2-methyl-1,3-propanediol [AMPL: (NH2)(CH3)C(CH2OH)2]. Thermodynamic optimization of the experimental data of AMPL-NPG and PE-AMPL binary system was performed and the calculated phase diagrams are presented. A preliminary calculated phase diagram of the TRIS-NPG binary system is also presented. A thorough reevaluation of the existing calorimetric and x-ray diffraction data of the PE-AMPL binary system is also presented. This analysis resulted in the correct interpretation of the phase boundaries and a revised phase diagram has been drawn. The results of high pressure Raman spectroscopy experiments on neopentylglycol and pentaerythritol presented. The phase transformation pressures were determined by analyzing the frequency shifts as a function of pressure as well as the changes in the internal modes of vibration for these compounds. A simplified assignment of the vibrational modes for NPG at ambient pressure is presented. The results indicate experiments were carried out using Diamond Anvil Cell (DAC) and the pressure induced transformations were studied by Raman spectroscopy. In NPG, a phase transition occurs at ˜3.6 GPa from Phase I (Monoclinic) to Phase II (unknown structure). In PE, the proposed phase transformation pressures are ˜4.8 GPa (Phase I to Phase II), ˜6.9 GPa (Phase II to Phase III), ˜9.5 GPa (Phase III to Phase IV), and ˜15 GPa (Phase IV to Amorphous). The results of a critical assessment of the vapor pressure data of solid metal carbonyls. The vapor pressure data of Chromium Carbonyl (Cr(CO)6), Tungsten Carbonyl (W(CO)6 ), Osmium Carbonyl (Os3(CO)12), Molybdenum Carbonyl (MO(CO)6). Rhenium Carbonyl (Re2(CO)10), and Manganese Carbonyl (Mn(CO)5) were assessed using the "Oonk Methodology". The sublimation properties using the assessed data (Delta subGo,DeltasubH o and Deltasub Cop,m ) of these compounds have been evaluated and a discussion on the mutual consistency of various data sets for each compound over a wide range of temperature is also presented.

  10. Impact of an intervention programme on knowledge, attitude and practice of healthcare staff regarding pharmaceutical waste management, Gaza, Palestine.

    PubMed

    Tabash, M I; Hussein, R A; Mahmoud, A H; El-Borgy, M D; Abu-Hamad, B A

    2016-09-01

    To assess knowledge, attitude and practice (KAP) of healthcare staff regarding pharmaceutical waste management; and to determine the impact of an educational programme on the KAP survey items. Pre-post-test intervention study. The pre-intervention phase was performed using a sample of 530 out of 1500 healthcare workers. A predesigned interview questionnaire was used to assess KAP. Next, an educational programme was designed and offered to a subsample of 69 healthcare workers. KAP were re-assessed for the programme attendees using the same interview questionnaire, both immediately (post-test) and six months after the end of the programme (follow-up test). The parametric paired sample t-test was used to assess the difference between pre-test and follow-up test results. Poor knowledge and poor practice levels (scores 50%) detected in the pre-intervention phase were found to improve to satisfactory levels (scores ≥75%) in the follow-up phase. Attitude was found to be positive (score ≥75%) in all phases of the study. The educational programme led to a significant improvement in KAP of healthcare staff regarding pharmaceutical waste management (P<0.001). Copyright © 2016. Published by Elsevier Ltd.

  11. Parental 'affectionless control' in adolescent depressive disorder.

    PubMed

    Patton, G C; Coffey, C; Posterino, M; Carlin, J B; Wolfe, R

    2001-10-01

    Adults with depressive disorder report high rates of sub-optimal maternal care in childhood. Despite the greater salience of relationships with parents earlier in life, associations with parenting style have not yet been systematically studied in adolescent onset disorder. A six-wave, 3-year study of adolescent health in 2032 Australian secondary school students provided an opportunity to undertake a two-phase study of early onset depression. Between waves 2 to 6, a self-administered computerised form of the revised Clinical Interview Schedule (CIS-R) was used to generate a first phase diagnosis of ICD-10 depressive episode. Each subject with a CIS-R-defined depressive episode was selected for second phase assessment together with two subjects from the CIS-R non-cases in each school. Second phase assessment included a second diagnostic assessment using the depression and hypomania modules of the Composite International Diagnostic Interview (CIDI) and assessment of paternal and maternal style using the Parental Bonding Instrument. A total of 1947 out of 2032 subjects in the sampling frame (95.8%) participated in the cohort study (phase 1) at least once; 406 (94%) of the 435 selected subjects completed second phase assessment. One hundred and nineteen subjects fulfilled criteria for depressive episode on the CIS-R at one or more waves. Over the 30-month study period, 69 subjects (10 male, 59 female) fulfilled both CIS-R and CIDI definitions of depression at the same wave and were classified as 'definite depressive disorder'. Low maternal and paternal care held independent associations with both definitions of depression, with the effects clearest in those in the lowest quartile of reported care. After adjusting for low parental care, the associations between high parental control and depression were small. Sub-optimal parenting is associated with depressive disorder in adolescents. Low maternal and paternal care are each associated with a two- to three-fold higher rate of depressive disorder. These findings are consistent with an effect of sub-optimal parenting on the onset rather than course of disorder. Whether sub-optimal parenting is associated with a risk for the onset of depression outside the adolescent years has yet to be clarified.

  12. Assessment model for the justification of intrusive lifestyle interventions: literature study, reasoning and empirical testing.

    PubMed

    Wesseling, Michiel; Wigersma, Lode; van der Wal, Gerrit

    2016-02-19

    In many countries health insurers, employers and especially governments are increasingly using pressure and coercion to enhance healthier lifestyles. For example by ever higher taxes on cigarettes and alcoholic beverages, and ever stricter smoke-free policies. Such interventions can enhance healthier behaviour, but when they become too intrusive, an unfree society can emerge. Which lifestyle interventions that use pressure or coercion are justifiable and which are not? We tried to develop an assessment model that can be used for answering this question, on a generally acceptable way, for all sorts of lifestyle interventions. The intended assessment model was developed in three phases. In the first phase the model was theoretically developed on the basis of literature study and reasoning. In the second phase the model was empirically tested by assessing two detailed cases from everyday practice using the model. The model was improved again and again. In the third phase (publication phase) the 10(th) version of the model was developed while writing this article. An assessment model for the justification of intrusive lifestyle interventions. It comprises three components: (1) 12 assessment criteria (necessity, causality, responsibility, appropriate design, effectiveness, intrusiveness, burdens-benefits-ratio, fairness, support, complementary policies, verifiability, implementation capacity); (2) an assessment structure with three filters (design logic, effects and side effects, implementation); (3) a way of assessing (based on reasonableness and transparency). We have developed an assessment model for the justification of lifestyle interventions that use pressure or coercion to promote health. The correctness, completeness and practicality of the model are likely. Important principles for the justification are the logic and completeness of the underlying argumentation and the proper use of the available scientific information. Parties for and against a particular intervention could use the model to test and strengthen their argumentation and to improve the quality of the intervention.

  13. Cognitive function in early clinical phase huntington disease after rivastigmine treatment.

    PubMed

    Sešok, Sanja; Bolle, Nika; Kobal, Jan; Bucik, Valentin; Vodušek, David B

    2014-09-01

    In Huntington disease (HD) patients receiving rivastigmine treatment improvement of behavioral symptoms and of cognitive function (assessed with screening diagnostic instruments) has been reported. The aim of the present study was to verify such improvement in cognitive function by cognitive function assessment with a detailed neuropsychological battery covering all relevant cognitive systems expected to be impaired in early phase HD. Eighteen (18) HD patients entered the study and were randomly allocated to the rivastigmine and placebo group. All subjects underwent neuropsychological assessment at baseline. Follow-up neuropsychological assessment was applied after 6 months of rivastigmine or placebo treatment. Eighteen (18) healthy controls entered the study to control for practice effect and underwent neuropsychological assessment at baseline and after 6 months, without treatment. The neuropsychological battery consisted of assessment tools that are sensitive to cognitive impairment seen in early phase HD: CTMT, SDMT, Stroop (attention and information control), RFFT, TOL, Verbal fluency (executive functioning), CVLT-II, RCFT (learning and memory). Effect of rivastigmine and possible effect of practice was assessed using the mixed ANOVA model. No statistically significant effect of rivastigmine treatment on cognitive function in HD patients was detected. There was no evidence for practice or placebo effect. Detailed neuropsychological assessment did not confirm previously reported effect of rivastigmine treatment on cognitive function in HD patients. The limitations of our study are, in particular, small sample size and the lack of a single measure of relevant cognitive functioning in HD patients. Instead of focusing solely on statistical significance, a clinical relevance study is proposed to clarify the issue of rivastigmine effects in HD.

  14. InternationaL cross-sectIonAl and longItudinal assessment on aSthma cONtrol in European adult patients - the LIAISON study protocol

    PubMed Central

    2013-01-01

    Background According to international guidelines, the goal of asthma management is to achieve and maintain control of the disease, which can be assessed using composite measures. Prospective studies are required to determine how these measures are associated with asthma outcomes and/or future risk. The ‘InternationaL cross-sectIonAl and longItudinal assessment on aSthma cONtrol (LIAISON)’ observational study has been designed to evaluate asthma control and its determinants, including components of asthma management. Methods/design The LIAISON study will be conducted in 12 European countries and comprises a cross-sectional phase and a 12-month prospective phase. Both phases will aim at assessing asthma control (six-item Asthma Control Questionnaire, ACQ), asthma-related quality of life (Mini Asthma Quality of Life Questionnaire, Mini-AQLQ), risk of non-adherence to treatment (four-item Morisky Medication Adherence Scale, MMAS-4), potential reasons for poor control, treatment strategies and associated healthcare costs. The cross-sectional phase will recruit > 8,000 adult patients diagnosed with asthma for at least 6 months and receiving the same asthma treatment in the 4 weeks before enrolment. The prospective phase will include all patients with uncontrolled/poorly controlled asthma at the initial visit to assess the proportion reaching control during follow-up and to examine predictors of future risk. Visits will take place after 3, 6 and 12 months. Discussion The LIAISON study will provide important information on the prevalence of asthma control and on the quality of life in a broad spectrum of real-life patient populations from different European countries and will also contribute to evaluate differences in management strategies and their impact on healthcare costs over 12 months of observation. Trial registration ClinicalTrials.gov identifier, NCT01567280. PMID:23530817

  15. Health technology assessment in Iran: challenges and views

    PubMed Central

    Olyaeemanesh, Alireza; Doaee, Shila; Mobinizadeh, Mohammadreza; Nedjati, Mina; Aboee, Parisa; Emami-Razavi, Seyed Hassan

    2014-01-01

    Background: Various decisions have been made on technology application at all levels of the health system in different countries around the world. Health technology assessment is considered as one of the best scientific tools at the service of policy- makers. This study attempts to investigate the current challenges of Iran’s health technology assessment and provide appropriate strategies to establish and institutionalize this program. Methods: This study was carried out in two independent phases. In the first, electronic databases such as Medline (via Pub Med) and Scientific Information Database (SID) were searched to provide a list of challenges of Iran’s health technology assessment. The views and opinions of the experts and practitioners on HTA challenges were studied through a questionnaire in the second phase which was then analyzed by SPSS Software version 16. This has been an observational and analytical study with a thematic analysis. Results: In the first phase, seven papers were retrieved; from which, twenty- two HTA challenges in Iran were extracted by the researchers; and they were used as the base for designing a structured questionnaire of the second phase. The views of the experts on the challenges of health technology assessment were categorized as follows: organizational culture, stewardship, stakeholders, health system management, infrastructures and external pressures which were mentioned in more than 60% of the cases and were also common in the views. Conclusion: The identification and prioritization of HTA challenges which were approved by those experts involved in the strategic planning of the Department of Health Technology Assessment will be a step forward in the promotion of an evidence- based policy- making and in the production of comprehensive scientific evidence. PMID:25695015

  16. 21 CFR 312.47 - Meetings.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Phase 3 plan and protocols and the adequacy of current studies and plans to assess pediatric safety and...) “End-of-Phase 2” meetings and meetings held before submission of a marketing application. At specific... and evaluation process. In particular, FDA has found that meetings at the end of Phase 2 of an...

  17. Relationship of pharmaceutical promotion to antidepressant switching and adherence: a retrospective cohort study.

    PubMed

    Hansen, Richard A; Chen, Shih-Yin; Gaynes, Bradley N; Maciejewski, Matthew L

    2010-12-01

    Patient nonadherence and early discontinuation of antidepressant treatment are common. Pharmaceutical promotion to consumers and physicians may influence this behavior. The objectives of this study were to explore whether promotional spending is related to early antidepressant switching, acute-phase adherence, and continuation-phase adherence. A retrospective cohort study was conducted with national promotional expenditure data merged with medical and prescription claims data from a large national health plan affiliated with i3 Innovus. Included were records for continuously insured adults with major depression who received a new prescription for an antidepressant: 5,010 were in the cohort assessed for switching, 4,457 were in the cohort assessed for acute-phase adherence, and 1,772 were in the cohort assessed for continuation-phase adherence. National promotional efforts were estimated by examining inflation-adjusted spending on direct-to-consumer advertising (DTCA) and physician detailing. Clinical guidelines were used to create proxies for aspects of treatment outcomes, including antidepressant switching and adherence in the acute phase and adherence in the continuation phase. Logistic regression models estimated the association between promotional variables and these outcomes. Patients taking medications that were more highly promoted to physicians were less likely to switch medications (odds ratio [OR]=.61) and were more likely to be adherent during the acute phase of treatment (OR=1.13). DTCA had little effect on switching or antidepressant adherence. Detailing to physicians was associated with lower rates of medication switching and had a positive relationship with patient adherence during early antidepressant treatment. This finding indicates that certain aspects of promotion may have beneficial effects on antidepressant use.

  18. Human responses to bright light of different durations.

    PubMed

    Chang, Anne-Marie; Santhi, Nayantara; St Hilaire, Melissa; Gronfier, Claude; Bradstreet, Dayna S; Duffy, Jeanne F; Lockley, Steven W; Kronauer, Richard E; Czeisler, Charles A

    2012-07-01

    Light exposure in the early night induces phase delays of the circadian rhythm in melatonin in humans. Previous studies have investigated the effect of timing, intensity, wavelength, history and pattern of light stimuli on the human circadian timing system. We present results from a study of the duration–response relationship to phase-delaying bright light. Thirty-nine young healthy participants (16 female; 22.18±3.62 years) completed a 9-day inpatient study. Following three baseline days, participants underwent an initial circadian phase assessment procedure in dim light (<3 lux), and were then randomized for exposure to a bright light pulse (∼10,000 lux) of 0.2 h, 1.0 h, 2.5 h or 4.0 h duration during a 4.5 h controlled-posture episode centred in a 16 h wake episode. After another 8 h sleep episode, participants completed a second circadian phase assessment. Phase shifts were calculated from the difference in the clock time of the dim light melatonin onset (DLMO) between the initial and final phase assessments. Exposure to varying durations of bright light reset the circadian pacemaker in a dose-dependent, non-linear manner. Per minute of exposure, the 0.2 h duration was over 5 times more effective at phase delaying the circadian pacemaker (1.07±0.36 h) as compared with the 4.0 h duration (2.65±0.24 h). Acute melatonin suppression and subjective sleepiness also had a dose-dependent response to light exposure duration. These results provide strong evidence for a non-linear resetting response of the human circadian pacemaker to light duration.

  19. Facilitating the implementation of the American College of Surgeons/Association of Program Directors in Surgery phase III skills curriculum: training faculty in the assessment of team skills.

    PubMed

    Hull, Louise; Arora, Sonal; Stefanidis, Dimitrios; Sevdalis, Nick

    2015-11-01

    Effective teamwork is critical to safety in the operating room; however, implementation of phase III of the American College of Surgeons (ACS) and Association of Program Directors in Surgery (APDS) Curriculum that focuses on team-based skills remains worryingly low. Training and assessing the complexities of teamwork is challenging. The objective of this study was to establish guidelines and recommendations for training faculty in assessing/debriefing team skills. A multistage survey-based consensus study was completed by 108 experts responsible for training and assessing surgical residents from the ACS Accredited Educational Institutes. Experts agreed that a program to teach faculty to assess team-based skills should include training in the recognition of teamwork skills, practice rating these skills, and training in the provision of feedback/debriefing. Agreement was reached that faculty responsible for conducting team-based skills assessment should be revalidated every 2 years and stringent proficiency criteria should be met. Faculty development is critical to ensure high-quality, standardized training and assessment. Training faculty to assess team-based skills has the potential to facilitate the effective implementation of phase III of the ACS and APDS Curriculum. Copyright © 2015 Elsevier Inc. All rights reserved.

  20. The impact of an educational DVD on cancer patients considering participation in a phase I clinical trial.

    PubMed

    Strevel, Elizabeth L; Newman, Colin; Pond, Gregory R; MacLean, Martha; Siu, Lillian L

    2007-07-01

    The quality of informed consent in phase I trials is controversial, partially due to gaps in patient understanding. We assessed an educational DVD's impact on knowledge and satisfaction in cancer patients newly referred to a phase I clinic. Forty-nine patients were randomly assigned to view an educational DVD (n = 22) which explained phase I trials or a placebo DVD (n = 27). Patients completed a questionnaire assessing knowledge of phase I studies and satisfaction with the DVD. The blinded interviewing physician (n = 8) rated the patient's understanding of phase I trials. The mean patient age was 56; 61% were male. Patients who viewed the educational DVD were less likely to believe that phase I trials determine drug efficacy (p = 0.019), more likely to know that phase I drugs have not been thoroughly studied in humans (p = 0.003), and less likely to believe that these agents have proven activity against human cancers (p = 0.008). More patients who viewed the educational DVD agreed/strongly agreed that the DVD provided useful information (p < 0.001), were confident in their knowledge of phase I trials (p = 0.031), felt aided in their decision to enter a phase I study (p = 0.011), and would have more questions for their physicians because of the DVD (p = 0.017). No statistically significant difference in physician perception of patient understanding or phase I trial accrual was observed between the educational and placebo DVD groups. An educational DVD increased patient knowledge and satisfaction regarding participation in phase I clinical trials.

  1. Addendum to validation of FHWA's Traffic Noise Model (TNM) : phase 1

    DOT National Transportation Integrated Search

    2004-07-01

    (FHWA) is conducting a multiple-phase study to assess the accuracy and make recommendations on the use of FHWAs Traffic Noise Model (TNM). The TNM Validation Study involves highway noise data collection and TNM modeling for the purpose of data com...

  2. Phase-contrast cerebrospinal fluid flow magnetic resonance imaging in qualitative evaluation of patency of CSF flow pathways prior to infusion of chemotherapeutic and other agents into the fourth ventricle.

    PubMed

    Patel, Rajan P; Sitton, Clark W; Ketonen, Leena M; Hou, Ping; Johnson, Jason M; Romo, Seferino; Fletcher, Stephen; Shah, Manish N; Kerr, Marcia; Zaky, Wafik; Rytting, Michael E; Khatua, Soumen; Sandberg, David I

    2018-03-01

    Nuclear medicine studies have previously been utilized to assess for blockage of cerebrospinal fluid (CSF) flow prior to intraventricular chemotherapy infusions. To assess CSF flow without nuclear medicine studies, we obtained cine phase-contrast MRI sequences that assess CSF flow from the fourth ventricle down to the sacrum. In three clinical trials, 18 patients with recurrent malignant posterior fossa tumors underwent implantation of a ventricular access device (VAD) into the fourth ventricle, either with or without simultaneous tumor resection. Prior to infusing therapeutic agents into the VAD, cine MRI phase-contrast CSF flow sequences of the brain and total spine were performed. Velocity encoding (VENC) of 5 and 10 cm/s was used to confirm CSF flow from the fourth ventricular outlets to the cervical, thoracic, and lumbar spine. Qualitative CSF flow was characterized by neuroradiologists as present or absent. All 18 patients demonstrated CSF flow from the outlets of the fourth ventricle down to the sacrum with no evidence of obstruction. One of these patients, after disease progression, subsequently showed obstruction of CSF flow. No patient required a nuclear medicine study to assess CSF flow prior to initiation of infusions. Fourteen patients have received infusions to date, and none has had neurological toxicity. CSF flow including the fourth ventricle and the total spine can be assessed noninvasively with phase-contrast MRI sequences. Advantages over nuclear medicine studies include avoiding both an invasive procedure and radiation exposure.

  3. Opioid abusers’ ability to differentiate an opioid from placebo in laboratory challenge testing*

    PubMed Central

    Antoine, Denis G.; Strain, Eric C.; Tompkins, D. Andrew; Bigelow, George E.

    2013-01-01

    Background Abuse liability assessments influence drug development, federal regulation, and clinical care. One suggested procedure to reduce variability of assessments is a qualification phase, which assesses whether study applicants adequately distinguish active drug from placebo; applicants failing to make this distinction are disqualified. The present analyses assessed differences between qualification phase qualifiers and non-qualifiers. Methods Data were collected from 23 completers of the qualification phase of an abuse liability study. Opioid abusing participants received 30 mg oxycodone and placebo orally on separate days, and were characterized as qualifiers (vs. non-qualifiers) if their peak visual analog scale liking rating for oxycodone was at least 20 points higher than placebo’s peak rating. Groups were compared on demographic characteristics, drug history, and physiologic, subject and observer ratings. Results 61% of participants were qualifiers and 39% were non-qualifiers. Groups had similar demographic characteristics, drug use histories, and pupillary constriction responses. However, unlike qualifiers, non-qualifiers had an exaggerated placebo response for the liking score (p=0.03) and an attenuated oxycodone response for the liking score (p<.0001). Non-qualifiers’ failure to differentiate oxycodone versus placebo was evident for subject and observer ratings. Conclusion Different subjective responses to identical stimuli support the use of a qualification phase in abuse liability assessments. Further research should explore objective measures that may better account for these differences, determine optimal qualification criteria, and explore the developmental course of drug use. This study also documents certain opioid abusers fail to differentiate 30 mg of oxycodone from placebo, a phenomenon deserving further study. PMID:23369645

  4. Phased Array Ultrasonic Sound Field Mapping in Cast Austenitic Stainless Steel

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

    Crawford, Susan L.; Prowant, Matthew S.; Cinson, Anthony D.

    2014-05-31

    This study maps the phased array-generated acoustic sound fields through three types of CASS microstructure in four specimens to quantitatively assess the beam formation effectiveness in these materials.

  5. Neuropsychiatric symptoms and quality of life in patients in the final phase of dementia.

    PubMed

    Koopmans, Raymond T C M; van der Molen, Marloes; Raats, Monique; Ettema, Teake P

    2009-01-01

    To assess neuropsychiatric symptoms and quality of life in a group of patients in the final phase of dementia. All patients with dementia (n = 216) residing on dementia special care units of two Dutch nursing homes were included in the study provided they met the criteria for the final phase of dementia. Neuropsychiatric symptoms were assessed with the Neuropsychiatric Inventory Nursing Home version (NPI-NH) and the Cohen Mansfield Agitation Inventory (CMAI). Quality of life was assessed with the QUALIDEM. Of the 216 dementia patients 39 met the criteria for the final phase of dementia. The patients showed a specific pattern of behaviours with a high prevalence of apathy, agitation and behaviours that were mainly observed during morning care such as making strange noises, grabbing, performing repetitious mannerism, spitting, hitting, screaming and pushing. Overall quality of life of these patients in the final phase of dementia was moderate. In this small sample, patients in the final phase of dementia show specific behavioural problems, that mainly should be addressed with psychosocial interventions. (c) 2008 John Wiley & Sons, Ltd.

  6. 25 CFR 900.112 - What are construction phases?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... phase. The phase during which an initial assessment and determination of project need is made and... services are provided. This phase can include conducting and preparing a detailed needs assessment... assessments and associated activities. ...

  7. 25 CFR 900.112 - What are construction phases?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... phase. The phase during which an initial assessment and determination of project need is made and... services are provided. This phase can include conducting and preparing a detailed needs assessment... assessments and associated activities. ...

  8. 25 CFR 900.112 - What are construction phases?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... phase. The phase during which an initial assessment and determination of project need is made and... services are provided. This phase can include conducting and preparing a detailed needs assessment... assessments and associated activities. ...

  9. 25 CFR 900.112 - What are construction phases?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... phase. The phase during which an initial assessment and determination of project need is made and... services are provided. This phase can include conducting and preparing a detailed needs assessment... assessments and associated activities. ...

  10. 25 CFR 900.112 - What are construction phases?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... phase. The phase during which an initial assessment and determination of project need is made and... services are provided. This phase can include conducting and preparing a detailed needs assessment... assessments and associated activities. ...

  11. Profiles and clinical management of hepatitis C patients in Spain: disHCovery study.

    PubMed

    Buti, Maria; Franco, Alejandro; Carmona, Isabel; Sánchez-Ruano, Juan Jose; Sansó, Andreu; Berenguer, Marina; García-Buey, Luisa; Hernández-Guerra, Manuel; Morillas, Rosa Maria; Ledesma, Francisco; Esteban, Rafael

    2015-06-01

    To assess the clinical profile and management of patients with hepatitis C (HCV) infection in an observational study in Spanish hospitals. The study included an initial cross-sectional phase (study phase I), in which investigators at 48 hospitals from 14 Spanish regions collected data from approximately 20 consecutive patients each (a total of 1,000 patients) to assess the general features of HCV-infected patients of any genotype. During the second phase (study phase II), data from 878 patients that were infected exclusively with genotype 1 HCV were assessed retrospectively. Eight pre-defined clinical profiles were established, in order to assess clinical and previous treatments characteristics. Among the HCV-infected individuals that were analysed during the first part, HCV genotype 1 was found to be predominant (with a prevalence of 76.6%), prevailing the subtype 1b (69.8%), with other significant groups infected by genotype 3 (12.3%) and 4 (7.4%). In the second part of the study, 44% of the HCV genotype 1-infected patients were at a F3/F4 fibrosis stage. 15.9% had never been treated, and previously unsuccessfully treated patients that were no longer receiving anti-HCV treatment accounted for 50.8% of cases. Individuals with a sustained virologic response (SVR) to previous dual therapies (based on Interferon and Ribavirin) were only 14.5% and patients under treatment during the study accounted for the remaining 18.8%. A total of 713 patients (81.2%) in the second phase were not receiving any type of therapy over the period analysed, mainly due to the anticipation of new anti-HCV drugs (41.8%), SVR achievement (17.8%) and unresponsiveness to therapies available at the time of the study (9.5%). HCV genotype 1, predominately 1b, is the most prevalent type in Spain. Advanced fibrosis or cirrhosis is frequent in this group, mainly patients not yet cured.

  12. Effect of Air Pollution on Menstrual Cycle Length—A Prognostic Factor of Women’s Reproductive Health

    PubMed Central

    Merklinger-Gruchala, Anna; Jasienska, Grazyna; Kapiszewska, Maria

    2017-01-01

    Air pollution can influence women’s reproductive health, specifically menstrual cycle characteristics, oocyte quality, and risk of miscarriage. The aim of the study was to assess whether air pollution can affect the length of the overall menstrual cycle and the length of its phases (follicular and luteal). Municipal ecological monitoring data was used to assess the air pollution exposure during the monitored menstrual cycle of each of 133 woman of reproductive age. Principal component analyses were used to group pollutants (PM10, SO2, CO, and NOx) to represent a source-related mixture. PM10 and SO2 assessed separately negatively affected the length of the luteal phase after standardization (b = −0.02; p = 0.03; b = −0.06; p = 0.02, respectively). Representing a fossil fuel combustion emission, they were also associated with luteal phase shortening (b = −0.32; p = 0.02). These pollutants did not affect the follicular phase length and overall cycle length, neither in single- nor in multi-pollutant models. CO and NOx assessed either separately or together as a traffic emission were not associated with overall cycle length or the length of cycle phases. Luteal phase shortening, a possible manifestation of luteal phase deficiency, can result from fossil fuel combustion. This suggests that air pollution may contribute to fertility problems in women. PMID:28726748

  13. MDCT of acute pancreatitis: Intraindividual comparison of single-phase versus dual-phase MDCT for initial assessment of acute pancreatitis using different CT scoring systems.

    PubMed

    Avanesov, Maxim; Weinrich, Julius M; Kraus, Thomas; Derlin, Thorsten; Adam, Gerhard; Yamamura, Jin; Karul, Murat

    2016-11-01

    The purpose of the retrospective study was to evaluate the additional value of dual-phase multidetector computed tomography (MDCT) protocols over a single-phase protocol on initial MDCT in patients with acute pancreatitis using three CT-based pancreatitis severity scores with regard to radiation dose. In this retrospective, IRB approved study MDCT was performed in 102 consecutive patients (73 males; 55years, IQR48-64) with acute pancreatitis. Inclusion criteria were CT findings of interstitial edematous pancreatitis (IP) or necrotizing pancreatitis (NP) and a contrast-enhanced dual-phase (arterial phase and portal-venous phase) abdominal CT performed at ≥72h after onset of symptoms. The severity of pancreatic and extrapancreatic changes was independently assessed by 2 observers using 3 validated CT-based scoring systems (CTSI, mCTSI, EPIC). All scores were applied to arterial phase and portal venous phase scans and compared to score results of portal venous phase scans, assessed ≥14days after initial evaluation. For effective dose estimation, volume CT dose index (CTDIvol) and dose length product (DLP) were recorded in all examinations. In neither of the CT severity scores a significant difference was observed after application of a dual-phase protocol compared with a single-phase protocol (IP: CTSI: 2.7 vs. 2.5, p=0.25; mCTSI: 4.0 vs. 4.0, p=0.10; EPIC: 2.0 vs. 2.0, p=0.41; NP: CTSI: 8.0 vs. 7.0, p=0.64; mCTSI: 8.0 vs. 8.0, p=0.10; EPIC: 3.0 vs. 3.0, p=0.06). The application of a single-phase CT protocol was associated with a median effective dose reduction of 36% (mean dose reduction 31%) compared to a dual-phase CT scan. An initial dual-phase abdominal CT after ≥72h after onset of symptoms of acute pancreatitis was not superior to a single-phase protocol for evaluation of the severity of pancreatic and extrapancreatic changes. However, the effective radiation dose may be reduced by 36% using a single-phase protocol. Copyright © 2016. Published by Elsevier Ireland Ltd.

  14. Scientific white paper on concentration-QTc modeling.

    PubMed

    Garnett, Christine; Bonate, Peter L; Dang, Qianyu; Ferber, Georg; Huang, Dalong; Liu, Jiang; Mehrotra, Devan; Riley, Steve; Sager, Philip; Tornoe, Christoffer; Wang, Yaning

    2018-06-01

    The International Council for Harmonisation revised the E14 guideline through the questions and answers process to allow concentration-QTc (C-QTc) modeling to be used as the primary analysis for assessing the QTc interval prolongation risk of new drugs. A well-designed and conducted QTc assessment based on C-QTc modeling in early phase 1 studies can be an alternative approach to a thorough QT study for some drugs to reliably exclude clinically relevant QTc effects. This white paper provides recommendations on how to plan and conduct a definitive QTc assessment of a drug using C-QTc modeling in early phase clinical pharmacology and thorough QT studies. Topics included are: important study design features in a phase 1 study; modeling objectives and approach; exploratory plots; the pre-specified linear mixed effects model; general principles for model development and evaluation; and expectations for modeling analysis plans and reports. The recommendations are based on current best modeling practices, scientific literature and personal experiences of the authors. These recommendations are expected to evolve as their implementation during drug development provides additional data and with advances in analytical methodology.

  15. Ecological risk assessment for Mather Air Force Base, California: Phase 1, screening assessment

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

    Meyers-Schoene, L.; Fischer, N.T.; Rabe, J.J.

    Mather Air Force Base (AFB) is among the numerous facilities scheduled for closure under the US Air Force (USAF) Installation Restoration Program (IRP). A component of the Mather AFB IRP is to prepare risk assessments for each of the chemically contaminated sites. Because no previous ecological risk related studies have been conducted on Mather AFB, the authors proposed a phased approach to assessing ecological risks at the base. Phase 1 consisted of baseline ecological surveys that collected data over a 12-month period. In addition, benchmark screening criteria were used in conjunction with modeling results that utilized measured concentrations of chemicalmore » analytes in abiotic samples. Phase 2 may consist of the collection of more site-specific data and toxicity testing, if warranted by the Phase 1 screening analysis. This approach was in agreement with the USAF`s ecological risk assessment guidance and met the approval of the Air Force and USEPA Region 9. The authors found the use of established and derived screening values to effectively aid in the focusing of the ecological risk assessment on those chemicals most likely to be hazardous to ecological receptors at the base. Disadvantages in the use of screening values include the uncertainties associated with the conservative assumptions inherent in the derivation of benchmark values and the difficulty in extrapolating from laboratory determined benchmark values to impacts in the field.« less

  16. Organizational justice and sleeping problems: The Whitehall II study.

    PubMed

    Elovainio, Marko; Ferrie, Jane E; Gimeno, David; De Vogli, Roberto; Shipley, Martin; Brunner, Eric J; Kumari, Meena; Vahtera, Jussi; Marmot, Michael G; Kivimäki, Mika

    2009-04-01

    To test the hypothesis that organizational injustice contributes to sleeping problems. Poor sleep quality can be a marker of prolonged emotional stress and has been shown to have serious effects on the immune system and metabolism. Data were from the prospective Whitehall II study of white-collar British civil servants (3143 women and 6895 men, aged 35-55 years at baseline). Age, employment grade, health behaviors, and depressive symptoms were measured at Phase 1 (1985-1988) and baseline sleeping problems were assessed at Phase 2 (1989-1990). Organizational justice was assessed twice, at Phases 1 and 2. The outcome was mean of sleeping problems during Phases 5 (1997-1999) and 7 (2003-2004). In men, low organizational justice at Phase 1 and Phase 2 were associated with overall sleeping problems, sleep maintenance problems, sleep onset problems, and nonrefreshing sleep at Phases 5 and 7. In women, a significant association was observed between low organizational justice and overall sleeping problems and sleep onset problems. These associations were robust to adjustments for age, employment grade, health behaviors, job strain, depressive symptoms, and sleeping problems at baseline. This study shows that perceived unfair treatment at workplace is associated with increased risk of poor sleep quality in men and women, one potential mechanism through which justice at work may affect health.

  17. Development and validation of a fatigue assessment scale for U.S. construction workers.

    PubMed

    Zhang, Mingzong; Sparer, Emily H; Murphy, Lauren A; Dennerlein, Jack T; Fang, Dongping; Katz, Jeffrey N; Caban-Martinez, Alberto J

    2015-02-01

    To develop a fatigue assessment scale and test its reliability and validity for commercial construction workers. Using a two-phased approach, we first identified items (first phase) for the development of a Fatigue Assessment Scale for Construction Workers (FASCW) through review of existing scales in the scientific literature, key informant interviews (n = 11) and focus groups (three groups with six workers each) with construction workers. The second phase included assessment for the reliability, validity, and sensitivity of the new scale using a repeated-measures study design with a convenience sample of construction workers (n = 144). Phase one resulted in a 16-item preliminary scale that after factor analysis yielded a final 10-item scale with two sub-scales ("Lethargy" and "Bodily Ailment"). During phase two, the FASCW and its subscales demonstrated satisfactory internal consistency (alpha coefficients were FASCW [0.91], Lethargy [0.86] and Bodily Ailment [0.84]) and acceptable test-retest reliability (Pearson Correlations Coefficients: 0.59-0.68; Intraclass Correlation Coefficients: 0.74-0.80). Correlation analysis substantiated concurrent and convergent validity. A discriminant analysis demonstrated that the FASCW differentiated between groups with arthritis status and different work hours. The 10-item FASCW with good reliability and validity is an effective tool for assessing the severity of fatigue among construction workers. © 2015 Wiley Periodicals, Inc.

  18. NACASETAC BAY: AN INTERACTIVE CASE STUDY

    EPA Science Inventory

    This interactive case study or "game" was created to provide a "hands on" experience in the application of a weight of evidence approach to sediment assessment. The game proceeds in two phases. In each phase the players work together as a group. A scenario is presented, and the g...

  19. Chemoradiation in elderly esophageal cancer patients: rationale and design of a phase I/II multicenter study (OSAGE).

    PubMed

    Servagi-Vernat, Stéphanie; Créhange, Gilles; Bonnetain, Franck; Mertens, Cécile; Brain, Etienne; Bosset, Jean François

    2017-07-13

    The management of elderly patients with cancer is a therapeutic challenge and a public health problem. Definitive chemoradiotherapy (CRT) is an accepted standard treatment for patients with locally advanced esophageal cancer who cannot undergo surgery. However, there are few reports regarding tolerance to CRT in elderly patients. We previously reported results for CRT in patients aged ≥75 years. Following this first phase II trial, we propose to conduct a phase I/II study to evaluate the combination of carboplatin and paclitaxel, with concurrent RT in unresectable esophageal cancer patients aged 75 years or older. This prospective multicenter phase I/II study will include esophageal cancer in patients aged 75 years or older. Study procedures will consist to determinate the tolerated dose of chemotherapy (Carboplatin, paclitaxel) and of radiotherapy (41.4-45 and 50.4 Gy) in the phase I. Efficacy will be assessed using a co-primary endpoint encompassing health related quality of life and the progression-free survival in the phase II with the dose recommended of CRT in the phase I. This geriatric evaluation was defined by the French geriatric oncology group (GERICO). This trial has been designed to assess the tolerated dose of CRT in selected patient aged 75 years or older. Clinicaltrials.gov ID: NCT02735057 . Registered on 18 March 2016.

  20. Prevalence of delayed-onset posttraumatic stress disorder in military personnel: is there evidence for this disorder?: Results of a prospective UK cohort study.

    PubMed

    Goodwin, Laura; Jones, Margaret; Rona, Roberto J; Sundin, Josefin; Wessely, Simon; Fear, Nicola T

    2012-05-01

    Delayed-onset posttraumatic stress disorder (PTSD) is defined as onset at least 6 months after a traumatic event. This study investigates the prevalence of delayed-onset PTSD in 1397 participants from a two-phase prospective cohort study of UK military personnel. Delayed-onset PTSD was categorized as participants who did not meet the criteria for probable PTSD (assessed using the PTSD Checklist Civilian version) at phase 1 but met the criteria by phase 2. Of the participants, 3.5% met the criteria for delayed-onset PTSD. Subthreshold PTSD, common mental disorder (CMD), poor/fair self-reported health, and multiple physical symptoms at phase 1 and the onset of alcohol misuse or CMD between phases 1 and 2 were associated with delayed-onset PTSD. Delayed-onset PTSD exists in this UK military sample. Military personnel who developed delayed-onset PTSD were more likely to have psychological ill-health at an earlier assessment, and clinicians should be aware of the potential comorbidity in these individuals, including alcohol misuse. Leaving the military or experiencing relationship breakdown was not associated.

  1. Comparative Study of Solution Phase and Vapor Phase Deposition of Aminosilanes on Silicon Dioxide Surfaces

    PubMed Central

    Yadav, Amrita R.; Sriram, Rashmi; Carter, Jared A.; Miller, Benjamin L.

    2014-01-01

    The uniformity of aminosilane layers typically used for the modification of hydroxyl bearing surfaces such as silicon dioxide is critical for a wide variety of applications, including biosensors. However, in spite of many studies that have been undertaken on surface silanization, there remains a paucity of easy-to-implement deposition methods reproducibly yielding smooth aminosilane monolayers. In this study, solution- and vapor-phase deposition methods for three aminoalkoxysilanes differing in the number of reactive groups (3-aminopropyl triethoxysilane (APTES), 3-aminopropyl methyl diethoxysilane (APMDES) and 3-aminopropyl dimethyl ethoxysilane (APDMES)) were assessed with the aim of identifying methods that yield highly uniform and reproducible silane layers that are resistant to minor procedural variations. Silane film quality was characterized based on measured thickness, hydrophilicity and surface roughness. Additionally, hydrolytic stability of the films was assessed via these thickness and contact angle values following desorption in water. We found that two simple solution-phase methods, an aqueous deposition of APTES and a toluene based deposition of APDMES, yielded high quality silane layers that exhibit comparable characteristics to those deposited via vapor-phase methods. PMID:24411379

  2. Outcomes of Patients With Relapsed Hepatoblastoma Enrolled on Children's Oncology Group (COG) Phase I and II Studies.

    PubMed

    Trobaugh-Lotrario, Angela D; Meyers, Rebecka L; Feusner, James H

    2016-04-01

    Data are limited regarding outcomes of patients treated for relapsed hepatoblastoma. We reviewed enrollment patterns and outcomes of patients with hepatoblastoma on Children's Oncology Group (COG) phase I/II studies. The medical literature was searched for reports of COG phase I/II studies using PUBMED as well as an inventory from the COG publications office searching manuscripts published from 2000 to 2014. Seventy-one patients with relapsed hepatoblastoma were enrolled on 23 separate COG phase I/II studies. Four studies collected α-fetoprotein (AFP) data, but none utilized AFP decline in assessing response. Most studies enrolled few patients with relapsed hepatoblastoma: 7 studies enrolled 1 patient, and another 7 studies enrolled 2 patients each. Only 9 studies enrolled 3 or more patients with relapsed hepatoblastoma. Four responses were reported. Dedicated strata and/or focus on 1 or 2 studies with compelling biological or clinical rationale for hepatoblastoma may improve accrual (and statistical significance of response data) of patients with relapsed hepatoblastoma. Prospective study of AFP decline versus RECIST response could help determine the optimal method of assessing response to identify potentially beneficial treatments in hepatoblastoma.

  3. Assessing Online Collaborative Discourse.

    PubMed

    Breen, Henny

    2015-01-01

    This qualitative study using transcript analysis was undertaken to clarify the value of Harasim's Online Collaborative Learning Theory as a way to assess the collaborative process within nursing education. The theory incorporated three phases: (a) idea generating; (b) idea organizing; and (c) intellectual convergence. The transcripts of asynchronous discussions from a 2-week module about disaster nursing using a virtual community were analyzed and formed the data for this study. This study supports the use of Online Collaborative Learning Theory as a framework for assessing online collaborative discourse. Individual or group outcomes were required for the students to move through all three phases of the theory. The phases of the Online Collaborative Learning Theory could be used to evaluate the student's ability to collaborate. It is recommended that group process skills, which have more to do with interpersonal skills, be evaluated separately from collaborative learning, which has more to do with cognitive skills. Both are required for practicing nurses. When evaluated separately, the student learning needs are more clearly delineated. © 2014 Wiley Periodicals, Inc.

  4. Improving Escalation of Care: Development and Validation of the Quality of Information Transfer Tool.

    PubMed

    Johnston, Maximilian J; Arora, Sonal; Pucher, Philip H; Reissis, Yannis; Hull, Louise; Huddy, Jeremy R; King, Dominic; Darzi, Ara

    2016-03-01

    To develop and provide validity and feasibility evidence for the QUality of Information Transfer (QUIT) tool. Prompt escalation of care in the setting of patient deterioration can prevent further harm. Escalation and information transfer skills are not currently measured in surgery. This study comprised 3 phases: the development (phase 1), validation (phase 2), and feasibility analysis (phase 3) of the QUIT tool. Phase 1 involved identification of core skills needed for successful escalation of care through literature review and 33 semistructured interviews with stakeholders. Phase 2 involved the generation of validity evidence for the tool using a simulated setting. Thirty surgeons assessed a deteriorating postoperative patient in a simulated ward and escalated their care to a senior colleague. The face and content validity were assessed using a survey. Construct and concurrent validity of the tool were determined by comparing performance scores using the QUIT tool with those measured using the Situation-Background-Assessment-Recommendation (SBAR) tool. Phase 3 was conducted using direct observation of escalation scenarios on surgical wards in 2 hospitals. A 7-category assessment tool was developed from phase 1 consisting of 24 items. Twenty-one of 24 items had excellent content validity (content validity index >0.8). All 7 categories and 18 of 24 (P < 0.05) items demonstrated construct validity. The correlation between the QUIT and SBAR tools used was strong indicating concurrent validity (r = 0.694, P < 0.001). Real-time scoring of escalation referrals was feasible and indicated that doctors currently have better information transfer skills than nurses when faced with a deteriorating patient. A validated tool to assess information transfer for deteriorating surgical patients was developed and tested using simulation and real-time clinical scenarios. It may improve the quality and safety of patient care on the surgical ward.

  5. Beginning Teacher Evaluation Study: Phase II, 1973-74, Final Report: Volume III.2. Reading and Mathematics Observation System: Description and Analysis of Time Expenditures.

    ERIC Educational Resources Information Center

    Calfee, Robert; Calfee, Kathryn Hoover

    The Beginning Teacher Evaluation Study (BTES), Phase II, was a research project on effective teaching behavior--what teachers do that significantly affects what and how pupils learn. The purposes of Phase II were to (1) develop an assessment system for measuring teacher and pupil behaviors and other factors which could influence each of them and…

  6. Developing Pro-Environmental Behaviour: Ecotourism Fieldtrip and Experiences

    ERIC Educational Resources Information Center

    Ting, Ding Hooi; Cheng, Charles Fang Chin

    2017-01-01

    Purpose: This study aims to assess the effectiveness of a student participatory approach and assessment to achieve an environmentally friendly behaviour and change strategy. Design/methodology/approach Three time-phase studies employed a participatory and experiential case in the form of ecotourism experiential learning and assessment using a…

  7. Change in women's eating habits during the menstrual cycle.

    PubMed

    Kammoun, Ines; Ben Saâda, Wafa; Sifaou, Amira; Haouat, Emna; Kandara, Hajer; Ben Salem, Leila; Ben Slama, Claude

    2017-02-01

    During the menstrual cycle, the influence of hormonal variations on dietary habits in women has been suggested by several studies. In this context, our work aimed to assess the spontaneous food intake and the anthropometric parameters of women at different periods of their menstrual cycles. This prospective study included 30 healthy women with regular periods (28 to 30 days), aged between 18 and 45. We assessed the spontaneous food intake and the anthropometric measurements (weight and waist circumference) of the participants, during the follicular, peri-ovulatory and luteal phases of their menstrual cycles. Our results showed a slight but significant increase in body weight during the luteal phase (P=0.022) and the follicular phase (P=0.017) compared with the peri-ovulatory phase, without any significant change in waist circumference. The caloric intake increased during the peri-ovulatory (P<0.001) and the luteal phases (P<0.001), compared with the follicular phase, with a significant increase in carbohydrate (P<0.001), lipid (P=0.008) and protein (P=0.008) intake. Our study showed a significant decrease in women's weight during the peri-ovulatory phase, with a significant increase in caloric intake during the luteal phase of the menstrual cycle. Divergent results have been reported by other authors and the physiopathology of these changes is still poorly understood. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  8. Development and validation of the knowledge and attitudes regarding antibiotics and resistance (KAAR-11) questionnaire for primary care physicians.

    PubMed

    López-Vázquez, Paula; Vázquez-Lago, Juan Manuel; Gonzalez-Gonzalez, Cristian; Piñeiro-Lamas, María; López-Durán, Ana; Herdeiro, Maria Teresa; Figueiras, Adolfo

    2016-10-01

    The aim of this study was to develop a novel, self-administered questionnaire to identify primary-care physicians' knowledge and attitudes regarding antibiotics and resistance (KAAR). The study population comprised primary care physicians. The study was conducted in five phases. Phase I consisted of a systematic review and qualitative focus-group study (n = 33 physicians), in which items were formulated so as to be measured on a continuous, visual analogue scale (VAS); in Phase II, content validation and face validity were evaluated by a panel of experts, which reformulated, added and deleted items; Phase III consisted of a pilot study on a population possessing similar characteristics (n = 15); in Phase IV, we analysed reliability by means of a test-retest study (n = 91) and calculated the intraclass correlation coefficients (ICCs); and in Phase V, we assessed construct validity by applying the known-groups technique, measuring the differences between contrasting groups of physicians formed according to antibiotic prescription quality indicators (group 1, n = 156 versus group 2, n = 191). Following Phases I and II, the questionnaire contained 16 knowledge and attitude items. Participants in the pilot study (Phase III) reported no difficulty. The test-retest study (Phase IV) showed that 11 of the 16 initial knowledge and attitude items yielded an ICC > 0.5, while analysis of known-groups validity (Phase V) showed that 13 of the 16 initial items which assessed knowledge and attitudes discriminated between physicians with good and bad indicators of antibiotics prescription. The final 11 item KAAR questionnaire appears to be valid, reliable and responsive. © The Author 2016. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  9. Authentic assessment based showcase portfolio on learning of mathematical problem solving in senior high school

    NASA Astrophysics Data System (ADS)

    Sukmawati, Zuhairoh, Faihatuz

    2017-05-01

    The purpose of this research was to develop authentic assessment model based on showcase portfolio on learning of mathematical problem solving. This research used research and development Method (R & D) which consists of four stages of development that: Phase I, conducting a preliminary study. Phase II, determining the purpose of developing and preparing the initial model. Phase III, trial test of instrument for the initial draft model and the initial product. The respondents of this research are the students of SMAN 8 and SMAN 20 Makassar. The collection of data was through observation, interviews, documentation, student questionnaire, and instrument tests mathematical solving abilities. The data were analyzed with descriptive and inferential statistics. The results of this research are authentic assessment model design based on showcase portfolio which involves: 1) Steps in implementing the authentic assessment based Showcase, assessment rubric of cognitive aspects, assessment rubric of affective aspects, and assessment rubric of skill aspect. 2) The average ability of the students' problem solving which is scored by using authentic assessment based on showcase portfolio was in high category and the students' response in good category.

  10. TREATMENT TRIAL AND LONG-TERM FOLLOW-UP EVALUATION AMONG COMORBID YOUTH WITH MAJOR DEPRESSION AND A CANNABIS USE DISORDER.

    PubMed

    Cornelius, Jack R; Salloum, Ihsan M; Ferrell, Robert; Douaihy, Antoine B; Hayes, Jeanie; Kirisci, Levent; Horner, Michelle; Daley, Dennis C

    2012-01-01

    This study compared the acute phase (12-week) and the long-term (1 year) efficacy of fluoxetine versus placebo for the treatment of the depressive symptoms and the cannabis use of youth with comorbid major depressive disorder (MDD) and an cannabis use disorder (CUD)(cannabis dependence or cannabis abuse). We hypothesized that fluoxetine would demonstrate efficacy in the acute phase trial and at the 1-year follow-up evaluation. Data is also provided regarding the prevalence of risky sexual behaviors in our study sample. We recently completed the first double-blind placebo-controlled study of fluoxetine in adolescents and young adults with comorbid MDD/CUD. A total of 70 persons participated in the acute phase trial, and 68 of those persons (97%) also participated in the 1-year follow-up evaluation. Results of the acute phase study have already been presented (Cornelius, Bukstein, et al., 2010), but the results of the 1 year follow-up assessment have not been published previously. All participants in both treatment groups also received manual-based cognitive behavioral therapy (CBT) and motivation enhancement therapy (MET) during the 12-week course of the study. The 1-year follow-up evaluation was conducted to assess whether the clinical improvements noted during the acute phase trial persisted long term. During the acute phase trial, subjects in both the fluoxetine group and the placebo group showed significant within-group improvement in depressive symptoms and in cannabis-related symptoms. However, no significant difference was noted between the floxetine group and the placebo group on any treatment outcome variable during the acute phase trial. End of study levels of depressive symptoms were low in both the fluoxetine group and the placebo group. Most of the clinical improvements in depressive symptoms and for cannabis-related symptoms persisted at the 1-year follow-up evaluation. Fluoxetine did not demonstrate greater efficacy than placebo for treating either the depressive symptoms or the cannabis-related symptoms of our study sample during the acute phase study or at the 1-year follow-up assessment. The lack of a significant treatment effect for fluoxetine may at least in part reflect efficacy of the CBT/MET psychotherapy. A persistence of the efficacy of the acute phase treatment was noted at the 1-year follow-up evaluation, suggesting long-term effectiveness for the CBT/MET psychotherapy.

  11. Phase V of Early Restoration | NOAA Gulf Spill Restoration

    Science.gov Websites

    Phase V Early Restoration Plan and Environmental Assessment. The project will acquire land along Florida million. Phase V Early Restoration Plan and Environmental Assessment (pdf, 10 MB) Draft Phase V Early Restoration Plan and Environmental Assessment (Executive Summary) (2 MB) Phase V Fact Sheet (pdf, 2 MB) Gulf

  12. Clinical evaluation of new automatic coronary-specific best cardiac phase selection algorithm for single-beat coronary CT angiography.

    PubMed

    Wang, Hui; Xu, Lei; Fan, Zhanming; Liang, Junfu; Yan, Zixu; Sun, Zhonghua

    2017-01-01

    The aim of this study was to evaluate the workflow efficiency of a new automatic coronary-specific reconstruction technique (Smart Phase, GE Healthcare-SP) for selection of the best cardiac phase with least coronary motion when compared with expert manual selection (MS) of best phase in patients with high heart rate. A total of 46 patients with heart rates above 75 bpm who underwent single beat coronary computed tomography angiography (CCTA) were enrolled in this study. CCTA of all subjects were performed on a 256-detector row CT scanner (Revolution CT, GE Healthcare, Waukesha, Wisconsin, US). With the SP technique, the acquired phase range was automatically searched in 2% phase intervals during the reconstruction process to determine the optimal phase for coronary assessment, while for routine expert MS, reconstructions were performed at 5% intervals and a best phase was manually determined. The reconstruction and review times were recorded to measure the workflow efficiency for each method. Two reviewers subjectively assessed image quality for each coronary artery in the MS and SP reconstruction volumes using a 4-point grading scale. The average HR of the enrolled patients was 91.1±19.0bpm. A total of 204 vessels were assessed. The subjective image quality using SP was comparable to that of the MS, 1.45±0.85 vs 1.43±0.81 respectively (p = 0.88). The average time was 246 seconds for the manual best phase selection, and 98 seconds for the SP selection, resulting in average time saving of 148 seconds (60%) with use of the SP algorithm. The coronary specific automatic cardiac best phase selection technique (Smart Phase) improves clinical workflow in high heart rate patients and provides image quality comparable with manual cardiac best phase selection. Reconstruction of single-beat CCTA exams with SP can benefit the users with less experienced in CCTA image interpretation.

  13. Measuring quality progress

    NASA Astrophysics Data System (ADS)

    Lambert, Larry D.

    The study by the American Productivity & Quality Center (APQC) was commissioned by Loral Space Information Systems, Inc. and the National Aeronautics and Space Administration (NASA) to evaluate internal assessment systems. APQC benchmarked approaches to the internal assessment of quality management systems in three phases. The first phase included work conducted for the International Benchmarking Clearinghouse (IBC) and consisted of an in-depth analysis of the 1991 Malcolm Baldrige National Quality Award criteria. The second phase was also performed for the IBC and compared the 1991 award criteria among the following quality awards: Deming Prize, Malcolm Baldrige National Quality Award, The President's Award for Quality and Productivity Improvement, The NASA Excellence Award (The George M. Lowe Trophy) for Quality and Productivity Improvement and the Shigeo Shingo Award for Excellence in Manufacturing. The third phase compared the internal implementation approaches of 23 companies selected from American industry for their recognized, formal assessment systems.

  14. Measuring quality progress

    NASA Technical Reports Server (NTRS)

    Lambert, Larry D.

    1992-01-01

    The study by the American Productivity & Quality Center (APQC) was commissioned by Loral Space Information Systems, Inc. and the National Aeronautics and Space Administration (NASA) to evaluate internal assessment systems. APQC benchmarked approaches to the internal assessment of quality management systems in three phases. The first phase included work conducted for the International Benchmarking Clearinghouse (IBC) and consisted of an in-depth analysis of the 1991 Malcolm Baldrige National Quality Award criteria. The second phase was also performed for the IBC and compared the 1991 award criteria among the following quality awards: Deming Prize, Malcolm Baldrige National Quality Award, The President's Award for Quality and Productivity Improvement, The NASA Excellence Award (The George M. Lowe Trophy) for Quality and Productivity Improvement and the Shigeo Shingo Award for Excellence in Manufacturing. The third phase compared the internal implementation approaches of 23 companies selected from American industry for their recognized, formal assessment systems.

  15. Development and testing of a novel survey to assess Stakeholder-driven Community Diffusion of childhood obesity prevention efforts.

    PubMed

    Korn, Ariella R; Hennessy, Erin; Hammond, Ross A; Allender, Steven; Gillman, Matthew W; Kasman, Matt; McGlashan, Jaimie; Millar, Lynne; Owen, Brynle; Pachucki, Mark C; Swinburn, Boyd; Tovar, Alison; Economos, Christina D

    2018-05-31

    Involving groups of community stakeholders (e.g., steering committees) to lead community-wide health interventions appears to support multiple outcomes ranging from policy and systems change to individual biology. While numerous tools are available to measure stakeholder characteristics, many lack detail on reliability and validity, are not context specific, and may not be sensitive enough to capture change over time. This study describes the development and reliability of a novel survey to measure Stakeholder-driven Community Diffusion via assessment of stakeholders' social networks, knowledge, and engagement about childhood obesity prevention. This study was completed in three phases. Phase 1 included conceptualization and online survey development through literature reviews and expert input. Phase 2 included a retrospective study with stakeholders from two completed whole-of-community interventions. Between May-October 2015, 21 stakeholders from the Shape Up Somerville and Romp & Chomp interventions recalled their social networks, knowledge, and engagement pre-post intervention. We also assessed one-week test-retest reliability of knowledge and engagement survey modules among Shape Up Somerville respondents. Phase 3 included survey modifications and a second prospective reliability assessment. Test-retest reliability was assessed in May 2016 among 13 stakeholders involved in ongoing interventions in Victoria, Australia. In Phase 1, we developed a survey with 7, 20 and 50 items for the social networks, knowledge, and engagement survey modules, respectively. In the Phase 2 retrospective study, Shape Up Somerville and Romp & Chomp networks included 99 and 54 individuals. Pre-post Shape Up Somerville and Romp & Chomp mean knowledge scores increased by 3.5 points (95% CI: 0.35-6.72) and (- 0.42-7.42). Engagement scores did not change significantly (Shape Up Somerville: 1.1 points (- 0.55-2.73); Romp & Chomp: 0.7 points (- 0.43-1.73)). Intraclass correlation coefficients (ICCs) for knowledge and engagement were 0.88 (0.67-0.97) and 0.97 (0.89-0.99). In Phase 3, the modified knowledge and engagement survey modules included 18 and 25 items, respectively. Knowledge and engagement ICCs were 0.84 (0.62-0.95) and 0.58 (0.23-0.86). The survey measures upstream stakeholder properties-social networks, knowledge, and engagement-with good test-retest reliability. Future research related to Stakeholder-driven Community Diffusion should focus on prospective change and survey validation for intervention effectiveness.

  16. Measuring Gait Quality in Parkinson’s Disease through Real-Time Gait Phase Recognition

    PubMed Central

    Mileti, Ilaria; Germanotta, Marco; Di Sipio, Enrica; Imbimbo, Isabella; Pacilli, Alessandra; Erra, Carmen; Petracca, Martina; Del Prete, Zaccaria; Bentivoglio, Anna Rita; Padua, Luca

    2018-01-01

    Monitoring gait quality in daily activities through wearable sensors has the potential to improve medical assessment in Parkinson’s Disease (PD). In this study, four gait partitioning methods, two based on thresholds and two based on a machine learning approach, considering the four-phase model, were compared. The methods were tested on 26 PD patients, both in OFF and ON levodopa conditions, and 11 healthy subjects, during walking tasks. All subjects were equipped with inertial sensors placed on feet. Force resistive sensors were used to assess reference time sequence of gait phases. Goodness Index (G) was evaluated to assess accuracy in gait phases estimation. A novel synthetic index called Gait Phase Quality Index (GPQI) was proposed for gait quality assessment. Results revealed optimum performance (G < 0.25) for three tested methods and good performance (0.25 < G < 0.70) for one threshold method. The GPQI resulted significantly higher in PD patients than in healthy subjects, showing a moderate correlation with clinical scales score. Furthermore, in patients with severe gait impairment, GPQI was found higher in OFF than in ON state. Our results unveil the possibility of monitoring gait quality in PD through real-time gait partitioning based on wearable sensors. PMID:29558410

  17. Monitoring of Cardiorespiratory Signals Using Thermal Imaging: A Pilot Study on Healthy Human Subjects.

    PubMed

    Barbosa Pereira, Carina; Czaplik, Michael; Blazek, Vladimir; Leonhardt, Steffen; Teichmann, Daniel

    2018-05-13

    Heart rate (HR) and respiratory rate (RR) are important parameters for patient assessment. However, current measurement techniques require attachment of sensors to the patient’s body, often leading to discomfort, stress and even pain. A new algorithm is presented for monitoring both HR and RR using thermal imaging. The cyclical ejection of blood flow from the heart to the head (through carotid arteries and thoracic aorta) leads to periodic movements of the head; these vertical movements are used to assess HR. Respiratory rate is estimated by using temperature fluctuations under the nose during the respiratory cycle. To test the viability and feasibility of this approach, a pilot study was conducted with 20 healthy subjects (aged 18⁻36 and 1 aged 50 years). The study consisted of two phases: phase A (frontal view acquisitions) and phase B (side view acquisitions). To validate the results, photoplethysmography and thoracic effort (piezoplethysmography) were simultaneously recorded. High agreement between infrared thermography and ground truth/gold standard was achieved. For HR, the root-mean-square errors (RMSE) for phases A and B were 3.53 ± 1.53 and 3.43 ± 1.61 beats per minute, respectively. For RR, the RMSE between thermal imaging and piezoplethysmography stayed around 0.71 ± 0.30 breaths per minute (phase A). This study demonstrates that infrared thermography may be a promising, clinically relevant alternative for the assessment of HR and RR.

  18. Evaluation of vocal fold vibration with an assessment form for high-speed digital imaging: comparative study between healthy young and elderly subjects.

    PubMed

    Yamauchi, Akihito; Imagawa, Hiroshi; Yokonishi, Hisayuki; Nito, Takaharu; Yamasoba, Tatsuya; Goto, Takao; Takano, Shingo; Sakakibara, Ken-Ichi; Tayama, Niro

    2012-11-01

    We conducted a prospective study with a subjective assessment form for high-speed digital imaging (HSDI) to elucidate the features of vocal fold vibrations in vocally healthy subjects and to clarify gender- and age-related differences. Healthy adult volunteers participated in this study. They were divided into young (aged 35 and younger) and elderly (aged 65 and older) groups, and the scores of an assessment form for HSDI characteristics elaborated at our institution were statistically analyzed. Twenty-six young subjects (males: 9, females: 17; mean age: 27 years) and 20 elderly subjects (males: 8, females: 12; mean age: 72 years) were assigned to our study. Posterior gap and posterior-to-anterior longitudinal phase difference were characteristic to young females, whereas in young males, mucosal wave, anterior-to-posterior longitudinal phase difference, and supraglottic hyperactivity were frequent. In elderly males, axis shift, asymmetry, supraglottic hyperactivity, increased mucosal wave, lateral phase difference, and anterior-to-posterior longitudinal phase difference were frequent; and in elderly females, high incidence of lateral phase difference, atrophic change, anterior gap, and asymmetry were observed. The results show that the behaviors of vocal fold vibrations were diverse even in healthy subjects with no vocal complaints or history of laryngeal diseases, and hence, the diversity of vocal fold vibrations in normal subjects must be taken into account in evaluating vocal fold vibrations. Copyright © 2012 The Voice Foundation. Published by Mosby, Inc. All rights reserved.

  19. Prone positioning reduces severe pushing behavior: three case studies.

    PubMed

    Fujino, Yuji; Amimoto, Kazu; Sugimoto, Satoshi; Fukata, Kazuhiro; Inoue, Masahide; Takahashi, Hidetoshi; Makita, Shigeru

    2016-09-01

    [Purpose] Pushing behavior is classically described as a disorder of body orientation in the coronal plane. Most interventions for pushing behavior have focused on correcting the deviation in vertical perception. However, pushing behavior seems to involve erroneous movements associated with excessive motor output by the non-paretic limbs and trunk. The present study aimed to inhibit muscular hyper-activity by placing the non-paretic limbs and trunk in the prone position. [Subjects and Methods] The subjects of the present study were 3 acute stroke patients with severe pushing behavior. The study consisted of the following 3 phases: baseline, intervention, and follow-up. In addition to conventional therapy, patients received relaxation therapy in the prone position for 10 minutes a day over 2 days. The severity of pushing behavior was assessed using the scale for contraversive pushing, and truncal balance was evaluated using the trunk control test. These assessments were performed before and after the baseline phase, and after the intervention and follow-up phases. [Results] At the baseline phase, both scores were poor. Both scores improved after the intervention and follow-up phases, and all the patients could sit independently. [Conclusion] Relaxation therapy in the prone position might ameliorate pushing behavior and impaired truncal balance.

  20. Water quality monitoring of Sweetwater and Loveland reservoirs--Phase one results 1998-1999

    USGS Publications Warehouse

    Majewski, Michael S.; Sidhu, Jagdeep S.; Mendez, Gregory O.

    2002-01-01

    In 1998, the U.S. Geological Survey began a study to assess the overall health of the watershed feeding the Sweetwater Reservoir in southern San Diego County, California. The study focussed on monitoring for organic chemical contamination and the effects of construction and operation of State Route 125 on water quality. Three environmental compartments (air, water, and bed sediments) are being sampled regularly for chemical contaminants, including volatile organic compounds, polynuclear aromatic hydrocarbons, polychlorinated biphenyls, pesticides, and major and trace elements. The study is divided into two phases. Phase I sampling is designed to establish baseline conditions for target compounds in terms of detection frequency and concentration in air, water, and bed sediments. Phase II sampling will continue at the established monitoring sites during and after construction of State Route 125 to assess chemical impact on water quality in the reservoir resulting from land-use changes and development in the watershed. This report describes the study design, the sampling and analytical methods, and presents the data results for the first year of the study, September 1998 to September 1999.

  1. Assessment of Musculoskeletal Strength and Levels of Fatigue during Different Phases of Menstrual Cycle in Young Adults

    PubMed Central

    D Souza, Urban John; Shivaprakash, G

    2017-01-01

    Introduction Some of the physiological factors and athletic performance might show variation along the phases of menstrual cycle. The alterations seen in these physiological parameters of various systems relating to oscillations in hormonal levels do affect the autonomic nervous system and metabolic functions. Former studies heave inconclusively about the influence of hormones on exercise performance, predominantly muscle strength and rate of fatigue during different phases of the menstrual cycle. Studies regarding influence of these variations during bleeding phase were not done. Aim To evaluate the muscle strength variations and also the rate of fatigue during various phases of the menstrual cycle in young adults. Materials and Methods This was a prospective study conducted among 100 healthy adult female volunteers aged 18-24 years, with normal regular menstrual cycles persistent between 26- 32 days (average of 28 days), for a minimum of last 6 months. Muscle strength was assessed by calculating the work done and fatigue rate using Mosso’s ergograph and by handgrip dynamometer strength. Each subject was evaluated consecutively for two menstrual cycles in all three phases which were classified as Phase 1- Menstrual phase, Phase 2- Follicular phase and Phase 3- Luteal phase. The data obtained was analysed by statistical tool One-way ANOVA followed by a post-hoc Tukeys test. A p-value of ≤ 0.05 was considered significant. Results The amount of work done and handgrip strength was significantly higher in phase 2 (p<0.001) and relatively reduced in phase 1 and 3 (p<0.001) of menstrual cycle. In terms of fatigue rate percentage, phase 2 showed significantly lesser values (p<0.001) as compared to phase 1 and 3 of menstrual cycle. Conclusion We conclude that the cyclical variation in endogenous reproductive hormones increases the muscle strength in follicular phase of the menstrual cycle. Thus provide support for the influence of these hormones in regulation of these parameters in the premenopausal age group. PMID:28384857

  2. Psychosocial Distress of Patients with Psoriasis: Protocol for an Assessment of Care Needs and the Development of a Supportive Intervention.

    PubMed

    Zill, Jördis Maria; Dirmaier, Jörg; Augustin, Matthias; Dwinger, Sarah; Christalle, Eva; Härter, Martin; Mrowietz, Ulrich

    2018-02-07

    Psoriasis is a chronic inflammatory disease that is often associated with a number of somatic and mental comorbidity. Patients with psoriasis show an increased risk of depression and (social) anxiety. The aims of this study are 1) to explore the psychosocial distress of patients with psoriasis and to assess their care needs; and 2) to develop a supportive intervention based on the prior results. A multi-stage design with four phases combining quantitative and qualitative methodology will be used and conducted in two centers. 1) A scoping review and focus groups will be used to design a questionnaire to assess the psychosocial distress and care needs of the patients. 2) The questionnaire developed in phase 1 will be used in a cross-sectional survey to assess the extent of psychosocial distress and supportive care needs in 400 patients with psoriasis. 3) A systematic review and meta-analysis will be conducted to identify psychosocial and psychoeducational interventions for patients with psoriasis and to describe their effectiveness. 4) Based on the results of the phases 2 and 3 a manualized supportive intervention will be developed and the feasibility and acceptance of the intervention will be assessed. Currently, phase 1 of the project has been completed and the recruitment for phase 2 has been started. The systematic review and meta-analysis of phase 3 are conducted simultaneously to phase 2 and results are expected soon. Phase 4 has not been started yet. The expected results of this study will show the extent of psychosocial distress of patients with psoriasis in Germany and supplement previous research with findings about the supportive care needs of this patient group. Moreover, the developed intervention will help to address the psychosocial support needs of patients with psoriasis. Research shows that psychosocial support is strongly needed. ©Jördis Maria Zill, Jörg Dirmaier, Matthias Augustin, Sarah Dwinger, Eva Christalle, Martin Härter, Ulrich Mrowietz. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 07.02.2018.

  3. Impact of tissue atrophy on high-pass filtered MRI signal phase-based assessment in large-scale group-comparison studies: A simulation study

    NASA Astrophysics Data System (ADS)

    Schweser, Ferdinand; Dwyer, Michael G.; Deistung, Andreas; Reichenbach, Jürgen R.; Zivadinov, Robert

    2013-10-01

    The assessment of abnormal accumulation of tissue iron in the basal ganglia nuclei and in white matter plaques using the gradient echo magnetic resonance signal phase has become a research focus in many neurodegenerative diseases such as multiple sclerosis or Parkinson’s disease. A common and natural approach is to calculate the mean high-pass-filtered phase of previously delineated brain structures. Unfortunately, the interpretation of such an analysis requires caution: in this paper we demonstrate that regional gray matter atrophy, which is concomitant with many neurodegenerative diseases, may itself directly result in a phase shift seemingly indicative of increased iron concentration even without any real change in the tissue iron concentration. Although this effect is relatively small results of large-scale group comparisons may be driven by anatomical changes rather than by changes of the iron concentration.

  4. Comparative assessment of the efficacy and safety of sertaconazole (2%) cream versus terbinafine cream (1%) versus luliconazole (1%) cream in patients with dermatophytoses: a pilot study.

    PubMed

    Jerajani, Hr; Janaki, C; Kumar, Sharath; Phiske, Meghana

    2013-01-01

    Sertaconazole is a new, broad spectrum, fungicidal and fungistatic imidazole with added antipruritic and anti-inflammatory activity that would provide greater symptomatic relief and hence would be beneficial in improving the quality of life for the patient with dermatophytoses. To compare efficacy and safety of sertaconazole, terbinafine and luliconazole in patients with dermatophytoses. 83 patients with tinea corporis and tinea cruris infections were enrolled in this multicentre, randomized, open label parallel study. The initial 'Treatment Phase' involved three groups receiving either sertaconazole 2% cream applied topically twice daily for four weeks, terbinafine 1% cream once daily for two weeks, luliconazole 1% cream once daily for two weeks. At the end of treatment phase, there was a 'Follow-up Phase' at end of 2 weeks, where the patients were assessed clinically and mycologically for relapse. Of the 83 patients, 62 completed the study, sertaconazole (n = 20), terbinafine (n = 22) and luliconazole (n = 20). The primary efficacy variables including change in pruritus, erythema, vesicle, desquamation and mycological cure were significantly improved in all the three groups, as compared to baseline, in the Treatment and Follow-up phase. Greater proportion of patients in sertaconazole group (85%) showed resolution of pruritus as compared to terbinafine (54.6%); and luliconazole (70%), (P < 0.05 sertaconazole vs terbinafine). There was a greater reduction in mean total composite score (pruritus, erythema, vesicle and desquamation) in sertaconazole group (97.1%) as compared to terbinafine (91.2%) and luliconazole (92.9%). All groups showed equal negative mycological assessment without any relapses. All three study drugs were well tolerated. Only one patient in sertaconazole group withdrew from the study due to suspected allergic contact dermatitis. Sertaconazole was better than terbinafine and luliconazole in relieving signs and symptoms during study and follow up period. At the end of 'Treatment Phase' and 'Follow-up' Phase, all patients showed negative mycological assessment in all three treatment groups suggesting no recurrence of the disease.

  5. Safety assessment for the postictal confusional phase following complex partial seizure.

    PubMed

    Tucker, C

    1985-06-01

    Misunderstanding of the postictal confusional state that follows the complex partial seizure has caused emotional and physical harm to patients. Concern about this phenomenon and its effects upon the patient prompted this study to explore, describe, and document one method of intervention to lessen these harmful effects. An evaluative descriptive research design was employed to assess patient safety during and after the postictal confusional phase following a complex partial seizure. A closed-structured questionnaire and participant observation were the methods used to collect data for this study. A Level of Safety Tool was specifically designed for this study.

  6. Home Circadian Phase Assessments with Measures of Compliance Yield Accurate Dim Light Melatonin Onsets

    PubMed Central

    Burgess, Helen J.; Wyatt, James K.; Park, Margaret; Fogg, Louis F.

    2015-01-01

    Study Objectives: There is a need for the accurate assessment of circadian phase outside of the clinic/laboratory, particularly with the gold standard dim light melatonin onset (DLMO). We tested a novel kit designed to assist in saliva sampling at home for later determination of the DLMO. The home kit includes objective measures of compliance to the requirements for dim light and half-hourly saliva sampling. Design: Participants were randomized to one of two 10-day protocols. Each protocol consisted of two back-to-back home and laboratory phase assessments in counterbalanced order, separated by a 5-day break. Setting: Laboratory or participants' homes. Participants: Thirty-five healthy adults, age 21–62 y. Interventions: N/A. Measurements and Results: Most participants received at least one 30-sec epoch of light > 50 lux during the home phase assessments (average light intensity 4.5 lux), but on average for < 9 min of the required 8.5 h. Most participants collected every saliva sample within 5 min of the scheduled time. Ninety-two percent of home DLMOs were not affected by light > 50 lux or sampling errors. There was no significant difference between the home and laboratory DLMOs (P > 0.05); on average the home DLMOs occurred 9.6 min before the laboratory DLMOs. The home DLMOs were highly correlated with the laboratory DLMOs (r = 0.91, P < 0.001). Conclusions: Participants were reasonably compliant to the home phase assessment procedures. The good agreement between the home and laboratory dim light melatonin onsets (DLMOs) demonstrates that including objective measures of light exposure and sample timing during home saliva sampling can lead to accurate home DLMOs. Clinical Trial Registration: Circadian Phase Assessments at Home, http://clinicaltrials.gov/show/NCT01487252, NCT01487252. Citation: Burgess HJ, Wyatt JK, Park M, Fogg LF. Home circadian phase assessments with measures of compliance yield accurate dim light melatonin onsets. SLEEP 2015;38(6):889–897. PMID:25409110

  7. Tooth mineralization stages as a diagnostic tool for assessment of skeletal maturity.

    PubMed

    Surendran, Sharmila; Thomas, Eapen

    2014-01-01

    The objective of this study was to determine whether dental calcification can be used as a first-level diagnostic tool for assessment of skeletal maturity. A total of 150 healthy subjects (79 boys, 71 girls; mean age, 12.19 ± 2.03 years; range, 8-16 years) were enrolled in the study. Dental maturity was assessed through the calcification stages from panoramic radiographs of the mandibular canine, the first and second premolars, and the second molar. Determination of skeletal maturity was according to the modified middle phalanx of third finger (MP3) stages method on digital radiographs. Diagnostic ability was evaluated according to the dental maturation stages for each tooth for identification of the MP3 stages and the growth phases (prepubertal, pubertal, postpubertal) using positive likelihood ratios. Dental maturation stage E of the first premolars and the combination of canine stage F, first premolar stage E, second premolar stage E, and second molar stage D (FEED) gave the highest values for identification of the prepubertal growth phase, and stage H of the second molar had the highest value for identification of the postpubertal growth phase. Dental maturation assessment is only useful for diagnosis of the prepubertal and postpubertal growth phases. Copyright © 2014 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

  8. Validation of the Competencies Needed by Vocational Education Teachers, Middle Managers, and Administrators. Phase II of a Professional Development Study for Massachusetts, Volume I.

    ERIC Educational Resources Information Center

    Boston Univ., MA. School of Education.

    This is the first of four volumes reporting phase 2 of a two-phase project to examine the competency-based vocational teacher education movement and analyze the current state of the art (phase 1), and to assess the implications for preservice, inservice, and leadership level professional development programs in career and occupational education in…

  9. Senior Friendly Hospitals: Development and Application of Criteria: A Descriptive Study.

    PubMed

    Rashmi, M R; Kasthuri, Arvind; Rodrigues, Rashmi J

    2016-01-01

    The world's population is rapidly aging. Between 2000 and 2050, the proportion of the world's population over the age of 60 will double from about 11% to 22%; more so in the developing countries. The prevalence of frailty and morbidity among the elderly is high. There is a need to assess the "preparedness" of the health care system including hospitals to respond to the needs of the elderly. 1. To develop criteria for a senior friendly hospital and 2. To assess the feasibility of application of these criteria. A descriptive study was done at Bangalore, India, involving 100 subjects sampled by purposive sampling. Study population consisted of senior citizens, their caretakers, physicians, hospital support staff, nurses, geriatricians, hospital administrators, and architects. They were interviewed using a validated translated interview schedule. The study consisted of two phases; Phase 1: Developing a checklist to assess senior friendliness of a hospital by using modified Delphi technique. Phase 2: Application of the checklist thus developed to selected hospitals in order to assess the feasibility of administration. The data was then analyzed using Statistical Package for the Social Sciences (SPSS) for frequencies, proportions, central tendency and dispersion, interclass reliability, intraclass reliability, and Cronbach's alpha. A checklist containing 44 items to assess the senior friendliness of a hospital was developed. The checklist was found feasible and easy to administer. The checklist thus developed to assess senior friendliness of a hospital has wider application as it has a potential to be considered for framing senior friendly hospital guidelines/policies.

  10. An early oral health care program starting during pregnancy: results of a prospective clinical long-term study.

    PubMed

    Meyer, Karen; Geurtsen, Werner; Günay, Hüsamettin

    2010-06-01

    This study covers phase IV of a prospective clinical long-term study. Objective of this clinical investigation was to analyze the effects of a long-term prevention program on dental and oral health of teenagers at the age of 13 to 14 years. The entire study was subdivided into four phases. Phase I comprised an individual preventive care during pregnancy ("primary-primary prevention"); phase II assessed mothers and their young children until the age of 3 years ("primary prevention"); and in phase III, mothers and children at the age of 6 years were investigated. In phase IV of the study, the oral health of 13- to 14-year-old teenagers was examined (13.4 +/- 0.5 years; n = 29). All phases consisted of an examination, education about oral health care, and treatment based on the concept of an early oral health care promotion. The control group consisted of randomly selected adolescents at the same age (n = 30). The following clinical parameters were assessed: decayed/missing/filled teeth (DMF-T)/decayed, missing, and filled surface teeth index, hygiene index, papilla bleeding index, Periodontal Screening Index, and Streptococcus mutans/Lactobacillus concentration in saliva. The teenagers of the "prevention" group of phase IV of our prospective study revealed a share of 89.7% caries-free dentitions (65.5% sound; 24.2% caries-free with fillings). Mean DMF-T was 0.55 +/- 1.0. The control group showed a significantly higher mean DMF-T of 1.5 +/- 1.5 (p < 0.05) and revealed 56.7% of caries-free dentitions (30% sound, 26.7% caries-free with restorations). Our data clearly document that an early oral health care promotion starting during pregnancy may cause a sustained and long-term improvement of the oral health of children.

  11. Space Station Furnace Facility. Volume 2: Requirements definition and conceptual design study

    NASA Technical Reports Server (NTRS)

    1992-01-01

    The Space Station Freedom Furnace (SSFF) Project is divided into two phases: phase 1, a definition study phase, and phase 2, a design and development phase. TBE was awarded a research study entitled, 'Space Station Furnace Facility Requirements Definition and Conceptual Design Study' on June 2, 1989. This report addresses the definition study phase only. Phase 2 is to be complete after completion of phase 1. The contract encompassed a requirements definition study and culminated in hardware/facility conceptual designs and hardware demonstration development models to test these conceptual designs. The study was divided into two parts. Part 1 (the basic part of the effort) encompassed preliminary requirements definition and assessment; conceptional design of the SSFF Core; fabrication of mockups; and preparation for the support of a conceptional design review (CoDR). Part 2 (the optional part of the effort) included detailed definition of the engineering and design requirements, as derived from the science requirements; refinement of the conceptual design of the SSFF Core; fabrication and testing of the 'breadboards' or development models; and preparation for and support of a requirements definition review.

  12. An assessment of psychological stress and symptomatology for didactic phase physician assistant students.

    PubMed

    Childers, William A; May, Ryan K; Ball, Natalie

    2012-01-01

    The purpose of this study was to assess the amount of psychological stress experienced by didactic phase, physician assistant (PA) students. The Symptom Checklist-90-R (SCL-90-R) survey was administered to 81 students in 2011 during the first two didactic phase semesters at two PA programs. Using ANOVA and t-tests, several variables were analyzed for significance. The SCL-90-R results portray that a significant proportion of the students from both programs reported elevated levels of stress during the first and second semester of the didactic year. Although several significant levels were noted throughout this study, it is not known how these scores from PA students would compare to other medical and/or nonmedical graduate students. Additional studies of stress from both medical and nonmedical graduate students would be beneficial for comparison to PA students.

  13. Gender Matters: Exploring the Process of Developing Resilience through Outdoor Adventure

    ERIC Educational Resources Information Center

    Overholt, Jillisa R.; Ewert, Alan

    2015-01-01

    This two-phase study investigates the process of developing resilience through participation in outdoor adventure programming. In this study, resilience is conceptualized as experiencing growth through a disruptive event. In the first phase, a pre-post survey measure was used to assess resilience in university students who were enrolled in a…

  14. Effect of blonanserin on cognitive and social function in acute phase Japanese schizophrenia compared with risperidone.

    PubMed

    Hori, Hikaru; Yamada, Kenji; Kamada, Dan; Shibata, Yuka; Katsuki, Asuka; Yoshimura, Reiji; Nakamura, Jun

    2014-01-01

    This study aims to determine the effectiveness of blonanserin (BNS) on the cognitive and social functions of patients with schizophrenia compared with risperidone (RIS) during acute-phase (8-week) treatment. A total of 39 schizophrenia inpatients were included in this study. The subjects received either BNS (N=20) or RIS (N=19), and the clinical responses were evaluated periodically. The concomitant use of mood stabilizers was not allowed. Efficacy was assessed with the Positive and Negative Syndrome Scale for schizophrenia. Cognition was assessed using the Brief Assessment of Cognition in Schizophrenia, Japanese-language version. Social function was assessed using the Life Assessment Scale for the Mentally Ill. For both groups, each assessment exhibited a decrease in the mean change from baseline on the Positive and Negative Syndrome Scale. The depression subscale was significantly improved in the BNS group compared with the RIS group at 8 weeks after administration. BNS improved verbal fluency and executive function (cognitive function) and daily living and work skills (social function). Compared with the RIS group, BNS was observed to improve daily living. BNS may improve psychotic symptoms, cognitive function, and daily living in patients with acute-phase schizophrenia. BNS may be superior to RIS in the improvement of daily living.

  15. Effect of blonanserin on cognitive and social function in acute phase Japanese schizophrenia compared with risperidone

    PubMed Central

    Hori, Hikaru; Yamada, Kenji; Kamada, Dan; Shibata, Yuka; Katsuki, Asuka; Yoshimura, Reiji; Nakamura, Jun

    2014-01-01

    Background This study aims to determine the effectiveness of blonanserin (BNS) on the cognitive and social functions of patients with schizophrenia compared with risperidone (RIS) during acute-phase (8-week) treatment. Methods A total of 39 schizophrenia inpatients were included in this study. The subjects received either BNS (N=20) or RIS (N=19), and the clinical responses were evaluated periodically. The concomitant use of mood stabilizers was not allowed. Efficacy was assessed with the Positive and Negative Syndrome Scale for schizophrenia. Cognition was assessed using the Brief Assessment of Cognition in Schizophrenia, Japanese-language version. Social function was assessed using the Life Assessment Scale for the Mentally Ill. Results For both groups, each assessment exhibited a decrease in the mean change from baseline on the Positive and Negative Syndrome Scale. The depression subscale was significantly improved in the BNS group compared with the RIS group at 8 weeks after administration. BNS improved verbal fluency and executive function (cognitive function) and daily living and work skills (social function). Compared with the RIS group, BNS was observed to improve daily living. Conclusion BNS may improve psychotic symptoms, cognitive function, and daily living in patients with acute-phase schizophrenia. BNS may be superior to RIS in the improvement of daily living. PMID:24707178

  16. CAISI Operational Assessment (OA) data collection results. Final report

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

    NONE

    1997-01-31

    One of the lessons learned from Operation Desert Shield/Storm was the inability of deployed Combat Service Support (CSS) computers to exchange data effectively in a battlefield environment. The work-around solution to this previously identified problem has been to physically carry floppy disks between computers. A General Officer Steering Committee, directed by the Vice Chief of Staff of the Army, determined that immediate corrective action was necessary to ensure viability of the CSS Battlefield Mission Area. The study recommended that a three-phased system development plan address short-, mid- and long-term CSS automation communication interface requirements. In response to this study, Programmore » Executive Office (PEO) Standard Army Management Information System (STAMIS) authorized the development of the CSS Automated Information System Interface (CAISI). Phase I (Near-Term) equipped the {open_quotes}first to fight{close_quotes} Contingency Corps units. Phase II (Mid-Term) is being fielded to the remainder of Force Package One units in the active force. Phase III (Long-Term) will equip the remaining units. CAISI is now in the early stages of Phase II fielding. Prior to full Phase II fielding, CAISI must be approved for production by a Milestone III decision authority. Part of the data that will be used in the Milestone III decision is a demonstration of the CAISI`s operational suitability, as assessed by the US Army Operational Test and Evaluation Command (OPTEC). This assessment will be performed through an Operational Assessment (OA) using data provided from previous technical testing, such as the CAISI Customer User Test (CUT), and a field training exercise conducted by units of the XVIII Airborne Corps. The field training exercise data collection took place during two events.« less

  17. A comprehensive study of Superfund program benefits in the Denver and Tampa Bay metropolitan areas

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

    Held, K.; Casper, B.; Siddhanti, S.K.

    1995-12-31

    The purpose of the study is to evaluate the benefits of the Superfund program in selected geographic areas. The study demonstrates how the cleanup of Superfund sites has improved the overall quality of life of those in the affected communities. The study presents findings on the benefits of Superfund cleanup activity in the Denver, Colorado and Tampa Bay, Florida metropolitan areas. Denver and Tampa Bay were chosen from several areas that the EPA evaluated and screened during the initial phase of the study. These locations were chosen because of a substantial presence of Superfund activities, making it possible to assessmore » the efficacy of the program. Several features make this study unique in terms of its overall goal. The study examines a broad range of benefit categories related to human health, environmental, and socioeconomic effects of Superfund cleanup activities. The study is also designed to assess benefits due to completed, current, and future planned activity at Superfund sites. This assessment covers Federal remedial activities at National Priorities List (NPL) sites, as well as relevant Federal removal actions in the study areas. These benefits are investigated from an area-wide perspective, as opposed to site-by-site, to determine Superfund`s overall effect on the communities in each area. The study consists of two major phases: Phase 1: Screening and ranking 16 prospective geographic areas and selecting Denver and Tampa Bay as the most appropriate areas for in-depth analysis; and Phase 2: Developing methodologies for assessing benefits, collecting relevant data, and analyzing the benefits from Superfund cleanup activity.« less

  18. Assessing the Potential Environmental Consequences of a New Energetic Material: A Phased Approach, September 2005

    DTIC Science & Technology

    2007-12-01

    there are no reliable alternatives to animal testing in the determination of toxicity. QSARs are only as reliable as the corroborating toxicological ...2) QSAR approaches can also be used to estimate toxicological impact. Toxicity QSAR models can often predict many toxicity parameters without... Toxicology Study No. 87-XE-03N3-05, Assessing the Potential Environmental Consequences of a New Energetic Material: A Phased Approach, September 2005 1

  19. SELDI Validation Study Phase II — EDRN Public Portal

    Cancer.gov

    This project –A Comprehensive Program for the Validation of Prostate Cancer Early Detection with Novel Protein Identification Techniques -- is divided into three phases. The goal of Phase I was to assess the reproducibility and portability of Surface-Enhanced Laser Desorption and Ionization time-of-flight mass spectrometry (SELDI-TOF-MS) using protein profiles generated from serum. Phase I was recently successfully completed at six institutions using a single source of pooled sera.

  20. Utilizing time-frequency amplitude and phase synchrony measure to assess feedback processing in a gambling task.

    PubMed

    Watts, Adreanna T M; Tootell, Anne V; Fix, Spencer T; Aviyente, Selin; Bernat, Edward M

    2018-04-29

    The neurophysiological mechanisms involved in the evaluation of performance feedback have been widely studied in the ERP literature over the past twenty years, but understanding has been limited by the use of traditional time-domain amplitude analytic approaches. Gambling outcome valence has been identified as an important factor modulating event-related potential (ERP) components, most notably the feedback negativity (FN). Recent work employing time-frequency analysis has shown that processes indexed by the FN are confounded in the time-domain and can be better represented as separable feedback-related processes in the theta (3-7 Hz) and delta (0-3 Hz) frequency bands. In addition to time-frequency amplitude analysis, phase synchrony measures have begun to further our understanding of performance evaluation by revealing how feedback information is processed within and between various brain regions. The current study aimed to provide an integrative assessment of time-frequency amplitude, inter-trial phase synchrony, and inter-channel phase synchrony changes following monetary feedback in a gambling task. Results revealed that time-frequency amplitude activity explained separable loss and gain processes confounded in the time-domain. Furthermore, phase synchrony measures explained unique variance above and beyond amplitude measures and demonstrated enhanced functional integration between medial prefrontal and bilateral frontal, motor, and occipital regions for loss relative to gain feedback. These findings demonstrate the utility of assessing time-frequency amplitude, inter-trial phase synchrony, and inter-channel phase synchrony together to better elucidate the neurophysiology of feedback processing. Copyright © 2017. Published by Elsevier B.V.

  1. The Watcombe housing study: the short-term effect of improving housing conditions on the indoor environment.

    PubMed

    Richardson, George; Barton, Andrew; Basham, Meryl; Foy, Chris; Eick, Susan Ann; Somerville, Margaret

    2006-05-15

    A three-year study (1999-2001) was initiated in the UK to assess the effect of improving housing conditions in 3-4 bedroom, single-family unit, social rented sector houses on the health of the occupants. The houses were randomised into two groups. Phase I houses received extensive upgrading including wet central heating, on demand ventilation, double-glazed doors, cavity wall and roof/loft insulation. An identical intervention for Phase II houses was delayed for one year. As part of this randomised waiting list study, discrete measurements were made of indoor environmental variables in each house, to assess the short-term effects of improving housing conditions on the indoor environment. Variables representative of indoor environmental conditions were measured in the living room, bedroom and outdoors in each of the three years of the study. In 2000, there was a significant difference between the changes from 1999 to 2000 between Phase I (upgraded) and II (not then upgraded) houses for bedroom temperatures (p=0.002). Changes in wall surface dampness and wall dampness in Phase I houses were also significantly different to the change in Phase II houses in 2000 (p=0.001), but by 2001 the Phase I houses had reverted to the same dampness levels they had before upgrading. The housing upgrades increased bedroom temperatures in all houses. Other indoor environmental variables were not affected.

  2. Sources of Self-Efficacy in Mathematics: A Validation Study

    ERIC Educational Resources Information Center

    Usher, Ellen L.; Pajares, Frank

    2009-01-01

    The purpose of this study was to develop and validate items with which to assess A. Bandura's (1997) theorized sources of self-efficacy among middle school mathematics students. Results from Phase 1 (N=1111) were used to develop and refine items for subsequent use. In Phase 2 of the study (N=824), a 39-item, four-factor exploratory model fit best.…

  3. The Comment-Provoking Potential of T-Shirts: A Nonverbal Dimension of Communication Apprehension.

    ERIC Educational Resources Information Center

    Spicer, Christopher H.

    A study was conducted to assess the relationship between printed t-shirts and communication apprehension. In the first phase of the study, self-reports were used to categorize 206 college students as either high or low in communication apprehension. The second phase of the study consisted of others' evaluations of t-shirts worn by selected…

  4. Navigation and Guidance for Low-Thrust Trajectories, LOTNAV

    NASA Astrophysics Data System (ADS)

    Cano, J. L.; Bello, M.; Rodriguez-Canabal, J.

    A number of interplanetary low-thrust missions have already been flown by many space agencies. Examples of already flown missions based on the use of electric propulsion are Deep Space 1, Hayabusa and SMART-1. Many others are already in the assessment phase or in the development phase itself. In such perspective, it is required by the space agencies the procurement and utilisation of assessment tools for fast prototyping in the areas of mission design and navigation. The Low-Thrust Interplanetary Navigation Tool, which is the subject of this paper, allows the mission analyst performing such type of quick assessment studies for the early phases in the development of low-thrust missions. A number of test cases on low-thrust missions are also presented along with the utilities composing the LOTNAV tool.

  5. Effect of patient-centered communication training on discussion and detection of nonadherence in glaucoma.

    PubMed

    Hahn, Steven R; Friedman, David S; Quigley, Harry A; Kotak, Sameer; Kim, Elizabeth; Onofrey, Meaghan; Eagan, Corey; Mardekian, Jack

    2010-07-01

    To assess communication about adherence and to determine the impact of communication skills training on physicians' approach to nonadherence. Sociolinguistic analysis of videotaped community ophthalmologists' encounters with patients with glaucoma before and after training. Patients in both phases and physicians in phase I knew communication was being studied but not what the focus of the study was. In phase II, physicians knew the targeted communication behaviors. Twenty-three ophthalmologists and 100 regularly scheduled patients with glaucoma (50 per phase). An educational program with videotaped vignettes of simulated patient encounters using audience response and role play to teach patient-centered communication skills, including a 4-step adherence assessment and the use of open-ended questions in ask-tell-ask sequences. Physician eliciting an acknowledgment of nonadherence during a clinical encounter compared with acknowledgment of nonadherence during a postvisit research interview (primary outcome), and performance of targeted communication and substantive discussion of adherence. After intervention, physicians increased the proportion of open-ended questions (15% vs 6%; P = 0.001) and specifically about medication taking (82% compared with 18% of encounters; P<0.001). Compared with the absence of ask-tell-ask communication, 32% of phase II encounters included a complete ask-tell-ask sequence, 78% included an ask-tell sequence, and 32% a tell-ask sequence (P<0.001). Three of 4 steps for assessment of adherence were more common in phase II, and substantial discussions of adherence occurred in 86% versus 30% of encounters (P<0.001). In phase II, physicians elicited acknowledgment of nonadherence in 78% (7/9) of those who acknowledged nonadherence in the postvisit interview compared with 25% in phase I (3/12; P = 0.03). This study demonstrates that experienced community physicians significantly improved their communication strategies and ability to detect and address nonadherence after a 3-hour educational program. Proprietary or commercial disclosure may be found after the references. Copyright 2010 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

  6. Reduced 30-day gastrostomy placement mortality following the introduction of a multidisciplinary nutrition support team: a cohort study.

    PubMed

    Hvas, C L; Farrer, K; Blackett, B; Lloyd, H; Paine, P; Lal, S

    2018-06-01

    Percutaneous endoscopic gastrostomy feeding allows patients with dysphagia to receive adequate nutritional support, although gastrostomy insertion is associated with mortality. A nutrition support team (NST) may improve a gastrostomy service. The present study aimed to evaluate the introduction of a NST for assessment and follow-up of patients referred for gastrostomy. We included adult inpatients referred for gastrostomy insertion consecutively between 1 October 2010 and 31 March 2013. During the first 6 months, a multidisciplinary NST assessment service was implemented. Patient characteristics, clinical condition, referral appropriateness and follow-up were documented prospectively. We compared the frequencies of appropriate referrals, 30-day mortality and mental capacity/consent assessment time spent between the 6 months implementation phase and 2 years following establishment of the assessment service ('established phase'). In total, 309 patients were referred for gastrostomy insertion and 199 (64%) gastrostomies placed. The percentage of appropriate referrals rose from 72% (61/85) during the implementation phase to 87% (194/224) during the established phase (P = 0.002). Thirty-day mortality reduced from 10% (5/52) to 2% (3/147) (P = 0.01), whereas time allocated to assessment of mental capacity and attainment of informed consent rose from mean 3 days (limits of normal variation 0-7) to mean 6 (0-13) days. The introduction of a NST to assess and select patients referred for gastrostomy placement was associated with a rise in the frequency of appropriate referrals and a decrease in 30-day mortality following gastrostomy insertion. Concomitantly, time spent on patient assessment and attainment of informed consent increased. © 2017 The British Dietetic Association Ltd.

  7. Characterization of Severe Arterial Phase Respiratory Motion Artifact on Gadoxetate Disodium-Enhanced MRI - Assessment of Interrater Agreement and Reliability.

    PubMed

    Ringe, Kristina Imeen; Luetkens, Julian A; Fimmers, Rolf; Hammerstingl, Renate Maria; Layer, Günter; Maurer, Martin H; Nähle, Claas Philip; Michalik, Sabine; Reimer, Peter; Schraml, Christina; Schreyer, Andreas G; Stumpp, Patrick; Vogl, Thomas J; Wacker, Frank K; Willinek, Winfried; Kukuk, Guido Mattias

    2018-04-01

     To assess the interrater agreement and reliability of experienced abdominal radiologists in the characterization and grading of arterial phase gadoxetate disodium-related respiratory motion artifact on liver MRI.  This prospective multicenter study was initiated by the working group for abdominal imaging within the German Roentgen Society (DRG), and approved by the local IRB of each participating center. 11 board-certified radiologists independently reviewed 40 gadoxetate disodium-enhanced liver MRI datasets. Motion artifacts in the arterial phase were assessed on a 5-point scale. Interrater agreement and reliability were calculated using the intraclass correlation coefficient (ICC) and Kendall coefficient of concordance (W), with p < 0.05 deemed significant.  The ICC for interrater agreement and reliability were 0.983 (CI 0.973 - 0.990) and 0.985 (CI 0.978 - 0.991), respectively (both p < 0.0001), indicating excellent agreement and reliability. Kendall's W for interrater agreement was 0.865. A severe motion artifact, defined as a mean motion score ≥ 4 in the arterial phase was observed in 12 patients. In these specific cases, a motion score ≥ 4 was assigned by all readers in 75 % (n = 9/12 cases).  Differentiation and grading of arterial phase respiratory motion artifact is possible with a high level of inter-/intrarater agreement and interrater reliability, which is crucial for assessing the incidence of this phenomenon in larger multicenter studies.   · Inter- and intrarater agreement for motion artifact scoring is excellent among experienced readers.. · Interrater reliability for motion artifact scoring is excellent among experienced readers.. · Characterization of severe motion artifacts proved feasible in this multicenter study.. · Ringe KI, Luetkens JA, Fimmers R et al. Characterization of Severe Arterial Phase Respiratory Motion Artifact on Gadoxetate Disodium-Enhanced MRI - Assessment of Interrater Agreement and Reliability. Fortschr Röntgenstr 2017; 190: 341 - 347. © Georg Thieme Verlag KG Stuttgart · New York.

  8. Comparative study of solution-phase and vapor-phase deposition of aminosilanes on silicon dioxide surfaces.

    PubMed

    Yadav, Amrita R; Sriram, Rashmi; Carter, Jared A; Miller, Benjamin L

    2014-02-01

    The uniformity of aminosilane layers typically used for the modification of hydroxyl bearing surfaces such as silicon dioxide is critical for a wide variety of applications, including biosensors. However, in spite of many studies that have been undertaken on surface silanization, there remains a paucity of easy-to-implement deposition methods reproducibly yielding smooth aminosilane monolayers. In this study, solution- and vapor-phase deposition methods for three aminoalkoxysilanes differing in the number of reactive groups (3-aminopropyl triethoxysilane (APTES), 3-aminopropyl methyl diethoxysilane (APMDES) and 3-aminopropyl dimethyl ethoxysilane (APDMES)) were assessed with the aim of identifying methods that yield highly uniform and reproducible silane layers that are resistant to minor procedural variations. Silane film quality was characterized based on measured thickness, hydrophilicity and surface roughness. Additionally, hydrolytic stability of the films was assessed via these thickness and contact angle values following desorption in water. We found that two simple solution-phase methods, an aqueous deposition of APTES and a toluene based deposition of APDMES, yielded high quality silane layers that exhibit comparable characteristics to those deposited via vapor-phase methods. Copyright © 2013 Elsevier B.V. All rights reserved.

  9. Phase IV of Early Restoration | NOAA Gulf Spill Restoration

    Science.gov Websites

    Trustees published the Final Phase IV Early Restoration Plan and Environmental Assessments. The plan habitats. Useful Links: Final Phase IV Early Restoration Plan and Environmental Assessments (pdf, 4.8 MB ) Final Phase IV Early Restoration Plan and Environmental Assessments Executive Summary (pdf, 729 KB

  10. Effects of a Physical Exercise Program (PEP-Aut) on Autistic Children's Stereotyped Behavior, Metabolic and Physical Activity Profiles, Physical Fitness, and Health-Related Quality of Life: A Study Protocol.

    PubMed

    Ferreira, José Pedro; Andrade Toscano, Chrystiane Vasconcelos; Rodrigues, Aristides Machado; Furtado, Guilherme Eustaquio; Barros, Mauro Gomes; Wanderley, Rildo Souza; Carvalho, Humberto Moreira

    2018-01-01

    Physical exercise has shown positive effects on symptomatology and on the reduction of comorbidities in population with autism spectrum disorder (ASD). However, there is still no consensus about the most appropriate exercise intervention model for children with ASD. The physical exercise program for children with autism (PEP-Aut) protocol designed allow us to (i) examine the multivariate associations between ASD symptoms, metabolic profile, physical activity level, physical fitness, and health-related quality of life of children with ASD; (ii) assess the effects of a 40-week exercise program on all these aspects of children with ASD. The impact of the exercise program will be assessed based on the sequence of the two phases. Phase 1 is a 12-week cross-sectional study assessing the symptomatology, metabolic profile, physical fitness and physical activity levels, socioeconomic status profile, and health-related quality of life of participants. This phase is the baseline of the following phase. Phase 2 is a 48-week intervention study with a 40-week intervention with exercise that will take place in a specialized center for children with ASD in the city of Maceió-Alagoas, Brazil. The primary outcomes will be change in the symptomatic profile and the level of physical activity of children. Secondary outcomes will be anthropometric and metabolic profiles, aerobic function, grip strength, socioeconomic status, and health-related quality of life. The study will provide critical information on the efficacy of exercise for children with ASD and help guide design and delivery of future programs.

  11. Clarity, Consistency and Communication: Using Enhanced Dialogue to Create a Course-Based Feedback Strategy

    ERIC Educational Resources Information Center

    Nixon, Sarah; Brooman, Simon; Murphy, Becky; Fearon, Damien

    2017-01-01

    This article examines the outcomes of a study across four discipline areas in order to develop course-based assessment strategies in closer cooperation with students. Second-year students (n = 48) from different disciplines were engaged in two phases of activity-orientated workshops. Phase 1 sought their perceptions of feedback. Phase 2 saw…

  12. An investigation into the protective factors for overweight among low socio-economic status children.

    PubMed

    Boshoff, Kobie; Dollman, Jim; Magarey, Anthea

    2007-08-01

    In light of the current obesity epidemic, this study aimed to expand the knowledge base about the factors involved and the characteristics of children of low socio-economic status (SES) who display healthy behaviours in their eating and physical activity. This project was conducted in two phases: a non-experimental, quantitative design was used in phase one to assess the characteristics of a sample of children in a low SES community. This phase identified children who displayed healthy eating and physical activity behaviours. Phase two used interpretive qualitative methods to investigate the perceptions of these children and their parents about the protective factors involved. Focus groups with children and interviews with their mothers were conducted. In phase one, 45 of 227 children assessed met a priori criteria set for healthy eating and physical activity behaviours. Central themes identified in phase two include: the influence of perceived health benefits; parental and child values regarding healthy eating and physical activity; the sense of enjoyment that children experience; the impact of child preferences and choice; and social influences. The study illustrated the complexity of factors involved in physical activity and healthy eating among children in a low socio-economic community.

  13. Development and initial evaluation of an instrument to assess physiotherapists' clinical reasoning focused on clients' behavior change.

    PubMed

    Elvén, Maria; Hochwälder, Jacek; Dean, Elizabeth; Söderlund, Anne

    2018-05-01

    A systematically developed and evaluated instrument is needed to support investigations of physiotherapists' clinical reasoning integrated with the process of clients' behavior change. This study's aim was to develop an instrument to assess physiotherapy students' and physiotherapists' clinical reasoning focused on clients' activity-related behavior and behavior change, and initiate its evaluation, including feasibility and content validity. The study was conducted in three phases: 1) determination of instrument structure and item generation, based on a model, guidelines for assessing clinical reasoning, and existing measures; 2) cognitive interviews with five physiotherapy students to evaluate item understanding and feasibility; and 3) a Delphi process with 18 experts to evaluate content relevance. Phase 1 resulted in an instrument with four domains: Physiotherapist; Input from client; Functional behavioral analysis; and Strategies for behavior change. The instrument consists of case scenarios followed by items in which key features are identified, prioritized, or interpreted. Phase 2 resulted in revisions of problems and approval of feasibility. Phase 3 demonstrated high level of consensus regarding the instrument's content relevance. This feasible and content-validated instrument shows potential for use in investigations of physiotherapy students' and physiotherapists' clinical reasoning, however continued development and testing are needed.

  14. Evaluating the role of phase I expansion cohorts in oncologic drug development.

    PubMed

    Norris, Robin E; Behtaj, Mohadese; Fu, Pingfu; Dowlati, Afshin

    2017-02-01

    Importance Use of expansion cohorts (EC) in phase I trials is increasing. However, the utility of phase I EC in aiding drug development is unclear. We sought to determine factors associated with the inclusion of EC in phase I studies and the impact of EC on subsequent clinical development. Methods We performed a systematic review of all phase I trials published in the Journal of Clinical Oncology between June 2004 and May 2014. Presence of an EC, number of participants, funding source, class of agent, tumor type, and maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) were identified. Subsequent conduct of phase II studies and FDA approval of the study agent was also assessed. Results We identified 252 phase I studies. An EC was included in 105 studies. Average accrual on EC studies was 47 compared to 31 in studies without EC (p < 0.0001). There was no impact of time on the inclusion of EC. Only 4 % of phase I studies with an EC provided sample size justification. Source of funding had the only significant association with inclusion of EC. Addition of a phase I EC did not impact the phase I MTD/RP2D, subsequent phase II trial, or FDA approval. Conclusion The importance of including an EC in phase I trials is subject to ongoing debate. Our results demonstrated little benefit to including EC in phase I studies. These findings support that innovative design strategies are needed to optimize the utility of EC in phase I studies.

  15. Superfluid Helium Tanker (SFHT) study

    NASA Technical Reports Server (NTRS)

    1988-01-01

    The accomplishments and recommendations of the two-phase Superfluid Helium Tanker (SFHT) study are presented. During the first phase of the study, the emphasis was on defining a comprehensive set of user requirements, establishing SFHT interface parameters and design requirements, and selecting a fluid subsystem design concept. During the second phase, an overall system design concept was constructed based on appropriate analyses and more detailed definition of requirements. Modifications needed to extend the baseline for use with cryogens other than SFHT have been determined, and technology development needs related to the recommended design have been assessed.

  16. Prone positioning reduces severe pushing behavior: three case studies

    PubMed Central

    Fujino, Yuji; Amimoto, Kazu; Sugimoto, Satoshi; Fukata, Kazuhiro; Inoue, Masahide; Takahashi, Hidetoshi; Makita, Shigeru

    2016-01-01

    [Purpose] Pushing behavior is classically described as a disorder of body orientation in the coronal plane. Most interventions for pushing behavior have focused on correcting the deviation in vertical perception. However, pushing behavior seems to involve erroneous movements associated with excessive motor output by the non-paretic limbs and trunk. The present study aimed to inhibit muscular hyper-activity by placing the non-paretic limbs and trunk in the prone position. [Subjects and Methods] The subjects of the present study were 3 acute stroke patients with severe pushing behavior. The study consisted of the following 3 phases: baseline, intervention, and follow-up. In addition to conventional therapy, patients received relaxation therapy in the prone position for 10 minutes a day over 2 days. The severity of pushing behavior was assessed using the scale for contraversive pushing, and truncal balance was evaluated using the trunk control test. These assessments were performed before and after the baseline phase, and after the intervention and follow-up phases. [Results] At the baseline phase, both scores were poor. Both scores improved after the intervention and follow-up phases, and all the patients could sit independently. [Conclusion] Relaxation therapy in the prone position might ameliorate pushing behavior and impaired truncal balance. PMID:27799722

  17. Activities of the National Water-Quality Assessment Program in the upper Snake River Basin, Idaho and western Wyoming, 1991-2001

    USGS Publications Warehouse

    Low, Walton H.

    1997-01-01

    In 1991, the U.S. Geological Survey (USGS) began a full-scale National Water-Quality Assessment (NAWQA) Program. The long-term goals of the NAWQA Program are to describe the status and trends in the water quality of a large part of the Nation's rivers and aquifers and to improve understanding of the primary natural and human factors that affect water-quality conditions. In meeting these goals, the program will produce water-quality, ecological, and geographic information that will be useful to policy makers and managers at the national, State, and local levels. A major component of the program is study-unit investigations, upon which national-level assessment activities are based. The program's 60 study-unit investigations are associated with principal river basins and aquifer systems throughout the Nation. Study units encompass areas from 1,200 to more than 65,000 mi2 (square miles) and incorporate about 60 to 70 percent of the Nation's water use and population served by public water supply. In 1991, the upper Snake River Basin was among the first 20 NAWQA study units selected for implementation. From 1991 to 1995, a high-intensity data-collection phase of the upper Snake River Basin study unit (fig. 1) was implemented and completed. Components of this phase are described in a report by Gilliom and others (1995). In 1997, a low-intensity phase of data collection began, and work continued on data analysis, report writing, and data documentation and archiving activities that began in 1996. Principal data-collection activities during the low-intensity phase will include monitoring of surface-water and ground-water quality, assessment of aquatic biological conditions, and continued compilation of environmental setting information.

  18. Evaluation of statistical designs in phase I expansion cohorts: the Dana-Farber/Harvard Cancer Center experience.

    PubMed

    Dahlberg, Suzanne E; Shapiro, Geoffrey I; Clark, Jeffrey W; Johnson, Bruce E

    2014-07-01

    Phase I trials have traditionally been designed to assess toxicity and establish phase II doses with dose-finding studies and expansion cohorts but are frequently exceeding the traditional sample size to further assess endpoints in specific patient subsets. The scientific objectives of phase I expansion cohorts and their evolving role in the current era of targeted therapies have yet to be systematically examined. Adult therapeutic phase I trials opened within Dana-Farber/Harvard Cancer Center (DF/HCC) from 1988 to 2012 were identified for sample size details. Statistical designs and study objectives of those submitted in 2011 were reviewed for expansion cohort details. Five hundred twenty-two adult therapeutic phase I trials were identified during the 25 years. The average sample size of a phase I study has increased from 33.8 patients to 73.1 patients over that time. The proportion of trials with planned enrollment of 50 or fewer patients dropped from 93.0% during the time period 1988 to 1992 to 46.0% between 2008 and 2012; at the same time, the proportion of trials enrolling 51 to 100 patients and more than 100 patients increased from 5.3% and 1.8%, respectively, to 40.5% and 13.5% (χ(2) test, two-sided P < .001). Sixteen of the 60 trials (26.7%) in 2011 enrolled patients to three or more sub-cohorts in the expansion phase. Sixty percent of studies provided no statistical justification of the sample size, although 91.7% of trials stated response as an objective. Our data suggest that phase I studies have dramatically changed in size and scientific scope within the last decade. Additional studies addressing the implications of this trend on research processes, ethical concerns, and resource burden are needed. © The Author 2014. Published by Oxford University Press. All rights reserved.

  19. Assessing ConnDOT's portland cement concrete testing methods phase II : field trials and implementation.

    DOT National Transportation Integrated Search

    2012-04-01

    This paper presents a description of efforts to disseminate findings from the Phase I study (SPR-2244), provides examples of applied maturity testing and temperature monitoring in Connecticut, reviews several State Highway Agency protocols for using ...

  20. Thermodynamic assessments and inter-relationships between systems involving Al, Am, Ga, Pu, and U

    NASA Astrophysics Data System (ADS)

    Perron, A.; Turchi, P. E. A.; Landa, A.; Oudot, B.; Ravat, B.; Delaunay, F.

    2016-12-01

    A newly developed self-consistent CALPHAD thermodynamic database involving Al, Am, Ga, Pu, and U is presented. A first optimization of the slightly characterized Am-Al and completely unknown Am-Ga phase diagrams is proposed. To this end, phase diagram features as crystal structures, stoichiometric compounds, solubility limits, and melting temperatures have been studied along the U-Al → Pu-Al → Am-Al, and U-Ga → Pu-Ga → Am-Ga series, and the thermodynamic assessments involving Al and Ga alloying are compared. In addition, two distinct optimizations of the Pu-Al phase diagram are proposed to account for the low temperature and Pu-rich region controversy. The previously assessed thermodynamics of the other binary systems (Am-Pu, Am-U, Pu-U, and Al-Ga) is also included in the database and is briefly described in the present work. Finally, predictions on phase stability of ternary and quaternary systems of interest are reported to check the consistency of the database.

  1. Thermodynamic assessments and inter-relationships between systems involving Al, Am, Ga, Pu, and U

    DOE PAGES

    Perron, A.; Turchi, P. E. A.; Landa, A.; ...

    2016-12-01

    We present a newly developed self-consistent CALPHAD thermodynamic database involving Al, Am, Ga, Pu, and U. A first optimization of the slightly characterized Am-Al and completely unknown Am-Ga phase diagrams is proposed. To this end, phase diagram features as crystal structures, stoichiometric compounds, solubility limits, and melting temperatures have been studied along the U-Al → Pu-Al → Am-Al, and U-Ga → Pu-Ga → Am-Ga series, and the thermodynamic assessments involving Al and Ga alloying are compared. In addition, two distinct optimizations of the Pu-Al phase diagram are proposed to account for the low temperature and Pu-rich region controversy. We includedmore » the previously assessed thermodynamics of the other binary systems (Am-Pu, Am-U, Pu-U, and Al-Ga) in the database and is briefly described in the present work. In conclusion, predictions on phase stability of ternary and quaternary systems of interest are reported to check the consistency of the database.« less

  2. Central nervous system antiretroviral efficacy in HIV infection: a qualitative and quantitative review and implications for future research.

    PubMed

    Cysique, Lucette A; Waters, Edward K; Brew, Bruce J

    2011-11-22

    There is conflicting information as to whether antiretroviral drugs with better central nervous system (CNS) penetration (neuroHAART) assist in improving neurocognitive function and suppressing cerebrospinal fluid (CSF) HIV RNA. The current review aims to better synthesise existing literature by using an innovative two-phase review approach (qualitative and quantitative) to overcome methodological differences between studies. Sixteen studies, all observational, were identified using a standard citation search. They fulfilled the following inclusion criteria: conducted in the HAART era; sample size > 10; treatment effect involved more than one antiretroviral and none had a retrospective design. The qualitative phase of review of these studies consisted of (i) a blind assessment rating studies on features such as sample size, statistical methods and definitions of neuroHAART, and (ii) a non-blind assessment of the sensitivity of the neuropsychological methods to HIV-associated neurocognitive disorder (HAND). During quantitative evaluation we assessed the statistical power of studies, which achieved a high rating in the qualitative analysis. The objective of the power analysis was to determine the studies ability to assess their proposed research aims. After studies with at least three limitations were excluded in the qualitative phase, six studies remained. All six found a positive effect of neuroHAART on neurocognitive function or CSF HIV suppression. Of these six studies, only two had statistical power of at least 80%. Studies assessed as using more rigorous methods found that neuroHAART was effective in improving neurocognitive function and decreasing CSF viral load, but only two of those studies were adequately statistically powered. Because all of these studies were observational, they represent a less compelling evidence base than randomised control trials for assessing treatment effect. Therefore, large randomised trials are needed to determine the robustness of any neuroHAART effect. However, such trials must be longitudinal, include the full spectrum of HAND, ideally carefully control for co-morbidities, and be based on optimal neuropsychology methods.

  3. Phase II of the International Study of Asthma and Allergies in Childhood (ISAAC II): rationale and methods.

    PubMed

    Weiland, S K; Björkstén, B; Brunekreef, B; Cookson, W O C; von Mutius, E; Strachan, D P

    2004-09-01

    International comparative studies, investigating whether disease incidence or prevalence rates differ between populations and, if so, which factors explain the observed differences, have made important contributions to the understanding of disease aetiology in many areas. In Phase I of the International Study of Asthma and Allergies in Childhood (ISAAC), the prevalence rates of symptoms of asthma, allergic rhinitis and atopic eczema in 13-14-yr-olds, assessed by standardised questionnaires, were found to differ >20-fold between the 155 study centres around the world. Phase II of ISAAC aims to identify determinants of these differences by studying informative populations. A detailed study protocol was developed for use in community-based random samples of children aged 9-11 yrs. The study modules include standardised questionnaires with detailed questions on the occurrence and severity of symptoms of asthma, allergic rhinitis and atopic eczema, their clinical management, and a broad range of previous and current exposure conditions. In addition, standardised protocols were applied for examination of flexural dermatitis, skin-prick testing, bronchial challenge with hypertonic saline, blood sampling for immunoglobulin E analyses and genotyping, and dust sampling for assessment of indoor exposures to allergens and endotoxin. To date, ISAAC II field work had been completed or started in 30 study centres in 22 countries. The majority of centres are in countries that participated in International Study of Asthma and Allergies in Childhood Phase I and reflect almost the full range of the observed variability in Phase I prevalence rates.

  4. Cutaneous irritancy of an ibuprofen medicated plaster in healthy volunteers.

    PubMed

    Maganji, Manisha; Connolly, Mark P; Bhatt, Aomesh

    2018-04-01

    To assess the irritation and contact sensitization potential of a 200 mg ibuprofen medicated plaster. This double-blind, phase-1 placebo controlled study had two phases; the induction phase to evaluate the irritant potential of continuous application of the plaster, and the challenge phase to assess contact sensitivity (allergy). The cumulative irritancy potential was evaluated using an adaptation of the Shelanski method. Healthy adults (≥18 years of age) (N = 210) were treated simultaneously with one ibuprofen medicated and one placebo plaster applied in a randomized fashion to either the left or right side of the lower back. During the induction phase, plasters were applied on Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 and the final plaster removed on Day 22. At each scheduled visit plasters and applications sites were assessed for degree of adhesion and skin irritation (score of 1 = no irritation to 7 = strong reaction spreading beyond test sites), respectively. The challenge phase followed a two-week washout period. A plaster was applied on Day 36 for 48 h and assessment occurred on Days 38, 39, and 40. The mean cumulative irritation score during the induction phase was lower for the ibuprofen medicated plaster than the placebo plaster (0.32 vs. 1.23, respectively). Three (1.4%) subjects experience a dermal reaction of grade ≥3 for the ibuprofen medicated plaster compared with 27 (12.7%) for the placebo plaster. Following challenge with ibuprofen or placebo plasters, 12 subjects (6.2%) with the ibuprofen medicated plaster and four (2.2%) with the placebo plaster had skin reaction of assessment grade higher than the induction phase. One subject for the ibuprofen and two for the placebo plaster had reactions with grade >2. No subjects showed an increase in sensitization on Day 39 or 40 compared with Day 38. The findings indicate that the both the irritancy and contact sensitization of the ibuprofen medicated plaster is acceptable.

  5. Multiple sclerosis and continence issues: an exploratory study.

    PubMed

    Wollin, Judy; Bennie, Mary; Leech, Christine; Windsor, Carol; Spencer, Nancy

    The study described in this article aimed to identify issues relating to incontinence and assess the impact of referral to a continence adviser on the lives of people with multiple sclerosis (MS). The study design used an in-depth, two-phase anonymous mail survey within a general community as nominated by the participants. Fifty-six people participated in phase 1 and eleven people completed phase 2. The results indicated that incontinence is a problem for the vast majority of participants--people with MS. One-third of the eligible participants took up the option of a consultation, assessment and treatment from a continence nurse. Reasons for not taking up the visit from the continence nurse included 'managing OK', 'didn't think it would help', 'embarrassed' and 'too busy'. Increasing awareness of urinary incontinence in the community is important and education needs to focus on at-risk groups in presenting the range of options available to assist people experiencing incontinence.

  6. A biopsychosocial vignette for case conceptualization in dementia (VIG-Dem): development and pilot study.

    PubMed

    Spector, Aimee; Hebditch, Molly; Stoner, Charlotte R; Gibbor, Luke

    2016-09-01

    The ability to identify biological, social, and psychological issues for people with dementia is an important skill for healthcare professionals. Therefore, valid and reliable measures are needed to assess this ability. This study involves the development of a vignette style measure to capture the extent to which health professionals use "Biopsychosocial" thinking in dementia care (VIG-Dem), based on the framework of the model developed by Spector and Orrell (2010). The development process consisted of Phase 1: Developing and refining the vignettes; Phase 2: Field testing (N = 9), and Phase 3: A pilot study to assess reliability and validity (N = 131). The VIG-Dem, consisting of two vignettes with open-ended questions and a standardized scoring scheme, was developed. Evidence for the good inter-rater reliability, convergent validity, and test-retest reliability were established. The VIG-Dem has good psychometric properties and may provide a useful tool in dementia care research and practice.

  7. Magnetic BiMn-α phase synthesis prediction: First-principles calculation, thermodynamic modeling and nonequilibrium chemical partitioning

    DOE PAGES

    Zhou, S. H.; Liu, C.; Yao, Y. X.; ...

    2016-04-29

    BiMn-α is promising permanent magnet. Due to its peritectic formation feature, there is a synthetic challenge to produce single BiMn-α phase. The objective of this study is to assess driving force for crystalline phase pathways under far-from-equilibrium conditions. First-principles calculations with Hubbard U correction are performed to provide a robust description of the thermodynamic behavior. The energetics associated with various degrees of the chemical partitioning are quantified to predict temperature, magnetic field, and time dependence of the phase selection. By assessing the phase transformation under the influence of the chemical partitioning, temperatures, and cooling rate from our calculations, we suggestmore » that it is possible to synthesize the magnetic BiMn-α compound in a congruent manner by rapid solidification. The external magnetic field enhances the stability of the BiMn-α phase. In conclusion, the compositions of the initial compounds from these highly driven liquids can be far from equilibrium.« less

  8. The objective structured clinical examination revisited for postgraduate trainees in general practice.

    PubMed

    Schoenmakers, Birgitte; Wens, Johan

    2014-03-04

    To investigate if the psychometric qualities of an OSCE consisting of more complex simulated patient encounters remain valid and reliable in the assessment of postgraduate trainees in general practice. In this intervention study without control group, the traditional OSCE was formally replaced by the new, complex version. The study population was composed by all postgraduate trainees (second and third phase) in general practice during the ongoing academic year. Data were handled and collected as part of the formal assessment program. Univariate analyses, the variance of scores and multivariate analyses were performed to assess the test qualities. A total of 340 students participated. Average final scores were slightly higher for third-phase students (t-test, p =0.05). Overall test scores were equally distributed on station level, circuit level and phase level. A multiple regression analysis revealed that test scores were dependent on the stations and circuits, but not on the master phase. In a changing learning environment, assessment and evaluation strategies require reorientation. The reliability and validity of the OSCE remain subject to discussion. In particular, when it comes to content and design, the traditional OSCE might underestimate the performance level of postgraduate trainees in general practice. A reshaping of this OSCE to a more sophisticated design with more complex patient encounters appears to restore the validity of the test results.

  9. Promoting the Quality of Health Research-based News: Introduction of a Tool

    PubMed Central

    Ashoorkhani, Mahnaz; Majdzadeh, Reza; Nedjat, Saharnaz; Gholami, Jaleh

    2017-01-01

    Introduction: While disseminating health research findings to the public, it is very important to present appropriate and accurate information to give the target audience a correct understanding of the subject matter. The objective of this study was to design and psychometrically evaluate a checklist for health journalists to help them prepare news of appropriate accuracy and authenticity. Methods: The study consisted of two phases, checklist design and psychometrics. Literature review and expert opinion were used to extract the items of the checklist in the first phase. In the second phase, to assess content and face validity, the judgment of 38 persons (epidemiologists with a tool production history, editors-in-chief, and health journalists) was used to check the items’ understandability, nonambiguity, relevancy, and clarity. Reliability was assessed by the test–retest method using intra-cluster correlation (ICC) indices in the two phases. Cronbach's alpha was used to assess internal validity of the checklist. Results: Based on the participants’ opinions, the items were reduced from 20 to 14 in number. The items were categorized into the following three domains: (a) items assessing the source of news and its validity, (b) items addressing the presentation of complete and accurate information on research findings, and (c) items which if adhered to lead to the target audiences’ better understanding. The checklist was approved for content and face validity. The reliability of the checklist was assessed in the last stage; the ICC was 1 for 12 items and above 0.8 for the other two. Internal consistency (Cronbach's alpha) was 0.98. Discussion and Conclusions: The resultant indices of the study indicate that the checklist has appropriate validity and reliability. Hence, it can be used by health journalists to develop health research-based news. PMID:29184638

  10. Using heuristic evaluations to assess the safety of health information systems.

    PubMed

    Carvalho, Christopher J; Borycki, Elizabeth M; Kushniruk, Andre W

    2009-01-01

    Health information systems (HISs) are typically seen as a mechanism for reducing medical errors. There is, however, evidence to prove that technology may actually be the cause of errors. As a result, it is crucial to fully test any system prior to its implementation. At present, evidence-based evaluation heuristics do not exist for assessing aspects of interface design that lead to medical errors. A three phase study was conducted to develop evidence-based heuristics for evaluating interfaces. Phase 1 consisted of a systematic review of the literature. In Phase 2 a comprehensive list of 33 evaluation heuristics was developed based on the review that could be used to test for potential technology induced errors. Phase 3 involved applying these healthcare specific heuristics to evaluate a HIS.

  11. The TrialNet Natural History Study of the Development of Type 1 Diabetes: objectives, design, and initial results.

    PubMed

    Mahon, Jeffrey L; Sosenko, Jay M; Rafkin-Mervis, Lisa; Krause-Steinrauf, Heidi; Lachin, John M; Thompson, Clinton; Bingley, Polly J; Bonifacio, Ezio; Palmer, Jerry P; Eisenbarth, George S; Wolfsdorf, Joseph; Skyler, Jay S

    2009-04-01

    TrialNet's goal to test preventions for type 1 diabetes has created an opportunity to gain new insights into the natural history of pre-type 1 diabetes. The TrialNet Natural History Study (NHS) will assess the predictive value of existing and novel risk markers for type 1 diabetes and will find subjects for prevention trials. The NHS is a three-phase, prospective cohort study. In phase 1 (screening), pancreatic autoantibodies (glutamic acid decarboxylase, insulin, ICA-512, and islet cell antibodies) are measured. Phase 2 (baseline risk assessment) includes oral glucose tolerance tests (OGTTs) in antibody-positive subjects and estimation of 5-yr diabetes risks according to the OGTT and number of confirmed positive antibody tests. Phase 3 (follow-up risk assessments) requires OGTTs every 6 months. In phases 2 and 3, samples are collected for future tests of T-lymphocyte function, autoantibody isotypes, RNA gene expression, and proteomics. The primary outcome is diabetes onset. Of 12 636 relatives screened between March 2004 and December 2006, 605 (4.8%) were positive for at least one biochemical antibody. Of these, 322 were confirmed antibody positive and completed phase 2, of whom 296 subjects were given preliminary 5-yr diabetes risks of <25% (n = 132), > or =25% (n = 36), and > or =50% (n = 128) where the latter two categories represent different subjects based on number of confirmed positive antibodies (2, > or =25%; 3 or more, > or =50%) and/or an abnormal OGTT (> or =50%). The NHS is identifying potential prevention trial subjects and is assembling a large cohort that will provide new natural history information about pre-type 1 diabetes. Follow-up to diabetes will help establish the biological significance and clinical value of novel type 1 diabetes risk markers.

  12. Development of scales to assess patients' perception of physicians' cultural competence in health care interactions.

    PubMed

    Ahmed, Rukhsana; Bates, Benjamin R

    2012-07-01

    This study describes the development of scales to measure patients' perception of physicians' cultural competence in health care interactions and thus contributes to promoting awareness of physician-patient intercultural interaction processes. Surveys were administrated to a total of 682 participants. Exploratory factor analyses were employed to assess emergent scales and subscales to develop reliable instruments. The first two phases were devoted to formative research and pilot study. The third phase was devoted to scale development, which resulted in a five-factor solution to measure patient perception of physicians' cultural competence for patient satisfaction.

  13. Reliability of a computer-based system for measuring visual performance skills.

    PubMed

    Erickson, Graham B; Citek, Karl; Cove, Michelle; Wilczek, Jennifer; Linster, Carolyn; Bjarnason, Brendon; Langemo, Nathan

    2011-09-01

    Athletes have demonstrated better visual abilities than nonathletes. A vision assessment for an athlete should include methods to evaluate the quality of visual performance skills in the most appropriate, accurate, and repeatable manner. This study determines the reliability of the visual performance measures assessed with a computer-based system, known as the Nike Sensory Station. One hundred twenty-five subjects (56 men, 69 women), age 18 to 30, completed Phase I of the study. Subjects attended 2 sessions, separated by at least 1 week, in which identical protocols were followed. Subjects completed the following assessments: Visual Clarity, Contrast Sensitivity, Depth Perception, Near-Far Quickness, Target Capture, Perception Span, Eye-Hand Coordination, Go/No Go, and Reaction Time. An additional 36 subjects (20 men, 16 women), age 22 to 35, completed Phase II of the study involving modifications to the equipment, instructions, and protocols from Phase I. Results show no significant change in performance over time on assessments of Visual Clarity, Contrast Sensitivity, Depth Perception, Target Capture, Perception Span, and Reaction Time. Performance did improve over time for Near-Far Quickness, Eye-Hand Coordination, and Go/No Go. The results of this study show that many of the Nike Sensory Station assessments show repeatability and no learning effect over time. The measures that did improve across sessions show an expected learning effect caused by the motor response characteristics being measured. Copyright © 2011 American Optometric Association. Published by Elsevier Inc. All rights reserved.

  14. Assessing misclassification of vaccination status: Implications for studies of the safety of the childhood immunization schedule.

    PubMed

    Daley, Matthew F; Glanz, Jason M; Newcomer, Sophia R; Jackson, Michael L; Groom, Holly C; Lugg, Marlene M; McLean, Huong Q; Klein, Nicola P; Weintraub, Eric S; McNeil, Michael M

    2017-04-04

    To address public concern about the safety of the childhood immunization schedule, the Institute of Medicine recommended observational studies comparing adverse health outcomes of fully vaccinated children to children under-vaccinated due to parental choice. Misclassification of vaccination status could bias such studies. To assess risk of misclassification of vaccination status within the Vaccine Safety Datalink (VSD). A retrospective cohort study was conducted in three phases. In phase 1, electronic health record (EHR) data were used to identify patterns of under-vaccination during the first 24months of life potentially due to parental choice. In phase 2, a random sample of records of under-vaccinated children was manually reviewed. In phase 3, a separate sample of parents were surveyed to assess whether EHR data accurately reflected their child's vaccination status. Phases 1 and 2 were conducted at 6 VSD sites, phase 3 at 1 site. The study cohort included 361,901 children born 2004 through 2012. By 24months of age, 198,249 (54.8%) were fully vaccinated with no delays, 84,698 (23.4%) experienced delays but were fully vaccinated by 24months of age, 4865 (1.3%) received no vaccines, 3789 (1.0%) delayed starting vaccination until ≥4months of age, 4781 (1.3%) had consistent vaccine-limiting (≤2 vaccines per visit), and the remaining 65,519 (18.1%) were missing vaccine series or doses. When a diagnosis code for vaccine refusal was present in EHR data, encounter notes confirmed vaccine refusal as the reason for under-vaccination for nearly 100% of sampled records. Parent surveys confirmed these findings. Parents of under-vaccinated children were more likely to report visiting an alternative medical provider than parents of fully vaccinated children. Specific groups of children, under-vaccinated due to parental choice, can be identified with relatively low likelihood of misclassification of vaccination status using EHR-based vaccine data and diagnosis codes. Copyright © 2017 Elsevier Ltd. All rights reserved.

  15. THERMODYNAMICS AND KINETICS OF PHASE TRANSFORMATIONS IN PLUTONIUM ALLOYS - PART I

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

    Turchi, P A; Kaufman, L; Liu, Z

    2004-08-18

    In this report we investigate order, stability, and phase transformations for a series of actinide-based alloys. The statics and kinetics of precipitation and ordering in this class of alloys are modeled with a scheme that couples fundamental information on the alloy energetics obtained from experimental and assessed thermo-chemical data to the CALPHAD approach commonly used in industry for designing alloys with engineering specificity with the help of the Thermo-Calc software application. The CALPHAD approach is applied to the study of the equilibrium thermodynamic properties of Pu-based alloys, Pu-X, where X=Al, Fe, Ga. The assessment of the equilibrium phase diagrams inmore » the whole range of alloy composition has been performed with the PARROT module of the Thermo-Calc application software. Predictions are made on the low temperature and Pu-rich side of the phase diagrams of Pu-Ga and Pu-Al for which controversy has been noted in the past. The validity of the assessed thermo-chemical database will be discussed by comparing predicted heats of transformation for pure Pu with measured values from differential scanning calorimetry analysis. An overall picture for the stability properties of Pu-Ga and Pu-Al that reconciles the results of past studies carried out on these alloys is proposed. Results on phase stability in the ternary Fe-Ga-Pu and Al-Fe-Pu alloys are discussed. The information collected in this study is then used to model metastability, long-term stability and aging for this class of alloys by coupling Thermo-Calc with DICTRA, a series of modules that allow the analysis of DIffusion Controlled TRAnsformations. Kinetics information is then summarized in so-called TTT (temperature-time-transformations) diagrams for the most relevant phases of actinide alloys. Specifically, results are presented on kinetics of phase transformations associated with the eutectoid-phase decomposition reaction occurring at low temperature, and with the martensitic transformation that takes place at low Ga content in Pu-Ga alloys. Finally, after a summary of the most salient results, suggestions are made for further studies at the micro- and mesoscales.« less

  16. Above, Beyond, and Over the Side rails: Evaluating the New Memorial Emergency Department Fall-Risk-Assessment Tool.

    PubMed

    Scott, Robin A; Oman, Kathleen S; Flarity, Kathleen; Comer, Jennifer L

    2018-03-06

    Patient falls are a significant issue in hospitalized patients and financially costly to hospitals. The Joint Commission requires that patients be assessed for fall risk and interventions in place to mitigate the risk of falls. It is imperative to have a patient population/setting specific fall risk assessment tool to identify patients at risk for falling. The purpose of this study was to evaluate the reliability and validity of the 2013 Memorial ED Fall Risk Assessment tool (MEDFRAT) specifically designed for the ED population. A two-phase prospective design was used for this study. Phase one determined the interrater reliability of the MEDFRAT. Phase two assessed the validity of the MEDFRAT in an emergency department (ED) within a 600-bed academic/teaching institution; Level II Trauma Center with >100,000 annual patient visits. The Memorial ED Fall Risk Assessment Tool was validated in this ED setting. The tool demonstrated positive interrater reliability (k=0.701) and when implemented with a falls prevention strategy and staff education demonstrated a 48% decrease in ED fall rate (0.57 falls/1000 patient visits) post implementation during the study period. The MEDFRAT, an evidenced based ED-specific fall risk tool was implemented on the basis of the risk factors consistently identified in the literature: prior fall history, impaired mobility, altered mental status, altered elimination, and the use of sedative medication. The Memorial ED Fall Risk Assessment Tool demonstrated to be a valid tool for this hospital system. Copyright © 2018 Emergency Nurses Association. Published by Elsevier Inc. All rights reserved.

  17. Water- and air-quality monitoring of the Sweetwater Reservoir Watershed, San Diego County, California-Phase One results, continued, 1999-2001

    USGS Publications Warehouse

    Mendez, Gregory O.; Foreman, William T.; Sidhu, Jagdeep S.; Majewski, Michael S.

    2007-01-01

    In 1998, the U.S. Geological Survey, in cooperation with the Sweetwater Authority, began a study to assess the overall health of the Sweetwater watershed with respect to chemical contamination. The study included regular sampling of air and water at Sweetwater Reservoir for chemical contaminants, including volatile organic compounds, polycyclic aromatic hydrocarbons, pesticides, and major and trace elements. Background water samples were collected at Loveland Reservoir for volatile organic compounds and pesticides. The purpose of this study was to monitor changes in contaminant composition and concentration in the air and water resulting from the construction and operation of State Route 125 near Sweetwater Reservoir. To accomplish this, the study was divided into two phases. Phase One sampling was designed to establish baseline conditions for target compounds in terms of detection frequency and concentration in air and water. Phase Two sampling is planned to continue at the established monitoring sites during and after construction of State Route 125 to assess the chemical impact this roadway alignment project may have on the water quality in the reservoir. In addition to the ongoing data collection, several special studies were initiated to assess the occurrence of specific chemicals of concern, such as low-use pesticides, trace metals, and wastewater compounds. This report describes the study design, and the sampling and analytical methods, and presents the results for the second and third years of the study (October 1999 to September 2001). Data collected during the first year of sampling (October 1998 to September 1999) were published in 2002.

  18. Stressful events and coping related to acute and sub-acute whiplash-associated disorders.

    PubMed

    Pettersson, Susanne; Bring, Annika; Åsenlöf, Pernilla

    2017-03-01

    Purpose To describe daily stressors affecting and coping strategies employed by individuals with whiplash-associated disorders (WAD) immediately to one month (acute) and three to four months (sub-acute) after injury events using a daily coping assessment. Levels of pain, anxiety, depressed mood and activity are also compared between phases. Method A descriptive prospective design with a content analysis approach was used. Participants completed daily coping assessments for one week during both acute and sub-acute phases. Main measure was whiplash-associated disorders-daily coping assessment (WAD-DCA). Results Nine participants used words describing recovery in the sub-acute phase; 31 described stressful events during both phases. Most frequently reported stressors were related to "symptoms", "emotions" and "occupations/studies". These were equally reported during both phases. Cognitive coping strategies were employed more often during the sub-acute phase (p = 0.008). The only behavioral strategy that increased in prevalence over time was the "relaxed" strategy (p = 0.001). Anxiety levels declined over time (p = 0.022). Conclusion The reported stressors were largely uniform across both acute and sub-acute phases; however, the use of cognitive coping strategies increased over time. The WAD-DCA captures individual stressors and coping strategies employed during a vulnerable phase of rehabilitation and can thus provide information that is useful to clinical practice. Implications for rehabilitation The WAD-DCA provides valuable information for clinical practice when employed during early phases of whiplash-associated disorder development. Reported stressors during the acute and sub-acute phases are essentially the same, whereas cognitive coping strategies grow in prevalence over time. Tailored treatments in early phases of whip-lash associated disorders may benefit from strategies aimed at matching patient-specific stressors with contextually adapted coping strategies.

  19. The MARINA Risk Assessment Strategy: A Flexible Strategy for Efficient Information Collection and Risk Assessment of Nanomaterials

    PubMed Central

    Bos, Peter M. J.; Gottardo, Stefania; Scott-Fordsmand, Janeck J.; van Tongeren, Martie; Semenzin, Elena; Fernandes, Teresa F.; Hristozov, Danail; Hund-Rinke, Kerstin; Hunt, Neil; Irfan, Muhammad-Adeel; Landsiedel, Robert; Peijnenburg, Willie J. G. M.; Sánchez Jiménez, Araceli; van Kesteren, Petra C. E.; Oomen, Agnes G.

    2015-01-01

    An engineered nanomaterial (ENM) may actually consist of a population of primary particles, aggregates and agglomerates of various sizes. Furthermore, their physico-chemical characteristics may change during the various life-cycle stages. It will probably not be feasible to test all varieties of all ENMs for possible health and environmental risks. There is therefore a need to further develop the approaches for risk assessment of ENMs. Within the EU FP7 project Managing Risks of Nanoparticles (MARINA) a two-phase risk assessment strategy has been developed. In Phase 1 (Problem framing) a base set of information is considered, relevant exposure scenarios (RESs) are identified and the scope for Phase 2 (Risk assessment) is established. The relevance of an RES is indicated by information on exposure, fate/kinetics and/or hazard; these three domains are included as separate pillars that contain specific tools. Phase 2 consists of an iterative process of risk characterization, identification of data needs and integrated collection and evaluation of data on the three domains, until sufficient information is obtained to conclude on possible risks in a RES. Only data are generated that are considered to be needed for the purpose of risk assessment. A fourth pillar, risk characterization, is defined and it contains risk assessment tools. This strategy describes a flexible and efficient approach for data collection and risk assessment which is essential to ensure safety of ENMs. Further developments are needed to provide guidance and make the MARINA Risk Assessment Strategy operational. Case studies will be needed to refine the strategy. PMID:26633430

  20. The MARINA Risk Assessment Strategy: A Flexible Strategy for Efficient Information Collection and Risk Assessment of Nanomaterials.

    PubMed

    Bos, Peter M J; Gottardo, Stefania; Scott-Fordsmand, Janeck J; van Tongeren, Martie; Semenzin, Elena; Fernandes, Teresa F; Hristozov, Danail; Hund-Rinke, Kerstin; Hunt, Neil; Irfan, Muhammad-Adeel; Landsiedel, Robert; Peijnenburg, Willie J G M; Sánchez Jiménez, Araceli; van Kesteren, Petra C E; Oomen, Agnes G

    2015-11-27

    An engineered nanomaterial (ENM) may actually consist of a population of primary particles, aggregates and agglomerates of various sizes. Furthermore, their physico-chemical characteristics may change during the various life-cycle stages. It will probably not be feasible to test all varieties of all ENMs for possible health and environmental risks. There is therefore a need to further develop the approaches for risk assessment of ENMs. Within the EU FP7 project Managing Risks of Nanoparticles (MARINA) a two-phase risk assessment strategy has been developed. In Phase 1 (Problem framing) a base set of information is considered, relevant exposure scenarios (RESs) are identified and the scope for Phase 2 (Risk assessment) is established. The relevance of an RES is indicated by information on exposure, fate/kinetics and/or hazard; these three domains are included as separate pillars that contain specific tools. Phase 2 consists of an iterative process of risk characterization, identification of data needs and integrated collection and evaluation of data on the three domains, until sufficient information is obtained to conclude on possible risks in a RES. Only data are generated that are considered to be needed for the purpose of risk assessment. A fourth pillar, risk characterization, is defined and it contains risk assessment tools. This strategy describes a flexible and efficient approach for data collection and risk assessment which is essential to ensure safety of ENMs. Further developments are needed to provide guidance and make the MARINA Risk Assessment Strategy operational. Case studies will be needed to refine the strategy.

  1. Translating the semi-structured assessment for drug dependence and alcoholism in the Western Pacific: rationale, study design and reliability of alcohol dependence.

    PubMed

    Quinn, Amity E; Rosen, Rochelle K; McGeary, John E; Amoa, Francine; Kranzler, Henry R; Francazio, Sarah; McGarvey, Stephen T; Swift, Robert M

    2014-01-01

    The aims of this study were to develop a bilingual version of the Semi-Structured Assessment for Drug Dependence and Alcoholism (SSADDA) in English and Samoan and determine the reliability of assessments of alcohol dependence in American Samoa. The study consisted of development and reliability-testing phases. In the development phase, the SSADDA alcohol module was translated and the translation was evaluated through cognitive interviews. In the reliability-testing phase, the bilingual SSADDA was administered to 40 ethnic Samoans, including a sub-sample of 26 individuals who were retested. Cognitive interviews indicated the initial translation was culturally and linguistically appropriate except items pertaining to alcohol tolerance, which were modified to reflect Samoan concepts. SSADDA reliability testing indicated diagnoses of DSM-III-R and DSM-IV alcohol dependence were reliable. Reliability varied by language of administration. The English/Samoan version of the SSADDA is appropriate for the diagnosis of DSM-III-R alcohol dependence, which may be useful in advancing research and public health efforts to address alcohol problems in American Samoa and the Western Pacific. The translation methods may inform researchers translating diagnostic and assessment tools into different languages and cultures. © The Author 2014. Medical Council on Alcohol and Oxford University Press. All rights reserved.

  2. Cortical phase changes in Alzheimer's disease at 7T MRI: a novel imaging marker.

    PubMed

    van Rooden, Sanneke; Versluis, Maarten J; Liem, Michael K; Milles, Julien; Maier, Andrea B; Oleksik, Ania M; Webb, Andrew G; van Buchem, Mark A; van der Grond, Jeroen

    2014-01-01

    Postmortem studies have indicated the potential of high-field magnetic resonance imaging (MRI) to visualize amyloid depositions in the cerebral cortex. The aim of this study is to test this hypothesis in patients with Alzheimer's disease (AD). T2*-weighted MRI was performed in 16 AD patients and 15 control subjects. All magnetic resonance images were scored qualitatively by visual assessment, and quantitatively by measuring phase shifts in the cortical gray matter and hippocampus. Statistical analysis was performed to assess differences between groups. Patients with AD demonstrated an increased phase shift in the cortex in the temporoparietal, frontal, and parietal regions (P < .005), and this was associated with individual Mini-Mental State Examination scores (r = -0.54, P < .05). Increased cortical phase shift in AD patients demonstrated on 7-tesla T2*-weighted MRI is a potential new biomarker for AD, which may reflect amyloid pathology in the early stages. Copyright © 2014 The Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

  3. Developmental Changes in Early Comprehension and Production of Drawings: Evidence From Two Socioeconomic Backgrounds.

    PubMed

    Salsa, Analía M; Vivaldi, Romina

    2017-01-01

    Two studies examined young children's comprehension and production of representational drawings across and within 2 socioeconomic strata (SES). Participants were 130 middle-SES (MSES) and low-SES (LSES) Argentine children, from 30 to 60 months old, given a task with 2 phases, production and comprehension. The production phase assessed free drawing and drawings from simple 3-dimensional objects (model drawing); the comprehension phase assessed children's understanding of an adult's line drawings of the objects. MSES children solved the comprehension phase of the task within the studied age range; representational production emerged first in model drawing (42 months) and later in free drawing (48 months). The same developmental pathway was observed in LSES children but with a clear asynchrony in the age of onset of comprehension and production: Children understood the symbolic nature of drawings at 42 months old and the first representational drawings were found at 60 months old. These results provide empirical evidence that support the crucial influence of social experiences by organizing and constraining graphic development.

  4. Educational interventions targeted at minors in situations of grave social vulnerability and their families

    NASA Astrophysics Data System (ADS)

    de La Caba Collado, Mariangeles; Bartau Rojas, Isabel

    2010-10-01

    The aim of this article is to outline and assess an educational intervention programme targeted at improving the skills of families and the personal and social development of children living in situations of grave social vulnerability. The sample comprised 10 families during the first phase of the intervention and six during the second. The design, intervention and assessment process of this study was carried out in two phases over a period of a year and a half. For both phases, three different groups—of men/fathers, women/mothers and children—were established. Study variables (parenting skills and children's personal and social development) were evaluated before and after the intervention in every group, as well as during the entire process. The results, taking into account the improvements reported by all the participants (social workers, group monitors, fathers, mothers, children) show that inter-professional involvement and coordination at all phases of the intervention is vital in order to achieve small but significant improvements.

  5. Using the analytical hierarchy process to assess the environmental vulnerabilities of basins in Taiwan.

    PubMed

    Chang, Chia-Ling; Chao, Yu-Chi

    2012-05-01

    Every year, Taiwan endures typhoons and earthquakes; these natural hazards often induce landslides and debris flows. Therefore, watershed management strategies must consider the environmental vulnerabilities of local basins. Because many factors affect basin ecosystems, this study applied multiple criteria analysis and the analytical hierarchy process (AHP) to evaluate seven criteria in three phases (geographic phase, hydrologic phase, and societal phase). This study focused on five major basins in Taiwan: the Tan-Shui River Basin, the Ta-Chia River Basin, the Cho-Shui River Basin, the Tseng-Wen River Basin, and the Kao-Ping River Basin. The objectives were a comprehensive examination of the environmental characteristics of these basins and a comprehensive assessment of their environmental vulnerabilities. The results of a survey and AHP analysis showed that landslide area is the most important factor for basin environmental vulnerability. Of all these basins, the Cho-Shui River Basin in central Taiwan has the greatest environmental vulnerability.

  6. Errors in the Extra-Analytical Phases of Clinical Chemistry Laboratory Testing.

    PubMed

    Zemlin, Annalise E

    2018-04-01

    The total testing process consists of various phases from the pre-preanalytical to the post-postanalytical phase, the so-called brain-to-brain loop. With improvements in analytical techniques and efficient quality control programmes, most laboratory errors now occur in the extra-analytical phases. There has been recent interest in these errors with numerous publications highlighting their effect on service delivery, patient care and cost. This interest has led to the formation of various working groups whose mission is to develop standardized quality indicators which can be used to measure the performance of service of these phases. This will eventually lead to the development of external quality assessment schemes to monitor these phases in agreement with ISO15189:2012 recommendations. This review focuses on potential errors in the extra-analytical phases of clinical chemistry laboratory testing, some of the studies performed to assess the severity and impact of these errors and processes that are in place to address these errors. The aim of this review is to highlight the importance of these errors for the requesting clinician.

  7. Perceptions of Student-Teacher Relationships, Self-Efficacy, and Subject Matter Retention in a Secondary Chemistry Course

    ERIC Educational Resources Information Center

    Bechtel, Michael Dean

    2012-01-01

    This was a study of students who had completed a chemistry course taught by one instructor in a large urban high school during 2009-2010. It was conducted in two phases: Phase One assessed self-efficacy, teaching practices, and subject matter retention taken 16 months after course completion. Phase Two consisted of a multiple-choice final exam…

  8. Pre-Service Perspectives on E-Teaching: Assessing E-Teaching Using the EPEC Hierarchy of Conditions for E-Learning/Teaching Competence

    ERIC Educational Resources Information Center

    Sisco, Ashley; Woodcock, Stuart; Eady, Michelle

    2015-01-01

    This article reports on the findings of phase two of a larger study, which examines pre-service teacher experiences engaging with a synchronous (live-time) platform as a part of their training. While phase one focused on pre-service experiences "e-learning" with this synchronous platform (Woodcock, Sisco, & Eady, 2015), phase two…

  9. Pelvic floor dysfunction in the immediate puerperium, and 1 month and 3 months after vaginal or cesarean delivery.

    PubMed

    Colla, Cássia; L Paiva, Luciana; Ferla, Lia; B Trento, Maria J; M P de Vargas, Isadora; A Dos Santos, Bianca; Ferreira, Charles F; L Ramos, José G

    2018-06-07

    To identify and assess postpartum pelvic floor dysfunction (PFD) between vaginal delivery, elective cesarean delivery (ECD), and intrapartum cesarean delivery (ICD). The present prospective observational study included women aged at least 18 years with no history of pelvic surgery or lower urinary tract malformation, and who had not undergone pelvic floor muscle (PFM) training in the preceding 12 months, who underwent delivery at Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil between August 1, 2016, and May 31, 2017. Participants were assessed at 48 hours (phase 1), 1 month (phase 2), and 3 months (phase 3) after delivery. Assessments included the International Consultation on Incontinence Questionnaire, Short Form (ICIQ-SF); the Jorge-Wexner anal incontinence scale; a self-rated visual analog scale for pelvic pain; the pelvic organ prolapse quantification (POP-Q) system; and a PFM perineometer. A total of 227 women were assessed in phase 1 (141 vaginal deliveries; 28 ICDs; and 58 ECDs), 79 in phase 2, and 41 in phase 3. The ICIQ-SF, Jorge-Wexner scale, visual analog scale, and perineometer measurements did not identify significant differences in relation to the type of delivery (P>0.05). The type of delivery was not associated with differences in the short-term development of postpartum PFD. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  10. Assessment of grammar optimizes language tasks for the intracarotid amobarbital procedure.

    PubMed

    Połczyńska, Monika; Kuhn, Taylor; You, S Christine; Walshaw, Patricia; Curtiss, Susan; Bookheimer, Susan

    2017-11-01

    A previous study showed that assessment of language laterality could be improved by adding grammar tests to the recovery phase of the intracarotid amobarbital procedure (IAP) (Połczyńska et al. 2014). The aim of this study was to further investigate the extent to which grammar tests lateralize language function during the recovery phase of the IAP in a larger patient sample. Forty patients with drug-resistant epilepsy (14 females, thirty-two right-handed, mean age 38.5years, SD=10.6) participated in this study. On EEG, 24 patients had seizures originating in the left hemisphere (LH), 13 in the right hemisphere (RH), and 4 demonstrated mixed seizure origin. Thirty participants (75%) had bilateral injections, and ten (25%) had unilateral injections (five RH and five LH). Based on results from the encoding phase, we segregated our study participants to a LH language dominant and a mixed dominance group. In the recovery phase of the IAP, the participants were administered a new grammar test (the CYCLE-N) and a standard language test. We analyzed the laterality index measure and effect sizes in the two tests. In the LH-dominant group, the CYCLE-N generated more profound language deficits in the recovery phase than the standard after injection to either hemisphere (p<0.001). At the same time, the laterality index for the grammar tasks was still higher than for the standard tests. Critically, the CYCLE-N administered in the recovery phase was nearly as effective as the standard tests given during the encoding phase. The results may be significant for individuals with epilepsy undergoing IAP. The grammar tests may be a highly efficient measure for lateralizing language function in the recovery phase. Copyright © 2017 Elsevier Inc. All rights reserved.

  11. Examining the influence of formative assessment on conceptual accumulation and conceptual change

    NASA Astrophysics Data System (ADS)

    Tomita, Miki K.

    This study explored the effect of formative assessment on student achievement in science. Research in science education has shown that students enter science classrooms with previously formed explanatory models of the natural world; these naive "mental models" have a substantial influence on their learning of scientific conceptions. In general, conceptual change describes the pathway from pre-instructional or prior conceptions to a post-instructional or desired conception. Conceptual change involves a fundamental restructuring of a network of concepts rather than fitting new concepts into an existing conceptual network or structure. Research has shown that conceptual change is difficult to promote; for example, students may accumulate multiple conceptions over the course of instruction, including both new misconceptions and more scientifically-sound conceptions. Hellden and Solomon (2004) found that although students tended to evoke the same, less-scientific conceptions over time, they could produce more scientifically-sound conceptions during interviews with appropriate prompting; thus, students undergo conceptual accumulation rather than conceptual change. Students can recall scientifically-sound conceptions they have learned and may use them to reason, but they do so in partnership or hybridization with their less-scientific prior conceptions. Formative assessment, which focuses on providing immediate feedback by acting upon student understanding during the course of instruction, and conceptual change have both been linked to increased student achievement. Formative assessment is an instructional strategy that helps teachers to assess students' current understanding, identify the gap between current understanding and expected understanding, and provide immediate and useful feedback to students on how to close the gap. Formative assessment ranges from formal (e.g. embedded, planned-for interactions between teacher and entire class) to informal (e.g. on-the-fly interactions between teacher and class or student). In this study, the links between formative assessment and conceptual accumulation and conceptual change were explored. Specifically, this study asked: (1) Does formative assessment promote conceptual accumulation, and (2) Does formative assessment promote conceptual change? It was hypothesized that conceptual change-focused formative assessment would foster conceptual change, in addition to supporting conceptual accumulation. It was further hypothesized that all students will show gains in conceptual accumulation as indicated by measures of declarative and procedural knowledge, but that students exposed to conceptual change-focused formative assessment would also show gains in conceptual change as indicated by measures of schematic knowledge or mental models. To research the effect of formative assessment on conceptual accumulation and conceptual change, a small randomized experiment involving 102 middle school students was conducted. In Phase I of the study, 52 6th graders were randomly assigned to a treatment or control group; in Phase II of this study, 50 7th graders were randomly assigned to a treatment or control group. Both the control and experimental groups in both phases were taught about sinking and floating by the same teacher (the author) with identical curriculum materials and activities. In addition, the experimental group received three sets of embedded formative assessments focused on conceptual change around the topic of why things sink and float during the course of instruction. In Phase I of this study, both groups were kept at the same pace through the entire sequence of investigations. The control condition spent more time on some of the more critical FAST lessons, gathering additional data to support the theories the curriculum expected they would develop at a particular juncture but not receiving structured experiences aimed at addressing misconceptions. In Phase II, students in the control condition spent roughly the same time on each FAST lesson as those in the experimental condition (e.g. they finished the sequence of activities earlier because they did not have class sessions devoted to the RLs inserted at critical junctures) but participated in the formal assessments as a block of activities after they finished the FAST investigations and posttest measures. In other words, in addition to replicating Phase I, Phase II included a Reflective Lesson section for the control group after the end of the experiment proper, followed by a post-posttest. Overall, it was found that embedding conceptual change-focused formative assessments in the FAST curriculum significantly influenced conceptual change. It was also found that all students experienced significant gains in terms of their conceptual accumulation, regardless of exposure to the formative assessments. This study connected two previously isolated but theoretically linked educational frameworks: conceptual change and formative assessment. It was found that formative assessments can be used to promote conceptual change. It was also found that conceptual change is different than conceptual accumulation, in that students who show gains on measures of declarative and procedural knowledge do not necessarily show gains on measures of schematic knowledge. (Abstract shortened by UMI.)

  12. [Gastric emptying of a solid-liquid meal in normal subjects: validity of the labeling (99mTc) of chicken liver by a multipuncture technic].

    PubMed

    Hostein, J; Capony, P; Busquet, G; Bost, R; Fournet, J

    1985-04-01

    For gastric emptying studies of a solid-liquid meal by the scintigraphic method, a valid isotope labeling method for each phase of the meal must be obtained. The aim of this study was to validate a simple chicken liver labeling method in normal subjects by multipuncture technic with 99mtechnetium. Labeling according to Meyer's method was chosen as a reference. Simultaneously, a study of the quality of liquid phase labeling by 111indium was done. The labeling process quality for each phase of the meal was assessed: a) in vitro, after incubation of the meal with human gastric juice (n = 12); b) in vivo, after meal ingestion and sequential collection of gastric contents by aspiration (n = 4). Furthermore, in 8 healthy volunteers, gastric emptying curves of the solid and liquid phases of the meal were determined scintigraphically and compared. Our results showed: a) for the solid phase: a good specificity of the marker, which was assessed in vitro and in vivo, after liver labeling with multipuncture technique (89 p. 100 and 92 p. 100 after 180 min, respectively); b) for the liquid phase: a good specificity of the marker in vitro and a poor specificity in vivo (82 p. 100 and 27 p. 100 after 180 min, respectively); c) similar half-gastric emptying times and cumulative percentages for the solid and liquid phases with both liver labeling methods. In conclusion, the multipuncture technique for chicken liver labeling may be used for gastric emptying studies in humans.

  13. Development and validation of Iranian children’s participation assessment scale

    PubMed Central

    Amini, Malek; Hassani Mehraban, Afsoon; Haghni, Hamid; Asgharnezhad, Ali Asghar; Khayatzadeh Mahani, Mohammad

    2016-01-01

    Background: Participation is mostly cultural and familial based, and there is not any assessment scales for evaluating kids’ participation in Iranian context, therefore the purpose of this study was developing children’s participation assessment scale for Iranian children. Methods: Development of this scale occurred in two phases; phase I: planning: following reviewing the literature and adopting and compiling some items of available evaluation tools in the area (such as CAPE, CPQ, CLASS, Life-H) and receiving advice from two expert panels, the preliminary94- item questionnaire was prepared. Phase II: construct: the survey study was carried out on40 children and 21 of their parents to assess the popularity of the activity in Iran; thus, the items of the questionnaire reduced to 92 and after face and content validity, the final version prepared with 71 items. Results: The final 71-item questionnaire was developed in two parent-report and child-report versions. The 71 items based on the literature and expert panels’ advice were categorized in 8 areas of occupation according to Occupational Therapy Practice Framework (ADL, IADL, Play, leisure, social participation, education, work, and sleep/rest). Conclusion: Iranian children’s participation assessment is a useful and culturally relevant tool to measure participation of Iranian children. It can be used in rigorous clinical and population-based research. PMID:27390703

  14. Vehicle's lightweight design vs. electrification from life cycle assessment perspective

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

    Mayyas, Ahmad; Omar, Mohammed; Hayajneh, Mohammed

    Lightwiegh materials and vehicles' electrification are among the most viable and economic solutions to improve fuel ecocnmoy of vehicles and reduce environmental impacts in the operational phase of typical vehicle's life cycle span. This study aims to shed more light on the combined effect of lightweighing and electrification by assessing different lightweight designs and electric powetrians from the environmental perspective using a life cycle analysis coupled with an emphasis on energy expenditures and carbon dioxide emissions. This article discusses the life cycle assessment for several advanced powertrains namely; plug-in hybrid electric vehicles (PHEV), battery electric vehicles (BEV) and hybrid electricmore » vehicles (HEV) relative to the conventional gasoline operated internal combustion engine based power train vehicles. The main focus will be on the energy greenhouse gas emissions (GHG) in the material extraction and resources phase, manufacturing phase and use phase (operation and maintenance). While most of the current studies focus on the use phase that does not reflect the correct environmental impacts associated with advanced powertrains, thus the presented text applies a holistic LCA approach that covers pre-manufacturing, manufacturing, operational and end-of-life phases, plus another indirect phase to account for fuel extraction, refining and transportation to the end-users or customers. Based on the LCA emissions results, one may infer that environmental policies that reduce emissions rates from the electricity sector can mitigate this effect without completely eliminating it. Interestingly, the analysis show that lightweight vehicles with internal combustion engines have less impacts on the environment as a direct result of upstream emissions associated with electricity generation in United States. This scenario can differ in other countries with higher renewable and sustainable energy generated electric powers.« less

  15. Vehicle's lightweight design vs. electrification from life cycle assessment perspective

    DOE PAGES

    Mayyas, Ahmad; Omar, Mohammed; Hayajneh, Mohammed; ...

    2017-08-17

    Lightwiegh materials and vehicles' electrification are among the most viable and economic solutions to improve fuel ecocnmoy of vehicles and reduce environmental impacts in the operational phase of typical vehicle's life cycle span. This study aims to shed more light on the combined effect of lightweighing and electrification by assessing different lightweight designs and electric powetrians from the environmental perspective using a life cycle analysis coupled with an emphasis on energy expenditures and carbon dioxide emissions. This article discusses the life cycle assessment for several advanced powertrains namely; plug-in hybrid electric vehicles (PHEV), battery electric vehicles (BEV) and hybrid electricmore » vehicles (HEV) relative to the conventional gasoline operated internal combustion engine based power train vehicles. The main focus will be on the energy greenhouse gas emissions (GHG) in the material extraction and resources phase, manufacturing phase and use phase (operation and maintenance). While most of the current studies focus on the use phase that does not reflect the correct environmental impacts associated with advanced powertrains, thus the presented text applies a holistic LCA approach that covers pre-manufacturing, manufacturing, operational and end-of-life phases, plus another indirect phase to account for fuel extraction, refining and transportation to the end-users or customers. Based on the LCA emissions results, one may infer that environmental policies that reduce emissions rates from the electricity sector can mitigate this effect without completely eliminating it. Interestingly, the analysis show that lightweight vehicles with internal combustion engines have less impacts on the environment as a direct result of upstream emissions associated with electricity generation in United States. This scenario can differ in other countries with higher renewable and sustainable energy generated electric powers.« less

  16. CRITICAL ANALYSIS OF THE MATHEMATICAL RELATIONSHIPS AND COMPREHENSIVENESS OF LIFE CYCLE IMPACT ASSESSMENT APPROACHES

    EPA Science Inventory

    The impact assessment phase of Life Cycle Assessment (LCA) has received much criticism due to lack of consistency. ISO 14042 requires selection of impact categories that “reflect a comprehensive set of environmental issues” related to the system being studied, especi...

  17. Characterisation of Asphalt Concrete Using Nanoindentation

    PubMed Central

    Barbhuiya, Salim; Caracciolo, Benjamin

    2017-01-01

    In this study, nanoindentation was conducted to extract the load-displacement behaviour and the nanomechanical properties of asphalt concrete across the mastic, matrix, and aggregate phases. Further, the performance of hydrated lime as an additive was assessed across the three phases. The hydrated lime containing samples have greater resistance to deformation in the mastic and matrix phases, in particular, the mastic. There is strong evidence suggesting that hydrated lime has the most potent effect on the mastic phase, with significant increase in hardness and stiffness. PMID:28773181

  18. Multimorbidity in primary care in Portugal (MM-PT): a cross-sectional three-phase observational study protocol

    PubMed Central

    Prazeres, Filipe; Santiago, Luiz

    2014-01-01

    Introduction Multimorbidity is defined as the co-occurrence of more than one chronic disease in one person without assigning an index disease. This rapidly increasing phenomenon markedly influences patients’ overall health, has major implications for effective provision of healthcare services and has a significant economic toll on individuals and society. Since Portugal is a country with a growing ageing population, a better understanding of the role of multimorbidity should be assessed. The aim of this study is to further the knowledge of the epidemiological factors associated with multimorbidity in Portugal, chiefly its prevalence and the health and social implications. Methods and analysis This study protocol describes a primary care nationwide three-phase study. The first phase is drawn to access the prevalence and patterns of multimorbidity. In the second phase, individual parameters are assessed, such as patients’ health-related quality of life, perceived family support and unmet health needs of patients with multimorbidity. The third and last phase of this study aims to characterise general practitioners’ knowledge, awareness and practices related to multimorbidity management. Ethics and dissemination The study will be conducted in accordance with the principles expressed in the Declaration of Helsinki. It has full approval from the Ethics Committee of the Faculty of Health Sciences, University of Beira Interior, and the Ethics Committee of the Central Health Region of Portugal. Study results will be published in peer-reviewed journals and presented at national and international conferences. PMID:24531449

  19. Organisational justice and markers of inflammation: the Whitehall II study.

    PubMed

    Elovainio, Marko; Ferrie, Jane E; Singh-Manoux, Archana; Gimeno, David; De Vogli, Roberto; Shipley, Martin; Vahtera, Jussi; Brunner, Eric; Marmot, Michael G; Kivimäki, Mika

    2010-02-01

    Low organisational justice has been shown to be associated with increased risk of various health problems, but the underlying mechanisms remain unclear. We tested whether organisational injustice contributes to chronic inflammation in a population of middle-aged men and women. This prospective cohort study uses data from 3205 men and 1204 women aged 35-55 years at entry into the Whitehall II study (phase 1, 1985-1988). Organisational justice perceptions were assessed at phase 1 and phase 2 (1989-1990) and circulating inflammatory markers C-reactive protein (CRP) and interleukin (IL)-6 at phase 3 (1991-1993) and phase 7 (2003-2004). In men, low organisational justice was associated with increased CRP levels at both follow-ups (phase 3 and 7) and increased IL-6 at the second follow-up (phase 7). The long term (phase 7) associations were largely independent of covariates, such as age, employment grade, body mass index and depressive symptoms. In women, no relationship was found between organisational justice and CRP or IL-6. This study suggests that organisational injustice is associated with increased long-term levels of inflammatory markers among men.

  20. An emergency department registration kiosk can increase HIV screening in high risk patients.

    PubMed

    Hsieh, Yu-Hsiang; Gauvey-Kern, Megan; Peterson, Stephen; Woodfield, Alonzo; Deruggiero, Katherine; Gaydos, Charlotte A; Rothman, Richard E

    2014-12-01

    We evaluated the feasibility and the patient acceptability of integrating a kiosk into routine emergency department (ED) practice for offering HIV testing. The work was conducted in four phases: phase 1 was a baseline, in which external testing staff offered testing at the bedside; phase 2 was a pilot assessment of a prototype kiosk; phase 3 was a pilot implementation and phase 4 was the full implementation with automated login. Feasibility was assessed by the proportion of offering HIV tests, acceptance, completion and result reporting. During the study period, the number of ED patients and eligible patients for screening were similar in the three main phases. However, the number and proportion of patients offered testing of those eligible for screening increased significantly from phase 1 (32%) to phase 3 (37%) and phase 4 (40%). There were slightly higher prevalences of newly diagnosed HIV with kiosk versus bedside testing (phase 1, 0%; phase 3, 0.2%; phase 4, 0.5%). Compared to patients tested at the bedside, patients tested via the kiosk were significantly younger, more likely to be female, to be black, and to report high risk behaviours. ED-based HIV screening via a registration-based kiosk was feasible, yielded similar proportions of testing, and increased the proportion of engagement of higher-risk patients in testing. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  1. Exploring the Health Education Needs of Young People.

    ERIC Educational Resources Information Center

    Devine, Marion; Mapp, Jacqueline

    This document reports on a 2-year study to determine the health education needs of young people in Scotland and to collaborate with teachers to improve the delivery of health education in relation to specific issues. The study was in two phases. Phase 1 assessed the needs of pupils according to the views of the pupils and adults, their needs based…

  2. Contextualizing and assessing the social capital of seniors in congregate housing residences: study design and methods

    PubMed Central

    Moore, Spencer; Shiell, Alan; Haines, Valerie; Riley, Therese; Collier, Carrie

    2005-01-01

    Background This article discusses the study design and methods used to contextualize and assess the social capital of seniors living in congregate housing residences in Calgary, Alberta. The project is being funded as a pilot project under the Institute of Aging, Canadian Institutes for Health Research. Design/Methods Working with seniors living in 5 congregate housing residencies in Calgary, the project uses a mixed method approach to develop grounded measures of the social capital of seniors. The project integrates both qualitative and quantitative methods in a 3-phase research design: 1) qualitative, 2) quantitative, and 3) qualitative. Phase 1 uses gender-specific focus groups; phase 2 involves the administration of individual surveys that include a social network module; and phase 3 uses anamolous-case interviews. Not only does the study design allow us to develop grounded measures of social capital but it also permits us to test how well the three methods work separately, and how well they fit together to achieve project goals. This article describes the selection of the study population, the multiple methods used in the research and a brief discussion of our conceptualization and measurement of social capital. PMID:15836784

  3. Validity and reliability of a modified english version of the physical activity questionnaire for adolescents.

    PubMed

    Aggio, Daniel; Fairclough, Stuart; Knowles, Zoe; Graves, Lee

    2016-01-01

    Adaptation of physical activity self-report questionnaires is sometimes required to reflect the activity behaviours of diverse populations. The processes used to modify self-report questionnaires though are typically underreported. This two-phased study used a formative approach to investigate the validity and reliability of the Physical Activity Questionnaire for Adolescents (PAQ-A) in English youth. Phase one examined test content and response process validity and subsequently informed a modified version of the PAQ-A. Phase two assessed the validity and reliability of the modified PAQ-A. In phase one, focus groups (n = 5) were conducted with adolescents (n = 20) to investigate test content and response processes of the original PAQ-A. Based on evidence gathered in phase one, a modified version of the questionnaire was administered to participants (n = 169, 14.5 ± 1.7 years) in phase two. Internal consistency and test-retest reliability were assessed using Cronbach's alpha and intra-class correlations, respectively. Spearman correlations were used to assess associations between modified PAQ-A scores and accelerometer-derived physical activity, self-reported fitness and physical activity self-efficacy. Phase one revealed that the original PAQ-A was unrepresentative for English youth and that item comprehension varied. Contextual and population/cultural-specific modifications were made to the PAQ-A for use in the subsequent phase. In phase two, modified PAQ-A scores had acceptable internal consistency (α = 0.72) and test-retest reliability (ICC = 0.78). Modified PAQ-A scores were significantly associated with objectively assessed moderate-to-vigorous physical activity (r = 0.39), total physical activity (r = 0.42), self-reported fitness (r = 0.35), and physical activity self-efficacy (r = 0.32) (p ≤ 0.01). The modified PAQ-A had acceptable internal consistency and test-retest reliability. Modified PAQ-A scores displayed weak-to-moderate correlations with objectively measured physical activity, self-reported fitness, and self-efficacy providing evidence of satisfactory criterion and construct validity, respectively. Further testing with more diverse English samples is recommended to provide a more complete assessment of the tool.

  4. The impact of Phase 1 of the Silver Line on the Northern Virginia transportation system.

    DOT National Transportation Integrated Search

    2017-05-01

    The purpose of this study was to assess the impact of Phase 1 of the Washington Metropolitan Area Transit Authoritys Silver Line on the broad regional transportation system, and specifically on the road network operated by the Virginia Department ...

  5. Life cycle assessment of second generation (2G) and third generation (3G) mobile phone networks.

    PubMed

    Scharnhorst, Wolfram; Hilty, Lorenz M; Jolliet, Olivier

    2006-07-01

    The environmental performance of presently operated GSM and UMTS networks was analysed concentrating on the environmental effects of the End-of-Life (EOL) phase using the Life Cycle Assessment (LCA) method. The study was performed based on comprehensive life cycle inventory and life cycle modelling. The environmental effects were quantified using the IMPACT2002+ method. Based on technological forecasts, the environmental effects of forthcoming mobile telephone networks were approximated. The results indicate that a parallel operation of GSM and UMTS networks is environmentally detrimental and the transition phase should be kept as short as possible. The use phase (i.e. the operation) of the radio network components account for a large fraction of the total environmental impact. In particular, there is a need to lower the energy consumption of those network components. Seen in relation to each other, UMTS networks provide an environmentally more efficient mobile communication technology than GSM networks. In assessing the EOL phase, recycling the electronic scrap of mobile phone networks was shown to have clear environmental benefits. Under the present conditions, material recycling could help lower the environmental impact of the production phase by up to 50%.

  6. Effects of a Physical Exercise Program (PEP-Aut) on Autistic Children’s Stereotyped Behavior, Metabolic and Physical Activity Profiles, Physical Fitness, and Health-Related Quality of Life: A Study Protocol

    PubMed Central

    Ferreira, José Pedro; Andrade Toscano, Chrystiane Vasconcelos; Rodrigues, Aristides Machado; Furtado, Guilherme Eustaquio; Barros, Mauro Gomes; Wanderley, Rildo Souza; Carvalho, Humberto Moreira

    2018-01-01

    Physical exercise has shown positive effects on symptomatology and on the reduction of comorbidities in population with autism spectrum disorder (ASD). However, there is still no consensus about the most appropriate exercise intervention model for children with ASD. The physical exercise program for children with autism (PEP-Aut) protocol designed allow us to (i) examine the multivariate associations between ASD symptoms, metabolic profile, physical activity level, physical fitness, and health-related quality of life of children with ASD; (ii) assess the effects of a 40-week exercise program on all these aspects of children with ASD. The impact of the exercise program will be assessed based on the sequence of the two phases. Phase 1 is a 12-week cross-sectional study assessing the symptomatology, metabolic profile, physical fitness and physical activity levels, socioeconomic status profile, and health-related quality of life of participants. This phase is the baseline of the following phase. Phase 2 is a 48-week intervention study with a 40-week intervention with exercise that will take place in a specialized center for children with ASD in the city of Maceió-Alagoas, Brazil. The primary outcomes will be change in the symptomatic profile and the level of physical activity of children. Secondary outcomes will be anthropometric and metabolic profiles, aerobic function, grip strength, socioeconomic status, and health-related quality of life. The study will provide critical information on the efficacy of exercise for children with ASD and help guide design and delivery of future programs. PMID:29552551

  7. Towards non-invasive 3D hepatotoxicity assays with optical coherence phase microscopy

    NASA Astrophysics Data System (ADS)

    Nelson, Leonard J.; Koulovasilopoulos, Andreas; Treskes, Philipp; Hayes, Peter C.; Plevris, John N.; Bagnaninchi, Pierre O.

    2015-03-01

    Three-dimensional tissue-engineered models are increasingly recognised as more physiologically-relevant than standard 2D cell culture for pre-clinical drug toxicity testing. However, many types of conventional toxicity assays are incompatible with dense 3D tissues. This study investigated the use of optical coherence phase microscopy (OCPM) as a novel approach to assess cell death in 3D tissue culture. For 3D micro-spheroid formation Human hepatic C3A cells were encapsulated in hyaluronic acid gels and cultured in 100μl MEME/10%FBS in 96-well plates. After spheroid formation the 3D liver constructs were exposed to acetaminophen on culture day 8. Acetaminophen hepatotoxicity in 3D cultures was evaluated using standard biochemical assays. An inverted OCPM in common path configuration was developed with a Callisto OCT engine (Thorlabs), centred at 930nm and a custom scanning head. Intensity data were used to perform in-depth microstructural imaging. In addition, phase fluctuations were measured by collecting several successive B scans at the same location, and statistics on the first time derivative of the phase, i.e. time fluctuations, were analysed over the acquisition time interval to retrieve overall cell viability. OCPM intensity (cell cluster size) and phase fluctuation statistics were directly compared with biochemical assays. In this study, we investigated optical coherence phase tomography to assess cell death in a 3d liver model after exposure to a prototypical hepatotoxin, acetaminophen. We showed that OCPM has the potential to assess noninvasively and label-free drug toxicity in 3D tissue models.

  8. Robotic kidney transplantation with regional hypothermia: evolution of a novel procedure utilizing the IDEAL guidelines (IDEAL phase 0 and 1).

    PubMed

    Menon, Mani; Abaza, Ronney; Sood, Akshay; Ahlawat, Rajesh; Ghani, Khurshid R; Jeong, Wooju; Kher, Vijay; Kumar, Ramesh K; Bhandari, Mahendra

    2014-05-01

    Surgical innovation is essential for progress of surgical science, but its implementation comes with potential harms during the learning phase. The Balliol Collaboration has recommended a set of guidelines (Innovation, Development, Exploration, Assessment, Long-term study [IDEAL]) that permit innovation while minimizing complications. To utilize the IDEAL model of surgical innovation in the development of a novel surgical technique, robotic kidney transplantation (RKT) with regional hypothermia, and describe the process of discovery and development. Phase 0 (simulation) studies included the establishment of techniques for pelvic cooling, graft placement in a robotic prostatectomy model, and simulation of the RKT procedure in a cadaveric model. Phase 1 (innovation) studies began in January 2013 and involved treatment of a highly selective small group of patients (n=7), using the principles utilized in the phase 0 studies, at a tertiary referral center. IDEAL model implementation in the development of RKT with regional hypothermia. For phase 0 studies, the outcomes evaluated included pelvic and body temperature measurements, and technical feasibility assessment. The primary outcome during phase 1 was post-transplant graft function. Other outcomes measured were operative and ischemic times, perioperative complications, and intracorporeal graft surface temperature. Phase 0 (simulation phase): Pelvic cooling to 15-20(o)C was achieved reproducibly. Using the surgical approach developed for robotic radical prostatectomy, vascular and ureterovesical anastomoses could be done without redocking the robot. Phase 1 (innovation phase): All patients underwent live-donor RKT in the lithotomy position. All grafts functioned immediately. Mean console, anastomotic, and warm ischemia times were 154 min, 29 min, and 2 min, respectively. One patient was re-explored on postoperative day 1. Adherence to the IDEAL guidelines put forth by the Balliol Collaboration provided a practical framework for the establishment of a novel surgical procedure, RKT with regional hypothermia, without exposing the initial patients to unacceptable risk. The IDEAL model allows safe introduction of new surgical techniques without compromising patient outcomes. Copyright © 2013 European Association of Urology. Published by Elsevier B.V. All rights reserved.

  9. A Community Needs Assessment for the Development of an Interprofessional Palliative Care Training Curriculum.

    PubMed

    Coats, Heather; Paganelli, Tia; Starks, Helene; Lindhorst, Taryn; Starks Acosta, Anne; Mauksch, Larry; Doorenbos, Ardith

    2017-03-01

    There is a known shortage of trained palliative care professionals, and an even greater shortage of professionals who have been trained through interprofessional curricula. As part of an institutional Palliative Care Training Center grant, a core team of interprofessional palliative care academic faculty and staff completed a state-wide palliative care educational assessment to determine the needs for an interprofessional palliative care training program. The purpose of this article is to describe the process and results of our community needs assessment of interprofessional palliative care educational needs in Washington state. We approached the needs assessment through a cross-sectional descriptive design by using mixed-method inquiry. Each phase incorporated a variety of settings and subjects. The assessment incorporated multiple phases with diverse methodological approaches: a preparatory phase-identifying key informants; Phase I-key informant interviews; Phase II-survey; and Phase III-steering committee endorsement. The multiple phases of the needs assessment helped create a conceptual framework for the Palliative Care Training Center and developed an interprofessional palliative care curriculum. The input from key informants at multiple phases also allowed us to define priority needs and to refine an interprofessional palliative care curriculum. This curriculum will provide an interprofessional palliative care educational program that crosses disciplinary boundaries to integrate knowledge that is beneficial for all palliative care clinicians. The input from a range of palliative care clinicians and professionals at every phase of the needs assessment was critical for creating an interprofessional palliative care curriculum.

  10. Vega roll and attitude control system algorithms trade-off study

    NASA Astrophysics Data System (ADS)

    Paulino, N.; Cuciniello, G.; Cruciani, I.; Corraro, F.; Spallotta, D.; Nebula, F.

    2013-12-01

    This paper describes the trade-off study for the selection of the most suitable algorithms for the Roll and Attitude Control System (RACS) within the FPS-A program, aimed at developing the new Flight Program Software of VEGA Launcher. Two algorithms were analyzed: Switching Lines (SL) and Quaternion Feedback Regulation. Using a development simulation tool that models two critical flight phases (Long Coasting Phase (LCP) and Payload Release (PLR) Phase), both algorithms were assessed with Monte Carlo batch simulations for both of the phases. The statistical outcomes of the results demonstrate a 100 percent success rate for Quaternion Feedback Regulation, and support the choice of this method.

  11. BIOLOGICAL RESPONSES OF THE SEA URCHIN, ARBACIA PUNTULATA, TO LEAD CONTAMINATION FOR AN ESTUARINE ECOLOGICAL RISK ASSESSMENT

    EPA Science Inventory

    An estuarine ecological risk assessment for the Portsmouth Naval Shipyard (PNS) Kittery, ME, was conducted utilizing the U.S. EPA's Framework for Ecological Risk Assessment (ERA). As part of the analysis phase of the ERA, laboratory studies were conducted to develop quantitative ...

  12. Using the Dynamic Model to Identify Stages of Teacher Skills in Assessment

    ERIC Educational Resources Information Center

    Christoforidou, Margarita; Xirafidou, Elisavet

    2014-01-01

    The article presents the results of two cross-sectional studies that investigate teachers' skills in using various techniques of assessment in mathematics by taking into account the four phases of assessment. The five dimensions of the dynamic model are also taken into account in proposing a framework for measuring teacher skills in assessment.…

  13. Reproducibility patterns of multiple rapid swallows during high resolution esophageal manometry provide insights into esophageal pathophysiology.

    PubMed

    Price, L H; Li, Y; Patel, A; Gyawali, C Prakash

    2014-05-01

    Multiple rapid swallows (MRS) during esophageal high resolution manometry (HRM) assess esophageal neuromuscular integrity by evaluating postdeglutitive inhibition and rebound contraction, but most reports performed only a single MRS sequence. We assessed patterns of MRS reproducibility during clinical HRM in comparison to a normal cohort. Consecutive clinical HRM studies were included if two separate MRS sequences (four to six rapid swallows ≤4 s apart) were successfully performed. Chicago Classification diagnoses were identified; contraction wave abnormalities were additionally recorded. MRS-induced inhibition (contraction ≤3 cm during inhibition phase) and rebound contraction was assessed, and findings compared to 18 controls (28.0 ± 0.7 year, 50.0% female). Reproducibility consisted of similar inhibition and contraction responses with both sequences; discordance was segregated into inhibition and contraction phases. Multiple rapid swallows were successfully performed in 89.3% patients and all controls; 225 subjects (56.2 ± 0.9 year, 62.7% female) met study inclusion criteria. Multiple rapid swallows were reproducible in 76.9% patients and 94.4% controls (inhibition phase: 88.0% vs 94.4%, contraction phase 86.7% vs 100%, respectively, p = ns). A gradient of reproducibility was noted, highest in well-developed motor disorders (achalasia spectrum, hypermotility disorders, and aperistalsis, 91.7-100%, p = ns compared to controls); and lower in lesser motor disorders (contraction wave abnormalities, esophageal body hypomotility) or normal studies (62.2-70.8%, p < 0.0001 compared to well-developed motor disorders). Inhibition phase was most discordant in contraction wave abnormalities, while contraction phase was most discordant when studies were designated normal. Multiple rapid swallows are highly reproducible, especially in well-developed motor disorders, and complement the standard wet swallow manometry protocol. © 2014 John Wiley & Sons Ltd.

  14. An international study to revise the EORTC questionnaire for assessing quality of life in lung cancer patients.

    PubMed

    Koller, M; Hjermstad, M J; Tomaszewski, K A; Tomaszewska, I M; Hornslien, K; Harle, A; Arraras, J I; Morag, O; Pompili, C; Ioannidis, G; Georgiou, M; Navarra, C; Chie, W-C; Johnson, C D; Himpel, A; Schulz, C; Bohrer, T; Janssens, A; Kulis, D; Bottomley, A

    2017-11-01

    The European Organization for Research and Treatment of Cancer (EORTC) QLQ-LC13 was the first module to be used in conjunction with the core questionnaire, the QLQ-C30. Since the publication of the LC13 in 1994, major advances have occurred in the treatment of lung cancer. Given this, an update of the EORTC QLQ-LC13 was undertaken. The study followed phases I to III of the EORTC Module Development Guidelines. Phase I generated relevant quality-of-life issues using a mix of sources including the involvement of 108 lung cancer patients. Phase II transformed issues into questionnaire items. In an international multicenter study (phase III), patients completed both the EORTC QLQ-C30 and the 48-item provisional lung cancer module generated in phases I and II. Patients rated each of the items regarding relevance, comprehensibility, and acceptance. Patient ratings were assessed against a set of prespecified statistical criteria. Descriptive statistics and basic psychometric analyses were carried out. The phase III study enrolled 200 patients with histologically confirmed lung cancer from 12 centers in nine countries (Cyprus, Germany, Italy, Israel, Spain, Norway, Poland, Taiwan, and the UK). Mean age was 64 years (39 - 91), 59% of the patients were male, 82% had non-small-cell lung cancer, and 56% were treated with palliative intent. Twenty-nine of the 48 questions met the criteria for inclusion. The resulting module with 29 questions, thus currently named EORTC QLQ-LC29, retained 12 of the 13 original items, supplemented with 17 items that primarily assess treatment side-effects of traditional and newer therapies. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  15. ROC curves in clinical chemistry: uses, misuses, and possible solutions.

    PubMed

    Obuchowski, Nancy A; Lieber, Michael L; Wians, Frank H

    2004-07-01

    ROC curves have become the standard for describing and comparing the accuracy of diagnostic tests. Not surprisingly, ROC curves are used often by clinical chemists. Our aims were to observe how the accuracy of clinical laboratory diagnostic tests is assessed, compared, and reported in the literature; to identify common problems with the use of ROC curves; and to offer some possible solutions. We reviewed every original work using ROC curves and published in Clinical Chemistry in 2001 or 2002. For each article we recorded phase of the research, prospective or retrospective design, sample size, presence/absence of confidence intervals (CIs), nature of the statistical analysis, and major analysis problems. Of 58 articles, 31% were phase I (exploratory), 50% were phase II (challenge), and 19% were phase III (advanced) studies. The studies increased in sample size from phase I to III and showed a progression in the use of prospective designs. Most phase I studies were powered to assess diagnostic tests with ROC areas >/=0.70. Thirty-eight percent of studies failed to include CIs for diagnostic test accuracy or the CIs were constructed inappropriately. Thirty-three percent of studies provided insufficient analysis for comparing diagnostic tests. Other problems included dichotomization of the gold standard scale and inappropriate analysis of the equivalence of two diagnostic tests. We identify available software and make some suggestions for sample size determination, testing for equivalence in diagnostic accuracy, and alternatives to a dichotomous classification of a continuous-scale gold standard. More methodologic research is needed in areas specific to clinical chemistry.

  16. A Science Plan for a Comprehensive Regional Assessment of the Atlantic Coastal Plain Aquifer System in Maryland

    USGS Publications Warehouse

    Shedlock, Robert J.; Bolton, David W.; Cleaves, Emery T.; Gerhart, James M.; Nardi, Mark R.

    2007-01-01

    The Maryland Coastal Plain region is, at present, largely dependent upon ground water for its water supply. Decades of increasing pumpage have caused ground-water levels in parts of the Maryland Coastal Plain to decline by as much as 2 feet per year in some areas of southern Maryland. Continued declines at this rate could affect the long-term sustainability of ground-water resources in Maryland's heavily populated Coastal Plain communities and the agricultural industry of the Eastern Shore. In response to a recommendation in 2004 by the Advisory Committee on the Management and Protection of the State's Water Resources, the Maryland Geological Survey and the U.S. Geological Survey have developed a science plan for a comprehensive assessment that will provide new scientific information and new data management and analysis tools for the State to use in allocating ground water in the Coastal Plain. The comprehensive assessment has five goals aimed at improving the current information and tools used to understand the resource potential of the aquifer system: (1) document the geologic and hydrologic characteristics of the aquifer system in the Maryland Coastal Plain and appropriate areas of adjacent states; (2) conduct detailed studies of the regional ground-water-flow system and water budget for the aquifer system; (3) improve documentation of patterns of water quality in all Coastal Plain aquifers, including the distribution of saltwater; (4) enhance ground-water-level, streamflow, and water-quality-monitoring networks in the Maryland Coastal Plain; and (5) develop science-based tools to facilitate sound management of the ground-water resources in the Maryland Coastal Plain. The assessment, as designed, will be conducted in three phases and if fully implemented, is expected to take 7 to 8 years to complete. Phase I, which was initiated in January 2006, is an effort to assemble all the information and investigation tools needed to do a more comprehensive assessment of the aquifer system. The work will include updating the hydrogeologic framework, developing a Geographic Information System-based aquifer information system, refinement of water-use information, assessment of existing water-quality data, and development of detailed plans for ground-water-flow and management models. Phase II is an intensive study phase during which a regional ground-water-flow model will be developed and calibrated for the entire region of Maryland in the Atlantic Coastal Plain as well as appropriate areas of Delaware and Virginia. The model will be used to simulate flow and water levels in the aquifer system and to study the water budget of the system. The model analysis will be based on published information but will be supplemented with field investigations of recharge and leakage in the aquifer system. Localized and finely discretized ground-water-flow models that are embedded in the regional model will be developed for selected areas of heavy withdrawals. Other modeling studies will be conducted to better understand flow in the unconfined parts of the aquifer system and to support the recharge studies. Phase II will also include selected water-quality studies and a study to determine how hydrologic and water-quality-monitoring networks need to be enhanced to appropriately assess the sustainability of the Coastal Plain aquifer system. Phase III will be largely devoted to the development and application of a ground-water optimization model. This model will be linked to the ground-water-flow model to create a model package that can be used to test different water-management scenarios. The management criteria that will be used to develop these scenarios will be determined in consultation with a variety of state and local stakeholders and policy makers in Phases I and II of the assessment. The development of the aquifer information system is a key component of the assessment. The system will store all relevant aquifer data

  17. Enhancing treatment fidelity in psychotherapy research: novel approach to measure the components of cognitive behavioural therapy for relapse prevention in first-episode psychosis.

    PubMed

    Alvarez-Jimenez, Mario; Wade, Darryl; Cotton, Sue; Gee, Donna; Pearce, Tracey; Crisp, Kingsley; McGorry, Patrick D; Gleeson, John F

    2008-12-01

    Establishing treatment fidelity is one of the most important aspects of psychotherapy research. Treatment fidelity refers to the methodological strategies used to examine and enhance the reliability and validity of psychotherapy. This study sought to develop and evaluate a measure specifically designed to assess fidelity to the different therapeutic components (i.e. therapy phases) of the individual intervention of a psychotherapy clinical trial (the EPISODE II trial). A representative sample of sessions stratified by therapy phase was assessed using a specifically developed fidelity measure (Relapse Prevention Therapy-Fidelity Scale, RPT-FS). Each RPT-FS subscale was designed to include a different component/phase of therapy and its major therapeutic ingredients. The measure was found to be reliable and had good internal consistency. The RPT-FS discriminated, almost perfectly, between therapy phases. The analysis of the therapeutic strategies implemented during the intervention indicated that treatment fidelity was good throughout therapy phases. While therapists primarily engaged in interventions from the appropriate therapeutic phase, flexibility in therapy was evident. This study described the development of a brief, reliable and internally consistent measure to determine both treatment fidelity and the therapy components implemented throughout the intervention. This methodology can be potentially useful to determine those components related to therapeutic change.

  18. Evaluation of sticky traps for adult Aedes mosquitoes in Malaysia: a potential monitoring and surveillance tool for the efficacy of control strategies.

    PubMed

    Roslan, Muhammad Aidil; Ngui, Romano; Vythilingam, Indra; Sulaiman, Wan Yusoff Wan

    2017-12-01

    The present study compared the performance of sticky traps in order to identify the most effective and practical trap for capturing Aedes aegypti and Aedes albopictus mosquitoes. Three phases were conducted in the study, with Phase 1 evaluating the five prototypes (Models A, B, C, D, and E) of sticky trap release-and-recapture using two groups of mosquito release numbers (five and 50) that were released in each replicate. Similarly, Phase 2 compared the performance between Model E and the classical ovitrap that had been modified (sticky ovitrap), using five and 50 mosquito release numbers. Further assessment of both traps was carried out in Phase 3, in which both traps were installed in nine sampling grids. Results from Phase 1 showed that Model E was the trap that recaptured higher numbers of mosquitoes when compared to Models A, B, C, and D. Further assessment between Model E and the modified sticky ovitrap (known as Model F) found that Model F outperformed Model E in both Phases 2 and 3. Thus, Model F was selected as the most effective and practical sticky trap, which could serve as an alternative tool for monitoring and controlling dengue vectors in Malaysia. © 2017 The Society for Vector Ecology.

  19. A simulation study of Large Area Crop Inventory Experiment (LACIE) technology

    NASA Technical Reports Server (NTRS)

    Ziegler, L. (Principal Investigator); Potter, J.

    1979-01-01

    The author has identified the following significant results. The LACIE performance predictor (LPP) was used to replicate LACIE phase 2 for a 15 year period, using accuracy assessment results for phase 2 error components. Results indicated that the (LPP) simulated the LACIE phase 2 procedures reasonably well. For the 15 year simulation, only 7 of the 15 production estimates were within 10 percent of the true production. The simulations indicated that the acreage estimator, based on CAMS phase 2 procedures, has a negative bias. This bias was too large to support the 90/90 criterion with the CV observed and simulated for the phase 2 production estimator. Results of this simulation study validate the theory that the acreage variance estimator in LACIE was conservative.

  20. Assessing the Assessment: Rubrics Training for Pre-Service and New In-Service Teachers

    ERIC Educational Resources Information Center

    Lovorn, Michael G.; Rezaei, Ali Reza

    2011-01-01

    Recent studies report that the use of rubrics may not improve the reliability of assessment if raters are not well trained on how to design and employ them effectively. The intent of this two-phase study was to test if training pre-service and new in-service teachers in the construction, use, and evaluation of rubrics would improve the reliability…

  1. Ecotoxicological assessment of aquatic sediments with Caenorhabditis elegans (Nematoda) -- A method for testing liquid medium and whole-sediment samples

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

    Traunspurger, W.; Haitzer, M.; Hoess, S.

    1997-02-01

    The authors present a method using the free-living nematode Caenorhabditis elegans to assess toxicity in liquid medium and whole-sediment setups. Test duration is 72 h; endpoints are body length, number of eggs inside worms, percentage of gravid worms, and number of offspring per worm. The effect of CdCl{sub 2} on C. elegans in liquid-phase exposures is described as an example. Results from a field study with cadmium polluted sediments from the River Elbe (Germany) suggest that nematodes may be useful organisms in assessing toxicity of sediments in the whole phase.

  2. DEVELOPMENT OF MULTI-PHASE AND MULTI-COMPONENT FLOW MODEL WITH REACTION IN POROUS MEDIA FOR RISK ASSESSMENT ON SOIL CONTAMINATION DUE TO MINERAL OIL

    NASA Astrophysics Data System (ADS)

    Sakamoto, Yasuhide; Nishiwaki, Junko; Hara, Junko; Kawabe, Yoshishige; Sugai, Yuichi; Komai, Takeshi

    In late years, soil contamination due to mineral oil in vacant lots of oil factory and oil field has become obvious. Measure for soil contamina tion and risk assessment are neces sary for sustainable development of industrial activity. Especially, in addition to contaminated sites, various exposure paths for human body such as well water, soil and farm crop are supposed. So it is very important to comprehend the transport phenomena of contaminated material under the environments of soil and ground water. In this study, mineral oil as c ontaminated material consisting of mu lti-component such as aliphatic and aromatic series was modeled. Then numerical mode l for transport phenomena in surface soil and aquifer was constructed. On the basis of modeling for mineral oil, our numerical model consists of three-phase (oil, water and gas) forty three-component. This numerical model becomes base program for risk assessment system on soil contamination due to mineral oil. Using this numerical model, we carried out some numerical simulation for a laboratory-scale experiment on oil-water multi-phase flow. Relative permeability that dominate flow behavior in multi-phase condition was formulated and the validity of the numerical model developed in this study was considered.

  3. Insights into the development of fungal biomarkers for metal ecotoxicity assessment: case of Trametes versicolor exposed to copper.

    PubMed

    Lebrun, Jérémie D; Trinsoutrot-Gattin, Isabelle; Laval, Karine; Mougin, Christian

    2010-04-01

    The relationship between the physiological state of fungi and the response of their functional system to metals is not known, limiting the use of fungal enzymes as tools for assessing metal ecotoxicity in terrestrial ecosystems. The present study attempts to establish how the development phases modulate the secretion of enzymes in the filamentous fungus Trametes versicolor after exposure to Cu. For that purpose, extracellular hydrolases (acid and alkaline phosphatases, aryl-sulfatase, beta-glucosidase, beta-galactosidase, and N-acetyl-beta-glucosaminidase) and oxidoreductases (laccase, manganese and lignin peroxidases) were monitored in liquid cultures for 2 weeks. Copper was added during either the growth or the stationary phases at 20 or 200 ppm. Results of the present study showed that Cu at the highest concentration modifies the secretion of enzymes, regardless of the development phase to which the fungus was exposed. However, the sensitivity of enzyme responses to Cu depended on the phase development and the type of secreted enzyme. In a general way, the production of hydrolases was decreased by Cu, whereas that of oxidoreductases was highly increased. Furthermore, lignin peroxidase was not detected in control cultures and was specifically produced in the presence of Cu. In conclusion, fungal oxidoreductases may be enzymatic biomarkers of copper exposure for ecotoxicity assessment. (c) 2009 SETAC.

  4. Assessing Honor Code Effectiveness: Results of a Multipronged Approach from a Five Year Study

    ERIC Educational Resources Information Center

    Sledge, Sally; Pringle, Pam

    2010-01-01

    This paper describes an ongoing study at a small public university to assess student, faculty and alumni perceptions of academic integrity and business ethics. The phases of the research are detailed for application or replication by other institutions of higher education. The study involves anonymous surveys and academic integrity-based…

  5. Assessing the Selectivity of Extractant Solutions for Recovering Labile Arsenic Associated with Iron (Hydr)oxides and Sulfides in Sediments

    EPA Science Inventory

    Sequential extractions can provide analytical constraints on the identification of mineral phases that control arsenic speciation in sediments. Model solids were used in this study to evaluate different solutions designed to extract arsenic from relatively labile solid phases. ...

  6. Training: An Opportunity for People with Disabilities in School Foodservice Operations

    ERIC Educational Resources Information Center

    Paez, Paola; Arendt, Susan; Strohbehn, Catherine

    2011-01-01

    Purpose/Objectives: This study assessed current training methods and topics used at public school foodservice operations as well as school foodservice representatives' attitudes toward training employees with disabilities. Methods: A mixed method approach of data collection included two phases. Phase I used a more qualitative approach; interviews…

  7. Consumer Fraud: An Empirical Perspective. Summary.

    ERIC Educational Resources Information Center

    Schubert, Jane G.; And Others

    The American Institutes for Research (AIR) and the National Consumer Law Center (NCLC) studied consumer fraud and assessed possible intervention. Phase I produced an AIR description of the nature, scope, and characteristics of consumer fraud and an NCLC compilation of the laws and regulations which control it. In Phase II AIR developed…

  8. Couple Therapy with Veterans: Early Improvements and Predictors of Early Dropout.

    PubMed

    Fischer, Melanie S; Bhatia, Vickie; Baddeley, Jenna L; Al-Jabari, Rawya; Libet, Julian

    2017-07-28

    Family services within Veterans Affairs Medical Centers fulfill an important role in addressing relationship distress among Veterans, which is highly prevalent and comorbid with psychopathology. However, even for evidence-based couple therapies, effectiveness is weaker compared to controlled studies, maybe because many Veteran couples drop out early and do not reach the "active" treatment stage after the 3-4 session assessment. In order to improve outcomes, it is critical to identify couples at high risk for early dropout, and understand whether couples may benefit from the assessment as an intervention. The current study examined (a) demographics, treatment delivery mode, relationship satisfaction, and psychological symptoms as predictors of dropout during and immediately following the assessment phase, and (b) changes in relationship satisfaction during assessment. 174 couples completed questionnaires during routine intake procedures. The main analyses focused on 140 male Veterans and their female civilian partners; 36.43% dropped out during the assessment phase and 24.74% of the remaining couples immediately following the first treatment session. More severe depressive symptoms in non-Veteran partners were associated with dropout during assessment. Relationship satisfaction improved significantly during the assessment phase for couples who did not drop out, with larger gains for non-Veteran partners. No demographics or treatment delivery mode were associated with dropout. Although more research is needed on engaging couples at risk for early dropout and maximizing early benefits, the findings suggest that clinicians should attend to the civilian partner's and Veteran's depressive symptoms at intake and consider the assessment part of active treatment. © 2017 Family Process Institute.

  9. The chronology of third molar eruption in the Croatian population.

    PubMed

    Brkić, Hrvoje; Vodanović, Marin; Dumancić, Jelena; Lovrić, Zeljka; Cuković-Bagić, Ivana; Petrovecki, Mladen

    2011-06-01

    Dental age estimation is common in orthodontics, paedodontics, paleodontology and forensic dentistry. The aim of this study was to assess chronological course of eruptive developmental phases of third molar and to establish parameters for the Croatian population. Sample of this study consisted of 1249 orthopantomograms of 530 (42.4%) male and 719 (57.6%) female subjects, aged 10 to 25 years. Eruptive phases were classified in 4 stages. No significant sex difference was found. Established chronology of the third molar eruption can be used as a standard for the assessment of dental age in clinical and forensic research on samples of Croatian population.

  10. Artificial gravity as a multi-system countermeasure: effects on cognitive function.

    PubMed

    Seaton, Kimberly A; Slack, Kelley J; Sipes, Walter; Bowie, Kendra

    2007-07-01

    The Space Flight Cognitive Assessment Tool for Windows (WinSCAT) is used on the International Space Station to evaluate cognitive functioning after physical insult or trauma. The current study uses WinSCAT to assess cognitive functioning in a space flight analog (bed rest) environment where intermittent artificial gravity (AG) is being tested as a countermeasure. Fifteen male subjects (8 treatment, 7 control), who participated in 21 days of 6 degree head-down tilt bed rest, were assessed during the acclimatization phase, bed rest phase, and recovery phase. Individual differences were found within both the treatment and control groups. The treatment group accounted for more off-nominal WinSCAT scores than the control group. The length of time spent in bed rest was not associated with a change in cognitive function. Individual differences in underlying cognitive ability and motivation level are other possible explanations for the current findings.

  11. Children and Young People-Mental Health Safety Assessment Tool (CYP-MH SAT) study: Protocol for the development and psychometric evaluation of an assessment tool to identify immediate risk of self-harm and suicide in children and young people (10–19 years) in acute paediatric hospital settings

    PubMed Central

    Walker, Gemma M; Carter, Tim; Aubeeluck, Aimee; Witchell, Miranda; Coad, Jane

    2018-01-01

    Introduction Currently, no standardised, evidence-based assessment tool for assessing immediate self-harm and suicide in acute paediatric inpatient settings exists. Aim The aim of this study is to develop and test the psychometric properties of an assessment tool that identifies immediate risk of self-harm and suicide in children and young people (10–19 years) in acute paediatric hospital settings. Methods and analysis Development phase: This phase involved a scoping review of the literature to identify and extract items from previously published suicide and self-harm risk assessment scales. Using a modified electronic Delphi approach, these items will then be rated according to their relevance for assessment of immediate suicide or self-harm risk by expert professionals. Inclusion of items will be determined by 65%–70% consensus between raters. Subsequently, a panel of expert members will convene to determine the face validity, appropriate phrasing, item order and response format for the finalised items. Psychometric testing phase: The finalised items will be tested for validity and reliability through a multicentre, psychometric evaluation. Psychometric testing will be undertaken to determine the following: internal consistency, inter-rater reliability, convergent, divergent validity and concurrent validity. Ethics and dissemination Ethical approval was provided by the National Health Service East Midlands—Derby Research Ethics Committee (17/EM/0347) and full governance clearance received by the Health Research Authority and local participating sites. Findings from this study will be disseminated to professionals and the public via peer-reviewed journal publications, popular social media and conference presentations. PMID:29654046

  12. Tofacitinib, an oral Janus kinase inhibitor, for the treatment of Latin American patients with rheumatoid arthritis: Pooled efficacy and safety analyses of Phase 3 and long-term extension studies.

    PubMed

    Radominski, Sebastião Cezar; Cardiel, Mario Humberto; Citera, Gustavo; Goecke, Annelise; Jaller, Juan Jose; Lomonte, Andrea Barranjard Vannucci; Miranda, Pedro; Velez, Patricia; Xibillé, Daniel; Kwok, Kenneth; Rojo, Ricardo; García, Erika Gabriela

    Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We assessed tofacitinib efficacy and safety in the Latin American (LA) subpopulation of global Phase 3 and long-term extension (LTE) studies. Data from LA patients with RA and inadequate response to disease-modifying antirheumatic drugs (DMARDs) were pooled across five Phase 3 studies. Phase 3 patients received tofacitinib 5 or 10mg twice daily (BID), adalimumab or placebo; patients in the single LTE study received tofacitinib 5 or 10mg BID; treatments were administered alone or with conventional synthetic DMARDs. Efficacy was reported up to 12 months (Phase 3) and 36 months (LTE) by American College of Rheumatology (ACR) 20/50/70 response rates, Disease Activity Score (DAS)28-4(erythrocyte sedimentation rate [ESR]) and Health Assessment Questionnaire-Disability Index (HAQ-DI). Incidence rates (IRs; patients with event/100 patient-years) of adverse events (AEs) of special interest were reported. The Phase 3 studies randomized 496 LA patients; the LTE study enrolled 756 LA patients from Phase 2 and Phase 3. In the Phase 3 studies, patients who received tofacitinib 5 and 10mg BID showed improvements vs placebo at Month 3 in ACR20 (68.9% and 75.7% vs 35.6%), ACR50 (45.8% and 49.7% vs 20.7%) and ACR70 (17.5% and 23.1% vs 6.9%) responses, mean change from baseline in HAQ-DI (-0.6 and -0.8 vs -0.3) and DAS28-4(ESR) score (-2.3 and -2.4 vs -1.4). The improvements were sustained up to Month 36 in the LTE study. In the Phase 3 studies, IRs with tofacitinib 5 and 10mg BID and placebo were 7.99, 6.57 and 9.84, respectively, for SAEs, and 3.87, 5.28 and 3.26 for discontinuation due to AEs. IRs of AEs of special interest in tofacitinib-treated LA patients were similar to the global population. In Phase 3 and LTE studies in LA patients with RA, tofacitinib demonstrated efficacy up to 36 months with a manageable safety profile up to 60 months, consistent with the overall tofacitinib study population. Copyright © 2016 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.

  13. Fatigue and Oxidative Stress in Children Undergoing Leukemia Treatment.

    PubMed

    Rodgers, Cheryl; Sanborn, Chelse; Taylor, Olga; Gundy, Patricia; Pasvogel, Alice; Moore, Ida M Ki; Hockenberry, Marilyn J

    2016-10-01

    Fatigue is a frequent and distressing symptom in children undergoing leukemia treatment; however, little is known about factors influencing this symptom. Antioxidants such as glutathione can decrease symptom severity in adult oncology patients, but no study has evaluated antioxidants' effects on symptoms in pediatric oncology patients. This study describes fatigue patterns and associations of fatigue with antioxidants represented by reduced glutathione (GSH) and the reduced/oxidized glutathione (GSH/GSSG) ratio among children receiving leukemia treatment. A repeated measures design assessed fatigue and antioxidants among 38 children from two large U.S. cancer centers. Fatigue was assessed among school-age children and by parent proxy among young children. Antioxidants (GSH and GSH/GSSG ratio) were assessed from cerebrospinal fluid at four phases during leukemia treatment. Young children had a steady decline of fatigue from the end of induction treatment through the continuation phase of treatment, but no significant changes were noted among the school-age children. Mean antioxidant scores varied slightly over time; however, the GSH/GSSG ratios in these children were significantly lower than the normal ratio. Mean GSH/GSSG ratios significantly correlated to fatigue scores of the school-age children during early phases of treatment. Children with low mean GSH/GSSG ratios demonstrated oxidative stress. The low ratios noted early in therapy were significantly correlated with higher fatigue scores during induction and postinduction treatment phases. This finding suggests that increased oxidative stress during the more intensive phases of therapy may explain the experience of fatigue children report. © The Author(s) 2016.

  14. Cryopyrin-associated periodic syndromes: development of a patient-reported outcomes instrument to assess the pattern and severity of clinical disease activity.

    PubMed

    Hoffman, Hal M; Wolfe, Frederick; Belomestnov, Pavel; Mellis, Scott J

    2008-09-01

    Development of an instrument for characterization of symptom patterns and severity in patients with cryopyrin-associated periodic syndromes (CAPS). Two generations of daily health assessment forms (DHAFs) were evaluated in this study. The first-generation DHAF queried 11 symptoms. Analyses of results obtained with that instrument identified five symptoms included in a revised second-generation DHAF that was tested for internal consistency and test-retest reliability. This DHAF was also assessed during the initial portion of a phase 3 clinical study of CAPS treatment. Forty-eight CAPS patients provided data for the first-generation DHAFs. Five symptoms (rash, fever, joint pain, eye redness/pain, and fatigue) were included in the revised second-generation DHAF. Symptom severity was highly variable during all study phases with as many as 89% of patients reporting at least one symptom flare, and percentages of days with flares reaching 58% during evaluation of the second-generation instrument. Mean composite key symptom scores (KSSs) computed during evaluation of the second-generation DHAF correlated well with Physician's Global Assessment of Disease Activity (r=0.91, p<0.0001) and patient reports of limitations of daily activities (r=0.68, p<0.0001). Test-retest reliability and Cronbach's alpha's were high (0.93 and 0.94, respectively) for the second-generation DHAF. Further evaluation of this DHAF during a baseline period and placebo treatment in a phase 3 clinical study of CAPS patients indicated strong correlations between baseline KSS and Physician's Global Assessment of Disease Activity. Cronbach's alpha's at baseline and test-retest reliability were also high. Potentially important study limitations include small sample size, the lack of a standard tool for CAPS symptom assessment against which to validate the DHAF, and no assessment of the instrument's responsivity to CAPS therapy. The DHAF is a new instrument that may be useful for capturing symptom patterns and severity in CAPS patients and monitoring responses to therapies for these conditions.

  15. Phase II study of docetaxel in combination with epirubicin and protracted venous infusion 5-fluorouracil (ETF) in patients with recurrent or metastatic breast cancer. A Yorkshire breast cancer research group study.

    PubMed

    Humphreys, A C; Dent, J; Rodwell, S; Crawford, S M; Joffe, J K; Bradley, C; Dodwell, D; Perren, T J

    2004-06-01

    This study was originally designed as a phase I/II study, with a dose escalation of docetaxel in combination with epirubicin 50 mg m(-2) and 5-fluorouracil (5-FU) 200 mg m(-2) day(-1). However, as dose escalation was not possible, the study is reported as a phase II study of the combination to assess response and toxicity. A total of 51 patients with locally advanced or metastatic breast cancer were treated on this phase II study, with doses of docetaxel 50 mg m(-2), epirubicin 50 mg m(-2) and infusional 5-FU 200 mg m(-2) day(-1) for 21 days. The main toxicity of this combination was neutropenia with 89% of patients having grade 3 and 4 neutropenia, and 39% of patients experiencing febrile neutropenia. Nonhaematological toxicity was mild. The overall response rate in the assessable patients was 64%, with median progression-free survival of 38 weeks, and median survival of 70 weeks. The ETF regimen was found to be toxic, and it was not possible to escalate the dose of docetaxel above the first dose level. This regimen has therefore not been taken any further, but as a development of this a new study is ongoing, combining 3-weekly epirubicin, weekly docetaxel and capecitabine, days 1-14.

  16. What Works in Oklahoma Schools: A Comprehensive Needs Assessment of Oklahoma Schools. Phase III Action Steps

    ERIC Educational Resources Information Center

    Marzano Research Laboratory, 2011

    2011-01-01

    This document contains the Phase III report from the "What Works in Oklahoma Schools" study. As opposed to describing the findings from the study that was conducted, it provides a tool-kit that can be used by Oklahoma principals and teachers to determine the best courses of action for their schools and classrooms. The tools provided in…

  17. Design of formative assessment model for professional behavior using stages of change theory

    PubMed Central

    Hashemi, Akram; Mirzazadeh, Azim; Shirazi, Mandana; Asghari, Fariba

    2016-01-01

    Background: Professionalism is a core competency of physicians. This study was conducted to design a model for formative assessment of professional commitment in medical students according to stages of change theory. Methods: In this qualitative study, data were collected through literature review & focus group interviews in the Tehran University of Medical Sciences in 2013 and analyzed using content analysis approach. Results: Review of the literature and results of focus group interviews led to design a formative assessment model of professional commitment in three phases, including pre-contemplation, contemplation, and readiness for behavior change that each one has interventional and assessment components. In the second phase of the study, experts’ opinion collected in two main categories: the educational environment (factors related to students, students’ assessment and educational program); and administrative problems (factors related to subcultures, policymakers or managers and budget). Moreover, there was a section of recommendations for each category related to curriculum, professors, students, assessments, making culture, the staff and reinforcing administrative factors. Conclusion: This type of framework analysis made it possible to develop a conceptual model that could be effective on forming the professional commitment and behavioral change in medical students. PMID:28210576

  18. Design of formative assessment model for professional behavior using stages of change theory.

    PubMed

    Hashemi, Akram; Mirzazadeh, Azim; Shirazi, Mandana; Asghari, Fariba

    2016-01-01

    Background: Professionalism is a core competency of physicians. This study was conducted to design a model for formative assessment of professional commitment in medical students according to stages of change theory. Methods: In this qualitative study, data were collected through literature review & focus group interviews in the Tehran University of Medical Sciences in 2013 and analyzed using content analysis approach. Results: Review of the literature and results of focus group interviews led to design a formative assessment model of professional commitment in three phases, including pre-contemplation, contemplation, and readiness for behavior change that each one has interventional and assessment components. In the second phase of the study, experts' opinion collected in two main categories: the educational environment (factors related to students, students' assessment and educational program); and administrative problems (factors related to subcultures, policymakers or managers and budget). Moreover, there was a section of recommendations for each category related to curriculum, professors, students, assessments, making culture, the staff and reinforcing administrative factors. Conclusion: This type of framework analysis made it possible to develop a conceptual model that could be effective on forming the professional commitment and behavioral change in medical students.

  19. An attributional life cycle assessment for an Italian residential multifamily building.

    PubMed

    Vitale, Pierluca; Arena, Umberto

    2017-09-06

    The study describes an attributional life cycle assessment carried out according to the ISO standards and focused on an Italian multifamily residential building. The aim was developing an exhaustive and reliable inventory of high-quality primary data, comparing the environmental impacts along the three stages of the building life cycle. The pre-use phase takes into account the production of all the construction materials, transportation, and on-site assembling. The use phase quantifies the resource consumptions for 50 years of the building utilization and ordinary maintenance. The end-of-life phase includes the building demolition and the management of generated wastes. The results quantify how the design criteria affect the environmental performances of the residential building along its life cycle. The role of the pre-use phase appears remarkable for global warming potential (GWP), due to the huge impacts of steel and concrete production processes. The use phase gives the largest contributions, which reach 77% and 84% of the total, for the categories of global warming and non-renewable energy. The end-of-life phase provides limited avoided impacts. A comparative analysis quantifies the improvements achievable with an alternative type of partitions and external walls. Acronyms: AC: air conditioning; C&DW: construction and demolition waste; CFL: compact fluorescent lamp; DHW: domestic hot water; EC: European Commission; EU: European Union; GDP: gross domestic product; GHG: greenhouse gases; GWP: global warming potential; LCA: life cycle assessment; LCI: life cycle inventory; LCIA: life cycle impact assessment; MFA: material flow analysis; NREP: non-renewable energy potential; RINP: respiratory inorganics potential; WFD: Waste Framework Directive.

  20. A Phase I proof-of-concept and safety trial of sildenafil to treat cerebral vasospasm following subarachnoid hemorrhage.

    PubMed

    Washington, Chad W; Derdeyn, Colin P; Dhar, Rajat; Arias, Eric J; Chicoine, Michael R; Cross, DeWitte T; Dacey, Ralph G; Han, Byung Hee; Moran, Christopher J; Rich, Keith M; Vellimana, Ananth K; Zipfel, Gregory J

    2016-02-01

    Studies show that phosphodiesterase-V (PDE-V) inhibition reduces cerebral vasospasm (CVS) and improves outcomes after experimental subarachnoid hemorrhage (SAH). This study was performed to investigate the safety and effect of sildenafil (an FDA-approved PDE-V inhibitor) on angiographic CVS in SAH patients. A2-phase, prospective, nonrandomized, human trial was implemented. Subarachnoid hemorrhage patients underwent angiography on Day 7 to assess for CVS. Those with CVS were given 10 mg of intravenous sildenafil in the first phase of the study and 30 mg in the second phase. In both, angiography was repeated 30 minutes after infusion. Safety was assessed by monitoring neurological examination findings and vital signs and for the development of adverse reactions. For angiographic assessment, in a blinded fashion, pre- and post-sildenafil images were graded as "improvement" or "no improvement" in CVS. Unblinded measurements were made between pre- and post-sildenafil angiograms. Twelve patients received sildenafil; 5 patients received 10 mg and 7 received 30 mg. There were no adverse reactions. There was no adverse effect on heart rate or intracranial pressure. Sildenafil resulted in a transient decline in mean arterial pressure, an average of 17% with a return to baseline in an average of 18 minutes. Eight patients (67%) were found to have a positive angiographic response to sildenafil, 3 (60%) in the low-dose group and 5 (71%) in the high-dose group. The largest degree of vessel dilation was an average of 0.8 mm (range 0-2.1 mm). This corresponded to an average percentage increase in vessel diameter of 62% (range 0%-200%). The results from this Phase I safety and proof-of-concept trial assessing the use of intravenous sildenafil in patients with CVS show that sildenafil is safe and well tolerated in the setting of SAH. Furthermore, the angiographic data suggest that sildenafil has a positive impact on human CVS.

  1. PubMed Central

    BERRETTINI, S.; ARSLAN, E.; BAGGIANI, A.; BURDO, S.; CASSANDRO, E.; CUDA, D.; FILIPO, R.; GIORGI ROSSI, P.; MANCINI, P.; MARTINI, A.; QUARANTA, A.; QUARANTA, N.; TURCHETTI, G.; FORLI, F.

    2011-01-01

    SUMMARY The aim of Health Technology Assessment (HTA) is to provide decision-makers, distributors and recipients with information on the effectiveness, cost and impact of health technologies. The present study constitutes a subproject within the wider project “Analysis of the impact of professional involvement in evidence generation for the HTA process”, which is part of the strategic programme “Transfer of the results of the research in clinical practice and organisation of healthcare services”, coordinated by Laziosanità – Agency of Public Healthcare of the Lazio Region and AgeNaS (National Agency for Regional Healthcare Services). The objectives of the present subproject (cochlear implants) are as follows: a) to produce a report regarding the health impact of cochlear implants (CI) on their recipients, through a systematic review of literature and extensive selection of relative studies, combining the outcomes with metanalytical techniques. Output: report on the indications of usage in the groups of population for which benefits are controversial; b) to create a registry of patients using cochlear implants. The registry should contain a selection of anagraphic and clinical information relative to patient follow-up in order to assess factors associated with safety and impact on cochlear implant users. This source of information is essential for future observational studies. This was divided into 4 phases: 1st phase: definition of key participants in the assessment process; 2nd phase: definition of methods and timing of “Aims” (definition of the objective); 3rd phase: definition of the methods and times of the “assessment process”, 4th phase: production of the final report. From the analysis of systematic reviews and italian and international guidelines, the Working Group members approved recommendations on the following topics: results after CI in children in relation to age at implantation, bilateral CI in children, CI in deaf children with associated disabilities, CI in adults with advanced age, bilateral CI in adults and CI in adults with pre-lingual deafness. These recommendations have also been evaluated by the Consulting Committee members and approved with minimal suggestions. PMID:22287819

  2. Phase II Clinical Trial of Intraoral Grafting of Human Tissue Engineered Oral Mucosa

    DTIC Science & Technology

    2017-10-01

    experimental arm subject in the small defect study. A protocol amendment in early 2017revised the study inclusionary criteria to include all non ...construed as an official Department of the Army position, policy or decision unless so designated by other documentation. REPORT DOCUMENTATION PAGE...group phase II study to assess the safety and efficacy for use of human EVPOME for soft tissue intraoral grafting procedures compared to the “gold

  3. The influence of listener training on the perceptual assessment of hypernasality.

    PubMed

    Oliveira, Adriana Cristina de Almeida Santos Furlan de; Scarmagnani, Rafaeli Higa; Fukushiro, Ana Paula; Yamashita, Renata Paciello

    2016-04-01

    Introduction A high agreement in the perceptual assessment of hypernasality among different listeners is difficult to achieve. Prior listener training and the standardization of analysis criteria may be effective strategies to decrease the effect of perceptual assessment subjectivity and increase the agreement among listeners. Objective To investigate the influence of prior training on agreement among different listeners in the perceptual assessment of hypernasality. Methods Three experienced speech-language pathologists analyzed 77 audio-recorded speech samples of individuals with repaired cleft palate. During the first phase, the listeners classified hypernasality according to their own criteria, using a 4-point scale. Seventy days later, they were required to complete the training to define the stimuli to be used as anchors for the assessment in the following phase. During the second phase, the listeners analyzed the same samples and rated hypernasality in a 4-point scale, using the anchors defined during training as the criteria. Intra- and interrater agreement in both the phases were calculated by the kappa coefficient. These values were statistically compared using the Z-test. Results The intrarater agreement obtained between the two phases of the study ranged from 0.38 to 0.92, with a statistically significant difference for one of the listeners (p=0.004). The agreement for the hypernasality degree obtained among the three listeners after training (0.54) was significantly higher than that obtained before training (0.37; p=0.044). Conclusion Listener training and the definition of criteria to rate hypernasality lead to the increase of intra- and interrater agreement.

  4. Self-monitoring and psychoeducation in bipolar patients with a smart-phone application (SIMPLe) project: design, development and studies protocols.

    PubMed

    Hidalgo-Mazzei, Diego; Mateu, Ainoa; Reinares, María; Undurraga, Juan; Bonnín, Caterina del Mar; Sánchez-Moreno, José; Vieta, Eduard; Colom, Francesc

    2015-03-20

    New technologies have recently been used for monitoring signs and symptoms of mental health illnesses and particularly have been tested to improve the outcomes in bipolar disorders. Web-based psychoeducational programs for bipolar disorders have also been implemented, yet to our knowledge, none of them have integrated both approaches in one single intervention. The aim of this project is to develop and validate a smartphone application to monitor symptoms and signs and empower the self-management of bipolar disorder, offering customized embedded psychoeducation contents, in order to identify early symptoms and prevent relapses and hospitalizations. The project will be carried out in three complementary phases, which will include a feasibility study (first phase), a qualitative study (second phase) and a randomized controlled trial (third phase) comparing the smartphone application (SIMPLe) on top of treatment as usual with treatment as usual alone. During the first phase, feasibility and satisfaction will be assessed with the application usage log data and with an electronic survey. Focus groups will be conducted and technical improvements will be incorporated at the second phase. Finally, at the third phase, survival analysis with multivariate data analysis will be performed and relationships between socio-demographic, clinical variables and assessments scores with relapses in each group will be explored. This project could result in a highly available, user-friendly and not costly monitoring and psychoeducational intervention that could improve the outcome of people suffering from bipolar disorders in a practical and secure way. Clinical Trials.gov: NCT02258711 (October 2014).

  5. Best Practices for Competency Development and Assessment in Higher Education

    ERIC Educational Resources Information Center

    Redondo Duarte, Sara; Learreta Ramos, Begoña; Ruiz Rosillo, María Auxiliadora; Alperstedt, Cristiane; Hazé, Emmanuël

    2015-01-01

    The main objective of this article is to present the results of a study aimed at determining, classifying and evaluating practices of interest for general competency development and assessment in undergraduate programmes. The study encompassed the following phases: (1) focus group in order to establish a starting point regarding competency…

  6. Human norovirus inactivation in oysters by high hydrostatic pressure processing: A randomized double-blinded study

    USDA-ARS?s Scientific Manuscript database

    This randomized, double-blinded, clinical trial assessed the effect of high hydrostatic pressure processing (HPP) on genogroup I.1 human norovirus (HuNoV) inactivation in virus-seeded oysters when ingested by subjects. The safety and efficacy of HPP treatments were assessed in three study phases wi...

  7. Effects of Inservice Teacher Training on Correct Implementation of Assessment and Instructional Procedures for Teachers of Students with Profound Multiple Disabilities

    ERIC Educational Resources Information Center

    Horrocks, Erin L.; Morgan, Robert L.

    2011-01-01

    A multicomponent training package (live training, video modeling, role playing, and feedback) was used to train teachers to conduct assessment and to instruct students with profound multiple disabilities. Phase 1 of the study involved training seven teachers to conduct assessment in three areas: (a) preference assessment (i.e., identification of…

  8. Development and Validation of a Fatigue Assessment Scale for U.S. Construction Workers

    PubMed Central

    Zhang, Mingzong; Sparer, Emily H.; Murphy, Lauren A.; Dennerlein, Jack T.; Fang, Dongping; Katz, Jeffrey N.; Caban-Martinez, Alberto J.

    2015-01-01

    Objective To develop a fatigue assessment scale and test its reliability and validity for commercial construction workers. Methods Using a two-phased approach, we first identified items for the development of a Fatigue Assessment Scale for Construction Workers (FASCW) through review of existing scales in the scientific literature, key informant interviews (n=11) and focus groups (3 groups with 6 workers each) with construction workers. The second phase included assessment for the reliability, validity and sensitivity of the new scale using a repeated-measures study design with a convenience sample of construction workers (n=144). Results Phase one resulted in a 16-item preliminary scale that after factor analysis yielded a final 10-item scale with two sub-scales (“Lethargy” and “Bodily Ailment”).. During phase two, the FASCW and its subscales demonstrated satisfactory internal consistency (alpha coefficients were FASCW (0.91), Lethargy (0.86) and Bodily Ailment (0.84)) and acceptable test-retest reliability (Pearson Correlations Coefficients: 0.59–0.68; Intraclass Correlation Coefficients: 0.74–0.80). Correlation analysis substantiated concurrent and convergent validity. A discriminant analysis demonstrated that the FASCW differentiated between groups with arthritis status and different work hours. Conclusions The 10-item FASCW with good reliability and validity is an effective tool for assessing the severity of fatigue among construction workers. PMID:25603944

  9. A technology-assisted learning setup as assessment supplement for three persons with a diagnosis of post-coma vegetative state and pervasive motor impairment.

    PubMed

    Lancioni, Giulio E; Singh, Nirbhay N; O'Reilly, Mark F; Sigafoos, Jeff; Buonocunto, Francesca; Sacco, Valentina; Colonna, Fabio; Navarro, Jorge; Lanzilotti, Crocifissa; Bosco, Andrea; Megna, Gianfranco; De Tommaso, Marina

    2009-01-01

    Post-coma persons in an apparent condition of vegetative state and pervasive motor impairment pose serious problems in terms of assessment and intervention options. A technology-based learning assessment procedure might serve for them as a diagnostic supplement with possible implications for rehabilitation intervention. The learning assessment procedure adopted in this study relied on hand-closure and eye-blinking responses and on microswitch technology to detect such responses and to present stimuli. Three participants were involved in the study. The technology consisted of a touch/pressure sensor fixed on the hand or an optic sensor mounted on an eyeglasses' frame, which were combined with a control system linked to stimulus sources. The study adopted an ABABCB sequence, in which A represented baseline periods, B intervention periods with stimuli contingent on the responses, and C a control condition with stimuli presented non-contingently. Data showed that the level of responding during the B phases was significantly higher than the levels observed during the A phases as well as the C phase for two of the three participants (i.e., indicating clear signs of learning by them). Learning might be deemed to represent basic levels of knowledge/consciousness. Thus, detecting signs of learning might help one revise a previous diagnosis of vegetative state with wide implications for rehabilitation perspectives.

  10. ORANGES evaluation phase I risk assessment report : phase I of the US DOT sponsored evaluation of the ORANGES electronic payment system field operational test

    DOT National Transportation Integrated Search

    2004-03-11

    This document is the US DOT evaluation Risk Assessment report for Phase I of the ORANGES field operational test. This document consolidates working papers and incorporates an assessment of issues, risks, mitigation strategies and lessons learned look...

  11. Reproducibility of CT Perfusion Parameters in Liver Tumors and Normal Liver

    PubMed Central

    Ng, Chaan S.; Chandler, Adam G.; Wei, Wei; Herron, Delise H.; Anderson, Ella F.; Kurzrock, Razelle; Charnsangavej, Chusilp

    2011-01-01

    Purpose: To assess the reproducibility of computed tomographic (CT) perfusion measurements in liver tumors and normal liver and effects of motion and data acquisition time on parameters. Materials and Methods: Institutional review board approval and written informed consent were obtained for this prospective study. The study complied with HIPAA regulations. Two CT perfusion scans were obtained 2–7 days apart in seven patients with liver tumors with two scanning phases (phase 1: 30-second breath-hold cine; phase 2: six intermittent free-breathing cines) spanning 135 seconds. Blood flow (BF), blood volume (BV), mean transit time (MTT), and permeability–surface area product (PS) for tumors and normal liver were calculated from phase 1 with and without rigid registration and, for combined phases 1 and 2, with manually and rigid-registered phase 2 images, by using deconvolution modeling. Variability was assessed with within-patient coefficients of variation (CVs) and Bland-Altman analyses. Results: For tumors, BF, BV, MTT, and PS values and reproducibility varied by analytical method, the former by up to 11%, 23%, 21%, and 138%, respectively. Median PS values doubled with the addition of phase 2 data to phase 1 data. The best overall reproducibility was obtained with rigidly registered phase 1 and phase 2 images, with within-patient CVs for BF, BV, MTT, and PS of 11.2%, 14.4%, 5.5% and 12.1%, respectively. Normal liver evaluations were similar, except with marginally lower variability. Conclusion: Absolute values and reproducibility of CT perfusion parameters were markedly influenced by motion and data acquisition time. PS, in particular, probably requires data acquisition beyond a single breath hold, for which motion-correction techniques are likely necessary. © RSNA, 2011 Supplemental material: http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.11110331/-/DC1 PMID:21788525

  12. Development of Autonomous Aerobraking - Phase 2

    NASA Technical Reports Server (NTRS)

    Murri, Daniel G.

    2013-01-01

    Phase 1 of the Development of Autonomous Aerobraking (AA) Assessment investigated the technical capability of transferring the processes of aerobraking maneuver (ABM) decision-making (currently performed on the ground by an extensive workforce and communicated to the spacecraft via the deep space network) to an efficient flight software algorithm onboard the spacecraft. This document describes Phase 2 of this study, which was a 12-month effort to improve and rigorously test the AA Development Software developed in Phase 1. Aerobraking maneuver; Autonomous Aerobraking; Autonomous Aerobraking Development Software; Deep Space Network; NASA Engineering and Safety Center

  13. On entropy change measurements around first order phase transitions in caloric materials.

    PubMed

    Caron, Luana; Ba Doan, Nguyen; Ranno, Laurent

    2017-02-22

    In this work we discuss the measurement protocols for indirect determination of the isothermal entropy change associated with first order phase transitions in caloric materials. The magneto-structural phase transitions giving rise to giant magnetocaloric effects in Cu-doped MnAs and FeRh are used as case studies to exemplify how badly designed protocols may affect isothermal measurements and lead to incorrect entropy change estimations. Isothermal measurement protocols which allow correct assessment of the entropy change around first order phase transitions in both direct and inverse cases are presented.

  14. System technology analysis of aeroassisted orbital transfer vehicles: Moderate lift/drag (0.75-1.5). Volume 2: Supporting research and technology report, phase 1 and 2

    NASA Technical Reports Server (NTRS)

    1985-01-01

    Technology payoffs of representative ground based (Phase 1) and space based (Phase 2) mid lift/drag ratio (L/D) aeroassisted orbit transfer vehicles (AOTV) were assessed and prioritized. The methodology employed to generate technology payoffs, the major payoffs identified, the urgency of the technology effort required, and the technology plans suggested are summarized for both study phases. Technology issues concerning aerodynamics, aerothermodynamics, thermal protection, propulsion, and guidance, navigation and control are addressed.

  15. Wellness-Promoting Practices Through Girl Scouts: A Pragmatic Superiority Randomized Controlled Trial With Additional Dissemination.

    PubMed

    Cull, Brooke J; Dzewaltowski, David A; Guagliano, Justin M; Rosenkranz, Sara K; Knutson, Cassandra K; Rosenkranz, Richard R

    2018-01-01

    To evaluate the effectiveness of in-person versus online Girl Scout leader wellness training for implementation of wellness-promoting practices during troop meetings (phase I) and to assess training adoption and current practices across the council (phase II). Pragmatic superiority trial (phase 1) followed by serial cross-sectional study (phase II). Girl Scout troop meetings in Northeast Kansas. Eighteen troop leaders from 3 counties (phase 1); 113 troop leaders from 7 counties (phase II). Phase I: Troop leaders attended 2 wellness training sessions (first in groups, second individually), wherein leaders set wellness-promoting practice implementation goals, self-monitored progress, and received guidance and resources for implementation. Leaders received the intervention in person or online. Phase I: At baseline and postintervention, leaders completed a wellness-promoting practice implementation questionnaire assessing practices during troop meetings (max score = 11). Phase II: Leaders completed a survey about typical troop practices and interest in further training. Phase I: Generalized linear mixed modeling. Phase I: In-person training increased wellness-promoting practice implementation more than online training (in person = 2.1 ± 1.8; online = 0.2 ± 1.2; P = .022). Phase II: Fifty-six percent of leaders adopted the training. For 8 of 11 wellness categories, greater than 50% of leaders employed wellness-promoting practices. In-person training was superior to online training for improvements in wellness-promoting practices. Wellness training was adopted by the majority of leaders across the council.

  16. In vivo assessment of iron content of the cerebral cortex in healthy aging using 7-Tesla T2*-weighted phase imaging.

    PubMed

    Buijs, Mathijs; Doan, Nhat Trung; van Rooden, Sanneke; Versluis, Maarten J; van Lew, Baldur; Milles, Julien; van der Grond, Jeroen; van Buchem, Mark A

    2017-05-01

    Accumulation of brain iron has been suggested as a biomarker of neurodegeneration. Increased iron has been seen in the cerebral cortex in postmortem studies of neurodegenerative diseases and healthy aging. Until recently, the diminutive thickness of the cortex and its relatively low iron content have hampered in vivo study of cortical iron accumulation. Using phase images of a T2*-weighted sequence at ultrahigh field strength (7 Tesla), we examined the iron content of 22 cortical regions in 70 healthy subjects aged 22-80 years. The cortex was automatically segmented and parcellated, and phase shift was analyzed using an in-house developed method. We found a significant increase in phase shift with age in 20 of 22 cortical regions, concurrent with current understanding of cortical iron accumulation. Our findings suggest that increased cortical iron content can be assessed in healthy aging in vivo. The high spatial resolution and sensitivity to iron of our method make it a potentially useful tool for studying cortical iron accumulation in healthy aging and neurodegenerative diseases. Copyright © 2016 Elsevier Inc. All rights reserved.

  17. Quality of life of pulmonary TB patients after intensive phase treatmentin the health centers of Medan city, Indonesia

    NASA Astrophysics Data System (ADS)

    Wahyuni, A. S.; Soeroso, N.; Harahap, J.; Amelia, R.; Alona, I.

    2018-03-01

    Tuberculosis (TB) is one of the chronic diseases that has become a long major health problem in the world, as well as in Indonesia. TB treatment takes a long time (6-9 months) to cover both intensive and advanced phases. TB patients experience significant disruptions in their social life, exposed to stigma and discrimination. The purpose of this study was to determine the quality of life of TB patients after two months of TB intensive treatment phase. We conducted a quantitative study through cross-sectional design. This research recruited 100 TB patients aged > 18 years old and Category I with AFB(+) result. We involved patients from 7 Health Centers in Medan City. We utilised SF 36 instrument to assess the patients quality of lifein the interview. To analyse the collected data, we performed Independent t-analysis. The result of this study was that the quality of life of TB patients who had undergone initial treatment phase wasina low category with a score of 63.9. The two best-measured aspects of quality of life among the eight dimensions assessed in the instrument were pain and physical function.

  18. LV dyssynchrony as assessed by phase analysis of gated SPECT myocardial perfusion imaging in patients with Wolff-Parkinson-White syndrome.

    PubMed

    Chen, Chun; Li, Dianfu; Miao, Changqing; Feng, Jianlin; Zhou, Yanli; Cao, Kejiang; Lloyd, Michael S; Chen, Ji

    2012-07-01

    The purpose of this study was to evaluate left ventricular (LV) mechanical dyssynchrony in patients with Wolff-Parkinson-White (WPW) syndrome pre- and post-radiofrequency catheter ablation (RFA) using phase analysis of gated single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI). Forty-five WPW patients were enrolled and had gated SPECT MPI pre- and 2-3 days post-RFA. Electrophysiological study (EPS) was used to locate accessory pathways (APs) and categorize the patients according to the AP locations (septal, left and right free wall). Electrocardiography (ECG) was performed pre- and post-RFA to confirm successful elimination of the APs. Phase analysis of gated SPECT MPI was used to assess LV dyssynchrony pre- and post-RFA. Among the 45 patients, 3 had gating errors, and thus 42 had SPECT phase analysis. Twenty-two patients (52.4%) had baseline LV dyssynchrony. Baseline LV dyssynchrony was more prominent in the patients with septal APs than in the patients with left or right APs (p < 0.05). RFA improved LV synchrony in the entire cohort and in the patients with septal APs (p < 0.01). Phase analysis of gated SPECT MPI demonstrated that LV mechanical dyssynchrony can be present in patients with WPW syndrome. Septal APs result in the greatest degree of LV mechanical dyssynchrony and afford the most benefit after RFA. This study supports further investigation in the relationship between electrical and mechanical activation using EPS and phase analysis of gated SPECT MPI.

  19. Water- and air-quality monitoring of the Sweetwater Reservoir Watershed, San Diego County, California - Phase One results, continued, 2001-2003

    USGS Publications Warehouse

    Mendez, Gregory O.; Foreman, William T.; Morita, Andrew; Majewski, Michael S.

    2008-01-01

    In 1998, the U.S. Geological Survey, in cooperation with the Sweetwater Authority, began a study to monitor water, air, and sediment at the Sweetwater and Loveland Reservoirs in San Diego County, California. The study includes regular sampling of water and air at Sweetwater Reservoir for chemical constituents, including volatile organic compounds (VOC), polynuclear aromatic hydrocarbons (PAH), pesticides, and major and trace elements. The purpose of this study is to monitor changes in contaminant composition and concentration during the construction and operation of State Route 125. To accomplish this, the study was divided into two phases. Phase One sampling (water years 1998–2004) determined baseline conditions for the detection frequency and the concentrations of target compounds in air and water. Phase Two sampling (starting water year 2005) continues at selected monitoring sites during and after construction of State Route 125 to assess the chemical impact this roadway alignment may have on water quality in the reservoir. Water samples were collected for VOCs and pesticides at Loveland Reservoir during Phase One and will be collected during Phase Two for comparison purposes. Air samples collected to monitor changes in VOCs, PAHs, and pesticides were analyzed by adapting methods used to analyze water samples. Bed-sediment samples have been and will be collected three times during the study; at the beginning of Phase One, at the start of Phase Two, and near the end of the study. In addition to the ongoing data collection, several special studies were initiated to assess the occurrence of specific chemicals of concern, such as trace metals, anthropogenic indicator compounds, and pharmaceuticals. This report describes the study design, and the sampling and analytical methods, and presents data from water and air samples collected during the fourth and fifth years of Phase One of the study (October 2001 to September 2003). Data collected during the first three years has been previously published. Three types of quality-control samples were used in this study: blanks, spikes, and replicates. Blanks and spikes are used to estimate result bias, and replicates are used to estimate result variability. Additionally, surrogate compounds were added at the laboratory to samples of VOCs, PAHs, pesticides, anthropogenic indicator compounds, and pharmaceuticals to monitor sample-specific performance of the analytical method.

  20. Development of Environmental Load Estimation Model for Road Drainage Systems in the Early Design Phase

    NASA Astrophysics Data System (ADS)

    Park, Jin-Young; Lee, Dong-Eun; Kim, Byung-Soo

    2017-10-01

    Due to the increasing concern about climate change, efforts to reduce environmental load are continuously being made in construction industry, and LCA (life cycle assessment) is being presented as an effective method to assess environmental load. Since LCA requires information on construction quantity used for environmental load estimation, however, it is not being utilized in the environmental review in the early design phase where it is difficult to obtain such information. In this study, computation system for construction quantity based on standard cross section of road drainage facilities was developed to compute construction quantity required for LCA using only information available in the early design phase to develop and verify the effectiveness of a model that can perform environmental load estimation. The result showed that it is an effective model that can be used in the early design phase as it revealed a 13.39% mean absolute error rate.

  1. Cystone® for 1 year did not change urine chemistry or decrease stone burden in cystine stone formers.

    PubMed

    Erickson, Stephen B; Vrtiska, Terri J; Canzanello, Vincent J; Lieske, John C

    2011-06-01

    Cystine kidney stones frequently recur because inadequate prevention exists. We recruited documented recurrent cystine kidney stone formers (6 men, 4 women, 44 ± 17 years) into a 2-phased study to assess safety and effectiveness of Cystone®, a herbal treatment used to prevent and facilitate passage of cystine kidney stones. The first phase was a randomized double-blinded 12 weeks crossover study assessing the effect of Cystone® versus placebo (2 tablets BID) on urinary chemistries. The second phase was an open label 1 year study of Cystone® to determine if renal stone burden decreased, as assessed by quantitative and subjective assessment of CT. There was no statistically significant change of urinary composition from baseline short (6 weeks) or long (52 weeks) term on Cystone®, including volume (2525, 2611, 2730 ml), pH (6.7, 6.7, 7.05), and cystine excretion (2770, 2889, 4025 μmol). Pre and post-CT was available in nine patients. Although seven kidneys lost stones spontaneously or surgically, overall stone burden increased in seven kidneys, was unchanged in nine, and fell in only two. Quantitative scoring increased in both the left and right kidneys (1602-1667 and 301-2064 volumetric units, respectively). Therefore, this study does not suggest that Cystone® has a favorable effect on urinary chemistries that could decrease cystine stone formation, nor does it appear to prevent stone growth or promote stone passage over a 1-year period.

  2. Assessment of a training programme for the prevention of ventilator-associated pneumonia.

    PubMed

    Jam Gatell, M Rosa; Santé Roig, Montserrat; Hernández Vian, Óscar; Carrillo Santín, Esther; Turégano Duaso, Concepción; Fernández Moreno, Inmaculada; Vallés Daunis, Jordi

    2012-01-01

    Ventilator-associated pneumonia (VAP) is the most frequent nosocomial infection in intensive care units (ICUs). Most published studies have analysed nurses' theoretical knowledge about a specific procedure; however, the transfer of this knowledge to the practice has received little attention. To assess the impact of training session on nurses' knowledge regarding VAP, compliance with VAP preventive measures, VAP incidence and determining whether nursing workload affects compliance. A prospective, quasiexperimental, pre- and post-study of the nursing team in a 16-bed medical/surgical ICU. Pre-intervention phase: a questionnaire to assess nurses' knowledge of VAP prevention measures, direct observation and review of clinical records to assess compliance. Intervention phase: eight training sessions for nurses. The post-intervention phase mirrored the pre-intervention phase. Nurses answered more questions correctly on the post-intervention questionnaire than on the pre-intervention (17·87 ± 2·69 versus 15·91 ± 2·68, p = 0·002). Compliance with the following measures was better during the post-intervention period (p = 0·001): use of the smallest possible nasogastric tube, controlled aspiration of subglottic secretions and endotracheal tube cuff pressure, use of oral chlorhexidine and recording the endotracheal tube fixation number. VAP incidence remained unchanged throughout the study. However, a trend towards lower incidence of late (>4 days after intubation) VAP was observed (4·6 versus 3·1 episodes/1000 ventilation days, p = 0·37). The programme improved both knowledge of and compliance with VAP preventive measures, although improved knowledge did not always result in improved compliance. © 2012 The Authors. Nursing in Critical Care © 2012 British Association of Critical Care Nurses.

  3. The Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE): method and design considerations.

    PubMed

    Boudreaux, Edwin D; Miller, Ivan; Goldstein, Amy B; Sullivan, Ashley F; Allen, Michael H; Manton, Anne P; Arias, Sarah A; Camargo, Carlos A

    2013-09-01

    Due to the concentration of individuals at-risk for suicide, an emergency department visit represents an opportune time for suicide risk screening and intervention. The Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE) uses a quasi-experimental, interrupted time series design to evaluate whether (1) a practical approach to universally screening ED patients for suicide risk leads to improved detection of suicide risk and (2) a multi-component intervention delivered during and after the ED visit improves suicide-related outcomes. This paper summarizes the ED-SAFE's study design and methods within the context of considerations relevant to effectiveness research in suicide prevention and pertinent human participants concerns. 1440 suicidal individuals, from 8 general ED's nationally will be enrolled during three sequential phases of data collection (480 individuals/phase): (1) Treatment as Usual; (2) Universal Screening; and (3) Intervention. Data from the three phases will inform two separate evaluations: Screening Outcome (Phases 1 and 2) and Intervention (Phases 2 and 3). Individuals will be followed for 12 months. The primary study outcome is a composite reflecting completed suicide, attempted suicide, aborted or interrupted attempts, and implementation of rescue procedures during an outcome assessment. While 'classic' randomized control trials (RCT) are typically selected over quasi-experimental designs, ethical and methodological issues may make an RCT a poor fit for complex interventions in an applied setting, such as the ED. ED-SAFE represents an innovative approach to examining the complex public health issue of suicide prevention through a multi-phase, quasi-experimental design embedded in 'real world' clinical settings. Copyright © 2013 Elsevier Inc. All rights reserved.

  4. Organizational member involvement in physical activity coalitions across the United States: development and testing of a novel survey instrument for assessing coalition functioning.

    PubMed

    Bornstein, Daniel B; Pate, Russell R; Beets, Michael W; Saunders, Ruth P; Blair, Steven N

    2015-06-01

    Coalitions are often composed of member organizations. Member involvement is thought to be associated with coalition success. No instrument currently exists for evaluating organizational member involvement in physical activity coalitions. This study aimed to develop a survey instrument for evaluating organizational member involvement in physical activity coalitions. The study was carried out in three phases: (a) developing a draft survey, (b) assessing the content validity of the draft survey, and (c) assessing the underlying factor structure, reliability, and validity of the survey. A cross-sectional design was employed. In Phase 1, a team of experts in survey development produced a draft survey. In Phase 2, the content validity of the draft survey was evaluated by a panel of individuals with expertise in physical activity coalitions. In Phase 3, the survey was administered to 120 individuals on local-, state-, and national-level physical activity coalitions. Responses were subjected to an exploratory factor analysis in order to determine the survey's underlying factor structure, reliability, and validity. Phases 1 and 2yielded a survey instrument with demonstrated content validity. Phase 3 yielded a three-factor model with three subscales: Strategic Alignment, Organizational Alignment, and Providing Input. Each subscale demonstrated high internal consistency reliability and construct validity. The survey instrument developed here demonstrated sound psychometric properties and provides new insight into organizational member involvement in physical activity coalitions. This instrument may be an important tool in developing a more complete picture of coalition functioning in physical activity coalitions specifically and health-based coalitions overall. © 2014 Society for Public Health Education.

  5. Adherence to, and outcomes of, a galactomannan screening protocol in high-risk hematology patients.

    PubMed

    Harricharan, S; Biederman, K; Bombassaro, A M; Lazo-Langner, A; Elsayed, S; Fulford, A; Delport, J A; Xenocostas, A

    2018-04-01

    A twice-weekly galactomannan (gm) screening protocol was implemented in high-risk hematology inpatients. Study objectives were to determine adherence to the protocol, use of selected resources, and patient outcomes. This retrospective cohort study compared outcomes of interest before and after implementation of gm screening. Adults undergoing matched related allogeneic hematopoietic stem-cell transplantation or induction chemotherapy for acute leukemia were eligible. Patients could be enrolled more than once and were evaluated as episodes. Adherence to the gm protocol was assessed in post-implementation episodes. Use of broad-spectrum antifungals (bsafs), consultations (infectious diseases, respirology), and diagnostic procedures (computed tomography imaging, bronchoalveolar lavage) were compared between phases, as were the patient outcomes of all-cause mortality and clinical success (alive and not taking a bsaf). Of 182 episodes consecutively screened, 70 per phase were enrolled. Clinical characteristics and duration of assessment were similar for the phases. Full or partial adherence to the protocol was observed in 61 post-implementation episodes (87%), with full adherence in 40 episodes (57%). More episodes in the pre-implementation phase than in the post-implementation phase involved receipt of bsafs, consultations, and diagnostics (27% vs. 7%, p = 0.02; 46% vs. 26%, p = 0.014; and 46% vs. 31%, p = 0.083 respectively). Although mortality was similar in the two phases, clinical success at the final assessment was observed in fewer pre-implementation than post-implementation episodes (79% vs. 98%, p < 0.001). Implementation of a gm screening protocol was feasible and associated with significantly fewer episodes involving receipt of bsafs and consultations, and with significantly more episodes showing clinical success.

  6. 1976 Pennsylvania Public Television Network Audience Research Project: Phase 1. Audience Definition and Estimation.

    ERIC Educational Resources Information Center

    Lindsay, Carl A.; Southworth, Harrison T.

    The first of three phases to provide the Pennsylvania Public Television Network (PPTN) and its seven component stations with information and procedures for defining, estimating and characterizing audiences, as well as developing programs and assessing reactions to them, this study concentrated on establishing audience definitions. The basic…

  7. The Path to Graduation: A Model Interactive Web Site Design Supporting Doctoral Students

    ERIC Educational Resources Information Center

    Simmons-Johnson, Nicole

    2012-01-01

    Objective. This 2-phase mixed method study assessed 2nd-year doctoral students' and dissertation students' perceptions of the current Graduate School of Education dissertation support Web site, with implications for designing a model dissertation support Web site. Methods. Phase 1 collected quantitative and qualitative data through an…

  8. The Emotional Impact of Forced Migration on Iranian-Americans

    ERIC Educational Resources Information Center

    Golestaneh, Hamideh

    2015-01-01

    In this phenomenological study, thematic analysis was used to gain a better understanding of the lived experience of six Iranian-Americans who migrate Iran for safety and a better life. The researcher assessed the participants' journey phase by phase, to get a deeper understanding of the phenomenon. Overall, emigrating from Iran had both negative…

  9. Safety and hemostatic efficacy of fibrin pad in partial nephrectomy: Results of an open-label Phase I and a randomized, standard-of-care-controlled Phase I/II study

    PubMed Central

    2012-01-01

    Background Bleeding severity, anatomic location, tissue characteristics, and visibility are common challenges encountered while managing intraoperative bleeding, and conventional hemostatic measures (suture, ligature, and cautery) may sometimes be ineffective or impractical. While topical absorbable hemostats (TAH) are useful hemostatic adjuvants, each TAH has associated disadvantages. Methods We evaluated the safety and hemostatic efficacy of a new advanced biologic combination product―fibrin pad―to potentially address some gaps associated with TAHs. Fibrin pad was assessed as adjunctive hemostat in open partial nephrectomy in single-center, open-label, Phase I study (N = 10), and as primary hemostat in multicenter, single-blind, randomized, standard-of-care (SOC)-controlled Phase I/II study (N = 7) in Israel. It was used to control mild-to-moderate bleeding in Phase I and also spurting arterial bleeding in Phase I/II study. Phase I study assessed safety and Phase I/II study, proportion of successes at 10 min following randomization, analyzed by Fisher exact tests at 5% significance level. Results Phase I (N = 10): All patients completed the study. Hemostasis was achieved within 3–4 min (average = 3.1 min) of a single application in all patients. Fibrin pad was found to be safe for human use, with no product-related adverse events reported. Phase I/II (N = 7): Hemostatic success at 10 min (primary endpoint) was achieved in 3/4 patients treated with fibrin pad versus 0/3 patients treated with SOC. No clinically significant change in laboratory or coagulation parameters was recorded, except a case of post-procedural hemorrhage with fibrin pad, which was considered serious and related to the fibrin pad treatment, and required re-operation. Although Data Safety Monitoring Board authorized trial continuation, the sponsor decided against proceeding toward an indication for primary treatment of severe arterial hemorrhage as a replacement for sutures. The study was suspended after 7/30 planned subjects were enrolled. Conclusions The first-in-man trial of fibrin pad demonstrated its safety and efficacy as an adjunctive hemostatic technique for mild-to-moderate bleeding in partial nephrectomy. The study also suggested that the product should not replace sutures or meticulous surgical techniques for the treatment of severe arterial hemorrhage. Trial registration Phase I/II trial, NCT00598130 PMID:23137020

  10. Collaboration and research as key elements for strengthening blood donation in developing nations: the case of Grenada, West Indies.

    PubMed

    Gomez, A; Messam, L L McV; Toner, L

    2013-01-01

    The purpose of the study was to identify ways to strengthen the collaboration between the Grenadian Blood Bank, the St George's University (SGU) chapter of the American Medical Students Association, and St George's University Health Clinic in order to improve the promotion of blood drives and increase the number of volunteer donors. The study had two phases. Phase 1: an assessment of the strengths and needs of the collaborators and of the blood drives. Phase 2 consisted of three student assessments: a cross-sectional survey of second year medical students, a cross-sectional survey of students in the School of Arts and Sciences and a case-control study of factors affecting student donation on the day of blood drives. Embedded within both phases were service-learning opportunities for students. Both phases received approval from SGU's Institutional Review Board. Preliminary achievements included a transient increase in blood donation of twenty per cent during five months though advertising of blood drives remains inadequate. Assessments reveal that most students lack knowledge about the drives, and time (medical students) and fear of needles and infection (Arts and Science students) are potential hindrances to blood donation. The Blood Bank needs to increase its profile on the university campus and develop a more effective promotion of the blood drives addressing the concerns of students. St George's University needs to continue supporting student involvement in health promotion activities and identify ways to ensure the sustainability and continuity of these activities. Collaboration and research are useful and effective means to promote blood donation. College students are potentially an excellent source of collaborators and donors if provided with the promotion skills and participation is made convenient.

  11. Assessing Rates and Predictors of Tachyphylaxis During the Prevention of Recurrent Episodes of Depression With Venlafaxine ER for Two Years (PREVENT) Study

    PubMed Central

    Rothschild, Anthony J.; Dunlop, Boadie W.; Dunner, David L.; Friedman, Edward S.; Gelenberg, Alan; Holland, Peter; Kocsis, James H.; Kornstein, Susan G.; Shelton, Richard; Trivedi, Madhukar H.; Zajecka, John M.; Goldstein, Corey; Thase, Michael E.; Pedersen, Ron; Keller, Martin B.

    2013-01-01

    Background Antidepressant tachyphylaxis describes the return of apathetic depressive symptoms, such as fatigue and decreased motivation, despite continued use of a previously effective treatment. Methods Data were collected from a multiphase, double-blind, placebo-controlled study that assessed the efficacy of venlafaxine extended release (ER) during 2 sequential 1-year maintenance phases (A and B) in patients with recurrent major depressive disorder (MDD). The primary outcome was the cumulative probability of tachyphylaxis in patients receiving venlafaxine ER, fluoxetine, or placebo. Tachyphylaxis was defined as Rothschild Scale for Antidepressant Tachyphylaxis (RSAT) scored ≥ 7 in patients with prior satisfactory therapeutic response. A Kaplan-Meier estimate of the cumulative probability of not experiencing tachyphylaxis, and a 2-sided Fisher exact test was used to assess the relationship between tachyphylaxis and recurrence. Results The maintenance phase A population was comprised of 337 patients (venlafaxine ER [n = 129], fluoxetine [n = 79], placebo [n = 129]), whereas 128 patients (venlafaxine ER [n = 43], fluoxetine [n = 45], placebo [n = 40]) were treated during maintenance phase B. No difference in the probability of experiencing tachyphylaxis were observed between the active treatment groups during either maintenance phase; however, a significant difference between venlafaxine ER and placebo was observed at the completion of maintenance phase A. A significant relationship between tachyphylaxis and recurrence was observed. Limitations Despite demonstrating psychometric validity and reliability, the current definition of tachyphylaxis has not been widely studied Conclusions Although no significant differences were observed in the probability of tachyphylaxis among patients receiving active treatment, the relationship between tachyphylaxis and recurrence suggests that tachyphylaxis may be a predrome of recurrence. PMID:19752838

  12. Diagnostic and therapeutic yield of a patient-controlled portable EEG device with dry electrodes for home-monitoring neurological outpatients-rationale and protocol of the HOMEONE pilot study.

    PubMed

    Neumann, Thomas; Baum, Anne Katrin; Baum, Ulrike; Deike, Renate; Feistner, Helmut; Hinrichs, Hermann; Stokes, Joseph; Robra, Bernt-Peter

    2018-01-01

    The HOME ONE study is part of the larger HOME project, which aims to provide evidence of diagnostic and therapeutic yield ("change of management") of a patient-controlled portable EEG device with dry electrodes for the purposes of EEG home-monitoring neurological outpatients. The HOME ONE study is the first step in the process of investigating whether outpatient EEG home-monitoring changes the diagnosis and treatment of patients in comparison to conventional EEG ("change of management"). Both EEG devices (conventional and portable) will be systematically compared via a two-phase intra-individual assessment.In the first phase (pilot study phase), both EEG devices will be used within neurologist practices (all other things being equal). This pilot study (involving 130 patients) will evaluate the technical usability and efficacy of the new portable dry electrode EEG recorder in comparison to conventional EEG devices. Judgements will be based on technical assessments and EEG record examinations of private practitioners and two experienced neurologists (percent of concordant readings and kappa values).The second phase (feasibility study phase) aims to assess patients' acceptability and feasibility of the EEG home-monitoring and will provide insights into the extent diagnostic and therapeutic yields can be expected.For this purpose, a conventional EEG will be recorded in neurologist practices. Thereafter, the practice staff will instruct the patients on how the portable EEG device functions. The patients will subsequently use the devices in their home environment.The evaluation will compare the before and after documented diagnostic findings and the therapeutic consequences of the private practitioners with those of two experienced neurologists. To the best of our knowledge, this will be the first study of its kind to examine new approaches to diagnosing unclear consciousness disorders or other disorders of the CNS or the cardiovascular system through the use of a patient-controlled portable EEG device with dry electrodes for the purpose of home-monitoring neurological outpatients. If the two phases of the HOME ONE study provide sufficient evidence of diagnostic and therapeutic yields, this would justify (indication-specific) full-scale randomized controlled trials or observational studies. DRKS DRKS00012685. Registered 9 August 2017, retrospectively registered.

  13. Do the peak and mean force methods of assessing vertical jump force asymmetry agree?

    PubMed

    Lake, Jason P; Mundy, Peter D; Comfort, Paul; Suchomel, Timothy J

    2018-05-21

    The aim of this study was to assess agreement between peak and mean force methods of quantifying force asymmetry during the countermovement jump (CMJ). Forty-five men performed four CMJ with each foot on one of two force plates recording at 1,000 Hz. Peak and mean were obtained from both sides during the braking and propulsion phases. The dominant side was obtained for the braking and propulsion phase as the side with the largest peak or mean force and agreement was assessed using percentage agreement and the kappa coefficient. Braking phase peak and mean force methods demonstrated a percentage agreement of 84% and a kappa value of 0.67 (95% confidence limits: 0.45-0.90), indicating substantial agreement. Propulsion phase peak and mean force methods demonstrated a percentage agreement of 87% and a kappa value of 0.72 (95% confidence limits: 0.51-0.93), indicating substantial agreement. While agreement was substantial, side-to-side differences were not reflected equally when peak and mean force methods of assessing CMJ asymmetry were used. These methods should not be used interchangeably, but rather a combined approach should be used where practitioners consider both peak and mean force to obtain the fullest picture of athlete asymmetry.

  14. A learning assessment procedure to re-evaluate three persons with a diagnosis of post-coma vegetative state and pervasive motor impairment.

    PubMed

    Lancioni, Giulio E; Singh, Nirbhay N; O'Reilly, Mark F; Sigafoos, Jeff; de Tommaso, Marina; Megna, Gianfranco; Bosco, Andrea; Buonocunto, Francesca; Sacco, Valentina; Chiapparino, Claudia

    2009-02-01

    Detecting signs of learning in persons with a diagnosis of post-coma vegetative state and profound motor disabilities could modify their diagnostic label and provide new hopes. In this study, three adults with such a diagnosis were exposed to learning assessment to search for those signs. PROCEDURE AND DESIGN: The assessment procedure relied on participants' eye-blinking responses and microswitch-based technology. The technology consisted of an electronically regulated optic microswitch mounted on an eyeglasses' frame that the participants wore during the study and an electronic control system connected to stimulus sources. Each participant followed an ABABCB design, in which A represented baseline periods, B intervention periods with stimuli contingent on the responses and C a control condition with stimuli presented non-contingently. The level of responding during the B phases was significantly higher than the levels observed during the A phases as well as the C phase for all participants (i.e. indicating clear signs of learning by them). These findings may have important implications for (a) changing the participants' diagnostic label and offering them new programme opportunities and (b) including learning assessment within the evaluation package used for persons with post-coma profound multiple disabilities.

  15. A mixed methods study to develop and pilot a competency assessment tool to support midwifery care of women with intellectual disabilities.

    PubMed

    Beake, Sarah; Clark, Louise L; Turner, Toni; Bick, Debra

    2013-08-01

    Recent reports have highlighted the poor quality of health care received by people with intellectual disabilities (otherwise known as 'learning disabilities') in the United Kingdom (UK). UK Confidential Enquiries into maternal deaths have highlighted adverse pregnancy outcomes for women with intellectual disabilities and need for timely and appropriate clinical care. To develop and test a competency assessment tool to support midwifery care of women with intellectual disabilities. A mixed methods study. Large inner city maternity unit. Midwives and key experts in intellectual disabilities, maternity policy and midwifery education. Phase one comprised a systematic narrative review of the literature. Evidence identified informed phase two which included focus groups and interviews. Emergent themes informed the development of a competency assessment tool which was piloted in phase three. Phase one: Four primary research papers and two systematic reviews met the review inclusion criteria. Support to develop parenting skills of women with intellectual disabilities was highlighted as was the need to optimise organisation of maternity services. No studies specifically considered midwifery competencies to support women with intellectual disabilities. Phase two: 23 midwives attended three focus groups and individual interviews were conducted with national leaders in intellectual disability (n=6) and midwifery policy and education (n=7). Themes identified included need for individualised care provided by a known midwife, the importance of effective communication skills and need for clear knowledge and understanding of the legislative framework relevant to intellectual disability. Phase three: A convenience sample of 60 midwives was asked to participate in a pilot study to test the tool, 46 (77%) of whom responded. Thirty midwives (65%) felt competent in their ability to recognise intellectual disability and 37 (80%) competent or expert in understanding women have the right to be offered choice and make informed decisions. A high proportion (n=40, 87%) reported little or no knowledge regarding consent issues. Work to inform timely and appropriate care of women with intellectual disability has been neglected in the UK maternity services. Use of a tool could aid assessment of midwifery competencies to support women with intellectual disability and highlight where further midwifery education and development are needed. Evidence of optimal care for women with intellectual disabilities and their families across the continuum of pregnancy and birth is required. Copyright © 2012 Elsevier Ltd. All rights reserved.

  16. Fluoride Varnish Effect on Preventing Dental Caries in a Sample of 3-6 Years Old Children

    PubMed Central

    Mohammadi, Tayebeh Malek; Hajizamani, Abolghasem; Hajizamani, Hamid Reza; Abolghasemi, Batol

    2015-01-01

    Background: Early childhood caries is one of the most prevalent chronic diseases of children that affect their life and their family in different aspects. Using different types of fluoride is one of the most effective ways for preventing the disease. Fluoride varnish is a topical fluoride product which could use in the community even by non-professional. This study aimed to assess the effect of fluoride varnish on dental caries in a group of children aged 3-6 years old in Kerman kindergarten during 6 month’s period. Materials and Methods: This community interventional study recruited a sample of volunteer children from 12 kindergartens through a cluster sampling. Kindergarten randomly allocated to test and control group after matching. Dental examination was performed in three phases of the study by a trained dentist using criteria of Intentional Caries Detection and Assessment System. Fluoride varnish was applied for test group in the first phase after dental examination and also 3 and 6 months after this phase. Control group has received varnish product just after 3 and 6 months after the first dental exam. Mean decayed, missed and filled teeth (dmft) were compared between and within groups using T-test. Results: From 476 children who participated in the study 55% were boys and the 6 years group was the most frequent group with 35% (166). Mean dmft difference was significant between Phase 1 and 2 (P = 0.05) in the test group but there was no significant difference between Phase 2 and 3 (P = 0.07). The difference was not significant between Phase 1 and 2 (P = 0.09) but it was significant between Phase 1 and 3 (P = 0.03) in the control group. Conclusion: The study results showed a decrease in mean dmft after applying the fluoride varnish which confirms previous studies. PMID:25709364

  17. A comparative assessment of cigarette smoke aerosols using an in vitro air–liquid interface cytotoxicity test

    PubMed Central

    Thorne, David; Dalrymple, Annette; Dillon, Deborah; Duke, Martin; Meredith, Clive

    2015-01-01

    Abstract This study describes the evaluation of a modified air-liquid interface BALB/c 3T3 cytotoxicity method for the assessment of smoke aerosols in vitro. The functionality and applicability of this modified protocol was assessed by comparing the cytotoxicity profiles from eight different cigarettes. Three reference cigarettes, 1R5F, 3R4F and CORESTA Monitor 7 were used to put the data into perspective and five bespoke experimental products were manufactured, ensuring a balanced and controlled study. Manufactured cigarettes were matched for key variables such as nicotine delivery, puff number, pressure drop, ventilation, carbon monoxide, nicotine free dry particulate matter and blend, but significantly modified for vapor phase delivery, via the addition of two different types and quantities of adsorptive carbon. Specifically manufacturing products ensures comparisons can be made in a consistent manner and allows the research to ask targeted questions, without confounding product variables. The results demonstrate vapor-phase associated cytotoxic effects and clear differences between the products tested and their cytotoxic profiles. This study has further characterized the in vitro vapor phase biological response relationship and confirmed that the biological response is directly proportional to the amount of available vapor phase toxicants in cigarette smoke, when using a Vitrocell® VC 10 exposure system. This study further supports and strengthens the use of aerosol based exposure options for the appropriate analysis of cigarette smoke induced responses in vitro and may be especially beneficial when comparing aerosols generated from alternative tobacco aerosol products. PMID:26339773

  18. Analysis of Mission Effectiveness: Modern System Architecture Tools for Project Developers

    DTIC Science & Technology

    2017-12-01

    operator input and scripted instructions to describe low-level flow. Note that the case study in Chapter IV describes one pass through evaluation...capability of the sensors. A constraint on the case study is that each sensor type must cover the entire operations area. Cost is a function of 53...completed. 5. Assessment This case study focuses on the first recursive refinement phase completed in a multi-phase effort to demonstrate the effects

  19. Toward an Operational Definition of Workload: A Workload Assessment of Aviation Maneuvers

    DTIC Science & Technology

    2010-08-01

    and evaluated by the learner . With practice, the learner moves into the second phase, where optimal strategies are strengthened. The final stage of...The first phase demands a great amount of resources as performance is slow and prone to errors. During this phase, strategies are being formulated...asked to assess mental, physical, visual, aural , and verbal demands of each task. The new assessment is a cost effective method of assessing workload

  20. EVALUATING THE GREENNESS OF IONIC LIQUIDS VIA LIFE CYCLE ASSESSMENT

    EPA Science Inventory

    Ionic Liquids have been suggested as "greener" replacements to traditional solvents. However, the environmental impacts of the life cycle phases have not been studied. Such a "cradle to gate" Life Cycle Assessment (LCA) for comparing the environmental impact of various solvents...

  1. Developing an instrument to assess the endoscopic severity of ulcerative colitis: the Ulcerative Colitis Endoscopic Index of Severity (UCEIS).

    PubMed

    Travis, Simon P L; Schnell, Dan; Krzeski, Piotr; Abreu, Maria T; Altman, Douglas G; Colombel, Jean-Frédéric; Feagan, Brian G; Hanauer, Stephen B; Lémann, Marc; Lichtenstein, Gary R; Marteau, Phillippe R; Reinisch, Walter; Sands, Bruce E; Yacyshyn, Bruce R; Bernhardt, Christian A; Mary, Jean-Yves; Sandborn, William J

    2012-04-01

    Variability in endoscopic assessment necessitates rigorous investigation of descriptors for scoring severity of ulcerative colitis (UC). To evaluate variation in the overall endoscopic assessment of severity, the intra- and interindividual variation of descriptive terms and to create an Ulcerative Colitis Endoscopic Index of Severity which could be validated. A two-phase study used a library of 670 video sigmoidoscopies from patients with Mayo Clinic scores 0-11, supplemented by 10 videos from five people without UC and five hospitalised patients with acute severe UC. In phase 1, each of 10 investigators viewed 16/24 videos to assess agreement on the Baron score with a central reader and agreed definitions of 10 endoscopic descriptors. In phase 2, each of 30 different investigators rated 25/60 different videos for the descriptors and assessed overall severity on a 0-100 visual analogue scale. κ Statistics tested inter- and intraobserver variability for each descriptor. A general linear mixed regression model based on logit link and β distribution of variance was used to predict overall endoscopic severity from descriptors. There was 76% agreement for 'severe', but 27% agreement for 'normal' appearances between phase I investigators and the central reader. In phase 2, weighted κ values ranged from 0.34 to 0.65 and 0.30 to 0.45 within and between observers for the 10 descriptors. The final model incorporated vascular pattern, (normal/patchy/complete obliteration) bleeding (none/mucosal/luminal mild/luminal moderate or severe), erosions and ulcers (none/erosions/superficial/deep), each with precise definitions, which explained 90% of the variance (pR(2), Akaike Information Criterion) in the overall assessment of endoscopic severity, predictions varying from 4 to 93 on a 100-point scale (from normal to worst endoscopic severity). The Ulcerative Colitis Endoscopic Index of Severity accurately predicts overall assessment of endoscopic severity of UC. Validity and responsiveness need further testing before it can be applied as an outcome measure in clinical trials or clinical practice.

  2. Lake Whitney Comprehensive Water Quality Assessment, Phase 1B- Physical and Biological Assessment (USDOE)

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

    Doyle, Robert D; Byars, Bruce W

    2009-11-24

    Baylor University Center for Reservoir and Aquatic Systems Research (CRASR) has conducted a phased, comprehensive evaluation of Lake Whitney to determine its suitability for use as a regional water supply reservoir. The area along the Interstate 35 corridor between Dallas / Fort Worth Metroplex and the Waco / Temple Centroplex represents one of the fastest growth areas in the State of Texas and reliable water supplies are critical to sustainable growth. Lake Whitney is situated midway between these two metropolitan areas. Currently, the City of Whitney as well as all of Bosque and Hill counties obtain their potable water frommore » the Trinity Sands aquifer. Additionally, parts of the adjoining McLennan and Burleson counties utilize the Trinity sands aquifer system as a supplement to their surface water supplies. Population growth coupled with increasing demands on this aquifer system in both the Metroplex and Centroplex have resulted in a rapid depletion of groundwater in these rural areas. The Lake Whitney reservoir represents both a potentially local and regional solution for an area experiencing high levels of growth. Because of the large scope of this project as well as the local, regional and national implications, we have designed a multifaceted approach that will lead to the solution of numerous issues related to the feasibility of using Lake Whitney as a water resource to the region. Phase IA (USEPA, QAPP Study Elements 1-4) of this research focused on the physical limnology of the reservoir (bathymetry and fine scale salinity determination) and develops hydrodynamic watershed and reservoir models to evaluate how salinity would be expected to change with varying hydrologic and climatic factors. To this end, we implemented a basic water quality modeling program in collaboration with the Texas Parks and Wildlife Department and the Texas Commission on Environmental Quality to add to the developing long-term database on Lake Whitney. Finally, we conducted an initial assessment of knowledge of watershed and water quality related issues by local residents and stakeholders of Lake Whitney and design an intervention educational program to address any deficiencies discovered. Phase IA was funded primarily from EPA Cooperative Agreement X7-9769 8901-0. Phase IC (USEPA, QAPP Study Element 5) of this research focused on the ambient toxicity of the reservoir with respect to periodic blooms of golden algae. Phase IC was funded primarily from Cooperative Agreement EM-96638001. Phase 1B (USDOE, Study Elements 6-11) complemented work being done via EPA funding on study elements 1-5 and added five new study elements: 6) Salinity Transport in the Brazos Watershed to Lake Whitney; 7) Bacterial Assessment; 8) Organic Contaminant Analysis on Lake Whitney; 9) Plankton Photosynthesis; 10) Lake Whitney Resident Knowledge Assessment; and 11) Engineering Scoping Perspective: Recommendations for Use.« less

  3. Phase-Angle Dependence of Determinations of Diameter, Albedo, and Taxonomy: A Case Study of NEO 3691 Bede

    NASA Technical Reports Server (NTRS)

    Wooden, Diane H.; Lederer, Susan M.; Jehin, Emmanuel; Howell, Ellen S.; Fernandez, Yan; Harker, David E.; Ryan, Erin; Lovell, Amy; Woodward, Charles E.; Benner, Lance A.

    2015-01-01

    Parameters important for NEO risk assessment and mitigation include Near-Earth Object diameter and taxonomic classification, which translates to surface composition. Diameters of NEOs are derived from the thermal fluxes measured by WISE, NEOWISE, Spitzer Warm Mission and ground-based telescopes including the IRTF and UKIRT. Diameter and its coupled parameters Albedo and IR beaming parameter (a proxy for thermal inertia and/or surface roughness) are dependent upon the phase angle, which is the Sun-target-observer angle. Orbit geometries of NEOs, however, typically provide for observations at phase angles greater than 20 degrees. At higher phase angles, the observed thermal emission is sampling both the day and night sides of the NEO. We compare thermal models for NEOs that exclude (NEATM) and include (NESTM) night-side emission. We present a case study of NEO 3691 Bede, which is a higher albedo object, X (Ec) or Cgh taxonomy, to highlight the range of H magnitudes for this object (depending on the albedo and phase function slope parameter G), and to examine at different phase angles the taxonomy and thermal model fits for this NEO. Observations of 3691 Bede include our observations with IRTF+SpeX and with the 10 micrometer UKIRT+Michelle instrument, as well as WISE and Spitzer Warm mission data. By examining 3691 Bede as a case study, we highlight the interplay between the derivation of basic physical parameters and observing geometry, and we discuss the uncertainties in H magnitude, taxonomy assignment amongst the X-class (P, M, E), and diameter determinations. Systematic dependencies in the derivation of basic characterization parameters of H-magnitude, diameter, albedo and taxonomy with observing geometry are important to understand. These basic characterization parameters affect the statistical assessments of the NEO population, which in turn, affects the assignment of statistically-assessed basic parameters to discovered but yet-to-be-fully-characterized NEOs.

  4. Diagnostic performance of dental maturity for identification of skeletal maturation phase.

    PubMed

    Perinetti, G; Contardo, L; Gabrieli, P; Baccetti, T; Di Lenarda, R

    2012-08-01

    The objective of this study is to analyse the diagnostic performance of the circumpubertal dental maturation phases for the identification of individual-specific skeletal maturation phases. A total of 354 healthy subjects, 208 females and 146 males (mean age, 11.1 ± 2.4 years; range, 6.8-17.1 years), were enrolled in the study. Dental maturity was assessed through the calcification stages from panoramic radiographs of the mandibular canine, the first and second premolars, and the second molar. Determination of skeletal maturity was according to the cervical vertebra maturation (CVM) method on lateral cephalograms. Diagnostic performances were evaluated according to the dental maturation stages for each tooth for the identification of the CVM stages and growth phases (as pre-pubertal, pubertal, and post-pubertal) using positive likelihood ratios (LHRs). A positive LHR threshold of 10 or more was considered for satisfactory reliability of any dental maturation stage for the identification of any of the CVM stages or growth phases. The positive LHRs were generally less than 2.0, with a few exceptions. These four teeth showed positive LHRs greater than 10 only for the identification of the pre-pubertal growth phase, with values from 10.8 for the second molar (stage E) to 39.3 for the first premolar (stage E). Dental maturation assessment is only useful for diagnosis of the pre-pubertal growth phase, and thus, precise information in relation to the timing of the onset of the growth spurt is not provided by these indices.

  5. 78 FR 5165 - First Phase of the Forest Planning Process for the Bio-Region

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-24

    ... DEPARTMENT OF AGRICULTURE Forest Service First Phase of the Forest Planning Process for the Bio... initiating the first phase of the forest planning process for the Bio-Region. SUMMARY: Come gather 'round... phase of the Bio-Regional Assessment has begun. DATES: The Bio-Regional Assessment Report will be...

  6. Oropharyngeal dysphagia in preschool children with cerebral palsy: oral phase impairments.

    PubMed

    Benfer, Katherine A; Weir, Kelly A; Bell, Kristie L; Ware, Robert S; Davies, Peter S W; Boyd, Roslyn N

    2014-12-01

    This study aimed to document the prevalence and patterns of oral phase oropharyngeal dysphagia (OPD) in preschool children with cerebral palsy (CP), and its association with mealtime duration, frequency and efficiency. Cross-sectional population-based cohort study of 130 children diagnosed with CP at 18-36 months ca (mean = 27.4 months, 81 males) and 40 children with typical development (mean = 26.2, 18 males). Functional abilities of children with CP were representative of a population sample (GMFCS I = 57, II = 15, III = 23, IV = 12, V = 23). Oral phase impairment was rated from video using the Dyspahgia Disorders Survey, Schedule for Oral Motor Impairment, and Pre-Speech Assessment Scale. Parent-report was collected on a feeding questionnaire. Mealtime frequency, duration and efficiency were calculated from a three day weighed food record completed by parents. Gross motor function was classified using the Gross Motor Function Classification System (GMFCS). Overall, 93.8% of children had directly assessed oral phase impairments during eating or drinking, or in controlling saliva (78.5% with modified cut-points). Directly assessed oral phase impairments were associated with declining gross motor function, with children from GMFCS I having a 2-fold increased likelihood of oral phase impairment compared to the children with TD (OR = 2.0, p = 0.18), and all children from GMFCS II-V having oral phase impairments. Difficulty biting (70%), cleaning behaviours (70%) and chewing (65%) were the most common impairments on solids, and difficulty sipping from a cup (60%) for fluids. OPD severity and GMFCS were not related to mealtime frequency, duration or efficiency, although children on partial tube feeds had significantly reduced mealtime efficiency. Oral phase impairments were common in preschool children with CP, with severity increasing stepwise with declining gross motor function. The prevalence and severity of oral phase impairments were significantly greater for most tasks when compared to children with typical development, even for those with mild CP. Children who were partially tube fed had significantly lower feeding efficiency, so this could be a useful early indicator of children needing supplementation to their nutrition (through increasing energy density of foods/fluids, or tube feeds). Copyright © 2014 Elsevier Ltd. All rights reserved.

  7. Maintenance of a smoking cessation program in public health clinics beyond the experimental evaluation period.

    PubMed Central

    Manfredi, C.; Crittenden, K.; Cho, Y. I.; Engler, J.; Warnecke, R.

    2001-01-01

    OBJECTIVES: As phase 3 of a study to evaluate a smoking cessation program in public health practice, the authors assess the maintenance and impact of the It's Time smoking cessation program in seven public maternal and child health clinics in Chicago. METHODS: The authors interviewed 404 clinic patients in the study's baseline phase (prior to introduction of the It's Time intervention program), and 610 in the program maintenance phase (in the year after experimental evaluation had ended) to assess exposure to smoking cessation interventions offered at the clinic, and smoking cessation outcomes (quit, actions toward quitting, scores on action, motivation, readiness, and confidence scales). The authors controlled for clustering of smokers within clinics, smokers' characteristics prior to clinic visit, and type of clinic service. They compared outcomes by study group (control or intervention) to which each clinic had been assigned in the earlier experimental phase. RESULTS: Compared to baseline, smokers in the maintenance phase had greater exposure to posters, provider advice and booklet, and better outcomes on seven of eight smoking cessation measures, including quitting. These improvements were larger for clinics with prior experience implementing It's Time. CONCLUSION: Participation in the experimental evaluation of the It's Time program prepared and possibly motivated the clinics to continue the program. Continuing the program resulted in greater delivery of interventions and improved smoking cessation outcomes for smokers in the clinics. PMID:11889280

  8. Schema therapy for chronic depression: Results of a multiple single case series.

    PubMed

    Renner, Fritz; Arntz, Arnoud; Peeters, Frenk P M L; Lobbestael, Jill; Huibers, Marcus J H

    2016-06-01

    The aim of this study was to test the effects of individual schema therapy (ST) for patients with chronic depression. Using a multiple-baseline single case series design, patients with chronic major depressive disorder (N = 25) first entered a 6-24 weeks baseline phase; this phase functioned as a no-treatment control condition. Then, patients started a 12 week exploration phase during which symptoms and underlying schemas were explored; this phase functioned as an attention control condition. Next, patients received up to 65 sessions of individual ST. The Beck Depression Inventory II (BDI-II) and the Quick Inventory of Depressive Symptomatology (QIDS) were the primary outcome measures. The BDI-II was assessed once a week during all phases of the study resulting in 100 repeated assessments per participant on average. Mixed regression analysis was used to contrast change in symptoms during the intervention with change in symptoms during the baseline and exploration control phases. When compared to the no-treatment control period, the intervention had a significant, large effect on depressive symptoms (Cohen's d BDI-II = 1.30; Cohen's d QIDS = 1.22). Effects on secondary continuous outcomes were moderate to large. The small sample size and lack of a control group. These findings provide evidence that ST might be an effective treatment for patients with chronic depression. Copyright © 2015 Elsevier Ltd. All rights reserved.

  9. The Maximal Oxygen Uptake Verification Phase: a Light at the End of the Tunnel?

    PubMed

    Schaun, Gustavo Z

    2017-12-08

    Commonly performed during an incremental test to exhaustion, maximal oxygen uptake (V̇O 2max ) assessment has become a recurring practice in clinical and experimental settings. To validate the test, several criteria were proposed. In this context, the plateau in oxygen uptake (V̇O 2 ) is inconsistent in its frequency, reducing its usefulness as a robust method to determine "true" V̇O 2max . Moreover, secondary criteria previously suggested, such as expiratory exchange ratios or percentages of maximal heart rate, are highly dependent on protocol design and often are achieved at V̇O 2 percentages well below V̇O 2max . Thus, an alternative method termed verification phase was proposed. Currently, it is clear that the verification phase can be a practical and sensitive method to confirm V̇O 2max ; however, procedures to conduct it are not standardized across the literature and no previous research tried to summarize how it has been employed. Therefore, in this review the knowledge on the verification phase was updated, while suggestions on how it can be performed (e.g. intensity, duration, recovery) were provided according to population and protocol design. Future studies should focus to identify a verification protocol feasible for different populations and to compare square-wave and multistage verification phases. Additionally, studies assessing verification phases in different patient populations are still warranted.

  10. Cost-effectiveness of PET and PET/computed tomography: a systematic review.

    PubMed

    Gerke, Oke; Hermansson, Ronnie; Hess, Søren; Schifter, Søren; Vach, Werner; Høilund-Carlsen, Poul Flemming

    2015-01-01

    The development of clinical diagnostic procedures comprises early-phase and late-phase studies to elucidate diagnostic accuracy and patient outcome. Economic assessments of new diagnostic procedures compared with established work-ups indicate additional cost for 1 additional unit of effectiveness measure by means of incremental cost-effectiveness ratios when considering the replacement of the standard regimen by a new diagnostic procedure. This article discusses economic assessments of PET and PET/computed tomography reported until mid-July 2014. Forty-seven studies on cancer and noncancer indications were identified but, because of the widely varying scope of the analyses, a substantial amount of work remains to be done. Copyright © 2015 Elsevier Inc. All rights reserved.

  11. Quality of reporting in oncology phase II trials: A 5-year assessment through systematic review

    PubMed Central

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

    2017-01-01

    Background Phase II clinical trials are a cornerstone of the development in experimental treatments They work as a "filter" for phase III trials confirmation. Surprisingly the attrition ratio in Phase III trials in oncology is significantly higher than in any other medical specialty. This suggests phase II trials in oncology fail to achieve their goal. Objective The present study aims at estimating the quality of reporting in published oncology phase II clinical trials. Data sources A literature review was conducted among all phase II and phase II/III clinical trials published during a 5-year period (2010–2015). Study eligibility criteria All articles electronically published by three randomly-selected oncology journals with Impact-Factors>4 were included: Journal of Clinical Oncology, Annals of Oncology and British Journal of Cancer. Intervention Quality of reporting was assessed using the Key Methodological Score. Results 557 articles were included. 315 trials were single-arm studies (56.6%), 193 (34.6%) were randomized and 49 (8.8%) were non-randomized multiple-arm studies. The Methodological Score was equal to 0 (lowest level), 1, 2, 3 (highest level) respectively for 22 (3.9%), 119 (21.4%), 270 (48.5%) and 146 (26.2%) articles. The primary end point is almost systematically reported (90.5%), while sample size calculation is missing in 66% of the articles. 3 variables were independently associated with reporting of a high standard: presence of statistical design (p-value <0.001), multicenter trial (p-value = 0.012), per-protocol analysis (p-value <0.001). Limitations Screening was mainly performed by a sole author. The Key Methodological Score was based on only 3 items, making grey zones difficult to translate. Conclusions & implications of key findings This literature review highlights the existence of gaps concerning the quality of reporting. It therefore raised the question of the suitability of the methodology as well as the quality of these trials, reporting being incomplete in the corresponding articles. PMID:29216190

  12. Development and validation of a brief screening instrument for psychosocial risk associated with genetic testing: a pan-Canadian cohort study

    PubMed Central

    Esplen, Mary Jane; Cappelli, Mario; Wong, Jiahui; Bottorff, Joan L; Hunter, Jon; Carroll, June; Dorval, Michel; Wilson, Brenda; Allanson, Judith; Semotiuk, Kara; Aronson, Melyssa; Bordeleau, Louise; Charlemagne, Nicole; Meschino, Wendy

    2013-01-01

    Objectives To develop a brief, reliable and valid instrument to screen psychosocial risk among those who are undergoing genetic testing for Adult-Onset Hereditary Disease (AOHD). Design A prospective two-phase cohort study. Setting 5 genetic testing centres for AOHD, such as cancer, Huntington's disease or haemochromatosis, in ambulatory clinics of tertiary hospitals across Canada. Participants 141 individuals undergoing genetic testing were approached and consented to the instrument development phase of the study (Phase I). The Genetic Psychosocial Risk Instrument (GPRI) developed in Phase I was tested in Phase II for item refinement and validation. A separate cohort of 722 individuals consented to the study, 712 completed the baseline package and 463 completed all follow-up assessments. Most participants were female, at the mid-life stage. Individuals in advanced stages of the illness or with cognitive impairment or a language barrier were excluded. Interventions Phase I: GPRI items were generated from (1) a review of the literature, (2) input from genetic counsellors and (3) phase I participants. Phase II: further item refinement and validation were conducted with a second cohort of participants who completed the GPRI at baseline and were followed for psychological distress 1-month postgenetic testing results. Primary and secondary outcome measures GPRI, Hamilton Depression Rating Scale (HAM-D), Hamilton Anxiety Rating Scale (HAM-A), Brief Symptom Inventory (BSI) and Impact of Event Scale (IES). Results The final 20-item GPRI had a high reliability—Cronbach's α at 0.81. The construct validity was supported by high correlations between GPRI and BSI and IES. The predictive value was demonstrated by a receiver operating characteristic curve of 0.78 plotting GPRI against follow-up assessments using HAM-D and HAM-A. Conclusions With a cut-off score of 50, GPRI identified 84% of participants who displayed distress postgenetic testing results, supporting its potential usefulness in a clinical setting. PMID:23485718

  13. A Novel Strategy for Continuation ECT in Geriatric Depression: Phase 2 of the PRIDE Study.

    PubMed

    Kellner, Charles H; Husain, Mustafa M; Knapp, Rebecca G; McCall, W Vaughn; Petrides, Georgios; Rudorfer, Matthew V; Young, Robert C; Sampson, Shirlene; McClintock, Shawn M; Mueller, Martina; Prudic, Joan; Greenberg, Robert M; Weiner, Richard D; Bailine, Samuel H; Rosenquist, Peter B; Raza, Ahmad; Kaliora, Styliani; Latoussakis, Vassilios; Tobias, Kristen G; Briggs, Mimi C; Liebman, Lauren S; Geduldig, Emma T; Teklehaimanot, Abeba A; Dooley, Mary; Lisanby, Sarah H

    2016-11-01

    The randomized phase (phase 2) of the Prolonging Remission in Depressed Elderly (PRIDE) study evaluated the efficacy and tolerability of continuation ECT plus medication compared with medication alone in depressed geriatric patients after a successful course of ECT (phase 1). PRIDE was a two-phase multisite study. Phase 1 was an acute course of right unilateral ultrabrief pulse ECT, augmented with venlafaxine. Phase 2 compared two randomized treatment arms: a medication only arm (venlafaxine plus lithium, over 24 weeks) and an ECT plus medication arm (four continuation ECT treatments over 1 month, plus additional ECT as needed, using the Symptom-Titrated, Algorithm-Based Longitudinal ECT [STABLE] algorithm, while continuing venlafaxine plus lithium). The intent-to-treat sample comprised 120 remitters from phase 1. The primary efficacy outcome measure was score on the 24-item Hamilton Depression Rating Scale (HAM-D), and the secondary efficacy outcome was score on the Clinical Global Impressions severity scale (CGI-S). Tolerability as measured by neurocognitive performance (reported elsewhere) was assessed using an extensive test battery; global cognitive functioning as assessed by the Mini-Mental State Examination (MMSE) is reported here. Longitudinal mixed-effects repeated-measures modeling was used to compare ECT plus medication and medication alone for efficacy and global cognitive function outcomes. At 24 weeks, the ECT plus medication group had statistically significantly lower HAM-D scores than the medication only group. The difference in adjusted mean HAM-D scores at study end was 4.2 (95% CI=1.6, 6.9). Significantly more patients in the ECT plus medication group were rated "not ill at all" on the CGI-S compared with the medication only group. There was no statistically significant difference between groups in MMSE score. Additional ECT after remission (here operationalized as four continuation ECT treatments followed by further ECT only as needed) was beneficial in sustaining mood improvement for most patients.

  14. [Combined use of ECK-triggered 2D-phase contrast MR angiography and 2D-time-of-flight MR angiography for planning and follow up before and after vascular intervention of pelvic and leg arteries].

    PubMed

    Reimer, P; Wilhelm, M; Lentschig, M; Wörtler, K; Marx, C; Allkemper, T; Boettger, U; Heinecke, A; Rummeny, E J; Peters, P E

    1998-03-01

    To develop a strategy for the complete work-up of vessel lumen and vessel wall for planning and follow-up of radiological interventions of lower extremity arteries. A total of 36 patients (21 pre-, 8 post- and 7 pre- and postinterventional) were studied. MRA studies were performed using an ECG-triggered phase contrast technique for the demonstration of intraluminal flow and an axial high resolution time-of-flight technique to assess the vascular wall. All MRA studies were analysed by intraindividual DSA comparison for the assessment of flow and wall structures. Combined MRA techniques provided a good correlation with DSA for the assessment of vascular flow. The kappa test revealed a value of greater than 0.61 for most on the vessel segments proving a good correlation of both methods. Orthogonal high-resolution TOF-MRA provided additional information for the assessment postinterventional wall haematomas and hard plaques. Combination of PCA to study flow and axial TOF to study wall pathology improves the usefulness of peripheral MRA.

  15. Assessing long-term hydrologic impact of climate change using ensemble approach and comparison with Global Gridded Model-A case study on Goodwater Creek Experimental Watershed

    USDA-ARS?s Scientific Manuscript database

    Potential impacts of climate change on hydrologic components of Goodwater Creek Experimental Watershed were assessed using climate datasets from the Coupled Model Intercomparison Project Phase 5 and Soil and Water Assessment Tool (SWAT). Historical and future ensembles of downscaled precipitation an...

  16. Active hemorrhage and vascular injuries in splenic trauma: utility of the arterial phase in multidetector CT.

    PubMed

    Uyeda, Jennifer W; LeBedis, Christina A; Penn, David R; Soto, Jorge A; Anderson, Stephan W

    2014-01-01

    To determine whether the addition of arterial phase computed tomography (CT) to the standard combination of portal venous and delayed phase imaging increases sensitivity in the diagnosis of active hemorrhage and/or contained vascular injuries in patients with splenic trauma. The institutional review board approved this HIPAA-compliant retrospective study; the requirement to obtain informed consent was waived. The study included all patients aged 15 years and older who sustained a splenic injury from blunt or penetrating trauma and who underwent CT in the arterial and portal venous phases of image acquisition during a 74-month period (September 2005 to November 2011). CT scans were reviewed by three radiologists, and a consensus interpretation was made to classify the splenic injuries according to the American Association for the Surgery of Trauma splenic injury scale. One radiologist independently recorded the presence of contained vascular injuries or active hemorrhage and the phase or phases at which these lesions were seen. Clinical outcome was assessed by reviewing medical records. The relationship between imaging findings and clinical management was assessed with the Fisher exact test. One hundred forty-seven patients met the inclusion criteria; 32 patients (22%) had active hemorrhage and 22 (15%) had several contained vascular injuries. In 13 of the 22 patients with contained injuries, the vascular lesion was visualized only at the arterial phase of image acquisition; the other nine contained vascular injuries were seen at all phases. Surgery or embolization was performed in 11 of the 22 patients with contained vascular injury. The arterial phase of image acquisition improves detection of traumatic contained splenic vascular injuries and should be considered to optimize detection of splenic injuries in trauma with CT. ©RSNA, 2013.

  17. The efficacy of the Microsoft KinectTM to assess human bimanual coordination.

    PubMed

    Liddy, Joshua J; Zelaznik, Howard N; Huber, Jessica E; Rietdyk, Shirley; Claxton, Laura J; Samuel, Arjmand; Haddad, Jeffrey M

    2017-06-01

    The Microsoft Kinect has been used in studies examining posture and gait. Despite the advantages of portability and low cost, this device has not been used to assess interlimb coordination. Fundamental insights into movement control, variability, health, and functional status can be gained by examining coordination patterns. In this study, we investigated the efficacy of the Microsoft Kinect to capture bimanual coordination relative to a research-grade motion capture system. Twenty-four healthy adults performed coordinated hand movements in two patterns (in-phase and antiphase) at eight movement frequencies (1.00-3.33 Hz). Continuous relative phase (CRP) and discrete relative phase (DRP) were used to quantify the means (mCRP and mDRP) and variability (sdCRP and sdDRP) of coordination patterns. Between-device agreement was assessed using Bland-Altman bias with 95 % limits of agreement, concordance correlation coefficients (absolute agreement), and Pearson correlation coefficients (relative agreement). Modest-to-excellent relative and absolute agreements were found for mCRP in all conditions. However, mDRP showed poor agreement for the in-phase pattern at low frequencies, due to large between-device differences in a subset of participants. By contrast, poor absolute agreement was observed for both sdCRP and sdDRP, while relative agreement ranged from poor to excellent. Overall, the Kinect captures the macroscopic patterns of bimanual coordination better than coordination variability.

  18. Understanding visual search patterns of dermatologists assessing pigmented skin lesions before and after online training.

    PubMed

    Krupinski, Elizabeth A; Chao, Joseph; Hofmann-Wellenhof, Rainer; Morrison, Lynne; Curiel-Lewandrowski, Clara

    2014-12-01

    The goal of this investigation was to explore the feasibility of characterizing the visual search characteristics of dermatologists evaluating images corresponding to single pigmented skin lesions (PSLs) (close-ups and dermoscopy) as a venue to improve training programs for dermoscopy. Two Board-certified dermatologists and two dermatology residents participated in a phased study. In phase I, they viewed a series of 20 PSL cases ranging from benign nevi to melanoma. The close-up and dermoscopy images of the PSL were evaluated sequentially and rated individually as benign or malignant, while eye position was recorded. Subsequently, the participating subjects completed an online dermoscopy training module that included a pre- and post-test assessing their dermoscopy skills (phase 2). Three months later, the subjects repeated their assessment on the 20 PSLs presented during phase I of the study. Significant differences in viewing time and eye-position parameters were observed as a function of level of expertise. Dermatologists overall have more efficient search than residents generating fewer fixations with shorter dwells. Fixations and dwells associated with decisions changing from benign to malignant or vice versa from photo to dermatoscopic viewing were longer than any other decision, indicating increased visual processing for those decisions. These differences in visual search may have implications for developing tools to teach dermatologists and residents about how to better utilize dermoscopy in clinical practice.

  19. Long-Term Safety and Efficacy of Fulranumab in Patients With Moderate-to-Severe Osteoarthritis Pain: A Phase II Randomized, Double-Blind, Placebo-Controlled Extension Study.

    PubMed

    Sanga, Panna; Katz, Nathaniel; Polverejan, Elena; Wang, Steven; Kelly, Kathleen M; Haeussler, Juergen; Thipphawong, John

    2017-04-01

    To evaluate the long-term safety and efficacy of fulranumab in patients with knee or hip pain caused by moderate-to-severe chronic osteoarthritis (OA). In this phase II double-blind, placebo-controlled extension study, patients who were randomized in equal proportions to receive subcutaneous doses of either placebo or fulranumab (1 mg every 4 weeks, 3 mg every 8 weeks, 3 mg every 4 weeks, 6 mg every 8 weeks, or 10 mg every 8 weeks) in the 12-week double-blind efficacy phase and who completed this double-blind efficacy phase were eligible to continue the dosage throughout a 92-week double-blind extension phase, followed by a 24-week posttreatment follow-up period. Safety assessments included evaluation of treatment-emergent adverse events (TEAEs), pre-identified AEs of interest, and joint replacements. Efficacy assessments included changes from baseline to the end of the double-blind extension phase in scores on the patient's global assessment and the pain and physical function subscales of the Western Ontario and McMaster Universities Osteoarthritis Index. Overall, 401 of the 423 patients who completed the 12-week double-blind efficacy phase entered the extension study. Long-term sustained improvements were observed in all efficacy parameters following fulranumab treatment (1 mg every 4 weeks, 3 mg every 4 weeks, and 10 mg every 8 weeks) as compared with placebo. Similar percentages of patients in both groups experienced TEAEs (88% taking placebo and 91% taking fulranumab; all phases). Across all fulranumab groups, arthralgia (21%) and OA (18%) (e.g., exacerbation of OA pain) were the most common TEAEs. The most common serious TEAEs were the requirement for knee (10%) and hip (7%) arthroplasty, with 80% occurring during the posttreatment follow-up period. Neurologic-related TEAEs (28%; all phases) were generally mild-to-moderate. Overall, 81 joint replacements were performed in 71 patients (8 [11%] receiving placebo and 63 [89%] receiving fulranumab); 15 patients (21%) had rapid progression of OA (RPOA). All cases of RPOA occurred in fulranumab-treated patients who were concurrently receiving nonsteroidal antiinflammatory drugs and occurred in joints with preexisting OA. Long-term treatment with fulranumab was generally well-tolerated and efficacious. RPOA was observed as a safety signal. Future studies are warranted to demonstrate whether the risk of RPOA can be reduced in patients taking fulranumab. © 2016, American College of Rheumatology.

  20. A test-bed modeling study for wave resource assessment

    NASA Astrophysics Data System (ADS)

    Yang, Z.; Neary, V. S.; Wang, T.; Gunawan, B.; Dallman, A.

    2016-02-01

    Hindcasts from phase-averaged wave models are commonly used to estimate standard statistics used in wave energy resource assessments. However, the research community and wave energy converter industry is lacking a well-documented and consistent modeling approach for conducting these resource assessments at different phases of WEC project development, and at different spatial scales, e.g., from small-scale pilot study to large-scale commercial deployment. Therefore, it is necessary to evaluate current wave model codes, as well as limitations and knowledge gaps for predicting sea states, in order to establish best wave modeling practices, and to identify future research needs to improve wave prediction for resource assessment. This paper presents the first phase of an on-going modeling study to address these concerns. The modeling study is being conducted at a test-bed site off the Central Oregon Coast using two of the most widely-used third-generation wave models - WaveWatchIII and SWAN. A nested-grid modeling approach, with domain dimension ranging from global to regional scales, was used to provide wave spectral boundary condition to a local scale model domain, which has a spatial dimension around 60km by 60km and a grid resolution of 250m - 300m. Model results simulated by WaveWatchIII and SWAN in a structured-grid framework are compared to NOAA wave buoy data for the six wave parameters, including omnidirectional wave power, significant wave height, energy period, spectral width, direction of maximum directionally resolved wave power, and directionality coefficient. Model performance and computational efficiency are evaluated, and the best practices for wave resource assessments are discussed, based on a set of standard error statistics and model run times.

  1. Prediction of peak shape in hydro-organic and micellar-organic liquid chromatography as a function of mobile phase composition.

    PubMed

    Baeza-Baeza, J J; Ruiz-Angel, M J; García-Alvarez-Coque, M C

    2007-09-07

    A simple model is proposed that relates the parameters describing the peak width with the retention time, which can be easily predicted as a function of mobile phase composition. This allows the further prediction of peak shape with global errors below 5%, using a modified Gaussian model with a parabolic variance. The model is useful in the optimisation of chromatographic resolution to assess an eventual overlapping of close peaks. The dependence of peak shape with mobile phase composition was studied for mobile phases containing acetonitrile in the presence and absence of micellised surfactant (micellar-organic and hydro-organic reversed-phase liquid chromatography, RPLC). In micellar RPLC, both modifiers (surfactant and acetonitrile) were observed to decrease or improve the efficiencies in the same percentage, at least in the studied concentration ranges. The study also revealed that the problem of achieving smaller efficiencies in this chromatographic mode, compared to hydro-organic RPLC, is not only related to the presence of surfactant covering the stationary phase, but also to the smaller concentration of organic solvent in the mobile phase.

  2. The Next Phase.

    ERIC Educational Resources Information Center

    Oualline, John; Rabenaldt, Carl

    2002-01-01

    Discusses how phased facility assessments, rather than one comprehensive assessment, may be an answer to identifying and addressing capital renewal and deferred maintenance. Presents a table outlining the facility assessment levels and attendant measurement methods. (EV)

  3. Treating verbal working memory in a boy with intellectual disability

    PubMed Central

    Orsolini, Margherita; Melogno, Sergio; Latini, Nausica; Penge, Roberta; Conforti, Sara

    2015-01-01

    The present case study investigates the effects of a cognitive training of verbal working memory that was proposed for Davide, a 14-year-old boy diagnosed with mild intellectual disability. The program stimulated attention, inhibition, switching, and the ability to engage either in verbal dual tasks or in producing inferences after the content of a short passage had been encoded in episodic memory. Key elements in our program included (1) core training of target cognitive mechanisms; (2) guided practice emphasizing concrete strategies to engage in exercises; and (3) a variable amount of adult support. The study explored whether such a complex program produced “near transfer” effects on an untrained dual task assessing verbal working memory and whether effects on this and other target cognitive mechanisms (i.e., attention, inhibition, and switching) were long-lasting and produced “far transfer” effects on cognitive flexibility. The effects of the intervention program were investigated with a research design consisting of four subsequent phases lasting 8 or 10 weeks, each preceded and followed by testing. There was a control condition (phase 1) in which the boy received, at home, a stimulation focused on the visuospatial domain. Subsequently, there were three experimental training phases, in which stimulation in the verbal domain was first focused on attention and inhibition (phase 2a), then on switching and simple working memory tasks (phase 2b), then on complex working memory tasks (phase 3). A battery of neuropsychological tests was administered before and after each training phase and 7 months after the conclusion of the intervention. The main finding was that Davide changed from being incapable of addressing the dual task request of the listening span test in the initial assessment to performing close to the normal limits of a 13-year-old boy in the follow-up assessment with this test, when he was 15 years old. PMID:26284014

  4. Developing a pilot curriculum to foster humanism among graduate medical trainees.

    PubMed

    Dotters-Katz, Sarah K; Chuang, Alice; Weil, Amy; Howell, Jennifer O

    2018-01-01

    Humanism is a central tenant of professionalism, a required competency for all residency programs. Yet, few residencies have formal curriculum for teaching this critical aspect of medicine. Instead, professionalism and humanism are often taught informally through role-modeling. With increased burnout, faculty professionalism may suffer and may compromise resident role-modeling. The objective of this study was to design a pilot curriculum to foster humanism in among residents and assess its ability to do so. Two-phase exploratory sequential mixed methods study. Phase 1: a qualitative analysis of residents' narratives regarding challenges to humanistic behavior, and identified themes of compassion, fatigue, communication challenges, and work-life balance. Themes used as needs assessment to build curriculum. Phase 2: three sessions with themes taken from faculty development course. Participants and controls completed baseline and 60-day follow-up questionnaires assessing burnout, compassion, satisfaction, and ability to practice psychological medicine. Phase one included Obstetrics/Gynecology and internal medicine residents. Phase two included residents from the above programs, who attended at least 2/3 interactive sessions designed to address the themes identified above. Twelve participants began and ten completed curriculum (83%). The curriculum met course objectives and was well-received (4.8/5). Burnout decreased (-3.1 vs. 2.5, P = 0.048). A trend toward improved compassion (4.4 vs.-0.6, P = 0.096) for participants compared to controls was noted. A pilot humanism curriculum for residents was well-received. Participants showed decreased burnout and trended to improved compassion scores. Development and evaluation of an expanded curriculum would further explore feasibility and effectiveness of the intervention.

  5. Rational Clinical Experiment: Assessing Prior Probability and Its Impact on the Success of Phase II Clinical Trials

    PubMed Central

    Halperin, Daniel M.; Lee, J. Jack; Dagohoy, Cecile Gonzales; Yao, James C.

    2015-01-01

    Purpose Despite a robust clinical trial enterprise and encouraging phase II results, the vast minority of oncologic drugs in development receive regulatory approval. In addition, clinicians occasionally make therapeutic decisions based on phase II data. Therefore, clinicians, investigators, and regulatory agencies require improved understanding of the implications of positive phase II studies. We hypothesized that prior probability of eventual drug approval was significantly different across GI cancers, with substantial ramifications for the predictive value of phase II studies. Methods We conducted a systematic search of phase II studies conducted between 1999 and 2004 and compared studies against US Food and Drug Administration and National Cancer Institute databases of approved indications for drugs tested in those studies. Results In all, 317 phase II trials were identified and followed for a median of 12.5 years. Following completion of phase III studies, eventual new drug application approval rates varied from 0% (zero of 45) in pancreatic adenocarcinoma to 34.8% (24 of 69) for colon adenocarcinoma. The proportion of drugs eventually approved was correlated with the disease under study (P < .001). The median type I error for all published trials was 0.05, and the median type II error was 0.1, with minimal variation. By using the observed median type I error for each disease, phase II studies have positive predictive values ranging from less than 1% to 90%, depending on primary site of the cancer. Conclusion Phase II trials in different GI malignancies have distinct prior probabilities of drug approval, yielding quantitatively and qualitatively different predictive values with similar statistical designs. Incorporation of prior probability into trial design may allow for more effective design and interpretation of phase II studies. PMID:26261263

  6. SUPERFUND TREATABILITY CLEARINGHOUSE: FINAL REPORT, PHASE I - IMMEDIATE ASSESSMENT, ACME SOLVENTS SITE

    EPA Science Inventory

    This is a site assessment and feasibility study of incineration alternatives at the ACME Solvents Site at Rockford, Illinois. The document contains laboratory results that are reported to simulate incineration conditions but no details on test methods were provided. The d...

  7. Phase I Trial of Anti-MET Monoclonal Antibody in MET-Overexpressed Refractory Cancer.

    PubMed

    Lee, Jeeyun; Kim, Seung Tae; Park, Sungju; Lee, Sujin; Park, Se Hoon; Park, Joon Oh; Lim, Ho Yeong; Ahn, Hongmo; Bok, Haesook; Kim, Kyoung-Mee; Ahn, Myung Ju; Kang, Won Ki; Park, Young Suk

    2018-06-01

    Samsung Advance Institute of Technology-301 (SAIT301) is a human immunoglobulin G2 antibody that can specifically target mesenchymal epithelial transition factor (c-MET). This novel antibody has higher priority over hepatocyte growth factors when binding to the Sema domain of c-MET and accelerates the internalization and degradation of c-MET, proving its powerful antitumor activities in intra- as well as extracellular areas. SAIT301 was administered intravenously once every 3 weeks in c-MET overexpressed solid tumor patients, focusing on metastatic colorectal cancer (CRC) according to common clinical phase I criteria. Dose escalation was performed according to a modified Fibonacci design, following the conventional 3+3 design. The purpose of this phase I study was to assess the safety profile, to establish the recommended dose for clinical phase II studies and to assess potential anticancer activity of the compound. Sixteen patients with a median age of 56 (range, 39-69) years were enrolled in the study. The most common adverse events were decreased appetite (50.0%), hypophosphatemia, fatigue and dizziness (25.0%, respectively), and diarrhea, blood alkaline phosphatase increased and dyspnea (18.8%, respectively). For tumor response, no patients achieved complete response. One (9.1%) CRC patient had a partial response in the 1.23 mg/kg group, 4 (36.4%) patients achieved stable disease (2 in the 0.41 mg/kg group, 2 in the 1.23 mg/kg group, 0 in the 3.69 mg/kg group, and 1 in the 8.61 mg/kg group). Because of the increase in dose-limiting toxicities (DLTs) at 8.61 mg/kg, the 3.69 mg/kg dose was considered the maximum tolerated dose and selected for further assessment in phase II. We successfully completed a phase I trial with MET antibody in a MET-overexpressed patient population focusing on CRC, and found that the DLTs were alkaline phosphatase elevation or hypophosphatemia. The recommended dose of SAIT301 for phase II is the dose of 3.69 mg/kg. Copyright © 2018 Elsevier Inc. All rights reserved.

  8. Needs for Robotic Assessments of Nuclear Disasters

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

    Victor Walker; Derek Wadsworth

    Following the nuclear disaster at the Fukushima nuclear reactor plant in Japan, the need for systems which can assist in dynamic high-radiation environments such as nuclear incidents has become more apparent. The INL participated in delivering robotic technologies to Japan and has identified key components which are needed for success and obstacles to their deployment. In addition, we are proposing new work and methods to improve assessments and reactions to such events in the future. Robotics needs in disaster situations include phases such as: Assessment, Remediation, and Recovery Our particular interest is in the initial assessment activities. In assessment wemore » need collection of environmental parameters, determination of conditions, and physical sample collection. Each phase would require key tools and efforts to develop. This includes study of necessary sensors and their deployment methods, the effects of radiation on sensors and deployment, and the development of training and execution systems.« less

  9. Extractive biodegradation and bioavailability assessment of phenanthrene in the cloud point system by Sphingomonas polyaromaticivorans.

    PubMed

    Pan, Tao; Deng, Tao; Zeng, Xinying; Dong, Wei; Yu, Shuijing

    2016-01-01

    The biological treatment of polycyclic aromatic hydrocarbons is an important issue. Most microbes have limited practical applications because of the poor bioavailability of polycyclic aromatic hydrocarbons. In this study, the extractive biodegradation of phenanthrene by Sphingomonas polyaromaticivorans was conducted by introducing the cloud point system. The cloud point system is composed of a mixture of (40 g/L) Brij 30 and Tergitol TMN-3, which are nonionic surfactants, in equal proportions. After phenanthrene degradation, a higher wet cell weight and lower phenanthrene residue were obtained in the cloud point system than that in the control system. According to the results of high-performance liquid chromatography, the residual phenanthrene preferred to partition from the dilute phase into the coacervate phase. The concentration of residual phenanthrene in the dilute phase (below 0.001 mg/L) is lower than its solubility in water (1.18 mg/L) after extractive biodegradation. Therefore, dilute phase detoxification was achieved, thus indicating that the dilute phase could be discharged without causing phenanthrene pollution. Bioavailability was assessed by introducing the apparent logP in the cloud point system. Apparent logP decreased significantly, thus indicating that the bioavailability of phenanthrene increased remarkably in the system. This study provides a potential application of biological treatment in water and soil contaminated by phenanthrene.

  10. Phase 0/I/II Cancer Prevention Clinical Trials Program (Consortia) | Division of Cancer Prevention

    Cancer.gov

    Five cancer research centers lead multiple collaborative networks to assess potential cancer preventive agents and to conduct early clinical development of promising preventive agents. Also called the Consortia for Early Phase Prevention Trials, the studies require extensive biomarker analysis, investigation of the biologic effects of the cancer preventive agents on their

  11. Worse than Sticks and Stones? Bullying Is Associated with Altered HPA Axis Functioning and Poorer Health

    ERIC Educational Resources Information Center

    Knack, Jennifer M.; Jensen-Campbell, Lauri A.; Baum, Andrew

    2011-01-01

    Adolescents (N = 107; M = 12.23 years, SD = 1.09 months) participated in a two-part study examining peer victimization, neuroendocrine functioning, and physical health. In phase 1, adolescents completed questionnaires assessing peer victimization and health. They returned for phase 2 which consisted of two sessions. In session 1, adolescents…

  12. Configuration study for a 30 GHz monolithic receive array: Technical assessment

    NASA Technical Reports Server (NTRS)

    Nester, W. H.; Cleaveland, B.; Edward, B.; Gotkis, S.; Hesserbacker, G.; Loh, J.; Mitchell, B.

    1984-01-01

    The current status of monolithic microwave integrated circuits (MMICs) in phased array feeds is discussed from the point of view of cost performance, reliability, and design considerations. Transitions to MMICs, compatible antenna radiating elements and reliability considerations are addressed. Hybrid antennas, feed array antenna technology, and offset reflectors versus phased arrays are examined.

  13. Teacher Aptitudes, Knowledge, Attitudes, and Cognitive Style as Predictors of Teaching Behavior.

    ERIC Educational Resources Information Center

    Ekstrom, Ruth B.

    The Beginning Teacher Evaluation Study, Phase II, was a research project on effective teaching behavior--what teachers do that significantly affects what and how pupils learn. The purposes of Phase II were to (1) develop an assessment system for measuring teacher and student behaviors and other factors which could influence each of them and their…

  14. Development of an instrument measuring the perceived attributes of implementing a healthy diet innovation in the Lower Mississippi Delta

    USDA-ARS?s Scientific Manuscript database

    The purpose of this research was to develop a valid and reliable instrument to assess individuals' perceived attributes of implementing a healthy diet. Using the Diffusion of Innovations (DOI) theory as a conceptual framework, this descriptive study consisted of three phases. Phase 1 included group ...

  15. Health-Related Intensity Profiles of Physical Education Classes at Different Phases of the Teaching/Learning Process

    ERIC Educational Resources Information Center

    Bronikowski, Michal; Bronikowska, Malgorzata; Kantanista, Adam; Ciekot, Monika; Laudanska-Krzeminska, Ida; Szwed, Szymon

    2009-01-01

    Study aim: To assess the intensities of three types of physical education (PE) classes corresponding to the phases of the teaching/learning process: Type 1--acquiring and developing skills, Type 2--selecting and applying skills, tactics and compositional principles and Type 3--evaluating and improving performance skills. Material and methods: A…

  16. Guiding Biliteracy Development: Appropriating Cross-Linguistic and Conceptual Knowledge to Sustain Second-Language Reading Comprehension

    ERIC Educational Resources Information Center

    Soto Huerta, Mary Esther

    2012-01-01

    To examine the second-language reading development of 45 fourth-grade Latino bilinguals, a sequential mixed methods study was conducted in two phases (Creswell, 2009). The quantitative data collected in the first phase generated an index of the group's reading performance based on two grade-level assessments, a state-mandated standardized reading…

  17. Treatment of chronic myelogenous leukemia with interleukin-2: a phase II study in 21 patients.

    PubMed

    Vey, N; Blaise, D; Lafage, M; Olive, D; Viens, P; Baume, D; Camerlo, J; Stoppa, A M; Gabus, R; Brandely, M; Hercend, T; Maraninchi, D

    1999-03-01

    We designed a phase II study to assess the activity of recombinant interleukin-2 (rIL-2) in patients with chronic myelogenous leukemia (CML). Study population included 11 patients in the chronic phase of CML (6 in hematologic remission and 5 with active disease), 6 patients in the accelerated phase, and 4 in blastic phase of CML. Patients received three 5-day cycles administrated every other week. rIL-2 was given as intravenous bolus infusions of 8 x 10(6) IU/m2 three times a day during cycle 1 and twice a day during cycles 2 and 3. Response to rIL-2 was assessed on day 45. No hematologic response was achieved in the patients with evaluable disease. One patient in hematologic remission with rIL-2 achieved a major response (from 72% to 9% Ph+ metaphases), and two patients had some degree of reduction of Ph+ metaphases. Responses were short-lived (< 6 months), but two of these three patients achieved a new cytogenetic response with interferon given post-rIL-2. A significant immune activation was achieved with rIL-2 including a marked increase in CD3+/CD25+ cells, CD56+ cells, and in natural killer/lymphokine activated killer cell cytotoxic activity. These results confirm preclinical studies, which showed that IL-2 has antileukemic activity in CML. However, the responses observed were short lived and restricted to a subgroup of patients with low disease burden. This invites further studies testing its impact in situations of minimal disease or in combination with other cytokines.

  18. Effect of head group orientation on phospholipid assembly

    NASA Astrophysics Data System (ADS)

    Paul, Tanay; Saha, Jayashree

    2017-06-01

    The relationship between bilayer stability and lipid head group orientation is reported. In this work, molecular-dynamics simulations are performed to analyze the structure-property relationship of lipid biomembranes, taking into account coarse-grained model lipid interactions. The work explains the molecular scale mechanism of the phase behavior of lipid systems due to ion-lipid or anesthetic-lipid interactions, where reorientations of dipoles play a key role in modifying lipid phases and thereby alter biomembrane function. Our study demonstrates that simple dipolar reorientation is indeed sufficient in tuning a bilayer to a randomly flipped nonbilayer lamellar phase. This study may be used to assess the impact of changes in lipid phase characteristics on biomembrane structure due to the presence of anesthetics and ions.

  19. Clinical Evaluation of a Novel Intrarectal Device for Management of Fecal Incontinence in Bedridden Patients.

    PubMed

    Singh, Sandeep; Bhargava, Balram; Vasantha, Padma; Bhatia, Rohit; Sharma, Hanish; Pal, Sujoy; Sahni, Peush; Makharia, Govind K

    The primary objective of the study was to evaluate the safety and efficacy of a stool management kit (SMK) for containment of fecal incontinence in hospitalized bedridden patients. A single-group quasi-experimental study. Twenty bedridden adults who had at least 1 episode of fecal incontinence in the prior 24 hours participated in the study. The study setting was the neurological unit of the All India Institute of Medical Sciences in New Delhi, India. The study was carried out in 2 phases. The device was placed in situ for up to 24 hours in 10 patients during phase I of the study and up to 120 hours in an additional 10 patients during phase II. Participants were assessed for anorectal injury and peripheral device leakage on a 4- to 6-hourly basis. Sigmoidoscopy was performed to evaluate for any mucosal trauma or alteration of anorectal pathology after retrieval of the device. The device was successfully placed in all patients following the first attempt to place the device; 80% of patients retained the device until planned removal. The SMK diverted fecal matter without anal leakage in 174 (93.5%) out of 186 assessment points in a group of 20 patients. The devices remained in situ for 21 ± 0.2 and 84.5 ± 38.9 hours during phase I and phase II, respectively. None experienced anorectal bleeding, sphincter injury, or mucosal ulceration with device usage. Post-device sigmoidoscopy revealed erythema at the site of diverter placement in 2 participants. Study findings suggest that the SMK successfully diverted liquid to semiformed fecal exudate without peripheral device leakage in 93.5% of bedridden patients. No serious adverse events occurred. Additional research is needed to compare its effectiveness with that of currently available intrarectal balloon devices.

  20. Simulation modeling for stratified breast cancer screening - a systematic review of cost and quality of life assumptions.

    PubMed

    Arnold, Matthias

    2017-12-02

    The economic evaluation of stratified breast cancer screening gains momentum, but produces also very diverse results. Systematic reviews so far focused on modeling techniques and epidemiologic assumptions. However, cost and utility parameters received only little attention. This systematic review assesses simulation models for stratified breast cancer screening based on their cost and utility parameters in each phase of breast cancer screening and care. A literature review was conducted to compare economic evaluations with simulation models of personalized breast cancer screening. Study quality was assessed using reporting guidelines. Cost and utility inputs were extracted, standardized and structured using a care delivery framework. Studies were then clustered according to their study aim and parameters were compared within the clusters. Eighteen studies were identified within three study clusters. Reporting quality was very diverse in all three clusters. Only two studies in cluster 1, four studies in cluster 2 and one study in cluster 3 scored high in the quality appraisal. In addition to the quality appraisal, this review assessed if the simulation models were consistent in integrating all relevant phases of care, if utility parameters were consistent and methodological sound and if cost were compatible and consistent in the actual parameters used for screening, diagnostic work up and treatment. Of 18 studies, only three studies did not show signs of potential bias. This systematic review shows that a closer look into the cost and utility parameter can help to identify potential bias. Future simulation models should focus on integrating all relevant phases of care, using methodologically sound utility parameters and avoiding inconsistent cost parameters.

  1. Multicenter clinical trial of a home-use nonablative fractional laser device for wrinkle reduction.

    PubMed

    Leyden, James; Stephens, Thomas J; Herndon, James H

    2012-11-01

    Until now, nonablative fractional treatments could only be delivered in an office setting by trained professionals. The goal of this work was to perform clinical testing of a nonablative fractional laser device designed for home-use. This multicenter trial consisted of two clinical studies with slightly varying treatment protocols in which subjects performed at-home treatments of periorbital wrinkles using a handheld nonablative fractional laser. Both studies included an active treatment phase (daily treatments) and a maintenance phase (twice-weekly treatments). In all, 36 subjects were followed up for as long as 5 months after completion of the maintenance phase and 90 subjects were followed up until the completion of the maintenance phase. Evaluations included in-person investigator assessment, independent blinded review of high-resolution images using the Fitzpatrick Wrinkle Scale, and subject self-assessment. All 124 subjects who completed the study were able to use the device following written instructions for use. Treatments were well tolerated with good protocol compliance. Independent blinded evaluations by a panel of physicians showed Fitzpatrick Wrinkle Scale score improvement by one or more grades in 90% of subjects at the completion of the active phase and in 79% of subjects at the completion of the maintenance phase. The most prevalent side effect was transient posttreatment erythema. Lack of a control group and single-blinded study groups were limitations. Safety testing with self-applications by users demonstrated the utility of the device for home use. Independent blinded review of clinical images confirmed the device's proficiency for improving periorbital wrinkles. Copyright © 2012 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

  2. Phase Transitions in Antibody Solutions: from Pharmaceuticals to Human Disease

    NASA Astrophysics Data System (ADS)

    Wang, Ying; Lomakin, Aleksey; Benedek, George; Dana Farber Cancer Institute Collaboration; Amgen Inc. Collaboration

    2014-03-01

    Antibodies are very important proteins. Natural antibodies play essential role in the immune system of human body. Pharmaceutical antibodies are used as drugs. Antibodies are also indispensable tools in biomedical research and diagnostics. Recently, a number of observations of phase transitions of pharmaceutical antibodies have been reported. These phase transitions are undesirable from the perspective of colloid stability of drug solutions in processing and storage, but can be used for protein purification, X-ray crystallography, and improving pharmokinetics of drugs. Phase transitions of antibodies can also take place in human body, particularly in multiple myeloma patients who overproduce monoclonal antibodies. These antibodies, in some cases, crystallize at body temperature and cause severe complications called cryoglobulinemia. I will present the results of our current studies on phase transitions of both pharmaceutical antibodies and cryoglobulinemia-associated antibodies. These studies have shown that different antibodies have different propensity to undergo phase transitions, but their phase behavior has universal features which are remarkably different from those of spherical proteins. I will discuss how studies of phase behavior can be useful in assessing colloid stability of pharmaceutical antibodies and in early diagnostics of cryoglobulinemia, as well as general implications of the fact that some antibodies can precipitate at physiological conditions.

  3. Implementation of Systematic Review Tools in IRIS | Science ...

    EPA Pesticide Factsheets

    Currently, the number of chemicals present in the environment exceeds the ability of public health scientists to efficiently screen the available data in order to produce well-informed human health risk assessments in a timely manner. For this reason, the US EPA’s Integrated Risk Information System (IRIS) program has started implementing new software tools into the hazard characterization workflow. These automated tools aid in multiple phases of the systematic review process including scoping and problem formulation, literature search, and identification and screening of available published studies. The increased availability of these tools lays the foundation for automating or semi-automating multiple phases of the systematic review process. Some of these software tools include modules to facilitate a structured approach to study quality evaluation of human and animal data, although approaches are generally lacking for assessing complex mechanistic information, in particular “omics”-based evidence tools are starting to become available to evaluate these types of studies. We will highlight how new software programs, online tools, and approaches for assessing study quality can be better integrated to allow for a more efficient and transparent workflow of the risk assessment process as well as identify tool gaps that would benefit future risk assessments. Disclaimer: The views expressed here are those of the authors and do not necessarily represent the view

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

    Dafler, J.R.; Sinnott, J.; Novil, M.

    The first phase of a study to identify candidate processes and products suitable for future exploitation using high-temperature solar energy is presented. This phase has been principally analytical, consisting of techno-economic studies, thermodynamic assessments of chemical reactions and processes, and the determination of market potentials for major chemical commodities that use significant amounts of fossil resources today. The objective was to identify energy-intensive processes that would be suitable for the production of chemicals and fuels using solar energy process heat. Of particular importance was the comparison of relative costs and energy requirements for the selected solar product versus costs formore » the product derived from conventional processing. The assessment methodology used a systems analytical approach to identify processes and products having the greatest potential for solar energy-thermal processing. This approach was used to establish the basis for work to be carried out in subsequent phases of development. It has been the intent of the program to divide the analysis and process identification into the following three distinct areas: (1) process selection, (2) process evaluation, and (3) ranking of processes. Four conventional processes were selected for assessment namely, methanol synthesis, styrene monomer production, vinyl chloride monomer production, and terephthalic acid production.« less

  5. LV dyssynchrony as assessed by phase analysis of gated SPECT myocardial perfusion imaging in patients with Wolff-Parkinson-White syndrome

    PubMed Central

    Chen, Chun; Miao, Changqing; Feng, Jianlin; Zhou, Yanli; Cao, Kejiang; Lloyd, Michael S.; Chen, Ji

    2013-01-01

    Purpose The purpose of this study was to evaluate left ventricular (LV) mechanical dyssynchrony in patients with Wolff-Parkinson-White (WPW) syndrome pre- and post-radiofrequency catheter ablation (RFA) using phase analysis of gated single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI). Methods Forty-five WPW patients were enrolled and had gated SPECT MPI pre- and 2–3 days post-RFA. Electrophysiological study (EPS) was used to locate accessory pathways (APs) and categorize the patients according to the AP locations (septal, left and right free wall). Electrocardiography (ECG) was performed pre- and post-RFA to confirm successful elimination of the APs. Phase analysis of gated SPECT MPI was used to assess LV dyssynchrony pre- and post-RFA. Results Among the 45 patients, 3 had gating errors, and thus 42 had SPECT phase analysis. Twenty-two patients (52.4 %) had baseline LV dyssynchrony. Baseline LV dyssynchrony was more prominent in the patients with septal APs than in the patients with left or right APs (p<0.05). RFA improved LV synchrony in the entire cohort and in the patients with septal APs (p<0.01). Conclusion Phase analysis of gated SPECT MPI demonstrated that LV mechanical dyssynchrony can be present in patients with WPW syndrome. Septal APs result in the greatest degree of LV mechanical dyssynchrony and afford the most benefit after RFA. This study supports further investigation in the relationship between electrical and mechanical activation using EPS and phase analysis of gated SPECT MPI. PMID:22532253

  6. Technical and Economic Assessment of Span-Loaded Cargo Aircraft Concepts

    NASA Technical Reports Server (NTRS)

    1976-01-01

    The benefits are assessed of span distributed loading concepts as applied to future commercial air cargo operations. A two phased program is used to perform this assessment. The first phase consists of selected parametric studies to define significant configuration, performance, and economic trends. The second phase consists of more detailed engineering design, analysis, and economic evaluations to define the technical and economic feasibility of a selected spanloader design. A conventional all-cargo aircraft of comparable technology and size is used as a comparator system. The technical feasibility is demonstrated of the spanloader concept with no new major technology efforts required to implement the system. However, certain high pay-off technologies such as winglets, airfoil design, and advanced structural materials and manufacturing techniques need refinement and definition prior to application. In addition, further structural design analysis could establish the techniques and criteria necessary to fully capitalize upon the high degree of structural commonality and simplicity inherent in the spanloader concept.

  7. Telemedicine spirometry training and quality assurance program in primary care centers of a public health system.

    PubMed

    Marina Malanda, Nuria; López de Santa María, Elena; Gutiérrez, Asunción; Bayón, Juan Carlos; Garcia, Larraitz; Gáldiz, Juan B

    2014-04-01

    Forced spirometry is essential for diagnosing respiratory diseases and is widely used across levels of care. However, several studies have shown that spirometry quality in primary care is not ideal, with risks of misdiagnosis. Our objective was to assess the feasibility and performance of a telemedicine-based training and quality assurance program for forced spirometry in primary care. The two phases included (1) a 9-month pilot study involving 15 centers, in which spirometry tests were assessed by the Basque Office for Health Technology Assessment, and (2) the introduction of the program to all centers in the Public Basque Health Service. Technicians first received 4 h of training, and, subsequently, they sent all tests to the reference laboratory using the program. Quality assessment was performed in accordance with clinical guidelines (A and B, good; C-F, poor). In the first phase, 1,894 spirometry tests were assessed, showing an improvement in quality: acceptable quality tests increased from 57% at the beginning to 78% after 6 months and 83% after 9 months (p<0.001). In the second phase, 7,200 spirometry tests were assessed after the inclusion of 36 additional centers, maintaining the positive trend (61%, 87%, and 84% at the same time points; p<0.001). (1) The quality of spirometry tests improved in all centers. (2) The program provides a tool for transferring data that allows monitoring of its quality and training of technicians who perform the tests. (3) This approach is useful for improving spirometry quality in the routine practice of a public health system.

  8. Health status assessment of workers during construction phase of highway rehabilitation projects around lahore, Pakistan.

    PubMed

    Abrar, Amina; Cheema, Kausar Jamal; Saif, Samia; Mahmood, Asim

    2017-01-24

    The study focused on assessment of the health status of workers during construction phase of highway rehabilitation projects at six selected sites of N5 around Lahore, including Kala Shah Kaku, Muridke, Kamuki, Bhaipheru, Pattoki, and Okara. The study was based on multi-methods approach involving hazard identification through survey and checklist as well as a questionnaire for health status assessment and measurements of health parameters including peak expiratory flow rate (PEFR) and audiometric screening of 300 subjects. The study revealed non-congenial working conditions at the sites. Noise, vibrations, dust, asphalt fumes, poor work postures, and injuries were found to be major health hazards. PEFR of most of the workers was found to be significantly lower than the reference value. Average PEFR±SEM values were 187±5.1 l/min, 178±4.3 l/min, and 266±5.3 l/min in ground preparation workers, asphalt workers, and heavy vehicle drivers, respectively. The highest rate (29%) of hearing loss was recorded among heavy vehicle drivers. Musculoskeletal problems were found to be more common among ground preparation workers. Data revealed unsatisfactory health status of most of the workers. Direct relationship between health outcomes and the type of construction activities were observed. The current study focuses on the importance of including occupational health and safety plan in the execution phase of every developmental project that involves construction activities.

  9. Phase angle and World Health Organization criteria for the assessment of nutritional status in children with osteogenesis imperfecta

    PubMed Central

    Pileggi, Vicky Nogueira; Scalize, Antonio Rodolpho Hakime; Camelo, José Simon

    2016-01-01

    Abstract Objective: To compare the phase angle of patients with osteogenesis imperfecta treated at a tertiary university hospital with patients in a control group of healthy children, and to assess the nutritional status of these patients through the body mass index proposed by the World Health Organization. Methods: Cross-sectional study carried out in a university hospital that included seven patients with osteogenesis imperfecta and a control group of 17 healthy children of the same gender and age. Weight and height were measured and bioelectrical impedance was performed. Subsequently, the phase angle was calculated based on resistance and reactance values. Results: The phase angle of the group of children with osteogenesis imperfecta was significantly lower than that of the control group (p<0.05). The body mass index criterion for age of the World Health Organization showed no difference between groups. Conclusions: Children with osteogenesis imperfecta have a nutritional risk detected by the phase angle, which is a useful tool for nutritional screening. The calculation result could help in the diet therapy of patients with osteogenesis imperfecta. PMID:27102998

  10. Is the step-wise tiered approach for ERA of pharmaceuticals useful for the assessment of cancer therapeutic drugs present in marine environment?

    PubMed

    Aguirre-Martínez, G V; Okello, C; Salamanca, M J; Garrido, C; Del Valls, T A; Martín-Díaz, M L

    2016-01-01

    Methotrexate (MTX) and tamoxifen (TMX) cancer therapeutic drugs have been detected within the aquatic environment. Nevertheless, MTX and TMX research is essentially bio-medically orientated, with few studies addressing the question of its toxicity in fresh water organisms, and none to its' effect in the marine environment. To the authors' knowledge, Environmental Risk Assessments (ERA) for pharmaceuticals has mainly been designed for freshwater and terrestrial environments (European Medicines Agency-EMEA guideline, 2006). Therefore, the purpose of this research was (1) to assess effect of MTX and TMX in marine organism using the EMEA guideline, (2) to develop an ERA methodology for marine environment, and (3) to evaluate the suitability of including a biomarker approach in Phase III. To reach these aims, a risk assessment of MTX and TMX was performed following EMEA guideline, including a 2-tier approach during Phase III, applying lysosomal membrane stability (LMS) as a screening biomarker in tier-1 and a battery of biochemical biomarkers in tier-2. Results from Phase II indicated that MTX was not toxic for bacteria, microalgae and sea urchin at the concentrations tested, thus no further assessment was required, while TMX indicated a possible risk. Therefore, Phase III was performed for only TMX. Ruditapes philippinarum were exposed during 14 days to TMX (0.1, 1, 10, 50 μg L(-1)). At the end of the experiment, clams exposed to environmental concentration indicated significant changes in LMS compared to the control (p<0.01); thus a second tier was applied. A significant induction of biomarkers (activity of Ethoxyresorufin O-deethylase [EROD], glutathione S-transferase [GST], glutathione peroxidase [GPX], and lipid peroxidation [LPO] levels) was observed in digestive gland tissues of clams compared with control (p<0.01). Finally, this study indicated that MTX was not toxic at an environmental concentration, whilst TMX was potentially toxic for marine biota. This study has shown the necessity to create specific guidelines in order to evaluate effects of pharmaceuticals in marine environment which includes sensitive endpoints. The inadequacy of current EMEA guideline to predict chemotherapy agents toxicity in Phase II was displayed whilst the usefulness of other tests were demonstrated. The 2-tier approach, applied in Phase III, appears to be suitable for an ERA of cancer therapeutic drugs in the marine environment. Copyright © 2015 Elsevier Inc. All rights reserved.

  11. Assessing Hopelessness in Terminally Ill Cancer Patients: Development of the Hopelessness Assessment in Illness Questionnaire

    PubMed Central

    Rosenfeld, Barry; Pessin, Hayley; Lewis, Charles; Abbey, Jennifer; Olden, Megan; Sachs, Emily; Amakawa, Lia; Kolva, Elissa; Brescia, Robert; Breitbart, William

    2013-01-01

    Hopelessness has become an increasingly important construct in palliative care research, yet concerns exist regarding the utility of existing measures when applied to patients with a terminal illness. This article describes a series of studies focused on the exploration, development, and analysis of a measure of hopelessness specifically intended for use with terminally ill cancer patients. The 1st stage of measure development involved interviews with 13 palliative care experts and 30 terminally ill patients. Qualitative analysis of the patient interviews culminated in the development of a set of potential questionnaire items. In the 2nd study phase, we evaluated these preliminary items with a sample of 314 participants, using item response theory and classical test theory to identify optimal items and response format. These analyses generated an 8-item measure that we tested in a final study phase, using a 3rd sample (n = 228) to assess reliability and concurrent validity. These analyses demonstrated strong support for the Hopelessness Assessment in Illness Questionnaire providing greater explanatory power than existing measures of hopelessness and found little evidence that this assessment was confounded by illness-related variables (e.g., prognosis). In summary, these 3 studies suggest that this brief measure of hopelessness is particularly useful for palliative care settings. Further research is needed to assess the applicability of the measure to other populations and contexts. PMID:21443366

  12. Prevention of venous thromboembolism in long term care: results of a multicenter educational intervention using clinical practice guidelines: part 2 of 2 (an AMDA Foundation project).

    PubMed

    Dharmarajan, T S; Nanda, Aman; Agarwal, Bikash; Agnihotri, Parag; Doxsie, G L; Gokula, Murthy; Javaheri, Ashkan; Kanagala, M; Lebelt, Anna S; Madireddy, Prasuna; Mahapatra, Sourya; Murakonda, P; Muthavarapu, S Ram Rao; Patel, Mennakshi; Patterson, Christopher; Soch, Kathleen; Troncales, Anna; Yaokim, Kamal; Kroft, Robin; Norkus, Edward P

    2012-03-01

    Implementation of prophylaxis for venous thomboembolism (VTE) through risk assessment based on clinical practice guidelines (CPGs) is variably adopted in long term care facilities (LTCF). Current guidelines recommend venous thromboembolism prophylaxis (VTE-P) following risk assessment, individualized to patient status. In LTCF, differing comorbidity, life-expectancy, ethical, and quality-of-life issues may warrant a unique approach. This article examines VTE-P practices in LTCF before and after educational intervention to bring practice patterns consistent with CPGs. Phase 1 (preceding article in this issue) identified current practice to assess risk and implement VTE-P (17 geographically diverse LTCFs, 3260 total beds). Phase 2 (educational intervention using CPGs) and Phase 3 (outcomes) reexamined VTE-P at the same 17 centers. The frequency of indications for VTE-P and contraindications to anticoagulation were similar during Phases 1 and 3 (all P > .05). In Phase 3, use of aspirin alone decreased more than 50% (P < .0005), whereas use of compression devices increased (P < .0005). Regression models predicted no relationship between any indication or contraindication and VTE-P in Phase 1 (all P > .05) but identified significant relationships between indication and contraindications and VTE-P in Phase 3 (P = .022 to P < .0005), suggesting adequate understanding of current CPGs following education as the basis for improved VTE-P. The study confirms the presence of significant comorbidity in LTC residents, many with indications for VTE-P, some with contraindications for anticoagulation. Following educational intervention, more residents received VTE-P, influenced by risk-benefit ratio favoring treatment. These findings suggest that even a modest educational intervention significantly improves provider knowledge pertinent to risk assessment consistent with CPG and more appropriate VTE-P. Copyright © 2012 American Medical Directors Association, Inc. Published by Elsevier Inc. All rights reserved.

  13. Nutrition Education and Training Needs Assessment Project for Federal Fiscal Year 1993: Texas Nutrition Education & Training. Final Annual Report.

    ERIC Educational Resources Information Center

    Martin, Ruth E.; Hoover, Linda C.

    This report, organized into two parts, presents the needs assessment study conducted for the state of Texas. The first section describes Phase One of the study which identified the goals and criteria pertaining to each of the NET target populations, namely: children, parents, educators, food service personnel, and administrators. The second part…

  14. Department of Defense Dependents Schools Comprehensive Social Studies Program Evaluation, Spring, 1980. Summary Report.

    ERIC Educational Resources Information Center

    National Evaluation Systems, Inc., Amherst, MA.

    The methodology and results of an assessment designed to determine the status of educational quality in grades 4, 8, and 11 social studies programs of the Department of Defense Dependents Schools (DODDS) is summarized. The assessment was part of the DODDS five-year curriculum development cycle comprised of the following phases: (1) development of…

  15. Assessment of Fear in Children with an Autism Spectrum Disorder

    ERIC Educational Resources Information Center

    Turner, Laura B.; Romanczyk, Raymond G.

    2012-01-01

    Although intense fears have been reported in up to 64% of children with an autism spectrum disorder (ASD), little is known about the phenomenology of fear in this population. This study assessed the relationship between fear and core symptoms of autism in children with an ASD. In Phase I of this study, parents of 41 children with an ASD completed…

  16. An Assessment of Feedback Procedures and Information Provided to Instructors within Computer Managed Learning Environments--Implications for Instruction and Software Redesign.

    ERIC Educational Resources Information Center

    Kotesky, Arturo A.

    Feedback procedures and information provided to instructors within computer managed learning environments were assessed to determine current usefulness and meaningfulness to users, and to present the design of a different instructor feedback instrument. Kaufman's system model was applied to accomplish the needs assessment phase of the study; and…

  17. Developing an ICT-Literacy Task-Based Assessment Instrument: The Findings on the Final Testing Phase

    ERIC Educational Resources Information Center

    Mat-jizat, Jessnor Elmy

    2013-01-01

    This paper reports the findings of a study which seeks to identify the information and communications technology (ICT) literacy levels of trainee teachers, by investigating their ICT proficiency using a task-bask assessment instrument. The Delphi technique was used as a primary validation method for the new assessment tool and the ICT literacy…

  18. Analysis of nuclear waste disposal in space, phase 3. Volume 1: Executive summary of technical report

    NASA Technical Reports Server (NTRS)

    Rice, E. E.; Miller, N. E.; Yates, K. R.; Martin, W. E.; Friedlander, A. L.

    1980-01-01

    The objectives, approach, assumptions, and limitations of a study of nuclear waste disposal in space are discussed with emphasis on the following: (1) payload characterization; (2) safety assessment; (3) health effects assessment; (4) long-term risk assessment; and (5) program planning support to NASA and DOE. Conclusions are presented for each task.

  19. OECD/NEA expert group on uncertainty analysis for criticality safety assessment: Results of benchmark on sensitivity calculation (phase III)

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

    Ivanova, T.; Laville, C.; Dyrda, J.

    2012-07-01

    The sensitivities of the k{sub eff} eigenvalue to neutron cross sections have become commonly used in similarity studies and as part of the validation algorithm for criticality safety assessments. To test calculations of the sensitivity coefficients, a benchmark study (Phase III) has been established by the OECD-NEA/WPNCS/EG UACSA (Expert Group on Uncertainty Analysis for Criticality Safety Assessment). This paper presents some sensitivity results generated by the benchmark participants using various computational tools based upon different computational methods: SCALE/TSUNAMI-3D and -1D, MONK, APOLLO2-MORET 5, DRAGON-SUSD3D and MMKKENO. The study demonstrates the performance of the tools. It also illustrates how model simplificationsmore » impact the sensitivity results and demonstrates the importance of 'implicit' (self-shielding) sensitivities. This work has been a useful step towards verification of the existing and developed sensitivity analysis methods. (authors)« less

  20. Assessment of Institutional Capacities of Flood Management Institution in Pakistan

    NASA Astrophysics Data System (ADS)

    Khan, Noor M.

    2009-03-01

    Pakistan is frequently devastated by floods. The flood impacts can be reduced if the flood management institutional capacities are improved. This paper reviews and assesses the capacities of flood management institution in Pakistan. Citing a number of case studies about the flood management practices in Pakistan, the study estimates the weaknesses and strengths of the institution with respect to various phases of flood management, namely, mitigation, preparedness, response, and rehabilitation and also with respect to various characteristics of institutions, namely, deliberation, coordination, implementation, and evaluation, using an improved capacity assessment framework. It has been found that the performance of the mitigation and rehabilitation phases is not satisfactory and that of preparedness and response is satisfactory. It is concluded that the functions of deliberation need to be improved while the other three characteristics of institution namely, coordination, implementation, and evaluation are performing well. The study will help the policy makers to concentrate on the identified weak capacities.

  1. Selectivity assessment of DB-200 and DB-VRX open-tubular capillary columns.

    PubMed

    Kiridena, W; Koziola, W W; Poole, C F

    2001-10-12

    The solvation parameter model is used to study the influence of composition and temperature on the selectivity of two poly(siloxane) stationary phases used for open-tubular capillary column gas chromatography. The poly(methyltrifluoropropyldimethylsiloxane) stationary phase, DB-200, has low cohesion, intermediate dipolarity/polarizability, low hydrogen-bond basicity, no hydrogen-bond acidity, and repulsive electron lone pair interactions. The DB-VRX stationary phase has low cohesion, low dipolarity/polarizability, low hydrogen-bond basicity and no hydrogen-bond acidity and no capacity for electron lone pair interactions. The selectivity of the two stationary phases is complementary to those in a database of 11 stationary phase chemistries determined under the same experimental conditions.

  2. Psychometric Properties of a Short Measure for Psychosocial Factors and Associations With Phase of Physical Activity Change Among Finnish Working-Aged Men

    PubMed Central

    Kaasalainen, Karoliina; Kasila, Kirsti; Komulainen, Jyrki; Malvela, Miia; Poskiparta, Marita

    2015-01-01

    Insufficient physical activity (PA) and poor physical fitness are risks for several noncommunicable diseases among working-aged men. PA programs have been launched to increase activity levels in the population but working-aged men have been underrepresented in these programs. The aim of the present cross-sectional study was to evaluate validity of a short scale for psychosocial factors among Finnish working-aged men who participated in a PA campaign. The study examined also the associations between psychosocial factors and phase of PA change across fitness groups. Physical fitness was assessed with a body fitness index constructed on the basis of a handgrip test, the Polar OwnIndex Test, and body composition analysis (InBody 720). The men were classified into low (n = 162), moderate (n = 358), and high (n = 320) body fitness index groups. Psychosocial factors and self-reported phase of PA change were assessed with a questionnaire. Psychometric properties of the scale were assessed with confirmatory factor analysis and differences between phases of PA change were examined with one-way analysis of variance. The evaluated scale included factors for self-efficacy, goal setting, skills, and social support. Good physical fitness was related to better perceived self-efficacy and ability to manage one’s PA environment. Goal setting was critical for PA change at all fitness levels. Better understanding of the interactions between psychosocial factors and PA change could help in targeting PA programs to low-fit men. Further study should examine the validity of the improved psychosocial measure. PMID:26614443

  3. Comprehensive classification test of scapular dyskinesis: A reliability study.

    PubMed

    Huang, Tsun-Shun; Huang, Han-Yi; Wang, Tyng-Guey; Tsai, Yung-Shen; Lin, Jiu-Jenq

    2015-06-01

    Assessment of scapular dyskinesis (SD) is of clinical interest, as SD is believed to be related to shoulder pathology. However, no clinical assessment with sufficient reliability to identify SD and provide treatment strategies is available. The purpose of this study was to investigate the reliability of the comprehensive SD classification method. Cross-sectional reliability study. Sixty subjects with unilateral shoulder pain were evaluated by two independent physiotherapists with a visual-based palpation method. SD was classified as single abnormal scapular pattern [inferior angle (pattern I), medial border (pattern II), superior border of scapula prominence or abnormal scapulohumeral rhythm (pattern III)], a mixture of the above abnormal scapular patterns, or normal pattern (pattern IV). The assessment of SD was evaluated as subjects performed bilateral arm raising/lowering movements with a weighted load in the scapular plane. Percentage of agreement and kappa coefficients were calculated to determine reliability. Agreement between the 2 independent physiotherapists was 83% (50/60, 6 subjects as pattern III and 44 subjects as pattern IV) in the raising phase and 68% (41/60, 5 subjects as pattern I, 12 subjects as pattern II, 12 subjects as pattern IV, 12 subjects as mixed patterns I and II) in the lowering phase. The kappa coefficients were 0.49-0.64. We concluded that the visual-based palpation classification method for SD had moderate to substantial inter-rater reliability. The appearance of different types of SD was more pronounced in the lowering phase than in the raising phase of arm movements. Copyright © 2014 Elsevier Ltd. All rights reserved.

  4. Quality of life assessment in cosmetics: specificity and interest of the international BeautyQol instrument.

    PubMed

    Beresniak, Ariel; Auray, Jean-Paul; Duru, Gérard; Aractingi, Selim; Krueger, Gerald G; Talarico, Sergio; Tsutani, Kiichiro; Dupont, Danielle; de Linares, Yolaine

    2015-09-01

    The wide use of cosmetics and their perceived benefits upon well-being imply objective descriptions of their effects upon the different dimensions contributing to the quality of life (QoL). Such a goal pleas for using relevant and validated scientific instruments with robust measurement methods. This paper discusses the interest of the new validated questionnaire BeautyQoL specifically designed to assess the effect of cosmetic products on physical appearance and QoL. After conducting a review of skin appearance and QoL, three phases of the international codevelopment have been carried out in the following sequence: semi-directed interviews (Phase 1), acceptability study (Phase 2), and validation study (Phase 3). Data collection and validation process have been carried out in 16 languages. This review confirms that QoL instruments developed in dermatology are not suitable to assess cosmetic products, mainly because of their lack of sensitivity. General acceptability of BeautyQol was very good. Forty-two questions have been structured in five dimensions that explained 76.7% of the total variance: Social Life, Self-confidence, Mood, Vitality, and Attractiveness. Cronbach's alpha coefficients are between 0.932 and 0.978, confirming the good internal consistency of the results. The BeautyQol questionnaire is the first international instrument specific to cosmetic products and physical appearance that has been validated in 16 languages and could be used in a number of clinical trials and descriptive studies to demonstrate the added value of these products on the QoL. © 2015 Wiley Periodicals, Inc.

  5. Effect of urgent treatment of transient ischaemic attack and minor stroke on early recurrent stroke (EXPRESS study): a prospective population-based sequential comparison.

    PubMed

    Rothwell, Peter M; Giles, Matthew F; Chandratheva, Arvind; Marquardt, Lars; Geraghty, Olivia; Redgrave, Jessica N E; Lovelock, Caroline E; Binney, Lucy E; Bull, Linda M; Cuthbertson, Fiona C; Welch, Sarah J V; Bosch, Shelley; Alexander, Faye C; Carasco-Alexander, Faye; Silver, Louise E; Gutnikov, Sergei A; Mehta, Ziyah

    2007-10-20

    The risk of recurrent stroke is up to 10% in the week after a transient ischaemic attack (TIA) or minor stroke. Modelling studies suggest that urgent use of existing preventive treatments could reduce the risk by 80-90%, but in the absence of evidence many health-care systems make little provision. Our aim was to determine the effect of more rapid treatment after TIA and minor stroke in patients who are not admitted direct to hospital. We did a prospective before (phase 1: April 1, 2002, to Sept 30, 2004) versus after (phase 2: Oct 1, 2004, to March 31, 2007) study of the effect on process of care and outcome of more urgent assessment and immediate treatment in clinic, rather than subsequent initiation in primary care, in all patients with TIA or minor stroke not admitted direct to hospital. The study was nested within a rigorous population-based incidence study of all TIA and stroke (Oxford Vascular Study; OXVASC), such that case ascertainment, investigation, and follow-up were complete and identical in both periods. The primary outcome was the risk of stroke within 90 days of first seeking medical attention, with independent blinded (to study period) audit of all events. Of the 1278 patients in OXVASC who presented with TIA or stroke (634 in phase 1 and 644 in phase 2), 607 were referred or presented direct to hospital, 620 were referred for outpatient assessment, and 51 were not referred to secondary care. 95% (n=591) of all outpatient referrals were to the study clinic. Baseline characteristics and delays in seeking medical attention were similar in both periods, but median delay to assessment in the study clinic fell from 3 (IQR 2-5) days in phase 1 to less than 1 (0-3) day in phase 2 (p<0.0001), and median delay to first prescription of treatment fell from 20 (8-53) days to 1 (0-3) day (p<0.0001). The 90-day risk of recurrent stroke in the patients referred to the study clinic was 10.3% (32/310 patients) in phase 1 and 2.1% (6/281 patients) in phase 2 (adjusted hazard ratio 0.20, 95% CI 0.08-0.49; p=0.0001); there was no significant change in risk in patients treated elsewhere. The reduction in risk was independent of age and sex, and early treatment did not increase the risk of intracerebral haemorrhage or other bleeding. Early initiation of existing treatments after TIA or minor stroke was associated with an 80% reduction in the risk of early recurrent stroke. Further follow-up is required to determine long-term outcome, but these results have immediate implications for service provision and public education about TIA and minor stroke.

  6. Light Modulates Ocular Complications in an Albino Rat Model of Type 1 Diabetes Mellitus.

    PubMed

    Andrawus, Elias; Veildbaum, Gizi; Zemel, Esther; Leibu, Rina; Perlman, Ido; Shehadeh, Naim

    2017-07-01

    The purpose of the study was to assess potential interactions of light exposure and hyperglycemia upon ocular complications in diabetic rats. Streptozotocin-induced (STZ-induced) diabetic rats ( N = 39) and non-diabetic rats ( N = 9) were distributed into eight groups according to the irradiance and color of the light phase during the 12/12-hour light/dark regime. Follow-up lasted 90 days and included assessment of cataract development and electroretinogram (ERG) recordings. Stress to the retina was also assessed by glial fibrillary acidic protein immunocytochemistry. Cataract development was fast in diabetic rats that were exposed to unattenuated white light or to bright colored lights during the light phase. Diabetic rats that were kept under attenuated brown or yellow light during the light phase exhibited slower rate of cataract development. Electroretinogram responses indicated very severe retinal damage in diabetic rats kept under bright colored lights in the blue-yellow range or bright white light during the light phase. Electroretinogram damage was milder in rats kept under bright red light or attenuated yellow or brown light during the light phase. Glial fibrillary acidic protein expression in retinal Müller cells was consistent with ERG assessment of retinal damage. Attenuating white light and filtering out short wavelengths have a protective effect on the eyes of diabetic rats as evident by slower rate of cataract formation and a smaller degree of retinal damage. Our findings suggest that special glasses attenuating light exposure and filtering out short wavelengths (400-530 nm) may be beneficial for diabetic patients.

  7. Development and initial validation of the Parental PELICAN Questionnaire (PaPEQu)--an instrument to assess parental experiences and needs during their child's end-of-life care.

    PubMed

    Zimmermann, Karin; Cignacco, Eva; Eskola, Katri; Engberg, Sandra; Ramelet, Anne-Sylvie; Von der Weid, Nicolas; Bergstraesser, Eva

    2015-12-01

    To develop and test the Parental PELICAN Questionnaire, an instrument to retrospectively assess parental experiences and needs during their child's end-of-life care. To offer appropriate care for dying children, healthcare professionals need to understand the illness experience from the family perspective. A questionnaire specific to the end-of-life experiences and needs of parents losing a child is needed to evaluate the perceived quality of paediatric end-of-life care. This is an instrument development study applying mixed methods based on recommendations for questionnaire design and validation. The Parental PELICAN Questionnaire was developed in four phases between August 2012-March 2014: phase 1: item generation; phase 2: validity testing; phase 3: translation; phase 4: pilot testing. Psychometric properties were assessed after applying the Parental PELICAN Questionnaire in a sample of 224 bereaved parents in April 2014. Validity testing covered the evidence based on tests of content, internal structure and relations to other variables. The Parental PELICAN Questionnaire consists of approximately 90 items in four slightly different versions accounting for particularities of the four diagnostic groups. The questionnaire's items were structured according to six quality domains described in the literature. Evidence of initial validity and reliability could be demonstrated with the involvement of healthcare professionals and bereaved parents. The Parental PELICAN Questionnaire holds promise as a measure to assess parental experiences and needs and is applicable to a broad range of paediatric specialties and settings. Future validation is needed to evaluate its suitability in different cultures. © 2015 John Wiley & Sons Ltd.

  8. Phase angle assessment by bioelectrical impedance analysis and its predictive value for malnutrition risk in hospitalized geriatric patients.

    PubMed

    Varan, Hacer Dogan; Bolayir, Basak; Kara, Ozgur; Arik, Gunes; Kizilarslanoglu, Muhammet Cemal; Kilic, Mustafa Kemal; Sumer, Fatih; Kuyumcu, Mehmet Emin; Yesil, Yusuf; Yavuz, Burcu Balam; Halil, Meltem; Cankurtaran, Mustafa

    2016-12-01

    Phase angle (PhA) value determined by bioelectrical impedance analysis (BIA) is an indicator of cell membrane damage and body cell mass. Recent studies have shown that low PhA value is associated with increased nutritional risk in various group of patients. However, there have been only a few studies performed globally assessing the relationship between nutritional risk and PhA in hospitalized geriatric patients. The aim of the study is to evaluate the predictive value of the PhA for malnutrition risk in hospitalized geriatric patients. One hundred and twenty-two hospitalized geriatric patients were included in this cross-sectional study. Comprehensive geriatric assessment tests and BIA measurements were performed within the first 48 h after admission. Nutritional risk state of the patients was determined with NRS-2002. Phase angle values of the patients with malnutrition risk were compared with the patients that did not have the same risk. The independent variables for predicting malnutrition risk were determined. SPSS version 15 was utilized for the statistical analyzes. The patients with malnutrition risk had significantly lower phase angle values than the patients without malnutrition risk (p = 0.003). ROC curve analysis suggested that the optimum PhA cut-off point for malnutrition risk was 4.7° with 79.6 % sensitivity, 64.6 % specificity, 73.9 % positive predictive value, and 73.9 % negative predictive value. BMI, prealbumin, PhA, and Mini Mental State Examination Test scores were the independent variables for predicting malnutrition risk. PhA can be a useful, independent indicator for predicting malnutrition risk in hospitalized geriatric patients.

  9. Maximal force and tremor changes across the menstrual cycle.

    PubMed

    Tenan, Matthew S; Hackney, Anthony C; Griffin, Lisa

    2016-01-01

    Sex hormones have profound effects on the nervous system in vitro and in vivo. The present study examines the effect of the menstrual cycle on maximal isometric force (MVC) and tremor during an endurance task. Nine eumenorrheic females participated in five study visits across their menstrual cycle. In each menstrual phase, an MVC and an endurance task to failure were performed. Tremor across the endurance task was quantified as the coefficient of variation in force and was assessed in absolute time and relative percent time to task failure. MVC decreases 23% from ovulation to the mid luteal phase of the menstrual cycle. In absolute time, the mid luteal phase has the highest initial tremor, though the early follicular phase has substantially higher tremor than other phases after 150 s of task performance. In relative time, the mid luteal phase has the highest level of tremor throughout the endurance task. Both MVC and tremor during an endurance task are modified by the menstrual cycle. Performance of tasks and sports which require high force and steadiness to exhaustion may be decreased in the mid luteal phase compared to other menstrual phases.

  10. The comprehensive community-based traffic safety program : phase II, program assessment for District 2 and District 7, final report.

    DOT National Transportation Integrated Search

    1987-01-01

    The program assessment phase was designed to identify community resources and address the recommendation, made in Phase I, that initial countermeasures should target the program areas of occupant protection, alcohol, selective enforcement, and pedest...

  11. A systematic review of treatment intensity in speech disorders.

    PubMed

    Kaipa, Ramesh; Peterson, Abigail Marie

    2016-12-01

    Treatment intensity (sometimes referred to as "practice amount") has been well-investigated in learning non-speech tasks, but its role in treating speech disorders has not been largely analysed. This study reviewed the literature regarding treatment intensity in speech disorders. A systematic search was conducted in four databases using appropriate search terms. Seven articles from a total of 580 met the inclusion criteria. The speech disorders investigated included speech sound disorders, dysarthria, acquired apraxia of speech and childhood apraxia of speech. All seven studies were evaluated for their methodological quality, research phase and evidence level. Evidence level of reviewed studies ranged from moderate to strong. With regard to the research phase, only one study was considered to be phase III research, which corresponds to the controlled trial phase. The remaining studies were considered to be phase II research, which corresponds to the phase where magnitude of therapeutic effect is assessed. Results suggested that higher treatment intensity was favourable over lower treatment intensity of specific treatment technique(s) for treating childhood apraxia of speech and speech sound (phonological) disorders. Future research should incorporate randomised-controlled designs to establish optimal treatment intensity that is specific to each of the speech disorders.

  12. Catheter associated urinary tract infection (CA-UTI) incidence in an Internal Medicine Ward of a Northern Italian Hospital.

    PubMed

    Izzo, Ilaria; Lania, Donatella; Bella, Daniele; Formaini Marioni, Cesare; Coccaglio, Romana; Colombini, Paolo

    2015-09-01

    Catheter-associated urinary tract infections (CA-UTI) are estimated to be the most frequent nosocomial infections (40%). A catheter is introduced to 10-25% of inpatients, and is often left on site for a long period of time. We carried out a prospective study on inpatients of our Internal Medicine ward to assess the incidence of CA-UTI under the implementation of corrective action. All inpatients who underwent introduction of a urinary catheter upon or after admission to our ward were included in the study. Patients with bacteriuria or positive urine culture before catheterization, others with less than 24 hours catheterism, or bearing a catheter on admission were all excluded from the study. CA-UTI diagnosis was assessed on the basis of CDC 2009 guidelines. The investigation was held between June 2010 and March 2013 in five steps or phases. In the first phase open circuit drainage catheterism was used, in the second phase close circuit drainage catheterism was introduced, while in the third phase disposable lubrification was added to closed circuit drainage catheterism. In the next step (phase 4) we introduced number of days of catheterism control and nurse training; in the last phase (5) emptying urine collection bags on a container was added. In phase 1 we estimated six UTIs out of 18 patients (incidence 33%), in phase 2 we had four infections out of 10 patients (40%). Given the results, we had to reflect on the quality of the procedures of catheter positioning and management . Where feasible, we improved technical practices and during follow-up there was evidence of CA-UTI in 10 patients over 25 (phase 3, 40%), and eight infections over 25 (phase 4, 32%). Once all these steps had been implemented, in phase 5 we determined a sharp reduction in CA-UTI (2 patients over 27, or 7.5%, p=0.025). This improvement was particularly evident in the rate of infection per days of catheter, which was reduced from 43.4/1000 to 13.6/1000. Although the statistical power of the present study has its limitations, we attained a significant reduction in catheter-associated UTIs through the implementation of close circuit catheterism and improvements in care practices.

  13. Developing a pressure ulcer risk factor minimum data set and risk assessment framework.

    PubMed

    Coleman, Susanne; Nelson, E Andrea; Keen, Justin; Wilson, Lyn; McGinnis, Elizabeth; Dealey, Carol; Stubbs, Nikki; Muir, Delia; Farrin, Amanda; Dowding, Dawn; Schols, Jos M G A; Cuddigan, Janet; Berlowitz, Dan; Jude, Edward; Vowden, Peter; Bader, Dan L; Gefen, Amit; Oomens, Cees W J; Schoonhoven, Lisette; Nixon, Jane

    2014-10-01

    To agree a draft pressure ulcer risk factor Minimum Data Set to underpin the development of a new evidenced-based Risk Assessment Framework. A recent systematic review identified the need for a pressure ulcer risk factor Minimum Data Set and development and validation of an evidenced-based pressure ulcer Risk Assessment Framework. This was undertaken through the Pressure UlceR Programme Of reSEarch (RP-PG-0407-10056), funded by the National Institute for Health Research and incorporates five phases. This article reports phase two, a consensus study. Consensus study. A modified nominal group technique based on the Research and Development/University of California at Los Angeles appropriateness method. This incorporated an expert group, review of the evidence and the views of a Patient and Public Involvement service user group. Data were collected December 2010-December 2011. The risk factors and assessment items of the Minimum Data Set (including immobility, pressure ulcer and skin status, perfusion, diabetes, skin moisture, sensory perception and nutrition) were agreed. In addition, a draft Risk Assessment Framework incorporating all Minimum Data Set items was developed, comprising a two stage assessment process (screening and detailed full assessment) and decision pathways. The draft Risk Assessment Framework will undergo further design and pre-testing with clinical nurses to assess and improve its usability. It will then be evaluated in clinical practice to assess its validity and reliability. The Minimum Data Set could be used in future for large scale risk factor studies informing refinement of the Risk Assessment Framework. © 2014 The Authors. Journal of Advanced Nursing Published by John Wiley & Sons Ltd.

  14. Familias Unidas for high risk adolescents: Study design of a cultural adaptation and randomized controlled trial of a U.S. drug and sexual risk behavior intervention in Ecuador.

    PubMed

    Jacobs, Petra; Estrada, Yannine A; Tapia, Maria I; Quevedo Terán, Ana M; Condo Tamayo, Cecilia; Albán García, Mónica; Valenzuela Triviño, Gilda M; Pantin, Hilda; Velazquez, Maria R; Horigian, Viviana E; Alonso, Elizabeth; Prado, Guillermo

    2016-03-01

    Developing, testing and implementing evidence-based prevention interventions are important in decreasing substance use and sexual risk behavior among adolescents. This process requires research expertise, infrastructure, resources and decades of research testing, which might not always be feasible for low resource countries. Adapting and testing interventions proven to be efficacious in similar cultures might circumvent the time and costs of implementing evidence-based interventions in new settings. This paper describes the two-phase study, including training and development of the research infrastructure in the Ecuadorian university necessary to implement a randomized controlled trial. Familias Unidas is a multilevel parent-centered intervention designed in the U.S. to prevent drug use and sexual risk behaviors in Hispanic adolescents. The current study consisted of Phase 1 feasibility study (n=38) which adapted the intervention and study procedures within a single-site school setting in an area with a high prevalence of drug use and unprotected sexual behavior among adolescents in Ecuador, and Phase 2 randomized controlled trial of the adapted intervention in two public high schools with a target population of families with adolescents from 12 to 14 years old. The trial is currently in Phase 2. Study recruitment was completed with 239 parent-youth dyads enrolling. The intervention phase and the first follow-up assessment have been completed. The second and third follow-up assessments will be completed in 2016. This project has the potential of benefitting a large population of families in areas of Ecuador that are disproportionally affected by drug trafficking and its consequences. MSP-DIS-2015-0055-0, Ministry of Public Health (MSP), Quito, Ecuador. Copyright © 2016 Elsevier Inc. All rights reserved.

  15. Response of detoxification system genes on Chironomus riparius aquatic larvae after antibacterial agent triclosan exposures.

    PubMed

    Martínez-Paz, Pedro

    2018-05-15

    Triclosan (TCS) is an antimicrobial agent used in a range of personal care and consumer products and is commonly detected in aquatic ecosystems. In the present study, the effects of TCS at the molecular level on the detoxification system of Chironomus riparius aquatic larvae, a test organism widely used for the assessment of aquatic toxicology, were evaluated. The obtained results show that this xenobiotic was able to induce significant changes in transcripts from different cytochrome P450s and glutathione s-transferases genes, involved in phase I and phase II of detoxification system, respectively. In contrast, TCS did not affect the glutathione S-transferase enzyme activity nor the expression pattern of multidrug resistance-associated protein 1, which belongs to phase III of detoxification system. These results provide information about the effects of TCS on the detoxification mechanism of C. riparius and offers different biomarker genes that could be useful in ecotoxicological studies, risk assessment and bioremediation. Copyright © 2017 Elsevier B.V. All rights reserved.

  16. An Assessment of the Effects of Hydrotherapy During the Active Phase of Labor on the Labor Process and Parenting Behavior.

    PubMed

    Tuncay, Semra; Kaplan, Sena; Moraloglu Tekin, Ozlem

    2017-12-01

    This study was conducted to assess the effect on labor process and parenting behavior of hydrotherapy applied during the active phase of labor. This quasi-experimental study was conducted by using an equivalent comparison group ( n = 40). The participants in the experimental group whose cervical dilation was 5 cm were taken to the hydrotherapy tub. This application continued until cervical dilation reached 10 cm. The Participants Questionnaire, The Birth Follow-up Questionnaire, The Postpartum ]collection tools. The duration of the active phase and second stage of labor was extremely short in the experimental group in comparison with the equivalent comparison group ( p = .001). The Visual Analogue Scale (VAS) scores of the experimental group were lower than those of the equivalent comparison group when cervical dilation was 6 cm and 10 cm ( p = .001). The experimental group also displayed more positive parenting behavior and positive labor feeling ( p = .001).

  17. Adherence and Acceptability of a Multidrug Vaginal Ring for HIV Prevention in a Phase I Study in the United States

    PubMed Central

    van der Straten, Ariane; Panther, Lori; Laborde, Nicole; Hoesley, Craig; Cheng, Helen; Husnik, Marla; Horn, Stephanie; Nel, Annalene; Soto-Torres, Lydia; Chen, Beatrice A.

    2016-01-01

    We evaluated the adherence and acceptability of a vaginal ring containing dapivirine, maraviroc, or both drugs for 28 days during a Phase I placebo-controlled trial in 48 HIV-negative sexually abstinent U.S. women aged 18 to 40. Adherence was assessed weekly by clinical interview and computer-assisted self-interviewing; acceptability assessment occurred at the last product-use visit. Study retention was 98% (47/48); 94% (45/48) reported being fully adherent with ring use during the 28-day period. Two participants experienced the ring partially coming out. Analysis was blinded and behavioral data were combined across study groups. Most women reported being very comfortable having the ring in their vagina; 44% preferred continuous use, whereas 51% had no preference compared to episodic use. Although a range of minor ring concerns were expressed, few were actually experienced. High adherence to and acceptability of this vaginal ring in this Phase I trial contributes to its promise as a sustained mechanism for multidrug vaginal microbicide delivery. PMID:26837628

  18. Adherence and Acceptability of a Multidrug Vaginal Ring for HIV Prevention in a Phase I Study in the United States.

    PubMed

    van der Straten, Ariane; Panther, Lori; Laborde, Nicole; Hoesley, Craig J; Cheng, Helen; Husnik, Marla J; Horn, Stephanie; Nel, Annalene; Soto-Torres, Lydia; Chen, Beatrice A

    2016-11-01

    We evaluated the adherence and acceptability of a vaginal ring containing dapivirine, maraviroc, or both drugs for 28 days during a Phase I placebo-controlled trial in 48 HIV-negative sexually abstinent U.S. women aged 18-40. Adherence was assessed weekly by clinical interview and computer-assisted self-interviewing; acceptability assessment occurred at the last product-use visit. Study retention was 98 % (47/48); 94 % (45/48) reported being fully adherent with ring use during the 28-day period. Two participants experienced the ring partially coming out. Analysis was blinded and behavioral data were combined across study groups. Most women reported being very comfortable having the ring in their vagina; 44 % preferred continuous use, whereas 51 % had no preference compared to episodic use. Although a range of minor ring concerns were expressed, few were actually experienced. High adherence to and acceptability of this vaginal ring in this Phase I trial contributes to its promise as a sustained mechanism for multidrug vaginal microbicide delivery.

  19. Implementing disability evaluation and welfare services based on the framework of the international classification of functioning, disability and health: experiences in Taiwan

    PubMed Central

    2013-01-01

    Background Before 2007, the disability evaluation was based on the medical model in Taiwan. According to the People with Disabilities Rights Protection Act, from 2012 the assessment of a person’s eligibility for disability benefits has to be determined based on the International Classification of Functioning, Disability, and Health (ICF) framework nationwide. The purposes of this study were to: 1) design the evaluation tools for disability eligibility system based on the ICF/ICF-Children and Youth; 2) compare the differences of grades of disability between the old and new evaluation systems; 3) analyse the outcome of the new disability evaluation system. Methods To develop evaluation tools and procedure for disability determination, we formed an implementation taskforce, including 199 professional experts, and conducted a small-scale field trial to examine the feasibility of evaluation tools in Phase I. To refine the evaluation tools and process and to compare the difference of the grades of disability between new and old systems, 7,329 persons with disabilities were randomly recruited in a national population-based study in Phase II. To implement the new system smoothly and understand the impact of the new system, the collaboration mechanism was established and data of 168,052 persons who applied for the disability benefits was extracted from the information system and analysed in Phase III. Results The measures of the 43 categories for body function/structure components, the Functioning Scale of Disability Evaluation System for activities/participation components, and the needs assessment have been developed and used in the field after several revisions. In Phase II, there was 49.7% agreement of disability grades between the old and new systems. In Phase III, 110,667 persons with a disability received their welfare services through the new system. Among them, 77% received basic social welfare support, 89% financial support, 24% allowance for assistive technology, 7% caregiver support, 8% nursing care and rehabilitation services at home, and 47% were issued parking permits for persons with disability. Conclusion This study demonstrated that disability evaluation system based on the ICF could provide a common language between disability assessment, needs assessment and welfare services. However, the proposed assessment protocol and tools require additional testing and validation. PMID:24125482

  20. Thermoresponsive Polymers with Lower Critical Solution Temperature- or Upper Critical Solution Temperature-Type Phase Behaviour Do Not Induce Toxicity to Human Endothelial Cells.

    PubMed

    Ji, Yuejia; Zhu, Mengxiang; Gong, Yu; Tang, Haoyu; Li, Juan; Cao, Yi

    2017-01-01

    Thermoresponsive polymers have gained extensive attention as biomedical materials especially for targeted drug delivery systems. We have recently developed water-soluble polypeptide-based thermoresponsive polymers that exhibit lower critical solution temperature (LCST)- or upper critical solution temperature (UCST)-type phase behaviours. In this study, the toxicity of these polymers to human umbilical vein endothelial cells (HUVECs) was investigated to assess the safety and biocompatibility. Up to 100 μg/ml, thermoresponsive polymers did not induce cytotoxicity to HUVECs, showing as unaltered mitochondrial viability assessed as cell counting kit-8 (CCK-8) assay and membrane integrity assessed as lactate dehydrogenase (LDH) assay. Inflammatory response, assessed as the release of chemokine-soluble monocyte chemotactic protein 1 (sMCP-1) and interleukin-8 (IL-8) as well as cytokine IL-6, was not significantly affected by the polymers. In addition, 1 μM thapsigargin (TG), an endoplasmic reticulum (ER) stress inducer, significantly decreased mitochondrial viability, but did not affect membrane integrity or inflammatory response. The presence of thermoresponsive polymers with LCST-type phase behaviour did not further affect the effects of TG. In conclusion, the thermoresponsive polymers used in this study are not toxic to endothelial cells and therefore could be further considered as safe materials for biomedical applications. © 2016 Nordic Association for the Publication of BCPT (former Nordic Pharmacological Society).

  1. [Validation of the knowledge and attitudes of health professionals in the Living Will Declaration process].

    PubMed

    Contreras-Fernández, Eugenio; Barón-López, Francisco Javier; Méndez-Martínez, Camila; Canca-Sánchez, José Carlos; Cabezón Rodríguez, Isabel; Rivas-Ruiz, Francisco

    2017-04-01

    Evaluate the validity and reliability of the knowledge and attitudes of health professionals questionnaire on the Living Will Declaration (LWD) process. Cross-sectional study structured into 3 phases: (i)pilot questionnaire administered with paper to assess losses and adjustment problems; (ii)assessment of the validity and internal reliability, and (iii)assessment of the pre-filtering questionnaire stability (test-retest). Costa del Sol (Malaga) Health Area. January 2014 to April 2015. Healthcare professionals of the Costa del Sol Primary Care District and the Costa del Sol Health Agency. There were 391 (23.6%) responses, and 100 participated in the stability assessment (83 responses). The questionnaire consisted of 2 parts: (i)Knowledge (5 dimensions and 41 items), and (ii)Attitudes (2 dimensions and 17 items). In the pilot study, none of the items lost over 10%. In the evaluation phase of validity and reliability, the questionnaire was reduced to 41 items (29 of knowledge, and 12 of attitudes). In the stability evaluation phase, all items evaluated met the requirement of a kappa higher than 0.2, or had a percentage of absolute agreement exceeding 75%. The questionnaire will identify the status and areas for improvement in the health care setting, and then will allow an improved culture of LWD process in general population. Copyright © 2016 Elsevier España, S.L.U. All rights reserved.

  2. How to Assess Your Training Needs.

    ERIC Educational Resources Information Center

    Ceramics, Glass, and Mineral Products Industry Training Board, Harrow (England).

    In discussing a method for assessing training needs, this paper deals with various phases of training and points out the importance of outside specialists, the recording of information, and the use of alternative methods. Then five case studies are presented, illustrating each of the industrial groups within the Board's scope: extractives, cement…

  3. Reading and Mathematics Observation System: Description and Measurement of Time Usage in the Classroom.

    ERIC Educational Resources Information Center

    Calfee, Robert C.; Calfee, Kathryn Hoover

    The Beginning Teacher Evaluation Study, Phase II, was a research project on effective teaching behavior--what teachers do that significantly affects what and how pupils learn. The purposes of Phase II were to (1) develop an assessment system for measuring teacher and student behaviors and other factors which could influence each of them and their…

  4. An Investigation of the Reliability of Using Comparative Judgment to Score Creative Products

    ERIC Educational Resources Information Center

    Tarricone, Pina; Newhouse, C. Paul

    2017-01-01

    In this article we describe a three-year study that was conducted in three phases to evaluate the feasibility of assessing digitized portfolios of student creative work for high-stakes purposes. The first two phases suggested that creative work could be digitized with adequate fidelity, and that students could submit their own work from schools to…

  5. Short nights reduce light-induced circadian phase delays in humans.

    PubMed

    Burgess, Helen J; Eastman, Charmane I

    2006-01-01

    Short sleep episodes are common in modern society. We recently demonstrated that short nights reduce phase advances to light. Here we show that short nights also reduce phase delays to light. Two weeks of 6-hour sleep episodes in the dark (short nights) and 2 weeks of long 9-hour sleep episodes (long nights) in counterbalanced order, separated by 7 days. Following each series of nights, there was a dim-light phase assessment to assess baseline phase. Three days later, subjects were exposed to a phase-delaying light stimulus for 2 days, followed by a final phase assessment. Subjects slept at home in dark bedrooms but came to the laboratory for the phase assessments and light stimulus. Seven young healthy subjects. The 3.5-hour light stimulus was four 30-minute pulses of bright light (-5000 lux) separated by 30-minute intervals of room light. The stimulus began 2.5 hours after each subject's dim-light melatonin onset, followed by a 6- or 9-hour sleep episode. On the second night, the bright light and sleep episode began 1 hour later. The dim-light melatonin onset and dimlight melatonin offset phase delayed 1.4 and 0.7 hours less in the short nights, respectively (both p < or = .015). These results indicate for the first time that short nights can reduce circadian phase delays, that long nights can increase phase delays to light, or both. People who curtail their sleep may inadvertently reduce their circadian responsiveness to evening light.

  6. Oestrous phase cyclicity influences judgment biasing in rats.

    PubMed

    Barker, Timothy Hugh; Kind, Karen Lee; Groves, Peta Danielle; Howarth, Gordon Stanley; Whittaker, Alexandra Louise

    2018-04-10

    The identification of cognitive bias has become an important measure of animal welfare. Negative cognitive biases develop from a tendency for animals to process novel information pessimistically. Judgment-bias testing is the commonplace methodology to detect cognitive biases. However, concerns with these methods have been frequently-reported; one of which being the discrepancy between male and female cognitive expression. The current study assessed the factors of social status and oestrus, to investigate whether oestrous cycle rotation, or subordination stress encouraged an increase in pessimistic responses. Female Sprague-Dawley rats (n = 24) were trained on an active-choice judgment bias paradigm. Responses to the ambiguous probe were recorded as optimistic or pessimistic. Oestrous phase was determined by assessing vaginal cytology in stained vaginal cell smears. Rats in the dioestrous phase and those rats considered to be subordinate demonstrated an increased percentage of pessimistic responses. However, no interaction between these factors was observed. This suggests that oestrous cyclicity can influence the judgment biases of female animals; a previously unreported finding. On this basis, researchers should be encouraged to account for both oestrous phase cyclicity and social status as an additional fixed effect in study design. Crown Copyright © 2018. Published by Elsevier B.V. All rights reserved.

  7. Children and Young People-Mental Health Safety Assessment Tool (CYP-MH SAT) study: Protocol for the development and psychometric evaluation of an assessment tool to identify immediate risk of self-harm and suicide in children and young people (10-19 years) in acute paediatric hospital settings.

    PubMed

    Manning, Joseph C; Walker, Gemma M; Carter, Tim; Aubeeluck, Aimee; Witchell, Miranda; Coad, Jane

    2018-04-12

    Currently, no standardised, evidence-based assessment tool for assessing immediate self-harm and suicide in acute paediatric inpatient settings exists. The aim of this study is to develop and test the psychometric properties of an assessment tool that identifies immediate risk of self-harm and suicide in children and young people (10-19 years) in acute paediatric hospital settings. Development phase: This phase involved a scoping review of the literature to identify and extract items from previously published suicide and self-harm risk assessment scales. Using a modified electronic Delphi approach, these items will then be rated according to their relevance for assessment of immediate suicide or self-harm risk by expert professionals. Inclusion of items will be determined by 65%-70% consensus between raters. Subsequently, a panel of expert members will convene to determine the face validity, appropriate phrasing, item order and response format for the finalised items.Psychometric testing phase: The finalised items will be tested for validity and reliability through a multicentre, psychometric evaluation. Psychometric testing will be undertaken to determine the following: internal consistency, inter-rater reliability, convergent, divergent validity and concurrent validity. Ethical approval was provided by the National Health Service East Midlands-Derby Research Ethics Committee (17/EM/0347) and full governance clearance received by the Health Research Authority and local participating sites. Findings from this study will be disseminated to professionals and the public via peer-reviewed journal publications, popular social media and conference presentations. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  8. Physiological and psychological effects of testosterone during severe energy deficit and recovery: A study protocol for a randomized, placebo-controlled trial for Optimizing Performance for Soldiers (OPS).

    PubMed

    Pasiakos, Stefan M; Berryman, Claire E; Karl, J Philip; Lieberman, Harris R; Orr, Jeb S; Margolis, Lee M; Caldwell, John A; Young, Andrew J; Montano, Monty A; Evans, William J; Vartanian, Oshin; Carmichael, Owen T; Gadde, Kishore M; Harris, Melissa; Rood, Jennifer C

    2017-07-01

    The physiological consequences of severe energy deficit include hypogonadism and the loss of fat-free mass. Prolonged energy deficit also impacts physical performance, mood, attentiveness, and decision-making capabilities. This study will determine whether maintaining a eugonadal state during severe, sustained energy deficit attenuates physiological decrements and maintains mental performance. This study will also assess the effects of normalizing testosterone levels during severe energy deficit and recovery on gut health and appetite regulation. Fifty physically active men will participate in a 3-phase, randomized, placebo-controlled study. After completing a 14-d, energy-adequate, diet acclimation phase (protein: 1.6g∙kg -1 ∙d -1 ; fat: 30% total energy intake), participants will be randomized to undergo a 28-d, 55% energy deficit phase with (DEF+TEST: 200mg testosterone enanthate per week) or without (DEF) exogenous testosterone. Diet and physical activity will be rigorously controlled. Recovery from the energy deficit (ad libitum diet, no testosterone) will be assessed until body mass has been recovered within ±2.5% of initial body mass. Body composition, stable isotope methodologies, proteomics, muscle biopsies, whole-room calorimetry, molecular biology, activity/sleep monitoring, personality and cognitive function assessments, functional MRI, and comprehensive biochemistries will be used to assess physiological and psychological responses to energy restriction and recovery feeding while volunteers are in an expected hypogonadal versus eugonadal state. The Optimizing Performance for Soldiers (OPS) study aims to determine whether preventing hypogonadism will mitigate declines in physical and mental function that typically occur during prolonged energy deficit, and the efficacy of testosterone replacement on recovery from severe underfeeding. NCT02734238. Copyright © 2017. Published by Elsevier Inc.

  9. Delving into the environmental aspect of a Sardinian white wine: from partial to total life cycle assessment.

    PubMed

    Fusi, Alessandra; Guidetti, Riccardo; Benedetto, Graziella

    2014-02-15

    The aim of this study was to deepen the assessment of the environmental impacts of a white wine produced in Sardinia (FU 750 ml), performing an attributional LCA. The system boundaries were extended, from 'cradle to gate' (partial LCA) of a previous study, to 'cradle to grave' (total LCA), in order to identify the environmental impacts occurring along the wine life cycle stages (vine planting, grape production, wine production, bottling and packaging, distribution, final disposal of the glass bottle). Some assumptions were made in order to quantify the environmental impact of the transportation phase, regarding the few data which were available. Inventory data were mainly collected through direct communication with the Company involved in the study. Results showed that the environmental performance of wine was mostly determined by the glass bottle production (for all impact categories except ozone layer depletion). The second contributor was the agricultural phase, which included two sub-phases: vine planting and grape production. Results showed that the vine planting sub-phase was not negligible given its contribution to the agricultural phase, mainly due to diesel fuel consumption. Transportation impact was found to be relevant for long distance distribution (USA); the impact categories more affected by transport were acidification, eutrophication, photochemical oxidation and global warming potential. Suggested opportunities to reduce the overall environmental impact were the introduction of a lighter glass bottle or the substitution of the glass bottle with a polylaminate container. Copyright © 2013 Elsevier B.V. All rights reserved.

  10. An experimental investigation of preorgasmic reconditioning and postorgasmic deconditioning.

    PubMed Central

    Kantorowitz, D A

    1978-01-01

    The effects of pre- and postorgasmic presentation of moderately erotic cues were assessed in an analogue study. Eight heterosexual male volunteers (18 to 23 years) participated in three assessment (baseline, termination-of-treatment, and two- to three-month followup) and eight masturbatory conditioning sessions. Three slides of nude females of initially equal erotic value were paired respectively with the plateau, refractory, and resolution phases of the subjects' sexual cycles. Over treatment, stimuli paired with the plateau phase increased significantly in penile tumescence indices of eroticism; conversely, stimuli paired with the refractory phase decreased significantly. The conditioned effects on tumescence were largely extinguished at followup. While treatment did not alter short-term subjective indices of eroticism, stimuli presented during the refractory phase were rated significantly less erotic than the other stimuli at followup. The findings suggest that the "pairing" model of orgasmic conditioning is insufficient to account for previously reported clinical findings. A broader conceptualization of the mechanisms of orgasmic conditioning, and implications for treatment are discussed. PMID:649527

  11. An experimental investigation of preorgasmic reconditioning and postorgasmic deconditioning.

    PubMed

    Kantorowitz, D A

    1978-01-01

    The effects of pre- and postorgasmic presentation of moderately erotic cues were assessed in an analogue study. Eight heterosexual male volunteers (18 to 23 years) participated in three assessment (baseline, termination-of-treatment, and two- to three-month followup) and eight masturbatory conditioning sessions. Three slides of nude females of initially equal erotic value were paired respectively with the plateau, refractory, and resolution phases of the subjects' sexual cycles. Over treatment, stimuli paired with the plateau phase increased significantly in penile tumescence indices of eroticism; conversely, stimuli paired with the refractory phase decreased significantly. The conditioned effects on tumescence were largely extinguished at followup. While treatment did not alter short-term subjective indices of eroticism, stimuli presented during the refractory phase were rated significantly less erotic than the other stimuli at followup. The findings suggest that the "pairing" model of orgasmic conditioning is insufficient to account for previously reported clinical findings. A broader conceptualization of the mechanisms of orgasmic conditioning, and implications for treatment are discussed.

  12. Chemical partitioning for the Co--Pr system: First-principles, experiments and energetic calculations to investigate the hard magnetic phase

    DOE PAGES

    Zhou, S. H.; Kramer, M. J.; Meng, F. Q.; ...

    2015-11-14

    Co 5Pr-D2 d is promising permanent magnet. Due to its peritectic formation feature, there is a synthetic challenge to produce single Co 5Pr-D2 d phase. The object of our study is to assess thermodynamic pathways for crystalline phases under far-from-equilibrium conditions by combining first-principles calculations and experimental measurements into a robust description of the thermodynamic behavior. The energetic calculations, temperature and time dependent phase selections are predicted under varying degrees of chemical partitioning. Our calculation to assess the chemical partitioning-temperatures indicates that the major magnetic compounds: Co 17Pr 2-α, Co 5Pr-D2 d, Co 19Pr 5-β, and Co 7Pr 2-χ formmore » from a congruent manner to eutectic reactions with decreasing cooling rate. The compositions of the compounds from these highly driven liquids can be far from equilibrium.« less

  13. Standard operating procedure: implementation, critical analysis, and validation in the Audiology Department at CESTEH/Fiocruz.

    PubMed

    Freitas, Anelisse Vasco Mascarenhas de; Quixabeiro, Elinaldo Leite; Luz, Geórgia Rosangela Soares; Franco, Viviane Moreira; Santos, Viviane Fontes Dos

    2016-01-01

    Evaluate three standard operational procedures (SOPs), regarding the application of the brainstem auditory evoked potential (BAEP) test, implemented by the Audiology Department of the Center for Studies in Occupational Health and Human Ecology (CESTEH) through the application of a questionnaire and to verify whether the SOPs are effective and assess the necessity for improvement. The study was conducted in three phases: in the first phase, eight speech-language pathologists and seven physicians, with no experience in BAEP, were instructed to read and perform each SOP, eventually all individuals evaluated the SOPs by responding to a questionnaire; in the second phase, the questionnaires were analyzed and the three SOP texts were reviewed; in the third phase, nine speech-language pathologists and six physicians, also with no experience in BAEP, read and re-evaluated the reviewed SOPs through a questionnaire. In the first phase, difficulties in understanding the texts were found, raising doubts about the procedures; however, every participant was able to perform the procedure as a whole. In the third phase, after the review, all individuals were able to perform the procedures appropriately and continuously without any doubts. The assessment of the SOPs by questionnaires showed the need for adaptation in the texts. After the texts were reviewed according to the suggestions of the health professionals, it was possible to observe that the SOPs assisted in the execution of the task, which was conducted without any difficulties or doubts, being regarded effective and ensuring quality to the service offered.

  14. Quality of reporting in oncology phase II trials: A 5-year assessment through systematic review.

    PubMed

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

    2017-01-01

    Phase II clinical trials are a cornerstone of the development in experimental treatments They work as a "filter" for phase III trials confirmation. Surprisingly the attrition ratio in Phase III trials in oncology is significantly higher than in any other medical specialty. This suggests phase II trials in oncology fail to achieve their goal. Objective The present study aims at estimating the quality of reporting in published oncology phase II clinical trials. A literature review was conducted among all phase II and phase II/III clinical trials published during a 5-year period (2010-2015). All articles electronically published by three randomly-selected oncology journals with Impact-Factors>4 were included: Journal of Clinical Oncology, Annals of Oncology and British Journal of Cancer. Quality of reporting was assessed using the Key Methodological Score. 557 articles were included. 315 trials were single-arm studies (56.6%), 193 (34.6%) were randomized and 49 (8.8%) were non-randomized multiple-arm studies. The Methodological Score was equal to 0 (lowest level), 1, 2, 3 (highest level) respectively for 22 (3.9%), 119 (21.4%), 270 (48.5%) and 146 (26.2%) articles. The primary end point is almost systematically reported (90.5%), while sample size calculation is missing in 66% of the articles. 3 variables were independently associated with reporting of a high standard: presence of statistical design (p-value <0.001), multicenter trial (p-value = 0.012), per-protocol analysis (p-value <0.001). Screening was mainly performed by a sole author. The Key Methodological Score was based on only 3 items, making grey zones difficult to translate. This literature review highlights the existence of gaps concerning the quality of reporting. It therefore raised the question of the suitability of the methodology as well as the quality of these trials, reporting being incomplete in the corresponding articles.

  15. Assessment of the impact of the malaria elimination programme on the burden of disease morbidity in endemic areas of Iran.

    PubMed

    Sheikhzadeh, Khodadad; Haghdoost, Ali Akbar; Bahrampour, Abbas; Zolala, Farzaneh; Raeisi, Ahmad

    2016-04-14

    Controlling and preventive measures considerably reduced malaria incidence in Iran over the past few years, which confined the endemic areas to some regions in the southeastern Iran. The National Malaria Elimination Programme commenced in 2010. With regard to the presumption that the elimination programme interventions have accelerated the declining trend of malaria incidence across the endemic areas of Iran, the present study attempted to assess the effectiveness of the elimination programme by reviewing malaria incidence status, over a 14-year period, and comparing the trend of malaria incidence across malaria-endemic areas between the control and pre-elimination phase, and the elimination phase. A retrospective analysis of malaria surveillance data was conducted in a 14-year period (2001-2014), using multilevel Poisson regression. The epidemiological malaria maps and indicators also were developed and compared between the control and pre-elimination phase, and the elimination phase. The mean of malaria incidence was 2.2 (1.7-2.7) for the entire study period. This rate was 3.4 (2.6-4.1) in the control and pre-elimination phase, and 0.41 (0.25-0.57) for the elimination phase. During the malaria elimination phase, the decline of annual malaria incidence had significantly accelerated and autochthonous cases had the greatest difference in malaria incidence decline (compared to the control and pre-elimination phase), whereas, falciparum cases had the lowest difference in malaria incidence decline, followed by non-Iranian and imported cases. Furthermore, there was a decline in Iranians to non-Iranians ratio and an increase in the ratios of over 15 to under 15, as well as male to female, in the elimination phase in comparison to the control and pre-elimination phase. It seems that the decline of malaria transmission, which has been initiated over the past few years, has accelerated as a result of the elimination programme, and Iran is approaching the goals set regarding the elimination of this disease.

  16. Phase 1 trial of adalimumab in Focal Segmental Glomerulosclerosis (FSGS): II. Report of the FONT (Novel Therapies for Resistant FSGS) study group.

    PubMed

    Joy, Melanie S; Gipson, Debbie S; Powell, Leslie; MacHardy, Jacqueline; Jennette, J Charles; Vento, Suzanne; Pan, Cynthia; Savin, Virginia; Eddy, Allison; Fogo, Agnes B; Kopp, Jeffrey B; Cattran, Daniel; Trachtman, Howard

    2010-01-01

    Patients with primary focal segmental glomerulosclerosis (FSGS) resistant to current treatment regimens are at high risk of progression to end-stage kidney disease. Antifibrotic agents, such as tumor necrosis factor alpha antagonists, are a promising strategy to slow or halt the decline in renal function, based on preclinical and clinical data. Phase 1 clinical trial to assess the pharmacokinetics, tolerability, and safety of adalimumab, a human monoclonal antibody to tumor necrosis factor alpha. 10 patients (4 male and 6 female) aged 16.8 +/- 9.0 years with an estimated glomerular filtration rate of 105 +/- 50 mL/min/1.73 m(2) were studied. Adalimumab, 24 mg/m(2), every 14 days for 16 weeks (total, 9 doses). Pharmacokinetic assessment, tolerability, and safety. Estimated glomerular filtration rate, proteinuria, and pharmacokinetic assessment after initial dosing and steady state. Pharmacokinetic evaluation indicated that the area under the curve was decreased by 54% (P < 0.001) and clearance was increased by 160% (P < 0.01) in patients with resistant FSGS compared with healthy controls and patients with rheumatoid arthritis. Adalimumab was well tolerated with no serious adverse events or infectious complications attributable to the drug. Proteinuria decreased by > or = 50% in 4 of 10 treated patients. Insufficient power to assess the safety or efficacy of adalimumab therapy for patients with resistant FSGS. Pharmacokinetic assessment showed increased clearance of adalimumab in patients with resistant primary FSGS and validated the need to evaluate the disposition of novel therapies for this disease to define appropriate dosing regimens. The study provides a rationale to evaluate the efficacy of adalimumab as an antifibrotic agent for resistant FSGS in phase 2/3 clinical trials. Copyright 2009 National Kidney Foundation, Inc. All rights reserved.

  17. Glass Formation, Phase Equilibria, and Thermodynamic Assessment of the Al-Ce-Co System Assisted by First-Principles Energy Calculations

    NASA Astrophysics Data System (ADS)

    Gao, Michael C.; Ünlü, Necip; Mihalkovic, Marek; Widom, Michael; Shiflet, G. J.

    2007-10-01

    This study investigates glass formation, phase equilibria, and thermodynamic descriptions of the Al-rich Al-Ce-Co ternary system using a novel approach that combines critical experiments, CALPHAD modeling, and first-principles (FP) calculations. The glass formation range (GFR) and a partial 500 °C isotherm are determined using a range of experimental techniques including melt spinning, transmission electron microscopy (TEM), electron probe microanalysis (EPMA), X-ray diffraction, and differential thermal analysis (DTA). Three stable ternary phases are confirmed, namely, Al8CeCo2, Al4CeCo, and AlCeCo, while a metastable phase, Al5CeCo2, was discovered. The equilibrium and metastable phases identified by the present and earlier reported experiments, together with many hypothetical ternary compounds, are further studied by FP calculations. Based on new experimental data and FP calculations, the thermodynamics of the Al-rich Al-Co-Ce system is optimized using the CALPHAD method. Application to glass formation is discussed in light of present studies.

  18. Endogenous inhibition of pain and spinal nociception in women with premenstrual dysphoric disorder

    PubMed Central

    Palit, Shreela; Bartley, Emily J; Kuhn, Bethany L; Kerr, Kara L; DelVentura, Jennifer L; Terry, Ellen L; Rhudy, Jamie L

    2016-01-01

    Purpose Premenstrual dysphoric disorder (PMDD) is characterized by severe affective and physical symptoms, such as increased pain, during the late-luteal phase of the menstrual cycle. The mechanisms underlying hyperalgesia in women with PMDD have yet to be identified, and supraspinal pain modulation has yet to be examined in this population. The present study assessed endogenous pain inhibitory processing by examining conditioned pain modulation (CPM, a painful conditioning stimulus inhibiting pain evoked by a test stimulus at a distal body site) of pain and the nociceptive flexion reflex (NFR, a spinally-mediated withdrawal reflex) during the mid-follicular, ovulatory, and late-luteal phases of the menstrual cycle. Methods Participants were regularly-cycling women (14 without PMDD; 14 with PMDD). CPM was assessed by delivering electrocutaneous test stimuli to the sural nerve before, during, and after a painful conditioning ischemia task. Participants rated their pain to electrocutaneous stimuli, and NFR magnitudes were measured. A linear mixed model analysis was used to assess the influence of group and menstrual phase on CPM. Results Compared with controls, women with PMDD experienced greater pain during the late-luteal phase and enhanced spinal nociception during the ovulation phase, both of which were independent of CPM. Both groups showed CPM inhibition of pain that did not differ by menstrual phase. Only women with PMDD evidenced CPM inhibition of NFR. Conclusion Endogenous modulation of pain and spinal nociception is not disrupted in women with PMDD. Additionally, greater NFR magnitudes during ovulation in PMDD may be due to tonically-engaged descending mechanisms that facilitate spinal nociception, leading to enhanced pain during the premenstrual phase. PMID:26929663

  19. A Systems Engineering Approach to Define the Fundamental Process for Phase 0/Steady State Theater-Level Strategic Assessments

    DTIC Science & Technology

    2012-06-01

    assessment, and the relationship between the investment of U.S. resources and the desired strategic outcomes. This study will be translated into...group 23 was not possible, so an interview with Mr. Mark Bellchambers from Noetic Group occurred on December 1, 2011. His work involves improving the...strategic assessment abilities for all of the COCOMS, via consultation with COCOMs and OSD. His knowledge in this study allows him to be

  20. Validity, reliability and responsiveness to change of the Italian palliative care outcome scale: a multicenter study of advanced cancer patients.

    PubMed

    Costantini, Massimo; Rabitti, Elisa; Beccaro, Monica; Fusco, Flavio; Peruselli, Carlo; La Ciura, Pietro; Valle, Alessandro; Suriani, Cinzia; Berardi, Maria Alejandra; Valenti, Danila; Mosso, Felicita; Morino, Piero; Zaninetta, Giovanni; Tubere, Giorgio; Piazza, Massimo; Sofia, Michele; Di Leo, Silvia; Higginson, Irene J

    2016-02-26

    There is an increasing requirement to assess outcomes, but few measures have been tested for advanced medical illness. We aimed to test the validity, reliability and responsiveness of the Palliative care Outcome Scale (POS), and to analyse predictors of change after the transition to palliative care. Phase 1: multicentre, mixed method study comprising cognitive and qualitative interviews with patients and staff, cultural refinement and adaption. Phase 2: consecutive cancer patients on admission to 8 inpatient hospices and 7 home-based teams were asked to complete the POS, the EORTC QLQ-C15-PAL and the FACIT-Sp (T0), to assess internal consistency, convergent and divergent validity. After 6 days (T1) patients and staff completed the POS to assess responsiveness to change (T1-T0), and agreement between self-assessed POS and POS completed by the staff. Finally, we asked hospices an assessment 24-48 h after T1 to assess its reliability (test re-test analysis). Phase I: 209 completed POS questionnaires and 29 cognitive interviews were assessed, revisions made and one item substituted. Phase II: 295 consecutive patients admitted to 15 PCTs were approached, 175 (59.3 %) were eligible, and 150 (85.7 %) consented. Consent was limited by the severity of illness in 40 % patients. We found good convergent validity, with strong and moderate correlations (r ranged 0.5-0.8) between similar items from the POS, the QLQ-C15-PAL and the FACIT-Sp. As hypothesised, the physical function subscale of QLQ-C15-PAL was not correlated with any POS item (r ranged -0.16-0.02). We found acceptable to good test re-test reliability in both versions for 6 items. We found significant clinical improvements during the first week of palliative care in 7/10 items assessed-pain, other symptoms, patient and family anxiety, information, feeling at peace and wasted time. Both the patient self-assessed and professional POS versions are valid and with an acceptable internal consistency. POS detected significant clinical improvements during palliative care, at a time when patients are usually expected to deteriorate. These results suggest that there is room for substantial improvement in the management of patients with advanced disease, across all key domains-symptoms, psychological, information, social and spiritual.

  1. Instrumentation and computational modeling for evaluation of bridges substructures across waterways.

    DOT National Transportation Integrated Search

    2013-12-01

    This State Study 229 was proposed as the Phase I study for implementing sensing technologies and computational analysis to assess bridge conditions and support decision-making for bridge maintenance in Mississippi. The objectives of the study are to:...

  2. Time series of ground reaction forces following a single leg drop jump landing in elite youth soccer players consist of four distinct phases.

    PubMed

    Fransz, Duncan P; Huurnink, Arnold; de Boode, Vosse A; Kingma, Idsart; van Dieën, Jaap H

    2016-10-01

    The single leg drop jump landing test may assess dynamic and static balance abilities in different phases of the landing. However objective definitions of different phases following landing and associated reliability are lacking. Therefore, we determined the existence of possible distinct phases of single leg drop jump landing on a force plate in 82 elite youth soccer players. Three outcome measures were calculated over moving windows of five sizes: center of pressure (COP) speed, COP sway and horizontal ground reaction force (GRF). Per outcome measure, a Factor Analysis was employed with all windows as input variables. It showed that four factors (patterns of variance) largely (>75%) explained the variance across subjects/trials along the 12s time series. Each factor was highly associated with a distinct phase of the time series signal: dynamic (0.4-2.7s), late dynamic (2.5-5.0s), static 1 (5.0-8.3s) and static 2 (8.1-11.7s). Intra-class correlations (ICC) between trials were lower for the dynamic phases (0.45-0.68) than for the static phases (0.60-0.86). The COP speed showed higher ICC's (0.63-0.86) than COP sway (0.45-0.61) and GRF (0.57-0.71) for all four phases. In conclusion, following a drop jump landing unique information is available in four distinct phases. The COP speed is most reliable, with higher reliability in the static phases compared to the dynamic phases. Future studies should assess the sensitivity of information from dynamic, late dynamic and static phases. Copyright © 2016 Elsevier B.V. All rights reserved.

  3. Incidental encoding of emotional pictures: affective bias studied through event related brain potentials.

    PubMed

    Tapia, Manuel; Carretié, Luis; Sierra, Benjamín; Mercado, Francisco

    2008-06-01

    Emotional stimuli are better remembered than neutral stimuli. Most of the studies taking into account this emotional bias refer to explicit memory, use behavioral measures of the recall and predict better recall of negative stimuli. The few studies taking into account implicit memory and the valence emotional dimension are inconclusive on the effect of the stimulus' emotional valence. In the present study, 120 pictures (30 positive, 30 negative, 30 relaxing and 30 neutral) were shown to, and assessed by, 28 participants (study phase). Subsequently, event related brain potentials (ERPs) were recorded during the presentation of 120 new (shown for the first time) and 120 old (already shown in the study phase) pictures (test phase). No explicit instructions or clues related to recovery were given to participants, and a distractor task was employed, in order to maintain implicit the memory assessment. As expected from other studies' data, our results showed that old stimuli elicited an enhanced late positive component 450 ms after stimulus onset (repetition effect). Moreover, this effect was modulated by the stimuli's emotional valence, since the most positively valenced stimuli were associated with a decreased repetition effect with respect to the most negatively valenced stimuli. This effect was located at ventromedial prefrontal cortex. These results suggest the existence of a valence-mediated bias in implicit memory.

  4. Can Circadian Dysregulation Exacerbate Migraines?

    PubMed

    Ong, Jason C; Taylor, Hannah L; Park, Margaret; Burgess, Helen J; Fox, Rina S; Snyder, Sarah; Rains, Jeanetta C; Espie, Colin A; Wyatt, James K

    2018-05-04

    This observational pilot study examined objective circadian phase and sleep timing in chronic migraine (CM) and healthy controls (HC) and the impact of circadian factors on migraine frequency and severity. Sleep disturbance has been identified as a risk factor in the development and maintenance of CM but the biological mechanisms linking sleep and migraine remain largely theoretical. Twenty women with CM and 20 age-matched HC completed a protocol that included a 7 day sleep assessment at home using wrist actigraphy followed by a circadian phase assessment using salivary melatonin. We compared CM vs HC on sleep parameters and circadian factors. Subsequently, we examined associations between dim-light melatonin onset (DLMO), the midpoint of the sleep episode, and the phase angle (time from DLMO to sleep midpoint) with the number of migraine days per month and the migraine disability assessment scale (MIDAS). CM and HC did not differ on measures of sleep or circadian phase. Within the CM group, more frequent migraine days per month was significantly correlated with DLMO (r = .49, P = .039) and later sleep episode (r = .47, P = .037). In addition, a greater phase angle (ie, circadian misalignment) was significantly correlated with more severe migraine-related disability (r = .48, P = .042). These relationships remained significant after adjusting for total sleep time. This pilot study revealed that circadian misalignment and delayed sleep timing are associated with higher migraine frequency and severity, which was not better accounted for by the amount of sleep. These findings support the plausibility and need for further investigation of a circadian pathway in the development and maintenance of chronic headaches. Specifically, circadian misalignment and delayed sleep timing could serve as an exacerbating factor in chronic migraines when combined with biological predispositions or environmental factors. © 2018 American Headache Society.

  5. Developing a pilot curriculum to foster humanism among graduate medical trainees

    PubMed Central

    Dotters-Katz, Sarah K.; Chuang, Alice; Weil, Amy; Howell, Jennifer O.

    2018-01-01

    BACKGROUND: Humanism is a central tenant of professionalism, a required competency for all residency programs. Yet, few residencies have formal curriculum for teaching this critical aspect of medicine. Instead, professionalism and humanism are often taught informally through role-modeling. With increased burnout, faculty professionalism may suffer and may compromise resident role-modeling. The objective of this study was to design a pilot curriculum to foster humanism in among residents and assess its ability to do so. MATERIALS AND METHODS: Two-phase exploratory sequential mixed methods study. Phase 1: a qualitative analysis of residents’ narratives regarding challenges to humanistic behavior, and identified themes of compassion, fatigue, communication challenges, and work-life balance. Themes used as needs assessment to build curriculum. Phase 2: three sessions with themes taken from faculty development course. Participants and controls completed baseline and 60-day follow-up questionnaires assessing burnout, compassion, satisfaction, and ability to practice psychological medicine. Phase one included Obstetrics/Gynecology and internal medicine residents. Phase two included residents from the above programs, who attended at least 2/3 interactive sessions designed to address the themes identified above. RESULTS: Twelve participants began and ten completed curriculum (83%). The curriculum met course objectives and was well-received (4.8/5). Burnout decreased (−3.1 vs. 2.5, P = 0.048). A trend toward improved compassion (4.4 vs.−0.6, P = 0.096) for participants compared to controls was noted. CONCLUSION: A pilot humanism curriculum for residents was well-received. Participants showed decreased burnout and trended to improved compassion scores. Development and evaluation of an expanded curriculum would further explore feasibility and effectiveness of the intervention. PMID:29417062

  6. Technical Overview of Ecological Risk Assessment - Analysis Phase: Exposure Characterization

    EPA Pesticide Factsheets

    Exposure Characterization is the second major component of the analysis phase of a risk assessment. For a pesticide risk assessment, the exposure characterization describes the potential or actual contact of a pesticide with a plant, animal, or media.

  7. A Risk Management Framework to Characterize Black Swan Risks: A Case Study of Lightning Effects on Insensitive High Explosives

    NASA Astrophysics Data System (ADS)

    Sanders, Gary A.

    Effective and efficient risk management processes include the use of high fidelity modeling and simulation during the concept exploration phase as part of the technology and risk assessment activities, with testing and evaluation tasks occurring in later design development phases. However, some safety requirements and design architectures may be dominated by the low probability/high consequence "Black Swan" vulnerabilities that require very early testing to characterize and efficiently mitigate. Failure to address these unique risks has led to catastrophic systems failures including the space shuttle Challenger, Deepwater Horizon, Fukushima nuclear reactor, and Katrina dike failures. Discovering and addressing these risks later in the design and development process can be very costly or even lead to project cancellation. This paper examines the need for risk management process adoption of early hazard phenomenology testing to inform the technical risk assessment, requirements definition and conceptual design. A case study of the lightning design vulnerability of the insensitive high explosives being used in construction, mining, demolition, and defense industries will be presented to examine the impact of this vulnerability testing during the concept exploration phase of the design effort. While these insensitive high explosives are far less sensitive to accidental initiation by fire, impact, friction or even electrical stimuli, their full range of sensitivities have not been characterized and ensuring safe engineering design and operations during events such as lightning storms requires vulnerability testing during the risk assessment phase.

  8. Army Enlisted Personnel Competency Assessment Program: Phase 2 Report

    DTIC Science & Technology

    2006-01-01

    benefit analysis of a notional Army program will be conducted. v Findings: The prototype Army core assessment was successfully administered to over 600...about competency assessment. They will also be incorporated into a cost and benefit analysis to be conducted in Phase III. vi CONTENTS Page Chapter 1...Conduct a Cost- Benefit Analysis, and Make System Recommendations Phase I of PerformM21 resulted in program design recommendations that included such

  9. Air Sea Battle Intelligence, Surveillance, and Reconnaissance Concept of Operations: Getting Back to Fundamentals

    DTIC Science & Technology

    2012-05-08

    Assessment” phase. This phase will be constant throughout the AirSea Battle. A subset of this phase includes battle damage assessment ( BDA ). BDA ...taskings for assessment. There may be situations where operations will cease until the proper BDA is desired. This possibility directly... BDA assessments. It is paramount to task fifth generation fighter with this mission set due to their advanced capabilities. 15 The USAF and USN

  10. e-Health preparedness assessment in the context of an influenza pandemic: a qualitative study in China.

    PubMed

    Li, Junhua; Seale, Holly; Ray, Pradeep; Wang, Quanyi; Yang, Peng; Li, Shuang; Zhang, Yi; Macintyre, C Raina

    2013-03-13

    To assess the preparedness status of a hospital in Beijing, China for implementation of an e-Health system in the context of a pandemic response. This research project used qualitative methods and involved two phases: (1) group interviews were conducted with key stakeholders to examine how the surveillance system worked with information and communication technology (ICT) support in Beijing, the results of which provided background information for a case study at the second phase and (2) individual interviews were conducted in order to gather a rich data set in relation to e-Health preparedness at the selected hospital. In phase 1, group interviews were conducted at Centres for Disease Prevention and Control (CDC) in Beijing. In phase 2, individual interviews were performed at a secondary hospital selected for the case study. In phase 1, three group interviews were undertaken with 12 key stakeholders (public health/medical practitioners from the Beijing city CDC, two district CDCs and a tertiary hospital) who were involved in the 2009 influenza A (H1N1) pandemic response in Beijing. In phase 2, individual interviews were conducted with 23 participants (including physicians across medical departments, an IT manager and a general administrative officer). PRIMARY AND SECONDARY MEASURES: For the case study, five areas were examined to assess the hospital's preparedness for implementation of an e-Health system in the context of a pandemic response: (1) motivational forces for change; (2) healthcare providers' exposure to e-Health; (3) technological preparedness; (4) organisational non-technical ability to support a clinical ICT innovation and (5) sociocultural issues at the organisation in association with e-Health implementation and a pandemic response. This article reports a small subset of the case study results from which major issues were identified under three main themes in relation to the hospital's preparedness. These issues include a poor sharing of patient health records, prescription errors, unavailability of software tools to assist physicians in answering patient questions, physicians' concerns about the reliability of ICT and the high monetary cost of e-health implementation and uncertainty over return on investment, and their dissatisfaction with the software in use. Prior to the implementation of e-Health, planning must be undertaken to ensure the smooth introduction of the system. The assessment of organisational preparedness is an important step in this planning process. On the basis of a case study, deficient areas of organisational preparedness were identified for the prospective implementation of electronic health records. Accordingly, we suggested possible solutions for the areas in need of improvement to facilitate e-Health implementation's success.

  11. e-Health preparedness assessment in the context of an influenza pandemic: a qualitative study in China

    PubMed Central

    Li, Junhua; Seale, Holly; Ray, Pradeep; Wang, Quanyi; Yang, Peng; Li, Shuang; Zhang, Yi; MacIntyre, C Raina

    2013-01-01

    Objective To assess the preparedness status of a hospital in Beijing, China for implementation of an e-Health system in the context of a pandemic response. Design This research project used qualitative methods and involved two phases: (1) group interviews were conducted with key stakeholders to examine how the surveillance system worked with information and communication technology (ICT) support in Beijing, the results of which provided background information for a case study at the second phase and (2) individual interviews were conducted in order to gather a rich data set in relation to e-Health preparedness at the selected hospital. Setting In phase 1, group interviews were conducted at Centres for Disease Prevention and Control (CDC) in Beijing. In phase 2, individual interviews were performed at a secondary hospital selected for the case study. Participants In phase 1, three group interviews were undertaken with 12 key stakeholders (public health/medical practitioners from the Beijing city CDC, two district CDCs and a tertiary hospital) who were involved in the 2009 influenza A (H1N1) pandemic response in Beijing. In phase 2, individual interviews were conducted with 23 participants (including physicians across medical departments, an IT manager and a general administrative officer). Primary and secondary measures For the case study, five areas were examined to assess the hospital's preparedness for implementation of an e-Health system in the context of a pandemic response: (1) motivational forces for change; (2) healthcare providers’ exposure to e-Health; (3) technological preparedness; (4) organisational non-technical ability to support a clinical ICT innovation and (5) sociocultural issues at the organisation in association with e-Health implementation and a pandemic response. Results This article reports a small subset of the case study results from which major issues were identified under three main themes in relation to the hospital's preparedness. These issues include a poor sharing of patient health records, prescription errors, unavailability of software tools to assist physicians in answering patient questions, physicians’ concerns about the reliability of ICT and the high monetary cost of e-health implementation and uncertainty over return on investment, and their dissatisfaction with the software in use. Conclusions Prior to the implementation of e-Health, planning must be undertaken to ensure the smooth introduction of the system. The assessment of organisational preparedness is an important step in this planning process. On the basis of a case study, deficient areas of organisational preparedness were identified for the prospective implementation of electronic health records. Accordingly, we suggested possible solutions for the areas in need of improvement to facilitate e-Health implementation's success. PMID:23485719

  12. Student Perceptions and Use of an Assessment Rubric for a Group Concept Map in Physiology

    ERIC Educational Resources Information Center

    Moni, Roger W.; Moni, Karen B.

    2008-01-01

    We previously reported how the opinions of second-year dentistry students and faculty members can be used to construct an assessment rubric to grade group-based concept maps in physiology (14). This article describes the second phase of this study of the subsequent year's cohort. A case study approach was used to investigate how groups of students…

  13. Solar power satellite system definition study. Volume 1, phase 1: Executive summary

    NASA Technical Reports Server (NTRS)

    1979-01-01

    A systems definition study of the solar satellite system (SPS) is presented. The technical feasibility of solar power satellites based on forecasts of technical capability in the various applicable technologies is assessed. The performance, cost, operational characteristics, reliability, and the suitability of SPS's as power generators for typical commercial electricity grids are discussed. The uncertainties inherent in the system characteristics forecasts are assessed.

  14. Initial Development of a Cultural Values and Beliefs Scale among Dakota/Nakota/Lakota People: A Pilot Study

    ERIC Educational Resources Information Center

    Reynolds, W. Rusty; Quevillon, Randal P.; Boyd, Beth; Mackey, Duane

    2006-01-01

    This study was the initial phase in the development of a mental health assessment tool. The Native American Cultural Values and Beliefs Scale is a 12-item instrument that assesses three dimensions of American Indian/Alaska Native values and beliefs: 1) the importance, 2) the frequency of practicing, and 3) the amount of distress caused by not…

  15. Organisational justice and change in justice as predictors of employee health: the Whitehall II study.

    PubMed

    Kivimäki, Mika; Ferrie, Jane E; Head, Jenny; Shipley, Martin J; Vahtera, Jussi; Marmot, Michael G

    2004-11-01

    Organisational justice has been proposed as a new way to examine the impact of psychosocial work environment on employee health. This article studied the justice of interpersonal treatment by supervisors (the relational component of organisational justice) as a predictor of health. Prospective cohort study. Phase 1 (1985-88) measured relational justice, job demands, job control, social support at work, effort-reward imbalance, and self rated health. Relational justice was assessed again at phase 2 (1989-90) and self rated health at phase 2 and phase 3 (1991-93). 20 civil service departments originally located in London. 10 308 civil servants (6895 men, 3413 women) aged 35-55. Self rated health. Men exposed to low justice at phase 1 or adverse change in justice between phase 1 and phase 2 were at higher risk of poor health at phase 2 and phase 3. A favourable change in justice was associated with reduced risk. Adjustment for other stress indicators had little effect on results. In women, low justice at phase 1 predicted poor health at phase 2 and phase 3 before but not after adjustment for other stress indicators. Adverse change in justice was associated with worse health prospects irrespective of adjustments. The extent to which people are treated with justice in workplaces seems to predict their health independently of established stressors at work. Evidence on reduced health risk after favourable change in organisational justice implies a promising area for health interventions at workplace.

  16. Thai-Alberta Co-Operative Assessment Project Concerning Thirty-Two Rural Secondary Schools in the Third National Economic and Social Plan, Thailand (1972-1976). Final Report.

    ERIC Educational Resources Information Center

    Chareonchai, Ruang; And Others

    This extensive assessment project report focuses on the Rural Secondary Schools (RSS) Project in Thailand. The background, design, rationale and objectives of the assessment are described, as are the eight phases of the study: reconnaissance; proposals; basic planning and pre-testing; data collection; analysis; academic review; final report; and…

  17. Finite element 3D modeling of mechanical behavior of mineralized collagen microfibrils.

    PubMed

    Barkaoui, Abdelwahed; Hambli, Ridha

    2011-01-01

    The aim of this work is to develop a 3D finite elements model to study the nanomechanical behavior of mineralized collagen microfibrils, which consists of three phases, (i) collagen phase formed by five tropocollagen (TC) molecules linked together with cross-links, (ii) a mineral phase (Hydroxyapatite), and (iii) impure mineral phase, and to investigate the important role of individual properties of every constituent. The mechanical and geometric properties (TC molecule diameter) of both tropocollagen and mineral were taken into consideration as well as cross-links, which was represented by spring elements with adjusted properties based on experimental data. In this paper an equivalent homogenized model was developed to assess the whole microfibril mechanical properties (Young's modulus and Poisson's ratio) under varying mechanical properties of each phase. In this study, both equivalent Young's modulus and Poisson's ratio, which were expressed as functions of Young's modulus of each phase, were obtained under tensile load with symmetric and periodic boundary conditions.

  18. A psychological approach to providing self-management education for people with type 2 diabetes: the Diabetes Manual

    PubMed Central

    Sturt, Jackie; Taylor, Hafrun; Docherty, Andrea; Dale, Jeremy; Louise, Taylor

    2006-01-01

    Background The objectives of this study were twofold (i) to develop the Diabetes Manual, a self-management educational intervention aimed at improving biomedical and psychosocial outcomes (ii) to produce early phase evidence relating to validity and clinical feasibility to inform future research and systematic reviews. Methods Using the UK Medical Research Council's complex intervention framework, the Diabetes Manual and associated self management interventions were developed through pre-clinical, and phase I evaluation phases guided by adult-learning and self-efficacy theories, clinical feasibility and health policy protocols. A qualitative needs assessment and an RCT contributed data to the pre-clinical phase. Phase I incorporated intervention development informed by the pre-clinical phase and a feasibility survey. Results The pre-clinical and phase I studies resulted in the production in the Diabetes Manual programme for trial evaluation as delivered within routine primary care consultations. Conclusion This complex intervention shows early feasibility and face validity for both diabetes health professionals and people with diabetes. Randomised trial will determine effectiveness against clinical and psychological outcomes. Further study of some component parts, delivered in alternative combinations, is recommended. PMID:17129376

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

    Ortiz, E.; Kraatz, M.; Luthy, R.G.

    The dissolution of naphthalene, phenanthrene, and pyrene from viscous organic phases into water was studied in continuous-flow systems for time periods ranging from several months to more than 1 year. By selecting nonaqueous phases ranging from low viscosity to semisolid, i.e., from a light lubricating oil to paraffin, the governance of mass transfer was shown to vary from water phase control to nonaqueous phase control. An advancing depleted-zone model is proposed to explain the dissolution of PAHs from a viscous organic phase wherein the formation of a depleted zone within the organic phase increases the organic phase resistance to themore » dissolution of PAHs. The experimental data suggest the formation of a depleted zone within the organic phase for systems comprising a high-viscosity oil, petrolatum (petroleum jelly), and paraffin. Organic phase resistance to naphthalene dissolution became dominant over aqueous phase resistance after flushing for several days. Such effects were not evident for low viscosity lubricating oil. The transition from aqueous-phase dissolution control to nonaqueous-phase dissolution control appears predictable, and this provides a more rational framework to assess long-term release of HOCs from viscous nonaqueous phase liquids and semisolids.« less

  20. Seeing is believing? A mixed-methods study exploring the quality and perceived trustworthiness of online information about chronic conditions aimed at children and young people.

    PubMed

    McPherson, Amy C; Gofine, Miriam L; Stinson, Jennifer

    2014-01-01

    The numbers of children and young people with chronic conditions are increasing. While their information needs may vary, providing health care information can have considerable benefits, including better emotional health, less distress during treatments, and greater satisfaction with medical care. The Internet is increasingly being used to communicate health-related information to children about a range of chronic conditions. However, the quality of such websites is underexplored. Thus, the objectives of this study were to evaluate the reliability and quality of online information for children about chronic conditions using a standardized evaluation tool, and to explore children's and young people's perceptions of quality and trustworthiness regarding online health information. The study consisted of two phases. In Phase 1, websites about common pediatric chronic conditions aimed at children and containing treatment or management options were identified and the quality assessment tool DISCERN was completed. Test-retest and interrater reliability were calculated. In Phase 2, two focus groups with laptop computers were conducted with children and young people with a chronic condition to explore their perceptions of trustworthiness of online health information. In Phase 1, 165 websites were identified and 100 met the criteria and were assessed. The mean DISCERN score of all sites was 48.16 out of 75 (SD = 7.97, range 28-71, min 15 to max 75). Quality scores varied widely across the sample. The internal consistency and interrater reliability scores were both lower than previously reported in studies using the DISCERN to assess information for adults. In Phase 2, two focus groups with a total of six participants aged 11-23 years revealed a relative lack of concern about the quality and trustworthiness of online health information. Older participants reported judging the source and authorship of websites, but other participants did not question the source of the information they found online. Although personal websites were perceived to be less reliable than those from well-known medical institutions, they were still valued by many of the participants. Overall, there were relatively few websites about pediatric chronic conditions aimed at children, with variable quality and reliability. However, DISCERN's use with pediatric websites across a broad spectrum of developmental stages is limited. Children and young people demonstrated a need for more guidance around assessing trustworthiness of online information. A more appropriate quality assessment tool is warranted, which could usefully be employed by health care professionals, children, and parents.

  1. Evaluation of the appropriateness of the preclinical phase (stage A and stage B) of heart failure Management in Outpatient clinics in Italy rationale and design of the 'VASTISSIMO' study.

    PubMed

    Mureddu, Gian F; Nistri, Stefano; Faggiano, Pompilio; Fimiani, Biagio; Misuraca, Gianfranco; Maggi, Antonio; Gori, Anna M; Uguccioni, Massimo; Tavazzi, Luigi; Zito, Giovanni B

    2016-07-01

    Early detection of heart failure, when still preclinical, is fundamental. Therefore, it is important to assess whether preclinical heart failure management by cardiologists is adequate. The VASTISSIMO study ('EValuation of the AppropriateneSs of The preclInical phase (Stage A and Stage B) of heart failure Management in Outpatient clinics in Italy') is a prospective nationwide study aimed to evaluate the appropriateness of diagnosis and management of preclinical heart failure (stages A and B) by cardiologists working in outpatient clinics in Italy. Secondary goals are to verify if an online educational course for cardiologists can improve management of preclinical heart failure, and evaluate how well cardiologists are aware of patients' adherence to medications. The study involves 80 outpatient cardiology clinics distributed throughout Italy, affiliated either to the Hospital Cardiologists Association or to the Regional Association of Outpatient Cardiologists, and is designed with two phases of consecutive outpatient enrolment each lasting 1 month. In phase 1, physicians' awareness of the risk of heart failure and their decision-making process are recorded. Subsequently, half of the cardiologists are randomized to undergo an online educational course aimed to improve preclinical heart failure management through implementation of guideline recommendations. At the end of the course, all cardiologists are evaluated (phase 2) to see whether changes in clinical management have occurred in those who underwent the educational program versus those who did not. Patients' adherence to prescribed medications will be assessed through the Morisky Self-report Questionnaire. This study should provide valuable information about cardiologists' awareness of preclinical heart failure and the appropriateness of clinical practice in outpatient cardiology clinics in Italy.

  2. Methodology of phase II clinical trials in metastatic elderly breast cancer: a literature review.

    PubMed

    Cabarrou, B; Mourey, L; Dalenc, F; Balardy, L; Kanoun, D; Roché, H; Boher, J M; Rougé-Bugat, M E; Filleron, Thomas

    2017-08-01

    As the incidence of invasive breast cancer will increase with age, the number of elderly patients with a diagnosis metastatic breast cancer will also rise. But the use of cytotoxic drugs in elderly metastatic breast cancer patients is not systematic and is dreaded by medical oncologists. The need for prospective oncologic data from this population seems increasingly obvious. The main objective of this review is to investigate design and characteristics of phase II trials that assess activity and feasibility of chemotherapies in elderly advanced/metastatic breast cancer patients. An electronic search in PUBMED allowed us to retrieve articles published in English language on phase II trials in elderly metastatic breast cancer between January 2002 and May 2016. Sixteen publications were finally included in this review. The primary endpoint was a simple, a composite, and a co-primary endpoints in 11, three, and two studies, respectively. Efficacy was the primary objective in 15 studies: simple (n = 10), composite (n = 3), co-primary endpoints (n = 2). Composite or co-primary endpoints combined efficacy and toxicity. Thirteen studies used multistage designs. Only five studies evaluated the feasibility, i.e., to jointly assess efficacy and tolerance to treatment (toxicity, quality of life, etc) as primary endpoint. Development of elderly specific phase III clinical trials might be challenging, it therefore seems essential to conduct phase II clinical trials evaluating jointly efficacy and toxicity in a well-defined geriatric population. Use of multistage designs that take into account heterogeneity would allow to identify a subpopulation at interim analysis and to reduce the number of patients exposed to an inefficient or a toxic treatment regimen. It is crucial to evaluate new therapies (targeted therapies, immunotherapies) using adequate methodologies (Study design, endpoint).

  3. The Roles of Decision Makers in Special Operations

    DTIC Science & Technology

    2016-12-01

    question and hypotheses. 9 II. CASE STUDIES A. OPERATION THUNDERBOLT (THE RAID ON ENTEBBE) The Israeli Special Forces’ hostage rescue operation...Operations Warfare, 338. 28 Herzog, “The War Against Terrorism: Entebbe,” 338. 29 Chaitanya Arun Sathe, “A Case Study on Crisis Management with a...Assessment of the Roles of Decision Makers This assessment is based on this case study , and the decision makers’ roles in the three phases of a

  4. Effect of education and clinical assessment on the accuracy of post partum blood loss estimation

    PubMed Central

    2014-01-01

    Background This research aimed to assess the effect of health care provider education on the accuracy of post partum blood loss estimation. Methods A non-randomized observational study that was conducted at King Abdulaziz Medical City, Riyadh, Saudi Arabia between January 1, 2011 and June 30, 2011. Hundred and twenty three health care providers who are involved in the estimation of post partum blood loss were eligible to participate. The participants were subjected to three research phases and an educational intervention. They have assessed a total of 30 different simulated blood loss stations, with 10 stations in each of the research phases. These phases took place before and after educational sessions on how to visually estimate blood loss and how to best utilize patient data in clinical scenarios. We have assessed the differences between the estimated blood loss and the actual measure. P-values were calculated to assess the differences between the three research phases estimations. Results The participants significantly under-estimated post partum blood loss. The accuracy was improved after training (p-value < 0.0001) and after analysing each patient’s clinical information (p-value = 0.042). The overall results were not affected by the participants’ clinical backgrounds or their years of experience. Under-estimation was more prominent in cases where more than average-excessive blood losses were simulated while over-estimations or accurate estimations were more prominent in less than average blood loss incidents. Conclusion Simple education programmes can improve traditional findings related to under-estimation of blood loss. More sophisticated clinical education programmes may provide additional improvements. PMID:24646156

  5. Improved imputation accuracy in Hispanic/Latino populations with larger and more diverse reference panels: applications in the Hispanic Community Health Study/Study of Latinos (HCHS/SOL)

    PubMed Central

    Nelson, Sarah C.; Stilp, Adrienne M.; Papanicolaou, George J.; Taylor, Kent D.; Rotter, Jerome I.; Thornton, Timothy A.; Laurie, Cathy C.

    2016-01-01

    Imputation is commonly used in genome-wide association studies to expand the set of genetic variants available for analysis. Larger and more diverse reference panels, such as the final Phase 3 of the 1000 Genomes Project, hold promise for improving imputation accuracy in genetically diverse populations such as Hispanics/Latinos in the USA. Here, we sought to empirically evaluate imputation accuracy when imputing to a 1000 Genomes Phase 3 versus a Phase 1 reference, using participants from the Hispanic Community Health Study/Study of Latinos. Our assessments included calculating the correlation between imputed and observed allelic dosage in a subset of samples genotyped on a supplemental array. We observed that the Phase 3 reference yielded higher accuracy at rare variants, but that the two reference panels were comparable at common variants. At a sample level, the Phase 3 reference improved imputation accuracy in Hispanic/Latino samples from the Caribbean more than for Mainland samples, which we attribute primarily to the additional reference panel samples available in Phase 3. We conclude that a 1000 Genomes Project Phase 3 reference panel can yield improved imputation accuracy compared with Phase 1, particularly for rare variants and for samples of certain genetic ancestry compositions. Our findings can inform imputation design for other genome-wide association studies of participants with diverse ancestries, especially as larger and more diverse reference panels continue to become available. PMID:27346520

  6. Hemodynamic and psychological responses to laboratory stressors in women: Assessing the roles of menstrual cycle phase, premenstrual symptomatology, and sleep characteristics

    PubMed Central

    Lustyk, M. Kathleen B.; Douglas, Haley A.C.; Shilling, Elizabeth A.; Woods, Nancy F.

    2016-01-01

    This study assessed whether premenstrual symptomatology and/or sleep characteristics explain increased luteal phase psychophysiological reactivity to laboratory stressors. We hypothesized that: (1) premenstrual symptoms and sleep characteristics would explain greater luteal versus follicular phase psychophysiological reactivity, (2) symptoms and sleep characteristics would differentially predict psychophysiological reactivity within each cycle phase, and (3) symptoms and sleep characteristics would interact to affect luteal but not follicular reactivity. Freely cycling women (N=87) completed two laboratory sessions, one follicular (cycle days 5–9) and one luteal (days 7–10 post-ovulation). We employed two stressors: one physical (cold pressor task) and the other cognitive in nature (Paced Auditory Serial Addition Task). During testing, electrocardiography monitored heart rate (HR) while a timed and auto-inflatable sphygmomanometer assessed blood pressure (BP). Participants also completed a one-time self-report measure of sleep characteristics and premenstrual symptomatology as well as a measure of state anxiety pre-post stressor. Results revealed greater luteal HR and systolic BP reactivity compared to follicular reactivity (p<0.001 for both analyses), however neither premenstrual symptoms nor sleep characteristics explained this luteal increase. Within cycle analyses revealed that symptoms and sleep characteristics interacted to affect luteal phase state anxiety reactivity (R2=.32, p=.002) with negative affect being associated with more reactivity when sleep hours were low (β=.333, p=.04). Overall, significant relationships existed during the luteal phase only. Findings are discussed in terms of clinical utility and methodological challenges related to performing laboratory stress testing in women. PMID:23092740

  7. Two Phase Detonation Studies Conducted in 1971

    NASA Technical Reports Server (NTRS)

    Nicholls, J. A.

    1972-01-01

    The research covered by this third annual progress report represents a continuation of our efforts devoted to the study of detonation waves in liquid-gas systems. The motivation for the work is associated with liquid propellant rocket motor combustion instability although certainly the studies are also applicable to internal combustion engines, jet propulsion engines, safety aspects of spilled liquid fuel, coal mine explosions, and weaponry. The research has been divided into 5 phases, although all of them are intimately related. For the most part these phases are briefly summarized and the reader is referred to other publications for a more complete treatment. The exception to this is where the material herein represents the only printed information available on the particular facet of the problem. Phase A has been primarily concerned with the breakup and ignition of fuel drops by shock waves. The experimental portion of this study as well as a theoretical treatment of the ignition behavior was completed in the past year. The research is now concentrating on the passage of a shock wave over a burning drop. Phase B has been devoted to the assessment of the approximate energy release pattern in two phase detonations insofar as they affect the significant overpressures observed.

  8. The NASA Lewis Research Center SBIR program: An assessment

    NASA Technical Reports Server (NTRS)

    Grimes, Hubert H.; Metzger, Marie E.; Kim, Walter S.

    1993-01-01

    An assessment was made of the NASA Lewis Small Business Innovation Research (SBIR) Program for the years 1983 to 1989. The assessment was based on the study of 99 Phase 1 contracts and 39 Phase 2 contracts. The overall impact of SBIR was found to be very positive, contributing strongly to many NASA programs. In addition, many successful efforts were commercialized benefiting the small business, federal agencies, and the aerospace industry. The program was evaluated in terms of contract quality, innovativeness, comparison to the state-of-the-art, achievement of goals, difficulty, and impact. Program difficulties were also identified, which could suggest possible program improvements. Much of the information gained in this assessment provided a basis for a SBIR data base which will be updated every year. This data base is computerized and will provide an excellent source of information about past SBIR efforts and company capabilities.

  9. Activity and safety of AZD3759 in EGFR-mutant non-small-cell lung cancer with CNS metastases (BLOOM): a phase 1, open-label, dose-escalation and dose-expansion study.

    PubMed

    Ahn, Myung-Ju; Kim, Dong-Wan; Cho, Byoung Chul; Kim, Sang-We; Lee, Jong Seok; Ahn, Jin-Seok; Kim, Tae Min; Lin, Chia-Chi; Kim, Hye Ryun; John, Thomas; Kao, Steven; Goldman, Jonathan W; Su, Wu-Chou; Natale, Ronald; Rabbie, Sarit; Harrop, Bryony; Overend, Philip; Yang, Zhenfan; Yang, James Chih-Hsin

    2017-11-01

    CNS metastases-including brain and leptomeningeal metastases-from epidermal growth factor receptor (EGFR)-mutant non-small-cell lung cancer (NSCLC) are associated with poor prognosis. AZD3759 is a novel EGFR tyrosine kinase inhibitor with high capability to penetrate the blood-brain barrier. We aimed to assess the safety, tolerability, pharmacokinetics, and efficacy of AZD3759 in patients with EGFR-mutant NSCLC with brain and leptomeningeal metastases. This open-label, multicentre, phase 1 study was undertaken at 11 centres and hospitals in Australia, South Korea, Taiwan, and the USA. Eligible patients included those with histologically confirmed, advanced-stage, EGFR-mutant NSCLC. The study was done in two parts, with dose-escalation and dose-expansion phases. In the dose-escalation phase, patients who had progressed after treatment with an EGFR tyrosine kinase inhibitor received AZD3759 at 50 mg, 100 mg, 200 mg, 300 mg, or 500 mg twice a day. In the dose-expansion phase, AZD3759 at 200 mg or 300 mg twice a day was administered to patients with either brain or leptomeningeal metastases who had never received an EGFR tyrosine kinase inhibitor and patients with leptomeningeal metastases who had been pretreated with an EGFR tyrosine kinase inhibitor. The primary objective was safety and tolerability, with severity of adverse events assessed with the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.03. This trial is registered with ClinicalTrials.gov, number NCT02228369. Between Nov 18, 2014, and Sept 7, 2016, 67 patients with NSCLC were enrolled into the study, 29 to the dose-escalation phase and 38 to the dose-expansion phase. At data cutoff (Dec 12, 2016), three (10%) patients in the dose-escalation phase and 20 (53%) in the dose-expansion phase were still receiving treatment. Dose-limiting toxic effects occurred in two (67%) of three patients who received 500 mg twice a day in the dose-escalation phase (grade 3 acne [n=1] and intolerable grade 2 mucosal inflammation [n=1]); hence, doses of 200 mg and 300 mg twice a day were selected for further assessment in the dose-expansion phase. Drug-related skin and gastrointestinal disorders of any grade occurred in 35 (92%) and 29 (76%) patients in the dose-expansion phase, respectively, and led to treatment discontinuation in one (4%) patient treated with 200 mg twice a day (grade 3 increase of alanine aminotransferase and aspartate aminotransferase) and two (13%) patients given 300 mg twice a day (grade 3 diarrhoea [n=1] and grade 3 skin rash [n=1]). Grade 3 skin and gastrointestinal disorders occurred in four (17%) and two (9%) patients, respectively, at a dose of 200 mg twice a day, and in six (40%) and four (27%) patients, respectively, at a dose of 300 mg twice a day. No grade 4 disorders arose. Other grade 3 disorders included hepatobiliary and renal disorders (three [13%] at 200 mg twice a day), asthenia (one [7%] at 300 mg twice a day), infections and infestations (one [7%] at 300 mg twice a day), and metabolism and nutrition disorders (one [4%] at 200 mg twice a day and one [7%] at 300 mg twice a day). AZD3759 at a dose of 200 mg twice daily showed a tolerable safety profile in patients with NSCLC and CNS metastases who had either never received a tyrosine kinase inhibitor or who had been pretreated with a tyrosine kinase inhibitor. The good penetration of the blood-brain barrier by AZD3759, and its promising clinical activity, support further assessment of this compound in studies. AstraZeneca. Copyright © 2017 Elsevier Ltd. All rights reserved.

  10. Using a visual plate waste study to monitor menu performance.

    PubMed

    Connors, Priscilla L; Rozell, Sarah B

    2004-01-01

    Two visual plate waste studies were conducted in 1-week phases over a 1-year period in an acute care hospital. A total of 383 trays were evaluated in the first phase and 467 in the second. Food items were ranked for consumption from a low (1) to high (6) score, with a score of 4.0 set as the benchmark denoting a minimum level of acceptable consumption. In the first phase two entrees, four starches, all of the vegetables, sliced white bread, and skim milk scored below the benchmark. As a result six menu items were replaced and one was modified. In the second phase all entrees scored at or above 4.0, as did seven vegetables, and a dinner roll that replaced sliced white bread. Skim milk continued to score below the benchmark. A visual plate waste study assists in benchmarking performance, planning menu changes, and assessing effectiveness.

  11. A Chinese translation of the EdFED-Q and assessment of equivalence.

    PubMed

    Lin, Li-Chan; Chang, Chia-Chi

    2003-01-01

    The purpose of this study was to translate the Edinburgh Feeding Evaluation in Dementia Questionnaire (EdFED-Q) from the original English into a Chinese language version and to assess the equivalence of the English and Chinese EdFED-Q versions. To use a directly translated instrument without minimal explanation of the procedures for determining the equivalence between the original and secondary language instrument is questionable. Ensuring equivalence of a translated Chinese version of the EdFED-Q for patients with dementia is an essential prerequisite for identifying culturally specific expressions of feeding difficulty under investigation. Phase 1 consisted of experts doing the initial translation into Chinese and then English back-translations of the questionnaire. Six experts determined the equality of the Chinese and English versions, and five monolingual nurses provided information for the C-EdFED-Q. In phase 2, two bilingual gerontological nurses rated 33 residents with dementia to determine equivalence across time. In phase 3, three groups of bilingual nurses used the Chinese, English, and finally both versions simultaneously to judge a model case's feeding behavior on the videotape. In phase 1, the rating on the equality of the items on the Chinese and English versions was 0.969. In phase 2, kappa coefficients for all items on the C-EdFED-Q and E-EdFED-Q ranged from 0.44 to 1.00. In determining the consistency of the scores for the C-EdFED-Q and E-EdFED-Q between the two raters across time, the intraclass correlation coefficient for the absolute agreement was found to range from 0.85 to 0.90. In phase 3, except for items 6 and 9, all items showed no significant difference among the three groups. Further studies to assess the relationship between constructs and to compare it with known and predicted relationships are recommended.

  12. Bovine rotavirus pentavalent vaccine development in India.

    PubMed

    Zade, Jagdish K; Kulkarni, Prasad S; Desai, Sajjad A; Sabale, Rajendra N; Naik, Sameer P; Dhere, Rajeev M

    2014-08-11

    A bovine rotavirus pentavalent vaccine (BRV-PV) containing rotavirus human-bovine (UK) reassortant strains of serotype G1, G2, G3, G4 and G9 has been developed by the Serum Institute of India Ltd, in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), USA. The vaccine underwent animal toxicity studies and Phase I and II studies in adults, toddlers and infants. It has been found safe and immunogenic and will undergo a large Phase III study to assess efficacy against severe rotavirus gastroenteritis. Copyright © 2014. Published by Elsevier Ltd.

  13. Development and evaluation of a thermochemistry concept inventory for college-level general chemistry

    NASA Astrophysics Data System (ADS)

    Wren, David A.

    The research presented in this dissertation culminated in a 10-item Thermochemistry Concept Inventory (TCI). The development of the TCI can be divided into two main phases: qualitative studies and quantitative studies. Both phases focused on the primary stakeholders of the TCI, college-level general chemistry instructors and students. Each phase was designed to collect evidence for the validity of the interpretations and uses of TCI testing data. A central use of TCI testing data is to identify student conceptual misunderstandings, which are represented as incorrect options of multiple-choice TCI items. Therefore, quantitative and qualitative studies focused heavily on collecting evidence at the item-level, where important interpretations may be made by TCI users. Qualitative studies included student interviews (N = 28) and online expert surveys (N = 30). Think-aloud student interviews (N = 12) were used to identify conceptual misunderstandings used by students. Novice response process validity interviews (N = 16) helped provide information on how students interpreted and answered TCI items and were the basis of item revisions. Practicing general chemistry instructors (N = 18), or experts, defined boundaries of thermochemistry content included on the TCI. Once TCI items were in the later stages of development, an online version of the TCI was used in expert response process validity survey (N = 12), to provide expert feedback on item content, format and consensus of the correct answer for each item. Quantitative studies included three phases: beta testing of TCI items (N = 280), pilot testing of the a 12-item TCI (N = 485), and a large data collection using a 10-item TCI ( N = 1331). In addition to traditional classical test theory analysis, Rasch model analysis was also used for evaluation of testing data at the test and item level. The TCI was administered in both formative assessment (beta and pilot testing) and summative assessment (large data collection), with items performing well in both. One item, item K, did not have acceptable psychometric properties when the TCI was used as a quiz (summative assessment), but was retained in the final version of the TCI based on the acceptable psychometric properties displayed in pilot testing (formative assessment).

  14. Evaluating a community-based exercise intervention with adults living with HIV: protocol for an interrupted time series study

    PubMed Central

    O'Brien, Kelly K; Bayoumi, Ahmed M; Solomon, Patricia; Tang, Ada; Murzin, Kate; Chan Carusone, Soo; Zobeiry, Mehdi; Nayar, Ayesha; Davis, Aileen M

    2016-01-01

    Introduction Our aim was to evaluate a community-based exercise (CBE) intervention with the goal of reducing disability and enhancing health for community-dwelling people living with HIV (PLWH). Methods and analysis We will use a mixed-methods implementation science study design, including a prospective longitudinal interrupted time series study, to evaluate a CBE intervention with PLWH in Toronto, Canada. We will recruit PLWH who consider themselves medically stable and safe to participate in exercise. In the baseline phase (0–8 months), participants will be monitored bimonthly. In the intervention phase (8–14 months), participants will take part in a 24-week CBE intervention that includes aerobic, resistance, balance and flexibility exercise at the YMCA 3 times per week, with weekly supervision by a fitness instructor, and monthly educational sessions. In the follow-up phase (14–22 months), participants will be encouraged to continue to engage in unsupervised exercise 3 times per week. Quantitative assessment: We will assess cardiopulmonary fitness, strength, weight, body composition and flexibility outcomes followed by the administration of self-reported questionnaires to assess disability and contextual factor outcomes (coping, mastery, stigma, social support) bimonthly. We will use time series regression analysis to determine the level and trend of outcomes across each phase in relation to the intervention. Qualitative assessment: We will conduct a series of face-to-face interviews with a subsample of participants and recreation providers at initiation, midpoint and completion of the 24-week CBE intervention. We will explore experiences and anticipated benefits with exercise, perceived impact of CBE for PLWH and the strengths and challenges of implementing a CBE intervention. Interviews will be audio recorded and analysed thematically. Ethics and dissemination Protocol approved by the University of Toronto HIV/AIDS Research Ethics Board. Knowledge translation will occur with stakeholders in the form of presentations and publications in open access peer-reviewed journals. Trial registration number NCT02794415; Pre-results. PMID:27798038

  15. Understanding Resident Performance, Mindfulness, and Communication in Critical Care Rotations.

    PubMed

    Real, Kevin; Fields-Elswick, Katelyn; Bernard, Andrew C

    Evidence from the medical literature suggests that surgical trainees can benefit from mindful practices. Surgical educators are challenged with the need to address resident core competencies, some of which may be facilitated by higher levels of mindfulness. This study explores whether mindful residents perform better than their peers as members of the health care team. This study employed a multiphase, multimethod design to assess resident mindfulness, communication, and clinical performance. Academic, tertiary medical center. Residents (N = 51) working in an intensive care unit. In phase I, medical residents completed a self-report survey of mindfulness, communication, emotional affect, and clinical decision-making. In phase II, resident performance was assessed using independent ratings of mindfulness and clinical decision-making by attending physicians and registered nurses. In phase 1, a significant positive relationship was found between resident performance and mindfulness, positive affect (PA), and communication. In phase 2, attending physicians/registered nurses' perceptions of residents' mindfulness were positively correlated with communication and inversely related to negative affect (NA). The top quartile of residents for performance and mindfulness had the lowest NA. Higher-rated residents underestimated their performance/mindfulness, whereas those in the lowest quartile overestimated these factors. This study offers a number of implications for medical resident education. First, mindfulness was perceived to be a significant contributor to self-assessments of competency and performance. Second, both PA and NA were important to mindfulness and performance. Third, communication was associated with resident performance, mindfulness, and PA. These implications suggest that individual characteristics of mindfulness, communication, and affect, all potentially modifiable, influence care quality and safety. To improve low performers, surgical educators could screen and identify residents with inaccurate self-assessments. Residents open to feedback will improve faster and develop awareness toward situations and interactions with patients, colleagues, attending physicians, and staff. Copyright © 2017 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

  16. Quantifying statistical relationships between commonly used in vitro models for estimating lead bioaccessibility.

    PubMed

    Yan, Kaihong; Dong, Zhaomin; Liu, Yanju; Naidu, Ravi

    2016-04-01

    Bioaccessibility to assess potential risks resulting from exposure to Pb-contaminated soils is commonly estimated using various in vitro methods. However, existing in vitro methods yield different results depending on the composition of the extractant as well as the contaminated soils. For this reason, the relationships between the five commonly used in vitro methods, the Relative Bioavailability Leaching Procedure (RBALP), the unified BioAccessibility Research Group Europe (BARGE) method (UBM), the Solubility Bioaccessibility Research Consortium assay (SBRC), a Physiologically Based Extraction Test (PBET), and the in vitro Digestion Model (RIVM) were quantified statistically using 10 soils from long-term Pb-contaminated mining and smelter sites located in Western Australia and South Australia. For all 10 soils, the measured Pb bioaccessibility regarding all in vitro methods varied from 1.9 to 106% for gastric phase, which is higher than that for intestinal phase: 0.2 ∼ 78.6%. The variations in Pb bioaccessibility depend on the in vitro models being used, suggesting that the method chosen for bioaccessibility assessment must be validated against in vivo studies prior to use for predicting risk. Regression studies between RBALP and SRBC, RBALP and RIVM (0.06) (0.06 g of soil in each tube, S:L ratios for gastric phase and intestinal phase are 1:375 and 1:958, respectively) showed that Pb bioaccessibility based on the three methods were comparable. Meanwhile, the slopes between RBALP and UBM, RBALP and RIVM (0.6) (0.6 g soil in each tube, S:L ratios for gastric phase and intestinal phase are 1:37.5 and 1:96, respectively) were 1.21 and 1.02, respectively. The findings presented in this study could help standardize in vitro bioaccessibility measurements and provide a scientific basis for further relating Pb bioavailability and soil properties.

  17. Phase I/II Trial and Pharmacokinetic Study of Cixutumumab in Pediatric Patients With Refractory Solid Tumors and Ewing Sarcoma: A Report From the Children's Oncology Group

    PubMed Central

    Malempati, Suman; Weigel, Brenda; Ingle, Ashish M.; Ahern, Charlotte H.; Carroll, Julie M.; Roberts, Charles T.; Reid, Joel M.; Schmechel, Stephen; Voss, Stephan D.; Cho, Steven Y.; Chen, Helen X.; Krailo, Mark D.; Adamson, Peter C.; Blaney, Susan M.

    2012-01-01

    Purpose A phase I/II study of cixutumumab (IMC-A12) in children with refractory solid tumors was conducted. This study was designed to assess the toxicities, pharmacokinetics, and pharmacodynamics of cixutumumab in children to determine a recommended phase II dose and to assess antitumor activity in Ewing sarcoma (ES). Patients and Methods Pediatric patients with relapsed or refractory solid tumors were treated with cixutumumab as a 1-hour intravenous infusion once per week. Two dose levels—6 and 9 mg/kg—were evaluated using a standard three-plus-three cohort design. Patients with refractory ES were treated in an expanded phase II cohort at each dose level. Results Forty-seven eligible patients with a median age of 15 years (range, 4 to 28 years) were enrolled. Twelve patients were treated in the dose-finding phase. Hematologic and nonhematologic toxicities were generally mild and infrequent. Dose-limiting toxicities included grade 4 thrombocytopenia at 6 mg/kg and grade 3 dehydration at 9 mg/kg. Mean trough concentration (± standard deviation) at 9 mg/kg was 106 ± 57 μg/mL, which exceeded the effective trough concentration of 60 μg/mL observed in xenograft models. Three patients with ES had confirmed partial responses: one of 10 at 6 mg/kg and two of 20 at 9 mg/kg. Serum insulin-like growth factor I (IGF-I) levels consistently increased after one dose of cixutumumab. Tumor IGF-I receptor expression by immunohistochemistry did not correlate with response in patients with ES. Conclusion Cixutumumab is well tolerated in children with refractory solid tumors. The recommended phase II dose is 9 mg/kg. Limited single-agent activity of cixutumumab was seen in ES. PMID:22184397

  18. Translation and psychometric assessment of the Persian version of the Rhodes Index of Nausea, Vomiting and Retching (INVR) scale for the assessment of chemotherapy-induced nausea and vomiting.

    PubMed

    Moradian, S; Shahidsales, S; Ghavam Nasiri, M R; Pilling, M; Molassiotis, A; Walshe, C

    2014-11-01

    No tools are available to assess or measure the experience of chemotherapy-induced nausea and vomiting (CINV) for Persian/Farsi speakers. The purpose of this study is to translate the Rhodes Index of Nausea, Vomiting and Retching (INVR) scale for use with Persian-speaking cancer patients. A sample of 94 cancer patients were recruited from a cancer research centre in Mashhad-Iran. A standard two phase process of scale translation and validation was conducted. In phase I, standard 'forward-backward' translation procedure was used to translate the original version of the INVR questionnaire into Persian. The translated questionnaire was reviewed and revised and a Persian version of the scale was produced. In the second phase, a multiphase instrumentation study describing the internal consistency and test-retest reliability of the translated version was conducted. The inter-item correlation measured by Cronbach's alpha was 0.88. Test/re-test reliability was measured by the weighted kappa and was between 0.63 and 0.79, indicating 'substantial agreement' and stability between the initial and subsequent administrations for each item. These results demonstrate that the Persian version of the INVR is acceptable for use among Iranian cancer patients. Researchers could use this study as a model for future translation and application of psychometric instrumentation. © 2013 John Wiley & Sons Ltd.

  19. Characterization and Computational Modeling of Minor Phases in Alloy LSHR

    NASA Technical Reports Server (NTRS)

    Jou, Herng-Jeng; Olson, Gregory; Gabb, Timothy; Garg, Anita; Miller, Derek

    2012-01-01

    The minor phases of powder metallurgy disk superalloy LSHR were studied. Samples were consistently heat treated at three different temperatures for long times to approach equilibrium. Additional heat treatments were also performed for shorter times, to assess minor phase kinetics in non-equilibrium conditions. Minor phases including MC carbides, M23C6 carbides, M3B2 borides, and sigma were identified. Their average sizes and total area fractions were determined. CALPHAD thermodynamics databases and PrecipiCalc(TradeMark), a computational precipitation modeling tool, were employed with Ni-base thermodynamics and diffusion databases to model and simulate the phase microstructural evolution observed in the experiments with an objective to identify the model limitations and the directions of model enhancement.

  20. IMPLEMENTATION OF DEFENSE NUCLEAR FACILITY SAFETY BOARD RECOMMENDATION 2000-2 AT WIPP

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

    Jackson, K.; Wu, C.

    2002-02-26

    The Defense Nuclear Safeties Board (DNFSB) issued Recommendation 2000-2 on March 8, 2000, concerning the degrading conditions of vital safety systems, or systems important to nuclear safety, at DOE sites across the nation. The Board recommended that the DOE take action to assess the condition of its nuclear systems to ensure continued operational readiness of vital safety systems that are important for safely accomplishing the DOE's mission. To verify the readiness of vital safety systems, a two-phased approach was established. Phase I consisted of a qualitative assessment to approved criteria of the defined vital safety systems by operating contractor personnel,more » overseen by Federal field office personnel. Based on Phase I Assessment results, vital safety systems with significant deficiencies would be further assessed in Phase II, a more extensive quantitative assessment, by a contractor and Federal team, using a second set of criteria. In addition, Defense Nuclear Facility Safety Board Recommendation 2000-2 concluded that the degradation of confinement ventilation systems was of major concern, and issued a separate set of criteria to perform a Phase II Assessment on confinement ventilation systems.« less

  1. Using a Multidisciplinary Training Program to Reduce Peritonitis in Peritoneal Dialysis Patients

    PubMed Central

    Gadola, Liliana; Poggi, Carla; Poggio, María; Sáez, Lucía; Ferrari, Alejandra; Romero, Jorge; Fumero, Soledad; Ghelfi, Gianella; Chifflet, Liliana; Borges, Patricia Larre

    2013-01-01

    ♦ Objectives: The present study evaluated the tool used to assess patients’ skills and the impact on peritonitis rates of a new multidisciplinary peritoneal dialysis (PD) education program (PDEP). ♦ Methods: After the University Hospital Ethics Committee approved the study, the educational and clinical records of PD patients were retrospectively analyzed in two phases. In phase I, an Objective Structured Assessment (OSA) was used during August 2008 to evaluate the practical skills of 25 patients with adequate Kt/V and no mental disabilities who had been on PD for more than 1 month. Test results were correlated with the prior year’s peritonitis rate. In phase II, the new PDEP, consisting of individual lessons, a retraining schedule, and group meetings, was introduced starting 1 September 2008. Age, sex, years of education, time on PD, number of training sessions, and peritonitis episodes were recorded. Statistical analyses used t-tests, chi-square tests, and Poisson distributions; a p value of less than 0.05 was considered significant. ♦ Results: In phase I, 25 patients [16 men, 9 women; mean age: 54 ± 15 years (range: 22 - 84 years); mean time on PD: 35 ± 30 months (range: 1 - 107 months)] were studied. The OSA results correlated with peritonitis rates: patients who passed the test had experienced significantly lower peritonitis rates during the prior year (p < 0.05). In phase II, after the new PDEP was introduced, overall peritonitis rates significantly declined (to 0.28 episodes/patient-year from 0.55 episodes/patient-year, p < 0.05); the Staphylococcus peritonitis rate also declined (to 0.09 episodes/patient-year from 0.24 episodes/patient-year, p < 0.05). ♦ Conclusions: The OSA is a reliable tool for assessing patients’ skills, and it correlates with peritonitis rates. The multidisciplinary PDEP significantly improved outcomes by further lowering peritonitis rates. PMID:22753455

  2. Shift Work and Cognitive Flexibility: Decomposing Task Performance.

    PubMed

    Cheng, Philip; Tallent, Gabriel; Bender, Thomas John; Tran, Kieulinh Michelle; Drake, Christopher L

    2017-04-01

    Deficits in cognitive functioning associated with shift work are particularly relevant to occupational performance; however, few studies have examined how cognitive functioning is associated with specific components of shift work. This observational study examined how circadian phase, nocturnal sleepiness, and daytime insomnia in a sample of shift workers ( N = 30) were associated with cognitive flexibility during the night shift. Cognitive flexibility was measured using a computerized task-switching paradigm, which produces 2 indexes of flexibility: switch cost and set inhibition. Switch cost represents the additional cognitive effort required in switching to a different task and can impact performance when multitasking is involved. Set inhibition is the efficiency in returning to previously completed tasks and represents the degree of cognitive perseveration, which can lead to reduced accuracy. Circadian phase was measured via melatonin assays, nocturnal sleepiness was assessed using the Multiple Sleep Latency Test, and daytime insomnia was assessed using the Insomnia Severity Index. Results indicated that those with an earlier circadian phase, insomnia, and sleepiness exhibited reduced cognitive flexibility; however, specific components of cognitive flexibility were differentially associated with circadian phase, insomnia, and sleepiness. Individuals with an earlier circadian phase (thus more misaligned to the night shift) exhibited larger switch costs, which was also associated with reduced task efficiency. Shift workers with more daytime insomnia demonstrated difficulties with cognitive inhibition, whereas nocturnal sleepiness was associated with difficulties in reactivating previous tasks. Deficits in set inhibition were also related to reduced accuracy and increased perseverative errors. Together, this study indicates that task performance deficits in shift work are complex and are variably impacted by different mechanisms. Future research may examine phenotypic differences in shift work and the associated consequences. Results also suggest that fatigue risk management strategies may benefit from increased scope and specificity in assessment of sleep, sleepiness, and circadian rhythms in shift workers.

  3. Meta-analyses and adaptive group sequential designs in the clinical development process.

    PubMed

    Jennison, Christopher; Turnbull, Bruce W

    2005-01-01

    The clinical development process can be viewed as a succession of trials, possibly overlapping in calendar time. The design of each trial may be influenced by results from previous studies and other currently proceeding trials, as well as by external information. Results from all of these trials must be considered together in order to assess the efficacy and safety of the proposed new treatment. Meta-analysis techniques provide a formal way of combining the information. We examine how such methods can be used in combining results from: (1) a collection of separate studies, (2) a sequence of studies in an organized development program, and (3) stages within a single study using a (possibly adaptive) group sequential design. We present two examples. The first example concerns the combining of results from a Phase IIb trial using several dose levels or treatment arms with those of the Phase III trial comparing the treatment selected in Phase IIb against a control This enables a "seamless transition" from Phase IIb to Phase III. The second example examines the use of combination tests to analyze data from an adaptive group sequential trial.

  4. Microbiological Tests Performed During the Design of the International Space Station ECLSS: Part 1, Bulk Phase Water and Wastewater

    NASA Technical Reports Server (NTRS)

    Roman, Monsi C.; Mittelman, Marc W.

    2010-01-01

    This slide presentation summarizes the studies performed to assess the bulk phase microbial community during the Space Station Water Recover Tests (WRT) from 1990-1998. These tests show that it is possible to recycle water from different sources including urine, and produce water that can exceed the quality of municpally produced tap water.

  5. Open Scenario Study, Phase I. Volume 1. Assessment Overview and Results

    DTIC Science & Technology

    2008-03-01

    review of resources and requirements necessary to implement the response and improving civil military relations. Money Laudering Presents local...or money ? C. PHASE ONE APPROACH To systematically address these kinds of questions, IDA pursued a three-part approach that included reviewing the...their organizations a significant amount of time or money ? B. INTERVIEW QUESTIONS The final sponsor-approved version of the interview questions

  6. High level waste storage tanks 242-A evaporator S/RID phase II assessment report

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

    Biebesheimer, E.

    This document, the Standards/Requirements Identification Document (S/RID) Phase 2 Assessment Report for the subject facility, represents the results of a Performance Assessment to determine whether procedures containing S/RID requirements are fully implemented by field personnel in the field. It contains a summary report and three attachments; an assessment schedule, performance objectives, and assessments for selected functional areas.

  7. Acceptance of internet-based hearing healthcare among adults who fail a hearing screening.

    PubMed

    Rothpletz, Ann M; Moore, Ashley N; Preminger, Jill E

    2016-09-01

    This study measured help-seeking readiness and acceptance of existing internet-based hearing healthcare (IHHC) websites among a group of older adults who failed a hearing screening (Phase 1). It also explored the effects of brief training on participants' acceptance of IHHC (Phase 2). Twenty-seven adults (age 55+) who failed a hearing screening participated. During Phase 1 participants were administered the University of Rhode Island Change Assessment (URICA) and patient technology acceptance model (PTAM) Questionnaire. During Phase 2 participants were randomly assigned to a training or control group. Training group participants attended an instructional class on existing IHHC websites. The control group received no training. The PTAM questionnaire was re-administered to both groups 4-6 weeks following the initial assessment. The majority of participants were either considering or preparing to do something about their hearing loss, and were generally accepting of IHHC websites (Phase 1). The participants who underwent brief IHHC training reported increases in hearing healthcare knowledge and slight improvements in computer self-efficacy (Phase 2). Older adults who fail hearing screenings may be good candidates for IHHC. The incorporation of a simple user-interface and short-term training may optimize the usability of future IHHC programs for this population.

  8. Implementing team huddles in small rural hospitals: How does the Kotter model of change apply?

    PubMed

    Baloh, Jure; Zhu, Xi; Ward, Marcia M

    2017-12-17

    To examine how the process of change prescribed in Kotter's change model applies in implementing team huddles, and to assess the impact of the execution of early change phases on change success in later phases. Kotter's model can help to guide hospital leaders to implement change and potentially to improve success rates. However, the model is under studied, particularly in health care. We followed eight hospitals implementing team huddles for 2 years, interviewing the change teams quarterly to inquire about implementation progress. We assessed how the hospitals performed in the three overarching phases of the Kotter model, and examined whether performance in the initial phase influenced subsequent performance. In half of the hospitals, change processes were congruent with Kotter's model, where performance in the initial phase influenced their success in subsequent phases. In other hospitals, change processes were incongruent with the model, and their success depended on implementation scope and the strategies employed. We found mixed support for the Kotter model. It better fits implementation that aims to spread to multiple hospital units. When the scope is limited, changes can be successful even when steps are skipped. Kotter's model can be a useful guide for nurse managers implementing changes. © 2017 John Wiley & Sons Ltd.

  9. Omega-3 fatty acid treatment of children with attention-deficit hyperactivity disorder: A randomized, double-blind, placebo-controlled study

    PubMed Central

    Bélanger, Stacey Ageranioti; Vanasse, Michel; Spahis, Schohraya; Sylvestre, Marie-Pierre; Lippé, Sarah; l’Heureux, François; Ghadirian, Parviz; Vanasse, Catherine-Marie; Levy, Emile

    2009-01-01

    BACKGROUND: Although several clinical trials have evaluated the impact of n-3 polyunsaturated fatty acid (PUFA) on patients with attention-deficit hyperactivity disorder (ADHD), changes in plasma PUFA composition were not always assessed following n-3 supplementation. Furthermore, no reports are available on the efficacy of n-3 PUFA in Canadian youth with ADHD. OBJECTIVES: To determine fatty acid (FA) composition, and the efficacy and safety of n-3 PUFA supplementation on ADHD clinical symptoms in French Canadian primary school children. PATIENTS AND METHODS: The Strengths and Weaknesses in ADHD and Normal Behaviors (SWAN) and Conners’ questionnaires were used to assess changes in ADHD symptoms in 37 children (only 26 children completed the study from zero to 16 weeks). They were divided into two groups (A and B), and participated in a 16-week, double-blind, one-way, crossover randomized study. In the first phase, group A received the n-3 PUFA supplement and group B received n-6 PUFA (sunflower oil) as a placebo. During the second phase, group B received the active n-3 PUFA supplement that was continued in group A. FA composition and lipid profile were assessed during the phases of the study. RESULTS: FA differences between groups were observed in the 26 patients. Supplementation with n-3 PUFA resulted in significant increases in eicosapentaenoic and docosahexaenoic acids in group A, while group B was enriched with alpha-linolenic, gamma-linolenic and homo-gamma-linolenic acids. The n-3 PUFA supplement was tolerated without any adverse effects. A statistically significant improvement in symptoms was noted based on the parent version of the Conners’ questionnaire from baseline to the end of phase 1, and this amelioration continued from phases 1 to 2, although the latter changes from phases 1 and 2 were not statistically significant in any of the subscales except for the subscale measuring inattention in group B. The improvement was greater in patients from group A in phase 1 and in patients from group B in phase 2. A subgroup of eight patients (four in each group) displayed a statistically significant clinical improvement following the administration of the n-3 PUFA supplement, particularly for the inattention and global Diagnostic and Statistical Manual of Mental Disorders, Fourth edition, total Conners’ subscales. CONCLUSIONS: A subgroup of children with ADHD who used n-3 PUFA supplements achieved and maintained symptom control. The data of the present study also supported n-3 PUFA safety and tolerability, but limited changes were noted in the FA profile in French Canadians with ADHD. PMID:19436468

  10. Vietnamese Amerasians: Practical Implications of Current Research.

    ERIC Educational Resources Information Center

    Felsman, J. Kirk.; And Others

    This study was conducted to examine the experiences of Amerasians from Vietnam who resettled in the United States and to explore coping and adaptation among Vietnamese Amerasians over time. The initial data collection phase involved in-camp assessment of a randomly selected sample of Amerasian adolescents (N=259). The assessment is to be repeated…

  11. Scaffolding Young Children: The Utility of Mediation in a Classification Test

    ERIC Educational Resources Information Center

    Mata, Sara; van Geert, Paul; van der Aalsvoort, Geerdina

    2017-01-01

    Introduction: Studies of Dynamic Assessment of cognitive abilities reveal that young children profit from assistance while carrying out tasks that elicit cognitive effort. Dynamic assessment refers to a test format of a pretest-mediation-posttest in which the mediation phase includes scaffolding to assist the child to grasp the purpose of the…

  12. NATIONAL HUMAN EXPOSURE ASSESSMENT SURVEY (NHEXAS): ANALYSIS OF EXPOSURE PATHWAYS AND ROUTES FOR ARSENIC AND LEAD IN EPA REGION 5

    EPA Science Inventory

    The National Human Exposure Assessment Survey (NHEXAS) Phase I field study conducted in EPA Region 5 (Great Lakes Area) provides extensive exposure data on a representative sample of approximately 250 residents of the region. Associated environmental media and biomarker (blood...

  13. Detection of Intimate Partner Violence in a General Medicine Practice

    ERIC Educational Resources Information Center

    Soglin, Lenore F.; Bauchat, Jeanette; Soglin, David F.; Martin, Gary J.

    2009-01-01

    In this study, an assessment phase is undertaken to determine intimate partner violence (IPV) prevalence. An anonymous survey is followed by a chart review documenting identification of IPV. Two methods are attempted to increase assessment/documentation of IPV: a physician educational intervention and a nursing routine inquiry intervention in one…

  14. Efficacy of treatment with ranibizumab in patients with wet age-related macular degeneration in routine clinical care: data from the COMPASS health services research.

    PubMed

    Wolf, Armin; Kampik, Anselm

    2014-04-01

    To assess healthcare processes during treatment of neovascular age-related macular degeneration (AMD) in patients under real-life conditions and evaluate efficacy of monthly visual acuity (VA) assessment in a pro re nata treatment regime. A multicentre, prospective, non-interventional study based in Germany included neovascular AMD patients treated with intravitreal ranibizumab. Patients completed a 3-month loading phase with monthly intravitreal injections of 0.5 mg ranibizumab, followed by a 12-month maintenance phase during which investigators documented VA, additional injections, metamorphopsias, routine ophthalmological examinations and adverse events at monthly follow-up visits. Efficacy analysis included change from baseline in best-corrected VA (BCVA) based on descriptive statistics. A total of 2,232 patients were enrolled throughout Germany and 1,729 patients (mean age 77.8 years, 63.2 % women) comprised the efficacy population with a complete set of data. In the clinical setting recorded in our study, only a minority of patients underwent optical coherence tomography during the maintenance phase (71 of 1,729 patients). Patients received a mean total of 4.5 injections; three injections during upload phase and 1.5 additional injections during maintenance phase. Over half of the patients (51.4 %) did not receive additional injections. Mean decimal BCVA increased during the upload phase, (from LogMAR mean of 0.201 at baseline to 0.219 at Month 4) but displayed a decline over time (0.192 at Month 15). Ranibizumab treatment in a real-life setting demonstrated efficacy in neovascular AMD patients, as shown by initial gains in BCVA. However, maintenance and improvement of these gains during the maintenance phase in a clinical routine setting remained below those expected compared with MARINA, ANCHOR and CATT trials, most likely due to a low number of retreatments, and the high number of patients with a poor response in regard to improvements of VA who were not investigated in these studies. This phase IV non-interventional health services research study was conducted under the Novartis internal registration code, CRFB002ADE10.

  15. Differential Response Pattern of Oropharyngeal Pressure by Bolus and Dry Swallows.

    PubMed

    Hasegawa, Mana; Kurose, Masayuki; Okamoto, Keiichiro; Yamada, Yoshiaki; Tsujimura, Takanori; Inoue, Makoto; Sato, Taisuke; Narumi, Takatsune; Fujii, Noritaka; Yamamura, Kensuke

    2018-02-01

    The aim of this study was to determine if bolus and dry swallow showed similar pressure changes in the oropharynx using our newly developed device. A unique character of it includes that baropressure can be measured with the sensor being placed in the balloon and can assess the swallowing mechanics in terms of pressure changes in the oropharynx with less influences of direct contacts of boluses and oropharyngeal structures during swallow indirectly. Fifteen healthy subjects swallowed saliva (dry), 15 ml of water, 45 ml of water, and 15 ml of two different types of food in terms of viscosity (potage soup-type and mayonnaise-type foods). Suprahyoid muscle activity was recorded simultaneously. Three parameters, area under the curve (AUC), peak amplitude, and duration of pressure, were analyzed from each swallow. Almost all of the bolus swallowing events had biphasic baropressure responses consisting of an early phase and late phase (99%), whereas 90% of the saliva swallowing events had a single phase. AUC, peak, and duration displayed greater effects during the late phase than during the early phase. Baropressure of the early phase, but not of the late phase, significantly increased with increasing volume; however, small but significant viscosity effects on pressure were seen during both phases. Peak pressure of the late phase was preceded by maximum muscle activity, whereas that of the early phase was seen when muscle activity displayed a peak response. These findings indicated that our device with the ability to measure baropressure has the potential to provide additional parameter to assess the swallow physiology, and biphasic baropressure responses in the early and late phases could reflect functional aspects of the swallowing reflexes.

  16. Training Graduate and Undergraduate Students in Simulation and Risk Assessment for Carbon Sequestration

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

    McCray, John

    Capturing carbon dioxide (CO2) and injecting it into deep underground formations for storage (carbon capture and underground storage, or CCUS) is one way of reducing anthropogenic CO2 emissions. Gas or aqueous-phase leakage may occur due to transport via faults and fractures, through faulty well bores, or through leaky confining materials. Contaminants of concern include aqueous salts and dissolved solids, gaseous or aqueous-phase organic contaminants, and acidic gas or aqueous-phase fluids that can liberate metals from aquifer minerals. Understanding the mechanisms and parameters that can contribute to leakage of the CO2 and the ultimate impact on shallow water aquifers that overliemore » injection formations is an important step in evaluating the efficacy and risks associated with long-term CO2 storage. Three students were supported on the grant Training Graduate and Undergraduate Students in Simulation and Risk Assessment for Carbon Sequestration. These three students each examined a different aspect of simulation and risk assessment related to carbon dioxide sequestration and the potential impacts of CO2 leakage. Two performed numerical simulation studies, one to assess leakage rates as a function of fault and deep reservoir parameters and one to develop a method for quantitative risk assessment in the event of a CO2 leak and subsequent changes in groundwater chemistry. A third student performed an experimental evaluation of the potential for metal release from sandstone aquifers under simulated leakage conditions. This study has resulted in two student first-authored published papers {Siirila, 2012 #560}{Kirsch, 2014 #770} and one currently in preparation {Menke, In prep. #809}.« less

  17. Detection of early pancreatic ductal adenocarcinoma using thrombospondin-2 and CA19-9 blood markers

    PubMed Central

    Kim, Jungsun; Bamlet, William R.; Oberg, Ann L.; Chaffee, Kari G.; Donahue, Greg; Cao, Xing-Jun; Chari, Suresh; Garcia, Benjamin A.; Petersen, Gloria M.; Zaret, Kenneth S.

    2017-01-01

    Markers are needed to facilitate early detection of pancreatic ductal adenocarcinoma (PDAC), which is often diagnosed too late for effective therapy. Starting with a PDAC cell reprogramming model that recapitulated the progression of human PDAC, we identified secreted proteins and tested and validated a subset of them as potential markers of PDAC. We optimized an ELISA assay using plasma samples from patients with various stages of PDAC, from individuals with benign pancreatic disease, and from healthy controls. Clinical studies including a phase 1 discovery study (N=20 patients), a phase 2a validation study (N=189), and a second phase 2b validation study (N=537) revealed that concentrations of plasma thrombospondin-2 (THBS2) discriminated among all stages of PDAC consistently over the three studies with a Receiver Operating Characteristic (ROC) c-statistic of 0.76 in Phase 1, 0.842 in Phase 2a, and 0.875 in Phase 2b. The concentration of THBS2 in plasma performed as well at discriminating resectable stage I cancer as stage III/IV PDAC. THBS2 concentrations combined with those for CA19-9, a previously identified PDAC marker, yielded a c-statistic of 0.956 in the Phase 2a study and 0.970 in the Phase 2b study. THBS2 data improved the ability of CA19-9 to distinguish PDAC from pancreatitis. With a specificity of 98%, the combination of THBS2 and CA19-9 yielded a sensitivity of 87% for PDAC in the Phase 2b study. Given this, a THBS2 and CA19-9 panel assessed in human blood using a conventional ELISA assay may improve the detection of patients at high risk for PDAC. PMID:28701476

  18. Para-aortic lymphadenectomy in advanced stage cervical cancer, a protocol for comparing safety, feasibility and diagnostic accuracy of surgical staging versus PET-CT; PALDISC trial.

    PubMed

    Tax, Casper; Abbink, Karin; Rovers, Maroeska M; Bekkers, Ruud L M; Zusterzeel, Petra L M

    2018-01-01

    Currently, a PET-CT is used to assess the need for extended field radiotherapy of para-aortic lymph nodes (PALN) in International Federation of Gynaecology and Obstetrics (FIGO) stage IB2, IIA2-IVA (locally advanced stage) cervical cancer. A small study established a sensitivity and specificity estimate for PALN metastases of 50% (95% CI; 7-93%) and 83% (95% CI; 52-98%), respectively. Surgical staging of PALN may lead to a higher diagnostic accuracy. However, surgical staging of para-aortic lymph nodes in locally advanced stage cervical cancer is not common practice. Therefore, a phase 2 randomised controlled trial is needed to assess its safety and feasibility. In addition to standard imaging (MRI or CT scan) with PET-CT, 30 adult women with FIGO stage IB2, IIA2-IVA cervical cancer will be randomised to receive either surgical staging or usual PET-CT staging. Administering extended field radiotherapy will be based on lymphadenectomy results for the intervention group and on the PET-CT results for the control group. Follow-up visits at 0, 3, 6, 9 and 12 months will assess health-related quality of life and progression-free survival.Primary safety and feasibility outcomes of surgical staging will be assessed by calculating means with 95% confidence intervals for duration of surgery, number of complications, blood loss, nodal yield after para-aortic lymphadenectomy and treatment delay due to surgical staging. Secondary patient-centred outcomes on quality of life and first year survival will be documented and compared between the two groups. Estimates of sensitivity, specificity and negative and positive predictive values of MRI, PET-CT and surgical staging will be presented with 95% CI.. All analysis will be performed according to the intention to treat principle. This study will assess safety and feasibility, expressed as the number and severity of complications, effect on quality of life and the treatment delay due to surgically staging para-aortic lymph nodes in locally advanced cervical cancer. It will provide insight in the diagnostic accuracy of the PET-CT and detection rate of missed (micro)metastases due to surgical staging. This information will be used to assess the necessity for a phase 3 study on the diagnostic accuracy of the PET-CT and surgical staging. If a phase 3 study is deemed necessary, current data can be used for sample size calculation of such a phase 3 study. Nederlands Trial Register/Dutch Trial Registry (www.trialregister.nl), NTR4922. Registered on 24 November 2014.

  19. Metacognitive function poststroke: a review of definition and assessment.

    PubMed

    Al Banna, Mona; Redha, Noor Abdulla; Abdulla, Fatema; Nair, Bindhu; Donnellan, Claire

    2016-02-01

    Metacognition is the conscious knowledge individuals have about their own cognitive capacities and the regulation of these activities through self-monitoring. The aim of this review was to identify the definitions and assessment tools used to examine metacognition in relation to stroke studies. A computer database search was conducted using MEDLINE, CINAHL, PsycINFO, Cochrane Reviews, Scopus and Web of Science. A total of 1412 publications were retrieved from the initial database search. Following the removal of unrelated articles, 34 articles remained eligible. 5 studies examined metacognition in relation to cognitive and/or emotional functioning, 4 examined the concept in relation to memory, while others investigated its relationship to driving, employment or restrictions in daily living. 12 studies examined metacognitive function exclusively in stroke. Only 1 study examined metacognition in the acute phase of stroke. 7 studies adhered to the standard definition of metacognition in line with the neuropsychological literature. The main assessment tools utilised included the Self-Regulation and Skills Interview (SRSI), the Self-Awareness of Deficits Interview (SADI), the Awareness Questionnaire (AQ) and the Patient Competency Rating Scale (PCRS). Assessment of metacognition has tended to focus on traumatic and other acquired brain injury in comparison to stroke. The majority of the studies that examined metacognition in stroke did not assess patients in the acute phase. The heterogeneity of assessment tools was in keeping with the variation in the definition of metacognition. The emergence of a standard metacognitive assessment tool may have important implications for future rehabilitative programmes. 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/

  20. Health status assessment of workers during construction phase of highway rehabilitation projects around lahore, Pakistan

    PubMed Central

    Abrar, Amina; Cheema, Kausar Jamal; Saif, Samia; Mahmood, Asim

    2016-01-01

    Objective: The study focused on assessment of the health status of workers during construction phase of highway rehabilitation projects at six selected sites of N5 around Lahore, including Kala Shah Kaku, Muridke, Kamuki, Bhaipheru, Pattoki, and Okara. Methods: The study was based on multi-methods approach involving hazard identification through survey and checklist as well as a questionnaire for health status assessment and measurements of health parameters including peak expiratory flow rate (PEFR) and audiometric screening of 300 subjects. Results: The study revealed non-congenial working conditions at the sites. Noise, vibrations, dust, asphalt fumes, poor work postures, and injuries were found to be major health hazards. PEFR of most of the workers was found to be significantly lower than the reference value. Average PEFR±SEM values were 187±5.1 l/min, 178±4.3 l/min, and 266±5.3 l/min in ground preparation workers, asphalt workers, and heavy vehicle drivers, respectively. The highest rate (29%) of hearing loss was recorded among heavy vehicle drivers. Musculoskeletal problems were found to be more common among ground preparation workers. Conclusion: Data revealed unsatisfactory health status of most of the workers. Direct relationship between health outcomes and the type of construction activities were observed. The current study focuses on the importance of including occupational health and safety plan in the execution phase of every developmental project that involves construction activities. PMID:27853055

  1. Multidetector CT angiography in living donor renal transplantation: accuracy and discrepancies in right venous anatomy.

    PubMed

    Kulkarni, S; Emre, S; Arvelakis, A; Asch, W; Bia, M; Formica, R; Israel, G

    2011-01-01

    Multidetector computed tomography (MDCT) angiography is a reliable technique for assessing pre-operative renal anatomy in living kidney donors. The method has largely evolved into protocols that eliminate dedicated venous phase and instead utilize a combined arterial/venous phase to delineate arterial and venous anatomy simultaneously. Despite adoption of this protocol, there has been no study to assess its accuracy. To assess whether or not MDCT angiography compares favorably to intra-operative findings, 102 donors underwent MDCT angiography without a dedicated venous phase with surgical interpretation of renal anatomy. Anatomical variants included multiple arteries (12%), multiple veins (7%), early arterial bifurcation (13%), late venous confluence (5%), circumaortic renal veins (5%), retroaortic vein (1%), and ureteral duplication (2%). The sensitivity and specificity of multiple arterial anomalies were 100% and 97%, respectively. The sensitivity and specificity of multiple venous anomalies were 92% and 98%, respectively. The most common discrepancy was noted exclusively in the interpretation of right venous anatomy as it pertained to the renal vein/vena cava confluence (3%). MDCT angiography using a combined arterial/venous contrast-enhanced phase provides suitable depiction of renal donor anatomy. Careful consideration should be given when planning a right donor nephrectomy whether the radiographic interpretation is suggestive of a late confluence. © 2010 John Wiley & Sons A/S.

  2. U.S.-MEXICO BORDER PROGRAM ARIZONA BORDER STUDY

    EPA Science Inventory

    The Arizona Border Study, which measured levels of metals, pesticides, polynuclear aromatic hydrocarbons (PAHs), and volatile organic compounds (VOCs) in the Arizona counties bordering Mexico, is an extension of the Arizona National Human Exposure Assessment Survey (NHEXAS) Phase...

  3. How to conduct External Quality Assessment Schemes for the pre-analytical phase?

    PubMed

    Kristensen, Gunn B B; Aakre, Kristin Moberg; Kristoffersen, Ann Helen; Sandberg, Sverre

    2014-01-01

    In laboratory medicine, several studies have described the most frequent errors in the different phases of the total testing process, and a large proportion of these errors occur in the pre-analytical phase. Schemes for registration of errors and subsequent feedback to the participants have been conducted for decades concerning the analytical phase by External Quality Assessment (EQA) organizations operating in most countries. The aim of the paper is to present an overview of different types of EQA schemes for the pre-analytical phase, and give examples of some existing schemes. So far, very few EQA organizations have focused on the pre-analytical phase, and most EQA organizations do not offer pre-analytical EQA schemes (EQAS). It is more difficult to perform and standardize pre-analytical EQAS and also, accreditation bodies do not ask the laboratories for results from such schemes. However, some ongoing EQA programs for the pre-analytical phase do exist, and some examples are given in this paper. The methods used can be divided into three different types; collecting information about pre-analytical laboratory procedures, circulating real samples to collect information about interferences that might affect the measurement procedure, or register actual laboratory errors and relate these to quality indicators. These three types have different focus and different challenges regarding implementation, and a combination of the three is probably necessary to be able to detect and monitor the wide range of errors occurring in the pre-analytical phase.

  4. Drug development: from concept to marketing!

    PubMed

    Tamimi, Nihad A M; Ellis, Peter

    2009-01-01

    Drug development is an expensive, long and high-risk business taking 10-15 years and is associated with a high attrition rate. It is driven by medical need, disease prevalence and the likelihood of success. Drug candidate selection is an iterative process between chemistry and biology, refining the molecular properties until a compound suitable for advancing to man is found. Typically, about one in a thousand synthesised compounds is ever selected for progression to the clinic. Prior to administration to humans, the pharmacology and biochemistry of the drug is established using an extensive range of in vitro and in vivo test procedures. It is also a regulatory requirement that the drug is administered to animals to assess its safety. Later-stage animal testing is also required to assess carcinogenicity and effects on the reproductive system. Clinical phases of drug development include phase I in healthy volunteers to assess primarily pharmacokinetics, safety and toleration, phase II in a cohort of patients with the target disease to establish efficacy and dose-response relationship and large-scale phase III studies to confirm safety and efficacy. Experience tells us that approximately only 1 in 10 drugs that start the clinical phase will make it to the market. Each drug must demonstrate safety and efficacy in the intended patient population and its benefits must outweigh its risks before it will be approved by the regulatory agencies. Strict regulatory standards govern the conduct of pre-clinical and clinical trials as well as the manufacturing of pharmaceutical products. The assessment of the new medicinal product's safety continues beyond the initial drug approval through post-marketing monitoring of adverse events. Copyright 2009 S. Karger AG, Basel.

  5. Thermodynamic assessment of the U–Y–O system

    DOE PAGES

    Brese, R. G.; McMurray, J. W.; Shin, D.; ...

    2015-02-03

    We developed a CALPHAD assessment of the U-Y-O system. To represent the YO2 compound in the compound energy formalism (CEF) for U 1-yY yO 2± x, the lattice stability was calculated using density functional theory (DFT) while a partially ionic liquid sub-lattice model is used to describe the liquid phase. Moreover, a Gibbs function for the stoichiometric rhombohedral UY 6O 12 phase is proposed. Models representing the phases in the U-O and Y-O systems taken from the literature along with the phases that appear in the U-Y-O ternary are combined to form a unified assessment.

  6. Axitinib in combination with pembrolizumab in patients with advanced renal cell cancer: a non-randomised, open-label, dose-finding, and dose-expansion phase 1b trial.

    PubMed

    Atkins, Michael B; Plimack, Elizabeth R; Puzanov, Igor; Fishman, Mayer N; McDermott, David F; Cho, Daniel C; Vaishampayan, Ulka; George, Saby; Olencki, Thomas E; Tarazi, Jamal C; Rosbrook, Brad; Fernandez, Kathrine C; Lechuga, Mariajose; Choueiri, Toni K

    2018-03-01

    Previous studies combining PD-1 checkpoint inhibitors with tyrosine kinase inhibitors of the VEGF pathway have been characterised by excess toxicity, precluding further development. We hypothesised that axitinib, a more selective VEGF inhibitor than others previously tested, could be combined safely with pembrolizumab (anti-PD-1) and yield antitumour activity in patients with treatment-naive advanced renal cell carcinoma. In this ongoing, open-label, phase 1b study, which was done at ten centres in the USA, we enrolled patients aged 18 years or older who had advanced renal cell carcinoma (predominantly clear cell subtype) with their primary tumour resected, and at least one measureable lesion, Eastern Cooperative Oncology Group performance status 0-1, controlled hypertension, and no previous systemic therapy for renal cell carcinoma. Eligible patients received axitinib plus pembrolizumab in a dose-finding phase to estimate the maximum tolerated dose, and additional patients were enrolled into a dose-expansion phase to further establish safety and determine preliminary efficacy. Axitinib 5 mg was administered orally twice per day with pembrolizumab 2 mg/kg given intravenously every 3 weeks. We assessed safety in all patients who received at least one dose of axitinib or pembrolizumab; antitumour activity was assessed in all patients who received study treatment and had an adequate baseline tumour assessment. The primary endpoint was investigator-assessed dose-limiting toxicity during the first two cycles (6 weeks) to estimate the maximum tolerated dose and recommended phase 2 dose. This study is registered with ClinicalTrials.gov, number NCT02133742. Between Sept 23, 2014, and March 25, 2015, we enrolled 11 patients with previously untreated advanced renal cell carcinoma to the dose-finding phase and between June 3, 2015, and Oct 13, 2015, we enrolled 41 patients to the dose-expansion phase. All 52 patients were analysed together. No unexpected toxicities were observed. Three dose-limiting toxicities were reported in the 11 patients treated during the 6-week observation period (dose-finding phase): one patient had a transient ischaemic attack and two patients were only able to complete less than 75% of the planned axitinib dose because of treatment-related toxicity. At the data cutoff date (March 31, 2017), 25 (48%) patients were still receiving study treatment. Grade 3 or worse treatment-related adverse events occurred in 34 (65%) patients; the most common included hypertension (n=12 [23%]), diarrhoea (n=5 [10%]), fatigue (n=5 [10%]), and increased alanine aminotransferase concentration (n=4 [8%]). The most common potentially immune-related adverse events (probably related to pembrolizumab) included diarrhoea (n=15 [29%]), increased alanine aminotransferase concentration (n=9 [17%]) or aspartate aminotransferase concentration (n=7 [13%]), hypothyroidism (n=7 [13%]), and fatigue (n=6 [12%]). 28 (54%) patients had treatment-related serious adverse events. At data cutoff, 38 (73%; 95% CI 59·0-84·4) patients achieved an objective response (complete or partial response). The treatment combination of axitinib plus pembrolizumab is tolerable and shows promising antitumour activity in patients with treatment-naive advanced renal cell carcinoma. Whether or not the combination works better than a sequence of VEGF pathway inhibition followed by an anti-PD-1 therapy awaits the completion of a phase 3 trial comparing axitinib plus pembrolizumab with sunitinib monotherapy (NCT02853331). Pfizer Inc. Copyright © 2018 Elsevier Ltd. All rights reserved.

  7. Does Assessing Suicidality Frequently and Repeatedly Cause Harm? A Randomized Control Study

    PubMed Central

    Law, Mary Kate; Furr, R. Michael; Arnold, Elizabeth Mayfield; Mneimne, Malek; Jaquett, Caroline; Fleeson, William

    2015-01-01

    Assessing suicidality is common in mental health practice and is fundamental to suicide research. Although necessary, there is significant concern that such assessments have unintended harmful consequences. Using a longitudinal randomized control design, we evaluated whether repeated and frequent assessments of suicide-related thoughts and behaviors negatively affected individuals, including those at-risk for suicide-related outcomes. Adults (N = 282), including many diagnosed with Borderline Personality Disorder (BPD), were recruited through psychiatric outpatient clinics and from the community at large, and were randomly assigned to assessment groups. A Control Assessment group responded to questions regarding negative psychological experiences several times each day during a 2-week Main Observation phase. During the same observation period, an Intensive Suicide Assessment group responded to the same questions, along with questions regarding suicidal behavior and ideation. Negative psychological outcomes were measured during the Main Observation phase (for BPD symptoms unrelated to suicide and for BPD-relevant emotions) and/or at the end of each week during the Main Observation phase and monthly for 6 months thereafter (for all outcomes, including suicidal ideation and behavior). Results revealed little evidence that intensive suicide assessment triggered negative outcomes, including suicidal ideation or behavior, even among people with BPD. A handful of effects did reach or approach significance, though these were temporary and non-robust. However, given the seriousness of some outcomes, we recommend that researchers or clinicians who implement experience sampling methods including suicide-related items carefully consider the benefits of asking about suicide and to inform participants about possible risks. PMID:25894705

  8. Does assessing suicidality frequently and repeatedly cause harm? A randomized control study.

    PubMed

    Law, Mary Kate; Furr, R Michael; Arnold, Elizabeth Mayfield; Mneimne, Malek; Jaquett, Caroline; Fleeson, William

    2015-12-01

    Assessing suicidality is common in mental health practice and is fundamental to suicide research. Although necessary, there is significant concern that such assessments have unintended harmful consequences. Using a longitudinal randomized control design, the authors evaluated whether repeated and frequent assessments of suicide-related thoughts and behaviors negatively affected individuals, including those at-risk for suicide-related outcomes. Adults (N = 282), including many diagnosed with borderline personality disorder (BPD), were recruited through psychiatric outpatient clinics and from the community at large, and were randomly assigned to assessment groups. A control assessment group responded to questions regarding negative psychological experiences several times each day during a 2-week main observation phase. During the same observation period, an intensive suicide assessment group responded to the same questions, along with questions regarding suicidal behavior and ideation. Negative psychological outcomes were measured during the main observation phase (for BPD symptoms unrelated to suicide and for BPD-relevant emotions) and/or at the end of each week during the main observation phase and monthly for 6 months thereafter (for all outcomes, including suicidal ideation and behavior). Results revealed little evidence that intensive suicide assessment triggered negative outcomes, including suicidal ideation or behavior, even among people with BPD. A handful of effects did reach or approach significance, though these were temporary and nonrobust. However, given the seriousness of some outcomes, the authors recommend that researchers or clinicians who implement experience sampling methods including suicide-related items carefully consider the benefits of asking about suicide and to inform participants about possible risks. (c) 2015 APA, all rights reserved).

  9. Using ensemble models to identify and apportion heavy metal pollution sources in agricultural soils on a local scale.

    PubMed

    Wang, Qi; Xie, Zhiyi; Li, Fangbai

    2015-11-01

    This study aims to identify and apportion multi-source and multi-phase heavy metal pollution from natural and anthropogenic inputs using ensemble models that include stochastic gradient boosting (SGB) and random forest (RF) in agricultural soils on the local scale. The heavy metal pollution sources were quantitatively assessed, and the results illustrated the suitability of the ensemble models for the assessment of multi-source and multi-phase heavy metal pollution in agricultural soils on the local scale. The results of SGB and RF consistently demonstrated that anthropogenic sources contributed the most to the concentrations of Pb and Cd in agricultural soils in the study region and that SGB performed better than RF. Copyright © 2015 Elsevier Ltd. All rights reserved.

  10. Life cycle assessment of a road safety product made with virgin and recycled HDPE.

    PubMed

    Simões, Carla L; Xará, Susana M; Bernardo, C A

    2011-04-01

    The present study aims at evaluating the potential environmental impact of using recycled high-density polyethylene (HDPE) in the production of an anti-glare lamella (AGL), a road safety device currently manufactured from virgin (not recycled) polymer. The impact was evaluated using the life cycle assessment (LCA) technique and comparing two alternative systems: current AGL, manufactured from virgin HDPE, and optional AGL, made with recycled HDPE obtained from post-consumer packages. The AGL manufacturing phase was found to be responsible for most of the impacts in both systems, with the production of the raw material being the largest contributor for that phase. The present study makes a contribution to the problem of developing value-added products made from post-consumer polymeric recyclates.

  11. Extinction of aversive classically conditioned human sexual response.

    PubMed

    Brom, Mirte; Laan, Ellen; Everaerd, Walter; Spinhoven, Philip; Both, Stephanie

    2015-04-01

    Research has shown that acquired subjective likes and dislikes are quite resistant to extinction. Moreover, studies on female sexual response demonstrated that diminished genital arousal and positive affect toward erotic stimuli due to aversive classical conditioning did not extinguish during an extinction phase. Possible resistance to extinction of aversive conditioned sexual responses may have important clinical implications. However, resistance to extinction of aversive conditioned human sexual response has not been studied using extensive extinction trials. This article aims to study resistance to extinction of aversive conditioned sexual responses in sexually functional men and women. A differential conditioning experiment was conducted, with two erotic pictures as conditioned stimulus (CSs) and a painful stimulus as unconditioned stimuli (USs). Only one CS (the CS+) was followed by the US during the acquisition phase. Conditioned responses were assessed during the extinction phase. Penile circumference and vaginal pulse amplitude were assessed, and ratings of affective value and subjective sexual arousal were obtained. Also, a stimulus response compatibility task was included to assess automatic approach and avoidance tendencies. Men and women rated the CS+ more negative as compared with the CS-. During the first trials of the extinction phase, vaginal pulse amplitude was lower in response to the CS+ than in response to the CS-, and on the first extinction trial women rated the CS+ as less sexually arousing. Intriguingly, men did not demonstrate attenuated genital and subjective sexual response. Aversive conditioning, by means of painful stimuli, only affects sexual responses in women, whereas it does not in men. Although conditioned sexual likes and dislikes are relatively persistent, conditioned affect eventually does extinguish. © 2014 International Society for Sexual Medicine.

  12. The practical application of adaptive study design in early phase clinical trials: a retrospective analysis of time savings.

    PubMed

    Lorch, U; Berelowitz, K; Ozen, C; Naseem, A; Akuffo, E; Taubel, J

    2012-05-01

    The interest in adaptive study design is evident from the growing amount of clinical research employing this model in the mid to later stages of medicines development. Little has been published on the practical application and merits of adaptive study design in early phase clinical research. This paper describes a retrospective analysis performed on a sample of 29 industry lead adaptive early phase studies commencing between 1 January 2006 and 31 December 2010 in a clinical trials unit in London, England. All studies containing at least one adaptive feature in the original protocol were included in the analysis. The scope of the analysis was to assess whether the use of adaptive study designs provided tangible benefits over the use of conventional study designs using time savings as the main measure. We conclude that the use of adaptive study design saves time in early phase research programs. This is achieved by abolishing the need for substantial amendments or by mitigating their impact on timelines and by using adaptive scheduling efficiencies.

  13. Phases of match-play in professional Australian Football: Descriptive analysis and reliability assessment.

    PubMed

    Rennie, Michael J; Watsford, Mark L; Spurrs, Robert W; Kelly, Stephen J; Pine, Matthew J

    2018-06-01

    To examine the frequency and time spent in the phases of Australian Football (AF) match-play and to assess the intra-assessor reliability of coding these phases of match-play. Observational, intra-reliability assessment. Video footage of 10 random quarters of AF match-play were coded by a single researcher. Phases of offence, defence, contested play, umpire stoppage, set shot and goal reset were coded using a set of operational definitions. Descriptive statistics were provided for all phases of match-play. Following a 6-month washout period, intra-coder reliability was assessed using typical error of measurement (TEM) and intra-class correlation coefficients (ICC). A quarter of AF match-play involved 128±20 different phases of match-play. The highest proportion of match-play involved contested play (25%), followed by offence (18%), defence (18%) and umpire stoppages (18%). The mean duration of offence, defence, contested play, umpire stoppage, set shot and goal reset were 14, 14, 10, 11, 28 and 47s, respectively. No differences were found between the two coding assessments (p>0.05). ICCs for coding the phases of play demonstrated very high reliability (r=0.902-0.992). TEM of the total time spent in each phase of play represented moderate to good reliability (TEM=1.8-9.3%). Coding of offence, defence and contested play tended to display slightly poorer TEMs than umpire stoppages, set shots and goal resets (TEM=8.1 vs 4.5%). Researchers can reliably code the phases of AF match-play which may permit the analysis of specific elements of competition. Copyright © 2017 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

  14. Assessing validity of observational intervention studies - the Benchmarking Controlled Trials.

    PubMed

    Malmivaara, Antti

    2016-09-01

    Benchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations. To create and pilot test a checklist for appraising methodological validity of a BCT. The checklist was created by extracting the most essential elements from the comprehensive set of criteria in the previous paper on BCTs. Also checklists and scientific papers on observational studies and respective systematic reviews were utilized. Ten BCTs published in the Lancet and in the New England Journal of Medicine were used to assess feasibility of the created checklist. The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies. The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies. However, the piloted checklist should be validated in further studies. Key messages Benchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations. This paper presents a checklist for appraising methodological validity of BCTs and pilot-tests the checklist with ten BCTs published in leading medical journals. The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies. The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies.

  15. [Spiral CT of the head-neck area: the advantages of the early arterial phase in the detection of squamous-cell carcinomas].

    PubMed

    Conrad, R; Pauleit, D; Layer, G; Kandyba, J; Kohlbecher, R; Hortling, N; Baselides, P; Schild, H

    1999-07-01

    To determine if scanning in the arterial phase improves detection of squamous cell carcinomas in the pharynx and larynx. In a prospective clinical study 20 patients with a pharyngeal or laryngeal carcinoma were examined with by spiral CT. 80 ml lopromid were intravenously injected as a bolus with a rate of 3 ml/sec. Two consecutive spiral CT scans were performed with start-delay times of 20 and 70 seconds respectively. Delineation and contrast enhancement of tumours, cervical lymph nodes and vessels were evaluated. The radiodensities (HU) of tumors, lymph nodes vessels, pharyngeal wall and muscle were measured. Comparing early and late start delay time scans tumor assessment in the early phase was better in 58%, less in 16% and equal in both scans in 26%. 82% of the pathologic lymph nodes had more peripheral enhancement than surrounding muscle tissue. During the arterial phase the measured radiodensities of the common carotid artery and jugular vein were significantly higher than in the second phase. Contrast-enhanced special CT permits accurate morphologic assessment (size, infiltration) of pharyngeal and supraglottic laryngeal squamous cell carcinoma, while pathologic lymph nodes already have a sufficient contrast enhancement for the detection.

  16. Phase angle and World Health Organization criteria for the assessment of nutritional status in children with osteogenesis imperfecta.

    PubMed

    Pileggi, Vicky Nogueira; Scalize, Antonio Rodolpho Hakime; Camelo Junior, José Simon

    2016-12-01

    To compare the phase angle of patients with osteogenesis imperfecta treated at a tertiary university hospital with patients in a control group of healthy children, and to assess the nutritional status of these patients through the body mass index proposed by the World Health Organization. Cross-sectional study carried out in a university hospital that included seven patients with osteogenesis imperfecta and a control group of 17 healthy children of the same gender and age. Weight and height were measured and bioelectrical impedance was performed. Subsequently, the phase angle was calculated based on resistance and reactance values. The phase angle of the group of children with osteogenesis imperfecta was significantly lower than that of the control group (p<0.05). The body mass index criterion for age of the World Health Organization showed no difference between groups. Children with osteogenesis imperfecta have a nutritional risk detected by the phase angle, which is a useful tool for nutritional screening. The calculation result could help in the diet therapy of patients with osteogenesis imperfecta. Copyright © 2016 Sociedade de Pediatria de São Paulo. Publicado por Elsevier Editora Ltda. All rights reserved.

  17. Open-label dose optimization of methylphenidate modified release long acting (MPH-LA): a post hoc analysis of real-life titration from a 40-week randomized trial.

    PubMed

    Huss, Michael; Ginsberg, Ylva; Arngrim, Torben; Philipsen, Alexandra; Carter, Katherine; Chen, Chien-Wei; Gandhi, Preetam; Kumar, Vinod

    2014-09-01

    In the management of attention-deficit hyperactivity disorder (ADHD) in adults it is important to recognize that individual patients respond to a wide range of methylphenidate doses. Studies with methylphenidate modified release long acting (MPH-LA) in children have reported the need for treatment optimization for improved outcomes. We report the results from a post hoc analysis of a 5-week dose optimization phase from a large randomized, placebo-controlled, multicenter 40-week study (9-week double-blind dose confirmation phase, 5-week open-label dose optimization phase, and 26-week double-blind maintenance of effect phase). Patients entering the open-label dose optimization phase initiated treatment with MPH-LA 20 mg/day; up/down titrated to their optimal dose (at which there was balance between control of symptoms and side effects) of 40, 60, or 80 mg/day in increments of 20 mg/week by week 12 or 13. Safety was assessed by monitoring the adverse events (AEs) and serious AEs. Efficacy was assessed by the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, Attention-Deficit Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) and Sheehan Disability Scale (SDS) total scores. At the end of the dose confirmation phase, similar numbers of patients were treated optimally with each of the 40, 60, and 80 mg/day doses (152, 177, and 160, respectively) for MPH-LA. Mean improvement from baseline in the dose confirmation phase in total scores of DSM-IV ADHD RS and SDS were 23.5 ± 9.90 and 9.7 ± 7.36, respectively. Dose optimization with MPH-LA (40, 60, or 80 mg/day) improved treatment outcomes and was well-tolerated in adult ADHD patients.

  18. Epigenetic Therapy Using Belinostat for Patients With Unresectable Hepatocellular Carcinoma: A Multicenter Phase I/II Study With Biomarker and Pharmacokinetic Analysis of Tumors From Patients in the Mayo Phase II Consortium and the Cancer Therapeutics Research Group

    PubMed Central

    Yeo, Winnie; Chung, Hyun C.; Chan, Stephen L.; Wang, Ling Z.; Lim, Robert; Picus, Joel; Boyer, Michael; Mo, Frankie K.F.; Koh, Jane; Rha, Sun Y.; Hui, Edwin P.; Jeung, Hei C.; Roh, Jae K.; Yu, Simon C.H.; To, Ka F.; Tao, Qian; Ma, Brigette B.; Chan, Anthony W.H.; Tong, Joanna H.M.; Erlichman, Charles; Chan, Anthony T.C.; Goh, Boon C.

    2012-01-01

    Purpose Epigenetic aberrations have been reported in hepatocellular carcinoma (HCC). In this study of patients with unresectable HCC and chronic liver disease, epigenetic therapy with the histone deacetylase inhibitor belinostat was assessed. The objectives were to determine dose-limiting toxicity and maximum-tolerated dose (MTD), to assess pharmacokinetics in phase I, and to assess activity of and explore potential biomarkers for response in phase II. Patients and Methods Major eligibility criteria included histologically confirmed unresectable HCC, European Cooperative Oncology Group performance score ≤ 2, and adequate organ function. Phase I consisted of 18 patients; belinostat was given intravenously once per day on days 1 to 5 every 3 weeks; dose levels were 600 mg/m2 per day (level 1), 900 mg/m2 per day (level 2), 1,200 mg/m2 per day (level 3), and 1,400 mg/m2 per day (level 4). Phase II consisted of 42 patients. The primary end point was progression-free survival (PFS), and the main secondary end points were response according to Response Evaluation Criteria in Solid Tumors (RECIST) and overall survival (OS). Exploratory analysis was conducted on pretreatment tumor tissues to determine whether HR23B expression is a potential biomarker for response. Results Belinostat pharmacokinetics were linear from 600 to 1,400 mg/m2 without significant accumulation. The MTD was not reached at the maximum dose administered. Dose level 4 was used in phase II. The median number of cycles was two (range, one to 12). The partial response (PR) and stable disease (SD) rates were 2.4% and 45.2%, respectively. The median PFS and OS were 2.64 and 6.60 months, respectively. Exploratory analysis revealed that disease stabilization rate (complete response plus PR plus SD) in tumors having high and low HR23B histoscores were 58% and 14%, respectively (P = .036). Conclusion Epigenetic therapy with belinostat demonstrates tumor stabilization and is generally well-tolerated. HR23B expression was associated with disease stabilization. PMID:22915658

  19. Laboratory validation of an in-home method for assessing circadian phase using dim light melatonin onset (DLMO).

    PubMed

    Pullman, Rebecca E; Roepke, Stephanie E; Duffy, Jeanne F

    2012-06-01

    To determine whether an accurate circadian phase assessment could be obtained from saliva samples collected by patients in their home. Twenty-four individuals with a complaint of sleep initiation or sleep maintenance difficulty were studied for two evenings. Each participant received instructions for collecting eight hourly saliva samples in dim light at home. On the following evening they spent 9h in a laboratory room with controlled dim (<20 lux) light where hourly saliva samples were collected. Circadian phase of dim light melatonin onset (DLMO) was determined using both an absolute threshold (3 pg ml(-1)) and a relative threshold (two standard deviations above the mean of three baseline values). Neither threshold method worked well for one participant who was a "low-secretor". In four cases the participants' in-lab melatonin levels rose much earlier or were much higher than their at-home levels, and one participant appeared to take the at home samples out of order. Overall, the at-home and in-lab DLMO values were significantly correlated using both methods, and differed on average by 37 (± 19)min using the absolute threshold and by 54 (± 36)min using the relative threshold. The at-home assessment procedure was able to determine an accurate DLMO using an absolute threshold in 62.5% of the participants. Thus, an at-home procedure for assessing circadian phase could be practical for evaluating patients for circadian rhythm sleep disorders. Copyright © 2012 Elsevier B.V. All rights reserved.

  20. Advanced Collaborative Emissions Study (ACES)

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

    Greenbaum, Daniel; Costantini, Maria; Van Erp, Annemoon

    2013-12-31

    The objective of the Advanced Collaborative Emissions Study (ACES) was to determine before widespread commercial deployment whether or not the new, energy-efficient, heavy duty diesel engines (2007 and 2010 EPA Emissions Standards Compliant) may generate anticipated toxic emissions that could adversely affect the environment and human health. ACES was planned to take place in three phases. In Phase 1, extensive emissions characterization of four production-intent prototype engine and control systems designed to meet 2007 standards for nitrogen oxides (NOx) and particulate matter (PM) was conducted at an existing emissions characterization facility: Southwest Research Institute (SwRI). One of the tested enginesmore » was selected (at random, after careful comparison of results) for health testing in Phase 3. In Phase 2, extensive emission characterization of three production-intent prototype engine and control systems meeting the 2010 standards (including more advanced NOx controls to meet the more stringent 2010 NOx standards) was conducted at the same test facility. In Phase 3, one engine/aftertreatment system selected from Phase 1 was further characterized during health effects studies (at an existing inhalation toxicology laboratory: Lovelace Respiratory Research Institute, [LRRI]) to form the basis of the ACES safety assessment. The Department of Energy (DOE) award provided funding for emissions characterization in Phases 1 and 2 as well as exposure characterization in Phase 3. The main health analyses in Phase 3 were funded separately and are not reported here.« less

  1. Encouraging translation and assessing impact of the Centre for Research Excellence in Integrated Quality Improvement: rationale and protocol for a research impact assessment

    PubMed Central

    Ramanathan, Shanthi; Reeves, Penny; Deeming, Simon; Bailie, Ross Stewart; Bailie, Jodie; Bainbridge, Roxanne; Cunningham, Frances; Doran, Christopher; McPhail Bell, Karen; Searles, Andrew

    2017-01-01

    Introduction There is growing recognition among health researchers and funders that the wider benefits of research such as economic, social and health impacts ought to be assessed and valued alongside academic outputs such as peer-reviewed papers. Research translation needs to increase and the pathways to impact ought to be more transparent. These processes are particularly pertinent to the Indigenous health sector given continued concerns that Indigenous communities are over-researched with little corresponding improvement in health outcomes. This paper describes the research protocol of a mixed methods study to apply FAIT (Framework to Assess the Impact from Translational health research) to the Centre for Research Excellence in Integrated Quality Improvement (CRE-IQI). FAIT will be applied to five selected CRE-IQI Flagship projects to encourage research translation and assess the wider impact of that research. Methods and analysis Phase I will develop a modified programme logic model for each Flagship project including identifying process, output and impact metrics so progress can be monitored. A scoping review will inform potential benefits. In phase II, programme logic models will be updated to account for changes in the research pathways over time. Audit and feedback will be used to encourage research translation and collect evidence of achievement of any process, output and interim impacts. In phase III, three proven methodologies for measuring research impact—Payback, economic assessment and narratives—will be applied. Data on the application of FAIT will be collected and analysed to inform and improve FAIT’s performance. Ethics and dissemination This study is funded by a nationally competitive grant (ID 1078927) from the Australian National Health and Medical Research Council. Ethics approval was obtained from the University of Newcastle’s Human Research Ethics Committee (ID: H-2017–0026). The results from the study will be presented in several peer-reviewed publications, through conference presentations and via social media. PMID:29208619

  2. Organisational justice and cognitive function in middle-aged employees: the Whitehall II study.

    PubMed

    Elovainio, Marko; Singh-Manoux, Archana; Ferrie, Jane E; Shipley, Martin; Gimeno, David; De Vogli, Roberto; Vahtera, Jussi; Virtanen, Marianna; Jokela, Markus; Marmot, Michael G; Kivimäki, Mika

    2012-06-01

    Little is known about the role that work-related factors play in the decline of cognitive function. This study examined the association between perceived organisational justice and cognitive function among middle-aged men and women. Perceived organisational justice was measured at phases 1 (1985-8) and 2 (1989-90) of the Whitehall II study when the participants were 35-55 years old. Assessment of cognitive function at the screening clinic at phases 5 (1997-9) and 7 (2003-4) included the following tests in the screening clinic: memory, inductive reasoning (Alice Heim 4), vocabulary (Mill Hill), and verbal fluency (phonemic and semantic). Mean exposure to lower organisational justice at phases 1 and 2 in relation to cognitive function at phases 5 and 7 were analysed using linear regression analyses. The final sample included 4531 men and women. Lower mean levels of justice at phases 1 and 2 were associated with worse cognitive function in terms of memory, inductive reasoning, vocabulary and verbal fluency at both phases 5 and 7. These associations were independent of covariates, such as age, occupational grade, behavioural risks, depression, hypertension and job strain. This study suggests an association between perceived organisational justice and cognitive function. Further studies are needed to examine whether interventions designed to improve organisational justice would affect employees' cognition function favourably.

  3. EffectS of non-nutritive sWeetened beverages on appetITe during aCtive weigHt loss (SWITCH): Protocol for a randomized, controlled trial assessing the effects of non-nutritive sweetened beverages compared to water during a 12-week weight loss period and a follow up weight maintenance period.

    PubMed

    Masic, U; Harrold, J A; Christiansen, P; Cuthbertson, D J; Hardman, C A; Robinson, E; Halford, J C G

    2017-02-01

    Acute and medium-term intervention studies suggest that non-nutritive sweeteners (NNS) are beneficial for weight loss, however there is limited human data on the long-term effects of consuming NNS on weight loss, maintenance, and appetite. Further research is therefore required to elucidate the prolonged impact of NNS consumption on these outcome measures. A randomized parallel groups design will be used to assess whether regular NNS beverage intake is equivalent to a water control in promoting weight loss over 12-weeks (weekly weight loss sessions; Phase I), then supporting weight maintenance over 40-weeks (monthly sessions; Phase II) and subsequently independent weight maintenance over 52-weeks (Phase III) in 432 participants. A subset of these participants (n=116) will complete laboratory-based appetite probe days (15 sessions; 3 sessions each at baseline, at the start of phase I and the end of each phase). A separate subset (n=50) will complete body composition scans (DXA) at baseline and at the end of each phase. All participants will regularly be weighed and will complete questionnaires and cognitive tasks to assess changes in body weight and appetitive behaviours. Measures of physical activity and biochemical markers will also be taken. The trial will assess the efficacy of NNS beverages compared to water during a behavioural weight loss and maintenance programme. We aim to understand whether the impact of NNS on weight, dietary adherence and well-being are beneficial or transient and effects on prolonged successful weight loss and weight maintenance through sustained changes in appetite and eating behaviour. Clinical Trials: NCT02591134; registered: 23.10.2015. Crown Copyright © 2016. Published by Elsevier Inc. All rights reserved.

  4. Multi-phase distribution and comprehensive ecological risk assessment of heavy metal pollutants in a river affected by acid mine drainage.

    PubMed

    Liao, Jianbo; Ru, Xuan; Xie, Binbin; Zhang, Wanhui; Wu, Haizhen; Wu, Chaofei; Wei, Chaohai

    2017-07-01

    To date, there is a lack of a comprehensive research on heavy metals detection and ecological risk assessment in river water, sediments, pore water (PW) and suspended solids (SS). Here, the concentrations of heavy metals, including Cu, Zn, Mn, Cd, Pb and As, and their distribution between the four phases was studied. Samples for analysis were taken from twelve sites of the Hengshi River, Guangdong Province, China, during the rainy and dry seasons. A new comprehensive ecological risk index (CERI) based on considering metal contents, pollution indices, toxicity coefficients and water categories is offered for prediction of potential risk on aquatic organisms. The results of comprehensive analysis showed that the highest concentrations of Cu, Zn and Mn of 6.42, 87.17 and 98.74mg/L, respectively, in PW were comparable with those in water, while concentrations of Cd, Pb and As of 609.5, 2757 and 96.38μg/L, respectively, were 2-5 times higher. The sum of the exchangeable and carbonate fractions of target metals in sediments followed the order of Cd > Mn > Zn > Pb > Cu > As. The distribution of heavy metals in phases followed the order of sediment > SS > water > PW, having the sum content in water and PW lower than 2% of total. The elevated ecological risk for a single metal and the phase were 34,585 for Cd and 1160 for water, respectively, implied Cd as a priority pollutant in the considered area. According to the CERI, the maximum risk value of 769.3 was smaller than 1160 in water, but higher than those in other phases. Out of considering the water categories and contribution coefficients, the CERI was proved to be more reliable for assessing the pollution of rivers with heavy metals. These results imply that the CERI has a potential of adequate assessment of multi-phase composite metals pollution. Copyright © 2017 Elsevier Inc. All rights reserved.

  5. Two-dimensional and three-dimensional viability measurements of adult stem cells with optical coherence phase microscopy

    NASA Astrophysics Data System (ADS)

    Bagnaninchi, Pierre O.; Holmes, Christina; Drummond, Nicola; Daoud, Jamal; Tabrizian, Maryam

    2011-08-01

    Cell viability assays are essential tools for cell biology. They assess healthy cells in a sample and enable the quantification of cellular responses to reagents of interest. Noninvasive and label-free assays are desirable in two-dimensional (2D) and three-dimensional (3D) cell culture to facilitate time-course viability studies. Cellular micromotion, emanating from cell to substrate distance variations, has been demonstrated as a marker of cell viability with electric cell-substrate impedance sensing (ECIS). In this study we investigated if optical coherence phase microscopy (OCPM) was able to report phase fluctuations of adult stem cells in 2D and 3D that could be associated with cellular micromotion. An OCPM has been developed around a Thorlabs engine (λo = 930 nm) and integrated in an inverted microscope with a custom scanning head. Human adipose derived stem cells (ADSCs, Invitrogen) were cultured in Mesenpro RS medium and seeded either on ECIS arrays, 2D cell culture dishes, or in 3D highly porous microplotted polymeric scaffolds. ADSC micromotion was confirmed by ECIS analysis. Live and fixed ADSCs were then investigated in 2D and 3D with OCPM. Significant differences were found in phase fluctuations between the different conditions. This study indicated that OCPM could potentially assess cell vitality in 2D and in 3D microstructures.

  6. Determination of the effect of lift characteristics on dynamic performance profiles during manual materials handling tasks.

    PubMed

    Khalaf, K A; Parnianpour, M; Sparto, P J; Barin, K

    1999-01-01

    In any quantitative gait or occupational biomechanics investigation, the quantification of the different kinematic, kinetic, and electromyographic parameters is essential towards assessment of functional capacity and development of a biomechanical profile of the task demands. In the current study, the authors presented a methodology for using inferential statistics to evaluate the effect of lift characteristics on phase-dependent and phase-independent variability in performance. Using a database of kinematic and kinetic profiles obtained from a manual lifting study, the phase-dependent effects of lift characteristics: box mass (load), mode (technique of lift), and speed (frequency of lift) were investigated through the use of analysis of variance (ANOVA) techniques, which recognize the vectorial constitution of the profiles. In addition, the Karhunen-Loeve Expansion (KLE) feature extraction method was used for representing the lifting patterns of measured joint angular position, velocity, acceleration, and net muscular torque profiles obtained from a 2-D biomechanical lifting model in order to study the phase-independent effects. In comparison to traditional descriptive statistical analyses currently used in various occupational biomechanics experimental investigations, this method allows the significant information content of the time varying signal to be captured, enhancing the sensitivity of subsequent hypothesis testing procedures. The application of this technique to MMH investigations allows identification of the lift characteristics that dominate the variability of task demands, hence aiding in the design and assessment of ergonomic solutions.

  7. Superfluid helium 2 liquid-vapor phase separation: Technology assessment

    NASA Technical Reports Server (NTRS)

    Lee, J. M.

    1984-01-01

    A literature survey of helium 2 liquid vapor phase separation is presented. Currently, two types of He 2 phase separators are being investigated: porous, sintered metal plugs and the active phase separator. The permeability K(P) shows consistency in porous plug geometric characterization. Both the heat and mass fluxes increase with K(P). Downstream pressure regulation to adjust for varying heat loads and both temperatures is possible. For large dynamic heat loads, the active phase separator shows a maximum heat rejection rate of up to 2 W and bath temperature stability of 0.1 mK. Porous plug phase separation performance should be investigated for application to SIRTF and, in particular, that plugs of from 10 to the minus ninth square centimeters to 10 to the minus eighth square centimeters in conjunction with downstream pressure regulation be studied.

  8. Assessing the Economic and Environmental Impacts Associated with Current Street Lighting Technologies

    DTIC Science & Technology

    2010-03-01

    AFIT/GEM/ENV/10-M01 Abstract Rising global energy demand and natural disasters continuously threaten energy supplies and prices. As a result , the...light bulbs. The study used the Process-Sum and Economic Input-Output Life-cycle Assessment (EIO- LCA ) methods. The results of the study found that... results for this phase of the analysis. Summary This chapter has detailed the methodology used in this study. Using both LCCA and EIO- LCA allowed for

  9. Study of a conceptual nuclear energy center at Green River, Utah. Power demand, load center assessment and transmission

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

    Smith, D.R.; Thaik, A.; Pingel, P.

    This document constitutes a segment of a feasibility study investigating the ramification of constructing a nuclear energy center in an arid western region. In this phase of the study. The projected power demands and load center locations were reviewed and assessed. Alternative transmission systems were analysed and a conceptual transmission for bulk power transportation is proposed with potential line routes. Environmental impacts of the proposed transmission were also identified.

  10. Bioelectrical impedance phase angle relates to function, disease severity and prognosis in stable chronic obstructive pulmonary disease.

    PubMed

    Maddocks, Matthew; Kon, Samantha S C; Jones, Sarah E; Canavan, Jane L; Nolan, Claire M; Higginson, Irene J; Gao, Wei; Polkey, Michael I; Man, William D-C

    2015-12-01

    Bioelectrical impedance analysis (BIA) provides a simple method to assess changes in body composition. Raw BIA variables such as phase angle provide direct information on cellular mass and integrity, without the assumptions inherent in estimating body compartments, e.g. fat-free mass (FFM). Phase angle is a strong functional and prognostic marker in many disease states, but data in COPD are lacking. Our aims were to describe the measurement of phase angle in patients with stable COPD and determine the construct and discriminate validity of phase angle by assessing its relationship with established markers of function, disease severity and prognosis. 502 outpatients with stable COPD were studied. Phase angle and FFM by BIA, quadriceps strength (QMVC), 4-m gait speed (4MGS), 5 sit-to-stand time (5STS), incremental shuttle walk (ISW), and composite prognostic indices (ADO, iBODE) were measured. Patients were stratified into normal and low phase angle and FFM index. Phase angle correlated positively with FFM and functional outcomes (r = 0.35-0.66, p < 0.001) and negatively with prognostic indices (r = -0.35 to -0.48, p < 0.001). In regression models, phase angle was independently associated with ISW, ADO and iBODE whereas FFM was removed. One hundred and seventy patients (33.9% [95% CI, 29.9-38.1]) had a low phase angle. Phenotypic characteristics included lower QMVC, ISW, and 4MGS, higher 5STS, ADO and iBODE scores, and more exacerbations and hospital days in past year. The proportion of patients to have died was significantly higher in patients with low phase angle compared to those with normal phase angle (8.2% versus 3.6%, p = 0.02). Phase angle relates to markers of function, disease severity and prognosis in patients with COPD. As a directly measured variable, phase angle offers more useful information than fat-free mass indices. Copyright © 2015 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  11. Do all patients in the phase I oncology trials need to be hospitalized? Domestic but outstanding issues for globalization of drug development in Japan.

    PubMed

    Shimomura, Akihiko; Kondo, Shunsuke; Kobayashi, Noriko; Iwasa, Satoru; Kitano, Shigehisa; Tamura, Kenji; Fujiwara, Yutaka; Yamamoto, Noboru

    2017-08-01

    Most trials investigating new drugs around the world, including phase I trials, are conducted in outpatient clinics. However, in Japan, regulatory authority requirements and traditional domestic guidelines often require hospitalization of phase I study participants. Patients participating in single-agent phase I clinical trials at National Cancer Center Hospital between December 1996 and August 2014 were monitored. Toxicity requiring hospitalization is defined as toxicity that needs intensive treatment. Study designs were classified into three types: first-in-human (FIH) study, dose-escalation study (conventional dose-escalation study to determine maximum tolerated dose (MTD) in Japanese patients), and dose-finding study (to assess safety and pharmacokinetic profiles up to the MTD previously determined in the West). A total of 945 patients who participated in a variety of single-agent phase I clinical trials between December 1996 and August 2014 were included in this study. Patients participated in one of three study types: dose-escalation (n = 582, 62%), first-in-human (n = 129, 14%), or dose-finding (n = 234, 25%). A total of 76 study drugs were evaluated as part of this pool of phase I studies. Subdivided by mechanism of action, 20 (26%) were cytotoxic, 50 (66%) were molecularly targeted, and 6 (8%) were immune checkpoint inhibitor. Thirty-six patients (3.8%) had severe toxicities requiring hospitalization during the first cycle. The overall number of toxicities requiring hospitalization and/or grade 4 toxicities during any cycle was 5.0%. The frequency of severe toxicity that needs to be hospitalized was unexpectedly low. The data did not demonstrate the need for hospitalization in the phase I trials, suggesting that phase I trials in Japan could be conducted in outpatient settings.

  12. Effects of endogenous and exogenous progesterone on emotional intelligence in cocaine dependent men and women who also abuse alcohol

    PubMed Central

    Milivojevic, V; Sinha, R; Morgan, PT; Sofuoglu, M; Fox, HC

    2015-01-01

    Objective As sex differences in substance dependence may impinge upon the perception and regulation of emotion, we assess Emotional Intelligence (EI) as a function of gender, menstrual cycle (MC) phase and hormonal changes in early abstinent cocaine dependent individuals who abuse alcohol (CDA). Methods Study 1: The Mayer, Salovey, and Caruso Emotional Intelligence Test (MSCEIT) was administered to 98 CDA (55M/43F) and 56 healthy (28M/28F) individuals. Performance in women was also assessed by MC phase. Study 2: The MSCEIT was administered to 18 CDA (19M/9F) who received exogenous progesterone (400mg/day) versus placebo for 7 days. (Study 2). Results Study 1: Healthy females were better than healthy males at facilitating thought and managing emotions. This gender discrepancy was not observed in the CDA group. Additionally, all women in the high compared with the low progesterone phase of their MC were better at managing their emotions. Study 2: Exogenous progesterone improved ability to facilitate thought in both males and females. Conclusions CDA women may be vulnerable to difficulties managing and regulating emotions. Gonadal hormones may contribute to this gender effect, as increases in both endogenous and exogenous progesterone improved selective aspects of EI. PMID:25363303

  13. Effects of sensorimotor foot training on the symmetry of weight distribution on the lower extremities of patients in the chronic phase after stroke

    PubMed Central

    Goliwas, Magdalena; Kocur, Piotr; Furmaniuk, Lech; Majchrzycki, Marian; Wiernicka, Marzena; Lewandowski, Jacek

    2015-01-01

    [Purpose] To assess the effects of sensorimotor foot stimulation on the symmetry of weight distribution on the feet of patients in the chronic post-stroke phase. [Subjects and Methods] This study was a prospective, single blind, randomized controlled trial. In the study we examined patients with chronic stroke (post-stroke duration > 1 year). They were randomly allocated to the study group (n=8) or to the control group (n=12). Both groups completed a standard six-week rehabilitation programme. In the study group, the standard rehabilitation programme was supplemented with sensorimotor foot stimulation training. Each patient underwent two assessments of symmetry of weight distribution on the lower extremities with and without visual control, on a treadmill, with stabilometry measurements, and under static conditions. [Results] Only the study group demonstrated a significant increase in the weight placed on the leg directly affected by stroke, and a reduction in asymmetry of weight-bearing on the lower extremities. [Conclusion] Sensorimotor stimulation of the feet enhanced of weight bearing on the foot on the side of the body directly affected by stroke, and a decreased asymmetry of weight distribution on the lower extremities of patients in the chronic post-stroke phase. PMID:26504326

  14. Effects of sensorimotor foot training on the symmetry of weight distribution on the lower extremities of patients in the chronic phase after stroke.

    PubMed

    Goliwas, Magdalena; Kocur, Piotr; Furmaniuk, Lech; Majchrzycki, Marian; Wiernicka, Marzena; Lewandowski, Jacek

    2015-09-01

    [Purpose] To assess the effects of sensorimotor foot stimulation on the symmetry of weight distribution on the feet of patients in the chronic post-stroke phase. [Subjects and Methods] This study was a prospective, single blind, randomized controlled trial. In the study we examined patients with chronic stroke (post-stroke duration > 1 year). They were randomly allocated to the study group (n=8) or to the control group (n=12). Both groups completed a standard six-week rehabilitation programme. In the study group, the standard rehabilitation programme was supplemented with sensorimotor foot stimulation training. Each patient underwent two assessments of symmetry of weight distribution on the lower extremities with and without visual control, on a treadmill, with stabilometry measurements, and under static conditions. [Results] Only the study group demonstrated a significant increase in the weight placed on the leg directly affected by stroke, and a reduction in asymmetry of weight-bearing on the lower extremities. [Conclusion] Sensorimotor stimulation of the feet enhanced of weight bearing on the foot on the side of the body directly affected by stroke, and a decreased asymmetry of weight distribution on the lower extremities of patients in the chronic post-stroke phase.

  15. Effects of endogenous and exogenous progesterone on emotional intelligence in cocaine-dependent men and women who also abuse alcohol.

    PubMed

    Milivojevic, Verica; Sinha, Rajita; Morgan, Peter T; Sofuoglu, Mehmet; Fox, Helen C

    2014-11-01

    As sex differences in substance dependence may impinge upon the perception and regulation of emotion, we assess emotional intelligence (EI) as a function of gender, menstrual cycle (MC) phase and hormonal changes in early abstinent cocaine-dependent individuals who abuse alcohol (CDA). Study 1: The Mayer, Salovey, and Caruso Emotional Intelligence Test (MSCEIT) was administered to 98 CDA (55 M/43 F) and 56 healthy (28 M/28 F) individuals. Performance in women was also assessed by MC phase. Study 2: The MSCEIT was administered to 28 CDA (19 M/9 F) who received exogenous progesterone (400 mg/day) versus placebo for 7 days (study 2). Study 1: Healthy females were better than healthy males at facilitating thought and managing emotions. This gender discrepancy was not observed in the CDA group. Additionally, all women in the high compared with the low progesterone phase of their MC were better at managing their emotions. Study 2: Exogenous progesterone improved ability to facilitate thought in both males and females. CDA women may be vulnerable to difficulties managing and regulating emotions. Gonadal hormones may contribute to this gender effect, as increases in both endogenous and exogenous progesterone improved selective aspects of EI. Copyright © 2014 John Wiley & Sons, Ltd.

  16. Predictors of Hypoglycemia in the ASPIRE In-Home Study and Effects of Automatic Suspension of Insulin Delivery.

    PubMed

    Weiss, Ram; Garg, Satish K; Bergenstal, Richard M; Klonoff, David C; Bode, Bruce W; Bailey, Timothy S; Thrasher, James; Schwartz, Frank; Welsh, John B; Kaufman, Francine R

    2015-05-18

    Hypoglycemia varies between patients with type 1 diabetes and is the main obstacle to therapy intensification. We investigated known and potential risk factors for hypoglycemia in subjects with type 1 diabetes. In the ASPIRE In-Home study (NCT01497938), a randomized trial of the threshold suspend (TS) feature of sensor-augmented insulin pump (SAP) therapy, subjects' propensity to nocturnal hypoglycemia (NH) was established in a 2-week run-in phase and assessed in a 3-month study phase via continuous glucose monitoring. Categorical variables were tested for association with NH rates in both phases. Elevated rates of NH were significantly associated with baseline A1C ≤7%, with bolus insulin deliveries unassisted by the bolus estimation calculator, and with assignment to the control group during the study phase. Routine use of the TS feature and the bolus estimation calculator are strategies that may reduce the risk of NH. © 2015 Diabetes Technology Society.

  17. Cost effectiveness of adopted quality requirements in hospital laboratories.

    PubMed

    Hamza, Alneil; Ahmed-Abakur, Eltayib; Abugroun, Elsir; Bakhit, Siham; Holi, Mohamed

    2013-01-01

    The present study was designed in quasi-experiment to assess adoption of the essential clauses of particular clinical laboratory quality management requirements based on international organization for standardization (ISO 15189) in hospital laboratories and to evaluate the cost effectiveness of compliance to ISO 15189. The quality management intervention based on ISO 15189 was conceded through three phases; pre - intervention phase, Intervention phase and Post-intervention phase. In pre-intervention phase the compliance to ISO 15189 was 49% for study group vs. 47% for control group with P value 0.48, while the post intervention results displayed 54% vs. 79% for study group and control group respectively in compliance to ISO 15189 and statistically significant difference (P value 0.00) with effect size (Cohen's d) of (0.00) in pre-intervention phase and (0.99) in post - intervention phase. The annual average cost per-test for the study group and control group was 1.80 ± 0.25 vs. 1.97 ± 0.39, respectively with P value 0.39 whereas the post-intervention results showed that the annual average total costs per-test for study group and control group was 1.57 ± 0.23 vs 2.08 ± 0.38, P value 0.019 respectively, with cost-effectiveness ratio of (0.88) in pre -intervention phase and (0.52) in post-intervention phase. The planned adoption of quality management requirements (QMS) in clinical laboratories had great effect to increase the compliance percent with quality management system requirement, raise the average total cost effectiveness, and improve the analytical process capability of the testing procedure.

  18. A study of fault prediction and reliability assessment in the SEL environment

    NASA Technical Reports Server (NTRS)

    Basili, Victor R.; Patnaik, Debabrata

    1986-01-01

    An empirical study on estimation and prediction of faults, prediction of fault detection and correction effort, and reliability assessment in the Software Engineering Laboratory environment (SEL) is presented. Fault estimation using empirical relationships and fault prediction using curve fitting method are investigated. Relationships between debugging efforts (fault detection and correction effort) in different test phases are provided, in order to make an early estimate of future debugging effort. This study concludes with the fault analysis, application of a reliability model, and analysis of a normalized metric for reliability assessment and reliability monitoring during development of software.

  19. Luteal phase clomiphene citrate for ovulation induction in women with polycystic ovary syndrome: a systematic review and meta-analysis.

    PubMed

    Ding, Nan; Chang, Jianbo; Jian, Qiliang; Liang, Xuefei; Liang, Zhongzhen; Wang, Fang

    2016-11-01

    To assess the efficacy of late luteal phase clomiphene citrate (CC) administration relative to early follicular phase CC for ovulation induction for polycystic ovary syndrome (PCOS). Review. A complete electronic databases including PubMed, Embase, The Cochrane Library, Web of Science, and CBM were searched for relevant randomized controlled trials (RCTs). The search was not restricted by language and publication time. Two reviewers selected trials and assessed trial quality by the Cochrane Handbook 5.1.0 independently. Four eligible RCT studies involving 708 women (934 cycles) were included. The results of the Meta-analysis: Late luteal phase group was associated with a number of higher total follicles (MD 1.82; 95% CI 0.86-2.78, p < 0.00001) and significant higher endometrial thickness on the day of HCG (MD 0.88; 95% CI 0.78-0.99, p < 0.00001) compared with early follicular group. There were no significant differences in the rate of pregnancy (RR 1.29; 95% CI 0.83-2.01, p = 0.26), ovulation rate (RR 0.99; 95% CI 0.86-1.14, p = 0.87), and abortion rate (RR 1.12; 95% CI 0.38 to 3.29, p = 0.84) between the two groups. It appeared that late luteal phase CC for ovulation induction might be an effective method for ovulation induction in women with PCOS compared to conventional CC administration. Further intensive randomized-controlled studies should be warranted to define the efficacy of CC used in late luteal phase.

  20. Multimodal pressure-flow method to assess dynamics of cerebral autoregulation in stroke and hypertension.

    PubMed

    Novak, Vera; Yang, Albert C C; Lepicovsky, Lukas; Goldberger, Ary L; Lipsitz, Lewis A; Peng, Chung-Kang

    2004-10-25

    This study evaluated the effects of stroke on regulation of cerebral blood flow in response to fluctuations in systemic blood pressure (BP). The autoregulatory dynamics are difficult to assess because of the nonstationarity and nonlinearity of the component signals. We studied 15 normotensive, 20 hypertensive and 15 minor stroke subjects (48.0 +/- 1.3 years). BP and blood flow velocities (BFV) from middle cerebral arteries (MCA) were measured during the Valsalva maneuver (VM) using transcranial Doppler ultrasound. A new technique, multimodal pressure-flow analysis (MMPF), was implemented to analyze these short, nonstationary signals. MMPF analysis decomposes complex BP and BFV signals into multiple empirical modes, representing their instantaneous frequency-amplitude modulation. The empirical mode corresponding to the VM BP profile was used to construct the continuous phase diagram and to identify the minimum and maximum values from the residual BP (BPR) and BFV (BFVR) signals. The BP-BFV phase shift was calculated as the difference between the phase corresponding to the BPR and BFVR minimum (maximum) values. BP-BFV phase shifts were significantly different between groups. In the normotensive group, the BFVR minimum and maximum preceded the BPR minimum and maximum, respectively, leading to large positive values of BP-BFV shifts. In the stroke and hypertensive groups, the resulting BP-BFV phase shift was significantly smaller compared to the normotensive group. A standard autoregulation index did not differentiate the groups. The MMPF method enables evaluation of autoregulatory dynamics based on instantaneous BP-BFV phase analysis. Regulation of BP-BFV dynamics is altered with hypertension and after stroke, rendering blood flow dependent on blood pressure.

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