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Sample records for observational safety study

  1. Safety of Tdap vaccine in pregnant women: an observational study

    PubMed Central

    Petousis-Harris, Helen; Walls, Tony; Watson, Donna; Paynter, Janine; Graham, Patricia; Turner, Nikki

    2016-01-01

    Objectives Actively recruit and intensively follow pregnant women receiving a dose of acellular pertussis vaccine for 4 weeks after vaccination. Design and settings A prospective observational study conducted in 2 New Zealand regions. Participants Women in their 28th–38th week of pregnancy, recruited from primary care and antenatal clinics at the time of Tdap administration. Telephone interviews were conducted at 48 h and 4 weeks postvaccination. Main outcomes measures Outcomes were injection site reactions, systemic symptoms and serious adverse events (SAEs). Where available, data have been classified and reported according to Brighton Collaboration definitions. Results 793 women participated with 27.9% receiving trivalent inactivated influenza vaccine concomitantly. 79% of participants reported mild or moderate pain and 2.6% severe pain. Any swelling was reported by 7.6%, induration by 12.0% (collected from 1 site only, n=326), and erythema by 5.8% of participants. Fever was reported by 17 (2.1%) participants, 14 of these occurred within 24 h. Headache, dizziness, nausea, myalgia or arthralgia was reported by <4% of participants, respectively, and fatigue by 8.4%. During the study period, there were 115 adverse events in 113 participants, most of which were minor. At the end of the reporting period, 31 events were classified as serious (eg, obstetric bleeding, hypertension, infection, tachycardia, preterm labour, exacerbation of pre-existing condition and pre-eclampsia). All had variable onset time from vaccination. There were two perinatal deaths. Clinician assessment of all SAEs found none likely to be vaccine related. Conclusions Vaccination with Tdap in pregnant women was well tolerated with no SAE likely to be caused by the vaccine. Trial registration number ACTRN12613001045707. PMID:27091823

  2. The importance of confounding in observational before-and-after studies of road safety measures.

    PubMed

    Elvik, Rune

    2002-09-01

    This paper discusses the importance of confounding in observational before-and-after studies of road safety measures. The importance of the approach taken to controlling for confounding factors is shown by means of examples. It is shown that the size of the effect on accidents attributed to a road safety measure can be profoundly affected by which confounding factors are controlled for in an evaluation study, and the way this is done. Simple before-and-after studies, not controlling for any confounding factors should never be trusted and are likely to overstate the effects of road safety measures. PMID:12214957

  3. Effectiveness and safety of natalizumab in real-world clinical practice: Review of observational studies.

    PubMed

    van Pesch, Vincent; Sindic, Christian J; Fernández, Oscar

    2016-10-01

    Clinical trials have shown that natalizumab is highly effective for treating relapsing forms of multiple sclerosis (MS). The purpose of this analysis was to conduct a targeted review of data from country-specific observational studies and registries of natalizumab-treated patients with relapsing MS in order to more fully investigate the longer-term effectiveness and safety of this disease-modifying therapy in real-world clinical practice settings. A PubMed search was conducted on March 13, 2014, using the terms (natalizumab AND multiple sclerosis) AND (observational OR registry OR post-marketing OR clinical practice). Only English-language papers that reported effectiveness (in terms of effects on relapses, disability progression, and magnetic resonance imaging findings) and/or safety results from studies were included. Data from 22 studies/registries were included. Annualized relapse rates decreased by 73%-94% from baseline across the studies, with improvement maintained for up to 5 years during natalizumab treatment. Natalizumab effectiveness was also demonstrated via assessment of disability progression (Expanded Disability Status Scale), radiological measures, and no-evidence-of-disease-activity measures (clinical, radiological, and overall). Results were similar among patient groups stratified by level of disease activity. Safety outcomes were consistent with natalizumab's known safety profile. Data from country-specific observational studies and registries varying in size and scope support the effectiveness and safety of natalizumab in a broad range of patients in clinical practice. PMID:27475049

  4. Learning from positively deviant wards to improve patient safety: an observational study protocol

    PubMed Central

    Baxter, Ruth; Taylor, Natalie; Kellar, Ian; Lawton, Rebecca

    2015-01-01

    Introduction Positive deviance is an asset-based approach to improvement which has recently been adopted to improve quality and safety within healthcare. The approach assumes that solutions to problems already exist within communities. Certain groups or individuals identify these solutions and succeed despite having the same resources as others. Within healthcare, positive deviance has previously been applied at individual or organisational levels to improve specific clinical outcomes or processes of care. This study explores whether the positive deviance approach can be applied to multidisciplinary ward teams to address the broad issue of patient safety among elderly patients. Methods and analysis Preliminary work analysed National Health Service (NHS) Safety Thermometer data from 34 elderly medical wards to identify 5 ‘positively deviant’ and 5 matched ‘comparison’ wards. Researchers are blinded to ward status. This protocol describes a multimethod, observational study which will (1) assess the concurrent validity of identifying positively deviant elderly medical wards using NHS Safety Thermometer data and (2) generate hypotheses about how positively deviant wards succeed. Patient and staff perceptions of safety will be assessed on each ward using validated surveys. Correlation and ranking analyses will explore whether this survey data aligns with the routinely collected NHS Safety Thermometer data. Staff focus groups and researcher fieldwork diaries will be completed and qualitative thematic content analysis will be used to generate hypotheses about the strategies, behaviours, team cultures and dynamics that facilitate the delivery of safe patient care. The acceptability and sustainability of strategies identified will also be explored. Ethics and dissemination The South East Scotland Research Ethics Committee 01 approved this study (reference: 14/SS/1085) and NHS Permissions were granted from all trusts. Findings will be published in peer

  5. Efficacy and safety of moxifloxacin in community acquired pneumonia: a prospective, multicenter, observational study (CAPRIVI)

    PubMed Central

    2014-01-01

    Background Community acquired pneumonia (CAP) is a major cause of morbidity, hospitalization, and mortality worldwide. Management of CAP for many patients requires rapid initiation of empirical antibiotic treatment, based on the spectrum of activity of available antimicrobial agents and evidence on local antibiotic resistance. Few data exist on the severity profile and treatment of hospitalized CAP patients in Eastern and Central Europe and the Middle East, in particular on use of moxifloxacin (Avelox®), which is approved in these regions. Methods CAPRIVI (Community Acquired Pneumonia: tReatment wIth AVelox® in hospItalized patients) was a prospective observational study in 12 countries: Croatia, France, Hungary, Kazakhstan, Jordan, Kyrgyzstan, Lebanon, Republic of Moldova, Romania, Russia, Ukraine, and Macedonia. Patients aged >18 years were treated with moxifloxacin 400 mg daily following hospitalization with a CAP diagnosis. In addition to efficacy and safety outcomes, data were collected on patient history and disease severity measured by CRB-65 score. Results 2733 patients were enrolled. A low severity index (i.e., CRB-65 score <2) was reported in 87.5% of CAP patients assessed (n = 1847), an unexpectedly high proportion for hospitalized patients. Moxifloxacin administered for a mean of 10.0 days (range: 2.0 to 39.0 days) was highly effective: 96.7% of patients in the efficacy population (n = 2152) improved and 93.2% were cured of infection during the study. Severity of infection changed from “moderate” or “severe” in 91.8% of patients at baseline to “no infection” or “mild” in 95.5% at last visit. In the safety population (n = 2595), 127 (4.9%) patients had treatment-emergent adverse events (TEAEs) and 40 (1.54%) patients had serious TEAEs; none of these 40 patients died. The safety results were consistent with the known profile of moxifloxacin. Conclusions The efficacy and safety profiles of moxifloxacin at the recommended

  6. Safety and Effectiveness of Vibration Massage by Deep Oscillations: A Prospective Observational Study

    PubMed Central

    Kraft, Karin; Kanter, Susanne; Janik, Hubert

    2013-01-01

    The objective of this study is to assess the safety of treatment with vibration massage using a deep oscillation device and the effects on symptom severity and quality of life in patients with primary fibromyalgia syndrome (FMS). Outpatients with FMS performed an observational prospective study with visits 2–4 weeks after the last treatment (control) and after further 2 months (follow-up). Patients were treated with 10 sessions of 45 min deep oscillation massage, 2/week. Primary outcome parameters were safety and tolerability (5-level Likert scale (1 = very good)) (after each treatment session and at control visit). Secondary outcome parameters were symptom severity (Fibromyalgia Impact Questionnaire (FIQ), pain) and quality of life (SF-36). Seventy patients (97.1% females) were included. At control visit, 41 patients (58.6%) reported 63 mild and short-lasting adverse events, mainly worsening of prevalent symptoms such as pain and fatigue. Tolerability was rated as 1.8 (95% confidence interval: 1.53; 2.07). Symptoms and quality of life were significantly improved at both control and follow-up visits (at least P < 0.01). In conclusion, deep oscillation massage is safe and well tolerated in patients with FMS and might improve symptoms and quality of life rather sustained. PMID:24222779

  7. Bicyclist Safety Behaviors in an Urban Northeastern, United States City: An Observational Study.

    PubMed

    Wolfe, Elizabeth Suzanne; Arabian, Sandra Strack; Salzler, Matthew J; Bugaev, Nikolay; Rabinovici, Reuven

    2016-01-01

    Bicycling is gaining popularity in the United States, and laws and safety recommendations are being established to keep bicyclists safer. To improve road safety for bicyclists, there is a need to characterize their compliance with road laws and safety behaviors. Adult bicyclists were observed at three high-traffic intersections in Boston, MA, with state recommendations of wearing a helmet and riding in a bike lane. State law compliance for displaying reflectors during the day and of a front light and a rear light/reflector at night, obeying traffic signals, and giving pedestrians the right of way was also observed. Variables were compared between personal and shared/rented bicyclists and analyzed by time of day. A total of 1,685 bicyclists were observed. Because of the speed of the bicyclists and obstructed views, only a sampling of 802 bicyclists was observed for reflectors/front light. Overall, 74% wore a helmet, 49% had reflectors/front lights, 95% rode in bike lanes, 87% obeyed traffic signals, and 99% gave the right of way to pedestrians. Compared with shared bicyclists (n = 122), personal bicyclists (n = 1563) had a higher helmet-wearing behaviors (77% vs. 39%, p = .0001). Shared bicyclists had a higher (p = .0001) compliance with reflectors/lights (100%) than personal bicyclists (39%, n = 265). Boston bicyclists ride in bike lanes, obey traffic signals, give pedestrians the right of way, and wear helmets while having suboptimal compliance with light/reflector use. Educational programs and stricter law enforcement aimed at these safety behaviors should be part of the effort to improve safety for all road users. PMID:27163219

  8. Safety of pertussis vaccination in pregnant women in UK: observational study

    PubMed Central

    King, Bridget; Bryan, Phil

    2014-01-01

    Objective To examine the safety of pertussis vaccination in pregnancy. Design Observational cohort study. Setting The UK Clinical Practice Research Datalink. Participants 20 074 pregnant women with a median age of 30 who received the pertussis vaccine and a matched historical unvaccinated control group. Main outcome measure Adverse events identified from clinical diagnoses during pregnancy, with additional data from the matched child record identified through mother-child linkage. The primary event of interest was stillbirth (intrauterine death after 24 weeks’ gestation). Results There was no evidence of an increased risk of stillbirth in the 14 days immediately after vaccination (incidence rate ratio 0.69, 95% confidence interval 0.23 to 1.62) or later in pregnancy (0.85, 0.44 to 1.61) compared with historical national rates. Compared with a matched historical cohort of unvaccinated pregnant women, there was no evidence that vaccination accelerated the time to delivery (hazard ratio 1.00, 0.97 to 1.02). Furthermore, there was no evidence of an increased risk of stillbirth, maternal or neonatal death, pre-eclampsia or eclampsia, haemorrhage, fetal distress, uterine rupture, placenta or vasa praevia, caesarean delivery, low birth weight, or neonatal renal failure, all serious events that can occur naturally in pregnancy. Conclusion In women given pertussis vaccination in the third trimester, there is no evidence of an increased risk of any of an extensive predefined list of adverse events related to pregnancy. In particular, there was no evidence of an increased risk of stillbirth. Given the recent increases in the rate of pertussis infection and morbidity and mortality in neonates, these early data provide initial evidence for evaluating the safety of the vaccine in pregnancy for health professionals and the public and can help to inform vaccination policy making. PMID:25015137

  9. Safety of Intravenous Application of Mistletoe (Viscum album L.) Preparations in Oncology: An Observational Study.

    PubMed

    Steele, Megan L; Axtner, Jan; Happe, Antje; Kröz, Matthias; Matthes, Harald; Schad, Friedemann

    2014-01-01

    Background. Traditional mistletoe therapy in cancer patients involves subcutaneous applications of Viscum album L. preparations, with doses slowly increasing based on patient responses. Intravenous infusion of high doses may improve therapeutic outcomes and is becoming more common. Little is known about the safety of this "off-label" application of mistletoe. Methods. An observational study was performed within the Network Oncology. Treatment with intravenous mistletoe applications is described. The frequency of adverse drug reactions (ADRs) to intravenous mistletoe applications was calculated and compared to ADR data from a study on subcutaneous applications. Results. Of 475 cancer patients who received intravenous infusions of Helixor, Abnoba viscum, or Iscador mistletoe preparations, 22 patients (4.6%) reported 32 ADRs of mild (59.4%) or moderate severity (40.6%). No serious ADRs occurred. ADRs were more frequently reported to i.v. mistletoe administered alone (4.3%), versus prior to chemotherapy (1.6%). ADR frequency differed with respect to preparation type, with Iscador preparations showing a higher relative frequency, compared to Abnoba viscum and Helixor. Overall, patients were almost two times less likely to experience an ADR to intravenous compared to subcutaneous application of mistletoe. Conclusion. Intravenous mistletoe therapy was found to be safe and prospective studies for efficacy are recommended. PMID:24955100

  10. Safety of Intravenous Application of Mistletoe (Viscum album L.) Preparations in Oncology: An Observational Study

    PubMed Central

    Steele, Megan L.; Axtner, Jan; Happe, Antje; Kröz, Matthias; Matthes, Harald; Schad, Friedemann

    2014-01-01

    Background. Traditional mistletoe therapy in cancer patients involves subcutaneous applications of Viscum album L. preparations, with doses slowly increasing based on patient responses. Intravenous infusion of high doses may improve therapeutic outcomes and is becoming more common. Little is known about the safety of this “off-label” application of mistletoe. Methods. An observational study was performed within the Network Oncology. Treatment with intravenous mistletoe applications is described. The frequency of adverse drug reactions (ADRs) to intravenous mistletoe applications was calculated and compared to ADR data from a study on subcutaneous applications. Results. Of 475 cancer patients who received intravenous infusions of Helixor, Abnoba viscum, or Iscador mistletoe preparations, 22 patients (4.6%) reported 32 ADRs of mild (59.4%) or moderate severity (40.6%). No serious ADRs occurred. ADRs were more frequently reported to i.v. mistletoe administered alone (4.3%), versus prior to chemotherapy (1.6%). ADR frequency differed with respect to preparation type, with Iscador preparations showing a higher relative frequency, compared to Abnoba viscum and Helixor. Overall, patients were almost two times less likely to experience an ADR to intravenous compared to subcutaneous application of mistletoe. Conclusion. Intravenous mistletoe therapy was found to be safe and prospective studies for efficacy are recommended. PMID:24955100

  11. Safety Observations Achieve Results

    Energy Science and Technology Software Center (ESTSC)

    2000-01-16

    The SOAR web application provides a multi-checklist capability where focused observations can be created to address risk-likely work environments, tasks, etc. The SOAR web application has numerous reports to sort the data by key word, multiple factors (i.e., location, team, behavior, checklist, work environment, etc.), and the highest frequency of behaviors and error-likely predecessors, etc. Other performance indicators are also provided.

  12. The Effects of Safety Discrimination Training and Frequent Safety Observations on Safety-Related Behavior

    ERIC Educational Resources Information Center

    Taylor, Matthew A.; Alvero, Alicia M.

    2012-01-01

    The intent of the present study was to assess the effects of discrimination training only and in combination with frequent safety observations on five participants' safety-related behavior in a simulated office setting. The study used a multiple-baseline design across safety-related behaviors. Across all participants and behavior, safety improved…

  13. Improving patient safety during insertion of peripheral venous catheters: an observational intervention study

    PubMed Central

    Kampf, Günter; Reise, Gesche; James, Claudia; Gittelbauer, Kirsten; Gosch, Jutta; Alpers, Birgit

    2013-01-01

    Background: Peripheral venous catheters are frequently used in hospitalized patients but increase the risk of nosocomial bloodstream infection. Evidence-based guidelines describe specific steps that are known to reduce infection risk. However, the degree of guideline implementation in clinical practice is not known. The aim of this study was to determine the use of specific steps for insertion of peripheral venous catheters in clinical practice and to implement a multimodal intervention aimed at improving both compliance and the optimum order of the steps. Methods: The study was conducted at University Hospital Hamburg. An optimum procedure for inserting a peripheral venous catheter was defined based on three evidence-based guidelines (WHO, CDC, RKI) including five steps with 1A or 1B level of evidence: hand disinfection before patient contact, skin antisepsis of the puncture site, no palpation of treated puncture site, hand disinfection before aseptic procedure, and sterile dressing on the puncture site. A research nurse observed and recorded procedures for peripheral venous catheter insertion for healthcare workers in four different departments (endoscopy, central emergency admissions, pediatrics, and dermatology). A multimodal intervention with 5 elements was established (teaching session, dummy training, e-learning tool, tablet and poster, and direct feedback), followed by a second observation period. During the last observation week, participants evaluated the intervention. Results: In the control period, 207 insertions were observed, and 202 in the intervention period. Compliance improved significantly for four of five steps (e.g., from 11.6% to 57.9% for hand disinfection before patient contact; p<0.001, chi-square test). Compliance with skin antisepsis of the puncture site was high before and after intervention (99.5% before and 99.0% after). Performance of specific steps in the correct order also improved (e.g., from 7.7% to 68.6% when three of five steps

  14. Safety of artemisinins in first trimester of prospectively followed pregnancies: an observational study

    PubMed Central

    Moore, Kerryn A; Simpson, Julie A; Paw, Moo Kho; Pimanpanarak, MuPawJay; Wiladphaingern, Jacher; Rijken, Marcus J; Jittamala, Podjanee; White, Nicholas J; Fowkes, Freya J I; Nosten, François; McGready, Rose

    2016-01-01

    Summary Background Artemisinins, the most effective antimalarials available, are not recommended for falciparum malaria during the first trimester of pregnancy because of safety concerns. Therefore, quinine is used despite its poor effectiveness. Assessing artemisinin safety requires weighing the risks of malaria and its treatment. We aimed to assess the effect of first-trimester malaria and artemisinin treatment on miscarriage and major congenital malformations. Methods In this observational study, we assessed data from antenatal clinics on the Thai–Myanmar border between Jan 1, 1994, and Dec 31, 2013. We included women who presented to antenatal clinics during their first trimester with a viable fetus. Women were screened for malaria, and data on malaria, antimalarial treatment, and birth outcomes were collected. The relationship between artemisinin treatments (artesunate, dihydroartemisinin, or artemether) and miscarriage or malformation was assessed using Cox regression with left-truncation and time-varying exposures. Findings Of 55 636 pregnancies registered between 1994 and 2013, 25 485 pregnancies were analysed for first-trimester malaria and miscarriage, in which 2558 (10%) had first-trimester malaria. The hazard of miscarriage increased 1·61-fold after an initial first-trimester falciparum episode (95% CI 1·32–1·97; p<0·0001), 3·24-fold following falciparum recurrence (2·24–4·68; p<0·0001), and 2·44-fold (1·01–5·88; p=0·0473) following recurrent symptomatic vivax malaria. No difference was noted in miscarriage in first-line falciparum treatments with artemisinin (n=183) versus quinine (n=842; HR 0·78 [95% CI 0·45–1·34]; p=0·3645) or in risk of major congenital malformations (two [2%] of 109 [95% CI 0·22–6·47] versus eight (1%) of 641 [0·54–2·44], respectively). Interpretation First-trimester falciparum and vivax malaria both increase the risk of miscarriage. We noted no evidence of an increased risk of miscarriage or

  15. Safety and efficacy of dimethyl fumarate in multiple sclerosis: a multi-center observational study.

    PubMed

    Miclea, A; Leussink, V I; Hartung, H P; Gold, R; Hoepner, R

    2016-08-01

    Dimethyl fumarate (DMF) was recently approved for treating patients with relapsing-remitting multiple sclerosis (RRMS) based on two phase III clinical trials demonstrating its efficacy. This prompts the need for demonstrating the clinical efficacy and safety of DMF in the real world. By retrospective analysis of medical records at two German MS centers, 644 MS patients treated with DMF were identified. All were included in a safety analysis, and a subgroup of patients with available efficacy data during previous MS therapies (n = 352) was further analyzed for annualized relapse rate and disability progression assessed by the EDSS. In the overall DMF population studied, the annualized relapse rate decreased from 0.52 at baseline to 0.35, and the annualized disability progression from 0.15 to 0.10. Patients who were switched from interferons or glatiramer acetate to DMF revealed a greater benefit, whereas patients pretreated with more potent immunotherapies did not respond that well. Interestingly, patients with a lymphocyte count ≥2000/µl after 0.52 years (mean, SD 0.2) of DMF treatment did not benefit compared to those with lower lymphocyte counts. In total, 22.2 % of the patients withdrew from DMF due to side effects, with gastrointestinal discomfort (12.7 %) and lymphopenia (5.3 %) as most frequently reported reasons. Our study corroborates that DMF is an overall safe and effective drug that reduces relapse rate as well as disability progression in MS patients. Further prospective studies are warranted to establish the additional parameters predicting DMF response, especially in patients switching from other first-line immunotherapies. PMID:27260297

  16. Safety and efficacy of hysteroscopic sterilization compared with laparoscopic sterilization: an observational cohort study

    PubMed Central

    Mao, Jialin; Pfeifer, Samantha; Schlegel, Peter

    2015-01-01

    Objective To compare the safety and efficacy of hysteroscopic sterilization with the “Essure” device with laparoscopic sterilization in a large, all-inclusive, state cohort. Design Population based cohort study. Settings Outpatient interventional setting in New York State. Participants Women undergoing interval sterilization procedure, including hysteroscopic sterilization with Essure device and laparoscopic surgery, between 2005 and 2013. Main outcomes measures Safety events within 30 days of procedures; unintended pregnancies and reoperations within one year of procedures. Mixed model accounting for hospital clustering was used to compare 30 day and 1 year outcomes, adjusting for patient characteristics and other confounders. Time to reoperation was evaluated using frailty model for time to event analysis. Results We identified 8048 patients undergoing hysteroscopic sterilization and 44 278 undergoing laparoscopic sterilization between 2005 and 2013 in New York State. There was a significant increase in the use of hysteroscopic procedures during this period, while use of laparoscopic sterilization decreased. Patients undergoing hysteroscopic sterilization were older than those undergoing laparoscopic sterilization and were more likely to have a history of pelvic inflammatory disease (10.3% v 7.2%, P<0.01), major abdominal surgery (9.4% v 7.9%, P<0.01), and cesarean section (23.2% v 15.4%, P<0.01). At one year after surgery, hysteroscopic sterilization was not associated with a higher risk of unintended pregnancy (odds ratio 0.84 (95% CI 0.63 to 1.12)) but was associated with a substantially increased risk of reoperation (odds ratio 10.16 (7.47 to 13.81)) compared with laparoscopic sterilization. Conclusions Patients undergoing hysteroscopic sterilization have a similar risk of unintended pregnancy but a more than 10-fold higher risk of undergoing reoperation compared with patients undergoing laparoscopic sterilization. Benefits and risks of both procedures

  17. Safety and efficacy of calcium folinate in psoriasis: an observational study.

    PubMed

    Carlesimo, M; Mari, E; Arcese, A; De Angelis, F; Palese, E; Abruzzese, C; De Marco, G; Cattaruzza, M S; Camplone, G

    2010-01-01

    An association between psoriasis and cardiovascular diseases has been reported, and treatment of this condition is often considered difficult because the conventional systemic therapies often show several side effects. To assess the efficacy and tolerability of a new drug, folinate calcium, to treat psoriasis, a total of 58 patients affected by active psoriasis were enrolled in a variable period study. These patients had clinically stable, plaque psoriasis involving greater than or equal 6% body surface area. Thirty of these patients were treated with folinate calcium therapy, 15 mg orally once daily, for a variable period based on each patients clinical response. The comparison was made with 28 psoriatic patients treated with conventional systemic therapies (cyclosporine, acitretin, etanercept, efalizumab, infliximab, adalimumab). A clinical improvement was observed in both group, but in the first one we did not observe any side effects, whereas some important side effects were observed in the second. These preliminary results support the effectiveness and tolerability of folinate calcium treatment in psoriasis. PMID:20646362

  18. Efficacy and safety of oral triclofos as sedative for children undergoing sleep electroencephalogram: An observational study

    PubMed Central

    Jain, Puneet; Sharma, Suvasini; Sharma, Ankita; Goel, Shaiphali; Jose, Anjali; Aneja, Satinder

    2016-01-01

    Objectives: Triclofos may be a better sedative in view of better palatability and less gastric irritation as compared to chloral hydrate. This study aimed to assess the efficacy of triclofos (a commonly used sedative in India) as a sedative for sleep electroencephalogram (EEG) study in children. Methods: This prospective observational study was carried out in a tertiary care pediatric center. Consecutive children aged 6 months to 5 years referred for sleep EEG evaluation were recruited. Their clinical details were noted in a proforma after an informed consent. After a trial for natural sleep, oral triclofos was administered. Sleep parameters and adverse effects were noted. Results: One-hundred and sixty children were then enrolled. EEG was successfully recorded in 149 (93.1%) children. Median latency of sleep onset was 30 min and median duration of sleep was 90 min. The adverse effects in the following 24 h were mild and included dizziness, irritability, and vomiting. Conclusions: Oral triclofos was found to be an effective sedative for EEG in children with minimal adverse effects.

  19. Efficacy and safety of moxifloxacin in acute exacerbations of chronic bronchitis: a prospective, multicenter, observational study (AVANTI)

    PubMed Central

    2013-01-01

    Background Acute exacerbations of chronic bronchitis (AECB), including chronic obstructive pulmonary disease (AECOPD), represent a substantial patient burden. Few data exist on outpatient antibiotic management for AECB/AECOPD in Eastern/South Eastern Europe, in particular on the use of moxifloxacin (Avelox®), although moxifloxacin is widely approved in this region based on evidence from international clinical studies. Methods AVANTI (AVelox® in Acute Exacerbations of chroNic bronchiTIs) was a prospective, observational study conducted in eight Eastern European countries in patients > 35 years with AECB/AECOPD to whom moxifloxacin was prescribed. In addition to safety and efficacy outcomes, data on risk factors and the impact of exacerbation on daily life were collected. Results In the efficacy population (N = 2536), chronic bronchitis had been prevalent for > 10 years in 31.4% of patients and 66.0% of patients had concomitant COPD. Almost half the patients had never smoked, in contrast to data from Western Europe and the USA, where only one-quarter of COPD patients are non-smokers. The mean number of exacerbations in the last 12 months was 2.7 and 26.3% of patients had been hospitalized at least once for exacerbation. Physician compliance with the recommended moxifloxacin dose (400 mg once daily) was 99.6%. The mean duration of moxifloxacin therapy for the current exacerbation (Anthonisen type I or II in 83.1%; predominantly type I) was 6.4 ± 1.9 days. Symptom improvement was reported after a mean of 3.4 ± 1.4 days. After 5 days, 93.2% of patients reported improvement and, in total, 93.5% of patients were symptom-free after 10 days. In the safety population (N = 2672), 57 (2.3%) patients had treatment-emergent adverse events (TEAEs) and 4 (0.15%) had serious TEAEs; no deaths occurred. These results are in line with the known safety profile of moxifloxacin. Conclusions A significant number of patients in this observational study had risk

  20. The ethics of postmarketing observational studies of drug safety under section 505(o)(3) of the Food, Drug, and Cosmetic Act.

    PubMed

    Evans, Barbara J

    2012-01-01

    In 2007, Congress granted the Food and Drug Administration (FDA) new powers to order pharmaceutical companies to conduct drug safety studies and clinical trials in the postmarketing period after drugs are approved The methodologies include observational studies that examine patients' insurance claims data and clinical records to infer whether drugs are safe in actual clinical practice. Such studies offer a valuable tool for improving drug safety, but they raise ethical and privacy concerns because they would entail widespread use of patients' health information in commercial research by drug manufacturers. This is the first article to explore the ethics of these section 505(0)(3) observational studies, so named after the section of the Food, Drug, and Cosmetic Act that authorizes them. Data access problems threaten to make the FDA's section 505(0)(3) study requirements unenforceable. Under existing federal privacy regulations, it appears highly unlikely that pharmaceutical companies will have reliable access to crucial data resources, such as insurance claims data and healthcare records, to use in these studies. State privacy laws present another potential barrier to data access. If pharmaceutical companies do manage to gain access to the needed data, this will raise serious privacy concerns because section 505(0)(3) observational studies do not appear to be covered by any of the major federal regulations that afford ethical and privacy protections to persons whose data are used in research. If the FDA's program of section 505(o)(3) observational studies fails because of the above problems, this failure will have a number of bad consequences: the public will be exposed to avoidable drug safety risks; taxpayers may be forced to bear the costs of having the FDA conduct drug safety investigations that would have been funded by drug manufacturers if data had been available; and, perhaps most troubling, the FDA may be forced to order postmarketing clinical trials to

  1. Safety and efficacy of donepezil hydrochloride in patients with mild to moderate Alzheimer's disease: Findings of an observational study

    PubMed Central

    Mehta, Suyog; Chandersekhar, K.; Prasadrao, G.; Dutt, Lakshman; Patkar, S.; Nagpal, R. D.; Gupta, M.; Raju, G. S. P.; Praveen, K. K.; Prasad, B. S. V.; Roy, T.; Kushwaha, S.; Nag, Jyotindra; Langade, D.; Pawar, D.

    2012-01-01

    Background: Alzheimer's disease (AD), a progressive brain disorder, is the most common cause of dementia among the elderly. Donepezil hydrochloride is a potent, reversible, and highly selective inhibitor of acetylcholinesterase (AChE). It is chemically distinct from other cholinesterase (ChE) inhibitors which are effective in the treatment of AD. Objectives: To evaluate the safety and efficacy of donepezil hydrochloride therapy over a 12 weeks period in patients with mild to moderate AD in Indian population. Materials and Methods: In this post-marketing study, patients with mild to moderate AD received oral donepezil hydrochloride 5 mg/day for 4 weeks followed by 10 mg/day for 8 weeks. Patients were assessed 4 times weekly for cognition on ‘Mini Mental Status Examination (MMSE) scale’, and function on ‘Activities of Daily Living (ADL) index’. Clinicians and caregivers assessment of safety and efficacy was assessed on a 5-point rating scale. Results: One hundred and seventy two of one hundred and eighty two patients completed 12 weeks of study period. MMSE score significantly improved (P<0.0001) from 16.72 at baseline to 19.77 after 12 weeks, and there was significant improvement (P<0.05) in ADL index in 13 of 17 domains after 12 weeks. Caregivers and clinicians rated the therapy as very good to good in >80% and >90% patients, respectively. Adverse events were consistent with the known pharmacological and safety profile of donepezil. Conclusions: Donepezil is well tolerated in Indian patients with mild to moderate AD with significant improvement in cognition and function. PMID:23372236

  2. Observational postmarketing study on efficacy and safety of novel generic risperidone risset(r) in patients with acute or chronic schizophrenic or other related psychosis.

    PubMed

    Kucukalić, Abdulah; Srkalović, Azijada Pasicek; Oremus, Marijana; Rustempasić, Edhem

    2004-06-01

    Objective. The aim of this study was to establish the effectiveness and safety of risperidone (Risset(R) - PLIVA) in patients with acute or chronic schizophrenic or other related psychosis. Study was designed as postmarketing, 4-week, open-label, flexible-dose observational study. Subjects and Methods. 30 patients, both genders, aged 18-70 years, with diagnosed various types of schizophrenic psychosis were enrolled in the study as outpatient and inpatient setting. The patients had to have a total score >/=40 on Positive and Negative scale - two parts of the Positive and Negative Syndrome Scale (PANSS), and to be able to discontinue current antipsychotic and antiparkinsonian medications. The primary efficacy parameter was the percent of score difference between baseline and week 4 of therapy on two above-mentioned PANSS subscales. The difference was considered as significant improvement if decrease from the baseline was 20% or more. The safety of risperidone was evaluated on the basis of reported adverse events. Results. All 30 enrolled patients completed the study. After the 4 weeks of treatment, 23/30 patients (76.67%) had clinically significant improvement of 20% or more decreased total PANSS score (Positive and Negative subscale). In 4/30 patients (13.33%) clinical improvement was also reported with <20% decreased total PANSS score. No serious adverse event was observed. Conclusions. Overall, collected data indicate that in this specific population (70% patients were resistant to previous anti-psychotic therapy), Risset(R) has shown very good effectiveness and safety. PMID:19114946

  3. Mars Observer: Phase 0 safety review data package

    NASA Technical Reports Server (NTRS)

    1986-01-01

    The Mars Observer Program has as its primary objectives a study of the geochemistry, atmospheric dynamics, atmosphere/surface interactions, seasonal variations, and magnetic field characteristics of Mars. The Mars Observer Spacecraft, safety critical spacecraft subsystems, ground support equipment, ground operations scenario, requirements matrix, and equipment specifications are described.

  4. Safety of pramlintide added to mealtime insulin in patients with type 1 or type 2 diabetes: a large observational study.

    PubMed

    Pencek, R; Roddy, T; Peters, Y; De Young, M B; Herrmann, K; Meller, L; Nguyen, H; Chen, S; Lutz, K

    2010-06-01

    The objective of this Phase 4, open-label, multicentre, observational study was to fulfil food and drug administration (FDA) postapproval requirement to evaluate in healthcare practices the risk of insulin-induced severe hypoglycaemia following initiation of pramlintide therapy in N = 1297 patients with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) with inadequate glycaemic control. The duration of the study was approximately 6 months. During the adjustment period (0-3 months), the incidence and event rate of patient-ascertained severe hypoglycaemia (PASH) were 4.8% and 0.33 events/patient-year in patients with T1DM and 2.8% and 0.19 events/patient-year in patients with T2DM. During the maintenance period (>3-6 months), the incidence and event rate of PASH declined in patients with T1DM or T2DM. This study confirms that in healthcare practices, the risk of insulin-induced severe hypoglycaemia following the initiation of pramlintide is low in patients with T1DM or T2DM. PMID:20518811

  5. Evaluation of safety and efficacy of zonisamide in adult patients with partial, generalized, and combined seizures: an open labeled, noncomparative, observational Indian study.

    PubMed

    Dash, Amitabh; Ravat, Sangeeta; Srinivasan, Avathvadi Venkatesan; Shetty, Ashutosh; Kumar, Vivek; Achtani, Renu; Mathur, Vivek Narain; Maramattom, Boby Varkey; Bajpai, Veeresh; Manjunath, Nanjappa C; Narayana, Randhi Venkata; Mehta, Suyog

    2016-01-01

    A prospective, multicentric, noncomparative open-label observational study was conducted to evaluate the safety and efficacy zonisamide in Indian adult patients for the treatment of partial, generalized, or combined seizures. A total of 655 adult patients with partial, generalized, or combined seizures from 30 centers across India were recruited after initial screening. Patients received 100 mg zonisamide as initiating dose as monotherapy/adjunctive therapy for 24 weeks, with titration of 100 mg every 2 weeks if required. Adverse events, responder rates, and seizure freedom were observed every 4 weeks. Efficacy and safety were also assessed using Clinicians Global Assessment of Response to Therapy and Patients Global Assessment of Tolerability to Therapy, respectively. Follow-up was conducted for a period of 24 weeks after treatment initiation. A total of 655 patients were enrolled and received the treatment and 563 completed the evaluation phase. A total of 20.92% of patients received zonisamide as monotherapy or alternative monotherapy and 59.85% patients received zonisamide as first adjunctive therapy. Compared with baseline, 41.22% of patients achieved seizure freedom and 78.6% as responder rate at the end of 24 week study. Most commonly reported adverse events were loss of appetite, weight loss, sedation, and dizziness, but discontinuation due to adverse events of drug was seen in 0.92% of patients. This open label real-world study suggests that zonisamide is an effective and well-tolerated antiepileptic drug in Indian adults for treatment of partial, generalized as well as combined seizures type. No new safety signals were observed. PMID:27013882

  6. Evaluation of safety and efficacy of zonisamide in adult patients with partial, generalized, and combined seizures: an open labeled, noncomparative, observational Indian study

    PubMed Central

    Dash, Amitabh; Ravat, Sangeeta; Srinivasan, Avathvadi Venkatesan; Shetty, Ashutosh; Kumar, Vivek; Achtani, Renu; Mathur, Vivek Narain; Maramattom, Boby Varkey; Bajpai, Veeresh; Manjunath, Nanjappa C; Narayana, Randhi Venkata; Mehta, Suyog

    2016-01-01

    A prospective, multicentric, noncomparative open-label observational study was conducted to evaluate the safety and efficacy zonisamide in Indian adult patients for the treatment of partial, generalized, or combined seizures. A total of 655 adult patients with partial, generalized, or combined seizures from 30 centers across India were recruited after initial screening. Patients received 100 mg zonisamide as initiating dose as monotherapy/adjunctive therapy for 24 weeks, with titration of 100 mg every 2 weeks if required. Adverse events, responder rates, and seizure freedom were observed every 4 weeks. Efficacy and safety were also assessed using Clinicians Global Assessment of Response to Therapy and Patients Global Assessment of Tolerability to Therapy, respectively. Follow-up was conducted for a period of 24 weeks after treatment initiation. A total of 655 patients were enrolled and received the treatment and 563 completed the evaluation phase. A total of 20.92% of patients received zonisamide as monotherapy or alternative monotherapy and 59.85% patients received zonisamide as first adjunctive therapy. Compared with baseline, 41.22% of patients achieved seizure freedom and 78.6% as responder rate at the end of 24 week study. Most commonly reported adverse events were loss of appetite, weight loss, sedation, and dizziness, but discontinuation due to adverse events of drug was seen in 0.92% of patients. This open label real-world study suggests that zonisamide is an effective and well-tolerated antiepileptic drug in Indian adults for treatment of partial, generalized as well as combined seizures type. No new safety signals were observed. PMID:27013882

  7. A prospective observational study to evaluate safety reporting of antidepressants at a tertiary care hospital in India

    PubMed Central

    Lucca, Jisha M.; Madhan, Ramesh; Gurumurthy, Parthasarathi; Dushad, Ram

    2014-01-01

    Objective: This prospective observational study was carried out to identify the prevalence and Severity of ADRs of antidepressant in a tertiary care teaching hospital. Materials and Methods: Patients prescribed with at least one antidepressant were randomly selected and monitored for adverse drug reactions (ADRs), irrespective of their age and gender. Results: Of the 401 patients who received antidepressants, 170 patients (42.39%) experienced 204 ADRs. Selective serotonin receptor inhibitors (SSRIs) [110 (53.92)] was the most common therapeutic class of drugs associated with ADRs. Gastrointestinal system [54 (26.47)] was most commonly affected system organ class. Dry mouth (n = 30) and diaphoresis (n = 21) were the most frequently reported ADRs. As assessed by the World Health organization (WHO) probability scale, 61% of the ADRs were ‘probable’ causality. Among all the ADRs, 22.54% (46) were preventable. Majority of the ADRs [(n = 184) 90.17%] were ‘mild’ in their severity. Conclusion: In this study, incidence of adverse reaction to antidepressants was 42.3% were the most comman SSRI inplicated drug group for the ADRs. PMID:25298586

  8. WIN OVER study: Efficacy and safety of olmesartan in Indian hypertensive patients: Results of an open label, non-comparative, multi-centric, post marketing observational study

    PubMed Central

    Kumbla, D.K.; Kumar, S.; Reddy, Y.V.; Trailokya, A.; Naik, M.

    2014-01-01

    Background Hypertension is a global health problem. Multiple classes of drugs including angiotensin receptor blockers (ARBs) are available for the treatment of hypertension. Olmesartan is a relatively newer ARB used in hypertension management. Objective To assess the efficacy and safety of WIN-BP (Olmesartan 20 mg/40 mg) tablet in Indian patients with hypertension. Material and methods An open label, non-comparative, multi-centric, real world post marketing observational study included Indian adult hypertensive patients who were treated with olmesartan 20 mg/40 mg tablet once daily for six months. The primary outcome was reduction of systolic blood pressure (SBP) to <140 mmHg and diastolic BP (DBP) to <90 mmHg at 3 and 6 months after initiation of treatment with olmesartan. All reported adverse events were recorded. Results A total of 8940 patients were enrolled in this study. Baseline SBP of 164 mmHg was reduced to 153, 145, 134 and 130 mmHg at the end of 15 days, 1, 3 and 6 months respectively. Similarly, baseline DBP of 100 mmHg was reduced to 93, 89, 84 and 82 mmHg at the end of 15 days, 1, 3 and 6 months respectively. The reduction in both systolic and diastolic blood pressure from day 15 to month 6 was statistically significant (p < 0.0001) with olmesartan treatment. The percentage of responders for both systolic and diastolic blood pressure increased consistently from day 15 to month 6. Only 0.08% patients reported the adverse events. No serious adverse event was reported in the study. Conclusion Olmesartan 20 mg/40 mg is effective and well tolerated without any serious adverse events in patients with hypertension. PMID:24973841

  9. Efficacy and Safety of Intravenous Ferric Carboxymaltose in Geriatric Inpatients at a German Tertiary University Teaching Hospital: A Retrospective Observational Cohort Study of Clinical Practice.

    PubMed

    Bach, Matthias; Geisel, Tabea; Martin, Julia; Schulze, Bettina; Schaefer, Roland; Virgin, Garth; Stein, Juergen

    2015-01-01

    Current iron supplementation practice in geriatric patients is erratic and lacks evidence-based recommendations. Despite potential benefits in this population, intravenous iron supplementation is often withheld due to concerns regarding pharmacy expense, perceived safety issues, and doubts regarding efficacy in elderly patients. This retrospective, observational cohort study aimed to evaluate the safety and efficacy of intravenous ferric carboxymaltose (FCM, Ferinject) in patients aged >75 years with iron deficiency anaemia (IDA). Within a twelve-month data extraction period, the charts of 405 hospitalised patients aged 65-101 years were retrospectively analysed for IDA, defined according to WHO criteria for anaemia (haemoglobin: <13.0 g/dL (m)/<12.0 g/dL (f)) in conjunction with transferrin saturation <20%. Of 128 IDA patients screened, 51 (39.8%) received intravenous iron. 38 patient charts were analysed. Mean cumulative dose of intravenous FCM was 784.4 ± 271.7 mg iron (1-3 infusions). 18 patients (47%) fulfilled treatment response criteria (≥1.0 g/dL increase in haemoglobin between baseline and hospital discharge). AEs were mild/moderate, most commonly transient increases of liver enzymes (n = 5/13.2%). AE incidence was comparable with that observed in patients <75 years. No serious AEs were observed. Ferric carboxymaltose was well tolerated and effective for correction of Hb levels and iron stores in this cohort of IDA patients aged over 75 years. PMID:26236500

  10. Efficacy and Safety of Intravenous Ferric Carboxymaltose in Geriatric Inpatients at a German Tertiary University Teaching Hospital: A Retrospective Observational Cohort Study of Clinical Practice

    PubMed Central

    Bach, Matthias; Geisel, Tabea; Martin, Julia; Schulze, Bettina; Schaefer, Roland; Virgin, Garth; Stein, Juergen

    2015-01-01

    Current iron supplementation practice in geriatric patients is erratic and lacks evidence-based recommendations. Despite potential benefits in this population, intravenous iron supplementation is often withheld due to concerns regarding pharmacy expense, perceived safety issues, and doubts regarding efficacy in elderly patients. This retrospective, observational cohort study aimed to evaluate the safety and efficacy of intravenous ferric carboxymaltose (FCM, Ferinject) in patients aged >75 years with iron deficiency anaemia (IDA). Within a twelve-month data extraction period, the charts of 405 hospitalised patients aged 65–101 years were retrospectively analysed for IDA, defined according to WHO criteria for anaemia (haemoglobin: <13.0 g/dL (m)/<12.0 g/dL (f)) in conjunction with transferrin saturation <20%. Of 128 IDA patients screened, 51 (39.8%) received intravenous iron. 38 patient charts were analysed. Mean cumulative dose of intravenous FCM was 784.4 ± 271.7 mg iron (1–3 infusions). 18 patients (47%) fulfilled treatment response criteria (≥1.0 g/dL increase in haemoglobin between baseline and hospital discharge). AEs were mild/moderate, most commonly transient increases of liver enzymes (n = 5/13.2%). AE incidence was comparable with that observed in patients <75 years. No serious AEs were observed. Ferric carboxymaltose was well tolerated and effective for correction of Hb levels and iron stores in this cohort of IDA patients aged over 75 years. PMID:26236500

  11. Observational studies in South African mines to mitigate seismic risks: implications for mine safety and tectonic earthquakes

    NASA Astrophysics Data System (ADS)

    Durrheim, Raymond; Ogaswara, Hiroshi; Nakatani, Masao; Yabe, Yasuo; Milev, Alexander; Cichowicz, Artur; Kawakata, Hironori; Moriya, Hirokazu; Naoi, Makoto; Kgarume, Thabang; Murakami, Osamu; Mngadi, Siyanda

    2014-05-01

    Seismicity poses a significant risk to workers in deep and overstressed mines, such as the gold mines in the Witwatersrand basin of South Africa, as well as inhabitants of earthquake-prone regions such as Japan. A 5-year collaborative project entitled "Observational studies in South African mines to mitigate seismic risks" was launched in 2010 to address these risks, drawing on over a century of South African and Japanese research experience with respect to mining-related and tectonic earthquakes, respectively. The project has three main aims: (1) to learn more about earthquake preparation and triggering mechanisms by deploying arrays of sensitive sensors within rock volumes where mining is likely to induce seismic activity; (2) to learn more about earthquake rupture and rockburst damage phenomena by deploying robust strong ground motion sensors close to potential fault zones and on stope hangingwalls; and (3) to upgrade the South African surface national seismic network in the mining districts. Research sites have been established at mines operated by Sibanye Gold (Hlanganani Shaft and Cooke #4 Shaft) and Anglogold Ashanti (Moab-Khotsong). More than 70 boreholes (totalling more than 2.8 km in length) have been drilled to locate "capable" faults i.e. faults that are considered likely to become seismically active as a result of mining activity and to deploy sensors. Acoustic emission sensors, strain- and tilt meters, and controlled seismic sources were installed to monitor the deformation of the rock mass, the accumulation of damage during the earthquake preparation phase, and changes in dynamic stress produced by the propagation of the rupture front. These data are being integrated with measurements of rock properties, stope closure, stope strong motion, seismic data recorded by the mine-wide network, and stress modelling. The mid-point of the 5-year project has passed. New observations of stress and the response of the rock mass to mining have already been made

  12. Facility safety study

    NASA Technical Reports Server (NTRS)

    1979-01-01

    The safety of NASA's in house microelectronics facility is addressed. Industrial health standards, facility emission control requirements, operation and safety checklists, and the disposal of epitaxial vent gas are considered.

  13. Improved safety of biologic therapy for rheumatoid arthritis over the 8-year period since implementation in Japan: long-term results from a multicenter observational cohort study.

    PubMed

    Kojima, Toshihisa; Takahashi, Nobunori; Funahashi, Koji; Asai, Shuji; Terabe, Kenya; Kaneko, Atsushi; Hirano, Yuji; Hayashi, Masatoshi; Miyake, Hiroyuki; Oguchi, Takeshi; Takagi, Hideki; Kanayama, Yasuhide; Yabe, Yuichiro; Watanabe, Tsuyoshi; Fujibayashi, Takayoshi; Shioura, Tomone; Ito, Takayasu; Yoshioka, Yutaka; Ishikawa, Hisato; Asai, Nobuyuki; Takemoto, Toki; Kojima, Masayo; Ishiguro, Naoki

    2016-04-01

    This study aimed to compare the long-term safety of biologics by initiation year of treatment in patients with rheumatoid arthritis (RA) in Japan. RA patients who started their first biologics including infliximab, etanercept, adalimumab, and tocilizumab between 2003 and 2008 were identified in the Tsurumai Biologics Communication Registry (TBCR), multicenter observational cohort, and followed for 2 years or until discontinuation of the drugs. We identified baseline predictors for adverse events (AEs) resulting in discontinuation of the first TNFI using Cox proportional hazards regression analysis. A total of 874 cases (1,340 person-years) were observed. During the observation period, 96 AEs (4.7 events/100 person-years) occurred. From 2003 to 2008, there were significant changes in disease duration, Steinbrocker stage, and disease activity in those aged ≤64 years with no increase of incidence of AEs, whereas those aged >64 years had no significant changes in these variables. In the later initiation year of treatment with biologics, the fewer AEs were observed (log-rank, p = 0.017, 2008 vs. 2003-2005). Multivariate analysis showed that the initiation year significantly impacted the incidence of AEs 6 months into the observation period [initiation at 2008 (vs. 2003-2005): OR: 0.30, 95 % CI: (0.14-0.68)] after adjusting for variables at baseline. The decrease of AEs in the later initiation year was evident in those aged >64 years. The safety of biologic therapy improved over the course of the 8 years from its implementation in Japan. PMID:26846135

  14. Seismic Safety Study

    SciTech Connect

    Tokarz, F J; Coats, D W

    2006-05-16

    During the past three decades, the Laboratory has been proactive in providing a seismically safe working environment for its employees and the general public. Completed seismic upgrades during this period have exceeded $30M with over 24 buildings structurally upgraded. Nevertheless, seismic questions still frequently arise regarding the safety of existing buildings. To address these issues, a comprehensive study was undertaken to develop an improved understanding of the seismic integrity of the Laboratory's entire building inventory at the Livermore Main Site and Site 300. The completed study of February 2005 extended the results from the 1998 seismic safety study per Presidential Executive Order 12941, which required each federal agency to develop an inventory of its buildings and to estimate the cost of mitigating unacceptable seismic risks. Degenkolb Engineers, who performed the first study, was recontracted to perform structural evaluations, rank order the buildings based on their level of seismic deficiencies, and to develop conceptual rehabilitation schemes for the most seriously deficient buildings. Their evaluation is based on screening procedures and guidelines as established by the Interagency Committee on Seismic Safety in Construction (ICSSC). Currently, there is an inventory of 635 buildings in the Laboratory's Facility Information Management System's (FIMS's) database, out of which 58 buildings were identified by Degenkolb Engineers that require seismic rehabilitation. The remaining 577 buildings were judged to be adequate from a seismic safety viewpoint. The basis for these evaluations followed the seismic safety performance objectives of DOE standard (DOE STD 1020) Performance Category 1 (PC1). The 58 buildings were ranked according to three risk-based priority classifications (A, B, and C) as shown in Figure 1-1 (all 58 buildings have structural deficiencies). Table 1-1 provides a brief description of their expected performance and damage state

  15. Safety and Health Hazard Observations in Hmong Farming Operations

    PubMed Central

    Neitzel, R. L.; Krenz, J.; de Castro, A. B.

    2014-01-01

    Agricultural workers have a high risk of occupational injuries, illnesses, and fatalities. However, there are very few standardized tools available to assess safety and health in agricultural operations. Additionally, there are a number of groups of agricultural workers, including Hmong refugees and immigrants, for which virtually no information on safety and health conditions is available. This study developed an observation-based methodology for systematically evaluating occupational health and safety hazards in agriculture, and pilot-tested this on several small-scale Hmong farming operations. Each observation assessed of range of safety and health hazards (e.g., musculoskeletal hazards, dust and pollen, noise, and mechanical hazards), as well as on factors such as type of work area, presence of personal protective equipment, and weather conditions. Thirty-six observations were collected on nine farms. The most common hazards observed were bending at the back and lifting <50 pounds. Use of sharp tools without adequate guarding mechanisms, awkward postures, repetitive hand motions, and lifting >50 pounds were also common. The farming activities observed involved almost no power equipment, and no pesticide or chemical handling was observed. The use of personal protective equipment was uncommon. The results of this assessment agreed well with a parallel study of perceived safety and health hazards among Hmong agricultural workers. This study suggests that small-scale Hmong farming operations involve a variety of hazards, and that occupational health interventions may be warranted in this community. The study also demonstrates the utility of standardized assessment tools and mixed-method approaches to hazard evaluation. PMID:24911689

  16. Safety and health hazard observations in Hmong farming operations.

    PubMed

    Neitzel, R L; Krenz, J; de Castro, A B

    2014-01-01

    Agricultural workers have a high risk of occupational injuries, illnesses, and fatalities. However, there are very few standardized tools available to assess safety and health in agricultural operations. Additionally, there are a number of groups of agricultural workers, including Hmong refugees and immigrants, for which virtually no information on safety and health conditions is available. This study developed an observation-based methodology for systematically evaluating occupational health and safety hazards in agriculture, and pilot-tested this on several small-scale Hmong farming operations. Each observation assessed of range of safety and health hazards (e.g., musculoskeletal hazards, dust and pollen, noise, and mechanical hazards), as well as on factors such as type of work area, presence of personal protective equipment, and weather conditions. Thirty-six observations were collected on nine farms. The most common hazards observed were bending at the back and lifting <50 pounds. Use of sharp tools without adequate guarding mechanisms, awkward postures, repetitive hand motions, and lifting >50 pounds were also common. The farming activities observed involved almost no power equipment, and no pesticide or chemical handling was observed. The use of personal protective equipment was uncommon. The results of this assessment agreed well with a parallel study of perceived safety and health hazards among Hmong agricultural workers. This study suggests that small-scale Hmong farming operations involve a variety of hazards, and that occupational health interventions may be warranted in this community. The study also demonstrates the utility of standardized assessment tools and mixed-method approaches to hazard evaluation. PMID:24911689

  17. Effectiveness and safety of fixed dose combination of acarbose/metformin in Indian Type 2 diabetes patients: Results from observational GLOBE Study

    PubMed Central

    Saboo, Banshi; Reddy, Gundam Chandrasekhara; Juneja, Subhashchander; Kedia, Ashok Kumar; Manjrekar, Pravin; Rathod, Rahul

    2015-01-01

    Primary objective - evaluate effectiveness and safety of acarbose/metformin fixed dose FDC on glycemic control in Indian T2DM patients in real life clinical setting. Secondary objective - evaluate safety and satisfaction of treatment. Materials and Methods: Open-label, prospective, multicentre, single-arm, non-interventional study. Patients included were aged ≥18 years with T2DM on Acarbose (25/50 mg) and Metformin (500 mg) FDC. Glycemic parameters were recorded during observation. Results: Total 9364 patients were enrolled in the study (mean age, 50.7 years and 60.1% were male). Mean (SD) FBG and PPG was significantly reduced by 42.4 (32.6) mg/dl (P < 0.0001) and 80.2 (49.7) mg/dl (P < 0.0001) respectively at the end of observation. Mean (SD) HbA1c reduced by -1.0% (0.8) to 7.3% (0.7) at the last follow-up visit (P <0.0001). Majority of patients (97.5%) and physicians (98.42%) were satisfied with acarbose/metformin FDC treatment. Also, significant reduction in body weight by -1.7 (2.2) kg was observed (P < 0.0001). Patients with known T2DM and newly diagnosed showed a similar glycemic control (P < 0.0001). Drug-related adverse events were reported by only 1.4% patients mostly gastrointestinal. Conclusions: Acarbose/metformin FDC was efficacious, safe well accepted in routine clinical practice. It was well-tolerated without significant risk of hypoglycemia and can be used in early T2DM management PMID:25593840

  18. School Safety Study: Phase I.

    ERIC Educational Resources Information Center

    Arora, Alka

    This report summarizes findings from a study concerned with Arizona school safety. The survey component highlights safety-related policy information across 300 schools; the interview component highlights school-safety perceptions of 64 staff across 16 schools. Various policies and programs that respond to internal and external threats to school…

  19. The safety and efficacy of EGF-based cream for the prevention of radiotherapy-induced skin injury: results from a multicenter observational study

    PubMed Central

    Kang, Hyun-Cheol; Ahn, Seung-Do; Choi, Doo-Ho; Kang, Min Kyu; Chung, Woong-Ki

    2014-01-01

    Purpose This study was designed to evaluate the efficacy and safety of topically applied recombinant human epidermal growth factor (rhEGF) for the prevention of radiation-induced dermatitis in cancer patients. Materials and Methods From December 2010 to April 2012, a total of 1,172 cancer patients who received radiotherapy (RT) of more than 50 Gy were prospectively enrolled and treated with EGF-based cream. An acute skin reaction classified according to the Radiation Therapy Oncology Group 6-point rating scale was the primary end point and we also assessed the occurrence of edema, dry skin, or pruritus. Results The percentage of radiation dermatitis with maximum grade 0 and grade 1 was 19% and 58% at the time of 50 Gy, and it became 29% and 47% after completion of planned RT. This increment was observed only in breast cancer patients (from 18%/62% to 32%/49%). Adverse events related to the EGF-based cream developed in 49 patients (4%) with mild erythema the most common. Skin toxicity grade >2 was observed in 5% of the patients. Edema, dry skin, and pruritus grade ≥3 developed in 9%, 9%, and 1% of the patients, respectively. Conclusion Prophylactic use of an EGF-based cream is effective in preventing radiation dermatitis with tolerable toxicity. Further studies comparing EGF cream with other topical agents may be necessary. PMID:25324987

  20. Experience of safety monitoring in the context of a prospective observational study of artemether-lumefantrine in rural Tanzania: lessons learned for pharmacovigilance reporting

    PubMed Central

    2010-01-01

    Objectives To identify and implement strategies that help meet safety monitoring requirements in the context of an observational study for artemether-lumefantrine (AL) administered as first-line treatment for uncomplicated malaria in rural Tanzania. Methods Pharmacovigilance procedures were developed through collaboration between the investigating bodies, the relevant regulatory authority and the manufacturer of AL. Training and refresher sessions on the pharmacovigilance system were provided for healthcare workers from local health facilities and field recorders of the Ifakara Health Demographic Surveillance System (IHDSS). Three distinct channels for identification of adverse events (AEs) and serious adverse events (SAEs) were identified and implemented. Passive reporting took place through IHDSS and health care facilities, starting in October 2007. The third channel was through solicited reporting that was included in the context of a survey on AL as part of the ALIVE (Artemether-Lumefantrine In Vulnerable patients: Exploring health impact) study (conducted only in March-April 2008). Results Training was provided for 40 healthcare providers (with refresher training 18 months later) and for six field recorders. During the period 1st September 2007 to 31st March 2010, 67 AEs were reported including 52 under AL, five under sulphadoxine-pyrimethamine, one under metakelfin, two after antibiotics; the remaining seven were due to anti-pyretic or anti-parasite medications. Twenty patients experienced SAEs; in 16 cases, a relation to AL was suspected. Six of the 20 cases were reported within 24 hours of occurrence. Discussion Safety monitoring and reporting is possible even in settings with weak health infrastructure. Reporting can be enhanced by regular and appropriate training of healthcare providers. SMS text alerts provide a practical solution to communication challenges. Conclusion Experience gained in this setting could help to improve spontaneous reporting of AEs

  1. Nuclear explosive safety study process

    SciTech Connect

    1997-01-01

    Nuclear explosives by their design and intended use require collocation of high explosives and fissile material. The design agencies are responsible for designing safety into the nuclear explosive and processes involving the nuclear explosive. The methodology for ensuring safety consists of independent review processes that include the national laboratories, Operations Offices, Headquarters, and responsible Area Offices and operating contractors with expertise in nuclear explosive safety. A NES Study is an evaluation of the adequacy of positive measures to minimize the possibility of an inadvertent or deliberate unauthorized nuclear detonation, high explosive detonation or deflagration, fire, or fissile material dispersal from the pit. The Nuclear Explosive Safety Study Group (NESSG) evaluates nuclear explosive operations against the Nuclear Explosive Safety Standards specified in DOE O 452.2 using systematic evaluation techniques. These Safety Standards must be satisfied for nuclear explosive operations.

  2. The Safety and Acceptance of the PrePex Device for Non-Surgical Adult Male Circumcision in Rakai, Uganda. A Non-Randomized Observational Study

    PubMed Central

    Kigozi, Godfrey; Musoke, Richard; Watya, Stephen; Kighoma, Nehemia; Nkale, James; Nakafeero, Mary; Namuguzi, Dan; Serwada, David; Nalugoda, Fred; Sewankambo, Nelson; Wawer, Maria Joan; Gray, Ronald Henry

    2014-01-01

    Objectives To assess the safety and acceptance of the PrePex device for medical male circumcision (MMC) in rural Uganda. Methods In an observational study, HIV-uninfected, uncircumcised men aged 18 and older who requested elective MMC were informed about the PrePex and dorsal slit methods and offered a free choice of their preferred procedure. 100 men received PrePex to assess preliminary safety (aim 1). An additional 329 men, 250 chose PrePex and 79 chose Dorsal slit, were enrolled following approval by the Safety Monitoring Committee (aim 2). Men were followed up at 7 days to assess adverse events (AEs) and to remove the PrePex device. Wound healing was assessed at 4 weeks, with subsequent weekly follow up until completed healing. Results The PrePex device was contraindicated in 5.7% of men due to a tight prepuce or phimosis/adhesions. Among 429 enrolled men 350 (82.0%) got the PrePex device and 79 (18.0%) the dorsal slit procedure. 250 of 329 men (76.0%) who were invited to choose between the 2 procedures chose Prepex. There were 9 AEs (2.6%) with the PrePex, of which 5 (1.4%) were severe complications, 4 due to patient self-removal of the device leading to edema and urinary obstruction requiring emergency surgical circumcision, and one due to wound dehiscence following device removal. 71.8% of men reported an unpleasant odor prior to PrePex removal. Cumulative rates of completed wound healing with the PrePex were 56.7% at week 4, 84.8% week 5, 97.6% week 6 and 98.6% week 7, compared to 98.7% at week 4 with dorsal slit (p<0.0001). Conclusion The PrePex device was well accepted, but healing was slower than with dorsal slit surgery. Severe complications, primarily following PrePex self-removal, required rapid access to emergency surgical facilities. The need to return for removal and delayed healing may increase Program cost and client burden. PMID:25144194

  3. Effects and safety profile of betahistine in patients in the Russian contingent of OSVaLD, an open-label observational study in vestibular vertigo

    PubMed Central

    Morozova, Svetlana Vyacheslavovna; Alekseeva, Natalia Stepanovna; Lilenko, Sergey Vasilyevich; Matsnev, Eduard Ivanovich; Melnikov, Oleg Anatol’evich

    2015-01-01

    Background We report here data from the >200 patients recruited in Russia to take part in OSVaLD, a 12-week, open-label, post-marketing surveillance study of the response to betahistine 48 mg/day in vertigo of peripheral vestibular origin carried out in a total of 13 countries. Methods The primary efficacy endpoint was change in the Dizziness Handicap Inventory (DHI; 100-point scale). Changes in Hospital Anxiety and Depression Scale (HADS) and Medical Outcomes Study Short-Form 36, version 2 (SF-36v2®) scores were a priori secondary Outcomes. Results Total DHI score improved by 43 points during betahistine treatment. This aggregate improvement was equally distributed across the three domains of the DHI (physical, emotional, and functional; P<0.0001 for main and subscore changes from baseline). Statistically significant improvements versus baseline were also observed in mean HADS scores for anxiety and depression (both P<0.0001), and in the Physical Component Summary and Mental Component Summary scores of the SF-36v2 (both P<0.0001 versus baseline). Only one suspected adverse drug reaction was recorded in the Russian safety population (n=204), indicating that betahistine was well tolerated in those patients. Conclusion Betahistine 48 mg/day was associated with clear improvements in well-configured and widely validated measures of health-related quality of life and an encouraging tolerability profile in patients in Russia who took part in OSVaLD. PMID:25653552

  4. Long-term food consumption and body weight changes in neotame safety studies are consistent with the allometric relationship observed for other sweeteners and during dietary restrictions.

    PubMed

    Flamm, W Gary; Blackburn, George L; Comer, C Phil; Mayhew, Dale A; Stargel, W Wayne

    2003-10-01

    In long-term safety studies with neotame, a new high-intensity sweetener 7000-13,000 times sweeter than sucrose, the percent changes (%Delta) in body weight gain (BWG) in Sprague-Dawley rats were several-fold greater than the %Delta in overall food consumption (FC). This study investigates the question of whether the changes in BWG were adverse or secondary to small, long-term decrements in FC. The hypothesis tested in Sprague-Dawley rats was that the relationship between long-term %Delta in FC and %Delta in BWG is linear and in a ratio of 1:1. The %Delta in FC were compared to %Delta in BWG after 52 weeks on study in one saccharin (825 rats), two sucralose (480 rats), two neotame (630 rats), and five dietary restriction (>1000 rats) studies. Non-transformed plotting of data points demonstrated an absence of linearity between %Delta in FC and %Delta in BWG; however, log-log evaluation demonstrated a robust (R2=0.97) linear relationship between %Delta in FC and %Delta in BWG. This relationship followed the well-known allometric equation, y=bxa where x is %DeltaFC, y is %DeltaBWG, b is %DeltaBWG when DeltaFC=1, and a is the log-log slope. Thus, in Sprague-Dawley rats at week 52, the long-term relationship between %Delta in FC and %Delta in BWG was determined to be: %DeltaBWG=3.45(%DeltaFC0.74) for males and %DeltaBWG=5.28(%DeltaFC0.68) for females. Sexes were statistically different but study types, i.e., the high-intensity sweeteners saccharin and sucralose versus dietary restriction, were not. The %Delta in BWG are allometrically consistent with the observed %Delta in FC for these high-intensity sweeteners, including neotame. BW parameters are not appropriate endpoints for setting no-observed-effect levels (NOELs) when materials with intense taste are admixed into food. An approach using objective criteria is proposed to delineate BW changes due to toxicity from those secondary to reduced FC. PMID:14550756

  5. Evaluation of effectiveness and safety of amlodipine/valsartan/hydrochlorothiazide single-pill combination therapy in hypertensive patients: an observational study

    PubMed Central

    Hagendorff, Andreas; Kurz, Ira; Müller, Alfons; Klebs, Sven

    2014-01-01

    Objective This study evaluated the effectiveness and safety of amlodipine/valsartan/hydrochlorothiazide (A + V + H) single-pill combination therapy in the treatment of hypertensive patients in daily practice. Design and methods This prospective, open-label, observational study, enroled adults for whom their physician considered treatment with the single pill combination as indicated. The observational period per patient was ∼3 months. Results were evaluated using basic descriptive statistical methods. Main outcome Data of 7132 patients were analyzed. At baseline, the mean blood pressure (BP) was 158.8 ± 17.7 mmHg (systolic, sBP) and 91.5 ± 10.7 mmHg (diastolic, dBP). The most common cardiovascular risk factors were positive family history, dyslipidemia, and diabetes mellitus. The most commonly used daily doses of A + V + H at study end were 5/160/12.5 mg (30.5%) or 10/160/12.5 mg (33.1%). At the last visit mean BP was 135.0 ± 11.8 mmHg (sBP) and 80.2 ± 7.3 mmHg (dBP). The mean BP reduction at last visit compared with baseline was −23.7 ± 17.5 mmHg (sBP) and −11.3 ± 10.6 mmHg (dBP); 43.5% of the patients reached normalization (BP <140/90 mmHg for non-diabetics or <130/80 mmHg for diabetics) and 71.3% reached therapeutic response (sBP <140 or ≥20 mmHg decrease vs baseline and dBP <90 or ≥10 mmHg decrease vs baseline in non-diabetic patients and sBP <130 mmHg or ≥20 mmHg decrease vs baseline and dBP <80 mmHg or ≥10 mmHg decrease vs baseline in patients with diabetes). Adverse events (AEs) were recorded in 2.3% of the patients, the most frequent being peripheral edema (0.6%) and dizziness (0.2%). Conclusions In daily practice, A + V + H single-pill treatment effectively lowered the average BP in patients with essential hypertension and was well tolerated.

  6. Efficacy and safety during formulation switch of a pasteurized VWF/FVIII concentrate: results from an Italian prospective observational study in patients with von Willebrand disease.

    PubMed

    Castaman, G; Coppola, A; Zanon, E; Boeri, E; Musso, M; Siragusa, S; Federici, A B; Mancuso, G; Barillari, G; Biasoli, C; Feola, G; Franchini, M; Moratelli, S; Gamba, G; Schinco, P; Valdrè, L; Dragani, A; Mazzucconi, G; Tagliaferri, A; Morfini, M

    2013-01-01

    Von Willebrand disease (VWD) is an inherited bleeding disorder caused by the quantitative or qualitative deficiency of von Willebrand factor (VWF). Replacement therapy with plasma-derived VWF/factor VIII (FVIII) concentrates is required in patients unresponsive to desmopressin. To assess the efficacy, safety and ease of use of a new, volume-reduced (VR) formulation of VWF/FVIII concentrate Haemate(®) P in patients requiring treatment for bleeding or prophylaxis for recurrent bleeding or for invasive procedures. Pharmacoeconomic variables were also recorded. Data were analysed using descriptive statistics. This was a multicentre, prospective, observational study. Consecutively enrolled patients received Haemate(®) P VR according to their needs, and were followed for 24 months. Of the 121 patients enrolled, 25.6% had type 3 VWD and more than 40% had severe disease. All patients were followed for 2 years, for a total of 521 visits. On-demand treatment was given to 61.9% of patients, secondary long-term prophylaxis to 25.6% and prophylaxis for surgery, dental or invasive procedures to 45.5%. The response to treatment was rated as good to excellent in >93-99% of interventions. The new formulation was well tolerated by all patients with no report of drug-related adverse events. The switch to volume-reduced Haemate(®) P was easy to perform and infusion duration was decreased twofold compared with the previous formulation. Volume-reduced Haemate(®) P was at least as effective and well-tolerated as the previous formulation. PMID:22957493

  7. Distracted Biking: An Observational Study.

    PubMed

    Wolfe, Elizabeth Suzanne; Arabian, Sandra Strack; Breeze, Janis L; Salzler, Matthew J

    2016-01-01

    Commuting via bicycle is a very popular mode of transportation in the Northeastern United States. Boston, MA, has seen a rapid increase in bicycle ridership over the past decade, which has raised concerns and awareness about bicycle safety. An emerging topic in this field is distracted bicycle riding. This study was conducted to provide descriptive data on the prevalence and type of distracted bicycling in Boston at different times of day. This was a cross-sectional study in which observers tallied bicyclists at 4 high traffic intersections in Boston during various peak commuting hours for 2 types of distractions: auditory (earbuds/phones in or on ears), and visual/tactile (electronic device or other object in hand). Nineteen hundred seventy-four bicyclists were observed and 615 (31.2%), 95% CI [29, 33%], were distracted. Of those observed, auditory distractions were the most common (N = 349; 17.7%), 95% CI [16, 19], p = .0003, followed by visual/tactile distractions (N = 266; 13.5%), 95% CI [12, 15]. The highest proportion (40.7%), 95% CI [35, 46], of distracted bicyclists was observed during the midday commute (between 13:30 and 15:00). Distracted bicycling is a prevalent safety concern in the city of Boston, as almost a third of all bicyclists exhibited distracted behavior. Education and public awareness campaigns should be designed to decrease distracted bicycling behaviors and promote bicycle safety in Boston. An awareness of the prevalence of distracted biking can be utilized to promote bicycle safety campaigns dedicated to decreasing distracted bicycling and to provide a baseline against which improvements can be measured. PMID:26953533

  8. Safety and effectiveness of daily teriparatide in a prospective observational study in patients with osteoporosis at high risk of fracture in Japan: final report.

    PubMed

    Nishikawa, Atsushi; Ishida, Takehiro; Taketsuna, Masanori; Yoshiki, Fumito; Enomoto, Hiroyuki

    2016-01-01

    This postmarketing surveillance study assessed the safety and effectiveness of teriparatide in patients with osteoporosis at high risk of fracture in Japan. The patients received teriparatide 20 μg daily by subcutaneous injection, for a maximum of 24 months. Safety and effectiveness analyses were based on data from 1,847 patients who were predominantly female (92.6%) with a mean age of 75.4 years. A total of 157 adverse drug reactions (ADRs) were reported in 140 (7.58%) patients; the most common ADRs were hyperuricemia, nausea, and dizziness. Only six (0.32%) patients reported serious ADRs, the most common being nausea (two patients; 0.1%). Persistence with teriparatide treatment was 60.8% and 39.1% at 18 and 24 months, respectively. There were significant increases in biomarkers for bone formation (procollagen type I N-terminal propeptide and bone-specific alkaline phosphatase) and bone resorption (collagen type I cross-linked C telopeptide and tartrate-resistant acid phosphatase 5b) throughout the study. These were accompanied by significant increases in bone mineral density and low incidences of new vertebral and nonvertebral fractures. Patient-reported measurements for health-related quality of life revealed significant improvements from baseline in back pain and overall health-related quality of life (Short Form-8™ health survey). The results of this 24-month postmarketing surveillance study imply that teriparatide has a favorable safety profile and is effective in the treatment of patients with osteoporosis at high risk of fracture in Japan. Teriparatide may also be a useful treatment for osteoporosis in other societies with aging populations. PMID:27462147

  9. Safety and effectiveness of daily teriparatide in a prospective observational study in patients with osteoporosis at high risk of fracture in Japan: final report

    PubMed Central

    Nishikawa, Atsushi; Ishida, Takehiro; Taketsuna, Masanori; Yoshiki, Fumito; Enomoto, Hiroyuki

    2016-01-01

    This postmarketing surveillance study assessed the safety and effectiveness of teriparatide in patients with osteoporosis at high risk of fracture in Japan. The patients received teriparatide 20 μg daily by subcutaneous injection, for a maximum of 24 months. Safety and effectiveness analyses were based on data from 1,847 patients who were predominantly female (92.6%) with a mean age of 75.4 years. A total of 157 adverse drug reactions (ADRs) were reported in 140 (7.58%) patients; the most common ADRs were hyperuricemia, nausea, and dizziness. Only six (0.32%) patients reported serious ADRs, the most common being nausea (two patients; 0.1%). Persistence with teriparatide treatment was 60.8% and 39.1% at 18 and 24 months, respectively. There were significant increases in biomarkers for bone formation (procollagen type I N-terminal propeptide and bone-specific alkaline phosphatase) and bone resorption (collagen type I cross-linked C telopeptide and tartrate-resistant acid phosphatase 5b) throughout the study. These were accompanied by significant increases in bone mineral density and low incidences of new vertebral and nonvertebral fractures. Patient-reported measurements for health-related quality of life revealed significant improvements from baseline in back pain and overall health-related quality of life (Short Form-8™ health survey). The results of this 24-month postmarketing surveillance study imply that teriparatide has a favorable safety profile and is effective in the treatment of patients with osteoporosis at high risk of fracture in Japan. Teriparatide may also be a useful treatment for osteoporosis in other societies with aging populations. PMID:27462147

  10. An Observational, Multicenter, Cohort Study Evaluating the Antiviral Efficacy and Safety in Korean Patients With Chronic Hepatitis B Receiving Pegylated Interferon-alpha 2a (Pegasys): TRACES Study.

    PubMed

    Chon, Young Eun; Kim, Dong Joon; Kim, Sang Gyune; Kim, In Hee; Bae, Si Hyun; Hwang, Seong Gyu; Heo, Jeong; Jang, Jeong Won; Lee, Byung Seok; Kim, Hyung Joon; Jun, Dae Won; Kim, Kang Mo; Chung, Woo Jin; Choi, Moon Seok; Jang, Jae Young; Yim, Hyung Joon; Tak, Won Young; Yoon, Ki Tae; Park, Jun Yong; Han, Kwang-Hyub; Suk, Ki Tae; Lee, Hyun Woong; Jang, Byoung Kuk; Ahn, Sang Hoon

    2016-04-01

    Currently, limited data are available regarding the efficacy and safety of pegylated interferon alpha-2a (PEG-IFN α-2a) in Korean patients with chronic hepatitis B (CHB), in whom hepatitis B virus (HBV) genotype C is the most common type.We collected data from 439 patients (HBeAg positive, n = 349; HBeAg negative, n = 90) with CHB who were treated with PEG-IFN α-2a as a first-line therapy from 18 institutions. Treatment responses at the end of treatment (ET) and at 6 months posttreatment (PT6) were compared between the patients who were treated for 24 weeks versus 48 weeks, and adverse events (AEs) were evaluated.In HBeAg-positive patients, those who received PEG-IFN α-2a for 48 weeks showed significantly higher HBV DNA suppression (HBV DNA < 2000 IU/mL) than those who were treated for 24 weeks (48 weeks vs 24 weeks; at ET, 44.4% vs 36.7%, P = 0.035; at PT6, 35.9% vs 13.3%, P = 0.035). The HBeAg seroconversion rate at ET was 18.1% in 48-week treatment group, which is significantly higher than the 2.2% (P < 0.001) that was seen in 24-week treatment group. This finding also continued at PT6 (29.0% vs 10.0%, P < 0.001). Following 48 weeks of treatment in HBeAg-negative patients, HBV DNA suppression at ET was higher than in HBeAg-positive patients (87.8% vs 44.4%). AEs were typical of those associated with PEG-IFN α-2a.In naïve Korean HBeAg-positive CHB patients treated with PEG-IFN α-2a, higher rates of HBV DNA suppression and HBeAg seroconversion were achieved in the 48-week treatment group than in the 24-week treatment group without additional risk of AEs. PMID:27057828

  11. Safety and feasibility of the RhinoChill immediate transnasal evaporative cooling device during out-of-hospital cardiopulmonary resuscitation: A single-center, observational study.

    PubMed

    Grave, Marie-Sophie; Sterz, Fritz; Nürnberger, Alexander; Fykatas, Stergios; Gatterbauer, Mathias; Stättermayer, Albert Friedrich; Zajicek, Andreas; Malzer, Reinhard; Sebald, Dieter; van Tulder, Raphael

    2016-08-01

    We investigated feasibility and safety of the RhinoChill (RC) transnasal cooling system initiated before achieving a protected airway during cardiopulmonary resuscitation (CPR) in a prehospital setting.In out-of-hospital cardiac arrest (OHCA), transnasal evaporative cooling was initiated during CPR, before a protected airway was established and continued until either the patient was declared dead, standard institutional systemic cooling methods were implemented or cooling supply was empty. Patients were monitored throughout the hypothermia period until either death or hospital discharge. Clinical assessments and relevant adverse events (AEs) were documented over this period of time.In total 21 patients were included. Four were excluded due to user errors or meeting exclusion criteria. Finally, 17 patients (f = 6; mean age 65.5 years, CI95%: 57.7-73.4) were analyzed. Device-related AEs, like epistaxis or nose whitening, occurred in 2 patients. They were mild and had no consequence on the patient's outcome. According to the field reports of the emergency medical services (EMS) personnel, no severe technical problems occurred by using the RC device that led to a delay or the impairment of quality of the CPR.Early application of the RC device, during OHCA is feasible, safe, easy to handle, and does not delay or hinder CPR, or establishment of a secure intubation. For efficacy and further safety data additional studies will be needed. PMID:27559978

  12. Safety study application guide. Safety Analysis Report Update Program

    SciTech Connect

    Not Available

    1993-07-01

    Martin Marietta Energy Systems, Inc., (Energy Systems) is committed to performing and documenting safety analyses for facilities it manages for the Department of Energy (DOE). Included are analyses of existing facilities done under the aegis of the Safety Analysis Report Upgrade Program, and analyses of new and modified facilities. A graded approach is used wherein the level of analysis and documentation for each facility is commensurate with the magnitude of the hazard(s), the complexity of the facility and the stage of the facility life cycle. Safety analysis reports (SARs) for hazard Category 1 and 2 facilities are usually detailed and extensive because these categories are associated with public health and safety risk. SARs for Category 3 are normally much less extensive because the risk to public health and safety is slight. At Energy Systems, safety studies are the name given to SARs for Category 3 (formerly {open_quotes}low{close_quotes}) facilities. Safety studies are the appropriate instrument when on-site risks are limited to irreversible consequences to a few people, and off-site consequences are limited to reversible consequences to a few people. This application guide provides detailed instructions for performing safety studies that meet the requirements of DOE Orders 5480.22, {open_quotes}Technical Safety Requirements,{close_quotes} and 5480.23, {open_quotes}Nuclear Safety Analysis Reports.{close_quotes} A seven-chapter format has been adopted for safety studies. This format allows for discussion of all the items required by DOE Order 5480.23 and for the discussions to be readily traceable to the listing in the order. The chapter titles are: (1) Introduction and Summary, (2) Site, (3) Facility Description, (4) Safety Basis, (5) Hazardous Material Management, (6) Management, Organization, and Institutional Safety Provisions, and (7) Accident Analysis.

  13. MAXimising Involvement in MUltiMorbidity (MAXIMUM) in primary care: protocol for an observation and interview study of patients, GPs and other care providers to identify ways of reducing patient safety failures

    PubMed Central

    Daker-White, Gavin; Hays, Rebecca; Esmail, Aneez; Minor, Brian; Barlow, Wendy; Brown, Benjamin; Blakeman, Thomas; Bower, Peter

    2014-01-01

    Introduction Increasing numbers of older people are living with multiple long-term health conditions but global healthcare systems and clinical guidelines have traditionally focused on the management of single conditions. Having two or more long-term conditions, or ‘multimorbidity’, is associated with a range of adverse consequences and poor outcomes and could put patients at increased risk of safety failures. Traditionally, most research into patient safety failures has explored hospital or inpatient settings. Much less is known about patient safety failures in primary care. Our core aims are to understand the mechanisms by which multimorbidity leads to safety failures, to explore the different ways in which patients and services respond (or fail to respond), and to identify opportunities for intervention. Methods and analysis We plan to undertake an applied ethnographic study of patients with multimorbidity. Patients’ interactions and environments, relevant to their healthcare, will be studied through observations, diary methods and semistructured interviews. A framework, based on previous studies, will be used to organise the collection and analysis of field notes, observations and other qualitative data. This framework includes the domains: access breakdowns, communication breakdowns, continuity of care errors, relationship breakdowns and technical errors. Ethics and dissemination Ethical approval was received from the National Health Service Research Ethics Committee for Wales. An individual case study approach is likely to be most fruitful for exploring the mechanisms by which multimorbidity leads to safety failures. A longitudinal and multiperspective approach will allow for the constant comparison of patient, carer and healthcare worker expectations and experiences related to the provision, integration and management of complex care. This data will be used to explore ways of engaging patients and carers more in their own care using shared decision

  14. An Open Multicenter Study of Clinical Efficacy and Safety of Urolastic, an Injectable Implant for the Treatment of Stress Urinary Incontinence: One-Year Observation

    PubMed Central

    Miotła, Paweł; Gałczyński, Krzysztof; Baranowski, Włodzimierz; Doniec, Jacek; Jóźwik, Maciej; Oniszczuk, Małgorzata; Rechberger, Tomasz

    2015-01-01

    The prevalence of stress urinary incontinence rises and affects up to 30% of women after 50 years of age. Midurethral slings are currently the mainstay of surgical anti-incontinence therapy. Some patients experience recurrent SUI (RSUI) which is defined as a failure of anti-incontinence surgery after a period of time or persistence of SUI after the procedure aimed at correcting it. The urethral bulking agent application decreases invasiveness of treatment and meets patients requirements. The objective of this study was to assess the safety and clinical efficacy of Urolastic injection. One hundred and five patients with SUI (including 91 patients with RSUI) were treated with Urolastic in three tertiary gynecological clinics. The efficacy of the procedure was assessed objectively at each follow-up visit by means of cough test and a standard 1-hour pad test. Objective success rate after 12 months after primary procedure in RSUI patients was found in 59.3% of patients. In 14 patients with primary SUI improvement after 1 year was found in 71.4% of patients. Although cure rates after MUS are up to 90% there is still place for less invasive treatment option like periurethral injection of bulking agents, especially in patients with previous SUI surgical management. PMID:26106616

  15. An Open Multicenter Study of Clinical Efficacy and Safety of Urolastic, an Injectable Implant for the Treatment of Stress Urinary Incontinence: One-Year Observation.

    PubMed

    Futyma, Konrad; Miotła, Paweł; Gałczyński, Krzysztof; Baranowski, Włodzimierz; Doniec, Jacek; Wodzisławska, Agnieszka; Jóźwik, Maciej; Oniszczuk, Małgorzata; Rechberger, Tomasz

    2015-01-01

    The prevalence of stress urinary incontinence rises and affects up to 30% of women after 50 years of age. Midurethral slings are currently the mainstay of surgical anti-incontinence therapy. Some patients experience recurrent SUI (RSUI) which is defined as a failure of anti-incontinence surgery after a period of time or persistence of SUI after the procedure aimed at correcting it. The urethral bulking agent application decreases invasiveness of treatment and meets patients requirements. The objective of this study was to assess the safety and clinical efficacy of Urolastic injection. One hundred and five patients with SUI (including 91 patients with RSUI) were treated with Urolastic in three tertiary gynecological clinics. The efficacy of the procedure was assessed objectively at each follow-up visit by means of cough test and a standard 1-hour pad test. Objective success rate after 12 months after primary procedure in RSUI patients was found in 59.3% of patients. In 14 patients with primary SUI improvement after 1 year was found in 71.4% of patients. Although cure rates after MUS are up to 90% there is still place for less invasive treatment option like periurethral injection of bulking agents, especially in patients with previous SUI surgical management. PMID:26106616

  16. Subsonic Aircraft Safety Icing Study

    NASA Technical Reports Server (NTRS)

    Jones, Sharon Monica; Reveley, Mary S.; Evans, Joni K.; Barrientos, Francesca A.

    2008-01-01

    NASA's Integrated Resilient Aircraft Control (IRAC) Project is one of four projects within the agency s Aviation Safety Program (AvSafe) in the Aeronautics Research Mission Directorate (ARMD). The IRAC Project, which was redesigned in the first half of 2007, conducts research to advance the state of the art in aircraft control design tools and techniques. A "Key Decision Point" was established for fiscal year 2007 with the following expected outcomes: document the most currently available statistical/prognostic data associated with icing for subsonic transport, summarize reports by subject matter experts in icing research on current knowledge of icing effects on control parameters and establish future requirements for icing research for subsonic transports including the appropriate alignment. This study contains: (1) statistical analyses of accident and incident data conducted by NASA researchers for this "Key Decision Point", (2) an examination of icing in other recent statistically based studies, (3) a summary of aviation safety priority lists that have been developed by various subject-matter experts, including the significance of aircraft icing research in these lists and (4) suggested future requirements for NASA icing research. The review of several studies by subject-matter experts was summarized into four high-priority icing research areas. Based on the Integrated Resilient Aircraft Control (IRAC) Project goals and objectives, the IRAC project was encouraged to conduct work in all of the high-priority icing research areas that were identified, with the exception of the developing of methods to sense and document actual icing conditions.

  17. Skylab Earth Observation Studies

    NASA Technical Reports Server (NTRS)

    1972-01-01

    This concept illustrates Skylab Earth observation studies, an Earth Resources Experiment Package (EREP). EREP was designed to explore the use of the widest possible portion of the electromagnetic spectrum for Earth resource investigations with sensors that recorded data in the visible, infrared, and microwave spectral regions. Resources subject to this study included a capability of mapping Earth resources and land uses, crop and forestry cover, health of vegetation, types of soil, water storage in snow pack, surface or near-surface mineral deposits, sea surface temperature, and the location of likely feeding areas for fish, etc. A significant feature of EREP was the ability of man to operate the sensors in a laboratory fashion.

  18. A retrospective observational study on the safety and efficacy of first-line treatment with bevacizumab combined with FOLFIRI in metastatic colorectal cancer

    PubMed Central

    López, R; Salgado, M; Reboredo, M; Grande, C; Méndez, J C; Jorge, M; Romero, C; Quintero, G; de la Cámara, J; Candamio, S

    2010-01-01

    Background: Combination of bevacizumab and FOLFIRI has currently become one of the standard therapeutic regimens. However, published information is still limited. The objective of the present retrospective observational study is to analyse the response and toxicity of first-line treatment with FOLFIRI+bevacizumab in patients with metastatic colorectal cancer (mCRC). Methods: Data were collected from patients from nine Spanish sites diagnosed with mCRC, ECOG⩽2, whose first treatment for advanced disease was at least three cycles of FOLFIRI+bevacizumab. Results: A total of 95 patients were enrolled into the study: 64.2% males, median age of 59 years (53.2–67.1 years), ECOG=0–1 in 96.9% of patients. The main site of primary tumour was the colon (69.7%), and most metastases occurred in the liver (71.6%). Clinical benefit was detected in 67.4% (57.0–76.6; 95% confidence interval (CI)), with 8.4% of CR and 42.1% of PR. Median TTP was 10.6 months (10.0–11.3; 95% CI), PFS was 10.6 months (9.8–11.3; 95% CI), and OS was 20.7 months (17.1–24.2; 95% CI). Main grade I–II toxicities included haematological toxicity (35.8%), diarrhea (27.3%), mucositis (25.3%), asthenia (19.0%), haemorrhages (11.6%), and emesis (10.6%). Toxicities reaching grades III–IV were haematological toxicity (9.5%), diarrhea (8.5%), mucositis (5.3%), hepatic toxicity (2.1%), asthenia (2.1%), proteinuria (1.1%), emesis (1.1%), pain (1.1%), and colics (1.1%). Conclusion: Results of this study support the beneficial effect of adding bevacizumab to FOLFIRI regimen in terms of efficacy and show a favourable tolerability profile. PMID:20940719

  19. Using Total Lightning Observations to Enhance Lightning Safety

    NASA Technical Reports Server (NTRS)

    Stano, Geoffrey T.

    2012-01-01

    Lightning is often the underrated threat faced by the public when it comes to dangerous weather phenomena. Typically, larger scale events such as floods, hurricanes, and tornadoes receive the vast majority of attention by both the general population and the media. This comes from the fact that these phenomena are large, longer lasting, can impact a large swath of society at one time, and are dangerous events. The threat of lightning is far more isolated on a case by case basis, although millions of cloud-to-ground lightning strikes hit this United States each year. While attention is given to larger meteorological events, lightning is the second leading cause of weather related deaths in the United States. This information raises the question of what steps can be taken to improve lightning safety. Already, the meteorological community s understanding of lightning has increased over the last 20 years. Lightning safety is now better addressed with the National Weather Service s access to the National Lightning Detection Network data and enhanced wording in their severe weather warnings. Also, local groups and organizations are working to improve public awareness of lightning safety with easy phrases to remember, such as "When Thunder Roars, Go Indoors." The impacts can be seen in the greater array of contingency plans, from airports to sports stadiums, addressing the threat of lightning. Improvements can still be made and newer technologies may offer new tools as we look towards the future. One of these tools is a network of sensors called a lightning mapping array (LMA). Several of these networks exist across the United States. NASA s Short-term Prediction Research and Transition Center (SPoRT), part of the Marshall Spaceflight Center, has access to three of these networks from Huntsville, Alabama, the Kennedy Space Center, and Washington D.C. The SPoRT program s mission is to help transition unique products and observations into the operational forecast environment

  20. Group theories: relevance to group safety studies.

    PubMed

    Benevento, A L

    1998-01-01

    Promoting safety in the workplace has been attempted in a variety of ways. Increasingly, industries are using groups such as safety teams and quality circles to promote worker safety. Group influences on individual behavior and attitudes have long been studied in the social psychology literature, but the theories have not been commonly found outside the psychology arena. This paper describes the group theories of group polarization, risky shift, social loafing, groupthink and team think and attempts to apply these theories to existing studies that examine work group influences on safety. Interesting parallels were found but only one study examined group influences as their primary focus of research. Since groups are increasingly used for safety promotion, future research on safety that studies group influences with respect to current group theories is recommended. PMID:24441299

  1. Reported Significant Observation (RSO) studies. Revision 1

    SciTech Connect

    Eicher, R.W.

    1992-12-01

    The Reported Significant Observation (RSO) study used in the field of safety is an information-gathering technique where employee-participants describe situations they have personally witnessed involving good and bad practices and safe and unsafe conditions. This information is useful in the risk assessment process because it focuses on hazards and thereby facilitates their elimination. However, RSO cannot be the only component in a risk assessment program. Used by the Air Force in their aviation psychology program and further developed by John C. Flanagan, RSO is more commonly known as the ``Critical Incident Technique.`` However, the words ``Critical`` and ``Incident`` had other connotations in nuclear safety, prompting early users within the Aerojet Nuclear Company to coin the more fitting title of ``Reported Significant Observations.`` The technique spread slowly in the safety field primarily because the majority of users were researchers interested in after-the-fact data, with application to everyday problems and behavioral factors. RSO was formally recognized as a significant hazard reduction tool during the development of the Management Oversight and Risk Tree (MORT) program for the US Atomic Energy Commission. The Department of Energy (DOE) has, in turn, adopted MORT for its system safety program, and this has resulted in RSO being a modern and viable technique for DOE contractor safety programs.

  2. Short Term Efficacy and Safety of Low Dose Tolvaptan in Patients with Acute Decompensated Heart Failure with Hyponatremia: A Prospective Observational Pilot Study from a Single Center in South India

    PubMed Central

    Patra, Soumya; Kumar, Basant; Harlalka, Kaushal K.; Jain, Apoorva; Bhanuprakash, H. M.; Sadananda, K. S.; Basappa, Harsha; Santhosh, K.; Rajith, K. S.; Bharathi, K. S.; Manjunath, C. N.

    2014-01-01

    Background: In acute decompensated heart failure (ADHF), diuretic use, the mainstay therapy for congestion, is associated with electrolyte abnormalities and worsening renal function. Vasopressin mediates fluid retention in heart failure. In contrast to diuretics, the vasopressin antagonist tolvaptan may increase net volume loss in heart failure without adversely affecting electrolytes and renal function. Hyponatremia (serum sodium concentration, <135 mEq/L) is a predictor of death among patients with heart failure. Objective: We prospectively observed the short term efficacy and safety of low dose (15 mg) tolvaptan in admitted patients with hyponatremia and ADHF in Indian population. Methodology: A total of 40 patients with ADHF along with hyponatremia (<125 mEq/L) on standard therapy were treated with 15 mg of tolvaptan at a single oral dose for 7 days. Results: Serum sodium concentrations increased significantly after treatment with tolvaptan from baseline (P < 0.02). There was a significant improvement in symptoms and New York Heart Association (NYHA) class after starting tolvaptan (P ≤ 0.05). Total diuretic dose and mean body weight was reduced non-significantly at 7th day from the baseline. Side-effects associated with tolvaptan included increased thirst, dry mouth and increased urination. Few patients had worsening renal function. However, several patients developed hypernatremia. Conclusion: In this small observational study, tolvaptan initiation in patients with ADHF with hyponatremia in addition to standard therapy may hold promise in improvement in NYHA class and serum sodium. At the same time, we observed that serious adverse events such as renal function deterioration and hypernatremia developed after tolvaptan treatment, which needs to be addressed in future by randomized study with larger sample size. PMID:24949180

  3. Criticality safety basics, a study guide

    SciTech Connect

    V. L. Putman

    1999-09-01

    This document is a self-study and classroom guide, for criticality safety of activities with fissile materials outside nuclear reactors. This guide provides a basic overview of criticality safety and criticality accident prevention methods divided into three parts: theory, application, and history. Except for topic emphasis, theory and history information is general, while application information is specific to the Idaho National Engineering and Environmental Laboratory (INEEL). Information presented here should be useful to personnel who must know criticality safety basics to perform their assignments safely or to design critically safe equipment or operations. However, the guide's primary target audience is fissile material handler candidates.

  4. [The results of Russian multicenter open-label observational study of the efficacy and safety of мelaxen (melatonin) for the treatment of disordered sleep in patients with chronic cerebral ischemia].

    PubMed

    Poluéktov, M G; Levin, Ia I; Boĭko, A N; Skoromets, A A; Bel'skaia, G N; Gustov, A V; Doronin, B M; Poverennova, I E; Spirin, N N; Iakupov, E Z

    2012-01-01

    The results of the multicenter open-label observational study of the efficacy and safety of the Melaxen (melatonin) for the treatment of disordered sleep in patients with chronic cerebral ischemia are presented. 2062 patients were studied with the use of subjective psychometric scales: subjective sleep characteristics scale, sleep apnea screening questionnaire, Epworth sleepiness scale, hospital anxiety and depression scale. Mean age of patients was 55.7±9.0 years, there were 74.1% females and 25.9% males. Melaxen was given in dosage of 3 mg. before sleep for 24 days. The use of Melaxen leads to the increase of subjective sleep quality by the subjective sleep characteristics scale from 19.7±3.1 points to и 22.7±3.4 points on day 14 and 22.7±3.4 on day 24 (differences are significant at p<0.0001). There was the decrease of the relative number of patients with frequent night awakenings, prolonged sleep latency, short night sleep, poor quality of morning awakening and multiple bothering dreams. Authors conclude that the use of Melaxen in dosage of 3 mg before sleep is effective and safe insomnia treatment in patients with chronic cerebral ischemia. PMID:23235408

  5. Behavior-based safety on construction sites: a case study.

    PubMed

    Choudhry, Rafiq M

    2014-09-01

    This work presents the results of a case study and describes an important area within the field of construction safety management, namely behavior-based safety (BBS). This paper adopts and develops a management approach for safety improvements in construction site environments. A rigorous behavioral safety system and its intervention program was implemented and deployed on target construction sites. After taking a few weeks of safety behavior measurements, the project management team implemented the designed intervention and measurements were taken. Goal-setting sessions were arranged on-site with workers' participation to set realistic and attainable targets of performance. Safety performance measurements continued and the levels of performance and the targets were presented on feedback charts. Supervisors were asked to give workers recognition and praise when they acted safely or improved critical behaviors. Observers were requested to have discussions with workers, visit the site, distribute training materials to workers, and provide feedback to crews and display charts. They were required to talk to operatives in the presence of line managers. It was necessary to develop awareness and understanding of what was being measured. In the process, operatives learned how to act safely when conducting site tasks using the designed checklists. Current weekly scores were discussed in the weekly safety meetings and other operational site meetings with emphasis on how to achieve set targets. The reliability of the safety performance measures taken by the company's observers was monitored. A clear increase in safety performance level was achieved across all categories: personal protective equipment; housekeeping; access to heights; plant and equipment, and scaffolding. The research reveals that scores of safety performance at one project improved from 86% (at the end of 3rd week) to 92.9% during the 9th week. The results of intervention demonstrated large decreases in

  6. Efficacy and safety of natalizumab in multiple sclerosis: interim observational programme results

    PubMed Central

    Butzkueven, Helmut; Kappos, Ludwig; Pellegrini, Fabio; Trojano, Maria; Wiendl, Heinz; Patel, Radhika N; Zhang, Annie; Hotermans, Christophe; Belachew, Shibeshih

    2014-01-01

    Background Clinical trials established the efficacy and safety of natalizumab. Data are needed over longer periods of time and in the clinical practice setting. Objective To evaluate long-term safety of natalizumab and its impact on annualised relapse rate and Expanded Disability Status Scale (EDSS) progression in patients with relapsing-remitting multiple sclerosis (RRMS). Methods The Tysabri (natalizumab) Observational Program (TOP) is an open-label, multinational, 10-year prospective study in clinical practice settings. Results In this 5-year interim analysis, 4821 patients were enrolled. Follow-up for at least 4 years from natalizumab commencement in 468 patients and at least 2 years in 2496 patients revealed no new safety signals. There were 18 cases of progressive multifocal leucoencephalopathy reported, following 11–44 natalizumab infusions. Mean annualised relapse rate decreased from 1.99 in the 12 months prior to baseline to 0.31 on natalizumab therapy (p<0.0001), remaining low at 5 years. Lower annualised relapse rates were observed in patients who used natalizumab as first MS therapy, in patients with lower baseline EDSS scores, and in patients with lower prenatalizumab relapse rates. Mean EDSS scores remained unchanged up to 5 years. Conclusions Interim TOP data confirm natalizumab's overall safety profile and the low relapse rate and stabilised disability levels in natalizumab-treated patients with RRMS in clinical practice. Trial registration number NCT00493298. PMID:24532785

  7. Study Abroad Programs: Making Safety a Priority

    ERIC Educational Resources Information Center

    Buddan, Michael Craig; Budden, Connie B.; Juban, Rusty; Baraya, Aristides

    2014-01-01

    Increasingly, students are participating in study abroad programs. Such programs provide participants a variety of learning experiences. Developing cross-cultural appreciation, communication skills, maturity and a less ethno-centric mindset are among the impacts study abroad programs offer. However, care must be taken to assure student safety and…

  8. An observational efficacy and safety analysis of the treatment of acute invasive aspergillosis using voriconazole.

    PubMed

    Jacobs, F; Selleslag, D; Aoun, M; Sonet, A; Gadisseur, A

    2012-06-01

    The purpose of this study was to evaluate efficacy and safety of voriconazole in patients with acute invasive aspergillosis (IA) in a real-life, clinical setting. This was a multicenter observational study in adult patients treated with voriconazole for invasive mycosis. The study evaluated clinical response, mortality, use of other licensed antifungal therapy (OLAT), and treatment duration. This sub-analysis evaluated treatment and outcome data specifically from adult patients with proven/probable IA, while safety data were assessed in patients with proven/probable/possible IA. Of the 141 patients enrolled, 113 were adults with proven/probable IA and six had possible IA. Voriconazole treatment duration ranged from 1 to 183 days (median, 49.5 days). Voriconazole was used exclusively in 64% (72/113) of patients and in combination/sequentially with OLAT in 36%. Overall successful treatment response was 50% (57/113 patients). Twelve percent (14/113) of patients were switched to OLAT, either because of insufficient response (four patients) or for safety reasons (10 patients). Overall and attributable (entirely or partially due to fungal infection) mortality rates were 52% (59/113) and 17%, respectively. Treatment-related adverse events were reported for 18% (22/119) of patients. This observational study confirms the results of previous clinical trials demonstrating voriconazole as an effective and safe agent for treatment of confirmed acute IA. PMID:21971820

  9. Fusion reactor breeder material safety compatibility studies

    SciTech Connect

    Jeppson, D.W.; Cohen, S.; Muhlestein, L.D.

    1983-09-01

    Tritium breeder material selection for fusion reactors is strongly influenced by the desire to minimize safety and environmental concerns. Breeder material safety compatibility studies are being conducted to identify and characterize breeder-coolant-material interactions under postulated reactor accident conditions. Recently completed scoping compatibility tests indicate the following. 1. Ternary oxides (LiAlO/sub 2/, Li/sub 2/ZrO/sub 3/, Li/sub 2/SiO/sub 3/, Li/sub 4/SiO/sub 4/, and LiTiO/sub 3/) at postulated blanket operating temperatures are chemically compatible with water coolant, while liquid lithium and Li/sub 7/Pb/sub 2/ reactions with water generate heat, aerosol, and hydrogen. 2. Lithium oxide and 17Li-83Pb alloy react mildly with water requiring special precautions to control hydrogen release. 3. Liquid lithium reacts substantially, while 17Li83Pb alloy reacts mildly with concrete to produce hydrogen. 4. Liquid lithium-air reactions may present some major safety concerns. Additional scoping tests are needed, but the ternary oxides, lithium oxide, and 17Li-83Pb have definite safety advantages over liquid lithium and Li/sub 7/Pb/sub 2/. The ternary oxides present minimal safetyrelated problems when used with water as coolant, air or concrete; but they do require neutron multipliers, which may have safety compatibility concerns with surrounding materials. The combined favorable neutronics and minor safety compatibility concerns of lithium oxide and 17Li-83Pb make them prime candidates as breeder materials. Current safety efforts are directed toward assessing the compatibility of lithium oxide and the lithium-lead alloy with coolants and other materials.

  10. Work stress and patient safety: observer-rated work stressors as predictors of characteristics of safety-related events reported by young nurses.

    PubMed

    Elfering, A; Semmer, N K; Grebner, S

    This study investigates the link between workplace stress and the 'non-singularity' of patient safety-related incidents in the hospital setting. Over a period of 2 working weeks 23 young nurses from 19 hospitals in Switzerland documented 314 daily stressful events using a self-observation method (pocket diaries); 62 events were related to patient safety. Familiarity of safety-related events and probability of recurrence, as indicators of non-singularity, were the dependent variables in multilevel regression analyses. Predictor variables were both situational (self-reported situational control, safety compliance) and chronic variables (job stressors such as time pressure, or concentration demands and job control). Chronic work characteristics were rated by trained observers. The most frequent safety-related stressful events included incomplete or incorrect documentation (40.3%), medication errors (near misses 21%), delays in delivery of patient care (9.7%), and violent patients (9.7%). Familiarity of events and probability of recurrence were significantly predicted by chronic job stressors and low job control in multilevel regression analyses. Job stressors and low job control were shown to be risk factors for patient safety. The results suggest that job redesign to enhance job control and decrease job stressors may be an important intervention to increase patient safety. PMID:16717004

  11. Developing a culture of safety in the epilepsy monitoring unit: a retrospective study of safety outcomes.

    PubMed

    Spanaki, Marianna V; McCloskey, Cathleen; Remedio, Virginia; Budzyn, D; Guanio, Joanne; Monroe, Traci; Barkley, Gregory L; Schultz, Lonni

    2012-10-01

    This study retrospectively reviewed 971 consecutive admissions to our epilepsy monitoring unit (EMU) from July 2007 to May 2011 to compare falls and missed seizures before and after implementing stricter safety processes in May 2009. New safety processes included enhanced staff education, a falls prevention signed contract with patient/family, observation of video-EEG monitors only by EEG technologists, hourly nurse rounding, standby assistance for hygiene needs, and immediate review of adverse events. Wilcoxon's two-sample tests were used for statistical analysis of the two groups. Reduced events between pre-intervention (492 patients) and post-intervention (479 patients) were significant for missed seizures (26 pre- vs 6 post-intervention, p=0.009) but not for falls (12 pre- vs 7 post-intervention, p=0.694). Intensive safety efforts in the EMU produced a 15% reduction in the fall rate per 1000 patient days and a 77% decrease in missed seizures. This study shows stricter safety processes help improve EMU patient safety. PMID:23032129

  12. Study on Running Safety with Gauge Widening

    NASA Astrophysics Data System (ADS)

    Adachi, Masakazu; Sato, Yasuhiro; Ohno, Hiroyuki; Matsumoto, Akira; Iwamoto, Atsushi; Kobayashi, Minoru

    Gauge widening has been set in order that rolling stock runs safely and smoothly on curved tracks. Recently gauge widening has been reduced due to the change of vehicle structures and track maintenance. The reduction of gauge widening may lead the decrease of steering ability of wheelsets and running safety of vehicles. The purpose of this study is to grasp curving performance and running safety when gauge widening was varied. Stand tests were carried out by a bogie test stand, and the authors concluded that the curving performance can be increased according to gauge widening, but the effect is limited in perfect rolling region, and not so effective for normal setting range.

  13. Molten salt safety study. Final report

    SciTech Connect

    Not Available

    1980-01-01

    The considerations concerning safety in using molten salt (40% potassium nitrate, 60% sodium nitrate) in a solar central receiver plant are addressed. The considerations are of a general nature and do not cover any details of equipment or plant operation. The study includes salt chemical reaction, experiments with molten salt, dry storage and handling constraints, and includes data from the National Fire Protection Association. The contents of this report were evaluated by two utility companies and they concluded that no major safety problems exist in using a molten salt solar system.

  14. Organic Tanks Safety Program: Waste aging studies

    SciTech Connect

    Camaioni, D.M.; Samuels, W.D.; Lenihan, B.D.; Clauss, S.A.; Wahl, K.L.; Campbell, J.A.

    1994-11-01

    The underground storage tanks at the Hanford Complex contain wastes generated from many years of plutonium production and recovery processes, and mixed wastes from radiological degradation processes. The chemical changes of the organic materials used in the extraction processes have a direct on several specific safety issues, including potential energy releases from these tanks. This report details the first year`s findings of a study charged with determining how thermal and radiological processes may change the composition of organic compounds disposed to the tank. Their approach relies on literature precedent, experiments with simulated waste, and studies of model reactions. During the past year, efforts have focused on the global reaction kinetics of a simulated waste exposed to {gamma} radiation, the reactions of organic radicals with nitrite ion, and the decomposition reactions of nitro compounds. In experiments with an organic tank non-radioactive simulant, the authors found that gas production is predominantly radiolytically induced. Concurrent with gas generation they observe the disappearance of EDTA, TBP, DBP and hexone. In the absence of radiolysis, the TBP readily saponifies in the basic medium, but decomposition of the other compounds required radiolysis. Key organic intermediates in the model are C-N bonded compounds such as oximes. As discussed in the report, oximes and nitro compounds decompose in strong base to yield aldehydes, ketones and carboxylic acids (from nitriles). Certain aldehydes can react in the absence of radiolysis to form H{sub 2}. Thus, if the pathways are correct, then organic compounds reacting via these pathways are oxidizing to lower energy content. 75 refs.

  15. Studies on Labour Safety in Construction Sites

    PubMed Central

    Kanchana, S.; Sivaprakash, P.; Joseph, Sebastian

    2015-01-01

    Construction industry has accomplished extensive growth worldwide particularly in past few decades. For a construction project to be successful, safety of the structures as well as that of the personnel is of utmost importance. The safety issues are to be considered right from the design stage till the completion and handing over of the structure. Construction industry employs skilled and unskilled labourers subject to construction site accidents and health risks. A proper coordination between contractors, clients, and workforce is needed for safe work conditions which are very much lacking in Indian construction companies. Though labour safety laws are available, the numerous accidents taking place at construction sites are continuing. Management commitment towards health and safety of the workers is also lagging. A detailed literature study was carried out to understand the causes of accidents, preventive measures, and development of safe work environment. This paper presents the results of a questionnaire survey, which was distributed among various categories of construction workers in Kerala region. The paper examines and discusses in detail the total working hours, work shifts, nativity of the workers, number of accidents, and type of injuries taking place in small and large construction sites. PMID:26839916

  16. Studies on Labour Safety in Construction Sites.

    PubMed

    Kanchana, S; Sivaprakash, P; Joseph, Sebastian

    2015-01-01

    Construction industry has accomplished extensive growth worldwide particularly in past few decades. For a construction project to be successful, safety of the structures as well as that of the personnel is of utmost importance. The safety issues are to be considered right from the design stage till the completion and handing over of the structure. Construction industry employs skilled and unskilled labourers subject to construction site accidents and health risks. A proper coordination between contractors, clients, and workforce is needed for safe work conditions which are very much lacking in Indian construction companies. Though labour safety laws are available, the numerous accidents taking place at construction sites are continuing. Management commitment towards health and safety of the workers is also lagging. A detailed literature study was carried out to understand the causes of accidents, preventive measures, and development of safe work environment. This paper presents the results of a questionnaire survey, which was distributed among various categories of construction workers in Kerala region. The paper examines and discusses in detail the total working hours, work shifts, nativity of the workers, number of accidents, and type of injuries taking place in small and large construction sites. PMID:26839916

  17. The effects of error management climate and safety communication on safety: a multi-level study.

    PubMed

    Cigularov, Konstantin P; Chen, Peter Y; Rosecrance, John

    2010-09-01

    Work in the construction industry is considered inherently dangerous, despite the technological improvements regarding the safety of work conditions and equipment. To address the urgent need to identify organizational predictors of safety performance and outcomes among construction workers, the present study examined multi-level effects of two important indicators of safety climate, namely contractor error management climate and worker safety communication, on safety behavior, injury, and pain among union construction workers. Data were collected from 235 union construction workers employed by 15 contractors in Midwest and Northwest regions of the United States. Results revealed significant main effects for safety communication and error management climate on safety behaviors and pain, but not on injuries. Our findings suggest that positive safety communication and error management climate are important contributors to improving workplace safety. Specific implications of these results for organizational safety research and practice are discussed. PMID:20538106

  18. Perceived versus Observed Patient Safety Measures in a Critical Care Unit from a Teaching Hospital in Southern Colombia

    PubMed Central

    Montenegro, Jorge Hernan; Romero, Adriana Fernanda; Tejada, Paola Andrea; Olaya, Sandra Ximena; Rubiano, Andres Mariano

    2016-01-01

    Introduction. Patient safety is an important topic. The purpose of this study is to evaluate the perceived versus observed patient safety measures (PSM) in critically ill patients in a teaching hospital in Latin America. Materials and Methods. The level of perceived patient safety was evaluated with the patient safety hospital survey. Three months later, a qualitative study was conducted, including video recording of procedures, graded according to adherence to PSM. Levels of adherence were scored during patient mobilization (PM), placement of central catheters (PCC), other invasive procedures (OIP), infection control (IC), and endotracheal intubation (ETI). Results. The perceived adherence of PSM in the prestudy survey was considered fair by 89.1% of the ICU staff. After the survey, 829 ICU procedures were video-recorded. Mean observed adherence for fair patient safety measures was 20.8%. Perceived adherence was higher than the real patient safety protocol measures observed in the videos. Conclusion. Perception of PSM was higher than observed in the management of critically ill patients in a teaching hospital in southern Colombia. PMID:26989508

  19. Observational Studies: Matching or Regression?

    PubMed

    Brazauskas, Ruta; Logan, Brent R

    2016-03-01

    In observational studies with an aim of assessing treatment effect or comparing groups of patients, several approaches could be used. Often, baseline characteristics of patients may be imbalanced between groups, and adjustments are needed to account for this. It can be accomplished either via appropriate regression modeling or, alternatively, by conducting a matched pairs study. The latter is often chosen because it makes groups appear to be comparable. In this article we considered these 2 options in terms of their ability to detect a treatment effect in time-to-event studies. Our investigation shows that a Cox regression model applied to the entire cohort is often a more powerful tool in detecting treatment effect as compared with a matched study. Real data from a hematopoietic cell transplantation study is used as an example. PMID:26712591

  20. 78 FR 64504 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-29

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH or Institute) Cancellation:...

  1. 77 FR 27776 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-11

    ... HUMAN SERVICES Centers for Disease Control and Prevention Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH) In accordance with section 10(a)(2..., pursuant to Public Law 92-463. Purpose: The Safety and Occupational Health Study Section will...

  2. 76 FR 3908 - Safety and Occupational Health Study Section (SOHSS); National Institute for Occupational Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-21

    ... HUMAN SERVICES Centers for Disease Control and Prevention Safety and Occupational Health Study Section (SOHSS); National Institute for Occupational Safety and Health (NIOSH); Meeting Notice In accordance with...-1403. Purpose: The Safety and Occupational Health Study Section will review, discuss, and...

  3. 75 FR 5333 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-02

    ... HUMAN SERVICES Centers for Disease Control and Prevention Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH) In accordance with section 10(a)(2... Law 92-463. Purpose: The Safety and Occupational Health Study Section will review, discuss,...

  4. 76 FR 52330 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-22

    ... HUMAN SERVICES Centers for Disease Control and Prevention Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH) In accordance with section 10(a)(2... Office, CDC, pursuant to Public Law 92-463. Purpose: The Safety and Occupational Health Study...

  5. 77 FR 4048 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-26

    ... HUMAN SERVICES Centers for Disease Control and Prevention Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health, (NIOSH) In accordance with section 10(a... Office, CDC, pursuant to Public Law 92-463. Purpose: The Safety and Occupational Health Study...

  6. 75 FR 26266 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-11

    ... HUMAN SERVICES Centers for Disease Control and Prevention Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH) In accordance with section 10(a)(2.... Purpose: The Safety and Occupational Health Study Section will review, discuss, and evaluate...

  7. 76 FR 18220 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-01

    ... HUMAN SERVICES Centers for Disease Control and Prevention Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH) In accordance with section 10(a)(2..., pursuant to Public Law 92-463. Purpose: The Safety and Occupational Health Study Section will...

  8. COLD-SAT feasibility study safety analysis

    NASA Technical Reports Server (NTRS)

    Mchenry, Steven T.; Yost, James M.

    1991-01-01

    The Cryogenic On-orbit Liquid Depot-Storage, Acquisition, and Transfer (COLD-SAT) satellite presents some unique safety issues. The feasibility study conducted at NASA-Lewis desired a systems safety program that would be involved from the initial design in order to eliminate and/or control the inherent hazards. Because of this, a hazards analysis method was needed that: (1) identified issues that needed to be addressed for a feasibility assessment; and (2) identified all potential hazards that would need to be controlled and/or eliminated during the detailed design phases. The developed analysis method is presented as well as the results generated for the COLD-SAT system.

  9. Behavioral integrity for safety, priority of safety, psychological safety, and patient safety: a team-level study.

    PubMed

    Leroy, Hannes; Dierynck, Bart; Anseel, Frederik; Simons, Tony; Halbesleben, Jonathon R B; McCaughey, Deirdre; Savage, Grant T; Sels, Luc

    2012-11-01

    This article clarifies how leader behavioral integrity for safety helps solve follower's double bind between adhering to safety protocols and speaking up about mistakes against protocols. Path modeling of survey data in 54 nursing teams showed that head nurse behavioral integrity for safety positively relates to both team priority of safety and psychological safety. In turn, team priority of safety and team psychological safety were, respectively, negatively and positively related with the number of treatment errors that were reported to head nurses. We further demonstrated an interaction effect between team priority of safety and psychological safety on reported errors such that the relationship between team priority of safety and the number of errors was stronger for higher levels of team psychological safety. Finally, we showed that both team priority of safety and team psychological safety mediated the relationship between leader behavioral integrity for safety and reported treatment errors. These results suggest that although adhering to safety protocols and admitting mistakes against those protocols show opposite relations to reported treatment errors, both are important to improving patient safety and both are fostered by leaders who walk their safety talk. PMID:22985115

  10. 78 FR 75922 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-13

    ... HUMAN SERVICES Centers for Disease Control and Prevention Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH or Institute) In accordance with..., Virginia 22314, Telephone: (703) 684-5900, Fax: (703) 684-0653. Purpose: The Safety and Occupational...

  11. 78 FR 24751 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-26

    ... HUMAN SERVICES Centers for Disease Control and Prevention Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH or Institute) In accordance with... Services Office, CDC, pursuant to Public Law 92-463. Purpose: The Safety and Occupational Health...

  12. Small Liquid Metal Cooled Reactor Safety Study

    SciTech Connect

    Minato, A; Ueda, N; Wade, D; Greenspan, E; Brown, N

    2005-11-02

    The Small Liquid Metal Cooled Reactor Safety Study documents results from activities conducted under Small Liquid Metal Fast Reactor Coordination Program (SLMFR-CP) Agreement, January 2004, between the Central Research Institute of the Electric Power Industry (CRIEPI) of Japan and the Lawrence Livermore National Laboratory (LLNL)[1]. Evaluations were completed on topics that are important to the safety of small sodium cooled and lead alloy cooled reactors. CRIEPI investigated approaches for evaluating postulated severe accidents using the CANIS computer code. The methods being developed are improvements on codes such as SAS 4A used in the US to analyze sodium cooled reactors and they depend on calibration using safety testing of metal fuel that has been completed in the TREAT facility. The 4S and the small lead cooled reactors in the US are being designed to preclude core disruption from all mechanistic scenarios, including selected unprotected transients. However, postulated core disruption is being evaluated to support the risk analysis. Argonne National Laboratory and the University of California Berkeley also supported LLNL with evaluation of cores with small positive void worth and core designs that would limit void worth. Assessments were also completed for lead cooled reactors in the following areas: (1) continuing operations with cladding failure, (2) large bubbles passing through the core and (3) recommendations concerning reflector control. The design approach used in the US emphasizes reducing the reactivity in the control mechanisms with core designs that have essentially no, or a very small, reactivity change over the core life. This leads to some positive void worth in the core that is not considered to be safety problem because of the inability to identify scenarios that would lead to voiding of lead. It is also believed that the void worth will not dominate the severe accident analysis. The approach used by 4S requires negative void worth throughout

  13. Observational studies of Saturn's rings

    NASA Technical Reports Server (NTRS)

    Porco, Carolyn C.

    1987-01-01

    Several noteworthy phenomena in Saturn's rings were investigated which have until now received an inadequate amount of attention. Among these are the periodic variation of the spokes in the B ring and eccentric features throughout the rings. One of the major discoveries by Voyager was the existence of eccentric features within the predominantly circular rings of Saturn. Several of these nonaxisymmetric features are narrow elliptical rings which share many characteristics with the rings of Uranus. In recent work, two narrow ringlets were added to the list of eccentric features in the rings of Saturn. Voyager imaging and occultation data are now in hand, as well as image-processing software which allows accurate absolute positional measurements to be made in Voyager imaging data. Work is in progress to re-examine this region of Saturn's rings and to study the possibility of a dynamical interaction between the outer B ring edge, the Huygens ringlet and the nearby Mimas 2:1 resonance. An understanding of the kinematics and dynamics of this region promises to yield important clues to a matter of great interest in both theoretical and observation ring studies.

  14. Mercury contamination study for flight system safety

    NASA Technical Reports Server (NTRS)

    Gorzynski, C. S., Jr.; Maycock, J. N.

    1972-01-01

    The effects and prevention of possible mercury pollution from the failure of solar electric propulsion spacecraft using mercury propellant were studied from tankage loading of post launch trajector injection. During preflight operations and initial flight mode there is little danger of mercury pollution if proper safety precautions are taken. Any spillage on the loading, mating, transportation, or launch pad areas is obvious and can be removed by vacuum cleaning soil and chemical fixing. Mercury spilled on Cape Kennedy ground soil will be chemically complexed and retained by the sandstone subsoil. A cover layer of sand or gravel on spilled mercury which has settled to the bottom of a water body adjacent to the system operation will control and eliminate the formation of toxic organic mercurials. Mercury released into the earth's atmosphere through leakage of a fireball will be diffused to low concentration levels. However, gas phase reactions of mercury with ozone could cause a local ozone depletion and result in serious ecological hazards.

  15. Safety evaluation and confidence intervals when the number of observed events is small or zero.

    PubMed

    Jovanovic, B D; Zalenski, R J

    1997-09-01

    A common objective in many clinical studies is to determine the safety of a diagnostic test or therapeutic intervention. In these evaluations, serious adverse effects are either rare or not encountered. In this setting, the estimation of the confidence interval (CI) for the unknown proportion of adverse events has special importance. When no adverse events are encountered, commonly used approximate methods for calculating CIs cannot be applied, and such information is not commonly reported. Furthermore, when only a few adverse events are encountered, the approximate methods for calculation of CIs can be applied, but are neither appropriate nor accurate. In both situations, CIs should be computed with the use of the exact binomial distribution. We discuss the need for such estimation and provide correct methods and rules of thumb for quick computations of accurate approximations of the 95% and 99.9% CIs when the observed number of adverse events is zero. PMID:9287891

  16. The School Assessment for Environmental Typology (SAfETy): An Observational Measure of the School Environment.

    PubMed

    Bradshaw, Catherine P; Milam, Adam J; Furr-Holden, C Debra M; Johnson, Sarah Lindstrom

    2015-12-01

    School safety is of great concern for prevention researchers, school officials, parents, and students, yet there are a dearth of assessments that have operationalized school safety from an organizational framework using objective tools and measures. Such a tool would be important for deriving unbiased assessments of the school environment, which in turn could be used as an evaluative tool for school violence prevention efforts. The current paper presents a framework for conceptualizing school safety consistent with Crime Prevention through Environmental Design (CPTED) model and social disorganization theory, both of which highlight the importance of context as a driver for adolescents' risk for involvement in substance use and violence. This paper describes the development of a novel observational measure, called the School Assessment for Environmental Typology (SAfETy), which applies CPTED and social disorganizational frameworks to schools to measure eight indicators of school physical and social environment (i.e., disorder, trash, graffiti/vandalism, appearance, illumination, surveillance, ownership, and positive behavioral expectations). Drawing upon data from 58 high schools, we provide preliminary data regarding the validity and reliability of the SAfETy and describe patterns of the school safety indicators. Findings demonstrate the reliability and validity of the SAfETy and are discussed with regard to the prevention of violence in schools. PMID:26296310

  17. Observational Study of Travelers' Diarrhea.

    PubMed

    Meuris

    1995-03-01

    Background: European air travelers returning from Algeria, Egypt, Mexico, Morocco, and Tunisia were interviewed about their experience of travelers' diseases upon arrival in Brussels. Diarrhea was mentioned by 37% of the adults and 27% of the children. These subjects were questioned about the types of measures taken, type and duration of drug treatment (if any), and about duration of diarrhea and side effects experienced. Methods: Final analysis was performed based on 2160 interviews. The largest proportion of diarrhea was reported in the age group 15-24 years (46%). Results: The majority of the 2160 subjects had opted for drug treatment (81%): 927 subjects for loperamide alone, 235 for loperamide in combination with nifuroxazide, and 178 for nifuroxazide alone. Other drugs had been used less frequently. The median time to recovery was 2.4 days with loperamide compared to 3.2 days with nifuroxazide and to 3.4 days for the no-treatment group. Conclusions: A stratification of the results by severity of the diarrhea suggests a rank of antidiarrheal potency as follows: loperamide > nifuroxazide > no-drug treatment. The side effect with the highest incidence was constipation (2.4% with loperamide). (J Travel Med 2:11-15, 1995) Travelers' diarrhea is usually defined as the passage of at least three unformed stools per day or any number of such stools when accompanied by fever, abdominal cramping, or vomiting. The definition may be broadened to include more trivial bowel disturbance.1,2 The duration of this self-limited disease generally is 3 to 5 days. Medical intervention aims at shortening the duration of disease, thus allowing the sufferer to resume his or her usual activities at an early stage. A shortened period of recovery to physical well-being has obvious favorable economic implications if the traveler is on business and may help the maintenance of a desired level of quality of life while a traveler is on holiday. An observational study of various medical

  18. Lessons Learned from JTA Tester Safety Studies

    SciTech Connect

    R. L. Bierbaum

    2001-05-01

    EP401575, Issue C, calls out a requirement to perform safety studies for testers that are used to accept Joint Test Assembly (JTA) product at Pantex (Reference 1). The underlying motivation is to ensure that personnel hazards due to inadvertent initiation of electro-explosive devices (EEDs) during JTA testing are understood and minimized. Studies have been performed on the B61-7/11 JTA, B61-3/4/10 JTA, B83 JTA, and W76 Type 2F testers at Pantex (References 2-5). Each of these studies includes an examination of the relevant Pantex tester as well as the instrumentation and War Reserve (WR) hardware. In performing these analyses, several themes have emerged that could be useful for the Phase 6.3 design efforts for the weapons, the associated instrumentation, and the JTA testers. This report summarizes the lessons learned from these studies. Note that in some cases, the recommendations provided below to enhance safety during JTA testing operations (e.g., adding isolation resistors in the monitoring lines) may result in a reliability degradation or other surety impact. Thus it is important to consider these lessons learned in the context of the overall design and to make tradeoffs in light of the integrated surety objectives. The lessons learned are listed in five different categories, summarized as: (1) Instrumentation considerations; (2) WR design considerations; (3) Tester considerations; (4) Administrative procedures during JTA assembly; and (5) Administrative procedures prior to and during JTA testing. The first three focus on minimizing the probability of inadvertent application of power to EED initiation lines due to component, connector, and assembly failures. The last two describe procedural steps that can be taken at Pantex to either minimize the risk (e.g., by ensuring that tester power supplies cannot supply excessive power to the unit under test) or to mitigate the consequences of unexpected EED initiation (e.g., by instructing test operators to avoid

  19. Observing the work of an urban safety-net psychiatric emergency room: managing the unmanageable

    PubMed Central

    Lincoln, Alisa K.; White, Andrew; Aldsworth, Casandra; Johnson, Peggy; Strunin, Lee

    2010-01-01

    Staff in the psychiatric emergency room (PER) have demanding jobs requiring a complex balance between the needs and safety of the individual and the community, systemic resources, and job responsibilities while providing timely, effective care. Little research exists concerning day-to-day work activities of PER staff, their interaction, and their perceptions of their work. This study explored the work of PER staff and the organisational context of the PER work setting. Observations of staff were conducted in the public spaces of a public urban PER using two observational techniques. The first was designed to measure the types of work activities staff engaged in and the time spent in these work activities (work task data). The second technique was the gathering of observational data by a peripheral-member-researcher (participant observation data). Analyses were conducted of both the work task and participant observation data. Results indicate that most PER staff time is spent in administrative and phone tasks, while less than a third is spent on direct clinical work. Four important issues for PER work were identified: a workload that is unmanageable, managing the unmanageable, bogus referrals and dumping and insurance problems. The PER remains the front-line of the medical and social service systems. Work done in these settings is of critical importance; however little attention is paid to the content and nature of the work. Our study demonstrates that staff of the PER face challenges on many levels as they struggle with the task of working with people presenting in psychiatric and social crisis. PMID:20149148

  20. Efficacy and safety of insulin degludec in Japanese patients with type 1 and type 2 diabetes: 24-week results from the observational study in routine clinical practice.

    PubMed

    Kobuke, Kazuhiro; Yoneda, Masayasu; Nakanishi, Shuhei; Ohno, Haruya; Maeda, Shusaku; Egusa, Genshi

    2016-01-01

    This is first observational prospective study of insulin degludec in routine clinical practice that we evaluated the effect on glycemic control and risk of hypoglycemia in basal-bolus insulin therapy. We found that insulin degludec can maintain glycemic control at a lower insulin dose and frequency of hypoglycemia in type 1 diabetes, while it can improve glycemic control at equally insulin dose in type 2 diabetes. These results mean that insulin degludec is of use in routine clinical practice. PMID:26816606

  1. 77 FR 75633 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-21

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH) In accordance with section 10(a)(2) of the Federal Advisory Committee Act...

  2. 77 FR 51810 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-27

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH) In accordance with section 10(a)(2) of the Federal Advisory Committee Act...

  3. 78 FR 56235 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-12

    ... HUMAN SERVICES Centers for Disease Control and Prevention Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH or Institute) In accordance with... the magnitude of the aggregate health burden associated with occupational injuries and illnesses,...

  4. Validation of a home safety questionnaire used in a series of case-control studies

    PubMed Central

    Watson, Michael; Benford, Penny; Coupland, Carol; Clacy, Rose; Hindmarch, Paul; Majsak-Newman, Gosia; Deave, Toity; Kendrick, Denise

    2014-01-01

    Objective To measure the validity of safety behaviours, safety equipment use and hazards reported on a questionnaire by parents/carers with children aged under 5 years participating in a series of home safety case-control studies. Methods The questionnaire measured safety behaviours, safety equipment use and hazards being used as exposures in five case-control studies. Responses to questions were compared with observations made during a home visit. The researchers making observations were blind to questionnaire responses. Results In total, 162 families participated in the study. Overall agreement between reported and observed values of the safety practices ranged from 48.5% to 97.3%. Only 3 safety practices (stair gate at the top of stairs, stair gate at the bottom of stairs, stairs are carpeted) had substantial agreement based on the κ statistic (k=0.65, 0.72, 0.74, respectively). Sensitivity was high (≥70%) for 19 of the 30 safety practices, and specificity was high (≥70%) for 20 of the 30 practices. Overall for 24 safety practices, a higher proportion of respondents over-reported than under-reported safe practice (negative predictive value>positive predictive value). For six safety practices, a higher proportion of respondents under-reported than over-reported safe practice (negative predictive valuestudy found that the validity of self-reports varied with safety practice. Questions with a high specificity will be useful for practitioners for identifying households who may benefit from home safety interventions and will be useful for researchers as measures of exposures or outcomes. PMID:24591447

  5. An approach using ensemble empirical mode decomposition to remove noise from prototypical observations on dam safety.

    PubMed

    Su, Huaizhi; Li, Hao; Chen, Zhexin; Wen, Zhiping

    2016-01-01

    It is very important for dam safety control to identify reasonably dam behavior according to the prototypical observations on deformation, seepage, stress, etc. However, there are many cases in which the noise corrupts the prototypical observations, and it must be removed from the data. Considering the nonlinear and non-stationary characteristics of data series with signal intermittency, an ensemble empirical mode decomposition (EEMD)-based method is presented to remove noise from prototypical observations on dam safety. Its basic principle and implementation process are discussed. The key parameters and rules, which can adapt the noise removal requirements of prototypical observations on dam safety, are given. The displacement of one actual dam is taken as an example. The noise removal capability of EEMD-based method is assessed. It is indicated that the dam displacement feature can be reflected more clearly by removing noise from prototypical observations on dam displacement. The statistical model, which is built according to noise-removed data series, can provide the more precise forecast for structural behavior. PMID:27330916

  6. Combustion Safety Simplified Test Protocol Field Study

    SciTech Connect

    Brand, L; Cautley, D.; Bohac, D.; Francisco, P.; Shen, L.; Gloss, S.

    2015-11-05

    "9Combustions safety is an important step in the process of upgrading homes for energy efficiency. There are several approaches used by field practitioners, but researchers have indicated that the test procedures in use are complex to implement and provide too many false positives. Field failures often mean that the house is not upgraded until after remediation or not at all, if not include in the program. In this report the PARR and NorthernSTAR DOE Building America Teams provide a simplified test procedure that is easier to implement and should produce fewer false positives. A survey of state weatherization agencies on combustion safety issues, details of a field data collection instrumentation package, summary of data collected over seven months, data analysis and results are included. The project provides several key results. State weatherization agencies do not generally track combustion safety failures, the data from those that do suggest that there is little actual evidence that combustion safety failures due to spillage from non-dryer exhaust are common and that only a very small number of homes are subject to the failures. The project team collected field data on 11 houses in 2015. Of these homes, two houses that demonstrated prolonged and excessive spillage were also the only two with venting systems out of compliance with the National Fuel Gas Code. The remaining homes experienced spillage that only occasionally extended beyond the first minute of operation. Combustion zone depressurization, outdoor temperature, and operation of individual fans all provide statistically significant predictors of spillage.

  7. Study Finds Consumer Food Safety Knowledge Lacking

    ERIC Educational Resources Information Center

    Godwin, Sandria; Coppings, Richard; Speller-Henderson, Leslie; Pearson, Lou

    2005-01-01

    Proper cooling of foods is known to reduce spoilage and help prevent food-borne illnesses. Nonetheless, little is known about consumers' awareness of guidelines regarding appropriate refrigeration of food or their actual refrigeration practices. Focus groups of consumers of common ethnic backgrounds were designed to evaluate food safety knowledge…

  8. Combustion Safety Simplified Test Protocol Field Study

    SciTech Connect

    Brand, L.; Cautley, D.; Bohac, D.; Francisco, P.; Shen, L.; Gloss, S.

    2015-11-01

    Combustions safety is an important step in the process of upgrading homes for energy efficiency. There are several approaches used by field practitioners, but researchers have indicated that the test procedures in use are complex to implement and provide too many false positives. Field failures often mean that the house is not upgraded until after remediation or not at all, if not include in the program. In this report the PARR and NorthernSTAR DOE Building America Teams provide a simplified test procedure that is easier to implement and should produce fewer false positives. A survey of state weatherization agencies on combustion safety issues, details of a field data collection instrumentation package, summary of data collected over seven months, data analysis and results are included. The project team collected field data on 11 houses in 2015.

  9. Patient safety education and baccalaureate nursing students' patient safety competency: A cross-sectional study.

    PubMed

    Lee, Nam-Ju; Jang, Haena; Park, Su-Yeon

    2016-06-01

    This cross-sectional study examines baccalaureate nursing programs in South Korea to determine how and to what extent patient safety education was delivered, and to assess nursing students' patient safety competency. The Quality and Safety Education for Nurses (QSEN) student evaluation survey and a Patient Safety Competency Self-Evaluation tool were used. We distributed 234 surveys to senior students in four nursing schools; 206 (88%) students responded to the survey. The majority of students (81.6%) reported that they had received patient safety education during coursework. Patient safety education was delivered primarily by lecture rather than during laboratory or simulation sessions. The degree of coverage of QSEN competency and the students' self-reported competency in total and attitude scores showed statistical differences among nursing schools. Students' attitude score was significantly higher than skill and knowledge. Our results confirm the need to revise the nursing curriculum and to use various teaching methods to deliver patient safety education more comprehensively and effectively. Furthermore, there is a need to develop an integrated approach to ensuring students' balanced competency. PMID:26306563

  10. National Traffic Safety Documentation Center Project Definition Study. Final Report.

    ERIC Educational Resources Information Center

    System Development Corp., Falls Church, VA.

    A project definition study was conducted for the development, implementation and operation of a National Traffic Safety Documentation Center. Included in this final comprehensive report are: (1) the results of nationwide surveys of users and sources of traffic safety information; (2) a review of relevant information technology in terms of the…

  11. Age and Workers' Perceptions of Workplace Safety: A Comparative Study

    ERIC Educational Resources Information Center

    Gyekye, Seth Ayim; Salminen, Simo

    2009-01-01

    The study examined the relationship between age and I) safety perception; ii) job satisfaction; iii) compliance with safety management policies; and (iv) accident frequency. Participants were Ghanaian industrial workers (N = 320) categorized into 4 age groups: 19-29 years; 30-39 years; 40-50 years; and 51 years and above. Workplace safety…

  12. A long-term, observational cohort study on the safety of low-dose glucocorticoids in ankylosing spondylitis: adverse events and effects on bone mineral density, blood lipid and glucose levels and body mass index

    PubMed Central

    Zhang, Yu-Ping; Gong, Yao; Zeng, Qing Yu; Hou, Zhi-Duo; Xiao, Zheng-Yu

    2015-01-01

    Objectives This study aimed to investigate the risk of adverse events and effects on bone mineral density (BMD), blood lipid and glucose levels and body mass index (BMI) of low-dose glucocorticoid (GC) treatment in ankylosing spondylitis. Design We performed a retrospective, observational cohort study. Adverse effects were compared between GC users and non-GC users, and we analysed differences in the duration of GC exposure (no GC exposure, <6 months, 6 months to 2 years and >2 years). Setting Outpatient clinic in a tertiary general hospital in China, rheumatology follow-up visits over the past 30 years. Participants We included 830 patients with ankylosing spondylitis who were followed up for at least 6 months without a previous history or current complications of active gastrointestinal problems, hypertension, psychiatric or mental problems, diabetes mellitus, tuberculosis and hepatitis. The median follow-up time was 1.6 years (range 0.5–15 years, a total of 1801 patient-years). Results A total of 555 (66.9%) patients were treated with low-dose GCs, and the median cumulative duration of GC therapy was 1.3 years (range 0.1–8.5 years). Dermatological incidents, including acne, bruisability and cutaneous infections, were the most common adverse events, with a cumulative incidence rate of 5.4% (22.2 events per 1000 patient-years), followed by a puffy and rounded face (1.6%), symptoms of weight gain (1.1%) and serious infections (1.0%). The rates of all other types of adverse events were less than 1%. The GC groups (GC users and non-GC users) and the duration of GC therapy were not associated with the frequency of low BMD, dyslipidaemia, hyperglycaemia or obesity (p<0.05). Conclusions Adverse events during long-term treatment of low-dose GCs are limited. Low-dose GCs do not have an adverse effect on BMD, blood lipid and glucose levels and BMI. PMID:26041488

  13. Impact of a US Food and Drug Administration Drug Safety Communication on Zolpidem Dosing: An Observational Retrospective Cohort

    PubMed Central

    Harward, Jonathan L.; Clinard, Valerie B.; Jiroutek, Michael R.; Lingerfeldt, Beverly H.

    2015-01-01

    Introduction/background: Zolpidem is a sedative-hypnotic widely prescribed in the United States. Recently, the US Food and Drug Administration (FDA) issued a drug safety communication regarding its dosing in women. Objective: To compare compliance with FDA-approved dosing for zolpidem in women before and after a drug safety communication, and to evaluate compliance based on pharmacy location and prescriber type. Method: This was a retrospective, observational cohort study. New prescriptions for Ambien, Ambien CR, Edluar, or Zolpimist or their respective generics dispensed from Kerr Drug pharmacies in North Carolina to women 18–64 years of age between April and September of 2012 (“before” cohort) or April and September of 2013 (“after” cohort) were included. χ2 tests were conducted to assess overall compliance, as well as compliance based on location (urban or rural) and prescriber type (physician or midlevel), with FDA-approved dosing for zolpidem. Trends in total prescription volume and total zolpidem prescription volume for all Kerr Drug pharmacies over the study period were also described. Results: A total of 14,156 prescriptions for zolpidem were included in the primary analysis. Sixteen percent of prescriptions dispensed were in compliance with FDA recommendations following the FDA alert. A statistically significant increase was observed in compliance with FDA-approved dosing for zolpidem (odds ratio = 1.49; 95% CI, 1.35–1.65; P < .0001) postdrug safety communication. Significant increases in compliance were also observed in the post-FDA communication subgroups based on location and prescriber type, though no subgroup was found to be significantly more compliant than another. Conclusions: The release of a drug safety communication by the FDA resulted in a statistically significant increase in proper dosing of zolpidem in women. Further research is needed in order to determine the impact of FDA alerts on prescribing patterns and the reasons for

  14. Design study on safety protection system of JSFR

    SciTech Connect

    Ishikawa, N.; Chikazawa, Y.; Fujita, K.; Yamada, Y.; Okazaki, H.; Suzuki, S.

    2012-07-01

    Development of Japan Sodium-cooled Fast Reactor (JSFR) has been progressed in Fast Reactor Cycle Technology Development (FaCT) project aiming at realizing high level of safety, reliability and economic competitiveness. For JSFR, design consideration on safety protection system has also been performed, which is essential for reactor shutdown in the case of design basis events (DBEs). In the design activity, consideration of safety protection system includes logic circuits configuration, selection of trip signals, and its setting values for reactor trip. In addition, it is necessary to evaluate the performance of the safety protection system by safety analysis taking into account the comprehensive parameter ranges. For this purpose, it has been evaluated whether adequate reactor trip signals can be ensured for satisfying safety standard regarding the fuel integrity (e.g., maximum fuel clad temperature) for DBEs. In this paper, results obtained from the design study on safety protection system of JSFR is presented focusing on the evaluation results of satisfaction of safety protection system for representative events of transient over power (TOP), loss of coolant flow (LOF) and loss of heat sink (LOHS). (authors)

  15. Study Gives Good Odds on Nuclear Reactor Safety

    ERIC Educational Resources Information Center

    Russell, Cristine

    1974-01-01

    Summarized is data from a recent study on nuclear reactor safety completed by Norman C. Rasmussen and others. Non-nuclear events are about 10,000 times more likely to produce large accidents than nuclear plants. (RH)

  16. POLIOMYELITIS VACCINE—Epidemiologic Observations on the Safety and Effectiveness in California in 1955

    PubMed Central

    Magoffin, Robert L.

    1956-01-01

    During the past year California has participated with other states in a nationwide field evaluation of the safety and effectiveness of poliomyelitis vaccine. Among 227,000 children who received Cutter vaccine, and the household contracts of these children, the incidence of poliomyelitis was higher during the early postvaccinal period than in comparable age groups of the population at large. Among 238,000 children who received poliomyelitis vaccine made by other manufacturers early in 1955 no increase in poliomyelitis was observed in the inoculated children or their household contacts. Subsequent observation on over 500,000 additional children vaccinated in California alone since September 1955 with vaccine that was made under revised safety standards has uncovered no evidence of unsafe vaccine. In children who received a single inoculation of vaccine prior to the onset of the poliomyelitis season in 1955 the incidence of paralytic poliomyelitis was about 60 per cent less than in unvaccinated children. Among those who received two inoculations an 85 per cent reduction was observed. The average reduction in paralytic poliomyelitis for the entire vaccinated group was approximately 75 per cent. Data thus far on children vaccinated since September 1955 with poliomyelitis vaccine made by methods now approved indicate that a similar overall effectiveness is still being maintained. PMID:13343011

  17. Ways of learning: Observational studies versus experiments

    USGS Publications Warehouse

    Shaffer, T.L.; Johnson, D.H.

    2008-01-01

    Manipulative experimentation that features random assignment of treatments, replication, and controls is an effective way to determine causal relationships. Wildlife ecologists, however, often must take a more passive approach to investigating causality. Their observational studies lack one or more of the 3 cornerstones of experimentation: controls, randomization, and replication. Although an observational study can be analyzed similarly to an experiment, one is less certain that the presumed treatment actually caused the observed response. Because the investigator does not actively manipulate the system, the chance that something other than the treatment caused the observed results is increased. We reviewed observational studies and contrasted them with experiments and, to a lesser extent, sample surveys. We identified features that distinguish each method of learning and illustrate or discuss some complications that may arise when analyzing results of observational studies. Findings from observational studies are prone to bias. Investigators can reduce the chance of reaching erroneous conclusions by formulating a priori hypotheses that can be pursued multiple ways and by evaluating the sensitivity of study conclusions to biases of various magnitudes. In the end, however, professional judgment that considers all available evidence is necessary to render a decision regarding causality based on observational studies.

  18. Safety.

    ERIC Educational Resources Information Center

    Education in Science, 1996

    1996-01-01

    Discusses safety issues in science, including: allergic reactions to peanuts used in experiments; explosions in lead/acid batteries; and inspection of pressure vessels, such as pressure cookers or model steam engines. (MKR)

  19. Food safety and older people: the Kitchen Life study.

    PubMed

    Dickinson, Angela; Wills, Wendy; Meah, Angela; Short, Frances

    2014-05-01

    Foodborne illness (FBI) is a major public health problem in the UK. Recent increases in cases of listeriosis in older people have focused attention on consumer food-related practices. Previous studies highlight poor relationships between what people know, what they say they do and what they actually do in the kitchen. The aim of the Kitchen Life study was to examine what actually happens in the domestic kitchen to assess whether and how this has the potential to influence food safety in the home. Drawing on a qualitative ethnographic approach, methods included a kitchen tour, photography, observation, video observation, informal interviews and diary methods. Ten households with older people (aged 60+) were recruited across the UK. It was found that trust in the food supply, use of food-labelling (including use-by dates), sensory logics (such as the feel or smell of food) and food waste were factors with the potential to influence risk of foodborne illness. Practices shifted with changing circumstances, including increased frailty, bereavement, living alone, receiving help with care and acquiring new knowledge, meaning that the risk of and vulnerability to foodborne illness is not straightforward. PMID:24784557

  20. Space Station crew safety alternatives study. Volume 4: Appendices

    NASA Technical Reports Server (NTRS)

    Peercy, R. L., Jr.; Raasch, R. F.; Rockoff, L. A.

    1985-01-01

    The scope of this study considered the first 15 years of accumulated space station concepts for Initial Operational Capability (10C) during the early 1990's. Twenty-five threats to the space station are identified and selected threats addressed as impacting safety criteria, escape and rescue, and human factors safety concerns. Of the 25 threats identified, eight are discussed including strategy options for threat control: fire, biological or toxic contamination, injury/illness, explosion, loss of pressurization, radiation, meteoroid penetration and debris.

  1. CNODES: the Canadian Network for Observational Drug Effect Studies.

    PubMed

    Suissa, Samy; Henry, David; Caetano, Patricia; Dormuth, Colin R; Ernst, Pierre; Hemmelgarn, Brenda; Lelorier, Jacques; Levy, Adrian; Martens, Patricia J; Paterson, J Michael; Platt, Robert W; Sketris, Ingrid; Teare, Gary

    2012-01-01

    Although administrative health care databases have long been used to evaluate adverse drug effects, responses to drug safety signals have been slow and uncoordinated. We describe the establishment of the Canadian Network for Observational Drug Effect Studies (CNODES), a collaborating centre of the Drug Safety and Effectiveness Network (DSEN). CNODES is a distributed network of investigators and linked databases in British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, Quebec and Nova Scotia. Principles of operation are as follows: (1) research questions are prioritized by the coordinating office of DSEN; (2) the linked data stay within the provinces; (3) for each question, a study team formulates a detailed protocol enabling consistent analyses in each province; (4) analyses are "blind" to results obtained elsewhere; (5) protocol deviations are permitted for technical reasons only; (6) analyses using multivariable methods are lodged centrally with a methods team, which is responsible for combining the results to provide a summary estimate of effect. These procedures are designed to achieve high internal validity of risk estimates and to eliminate the possibility of selective reporting of analyses or outcomes. The value of a coordinated multi-provincial approach is illustrated by projects studying acute renal injury with high-potency statins, community-acquired pneumonia with proton pump inhibitors, and hyperglycemic emergencies with antipsychotic drugs. CNODES is an academically based distributed network of Canadian researchers and data centres with a commitment to rapid and sophisticated analysis of emerging drug safety signals in study populations totalling over 40 million. PMID:23687528

  2. Alternatives to hazard ratios for comparing efficacy or safety of therapies in noninferiority studies

    PubMed Central

    Uno, Hajime; Wittes, Janet; Fu, Haoda; Solomon, Scott D.; Claggett, Brian; Tian, Lu; Cai, Tianxi; Pfeffer, Marc A.; Evans, Scott R.; Wei, Lee-Jen

    2015-01-01

    A noninferiority study is often used to investigate whether a treatment’s efficacy or safety profile is acceptable compared to an alternative therapy regarding the time to a clinical event. The empirical quantification of the treatment difference for such a study is routinely based on the hazard ratio estimate. The hazard ratio, which is not a relative risk, may be difficult to interpret clinically, especially when the underlying proportional hazards assumption is violated. The precision of the hazard ratio estimate depends primarily on the number of observed events, but not directly on either exposure times or sample size of the study population. If the event rate is low, the study may require an impractically large number of events to ensure that the prespecified noninferiority criterion for the hazard ratio is attainable. This article discusses deficiencies of the current approach for design and analysis of a noninferiority study. We then provide alternative procedures, which do not depend on any model assumption, to compare two treatments. For a noninferiority safety study, the patients’ exposure times are more clinically important than the observed number of events. If the study patients’ exposure times are long enough to evaluate safety reliably, these alternative procedures can effectively provide clinically interpretable evidence on safety, even with relatively few observed events. We illustrate these procedures with data from two studies. One explores the cardiovascular safety of a pain medicine; the second examines the cardiovascular safety of a new treatment for diabetes. These alternative strategies to evaluate safety or efficacy of an intervention lead to more meaningful interpretations of the analysis results than the conventional one via the hazard ratio estimate. PMID:26054047

  3. Observing Protein & Energy Nutrition (OPEN) Study

    Cancer.gov

    The Observing Protein and Energy Nutrition (OPEN) Study was designed to assess dietary measurement error by comparing results from self-reported dietary intake data with four dietary biomarkers: doubly labeled water and urinary nitrogen, sodium, and potassium.

  4. Community Engagement in Observational Human Exposure Studies

    EPA Science Inventory

    Although observational human exposure studies do not deliberately expose participants to chemicals or environmental conditions, merely involving people as research participants and conducting research inside homes raises ethical issues. Community engagement offers a promising st...

  5. Safety assessment of aditoprim acute, subchronic toxicity and mutagenicity studies.

    PubMed

    Wang, Xu; Tan, Ziqiang; Pan, Yuanhu; Ihsan, Awais; Liu, Qianying; Huang, Lingli; Cheng, Guyue; Chen, Dongmei; Tao, Yanfei; Liu, Zhenli; Yuan, Zonghui

    2015-11-01

    Aditoprim (ADP), a new developed dihydrofolate reductase (DHFR) inhibitor, has great potential in clinical veterinary medicine because of its greater pharmacokinetic properties than structural analogs. Preclinical toxicology studies were performed to assess the safety of ADP including an acute oral toxicity test, a subchronic toxicity test and five mutagenicity tests. In the acute oral toxicity test, ADP was administered singly by oral gavage to Wistar rats and Kunming mice. The LD50 calculated was 1400 mg kg(-1) body weight (BW) day(-1) in rats and 1130 mg kg(-1) BW day(-1) in mice. In a subchronic study, Wistar rats were administered ADP at dose levels of 0, 20, 100 and 1000 mg kg(-1) diet for 90 days. Significant decreases were observed on body weight and food efficiency in the high-dose group. Treatment-related changes in clinical serum biochemistry were found in the medium- and high-dose groups. Significant increases in the relative weights of livers and kidneys in females and testis in males in the 1000 mg kg(-1) diet, and significant decrease in relative weights of livers in males in the 100 mg kg(-1) diet were noted. Histopathological observations revealed that the 1000 mg kg(-1) ADP diet could induce lymphocytic infiltration and hepatocytic necrosis near the hepatic portal area. The genotoxicity of ADP was negative in tests, such as the bacterial reverse mutation assay, mice bone marrow erythrocyte micronucleus assay, in vitro chromosomal aberration test, in vitro cho/hgprt mammalian cell mutagenesis assay and mice testicle cells chromosome aberration. Based on the subchronic study, the no-observed-adverse-effect level for ADP was a 20 mg kg(-1) diet, which is about 1.44-1.53 mg kg(-1) BW day(-1) in rats. PMID:25663419

  6. A Numerical Climate Observing Network Design Study

    NASA Technical Reports Server (NTRS)

    Stammer, Detlef

    2003-01-01

    This project was concerned with three related questions of an optimal design of a climate observing system: 1. The spatial sampling characteristics required from an ARGO system. 2. The degree to which surface observations from ARGO can be used to calibrate and test satellite remote sensing observations of sea surface salinity (SSS) as it is anticipated now. 3. The more general design of an climate observing system as it is required in the near future for CLIVAR in the Atlantic. An important question in implementing an observing system is that of the sampling density required to observe climate-related variations in the ocean. For that purpose this project was concerned with the sampling requirements for the ARGO float system, but investigated also other elements of a climate observing system. As part of this project we studied the horizontal and vertical sampling characteristics of a global ARGO system which is required to make it fully complementary to altimeter data with the goal to capture climate related variations on large spatial scales (less thanAttachment: 1000 km). We addressed this question in the framework of a numerical model study in the North Atlantic with an 1/6 horizontal resolution. The advantage of a numerical design study is the knowledge of the full model state. Sampled by a synthetic float array, model results will therefore allow to test and improve existing deployment strategies with the goal to make the system as optimal and cost-efficient as possible. Attachment: "Optimal observations for variational data assimilation".

  7. [Critical reading of analytical observational studies].

    PubMed

    García Villar, C; Marín León, I

    2015-11-01

    Analytical observational studies provide very important information about real-life clinical practice and the natural history of diseases and can suggest causality. Furthermore, they are very common in scientific journals. The aim of this article is to review the main concepts necessary for the critical reading of articles about radiological studies with observational designs. It reviews the characteristics that case-control and cohort studies must have to ensure high quality. It explains a method of critical reading that involves checking the attributes that should be evaluated in each type of article using a structured list of specific questions. It underlines the main characteristics that confer credibility and confidence on the article evaluated. Readers are provided with tools for the critical analysis of the observational studies published in scientific journals. PMID:26123855

  8. Hypothermia during Carotid Endarterectomy: A Safety Study

    PubMed Central

    Candela, Serena; Dito, Raffaele; Casolla, Barbara; Silvestri, Emanuele; Sette, Giuliano; Filippi, Federico; Taurino, Maurizio; Brancadoro, Domitilla; Orzi, Francesco

    2016-01-01

    Background CEA is associated with peri-operative risk of brain ischemia, due both to emboli production caused by manipulation of the plaque and to potentially noxious reduction of cerebral blood flow by carotid clamping. Mild hypothermia (34–35°C) is probably the most effective approach to protect brain from ischemic insult. It is therefore a substantial hypothesis that hypothermia lowers the risk of ischemic brain damage potentially associated with CEA. Purpose of the study is to test whether systemic endovascular cooling to a target of 34.5–35°C, initiated before and maintained during CEA, is feasible and safe. Methods The study was carried out in 7 consecutive patients referred to the Vascular Surgery Unit and judged eligible for CEA. Cooling was initiated 60–90 min before CEA, by endovascular approach (Zoll system). The target temperature was maintained during CEA, followed by passive, controlled rewarming (0.4°C/h). The whole procedure was carried out under anesthesia. Results All the patients enrolled had no adverse events. Two patients exhibited a transient bradycardia (heart rate 30 beats/min). There were no significant differences in the clinical status, laboratory and physiological data measured before and after CEA. Conclusions Systemic cooling to 34.5–35.0°C, initiated before and maintained during carotid clamping, is feasible and safe. Trial Registration ClinicalTrials.gov NCT02629653 PMID:27058874

  9. Patient safety in Dutch primary care: a study protocol

    PubMed Central

    2010-01-01

    Background Insight into the frequency and seriousness of potentially unsafe situations may be the first step towards improving patient safety. Most patient safety attention has been paid to patient safety in hospitals. However, in many countries, patients receive most of their healthcare in primary care settings. There is little concrete information about patient safety in primary care in the Netherlands. The overall aim of this study was to provide insight into the current patient safety issues in Dutch general practices, out-of-hours primary care centres, general dental practices, midwifery practices, and allied healthcare practices. The objectives of this study are: to determine the frequency, type, impact, and causes of incidents found in the records of primary care patients; to determine the type, impact, and causes of incidents reported by Dutch healthcare professionals; and to provide insight into patient safety management in primary care practices. Design and methods The study consists of three parts: a retrospective patient record study of 1,000 records per practice type was conducted to determine the frequency, type, impact, and causes of incidents found in the records of primary care patients (objective one); a prospective component concerns an incident-reporting study in each of the participating practices, during two successive weeks, to determine the type, impact, and causes of incidents reported by Dutch healthcare professionals (objective two); to provide insight into patient safety management in Dutch primary care practices (objective three), we surveyed organizational and cultural items relating to patient safety. We analysed the incidents found in the retrospective patient record study and the prospective incident-reporting study by type of incident, causes (Eindhoven Classification Model), actual harm (severity-of-outcome domain of the International Taxonomy of Medical Errors in Primary Care), and probability of severe harm or death. Discussion

  10. [Study of post marketing safety reevaluation of shenqi fuzheng injection].

    PubMed

    Ai, Qing-Hua; Li, Yuan-Yuan; Xie, Yan-Ming

    2014-09-01

    In order to promote the Shenqifuzheng injection (SQFZ) clinical medication safety, this study reevaluate on SQFZ post marketing safety study systematically. Including multi center large sample registration type safety monitoring research, the analysis based on national spontaneous reporting system data, the analysis based on the 20 national hospital information system data and literature research. Above the analysis, it suggests that SQFZ has good security. The more adverse drug reaction (ADR) as allergic reactions, mainly involved in the damage of skin, appendages and its systemic damage, serious person can appear allergic shock. ADR/E is more common in the elderly, may be related to medication (tumor) populations. Early warning analysis based on SRS data and literature research are of the view that "phlebitis" has a strong association with SQFZ used. PMID:25532410

  11. Embedding clinical interventions into observational studies.

    PubMed

    Newman, Anne B; Avilés-Santa, M Larissa; Anderson, Garnet; Heiss, Gerardo; Howard, Wm James; Krucoff, Mitchell; Kuller, Lewis H; Lewis, Cora E; Robinson, Jennifer G; Taylor, Herman; Treviño, Roberto P; Weintraub, William

    2016-01-01

    Novel approaches to observational studies and clinical trials could improve the cost-effectiveness and speed of translation of research. Hybrid designs that combine elements of clinical trials with observational registries or cohort studies should be considered as part of a long-term strategy to transform clinical trials and epidemiology, adapting to the opportunities of big data and the challenges of constrained budgets. Important considerations include study aims, timing, breadth and depth of the existing infrastructure that can be leveraged, participant burden, likely participation rate and available sample size in the cohort, required sample size for the trial, and investigator expertise. Community engagement and stakeholder (including study participants) support are essential for these efforts to succeed. PMID:26611435

  12. Observational Studies of Transiting Extrasolar Planets

    NASA Astrophysics Data System (ADS)

    Southworth, J.

    2015-07-01

    The study of transiting extrasolar planets is only 15 years old, but has matured into a rich area of research. I review the observational aspects of this work, concentrating on the discovery of transits, the characterization of planets from photometry and spectroscopy, the Homogeneous Studies project, starspots, orbital obliquities, and the atmospheric properties of the known planets. I begin with historical context and conclude with a glance to a future of TESS, CHEOPS, Gaia and PLATO.

  13. Acyclovir in pityriasis rosea: An observer-blind, randomized controlled trial of effectiveness, safety and tolerability

    PubMed Central

    Das, Anupam; Sil, Amrita; Das, Nilay Kanti; Roy, Kunal; Das, Amal Kanti; Bandyopadhyay, Debabrata

    2015-01-01

    Background: Pityriasis rosea (PR) is an acute inflammatory dermatosis. The association of human herpes virus 6 and 7 suggests the utility of use of antiviral agents in this disease. Aims and Objectives: To evaluate the effectiveness and safety of acyclovir in the treatment of PR. Methods: An observer-blind, randomized (1:1), parallel group, add-on trial was conducted on 24 adult patients with PR. Subjects of both Group A and B received the standard of care in the form of cetirizine 10 mg OD and calamine. Group A in addition received acyclovir 400 mg tablets thrice daily for 7 days. Both groups were followed up for four consecutive weeks for assessment of effectiveness and adverse events. Results: Group A complained of significantly fewer new lesions than Group B (P = 0.046). A complete response was obtained in all patients of Group A and 83% patients of Group B at the end of the follow up period. There was significant reduction in both lesional score and pruritus at second week follow-up in Group A and third week follow-up in Group B (P < 0.05). Minor adverse effects were observed in both treatment arms. Conclusion: Acyclovir offered rapid resolution of clinical severity of PR from second week onwards without significantly increased adverse events as compared to supportive therapy alone. PMID:26009712

  14. Total Diet Studies as a Tool for Ensuring Food Safety

    PubMed Central

    Lee, Joon-Goo; Kim, Sheen-Hee; Kim, Hae-Jung

    2015-01-01

    With the diversification and internationalization of the food industry and the increased focus on health from a majority of consumers, food safety policies are being implemented based on scientific evidence. Risk analysis represents the most useful scientific approach for making food safety decisions. Total diet study (TDS) is often used as a risk assessment tool to evaluate exposure to hazardous elements. Many countries perform TDSs to screen for chemicals in foods and analyze exposure trends to hazardous elements. TDSs differ from traditional food monitoring in two major aspects: chemicals are analyzed in food in the form in which it will be consumed and it is cost-effective in analyzing composite samples after processing multiple ingredients together. In Korea, TDSs have been conducted to estimate dietary intakes of heavy metals, pesticides, mycotoxins, persistent organic pollutants, and processing contaminants. TDSs need to be carried out periodically to ensure food safety. PMID:26483881

  15. Ensuring Safety and Security for Avionics: A Case Study

    NASA Astrophysics Data System (ADS)

    Laarouchi, Y.; Deswarte, Y.; Powell, D.; Arlat, J.; De Nadai, E.

    2009-05-01

    We present a case study in the avionics context, in which bidirectional information flows exist between critical components and less critical ones. These flows raise security and safety concerns that have to be taken into account to guarantee correct operation of the critical tasks. To allow upwards flows, we propose fault tolerance mechanisms based on diverse operating systems isolated by virtualization.

  16. Safety Hazards in Child Care Settings. CPSC Staff Study.

    ERIC Educational Resources Information Center

    Consumer Product Safety Commission, Washington, DC.

    Each year, thousands of children in child care settings are injured seriously enough to need emergency medical treatment. This national study identified potential safety hazards in 220 licensed child care settings in October and November 1998. Eight product areas were examined: cribs, soft bedding, playground surfacing, playground surface…

  17. Alaska Humans Factors Safety Study: The Southern Coastal Area

    NASA Technical Reports Server (NTRS)

    Chappell, Sheryl L.; Reynard, William (Technical Monitor)

    1995-01-01

    At the request of the Alaska Air Carriers Association, researchers from the NASA Aviation Safety Reporting System, at NASA Ames Research Center, conducted a study on aspects of safety in Alaskan Part 135 air taxi operations. An interview form on human factors safety issues was created by a representative team from the FAA-Alaska, NTSB-Alaska, NASA-ASRS, and representatives of the Alaska Air Carriers Association which was subsequently used in the interviews of pilots and managers. Because of the climate and operational differences, the study was broken into two geographical areas, the southern coastal areas and the northern portion of the state. This presentation addresses the southern coastal areas, specifically: Anchorage, Dillingham, King Salmon, Kodiak, Cold Bay, Juneau, and Ketchikan. The interview questions dealt with many of the potential pressures on pilots and managers associated with the daily air taxi operations in Alaska. The impact of the environmental factors such as the lack of available communication, navigation and weather information systems was evaluated. The results of this study will be used by government and industry working in Alaska. These findings will contribute important information on specific Alaska safety issues for eventual incorporation into training materials and policies that will help to assure the safe conduct of air taxi flights in Alaska.

  18. Alaska Humans Factors Safety Study: The Northern Area

    NASA Technical Reports Server (NTRS)

    Connell, Linda; Reynard, William (Technical Monitor)

    1995-01-01

    At the request of the Alaska Air Carriers Association, researchers from the NASA Aviation Safety Reporting System, at NASA Ames Research Center, conducted a study on aspects of safety in Alaskan Part 135 air taxi operations. An interview form on human factors safety issues was created by a representative team from the FAA-Alaska, NTSB-Alaska, NASAASRS, and representatives of the Alaska Air Carriers Association which was subsequently used in the interviews of pilots and managers. Because of the climate and operational differences, the study was broken into two geographical areas, the southern coastal areas and the northern portion of the state. This presentation addresses the northern area, specifically: Bethel, Fairbanks, Nome, Kotzebue, and Barrow. The interview questions dealt with many of the potential pressures on pilots and managers associated with the daily air taxi operations in Alaska. The impact of the environmental factors such as the lack of available communication, navigation and weather information systems was evaluated. The results of this study will be used by government and industry working in Alaska. These findings will contribute important information on specific Alaska safety issues for eventual incorporation into training materials and policies that will help to assure the safe conduct of air taxi flights in Alaska.

  19. A study on drug safety monitoring program in India.

    PubMed

    Ahmad, A; Patel, Isha; Sanyal, Sudeepa; Balkrishnan, R; Mohanta, G P

    2014-09-01

    Pharmacovigilance is useful in assuring the safety of medicines and protecting the consumers from their harmful effects. A number of single drugs as well as fixed dose combinations have been banned from manufacturing, marketing and distribution in India. An important issue about the availability of banned drugs over the counter in India is that sufficient adverse drug reactions data about these drugs have not been reported. The most common categories of drugs withdrawn in the last decade were nonsteroidal antiinflammatory drugs (28%), antidiabetics (14.28%), antiobesity (14.28%), antihistamines (14.28%), gastroprokinetic drugs (7.14%), breast cancer and infertility drugs (7.14%), irritable bowel syndrome and constipation drugs (7.14%) and antibiotics (7.14%). Drug withdrawals from market were made mainly due to safety issues involving cardiovascular events (57.14%) and liver damage (14.28%). Majority of drugs have been banned since 3-5 years in other countries but are still available for sale in India. The present study compares the drug safety monitoring systems in the developed countries such as the USA and UK and provides implications for developing a system that can ensure the safety and efficacy of drugs in India. Absence of a gold standard for a drug safety surveillance system, variations in culture and clinical practice across countries makes it difficult for India to completely adopt another country's practices. There should be a multidisciplinary approach towards drug safety that should be implemented throughout the entire duration spanning from drug discovery to usage by consumers. PMID:25425751

  20. A Study on Drug Safety Monitoring Program in India

    PubMed Central

    Ahmad, A.; Patel, Isha; Sanyal, Sudeepa; Balkrishnan, R.; Mohanta, G. P.

    2014-01-01

    Pharmacovigilance is useful in assuring the safety of medicines and protecting the consumers from their harmful effects. A number of single drugs as well as fixed dose combinations have been banned from manufacturing, marketing and distribution in India. An important issue about the availability of banned drugs over the counter in India is that sufficient adverse drug reactions data about these drugs have not been reported. The most common categories of drugs withdrawn in the last decade were nonsteroidal antiinflammatory drugs (28%), antidiabetics (14.28%), antiobesity (14.28%), antihistamines (14.28%), gastroprokinetic drugs (7.14%), breast cancer and infertility drugs (7.14%), irritable bowel syndrome and constipation drugs (7.14%) and antibiotics (7.14%). Drug withdrawals from market were made mainly due to safety issues involving cardiovascular events (57.14%) and liver damage (14.28%). Majority of drugs have been banned since 3-5 years in other countries but are still available for sale in India. The present study compares the drug safety monitoring systems in the developed countries such as the USA and UK and provides implications for developing a system that can ensure the safety and efficacy of drugs in India. Absence of a gold standard for a drug safety surveillance system, variations in culture and clinical practice across countries makes it difficult for India to completely adopt another country's practices. There should be a multidisciplinary approach towards drug safety that should be implemented throughout the entire duration spanning from drug discovery to usage by consumers. PMID:25425751

  1. Ozone Lidar Observations for Air Quality Studies

    NASA Technical Reports Server (NTRS)

    Wang, Lihua; Newchurch, Mike; Kuang, Shi; Burris, John F.; Huang, Guanyu; Pour-Biazar, Arastoo; Koshak, William; Follette-Cook, Melanie B.; Pickering, Kenneth E.; McGee, Thomas J.; Sullivan, John T.; Langford, Andrew O.; Senff, Christoph J.; Alvarez, Raul; Eloranta, Edwin

    2015-01-01

    Tropospheric ozone lidars are well suited to measuring the high spatio-temporal variability of this important trace gas. Furthermore, lidar measurements in conjunction with balloon soundings, aircraft, and satellite observations provide substantial information about a variety of atmospheric chemical and physical processes. Examples of processes elucidated by ozone-lidar measurements are presented, and modeling studies using WRF-Chem, RAQMS, and DALES/LES models illustrate our current understanding and shortcomings of these processes.

  2. Ferrocyanide safety project ferrocyanide aging studies. Final report

    SciTech Connect

    Lilga, M.A.; Hallen, R.T.; Alderson, E.V.

    1996-06-01

    This final report gives the results of the work conducted by Pacific Northwest National Laboratory (PNNL) from FY 1992 to FY 1996 on the Ferrocyanide Aging Studies, part of the Ferrocyanide Safety Project. The Ferrocyanide Safety Project was initiated as a result of concern raised about the safe storage of ferrocyanide waste intermixed with oxidants, such as nitrate and nitrite salts, in Hanford Site single-shell tanks (SSTs). In the laboratory, such mixtures can be made to undergo uncontrolled or explosive reactions by heating dry reagents to over 200{degrees}C. In 1987, an Environmental Impact Statement (EIS), published by the U.S. Department of Energy (DOE), Final Environmental Impact Statement, Disposal of Hanford Defense High-Level Transuranic and Tank Waste, Hanford Site, Richland, Washington, included an environmental impact analysis of potential explosions involving ferrocyanide-nitrate mixtures. The EIS postulated that an explosion could occur during mechanical retrieval of saltcake or sludge from a ferrocyanide waste tank, and concluded that this worst-case accident could create enough energy to release radioactive material to the atmosphere through ventilation openings, exposing persons offsite to a short-term radiation dose of approximately 200 mrem. Later, in a separate study (1990), the General Accounting Office postulated a worst-case accident of one to two orders of magnitude greater than that postulated in the DOE EIS. The uncertainties regarding the safety envelope of the Hanford Site ferrocyanide waste tanks led to the declaration of the Ferrocyanide Unreviewed Safety Question (USQ) in October 1990.

  3. Lung Function Measurements in Rodents in Safety Pharmacology Studies

    PubMed Central

    Hoymann, Heinz Gerd

    2012-01-01

    The ICH guideline S7A requires safety pharmacology tests including measurements of pulmonary function. In the first step – as part of the “core battery” – lung function tests in conscious animals are requested. If potential adverse effects raise concern for human safety, these should be explored in a second step as a “follow-up study”. For these two stages of safety pharmacology testing, both non-invasive and invasive techniques are needed which should be as precise and reliable as possible. A short overview of typical in vivo measurement techniques is given, their advantages and disadvantages are discussed and out of these the non-invasive head-out body plethysmography and the invasive but repeatable body plethysmography in orotracheally intubated rodents are presented in detail. For validation purposes the changes in the respective parameters such as tidal midexpiratory flow (EF50) or lung resistance have been recorded in the same animals in typical bronchoconstriction models and compared. In addition, the technique of head-out body plethysmography has been shown to be useful to measure lung function in juvenile rats starting from day two of age. This allows safety pharmacology testing and toxicological studies in juvenile animals as a model for the young developing organism as requested by the regulatory authorities (e.g., EMEA Guideline 1/2008). It is concluded that both invasive and non-invasive pulmonary function tests are capable of detecting effects and alterations on the respiratory system with different selectivity and area of operation. The use of both techniques in a large number of studies in mice and rats in the last years have demonstrated that they provide useful and reliable information on pulmonary mechanics in safety pharmacology and toxicology testing, in investigations of respiratory disorders, and in pharmacological efficacy studies. PMID:22973226

  4. The NOAA Satellite Observing System Architecture Study

    NASA Technical Reports Server (NTRS)

    Volz, Stephen; Maier, Mark; Di Pietro, David

    2016-01-01

    NOAA is beginning a study, the NOAA Satellite Observing System Architecture (NSOSA) study, to plan for the future operational environmental satellite system that will follow GOES and JPSS, beginning about 2030. This is an opportunity to design a modern architecture with no pre-conceived notions regarding instruments, platforms, orbits, etc. The NSOSA study will develop and evaluate architecture alternatives to include partner and commercial alternatives that are likely to become available. The objectives will include both functional needs and strategic characteristics (e.g., flexibility, responsiveness, sustainability). Part of this study is the Space Platform Requirements Working Group (SPRWG), which is being commissioned by NESDIS. The SPRWG is charged to assess new or existing user needs and to provide relative priorities for observational needs in the context of the future architecture. SPRWG results will serve as input to the process for new foundational (Level 0 and Level 1) requirements for the next generation of NOAA satellites that follow the GOES-R, JPSS, DSCOVR, Jason-3, and COSMIC-2 missions.

  5. Advanced Earth Observation System Instrumentation Study (aeosis)

    NASA Technical Reports Server (NTRS)

    White, R.; Grant, F.; Malchow, H.; Walker, B.

    1975-01-01

    Various types of measurements were studied for estimating the orbit and/or attitude of an Earth Observation Satellite. An investigation was made into the use of known ground targets in the earth sensor imagery, in combination with onboard star sightings and/or range and range rate measurements by ground tracking stations or tracking satellites (TDRSS), to estimate satellite attitude, orbital ephemeris, and gyro bias drift. Generalized measurement equations were derived for star measurements with a particular type of star tracker, and for landmark measurements with a multispectral scanner being proposed for an advanced Earth Observation Satellite. The use of infra-red horizon measurements to estimate the attitude and gyro bias drift of a geosynchronous satellite was explored.

  6. Globally Gridded Satellite observations for climate studies

    USGS Publications Warehouse

    Knapp, K.R.; Ansari, S.; Bain, C.L.; Bourassa, M.A.; Dickinson, M.J.; Funk, C.; Helms, C.N.; Hennon, C.C.; Holmes, C.D.; Huffman, G.J.; Kossin, J.P.; Lee, H.-T.; Loew, A.; Magnusdottir, G.

    2011-01-01

    Geostationary satellites have provided routine, high temporal resolution Earth observations since the 1970s. Despite the long period of record, use of these data in climate studies has been limited for numerous reasons, among them that no central archive of geostationary data for all international satellites exists, full temporal and spatial resolution data are voluminous, and diverse calibration and navigation formats encumber the uniform processing needed for multisatellite climate studies. The International Satellite Cloud Climatology Project (ISCCP) set the stage for overcoming these issues by archiving a subset of the full-resolution geostationary data at ~10-km resolution at 3-hourly intervals since 1983. Recent efforts at NOAA's National Climatic Data Center to provide convenient access to these data include remapping the data to a standard map projection, recalibrating the data to optimize temporal homogeneity, extending the record of observations back to 1980, and reformatting the data for broad public distribution. The Gridded Satellite (GridSat) dataset includes observations from the visible, infrared window, and infrared water vapor channels. Data are stored in Network Common Data Format (netCDF) using standards that permit a wide variety of tools and libraries to process the data quickly and easily. A novel data layering approach, together with appropriate satellite and file metadata, allows users to access GridSat data at varying levels of complexity based on their needs. The result is a climate data record already in use by the meteorological community. Examples include reanalysis of tropical cyclones, studies of global precipitation, and detection and tracking of the intertropical convergence zone.

  7. Summary of HEDL Fusion Reactor Safety Support studies

    SciTech Connect

    Muhlestein, L.D.; Jeppson, D.W.; Barreca, J.R.

    1981-01-01

    The HEDL Fusion Reactor Safety Support studies are focused on characterizing blanket-coolant-material reactions for deuterium-tritium fusion reactor designs. The objective is to determine and examine potential safety and environmental issues associated with proposed blanket/coolant combinations under postulated accident conditions. The first studies considered liquid lithium as both blanket and coolant, and examined liquid lithium-material reactions. Liquid lithium reactions with oxygen, nitrogen, and various concretes have been characterized. Evaluations of lithium reaction extinguishment methods, lithium aerosol generation and collection, and the volatilization and transport of radioactive materials in connection with lithium-air reactions have been completed. Lithium compound blanket material reactions with water, a prime coolant candidate, have been characterized in terms of energy and gas release rates. Blanket materials considered were lithium aluminate, lithium oxide, lithium zirconate, lithium silicate, and lithium lead alloys (Li/sub 7/Pb/sub 2/ and Li/sub 17/Pb/sub 83/).

  8. Study on the fiber grating sensors in concrete safety monitoring

    NASA Astrophysics Data System (ADS)

    Liu, Hang; Li, Yang; Zhang, Yu-hong

    2014-09-01

    The concrete may be damaged because there are freeze-thaw cycles between winter and summer in cold regions. Strain is an alternative parameter which can be used to describe deformation. In this paper, the fiber bragg gratings(FBG) were used to concrete safety monitoring. The strain and temperature sensing properties have been studied. The fiber reinforced polymers (FRP) were used for the packaged techniques of FBG sensors. The neural network was applied to temperature compensation for FBG sensors.

  9. 77 FR 19414 - Pipeline Safety: Public Comment on Leak and Valve Studies Mandated by the Pipeline Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-30

    ... Studies Mandated by the Pipeline Safety, Regulatory Certainty, and Job Creation Act of 2011 AGENCY..., Regulatory Certainty, and Job Creation Act of 2011 has called for several commissioned studies and reports...

  10. Overview of the Ocean Observer Satellite Study

    NASA Astrophysics Data System (ADS)

    Cunningham, J. D.; McGuire, J. P.; Pichel, W. G.; Gerber, A. J.

    2002-12-01

    A two-year study of ocean satellite remote sensing requirements and instrument/satellite options is nearing completion. This Ocean Observer Study was sponsored by the U.S. Dept. of Commerce/Dept. of Defense/National Aeronautics and Space Administration Integrated Program Office, whose mission is to develop the future U.S. National Polar-Orbiting Operational Environmental Satellite System (NPOESS). A comprehensive Ocean Observer User Requirements Document has been drafted by a team of over 150 government, academic, and private sector scientists, engineers, and administrators. Included are requirements for open and coastal ocean surface, cryospheric, hydrologic, and some land/hazard and atmospheric boundary layer parameters. This document was then used as input to the instrument and satellite study (conducted by the Jet Propulsion Laboratory) which produced five different instrument/satellite configuration options designed to address the maximum number of requirements which will not be met with the already-approved NPOESS instruments. Instruments studied include a synthetic aperture radar (SAR), an altimeter, and a hyper-spectral coastal infrared/visible imager. After analyzing the alternatives, it appears that one of the best options is a two-satellite system consisting of (1) an altimeter mission in the Topex/Poseidon orbit carrying both wide-swath and delayed doppler altimeters, and (2) a multi-polarization, multi-frequency, multi-mode interferometric SAR mission including a coastal imager in a polar sun-synchronous orbit. This paper summarizes the user requirements process, briefly describes the notional satellite configuration, and presents some of the capabilities of the instruments.

  11. Structural observation of long-span suspension bridges for safety assessment: implementation of an optical displacement measurement system

    NASA Astrophysics Data System (ADS)

    Lages Martins, L.; Rebordão, J. M.; Silva Ribeiro, A.

    2015-02-01

    This paper addresses the implementation of an optical displacement measurement system in the observation scenario of a long-span suspension bridge and its contribution for structural safety assessment. The metrological background required for quality assurance of the measurements is described, namely, the system's intrinsic parameterization and integration in the SI dimensional traceability chain by calibration, including its measurement uncertainty assessment.

  12. Preliminary Observations of an Equity 2000 Program "Safety Net" through the Lens of the Talent Development Framework.

    ERIC Educational Resources Information Center

    Wallace, Michael B.; Thompson, Sheila D.; Hughes, Gerunda B.

    As a preliminary step within a comprehensive evaluation plan, direct observation of a "safety-net" academic enrichment component of the College Board's Equity 2000 Program, in the form of the Saturday Academy, was conducted by researchers from the Center for Research on the Education of Students Placed at Risk/Howard University (RESPAR/HU)…

  13. Case study: the Argentina Road Safety Project: lessons learned for the decade of action for road safety, 2011-2020.

    PubMed

    Raffo, Veronica; Bliss, Tony; Shotten, Marc; Sleet, David; Blanchard, Claire

    2013-12-01

    This case study of the Argentina Road Safety Project demonstrates how the application of World Bank road safety project guidelines focused on institution building can accelerate knowledge transfer, scale up investment and improve the focus on results. The case study highlights road safety as a development priority and outlines World Bank initiatives addressing the implementation of the World Report on Road Traffic Injury's recommendations and the subsequent launch of the Decade of Action for Road Safety, from 2011-2020. The case study emphasizes the vital role played by the lead agency in ensuring sustainable road safety improvements and promoting the shift to a 'Safe System' approach, which necessitated the strengthening of all elements of the road safety management system. It summarizes road safety performance and institutional initiatives in Argentina leading up to the preparation and implementation of the project. We describe the project's development objectives, financing arrangements, specific components and investment staging. Finally, we discuss its innovative features and lessons learned, and present a set of supplementary guidelines, both to assist multilateral development banks and their clients with future road safety initiatives, and to encourage better linkages between the health and transportation sectors supporting them. PMID:24722740

  14. A Study in Iowa. Teaching Food Safety in Secondary FCS Classes

    ERIC Educational Resources Information Center

    Ellis, Jason D.; Henroid, Daniel H., Jr.

    2005-01-01

    Food safety is a significant issue in the United States and yet minimal research has been done on the inclusion of food safety in secondary school curricula. This study examined the feasibility of including food safety in Iowa FCS middle and secondary classes. Teachers reported food safety was important; only a few believed students were…

  15. Premarket Safety and Efficacy Studies for ADHD Medications in Children

    PubMed Central

    Bourgeois, Florence T.; Kim, Jeong Min; Mandl, Kenneth D.

    2014-01-01

    Background Attention-deficit hyperactivity disorder (ADHD) is a chronic condition and pharmacotherapy is the mainstay of treatment, with a variety of ADHD medications available to patients. However, it is unclear to what extent the long-term safety and efficacy of ADHD drugs have been evaluated prior to their market authorization. We aimed to quantify the number of participants studied and their length of exposure in ADHD drug trials prior to marketing. Methods We identified all ADHD medications approved by the Food and Drug Administration (FDA) and extracted data on clinical trials performed by the sponsor and used by the FDA to evaluate the drug’s clinical efficacy and safety. For each ADHD medication, we measured the total number of participants studied and the length of participant exposure and identified any FDA requests for post-marketing trials. Results A total of 32 clinical trials were conducted for the approval of 20 ADHD drugs. The median number of participants studied per drug was 75 (IQR 0, 419). Eleven drugs (55%) were approved after <100 participants were studied and 14 (70%) after <300 participants. The median trial length prior to approval was 4 weeks (IQR 2, 9), with 5 (38%) drugs approved after participants were studied <4 weeks and 10 (77%) after <6 months. Six drugs were approved with requests for specific additional post-marketing trials, of which 2 were performed. Conclusions Clinical trials conducted for the approval of many ADHD drugs have not been designed to assess rare adverse events or long-term safety and efficacy. While post-marketing studies can fill in some of the gaps, better assurance is needed that the proper trials are conducted either before or after a new medication is approved. PMID:25007171

  16. Space Station crew safety alternatives study. Volume 5: Space Station safety plan

    NASA Technical Reports Server (NTRS)

    Mead, G. H.; Peercy, R. L., Jr.; Raasch, R. F.

    1985-01-01

    The Space Station Safety Plan has been prepared as an adjunct to the subject contract final report, suggesting the tasks and implementation procedures to ensure that threats are addressed and resolution strategy options identified and incorporated into the space station program. The safety program's approach is to realize minimum risk exposure without levying undue design and operational constraints. Safety objectives and risk acceptances are discussed.

  17. Fusion-reactor blanket-material safety-compatibility studies

    SciTech Connect

    Jeppson, D.W.; Muhlestein, L.D.; Keough, R.F.; Cohen, S.

    1982-11-01

    Blanket material selection for fusion reactors is strongly influenced by the desire to minimize safety and environmental concerns. Blanket material safety compatibility studies are being conducted to identify and characterize blanket-coolant-material interactions under postulated reactor accident conditions. Recently completed scoping compatibility tests indicate that : (1) ternary oxides (LiAlO/sub 2/, Li/sub 2/ZrO/sub 3/, Li/sub 2/SiO/sub 3/, Li/sub 4/SiO/sub 4/ and LiTiO/sub 3/) at postulated blanket operating temperatures are compatible with water coolant, while liquid lithium and Li/sub 7/Pb/sub 2/ alloy reactions with water generate heat, aerosol and hydrogen; (2) lithium oxide and Li/sub 17/Pb/sub 83/ alloy react mildly with water requiring special precautions to control hydrogen release; (3) liquid lithium reacts substantially, while Li/sub 17/Pb/sub 83/ alloy reacts mildly with concrete to produce hydrogen; and (4) liquid lithium-air reactions present some major safety concerns.

  18. Clinical outcomes of low-dose leflunomide for rheumatoid arthritis complicated with Hepatitis B virus carriage and safety observation

    PubMed Central

    Ming-Xu, Hua; Chen, Meng; Cai, Yun; Yan-Jia, Hui

    2015-01-01

    Objective: To study the clinical outcomes of low-dose leflunomide for rheumatoid arthritis (RA) complicated with hepatitis B virus (HBV) carriage and to observe the safety. Methods: A total of 115 RA patients were divided into three groups according to the state of HBV. They were all given leflunomide to observe the clinical outcomes and whether HBV was activated. Results: The indices (e.g. activity score) of all patients were significantly better after treatment than those before (P < 0.05), with 89.00% (92/115) of them reaching ACR20. Fourteen cases (12.2%) suffered from abnormal liver functions, and 5 cases who had HBV reactivation originated from the HBV carriage group. Neither the previous HBV infection group nor the infection-free group succumbed to HBV reactivation. The multiple regression model showed that the HBV reactivation risk of RA patients treated by leflunomide was increased by 30% by the basic state of hepatitis B as well as alanine transaminase level and swollen joint count before treatment. Conclusion: Leflunomide exerted satisfactory therapeutic effects on RA, but liver diseases, liver function, HBV-DNA load and the reactivation risks of carried HBV should be thoroughly checked and cautiously pondered. PMID:26101483

  19. Experience from the Argentine Pegvisomant Observational Study: preliminary data.

    PubMed

    García Basavilbaso, N; Guitelman, M; Nagelberg, A; Stalldecker, G; Carabelli, A; Bruno, O; Danilowitz, K; Manavela, M; Mallea Gil, S; Ballarino, C; Guelman, R; Katz, D; Fidalgo, S; Leal, R; Fideleff, H; Servidio, M; Bruera, D; Librandi, F; Chervin, A; Vitale, M; Basso, A

    2010-01-01

    The GH receptor antagonist pegvisomant is an efficient agent to achieve biochemical control of acromegaly in those cases refractory to surgery and medical therapy with somatostatin analogs. We conducted an observational multicenter study consisting of data collection in accordance with the standard management of patients with acromegaly in everyday practice. We reviewed the medical records of 28 patients, 23 females, who were treated with pegvisomant due to the lack of biochemical response or intolerance to the somatostatin analogs. The objective was to monitor long-term safety and efficacy of the antagonist. 82% of the patients had previous pituitary surgery, 53.6% radiotherapy and 96.4% received medical therapy for acromegaly. Only 19.2% of the patients had pituitary residual tumor size larger than 1 cm, the remainder harbored a microadenoma or no visible tumor in the pituitary images. In terms of biochemical efficacy, IGF-I levels decreased to normal ranges in 45% and 58.8% of patients after 3 and 6 months of treatment, respectively, the daily mean dose of pegvisomant being 9.6+/-1.1 mg. Adverse events, potentially related to pegvisomant were reported in 6 patients (21.4%), local injection site reaction and elevated liver enzymes being the most frequent. Tumor size did not show enlargement in the evaluated population (15 patients) during the period of the study. This paper presents preliminary data from a small observational study in Argentina which represents the first database in our country. PMID:20616494

  20. Stories from the Sharp End: Case Studies in Safety Improvement

    PubMed Central

    McCarthy, Douglas; Blumenthal, David

    2006-01-01

    Motivated by pressure and a wish to improve, health care organizations are implementing programs to improve patient safety. This article describes six natural experiments in health care safety that show where the safety field is heading and opportunities for and barriers to improvement. All these programs identified organizational culture change as critical to making patients safer, differing chiefly in their methods of creating a patient safety culture. Their goal is a safety culture that promotes continuing innovation and improvement, transcending whatever particular safety methodology is used. Policymakers could help stimulate a culture of safety by linking regulatory goals to safety culture expectations, sponsoring voluntary learning collaborations, rewarding safety improvements, better using publicly reported data, encouraging consumer involvement, and supporting research and education. PMID:16529572

  1. An Analysis of Excavation Support Safety Based on Experimental Studies

    NASA Astrophysics Data System (ADS)

    Gorska, Karolina; Wyjadłowski, Marek

    2015-09-01

    The article presents the results of inclinometric measurements and numerical analyses of soldier-pile wall displacements. The excavation under investigation was made in cohesive soils. The measurements were conducted at points located at the edge of the cantilever excavation support system. The displacements of the excavation support observed over the period of three years demonstrated the pattern of steady growth over the first two months, followed by a gradual levelling out to a final plateau. The numerical analyses were conducted based on 3D FEM models. The numerical analysis of the problem comprise calculations of the global structural safety factor depending on the displacement of the chosen points in the lagging and conducted by means of the φ/c reduction procedure. The adopted graphical method of safety estimation is very conservative in the sense that it recognizes stability loss quite early, when one could further load the medium or weaken it by further strength reduction. The values of the Msf factor are relatively high. This is caused by the fact that the structure was designed for excavation twice as deep. Nevertheless, the structure is treated as a temporary one.

  2. A Medication Safety Model: A Case Study in Thai Hospital

    PubMed Central

    Rattanarojsakul, Phichai; Thawesaengskulthai, Natcha

    2013-01-01

    Reaching zero defects is vital in medication service. Medication error can be reduced if the causes are recognized. The purpose of this study is to search for a conceptual framework of the causes of medication error in Thailand and to examine relationship between these factors and its importance. The study was carried out upon an in-depth case study and survey of hospital personals who were involved in the drug use process. The structured survey was based on Emergency Care Research Institute (ECRI) (2008) questionnaires focusing on the important factors that affect the medication safety. Additional questionnaires included content to the context of Thailand's private hospital, validated by five-hospital qualified experts. By correlation Pearson analysis, the result revealed 14 important factors showing a linear relationship with drug administration error except the medication reconciliation. By independent sample t-test, the administration error in the hospital was significantly related to external impact. The multiple regression analysis of the detail of medication administration also indicated the patient identification before administration of medication, detection of the risk of medication adverse effects and assurance of medication administration at the right time, dosage and route were statistically significant at 0.05 level. The major implication of the study is to propose a medication safety model in a Thai private hospital. PMID:23985110

  3. Work-related injuries and occupational health and safety factors in smaller enterprises--a prospective study.

    PubMed

    Bull, N; Riise, T; Moen, B E

    2002-03-01

    The aim of this study was to determine whether any of the health, environmental and safety (HES) factors registered by visiting small mechanical enterprises in Norway at the start of the study could predict the risk of occupational injuries in subsequent years. Twelve HES factors, including injury awareness, programme for action, employee participation, training and use of personal safety devices, were registered. A questionnaire was completed by interviewing the employer and observing production. Two variables based on observation of the use of safety equipment were significantly correlated with occupational injuries. There is potential for prevention in smaller enterprises by increasing the use of personal protection devices and safety equipment on machines. Frequent inspection with feedback to the workers is probably the most effective means of attaining the desired result of reducing injuries. PMID:11967348

  4. Outcome studies and safety as guide for decision making in treating patients with type 2 diabetes.

    PubMed

    Cahn, Avivit; Cernea, Simona; Raz, Itamar

    2016-03-01

    Cardiovascular disease is the leading cause of mortality in patients with diabetes. Over the past 20 years multiple CV outcome studies have been conducted assessing the cardiovascular benefits of tight glycemic control or of particular glucose lowering agents. Improved glycemic control per-se failed to significantly reduce the risk of adverse cardiovascular outcomes in the short term, and it is only after >15 years that a reduction in adverse CV outcomes with tight glycemic control was perceived. Moreover tight glycemic control and increased attendant hypoglycemia led to increased mortality observed in the ACCORD trial. These data highlighted the importance of setting individualized glycemic targets and assessing the CV safety of the individual glucose lowering agents. Three DPP-4 inhibitors have presented CV outcome data to date demonstrating overall CV safety yet the question of increased hospitalization for heart failure with saxagliptin remains unexplained. Lixisenatide was the first GLP-1 receptor agonist to publish CV outcome data which demonstrated overall safety. The SGLT-2 inhibitor empagliflozin demonstrated CV superiority and a reduction in all-cause mortality and hospitalization for heart failure vs. placebo via mechanisms which remain to be fully elucidated. The outcome studies, though large and costly, have had a considerable effect on diabetes guidelines, these now emphasizing the importance of individualization of care. The outcome studies will presumably influence the new guidelines and dictate better tailoring of the drug regimen to the individual patient, matching patient comorbidities to the accumulating data regarding the safety and efficacy of each drug and class. PMID:27106831

  5. Space station crew safety alternatives study. Volume 3: Safety impact of human factors

    NASA Technical Reports Server (NTRS)

    Rockoff, L. A.; Raasch, R. F.; Peercy, R. L., Jr.

    1985-01-01

    The first 15 years of accumulated space station concepts for Initial Operational Capability (IOC) during the early 1990's was considered. Twenty-five threats to the space station are identified and selected threats addressed as impacting safety criteria, escape and rescue, and human factors safety concerns. Of the 25 threats identified, eight are discussed including strategy options for threat control: fire, biological or toxic contamination, injury/illness, explosion, loss of pressurization, radiation, meteoroid penetration and debris. Of particular interest here is volume three (of five volumes) pertaining to the safety impact of human factors.

  6. Tracking Study for Top-off Safety Validation at SSRL

    SciTech Connect

    Huang, X.; Bauer, J.; Corbett, J.; Dell'Orco, D.; Hettel, B.; Liu, J.; Rabedeau, T.; Safranek, J.; Schmerge, J.; Sebek, J.; Tanabe, J.; Terebilo, A.; Wang, L.

    2011-08-19

    A tracking study was performed at SSRL to identify necessary controls and to prove the safety of top-off operation from radiation hazard under such conditions. The safety rationale, tracking setup and the results are presented. Top-off operational mode has become a trend for existing and planned third-generation storage ring light sources for the many benefits such as increased average brightness, improved thermal stability and elimination of the interruption to user experiments due to traditional injection [1, 2]. Unlike the traditional decay mode injection which happens a few times a day and during which the photon beamline shutters are closed, top-off mode injection requires photon beamline shutters to remain open during injection and occurs much more frequently, from once every 5 seconds to once every 30 minutes. Therefore injection may be transparent to user experiments and the stored current variation can be significantly reduced. For a facility equipped with a full-energy injector, the biggest challenge to the implementation of the top-off mode may be the control of radiation hazard. Studies at ALS and SSRL [2, 3] have shown that a single injected electron pulse that enters the photon beamline and exits the radiation shield wall would cause unacceptable radiation doses on the experimental floor. For the protection of users and experimental equipment, it is hence a prerequisite for top-off operation to establish controls that absolutely prevent such occurrences. Similar to other facilities such as ALS and APS [2, 4], tracking simulations were conducted at SSRL to identify the control measures, define the specifications and prove the radiation safety. However, a different approach toward the proof of safety is taken at SSRL. In this paper we first describe the SSRL accelerator complex with emphasis on the aspects related to top-off in section 2. The general considerations and requirements for top-off are presented in section 3. Section 4 and 5 give a detailed

  7. Century Scale Evaporation Trend: An Observational Study

    NASA Technical Reports Server (NTRS)

    Bounoui, Lahouari

    2012-01-01

    Several climate models with different complexity indicate that under increased CO2 forcing, runoff would increase faster than precipitation overland. However, observations over large U.S watersheds indicate otherwise. This inconsistency between models and observations suggests that there may be important feedbacks between climate and land surface unaccounted for in the present generation of models. We have analyzed century-scale observed annual runoff and precipitation time-series over several United States Geological Survey hydrological units covering large forested regions of the Eastern United States not affected by irrigation. Both time-series exhibit a positive long-term trend; however, in contrast to model results, these historic data records show that the rate of precipitation increases at roughly double the rate of runoff increase. We considered several hydrological processes to close the water budget and found that none of these processes acting alone could account for the total water excess generated by the observed difference between precipitation and runoff. We conclude that evaporation has increased over the period of observations and show that the increasing trend in precipitation minus runoff is correlated to observed increase in vegetation density based on the longest available global satellite record. The increase in vegetation density has important implications for climate; it slows but does not alleviate the projected warming associated with greenhouse gases emission.

  8. Enhancing Patient Safety Using Clinical Nursing Data: A Pilot Study.

    PubMed

    Choi, Jeeyae; Choi, Jeungok E

    2016-01-01

    To enhance patient safety from falls, many hospital information systems have been implemented to collect clinical data from the bedside and have used the information to improve fall prevention care. However, most of them use administrative data not clinical nursing data. This necessitated the development of a web-based Nursing Practice and Research Information Management System (NPRIMS) that processes clinical nursing data to measure nurses' delivery of fall prevention care and its impact on patient outcomes. This pilot study developed computer algorithms based on a falls prevention protocol and programmed the prototype NPRIMS. It successfully measured the performance of nursing care delivered and its impact on patient outcomes using clinical nursing data from the study site. Results of the study revealed that NPRIMS has the potential to pinpoint components of nursing processes that are in need of improvement for preventing patient from falls. PMID:27332171

  9. RAMONA-4B development for SBWR safety studies

    SciTech Connect

    Rohatgi, U.S.; Aronson, A.L.; Cheng, H.S.; Khan, H.J.; Mallen, A.N.

    1993-12-31

    The Simplified Boiling Water Reactor (SBWR) is a revolutionary design of a boiling-water reactor. The reactor is based on passive safety systems such as natural circulation, gravity flow, pressurized gas, and condensation. SBWR has no active systems, and the flow in the vessel is by natural circulation. There is a large chimney section above the core to provide a buoyancy head for natural circulation. The reactor can be shut down by either of four systems; namely, scram, Fine Motion Control Rod Drive (FMCRD), Alternate Rod Insertion (ARI), and Standby Liquid Control System (SLCS). The safety injection is by gravity drain from the Gravity Driven Cooling System (GDCS) and Suppression Pool (SP). The heat sink is through two types of heat exchangers submerged in the tank of water. These heat exchangers are the Isolation Condenser (IC) and the Passive Containment Cooling System (PCCS). The RAMONA-4B code has been developed to simulate the normal operation, reactivity transients, and to address the instability issues for SBWR. The code has a three-dimensional neutron kinetics coupled to multiple parallel-channel thermal-hydraulics. The two-phase thermal hydraulics is based on a nonhomogeneous nonequilibrium drift-flux formulation. It employs an explicit integration to solve all state equations (except for neutron kinetics) in order to predict the instability without numerical damping. The objective of this project is to develop a Sun SPARC and IBM RISC 6000 based RAMONA-4B code for applications to SBWR safety analyses, in particular for stability and ATWS studies.

  10. Safety studies on Li/SOCl-2 reserve battery

    NASA Astrophysics Data System (ADS)

    Doddapaneni, N.

    1983-05-01

    The effects of cell design and metal-phthalocyanine catalysts on the safety of Li/SOCl2 reserve cells were evaluated. Cathode-limited design cells either vented or exploded during forced overdischarge. Both forced overdischarge current density, and overdischarge time into reversal influenced the cell failure unpredictably. Anode-limited design cells, on the other hand, generated severe internal heat during reversal, but sustained higher forced overdischarge current densities than cathode-limited design cells without either venting or exploding. When the 1.5M LiAlCl4/SOCl2 was replaced with 1.5M LiAlCl4/SO2Cl2 electrolyte in the cathode-limited design cells, both the cell discharge life and cell safety improved. The catalyst stability and stainless steel (bellow material) compatibility were also studied in both neutral and acidic electrolytes. The catalyst was found to be stable and the stainless steel specimens (316L and 321) experienced only surface corrosion after 12-month storage. The surface film formed during the initial surface corrosion appeared to inhibit further corrosion. Heat cool cycles between -40 and 71 C of fresh cells and partially or fully discharged D-cells did not adversely influence the cell pressure at the end of 100% depth of discharge.

  11. Fusion Material Studies Relating to Safety in Russia in 2002

    NASA Astrophysics Data System (ADS)

    Kolbasov, B. N.; Guseva, M. I.; Khripunov, B. I.; Martynenko, Y. V.; Romanov, P. V.; Lelekhov, S. A.; Bartenev, S. A.

    2004-10-01

    The paper is a summary of Russian material studies performed in frames of activities aiming at substantiation of safety of the International Thermonuclear Experimental Reactor (ITER) after 2001. Subthreshold sputtering of tungsten by 5 eV deuterons was revealed at temperatures above 1150°C. Mechanism of globular films formation was further studied. Computations of tritium permeation into vacuum vessel coolant confirmed the acceptability of vacuum vessel cooling system for removal of the decay heat. The most dangerous accident with high-current arc in toroidal superconducting magnets able to burn out a bore up to 0.6 m in diameter in the cryostat vessel was determined. Radiochemical reprocessing of V-Cr-Ti alloy and its purification from activation products down to a contact dose rate of ~10 μSv/h was developed.

  12. Public perception of drinking water safety in South Africa 2002–2009: a repeated cross-sectional study

    PubMed Central

    2012-01-01

    Background In low and middle income countries, public perceptions of drinking water safety are relevant to promotion of household water treatment and to household choices over drinking water sources. However, most studies of this topic have been cross-sectional and not considered temporal variation in drinking water safety perceptions. The objective of this study is to explore trends in perceived drinking water safety in South Africa and its association with disease outbreaks, water supply and household characteristics. Methods This repeated cross-sectional study draws on General Household Surveys from 2002–2009, a series of annual nationally representative surveys of South African households, which include a question about perceived drinking water safety. Trends in responses to this question were examined from 2002–2009 in relation to reported cholera cases. The relationship between perceived drinking water safety and organoleptic qualities of drinking water, supply characteristics, and socio-economic and demographic household characteristics was explored in 2002 and 2008 using hierarchical stepwise logistic regression. Results The results suggest that perceived drinking water safety has remained relatively stable over time in South Africa, once the expansion of improved supplies is controlled for. A large cholera outbreak in 2000–02 had no apparent effect on public perception of drinking water safety in 2002. Perceived drinking water safety is primarily related to water taste, odour, and clarity rather than socio-economic or demographic characteristics. Conclusion This suggests that household perceptions of drinking water safety in South Africa follow similar patterns to those observed in studies in developed countries. The stability over time in public perception of drinking water safety is particularly surprising, given the large cholera outbreak that took place at the start of this period. PMID:22834485

  13. Impact of the World Health Organization's Surgical Safety Checklist on safety culture in the operating theatre: a controlled intervention study

    PubMed Central

    Haugen, A. S.; Søfteland, E.; Eide, G. E.; Sevdalis, N.; Vincent, C. A.; Nortvedt, M. W.; Harthug, S.

    2013-01-01

    Background Positive changes in safety culture have been hypothesized to be one of the mechanisms behind the reduction in mortality and morbidity after the introduction of the World Health Organization's Surgical Safety Checklist (SSC). We aimed to study the checklist effects on safety culture perceptions in operating theatre personnel using a prospective controlled intervention design at a single Norwegian university hospital. Methods We conducted a study with pre- and post-intervention surveys using the intervention and control groups. The primary outcome was the effects of the Norwegian version of the SSC on safety culture perceptions. Safety culture was measured using the validated Norwegian version of the Hospital Survey on Patient Safety Culture. Descriptive characteristics of operating theatre personnel and checklist compliance data were also recorded. A mixed linear regression model was used to assess changes in safety culture. Results The response rate was 61% (349/575) at baseline and 51% (292/569) post-intervention. Checklist compliance ranged from 77% to 85%. We found significant positive changes in the checklist intervention group for the culture factors ‘frequency of events reported’ and ‘adequate staffing’ with regression coefficients at −0.25 [95% confidence interval (CI), −0.47 to −0.07] and 0.21 (95% CI, 0.07–0.35), respectively. Overall, the intervention group reported significantly more positive culture scores—including at baseline. Conclusions Implementation of the SSC had rather limited impact on the safety culture within this hospital. PMID:23404986

  14. Association between day of delivery and obstetric outcomes: observational study

    PubMed Central

    Bottle, A; Aylin, P

    2015-01-01

    Study question What is the association between day of delivery and measures of quality and safety of maternity services, particularly comparing weekend with weekday performance? Methods This observational study examined outcomes for maternal and neonatal records (1 332 835 deliveries and 1 349 599 births between 1 April 2010 and 31 March 2012) within the nationwide administrative dataset for English National Health Service hospitals by day of the week. Groups were defined by day of admission (for maternal indicators) or delivery (for neonatal indicators) rather than by day of complication. Logistic regression was used to adjust for case mix factors including gestational age, birth weight, and maternal age. Staffing factors were also investigated using multilevel models to evaluate the association between outcomes and level of consultant presence. The primary outcomes were perinatal mortality and—for both neonate and mother—infections, emergency readmissions, and injuries. Study answer and limitations Performance across four of the seven measures was significantly worse for women admitted, and babies born, at weekends. In particular, the perinatal mortality rate was 7.3 per 1000 babies delivered at weekends, 0.9 per 1000 higher than for weekdays (adjusted odds ratio 1.07, 95% confidence interval 1.02 to 1.13). No consistent association between outcomes and staffing was identified, although trusts that complied with recommended levels of consultant presence had a perineal tear rate of 3.0% compared with 3.3% for non-compliant services (adjusted odds ratio 1.21, 1.00 to 1.45). Limitations of the analysis include the method of categorising performance temporally, which was mitigated by using a midweek reference day (Tuesday). Further research is needed to investigate possible bias from unmeasured confounders and explore the nature of the causal relationship. What this study adds This study provides an evaluation of the “weekend effect” in obstetric care

  15. Phase I safety study of ranolazine in pulmonary arterial hypertension

    PubMed Central

    Schilz, Robert; Mediratta, Anuj; Addetia, Karima; Coslet, Sandra; Thomeas, Vasiliki; Gillies, Hunter; Oudiz, Ronald J.

    2015-01-01

    Abstract Pulmonary arterial hypertension (PAH) causes right ventricular ischemia, dysfunction, and failure. PAH patients may benefit from antianginal agents based on a shared pathophysiology with left ventricular ischemia. A single-center, randomized, placebo-controlled trial (1∶1) to assess the acute vasoreactivity and safety of ranolazine in PAH was conducted. Plasma samples for pharmacokinetic (PK) studies were drawn during hemodynamic measurements at 0, 60, 90, 120, 240, and 360 minutes from a Swan-Ganz catheter. All patients received 500-mg doses, uptitrated to 1,000 mg at week 4, monthly evaluations, and a complete objective assessment after 12 weeks, followed by an open-label extension. Thirteen patients were randomized and 12 enrolled (6 ranolazine, 6 placebo). All patients completed the acute phase; 10 completed the 12-week study. There were no acute changes in invasive hemodynamics. At 12 weeks ranolazine was well tolerated. Only 1 of the 5 patients on ranolazine had a serum concentration considered to be in the therapeutic range. Two serious adverse events required early withdrawal (both in the ranolazine group); gastrointestinal complaints were the most common adverse event. Efficacy measures did not demonstrate any differences between treatment groups. During the open-label trial, 2 additional patients reached a therapeutic concentration. Ranolazine in PAH appears safe, without acute hemodynamic effects after a 500-mg dose. Ranolazine administrated to PAH patients receiving background PAH therapies did not consistently reach therapeutic levels. Future studies should first perform PK analysis in PAH patients receiving PAH therapies and explore the safety and tolerability of the higher doses perhaps necessary to achieve therapeutic levels in PAH patients. (Trial registration: Clinicaltrials.gov identifier NCT01757808.) PMID:26697176

  16. Impact on Drug Safety of Variation in Adherence: The Need for Routinely Reporting Measures of Dose Intensity in Medication Safety Studies Using Electronic Health Data.

    PubMed

    Roughead, Elizabeth E; Pratt, Nicole L

    2015-12-01

    Randomized controlled trials always report the dose assessed and usually include a measure of adherence. By comparison, observational studies assessing medication safety often fail to report the dose used and rarely report any measure of adherence to therapy. This limits the ability to control for differences in doses used when undertaking meta-analyses. Non-adherence with therapy is common in the practice setting and varies across countries and settings. Inter-country differences in the registration of medicines may also result in different product strengths being available in different countries. These two factors combined means that observational studies undertaken for the same medicine in different settings may be assessing the same medicine but in circumstances where quite different dosages are used. Given that many adverse drug effects are dose dependent, differences in dosages used could be a factor explaining differences in risk estimates observed across studies. We argue that dose intensity, which can be defined as a product of the dose prescribed and adherence to the dose prescribed over the course of treatment, should be routinely reported in observational studies of medication safety. We illustrate the issue with the example of dabigatran. The randomized controlled trial evidence underpinning dabigatran's marketing authorization resulted in uncertainty about the appropriate dose for efficacy versus safety. As a result, different dosages of dabigatran were registered in the USA and Europe. The USA registered the 150- and 75-mg dabigatran products, while the 150- and 110-mg dabigatran products were registered in Europe. Among five observational studies subsequently undertaken to resolve the safety question concerning dabigatran and risk of bleeding, only one stratified results by dose. None of the US studies stratified results by the 75-mg dabigatran dose, despite this dose not being assessed in the original trial. None of the five studies reported

  17. Potential New Lidar Observations for Cloud Studies

    NASA Technical Reports Server (NTRS)

    Winker, Dave; Hu, Yong; Narir, Amin; Cai, Xia

    2015-01-01

    The response of clouds to global warming represents a major uncertainty in estimating climate sensitivity. These uncertainties have been tracked to shallow marine clouds in the tropics and subtropics. CALIOP observations have already been used extensively to evaluate model predictions of shallow cloud fraction and top height (Leahy et al. 2013; Nam et al 2012). Tools are needed to probe the lowest levels of the troposphere. The large footprint of satellite lidars gives large multiple scattering from clouds which presents new possibilities for cloud retrievals to constrain model predictions.

  18. Fire safety: A case study of technology transfer

    NASA Technical Reports Server (NTRS)

    Heins, C. F.

    1975-01-01

    Two basic ways in which NASA-generated technology is being used by the fire safety community are described. First, improved products and systems that embody NASA technical advances are entering the marketplace. Second, NASA test data and technical information related to fire safety are being used by persons concerned with reducing the hazards of fire through improved design information and standards. The development of commercial fire safety products and systems typically requires adaptation and integration of aerospace technologies that may not have been originated for NASA fire safety applications.

  19. Advanced Earth Observation System Instrumentation Study (AEOSIS)

    NASA Technical Reports Server (NTRS)

    Var, R. E.

    1976-01-01

    The feasibility, practicality, and cost are investigated for establishing a national system or grid of artificial landmarks suitable for automated (near real time) recognition in the multispectral scanner imagery data from an earth observation satellite (EOS). The intended use of such landmarks, for orbit determination and improved mapping accuracy is reviewed. The desirability of using xenon searchlight landmarks for this purpose is explored theoretically and by means of experimental results obtained with LANDSAT 1 and LANDSAT 2. These results are used, in conjunction with the demonstrated efficiency of an automated detection scheme, to determine the size and cost of a xenon searchlight that would be suitable for an EOS Searchlight Landmark Station (SLS), and to facilitate the development of a conceptual design for an automated and environmentally protected EOS SLS.

  20. Multispectral satellite observations for arid land studies

    NASA Technical Reports Server (NTRS)

    Choudhury, Bhaskar J.

    1992-01-01

    Multispectral satellite data when properly calibrated and standardized can be used synergistically for a quantitative analysis of processes and surface characteristics, and for quantifying land surface change. Relationships among multispectral satellite data (visible reflectance, surface temperature and polarization difference of microwave emission at 37 GHz frequency) have been used to develop hypotheses concerning the relative sensitivity of these data to varied land surface characteristics, which needs to be verified by field observations. Radiative transfer models have also been developed to understand these multispectral data. Interannual variations of visible reflectance and polarization difference for the period 1982-1986 over the Sahel and the Sudan zones of Africa show a lagged response with respect to the rainfall deficit during recovery from drought, which needs to be understood in terms of biophysical parameters.

  1. Experimental land observing data system feasibility study

    NASA Technical Reports Server (NTRS)

    Buckley, J. L.; Kraiman, H.

    1982-01-01

    An end-to-end data system to support a Shuttle-based Multispectral Linear Array (MLA) mission in the mid-1980's was defined. The experimental Land Observing System (ELOS) is discussed. A ground system that exploits extensive assets from the LANDSAT-D Program to effectively meet the objectives of the ELOS Mission was defined. The goal of 10 meter pixel precision, the variety of data acquisition capabilities, and the use of Shuttle are key to the mission requirements, Ground mission management functions are met through the use of GSFC's Multi-Satellite Operations Control Center (MSOCC). The MLA Image Generation Facility (MIGF) combines major hardware elements from the Applications Development Data System (ADDS) facility and LANDSAT Assessment System (LAS) with a special purpose MLA interface unit. LANDSAT-D image processing techniques, adapted to MLA characteristics, form the basis for the use of existing software and the definition of new software required.

  2. Aneurysm Study of Pipeline in an Observational Registry (ASPIRe)

    PubMed Central

    Kallmes, David F.; Brinjikji, Waleed; Boccardi, Edoardo; Ciceri, Elisa; Diaz, Orlando; Tawk, Rabih; Woo, Henry; Jabbour, Pascal; Albuquerque, Felipe; Chapot, Rene; Bonafe, Alain; Dashti, Shervin R.; Almandoz, Josser E. Delgado; Given, Curtis; Kelly, Michael E.; Cross, DeWitte T.; Duckwiler, Gary; Razack, Nasser; Powers, Ciaran J.; Fischer, Sebastian; Lopes, Demetrius; Harrigan, Mark R.; Huddle, Daniel; Turner, Raymond; Zaidat, Osama O.; Defreyne, Luc; Pereira, Vitor Mendes; Cekirge, Saruhan; Fiorella, David; Hanel, Ricardo A.; Lylyk, Pedro; McDougall, Cameron; Siddiqui, Adnan; Szikora, Istvan; Levy, Elad

    2016-01-01

    Background and Objective Few prospective studies exist evaluating the safety and efficacy of the Pipeline Embolization Device (PED) in the treatment of intracranial aneurysms. The Aneurysm Study of Pipeline In an observational Registry (ASPIRe) study prospectively analyzed rates of complete aneurysm occlusion and neurologic adverse events following PED treatment of intracranial aneurysms. Materials and Methods We performed a multicenter study prospectively evaluating patients with unruptured intracranial aneurysms treated with PED. Primary outcomes included (1) spontaneous rupture of the Pipeline-treated aneurysm; (2) spontaneous nonaneurysmal intracranial hemorrhage (ICH); (3) acute ischemic stroke; (4) parent artery stenosis, and (5) permanent cranial neuropathy. Secondary endpoints were (1) treatment success and (2) morbidity and mortality at the 6-month follow-up. Vascular imaging was evaluated at an independent core laboratory. Results One hundred and ninety-one patients with 207 treated aneurysms were included in this registry. The mean aneurysm size was 14.5 ± 6.9 mm, and the median imaging follow-up was 7.8 months. Twenty-four aneurysms (11.6%) were small, 162 (78.3%) were large and 21 (10.1%) were giant. The median clinical follow-up time was 6.2 months. The neurological morbidity rate was 6.8% (13/191), and the neurological mortality rate was 1.6% (3/191). The combined neurological morbidity/mortality rate was 6.8% (13/191). The most common adverse events were ischemic stroke (4.7%, 9/191) and spontaneous ICH (3.7%, 7/191). The complete occlusion rate at the last follow-up was 74.8% (77/103). Conclusions Our prospective postmarket study confirms that PED treatment of aneurysms in a heterogeneous patient population is safe with low rates of neurological morbidity and mortality. Patients with angiographic follow-up had complete occlusion rates of 75% at 8 months. PMID:27610126

  3. How Useful Are Home Safety Behaviours for Predicting Childhood Injury? A Cohort Study

    ERIC Educational Resources Information Center

    Kendrick, Denise; Watson, Michael; Mulvaney, Caroline; Burton, Paul

    2005-01-01

    Little work has examined the utility of home safety behaviours in predicting childhood injury. This study examines the relationship between safety behaviours and child injury using a cohort of 1717 families, with 2357 children aged 0-7 years. Safety behaviours, and sociodemographic and family characteristics were measured using a validated…

  4. Crashworthiness of Small Poststandard School Buses: Safety Study.

    ERIC Educational Resources Information Center

    National Transportation Safety Board (DOT), Washington, DC.

    In 1977, a series of Federal Motor Vehicle Safety Standards (FMVSS) for school buses became effective, mandating different performance standards for school buses compared to other buses. Because data on the crash performance of school buses built to these standards were lacking, the National Transportation Safety Board conducted a series of…

  5. What Is Popular Music Studies? Some Observations

    ERIC Educational Resources Information Center

    Cloonan, Martin

    2005-01-01

    Popular Music Studies (PMS) is now taught in over 20 higher education institutions (HEIs) in the UK and numerous others across the world. This article outlines the constituent parts of PMS in the UK and questions its status as a discipline in its own right. It concludes by arguing that, having established itself, PMS will need to deal with two key…

  6. Emergency department patient safety incident characterization: an observational analysis of the findings of a standardized peer review process

    PubMed Central

    2014-01-01

    Background Emergency Department (ED) care has been reported to be prone to patient safety incidents (PSIs). Improving our understanding of PSIs is essential to prevent them. A standardized, peer review process was implemented to identify and analyze ED PSIs. The primary objective of this investigation was to characterize ED PSIs identified by the peer review process. A secondary objective was to characterize PSIs that led to patient harm. In addition, we sought to provide a detailed description of the peer review process for others to consider as they conduct their own quality improvement initiatives. Methods An observational study was conducted in a large, urban, tertiary-care ED. Over a two-year period, all ED incident reports were investigated via a standardized, peer review process. PSIs were identified and analyzed for contributing factors including systems failures and practitioner-based errors. The classification system for factors contributing to PSIs was developed based on systems previously reported in the emergency medicine literature as well as the investigators’ experience in quality improvement and peer review. All cases in which a PSI was discovered were further adjudicated to determine if patient harm resulted. Results In 24 months, 469 cases were investigated, identifying 152 PSIs. In total, 188 systems failures and 96 practitioner-based errors were found to have contributed to the PSIs. In twelve cases, patient harm was determined to have resulted from PSIs. Systems failures were identified in eleven of the twelve cases in which a PSI resulted in patient harm. Conclusion Systems failures were almost twice as likely as practitioner-based errors to contribute to PSIs, and systems failures were present in the majority of cases resulting in patient harm. To effectively reduce PSIs, ED quality improvement initiatives should focus on systems failure reduction. PMID:25106803

  7. Preclinical Studies on the Pharmacokinetics, Safety and Toxicology of Oxfendazole: Toward First in Human Studies

    PubMed Central

    Codd, Ellen E.; Ng, Hanna H.; McFarlane, Claire; Riccio, Edward S.; Doppalapudi, Rupa; Mirsalis, Jon C.; Horton, R. John; Gonzalez, Armando E.; Garcia, H. Hugo; Gilman, Robert H.

    2015-01-01

    A two-week study in rats identified target organs of oxfendazole toxicity to be bone marrow, epididymis, liver, spleen, testis, and thymus. Female rats had greater oxfendazole exposure and exhibited toxicities at lower doses than did males. Decreased WBC levels, a class effect of benzimidazole anthelminthics, returned to normal during the recovery period. The NOAEL was determined to be >5 but < 25 mg/kg/d and the MTD 100 mg/kg/d. The highest dose, 200 mg/kg/d resulted in significant toxicity and mortality, leading to euthanization of the main study animals in this group after seven days. Oxfendazole did not exhibit genetic toxicology signals in standard Ames bacterial, mouse lymphoma or rat micronucleus assays, nor did it provoke safety concerns when evaluated for behavioral effects in rats or cardiovascular safety effects in dogs. These results support the transition of oxfendazole to First in Human safety studies preliminary to its evaluation in human helminth diseases. PMID:25701764

  8. Observational study of children with aerophagia.

    PubMed

    Loening-Baucke, Vera; Swidsinski, Alexander

    2008-09-01

    Aerophagia is a rare disorder in children. The diagnosis is often delayed, especially when it occurs concomitantly with constipation. The aim of this report is to increase awareness about aerophagia. This study describes 2 girls and 7 boys, 2 to 10.4 years of age, with functional constipation and gaseous abdominal distention. The abdomen was visibly distended, nontender, and tympanitic in all. Documenting less distention on awakening helped to make the diagnosis. Air swallowing, belching, and flatulence were infrequently reported. The rectal examination often revealed a dilated rectal ampulla filled with gas or stool and gas. The abdominal X-ray showed gaseous distention of the colon in all and of the stomach and small bowel in 8 children. Treatment consisted of educating parents and children about air sucking and swallowing, encouraging the children to stop the excessive air swallowing, and suggesting to them not to use drinking straws and not to drink carbonated beverages. The aerophagia resolved in all in 2 to 20 months (mean=8 months). PMID:18445758

  9. Air quality: from observation to applied studies

    NASA Astrophysics Data System (ADS)

    Weber, Christiane H.; Wania, Annett; Hirsch, Jacky; Bruse, Michael

    2004-10-01

    Air qualities studies in urban areas embrace several directions that are strongly associated with urban complexity. In the last centuries cities evolution implied changes in urbanization trends: urban sprawl has modified the relationship between cities and surroundings settlements. The existence and protection of urban green and open areas is promoted as a mean to improve the quality of life of their citizens and increase the satisfactory level of the inhabitants against pollution and noise adverse effects. This paper outlines the methods and approaches used in the EU research project Benefits of Urban Green Space (BUGS). The main target of BUGS is to assess the role of urban green spaces in alleviating the adverse effects of urbanization trends by developing an integrative methodology, ranging from participatory planning tools to numerical simulation models. The influence of urban structures on atmospheric pollutants distribution is investigated as a multi-scale problem ranging from micro to macro/regional scale. Traditionally, air quality models are applied on a single scale, seldom considering the joint effects of traffic network and urban development together. In BUGS, several numerical models are applied to cope with urban complexity and to provide quantitative and qualitative results. The differing input data requirements for the various models demanded a methodology which ensures a coherent data extraction and application procedure. In this paper, the stepwise procedure used for BUGS is presented after a general presentation of the research project and the models implied. A discussion part will highlight the statements induced by the choices made and a conclusive part bring to the stage some insights for future investigations.

  10. The Effects of Training, Feedback, and Participant Involvement in Behavioral Safety Observations on Office Ergonomic Behavior

    ERIC Educational Resources Information Center

    Sasson, Joseph R.; Austin, John

    2005-01-01

    Eleven computer terminal operators participated in an experiment that assessed effects of several interventions aimed at increasing safe ergonomic performance. All participants received ergonomics training and performance feedback while six of them collected observations of safe behavior among the remaining five participants. Effects of…

  11. Ferrocyanide safety project ferrocyanide aging studies FY 1995 annual report

    SciTech Connect

    Lilga, M.A.; Alderson, E.V.; Hallen, R.T.

    1995-09-01

    This annual report gives the results of the work conducted by the Pacific Northwest Laboratory in FY 1995 on Task 3 of the Ferrocyanide Safety Project, Ferrocyanide Aging Studies. Aging refers to the dissolution and hydrolysis of simulated Hanford ferrocyanide waste in alkaline aqueous solutions by radiolytic and chemical means. The ferrocyanide simulant primarily used in these studies was dried In-Farm-1B, Rev. 7, prepared by Westinghouse Hanford Company to simulate the waste generated when the In-Farm flowsheet was used to remove radiocesium from waste supernates in single-shell tanks at the Hanford Site. In the In-Farm flowsheet, nickel ion and ferrocyanide anion were added to waste supernates to precipitate sodium nickel ferrocyanide, Na{sub 2}NiFe(CN){sub 6}, and co-precipitate radiocesium. Once the radiocesium was removed, supernates were pumped from the tanks, and new wastes from cladding removal processes or from evaporators were added. These new wastes were typically highly caustic, having hydroxide ion concentrations of over 1 M and as high as 4 M. The Aging Studies task is investigating reactions this caustic waste may have had with the precipitated ferrocyanide waste in a radiation field. In previous Aging Studies research, Na{sub 2}NiFe(CN){sub 6} in simulants was shown to dissolve in basic solutions, forming insoluble Ni(OH){sub 2} and soluble Na{sub 4}Fe(CN){sub 6}. The influence on solubility of base strength, sodium ion concentration, anions, and temperature was previously investigated. The results may indicate that even ferrocyanide sludge that did not come into direct contact with highly basic wastes may also have aged significantly.

  12. Space Station crew safety alternatives study. Volume 2: Threat development

    NASA Technical Reports Server (NTRS)

    Raasch, R. F.; Peercy, R. L., Jr.; Rockoff, L. A.

    1985-01-01

    The first 15 years of accumulated space station concepts for initial operational capability (IOC) during the early 1990's were considered. Twenty-five threats to the space station are identified and selected threats addressed as impacting safety criteria, escape and rescue, and human factors safety concerns. Of the 25 threats identified, eight are discussed including strategy options for threat control: fire, biological or toxic contamination, injury/illness, explosion, loss of pressurization, radiation, meteoroid penetration, and debris.

  13. Space station crew safety alternatives study, volume 1

    NASA Technical Reports Server (NTRS)

    Peercy, R. L., Jr.; Raasch, R. F.; Rockoff, L. A.

    1985-01-01

    The first 15 years of accumulated space station concepts for initial operational capability (IOC) during the early 1990's were considered. Twenty-five threats to the space station are identified and selected threats addressed as impacting safety criteria, escape and rescue, and human factors safety concerns. Of the 25 threats identified, eight are discussed including strategy options for threat control: fire, biological or toxic contamination, injury/illness, explosion, loss of pressurization, radiation, meteoroid penetration and debris.

  14. Electronic Cigarettes Efficacy and Safety at 12 Months: Cohort Study

    PubMed Central

    Fiore, Maria; La Vecchia, Carlo; Marzuillo, Carolina; Gualano, Maria Rosaria; Liguori, Giorgio; Cicolini, Giancarlo; Capasso, Lorenzo; D'Amario, Claudio; Boccia, Stefania; Siliquini, Roberta; Ricciardi, Walter; Villari, Paolo

    2015-01-01

    Objective To evaluate the safety and efficacy as a tool of smoking cessation of electronic cigarettes (e-cigarettes), directly comparing users of e-cigarettes only, smokers of tobacco cigarettes only, and smokers of both. Design Prospective cohort study. Final results are expected in 2019, but given the urgency of data to support policies on electronic smoking, we report the results of the 12-month follow-up. Data Sources Direct contact and structured questionnaires by phone or via internet. Methods Adults (30–75 years) were included if they were smokers of ≥1 tobacco cigarette/day (tobacco smokers), users of any type of e-cigarettes, inhaling ≥50 puffs weekly (e-smokers), or smokers of both tobacco and e-cigarettes (dual smokers). Carbon monoxide levels were tested in a sample of those declaring tobacco smoking abstinence. Main Outcome Measures Sustained smoking abstinence from tobacco smoking at 12 months, reduction in the number of tobacco cigarettes smoked daily. Data Synthesis We used linear and logistic regression, with region as cluster unit. Results Follow-up data were available for 236 e-smokers, 491 tobacco smokers, and 232 dual smokers (overall response rate 70.8%). All e-smokers were tobacco ex-smokers. At 12 months, 61.9% of the e-smokers were still abstinent from tobacco smoking; 20.6% of the tobacco smokers and 22.0% of the dual smokers achieved tobacco abstinence. Adjusting for potential confounders, tobacco smoking abstinence or cessation remained significantly more likely among e-smokers (adjusted OR 5.19; 95% CI: 3.35–8.02), whereas adding e-cigarettes to tobacco smoking did not enhance the likelihood of quitting tobacco and did not reduce tobacco cigarette consumption. E-smokers showed a minimal but significantly higher increase in self-rated health than other smokers. Non significant differences were found in self-reported serious adverse events (eleven overall). Conclusions Adding e-cigarettes to tobacco smoking did not facilitate

  15. Development of electro-optical instrumentation for reactor safety studies

    SciTech Connect

    Turko, B.T.; Kolbe, W.F.; Leskovar, B.; Sun, R.K.

    1980-11-01

    The development of new electro-optical instrumentation for reactor safety studies is described. The system measures the thickness of the water film and droplet size and velocity distributions which would be encountered in the annular two-phase flow in a reactor cooling system. The water film thickness is measured by a specially designed capacitance system with a short time constant. Water droplet size and velocity are measured by a subsystem consisting of a continuously pulsed laser light source, a vidicon camera, a video recorder, and an automatic image analyzer. An endoscope system attached to the video camera is used to image the droplets. Each frame is strobed with two accurately spaced uv light pulses, from two sequentially fired nitrogen lasers. The images are stored in the video disk recorder. The modified automatic image analyzer is programmed to digitize the droplet size and velocity distributions. Many special optical, mechanical and electronic system components were designed and fabricated. They are described in detail, together with calibration charts and experimental results.

  16. A prospective study comparing the efficacy and safety of two sublingual birch allergen preparations

    PubMed Central

    2014-01-01

    Background SUBLIVAC FIX Birch (SUB-B) is a liquid oral preparation of Betula verrucosa pollen extract for the treatment of allergic rhinitis/rhinoconjuctivitis induced by birch pollen. The major allergen content of SUB-B and Staloral Birch (Stal-B) have been shown to be comparable. In order to compare the clinical efficacy and safety of both products, the present study was designed to investigate efficacy of treatment with SUB-B compared to Stal-B by means of reduction in allergy symptoms assessed by a titrated nasal provocation test (TNPT) in subjects suffering from IgE mediated allergy complaints triggered by birch pollen. Methods A prospective, randomized, open, blinded endpoint (PROBE), controlled, single-centre study in 74 birch allergic adults was performed. Treatment consisted of either SUB-B (10,000 AUN/ml) or Stal-B (initial phase 10 I.R./ml and maintenance phase 300 I.R./ml) for 16–20 weeks at maintenance dose. The primary efficacy outcome was defined by the difference in change of the TNPT-threshold dose between the two treatment groups at baseline and after completion of treatment. Secondary outcomes included determination of birch pollen specific IgE and IgG levels, safety lab and ECG. During the first 30 days of treatment, subjects were requested to fill out a diary concerning compliance with study medication, occurrence of AEs and the use of concomitant medication. Results Analysis of the primary efficacy parameter showed that the percentage of subjects showing a beneficial treatment effect was similar in both treatment groups, 33.3% for SUB-B vs. 31.4% for Stal-B in the intention to treat population. Evaluation of the immunologic response, showed that treatment with SUB-B and Stal-B induced similar increases (approximately 2 times) in IgE, IgG and IgG4 specific for Bet v 1. In total, 143 related adverse events (AEs) were reported. The majority of the AEs was of mild intensity. The same pattern of AEs was observed for both products. No clinically

  17. Receptionist input to quality and safety in repeat prescribing in UK general practice: ethnographic case study

    PubMed Central

    Greenhalgh, Trisha; Russell, Jill; Myall, Michelle

    2011-01-01

    Objective To describe, explore, and compare organisational routines for repeat prescribing in general practice to identify contributors and barriers to safety and quality. Design Ethnographic case study. Setting Four urban UK general practices with diverse organisational characteristics using electronic patient records that supported semi-automation of repeat prescribing. Participants 395 hours of ethnographic observation of staff (25 doctors, 16 nurses, 4 healthcare assistants, 6 managers, and 56 reception or administrative staff), and 28 documents and other artefacts relating to repeat prescribing locally and nationally. Main outcome measures Potential threats to patient safety and characteristics of good practice. Methods Observation of how doctors, receptionists, and other administrative staff contributed to, and collaborated on, the repeat prescribing routine. Analysis included mapping prescribing routines, building a rich description of organisational practices, and drawing these together through narrative synthesis. This was informed by a sociological model of how organisational routines shape and are shaped by information and communications technologies. Results Repeat prescribing was a complex, technology-supported social practice requiring collaboration between clinical and administrative staff, with important implications for patient safety. More than half of requests for repeat prescriptions were classed as “exceptions” by receptionists (most commonly because the drug, dose, or timing differed from what was on the electronic repeat list). They managed these exceptions by making situated judgments that enabled them (sometimes but not always) to bridge the gap between the idealised assumptions about tasks, roles, and interactions that were built into the electronic patient record and formal protocols, and the actual repeat prescribing routine as it played out in practice. This work was creative and demanded both explicit and tacit knowledge

  18. The perception of hospital safety culture and selected outcomes among nurses: An exploratory study.

    PubMed

    Saleh, Ali M; Darawad, Muhammad W; Al-Hussami, Mahmoud

    2015-09-01

    The objectives of this study were to examine nurses' perceptions of the hospital safety culture in Jordan and to identify the relationships between aspects of hospital safety culture and selected safety outcomes. Data from 242 registered nurses in five Jordanian hospitals were analyzed. Aspects of hospital safety culture and outcomes were measured using the Hospital Survey on Patient Safety Culture. Among various aspects of hospital safety culture, teamwork within units had the highest average percentage of positive responses (49.8%). Additionally, participants reported deficits in other aspects of safety culture, particularly in staffing and nonpunitive response to errors, with average percentages of positive responses of 30.4% and 30.7%, respectively. Pearson correlation analysis revealed that 9 of 10 subscales of hospital safety culture were significantly correlated to one or more of the hospital safety outcomes. The findings of this study can help policymakers and healthcare administrators identify the weaknesses and strengths of hospital safety issues in order to propose effective strategies to improve patient safety and quality of care. PMID:26095303

  19. Ventilatory function assessment in safety pharmacology: Optimization of rodent studies using normocapnic or hypercapnic conditions

    SciTech Connect

    Goineau, Sonia; Rompion, Sonia; Guillaume, Philippe; Picard, Sandra

    2010-09-15

    Although the whole body plethysmography for unrestrained animals is the most widely used method to assess the respiratory risk of new drugs in safety pharmacology, non-appropriate experimental conditions may mask deleterious side effects of some substances. If stimulant or bronchodilatory effects can be easily evidenced in rodents under standard experimental conditions, i.e. normal air breathing and diurnal phase, drug-induced respiratory depression remains more difficult to detect. This study was aimed at comparing the responsiveness of Wistar rats, Duncan Hartley guinea-pigs or BALB/c mice to the respiratory properties of theophylline (50 or 100 mg/kg p.o.) or morphine (30 mg/kg i.p.) under varying conditions (100% air versus 5% CO{sub 2}-enriched air, light versus dark day phase), in order to select the most appropriate experimental conditions to each species for safety airway investigations. Our results showed that under normocapnia the ventilatory depressant effects of morphine can be easily evidenced in mice, slightly observed in guinea-pigs and not detected in rats in any day phase. Slight hypercapnic conditions enhanced the responsiveness of rats to morphine but not that of guinea-pigs and importantly they did not blunt the airway responsiveness of rats to the stimulation and bronchodilation evoked by theophylline, the most widely used reference agent in safety pharmacology studies. In conclusion, hypercapnic conditions associated with the non-invasive whole body plethysmography should be considered for optimizing the assessment of both the ventilatory depressant potential of morphine-like substances or the respiratory stimulant effects of new drugs in the rat, the most extensively used species in rodent safety and toxicological investigations.

  20. Metabolism and toxicity studies supporting the safety of rebaudioside D.

    PubMed

    Nikiforov, Andrey I; Rihner, Marisa O; Eapen, Alex K; Thomas, Jennifer A

    2013-07-01

    Rebaudioside D (Reb D) is one of the several glycosides found in the leaves of Stevia rebaudiana (Bertoni) Bertoni (Compositae) which has been identified as a potential sweetener. The metabolism of Reb A and Reb D was evaluated in various in vitro matrices (simulated gastrointestinal fluids, rat liver microsomes, and rat cecal contents) and through analysis of plasma collected from rats in a dietary toxicity study. Reb A and Reb D showed similar stability when exposed to simulated stomach and small intestine fluids, with susceptibility to hydrolytic degradation by enteric bacteria collected from the cecum. Incubations with rat liver microsomes indicated that neither compound is expected to be metabolized by the liver enzymes. Plasma concentrations of Reb D, Reb A, and/or the final hydrolysis product of each compound, free/conjugated steviol, were consistent between animals administered either Reb D or Reb A in the diet. A repeated exposure dietary toxicity study was conducted to compare the safety of Reb D, when administered at target exposure levels of 500, 1000, and 2000 mg/kg body weight (bw)/d to Sprague-Dawley rats for 28 days, to that of Reb A administered at a target exposure level of 2000 mg/kg bw/d. There were no treatment-related effects on the general condition and behavior of the animals and no toxicologically relevant, treatment-related effects on hematology, serum chemistry, or urinalysis. Macroscopic and microscopic findings revealed no treatment-related effects on any organ evaluated. Results were comparable between the group administered 2000 mg/kg/d Reb D and the group administered 2000 mg/kg/d Reb A. PMID:23766392

  1. Cardiac Safety of Modified Vaccinia Ankara for Vaccination against Smallpox in a Young, Healthy Study Population

    PubMed Central

    Zitzmann-Roth, Eva-Maria; von Sonnenburg, Frank; de la Motte, Stephan; Arndtz-Wiedemann, Nathaly; von Krempelhuber, Alfred; Uebler, Nadine; Vollmar, Jens; Virgin, Garth; Chaplin, Paul

    2015-01-01

    Background Conventional smallpox vaccines based on replicating vaccinia virus (VV) strains (e.g. Lister Elstree, NYCBOH) are associated with a high incidence of myo-/pericarditis, a severe inflammatory cardiac complication. A new smallpox vaccine candidate based on a non-replicating Modified Vaccinia Ankara (MVA) poxvirus has been assessed for cardiac safety in a large placebo-controlled clinical trial. Methods Cardiac safety of one and two doses of MVA compared to placebo was assessed in 745 healthy subjects. Vaccinia-naïve subjects received either one dose of MVA and one dose of placebo, two doses of MVA, or two doses of placebo by subcutaneous injection four weeks apart; vaccinia-experienced subjects received a single dose of MVA. Solicited and unsolicited adverse events (AE) and cardiac safety parameters (recorded as Adverse Events of Special Interest, AESI) were monitored after each injection. Results A total of 5 possibly related AESI (3 cases of palpitations, 2 of tachycardia) were reported during the study. No case of myo- or pericarditis occurred. One possibly related serious AE (SAE) was reported during the 6-month follow-up period (sarcoidosis). The most frequently observed AEs were injection site reactions. Conclusions Vaccination with MVA was safe and well tolerated and did not increase the risk for development of myo-/pericarditis. Trial Registration ClinicalTrials.gov NCT00316524 PMID:25879867

  2. Safety and efficacy of aneurysm treatment with WEB: results of the WEBCAST study.

    PubMed

    Pierot, Laurent; Costalat, Vincent; Moret, Jacques; Szikora, Istvan; Klisch, Joachim; Herbreteau, Denis; Holtmannspötter, Markus; Weber, Werner; Januel, Anne-Christine; Liebig, Thomas; Sychra, Vojtech; Strasilla, Christoph; Cognard, Christophe; Bonafé, Alain; Molyneux, Andrew; Byrne, James V; Spelle, Laurent

    2016-05-01

    OBJECT WEB is an innovative intrasaccular treatment for intracranial aneurysms. Preliminary series have shown good safety and efficacy. The WEB Clinical Assessment of Intrasaccular Aneurysm Therapy (WEBCAST) trial is a prospective European trial evaluating the safety and efficacy of WEB in wide-neck bifurcation aneurysms. METHODS Patients with wide-neck bifurcation aneurysms for which WEB treatment was indicated were included in this multicentergood clinical practices study. Clinical data including adverse events and clinical status at 1 and 6 months were collected and independently analyzed by a medical monitor. Six-month follow-up digital subtraction angiography was also performed and independently analyzed by a core laboratory. Success was defined at 6 months as complete occlusion or stable neck remnant, no worsening in angiographic appearance from postprocedure, and no retreatment performed or planned. RESULTS Ten European neurointerventional centers enrolled 51 patients with 51 aneurysms. Treatment with WEB was achieved in 48 of 51 aneurysms (94.1%). Adjunctive implants (coils/stents) were used in 4 of 48 aneurysms (8.3%). Thromboembolic events were observed in 9 of 51 patients (17.6%), resulting in a permanent deficit (modified Rankin Scale [mRS] Score 1) in 1 patient (2.0%). Intraoperative rupture was not observed. Morbidity (mRS score > 2) and mortality were 2.0% (1 of 51 patients, related to rupture status on entry to study) and 0.0% at 1 month, respectively. Success was achieved at 6 months in 85.4% of patients treated with WEB: 23 of 41 patients (56.1%) had complete occlusion, 12 of 41 (29.3%) had a neck remnant, and 6 of 41 (14.6%) had an aneurysm remnant. CONCLUSIONS The WEBCAST study showed good procedural and short-term safety of aneurysm treatment with WEB and good 6-month anatomical results. PMID:26381253

  3. A Randomized Trial Comparing the Efficacy and Safety of Intravitreal Triamcinolone With Observation to Treat Vision Loss Associated With Macular Edema Secondary to Central Retinal Vein Occlusion

    PubMed Central

    Ip, Michael S.; Scott, Ingrid U.; VanVeldhuisen, Paul C.; Oden, Neal L.; Blodi, Barbara A.; Fisher, Marian; Singerman, Lawrence J.; Tolentino, Michael; Chan, Clement K.; Gonzalez, Victor H.

    2009-01-01

    Objective: To compare the efficacy and safety of 1-mg and 4-mg doses of preservative-free intravitreal triamcinolone with observation for eyes with vision loss associated with macular edema secondary to perfused central retinal vein occlusion (CRVO). Methods: Multicenter, randomized, clinical trial of 271 participants. Main Outcome Measure: Gain in visual acuity letter score of 15 or more from baseline to month 12. Results: Seven percent, 27%, and 26% of participants achieved the primary outcome in the observation, 1-mg, and 4-mg groups, respectively. The odds of achieving the primary outcome were 5.0 times greater in the 1-mg group than the observation group (odds ratio [OR],5.0; 95% confidence interval [CI], 1.8-14.1; P=.001) and 5.0 times greater in 4-mg group than the observation group (OR,5.0; 95% CI, 1.8-14.4; P=.001); there was no difference identified between the 1-mg and 4-mg groups (OR, 1.0; 95% CI, 0.5-2.1; P=.97). The rates of elevated intraocular pressure and cataract were similar for the observation and 1-mg groups, but higher in the 4-mg group. Conclusions: Intravitreal triamcinolone is superior to observation for treating vision loss associated with macular edema secondary to CRVO in patients who have characteristics similar to those in the SCORE-CRVO trial. The 1-mg dose has a safety profile superior to that of the 4-mg dose. Application to Clinical Practice: Intravitreal triamcinolone in a 1-mg dose, following the retreatment criteria applied in the SCORE Study, should be considered for up to 1 year, and possibly 2 years, for patients with characteristics similar to those in the SCORE-CRVO trial. Trial Registration: clinicaltrials.gov Identifier: NCT00105027 PMID:19752419

  4. Observations in Lidar Station of St. Petersburg State University for Ecological Safety Studyies

    NASA Astrophysics Data System (ADS)

    Donchenko, Vladislav; Melnikova, Irina; Samulenkov, Dmitriy; Sapunov, Maksim

    2016-06-01

    The solution of many problems associated with the air pollution, radiative regime of the earth's surface and atmosphere, global and local environmental changes and climate, facing humanity in the early 21st century, require detailed and regular information on atmospheric aerosol and gaseous pollutants in the atmosphere. For monitoring atmospheric pollutants especially effective were the methods of laser sounding of the atmosphere, which provide a vertical profile of aerosol parameters to a height of 20 km In this regard, at the beginning of the 21st century created a continental networks of lidar sounding stations. Over Europe there is a network EARLINET. Laser station, built on the basis of St. Petersburg State University has become the first Russian station that acceded to the European research network. The article briefly presents the technical features of the equipment and demonstrates the first results of the observations.

  5. NASA Satellite Observations: A Unique Asset for the Study of the Environment and Implications for Public Health

    NASA Technical Reports Server (NTRS)

    Estes Sue M.

    2010-01-01

    This slide presentation highlights how satellite observation systems are assets for studying the environment in relation to public health. It includes information on current and future satellite observation systems, NASA's public health and safety research, surveillance projects, and NASA's public health partners.

  6. Frequency of and predictors for withholding patient safety concerns among oncology staff: a survey study.

    PubMed

    Schwappach, D L B; Gehring, K

    2015-05-01

    Speaking up about patient safety is vital to avoid errors reaching the patient and to improve a culture of safety. This study investigated the prevalence of non-speaking up despite concerns for safety and aimed to identify predictors for withholding voice among healthcare professionals (HCPs) in oncology. A self-administered questionnaire assessed safety concerns, speaking up beliefs and behaviours among nurses and doctors from nine oncology departments. Multiple regression analysis was used to identify predictors for withholding safety concerns. A total of 1013 HCPs returned the completed survey (response rate 65%). Safety concerns were common among responders. Fifty-four per cent reported to recognise their colleagues making potentially harmful errors at least sometimes. A majority of responders reported at least some episodes of withholding concerns about patient safety. Thirty-seven per cent said they remained silent at least once when they had information that might have helped prevent an incident. Respondents believed that a high level of interpersonal, communication and coping skills are necessary to speak up about patient safety issues at their workplace. Higher levels of perceived advocacy for patient safety and psychological safety significantly decreased the frequency of withholding voice. Remaining silent about safety concerns is a common phenomenon in oncology. Improved strategies are needed to support staff in effective communication and make cancer care safer. PMID:25287114

  7. Automated Mixed Traffic Vehicle (AMTV) technology and safety study

    NASA Technical Reports Server (NTRS)

    Johnston, A. R.; Peng, T. K. C.; Vivian, H. C.; Wang, P. K.

    1978-01-01

    Technology and safety related to the implementation of an Automated Mixed Traffic Vehicle (AMTV) system are discussed. System concepts and technology status were reviewed and areas where further development is needed are identified. Failure and hazard modes were also analyzed and methods for prevention were suggested. The results presented are intended as a guide for further efforts in AMTV system design and technology development for both near term and long term applications. The AMTV systems discussed include a low speed system, and a hybrid system consisting of low speed sections and high speed sections operating in a semi-guideway. The safety analysis identified hazards that may arise in a properly functioning AMTV system, as well as hardware failure modes. Safety related failure modes were emphasized. A risk assessment was performed in order to create a priority order and significant hazards and failure modes were summarized. Corrective measures were proposed for each hazard.

  8. Study on Safety Technology Scheme of the Unmanned Helicopter

    NASA Astrophysics Data System (ADS)

    Lin, Z.; Zhang, W.; Chen, S.; Liu, T.; Yao, Y.

    2013-08-01

    Nowadays the unmanned helicopter is widely used for its' unique strongpoint, however, the high failure rate of unmanned helicopter seriously limits its further application and development. For solving the above problems, in this paper, the reasons for the high failure rate of unmanned helicopter is analyzed and the corresponding solution schemes are proposed. The main problem of the failure cause of the unmanned helicopter is the aircraft engine fault, and the failure cause of the unmanned helicopter is analyzed particularly. In order to improving the safety performance of unmanned helicopter system, the scheme of adding the safety parachute system to the unmanned helicopter system is proposed and introduced. These schemes provide the safety redundancy of the unmanned helicopter system and lay on basis for the unmanned helicopter applying into residential areas.

  9. Child/Adolescent Anxiety Multimodal Study: Evaluating Safety

    PubMed Central

    Rynn, Moira A.; Walkup, John T.; Compton, Scott N.; Sakolsky, Dara J.; Sherrill, Joel T.; Shen, Sa; Kendall, Philip C.; McCracken, James; Albano, Anne Marie; Piacentini, John; Riddle, Mark A.; Keeton, Courtney; Waslick, Bruce; Chrisman, Allan; Iyengar, Satish; March, John S.; Birmaher, Boris

    2015-01-01

    Objective To evaluate the frequency of adverse events (AEs) across four treatment conditions in the Child/Adolescent Anxiety Multimodal Study (CAMS), and to compare the frequency of AEs between children and adolescents. Method Participants ages 7-17 years (M=10.7) meeting the DSM-IV criteria for one or more of the following disorders: separation anxiety disorder, generalized anxiety disorder, or social phobia were randomized (2:2:2:1) to cognitive-behavioral therapy (CBT, n=139), sertraline (SRT, n=133), combination of both (COMB, n=140), or pill placebo (PBO, n=76). AEs were collected via a standardized inquiry method plus a self-report Physical Symptom Checklist (PSC). Results There were no differences between the double-blinded conditions (SRT vs. PBO) for total physical and psychiatric AEs or any individual physical or psychiatric AEs. The rates of total physical AEs were greater in the SRT-alone treatment condition when compared to CBT (p<.01) and COMB (p<.01). Moreover, those who received SRT alone reported higher rates of several physical AEs when compared to COMB and CBT. The rate of total psychiatric AEs was higher in children (≤12 years) across all arms (31.7% vs. 23.1%, p<.05). Total PSC scores decreased over time with no significant differences between treatment groups. Conclusion The results support the tolerability/safety of selective serotonin reuptake inhibitor (SSRI) treatment for anxiety disorders even after adjusting for the number of reporting opportunities leading to no differences in overall rates of AEs. Few differences occurred on specific items. Additional monitoring of psychiatric AEs is recommended in children (≤12 years). PMID:25721183

  10. Occupational Health and Safety Issues in Ontario Sawmills and Veneer/Plywood Plants: A Pilot Study

    PubMed Central

    Verma, Dave K.; Demers, Cecil; Shaw, Don; Verma, Paul; Kurtz, Lawrence; Finkelstein, Murray; des Tombe, Karen; Welton, Tom

    2010-01-01

    A pilot study was conducted within the Ontario sawmill and veneer/plywood manufacturing industry. Information was collected by postal questionnaire and observational walk-through surveys. Industrial hygiene walk-through surveys were conducted at 22 work sites, and measurements for wood dust, noise, and bioaerosol were taken. The aim of the study was to obtain data on the current status regarding health and safety characteristics and an estimate of wood dust, noise, and bioaerosol exposures. The occupational exposure to wood dust and noise are similar to what has been reported in this industry in Canada and elsewhere. Airborne wood dust concentration ranged between 0.001 mg/m3 and 4.87 mg/m3 as total dust and noise exposure ranged between 55 and 117 dB(A). The study indicates the need for a more comprehensive industry-wide study of wood dust, noise, and bioaersols. PMID:21253473

  11. Occupational health and safety issues in Ontario sawmills and veneer/plywood plants: a pilot study.

    PubMed

    Verma, Dave K; Demers, Cecil; Shaw, Don; Verma, Paul; Kurtz, Lawrence; Finkelstein, Murray; des Tombe, Karen; Welton, Tom

    2010-01-01

    A pilot study was conducted within the Ontario sawmill and veneer/plywood manufacturing industry. Information was collected by postal questionnaire and observational walk-through surveys. Industrial hygiene walk-through surveys were conducted at 22 work sites, and measurements for wood dust, noise, and bioaerosol were taken. The aim of the study was to obtain data on the current status regarding health and safety characteristics and an estimate of wood dust, noise, and bioaerosol exposures. The occupational exposure to wood dust and noise are similar to what has been reported in this industry in Canada and elsewhere. Airborne wood dust concentration ranged between 0.001 mg/m³ and 4.87 mg/m³ as total dust and noise exposure ranged between 55 and 117 dB(A). The study indicates the need for a more comprehensive industry-wide study of wood dust, noise, and bioaersols. PMID:21253473

  12. The Role of Hospital Inpatients in Supporting Medication Safety: A Qualitative Study

    PubMed Central

    Garfield, Sara; Jheeta, Seetal; Husson, Fran; Lloyd, Jill; Taylor, Alex; Boucher, Charles; Jacklin, Ann; Bischler, Anna; Norton, Christine; Hayles, Rob; Dean Franklin, Bryony

    2016-01-01

    Background Inpatient medication errors are a significant concern. An approach not yet widely studied is to facilitate greater involvement of inpatients with their medication. At the same time, electronic prescribing is becoming increasingly prevalent in the hospital setting. In this study we aimed to explore hospital inpatients’ involvement with medication safety-related behaviours, facilitators and barriers to this involvement, and the impact of electronic prescribing. Methods We conducted ethnographic observations and interviews in two UK hospital organisations, one with established electronic prescribing and one that changed from paper to electronic prescribing during our study. Researchers and lay volunteers observed nurses’ medication administration rounds, pharmacists’ ward rounds, doctor-led ward rounds and drug history taking. We also conducted interviews with healthcare professionals, patients and carers. Interviews were audio-recorded and transcribed. Observation notes and transcripts were coded thematically. Results Paper or electronic medication records were shown to patients in only 4 (2%) of 247 cases. However, where they were available during patient-healthcare professional interactions, healthcare professionals often viewed them in order to inform patients about their medicines and answer any questions. Interprofessional discussions about medicines seemed more likely to happen in front of the patient where paper or electronic drug charts were available near the bedside. Patients and carers had more access to paper-based drug charts than electronic equivalents. However, interviews and observations suggest there are potentially more significant factors that affect patient involvement with their inpatient medication. These include patient and healthcare professional beliefs concerning patient involvement, the way in which healthcare professionals operate as a team, and the underlying culture. Conclusion Patients appear to have more access to

  13. Challenges to and the future of medication safety in Saudi Arabia: A qualitative study

    PubMed Central

    Aljadhey, Hisham; Mahmoud, Mansour Adam; Hassali, Mohamed Azmi; Alrasheedy, Alian; Alahmad, Amjad; Saleem, Fahad; Sheikh, Aziz; Murray, Michael; Bates, David W.

    2013-01-01

    Background Medication safety is a global concern among healthcare providers. However, the challenges to and the future of medication safety in Saudi Arabia have not been explored. Objectives We explored the perspectives of healthcare practitioners on current issues about medication safety in hospitals and community settings in Saudi Arabia in order to identify challenges to improving it and explore the future of medication safety practice. Methods A total of 65 physicians, pharmacists, academics and nurses attended a one-day meeting in March 2010, designed especially for the purpose of this study. The participants were divided into nine round-table discussion sessions. Three major themes were explored in these sessions, including: major factors contributing to medication safety problems, challenges to improving medication safety practice, and participants’ suggestions for improving medication safety. The round-table discussion sessions were videotaped and transcribed verbatim and analyzed by two independent researchers. Results The round-table discussions revealed that major factors contributing to medication safety problems included unrestricted public access to medications from various hospitals and community pharmacies, communication gaps between healthcare institutions, limited use of important technologies such as computerized provider order entry, and the lack of medication safety programs in hospitals. Challenges to current medication safety practice identified by participants included underreporting of medication errors and adverse drug reactions, multilingualism and differing backgrounds of healthcare professionals, lack of communication between healthcare providers and patients, and high workloads. Suggestions for improving medication safety practices in Saudi Arabia included continuous education for healthcare professionals and competency assessment focusing on medication safety, development of a culture that encourages medication error and adverse

  14. Phenomenological studies on sodium for CSP applications: A safety review

    NASA Astrophysics Data System (ADS)

    Armijo, Kenneth M.; Andraka, Charles E.

    2016-05-01

    Sodium Heat transfer fluids (HTF) such as sodium, can achieve temperatures above 700°C to obtain power cycle performance improvements for reducing large infrastructure costs of high-temperature systems. Current concentrating solar power (CSP) sensible HTF's (e.g. air, salts) have poor thermal conductivity, and thus low heat transfer capabilities, requiring a large receiver. The high thermal conductivity of sodium has demonstrated high heat transfer rates on dish and towers systems, which allow a reduction in receiver area by a factor of two to four, reducing re-radiation and convection losses and cost by a similar factor. Sodium produces saturated vapor at pressures suitable for transport starting at 600°C and reaches one atmosphere at 870°C, providing a wide range of suitable operating conditions that match proposed high temperature, isothermal power cycles. This advantage could increase the efficiency while lowering the cost of CSP tower systems. Although there are a number of desirable thermal performance advantages associated with sensible sodium, its propensity to rapidly oxidize presents safety challenges. This investigation presents a literature review that captures historical operations/handling lessons for advanced sodium receiver designs, and the current state-of-knowledge related to sodium combustion behavior. Technical and operational solutions addressing sodium safety and applications in CSP will be discussed, including unique safety hazards and advantages using latent sodium. Lessons obtained from the nuclear industry with sensible and latent systems will also be discussed in the context of safety challenges and risk mitigation solutions.

  15. Ready to Respond: Case Studies in Campus Safety and Security

    ERIC Educational Resources Information Center

    Hyatt, James A.

    2010-01-01

    Is your campus primed for the next big emergency? The National Campus Safety and Security Project (NCSSP), led by NACUBO, sought to help colleges and universities develop comprehensive emergency management plans that address the four phases of emergency management: prevention/mitigation, preparedness, response, and recovery. A major component of…

  16. Safety in earth orbit study. Volume 1: Technical summary

    NASA Technical Reports Server (NTRS)

    1972-01-01

    A summary of the technical results and conclusions is presented of the hazards analyses of earth orbital operations in conjunction with the space shuttle program. The space shuttle orbiter and a variety of manned and unmanned payloads delivered to orbit by the shuttle are considered. The specific safety areas examined are hazardous payloads, docking, on-orbit survivability, tumbling spacecraft, and escape and rescue.

  17. Treatment for Adolescents with Depression Study (TADS): Safety Results

    ERIC Educational Resources Information Center

    Emslie, Graham; Kratochvil, Christopher; Vitiello, Benedetto; Silva, Susan; Mayes, Taryn; McNulty, Steven; Weller, Elizabeth; Waslick, Bruce; Casat, Charles; Walkup, John; Pathak, Sanjeev; Rohde, Paul; Posner, Kelly; March, John

    2006-01-01

    Objective: To compare the rates of physical, psychiatric, and suicide-related events in adolescents with MDD treated with fluoxetine alone (FLX), cognitive-behavioral therapy (CBT), combination treatment (COMB), or placebo (PBO). Method: Safety assessments included adverse events (AEs) collected by spontaneous report, as well as systematic…

  18. Study of a safety margin system for powered-lift STOL aircraft

    NASA Technical Reports Server (NTRS)

    Heffley, R. K.; Jewell, W. F.

    1978-01-01

    A study was conducted to explore the feasibility of a safety margin system for powered-lift aircraft which require a backside piloting technique. The objective of the safety margin system was to present multiple safety margin criteria as a single variable which could be tracked manually or automatically and which could be monitored for the purpose of deriving safety margin status. The study involved a pilot-in-the-loop analysis of several safety margin system concepts and a simulation experiment to evaluate those concepts which showed promise of providing a good solution. A system was ultimately configured which offered reasonable compromises in controllability, status information content, and the ability to regulate the safety margin at some expense of the allowable low speed flight path envelope.

  19. Promoting Health and Safety in San Francisco's Chinatown Restaurants: Findings and Lessons Learned from a Pilot Observational Checklist

    PubMed Central

    Gaydos, Megan; Bhatia, Rajiv; Morales, Alvaro; Lee, Pam Tau; Liu, Shaw San; Chang, Charlotte; Salvatore, Alicia L.; Krause, Niklas; Minkler, Meredith

    2011-01-01

    Noncompliance with labor and occupational health and safety laws contributes to economic and health inequities. Environmental health agencies are well positioned to monitor workplace conditions in many industries and support enhanced enforcement by responsible regulatory agencies. In collaboration with university and community partners, the San Francisco Department of Public Health used an observational checklist to assess preventable occupational injury hazards and compliance with employee notification requirements in 106 restaurants in San Francisco's Chinatown. Sixty-five percent of restaurants had not posted required minimum wage, paid sick leave, or workers' compensation notifications; 82% of restaurants lacked fully stocked first-aid kits; 52% lacked antislip mats; 37% lacked adequate ventilation; and 28% lacked adequate lighting. Supported by a larger community-based participatory research process, this pilot project helped to spur additional innovative health department collaborations to promote healthier workplaces. PMID:21836739

  20. 77 FR 43090 - Safety and Occupational Health Study Section: Notice of Charter Renewal

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-23

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Safety and Occupational Health Study Section... October 6, 1972, that the Safety and Occupational Health Study Section, Centers for Disease Control...

  1. 75 FR 42455 - Safety and Occupational Health Study Section: Notice of Charter Renewal

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-21

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Safety and Occupational Health Study Section... October 6, 1972, that the Safety and Occupational Health Study Section, Centers for Disease Control...

  2. 40 CFR 720.90 - Data from health and safety studies.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 31 2011-07-01 2011-07-01 false Data from health and safety studies. 720.90 Section 720.90 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC... Data from health and safety studies. (a) Information other than specific chemical identity. Except...

  3. 40 CFR 720.90 - Data from health and safety studies.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 32 2012-07-01 2012-07-01 false Data from health and safety studies. 720.90 Section 720.90 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT PREMANUFACTURE NOTIFICATION Confidentiality and Public Access to Information § 720.90 Data from health and safety studies....

  4. A cross-sectional study to identify organisational processes associated with nurse-reported quality and patient safety

    PubMed Central

    Tvedt, Christine; Sjetne, Ingeborg Strømseng; Helgeland, Jon; Bukholm, Geir

    2012-01-01

    Objectives The purpose of this study was to identify organisational processes and structures that are associated with nurse-reported patient safety and quality of nursing. Design This is an observational cross-sectional study using survey methods. Setting Respondents from 31 Norwegian hospitals with more than 85 beds were included in the survey. Participants All registered nurses working in direct patient care in a position of 20% or more were invited to answer the survey. In this study, 3618 nurses from surgical and medical wards responded (response rate 58.9). Nurses' practice environment was defined as organisational processes and measured by the Nursing Work Index Revised and items from Hospital Survey on Patient Safety Culture. Outcome measures Nurses' assessments of patient safety, quality of nursing, confidence in how their patients manage after discharge and frequency of adverse events were used as outcome measures. Results Quality system, nurse–physician relation, patient safety management and staff adequacy were process measures associated with nurse-reported work-related and patient-related outcomes, but we found no associations with nurse participation, education and career and ward leadership. Most organisational structures were non-significant in the multilevel model except for nurses’ affiliations to medical department and hospital type. Conclusions Organisational structures may have minor impact on how nurses perceive work-related and patient-related outcomes, but the findings in this study indicate that there is a considerable potential to address organisational design in improvement of patient safety and quality of care. PMID:23263021

  5. Preclinical safety studies on autologous cultured human skin fibroblast transplantation.

    PubMed

    Zeng, Wei; Zhang, Shuying; Liu, Dai; Chai, Mi; Wang, Jiaqi; Zhao, Yuming

    2014-01-01

    Recently, FDA approved the clinical use of autologous fibroblasts (LAVIV™) for the improvement of nasolabial fold wrinkles in adults. The use of autologous fibroblasts for the augmentation of dermal and subcutaneous defects represents a potentially exciting natural alternative to the use of other filler materials for its long-term corrective ability and absence of allergic adverse effects proved by clinical application. However, compared to the clinical evidence, preclinical studies are far from enough. In this study, human skin-derived fibroblasts were cultured and expanded for both in vitro and in vivo observations. In vitro, the subcultured fibroblasts were divided into two groups. One set of cells underwent cell cycle and karyotype analysis at passages 5 and 10. The second group of cells was cocultured in medium with different concentrations of human skin extract D for the measurement of collagen concentration and cell count. In vivo, the subcultured fibroblasts were injected into nude mice subcutaneously. Biopsies were taken for morphology observation and specific collagen staining at 1, 2, and 3 months after injection. The results in vitro showed no significant differences in cell cycle distribution between passages 5 and 10. Cell proliferation and secretion were inhibited as the concentration of extract D increased. In vivo, the fibroblasts were remarkably denser on the experimental side with no dysplastic cells. Mitotic cells were easily observed at the end of the first month but were rare at the end of the third month. Type III collagen was detected at the end of the first month, while collagen type I was positive at the end of the second month. The content of both collagens increased as time passed. The above results indicated that the use of the autologous fibroblasts was safe, providing a basic support for clinical use of fibroblasts. PMID:23211390

  6. How effective are patient safety initiatives? A retrospective patient record review study of changes to patient safety over time

    PubMed Central

    Baines, Rebecca; Langelaan, Maaike; de Bruijne, Martine; Spreeuwenberg, Peter; Wagner, Cordula

    2015-01-01

    Objectives To assess whether, compared with previous years, hospital care became safer in 2011/2012, expressing itself in a fall in preventable adverse event (AE) rates alongside patient safety initiatives. Design Retrospective patient record review at three points in time. Setting In three national AE studies, patient records of 2004, 2008 and 2011/2012 were reviewed in, respectively, 21 hospitals in 2004, 20 hospitals in 2008 and 20 hospitals in 2011/2012. In each hospital, 400, 200 and 200 patient records were sampled, respectively. Participants In total, 15 997 patient admissions were included in the study, 7926 patient admissions from 2004, 4023 from 2008 and 4048 from 2011/2012. Interventions The main patient safety initiatives in hospital care at a national level between 2004 and 2012 have been small as well as large-scale multifaceted programmes. Main outcome measures Rates of both AEs and preventable AEs. Results Uncorrected crude overall AE rates showed no change in 2011/2012 in comparison with 2008, whereas preventable AE rates showed a reduction of 45%. After multilevel corrections, the decrease in preventable AE rate in 2011/2012 was still clearly visible with a decrease of 30% in comparison to 2008 (p=0.10). In 2011/2012, fewer preventable AEs were found in older age groups, or related to the surgical process, in comparison with 2008. Conclusions Our study shows some improvements in preventable AEs in the areas that were addressed during the comprehensive national safety programme. There are signs that such a programme has a positive impact on patient safety. PMID:26150548

  7. Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Final rule.

    PubMed

    2010-09-29

    The Food and Drug Administration (FDA) is amending its regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND). The final rule codifies the agency's expectations for timely review, evaluation, and submission of relevant and useful safety information and implements internationally harmonized definitions and reporting standards. The revisions will improve the utility of IND safety reports, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the drug, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, subject bioavailability and bioequivalence studies to safety reporting requirements, promote a consistent approach to safety reporting internationally, and enable the agency to better protect and promote public health. PMID:20879180

  8. Postmarketing Safety Study Tool: A Web Based, Dynamic, and Interoperable System for Postmarketing Drug Surveillance Studies

    PubMed Central

    Sinaci, A. Anil; Laleci Erturkmen, Gokce B.; Gonul, Suat; Yuksel, Mustafa; Invernizzi, Paolo; Thakrar, Bharat; Pacaci, Anil; Cinar, H. Alper; Cicekli, Nihan Kesim

    2015-01-01

    Postmarketing drug surveillance is a crucial aspect of the clinical research activities in pharmacovigilance and pharmacoepidemiology. Successful utilization of available Electronic Health Record (EHR) data can complement and strengthen postmarketing safety studies. In terms of the secondary use of EHRs, access and analysis of patient data across different domains are a critical factor; we address this data interoperability problem between EHR systems and clinical research systems in this paper. We demonstrate that this problem can be solved in an upper level with the use of common data elements in a standardized fashion so that clinical researchers can work with different EHR systems independently of the underlying information model. Postmarketing Safety Study Tool lets the clinical researchers extract data from different EHR systems by designing data collection set schemas through common data elements. The tool interacts with a semantic metadata registry through IHE data element exchange profile. Postmarketing Safety Study Tool and its supporting components have been implemented and deployed on the central data warehouse of the Lombardy region, Italy, which contains anonymized records of about 16 million patients with over 10-year longitudinal data on average. Clinical researchers in Roche validate the tool with real life use cases. PMID:26543873

  9. Postmarketing Safety Study Tool: A Web Based, Dynamic, and Interoperable System for Postmarketing Drug Surveillance Studies.

    PubMed

    Sinaci, A Anil; Laleci Erturkmen, Gokce B; Gonul, Suat; Yuksel, Mustafa; Invernizzi, Paolo; Thakrar, Bharat; Pacaci, Anil; Cinar, H Alper; Cicekli, Nihan Kesim

    2015-01-01

    Postmarketing drug surveillance is a crucial aspect of the clinical research activities in pharmacovigilance and pharmacoepidemiology. Successful utilization of available Electronic Health Record (EHR) data can complement and strengthen postmarketing safety studies. In terms of the secondary use of EHRs, access and analysis of patient data across different domains are a critical factor; we address this data interoperability problem between EHR systems and clinical research systems in this paper. We demonstrate that this problem can be solved in an upper level with the use of common data elements in a standardized fashion so that clinical researchers can work with different EHR systems independently of the underlying information model. Postmarketing Safety Study Tool lets the clinical researchers extract data from different EHR systems by designing data collection set schemas through common data elements. The tool interacts with a semantic metadata registry through IHE data element exchange profile. Postmarketing Safety Study Tool and its supporting components have been implemented and deployed on the central data warehouse of the Lombardy region, Italy, which contains anonymized records of about 16 million patients with over 10-year longitudinal data on average. Clinical researchers in Roche validate the tool with real life use cases. PMID:26543873

  10. Assessing the home fire safety of urban older adults: a case study.

    PubMed

    Twyman, Stephanie; Fahey, Erin; Lehna, Carlee

    2014-01-01

    Older adults are at a higher risk for fatal house fire injury due to decreased mobility, chronic illness, and lack of smoke alarms. The purpose of this illustrative case study is to describe the home fire safety (HFS) status of an urban older adult who participated in a large study funded by the Federal Emergency Management Agency (FEMA). During a home visit with the participant, HFS data were collected from documents, observation, physical artifacts, reflective logs, and interviews. Numerous HFS hazards were identified including non-working smoke alarms, inadequate number and inappropriate placement of smoke alarms, lack of carbon monoxide (CO) alarms, inability to identify a home fire escape plan, hot water heater temperature set too high, and cooking hazards. Identification of HFS risk factors will assist in the development of educational materials that can be tailored to the older adult population to decrease their risk of fire-related injuries and death. PMID:25362758

  11. Indicators of Faculty and Staff Perceptions of Campus Safety: A Case Study

    ERIC Educational Resources Information Center

    Woolfolk, Willie A.

    2013-01-01

    The study addressed the problem of a critical increase in campus crime between 1999 and 2009, a period during which overall crime in the United States declined. Further the research explored the perceptions of campus safety among faculty and staff at an institution where campus safety initiatives are nationally ranked as exemplary and incidents of…

  12. 75 FR 29754 - Claims of Confidentiality of Certain Chemical Identities Contained in Health and Safety Studies...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-27

    ..., 2010 (75 FR 3462) (FRL-8807-9), EPA announced that `` here a health and safety study submitted under... chemical substances of unknown or variable composition, complex reaction products and biological materials... AGENCY Claims of Confidentiality of Certain Chemical Identities Contained in Health and Safety...

  13. Challenges in translating endpoints from trials to observational cohort studies in oncology

    PubMed Central

    Ording, Anne Gulbech; Cronin-Fenton, Deirdre; Ehrenstein, Vera; Lash, Timothy L; Acquavella, John; Rørth, Mikael; Sørensen, Henrik Toft

    2016-01-01

    Clinical trials are considered the gold standard for examining drug efficacy and for approval of new drugs. Medical databases and population surveillance registries are valuable resources for post-approval observational research, which are increasingly used in studies of benefits and risk of new cancer drugs. Here, we address the challenges in translating endpoints from oncology trials to observational studies. Registry-based cohort studies can investigate real-world safety issues – including previously unrecognized concerns – by examining rare endpoints or multiple endpoints at once. In contrast to clinical trials, observational cohort studies typically do not exclude real-world patients from clinical practice, such as old and frail patients with comorbidity. The observational cohort study complements the clinical trial by examining the effectiveness of interventions applied in clinical practice and by providing evidence on long-term clinical outcomes, which are often not feasible to study in a clinical trial. Various endpoints can be included in clinical trials, such as hard endpoints, soft endpoints, surrogate endpoints, and patient-reported endpoints. Each endpoint has it strengths and limitations for use in research studies. Endpoints used in oncology trials are often not applicable in observational cohort studies which are limited by the setting of standard clinical practice and by non-standardized endpoint determination. Observational studies can be more helpful moving research forward if they restrict focus to appropriate and valid endpoints. PMID:27354827

  14. On the safety of aircraft systems: A case study

    SciTech Connect

    Martinez-Guridi, G.; Hall, R.E.; Fullwood, R.R.

    1997-05-14

    An airplane is a highly engineered system incorporating control- and feedback-loops which often, and realistically, are non-linear because the equations describing such feedback contain products of state variables, trigonometric or square-root functions, or other types of non-linear terms. The feedback provided by the pilot (crew) of the airplane also is typically non-linear because it has the same mathematical characteristics. An airplane is designed with systems to prevent and mitigate undesired events. If an undesired triggering event occurs, an accident may process in different ways depending on the effectiveness of such systems. In addition, the progression of some accidents requires that the operating crew take corrective action(s), which may modify the configuration of some systems. The safety assessment of an aircraft system typically is carried out using ARP (Aerospace Recommended Practice) 4761 (SAE, 1995) methods, such as Fault Tree Analysis (FTA) and Failure Mode and Effects Analysis (FMEA). Such methods may be called static because they model an aircraft system on its nominal configuration during a mission time, but they do not incorporate the action(s) taken by the operating crew, nor the dynamic behavior (non-linearities) of the system (airplane) as a function of time. Probabilistic Safety Assessment (PSA), also known as Probabilistic Risk Assessment (PRA), has been applied to highly engineered systems, such as aircraft and nuclear power plants. PSA encompasses a wide variety of methods, including event tree analysis (ETA), FTA, and common-cause analysis, among others. PSA should not be confused with ARP 4761`s proposed PSSA (Preliminary System Safety Assessment); as its name implies, PSSA is a preliminary assessment at the system level consisting of FTA and FMEA.

  15. Multiphase problems related to safety studies in the process industries

    NASA Astrophysics Data System (ADS)

    Baron, R. Grollier

    Safety risk and analysis, particularly in the petrochemical industry, are discussed. Multiphase flow problems resulting from loss of confinement are described: rupture of long pipes used for transporting liquefied gas; rupture of short pipes and branch connections in an installation; rupture of a container holding liquefied gas or another liquid at a temperature higher than its normal boiling temperature; and rupture of a container holding gas in the supercritical state. Operation of valves and rupture disks during reaction runaway; and artificial dispersion of gas layers are considered.

  16. System Study: High-Pressure Safety Injection 1998-2014

    SciTech Connect

    Schroeder, John Alton

    2015-12-01

    This report presents an unreliability evaluation of the high-pressure safety injection system (HPSI) at 69 U.S. commercial nuclear power plants. Demand, run hours, and failure data from fiscal year 1998 through 2014 for selected components were obtained from the Institute of Nuclear Power Operations (INPO) Consolidated Events Database (ICES). The unreliability results are trended for the most recent 10 year period, while yearly estimates for system unreliability are provided for the entire active period. No statistically significant increasing or decreasing trends were identified in the HPSI results.

  17. Technology Solutions Case Study: Combustion Safety Simplified Test Protocol

    SciTech Connect

    L. Brand, D. Cautley, D. Bohac, P. Francisco, L. Shen, and S. Gloss

    2015-12-01

    Combustions safety is an important step in the process of upgrading homes for energy efficiency. There are several approaches used by field practitioners, but researchers have indicated that the test procedures in use are complex to implement and provide too many false positives. Field failures often mean that the house is not upgraded until after remediation or not at all, if not include in the program. In this report the PARR and NorthernSTAR DOE Building America Teams provide a simplified test procedure that is easier to implement and should produce fewer false positives.

  18. System Study: High-Pressure Safety Injection 1998–2013

    SciTech Connect

    Schroeder, John Alton

    2015-02-01

    This report presents an unreliability evaluation of the high-pressure safety injection system (HPSI) at 69 U.S. commercial nuclear power plants. Demand, run hours, and failure data from fiscal year 1998 through 2013 for selected components were obtained from the Institute of Nuclear Power Operations (INPO) Consolidated Events Database (ICES). The unreliability results are trended for the most recent 10-year period while yearly estimates for system unreliability are provided for the entire active period. No statistically significant increasing or decreasing trends were identified in the HPSI results.

  19. System Study: High-Pressure Safety Injection 1998–2012

    SciTech Connect

    T. E. Wierman

    2013-10-01

    This report presents an unreliability evaluation of the high-pressure safety injection system (HPSI) at 69 U.S. commercial nuclear power plants. Demand, run hours, and failure data from fiscal year 1998 through 2012 for selected components were obtained from the Equipment Performance and Information Exchange (EPIX). The unreliability results are trended for the most recent 10 year period while yearly estimates for system unreliability are provided for the entire active period. No statistically significant increasing or decreasing trends were identified in the HPSI results.

  20. Safety Culture Assessment in Petrochemical Industry: A Comparative Study of Two Algerian Plants

    PubMed Central

    Boughaba, Assia; Hassane, Chabane; Roukia, Ouddai

    2014-01-01

    Background To elucidate the relationship between safety culture maturity and safety performance of a particular company. Methods To identify the factors that contribute to a safety culture, a survey questionnaire was created based mainly on the studies of Fernández-Muñiz et al. The survey was randomly distributed to 1000 employees of two oil companies and realized a rate of valid answer of 51%. Minitab 16 software was used and diverse tests, including the descriptive statistical analysis, factor analysis, reliability analysis, mean analysis, and correlation, were used for the analysis of data. Ten factors were extracted using the analysis of factor to represent safety culture and safety performance. Results The results of this study showed that the managers' commitment, training, incentives, communication, and employee involvement are the priority domains on which it is necessary to stress the effort of improvement, where they had all the descriptive average values lower than 3.0 at the level of Company B. Furthermore, the results also showed that the safety culture influences the safety performance of the company. Therefore, Company A with a good safety culture (the descriptive average values more than 4.0), is more successful than Company B in terms of accident rates. Conclusion The comparison between the two petrochemical plants of the group Sonatrach confirms these results in which Company A, the managers of which are English and Norwegian, distinguishes itself by the maturity of their safety culture has significantly higher evaluations than the company B, who is constituted of Algerian staff, in terms of safety management practices and safety performance. PMID:25180135

  1. EVOLVE (nebivolol evaluation for efficacy and safety in the treatment of hypertension) postmarketing surveillance study.

    PubMed

    Faruqui, Arif A

    2007-05-01

    The objective of EVOLVE [nebivolol (nevol) evaluation for efficacy and safety in the treatment of hypertension], a postmarketing surveillance (PMS) study is to identify, validate and quantify the safety and efficacy associated with the use of nebivolol. EVOLVE study was an open-label, non-comparative, prospective, one month follow-up study of 301 patients of either sex with stage 1 hypertension, as defined by the JNC VII guidelines. The data was collected from 27 centres from all over India during the period August, 2006 to December, 2006. Nebivolol (2.5-5 mg/day) was given for 1 month. Clinical assessment was done at the start of the treatment and at 15th day and 30th day follow-ups. Concomitant medications administered were also recorded. Baseline mean systolic blood pressure (SBP) was 157.73 +/- 14.16 mm Hg which dropped to 135.13 +/- 11.15 mm Hg at the end of the study. At the end of 1 month treatment the change in mean SBP was 22.6 mm Hg ie, 14.32% reduction from baseline which was statistically significant (p < 0.001). Also the baseline mean diastolic blood pressure (DBP) was 97.21 +/- 8.25 mm Hg that dropped to 83.69 +/- 6.63 mm Hg at the end of the study. At the end of one month treatment the change in mean DBP was 13.52 mmHg ie, 13.9% reduction from baseline which was significant (p < 0.001). The heart rate in this study showed a significant decrease from 86.13 +/- 9.35 at basal to 75.09 +/- 7.42 at the end of the study (p < 0.001). It was observed that at the end of one month of treatment, majority of the patients ie, 97.75% of total cases showed good to excellent response to nebivolol. EVOLVE PMS study showed that nebivolol hydrochloride is very safe and only 8.2% of cases (n = 22) reported adverse effects, the commonest being dizziness (3.28%). Less than 1% patients reported nausea, constipation, headache, weakness, tiredness and pedal oedema; 99.25% of patients reported good to excellent tolerability; 82.33% patients achieved the goals recommended by

  2. Nuclear space power safety and facility guidelines study

    SciTech Connect

    Mehlman, W.F.

    1995-09-11

    This report addresses safety guidelines for space nuclear reactor power missions and was prepared by The Johns Hopkins University Applied Physics Laboratory (JHU/APL) under a Department of Energy grant, DE-FG01-94NE32180 dated 27 September 1994. This grant was based on a proposal submitted by the JHU/APL in response to an {open_quotes}Invitation for Proposals Designed to Support Federal Agencies and Commercial Interests in Meeting Special Power and Propulsion Needs for Future Space Missions{close_quotes}. The United States has not launched a nuclear reactor since SNAP 10A in April 1965 although many Radioisotope Thermoelectric Generators (RTGs) have been launched. An RTG powered system is planned for launch as part of the Cassini mission to Saturn in 1997. Recently the Ballistic Missile Defense Office (BMDO) sponsored the Nuclear Electric Propulsion Space Test Program (NEPSTP) which was to demonstrate and evaluate the Russian-built TOPAZ II nuclear reactor as a power source in space. As of late 1993 the flight portion of this program was canceled but work to investigate the attributes of the reactor were continued but at a reduced level. While the future of space nuclear power systems is uncertain there are potential space missions which would require space nuclear power systems. The differences between space nuclear power systems and RTG devices are sufficient that safety and facility requirements warrant a review in the context of the unique features of a space nuclear reactor power system.

  3. System Safety in Early Manned Space Program: A Case Study of NASA and Project Mercury

    NASA Technical Reports Server (NTRS)

    Hansen, Frederick D.; Pitts, Donald

    2005-01-01

    This case study provides a review of National Aeronautics and Space Administration s (NASA's) involvement in system safety during research and evolution from air breathing to exo-atmospheric capable flight systems culminating in the successful Project Mercury. Although NASA has been philosophically committed to the principals of system safety, this case study points out that budget and manpower constraints-as well as a variety of internal and external pressures can jeopardize even a well-designed system safety program. This study begins with a review of the evolution and early years of NASA's rise as a project lead agency and ends with the lessons learned from Project Mercury.

  4. Civility norms, safety climate, and safety outcomes: a preliminary investigation.

    PubMed

    McGonagle, Alyssa K; Walsh, Benjamin M; Kath, Lisa M; Morrow, Stephanie L

    2014-10-01

    Working environments that are both civil and safe are good for business and employee well-being. Civility has been empirically linked to such important outcomes as organizational performance and individuals' positive work-related attitudes, yet research relating civility to safety is lacking. In this study, we link perceptions of civility norms to perceptions of safety climate and safety outcomes. Drawing on social exchange theory, we proposed and tested a model in 2 samples wherein civility norms indirectly relate to safety outcomes through associations with various safety climate facets. Our results supported direct relationships between civility and management safety climate and coworker safety climate. Additionally, indirect effects of civility norms on unsafe behaviors and injuries were observed. Indirect effects of civility norms on unsafe behaviors were observed through coworker safety climate and work-safety tension. Indirect effects of civility norms on injuries were observed through management safety climate and work-safety tension for full-time employees, although these effects did not hold for part-time employees. This study provides initial evidence that researchers and practitioners may want to look beyond safety climate to civility norms to more comprehensively understand the origins of unsafe behaviors and injuries and to develop appropriate preventive interventions. PMID:24933595

  5. A safety and tolerability study of differently-charged nanoparticles for local pulmonary drug delivery

    SciTech Connect

    Harush-Frenkel, Oshrat; Bivas-Benita, Maytal; Nassar, Taher; Springer, Chaim; Sherman, Yoav; Avital, Avraham; Altschuler, Yoram; Borlak, Jurgen; Benita, Simon

    2010-07-15

    Nanoparticle (NP) based drug delivery systems provide promising opportunities in the treatment of lung diseases. Here we examined the safety and tolerability of pulmonary delivered NPs consisting of PEG-PLA as a function of particle surface charge. The rationale for such a comparison should be attributed to the differential pulmonary toxicity of positively and negatively charged PEG-PLA NP. Thus, the local and systemic effects of pulmonary administered NPs were investigated following 5 days of daily endotracheal instillation to BALB/c mice that were euthanized on the eighth or nineteenth day of the experiment. We collected bronchoalveolar lavages and studied hematological as well as histochemistry parameters. Notably, the cationic stearylamine based PEG-PLA NPs elicited increased local and systemic toxic effects both on the eighth and nineteenth day. In contrast, anionic NPs of similar size were much better tolerated with local inflammatory effects observed only on the eighth experimental day after pulmonary instillation. No systemic toxicity effect was observed although a moderate change was noted in the platelet count that was not considered to be of clinical significance. No pathological observations were detected in the internal organs following instillation of anionic NPs. Overall these observations suggest that anionic PEG-PLA NPs are useful pulmonary drug carriers that should be considered as a promising therapeutic drug delivery system.

  6. A study on the necessity of medical facilities safety design adoption.

    PubMed

    Park, Bora; Yang, Yeongae; Yang, Dongjoo; Shin, Joong-Il; Park, Sujong; Park, Soohee; Park, Yunhee

    2013-07-01

    [Purpose] The purpose of this study was to investigate the requirements of the introduction of a safety design and certification system for medical facilities. [Subjects] A survey was carried out of one hundred nurses, physical therapists, occupational therapists, speech and language therapists from May to August in 2012. [Methods] The survey was conducted after giving subjects some information about safety design. [Results] The participants were aware of the need for establishing a safety design certification system. Total responses to services, facilities and space were analyzed in order to evaluate the priorities of safety, user characteristics, functionality, convenience and aesthetics. Regarding the application of a safety design certification system to services, items were prioritized in the order of children's items, household supplies and hospital supplies. For facilities, the priorities were, living space, social welfare and medical facilities; space, they were public and transportation-related places. The requirements for operating a safety design system were in order development of: highly skilled manpower, the legal system, educational promotion and qualifying facilities. [Conclusion] In conclusion, in order to implement safety design in medical facilities, a safety design certification system should be introduced first, and to do this a systematic and comprehensive study is needed. PMID:24259877

  7. In-Hospital Recruitment to Observational Studies of Stroke

    ERIC Educational Resources Information Center

    Pickering, Ruth M.; Kunkel, Dorit; Fitton, Carolyn; Ashburn, Ann; Jenkinson, Damian

    2010-01-01

    The objective of this study was to examine recruitment in three observational follow-up studies of patients with stroke, focusing on reasons for nonparticipation and the role of potential factors in explaining recruitment rates. It comprised secondary analysis of the three studies. Recruitment rates varied between the studies. Between 10 and 50%…

  8. Organic tanks safety program FY95 waste aging studies

    SciTech Connect

    Camaioni, D.M.; Samuels, W.D.; Clauss, S.A.; Lenihan, B.D.; Wahl, K.L.; Campbell, J.A.; Shaw, W.J.

    1995-09-01

    This report gives the second year`s findings of a study of how thermal and radiological processes may change the composition of organic compounds in the underground tanks at Hanford. Efforts were focused on the global reaction kinetics in a simulated waste exposed to {gamma} rays and the reactions of organic radicals with nitrite ion. The gas production is predominantly radiolytic. Decarboxylation of carboxylates is probably an aging pathway. TBP was totaly consumed in almost every run. Radiation clearly accelerated consumption of the other compounds. EDTA is more reactive than citrate. Oximes and possibly organic nitro compounds are key intermediates in the radiolytic redox reactions of organic compounds with nitrate/nitrite. Observations are consistent with organic compounds being progressively degraded to compounds with greater numbers of C-O bonds and fewer C-H and C-C bonds, resulting in an overall lower energy content. If the radwaste tanks are adequately ventilated and continually dosed by radioactivity, their total energy content should have declined. Level of risk depends on how rapidly carboxylate salts of moderate energy content (including EDTA fragments) degrade to low energy oxalate and formate.

  9. [Studies and safety evaluation of aflatoxins in herbal plants].

    PubMed

    Ledzion, Ewa; Rybińska, Krystyna; Postupolski, Jacek; Kurpińska-Jaworska, Jolanta; Szczesna, Małgorzata

    2011-01-01

    Herbs and herbal products are commonly used in food and pharmaceutical industries. The aim of this study was to test herbal plants for contamination with aflatoxins (AF), genotoxic, cancerogenic and hepatotoxic compounds which can cause immunotoxic and allergic effects as well as growth disorders. Aflatoxins were determined by high performance liquid chromatography (HPLC) with post column derivatization involving bromination with pyridinium hydrobromide perbromide (PBPB). Extracts was cleaned-up by immunoaffinity columns (IAC). The contents of aflatoxins B, B, G, and G, in more than 500 herbal plants samples mainly from Eastern Poland were investigated. Samples were supplied by manufacturers (herbal facilities) in 2006-2010 years. In all the evaluated samples the levels of aflatoxins above the detection limits of methods applied were not observed: for AF B1--0.2 microg/kg; AF B2--0.03 microg/kg; AF G1--0.3 microg/kg; AF G2--0.03 microg/kg (PN-EN 14123) and for AF B1--0.15 microg/kg (Ph. Eur.6, 2008:2.8.18). All the herbal plants tested for contamination with aflatoxins should be considered safe, which indicates that manufacturers used good manufacturing practices during drying and storage of raw materials. PMID:22435291

  10. A longitudinal, multi-level comparative study of quality and safety in European hospitals: the QUASER study protocol

    PubMed Central

    2011-01-01

    Background although there is a wealth of information available about quality improvement tools and techniques in healthcare there is little understanding about overcoming the challenges of day-to-day implementation in complex organisations like hospitals. The 'Quality and Safety in Europe by Research' (QUASER) study will investigate how hospitals implement, spread and sustain quality improvement, including the difficulties they face and how they overcome them. The overall aim of the study is to explore relationships between the organisational and cultural characteristics of hospitals and how these impact on the quality of health care; the findings will be designed to help policy makers, payers and hospital managers understand the factors and processes that enable hospitals in Europe to achieve-and sustain-high quality services for their patients. Methods/design in-depth multi-level (macro, meso and micro-system) analysis of healthcare quality policies and practices in 5 European countries, including longitudinal case studies in a purposive sample of 10 hospitals. The project design has three major features: • a working definition of quality comprising three components: clinical effectiveness, patient safety and patient experience • a conceptualisation of quality as a human, social, technical and organisational accomplishment • an emphasis on translational research that is evidence-based and seeks to provide strategic and practical guidance for hospital practitioners and health care policy makers in the European Union. Throughout the study we will adopt a mixed methods approach, including qualitative (in-depth, narrative-based, ethnographic case studies using interviews, and direct non-participant observation of organisational processes) and quantitative research (secondary analysis of safety and quality data, for example: adverse incident reporting; patient complaints and claims). Discussion the protocol is based on the premise that future research, policy

  11. A feasibility study of a high-safety microcontroller

    NASA Astrophysics Data System (ADS)

    Chaumontet, Gilles

    A MAPS microcontroller was designed for railway signalling, using an online and offline self test integrated logic circuit, in conformity with the Unified Built In Self Test (UBIST) technique. An output port is fitted to MAPS, in order to produce failsafe frequency modulated drive signals. An interface is used, which is designed for only accepting external signals which have been recast into a failsafe format. These two interfaces were integrated on the same chip as the self checking circuit, and are strongly failsafe. A new approach to the design of highly critical systems is given, yielding at the same time a higher safety factor than the one given by present systems for less bulk and lower cost.

  12. Ferrocyanide Safety Program cyanide speciation studies. Final report

    SciTech Connect

    Bryan, S.A.; Pool, K.H.; Bryan, S.L.

    1995-07-01

    This report summarizes Pacific Northwest Laboratory`s fiscal year (FY) 1995 progress toward developing and implementing methods to identify and quantify cyanide species in ferrocyanide tank waste. This work was conducted for Westinghouse Hanfbrd Company`s (WHC`s) Ferrocyanide Safety Program. Currently, there are 18 high-level waste storage tanks at the US Department of Energy`s Hanford Site that are on a Ferrocyanide Tank Watchlist because they contain an estimated 1000 g-moles or more of precipitated ferrocyanide. In the presence of oxidizing material such as sodium nitrate or nitrite, ferrocyanide can be made to react exothermally by heating it to high temperatures or by applying an electrical spark of sufficient energy (Cady 1993). However, fuel, oxidizers, and temperature are all important parameters. If fuel, oxidizers, or high temperatures (initiators) are not present in sufficient amounts, then a runaway or propagating reaction cannot occur. To bound the safety concern, methods are needed to definitively measure and quantitate ferrocyanide concentration present within the actual waste. The target analyte concentration for cyanide in waste is approximately 0.1 to 15 wt % (as cyanide) in the original undiluted sample. After dissolution of the original sample and appropriate dilutions, the concentration range of interest in the analytical solutions can vary between 0.001 to 0.1 wt % (as cyanide). In FY 1992, 1993, and 1994, two solution (wet) methods were developed based on Fourier transform infrared (FTIR) spectroscopy and ion chromatography (IC); these methods were chosen for further development activities. The results of these activities are described.

  13. Safety assessment of methanol extract of red dragon fruit (Hylocereus polyrhizus): acute and subchronic toxicity studies.

    PubMed

    Hor, Sook Yee; Ahmad, Mariam; Farsi, Elham; Yam, Mun Fei; Hashim, Mohd Akmal; Lim, Chung Pin; Sadikun, Amirin; Asmawi, Mohd Zaini

    2012-06-01

    Recently, the fruits of Hylocereus polyrhizus, known as red dragon fruit, have received much attention from growers worldwide. However, there is little toxicological information regarding the safety of repeated exposure to these fruits. The present study evaluated the potential toxicity of a methanol extract of H. polyrhizus fruit after acute and subchronic administration in rats. In the acute toxicity study, single doses of fruit extract (1250, 2500 and 5000 mg/kg) were administered to rats by oral gavage, and the rats were then monitored for 14 days. In the subchronic toxicity study, the fruit extract was administered orally to rats at doses of 1250, 2500 and 5000 mg/kg/day for 28 days. There was no mortality or signs of acute or subchronic toxicity. There was no significant difference in body weight, relative organ weight or hematological parameters in the subchronic toxicity study. Biochemical analysis showed some significant changes, including creatinine, globulin, total protein and urea levels. No abnormality of internal organs was observed between treatment and control groups. The lethal oral dose of the fruit extract is more than 5000 mg/kg and the no-observed-adverse-effect level (NOAEL) of the extract for both male and female rats is considered to be 5000 mg/kg per day for 28 days. PMID:22440551

  14. MOOSES: Multiple Option Observation System for Experimental Studies.

    ERIC Educational Resources Information Center

    Tapp, Jon; Wehby, Joseph

    The Multiple Option Observation System for Experimental Studies (MOOSES) is a flexible data collection and analysis package for applied behavioral research that addresses the needs of researchers interested in live coding of observational data. MOOSES allows the researcher to design a coding system for a particular research question. General types…

  15. An Observational Study of Skilled Memory in Waitresses.

    ERIC Educational Resources Information Center

    Stevens, Joy

    A two-phase study about skilled memory as it is used by waitresses included a participant-observer phase and an observational phase. Participants were three experienced waitresses who had worked at a midtown Manhattan restaurant for 14, 7, and 3 years respectively and a team of 5 confederate customers. Waitresses and customers wore microphones.…

  16. A hybrid simulation approach for integrating safety behavior into construction planning: An earthmoving case study.

    PubMed

    Goh, Yang Miang; Askar Ali, Mohamed Jawad

    2016-08-01

    One of the key challenges in improving construction safety and health is the management of safety behavior. From a system point of view, workers work unsafely due to system level issues such as poor safety culture, excessive production pressure, inadequate allocation of resources and time and lack of training. These systemic issues should be eradicated or minimized during planning. However, there is a lack of detailed planning tools to help managers assess the impact of their upstream decisions on worker safety behavior. Even though simulation had been used in construction planning, the review conducted in this study showed that construction safety management research had not been exploiting the potential of simulation techniques. Thus, a hybrid simulation framework is proposed to facilitate integration of safety management considerations into construction activity simulation. The hybrid framework consists of discrete event simulation (DES) as the core, but heterogeneous, interactive and intelligent (able to make decisions) agents replace traditional entities and resources. In addition, some of the cognitive processes and physiological aspects of agents are captured using system dynamics (SD) approach. The combination of DES, agent-based simulation (ABS) and SD allows a more "natural" representation of the complex dynamics in construction activities. The proposed hybrid framework was demonstrated using a hypothetical case study. In addition, due to the lack of application of factorial experiment approach in safety management simulation, the case study demonstrated sensitivity analysis and factorial experiment to guide future research. PMID:26456000

  17. Lessons from the TAPS study. Warfarin: a major cause of threats to patient safety.

    PubMed

    Makeham, Meredith A B; Saltman, Deborah C; Kidd, Michael R

    2008-10-01

    The Threats to Australian Patient Safety (TAPS) study collected 648 anonymous reports about threats to patient safety from a representative random sample of Australian general practitioners. These contained any events the GPs felt should not have happened, and would not want to happen again, regardless of who was at fault or the outcome of the event. This series of articles presents clinical lessons resulting from the TAPS study. PMID:19002300

  18. Economic deregulation and transport safety: a synthesis of evidence from evaluation studies.

    PubMed

    Elvik, Rune

    2006-07-01

    This paper presents a synthesis of evidence from studies that have evaluated the impacts of economic deregulation on transport safety. Most of these studies refer to aviation or road transport. Very few studies deal with deregulation of rail transport. There are no studies of maritime transport, which has never been regulated the same way as other modes of transport. The review includes studies that have attempted to quantify the impacts of transport deregulation on transport safety. Each study contains one or more estimates of the effect on transport safety of deregulation. Summary estimates of effect have been derived from the individual estimates of effect by means of meta-analysis. Airline deregulation, which has only been evaluated in the United States, does not appear to influence the safety of air travel. Deregulation of road transport has been evaluated in several countries. The summary estimate of effect indicates that no statistically significant changes in road safety have occurred as a result of deregulation. Deregulation of rail transport has only been evaluated in Great Britain and the United States. The experience so far suggests that deregulation of railways is associated with improved rail safety. This association does, however, not necessarily imply a causal relationship. PMID:16427020

  19. Vaccine Safety

    MedlinePlus

    ... During Pregnancy Frequently Asked Questions about Vaccine Recalls Historical Vaccine Safety Concerns FAQs about GBS and Menactra ... CISA Resources for Healthcare Professionals Evaluation Current Studies Historical Background 2001-12 Publications Technical Reports Vaccine Safety ...

  20. Sensemaking and the co-production of safety: a qualitative study of primary medical care patients.

    PubMed

    Rhodes, Penny; McDonald, Ruth; Campbell, Stephen; Daker-White, Gavin; Sanders, Caroline

    2016-02-01

    This study explores the ways in which patients make sense of 'safety' in the context of primary medical care. Drawing on qualitative interviews with primary care patients, we reveal patients' conceptualisation of safety as fluid, contingent, multi-dimensional, and negotiated. Participant accounts drew attention to a largely invisible and inaccessible (but taken for granted) architecture of safety, the importance of psycho-social as well as physical dimensions and the interactions between them, informal strategies for negotiating safety, and the moral dimension of safety. Participants reported being proactive in taking action to protect themselves from potential harm. The somewhat routinised and predictable nature of the primary medical care consultation, which is very different from 'one off' inpatient spells, meant that patients were not passive recipients of care. Instead they had a stock of accumulated knowledge and experience to inform their actions. In addition to highlighting the differences and similarities between hospital and primary care settings, the study suggests that a broad conceptualisation of patient safety is required, which encompasses the safety concerns of patients in primary care settings. PMID:26547907

  1. STRengthening Analytical Thinking for Observational Studies: the STRATOS initiative

    PubMed Central

    Sauerbrei, Willi; Abrahamowicz, Michal; Altman, Douglas G; le Cessie, Saskia; Carpenter, James

    2014-01-01

    The validity and practical utility of observational medical research depends critically on good study design, excellent data quality, appropriate statistical methods and accurate interpretation of results. Statistical methodology has seen substantial development in recent times. Unfortunately, many of these methodological developments are ignored in practice. Consequently, design and analysis of observational studies often exhibit serious weaknesses. The lack of guidance on vital practical issues discourages many applied researchers from using more sophisticated and possibly more appropriate methods when analyzing observational studies. Furthermore, many analyses are conducted by researchers with a relatively weak statistical background and limited experience in using statistical methodology and software. Consequently, even ‘standard’ analyses reported in the medical literature are often flawed, casting doubt on their results and conclusions. An efficient way to help researchers to keep up with recent methodological developments is to develop guidance documents that are spread to the research community at large. These observations led to the initiation of the strengthening analytical thinking for observational studies (STRATOS) initiative, a large collaboration of experts in many different areas of biostatistical research. The objective of STRATOS is to provide accessible and accurate guidance in the design and analysis of observational studies. The guidance is intended for applied statisticians and other data analysts with varying levels of statistical education, experience and interests. In this article, we introduce the STRATOS initiative and its main aims, present the need for guidance documents and outline the planned approach and progress so far. We encourage other biostatisticians to become involved. PMID:25074480

  2. Development of nanostructured phosphorite: Study of the safety of application.

    PubMed

    Ezhkova, A M; Yapparov, A Kh; Ezhkov, V O; Bikkinina, L M-Kh; Yapparov, I A; Gerasimov, A P

    2016-03-01

    A nanostructured mineral food supplement with a particle size of 60.0-120.0 nm was manufactured from phosphorite by ultrasonic dispersion. It was found that intragastric administration of nanostructures phosphorite to mice is relatively safe: clinical signs of intoxication appeared after a single administration of the preparation only at a dose of 90 mg/kg; a dose of 150 mg/kg caused death of 8% of mice, in which injuries of organs of the gastrointestinal tract were observed. When the preparation was administered subcutaneously, intramuscularly, or intraperitoneally, small phosphorite conglomerates and inflammation of the surrounding tissues and organs were observed at the injection site. Death of 25% of animals was observed in the group of mice which received intraperitoneal injections of nanophosphorite at a dose of 200 mg/kg. PMID:27193878

  3. Tritium safety study using Caisson Assembly (CATS) at TPL/JAEA

    SciTech Connect

    Hayashi, T.; Kobayashi, K.; Iwai, Y.; Isobe, K.; Nakamura, H.; Kawamura, Y.; Shu, W.; Suzuki, T.; Yamada, M.; Yamanishi, T.

    2008-07-15

    Tritium confinement is required as the most important safety Junction for a fusion reactor. In order to demonstrate the confinement performance experimentally, an unique equipment, called CATS: Caisson Assembly for Tritium Safety study, was installed in Tritium Process Laboratory of Japan Atomic Energy Agency and operated for about 10 years. Tritium confinement and migration data in CATS have been accumulated and dynamic simulation code was accumulated using these data. Contamination and decontamination behavior on various materials and new safety equipment functions have been investigated under collaborations with a lot of laboratories and universities. (authors)

  4. Safety and Efficacy of Ferric Carboxymaltose in Anemic Pregnant Women: A Retrospective Case Control Study

    PubMed Central

    Pels, Anouk; Ganzevoort, Wessel

    2015-01-01

    Background. Anemia during pregnancy is commonly caused by iron deficiency and can have severe consequences for both the mother and the developing fetus. The aim of this retrospective study was to assess the safety and efficacy of intravenous ferric carboxymaltose (FCM) in pregnant women. Methods. All women treated with FCM for anemia during pregnancy between 2010 and 2012 at our institution were included. A matched control group was selected, including women who either were nonanemic or had anemia but were not considered for intravenous iron. Main outcome measures were maternal safety and pregnancy outcomes. Results. The study included 128 patients (FCM: 64; control: 64). Median FCM dose was 1000 mg and median gestational age at the time of first treatment was 34 weeks and 6 days. Median Hb increased from 8.4 g/dL (interquartile range 7.7; 8.9 g/dL) at the first FCM administration to 10.7 g/dL (9.8; 11.5 g/dL; n = 46 with available Hb at delivery) at the time of delivery, achieving levels similar to those in the control group (10.8 g/dL [9.8; 11.8 g/dL; n = 48]). No treatment-related adverse events were reported and no statistically significant differences in pregnancy outcomes were observed between groups. Conclusions. Within the limitations of this case control study, FCM was a safe and efficient treatment of anemia during pregnancy. PMID:26688686

  5. Safety and Efficacy of Ferric Carboxymaltose in Anemic Pregnant Women: A Retrospective Case Control Study.

    PubMed

    Pels, Anouk; Ganzevoort, Wessel

    2015-01-01

    Background. Anemia during pregnancy is commonly caused by iron deficiency and can have severe consequences for both the mother and the developing fetus. The aim of this retrospective study was to assess the safety and efficacy of intravenous ferric carboxymaltose (FCM) in pregnant women. Methods. All women treated with FCM for anemia during pregnancy between 2010 and 2012 at our institution were included. A matched control group was selected, including women who either were nonanemic or had anemia but were not considered for intravenous iron. Main outcome measures were maternal safety and pregnancy outcomes. Results. The study included 128 patients (FCM: 64; control: 64). Median FCM dose was 1000 mg and median gestational age at the time of first treatment was 34 weeks and 6 days. Median Hb increased from 8.4 g/dL (interquartile range 7.7; 8.9 g/dL) at the first FCM administration to 10.7 g/dL (9.8; 11.5 g/dL; n = 46 with available Hb at delivery) at the time of delivery, achieving levels similar to those in the control group (10.8 g/dL [9.8; 11.8 g/dL; n = 48]). No treatment-related adverse events were reported and no statistically significant differences in pregnancy outcomes were observed between groups. Conclusions. Within the limitations of this case control study, FCM was a safe and efficient treatment of anemia during pregnancy. PMID:26688686

  6. Role of relatives of ethnic minority patients in patient safety in hospital care: a qualitative study

    PubMed Central

    van Rosse, Floor; Suurmond, Jeanine; Wagner, Cordula; de Bruijne, Martine; Essink-Bot, Marie-Louise

    2016-01-01

    Objective Relatives of ethnic minority patients often play an important role in the care process during hospitalisation. Our objective was to analyse the role of these relatives in relation to the safety of patients during hospital care. Setting Four large urban hospitals with an ethnic diverse patient population. Participants On hospital admission of ethnic minority patients, 20 cases were purposively sampled in which relatives were observed to play a role in the care process. Outcome measures We used documents (patient records) and added eight cases with qualitative interviews with healthcare providers, patients and/or their relatives to investigate the relation between the role of relatives and patient safety. An inductive approach followed by selective coding was used to analyse the data. Results Besides giving social support, family members took on themselves the role of the interpreter, the role of substitutes of the patient and the role of care provider. The taking over of these roles can have positive and negative effects on patient safety. Conclusions When family members take over various roles during hospitalisation of a relative, this can lead to a safety risk and a safety protection for the patient involved. Although healthcare providers should not hand over their responsibilities to the relatives of patients, optimising collaboration with relatives who are willing to take part in the care process may improve patient safety. PMID:27056588

  7. Study designs for the nonclinical safety testing of new vaccine products.

    PubMed

    Forster, Roy

    2012-07-01

    During the development of a new vaccine, the purpose of nonclinical studies is to provide safety information to support the clinical development and licensure of the product. In this article the study designs currently accepted for the nonclinical safety testing of new vaccines are described for single dose, local tolerance, repeat dose toxicity and safety pharmacology studies; these studies together form the basis of a typical nonclinical safety evaluation dossier. The detailed design of the preclinical package must take account of the intended clinical use, patient population, route of administration, formulation, dose level and immunisation schedule. The test item that is used for these studies must be adequately representative of the intended clinical formulation. The animal model used for these studies must be selected on criteria of relevance. Single dose toxicity studies provide information on acute actions or the potential effect of accidental overdose, but this information is often available from the repeat dose toxicity study, obviating the need for the acute study. Local tolerance studies provide information on tissue reactions at the site of administration. Evaluation of the findings must distinguish between normal tissue responses to injected material and findings indicative of undesirable pathological changes. The repeated dose toxicity studies are the principal studies that support the safety profile of the vaccines. The design of these studies must take full account of the features of the vaccine in the choice of treatment regime, dose levels, pharmacodynamic monitoring and timing of investigations and sacrifice. Safety pharmacology studies are performed to evaluate the potential for undesirable secondary pharmacological actions of vaccines if there is data to suggest that such studies are needed; this evaluation is made on a case by case basis. In the absence of specific guidance the design of studies for therapeutic vaccines follows the same

  8. Criticality safety study of the MSRE auxiliary charcoal bed

    SciTech Connect

    Hollenbach, D.F.; Hopper, C.M.

    1996-09-01

    The Molten Salt Reactor Experiment (MSRE) was operated from June 1965 to December 1969. The objective of the experiment was to investigate the practicality of developing a power reactor consisting of a graphite lattice with circulating molten uranium salt as fuel for application in central power stations. When the experiment was terminated in 1969, approximately 4710 kg of salt containing approximately 36.3 kg of uranium, 675 g of plutonium, and various fission products were transferred to two fuel drain tanks (FDTs). The almost 30.5 kg of Uranium 233 in the salt is the primary fissile constituent, but about 0.93 kg of Uranium 235 is also present. In April 1994, a gas sample from the MSRE off-gas system (OGS) indicated that uranium had migrated from the FDTs into the OGS. Further investigation revealed a likely accumulation of approximately 2.6 kg of uranium in the auxiliary charcoal bed (ACB), which is located in the concrete-lined charcoal bed cell (CBC) below ground level outside the MSRE building. The nuclear criticality safety (NCS) situation was further complicated by the CBC being filled with water up to the overflow pipe, which completely submerged the ACB. Thus there was not only an increased risk of criticality because of water reflection in the ACB, but also because of potential moderation in the ACB in case of water inleakage. Leakage into the ACB would result in a direct path for water between the CBC and the OGS or FDTs, thus increasing the risk of criticality in these areas. When uranium was discovered in the ACB, a number of steps, detailed in this report, were immediately taken to try to understand and ameliorate the situation. After all the actions were completed, a validation of the results obtained for the ACB was performed.

  9. Toxicological study and oxidative stress evaluation for safety assessment of xylanase preparations in Wistar rats.

    PubMed

    Driss, Dorra; Soudani, Najla; Boudawara, Tahia; Zeghal, Najiba; Chaabouni, Semia Ellouze

    2014-11-01

    Acute and 90-day subchronic oral toxicity studies were conducted to establish the safety evaluation of xylanases preparations. A potential oxidative stress evaluation was also performed through testing the generation of oxidative radicals, depletion of antioxidants via oxidative modification of lipids, proteins and DNA of organ cells. During the subchronic oral toxicity study, no mortality was observed, obvious treatment-related clinical signs and urinalysis parameters were in normal range. Differences in some hematological parameters, biochemistry, relative organ weight, and histopathology examinations between the treated group and the control group were not judged to be adverse. Our results indicated that the no-observed-adverse-effect level for xylanases was 1,500 TXU/kg/day and the plasma antioxidant assays showed that these xylanases did not produce free-radicals nor oxidative injuries. On the basis of the bacterial reverse mutation assay data, it is concluded that the expressed xylanase in Pichia pastoris do not present any mutagenic potential when tested in relevant genotoxicological assays. PMID:25044497

  10. Efficacy and safety of propofol sedation during urgent upper gastrointestinal endoscopy--a prospective study.

    PubMed

    Ljubicić, Neven; Supanc, Vladimir; Roić, Goran; Sharma, Mirella

    2003-06-01

    The aim of this study was to investigate both the efficacy and safety of sedation with propofol during urgent therapeutic gastroscopy in patients with upper gastrointestinal bleeding. This prospective study included a total of 110 patients. Propofol was administered intravenously at the starting dose of 1 mg/kg body weight and was followed by repeated doses. Oxygen saturation and heart rate were monitored by pulse oxymetry. The mean dose of propofol administered was 161 +/- 49 mg. Urgent upper GI endoscopy under propofol sedation was successful in 98% of cases. Endoscopists rated the sedation as good in 83.6%, satisfactory in 14.5%, and poor in 1.8% of patients. Potentially harmful drop in oxygen saturation below 85% was observed in 5.5% of patients, whereas a temporary drop in heart rate below 50 beats/min was observed in 11.8%, not requiring any intervention. Almost 93% of patients could not remember the beginning or the end of the intervention. This data demonstrates that sedation with propofol is suitable for use in patients with upper gastrointestinal bleeding undergoing urgent endoscopy. PMID:12974146

  11. Safety studies conducted on a proprietary high-purity aloe vera inner leaf fillet preparation, Qmatrix.

    PubMed

    Williams, Lonnie D; Burdock, George A; Shin, Eunju; Kim, Seunghyun; Jo, T H; Jones, Kenneth N; Matulka, Ray A

    2010-06-01

    The aloe vera plant has a long history of safe use for oral and topical applications. This publication describes safety studies conducted on a proprietary high-purity aloe vera inner leaf fillet preparation, Qmatrix. In a 13-week study in rats, Qmatrix was administered via gavage at 0, 500, 1000 and 2000 mg/kg body weight (bw)/day. There were no significant changes in food or water consumption, body weight, serum biochemistry or hematology at any of the doses tested. Sporadic, significant increases were observed in some of the measured urinalysis parameters; however, these variations were not treatment-related, as most were observed only in one sex, not dose-dependent and within historical control values. Organ weights were unaffected, except for a statistically significant, though not dose-dependent, increase in absolute and relative weights of the right kidney in males at 500 and 2000 mg/kg bw/day, respectively. Histopathological analysis revealed no abnormal signs. Qmatrix was non-mutagenic in an Ames test and a chromosomal aberration test at concentrations up to 10,000 microg/plate, and in an in vivo bone marrow micronucleus test at doses up to 5000 mg/kg bw/day. Based on these results, Qmatrix is not genotoxic in vitro or in vivo and; has an oral NOAEL greater than 2000 mg/kg bw/day following 90 days of oral exposure. PMID:20096744

  12. Radiation energy budget studies using collocated AVHRR and ERBE observations

    SciTech Connect

    Ackerman, S.A.; Inoue, Toshiro

    1994-03-01

    Changes in the energy balance at the top of the atmosphere are specified as a function of atmospheric and surface properties using observations from the Advanced Very High Resolution Radiometer (AVHRR) and the Earth Radiation Budget Experiment (ERBE) scanner. By collocating the observations from the two instruments, flown on NOAA-9, the authors take advantage of the remote-sensing capabilities of each instrument. The AVHRR spectral channels were selected based on regions that are strongly transparent to clear sky conditions and are therefore useful for characterizing both surface and cloud-top conditions. The ERBE instruments make broadband observations that are important for climate studies. The approach of collocating these observations in time and space is used to study the radiative energy budget of three geographic regions: oceanic, savanna, and desert. 25 refs., 8 figs.

  13. LMFBR conceptual design study: an overview of environmental and safety concerns

    SciTech Connect

    Brenchley, D.L.

    1981-06-01

    The US Department of Energy (DOE) initiated the Liquid Metal Fast Breeder (LMFBR) Conceptual Design Study (CDS) with the objective of maintaining a viable breeder option. The project is scheduled to be completed in FY-1981 but decisions regarding plant construction will be delayed until at least 1985. This report provides a review of the potential environmental and safety engineering concerns for the CDS and recommends specific action for the Environmental and Safety Engineering Division of DOE.

  14. Long Duration Head-Down Tilt Bed Rest Studies: Safety Considerations Regarding Vision Health

    NASA Technical Reports Server (NTRS)

    Cromwell, Ronita L.; Zanello, S. B.; Yarbough, P. O.; Ploutz-Snyder, Robert; Taibbi, G.; Vizzeri, G.

    2012-01-01

    Visual symptoms reported in astronauts returning from long duration missions in low Earth orbit, including hyperopic shift, choroidal folds, globe flattening and papilledema, are thought to be related to fluid shifts within the body due to microgravity exposure. Because of this possible relation to fluid shifts, safety considerations have been raised regarding the ocular health of head-down tilt (HDT) bed rest subjects. HDT is a widely used ground ]based analog that simulates physiological changes of spaceflight, including fluid shifts. Thus, vision monitoring has been performed in bed rest subjects in order to evaluate the safety of HDT with respect to vision health. Here we report ocular outcomes in 9 healthy subjects (age range: 27-48 years; Male/Female ratio: 8/1) completing bed rest Campaign 11, an integrated, multidisciplinary 70-day 6 degrees HDT bed rest study. Vision examinations were performed on a weekly basis, and consisted of office-based (2 pre- and 2 post-bed rest) and in-bed testing. The experimental design was a repeated measures design, with measurements for both eyes taken for each subject at each planned time point. Findings for the following tests were all reported as normal in each testing session for every subject: modified Amsler grid, red dot test, confrontational visual fields, color vision and fundus photography. Overall, no statistically significant differences were observed for any of the measures, except for both near and far visual acuity, which increased during the course of the study. This difference is not considered clinically relevant as may result from the effect of learning. Intraocular pressure results suggest a small increase at the beginning of the bed rest phase (p=0.059) and lesser increase at post-bed rest with respect to baseline (p=0.046). These preliminary results provide the basis for further analyses that will include correlations between intraocular pressure change pre- and post-bed rest, and optical coherence

  15. Evaluating the Impact of Database Heterogeneity on Observational Study Results

    PubMed Central

    Madigan, David; Ryan, Patrick B.; Schuemie, Martijn; Stang, Paul E.; Overhage, J. Marc; Hartzema, Abraham G.; Suchard, Marc A.; DuMouchel, William; Berlin, Jesse A.

    2013-01-01

    Clinical studies that use observational databases to evaluate the effects of medical products have become commonplace. Such studies begin by selecting a particular database, a decision that published papers invariably report but do not discuss. Studies of the same issue in different databases, however, can and do generate different results, sometimes with strikingly different clinical implications. In this paper, we systematically study heterogeneity among databases, holding other study methods constant, by exploring relative risk estimates for 53 drug-outcome pairs and 2 widely used study designs (cohort studies and self-controlled case series) across 10 observational databases. When holding the study design constant, our analysis shows that estimated relative risks range from a statistically significant decreased risk to a statistically significant increased risk in 11 of 53 (21%) of drug-outcome pairs that use a cohort design and 19 of 53 (36%) of drug-outcome pairs that use a self-controlled case series design. This exceeds the proportion of pairs that were consistent across databases in both direction and statistical significance, which was 9 of 53 (17%) for cohort studies and 5 of 53 (9%) for self-controlled case series. Our findings show that clinical studies that use observational databases can be sensitive to the choice of database. More attention is needed to consider how the choice of data source may be affecting results. PMID:23648805

  16. Safety of Excipients in Pediatric Formulations-A Call for Toxicity Studies in Juvenile Animals?

    PubMed

    Schmitt, Georg

    2015-01-01

    The development of drug products for pediatric use often requires age-appropriate formulations which can be more complex and may involve a broader range of excipients than adult dosage forms. Excipients established for adult use are not always appropriate for use in children because they can affect children differently than adults. Therefore, a comprehensive safety assessment of the excipients in a pediatric formulation is essential before use, referring to existing safety data from adult human and animals as well as safety data from pediatric use and juvenile toxicity studies, when available. The overall risk assessment needs to consider the safety risk from the excipients and the extent to which the risk from the disease as such will be ameliorated by the drug formulation. Non-clinical safety studies in juvenile animals are used to assess for specific toxicities or sensitivities of excipients and for establishing safe exposures in pediatric age groups. As for any active ingredient, non-clinical safety studies in juvenile animals should only be performed for excipients if important for clinical risk assessment and labelling. Pharmaceutical companies should be critical of excessive demands for juvenile animal testing, particularly of excipients when critically needed for significant therapeutic benefit. PMID:27417358

  17. Safety of Excipients in Pediatric Formulations—A Call for Toxicity Studies in Juvenile Animals?

    PubMed Central

    Schmitt, Georg

    2015-01-01

    The development of drug products for pediatric use often requires age-appropriate formulations which can be more complex and may involve a broader range of excipients than adult dosage forms. Excipients established for adult use are not always appropriate for use in children because they can affect children differently than adults. Therefore, a comprehensive safety assessment of the excipients in a pediatric formulation is essential before use, referring to existing safety data from adult human and animals as well as safety data from pediatric use and juvenile toxicity studies, when available. The overall risk assessment needs to consider the safety risk from the excipients and the extent to which the risk from the disease as such will be ameliorated by the drug formulation. Non-clinical safety studies in juvenile animals are used to assess for specific toxicities or sensitivities of excipients and for establishing safe exposures in pediatric age groups. As for any active ingredient, non-clinical safety studies in juvenile animals should only be performed for excipients if important for clinical risk assessment and labelling. Pharmaceutical companies should be critical of excessive demands for juvenile animal testing, particularly of excipients when critically needed for significant therapeutic benefit. PMID:27417358

  18. Studies of Accreting Neutron Stars with RXTE Cycle 4 Observations: III: TOO Observations of Atoll Sources

    NASA Technical Reports Server (NTRS)

    Paciesas, William S.

    2002-01-01

    NASA Grant NAG 5-9244 provided funds for the research projects 'ASM-Triggered TOO Observations of Kilohertz Oscillations in Five Atoll Sources' and 'Further Measurements of the Kilohertz Oscillations in 4U 1705-44' approved under the Rossi X-ray Timing Explorer (RXTE) Guest Observer Program Cycle 4 and funded under the 1999 NASA Astrophysics Data Program. The principal investigator of the observing time proposals was Dr. E. C. Ford (U. of Amsterdam). The grant was funded for one year beginning 3/15/2000. The original ADP proposal was submitted by Prof. Jan van Paradijs, who passed away in 1999 before the funds were distributed. Prof. Wilham S. Padesas administered the grant during the period of performance. In spite of a wealth of observational data on the kHz QPO in low-mass X-ray binaries (LMXBs), the interpretation of this phenomenon is currently uncertain because the pairs of kHz QPO peaks and the oscillations seen in some Type I X-ray bursts are almost, but not quite, connected by a simple beat frequency relation. Further systematic studies of systems with known QPOs are required in order to better understand the phenomenon. The proposals were intended to contribute to a solution to this confusion by observing the sources as they vary over a wide range of X-ray flux. RXTE target-of-opportunity observations of six transient atoll sources, 4U 0614+09, KS 1732-260, Ser X-1, 4U 1702-42, 4U 1820-30 and 4U 1705-44 were to be performed at various flux levels based on ASM measurements.

  19. 1985 NASA-Rockwell Space Station Crew Safety Study: results from Mir.

    PubMed

    Dudley-Rowley, M; Cohen, M M; Flores, P

    2004-01-01

    In 1985, Rockwell International (now Boeing--North American) completed the Space Station Crew Safety Alternatives Study for NASA. This five-volume study identified a wide range of potential safety threats and hazards that the crew might encounter on the future International Space Station. These threats included fire, explosion, collision, decompression, contamination, and radiation, among many others. One volume focused on the human factors aspects of safety, featuring the Crew Safety-Human Factors Interaction Model. In this model, a stressor (such as one of the threats) can lead to degraded performance, which can contribute to human error, unless appropriate and effective countermeasures are available to the crew. In 1986, the Soviet Union launched the Mir Space Station, the "second generation" that followed the Salyut series of space stations. The Mir was designed for a five-year life on orbit. It remained in use for fourteen years. During the first ten years, it performed well, with few safety issues. However, during the last four years, the aging station--operating at more than two times beyond its design lifetime--encountered a variety of safety hazards and human factors issues. Despite these often serious problems, the Mir crews always found a way to save the station, and no crew member was seriously injured or killed. This paper evaluates the safety record on Mir, and compares it to the NASA-Rockwell study, that was contemporaneous with the construction and launch of Mir. This comparison and analysis can provide a foundation for future space crew safety and related human factors support. PMID:15108594

  20. Work Domain Analysis for understanding medication safety in care homes in England: an exploratory study.

    PubMed

    Lim, Rosemary H M; Anderson, Janet E; Buckle, Peter W

    2016-01-01

    Medication safety and errors are a major concern in care homes. In addition to the identification of incidents, there is a need for a comprehensive system description to avoid the danger of introducing interventions that have unintended consequences and are therefore unsustainable. The aim of this study was to explore the impact and uniqueness of Work Domain Analysis (WDA) to facilitate an in-depth understanding of medication safety problems within the care home system and identify the potential benefits of WDA to design safety interventions to improve medication safety. A comprehensive, systematic and contextual overview of the care home medication system was developed for the first time. The novel use of the abstraction hierarchy (AH) to analyse medication errors revealed the value of the AH to guide a comprehensive analysis of errors and generate system improvement recommendations that took into account the contextual information of the wider system. PMID:26037621

  1. Burn Injury-Specific Home Safety Assessment: A Cross-Sectional Study in Iran

    PubMed Central

    Arshi, Shahnam; Bazargani, Homayoun Sadeghi; Mohammadi, Reza

    2012-01-01

    Background The aim of this study was to assess the feasibility of injury specific home safety investigation and to examine the home safety status focused on burn related safety in a rural population in the North-West of Iran. Methods A cross-sectional study was conducted on 265 rural households of rural Meshkinshahr, Iran. Cluster sampling method was used in 38 clusters with 7 households in each cluster. Clusters were selected on a probability proportional to size (PPS) basis using the available health census database called D-Tarh. Data were analyzed using the statistical software package STATA 8. Results Possible risks were explored in fields of house structure; cooking and eating attitudes and behaviors; cooking appliances, specific appliances such as picnic gas burners, valors (traditional heaters), samovars (traditional water boilers), and air-heating appliances. Many safety concerns were explored needing to draw the attention of researchers and public health policy makers. Conclusion Injury specific home safety surveys are useful and may provide useful information for safety promotion interventions. PMID:23209574

  2. Detailed Anatomy for the Transoral Approach to the Craniovertebral Junction: An Exposure and Safety Study

    PubMed Central

    Wang, Zhiyun; Xia, Hong; Wu, Zenghui; Ai, Fuzhi; Xu, Junjie; Yin, Qingshui

    2014-01-01

    Objective The aim of this study was to demonstrate the anatomical structures of the transoral approach to the craniovertebral junction. We evaluated the necessary exposure field and the safety of this approach. Methods Surgical operations with the transoral approach were performed on 36 cadaver specimens. The special anatomical structures were measured surrounding the exposure field with priorities given to measurements relating to the vertebral artery (VA). The anatomical relationships between the VA and nerves were observed. Results The exposure field partly covered the vertebral basilar system confluent. The middle clivus to upper C3 vertebral body can be exposed by transoral approach. Cranial nerves and cervical nerves emerged from the caudal of vertebrobasilar artery and circumambulated anterolaterally, and some abnormalities were observed in the intracranial segment of vertebrobasilar artery. The safe field was in an inverted trapezoid shape, of which the widest point was 25.5 ± 4.5 mm to the midline at C1 transverse process level; the narrowest point was 11.2 ± 1.5 mm to the midline at the C2–3 level. Conclusion Because the VA is the landmark of the safe field in this approach, surgeons should be very careful to avoid injuries of the VA and nerves while operating in the intracranial field or at the C2–3 level. PMID:24719800

  3. Observer Rated Sleepiness and Real Road Driving: An Explorative Study

    PubMed Central

    Anund, Anna; Fors, Carina; Hallvig, David; Åkerstedt, Torbjörn; Kecklund, Göran

    2013-01-01

    The aim of the present study was to explore if observer rated sleepiness (ORS) is a feasible method for quantification of driver sleepiness in field studies. Two measures of ORS were used: (1) one for behavioural signs based on facial expression, body gestures and body movements labelled B-ORS, and (2) one based on driving performance e.g. if swerving and other indicators of impaired driving occurs, labelled D-ORS. A limited number of observers sitting in the back of an experimental vehicle on a motorway about 2 hours repeatedly 3 times per day (before lunch, after lunch, at night) observed 24 participant’s sleepiness level with help of the two observer scales. At the same time the participant reported subjective sleepiness (KSS), EOG was recorded (for calculation of blink duration) and several driving measure were taken and synchronized with the reporting. Based on mixed model Anova and correlation analysis the result showed that observer ratings of sleepiness based on drivers’ impaired performance and behavioural signs are sensitive to extend the general pattern of time awake, circadian phase and time of driving. The detailed analysis of the subjective sleepiness and ORS showed weak correspondence on an individual level. Only 16% of the changes in KSS were predicted by the observer. The correlation between the observer ratings based on performance (D-ORS) and behavioural signs (B-ORS) are high (r = .588), and the B-ORS shows a moderately strong association (r = .360) with blink duration. Both ORS measures show an association (r>0.45) with KSS, whereas the association with driving performance is weak. The results show that the ORS-method detects the expected general variations in sleepy driving in field studies, however, sudden changes in driver sleepiness on a detailed level as 5 minutes is usually not detected; this holds true both when taking into account driving behaviour or driver behavioural signs. PMID:23724094

  4. Feasibility and safety study of a new device (Odón device) for assisted vaginal deliveries: study protocol

    PubMed Central

    2013-01-01

    Background Intrapartum complications are responsible for approximately half of all maternal deaths, and two million stillbirth and neonatal deaths per year. Prolonged second stage of labour is associated with potentially fatal maternal complications such as haemorrhage and infection and it is a major cause of stillbirth and newborn morbidity and mortality. Currently, the three main options for managing prolonged second stage of labour are forceps, vacuum extractor and caesarean section. All three clinical practices require relatively expensive equipment (e.g., a surgical theatre for caesarean section) and/or highly trained staff which are often not available in low resource settings. The specific aim of the proposed study is to test the safety and feasibility of a new device (Odón device) to effectively deliver the fetus during prolonged second stage of labour. The Odón device is a low-cost technological innovation to facilitate operative vaginal delivery and designed to minimize trauma to the mother and baby. These features combined make it a potentially revolutionary development in obstetrics, particularly for improving intrapartum care and reducing maternal and perinatal morbidity and mortality in low resource settings. Methods/design This will be a hospital-based, multicenter prospective phase 1 cohort study with no control group. Delivery with the Odón device will be attempted under normal labour and non-emergency conditions on all the women enrolled in the study. One-hundred and thirty pregnant women will be recruited in tertiary care facilities in Argentina. Safety will be assessed by examining maternal and infant outcomes until discharge. Feasibility will be evaluated by observing successful expulsion of the fetal head after one-time application of the device under standardized conditions (full cervical dilation, anterior presentation, +2 station, normal fetal heart rate). Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR

  5. Interstellar dust: interfacing laboratory, theoretical and observational studies

    NASA Astrophysics Data System (ADS)

    Jones, Anthony Peter

    2015-08-01

    In this talk I will consider how our understanding of interstellar dust can only be advanced through a combination of laboratory, theoretical and observational studies, which provide the critical framework for advancing our understanding. I will summarise what we currently know, or think we know, about the physical and compositional properties of dust and their evolution in interstellar media. Along the way I will question the utility of astronomical dust analogues and show, based on data from the laboratory, theoretical studies and from astronomical observations, that some of our prior interpretations need to be subjected to a critical re-evaluation. I will present interstellar dust modelling from a new vantage point and review ideas on the interpretation of observations within the framework of this model and its predictions for dust evolution within and between interstellar media. Finally, I will summarise some of the current outstanding issues and what we would like to learn in the future.

  6. Continuous Postoperative Pericardial Flushing: A Pilot Study on Safety, Feasibility, and Effect on Blood Loss

    PubMed Central

    Manshanden, Johan S.J.; Gielen, Chantal L.I.; de Borgie, Corianne A.J.M.; Klautz, Robert J.M.; de Mol, Bas A.J.M.; Koolbergen, David R.

    2015-01-01

    Background Prolonged or excessive blood loss is a common complication after cardiac surgery. Blood remnants and clots, remaining in the pericardial space in spite of chest tube drainage, induce high fibrinolytic activity that may contribute to bleeding complications. Continuous postoperative pericardial flushing (CPPF) with an irrigation solution may reduce blood loss by preventing the accumulation of clots. In this pilot study, the safety and feasibility of CPPF were evaluated and the effect on blood loss and other related complications was investigated. Methods Between November 2011 and April 2012 twenty-one adult patients undergoing surgery for congenital heart disease (CHD) received CPPF from sternal closure up to 12 h postoperative. With an inflow Redivac drain that was inserted through one of the chest tube incision holes, an irrigation solution (NaCl 0.9% at 38 °C) was delivered to the pericardial cavity using a volume controlled flushing system. Safety aspects, feasibility issues and complications were registered. The mean actual blood loss in the CPPF group was compared to the mean of a retrospective group (n = 126). Results CPPF was successfully completed in 20 (95.2%) patients, and no method related complications were observed. Feasibility was good in this experimental setting. Patients receiving CPPF showed a 30% (P = 0.038) decrease in mean actual blood loss 12 h postoperatively. Conclusions CPPF after cardiac surgery was found to be safe and feasible in this experimental setting. The clinically relevant effect on blood loss needs to be confirmed in a randomized clinical trial. PMID:26501121

  7. Efficacy and safety of azithromycin for uncomplicated typhoid fever: an open label non-comparative study.

    PubMed

    Aggarwal, Anju; Ghosh, Apurba; Gomber, Sunil; Mitra, Monjori; Parikh, A O

    2011-07-01

    An open-labelled, non-comparative study was conducted in 117 children aged 2-12 years to evaluate the efficacy and safety of azithromycin (20mg/ kg/day for 6 days) for the treatment of uncomplicated typhoid fever. Of the patients enrolled based on a clinical definition of typhoid fever, 109 (93.1%) completed the study.Mean (SD) of duration of fever at presentation was 9.1(4.5) days. Clinical cure was seen in 102 (93.5%) subjects, while 7 were withdrawn from the study because of clinical deterioration. Mean day of response was 3.45±1.97. BACTEC blood culture was positive for Salmonella typhi in 17/109 (15.5%) and all achieved bacteriological cure. No serious adverse event was observed. Global well being assessed by the investigator and subjects was good in 95% cases which was done at the end of the treatment. Azithromycin was found to be safe and efficacious for the management of uncomplicated typhoid fever. PMID:21555791

  8. The Indiana Science Initiative: Lessons from a Classroom Observation Study

    ERIC Educational Resources Information Center

    Cook, Nicole D.; Walker, William S.; Weaver, Gabriela C.; Sorge, Brandon H.

    2015-01-01

    The Indiana Science Initiative (ISI) is a systemic effort to reform K-8 science education. The program provides teachers with professional development, reform-oriented science modules, and materials support. To examine the impact of the initiative's professional development, a participant observation study was conducted in the program's pilot…

  9. Scientific and Ethical Approaches for Observational Exposure Studies

    EPA Science Inventory

    Researchers conduct observational human exposure studies to understand how and the extent to which people come into contact with chemicals and environmental stressors in their everyday lives, through the air they breathe, the food and liquids they consume, and the things they tou...

  10. Space observations for global and regional studies of the biosphere

    NASA Technical Reports Server (NTRS)

    Cihlar, J.; Li, Z.; Chen, J.; Sellers, P.; Hall, F.

    1994-01-01

    The capability to make space-based measurements of Earth at high spatial and temporal resolutions, which would not otherwise be economically or practically feasible, became available just in time to contribute to scientific understanding of the interactive processes governing the total Earth system. Such understanding has now become essential in order to take practical steps which would counteract or mitigate the pervasive impact of the growing human population on the future habitability of the Earth. The paper reviews the rationale for using space observations for studies of climate and terrestrial ecosystems at global and regional scales, as well as the requirements for such observations for studies of climate and ecosystem dynamics. The present status of these developments is reported along with initiatives under way to advance the use of satellite observations for Earth system studies. The most important contribution of space observations is the provision of physical or biophysical parameters for models representing various components of the Earth system. Examples of such parameters are given for climatic and ecosystem studies.

  11. Observational Studies of Retarded Children with Multiple Stereotyped Movements.

    ERIC Educational Resources Information Center

    Baumeister, Alfred A.; And Others

    1980-01-01

    Three relatively long-term observational studies, involving seven retarded preschool children, each of whom exhibited multiple stereotypes, were conducted to determine the extent to which the type of activity or setting had any effect upon the rates of stereotyped movements. (Author)

  12. Studies of the observed and theoretical variations of atmospheric ozone

    NASA Technical Reports Server (NTRS)

    London, Julius

    1990-01-01

    The four related topics covered include: (1) distributions of total and upper atmospheric ozone and their time and space variations; (2) observed and theoretical models of the quasi-biennial oscillation (QBO) ozone variation; (3) radiative processes in the upper atmosphere; and (4) relations between ozone and solar variations. The results of these studies are presented. They come from twenty-three published papers.

  13. Efficacy and Safety of Liposomal Amphotericin B for the Treatment of Mucosal Leishmaniasis from the New World: A Retrospective Study.

    PubMed

    Cunha, Mirella A; Leão, Aline C Q; de Cassia Soler, Rita; Lindoso, José Angelo L

    2015-12-01

    The standard treatment of mucosal leishmaniasis (ML) is pentavalent antimonials, agents with serious adverse effects. Alternative agents include amphotericin B deoxycholate and liposomal amphotericin B. We performed a retrospective study including 29 patients treated with liposomal amphotericin B, most of whom had comorbidities, history of previous treatment of ML, and contraindications to the use of antimonial pentavalent or amphotericin B deoxycholate. We observed a cure rate of 93.1%. Kidney failure was the most important side effect, reported in five patients (17.2%). This study showed a good efficacy and safety profile of liposomal amphotericin B in patients with ML and contraindications to the use of other agents. PMID:26483120

  14. Intervention effects on safety compliance and citizenship behaviors: Evidence from the Work, Family, and Health Study.

    PubMed

    Hammer, Leslie B; Johnson, Ryan C; Crain, Tori L; Bodner, Todd; Kossek, Ellen Ernst; Davis, Kelly D; Kelly, Erin L; Buxton, Orfeu M; Karuntzos, Georgia; Chosewood, L Casey; Berkman, Lisa

    2016-02-01

    We tested the effects of a work-family intervention on employee reports of safety compliance and organizational citizenship behaviors in 30 health care facilities using a group-randomized trial. Based on conservation of resources theory and the work-home resources model, we hypothesized that implementing a work-family intervention aimed at increasing contextual resources via supervisor support for work and family, and employee control over work time, would lead to improved personal resources and increased employee performance on the job in the form of self-reported safety compliance and organizational citizenship behaviors. Multilevel analyses used survey data from 1,524 employees at baseline and at 6-month and 12-month postintervention follow-ups. Significant intervention effects were observed for safety compliance at the 6-month, and organizational citizenship behaviors at the 12-month, follow-ups. More specifically, results demonstrate that the intervention protected against declines in employee self-reported safety compliance and organizational citizenship behaviors compared with employees in the control facilities. The hypothesized mediators of perceptions of family-supportive supervisor behaviors, control over work time, and work-family conflict (work-to-family conflict, family-to-work conflict) were not significantly improved by the intervention. However, baseline perceptions of family-supportive supervisor behaviors, control over work time, and work-family climate were significant moderators of the intervention effect on the self-reported safety compliance and organizational citizenship behavior outcomes. PMID:26348479

  15. Observer study to evaluate the simulation of mammographic calcification clusters

    NASA Astrophysics Data System (ADS)

    Sousa, Maria A. Z.; Marcomini, Karem D.; Bakic, Predrag R.; Maidment, Andrew D. A.; Schiabel, Homero

    2016-03-01

    Numerous breast phantoms have been developed to be as realistic as possible to ensure the accuracy of image quality analysis, covering a greater range of applications. In this study, we simulated three different densities of the breast parenchyma using paraffin gel, acrylic plates and PVC films. Hydroxyapatite was used to simulate calcification clusters. From the images acquired with a GE Senographe DR 2000D mammography system, we selected 68 regions of interest (ROIs) with and 68 without a simulated calcification cluster. To validate the phantom simulation, we selected 136 ROIs from the University of South Florida's Digital Database for Screening Mammography (DDSM). Seven trained observers performed two observer experiments by using a high-resolution monitor Barco mod. E-3620. In the first experiment, the observers had to distinguish between real or phantom ROIs (with and without calcification). In the second one, the observers had to indicate the ROI with calcifications between a pair of ROIs. Results from our study show that the hydroxyapatite calcifications had poor contrast in the simulated breast parenchyma, thus observers had more difficulty in identifying the presence of calcification clusters in phantom images. Preliminary analysis of the power spectrum was conducted to investigate the radiographic density and the contrast thresholds for calcification detection. The values obtained for the power spectrum exponent (β) were comparable with those found in the literature.

  16. Visual perception studies and observer models in medical imaging.

    PubMed

    Burgess, Arthur E

    2011-11-01

    Most academic radiologists will be familiar with receiver operating characteristic (ROC) studies. Fundamental studies of human observer performance are now usually performed by forced-choice methods. Both methods are based on signal detection theory. The ROC method gives an operating curve of true-positive versus false-positive probabilities. The area under the curve, A(Z), can be used a summary performance measure. In the forced-choice method, observers are given 2 or more images with one containing the signal. The observer's task is to select the option most likely to contain the signal. The percentage of correct responses, PC, is a summary performance measure. Precise comparison of the 2 methods is limited to very controlled experiments in which signals (simulated lesions for example) are carefully designed and detection or discrimination is limited by true random noise. Under these conditions, theory predicts a simple relationship between summary measures and human results are consistent with theory. There will be a description of forced-choice experimental methods and data analysis. There has also been considerable work on development of theoretic observer models. Human experiment results have used to evaluate the models. Models that correlate well with human performance in turn can be used for preliminary design of new imaging systems and for selection of image quality metrics for comparing equipment performance, this article will provide a summary of work during the last 30 years on evaluating human signal detection capabilities, observer models and image quality metrics. PMID:21978445

  17. The role of observational studies in optimizing the clinical management of chronic myeloid leukemia

    PubMed Central

    Davis, Catherine; Zyczynski, Teresa; Khoury, H. Jean

    2015-01-01

    Survival has increased dramatically for patients with chronic phase chronic myeloid leukemia (CP-CML) using BCR-ABL targeted tyrosine kinase inhibitors, such that life expectancy is expected to approximate that of patients without CP-CML. Randomized controlled trials (RCTs) and observational studies provide valuable insights into the management of chronic diseases such as CP-CML. RCTs are undoubtedly the backbone of clinical research, and the ‘gold standard’ for evaluating the efficacy and safety of new therapies. However, many questions surrounding the optimal management of patients with CML remain unanswered, and it is widely accepted that these questions will be best answered by evaluating the use of available therapies in clinical practice. Observational studies can extend the knowledge base beyond the clinical trial setting and thus capture a more accurate picture of everyday clinical practice, particularly patients’ experiences of long-term CML treatment. There is therefore growing interest in and appreciation of the value of observational research. This review article will examine the relative merits of RCTs and observational studies in the setting of CML, highlighting those factors – such as the advancing age of the CML patient population and growing importance of patient-reported outcomes – that mean that observational studies should play an important role in shaping clinical practice. This article also provides an overview of what observational studies have told us thus far about the optimal management of patients with CML, outlines some of the key remaining unanswered clinical questions in CML, and summarizes ongoing observational studies designed to provide answers to these key questions. PMID:25642311

  18. Non-Clinical Safety Studies of IMT504, a Unique Non-CpG Oligonucleotide

    PubMed Central

    Franco, Raúl; Rodriguez, Juan M.; Elías, Fernanda; Hernando-Insúa, Andrés; Fló, Juan; López, Ricardo; Nagle, Carlos; Lago, Néstor; Zorzopulos, Jorge; Horn, David L.

    2014-01-01

    IMT504 is a non-CpG 24-mer oligodeoxynucleotide (ODN) with immunomodulatory as well as tissue repair activity. IMT504 has been previously proven to be effective in animal models of vaccine potency, chronic lymphocytic leukemia, tissue regeneration, and sepsis. Here, we assessed the safety, including pharmacokinetics and toxicity studies in rats and monkeys, of IMT504 in a single- or repeated-dose administration by the subcutaneous (SC) or intravenous (IV) routes. In rats, the maximum tolerated dose was determined to be 50 mg/kg when administered SC. Adverse effects at 50 mg/kg were mild and reversible liver injury, revealed as lobular inflammation, focal necrosis, and small changes in the transaminase profile. Dose-dependent splenomegaly and lymphoid hyperplasia, most probably associated with immune stimulation, were commonly observed. Rats and monkeys were also IV injected with a single dose of 10 or 3.5 mg/kg, and no adverse effects were observed. Rats injected IV with 10 mg/kg showed a transient increase in spleen weight, together with a slight increase in the marginal zone of the white pulp and in leukocyte count 2 days post-administration. In monkeys, this dosage caused slight changes in total serum complement and leukocyte count on day 14. No adverse effects were observed at 3.5 mg/kg IV in rats or monkeys. Therefore, this dose was defined as the “no observed adverse effect level” for this route. Furthermore, repeated-dose toxicity studies were performed in these species using 3.5 or 0.35 mg/kg/day IV for 6 weeks. A transient increase in the spleen and liver weight was observed at 3.5 mg/kg/day only in female rats. No changes in clotting time and activation of the alternative complement pathway were observed. The toxicity profile of IMT504 herein reported suggests a dose range in which IMT504 can be used safely in clinical trials. PMID:24720569

  19. Safety of influenza vaccination during pregnancy: a review of subsequent maternal obstetric events and findings from two recent cohort studies.

    PubMed

    Naleway, Allison L; Irving, Stephanie A; Henninger, Michelle L; Li, De-Kun; Shifflett, Pat; Ball, Sarah; Williams, Jennifer L; Cragan, Janet; Gee, Julianne; Thompson, Mark G

    2014-05-30

    Pregnant women and their infants are vulnerable to severe disease and secondary complications from influenza infection. For this reason, annual influenza vaccination is recommended for all pregnant women in the United States. Women frequently cite concerns about vaccine safety as a barrier to vaccination. This review describes the safety of inactivated influenza vaccination during pregnancy with a focus on maternal obstetric events, including hypertensive disorders, gestational diabetes, and chorioamnionitis. Included in the review are new findings from two studies which examined the safety of seasonal inactivated influenza vaccination during pregnancy. The first study enrolled 641 pregnant women during the 2010-2011 season and prospectively followed them until delivery or pregnancy termination. The second study enrolled 1616 pregnant women during the 2010-2011 influenza season, and followed the women and their infants for six months after delivery. No associations between inactivated influenza vaccination and gestational diabetes, gestational hypertension, preeclampsia/eclampsia, or chorioamnionitis were observed in either cohort. When considered as a whole, these studies should further reassure women and clinicians that influenza vaccination during pregnancy is safe for mothers. PMID:24742490

  20. Can Health Visitor Intervention Change Sun Safety Policies and Practice in Preschool Establishments? A Randomised Controlled Study

    ERIC Educational Resources Information Center

    Syson-Nibbs, Linda; Peters, Jean; Saul, Carol

    2005-01-01

    Objective: In the UK there have been no initiatives identified to increase the use of sun safety policies in preschool establishments. This study tests the hypothesis that health visitors with appropriate sun safety training can successfully facilitate the development and implementation of sun safety policies and practices in preschool education…

  1. Understanding parental motivators and barriers to uptake of child poison safety strategies: a qualitative study

    PubMed Central

    Gibbs, L; Waters, E; Sherrard, J; Ozanne-Smith, J; Robinson, J; Young, S; Hutchinson, A

    2005-01-01

    Objectives: To develop an understanding of factors acting as barriers and motivators to parental uptake of child poison safety strategies. Design: A qualitative study involving semistructured interviews and focus groups. A grounded theory approach was used for the collection and analysis of data. Participants: Sixty five parents of children under 5 years of age, some of whom had experienced an unintentional child poisoning incident. Results: A range of knowledge based, environmental, and behavioral barriers to comprehensive parental uptake of poison safety practices were identified. As a result there tended to be only partial implementation of safety initiatives in the home. Selection of safety practices was often guided by the interests and behaviors of the child. This made the child vulnerable to changes in the home environment, inadequate supervision, and/or shifts in their own behavior and developmental ability. Personal or vicarious exposure of a parent to a child poisoning incident was a significant motivator for parental review of safety practices. Conclusion: Environmental measures targeting child resistant containers, warning labels, and lockable poisons cupboards will support parents' efforts to maintain poison safety. Additional education campaigns using stories of actual poisoning incidents may help to increase awareness of risk and encourage increased uptake. PMID:16326774

  2. Medication safety in community pharmacy: a qualitative study of the sociotechnical context

    PubMed Central

    Phipps, Denham L; Noyce, Peter R; Parker, Dianne; Ashcroft, Darren M

    2009-01-01

    Background While much research has been conducted on medication safety, few of these studies have addressed primary care, despite the high volume of prescribing and dispensing of medicines that occurs in this setting. Those studies that have examined primary care dispensing emphasised the need to understand the role of sociotechnical factors (that is, the interactions between people, tasks, equipment and organisational structures) in promoting or preventing medication incidents. The aim of this study was to identify sociotechnical factors that community pharmacy staff encounter in practice, and suggest how these factors might impact on medication safety. Methods Sixty-seven practitioners, working in the North West of England, took part in ten focus groups on risk management in community pharmacy. The data obtained from these groups was subjected to a qualitative analysis to identify recurrent themes pertaining to sociotechnical aspects of medication safety. Results The findings indicated several characteristics of participants' work settings that were potentially related to medication safety. These were broadly classified as relationships involving the pharmacist, demands on the pharmacist and management and governance of pharmacists. Conclusion It is recommended that the issues raised in this study be considered in future work examining medication safety in primary care. PMID:19735550

  3. Three Reflections on Assessing Safety Training Needs: A Case Study

    ERIC Educational Resources Information Center

    Sleezer, Catherine M.; Kelsey, Kathleen D.; Wood, Thomas E.

    2008-01-01

    Needs assessment plays an important role in training and human performance improvement efforts, but the literature contains little research on this topic. This study extended previous research on the Performance Analysis for Training (PAT) model of needs assessment by examining its implementation to determine environmental and occupational health…

  4. Adverse inpatient outcomes during the transition to a new electronic health record system: observational study

    PubMed Central

    Barnett, Michael L; Mehrotra, Ateev

    2016-01-01

    Objective To assess the short term association of inpatient implementation of electronic health records (EHRs) with patient outcomes of mortality, readmissions, and adverse safety events. Design Observational study with difference-in-differences analysis. Setting Medicare, 2011-12. Participants Patients admitted to 17 study hospitals with a verifiable “go live” date for implementation of inpatient EHRs during 2011-12, and 399 control hospitals in the same hospital referral region. Main outcome measures All cause readmission within 30 days of discharge, all cause mortality within 30 days of admission, and adverse safety events as defined by the patient safety for selected indicators (PSI)-90 composite measure among Medicare beneficiaries admitted to one of these hospitals 90 days before and 90 days after implementation of the EHRs (n=28 235 and 26 453 admissions), compared with the control group of all contemporaneous admissions to hospitals in the same hospital referral region (n=284 632 and 276 513 admissions). Analyses were adjusted for beneficiaries’ sociodemographic and clinical characteristics. Results Before and after implementation, characteristics of admissions were similar in both study and control hospitals. Among study hospitals, unadjusted 30 day mortality (6.74% to 7.15%, P=0.06) and adverse safety event rates (10.5 to 11.4 events per 1000 admissions, P=0.34) did not significantly change after implementation of EHRs. There was an unadjusted decrease in 30 day readmission rates, from 19.9% to 19.0% post-implementation (P=0.02). In difference-in-differences analysis, however, there was no significant change in any outcome between pre-implementation and post-implementation periods (all P≥0.13). Conclusions Despite concerns that implementation of EHRs might adversely impact patient care during the acute transition period, we found no overall negative association of such implementation on short term inpatient mortality, adverse safety

  5. Development of a software safety process and a case study of its use

    NASA Technical Reports Server (NTRS)

    Knight, John C.

    1993-01-01

    The goal of this research is to continue the development of a comprehensive approach to software safety and to evaluate the approach with a case study. The case study is a major part of the project, and it involves the analysis of a specific safety-critical system from the medical equipment domain. The particular application being used was selected because of the availability of a suitable candidate system. We consider the results to be generally applicable and in no way particularly limited by the domain. The research is concentrating on issues raised by the specification and verification phases of the software lifecycle since they are central to our previously-developed rigorous definitions of software safety. The theoretical research is based on our framework of definitions for software safety. In the area of specification, the main topics being investigated are the development of techniques for building system fault trees that correctly incorporate software issues and the development of rigorous techniques for the preparation of software safety specifications. The research results are documented. Another area of theoretical investigation is the development of verification methods tailored to the characteristics of safety requirements. Verification of the correct implementation of the safety specification is central to the goal of establishing safe software. The empirical component of this research is focusing on a case study in order to provide detailed characterizations of the issues as they appear in practice, and to provide a testbed for the evaluation of various existing and new theoretical results, tools, and techniques. The Magnetic Stereotaxis System is summarized.

  6. Application of population pharmacokinetics for preclinical safety and efficacy studies.

    PubMed

    Porzio, Stefano

    2013-08-01

    From the beginning of the 1980s, population PK has been primarily used in clinical development and only in the last decade has it been convincingly applied in a preclinical setting. Sparse sampling and covariate analyses are key features of preclinical popPK, useful for toxicology and efficacy studies in animals to assemble data obtained from different studies; for describing individual PK and PD; for building mechanistic models; and for performing interspecies scaling-up of disposition and efficacy. Application in disease models, mainly in behavioral and neurological models, allows the quantitative description of PK and PD without frequent blood sampling and recurrent physiological measurements, which are the critical and compromising perturbations of experimental systems. A preclinical population approach to PK and PD, by its versatility and possibility of simulating 'what if' scenarios, offers a unique and potent tool in the development of new drugs, in particular biologics. PMID:23937139

  7. Improving Aviation Safety with information Visualization: A Flight Simulation Study

    NASA Technical Reports Server (NTRS)

    Aragon, Cecilia R.; Hearst, Marti

    2005-01-01

    Many aircraft accidents each year are caused by encounters with invisible airflow hazards. Recent advances in aviation sensor technology offer the potential for aircraft-based sensors that can gather large amounts of airflow velocity data in real-time. With this influx of data comes the need to study how best to present it to the pilot - a cognitively overloaded user focused on a primary task other than that of information visualization. In this paper, we present the results of a usability study of an airflow hazard visualization system that significantly reduced the crash rate among experienced helicopter pilots flying a high fidelity, aerodynamically realistic fixed-base rotorcraft flight simulator into hazardous conditions. We focus on one particular aviation application, but the results may be relevant to user interfaces in other operationally stressful environments.

  8. Aspartame: a safety evaluation based on current use levels, regulations, and toxicological and epidemiological studies.

    PubMed

    Magnuson, B A; Burdock, G A; Doull, J; Kroes, R M; Marsh, G M; Pariza, M W; Spencer, P S; Waddell, W J; Walker, R; Williams, G M

    2007-01-01

    Aspartame is a methyl ester of a dipeptide used as a synthetic nonnutritive sweetener in over 90 countries worldwide in over 6000 products. The purpose of this investigation was to review the scientific literature on the absorption and metabolism, the current consumption levels worldwide, the toxicology, and recent epidemiological studies on aspartame. Current use levels of aspartame, even by high users in special subgroups, remains well below the U.S. Food and Drug Administration and European Food Safety Authority established acceptable daily intake levels of 50 and 40 mg/kg bw/day, respectively. Consumption of large doses of aspartame in a single bolus dose will have an effect on some biochemical parameters, including plasma amino acid levels and brain neurotransmitter levels. The rise in plasma levels of phenylalanine and aspartic acid following administration of aspartame at doses less than or equal to 50 mg/kg bw do not exceed those observed postprandially. Acute, subacute and chronic toxicity studies with aspartame, and its decomposition products, conducted in mice, rats, hamsters and dogs have consistently found no adverse effect of aspartame with doses up to at least 4000 mg/kg bw/day. Critical review of all carcinogenicity studies conducted on aspartame found no credible evidence that aspartame is carcinogenic. The data from the extensive investigations into the possibility of neurotoxic effects of aspartame, in general, do not support the hypothesis that aspartame in the human diet will affect nervous system function, learning or behavior. Epidemiological studies on aspartame include several case-control studies and one well-conducted prospective epidemiological study with a large cohort, in which the consumption of aspartame was measured. The studies provide no evidence to support an association between aspartame and cancer in any tissue. The weight of existing evidence is that aspartame is safe at current levels of consumption as a nonnutritive

  9. Testing VHF/GPS Collar Design and Safety in the Study of Free-Roaming Horses

    PubMed Central

    Collins, Gail H.; Petersen, Steven L.; Carr, Craig A.; Pielstick, Leon

    2014-01-01

    Effective and safe monitoring techniques are needed by U.S. land managers to understand free-roaming horse behavior and habitat use and to aid in making informed management decisions. Global positioning system (GPS) and very high frequency (VHF) radio collars can be used to provide high spatial and temporal resolution information for detecting free-roaming horse movement. GPS and VHF collars are a common tool used in wildlife management, but have rarely been used for free-roaming horse research and monitoring in the United States. The purpose of this study was to evaluate the design, safety, and detachment device on GPS/VHF collars used to collect free-roaming horse location and movement data. Between 2009 and 2010, 28 domestic and feral horses were marked with commercial and custom designed VHF/GPS collars. Individual horses were evaluated for damage caused by the collar placement, and following initial observations, collar design was modified to reduce the potential for injury. After collar modifications, which included the addition of collar length adjustments to both sides of the collar allowing for better alignment of collar and neck shapes, adding foam padding to the custom collars to replicate the commercial collar foam padding, and repositioning the detachment device to reduce wear along the jowl, we observed little to no evidence of collar wear on horses. Neither custom-built nor commercial collars caused injury to study horses, however, most of the custom-built collars failed to collect data. During the evaluation of collar detachment devices, we had an 89% success rate of collar devices detaching correctly. This study showed that free-roaming horses can be safely marked with GPS and/or VHF collars with minimal risk of injury, and that these collars can be a useful tool for monitoring horses without creating a risk to horse health and wellness. PMID:25198704

  10. Carbon Dioxide Observational Platform System (CO-OPS), feasibility study

    NASA Technical Reports Server (NTRS)

    Bouquet, D. L.; Hall, D. W.; Mcelveen, R. P.

    1987-01-01

    The Carbon Dioxide Observational Platform System (CO-OPS) is a near-space, geostationary, multi-user, unmanned microwave powered monitoring platform system. This systems engineering feasibility study addressed identified existing requirements such as: carbon dioxide observational data requirements, communications requirements, and eye-in-the-sky requirements of other groups like the Defense Department, the Forestry Service, and the Coast Guard. In addition, potential applications in: earth system science, space system sciences, and test and verification (satellite sensors and data management techniques) were considered. The eleven month effort is summarized. Past work and methods of gathering the required observational data were assessed and rough-order-of magnitude cost estimates have shown the CO-OPS system to be most cost effective (less than $30 million within a 10 year lifetime). It was also concluded that there are no technical, schedule, or obstacles that would prevent achieving the objectives of the total 5-year CO-OPS program.

  11. SHPPS 2006: School Health Policies and Programs Study--Food Safety

    ERIC Educational Resources Information Center

    Centers for Disease Control and Prevention, 2007

    2007-01-01

    The School Health Policies and Programs Study (SHPPS) is a national survey periodically conducted to assess school health policies and programs at the state, district, school, and classroom levels. This brief reports study results in the area of food safety, covering the following topics: (1) Health Education; (2) Health Services; and (3)…

  12. Fundamental ignition study for material fire safety improvement, part 1

    NASA Technical Reports Server (NTRS)

    Paciorek, K. L.; Zung, L. B.

    1970-01-01

    The investigation of preignition, ignition, and combustion characteristics of Delrin (acetate terminated polyformaldehyde) and Teflon (polytetrafluoroethylene) resins in air and oxygen are presented. The determination of ignition limits and their dependence on temperature and the oxidizing media, as well as the analyses of the volatiles produced, were studied. Tests were conducted in argon, an inert medium in which only purely pyrolytic reactions can take place, using the stagnation burner arrangement designed and constructed for this purpose. A theoretical treatment of the ignition and combination phenomena was devised. In the case of Delrin the ignition and ignition delays are apparently independent of the gas (air, oxygen) temperatures. The results indicate that hydrogen is the ignition triggering agent. Teflon ignition limits were established in oxygen only.

  13. Patient safety priorities in mental healthcare in Switzerland: a modified Delphi study

    PubMed Central

    Mascherek, Anna C

    2016-01-01

    Objective Identifying patient safety priorities in mental healthcare is an emerging issue. A variety of aspects of patient safety in medical care apply for patient safety in mental care as well. However, specific aspects may be different as a consequence of special characteristics of patients, setting and treatment. The aim of the present study was to combine knowledge from the field and research and bundle existing initiatives and projects to define patient safety priorities in mental healthcare in Switzerland. The present study draws on national expert panels, namely, round-table discussion and modified Delphi consensus method. Design As preparation for the modified Delphi questionnaire, two round-table discussions and one semistructured questionnaire were conducted. Preparative work was conducted between May 2015 and October 2015. The modified Delphi was conducted to gauge experts' opinion on priorities in patient safety in mental healthcare in Switzerland. In two independent rating rounds, experts made private ratings. The modified Delphi was conducted in winter 2015. Results Nine topics were defined along the treatment pathway: diagnostic errors, non-drug treatment errors, medication errors, errors related to coercive measures, errors related to aggression management against self and others, errors in treatment of suicidal patients, communication errors, errors at interfaces of care and structural errors. Conclusions Patient safety is considered as an important topic of quality in mental healthcare among experts, but it has been seriously neglected up until now. Activities in research and in practice are needed. Structural errors and diagnostics were given highest priority. From the topics identified, some are overlapping with important aspects of patient safety in medical care; however, some core aspects are unique. PMID:27496233

  14. The Effect of a Freely Available Flipped Classroom Course on Health Care Worker Patient Safety Culture: A Prospective Controlled Study

    PubMed Central

    Ling, Lowell; Gomersall, Charles David; Samy, Winnie; Joynt, Gavin Matthew; Leung, Czarina CH; Wong, Wai-Tat

    2016-01-01

    Background Patient safety culture is an integral aspect of good standard of care. A good patient safety culture is believed to be a prerequisite for safe medical care. However, there is little evidence on whether general education can enhance patient safety culture. Objective Our aim was to assess the impact of a standardized patient safety course on health care worker patient safety culture. Methods Health care workers from Intensive Care Units (ICU) at two hospitals (A and B) in Hong Kong were recruited to compare the changes in safety culture before and after a patient safety course. The BASIC Patient Safety course was administered only to staff from Hospital A ICU. Safety culture was assessed in both units at two time points, one before and one after the course, by using the Hospital Survey on Patient Safety Culture questionnaire. Responses were coded according to the Survey User’s Guide, and positive response percentages for each patient safety domain were compared to the 2012 Agency for Healthcare Research and Quality ICU sample of 36,120 respondents. Results We distributed 127 questionnaires across the two hospitals with an overall response rate of 74.8% (95 respondents). After the safety course, ICU A significantly improved on teamwork within hospital units (P=.008) and hospital management support for patient safety (P<.001), but decreased in the frequency of reporting mistakes compared to the initial survey (P=.006). Overall, ICU A staff showed significantly greater enhancement in positive responses in five domains than staff from ICU B. Pooled data indicated that patient safety culture was poorer in the two ICUs than the average ICU in the Agency for Healthcare Research and Quality database, both overall and in every individual domain except hospital management support for patient safety and hospital handoffs and transitions. Conclusions Our study demonstrates that a structured, reproducible short course on patient safety may be associated with an

  15. Evaluation Series on Safety and Efficacy of Nutritional Supplements in Newly Diagnosed Hyperglycemia: A Placebo-Controlled, Randomized Study

    PubMed Central

    Thacker, Hemant; Bantwal, Ganapati; Jain, Sunil; Kalra, Sanjay; Kale, Shailaja; Saboo, Banshi; Gupta, Jugal B.; Sivam, Sakthivel

    2016-01-01

    Background: Diabetes is endemic with developing economies contributing to the bulk of this pandemic. Despite the evidence of incremental benefit of glycemic control starting early in life, acceptance of and adherence to modern medications remain suboptimal. Aims: To determine the hemoglobin A1c (HbA1c)-lowering efficacy and safety of nutritional supplement, PreCrea®, in adult Indians with newly diagnosed hyperglycemia. Materials and Methods: Double-blind, randomized study conducted in six diabetes centers in India. A total of 193 treatment-naïve subjects with newly diagnosed hyperglycemia and fasting plasma glucose (FPG) >100 mg/dL were randomized into either PreCrea® 600 mg (n = 90) or matched placebo (n = 89) capsules twice daily, along with lifestyle modification, for 12 weeks. The main outcomes were changes in HbA1c and FPG levels, attainment of the American Diabetes Association (ADA)-defined goals for HbA1c, and clinical and biochemical measures of safety. Results: At 12 weeks, mean HbA1c in PreCrea® group reduced by 0.91% compared with 0.08% increase in the placebo group (P < .001). The reductions in the mean FPG at week 4 (P < .001) and week 12 (P = 0.04) were significant compared to the baseline. ADA goal of HbA1c <7% increased from 15.5% at the baseline to 35.6% at week 12 in PreCrea® subjects. Clinical safety and biochemical safety did not change. Hypoglycemia and weight gain were not observed with PreCrea®. Conclusions: Nearly 1% point reduction in HbA1c at week 12 with PreCrea® is comparable with most first-line glucose-lowering drugs. The safety and tolerability of PreCrea® highlights its potential as a first-line therapy in newly detected hyperglycemia. PMID:27042609

  16. Foreshock structures observed by THEMIS: case and statistical studies

    NASA Astrophysics Data System (ADS)

    Urbar, Jaroslav; Jelinek, Karel; Nemecek, Zdenek; Safrankova, Jana; Prech, Lubomir

    The ion foreshock region is typically observed upstream of the Earth’s quasi-parallel bow shocks and is characterized by enhanced ULF waves. These waves are created due to the interaction of the solar wind plasma with the ions reflected at the bow shock. As a result, fast magnetosonic waves are generated with an in-phase relationship between ion flux and magnetic field fluctuations. Using multipoint observations upstream of Earth’s bow shock from the Themis mission, we present statistical maps of modification of upstream parameters due to foreshock processes (solar wind heating and deceleration, enhancements of the magnetic field fluctuation level, etc.). The statistical study is complemented with case studies of transient phenomena in the foreshock like foreshock bubbles, hot flow anomalies, and others. We investigate an influence of foreshock effects on the bow shock and magnetopause motions and discuss a role of energetic particles and magnetic field orientations in these processes.

  17. Driving behaviours, traffic risk and road safety: comparative study between Malaysia and Singapore.

    PubMed

    Khan, Saif ur Rehman; Khalifah, Zainab Binti; Munir, Yasin; Islam, Talat; Nazir, Tahira; Khan, Hashim

    2015-01-01

    The present study aims to investigate differences in road safety attitude, driver behaviour and traffic risk perception between Malaysia and Singapore. A questionnaire-based survey was conducted among a sample of Singaporean (n = 187) and Malaysian (n = 313) road users. The data was analysed using confirmatory factor analysis and structural equation modelling applied to measure comparative fit indices of Malaysian and Singaporean respondents. The results show that the perceived traffic risk of Malaysian respondents is higher than Singaporean counterparts. Moreover, the structural equation modelling has confirmed perceived traffic risk performing the role of full mediation between perceived driving skills and perceived road safety for both the countries, while perceived traffic skills was found to perform the role of partial mediation between aggression and anxiety, on one hand, and road safety, on the other hand, in Malaysia and Singapore. In addition, in both countries, a weak correlation between perceived driving skills, aggression and anxiety with perceived road safety was found, while a strong correlation exists with traffic risk perception. The findings of this study have been discussed in terms of theoretical, practical and conceptual implications for both scholars and policy-makers to better understand the young drivers' attitude and behaviour relationship towards road safety measures with a view to future research. PMID:24974915

  18. Strategies GeoCape Intelligent Observation Studies @ GSFC

    NASA Technical Reports Server (NTRS)

    Cappelaere, Pat; Frye, Stu; Moe, Karen; Mandl, Dan; LeMoigne, Jacqueline; Flatley, Tom; Geist, Alessandro

    2015-01-01

    This presentation provides information a summary of the tradeoff studies conducted for GeoCape by the GSFC team in terms of how to optimize GeoCape observation efficiency. Tradeoffs include total ground scheduling with simple priorities, ground scheduling with cloud forecast, ground scheduling with sub-area forecast, onboard scheduling with onboard cloud detection and smart onboard scheduling and onboard image processing. The tradeoffs considered optimzing cost, downlink bandwidth and total number of images acquired.

  19. Quality Reporting of Multivariable Regression Models in Observational Studies

    PubMed Central

    Real, Jordi; Forné, Carles; Roso-Llorach, Albert; Martínez-Sánchez, Jose M.

    2016-01-01

    Abstract Controlling for confounders is a crucial step in analytical observational studies, and multivariable models are widely used as statistical adjustment techniques. However, the validation of the assumptions of the multivariable regression models (MRMs) should be made clear in scientific reporting. The objective of this study is to review the quality of statistical reporting of the most commonly used MRMs (logistic, linear, and Cox regression) that were applied in analytical observational studies published between 2003 and 2014 by journals indexed in MEDLINE. Review of a representative sample of articles indexed in MEDLINE (n = 428) with observational design and use of MRMs (logistic, linear, and Cox regression). We assessed the quality of reporting about: model assumptions and goodness-of-fit, interactions, sensitivity analysis, crude and adjusted effect estimate, and specification of more than 1 adjusted model. The tests of underlying assumptions or goodness-of-fit of the MRMs used were described in 26.2% (95% CI: 22.0–30.3) of the articles and 18.5% (95% CI: 14.8–22.1) reported the interaction analysis. Reporting of all items assessed was higher in articles published in journals with a higher impact factor. A low percentage of articles indexed in MEDLINE that used multivariable techniques provided information demonstrating rigorous application of the model selected as an adjustment method. Given the importance of these methods to the final results and conclusions of observational studies, greater rigor is required in reporting the use of MRMs in the scientific literature. PMID:27196467

  20. Pedagogical strategies used in clinical medical education: an observational study

    PubMed Central

    2010-01-01

    Background Clinical teaching is a complex learning situation influenced by the learning content, the setting and the participants' actions and interactions. Few empirical studies have been conducted in order to explore how clinical supervision is carried out in authentic situations. In this study we explore how clinical teaching is carried out in a clinical environment with medical students. Methods Following an ethnographic approach looking for meaning patterns, similarities and differences in how clinical teachers manage clinical teaching; non-participant observations and informal interviews were conducted during a four month period 2004-2005. The setting was at a teaching hospital in Sweden. The participants were clinical teachers and their 4th year medical students taking a course in surgery. The observations were guided by the aim of the study. Observational notes and notes from informal interviews were transcribed after each observation and all data material was analysed qualitatively. Results Seven pedagogical strategies were found to be applied, namely: 1) Questions and answers, 2) Lecturing, 3) Piloting, 4) Prompting, 5) Supplementing, 6) Demonstrating, and 7) Intervening. Conclusions This study contributes to previous research in describing a repertoire of pedagogical strategies used in clinical education. The findings showed that three superordinate qualitatively different ways of teaching could be identified that fit Ramsden's model. Each of these pedagogical strategies encompass different focus in teaching; either a focus on the teacher's knowledge and behaviour or the student's behaviour and understanding. We suggest that an increased awareness of the strategies in use will increase clinical teachers' teaching skills and the consequences they will have on the students' ability to learn. The pedagogical strategies need to be considered and scrutinized in further research in order to verify their impact on students' learning. PMID:20105340

  1. The new worlds observer: The astrophysics strategic mission concept study

    NASA Astrophysics Data System (ADS)

    Cash, W.

    2011-07-01

    We present some results of the Astrophysics Strategic Mission Concept Study for the New Worlds Observer (NWO). We show that the use of starshades is the most effective and affordable path to mapping and understanding our neighboring planetary systems, to opening the search for life outside our solar system, while serving the needs of the greater astronomy community. A starshade-based mission can be implemented immediately with a near term program of technology demonstration.

  2. Observational and theoretical studies of rich clusters with multiple subcondensations

    NASA Technical Reports Server (NTRS)

    Geller, M. J.; Huchra, J. P.

    1984-01-01

    Observational and theoretical studies of the formation and evolution of clusters of galaxies are investigated. The relationship between the properties of individual galaxies and their environment is examined. Perphaps the most remarkable physical result derived from these is the apparent substructure in redishift position space. The distribution of spiral galaxies is quite different from the distribution of the ellipticals. The velocity distribution for the spirals is also substantially broader than the distribution for the ellipticals.

  3. Safety and Efficacy of Zonisamide in Patients with Epilepsy: A Post-Marketing Surveillance Study

    PubMed Central

    Lee, Hye Jin; Son, Jeong Min; Mun, Jihee; Kim, Dong Wook

    2015-01-01

    Background and Purpose: Zonisamide (ZNS) is one of new antiepileptic drug, which is known to inhibit seizure through multiple mechanisms of action. In Korea, ZNS was approved as an antiepileptic drug in 1992 and has been used for epilepsy patients with partial and generalized seizures. The objective of this study was to investigate the efficacy and tolerability of ZNS in patients with epilepsy and to identify the incidence of adverse events in real clinical setting. Methods: This study was carried out in patients who received ZNS for epilepsy. Patients who were observed for at least 12 weeks after treatment with ZNS were included as evaluable subjects. Information regarding the status and type of adverse events occurring during the course of treatment with ZNS was obtained regardless of causal relationship to ZNS and efficacy was assessed by the study physicians and patients at 12 weeks post dose of ZNS. Results: A total of 1,948 patients were included in the study, and ZNS efficacy was evaluated in 1,744 patients. ZNS was used as a monotherapy in 1,095 patients and as an adjunctive drug in 853 patients. Of the total patients, 1,345 (69.1%) patients had partial seizure, 563 patients had generalized seizure, and 40 patients were undetermined. Adverse events were reported in 65 patients (3.34%) including 1 case of Stevens-Johnson syndrome, but no incidence of serious unexpected adverse drug reactions were reported. 755 patients (43.29%) became seizure free with ZNS treatment, and additional 322 patients (18.41%) experienced marked improvement with ZNS treatment. Conclusions: Our study shows the safety and tolerability of ZNS treatment in patients with epilepsy in real clinical setting. In addition, ZNS was found to be an effective option as a monotherapy or in patients with generalized seizure. PMID:26819941

  4. Patient safety in the operating room: an intervention study on latent risk factors

    PubMed Central

    2012-01-01

    Background Patient safety is one of the greatest challenges in healthcare. In the operating room errors are frequent and often consequential. This article describes an approach to a successful implementation of a patient safety program in the operating room, focussing on latent risk factors that influence patient safety. We performed an intervention to improve these latent risk factors (LRFs) and increase awareness of patient safety issues amongst OR staff. Methods Latent risk factors were studied using a validated questionnaire applied to the OR staff before and after an intervention. A pre-test/post-test control group design with repeated measures was used to evaluate the effects of the interventions. The staff from one operating room of an university hospital acted as the intervention group. Controls consisted of the staff of the operating room in another university hospital. The outcomes were the changes in LRF scores, perceived incident rate, and changes in incident reports between pre- and post-intervention. Results Based on pre-test scores and participants’ key concerns about organizational factors affecting patient safety in their department the intervention focused on the following LRFs: Material Resources, Training and Staffing Recourses. After the intervention, the intervention operating room - compared to the control operating room - reported significantly fewer problems on Material Resources and Staffing Resources and a significantly lower score on perceived incident rate. The contribution of technical factors to incident causation decreased significantly in the intervention group after the intervention. Conclusion The change of state of latent risk factors can be measured using a patient safety questionnaire aimed at these factors. The change of the relevant risk factors (Material and Staffing resources) concurred with a decrease in perceived and reported incident rates in the relevant categories. We conclude that interventions aimed at unfavourable

  5. Codifying knowledge to improve patient safety: a qualitative study of practice-based interventions.

    PubMed

    Turner, Simon; Higginson, Juliet; Oborne, C Alice; Thomas, Rebecca E; Ramsay, Angus I G; Fulop, Naomi J

    2014-07-01

    Although it is well established that health care professionals use tacit and codified knowledge to provide front-line care, less is known about how these two forms of knowledge can be combined to support improvement related to patient safety. Patient safety interventions involving the codification of knowledge were co-designed by university and hospital-based staff in two English National Health Service (NHS) hospitals to support the governance of medication safety and mortality and morbidity (M&M) meetings. At hospital A, a structured mortality review process was introduced into three clinical specialities from January to December 2010. A qualitative approach of observing M&M meetings (n = 30) and conducting interviews (n = 40) was used to examine the impact on meetings and on front-line clinicians and hospital managers. At hospital B, a medication safety 'scorecard' was administered on a general medicine and elderly care ward from September to November 2011. Weekly feedback meetings were observed (n = 18) and interviews with front-line staff conducted (n = 10) to examine how knowledge codification influenced behaviour. Codification was shown to support learning related to patient safety at the micro (front-line service) level by structuring the sharing of tacit knowledge, but the presence of professional and managerial boundaries at the organisational level affected the codification initiatives' implementation. The findings suggest that codifying knowledge to support improvement presents distinct challenges at the group and organisational level; translating knowledge across these levels is contingent on the presence of enabling organisational factors, including the alignment of learning from clinical practice with its governance. PMID:24880659

  6. Observational studies of reconnection in the solar corona

    SciTech Connect

    McKenzie, David E.

    2011-11-15

    In recent years, observational studies of the corona have shifted focus. Where they were once purely qualitative morphological explorations seeking to support the presence of reconnection, more investigations are providing empirical estimates of the physical conditions in the reconnecting corona. These studies are enabled and enhanced by orbiting telescopes with high angular and temporal resolution. In this article, some recent findings about the empirical quantities are reviewed, including recent estimates of the flux transferred in individual patchy reconnection episodes, the size distribution of post-reconnection flux tubes, and the energy released by the flux tubes as they shrink.

  7. Tropospheric Chemistry Studies using Observations from GOME and TOMS

    NASA Technical Reports Server (NTRS)

    Chance, Kelly; Spurr, Robert J. D.; Kurosu, Thomas P.; Jacob, Daniel J.; Gleason, James F.

    2003-01-01

    Studies to quantitatively determine trace gas and aerosol amounts from the Global Ozone Monitoring Experiment (GOME) and the Total Ozone Monitoring Experiment (TOMS) and to perform chemical modeling studies which utilize these results are given. This includes: 1. Analysis of measurements from the GOME and TOMS instruments for troposphere distributions of O3 and HCHO; troposphere enhancements of SO2, NO2 and aerosols associated with major sources; and springtime events of elevated BrO in the lower Arctic troposphere. 2. Application of a global 3-dimensional model of troposphere chemistry to interpret the GOME observations in terms of the factors controlling the abundances of troposphere ozone and OH.

  8. The SHIELD (Safety & Health Improvement: Enhancing Law Enforcement Departments) Study: Mixed Methods Longitudinal Findings.

    PubMed

    Kuehl, Kerry S; Elliot, Diane L; MacKinnon, David P; O'Rourke, Holly P; DeFrancesco, Carol; Miočević, Milica; Valente, Matthew; Sleigh, Adriana; Garg, Bharti; McGinnis, Wendy; Kuehl, Hannah

    2016-05-01

    The SHIELD (Safety & Health Improvement: Enhancing Law Enforcement Departments) Study is a worksite wellness team-based intervention among police and sheriff departments assessing the program's effectiveness to reduce occupational risks and unhealthy lifestyle behaviors. The SHIELD program focused on improving diet, physical activity, body weight and sleep, and reducing the effects of unhealthy stress and behaviors, such as tobacco and substance abuse. The SHIELD team-based health promotion program was found to be feasible and effective at 6 months in improving diet, sleep, stress, and overall quality of life of law enforcement department personnel. Both intervention and control groups were followed for 24 months, and we report those durability findings, along with qualitative group interview results that provide insight into the changes of the long-term outcomes. Long-term effects were observed for consumption of fruits and vegetables, and there was some evidence for effects on tobacco and alcohol use. Assessment of dietary habits, physical activity behaviors, weight loss maintenance, and substance use is rare more than 1 year following an intervention, and in general, initial positive changes do not persist in prior research. The SHIELD program was feasible, effective, and durable for improving dietary changes. PMID:27158956

  9. Assessment of radiation safety awareness among nuclear medicine nurses: a pilot study

    NASA Astrophysics Data System (ADS)

    Yunus, N. A.; Abdullah, M. H. R. O.; Said, M. A.; Ch'ng, P. E.

    2014-11-01

    All nuclear medicine nurses need to have some knowledge and awareness on radiation safety. At present, there is no study to address this issue in Malaysia. The aims of this study were (1) to determine the level of knowledge and awareness on radiation safety among nuclear medicine nurses at Putrajaya Hospital in Malaysia and (2) to assess the effectiveness of a training program provided by the hospital to increase the knowledge and awareness of the nuclear medicine nurses. A total of 27 respondents attending a training program on radiation safety were asked to complete a questionnaire. The questionnaire consists 16 items and were categorized into two main areas, namely general radiation knowledge and radiation safety. Survey data were collected before and after the training and were analyzed using descriptive statistics and paired sample t-test. Respondents were scored out of a total of 16 marks with 8 marks for each area. The findings showed that the range of total scores obtained by the nuclear medicine nurses before and after the training were 6-14 (with a mean score of 11.19) and 13-16 marks (with a mean score of 14.85), respectively. Findings also revealed that the mean score for the area of general radiation knowledge (7.59) was higher than that of the radiation safety (7.26). Currently, the knowledge and awareness on radiation safety among the nuclear medicine nurses are at the moderate level. It is recommended that a national study be conducted to assess and increase the level of knowledge and awareness among all nuclear medicine nurses in Malaysia.

  10. Factors affecting recruitment to an observational multicentre palliative care study

    PubMed Central

    Stone, Patrick C; Gwilliam, Bridget; Keeley, Vaughan; Todd, Chris; Kelly, Laura C; Barclay, Stephen

    2013-01-01

    Objectives To identify those factors which adversely affected recruitment to a large multicentre palliative care study. Methods Patient accrual to a multicentre, observational, palliative care study was monitored at three critical junctures in the research process. (1) Eligibility—did the patient fulfil the study entry criteria? (2) Accessibility—was it possible to access the patient to be able to inform them about the study? (3) Consent—did the patient agree to participate in the study? The reasons why patients were ineligible, inaccessible or refused consent were recorded. Results 12 412 consecutive referrals to participating clinical services were screened for study inclusion of whom 5394 (43%) were deemed to be ineligible. Of the remaining patients 4617/7018 (66%) were inaccessible to the research team. The most common reasons being precipitous death, ‘gatekeeping’ by clinical staff or rapid discharge. Of the 2410 patients who were visited by the research team and asked to participate in the study 1378 (57%) declined. Overall 8.2% (1018/12 412) of patients screened participated in the study. There were significant differences in recruitment patterns between hospice inpatient units, hospital support and community palliative care teams. Conclusions Systematic monitoring and analysis of patient flows through the clinical trial accrual process provided valuable insights about the reasons for failure to recruit patients to a clinical trial and may help to improve recruitment in future studies. PMID:24644750

  11. The Safety and Effects of the Beta-Blocker, Nadolol, in Mild Asthma; An Open-label Pilot Study

    PubMed Central

    Hanania, Nicola A; Singh, Supria; Eli-Wali, Rami; Flashner, Michael; Franklin, Amie E; Garner, William J; Dickey, Burton F; Parra, Sergio; Ruoss, Stephen J; Shardonofsky, Felix; O'Connor, Brian J; Page, Clive; Bond, Richard A

    2008-01-01

    Beta-blockers are currently contraindicated in asthma because their acute administration may be associated with worsening bronchospasm. However, their effects and safety with their chronic administration are not well evaluated. The rationale for this pilot study was based on the paradigm shift that was observed with the use of beta-blockers in congestive heart failure which once contraindicated because of their acute detrimental effects, have now been shown to reduce mortality with their chronic use. We hypothesized that certain beta-blockers may also be safe and useful in chronic asthma therapy. In this prospective, open-label, pilot study, we evaluated the safety and effects of escalating doses of the beta-blocker, nadolol, administered over 9 weeks to 10 subjects with mild asthma. Dose escalation was performed on a weekly basis based on pre-determined safety lung function, asthma control and hemodynamic parameters. The primary objective was to evaluate safety and secondary objectives were to evaluate effects on airway hyperresponsiveness, and indices of respiratory function. The escalating administration of nadolol was well tolerated. In 8 out of the 10 subjects, nine weeks of nadolol treatment produced a significant, dose-dependent increase in PC20 that reached 2.1 doubling doses at 40 mg (p < 0.0042). However, there was also a dose-independent 5% reduction in mean FEV1 over the study period (p < 0.01). We conclude that in most patients with mild asthma, the dose-escalating administration of the beta-blocker, nadolol, is well tolerated and may have beneficial effects on airway hyperresponsiveness. Our findings warrant further testing in future larger trials. PMID:17703976

  12. Exploring the Limits to Observational Diffuse Interstellar Band Studies

    NASA Astrophysics Data System (ADS)

    Foing, B. H.

    2014-02-01

    The status of DIB research (Herbig 1995) has strongly advanced since the DIB conference in Boulder in 1994. In the same year we reported the discovery of two near IR diffuse bands coincident with C60 +, that was confirmed in subsequent years. Since then a number of DIB observational studies have been published such as DIB surveys, measurements of DIB families, correlations and environment dependences as well as DIBs in extra-galactic sources. Resolved substructures were measured and compared to predicted rotational contours of large molecules. Polarisation studies provided constraints on possible carrier molecules and upper limits. DIBs carriers have been linked with several classes of organic molecules observed in the interstellar medium, in particular to the UIR bands (assigned to PAHs), the Extended Red Emission (ERE) or the recently detected Anomalous Microwave Emission (AME, assigned to spinning dust). In particular fullerenes and PAHs have been proposed to explain some DIBs and specific molecules were searched for in DIB spectra. DIB carriers could be present in various dehydrogenation and ionization states. Experiments in the laboratory and in space contribute to our understanding of the photo-stability of possible DIB carriers. In summary, the status of DIB research in the last 20 years has strongly advanced. We review DIB observational results and their interpretation and introduce the relevant plenary discussion.

  13. Effectiveness of an improved road safety policy in Ethiopia: an interrupted time series study

    PubMed Central

    2014-01-01

    Background In recent years, there has been an increasing interest in implementing road safety policy by different low income countries. However; the evidence is scarce on its success in the reduction of crashes, injuries and deaths. This study was conducted to assess whether road crashes, injuries and fatalities was reduced following the road safety regulation introduced as of September 2007 by Oromia Regional State Transport Bureau. Methods Routine road traffic accident data for the year 2002-2011were collected from sixteen traffic police offices. Data on average daily vehicle flow was obtained from the Ethiopian Road Authority. Interrupted time series design using segmented linear regression model was applied to estimate the effect of an improved road safety policy. Results A total of 4,053 crashes occurred on Addis Ababa - Adama/Hawassa main road. Of these crashes, almost half 46.4% (1,880) were property damage, 29.4% (1,193) were fatal and 24.2% (980) injury crashes, resulting 1,392 fatalities and 1,749 injuries. There were statistically significant reductions in non-injury crashes and deaths. Non-injury crash was reduced by 19% and fatality by 12.4% in the first year of implementing the revised transport safety regulation. Conclusion Although revised road safety policy helped in reducing motor vehicle crashes and associated fatalities, the overall incidence rate is still very high. Further action is required to avoid unnecessary loss of lives. PMID:24886220

  14. Preliminary planning study for safety relief valve experiments in a Mark III BWR pressure suppression system

    SciTech Connect

    McCauley, E.W.; Holman, G.S.

    1980-04-21

    In response to a request from the Water Reactor Safety Research Division of the US NRC, a preliminary study is provided which identifies key features and consideration involved in planning a comprehensive in-plant Safety Relief Valve experimental program for a Mark III containment design. The report provides identification of program objectives, measurement system requirements, and some details quantifying expected system response. In addition, a preliminary test matrix is outlined which involves a supporting philosophy intended to enhance the usefulness of the experimental results for all members of the program team: experimentalists, analysts, and plant operator.

  15. Nuclear electric propulsion operational reliability and crew safety study: NEP systems/modeling report

    NASA Technical Reports Server (NTRS)

    Karns, James

    1993-01-01

    The objective of this study was to establish the initial quantitative reliability bounds for nuclear electric propulsion systems in a manned Mars mission required to ensure crew safety and mission success. Finding the reliability bounds involves balancing top-down (mission driven) requirements and bottom-up (technology driven) capabilities. In seeking this balance we hope to accomplish the following: (1) provide design insights into the achievability of the baseline design in terms of reliability requirements, given the existing technology base; (2) suggest alternative design approaches which might enhance reliability and crew safety; and (3) indicate what technology areas require significant research and development to achieve the reliability objectives.

  16. Managing Quality and Safety in Real Time? Evidence from an Interview Study.

    PubMed

    Randell, Rebecca; Keen, Justin; Gates, Cara; Ferguson, Emma; Long, Andrew; Ginn, Claire; McGinnis, Elizabeth; Whittle, Jackie

    2016-01-01

    Health systems around the world are investing increasing effort in monitoring care quality and safety. Dashboards can support this process, providing summary data on processes and outcomes of care, making use of data visualization techniques such as graphs. As part of a study exploring development and use of dashboards in English hospitals, we interviewed senior managers across 15 healthcare providers. Findings revealed substantial variation in sophistication of the dashboards in place, largely presenting retrospective data items determined by national bodies and dependent on manual collation from a number of systems. Where real time systems were in place, they supported staff in proactively managing quality and safety. PMID:27577334

  17. Hand Safety

    MedlinePlus

    ... en gatillo See More... Hand Anatomy Hand Safety Fireworks Safety Lawnmower Safety Snowblower safety Pumpkin Carving Gardening ... en gatillo See More... Hand Anatomy Hand Safety Fireworks Safety Lawnmower Safety Snowblower safety Pumpkin Carving Gardening ...

  18. Hand Safety

    MedlinePlus

    ... Fireworks Safety Lawnmower Safety Snowblower safety Pumpkin Carving Gardening Safety Turkey Carving Removing a Ring Español Artritis ... Fireworks Safety Lawnmower Safety Snowblower safety Pumpkin Carving Gardening Safety Turkey Carving Removing a Ring Español Artritis ...

  19. Studies of Tropical/Mid-Latitude Exchange Using UARS Observations

    NASA Technical Reports Server (NTRS)

    Avallone, Linnea

    2001-01-01

    At the time this proposal was submitted, recent publications had suggested an important role for transport of midlatitude air into the tropical lower stratosphere. Most of these studies had employed data that gave only a time-averaged picture, making it difficult to determine the nature of the transport processes responsible for the observed behavior. We proposed to analyze observations of long-lived trace gases, such as nitric acid, methane, nitrous oxide, and chlorofluorocarbons, made from the Upper Atmosphere Research Satellite, to investigate the seasonal behavior of mixing between the midlatitudes and tropics. We planned to construct probability distributions of the concentrations of these species over small altitude ranges and to compare them to expectations based on modeled mean concentrations and knowledge of instrument precision. Differences from expectation were to be analyzed with respect to meteorological parameters to determine whether wave activity may have induced apparent mixing.

  20. Linking Indigenous Knowledge and Observed Climate Change Studies

    NASA Technical Reports Server (NTRS)

    Alexander, Chief Clarence; Bynum, Nora; Johnson, Liz; King, Ursula; Mustonen, Tero; Neofotis, Peter; Oettle, Noel; Rosenzweig, Cynthia; Sakakibara, Chie; Shadrin, Chief Vyacheslav; Vicarelli, Marta; Waterhouse, Jon; Weeks, Brian

    2010-01-01

    We present indigenous knowledge narratives and explore their connections to documented temperature and other climate changes and observed climate change impact studies. We then propose a framework for enhancing integration of these indigenous narratives of observed climate change with global assessments. Our aim is to contribute to the thoughtful and respectful integration of indigenous knowledge with scientific data and analysis, so that this rich body of knowledge can inform science, and so that indigenous and traditional peoples can use the tools and methods of science for the benefit of their communities if they choose to do so. Enhancing ways of understanding such connections are critical as the Intergovernmental Panel on Climate Change Fifth Assessment process gets underway.

  1. Supplementing Oscat winds with Saral Altika observations for cyclone studies

    NASA Astrophysics Data System (ADS)

    Niharika, K.; Usha Sundari, H. S. V.; Prasad, A. V. V.; Kumari, E. V. S. Sita; Dadhwal, V. K.; Ali, M. M.

    2014-11-01

    Accurate prediction of life cycle of cyclone is very critical to the disaster management practices. Since the cyclones originate over the oceans where in situ observations are limited, we have to resort to the remote sensing techniques. Both optical and microwave sensors help studying the cyclones. While scatterometer provide wind vectors, altimeters can give only wind speed. In this paper we present how altimeter measurements can supplement the scatterometer observations in determining the radius of maximum winds (RMW). Sustained maximum winds, indicator for the intensity of the cyclone, are within the eye wall of a cyclone at a distance of RMW. This parameter is also useful in predicting right time of the storm surge. In this paper we used the wind speed estimations from AltiKa, an altimeter operating at Ka band.

  2. A Case Study of Measuring Process Risk for Early Insights into Software Safety

    NASA Technical Reports Server (NTRS)

    Layman, Lucas; Basili, Victor; Zelkowitz, Marvin V.; Fisher, Karen L.

    2011-01-01

    In this case study, we examine software safety risk in three flight hardware systems in NASA's Constellation spaceflight program. We applied our Technical and Process Risk Measurement (TPRM) methodology to the Constellation hazard analysis process to quantify the technical and process risks involving software safety in the early design phase of these projects. We analyzed 154 hazard reports and collected metrics to measure the prevalence of software in hazards and the specificity of descriptions of software causes of hazardous conditions. We found that 49-70% of 154 hazardous conditions could be caused by software or software was involved in the prevention of the hazardous condition. We also found that 12-17% of the 2013 hazard causes involved software, and that 23-29% of all causes had a software control. The application of the TPRM methodology identified process risks in the application of the hazard analysis process itself that may lead to software safety risk.

  3. Presurgical navigated TMS motor cortex mapping improves outcome in glioblastoma surgery: a controlled observational study.

    PubMed

    Picht, Thomas; Frey, Dietmar; Thieme, Stefan; Kliesch, Stefan; Vajkoczy, Peter

    2016-02-01

    The authors report on an observational study designed to isolate the impact of navigated transcranial magnetic stimulation (nTMS) on surgical outcome in glioblastoma treatment. We undertook a controlled observational study to identify the additive impact of presurgical nTMS in patients scheduled for surgical treatment of glioblastoma in or near motor eloquent locations. The trial data is derived from a large university hospital with a differential availability of its nTMS mapping service at its two campuses, both equally served by a single neurosurgical department. When available, the nTMS cortical mapping data and nTMS-based fiber tractography are used for surgical planning and patient counseling as well as intraoperative identification of the primary motor cortex and guidance in subcortical motor mapping. The addition of preoperative nTMS mapping data to a clinical routine already incorporating preoperative fiber tractography and intraoperative neuronavigation and electrophysiology was shown to improve surgical outcomes by increasing the extent of resection, without compromising patient safety or long-term functional outcomes in comparison to the concurrent non-TMS control group. This study is the first to prove that the improved surgical outcomes observed in previous studies after the implementation of nTMS to presurgical work-up are not caused by any overall improvement in patient care or a paradigm shift toward more aggressive resection but by the additional functional data provided by nTMS. PMID:26566653

  4. 40 CFR 725.92 - Data from health and safety studies of microorganisms.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Data from health and safety studies of microorganisms. 725.92 Section 725.92 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC... not in any way related to the effects of a microorganism on health or the environment, such as,...

  5. 40 CFR 720.90 - Data from health and safety studies.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Data from health and safety studies. 720.90 Section 720.90 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC... human health or the environment, such as the name of the submitting company, cost or other...

  6. A Study of Truck Drivers and Their Job Performance Regarding Highway Safety

    ERIC Educational Resources Information Center

    Nafukho, Fredrick M.; Hinton, Barbara E.; Graham, Carroll M.

    2007-01-01

    Limited research has addressed the issue of truck drivers and their performance regarding highway safety in terms of reduced number of crashes per driver. The primary purpose of this study was to determine how tractor trailer truck drivers' job performance could be improved while at the same time ensuring increased revenue for the transportation…

  7. 40 CFR 725.92 - Data from health and safety studies of microorganisms.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 32 2012-07-01 2012-07-01 false Data from health and safety studies of microorganisms. 725.92 Section 725.92 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS Confidentiality and Public Access to...

  8. Perceptions of Psychological and Physical Safety Environments of Information Technology Employees: A Phenomenological Study

    ERIC Educational Resources Information Center

    Payne, Sheila C.

    2012-01-01

    A qualitative phenomenological study was conducted to gain a deeper understanding of psychological and safety environments of an oil and gas multinational enterprise. Twenty information technology professionals were interviewed to explore their feelings, perceptions, beliefs, and values of the phenomenon. The interviews elicited data about facets…

  9. How Safe Is a School? An Exploratory Study Comparing Measures and Perceptions of Safety

    ERIC Educational Resources Information Center

    Hernandez, Diley; Floden, Lysbeth; Bosworth, Kris

    2010-01-01

    This exploratory study investigates the relation between incident reports to local law enforcement, and students' and teachers' perceptions of school safety. Using a combination of grounded theory and statistics, we compared quantitative data collected from law enforcement agencies with qualitative data provided by students and teachers during…

  10. 40 CFR 725.92 - Data from health and safety studies of microorganisms.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... microorganisms. 725.92 Section 725.92 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS Confidentiality and Public Access to Information § 725.92 Data from health and safety studies of microorganisms....

  11. Development and Evaluation of a Multi-Institutional Case Studies-Based Course in Food Safety

    ERIC Educational Resources Information Center

    Pleitner, Aaron M.; Chapin, Travis K.; Hammons, Susan R.; Stelten, Anna Van; Nightingale, Kendra K.; Wiedmann, Martin; Johnston, Lynette M.; Oliver, Haley F.

    2015-01-01

    Developing novel, engaging courses in food safety is necessary to train professionals in this discipline. Courses that are interactive and case-based encourage development of critical thinking skills necessary for identifying and preventing foodborne disease outbreaks. The purpose of this study was to assess the efficacy of a case study…

  12. A safety study of a novel photosensitizer, sinoporphyrin sodium, for photodynamic therapy in Beagle dogs.

    PubMed

    Lin, Ni; Li, Chao; Wang, Zhonghua; Zhang, Jingxuan; Ye, Xiangfeng; Gao, Wenjing; Wang, Aiping; Jin, Hongtao; Wei, Jinfeng

    2015-04-01

    Sinoporphyrin sodium (DVDMS) is a novel hematoporphyrin-like photosensitizer developed for photodynamic therapy (PDT), an effective therapeutic modality for tumor treatment; however, the safety of photosensitizer-based PDT is always of great concern. The purpose of the current study was to investigate the potential repeated-dose toxicity and describe the toxicokinetic process of DVDMS-based PDT in Beagle dogs. The dogs were randomly allocated to six groups, and then were administrated a DVDMS preparation intravenously at dose levels of 0, 1, 3, 9, 1 and 9 mg per kg body weight, respectively; then, the latter two groups were illuminated 24 h later with a 630 nm laser for 10 min, once every seven days for 5 weeks. During the study period, clinical signs, mortality, body weight, food consumption, body temperature, ophthalmoscopy, hematology, serum biochemistry, urinalysis, electrocardiograms, toxicokinetics, organ weights, gross anatomy and histopathology were examined. After the administration, no deaths were observed; however, the dogs that received PDT showed skin swelling and ulceration, indicating that DVDMS-PDT induced a phototoxic effect. DVDMS led to an increase in blood coagulation in dogs in the 9 mg kg(-1) group and in the two PDT groups on Day 35, whereas it induced a decrease in dogs in the 3 mg kg(-1) group and in the two PDT groups on Day 49. The toxicokinetic study showed that the systematic exposure of DVDMS in dogs occurred in a dose-dependent manner, and DVDMS did not accumulate in blood plasma. The DVDMS-based PDT group showed no obvious treatment-related pathological changes; however, slight or mild brown-and-yellow pigmentation of DVDMS (or its metabolite) was observed to deposit in the liver, spleen, local lymph nodes and marrow of dogs in the mid- and high-dose groups, as well as the high-dose PDT group. In females, the absolute and relative spleen weights increased in dogs in the 9 mg kg(-1) DVDMS groups with and without PDT during the

  13. ADAPTIVE MATCHING IN RANDOMIZED TRIALS AND OBSERVATIONAL STUDIES

    PubMed Central

    van der Laan, Mark J.; Balzer, Laura B.; Petersen, Maya L.

    2014-01-01

    SUMMARY In many randomized and observational studies the allocation of treatment among a sample of n independent and identically distributed units is a function of the covariates of all sampled units. As a result, the treatment labels among the units are possibly dependent, complicating estimation and posing challenges for statistical inference. For example, cluster randomized trials frequently sample communities from some target population, construct matched pairs of communities from those included in the sample based on some metric of similarity in baseline community characteristics, and then randomly allocate a treatment and a control intervention within each matched pair. In this case, the observed data can neither be represented as the realization of n independent random variables, nor, contrary to current practice, as the realization of n/2 independent random variables (treating the matched pair as the independent sampling unit). In this paper we study estimation of the average causal effect of a treatment under experimental designs in which treatment allocation potentially depends on the pre-intervention covariates of all units included in the sample. We define efficient targeted minimum loss based estimators for this general design, present a theorem that establishes the desired asymptotic normality of these estimators and allows for asymptotically valid statistical inference, and discuss implementation of these estimators. We further investigate the relative asymptotic efficiency of this design compared with a design in which unit-specific treatment assignment depends only on the units’ covariates. Our findings have practical implications for the optimal design and analysis of pair matched cluster randomized trials, as well as for observational studies in which treatment decisions may depend on characteristics of the entire sample. PMID:25097298

  14. Globally Gridded Satellite (GridSat) Observations for Climate Studies

    NASA Technical Reports Server (NTRS)

    Knapp, Kenneth R.; Ansari, Steve; Bain, Caroline L.; Bourassa, Mark A.; Dickinson, Michael J.; Funk, Chris; Helms, Chip N.; Hennon, Christopher C.; Holmes, Christopher D.; Huffman, George J.; Kossin, James P.; Lee, Hai-Tien; Loew, Alexander; Magnusdottir, Gudrun

    2012-01-01

    Geostationary satellites have provided routine, high temporal resolution Earth observations since the 1970s. Despite the long period of record, use of these data in climate studies has been limited for numerous reasons, among them: there is no central archive of geostationary data for all international satellites, full temporal and spatial resolution data are voluminous, and diverse calibration and navigation formats encumber the uniform processing needed for multi-satellite climate studies. The International Satellite Cloud Climatology Project set the stage for overcoming these issues by archiving a subset of the full resolution geostationary data at approx.10 km resolution at 3 hourly intervals since 1983. Recent efforts at NOAA s National Climatic Data Center to provide convenient access to these data include remapping the data to a standard map projection, recalibrating the data to optimize temporal homogeneity, extending the record of observations back to 1980, and reformatting the data for broad public distribution. The Gridded Satellite (GridSat) dataset includes observations from the visible, infrared window, and infrared water vapor channels. Data are stored in the netCDF format using standards that permit a wide variety of tools and libraries to quickly and easily process the data. A novel data layering approach, together with appropriate satellite and file metadata, allows users to access GridSat data at varying levels of complexity based on their needs. The result is a climate data record already in use by the meteorological community. Examples include reanalysis of tropical cyclones, studies of global precipitation, and detection and tracking of the intertropical convergence zone.

  15. Safety of bevacizumab in clinical practice for recurrent ovarian cancer: A retrospective cohort study

    PubMed Central

    SELLE, FRÉDÉRIC; EMILE, GEORGE; PAUTIER, PATRICIA; ASMANE, IRÈNE; SOARES, DANIELE G.; KHALIL, AHMED; ALEXANDRE, JEROME; LHOMMÉ, CATHERINE; RAY-COQUARD, ISABELLE; LOTZ, JEAN-PIERRE; GOLDWASSER, FRANÇOIS; TAZI, YOUSSEF; HEUDEL, PIERRE; PUJADE-LAURAINE, ERIC; GOUY, SÉBASTIEN; TREDAN, OLIVIER; BARBAZA, MARIE O.; ADY-VAGO, NORA; DUBOT, CORALINE

    2016-01-01

    The poor outcome of patients with recurrent ovarian cancer constitutes a continuous challenge for decision-making in clinical practice. In this setting, molecular targets have recently been identified, and novel compounds are now available. Bevacizumab has been introduced for the treatment of patients with ovarian cancer and is, to date, the most extensively investigated targeted therapy in this setting. However, potential toxicities are associated with the use of this monoclonal antibody. These toxicities have been reported in clinical trials, and can also be observed outside of trials. As limited data is currently available regarding the safety of bevacizumab treatment in daily clinical practice, the current retrospective study was designed to evaluate this. Data from 156 patients with recurrent ovarian cancer who had received bevacizumab treatment between January 2006 and June 2009 were retrospectively identified from the institutional records of five French centers. In contrast to clinical trials, the patients in the present study were not selected and had a heterogeneous profile according to their prior medical history, lines of treatment prior to bevacizumab introduction and number of relapses. The results first confirm the effect of heavy pretreatment on the occurrence of serious and fatal adverse events in clinical practice, as previously reported for clinical trials and for other retrospective cohort studies. Importantly, the data also demonstrates, for the first time, that medical history of hypertension is an independent predictive risk factor for the development of high-grade hypertension during bevacizumab treatment. These results thus suggest that treating physicians must consider all risk factors for managing bevacizumab toxicity prior to its introduction. Such risk factors include the time of bevacizumab introduction, a patient's history of hypertension and a low incidence of pre-existing obstructive disease. PMID:26998090

  16. What Counts? An Ethnographic Study of Infection Data Reported to a Patient Safety Program

    PubMed Central

    Dixon-Woods, Mary; Leslie, Myles; Bion, Julian; Tarrant, Carolyn

    2012-01-01

    Context Performance measures are increasingly widely used in health care and have an important role in quality. However, field studies of what organizations are doing when they collect and report performance measures are rare. An opportunity for such a study was presented by a patient safety program requiring intensive care units (ICUs) in England to submit monthly data on central venous catheter bloodstream infections (CVC-BSIs). Methods We conducted an ethnographic study involving ∼855 hours of observational fieldwork and 93 interviews in 17 ICUs plus 29 telephone interviews. Findings Variability was evident within and between ICUs in how they applied inclusion and exclusion criteria for the program, the data collection systems they established, practices in sending blood samples for analysis, microbiological support and laboratory techniques, and procedures for collecting and compiling data on possible infections. Those making decisions about what to report were not making decisions about the same things, nor were they making decisions in the same way. Rather than providing objective and clear criteria, the definitions for classifying infections used were seen as subjective, messy, and admitting the possibility of unfairness. Reported infection rates reflected localized interpretations rather than a standardized dataset across all ICUs. Variability arose not because of wily workers deliberately concealing, obscuring, or deceiving but because counting was as much a social practice as a technical practice. Conclusions Rather than objective measures of incidence, differences in reported infection rates may reflect, at least to some extent, underlying social practices in data collection and reporting and variations in clinical practice. The variability we identified was largely artless rather than artful: currently dominant assumptions of gaming as responses to performance measures do not properly account for how categories and classifications operate in the

  17. A statistical study of merging galaxies: Theory and observations

    NASA Technical Reports Server (NTRS)

    Chatterjee, Tapan K.

    1990-01-01

    A study of the expected frequency of merging galaxies is conducted, using the impulsive approximation. Results indicate that if we consider mergers involving galaxy pairs without halos in a single crossing time or orbital period, the expected frequency of mergers is two orders of magnitude below the observed value for the present epoch. If we consider mergers involving several orbital periods or crossing times, the expected frequency goes up by an order of magnitude. Preliminary calculation indicate that if we consider galaxy mergers between pairs with massive halos, the merger is very much hastened.

  18. How safe do teenagers behave on Facebook? An observational study.

    PubMed

    Vanderhoven, Ellen; Schellens, Tammy; Valcke, Martin; Raes, Annelies

    2014-01-01

    The substantial use of social network sites by teenagers has raised concerns about privacy and security. Previous research about behavior on social network sites was mostly based on surveys and interviews. Observational research overcomes problems inherent to this research method, for example social desirability. However, existing observational research mostly focuses on public profiles of young adults. Therefore, the current observation-study includes 1050 public and non-public Facebook-profiles of teenagers (13-18) to investigate (1) what kind of information teenagers post on their profile, (2) to what extent they protect this information using privacy-settings and (3) how much risky information they have on their profile. It was found that young people mostly post pictures, interests and some basic personal information on their profile. Some of them manage their privacy-settings as such that this information is reserved for friends' eyes only, but a lot of information is accessible on the friends-of-friends' pages. Although general risk scores are rather low, more detailed analyses show that teenagers nevertheless post a significant amount of risky information. Moreover, older teenagers and girls post more (risky) information while there are no differences in applying privacy settings. We found no differences in the Facebook behavior of teenagers enrolled in different education forms. Implications of these results are discussed. PMID:25162234

  19. How Safe Do Teenagers Behave on Facebook? An Observational Study

    PubMed Central

    Vanderhoven, Ellen; Schellens, Tammy; Valcke, Martin; Raes, Annelies

    2014-01-01

    The substantial use of social network sites by teenagers has raised concerns about privacy and security. Previous research about behavior on social network sites was mostly based on surveys and interviews. Observational research overcomes problems inherent to this research method, for example social desirability. However, existing observational research mostly focuses on public profiles of young adults. Therefore, the current observation-study includes 1050 public and non-public Facebook-profiles of teenagers (13–18) to investigate (1) what kind of information teenagers post on their profile, (2) to what extent they protect this information using privacy-settings and (3) how much risky information they have on their profile. It was found that young people mostly post pictures, interests and some basic personal information on their profile. Some of them manage their privacy-settings as such that this information is reserved for friends' eyes only, but a lot of information is accessible on the friends-of-friends' pages. Although general risk scores are rather low, more detailed analyses show that teenagers nevertheless post a significant amount of risky information. Moreover, older teenagers and girls post more (risky) information while there are no differences in applying privacy settings. We found no differences in the Facebook behavior of teenagers enrolled in different education forms. Implications of these results are discussed. PMID:25162234

  20. Palliative care team visits. Qualitative study through participant observation

    PubMed Central

    Bueno Pernias, Maria José; Hueso Montoro, César; Guardia Mancilla, Plácido; Montoya Juárez, Rafael; García Caro, Maria Paz

    2016-01-01

    Objectives: To describe the clinical encounters that occur when a palliative care team provides patient care and the features that influence these encounters and indicate whether they are favorable or unfavorable depending on the expectations and feelings of the various participants. Methods: A qualitative case study conducted via participant observation. A total of 12 observations of the meetings of palliative care teams with patients and families in different settings (home, hospital and consultation room) were performed. The visits were follow-up or first visits, either scheduled or on demand. Content analysis of the observation was performed. Results: The analysis showed the normal follow-up activity of the palliative care unit that was focused on controlling symptoms, sharing information and providing advice on therapeutic regimens and care. The environment appeared to condition the patients' expressions and the type of patient relationship. Favorable clinical encounter conditions included kindness and gratitude. Unfavorable conditions were deterioration caused by approaching death, unrealistic family objectives and limited resources. Conclusion: Home visits from basic palliative care teams play an important role in patient and family well-being. The visits seem to focus on controlling symptoms and are conditioned by available resources. PMID:27226663

  1. Study of a microflare observed with SUMER and TRACE

    NASA Astrophysics Data System (ADS)

    Gontikakis, C.; Winebarger, A. R.

    2012-01-01

    We study a GOES-A1 microflare, observed in active region NOAA 8541 on May 15, 1999 with TRACE images, SUMER spectra and MDI magnetograms. In TRACE filtergrams of 171A and 195A, the microflare is composed of two interacting, 20Mm long, loops. SUMER observations include four spectral lines: the Si II 1533A (a chromospheric line), the C IV 1548A, 1550 A (transition region lines) and the Ne VIII 770 A (a coronal line). These spectra record the impulsive stage of the microflare, which appears as a bright feature at the west footpoint of the TRACE loops. In an area adjacent to the microflare we observe, for the first time on the solar disk, a region where the lines intensity ratio 1548A/1550A equals to 4 which means that resonant scattering dominates the emission process. Over the microflare, the SUMER spectral lines are blue shifted, indicating upflows due to explosive evaporation, as well as red shifted, indicating, cooling downward motions. Moreover, the C IV microflare spectral profiles, indicate upflows of ~200 km/s even if most of them are damaged due to the SUMER detector over exposure, while the Si II 1533A profiles are self-reversed due to opacity effects.

  2. Improving safety climate through a communication and recognition program for construction: a mixed-methods study

    PubMed Central

    Sparer, Emily H; Catalano, Paul J; Herrick, Robert F; Dennerlein, Jack T

    2016-01-01

    Objectives This study aimed to evaluate the efficacy of a safety communication and recognition program (B-SAFE), designed to encourage improvement of physical working conditions and hazard reduction in construction. Methods A matched pair cluster randomized controlled trial was conducted on eight worksites (four received the B-SAFE intervention, four served as control sites) for approximately five months per site. Pre- and post-exposure worker surveys were collected at all sites (N=615, pre-exposure response rate of 74%, post-exposure response rate of 88%). Multi-level mixed-effect regression models evaluated the effect of B-SAFE on safety climate as assessed from surveys. Focus groups (N=6–8 workers/site) were conducted following data collection. Transcripts were coded and analyzed for thematic content using Atlas.ti (version 6). Results The mean safety climate score at intervention sites, as measured on a 0–50 point scale, increased 0.5 points (1%) between pre- and post-B-SAFE exposure, compared to control sites that decreased 0.8 points (1.6%). The intervention effect size was 1.64 (3.28%) (P-value=0.01) when adjusted for month the worker started on-site, total length of time on-site, as well as individual characteristics (trade, title, age, and race/ethnicity). At intervention sites, workers noted increased levels of safety awareness, communication, and teamwork compared to control sites. Conclusions B-SAFE led to many positive changes, including an improvement in safety climate, awareness, teambuilding, and communication. B-SAFE was a simple intervention that engaged workers through effective communication infrastructures and had a significant, positive effect on worksite safety. PMID:27158914

  3. Pandemrix™ and narcolepsy: A critical appraisal of the observational studies.

    PubMed

    Verstraeten, Thomas; Cohet, Catherine; Dos Santos, Gaël; Ferreira, Germano Lc; Bollaerts, Kaatje; Bauchau, Vincent; Shinde, Vivek

    2016-01-01

    A link between Pandemrix™ (AS03-adjuvanted H1N1 pandemic influenza vaccine, GSK Vaccines, Belgium) and narcolepsy was first suspected in 2010 in Sweden and Finland following a number of reports in children and adolescents. Initial scepticism about the reported association faded as additional countries reported similar findings, leading several regulatory authorities to restrict the use of Pandemrix™. The authors acknowledge that currently available data suggest an increased risk of narcolepsy following vaccination with Pandemrix™; however, from an epidemiologist's perspective, significant methodological limitations of the studies have not been fully addressed and raise questions about the reported risk estimates. We review the most important biases and confounders that potentially occurred in 12 European studies of the observed association between Pandemrix™ and narcolepsy, and call for further analyses and debate. PMID:26379011

  4. Spacelab Science Results Study. Volume 1; External Observations

    NASA Technical Reports Server (NTRS)

    Naumann, Robert J. (Compiler)

    1999-01-01

    Some of the 36 Spacelab missions were more or less dedicated to specific scientific disciplines, while other carried a eclectic mixture of experiments ranging from astrophysics to life sciences. However, the experiments can be logically classified into two general categories; those that make use of the Shuttle as an observing platform for external phenomena (including those which use the Shuttle in an interactive mode) and those which use the Shuttle as a microgravity laboratory. This first volume of this Spacelab Science Results study will be devoted to experiments of the first category. The disciplines included are Astrophysics, Solar Physics, Space Plasma Physics, Atmospheric Sciences, and Earth Sciences. Because of the large number of microgravity investigations, Volume 2 will be devoted to Microgravity Sciences, which includes Fluid Physics, Combustion Science, Materials Science, and Biotechnology, and Volume 3 will be devoted to Space Life Sciences, which studies the response and adaptability of living organisms to the microgravity environment.

  5. Safety of Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12-supplemented yogurt in healthy adults on antibiotics: a phase I safety study

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Probiotics are live microorganisms that, when administered in sufficient doses, provide health benefits on the host. The United States Food and Drug Administration (FDA) requires phase I safety studies for probiotics when the intended use of the product is as a drug. The purpose of the study was to ...

  6. An observational study of entrainment rate in deep convection

    SciTech Connect

    Guo, Xiaohao; Lu, Chunsong; Zhao, Tianliang; Zhang, Guang Jun; Liu, Yangang

    2015-09-22

    This study estimates entrainment rate and investigates its relationships with cloud properties in 156 deep convective clouds based on in-situ aircraft observations during the TOGA-COARE (Tropical Ocean Global Atmosphere Coupled Ocean Atmosphere Response Experiment) field campaign over the western Pacific. To the authors’ knowledge, this is the first study on the probability density function of entrainment rate, the relationships between entrainment rate and cloud microphysics, and the effects of dry air sources on the calculated entrainment rate in deep convection from an observational perspective. Results show that the probability density function of entrainment rate can be well fitted by lognormal, gamma or Weibull distribution, with coefficients of determination being 0.82, 0.85 and 0.80, respectively. Entrainment tends to reduce temperature, water vapor content and moist static energy in cloud due to evaporative cooling and dilution. Inspection of the relationships between entrainment rate and microphysical properties reveals a negative correlation between volume-mean radius and entrainment rate, suggesting the potential dominance of homogeneous mechanism in the clouds examined. The entrainment rate and environmental water vapor content show similar tendencies of variation with the distance of the assumed environmental air to the cloud edges. Their variation tendencies are non-monotonic due to the relatively short distance between adjacent clouds.

  7. An observational study of entrainment rate in deep convection

    DOE PAGESBeta

    Guo, Xiaohao; Lu, Chunsong; Zhao, Tianliang; Zhang, Guang Jun; Liu, Yangang

    2015-09-22

    This study estimates entrainment rate and investigates its relationships with cloud properties in 156 deep convective clouds based on in-situ aircraft observations during the TOGA-COARE (Tropical Ocean Global Atmosphere Coupled Ocean Atmosphere Response Experiment) field campaign over the western Pacific. To the authors’ knowledge, this is the first study on the probability density function of entrainment rate, the relationships between entrainment rate and cloud microphysics, and the effects of dry air sources on the calculated entrainment rate in deep convection from an observational perspective. Results show that the probability density function of entrainment rate can be well fitted by lognormal,more » gamma or Weibull distribution, with coefficients of determination being 0.82, 0.85 and 0.80, respectively. Entrainment tends to reduce temperature, water vapor content and moist static energy in cloud due to evaporative cooling and dilution. Inspection of the relationships between entrainment rate and microphysical properties reveals a negative correlation between volume-mean radius and entrainment rate, suggesting the potential dominance of homogeneous mechanism in the clouds examined. The entrainment rate and environmental water vapor content show similar tendencies of variation with the distance of the assumed environmental air to the cloud edges. Their variation tendencies are non-monotonic due to the relatively short distance between adjacent clouds.« less

  8. Rotational Spectroscopic Studies and Observational Searches for HO3

    NASA Astrophysics Data System (ADS)

    Widicus Weaver, Susanna

    Interstellar chemistry is largely driven by reactions of unstable molecules that serve as reaction intermediates in terrestrial chemistry. One such class of compounds are weakly-bound clusters. These clusters could form in interstellar environments through radiative association reactions, but their identification and characterization in interstellar environments is limited by a lack of rotational spectral information. One such species is HO3, which could be formed in the interstellar medium from O2 and OH. HO3 has been studied extensively in the infrared, and there are a few microwave spectral studies that have also been reported. However, no millimeter or submillimeter spectral information is available to guide astronomical observations. In this talk, we will present the laboratory characterization of trans -HO3 and trans -DO3 from 70 to 450 GHz using our newly developed fast sweeping technique. The molecular constants have been significantly refined, and additional higher order centrifugal distortion constants have been determined. We will also present an initial observational search for HO3 in 32 star forming regions. Although no HO3 lines have been detected thus far, strict upper limits can be placed on the HO3 column density in these sources based on this analysis. Additional Authors: Luyao Zou, Brian M. Hays.

  9. Review of accidental safety studies for the European HCPB test blanket system

    NASA Astrophysics Data System (ADS)

    Boccaccini, L. V.; Ciattaglia, S.; Meyder, R.; Jin, X.

    2007-07-01

    This paper presents a review of safety studies for accidental sequences in the European solid breeder test blanket module (TBM) system. These studies are the starting point for the Preliminary Safety Analysis Report of ITER, under preparation to get the construction permit first and then later the operation licence. In general the reduced inventory of activation products and tritium associated with the TBM system makes the impact of this test system almost negligible on the overall safety risk of ITER. Nevertheless, the possibility of jeopardizing the ITER safety concept has been analysed in connection to the consequences of specific accident sequences, e.g. the pressurization of the vacuum vessel due to the He coolant blow-down, the hydrogen production from the Be-steam reaction, the possible interconnection between the port cell and the vacuum vessel causing air ingress and the necessity to assure heat removal in the short and long periods. In the frame of this assessment, three LOCA sequences have been selected as representative of accidents judged to cover all scenarios envisaged in Cat II to IV events involving the TBM, namely, in-vessel LOCA, ex-vessel LOCA and in-box LOCA.

  10. Risk decision making in operational safety management - experience from the Nordic benchmark study

    SciTech Connect

    Holmberg, J.; Pulkkinen, U. ); Poern, K. ); Shen, K. )

    1994-12-01

    Technical Research Centre of Finland (VTT) and Studsvik AB, Sweden, have simulated decision making of the Swedish Nuclear Power Inspectorate and a power company by applying decision models in a benchmark study. Based on the experience from the benchmark study, a decision analysis framework to be used in safety related problems is outlined. By this framework both the power companies and the safety authorities could be provided with a more rigorous, systematic approach in their decision making. A decision analytic approach provides a structure for identifying the information requirements of the problem solving. Thus it could serve as a discussion forum between the authorities and the utilities. In this context, probabilistic safety assessment (PSA) has a crucial role of expressing the plant safety status in terms of reactor core damage accident probability and of risk contributions from various accident precursors. However, a decision under uncertainty should not be based solely on probabilities, particularly when the event in question is a rare one and its probability of occurrence is estimated by means of different kinds of approximations. 26 refs., 4 figs., 4 tabs.

  11. Food safety knowledge, attitudes and practices of mothers: findings from focus group studies in South India.

    PubMed

    Subba Rao, G M; Sudershan, R V; Rao, Pratima; Vishnu Vardhana Rao, M; Polasa, Kalpagam

    2007-09-01

    In India, most of the diarrhoeal deaths among children (<5 years) are attributed to food and water contamination. Mothers are usually the final line of defence against food borne illnesses. Thus, the role of mothers in ensuring food safety at homes is well accepted. There are hardly any studies in India to understand their knowledge, attitudes and practices on food safety. The present study was an attempt in this direction. A total of 32 Focus Group Discussions were carried out with mothers of children <5 years in 16 districts from all the four South Indian states. The findings reveal that food safety awareness and practices are good among mothers perhaps due to the Indian food ethos passed on to them through generations. Home cooked foods are considered to be safer than prepared foods bought from outside. Many mothers were aware of the common food adulterants but do not bother to complain or take action. There is a need to create enabling environment with improved access to potable water, sanitation and cooking fuel. Spreading awareness about checking food labels and reporting to the health authorities in case of food poisoning or adulteration is also the need of the hour. The Anganwadi Centres can be the focal points for imparting food safety education to the mothers. PMID:17448570

  12. Computational and Observational Studies of Interstellar Thioformaldehyde Masers

    NASA Astrophysics Data System (ADS)

    Simpson, Lisa; Hoffman, I. M.

    2013-06-01

    Interstellar spectroscopy of thioformaldehyde (H2CS) holds considerable promise because of the close relationship between the H2CS molecule and the well-studied formaldehyde (H2CO) molecule. In particular, the well-known J(Ka,Kc) = 1(1,0) to 1(1,1) transition of H2CO at 6 cm (4.8 GHz) has an analogous H2CS transition at 1046 MHz. However, the 1046-MHz line of H2CS has never been detected astronomically. We present here a summary of: (1) a computational investigation of H2CS level populations related to known H2CO 6-cm masers, and (2) an observational campaign of four isotopologues of H2CS. Maser emission from H2CO has been observed at 6 cm for which Boland and de Jong (1981) have developed a pump model. We have extended this model to H2CS and we present preliminary calculations for a 1046-MHz maser. We intend to develop a quantitative tool for interpreting H2CS observations toward Galactic and extragalactic locations of H2CO maser emission by constructing a radiative-transfer maser model for H2CS. Thioformaldehyde has been detected in a few Galactic sources via J>1 transitions. However, interpretation of these results has two outstanding problems: the H2CS/H2CO abundances do not agree with known sulfur-to-oxygen ratios nor do the J>1 populations have the expected Boltzmann relationship to the J=1 states. A detection of the 1046-MHz transition of H2CS with J=1 would alleviate many of the ambiguities in the interpretation of existing observational results. We describe our forthcoming experiment to search in a Galactic star-forming region for thermal and nonthermal emission and absorption from four thioformaldehyde isotopologues: H2(12C)(32S), H2(13C)(32S), H2(12C)(34S), and D2(12C)(32S). Taken together, both parts of this research effort will provide valuable and novel constraints on H2CS and H2CO. New observations of H2CS isotopologues will yield new measurements of deuterium-to-hydrogen and sulfur-to-oxygen ratios in star-forming environments. Also, the application

  13. OBSERVATIONAL STUDY OF THE MULTISTRUCTURED PLANETARY NEBULA NGC 7354

    SciTech Connect

    Contreras, M. E.; Vazquez, R.; Miranda, L. F.; Zavala, S.; Ayala, S. E-mail: vazquez@astrosen.unam.mx E-mail: lorenzo@astro.uson.mx E-mail: sayala@ideabc.org

    2010-04-15

    We present an observational study of the planetary nebula (PN) NGC 7354 consisting of narrowband H{alpha} and [N II]{lambda}6584 imaging as well as low- and high-dispersion long-slit spectroscopy, and VLA-D radio continuum. According to our imaging and spectroscopic data, NGC 7354 has four main structures: a quite round outer shell and an elliptical inner shell, a collection of low-excitation bright knots roughly concentrated on the equatorial region of the nebula, and two asymmetrical jet-like features, not aligned either with the shells' axes, or with each other. We have obtained physical parameters like electron temperature and electron density as well as ionic and elemental abundances for these different structures. Electron temperature and electron density slightly vary throughout the nebula going from {approx_equal}11, 000 to {approx_equal}14, 000 K, and from {approx_equal}1000 to {approx_equal} 3000 cm{sup -3}, respectively. The local extinction coefficient c {sub H{beta}} shows an increasing gradient from south to north and a decreasing gradient from east to west consistent with the number of equatorial bright knots present in each direction. Abundance values show slight internal variations but most of them are within the estimated uncertainties. In general, abundance values are in good agreement with the ones expected for PNe. Radio continuum data are consistent with optically thin thermal emission. Mean physical parameters derived from the radio emission are electron density n{sub e} = 710 cm{sup -3} and M(H II) = 0.22 M {sub sun}. We have used the interactive three-dimensional modeling tool SHAPE to reproduce the observed morphokinematic structures in NGC 7354 with different geometrical components. Our observations and model show evidence that the outer shell is moving faster ({approx_equal}35 km s{sup -1}) than the inner one ({approx_equal} 30 km s{sup -1}). Our SHAPE model includes several small spheres placed on the outer shell wall to reproduce

  14. Safety and efficacy of Qurse-e-istisqua in chronic hepatitis C Infection: An exploratory study

    PubMed Central

    Rehan, Harmeet Singh; Chopra, Deepti; Yadav, Madhur; Wardhan, Neeta; Manak, Seema; Siddiqui, KM; Aslam, Mohd.

    2015-01-01

    Background: Qurse-e-istisqua (Q-e-I), an Unani medicine commonly prescribed to treat liver disorders. Objectives: To study efficacy and safety of Q-e-I in hepatitis C virus (HCV) infection. Methods: In this randomized double-blind exploratory study, 60 naive patients of HCV infection were assigned to receive either interferonα2a (IFNα2a) (3 mIU, subcutaneous, thrice weekly), ribavirin (RBV) (1000 mg, orally, twice daily in divided doses) and placebo (n = 30) or IFNα2a, RBV and Q-e-I (5 g, orally, thrice daily in divided doses) (n = 30). HCV RNA levels, serum hyaluronic acid (SHA), ultrasound image scoring for fibrosis, liver and renal function test, prothrombin time, were done at the baseline and thereafter periodically. Results: Early virologic response (EVR), end of treatment response (ETR) and sustained virologic response (SVR) were 90%, 96.6% and 90% in the control group and 86.6%, 90.0% and 83.3% in the treatment group. SHA level was lower in the treatment group at the end of the treatment as compared to the control group. Mean end of follow-up ultrasound image scoring for fibrosis in the control and the treatment group was 1.37 ± 0.07 and 1.22 ± 0.06 respectively. Aspartate aminotransferase (AST) levels were significantly lower in the treatment group than the control group at 1-month. Commonly observed adverse drug reactions included fever, hair fall, fatigue, anemia, and diarrhea. Conclusion: Q-e-I was well tolerated and showed anti-fibrotic activity. EVR, ETR and SVR suggested that Q-e-I do not have any anti-HCV activity. Early recovery in AST and inhibition of progress of fibrosis in Q-e-I group was probably due to the anti-inflammatory and antioxidant activity of its ingredients. PMID:25821315

  15. RGTA-based matrix therapy in severe experimental corneal lesions: safety and efficacy studies.

    PubMed

    Brignole-Baudouin, F; Warnet, J M; Barritault, D; Baudouin, C

    2013-11-01

    Corneal alteration potentially leading to ulceration remains a major health concern in ocular surface diseases. A treatment that would improve both the quality and speed of healing and control the inflammation would be of great interest. Regenerating agents (RGTAs) have been shown to stimulate wound healing and modulate undesired fibrosis in various in vivo systems. We investigated the effects of RGTA-OTR4120(®) in a rabbit corneal model in order to assess its potential use in ocular surface diseases. First, we assessed its safety for 7 and 28 days using the Draize test criteria in healthy rabbit eyes; then, we investigated the effect of a single dose (50μl, 5μg) in an alkali-burned cornea model. Daily follow-up of clinical signs of healing was scored, and histology was performed at D7. RGTA was well tolerated; no signs of ocular irritation were observed. In the corneal alkali-burn model, non-RGTA-treated eyes showed inflammatory clinical signs, and histology confirmed a loss of superficial corneal layers with epithelial disorganization, neovascularization and infiltration of inflammatory cells. When compared to NaCl control, RGTA treatment appeared effective in reducing clinical signs of inflammation, enhancing re-epithelialization, and improving histological patterns: edema, fibrosis, neovascularization and inflammation. Three to four layers of epithelial cells were already organized, stroma was virtually unvascularized and keratocytes well implanted in parallel collagen fibers with an overall reorganization similar to normal cornea. RGTA appears to be a promising agent for controlling ocular surface inflammation and promoting corneal healing and was well tolerated. This study offers preclinical information and supports the findings of other (compassionate or pilot) studies conducted in patients with various ocular surface diseases. PMID:23958066

  16. Efficacy and safety of tacrolimus compared with ciclosporin-A in renal transplantation: 7-year observational results.

    PubMed

    Krämer, Bernhard K; Montagnino, Giuseppe; Krüger, Bernd; Margreiter, Raimund; Olbricht, Christoph J; Marcen, Roberto; Sester, Urban; Kunzendorf, Ulrich; Dietl, Karl-Heinz; Rigotti, Paolo; Ronco, Claudio; Hörsch, Silke; Banas, Bernhard; Mühlbacher, Ferdinand; Arias, Manuel

    2016-03-01

    The European Tacrolimus versus Ciclosporin-A Microemulsion (CsA-ME) Renal Transplantation Study demonstrated that tacrolimus decreased acute rejection rates at 6 months. Primary endpoints of this investigator-initiated, observational 7-year follow-up study were acute rejection rates, patient and graft survival rates, and a composite endpoint (BPAR, graft loss, and patient death). We analyzed data from the original intent-to-treat population (n = 557; 286 tacrolimus, 271 CsA-ME). A total of 237 tacrolimus and 208 CsA-ME patients provided data. At 7 years, Kaplan-Meier estimated rates of patients free from BPAR were 77.1% in the tacrolimus arm and 59.9% in the CsA-ME arm, graft survival rates amounted to 82.6% and 80.6%, and patient survival rates to 89.9% and 88.1%. Estimated combined endpoint-free survival rates were 60.2% in the tacrolimus arm and 47.0% in the CsA-ME arm (P = <0.0001). A higher number of patients from the CsA-ME arm crossed over to tacrolimus during 7 year follow-up: 19.7% vs. 7.9% (P = <0.002). More patients in the tacrolimus group stopped steroids and received immunosuppressive monotherapy. Significantly, more CsA-ME patients received lipid-lowering medication and experienced cosmetic and cardiovascular adverse events. Tacrolimus-treated renal transplant recipients had significantly higher combined endpoint-free survival rates mainly driven by lower acute rejection rates despite less immunosuppressive medication at 7 years. PMID:26565071

  17. Strengthening leadership as a catalyst for enhanced patient safety culture: a repeated cross-sectional experimental study

    PubMed Central

    Kristensen, Solvejg; Christensen, Karl Bang; Jaquet, Annette; Møller Beck, Carsten; Sabroe, Svend; Bartels, Paul; Mainz, Jan

    2016-01-01

    Objectives Current literature emphasises that clinical leaders are in a position to enable a culture of safety, and that the safety culture is a performance mediator with the potential to influence patient outcomes. This paper aims to investigate staff's perceptions of patient safety culture in a Danish psychiatric department before and after a leadership intervention. Methods A repeated cross-sectional experimental study by design was applied. In 2 surveys, healthcare staff were asked about their perceptions of the patient safety culture using the 7 patient safety culture dimensions in the Safety Attitudes Questionnaire. To broaden knowledge and strengthen leadership skills, a multicomponent programme consisting of academic input, exercises, reflections and discussions, networking, and action learning was implemented among the clinical area level leaders. Results In total, 358 and 325 staff members participated before and after the intervention, respectively. 19 of the staff members were clinical area level leaders. In both surveys, the response rate was >75%. The proportion of frontline staff with positive attitudes improved by ≥5% for 5 of the 7 patient safety culture dimensions over time. 6 patient safety culture dimensions became more positive (increase in mean) (p<0.05). Frontline staff became more positive on all dimensions except stress recognition (p<0.05). For the leaders, the opposite was the case (p<0.05). Staff leaving the department after the first measurement had rated job satisfaction lower than the staff staying on (p<0.05). Conclusions The improvements documented in the patient safety culture are remarkable, and imply that strengthening the leadership can act as a significant catalyst for patient safety culture improvement. Further studies using a longitudinal study design are recommended to investigate the mechanism behind leadership's influence on patient safety culture, sustainability of improvements over time, and the association of change

  18. High salt meals in staff canteens of salt policy makers: observational study

    PubMed Central

    Berentzen, C A; van Montfrans, G A

    2011-01-01

    Objective To assess the salt content of hot meals served at the institutions of salt policy makers in the Netherlands. Design Observational study. Setting 18 canteens at the Department of Health, the Health Council, the Food and Consumer Product Safety Authority, university hospitals, and affiliated non-university hospitals. Intervention A standard hot meal collected from the institutional staff canteens on three random days. Main outcome measure Salt content of the meals measured with an ion selective electrode assay. Results The mean salt content of the meals (7.1 g, SE 0.2 g) exceeded the total daily recommended salt intake of 6 g and was high at all locations: 6.9 g (0.4 g) at the Department of Health and National Health Council; 6.0 g (0.9 g) at the Food and Consumer Product Safety Authority; 7.4 g (0.5 g) at university hospital staff canteens; and 7.0 g (0.3 g) at non-university hospital staff canteens. With data from a national food consumption survey, the estimated total mean daily salt intake in people who ate these meals was 15.4 g. This translates into a 23-36% increase in premature cardiovascular mortality compared with people who adhere to the recommended levels of salt intake. Conclusion If salt policy makers eat at their institutional canteens they might consume too much salt, which could put their health at risk. PMID:22187322

  19. Mucocutaneous manifestations of acquired hypoparathyroidism: An observational study.

    PubMed

    Sarkar, Somenath; Mondal, Modhuchanda; Das, Kapildev; Shrimal, Arpit

    2012-09-01

    Hypoparathyroidism is a disorder of calcium and phosphorus metabolism due to decreased secretion of parathyroid hormone. Hypoparathyroidism can be hereditary and acquired. Acquired hypoparathyroidism usually occurs following neck surgery (thyroid surgery or parathyroid surgery). Along with systemic manifestations, hypoparathyroidism produces some skin manifestations. Lack of study regarding mucocutaneous manifestations of acquired hypoparathyroidism prompted us to undertake this study. To evaluate the mucocutaneous manifestations of acquired hypoparathyroidism. An observational study done in a tertiary care hospital of Kolkata by comprehensive history taking, through clinical examination and relevant laboratory investigations. Twenty-one patients were included in the study. The commonest form of acquired hypoparathyroidism was neck surgery (thyroidectomy and parathyroidectomy operation). Mucocutaneous manifestations were present in 76.19% of patients. The most frequent mucocutaneous manifestation was found in the hairs like the loss of axillary hair (61.9%), loss of pubic hair (52.38%), coarsening of body hair (47.62%), and alopecia areata (9.52%). The nail changes noted were brittle and ridged nail, followed by onycholysis, onychosezia, and onychomedesis. The most common skin features were xerotic skin in 11 patients (52.38%), followed by pellagra-like skin pigmentation, pustular psoriasis and acne form eruption, bullous impetigo, etc. Mucosa was normal in all the cases excepting the one which showed oral candidiasis. PMID:23087872

  20. [Economic assessment, a field between clinical research and observational studies].

    PubMed

    Launois, Robert

    2003-01-01

    Health technology assessments propose to study the differential impact of health interventions in a complex care system which is characterised by the multitude of individual behaviours and the diverse nature of the institutions involved. Current systems for data collection lend themselves poorly to this rigorous analysis of efficacy of treatments in the actual situations where they are used. Randomised trials endeavour to neutralise any parasitic interference which could compromise testing for a causal relationship between the treatment administered and the result obtained. Their methodology which establishes the term ceteris paribus in the principle of good practice lends itself poorly to an analysis of individual behaviour. Observational studies are start from actual treatment situations to describe them as reliably as possible. By definition, however, these assume that the natural course of events is not deviated by any intervention. The absence of an experimental plan increases the likelihood of bias and makes it more difficult to test for causal relationships. They lend themselves poorly to testing for incremental efficacy. The two instruments to be preferred are decisional analysis and quasi-experimental studies. Decisional analysis help to avoid the problems of external validity associated with randomised clinical trials by associating parameters which are extracted from data obtained from everyday practice. Quasi-experimental studies or pragmatic trials are based on the reality of behaviour of the prescriber and his/her patients; their impact on efficacy, quality of life social costs of the disease and of treatments may be identified under normal conditions of use. PMID:12609811

  1. Safety assessment in plant layout design using indexing approach: implementing inherent safety perspective. Part 2-Domino Hazard Index and case study.

    PubMed

    Tugnoli, Alessandro; Khan, Faisal; Amyotte, Paul; Cozzani, Valerio

    2008-12-15

    The design of layout plans requires adequate assessment tools for the quantification of safety performance. The general focus of the present work is to introduce an inherent safety perspective at different points of the layout design process. In particular, index approaches for safety assessment and decision-making in the early stages of layout design are developed and discussed in this two-part contribution. Part 1 (accompanying paper) of the current work presents an integrated index approach for safety assessment of early plant layout. In the present paper (Part 2), an index for evaluation of the hazard related to the potential of domino effects is developed. The index considers the actual consequences of possible escalation scenarios and scores or ranks the subsequent accident propagation potential. The effects of inherent and passive protection measures are also assessed. The result is a rapid quantification of domino hazard potential that can provide substantial support for choices in the early stages of layout design. Additionally, a case study concerning selection among various layout options is presented and analyzed. The case study demonstrates the use and applicability of the indices developed in both parts of the current work and highlights the value of introducing inherent safety features early in layout design. PMID:18406517

  2. Simulation Study Of Early Afterglows Observed With Swift

    NASA Astrophysics Data System (ADS)

    Nishikawa, Ken-Ichi; Hededal, C.; Hardee, P.; Mizuno, Y.; Fishman, G. J.

    2006-09-01

    A 3-D relativistic particle-in-cell code has been used to simulate the dynamics of forward and reverse shocks with thin and thick shells within the parameter constraints provided by present Swift observations and the present models of GRB emission. Our 3-D RPIC simulations have provided the dynamics of collisionless shocks in electron-ion and electron-positron plasmas with and without initial ambient magnetic fields and revealed the importance of ``jitter radiation'' with prompt and afterglow spectra due to the inhomogeneous magnetic fields generated by the Weibel instability. It is different from synchrotron radiation, which is usually assumed to be the dominant radiation process. We have investigated gamma-ray burst emissions from prompt, early, and late afterglows considering microscopic processes. Based on our previous investigation of the Weibel instability for each stage of evolution of ejecta propagating in the ISM, we have incorporated the plasma conditions (relativistic jets) with the density and composition of the plasmas, the magnetic field strength ($\\sigma$-values (the ratio of the electromagnetic energy flux to the particle energy flux)) and its direction, and the Lorentz factor for the different stages in prompt and afterglows. Systematic simulation studies of the relativistic collisionless shocks, associated particle acceleration, magnetic field generation and self-consistent radiation provide insight into undetermined issues in prompt and afterglows observed by Swift. Self-consistently calculated lightcurves, spectra, spectral evolutions, and polarization as function of viewing angle will be done to light a shed on recent new observations by Swift, in particular, X-ray flares, early steep decay, and shallow decay.

  3. Health, safety, and environmental management system operation in contracting companies: A case study.

    PubMed

    Nassiri, Parvin; Yarahmadi, Rasoul; Gholami, Pari Shafaei; Hamidi, Abdolamir; Mirkazemi, Roksana

    2016-05-01

    Systematic and cooperative interactions among parent industry and contractors are necessary for a successful health, safety, and environmental management system (HSE-MS). This study was conducted to evaluate the HSE-MS performance in contracting companies in one of the petrochemical industries in Iran during 2013. Managers of parent and contracting companies participated in this study. The data collection forms included 7 elements of an integrated HSE-MS (leadership and commitment; policy and strategic objectives; organization, resources, and documentation; evaluation and risk management; planning; implementation and monitoring; auditing and reviewing). The results showed that mean percentage of the total scores in seven elements of HSE-MS was 85.7% and 87.0% based on self-report and report of parent company, respectively. In conclusion, this study showed that HSE-MS was desirably functioning; however, improvement to ensure health and safety of workers is still required. PMID:26418847

  4. Strategies to reduce safety violations for working from heights in construction companies: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Safety measures should be applied to reduce work-related fatal and non-fatal fall injuries. However, according to the labor inspectorate, more than 80% of Dutch construction sites violate safety regulations for working from heights. To increase compliance with safety regulations, employers and workers have to select, implement and monitor safety measures. To facilitate this behavioral change, stimulating knowledge awareness and personalized feedback are frequently advocated behavior change techniques. For this study, two behavior change strategies have been developed in addition to the announcement of safety inspections by the labor inspectorate. These strategies consist of 1) face-to-face contacts with safety consultants and 2) direct mail with access to internet facilities. The objective of this study is to evaluate the effectiveness of these two strategies on the safety violations for working from heights, the process and the cost measures. Methods/Design This study is a block randomized intervention trial in 27 cities to establish the effects of the face-to-face guidance strategy (N = 9), a direct mailing strategy (N = 9) and a control condition of no guidance (N = 9) on safety violations to record by labor inspectors after three months. A process evaluation for both strategies will be performed to determine program implementation (reach, dose delivered and dose received), satisfaction, knowledge and perceived safety behavior. A cost analysis will be performed to establish the financial costs for both strategies. The present study is in accordance with the CONSORT statement. Discussion This study increases insight into performing practice-based randomized controlled trials. The outcome will help to evaluate the effect of two guidance strategies on safety violations. If these strategies are effective, implementation of these strategies through the national institute of safety and health or labor inspectorate can take place to guide

  5. Providers' response to child eating behaviors: A direct observation study.

    PubMed

    Tovar, Alison; Vaughn, Amber E; Fallon, Megan; Hennessy, Erin; Burney, Regan; Østbye, Truls; Ward, Dianne S

    2016-10-01

    Child care providers play an important role in feeding young children, yet little is known about children's influence on providers' feeding practices. This qualitative study examines provider and child (18 months -4 years) feeding interactions. Trained data collectors observed 200 eating occasions in 48 family child care homes and recorded providers' responses to children's meal and snack time behaviors. Child behaviors initiating provider feeding practices were identified and practices were coded according to higher order constructs identified in a recent feeding practices content map. Analysis examined the most common feeding practices providers used to respond to each child behavior. Providers were predominately female (100%), African-American (75%), and obese (77%) and a third of children were overweight/obese (33%). Commonly observed child behaviors were: verbal and non-verbal refusals, verbal and non-verbal acceptance, being "all done", attempts for praise/attention, and asking for seconds. Children's acceptance of food elicited more autonomy supportive practices vs. coercive controlling. Requests for seconds was the most common behavior, resulting in coercive controlling practices (e.g., insisting child eat certain food or clean plate). Future interventions should train providers on responding to children's behaviors and helping children become more aware of internal satiety and hunger cues. PMID:27328098

  6. Observational study of job satisfaction in hospital pharmacy technicians.

    PubMed

    Sanford, M E; Facchinetti, N J; Broadhead, R S

    1984-12-01

    Intrinsic and extrinsic factors contributing to job satisfaction of pharmacy technicians in two community hospitals were studied. A pharmacy student employed part-time as a pharmacy technician by one of the hospitals observed fellow technicians in a wide range of job activities for 22 months. In a second hospital, the same student conducted similar observations during one summer while posing as a social researcher. Both hospitals had technician training programs providing classroom instruction and on-the-job training. Data were gathered primarily from informal conversations with technicians and pharmacists and by recording activities through notetaking. Formal training programs, praise from pharmacists, opportunities to train other technicians, diversity of job activities, and autonomy in coordinating work with time demands were identified as factors contributing to job satisfaction of technicians. Negative aspects of the job that employers attempted to circumvent or clarify were the unchallenging nature of the work and the limited opportunities for advancement. Technicians' and pharmacists' attitudes toward job enrichment for technicians are discussed, and suggestions for improving technicians' intrinsic and extrinsic job satisfaction are provided. A reliable cadre of pharmacy technicians is necessary for further expansion of clinical pharmacy services under current hospital budgetary restraints. In addition to modifying job activities to promote technicians' intrinsic job satisfaction, pharmacy managers can improve extrinsic satisfaction by providing adequate salaries, job security, and flexible work schedules. PMID:6517083

  7. A study of GPS ionospheric scintillations observed at Guilin

    NASA Astrophysics Data System (ADS)

    Zou, Yuhua; Wang, Dongli

    2009-12-01

    The occurrence of strong ionospheric scintillations with S4>=0.2 was studied using global positioning system (GPS) measurements at Guilin (25.29°N, 110.33°E; geomagnetic: 15.04°N, 181.98°E), a station located near the northern crest of equatorial anomaly in China. The results are presented for data collected from January 2007 to December 2008. The results show that amplitude scintillations occurred only during the first five months of the considered years. Nighttime amplitude scintillations, observed mainly in the south of Guilin, always occurred with phase scintillations, total electron content (TEC) depletions, and Rate Of change of TEC (ROT) fluctuations. However, TEC depletions and ROT fluctuations were weak during daytime amplitude scintillations, and daytime amplitude scintillations usually occurred in most of the azimuth directions. GPS scintillation/TEC observations recorded at Guilin and signal-to-noise-ratio measurements obtained from GPS-COSMIC radio occultation indicate that nighttime and daytime scintillations are very likely caused by ionospheric F region irregularities and sporadic E, respectively.

  8. [Observational study of atmospheric HONO in summer of Beijing].

    PubMed

    Zhu, Yan-Wu; Liu, Wen-Qing; Xie, Pin-Hua; Dou, Ke; Liu, Shi-Sheng; Si, Fu-Qi; Li, Su-Wen; Qin, Min

    2009-06-15

    The concentration of HONO, NO2, O3 and other atmospheric pollutants were observed continuously by using differential optical absorption spectroscopy (DOAS) from 2007-08-14 to 2007-08-24 in Beijing, China. Diurnal variation characteristics of HONO and NO2 were analyzed. The HONO levels originated from the nocturnal direct emission were discussed. And the correlation between the heterogeneous formation of HONO and its related factors (BC, RH, and so on) was studied. The results showed that HONO had two peaks at about 01:00 and 06:00, respectively, while two peaks of NO2 concentrations appeared at about 01:00 and 07:00. The highest HONO(em)/HONO ratio of 31.3% was observed at about 20:00 between 19:00 to 07:00, and the average ratio was 15%. Good correlation of HONO(corr)/NO2 ratio with BC and RH at night was obtained. The correlation suggested that heterogeneous NO2 to HONO conversion processes may occur on BC surfaces by reaction with absorption water, and the average nighttime conversion frequency from NO2 into HONO (HONO/NO2) was calculated about 0.8% x h(-1). At the same time, the results showed that heterogeneous formation of HONO was increased with RH and inhibited at RH > 80%, and the hypothesis was further supported by detailed analysis of selected case. PMID:19662832

  9. Technology Solutions Case Study: Combustion Safety for Appliances Using Indoor Air

    SciTech Connect

    2014-05-01

    This case study describes how to assess and carry out the combustion safety procedures for appliances and heating equipment that uses indoor air for combustion in low-rise residential buildings. Only appliances installed in the living space, or in an area freely communicating with the living space, vented alone or in tandem with another appliance are considered here. This document is for inspectors, auditors, and technicians working in homes where energy upgrades are being conducted whether or not air infiltration control is included in the package of measures being applied. In the indoor combustion air case, guidelines summarized here are based on language provided in several of the codes to establish minimum requirements for the space using simplified prescriptive measures. In addition, building performance testing procedures are provided by testing agencies. The codes in combination with the test procedures offer comprehensive combustion safety coverage to address safety concerns, allowing inexperienced residential energy retrofit inspectors to effectively address combustion safety issues and allow energy retrofits to proceed.

  10. Improving general practice computer systems for patient safety: qualitative study of key stakeholders

    PubMed Central

    Avery, Anthony J; Savelyich, Boki S P; Sheikh, Aziz; Morris, Caroline J; Bowler, Isobel; Teasdale, Sheila

    2007-01-01

    Objective The authors sought to identify ways in which the use of general practice computer systems could be improved to enhance safety in primary care. Design Qualitative study using semistructured interviews. Participants Thirty one participants, representing a broad range of relevant disciplines and interest groups. Participants included clinicians, computer system and drug database suppliers, academics with interests in health informatics and members of governmental, professional and patient representative bodies. Setting UK. Results Participants identified deficiencies in current systems that pose serious threats to patient safety. To bring about improvements, providers need to supply clinicians with safe, accurate and accessible information for decision support; be aware of the importance of human ergonomics in the design of hazard alerts; consider the value of audit trails and develop mechanisms to allow for the accurate transfer of information between clinical computer systems. These improvements in computer systems will be most likely to occur if mandated through regulations. Individual practices are in need of improved education and training which focuses, in particular, on providing support with recording data accurately and using call, recall and reminders effectively. Conclusion There are significant opportunities for improving the safety of general practice computer systems. Priorities include improving the knowledge base for clinical decision support, paying greater attention to human ergonomics in system design, improved staff training and the introduction of new regulations mandating system suppliers to satisfy essential safety requirements. PMID:17301200

  11. Safety of peripheral administration of phenylephrine in a neurologic intensive care unit: A pilot study.

    PubMed

    Delgado, Tim; Wolfe, Brianne; Davis, Gary; Ansari, Safdar

    2016-08-01

    Integral to the management of the neurocritically injured patient are the prevention and treatment of hypotension, maintenance of cerebral perfusion pressure, and occasionally blood pressure augmentation. When adequate volume resuscitation fails to meet perfusion needs, vasopressors are often used to restore end-organ perfusion. This has historically necessitated central venous access given well-documented incidence of extravasation injuries associated with peripheral administration of vasopressors. In this pilot study, we report our 6-month experience with peripheral administration of low-concentration phenylephrine (40 μg/mL) in our neurocritical care unit. We were able to administer peripheral phenylephrine, up to a dose of 2 μg/(kg min), for an average of 14.29hours (1-54.3) in 20 patients with only 1 possible minor complication and no major complications. This was achieved by adding additional safety measures in our computerized physician order entry system and additional nurse-driven safety protocols. Thus, with careful monitoring and safety precautions, peripheral administration of phenylephrine at an optimized concentration appears to have an acceptable safety profile for use in the neurocritical care unit up to a mean infusion time of 14hours. PMID:27288620

  12. Swarm Observations of Field-Aligned Currents: Case Studies

    NASA Astrophysics Data System (ADS)

    Le, G.; Chi, P. J.; Gjerloev, J. W.; Stolle, C.; Luhr, H.; Park, J.; Rauberg, J.

    2014-12-01

    In this paper, we report the results of a few case studies of multi-point magnetic field measurements of field-aligned currents (FACs) from Swarm constellation mission to understand their temporal and spatial characteristics. During the commissioning phase, the three Swarm spacecraft were in an identical polar orbit with a string-of-pearl configuration with small separations. During the science operational phase (since April, 2014), the three spacecraft were placed in slightly different polar orbits: one spacecraft in a higher altitude orbit (507km x 512km) and two side-by-side in lower altitude orbits (459km x 462km). We analyze a few FAC events in both orbital phases and during periods of active geomagnetic conditions. The multi-point observations enable us to examine the FACs' temporal evolution and separate their temporal and spatial variations.

  13. Active region studies with coordinated SOHO, microwave, and magnetograph observations

    NASA Technical Reports Server (NTRS)

    Holman, Gordon D.

    1992-01-01

    The scientific justification for an observing campaign to study the quantitative magnetic and plasma properties of coronal loops in active regions is presented. The SOHO (Solar and Heliospheric Observatory) instruments of primary relevance are CDS (Coronal Diagnostic Spectrometer), EIT, SUMER (Solar Ultraviolet Measurement of Emitted Radiation), and MDI. The primary ground based instruments would be the VLA (Very Large Array), the Owens Valley Radio Observatory, and vector and longitudinal field magnetographs. Similar campaigns have successfully been carried out with the Solar Maximum Mission x-ray polychromator and the Soft X-ray Imaging Sounding Rocket Payload (CoMStOC '87), the Goddard Solar EUV Rocket Telescope and Spectrograph, the Lockheed Solar Plasma Diagnostics Experiment rocket payload, and the Soft X-ray Telescope in Yohkoh (CoMStoc '92). The scientific payoff from such a campaign is discussed in light of the results from these previous campaigns.

  14. Molecular Carbon in the Galaxy: Laboratory and Observational Studies

    NASA Technical Reports Server (NTRS)

    Saykally, Richard James

    2003-01-01

    In a collaboration with the Mats Larsson group from Stockholm, we carried out a new measurement of the rate of dissociative recombination of H(sup *, sub j), using a new pulsed supersonic beam source of rotationally cold H(sup *, sub j). This source was first designed and characterized in our lab by IR cavity ringdown spectroscopy, determining a rotationaYtranslationa1 temperature of 20-60K, depending on conditions. This new source was then taken to Stockholm for the recombination rate studies at the CRYRING storage ring. The recombination rate constant measured against temperature yields values consistent with the most recent calculations, whereas previous experimental measurements varied over a range of 10(exp 4) and were poor agreement with theory. This is a crucial achievement for understanding the ion chemistry of diffuse clouds. Moreover, this result in combination with recent observations implies a greatly enhanced (factor of 40) cosmic ray ionization rate in a diffuse cloud (zeta Persei) relative to previous studies. The implications of this are discussed in our recent Nature paper. An enhanced cosmic-ray flux towards zeta Persei inferred from a laboratory study of the H(sup *, sub j)-e(sup -) recombination rate.

  15. Observational Studies of Pre-Main Sequence Stars

    NASA Astrophysics Data System (ADS)

    Hutchinson, M. G.

    1988-12-01

    This work investigates selected young stars paying particular attention to their photometric and polarimetric characteristics. The stars observed represent particular sub-classes of the Orion Population of young stars: T Tauri stars of about one solar mass (RY Lup, RU Lup, CoD -33o10685 and AK Sco); Herbig Ae/Be stars of a few solar masses (TY CrA, R CrA, T CrA and V856 Sco); a YY Ori star which is thought to be still accreting matter (S CrA); and an 'isolated' T Tauri star which lies away from a star-forming cloud (V4046 Sgr). Data was acquired at ultraviolet, optical and infrared wavelengths, along with optical polarimetric data. The subsequent analysis of data for the well-studied stars can be summarised as follows: the spectroscopic characteristics of the star are defined; possible mechanisms for the photometric variability are discussed; and given the spectral type of the star, the intrinsic flux distribution is determined and the parameters of the optical and infrared emission are thereby determined. The implications of any photometric variability found are also discussed. A possible model of polarisation is discussed and the wavelength dependence of polarisation in eleven young stars is analysed. It is found that the circumstellar environment plays a role in many of the observed characteristics of the stars studied. Several of the stellar spectra show lines which form in a stellar envelope. Each star is found to be affected by circumstellar extinction and to exhibit infrared emission from circumstellar dust. In most cases the circumstellar dust also gives rise to the optical polarisation. The photometric and/or polarimetric variability exhibited by some of the stars is ascribable to changes in the circumstellar dust shell opacity

  16. Studies of Accreting Neutron Stars with RXTE Cycle 4 Observations: II: Too Observations of Transient LMXBs

    NASA Technical Reports Server (NTRS)

    Paciesas, William S.

    2002-01-01

    NASA Grant NAG 5-9045 provided funds for the research project 'TOO Observations of Transient LMxBs' approved under the Rossi X-ray Timing Explorer (RXTE) Guest Observer Program Cycle 4 and funded under the 1999 NASA Astrophysics Data Program. The principal investigator of the observing time proposal was Dr. M. Mendez (U. of Amsterdam). The grant was funded for one year beginning 3/1/2000. The original proposal was submitted by Prof. Jan van Paradijs, who passed away in 1999 before the funds were distributed. Prof. William S. Pauesas administered the grant during the period of performance. In spite of a wealth of observational data on the kHz QPO in low-mass X-ray binaries (LMXBs), the interpretation of this phenomenon is currently uncertain because the pairs of kHz QPO peaks and the oscillations seen in some Type I X-ray bursts are almost, but not quite, connected by a simple beat frequency relation. The proposal was intended to contribute to a solution to this confusion by making RXTE target-of-opportunity observations of two transient LMXBs, Aql X-1 and 4U 1608-52, if the sources became sufficiently bright.

  17. MAGDAS/CPMN Observations for Space Weather Study

    NASA Astrophysics Data System (ADS)

    Yumoto, K.

    2004-05-01

    An objective of the STP (nderline{S}olar nderline{T}errestrial nderline{P}hysics) researches is to support human activities in the geospace in the twenty-first century from an aspect of fundamental study. In order to understand the Sun-Earth system and effects to human lives, the international LWS (nderline{L}iving nderline{W}ith nderline{S}tar) and CAWSES (nderline{C}limate nderline{a}nd nderline{W}eather of nderline{S}un-nderline{E}arth nderline{S}ystem) programs start from 2004. The objective of CAWSES-WG 2 & 3 in Japan for the region from the solar surface through the solar wind, the magnetosphere, the ionosphere, and the thermosphere, to the atmosphere is a creation of new physics; (1) couplings of the complex and composite systems and (2) macro-and-micro-scale couplings in the Solar-Terrestrial system. The goals of CAWSES-WG 2 & 3 in Japan are to construct space weather stations (for observations) and modeling stations (for simulation/empirical modeling) during the period (2004-2008) of the international CAWSES program. Japanese STP groups will coordinate a research network to reach these goals for the space weather study. In order to study the complexity in the solar wind-magnetosphere-ionosphere-Earth's surface system, the nderline{S}pace nderline{E}nvironment nderline{R}esearch nderline{C}enter (SERC), Kyushu University, Fukuoka, Japan will carry out coordinated ground-based network observations for space weather studies, in cooperation with about 30 organizations in the world during the international CAWSES period (2004-2008). In the present paper, we will introduce a real-time nderline{MAC}netic nderline{D}ata nderline{A}cquisition nderline{S}ystem of nderline{C}ircumpan nderline{P}acific nderline{M}agnetometer nderline{N}etwork, i.e. MAGDAS/CPMN system in Kyushu University. By using this system, we will conduct the real-time monitoring and modeling of (1) the global 3-dimensional current system and (2) the plasma density variations for space weather

  18. Therapeutic Immunization In HIV Infected Ugandans Receiving Stable Antiretroviral Treatment: A Phase I Safety Study4

    PubMed Central

    Kityo, Cissy; Bousheri, Stephanie; Akao, Juliette; Ssali, Francis; Byaruhanga, Rose; Ssewanyana, Isaac; Muloma, Prossy; Myalo, Sula; Magala, Rose; Lu, Yichen; Mugyenyi, Peter; Cao, Huyen

    2011-01-01

    Therapeutic immunizations in HIV infection may boost immunity during antiretroviral treatment. We report on the first therapeutic vaccine trial in Uganda, Africa. This open label Phase I trial was designed to assess the safety, tolerability and immunogenicity of a therapeutic HIV-1 vaccine candidate. Thirty HIV positive volunteers receiving a stable regimen of antiretroviral therapy with CD4 counts > 400 were recruited for the safety evaluation of LFn-p24C, a detoxified anthrax-derived polypeptide fused to the subtype C HIV gag protein p24. The vaccine was well tolerated and HIV RNA levels remained undetectable following three immunizations. CD4 counts in vaccine recipients were significantly higher compared to the control individuals after 12 months. HIV-specific responses were associated with higher gain in CD4 counts following LFn-p24C immunizations. Volunteers were subsequently asked to undergo a 30-day period of observed treatment interruption. 8/24 (30%) individuals showed no evidence of viral rebound during treatment interruption. All demonstrated prompt suppression of viral load following resumption of ART. Our data demonstrates the safety of LFn-p24C and suggests that adjunct therapeutic immunization may benefit select individuals in further boosting an immune response. PMID:21211581

  19. Yttrium-90 Radioembolization for Unresectable Standard-chemorefractory Intrahepatic Cholangiocarcinoma: Survival, Efficacy, and Safety Study

    SciTech Connect

    Rafi, Shoaib; Piduru, Sarat M.; El-Rayes, Bassel; Kauh, John S.; Kooby, David A.; Sarmiento, Juan M.; Kim, Hyun S.

    2013-04-15

    To assess the overall survival, efficacy, and safety of radioembolization with yttrium-90 (Y90) for unresectable standard-chemorefractory intrahepatic cholangiocarcinoma (ICC). Patients with unresectable standard-chemorefractory ICC treated with Y90 were studied. Survival was calculated from the date of first Y90 procedure. Tumor response was assessed with the Response Evaluation Criteria in Solid Tumors criteria on follow-up computed tomography or magnetic resonance imaging scans. National Cancer Institute Common Terminology Criteria (NCI CTCAE), version 3, were used for complications. Statistical analysis was performed by the Kaplan-Meier estimator by the log rank test. Nineteen patients underwent a total of 24 resin-based Y90 treatments. Median survival from the time of diagnosis and first Y90 procedure was 752 {+-} 193 [95 % confidence interval (CI) 374-1130] and 345 {+-} 128 (95 % CI 95-595) days, respectively. Median survival with Eastern Cooperative Oncology Group (ECOG) performance status 1 (n = 15) and ECOG performance status 2 (n = 4) was 450 {+-} 190 (95 % CI 78-822) and 345 {+-} 227 (95 % CI 0-790) days, respectively (p = .214). Patients with extrahepatic metastasis (n = 11) had a median survival of 404 {+-} 309 (95 % CI 0-1010) days versus 345 {+-} 117 (95 % CI 115-575) days for patients without metastasis (n = 8) (p = .491). No mortality was reported within 30 days from first Y90 radioembolization. One patient developed grade 3 thrombocytopenia as assessed by NCI CTCAE. Fatigue and transient abdominal pain were observed in 4 (21 %) and 6 (32 %) patients, respectively. Y90 radioembolization is effective for unresectable standard-chemorefractory ICC.

  20. Integration of Active and Passive Safety Technologies--A Method to Study and Estimate Field Capability.

    PubMed

    Hu, Jingwen; Flannagan, Carol A; Bao, Shan; McCoy, Robert W; Siasoco, Kevin M; Barbat, Saeed

    2015-11-01

    The objective of this study is to develop a method that uses a combination of field data analysis, naturalistic driving data analysis, and computational simulations to explore the potential injury reduction capabilities of integrating passive and active safety systems in frontal impact conditions. For the purposes of this study, the active safety system is actually a driver assist (DA) feature that has the potential to reduce delta-V prior to a crash, in frontal or other crash scenarios. A field data analysis was first conducted to estimate the delta-V distribution change based on an assumption of 20% crash avoidance resulting from a pre-crash braking DA feature. Analysis of changes in driver head location during 470 hard braking events in a naturalistic driving study found that drivers' head positions were mostly in the center position before the braking onset, while the percentage of time drivers leaning forward or backward increased significantly after the braking onset. Parametric studies with a total of 4800 MADYMO simulations showed that both delta-V and occupant pre-crash posture had pronounced effects on occupant injury risks and on the optimal restraint designs. By combining the results for the delta-V and head position distribution changes, a weighted average of injury risk reduction of 17% and 48% was predicted by the 50th percentile Anthropomorphic Test Device (ATD) model and human body model, respectively, with the assumption that the restraint system can adapt to the specific delta-V and pre-crash posture. This study demonstrated the potential for further reducing occupant injury risk in frontal crashes by the integration of a passive safety system with a DA feature. Future analyses considering more vehicle models, various crash conditions, and variations of occupant characteristics, such as age, gender, weight, and height, are necessary to further investigate the potential capability of integrating passive and DA or active safety systems. PMID

  1. Evidence of clinical competence by simulation, a hermeneutical observational study.

    PubMed

    Lejonqvist, Gun-Britt; Eriksson, Katie; Meretoja, Riitta

    2016-03-01

    Making the transition from theory to practise easier in nursing education through simulation is widely implemented all over the world, and there is research evidence of the positive effects of simulation. The pre-understanding for this study is based on a definition of clinical competence as encountering, knowing, performing, maturing and developing, and the hypothesis is that these categories should appear in simulated situations. The aim of the study was to explore the forms and expressions of clinical competence in simulated situations and furthermore to explore if and how clinical competence could be developed by simulation. An observational hermeneutic study with a hypothetic-deductive approach was used in 18 simulated situations with 39 bachelor degree nursing students. In the situations, the scenarios, the actors and the plots were described. The story told was "the way from suffering to health" in which three main plots emerged. The first was, doing as performing and knowing, which took the shape of knowing what to do, acting responsibly, using evidence and equipment, appearing confident and feeling comfortable, and sharing work and information with others. The second was, being as encountering the patient, which took the shape of being there for him/her and confirming by listening and answering. The third plot was becoming as maturing and developing which took the shape of learning in co-operation with other students. All the deductive categories, shapes and expressions appeared as dialectic patterns having their negative counterparts. The study showed that clinical competence can be made evident and developed by simulation and that the challenge is in encountering the patient and his/her suffering. PMID:26763209

  2. A phase I safety and pharmacokinetic study of ATX-101: injectable, synthetic deoxycholic acid for submental contouring.

    PubMed

    Walker, Patricia; Fellmann, Jere; Lizzul, Paul F

    2015-03-01

    ATX-101 (deoxycholic acid [DCA] injection) is a proprietary formulation of pure synthetic DCA. When injected into subcutaneous fat, ATX-101 results in focal adipocytolysis, the targeted destruction of fat cells. ATX-101 is undergoing investigation as an injectable drug for contouring the submental area by reducing submental fat (SMF). The purpose of this study was to evaluate the safety and pharmacokinetics (PK) of the maximal therapeutic dose of ATX-101 (100 mg total dose). Following PK evaluation of endogenous DCA, subjects (N=24) received subcutaneous injections of ATX-101 (2 mg/cm2, with or without 0.9% benzyl alcohol) into SMF; PK evaluation was repeated periodically over 24 hours. Endogenous DCA plasma concentrations measured prior to injection were highly variable within and between subjects. Similarly, following ATX-101 injection, DCA plasma concentrations were highly variable, peaked rapidly, and returned to the range observed for endogenous values by 24 hours postdose. All subjects experienced at least 1 adverse event (AE). No death, serious AE, or AE-related discontinuations occurred. The majority of AEs were transient, associated with the area treated, and of mild or moderate severity. No clinically significant changes were reported for laboratory test results, vital signs, or Holter electrocardiograms postdosing. These data support the favorable safety and efficacy observations of ATX-101 as an injectable drug to reduce SMF. PMID:25738850

  3. Nonacog alfa: an analysis of safety data from six prospective clinical studies in different patient populations with haemophilia B treated with different therapeutic modalities.

    PubMed

    Rendo, Pablo; Smith, Lynne; Lee, Hsiao-Yu; Shafer, Frank

    2015-12-01

    Nonacog alfa is a recombinant factor IX (FIX) product indicated for treatment and prevention of bleeding episodes in patients with haemophilia B. This posthoc analysis evaluated the safety of nonacog alfa in key clinical studies across 15 years. Data were pooled from six prospective studies that utilized on-demand, prophylactic and preventive nonacog alfa regimens: three open-label, nonrandomized studies that assessed efficacy and safety; a bioequivalence study of original and reformulated nonacog alfa; an open-label, randomized study that compared on-demand and prophylactic treatment; and a noninterventional observational registry study that evaluated safety. Safety assessments included adverse events, serious adverse events (SAEs) and events of special interest. In total, 412 patients received nonacog alfa treatment. Adverse events occurred in 220 patients (53.4%), the most common being pyrexia (n = 63), nasopharyngitis (n = 53) and cough (n = 52). Forty-eight patients (11.7%) experienced treatment-related adverse events; the most common were hypersensitivity (n = 6), urticaria (n = 6), FIX inhibition (n = 5) and pyrexia (n = 4). Seventy-four patients (18.0%) developed SAEs. Thirty-seven events of special interest occurred in 31 (7.5%) patients. Events of special interest included allergic-type manifestations (n = 15), inhibitor development (n = 5), lack of effect (n = 8), red blood cell agglutination in tubing or syringe (n = 7), and thrombogenicity (n = 2). Six patients (1.5%) withdrew due to seven adverse events: hypersensitivity (n = 3), drug eruption, pruritic rash, urticaria and decreased therapeutic response (n = 1 each). Four patients died during the study; no deaths were related to study medication. This pooled safety analysis in haemophilia B patients confirmed the safety of nonacog alfa across various patient populations. PMID:26196195

  4. 2D vs. 3D mammography observer study

    NASA Astrophysics Data System (ADS)

    Fernandez, James Reza F.; Hovanessian-Larsen, Linda; Liu, Brent

    2011-03-01

    Breast cancer is the most common type of non-skin cancer in women. 2D mammography is a screening tool to aid in the early detection of breast cancer, but has diagnostic limitations of overlapping tissues, especially in dense breasts. 3D mammography has the potential to improve detection outcomes by increasing specificity, and a new 3D screening tool with a 3D display for mammography aims to improve performance and efficiency as compared to 2D mammography. An observer study using a mammography phantom was performed to compare traditional 2D mammography with this ne 3D mammography technique. In comparing 3D and 2D mammography there was no difference in calcification detection, and mass detection was better in 2D as compared to 3D. There was a significant decrease in reading time for masses, calcifications, and normals in 3D compared to 2D, however, as well as more favorable confidence levels in reading normal cases. Given the limitations of the mammography phantom used, however, a clearer picture in comparing 3D and 2D mammography may be better acquired with the incorporation of human studies in the future.

  5. An Observational Study of Pulsations in Proto-Planetary Nebulae

    NASA Astrophysics Data System (ADS)

    Hrivnak, Bruce J.; Lu, Wenxian; Henson, Gary D.; Hillwig, Todd C.

    2016-01-01

    We have been carrying out a long-term monitoring program to study the light variability in proto-planetary nebulae (PPNe). PPNe are post-Asymptotic Giant Branch objects in transition between the AGB and PN phases in the evolution of low and intermediate-mass stars. As such, it is not surprising that they display pulsational variability. We have been carrying out photometric monitoring of 30 of these at the Valparaiso University campus observatory over the last 20 years, with the assistance of undergraduate students. The sample size has been enlarged over the past six years by observations made using telescopes in the SARA consortium at KPNO and CTIO. Periods have been determined for those of F-G spectral types. We have also enlarged the sample with PPNe from outside the Milky Way by determining periods of eight PPNe in the lower metalicity environment of the Magellanic Clouds. Periods for the entire sample range from 35 to 160 days. Some clear patterns have emerged, with those of higher temperature possessing shorter periods and smaller amplitudes, indicating a reduction in period and pulsation amplitude as the objects evolve. Radial velocity monitoring of several of the brightest of these has allowed us to document their changes in brightness, color, and size during a pulsation cycle. The results of this study will be presented. This research is supported by grants from the National Science Foundation (most recently AST 1413660), with additional student support from the Indiana Space Grant Consortium.

  6. Coonhound paralysis. Further clinical studies and electron microscopic observations.

    PubMed

    Cummings, J F; de Lahunta, A; Holmes, D F; Schultz, R D

    1982-01-01

    Prior study of coonhound paralysis (CHP) revealed an acute polyradiculoneuritis in raccoon-hunting dogs with clinical and pathologic features resembling those of Guillain-Barré syndrome (GBS). In the present series of five cases, the clinical features were investigated with emphasis on electrodiagnostic and CSF findings, and pathologic changes were evaluated with both the light and electron microscope. The demonstration of motor nerve conduction delay and CSF albuminocytologic dissociation in affected dogs further supported the clinical similarity of CHP and GBS. As in GBS, affected roots and nerves contained mononuclear cell infiltrates, segmental myelin changes and axon degeneration. Despite these general pathologic similarities, the present study suggested that axon damage was a more consistent finding in CHP than in GBS. In contrast to ultrastructural findings in GBS, the demyelinating process in CHP did not appear dependent upon macrophages for its initiation. Swelling, separation and vesiculation of myelin occurred around axons of reduced diameter often in the absence of proximate macrophages. Macrophages, rather than initiating demyelination, appeared to be superimposed on existing damage. In this regard, the observed changes resembled those reported in galactocerebroside-induced EAN and sera-mediated in vivo demyelination. PMID:7072488

  7. Methodological issues in observational studies and non-randomized controlled trials in oncology in the era of big data.

    PubMed

    Tanaka, Shiro; Tanaka, Sachiko; Kawakami, Koji

    2015-04-01

    Non-randomized controlled trials, cohort studies and database studies are appealing study designs when there are urgent needs for safety data, outcomes of interest are rare, generalizability is a matter of concern, or randomization is not feasible. This paper reviews four typical case studies from methodological viewpoints and clarifies how to minimize bias in observational studies in oncology. In summary, researchers planning observational studies should be cautious of selection of appropriate databases, validity of algorithms for identifying outcomes, comparison with incident users or self-control, rigorous collection of information on potential confounders and reporting details of subject selection. Further, a careful study protocol and statistical analysis plan are also necessary. PMID:25589456

  8. Report to the NASA Administrator by the Aerospace Safety Advisory Panel on the Space Shuttle Program. Part 1: Observations and Conclusions

    NASA Technical Reports Server (NTRS)

    1976-01-01

    Each system was chosen on the basis of its importance with respect to crew safety and mission success. An overview of the systems management is presented. The space shuttle main engine, orbiter thermal protection system, avionics, external tanks and solid rocket boosters were examined. The ground test and ground support equipment programs were studied. Program management was found to have an adequate understanding of the significant ground and flight risks involved.

  9. Safety of long-term use of linezolid: results of an open-label study

    PubMed Central

    Vazquez, Jose A; Arnold, Anthony C; Swanson, Robert N; Biswas, Pinaki; Bassetti, Matteo

    2016-01-01

    Objective The objective of this study was to assess the long-term safety of linezolid in patients with chronic infections requiring treatment for ≥6 weeks. Enhanced monitoring for optic neuropathy was included to characterize the early development of this side effect and to identify ophthalmologic tests that might be valuable in early detection of this event. Methods This was a multicenter, open-label, pilot study of patients aged ≥18 years on long-term linezolid therapy. Matched control patients were included for baseline assessment comparison. Patients were assessed at study entry, monthly while on treatment, at the end of treatment, and 30 days following the last dose. Aggregate ocular safety data were reviewed. Response to treatment was reported. Results The study was terminated owing to slow enrollment. Twenty-four patients received linezolid; nine patients were included as matched controls. Linezolid was prescribed for a median of 80.5 days (range, 50–254 days). In patients with a reported clinical outcome, the majority were considered improved or cured. Common treatment-related adverse events (AEs) included anemia, peripheral neuropathy, polyneuropathy, vomiting, and asthenia, and were consistent with the known safety profile. Most AEs resolved or stabilized with discontinuation of treatment. Results of ophthalmologic tests in the one case adjudicated as probable linezolid-associated optic neuropathy revealed abnormal color vision, characteristic changes in the optic disk, and central scotomas in each eye. Conclusion In our small population, linezolid was generally well tolerated and AEs were consistent with the known safety profile. Extensive ophthalmologic testing of all 24 linezolid-treated patients identified one case adjudicated as probable, linezolid-associated optic neuropathy. PMID:27621644

  10. Satellite Observation Systems for Polar Climate Change Studies

    NASA Technical Reports Server (NTRS)

    Comiso, Josefino C.

    2012-01-01

    The key observational tools for detecting large scale changes of various parameters in the polar regions have been satellite sensors. The sensors include passive and active satellite systems in the visible, infrared and microwave frequencies. The monitoring started with Tiros and Nimbus research satellites series in the 1970s but during the period, not much data was stored digitally because of limitations and cost of the needed storage systems. Continuous global data came about starting with the launch of ocean color, passive microwave, and thermal infrared sensors on board Nimbus-7 and Synthetic Aperture Radar, Radar Altimeter and Scatterometer on board SeaSat satellite both launched in 1978. The Nimbus-7 lasted longer than expected and provided about 9 years of useful data while SeaSat quit working after 3 months but provided very useful data that became the baseline for follow-up systems with similar capabilities. Over the years, many new sensors were launched, some from Japan Aeronautics and Space Agency (JAXA), some from the European Space Agency (ESA) and more recently, from RuSSia, China, Korea, Canada and India. For polar studies, among the most useful sensors has been the passive microwave sensor which provides day/night and almost all weather observation of the surface. The sensor provide sea surface temperature, precipitation, wind, water vapor and sea ice concentration data that have been very useful in monitoring the climate of the region. More than 30 years of such data are now available, starting with the Scanning Multichannel Microwave Radiometer (SMMR) on board the Nimbus-7, the Special Scanning Microwave/Imager (SSM/I) on board a Defense Meteorological Satellite Program (DMSP) and the Advanced Microwave Scanning Radiometer on board the EOS/ Aqua satellite. The techniques that have been developed to derive geophysical parameters from data provided by these and other sensors and associated instrumental and algorithm errors and validation techniques

  11. A literature review of safety culture.

    SciTech Connect

    Cole, Kerstan Suzanne; Stevens-Adams, Susan Marie; Wenner, Caren A.

    2013-03-01

    Workplace safety has been historically neglected by organizations in order to enhance profitability. Over the past 30 years, safety concerns and attention to safety have increased due to a series of disastrous events occurring across many different industries (e.g., Chernobyl, Upper Big-Branch Mine, Davis-Besse etc.). Many organizations have focused on promoting a healthy safety culture as a way to understand past incidents, and to prevent future disasters. There is an extensive academic literature devoted to safety culture, and the Department of Energy has also published a significant number of documents related to safety culture. The purpose of the current endeavor was to conduct a review of the safety culture literature in order to understand definitions, methodologies, models, and successful interventions for improving safety culture. After reviewing the literature, we observed four emerging themes. First, it was apparent that although safety culture is a valuable construct, it has some inherent weaknesses. For example, there is no common definition of safety culture and no standard way for assessing the construct. Second, it is apparent that researchers know how to measure particular components of safety culture, with specific focus on individual and organizational factors. Such existing methodologies can be leveraged for future assessments. Third, based on the published literature, the relationship between safety culture and performance is tenuous at best. There are few empirical studies that examine the relationship between safety culture and safety performance metrics. Further, most of these studies do not include a description of the implementation of interventions to improve safety culture, or do not measure the effect of these interventions on safety culture or performance. Fourth, safety culture is best viewed as a dynamic, multi-faceted overall system composed of individual, engineered and organizational models. By addressing all three components of

  12. Safety evaluation of pectin-derived acidic oligosaccharides (pAOS): genotoxicity and sub-chronic studies.

    PubMed

    Garthoff, Jossie A; Heemskerk, Suzanne; Hempenius, Rixta A; Lina, Ben A R; Krul, Cyrille A M; Koeman, Jan H; Speijers, Gerrit J A

    2010-06-01

    Pectin-derived acidic oligosaccharides (pAOS) are non-digestible carbohydrates to be used in infant formulae and medical nutrition. To support its safety, the genotoxic potential of pAOS was evaluated. pAOS was not mutagenic in the Ames test. Positive results were obtained in the chromosome aberration test only at highly cytotoxic concentrations. The effects obtained in the mouse lymphoma test were equivocal; pAOS was not mutagenic in vivo. A sub-chronic dietary study, preceded by 4-week parental and in utero exposure phase, investigated general safety. Administration of pAOS did not affect parental health nor pup characteristics. No effects specific for acidic oligosaccharides were observed in the subsequent sub-chronic study. Slight diffuse hyperplasia of epithelial layer of the urinary bladder was noted to result from concurrently elevated urinary sodium, due to high sodium in pAOS, and elevated urinary pH. This phenomenon was confirmed in a mechanistic (sub-chronic) study. In contrast, in rats fed pAOS in combination with NH(4)Cl, an acidifying agent, the induced low urinary pH completely prevented the development of urothelial hyperplasia. Hyperplasia induced by this mechanism in rats is considered not relevant to man. Based on the current knowledge we consider pAOS safe for human consumption under its intended use. PMID:20026148

  13. A cross-sectional mixed methods study protocol to generate learning from patient safety incidents reported from general practice

    PubMed Central

    Carson-Stevens, Andrew; Hibbert, Peter; Avery, Anthony; Butlin, Amy; Carter, Ben; Cooper, Alison; Evans, Huw Prosser; Gibson, Russell; Luff, Donna; Makeham, Meredith; McEnhill, Paul; Panesar, Sukhmeet S; Parry, Gareth; Rees, Philippa; Shiels, Emma; Sheikh, Aziz; Ward, Hope Olivia; Williams, Huw; Wood, Fiona; Donaldson, Liam; Edwards, Adrian

    2015-01-01

    Introduction Incident reports contain descriptions of errors and harms that occurred during clinical care delivery. Few observational studies have characterised incidents from general practice, and none of these have been from the England and Wales National Reporting and Learning System. This study aims to describe incidents reported from a general practice care setting. Methods and analysis A general practice patient safety incident classification will be developed to characterise patient safety incidents. A weighted-random sample of 12 500 incidents describing no harm, low harm and moderate harm of patients, and all incidents describing severe harm and death of patients will be classified. Insights from exploratory descriptive statistics and thematic analysis will be combined to identify priority areas for future interventions. Ethics and dissemination The need for ethical approval was waivered by the Aneurin Bevan University Health Board research risk review committee given the anonymised nature of data (ABHB R&D Ref number: SA/410/13). The authors will submit the results of the study to relevant journals and undertake national and international oral presentations to researchers, clinicians and policymakers. PMID:26628526

  14. A cross-sectional observational study of helmet use among motorcyclists in Wa, Ghana.

    PubMed

    Akaateba, Millicent Awialie; Amoh-Gyimah, Richard; Yakubu, Ibrahim

    2014-03-01

    Motorcyclists' injuries and fatalities are a major public health concern in many developing countries including Ghana. This study therefore aimed to investigate the prevalence of helmet use among motorcyclists in Wa, Ghana. The method used involved a cross-sectional roadside observation at 12 randomly selected sites within and outside the CBD of Wa. A total of 14,467 motorcyclists made up of 11,360 riders and 3107 pillion riders were observed during the study period. Most observed riders (86.5%) and pillion riders (61.7%) were males. The overall prevalence of helmet use among the observed motorcyclists was 36.9% (95% CI: 36.1-37.7). Helmet use for riders was 45.8% (95% CI: 44.8-46.7) whilst that for pillion riders was 3.7% (95 CI: 3.0-4.4). Based on logistic regression analysis, higher helmet wearing rates were found to be significantly associated with female gender, weekdays, morning periods and at locations within the CBD. Riders at locations outside the CBD were about 7 times less likely to wear a helmet than riders within the CBD (48.9% compared to 42.3%; χ(2)(1)=49.526; p<0.001). The study concluded that despite the existence of a national helmet legislation that mandates the use of helmets by both riders and pillion riders on all roads in Ghana, helmet use is generally low in Wa. This suggests that all stakeholders in road safety should jointly intensify education on helmet use and pursue rigorous enforcement on all road types especially at locations outside the CBD to improve helmet use in Wa. PMID:24316503

  15. A study of improved MHR 50/100 toward a higher level of inherent safety

    SciTech Connect

    Minatsuki, I.; Otani, T.; Shimizu, K.; Oyama, S.; Tsukamoto, H.; Kunitomi, K.

    2012-07-01

    A new concept of the Mitsubishi small-sized High temperature gas-cooled modular Reactors (MHR-50/100) had been developed and published in papers. The study results of the first design concept show that the MHR-50/100 can achieve the inherent safety level set as a design target in case of water ingress during steam generator tube rupture accident. And more specifically, the reactor was shown to remain stable during long-term station black out (SBO) with protection of only passive devices during a depressurization accident and with additional motion of steam dump system during a water ingress accident. Recently greater requirements for safety of future nuclear plants including the MHR-50/100 have been expected. This study has thus made a key design improvement for the MHR-50/100 in order to secure the inherent safety aspect without reliance on active steam dump system in case of a water ingress accident. The innovative technologies listed below have been created and investigated to achieve the improved MHR-50/100 design; (1) Design improvement of steam generator, (2) Heat balance optimization of steam cycle, (3) Control system design of differential pressure between primary helium gas and water/steam, (4) Study on operation procedure during a water ingress accident. (authors)

  16. Inclusion of Safety Pharmacology Endpoints in Repeat-Dose Toxicity Studies.

    PubMed

    Redfern, Will S

    2015-01-01

    Whereas pharmacological responses tend to be fairly rapid in onset and are therefore detectable after a single dose, some diminish on repeated dosing, and others increase in magnitude and therefore can be missed or underestimated in single-dose safety pharmacology studies. Safety pharmacology measurements can be incorporated into repeat-dose toxicity studies, either routinely or on an ad hoc basis. Drivers for this are both scientific (see above) and regulatory (e.g. ICH S6, S7, S9). There are inherent challenges in achieving this: the availability of suitable technical and scientific expertise in the test facility, unsuitable laboratory conditions, use of simultaneous (as opposed to staggered) dosing, requirement for toxicokinetic sampling, unsuitability of certain techniques (e.g. use of anaesthesia, surgical implantation, food restriction), equipment availability at close proximity and sensitivity of the methods to detect small, clinically relevant, changes. Nonetheless, 'fit-for-purpose' data can still be acquired without requiring additional animals. Examples include assessment of behaviour, sensorimotor, visual and autonomic functions, ambulatory ECG and blood pressure, echocardiography, respiratory, gastrointestinal, renal and hepatic function. This is entirely achievable if the safety pharmacology measurements are relatively unobtrusive, both with respect to the animals and to the toxicology study itself. Careful pharmacological validation of any methods used, and establishing their detection sensitivity, is vital to ensure the credibility of generated data. PMID:26091647

  17. Thermal safety of ultrasound-enhanced ocular drug delivery: A modeling study

    SciTech Connect

    Nabili, Marjan; Geist, Craig E-mail: zderic@gwu.edu; Zderic, Vesna E-mail: zderic@gwu.edu

    2015-10-15

    Purpose: Delivery of sufficient amounts of therapeutic drugs into the eye for treatment of various ocular diseases is often a challenging task. Ultrasound was shown to be effective in enhancing ocular drug delivery in the authors’ previous in vitro and in vivo studies. Methods: The study reported here was designed to investigate the safety of ultrasound application and its potential thermal effects in the eye using PZFlex modeling software. The safety limit in this study was set as a temperature increase of no more than 1.5 °C based on regulatory recommendations and previous experimental safety studies. Acoustic and thermal specifications of different human eye tissues were obtained from the published literature. The tissues of particular interest in this modeling safety study were cornea, lens, and the location of optic nerve in the posterior eye. Ultrasound application was modeled at frequencies of 400 kHz–1 MHz, intensities of 0.3–1 W/cm{sup 2}, and exposure duration of 5 min, which were the parameters used in the authors’ previous drug delivery experiments. The baseline eye temperature was 37 °C. Results: The authors’ results showed that the maximal tissue temperatures after 5 min of ultrasound application were 38, 39, 39.5, and 40 °C in the cornea, 39.5, 40, 42, and 43 °C in the center of the lens, and 37.5, 38.5, and 39 °C in the back of the eye (at the optic nerve location) at frequencies of 400, 600, 800 kHz, and 1 MHz, respectively. Conclusions: The ocular temperatures reached at higher frequencies were considered unsafe based on current recommendations. At a frequency of 400 kHz and intensity of 0.8 W/cm{sup 2} (parameters shown in the authors’ previous in vivo studies to be optimal for ocular drug delivery), the temperature increase was small enough to be considered safe inside different ocular tissues. However, the impact of orbital bone and tissue perfusion should be included in future modeling efforts to determine the safety

  18. Regional Satellite Observations for Dryland Degradation Studies (Invited)

    NASA Astrophysics Data System (ADS)

    Prince, S. D.

    2009-12-01

    The lack of global scale maps of degraded drylands remains a significant obstacle to identification, prevention and mitigation of desertification. To fill this gap, maps are needed that have some or all of the following characteristics. i Use quantitative variables that have defined biogeophysical meaning. ii Identify areas that are currently in a state of desertification as well as showing areas having higher risk of degradation. iii Provide a synopsis of the condition of land over a number of years, not only a single point in time. iv Repeatable, using consistent observations and an explicit methodology, with a clear link to methods for monitoring and change detection. v Flexible enough to allow adaptation to regional needs while not compromising the ability to compare regions on the basis of consistent criteria. vi At a scale adequate to identify the normal spatial scales of desertification - sub-national, but greater than individual land holdings. vii Down-scalable to allow the specific factors and processes responsible for degradation in a specific location to be identified. viii Can be used as state variables in household-scale studies. ix Up-scalable to allow impacts on processes such as climate change that are relevant at a coarse spatial resolution. x Presented in a data base with appropriate additional maps, such as topography, land use, soil properties, and rainfall, to allow interpretation. xi Can be validated and have information on potential error. xii Not reliant on a single data source nor on a single institution.

  19. Breast feeding and the weekend effect: an observational study

    PubMed Central

    Fitzsimons, Emla; Vera-Hernández, Marcos

    2016-01-01

    Objective To compare the incidence of breast feeding by day of week of birth. Design Retrospective database study using 16 508 records from the 2005 and 2010 Infant Feeding Surveys. Setting England and Wales, UK. Participants Mothers of a sample of births from among all registered births in the periods August–September 2005 and August–October 2010. Main outcome measure Incidence of breast feeding after birth. Results Among babies of mothers who left full-time education aged 16 or under, the incidence of breast feeding was 6.7 percentage points lower (95% CI 1.4 to 12.1 percentage points) for those born on Saturdays than for those born on Mondays–Thursdays. No such differences by day of week of birth were observed among babies of mothers who left school aged 17 or over. Conclusions Breastfeeding policy should take into account differences in breast feeding by day of week of birth, which are apparent among low-educated mothers. Further research is needed to ascertain the reason for this finding. PMID:27401354

  20. Observational Buoy Studies of Coastal Air-Sea Fluxes.

    NASA Astrophysics Data System (ADS)

    Frederickson, Paul A.; Davidson, Kenneth L.

    2003-02-01

    Recent advancements in measurement and analysis techniques have allowed air-sea fluxes to be measured directly from moving platforms at sea relatively easily. These advances should lead to improved surface flux parameterizations, and thus to improved coupled atmosphere-ocean modeling. The Naval Postgraduate School has developed a `flux buoy' (FB) that directly measures air-sea fluxes, mean meteorological parameters, and one-dimensional and directional wave spectra. In this study, the FB instrumentation and data analysis techniques are described, and the data collected during two U.S. east coast buoy deployments are used to examine the impact of atmospheric and surface wave properties on air-sea momentum transfer in coastal ocean regions. Data obtained off Duck, North Carolina, clearly show that, for a given wind speed, neutral drag coefficients in offshore winds are higher than those in onshore winds. Offshore wind drag coefficients observed over the wind speed range from 5 to 21 m s1 were modeled equally well by a linear regression on wind speed, and a Charnock model with a constant of 0.016. Measurements from an FB deployment off Wallops Island, Virginia, show that neutral drag coefficients in onshore winds increase as the wind-wave direction differences increase, especially beyond ±60°.

  1. iPad use during ward rounds: an observational study.

    PubMed

    Lehnbom, Elin C; Adams, Kristian; Day, Richard O; Westbrook, Johanna I; Baysari, Melissa T

    2014-01-01

    Much clinical information is computerised and doctors' use of mobile devices such as iPad tablets to access this information is expanding rapidly. This study investigated the use of iPads during ward rounds and their usefulness in providing access to information during ward rounds. Ten teams of doctors at a large teaching hospital were given iPads for ten weeks and were observed on ward rounds for 77.3 hours as they interacted with 525 patients. Use of iPads and other information technology devices to access clinical information was recorded. The majority of clinical information was accessed using iPads (56.2%), followed by computers-on-wheels (35.8%), stationary PCs (7.9%) and smartphones (0.1%). Despite having read-only access on iPads, doctors were generally happy using iPads on ward rounds. These findings provide evidence of the value of iPads as a tool to access information at the point of care. PMID:25087529

  2. Serum YKL-40 and gestational diabetes - an observational cohort study.

    PubMed

    Gybel-Brask, Dorte; Johansen, Julia S; Christiansen, Ib J; Skibsted, Lillian; Høgdall, Estrid V S

    2016-09-01

    To examine serum YKL-40 in women developing gestational diabetes mellitus (GDM). In the present large observational cohort study of 1179 pregnant women, we determined serum YKL-40 four times during pregnancy (at gestational age 12, 20, 25, and 32 weeks). Pregnancy outcome was obtained from medical records. Sixty-eight women (5.8%) developed GDM. Serum YKL-40 increased from gestational age (GA) 12 weeks and the following weeks in the women who developed GDM and was independent of BMI, parity, and maternal age (OR = 2.69, 95% CI: 1.45-5.00, p = 0.002). No association was found between serum YKL-40 and the oral glucose tolerance test results. In conclusion, YKL-40 significantly increased in pregnant women with GDM compared with women without GDM, probably reflecting the low-grade inflammation of GDM. However, we did not find an association between serum concentrations of YKL-40 in early pregnancy and the development of GDM and thus we conclude that YKL-40 alone is not usable as a biomarker for early prediction of GDM. PMID:27457220

  3. Observational and numerical studies of extreme frontal scale contraction

    NASA Technical Reports Server (NTRS)

    Koch, Steven E.

    1995-01-01

    The general objective of this effort is to increase understanding of how frontal scale contraction processes may create and sustain intense mesoscale precipitation along intensifying cold fronts. The five-part project (an expansion of the originally proposed two-part project) employed conventional meteorological data, special mesoscale data, remote sensing measurements, and various numerical models. First an idealized hydrostatic modeling study of the scale contraction effects of differential cloud cover on low-level frontal structure and dynamics was completed and published in a peer-reviewed journal. The second objective was to complete and publish the results from a three dimensional numerical model simulation of a cold front in which differential sensible heating related to cloud coverage patterns was apparently crucial in the formation of a severe frontal squall line. The third objective was to use a nonhydrostatic model to examine the nonlinear interactions between the transverse circulation arising from inhomogeneous cloud cover, the adiabatic frontal circulation related to semi-geostrophic forcing, and diabatic effects related to precipitation processes, in the development of a density current-like microstructure at the leading edge of cold fronts. Although the development of a frontal model that could be used to initialize such a primitive equation model was begun, we decided to focus our efforts instead on a project that could be successfully completed in this short time, due to the lack of prospects for continued NASA funding beyond this first year (our proposal was not accepted for future funding). Thus, a fourth task was added, which was to use the nonhydrostatic model to test tentative hypotheses developed from the most detailed observations ever obtained on a density current (primarily sodar and wind profiler data). These simulations were successfully completed, the findings were reported at a scientific conference, and the results have recently been

  4. Field studies of safety security rescue technologies through training and response activities

    NASA Astrophysics Data System (ADS)

    Murphy, Robin R.; Stover, Sam

    2006-05-01

    This paper describes the field-oriented philosophy of the Institute for Safety Security Rescue Technology (iSSRT) and summarizes the activities and lessons learned during calendar year 2005 of its two centers: the Center for Robot-Assisted Search and Rescue and the NSF Safety Security Rescue industry/university cooperative research center. In 2005, iSSRT participated in four responses (La Conchita, CA, Mudslides, Hurricane Dennis, Hurricane Katrina, Hurricane Wilma) and conducted three field experiments (NJTF-1, Camp Hurricane, Richmond, MO). The lessons learned covered mobility, operator control units, wireless communications, and general reliability. The work has collectively identified six emerging issues for future work. Based on these studies, a 10-hour, 1 continuing education unit credit course on rescue robotics has been created and is available. Rescue robots and sensors are available for loan upon request.

  5. Solitaire FR revascularization device 4×40: safety study and effectiveness in preclinical models.

    PubMed

    Wainwright, John Michael; Jahan, Reza

    2016-07-01

    Recent randomized clinical trials have shown the benefit of stent retrievers for endovascular intervention in patients with acute ischemic stroke. The Solitaire 2 FR 4×40 device was developed to address longer clots as well as procedural difficulties. This study was undertaken to evaluate the safety of the new device in a swine model at 0, 30, and 90 days as well as its in vitro effectiveness. There were no significant differences in the overall animal health, tissue injury, hemorrhagic or thrombogenic events related to device usage. Based on the comparison at multiple time points, the Solitaire 2 4×40 device was similar in safety and usability to the Solitaire 2 4×20 device. Due to the additional length of the device, the Solitaire 2 4×40 device may in fact provide a number of additional technical benefits in the neurothrombectomy treatment of ischemic stroke. PMID:26101268

  6. Probabilistic Safety Study Applications Program for inspection of the Indian Point Unit 3 Nuclear Power Plant

    SciTech Connect

    Taylor, J.H.; Fullwood, R.; Fresco, A.

    1986-03-01

    By prioritizing the various areas of interest for inspection and by better defining inspection needs, the NRC expects to make more effective use of finite inspection resources by concentrating on those potential areas most significant to safety. Through review and application of the Indian Point Unit 3 Probabilistic Safety Study's numerical data and event tree modeling, and by utilizing related documents, a technical basis for prioritizing areas for NRC inspection has been developed. This was then tested at the plant site for the NRC Operating Reactor Inspection Program, I and E Manual Chapter 2515. Inspection activities addressed include normal operations, system and component testing, maintenance and surveillance. A computer program entitled NSPKTR, which was developed specifically for this program, modeled the internal plant states to the system level and performed the risk and importance calculations. 17 refs., 21 tabs.

  7. Mechanistic studies related to the safety of Li/SOCl2 cells

    NASA Technical Reports Server (NTRS)

    Carter, B. J.; Williams, R. M.; Tsay, F. D.; Rodriguez, A.; Kim, S.; Evans, M. M.; Frank, H.

    1985-01-01

    Mechanistic studies of the reactions in Li-SOCl2 cells have been undertaken to improve understanding of the safety problems of these cells. The electrochemical reduction of 1.5M LiAlCl4/SOCl2 has been investigated using gas chromatography, electron spin resonance spectroscopy, and infrared spectroscopy. Cl2 and S2Cl2 have been identified as intermediates in the reduction of SOCl2, along with a radical species (g/xx/ = 2.004, g/yy/ = 2.016, g/zz/ = 2.008) and the proposed triplet ground-state dimer of this radical. SO2 and sulfur have been identified as products. Based upon these findings, a mechanism for the electrochemical reduction of 1.5M LiAlCl4/SOCl2 has been proposed, and its implications for safety of Li-SOCl2 cells during discharge to +0.5V at 25-30 C are discussed.

  8. Ascending-dose study of noribogaine in healthy volunteers: pharmacokinetics, pharmacodynamics, safety, and tolerability.

    PubMed

    Glue, Paul; Lockhart, Michelle; Lam, Fred; Hung, Noelyn; Hung, Cheung-Tak; Friedhoff, Lawrence

    2015-02-01

    Noribogaine is the active metabolite of the naturally occurring psychoactive substance ibogaine, and may help suppress withdrawal symptoms in opioid-dependent subjects. The objectives of this Phase I study were to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of noribogaine. In this ascending single-dose, placebo-controlled, randomized, double-blind, parallel-group study in 36 healthy drug-free male volunteers, 4 cohorts (n = 9) received oral doses of 3, 10, 30, or 60 mg or matching placebo, with intensive safety and pharmacokinetic assessments out to 216 hours, along with pharmacodynamic assessments sensitive to the effects of mu-opioid agonists. Noribogaine was rapidly absorbed, with peak concentrations occurring 2-3 hours after oral dosing, and showed dose-linear increases of area under the concentration-time curve (AUC) and Cmax between 3 and 60 mg. The drug was slowly eliminated, with mean half-life estimates of 28-49 hours across dose groups. Apparent volume of distribution was high (mean 1417-3086 L across dose groups). No safety or tolerability issues were identified in any cohort. No mu-opioid agonist pharmacodynamic effects were noted in pupillometry or cold-pressor testing. Single oral doses of noribogaine 3-60 mg were safe and well tolerated in healthy volunteers. PMID:25279818

  9. Clinical pathology testing recommendations for nonclinical toxicity and safety studies. AACC-DACC/ASVCP Joint Task Force.

    PubMed

    Weingand, K; Bloom, J; Carakostas, M; Hall, R; Helfrich, M; Latimer, K; Levine, B; Neptun, D; Rebar, A; Stitzel, K

    1992-01-01

    Clinical pathology testing in nonclinical toxicity and safety studies is an important part of safety assessment. In recent years, clinical laboratory testing has rapidly expanded and improved. Some government regulatory agencies provide guidelines for clinical pathology testing in nonclinical toxicity and safety studies. To improve these testing guidelines and the resultant safety assessments, the American Association for Clinical Chemistry's Division of Animal Clinical Chemistry and the American Society for Veterinary Clinical Pathology formed a joint committee to provide expert recommendations for clinical pathology testing of laboratory species involved in subchronic and chronic nonclinical toxicity and safety studies. These recommendations include technical recommendations on blood collection techniques and hematology, serum chemistry, and urinalysis tests. PMID:1296288

  10. A longitudinal study of an intervention to improve road safety climate: climate as an organizational boundary spanner.

    PubMed

    Naveh, Eitan; Katz-Navon, Tal

    2015-01-01

    This study presents and tests an intervention to enhance organizational climate and expands existing conceptualization of organizational climate to include its influence on employee behaviors outside the organization's physical boundaries. In addition, by integrating the literatures of climate and work-family interface, the study explored climate spillover and crossover from work to the home domain. Focusing on an applied practical problem within organizations, we investigated the example of road safety climate and employees' and their families' driving, using a longitudinal study design of road safety intervention versus control groups. Results demonstrated that the intervention increased road safety climate and decreased the number of traffic violation tickets and that road safety climate mediated the relationship between the intervention and the number of traffic violation tickets. Road safety climate spilled over to the family domain but did not cross over to influence family members' driving. PMID:25133303

  11. Perspectives on Safety and Health among Migrant and Seasonal Farmworkers in the United States and Mexico: A Qualitative Field Study

    ERIC Educational Resources Information Center

    Stallones, Lorann; Acosta, Martha S. Vela; Sample, Pat; Bigelow, Philip; Rosales, Monica

    2009-01-01

    Context: A large number of hired farmworkers in the United States come from Mexico. Understanding safety and health concerns among the workers is essential to improving prevention programs. Purpose: The purpose of this pilot study was to obtain detailed information about safety and health concerns of hired farmworkers in Colorado and in Mexico.…

  12. Further study of the intrinsic safety of internally shorted lithium and lithium-ion cells within methane-air

    PubMed Central

    Dubaniewicz, Thomas H.; DuCarme, Joseph P.

    2015-01-01

    National Institute for Occupational Safety and Health (NIOSH) researchers continue to study the potential for lithium and lithium-ion battery thermal runaway from an internal short circuit in equipment for use in underground coal mines. Researchers conducted cell crush tests using a plastic wedge within a 20-L explosion-containment chamber filled with 6.5% CH4-air to simulate the mining hazard. The present work extends earlier findings to include a study of LiFePO4 cells crushed while under charge, prismatic form factor LiCoO2 cells, primary spiral-wound constructed LiMnO2 cells, and crush speed influence on thermal runaway susceptibility. The plastic wedge crush was a more severe test than the flat plate crush with a prismatic format cell. Test results indicate that prismatic Saft MP 174565 LiCoO2 and primary spiral-wound Saft FRIWO M52EX LiMnO2 cells pose a CH4-air ignition hazard from internal short circuit. Under specified test conditions, A123 systems ANR26650M1A LiFePO4 cylindrical cells produced no chamber ignitions while under a charge of up to 5 A. Common spiral-wound cell separators are too thin to meet intrinsic safety standards provisions for distance through solid insulation, suggesting that a hard internal short circuit within these cells should be considered for intrinsic safety evaluation purposes, even as a non-countable fault. Observed flames from a LiMnO2 spiral-wound cell after a chamber ignition within an inert atmosphere indicate a sustained exothermic reaction within the cell. The influence of crush speed on ignitions under specified test conditions was not statistically significant. PMID:26139958

  13. Feasibility of a hemodialysis safety checklist for nurses and patients: a quality improvement study

    PubMed Central

    Thomas, Alison; Silver, Samuel A.; Rathe, Andrea; Robinson, Pamela; Wald, Ron; Bell, Chaim M.; Harel, Ziv

    2016-01-01

    Background Patients with end-stage renal disease are at high risk for medical errors given their comorbidities, polypharmacy and coordination of care with other hospital departments. We previously developed a hemodialysis safety checklist (Hemo Pause) to be jointly completed by nurses and patients. Our objective was to determine the feasibility of using this checklist during every hemodialysis session for 3 months. Methods We conducted a single-center, prospective time series study. A convenience sample of 14 nurses and 22 prevalent in-center hemodialysis patients volunteered to participate. All participants were trained in the administration of the Hemo Pause checklist. The primary outcome was completion of the Hemo Pause checklist, which was assessed at weekly intervals. We also measured the acceptability of the Hemo Pause checklist using a local patient safety survey. Results There were 799 hemodialysis treatments pre-intervention (13 January–5 April 2014) and 757 post-intervention (5 May–26 July 2014). The checklist was completed for 556 of the 757 (73%) treatments. Among the hemodialysis nurses, 93% (13/14) agreed that the checklist was easy to use and 79% (11/14) agreed it should be expanded to other patients. Among the hemodialysis patients, 73% (16/22) agreed that the checklist made them feel safer and should be expanded to other patients. Conclusions The Hemo Pause safety checklist was acceptable to both nurses and patients over 3 months. Our next step is to spread this checklist locally and conduct a mixed methods study to determine mechanisms by which its use may improve safety culture and reduce adverse events. PMID:27274816

  14. A Study of Student Teaching Using Direct Observation.

    ERIC Educational Resources Information Center

    Coker, Joan G.; Coker, Homer

    Thirty-three student teachers were observed in elementary school classrooms to determine if they manifested 16 interactive behaviors identified as desirable by college of education faculty. Teaching assistants used the Georgia Assessment of Teaching Effectiveness (GATE), an instrument which requires the observers to objectively record, but not…

  15. Clinical efficacy and safety of biapenem for febrile neutropenia in patients with underlying hematopoietic diseases: a multi-institutional study.

    PubMed

    Nakagawa, Yasunori; Suzuki, Kenshi; Hirose, Takayuki; Chou, Takaaki; Fujisawa, Shin; Kida, Michiko; Usuki, Kensuke; Ishida, Yoji; Taniguchi, Shuichi; Kouzai, Yasuji; Tomoyasu, Shigeru; Miyazaki, Koji; Higashihara, Masaaki; Ando, Kiyoshi; Aoki, Sadao; Arai, Ayako; Akiyama, Nobu; Hatake, Kiyohiko; Okamoto, Shinichiro; Dan, Kazuo; Ohyashiki, Kazuma; Urabe, Akio

    2011-02-01

    A multi-institutional study was conducted to assess efficacy and safety of biapenem (BIPM), a carbapenem antibiotic, as an initial-stage therapeutic agent for febrile neutropenia (FN) in patients with hematopoietic diseases. A total of 216 patients from 25 medical institutions were enrolled in this study; of these, 204 were included in the safety analysis and 178 in the efficacy analysis. The combined (excellent and good) response rate was 67.9%, and antipyretic effect (subsidence + tendency to subsidence) was achieved within 3 and 5 days of treatment in 67.3 and 75.9% of patients, respectively. Thus, the clinical responses were gratifying. A response rate of 61.7% (37/60) was observed even in high-risk FN patients in whom neutrophil counts prior to and at 72 h after the start of BIPM were ≤100/μl. BIPM is considered to be a highly promising drug, with prompt onset of clinical benefit, as an initial-stage therapeutic agent for the treatment of FN in patients with hematopoietic diseases. PMID:20602137

  16. An Observational Study of Algol-Type Binary System

    NASA Astrophysics Data System (ADS)

    Zhang, J.

    2015-01-01

    very small, so is its impact spot. If the mass transfer rate is high, the energy transfer rate can be comparable to the intrinsic luminosity of the detached component star. The position of the impact spot can be determined by the orbital period, mass ratio, and the dimensionless potential. The temperature of the impact spot is very high, and it can be directly reflected by the humps on the light curves. (4) We discover a rare Algol binary V753 Mon, which is just in the process of mass ratio inversion. The mass ratio of this binary is very close to one, and the key evolutional stage provides an important observational source for the theoretical studies of binary evolution. (5) We introduce the light curve models and the related physical factors, including the shape of the orbit, the shape of the stars, gravity brightening, atmosphere model, limb darkening, reflection effect, eclipse effect, the third body and its third light, dark spots and magnetic effect, hot spots, asteroseismology, atmospheric eclipse, and circumstellar matter. The light curve analysis programs are presented. We analyze the parameters and show the relevant results, including the orbital inclination, surface temperature, metal abundance, gravity acceleration, the third light, stellar radius (expressed by the surface potential), the eccentricity of the orbit, and anomaly.

  17. A Study of the Extratropical Tropopause from Observations and Models

    NASA Astrophysics Data System (ADS)

    Wang, Shu Meir

    The extratropical tropopause is a familiar feature in meteorology; however, the understanding of the mechanisms for its existence, formation, maintenance and sharpness is still an active area of research. Son and Povalni (2007) used a simple general circulation model to produce the TIL (Tropopause Inversion Layer), and they found that the extratropical tropopause is more sensitive to the change of the horizontal resolution than to the change of the vertical resolution. The extratropical tropopause is sharper and lower in higher horizontal resolution. They also successfully mimicked the seasonal variation of the extratropical tropopause by changing the Equator-to-Pole temperature difference. They found these features of the extratropical tropopause, but they did not explain why these features were seen in their simplified model. In this research, we try to explain why these features of the extratropical tropopause are seen from both observations and the models. I have shown in my MS thesis that the distance from the jet is more associated with the extratropical tropopause than is the upper tropospheric relative vorticity (Wirth, 2001) from observations. In this research, the reproduction of the work is done from both the idealized and the full model run, and the results are similar to those from the observations, which show that even on synoptic time scales, the distance from the jet is more important in determining the extratropical tropopause height than is the upper tropospheric relative vorticity. It also explains the seasonal variations of the extratropical tropopause since the jet is more poleward in summer than in winter (the Equator-to-Pole temperature difference is smaller in summer than in winter), thus there is larger area at south of the jet which means the extratropical tropopause is sharper and higher at midlatitudes in summer than in winter. We believe that baroclinic mixing of PV is the key factor that sharpens the extratropical tropopause, and

  18. An Open-Label Extension Study of the Safety and Efficacy of Risperidone in Children and Adolescents with Autistic Disorder

    PubMed Central

    Hough, David; Singh, Jaskaran; Karcher, Keith; Pandina, Gahan

    2013-01-01

    Abstract Objective: The purpose of this study was to evaluate the long-term safety and efficacy of risperidone in treating irritability and related behaviors in children and adolescents with autistic disorders. Methods: In this 6 month (26 week) open-label extension (OLE) study, patients (5–17 years of age, who completed the previous fixed-dose, 6 week, double-blind [DB] phase) were flexibly dosed with risperidone based on body weight. The maximum allowed dose was 1.25 mg/day for those weighing 20 to <45 kg, and 1.75 mg/day for those weighing ≥45 kg. The study primarily assessed risperidone's safety; efficacy was assessed as a secondary end-point. Results: Fifty-six (71%) out of 79 enrolled patients completed the OLE; the most common discontinuations were for insufficient response (7 [9%]) or adverse events (AE) (5 [6%]). The most common (≥5% frequency in the total group) AEs were increased appetite (11% [n=9]); increased weight and vomiting (9% [n=7] each); sedation, pyrexia, and upper respiratory tract infection (8% [n=6] each); nasopharyngitis (6% [n=5]); and somnolence and fatigue (5% [n=4] each). Extrapyramidal AEs were reported in 6 (8%) patients. Increase in mean weight (11–15%) and body mass index (5–10%) occurred; one patient discontinued because of weight increase. One potentially prolactin-related AE (irregular menstruation) was reported. The risperidone high-dose group had the greatest mean improvement in sleep visual analog scale (24.6). All groups showed additional improvement in efficacy scale scores during the OLE. Conclusions: During this OLE, safety findings with risperidone treatment (maximum weight-based dose of 1.25 mg/day or 1.75 mg/day) were consistent with those observed in the DB phase, and with the current safety information for risperidone in autistic, psychiatric, and behavioral disorders. Patients experienced some additional improvement in irritability and related behaviors. Clinical Trials Registry: This phase-4

  19. The Feasibility of Establishing Highway Safety Manpower Development and Research Centers at University-Level Institutions. Final Report, Volume I: Study Report.

    ERIC Educational Resources Information Center

    Chorness, Maury H.; And Others

    To examine the feasibility of establishing Highway Safety Manpower Development and Research (HSMDR) Centers at university-level institutions which would produce three types of manpower--safety specialists, safety professionals, and research manpower, previous National Highway Safety Bureau research studies and approximately 50 federally funded…

  20. Seeking ethical approval for an international study in primary care patient safety

    PubMed Central

    Dovey, Susan; Hall, Katherine; Makeham, Meredith; Rosser, Walter; Kuzel, Anton; Van Weel, Chris; Esmail, Aneez; Phillips, Robert

    2011-01-01

    Seeking ethics committee approval for research can be challenging even for relatively simple studies occurring in single settings. Complicating factors such as multicentre studies and/or contentious research issues can challenge review processes, and conducting such studies internationally adds a further layer of complexity. This paper draws on the experiences of the LINNAEUS Collaboration, an international group of primary care researchers, in obtaining ethics approval to conduct an international study investigating medical error in general practice in six countries. It describes the ethics review processes applied to exactly the same research protocol for a study run in Australia, Canada, England, the Netherlands, New Zealand, and the US. Wide variation in ethics review responses to the research proposal occurred, from no approval being deemed necessary to the study plan narrowly avoiding rejection. The authors' experiences demonstrated that ethics committees operate in their own historical and cultural context, which can lead to radically different subjective interpretations of commonly-held ethical principles, and raised further issues such as ‘what is research?’. This first LINNAEUS study started when patient safety was a particularly sensitive subject. Although it is now a respectable area of inquiry, patient safety is still a topic that can excite emotions and prejudices. The LINNAEUS Collaboration now extends to more countries and continues to pursue an international research agenda, so reflection on the influences of history, social context, and structure of each country's ethical review processes is timely. PMID:21439178

  1. Seeking ethical approval for an international study in primary care patient safety.

    PubMed

    Dovey, Susan; Hall, Katherine; Makeham, Meredith; Rosser, Walter; Kuzel, Anton; Van Weel, Chris; Esmail, Aneez; Phillips, Robert

    2011-04-01

    Seeking ethics committee approval for research can be challenging even for relatively simple studies occurring in single settings. Complicating factors such as multicentre studies and/or contentious research issues can challenge review processes, and conducting such studies internationally adds a further layer of complexity. This paper draws on the experiences of the LINNAEUS Collaboration, an international group of primary care researchers, in obtaining ethics approval to conduct an international study investigating medical error in general practice in six countries. It describes the ethics review processes applied to exactly the same research protocol for a study run in Australia, Canada, England, the Netherlands, New Zealand, and the US. Wide variation in ethics review responses to the research proposal occurred, from no approval being deemed necessary to the study plan narrowly avoiding rejection. The authors' experiences demonstrated that ethics committees operate in their own historical and cultural context, which can lead to radically different subjective interpretations of commonly-held ethical principles, and raised further issues such as 'what is research?'. This first LINNAEUS study started when patient safety was a particularly sensitive subject. Although it is now a respectable area of inquiry, patient safety is still a topic that can excite emotions and prejudices. The LINNAEUS Collaboration now extends to more countries and continues to pursue an international research agenda, so reflection on the influences of history, social context, and structure of each country's ethical review processes is timely. PMID:21439178

  2. Evaluation of safety of A/H1N1 pandemic vaccination during pregnancy: cohort study

    PubMed Central

    Trotta, Francesco; Da Cas, Roberto; Spila Alegiani, Stefania; Gramegna, Maria; Venegoni, Mauro; Zocchetti, Carlo

    2014-01-01

    Objective To assess the risk of maternal, fetal, and neonatal outcomes associated with the administration of an MF59 adjuvanted A/H1N1 vaccine during pregnancy. Design Historical cohort study. Setting Singleton pregnancies of the resident population of the Lombardy region of Italy. Participants All deliveries between 1 October 2009 and 30 September 2010. Data on exposure to A/H1N1 pandemic vaccine, pregnancy, and birth outcomes were retrieved from regional databases. Vaccinated and non-vaccinated women were compared in a propensity score matched analysis to estimate risks of adverse outcomes. Main outcome measures Main maternal outcomes included type of delivery, admission to intensive care unit, eclampsia, and gestational diabetes; fetal and neonatal outcomes included perinatal deaths, small for gestational age births, and congenital malformations. Results Among the 86 171 eligible pregnancies, 6246 women were vaccinated (3615 (57.9%) in the third trimester and 2557 (40.9%) in the second trimester). No difference was observed in terms of spontaneous deliveries (adjusted odds ratio 1.02, 95% confidence interval 0.96 to 1.08) or admissions to intensive care units (0.95, 0.47 to 1.88), whereas a limited increase in the prevalence of gestational diabetes (1.26, 1.04 to 1.53) and eclampsia (1.19, 1.04 to 1.39) was seen in vaccinated women. Rates of fetal and neonatal outcomes were similar in vaccinated and non-vaccinated women. A slight increase in congenital malformations, although not statistically significant, was present in the exposed cohort (1.14, 0.99 to 1.31). Conclusions Our findings add relevant information about the safety of the MF59 adjuvanted A/H1N1 vaccine in pregnancy. Residual confounding may partly explain the increased risk of some maternal outcomes. Meta-analysis of published studies should be conducted to further clarify the risk of infrequent outcomes, such as specific congenital malformations. PMID:24874845

  3. Transurethral resection syndrome in elderly patients: a retrospective observational study

    PubMed Central

    2014-01-01

    Background Transurethral resection of the prostate (TURP) involves the risk of transurethral resection (TUR) syndrome owing to hyponatremia. Irrigation fluid type, duration of operation, and weight of resected mass have been evaluated as risk factors for TUR syndrome. The purpose of the present study was to identify risk factors related to TUR syndrome in the elderly. Methods After obtaining approval from the Institutional Review Board, data on all elderly males (aged 70 years and older) who underwent TURP under regional anesthesia over a 6-year period at our institution were retrospectively reviewed. TUR syndrome was defined as evidence of a central nervous system disturbance such as nausea, vomiting, restlessness, confusion, or even coma with a circulatory abnormality both intra- and post-operatively. Patients were divided into two groups, positive and negative, for the occurrence of the syndrome. Data such as previous medical history, preoperative and postoperative serum data, weight of resected mass, duration of operation, irrigation fluid drainage technique, anesthetic technique, operative infusion and transfusion volume, and neurological symptoms were collected. Only observational variables with p < 0.05 on univariate analyses were included in the multivariate logistic regression model to ascertain their independent effects on TUR syndrome. Results Of the 98 patients studied, 23 had TUR syndrome (23.5%, 95% confidence interval [CI] 14.9–32.0%). Multivariate regression analysis revealed that volume of plasma substitute ≥ 500 ml (odds ratio [OR] 14.7, 95% CI 2.9–74.5), continuous irrigation through a suprapubic cystostomy (OR 4.7, 95% CI 1.3–16.7), and weight of resected mass > 45 g (OR 4.1, 95% CI 1.2–14.7) were associated with significantly increased risks for TUR syndrome (Hosmer-Lemeshow test, p = 0.94, accuracy 84.7%). Conclusions These results suggest that the use of a plasma substitute and continuous irrigation through a

  4. Preclosure radiological safety evaluation: Exploratory Studies Facility; Yucca Mountain Site Characterization Project

    SciTech Connect

    Schelling, F.J.; Smith, J.D.

    1993-07-01

    A radiological safety evaluation is performed to determine the impacts of Exploratory Studies Facility (ESF) design changes on the preclosure public radiological safety for a potential nuclear waste repository at Yucca Mountain, Nevada. Although the ESF design has undergone significant modification, incorporation of the modified design requires only modest changes to the conceptual repository configuration. To the extent feasible, the results of earlier safety evaluations presented in SAND84-2641, SAND88-7061, and SAND89-7024, which were based on the original ESF configuration, are compared with the results for the modified configuration. This comparison provides an estimate of the range of analysis uncertainty. This preliminary analysis indicates that there are no Q-scenarios, which are defined as those scenarios with a net occurrence probability of greater than 10{sup {minus}6}/yr and produce a radiological dose at the 5-km controlled area boundary of greater than 0.5 rem. The analysis yielded estimates for an underground accident of a probability of 3.8 {times} 10{sup {minus}15}/yr and a dose of 1.5 rem. For a surface-initiated accident, a probability of 1.5 {times} 10{sup {minus}12}/yr and a dose of 0.6 rem was estimated.

  5. The safety profile of vorinostat (suberoylanilide hydroxamic acid) in hematologic malignancies: A review of clinical studies.

    PubMed

    Duvic, Madeleine; Dimopoulos, Meletios

    2016-02-01

    Histone acetyltransferases and histone deacetylases (HDACs) are multifunctional enzymes that posttranslationally modify both histone and nonhistone acetylation sites, affecting a broad range of cellular processes (e.g., cell cycle, apoptosis, and protein folding) often dysregulated in cancer. HDAC inhibitors are small molecules that directly interact with HDAC catalytic sites preventing the removal of acetyl groups, thereby counteracting the effects of HDACs. Since the first HDAC inhibitor, valproic acid, was investigated as a potential antitumor agent, there have been a number of other HDAC inhibitors developed to improve efficacy and safety. Despite significant progress in the management of patients with hematologic malignancies, overall survival is still poor. The discovery that HDACs may play a role in hematologic malignancies and preclinical studies showing promising activity with HDAC inhibitors in various tumor types, led to clinical evaluation of HDAC inhibitors as potential treatment options for patients with advanced hematologic malignancies. The Food and Drug Administration has approved two HDAC inhibitors, vorinostat (2006) and romidepsin (2009), for the treatment of cutaneous T-cell lymphoma. This review highlights the safety of HDAC inhibitors currently approved or being investigated for the treatment of hematologic malignancies, with a specific focus on the safety experience with vorinostat in cutaneous T-cell lymphoma. PMID:26827693

  6. Dose Ranging, Expanded Acute Toxicity and Safety Pharmacology Studies for Intravenously Administered Functionalized Graphene Nanoparticle Formulations

    PubMed Central

    Kanakia, Shruti; Toussaint, Jimmy; Chowdhury, Sayan Mullick; Tembulkar, Tanuf; Lee, Stephen; Jiang, Ya-Ping; Lin, Richard Z.; Shroyer, Kenneth R.; Moore, William; Sitharaman, Balaji

    2014-01-01

    Graphene nanoparticles dispersions show immense potential as multifunctional agents for in vivo biomedical applications. Herein, we follow regulatory guidelines for pharmaceuticals that recommend safety pharmacology assessment at least 10 – 100 times higher than the projected therapeutic dose, and present comprehensive single dose response, expanded acute toxicology, toxicokinetics, and respiratory/cardiovascular safety pharmacology results for intravenously administered dextran-coated graphene oxide nanoplatelet (GNP-Dex) formulations to rats at doses between 1–500 mg/kg. Our results indicate that the maximum tolerable dose (MTD) of GNP-Dex is between 50 mg/kg ≤ MTD < 125 mg/kg, blood half-life < 30 minutes, and majority of nanoparticles excreted within 24 hours through feces. Histopathology changes were noted at ≥ 250 mg/kg in the heart, liver, lung, spleen, and kidney; we found no changes in the brain and no GNP-Dex related effects in the cardiovascular parameters or hematological factors (blood, lipid, and metabolic panels) at doses < 125 mg/kg. The results open avenues for pivotal preclinical single and repeat dose safety studies following good laboratory practices (GLP) as required by regulatory agencies for investigational new drug (IND) application. PMID:24854092

  7. Safety of desirudin in thrombosis prevention after total knee arthroplasty: the DESIR-ABLE study.

    PubMed

    Jove, Maurice; Maslanka, Marc; Minkowitz, Harold S; Jaffer, Amir K

    2014-01-01

    Desirudin, administered 30 minutes before total hip arthroplasty is superior to enoxaparin in preventing proximal deep vein thrombosis (DVT) and pulmonary embolism (PE) with similar bleeding. The purpose of this study was to determine the safety of desirudin in patients undergoing elective total knee arthroplasty (TKA) when the first dose of desirudin was administered the evening after surgery. This is a case series of patients undergoing TKA who received desirudin 15 mg every 12 hours subcutaneously for an average of 5 days with the first dose administered postoperatively. The primary endpoint was major bleeding; secondary endpoints included wound outcomes (oozing and infection) and new symptomatic DVT or PE. Desirudin has a favorable safety profile when administered postoperatively in patients undergoing TKA with no reports of major bleeding, wound ooze, or infection. No patients experienced symptomatic DVT, but 2 patients had PE detected by computed tomography after experiencing atypical symptoms. The safety profile of desirudin is improved when administered postoperatively. Bleeding and wound outcomes seem to occur less frequently than historical desirudin and enoxaparin controls. PMID:23344102

  8. Safety Risk Knowledge Elicitation in Support of Aeronautical R and D Portfolio Management: A Case Study

    NASA Technical Reports Server (NTRS)

    Shih, Ann T.; Ancel, Ersin; Jones, Sharon Monica; Reveley, Mary S.; Luxhoj, James T.

    2012-01-01

    Aviation is a problem domain characterized by a high level of system complexity and uncertainty. Safety risk analysis in such a domain is especially challenging given the multitude of operations and diverse stakeholders. The Federal Aviation Administration (FAA) projects that by 2025 air traffic will increase by more than 50 percent with 1.1 billion passengers a year and more than 85,000 flights every 24 hours contributing to further delays and congestion in the sky (Circelli, 2011). This increased system complexity necessitates the application of structured safety risk analysis methods to understand and eliminate where possible, reduce, and/or mitigate risk factors. The use of expert judgments for probabilistic safety analysis in such a complex domain is necessary especially when evaluating the projected impact of future technologies, capabilities, and procedures for which current operational data may be scarce. Management of an R&D product portfolio in such a dynamic domain needs a systematic process to elicit these expert judgments, process modeling results, perform sensitivity analyses, and efficiently communicate the modeling results to decision makers. In this paper a case study focusing on the application of an R&D portfolio of aeronautical products intended to mitigate aircraft Loss of Control (LOC) accidents is presented. In particular, the knowledge elicitation process with three subject matter experts who contributed to the safety risk model is emphasized. The application and refinement of a verbal-numerical scale for conditional probability elicitation in a Bayesian Belief Network (BBN) is discussed. The preliminary findings from this initial step of a three-part elicitation are important to project management practitioners as they illustrate the vital contribution of systematic knowledge elicitation in complex domains.

  9. Assuring consumer safety without animal testing: a feasibility case study for skin sensitisation.

    PubMed

    Maxwell, Gavin; Aleksic, Maja; Aptula, Aynur; Carmichael, Paul; Fentem, Julia; Gilmour, Nicola; Mackay, Cameron; Pease, Camilla; Pendlington, Ruth; Reynolds, Fiona; Scott, Daniel; Warner, Guy; Westmoreland, Carl

    2008-11-01

    Allergic Contact Dermatitis (ACD; chemical-induced skin sensitisation) represents a key consumer safety endpoint for the cosmetics industry. At present, animal tests (predominantly the mouse Local Lymph Node Assay) are used to generate skin sensitisation hazard data for use in consumer safety risk assessments. An animal testing ban on chemicals to be used in cosmetics will come into effect in the European Union (EU) from March 2009. This animal testing ban is also linked to an EU marketing ban on products containing any ingredients that have been subsequently tested in animals, from March 2009 or March 2013, depending on the toxicological endpoint of concern. Consequently, the testing of cosmetic ingredients in animals for their potential to induce skin sensitisation will be subject to an EU marketing ban, from March 2013 onwards. Our conceptual framework and strategy to deliver a non-animal approach to consumer safety risk assessment can be summarised as an evaluation of new technologies (e.g. 'omics', informatics), leading to the development of new non-animal (in silico and in vitro) predictive models for the generation and interpretation of new forms of hazard characterisation data, followed by the development of new risk assessment approaches to integrate these new forms of data and information in the context of human exposure. Following the principles of the conceptual framework, we have been investigating existing and developing new technologies, models and approaches, in order to explore the feasibility of delivering consumer safety risk assessment decisions in the absence of new animal data. We present here our progress in implementing this conceptual framework, with the skin sensitisation endpoint used as a case study. PMID:19025323

  10. Safety and efficacy of the modified peroral endoscopic myotomy with shorter myotomy for achalasia patients: a prospective study.

    PubMed

    Wang, J; Tan, N; Xiao, Y; Chen, J; Chen, B; Ma, Z; Zhang, D; Chen, M; Cui, Y

    2015-01-01

    Peroral endoscopic myotomy (POEM) has been developed as a minimally invasive endoscopic treatment for achalasia for years. However, the optimal length of submucosal tunnel and myotomy of muscle bundles during procedure of POEM has not yet been determined, so we aim to assess safety and efficacy of modified POEM with shorter myotomy of muscle bundles in achalasia patients. Consecutive achalasia patients had been performed modified POEM with shorter myotomy, and assessed by symptoms, high-resolution manometry, and barium swallow examinations before and 3 months after POEM for safety and efficacy evaluation. Modified POEM with shorter submucosal tunnel (mean length 6.8 cm) and endoscopic myotomy of muscle bundles (total mean length 5.4 cm) were completed in 46 consecutive achalasia patients. During the 3-month follow up in all cases, significant improvement of symptoms (a significant drop in the Eckardt score 8.4 ± 3.2 vs. 2.7 ± 1.9; P < 0.001), decreased lower esophageal sphincter pressure (39.4 ± 10.1 vs. 24.4 ± 9.1 mmHg; P < 0.001) and integrated relaxation pressure (38.6 ± 10.4 vs. 25.7 ± 9.6 mmHg; P < 0.01), and a drop in height of esophagus barium-contrast column (5.4 ± 3.1 vs. 2.6 ± 1.8 cm; P < 0.001) were observed. The frequencies of adverse events were lower in those under endotracheal anesthesia and CO2 insufflations compared with intravenous anesthesia and air insufflations. Only three patients were found to have gastroesophageal reflux disease on follow up. Modified POEM with shorter myotomy under endotracheal anesthesia and CO2 insufflations shows its good safety and excellent short-term efficacy in the treatment of achalasia. But further studies are warranted to assess the long-term efficacy. PMID:25214469

  11. Nuclear safety

    NASA Technical Reports Server (NTRS)

    Buden, D.

    1991-01-01

    Topics dealing with nuclear safety are addressed which include the following: general safety requirements; safety design requirements; terrestrial safety; SP-100 Flight System key safety requirements; potential mission accidents and hazards; key safety features; ground operations; launch operations; flight operations; disposal; safety concerns; licensing; the nuclear engine for rocket vehicle application (NERVA) design philosophy; the NERVA flight safety program; and the NERVA safety plan.

  12. [Observational study on urinary status following HoLEP].

    PubMed

    Kono, Yuka; Matsumoto, Keiyu; Masuda, Norihiko; Shiraishi, Yusuke; Negoro, Hiromitsu; Utsunomiya, Noriaki; Tsunemori, Hiroyuki; Okubo, Kazutoshi; Okada, Takuya; Segawa, Takehiko; Muguruma, Koei; Kawakita, Mutsushi

    2014-02-01

    We assessed the safety, and postoperative urinary status of holmium laser enucleation of the prostate (HoLEP) for the treatment of benign prostatic hyperplasia (BPH). Of the initial 117 patients who underwent HoLEP from November 2004 to March 2011, 49 were followed up for two yearsor longer. These 49 patients were evaluated once preoperatively, and at the 3rd, 6th, 12th, 24th, 48th, and 60th month postoperatively using International Prostate Symptom Scores (I-PSS) total and sub-score, quality of life score (QOL), maximum flow rate (Qmax), and post-voiding residual urine volume (PVR). The median estimated transition zone and enucleated volume were 45. 1 and 47. 9 g, respectively. Evaluation scores showed significant improvementsthroughout the follow-up. I-PSS total scoresimproved from 21 points(before surgery) to 6 points(12 monthsafter surgery), QOL scoresimproved from 5 pointsto 2 points, Qmax improved from 6.8 ml/s to 17.4 ml/s, and PVR improved from 101 ml to 26 ml, respectively. Transient urinary incontinence was noted in 14 patients (28.5%). One case showed a Clavien grade 3 complication of postoperative bleeding. No blood transfusion or re-surgery for BPH was required. In conclusion, HoLEP proved to be a safe and effective therapy, with potential to become a new gold standard for treating BPH. PMID:24755814

  13. Scoping Study on the Safety Impact of Valve Spacing in Natural Gas Pipelines

    SciTech Connect

    Sulfredge, Charles David

    2007-07-01

    The U.S. Department of Transportation's Pipeline and Hazardous Materials Safety Administration (PHMSA) is responsible for ensuring the safe, reliable, and environmentally sound operation of the nation's natural gas and hazardous liquid pipelines. Regulations adopted by PHMSA for gas pipelines are provided in 49 CFR 192, and spacing requirements for valves in gas transmission pipelines are presented in 49 CFR 192.179. The present report describes the findings of a scoping study conducted by Oak Ridge National Laboratory (ORNL) to assist PHMSA in assessing the safety impact of system valve spacing. Calculations of the pressures, temperatures, and flow velocities during a set of representative pipe depressurization transients were carried out using a one-dimensional numerical model with either ideal gas or real gas properties for the fluid. With both ideal gas and real gas properties, the high-consequence area radius for any resulting fire as defined by Stevens in GRI-00/0189 was evaluated as one measure of the pipeline safety. In the real gas case, a model for convective heat transfer from the pipe wall is included to assess the potential for shut-off valve failures due to excessively low temperatures resulting from depressurization cooling of the pipe. A discussion is also provided of some additional factors by which system valve spacing could affect overall pipeline safety. The following conclusions can be drawn from this work: (1) Using an adaptation of the Stephens hazard radius criteria, valve spacing has a negligible influence on natural gas pipeline safety for the pipeline diameter, pressure range, and valve spacings considered in this study. (2) Over the first 30 s of the transient, pipeline pressure has a far greater effect on the hazard radius calculated with the Stephens criteria than any variations in the transient flow decay profile and the average discharge rate. (3) Other factors besides the Stephens criteria, such as the longer burn time for an

  14. An empirical study of coronal observations at the solar limb

    NASA Astrophysics Data System (ADS)

    Freed, Michael Scott

    Solar observations were employed in this work to quantify motion and structures seen in the sun's corona with particular attention given to features found at the solar limb. These features consist of coronal magnetic-null points, quiescent prominences, and post flare eruption plasma sheets. Extreme-ultraviolet (EUV) observations from the Solar Dynamics Observatory (SDO) spacecraft were used to determine the fidelity of the commonly used potential field source surface (PFSS) model for predicting the location of coronal magnetic-null-points. Several properties of the null points were also investigated to ascertain if they had any effect on their observability. Next, quiescent prominence observations from the Hinode/Solar Optical Telescope satellite were used to create velocity maps of the plasma found in these structures. The derived velocities provided insight into the vorticity, kinetic energy, and oscillations that reside in these prominences. Primarily, this investigation was concerned with determining the distribution of velocity and vorticity at different length scales by applying a power spectral density analysis. All of this information is intended to strengthen our understanding on how these prominences evolve and potentially become unstable. An identical analysis is then conducted on post-flare-eruption plasma sheets observed in EUV by the space based SDO and TRACE satellites. Investigating the dynamics that reside in these plasma sheets are crucial for understanding the conditions that trigger and accelerate the magnetic reconnection responsible for producing these energetic solar flares.

  15. Handover patterns: an observational study of critical care physicians

    PubMed Central

    2012-01-01

    Background Handover (or 'handoff') is the exchange of information between health professionals that accompanies the transfer of patient care. This process can result in adverse events. Handover 'best practices', with emphasis on standardization, have been widely promoted. However, these recommendations are based mostly on expert opinion and research on medical trainees. By examining handover communication of experienced physicians, we aim to inform future research, education and quality improvement. Thus, our objective is to describe handover communication patterns used by attending critical care physicians in an academic centre and to compare them with currently popular, standardized schemes for handover communication. Methods Prospective, observational study using video recording in an academic intensive care unit in Ontario, Canada. Forty individual patient handovers were randomly selected out of 10 end-of-week handover sessions of attending physicians. Two coders independently reviewed handover transcripts documenting elements of three communication schemes: SBAR (Situation, Background, Assessment, Recommendations); SOAP (Subjective, Objective, Assessment, Plan); and a standard medical admission note. Frequency and extent of questions asked by incoming physicians were measured as well. Analysis consisted of descriptive statistics. Results Mean (± standard deviation) duration of patient-specific handovers was 2 min 58 sec (± 57 sec). The majority of handovers' content consisted of recent and current patient status. The remainder included physicians' interpretations and advice. Questions posed by the incoming physicians accounted for 5.8% (± 3.9%) of the handovers' content. Elements of all three standardized communication schemes appeared repeatedly throughout the handover dialogs with no consistent pattern. For example, blocks of SOAP's Assessment appeared 5.2 (± 3.0) times in patient handovers; they followed Objective blocks in only 45.9% of the

  16. EUVE Io Plasma Torus Observations: Galileo Support and Variability Studies

    NASA Astrophysics Data System (ADS)

    Gladstone, G. Randall

    We propose a Large Observing Program (1000 ksec) to monitor and investigate EUV emissions from the Io plasma torus and Jupiter during the last four Galileo Europa Mission encounters. These encounters all occur in the last half of 1999 (on Aug. 12, Sept. 14, Oct. 11, and Nov. 26), and will provide a perhaps never-to-be-repeated opportunity for acquiring ground truth (i.e., in situ) measurements with which to calibrate remote sensing observations of the torus. With these new data, we will 1) monitor the global properties of the torus during the Galileo observation epoch, 2) resolve two important but closely spaced torus periodicities, 3) determine the torus stability time constants, 4) search for very faint localized emissions from the Galilean satellites, and 5) continue monitoring the Jovian dayglow. We feel that such a program will make excellent use of EUVEs capabilities, and will allow for a much deeper understanding of the physics of the Jovian system.

  17. Safety of inhaled glycopyrronium in patients with COPD: a comprehensive analysis of clinical studies and post-marketing data

    PubMed Central

    D’Urzo, Anthony D; Kerwin, Edward M; Chapman, Kenneth R; Decramer, Marc; DiGiovanni, Robert; D’Andrea, Peter; Hu, Huilin; Goyal, Pankaj; Altman, Pablo

    2015-01-01

    Background Chronic use of inhaled anticholinergics by patients with chronic obstructive pulmonary disease (COPD) has raised long-term safety concerns, particularly cardiovascular. Glycopyrronium is a once-daily anticholinergic with greater receptor selectivity than previously available agents. Methods We assessed the safety of inhaled glycopyrronium using data pooled from two analysis sets, involving six clinical studies and over 4,000 patients with COPD who received one of the following treatments: glycopyrronium 50μg, placebo (both delivered via the Breezhaler® device), or tiotropium 18 μg (delivered via the HandiHaler® device). Data were pooled from studies that varied in their duration and severity of COPD of the patients (ie, ≤12 weeks duration with patients having moderate or severe COPD; and >1 year duration with patients having severe and very severe COPD). Safety comparisons were made for glycopyrronium vs tiotropium or placebo. Poisson regression was used to assess the relative risk for either active drug or placebo (and between drugs where placebo was not available) for assessing the incidence of safety events. During post-marketing surveillance (PMS), safety was assessed by obtaining reports from various sources, and disproportionality scores were computed using EMPIRICA™. In particular, the cardiac safety of glycopyrronium during the post-marketing phase was evaluated. Results The overall incidence of adverse events and deaths was similar across groups, while the incidence of serious adverse events was numerically higher in placebo. Furthermore, glycopyrronium did not result in an increased risk of cerebro-cardiovascular events vs placebo. There were no new safety reports during the PMS phase that suggested an increased risk compared to results from the clinical studies. Moreover, the cardiac safety of glycopyrronium during the PMS phase was also consistent with the clinical data. Conclusion The overall safety profile of glycopyrronium was

  18. Unsafe riding practice among electric bikers in Suzhou, China: an observational study

    PubMed Central

    Yang, Jie; Hu, Yihe; Du, Wei; Powis, Brent; Ozanne-Smith, Joan; Liao, Yilan; Li, Ning; Wu, Ming

    2014-01-01

    Background Electric bike (E-bike)-related deaths have been increasing rapidly in China and such injuries may be partly attributable to unsafe riding practice. Objectives To describe potentially unsafe riding behaviours among electric bikers (E-bikers) and to investigate factors influencing these practices in China. Methods In September 2012, a cross-sectional observation study including a speed measurement component was conducted in Wuzhong (an urban district) and Zhangjiagang (a rural district) of Suzhou, Jiangsu Province, China. Hand-held radar speed metres were used to read travelling speeds of E-bikes and a pro forma observation checklist was used to collect data on road riding practice. Mixed-effect logistic regressions were used to calculate adjusted ORs and 95% CIs for the association between speeding, road rule violations and helmet use and their influencing factors. Results Among 800 E-bikes with a speed reading, 70.9% exceeded the designed speed limit of 20 km/h. Among a further 20 647 E-bikers observed, 38.3% did not comply with the road rules when entering intersections; and only 2.2% wore helmets. No regional variation was identified between urban and rural areas. Male E-bikers were associated with more speeding and road rule violations, whereas riding a pedal-equipped E-bike was associated with less road rule violations and less helmet use. Conclusions Unsafe riding practices such as speeding, road rule violations and lack of helmet use were commonplace among E-bikers, especially among men. The study findings indicate that measures aimed at improving E-bike safety are required in China. PMID:24435891

  19. Large-Scale periodic solar velocities: An observational study

    NASA Technical Reports Server (NTRS)

    Dittmer, P. H.

    1977-01-01

    Observations of large-scale solar velocities were made using the mean field telescope and Babcock magnetograph of the Stanford Solar Observatory. Observations were made in the magnetically insensitive ion line at 5124 A, with light from the center (limb) of the disk right (left) circularly polarized, so that the magnetograph measures the difference in wavelength between center and limb. Computer calculations are made of the wavelength difference produced by global pulsations for spherical harmonics up to second order and of the signal produced by displacing the solar image relative to polarizing optics or diffraction grating.

  20. Lifetime socioeconomic position and mortality: prospective observational study.

    PubMed Central

    Smith, G. D.; Hart, C.; Blane, D.; Gillis, C.; Hawthorne, V.

    1997-01-01

    OBJECTIVES: To assess the influence of socioeconomic position over a lifetime on risk factors for cardiovascular disease, on morbidity, and on mortality from various causes. DESIGN: Prospective observational study with 21 years of follow up. Social class was determined as manual or non-manual at three stages of participants' lives: from the social class of their father's job, the social class of their first job, and the social class of their job at the time of screening. A cumulative social class indicator was constructed, ranging from non-manual social class at all three stages of life to manual social class at all three stages. SETTING: 27 workplaces in the west of Scotland. PARTICIPANTS: 5766 men aged 35-64 at the time of examination. MAIN OUTCOME MEASURES: Prevalence and level of risk factors for cardiovascular disease; morbidity; and mortality from broad causes of death. RESULTS: From non-manual social class locations at all three life stages to manual at all stages there were strong positive trends for blood pressure, body mass index, current cigarette smoking, angina, and bronchitis. Inverse trends were seen for height, cholesterol concentration, lung function, and being an ex-smoker. 1580 men died during follow up. Age adjusted relative death rates in comparison with the men of non-manual social class locations at all three stages of life were 1.29 (95% confidence interval 1.08 to 1.56) in men of two non-manual and one manual social class; 1.45 (1.21 to 1.73) in men of two manual and one non-manual social class; and 1.71 (1.46 to 2.01) in men of manual social class at all three stages. Mortality from cardiovascular disease showed a similar graded association with cumulative social class. Mortality from cancer was mainly raised among men of manual social class at all three stages. Adjustment for a wide range of risk factors caused little attenuation in the association of cumulative social class with mortality from all causes and from cardiovascular disease

  1. Efficacy and safety of a new single-port model for appendectomy: Experimental study on swine

    PubMed Central

    Olijnyk, José Gustavo; Ferreira, Paulo Walter; Nácul, Miguel Prestes; Cavazzola, Leandro Totti

    2016-01-01

    CONTEXT: With the cooperation of surgeons and the engineering division of the company Bhio supply© (Esteio-RS, Brazil), a permanent single port was developed. AIMS: An experimental study assessed the safety and efficacy of the device using a swine laparoscopic appendectomy model (right salpingo-oophorectomy). SETTINGS AND DESIGN: Experimental randomised study. MATERIALS AND METHODS: A total of 20 pigs were randomised for the conventional laparoscopic (CL) three-trocar technique or the single Centry port (CPort) with two working channels, aided by a transparietal thread. Operative times, surgical complications, CO2 use, and pneumoperitoneal pressure were checked. Pressure and chromopertubation tests assessed the ligatures. STATISTICAL ANALYSIS USED: For quantitative outcomes, the Fisher's exact test analysed the samples to compare the surgeons in each group, the ANOVA test for parametric data (volume and pressure) and the Student's t-test for analysis of the fascial incision length. The binaries and isolated occurrence events were described in percentages. RESULTS: For all cases, pneumoperitoneum was maintained. The CPort group, however, resulted in higher CO2 use (26.18 l; standard deviation [SD] ± 11.09) than CL group (5.69 l; SD ± 2.44) (P < 0.01). The mean pressure in CPort group (6.604 mmHg, SD ± 1.793) was comparatively lower than in CL group (7.382 mmHg, SD ± 1.833) (P = 0.363). There was no statistical difference between operative times, ligature safety or adverse surgical events between the different groups and surgeons. CONCLUSION: The surgical technique used with the single port showed no differences in safety and efficacy. Though it does require more CO2 use, its working dynamics did not lead to increased operative times. The results were similar between the two surgeons in the study, suggesting that they can be reproduced. PMID:27073304

  2. Efficacy and safety of AZD3199 vs formoterol in COPD: a randomized, double-blind study

    PubMed Central

    2013-01-01

    Background We investigated the efficacy and safety of AZD3199, a novel inhaled ultra-LABA, with the main aim of establishing a dose that would maintain 24-hour bronchodilation in patients with COPD. Methods Patients (n = 329) were randomized to AZD3199 (200, 400 or 800 μg o.d.), formoterol (9 μg b.i.d.) or placebo via Turbuhaler® in a parallel group study. The primary objective of the study was to compare the clinical efficacy of three doses of AZD3199 inhaled once daily with 9 μg formoterol twice daily and placebo, over a 4-week treatment period in adults with moderate-to-severe COPD. After 4 weeks, peak (0–4 h) and trough (24–26 h) forced expiratory volume in 1 second (FEV1) were assessed as the primary efficacy outcome variables. Results All AZD3199 doses significantly increased mean peak and trough FEV1 versus placebo (106–171 ml and 97–110 ml increases, respectively), but with no clear dose–response; the level of bronchodilation was comparable to or greater than that achieved with formoterol. Forced vital capacity (FVC) at peak bronchodilation also significantly increased with AZD3199 versus placebo (153–204 ml). COPD symptom scores and reliever use were reduced with AZD3199, while FEV1 reversibility was unaltered. Adverse events were mild-to-moderate, with no safety concerns identified. Drug exposure was dose-proportional, but lower than predicted from healthy volunteers. Conclusions All three doses of AZD3199 produced 24-hour bronchodilation, but with no clear dose–response, suggesting that doses of 200 μg or less may be sufficient to maintain bronchodilation over 24 hours in patients with COPD. No safety concerns were identified. Further studies are required to determine the once-daily AZD3199 dose for COPD. Trial registration Clinicaltrials.gov, NCT00929708 PMID:23731768

  3. Study of the post-derailment safety measures on low-speed derailment tests

    NASA Astrophysics Data System (ADS)

    Guo, Lirong; Wang, Kaiyun; Lin, Jianhui; Zhang, Bing; Chen, Zaigang; Song, Xinwu; Du, Gaofeng

    2016-07-01

    Prevention of train from derailment is the most important issue for the railway system. Keeping derailed vehicle close to the track centreline is beneficial to minimise the severe consequences associated with derailments. In this paper, the post-derailment safety measures are studied based on low-speed derailment tests. Post-derailment devices can prevent deviation of the train from the rail by catching the rail, and they are mounted under the axle box. Considering the different structures of vehicles, both trailer and motor vehicles are equipped with the safety device and then separately used in low-speed derailment tests. In derailment tests, two kinds of track, namely the CRTS-I slab ballastless track and the CRTS-II bi-block sleeper ballastless track, are adopted to investigate the effect of the track types on the derailment. In addition, the derailment speed and the weight of the derailed vehicle are also taken into account in derailment tests. The test results indicate that the post-derailment movement of the vehicle includes running and bounce. Reducing the derailment speed and increasing the weight of the head of the train are helpful to reduce the possibility for derailments. For the CRTS-I slab ballastless track, the safety device can prevent trailer vehicles from deviating from the track centreline. The gearbox plays an important role in controlling the lateral displacement of motor vehicle after a derailment while the safety device contributes less to keep derailed motor vehicles on the track centreline. The lateral distance between the safety device and rails should be larger than 181.5 mm for protecting the fasteners system. And for the CRTS-II bi-block sleeper ballastless track, it helps to decrease the post-derailment distance due to the longitudinal impacts with sleepers. It can also restrict the lateral movement of derailed vehicle due to the high shoulders. The results suggest that, CRTS-II bi-block sleeper ballastless track should be widely used

  4. Application of the Safety Attitudes Questionnaire (SAQ) in Albanian hospitals: a cross-sectional study

    PubMed Central

    Gabrani, Adriatik; Hoxha, Adrian; Simaku, Artan; Gabrani, Jonila (Cyco)

    2015-01-01

    Objective To establish the reliability and validity of the translated version of the Safety Attitudes Questionnaire (SAQ) by evaluating its psychometric properties and to determine possible differences among nurses and physicians regarding safety attitudes. Design A cross-sectional study utilising the Albanian version of the SAQ and a demographic questionnaire. Setting Four regional hospitals in Albania. Participants 341 healthcare providers, including 132 nurses and 209 doctors. Main outcome measure(s) The translation, construct validity and internal validity of the SAQ. The SAQ includes six scales and 30 items. Results A total of 341 valid questionnaires were returned, for a response rate of 70%. The confirmatory factor analysis and its goodness-of-fit indices (standardised root mean square residual 0.075, root mean square error of approximation 0.044 and comparative fit index 0.97) showed good model fit. The Cronbach's α values for each of the scales of the SAQ ranged from 0.64 to 0.82. The percentage of hospital healthcare workers who had a positive attitude was 60.3% for the teamwork climate, 57.2% for the safety climate, 58.4% for job satisfaction, 37.4% for stress recognition, 59.3% for the perception of management and 49.5% for working conditions. Intercorrelations showed that the subscales had moderate-to-high correlations with one another. Nurses were more hesitant to admit and report errors; only 55% of physicians and 44% of nurses endorsed this statement (χ2=4.9, p=0.02). Moreover, nurses received lower scores on team work compared with doctors (N 45.7 vs D 52.3, p=0.01). Doctors denied the effects of stress and fatigue on their performance (N 46.7 vs D 39.5, p<0.01), neglecting the workload. Conclusions The SAQ is a useful tool for evaluating safety attitudes in Albanian hospitals. In light of the health workforce's poor recognition of stress, establishing patient safety programmes should be a priority among policymakers in Albania. PMID:25877270

  5. Studying Triggers for Interest and Engagement Using Observational Methods

    ERIC Educational Resources Information Center

    Renninger, K. Ann; Bachrach, Jessica E.

    2015-01-01

    In this article, we discuss the contribution of observational methods to understanding the processes involved in triggering interest and establishing engagement. We begin by reviewing the literatures on interest and engagement, noting their similarities, differences, and the utility to each of better understanding the triggering process. We then…

  6. Critical review of the reactor-safety study radiological health effects model. Final report

    SciTech Connect

    Cooper, D.W.; Evans, J.S.; Jacob, N.; Kase, K.R.; Maletskos, C.J.; Robertson, J.B.; Smith, D.G.

    1983-03-01

    This review of the radiological health effects models originally presented in the Reactor Safety Study (RSS) and currently used by the US Nuclear Regulatory Commission (NRC) was undertaken to assist the NRC in determining whether or not to revise the models and to aid in the revision, if undertaken. The models as presented in the RSS and as implemented in the CRAC (Calculations of Reactor Accident Consequences) Code are described and critiqued. The major elements analyzed are those concerning dosimetry, early effects, and late effects. The published comments on the models are summarized, as are the important findings since the publication of the RSS.

  7. Major bleeding in patients with atrial fibrillation receiving vitamin K antagonists: a systematic review of randomized and observational studies

    PubMed Central

    Roskell, Neil S.; Samuel, Miny; Noack, Herbert; Monz, Brigitta U.

    2013-01-01

    Aims Clinical trials have shown that anticoagulation with vitamin K antagonists (VKAs), e.g. warfarin, decreases the risk of stroke in patients with atrial fibrillation (AF); however, increased bleeding risk is one of the safety concerns. The primary objective was to conduct a systematic review of the published literature, assessing the risk of major bleeding and mortality in patients with AF treated with VKAs. Methods and results Online searches of MEDLINE, EMBASE, BIOSIS, and the Cochrane Library were performed to a pre-specified protocol from 1960 to March 2012 for randomized controlled trials (RCTs) and from January 1990 to March 2012 for observational studies. A total of 47 studies (16 RCTs and 31 observational studies) were included. Cumulative follow-up was 61 563 patient-years for RCTs and 484 241 patient-years for observational studies. The overall median incidence of major bleeding was 2.1 per 100 patient-years (range, 0.9–3.4 per 100 patient-years) for RCTs and 2.0 per 100 patient-years (range, 0.2–7.6 per 100 patient-years) for observational studies. With study year as a proxy for changing management patterns, some evidence of bleeding rates and/or their reporting increasing over time was noted. Mortality rates from observational studies were inadequately reported to allow comparison with those from RCT data. Conclusion The median rate of major bleeding in observational studies and RCTs is similar. The larger heterogeneity in bleeding rates observed in a real-life setting could reflect a high variability in standard of care of patients on VKAs and/or methodological differences between observational studies and/or variability in data sources. PMID:23407628

  8. The Long Range Reconnaissance and Observation System (LORROS) with the Kollsman, Inc. Model LH-40, Infrared (Erbium) Laser Rangefinder hazard analysis and safety assessment.

    SciTech Connect

    Augustoni, Arnold L.

    2004-09-01

    A laser hazard analysis and safety assessment was performed for the LH-40 IR Laser Rangefinder based on the 2000 version of the American National Standard Institute's Standard Z136.1, for the Safe Use of Lasers and Z136.6, for the Safe Use of Lasers Outdoors. The LH-40 IR Laser is central to the Long Range Reconnaissance and Observation System (LORROS). The LORROS is being evaluated by the Department 4149 Group to determine its capability as a long-range assessment tool. The manufacture lists the laser rangefinder as 'eye safe' (Class 1 laser classified under the CDRH Compliance Guide for Laser Products and 21 CFR 1040 Laser Product Performance Standard). It was necessary that SNL validate this prior to its use involving the general public. A formal laser hazard analysis is presented for the typical mode of operation.

  9. Relating voltage and thermal safety in Li-ion battery cathodes: a high-throughput computational study.

    PubMed

    Jain, Anubhav; Hautier, Geoffroy; Ong, Shyue Ping; Dacek, Stephen; Ceder, Gerbrand

    2015-02-28

    High voltage and high thermal safety are desirable characteristics of cathode materials, but difficult to achieve simultaneously. This work uses high-throughput density functional theory computations to evaluate the link between voltage and safety (as estimated by thermodynamic O2 release temperatures) for over 1400 cathode materials. Our study indicates that a strong inverse relationship exists between voltage and safety: just over half the variance in O2 release temperature can be explained by voltage alone. We examine the effect of polyanion group, redox couple, and ratio of oxygen to counter-cation on both voltage and safety. As expected, our data demonstrates that polyanion groups improve safety when comparing compounds with similar voltages. However, a counterintuitive result of our study is that polyanion groups produce either no benefit or reduce safety when comparing compounds with the same redox couple. Using our data set, we tabulate voltages and oxidation potentials for over 105 combinations of redox couple/anion, which can be used towards the design and rationalization of new cathode materials. Overall, only a few compounds in our study, representing limited redox couple/polyanion combinations, exhibit both high voltage and high safety. We discuss these compounds in more detail as well as the opportunities for designing safe, high-voltage cathodes. PMID:25636088

  10. Attentional bias toward safety predicts safety behaviors.

    PubMed

    Xu, Yaoshan; Li, Yongjuan; Wang, Guangxi; Yuan, Xiao; Ding, Weidong; Shen, Zhongxiang

    2014-10-01

    Safety studies have primarily focused on how explicit processes and measures affect safety behavior and subsequent accidents and injuries. Recently, safety researchers have paid greater attention to the role of implicit processes. Our research focuses on the role of attentional bias toward safety (ABS) in workplace safety. ABS is a basic, early-stage cognitive process involving the automatic and selective allocation of attentional resources toward safety cues, which reflect the implicit motivational state of employees regarding safety goal. In this study, we used two reaction time-based paradigms to measure the ABS of employees in three studies: two modified Stroop tasks (Studies 1 and 2) and a visual dot-probe task (Study 3). Results revealed that employees with better safety behavior showed significant ABS (Study 2), and greater ABS than employees with poorer safety behavior (Studies 1 and 2). Moreover, ABS was positively associated with the perceived safety climate and safety motivation of employees, both of which mediate the effect of ABS on safety behavior (Study 3). These results contributed to a deeper understanding of how early-stage automatic perceptual processing affects safety behavior. The practical implications of these results were also discussed. PMID:24922613

  11. Efficacy and safety of acupuncture for chronic dizziness: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Dizziness is one of the most challenging symptoms in medicine. No medication for dizziness in current use has well-established curative or prophylactic value or is suitable for long-term palliative use. Unconventional remedies, such as acupuncture, should be considered and scientifically evaluated. However, there has been relatively little evidence in randomized controlled clinical trials on acupuncture to treat chronic dizziness. The aim of our study is to evaluate the efficacy and safety of acupuncture in patients with dizziness. Methods/Design This trial is a randomized, single-blind, controlled study. A total of 80 participants will be randomly assigned to two treatment groups receiving acupuncture and sham acupuncture treatment, respectively, for 4 weeks. The primary outcome measures are the Dizziness Handicap Inventory (DHI) and the Vertigo Symptom Scale (VSS). Treatment will be conducted over a period of 4 weeks, at a frequency of two sessions per week. The assessment is at baseline (before treatment initiation), 4 weeks after the first acupuncture session, and 8 weeks after the first acupuncture session. Discussion The results from this study will provide clinical evidence on the efficacy and safety of acupuncture in patients with chronic dizziness. Trial registration International Standard Randomized Controlled Trial Number Register: ISRCTN52695239 PMID:24330810

  12. Safety profile of sural nerve in posterolateral approach to the ankle joint: MRI study.

    PubMed

    Ellapparadja, Pregash; Husami, Yaya; McLeod, Ian

    2014-05-01

    The posterolateral approach to ankle joint is well suited for ORIF of posterior malleolar fractures. There are no major neurovascular structures endangering this approach other than the sural nerve. The sural nerve is often used as an autologous peripheral nerve graft and provides sensation to the lateral aspect of the foot. The aim of this paper is to measure the precise distance of the sural nerve from surrounding soft tissue structures so as to enable safe placement of skin incision in posterolateral approach. This is a retrospective image review study involving 64 MRI scans. All measurements were made from Axial T1 slices. The key findings of the paper is the safety window for the sural nerve from the lateral border of tendoachilles (TA) is 7 mm, 1.3 cm and 2 cm at 3 cm above ankle joint, at the ankle joint and at the distal tip of fibula respectively. Our study demonstrates the close relationship of the nerve in relation to TA and fibula in terms of exact measurements. The safety margins established in this study should enable the surgeon in preventing endangerment of the sural nerve encountered in this approach. PMID:24158742

  13. Safety Evaluation of CNS Administered Biologics-Study Design, Data Interpretation, and Translation to the Clinic.

    PubMed

    Vuillemenot, Brian R; Korte, Sven; Wright, Teresa L; Adams, Eric L; Boyd, Robert B; Butt, Mark T

    2016-07-01

    Many central nervous system (CNS) diseases are inadequately treated by systemically administered therapies due to the blood brain barrier (BBB), which prevents achieving adequate drug concentrations at sites of action. Due to the increasing prevalence of neurodegenerative diseases and the inability of most systemically administered therapies to cross the BBB, direct CNS delivery will likely play an increasing role in treatment. Administration of large molecules, cells, viral vectors, oligonucleotides, and other novel therapies directly to the CNS via the subarachnoid space, ventricular system, or parenchyma overcomes this obstacle. Clinical experience with direct CNS administration of small molecule therapies suggests that this approach may be efficacious for the treatment of neurodegenerative disorders using biological therapies. Risks of administration into the brain tissue or cerebrospinal fluid include local damage from implantation of the delivery system and/or administration of the therapeutic and reactions affecting the CNS. Preclinical safety studies on CNS administered compounds must differentiate between the effects of the test article, the delivery device, and/or the vehicle, and assess exacerbations of reactions due to combinations of effects. Animal models characterized for safety assessment of CNS administered therapeutics have enabled human trials, but interpretation can be challenging. This manuscript outlines the challenges of preclinical intrathecal/intracerebroventricular/intraparenchymal studies, evaluation of results, considerations for special endpoints, and translation of preclinical findings to enable first-in-human trials. Recommendations will be made based on the authors' collective experience with conducting these studies to enable clinical development of CNS-administered biologics. PMID:27354708

  14. Broadband study of X-Per using Suzaku observations

    NASA Astrophysics Data System (ADS)

    Maitra, Chandreyee; Paul, Biswajit; Pragati Pradhan, MISS.; Raichur, Harsha

    2016-07-01

    We present detailed broadband timing and spectral analysis of the persistent, low luminosity and slowly spinning pulsar 'X-per' using a Suzaku observation of the source. We have found for the first time, evidence for different intensity states with signatures of changes in the accretion geometry of the source. In addition, we confirm the presence of the cyclotron resonance at 30 keV which varies with the intensity states providing very crucial inputs on the accretion geometry.

  15. Observations on ion track structure in semiconductors : a phenomenological study

    NASA Technical Reports Server (NTRS)

    Selva, L. E.; Wallace, R. E.

    2001-01-01

    An ion track structure model at the nanometer scale is presented. The model is based on electrostatic principles and is supported by observed experimental results conducted on power MOSFETs. The model predicts the existence of a transient induced electric field following the passage of an energetic heavy ion. There are two segments to the field (a radial and an axial component). It is the interaction of this transient electric field with the local environment that can trigger a catastrophic failure.

  16. Safety and Feasibility of Transcranial Direct Current Stimulation in Pediatric Hemiparesis: Randomized Controlled Preliminary Study

    PubMed Central

    Feyma, Tim; Menk, Jeremiah; Usset, Michelle; Vaith, Amy; Wood, Teddi Jean; Worthington, Rebecca; Krach, Linda E.

    2015-01-01

    Background Transcranial direct current stimulation (tDCS) is a form of noninvasive brain stimulation that has shown improved adult stroke outcomes. Applying tDCS in children with congenital hemiparesis has not yet been explored. Objective The primary objective of this study was to explore the safety and feasibility of single-session tDCS through an adverse events profile and symptom assessment within a double-blind, randomized placebo-controlled preliminary study in children with congenital hemiparesis. A secondary objective was to assess the stability of hand and cognitive function. Design A double-blind, randomized placebo-controlled pretest/posttest/follow-up study was conducted. Setting The study was conducted in a university pediatric research laboratory. Participants Thirteen children, ages 7 to 18 years, with congenital hemiparesis participated. Measurements Adverse events/safety assessment and hand function were measured. Intervention Participants were randomly assigned to either an intervention group or a control group, with safety and functional assessments at pretest, at posttest on the same day, and at a 1-week follow-up session. An intervention of 10 minutes of 0.7 mA tDCS was applied to bilateral primary motor cortices. The tDCS intervention was considered safe if there was no individual decline of 25% or group decline of 2 standard deviations for motor evoked potentials (MEPs) and behavioral data and no report of adverse events. Results No major adverse events were found, including no seizures. Two participants did not complete the study due to lack of MEP and discomfort. For the 11 participants who completed the study, group differences in MEPs and behavioral data did not exceed 2 standard deviations in those who received the tDCS (n=5) and those in the control group (n=6). The study was completed without the need for stopping per medical monitor and biostatisticial analysis. Limitations A limitation of the study was the small sample size, with data

  17. Aerosol properties from 4STAR observations: A sensitivity study

    NASA Astrophysics Data System (ADS)

    Kassianov, E.; Flynn, C.; Redemann, J.; Livingston, J. M.; Schmid, B.; Russell, P. B.; Sinyuk, A.

    2011-12-01

    Multi-spectral direct-beam observations of atmospheric aerosol and gas constituents have been taken successfully at a number of sites around the world by the airborne 14-Channel NASA Ames Airborne Tracking Sunphotometer (AATS-14). The recently developed airborne Spectrometer for Sky-Scanning, Sun-Tracking Atmospheric Research (4STAR) is the next generation of AATS-14 with ultraviolet, visible and near-infrared spectral coverage, increased number of channels (more than 1500 pixels) and the sky-scanning ability of the ground-based AERONET sun/sky photometers. While it is generally agreed that more measurements in terms of independent wavelengths and scattering angles would offer enhanced aerosol retrievals, the potential afforded by improved observational capabilities of the 4STAR has not yet been fully characterized. This paper will attempt to place the importance of improved spectrally- and angularly-resolved 4STAR observations within the context of the well-known AERONET intensive-property retrieval. In particular, we have developed model data sets comparable to the 4STAR measurements of direct sun and sky radiances and evaluated the impact on the retrieval from subsampling in wavelength and scattering angle.

  18. Safety and tolerance of the ReWalk™ exoskeleton suit for ambulation by people with complete spinal cord injury: A pilot study

    PubMed Central

    Zeilig, Gabi; Weingarden, Harold; Zwecker, Manuel; Dudkiewicz, Israel; Bloch, Ayala; Esquenazi, Alberto

    2012-01-01

    Objectives The objective of the study was to evaluate the safety and tolerance of use of the ReWalk™ exoskeleton ambulation system in people with spinal cord injury. Measures of functional ambulation were also assessed and correlated to neurological spinal cord level, age, and duration since injury. Study design Case series observational study. Setting A national spinal cord injury centre. Methods Six volunteer participants were recruited from the follow-up outpatient clinic. Safety was assessed with regard to falls, status of the skin, status of the spine and joints, blood pressure, pulse, and electrocardiography (ECG). Pain and fatigue were graded by the participants using a visual analogue scale pre- and post-training. Participants completed a 10-statement questionnaire regarding safety, comfort, and secondary medical effects. After being able to walk 100 m, timed up and go, distance walked in 6 minutes and 10-m timed walk were measured. Results There were no adverse safety events. Use of the system was generally well tolerated, with no increase in pain and a moderate level of fatigue after use. Individuals with lower level of spinal cord injury performed walking more efficiently. Conclusion Volunteer participants were able to ambulate with the ReWalk™ for a distance of 100 m, with no adverse effects during the course of an average of 13–14 training sessions. The participants were generally positive regarding the use of the system. PMID:22333043

  19. Efficacy and Safety of Alogliptin in Patients With Type 2 Diabetes: Analysis of the ATTAK-J Study

    PubMed Central

    Takeda, Hiroshi; Sasai, Nobuo; Ito, Shogo; Obana, Mitsuo; Takuma, Tetsuo; Takai, Masahiko; Kaneshige, Hideaki; Machimura, Hideo; Kanamori, Akira; Nakajima, Kazumi; Matsuba, Ikuro

    2016-01-01

    Background Dipeptidyl peptidase-4 (DPP-4) inhibitors have been shown to reduce hemoglobin A1c (HbA1c) in patients with type 2 diabetes, but the reduction varies between patients and adequate glycemic control may not be achieved. We evaluated the efficacy and safety of the DPP-4 inhibitor alogliptin in the real clinical setting, and analyzed factors associated with the improvement of HbA1c by alogliptin treatment. Methods A retrospective observational study was performed in patients with type 2 diabetes attending hospitals or clinics belonging to the Kanagawa Physicians Association who received treatment with alogliptin for 1 year or longer. Patients using insulin were excluded from the study. The efficacy endpoints were HbA1c (National Glycohemoglobin Standardization Program value), blood glucose (fasting/postprandial), body weight, blood pressure (systolic/diastolic), liver function (glutamate oxaloacetate transaminase, glutamate pyruvate transaminase, and γ-glutamyl transpeptidase), kidney function (serum creatinine and estimated glomerular filtration rate), serum lipids (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides), and serum amylase. Adverse events were compiled to assess safety. Results Of 330 patients whose case records were collected, 27 patients were excluded for protocol violations, leaving 303 patients to form the full analysis set. Compared with baseline, HbA1c showed a decrease by 0.54±1.22% (mean ± standard deviation) after 12 months of alogliptin treatment. Factor analysis demonstrated that the change of HbA1c after 12 months was significantly influenced by the baseline HbA1c level, duration of diabetes, concomitant use of sulfonylureas, and compliance with diet therapy. In addition, there was a significant reduction of total cholesterol, low-density lipoprotein cholesterol, and the estimated glomerular filtration rate after 12 months of alogliptin treatment, as well as a

  20. Safety of AS03-adjuvanted split-virion H1N1 (2009) pandemic influenza vaccine: a prospective cohort study

    PubMed Central

    Nazareth, Irwin; Tavares, Fernanda; Rosillon, Dominique; Haguinet, François; Bauchau, Vincent

    2013-01-01

    Objectives To assess the safety of an AS03-adjuvanted split virion H1N1 (2009) vaccine (Pandemrix) in persons vaccinated during the national pandemic influenza vaccination campaign in the UK. Design Prospective, cohort, observational, postauthorisation safety study. Setting 87 general practices forming part of the Medical Research Council General Practice Research Framework and widely distributed throughout England. Participants A cohort of 9143 individuals aged 7 months to 97 years who received at least one dose of the AS03-adjuvanted H1N1 pandemic vaccine during the national pandemic influenza vaccination campaign in the UK was enrolled. 94% completed the 6-month follow-up. Exclusion criteria were previous vaccination with other H1N1 pandemic vaccine and any child in care. Primary and secondary outcome measures Medically attended adverse events (MAEs) occurring within 31 days after any dose, serious adverse events (SAEs) and adverse events of special interest (AESIs) following vaccination were collected for all participants. Solicited adverse events (AEs) were assessed in a subset of participants. Results MAEs were reported in 1219 participants and SAEs in 113 participants during the 31-day postvaccination period. The most frequently reported MAEs and SAEs were consistent with events expected to be reported during the winter season in this population: lower respiratory tract infections, asthma and pneumonia. The most commonly reported solicited AEs were irritability in young children aged <5 years (61.8%), muscle aches in children aged 5–17 years (61.9%) and adults (46.9%). 18 AESIs, experienced by 14 patients, met the criteria to be considered for the observed-to-expected analyses. AESIs above the expected number were neuritis (1 case within 31 days) and convulsions (8 cases within 181 days). There were 41 deaths during the 181-day period after vaccination, fewer than expected. Conclusions Results indicate that the AS03-adjuvanted H1N1 pandemic

  1. Safety of docosahexaenoic acid (DHA) administered as DHA ethyl ester in a 9-month toxicity study in dogs.

    PubMed

    Dahms, Irina; Beilstein, Paul; Bonnette, Kimberly; Salem, Norman

    2016-06-01

    DHA Ethyl Ester (DHA-EE) is a 90% concentrated ethyl ester of docosahexaenoic acid manufactured from the microalgal oil. The objective of the 9-month study was to evaluate safety of DHA-EE administered to beagle dogs at dose levels 150, 1000 and 2000 mg/kg bw/day by oral gavage and to determine reversibility of any findings after a 2-month recovery period. DHA-EE was well tolerated at all doses. There were observations of dry flaky skin with occasional reddened areas at doses ≥1000 mg/kg bw/day. These findings lacked any microscopic correlate and were no longer present after the recovery period. There were no toxicologically relevant findings in body weights, body weight gains, food consumption, ophthalmological examinations, and ECG measurements. Test article-related changes in hematology parameters were limited to decreases in reticulocyte count in the high-dose males and considered non-adverse. In clinical chemistry parameters, dose-related decreases in cholesterol and triglycerides levels were observed at all doses in males and females and attributed to the known lipid-lowering effects of DHA. There were no effects on other clinical chemistry, urinalysis or coagulation parameters. There were no abnormal histopathology findings attributed to test article. The No-Observable-Adverse-Effect Level of DHA-EE was established at 2000 mg/kg bw/day for both genders. PMID:27036332

  2. Observational and Modeling Studies of Clouds and the Hydrological Cycle

    NASA Technical Reports Server (NTRS)

    Somerville, Richard C. J.

    1997-01-01

    Our approach involved validating parameterizations directly against measurements from field programs, and using this validation to tune existing parameterizations and to guide the development of new ones. We have used a single-column model (SCM) to make the link between observations and parameterizations of clouds, including explicit cloud microphysics (e.g., prognostic cloud liquid water used to determine cloud radiative properties). Surface and satellite radiation measurements were used to provide an initial evaluation of the performance of the different parameterizations. The results of this evaluation will then used to develop improved cloud and cloud-radiation schemes, which were tested in GCM experiments.

  3. Galilean satellite eclipse studies. I - Observations and satellite characteristics

    NASA Technical Reports Server (NTRS)

    Greene, T. F.; Smith, D. W.; Shorthill, R. W.

    1980-01-01

    Spectrophotometric light curves of 12 Galilean satellite eclipses are reported. The observations were made in 20 to 30 channels over the wavelength range 3240 to 10,500 A using the 200-in. telescope. The initial data processing is described. These data measure the Jovian aerosol content in the lower stratosphere and uppermost troposphere and the methane abundance in the lower stratosphere. The data are consistent with a lack of limb darkening on the Galilean satellites. The orbit of Callisto is shown to be inclined 0.08 + or - 0.02 deg to the equatorial plane of Jupiter.

  4. Observations on studies useful to asbestos operations and management activities

    SciTech Connect

    Wilmoth, R.C.; Powers, T.J.; Millette, J.R.

    1991-01-01

    Asbestos-containing materials found in buildings may release asbestos fibers into the air. Some of these fibers will eventually settle and attach to room surfaces (walls, furnishings, equipment, floors, and carpet) as part of normal dust. Activities like dusting, sweeping and vacuuming are likely to re-entrain the dust causing exposure to airborne asbestos. The paper discusses data that are largely observational in nature, but are illustrative of general trends of interest to those individuals dealing with the day-to-day problems of asbestos in buildings.

  5. A comparative study between a high-gain interconnected observer and an adaptive observer applied to IM-based WECS

    NASA Astrophysics Data System (ADS)

    Naifar, Omar; Boukettaya, Ghada; Oualha, Abdelmajid; Ouali, Abderrazak

    2015-05-01

    This paper is devoted to the investigation of the potentialities of induction motor sensorless strategies in speed control applications. A comparison study is carried out between two observation approaches dedicated to speed control strategies of induction machine (IM)-based wind energy conversion systems (WECS) under parametric variations, such as: i) the adaptive observer approach, which is based on the speed adaptation law and ii) the interconnected observer, that offers robustness and stability of the system with reduced CPU time. The comparison study is achieved considering four performance criteria: stability, robustness with respect to the variations of the machine inductances, robustness with respect to the variations of the machine resistances, feasibility of the torque estimation. It has been found that the introduced interconnected observer exhibits a higher performance than the traditional adaptive one, with respect to the above-cited comparison criteria.

  6. Effect of static electronic advertising signs on road safety: an experimental case study.

    PubMed

    Izadpanah, Pedram; Omrani, Reza; Koo, Sheldon; Hadayeghi, Ali

    2014-01-01

    As technology continues to advance, the outdoor advertising industry is taking advantage of electronic signs, some of which are static electronic signs (SES), with the ability to automatically change the message shown on the sign at regular intervals. Studies indicate that SES has a negative impact on the drivers' visual attention and on vehicle control. However, the actual effects of the SES on the number of collisions have been difficult to prove conclusively. The objective of this article is to generate a clear understanding of the safety impacts of SES on the number collisions by conducting a before-and-after analysis with comparison groups. The analysis was based on a total of 10 SES along the Highway 27 and the Gardiner Expressway of the city of Toronto. The results of the before-and-after study revealed that there was not enough evidence to suggest that these signs have any impact on road safety along the adjacent roadway sections at a 95% confidence interval. The same results were obtained by comparing collisions that occurred during daylight and artificial light. PMID:24682165

  7. To Study the Efficacy and Safety of Doxophylline and Theophylline in Bronchial Asthma

    PubMed Central

    Farhat, Samina; Kaur, Sharanjit; Teli, Hilal Ahmad

    2015-01-01

    Background Asthma is a non communicable chronic disease prevalent all over the world. Two commonly used methylxanthines, theophylline and doxofylline were compared in the study in stable asthmatic patients at recommended doses by various spirometric lung function tests with forced expiratory volume at second one (FEVI) between 50 to 80% of predicted FEVI. Materials and Methods A total of 100 patients were divided in two groups. Group I was administered 300 mg theophylline twice a day and Group II was administered doxofylline 400 mg twice a day orally for six weeks. Spirometric variables symptom score, and adverse effects were recorded at the baseline level and after six weeks of therapy. Data was compared and analysed statistically. Results The spirometric values of forced expiratory volume in 1 second (FEVI), forced vital capacity (FVC), and FEV1/FVC showed a statistically significant improvement over base line with the use of both theophylline as well as doxophylline, but were not statistically different from each other. There was a statistically significant improvement in peak expiratory flow rate (PEFR) after six weeks of treatment with doxophylline compared to theophylline. It was found that the doxophylline has a better safety profile as compared to theophylline. Adverse events occurred in a greater proportion of patients in the theophylline group. Conclusion In the study it was concluded that both theophylline and doxofylline improved the lung function tests and symptoms in patients of mild Bronchial Asthma, but doxofylline has a better profile in terms of safety. PMID:26023566

  8. SUPERFUND TREATABILITY CLEARINGHOUSE: SOIL STABILIZATION PILOT STUDY, UNITED CHROME NPL SITE PILOT STUDY AND HEALTH AND SAFETY PROGRAM, UNITED CHROME NPL SITE PILOT STUDY

    EPA Science Inventory

    This document is a project plan for a pilot study at the United Chrome NPL site, Corvallis, Oregon and includes the health and safety and quality assurance/quality control plans. The plan reports results of a bench-scale study of the treatment process as iieasured by the ...

  9. Conceptual design study of Fusion Experimental Reactor (FY86 FER): Safety

    NASA Astrophysics Data System (ADS)

    Seki, Yasushi; Iida, Hiromasa; Honda, Tsutomu

    1987-08-01

    This report describes the study on safety for FER (Fusion Experimental Reactor) which has been designed as a next step machine to the JT-60. Though the final purpose of this study is to have an image of design base accident, maximum credible accident and to assess their risk or probability, etc., as FER plant system, the emphasis of this years study is placed on fuel-gas circulation system where the tritium inventory is maximum. The report consists of two chapters. The first chapter summarizes the FER system and describes FMEA (Failure Mode and Effect Analysis) and related accident progression sequence for FER plant system as a whole. The second chapter of this report is focused on fuel-gas circulation system including purification, isotope separation and storage. Probability of risk is assessed by the probabilistic risk analysis (PRA) procedure based on FMEA, ETA and FTA.

  10. Model-observation comparison study of multiple polar cap arcs

    NASA Astrophysics Data System (ADS)

    Zhu, L.; Valladares, C. E.; Sojka, J. J.; Schunk, R. W.; Crain, D. J.

    1996-01-01

    A quantitative model-observation comparison of multiple polar cap arcs has been conducted by using a time-dependent theoretical model of polar cap arcs. In particular, the electrodynamical features of multiple polar cap arcs with various spacings are simulated and the results are compared with the images obtained from the All-Sky Intensified Photometer at Qaanaaq. The results show that the observed and simulated arcs are quite similar, both spatially and temporally. The results support the theory proposed by Zhu et al. [1993a, 1994b] that the structure of polar cap arcs is mainly determined by the magnetosphere-ionosphere (M-I) coupling processes and that the spacing of multiple polar cap arcs is closely related to the hardness of the primary magnetospheric precipitation. It is found that for the multiple polar cap arcs with both narrow and wide spacings, the associated field-aligned currents are mainly closed by Pedersen currents. It is also found that a hard precipitation can lead to a highly structured secondary arc because of the nonlinear M-I coupling processes.

  11. Safety and injury characteristics of youth farmworkers in North Carolina: a pilot study.

    PubMed

    Arcury, Thomas A; Rodriguez, Guadalupe; Kearney, Gregory D; Arcury, Justin T; Quandt, Sara A

    2014-01-01

    Agriculture is a unique US industry in how youth are involved. Youth employed in agriculture experience high rates of injury, and youth migrant and seasonal farmworkers may be extremely vulnerable. The primary aim for this analysis is to describe the personal characteristics, work characteristics, occupational safety behaviors, and occupational injuries of North Carolina youth farmworkers. This pilot study uses data from interviewer-administered questionnaires with 87 youth farmworkers. Participants included males (62.1%) and females (37.9%), with 26.4% aged 10-13 years, 39.1% 14-15 years, and 34.5% 16-17 years. The majority (78.2%) were born in the United States. Most worked in tobacco (46.0%), sweet potatoes (28.7%), and berries (28.7%). They were paid by the hour (54.0%) and piece rate (55.2%); 21.8% reported a problem getting paid the amount earned. Three quarters wore a hat, and 63.2% wore gloves while working. Five (5.7%) had received pesticide use training in the past year. Over half reported a musculoskeletal injury (54.0%), a traumatic injury (60.9%), or a dermatological injury (72.4%) in the last year. Six of the injuries led to medical treatment, and 10 resulted in missed school or work. Farmworker youth in North Carolina are at times not treated fairly when they work, occupational safety behaviors are limited (increasing exposure to pesticides and other environmental hazards), and they commonly experience injuries. Research on the occupational exposures and health experienced by youth farmworkers is needed to inform policy. Changes in policy are warranted to improve the safety of youth farmworkers. PMID:25275401

  12. Motorcycle safety, environmental effects, and performance studies. 1964-June, 1980 (a bibliography with abstracts). Report for 1964-June 1980

    SciTech Connect

    Kenton, E.

    1980-07-01

    The reports cited in this bibliography primarily are concerned with motorcycle safety and pollution. These studies cover safety equipment and education, visual and visibility factors, noise, fuel consumption, engine performance, air pollution, vehicle design, tire and brake characteristics, and illuminating systems. Testing programs are described for both machines and operators, underlining impact and anthropomorphic crash data. Training programs are noted for drivers. Particular attention is given to accident prevention, safety helmets, and protective clothing. (This updated bibliography contains 172 abstracts, 37 of which are new entries to the previous edition.)

  13. Reverse Discrimination by Minority Groups. A Participant Observation Study.

    ERIC Educational Resources Information Center

    Clavner, Jerry B.; Clavner, Catherine

    This study explores reverse discrimination as a cultural phenomenon that should be studied by anthropologists, and to which anthropology has inadvertently contributed. Discrimination by minority group memb