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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. 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

  2. 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.

  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

    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 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

  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. 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

  16. 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

  17. 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

  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. 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.

  17. 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

  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. 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

  1. 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.

  2. 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.

  3. 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...

  4. 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".

  5. 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

  6. 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

  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. 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…

  16. 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.

  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. 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.

  20. 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

  1. 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

  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. 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.

  9. 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.

  10. 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...

  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. 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

  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. 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.

  19. 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

  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. 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.

  6. 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.

  7. 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

  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. 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

  14. 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

  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. 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.

  20. 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.

  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. 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…

  5. 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…

  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. 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.

  4. 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

  5. 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.

  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. 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…

  15. 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.

  16. 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.

  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. 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

  19. 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.

  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. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  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. 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%…

  5. 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

  6. 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.

  7. 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

  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