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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. 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.

  3. Reporting of methodological features in observational studies of pre-harvest food safety.

    PubMed

    Sargeant, Jan M; O'Connor, Annette M; Renter, David G; Kelton, David F; Snedeker, Kate; Wisener, Lee V; Leonard, Erin K; Guthrie, Alessia D; Faires, Meredith

    2011-02-01

    Observational studies in pre-harvest food safety may be useful for identifying risk factors and for evaluating potential mitigation strategies to reduce foodborne pathogens. However, there are no structured reporting guidelines for these types of study designs in livestock species. Our objective was to evaluate the reporting of observational studies in the pre-harvest food safety literature using guidelines modified from the human healthcare literature. We identified 100 pre-harvest food safety studies published between 1999 and 2009. Each study was evaluated independently by two reviewers using a structured checklist. Of the 38 studies that explicitly stated the observational study design, 27 were described as cross-sectional studies, eight as case-control studies, and three as cohort studies. Study features reported in over 75% of the selected studies included: description of the geographic location of the studies, definitions and sources of data for outcomes, organizational level and source of data for independent variables, description of statistical methods and results, number of herds enrolled in the study and included in the analysis, and sources of study funding. However, other features were not consistently reported, including details related to eligibility criteria for groups (such as barn, room, or pen) and individuals, numbers of groups and individuals included in various stages of the study, identification of primary outcomes, the distinction between putative risk factors and confounding variables, the identification of a primary exposure variable, the referent level for evaluation of categorical variable associations, methods of controlling confounding variables and missing variables, model fit, details of subset analysis, demographic information at the sampling unit level, and generalizability of the study results. Improvement in reporting of observational studies of pre-harvest food safety will aid research readers and reviewers in interpreting and

  4. A pathway to improved prospective observational post-authorization safety studies.

    PubMed

    Kiri, Victor A

    2012-09-01

    Randomized controlled trials (RCTs) are the gold standard for assessing the efficacy of drugs but not necessarily so for drug safety where inadequate power to detect either multiple or rare adverse events is a major handicap. Furthermore, the conditions under which drugs are approved for market use are often different from the settings in actual use. Indeed, with their control mechanisms, trials are by design largely inadequate for the identification of potential safety signals, especially of the rare type, hence the value of postmarketing surveillance and risk management plan-based activities. Today, clinical trials constitute only a part of the research that goes into assessing the safety of drugs. Observational studies, where the investigators merely collect data on treatments received by patients and their health status in routine clinical practice are increasing in uptake because they reflect the real-life utility of drugs, despite the absence of random treatment assignment. Although such studies generally provide less compelling evidence than RCTs, they can be far more useful to drug safety assessment activities than generally acknowledged. An increasing number of post-authorization safety studies (PASS) within the European Medicines Agency's jurisdiction are of the observational type - considered perhaps as more appropriate vehicles for exploring and documenting how products perform in the real world. A similar trend is emerging in the US following the FDA Amendments Act of 2007; since early 2010, an increasing number of post-approval commitments mandated by the FDA include observational studies. However, despite this pattern, not much is known about ongoing efforts to address many of the recognized inadequacies associated with existing methodologies and practices currently adopted in observational PASS. This current opinion presents an overview of some of the main challenges we face in prospective observational PASS, mainly from practical experience, and

  5. 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

  6. 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

  7. 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

  8. Randomized controlled trials and real-world observational studies in evaluating cardiovascular safety of inhaled bronchodilator therapy in COPD

    PubMed Central

    Kardos, Peter; Worsley, Sally; Singh, Dave; Román-Rodríguez, Miguel; Newby, David E; Müllerová, Hana

    2016-01-01

    Long-acting muscarinic antagonist (LAMA) or long-acting β2-agonist (LABA) bronchodilators and their combination are recommended for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Although the efficacy of LAMAs and LABAs has been well established through randomized controlled trials (RCTs), questions remain regarding their cardiovascular (CV) safety. Furthermore, while the safety of LAMA and LABA monotherapy has been extensively studied, data are lacking for LAMA/LABA combination therapy, and the majority of the studies that have reported on the CV safety of LAMA/LABA combination therapy were not specifically designed to assess this. Evaluation of CV safety for COPD treatments is important because many patients with COPD have underlying CV comorbidities. However, severe CV and other comorbidities are often exclusion criteria for RCTs, contributing to a lack in external validity and generalizability. Real-world observational studies are another important tool to evaluate the effectiveness and safety of COPD therapies in a broader population of patients and can improve upon the external validity limitations of RCTs. We examine what is already known regarding the CV and cerebrovascular safety of LAMA/LABA combination therapy from RCTs and real-world observational studies, and explore the advantages and limitations of data derived from each study type. We also describe an ongoing prospective, observational, comparative post-authorization safety study of a LAMA/LABA combination therapy (umeclidinium/vilanterol) and LAMA monotherapy (umeclidinium) versus tiotropium, with a focus on the relative merits of the study design. PMID:27932872

  9. Randomized controlled trials and real-world observational studies in evaluating cardiovascular safety of inhaled bronchodilator therapy in COPD.

    PubMed

    Kardos, Peter; Worsley, Sally; Singh, Dave; Román-Rodríguez, Miguel; Newby, David E; Müllerová, Hana

    2016-01-01

    Long-acting muscarinic antagonist (LAMA) or long-acting β2-agonist (LABA) bronchodilators and their combination are recommended for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Although the efficacy of LAMAs and LABAs has been well established through randomized controlled trials (RCTs), questions remain regarding their cardiovascular (CV) safety. Furthermore, while the safety of LAMA and LABA monotherapy has been extensively studied, data are lacking for LAMA/LABA combination therapy, and the majority of the studies that have reported on the CV safety of LAMA/LABA combination therapy were not specifically designed to assess this. Evaluation of CV safety for COPD treatments is important because many patients with COPD have underlying CV comorbidities. However, severe CV and other comorbidities are often exclusion criteria for RCTs, contributing to a lack in external validity and generalizability. Real-world observational studies are another important tool to evaluate the effectiveness and safety of COPD therapies in a broader population of patients and can improve upon the external validity limitations of RCTs. We examine what is already known regarding the CV and cerebrovascular safety of LAMA/LABA combination therapy from RCTs and real-world observational studies, and explore the advantages and limitations of data derived from each study type. We also describe an ongoing prospective, observational, comparative post-authorization safety study of a LAMA/LABA combination therapy (umeclidinium/vilanterol) and LAMA monotherapy (umeclidinium) versus tiotropium, with a focus on the relative merits of the study design.

  10. 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…

  11. 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.

  12. Safety and effectiveness of central venous catheterization in patients with cancer: prospective observational study.

    PubMed

    Kim, Hyun Jung; Yun, Jina; Kim, Han Jo; Kim, Kyoung Ha; Kim, Se Hyung; Lee, Sang-Cheol; Bae, Sang Byung; Kim, Chan Kyu; Lee, Nam Su; Lee, Kyu Taek; Park, Seong Kyu; Won, Jong-Ho; Park, Hee Sook; Hong, Dae Sik

    2010-12-01

    This study investigated the safety and effectiveness of each type of central venous catheters (CVC) in patients with cancer. We prospectively enrolled patients with cancer who underwent catheterization involving a subclavian venous catheter (SVC), peripherally inserted central venous catheter (PICC), or chemo-port (CP) in our department. From March 2007 to March 2009, 116 patients underwent 179 episodes of catheterization. A SVC was inserted most frequently (46.4%). Fifty-four complications occurred (30.1%): infection in 23 cases, malpositioning or migration of the tip in 18 cases, thrombosis in eight cases, and bleeding in five cases. Malpositioning or migration of the tip occurred more frequently with a PICC (P<0.001); infection occurred more often with a tunneled catheter (P=0.028) and was observed more often in young patients (P=0.023). The catheter life span was longer for patients with solid cancer (P=0.002) than for those with hematologic cancer, with a CP (P<0.001) than a PICC or SVC, and for an indwelling catheter with image guidance (P=0.014) than a blind procedure. In conclusion, CP is an effective tool for long term use and the fixation of tip is important for the management of PICC.

  13. 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

  14. Current Safety of Renal Allograft Biopsy With Indication in Adult Recipients: An Observational Study.

    PubMed

    Tsai, Shang-Feng; Chen, Cheng-Hsu; Shu, Kuo-Hsiung; Cheng, Chi-Hung; Yu, Tung-Min; Chuang, Ya-Wen; Huang, Shih-Ting; Tsai, Jun-Li; Wu, Ming-Ju

    2016-02-01

    Renal biopsy remains the golden standard diagnosis of renal function deterioration. The safety in native kidney biopsy is well defined. However, it is a different story in allograft kidney biopsy. We conduct this retrospective study to clarify the safety of allograft kidney biopsy with indication.All variables were grouped by the year of biopsy and they were compared by Mann-Whitney U test (for continuous variables) or Chi-square test (for categorical variables). We collected possible factors associated with complications, including age, gender, body weight, renal function, cause of uremia, status of coagulation, hepatitis, size of needle, and immunosuppressants.We recruited all renal transplant recipients undergoing allograft biopsy between January of 2009 and December of 2014. This is the largest database for allograft kidney biopsy with indication. Of all the 269 biopsies, there was no difference in occurrence among the total 14 complications (5.2%) over these 6 years. There were only 3 cases of hematomas (1.11%), 6 gross hematuria (2.23%), 1 hydronephrosis (0.37%), and 2 hemoglobin decline (0.74%). The outcome of this cohort is the best compared to all other studies, and it is even better than the allograft protocol kidney biopsy. Among all possible factors, patients with pathological report containing "medullary tissue only" were susceptible to complications (P < 0.001, 1.8 of relative risk).In modern era, this study demonstrates the safety of allograft kidney biopsy with indication. Identifying the renal capsule before biopsy to avoid puncture into medulla is the most important element to prevent complications.

  15. The fetal safety of cetirizine: an observational cohort study and meta-analysis.

    PubMed

    Etwel, F; Djokanovic, N; Moretti, M E; Boskovic, R; Martinovic, J; Koren, G

    2014-07-01

    Cetirizine, a second-generation antihistamine, is an active metabolite of hydroxyzine used in the treatment of allergies, but the data on fetal safety are inconclusive. Pregnant women who were counselled by the 'Motherisk Program' regarding cetirizine exposure were enrolled in a cohort study and compared with pregnant women counselled for non-teratogenic exposures. The objective was to measure the rate of adverse pregnancy outcomes. Subsequently, we also conducted a meta-analysis of cohort studies that examined the pregnancy outcomes of women exposed to hydroxyzine or cetirizine during pregnancy. In the cohort study, there were no significant differences in the rates of major malformations between the cetirizine exposed and comparison group. In the meta-analysis, cetirizine was not associated with increased teratogenic risk. In contrast, a meta-analysis of cetirizine and hydroxyzine studies showed a marginal association with major malformations. Cetirizine is not associated with a clinically important increase in risk of adverse fetal outcomes.

  16. Safety effects of low-cost engineering measures. An observational study in a Portuguese multilane road.

    PubMed

    Vieira Gomes, Sandra; Cardoso, João Lourenço

    2012-09-01

    Single carriageway multilane roads are not, in general, a very safe type of road, mainly because of the high number of seriously injured victims in head-on collisions, when compared with dual carriageway multilane roads, with a median barrier. In this paper the results of a study on the effect of the application of several low cost engineering measures, aimed at road infrastructure correction and road safety improvement on a multilane road (EN6), are presented. The study was developed by the National Laboratory of Civil Engineering (LNEC) for the Portuguese Road Administration and involved a comparison of selected aspects of motorized traffic behaviour (traffic volumes and speeds) measured in several sections of EN6, as well as monitoring of road safety developments in the same road. The applied low cost engineering measures allowed a reduction of 10% in the expected annual number of personal injury accidents and a 70% decrease in the expected annual number of head-on collisions; the expected annual frequency of accidents involving killed and seriously injured persons was reduced by 26%.

  17. 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

  18. Simulation study comparing exposure matching with regression adjustment in an observational safety setting with group sequential monitoring.

    PubMed

    Stratton, Kelly G; Cook, Andrea J; Jackson, Lisa A; Nelson, Jennifer C

    2015-03-30

    Sequential methods are well established for randomized clinical trials (RCTs), and their use in observational settings has increased with the development of national vaccine and drug safety surveillance systems that monitor large healthcare databases. Observational safety monitoring requires that sequential testing methods be better equipped to incorporate confounder adjustment and accommodate rare adverse events. New methods designed specifically for observational surveillance include a group sequential likelihood ratio test that uses exposure matching and generalized estimating equations approach that involves regression adjustment. However, little is known about the statistical performance of these methods or how they compare to RCT methods in both observational and rare outcome settings. We conducted a simulation study to determine the type I error, power and time-to-surveillance-end of group sequential likelihood ratio test, generalized estimating equations and RCT methods that construct group sequential Lan-DeMets boundaries using data from a matched (group sequential Lan-DeMets-matching) or unmatched regression (group sequential Lan-DeMets-regression) setting. We also compared the methods using data from a multisite vaccine safety study. All methods had acceptable type I error, but regression methods were more powerful, faster at detecting true safety signals and less prone to implementation difficulties with rare events than exposure matching methods. Method performance also depended on the distribution of information and extent of confounding by site. Our results suggest that choice of sequential method, especially the confounder control strategy, is critical in rare event observational settings. These findings provide guidance for choosing methods in this context and, in particular, suggest caution when conducting exposure matching.

  19. 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. PMID:27606015

  20. 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

  1. An observational study of inhaled-treprostinil respiratory-related safety in patients with pulmonary arterial hypertension

    PubMed Central

    Zamanian, R. T.; Levine, D. J.; Bourge, R. C.; De Souza, S. A.; Rosenzweig, E. B.; Alnuaimat, H.; Burger, C.; Mathai, S. C.; Leedom, N.; DeAngelis, K.; De Marco, T.

    2016-01-01

    Abstract Inhaled treprostinil (Tyvaso) has been shown to be a safe and effective addition to pulmonary arterial hypertension (PAH) oral therapies; however, the respiratory-related safety profile of inhaled treprostinil required further elucidation in the setting of routine clinical care. The objectives of this study were to characterize respiratory-related adverse events (AEs) associated with current or recent treatment with inhaled treprostinil and to compare the incidence of respiratory-related AEs in PAH patients treated with inhaled treprostinil with that in patients treated with other Food and Drug Administration (FDA)–approved PAH therapies. This was a long-term, prospective, observational study. All respiratory-related AEs were recorded during the study. The number of PAH patients enrolled was 1,333, 666 treated with inhaled treprostinil and 667 controls (treated with an FDA-approved PAH therapy other than inhaled treprostinil), for a total of 958 and 1,094 patient-years of exposure, respectively. In the inhaled-treprostinil group, 1,281 respiratory-related AEs were reported in 403 patients (61%), and in the control group, 1,295 respiratory-related AEs were reported in 388 patients (58%). Cough, throat irritation, nasal discomfort, and hemoptysis were the most common respiratory-related AEs (occurring in ≥2% of patients in either treatment group) that demonstrated a higher number of events per patient-year of exposure in the inhaled-treprostinil group than in the control group (risk ratio [95% confidence interval]: 1.487 [1.172–1.887], 3.777 [2.050–6.956], 2.039 [1.072–3.879], and 1.957 [1.024–3.741], respectively). Overall, inhaled treprostinil was well tolerated by PAH patients in routine clinical care, with respiratory-related AEs consistent with the known safety profile (trial registration: clinicaltrials.gov identifier: NCT01266265). PMID:27683610

  2. Efficacy and safety of super selective bronchial artery coil embolisation for haemoptysis: a single-centre retrospective observational study

    PubMed Central

    Ishikawa, Hideo; Hara, Masahiko; Ryuge, Misaki; Takafuji, Jun; Youmoto, Mihoko; Akira, Masanori; Nagasaka, Yukio; Kabata, Daijiro; Yamamoto, Kouji; Shintani, Ayumi

    2017-01-01

    Objectives Evidence on the safety and long-term efficacy of super selective bronchial artery embolisation (ssBAE) using platinum coils in patients with haemoptysis is insufficient. The objective of the present study was to evaluate the safety and the 3-year postprocedure haemoptysis-free survival rate of de novo elective ssBAE using platinum coils rather than particles for the treatment of haemoptysis. Design A single-centre retrospective observational study. Setting Hemoptysis and Pulmonary Circulation Center in Japan. Participants A total of 489 consecutive patients with massive and non-massive haemoptysis who underwent de novo elective ssBAE without malignancy or haemodialysis. Interventions ssBAE using platinum coils. All patients underwent CT angiography before the procedure for identifying haemoptysis-related arteries (HRAs) and for procedural planning. Primary and secondary outcome measures The composite of the 3-year recurrence of haemoptysis and mortality from the day of the last ssBAE session. Each component of the primary end point and procedural success defined as successful embolisation of all target HRAs were also evaluated. Results The median patient age was 69 years, and 46.4% were men. The total number of target vessels was 4 (quartile 2–7), and the procedural success rate was 93.4%. There were 8 (1.6%) major complications: 1 aortic dissection, 2 symptomatic cerebellar infarctions and 5 mediastinal haematoma cases. The haemoptysis-free survival rates were estimated by the Kaplan-Meier analysis at 86.9% (95% CI 83.7% to 90.2%) at 1 year, 79.4% (74.8% to 84.3%) at 2 years and 57.6% (45.1% to 73.4%) at 3 years. Although not statistically significant by the adjusted analysis of variance with multiple imputation of missing variables, cryptogenic haemoptysis tended to show the most favourable outcome and non-tuberculous mycobacterium showed the worst outcome (adjusted p=0.250). Conclusions We demonstrated the safety and long-term efficacy of

  3. An ambispective observational study in the safety and efficacy of posterior colporrhaphy with composite Vicryl-Prolene mesh.

    PubMed

    Lim, Y N; Rane, Ajay; Muller, R

    2005-01-01

    There is increasing evidence to show that the use of surgical meshes reduces recurrence rates of hernia repair and anterior vaginal wall prolapse. The aim of this study was to determine the safety and efficacy of posterior colporrhaphy with mesh in patients with posterior vaginal prolapse. An ambispective observational study involving 90 patients was conducted with retrospective chart review and prospective subjective and objective assessments at the end of a 1-year study period. Apart from 2 of 90 (2.2%) minor hematoma incidents, there was no other major perioperative morbidity. Prevalence of common prolapse complaints of vaginal lump sensation, constipation, defecation difficulty and dyspareunia all improved significantly postoperatively (p<0.001). Surgical correction was achieved in 27 of 31 (83.9%) at 6 months and beyond. There was no mesh infection but minor vaginal mesh protrusion was found in 7 of 90 (7.8%) patients at 6-12 weeks and 4 of 31 (12.9%) patients at 6 months and beyond. All these were treated easily with trimming without the need of mesh removal. We conclude that posterior colporrhaphy with mesh is effective in treating posterior vaginal prolapse in short term.

  4. Food safety knowledge retention study.

    PubMed

    Hislop, Nyall; Shaw, Keara

    2009-02-01

    Foodborne illness in Canada is an ongoing burden for public health and the economy. Many foodborne illnesses result from improper food handling practices. If food handlers had a greater knowledge of what causes foodborne illness, perhaps these illnesses would have less of an impact on society. This study gave researchers the opportunity to examine the current food safety knowledge of food handlers by using a standardized questionnaire. Questionnaires were distributed by environmental health officers to food handlers working in the food service industry during on-site inspections, and responses were used to evaluate immediate knowledge of key food safety issues. Both certified and noncertified food handlers were evaluated. Information also was collected on the number of years since food safety certification was achieved and the number of years experience noncertified food handlers had in the food service industry. Results indicated that certified food handlers had a greater knowledge of food safety information than did noncertified food handlers. The highest failure rates were observed among noncertified food handlers with more than 10 years of experience and less than 1 year of experience. The results support the need for mandatory food safety certification for workers in the food service industry and for recertification at least every 10 years. Although the study was not sufficiently rigorous to evaluate existing food safety courses, data collected provided valuable insight into what issues should be emphasized in existing food safety courses and which should be targeted by future food safety initiatives.

  5. 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

  6. Evaluation of Aryoseven Safety (Recombinant Activated Factor VII) in Patients with Bleeding Disorders (An Observational Post-Marketing Surveillance Study)

    PubMed Central

    Toogeh, Gholamreza; Abolghasemi, Hassan; Eshghi, Peyman; Managhchi, Mohammadreza; Shaverdi-niasari, Mohammadreza; Karimi, Katayoon; Roostaei, Samin; Emran, Neda; Abdollahi, Alireza

    2016-01-01

    Background: Recombinant activated factor VII induces hemostasis in patients with coagulopathy disorders. AryoSeven™ as a safe Iranian Recombinant activated factor VII has been available on our market. This study was performed to establish the safety of AryoSeven on patients with coagulopathy disorder. Methods: This single-center, descriptive, cross sectional study was carried out in Thrombus and Homeostasis Research Center ValiAsr Hospital during 2013-2014. Fifty one patients with bleeding disorders who received at least one dose of Aryoseven were enrolled. Patients’ demographic data and adverse effect of drug and reaction related to Aryoseven or previous usage of Recombinant activated FVII were recorded in questionnaires. Finally data were analyzed to compare side effects of Aryoseven and other Recombinant activated FVII brands. Results: Aryoseven was prescribed for 51 Patients. Of all participants with mean age 57.18+21.38 yr, 31 cases were male and 26 subjects had past history of recombinant activated FVII usage. Glanzman was the most frequent disorder followed by congenital FVII deficiency, hemophilia with inhibitors, factor 5 deficiency, acquired hemophilia, hemophilia A with inhibitor, and hemophilia A or B with inhibitor. The majority of bleeding episodes had occurred in joints. Three patients (5.9%) complained about adverse effects of Aryoseven vs. 11.5 % about adverse effects of other brands. However this difference was not significant, statistically. Conclusion: Based on monitor patients closely for any adverse events, we concluded that Aryoseven administration under careful weighing of benefit versus potential harm may comparable with other counterpart drugs. PMID:27799968

  7. Observational study of the safety of buprenorphine+naloxone in pregnancy in a rural and remote population

    PubMed Central

    Jumah, Naana Afua; Edwards, Craig; Balfour-Boehm, Jazmyn; Loewen, Kassandra; Dooley, Joseph; Gerber Finn, Lianne; Kelly, Len

    2016-01-01

    Objectives To describe the effect of in utero exposure to the buprenorphine+naloxone combination product in a rural and remote population. Setting A district hospital that services rural and remote, fly-in communities in Northwestern Ontario, Canada. Participants A retrospective cohort study was conducted of 855 mother infant dyads between 1 July 2013 and 30 June 2015. Cases included all women who had exposure to buprenorphine+naloxone during pregnancy (n=62). 2 control groups were identified; the first included women with no opioid exposure in pregnancy (n=618) and the second included women with opioid exposure other than buprenorphine+naloxone (n=159). Women were excluded if they had multiple pregnancy or if they were part of a methadone programme (n=16). The majority of women came from Indigenous communities. Outcomes The primary outcomes were birth weight, preterm delivery, congenital anomalies and stillbirth. Secondary neonatal outcomes included gestational age at delivery, Apgar scores at 1 and 5 min, NAS Score >7 and treatment for neonatal abstinence syndrome (NAS). Secondary maternal outcomes included the number of caesarean sections, postpartum haemorrhages, out of hospital deliveries and transfer of care to tertiary centres. Results No difference was found in the primary outcomes or in the Apgar score and caesarean section rate between in utero buprenorphine+naloxone exposure versus no opioid exposure in pregnancy. Compared to women taking other opioids, women taking buprenorphine+naloxone had higher birthweight babies (p=0.001) and less exposure to marijuana (p<0.001) during pregnancy. Conclusions Retrospective data suggest that there likely is no harm from taking buprenorphine+naloxone opioid agonist treatment in pregnancy. Larger, prospective studies are needed to further assess safety. PMID:27799240

  8. Efficacy and safety of growth hormone replacement therapy in Japanese adults with growth hormone deficiency: a post-marketing observational study.

    PubMed

    Shimatsu, Akira; Tai, Shigeru; Imori, Makoto; Ihara, Katsuichiro; Taketsuna, Masanori; Funai, Jumpei; Tanaka, Toshiaki; Teramoto, Akira; Irie, Minoru; Chihara, Kazuo

    2013-01-01

    This large-scale observational study examined the long-term effectiveness and safety of growth hormone (GH) replacement therapy for adult GH deficiency (GHD) in Japanese clinical practice using the Hypopituitary Control and Complications Study database. The study included 402 GHD patients for safety analyses and a subset of 209 patients (149 adult-onset and 60 childhood-onset GHD patients) who had not previously received GH replacement therapy for the efficacy analyses. Data on clinical, metabolic, quality of life (QoL) characteristics, and all adverse events (AEs) were collected at baseline (start of GH treatment), 6 months, 1 year and 2 years. Over the observation period, there were improvements from baseline in insulin-like growth factor-I standard deviation scores (P<0.001), although the changes in metabolic parameters were minimal. QoL (Short Form-36) Z-scores significantly increased from baseline in both onset-type groups for several subscale domains (P<0.05). A total of 145 (36.1%) patients experienced ≥1 AE. Common AEs were hyperlipidaemia (2.7%) and hyperinsulinaemia (2.2%). Some patients experienced recurrent hypothalamic/pituitary tumour (events per 1000 patient-years: 2.78), new benign (0.93), malignant tumour (10.28) or other new tumour (0.93), new diabetes mellitus (7.45), and new stroke (3.71). Seven patients died during the observation period. Our safety findings are inconclusive about the associations between GH replacement and AEs, although the incidence of diabetes mellitus and cardiovascular events are similar to those reported in the Japanese general population. In conclusion, the key beneficial effects of GH replacement therapy for GHD are observed in routine clinical practice in Japan.

  9. 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.

  10. 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

  11. Ferrocyanide safety study

    SciTech Connect

    Wegeng, R.S.

    1989-05-01

    The overall objective of this study is to investigate the potentially rapid reactions between the ferrocyanide-containing salts, present in the SST's, and oxidants, such as nitrate, also present in the SST's. The objective of the energetics subtask is to investigate, on a screening basis, SST operational and compositional parameters which could affect the reaction between nickel cesium ferrocyanide, the expected form of cyanide in the SST, and nitrates and/or the nitrate radiolysis product nitrite. The objective of the large-scale explosion study is to independently confirm the results of the PNL laboratory-scale experiments and to determine the explosive behavior of a large sample of ferrocyanide and oxidant. The objective of the PNL-5441 revision subtask is to revise the complexant stability report, PNL-5441, to provide a current overview of the ferrocyanide safety issue and provide information to permit establishment of guidelines for SST management. 1 fig.

  12. 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

  13. An observational feasibility study to assess the safety and effectiveness of intranasal fentanyl for radiofrequency ablations of the lumbar facet joints

    PubMed Central

    Bartoszek, Michael W; McCoart, Amy; Hong, Kyung-soo Jason; Haley, Chelsey; Highland, Krista Beth; Plunkett, Anthony R

    2017-01-01

    Purpose The purpose of the present observational, feasibility study is to assess the preliminary safety and effectiveness of intranasal fentanyl for lumbar facet radiofrequency ablation procedures. Patients and methods This cohort observational study included 23 adult patients. Systolic and diastolic blood pressures, heart rate, oxygen saturation percent, Pasero Opioid-Induced Sedation Scale score, and the Defense and Veterans Pain Rating Scale pain score were assessed prior to the procedure and intranasal fentanyl (100 μg) administration and every 15 minutes after administration, up to 60 minutes post administration. Follow-up of patient satisfaction with pain control and treatment was assessed 24 hours after discharge. The primary outcome was safety as evidenced by adverse events. Secondary outcomes included the above-mentioned vital signs and pain ratings. Results No adverse events occurred in the present study and all participants maintained an acceptable level of awareness throughout the assessment period. One-way repeated measures analyses of covariance tests with Bonferroni-adjusted means indicated that oxygen saturation, blood pressure, and heart rate changed from baseline, whereas pain scores were lower at post-administration levels compared with baseline. Finally, the majority of participants reported being satisfied with pain control and treatment. Conclusion Preliminary evidence indicates that intranasal fentanyl is safe and effective for lumbar facet radiofrequency ablation procedures. Future rigorous randomized control trials are needed to confirm the present results and to examine the effects of intranasal fentanyl on intraoperative and postoperative opioid use. PMID:28243139

  14. 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

  15. Efficacy and safety of dienogest in patients with endometriosis: A single-center observational study over 12 months

    PubMed Central

    Park, So Yun; Chae, Hee Dong; Kim, Chung-Hoon; Kang, Byung Moon

    2016-01-01

    Objective To evaluate the efficacy and safety of dienogest treatment in patients who had received dienogest for 12 months or more to treat endometriosis. Methods We analyzed the clinical data of 188 women with endometriosis who had been treated with 2 mg of dienogest once a day for 12 months or more at a single institute. We evaluated changes in endometriosis-associated pain and endometrioma size, recurrence rate, and adverse events following dienogest administration. Bone mineral density (BMD) was measured in patients who were prescribed dienogest for more than 18 months. Results Pain was significantly reduced at 12 months after dienogest medication. In those treated with dienogest due to recurrent endometrioma, the size of the endometrioma was significantly decreased at the 12-month and 18-month follow-ups. We found only one case of sonographic recurrence during dienogest administration among those who were treated postoperatively to prevent recurrence (1 of 114, 0.9%). The most common adverse drug reaction was uterine bleeding (3.2%), and other adverse events were generally tolerable and associated with low discontinuation rates (5.2%). Among the 50 patients in whom BMD was measured, 10 patients (20%) had a Z-score below the expected range for age. Conclusion The administration of dienogest for a year or more seems to be highly effective in preventing recurrence after surgery, reducing endometriosis-associated pain, and decreasing the size of recurrent endometrioma, with a favorable safety and tolerability profile. However, BMD should be checked in patients on long-term medication due to possible bone loss in some women. PMID:28090460

  16. 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…

  17. 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

  18. 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.

  19. 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

  20. Safety and effectiveness of daily teriparatide for osteoporosis in patients with severe stages of chronic kidney disease: post hoc analysis of a postmarketing observational study

    PubMed Central

    Nishikawa, Atsushi; Yoshiki, Fumito; Taketsuna, Masanori; Kajimoto, Kenta; Enomoto, Hiroyuki

    2016-01-01

    Teriparatide (recombinant 1–34 N-terminal sequence of human parathyroid hormone) for the treatment of osteoporosis should be prescribed with caution in patients with severe stages of chronic kidney disease (CKD). However, in clinical settings, physicians and surgeons who treat such patients have few available options. We sought to further explore the safety and effectiveness of teriparatide for the treatment of osteoporosis in Japanese patients with severe stages of CKD. This was a post hoc analysis of a postmarketing surveillance study that included patients with osteoporosis at high risk of fracture and stage 4 or 5 CKD. Patients received subcutaneous teriparatide 20 μg daily for up to 24 months. Safety profiles were assessed by physician-reported adverse drug reactions (ADRs). Effectiveness was assessed by measuring bone formation (via procollagen type 1 N-terminal propeptide [P1NP]), bone mineral density (BMD), and the incidence of clinical vertebral or nonvertebral fragility fractures. A total of 33 patients with severe stages of CKD (stage 4, n=30; stage 5, n=3) were included. All patients were female, and 81.8% had a history of previous fracture. No serious ADRs were recorded; a total of 4 ADRs were recorded for 4 of 33 patients. Increases in BMD and P1NP levels were observed both overall and in most individual patients. New fractures occurred in 1 patient with stage 5 CKD, but not in patients with stage 4 CKD. In this post hoc analysis conducted in Japan, teriparatide appeared to be effective for the treatment of osteoporosis in elderly female patients with severe stages of CKD, and no new safety concerns were observed. PMID:27895472

  1. Safety and Tolerability of Nafamostat Mesilate and Heparin as Anticoagulants in Leukocytapheresis for Ulcerative Colitis: Post Hoc Analysis of a Large-Scale, Prospective, Observational Study.

    PubMed

    Sawada, Koji; Ohdo, Maiko; Ino, Tomoko; Nakamura, Takashi; Numata, Toyoko; Shibata, Hiroshi; Sakou, Jun-ichi; Kusada, Masahiro; Hibi, Toshifumi

    2016-04-01

    Nafamostat mesilate is the first anticoagulant of choice for leukocytapheresis (LCAP) with a Cellsorba E column for treating ulcerative colitis (UC). However, because of complications, mainly due to allergy to nafamostat mesilate, heparin may be used as a substitute. To evaluate the safety and tolerability of nafamostat mesilate and heparin as anticoagulants in LCAP for UC, we conducted post hoc analysis of data from a large-scale, prospective, observational study of LCAP, which was conducted at 116 medical facilities in Japan between May 2010 and December 2012. Of 832 patients included in this analysis, nafamostat mesilate and heparin were used in 676 (81.3%) and 113 (13.6%), respectively. There were no significant differences in the incidence of adverse reactions (8.6% vs. 7.1%) and intrafilter pressure increases (12.7% vs. 16.8%) between the nafamostat mesilate and heparin groups. Adverse reactions of hemorrhage or blood pressure decreases associated with heparin use were not observed. There were no significant differences in rates of clinical remission (69.1% vs. 68.1%) and mucosal healing (62.9% vs. 63.6%) between the nafamostat mesilate and heparin groups. Thus, the safety and tolerability were comparable in the nafamostat mesilate and heparin groups, indicating that both nafamostat mesilate and heparin can be well tolerated as anticoagulants in LCAP for UC.

  2. Mindfulness-based stress reduction in patients with interstitial lung diseases: a pilot, single-centre observational study on safety and efficacy

    PubMed Central

    Sgalla, Giacomo; Cerri, Stefania; Ferrari, Roberto; Ricchieri, Maria Pia; Poletti, Stefano; Ori, Margherita; Garuti, Martina; Montanari, Gloria; Luppi, Fabrizio; Petropulacos, Kyriakoula; Richeldi, Luca

    2015-01-01

    Background Chronic, progressive respiratory symptoms are associated with great psychological and emotional impact in patients suffering from interstitial lung disease (ILD). This single-centre pilot study evaluated for the first time the safety, feasibility and efficacy of a Mindfulness Based Stress Reduction Program (MBSR) in a group of patients with ILD. Methods Prospective observational study set in a university hospital ILD outpatient clinic. Nineteen patients with different ILDs were recruited 2 months prior to the start of the 8-week MBSR program and followed up for 12 months. Primary outcomes were program safety and feasibility, while secondary outcomes were changes in moods and stress (assessed by Profile Of Mood State (POMS) and Perceived Stress Scale (PSS) questionnaires), symptoms (Shortness Of Breath (SOB) and Cough And Sputum Assessment (CASA-Q) questionnaires), lung function and exercise tolerance at 12 months. Results Two patients (10.5%) dropped out in the observational period before the start of the MBSR intervention because of non-respiratory causes. All 17 patients who entered the 8-week MBSR program managed to complete it with an adherence average of eight sessions of nine. No adverse events related to the mindfulness training were reported. Statistically significant improvements in the POMS total score and in several individual items of POMS and PSS were observed throughout the study. However, respiratory questionnaire scores, lung function and exercise tolerance did not show a significant difference over time. Conclusions An MBSR program appears to be safe and feasible in patients with ILD, and might affect perceived moods and stress producing a positive and lasting improvement in several stress-related negative domains. These findings pave the way to larger (possibly multicentre), randomised, controlled confirmatory trials. PMID:25806113

  3. 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.

  4. Efficacy and safety of salvage therapy using Carfilzomib for relapsed or refractory multiple myeloma patients: a multicentre retrospective observational study.

    PubMed

    Muchtar, Eli; Gatt, Moshe E; Rouvio, Ory; Ganzel, Chezi; Chubar, Evgeni; Suriu, Celia; Tadmor, Tamar; Shevetz, Olga; Lavi, Noa; Shochat, Tzippy; Cohen, Yael C; Avivi, Irit; Raanani, Pia; Magen, Hila

    2016-01-01

    Carfilzomib has been established in previous years as a treatment for patients with relapsed and/or refractory multiple myeloma (RR-MM). A retrospective multicentre study to evaluate the clinical use of carfilzomib for RR-MM outside of a clinical trial setting was conducted by our group. One hundred and thirty-five patients were included. All patients had been previously exposed to bortezomib and 93% had also been treated with lenalidomide. The vast majority of patients received carfilzomib as part of a two- or three-drug combination. The overall response rate was 47·2%. Multivariate analysis revealed bortezomib resistance, lenalidomide resistance and albumin <35 g/l to negatively impact the likelihood of achieving response. The median duration of response was 8·4 months, and was significantly higher in patients receiving three-drug combination and patients presenting without extramedullary disease. The median progression-free survival and overall survival for the entire cohort was 4·9 months (95% confidence interval [CI] 3·8-6·4) and 12·2 months (95% CI 9-not reached), respectively. Toxicity was manageable, although treatment-related death was seen in 5% of patients. In the setting of progressive multiple myeloma, carfilzomib in a combination regimens yields effective results with a manageable toxicity.

  5. Observational study on quality of life, safety, and effectiveness of first-line cetuximab plus chemotherapy in KRAS wild-type metastatic colorectal cancer patients: the ObservEr Study.

    PubMed

    Pinto, Carmine; Di Fabio, Francesca; Rosati, Gerardo; Lolli, Ivan R; Ruggeri, Enzo M; Ciuffreda, Libero; Ferrari, Daris; Lo Re, Giovanni; Rosti, Giovanni; Tralongo, Paolo; Ferrara, Raimondo; Alabiso, Oscar; Chiara, Silvana; Ianniello, Giovanni P; Frassoldati, Antonio; Bilancia, Domenico; Campanella, Giovanna A; Signorelli, Carlo; Racca, Patrizia; Benincasa, Elena; Stroppolo, Maria Elena; Di Costanzo, Francesco

    2016-11-01

    Cetuximab improves efficacy when added to chemotherapy for metastatic colorectal cancer (mCRC). Effective management of skin reactions from cetuximab improves quality of life (QoL), and treatment compliance in clinical trials. No data are available from real-world settings. The ObservEr observational, multicenter, prospective study evaluated QoL, the incidence of skin reactions, and management of chemotherapy plus cetuximab in first-line for mCRC. The primary endpoint was QoL measured with the Dermatology Life Quality Index (DLQI) and EORTC QLQ-C30. Secondary endpoints were the incidence of skin and serious adverse events, median overall and progression-free survival, tumor response, and resection rates. Between May 2011 and November 2012, 228 patients with KRASwt mCRC were enrolled at 28 Italian centers, 225 evaluable, median age 65 years. QoL did not change during treatment and was not affected by the choice of prophylactic or reactive skin management. The incidence of cetuximab-specific grade ≥3 skin reactions was 14%, with no grade 4/5 events. Skin reactions correlated with survival (P = 0.016), and their incidence was influenced by chemotherapy regimen (oxaliplatin vs. irinotecan-Incidence rate ratio [IRR] 1.72, P < 0.0001) and gender (male vs. female-IRR 1.38, P = 0.0008). Compliance at first postbaseline evaluation was 97.75%. Median overall survival was 23.6 months, median progression-free survival 8.3 months. Cetuximab plus chemotherapy did not compromise QoL in the routine clinical setting when patients receive close monitoring plus prophylactic or reactive management of skin reactions. We observed the same correlation between overall survival (OS) and skin reactions reported in controlled clinical trials, also in this setting.

  6. 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

  7. 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

  8. Efficacy and Safety of the WATCHMAN Left Atrial Appendage System for Stroke Prevention in Chinese Patients with Nonvalvular Atrial Fibrillation: A Single-center, Prospective, Observational Study

    PubMed Central

    Huang, Wei-Ping; Zhang, Yong-Hua; He, Lei; Su, Xi; Yang, Xin-Wei; Guo, Zai-Xiong

    2017-01-01

    Background: In patients with nonvalvular atrial fibrillation (NVAF), embolic stroke is thought to be associated with left atrial appendage (LAA) thrombi. The WATCHMAN LAA Occlusion Device has been shown to be noninferior to conventional oral anticoagulation with warfarin for stroke prevention in patients with NVAF. This study aimed to evaluate the procedural feasibility, safety and 12-month outcomes of the WATCHMAN LAA Occlusion Device in NVAF patients with high risk for stroke in China. Methods: The clinical data of 106 NVAF patients, who were consecutively underwent LAA closure with the WATCHMAN Device between April 2014 and May 2015, were collected. Patients were followed up at 1, 3, 6, and 12 months after discharge. A transesophageal echocardiograph was performed at 45 days after implantation and repeated in case of an unexpected event during the follow-up period. Results: This study included 106 NVAF patients with a mean age of 64.2 ± 8.6 years (ranging from 50 to 88 years), and the mean CHA2DS2-VASc score of all patients was 3.6 ± 1.6 (ranging from 2 to 9). Among those 106 NVAF patients, 100 (94.3%) patients were implanted with the device successfully. The procedural success rate was 94.3% (100/106), and the occlusion rate was 100.0% (100/100). There were one tamponade, one ischemic stroke, and eight minor pericardial effusions during hospitalization. During 12-month follow-up period, two patients developed a thrombus layer on the device that resolved with additional anticoagulation: one with visible device-thrombus experienced transient ischemic stroke, and one had a hemorrhagic stroke. There were no deaths in this study. The overall survival rate was 100.0%, and nonmajor adverse event rate was 95.0% (95/100). In this study, the expected annual rate of ischemic stroke risk in these patients according to the CHA2DS2-VASc score was 4.0%, while the observed ischemic stroke rate was 2.0% per year. Conclusions: LAA closure with the WATCHMAN Device was feasible

  9. Glycemic control and safety in Chinese patients with type 2 diabetes mellitus who switched from premixed insulin to insulin glargine plus oral antidiabetics: a large, prospective, observational study.

    PubMed

    Zhang, Bo; Zhao, Jing; Yang, Wenying

    2017-03-01

    In some circumstances, the premixed insulin should be switched to alternative therapy. The effectiveness and the safety of switching from premixed insulin to insulin glargine plus oral antidiabetic drugs (OADs) in Chinese patients with type 2 diabetes mellitus (T2DM) have not been clarified and, hence, will be assessed in this study. Chinese patients with T2DM (2013 men and women aged 18-75 years) who had received premixed insulin ± OADs for ≥3 months with glycated hemoglobin (HbA1c) ≤ 10% were enrolled in a prospective, observational study conducted at 53 hospitals across China. At baseline and at the discretion of the physician, patients switched from premixed insulin to insulin glargine plus OADs. Changes in HbA1c, fasting plasma glucose (FPG), 2-hour postprandial glucose (PPG), treatment satisfaction, and the incidence of hypoglycemia were assessed for 16 weeks. In total, 1850 patients completed the study. Mean HbA1c level for the group decreased significantly (from 7.8% ± 1.2% at week 1 to 7.0% ± 1.0% at week 16; P < .0001), and 55.2% of patients achieved HbA1c < 7% at week 16. Mean FPG and 2-hour PPG decreased significantly (-1.4 ± 2.2 and -2.1 ± 3.9 mmol/L, respectively; both P < .0001), whereas patient satisfaction improved significantly. Adverse events were reported in 18.7% of patients. Chinese patients with T2DM who switched from premixed insulin to insulin glargine plus OADs achieved significantly improved glycemic control and treatment satisfaction with a low incidence of hypoglycemia. Patients who are most likely to achieve the HbA1c target less than 7% are younger, have shorter disease duration, and have lower baseline HbA1c and FPG levels.

  10. 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.

  11. 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

  12. Nanotechnology Safety Self-Study

    SciTech Connect

    Grogin, Phillip W.

    2016-03-29

    Nanoparticles are near-atomic scale structures between 1 and 100 nanometers (one billionth of a meter). Engineered nanoparticles are intentionally created and are used in research and development at Sandia National Laboratories (SNL) and Los Alamos National Laboratory (LANL). This course, Nanotechnology Safety Self-Study, presents an overview of the hazards, controls, and uncertainties associated with the use of unbound engineered nanoscale particles (UNP) in a laboratory environment.

  13. Distracted Biking: An Observational Study

    PubMed Central

    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 (US). 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 four high traffic intersections in Boston during various peak commuting hours for two types of distractions: auditory (ear buds/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=0.0003) 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 13:30-15:00). Distracted bicycling is a prevalent safety concern in the city of Boston, as almost one-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

  14. 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.

  15. Safety study - oversight of rail rapid-transit safety

    SciTech Connect

    Not Available

    1991-07-23

    Annually, about 1.8 billion passengers ride on the rail rapid transit systems operating in the United States. Although this form of transportation is generally safe, the potential exists for a substantial loss of life in the event of a collision, derailment, fire, or other emergency. The safety study examines the adequacy of current oversight of rail rapid transit safety. The safety issues discussed are the effectiveness of current oversight activities exercised by the States in which rail rapid transit systems are operating; the preciseness of rail rapid transit accident/injury data; and the Federal Government's role in the oversight of rail rapid transit safety. Recommendations concerning these issues were made to the Department of Transportation, the Urban Mass Transportation Administration, the District of Columbia, and States in which rail rapid transit systems are currently operating.

  16. Safety, efficacy and immunogenicity of switching from innovator to biosimilar infliximab in patients with spondyloarthritis: a 6-month real-life observational study.

    PubMed

    Benucci, Maurizio; Gobbi, Francesca Li; Bandinelli, Francesca; Damiani, Arianna; Infantino, Maria; Grossi, Valentina; Manfredi, Mariangela; Parisi, Simone; Fusaro, Enrico; Batticciotto, Alberto; Sarzi-Puttini, Piercarlo; Atzeni, Fabiola; Meacci, Francesca

    2016-07-23

    Biosimilar infliximab (INX) was recently approved by the European Medicine Agency for the treatment of rheumatoid arthritis, ankylosing spondylitis (AS), Crohn's disease, ulcerative colitis, psoriatic arthritis (PsA), and psoriasis on the grounds that its pharmacokinetics, safety, and efficacy were comparable to those of innovator INX. The aim of this study was to investigate the real-life efficacy, safety, and immunogenicity of switching from innovator to biosimilar INX in patients with spondyloarthritis (SpA). Forty-one patients attending three Italian rheumatology centres with a previous diagnosis of SpA and clinically inactive or moderate disease activity (ASDAS-CRP < 2.1; 22 with AS, five with enteropathic arthritis, 10 with PsA, and four with undifferentiated SpA), who had been treated for more than 6 months with innovator INX in accordance with the ASAS/EULAR guidelines, were switched to biosimilar INX for pharmaco-economic reasons (Tuscany Law No. 450 of 7 April 2015) and followed up for 6 months. A record was kept of their BASDAI, BASFI, ASDAS-CRP, DAS28-CRP (in the presence of peripheral disease), MASES, VAS pain scores, the duration of morning stiffness, and adverse events (AEs). At the time of the switch, the patients had a median age of 50.9 years (range 23-80), a median disease duration of 124.5 months (range 14-372), and a median duration of treatment with innovator INX of 73.7 months (range 6-144). After 6 months of biosimilar INX therapy, there were no statistical differences in their median BASDAI (2.73 ± 1.5 vs. 2.6 ± 1.3, p = .27), BASFI (2.34 ± 1.3 vs. 2.17 ± 1.2, p = 0.051), ASDAS-CRP (1.35 ± 0.3 vs. 1.28 ± 0.2, p = 0.24), DAS28-CRP (2.66 ± 0.67 vs. 2.67 ± 0.35, p = 0.92), MASES (0.35 ± 0.7 vs. 0.17 ± 0.4, p = 0.08), or VAS pain scores (18 ± 14.7 vs. 16.7 ± 11.3, p = 0.55), whereas the median duration of morning stiffness had significantly decreased (7.2 ± 6.9 vs. 5.8 ± 6, p = 0

  17. 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.

  18. Keys to Successful Diabetes Self-Management for Uninsured Patients: Social Support, Observational Learning, and Turning Points A Safety Net Providers’ Strategic Alliance Study

    PubMed Central

    Hanahan, Melissa A.; Werner, James J.; Tomsik, Phillip; Weirich, Stephen A.; Reichsman, Ann; Navracruz, Lisa; Clemons-Clark, Terri; Cella, Peggi; Terchek, Joshua; Munson, Michelle R.

    2015-01-01

    Objective To determine how medically uninsured patients with limited material resources successfully manage diabetes. Methods Clinicians at 5 safety net practices enrolled uninsured adult patients (N=26) with prior diagnosis of diabetes for 6 months or longer. Patients were interviewed about enabling factors, motivations, resources, and barriers. Chart reviews and clinician surveys supplemented interview data. Interview, survey, and chart review data were analyzed and findings were summarized. Results Two distinct groups of patients were investigated: 1) “successful,” defined as those with an HbA1c of ≤7% or a recent improvement of at least 2% (n=17); and 2) “unsuccessful,” defined as patients with HbA1c of ≥9% (n=9) without recent improvement. In comparison to unsuccessful patients, successful patients more often reported having friends or family with diabetes, sought information about the disease, used evidence-based self-management strategies, held an accurate perception of their own disease control, and experienced “turning point” events that motivated increased efforts in disease management. Conclusions Uninsured safety net patients who successfully managed diabetes learned from friends and family with diabetes and leveraged disease-related events into motivational turning points. It may be beneficial for clinicians to incorporate social learning and motivational enhancement into diabetes interventions to increase patients’ motivation for improved levels of self-management. PMID:21671529

  19. An observational cohort study of bevacizumab and chemotherapy in metastatic colorectal cancer patients: safety and efficacy with analysis by age group.

    PubMed

    Tahover, Esther; Hubert, Ayala; Temper, Mark; Salah, Azzam; Peretz, Tamar; Hamburger, Tamar; Uziely, Beatrice

    2015-03-01

    Bevacizumab improves survival when added to chemotherapy in metastatic colorectal cancer (mCRC). We assessed the safety and efficacy of bevacizumab in mCRC patients ≥70 years old (YO) vs. those <70 YO. mCRC patients treated from 2005-2012 who received chemotherapy (physician's choice) plus bevacizumab were included. The primary end point was safety; secondary objectives were progression-free survival (PFS) and overall survival (OS). Data was collected retrospectively. Three-hundred eight patients (92 ≥70 YO, 216 <70 YO) with 20.5 month median follow-up were included. Of the patients, 1.9 % died due to bevacizumab-related adverse effects; all were <70 YO. Grades 3-5 adverse events of interest for bevacizumab in patients ≥70 YO included hypertension (37.0 %), venous thromboembolism (6.5 %), wound-healing complications (5.4 %), bleeding (7.6 %), fistula (4.3 %), arterial thromboembolism (3.3 %), congestive heart failure (2.2 %), and proteinuria (grades 1-2 only, 14.1 %). Treatment was stopped due to adverse effects in 6.0 % of older patients. Older patients had significantly more ischemic heart disease and hypertension at baseline, and were treated less with FOLFOX and more with 5FU/LV monotherapy; nevertheless, OS and PFS were similar in younger and older patients. Compared to younger patients, in older patients, rates of proteinuria (all grades 1-2) were significantly higher (14.1 vs. 5.6 %, p=0.012) and rates of treatment-related hypertension (grades 3-5) were marginally higher (37 vs. 25.9 %, p=0.053); rates of other adverse events were similar in the two groups. In our patient population, bevacizumab was safe and effective in older as well as younger patients.

  20. White Paper on studying the safety of the childhood immunization schedule in the Vaccine Safety Datalink.

    PubMed

    Glanz, Jason M; Newcomer, Sophia R; Jackson, Michael L; Omer, Saad B; Bednarczyk, Robert A; Shoup, Jo Ann; DeStefano, Frank; Daley, Matthew F

    2016-02-15

    While the large majority of parents in the U.S. vaccinate their children according to the recommended immunization schedule, some parents have refused or delayed vaccinating, often citing safety concerns. In response to public concern, the U.S. Institute of Medicine (IOM) evaluated existing research regarding the safety of the recommended immunization schedule. The IOM concluded that although available evidence strongly supported the safety of the currently recommended schedule as a whole, additional observational research was warranted to compare health outcomes between fully vaccinated children and those on a delayed or alternative schedule. In addition, the IOM identified the Vaccine Safety Datalink (VSD) as an important resource for conducting this research. Guided by the IOM findings, the Centers for Disease Control and Prevention (CDC) commissioned a White Paper to assess how the VSD could be used to study the safety of the childhood immunization schedule. Guided by subject matter expert engagement, the resulting White Paper outlines a 4 stage approach for identifying exposure groups of undervaccinated children, presents a list of health outcomes of highest priority to examine in this context, and describes various study designs and statistical methods that could be used to analyze the safety of the schedule. While it appears feasible to study the safety of the recommended immunization schedule in settings such as the VSD, these studies will be inherently complex, and as with all observational studies, will need to carefully address issues of confounding and bias. In light of these considerations, decisions about conducting studies of the safety of the schedule will also need to assess epidemiological evidence of potential adverse events that could be related to the schedule, the biological plausibility of an association between an adverse event and the schedule, and public concern about the safety of the schedule.

  1. 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

  2. A Randomized, Controlled, Observer-Blinded Phase 1 Study of the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine With or Without Alum Adjuvant

    PubMed Central

    Langley, Joanne M.; Aggarwal, Naresh; Toma, Azhar; Halperin, Scott A.; McNeil, Shelly A.; Fissette, Laurence; Dewé, Walthere; Leyssen, Maarten; Toussaint, Jean-François; Dieussaert, Ilse

    2017-01-01

    Background. Respiratory syncytial virus (RSV) is a leading cause of childhood bronchiolitis and pneumonia, particularly in early infancy. Immunization of pregnant women could boost preexisting immune responses, providing passive protection to newborns through placental transfer of anti-RSV antibody. Methods. In this first-in-humans clinical trial of a purified recombinant RSV protein F vaccine engineered to preferentially maintain prefusion conformation (RSV-PreF), 128 healthy men 18–44 years old were randomized to one dose of a RSV-PreF vaccine containing 10, 30, or 60 µg of RSV-PreF antigen, with or without alum adjuvant, or control, and followed for one year for safety and immunogenicity outcomes. Results. Injection site pain was the most common adverse event, reported by up to 81.3% of participants. The highest RSV neutralizing antibody responses were in the 30 µg RSV-PreF/alum, 60 µg RSV-PreF/alum, and 60 µg RSV-PreF/nonadjuvant groups. Responses were evident on day 7, and 30 days after vaccination these participants had RSV-A neutralizing antibody titers of ≥1:512, and >70% had titers of 1:1024, with titers increasing by 3.2–4.9 fold. Responses remained high on day 60 but waned on days 180 and 360. Conclusions. The RSV-PreF vaccine elicited rapid RSV neutralizing antibody responses in healthy young men, with an acceptable adverse event profile. PMID:27694633

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

    PubMed Central

    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

    2016-01-01

    Abstract 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

  4. 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.

  5. Stennis Space Center observes 2009 Safety and Health Day

    NASA Technical Reports Server (NTRS)

    2009-01-01

    Sue Smith, a medical clinic employee at NASA's John C. Stennis Space Center, takes the temperature of colleague Karen Badon during 2009 Safety and Health Day activities Oct. 22. Safety Day activities included speakers, informational sessions and a number of displays on safety and health issues. Astronaut Dominic Gorie also visited the south Mississippi rocket engine testing facility during the day to address employees and present several Silver Snoopy awards for outstanding contributions to flight safety and mission success. The activities were part of an ongoing safety and health emphasis at Stennis.

  6. Liraglutide effect and action in diabetes-In (LEAD-In): A prospective observational study assessing safety and effectiveness of liraglutide in patients with type 2 diabetes mellitus treated under routine clinical practice conditions in India

    PubMed Central

    Wangnoo, Subhash Kumar; Kumar, Surender; Bhattacharyya, Arpandev; Tripathi, Sudhir; Akhtar, Shahid; Shetty, Raman; Ghosal, Samit

    2016-01-01

    Background: This 26-week, open-label observational study assessed the incidence and type of adverse events (AEs) associated with liraglutide use according to the standard clinical practice settings and the local label in India. Materials and Methods: A total of 1416 adults with type 2 diabetes (T2D) treated with liraglutide in 125 sites across India were included in the study. Participants were newly diagnosed or already receiving antidiabetic medications. Safety and efficacy data were collected at baseline and at approximately weeks 13 and 26. The primary outcome was incidence and type of AEs while using liraglutide, with events classified by Medical Dictionary for Regulatory Activities system organ class and preferred term. The secondary objective was to assess other clinical parameters related to effective T2D management. Results: Twenty AEs, predominately gastrointestinal, were reported in 1.3% of the study population in scheduled visits up to week 26. No serious AEs, including death, were reported. Hypoglycemic episodes were reported in 7.3% of participants at baseline and 0.7% at week 26. No major hypoglycemic events were reported up to week 26 (baseline: 0.4%). Glycated hemoglobin was reduced from baseline (8.8 ± 1.3%) to week 26 by 1.6 ± 1.1% (P < 0.0001); significant improvements in fasting blood glucose, and 2-h postprandial blood glucose (post-breakfast, -lunch, and -dinner) were also observed. Mean body weight decreased by 8.1 ± 6.5 kg from baseline (92.5 ± 14.6 kg; P < 0.0001). Conclusions: From the number of AEs reported, it is suggested that liraglutide was well tolerated in subjects with T2D treated under standard clinical practice conditions in India. Liraglutide was effective, and no new safety concerns were identified. PMID:27867889

  7. Gender differences in the adverse events’ profile registered in seven observational studies of a wide gender-medicine (MetaGeM) project: the MetaGeM safety analysis

    PubMed Central

    Colombo, Delia; Zagni, Emanuela; Nica, Mihaela; Rizzoli, Sara; Ori, Alessandra; Bellia, Gilberto

    2016-01-01

    Background MetaGeM is a wide gender-medicine project comprising post hoc and meta-analyses by gender of clinical outcomes, therapeutic approaches, and safety data from previously conducted observational studies to explore possible gender differences in real-life clinical settings. We report the results of the safety meta-analysis of seven MetaGeM studies, evaluating gender differences in adverse event (AE) incidence and severity. Methods Data were collected between February 2002 and July 2013. Male and female patients were compared for the main safety variables, using Student’s t-test, χ2 test, or Fisher’s exact test as appropriate. As supportive analysis, a logistic regression model was estimated to evaluate associations between gender and outcome. Results In total, 4,870 patients (46% females, 54% males) were included in the analysis; age was higher for females (mean ± standard deviation 61.2±18.3 years) than males (56.3±16.6 years). Overall, 264 AEs were reported (59.1% in males). There were no significant gender differences in the percentage of patients with at least one AE: 3.0% for females versus 3.9% for males, χ2 test P>0.05. According to the logistic regression model results, no association between gender and AEs occurrence seems to exist. A statistically significant gender difference in the percentage of drug-related AEs emerged (37.6% in females vs 20.8% in males, χ2 P=0.0039). Slightly significantly more AEs in females were addressed with treatment compared with males (78.1% vs 66.7%, χ2 P=0.0485). Total serious AEs (SAEs) were 47 (72% in males). The frequency of patients with ≥1 SAE was 0.6% in females versus 1.2% in males (χ2 test P=0.0246). Conclusion This safety analysis on a large sample of almost 5,000 patients with different diseases and treated with a wide range of different drugs provides a useful overview on possible gender differences in drug tolerability, which may be helpful in more accurately designing future clinical trials

  8. Flammable Gas Safety Self-Study 52827

    SciTech Connect

    Glass, George

    2016-03-17

    This course, Flammable Gas Safety Self-Study (COURSE 52827), presents an overview of the hazards and controls associated with commonly used, compressed flammable gases at Los Alamos National Laboratory (LANL).

  9. 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.

  10. 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.

  11. The implementation of nice guidance on venous thromboembolism risk assessment and prophylaxis: a before-after observational study to assess the impact on patient safety across four hospitals in England

    PubMed Central

    2013-01-01

    Background Venous thromboembolism (VTE) is a major cause of morbidity and mortality in hospitalised patients. VTE prevention has been identified as a major health need internationally to improve patient safety. A National Institute for Health and Clinical Excellence (NICE) guideline was issued in February 2010. Its key priorities were to assess patients for risk of VTE on admission to hospital, assess patients for bleeding risk and evaluate the risks and benefits of prescribing VTE prophylaxis. The aim of this study was to evaluate the implementation of NICE guidance and its impact on patient safety. Methods A before-after observational design was used to investigate changes in VTE risk assessment documentation and inappropriate prescribing of prophylaxis between the year prior to (2009) and the year following (2010) the implementation of NICE guidance, using data from a 3-week period during each year. A total of 408 patients were sampled in each year across four hospitals in the NHS South region. Results Implementation strategies such as audit, education and training were used. The percentage of patients for whom a VTE risk assessment was documented increased from 51.5% (210/408) in 2009 to 79.2% (323/408) in 2010; difference 27.7% (95% CI: 21.4% to 33.9%; p < 0.001). There was little evidence of change in the percentage who were prescribed prophylaxis amongst patients without a risk assessment (71.7% (142/198) in 2009 and 68.2% (58/85) in 2010; difference −3.5% (95% CI: -15.2% to 8.2%; p =0.56) nor the percentage who were prescribed low molecular weight heparin amongst patients with a contraindication (14% (4/28) in 2009 and 15% (6/41) in 2010; RD = 0.3% (95% CI: -16.5% to 17.2%; p =0.97). Conclusions The documentation of risk assessment improved following the implementation of NICE guidance; it is questionable, however, whether this led to improved patient safety with respect to prescribing appropriate prophylaxis. PMID:23734903

  12. 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…

  13. Safety and effectiveness of a 12-week course of sofosbuvir and simeprevir ± ribavirin in HCV-infected patients with or without HIV infection: a multicentre observational study.

    PubMed

    Bruno, Giuseppe; Saracino, Annalisa; Fabrizio, Claudia; Scudeller, Luigia; Milano, Eugenio; Dell'Acqua, Raffaele; Ladisa, Nicoletta; Fasano, Massimo; Minniti, Salvatore; Buccoliero, Giovanni; Tartaglia, Alessandra; Giammario, Adele; Milella, Michele; Angarano, Gioacchino

    2017-03-01

    The combination of sofosbuvir and simeprevir ± ribavirin (SOF + SMV ± RBV) for hepatitis C virus (HCV) treatment has been associated with high rates of sustained virological response (SVR). Few data are available regarding this regimen in HIV/HCV co-infected patients. This study evaluated the effectiveness and safety of a 12-week course of SOF + SMV ± RBV in a cohort of HCV monoinfected and HIV/HCV co-infected individuals. HCV-infected patients, with or without HIV infection, receiving a 12-week course of SOF + SMV ± RBV in four Italian centres from February to October 2015, were included in this retrospective observational study. Clinical and biochemical data were retrieved for all patients. A total of 88 individuals were evaluated: 29 (33.0%) HIV/HCV co-infected and 59 (67.0%) monoinfected. Most patients were males with HCV genotype 1b (62.5%) and 1a (25%) infection. RBV was used in 41 HCV monoinfected and 6 HIV/HCV co-infected patients. Cirrhosis was found in 67 patients (76.1%). The most common adverse events (AEs) were rash and/or pruritus (23.9%), fatigue (13.6%) and anaemia (9.1%). Serious AEs occurred in three patients (3.4%). No treatment discontinuations were observed. RBV use was associated with multiple AEs (P = 0.02). An overall SVR12 of 93.2% was achieved; 96.6% in HCV monoinfected and 86.2% in HIV/HCV co-infected individuals, without significance both in univariate (P = 0.09) and multivariate analyses (P = 0.12). A baseline platelet count ≥90 000/mm(3) was associated with higher rates of SVR (P = 0.005). A 12-week course of SOF + SMV ± RBV was associated with good safety and high SVR12 rate both in HCV monoinfected and HIV-HCV co-infected individuals.

  14. 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

  15. Studies on Labour Safety in Construction Sites

    PubMed Central

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

    2015-01-01

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

  16. Studies on Labour Safety in Construction Sites.

    PubMed

    Kanchana, S; Sivaprakash, P; Joseph, Sebastian

    2015-01-01

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

  17. 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.

  18. Pressure Safety: Advanced Self-Study 30120

    SciTech Connect

    Glass, George

    2016-02-29

    Pressure Safety Advance Self-Study (Course 30120) consists of an introduction, five modules, and a quiz. To receive credit in UTrain for completing this course, you must score 80% or better on the 15-question quiz (check UTrain). Directions for initiating the quiz are appended to the end of this training manual. This course contains several links to LANL websites. UTrain might not support active links, so please copy links into the address line in your browser.

  19. 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

  20. 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.

  1. 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

  2. Running a hospital patient safety campaign: a qualitative study

    PubMed Central

    Ozieranski, Piotr; Robins, Victoria; Minion, Joel; Willars, Janet; Wright, John; Weaver, Simon; Martin, Graham P.; Woods, Mary Dixon

    2017-01-01

    Purpose Research on patient safety campaigns has mostly concentrated on large-scale multi-organisation efforts, yet locally led improvement is increasingly promoted. The purpose of this paper is to characterise the design and implementation of an internal patient safety campaign at a large acute National Health Service hospital trust with a view to understanding how to optimise such campaigns. Design/methodology/approach The authors conducted a qualitative study of a campaign that sought to achieve 12 patient safety goals. The authors interviewed 19 managers and 45 frontline staff, supplemented by 56 hours of non-participant observation. Data analysis was based on the constant comparative method. Findings The campaign was motivated by senior managers’ commitment to patient safety improvement, a series of serious untoward incidents, and a history of campaign-style initiatives at the trust. While the campaign succeeded in generating enthusiasm and focus among managers and some frontline staff, it encountered three challenges. First, though many staff at the sharp end were aware of the campaign, their knowledge, and acceptance of its content, rationale, and relevance for distinct clinical areas were variable. Second, the mechanisms of change, albeit effective in creating focus, may have been too limited. Third, many saw the tempo of the campaign as too rapid. Overall, the campaign enjoyed some success in raising the profile of patient safety. However, its ability to promote change was mixed, and progress was difficult to evidence because of lack of reliable measurement. Originality/value The study shows that single-organisation campaigns may help in raising the profile of patient safety. The authors offer important lessons for the successful running of such campaigns. PMID:25241600

  3. 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.

  4. 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.

  5. 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...

  6. 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...

  7. 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: This notice was published in the Federal Register...

  8. 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

    ... 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...

  9. 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

    ... 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. Designing Effective Safety Signs, Based on a Study of Recall for Safety Signs.

    ERIC Educational Resources Information Center

    Berry, Dennis W.

    Aside from direct supervision at a recreational facility, safety signs, if designed properly, are the most effective approach to facility safety. This study was conducted to investigate the effectiveness of various sign designs: (l) multiple concepts with text; (2) single concept with text; and (3) single concept with graphics. A discussion of…

  11. A prospective study of patient safety incidents in gastrointestinal endoscopy

    PubMed Central

    Matharoo, Manmeet; Haycock, Adam; Sevdalis, Nick; Thomas-Gibson, Siwan

    2017-01-01

    Background and study aims Medical error occurs frequently with significant morbidity and mortality. This study aime to assess the frequency and type of endoscopy patient safety incidents (PSIs). Patients and methods A prospective observational study of PSIs in routine diagnostic and therapeutic endoscopy was undertaken in a secondary and tertiary care center. Observations were undertaken within the endoscopy suite across pre-procedure, intra-procedure and post-procedure phases of care. Experienced (Consultant-level) and trainee endoscopists from medical, surgical, and nursing specialities were included. PSIs were defined as any safety issue that had the potential to or directly adversely affected patient care: PSIs included near misses, complications, adverse events and “never events”. PSIs were reviewed by an expert panel and categorized for severity and nature via expert consensus. Results One hundred and forty procedures (92 diagnostic, 48 therapeutic) over 37 lists (experienced operators n = 25, trainees n = 12) were analyzed. One hundred forty PSIs were identified (median 1 per procedure, range 0 – 7). Eighty-six PSIs (61 %) occurred in 48 therapeutic procedures. Zero PSIs were detected in 13 diagnostic procedures. 21 (15 %) PSIs were categorized as severe and 12 (9 %) had the potential to be “never events,” including patient misidentification and wrong procedure. Forty PSIs (28 %) were of intermediate severity and 78 (56 %) were minor. Oxygen monitoring PSIs occurred most frequently. Conclusion This is the first study documenting the range and frequency of PSIs in endoscopy. Although many errors are minor without immediate consequence, further work should identify whether prevention of such recurrent errors affects the incidence of severe errors, thus improving safety and quality. PMID:28191498

  12. 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.

  13. 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…

  14. 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.

  15. Peer Observation: A Pilot Study.

    ERIC Educational Resources Information Center

    Einwaechter, Nelson Frederick, Jr.

    This thesis describes a peer observation program implemented among American and Japanese teachers in the English Department of Hiroshima College of Foreign Languages, a two-year vocational college in Hiroshima, Japan. Each participant functioned as both an observer and observee, while pre- and post-observation meetings were held between the…

  16. Safety and efficacy of natalizumab in Belgian multiple sclerosis patients: subgroup analysis of the natalizumab observational program.

    PubMed

    van Pesch, Vincent; Bartholomé, Emmanuel; Bissay, Véronique; Bouquiaux, Olivier; Bureau, Michel; Caekebeke, Jo; Debruyne, Jan; Declercq, Inge; Decoo, Dany; Denayer, Pierre; De Smet, Eric; D'hooghe, Marie; Dubois, Bénédicte; Dupuis, Michel; Sankari, Souraya El; Geens, Karine; Guillaume, Daniel; van Landegem, William; Lysandropoulos, Andreas; de Noordhout, Alain Maertens; Medaer, Robert; Melin, Annick; Peeters, Katelijne; Ba, Rémy Phan; Retif, Cécile; Seeldrayers, Pierrette; Symons, Anoek; Urbain, Etienne; Vanderdonckt, Patrick; Van Ingelghem, Erwin; Vanopdenbosch, Ludo; Vanroose, Erwin; Van Wijmeersch, Bart; Willekens, Barbara; Willems, Christiana; Sindic, Christian

    2014-09-01

    Natalizumab (Tysabri(®)) is highly efficacious in controlling disease activity in relapsing multiple sclerosis (MS) patients. As it is one of the more recent therapies for MS, there remains a need for long-term safety and efficacy data of natalizumab in a clinical practice setting. The Tysabri observational program (TOP) is an open-label, multicenter, multinational, prospective observational study, aiming to recruit up to 6,000 patients with relapsing-remitting MS from Europe, Canada and Australia. The objectives of this study are to collect long-term safety and efficacy data on disease activity and disability progression. We report here the interim results of the 563 patients included in TOP between December 2007 and 2012 from Belgium. This patient cohort was older at baseline, had longer disease duration, higher neurological impairment, and a higher baseline annualized relapse rate, when compared to patients included in the pivotal phase III AFFIRM trial. Nevertheless, the efficacy of natalizumab was comparable. The annualized relapse rate on treatment was reduced by 90.70 % (p < 0.0001) with a cumulative probability of relapse of 26.87 % at 24 months. The cumulative probabilities of sustained disability improvement and progression at 24 months were 25.68 and 9.01 %, respectively. There were no new safety concerns over the follow-up period. Two cases of progressive multifocal leukoencephalopathy were diagnosed. Our results are consistent with other observational studies in the post-marketing setting.

  17. 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.

  18. Safety Study--Crashworthiness of Large Poststandard Schoolbuses.

    ERIC Educational Resources Information Center

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

    This study reports on the crash performance of large poststandard school buses (school buses manufactured after April 1, 1977, and weighing more than 10,000 pounds unloaded) in 43 accidents investigated by the National Transportation Safety Board. The report discusses the Safety Board's findings as to how well the standards are working to protect…

  19. 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…

  20. 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)

  1. 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

  2. Science Studies from Archived Observations

    NASA Astrophysics Data System (ADS)

    Armstrong, T. P.; Manweiler, J. W.; Patterson, J. D.

    2008-12-01

    Goals for spaceflight investigations include the discovery and characterization of physical features of the in- situ and remote environment. Abundant successes of flight investigations are easily documented. Prudent scientific practice dictates that to the maximum extent possible, observations should be well-characterized, reliably catalogued, and knowledgeably interpreted. This is especially true of data sets used in the publication of results in the reviewed literature. Typical scientific standards include making primary data numbers available to other investigators for replicated study. While NASA's contracts with investigators have required that data be submitted to agency official archives, the details, completeness (especially of ancillary and metadata) and forms differ from investigation to investigation and project to project. After several generations of improvements and refinements, modern computing and communications technology makes it possible to link multiple data sets at multiple locations through a unified data model. Virtual Observatories provide the overall organizational structures and SPASE-compliant XML defines the data granules that can be located. Proofs of the feasibility and value of this latest approach remain to be seen, but its ultimate goal of improving archival research using flight-derived data sets appears to depend on user acceptance and efficient use of the VxO resources. Criteria based on the authors experience in science derived from archival sources follow: 1. Interfaces and tools must be easy to learn, easy to use, and reliable. 2. Data numbers must be promptly downloadable in plain text. 3. Data must be available in or readily converted to physical units using calibrations and algorithms easily traceable as part of the search. Knowledge about (or heritage of) specific data items present in the science literature must be associated with the search for that item. 4. Data items must be trustworthy, having quoted uncertainties and

  3. Active learning of plans for safety and reachability goals with partial observability.

    PubMed

    Nam, Wonhong; Alur, Rajeev

    2010-04-01

    Traditional planning assumes reachability goals and/or full observability. In this paper, we propose a novel solution for safety and reachability planning with partial observability. Given a planning domain, a safety property, and a reachability goal, we automatically learn a safe permissive plan to guide the planning domain so that the safety property is not violated and that can force the planning domain to eventually reach states that satisfy the reachability goal, regardless of how the planning domain behaves. Our technique is based on the active learning of regular languages and symbolic model checking. The planning method first learns a safe plan using the L (*) algorithm, which is an efficient active learning algorithm for regular languages. We then check whether the safe plan learned is also permissive by Alternating-time Temporal Logic (ATL) model checking. If the plan is permissive, it is indeed a safe permissive plan. Otherwise, we identify and add a safe string to converge a safe permissive plan. We describe an implementation of the proposed technique and demonstrate that our tool can efficiently construct safe permissive plans for four sets of examples.

  4. Bullet Impact Safety Study of PBX-9502

    NASA Astrophysics Data System (ADS)

    Ferranti, Louis

    2013-06-01

    A new small arms capability for performing bullet impact testing into energetic materials has recently been activated at Lawrence Livermore National Laboratory located in the High Explosives Applications Facility (HEAF). The initial capability includes 0.223, 0.30, and 0.50 testing calibers with the flexibility to add other barrels in the near future. An initial test series has been performed using the 0.50 caliber barrel shooting bullets into targets using the TATB based explosive PBX-9502 and shows an expected non-violent reaction. Future experiments to evaluate the safety of new explosive formulations to bullet impact are planned. A highlight of the new capability along with discussion of the initial experiments to date will be presented including future areas of research. This work performed under the auspices of the U.S. Department of Energy by Lawrence Livermore National Laboratory under Contract DE-AC52-07NA27344.

  5. 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)

  6. Study Sheds Light on Safety of Driving with Epilepsy

    MedlinePlus

    ... Study Sheds Light on Safety of Driving With Epilepsy Those who had longer seizures during driving tests ... SUNDAY, Dec. 4, 2016 (HealthDay News) -- People with epilepsy who experienced longer seizures during a simulated driving ...

  7. Environmental protection facilities safety study: Portsmouth Gaseous Diffusion Plant

    SciTech Connect

    Not Available

    1982-05-01

    The purpose of this Safety Study is to examine the existing facilities at the Portsmouth Gaseous Diffusion Plant that are dedicated to environmental protection. Seven separate, numbered facilities and five unnumbered continuous air sampling stations are identified as the fixed facilities to protect the environment. Each is examined from the standpoint of hazardous materials, monitoring and protection systems, confinement systems, ventilation systems, criticality control systems, fire protection systems, waste disposal systems, and safety systems.

  8. 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.

  9. Observational study of terrestrial eigenvibrations

    NASA Astrophysics Data System (ADS)

    Hansen, Roger A.

    1982-03-01

    wavelength. Second, though not conclusive, there may be slight systematic shifts in period (<0.65 s) and relative amplitudes within the California regional network due to different source positions and mechanisms. Differences in Q values are not statistically significant. Third, even though differences in period obtained worldwide were as great as 1.33 s (≈0.33%), differences between Q values (as great as 20%) for the same mode were not significant. The conclusion is that the damping characteristics of singlet eigenfunctions are not observed to be significantly different. Fourth, the assumption that a multiplet nS l behaves as a single oscillation is valid from at least 0S 7 through 0S 30. Fifth, no systematic pattern emerged for the shift of eigenperiod as a function of order / or posit on the Earth.

  10. 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.

  11. Safety of artemether-lumefantrine exposure in first trimester of pregnancy: an observational cohort

    PubMed Central

    2014-01-01

    Background There is limited data available regarding safety profile of artemisinins in early pregnancy. They are, therefore, not recommended by WHO as a first-line treatment for malaria in first trimester due to associated embryo-foetal toxicity in animal studies. The study assessed birth outcome among pregnant women inadvertently exposed to artemether-lumefantrine (AL) during first trimester in comparison to those of women exposed to other anti-malarial drugs or no drug at all during the same period of pregnancy. Methods Pregnant women with gestational age <20 weeks were recruited from Maternal Health clinics or from monthly house visits (demographic surveillance), and followed prospectively until delivery. Results 2167 pregnant women were recruited and 1783 (82.3%) completed the study until delivery. 319 (17.9%) used anti-malarials in first trimester, of whom 172 (53.9%) used (AL), 78 (24.4%) quinine, 66 (20.7%) sulphadoxine-pyrimethamine (SP) and 11 (3.4%) amodiaquine. Quinine exposure in first trimester was associated with an increased risk of miscarriage/stillbirth (OR 2.5; 1.3–5.1) and premature birth (OR 2.6; 1.3–5.3) as opposed to AL with (OR 1.4; 0.8–2.5) for miscarriage/stillbirth and (OR 0.9; 0.5–1.8) for preterm birth. Congenital anomalies were identified in 4 exposure groups namely AL only (1/164[0.6%]), quinine only (1/70[1.4%]), SP (2/66[3.0%]), and non-anti-malarial exposure group (19/1464[1.3%]). Conclusion Exposure to AL in first trimester was more common than to any other anti-malarial drugs. Quinine exposure was associated with adverse pregnancy outcomes which was not the case following other anti-malarial intake. Since AL and quinine were used according to their availability rather than to disease severity, it is likely that the effect observed was related to the drug and not to the disease itself. Even with this caveat, a change of policy from quinine to AL for the treatment of uncomplicated malaria during the whole pregnancy period

  12. Assessing observational studies of medical treatments

    PubMed Central

    Hartz, Arthur; Bentler, Suzanne; Charlton, Mary; Lanska, Douglas; Butani, Yogita; Soomro, G Mustafa; Benson, Kjell

    2005-01-01

    Background Previous studies have assessed the validity of the observational study design by comparing results of studies using this design to results from randomized controlled trials. The present study examined design features of observational studies that could have influenced these comparisons. Methods To find at least 4 observational studies that evaluated the same treatment, we reviewed meta-analyses comparing observational studies and randomized controlled trials for the assessment of medical treatments. Details critical for interpretation of these studies were abstracted and analyzed qualitatively. Results Individual articles reviewed included 61 observational studies that assessed 10 treatment comparisons evaluated in two studies comparing randomized controlled trials and observational studies. The majority of studies did not report the following information: details of primary and ancillary treatments, outcome definitions, length of follow-up, inclusion/exclusion criteria, patient characteristics relevant to prognosis or treatment response, or assessment of possible confounding. When information was reported, variations in treatment specifics, outcome definition or confounding were identified as possible causes of differences between observational studies and randomized controlled trials, and of heterogeneity in observational studies. Conclusion Reporting of observational studies of medical treatments was often inadequate to compare study designs or allow other meaningful interpretation of results. All observational studies should report details of treatment, outcome assessment, patient characteristics, and confounding assessment. PMID:16137327

  13. The DELTA Network Study of Distributed Automated Post-Market Cardiovascular Device Safety Surveillance

    PubMed Central

    Kumar, Amit; Matheny, Michael E.; Ho, Kalon K.L.; Yeh, Robert W.; Piemonte, Thomas C.; Waldman, Howard; Shah, Pinak B.; Cope, Richard; Normand, Sharon-Lise; Donnelly, Sharon; Robbins, Susan; Resnic, Frederic S.

    2016-01-01

    Background Current approaches for post-market medical device safety surveillance are limited in their ability to produce timely and accurate assessments of adverse event rates. Methods and Results The DELTA (Data Extraction and Longitudinal Trend Analysis) network study was a multicenter prospective observational study designed to evaluate the safety of devices used during percutaneous coronary interventions (PCI). All adult patients undergoing PCI from January 2008 through December 2012 at five participating Massachusetts sites were included. A safety alert was triggered if the cumulative observed adverse event rates for the study device exceeded the upper 95% confidence interval of the event rates of propensity-matched control cohort. Pre-specified sensitivity analyses were developed to validate any identified safety signal. A total of 23,805 consecutive PCI procedures were evaluated. Two out of 24 safety analyses triggered safety alerts. Patients receiving Perclose vascular closure device (VCD) experienced an increased risk of minor vascular complications (relative risk [RR] 4.14; p <0.01) and any vascular complication (RR: 2.06; p = 0.01) as compared with propensity-matched patients receiving alternative VCD; a result primarily driven by relatively high event rates at one participating center. Sensitivity analyses based on alternative risk adjustment methods confirmed the a pattern of increased rate of complications at one of the five participating sites in their use of Perclose VCD. Conclusions The DELTA network study demonstrates that distributed automated prospective safety surveillance has the potential of providing near real-time assessment of safety risks of newly approved medical devices. PMID:25491915

  14. [Oral contraceptives: recent safety studies (author's transl)].

    PubMed

    Edgren, R A

    1983-09-01

    Considerable research evidence now exists to suggest that the risks of oral contraceptive (OC) use were seriously overestimated in earlier work. Because experimentation in medicine is never possible in the rigorous sense in which it is employed in basic sciences, other sources of information must be substituted. Information on the dangers of OC use has come from anecdotal reports, retrospective case control studies, prospective cohort studies, and statistical analyses of deaths, each source being associated with specific problems of interpretation. Recent findings of the Royal College of General Practitioners, the Walnut Creek Study, and the Oxford Study have suggested a lowered incidence of malignant neoplasms in OC than in IUD or diaphragm users; a reduced incidence of breast cancer although the relationship did not consistently achieve statistical significance, and a reduced incidence of ovarian and endometrial cancer. The risks of cervical cancer among OC users appeared slightly higher but disappeared when sexual behavior was controlled. Despite much concern with the possibility of postpill amenorrhea and perhaps sterility among women discontinuing OC use, it now appears that after 2 years there is no difference in the fertility of women who have discontinued use of OCs, IUDs, or diaphragms. Use of OCs as a contraceptive before pregnancy does not appear to be associated with fetal malformations, spontaneous abortion, or perinatal mortality, and the inadvertent use of OCs in early pregnancy is apparently associated with only a very slight risk of anomalies. Recent studies of cardiovascular disease risks indicate that the relative risks of cardiovascular disease among OC users have been greatly exaggerated, especially when smoking is taken into account. Various studies of mortality data have failed to establish a link between OC use and excess mortality from cardiovascular disease.

  15. [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.

  16. 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

  17. Safety study of Ciprofloxacin in newborn mice.

    PubMed

    Bourgeois, Thomas; Delezoide, Anne-Lise; Zhao, Wei; Guimiot, Fabien; Adle-Biassette, Homa; Durand, Estelle; Ringot, Maud; Gallego, Jorge; Storme, Thomas; Le Guellec, Chantal; Kassaï, Behrouz; Turner, Mark A; Jacqz-Aigrain, Evelyne; Matrot, Boris

    2016-02-01

    Ciprofloxacin, a broad-spectrum antimicrobial agent belonging to the fluoroquinolone family, is prescribed off-label in infants less than one year of age. Ciprofloxacin is included in the European Medicines Agency priority list of off-patent medicinal products requiring evaluation in neonates. This evaluation is undergoing within the TINN (Treat Infections in Neonates) FP7 EU project. As part of the TINN project, the present preclinical study was designed to assess the potential adverse effects of Ciprofloxacin on neurodevelopment, liver and joints in mice. Newborn mice received subcutaneous Ciprofloxacin at 10, 30 and 100 mg/kg/day from 2 to 12 postnatal days. Peak plasma levels of Ciprofloxacin were in the range of levels measured in human neonates. We examined vital functions in vivo, including cardiorespiratory parameters and temperature, psychomotor development, exploratory behavior, arthro-, nephro- and hepato-toxic effects. We found no effect of Ciprofloxacin at 10 and 30 mg/kg/day. In contrast, administration at 100 mg/kg/day delayed weight gain, impaired cardiorespiratory and psychomotor development, caused inflammatory infiltrates in the connective tissues surrounding the knee joint, and moderately increased extramedullary hematopoiesis. The present study pleads for careful watching of cardiorespiratory and motor development in neonates treated with Ciprofloxacin, in addition to the standard surveillance of arthrotoxicity.

  18. Earth Observing System: Global Observations to Study the Earth's Environment

    NASA Technical Reports Server (NTRS)

    King, Michael D.

    2003-01-01

    The Earth Observing System (EOS) is a space-based observing system comprised of a series of satellite sensors by which scientists can monitor the Earth, a Data and Information System (EOSDIS) enabling researchers worldwide to access the satellite data, and an interdisciplinary science research program to interpret the satellite data. During the last couple of years, four EOS science missions were launched, representing observations of (i) total solar irradiance, (ii) Earth radiation budget, (iii) land cover & land use change, (iv) ocean processes (vector wind, sea surface temperature, and ocean color), (v) atmospheric processes (aerosol and cloud properties, water vapor, and temperature and moisture profiles), and (vi) tropospheric chemistry. In succeeding years many more satellites will be launched that will contribute immeasurably to our understanding of the Earth's environment. In this presentation I will describe how scientists are using NASA's Earth science data to examine land use and natural hazards, environmental air quality, including: dust storms over the worlds deserts, cloud and radiation properties, sea surface temperature, and winds over the ocean, with a special emphasis on satellite observations available for studying the southern African environment.

  19. System Safety Hazards Assessment in Conceptual Program Trade Studies

    NASA Technical Reports Server (NTRS)

    Eben, Dennis M.; Saemisch, Michael K.

    2003-01-01

    Providing a program in the concept development phase with a method of determining system safety benefits of potential concepts has always been a challenge. Lockheed Martin Space and Strategic Missiles has developed a methodology for developing a relative system safety ranking using the potential hazards of each concept. The resulting output supports program decisions with system safety as an evaluation criterion with supporting data for evaluation. This approach begins with a generic hazards list that has been tailored for the program being studied and augmented with an initial hazard analysis. Each proposed concept is assessed against the list of program hazards and ranked in three derived areas. The hazards can be weighted to show those that are of more concern to the program. Sensitivities can be also be determined to test the robustness of the conclusions

  20. 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

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

    PubMed

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

    2015-09-01

    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.

  2. 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.

  3. 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.

  4. Safety and efficacy of adalimumab treatment in Japanese patients with psoriasis: Results of SALSA study.

    PubMed

    Asahina, Akihiko; Torii, Hideshi; Ohtsuki, Mamitaro; Tokimoto, Toshimitsu; Hase, Hidenori; Tsuchiya, Tsuyoshi; Shinmura, Yasuhiko; Reyes Servin, Ofelia; Nakagawa, Hidemi

    2016-11-01

    The safety and efficacy of adalimumab were evaluated over 24 weeks in Japanese patients with psoriasis in routine clinical practice. In this multicenter, observational, open-label, postmarketing study, primary efficacy measures included the Psoriasis Area and Severity Index (PASI) and the Dermatology Life Quality Index (DLQI) in all patients with psoriasis. In patients with psoriatic arthritis (PsA), the 28-joint Disease Activity Score (DAS28) and the visual analog scale (VAS) pain were also evaluated. Safety was assessed based on the frequency of adverse drug reactions (ADR). Among patients with psoriasis evaluated for efficacy (n = 604), significant improvements from baseline were observed in mean PASI and DLQI scores at weeks 16 and 24 (all P < 0.0001). Furthermore, in psoriasis patients without PsA, the PASI 75/90 response rates were 55.9%/28.4% at week 16 (n = 306) and 65.6%/43.3% at week 24 (n = 270), respectively. In patients with PsA evaluable for effectiveness, significant improvements from baseline were observed in PASI, DAS28 erythrocyte sedimentation rate, DAS28 C-reactive protein and VAS pain at weeks 16 and 24 (all P < 0.0001). ADR and serious ADR were reported by 26.1% and 3.3%, respectively, of 731 safety evaluable patients with psoriasis; no unexpected safety findings were noted. The safety profile and effectiveness of adalimumab for the treatment of psoriasis in a routine clinical setting were as expected in Japanese patients.

  5. 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

  6. A Prospective Study for Introducing Insulin Pens and Safety Needles in a Hospital Setting. The SANITHY Study.

    PubMed Central

    Bossi, Antonio C.; Veronesi, Giovanni; Poerio, Carmine S.; Braus, Alessandra; Madaschi, Sara; Destro, Maurizio; Ferraro, Bruno; Gilberti, Lavinia; Sganzerla, Paolo; Davis, Estella M.

    2016-01-01

    Abstract: Background To assess costs and safety of insulin pen devices and safety needles as compared to vial/syringes in hospitalized patients requiring insulin therapy in a General Hospital in Northern Italy. Materials and Methods In a prospective 9-month study, consecutive patients admitted to three Hospital Units received insulin therapy through either a traditional disposable syringe method, or pen/safety needles with dual-ended protection, or disposable safety syringes. We compared the median direct (insulin and devices) and indirect (insulin supply at discharge, insulin wastage) costs of a 10-day in-hospital insulin treatment in the 3 study groups, additionally accounting for the costs related to the observed needlestick injury rate. Patients’ safety during in-hospital stay (hypo- and hyperglycemia episodes) and satisfaction were also assessed. Results N=360 patients (55% men, mean age 75.6 years, 57% with DM since ≥10 years) were recruited in the study. Insulin pens had higher median direct cost than both traditional syringes (43 vs. 18 €/patient, p<.0001) and safety syringes (21.5 €/patient, p<.0001). However, when also indirect and injuries costs were taken into account, the estimated savings for using pens over traditional syringes were as high as 32 €/patient (45.8 vs. 77.6 €/patient, p-value <.0001). No differences in patients’ safety were observed. 74% and 12% of patients using pens and syringes would like to continue the method at home, respectively (p<0.0001). Discussion A selective use of individual pre-filled pens/safety needles for patients who are likely to continue insulin therapy at home may strongly reduce hospital diabetes treatment related costs. PMID:26245310

  7. An Evaluation of a Distributed Medical Device Safety Surveillance System: The DELTA Network Study

    PubMed Central

    Vidi, Venkatesan D.; Matheny, Michael E.; Donnelly, Sharon; Resnic, Frederic S.

    2011-01-01

    Background Post-market medical product safety surveillance is a complex task requiring standardized data collection, prompt adverse event reporting mechanisms and appropriate methodologies to identify low frequency safety threats and risk communication. Purpose To review the design of the DELTA (Data Extraction and Longitudinal Trend Analysis) network study of the medical device safety surveillance. Methods This is a multicenter prospective observational study designed to evaluate the safety of new cardiovascular devices used during percutaneous coronary intervention (PCI) performed through continuous analysis of the routinely collected American College of Cardiology- National Cardiovascular Data Registry (ACC-NCDR) data elements. The primary endpoint of the study is detection of adverse event rates specific to several classes of new medical devices, including drug eluting coronary stents, embolic protection devices, and vascular closure devices in patients undergoing PCI. Secondary endpoints include the time-savings between the DELTA network detection of a true device safety alert and the time taken to detect the same outcome using conventional retrospective data analysis, overall sensitivity, specificity, positive predictive value and negative predictive value of the DELTA network surveillance system. Results The details of the study are described including system design, eligibility criteria, methods and components of data collection, data security and statistical methods. In addition, the methods of adjudication and verification following an adverse event alert, overall study outcomes, end points, limitations and potential advantages are discussed. Conclusion This report describes the first multicenter prospective study of a computerized safety surveillance system to monitor and evaluate the safety of new cardiovascular devices. PMID:21356331

  8. 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

    ... (SOHSS), National Institute for Occupational Safety and Health (NIOSH) In accordance with section 10(a)(2... and funding cycles pertaining to research issues in occupational safety and health, and allied areas... focused research projects, which will lead to improvements in the delivery of occupational safety...

  9. Safety assessment for hair-spray resins: risk assessment based on rodent inhalation studies.

    PubMed

    Carthew, Philip; Griffiths, Heather; Keech, Stephen; Hartop, Peter

    2002-04-01

    The methods involved in the safety assessment of resins used in hair-spray products have received little peer review, or debate in the published literature, despite their widespread use, in both hairdressing salons and the home. The safety assessment for these resins currently involves determining the type of lung pathology that can be caused in animal inhalation exposure studies, and establishing the no-observable-effect level (NOEL) for these pathologies. The likely human consumer exposure is determined by techniques that model the simulated exposure under "in use" conditions. From these values it is then possible to derive the likely safety factors for human exposure. An important part of this process would be to recognize the intrinsic differences between rodents and humans in terms of the respiratory doses that each species experiences during inhalation exposures, for the purpose of the safety assessment. Interspecies scaling factors become necessary when comparing the exposure doses experienced by rats, compared to humans, because of basic differences between species in lung clearance rates and the alveolar area in the lungs. The rodent inhalation data and modeled human exposure to Resin 6965, a resin polymer that is based on vinyl acetate, has been used to calculate the safety factor for human consumer exposure to this resin, under a range of "in use" exposure conditions. The use of this safety assessment process clearly demonstrates that Resin 6965 is acceptable for human consumer exposure under the conditions considered in this risk assessment.

  10. Patient safety in genomic medicine: an exploratory study

    PubMed Central

    Korngiebel, Diane M.; Fullerton, Stephanie M.; Burke, Wylie

    2016-01-01

    Purpose Concerns about patient safety and the potential for medical error are largely unexplored for genetic testing despite the expansion of test use. In this preliminary qualitative study we sought the views of genetics professionals about error and patient safety concerns in genomic medicine and factors that might mitigate them. Methods Twelve semi-structured interviews with experienced genetics professionals were conducted. Transcripts were analyzed using selective coding for issues related to error definition, mitigation, and communication. Additional thematic analysis captured themes across content categories. Results Key informants suggested that the potential for adverse events exists in all phases of genetic testing, from ordering to analysis, interpretation, and follow-up. A perceived contributor was lack of physician knowledge about genetics, resulting in errors in test ordering and interpretation. The limitations and uncertainty inherent to rapidly evolving technology were also seen as contributing factors. Strategies to prevent errors included physician education, availability of genetic experts for consultation, and enhanced communication such as improved test reports and electronic decision support. Conclusion Genetic testing poses concerns for patient safety, due to errors and the limitations of current tests. As genomic tests are integrated into medical care, anticipating and addressing the patient safety concerns these key informants identified will be crucial. PMID:27011058

  11. 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.

  12. 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.

  13. [Observational Team work Assessment for Surgery as Quality and Safety improvement tool].

    PubMed

    Amato, S; Basilico, O; Bevilacqua, L; Burato, E; Levati, A; Molinelli, V; Picchetti, C; Suardi, R; Trucco, P; Lucchina, C

    2010-01-01

    As in high reliability systems , also in surgery the causes of adverse events are primarily correlated to deficiencies in Non Technical Skills (individual and social skills), that contribute with Technical Skills to a safe surgical procedure. Non Technical Skills are cognitive behavioural and interpersonal abilities, that are not specific to the expertise of one profession, but very important to guarantee the patient safety and to reduce risk of errors and adverse events. The Observational Teamwork Assessment for Surgery (OTAS) is an useful tool to assess teamwork of the whole surgical team (surgeons, anaesthetists, nurses) in real time and through the surgical procedure (pre-intra-postoperative phases). OTAS consists of the two following parts: a) teamwork-related task checklist to fill by a surgeon, b) teamwork-related behaviours rated by a psychologist/human factors expert. Back translation in Italian language of the eight task checklists and of the rating scales of the five behavioural areas was performed by two Italian surgeons with certified English language knowledge. The OTAS model in Italian language was applied in four surgical procedures : the test-retest reliability was found to be acceptable with K- Pearson index. The internal consistency of behavioural scales appeared sound using Cronbach ?. OTAS is an useful tool to assess the risk factors correlated to patient and team and to detect the vulnerability areas where changes to reduce errors and improve surgical outcomes might be introduced.

  14. 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.

  15. 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.

  16. 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...

  17. 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…

  18. 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".

  19. Metals in wheat flour; comparative study and safety control.

    PubMed

    Tejera, Raquel L; Luis, G; González-Weller, Dailos; Caballero, José M; Gutiérrez, Angel J; Rubio, Carmen; Hardisson, Arturo

    2013-01-01

    Cereal industry and its derived products have a big economic and social importance worldwide. Therefore, as wheat flour is a commodity for all bread and bakery industry, it is safety is of high nutrition and toxicological interest. In this investigation we intend to study and determine the content of twelve metals in 50 samples of wheat flour coming from a wheat flour industry. Macro elements sodium, potassium magnesium and calcium, micro elements manganese, iron, copper, zinc, chrome and nickel as well as toxic trace elements cadmium and lead have been analysed. The estimated diary intake of each metal and their contribution in percentage terms to the RDI (macro and micro elements) and to the PTWI (toxic elements) has been determined. Contribution of Cd and Pb to the PTWI was very low, a fact that shows safety in this wheat flour concerning toxic metals.

  20. 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.

  1. Behavioral risk factors associated with listeriosis in the home: a review of consumer food safety studies.

    PubMed

    Evans, Ellen W; Redmond, Elizabeth C

    2014-03-01

    Listeria monocytogenes causes human listeriosis, which is associated with the highest hospitalization and mortality rates of all foodborne illnesses. In recent years, the incidence of listeriosis has doubled in Europe, almost exclusively among older adults (≥ 60 years of age). Food safety factors associated with increased risk of listeriosis include lack of adherence to "use by" dates and ineffective refrigerated storage of foods. Consequently, older adult consumers' implementation of safe food practices should be evaluated. This article is a review of consumer food safety cognitive and behavioral data relating to risk factors associated with listeriosis in the home as reported in 165 consumer food safety studies. Overall, only 41% of studies included assessment of consumer cognitive or behavioral data associated with listeriosis; of these studies 59% included data on safe refrigeration, 54% included data on storage time for opened ready-to-eat foods, and 49% included data on adherence to use-by dates. In most (83%) of the studies, survey-based data collection methods (questionnaires/interviews) were used; thus, the majority of findings were based on self-report (74%) and knowledge (44%). Observation (31%) and focus groups (12%) were less commonly used, resulting in a lack of actual behaviors and attitudinal data relating to listeriosis risk factors. Only 7% of studies included food safety data for older adults. Although older adults may fail to implement recommended practices, this review reveals a need for in-depth research to determine food safety attitudes and actual behaviors of older adults in conjunction with knowledge and selfreport of practices linked to increased risks of listeriosis. Such data combined with review findings would inform targeted food safety education to reduce risks associated with listeriosis in the home.

  2. 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.

  3. A study of the costs and benefits of a Formal Safety Program

    SciTech Connect

    Crites, T.R.

    1993-03-01

    This study reports on a review of the safety programs and performance at 13 Department of Energy contractor facilities, involving over one-half million man-years of experience. Safety performance was compared with the size of staff and safety department funding over an 11-year period (1980-1990). Indicators of safety performance were taken as lost workdays, recordable injuries, accidental dollar losses, worker radiation dose, and worker`s compensation expenditures. Safety performance was found to be independent of, or even inversely related to, safety investment. Those organizations with the largest safety programs also experienced the greatest accidental losses.

  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

    ... (SOHSS), National Institute for Occupational Safety and Health (NIOSH) In accordance with section 10(a)(2... standard grants review and funding cycles pertaining to research issues in occupational safety and health... support more focused research projects, which will lead to improvements in the delivery of...

  5. A feature study of innovative high-speed lancing device and safety lancet.

    PubMed

    Chang, Ho; Yeh, Yao-Jen; Lee, Rahnfong; Shyu, Jenq-Huey

    2016-12-01

    The study developed two models of an innovative high-speed lancing device and safety lancet, where the specially designed structure causes high-speed motion of the lancet, resulting in only one puncture of the skin. The two experimental models and other lancing devices sold on market were compared in order to: (1) measure the forces of lancets piercing animal skin by a load cell; (2) observe the wound areas caused by lancing devices under a microscope. The experimental results showed that, after using this innovative high-speed lancing device, the maximum force of a lancet piercing skin is only 1/3 of the force of conventional lancing devices, and the duration of the former under the skin is 1/6 of the latter. In addition, the wound area caused by the innovative lancing device is 20 % smaller than those of the conventional lancing devices. Usage of this innovative high-speed safety lancet shows that its maximum skin-piercing force is only 2/3 of conventional safety lancets, its duration under the skin is 1/4 of conventional safety lancets, and the wound area is 12 % smaller. In conclusion, both the innovative high-speed lancing device and safety lancet are proved effective in alleviating pain for diabetics and shortening the recovering time for wounds, thus, providing a more comfortable process for the self-monitoring of blood glucose.

  6. 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

  7. 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.

  8. Review of quality assessment tools for the evaluation of pharmacoepidemiological safety studies

    PubMed Central

    Neyarapally, George A; Hammad, Tarek A; Pinheiro, Simone P; Iyasu, Solomon

    2012-01-01

    Objectives Pharmacoepidemiological studies are an important hypothesis-testing tool in the evaluation of postmarketing drug safety. Despite the potential to produce robust value-added data, interpretation of findings can be hindered due to well-recognised methodological limitations of these studies. Therefore, assessment of their quality is essential to evaluating their credibility. The objective of this review was to evaluate the suitability and relevance of available tools for the assessment of pharmacoepidemiological safety studies. Design We created an a priori assessment framework consisting of reporting elements (REs) and quality assessment attributes (QAAs). A comprehensive literature search identified distinct assessment tools and the prespecified elements and attributes were evaluated. Primary and secondary outcome measures The primary outcome measure was the percentage representation of each domain, RE and QAA for the quality assessment tools. Results A total of 61 tools were reviewed. Most tools were not designed to evaluate pharmacoepidemiological safety studies. More than 50% of the reviewed tools considered REs under the research aims, analytical approach, outcome definition and ascertainment, study population and exposure definition and ascertainment domains. REs under the discussion and interpretation, results and study team domains were considered in less than 40% of the tools. Except for the data source domain, quality attributes were considered in less than 50% of the tools. Conclusions Many tools failed to include critical assessment elements relevant to observational pharmacoepidemiological safety studies and did not distinguish between REs and QAAs. Further, there is a lack of considerations on the relative weights of different domains and elements. The development of a quality assessment tool would facilitate consistent, objective and evidence-based assessments of pharmacoepidemiological safety studies. PMID:23015600

  9. Motorcyclists' reactions to safety helmet law: a qualitative study

    PubMed Central

    Zamani-Alavijeh, Fereshteh; Niknami, Shamsaddin; Mohammadi, Eesa; Montazeri, Ali; Ghofranipour, Fazlollah; Ahmadi, Fazlollah; Bazargan, Shahrzad Hejazi

    2009-01-01

    Background Extensive body of the literature reveals that proper use of helmets is an effective way to reduce the severity of injuries and fatalities among motorcyclists. However, many motorcyclists do not use safety helmet properly. This study aimed to empirically explore reactions of motorcyclists to the safety helmet laws, in Iran. Methods Qualitative data were collected via four focus groups and 11 in-depth interviews. Participants were 28 male motorcyclists who never used a safety helmet during rides, and 4 male police officers. All transcripts, codes and categories were read for several times to exhaust identifiable major themes. During this process data were reduced from text to codes and themes. Results Five major themes emerged from the data analyses, including themes related to the following: (1) circumventing or dodging police officers; (2) simulating a helmet wearing behavior; (3) accepting the probability of receiving a ticket; (4) taking advantage of the police neglect and carelessness; and (5) using a cheap or convenient helmet. Conclusion Our findings suggest certain levels of reckless driving among the participating motorcyclists in this study. They also point to a system of law enforcement that operates haphazardly and fails to consistently penalize those who deviate from it. Further studies are needed to investigate how "risks" are perceived and relate to "reactions", and how a 'culture of masculinity' may encourage risk tolerance and a disposition toward lawlessness and carelessness among male motorcyclists. Also, there is a need for the development and implementation of multidimensional interventions that would offer socio-culturally sensitive educational and motivational messages to the motorcyclists and the in-service traffic-enforcement officers in Iran. PMID:19843325

  10. 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

  11. 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.

  12. 40 CFR 720.90 - Data from health and safety studies.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 31 2014-07-01 2014-07-01 false Data from health and safety studies... Data from health and safety studies. (a) Information other than specific chemical identity. Except as... information included in a health and safety study, unless the information would disclose confidential...

  13. Earth Observing System: Global Observations to Study the Earth's Environment

    NASA Technical Reports Server (NTRS)

    King, Michael D.

    2001-01-01

    The Earth Observing System (EOS) is a space-based observing system comprised of a series of satellite sensors by which scientists can monitor the Earth, a Data and Information System (EOSDIS) enabling researchers worldwide to access the satellite data, and an interdisciplinary science research program to interpret the satellite data. During the last couple of years, four EOS science missions were launched, representing observations of (1) total solar irradiance, (2) Earth radiation budget, (3) land cover & land use change, (4) ocean processes (vector wind, sea surface temperature, and ocean color), (5) atmospheric processes (aerosol and cloud properties, water vapor, and temperature and moisture profiles), and (6) tropospheric chemistry. In succeeding years many more satellites will be launched that will contribute immeasurably to our understanding of the Earth's environment. In this presentation I will describe how scientists are using NASA's Earth science data to examine land use and natural hazards, environmental air quality, including dust storms over the world's deserts, cloud and radiation properties, sea surface temperature, and winds over the ocean.

  14. Child Study and Observation: Child Development 101.

    ERIC Educational Resources Information Center

    Jones, Joanna

    This syllabus outlines the structure, objectives, and lesson plans for Child Development 101, a twelve-week course on child study and observation offered at Chaffey Community College. A statement of the educational philosophy upon which the course was developed precedes a list of course objectives, competencies, and the grading system. The bulk of…

  15. Workplace Education Initiative: Case Studies and Observations.

    ERIC Educational Resources Information Center

    Astrein, Bruce; And Others

    Seven workplace education projects funded in the first year of the Massachusetts Workplace Education Initiative are reported. This report includes both general observations and specific information in case studies of the projects. Overall information is provided on students served, the importance of partnerships, the emphasis on…

  16. Patient safety education among chinese medical undergraduates: An empirical study.

    PubMed

    Li, Gang; Tao, Hong-Bing; Liao, Jia-Zhi; Tang, Jin-Hui; Peng, Fang; Shu, Qin; Li, Wen-Gang; Tu, Shun-Gui; Chen, Zhuo

    2016-10-01

    Patient safety education is conducive to medical students' cognition on patient safety and to improvement of medical quality and safety. Developing patient safety education for medical students is more and more widely recognized by World Health Organization and countries all over the world. However, in China, patient safety courses aiming at medical students are relatively few, and there are few reports about the effect of patient safety courses. This paper explored the influence of patient safety curriculum on medical students' attitude to and knowledge of patient safety. The patient safety curriculum was carried out for 2011-grade undergraduates of Tongji Medical College, Huazhong University of Science and Technology. The students participated in the class according to free choice. After the curriculum, the information of gender, major, attended course, attitude toward patient safety, and knowledge of laws and regulations of the 2011-grade undergraduates were collected. After rejecting invalid questionnaires, the number of undergraduates that participated in the survey was 112 (61 students did not take part in the curriculum; 51 took part in). Chi-square test was applied to analyze patient safety education's influence on medical students' attitude to patient safety and their knowledge mastery situation. The influence of patient safety education on the attitude of medical students to patient safety was not significant, but that on their knowledge of patient safety was remarkable. No matter male or female, as compared with medical students who had not accepted patient safety education, they both had a better acquisition of knowledge after having this education (for male students: 95% CI, 4.556-106.238, P<0.001; for female students: 95% CI, 3.183-33.238, P<0.001). Students majoring in Western Medicine had a relatively better mastery of knowledge of patient safety after receiving patient safety education (95% CI, 6.267-76.271, P<0.001). Short-term patient safety

  17. 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

  18. 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.

  19. 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

  20. 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.

  1. An observational study of quiescent novae

    NASA Astrophysics Data System (ADS)

    Dhillon, V. S.

    1990-01-01

    Quiescent novae are close binary stars which are characterised by the presence of Balmer and HeII emission lines in their optical spectra. In high-inclination systems, standard theory predicts that one should observe double-peaked emission line profiles which are eclipsed once every orbital period. However, the emission lines of eclipsing quiescent novae are single-peaked and uneclipsed, in obvious conflict with currently held beliefs on the nature of these systems. It is the purpose of this thesis to solve this long-standing problem and so arrive at a theoretical model for quiescent novae which is consistent with the observational evidence. The first part of the thesis sets the scene to the problem by presenting an overview of the conflicting observational and theoretical results. The second part then reports on a number of new observations obtained during the course of this work which have shed new light on the problem. The results of these new observations are presented in Part III of the thesis, where one chapter is devoted to each of the three objects studied (V1315 Aquilae, SW Sextantis and DW Ursae Majoris). The final part of the thesis is a discussion and comparison of the various results presented in Part III. Using these results, a series of observational constraints are defined which are then applied to a number of existing theoretical models. In the case of V1315 Aql and SW Sex, the very stringent set of constraints results in there being no single model capable of explaining the observed phenomena. DW UMa is even more enigmatic, appearing in a previously unseen low-state during which the mass transfer rate appears to have reduced dramatically and the optical spectra are dominated by Balmer emission from the inner face of the secondary star. The implications of these new observations for the wider field of cataclysmic variables are discussed, followed by a short summary of future work necessary to validate the origin, evolution and behaviour of the

  2. 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.

  3. 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.

  4. 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.

  5. 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…

  6. Ferrocyanide Safety Project: Subtask 3. 4, Aging Studies

    SciTech Connect

    Lilga, M.A.; Lumetta, M.R.; Riemath, W.F.; Romine, R.A.; Schiefelbein, G.F.

    1992-11-01

    The Hanford Ferrocyanide Task Team is addressing issues involving ferrocyanide precipitates in single-shell waste storage tanks (SSTs), in particular the storage of waste in a safe manner. This Task Team, composed of researchers from Westinghouse Hanford Company (WHC), Pacific Northwest Laboratory (PNL), and outside consultants, was formed in response to the need for an updated analysis of safety questions about the Hanford ferrocyanide tanks. This annual report gives the results of the work conducted by PNL in FY 1992 on Subtask 3.4, Aging Studies, which is part of Task 3, Chemical Nature of Feffocyanide in Wastes. Subtask 3.4 deals with the aging behavior and solubilization of ferrocyanide tank waste sludges in a basic aqueous environment. Investigated were the effects of pH variation, ionic strength, salts present in SSTS, and gamma radiation on solubilization of vendor-prepared Na[sub 2]NiFe(CN)[sub 6].

  7. Is Duhuo Jisheng Tang containing Xixin safe? A four-week safety study

    PubMed Central

    2010-01-01

    Background Though the nephrotoxicity and carcinogenicity of aristolochic acid (AA) are known, its safety in clinical usage is not clear. This study aims to evaluate the safety of Duhuo Jisheng Tang (DJT) in a four-week study to treat osteoarthritis (OA) of the knee. Methods A qualitative and quantitative investigations on DJT were conducted. A list of adverse events (AEs), complete blood counts, and liver and kidney function tests were measured for participants with knee OA at their scheduled hospital visits. Each detected AEs was independently assessed for severity and causality by site investigators (Chinese medical doctors) and study nurses. Results A total of 71 eligible subjects were included in the clinical study where 287 AEs were reported. DJT did not contain detectable aristolochic acid (AA) under thin-layer chromatography (TLC) analysis and gas chromatography coupled with mass spectrometry (GC-MS). There were no significant changes in liver or kidney functions. Conclusion In four-week use of DJT, no renal tubular damage, no severe incidences of AEs and adverse drug reactions (ADRs) were observed. The present study obtained safety data from active surveillance of DJT. PMID:20181195

  8. 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.

  9. Safety studies on products from whole coffee fruit.

    PubMed

    Heimbach, J T; Marone, P A; Hunter, J M; Nemzer, B V; Stanley, S M; Kennepohl, E

    2010-01-01

    The fruit of the coffee plant, Coffea arabica, has high phenolic antioxidant and phytonutrient content and could be a beneficial food ingredient. However, the fruit has historically been discarded for the favored harvesting of the coffee bean alone. CoffeeBerry products are derived from the whole fruit and include a ground whole powder, a water extract, and a more recently developed water-ethanol extract. The safety of CoffeeBerry products was evaluated in three genotoxicity studies, three short-term oral toxicity studies, and a 90-day dietary toxicity study. Bacterial mutagenicity studies and a micronucleus test using murine peripheral cells demonstrated that none of the three products showed mutagenic or genotoxic potential. In the short-term studies, despite palatability issues, female rats showed a tolerance for whole powder and ethanol extract at doses up to 8800 mg/kg bw/day. Male rats also exhibited palatability issues and tolerated lower doses of approximately 4000 mg/kg bw/day ethanol extract via gavage and approximately 2100 mg/kg bw/day whole powder or water extract in the diet. When fed in the diet to Sprague-Dawley rats for 90 days, ethanol extract showed no adverse effects at dietary concentrations of up to 5% (approximately 3446 and 4087 mg/kg bw/day for male and female rats, respectively).

  10. 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…

  11. [Results of the multicenter prospective study of cerebrolysin safety and efficacy in acute stroke].

    PubMed

    Skwortsova, V I; Stakhovskaia, L V; Shamalov, N A; Kerbikov, O B

    2006-01-01

    The multicenter prospective study of cerebrolysin safety and efficacy included 277 patients with ischemic stroke aged 55-85 years, who received therapy within 12 h from the disease development. Cerebrolysin was used in dosage 10 ml daily along with concomitant standard basic treatment during 10 days after stroke onset in 138 patients. A control group comprised 139 patients who received basic treatment only. A quantitative analysis of the dynamics of neurological deficit revealed the accelerated improvement by NIHSS score, modified Rankin score and Barthel index in the cerebrolysin group on days 10 and 28 (p<0,05). The significant improvement of NIHSS score was observed on day 28 (p<0,05) in patients treated with cerebrolysin within the first 3h after stroke onset comparing to those treated within 6-12h. The trial demonstrated cerebrolysin safety and good tolerability in treatment of ischemic stroke in the carotid artery territory as well as its favorable clinical effect.

  12. A CONTROLLED SAFETY STUDY OF DIINDOLYLMETHANE IN THE IMMATURE RAT MODEL

    PubMed Central

    Elackattu, Alphi P.; Feng, Lining; Wang, Zhi

    2010-01-01

    OBJECTIVE Diindolylmethane, a natural product from cruciferous vegetables, has been shown to be a dietary component that has inhibitory effects on some tumors (e.g., laryngeal papilloma). However, current evidence to support its safety is based on adult humans or mature animals. There is little to show its safety in children. This study is designed to asses safety in the young rat model STUDY DESIGN Prospective Controlled Animal Study. METHODS 40 rats were separated into 4 treatment groups of 10 rats each, based on the amount of study drug they received in their daily food: 1. Immature rats fed low dose DIM, which is our proposed treatment dose (2.0mg/kg/day). 2. Immature rats fed high dose DIM (20.0mg/kg/day). 3. Immature rats fed no DIM (control). 4. Adult rats fed high dose DIM (20.0mg/kg/day). At the conclusion of the study we collected blood to compare serum chemistries and vitamin D levels, and harvest organs to observe for any gross or histological changes between the groups. Statistical methods involved one-way ANOVA and pairwise comparisons with Tukey’s multiple comparison adjustment. RESULTS Although our numbers do not allow for statistical significance, there was no appreciable difference in rat weights between the immature groups, nor was there appreciable difference between serum chemistries, or gross or histological examination of liver, kidney, or bone. CONCLUSIONS Diindolylmethane seems to have no adverse affects on the rat even when given in doses 10x what we propose to be therapeutic. This adds evidence to the safety of this drug in the pediatric population as a treatment option for recurrent respiratory papilloma. PMID:19544380

  13. Safety studies regarding a standardized extract of fermented wheat germ.

    PubMed

    Heimbach, James T; Sebestyen, Gyula; Semjen, Gabor; Kennepohl, Elke

    2007-01-01

    "Avemar pulvis" is a powder consisting of an aqueous extract of fermented wheat germ, with the drying aids maltodextrin and silicon dioxide, standardized to contain approximately 200 microg/g of the natural constituent 2,6-dimethoxy-p-benzoquinone. The results of toxicological and clinical studies of this product demonstrate its safety for its intended use as a dietary supplement ingredient in the United States. Avemar pulvis has been used in Hungary since 1998 and is approved in that country, as well as in the Czech Republic, Bulgaria, and Romania, as a "medical nutriment for cancer patients." Acute and subacute toxicity studies using rodents orally administered Avemar pulvis showed that dose levels (2000 to 3000 mg/kg body weight [bw]/day) exceeding the normal recommended oral dosage (8.5 g/day or 121 mg/kg bw/day for a 70-kg individual) by up to approximately 25-fold caused no adverse effects. The test substance showed no evidence of mutagenicity or genotoxicity in vitro or in vivo. Clinical studies using Avemar pulvis as a supplement to drug therapy in cancer patients at doses of 8.5 g/day not only showed no evidence of toxicity, but also showed a reduction in the side effects of chemotherapy. Overall, it was concluded that Avemar pulvis would not be expected to cause adverse effects under the conditions of its intended use as an ingredient in dietary supplements.

  14. 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

  15. A study of the safety of tenoxicam in general practice.

    PubMed

    Caughey, D; Waterworth, R F

    1989-11-08

    An open, noncomparative study was undertaken to examine the safety of tenoxicam, a new nonsteroidal antiinflammatory drug (NSAID) in general practice. One thousand two hundred and sixty-seven patients with rheumatic conditions were recruited by 392 general practitioners throughout New Zealand. Forty-three point six percent of patients recruited were over 65 years of age, 62.5% had some form of concomitant disease and 76.3% of patients were already receiving NSAIDs. Three hundred and four (23.9%) patients experienced adverse drug reactions, the commonest being gastrointestinal (11.4%), central and peripheral nervous system disorders (2.8%) and skin reactions (2.5%). The profile of adverse drug reactions in those more than 65 was similar to those in patients under 65 years. Of the reactions reported, 14.7% were considered severe. Three peptic ulcers were reported. There were no unexpected adverse drug reactions. Eight hundred and forty-nine patients completed 6 months treatment. Subjective assessments of overall efficacy, pain at night, pain on movement and stiffness made before treatment and at 1, 3 and 6 months posttreatment showed that tenoxicam significantly improved all parameters. The clinical response was maintained throughout the 6 month study period and was not different in patients less than or greater than 65 years.

  16. 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.

  17. 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.

  18. Altered threat and safety neural processing linked to persecutory delusions in schizophrenia: a two-task fMRI study

    PubMed Central

    Perez, David L.; Pan, Hong; Weisholtz, Daniel S.; Root, James C.; Tuescher, Oliver; Fischer, David B.; Butler, Tracy; Vago, David R.; Isenberg, Nancy; Epstein, Jane; Landa, Yulia; Smith, Thomas E.; Savitz, Adam J.; Silbersweig, David A.; Stern, Emily

    2016-01-01

    Persecutory delusions are a clinically important symptom in schizophrenia associated with social avoidance and increased violence. Few studies have investigated the neurobiology of persecutory delusions, which is a prerequisite for developing novel treatments. The aim of this two-paradigm functional magnetic resonance imaging (fMRI) study is to characterize social “real world” and linguistic threat brain activations linked to persecutory delusions in schizophrenia (n=26) using instructed-fear/safety and emotional word paradigms. Instructed-fear/safety activations correlated to persecutory delusion severity demonstrated significant increased lateral orbitofrontal cortex and visual association cortex activations for the instructed-fear vs. safety and instructed-fear vs. baseline contrasts; decreased lateral orbitofrontal cortex and ventral occipital-temporal cortex activations were observed for the instructed-safety stimuli vs. baseline contrast. The salience network also showed divergent fear and safety cued activations correlated to persecutory delusions. Emotional word paradigm analyses showed positive correlations between persecutory delusion severity and left-lateralized linguistic and hippocampal-parahippocampal activations for the threat vs. neutral word contrast. Visual word form area activations correlated positively with persecutory delusions for both threat and neutral word vs. baseline contrasts. This study links persecutory delusions to enhanced neural processing of threatening stimuli and decreased processing of safety cues, and helps elucidate systems-level activations associated with persecutory delusions in schizophrenia. PMID:26208746

  19. Dermal safety study with imidacloprid/moxidectin topical solution in the ivermectin-sensitive collie.

    PubMed

    Paul, A J; Hutchens, D E; Firkins, L D; Borgstrom, M

    2004-05-26

    A study was conducted to determine the safety of the dermal application of 10% imidacloprid/2.5% moxidectin topical solution in ivermectin-sensitive collies. Each milliliter of this solution contains 100mg of imidacloprid and 25mg of moxidectin. A total of 21 collies were prescreened for ivermectin-sensitivity and heartworm negative status prior to selection for the study. Animals were assigned based on the maximum ivermectin-sensitivity score demonstrated during the prestudy screening. Treatment groups included a 3x and 5x test article group, and a 3x and 5x mineral oil control group. The 3x and 5x doses were administered at three and five times, respectively, the 1x dose based on the animal's body weight. On day 0, 3 of the 21 dogs were treated with dermal applications of a preliminary dose of 3x test article to screen for unexpected signs of toxicity with the remaining 18 dogs being treated with 3x mineral oil to blind for the volume of liquid applied. After no signs of toxicity were observed, these same three dogs were treated with 3x of test article and 2x mineral oil on days 28 and 56. The remaining 18 animals were equally allocated to either a 5x test article group or a 5x control group and were each treated on days 28, 56, and 84. Personnel performing observations were blinded to treatment. Observations were made for clinical signs of ivermectin sensitivity twice daily during non-dosing days. On treatment days, dogs were observed hourly for the first 4h post-treatment and at 6, 8, 12, 18 and 24h. Signs of toxicosis were not observed in any of the dogs throughout the observation period. This study demonstrated the safety of imidacloprid/moxidectin, when administered to collies testing positive for ivermectin sensitivity at dosages up to five times the maximum recommended dose.

  20. 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.

  1. [The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies].

    PubMed

    von Elm, Erik; Altman, Douglas G; Egger, Matthias; Pocock, Stuart J; Gøtzsche, Peter C; Vandenbroucke, Jan P

    2008-01-01

    Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalisability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case-control, and cross-sectional studies. We convened a 2-day workshop in September, 2004, with methodologists, researchers, and journal editors to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE statement) that relate to the title, abstract, introduction, methods, results, and discussion sections of articles. 18 items are common to all three study designs and four are specific for cohort, case-control, or cross-sectional studies. A detailed explanation and elaboration document is published separately and is freely available on the websites of PLoS Medicine, Annals of Internal Medicine, and Epidemiology. We hope that the STROBE statement will contribute to improving the quality of reporting of observational studies.

  2. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies.

    PubMed

    von Elm, Erik; Altman, Douglas G; Egger, Matthias; Pocock, Stuart J; Gøtzsche, Peter C; Vandenbroucke, Jan P

    2014-12-01

    Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalisability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case-control, and cross-sectional studies. We convened a 2-day workshop in September 2004, with methodologists, researchers, and journal editors to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE Statement) that relate to the title, abstract, introduction, methods, results, and discussion sections of articles. 18 items are common to all three study designs and four are specific for cohort, case-control, or cross-sectional studies. A detailed Explanation and Elaboration document is published separately and is freely available on the Web sites of PLoS Medicine, Annals of Internal Medicine, and Epidemiology. We hope that the STROBE Statement will contribute to improving the quality of reporting of observational studies.

  3. Observational and Modeling Study of Mesopheric Bores

    NASA Astrophysics Data System (ADS)

    Loughmiller, P.; Kelley, M.; Hickey, M.

    In our studies of the dynamics of the upper atmosphere, some of the most intriguing mesospheric phenomena we observe high over the Hawaiian night skies are internal bores. These events affecting chemiluminescence are documented in monochromatic airglow images taken by high performance all-sky CCD imaging systems operating at the Maui Space Surveillance Site on top of Haleakala Crater. Data is collected as part of the ongoing, collaborative Maui - Mesosphere and Lower Thermosphere (MALT) campaign, jointly sponsored by the National Science Foundation and the Air Force Office of Scientific Research. Bolstered by the Maui-MALT dataset, several theories now exist for mesospheric bores, agreeing in principle that they are likely nonlinear structures spawned by gravity waves and propagating within ducted waveguide regions, such as thermal inversion layers. A new investigation will model optical emissions using a robust, time-dependent, chemical dynamics model to explore the airglow response to ducted gravity waves and, in turn, the geographical and vertical coupling relationships which may exist.

  4. REFOS study: efficacy and safety of lanthanum carbonate in clinical practice in Spain.

    PubMed

    Torregrosa, José-Vicente; González-Parra, Emilio; González, M Teresa; Cannata-Andía, Jorge

    2014-05-21

    Lanthanum carbonate is a powerful phosphate binder that has shown efficacy and safety in clinical trials for hyperphosphataemia management, although there are few data in regular clinical practice. The study's objective was to evaluate, in regular clinical practice, its efficacy and safety in patients on dialysis. We retrospectively collected data from 15 months of monitoring, corresponding to 3 months prior to the start of treatment with lanthanum carbonate until 12 months after the start. Results included values of serum calcium, phosphorus, alkaline phosphatase, iPTH, hepatic enzymes and haemogram, as well as the daily-prescribed dose of lanthanum carbonate, the concomitant medication, treatment compliance and adverse events. 647 patients were included of which 522 completed the study. Abandonment, for the most part, was due to gastrointestinal disorders (26%) and hypophosphatemia (19%). Serum phosphorus decreased from 6.4±1.7 mg/dl (start) to 4.9±1.4 mg/dl (12 months) (P<.001). At the end of the monitoring period, 47% were within the desired phosphorus range (3.5-5mg/dl). There were no significant variations in the remaining parameters. Initial dose of lanthanum carbonate: 1900 mg/day; and end dose: 2300 mg/day. The variables independently associated with phosphataemia were baseline serum phosphorus and treatment compliance. In relation to safety, we observed 238 slight or moderate adverse effects in 117 patients, with 88% linked to gastrointestinal abnormalities. In conclusion, lanthanum carbonate reduces the serum phosphorus values in patients on dialysis with a good safety profile and acceptable adherence to that profile, with gastrointestinal disorders being the most frequent adverse effect.

  5. 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.

  6. Clinical Safety-in-Use Study of a New Tampon Design

    PubMed Central

    Jones, Michaelle B.; Hochwalt, Anne E.; Sarbaugh, Frank C.; Nunn, Stephen

    2003-01-01

    Objective: To confirm the safety of a new experimental Tampax® tampon and applicator compared with that of a currently marketed Tampax® tampon and applicator using comprehensive gynecological and microbiological assessments. Methods: A 2-month, single-blind, randomized, crossover study was conducted in which each subject served as her own control. Safety was evaluated by comparing potential product-related irritation (using colposcopic examination and subject diary data), assessment of vaginal discharge, vaginal pH, and effects on selected microorganisms (yeast, Escherichia coli ,Staphylococcus aureus and group B streptococci) obtained by vaginal swab cultures after normal menstrual use in the experimental and control groups. Results: In total, 110 women completed the study. There were no significant differences between the groups that used either the experimental or control tampon with regard to prevalence or mean cell density for the selected microorganisms. No differences were observed in the incidence or severity of erythema, in abrasion or ulceration of the cervix, vagina, introitus, vulva or perineum, or in mean vaginal pH and discharge assessments. There were equivalent low incidences of reported symptoms such as discomfort during insertion, wear or removal, and a similar low incidence of burning, stinging or itching during use of either the control or experimental tampon. There was a more favorable overall product rating for the experimental tampon (p = 0.003). Conclusions: This approach provides a combination of gynecological, microbiological and self-reported (diary recall) methodologies in order to assess tampon safety during use more thoroughly than has previously been reported, and it supports a comparable safety profile for the experimental tampon and a currently marketed tampon. PMID:14627214

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

    PubMed

    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% CO2-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.

  8. Studying evolved stars with Herschel observations

    NASA Astrophysics Data System (ADS)

    da Silva Santos, João Manuel

    2016-07-01

    A systematic inspection of the far-infrared (FIR) properties of evolved stars allows not only to constrain physical models, but also to understand the chemical evolution that takes place in the end of their lives. In this work we intend to study the circumstellar envelopes (CSE) on a sample of stars in the THROES catalogue from AGB/post-AGB stars to planetary nebulae using photometry and spectroscopy provided by the PACS instrument on-board Herschel telescope. In the first part we are interested in obtaining an estimate of the size of FIR emitting region and to sort our targets in two classes: point-like and extended. Secondly, we focus on the molecular component of the envelope traced by carbon monoxide (CO) rotational lines. We conduct a line survey on a sample of evolved stars by identifying and measuring flux of both 12CO and 13CO isotopologues in the PACS range, while looking at the overall properties of the sample. Lastly, we will be interested in obtaining physical parameters of the CSE, namely gas temperature, mass and mass-loss rate on a sample of carbon stars. For that, we make use of PACS large wavelength coverage, which enables the simultaneous study of a large number of CO transitions, to perform the rotational diagram analysis. We report the detection of CO emission in a high number of stars from the catalogue, which were mostly classified as point-like targets with a few exceptions of planetary nebulae. High J rotational number transitions were detected in a number of targets, revealing the presence of a significant amount of hot gas (T ˜ 400-900 K) and high mass-loss rates. We conclude that Herschel/PACS is in a privileged position to detect a new population of warmer gas, typically missed in sub-mm/mm observations.

  9. Novae a theoretical and observational study

    NASA Astrophysics Data System (ADS)

    Soraisam, Monika D.

    2016-02-01

    In this thesis, we present studies relating to novae that include both theoretical and ob- servational aspects. Being hosted by accreting white dwarfs (WDs), they have drawn attention in the context of the supernova Ia (SN Ia) progenitor problem. In the case of the nova explosion, the WD host is not disrupted. Instead, it continues to supply energy, even after the optical outbust, via stable nuclear burning of the remnant hydrogen envelope that survived the outburst. Accordingly, nova emission progresses toward the harder part of the electromagnetic spectrum, where it lasts longer than in the optical regime. As a consequence, novae are found to constitute the majority of the observed supersoft X-ray sources (SSSs). This is particularly well established for the galaxy M31. For high mass accretion rates in the unstable nuclear burning regime (or nova regime), there is evidence that significant mass accumulation by the WD is possible. This paved the way for SN Ia progenitor models in the single degenerate (SD) scenario involving novae. Based on the statistics of novae in M31, which is the most frequently used target for nova surveys, we investigate the role that novae may play in producing SNe Ia. Using multicycle nova evolution models and the observationally inferred nova rate in M31, we estimate the maximal SN Ia rate that novae can produce, assuming that all of the involved WDs reach the Chandrasekhar mass. Comparing this rate to the observationally inferred SN Ia rate for M31 constrains the contribution of the nova channel to the SN Ia rate to 2-7%. Additionally, we demonstrate that a more powerful diagnostic can be obtained from statistics of fast novae, which are characterized by decline times t2 10 days. Most novae resulting from a typical SD SN Ia progenitor accreting in the nova regime are fast. Specifically, as the WD in the nova grows in mass, it produces novae more frequently and with decreasing decline times. We therefore investigate how efficiently fast

  10. 75 FR 42455 - Safety and Occupational Health Study Section: Notice of Charter Renewal

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-21

    ... 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 and... Health Study Section, Department of Health and Human Services, 1600 Clifton Road, NE., Mailstop...

  11. When the Safety System Fails the Worker: Did We Do Our Job?...A Case Study

    SciTech Connect

    McConnell, S

    2006-02-03

    As safety professionals, we strive to implement a robust safety process in our organizations to maximize worker protection. We sell our philosophy and ideas to senior management, and then work with line management and the work force to develop and implement the safety process. Through this effort, we are likely to accomplish two major objectives. First, we obtain buy-in from line management and the workers, maybe even ownership for the safety process we implement. Second, we increase the likelihood that the hazards (and necessary controls) associated with the work activities performed by our workforce are identified and addressed by the safety process we implement. Our ambition is to maximize safety and health in the work place, and prevent injuries. Realizing this goal improves overall business operations. Petersen suggests an accident is an indication of something wrong in the management system (Petersen, pg 15). Successful organizations operate with the safety process fully integrated into the management system. If the management system fails, the safety process has failed the worker. As safety professionals, we must ask ourselves whether we did our job adequately. The better organizations strive for continuous improvement. The overall success of safety processes, in terms of accident and injury prevention has improved since safety professionals have learned to involve line management and the workers in the process. Although we maintain the label of 'safety expert', our role has shifted somewhat to that of a 'facilitator' in the process. The role of the safety professional is to advise and counsel line management (Kohn & Ferry, pg 28). Line management owns safety! If you subscribe to this philosophy, our role of advisor to line management makes perfect sense. Most safety professionals no longer operate as the 'safety cop'. That role belongs to line management. Instead, our role falls into the category of 'oversight' or facilitator. We observe systems, processes

  12. A study of the noncompliance of blood banks on safety and quality parameters in blood donation camps in Bengaluru

    PubMed Central

    Agarwal, Rajat Kumar; Dhanya, Rakesh; Parmar, Lalith G.; Vaish, Arpit; Sedai, Amit; Periyavan, Sundar

    2015-01-01

    Aims: The compliance of safety and quality parameters laid out by national and international guidelines in outdoor blood donation camps has not been studied in India. Our study aimed at identifying, monitoring, analyzing, and developing preventive strategies for several key parameters associated with the quality and safety of outdoor voluntary blood donation camps (VBDC). Settings: The study covered a total of 424 VBDCs at various locations in Bengaluru, Karnataka (South India) from 2009 to 2013. Seven government hospitals based blood banks, three private hospitals based blood banks and two voluntary standalone blood banks participated in the VBDCs included in the study. Materials and Methods: At the onset, the quality and safety standards to be followed were discussed and agreed upon. During the study, noncompliance (NC) to the agreed upon standards were recorded and shared. Periodic trainings were also organized to help minimize NC. Results: One or more instances of NC in 73% of the VBDCs. Highest NC were observed associated with punctuality (34%), wearing gloves (16%), hemoglobin (Hb) estimation (11%) and donor screening and selection other than Hb check (8-9%). Conclusion: For all 16 parameters under study, significant NC was observed. As a whole private hospital based blood banks were more noncompliant. The high degree of NC to matters relating to quality and safety in VBDCs is high and warrants for urgent attention and further study. Our study also shows that regular monitoring and systematic and strategic intervention can decrease the rate of NC. PMID:25722568

  13. 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…

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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

  19. Improving outpatient safety through effective electronic communication: a study protocol

    PubMed Central

    Hysong, Sylvia J; Sawhney, Mona K; Wilson, Lindsey; Sittig, Dean F; Esquivel, Adol; Watford, Monica; Davis, Traber; Espadas, Donna; Singh, Hardeep

    2009-01-01

    Background Health information technology and electronic medical records (EMRs) are potentially powerful systems-based interventions to facilitate diagnosis and treatment because they ensure the delivery of key new findings and other health related information to the practitioner. However, effective communication involves more than just information transfer; despite a state of the art EMR system, communication breakdowns can still occur. [1-3] In this project, we will adapt a model developed by the Systems Engineering Initiative for Patient Safety (SEIPS) to understand and improve the relationship between work systems and processes of care involved with electronic communication in EMRs. We plan to study three communication activities in the Veterans Health Administration's (VA) EMR: electronic communication of abnormal imaging and laboratory test results via automated notifications (i.e., alerts); electronic referral requests; and provider-to-pharmacy communication via computerized provider order entry (CPOE). Aim Our specific aim is to propose a protocol to evaluate the systems and processes affecting outcomes of electronic communication in the computerized patient record system (related to diagnostic test results, electronic referral requests, and CPOE prescriptions) using a human factors engineering approach, and hence guide the development of interventions for work system redesign. Design This research will consist of multiple qualitative methods of task analysis to identify potential sources of error related to diagnostic test result alerts, electronic referral requests, and CPOE; this will be followed by a series of focus groups to identify barriers, facilitators, and suggestions for improving the electronic communication system. Transcripts from all task analyses and focus groups will be analyzed using methods adapted from grounded theory and content analysis. PMID:19781075

  20. 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

  1. 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.

  2. 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…

  3. 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…

  4. A cross-cultural study of organizational factors on safety: Japanese vs. Taiwanese oil refinery plants.

    PubMed

    Hsu, Shang Hwa; Lee, Chun-Chia; Wu, Muh-Cherng; Takano, Kenichi

    2008-01-01

    This study attempts to identify idiosyncrasies of organizational factors on safety and their influence mechanisms in Taiwan and Japan. Data were collected from employees of Taiwanese and Japanese oil refinery plants. Results show that organizational factors on safety differ in the two countries. Organizational characteristics in Taiwanese plants are highlighted as: higher level of management commitment to safety, harmonious interpersonal relationship, more emphasis on safety activities, higher devotion to supervision, and higher safety self-efficacy, as well as high quality of safety performance. Organizational characteristics in Japanese plants are highlighted as: higher level of employee empowerment and attitude towards continuous improvement, more emphasis on systematic safety management approach, efficient reporting system and teamwork, and high quality of safety performance. The casual relationships between organizational factors and workers' safety performance were investigated using structural equation modeling (SEM). Results indicate that the influence mechanisms of organizational factors in Taiwan and Japan are different. These findings provide insights into areas of safety improvement in emerging countries and developed countries respectively.

  5. 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

  6. 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

  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.

  8. 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.

  9. Case study: on the leading edge of new curricula concepts: systems and safety in nursing education.

    PubMed

    Dick, Diana Davidson; Weisbrod, Lorna; Gregory, David; Dyck, Netha; Neudorf, Kim

    2006-09-01

    The Nursing Division of the Saskatchewan Institute of Applied Science and Technology (SIAST) first included systems and patient safety as a priority in its institutional business and strategic plan in 2003. Three interrelated leading-edge, two-year projects (2004-2006) were launched: Best Practice, Mentorship and Patient Safety, with the intent that each project would enhance the others. This case study focuses on the work of the Patient Safety Project Team. The team developed a project framework and strategic plan, conducted a literature review and identified key concepts related to systems and patient safety. Strategies to integrate these concepts into the school's 15 nursing education programs are being implemented.

  10. 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

  11. 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

  12. Mathematical Modeling Tools to Study Preharvest Food Safety.

    PubMed

    Lanzas, Cristina; Chen, Shi

    2016-08-01

    This article provides an overview of the emerging field of mathematical modeling in preharvest food safety. We describe the steps involved in developing mathematical models, different types of models, and their multiple applications. The introduction to modeling is followed by several sections that introduce the most common modeling approaches used in preharvest systems. We finish the chapter by outlining potential future directions for the field.

  13. Attitudes and knowledge toward natural products safety in the pharmacy setting: an Italian study.

    PubMed

    Cuzzolin, Laura; Benoni, Giuseppina

    2009-07-01

    The lack of a professional supervision may expose consumers of natural products to risks; pharmacists play an important role in giving information about these substances. A survey was designed to investigate the attitudes and knowledge of consumers and pharmacists toward the safety of natural products. Twenty-three pharmacies participated in the project. On the basis of a pre-structured 17-item questionnaire, face-to-face interviews were conducted with consumers buying a natural product over a 6-month period. A further 8 items had to be compiled by pharmacists about the purchased product. During the study period, 1420 interviews were carried out. The most frequently purchased products were echinacea, propolis, garlic, guggul, ginkgo, liquorice, ginseng, glucomannan, guarana, valerian, and passionflower; 71.8% of consumers reported to have been taking conventional medicines along with natural products. Some (3.9%) referred to adverse effects in the last year: allergic reactions after cartilage of shark, propolis and thyme; anxiety after hypericum; hypotension and tachycardia after a mix containing chamomile, valerian and melissa; pyrosis and stomach-ache after laxative-depurative herbs. Pharmacists referred to some adverse effects observed in the past in relation to the products bought by consumers involved in this study. Findings from this study demonstrate that in general consumers need information on herbal safety and pharmacists are more likely to answer correctly about the use of herbs rather than about cautions, adverse effects and interactions.

  14. 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.

  15. 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…

  16. 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.

  17. 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.

  18. 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

  19. 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

  20. Polyprenyl Immunostimulant in Feline Rhinotracheitis: Randomized Placebo-Controlled Experimental and Field Safety Studies

    PubMed Central

    Legendre, Alfred M.; Kuritz, Tanya; Heidel, Robert Eric; Baylor, Vivian M.

    2017-01-01

    Feline rhinotracheitis is a ubiquitous disease caused by feline herpesvirus type 1 (FHV-1). The disease is easily transmissible and common in multi-cat environments where even vaccinated cats can develop clinical signs of respiratory or ocular disease or both when exposed to the virus. Prior to the work reported here, there was no licensed treatment for the disease on the market. We hypothesized that polyprenyl immunostimulant (PI), an immunomodulatory veterinary biologic, would be useful in treating feline rhinotracheitis by reducing the severity of respiratory or/and ocular disease. We conducted double-blinded, randomized, placebo-controlled clinical trials in experimentally infected cats to establish the efficacy of PI. Specific pathogen-free cats were administered a placebo (n = 20) or PI (n = 20) starting on the day of FHV-1 experimental challenge. Trained, masked observers applied a standardized scoring system daily in clinical examinations for 14 days after the FHV-1 challenge. The cats treated with PI had significantly lower disease severity scores over the course of the experiment compared to the cats in the placebo group (p = 0.05). The safety studies, including a field safety study involving 390 owned cats in 10 states, showed that PI was safe to use in cats as young as 8 weeks of age. PMID:28289684

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Driving violations observed: an Australian study.

    PubMed

    Glendon, A Ian

    2007-08-01

    This study analyses 2,765 cases of driving behaviours in three Australian states - New South Wales, Queensland and Victoria. Data were gathered from in-car coordinated video and audio recording sequences in free-flowing traffic along two-, three- and four-lane highways with varying speed limits on all days of the week in daylight and fine weather conditions. Explanatory variables included driver age group and gender, passenger characteristics and vehicle age and type. Response variables included driving violations and other driving behaviours, including lane use, speeding, close following (tailgating), driver's hands position and mobile phone use. Data were analysed qualitatively and quantitatively. By focusing upon vehicle and driver characteristics, and their impact on driving behaviours, including identified violations, this study explores some implications both for future research and for traffic policy makers.

  9. Hand Safety

    MedlinePlus

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

  10. 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.

  11. Ferrocyanide safety program cyanide speciation studies FY 1993 annual report

    SciTech Connect

    Bryan, S.A.; Pool, K.H.; Bryan, S.L.; Sell, R.L.; Thomas, L.M.P.

    1993-09-01

    This report summarizes Pacific Northwest Laboratory`s (PNL) FY 1993 progress toward developing and implementing methods to identify and quantify cyanide species in ferrocyanide tank waste. Currently, there are 24 high-level waste storage tanks at the US Department of Energy`s (DOE) Hanford Site that have been placed on a Ferrocyanide Tank Watchlist because they contain an estimated 1000 g-moles or more of precipitated ferrocyanide. This amount of ferrocyanide is of concern because the consequences of a potential explosion may exceed those reported previously in safety analyses. To bound the safety concern, methods are needed to definitively measure and quantitate the amount of ferrocyanides present within actual waste tanks to a lower limit of at least 0.1 wt % up to approximately 15 wt %. The target analyte concentration for cyanide in waste is approximately 0.1 to 15 wt % (as CN) in the original undiluted sample. After dissolution of the original sample and appropriate dilutions, the concentration range of interest in the analytical solutions can vary between 0.001 to 0.1 wt % (as CN).

  12. [Agreement between two observers in the measurement of smoking and use of safety belt and cell phones in vehicles].

    PubMed

    Martínez-Sánchez, Jose M; Curto, Ariadna; Fernández, Esteve

    2012-01-01

    The aim of this study was to assess the feasibility of direct observations of smoking and use of seat belts and cell phones in drivers in the city of Barcelona, and to analyze the agreement between two observers. We performed 315 pairs of observations. The simple percentage inter-observer agreement between driver and passenger smoking was 100% with a Kappa coefficient=1.0. There was high inter-observer agreement in measurement of cell phone use and the number of passengers aged less than 14 years old. The variable with the lowest agreement was the driver's age. In conclusion, direct observation studies are a good resource for monitoring smoking and use of seat belts and cell phones in the drivers of motor vehicles.

  13. 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.

  14. Non-clinical studies in the process of new drug development - Part II: Good laboratory practice, metabolism, pharmacokinetics, safety and dose translation to clinical studies.

    PubMed

    Andrade, E L; Bento, A F; Cavalli, J; Oliveira, S K; Schwanke, R C; Siqueira, J M; Freitas, C S; Marcon, R; Calixto, J B

    2016-12-12

    The process of drug development involves non-clinical and clinical studies. Non-clinical studies are conducted using different protocols including animal studies, which mostly follow the Good Laboratory Practice (GLP) regulations. During the early pre-clinical development process, also known as Go/No-Go decision, a drug candidate needs to pass through several steps, such as determination of drug availability (studies on pharmacokinetics), absorption, distribution, metabolism and elimination (ADME) and preliminary studies that aim to investigate the candidate safety including genotoxicity, mutagenicity, safety pharmacology and general toxicology. These preliminary studies generally do not need to comply with GLP regulations. These studies aim at investigating the drug safety to obtain the first information about its tolerability in different systems that are relevant for further decisions. There are, however, other studies that should be performed according to GLP standards and are mandatory for the safe exposure to humans, such as repeated dose toxicity, genotoxicity and safety pharmacology. These studies must be conducted before the Investigational New Drug (IND) application. The package of non-clinical studies should cover all information needed for the safe transposition of drugs from animals to humans, generally based on the non-observed adverse effect level (NOAEL) obtained from general toxicity studies. After IND approval, other GLP experiments for the evaluation of chronic toxicity, reproductive and developmental toxicity, carcinogenicity and genotoxicity, are carried out during the clinical phase of development. However, the necessity of performing such studies depends on the new drug clinical application purpose.

  15. Non-clinical studies in the process of new drug development - Part II: Good laboratory practice, metabolism, pharmacokinetics, safety and dose translation to clinical studies

    PubMed Central

    Andrade, E.L.; Bento, A.F.; Cavalli, J.; Oliveira, S.K.; Schwanke, R.C.; Siqueira, J.M.; Freitas, C.S.; Marcon, R.; Calixto, J.B.

    2016-01-01

    The process of drug development involves non-clinical and clinical studies. Non-clinical studies are conducted using different protocols including animal studies, which mostly follow the Good Laboratory Practice (GLP) regulations. During the early pre-clinical development process, also known as Go/No-Go decision, a drug candidate needs to pass through several steps, such as determination of drug availability (studies on pharmacokinetics), absorption, distribution, metabolism and elimination (ADME) and preliminary studies that aim to investigate the candidate safety including genotoxicity, mutagenicity, safety pharmacology and general toxicology. These preliminary studies generally do not need to comply with GLP regulations. These studies aim at investigating the drug safety to obtain the first information about its tolerability in different systems that are relevant for further decisions. There are, however, other studies that should be performed according to GLP standards and are mandatory for the safe exposure to humans, such as repeated dose toxicity, genotoxicity and safety pharmacology. These studies must be conducted before the Investigational New Drug (IND) application. The package of non-clinical studies should cover all information needed for the safe transposition of drugs from animals to humans, generally based on the non-observed adverse effect level (NOAEL) obtained from general toxicity studies. After IND approval, other GLP experiments for the evaluation of chronic toxicity, reproductive and developmental toxicity, carcinogenicity and genotoxicity, are carried out during the clinical phase of development. However, the necessity of performing such studies depends on the new drug clinical application purpose. PMID:27982281

  16. Safety assessment of dietary bamboo charcoal powder: a 90-day subchronic oral toxicity and mutagenicity studies.

    PubMed

    Zhenchao, Jia; Yuting, Zhong; Jiuming, Yan; Yedan, Lu; Yang, Song; Jinyao, Chen; Lishi, Zhang

    2015-01-01

    Vegetable carbon has been used as food additive in EU (E153) and China for many years; however, no experimental data have been available on its dietary safety. This study was designed to evaluate the subchronic toxicity and genotoxicity of bamboo charcoal powder (BCP). In the study of subchronic oral toxicity, BCP was administered orally at doses of 2.81, 5.62, and 11.24 g/kg BW for 90 days to SD rats. Additional satellite groups from the control group and high dose group were observed for a 28-day recovery period. At the end of the treatment and recovery periods, animals were sacrificed, and their organs were weighed and blood samples were collected. The toxicological endpoints observed included clinical signs, food consumption, body and organ weights, hematological and biochemical parameters, macroscopic and microscopic examinations. The results showed no significant differences between the BCP treated groups and control group. The genotoxicity of BCP was assessed with the Salmonella typhimurium mutagenicity assay (Ames test) and a combination of comet assay and mammalian erythrocyte micronucleus protocol. The results did not reveal any genotoxicity of BCP. Based on our study, the no-observed-adverse-effect level (NOAEL) for BCP is 11.24 g/kg BW/day.

  17. 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

    ... feasible standards for the capability of such systems to detect leaks, and the safety benefits and adverse... methods and systems that range from visual inspection techniques, instrumented monitoring of internal... Pipeline and Hazardous Materials Safety Administration Pipeline Safety: Public Comment on Leak and...

  18. Vessel traffic safety in busy waterways: A case study of accidents in western shenzhen port.

    PubMed

    Mou, J M; Chen, P F; He, Y X; Yip, Tsz Leung; Li, W H; Tang, J; Zhang, H Z

    2016-08-03

    Throughout the world, busy waterways near large ports witness heavy vessel traffic in recent decades. The waterways are characterized by high risk in terms of loss of life, property, and pollution to environment. To facilitate maritime safety management with satisfactory efficiency and efficacy, the authors propose a framework of safety indexes to evaluate the risk level in busy waterways according to the accident severity, fatality rate and special indicators of maritime transportation. The safety indexes consist of Safety Evaluation Index (SEI) and Safety Warning Index (SWI), and are derived from the proposed risk criteria of Chinese vessel traffic. As a case study, data on vessel traffic accidents reported in the Western Shenzhen Port, South China from 1995 to 2015 are analyzed. The actual risk level of this area during the period is calculated under the framework. The implementation of the safety indexes indicate that the risk criteria and safety indexes are practicable and effective for the vessel traffic management. The methodology based on long-term accident data can significantly support the risk analysis in the macroscopic perspective for busy ports and waterways, such that SWI can act as threshold to trigger actions, while SEI can act as an indicator to measure safety status.

  19. Safety evaluation of BacoMind in healthy volunteers: a phase I study.

    PubMed

    Pravina, K; Ravindra, K R; Goudar, K S; Vinod, D R; Joshua, A J; Wasim, P; Venkateshwarlu, K; Saxena, V S; Amit, A

    2007-05-01

    BacoMind is an enriched phytochemical composition of Bacopa monniera (B. monniera), a common medicinal plant used in the traditional systems of medicine as a memory-enhancing agent. BacoMind was standardized with reference to bioactive compounds and was evaluated for short-term safety and tolerability in healthy adult volunteers. The study plan employed randomized, open label, dose escalation design. Each of 23 participants were orally given one single capsule of BacoMind daily for 30 days, i.e., 300 mg for first 15 days and 450 mg for next 15 days. Detailed examination of clinical, hematological, biochemical and electrocardiographic parameters done in pre and post-treatment periods did not indicate any untoward effects in any of the treated volunteers. Mild adverse events related to gastrointestinal system were observed in the trial, which subsided spontaneously. BacoMind was found to meet the safety criteria at the dose administered for the given duration of trial period in healthy adult volunteers.

  20. Multi-scale traffic safety and operational performance study of large trucks on mountainous interstate highway.

    PubMed

    Chen, Suren; Chen, Feng; Wu, Jun

    2011-01-01

    In addition to multi-vehicle accidents, large trucks are also prone to single-vehicle accidents on the mountainous interstate highways due to the complex terrain and fast-changing weather. By integrating both historical data analysis and simulations, a multi-scale approach is developed to evaluate the traffic safety and operational performance of large trucks on mountainous interstate highways in both scales of individual vehicle as well as traffic on the whole highway. A typical mountainous highway in Colorado is studied for demonstration purposes. Firstly, the ten-year historical accident records are analyzed to identify the accident-vulnerable-locations (AVLs) and site-specific critical adverse driving conditions. Secondly, simulation-based single-vehicle assessment is performed for different driving conditions at those AVLs along the whole corridor. Finally, the cellular-automaton (CA)-based simulation is carried out to evaluate the multi-vehicle traffic safety as well as the operational performance of the traffic by considering the actual speed limits, including the differential speed limits (DSL) at some locations. It is found that the multi-scale approach can provide insightful and comprehensive observations of the highway performance, which is especially important for mountainous highways.

  1. 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.

  2. Usability, Participant Acceptance, and Safety of a Prefilled Insulin Injection Device in a 3-Month Observational Survey in Everyday Clinical Practice in Australia

    PubMed Central

    Carter, John; Beilin, Jonathan; Morton, Adam; De Luise, Mario

    2009-01-01

    Background SoloSTAR® (SOL; sanofi-aventis, Paris, France) is a prefilled insulin pen device for the injection of insulin glargine and insulin glulisine. This is the first Australian survey to determine its usability, participant acceptance, and safety in clinical practice. Methods A 3-month, nonrandomized, noncomparative, observational survey in Australia was conducted in individuals with diabetes. Participants were given SOL pens containing glargine, the instruction leaflet, and a toll-free helpline number. Training was offered to all participants. Safety data, including product technical complaints (PTCs), were gathered from ongoing feedback given by the participant or health care professional (HCP) and by independent interviews conducted 6–10 weeks after study start. Results Some 2674 people consented to take part across 93 sites (150 HCPs), and 2029 participated in interviews. Of these, 52.6% had type 1 diabetes, 16.3% had manual dexterity problems, and 15.5% had poor eyesight not corrected by glasses. At the time of interview, 96.8% of participants were still using SOL. None of the eight PTCs reported were due to technical defects; most were related to handling errors. Some 62 participants reported 77 adverse events; none were related to a PTC. The vast majority of participants (95.4%) were “very satisfied” or “satisfied” with using SOL, and 89.7% of the participants had no questions or concerns using SOL on a daily basis. Similar positive findings were reported by participants with manual or dexterity impairments. Conclusions In this survey of everyday clinical practice, SOL had a good safety profile and was very well accepted by participants. PMID:20144398

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

    PubMed

    Goh, Yang Miang; Askar Ali, Mohamed Jawad

    2016-08-01

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

  4. Non-clinical models: validation, study design and statistical consideration in safety pharmacology.

    PubMed

    Pugsley, M K; Towart, R; Authier, S; Gallacher, D J; Curtis, M J

    2010-01-01

    The current issue of the Journal of Pharmacological and Toxicological Methods (JPTM) focuses exclusively on safety pharmacology methods. This is the 7th year the Journal has published on this topic. Methods and models that specifically relate to methods relating to the assessment of the safety profile of a new chemical entity (NCE) prior to first in human (FIH) studies are described. Since the Journal started publishing on this topic there has been a major effort by safety pharmacologists, toxicologists and regulatory scientists within Industry (both large and small Pharma as well as Biotechnology companies) and also from Contract Research Organizations (CRO) to publish the surgical details of the non-clinical methods utilized but also provide important details related to standard and non-standard (or integrated) study models and designs. These details from core battery and secondary (or ancillary) drug safety assessment methods used in drug development programs have been the focus of these special issues and have been an attempt to provide validation of methods. Similarly, the safety pharmacology issues of the Journal provide the most relevant forum for scientists to present novel and modified methods with direct applicability to determination of drug safety-directly to the safety pharmacology scientific community. The content of the manuscripts in this issue includes the introduction of additional important surgical methods, novel data capture and data analysis methods, improved study design and effects of positive control compounds with known activity in the model.

  5. 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.

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

    PubMed

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

    2012-06-01

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

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

    PubMed

    Elvik, Rune

    2006-07-01

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

  8. A vaccine study design selection framework for the postlicensure rapid immunization safety monitoring program.

    PubMed

    Baker, Meghan A; Lieu, Tracy A; Li, Lingling; Hua, Wei; Qiang, Yandong; Kawai, Alison Tse; Fireman, Bruce H; Martin, David B; Nguyen, Michael D

    2015-04-15

    The Postlicensure Rapid Immunization Safety Monitoring Program, the vaccination safety monitoring component of the US Food and Drug Administration's Mini-Sentinel project, is currently the largest cohort in the US general population for vaccine safety surveillance. We developed a study design selection framework to provide a roadmap and description of methods that may be utilized to evaluate potential associations between vaccines and health outcomes of interest in the Postlicensure Rapid Immunization Safety Monitoring Program and other systems using administrative data. The strengths and weaknesses of designs for vaccine safety monitoring, including the cohort design, the case-centered design, the risk interval design, the case-control design, the self-controlled risk interval design, the self-controlled case series method, and the case-crossover design, are described and summarized in tabular form. A structured decision table is provided to aid in planning of future vaccine safety monitoring activities, and the data components comprising the structured decision table are delineated. The study design selection framework provides a starting point for planning vaccine safety evaluations using claims-based data sources.

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

    PubMed

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

    2016-02-01

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

  10. Joint modeling of clinical efficacy and safety with an application to diabetes studies.

    PubMed

    Zhao, Yang; Shen, Wei; Fu, Haoda

    2013-01-01

    The purpose of drug development is to evaluate a drug's efficacy and safety profile. For a personalized medicine, it is important for patients and health care providers to understand the efficacy and safety trade-off when selecting a dose for a patient. In this article, we propose three different methods for jointly modeling the clinical safety and efficacy endpoints. These three methods model the correlation relationship in three different ways: modeling the joint distribution by a copula method, modeling conditional distributions, and modeling their correlations through individual means by a hierarchical model. We compare these three methods through simulations and apply these methods to a data set from a diabetes study.

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

    SciTech Connect

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

    2008-07-15

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

  12. A Study on Performance and Safety Tests of Electrosurgical Equipment

    PubMed Central

    Tavakoli Golpaygani, A.; Movahedi, M.M.; Reza, M.

    2016-01-01

    Introduction: Modern medicine employs a wide variety of instruments with different physiological effects and measurements. Periodic verifications are routinely used in legal metrology for industrial measuring instruments. The correct operation of electrosurgical generators is essential to ensure patient’s safety and management of the risks associated with the use of high and low frequency electrical currents on human body. Material and Methods: The metrological reliability of 20 electrosurgical equipment in six hospitals (3 private and 3 public) was evaluated in one of the provinces of Iran according to international and national standards. Results: The achieved results show that HF leakage current of ground-referenced generators are more than isolated generators and the power analysis of only eight units delivered acceptable output values and the precision in the output power measurements was low. Conclusion: Results indicate a need for new and severe regulations on periodic performance verifications and medical equipment quality control program especially in high risk instruments. It is also necessary to provide training courses for operating staff in the field of meterology in medicine to be acquianted with critical parameters to get accuracy results with operation room equipment. PMID:27853725

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

    PubMed Central

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

    2016-01-01

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

  14. Active immunotherapy for cancer patients using tumor lysate pulsed dendritic cell vaccine: a safety study.

    PubMed

    Ovali, E; Dikmen, T; Sonmez, M; Yilmaz, M; Unal, A; Dalbasti, T; Kuzeyli, K; Erturk, M; Omay, S B

    2007-06-01

    Cancer vaccine therapy represents a promising therapeutical option. Consistently, with these new treatment strategies, the use of dendritic cell vaccines is becoming increasingly widespread and currently in the forefront for cancer treatment. The purpose of this study was to evaluate the feasibility and safety of tumor lysate-pulsed dendritic cell (DC) vaccine in patients with advanced cancers. For this purpose, eighteen patients with relapsed or refractory cancer were vaccinated with peripheral monocyte-derived DCs generated with GM-CSF and IL-4, and pulsed consequently with 100 microg/ml of tumor lysate before maturation in culture in the presence of IL-1beta, PGE2 and TNF alpha for two days. The first two vaccinations were given intradermally every two weeks while further injections were given monthly. Tumor lysate-pulsed dendritic cell injections were well-tolerated in all patients with no more than grade 1 injection-related toxicity. Local inflammatory response was mainly erythematous which subsided in 48 hrs time. No end organ toxicity or autoimmune toxicity was identified. Clinical responses observed in our study were satisfactory for a phase I clinical study. We observed 4 (22%) objective clinical responses. These responses are significantly correlated with delayed type hypersensitivity testing (DTH) (p < 0.01). The results showed that this active immunotherapy is feasible, safe, and may be capable of eliciting immune responses against cancer.

  15. Cross matching observations on toxicological and clinical data for the assessment of tolerability and safety of Ginkgo biloba leaf extract.

    PubMed

    Heinonen, Tuula; Gaus, Wilhelm

    2015-01-02

    Ginkgo biloba is one of the most widely used herbal remedies in Europe and the US. It may be purchased in different types of formulations, but most of the clinical studies have been performed with the controlled G. biloba extract EGb761(®). Indications include Alzheimers disease, cardiovascular disease, dementia, memory loss, and cerebral ischemia. The pharmacological modes of action cover antioxidant effects, radical scavenging, inhibition of platelet activating factor, alterations in membrane fluidity (signal transduction), and inhibition of glucocorticoid synthesis. Due to the widespread and long-term use of G. biloba - about a million doses of EGb761(®) are sold per day - tolerability and safety are a crucial issue. Based on broad and long-term clinical use of G. biloba extracts, it is regarded as well tolerated in man. Cross matching, a tool we introduced, combines different fields of knowledge and types of data to a consolidated result. In this article, we combine toxicological and clinical data and utilize other sources of information to assess tolerability and safety of G. biloba. It is well known that because of biological differences between animals and man or even between animal species, animal experiments do not necessarily mimic the effects in humans. Therefore, for adequate risk assessment, the relevance of non-clinical toxicological findings should be correlated with human data. The cross matching of toxicological data and results from clinical studies is possible because many toxicological and clinical studies are available on G. biloba. We give an in depth analysis of the modes of action in animals and describe toxicological studies with regard to metabolism, pharmacokinetics, genotoxicity, as well as carcinogenicity (e.g., the Technical Report TR 578 of the US National Toxicology Program). In addition, 75 clinical trials with high methodological quality are summarized. They included a total of 7115 patients treated with G. biloba. Based on this

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

    PubMed Central

    Pels, Anouk; Ganzevoort, Wessel

    2015-01-01

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

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

    SciTech Connect

    Brenchley, D.L.

    1981-06-01

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

  18. Safety in earth orbit study. Volume 4: Space shuttle orbiter: Safety requirements and guidelines on-orbit phase

    NASA Technical Reports Server (NTRS)

    1972-01-01

    Safety requirements and guidelines are listed for the space shuttle orbiter and for its interface with other vehicles. The requirements and guidelines are specific to the hazards and emergencies in earth orbit. The requirements and guidelines for the orbiter are those with respect to vehicle design, safety devices, warning devices, operational procedures, and residual hazards. The requirements and guidelines for interface with the space station, upper stage vehicles, and sortie payloads are imposed on these vehicles to ensure the safety of the shuttle orbiter. The rationale for the safety requirements and guidelines is also discussed.

  19. Criticality safety study of the MSRE auxiliary charcoal bed

    SciTech Connect

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

    1996-09-01

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

  20. 1985 NASA-Rockwell Space Station Crew Safety Study: results from Mir.

    PubMed

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

    2004-01-01

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

  1. Immunogenicity and safety of a tetravalent dengue vaccine in healthy adults in India: A randomized, observer-blind, placebo-controlled phase II trial.

    PubMed

    Dubey, Anand Prakash; Agarkhedkar, Sharad; Chhatwal, Jugesh; Narayan, Arun; Ganguly, Satyabrata; Wartel, T Anh; Bouckenooghe, Alain; Menezes, Josemund

    2016-01-01

    Dengue is a mosquito-borne viral disease that is endemic in India. We evaluated the immunogenicity and safety of recombinant, live-attenuated, tetravalent dengue vaccine (CYD-TDV) in Indian adults. In this observer-blind, randomized, placebo-controlled, Phase II study, adults aged 18-45 years were randomized 2:1 to receive CYD-TDV or placebo at 0, 6 and 12 months in sub-cutaneous administration. Immunogenicity was assessed using a 50% plaque reduction neutralization test (PRNT50) at baseline and 28 days after each study injection. 189 participants were enrolled (CYD-TDV [n = 128]; placebo, [n = 61]). At baseline, seropositivity rates for dengue serotypes 1, 2, 3 and 4 ranged from 77.0% to 86.9%. Seropositivity rates for each serotype increased after each CYD-TDV injection with a more pronounced increase after the first injection. In the CYD-TDV group, geometric mean titres (GMTs) were 2.38 to 6.11-fold higher after the third injection compared with baseline but remained similar to baseline in the placebo group. In the CYD-TDV group, the GMTs were 1.66 to 4.95-fold higher and 9.23 to 24.6-fold higher after the third injection compared with baseline in those who were dengue seropositive and dengue seronegative, respectively. Pain was the most commonly reported solicited injection site reaction after the first injection in both the CYD-TDV (6.3%) and placebo groups (4.9%), but occurred less frequently after subsequent injections. No serious adverse events were vaccine-related, no immediate unsolicited adverse events, and no virologically-confirmed cases of dengue, were reported during the study. The immunogenicity and safety of CYD-TDV was satisfactory in both dengue seropositive and seronegative Indian adults.

  2. [The hypertensive type II diabetic patient treated with captopril in free general practice (Austrian Safety Study). An indications study].

    PubMed

    Stanek, B; Basalka, E; Seitl, K; Fiser, I

    1997-01-01

    In 826 hypertensive patients including 396 with non-insulin dependent diabetes mellitus safety and efficacy of captopril 50 mg per day was evaluated throughout three months. In all patients blood pressure was significantly reduced. Moreover, in part of the patients with microalbuminuria, these tests turned negative with treatment. In addition, in patients with diabetes fasting and postprandial plasma glucose levels as well as HBA1C levels decreased. Only in 6.8% side effects occurred. In all patients quality of life as evaluated by a 10 item rating scale questionnaire improved. Taken together the results of this observational study confirm improvement of blood pressure levels, kidney function and metabolic derangements in diabetic patients treated with the ACE-inhibitor captopril. Effectiveness of these actions of captopril in respect to longterm prognosis in diabetics, however, remains to be established.

  3. Public attitudes towards motorcyclists' safety: a qualitative study from the United Kingdom.

    PubMed

    Musselwhite, Charles B A; Avineri, Erel; Susilo, Yusak O; Bhattachary, Darren

    2012-11-01

    The aim of the reported research was to examine the perceptions of road user safety amongst different road users and examine the link between attitudes, empathy and skill in motorcycle safety behaviour. Motorcyclists were perceived by the study participants, members of the public at four different locations at the UK (including motorcyclists and non-motorcyclists), as a group be at a high risk of accidents on the road. This was due to perceived behavioural characteristics of motorcyclists--who were viewed as 'thrill seekers'--as well as observed behaviours on the road. This, coupled with the physical vulnerability and excessive speeds, meant that motorbike driving was considered by the study participants as the least safe form of road use. There was broad agreement that motorcycling was dangerous as a whole, but not all motorcyclists were necessarily risky riders. The issue of 'competitive space' emerged between car drivers and motorcyclists in particular and it was suggested that there was a lack of mutual awareness and considerations between the two groups. Generally, greatest empathy comes from drivers who are motorcyclists themselves. Engineering, education, enforcement interventions were investigated. These were aimed at two main areas: normalising safer driving behaviours for motorcyclists and increasing awareness of bikes for motorists--particularly in relation to reducing speed limits at urban junctions. Finally, the idea of risk mapping and reduced speed limits on rural roads was seen as potentially effective--particularly as certain motorcyclists highlighted that they changed their riding behaviours by increasing speed and taking greater risks on these roads.

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

    NASA Technical Reports Server (NTRS)

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

    2012-01-01

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

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

    PubMed Central

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

    2012-01-01

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

  6. Safety in earth orbit study. Volume 5: Space shuttle payloads: Safety requirements and guidelines on-orbit phase

    NASA Technical Reports Server (NTRS)

    1972-01-01

    Safety requirements and guidelines are listed for the sortie module, upper stage vehicle, and space station for the earth orbit operations of the space shuttle program. The requirements and guidelines are for vehicle design, safety devices, warning devices, operational procedures, and residual hazards.

  7. A double-blind clinical safety study of noni fruit juice.

    PubMed

    West, Brett J; White, Leland D; Jensen, C Jarakae; Palu, Afa K

    2009-11-01

    A safety study of TAHITIAN NONI Juice from Tahiti was conducted with ninety-six healthy volunteers. For 28 days, participants consumed one of four daily quantities of noni juice: 0 mL (placebo), 30 mL, 300 mL, or 750 mL. All daily dose formulations were standardized to 750 mL by making up any volume differences with the placebo. Hematology, biochemistry, urinalysis, vital signs, and adverse events measurements were made at 0 (baseline), 2, and 4 weeks, as well as during a two-week follow up (week 6). Electrocardiogram (ECG) measurements were also made for each volunteer during the pre-study screen and at week 6. During the trial, those in the noni groups experienced 20 to 50% fewer total adverse events than those in the placebo group. A marginally significant (P<0.1) reduction in the number of constant adverse events experienced by the volunteers was also found in the 300 mL noni juice group. A similar trend was observed in the other noni juice groups, as well. No other clinically significant differences between any of the groups were noted in the parameters and measurements of this study, nor was there evidence suggesting any adverse dose-related effects. The results of this study indicate that drinking up to 750 mL TAHITIAN NONI Juice per day is safe.

  8. Intervention Effects on Safety Compliance and Citizenship Behaviors: Evidence from the Work, Family, and Health Study

    PubMed Central

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

    2015-01-01

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

  9. Preclinical safety evaluation of IQG-607 in rats: Acute and repeated dose toxicity studies.

    PubMed

    Rodrigues-Junior, Valnês S; Machado, Pablo; Calixto, João B; Siqueira, Jarbas M; Andrade, Edinéia; Bento, Allisson; Campos, Maria M; Basso, Luiz A; Santos, Diógenes S

    2017-02-20

    In the present study, we evaluated the safety and the possible toxic effects of IQG-607 after acute and 90-day repeated administrations in rats. Single oral administration of IQG-607 (300 or 2000 mg/kg) on female rats did not result in any mortality. No gross lesions were observed in the animals at necropsy. Ninety-day administration test resulted in 20% of deaths, in both male and female rats administered with the highest dose of IQG-607, 300 mg/kg. Repeated administration of the IQG 607 (25, 100 and 300 mg/kg) did not result in any significant body mass alteration, or changes in food and water consumption. The most important clinical sign observed was salivation in both sexes. Importantly, long-term treatment with IQG-607 did not induce alterations in any hematological (for both sex) and serum biochemical (for female) parameters evaluated, even at the highest dose tested. Treatment of male rats with 100 or 300 mg/kg of IQG-607 decreased total cholesterol levels, while animals treated with 100 mg/kg also presented reduction on triglyceride levels. Of note, no treatment induced significant histopathological alterations in tissues of all organs and glands analyzed, even in that group that received the highest dose of IQG-607.

  10. Efficacy and safety of oral citicoline in acute ischemic stroke: drug surveillance study in 4,191 cases.

    PubMed

    Cho, H-J; Kim, Y J

    2009-04-01

    Citicoline is an essential precursor in the synthesis of phosphatidylcholine, a key cell membrane phospholipid, and is known to have neuroprotective effects in acute ischemic stroke. The aim of this study was to determine the efficacy and safety of oral citicoline in Korean patients with acute ischemic stroke. A drug surveillance study was carried out in 4,191 patients with a diagnosis of acute ischemic stroke. Oral citicoline (500-4000 mg/day) was administered within less than 24 h after acute ischemic stroke in 3,736 patients (early group) and later than 24 h after acute ischemic stroke in 455 patients (late group) for at least 6 weeks. For efficacy assessment, primary outcomes were patients' scores obtained with a short form of the National Institutes of Health Stroke Scale (s-NIHSS), a short form of the Barthel Index of activities of daily living (s-BI) and a modified Rankin Scale (mRS) at enrollment, after 6 weeks and at the end of therapy for those patients with extended treatment. All adverse reactions were monitored during the study period for safety assessment. All measured outcomes, including s-NIHSS, s-BI and mRS, were improved after 6 weeks of therapy (P < 0.05). Further improvement was observed in 125 patients who continued citicoline therapy for more than 12 weeks when compared with those who ended therapy at week 6. Improvements were more significant in the higher dose group (> or = 2000 mg/day) (P < 0.001). s-BI scores showed no differences between the early and late groups at the end of therapy. Citicoline safety was excellent; 37 side effects were observed in 31 patients (0.73%). The most frequent findings were nervous system-related symptoms (8 of 37, 21.62%), followed by gastrointestinal symptoms (5 of 37, 13.5%). Oral citicoline improved neurological, functional and global outcomes in patients with acute ischemic stroke without significant safety concerns.

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

    NASA Technical Reports Server (NTRS)

    Knight, John C.

    1993-01-01

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

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

    PubMed Central

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

    2016-01-01

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

  13. Use and Safety of Anthroposophic Medications for Acute Respiratory and Ear Infections: A Prospective Cohort Study

    PubMed Central

    Hamre, Harald J.; Glockmann, Anja; Fischer, Michael; Riley, David S.; Baars, Erik; Kiene, Helmut

    2007-01-01

    Objective Anthroposophic medications (AMED) are widely used, but safety data on AMED from large prospective studies are sparse. The objective of this analysis was to determine the frequency of adverse drug reactions (ADR) to AMED in outpatients using AMED for acute respiratory and ear infections. Methods A prospective four-week observational cohort study was conducted in 21 primary care practices in Europe and the U.S.A. The cohort comprised 715 consecutive outpatients aged ≥1 month, treated by anthroposophic physicians for acute otitis and respiratory infections. Physicians’ prescription data and patient reports of adverse events were analyzed. Main outcome measures were use of AMED and ADR to AMED. Results Two patients had confirmed ADR to AMED: 1) swelling and redness at the injection site after subcutaneous injections of Prunus spinosa 5%, 2) sleeplessness after intake of Pneumodoron® 2 liquid. These ADR lasted one and two days respectively; both subsided after dose reduction; none were unexpected; none were serious. The frequency of confirmed ADR to AMED was 0.61% (2/327) of all different AMED used, 0.28% (2/715) of patients, and 0.004% (3/73,443) of applications. Conclusion In this prospective study, anthroposophic medications used by primary care patients with acute respiratory or ear infections were well tolerated. PMID:21901075

  14. Safety and efficacy field study of artesunate for dogs with non-resectable tumours.

    PubMed

    Rutteman, Gerard R; Erich, Suzanne A; Mol, Jan A; Spee, Bart; Grinwis, Guy C M; Fleckenstein, Lawrence; London, Cheryl A; Efferth, Thomas

    2013-05-01

    The anti-malarial drug artesunate has shown anticancer activity in vitro and in preliminary animal experiments, but experience in patients with cancer is very limited. Pre-clinical studies in dogs indicated morbidity at high dosage levels. This study evaluated the effects of artesunate in canine cancer cell lines and in canine cancer patients. Four canine cell lines were tested in vitro for sensitivity towards artesunate and dihydroartemisinin (DHA; active metabolite of artesunate). The half-maximal inhibitory concentration (IC50) values for artesunate or DHA were 2-60 μM in three cell lines, while one cell line was much less sensitive to artesunate (IC50 337 μM) than to DHA (IC50 50 μM). A safety/efficacy field study with artesunate was conducted in 23 dogs with non-resectable tumours. Artesunate was administered for 7-385 days at a dosage of 651-1178 (median 922) mg/m(2). No neurological or cardiac toxicity was observed and seven dogs exhibited no adverse effects at all. Fever and haematological/gastrointestinal toxicity, mostly transient, occurred in 16 dogs. One dog died from pneumonia. Plasma artesunate and DHA levels fell below the limit of detection within 8-12 h after artesunate administration, while levels after two hours were close to 1 μM. Artesunate produced a long-lasting complete remission in one case of cancer and short-term stabilization of another seven cases.

  15. Safety assessment of vitacoxib: Acute and 90-day sub-chronic oral toxicity studies.

    PubMed

    Wang, Jianzhong; Sun, Feifei; Tang, Shusheng; Zhang, Suxia; Lv, Pengyue; Li, Jing; Cao, Xingyuan

    2017-02-24

    Vitacoxib, is a newly developed coxibs NSAID (selective inhibitors of cyclooxygenase-2). To date, no experimental data have been published concerning its safety for use as an additive in the human diet. In the present study, we assessed the acute and sub-chronic toxicity of vitacoxib administered by gavage. The acute toxicity tests in Sprague Dawley (SD) rats and ICR mice demonstrated that vitacoxib at a dose of 5000 mg/kg BW failed to alter any of the parameters studied. In the 90-day sub-chronic toxicity test, vitacoxib was administered to SD rats at the doses of 0 (control), 5, 10, 20, 30, and 60 mg/kg BW. The results demonstrated that there were no significant differences for most indexes of sub-chronic toxicity throughout the experiment at the dose of 5-20 mg/kg BW, indicating no apparent dose-dependent. However, there were significant histopathology changes in the liver and kidney, and alterations in some biochemical parameters in the 60 mg/kg BW group. Based on these findings, the gavage LD50 was determined to be > 5000 mg/kg in SD rats and ICR mice, and the 90-day gavage no-observed-adverse-effect level (NOAEL) of vitacoxib was considered to be 20 mg/kg BW under the present study conditions.

  16. A scan statistic for identifying optimal risk windows in vaccine safety studies using self-controlled case series design.

    PubMed

    Xu, Stanley; Hambidge, Simon J; McClure, David L; Daley, Matthew F; Glanz, Jason M

    2013-08-30

    In the examination of the association between vaccines and rare adverse events after vaccination in postlicensure observational studies, it is challenging to define appropriate risk windows because prelicensure RCTs provide little insight on the timing of specific adverse events. Past vaccine safety studies have often used prespecified risk windows based on prior publications, biological understanding of the vaccine, and expert opinion. Recently, a data-driven approach was developed to identify appropriate risk windows for vaccine safety studies that use the self-controlled case series design. This approach employs both the maximum incidence rate ratio and the linear relation between the estimated incidence rate ratio and the inverse of average person time at risk, given a specified risk window. In this paper, we present a scan statistic that can identify appropriate risk windows in vaccine safety studies using the self-controlled case series design while taking into account the dependence of time intervals within an individual and while adjusting for time-varying covariates such as age and seasonality. This approach uses the maximum likelihood ratio test based on fixed-effects models, which has been used for analyzing data from self-controlled case series design in addition to conditional Poisson models.

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

    PubMed

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

    2014-05-30

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

  18. Safety test and field study of an inactivated oil-adjuvanted H5N1 avian influenza vaccine.

    PubMed

    Imamura, Takashi; Sakamoto, Ryuichi; Sasaki, Takashi; Kokumai, Norihide; Ohgitani, Toshiaki; Sawata, Akira; Lin, Zhifeng; Sakaguchi, Masashi

    2010-11-01

    We previously reported the development of an inactivated oil-adjuvanted avian influenza vaccine using an apathogenic H5N1 strain of the same lineage as the Eurasian lineage viruses currently epidemic in Asia. In this study, we confirmed the safety and evaluated the efficacy of this vaccine in layer chicken farms by field trials. No problematic adverse reactions occurred in the safety test. In addition, no adverse effects were observed in the field trial, and the antibody titer exceeded a protective level (hemagglutination inhibition (HI) antibody titer of 16) at 3 weeks after a single injection. Based on the above findings, this vaccine was confirmed to be safe and induced a protective level of antibody titer with a single injection in the chickens at the farms.

  19. A 6-month large-scale study into the safety of tamsulosin

    PubMed Central

    Michel, M C; Bressel, H-U; Goepel, M; Rübben, H

    2001-01-01

    Aims Tamsulosin is an α1-adrenoceptor antagonist for the treatment of symptomatic benign prostatic hyperplasia with a tolerability similar to that of placebo in short-term, placebo-controlled studies with limited patient numbers. The present study was designed to test the safety of tamsulosin treatment in a large cohort of men during a prolonged period of time, particularly with regard to comedications. Methods A multicentre, open-label phase IIIb study with 1784 patients receiving 0.4 mg o.d. tamsulosin for 6 months was performed according to good clinical practice guidelines. The analysis was performed on an intention-to-treat basis and powered to detect adverse events (AE) occurring in 0.15% of patients with 95% confidence. Results During a total drug exposure time of 811 patient years, 386 AE were recorded in 253 patients (14.2%; 95% confidence intervals [CI] 12.0–15.2%). Twenty-nine patients suffered 44 serious AE including five fatal events (CI 0.12–0.73%) due to myocardial infarction (n = 3) and to pneumonia and a car accident (one each), but all deaths were judged to be unlikely to be related to study medication. The frequency of AE in patients without any comedication (n = 1095) was 13.0% (CI 11.3–14.9%). In a logistic regression analysis β-adrenoceptor blockers, converting enzyme inhibitors, antidiabetics and diuretics did not significantly affect the odds ratio for having AE. However, concomitant α-adrenoceptor antagonists (a protocol violation) and treatment with verapamil (which also has α-adrenoceptor antagonist activity) significantly enhanced the odds ratio for having AE to 3.87 (CI 1.52–9.85) and 3.17 (CI 1.52–6.58), respectively. Minor increases in the odds ratio, which did not reach statistical significance, were also observed for Ca2+ antagonists other than verapamil and for nitrates. Conclusions We conclude that tamsulosin has a good safety profile relative to AE rates in the placebo arms of previous studies on tamsulosin even in

  20. Safety of dobutamine-atropine stress echocardiography: A prospective experience of 4,033 consecutive studies.

    PubMed

    Mathias, W; Arruda, A; Santos, F C; Arruda, A L; Mattos, E; Osório, A; Campos, O; Gil, M; Andrade, J L; Carvalho, A C

    1999-10-01

    Dobutamine-atropine stress echocardiography (DASE) is an established method and has been shown to be accurate for the detection of coronary artery disease. Still, there are few large clinical studies that analyze the safety of DASE in general or the safety of performing it on an ambulatory basis. Most studies use a target heart rate as the primary end point regardless of whether asymptomatic ischemia occurs. Such studies have shown a serious cardiac event rate of approximately 0.3%. We prospectively studied 4,033 consecutive patients on an ambulatory basis and in the hospital with the use of DASE from July 1991 to December 1998. All tests were performed by an experienced physician, and all clinical and DASE data were stored in a large database organized at the beginning of the study. Dobutamine was infused in scalar doses of 5, 10, 20, 30, and 40 microg/kg per minute in 3-minute stages. Development of a new wall motion abnormality, achievement of 85% of target heart, and end of the DASE infusion protocol were used as an end point. If 85% of the target heart rate was not achieved, atropine was infused up to 1 mg in the absence of myocardial ischemia, which was used in 1,280 studies. There were 3,645 diagnostic tests, and 388 (10%) were found to be nondiagnostic. This result was due to poor image quality in 115 (3%), end of protocol in negative-submaximal examinations in 124 (3%), and limiting side effects in 149 (4%). Thirty-seven percent of the tests showed positive results for myocardial ischemia. Major test-related cardiac complications occurred in 10 (0.25%) patients and included 1 ventricular fibrillation, 1 case of myocardial infarction, and 8 cases of sustained ventricular tachycardia. Atropine poisoning was observed in 5 (0.12%) patients. No deaths occurred as a direct or indirect consequence of DASE. We conclude that dobutamine-atropine stress echocardiography is a reasonably safe method for detection of coronary artery disease in the hospital or in an

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

    PubMed Central

    Mascherek, Anna C

    2016-01-01

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

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

    ERIC Educational Resources Information Center

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

    2008-01-01

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

  3. Monitoring safety in a phase III real‐world effectiveness trial: use of novel methodology in the Salford Lung Study

    PubMed Central

    Harvey, Catherine; Brewster, Jill; Bakerly, Nawar Diar; Elkhenini, Hanaa F.; Stanciu, Roxana; Williams, Claire; Brereton, Jacqui; New, John P.; McCrae, John; McCorkindale, Sheila; Leather, David

    2016-01-01

    Abstract Background The Salford Lung Study (SLS) programme, encompassing two phase III pragmatic randomised controlled trials, was designed to generate evidence on the effectiveness of a once‐daily treatment for asthma and chronic obstructive pulmonary disease in routine primary care using electronic health records. Objective The objective of this study was to describe and discuss the safety monitoring methodology and the challenges associated with ensuring patient safety in the SLS. Refinements to safety monitoring processes and infrastructure are also discussed. The study results are outside the remit of this paper. The results of the COPD study were published recently and a more in‐depth exploration of the safety results will be the subject of future publications. Achievements The SLS used a linked database system to capture relevant data from primary care practices in Salford and South Manchester, two university hospitals and other national databases. Patient data were collated and analysed to create daily summaries that were used to alert a specialist safety team to potential safety events. Clinical research teams at participating general practitioner sites and pharmacies also captured safety events during routine consultations. Confidence in the safety monitoring processes over time allowed the methodology to be refined and streamlined without compromising patient safety or the timely collection of data. The information technology infrastructure also allowed additional details of safety information to be collected. Conclusion Integration of multiple data sources in the SLS may provide more comprehensive safety information than usually collected in standard randomised controlled trials. Application of the principles of safety monitoring methodology from the SLS could facilitate safety monitoring processes for future pragmatic randomised controlled trials and yield important complementary safety and effectiveness data. © 2016 The Authors

  4. Observation

    ERIC Educational Resources Information Center

    Helfrich, Shannon

    2016-01-01

    Helfrich addresses two perspectives from which to think about observation in the classroom: that of the teacher observing her classroom, her group, and its needs, and that of the outside observer coming into the classroom. Offering advice from her own experience, she encourages and defends both. Do not be afraid of the disruption of outside…

  5. Observations

    ERIC Educational Resources Information Center

    Joosten, Albert Max

    2016-01-01

    Joosten begins his article by telling us that love and knowledge together are the foundation for our work with children. This combination is at the heart of our observation. With this as the foundation, he goes on to offer practical advice to aid our practice of observation. He offers a "List of Objects of Observation" to help guide our…

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

    ERIC Educational Resources Information Center

    Centers for Disease Control and Prevention, 2007

    2007-01-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

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

    2014-01-01

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

  9. Screening stress factors survey in an institute of advanced studies: health and safety integrated plans.

    PubMed

    Fonseca, C S; Gomes, C N; Barros, F S

    2012-01-01

    The current paper presents the study of organizational stressors survey carried out in a military institute, responsible for researches of high demand on aerospace technology. The study considered the theoretical framework of Organizational Ergonomics, combined with the technical guidelines of Psychology applied to Work Safety. The participatory approach was used on daily work assessment and decision making, aiming the adoption of corrective and preventive measures, considering possible distortions and imbalances between prescribed and actual activities. Thus, it was sought to engage and encourage the participation of the Institute's workers in the reflection/creation of better solutions to daily problems and to achieve productivity, without prejudice in the occupational health and safety.

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

    NASA Technical Reports Server (NTRS)

    Aragon, Cecilia R.; Hearst, Marti

    2005-01-01

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

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

    PubMed

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

    2015-01-01

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

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

    PubMed

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

    2007-01-01

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

  13. Designing premarket observational comparative studies using existing data as controls: challenges and opportunities.

    PubMed

    Yue, Lilly Q; Lu, Nelson; Xu, Yunling

    2014-01-01

    Due to the special nature of medical device clinical studies, observational (nonrandomized) comparative studies play important roles in the premarket safety/effectiveness evaluation of medical devices. While historical data collected in earlier investigational device exemption studies of a previously approved medical device have been used to form control groups in comparative studies, high-quality registry data are emerging to provide opportunities for the premarket evaluation of new devices. However, in such studies, various biases could be introduced in every stage and aspect of study and may compromise the objectivity of study design and validity of study results. In this article, challenges and opportunities in the design of such studies using propensity score methodology are discussed from regulatory perspectives.

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

    PubMed Central

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

    2014-01-01

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

  15. Testing VHF/GPS collar design and safety in the study of free-roaming horses.

    PubMed

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

    2014-01-01

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

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

    NASA Technical Reports Server (NTRS)

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

    1970-01-01

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

  17. Case Study Observational Research: A Framework for Conducting Case Study Research Where Observation Data Are the Focus.

    PubMed

    Morgan, Sonya J; Pullon, Susan R H; Macdonald, Lindsay M; McKinlay, Eileen M; Gray, Ben V

    2016-05-22

    Case study research is a comprehensive method that incorporates multiple sources of data to provide detailed accounts of complex research phenomena in real-life contexts. However, current models of case study research do not particularly distinguish the unique contribution observation data can make. Observation methods have the potential to reach beyond other methods that rely largely or solely on self-report. This article describes the distinctive characteristics of case study observational research, a modified form of Yin's 2014 model of case study research the authors used in a study exploring interprofessional collaboration in primary care. In this approach, observation data are positioned as the central component of the research design. Case study observational research offers a promising approach for researchers in a wide range of health care settings seeking more complete understandings of complex topics, where contextual influences are of primary concern. Future research is needed to refine and evaluate the approach.

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

    PubMed

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

    2014-07-01

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

  19. Cause versus association in observational studies in psychopharmacology.

    PubMed

    Andrade, Chittaranjan

    2014-08-01

    Hypotheses may be generated (and conclusions drawn) from observational studies in areas where information from randomized controlled trials (RCTs) is unavailable. However, observational studies can only establish that significant associations exist between predictor and outcome variables. Observational studies cannot establish that the associations identified represent cause-and-effect relationships. This article discusses examples of associations that were identified in observational studies and that were subsequently refuted in RCTs. Examples are also provided of associations that have yet to be confirmed or refuted but that are nevertheless influential in psychopharmacologic practice. Explanations are offered about how confounding might explain significant relationships between variables that are not related by cause and effect. As a conclusion of this exercise, clinicians are cautioned against placing too much reliance on the findings of observational research.

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

    NASA Astrophysics Data System (ADS)

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

    2014-11-01

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

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

    PubMed Central

    2014-01-01

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

  2. 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%…

  3. Observation

    ERIC Educational Resources Information Center

    Kripalani, Lakshmi A.

    2016-01-01

    The adult who is inexperienced in the art of observation may, even with the best intentions, react to a child's behavior in a way that hinders instead of helping the child's development. Kripalani outlines the need for training and practice in observation in order to "understand the needs of the children and...to understand how to remove…

  4. Safety study of 50 Hz repetitive transcranial magnetic stimulation in patients with Parkinson’s disease

    PubMed Central

    Benninger, David H.; Lomarev, Mikhail; Wassermann, Eric; Lopez, Grisel; Houdayer, Elise; Fasano, Rebecca E.; Dang, Nguyet; Hallett, Mark

    2009-01-01

    Objective Repetitive transcranial magnetic stimulation (rTMS) has shown promising results in treating Parkinson’s disease (PD), but the best values for rTMS parameters are not established. 50 Hz rTMS may be superior to ≤ 25 Hz rTMS investigated so far. The objective of this study was to determine if 50 Hz rTMS could be delivered safely in PD patients since current safety limits are exceeded. Methods 50 Hz rTMS was applied with a circular coil on the primary motor cortex (M1). Stimulation intensity was first tested at 60% rest motor threshold [RMT] and 0.5 sec train duration and then increased in 0.5 sec steps to 2 sec, and by 10% steps to 90% RMT. Multi-channel electromyography (EMG) was recorded to control for signs of increasing time-locked EMG activity including correlates of the spread of excitation and after-discharges, or an increase of M1 excitability. Pre- and post-50 Hz rTMS assessments included EEG, Unified Parkinson Disease Rating Scale (UPDRS), Grooved Pegboard Test, Serial Reaction Time Task (SRTT), Folstein Mini-Mental Status Examination (MMSE) and Verbal Fluency to control for motor and cognitive side effects. Results Ten PD patients were investigated. Multi-channel EMG showed no signs of increased time-locked EMG activity including correlates of the spread of excitation and after-discharges, or increased M1 excitability in 9 patients. A PD patient with bi-temporal spikes in the pre-testing EEG had clinical and EMG correlates of spread of excitation at 90% RMT, but no seizure activity. Pre- and post-50 Hz assessment showed no changes. No adverse events were observed. 50 Hz rTMS was well tolerated except by one patient who wished to terminate the study due to facial muscle stimulation. Conclusion 50 Hz rTMS at an intensity of 90% RMT for 2 sec appears safe in patients with PD, but caution should be taken for patients with paroxysmal EEG activity. For this reason, comprehensive screening should include EEG before higher-frequency rTMS is applied

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

    NASA Technical Reports Server (NTRS)

    Karns, James

    1993-01-01

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

  6. Efficacy and safety of piascledine 300 versus chondroitin sulfate in a 6 months treatment plus 2 months observation in patients with osteoarthritis of the knee.

    PubMed

    Pavelka, Karel; Coste, Philippe; Géher, Pál; Krejci, Gerhard

    2010-06-01

    To investigate that a 6-month treatment with avocado soybean unsaponifiable (Piascledine 300 mg) once daily is as effective as with chondroitin sulfate 400 mg three times daily in femorotibial gonarthrosis, and also the carry-over effect for two more months is comparable. Patients were randomized (1:1) to the treatment groups. They received for 6 months 3 capsules chondroitin sulfate per day or one capsule of avocado soybean unsaponifiable (ASU) in a double-dummy technique. A 2-month post-treatment period followed to determine the carry-over effect. Primary efficacy criterion was the change of the WOMAC-index from study begin to end of treatment. Secondary criteria were the changes in Lequesne-index, pain on active movement and at rest, global assessment of efficacy. Three hundred sixty-four patients have been taken up into the trial. Three hundred sixty one patients were eligible for evaluation. One hundred eighty three received ASU 300 mg once daily, one hundred seventy eight chondroitin sulfate three times daily. The WOMAC-index decreased in both groups for approx. 50% to the end of therapy. During the post-treatment observation there was a further slight improvement. There was no statistical significant difference between the treatment groups during the entire observation. All other observed parameters showed the same pattern. The daily intake of rescue medication was reduced continuously. Overall efficacy has been rated excellent and good in more than 80% of the patients in both groups. Both drugs were safe and well tolerated. The first direct comparison between avocado soybean unsaponifiable 300 mg once daily and chondroitin sulfate three times daily reveiled no difference in efficacy or safety aspects between 1 capsule ASU 300 mg per day and 3 capsules chondroitin sulfate per day. It can be assumed that the once daily intake of ASU will lead to a better compliance in routine therapy.

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

    PubMed Central

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

    2015-01-01

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

  8. Safety profiling of pioglitazone and telmisartan combination by sub-chronic toxicity study in rat.

    PubMed

    Sengupta, Pinaki; Das, Arindam; Ibrahim, Fuzianna; Mandal, Uttam Kumar; Chatterjee, Bappaditya; Mahmood, Syed; Das, Sreemoy Kanti; Kifayatullah, Muhammad

    2016-11-01

    It has been reported that the major cause of mortality in diabetes is cardiovascular diseases and contribution of hypertension is significant in this context. Pioglitazone, a thiazolidinedione class of therapeutic agent is used to treat type 2 diabetes mellitus. Telmisartan, an angiotensin receptor blocker antihypertensive has been reported to have beneficial effect if co-administered with pioglitazone for the management of diabetes complications. The present research work aims to evaluate the safety/toxicity profile of this combination in rat model. The investigation was carried out after co-administering the drugs to the rats for 28 days at three dose levels of 50, 100 and 150 mg/kg covering low to high dose ranges. Various hematological and biochemical parameters were studied in addition to the histopathology of the major organs in order to evaluate the toxicity profile of the combination. Absence of mortality and histopathological changes as well as unaltered hematological and biochemical parameters was observed. This preliminary investigation concludes that the combination of pioglitazone and telmisartan can primarily be stated as safe in animals, even at the dose level which is several folds higher than the intended human dose. Thus, this combination can be explored in future to develop a rational therapy regimen to treat hypertensive diabetic patients.

  9. Feasibility and Safety of Pressurized Intraperitoneal Aerosol Chemotherapy for Peritoneal Carcinomatosis: A Retrospective Cohort Study

    PubMed Central

    Grass, Fabian; Wolfer, Anita; Mathevet, Patrice; Hahnloser, Dieter

    2017-01-01

    Background. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) has been introduced as a novel repeatable treatment for peritoneal carcinomatosis. The available evidence from the pioneer center suggests good tolerance and high response rates, but independent confirmation is needed. A single-center cohort was analyzed one year after implementation for feasibility and safety. Methods. PIPAC was started in January 2015, and every patient was entered into a prospective database. This retrospective analysis included all consecutive patients operated until April 2016 with emphasis on surgical feasibility and early postoperative outcomes. Results. Forty-two patients (M : F = 8 : 34, median age 66 (59–73) years) with 91 PIPAC procedures in total (4×: 1,  3×: 17,  2×: 12, and  1×: 12) were analyzed. Abdominal accessibility rate was 95% (42/44); laparoscopic access was not feasible in 2 patients with previous HIPEC. Median initial peritoneal carcinomatosis index (PCI) was 10 (IQR 5–17). Median operation time was 94 min (89–108) with no learning curve observed. One PIPAC application was postponed due to intraoperative intestinal lesion. Overall morbidity was 9% with 7 minor complications (Clavien I-II) and one PIPAC-unrelated postoperative mortality. Median postoperative hospital stay was 3 days (2-3). Conclusion. Repetitive PIPAC is feasible in most patients with refractory carcinomatosis of various origins. Intraoperative complications and postoperative morbidity rates were low. This encourages prospective studies assessing oncological efficacy. PMID:28331493

  10. 40 CFR 725.92 - Data from health and safety studies of microorganisms.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... microorganisms. 725.92 Section 725.92 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS Confidentiality and Public Access to Information § 725.92 Data from health and safety studies of microorganisms....

  11. 40 CFR 725.92 - Data from health and safety studies of microorganisms.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... microorganisms. 725.92 Section 725.92 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS Confidentiality and Public Access to Information § 725.92 Data from health and safety studies of microorganisms....

  12. 40 CFR 725.92 - Data from health and safety studies of microorganisms.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... microorganisms. 725.92 Section 725.92 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS Confidentiality and Public Access to Information § 725.92 Data from health and safety studies of microorganisms....

  13. 40 CFR 725.92 - Data from health and safety studies of microorganisms.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... microorganisms. 725.92 Section 725.92 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS Confidentiality and Public Access to Information § 725.92 Data from health and safety studies of microorganisms....

  14. 40 CFR 725.92 - Data from health and safety studies of microorganisms.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... microorganisms. 725.92 Section 725.92 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS Confidentiality and Public Access to Information § 725.92 Data from health and safety studies of microorganisms....

  15. Policy Research and Child Passenger Safety Legislation: A Case Study and Experimental Evaluation.

    ERIC Educational Resources Information Center

    Fawcett, Stephen B.; And Others

    1987-01-01

    Research findings have been used by states to formulate legislation to increase child passenger safety. Case studies from Kansas and Illinois are presented. The process is most successful when researchers are sensitive to the policy making process. The implications for the use of psychological research findings are discussed. (VM)

  16. Safety and efficacy of the cathepsin K inhibitor ONO-5334 in postmenopausal osteoporosis: the OCEAN study.

    PubMed

    Eastell, Richard; Nagase, Shinichi; Ohyama, Michiyo; Small, Maria; Sawyer, James; Boonen, Steven; Spector, Tim; Kuwayama, Tomohiro; Deacon, Steve

    2011-06-01

    Osteoporosis occurs when there is an imbalance between resorption and formation of bone, with resorption predominating. Inhibitors of cathepsin K may rebalance this condition. This is the first efficacy study of a new cathepsin K inhibitor, ONO-5334. The objective of the study was to investigate the efficacy and safety of ONO-5334 in postmenopausal osteoporosis. This was a 12-month, randomized, double-blind, placebo- and active-controlled parallel-group study conducted in 13 centers in 6 European countries. Subjects included 285 postmenopausal women aged 55 to 75 years with osteoporosis. Subjects were randomized into one of five treatment arms: placebo; 50 mg twice daily, 100 mg once daily, or 300 mg once daily of ONO-5334; or alendronate 70 mg once weekly. Lumbar spine, total hip, and femoral neck BMD values were obtained along with biochemical markers of bone turnover and standard safety assessments. All ONO-5334 doses and alendronate showed a significant increase in BMD for lumbar spine, total hip (except 100 mg once daily), and femoral neck BMD. There was little or no suppression of ONO-5334 on bone-formation markers compared with alendronate, although the suppressive effects on bone-resorption markers were similar. There were no clinically relevant safety concerns. With a significant increase in BMD, ONO-5334 also demonstrated a new mode of action as a potential agent for treating osteoporosis. Further clinical studies are warranted to investigate long-term efficacy as well as safety of ONO-5334.

  17. A Study of Truck Drivers and Their Job Performance Regarding Highway Safety

    ERIC Educational Resources Information Center

    Nafukho, Fredrick M.; Hinton, Barbara E.; Graham, Carroll M.

    2007-01-01

    Limited research has addressed the issue of truck drivers and their performance regarding highway safety in terms of reduced number of crashes per driver. The primary purpose of this study was to determine how tractor trailer truck drivers' job performance could be improved while at the same time ensuring increased revenue for the transportation…

  18. Perceptions of Psychological and Physical Safety Environments of Information Technology Employees: A Phenomenological Study

    ERIC Educational Resources Information Center

    Payne, Sheila C.

    2012-01-01

    A qualitative phenomenological study was conducted to gain a deeper understanding of psychological and safety environments of an oil and gas multinational enterprise. Twenty information technology professionals were interviewed to explore their feelings, perceptions, beliefs, and values of the phenomenon. The interviews elicited data about facets…

  19. Development and Evaluation of a Multi-Institutional Case Studies-Based Course in Food Safety

    ERIC Educational Resources Information Center

    Pleitner, Aaron M.; Chapin, Travis K.; Hammons, Susan R.; Stelten, Anna Van; Nightingale, Kendra K.; Wiedmann, Martin; Johnston, Lynette M.; Oliver, Haley F.

    2015-01-01

    Developing novel, engaging courses in food safety is necessary to train professionals in this discipline. Courses that are interactive and case-based encourage development of critical thinking skills necessary for identifying and preventing foodborne disease outbreaks. The purpose of this study was to assess the efficacy of a case study…

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

    ERIC Educational Resources Information Center

    Tapp, Jon; Wehby, Joseph

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

  1. Empirical Performance of Covariates in Education Observational Studies

    ERIC Educational Resources Information Center

    Wong, Vivian C.; Valentine, Jeffrey C.; Miller-Bains, Kate

    2017-01-01

    This article summarizes results from 12 empirical evaluations of observational methods in education contexts. We look at the performance of three common covariate-types in observational studies where the outcome is a standardized reading or math test. They are: pretest measures, local geographic matching, and rich covariate sets with a strong…

  2. An Observational Study of Skilled Memory in Waitresses.

    ERIC Educational Resources Information Center

    Stevens, Joy

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

  3. Impact of the Genetics and Source of Preclinical Safety Animal Models on Study Design, Results, and Interpretation.

    PubMed

    Colman, Karyn

    2017-01-01

    It has been long established that not only the species but also the strain and supplier of rodents used in preclinical safety studies can have a significant impact on the outcome of studies due to variability in their genetic background and thus spontaneous pathologic findings. In addition, local husbandry, housing, and other environmental conditions may have effects on the development and expression of comorbidities, particularly in longer-term or chronic studies. More recently, similar effects related to the source, including genetic and environmental variability, have been recognized in cynomolgus macaques ( Macaca fascicularis). The increased use of cynomolgus macaques from various sources of captive-bred animals (including nonnative, U.S./European Union-based breeding facilities or colonies) can affect study design and study results and outcome. It is important to acknowledge and understand the impact of this variability on the results and interpretation of research studies. This review includes recent examples where variability of preclinical animal models (rats and monkeys) affected the postmortem observations highlighting its relevance to study design or interpretation in safety studies.

  4. Effectiveness, safety, durability and immune recovery in a retrospective, multicentre, observational cohort of ART-experienced, HIV-1-infected patients receiving maraviroc.

    PubMed

    Dentone, C; Sterrantino, G; Signori, A; Cenderello, G; Guerra, M; De Leo, P; Bartolacci, V; Mantia, E; Orofino, G; Giacomini, M; Bruzzone, B; Francisci, D; Di Biagio, A

    2017-01-01

    The aim of this retrospective, multicentre, observational study was to assess the durability, safety, immune recovery and effectiveness on viral suppression of antiretroviral therapy (ART) in a maraviroc (MVC)-based cohort. We collected clinical, demographical, immunological and virological parameters of adult HIV patients who were infected by CCR5-tropic virus and started an ART regimen containing MVC from 2005 to 2012. We created a longitudinal mixed model to assess the change over time of data. We enrolled 126 drug-experienced patients; the median duration of MVC treatment was 25 months. The probability of stopping ART at one year was 13.3%, and at three years was 27.3%. Statistically significant changes were observed for CD4+ cell count increase ( p < 0.001), HIV-RNA decrease ( p < 0.001) and total cholesterol decrease ( p = 0.005). Ninety-four patients (79.7%) had CD4 ≥ 200 cells/mm(3) at baseline while nine of them reached this threshold at nine months (7.6%), 17 (13%) after nine months and six (5%) remained below 200 cells/mm(3) at the end of the study. Overall, 114 patients (90.5%) achieved an HIV-RNA ≤ 50 cp/ml. A majority of patients maintained CD4 cell counts of ≥ 200 cells/mm(3) and achieved an undetectable HIV viral load within three months. MVC-containing regimens are safe and appear to be a feasible therapeutic option for ART.

  5. Safety and effectiveness of teriparatide vs alendronate in postmenopausal osteoporosis: a prospective non randomized clinical study.

    PubMed

    Caggiari, Gianfilippo; Leali, Paolo Tranquilli; Mosele, Giulia Raffaella; Puddu, Leonardo; Badessi, Francesca; Doria, Carlo

    2016-01-01

    In this work we study the safety and effectiveness of teriparatide and alendronate in patients with postmenopausal osteoporosis at high risk of fracture; it was a double-blinded and it was done by examining the comparisons between teriparatide 20 μg/day and alendronate 10 mg/day. Safety and effectiveness analyses were based on data from 355 woman with a mean age of 68 years. Two groups (A and B) with T-score ≤-2.5 at bone mineral density were analyzed and 3 or more vertebral fractures on radiograph. Group A: was treated with teriparatide 20 μg/day and composed from 182 women, in post-menopausal age, without a history of cancer. Group B: was treated with alendronate 10 mg/day composed from 173 women, postmenopausal age, with previous history of cancer (non-active during the study). Clinical evaluations were on bone turnover markers (alkaline phosphatase, procollagene type 1 N-terminal propeptide, and N-telopeptide cross-links), dual-energy X-ray absorptiometry and health-related quality of life (HrQoL). Safety was assessed by reporting of adverse drug reactions (ADRs). The results of this study imply that teriparatide comparated with alendronate has a favorable safety profile and is effective in the treatment of patients with osteoporosis at high risk of fracture.

  6. Safety and effectiveness of teriparatide vs alendronate in postmenopausal osteoporosis: a prospective non randomized clinical study

    PubMed Central

    Caggiari, Gianfilippo; Leali, Paolo Tranquilli; Mosele, Giulia Raffaella; Puddu, Leonardo; Badessi, Francesca; Doria, Carlo

    2016-01-01

    Summary In this work we study the safety and effectiveness of teriparatide and alendronate in patients with postmenopausal osteoporosis at high risk of fracture; it was a double-blinded and it was done by examining the comparisons between teriparatide 20 μg/day and alendronate 10 mg/day. Safety and effectiveness analyses were based on data from 355 woman with a mean age of 68 years. Two groups (A and B) with T-score ≤–2.5 at bone mineral density were analyzed and 3 or more vertebral fractures on radiograph. Group A: was treated with teriparatide 20 μg/day and composed from 182 women, in post-menopausal age, without a history of cancer. Group B: was treated with alendronate 10 mg/day composed from 173 women, postmenopausal age, with previous history of cancer (non-active during the study). Clinical evaluations were on bone turnover markers (alkaline phosphatase, procollagene type 1 N-terminal propeptide, and N-telopeptide cross-links), dual-energy X-ray absorptiometry and health-related quality of life (HrQoL). Safety was assessed by reporting of adverse drug reactions (ADRs). The results of this study imply that teriparatide comparated with alendronate has a favorable safety profile and is effective in the treatment of patients with osteoporosis at high risk of fracture. PMID:28228782

  7. Improving safety climate through a communication and recognition program for construction: a mixed-methods study

    PubMed Central

    Sparer, Emily H; Catalano, Paul J; Herrick, Robert F; Dennerlein, Jack T

    2016-01-01

    Objectives This study aimed to evaluate the efficacy of a safety communication and recognition program (B-SAFE), designed to encourage improvement of physical working conditions and hazard reduction in construction. Methods A matched pair cluster randomized controlled trial was conducted on eight worksites (four received the B-SAFE intervention, four served as control sites) for approximately five months per site. Pre- and post-exposure worker surveys were collected at all sites (N=615, pre-exposure response rate of 74%, post-exposure response rate of 88%). Multi-level mixed-effect regression models evaluated the effect of B-SAFE on safety climate as assessed from surveys. Focus groups (N=6–8 workers/site) were conducted following data collection. Transcripts were coded and analyzed for thematic content using Atlas.ti (version 6). Results The mean safety climate score at intervention sites, as measured on a 0–50 point scale, increased 0.5 points (1%) between pre- and post-B-SAFE exposure, compared to control sites that decreased 0.8 points (1.6%). The intervention effect size was 1.64 (3.28%) (P-value=0.01) when adjusted for month the worker started on-site, total length of time on-site, as well as individual characteristics (trade, title, age, and race/ethnicity). At intervention sites, workers noted increased levels of safety awareness, communication, and teamwork compared to control sites. Conclusions B-SAFE led to many positive changes, including an improvement in safety climate, awareness, teambuilding, and communication. B-SAFE was a simple intervention that engaged workers through effective communication infrastructures and had a significant, positive effect on worksite safety. PMID:27158914

  8. Safety of Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12-supplemented yogurt in healthy adults on antibiotics: a phase I safety study

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Probiotics are live microorganisms that, when administered in sufficient doses, provide health benefits on the host. The United States Food and Drug Administration (FDA) requires phase I safety studies for probiotics when the intended use of the product is as a drug. The purpose of the study was to ...

  9. Post-marketing surveillance study of the efficacy and safety of vardenafil among patients with erectile dysfunction in primary care.

    PubMed

    Kim, C M; Kim, Y S; Sunwoo, S; Cho, B; Rho, M; Yang, Y J; Kim, C H; Shin, H C; Lee, S Y; Kim, D H

    2007-01-01

    To evaluate the safety and efficacy of vardenafil in primary care, we undertook a post-marketing surveillance study in 384 men with erectile dysfunction (ED), enrolled by 22 family physicians in Korea, from July 2004 to August 2005. Of the 384 patients enrolled, 343 (89.3%) returned for efficacy assessment and safety evaluation. Among the latter, 279 patients (81.3%) reported that their erectile function improved, 292 (92.1%) showed enhanced IIEF (International Index of Erectile Function)-5 scores and 265 (77.9%) responded that they were 'very satisfied' or 'satisfied' with vardenafil treatment. The most frequent reason for patient satisfaction with vardenafil was erectile potency (62.4%), followed by safety (42.4%), rapid onset (35.3%), adequate duration of efficacy (28.5%) and easy administration (25.9%). A total of 23 adverse events were observed in 18 patients, with the most frequent being hot flushes (3.2%), followed by headache (1.2%), nasal congestion (0.6%), color vision disturbance (0.3%), dizziness (0.3%), dry mouth (0.3%), dyspepsia (0.3%), nausea (0.3%) and diarrhea (0.3%). Only one patient discontinued vardenafil as a direct result of an adverse event. These results suggest that vardenafil prescribed by primary care physicians improved erectile function and was well tolerated by patients with ED.

  10. Recommendations for the evaluation of pathology data in nonclinical safety biomarker qualification studies.

    PubMed

    Burkhardt, John E; Pandher, Karamjeet; Solter, Phillip F; Troth, Sean P; Boyce, Rogely Waite; Zabka, Tanja S; Ennulat, Daniela

    2011-12-01

    A set of best practices for the conduct of histopathology evaluation in nonclinical safety studies was endorsed by the Society of Toxicologic Pathology (STP) in 2004. These best practices indicate that the study pathologist should have knowledge of the treatment group and access to all available study-related data for the animal from which the tissue was obtained. A new set of best practices for the conduct of histopathology review for safety biomarker qualification for nonclinical studies has been endorsed by the STP and is summarized in this document. These best practices are generally similar to those for nonclinical safety studies, specifically that the pathologist be "unblinded" or have access to study data. Although histopathology evaluation in biomarker qualification studies must be performed without knowledge of novel biomarker data, the study pathologist(s) should be involved in the attendant meta-analyses of these data. Blinded evaluation is an experimental tool in biomarker qualification studies that is appropriate only when well-defined criteria for specific histopathologic findings are identified prior to blinded review. Additionally, this paper also considers the management of bias, the use of a tiered evaluation approach, the importance of using qualified pathologists and standard reporting, and the management of spontaneous findings.

  11. A literature review of safety culture.

    SciTech Connect

    Cole, Kerstan Suzanne; Stevens-Adams, Susan Marie; Wenner, Caren A.

    2013-03-01

    Workplace safety has been historically neglected by organizations in order to enhance profitability. Over the past 30 years, safety concerns and attention to safety have increased due to a series of disastrous events occurring across many different industries (e.g., Chernobyl, Upper Big-Branch Mine, Davis-Besse etc.). Many organizations have focused on promoting a healthy safety culture as a way to understand past incidents, and to prevent future disasters. There is an extensive academic literature devoted to safety culture, and the Department of Energy has also published a significant number of documents related to safety culture. The purpose of the current endeavor was to conduct a review of the safety culture literature in order to understand definitions, methodologies, models, and successful interventions for improving safety culture. After reviewing the literature, we observed four emerging themes. First, it was apparent that although safety culture is a valuable construct, it has some inherent weaknesses. For example, there is no common definition of safety culture and no standard way for assessing the construct. Second, it is apparent that researchers know how to measure particular components of safety culture, with specific focus on individual and organizational factors. Such existing methodologies can be leveraged for future assessments. Third, based on the published literature, the relationship between safety culture and performance is tenuous at best. There are few empirical studies that examine the relationship between safety culture and safety performance metrics. Further, most of these studies do not include a description of the implementation of interventions to improve safety culture, or do not measure the effect of these interventions on safety culture or performance. Fourth, safety culture is best viewed as a dynamic, multi-faceted overall system composed of individual, engineered and organizational models. By addressing all three components of

  12. Medication reconciliation as a medication safety initiative in Ethiopia: a study protocol

    PubMed Central

    Mekonnen, Alemayehu B; McLachlan, Andrew J; Brien, Jo-anne E; Mekonnen, Desalew; Abay, Zenahebezu

    2016-01-01

    Introduction Medication related adverse events are common, particularly during transitions of care, and have a significant impact on patient outcomes and healthcare costs. Medication reconciliation (MedRec) is an important initiative to achieve the Quality Use of Medicines, and has been adopted as a standard practice in many developed countries. However, the impact of this strategy is rarely described in Ethiopia. The aims of this study are to explore patient safety culture, and to develop, implement and evaluate a theory informed MedRec intervention, with the aim of minimising the incidence of medication errors during hospital admission. Methods and analyses The study will be conducted in a resource limited setting. There are three phases to this project. The first phase is a mixed methods study of healthcare professionals' perspectives of patient safety culture and patients' experiences of medication related adverse events. In this phase, the Hospital Survey on Patient Safety Culture will be used along with semi-structured indepth interviews to investigate patient safety culture and experiences of medication related adverse events. The second phase will use a semi-structured interview guide, designed according to the 12 domains of the Theoretical Domains Framework, to explore the barriers and facilitators to medication safety activities delivered by hospital pharmacists. The third phase will be a single centre, before and after study, that will evaluate the impact of pharmacist conducted admission MedRec in an emergency department (ED). The main outcome measure is the incidence and potential clinical severity of medication errors. We will then analyse the differences in the incidence and severity of medication errors before and after initiation of an ED pharmacy service. PMID:27884844

  13. Safety evaluation of ABELCET, an amphotericin B lipid complex (ABLC): toxicity studies in rats.

    PubMed

    Zhang, Zhihua; Diener, Robert M; Lipman, Jack M

    2006-01-01

    ABELCET (ABLC) is a widely used amphotericin B lipid complex formulation that is approved for use in the treatment of invasive fungal infections in patients who are refractory or intolerant of conventional amphotericin B (AmB). The safety profile of ABLC has been characterized in two acute and two repeat-dose toxicity studies in rats. The acute toxicity studies indicated that single intravenous doses of ABLC are at least 20 times less toxic than conventional amphotericin B doses without the lipid formulation, Fungizone. Intravenous doses of 0, 1, 3, or 10 mg/kg/day to groups of rats (10 to 15 rats/sex/group) for 31 days elicited no mortality or overt clinical signs of toxicity, whereas alternate intravenous/intraperitoneal doses (three each per week) for 6 months, produced one death in the control group, one in the intermediate-dose group, and two in the high-dose group. Clinical signs (predominantly piloerection and hunched posture at 10 mg/kg/day) were attributed to granulomatous inflammatory lesions in the abdominal wall, mesentery, and omentum, which were produced by the intraperitoneal injections of ABLC. Feed consumption and body weight gains decreased in high-dose male rats in the one-month study and were significantly lower in male rats at 3 and 10 mg/kg/day in the 6-month study. In contrast, water consumption increased in male and female rats in both studies. Trends of minimal to moderate, dose-related increases in relative kidney, liver and spleen weights, and histological evidence of hypertrophy and hyperplasia of reticuloendothelial cells in the liver and spleen and mild, dose-related impairment of renal function occurred in both the 1- and 6-month studies. Examination of high-dose rats following a recovery period of 28 days after completion of 31 days of dosing suggested that treatment-related changes were reversible. The observed changes for ABLC are similar to those for other amphotericin B lipid formulations, such as AmBisome (LAmB), except for the

  14. A safety study of a novel photosensitizer, sinoporphyrin sodium, for photodynamic therapy in Beagle dogs.

    PubMed

    Lin, Ni; Li, Chao; Wang, Zhonghua; Zhang, Jingxuan; Ye, Xiangfeng; Gao, Wenjing; Wang, Aiping; Jin, Hongtao; Wei, Jinfeng

    2015-04-01

    Sinoporphyrin sodium (DVDMS) is a novel hematoporphyrin-like photosensitizer developed for photodynamic therapy (PDT), an effective therapeutic modality for tumor treatment; however, the safety of photosensitizer-based PDT is always of great concern. The purpose of the current study was to investigate the potential repeated-dose toxicity and describe the toxicokinetic process of DVDMS-based PDT in Beagle dogs. The dogs were randomly allocated to six groups, and then were administrated a DVDMS preparation intravenously at dose levels of 0, 1, 3, 9, 1 and 9 mg per kg body weight, respectively; then, the latter two groups were illuminated 24 h later with a 630 nm laser for 10 min, once every seven days for 5 weeks. During the study period, clinical signs, mortality, body weight, food consumption, body temperature, ophthalmoscopy, hematology, serum biochemistry, urinalysis, electrocardiograms, toxicokinetics, organ weights, gross anatomy and histopathology were examined. After the administration, no deaths were observed; however, the dogs that received PDT showed skin swelling and ulceration, indicating that DVDMS-PDT induced a phototoxic effect. DVDMS led to an increase in blood coagulation in dogs in the 9 mg kg(-1) group and in the two PDT groups on Day 35, whereas it induced a decrease in dogs in the 3 mg kg(-1) group and in the two PDT groups on Day 49. The toxicokinetic study showed that the systematic exposure of DVDMS in dogs occurred in a dose-dependent manner, and DVDMS did not accumulate in blood plasma. The DVDMS-based PDT group showed no obvious treatment-related pathological changes; however, slight or mild brown-and-yellow pigmentation of DVDMS (or its metabolite) was observed to deposit in the liver, spleen, local lymph nodes and marrow of dogs in the mid- and high-dose groups, as well as the high-dose PDT group. In females, the absolute and relative spleen weights increased in dogs in the 9 mg kg(-1) DVDMS groups with and without PDT during the

  15. Safety assessment in plant layout design using indexing approach: implementing inherent safety perspective. Part 2-Domino Hazard Index and case study.

    PubMed

    Tugnoli, Alessandro; Khan, Faisal; Amyotte, Paul; Cozzani, Valerio

    2008-12-15

    The design of layout plans requires adequate assessment tools for the quantification of safety performance. The general focus of the present work is to introduce an inherent safety perspective at different points of the layout design process. In particular, index approaches for safety assessment and decision-making in the early stages of layout design are developed and discussed in this two-part contribution. Part 1 (accompanying paper) of the current work presents an integrated index approach for safety assessment of early plant layout. In the present paper (Part 2), an index for evaluation of the hazard related to the potential of domino effects is developed. The index considers the actual consequences of possible escalation scenarios and scores or ranks the subsequent accident propagation potential. The effects of inherent and passive protection measures are also assessed. The result is a rapid quantification of domino hazard potential that can provide substantial support for choices in the early stages of layout design. Additionally, a case study concerning selection among various layout options is presented and analyzed. The case study demonstrates the use and applicability of the indices developed in both parts of the current work and highlights the value of introducing inherent safety features early in layout design.

  16. Correlates of local safety-related concerns in a Swedish Community: a cross-sectional study

    PubMed Central

    Kullberg, Agneta; Karlsson, Nadine; Timpka, Toomas; Lindqvist, Kent

    2009-01-01

    Background Crime in a neighbourhood has been recognized as a key stressor in the residential environment. Fear of crime is related to risk assessment, which depends on the concentration of objective risk in time and space, and on the presence of subjective perceived early signs of imminent hazard. The aim of the study was to examine environmental, socio-demographic, and personal correlates of safety-related concerns at the local level in urban communities. The specific aim was to investigate such correlates in contiguous neighbourhoods in a Swedish urban municipality. Methods A cross-sectional study design was used to investigate three neighbourhood settings with two pair-wise conterminous but socially contrasting areas within each setting. Crime data were retrieved from police records. Study data were collected through a postal questionnaire distributed to adult residents (n = 2476) (response rate 56%). Composite dimensions of perceived residential safety were derived through a factor analysis. Logistic regression analysis was used to examine associations between high-level scores of the three safety-related dimensions and area-level crime rate, being a victim of crime, area reputation, gender, age, education, country of birth, household civil status and type of housing. Results Three composite dimensions of perceived residential safety were identified: (I) structural indicators of social disorder; (II) contact with disorderly behavior; and (III) existential insecurity. We found that area-level crime rates and individual-level variables were associated with the dimensions structural indicators of social disorder and existential insecurity, but only individual-level variables were associated with the dimension contact with disorderly behavior. Self-assessed less favorable area reputation was found to be strongly associated with all three factors. Being female accorded existential insecurity more than being a victim of crime. Conclusion We have identified

  17. What Counts? An Ethnographic Study of Infection Data Reported to a Patient Safety Program

    PubMed Central

    Dixon-Woods, Mary; Leslie, Myles; Bion, Julian; Tarrant, Carolyn

    2012-01-01

    Context Performance measures are increasingly widely used in health care and have an important role in quality. However, field studies of what organizations are doing when they collect and report performance measures are rare. An opportunity for such a study was presented by a patient safety program requiring intensive care units (ICUs) in England to submit monthly data on central venous catheter bloodstream infections (CVC-BSIs). Methods We conducted an ethnographic study involving ∼855 hours of observational fieldwork and 93 interviews in 17 ICUs plus 29 telephone interviews. Findings Variability was evident within and between ICUs in how they applied inclusion and exclusion criteria for the program, the data collection systems they established, practices in sending blood samples for analysis, microbiological support and laboratory techniques, and procedures for collecting and compiling data on possible infections. Those making decisions about what to report were not making decisions about the same things, nor were they making decisions in the same way. Rather than providing objective and clear criteria, the definitions for classifying infections used were seen as subjective, messy, and admitting the possibility of unfairness. Reported infection rates reflected localized interpretations rather than a standardized dataset across all ICUs. Variability arose not because of wily workers deliberately concealing, obscuring, or deceiving but because counting was as much a social practice as a technical practice. Conclusions Rather than objective measures of incidence, differences in reported infection rates may reflect, at least to some extent, underlying social practices in data collection and reporting and variations in clinical practice. The variability we identified was largely artless rather than artful: currently dominant assumptions of gaming as responses to performance measures do not properly account for how categories and classifications operate in the

  18. Safety of bevacizumab in clinical practice for recurrent ovarian cancer: A retrospective cohort study

    PubMed Central

    SELLE, FRÉDÉRIC; EMILE, GEORGE; PAUTIER, PATRICIA; ASMANE, IRÈNE; SOARES, DANIELE G.; KHALIL, AHMED; ALEXANDRE, JEROME; LHOMMÉ, CATHERINE; RAY-COQUARD, ISABELLE; LOTZ, JEAN-PIERRE; GOLDWASSER, FRANÇOIS; TAZI, YOUSSEF; HEUDEL, PIERRE; PUJADE-LAURAINE, ERIC; GOUY, SÉBASTIEN; TREDAN, OLIVIER; BARBAZA, MARIE O.; ADY-VAGO, NORA; DUBOT, CORALINE

    2016-01-01

    The poor outcome of patients with recurrent ovarian cancer constitutes a continuous challenge for decision-making in clinical practice. In this setting, molecular targets have recently been identified, and novel compounds are now available. Bevacizumab has been introduced for the treatment of patients with ovarian cancer and is, to date, the most extensively investigated targeted therapy in this setting. However, potential toxicities are associated with the use of this monoclonal antibody. These toxicities have been reported in clinical trials, and can also be observed outside of trials. As limited data is currently available regarding the safety of bevacizumab treatment in daily clinical practice, the current retrospective study was designed to evaluate this. Data from 156 patients with recurrent ovarian cancer who had received bevacizumab treatment between January 2006 and June 2009 were retrospectively identified from the institutional records of five French centers. In contrast to clinical trials, the patients in the present study were not selected and had a heterogeneous profile according to their prior medical history, lines of treatment prior to bevacizumab introduction and number of relapses. The results first confirm the effect of heavy pretreatment on the occurrence of serious and fatal adverse events in clinical practice, as previously reported for clinical trials and for other retrospective cohort studies. Importantly, the data also demonstrates, for the first time, that medical history of hypertension is an independent predictive risk factor for the development of high-grade hypertension during bevacizumab treatment. These results thus suggest that treating physicians must consider all risk factors for managing bevacizumab toxicity prior to its introduction. Such risk factors include the time of bevacizumab introduction, a patient's history of hypertension and a low incidence of pre-existing obstructive disease. PMID:26998090

  19. Review of accidental safety studies for the European HCPB test blanket system

    NASA Astrophysics Data System (ADS)

    Boccaccini, L. V.; Ciattaglia, S.; Meyder, R.; Jin, X.

    2007-07-01

    This paper presents a review of safety studies for accidental sequences in the European solid breeder test blanket module (TBM) system. These studies are the starting point for the Preliminary Safety Analysis Report of ITER, under preparation to get the construction permit first and then later the operation licence. In general the reduced inventory of activation products and tritium associated with the TBM system makes the impact of this test system almost negligible on the overall safety risk of ITER. Nevertheless, the possibility of jeopardizing the ITER safety concept has been analysed in connection to the consequences of specific accident sequences, e.g. the pressurization of the vacuum vessel due to the He coolant blow-down, the hydrogen production from the Be-steam reaction, the possible interconnection between the port cell and the vacuum vessel causing air ingress and the necessity to assure heat removal in the short and long periods. In the frame of this assessment, three LOCA sequences have been selected as representative of accidents judged to cover all scenarios envisaged in Cat II to IV events involving the TBM, namely, in-vessel LOCA, ex-vessel LOCA and in-box LOCA.

  20. Strengthening leadership as a catalyst for enhanced patient safety culture: a repeated cross-sectional experimental study

    PubMed Central

    Kristensen, Solvejg; Christensen, Karl Bang; Jaquet, Annette; Møller Beck, Carsten; Sabroe, Svend; Bartels, Paul; Mainz, Jan

    2016-01-01

    Objectives Current literature emphasises that clinical leaders are in a position to enable a culture of safety, and that the safety culture is a performance mediator with the potential to influence patient outcomes. This paper aims to investigate staff's perceptions of patient safety culture in a Danish psychiatric department before and after a leadership intervention. Methods A repeated cross-sectional experimental study by design was applied. In 2 surveys, healthcare staff were asked about their perceptions of the patient safety culture using the 7 patient safety culture dimensions in the Safety Attitudes Questionnaire. To broaden knowledge and strengthen leadership skills, a multicomponent programme consisting of academic input, exercises, reflections and discussions, networking, and action learning was implemented among the clinical area level leaders. Results In total, 358 and 325 staff members participated before and after the intervention, respectively. 19 of the staff members were clinical area level leaders. In both surveys, the response rate was >75%. The proportion of frontline staff with positive attitudes improved by ≥5% for 5 of the 7 patient safety culture dimensions over time. 6 patient safety culture dimensions became more positive (increase in mean) (p<0.05). Frontline staff became more positive on all dimensions except stress recognition (p<0.05). For the leaders, the opposite was the case (p<0.05). Staff leaving the department after the first measurement had rated job satisfaction lower than the staff staying on (p<0.05). Conclusions The improvements documented in the patient safety culture are remarkable, and imply that strengthening the leadership can act as a significant catalyst for patient safety culture improvement. Further studies using a longitudinal study design are recommended to investigate the mechanism behind leadership's influence on patient safety culture, sustainability of improvements over time, and the association of change

  1. The Hermes safety strategy

    NASA Astrophysics Data System (ADS)

    Rosso, R.

    1992-08-01

    The principal safety objectives and safety assurance strategies of the Hermes space vehicle program are discussed. The highlights of the Hermes safety assurance strategy are reviewed with particular reference to risk identification, risk evaluation, risk reduction, and risk acceptance. The application of the safety assurance strategy to Phase I definition studies and safety objectives of the Hermes X 2000 mission are then discussed.

  2. STRengthening analytical thinking for observational studies: the STRATOS initiative.

    PubMed

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

    2014-12-30

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

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

    PubMed Central

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

    2014-01-01

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

  4. Monitoring product safety in the postmarketing environment.

    PubMed

    Sharrar, Robert G; Dieck, Gretchen S

    2013-10-01

    The safety profile of a medicinal product may change in the postmarketing environment. Safety issues not identified in clinical development may be seen and need to be evaluated. Methods of evaluating spontaneous adverse experience reports and identifying new safety risks include a review of individual reports, a review of a frequency distribution of a list of the adverse experiences, the development and analysis of a case series, and various ways of examining the database for signals of disproportionality, which may suggest a possible association. Regulatory agencies monitor product safety through a variety of mechanisms including signal detection of the adverse experience safety reports in databases and by requiring and monitoring risk management plans, periodic safety update reports and postauthorization safety studies. The United States Food and Drug Administration is working with public, academic and private entities to develop methods for using large electronic databases to actively monitor product safety. Important identified risks will have to be evaluated through observational studies and registries.

  5. "Lies, damned lies ..." and observational studies in comparative effectiveness research.

    PubMed

    Albert, Richard K

    2013-06-01

    A new federal initiative has allocated $1.1 billion to comparative effectiveness research, and many have emphasized the importance of including observational studies in this effort. The rationale for using observational studies to assess comparative effectiveness is based on concerns that randomized controlled trials (RCTs) are not "real world" because they enroll homogeneous patient populations, measure study outcomes that are not important to patients, use protocols that are overly complex, are conducted in specialized centers, and use study treatments that are not consistent with usual care, and that RCTs are not always feasible because of a lack of equipoise, the need to assess delayed endpoints, and concerns that they take years to complete and are expensive. This essay questions the validity of each of these proposed limitations, summarizes concerns raised about the accuracy of results generated by observational studies, provides some examples of discrepancies between results of observational studies and RCTs that pertain to pulmonary and critical care, and suggests that using observational studies for comparative effectiveness research may increase rather than decrease the cost of health care and may harm patients.

  6. Issues of reporting in observational studies in veterinary medicine.

    PubMed

    Sargeant, Jan M; O'Connor, Annette M

    2014-02-15

    Observational studies are common in veterinary medicine; the results may be used to inform decision-making, future research, or as inputs to systematic reviews or risk assessment. To be of use, the results must be published, all of the outcomes that were assessed must be included in the publication, and the research (methods and results) must be reported in sufficient detail that the reader can evaluate the internal and external validity. In human healthcare, concerns about the completeness of reporting - and evidence that poor reporting is associated with study results - have led to the creation of reporting guidelines; these include the STROBE statement for observational studies. There is evidence from a limited body of research that there also are reporting inadequacies in veterinary observational studies. There are differences between human and veterinary observational studies that might be relevant to recommendations for reporting. Such differences include: the use of observational studies in animal populations for simultaneously estimating disease frequency and risk-factor identification; the distinction between the animal owners who consent to participate and the animals that are the study subjects; and the complexity of organizational levels inherent in animal research (in particular, for studies in livestock species). In veterinary medicine, it is common to have clustering within outcomes (due to animal grouping) and clustering of predictor variables. We argue that there is a compelling need for the scientific community involved in veterinary observational studies to use the STROBE statement, use an amended version of STROBE, or to develop and use reporting guidelines that are specific to veterinary medicine to improve reporting of these studies.

  7. The contribution of on-road studies of road user behaviour to improving road safety.

    PubMed

    Lenné, Michael G

    2013-09-01

    For over 40 years transport safety researchers have been using methods of vehicle instrumentation to gain greater insights into the factors that contribute to road user crash risk and the associated crash factors. In the previous decade in particular the widespread availability of lower cost and more advanced methods of vehicle instrumentation and recording technologies are supporting the increasing number of on-road research studies worldwide. The design of these studies ranges from multi-method studies using instrumented test vehicles and defined driving routes, to field operational tests, through to much larger and more naturalistic studies. It is timely to assess the utility of these methods for studying the influences of driver characteristics and states, the design and operation of the road system, and the influences of in-vehicle technologies on behaviour and safety for various road user groups. This special issue considers the extent to which on-road studies using vehicle instrumentation have been used to advance knowledge across these areas of road safety research. The papers included in this issue illustrate how research using instrumented test vehicles continues to generate new knowledge, and how the larger scale United States and European naturalistic and field operational test studies are providing a wealth of data about road user behaviour in real traffic. This is balanced with a number of studies that present methodological developments in data collection and analysis methods that, while promising, need further validation. The use of on-road methods to accurately describe the behaviours occurring in everyday real-world conditions, to quantify risks for safety critical events, and an improved understanding of the factors that contribute to risk, clearly has huge potential to promote further road trauma reductions.

  8. Surveying Science Safety.

    ERIC Educational Resources Information Center

    Gerlovich, Jack A.; Parsa, Rahul

    2002-01-01

    Reports the results of a National Science Teachers Association (NSTA) study that analyzed science classroom safety. Examines the potential need for a national safety indexing system to rank states with regard to science safety. (DDR)

  9. Teacher Effectiveness and Causal Inference in Observational Studies

    ERIC Educational Resources Information Center

    Rose, Roderick A.

    2013-01-01

    An important target of education policy is to improve overall teacher effectiveness using evidence-based policies. Randomized control trials (RCTs), which randomly assign study participants or groups of participants to treatment and control conditions, are not always practical or possible and observational studies using rigorous quasi-experimental…

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

    PubMed Central

    Barnett, Michael L; Mehrotra, Ateev

    2016-01-01

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

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

    SciTech Connect

    Ackerman, S.A.; Inoue, Toshiro

    1994-03-01

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

  12. Technology Solutions Case Study: Combustion Safety for Appliances Using Indoor Air

    SciTech Connect

    2014-05-01

    This case study describes how to assess and carry out the combustion safety procedures for appliances and heating equipment that uses indoor air for combustion in low-rise residential buildings. Only appliances installed in the living space, or in an area freely communicating with the living space, vented alone or in tandem with another appliance are considered here. This document is for inspectors, auditors, and technicians working in homes where energy upgrades are being conducted whether or not air infiltration control is included in the package of measures being applied. In the indoor combustion air case, guidelines summarized here are based on language provided in several of the codes to establish minimum requirements for the space using simplified prescriptive measures. In addition, building performance testing procedures are provided by testing agencies. The codes in combination with the test procedures offer comprehensive combustion safety coverage to address safety concerns, allowing inexperienced residential energy retrofit inspectors to effectively address combustion safety issues and allow energy retrofits to proceed.

  13. A multicentre open-label safety and efficacy study of tetrodotoxin for cancer pain

    PubMed Central

    Hagen, N.A.; Lapointe, B.; Ong–Lam, M.; Dubuc, B.; Walde, D.; Gagnon, B.; Love, R.; Goel, R.; Hawley, P.; Ngoc, A. Ho; du Souich, P.

    2011-01-01

    Background Cancer pain is highly prevalent, and existing treatments are often insufficient to provide adequate relief. Objectives We assessed the long-term safety and efficacy of subcutaneous tetrodotoxin treatment in reducing the intensity of chronic cancer-related pain. Methods In this multicentre open-label longitudinal trial, 30 μg tetrodotoxin was administered subcutaneously twice daily for 4 days in a heterogeneous cohort of patients with persistent pain despite opioids and other analgesics. “Responder” was defined as a mean reduction of 30% or more in pain intensity from baseline; and “clinical responder” as some pain reduction, but less than 30%, plus agreement on the part of both the patient and the physician that a meaningful analgesic response to treatment had occurred. Results Of 45 patients who entered the longitudinal trial, 41 had sufficient data for analysis. Of all 45 patients, 21 (47%) met the criteria for “responder” [16 patients (36%)] or “clinical responder” [5 patients (11%)]. Onset of pain relief was typically cumulative over days, and after administration ended, the analgesic effect subsided over the course of a few weeks. No evidence of loss of analgesic effect was observed during subsequent treatments (2526 patient–days in total and a maximum of 400 days in 1 patient). One patient withdrew from the study because of adverse events. Toxicity was usually mild (82%) or moderate (13%), and remained so through subsequent treatment cycles, with no evidence of cumulative toxicity or tolerance. Conclusions Long-term treatment with tetrodotoxin is associated with acceptable toxicity and, in a substantial minority of patients, resulted in a sustained analgesic effect. Further study of tetrodotoxin for moderate-to-severe cancer pain is warranted. PMID:21655148

  14. [Efficacy, tolerability and safety of cyclosporine for microemulsion in the treatment of active rheumatoid arthritis. Open study].

    PubMed

    Marcos, J C; Maccagno, A; Gutfraind, E; Garsd, A; Messina, D O; Maldonado Cocco, J; Battagliotti, C; Onetti, C M; Tate, G; Venarotti, H O; Grosman, H; Díaz, E A; Otero, A B

    2000-01-01

    Cyclosporine for microemulsion has been widely used in the treatment of rheumatoid arthritis (RA) with remarkably good results over progression of joint damage, as reported by the GRISAR Study. A local group in Argentina, performed a prospective, open label study (Neo-Ra-02), consisting of 12 centres which recruited 50 RA patients, who were followed during 6 months in order to assess efficacy, tolerability and safety of cyclosporine microemulsion in the treatment of RA. Efficacy parameters were: morning stiffness, functional evaluation (HAQ, Lee and Ritchie index) and laboratory and radiological (Larsen score) assessments. Safety parameters were: blood pressure and renal, liver and hematological laboratory data. Patients criteria for participation were: presence of active RA (as defined by the ACR), Steinbrocker anatomic and functional grade I to III, disease evolution no longer than 5 years, no previous history of hypertension, renal or liver disease and absence of DMARDs use during the previous 2 months. There was a statistically significant decrease in morning stiffness and in pain evolution. Improvement became evident after 4 weeks of treatment. Reduction of Ritchie index was significant also at 4 weeks and the same observation was made with tenderness and swollen joint scores. Regarding evolution of CRP and RF, a statistically significant reduction was observed only in positive RF. Safety parameters showed no significant increase in serum creatinine or uric acid: 6/50 patients developed mild hypertension with only a significant increase in systolic blood pressure in comparison with baseline. Cyclosporine microemulsion demonstrated efficacy with minimal adverse events (12% mild hypertension) when appropriately monitored and administered in low doses (3 mg/kg/day).

  15. A proposal for financing postmarketing drug safety studies by augmenting FDA user fees.

    PubMed

    Carpenter, Daniel

    2005-01-01

    I propose to raise funds for postapproval studies of long-term drug safety by augmenting the existing "user-fee" system. Fees would be raised by an amount deemed optimal for revenue collection, and the U.S. Food and Drug Administration (FDA) would direct the incremental funds to a combination of randomized controlled trials, epidemiological studies, and postmarketing surveillance. User-fee augmentation is an achievable, incremental reform that would subsidize information that is now undersupplied in the U.S. health care system; spread the burden of funding postmarketing safety studies among pharmaceutical sponsors; and help restore public, scientific, and professional confidence in the FDA and its user-fee system.

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

    NASA Technical Reports Server (NTRS)

    Paciesas, William S.

    2002-01-01

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

  17. Safety and Efficacy Profile of Commercial Veterinary Vaccines against Rift Valley Fever: A Review Study

    PubMed Central

    2016-01-01

    Rift Valley Fever (RVF) is an infectious illness with serious clinical manifestations and health consequences in humans as well as a wide range of domestic ruminants. This review provides significant information about the prevention options of RVF along with the safety-efficacy profile of commercial vaccines and some of RVF vaccination strategies. Information presented in this paper was obtained through a systematic investigation of published data about RVF vaccines. Like other viral diseases, the prevention of RVF relies heavily on immunization of susceptible herds with safe and cost-effective vaccine that is able to confer long-term protective immunity. Several strains of RVF vaccines have been developed and are available in commercial production including Formalin-Inactivated vaccine, live attenuated Smithburn vaccine, and the most recent Clone13. Although Formalin-Inactivated vaccine and live attenuated Smithburn vaccine are immunogenic and widely used in prevention programs, they proved to be accompanied by significant concerns. Despite Clone13 vaccine being suggested as safe in pregnant ewes and as highly immunogenic along with its potential for differentiating infected from vaccinated animals (DIVA), a recent study raised concerns about the safety of the vaccine during the first trimester of gestation. Accordingly, RVF vaccines that are currently available in the market to a significant extent do not fulfill the requirements of safety, potency, and DIVA. These adverse effects stressed the need for developing new vaccines with an excellent safety profile to bridge the gap in safety and immunity. Bringing RVF vaccine candidates to local markets besides the absence of validated serological test for DIVA remain the major challenges of RVF control. PMID:27689098

  18. Integration of Active and Passive Safety Technologies--A Method to Study and Estimate Field Capability.

    PubMed

    Hu, Jingwen; Flannagan, Carol A; Bao, Shan; McCoy, Robert W; Siasoco, Kevin M; Barbat, Saeed

    2015-11-01

    The objective of this study is to develop a method that uses a combination of field data analysis, naturalistic driving data analysis, and computational simulations to explore the potential injury reduction capabilities of integrating passive and active safety systems in frontal impact conditions. For the purposes of this study, the active safety system is actually a driver assist (DA) feature that has the potential to reduce delta-V prior to a crash, in frontal or other crash scenarios. A field data analysis was first conducted to estimate the delta-V distribution change based on an assumption of 20% crash avoidance resulting from a pre-crash braking DA feature. Analysis of changes in driver head location during 470 hard braking events in a naturalistic driving study found that drivers' head positions were mostly in the center position before the braking onset, while the percentage of time drivers leaning forward or backward increased significantly after the braking onset. Parametric studies with a total of 4800 MADYMO simulations showed that both delta-V and occupant pre-crash posture had pronounced effects on occupant injury risks and on the optimal restraint designs. By combining the results for the delta-V and head position distribution changes, a weighted average of injury risk reduction of 17% and 48% was predicted by the 50th percentile Anthropomorphic Test Device (ATD) model and human body model, respectively, with the assumption that the restraint system can adapt to the specific delta-V and pre-crash posture. This study demonstrated the potential for further reducing occupant injury risk in frontal crashes by the integration of a passive safety system with a DA feature. Future analyses considering more vehicle models, various crash conditions, and variations of occupant characteristics, such as age, gender, weight, and height, are necessary to further investigate the potential capability of integrating passive and DA or active safety systems.

  19. [Study on method on post-marketing traditonal Chinese medicine safety assessment].

    PubMed

    Kou, Qiuai; Zhao, Suping; Feng, Guoshuang; Xie, Yanming

    2011-10-01

    Traditional Chinese medicine (TCM) safety assessment is an important content of post-marketing Chinese herbal medicine assessment and the primary question. It includes safety monitoring and safety evaluation. China has established the elementary system for the TCM safety monitoring, but did few things on safety evaluation. People have knew that the methods of pharmacoepidemiology have good practicability on drug safety assessment in recent years. This article analyzed three methods of pharmacoepidemiology used in post-marketing Chinese herbal medicine safety assessment. There are three examples that may give some suggestions to fellow doctors working for safety monitoring and evaluation of TCM.

  20. Nuclear safety

    NASA Technical Reports Server (NTRS)

    Buden, D.

    1991-01-01

    Topics dealing with nuclear safety are addressed which include the following: general safety requirements; safety design requirements; terrestrial safety; SP-100 Flight System key safety requirements; potential mission accidents and hazards; key safety features; ground operations; launch operations; flight operations; disposal; safety concerns; licensing; the nuclear engine for rocket vehicle application (NERVA) design philosophy; the NERVA flight safety program; and the NERVA safety plan.

  1. Scientific evaluation of the data-derived safety factors for the acceptable daily intake. Case study: diethylhexylphthalate.

    PubMed

    Morgenroth, V

    1993-01-01

    Diethylhexylphthalate causes peroxisome proliferation and is hepatocarcinogenic in rodents; it also displays reproductive and developmental toxicity in a variety of mammalian and non-mammalian species. These manifestations of toxicity have each been separately evaluated for the development of a data-derived safety factor and Tolerable Daily Intake (TDI). Using hepatocarcinogenicity as the pivotal study, the nature of toxicity factor of 10 is applicable and there are no adequate studies demonstrating a No-Observed-Adverse-Effect Level (NOAEL). If studies of less statistical sensitivity are used to derive the NOAEL and a factor of 0.1 is used for the relative sensitivity to humans of peroxisome proliferation (assuming this is linked mechanistically to carcinogenesis), a TDI of 1 mg/kg bw is obtained. The data-derived safety factor using peroxisomal proliferation as the pivotal end-point is 6.25, since the factor from trans-species toxicodynamics is 0.01, and the TDI derived from the NOAEL for peroxisome proliferation is thus 8 mg/kg bw. If teratogenicity is used as the pivotal study, the nature of toxicity attracts a factor of 10 and all the other aspects take default values because of the limited availability of relevant toxicodynamic and toxicokinetic data. The TDI derived from the NOAEL for teratogenicity is then 0.04 mg/kg bw and this confirms teratogenicity as the limiting aspect of toxicity defining the TDI. It also identifies the fact that appropriate toxicokinetic and toxicodynamic data related to the pregnant animal and fetus would facilitate a re-evaluation of the safety factor and TDI by replacing the current default values by data-derived values.

  2. Methods and Processes of Developing the Strengthening the Reporting of Observational Studies in Epidemiology-Veterinary (STROBE-Vet) Statement.

    PubMed

    Sargeant, J M; O'Connor, A M; Dohoo, I R; Erb, H N; Cevallos, M; Egger, M; Ersbøll, A K; Martin, S W; Nielsen, L R; Pearl, D L; Pfeiffer, D U; Sanchez, J; Torrence, M E; Vigre, H; Waldner, C; Ward, M P

    2016-12-01

    Reporting of observational studies in veterinary research presents challenges that often are not addressed in published reporting guidelines. Our objective was to develop an extension of the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement that addresses unique reporting requirements for observational studies in veterinary medicine related to health, production, welfare, and food safety. We conducted a consensus meeting with 17 experts in Mississauga, Canada. Experts completed a premeeting survey about whether items in the STROBE statement should be modified or added to address unique issues related to observational studies in animal species with health, production, welfare, or food safety outcomes. During the meeting, each STROBE item was discussed to determine whether or not rewording was recommended, and whether additions were warranted. Anonymous voting was used to determine consensus. Six items required no modifications or additions. Modifications or additions were made to the STROBE items 1 (title and abstract), 3 (objectives), 5 (setting), 6 (participants), 7 (variables), 8 (data sources and measurement), 9 (bias), 10 (study size), 12 (statistical methods), 13 (participants), 14 (descriptive data), 15 (outcome data), 16 (main results), 17 (other analyses), 19 (limitations), and 22 (funding). The methods and processes used were similar to those used for other extensions of the STROBE statement. The use of this STROBE statement extension should improve reporting of observational studies in veterinary research by recognizing unique features of observational studies involving food-producing and companion animals, products of animal origin, aquaculture, and wildlife.

  3. Improving teamwork, trust and safety: an ethnographic study of an interprofessional initiative.

    PubMed

    Jones, Aled; Jones, Delyth

    2011-05-01

    This study explored the perceptions of staff in an interprofessional team based on a medical rehabilitation ward for older people, following the introduction of a service improvement programme designed to promote better teamworking. The study aimed to address a lack of in-depth qualitative research that could explain the day-to-day realities of interprofessional teamworking in healthcare. All members of the team participated, (e.g. nurses, doctors, physiotherapists, social worker, occupational therapists), and findings suggest that interprofessional teamworking improved over the 12-month period. Four themes emerged from the data offering insights into the development and effects of better interprofessional teamworking: the emergence of collegial trust within the team, the importance of team meetings and participative safety, the role of shared objectives in conflict management and the value of autonomy within the team. Reductions in staff sickness/absence levels and catastrophic/major patient safety incidents were also detected following the introduction of the service improvement programme.

  4. Yttrium-90 Radioembolization for Unresectable Standard-chemorefractory Intrahepatic Cholangiocarcinoma: Survival, Efficacy, and Safety Study

    SciTech Connect

    Rafi, Shoaib; Piduru, Sarat M.; El-Rayes, Bassel; Kauh, John S.; Kooby, David A.; Sarmiento, Juan M.; Kim, Hyun S.

    2013-04-15

    To assess the overall survival, efficacy, and safety of radioembolization with yttrium-90 (Y90) for unresectable standard-chemorefractory intrahepatic cholangiocarcinoma (ICC). Patients with unresectable standard-chemorefractory ICC treated with Y90 were studied. Survival was calculated from the date of first Y90 procedure. Tumor response was assessed with the Response Evaluation Criteria in Solid Tumors criteria on follow-up computed tomography or magnetic resonance imaging scans. National Cancer Institute Common Terminology Criteria (NCI CTCAE), version 3, were used for complications. Statistical analysis was performed by the Kaplan-Meier estimator by the log rank test. Nineteen patients underwent a total of 24 resin-based Y90 treatments. Median survival from the time of diagnosis and first Y90 procedure was 752 {+-} 193 [95 % confidence interval (CI) 374-1130] and 345 {+-} 128 (95 % CI 95-595) days, respectively. Median survival with Eastern Cooperative Oncology Group (ECOG) performance status 1 (n = 15) and ECOG performance status 2 (n = 4) was 450 {+-} 190 (95 % CI 78-822) and 345 {+-} 227 (95 % CI 0-790) days, respectively (p = .214). Patients with extrahepatic metastasis (n = 11) had a median survival of 404 {+-} 309 (95 % CI 0-1010) days versus 345 {+-} 117 (95 % CI 115-575) days for patients without metastasis (n = 8) (p = .491). No mortality was reported within 30 days from first Y90 radioembolization. One patient developed grade 3 thrombocytopenia as assessed by NCI CTCAE. Fatigue and transient abdominal pain were observed in 4 (21 %) and 6 (32 %) patients, respectively. Y90 radioembolization is effective for unresectable standard-chemorefractory ICC.

  5. Studies of the field efficacy and safety of a single-dose Mycoplasma hyopneumoniae vaccine for pigs.

    PubMed

    Dawson, A; Harvey, R E; Thevasagayam, S J; Sherington, J; Peters, A R

    2002-11-02

    The field efficacy and safety of a single-dose Mycoplasma hyopneumoniae vaccine were evaluated in three-to five-week-old pigs. Two field efficacy studies were conducted, one in England with 673 pigs, and one in Germany with 719 pigs. The pigs were injected intramuscularly with either the vaccine or saline (control) at a ratio of 2:1 and reared under commercial conditions to slaughter weight. The efficacy of the vaccine was evaluated by comparing the lung lesions associated with infection with M. hyopneumoniae in the control and vaccinated animals postmortem. In both countries the vaccinated pigs had a significantly lower percentage of lung lesion scores, in England 5.7 v 10.2 per cent (P = 0.0022) and in Germany 3.9 v 7.7 per cent (P = 0.0056). In Germany the average daily weight gain (ADG) of the vaccinated pigs was significantly higher (639 g v 616 g) (P = 0.0205). In both countries and in both the treated and control animals there was a significant negative correlation between the ADG and the lung lesion score (P = 0.0001). Two safety trials were conducted, one in England and one in Germany, each with 75 pigs, and in each case 50 pigs were given the maximum batch release antigen titre of the vaccine and 25 were given saline. The safety of the vaccine was evaluated by observation for local and systemic reactions and any increases in rectal temperature. No abnormal reactions were observed in the vaccinated pigs and there was no significant difference between the mean peak rectal temperatures of the vaccinated and control pigs in either trial.

  6. Auto Weight and Public Safety a Statistical Study of Transportation Hazards.

    DTIC Science & Technology

    Analyses based on 1973 data from the Texas state automobile accident and registration records have been utilized in this study of the relationship...between passenger car weight and occupant safety. In particular, the research showed the following, (1) The relatively higher frequency of accidents in...large cars than in small cars is statistically very significant, (2) the relatively higher frequency of accidents resulting in fatal or serious

  7. Safety of daily ethanol locks for urinary catheters in critically ill children: a pilot study.

    PubMed

    Teppa, Beatriz E; Stockwell, Jana A

    2015-10-01

    Catheter-associated urinary tract infections represent a significant medical burden in critically ill children. Ethanol locks have been shown to be effective and safe for central line-associated bloodstream infection prevention and we propose utilizing this strategy for urinary catheters. Because this has never been done, we evaluated its safety with a pilot study hypothesizing that ethanol locks in urinary catheters would result in negligible alcohol absorption and negligible irritation of the bladder.

  8. Safety of long-term use of linezolid: results of an open-label study

    PubMed Central

    Vazquez, Jose A; Arnold, Anthony C; Swanson, Robert N; Biswas, Pinaki; Bassetti, Matteo

    2016-01-01

    Objective The objective of this study was to assess the long-term safety of linezolid in patients with chronic infections requiring treatment for ≥6 weeks. Enhanced monitoring for optic neuropathy was included to characterize the early development of this side effect and to identify ophthalmologic tests that might be valuable in early detection of this event. Methods This was a multicenter, open-label, pilot study of patients aged ≥18 years on long-term linezolid therapy. Matched control patients were included for baseline assessment comparison. Patients were assessed at study entry, monthly while on treatment, at the end of treatment, and 30 days following the last dose. Aggregate ocular safety data were reviewed. Response to treatment was reported. Results The study was terminated owing to slow enrollment. Twenty-four patients received linezolid; nine patients were included as matched controls. Linezolid was prescribed for a median of 80.5 days (range, 50–254 days). In patients with a reported clinical outcome, the majority were considered improved or cured. Common treatment-related adverse events (AEs) included anemia, peripheral neuropathy, polyneuropathy, vomiting, and asthenia, and were consistent with the known safety profile. Most AEs resolved or stabilized with discontinuation of treatment. Results of ophthalmologic tests in the one case adjudicated as probable linezolid-associated optic neuropathy revealed abnormal color vision, characteristic changes in the optic disk, and central scotomas in each eye. Conclusion In our small population, linezolid was generally well tolerated and AEs were consistent with the known safety profile. Extensive ophthalmologic testing of all 24 linezolid-treated patients identified one case adjudicated as probable, linezolid-associated optic neuropathy. PMID:27621644

  9. Recent neutronics developments for reactor safety studies with SIMMER code at KIT

    NASA Astrophysics Data System (ADS)

    Rineiski, A.; Marchetti, M.; Andriolo, L.; Gabrielli, F.

    2017-01-01

    The SIMMER family of codes is applied for safety studies of sodium fast reactors and reactors of other types. Both neutronics and fluid-dynamics parts of SIMMER are under development. In the paper new neutronics capabilities are presented. In particular developments for neutron transport solvers and a new technique for taking into account thermal expansion effects are described. These new capabilities facilitate 3D simulations and improve accuracy of modelling for the initiation transient phase during a hypothetical severe accident.

  10. A phase I safety and pharmacokinetic study of ATX-101: injectable, synthetic deoxycholic acid for submental contouring.

    PubMed

    Walker, Patricia; Fellmann, Jere; Lizzul, Paul F

    2015-03-01

    ATX-101 (deoxycholic acid [DCA] injection) is a proprietary formulation of pure synthetic DCA. When injected into subcutaneous fat, ATX-101 results in focal adipocytolysis, the targeted destruction of fat cells. ATX-101 is undergoing investigation as an injectable drug for contouring the submental area by reducing submental fat (SMF). The purpose of this study was to evaluate the safety and pharmacokinetics (PK) of the maximal therapeutic dose of ATX-101 (100 mg total dose). Following PK evaluation of endogenous DCA, subjects (N=24) received subcutaneous injections of ATX-101 (2 mg/cm2, with or without 0.9% benzyl alcohol) into SMF; PK evaluation was repeated periodically over 24 hours. Endogenous DCA plasma concentrations measured prior to injection were highly variable within and between subjects. Similarly, following ATX-101 injection, DCA plasma concentrations were highly variable, peaked rapidly, and returned to the range observed for endogenous values by 24 hours postdose. All subjects experienced at least 1 adverse event (AE). No death, serious AE, or AE-related discontinuations occurred. The majority of AEs were transient, associated with the area treated, and of mild or moderate severity. No clinically significant changes were reported for laboratory test results, vital signs, or Holter electrocardiograms postdosing. These data support the favorable safety and efficacy observations of ATX-101 as an injectable drug to reduce SMF.

  11. Intravitreal Injection of Bone Marrow Mesenchymal Stem Cells in Patients with Advanced Retinitis Pigmentosa; a Safety Study

    PubMed Central

    Satarian, Leila; Nourinia, Ramin; Safi, Sare; Kanavi, Mozhgan Rezaei; Jarughi, Neda; Daftarian, Narsis; Arab, Leila; Aghdami, Nasser; Ahmadieh, Hamid; Baharvand, Hossein

    2017-01-01

    Purpose: To examine the safety of a single intravitreal injection of autologous bone Marrow Mesenchymal stem cells (MSCs) in patients with advanced retinitis pigmentosa (RP). Methods: A prospective, phase I, nonrandomized, open-label study was conducted on 3 eyes of 3 volunteers with advanced RP. Visual acuity, slit-lamp examination, fundus examination, optical coherence tomography, fundus auto-fluorescence, fluorescein angiography and multifocal electroretinography were performed before and after an intravitreal injection of approximately one-million MSCs. The patients were followed for one year. Further evaluation of MSCs was performed by injection of these cells into the mouse vitreous cavity. Results: No, adverse events were observed in eyes of 2 out of 3 patients after transplantation of MSCs. These patients reported improvements in perception of the light after two weeks, which lasted for 3 months. However, severe fibrous tissue proliferation was observed in the vitreous cavity and retrolental space of the third patient's eye, which led to tractional retinal detachment (TRD), iris neovascularization and formation of mature cataract. Injection of this patient's MSCs into the vitreous cavity of mice also resulted in fibrosis; however, intravitreal injections of the two other patients' cells into the mouse vitreous did not generate any fibrous tissue. Conclusion: Intravitreal injection of autologous bone marrow MSCs into patients' eyes with advanced RP does not meet safety standards. Major side effects of this therapy can include fibrosis and TRD. We propose thorough evaluation of MSCs prior to transplantation by intravitreal injection in the laboratory animals.\\ PMID:28299008

  12. Transcutaneous Vagus Nerve Stimulation: Retrospective Assessment of Cardiac Safety in a Pilot Study

    PubMed Central

    Kreuzer, Peter M.; Landgrebe, Michael; Husser, Oliver; Resch, Markus; Schecklmann, Martin; Geisreiter, Florian; Poeppl, Timm B.; Prasser, Sarah Julia; Hajak, Goeran; Langguth, Berthold

    2012-01-01

    Background: Vagus nerve stimulation has been successfully used as a treatment strategy for epilepsy and affective disorders for years. Transcutaneous vagus nerve stimulation (tVNS) is a new non-invasive method to stimulate the vagus nerve, which has been shown to modulate neuronal activity in distinct brain areas. Objectives: Here we report effects of tVNS on cardiac function from a pilot study, which was conducted to evaluate the feasibility and safety of tVNS for the treatment of chronic tinnitus. Methods: Twenty-four patients with chronic tinnitus underwent treatment with tVNS over 3–10 weeks in an open single-armed pilot study. Safety criteria and practical usability of the neurostimulating device were to investigate by clinical examination and electrocardiography at baseline and at several visits during and after tVNS treatment (week 2, 4, 8, 16, and 24). Results: Two adverse cardiac events (one classified as a severe adverse event) were registered but considered very unlikely to have been caused by the tVNS device. Retrospective analyses of electrocardiographic parameters revealed a trend toward shortening of the QRS complex after tVNS. Conclusion: To our knowledge this is one of the first studies investigating feasibility and safety of tVNS in a clinical sample. In those subjects with no known pre-existing cardiac pathology, preliminary data do not indicate arrhythmic effects of tVNS. PMID:22891061

  13. Landmark estimation of survival and treatment effects in observational studies.

    PubMed

    Parast, Layla; Griffin, Beth Ann

    2017-04-01

    Clinical studies aimed at identifying effective treatments to reduce the risk of disease or death often require long term follow-up of participants in order to observe a sufficient number of events to precisely estimate the treatment effect. In such studies, observing the outcome of interest during follow-up may be difficult and high rates of censoring may be observed which often leads to reduced power when applying straightforward statistical methods developed for time-to-event data. Alternative methods have been proposed to take advantage of auxiliary information that may potentially improve efficiency when estimating marginal survival and improve power when testing for a treatment effect. Recently, Parast et al. (J Am Stat Assoc 109(505):384-394, 2014) proposed a landmark estimation procedure for the estimation of survival and treatment effects in a randomized clinical trial setting and demonstrated that significant gains in efficiency and power could be obtained by incorporating intermediate event information as well as baseline covariates. However, the procedure requires the assumption that the potential outcomes for each individual under treatment and control are independent of treatment group assignment which is unlikely to hold in an observational study setting. In this paper we develop the landmark estimation procedure for use in an observational setting. In particular, we incorporate inverse probability of treatment weights (IPTW) in the landmark estimation procedure to account for selection bias on observed baseline (pretreatment) covariates. We demonstrate that consistent estimates of survival and treatment effects can be obtained by using IPTW and that there is improved efficiency by using auxiliary intermediate event and baseline information. We compare our proposed estimates to those obtained using the Kaplan-Meier estimator, the original landmark estimation procedure, and the IPTW Kaplan-Meier estimator. We illustrate our resulting reduction in bias

  14. SABRE observations of Pi2 pulsations: case studies

    NASA Astrophysics Data System (ADS)

    Bradshaw, E. G.; Lester, M.

    1997-01-01

    The characteristics of substorm-associated Pi2 pulsations observed by the SABRE coherent radar system during three separate case studies are presented. The SABRE field of view is well positioned to observe the differences between the auroral zone pulsation signature and that observed at mid-latitudes. During the first case study the SABRE field of view is initially in the eastward electrojet, equatorward and to the west of the substorm-enhanced electrojet current. As the interval progresses, the western, upward field-aligned current of the substorm current wedge moves westward across the longitudes of the radar field of view. The westward motion of the wedge is apparent in the spatial and temporal signatures of the associated Pi2 pulsation spectra and polarisation sense. During the second case study, the complex field-aligned and ionospheric currents associated with the pulsation generation region move equatorward into the SABRE field of view and then poleward out of it again after the third pulsation in the series. The spectral content of the four pulsations during the interval indicate different auroral zone and mid-latitude signatures. The final case study is from a period of low magnetic activity when SABRE observes a Pi2 pulsation signature from regions equatorward of the enhanced substorm currents. There is an apparent mode change between the signature observed by SABRE in the ionosphere and that on the ground by magnetometers at latitudes slightly equatorward of the radar field of view. The observations are discussed in terms of published theories of the generation mechanisms for this type of pulsation. Different signatures are observed by SABRE depending on the level of magnetic activity and the position of the SABRE field of view relative to the pulsation generation region. A twin source model for Pi2 pulsation generation provides the clearest explanation of the signatures observed Acknowledgements. The authors are grateful to Prof. D. J. Southwood

  15. Criticality safety study of the MSRE Fuel Drain Tank Cell in Building 7503

    SciTech Connect

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

    1994-01-01

    This report provides a criticality safety study of the molten salt reactor fuel currently being stored in the Fuel Drain Tank (FDT) Cell of the Molten Salt Reactor Experiment (MSRE) facility (Building 7503) located in the Melton Valley area of the Oak Ridge National Laboratory. The FDTs contain approximately 36 kg of uranium consisting primarily of {sup 233}U, some plutonium, and fission products in a solidified fluoride salt mixture. The nominal composition of the fluoride salt mixture in the FDTs is 42.16 wt % LiF, 35.79 wt % BeF{sub 2}, 21.01 wt % ZrF{sub 4}, 1.02 wt % UF{sub 4}, and 0.02 wt % PuF{sub 3}. The historic criticality safety study does not meet current standards. This work is in support of a new nuclear criticality safety analysis and approval update. Questions concerning the degree of subcriticality associated with the material in its current state and in its most reactive credible upset condition are addressed. The safety study consists of two parts. In the first part, the FDT Cell was modeled using KENO V.a and analyzed using a variety of cross-section sets. The base FDT Cell model was then modified to represent the most reactive credible upset conditions and analyzed. The second part consists of establishing a benchmark for the FDT Cell. Because of the lack of any other relevant benchmark experiments, the original MSRE was also modeled in KENO V.a and analyzed. The results of the reactor model were then compared with documented MSRE reactor conditions. The analysis shows that even under the most reactive credible upset conditions, the MSRE FDT Cell is significantly subcritical.

  16. Safety and tolerability of bosentan for digital ulcers in Japanese patients with systemic sclerosis: Prospective, multicenter, open-label study.

    PubMed

    Hamaguchi, Yasuhito; Sumida, Takayuki; Kawaguchi, Yasushi; Ihn, Hironobu; Tanaka, Sumiaki; Asano, Yoshihide; Motegi, Sei-Ichiro; Kuwana, Masataka; Endo, Hirahito; Takehara, Kazuhiko

    2017-01-01

    A multicenter, open-label study was performed to investigate the safety and tolerability of bosentan in Japanese patients with systemic sclerosis (SSc) and secondary digital ulcers. Twenty-eight patients were enrolled. The safety and tolerability of bosentan was monitored over 52 weeks of study treatment (primary end-point), while incidence and healing of digital ulcers were also assessed up to week 16. The following adverse events occurred in 5% or more of patients during the 52-week treatment period: upper respiratory tract infection (50.0%), abnormal liver function tests (42.9%), digital ulcers (25.0%), anemia (17.9%), peripheral edema (14.3%), diarrhea (10.7%), urinary tract infection (7.1%), arthralgia (7.1%), constipation (7.1%) and herpes zoster (7.1%). Eight patients experienced at least one serious adverse event, including drug-related serious adverse events in two patients, which were abnormal liver function tests and fluid retention (pericardial effusion) in one patient each. During the 16-week observation period, seven out of 28 patients (25%) developed new digital ulcers. In this study, adverse events were comparable with those previously reported with bosentan. Approximately half of the patients had adverse events associated with abnormal liver function tests, thus we conclude that liver function should be monitored regularly during treatment with bosentan.

  17. Efficacy and safety of growth hormone treatment in adults with growth hormone deficiency: a systematic review of studies on morbidity.

    PubMed

    van Bunderen, Christa C; van Varsseveld, Nadège C; Erfurth, Eva Marie; Ket, Johannes C F; Drent, Madeleine L

    2014-07-01

    Due to the positive effects demonstrated in randomized clinical trials on cardiovascular surrogate markers and bone metabolism, a positive effect of growth hormone (GH) treatment on clinically relevant end-points seems feasible. In this review, we discuss the long-term efficacy and safety of GH treatment in adult patients with growth hormone deficiency (GHD) with emphasis on morbidity: fatal and nonfatal cardiovascular disease (CVD) and stroke, fractures, fatal and nonfatal malignancies and recurrences, and diabetes mellitus. A positive effect of GH treatment on CVD and fracture risk could be concluded, but study design limitations have to be considered. Stroke and secondary brain tumours remained more prevalent. However, other contributing factors have to be taken into account. Regrowth and recurrences of (peri)pituitary tumours were not increased in patients with GH treatment compared to similar patients without GH treatment. All fatal and nonfatal malignancies were not more prevalent in GH-treated adults compared to the general population. However, follow-up time is still relatively short. The studies on diabetes are difficult to interpret, and more evidence is awaited. In clinical practice, a more individualized assessment seems appropriate, taking into consideration the underlying diagnosis of GHD, other treatment regimens, metabolic profile and the additional beneficial effects of GH set against the possible risks. Large and thoroughly conducted observational studies are needed and seem the only feasible way to inform the ongoing debate on health care costs, drug safety and clinical outcomes.

  18. A cross-sectional mixed methods study protocol to generate learning from patient safety incidents reported from general practice

    PubMed Central

    Carson-Stevens, Andrew; Hibbert, Peter; Avery, Anthony; Butlin, Amy; Carter, Ben; Cooper, Alison; Evans, Huw Prosser; Gibson, Russell; Luff, Donna; Makeham, Meredith; McEnhill, Paul; Panesar, Sukhmeet S; Parry, Gareth; Rees, Philippa; Shiels, Emma; Sheikh, Aziz; Ward, Hope Olivia; Williams, Huw; Wood, Fiona; Donaldson, Liam; Edwards, Adrian

    2015-01-01

    Introduction Incident reports contain descriptions of errors and harms that occurred during clinical care delivery. Few observational studies have characterised incidents from general practice, and none of these have been from the England and Wales National Reporting and Learning System. This study aims to describe incidents reported from a general practice care setting. Methods and analysis A general practice patient safety incident classification will be developed to characterise patient safety incidents. A weighted-random sample of 12 500 incidents describing no harm, low harm and moderate harm of patients, and all incidents describing severe harm and death of patients will be classified. Insights from exploratory descriptive statistics and thematic analysis will be combined to identify priority areas for future interventions. Ethics and dissemination The need for ethical approval was waivered by the Aneurin Bevan University Health Board research risk review committee given the anonymised nature of data (ABHB R&D Ref number: SA/410/13). The authors will submit the results of the study to relevant journals and undertake national and international oral presentations to researchers, clinicians and policymakers. PMID:26628526

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

    ERIC Educational Resources Information Center

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

    2015-01-01

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

  20. Scientific and Ethical Approaches for Observational Exposure Studies

    EPA Science Inventory

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

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

    NASA Technical Reports Server (NTRS)

    London, Julius

    1990-01-01

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

  2. Perspectives on Safety and Health among Migrant and Seasonal Farmworkers in the United States and Mexico: A Qualitative Field Study

    ERIC Educational Resources Information Center

    Stallones, Lorann; Acosta, Martha S. Vela; Sample, Pat; Bigelow, Philip; Rosales, Monica

    2009-01-01

    Context: A large number of hired farmworkers in the United States come from Mexico. Understanding safety and health concerns among the workers is essential to improving prevention programs. Purpose: The purpose of this pilot study was to obtain detailed information about safety and health concerns of hired farmworkers in Colorado and in Mexico.…

  3. An observational postmarketing safety registry of patients in the UK, Germany, and Switzerland who have been prescribed Sativex(®) (THC:CBD, nabiximols) oromucosal spray.

    PubMed

    Etges, Tilden; Karolia, Kari; Grint, Thomas; Taylor, Adam; Lauder, Heather; Daka, Brian; Wright, Stephen

    2016-01-01

    The global exposure of Sativex(®) (Δ(9)-tetrahydrocannabinol [THC]:cannabidiol [CBD], nabiximols) is estimated to be above 45,000 patient-years since it was given marketing approval for treating treatment-resistant spasticity in multiple sclerosis (MS). An observational registry to collect safety data from patients receiving THC:CBD was set up following its approval in the UK, Germany, and Switzerland, with the aim of determining its long-term safety in clinical practice. Twice a year, the Registry was opened to prescribing physicians to voluntarily report data on patients' use of THC:CBD, clinically significant adverse events (AEs), and special interest events. The Registry contains data from 941 patients with 2,213.98 patient-years of exposure. Within this cohort, 60% were reported as continuing treatment, while 83% were reported as benefiting from the treatment. Thirty-two percent of patients stopped treatment, with approximately one third citing lack of effectiveness and one quarter citing AEs. Psychiatric AEs of clinical significance were reported in 6% of the patients, 6% reported falls requiring medical attention, and suicidality was reported in 2%. Driving ability was reported to have worsened in 2% of patients, but improved in 7%. AEs were more common during the first month of treatment. The most common treatment-related AEs included dizziness (2.3%) and fatigue (1.7%). There were no signals to indicate abuse, diversion, or dependence. The long-term risk profile from the Registry is consistent with the known (labeled) safety profile of THC:CBD, and therefore supports it being a well-tolerated and beneficial medication for the treatment of MS spasticity. No evidence of new long-term safety concerns has emerged.

  4. An observational postmarketing safety registry of patients in the UK, Germany, and Switzerland who have been prescribed Sativex® (THC:CBD, nabiximols) oromucosal spray

    PubMed Central

    Etges, Tilden; Karolia, Kari; Grint, Thomas; Taylor, Adam; Lauder, Heather; Daka, Brian; Wright, Stephen

    2016-01-01

    The global exposure of Sativex® (Δ9-tetrahydrocannabinol [THC]:cannabidiol [CBD], nabiximols) is estimated to be above 45,000 patient-years since it was given marketing approval for treating treatment-resistant spasticity in multiple sclerosis (MS). An observational registry to collect safety data from patients receiving THC:CBD was set up following its approval in the UK, Germany, and Switzerland, with the aim of determining its long-term safety in clinical practice. Twice a year, the Registry was opened to prescribing physicians to voluntarily report data on patients’ use of THC:CBD, clinically significant adverse events (AEs), and special interest events. The Registry contains data from 941 patients with 2,213.98 patient-years of exposure. Within this cohort, 60% were reported as continuing treatment, while 83% were reported as benefiting from the treatment. Thirty-two percent of patients stopped treatment, with approximately one third citing lack of effectiveness and one quarter citing AEs. Psychiatric AEs of clinical significance were reported in 6% of the patients, 6% reported falls requiring medical attention, and suicidality was reported in 2%. Driving ability was reported to have worsened in 2% of patients, but improved in 7%. AEs were more common during the first month of treatment. The most common treatment-related AEs included dizziness (2.3%) and fatigue (1.7%). There were no signals to indicate abuse, diversion, or dependence. The long-term risk profile from the Registry is consistent with the known (labeled) safety profile of THC:CBD, and therefore supports it being a well-tolerated and beneficial medication for the treatment of MS spasticity. No evidence of new long-term safety concerns has emerged. PMID:27956834

  5. A longitudinal study of an intervention to improve road safety climate: climate as an organizational boundary spanner.

    PubMed

    Naveh, Eitan; Katz-Navon, Tal

    2015-01-01

    This study presents and tests an intervention to enhance organizational climate and expands existing conceptualization of organizational climate to include its influence on employee behaviors outside the organization's physical boundaries. In addition, by integrating the literatures of climate and work-family interface, the study explored climate spillover and crossover from work to the home domain. Focusing on an applied practical problem within organizations, we investigated the example of road safety climate and employees' and their families' driving, using a longitudinal study design of road safety intervention versus control groups. Results demonstrated that the intervention increased road safety climate and decreased the number of traffic violation tickets and that road safety climate mediated the relationship between the intervention and the number of traffic violation tickets. Road safety climate spilled over to the family domain but did not cross over to influence family members' driving.

  6. The status of blue straggler studies (II): observational properties

    NASA Astrophysics Data System (ADS)

    Xin, Yu; Deng, Li-Cai; Liang, Yan-Chun

    2006-09-01

    The obervational features of blue stragglers (BSs) show great differences among the different stellar systems, such as Galactic halo, open clusters, globular clusters, and dwarf galaxies. These differences reveal the distinctive formation of BSs and the physical conditions of the systems and their stellar populations. Therefore, studying the observational properties of BSs could be an effective method for studying the formation mechanisms of BSs, the evolution of single stars and binary systems, and the dynamical evolution of stellar systems.

  7. Thermal safety of ultrasound-enhanced ocular drug delivery: A modeling study

    SciTech Connect

    Nabili, Marjan; Geist, Craig E-mail: zderic@gwu.edu; Zderic, Vesna E-mail: zderic@gwu.edu

    2015-10-15

    Purpose: Delivery of sufficient amounts of therapeutic drugs into the eye for treatment of various ocular diseases is often a challenging task. Ultrasound was shown to be effective in enhancing ocular drug delivery in the authors’ previous in vitro and in vivo studies. Methods: The study reported here was designed to investigate the safety of ultrasound application and its potential thermal effects in the eye using PZFlex modeling software. The safety limit in this study was set as a temperature increase of no more than 1.5 °C based on regulatory recommendations and previous experimental safety studies. Acoustic and thermal specifications of different human eye tissues were obtained from the published literature. The tissues of particular interest in this modeling safety study were cornea, lens, and the location of optic nerve in the posterior eye. Ultrasound application was modeled at frequencies of 400 kHz–1 MHz, intensities of 0.3–1 W/cm{sup 2}, and exposure duration of 5 min, which were the parameters used in the authors’ previous drug delivery experiments. The baseline eye temperature was 37 °C. Results: The authors’ results showed that the maximal tissue temperatures after 5 min of ultrasound application were 38, 39, 39.5, and 40 °C in the cornea, 39.5, 40, 42, and 43 °C in the center of the lens, and 37.5, 38.5, and 39 °C in the back of the eye (at the optic nerve location) at frequencies of 400, 600, 800 kHz, and 1 MHz, respectively. Conclusions: The ocular temperatures reached at higher frequencies were considered unsafe based on current recommendations. At a frequency of 400 kHz and intensity of 0.8 W/cm{sup 2} (parameters shown in the authors’ previous in vivo studies to be optimal for ocular drug delivery), the temperature increase was small enough to be considered safe inside different ocular tissues. However, the impact of orbital bone and tissue perfusion should be included in future modeling efforts to determine the safety

  8. Thermal safety of ultrasound-enhanced ocular drug delivery: A modeling study

    PubMed Central

    Nabili, Marjan; Geist, Craig; Zderic, Vesna

    2015-01-01

    Purpose: Delivery of sufficient amounts of therapeutic drugs into the eye for treatment of various ocular diseases is often a challenging task. Ultrasound was shown to be effective in enhancing ocular drug delivery in the authors’ previous in vitro and in vivo studies. Methods: The study reported here was designed to investigate the safety of ultrasound application and its potential thermal effects in the eye using PZFlex modeling software. The safety limit in this study was set as a temperature increase of no more than 1.5 °C based on regulatory recommendations and previous experimental safety studies. Acoustic and thermal specifications of different human eye tissues were obtained from the published literature. The tissues of particular interest in this modeling safety study were cornea, lens, and the location of optic nerve in the posterior eye. Ultrasound application was modeled at frequencies of 400 kHz–1 MHz, intensities of 0.3–1 W/cm2, and exposure duration of 5 min, which were the parameters used in the authors’ previous drug delivery experiments. The baseline eye temperature was 37 °C. Results: The authors’ results showed that the maximal tissue temperatures after 5 min of ultrasound application were 38, 39, 39.5, and 40 °C in the cornea, 39.5, 40, 42, and 43 °C in the center of the lens, and 37.5, 38.5, and 39 °C in the back of the eye (at the optic nerve location) at frequencies of 400, 600, 800 kHz, and 1 MHz, respectively. Conclusions: The ocular temperatures reached at higher frequencies were considered unsafe based on current recommendations. At a frequency of 400 kHz and intensity of 0.8 W/cm2 (parameters shown in the authors’ previous in vivo studies to be optimal for ocular drug delivery), the temperature increase was small enough to be considered safe inside different ocular tissues. However, the impact of orbital bone and tissue perfusion should be included in future modeling efforts to determine the safety of this

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

    NASA Astrophysics Data System (ADS)

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

    2016-03-01

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

  10. Report to the NASA Administrator by the Aerospace Safety Advisory Panel on the Space Shuttle Program. Part 1: Observations and Conclusions

    NASA Technical Reports Server (NTRS)

    1976-01-01

    Each system was chosen on the basis of its importance with respect to crew safety and mission success. An overview of the systems management is presented. The space shuttle main engine, orbiter thermal protection system, avionics, external tanks and solid rocket boosters were examined. The ground test and ground support equipment programs were studied. Program management was found to have an adequate understanding of the significant ground and flight risks involved.

  11. Willingness to pay for private and public road safety in stated preference studies: why the difference?

    PubMed

    Svensson, Mikael; Vredin Johansson, Maria

    2010-07-01

    Estimates of the willingness to pay (WTP) for a mortality risk reduction can be used to calculate the value of a statistical life, which is a major component in many economic evaluations of environmental and safety policies. Previous research on the WTP for risk reductions using stated preference methods have found that the mean WTP for public risk reductions is significantly smaller compared to the mean WTP for private risk reductions of equal magnitude. Hence, the use of a private or public scenario in stated preference studies of e.g. environmental or safety policies may strongly determine the outcome of the economic evaluation. In this paper we use a stated preference survey to show that WTP for a private risk reduction is three times higher compared to a public risk reduction and a significant part of the difference can be explained by respondents' attitudes towards privately and publicly provided goods in general.

  12. Field studies of safety security rescue technologies through training and response activities

    NASA Astrophysics Data System (ADS)

    Murphy, Robin R.; Stover, Sam

    2006-05-01

    This paper describes the field-oriented philosophy of the Institute for Safety Security Rescue Technology (iSSRT) and summarizes the activities and lessons learned during calendar year 2005 of its two centers: the Center for Robot-Assisted Search and Rescue and the NSF Safety Security Rescue industry/university cooperative research center. In 2005, iSSRT participated in four responses (La Conchita, CA, Mudslides, Hurricane Dennis, Hurricane Katrina, Hurricane Wilma) and conducted three field experiments (NJTF-1, Camp Hurricane, Richmond, MO). The lessons learned covered mobility, operator control units, wireless communications, and general reliability. The work has collectively identified six emerging issues for future work. Based on these studies, a 10-hour, 1 continuing education unit credit course on rescue robotics has been created and is available. Rescue robots and sensors are available for loan upon request.

  13. Probabilistic Safety Study Applications Program for inspection of the Indian Point Unit 3 Nuclear Power Plant

    SciTech Connect

    Taylor, J.H.; Fullwood, R.; Fresco, A.

    1986-03-01

    By prioritizing the various areas of interest for inspection and by better defining inspection needs, the NRC expects to make more effective use of finite inspection resources by concentrating on those potential areas most significant to safety. Through review and application of the Indian Point Unit 3 Probabilistic Safety Study's numerical data and event tree modeling, and by utilizing related documents, a technical basis for prioritizing areas for NRC inspection has been developed. This was then tested at the plant site for the NRC Operating Reactor Inspection Program, I and E Manual Chapter 2515. Inspection activities addressed include normal operations, system and component testing, maintenance and surveillance. A computer program entitled NSPKTR, which was developed specifically for this program, modeled the internal plant states to the system level and performed the risk and importance calculations. 17 refs., 21 tabs.

  14. Evaluation of the benefits of vehicle safety technology: the MUNDS study.

    PubMed

    Fildes, Brian; Keall, Michael; Thomas, Pete; Parkkari, Kalle; Pennisi, Lucia; Tingvall, Claes

    2013-06-01

    Real-world retrospective evaluation of the safety benefits of new integrated safety technologies is hampered by the lack of sufficient data to assess early reliable benefits. This MUNDS study set out to examine if a "prospective" case-control meta-analysis had the potential to provide more rapid and rigorous analyses of vehicle and infrastructure safety improvements. To examine the validity of the approach, an analysis of the effectiveness of ESC using a consistent analytic strategy across 6 European and Australasian databases was undertaken. It was hypothesised that the approach would be valid if the results of the MUNDS analysis were consistent with those published earlier (this would confirm the suitability of the MUNDS approach). The findings confirm the hypothesis and also found stronger and more robust findings across the range of crash-types, road conditions, vehicle sizes and speed zones than previous. The study recommends that while a number of limitations were identified with the findings that need be addressed in future research, the MUNDS approach nevertheless should be adopted widely for the benefit of all vehicle occupants.

  15. Health, safety and environmental unit performance assessment model under uncertainty (case study: steel industry).

    PubMed

    Shamaii, Azin; Omidvari, Manouchehr; Lotfi, Farhad Hosseinzadeh

    2017-01-01

    Performance assessment is a critical objective of management systems. As a result of the non-deterministic and qualitative nature of performance indicators, assessments are likely to be influenced by evaluators' personal judgments. Furthermore, in developing countries, performance assessments by the Health, Safety and Environment (HSE) department are based solely on the number of accidents. A questionnaire is used to conduct the study in one of the largest steel production companies in Iran. With respect to health, safety, and environment, the results revealed that control of disease, fire hazards, and air pollution are of paramount importance, with coefficients of 0.057, 0.062, and 0.054, respectively. Furthermore, health and environment indicators were found to be the most common causes of poor performance. Finally, it was shown that HSE management systems can affect the majority of performance safety indicators in the short run, whereas health and environment indicators require longer periods of time. The objective of this study is to present an HSE-MS unit performance assessment model in steel industries. Moreover, we seek to answer the following question: what are the factors that affect HSE unit system in the steel industry? Also, for each factor, the extent of impact on the performance of the HSE management system in the organization is determined.

  16. A Case Study of Dynamic Response Analysis and Safety Assessment for a Suspended Monorail System

    PubMed Central

    Bao, Yulong; Li, Yongle; Ding, Jiajie

    2016-01-01

    A suspended monorail transit system is a category of urban rail transit, which is effective in alleviating traffic pressure and injury prevention. Meanwhile, with the advantages of low cost and short construction time, suspended monorail transit systems show vast potential for future development. However, the suspended monorail has not been systematically studied in China, and there is a lack of relevant knowledge and analytical methods. To ensure the health and reliability of a suspended monorail transit system, the driving safety of vehicles and structure dynamic behaviors when vehicles are running on the bridge should be analyzed and evaluated. Based on the method of vehicle-bridge coupling vibration theory, the finite element method (FEM) software ANSYS and multi-body dynamics software SIMPACK are adopted respectively to establish the finite element model for bridge and the multi-body vehicle. A co-simulation method is employed to investigate the vehicle-bridge coupling vibration for the transit system. The traffic operation factors, including train formation, track irregularity and tire stiffness, are incorporated into the models separately to analyze the bridge and vehicle responses. The results show that the coupling of dynamic effects of the suspended monorail system between vehicle and bridge are significant in the case studied, and it is strongly suggested to take necessary measures for vibration suppression. The simulation of track irregularity is a critical factor for its vibration safety, and the track irregularity of A-level road roughness negatively influences the system vibration safety. PMID:27834923

  17. A Case Study of Dynamic Response Analysis and Safety Assessment for a Suspended Monorail System.

    PubMed

    Bao, Yulong; Li, Yongle; Ding, Jiajie

    2016-11-10

    A suspended monorail transit system is a category of urban rail transit, which is effective in alleviating traffic pressure and injury prevention. Meanwhile, with the advantages of low cost and short construction time, suspended monorail transit systems show vast potential for future development. However, the suspended monorail has not been systematically studied in China, and there is a lack of relevant knowledge and analytical methods. To ensure the health and reliability of a suspended monorail transit system, the driving safety of vehicles and structure dynamic behaviors when vehicles are running on the bridge should be analyzed and evaluated. Based on the method of vehicle-bridge coupling vibration theory, the finite element method (FEM) software ANSYS and multi-body dynamics software SIMPACK are adopted respectively to establish the finite element model for bridge and the multi-body vehicle. A co-simulation method is employed to investigate the vehicle-bridge coupling vibration for the transit system. The traffic operation factors, including train formation, track irregularity and tire stiffness, are incorporated into the models separately to analyze the bridge and vehicle responses. The results show that the coupling of dynamic effects of the suspended monorail system between vehicle and bridge are significant in the case studied, and it is strongly suggested to take necessary measures for vibration suppression. The simulation of track irregularity is a critical factor for its vibration safety, and the track irregularity of A-level road roughness negatively influences the system vibration safety.

  18. SiO2 aerosol nanoparticle reactor for occupational health and safety studies.

    PubMed

    Ostraat, Michele L; Swain, Keith A; Krajewski, James J

    2008-06-01

    Important questions are emerging about potential occupational safety, toxicological, and ecotoxicological effects and occupational inhalation exposure risks to engineered aerosol nanoparticles. Although multiple avenues are available to synthesize nanoparticles, few tools are accessible to industrial hygienists and inhalation toxicologists to produce well-characterized aerosols of known aerosol size distribution and particle number concentration that are stable, simple, and robust to operate. This article describes a SiO(2) aerosol nanoparticle reactor that has been developed as a tool for the study of the safety, health, and environmental consequences of exposure to nanoparticle synthesis and processing. The SiO(2) aerosol nanoparticle reactor is capable of stable, long-term synthesis of amorphous SiO(2) aerosol nanoparticles from d(50) = 10-70 nm at particle concentrations approximately 10(4)-10(7)particles/cm(3) that does not produce halogen-containing byproducts and does not require daily monitoring of the particle size distribution. This reactor is designed to produce a well-characterized aerosol to enable subsequent testing with a continuous, stable supply of aerosol nanoparticles (i) to facilitate inhalation toxicology studies, (ii) to measure explosion characteristics of aerosol nanoparticles, (iii) to determine the barrier efficacy for respirator filtration, bag house exhaust, and personal protective garment media challenged with diverse aerosol nanoparticles, and (iv) to develop airborne monitoring technologies for verifying workplace safety protocols. This article details reactor design, synthesis parameters, and instruments available to characterize the resulting aerosol nanoparticle size distributions.

  19. Safety of gadoxetate disodium: results from six clinical phase IV studies in 8194 patients

    PubMed Central

    Kim, So Yeon; Sakaguchi, Toshiaki; Dohanish, Susan; Breuer, Josy

    2015-01-01

    Background Safety data on routine clinical use of gadoxetate disodium for liver magnetic resonance imaging (MRI) is not reported yet. Purpose To assess the safety profile of gadoxetate disodium for liver MRI in the routine clinical setting. Material and Methods Six multicenter studies were performed in Europe, USA, Australia, and Asia to evaluate the safety and efficacy of gadoxetate disodium (Primovist®/Eovist®) enhanced liver MRI. Patients received a single intravenous bolus injection of the standard approved dose of 0.025 mmol/kg body weight (0.1 mL/kg). The number of patients, the characteristics of adverse events, related adverse events, and serious adverse events were analyzed. Results A total of 8194 patients were included in the database. A total of 141 patients (1.7%) reported 230 AEs of which 129 were considered being related to the use of gadoxetate disodium by the investigators. None of the AEs in the pediatric population (n = 52) were related. The most frequent AEs independent of relationship to the drug included dyspnea (25/0.31%), nausea (22/0.27%), liver disorders (13/0.16%), and renal disorders (9/0.11%). Nine related SAEs were recorded. No patient died during the studies. Conclusion Gadoxetate disodium for liver MRI is safe and well tolerated in the routine clinical setting. PMID:26048848

  20. Feasibility of a hemodialysis safety checklist for nurses and patients: a quality improvement study

    PubMed Central

    Thomas, Alison; Silver, Samuel A.; Rathe, Andrea; Robinson, Pamela; Wald, Ron; Bell, Chaim M.; Harel, Ziv

    2016-01-01

    Background Patients with end-stage renal disease are at high risk for medical errors given their comorbidities, polypharmacy and coordination of care with other hospital departments. We previously developed a hemodialysis safety checklist (Hemo Pause) to be jointly completed by nurses and patients. Our objective was to determine the feasibility of using this checklist during every hemodialysis session for 3 months. Methods We conducted a single-center, prospective time series study. A convenience sample of 14 nurses and 22 prevalent in-center hemodialysis patients volunteered to participate. All participants were trained in the administration of the Hemo Pause checklist. The primary outcome was completion of the Hemo Pause checklist, which was assessed at weekly intervals. We also measured the acceptability of the Hemo Pause checklist using a local patient safety survey. Results There were 799 hemodialysis treatments pre-intervention (13 January–5 April 2014) and 757 post-intervention (5 May–26 July 2014). The checklist was completed for 556 of the 757 (73%) treatments. Among the hemodialysis nurses, 93% (13/14) agreed that the checklist was easy to use and 79% (11/14) agreed it should be expanded to other patients. Among the hemodialysis patients, 73% (16/22) agreed that the checklist made them feel safer and should be expanded to other patients. Conclusions The Hemo Pause safety checklist was acceptable to both nurses and patients over 3 months. Our next step is to spread this checklist locally and conduct a mixed methods study to determine mechanisms by which its use may improve safety culture and reduce adverse events. PMID:27274816

  1. Systemic exposure to the metabolites of lesogaberan in humans and animals: a case study of metabolites in safety testing.

    PubMed

    Holmberg, Ann Aurell; Ekdahl, Anja; Weidolf, Lars

    2014-06-01

    During preclinical and early phase clinical studies of drug candidates, exposure to metabolites should be monitored to determine whether safety conclusions drawn from studies in animals can be extrapolated to humans. Metabolites accounting for more than 10% of total exposure to drug-related material (DRM) in humans are of regulatory concern, and for any such metabolites, adequate exposure should be demonstrated in animals before large-scale phase 3 clinical trials are conducted. We have previously identified six metabolites, M1-M6, of the gastroesophageal reflux inhibitor lesogaberan. In this study, we measured exposure in humans, rats, and beagle dogs to lesogaberan and these metabolites. Plasma samples were taken at various time points after lesogaberan dosing in two clinical and three preclinical studies. Concentrations of lesogaberan and its metabolites were measured, and exposures during a single dosing interval were calculated. The parent compound and metabolites M1, M2, M4, and M5 were together shown to constitute all significant exposure to DRM in humans. Only M4 and M5 were present at levels of regulatory concern (10.6% and 18.9% of total exposure to DRM, respectively, at steady state). Absolute exposure to M5 was greater in rats during toxicology studies than the highest absolute exposure observed in humans at steady state (117.0 µmol × h/liter vs. 52.2 µmol × h/liter). In contrast, exposure to M4 in rats was less than 50% of the highest absolute exposure observed in humans. Further safety testing of this metabolite may therefore be required.

  2. Further study of the intrinsic safety of internally shorted lithium and lithium-ion cells within methane-air

    PubMed Central

    Dubaniewicz, Thomas H.; DuCarme, Joseph P.

    2015-01-01

    National Institute for Occupational Safety and Health (NIOSH) researchers continue to study the potential for lithium and lithium-ion battery thermal runaway from an internal short circuit in equipment for use in underground coal mines. Researchers conducted cell crush tests using a plastic wedge within a 20-L explosion-containment chamber filled with 6.5% CH4-air to simulate the mining hazard. The present work extends earlier findings to include a study of LiFePO4 cells crushed while under charge, prismatic form factor LiCoO2 cells, primary spiral-wound constructed LiMnO2 cells, and crush speed influence on thermal runaway susceptibility. The plastic wedge crush was a more severe test than the flat plate crush with a prismatic format cell. Test results indicate that prismatic Saft MP 174565 LiCoO2 and primary spiral-wound Saft FRIWO M52EX LiMnO2 cells pose a CH4-air ignition hazard from internal short circuit. Under specified test conditions, A123 systems ANR26650M1A LiFePO4 cylindrical cells produced no chamber ignitions while under a charge of up to 5 A. Common spiral-wound cell separators are too thin to meet intrinsic safety standards provisions for distance through solid insulation, suggesting that a hard internal short circuit within these cells should be considered for intrinsic safety evaluation purposes, even as a non-countable fault. Observed flames from a LiMnO2 spiral-wound cell after a chamber ignition within an inert atmosphere indicate a sustained exothermic reaction within the cell. The influence of crush speed on ignitions under specified test conditions was not statistically significant. PMID:26139958

  3. Efficacy and safety of atorvastatin in hyperlipidemic, type 2 diabetic patients. A 34-week, multicenter, open-label study.

    PubMed

    Aguilar-Salinas, C A; Gómez-Pérez, F J; Posadas-Romero, C; Vázquez-Chávez, C; Meaney, E; Gulías-Herrero, A; Guillén, L E; Alvarado Vega, A; Mendoza Pérez, E; Eduardo Romero-Nava, L; Angélica Gómez-Díaz, R; Salinas-Orozco, S; Moguel, R; Novoa, G

    2000-10-01

    Hyperlipidemia is common in type 2 diabetic patients and is an independent risk factor for cardiovascular disease. The aim of this trial was to evaluate the efficacy and safety of once-daily atorvastatin 10-80 mg for the treatment of hyperlipidemia in type 2 diabetics with plasma low-density lipoprotein cholesterol (LDL-C) levels exceeding 3.4 mmol/l (130 mg/dl). One hundred and two patients met the study criteria and received 10 mg/day atorvastatin. Patients who reached the target LDL-C level of study attained target LDL-C levels and 52 (59%) of patients achieved the target goal at the starting dose of atorvastatin 10 mg/day. In this group the differences between baseline and post-treatment values for LDL-C were 4.3+/-0.7 mmol/l (166+/-26 mg/dl) versus 2. 2+/-0.4 mmol/l (87+/-14 mg/dl) (P<0.0001), respectively, a decrease of 47%. Similar trends were observed for total cholesterol, triglycerides, very low-density lipoprotein cholesterol and apolipoprotein B levels. The safety profile of atorvastatin in these patients was highly favorable and similar to those reported with other statins. Only one patient withdrew due to a possible drug-related adverse event. These data confirm the marked efficacy and safety of atorvastatin in type 2 diabetic patients with hyperlipidemia and the efficacy of atorvastatin 10 mg in helping patients attain their LDL-C goal.

  4. Prolonged-release melatonin for insomnia – an open-label long-term study of efficacy, safety, and withdrawal

    PubMed Central

    Lemoine, Patrick; Garfinkel, Doron; Laudon, Moshe; Nir, Tali; Zisapel, Nava

    2011-01-01

    Background Prolonged-release melatonin (PRM) 2 mg is indicated for insomnia in patients aged 55 years and older. A recent double-blind placebo-controlled study demonstrated 6-month efficacy and safety of PRM in insomnia patients aged 18–80 and lack of withdrawal and rebound symptoms upon discontinuation. Objective To investigate the efficacy, safety, and withdrawal phenomena associated with 6–12 months PRM treatment. Methods Data from a prospective 6–12-month open-label study of 244 community dwelling adults with primary insomnia, who had participated in a placebo-controlled, double-blind dose-ranging trial of PRM. Patients received PRM nightly, followed by a 2-week withdrawal period. Main outcome measures were patient-reported sleep quality ratings (diary), adverse events, vital signs, and laboratory tests recorded at each visit, and withdrawal symptoms (CHESS-84 [Check-list Evaluation of Somatic Symptoms]). Nocturnal urinary 6-sulfatoxymelatonin excretion, a measure of the endogenous melatonin production, was assessed upon discontinuing long-term PRM. Results Of the 244 patients, 36 dropped out, 112 completed 6 months of treatment, and the other 96 completed 12 months of treatment. The mean number of nights by which patients reported sleep quality as “good” or “very good” was significantly higher during PRM than before treatment. There was no evidence of tolerance to PRM. Discontinuation of PRM was not associated with rebound insomnia or withdrawal symptoms; on the contrary, residual benefit was observed. PRM was well tolerated, and there was no suppression of endogenous melatonin production. Conclusion Results support the efficacy and safety of PRM in primary insomnia patients aged 20–80 throughout 6–12 months of continuous therapy. PRM discontinuation even after 12 months was not associated with adverse events, withdrawal symptoms, or suppression of endogenous melatonin production. PMID:21845053

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

    NASA Technical Reports Server (NTRS)

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

    1987-01-01

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

  6. The range of replications technique for assessing the external validity of road safety evaluation studies.

    PubMed

    Elvik, Rune

    2012-03-01

    This paper introduces a simple statistical technique that can be used to assess the external validity of road safety evaluation studies. External validity refers to the possibility of generalising the results of research to other contexts than those in which it was made. There are several aspects of external validity. Two aspects that are often of interest concern the applicability of the results of road safety evaluation studies across countries and time. Can the results of studies made in one or more countries be applied in countries where studies have not been made? Can the results of studies made many years ago still be applied? The technique introduced in this paper is designed to provide support in answering these questions. The technique evaluates the stability of research results in time and space. The technique is based on cumulative meta-analysis and produces statistics that show the consistency of study results in time and space (across countries). The range of replications denotes the span of time and countries in which studies have been made. The idea is that if the results of studies are stable throughout the range of replications, one may have greater confidence in their external validity than if the results of research vary in time and between countries. The technique is illustrated by means of numerical examples.

  7. An escalating dose study to assess the safety, tolerability and immunogenicity of a Herpes Simplex Virus DNA vaccine, COR-1

    PubMed Central

    Dutton, Julie L.; Woo, Wai-Ping; Chandra, Janin; Xu, Yan; Li, Bo; Finlayson, Neil; Griffin, Paul; Frazer, Ian H.

    2016-01-01

    ABSTRACT This paper describes a single site, open-label Phase I clinical trial evaluating the safety, tolerability and immunogenicity in healthy volunteers of a herpes simplex polynucleotide vaccine that has previously been shown to enhance immunogenicity and protect against lethal herpes simplex virus type 2 (HSV-2) challenge in mice. Five escalating doses of the vaccine, COR-1, were given by intradermal injection to HSV-1 and 2 seronegative healthy individuals. COR-1 was found to be safe and well-tolerated; the only vaccine-related adverse events were mild. While vaccine-induced antibody responses were not detectable, cell-mediated immune responses to HSV-specific peptide groups were identified in 19 of the 20 subjects who completed the study, and local inflammation at the immunisation site was observed. This study indicates COR-1 has potential to be used as a therapeutic vaccine for HSV-2 infection. PMID:27580249

  8. An Open-Label Extension Study of the Safety and Efficacy of Risperidone in Children and Adolescents with Autistic Disorder

    PubMed Central

    Hough, David; Singh, Jaskaran; Karcher, Keith; Pandina, Gahan

    2013-01-01

    Abstract Objective: The purpose of this study was to evaluate the long-term safety and efficacy of risperidone in treating irritability and related behaviors in children and adolescents with autistic disorders. Methods: In this 6 month (26 week) open-label extension (OLE) study, patients (5–17 years of age, who completed the previous fixed-dose, 6 week, double-blind [DB] phase) were flexibly dosed with risperidone based on body weight. The maximum allowed dose was 1.25 mg/day for those weighing 20 to <45 kg, and 1.75 mg/day for those weighing ≥45 kg. The study primarily assessed risperidone's safety; efficacy was assessed as a secondary end-point. Results: Fifty-six (71%) out of 79 enrolled patients completed the OLE; the most common discontinuations were for insufficient response (7 [9%]) or adverse events (AE) (5 [6%]). The most common (≥5% frequency in the total group) AEs were increased appetite (11% [n=9]); increased weight and vomiting (9% [n=7] each); sedation, pyrexia, and upper respiratory tract infection (8% [n=6] each); nasopharyngitis (6% [n=5]); and somnolence and fatigue (5% [n=4] each). Extrapyramidal AEs were reported in 6 (8%) patients. Increase in mean weight (11–15%) and body mass index (5–10%) occurred; one patient discontinued because of weight increase. One potentially prolactin-related AE (irregular menstruation) was reported. The risperidone high-dose group had the greatest mean improvement in sleep visual analog scale (24.6). All groups showed additional improvement in efficacy scale scores during the OLE. Conclusions: During this OLE, safety findings with risperidone treatment (maximum weight-based dose of 1.25 mg/day or 1.75 mg/day) were consistent with those observed in the DB phase, and with the current safety information for risperidone in autistic, psychiatric, and behavioral disorders. Patients experienced some additional improvement in irritability and related behaviors. Clinical Trials Registry: This phase-4

  9. Folic Acid Supplementation and Preterm Birth: Results from Observational Studies

    PubMed Central

    Franchi, Massimo

    2014-01-01

    Introduction. Folic acid (FA) supplementation is recommended worldwide in the periconceptional period for the prevention of neural tube defects. Due to its involvement in a number of cellular processes, its role in other pregnancy outcomes such as miscarriage, recurrent miscarriage, low birth weight, preterm birth (PTB), preeclampsia, abruptio placentae, and stillbirth has been investigated. PTB is a leading cause of perinatal mortality and morbidity; therefore its association with FA supplementation is of major interest. The analysis of a small number of randomized clinical trials (RCTs) has not found a beneficial role of FA in reducing the rate of PTBs. Aim of the Study. The aim of this review was to examine the results from recent observational studies about the effect of FA supplementation on PTB. Materials and Methods. We carried out a search on Medline and by manual search of the observational studies from 2009 onwards that analyzed the rate of PTB in patients who received supplementation with FA before and/or throughout pregnancy. Results. The results from recent observational studies suggest a slight reduction of PTBs that is not consistent with the results from RCTs. Further research is needed to better understand the role of FA supplementation before and during pregnancy in PTB. PMID:24724083

  10. Statistical study of seismo-electromagnetic effects observed by DEMETER

    NASA Astrophysics Data System (ADS)

    Nemec, F.; Santolik, O.; Parrot, M.; Berthelier, J.

    2006-12-01

    We present results of a statistical study of VLF electromagnetic waves observed in the vicinity of earthquakes. Survey mode data obtained by the French micro-satellite DEMETER (launched in June, 2004, inclination ~98 degrees, altitude ~700 km, designed specifically to analyze seismo-electromagnetic emissions) are used. Altogether, more than 5000 hours of data and more than 4500 earthquakes that occurred in the satellite zone are analyzed. A robust two-step data processing method has been developed and applied in order to distinguish very weak phenomena connected with the seismic activity from the natural background. In the first step, a map in the form of a histogram expressing the expected values of intensity of electromagnetic emissions at a given point of the satellite orbit under given conditions is constructed. In the second step, the intensity of emissions measured close to the earthquakes is compared with the distribution of intensities that could be expected from the previous step. Statistical consequences of the described data processing are thoroughly discussed and it is concluded that the observed fluctuations of wave intensity are most probably connected to the earthquakes. The frequency spectrum of the observed emissions, shape and dimensions of the affected area, as well as the most favorable natural conditions and earthquake properties to observe the phenomenon are studied.

  11. Safety of desirudin in thrombosis prevention after total knee arthroplasty: the DESIR-ABLE study.

    PubMed

    Jove, Maurice; Maslanka, Marc; Minkowitz, Harold S; Jaffer, Amir K

    2014-01-01

    Desirudin, administered 30 minutes before total hip arthroplasty is superior to enoxaparin in preventing proximal deep vein thrombosis (DVT) and pulmonary embolism (PE) with similar bleeding. The purpose of this study was to determine the safety of desirudin in patients undergoing elective total knee arthroplasty (TKA) when the first dose of desirudin was administered the evening after surgery. This is a case series of patients undergoing TKA who received desirudin 15 mg every 12 hours subcutaneously for an average of 5 days with the first dose administered postoperatively. The primary endpoint was major bleeding; secondary endpoints included wound outcomes (oozing and infection) and new symptomatic DVT or PE. Desirudin has a favorable safety profile when administered postoperatively in patients undergoing TKA with no reports of major bleeding, wound ooze, or infection. No patients experienced symptomatic DVT, but 2 patients had PE detected by computed tomography after experiencing atypical symptoms. The safety profile of desirudin is improved when administered postoperatively. Bleeding and wound outcomes seem to occur less frequently than historical desirudin and enoxaparin controls.

  12. Preclosure radiological safety evaluation: Exploratory Studies Facility; Yucca Mountain Site Characterization Project

    SciTech Connect

    Schelling, F.J.; Smith, J.D.

    1993-07-01

    A radiological safety evaluation is performed to determine the impacts of Exploratory Studies Facility (ESF) design changes on the preclosure public radiological safety for a potential nuclear waste repository at Yucca Mountain, Nevada. Although the ESF design has undergone significant modification, incorporation of the modified design requires only modest changes to the conceptual repository configuration. To the extent feasible, the results of earlier safety evaluations presented in SAND84-2641, SAND88-7061, and SAND89-7024, which were based on the original ESF configuration, are compared with the results for the modified configuration. This comparison provides an estimate of the range of analysis uncertainty. This preliminary analysis indicates that there are no Q-scenarios, which are defined as those scenarios with a net occurrence probability of greater than 10{sup {minus}6}/yr and produce a radiological dose at the 5-km controlled area boundary of greater than 0.5 rem. The analysis yielded estimates for an underground accident of a probability of 3.8 {times} 10{sup {minus}15}/yr and a dose of 1.5 rem. For a surface-initiated accident, a probability of 1.5 {times} 10{sup {minus}12}/yr and a dose of 0.6 rem was estimated.

  13. Reasons for not reporting patient safety incidents in general practice: A qualitative study

    PubMed Central

    Kousgaard, Marius Brostrøm; Joensen, Anne Sofie; Thorsen, Thorkil

    2012-01-01

    Objective To explore the reasons for not reporting patient safety incidents in general practice. Design Qualitative interviews with general practitioners and members of the project group. Setting General practice clinics in the Region of Northern Jutland in Denmark. Subjects Twelve general practitioners. Main outcome measures The experiences and reflections of the involved professionals with regard to system use and non-use. Results While most respondents were initially positive towards the idea of reporting and learning from patient safety incidents, they actually reported very few incidents. The major reasons for the low reporting rates are found to be a perceived lack of practical usefulness, issues of time and effort in a busy clinic with competing priorities, and considerations of appropriateness in relation to other professionals. Conclusion The results suggest that the visions of formal, comprehensive, and systematic reporting of (and learning from) patient safety incidents will be quite difficult to realize in general practice. Future studies should investigate how various ways of organizing incident reporting at the regional level influence local activities of reporting and learning in general practice. PMID:23113662

  14. Assuring consumer safety without animal testing: a feasibility case study for skin sensitisation.

    PubMed

    Maxwell, Gavin; Aleksic, Maja; Aptula, Aynur; Carmichael, Paul; Fentem, Julia; Gilmour, Nicola; Mackay, Cameron; Pease, Camilla; Pendlington, Ruth; Reynolds, Fiona; Scott, Daniel; Warner, Guy; Westmoreland, Carl

    2008-11-01

    Allergic Contact Dermatitis (ACD; chemical-induced skin sensitisation) represents a key consumer safety endpoint for the cosmetics industry. At present, animal tests (predominantly the mouse Local Lymph Node Assay) are used to generate skin sensitisation hazard data for use in consumer safety risk assessments. An animal testing ban on chemicals to be used in cosmetics will come into effect in the European Union (EU) from March 2009. This animal testing ban is also linked to an EU marketing ban on products containing any ingredients that have been subsequently tested in animals, from March 2009 or March 2013, depending on the toxicological endpoint of concern. Consequently, the testing of cosmetic ingredients in animals for their potential to induce skin sensitisation will be subject to an EU marketing ban, from March 2013 onwards. Our conceptual framework and strategy to deliver a non-animal approach to consumer safety risk assessment can be summarised as an evaluation of new technologies (e.g. 'omics', informatics), leading to the development of new non-animal (in silico and in vitro) predictive models for the generation and interpretation of new forms of hazard characterisation data, followed by the development of new risk assessment approaches to integrate these new forms of data and information in the context of human exposure. Following the principles of the conceptual framework, we have been investigating existing and developing new technologies, models and approaches, in order to explore the feasibility of delivering consumer safety risk assessment decisions in the absence of new animal data. We present here our progress in implementing this conceptual framework, with the skin sensitisation endpoint used as a case study.

  15. Safety Risk Knowledge Elicitation in Support of Aeronautical R and D Portfolio Management: A Case Study

    NASA Technical Reports Server (NTRS)

    Shih, Ann T.; Ancel, Ersin; Jones, Sharon Monica; Reveley, Mary S.; Luxhoj, James T.

    2012-01-01

    Aviation is a problem domain characterized by a high level of system complexity and uncertainty. Safety risk analysis in such a domain is especially challenging given the multitude of operations and diverse stakeholders. The Federal Aviation Administration (FAA) projects that by 2025 air traffic will increase by more than 50 percent with 1.1 billion passengers a year and more than 85,000 flights every 24 hours contributing to further delays and congestion in the sky (Circelli, 2011). This increased system complexity necessitates the application of structured safety risk analysis methods to understand and eliminate where possible, reduce, and/or mitigate risk factors. The use of expert judgments for probabilistic safety analysis in such a complex domain is necessary especially when evaluating the projected impact of future technologies, capabilities, and procedures for which current operational data may be scarce. Management of an R&D product portfolio in such a dynamic domain needs a systematic process to elicit these expert judgments, process modeling results, perform sensitivity analyses, and efficiently communicate the modeling results to decision makers. In this paper a case study focusing on the application of an R&D portfolio of aeronautical products intended to mitigate aircraft Loss of Control (LOC) accidents is presented. In particular, the knowledge elicitation process with three subject matter experts who contributed to the safety risk model is emphasized. The application and refinement of a verbal-numerical scale for conditional probability elicitation in a Bayesian Belief Network (BBN) is discussed. The preliminary findings from this initial step of a three-part elicitation are important to project management practitioners as they illustrate the vital contribution of systematic knowledge elicitation in complex domains.

  16. Theoretical and Observational Studies of Meteor Interactions with the Ionosphere

    DTIC Science & Technology

    2006-06-01

    Spaceborne Ultraviolet 251-384 nm Spectroscopy of a Meteor During the 1997 Leonid Shower , Meteorites and Planetary Science, 37. Jones, W., 1997...RTO-MP-IST-056 12 - 1 UNCLASSIFIED/UNLIMITED UNCLASSIFIED/UNLIMITED Theoretical and Observational Studies of Meteor Interactions with the...ABSTRACT An intense flux of small-mass meteors has been seen in large-aperture radar scattering for many years. At high altitudes, these meteoroids

  17. Strategies GeoCape Intelligent Observation Studies @ GSFC

    NASA Technical Reports Server (NTRS)

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

    2015-01-01

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

  18. The role of the Data and Safety Monitoring Board in a clinical trial: The CRISIS Study

    PubMed Central

    Holubkov, Richard; Casper, T. Charles; Dean, J. Michael; Anand, K. J. S.; Zimmerman, Jerry; Meert, Kathleen L.; Newth, Christopher J. L.; Berger, John; Harrison, Rick; Willson, Douglas F.; Nicholson, Carol

    2012-01-01

    Objective Randomized clinical trials are commonly overseen by a data and safety monitoring board (DSMB) comprised of experts in medicine, ethics, and biostatistics. DSMB responsibilities include protocol approval, interim review of study enrollment, protocol compliance, safety, and efficacy data. DSMB decisions can affect study design and conduct, as well as reported findings. Researchers must incorporate DSMB oversight into the design, monitoring, and reporting of randomized trials. Design Case study, narrative review. Methods The DSMB’s role during the comparative pediatric Critical Illness Stress-Induced Immune Suppression (CRISIS) Prevention Trial is described. Findings The NIH-appointed CRISIS DSMB was charged with monitoring sample size adequacy and feasibility, safety with respect to adverse events and 28-day mortality, and efficacy with respect to the primary nosocomial infection/sepsis outcome. The Federal Drug Administration also requested DSMB interim review before opening CRISIS to children below one year of age. The first interim analysis found higher 28-day mortality in one treatment arm. The DSMB maintained trial closure to younger children, and requested a second interim data review six months later. At this second meeting, mortality was no longer of concern, while a weak efficacy trend of lower infection/sepsis rates in one study arm emerged. As over 40% of total patients had been enrolled, the DSMB elected to examine conditional power, and unmask treatment arm identities. Upon finding somewhat greater efficacy in the placebo arm, the DSMB recommended stopping CRISIS due to futility. Conclusions The design and operating procedures of a multicenter randomized trial must consider a pivotal DSMB role. Maximum study design flexibility must be allowed, and investigators must be prepared for protocol modifications due to interim findings. The DSMB must have sufficient clinical and statistical expertise to assess potential importance of interim

  19. A Comparative Study of Cloud Observation between Instrumental Measurements and Visual Observations

    NASA Astrophysics Data System (ADS)

    Park, Y. S.; Jeong, J. Y.; Park, D. O.; Kang, J. J.; Choi, B. C.

    2014-12-01

    The microphysical observations of clouds have been performed by human observers who record the amount, height, and type of cloud. However, the observational methods of clouds by human observers have their limitations due to its difficulties in the punctuality and weakness of assessment. The Automatic Cloud Observation System(ACOS) has been developed by NIMR to obtain continuous informationof the amount and height of clouds. A set of ACOS is composed of two cameras and the amounts and heights of clouds are retrieved from the sky images. Four sets of the ACOS were installed during last 4 years at four locations in South Korea. They are compared with cloud observation data from visual observations and instrumental measurements using ceilometers, radiometers, and another camera-type instrument named "Sky View". Recent two-year observation data are analyzed, focused on the differences of cloud amounts and heights between cloud observation methods.

  20. Targeted Maximum Likelihood Estimation for Causal Inference in Observational Studies.

    PubMed

    Schuler, Megan S; Rose, Sherri

    2017-01-01

    Estimation of causal effects using observational data continues to grow in popularity in the epidemiologic literature. While many applications of causal effect estimation use propensity score methods or G-computation, targeted maximum likelihood estimation (TMLE) is a well-established alternative method with desirable statistical properties. TMLE is a doubly robust maximum-likelihood-based approach that includes a secondary "targeting" step that optimizes the bias-variance tradeoff for the target parameter. Under standard causal assumptions, estimates can be interpreted as causal effects. Because TMLE has not been as widely implemented in epidemiologic research, we aim to provide an accessible presentation of TMLE for applied researchers. We give step-by-step instructions for using TMLE to estimate the average treatment effect in the context of an observational study. We discuss conceptual similarities and differences between TMLE and 2 common estimation approaches (G-computation and inverse probability weighting) and present findings on their relative performance using simulated data. Our simulation study compares methods under parametric regression misspecification; our results highlight TMLE's property of double robustness. Additionally, we discuss best practices for TMLE implementation, particularly the use of ensembled machine learning algorithms. Our simulation study demonstrates all methods using super learning, highlighting that incorporation of machine learning may outperform parametric regression in observational data settings.

  1. Safety of inhaled glycopyrronium in patients with COPD: a comprehensive analysis of clinical studies and post-marketing data

    PubMed Central

    D’Urzo, Anthony D; Kerwin, Edward M; Chapman, Kenneth R; Decramer, Marc; DiGiovanni, Robert; D’Andrea, Peter; Hu, Huilin; Goyal, Pankaj; Altman, Pablo

    2015-01-01

    Background Chronic use of inhaled anticholinergics by patients with chronic obstructive pulmonary disease (COPD) has raised long-term safety concerns, particularly cardiovascular. Glycopyrronium is a once-daily anticholinergic with greater receptor selectivity than previously available agents. Methods We assessed the safety of inhaled glycopyrronium using data pooled from two analysis sets, involving six clinical studies and over 4,000 patients with COPD who received one of the following treatments: glycopyrronium 50μg, placebo (both delivered via the Breezhaler® device), or tiotropium 18 μg (delivered via the HandiHaler® device). Data were pooled from studies that varied in their duration and severity of COPD of the patients (ie, ≤12 weeks duration with patients having moderate or severe COPD; and >1 year duration with patients having severe and very severe COPD). Safety comparisons were made for glycopyrronium vs tiotropium or placebo. Poisson regression was used to assess the relative risk for either active drug or placebo (and between drugs where placebo was not available) for assessing the incidence of safety events. During post-marketing surveillance (PMS), safety was assessed by obtaining reports from various sources, and disproportionality scores were computed using EMPIRICA™. In particular, the cardiac safety of glycopyrronium during the post-marketing phase was evaluated. Results The overall incidence of adverse events and deaths was similar across groups, while the incidence of serious adverse events was numerically higher in placebo. Furthermore, glycopyrronium did not result in an increased risk of cerebro-cardiovascular events vs placebo. There were no new safety reports during the PMS phase that suggested an increased risk compared to results from the clinical studies. Moreover, the cardiac safety of glycopyrronium during the PMS phase was also consistent with the clinical data. Conclusion The overall safety profile of glycopyrronium was

  2. Safety and efficacy of the modified peroral endoscopic myotomy with shorter myotomy for achalasia patients: a prospective study.

    PubMed

    Wang, J; Tan, N; Xiao, Y; Chen, J; Chen, B; Ma, Z; Zhang, D; Chen, M; Cui, Y

    2015-01-01

    Peroral endoscopic myotomy (POEM) has been developed as a minimally invasive endoscopic treatment for achalasia for years. However, the optimal length of submucosal tunnel and myotomy of muscle bundles during procedure of POEM has not yet been determined, so we aim to assess safety and efficacy of modified POEM with shorter myotomy of muscle bundles in achalasia patients. Consecutive achalasia patients had been performed modified POEM with shorter myotomy, and assessed by symptoms, high-resolution manometry, and barium swallow examinations before and 3 months after POEM for safety and efficacy evaluation. Modified POEM with shorter submucosal tunnel (mean length 6.8 cm) and endoscopic myotomy of muscle bundles (total mean length 5.4 cm) were completed in 46 consecutive achalasia patients. During the 3-month follow up in all cases, significant improvement of symptoms (a significant drop in the Eckardt score 8.4 ± 3.2 vs. 2.7 ± 1.9; P < 0.001), decreased lower esophageal sphincter pressure (39.4 ± 10.1 vs. 24.4 ± 9.1 mmHg; P < 0.001) and integrated relaxation pressure (38.6 ± 10.4 vs. 25.7 ± 9.6 mmHg; P < 0.01), and a drop in height of esophagus barium-contrast column (5.4 ± 3.1 vs. 2.6 ± 1.8 cm; P < 0.001) were observed. The frequencies of adverse events were lower in those under endotracheal anesthesia and CO2 insufflations compared with intravenous anesthesia and air insufflations. Only three patients were found to have gastroesophageal reflux disease on follow up. Modified POEM with shorter myotomy under endotracheal anesthesia and CO2 insufflations shows its good safety and excellent short-term efficacy in the treatment of achalasia. But further studies are warranted to assess the long-term efficacy.

  3. Tropospheric Chemistry Studies using Observations from GOME and TOMS

    NASA Technical Reports Server (NTRS)

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

    2003-01-01

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

  4. Scoping Study on the Safety Impact of Valve Spacing in Natural Gas Pipelines

    SciTech Connect

    Sulfredge, Charles David

    2007-07-01

    The U.S. Department of Transportation's Pipeline and Hazardous Materials Safety Administration (PHMSA) is responsible for ensuring the safe, reliable, and environmentally sound operation of the nation's natural gas and hazardous liquid pipelines. Regulations adopted by PHMSA for gas pipelines are provided in 49 CFR 192, and spacing requirements for valves in gas transmission pipelines are presented in 49 CFR 192.179. The present report describes the findings of a scoping study conducted by Oak Ridge National Laboratory (ORNL) to assist PHMSA in assessing the safety impact of system valve spacing. Calculations of the pressures, temperatures, and flow velocities during a set of representative pipe depressurization transients were carried out using a one-dimensional numerical model with either ideal gas or real gas properties for the fluid. With both ideal gas and real gas properties, the high-consequence area radius for any resulting fire as defined by Stevens in GRI-00/0189 was evaluated as one measure of the pipeline safety. In the real gas case, a model for convective heat transfer from the pipe wall is included to assess the potential for shut-off valve failures due to excessively low temperatures resulting from depressurization cooling of the pipe. A discussion is also provided of some additional factors by which system valve spacing could affect overall pipeline safety. The following conclusions can be drawn from this work: (1) Using an adaptation of the Stephens hazard radius criteria, valve spacing has a negligible influence on natural gas pipeline safety for the pipeline diameter, pressure range, and valve spacings considered in this study. (2) Over the first 30 s of the transient, pipeline pressure has a far greater effect on the hazard radius calculated with the Stephens criteria than any variations in the transient flow decay profile and the average discharge rate. (3) Other factors besides the Stephens criteria, such as the longer burn time for an

  5. Safety and Efficacy Assessment of Two New Leprosy Skin Test Antigens: Randomized Double Blind Clinical Study

    PubMed Central

    Rivoire, Becky L.; Groathouse, Nathan A.; TerLouw, Stephen; Neupane, Kapil Dev; Ranjit, Chaman; Sapkota, Bishwa Raj; Khadge, Saraswoti; Kunwar, Chatra B.; Macdonald, Murdo; Hawksworth, Rachel; Thapa, Min B.; Hagge, Deanna A.; Tibbals, Melinda; Smith, Carol; Dube, Tina; She, Dewei; Wolff, Mark; Zhou, Eric; Makhene, Mamodikoe; Mason, Robin; Sizemore, Christine; Brennan, Patrick J.

    2014-01-01

    Background New tools are required for the diagnosis of pre-symptomatic leprosy towards further reduction of disease burden and its associated reactions. To address this need, two new skin test antigens were developed to assess safety and efficacy in human trials. Methods A Phase I safety trial was first conducted in a non-endemic region for leprosy (U.S.A.). Healthy non-exposed subjects (n = 10) received three titrated doses (2.5 µg, 1.0 µg and 0.1 µg) of MLSA-LAM (n = 5) or MLCwA (n = 5) and control antigens [Rees MLSA (1.0 µg) and saline]. A randomized double blind Phase II safety and efficacy trial followed in an endemic region for leprosy (Nepal), but involved only the 1.0 µg (high dose) and 0.1 µg (low dose) of each antigen; Tuberculin PPD served as a control antigen. This Phase II safety and efficacy trial consisted of three Stages: Stage A and B studies were an expansion of Phase I involving 10 and 90 subjects respectively, and Stage C was then conducted in two parts (high dose and low dose), each enrolling 80 participants: 20 borderline lepromatous/lepromatous (BL/LL) leprosy patients, 20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients, 20 household contacts of leprosy patients (HC), and 20 tuberculosis (TB) patients. The primary outcome measure for the skin test was delayed type hypersensitivity induration. Findings In the small Phase I safety trial, reactions were primarily against the 2.5 µg dose of both antigens and Rees control antigen, which were then excluded from subsequent studies. In the Phase II, Stage A/B ramped-up safety study, 26% of subjects (13 of 50) showed induration against the high dose of each antigen, and 4% (2 of 50) reacted to the low dose of MLSA-LAM. Phase II, Stage C safety and initial efficacy trial showed that both antigens at the low dose exhibited low sensitivity at 20% and 25% in BT/TT leprosy patients, but high specificity at 100% and 95% compared to TB patients. The high dose of both antigens

  6. Using data mining techniques to characterize participation in observational studies.

    PubMed

    Linden, Ariel; Yarnold, Paul R

    2016-12-01

    Data mining techniques are gaining in popularity among health researchers for an array of purposes, such as improving diagnostic accuracy, identifying high-risk patients and extracting concepts from unstructured data. In this paper, we describe how these techniques can be applied to another area in the health research domain: identifying characteristics of individuals who do and do not choose to participate in observational studies. In contrast to randomized studies where individuals have no control over their treatment assignment, participants in observational studies self-select into the treatment arm and therefore have the potential to differ in their characteristics from those who elect not to participate. These differences may explain part, or all, of the difference in the observed outcome, making it crucial to assess whether there is differential participation based on observed characteristics. As compared to traditional approaches to this assessment, data mining offers a more precise understanding of these differences. To describe and illustrate the application of data mining in this domain, we use data from a primary care-based medical home pilot programme and compare the performance of commonly used classification approaches - logistic regression, support vector machines, random forests and classification tree analysis (CTA) - in correctly classifying participants and non-participants. We find that CTA is substantially more accurate than the other models. Moreover, unlike the other models, CTA offers transparency in its computational approach, ease of interpretation via the decision rules produced and provides statistical results familiar to health researchers. Beyond their application to research, data mining techniques could help administrators to identify new candidates for participation who may most benefit from the intervention.

  7. Interpreting observational studies: why empirical calibration is needed to correct p-values

    PubMed Central

    Schuemie, Martijn J; Ryan, Patrick B; DuMouchel, William; Suchard, Marc A; Madigan, David

    2014-01-01

    Often the literature makes assertions of medical product effects on the basis of ‘ p < 0.05’. The underlying premise is that at this threshold, there is only a 5% probability that the observed effect would be seen by chance when in reality there is no effect. In observational studies, much more than in randomized trials, bias and confounding may undermine this premise. To test this premise, we selected three exemplar drug safety studies from literature, representing a case–control, a cohort, and a self-controlled case series design. We attempted to replicate these studies as best we could for the drugs studied in the original articles. Next, we applied the same three designs to sets of negative controls: drugs that are not believed to cause the outcome of interest. We observed how often p < 0.05 when the null hypothesis is true, and we fitted distributions to the effect estimates. Using these distributions, we compute calibrated p-values that reflect the probability of observing the effect estimate under the null hypothesis, taking both random and systematic error into account. An automated analysis of scientific literature was performed to evaluate the potential impact of such a calibration. Our experiment provides evidence that the majority of observational studies would declare statistical significance when no effect is present. Empirical calibration was found to reduce spurious results to the desired 5% level. Applying these adjustments to literature suggests that at least 54% of findings with p < 0.05 are not actually statistically significant and should be reevaluated. © 2013 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd. PMID:23900808

  8. Safety and reliability analysis in a polyvinyl chloride batch process using dynamic simulator-case study: Loss of containment incident.

    PubMed

    Rizal, Datu; Tani, Shinichi; Nishiyama, Kimitoshi; Suzuki, Kazuhiko

    2006-10-11

    In this paper, a novel methodology in batch plant safety and reliability analysis is proposed using a dynamic simulator. A batch process involving several safety objects (e.g. sensors, controller, valves, etc.) is activated during the operational stage. The performance of the safety objects is evaluated by the dynamic simulation and a fault propagation model is generated. By using the fault propagation model, an improved fault tree analysis (FTA) method using switching signal mode (SSM) is developed for estimating the probability of failures. The timely dependent failures can be considered as unavailability of safety objects that can cause the accidents in a plant. Finally, the rank of safety object is formulated as performance index (PI) and can be estimated using the importance measures. PI shows the prioritization of safety objects that should be investigated for safety improvement program in the plants. The output of this method can be used for optimal policy in safety object improvement and maintenance. The dynamic simulator was constructed using Visual Modeler (VM, the plant simulator, developed by Omega Simulation Corp., Japan). A case study is focused on the loss of containment (LOC) incident at polyvinyl chloride (PVC) batch process which is consumed the hazardous material, vinyl chloride monomer (VCM).

  9. Preregistration study on the safety and contraceptive efficacy of a progesterone-releasing vaginal ring in Chilean nursing women.

    PubMed

    Massai, R; Miranda, P; Valdés, P; Lavín, P; Zepeda, A; Casado, M E; Silva, M A; Fetis, G; Bravo, C; Chandía, O; Peralta, O; Croxatto, H B; Díaz, S

    1999-07-01

    The contraceptive efficacy and safety of a progesterone-releasing vaginal ring (PVR) manufactured in Chile were compared to that of the Copper T 380A IUD (T-Cu) in nursing women enrolled at three Chilean clinics. A total of 285 volunteers chose to use the PVR and 262 the T-Cu. Plasma progesterone levels attained with the ring decreased from 25 to 14 nmol/L from month 1 to month 3 of use. Ring replacement was scheduled every 3 months. Volunteers continued in the study until weaning or completing the continuous use of four PVRs. No pregnancies occurred in 2320 and 2183 woman-months of exposure with the PVR and the T-Cu, respectively. Lower continuation rates in the first 6 months because of problems with use and a longer lactational amenorrhea were observed in the PVR than in the T-Cu group. Breast-feeding performance and infant growth were similar in both groups. These results confirm the high efficacy and safety of the PVR for nursing women and have led to the registration of the PVR by Chilean health authorities.

  10. Applied Use of Safety Event Occurrence Control Charts of Harm and Non-Harm Events: A Case Study.

    PubMed

    Robinson, Susan N; Neyens, David M; Diller, Thomas

    2016-05-09

    Most hospitals use occurrence reporting systems that facilitate identifying serious events that lead to root cause investigations. Thus, the events catalyze improvement efforts to mitigate patient harm. A serious limitation is that only a few of the occurrences are investigated. A challenge is leveraging the data to generate knowledge. The goal is to present a methodology to supplement these incident assessment efforts. The framework affords an enhanced understanding of patient safety through the use of control charts to monitor non-harm and harm incidents simultaneously. This approach can identify harm and non-harm reporting rates and also can facilitate monitoring occurrence trends. This method also can expedite identifying changes in workflow, processes, or safety culture. Although unable to identify root causes, this approach can identify changes in near real time. This approach also supports evaluating safety or policy interventions that may not be observable in annual safety climate surveys.

  11. Safety of virus-resistant transgenic plants two decades after their introduction: lessons from realistic field risk assessment studies.

    PubMed

    Fuchs, Marc; Gonsalves, Dennis

    2007-01-01

    Potential safety issues have been raised with the development and release of virus-resistant transgenic plants. This review focuses on safety assessment with a special emphasis on crops that have been commercialized or extensively tested in the field such as squash, papaya, plum, grape, and sugar beet. We discuss topics commonly perceived to be of concern to the environment and to human health--heteroencapsidation, recombination, synergism, gene flow, impact on nontarget organisms, and food safety in terms of allergenicity. The wealth of field observations and experimental data is critically evaluated to draw inferences on the most relevant issues. We also express inside views on the safety and benefits of virus-resistant transgenic plants, and recommend realistic risk assessment approaches to assist their timely deregulation and release.

  12. Application of the Safety Attitudes Questionnaire (SAQ) in Albanian hospitals: a cross-sectional study

    PubMed Central

    Gabrani, Adriatik; Hoxha, Adrian; Simaku, Artan; Gabrani, Jonila (Cyco)

    2015-01-01

    Objective To establish the reliability and validity of the translated version of the Safety Attitudes Questionnaire (SAQ) by evaluating its psychometric properties and to determine possible differences among nurses and physicians regarding safety attitudes. Design A cross-sectional study utilising the Albanian version of the SAQ and a demographic questionnaire. Setting Four regional hospitals in Albania. Participants 341 healthcare providers, including 132 nurses and 209 doctors. Main outcome measure(s) The translation, construct validity and internal validity of the SAQ. The SAQ includes six scales and 30 items. Results A total of 341 valid questionnaires were returned, for a response rate of 70%. The confirmatory factor analysis and its goodness-of-fit indices (standardised root mean square residual 0.075, root mean square error of approximation 0.044 and comparative fit index 0.97) showed good model fit. The Cronbach's α values for each of the scales of the SAQ ranged from 0.64 to 0.82. The percentage of hospital healthcare workers who had a positive attitude was 60.3% for the teamwork climate, 57.2% for the safety climate, 58.4% for job satisfaction, 37.4% for stress recognition, 59.3% for the perception of management and 49.5% for working conditions. Intercorrelations showed that the subscales had moderate-to-high correlations with one another. Nurses were more hesitant to admit and report errors; only 55% of physicians and 44% of nurses endorsed this statement (χ2=4.9, p=0.02). Moreover, nurses received lower scores on team work compared with doctors (N 45.7 vs D 52.3, p=0.01). Doctors denied the effects of stress and fatigue on their performance (N 46.7 vs D 39.5, p<0.01), neglecting the workload. Conclusions The SAQ is a useful tool for evaluating safety attitudes in Albanian hospitals. In light of the health workforce's poor recognition of stress, establishing patient safety programmes should be a priority among policymakers in Albania. PMID:25877270

  13. Study of the post-derailment safety measures on low-speed derailment tests

    NASA Astrophysics Data System (ADS)

    Guo, Lirong; Wang, Kaiyun; Lin, Jianhui; Zhang, Bing; Chen, Zaigang; Song, Xinwu; Du, Gaofeng

    2016-07-01

    Prevention of train from derailment is the most important issue for the railway system. Keeping derailed vehicle close to the track centreline is beneficial to minimise the severe consequences associated with derailments. In this paper, the post-derailment safety measures are studied based on low-speed derailment tests. Post-derailment devices can prevent deviation of the train from the rail by catching the rail, and they are mounted under the axle box. Considering the different structures of vehicles, both trailer and motor vehicles are equipped with the safety device and then separately used in low-speed derailment tests. In derailment tests, two kinds of track, namely the CRTS-I slab ballastless track and the CRTS-II bi-block sleeper ballastless track, are adopted to investigate the effect of the track types on the derailment. In addition, the derailment speed and the weight of the derailed vehicle are also taken into account in derailment tests. The test results indicate that the post-derailment movement of the vehicle includes running and bounce. Reducing the derailment speed and increasing the weight of the head of the train are helpful to reduce the possibility for derailments. For the CRTS-I slab ballastless track, the safety device can prevent trailer vehicles from deviating from the track centreline. The gearbox plays an important role in controlling the lateral displacement of motor vehicle after a derailment while the safety device contributes less to keep derailed motor vehicles on the track centreline. The lateral distance between the safety device and rails should be larger than 181.5 mm for protecting the fasteners system. And for the CRTS-II bi-block sleeper ballastless track, it helps to decrease the post-derailment distance due to the longitudinal impacts with sleepers. It can also restrict the lateral movement of derailed vehicle due to the high shoulders. The results suggest that, CRTS-II bi-block sleeper ballastless track should be widely used

  14. Efficacy and safety of a new single-port model for appendectomy: Experimental study on swine

    PubMed Central

    Olijnyk, José Gustavo; Ferreira, Paulo Walter; Nácul, Miguel Prestes; Cavazzola, Leandro Totti

    2016-01-01

    CONTEXT: With the cooperation of surgeons and the engineering division of the company Bhio supply© (Esteio-RS, Brazil), a permanent single port was developed. AIMS: An experimental study assessed the safety and efficacy of the device using a swine laparoscopic appendectomy model (right salpingo-oophorectomy). SETTINGS AND DESIGN: Experimental randomised study. MATERIALS AND METHODS: A total of 20 pigs were randomised for the conventional laparoscopic (CL) three-trocar technique or the single Centry port (CPort) with two working channels, aided by a transparietal thread. Operative times, surgical complications, CO2 use, and pneumoperitoneal pressure were checked. Pressure and chromopertubation tests assessed the ligatures. STATISTICAL ANALYSIS USED: For quantitative outcomes, the Fisher's exact test analysed the samples to compare the surgeons in each group, the ANOVA test for parametric data (volume and pressure) and the Student's t-test for analysis of the fascial incision length. The binaries and isolated occurrence events were described in percentages. RESULTS: For all cases, pneumoperitoneum was maintained. The CPort group, however, resulted in higher CO2 use (26.18 l; standard deviation [SD] ± 11.09) than CL group (5.69 l; SD ± 2.44) (P < 0.01). The mean pressure in CPort group (6.604 mmHg, SD ± 1.793) was comparatively lower than in CL group (7.382 mmHg, SD ± 1.833) (P = 0.363). There was no statistical difference between operative times, ligature safety or adverse surgical events between the different groups and surgeons. CONCLUSION: The surgical technique used with the single port showed no differences in safety and efficacy. Though it does require more CO2 use, its working dynamics did not lead to increased operative times. The results were similar between the two surgeons in the study, suggesting that they can be reproduced. PMID:27073304

  15. Study of the safety and immunogenicity of the synthetic malaria SPf66 vaccine in children aged 1-14 years.

    PubMed

    Patarroyo, G; Franco, L; Amador, R; Murillo, L A; Rocha, C L; Rojas, M; Patarroyo, M E

    1992-01-01

    Safety and immunogenicity tests of the SPf66 malaria vaccine have been carried out on a population of children, aged 1 to 14 years, in the town of Tumaco, Colombia. Adverse reactions measured after each vaccination were local and minimal, and observed in only a small percentage of the vaccinated children. One year later, no delayed reaction was evident. The majority of the child population developed high antibody titres against SPf66 and the degree of response did not vary with age. These induced antibodies recognize the native parasite proteins, in particular the molecules from which the amino acid sequence of this vaccine was deduced. These studies demonstrate that the SPf66 vaccine is safe and highly immunogenic for use in children greater than 1 year old.

  16. Linking Indigenous Knowledge and Observed Climate Change Studies

    NASA Technical Reports Server (NTRS)

    Alexander, Chief Clarence; Bynum, Nora; Johnson, Liz; King, Ursula; Mustonen, Tero; Neofotis, Peter; Oettle, Noel; Rosenzweig, Cynthia; Sakakibara, Chie; Shadrin, Chief Vyacheslav; Vicarelli, Marta; Waterhouse, Jon; Weeks, Brian

    2010-01-01

    We present indigenous knowledge narratives and explore their connections to documented temperature and other climate changes and observed climate change impact studies. We then propose a framework for enhancing integration of these indigenous narratives of observed climate change with global assessments. Our aim is to contribute to the thoughtful and respectful integration of indigenous knowledge with scientific data and analysis, so that this rich body of knowledge can inform science, and so that indigenous and traditional peoples can use the tools and methods of science for the benefit of their communities if they choose to do so. Enhancing ways of understanding such connections are critical as the Intergovernmental Panel on Climate Change Fifth Assessment process gets underway.

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

    NASA Technical Reports Server (NTRS)

    Avallone, Linnea

    2001-01-01

    At the time this proposal was submitted, recent publications had suggested an important role for transport of midlatitude air into the tropical lower stratosphere. Most of these studies had employed data that gave only a time-averaged picture, making it difficult to determine the nature of the transport processes responsible for the observed behavior. We proposed to analyze observations of long-lived trace gases, such as nitric acid, methane, nitrous oxide, and chlorofluorocarbons, made from the Upper Atmosphere Research Satellite, to investigate the seasonal behavior of mixing between the midlatitudes and tropics. We planned to construct probability distributions of the concentrations of these species over small altitude ranges and to compare them to expectations based on modeled mean concentrations and knowledge of instrument precision. Differences from expectation were to be analyzed with respect to meteorological parameters to determine whether wave activity may have induced apparent mixing.

  18. Concept study of an observation preparation tool for MICADO

    NASA Astrophysics Data System (ADS)

    Wegner, Michael; Schlichter, Jörg

    2016-07-01

    MICADO, the near-infrared Multi-AO Imaging Camera for Deep Observations and first light instrument for the European ELT, will provide capabilities for imaging, coronagraphy, and spectroscopy. As usual, MICADO observations will have to be prepared in advance, including AO and secondary guide star selection, offset/dither pattern definition, and an optimization for the most suitable configuration. A visual representation of the latter along with graphical and scripting interfaces is desirable. We aim at developing a flexible and user-friendly application that enhances or complements the ESO standard preparation software. Here, we give a summary of the requirements on such a tool, report on the status of our conceptual study and present a first proof-of-concept implementation.

  19. Supplementing Oscat winds with Saral Altika observations for cyclone studies

    NASA Astrophysics Data System (ADS)

    Niharika, K.; Usha Sundari, H. S. V.; Prasad, A. V. V.; Kumari, E. V. S. Sita; Dadhwal, V. K.; Ali, M. M.

    2014-11-01

    Accurate prediction of life cycle of cyclone is very critical to the disaster management practices. Since the cyclones originate over the oceans where in situ observations are limited, we have to resort to the remote sensing techniques. Both optical and microwave sensors help studying the cyclones. While scatterometer provide wind vectors, altimeters can give only wind speed. In this paper we present how altimeter measurements can supplement the scatterometer observations in determining the radius of maximum winds (RMW). Sustained maximum winds, indicator for the intensity of the cyclone, are within the eye wall of a cyclone at a distance of RMW. This parameter is also useful in predicting right time of the storm surge. In this paper we used the wind speed estimations from AltiKa, an altimeter operating at Ka band.

  20. 75 FR 53701 - Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-01

    ... FDA's Office of Orphan Products Development (OPD) grant program. The document was published with an.... FDA-2010-N-0394] Clinical Studies of Safety and Effectiveness of Orphan Products Research...

  1. Patient’s safety culture among Tunisian healthcare workers: results of a cross sectional study in university hospital

    PubMed Central

    Cheikh, Asma Ben; Bouafia, Nabiha; Mahjoub, Mohamed; Ezzi, Olfa; Nouira, Amel; Njah, Mansour

    2016-01-01

    Introduction Healthcare safety has become a public health priority in developed world. Development of safety culture care is fundamental pillar to any strategy for improving quality and safety care. The objective of this study is to measure level of patients’ safety culture among healthcare professionals at university hospital, center Farhat Hached Sousse (Tunisia). Methods We conducted, in 2013, a descriptive study among all licensed physicians (n= 116) and a representative sample of paramedical staff (n= 203) exercising at university hospital center Farhat Hached Sousse (Tunisia). Measuring instrument used is a valid questionnaire containing ten safety care dimensions. Data were analyzed using SPSS version 19. Results The response rates were 74.1% for physicians and 100% for paramedical staff. Overall score of different dimensions varies between 32.7% and 68.8%. Dimension having most developed score (68.8%) was perception of “Frequency and reporting adverse events”. Dimension with lowest score (32.7%) was “Management support for safety care”. Conclusion Our study has allowed us to conclude that all dimensions of patients’ safety culture need to be improved among our establishment’s professionals. Therefore, more efforts are necessary in order to develop a security culture based on confidence, learning, communication and team work and rejecting sanction, blame, criminalization and punitive reporting. PMID:28154654

  2. Relating voltage and thermal safety in Li-ion battery cathodes: a high-throughput computational study.

    PubMed

    Jain, Anubhav; Hautier, Geoffroy; Ong, Shyue Ping; Dacek, Stephen; Ceder, Gerbrand

    2015-02-28

    High voltage and high thermal safety are desirable characteristics of cathode materials, but difficult to achieve simultaneously. This work uses high-throughput density functional theory computations to evaluate the link between voltage and safety (as estimated by thermodynamic O2 release temperatures) for over 1400 cathode materials. Our study indicates that a strong inverse relationship exists between voltage and safety: just over half the variance in O2 release temperature can be explained by voltage alone. We examine the effect of polyanion group, redox couple, and ratio of oxygen to counter-cation on both voltage and safety. As expected, our data demonstrates that polyanion groups improve safety when comparing compounds with similar voltages. However, a counterintuitive result of our study is that polyanion groups produce either no benefit or reduce safety when comparing compounds with the same redox couple. Using our data set, we tabulate voltages and oxidation potentials for over 105 combinations of redox couple/anion, which can be used towards the design and rationalization of new cathode materials. Overall, only a few compounds in our study, representing limited redox couple/polyanion combinations, exhibit both high voltage and high safety. We discuss these compounds in more detail as well as the opportunities for designing safe, high-voltage cathodes.

  3. Critical review of the reactor-safety study radiological health effects model. Final report

    SciTech Connect

    Cooper, D.W.; Evans, J.S.; Jacob, N.; Kase, K.R.; Maletskos, C.J.; Robertson, J.B.; Smith, D.G.

    1983-03-01

    This review of the radiological health effects models originally presented in the Reactor Safety Study (RSS) and currently used by the US Nuclear Regulatory Commission (NRC) was undertaken to assist the NRC in determining whether or not to revise the models and to aid in the revision, if undertaken. The models as presented in the RSS and as implemented in the CRAC (Calculations of Reactor Accident Consequences) Code are described and critiqued. The major elements analyzed are those concerning dosimetry, early effects, and late effects. The published comments on the models are summarized, as are the important findings since the publication of the RSS.

  4. Lithium-Sulfur Dioxide (Li/SO2) Battery Safety Hazards - Thermal Studies.

    DTIC Science & Technology

    1982-03-01

    Dioxide and Lithium - Thionyl Chloride Cells," J. Electrochem. Soc., 128, 508 (1981). 6. Bro, P., "Heat Generation in Li/S0 2 Cells During Low Rate...ElMER. K Y KIM. H V VENKATASETTT M60921-S1-C-006 U7CLASSIFIED NLfl3hmhmhhhhhil momhmhhohhohl LITHIUM -SULFUR DIOXIDE (Li/SO2) BATTERY SAFETY HAZARDS...icro-calorime~ter studies ruiN the heat of reaction for the lithium / acetintileiieIT-rnto be -54 .6 -F1.0 kcal/mole*-Li. Lithium /aluminum alloy A was

  5. Case study: reconciling the quality and safety gap through strategic planning.

    PubMed

    Jeffs, Lianne; Merkley, Jane; Jeffrey, Jana; Ferris, Ella; Dusek, Janice; Hunter, Catherine

    2006-05-01

    An essential outcome of professional practice environments is the provision of high-quality, safe nursing care. To mitigate the quality and safety chasm, nursing leadership at St. Michael's Hospital undertook a strategic plan to enhance the nursing professional practice environment. This case study outlines the development of the strategic planning process: the driving forces (platform); key stakeholders (process and players); vision, guiding principles, strategic directions, framework for action and accountability (plan); lessons learned (pearls); and next steps to moving forward the vision, strategic directions and accountability mechanisms (passion and perseverance).

  6. Open-label extension studies: do they provide meaningful information on the safety of new drugs?

    PubMed

    Day, Richard O; Williams, Kenneth M

    2007-01-01

    The number of open-label extension studies being performed has increased enormously in recent years. Often it is difficult to differentiate between these extension studies and the double-blind, controlled studies that preceded them. If undertaken primarily to gather more patient-years of exposure to the new drug in order to understand and gain confidence in its safety profile, open-label extension studies can play a useful and legitimate role in drug development and therapeutics. However, this can only occur if the open-label extension study is designed, executed, analysed and reported competently. Most of the value accrued in open-label extension studies is gained from a refinement in the perception of the expected incidence of adverse effects that have most likely already been identified as part of the preclinical and clinical trial programme. We still have to rely heavily on post-marketing safety surveillance systems to alert us to type B (unpredictable) adverse reactions because open-label extension studies are unlikely to provide useful information about these types of often serious and relatively rare adverse reactions. Random allocation into test and control groups is needed to produce precise incidence data on pharmacologically expected, or type A, adverse effects. Some increased confidence about incidence rates might result from the open-label extension study; however, as these studies are essentially uncontrolled and biased, the data are not of great value. Other benefits have been proposed to be gained from open-label extension studies. These include ongoing access to an effective but otherwise unobtainable medicine by the volunteers who participated in the phase III pivotal trials. However, there are unappreciated ethical issues about the appropriateness of enrolling patients whose response to previous treatment is uncertain, largely because treatment allocation in the preceding randomised, double-blind, controlled trial has not been revealed at the

  7. Observational studies of regions of massive star formation

    NASA Astrophysics Data System (ADS)

    Cooper, Heather Danielle Blythe

    2013-03-01

    Massive stars have a profound influence on their surroundings. However, relatively little is known about their formation. The study of massive star formation is hindered by a lack of observational evidence, primarily due to difficulties observing massive stars at early stages in their development. The Red MSX Source survey (RMS survey) is a valuable tool with which to address these issues. Near-infrared H- and K-band spectra were taken for 247 candidate massive young stellar objects (MYSOs), selected from the RMS survey. 195 (∼80%) of the targets are YSOs, of which 131 are massive YSOs (LBOL>5E3L⊙, M>8 M⊙). This is the largest spectroscopic study of massive YSOs to date. This study covers minimally obscured objects right through to very red, dusty sources. Almost all YSOs show some evidence for emission lines, though there is a wide variety of observed properties, with HI, H2 Fe II, and CO among the most commonly observed lines. Evidence for disks and outflows was frequently seen. Comparisons of Brγ and H2 emission with low mass YSOs suggest that the emission mechanism for these lines is the same for low-, intermediate-, and high-mass YSOs, i.e. high-mass YSOs appear to resemble scaled-up versions of low-mass YSOs. It was found that the YSOs form an evolutionary sequence, based on their spectra, consistent with the existing theoretical models. Type I YSOs have strong H2 emission, no ionized lines, and are redder than the other two subtypes. As such, these are considered to be the youngest sources. The Type III sources are bluest, and therefore considered to be the oldest subtype. They have strong H I lines and fluorescent Fe II 1.6878 μm emission. They may also have weak H2 emission. Type III sources may even be beginning to form a mini-H II region. XSHOOTER data from 10 Herbig Be stars were analysed. The evidence suggests that winds and disks are common among Herbig stars, as they are among their main sequence classical Be star counterparts. Line

  8. Globally Gridded Satellite (GridSat) Observations for Climate Studies

    NASA Technical Reports Server (NTRS)

    Knapp, Kenneth R.; Ansari, Steve; Bain, Caroline L.; Bourassa, Mark A.; Dickinson, Michael J.; Funk, Chris; Helms, Chip N.; Hennon, Christopher C.; Holmes, Christopher D.; Huffman, George J.; Kossin, James P.; Lee, Hai-Tien; Loew, Alexander; Magnusdottir, Gudrun

    2012-01-01

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

  9. Efficacy and safety of acupuncture for chronic dizziness: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Dizziness is one of the most challenging symptoms in medicine. No medication for dizziness in current use has well-established curative or prophylactic value or is suitable for long-term palliative use. Unconventional remedies, such as acupuncture, should be considered and scientifically evaluated. However, there has been relatively little evidence in randomized controlled clinical trials on acupuncture to treat chronic dizziness. The aim of our study is to evaluate the efficacy and safety of acupuncture in patients with dizziness. Methods/Design This trial is a randomized, single-blind, controlled study. A total of 80 participants will be randomly assigned to two treatment groups receiving acupuncture and sham acupuncture treatment, respectively, for 4 weeks. The primary outcome measures are the Dizziness Handicap Inventory (DHI) and the Vertigo Symptom Scale (VSS). Treatment will be conducted over a period of 4 weeks, at a frequency of two sessions per week. The assessment is at baseline (before treatment initiation), 4 weeks after the first acupuncture session, and 8 weeks after the first acupuncture session. Discussion The results from this study will provide clinical evidence on the efficacy and safety of acupuncture in patients with chronic dizziness. Trial registration International Standard Randomized Controlled Trial Number Register: ISRCTN52695239 PMID:24330810

  10. Safety Evaluation of CNS Administered Biologics-Study Design, Data Interpretation, and Translation to the Clinic.

    PubMed

    Vuillemenot, Brian R; Korte, Sven; Wright, Teresa L; Adams, Eric L; Boyd, Robert B; Butt, Mark T

    2016-07-01

    Many central nervous system (CNS) diseases are inadequately treated by systemically administered therapies due to the blood brain barrier (BBB), which prevents achieving adequate drug concentrations at sites of action. Due to the increasing prevalence of neurodegenerative diseases and the inability of most systemically administered therapies to cross the BBB, direct CNS delivery will likely play an increasing role in treatment. Administration of large molecules, cells, viral vectors, oligonucleotides, and other novel therapies directly to the CNS via the subarachnoid space, ventricular system, or parenchyma overcomes this obstacle. Clinical experience with direct CNS administration of small molecule therapies suggests that this approach may be efficacious for the treatment of neurodegenerative disorders using biological therapies. Risks of administration into the brain tissue or cerebrospinal fluid include local damage from implantation of the delivery system and/or administration of the therapeutic and reactions affecting the CNS. Preclinical safety studies on CNS administered compounds must differentiate between the effects of the test article, the delivery device, and/or the vehicle, and assess exacerbations of reactions due to combinations of effects. Animal models characterized for safety assessment of CNS administered therapeutics have enabled human trials, but interpretation can be challenging. This manuscript outlines the challenges of preclinical intrathecal/intracerebroventricular/intraparenchymal studies, evaluation of results, considerations for special endpoints, and translation of preclinical findings to enable first-in-human trials. Recommendations will be made based on the authors' collective experience with conducting these studies to enable clinical development of CNS-administered biologics.

  11. Safety profile of sural nerve in posterolateral approach to the ankle joint: MRI study.

    PubMed

    Ellapparadja, Pregash; Husami, Yaya; McLeod, Ian

    2014-05-01

    The posterolateral approach to ankle joint is well suited for ORIF of posterior malleolar fractures. There are no major neurovascular structures endangering this approach other than the sural nerve. The sural nerve is often used as an autologous peripheral nerve graft and provides sensation to the lateral aspect of the foot. The aim of this paper is to measure the precise distance of the sural nerve from surrounding soft tissue structures so as to enable safe placement of skin incision in posterolateral approach. This is a retrospective image review study involving 64 MRI scans. All measurements were made from Axial T1 slices. The key findings of the paper is the safety window for the sural nerve from the lateral border of tendoachilles (TA) is 7 mm, 1.3 cm and 2 cm at 3 cm above ankle joint, at the ankle joint and at the distal tip of fibula respectively. Our study demonstrates the close relationship of the nerve in relation to TA and fibula in terms of exact measurements. The safety margins established in this study should enable the surgeon in preventing endangerment of the sural nerve encountered in this approach.

  12. A statistical study of merging galaxies: Theory and observations

    NASA Technical Reports Server (NTRS)

    Chatterjee, Tapan K.

    1990-01-01

    A study of the expected frequency of merging galaxies is conducted, using the impulsive approximation. Results indicate that if we consider mergers involving galaxy pairs without halos in a single crossing time or orbital period, the expected frequency of mergers is two orders of magnitude below the observed value for the present epoch. If we consider mergers involving several orbital periods or crossing times, the expected frequency goes up by an order of magnitude. Preliminary calculation indicate that if we consider galaxy mergers between pairs with massive halos, the merger is very much hastened.

  13. How safe do teenagers behave on Facebook? An observational study.

    PubMed

    Vanderhoven, Ellen; Schellens, Tammy; Valcke, Martin; Raes, Annelies

    2014-01-01

    The substantial use of social network sites by teenagers has raised concerns about privacy and security. Previous research about behavior on social network sites was mostly based on surveys and interviews. Observational research overcomes problems inherent to this research method, for example social desirability. However, existing observational research mostly focuses on public profiles of young adults. Therefore, the current observation-study includes 1050 public and non-public Facebook-profiles of teenagers (13-18) to investigate (1) what kind of information teenagers post on their profile, (2) to what extent they protect this information using privacy-settings and (3) how much risky information they have on their profile. It was found that young people mostly post pictures, interests and some basic personal information on their profile. Some of them manage their privacy-settings as such that this information is reserved for friends' eyes only, but a lot of information is accessible on the friends-of-friends' pages. Although general risk scores are rather low, more detailed analyses show that teenagers nevertheless post a significant amount of risky information. Moreover, older teenagers and girls post more (risky) information while there are no differences in applying privacy settings. We found no differences in the Facebook behavior of teenagers enrolled in different education forms. Implications of these results are discussed.

  14. Palliative care team visits. Qualitative study through participant observation

    PubMed Central

    Bueno Pernias, Maria José; Hueso Montoro, César; Guardia Mancilla, Plácido; Montoya Juárez, Rafael; García Caro, Maria Paz

    2016-01-01

    Objectives: To describe the clinical encounters that occur when a palliative care team provides patient care and the features that influence these encounters and indicate whether they are favorable or unfavorable depending on the expectations and feelings of the various participants. Methods: A qualitative case study conducted via participant observation. A total of 12 observations of the meetings of palliative care teams with patients and families in different settings (home, hospital and consultation room) were performed. The visits were follow-up or first visits, either scheduled or on demand. Content analysis of the observation was performed. Results: The analysis showed the normal follow-up activity of the palliative care unit that was focused on controlling symptoms, sharing information and providing advice on therapeutic regimens and care. The environment appeared to condition the patients' expressions and the type of patient relationship. Favorable clinical encounter conditions included kindness and gratitude. Unfavorable conditions were deterioration caused by approaching death, unrealistic family objectives and limited resources. Conclusion: Home visits from basic palliative care teams play an important role in patient and family well-being. The visits seem to focus on controlling symptoms and are conditioned by available resources. PMID:27226663

  15. Safety and Feasibility of Transcranial Direct Current Stimulation in Pediatric Hemiparesis: Randomized Controlled Preliminary Study

    PubMed Central

    Feyma, Tim; Menk, Jeremiah; Usset, Michelle; Vaith, Amy; Wood, Teddi Jean; Worthington, Rebecca; Krach, Linda E.

    2015-01-01

    Background Transcranial direct current stimulation (tDCS) is a form of noninvasive brain stimulation that has shown improved adult stroke outcomes. Applying tDCS in children with congenital hemiparesis has not yet been explored. Objective The primary objective of this study was to explore the safety and feasibility of single-session tDCS through an adverse events profile and symptom assessment within a double-blind, randomized placebo-controlled preliminary study in children with congenital hemiparesis. A secondary objective was to assess the stability of hand and cognitive function. Design A double-blind, randomized placebo-controlled pretest/posttest/follow-up study was conducted. Setting The study was conducted in a university pediatric research laboratory. Participants Thirteen children, ages 7 to 18 years, with congenital hemiparesis participated. Measurements Adverse events/safety assessment and hand function were measured. Intervention Participants were randomly assigned to either an intervention group or a control group, with safety and functional assessments at pretest, at posttest on the same day, and at a 1-week follow-up session. An intervention of 10 minutes of 0.7 mA tDCS was applied to bilateral primary motor cortices. The tDCS intervention was considered safe if there was no individual decline of 25% or group decline of 2 standard deviations for motor evoked potentials (MEPs) and behavioral data and no report of adverse events. Results No major adverse events were found, including no seizures. Two participants did not complete the study due to lack of MEP and discomfort. For the 11 participants who completed the study, group differences in MEPs and behavioral data did not exceed 2 standard deviations in those who received the tDCS (n=5) and those in the control group (n=6). The study was completed without the need for stopping per medical monitor and biostatisticial analysis. Limitations A limitation of the study was the small sample size, with data

  16. Treatment decisions in multiple sclerosis - insights from real-world observational studies.

    PubMed

    Trojano, Maria; Tintore, Mar; Montalban, Xavier; Hillert, Jan; Kalincik, Tomas; Iaffaldano, Pietro; Spelman, Tim; Sormani, Maria Pia; Butzkueven, Helmut

    2017-02-01

    The complexity of multiple sclerosis (MS) treatment means that doctors and decision-makers need the best available evidence to make the best decisions for patient care. Randomized controlled trials (RCTs) are accepted as the gold standard for assessing the efficacy and safety of any new drug, but conclusions of these trials do not always aid in daily decision-making processes. Indeed, RCTs are usually conducted in ideal conditions, so can measure efficacy only in restricted and unrepresentative populations. In the past decade, a growing number of MS databases and registries have started to produce long-term outcome data from large cohorts of patients with MS treated with disease-modifying therapies in real-world settings. Such observational studies are addressing issues that are otherwise difficult or impossible to study. In this Review, we focus on the most recently published observational studies designed to identify predictors of poor outcome and treatment response or failure, and to evaluate the relative and long-term effectiveness of currently used MS treatments. We also outline the statistical approaches that are most commonly used to reduce bias and limitations in these studies, and the challenges associated with the use of 'big MS data' to facilitate the implementation of personalized medicine in MS.

  17. Assessment of Seizure Severity with Adjunctive Lamotrigine Therapy: Results from a U.S. Observational Study.

    PubMed

    Bryant-Comstock, Lynda; Scott-Lennox, Jane; Lennox, Richard

    2001-04-01

    THE ADJUNCTIVE LAMICTAL (LAMOTRIGINE) IN EPILEPSY: Response to Treatment (ALERT) study was an observational study designed to assess the safety of lamotrigine in patients with refractory partial seizures when used in a general practice setting. We measured the impact of adjunctive lamotrigine therapy for 16 weeks on the severity of seizures using the Liverpool Seizure Severity Scale (LSSS). This questionnaire was scored using a revised scoring procedure that assesses the impact of treatment on the patients "most severe seizure." Data from the LSSS were also compared with physician-rated changes of seizure severity. Patients who completed 16 weeks of lamotrigine treatment showed a significant reduction in LSSS scores when compared with patients who discontinued lamotrigine (change scores: patient's taking lamotrigine at Week 16, 9.2 +/- 23.4; patients who discontinued lamotrigine by Week 16, 0.8 +/- 23.4, P < 0.05). These findings were supported by significant reductions in physician ratings of seizure severity in patients who completed 16 weeks of lamotrigine therapy. Seizure severity is an important outcome in the study of antiepileptic medication. Data from this observational study suggest that lamotrigine is effective in reducing seizure severity when used as an adjunctive therapy in patients with refractory partial seizures.

  18. Efficacy and Safety of Alogliptin in Patients With Type 2 Diabetes: Analysis of the ATTAK-J Study

    PubMed Central

    Takeda, Hiroshi; Sasai, Nobuo; Ito, Shogo; Obana, Mitsuo; Takuma, Tetsuo; Takai, Masahiko; Kaneshige, Hideaki; Machimura, Hideo; Kanamori, Akira; Nakajima, Kazumi; Matsuba, Ikuro

    2016-01-01

    Background Dipeptidyl peptidase-4 (DPP-4) inhibitors have been shown to reduce hemoglobin A1c (HbA1c) in patients with type 2 diabetes, but the reduction varies between patients and adequate glycemic control may not be achieved. We evaluated the efficacy and safety of the DPP-4 inhibitor alogliptin in the real clinical setting, and analyzed factors associated with the improvement of HbA1c by alogliptin treatment. Methods A retrospective observational study was performed in patients with type 2 diabetes attending hospitals or clinics belonging to the Kanagawa Physicians Association who received treatment with alogliptin for 1 year or longer. Patients using insulin were excluded from the study. The efficacy endpoints were HbA1c (National Glycohemoglobin Standardization Program value), blood glucose (fasting/postprandial), body weight, blood pressure (systolic/diastolic), liver function (glutamate oxaloacetate transaminase, glutamate pyruvate transaminase, and γ-glutamyl transpeptidase), kidney function (serum creatinine and estimated glomerular filtration rate), serum lipids (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides), and serum amylase. Adverse events were compiled to assess safety. Results Of 330 patients whose case records were collected, 27 patients were excluded for protocol violations, leaving 303 patients to form the full analysis set. Compared with baseline, HbA1c showed a decrease by 0.54±1.22% (mean ± standard deviation) after 12 months of alogliptin treatment. Factor analysis demonstrated that the change of HbA1c after 12 months was significantly influenced by the baseline HbA1c level, duration of diabetes, concomitant use of sulfonylureas, and compliance with diet therapy. In addition, there was a significant reduction of total cholesterol, low-density lipoprotein cholesterol, and the estimated glomerular filtration rate after 12 months of alogliptin treatment, as well as a

  19. The development of the Suicidal Patient Observation Chart (SPOC): Delphi study.

    PubMed

    Björkdahl, A; Nyberg, U; Runeson, B; Omérov, P

    2011-08-01

    Constant observation is a method used to insure the safety of suicidal inpatients. It involves structure and control as well as flexibility and the development of a relationship between the observer and the patient. It has been found that important observations may go unnoticed by the observer or fail to be communicated to the multidisciplinary team because of a lack of sufficient training and systematic documentation. We therefore conducted a Delphi survey to collect opinions on what would be important to observe during constant observation of suicidal patients. A panel of experienced clinicians, service users and researchers reached consensus on 37 of 40 observation items (92%). Of these, 28 were rated as the most important. As a result, we developed a form for systematic observer documentation in clinical practice, the Suicidal Patient Observation Chart. The Suicidal Patient Observation Chart includes the 28 items and covers 24 separate observation periods.

  20. Pandemrix™ and narcolepsy: A critical appraisal of the observational studies

    PubMed Central

    Verstraeten, Thomas; Cohet, Catherine; Dos Santos, Gaël; Ferreira, Germano LC; Bollaerts, Kaatje; Bauchau, Vincent; Shinde, Vivek

    2016-01-01

    A link between Pandemrix™ (AS03-adjuvanted H1N1 pandemic influenza vaccine, GSK Vaccines, Belgium) and narcolepsy was first suspected in 2010 in Sweden and Finland following a number of reports in children and adolescents. Initial scepticism about the reported association faded as additional countries reported similar findings, leading several regulatory authorities to restrict the use of Pandemrix™. The authors acknowledge that currently available data suggest an increased risk of narcolepsy following vaccination with Pandemrix™; however, from an epidemiologist's perspective, significant methodological limitations of the studies have not been fully addressed and raise questions about the reported risk estimates. We review the most important biases and confounders that potentially occurred in 12 European studies of the observed association between Pandemrix™ and narcolepsy, and call for further analyses and debate. PMID:26379011

  1. Pandemrix™ and narcolepsy: A critical appraisal of the observational studies.

    PubMed

    Verstraeten, Thomas; Cohet, Catherine; Dos Santos, Gaël; Ferreira, Germano Lc; Bollaerts, Kaatje; Bauchau, Vincent; Shinde, Vivek

    2016-01-01

    A link between Pandemrix™ (AS03-adjuvanted H1N1 pandemic influenza vaccine, GSK Vaccines, Belgium) and narcolepsy was first suspected in 2010 in Sweden and Finland following a number of reports in children and adolescents. Initial scepticism about the reported association faded as additional countries reported similar findings, leading several regulatory authorities to restrict the use of Pandemrix™. The authors acknowledge that currently available data suggest an increased risk of narcolepsy following vaccination with Pandemrix™; however, from an epidemiologist's perspective, significant methodological limitations of the studies have not been fully addressed and raise questions about the reported risk estimates. We review the most important biases and confounders that potentially occurred in 12 European studies of the observed association between Pandemrix™ and narcolepsy, and call for further analyses and debate.

  2. Spacelab Science Results Study. Volume 1; External Observations

    NASA Technical Reports Server (NTRS)

    Naumann, Robert J. (Compiler)

    1999-01-01

    Some of the 36 Spacelab missions were more or less dedicated to specific scientific disciplines, while other carried a eclectic mixture of experiments ranging from astrophysics to life sciences. However, the experiments can be logically classified into two general categories; those that make use of the Shuttle as an observing platform for external phenomena (including those which use the Shuttle in an interactive mode) and those which use the Shuttle as a microgravity laboratory. This first volume of this Spacelab Science Results study will be devoted to experiments of the first category. The disciplines included are Astrophysics, Solar Physics, Space Plasma Physics, Atmospheric Sciences, and Earth Sciences. Because of the large number of microgravity investigations, Volume 2 will be devoted to Microgravity Sciences, which includes Fluid Physics, Combustion Science, Materials Science, and Biotechnology, and Volume 3 will be devoted to Space Life Sciences, which studies the response and adaptability of living organisms to the microgravity environment.

  3. An observational study of entrainment rate in deep convection

    DOE PAGES

    Guo, Xiaohao; Lu, Chunsong; Zhao, Tianliang; ...

    2015-09-22

    This study estimates entrainment rate and investigates its relationships with cloud properties in 156 deep convective clouds based on in-situ aircraft observations during the TOGA-COARE (Tropical Ocean Global Atmosphere Coupled Ocean Atmosphere Response Experiment) field campaign over the western Pacific. To the authors’ knowledge, this is the first study on the probability density function of entrainment rate, the relationships between entrainment rate and cloud microphysics, and the effects of dry air sources on the calculated entrainment rate in deep convection from an observational perspective. Results show that the probability density function of entrainment rate can be well fitted by lognormal,more » gamma or Weibull distribution, with coefficients of determination being 0.82, 0.85 and 0.80, respectively. Entrainment tends to reduce temperature, water vapor content and moist static energy in cloud due to evaporative cooling and dilution. Inspection of the relationships between entrainment rate and microphysical properties reveals a negative correlation between volume-mean radius and entrainment rate, suggesting the potential dominance of homogeneous mechanism in the clouds examined. The entrainment rate and environmental water vapor content show similar tendencies of variation with the distance of the assumed environmental air to the cloud edges. Their variation tendencies are non-monotonic due to the relatively short distance between adjacent clouds.« less

  4. An observational study of entrainment rate in deep convection

    SciTech Connect

    Guo, Xiaohao; Lu, Chunsong; Zhao, Tianliang; Zhang, Guang Jun; Liu, Yangang

    2015-09-22

    This study estimates entrainment rate and investigates its relationships with cloud properties in 156 deep convective clouds based on in-situ aircraft observations during the TOGA-COARE (Tropical Ocean Global Atmosphere Coupled Ocean Atmosphere Response Experiment) field campaign over the western Pacific. To the authors’ knowledge, this is the first study on the probability density function of entrainment rate, the relationships between entrainment rate and cloud microphysics, and the effects of dry air sources on the calculated entrainment rate in deep convection from an observational perspective. Results show that the probability density function of entrainment rate can be well fitted by lognormal, gamma or Weibull distribution, with coefficients of determination being 0.82, 0.85 and 0.80, respectively. Entrainment tends to reduce temperature, water vapor content and moist static energy in cloud due to evaporative cooling and dilution. Inspection of the relationships between entrainment rate and microphysical properties reveals a negative correlation between volume-mean radius and entrainment rate, suggesting the potential dominance of homogeneous mechanism in the clouds examined. The entrainment rate and environmental water vapor content show similar tendencies of variation with the distance of the assumed environmental air to the cloud edges. Their variation tendencies are non-monotonic due to the relatively short distance between adjacent clouds.

  5. Effect of static electronic advertising signs on road safety: an experimental case study.

    PubMed

    Izadpanah, Pedram; Omrani, Reza; Koo, Sheldon; Hadayeghi, Ali

    2014-01-01

    As technology continues to advance, the outdoor advertising industry is taking advantage of electronic signs, some of which are static electronic signs (SES), with the ability to automatically change the message shown on the sign at regular intervals. Studies indicate that SES has a negative impact on the drivers' visual attention and on vehicle control. However, the actual effects of the SES on the number of collisions have been difficult to prove conclusively. The objective of this article is to generate a clear understanding of the safety impacts of SES on the number collisions by conducting a before-and-after analysis with comparison groups. The analysis was based on a total of 10 SES along the Highway 27 and the Gardiner Expressway of the city of Toronto. The results of the before-and-after study revealed that there was not enough evidence to suggest that these signs have any impact on road safety along the adjacent roadway sections at a 95% confidence interval. The same results were obtained by comparing collisions that occurred during daylight and artificial light.

  6. The Long Range Reconnaissance and Observation System (LORROS) with the Kollsman, Inc. Model LH-40, Infrared (Erbium) Laser Rangefinder hazard analysis and safety assessment.

    SciTech Connect

    Augustoni, Arnold L.

    2004-09-01

    A laser hazard analysis and safety assessment was performed for the LH-40 IR Laser Rangefinder based on the 2000 version of the American National Standard Institute's Standard Z136.1, for the Safe Use of Lasers and Z136.6, for the Safe Use of Lasers Outdoors. The LH-40 IR Laser is central to the Long Range Reconnaissance and Observation System (LORROS). The LORROS is being evaluated by the Department 4149 Group to determine its capability as a long-range assessment tool. The manufacture lists the laser rangefinder as 'eye safe' (Class 1 laser classified under the CDRH Compliance Guide for Laser Products and 21 CFR 1040 Laser Product Performance Standard). It was necessary that SNL validate this prior to its use involving the general public. A formal laser hazard analysis is presented for the typical mode of operation.

  7. Conceptual design study of Fusion Experimental Reactor (FY86 FER): Safety

    NASA Astrophysics Data System (ADS)

    Seki, Yasushi; Iida, Hiromasa; Honda, Tsutomu

    1987-08-01

    This report describes the study on safety for FER (Fusion Experimental Reactor) which has been designed as a next step machine to the JT-60. Though the final purpose of this study is to have an image of design base accident, maximum credible accident and to assess their risk or probability, etc., as FER plant system, the emphasis of this years study is placed on fuel-gas circulation system where the tritium inventory is maximum. The report consists of two chapters. The first chapter summarizes the FER system and describes FMEA (Failure Mode and Effect Analysis) and related accident progression sequence for FER plant system as a whole. The second chapter of this report is focused on fuel-gas circulation system including purification, isotope separation and storage. Probability of risk is assessed by the probabilistic risk analysis (PRA) procedure based on FMEA, ETA and FTA.

  8. Application of a model for delivering occupational safety and health to smaller businesses: Case studies from the US

    PubMed Central

    Cunningham, Thomas R.; Sinclair, Raymond

    2015-01-01

    Smaller firms are the majority in every industry in the US, and they endure a greater burden of occupational injuries, illnesses, and fatalities than larger firms. Smaller firms often lack the necessary resources for effective occupational safety and health activities, and many require external assistance with safety and health programming. Based on previous work by researchers in Europe and New Zealand, NIOSH researchers developed for occupational safety and health intervention in small businesses. This model was evaluated with several intermediary organizations. Four case studies which describe efforts to reach small businesses with occupational safety and health assistance include the following: trenching safety training for construction, basic compliance and hazard recognition for general industry, expanded safety and health training for restaurants, and fall prevention and respirator training for boat repair contractors. Successful efforts included participation by the initiator among the intermediaries’ planning activities, alignment of small business needs with intermediary offerings, continued monitoring of intermediary activities by the initiator, and strong leadership for occupational safety and health among intermediaries. Common challenges were a lack of resources among intermediaries, lack of opportunities for in-person meetings between intermediaries and the initiator, and balancing the exchanges in the initiator–intermediary–small business relationships. The model offers some encouragement that initiator organizations can contribute to sustainable OSH assistance for small firms, but they must depend on intermediaries who have compatible interests in smaller businesses and they must work to understand the small business social system. PMID:26300585

  9. Application of a model for delivering occupational safety and health to smaller businesses: Case studies from the US.

    PubMed

    Cunningham, Thomas R; Sinclair, Raymond

    2015-01-01

    Smaller firms are the majority in every industry in the US, and they endure a greater burden of occupational injuries, illnesses, and fatalities than larger firms. Smaller firms often lack the necessary resources for effective occupational safety and health activities, and many require external assistance with safety and health programming. Based on previous work by researchers in Europe and New Zealand, NIOSH researchers developed for occupational safety and health intervention in small businesses. This model was evaluated with several intermediary organizations. Four case studies which describe efforts to reach small businesses with occupational safety and health assistance include the following: trenching safety training for construction, basic compliance and hazard recognition for general industry, expanded safety and health training for restaurants, and fall prevention and respirator training for boat repair contractors. Successful efforts included participation by the initiator among the intermediaries' planning activities, alignment of small business needs with intermediary offerings, continued monitoring of intermediary activities by the initiator, and strong leadership for occupational safety and health among intermediaries. Common challenges were a lack of resources among intermediaries, lack of opportunities for in-person meetings between intermediaries and the initiator, and balancing the exchanges in the initiator-intermediary-small business relationships. The model offers some encouragement that initiator organizations can contribute to sustainable OSH assistance for small firms, but they must depend on intermediaries who have compatible interests in smaller businesses and they must work to understand the small business social system.

  10. Study on development and application of platform with students' safety based on SOA

    NASA Astrophysics Data System (ADS)

    Jiang, Derong

    2011-10-01

    Students' safety management is a very important work, which is responsible for the entire school student security problems, student safety primarily prevent, only advance predict various of the imminent problems, to better protect their safety. The system mainly used on the development request the student safety management, safety evaluation, safety education, and etc, which are for daily management work completed for students in the security digital management. Development of the system can reduce the safety management for department working pressure, meanwhile, can reduce the labor force to use, accelerate query speed, strengthens the management, as well as the national various departments about the information step, making each management standardized. Therefore, developing a set of suitability and the populace, compatibly good system is very necessary.

  11. Multicenter Observational Study of the First-Generation Intravenous Blood Glucose Monitoring System in Hospitalized Patients

    PubMed Central

    Bochicchio, Grant V.; Hipszer, Brian R.; Magee, Michelle F.; Bergenstal, Richard M.; Furnary, Anthony P.; Gulino, Angela M.; Higgins, Michael J.; Simpson, Peter C.; Joseph, Jeffrey I.

    2015-01-01

    Background: Current methods of blood glucose (BG) monitoring and insulin delivery are labor intensive and commonly fail to achieve the desired level of BG control. There is great clinical need in the hospital for a user-friendly bedside device that can automatically monitor the concentration of BG safely, accurately, frequently, and reliably. Methods: A 100-patient observation study was conducted at 6 US hospitals to evaluate the first generation of the Intravenous Blood Glucose (IVBG) System (Edwards Lifesciences LLC & Dexcom Inc). Device safety, accuracy, and reliability were assessed. A research nurse sampled blood from a vascular catheter every 4 hours for ≤ 72 hours and BG concentration was measured using the YSI 2300 STAT Plus Analyzer (YSI Life Sciences). The IVBG measurements were compared to YSI measurements to calculate point accuracy. Results: The IVBG systems logged more than 5500 hours of operation in 100 critical care patients without causing infection or inflammation of a vein. A total of 44135 IVBG measurements were performed in 100 patients with 30231 measurements from the subset of 75 patients used for accuracy analysis. In all, 996 IVBG measurements were time-matched with reference YSI measurements. These pairs had a mean absolute difference (MAD) of 11.61 mg/dl, a mean absolute relative difference (MARD) of 8.23%, 93% met 15/20% accuracy defined by International Organization for Standardization 15197:2003 standard, and 93.2% were in zone A of the Clarke error grid. The IVBG sensors were exposed to more than 200 different medications with no observable effect on accuracy. Conclusions: The IVBG system is an automated and user-friendly glucose monitoring system that provides accurate and frequent BG measurements with great potential to improve the safety and efficacy of insulin therapy and BG control in the hospital, potentially leading to improved clinical outcomes. PMID:26033922

  12. Pig models of neurodegenerative disorders: Utilization in cell replacement-based preclinical safety and efficacy studies.

    PubMed

    Dolezalova, Dasa; Hruska-Plochan, Marian; Bjarkam, Carsten R; Sørensen, Jens Christian H; Cunningham, Miles; Weingarten, David; Ciacci, Joseph D; Juhas, Stefan; Juhasova, Jana; Motlik, Jan; Hefferan, Michael P; Hazel, Tom; Johe, Karl; Carromeu, Cassiano; Muotri, Alysson; Bui, Jack; Strnadel, Jan; Marsala, Martin

    2014-08-15

    An important component for successful translation of cell replacement-based therapies into clinical practice is the utilization of large animal models to conduct efficacy and/or safety cell dosing studies. Over the past few decades, several large animal models (dog, cat, nonhuman primate) were developed and employed in cell replacement studies; however, none of these models appears to provide a readily available platform to conduct effective and large-scale preclinical studies. In recent years, numerous pig models of neurodegenerative disorders were developed using both a transgenic approach as well as invasive surgical techniques. The pig model (naïve noninjured animals) was recently used successfully to define the safety and optimal dosing of human spinal stem cells after grafting into the central nervous system (CNS) in immunosuppressed animals. The data from these studies were used in the design of a human clinical protocol used in amyotrophic lateral sclerosis (ALS) patients in a Phase I clinical trial. In addition, a highly inbred (complete major histocompatibility complex [MHC] match) strain of miniature pigs is available which permits the design of comparable MHC combinations between the donor cells and the graft recipient as used in human patients. Jointly, these studies show that the pig model can represent an effective large animal model to be used in preclinical cell replacement modeling. This review summarizes the available pig models of neurodegenerative disorders and the use of some of these models in cell replacement studies. The challenges and potential future directions in more effective use of the pig neurodegenerative models are also discussed.

  13. Subchronic oral toxicity and cardiovascular safety pharmacology studies of resveratrol, a naturally occurring polyphenol with cancer preventive activity

    PubMed Central

    Johnson, W.D.; Morrissey, R.L.; Usborne, A.L.; Kapetanovic, I.; Crowell, J.A.; Muzzio, M.; McCormick, D.L.

    2011-01-01

    To characterize the subchronic oral toxicity of resveratrol, CD rats received daily gavage doses of 0, 200, 400, or 1000 mg resveratrol/kg/day, and beagle dogs received daily capsule doses of 0, 200, 600, or 1200 mg resveratrol/kg/day for 90 days. Resveratrol induced only minimal toxicity, consisting of dose-related reductions in body weight gain in female rats and both sexes of dogs, and a statistically significant increase in bilirubin levels in rats at the 1000 mg/kg/day dose. Clinical observations, hematology, ophthalmology, neurotoxicity evaluations (functional observational batteries), organ weights, and gross pathology provided no biologically significant evidence of resveratrol toxicity in either species. In rats, the high dose of resveratrol reduced the incidence of cardiomyopathy; no other microscopic changes were seen. Histopathologic changes in dogs were limited to minimal inflammatory infiltrates in the kidney and urinary bladder, which were not considered toxicologically significant. A cardiovascular safety pharmacology (telemetry) study in dogs revealed no evidence of resveratrol toxicity. Based on body weight effects, the No Observed Adverse Effect Level (NOAEL) for resveratrol was 200 mg/kg/day in rats and 600 mg/kg/day in dogs. The apparent cardioprotective activity of resveratrol in rats demonstrates that its potentially beneficial activities may extend beyond efficacy in cancer prevention. PMID:21939727

  14. Safety of administering the canine melanoma DNA vaccine (Oncept) to cats with malignant melanoma - a retrospective study.

    PubMed

    Sarbu, Luminita; Kitchell, Barbara E; Bergman, Philip J

    2017-02-01

    Objectives A xenogeneic human tyrosinase DNA vaccine was developed for treatment of dogs with oral malignant melanoma (Oncept; Merial). No studies have evaluated the safety or efficacy of this vaccine in cats. The purpose of this study was to evaluate the safety of the canine melanoma vaccine in cats diagnosed with melanoma. Methods Medical records were reviewed from cats diagnosed with malignant melanoma and treated with the canine melanoma DNA vaccine (Oncept). Data regarding signalment, melanoma location, treatments received, vaccine adverse effects and cause of death were collected. Results A total of 114 melanoma vaccines were administered to 24 cats. Seven cats (11.4%) had clinical adverse effects from a total of 13 vaccines classified as grade 1 or 2 based on the Veterinary Cooperative Oncology Group's common terminology criteria for adverse events v1.1. These included pain on vaccine administration, brief muscle fasciculation, transient inappetence, depression, nausea and mild increase in pigmentation at the injection site. Nineteen cats were deceased at study close. The most common cause of death was melanoma (14 cats). Hematological and biochemical changes were observed in six cats, five of which had concurrent disease or treatments that likely caused or greatly contributed to the laboratory abnormalities found. Therefore, these adverse events were considered unlikely to be caused by the melanoma vaccine. One cat had transient grade 1 hypoalbuminemia, which was possibly caused by the vaccination but not thoroughly evaluated. Conclusions and relevance The canine melanoma DNA vaccine can be safely administered to cats, with minimal risk of adverse effects.

  15. Simulation Study Of Early Afterglows Observed With Swift

    NASA Astrophysics Data System (ADS)

    Nishikawa, Ken-Ichi; Hededal, C.; Hardee, P.; Mizuno, Y.; Fishman, G. J.

    2006-09-01

    A 3-D relativistic particle-in-cell code has been used to simulate the dynamics of forward and reverse shocks with thin and thick shells within the parameter constraints provided by present Swift observations and the present models of GRB emission. Our 3-D RPIC simulations have provided the dynamics of collisionless shocks in electron-ion and electron-positron plasmas with and without initial ambient magnetic fields and revealed the importance of ``jitter radiation'' with prompt and afterglow spectra due to the inhomogeneous magnetic fields generated by the Weibel instability. It is different from synchrotron radiation, which is usually assumed to be the dominant radiation process. We have investigated gamma-ray burst emissions from prompt, early, and late afterglows considering microscopic processes. Based on our previous investigation of the Weibel instability for each stage of evolution of ejecta propagating in the ISM, we have incorporated the plasma conditions (relativistic jets) with the density and composition of the plasmas, the magnetic field strength ($\\sigma$-values (the ratio of the electromagnetic energy flux to the particle energy flux)) and its direction, and the Lorentz factor for the different stages in prompt and afterglows. Systematic simulation studies of the relativistic collisionless shocks, associated particle acceleration, magnetic field generation and self-consistent radiation provide insight into undetermined issues in prompt and afterglows observed by Swift. Self-consistently calculated lightcurves, spectra, spectral evolutions, and polarization as function of viewing angle will be done to light a shed on recent new observations by Swift, in particular, X-ray flares, early steep decay, and shallow decay.

  16. Building Alliances with (In)Voluntary Clients: A Study Focused on Therapists' Observable Behaviors.

    PubMed

    Sotero, Luciana; Cunha, Diana; da Silva, José Tomás; Escudero, Valentín; Relvas, Ana Paula

    2016-11-14

    This study aimed to compare therapists' observable behaviors to promote alliances with involuntary and voluntary clients during brief family therapy. The therapists' contributions to fostering alliances were rated in sessions 1 and 4 using videotapes of 29 families who were observed in brief therapy. Using the System for Observing Family Therapy Alliances, trained raters searched for specific therapist behaviors that contributed to or detracted from the four alliance dimensions: engagement in the therapeutic process, an emotional connection with the therapist, safety within the therapeutic system, and a shared sense of purpose within the family. The results showed that when working with involuntary clients, therapists presented more behaviors to foster the clients' engagement and to promote a shared sense of purpose within the family. However, in the fourth session, the therapists in both groups contributed to the alliance in similar ways. The results are discussed in terms of (a) the therapists' alliance-building behaviors, (b) the specificities of each client group, and (c) the implications for clinical practice, training, and research.

  17. Safety of Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12-supplemented yogurt in healthy adults on antibiotics: a phase I safety study.

    PubMed

    Merenstein, Daniel J; Tan, Tina P; Molokin, Aleksey; Smith, Keisha Herbin; Roberts, Robert F; Shara, Nawar M; Mete, Mihriye; Sanders, Mary Ellen; Solano-Aguilar, Gloria

    2015-01-01

    Probiotics are live microorganisms that, when administered in sufficient doses, provide health benefits on the host. The United States Food and Drug Administration (FDA) requires phase I safety studies for probiotics when the intended use of the product is as a drug. The purpose of the study was to determine the safety of Bifidobacterium animalis subsp lactis (B. lactis) strain BB-12 (BB-12)-supplemented yogurt when consumed by a generally healthy group of adults who were prescribed a 10-day course of antibiotics for a respiratory infection. Secondary aims were to assess the ability of BB-12 to affect the expression of whole blood immune markers associated with cell activation and inflammatory response. A phase I, double-blinded, randomized controlled study was conducted in compliance with FDA guidelines for an Investigational New Drug (IND). Forty participants were randomly assigned to consume 4 ounces of either BB-12 -supplemented yogurt or non-supplemented control yogurt daily for 10 d. The primary outcome was to assess safety and tolerability, assessed by the number of reported adverse events. A total of 165 non-serious adverse events were reported, with no differences between the control and BB-12 groups. When compared to the control group, B lactis fecal levels were modestly higher in the BB-12-supplemented group. In a small subset of patients, changes in whole blood expression of genes associated with regulation and activation of immune cells were detected in the BB-12-supplemented group. BB-12-supplemented yogurt is safe and well tolerated when consumed by healthy adults concurrently taking antibiotics. This study will form the basis for future randomized clinical trials investigating the potential immunomodulatory effects of BB-12-supplemented yogurt in a variety of disease states.

  18. An approach to space weather studies from ground based observations

    NASA Astrophysics Data System (ADS)

    Minarovjech, M.; Rušin, V.; Rybanský, M.; Kudela, K.; Kollár, V.

    2004-10-01

    We use daily values of the green corona hole areas, as prepared from the ground-based observations above the E-limb of the Sun and cosmic ray flux observed at Climax and Huancayo/Haleakala, to study a relation between them during a long-term period. A cross-correlation method has been used in the period 1953-2002 (the end of solar cycle 18 to mid-cycle 23). There were found green coronal hole areas that precede the cosmic ray of 200 - 270 days, with the maximum of 230 days (an average of 8 months). The 27-day rotational periodicity is stored around the maximum of correlation coefficients that reached values of 0.78 and 0.72, respectively. This correlation could be used to forecast the level of the cosmic ray daily flux at neutron monitor energies. We try to explain this behavior in a framework of the total coronal mass and its expansion into the heliosphere.

  19. A Comparative Study of Efficacy and Safety of Agomelatine and Escitalopram in Major Depressive Disorder

    PubMed Central

    Nukala, Srikrishna; Palla, Jayasree; Nambaru, Lakshmana Rao; Kasturi, Satyanarayana Murthy

    2015-01-01

    Background Major depressive disorder (MDD) is a mental disorder characterized by episodes of depressed mood, loss of interest or pleasure, feeling of guilt or low self-esteem, loss of energy, altered sleep patterns and difficulty in concentration. Objective This study was carried out to compare the efficacy and safety of Agomelatine with Escitalopram in the treatment of major depressive disorder. Design and Setting This is a prospective study conducted at Outpatient Department of Psychiatry, GSL Medical College & General hospital, Rajahmundry, India. Materials and Methods Patients with newly diagnosed major depressive disorder (DSM-IV-TR) with minimum score of 20 in Hamilton depression rating scale were randomly assigned Agomelatine (25-50 mg/day) or Escitalopram (10-20 mg/day) for a period of 8 weeks. The main efficacy outcome considered was the mean change of HAM-D17 score from baseline to end of therapy. Secondary outcome measures were Clinical Global Impressions–improvement (CGI) and severity (CGI-S) rating scales. Statistical Analysis Student t-test was used for comparing the groups and chi-square test was used for assessing the qualitative variables. For all statistical analysis p<0.05 was considered statistically significant. Results The drugs under study effectively reduced depressive symptoms at all the time points. The percentage of responders at 8weeks (last post baseline value) was 65.38% with Agomelatine and 57.40% with Escitalopram. The difference between the drugs was statistically not significant in all evaluations (p>0.05). The mean CGI-S and CGI-I scores were decreased in both the groups (p<0.05) and there was no statistically significant difference between the groups at any assessment during the study period. Both the treatment groups showed favourable safety profile. Conclusion The study results supported that Agomelatine is therapeutically similar to Escitalopram in terms of antidepressant effect. PMID:26266196

  20. Migration, violence, and safety among migrant sex workers: a qualitative study in two Guatemalan communities.

    PubMed

    Rocha-Jiménez, Teresita; Brouwer, Kimberly C; Silverman, Jay G; Morales-Miranda, Sonia; Goldenberg, Shira M

    2016-09-01

    Despite reports of high levels of violence among women migrants in Central America, limited evidence exists regarding the health and safety of migrant sex workers in Central America. This study is based on 16 months of field research (November 2012-February 2014), including ethnographic fieldwork, in-depth interviews, and focus groups conducted with 52 internal and international migrant female sex workers in Tecún Umán and Quetzaltenango, Guatemala, key transit and destination communities for both international and internal migrants. The analysis explored migration-related determinants of susceptibility to violence experienced by migrant sex workers across different phases of migration. Violence in home communities and economic considerations were key drivers of migration. Unsafe transit experiences (eg undocumented border crossings) and negative interactions with authorities in destination settings (eg extortion) contributed to migrant sex workers' susceptibility to violence, while enhanced access to information on immigration policies and greater migration and sex work experience were found to enhance agency and resilience. Findings suggest the urgent need for actions that promote migrant sex workers' safety in communities of origin, transit, and destination, and programmes aimed at preventing and addressing human rights violations within the context of migration and sex work.