Science.gov

Sample records for observational safety study

  1. An observational study of safety belt use among taxi drivers in Boston.

    PubMed

    Fernandez, William G; Park, Johnny Lee; Olshaker, Jonathan

    2005-06-01

    Although safety belt legislation exists for drivers in Massachusetts, there is an exemption for taxicab drivers. According to the most recent data from the Governor's Highway Safety Bureau, the observed safety belt use rate of drivers in Massachusetts is 64%. However, the safety belt use among taxicab drivers in Boston is unknown. An observational study was conducted to assess the prevalence of safety belt use among taxicab drivers in Boston. We compared our findings with state-level data obtained from the Governor's Highway Safety Bureau. Research staff made observations of taxicabs arriving at various sites within Boston (Logan Airport, Back Bay subway entrance, Government Center, and a hospital in Boston). The methodology used in this study was adapted from MASS-Safe, the Traffic Safety Research Program of the Governor's Highway Safety Bureau. In brief, research staff assessed the use of shoulder safety belts worn by taxicab drivers in Boston. Researchers observed traffic flow coming from a single direction at each observation site. These observers were instructed to include only taxicabs in motion, approaching in the nearest lane to the sidewalk. Two hundred fifty taxicabs were observed during the study period. Of these, 247 taxicab drivers were men (98.9%), whereas 3 were women (1.2%). Overall, 17 of 250 taxicab drivers (6.8%; 95% confidence interval 3.9% to 9.7%) wore safety belts, whereas 233 (93.2%) did not. The safety belt use among taxicab drivers in Boston is 6.8%, markedly lower than the state-level safety belt use of other drivers in Massachusetts. Stronger safety belt use legislation in Massachusetts may help to improve safety belt use among taxi drivers in Boston.

  2. 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

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

    PubMed

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

    2016-10-01

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

  4. An observational study of child safety seat use in an international safe community: Tehran, Iran.

    PubMed

    Moradi, Marziyeh; Khanjani, Narges; Nabipour, Amir Reza

    2017-01-02

    Despite strong evidence of the effectiveness of child safety seats in reducing injuries, the use of these devices in some communities is still rare. The purpose of this study was to determine the prevalence of child safety seat use and the factors influencing its use in the safe community of Tehran. This roadside observational study was conducted in 2015 and 2,178 personal cars with a child under 12 years aboard were observed on Tehran's streets in regard to use of child safety seats. Other variables such as the gender of the driver, driver's age group, type of street, region of municipality, time of day, and day of the week were also collected. Prevalence of child safety seat use was 4.3% and was significantly higher among women drivers, on freeways, and in municipal regions 1, 4, and 7. The prevalence of child safety seat use in Tehran as a most populous member of the international safe community was very low and most children commuted in insecure situations in the vehicle. Therefore, it is proposed that plans should be made to increase the use of child safety seats in international safe communities.

  5. 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

  6. 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

  7. Characteristics of safety information obtained from postmarketing observational studies for re-examination in Japan.

    PubMed

    Watanabe, Tatsuya; Narukawa, Mamoru

    2016-01-01

    In Japan, postmarketing surveillance (PMS) studies are required for newly approved drug products to further collect safety information in clinical settings. "PMS study" is a general term encompassing both postmarketing observational (PMO) studies and postmarketing intervention studies for re-examination. Each PMS study is conducted under contracts between the pharmaceutical company and medical institutions in accordance with Good Postmarketing Study Practice. It has been reported that the safety information collected postmarketing is limited because of underreporting. The objective of this investigation was to identify differences among profiles of the drug product safety information collected through intervention studies and observational studies before and after approval. Our study addressed whether the issue of underreporting, generally considered as associated with observational studies, occurs in PMO studies for re-examination. In addition, we considered potential causes of such underreporting. The overall adverse reaction rate was lower in PMO studies than in intervention studies before approval in almost all cases. The adverse reaction rate in intervention studies exhibited similar profiles regardless of whether they were conducted prior to or following approval. In addition, we found that one reason for a lower adverse reaction rate in PMO studies was that the number of reports of adverse reactions that had occurred frequently prior to approval decreased postmarketing. Underreporting was observed even in PMO studies for re-examination under the Japanese regulation. Although it was suggested that expected and common adverse reactions were more likely to be subject to underreporting, further investigation is warranted to explore the reasons for the under-reporting in PMO studies.

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

    PubMed

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

    2015-12-11

    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. 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. 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-reviewed, scientific journals, and presented at academic conferences. This study

  9. 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

  10. 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

  11. Utilisation and Safety of Deferasirox: Results from an Observational Cohort Study in England.

    PubMed

    Osborne, Vicki; Davies, Miranda; Layton, Deborah; Shakir, Saad A W

    2017-10-10

    Deferasirox (EXJADE(®), Novartis, UK) is an oral iron-chelating agent primarily used to reduce chronic iron overload in patients receiving blood transfusions for various chronic anaemias and some non-transfusion dependant anaemias. The aim of this study was to examine the utilisation and safety of deferasirox used in general practice in England. A single exposure observational cohort study design was used. Patients were identified from dispensed prescriptions for deferasirox between September 2006 and September 2014. Outcome data were collected via postal questionnaires sent to prescribers ≥ 6 months after first dispensed prescription for an individual patient. Summary descriptive statistics were calculated. The evaluable cohort consisted of 122 patients, of which 41.8% were aged 2-17 years. Frequent reasons for prescribing were sickle cell anaemia (27/103 where specified, 26.2%) and beta thalassaemia (26, 25.2%). The majority of patients (43/51, 84.3%) were prescribed the licensed doses of 10 or 20 mg/kg/day at start. Prior measurements of serum creatinine were only reported for a small proportion this study (18/122, 14.8%). In total, 91 incident events were reported, including two of raised serum creatinine. These results show that deferasirox is largely being prescribed for its licensed indications in general practice in England and events reported were consistent with the known safety profile.

  12. 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

  13. Do daily ward interviews improve measurement of hospital quality and safety indicators? A prospective observational study.

    PubMed

    Sarkies, Mitchell N; Bowles, Kelly-Ann; Skinner, Elizabeth H; Haas, Romi; Mitchell, Deb; O'Brien, Lisa; May, Kerry; Ghaly, Marcelle; Ho, Melissa; Haines, Terry P

    2016-10-01

    The aim of this study was to determine if the addition of daily ward interview data improves the capture of hospital quality and safety indicators compared with incident reporting systems alone. An additional aim was to determine the potential characteristics influencing under-reporting of hospital quality and safety indicators in incident reporting systems. A prospective, observational study was performed at two tertiary metropolitan public hospitals. Research assistants from allied health backgrounds met daily with the nurse in charge of the ward and discussed the occurrence of any falls, pressure injuries and rapid response medical team calls. Data were collected from four general medical wards, four surgical wards, an orthopaedic, neurosciences, plastics, respiratory, renal, sub-acute and acute medical assessment unit. An estimated total of 303 falls, 221 pressure injuries and 884 rapid response medical team calls occurred between 15 wards across two hospitals, over a period of 6 months. Hospital incident reporting systems underestimated falls by 30.0%, pressure injuries by 59.3% and rapid response medical team calls by 17.0%. The use of ward interview data collection in addition to hospital incident reporting systems improved data capture of falls by 23.8% (n = 72), pressure injuries by 21.7% (n = 48) and rapid response medical team calls by 12.7% (n = 112). Falls events were significantly less likely to be reported if they occurred on a Monday (P = 0.04) and pressure injuries significantly more likely to be reported if they occurred on a Wednesday (P = 0.01). Hospital quality and safety indicators (falls, pressure injuries and rapid response medical team calls) were under-reported in incident reporting systems, with variability in under-reporting between wards and the day of event occurrence. The use of ward interview data collection in addition to hospital incident reporting systems improved reporting of hospital quality and safety

  14. 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.

  15. 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

  16. 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…

  17. 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…

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

    PubMed Central

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

    2014-01-01

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

  19. 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.

  20. Effectiveness and safety of collagenase Clostridium histolyticum in Dupuytren's disease : an observational study in Belgium.

    PubMed

    Verstreken, F; Degreef, I; Decramer, A; Libberecht, K; Vanhove, W; Datco, A; Vanhaecke, J; Clermont, D; Duerinckx, J

    2016-08-01

    Dupuytren's disease is a connective tissue disorder leading to contractures. It can be treated surgically or through injections of collagenase Clostridium histolyticum (CCH). Patients with Dupuytren's contracture (> 20°) and a palpable cord were included in this observational study, aiming to characterise the Belgian patient population and to assess the effectiveness and safety of CCH. Overall, 108 patients (114 joints) received at least one injection of CCH, and 104 patients completed the study. The percentages of joints achieving a degree of contracture of 5° or less, or a relative contracture reduction of at least 50% after the extension procedure were 64.9% and 90.1%, respectively. The mean number of injections per cord was 1.0. The Unité Rhumatologique des Affections de la Main score decreased from 29.4 ± 11.0 to 12.9 ± 6.3 (mean ± SD ; p < 0.0001). CCH was demonstrated to be effective, safe and able to increase quality of life.

  1. Observational study of safety and efficacy of varenicline for smoking cessation among Filipino smokers.

    PubMed

    Park, Peter W; Casiano, Errol M; Escoto, Laarni; Claveria, Angelica M

    2011-10-01

    Varenicline, an α4β2 receptor nicotinic receptor partial agonist, is known to be an effective aid for smoking cessation. To date, few observational studies of varenicline have been conducted. This prospective, non-interventional, post-marketing surveillance study (NCT00794365) was designed to monitor the efficacy and safety of varenicline for 12 weeks in Filipino smokers who were motivated to quit. This study was conducted between July 2, 2008, and November 23, 2009, in 70 centers throughout the Philippines. Participants were adult smokers who were prescribed varenicline (0.5 mg orally once daily, days 1 to 3; 0.5 mg twice daily, days 4 to 7; 1 mg twice daily for the remainder of a 12-week treatment period) for the first time. Participants made five clinic visits (weeks 0, 1, 4, 8, and 12). Adverse events (AEs) were recorded at each clinic visit and up to 28 days after administration of the last study treatment. Seven-day point prevalence of smoking cessation was measured at weeks 4, 8, and 12. A total of 330 participants were enrolled into the study, of whom 251 (76.1%) completed the study. At the end of week 12, 57.6% (95% confidence interval, 52.0, 63.0) of participants had been abstinent for the previous 7 days. The most frequently reported AEs were headache (5.5%), dizziness (3.9%), and nausea (3.6%). Ten participants (3.0%) permanently discontinued varenicline treatment due to AEs, and 13 (3.9%) reduced their varenicline dose or discontinued treatment temporarily due to AEs. There were no reports of any serious AEs, deaths, suicidal ideation, or behavior. The results of this study in adult Filipino smokers prescribed varenicline for the first time during routine clinical practice demonstrate that varenicline was well tolerated and efficacious as an aid for smoking cessation.

  2. 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.

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed

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

    2013-01-01

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

  5. 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

  6. An observational study of the safety benefits of electronic logging devices using carrier-collected data.

    PubMed

    Hickman, Jeffrey S; Guo, Feng; Camden, Matthew C; Dunn, Naomi J; Hanowski, Richard J

    2017-04-03

    Fatigue has been shown to be a contributing factor in many large truck crashes. Long duty periods, irregular work schedules, and poor sleeping environments make fatigue a noteworthy concern in trucking operations. One way to limit fatigued driving is through prescriptive hours-of-service (HOS) regulations. This duty status information is typically recorded in written logs; however, more trucking companies are moving toward electronic HOS recorders. These devices were first marketed as productivity tools; however, more recently they have been touted for their safety benefits in reducing fatigued truck drivers (because falsifying electronic logs is difficult). The purpose of the current study was to assess the benefits of electronic logging devices (ELDs) on safety and HOS violations in trucks as they operated during normal revenue service. Data on crashes, HOS violations, mileage, and onboard safety systems were obtained from participating motor carriers. Although the final data sets included data from 11 carriers representing medium and large carriers (including a total of 82,943 crashes, 970 HOS violations, and 224,034 truck-years that drove a total of 15.6 billion miles), the data set in the study was skewed toward larger, for-hire carriers and may not represent the overall U.S. trucking population. After controlling for calendar year, carriers in the data set, onboard safety system status, and long-haul/regional indicator, ELD-equipped trucks had a significantly lower total crash rate (11.7% reduction), preventable crash rate (5.1% reduction), driving-related HOS violation rate (53% reduction), and non-driving-related HOS violation rate (49% reduction) than trucks not equipped with ELDs. The results show a clear safety benefit, in terms of crash and HOS violation reductions, for trucks equipped with ELDs.

  7. An observational study of road safety around selected primary schools in Ibadan municipality, Oyo State, Southwestern Nigeria.

    PubMed

    Sangowawa, Adesola O; Adebiyi, Akindele O; Faseru, Babalola; Popoola, Olusola J

    2012-01-01

    Child pedestrians have been identified as vulnerable road users. Although walking as a means of transport has health and other benefits, it exposes children to the risk of road traffic injuries. This study was conducted to assess the availability of road safety features around government-owned primary schools in Ibadan municipality. A multistage sampling technique was used to select 46 of the 74 schools in the study area. Some (11) of the selected schools were sited within the same premises and shared a common entrance; thus a total of 35 school premises were eventually observed. Trained research assistants observed the school environment around the selected schools for road safety features such as location of schools, presence of "school", "child crossing" and "speed limit" road signs, and presence of traffic calming devices (road bumps or zebra crossing). Five (14%) of the schools were located on major roads and eight (23%) had road signs indicating that a school was nearby. Seven (20%) had road bumps close to the school, 15 (43%) had a warden who assisted children to cross, and none had a zebra crossing. Five (14%) schools had pedestrian sidewalks. The study revealed that the environment around a number of the observed schools in the municipality compromised the pupils' road safety. The local government, school authorities, parents, and road safety professionals need to institute definite measures to enhance the road safety environment around schools in the municipality.

  8. The effects of roundabouts on traffic safety for bicyclists: an observational study.

    PubMed

    Daniels, Stijn; Nuyts, Erik; Wets, Geert

    2008-03-01

    A before-and-after study was carried out of injury accidents involving bicyclists on 91 roundabouts in Flanders-Belgium. The study design accounted for the effects of general safety trends and regression-to-the-mean, but could not take into account the possibility of specific changes in traffic volume at roundabouts. The conversion of intersections into roundabouts produces a significant 27% increase in the number of injury accidents involving bicyclists on or nearby the roundabouts. The increase is even higher for accidents involving fatal or serious injuries (41-46%). Compared to the proven favourable effects of roundabouts on safety in general, this result is unexpectedly poor. However, the effects of roundabouts on bicycle accidents differ depending on whether these roundabouts are built inside or outside built-up areas. When inside built-up areas, the construction of roundabouts increased the number of injury accidents involving bicyclists by 48%. For accidents causing fatal or serious injuries inside built-up areas, an average increase of 77% was found. However, outside built-up areas the zero-hypothesis of 'no safety effect for bicyclists' cannot be rejected (best estimate: +1% accidents, not significant). Roundabouts that replace traffic signals perform worse when compared to roundabouts at other types of intersections.

  9. Errors in the management of cardiac arrests: an observational study of patient safety incidents in England.

    PubMed

    Panesar, Sukhmeet S; Ignatowicz, Agnieszka M; Donaldson, Liam J

    2014-12-01

    The aim of this qualitative study is to better understand the types of error occurring during the management of cardiac arrests that led to a death. All patient safety incidents involving management of cardiac arrests and resulting in death which were reported to a national patient safety database over a 17-month period were analysed. Structured data from each report were extracted and these together with the free text, were subjected to content analysis which was inductive, with the coding scheme emerged from continuous reading and re-reading of incidents. There were 30 patient safety incidents involving management of cardiac arrests and resulting in death. The reviewers identified a main shortfall in the management of each cardiac arrest and this resulted in 12 different factors being documented. These were grouped into four themes that highlighted systemic weaknesses: miscommunication involving crash number (4/30, 13%), shortfalls in staff attending the arrest (4/30, 13%), equipment deficits (11/30, 36%), and poor application of knowledge and skills (11/30, 37%). The factors identified represent serious shortfalls in the quality of response to cardiac arrests resulting in death in hospital. No firm conclusion can be drawn about how many deaths in the study population would have been averted if the emergency had been managed to a high standard. The effective management of cardiac arrests should be considered as one of the markers of safe care within a healthcare organisation.

  10. 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.

  11. 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.

  12. 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%. Copyright © 2012 Elsevier Ltd. All rights reserved.

  13. A work observation study of nuclear medicine technologists: interruptions, resilience and implications for patient safety

    PubMed Central

    Larcos, George; Prgomet, Mirela; Georgiou, Andrew; Westbrook, Johanna

    2017-01-01

    Background Errors by nuclear medicine technologists during the preparation of radiopharmaceuticals or at other times can cause patient harm and may reflect the impact of interruptions, busy work environments and deficient systems or processes. We aimed to: (a) characterise the rate and nature of interruptions technologists experience and (b) identify strategies that support safety. Methods We performed 100 hours of observation of 11 technologists at a major public hospital and measured the proportions of time spent in eight categories of work tasks, location of task, interruption rate and type and multitasking (tasks conducted in parallel). We catalogued specific safety-oriented strategies used by technologists. Results Technologists completed 5227 tasks and experienced 569 interruptions (mean, 4.5 times per hour; 95% CI 4.1 to 4.9). The highest interruption rate occurred when technologists were in transit between rooms (10.3 per hour (95% CI 8.3 to 12.5)). Interruptions during radiopharmaceutical preparation occurred a mean of 4.4 times per hour (95% CI 3.3 to 5.6). Most (n=426) tasks were interrupted once only and all tasks were resumed after interruption. Multitasking occurred 16.6% of the time. At least some interruptions were initiated by other technologists to convey important information and/or to render assistance. Technologists employed a variety of verbal and non-verbal strategies in all work areas (notably in the hot-lab) to minimise the impact of interruptions and optimise the safe conduct of procedures. Although most were due to individual choices, some strategies reflected overt or subliminal departmental policy. Conclusions Some interruptions appear beneficial. Technologists' self-initiated strategies to support safe work practices appear to be an important element in supporting a resilient work environment in nuclear medicine. PMID:27707869

  14. 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

  15. 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.

  16. Safety and efficacy of pirfenidone in severe Idiopathic Pulmonary Fibrosis: A real-world observational study.

    PubMed

    Tzouvelekis, Argyrios; Ntolios, Paschalis; Karampitsakos, Theodoros; Tzilas, Vasilios; Anevlavis, Stavros; Bouros, Evangelos; Steiropoulos, Paschalis; Koulouris, Nikolaos; Stratakos, Grigoris; Froudarakis, Marios; Bouros, Demosthenes

    2017-10-01

    Pirfenidone is a novel anti-fibrotic drug that has shown efficacy in five randomized multicenter clinical trials enrolling patients with Idiopathic Pulmonary Fibrosis of mild-to-moderate disease severity. Scarce data supports the use of pirfenidone in IPF patients with more advanced disease. To investigate the safety and efficacy profile of pirfenidone in IPF patients with severe lung function impairment. This was a retrospective study enrolling patients with advanced IPF (FVC%predicted < 50% and/or (DLco%predicted <35%) receiving pirfenidone for at least 6 months. Between September 2011 and March 2013, we identified 43 patients with severe IPF (baseline meanFVC%predicted±SD: 63.8 ± 20.3, meanDLCO%predicted: 27.3 ± 8.2), of mean age±SD: 66.3 + 9.7, 34 males (81%) that received pirfenidone (2.403 mg/daily) for one year. Pirfenidone treatment was associated with a trend towards decrease in functional decline compared to 6-months before treatment initiation but failed to show any benefit after one year of treatment (ΔFVC: -3.3 ± 4.6 vs 0.49 ± 11.4 and vs. -5.8 ± 11.8, p = 0.06 and p = 0.04, respectively and ΔDLCO: -13.3 ± 15.2 vs. -10.1 ± 16.6 and vs. 28.3 ± 19.2, p = 0.39 and p = 0.002, respectively). Gastrointestinal disorders (34.9%), fatigue (23.2%) and photosensitivity (18.6%) were the most common adverse events. Adverse events led to treatment discontinuation in 9 patients (20.9%) and dose reduction in 14 (32.5%). Pirfenidone appears to be safe when administered in patients with advanced IPF. Pirfenidone efficacy in IPF patients with severe lung function impairment may diminish after 6 months of treatment. Copyright © 2017 Elsevier Ltd. All rights reserved.

  17. 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

  18. An observational study on safety and efficacy of povidone-iodine for pleurodesis in cancer patients

    PubMed Central

    Makkar, Ayush; Patni, Sanjeev; Joad, Anjum Khan; Lakhera, Kamal Kishor

    2017-01-01

    Introduction: Pleurodesis is a time-honored procedure for malignant effusion as one of the palliative procedures to treat recurrent effusions. Various agents have been used in the past such as tetracycline, talc, bleomycin, and povidone-iodine. This paper aims at evaluating safety and efficacy of povidone-iodine for the procedure. Materials and Methods: One hundred and four patients underwent of pleurodesis with povidone-iodine done at our center for malignant effusion between June 2008 and August 2015. The safety and efficacy of the procedure was analyzed. Results: One hundred and four patients of malignant effusion with mean age of 53 years and a mean follow-up of 7.8 months were evaluated. A total of 79% patients did not show any reaccumulation of fluid in their follow-up. There was no periprocedural mortality. Eight patients had severe pain; eleven patients had fever, while one patient had arrhythmia. Conclusion: Povidone-iodine is a simple, cheap, and effective method of pleurodesis with no major complication and a high success rate. PMID:28702414

  19. The European post-marketing observational sertindole study: an investigation of the safety of antipsychotic drug treatment.

    PubMed

    Kasper, Siegfried; Möller, Hans-Jürgen; Hale, Anthony

    2010-02-01

    The objective of the European Post-marketing Observational Serdolect((R)) (EPOS) Study was to compare the safety of treatment with Serdolect (sertindole) with that of usual treatment in patients with schizophrenia, in normal European clinical practice. The EPOS was a multicentre, multinational, referenced, cohort study. Patients were enrolled at 226 centres in ten European countries. The study was prematurely terminated in 1998 as a result of the temporary market suspension of sertindole. Termination of the study reduced the number of patients recruited from the planned 12,000 to 2,321. While the power of the study was weakened, it did provide useful mortality information, which may be useful for future long-term studies. Crude mortality in the sertindole and non-sertindole groups was 1.45 (95% confidence interval, CI 0.53-3.16) and 1.50 (CI 0.72-2.76) deaths/100 patient-years exposed, respectively. There were no more cardiac deaths in the sertindole group than in the non-sertindole group. QT interval prolongation did not translate into an increased risk of death. Sertindole was well tolerated and caused few extrapyramidal symptoms. Although CIs remained large, this post-marketing study does not provide any evidence against the use of sertindole under normal conditions. Sertindole was well tolerated and posed no significant safety problems.

  20. Evaluation of clinical safety of conversion to Advagraf therapy in liver transplant recipients: observational study.

    PubMed

    Marin-Gomez, L M; Gomez-Bravo, M A; Alamo-Martinez, J A; Barrera-Pulido, L; Bernal Bellido, C; Suárez Artacho, G; Pascasio, J M

    2009-01-01

    To present the correlation between dosage and plasma concentration of tacrolimus and the consequences for short-term hepatorenal function of conversion to Advagraf (tacrolimus extended-release capsules) in liver transplant recipients. This observational study on adult liver transplant recipients examined tacrolimus levels after conversion to Advagraf therapy. Mean (SD) patient age was 51 (44-59) years. Conversion occurred at 43 (19-85) months posttransplantation, and follow-up was 193 (106.5-243.25) days. Dosage was adjusted milligram for milligram. Levels of tacrolimus, total bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, alkaline phosphatase, and creatinine were recorded on the day before conversion to Advagraf and 1, 3, 6, and months afterward. Of the 79 patients in whom therapy was converted to Advagraf, 31 (39.2%) had alcoholic cirrhosis, 19 (24.1%) had viral disease, 10 (12.7) had mixed disease, 8 (10.1%) had cholestatic disease, 4 (5.1%) had metabolic disease, and 7 (8.8%) had other diseases. Despite no modification of Advagraf dosage during follow-up in most patients, mean tacrolimus levels decreased from the first month after conversion; however, at 6 months after conversion, they tended to equal the initial value. Renal function and liver biochemistry values demonstrated no significant change during follow-up. Although tacrolimus levels decreased initially after conversion to Advagraf therapy, 1:1 conversion is safe for hepatorenal function in liver transplant recipients.

  1. National observational study of prescription dispensing accuracy and safety in 50 pharmacies.

    PubMed

    Flynn, Elizabeth Allan; Barker, Kenneth N; Carnahan, Brian J

    2003-01-01

    To measure dispensing accuracy rates in 50 pharmacies located in 6 cities across the United States and describe the nature and frequency of the errors detected. Cross-sectional descriptive study. Chain, independent, and health-system pharmacies (located in hospitals or managed care organizations). Pharmacy staff at randomly selected pharmacies in each city who accepted an invitation to participate. Observation by a pharmacist in each pharmacy for 1 day, with a goal of inspecting 100 prescriptions for dispensing errors (defined as any deviation from the prescriber's order). Dispensing errors on new and refill prescriptions. Data were collected between July 2000 and April 2001. The overall dispensing accuracy rate was 98.3% (77 errors among 4,481 prescriptions; range, 87.2%-100.0%; 95.0% confidence interval, +/- 0.4%). Accuracy rates did not differ significantly by pharmacy type or city. Of the 77 identified errors, 5 (6.5%) were judged to be clinically important. Dispensing errors are a problem on a national level, at a rate of about 4 errors per day in a pharmacy filling 250 prescriptions daily. An estimated 51.5 million errors occur during the filling of 3 billion prescriptions each year.

  2. 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

  3. The real-world effectiveness and safety of fingolimod in relapsing-remitting multiple sclerosis patients: An observational study.

    PubMed

    Izquierdo, Guillermo; Damas, Fátima; Páramo, Maria Dolores; Ruiz-Peña, Juan Luis; Navarro, Guillermo

    2017-01-01

    Fingolimod approval was based mainly on two clinical trials, FREEDOMS and TRANSFORMS, which demonstrated the efficacy and safety of fingolimod in patients with multiple sclerosis (MS). We present an observational study that validates these trials findings in a real-world setting, whereby the effectiveness and safety of fingolimod was assessed in Seville's' (Spain) clinical practice. This retrospective study in MS patients assessed effectiveness (relapses, EDSS, gadolinium-enhancing T1 and new/enlarged T2-weighted lesions): total cohort (n = 249) and stratified according to prior treatment (glatiramer acetate/interferon beta-1 [immunomodulator], natalizumab, naïve), gender, basal EDSS score, basal Gd+ lesions, ARR prior to treatment, age at treatment initiation and number of prior treatments. A multivariante model was used to assess the ARR with baseline characteristics. The safety profile (adverse events [AEs]) was also described. Fingolimod reduced the annualized relapse rate (ARR) by 75%, 67% and 85% in the total cohort, patients previously treated with immunomodulatory and naïve patients (p<0.0001 all cases). However, patients previously treated with natalizumab kept a constant ARR. The ARR results and the consequent increase in the proportion of relapse-free patients were independent of the age at treatment initiation, number of prior treatments, gender and basal Gd+ lesions. Although fingolimod was effective regardless the basal EDSS score and ARR prior to fingolimod treatment, better outcomes were observed in patients with basal EDSS score <3 (0.2 vs. 0.4; p = 0.0244) and ARR ≥ 2 prior to fingolimod treatment (p = 0.0338). Only the basal EDSS score was association with ARR in the first 24 months of fingolimod treatment in the multivariante model (p = 0.0439). The cumulative probability of disability progression was 20% (month-24) in the total cohort, and was independent from prior treatment, age at treatment initiation, number of prior treatments, gender

  4. The real-world effectiveness and safety of fingolimod in relapsing-remitting multiple sclerosis patients: An observational study

    PubMed Central

    Damas, Fátima; Páramo, Maria Dolores; Ruiz-Peña, Juan Luis; Navarro, Guillermo

    2017-01-01

    Fingolimod approval was based mainly on two clinical trials, FREEDOMS and TRANSFORMS, which demonstrated the efficacy and safety of fingolimod in patients with multiple sclerosis (MS). We present an observational study that validates these trials findings in a real-world setting, whereby the effectiveness and safety of fingolimod was assessed in Seville’s’ (Spain) clinical practice. This retrospective study in MS patients assessed effectiveness (relapses, EDSS, gadolinium-enhancing T1 and new/enlarged T2-weighted lesions): total cohort (n = 249) and stratified according to prior treatment (glatiramer acetate/interferon beta-1 [immunomodulator], natalizumab, naïve), gender, basal EDSS score, basal Gd+ lesions, ARR prior to treatment, age at treatment initiation and number of prior treatments. A multivariante model was used to assess the ARR with baseline characteristics. The safety profile (adverse events [AEs]) was also described. Fingolimod reduced the annualized relapse rate (ARR) by 75%, 67% and 85% in the total cohort, patients previously treated with immunomodulatory and naïve patients (p<0.0001 all cases). However, patients previously treated with natalizumab kept a constant ARR. The ARR results and the consequent increase in the proportion of relapse-free patients were independent of the age at treatment initiation, number of prior treatments, gender and basal Gd+ lesions. Although fingolimod was effective regardless the basal EDSS score and ARR prior to fingolimod treatment, better outcomes were observed in patients with basal EDSS score <3 (0.2 vs. 0.4; p = 0.0244) and ARR ≥ 2 prior to fingolimod treatment (p = 0.0338). Only the basal EDSS score was association with ARR in the first 24 months of fingolimod treatment in the multivariante model (p = 0.0439). The cumulative probability of disability progression was 20% (month-24) in the total cohort, and was independent from prior treatment, age at treatment initiation, number of prior treatments

  5. Safety and effectiveness of bevacizumab treatment for metastatic colorectal cancer: final results from the Avastin(®) Registry - Investigation of Effectiveness and Safety (ARIES) observational cohort study.

    PubMed

    Hurwitz, H I; Bekaii-Saab, T S; Bendell, J C; Cohn, A L; Kozloff, M; Roach, N; Mun, Y; Fish, S; Flick, E D; Grothey, A

    2014-06-01

    The Avastin(®) Registry - Investigation of Effectiveness and Safety (ARIES) observational cohort study (OCS) was designed to prospectively examine outcomes associated with bevacizumab-containing treatment for metastatic colorectal cancer (mCRC) in a community-based setting, where patient populations are less restricted than those in randomised trials. Patients with mCRC who were eligible for bevacizumab in combination with chemotherapy in first- or second-line treatment were enrolled from November 2006 to September 2008. There were no protocol-specified treatment regimens; the dose and schedule of bevacizumab and chemotherapy were at the treating physician's discretion. The objectives in the ARIES OCS included analyses of progression-free survival (PFS), overall survival, treatment patterns and safety in each of the first- and second-line treatment cohorts. ARIES enrolled 1550 patients with mCRC receiving first-line therapy with bevacizumab. The median follow-up time was 20.6 months. The median PFS in this cohort was 10.2 months (95% confidence interval 9.8-10.6) and the median overall survival was 23.2 months (95% confidence interval 21.2-24.8). In a separate cohort of 482 patients with second-line mCRC, the median follow-up time was 16.9 months, the median PFS and overall survival from the start of second-line treatment to the end of follow-up was 7.9 months (95% confidence interval 7.2-8.3) and 17.8 months (95% confidence interval 16.5-20.7), respectively. Incidences of known bevacizumab-associated adverse events in ARIES were generally consistent with those previously reported in OCSs and randomised trials. Results from the prospective ARIES OCS add further evidence to support the effectiveness and safety of bevacizumab when added to first- and second-line treatment regimens for patients with mCRC in community treatment settings. Copyright © 2014 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.

  6. 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

  7. 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

  8. A prospective, observational study of the effects of implementation strategy on compliance with a surgical safety checklist.

    PubMed

    Hannam, J A; Glass, L; Kwon, J; Windsor, J; Stapelberg, F; Callaghan, K; Merry, A F; Mitchell, S J

    2013-11-01

    The reported benefits of using the WHO Surgical Safety Checklist (SSC) are likely to depend on compliance with its correct use. Compliance with SSC administration in centres that have introduced the checklist under a research protocol may differ from centres where the SSC is introduced independently. To compare compliance with SSC administration at an original WHO pilot study centre (Hospital 1) with that at a similar neighbouring hospital (Hospital 2) that independently integrated the SSC with pre-existing practice. This was a prospective, observational study. One hundred operations were observed at each hospital. We recorded: compliance with administration of SSC domains (Sign In, Time Out and Sign Out) and individual domain items; timing of domain administration; and operating room team engagement during administration. Domain compliance at Hospital 1 and Hospital 2, respectively, was: 96% and 31% (p<0.0005) for Sign In; 99% and 48% (p<0.0005) for Time Out and 22% and 9% (p=0.008) for Sign Out. Engagement of two or more teams during Sign In and Time Out occurred more frequently at Hospital 2 than at Hospital 1. Compliance with administration of SSC domains was lower at Hospital 2 which introduced the SSC outside the context of a strict study protocol. This finding mandates caution in extrapolation of benefits identified in SSC studies to non-study hospitals. Staff engagement was better at Hospital 2 where checklist administration leadership is strategically shared among anaesthetic, surgical and nursing team members as compared with exclusive nursing leadership at Hospital 1. Australian and New Zealand Clinical Trials Registry: Ref: ACTRN12612000135819, http://www.anzctr.org.au/trial_view.aspx?ID=362007.

  9. 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.

  10. Safety and self-reported efficacy of botulinum toxin for adult spasticity in current clinical practice: a prospective observational study.

    PubMed

    Muller, François; Cugy, Emmanuelle; Ducerf, Camille; Delleci, Claire; Guehl, Dominique; Joseph, Pierre-Alain; Burbaud, Pierre; Dehail, Patrick

    2012-02-01

    To determine the safety and the self-reported efficacy of botulinum toxin injections for adult spasticity in current clinical practice. A prospective observational study. A total of 406 adult patients with focal spasticity received of 1136 series botulinum toxin injections at Bordeaux University Hospital from January 2007 to December 2009. Adverse events following botulinum toxin injections were reported. Their severity and the therapeutic efficacy of botulinum toxin injections were estimated with a four-point self-reporting scale (0 to 3). Latency and duration of adverse events and subjective improvement were also noted. The data of 640 series of injections were analyzed. Forty-six (7.2%) adverse events were reported, of which 36 (78%) were local. There were 18 (39%) cases of local muscular weakness with an average duration of 30.0 (SD 38.2) days, and an average severity score of 1.0 (SD 0.97). Among systemic adverse events, there were 8 (17%) cases of excessive fatigue without global muscular weakness and 2 (4%) cases of transitory generalized muscular weakness. The average subjective improvement score was 1.89 (SD 0.97) and was higher for upper, than for lower, limbs (P=0.007). Self-reported adverse events following botulinum toxin injections in spasticity are rare, often benign and of short duration in current clinical practice. Botulinum toxin is considered effective by patients in treating spasticity of the upper and lower limbs.

  11. Treatment effect and safety of EPs 7630-solution in acute bronchitis in childhood: report of a multicentre observational study.

    PubMed

    Haidvogl, M; Heger, M

    2007-01-01

    An open post-marketing surveillance study was conducted to examine the treatment effect and safety of EPs 7630-solution in the treatment of acute bronchitis in children. This study included a total of 742 children (aged between 0 and 12 years) with acute bronchitis (83.4%) or acute exacerbations of chronic bronchitis (14.3%), who were treated with different doses of the herbal drug for up to 14 days. Five bronchitis specific symptoms (BSS) were summed up to give an overall measure of disease severity. Non-specific disease symptoms (loss of appetite, diarrhoea, headache, vomiting, and fever) were also recorded, together with adverse events and overall ratings of efficacy and tolerability. The overall BSS score decreased during treatment from 6.0+/-3.0 points at baseline to 2.7+/-2.5 points after 7 days and to 1.4+/-2.1 points after 14 days. Remission or improvement in at least 80% of patients was recorded for all the individual component symptoms. The proportion of patients suffering from non-specific symptoms also substantially improved during treatment. For example, loss of appetite was present in 65.8% of patients at study begin, but only in 27.6% at the time point of last observation visit. In 88.3% of cases, the responsible physician rated the treatment as successful. Adverse events were minor and transitory. In conclusion, EPs 7630-solution was shown to be a safe and an effective treatment option for acute bronchitis or acute exacerbations of chronic bronchitis in children.

  12. Safety of a killed oral cholera vaccine (Shanchol) in pregnant women in Malawi: an observational cohort study.

    PubMed

    Ali, Mohammad; Nelson, Allyson; Luquero, Francisco J; Azman, Andrew S; Debes, Amanda K; M'bang'ombe, Maurice Mwesawina; Seyama, Linly; Kachale, Evans; Zuze, Kingsley; Malichi, Desire; Zulu, Fatima; Msyamboza, Kelias Phiri; Kabuluzi, Storn; Sack, David A

    2017-05-01

    Pregnancy increases the risk of harmful effects from cholera for both mothers and their fetuses. A killed oral cholera vaccine, Shanchol (Shantha Biotechnics, Hydrabad, India), can protect against the disease for up to 5 years. However, cholera vaccination campaigns have often excluded pregnant women because of insufficient safety data for use during pregnancy. We did an observational cohort study to assess the safety of Shanchol during pregnancy. This observational cohort study was done in two adjacent districts (Nsanje and Chikwawa) in Malawi. Individuals older than 1 year in Nsanje were offered oral cholera vaccine during a mass vaccination campaign between March 30 and April 30, 2015, but no vaccines were administered in Chikwawa. We enrolled women who were exposed to oral cholera vaccine during pregnancy in Nsanje district, and women who were pregnant in Chikwawa district (and thus not exposed to oral cholera vaccine) during the same period. The primary endpoint of our analysis was pregnancy loss (spontaneous miscarriage or stillbirth), and the secondary endpoints were neonatal deaths and malformations. We evaluated these endpoints using log-binomial regression, adjusting for the imbalanced baseline characteristics between the groups. This study is registered with ClinicalTrials.gov, number NCT02499172. We recruited 900 women exposed to oral cholera vaccine and 899 women not exposed to the vaccine between June 16 and Oct 10, 2015, and analysed 835 in each group. 361 women exposed to the vaccine and 327 not exposed to the vaccine were recruited after their pregnancies had ended. The incidence of pregnancy loss was 27·54 (95% CI 18·41-41·23) per 1000 pregnancies among those exposed to the vaccine and 21·56 (13·65-34·04) per 1000 among those not exposed. The adjusted relative risk for pregnancy loss among those exposed to oral cholera vaccine was 1·24 (95% CI 0·64-2·43; p=0·52) compared with those not exposed to the vaccine. The neonatal mortality rate

  13. Efficacy and safety of thrice weekly DOTS in tuberculosis patients with and without HIV co-infection: an observational study

    PubMed Central

    2013-01-01

    Background Despite the latest World Health Organization guidelines advocating daily therapy in HIV-TB co-infected individuals, there are few recent studies comparing outcomes of thrice-weekly anti-tuberculosis treatment in HIV-positive and HIV-negative patients with TB. The present study sets out to compare TB treatment outcomes in these two groups in the Indian national programme, which currently involves thrice-weekly therapy for all, regardless of HIV status. Methods HIV-positive and HIV-negative were consecutively screened for enrolment into this prospective observational study, carried out at the All India Institute of Medical Sciences hospital, New Delhi, India, between 2006 and 2010. Patients were given short-course thrice-weekly rifampicin-based therapy, with all HIV-positive patients being started on highly active antiretroviral therapy at least 14 days after commencing TB treatment. Patients were regularly followed-up for 24 months after completion of treatment. Results 150 HIV-positive, 155 HIV-negative patients were enrolled consecutively for the study. Significantly higher treatment success (93.5% vs. 76.7% at end of treatment, p < 0.001) and lower mortality (2.8% vs. 21.6% on follow up, p < 0.001) were observed in HIV-negative patients. No significant difference was found in treatment failure (p = 0.16), sputum smear (p = 0.58) and culture conversion (p = 0.55), and non-serious adverse event incidence (p = 0.851) between the two groups. Low baseline CD4 cell count (<100 cells/ mm3) was the only predictor of mortality in HIV-TB patients (odds ratio 8 · 43, p = 0 · 013). Conclusions Thrice-weekly anti-tuberculosis therapy is more effective in HIV-negative than in HIV-positive patients. However, outcomes in this HIV co-infected cohort were found to be similar to those reported previously with daily therapy, with no safety concerns. This should prompt further study into whether intermittent or daily therapy should be

  14. Observation of time-dependent adverse events and the influence of drop-out thereon in long-term safety studies--simulation study under the current practice of post-marketing safety evaluation in Japan.

    PubMed

    Narukawa, Mamoru; Yafune, Akifumi; Takeuchi, Masahiro

    2004-05-01

    Safety assessment of a new drug should be continuously carried out in the premarketing phase as well as in the postmarketing phase. Considering the actual conditions and problems of postmarketing safety studies in Japan, i.e., the lack of attention to the extent of patients' exposure to the drug (duration and the number of patients), we simulated the number of adverse events to be observed after specified intervals of exposure. This was done by applying different sets of hazard functions for a Weibull distribution under the circumstances that a certain number of patients has dropped out, focusing on rare and delayed adverse events associated with chronically used drugs. By using the result of these simulations, we point out potential problems of underestimating adverse event rates in situations where the hazard rate of the event escalates over time. Patients drop-out from the study also deteriorates the ability to observe such time-dependent adverse events. The simulation can also serve as a useful tool to examine the necessary sample size and the duration of exposure in order to observe and characterize potentially expected adverse events. It is important to take the two key factors into consideration: the change of hazard function over time and the effect of drop-out in designing, analyzing, and evaluating safety studies for new drugs.

  15. Safety and tolerability of ramipril 10 mg in patients at high risk of cardiovascular events: an observational study.

    PubMed

    Hathial, Manish

    2008-07-01

    To assess the safety and tolerability of ramipril 10 mg in patients at high risk of cardiovascular (CV) events by observing the levels of blood pressure (BP) and by recording the incidence of cough in these patients, a study was conducted in a total of 1048 patients who participated in the registry. Eligible patients in this prospective, observational, longitudinal, multicentre registry included all normotensives--including treated hypertensives--with BP <140/90 mm Hg, a history of coronary aritery disease and a history of cerebrovascular disease, peripheral arterial disease or diabetes (with micro-albuminuria) or dyslipidaemia, in whom ramipril was indicated for CV risk reduction and had been prescribed by the treating physician. The primary outcome was the effect on BP at 8 weeks, and the secondary outcome was the incidence of cough at 8 weeks. Ramipril was initiated at 2.5 mg once daily (OD) for a week, followed by 5 mg OD for 3 weeks and was then increased to 10 mg OD. Data was analysed using ANOVA and Chi-square test. A total of 1,048 patients participated in this registry; 868 (82.82%) continued with the treatment till the end of the registry (ie, 8 weeks). At baseline, systolic BP was 130.10 +/- 5.38 mm Hg, while diastolic BP was 81.07 +/- 4.36 mm Hg. At 8 weeks, these values changed non-significantly to 123.41 +/- 6.33 mm Hg and 79.03 +/- 4.84 mm Hg, respectively. At week 1, 41 patients had cough, which increased non-significantly to 58 by week 8. Only 6 patients complained of severe cough at week 8, which did not lead to treatment discontinuation. Tolerability of the treatment was assessed to be 'excellent' or 'good' by 63.3% patients and 67% physicians. Treatment with ramipril 10 mg daily in patients with high risk of CV events and normal/ controlled BP produced neither a significant fall in BP nor significant adverse events in real-world clinical practice and was well tolerated.

  16. Observed Food Safety Practices in the Summer Food Service Program

    ERIC Educational Resources Information Center

    Patten, Emily Vaterlaus; Alcorn, Michelle; Watkins, Tracee; Cole, Kerri; Paez, Paola

    2017-01-01

    Purpose/Objectives: The purpose of this exploratory, observational study was three-fold: 1) Determine current food safety practices at Summer Food Service Program (SFSP) sites; 2) Identify types of food served at the sites and collect associated temperatures; and 3) Establish recommendations for food safety training in the SFSP.…

  17. 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.

  18. Safety and immunogenicity of yellow fever 17D vaccine in adults receiving systemic corticosteroid therapy: an observational cohort study.

    PubMed

    Kernéis, Solen; Launay, Odile; Ancelle, Thierry; Iordache, Laura; Naneix-Laroche, Véronique; Méchaï, Frédéric; Fehr, Thierry; Leroy, Jean-Philippe; Issartel, Bertrand; Dunand, Jean; van der Vliet, Diane; Wyplosz, Benjamin; Consigny, Paul-Henri; Hanslik, Thomas

    2013-09-01

    To assess the safety and immunogenicity of live attenuated yellow fever (YF) 17D vaccine in adults receiving systemic corticosteroid therapy. All adult travelers on systemic corticosteroid therapy who had received the YF17D vaccine in 24 French vaccination centers were prospectively enrolled and matched with healthy controls (1:2) on age and history of YF17D immunization. Safety was assessed in a self-administered standardized questionnaire within 10 days after immunization. YF-specific neutralizing antibody titers were measured 6 months after vaccination in patients receiving corticosteroids. Between July 2008 and February 2011, 102 vaccine recipients completed the safety study (34 receiving corticosteroids and 68 controls). The median age was 54.9 years (interquartile range [IQR] 45.1-60.3 years) and 45 participants had a history of previous YF17D immunization. The median time receiving corticosteroid therapy was 10 months (IQR 1-67 months) and the prednisone or equivalent dosage was 7 mg/day (IQR 5-20). Main indications were autoimmune diseases (n = 14), rheumatoid arthritis (n = 9), and upper respiratory tract infections (n = 8). No serious adverse event was reported; however, patients receiving corticosteroids reported more frequent moderate/severe local reactions than controls (12% and 2%, respectively; relative risk 8.0, 95% confidence interval 1.4-45.9). All subjects receiving corticosteroids who were tested (n = 20) had neutralizing antibody titers >10 after vaccination. After YF17D immunization, moderate/severe local reactions may be more frequent in patients receiving systemic corticosteroid therapy. Immunogenicity seems satisfactory. Large-scale studies are needed to confirm these results. Copyright © 2013 by the American College of Rheumatology.

  19. 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

  20. A Phase One Safety Study of Lactobacillus reuteri Conducted in the Peruvian Amazon: Observations from the Field

    PubMed Central

    Oberhelman, Richard A.; Kosek, Margaret N.; Peñataro-Yori, Pablo; Paredes-Olórtegui, Maribel; Connolly, Eamonn

    2014-01-01

    Clinical research on probiotics presents challenging issues for researchers, regulators, and funding agencies, and these issues become more complex when United States federally funded research is conducted outside the United States. Here, we describe the design and results of a Phase I safety study of Lactobacillus reuteri DSM 17938 conducted as a community-based trial under the Food and Drug Administration Investigative New Drug (FDA IND) program in a small town in the Peruvian Amazon. Forty-five healthy adults 18 to 65 years of age were randomized in a 2:1 ratio to receive either Lactobacillus reuteri 108 organisms once daily for 5 days or an identical appearing placebo. Results showed no evidence of invasive infection resulting from probiotic administration and no differences between groups. Although we encountered several challenges in conducting an FDA-approved safety trial in this setting, the rigorously collected contextually relevant data will be very valuable to support later Phase II/III studies of L. reuteri for use in similar settings. PMID:24515943

  1. Safety and efficacy of fimasartan in patients with arterial hypertension (Safe-KanArb study): an open-label observational study.

    PubMed

    Park, Jeong Bae; Sung, Ki-Chul; Kang, Seok-Min; Cho, Eun Joo

    2013-02-01

    Angiotensin II receptor blockers (ARBs) play a key role in hypertension therapy. Recently, fimasartan, the ninth ARB, was developed, but its safety and efficacy have not been well established. The objective of this study was to determine whether age, sex, concomitant disease, and current antihypertensive medications affect the safety and efficacy of fimasartan in patients with arterial hypertension. This was a large-scale, open-label observational study to determine the safety and efficacy of fimasartan in patients with hypertension. Patients who were treated for more than 2 months with fimasartan (60 or 120 mg, once daily) were recruited, and the data were systematically collected using electronic case report forms. Written informed consent forms were obtained from all patients. A total of 14,151 patients (50.7 % males; mean age 59 ± 12 years) were evaluated, of whom 37.9 % were never treated with fimasartan, 53.5 % were switched to fimasartan, and 8.5 % had fimasartan added to their treatment. Overall, fimasartan reduced systolic blood pressure (SBP) from 145.4 ± 18.1 to 126.8 ± 12.6 mmHg and diastolic blood pressure (DBP) from 88.7 ± 11.8 to 79.0 ± 8.7 mmHg (all p < 0.001). The pulse rate decreased from 74.4 ± 10.3 to 71.9 ± 9.2 beats/min in comparison with before treatment (p < 0.001). The reductions were similar between sexes, age groups, and patients with and without co-morbidities, and were not dependent on prior or concomitant treatment with other antihypertensive drugs. Adverse events were reported in 3.31 % (treatment-emergent) and 2.35 % (drug-related) of patients; there were no dose differences for adverse events. The most frequent adverse events were dizziness (1.55 %) and headache (0.52 %); other adverse events were rare. The responder rate (DBP to <90 mmHg or a reduction of ≥10 mmHg) and the goal rate (combined SBP/DBP <140/90 mmHg) were 85.0 and 75.6 %, respectively. Global drug compliance was rated as excellent, very good, good, and poor

  2. Safety and tolerability of ramipril 10 mg in patients at high risk of cardiovascular events: an observational study.

    PubMed

    Hathial, Manish

    2008-01-01

    To assess the safety and tolerability of ramipril 10 mg in patients at high risk of cardiovascular (CV) events by observing the levels of blood pressure (BP) and by recording the incidence of cough in these patients. Eligible patients in this prospective, observational, longitudinal, multicentre registry included all normotensives-including treated hypertensives-with BP <140/90 mm Hg, a history of coronary artery disease and a history of cerebrovascular disease, peripheral arterial disease or diabetes (with microalbuminuria), or dyslipidaemia, in whom ramipril was indicated for CV risk reduction and had been prescribed by the treating physician. The primary outcome was the effect on BP at 8 weeks, and the secondary outcome was the incidence of cough at 8 weeks. Ramipril was initiated at 2.5 mg once daily (o.d.) for a week, followed by 5 mg o.d. for 3 weeks and was then increased to 10 mg o.d. Data were analyzed using ANOVA and Chi square test. A total of 1,048 patients participated in this registry; 868 (82.87 percent;) continued with the treatment till the end of the registry (i.e., 8 weeks). At baseline, systolic BP was 130.1 +/- 5.38 mm Hg, while diastolic BP was 81.07 +/- 4.36 mm Hg. At 8 weeks, these values changed non-significantly to 123.41 +/- 6.33 mm Hg and 79.03 +/- 4.84 mm Hg, respectively. At week 1, 7.1% of patients had cough, which increased non-significantly to 10% by week 8. Only 6 patients complained of severe cough at week 8, which did not lead to treatment discontinuation. Tolerability of the treatment was assessed to be "excellent" or "good" by 63.3% patients and 67% physicians. Treatment with ramipril 10 mg daily in patients with high risk of CV events and normal/controlled BP produced neither a significant fall in BP nor significant adverse events in real-world clinical practice and was well tolerated.

  3. Safety of Atrovent(®) CFC-free inhaler: respiratory events reported from an observational cohort study in England.

    PubMed

    Osborne, Vicki; Layton, Deborah; Fogg, Carole; Tong, Edward; Shakir, Saad A W

    2017-10-09

    The aim of the study was to identify any unexpected clinical events associated with starting the new CFC-free formulation of Atrovent(®) MDI in general practice in England. An active surveillance cohort study was conducted with a focus on selected clinical events, including respiratory symptoms, in past users of Atrovent(®) CFC MDI ('switchers') and Atrovent(®) naïve users. Incidence density rate ratios (with 99% confidence intervals) for events occurring in the first 3 months of exposure (risk period-ID1-3 ) compared to 3 months prior to starting treatment (reference period-IDR ) were calculated. The cohort consisted of 13 211 patients (median age 70 years, 50.1% female; 63.5% prior users of Atrovent(®) CFC MDI ('switchers')). Common respiratory events occurred at higher rates after starting treatment than before for switchers, for example lower respiratory tract infection (LRTI) [ID1 /IDR = 1.45 (99% CI: 1.17, 1.81)] and worsening asthma [ID1 /IDR = 1.58 (99% CI: 1.00, 2.51)]. Of these events only LRTI was significant for Atrovent(®) naïve patients [ID1 /IDR = 1.42 (99% CI: 1.04, 1.95)]. The results of this study suggest effect modification of risk as a result of prior Atrovent(®) CFC MDI use. Overall, Atrovent(®) CFC-free MDI appeared to be reasonably well tolerated in the immediate postmarketing period and the safety profile appeared similar to that of the CFC formulation. © 2017 Royal Pharmaceutical Society.

  4. Examining the safety of menstrual cups among rural primary school girls in western Kenya: observational studies nested in a randomised controlled feasibility study

    PubMed Central

    Juma, Jane; Nyothach, Elizabeth; Laserson, Kayla F; Oduor, Clifford; Arita, Lilian; Ouma, Caroline; Oruko, Kelvin; Omoto, Jackton; Mason, Linda; Alexander, Kelly T; Fields, Barry; Onyango, Clayton; Phillips-Howard, Penelope A

    2017-01-01

    Objective Examine the safety of menstrual cups against sanitary pads and usual practice in Kenyan schoolgirls. Design Observational studies nested in a cluster randomised controlled feasibility study. Setting 30 primary schools in a health and demographic surveillance system in rural western Kenya. Participants Menstruating primary schoolgirls aged 14–16 years participating in a menstrual feasibility study. Interventions Insertable menstrual cup, monthly sanitary pads or ‘usual practice’ (controls). Outcome measures Staphylococcus aureus vaginal colonization, Escherichia coli growth on sampled used cups, toxic shock syndrome or other adverse health outcomes. Results Among 604 eligible girls tested, no adverse event or TSS was detected over a median 10.9 months follow-up. S. aureusprevalence was 10.8%, with no significant difference over intervention time or between groups. Of 65 S.aureus positives at first test, 49 girls were retested and 10 (20.4%) remained positive. Of these, two (20%) sample isolates tested positive for toxic shock syndrome toxin-1; both girls were provided pads and were clinically healthy. Seven per cent of cups required replacements for loss, damage, dropping in a latrine or a poor fit. Of 30 used cups processed for E. coli growth, 13 (37.1%, 95% CI 21.1% to 53.1%) had growth. E. coli growth was greatest in newer compared with established users (53%vs22.2%, p=0.12). Conclusions Among this feasibility sample, no evidence emerged to indicate menstrual cups are hazardous or cause health harms among rural Kenyan schoolgirls, but large-scale trials and post-marketing surveillance should continue to evaluate cup safety. PMID:28473520

  5. Examining the safety of menstrual cups among rural primary school girls in western Kenya: observational studies nested in a randomised controlled feasibility study.

    PubMed

    Juma, Jane; Nyothach, Elizabeth; Laserson, Kayla F; Oduor, Clifford; Arita, Lilian; Ouma, Caroline; Oruko, Kelvin; Omoto, Jackton; Mason, Linda; Alexander, Kelly T; Fields, Barry; Onyango, Clayton; Phillips-Howard, Penelope A

    2017-05-04

    Examine the safety of menstrual cups against sanitary pads and usual practice in Kenyan schoolgirls. Observational studies nested in a cluster randomised controlled feasibility study. 30 primary schools in a health and demographic surveillance system in rural western Kenya. Menstruating primary schoolgirls aged 14-16 years participating in a menstrual feasibility study. Insertable menstrual cup, monthly sanitary pads or 'usual practice' (controls). Staphylococcus aureus vaginal colonization, Escherichia coli growth on sampled used cups, toxic shock syndrome or other adverse health outcomes. Among 604 eligible girls tested, no adverse event or TSS was detected over a median 10.9 months follow-up. S. aureusprevalence was 10.8%, with no significant difference over intervention time or between groups. Of 65 S.aureus positives at first test, 49 girls were retested and 10 (20.4%) remained positive. Of these, two (20%) sample isolates tested positive for toxic shock syndrome toxin-1; both girls were provided pads and were clinically healthy. Seven per cent of cups required replacements for loss, damage, dropping in a latrine or a poor fit. Of 30 used cups processed for E. coli growth, 13 (37.1%, 95% CI 21.1% to 53.1%) had growth. E. coli growth was greatest in newer compared with established users (53%vs22.2%, p=0.12). Among this feasibility sample, no evidence emerged to indicate menstrual cups are hazardous or cause health harms among rural Kenyan schoolgirls, but large-scale trials and post-marketing surveillance should continue to evaluate cup safety. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  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. Mars Observer: Phase 0 safety review data package

    NASA Technical Reports Server (NTRS)

    1986-01-01

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

  9. Survival and safety associated with aggressive surgery for stage III/IV epithelial ovarian cancer: A single institution observation study.

    PubMed

    Tate, Shinichi; Kato, Kazuyoshi; Nishikimi, Kyoko; Matsuoka, Ayumu; Shozu, Makio

    2017-10-01

    We evaluated the efficacy and safety of aggressive surgery for advanced ovarian cancer at a non-high-volume center. We evaluated consecutive patients with stage III/IV ovarian, fallopian, and peritoneal cancer undergoing elective aggressive surgery from January 2008 to December 2012, which encompassed the first 5years after implementing an aggressive surgery protocol. After receiving appropriate training for 9months, a gynecological surgical team began performing multi-visceral resections. Primary debulking surgery was chosen when the team considered that optimal surgery was achievable on the initial laparotomy, otherwise interval debulking surgery was chosen (the protocol treatments). Analysis was performed on an intention-to-treat basis (full-set analysis), and outcomes were compared to those of patients who underwent standard surgery between 2000 and 2007. Of 106 consecutive patients studied, 87 (82%) underwent aggressive surgery per protocol and 19 were excluded. Serous carcinoma was the most common disease (78%), followed by clear cell carcinoma (7%), and 32% of the patients had stage IV disease. The respective median progression-free and overall survival rates increased from 14.6 and 38.1months before implementation, respectively, to 25.0 and 68.5months after implementation, respectively. Complete resection was achieved in 83 of the 106 patients (78%), and the surgical complexity score was high (>8) in 61 patients (58%); although there was no mortality within 12weeks of surgery, major complications occurred in 8 patients. We confirmed that outcomes improved after implementing aggressive surgery for advanced ovarian cancer, without causing a significant increase in mortality. Factors enhancing survival outcomes are discussed. Copyright © 2017 Elsevier Inc. All rights reserved.

  10. Study of the Safety of Extracorporeal Cardiac Shock Wave Therapy: Observation of the Ultrastructures in Myocardial Cells by Transmission Electron Microscopy.

    PubMed

    Liu, Bing; Zhang, Yunhe; Jia, Na; Lan, Ming; Du, Ling; Zhao, Dachun; He, Qing

    2017-01-01

    Extracorporeal cardiac shock wave therapy (CSWT) has been used to treat patients with severe coronary heart disease and cardiac failure with good results; however, the safety of this treatment is still controversial. Its safety in clinical setting and on microstructures has been confirmed, but the influence of shock wave on the ultrastructures of myocardial cells is not clear. In this study, 12 Sprague-Dawley rats were randomly divided into control (NC) and CSWT therapy (NC+SW) groups. The heart rate, blood pressure, serum troponin I (TNI), and cardiac ultrasound were evaluated, and the myocardial inflammatory responses and fibrosis changes were compared. The samples were observed by transmission electron microscopy to evaluate the changes in myocardial tissue ultrastructure. The CSWT had no significant influence on rat hemodynamics indices and serum TNI, did not affect left ventricular function, and did not cause myocardial inflammatory response and fibrosis changes. The scores of myocardial ultrastructure damage in the NC and NC+SW groups were 1.39 ± 0.982 and 2.42 ± 1.009, respectively ( P = .103). The CSWT did not cause significant additional damage to myocardial ultrastructures. The safety of CWST has been preliminarily proved at the clinical, microstructure, and ultrastructure levels, but its long-term safety needs further exploration.

  11. Efficacy and safety of valsartan/amlodipine single-pill combination in 11,422 Chinese patients with hypertension: an observational study.

    PubMed

    Hu, Dayi; Liu, Lisheng; Li, Weimin

    2014-07-01

    Single-pill combination (SPC) therapy of two drugs is recommended by international guidelines, including the Chinese guidelines (2010), for the treatment of hypertension in high-risk patients who require marked blood pressure (BP) reductions. Real-world data on the efficacy and safety of valsartan/amlodipine (Val/Aml) SPC are scarce. The present study is the first observational study in China to evaluate the efficacy (primary endpoint) and safety of Val/Aml (80/5 mg) SPC in Chinese patients with hypertension whose BP was not adequately controlled by monotherapy in a real-world setting. This prospective, multicenter, open-label, post-marketing observational study included 11,422 Chinese adults (≥18 years) with essential hypertension from 238 sites of 29 provinces who were prescribed once-daily Val/Aml (80/5 mg) SPC. Patients were treated for 8 weeks. The primary efficacy variable of the study included changes in mean sitting systolic BP (MSSBP) and mean diastolic BP (MSDBP) from baseline to week 8 (end point). The secondary efficacy variable of the study included BP control rate and response rate at week 4 and 8. Safety assessments included recording and measurement of all adverse events (AEs) and vital signs in the safety population. A significant reduction of 27.1 mmHg in MSSBP (159.6 vs. 132.5 mmHg; P < 0.0001) and 15.2 mmHg in MSDBP (95.6 vs. 80.4 mmHg; P < 0.0001) from baseline was observed at week 8. The BP-lowering efficacy of Val/Aml SPC was independent of age and comorbidities. BP control of <140/90 mmHg was achieved in 76.8% (n = 8,692) of the patients. The most frequently reported AEs were dizziness (0.2%), headache (0.2%), upper respiratory tract infection (0.2%), and edema (0.2%). Only three serious AEs were reported and they were not drug-related. This is the first evidence-based real-world data in Chinese hypertensive patients which demonstrate the efficacy and safety of Val/Aml (80/5 mg) SPC.

  12. 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.

  13. Long-term safety and efficacy of deferasirox in young pediatric patients with transfusional hemosiderosis: Results from a 5-year observational study (ENTRUST).

    PubMed

    Vichinsky, Elliott; El-Beshlawy, Amal; Al Zoebie, Azzam; Kamdem, Annie; Koussa, Suzanne; Chotsampancharoen, Thirachit; Bruederle, Andreas; Gilotti, Geralyn; Han, Jackie; Elalfy, Mohsen

    2017-09-01

    Children with red blood cell disorders may receive regular transfusions from an early age and consequently accumulate iron. Adequate iron chelation therapy can prevent organ damage and delayed growth/development. Deferasirox is indicated for treatment of pediatric patients with chronic iron overload due to transfusional hemosiderosis; however, fewer than 10% of patients in the registration studies were aged 2 to less than 6 years. Deferasirox, a once-daily oral iron chelator, was evaluated in young pediatric patients with transfusional hemosiderosis during the observational 5-year ENTRUST study. Patients aged 2 to less than 6 years at enrollment received deferasirox according to local prescribing information, with the primary objective of evaluating safety, specifically renal and hepatic function. Serum ferritin was observed as a surrogate efficacy parameter. In total, 267 patients (mean age 3.2 years) predominantly with β-thalassemia (n = 176, 65.9%) were enrolled. Mean ± standard deviation deferasirox dose was 25.8 ± 6.5 mg/kg per day over a median of 59.9 months. A total of 145 patients (54.3%) completed 5 years' treatment. The proportion of patients with two or more consecutive postbaseline measurements (≥7 days apart) of serum creatinine higher than age-adjusted upper limit of normal (ULN) and alanine aminotransferase more than five times the ULN was 4.4% (95% confidence interval [CI]: 2.1-7.9) and 4.0% (95% CI: 1.8-7.4), respectively. Median serum ferritin decreased from 1,702 ng/ml at baseline to 1,127 ng/ml at 5 years. There were no new safety signals. Safety and efficacy of deferasirox in young pediatric patients in this long-term, observational study in everyday clinical practice were consistent with the known deferasirox profile. © 2017 The Authors. Pediatric Blood & Cancer Published by Wiley Periodicals, Inc.

  14. 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.

  15. Safety Profile of Anticancer and Immune-Modulating Biotech Drugs Used in a Real World Setting in Campania Region (Italy): BIO-Cam Observational Study.

    PubMed

    Scavone, Cristina; Sportiello, Liberata; Sullo, Maria G; Ferrajolo, Carmen; Ruggiero, Rosanna; Sessa, Maurizio; Berrino, Pasquale M; di Mauro, Gabriella; Berrino, Liberato; Rossi, Francesco; Rafaniello, Concetta; Capuano, Annalisa

    2017-01-01

    Objectives: To investigate the occurrence of adverse events (AEs) in naïve patients receiving biotech drugs. Design: A prospective observational study. Setting: Onco-hematology, Hepato-gastroenterology, Rheumatology, Dermatology, and Neurology Units in Campania Region (Italy). Participants: 775 patients (53.81% female) with mean age 56.0 (SD 15.2). The mean follow-up/patient was 3.48 (95% confidence interval 3.13-3.84). Main outcome measures: We collected all AEs associated to biotech drugs, including serious infections and malignancies. Serious AEs were defined according to the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, clinical safety data management: definitions and standards for expedited reporting E2A guideline. Results: The majority of the study population was enrolled in Onco-hematology and Rheumatology Units and the most common diagnosis were hematological malignancies, followed by rheumatoid arthritis, colorectal cancer, breast cancer, and psoriatic arthritis. The most commonly prescribed biotech drugs were rituximab, bevacizumab, infliximab, trastuzumab, adalimumab, and cetuximab. Out of 775 patients, 320 experienced at least one AE. Most of patients experienced AEs to cetuximab therapy, rituximab and trastuzumab. Comparing female and male population, our findings highlighted a statistically significant difference in terms of AEs for adalimumab (35.90% vs. 7.41%, p < 0.001) and etanercept (27.59% vs. 10.00%, p = 0.023). Considering all biotech drugs, we observed a peak for all AEs occurrence at follow-up 91-180 days category. Bevacizumab, brentuximab, rituximab, trastuzumab and cetuximab were more commonly associated to serious adverse events; most of these were possibly related to biotech drugs, according to causality assessment. Three cases of serious infections occurred. Conclusions: The results of our study demonstrated that the majority of AEs were not serious and expected

  16. 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

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

    PubMed

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

    2016-12-01

    To evaluate the efficacy and safety of dienogest treatment in patients who had received dienogest for 12 months or more to treat endometriosis. 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. 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. 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.

  18. 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

  19. 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

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

    2014-01-01

    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. To assess the efficacy and safety of WIN-BP (Olmesartan 20 mg/40 mg) tablet in Indian patients with hypertension. 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. 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. Olmesartan 20 mg/40 mg is effective and well tolerated without any serious adverse events in patients with hypertension. Copyright © 2014 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

  20. 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

  1. 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

  2. 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

  3. Safety in earth orbit study

    NASA Technical Reports Server (NTRS)

    1972-01-01

    Safety aspects are studied of the space shuttle orbiter, the shuttle payloads, and space stations in earth orbital operations. The tasks generated safety requirements, guidelines, recommendations, and conceptual safety devices. The tasks studied were: hazardous payloads, docking, onboard survivability tumbling spacecraft, and escape and rescue operations.

  4. 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

  5. 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.

  6. 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.

  7. Efficacy and safety of adalimumab in Behçet's disease-related uveitis: a multicenter retrospective observational study.

    PubMed

    Fabiani, Claudia; Vitale, Antonio; Emmi, Giacomo; Vannozzi, Lorenzo; Lopalco, Giuseppe; Guerriero, Silvana; Orlando, Ida; Franceschini, Rossella; Bacherini, Daniela; Cimino, Luca; Soriano, Alessandra; Frediani, Bruno; Galeazzi, Mauro; Iannone, Florenzo; Tosi, Gian Marco; Salvarani, Carlo; Cantarini, Luca

    2017-01-01

    The study aim was to evaluate the efficacy of adalimumab (ADA) in a large series of Behçet's disease (BD)-related uveitis. We performed a multicenter retrospective observational study including 40 selected patients (66 eyes) receiving ADA. Clinical data were retrospectively analyzed at baseline, at 3 and 12 months of treatment. Primary end point was reduction of ocular inflammatory flares. Secondary end points were improvement of best corrected visual acuity (BCVA), reduction of macular thickness measured by optical coherence tomography (OCT), reduction in the occurrence of vasculitis assessed by fluorescein angiography (FA), and evaluation of statistically significant differences between patients treated with ADA monotherapy and those undergoing ADA plus DMARDs and in patients firstly treated with ADA compared to patients previously administered with other biologics; ADA steroid sparing effect was also evaluated. During the first 12 months of ADA therapy, the number of flares significantly decreased from 200 flares/100 patients/year to 8.5 flares/100 patients/year (p < 0.0001). Similarly, BCVA improved if compared to baseline (7.4 ± 2.9 versus 8.5 ± 2.1, p = 0.03). OCT findings significantly improved showing a mean reduction of central macular thickness (CMT) of 27.27 ± 42.8 μm at the end of follow-up (p < 0.006). FA identified retinal vasculitis in 22 cases at baseline (55%), 8 (20%) cases after 3 months, and in only one (2.5%) case at 12-month follow-up. FA improvement was highly significant at 3- and 12-month follow-up if compared to baseline (p < 0.0001 and p = 0.006, respectively). ADA is highly effective and safe for the treatment of BD-related uveitis, providing a long-term control of ocular inflammation.

  8. 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

  9. 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…

  10. 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

  11. Safety Outcomes and Near-Adult Height Gain of Growth Hormone-Treated Children with SHOX Deficiency: Data from an Observational Study and a Clinical Trial

    PubMed Central

    Benabbad, Imane; Rosilio, Myriam; Child, Christopher J.; Carel, Jean-Claude; Ross, Judith L.; Deal, Cheri L.; Drop, Stenvert L.S.; Zimmermann, Alan G.; Jia, Nan; Quigley, Charmian A.; Blum, Werner F.

    2017-01-01

    Background/Aims To assess auxological and safety data for growth hormone (GH)-treated children with SHOX deficiency. Methods Data were examined for GH-treated SHOX-deficient children (n = 521) from the observational Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS). For patients with near-adult height information, GeNeSIS results (n = 90) were compared with a clinical trial (n = 28) of SHOX-deficient patients. Near-adult height was expressed as standard deviation score (SDS) for chronological age, potentially increasing the observed effect of treatment. Results Most SHOX-deficient patients in GeNeSIS had diagnoses of Leri-Weill syndrome (n = 292) or non-syndromic short stature (n = 228). For GeNeSIS patients with near-adult height data, mean age at GH treatment start was 11.0 years, treatment duration 4.4 years, and height SDS gain 0.83 (95% confidence interval 0.49-1.17). Respective ages, GH treatment durations and height SDS gains for GeNeSIS patients prepubertal at baseline (n = 42) were 9.2 years, 6.0 years and 1.19 (0.76-1.62), and for the clinical trial cohort they were 9.2 years, 6.0 years and 1.25 (0.92-1.58). No new GH-related safety concerns were identified. Conclusion Patients with SHOX deficiency who had started GH treatment before puberty in routine clinical practice had a similar height gain to that of patients in the clinical trial on which approval for the indication was based, with no new safety concerns. PMID:28002818

  12. Safety Outcomes and Near-Adult Height Gain of Growth Hormone-Treated Children with SHOX Deficiency: Data from an Observational Study and a Clinical Trial.

    PubMed

    Benabbad, Imane; Rosilio, Myriam; Child, Christopher J; Carel, Jean-Claude; Ross, Judith L; Deal, Cheri L; Drop, Stenvert L S; Zimmermann, Alan G; Jia, Nan; Quigley, Charmian A; Blum, Werner F

    2017-01-01

    To assess auxological and safety data for growth hormone (GH)-treated children with SHOX deficiency. Data were examined for GH-treated SHOX-deficient children (n = 521) from the observational Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS). For patients with near-adult height information, GeNeSIS results (n = 90) were compared with a clinical trial (n = 28) of SHOX-deficient patients. Near-adult height was expressed as standard deviation score (SDS) for chronological age, potentially increasing the observed effect of treatment. Most SHOX-deficient patients in GeNeSIS had diagnoses of Leri-Weill syndrome (n = 292) or non-syndromic short stature (n = 228). For GeNeSIS patients with near-adult height data, mean age at GH treatment start was 11.0 years, treatment duration 4.4 years, and height SDS gain 0.83 (95% confidence interval 0.49-1.17). Respective ages, GH treatment durations and height SDS gains for GeNeSIS patients prepubertal at baseline (n = 42) were 9.2 years, 6.0 years and 1.19 (0.76-1.62), and for the clinical trial cohort they were 9.2 years, 6.0 years and 1.25 (0.92-1.58). No new GH-related safety concerns were identified. Patients with SHOX deficiency who had started GH treatment before puberty in routine clinical practice had a similar height gain to that of patients in the clinical trial on which approval for the indication was based, with no new safety concerns. © 2016 The Author(s) Published by S. Karger AG, Basel.

  13. Single centre observational study to evaluate the safety and efficacy of the Proceed™ Ventral Patch to repair small ventral hernias.

    PubMed

    Bontinck, J; Kyle-Leinhase, I; Pletinckx, P; Vergucht, V; Beckers, R; Muysoms, F

    2014-10-01

    There is evidence that mesh repair for primary umbilical hernias results in less recurrences and similar wound complication rates compared to tissue repair. In recent years, several mesh devices for the repair of small ventral hernias have been developed, but some reports have been published on serious complications and adverse effects encountered with those mesh devices. The Proceed™ Ventral Patch (PVP™) is a partially absorbable lightweight polypropylene mesh. We introduced PVP™ in our department in April 2009 and collected patient data and outcome in an observational study of 101 consecutive patients until December 2011 (Clinical.Trials.gov: NCT01307696). In addition to the routine control 3 weeks postoperative, prospective follow-up included a questionnaire, clinical investigation and ultrasound after 12 months. The study included 91 primary (76 umbilical/15 epigastric) and 10 incisional ventral hernias (including 6 trocar hernias). In all patients a PVP™ with a diameter of 6.4 cm was used. Wound problems were the most frequent complication (n = 18). Follow-up of at least 12 months was achieved in 98 patients (97 %) and the mean follow-up time was 15.9 months. Follow-up by clinical examination diagnosed a recurrence in 11/92 patients (12.0 %). Only four patients were aware of their recurrent hernia, the seven others reported no problems in the questionnaire. The additional ultrasound performed did not reveal recurrences that were not already diagnosed by clinical examination. In five patients a reoperation for repair of the recurrence was performed (reoperation rate 5/98 = 5.1 %). Hernia defect size (p = 0.032) and type of hernia (p = 0.029) were found to be a significant risk factors for development of a recurrent hernia (Fisher's exact test). Hernia size was a significant risk factor both in a univariate (p = 0.005) and in a multivariate Cox model (p = 0.017). Incisional hernia was of borderline significance in a univariate (p

  14. 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.

  15. [Efficacy and safety of acute bronchitis treatment in adults--a comparison of Bronchosol® syrup and synthetic preparations with ambroxol. Results of observational study].

    PubMed

    Fal, Andrzej M; Schönknecht, Karina

    2015-01-01

    Upper respiratory tract infections (URTI), including acute bronchitis, are the frequent health problems and the most common reason for acute cough in adults. Even though the infections are caused mainly by viruses, and their course is usually not complicated, febrifuges, i.a. mucokinetics, or antitussives are used in the treatment of URTI in order to improve the quality of life and safety of patients. To evaluate the efficacy and safety of Bronchosol® herbal syrup in comparison to ambroxol preparations in the treatment of acute bronchitis in adult patients. The Bronchosol®/2013 study was a non-interventional, prospective, open-label, observational study. Data from adult patients treated with Bronchosol® syrup for acute bronchitis were collected and compared with data from patients treated for the same condition with ambroxol preparations. The severity of bronchitis symptoms was evaluated with the BSS (Bronchitis Severity Score) scale, and patients'quality of life wasassessed with the VAS (Visual Analogue Scale) scale. Between visits patients conducted self-observations and filled out observation diaries. Moreover, the data on adverse events were collected. In 87.68% of patients the infections were cured. Most of patients considered the studied drugs to be the agent decreasing the duration of infection and its intensity. The percentage of patients who declared that they had a less intense cough than during earlier infections was higher in the group of patients treated with Bronchosol® syrup in comparison to ambroxol treated patients (60.22% vs. 45.03%). 91.94% of patients treated with Bronchosol® considered this syrup to be very safe; in the ambroxol group such a declaration was made by 76.61% of patients. Bronchosol® syrup is an efficient, well-tolerated, and safe drug. Its efficacy in the treatment of acute bronchitis symptoms in adult patients is similar to the efficacy of ambroxol preparations.

  16. 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

  17. Observational study of child restraining practice on Norwegian high-speed roads: restraint misuse poses a major threat to child passenger safety.

    PubMed

    Skjerven-Martinsen; Naess, P A; Hansen, T B; Staff, T; Stray-Pedersen, A

    2013-10-01

    Restraint misuse and other occupant safety errors are the major cause of fatal and, severe injuries among child passengers in motor vehicle collisions. The main objectives of the present, study were to provide estimates of restraining practice among children younger than 16 years, traveling on Norwegian high-speed roads, and to uncover the high-risk groups associated with, restraint misuse and other safety errors. A cross-sectional observational study was performed in conjunction with regular traffic, control posts on high-speed roads. The seating and restraining of child occupants younger than 16, years were observed, the interior environment of the vehicles was examined, and a structured, interview of the driver was conducted according to a specific protocol. In total, 1260 child occupants aged 0-15 years were included in the study. Misuse of restraints, was observed in 38% of cases, with this being severe or critical in 24%. The presence of restraint, misuse varied significantly with age (p<0.001), with the frequency being highest among child, occupants in the age group 4-7 years. The most common error in this group was improperly routed, seat belts. The highest frequency of severe and critical errors was observed among child occupants in, the age group 0-3 years. The most common errors were loose or improperly routed harness straps and, incorrect installations of the child restraint system. Moreover, 24% of the children were seated in, vehicles with heavy, unsecured objects in the passenger compartment and/or the trunk that were, likely to move into the compartment upon impact and cause injury. No totally unrestrained children, were observed. This study provides a detailed description of the characteristics of restraint misuse and, the occupant's exposure to unsecured objects. Future education and awareness campaigns should, focus on children aged <8 years. The main challenges are to ensure correct routing and tightness of, harness straps and seat belts

  18. Efficacy and safety of eslicarbazepine acetate monotherapy for partial-onset seizures: Experience from a multicenter, observational study.

    PubMed

    Toledano, Rafael; Jovel, Camilo Espinosa; Jiménez-Huete, Adolfo; Bayarri, Pau Giner; Campos, Dulce; Gomariz, Elena López; Giráldez, Beatriz González; García-Morales, Irene; Falip, Mercé; Agredano, Paula Martínez; Palao, Susana; Prior, María José Aguilar Amat; Pascual, María Rosa Querol; Navacerrada, Francisco José; González, Francisco Javier López; Ojeda, Joaquín; Sáez, Aránzazu Alfaro; Bermejo, Pedro Emilio; Gil-Nagel, Antonio

    2017-08-01

    Eslicarbazepine acetate (ESL, Aptiom™) is a once-daily anticonvulsant, approved as adjunctive treatment of partial-onset seizures (POS). Historical-controlled trials investigating the use of ESL as monotherapy have demonstrated a favorable efficacy and tolerability profile in patients with POS. This prospective, non-interventional study recruited POS patients in 17 hospitals in Spain. After a 3-month baseline period, ESL therapy was initiated as 400mg QD and up-titrated to an optimal maintenance dose based on clinical response and tolerance. The incidence of seizures was assessed via seizure calendars and the nature and severity of adverse events (AEs) were also recorded. A total of 117 patients (aged 9-87years) enrolled in the study and were treated with ESL at either 400mg/day (3.4% patients), 800mg/day (61% patients), 1200mg/day (27.1% patients) or 1600mg/day (8.5% patients). At 3months, 82.0% (n=72) of patients achieved a ≥50% reduction in seizure frequency, compared to 79.7% (n=67) of patients at 6months and 83.0% (n=49) at 12months. Patients who suffered secondary generalized tonic-clonic (SGTC) seizures had seizure-free rates of 71% (n=27), 69.6% (n=29), and 72.7% (n=16) at 3, 6, and 12months, respectively. Overall, 18 patients (15.3%) reported AEs of instability and dizziness (n=9), somnolence (n=3), mild hyponatremia (n=3), headache (n=1), hypertriglyceridemia (n=1), and allergic reaction (n=1), which caused ESL discontinuation of ESL treatment. ESL is effective and well tolerated as monotherapy for patients with POS, which supports previous findings. Early use is supported by its frequent use as monotherapy in this study and lack of severe side effects. Copyright © 2017 Elsevier Inc. All rights reserved.

  19. 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.

  20. 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.

  1. Efficacy, effectiveness and safety of fumaric acid esters in the treatment of psoriasis: a systematic review of randomized and observational studies.

    PubMed

    Balak, D M W; Fallah Arani, S; Hajdarbegovic, E; Hagemans, C A F; Bramer, W M; Thio, H B; Neumann, H A M

    2016-08-01

    Fumaric acid esters (FAEs) are increasingly used as a systemic treatment for psoriasis, but there are still uncertainties regarding their suitability. The objective of this systematic review was to assess the evidence for the efficacy and safety of FAEs in psoriasis treatment. A systematic literature search was performed in seven databases up to 17 August 2015. Inclusion criteria were studies that reported clinical effects of FAEs in patients with psoriasis without restrictions in study design, language or publication date. Methodological quality of randomized controlled trials (RCTs) and overall level of quality were assessed using the Cochrane risk of bias tool and the Grading of Recommendation, Assessment, Development and Evaluation approach, respectively. A total of 68 articles were included. There were seven RCTs (total 449 patients) that had an unclear risk of bias and were too clinically heterogeneous to allow a meta-analysis. Overall, mean Psoriasis Area and Severity Index decreased by 42-65% following 12-16 weeks of treatment. There were 37 observational studies (a total of 3457 patients) that supported the RCT findings, but most were uncontrolled with a high risk of bias. Commonly reported adverse events included gastrointestinal complaints and flushing, leading to treatment withdrawal in 6-40% of patients. Several case-reports described rare adverse events, such as renal Fanconi syndrome and progressive multifocal leukoencephalopathy. There was a lack of studies focusing on long-term use and comparisons with other treatments. This review concluded that there is low-quality evidence to recommend the use of oral FAEs to treat plaque psoriasis in adult patients. Studies focusing on long-term safety and comparison with systemic psoriasis treatments could lead to a better understanding of the role of FAEs as a treatment for psoriasis. © 2016 British Association of Dermatologists.

  2. Safety and effectiveness of adalimumab in patients with rheumatoid arthritis over 5 years of therapy in a phase 3b and subsequent postmarketing observational study

    PubMed Central

    2014-01-01

    Introduction Patients with active rheumatoid arthritis who had failed at least one disease-modifying anti-rheumatic drug (DMARD) were treated with adalimumab (ADA) in the ReAct study with the option to continue treatment for 5 years in ReAlise. The purpose of this study was to evaluate the long-term safety and effectiveness of ADA as prescribed from the first injection in ReAct to the last observation in ReAlise. Methods Patients received ADA alone or in combination with DMARDs according to usual clinical care practices. Adverse events (AEs) were tabulated by five time windows after the first ADA injection. Effectiveness measures included achievement of low disease activity (LDA), defined as Simplified Disease Activity Index (SDAI) ≤11, or remission, (REM), defined as SDAI ≤3.3. Results Of the 6,610 ReAct patients, 3,435 (52%) continued in ReAlise. At baseline in ReAct, mean age was 54 years, mean DAS28 was 6.0 and mean HAQ DI was 1.64. The mean treatment duration was 1,016 days, representing 18,272 patient-years (PYs) of ADA exposure. Overall incidence rates of serious AEs and serious infections were 13.8 and 2.8 events (E)/100 PYs, respectively. Serious AEs occurred most frequently in the first 6 months and deceased thereafter. Standardised mortality ratio was 0.71 (95% CI 0.57 to 0.87) and standardised incidence ratio for malignancies was 0.64 (95% CI 0.53 to 0.76). LDA was achieved by 50% and REM by 21% of patients at last observation. Conclusions Results of this large observational study of ADA in routine clinical practice were consistent with controlled trials, with no new safety concerns during a follow-up of more than 5 years. Effectiveness of ADA was maintained during long-term observation. Trial registration NCT00448383, NCT00234884 PMID:24460746

  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. A prospective observational study of the clinical efficacy and safety of intra-articular sodium hyaluronate in synovial joints with osteoarthritis.

    PubMed

    Foti, C; Cisari, C; Carda, S; Giordan, N; Rocco, A; Frizziero, A; Della Bella, G

    2011-09-01

    Clinical trials have demonstrated the safety and efficacy of hyaluronic acid-based products for the treatment of synovial joints affected by osteoarthritis (OA), but data from observational studies of normal medical practice are sparse. This study investigated the safety and efficacy of intra-articular (IA) sodium hyaluronate (MW 1500-2000 KDa; Hyalubrix®) in the treatment of synovial joint OA. This is prospective, and observational study. This study was carried out at 47 specialist centers for physiatrists, orthopedics and rheumatology in Italy; the enrolled population, 1266 outpatient, was predominantly female (66%, 840/1266), with a mean age of 66 years, and a mean weight of 74 kg. The Participants with OA received IA injections of the study treatment (2 mL) once per week for 3 weeks. The knee was the joint most commonly affected by OA (right knee 802/1266 [63%]; left knee 598/1266 [47%]), and the longest median duration of disease occurred in the carpal joint (right carpal joint 40 months; left carpal joint 60 months). The primary endpoints were tolerability and details of usage of the IA sodium hyaluronate syringe device. Efficacy parameters included assessment of self-reported pain via the Visual Analogue Scale (VAS), and evaluation of motor function via the Health Assessment Questionnaire (HAQ). Quality of life (QoL) was assessed using the Euro QoL questionnaire (Clinical Trial Registration Number: ISRCTN 42690497). Data from 1266 participants were collected. The adverse event (AE) rate was 0.8% (95% CI, 0.4 to 1.5). Thirteen AEs were reported, 12 of which were mild or moderate in severity. Only one participant discontinued study treatment following an AE. No serious adverse events occurred. Coadministration of local anesthetic was required by up to 10% of patients. Statistically significant improvements in VAS, HAQ and EuroQoL were recorded in multiple joints (P<0.0001 for each). The study treatment was safe and well tolerated. . The study treatment

  5. 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

  6. Post-authorization safety study of Clottafact(®) , a triply secured fibrinogen concentrate in congenital afibrinogenemia. A prospective observational study.

    PubMed

    Négrier, C; Rothschild, C; Borg, J-Y; Lambert, T; Claeyssens, S; Sanhes, L; Stieltjes, N; Bertrand, A; André, M-H; Sié, P; Gruel, Y; Tellier, Z

    2016-11-01

    A new fibrinogen concentrate Clottafact(®) was developed according to European guidelines on plasma-derived products. A post-authorization safety study was set up in 2009 as part of the risk management plan. This was a non-interventional, prospective, non-comparative, multicenter study of the use of fibrinogen concentrate for congenital afibrinogenemia in real-life medical practice in France. The analysis was descriptive and performed on 3 subgroups: prophylaxis vs. on-demand treatment, age (<6, <12 and ≥12) and severity of the deficiency. Fourteen patients [1-78 years] were included in 7 centres and followed for 1 year. Twenty-one adverse drug reactions (ADRs) classically reported with fibrinogen (pallor, chills, cough, vomiting, headache, urticaria and erythematous rash) were reported in 5 of 14 patients. Two ADRs were serious: an anaphylactic shock and a subclavian venous thrombosis with a favourable outcome without sequelae. In the nine patients under prophylaxis, 365 of 367 infusions were considered as successful (99·5%) and 2 as failures. For the five patients treated on-demand, the efficacy was rated as excellent for 27 of 48 infusions and good for the 21 others. This study confirms that the benefit/risk balance for this fibrinogen concentrate is favourable. © 2016 International Society of Blood Transfusion.

  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. [Fingolimod: effectiveness and safety in routine clinical practice. An observational, retrospective, multi-centre study in Navarra, Gipuzkoa and La Rioja].

    PubMed

    Ayuso, T; Marzo-Sola, M E; Castillo-Trivino, T; Soriano, G; Otano, M A; Lopez, M A; Croitoru, I M; Olascoaga, J

    2016-09-05

    To evaluate the effectiveness and safety of fingolimod in clinical practice in Navarra, Gipuzkoa and La Rioja regions. We conducted a retrospective multi-centre study with recurrent multiple sclerosis patients treated with fingolimod, following the product data sheet. The following data were evaluated: annualised relapse rate (ARR), percentage of patients free from relapses, disability using the Expanded Disability Status Scale (EDSS) and the percentage of patients without gadolinium-enhancing lesions. A total of 113 patients were treated with fingolimod: 6% were naive, and 58% and 35% were patients previously treated with an immunomodulator and natalizumab, respectively. Fingolimod lowered the ARR after the first (67%; 1 to 0.3; p < 0.0001) and second (89%; 1 to 0.1; p < 0.0001) years of treatment, and thus the number of patients free from relapses during the treatment increased. The baseline EDSS was 3 and after treatment with fingolimod was 2.5 in both years. The percentage of patients without gadolinium-enhancing lesions after the first year of treatment was 77%. Similar results were observed in naive patients and in those previously treated with an immunomodulator. In patients previously treated with natalizumab no changes were observed following the treatment. The use of fingolimod in clinical practice showed an effectiveness similar to that observed in clinical trials. There were no changes in the ARR after changing from natalizumab, and only one patient presented a 'relapse' after withdrawal of natalizumab. Fingolimod acts like a safe drug, with scarce side effects and a low percentage of drop-outs.

  9. Three-day treatment with imipenem for unexplained fever during prolonged neutropaenia in haematology patients receiving fluoroquinolone and fluconazole prophylaxis: a prospective observational safety study.

    PubMed

    Slobbe, Lennert; Waal, Loes van der; Jongman, Lydia R; Lugtenburg, Pieternella J; Rijnders, Bart J A

    2009-11-01

    Guidelines advocate >7d of broad-spectrum antibiotics for unexplained fever (UF) during neutropaenia. However, effective antimicrobial prophylaxis reduces the incidence of gram-negative infections, which may allow shorter treatment. This study evaluates the safety of discontinuing empirical broad-spectrum antibiotics if no microbial source is documented after an initial work-up of 72 h. Prospective observational study at a tertiary-care haematology-unit in patients suffering from haematologic malignancies and treatment-induced prolonged neutropaenia of 10d. Oral fluoroquinolone and fluconazole prophylaxis was given from day 1. Fever was empirically treated with imipenem which was discontinued after 72 h if, following a standardised protocol, no infectious aetiology was documented. Duration of fever, antimicrobial therapy and overall mortality were registered. One hundred and sixty six patients were evaluated during 276 neutropaenic episodes. One hundred and thirty six patients (82.5%) experienced 1 febrile episode. A total of 317 febrile episodes were observed, of which 177 (56%) were diagnosed as UF. In 135 febrile episodes (43%), a probable/definite infectious origin was documented. Mean duration of fever in neutropaenic periods with 1 febrile episode was 5d, and mean time of treatment with imipenem was 4.7d. In patients without documented infection, mean time of imipenem treatment was only 3.7d. Overall mortality 30 d after neutrophil recovery was 3.6% (6/166); no patient died from untreated bacterial infection. Discontinuation of broad-spectrum antibiotics during neutropaenia in haematology patients on fluoroquinolone and fluconazole prophylaxis is safe, provided that no infectious aetiology is established after 72 h.

  10. Safety profiles of non-small cell lung cancer patients treated with pemetrexed plus carboplatin: a real-world retrospective, observational, cohort study.

    PubMed

    Chen, Lei; San Antonio, Belen; Yan, Yu; Chen, Jian; Goodloe, Robert J; John, William J

    2017-05-01

    Pemetrexed plus carboplatin (PCb) is a frequently used first-line treatment in advanced non-small cell lung cancer (NSCLC). This study examined the characteristics and safety profile of a NSCLC population treated with PCb area under the concentration-time curve 5 (PCb5) or 6 mg/mL•min (PCb6) under real-world conditions. A retrospective, observational, cohort study was conducted, utilizing data from the IMS Oncology US clinic-based, longitudinal, patient-level electronic medical records (EMR), including patients with NSCLC on PCb5 or PCb6 regimens initiated concomitantly on or after the diagnosis of lung cancer during 2004-2014. Patient characteristics and incidence of adverse events (AEs) were described for each cohort. Propensity scores were calculated based on baseline demographic and clinical factors. Propensity score stratification was used to further adjust for cohort differences. In total, 636 NSCLC patients receiving PCb5 (37% aged ≥70 years) and 184 patients receiving PCb6 (34% aged ≥70 years) who met the inclusion criteria were identified in the EMR. Patients with more comorbidities were more likely to have received PCb5. Overall incidence rates (IRs) per 100 person-years were similar for neutropenia in both cohorts, were numerically higher for anemia (IR = 43.6 vs 101.0) and thrombocytopenia (IR = 1.5 vs 17.9), and were numerically lower for nausea (IR = 14.4 vs 9.9) in the PCb6 vs PCb5 cohort. Within the PCb6 cohort, the IR per 100 person-years was higher for neutropenia for ≥70 year-old patients (IR = 41.1) compared to <70 year-old patients (IR = 14.5). After propensity score stratification, adjusted IRs showed similar patterns. Limitations included lack of power for AEs other than anemia, given the nature of EMR. Results from this real-world analysis add to existing evidence from randomized clinical trials about PCb safety profiles in the overall NSCLC population and in elderly patients. These results may guide physicians

  11. Effectiveness and safety of post-induction phase bevacizumab treatment for patients with non-small-cell lung cancer: results from the ARIES observational cohort study.

    PubMed

    Kosty, Michael P; Wozniak, Antoinette J; Jahanzeb, Mohammad; Leon, Larry; Fish, Susan; Hazard, Sebastien J; Lynch, Thomas J

    2015-12-01

    Data from randomized, controlled trials suggest that post-induction phase (IP) treatment with bevacizumab may benefit patients with advanced non-small-cell lung cancer (NSCLC). Real-world clinical practice, however, can involve variable use and patterns of treatment in broader patient populations. To assess the effect of bevacizumab on post-IP overall survival (OS) following IP chemotherapy + bevacizumab, analyses were conducted in patients enrolled in the Avastin(®) Registry--Investigation of Effectiveness and Safety (ARIES) observational cohort study (OCS) who received post-IP bevacizumab. ARIES was a large, prospective OCS of patients who received chemotherapy in combination with bevacizumab for the first-line treatment of NSCLC. This unplanned, post hoc analysis included patients who received chemotherapy and bevacizumab and who did not have progressive disease through the completion of IP treatment. A dichotomous analysis compared outcomes in patients who did and did not receive bevacizumab before a landmark date of day 30 post IP. A cumulative exposure analysis used a time-dependent Cox regression model to assess the effect of cumulative post-IP bevacizumab exposure on post-IP OS. In the dichotomous analysis, the duration of post-IP OS was significantly longer in patients who received post-IP bevacizumab; median post-IP OS was 15.6 vs. 11.3 months, respectively (hazard ratio [HR] = 0.80; 95 % confidence interval 0.71-0.91; P < 0.001). The cumulative exposure analysis observed that each additional cycle of cumulative bevacizumab exposure decreased the HR for post-IP OS by 2.7 %, on average. In conclusion, post-IP bevacizumab exposure was associated with improved post-IP OS in patients with advanced NSCLC who were enrolled in the ARIES OCS.

  12. Baseline characteristics and hospitalizations in patients with schizophrenia receiving olanzapine long-acting injection: an interim analysis from a non-interventional, prospective observational safety study.

    PubMed

    Jones, Meghan E; Andrews, Jeffrey S; Faries, Douglas E; Landry, John; Xu, Jenny; Detke, Holland C; Chhabra-Khanna, Rashna; McDonnell, David P

    2015-11-13

    Depot antipsychotics are a treatment option for medication nonadherence in patients with schizophrenia. Nonadherence can lead to increased relapse and hospitalization rates. This article reports hospitalization data before and after initiation of olanzapine long-acting injection (LAI), a depot antipsychotic. Data were assessed from an ongoing, multinational, prospective, observational post-authorisation safety study being conducted to evaluate post-injection delirium/sedation syndrome (PDSS), an adverse reaction that can occur following injection of olanzapine LAI. Eligible patients were aged ≥18 years, diagnosed with schizophrenia, were prescribed olanzapine LAI, and lived outside the United States. Psychiatric hospitalization and medication data were collected retrospectively for the 6-month period before study entry and prospectively throughout the study. Paired t-tests and McNemar's tests were used to assess changes in hospitalization incidence and duration. Stepwise Cox proportional hazards models assessed factors associated with hospitalizations. Analyses were based on data from the first 3 years of the continuously enrolling study (N = 668). The average duration of olanzapine LAI exposure for all patients was 0.768 years. Of the 529 patients who received at least 1 injection of olanzapine LAI and were not hospitalized at study entry, 8.1% had at least 1 subsequent psychiatric hospitalization with a mean duration of 2.0 days. Of the 288 patients who had a >6-month follow-up, 8.3% had at least 1 post-baseline psychiatric hospitalization with a mean duration of 2.3 days. The incidence of hospitalizations in the 6-month period after treatment was significantly lower than that in the 6-month period prior to treatment (8.3 vs 32.6%, respectively; P < 0.001). Furthermore, mean hospitalization duration decreased from 11.5 days in the 6-month period before treatment to 2.3 days in the 6-month period after treatment (P < 0.001). Psychiatric

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

    PubMed

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

    2003-10-01

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

  14. Safety of Adding Oats to a Gluten-Free Diet for Patients With Celiac Disease: Systematic Review and Meta-analysis of Clinical and Observational Studies.

    PubMed

    Pinto-Sánchez, María Inés; Causada-Calo, Natalia; Bercik, Premysl; Ford, Alexander C; Murray, Joseph A; Armstrong, David; Semrad, Carol; Kupfer, Sonia S; Alaedini, Armin; Moayyedi, Paul; Leffler, Daniel A; Verdú, Elena F; Green, Peter

    2017-08-01

    Patients with celiac disease should maintain a gluten-free diet (GFD), excluding wheat, rye, and barley. Oats might increase the nutritional value of a GFD, but their inclusion is controversial. We performed a systematic review and meta-analysis to evaluate the safety of oats as part of a GFD in patients with celiac disease. We searched the Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE databases for clinical trials and observational studies of the effects of including oats in GFD of patients with celiac disease. The studies reported patients' symptoms, results from serology tests, and findings from histologic analyses. We used the GRADE approach to assess the quality of evidence. We identified 433 studies; 28 were eligible for analysis. Of these, 6 were randomized and 2 were not randomized controlled trials comprising a total of 661 patients-the remaining studies were observational. All randomized controlled trials used pure/uncontaminated oats. Oat consumption for 12 months did not affect symptoms (standardized mean difference: reduction in symptom scores in patients who did and did not consume oats, -0.22; 95% CI, -0.56 to 0.13; P = .22), histologic scores (relative risk for histologic findings in patients who consumed oats, 0.24; 95% CI, 0.01-4.8; P = .35), intraepithelial lymphocyte counts (standardized mean difference, 0.21; 95% CI, reduction of 1.44 to increase in 1.86), or results from serologic tests. Subgroup analyses of adults vs children did not reveal differences. The overall quality of evidence was low. In a systematic review and meta-analysis, we found no evidence that addition of oats to a GFD affects symptoms, histology, immunity, or serologic features of patients with celiac disease. However, there were few studies for many endpoints, as well as limited geographic distribution and low quality of evidence. Rigorous double-blind, placebo-controlled, randomized controlled trials, using commonly available oats sourced from

  15. 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

  16. Safety and effectiveness of bevacizumab-containing treatment for non-small-cell lung cancer: final results of the ARIES observational cohort study.

    PubMed

    Lynch, Thomas J; Spigel, David R; Brahmer, Julie; Fischbach, Neal; Garst, Jennifer; Jahanzeb, Mohammad; Kumar, Priya; Vidaver, Regina M; Wozniak, Antoinette J; Fish, Susan; Flick, E Dawn; Leon, Larry; Hazard, Sebastien J; Kosty, Michael P

    2014-09-01

    Bevacizumab, a recombinant humanized monoclonal antibody against vascular endothelial growth factor, was approved by the US Food and Drug Administration for the treatment of advanced non-small-cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel. ARIES (Avastin Regimens: Investigation of Effectiveness and Safety), a prospective observational cohort study, evaluated outcomes in a large, community-based population of patients with first-line NSCLC. From 2006 to 2009, ARIES enrolled patients with locally advanced or metastatic NSCLC who were eligible for bevacizumab, excluding those with predominantly squamous histology. Patients were required to provide informed consent and to have initiated bevacizumab with chemotherapy within 4 months before enrollment. There were no protocol-defined treatments or assessments. The dosing of bevacizumab and chemotherapy, and the choice of chemotherapy regimen, was at the discretion of the treating physician. ARIES enrolled 1967 patients with first-line NSCLC. At study closure, median follow-up was 12.5 months (range, 0.2-65.5). Median age was 65 years (range, 31-93), and 252 patients (12.8%) identified as never smokers. Median progression-free survival was 6.6 months (95% confidence interval, 6.3-6.9), and median overall survival was 13.0 months (95% confidence interval, 12.2-13.8) with first-line bevacizumab plus chemotherapy. Incidences of bevacizumab-associated adverse events (19.7% overall) were consistent with those in randomized controlled trials of bevacizumab in NSCLC. Results from ARIES demonstrate similar outcomes to randomized controlled trials of bevacizumab when added to standard chemotherapy in a real-world patient population with advanced NSCLC.

  17. 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.

  18. A methodological study to compare survey-based and observation-based evaluations of organisational and safety cultures and then compare both approaches with markers of the quality of care.

    PubMed

    Freeth, D; Sandall, J; Allan, T; Warburton, F; Berridge, E J; Mackintosh, N; Rogers, M; Abbott, S

    2012-05-01

    Patient safety concerns have focused attention on organisational and safety cultures, in turn directing attention to the measurement of organisational and safety climates. First, to compare levels of agreement between survey- and observation-based measures of organisational and safety climates/cultures and to compare both measures with criterion-based audits of the quality of care, using evidence-based markers drawn from national care standards relating to six common clinical conditions. (This required development of an observation-based instrument.) Second, to examine whether observation-based evaluations could replace or augment survey measurements to mitigate concerns about declining response rates and increasing social desirability bias. Third, to examine mediating factors in safety and organisational climate scores. The study had three strands: (A) a postal questionnaire survey to elicit staff perceptions of organisational and safety climates, using six prevalidated scales; (B) semistructured non-participant observation of clinical teams; and (C) a retrospective criterion-based audit carried out by non-clinical auditors to minimise hindsight bias. Standardised summary scores were created for each strand, and pairs of measurements were compared (strand A with strand B, strand A with strand C, and strand B with strand C) using Bland-Altman plots to evaluate agreement. Correlations were also examined. Multilevel modelling of Strand A scores explored mediating factors. Eight emergency departments and eight maternity units in England, UK. None. Examination of feasibility, correlation and agreement. Strand A: the overall response rate was 27.6%, whereas site-specific rates ranged from 9% to 47%. We identified more mediating factors than previous studies; variable response rates had little effect on the results. Organisational and safety climate scores were strongly correlated (r = 0.845) and exhibited good agreement [standard deviation (SD) differences 0.449; 14 (88

  19. 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

  20. Treatment outcomes in a safety observational study of dihydroartemisinin/piperaquine (Eurartesim(®)) in the treatment of uncomplicated malaria at public health facilities in four African countries.

    PubMed

    Adjei, Alexander; Narh-Bana, Solomon; Amu, Alberta; Kukula, Vida; Nagai, Richard Afedi; Owusu-Agyei, Seth; Oduro, Abraham; Macete, Eusebio; Abdulla, Salim; Halidou, Tinto; Sie, Ali; Osei, Isaac; Sevene, Esperance; Asante, Kwaku-Poku; Mulokozi, Abdunoor; Compaore, Guillaume; Valea, Innocent; Adjuik, Martin; Baiden, Rita; Ogutu, Bernhards; Binka, Fred; Gyapong, Margaret

    2016-01-27

    Dihydroartemisinin-piperaquine (DHA-PQ) is one of five WHO recommended artemisinin combination therapy (ACT) for the treatment of uncomplicated malaria. However, little was known on its post-registration safety and effectiveness in sub-Saharan Africa. DHA-PQ provides a long post-treatment prophylactic effect against re-infection; however, new infections have been reported within a few weeks of treatment, especially in children. This paper reports the clinical outcomes following administration of DHQ-PQ in real-life conditions in public health facilities in Burkina Faso, Ghana, Mozambique, and Tanzania for the treatment of confirmed uncomplicated malaria. An observational, non-comparative, longitudinal study was conducted on 10,591 patients with confirmed uncomplicated malaria visiting public health facilities within seven health and demographic surveillance system sites in four African countries (Ghana, Tanzania, Burkina Faso, Mozambique) between September 2013 and April 2014. Patients were treated with DHA-PQ based on body weight and followed up for 28 days to assess the clinical outcome. A nested cohort of 1002 was intensely followed up. Clinical outcome was assessed using the proportion of patients who reported signs and symptoms of malaria after completing 3 days of treatment. A total of 11,097 patients were screened with 11,017 enrolled, 94 were lost to follow-up, 332 withdrew and 10,591 (96.1%) patients aged 6 months-85 years met protocol requirements for analysis. Females were 52.8 and 48.5% were <5 years of age. Malaria was diagnosed by microscopy and rapid diagnostic test in 69.8% and 29.9%, respectively. At day 28, the unadjusted risk of recurrent symptomatic parasitaemia was 0.5% (51/10,591). Most of the recurrent symptomatic malaria patients (76%) were children <5 years. The mean haemoglobin level decreased from 10.6 g/dl on day 1 to 10.2 g/dl on day 7. There was no significant renal impairment in the nested cohort during the first 7 days of follow

  1. 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.

  2. Patient Safety Incidents in Hospice Care: Observations from Interdisciplinary Case Conferences

    PubMed Central

    Demiris, George; Wittenberg-Lyles, Elaine; Gage, Ashley; Dewsnap-Dreisinger, Mariah L.; Luetkemeyer, Jamie

    2013-01-01

    Background: In the home hospice environment, issues arise every day presenting challenges to the safety, care, and quality of the dying experience. The literature pertaining to the safety challenges in this environment is limited. Aim: The study explored two research questions; 1) What types of patient safety incidents occur in the home hospice setting? 2) How many of these incidents are recognized by the hospice staff and/or the patient or caregiver as a patient safety incident? Design and Methods: Video-recordings of hospice interdisciplinary team case conferences were reviewed and coded for patient safety incidents. Patient safety incidents were defined as any event or circumstance that could have resulted or did result in unnecessary harm to the patient or caregiver, or that could have resulted or did result in a negative impact on the quality of the dying experience for the patient. Codes for categories of patient safety incidents were based on the International Classification for Patient Safety. Setting/Participants: The setting for the study included two rural hospice programs in one Midwestern state in the United States. One hospice team had two separately functioning teams, the second hospice had three teams. Results: 54 video-recordings were reviewed and coded. Patient safety incidents were identified that involved issues in clinical process, medications, falls, family or caregiving, procedural problems, documentation, psychosocial issues, administrative challenges and accidents. Conclusion: This study distinguishes categories of patient safety events that occur in home hospice care. Although the scope and definition of potential patient safety incidents in hospice is unique, the events observed in this study are similar to those observed with in other settings. This study identifies an operating definition and a potential classification for further research on patient safety incidents in hospice. Further research and consensus building of the definition

  3. Patient safety incidents in hospice care: observations from interdisciplinary case conferences.

    PubMed

    Oliver, Debra Parker; Demiris, George; Wittenberg-Lyles, Elaine; Gage, Ashley; Dewsnap-Dreisinger, Mariah L; Luetkemeyer, Jamie

    2013-12-01

    In the home hospice environment, issues arise every day presenting challenges to the safety, care, and quality of the dying experience. The literature pertaining to the safety challenges in this environment is limited. The study explored two research questions; 1) What types of patient safety incidents occur in the home hospice setting? 2) How many of these incidents are recognized by the hospice staff and/or the patient or caregiver as a patient safety incident? Video-recordings of hospice interdisciplinary team case conferences were reviewed and coded for patient safety incidents. Patient safety incidents were defined as any event or circumstance that could have resulted or did result in unnecessary harm to the patient or caregiver, or that could have resulted or did result in a negative impact on the quality of the dying experience for the patient. Codes for categories of patient safety incidents were based on the International Classification for Patient Safety. The setting for the study included two rural hospice programs in one Midwestern state in the United States. One hospice team had two separately functioning teams, the second hospice had three teams. 54 video-recordings were reviewed and coded. Patient safety incidents were identified that involved issues in clinical process, medications, falls, family or caregiving, procedural problems, documentation, psychosocial issues, administrative challenges and accidents. This study distinguishes categories of patient safety events that occur in home hospice care. Although the scope and definition of potential patient safety incidents in hospice is unique, the events observed in this study are similar to those observed with in other settings. This study identifies an operating definition and a potential classification for further research on patient safety incidents in hospice. Further research and consensus building of the definition of patient safety incidents and patient safety incidents in this setting is

  4. A retrospective review and observational study of outcomes and safety of bimatoprost ophthalmic solution 0.03% for treating eyelash hypotrichosis.

    PubMed

    Yoelin, Steven G; Fagien, Steven; Cox, Sue Ellen; Davis, Paula G; Campo, Antoinette; Caulkins, Carrie A; Gallagher, Conor J

    2014-10-01

    The efficacy and safety of bimatoprost ophthalmic solution 0.03% for treating hypotrichosis were shown in a randomized controlled trial and in an open-label study. To date, no data on real-world experience have been published. To evaluate long-term patient satisfaction, usage patterns, and safety of bimatoprost 0.03% in clinical practice. In this retrospective chart review with a cross-sectional design, adult patients exposed to bimatoprost 0.03% for at least 12 months were randomly sampled from 16 investigational sites. Charts were reviewed for medication usage characteristics and adverse events (AEs). At a study visit, questionnaires eliciting patient-reported outcomes were administered and spontaneously reported AEs were tabulated. Analysis included 585 subjects with a mean (SD) treatment duration of 19.3 (4.3) months. Patient satisfaction with bimatoprost 0.03% was 92.5%; on average, approximately 3 applications per week maintained benefits. Overall, 27.4% of patients spontaneously recalled experiencing AEs while on treatment; however, patient charts showed that only 4 AEs were documented. No instances of iris hyperpigmentation occurred. No serious or severe AEs were noted. Treatment with bimatoprost 0.03% for at least 12 months is safe, and long-term use is associated with a high degree of satisfaction.

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

    PubMed

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

    2016-08-01

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

  6. Immunogenicity and safety of the bivalent HPV vaccine in female patients with juvenile idiopathic arthritis: a prospective controlled observational cohort study.

    PubMed

    Heijstek, Marloes W; Scherpenisse, Mirte; Groot, Noortje; Tacke, Carline; Schepp, Rutger M; Buisman, Anne-Marie; Berbers, Guy A M; van der Klis, Fiona R M; Wulffraat, Nico M

    2014-08-01

    To compare the immunogenicity and safety of the bivalent human papillomavirus (HPV)16/18 vaccine between female patients with juvenile idiopathic arthritis (JIA) and healthy female adolescents. 68 patients and 55 healthy girls aged 12-18 years were included in a prospective controlled observational cohort and were vaccinated at 0, 1 and 6 months. Primary outcomes were immunogenicity expressed as seropositivity rate after three vaccine doses at 7 and 12 months and HPV-specific geometric mean antibody concentrations. Secondary outcomes were HPV16/18-specific memory B cell responses in a subset of participants and safety, defined as adverse events and the effect of vaccination on JIA disease activity. All participants were seropositive for HPV16 and HPV18 at 7 months. One patient turned seronegative at 12 months for HPV16/18. No significant differences were found between patients and controls in HPV-specific antibody concentrations; however, antibody concentrations were consistently lower in patients. No effect of methotrexate on HPV16 antibodies (p=0.79) or HPV18 antibodies (p=0.37) was detected. All patients on anti-TNFα treatment were seropositive after vaccination. The kinetics of HPV16/18 memory B cell responses was comparable between patients and controls, but the magnitude of B cell responses at 7 and 12 months appeared lower in patients. No relevant differences in adverse events were found. HPV vaccination did not aggravate JIA disease. The bivalent HPV16/18 vaccine is immunogenic and well tolerated in JIA patients. However, HPV-specific antibodies and B cell responses tended to be lower in patients compared with healthy controls. NCT00815282. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  7. Supplementary safety system corrosion studies

    SciTech Connect

    Anderson, M.H.; Wiersma, B.J.

    1991-05-21

    This memorandum presents experimental data from electrochemical and immersion tests to support the continued use of two sections of nonconforming steel in the Supplementary Safety System. The Reactor Corrosion Mitigation Committee met on May 16, 1991 to evaluate materials that had been installed in the SSS. The materials lacked complete Corrosion Evaluation (CE) and/or Certified Mill Test Reports and had been installed during recent modifications (Project S-4332). Items that lacked proper documentation included AISI Type 304 stainless steel (304) instrument tubing (0.375'' OD) associated with the pressure transmitters and a two-foot section of 304 pipe located on the far side of the system downstream of the pneumatic valves. Cyclic potentiodynamic polarization scans were performed on sensitized and solution-annealed 304 samples in as-mixed and acidified Gd(NO{sub 3}){sub 3}, or ink'', solutions at room temperature to determine the susceptibility of 304 to localized corrosion in this environment. No localized attack was observed on the solution annealed or sensitized 304 in the Gd(NO{sub 3}){sub 3} solution. These tests revealed no significant differences in the behavior of the sensitized and solution-annealed 304 in gadolinium nitrate solution. Therefore, localized corrosion of the nonconforming components is not anticipated, and the performance of the nonconforming components should not differ from that of corrosion evaluated and certified materials. Previous studies have shown that AISI Type 304L stainless steel (304L) did not pit during a three-month exposure in gadolinium nitrate solutions of pH 2 or 5. These combined results support the continued use of the nonconforming steels until replacement can be made at the next scheduled long shut-down.

  8. Supplementary safety system corrosion studies

    SciTech Connect

    Anderson, M.H.; Wiersma, B.J.

    1991-05-21

    This memorandum presents experimental data from electrochemical and immersion tests to support the continued use of two sections of nonconforming steel in the Supplementary Safety System. The Reactor Corrosion Mitigation Committee met on May 16, 1991 to evaluate materials that had been installed in the SSS. The materials lacked complete Corrosion Evaluation (CE) and/or Certified Mill Test Reports and had been installed during recent modifications (Project S-4332). Items that lacked proper documentation included AISI Type 304 stainless steel (304) instrument tubing (0.375`` OD) associated with the pressure transmitters and a two-foot section of 304 pipe located on the far side of the system downstream of the pneumatic valves. Cyclic potentiodynamic polarization scans were performed on sensitized and solution-annealed 304 samples in as-mixed and acidified Gd(NO{sub 3}){sub 3}, or ``ink``, solutions at room temperature to determine the susceptibility of 304 to localized corrosion in this environment. No localized attack was observed on the solution annealed or sensitized 304 in the Gd(NO{sub 3}){sub 3} solution. These tests revealed no significant differences in the behavior of the sensitized and solution-annealed 304 in gadolinium nitrate solution. Therefore, localized corrosion of the nonconforming components is not anticipated, and the performance of the nonconforming components should not differ from that of corrosion evaluated and certified materials. Previous studies have shown that AISI Type 304L stainless steel (304L) did not pit during a three-month exposure in gadolinium nitrate solutions of pH 2 or 5. These combined results support the continued use of the nonconforming steels until replacement can be made at the next scheduled long shut-down.

  9. 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.

  10. 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

  11. Efficacy, safety, and effect on sexual behaviour of on-demand pre-exposure prophylaxis for HIV in men who have sex with men: an observational cohort study.

    PubMed

    Molina, Jean-Michel; Charreau, Isabelle; Spire, Bruno; Cotte, Laurent; Chas, Julie; Capitant, Catherine; Tremblay, Cecile; Rojas-Castro, Daniela; Cua, Eric; Pasquet, Armelle; Bernaud, Camille; Pintado, Claire; Delaugerre, Constance; Sagaon-Teyssier, Luis; Mestre, Soizic Le; Chidiac, Christian; Pialoux, Gilles; Ponscarme, Diane; Fonsart, Julien; Thompson, David; Wainberg, Mark A; Doré, Veronique; Meyer, Laurence

    2017-09-01

    Data for on-demand pre-exposure prophylaxis (PrEP) are scarce. We implemented a cohort study to assess its efficacy, safety, and effect on sexual behaviour. We invited men and transgender women who have sex with men, previously enrolled in the randomised placebo-controlled ANRS IPERGAY trial at seven sites (six in France and one in Canada), to participate in an open-label extension with on-demand tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg) to be taken before and after sexual intercourse. We assessed the incidence of HIV and other sexually transmitted infections (STIs), PrEP adherence, safety, and sexual behaviour. Statistical analyses included comparisons of proportions and incidence between the randomised phase of the ANRS IPERGAY trial and the open-label phase, and all participants were included in safety analyses. ANRS IPERGAY is registered with ClinicalTrials.gov, number NCT01473472. Between Nov 4, 2014, and Jan 27, 2015, we enrolled 361 participants. Median follow-up was 18·4 months (IQR 17·7-19·1). One participant who discontinued PrEP acquired HIV infection. HIV incidence was 0·19 per 100 person-years (95% CI 0·01-1·08), compared with 6·60 per 100 person-years (3·60-11·05) in the placebo group of the randomised study, indicating a relative reduction of 97% (95% CI 81-100) in the incidence of HIV with on-demand PrEP. Participants used a median of 18 pills of study drugs per month (IQR 11-25), and at the 6 month visit 240 (71%) of 336 participants had tenofovir detected in plasma. Drug-related gastrointestinal events were reported in 49 participants (14%) but were self-limited. Only four participants (1%) discontinued PrEP, three because of an increase in plasma creatinine. The proportion of participants reporting condomless sex at their last receptive anal intercourse significantly increased from 77% (136 of 176 participants) at baseline to 86% (66 of 77 participants) at 18 months' follow-up (p for trend=0·0004). The incidence

  12. Compliance and safety of a novel home exercise program for patients with high-grade brain tumors, a prospective observational study.

    PubMed

    Baima, Jennifer; Omer, Zehra B; Varlotto, John; Yunus, Shakeeb

    2017-09-01

    The purpose of this study is to evaluate compliance with and safety of a novel independent home exercise program for patients with high-grade brain tumors. We designed this program around the preferences and individual capabilities of this population as well as the potential barriers to exercise in cancer patients. Demographics were collected to better understand those that persisted with exercise. Subjects with high-grade brain tumor received one-time training that included watching an exercise video and live demonstration of resistance band exercises, a balance exercise, and recommendations for walking. Subjects were instructed to do the exercises every day for 1 month. Main outcome measures were percentage of subjects who exercised throughout the month, frequency of exercising, demographic factors, quality of life scores (assessed by FACT-BR), and self report of adverse events. Fourteen of the 15 (93%) subjects started the exercises during the course of the month. Nine of the fifteen (60%) continued the exercises throughout the month. Three additional subjects would have continued to exercise if formal or supervised rehabilitation had been offered. Among the subjects who continued the exercises regularly, higher frequency of exercising was significantly associated with living as married (p = 0.033), annual income >$50,000 (p = 0.047), scores of physical well-being (p = 0.047), and brain cancer specific well-being (p = 0.054) subscales. Among those who exercised frequently, there was also a trend towards increase in total FACT-BR scores (p = 0.059). The subjects who scored higher on the social well-being subscale of the FACT-BR at baseline self-reported a higher likelihood to continue the exercises after 1 month of participation in the study (p = 0.018). No adverse events were reported. Our small group of subjects with high-grade brain tumors demonstrated compliance with and safety of a novel independent strength and balance exercise program in the

  13. Safety profile of fast-track extubation in pediatric congenital heart disease surgery patients in a tertiary care hospital of a developing country: An observational prospective study.

    PubMed

    Akhtar, Mohammad Irfan; Hamid, Mohammad; Minai, Fauzia; Wali, Amina Rehmat; Anwar-Ul-Haq; Aman-Ullah, Muneer; Ahsan, Khalid

    2014-07-01

    Early extubation after cardiac operations is an important aspect of fast-track cardiac anesthesia. In order to reduce or eliminate the adverse effects of prolonged ventilation in pediatric congenital heart disease (CHD) surgical patients, the concept of early extubation has been analyzed at our tertiary care hospital. The current study was carried out to record the data to validate the importance and safety of fast-track extubation (FTE) with evidence. A total of 71 patients, including male and female aged 6 months to 18 years belonging to risk adjustment for congenital heart surgery-1 category 1, 2, and 3 were included in this study. All patients were anesthetized with a standardized technique and surgery performed by the same surgeon. At the end of operation, the included patients were assessed for FTE and standard extubation criteria were used for decision making. Of the total 71 patients included in the study, 26 patients (36.62%) were extubated in the operating room, 29 (40.85%) were extubated within 6 h of arrival in cardiovascular intensive care unit and 16 (22.54%) were unable to get extubated within 6 h due to multiple reasons. Hence, overall success rate was 77.47%. The reasons for delayed extubation were significant bleeding in 5 (31.3%) cases, hemodynamic instability (low cardiac output syndrome) in 4 (25%) cases, respiratory complication in 2 (12.5%), bleeding plus hemodynamic instability in 2 (12.5) cases, hemodynamic instability, and respiratory complication in 2 (12.5%) cases and triad of hemodynamic instability, bleeding and respiratory complication in 1 (6.5%) case. There was no reintubation in the FTE cases. On the basis of the current study results, it is recommended to use FTE in pediatric CHD surgical patients safely with multidisciplinary approach.

  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. Efficacy, safety, and tolerability of pantoprazole magnesium in the treatment of reflux symptoms in patients with gastroesophageal reflux disease (GERD): a prospective, multicenter, post-marketing observational study.

    PubMed

    Remes-Troche, José María; Sobrino-Cossío, Sergio; Soto-Pérez, Julio César; Teramoto-Matsubara, Oscar; Morales-Arámbula, Miguel; Orozco-Gamiz, Antonio; Tamayo de la Cuesta, José Luis; Mateos, Gualberto

    2014-02-01

    To improve proton pump inhibitor effects, pharmacological modifications have been developed such as the use of enantiomer molecules (e.g., S-omeprazole, S-pantoprazole, or dexlansoprazole), or addition of NaHCO3 (for an immediate release) or magnesium (with a lower absorption for a more sustained effect). The objective of this study was to assess the efficacy, safety, and tolerability of pantoprazole magnesium 40 mg once daily for 4 weeks, on the relief of reflux symptoms in gastroesophageal reflux disease (GERD) patients. A phase IV, open-label, prospective, multicenter study was designed. Patients included were prescribed pantoprazole magnesium 40 mg orally once daily for 28±2 days. All patients had a history of persistent or recurrent heartburn and/or acid regurgitation for at least 3 months. Effectiveness and tolerability data obtained from patients who completed a minimum of 4 weeks of pantoprazole magnesium treatment were considered for analysis. The account of baseline characteristics and demographics of GERD symptom intensity was made by analyzing the group of 4,343 patients that fulfilled all inclusion criteria; 54% were females (n=2,345) and 46% (n=1,998) males, with a mean age of 36.2±7.5 years. Severity of symptoms, assessed by the physician using the 4-point Likert scale, reduced by at least 80% from baseline intensity after treatment in the per protocol population. In the case of the intention-to-treat population, the improvement in symptom intensity was 73%. The number of patients that experienced any adverse events was 175/5,027 (3.48%). Pantoprazole magnesium is a safe, effective, and well-tolerated drug that significantly improves GERD symptoms.

  16. Safety, efficacy, and patient-perceived satisfaction of peripherally inserted central catheters in terminally ill cancer patients: a prospective multicenter observational study.

    PubMed

    Park, Kwonoh; Jun, Hyun Jung; Oh, So Yeon

    2016-12-01

    The purpose of this study was to investigate the safety, efficacy, and subjective satisfaction of peripherally inserted central catheters (PICCs) in terminally ill cancer patients. All PICCs were inserted by an interventional radiologist with radiological guidance. We monitored the occurrence of PICC-related complication and evaluated the patient-perceived satisfaction for PICC using semi-structured questionnaire. A total of 36 terminally ill cancer patients underwent PICC. Three patients had 2 PICC insertions; hence, finally 39 episodes during 829 PICC days were analyzed. All procedures were completed without any procedure-related complication. The median catheter life span was 19.0 days (95 % CI, 14.1-23.9). Thirty-four cases maintained the PICC until the intended time, while the other 5 cases (12.8 %; 6.1/1000 PICC days) were premature PICC removals. Totally 10 complications (25.6 %; 12.3/1000 PICC days) were reported including premature removals (n = 5), trivial bleedings (n = 3), and thrombophlebitis (n = 2). Patients reported that the procedure was not distressing (42 %), a little distressing (36 %), or distressing (21 %). Of 30 patients who had preserved cognitive function at fifth day, most patients (n = 25, 83 %) reported more comfort although the other 5 patients reported no change (n = 3) or less comfort (n = 2). PICCs were safely inserted and showed favorable maintenance rate with acceptable complications. Additionally, most of the patients felt that parenteral access became much comfortable after PICC insertion. When considering the characteristics of terminally ill cancer patients, poor general condition and a limited period of survival, PICC could be a safe and effective method for intravenous access.

  17. 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.

  18. 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

  19. Safety of poly-L-lactic acid (New-Fill®) in the treatment of facial lipoatrophy: a large observational study among HIV-positive patients.

    PubMed

    Duracinsky, Martin; Leclercq, Pascale; Herrmann, Susan; Christen, Marie-Odile; Dolivo, Marc; Goujard, Cécile; Chassany, Olivier

    2014-09-01

    Facial lipoatrophy is a frequently reported condition associated with use of antiretroviral (ARV) drugs. Poly-L-lactic acid (PLLA) acid has been used to correct facial lipoatrophy in people with HIV since 2004 both in Europe and the United States. The objective of this study was to establish, in real life conditions and in a large sample, the safety of PLLA (New Fill®, Valeant US, Sinclair Pharma Paris, France) to correct facial lipoatrophy among HIV-positive patients. A longitudinal study was conducted between 2005 and 2008 in France. Data from 4,112 treatment courses (n = 4,112 patients) and 15,665 injections sessions (1 to 5 injection sessions per treatment course) were gathered by 200 physicians trained in the use of PLLA. The average age of patients (88.3% males) treated for lipoatrophy was 47.1 ± 8.1 years (Mean ± SD); 91.2% of patients had been receiving ARV treatment for 10.9 (±4.2) years; CD4 T-cell count was 535 ± 266 cells/mm3. The duration of facial lipoatrophy was 5 ± 2.8 years and the severity was such that 47.3% of patients required five injection sessions of PLLA and 81.9% of the sessions required two vials of the preparation. The final visit, scheduled two months after the last injection session, was attended by 66.0% of patients (n = 2,713). 48 treatment courses (2.8%) were discontinued due to adverse events (AEs). The overall incidence of AEs per course was 18.8%. Immediate AEs, bleeding (3.4%), bruising (2.3%), pain (2.0%), redness at injection site (1.6%), and swelling of the face (0.7%), occurred in 15.4% of courses and 7.0% of sessions (usually during the first session). Non-immediate AEs, mainly nodules (5.7%), inflammation (0.7%), granuloma (0.3%), discolouration (0.2%), and skin hypertrophy (0.1%), occurred in 6.7% of courses. Non-immediate AEs occurred within a time ranging from 21 days (inflammation) to 101 days (granuloma) and all but three of the 13 cases of granuloma resolved. Product efficacy was

  20. Effectiveness, safety and health-related quality of life of multiple sclerosis patients treated with fingolimod: results from a 12-month, real-world, observational PERFORMS study in the Middle East.

    PubMed

    Achiron, Anat; Aref, Hany; Inshasi, Jihad; Harb, Mohamad; Alroughani, Raed; Bijarnia, Mahendra; Cooke, Kathryn; Yuksel, Ozgur

    2017-08-07

    Evidence on the use of fingolimod in real-world clinical practice and data on patient-reported health-related quality of life (HRQoL) in countries such as the Middle East are sparse. The Prospective Evaluation of Treatment with Fingolimod for Multiple Sclerosis (PERFORMS) study assessed HRQoL and effectiveness and safety of fingolimod in patients with relapsing-remitting multiples sclerosis (RRMS), primarily in Middle Eastern countries. This 12-month, observational, multicentre, prospective, real-world study was conducted in patients with RRMS who initiated fingolimod or another approved disease-modifying treatment (DMT) within 4 weeks before study entry. Patients were enrolled in a 2:1 ratio to obtain more data in fingolimod and parallel in other DMTs cohort by physicians during routine medical care. Key study outcomes included HRQoL assessed using MS International QoL (MusiQoL), MS relapses and disability. Safety was assessed throughout the study period. Due to the observational nature of the study, no neuroimaging assessments were mandated and central reading was not performed. Of 249 enrolled patients, 247 were included in the analysis (fingolimod cohort 172; other DMTs cohort 75). Overall, the mean age of patients was 36.5 years, 64.4% were women and ~90% were Caucasians. At baseline, mean MS duration since diagnosis was 7.2 years in the fingolimod and 4.8 years in the other DMTs cohorts. Overall, mean changes in MusiQoL index scores were -2.1 in the fingolimod cohort and -0.7 in the other DMTs cohort at Month 12, but improvement was not significant vs. baseline in both cohorts. Proportion of relapse-free patients increased significantly during the study vs. 0-12 months before the study in the fingolimod cohort (80.2% vs. 24.4%; p < 0.0001). Proportion of patients free from disability progression was 86.5% in the fingolimod cohort. The incidences of AEs were 59.9% and 50.6% in the fingolimod and other DMTs cohorts, respectively. First-dose monitoring of

  1. Maternal quality and safety outcomes for Asians and Pacific Islanders in Hawai'i: an observational study from five years of statewide data.

    PubMed

    Sentell, Tetine; Chang, Ann; Cheng, Yongjun; Miyamura, Jill

    2014-08-30

    Empirical evidence regarding maternal quality and safety outcomes across heterogeneous Asian and Pacific Islanders subgroups in the United States is limited, despite the importance of this topic to health disparities research and quality improvement efforts. Detailed discharge data from all Hawai'i childbirth hospitalizations (n = 75,725) from 2008 to 2012 were considered. Validated measures of maternal quality and safety were compared in descriptive and multivariable models across seven racial/ethnic groups: Filipino, Native Hawaiian, other Pacific Islander (e.g., Samoan, Tongan, Micronesian), Japanese, Chinese, white, and other race/ethnicity. Multivariable models adjusted for age group, payer, rural vs. urban hospital location, multiple gestation, and high-risk pregnancy. Compared to whites, Japanese, Filipinos, and Other Pacific Islanders had significantly higher overall delivery complication rates while Native Hawaiians had significantly lower rates. Native Hawaiians also had significantly lower rates of obstetric trauma in vaginal delivery with and without instruments compared to whites (Rate Ratio (RR):0.66; 95% CI:0.50-0.87 and RR:0.62; 95% CI:0.52-0.74, respectively). Japanese and Chinese had significantly higher rates of obstetric trauma for vaginal deliveries without instruments (RR:1.52; 95% CI:1.27-1.81 and RR:1.95;95% CI:1.53-2.48, respectively) compared to whites, and Chinese also had significantly higher rates of birth trauma in vaginal delivery with instrument (RR 1.42; 95% CI:1.06-1.91). Filipinos and Other Pacific Islanders had significantly higher rates of Cesarean deliveries compared to whites (RR:1.15; 95% CI:1.11-1.20 and RR:1.16; 95% CI:1.10-1.22, respectively). Other Pacific Islanders also had significantly higher rates of vaginal births after Cesarean (VBAC) deliveries compared to whites (RR: 1.28; 95% CI:1.08-1.51) and Japanese had significantly lower rates of uncomplicated VBACs (RR:0.77; 95% CI:0.63-0.94). Significant variation was seen

  2. 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

  3. Safety and Immunogenicity of Cell Culture-Derived A/H3N2 Variant Influenza Vaccines: A Phase I Randomized, Observer-Blind, Dose-Ranging Study

    PubMed Central

    Johnson, Casey; Hohenboken, Matthew; Poling, Terry; Jaehnig, Peter; Kanesa-thasan, Niranjan

    2015-01-01

    Background. A/H3N2 variant (H3N2v) influenza may sustain human-to-human transmission, and an available candidate vaccine would be important. Methods. In this phase I, randomized, observer-blind, dose-ranging study, 627 healthy subjects ≥3 years of age were randomized to receive 2 vaccinations with H3N2c cell-culture-derived vaccine doses containing 3.75 µg, 7.5 µg, or 15 µg hemagglutinin antigen of H3N2v with or without MF59 (registered trademark of Novartis AG) adjuvant (an oil-in-water emulsion). This paper reports Day 43 planned interim data. Results. Single MF59-adjuvanted H3N2c doses elicited immune responses in almost all subjects regardless of antigen and adjuvant dose; the Center for Biologics Evaluation Research and Review (CBER) licensure criteria were met for all groups. Subjects with prevaccination hemagglutination inhibition titers <10 and children 3–<9 years achieve CBER criteria only after receiving 2 doses of nonadjuvanted H3N2c vaccine. Highest antibody titers were observed in the 7.5 µg + 0.25 mL MF59 groups in all age cohorts. MF59-adjuvanted H3N2c vaccines showed the highest rates of solicited local and systemic events, predominately mild or moderate. Conclusions. A single dose of H3N2c vaccine may be immunogenic and supports further development of MF59-adjuvanted H3N2c vaccines, especially for pediatric populations. Clinical Trials Registration. ClinicalTrials.gov identifier NCT01855945 (http://clinicaltrials.gov/ct2/show/NCT01855945). PMID:25538277

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

    PubMed Central

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

    2010-01-01

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

  5. 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.

  6. 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

  7. 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.

  8. 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: the Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) study report 5.

    PubMed

    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

    2009-09-01

    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). Multicenter, randomized, clinical trial of 271 participants. Gain in visual acuity letter score of 15 or more from baseline to month 12. 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. 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.

  9. 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.

  10. 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

  11. 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

  12. 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.

  13. 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.

  14. Observation and measurement of hand hygiene and patient identification improve compliance with patient safety practices.

    PubMed

    Rosenthal, Tom; Erbeznik, Mary; Padilla, Tony; Zaroda, Teresa; Nguyen, Daniel H; Rodriguez, Marcela

    2009-12-01

    Measurement, a crucial step in any quality improvement activity, is difficult in two important patient safety processes: hand hygiene and patient identification. This study describes a program at the UCLA Medical Center, called Measure to Achieve Patient Safety (MAPS), which uses undergraduate student volunteers to carry out observations in the hospital. This program has been an important part of UCLA's efforts for quality improvement in patient safety efforts. Since 2004, approximately 20 students per year plus two student leaders have been selected to participate in the MAPS program. They were trained in techniques of measuring and observation and in professional behavior. They participated in weekly and monthly meetings with program leadership, received continuing education from the UCLA patient safety staff, and were trained in observational measurement. The students' observational results have been systematically reported to clinicians and departmental and hospital leadership. Handwashing increased from 50% to 93%, and nurses' checking of two identifiers at the time of medication administration increased from 50% to 95%. Compliance with proper patient identification at the time of nurse-to-transporter handoffs of patients for procedures increased to >90%. This unique program has made a significant contribution to UCLA's quality, safety, and service programs. MAPS has been widely accepted by the clinical staff and has also been valuable to the student volunteers. Such an approach is easily adaptable to other academic medical centers.

  15. 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.

  16. The Effectiveness and Safety of Thermocoagulation Radiofrequency Treatment of the Ophthalmic Division (V1) and/or Maxillary (V2) and Mandibular (V3) Division in Idiopathic Trigeminal Neuralgia: An Observational Study.

    PubMed

    Huang, QiaoDong; Liu, XiaoMing; Chen, JinSheng; Bao, CunJu; Liu, DongYang; Fang, ZeZang; Liang, XiaoYu; Lu, ZhenHe; Wan, Li

    2016-01-01

    Trigeminal neuralgia (TN) is a pain appearing in the ophthalmic (V1), maxillary (V2), and mandibular (V3) trigeminal branches. Pharmacologic treatment is the first line for TN; however, many patients prefer to receive minimally invasive treatment rather than medicine because of intolerable side effects. Thermocoagulation radiofrequency (TRF) is a minimally invasive treatment that has been shown to effectively treat the maxillary (V2) and mandibular (V3) divisions, but the safety of TRF treatment of the ophthalmic (V1) division has been controversial. This study was to observe the effectiveness and safety of TRF treatment of the ophthalmic (V1) division of trigeminal branches in idiopathic TN patients. An observational study. All of patients received temperature controlled TRF, the effectiveness and safety of TRF was assessed by VAS and complications. Eighty patients with ophthalmic division (V1) or ophthalmic division (V1) combined with maxillary (V2) or mandibular (V3) divisions of idiopathic TN were treated with step-increased temperature TRF for 6 minutes. At a pulse width of 20 ms, the temperature was titrated up 2 degrees from 60 degrees to 66 degrees every 60 seconds, and then another 66 degrees or 68 degrees for 2 minutes. Meanwhile, the tip of the cannula was turned 180 degrees with each temperature titration. Patients were assessed for pain relief and corneal reflex, numbness, and masticatory muscle weakness at one week, one month, and 3 months after the procedure. Eighty patients were successfully treated with temperature controlled TRF for ophthalmic (V1) division. Excellent pain relief was achieved in 79 of 80 patients (98.75%) after one week, one month, and 3 months, and 78 of 80 patients (97.5%) patients experienced tolerable numbness. Only one patient lost the corneal reflex, 14 experienced a corneal reflex that was mildly decreased, and 2 patients felt a foreign body sensation in the ipsilateral eye after TRF, but there were no corneal ulcers

  17. 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

  18. Perceived colleagues' safety knowledge/behavior and safety performance: safety climate as a moderator in a multilevel study.

    PubMed

    Jiang, Li; Yu, Guangtao; Li, Yongjuan; Li, Feng

    2010-09-01

    This study presented a model specifying the relationship of unit-level safety climate and perceived colleagues' safety knowledge/behavior (PCSK/B) to safety behavior (safety compliance and safety participation), as well as safety performance (injuries and near misses). PCSK/B, a measure of descriptive norms, was taken as a new individual-level predictor. Hierarchical linear modeling analyses indicated the significant cross-level interaction effects of unit-level safety climate and PCSK/B on safety behavior, i.e., the more positive the safety climate, the stronger effects PCSK/B has on safety behavior. The effect of PCSK/B on injuries was mediated by safety behavior. Implications for management and safety climate research were discussed. 2009 Elsevier Ltd. All rights reserved.

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

    PubMed

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

    2016-01-01

    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. 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, χ(2) test, or Fisher's exact test as appropriate. As supportive analysis, a logistic regression model was estimated to evaluate associations between gender and outcome. 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, χ(2) 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, χ(2)P=0.0039). Slightly significantly more AEs in females were addressed with treatment compared with males (78.1% vs 66.7%, χ(2)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 (χ(2) test P=0.0246). 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 from a gender-specific perspective.

  20. 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

  1. A Multicenter, Randomized, Observer-blinded, Active-controlled Study Evaluating the Safety and Effectiveness of Ceftaroline Compared With Ceftriaxone Plus Vancomycin in Pediatric Patients With Complicated Community-acquired Bacterial Pneumonia.

    PubMed

    Blumer, Jeffrey L; Ghonghadze, Tina; Cannavino, Christopher; O'Neal, Tanya; Jandourek, Alena; Friedland, Hillel David; Bradley, John S

    2016-07-01

    The broad-spectrum cephalosporin ceftaroline, a metabolite of the prodrug ceftaroline fosamil, has shown in vitro activity against clinical isolates from pediatric patients. This multicenter, randomized, observer-blinded, active-controlled study (NCT01669980) assessed the safety and effectiveness of ceftaroline fosamil compared with ceftriaxone plus vancomycin in patients between 2 months and 17 years of age with complicated community-acquired bacterial pneumonia. Patients were randomized 3:1 (stratified by age cohort) to receive either ceftaroline fosamil or ceftriaxone plus vancomycin (comparator) as intravenous therapy for ≥3 days. Patients who met specific study criteria on or after Study Day 4 were permitted to switch to an oral study drug. Safety assessments were treatment-emergent adverse events, and the effectiveness of treatment was assessed by clinical and microbiologic outcomes. The median duration of intravenous treatment was 9.0 (range, 3.0-19.0) days in the ceftaroline fosamil group (N=30) and 7.5 (5.0-13.0) days in the comparator group (N=10). At least one treatment-emergent adverse event was experienced by 12/30 patients (40%) in the ceftaroline fosamil group and 8/10 (80%) in the comparator group; most treatment-emergent adverse events in both groups were mild to moderate in intensity. Clinical response rates in the modified intent-to-treat population were 52% (15/29 patients) in the ceftaroline fosamil group and 67% in the comparator group (6/9); clinical stability at Study Day 4 was 21% (6/29) and 22% (2/9), respectively. Ceftaroline fosamil was well tolerated and showed similar clinical response rates to ceftriaxone plus vancomycin in pediatric patients with complicated community-acquired bacterial pneumonia.

  2. Safety of rituximab in the routine treatment of rheumatoid arthritis in Italy in patients refractory to anti-TNFa drugs: results from the observational retrospective-prospective RUBINO study.

    PubMed

    Bazzichi, L; Biasi, D; Tinazzi, E; Muratore, M; Pellerito, R; Russo, R; Corsaro Santi, M; De Sandre, P; Epis, O; Granata, M; Kroegler, B; Meschini, C; Versace, F; Astolfi, C

    2014-11-06

    The paper reports the results from the observational retrospective-prospective RUBINO study conducted in Italy to assess the safety of rituximab in the treatment of rheumatoid arthritis (RA) in routine clinical practice. The percentage of patients who manifested at least one grade 3 or 4 adverse event (AE) assessed by the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v.3) during the observation period (primary objective) was evaluated. The percentage of patients manifesting a severe AE (SAE), clinical response to rituximab treatment, clinical remission according to disease activity score for 28 joints (DAS28) criteria, markers of disease and quality of life were also assessed. Fifty-three Italian rheumatology centers took part in the study. Patients with a diagnosis of RA and inadequate response to anti-tumor necrosis factor b (anti-TNFa) drugs were enrolled. Participating patients had previously received at least one cycle of rituximab, and treatment was still ongoing at the time of recruitment. Out of 205 patients enrolled, 60% manifested no form of AE, 14.2% had at least one grade 3 or 4 AE, and 11.2% patients reported an SAE. The overall percentage of patients manifesting AEs (40%) was lower compared to the DANCER (81% and 85%), REFLEX (85%) and RESET (85% and 69%) studies, but higher than that observed in the CERERRA registry (from 10.2% to 13.9%). This difference may be due to the shorter observation period applied in the CERERRA registry (only 12 months) compared to the RUBINO study (up to 3 years). All parameters of RA activity (erythrocyte sedimentation rate, C-reactive protein, health assessment questionnaire score, DAS28) improved significantly during the study.

  3. 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).

  4. 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.

  5. Efficacy and safety profile of boceprevir- or telaprevir-based triple therapy or dual peginterferon alfa-2a or alfa-2b plus ribavirin therapy in chronic hepatitis C: the real-world PegBase observational study

    PubMed Central

    Mangia, Alessandra; Foster, Graham R.; Berg, Christoph P.; Curescu, Manuela; Ledinghen, Victor De; Habersetzer, François; Manolakopoulos, Spilios; Negri, Elisa; Papatheodoridis, George; Ahlers, Silke; Castillo, Marco; Bakalos, Georgios; Mauss, Stefan

    2017-01-01

    Background The aim of the study was to determine the efficacy and safety of triple therapy with a first-generation protease inhibitor (PI; boceprevir, telaprevir) plus peginterferon alfa-2a or -2b plus ribavirin, and dual therapy (peginterferon alfa-2a or -2b plus ribavirin) in patients with chronic hepatitis C (CHC) in routine clinical practice. Methods PegBase was an international, prospective, observational study in which 4441 patients with CHC were enrolled in 27 countries. This analysis focuses on results in 4100 treatment-naïve and previously treated patients treated with PI-based triple therapy or dual therapy, according to the discretion of the investigator and local standards of practice. The primary efficacy outcome was sustained virological response after 12-week follow up (SVR12). Results SVR12 rates in treatment-naïve genotype (G) 1 patients were 56.6% and 62.9% for recipients of boceprevir plus peginterferon alfa-2a/ribavirin and boceprevir plus peginterferon alfa-2b/ribavirin, respectively, and 65.3% and 58.6% for recipients of telaprevir plus peginterferon alfa-2a/ribavirin and telaprevir plus peginterferon alfa-2b/ribavirin, respectively. In previously treated patients assigned to these four regimens, SVR12 rates were 43.6%, 48.3%, 60.3% and 56.1%, respectively. Among treatment-naïve patients assigned to peginterferon alfa-2a/ribavirin and peginterferon alfa-2b/ribavirin, respectively, SVR12 rates were 49.2% and 41.9% in G1 patients, 75.7% and 83.3% in G2 patients, 65.9% and 65.9% in G3 patients, and 49.7%, and 51.1% in G4 patients. The safety and tolerability of dual and triple therapy were consistent with previous reports. Conclusion The efficacy and safety of first-generation PI-based triple-therapy and dual-therapy regimens in this real-world cohort were broadly comparable to those of previous studies. PMID:28469364

  6. Efficacy and safety profile of boceprevir- or telaprevir-based triple therapy or dual peginterferon alfa-2a or alfa-2b plus ribavirin therapy in chronic hepatitis C: the real-world PegBase observational study.

    PubMed

    Mangia, Alessandra; Foster, Graham R; Berg, Christoph P; Curescu, Manuela; Ledinghen, Victor De; Habersetzer, François; Manolakopoulos, Spilios; Negri, Elisa; Papatheodoridis, George; Ahlers, Silke; Castillo, Marco; Bakalos, Georgios; Mauss, Stefan

    2017-01-01

    The aim of the study was to determine the efficacy and safety of triple therapy with a first-generation protease inhibitor (PI; boceprevir, telaprevir) plus peginterferon alfa-2a or -2b plus ribavirin, and dual therapy (peginterferon alfa-2a or -2b plus ribavirin) in patients with chronic hepatitis C (CHC) in routine clinical practice. PegBase was an international, prospective, observational study in which 4441 patients with CHC were enrolled in 27 countries. This analysis focuses on results in 4100 treatment-naïve and previously treated patients treated with PI-based triple therapy or dual therapy, according to the discretion of the investigator and local standards of practice. The primary efficacy outcome was sustained virological response after 12-week follow up (SVR12). SVR12 rates in treatment-naïve genotype (G) 1 patients were 56.6% and 62.9% for recipients of boceprevir plus peginterferon alfa-2a/ribavirin and boceprevir plus peginterferon alfa-2b/ribavirin, respectively, and 65.3% and 58.6% for recipients of telaprevir plus peginterferon alfa-2a/ribavirin and telaprevir plus peginterferon alfa-2b/ribavirin, respectively. In previously treated patients assigned to these four regimens, SVR12 rates were 43.6%, 48.3%, 60.3% and 56.1%, respectively. Among treatment-naïve patients assigned to peginterferon alfa-2a/ribavirin and peginterferon alfa-2b/ribavirin, respectively, SVR12 rates were 49.2% and 41.9% in G1 patients, 75.7% and 83.3% in G2 patients, 65.9% and 65.9% in G3 patients, and 49.7%, and 51.1% in G4 patients. The safety and tolerability of dual and triple therapy were consistent with previous reports. The efficacy and safety of first-generation PI-based triple-therapy and dual-therapy regimens in this real-world cohort were broadly comparable to those of previous studies.

  7. 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.

  8. 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

  9. 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

    Bateman, Alice G; Sheaff, Rod; Child, Susan; Boiko, Olga; Ukoumunne, Obioha C; Nokes, Tim; Copplestone, Adrian; Gericke, Christian A

    2013-06-04

    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. 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. 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). 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.

  10. Use of portable ladders - field observations and self-reported safety performance in the cable TV industry.

    PubMed

    Chang, Wen-Ruey; Huang, Yueng-Hsiang; Brunette, Christopher; Lee, Jin

    2017-11-01

    Portable ladders incidents remain a major cause of falls from heights. This study reported field observations of environments, work conditions and safety behaviour involving portable ladders and their correlations with self-reported safety performance. Seventy-five professional installers of a company in the cable and other pay TV industry were observed for 320 ladder usages at their worksites. The participants also filled out a questionnaire to measure self-reported safety performance. Proper setup on slippery surfaces, correct method for ladder inclination setup and ladder secured at the bottom had the lowest compliance with best practices and training guidelines. The observation compliance score was found to have significant correlation with straight ladder inclined angle (Pearson's r = 0.23, p < 0.0002) and employees' self-reported safety participation (r = 0.29, p < 0.01). The results provide a broad perspective on employees' safety compliance and identify areas for improving safety behaviours. Practitioner Summary: A checklist was used while observing professional installers of a cable company for portable ladder usage at their worksites. Items that had the lowest compliance with best practices and training guidelines were identified. The results provide a broad perspective on employees' safety compliance and identify areas for improving safety behaviours.

  11. 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.

  12. 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

  13. 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…

  14. Assessment of therapeutic efficacy and safety of artemether-lumefantrine (Coartem®) in the treatment of uncomplicated Plasmodium falciparum malaria patients in Bahir Dar district, Northwest Ethiopia: an observational cohort study.

    PubMed

    Ebstie, Yehenew A; Zeynudin, Ahmed; Belachew, Tefera; Desalegn, Zelalem; Suleman, Sultan

    2015-06-05

    Malaria is a complex disease, which varies in its epidemiology and clinical manifestation. Although artemether-lumefantrine has been used as first-line drug for uncomplicated Plasmodium falciparum malaria in Bahir Dar district since 2004, its efficacy has not yet been assessed. The main objective of this study was to quantify the proportion of patients with uncomplicated falciparum malaria who were prescribed artemether-lumefantrine and who failed treatment after a 28-day follow-up. The research team attempted to conduct an observational cohort study on the assessment of therapeutic efficacy and safety of artemether-lumefantrine in falciparum malaria patients aged over five years in Bahir Dar district from March to July 2012. Among 130 participants in the study, 60% were males with 1:5 male to female ratio. The mean of asexual parasitaemia load was 8675 parasites/μL and 96.1% participants were free from parasitaemia at day 3. At the end of the study, 98.5% of participants showed adequate clinical and parasitological response of the drug. In the study, only 1.5% of participants were shown late parasitological failure between seventh and 14th day follow-up and 1.3% of participants were free from anaemia at the end of follow-up. According to the research findings, artemether-lumefantrine fulfilled the inclusion criteria of WHO as first-line drug and continues to be the drug of choice for the treatment of uncomplicated falciparum malaria. Outputs from this study should be supported through advanced molecular techniques and blood concentration and pharmaco-vigilance of the drug.

  15. Railway safety climate: a study on organizational development.

    PubMed

    Cheng, Yung-Hsiang

    2017-09-07

    The safety climate of an organization is considered a leading indicator of potential risk for railway organizations. This study adopts the perceptual measurement-individual attribute approach to investigate the safety climate of a railway organization. The railway safety climate attributes are evaluated from the perspective of railway system staff. We identify four safety climate dimensions from exploratory factor analysis, namely safety communication, safety training, safety management and subjectively evaluated safety performance. Analytical results indicate that the safety climate differs at vertical and horizontal organizational levels. This study contributes to the literature by providing empirical evidence of the multilevel safety climate in a railway organization, presents possible causes of the differences under various cultural contexts and differentiates between safety climate scales for diverse workgroups within the railway organization. This information can be used to improve the safety sustainability of railway organizations and to conduct safety supervisions for the government.

  16. A phase IV observational multi-centre, open-label study on efficacy and safety of tolperisone 150 mg in patients with painful muscle spasm associated with degenerative or inflammatory diseases of the musculoskeletal system.

    PubMed

    Prabhoo, Ram; Keny, Swapnil; Prabhoo, Tanay; Singh, Amarinder; Rana, Rajiv

    2011-01-01

    To generate real world clinical data on efficacy and tolerability of tolperisone 150 mg in painful muscle spasms in Indian population. Prospective, open-labelled, non-comparative, multi-centre observational, Post Marketing surveillance study conducted at 174 participating orthopaedic care centres across India Nine hundred and twenty adult patients having painful muscle spasm associated with degenerative or inflammatory conditions were enrolled who received tolperisone 150 mg thrice daily orally for 7 days. Assessment of primary efficacy (muscle spasm) was done by (0-3) Likert scale. Adverse events were monitored for safety and global efficacy assessment was done by clinicians and patients at the end of study period. Significant improvements from baseline (p < 0.0001) in scores for muscle tone, mobility & pain were seen on days 3 & 7. At the end of study there was a significant reduction in scores by more than 80% from baseline. A subgroup analysis revealed no statistical difference in the scores in patients receiving Non-Steroidal AntiInflammatory Drug (NSAID) as compared to those receiving Tolperisone alone suggesting that Tolperisone alone could be offered to patients with painful muscle spasm who are intolerant to NSAIDs or in whom NSAIDs are contraindicated. Tolperisone was well tolerated with no sedation reported by any patient during study period. The incidence of common adverse effects like nausea, gastric irritation was less than 2%. Tolperisone is a safe, effective and non sedative alternative in management of acute painful spasm conditions associated with degenerative or inflammatory diseases of the musculoskeletal system. Key Messages: Tolperisone is a skeletal muscle relaxant without concomitant sedation or withdrawal phenomena. In this open-labelled, non-comparative, prospective study tolperisone was proved to be a safe & effective alternative to skeletal muscle relaxants in the management of acute painful spasm conditions associated with degenerative

  17. Safety and tolerability of Peg-grafeel(™), a pegfilgrastim, for the prophylactic treatment of chemotherapy-induced neutropenia and febrile neutropenia: A prospective, observational, postmarketing surveillance study in India.

    PubMed

    Talwar, Vineet; Nirni, Sharanabasappa S; Mallavarapu, Krishna Mohan; Ramkumar, Anupama; Sinha, Nitu

    2017-01-01

    A granulocyte colony-stimulating factor, pegfilgrastim, is efficacious though expensive for prophylactic treatment of chemotherapy-induced neutropenia and febrile neutropenia. Biologics available and accessible today, having acceptable safety-efficacy profiles, require postapproval studies for better understanding of such drugs in clinical settings. This postmarketing surveillance study evaluated the safety of prophylactic Peg-grafeel(™) (pegfilgrastim) in cancer patients with chemotherapy-induced neutropenia. This prospective, noninterventional, single-arm, open-label study was conducted at 10 study sites in India. Patients received subcutaneous 6 mg Peg-grafeel(™) approximately 24 h following chemotherapy as part of routine patient care. Data were summarized descriptively. The study included 250 patients (male: female = 36.4%:63.6%; median age, 54 [16-80] years). Most patients had Stage III (33.2%) or IV (41.6%) cancers and received cyclophosphamide (37.2%) and doxorubicin (31.6%) as chemotherapy. On an average, 4 Peg-grafeel(™) doses were administered per patient. Treatment-emergent adverse events (AEs) were reported in 115 (46%) patients, the most common being vomiting (11.6%), pain (11.2%), nausea (8.4%), and constipation (8.4%). Peg-grafeel(™)-related AEs included pain (3.2%), asthenia (2.4%), and arthralgia (1.2%). Bone pain (0.4%) and extremity pain (1.2%) were rare. Grade 3/4 neutropenia and febrile neutropenia occurred in 4 (1.6%) and 3 (1.2%) patients, respectively. Serious AEs included vomiting (2.8%) and pyrexia (2%). No new safety concerns were identified. None of the five deaths was considered related to Peg-grafeel(™). The overall safety profile of Peg-grafeel(™) was consistent with the expected safety profile of pegfilgrastim in patients with advanced malignancies in a clinical setting.

  18. Safety of live vaccinations on immunosuppressive therapy in patients with immune-mediated inflammatory diseases, solid organ transplantation or after bone-marrow transplantation - A systematic review of randomized trials, observational studies and case reports.

    PubMed

    Croce, Evelina; Hatz, Christoph; Jonker, Emile F; Visser, L G; Jaeger, Veronika K; Bühler, Silja

    2017-03-01

    Live vaccines are generally contraindicated on immunosuppressive therapy due to safety concerns. However, data are limited to corroborate this practice. To estimate the safety of live vaccinations in patients with immune-mediated inflammatory diseases (IMID) or solid organ transplantation (SOT) on immunosuppressive treatment and in patients after bone-marrow transplantation (BMT). A search was conducted in electronic databases (Cochrane, Pubmed, Embase) and additional literature was identified by targeted searches. Randomized trials, observational studies and case reports. Patients with IMID or SOT on immunosuppressive treatment and BMT patients <2years after transplantation. Live vaccinations: mumps, measles, rubella (MMR), yellow fever (YF), varicella vaccine (VV), herpes zoster (HZ), oral typhoid, oral polio, rotavirus, Bacillus Calmette-Guérin (BCG), smallpox. One author performed the data extraction using predefined data fields. It was cross-checked by two other authors. 7305 articles were identified and 64 articles were included: 40 on IMID, 16 on SOT and 8 on BMT patients. In most studies, the administration of live vaccines was safe. However, some serious vaccine-related adverse events occurred. 32 participants developed an infection with the vaccine strain; in most cases the infection was mild. However, in two patients fatal infections were reported: a patient with RA/SLE overlap who started MTX/dexamethasone treatment four days after the YFV developed a yellow fever vaccine-associated viscerotropic disease (YEL-AVD) and died. The particular vaccine lot was found to be associated with a more than 20 times risk of YEL-AVD. One infant whose mother was under infliximab treatment during pregnancy received the BCG vaccine at the age of three months and developed disseminated BCG infection and died. An immunogenicity assessment was performed in 43 studies. In most cases the patients developed satisfactory seroprotection rates. In the IMID group, YFV and VV

  19. Evaluation of the efficacy and safety of dual antiplatelet therapy with or without warfarin in patients with a clinical indication for DAPT and chronic anticoagulation: A meta-analysis of observational studies.

    PubMed

    Bavishi, Chirag; Koulova, Anna; Bangalore, Sripal; Sawant, Ashwin; Chatterjee, Saurav; Ather, Sameer; Valencia, Jose; Sarafoff, Nikolaus; Rubboli, Andrea; Airaksinen, Juhani K; Lip, Gregory Y H; Tamis-Holland, Jacqueline E

    2016-07-01

    To compare the efficacy and safety of dual antiplatelet therapy (DAPT) and triple therapy (TT, dual antiplatelet plus warfarin) in patients with myocardial infarction (MI) or PCI with stenting (PCI-S) who also require chronic oral anticoagulation. Recommendations for the optimal antiplatelet/anticoagulant treatment regimen for patients undergoing PCI-S or MI who also require oral anticoagulation are largely based on evidence from observational studies and expert opinions. A systematic search was performed for studies comparing TT vs. DAPT in patients post PCI-S or MI and requiring chronic anticoagulation. Primary outcome was all-cause mortality. Secondary outcomes were ischemic stroke, major bleeding, MI, and stent thrombosis. Pooled relative risks (RR) were calculated using random effects model. A total of 17 studies were included, with 14,921 patients [TT: 5,819(39%) and DAPT: 9,102(61%)] and a mean follow-up of 1.6 years. The majority of patients required oral anticoagulation for atrial fibrillation. Compared to DAPT, patients treated with TT had no significant difference in all-cause mortality [RR: 0.81, 95% confidence interval (CI): 0.61-1.08, P = 0.15], MI [RR 0.74, 95% CI: 0.51-1.06, P = 0.10], and stent thrombosis [RR 0.67, 95% CI: 0.35-1.30, P = 0.24]. Patients treated with TT had significantly increased risk of major bleeding [RR 1.20, 95% CI: 1.03-1.39, P = 0.02], whereas the risk for ischemic stroke was significantly lower [RR 0.59, 95% CI: 0.38-0.92, P = 0.02]. All-cause mortality appears similar in patients treated with TT or DAPT although TT was associated with higher rates of major bleeding and a lower risk for ischemic stroke. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

  20. 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.

  1. 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

  2. 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.

  3. 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

  4. 76 FR 3908 - Safety and Occupational Health Study Section (SOHSS); National Institute for Occupational Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-21

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

  5. Three studies testing the effects of role models on product users' safety behavior.

    PubMed

    deTurck, M A; Chih, I H; Hsu, Y P

    1999-09-01

    Three studies were conducted to determine the effect of a role model's safety behavior on observers' safety behavior. In Studies 1 and 2, role models (confederates) used a cleaning product requiring them to wear safety gloves. Study 1 examined observers' safety behavior after they witnessed a friendly (unfriendly) role model's safety behavior in one of four conditions: 1) wearing rubber gloves, 2) not wearing rubber gloves and experiencing no chemical burn, 3) not wearing rubber gloves and experiencing a mild chemical burn, and 4) not wearing rubber gloves and experiencing a severe chemical burn. In Study 2, participants tested a cleaning product with a warning message (low hazard vs. high hazard) after observing a role model first test the cleaning product in one of the four conditions specified above. As predicted, in Studies 1 and 2, observers were influenced by the role model's safety behavior. However, the friendliness of the role model (Study 1) and level of hazard (Study 2) communicated in the warning message did not influence participants' safety behavior. Using an over-the-counter pain reliever, Study 3 tested the joint effects of: 1) the level of hazard communicated in the warning, 2) observers' outcome-relevant involvement, and 3) role model's compliance. Although the level of hazard communicated in the warning exerted no impact on observers' safety compliance, the role model's safety behavior and level of involvement jointly influenced observers' safety behavior. The implications of the findings and future research directions are discussed. Actual or potential applications of the research include, but are not limited to, using role models in warning messages and safety training programs to demonstrate the proper use of safety gear so as to enhance product users' compliance with safety recommendations.

  6. 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.

  7. The effect of safety initiatives on safety performance: a longitudinal study.

    PubMed

    Hoonakker, Peter; Loushine, Todd; Carayon, Pascale; Kallman, James; Kapp, Andrew; Smith, Michael J

    2005-07-01

    Construction industry is one of the most dangerous industries, not only in the USA, but worldwide. In this longitudinal study we examined the effects of safety initiatives on the safety performance of construction companies. One of the measures commonly used in the USA to track a company's safety performance is the experience modification rate (EMR). The EMR is based on the company's safety records (injury claims) from the past three full years and is used to calculate the workers' compensation insurance premiums. In a longitudinal study, we studied the effects of safety efforts and initiatives on the EMR. The results show that safety initiatives and money spent on safety do improve safety performance, but only over time.

  8. Efficacy and safety of losartan 100 mg or losartan 100 mg plus hydrochlorothiazide 25 mg in the treatment of patients with essential arterial hypertension and CV risk factors: observational, prospective study in primary care.

    PubMed

    Bönner, G; Smolka, W; Jung, C; Bestehorn, K

    2009-04-01

    Patients with high cardiovascular risk are prevalent in ambulatory care. To achieve adequate blood pressure control, such patients require higher drug doses and/or combination therapy. We aimed to assess the efficacy and safety of losartan 100 mg as monotherapy or in fixed-dose combination with hydrochlorothiazide 25 mg. Multicentre, prospective, open observational study over 13 weeks in patients with essential hypertension, whose blood pressure was not adequately controlled despite pretreatment. Main outcome parameters were the systolic (SBP) and diastolic (DBP) blood pressure reduction, the rate of normalized patients at study end compared to baseline, and the number and type of adverse events (AEs). Of the 7702 documented patients, 53.1% (N = 4088) were men, with a mean age of 63.5 +/- 10.7 years. Comorbidities were frequent (diabetes mellitus in 57.4% [N = 4418], coronary heart disease in 30.3% [N = 2330], left ventricular hypertrophy in 28.2% [N = 2172], heart failure in 14.0% [N = 1079], and peripheral arterial disease in 9.0% [N = 690]). Patients received losartan 100 mg in 45.7% (N = 3521), losartan/HCTZ in 53.8% (N = 4143); additional antihypertensive drugs were given in 45.5% (N = 3505). Physicians reported somewhat lower target values than those stipulated by the guidelines (irrespective of age, gender, and concomitant diseases except for diabetes). Mean SBP/DBP decreased from a baseline value of 158/93 mmHg by 24/12 mmHg at study end. The BP lowering effect was similar in subgroups by treatment or comorbidity, respectively, however target attainment rates were substantially higher in non-diabetic patients. Metabolic and renal parameters (fasting glucose, HbA(1c), serum creatinine and albumin in urine) showed trends for improvement. Tolerability was very good, as only 0.43% (N = 33) experienced an AE (in 0.31% [N = 24] serious AEs), and 0.08% (N = 6) discontinued therapy due to reasons related to study drug. In high-risk patients, treatment with losartan

  9. 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.

  10. Health and safety in organic farming: a qualitative study.

    PubMed

    Soto Mas, Francisco; Handal, Alexis J; Rohrer, Rose E; Tomalá Viteri, Eric

    2017-09-22

    To explore health and safety issues in organic farming, specifically among small farmers in central New Mexico. Participants included 10 certified organic producers and 20 workers. Data were collected through semi-structured interviews and observations. The sample consisted of a young, educated, low experienced population which may differ from conventional farmers. Both producers and workers seemed to be aware of the health risks involved with small-scale farming. Producers presented mixed attitudes towards health and safety, while workers' attitudes were more systematically negative. Perception of risk was generally lower among workers compared to producers. Although health and safety training was not specifically mentioned, most participants seemed to understand the relevance of the work environment for health and safety. Regarding ergonomics, the physical demands of working long hours and having to perform a multitude of tasks that contribute to physical stress were issues of concern. This is one of few studies in the United States exploring health and safety among organic farmers. Although participants reported very few actual incidents, the study identified relevant intrapersonal and behavioral factors that may increase or reduce the risk for disease and injury. Results also point to the need for research that focuses on the psychosocial and contextual factors that may contribute to injury and disease among organic farmers.

  11. 75 FR 26266 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-11

    ... improvements in the delivery of occupational safety and health services, and the prevention of work-related... 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...

  12. 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

    ... improvements in the delivery of occupational safety and health services, and the prevention of work-related... 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...

  13. 78 FR 75922 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-13

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

  14. Safety of oral bisphosphonates: controlled studies on alveolar bone.

    PubMed

    Jeffcoat, Marjorie K

    2006-01-01

    Osteoporosis and osteopenia are characterized by reductions in bone mass and may lead to skeletal fragility and fracture. The latest generation of oral bisphosphonate drugs, including alendronate and risendronate, has been approved for the prevention and treatment of osteoporosis. These medications are chemically absorbed into bone, decreasing osteoclast number and activity and thereby decreasing bone resorption. The purpose of this report is to present safety data from 2 controlled studies in patients receiving oral bisphosphonates. Study 1 tested the effect of alendronate, an inhibitor of bone resorption, on alveolar bone. A total of 335 patients (162 men and 173 women, aged 30 to 79 years) with moderate or severe periodontal disease were randomized to either placebo or 70 mg alendronate once weekly. Alveolar bone height and safety were assessed over a 2-year period. Study 2 was a longitudinal single-blind controlled design comparing implant success in 50 consecutive patients (210 implants), 25 patients who received bisphosphonate therapy and 25 age-matched control subjects. Implant success and safety, including incidence of osteonecrosis of the jaws (ONJ), was blindly assessed for at least 3 years. In study 1, no cases of ONJ were observed in either treatment group. Furthermore, a trend toward lower incidences of infection and tooth loss was observed in the alendronate group. In study 2, no cases of ONJ were observed in either group, and implant success was greater than 99% in both groups. On the basis of 2 controlled clinical studies, oral bisphosphonate usage was not associated with occurrence of ONJ.

  15. Determination of motor threshold using visual observation overestimates transcranial magnetic stimulation dosage: Safety implications

    PubMed Central

    Lisanby, Sarah H.; Luber, Bruce

    2014-01-01

    Objective While the standard has been to define motor threshold (MT) using EMG to measure motor cortex response to transcranial magnetic stimulation (TMS), another method of determining MT using visual observation of muscle twitch (OM-MT) has emerged in clinical and research use. We compared these two methods for determining MT. Methods Left motor cortex MTs were found in 20 healthy subjects. Employing the commonly-used relative frequency procedure and beginning from a clearly suprathreshold intensity, two raters used motor evoked potentials and finger movements respectively to determine EMG-MT and OM-MT. Results OM-MT was 11.3% higher than EMG-MT (p<0.001), ranging from 0-27.8%. In eight subjects, OM-MT was more than 10% higher than EMG-MT, with two greater than 25%. Conclusions These findings suggest using OM yields significantly higher MTs than EMG, and may lead to unsafe TMS in some individuals. In more than half of the subjects in the present study, use of their OM-MT for typical rTMS treatment of depression would have resulted in stimulation beyond safety limits. Significance For applications that involve stimulation near established safety limits and in the presence of factors that could elevate risk such as concomitant medications, EMG-MT is advisable, given that safety guidelines for TMS parameters were based on EMG-MT. PMID:23993680

  16. Improving safety culture through the health and safety organization: a case study.

    PubMed

    Nielsen, Kent J

    2014-02-01

    International research indicates that internal health and safety organizations (HSO) and health and safety committees (HSC) do not have the intended impact on companies' safety performance. The aim of this case study at an industrial plant was to test whether the HSO can improve company safety culture by creating more and better safety-related interactions both within the HSO and between HSO members and the shop-floor. A quasi-experimental single case study design based on action research with both quantitative and qualitative measures was used. Based on baseline mapping of safety culture and the efficiency of the HSO three developmental processes were started aimed at the HSC, the whole HSO, and the safety representatives, respectively. Results at follow-up indicated a marked improvement in HSO performance, interaction patterns concerning safety, safety culture indicators, and a changed trend in injury rates. These improvements are interpreted as cultural change because an organizational double-loop learning process leading to modification of the basic assumptions could be identified. The study provides evidence that the HSO can improve company safety culture by focusing on safety-related interactions. © 2013. Published by Elsevier Ltd and National Safety Council.

  17. Attitude is everything? The impact of workload, safety climate, and safety tools on medical errors: a study of intensive care units.

    PubMed

    Steyrer, Johannes; Schiffinger, Michael; Huber, Clemens; Valentin, Andreas; Strunk, Guido

    2013-01-01

    Hospitals face an increasing pressure toward efficiency and cost reduction while ensuring patient safety. This warrants a closer examination of the trade-off between production and protection posited in the literature for a high-risk hospital setting (intensive care). On the basis of extant literature and concepts on both safety management and organizational/safety culture, this study investigates to which extent production pressure (i.e., increased staff workload and capacity utilization) and safety culture (consisting of safety climate among staff and safety tools implemented by management) influence the occurrence of medical errors and if/how safety climate and safety tools interact. A prospective, observational, 48-hour cross-sectional study was conducted in 57 intensive care units. The dependent variable is the incidence of errors affecting those 378 patients treated throughout the entire observation period. Capacity utilization and workload were measured by indicators such as unit occupancy, nurse-to-patient/physician-to-patient ratios, levels of care, or NEMS scores. The safety tools considered include Critical Incidence Reporting Systems, audits, training, mission statements, SOPs/checklists, and the use of barcodes. Safety climate was assessed using a psychometrically validated four-dimensional questionnaire.Linear regression was employed to identify the effects of the predictor variables on error rate as well as interaction effects between safety tools and safety climate. Higher workload has a detrimental effect on safety, whereas safety climate-unlike the examined safety tools-has a virtually equal opposite effect. Correlations between safety tools and safety climate as well as their interaction effects on error rate are mostly nonsignificant. Increased workload and capacity utilization increase the occurrence of medical error, an effect that can be offset by a positive safety climate but not by formally implemented safety procedures and policies.

  18. Prospective Observational Post-marketing Study of Tafluprost 0.0015%/Timolol 0.5% Combination Ophthalmic Solution for Glaucoma and Ocular Hypertension: Short-Term Efficacy and Safety.

    PubMed

    Takagi, Yasutaka; Osaki, Hirotaka; Yamashita, Tomohiro; Kai, Yasuhiko

    2016-12-01

    The intraocular pressure (IOP)-lowering effect and safety of tafluprost 0.0015%/timolol maleate 0.5% combination ophthalmic solution (Taf-TFC) were investigated in a real-world clinical setting. A prospective up to 2-year (more than 1 year) observational study has been initiated to collect data on the IOP, conjunctival hyperemia score, corneal staining score, and adverse events suffered by patients with glaucoma or ocular hypertension treated at 3 months, and up to 2 years (more than 1 year) after initiating treatment with Taf-TFC. The 3-month findings are reported here. Among 439 patients enrolled at 100 institutions in Japan, most had normal tension glaucoma (45.3%) or primary open angle glaucoma (36.0%). Adverse drug reaction (ADR) occurred in 5.01%. The important ADRs were conjunctival hyperemia (five patients), blepharitis (four patients), and punctate keratitis (two patients). Serious adverse reactions occurred in two patients (three events). In 410 patients with data both before and after treatment, baseline mean IOP was 17.5 ± 5.0 mmHg, and it was significantly decreased after 1, 2, and 3 months (all P < 0.05, paired-t test). IOP was significantly reduced in patients switched to Taf-TFC from either prostaglandin or β-blocker monotherapy. IOP also decreased significantly in patients switched from a prostaglandin/timolol fixed combination, but not in patients switched from concomitant use of a prostaglandin analog and a β-blocker. The use of Taf-TFC did not worsen the adherence in most patients. Taf-TFC significantly reduced the IOP in patients with glaucoma or ocular hypertension treated in daily clinical practice with controllable or recoverable ADRs in short period. Taf-TFC was effective regardless of treatment patterns, and particularly, Taf-TFC significantly reduced IOP in cases in which requiring the second line therapy as insufficient of monotherapy. Santen Pharmaceutical Co., Ltd., Osaka, Japan.

  19. Safety and tolerability of an intra-seasonal initiation of the SQ-standardised grass allergy immunotherapy tablet: a non-interventional observational study investigating the feasibility during routine administration.

    PubMed

    Schwab, Jan-Alexander; Wolf, Hendrik; Schnitker, Jörg; Wüstenberg, Eike

    2013-10-01

    For specific immunotherapy to pollen allergy, a pre-seasonal start of treatment is recommended by international guidelines. In a placebo-controlled clinical trial with adults, an intra-seasonal start of therapy with the SQ-standardised grass allergy immunotherapy tablet (AIT) was well-tolerated. The objective of our study was to investigate the feasibility of an intra-seasonal start of grass AIT administered during routine treatment by practising allergists. In a multicentre, prospective, open-label, uncontrolled, non-interventional observational study, data on routine treatment with grass AIT were recorded in patients who started administration of tablets within the 2010 grass pollen season in Germany. Adverse events (AEs) were recorded by the physician at visits for the first administration in the clinic and at the end of the 1- to 3-month observation period. AEs and daily administration of the tablet were recorded by the patients in diaries for the first 14 days. Treatment satisfaction, global tolerability and perceived effect of treatment were assessed by the patient and physician at the end of the study. A total of 662 patients were treated with 1 tablet daily by 286 physicians. Grass AIT was started intra-seasonally in 620 patients and post-season in 42. The average treatment period was 51.6 days. AEs were recorded in 52.1 % of all patients and in 35.6 % at first administration, with throat irritation (21.3 %), paraesthesia oral (19.9 %), oral pruritus (14.0 %) and ear pruritus (10.3 %) being the most frequent AEs related to grass AIT. The intensity of the AEs was assessed as mild or moderate in 42.1 % of patients and severe in 8.0 %; AEs related to grass AIT were classified as serious in two patients. Grass AIT was discontinued due to AEs in 7.7 % of patients. Diaries were evaluable for 77.0 % of patients; the average rate of patients with AEs decreased continuously from 44.7 % (day 1) to 26.9 % (day 14) and the average daily rate of patients who forgot to

  20. 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

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

    PubMed

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

    2014-01-01

    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. 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. 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. 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.

  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. Immunogenicity and safety of a fully liquid aluminum phosphate adjuvanted Haemophilus influenzae type b PRP-CRM197-conjugate vaccine in healthy Japanese children: A phase III, randomized, observer-blind, multicenter, parallel-group study.

    PubMed

    Togashi, Takehiro; Mitsuya, Nodoka; Kogawara, Osamu; Sumino, Shuji; Takanami, Yohei; Sugizaki, Kayoko

    2016-08-31

    Broad use of monovalent Haemophilus influenzae type b (Hib) conjugate vaccines based on the capsular polysaccharide polyribosyl-ribitol phosphate (PRP), has significantly reduced invasive Hib disease burden in children worldwide, particularly in children aged <1year. In Japan, PRP conjugated to tetanus toxoid (PRP-T) vaccine has been widely used since the initiation of public funding programs followed by a routine vaccination designation in 2013. We compared the immunogenicity and safety of PRP conjugated to a non-toxic diphtheria toxin mutant (PRP-CRM197) vaccine with the PRP-T vaccine when administered subcutaneously to healthy Japanese children in a phase III study. Additionally, we evaluated the immunogenicity and safety profiles of a diphtheria-tetanus acellular pertussis (DTaP) combination vaccine when concomitantly administered with either PRP-CRM197 or PRP-T vaccines. The primary endpoint was the "long-term seroprotection rate", defined as the group proportion with anti-PRP antibody titers ⩾1.0μg/mL, after the primary series. Long-term seroprotection rates were 99.3% in the PRP-CRM197 group and 95.6% in the PRP-T group. The intergroup difference (PRP-CRM197 group - PRP-T group) was 3.7% (95% confidence interval: 0.099-7.336), demonstrating that PRP-CRM197 vaccine was non-inferior to PRP-T vaccine (p<0.0001). Furthermore, the "short-term seroprotection rate" (anti-PRP antibody titer ⩾0.15μg/mL) before booster vaccination was higher in the PRP-CRM197 group than in PRP-T. Concomitant administration of PRP-CRM197 vaccine with DTaP vaccine showed no differences in terms of immunogenicity compared with concomitant vaccination with PRP-T vaccine and DTaP vaccine. Although CRM197 vaccine had higher local reactogenicity, overall, both Hib vaccines had acceptable safety and tolerability profiles. The immunogenicity of PRP-CRM197 vaccine administered subcutaneously as a three-dose primary series in children followed by a booster vaccination 1year after the

  4. A study of assessment of patient safety climate in tertiary care hospitals.

    PubMed

    Chakravarty, Abhijit; Sahu, Anupam; Biswas, Manash; Chatterjee, Kaustuv; Rath, Subrata

    2015-04-01

    Medical errors are being detected with increasing frequency in healthcare environment, in many cases leading to patient harm. Measurement and improvement of patient safety climate has been identified as a strategic effort towards addressing this vital issue. Safety Attitude Questionnaire (SAQ), validated by previous research was administered to 300 respondents in three tertiary care hospitals of India, the respondents representing various categories of healthcare workers and variations in safety scale score was analyzed by various statistical tools. No variation was observed in the Patient Safety Index score among the study hospitals. However, significant variations were observed among different categories of healthcare workers across dimensions of Teamwork, Perception of Management and Stress Recognition. Multiple Regression models identified Teamwork and Perception of Management to have significant correlation with Patient Safety Index Score. Patient Safety Climate can be effectively assessed and such assessment utilized for focused improvement efforts towards safety in healthcare organizations.

  5. 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.

  6. 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.

  7. Lithium sulfur dioxide battery safety studies

    NASA Astrophysics Data System (ADS)

    Venkatasetty, H.; Ebner, W. B.; Chua, D. L.; Barnes, J. A.; Bis, R. F.

    The effects of discharge parameters and storage on the safe operating limits of Li/SO2 batteries in fleet use were investigated using acceleration rate calorimetry and in situ spectroelectrochemistry to measure the parameters of thermal behavior, the chemistry, and the electrochemistry of Li/SO2 cells. Measurements were performed under the conditions of discharge at room temperature and at -20 C, storage at room temperature, and overdischarge at room temperature and at -20 C. It was found that partially discharged and stored Li/SO2 cells displayed no change in safety characteristics during subsequent use. However, upon forced overdischarge at -20 C, these cells produced a rapid and violent reaction. Spectroelectrochemical studies of electrolyte solutions from discharged cells disclosed no hazardous chemical species other than thionates, sulfate, and dithionite; the spectral analysis of gas samples from discharged and stored cells showed the formation of methane, ethane, ethylene, carbonyl sulfide, and carbon dioxide.

  8. Parents’ Perspectives on Safety in Neonatal Intensive Care: A Mixed-Methods Study

    PubMed Central

    Lyndon, Audrey; Jacobson, Carrie H.; Fagan, Kelly M.; Wisner, Kirsten; Franck, Linda S.

    2014-01-01

    Background & Objectives Little is known about how parents think about neonatal intensive care unit (NICU) safety. Due to their physiologic immaturity and small size, infants in NICUs are especially vulnerable to injury from their medical care. Campaigns are underway to integrate patients and family members into patient safety. This study aimed to describe how parents of infants in the NICU conceptualize patient safety and what kinds of concerns they have about safety. Methods This mixed-methods study employed questionnaires, interviews, and observation with parents of infant patients in an academic medical centre NICU. Measures included parent stress, family-centredness, and types of safety concerns. Results 46 parents completed questionnaires and 14 of these parents also participated in 10 interviews (including 4 couple interviews). Infants had a range of medical and surgical problems, including prematurity, congenital diaphragmatic hernia, and congenital cardiac disease. Parents were positive about their infants’ care and had low levels of concern about the safety of procedures. Parents reporting more stress had more concerns. We identified three overlapping domains in parent’s conceptualizations of safety in the NICU, including physical, developmental, and emotional safety. Parents demonstrated sophisticated understanding of how environmental, treatment, and personnel factors could potentially influence their infants’ developmental and emotional health. Conclusions Parents have safety concerns that cannot be addressed solely by reducing errors in the NICU. Parent engagement strategies that respect parents as partners in safety and address how clinical treatment articulates with physical, developmental, and emotional safety domains may result in safety improvements. PMID:24970266

  9. 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…

  10. 77 FR 4048 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-26

    ... safety and health services, and the prevention of work-related injury and illness. It is anticipated that... magnitude of the aggregate health burden associated with occupational injuries and illnesses, as well as to... HUMAN SERVICES Centers for Disease Control and Prevention Safety and Occupational Health Study Section...

  11. 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

    ... safety and health services, and the prevention of work-related injury and illness. It is anticipated that... magnitude of the aggregate health burden associated with occupational injuries and illnesses, as well as to... HUMAN SERVICES Centers for Disease Control and Prevention Safety and Occupational Health Study Section...

  12. 78 FR 24751 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-26

    ... safety and health services, and the prevention of work-related injury and illness. It is anticipated that... magnitude of the aggregate health burden associated with occupational injuries and illnesses, as well as to... HUMAN SERVICES Centers for Disease Control and Prevention Safety and Occupational Health Study Section...

  13. 78 FR 56235 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-12

    ... occupational safety and health services, and the prevention of work-related injury and illness. It is... the magnitude of the aggregate health burden associated with occupational injuries and illnesses, as... HUMAN SERVICES Centers for Disease Control and Prevention Safety and Occupational Health Study Section...

  14. 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(a)(2...

  15. 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 10(a)(2...

  16. 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…

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

    PubMed

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

    2010-03-01

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

  18. 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

  19. 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.

  20. 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…

  1. Adherence to Treatment, Safety, Tolerance, and Effectiveness of Perindopril/Amlodipine Fixed-Dose Combination in Greek Patients with Hypertension and Stable Coronary Artery Disease: A Pan-Hellenic Prospective Observational Study of Daily Clinical Practice.

    PubMed

    Liakos, Charalampos I; Papadopoulos, Dimitrios P; Kotsis, Vasilios T

    2017-05-02

    Initiation of antihypertensive therapy with a two-drug fixed-dose combination (FDC) in a single tablet may be recommended in patients at high risk of cardiovascular events to improve adherence and effectiveness. Preferred combinations include an angiotensin-converting enzyme inhibitor with a dihydropyridine calcium antagonist. This study assessed adherence to and the safety, tolerance, and effectiveness of the perindopril/amlodipine FDC in Greek patients with hypertension and stable coronary artery disease (CAD) over a 4-month period. A total of 1907 patients with hypertension and CAD (59.1% males) who had recently (≤2 weeks) commenced treatment with the perindopril/amlodipine FDC (5/5, 5/10, 10/5, or 10/10 mg) were studied at baseline and at 1 and 4 months. Adherence to treatment was assessed with the Morisky Medication-taking Adherence Scale (MMAS). Seven patients (0.4%) did not attend the scheduled visits. In total, 1607 (84.6%) patients received a constant treatment dose throughout the study. High adherence (MMAS score = 0) was reported by 1592 (83.6%), 1628 (85.7%), and 1477 (77.7%) patients at the second and the third visit and at both visits, respectively. Adverse reactions were reported by only 13 (0.7%) patients, were all minor, and did not result in treatment discontinuation. Office blood pressure (BP) was significantly decreased at the third visit (130.8 ± 8.4/78.2 ± 6.4 mmHg) compared with baseline (156.5 ± 15.0/89.9 ± 9.6 mmHg; p < 0.001), regardless of previous antihypertensive treatment. Patients with grade 1, 2, and 3 hypertension at baseline showed a reduction in BP of 19.3/9.4, 31.5/13.5, and 47.8/22.2 mmHg, respectively (p < 0.001). Uncontrolled hypertension (≥140/90 mmHg) was notably reduced from 90.3% at baseline to 18.5% at the third visit. The perindopril/amlodipine FDC is characterized by high adherence and effectiveness, regardless of previous treatment. Degree of BP reduction was related to baseline BP levels

  2. 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…

  3. 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.

  4. 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…

  5. 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.

  6. OBSERVE-5: Observational postmarketing safety surveillance registry of etanercept for the treatment of psoriasis final 5-year results

    PubMed Central

    Kimball, Alexa B.; Rothman, Kenneth J.; Kricorian, Gregory; Pariser, David; Yamauchi, Paul S.; Menter, Alan; Teller, Craig F.; Aras, Girish; Accortt, Neil A.; Hooper, Michele; Rice, Kara Creamer; Gelfand, Joel M.

    2016-01-01

    Background OBSERVE-5 was a 5-year FDA-mandated surveillance registry of psoriasis patients. Objective To assess long-term etanercept safety and effectiveness. Methods Patients with moderate to severe psoriasis enrolled; a single baseline dose of etanercept was required. Key outcome measures included serious adverse events (SAEs), serious infectious events (SIEs), events of medical interest, psoriasis-affected body surface area, physician global assessment, and Dermatology Life Quality Index. Safety outcomes were assessed relative to data from the MarketScan database. Results For 2,510 patients, 5-year cumulative incidence (95% confidence interval [CI]) was 22.2% (20.3%, 24.2%) for SAEs; 6.5% (5.4%, 7.7%) for SIEs; 3.2% (2.3%, 4.1%) for malignancies excluding nonmelanoma skin cancer (NMSC); 3.6% (2.7%, 4.5%) for NMSC; 2.8% (2.0%, 3.6%) for coronary artery disease; 0.7% (0.3%, 1.2%) for psoriasis worsening; 0.2% (0.0%, 0.4%) for CNS demyelinating disorder; 0.1% (0.0%, 0.3%) for lymphoma and for tuberculosis; 0.1% (0.0%, 0.2%) for opportunistic infection and for lupus; 55 fatal events were reported. Rates of malignancies, lymphomas, NMSC, and hospitalization-associated infections were not higher than expected relative to administrative claims data. The percentage of patients rated as clear/almost clear was 12% at baseline, which increased to 51% at month 6 and remained relatively stable throughout 5 years. Limitations No internal comparator group was included; rare events may not have been detected. Conclusion No new safety signals were observed with long-term, real-world etanercept use. PMID:25264239

  7. 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.

  8. 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)

  9. 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)

  10. 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…

  11. 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…

  12. 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…

  13. 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

  14. 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

  15. Comparison of self-reported and observed prevalence of safety belt and helmet use in Florence.

    PubMed

    Lorini, C; Pieralli, F; Mersi, A; Cecconi, R; Garofalo, G; Santini, M G; Bonaccorsi, G

    2014-01-01

    Safety belt and helmet use was estimated from PASSI data and measured through Ulisse observations. Between 2008 and 2012 a total of 2,081 cars and motorcycle users were interviewed in the LHU of Florence and a total of 59,787 drivers (11,870 front passengers, 1,129 rear passengers and 16,816 motorcyclists) were observed. The comparison between self-reported and observed prevalences was performed by calculating the over-reporting factor (ORF), defined as the ratio of the self-reported to the observed prevalence of seat belt or helmet use. The time trend of the prevalence (both from self-reported and observed data) and of the ORF was assessed by using linear regression and Poisson's regression, respectively. The correlation between self-reported and observed prevalence is high, with a Pearson's correlation coefficient of 0.95 (p <0.05). Regarding front seat belt use rates, the difference between self-reported and observed data increases over time and the ORF range varies from 1.12 to 1.32. Rear seat belt data show a great variability, and the ORF varies from 0.67 to 1.37. In 2011 and 2012, the observed prevalence was higher than the self-reported one (ORF <1). Helmet use rates are very high, close to 100% with both methods; ORF has very small oscillations and ranges from 0.98 to 1, showing a good correlation between self-reported and observational data. There are no significant temporal variations both for the prevalences of use and for the ORF. The reasonable accuracy of self-reported data makes this method fit in the routinary assessment of safety belts and helmet usage, in order to limit the observations of the Ulisse system at predetermined time intervals. However, self-reported estimates need to be adjusted using an appropriate over-reporting factor.

  16. Bacteriuria and safety of female urodynamic studies.

    PubMed

    Dass, Anil Krishna; Lo, Tsia-Shu; Khanuengkitkong, Siwatchaya; Tan, Yiap-Loong

    2013-04-01

    Our aim was to study the incidence of bacteriuria after urodynamic studies (UDS) and prevalence of asymptomatic bacteriuria before UDS. In this prospective study between March and September 2011, 140 women undergoing UDS were subjected to urine culture before the investigation. Urine was collected aseptically with a sterile catheter transurethrally. Multichannel UDS were performed 3-5 days after urine collection. Prophylactic antibiotics were not administered to these women. A second urine sample was collected within 5-7 days after UDS. Significant bacteriuria was defined as 10(2) colony-forming units (cfu)/ml or more of a single organism cultured. Thirty (21.4 %) women had asymptomatic bacteriuria before UDS and were excluded from the main study group. Among the 110 women in the study group, 4 (3.6 %) acquired infection after UDS. Three grew organisms found in the vagina (group B Streptococcus and yeast-like organism) and one grew Proteus mirabilis. Age 60 years and above is a significant risk factor. In contrast to the study group, among 30 women who had infection before UDS, Escherichia coli was the commonest pathogen in 19 (63.3 %) and 30 % had diabetes. Eleven (36.7 %) had persistent infection after UDS and the rest resolved spontaneously. In addition, no other related complication was observed on the UDS. This study shows that risk of post UDS bacteriuria is low in women and screening for vaginal infections may be necessary before UDS. Women over 60 years old are significantly at risk of infection. Bacteriuria is nevertheless mostly asymptomatic and transient in nature.

  17. 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.

  18. Feasibility and observed safety of interactive video games for physical rehabilitation in the intensive care unit: a case series.

    PubMed

    Kho, Michelle E; Damluji, Abdulla; Zanni, Jennifer M; Needham, Dale M

    2012-04-01

    Early rehabilitation in the intensive care unit (ICU) improves patients' physical function. Despite reports of using commercially available interactive video game systems for rehabilitation, there are few data evaluating feasibility and safety as part of routine in-patient rehabilitation, particularly in the ICU. We conducted an observational study from September 1, 2009, to August 31, 2010, of adults admitted to a 16-bed medical ICU receiving video games as part of routine physical therapy (PT), evaluating use and indications and occurrence of 14 prospectively monitored safety events. Of 410 patients receiving PT in the medical ICU, 22 (5% of all patients; male, 64%; median age, 52 years) had 42 PT treatments with video games (median [interquartile range] per patient, 1.0 [1.0-2.0]). Main indications for video game therapy included balance (52%) and endurance (45%), and the most common activities included boxing (38%), bowling (24%), and balance board (21%). Of 42 treatments, 69% occurred while standing and 45% while mechanically ventilated. During 35 hours of PT treatment, 0 safety events occurred (95% upper confidence limit for safety event rate, 8.4%). Novel use of interactive video games as part of routine PT in critically ill patients is feasible and appears safe in our case series. Video game therapy may complement existing rehabilitation techniques for ICU patients. Copyright © 2011 Elsevier Inc. All rights reserved.

  19. [Safety and effectiveness of testicular prosthesis implantation for testis loss: clinical observation of 18 cases].

    PubMed

    Chen, Hui-Xing; Ning, Ye; Cai, Zhi-Kang; Ping, Ping; Huang, Mei; Xu, Di-Ping; Bo, Jun-Jie; Huang, Yi-Ran; Wang, Zhong; Li, Zheng

    2012-04-01

    To investigate the effect and safety of the implantation of a new type of testicular prosthesis in the treatment of testis loss. We recruited for this study 18 patients with testis loss treated by testicular prosthesis implantation, including 10 cases of prostate cancer, 3 cases of anorchia, 2 case of orchiatrophy, 2 cases of hermaphroditism and 1 case of cryptorchidism. The prosthesis was a hollow silicone elastomer YH-G1 made in China, selected according to the volume of the scrotum and the size of the contralateral testis. Thirteen of the patients received testicular prosthesis implantation with orchiectomy, and the other 5 underwent the procedure 6 months later. The operation time of testicular prosthesis implantation was (22.6 +/- 4.6) min, ranging from 15 to 30 minutes. All the patients were discharged after 12 hours of postoperative observation, with a mean hospital stay of (1.3 +/- 0.4) days. A follow-up after 6 months revealed no complications in 17 cases. Rejection occurred in 1 case at 3 months after the implantation, ending in the removal of the prosthesis. Of the 17 successful cases, 15 were very satisfied with the size of the prosthesis, 14 with its weight, 12 with its comfortableness, and all with the appearance of the scrotum and the position of the prosthesis, while 5 found the implant too rigid. The implantation of the new home-made silicone elastomer testicular prosthesis YH-G1 was safe and effective for the treatment of testis loss, and could meet the esthetic and psychological requirements of the patient. But further observation is needed for its long-term complications and influence on the patient's quality of life.

  20. Rider errors and amusement ride safety: observation at three carnival midways.

    PubMed

    Woodcock, Kathryn

    2007-03-01

    Over 5000 ride-exposures were observed at three carnival midways, with 103 ride installations. Rider and operator behaviour was observed and compared with posted safety regulations. The observed errors were analysed and clustered qualitatively and quantitatively. Rider errors were seen in 1.4% of individual ride-exposures, and little operator interception was seen. Most errors of both riders and operators were mistakes rather than slips or lapses, and many were violations. Qualitative typology based on error context indicated that social goals, sensory enhancement or convenience goals made sense of most mistakes. The most common single behaviour observed contrary to posted rules was leaning out or extending limbs. Future interventions should consider whether ride features could guide or support riders in achieving their goals rather than obstructing or prohibiting specific behaviours.

  1. Parents' perspectives on safety in neonatal intensive care: a mixed-methods study.

    PubMed

    Lyndon, Audrey; Jacobson, Carrie H; Fagan, Kelly M; Wisner, Kirsten; Franck, Linda S

    2014-11-01

    Little is known about how parents think about neonatal intensive care unit (NICU) safety. Due to their physiologic immaturity and small size, infants in NICUs are especially vulnerable to injury from their medical care. Campaigns are underway to integrate patients and family members into patient safety. This study aimed to describe how parents of infants in the NICU conceptualise patient safety and what kinds of concerns they have about safety. This mixed-methods study employed questionnaires, interviews and observation with parents of infant patients in an academic medical centre NICU. Measures included parent stress, family-centredness and types of safety concerns. 46 parents completed questionnaires and 14 of these parents also participated in 10 interviews (including 4 couple interviews). Infants had a range of medical and surgical problems, including prematurity, congenital diaphragmatic hernia and congenital cardiac disease. Parents were positive about their infants' care and had low levels of concern about the safety of procedures. Parents reporting more stress had more concerns. We identified three overlapping domains in parents' conceptualisations of safety in the NICU, including physical, developmental and emotional safety. Parents demonstrated sophisticated understanding of how environmental, treatment and personnel factors could potentially influence their infants' developmental and emotional health. Parents have safety concerns that cannot be addressed solely by reducing errors in the NICU. Parent engagement strategies that respect parents as partners in safety and address how clinical treatment articulates with physical, developmental and emotional safety domains may result in safety improvements. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  2. Design study on safety protection system of JSFR

    SciTech Connect

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

    2012-07-01

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

  3. Improving patient safety culture in general practice: an interview study

    PubMed Central

    Verbakel, Natasha J; de Bont, Antoinette A; Verheij, Theo JM; Wagner, Cordula; Zwart, Dorien LM

    2015-01-01

    Background When improving patient safety a positive safety culture is key. As little is known about improving patient safety culture in primary care, this study examined whether administering a culture questionnaire with or without a complementary workshop could be used as an intervention for improving safety culture. Aim To gain insight into how two interventions affected patient safety culture in everyday practice. Design and setting After conducting a randomised control trial of two interventions, this was a qualitative study conducted in 30 general practices to aid interpretation of the previous quantitative findings. Method Interviews were conducted at practice locations (n = 27) with 24 GPs and 24 practice nurses. The theory of communities of practice — in particular, its concepts of a domain, a community, and a practice — was used to interpret the findings by examining which elements were or were not present in the participating practices. Results Communal awareness of the problem was only raised after getting together and discussing patient safety. The combination of a questionnaire and workshop enhanced the interaction of team members and nourished team feelings. This shared experience also helped them to understand and develop tools and language for daily practice. Conclusion In order for patient safety culture to improve, the safety culture questionnaire was more successful when accompanied by a practice workshop. Initial discussion and negotiation of shared goals during the workshop fuelled feelings of coherence and belonging to a community wishing to learn about enhancing patient safety. Team meetings and day-to-day interactions enhanced further liaison and sharing, making patient safety a common and conscious goal. PMID:26622035

  4. Safety of Outpatient Total Ankle Arthroplasty vs Traditional Inpatient Admission or Overnight Observation.

    PubMed

    Mulligan, Ryan P; Parekh, Selene G

    2017-08-01

    Total joint surgeons have successfully performed hip, knee, and shoulder arthroplasty procedures in the outpatient setting without compromising safety, satisfaction, or results. The purpose of this study was to evaluate outpatient total ankle arthroplasty (TAA) as compared with overnight or extended inpatient stay, with regard to 90-day medical and operative complications, reoperations, readmissions or emergency room visits, and pain control. The medical records of patients who underwent TAA with 1 fellowship-trained orthopedic foot and ankle surgeon were reviewed. Outcome measures included operative complications, adverse medical events, readmission or emergency room visit for any reason, or reoperation within 90 days following surgery; surgeon's office contact before first postoperative visit regarding pain or other issues; visual analog scale pain score at the first postoperative visit; and need for narcotic refill. Outcomes were assessed by admission status: outpatient, overnight observation, or inpatient admission. Standard statistical analysis was used, and P < .05 was considered significant. Eighty-one patients underwent TAA who met inclusion criteria, and 8 had a complication (10%). A significant difference in complication rate was seen among groups ( P = .01) but not rate of readmission or reoperation. Of 16 patients, 5 (31%) who were admitted for 2 or more nights following surgery had a complication, as opposed to 3 of 65 (5%) who were outpatient or admitted overnight ( P = .01). There were no differences in frequency of postoperative phone calls, narcotic refills, or visual analog scale pain scores at the first postoperative visit. There were no adverse medical events. With proper instruction, TAA was performed safely in the outpatient setting. As health care policy continues to evolve in the United States, safe and efficient practices will remain a priority. Level III, retrospective comparative study.

  5. 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.

  6. 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)

  7. 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)

  8. 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 ...

  9. [STUDY OF SAFETY OF PAROTITIS VACCINE].

    PubMed

    Ignatiev, G M; Kulak, M V; Otrashevskaya, E V; Bukin, E K; Nesterov, A A E; Gorbunov, M A; Mikheev, V N

    2015-01-01

    Monitoring of post-vaccinal complications in children immunized with a parotitis vaccine. Observation of 198 945 children, immunized with 16 lots of parotitis vaccine with Leningrad-3 strain (L-3), was carried out for 3 years. Paired samples of sera and saliva were obtained from children, in whom adverse events were registered for 42 days after vaccination. Titers of specific IgM and IgG were determined in blood sera. Analysis of nucleotide sequences of genes F, SH and NH of RNA of parotitis virus was carried out from samples of blood and saliva. Intensive parameter of vaccine-associated aseptic meningitis under the conditions of the experiments was 0 for 100 000 immunized. Frequency of occurrence of post-vaccinal parotitis was 0.06% from the number of vaccinated--18 cases of vaccine-associated parotitis were registered and laboratory confirmed. A significant difference in specific activity was detected for 3 lots of the vaccine, that were associated with cases of development of parotitis, relative to that of 13 lots of vaccine, development of parotitis was not registered after administration of those. The study carried out confirmed low neurovirulence of the parotitis vaccine with the L-3 strain of parotitis virus, as well as a low degree of its reactogenicity. A relatively high immunization dose of the used vaccine could be one of the reasons of development of post-vaccinal complications in part of the immunized children.

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

    PubMed

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

    2015-06-03

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

  11. 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.

  12. 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

    ... aggregate health burden associated with occupational injuries and illnesses, as well as to support more... health services, and the prevention of work-related injury and illness. It is anticipated that research... HUMAN SERVICES Centers for Disease Control and Prevention Safety and Occupational Health Study Section...

  13. 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

    ... aggregate health burden associated with occupational injuries and illnesses, as well as to support more... health services, and the prevention of work-related injury and illness. It is anticipated that research... HUMAN SERVICES Centers for Disease Control and Prevention Safety and Occupational Health Study Section...

  14. 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

    ... HUMAN SERVICES Centers for Disease Control and Prevention Safety and Occupational Health Study Section... the Federal Register.'' In this case, the agency is giving less than 15 days' notice due to the recent... Services, Centers for Disease Control and Prevention, from October 1-16, 2013. The Director, Management...

  15. Aerosol observations for climate studies

    NASA Technical Reports Server (NTRS)

    Mccormick, M. P.

    1985-01-01

    The Stratospheric Aerosol Measurement II and Stratospheric Aerosol and Gas Experiment satellite systems have provided to date more than five years and almost three years, respectively, of data on atmospheric aerosol profiles on a near-global scale. Studies with these unique data sets are developing a global aerosol climatology for the first time and have shown the existence and quantification of polar stratospheric clouds and tropical stratospheric cirrus. In addition, a tropospheric cirrus climatology is evolving. Since these two experiments were launched, a series of large volcanic eruptions have occurred which have greatly impacted the stratospheric aerosol loading. The aerosol layer produced by the eruption of El Chichon, for example, increased the 30 mb temperatures in the northern tropics by as much as 4 C for six months after the eruption. This paper describes in detail, from a climate perspective, the evolving aerosol and cloud climatologies as a function of space and time, and shows the stratospheric dynamics of volcanic injections and their enhancements on stratospheric optical depth and mass loading.

  16. 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.

  17. 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.

  18. Tissue Window in Stroke Thrombolysis study (TWIST): a safety study.

    PubMed

    Hill, Michael D; Kenney, Carol; Dzialowski, Imanuel; Boulanger, Jean-Martin; Demchuk, Andrew M; Barber, Philip A; Watson, Timothy W J; Weir, Nicolas U; Buchan, Alastair M

    2013-01-01

    Stroke thrombolysis is limited by the "last-seen well" principle, which defines stroke onset time. A significant minority of stroke patients (~15%) awake with their symptoms and are by definition ineligible for thrombolysis because they were "last-seen well" at the time they went to bed implying an interval that is most often greater than three hours. A single-centre prospective, safety study was designed to thrombolyse 20 subjects with stroke-on-awakening. Patients were eligible for inclusion if they were last seen well less than 12 hours previously, specifically including those who awoke from sleep with their stroke deficits. They had a baseline computed tomogram (CT) scan with an ASPECTS score greater than 5, no evidence of well-evolved infarction and a CT angiogram / Trans-cranial Doppler ultrasound study demonstrating an intracranial arterial occlusion. Patients fulfilled all other standard criteria for stroke thrombolysis. The primary outcome was safety defined by symptomatic ICH or death. Among 89 screened patients, 20 were treated with thrombolysis. Two patients (10%) died due to massive carotid territory stroke and two patients (10%) died of stroke complications. Two patients (10%) showed asymptomatic intracerebral hemorrhage (ICH) (petechial hemorrhage) and none symptomatic ICH. Reasons for exclusion were: (a) ASPECTS ≤ 5 (29); (b) well-evolved infarcts on CT (19); (c) historical mRS > 2 (17); (d) no demonstrable arterial occlusion or were too mild to warrant treatment (10). Patients who awake with their deficits can be safely treated with thrombolysis based upon a tissue window defined by NCCT and CTA/TCD.

  19. Observer Error when Measuring Safety-Related Behavior: Momentary Time Sampling versus Whole-Interval Recording

    ERIC Educational Resources Information Center

    Taylor, Matthew A.; Skourides, Andreas; Alvero, Alicia M.

    2012-01-01

    Interval recording procedures are used by persons who collect data through observation to estimate the cumulative occurrence and nonoccurrence of behavior/events. Although interval recording procedures can increase the efficiency of observational data collection, they can also induce error from the observer. In the present study, 50 observers were…

  20. 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

  1. 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.

  2. Safety Culture and Mortality after Acute Myocardial Infarction: A Study of Medicare Beneficiaries at 171 Hospitals.

    PubMed

    Shahian, David M; Liu, Xiu; Rossi, Laura P; Mort, Elizabeth A; Normand, Sharon-Lise T

    2017-10-09

    To investigate the association between hospital safety culture and 30-day risk-adjusted mortality for Medicare patients with acute myocardial infarction (AMI) in a large, diverse hospital cohort. The final analytic cohort consisted of 19,357 Medicare AMI discharges (MedPAR data) linked to 257 AHRQ Hospital Survey on Patient Safety Culture surveys from 171 hospitals between 2008 and 2013. Observational, cross-sectional study using hierarchical logistic models to estimate the association between hospital safety scores and 30-day risk-adjusted patient mortality. Odds ratios of 30-day, all-cause mortality, adjusting for patient covariates, hospital characteristics (size and teaching status), and several different types of safety culture scores (composite, average, and overall) were determined. No significant association was found between any measure of hospital safety culture and adjusted AMI mortality. In a large cross-sectional study from a diverse hospital cohort, AHRQ safety culture scores were not associated with AMI mortality. Our study adds to a growing body of investigations that have failed to conclusively demonstrate a safety culture-outcome association in health care, at least with widely used national survey instruments. © Health Research and Educational Trust.

  3. 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

  4. Canadian Consumer Food Safety Practices and Knowledge: Foodbook Study.

    PubMed

    Murray, Regan; Glass-Kaastra, Shiona; Gardhouse, Christine; Marshall, Barbara; Ciampa, Nadia; Franklin, Kristyn; Hurst, Matt; Thomas, M Kate; Nesbitt, Andrea

    2017-10-01

    Understanding consumers' food safety practices and knowledge supports food safety education for the prevention of foodborne illness. The objective of this study was to describe Canadian consumer food safety practices and knowledge. This study identifies demographic groups for targeted food safety education messaging and establishes a baseline measurement to assess the effectiveness of food safety interventions over time. Questions regarding consumer food safety practices and knowledge were included in a population-based telephone survey, Foodbook, conducted from November 2014 to March 2015. The results were analyzed nationally by age group and by gender. The results showed that approximately 90% of Canadians reported taking the recommended cleaning and separating precautions when handling raw meat to prevent foodborne illness. Only 29% of respondents reported using a food thermometer when cooking any meat, and even fewer (12%) reported using a food thermometer for small cuts of meat such as chicken pieces. The majority (>80%) of Canadians were aware of the foodborne illness risks related to chicken and hamburger, but fewer (<40%) were aware of the risks related to frozen chicken nuggets, alfalfa sprouts, soft unpasteurized cheese, and unpasteurized juices. Generally, men were less likely to follow cooking instructions on packaging and took fewer steps to prevent cross-contamination than women. The youngest (18 to 29 years) age group was less likely to take steps to avoid cross-contamination and was less aware of the risks associated with eating an undercooked hamburger. The oldest (60+ years) respondents were less likely to be aware of the risks associated with raw eggs, alfalfa sprouts, and unpasteurized juice than the middle (30 to 59 years) age group. As a priority, food safety education in Canada should focus on increasing people's awareness of high-risk foods, specifically foods for which the awareness of risk found in this study was low; targeting messaging

  5. 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

  6. [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.

  7. Safety of epidural administration of Osteogenic Protein-1 (OP-1/BMP-7): behavioral and macroscopic observation.

    PubMed

    Kawakami, Mamoru; Hashizume, Hiroshi; Matsumoto, Takuji; Enyo, Yoshio; Okada, Motohiro; Yoshida, Munehito; Chubinskaya, Susan

    2007-06-01

    To assess the safety of epidural administration of Osteogenic Protein-1 (OP-1). To examine if epidural administration of OP-1 or administration into the nucleus pulposus (NP) resulted in ectopic bone formation and/or pain-related behavior. OP-1 has the potential for treatment of degenerative disc disease. However, OP-1's safety, when it is applied into the epidural space or herniated nucleus pulposus, is not well established. Forty rats were divided into 5 groups. Sham group: Left L4 and L5 nerve roots were exposed. NP group: The NP obtained from the tail was relocated onto the exposed nerve roots. NP+OP group: The NP obtained from the tail and injected with 0.2 microg of OP-1 in 1 microL of 5% lactose-buffered solution was placed on the nerve roots. GS group: A gelatin sponge was applied on the nerve roots. GS+OP group: A gelatin sponge soaked with 0.2 microg of OP-1 in 1 microL of 5% lactose-buffered solution was placed onto the nerve roots. Motor function and reflex responses to mechanical noxious stimuli were measured in all rats up to 3 weeks after surgery. Three weeks after surgery, all rats were killed for analysis of ectopic bone formation and magnitude of neural compression. Motor paresis was not observed in any groups. Only rats in the NP group showed evidence of irreversible mechanical hyperalgesia after surgery. There were no differences in the mechanical stimuli response among all groups except the NP group. Macroscopic examination revealed no ectopic bone formation or differences in neural compression among the groups. OP-1 application in the epidural space is safe based on behavioral measures and macroscopic observation on ectopic bone formation at 21 days after surgery.

  8. 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.

  9. 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.

  10. Post-marketing surveillance of the safety profile of iodixanol in the outpatient CT setting: a prospective, multicenter, observational study of patient risk factors, adverse reactions and preventive measures in 9953 patients.

    PubMed

    Müller, F H H

    2014-11-01

    Non-interventional study in outpatient, contrast-enhanced CT; 1. to determine the extent of preventive measures for risk reduction of adverse drug reactions after contrast-enhanced CT examinations. 2. to prospectively determine the incidence and severity of adverse drug reactions occurring after administration of the iso-osmolar contrast medium iodixanol. 3. to determine a possible influence of preventive measures on the incidence/severity of adverse drug reactions.. Evaluable documentation was provided for 9953 patients from 66 radiology centers across Germany. Patient characteristics, aspects of iodixanol administration, and adverse events with an at least "possible" relationship were documented on a standardized case report form (CRF) and were evaluated up to seven days after contrast medium administration. About 55.5 % of patients showed one or more risk factors (e. g. impaired renal function 4.4 %, diabetes mellitus 8.5 %, hypertension 20.6 %). One third of the sites did not implement any preventive measures. Patients with a known risk for an allergy-like reaction were more likely to receive pharmacologic preventive treatment (0.5 - 50.5 %). Oral hydration was the main preventive measure in patients with renal risk factors (< 8 %) followed by intravenous hydration (1 %). Adverse drug reactions, mainly hypersensitivity reactions, occurred in 77 patients (0.74 %), but were classified as serious in only 3 patients (0.03 %). No statistically significant correlation between risk factors, preventive measures, and adverse reactions could be found. The use of preventive measures for CT examinations in this outpatient setting was generally low with risk patients being pre-medicated more often, depending on their history. In the routine outpatient setting, iso-osmolar iodixanol was very well tolerated in almost 10,000 patients undergoing diagnostic CT. The rate of acute and delayed adverse reactions was low. No correlation could be found

  11. [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.

  12. Hypothermia during Carotid Endarterectomy: A Safety Study

    PubMed Central

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

    2016-01-01

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

  13. Hypothermia during Carotid Endarterectomy: A Safety Study.

    PubMed

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

    2016-01-01

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

  14. 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.

  15. 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

  16. Safety pharmacology investigations in toxicology studies: an industry survey.

    PubMed

    Authier, Simon; Vargas, Hugo M; Curtis, Michael J; Holbrook, Mark; Pugsley, Michael K

    2013-01-01

    The Safety Pharmacology (SP) Society (SPS) conducted an industry survey in 2012 in an attempt to define current industry practices as they relate to inclusion of safety pharmacology (SP) endpoints into Toxicology studies. A total of 361 participants from Asia (9.1%), Europe (19.4%) and North America (71.4%) responded to the survey. The preponderance of respondents were toxicologists (53.2%) followed by safety pharmacologists (27.2%) and scientists involved in the conduct of both disciplines (19.6%). Most participants (58.6%) were from pharmaceutical companies employing more than 500 employees. A majority (68.2%) reported having experience in designing, performing or interpreting the SP component of a study when performed as part of a toxicology study. Some participants (42.0%) had submitted data to a regulatory agency where ICHS7 studies were performed as part of a toxicology study rather than as a standalone study. When comparing species that were used in studies in which SP was added to toxicology studies, canines were the most frequently reported animals used for new chemical entities (NCE) whereas non-human (NH) primates were the most frequent for the assessment of biological agents. The most frequent primary motivator for adding ICHS7 SP endpoints to regulatory toxicology studies was to generate additional data to allow for determination of an integrated risk assessment thereby testing Confidence in Safety (CIS) to better manage and/or mitigate risk. The current ability to add safety pharmacology endpoints into regulatory toxicology studies was used to address a specific concern (by 42.1% of respondents) to allow management of risk more effectively (36.8%) or to generate data that contributes to cessation of the progression of a compound (21.1%). For an NCE, SP measurements in toxicology studies were conducted in addition to standalone SP studies (by 40.6% of respondents) or in addition/instead of standalone safety pharmacology studies (by 39.8% of respondents

  17. Study on safety level of RC beam bridges under earthquake

    NASA Astrophysics Data System (ADS)

    Zhao, Jun; Lin, Junqi; Liu, Jinlong; Li, Jia

    2017-08-01

    This study considers uncertainties in material strengths and the modeling which have important effects on structural resistance force based on reliability theory. After analyzing the destruction mechanism of a RC bridge, structural functions and the reliability were given, then the safety level of the piers of a reinforced concrete continuous girder bridge with stochastic structural parameters against earthquake was analyzed. Using response surface method to calculate the failure probabilities of bridge piers under high-level earthquake, their seismic reliability for different damage states within the design reference period were calculated applying two-stage design, which describes seismic safety level of the built bridges to some extent.

  18. 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.

  19. 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

  20. 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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2015-01-01

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

  3. A Validation Study of the Revised Personal Safety Decision Scale

    ERIC Educational Resources Information Center

    Kim, HaeJung; Hopkins, Karen M.

    2017-01-01

    Objective: The purpose of this study is to examine the reliability and validity of an 11-item Personal Safety Decision Scale (PSDS) in a sample of child welfare workers. Methods: Data were derived from a larger cross-sectional online survey to a random stratified sample of 477 public child welfare workers in a mid-Atlantic State. An exploratory…

  4. 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.

  5. 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.

  6. 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.

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

    PubMed

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

    2014-09-01

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

  8. 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

  9. 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.

  10. Safety behavior and work safety climate among landscaping and groundskeeping workers in North Carolina: A pilot study.

    PubMed

    Kearney, Gregory D; Balanay, Jo Anne G; Mannarino, Adam J

    2017-01-01

    Each year, the average number of nonfatal occupational injuries among landscaping and groundskeeping workers are consistently above the total number of injuries for all other occupational injuries among worker in the U.S. From 2004 to 2007, fatalities among groundskeepers averaged 13.3 per 100,000 workers compared to an overall rate of 4.0 fatalities per 100,000 for all U.S. workers with the majority reported as either Hispanic or Latino. The aims of this project were to describe the use of personal protective equipment and work safety climate among a sample of landscaping and groundskeeping workers employed by public universities in North Carolina (N = 67). Data from a cross-sectional study was collected among workers using group- administered surveys. Statistical associations with work safety climate were tested between personal, work and safety behavior characteristics with work safety climate scores using one-way ANOVA. Nearly half of workers (49.3%) reported experiencing one or more work-related injuries or illnesses within the past 12 months. While work safety practices were perceived as being very important to management, only 56.7% reported having regular safety meetings. In bivariate analysis, work safety climate scores were significantly lower among those reporting race "other than white" (P = 0.01). This is the first study of its kind to evaluate work safety climate among landscaping and groundskeeping workers. Although self-reported safety practices were moderate, minority workers described their work safety climate as being poor. As a pilot study, these results suggest that employers of landscaping and groundskeeping workers could do more to improve safety climate within the organization with an emphasis on safety training for minority and underrepresented workers.

  11. 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

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

    PubMed

    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

    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. 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. 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 ε/patient, p<.0001) and safety syringes (21.5 ε/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 ε/patient (45.8 vs. 77.6 ε/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). 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.

  13. Ferrocyanide safety project ferrocyanide aging studies. Final report

    SciTech Connect

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

    1996-06-01

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

  14. 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

  15. [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.

  16. Modeling the Relationship between Safety Climate and Safety Performance in a Developing Construction Industry: A Cross-Cultural Validation Study.

    PubMed

    Zahoor, Hafiz; Chan, Albert P C; Utama, Wahyudi P; Gao, Ran; Zafar, Irfan

    2017-03-28

    This study attempts to validate a safety performance (SP) measurement model in the cross-cultural setting of a developing country. In addition, it highlights the variations in investigating the relationship between safety climate (SC) factors and SP indicators. The data were collected from forty under-construction multi-storey building projects in Pakistan. Based on the results of exploratory factor analysis, a SP measurement model was hypothesized. It was tested and validated by conducting confirmatory factor analysis on calibration and validation sub-samples respectively. The study confirmed the significant positive impact of SC on safety compliance and safety participation, and negative impact on number of self-reported accidents/injuries. However, number of near-misses could not be retained in the final SP model because it attained a lower standardized path coefficient value. Moreover, instead of safety participation, safety compliance established a stronger impact on SP. The study uncovered safety enforcement and promotion as a novel SC factor, whereas safety rules and work practices was identified as the most neglected factor. The study contributed to the body of knowledge by unveiling the deviations in existing dimensions of SC and SP. The refined model is expected to concisely measure the SP in the Pakistani construction industry, however, caution must be exercised while generalizing the study results to other developing countries.

  17. Modeling the Relationship between Safety Climate and Safety Performance in a Developing Construction Industry: A Cross-Cultural Validation Study

    PubMed Central

    Zahoor, Hafiz; Chan, Albert P. C.; Utama, Wahyudi P.; Gao, Ran; Zafar, Irfan

    2017-01-01

    This study attempts to validate a safety performance (SP) measurement model in the cross-cultural setting of a developing country. In addition, it highlights the variations in investigating the relationship between safety climate (SC) factors and SP indicators. The data were collected from forty under-construction multi-storey building projects in Pakistan. Based on the results of exploratory factor analysis, a SP measurement model was hypothesized. It was tested and validated by conducting confirmatory factor analysis on calibration and validation sub-samples respectively. The study confirmed the significant positive impact of SC on safety compliance and safety participation, and negative impact on number of self-reported accidents/injuries. However, number of near-misses could not be retained in the final SP model because it attained a lower standardized path coefficient value. Moreover, instead of safety participation, safety compliance established a stronger impact on SP. The study uncovered safety enforcement and promotion as a novel SC factor, whereas safety rules and work practices was identified as the most neglected factor. The study contributed to the body of knowledge by unveiling the deviations in existing dimensions of SC and SP. The refined model is expected to concisely measure the SP in the Pakistani construction industry, however, caution must be exercised while generalizing the study results to other developing countries. PMID:28350366

  18. Arrhythmias observed during high-G training: proposed training safety criterion.

    PubMed

    Hanada, Ryuzo; Hisada, Tetsuya; Tsujimoto, Tetsuya; Ohashi, Koichiro

    2004-08-01

    Most arrhythmias during centrifuge training are physiological responses to high +Gz stress. However, potentially dangerous arrhythmias occasionally occur during centrifuge training. We reviewed all arrhythmias recorded during the Japan Air Self-Defense Force (JASDF) centrifuge training from April 2001 to March 2003, and developed a criterion for suspending G-training based on observed arrhythmias. There were 195 male fighter pilots who received high-G centrifuge training monitored with electrocardiographs (ECGs). We evaluated types and occurrences of all arrhythmias during high-G training over a 24-mo period. Sinus arrhythmia (48.7%), single premature atrial contraction (32.3%), and single (58.5%) or paired (9.7%) premature ventricular contraction were commonly occurring arrhythmias during high-G training. We considered these arrhythmias as variant physiological responses to high-G training (category 1). In addition, we observed ventricular tachycardia (2.6%), paroxysmal supraventricular tachycardia (1.5%), and paroxysmal atrial fibrillation (0.5%). Further investigation of these trainees revealed a significant proportion with cardiac anomalies. As a result, the JASDF currently categorizes these arrhythmias as indicators to suspend G-training and initiate cardiac workup (category 3). Other arrhythmias, such as non-sustained ventricular tachycardia (VT) or Morbitz type I atrioventricular (AV) block, were considered borderline anomalies; whether training was allowed to continue depended on the decision of the physicians monitoring the training (category 2). Routine ECG monitoring during centrifuge training is recommended to catch the pathology underlying dangerous arrhythmias for flight safety. Our proposed criterion for stopping the centrifuge is intended to differentiate between serious arrhythmias and arrhythmias of physiologic response.

  19. 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

  20. Effectiveness and safety of infliximab in rheumatoid arthritis: analysis from a Canadian multicenter prospective observational registry.

    PubMed

    Thorne, Carter; Bensen, William G; Choquette, Denis; Chow, Andrew; Khraishi, Majed; Atkins, Christopher J; Kelsall, John T; Lehman, Allen J; Shawi, May; Khalil, Hayssam; Nantel, Francois; Rampakakis, Emmanouil; Sampalis, John S; Otawa, Susan

    2014-08-01

    To describe the profile of rheumatoid arthritis (RA) patients treated with infliximab in Canadian routine care and to assess the real-world effectiveness and safety of infliximab. Biologics-naive RA patients from the Biologic Treatment Registry Across Canada were stratified based on their enrollment year. Effectiveness was assessed with the changes in clinical/laboratory parameters and patient-reported outcomes and the achievement of minimal disease activity and remission. Safety was assessed with the incidence of treatment-emergent adverse events (AEs). Among 628 patients, 45.9%, 34.6%, and 19.6% were enrolled between 2002-2005, 2005-2008, and 2008-2011, respectively. Patients recruited in more recent years had significantly lower Disease Activity Score with a 28-joint count using the C-reactive protein level (DAS28-CRP), Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), swollen joint count in 28 joints, tender joint count in 28 joints, physician's global assessment of disease activity, patient's global assessment of disease activity, Health Assessment Questionnaire disability index, pain, erythrocyte sedimentation rate, and CRP level (P < 0.01 for all). Patient management also changed with a trend to initiate infliximab after failure of fewer disease-modifying antirheumatic drugs (DMARDs). Six-month treatment with infliximab resulted in statistically significant and clinically important improvements in all disease parameters examined, which were sustained over 36 months. The cumulative probability of achieving remission by 36 months, as defined by the DAS28, SDAI, and CDAI, was 56.2 (95% confidence interval [95% CI] 47.8-64.8), 31.0 (95% CI 23.8-39.8), and 36.2 (95% CI 28.5-45.3), respectively, which was significantly greater in patients with lower baseline disease activity. The profile and incidence of AEs were comparable to data previously reported for tumor necrosis factor α inhibitors. RA patient characteristics at infliximab

  1. Sociocultural contexts and worker safety and health: findings of a study with Chinese immigrant restaurant workers.

    PubMed

    Tsai, Jenny; Bruck, Annie

    2009-02-01

    More immigrants are seeking employment in restaurants. Drawing data from an ethnographic study, this article discusses what and how sociocultural contexts shape the safety and health of immigrant restaurant workers. Eighteen Chinese immigrants from China, Hong Kong, and Taiwan participated in the study. Data generation methods included a questionnaire, individual and focus group interviews, and participant observations. Ethnographic analysis revealed that immigration mechanisms, demands of English proficiency for employment, and existence of networks and ethnic communities shaped the participants' employment choices. Working hours and schedules, interpersonal relationships at work, job design and training, occupational safety and health training, and national events and economy further influenced the participants' occupational experiences and well-being. Issues were noted with job security, mental health, family relationships, and risks for occupational injuries and illnesses. Implications for occupational health nursing research and practice to reduce immigrant workers' vulnerability to poor safety and health outcomes conclude this article.

  2. 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...

  3. Observing Protein & Energy Nutrition (OPEN) Study

    Cancer.gov

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

  4. Community Engagement in Observational Human Exposure Studies

    EPA Science Inventory

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

  5. Applying ethnography to the study of context in healthcare quality and safety.

    PubMed

    Leslie, Myles; Paradis, Elise; Gropper, Michael A; Reeves, Scott; Kitto, Simon

    2014-02-01

    Translating and scaling healthcare quality improvement (QI) and patient safety interventions remains a significant challenge. Context has been identified as a major factor in this. QI and patient safety research have begun to focus on context, with ethnography seen as a promising methodology for understanding the professional, organisational and cultural aspects of context. While ethnography is used to investigate the context of a variety of QI and safety interventions, the challenges inherent in effectively importing a qualitative methodology and its social science practitioners into this work have been largely unexamined. We explain ethnography as a research practice grounded in theory and dependent on observations gathered and interpreted in particular ways. We then review the approach of health services literature to evaluating this sort of qualitative research. Although the study of context is an interest shared by both social scientists and healthcare QI and safety researchers, we identify three key points at which those 'exporting' ethnography as a methodology and those 'importing' it to deal with QI and safety challenges may diverge. We describe perspectival divergences on the methodology's mission, form and scale. At the level of mission we demonstrate how ethnography has been adapted to a 'describe and feed back' role in the service of QI. At the level of form, we show how the long-term embedded observation at the heart of ethnography can be adapted only so far to accommodate QI interests if both data quality and ethical standards are to be upheld. Finally, at the level of scale, we demonstrate one ethnographic study design that balances breadth of exposure with depth of experience in its observations and so generates a particular type of scalable findings. The effective export of ethnography into QI and safety research requires discussion and negotiation between social scientific and health services research perspectives, as well as creative approaches

  6. 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.

  7. 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".

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

    NASA Astrophysics Data System (ADS)

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

    2014-09-01

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

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

    PubMed

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

    2013-05-01

    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. 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. 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. Implementation of the SSC had rather limited impact on the safety culture within this hospital.

  10. 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.

  11. 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…

  12. 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…

  13. 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.

  14. 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. Copyright © AULA MEDICA EDICIONES 2013. Published by AULA MEDICA. All rights reserved.

  15. [Clinical observation of the impacts and safety of electroacupuncture at Sanyinjiao (SP 6) on labor].

    PubMed

    Liu, Ya-Li; Jin, Zhi-Gao

    2012-05-01

    To observe the impacts of electroacupuncture (EA) at Sanyinjiao (SP 6) on labor and assess its safety. The random and single-blind method was adopted to divide 111 cases of the puerperas of natural delivery into an EA group (38 cases), a sham-acupuncture group (37 cases) and a blank control group (36 cases). In EA group, Sanyinjiao (SP 6) was selected and stimulated with Han's acupoint nerve stimulator (HANS). In the sham-acupuncture group, the puerperas were stimulated only with the needle tube, needle removed in advance and they felt subjectively to be needled. Afterward, the filiform needle was attached to Sanyinjiao (SP 6) with the needle tip wrapped with the adhesive plaster in advance, then HANS which one conducting wire was cut off in was connected. In the blank control group, no any treatment was applied, but the same indices were recorded at corresponding time points. The blood pressure and the heart rate of the puerperas as well as the heart rate of fetus were measured in 20 min of EA and 30 min after needle removal in three groups separately. The bleeding 24 h after labor and 1 min Apger score of the newborns were observed. In EA group, the active phase of the 1st labor stage ((4.38 +/- 1.76)h) was shorter than that ((5.28 +/- 2.41)h) in the blank control group and that ((5.38 +/- 2.36)h) in the sham-acupuncture group, presenting statistically significant differences (all P < 0.05). In the latent phase of the 1st labor stage and the 2nd and 3rd stages, in the comparison of the blood pressure and the heart rate of the puerperas as well as the heart rate of fetus after EA, the bleeding 24 h after labor and 1 min Apger score of the newborns among three groups, there were no statistically significant differences (all P > 0.05). EA at Sanyinjiao (SP 6) can shorten the duration of the active phase of the 1st labor stage. It is safe for either the puerpera or the fetus and can assist the parturition quality in clinic.

  16. Relationship between preventable hospital deaths and other measures of safety: an exploratory study

    PubMed Central

    Hogan, Helen; Healey, Frances; Neale, Graham; Thomson, Richard; Vincent, Charles; Black, Nick

    2014-01-01

    Objective To explore associations between the proportion of hospital deaths that are preventable and other measures of safety. Design Retrospective case record review to provide estimates of preventable death proportions. Simple monotonic correlations using Spearman's rank correlation coefficient to establish the relationship with eight other measures of patient safety. Setting Ten English acute hospital trusts. Participants One thousand patients who died during 2009. Results The proportion of preventable deaths varied between hospitals (3–8%) but was not statistically significant (P = 0.94). Only one of the eight measures of safety (Methicillin-resistant Staphylococcus aureus bacteraemia rate) was clinically and statistically significantly associated with preventable death proportion (r = 0.73; P < 0.02). There were no significant associations with the other measures including hospital standardized mortality ratios (r = −0.01). There was a suggestion that preventable deaths may be more strongly associated with some other measures of outcome than with process or with structure measures. Conclusions The exploratory nature of this study inevitably limited its power to provide definitive results. The observed relationships between safety measures suggest that a larger more powerful study is needed to establish the inter-relationship of different measures of safety (structure, process and outcome), in particular the widely used standardized mortality ratios. PMID:24781497

  17. [Critical reading of analytical observational studies].

    PubMed

    García Villar, C; Marín León, I

    2015-11-01

    Analytical observational studies provide very important information about real-life clinical practice and the natural history of diseases and can suggest causality. Furthermore, they are very common in scientific journals. The aim of this article is to review the main concepts necessary for the critical reading of articles about radiological studies with observational designs. It reviews the characteristics that case-control and cohort studies must have to ensure high quality. It explains a method of critical reading that involves checking the attributes that should be evaluated in each type of article using a structured list of specific questions. It underlines the main characteristics that confer credibility and confidence on the article evaluated. Readers are provided with tools for the critical analysis of the observational studies published in scientific journals. Copyright © 2014 SERAM. Published by Elsevier España, S.L.U. All rights reserved.

  18. Surgical safety checklist is associated with improved operating room safety culture, reduced wound complications, and unplanned readmissions in a pilot study in neurosurgery.

    PubMed

    Lepänluoma, M; Takala, R; Kotkansalo, A; Rahi, M; Ikonen, T S

    2014-03-01

    The World Health Organization's surgical safety checklist is designed to improve adherence to operating room safety standards, and its use has been shown to reduce complications among surgical patients. The objective of our study was to assess the impact of the implementation of the checklist on safety-related issues in the operating room and on postoperative adverse events in neurosurgery. From structured questionnaires delivered to operating room personnel, answers were analyzed to evaluate communication and safety-related issues during 89 and 73 neurosurgical operations before and after the checklist implementation, respectively. From the analyzed operations, 83 and 67 patients, respectively, were included in a retrospective analysis of electronic patient records to compare the length of hospital stay, reported adverse events, and readmissions. In addition, the consistency of operating room documentation and patient records was assessed. Communication between the surgeon and the anesthesiologist was enhanced, and safety-related issues were better covered when the checklist was used. Unplanned readmissions fell from 25% to 10% after the checklist implementation (p = 0.02). Wound complications decreased from 19% to 8% (p = 0.04). The consistency of documentation of the diagnosis and the procedure improved. The use of the checklist improved safety-related performance and, contemporarily, reduced numbers of wound complications, and readmissions were observed.

  19. Managing Indigent Care: A Case Study of a Safety-Net Emergency Department

    PubMed Central

    Dohan, Daniel

    2002-01-01

    Objective To examine how one safety-net emergency department (ED) managed problems associated with the provision of indigent care in everyday life. Data Sources/Study Setting Interview and observational data collected in County Hospital ED, a public teaching hospital in a California city, during 6 months of 1999. Study Design The study used ethnographic methods to document and understand day-to-day routines and practices for providing indigent care in a safety-net facility. Data Collection/Extraction Methods One- to 2-hour semistructured interviews with a snowball sample of eight ED physicians were tape recorded, and fieldnotes were recorded in situ during 10–30 hours of participant observation per week in all areas of the ED. Data were coded to highlight themes of interest and to identify recurrent patterns of behavior. Principal Findings In everyday life, providers at County ED relied on graduate medical education (GME) to manage two everyday problems, social use and tenuous financing, associated with the provision of indigent care. GME helped manage problematic social visits to the ED by defining them as interesting cases. GME helped with tenuous finances by creating a work culture that encouraged the provision of uncompensated work. Conclusions Safety-net facilities often face problems similar to those in County ED. Future research should assess the extent to which the everyday management of these problems in County ED resembles that in other safety-net facilities. PMID:12035998

  20. 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.

  1. Study on occupational safety and health strategy for Taiwan.

    PubMed

    Chuang, Kuen-Yuan; Su, Teh-Sheng; Kuo, Chao-Yin; Lin, Chien-Liang; Lin, Han-Yu; Yu, Yi-Chun

    2009-12-01

    The aim of this study was to establish a set of occupational safety and health (OSH) issues and development policies suitable for adoption in Taiwan. A survey was conducted on a sample of 102 experts and 235 industrial work safety personnel in Taiwan for statistical analysis of the general consensus, with the results showing such consensus in 104 individual policy indicators. Our results reveal that the most appropriate targets were considered to be annual 10% reductions in the 'occupational accident disability rate', 'occupational accident injury rate' and 'occupational diseases before 2010'. Responding to the specific question of the appropriate method of achieving a reduction in the number of accidents in Taiwan, the primary consideration for 13.4% of the experts and 10.6% of the industry personnel was 'promoting OSH awareness and enhancing the overall safety culture'. As regards the current OSH policy focus, 11.2% of the experts considered 'improving OSH legislation, standards and systems' to be the most important, whilst 8.9% of the industry personnel felt that 'recognizing work stress, overwork and emerging OSH issues' were the most important.

  2. Pharmaceuticals Safety Practices-A Comparative Pilot Study

    PubMed Central

    Tawfik, Kamilia A.; Jabeen, Arshia

    2013-01-01

    Introduction The safety of medicine is essential for the safety of patients. Inappropriate drug storage, expiration dates, sharing prescription drugs, self medication habits and misuse of some drugs are contributing factors affecting medication safety. One or more of these factors may lead to serious health complications and even death. Objectives The purpose of this study was to highlight the common errors and pharmaceutical malpractices that people usually engage in on a daily basis and to correlate these to culture, gender and educational levels. This may spread awareness in an easy and understandable manner and provide certain guidelines to drug consumers ensuring that pharmaceutical preparations are used correctly and safely. Methods Two hundred questionnaires were randomly distributed in two countries; Saudi Arabia and India. The collected data were statistically analyzed. Outcomes and conclusion Results showed that alarming percentages of various participants were using pharmaceuticals inappropriately due to carelessness, unawareness or intentional mistakes. Therefore, active participation by health care professionals is essential for the prevention of drug misuse. Increasing population awareness about self medication, products expiration, pharmaceuticals labels and optimum storage conditions would minimize the adverse effects and may even be life saving. PMID:24533025

  3. Pharmaceuticals safety practices-a comparative pilot study.

    PubMed

    Tawfik, Kamilia A; Jabeen, Arshia

    2013-11-01

    The safety of medicine is essential for the safety of patients. Inappropriate drug storage, expiration dates, sharing prescription drugs, self medication habits and misuse of some drugs are contributing factors affecting medication safety. One or more of these factors may lead to serious health complications and even death. The purpose of this study was to highlight the common errors and pharmaceutical malpractices that people usually engage in on a daily basis and to correlate these to culture, gender and educational levels. This may spread awareness in an easy and understandable manner and provide certain guidelines to drug consumers ensuring that pharmaceutical preparations are used correctly and safely. Two hundred questionnaires were randomly distributed in two countries; Saudi Arabia and India. The collected data were statistically analyzed. Results showed that alarming percentages of various participants were using pharmaceuticals inappropriately due to carelessness, unawareness or intentional mistakes. Therefore, active participation by health care professionals is essential for the prevention of drug misuse. Increasing population awareness about self medication, products expiration, pharmaceuticals labels and optimum storage conditions would minimize the adverse effects and may even be life saving.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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.

  9. Study on attitudes of students of Islamic Azad University Tehran Medical Branch toward food safety, 2016.

    PubMed

    Miri, Ali; Poursadeghiyan, Mohsen; Baneshi, Mohammad Mehdi; Biglari, Hamed; Yari, Ahmad Reza; Khammar, Alireza

    2017-05-01

    Given the importance of high-quality healthy food for humans, contamination control is the most important concern for healthy staff. To determine the attitudes of students at Islamic Azad University (Tehran Medical Branch) toward food safety. This cross-sectional and analytic-descriptive study was conducted on 326 students of Azad University of Medical Sciences in 2016. A self-made questionnaire consisting of 40 questions was used. The reliability of the questionnaire was confirmed using internal consistency method (Cronbach's alpha coefficient of 0.80). After collecting data, we use descriptive statistical indexes (mean and standard deviation) among demographic variables and the level of knowledge to describe and analyze the data. The participants' attitudes and operation are measured by Spearman tests, and the analytical results are given using SPSS version 20. According to the findings, 55.3, 30 and 14.7 percent of students had high, moderate and low attitude scores toward food safety, respectively. In addition, male and female students had equal attitudes toward food safety, and no significant relationship between sex and attitude was observed a significant difference (p>0.05), but between educational levels (p=0.008) and ages (p=0.001) of students significance was a positive correlation. Due to the low attitudes score of about half of the students of Islamic Azad University Tehran Medical Branch toward food safety, it can be claimed, food safety training in this community is required.

  10. Impact of health education intervention on food safety and hygiene of street vendors: A pilot study.

    PubMed

    Singh, Ansk Kumar; Dudeja, Puja; Kaushal, Nitin; Mukherji, Sandip

    2016-07-01

    Street foods are major source of food to millions of people. However, these are frequently associated with food-borne illnesses. It is imperative that street food vendors are educated to maintain hygiene and hence safety of food. With this background, a pilot study was undertaken to assess the impact of health education intervention on food safety and hygiene of street vendors. The aim of this study was to assess impact of health education intervention on food safety of street vendors. It was a before and after study conducted in twenty street vendors of an urban area. Tool based on Bureau of Indian Standards (BIS) 2012 was prepared with scoring system to rate hygiene and sanitation of street vendors (score 0-156). Health education was given to all and scores of these vendors on same tool were reassessed after four weeks. Mean age of the study subjects was 35 ± 13.2 years. Highest score attained in BIS tool for food safety was 104 out of 156 (66.6%). No vendor was found to have achieved excellent score. Reasons for poor score were poor condition of vending cart, location, lack personal hygiene and incorrect and unsafe food handling practices. After intervention, it was observed that there was no significant improvement in overall score of vendors. However, scores in domains of personal habits, hygiene and food handling practices improved significantly after intervention (p < 0.05). The street vendors do not meet required standards given by BIS for food safety. Health education alone can only partly improve food safety practices of street vendors.

  11. Factors that drive team participation in surgical safety checks: a prospective study.

    PubMed

    Gillespie, Brigid M; Withers, Teresa K; Lavin, Joanne; Gardiner, Therese; Marshall, Andrea P

    2016-01-01

    Team-based group communications using checklists are widely advocated to achieve shared understandings and improve patient safety. Despite the positive effect checklists have on collaborations and reduced postoperative complications, their use has not been straightforward. Previous research has described contextual factors that impact on the implementation of checklists, however there is limited understanding of the issues that impede team participation in checklist use in surgery. The aim of this prospective study was to identify and describe factors that drive team participation in safety checks in surgery. We observed ten surgical teams and conducted 33 semi-structured interviews with 70 participants from nursing, surgery and anaesthetics, and the community. Constant comparative methods were used to analyse textual data derived from field notes and interviews. Observational and interview data were collected during 2014-15. Analysis of the textual data generated from the field notes and interviews revealed the extent to which members of the surgical team participated in using the surgical safety checklist during each phase of patient care. These three categories included: 'using the checklist'; 'working independently'; and, 'communicating checks with others'. The phases in the checking process most vulnerable to information loss or omission were sign in and sign out. Team participation in safety checks depends on a convergence of intertwined factors; namely, team attributes, communication strategies and checking processes. A whole-of-team approach to participation in surgical safety checks is far more complex when considering the factors that drive participation. Strategies to increase participation in safety checks need to target professional communication practices and work processes such as workflow which curtail team members' ability to participate.

  12. 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.

  13. 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…

  14. 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…

  15. A roadside study of observable driver distractions.

    PubMed

    Sullman, Mark J M; Prat, Francesc; Tasci, Duygu Kuzu

    2015-01-01

    This study investigated the prevalence of observable distractions while driving and the effect of drivers' characteristics and time-related variables on their prevalence. Using roadside observation, 2 independent observers collected data at 4 randomly selected locations in St. Albans, UK. Of the 10,984 drivers observed, 16.8% were engaged in a secondary task, with talking to passengers being the most common distraction (8.8%), followed by smoking (1.9%) and talking on a hands-free mobile phone (1.7%). An additional 1.0% were observed talking on a handheld phone, and the rest of the distractions (e.g., texting, drinking) were recorded in less than 1% of the drivers observed. Gender-related differences were found for a number of different distractions (i.e., talking to passengers, drinking, and handheld mobile phone conversations), but age emerged as a significant predictor for most secondary tasks, including talking to passengers, smoking, hands-free mobile phone use, handheld mobile phone use, texting/keying numbers, drinking, and engagement in any type of distraction (all distractions combined). The overall pattern for age was that middle-aged and older drivers were less likely to be distracted than younger drivers. This work provides further evidence of the relatively high rate of distracted driving in the UK. The findings clearly indicate that younger drivers are more likely to drive distracted, which probably contributes to their higher crash rates.

  16. 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

  17. 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.

  18. Studying the Relationship between Individual and Organizational Factors and Nurses' Perception of Patient Safety Culture.

    PubMed

    Abdolahzadeh, Farahnaz; Zamanzadeh, Vahid; Boroumand, Aniroda

    2012-12-01

    Safety culture is considered as an important factor in improving patient safety. Therefore, identifying individual and organizational factors affecting safety culture is crucial. This study was carried out to determine individual and organizational factors associated with nurses' perception of patient safety culture. The present descriptive study included 940 nurses working in four training hospitals affiliated with Urmia University of Medical Sciences (Iran). Data was collected through the self-report questionnaire of patient safety culture. Descriptive (number, percent, mean, and standard deviation) and inferential (t-test and analysis of variance) statistics were used to analyze the data in SPSS. Nurses' perception of patient safety culture was significantly correlated with marital status, workplace, and overtime hours. The results of this study revealed that some individual and organizational factors can impact on nurses' perception of patient safety culture. Nursing authorities should thus pay more attention to factors which promote patient safety culture and ultimately the safety of provided services.

  19. 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

  20. En Route Patient Safety: A Mixed-Methods Study

    DTIC Science & Technology

    2014-03-01

    during air staging and aeromedical evacuation (AE). An important step in improving patient safety is to identify gaps in patient care and examine...personnel/crew safety is important to those en route care personnel who participated. However, there were mixed thoughts whether the mission or patient ... safety were evident as a range of patient safety concerns and proposed solutions emerged from the focus group discussions. The importance of teamwork

  1. 40 CFR 720.90 - Data from health and safety studies.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Data from health and safety studies... 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 business...

  2. 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...

  3. 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. © 2016 The Authors. The Journal of Dermatology published by John Wiley & Sons Australia, Ltd on behalf of Japanese Dermatological Association.

  4. 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

  5. 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

  6. Safe medication management in specialized home healthcare - an observational study.

    PubMed

    Lindblad, Marléne; Flink, Maria; Ekstedt, Mirjam

    2017-08-24

    Medication management is a complex, error-prone process. The aim of this study was to explore what constitutes the complexity of the medication management process (MMP) in specialized home healthcare and how healthcare professionals handle this complexity. The study is theoretically based in resilience engineering. Data were collected during the MMP at three specialized home healthcare units in Sweden using two strategies: observation of workplaces and shadowing RNs in everyday work, including interviews. Transcribed material was analysed using grounded theory. The MMP in home healthcare was dynamic and complex with unclear boundaries of responsibilities, inadequate information systems and fluctuating work conditions. Healthcare professionals adapted their everyday clinical work by sharing responsibility and simultaneously being authoritative and preserving patients' active participation, autonomy and integrity. To promote a safe MMP, healthcare professionals constantly re-prioritized goals, handled gaps in communication and information transmission at a distance by creating new bridging solutions. Trade-offs and workarounds were necessary elements, but also posed a threat to patient safety, as these interim solutions were not systematically evaluated or devised learning strategies. To manage a safe medication process in home healthcare, healthcare professionals need to adapt to fluctuating conditions and create bridging strategies through multiple parallel activities distributed over time, space and actors. The healthcare professionals' strategies could be integrated in continuous learning, while preserving boundaries of safety, instead of being more or less interim solutions. Patients' and family caregivers' as active partners in the MMP may be an underestimated resource for a resilient home healthcare.

  7. Novel technology to prepare oral formulations for preclinical safety studies.

    PubMed

    Niwa, Toshiyuki; Hashimoto, Naofumi

    2008-02-28

    A novel method to prepare oral formulations, normally suspended dosage form, for preclinical safety studies in animals has been developed using a rotation/revolution mixer. Small hard balls made of zirconia were added to the mixing process to evaluate effectiveness in making a high quality suspension. The driving with balls loaded in the cylindrical container (vessel) of the mixer was quite efficient in dispersing and milling the particles of the active pharmaceutical ingredient (API) in an aqueous medium. The API powder and a small amount of oral aqueous medium (vehicle) were successfully mixed by the spinning motion of the balls in the vessel as though the paste-like suspension was kneaded with a mortar and pestle. It was found that the milled suspension with the mean size of 10-20microm could be prepared, in addition finer milling of less than 10microm could be achieved by selecting the material of vessel. Optimum driving conditions including mixing time, size and quantity of balls, and the standard operational procedure was established using compounds varying in physicochemical properties. The particle size and quantitative analysis by HPLC showed that the resultant suspension was well-milled and highly homogeneous with the nearly intended concentration of API. The proposed method established by this experiment could be applied to the actual safety studies in the real preparation scale of oral suspension.

  8. 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.; hide

    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.

  9. 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

  10. 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.

  11. 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

  12. Safety and tolerability of rufinamide in children with epilepsy: a pooled analysis of 7 clinical studies.

    PubMed

    Wheless, James W; Conry, Joan; Krauss, Gregory; Mann, Allison; LoPresti, Antonia; Narurkar, Milind

    2009-12-01

    Rufinamide is a novel antiepileptic agent recently approved in the United States for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome. To help inform clinical decision making, the authors analyzed safety and tolerability data from the entire pediatric population in the rufinamide epilepsy clinical development program. The analysis population comprised 212 rufinamide-treated (age range 3-16 years) and 197 placebo patients (age range 4-17 years) in the double-blind studies, and 391 patients receiving rufinamide in the double-blind and/or open-label extensions. The most common adverse effects observed in rufinamide-treated patients in the double-blind studies were somnolence, vomiting, and headache. Changes in laboratory values, vital signs, and weight were generally clinically insignificant. This pooled analysis of data from pediatric patients in clinical studies of rufinamide for the treatment of seizures, mainly as adjunctive therapy, suggests a favorable safety and tolerability profile in this patient population.

  13. 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..., 2012. FOR FURTHER INFORMATION CONTACT: Price Connor, PhD, Executive Secretary, Safety and Occupational...

  14. Rates of public investment for road safety in developing countries: case studies of Uganda and Pakistan.

    PubMed

    Bishai, David; Hyder, Adnan A; Ghaffar, Abdul; Morrow, Richard H; Kobusingye, Olive

    2003-06-01

    This paper assesses the magnitude of public investment in road safety in Uganda and Pakistan. The study reviewed government budgetary records on expenditure for road safety for each country, as well as World Bank estimates of bilateral and NGO assistance directed to road safety. The authors interviewed key informants in each government who would know about public or NGO activity on road safety. Budgetary expenditure on road safety at all levels of government in Uganda and Pakistan is $0.09 and $0.07 per capita respectively. The scale of public activity in road safety in Uganda and Pakistan is extremely limited. If there are diminishing returns to scale for road safety investments, this would suggest that the potential effectiveness of properly chosen safety measures could never be higher. Large reductions in morbidity and mortality are likely if investment in road safety is expanded.

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

    PubMed

    Wright, Jim A; Yang, Hong; Rivett, Ulrike; Gundry, Stephen W

    2012-07-27

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

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

    PubMed Central

    2012-01-01

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

  17. 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.

  18. 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.

  19. A qualitative study of speaking out about patient safety concerns in intensive care units.

    PubMed

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

    2017-09-22

    Much policy focus has been afforded to the role of "whistleblowers" in raising concerns about quality and safety of patient care in healthcare settings. However, most opportunities for personnel to identify and act on these concerns are likely to occur much further upstream, in the day-to-day mundane interactions of everyday work. Using qualitative data from over 900 h of ethnographic observation and 98 interviews across 19 English intensive care units (ICUs), we studied how personnel gave voice to concerns about patient safety or poor practice. We observed much low-level social control occurring as part of day-to-day functioning on the wards, with challenges and sanctions routinely used in an effort to prevent or address mistakes and norm violations. Pre-emptions were used to intervene when patients were at immediate risk, and included strategies such as gentle reminders, use of humour, and sharp words. Corrective interventions included education and evidence-based arguments, while sanctions that were applied when it appeared that a breach of safety had occurred included "quiet words", bantering, public exposure or humiliation, scoldings and brutal reprimands. These forms of social control generally functioned effectively to maintain safe practice. But they were not consistently effective, and sometimes risked reinforcing norms and idiosyncratic behaviours that were not necessarily aligned with goals of patient safety and high-quality healthcare. Further, making challenges across professional boundaries or hierarchies was sometimes problematic. Our findings suggest that an emphasis on formal reporting or communication training as the solution to giving voice to safety concerns is simplistic; a more sophisticated understanding of social control is needed. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  20. 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.

  1. 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.

  2. 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].

  3. Observed and Expected Mortality in Cohort Studies.

    PubMed

    Richardson, David B; Keil, Alexander P; Cole, Stephen R; MacLehose, Richard F

    2017-03-15

    Epidemiologists often compare the observed number of deaths in a cohort with the expected number of deaths, obtained by multiplying person-time accrued in the cohort by mortality rates for a reference population (ideally, a reference that represents the mortality rate in the cohort in the absence of exposure). However, if exposure is hazardous (or salutary), this calculation will not consistently estimate the number of deaths expected in the absence of exposure because exposure will have affected the distribution of person-time observed in the study cohort. While problems with interpretation of this standard calculation of expected counts were discussed more than 2 decades ago, these discussions had little impact on epidemiologic practice. The logic of counterfactuals may help clarify this topic as we revisit these issues. In this paper, we describe a simple way to consistently estimate the expected number of deaths in such settings, and we illustrate the approach using data from a cohort study of mortality among underground miners. © The Author 2017. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  4. 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…

  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. Driver characteristics associated with child safety seat usage in Malaysia: a cross-sectional study.

    PubMed

    Kulanthayan, S; Razak, Ahmad; Schenk, Ellen

    2010-03-01

    The rapidly motorizing environment in Malaysia has made child occupant safety a current public health concern. The usage of child safety seats (CSS) is a widely regarded intervention to enhance child occupant safety, yet no study has been conducted on CSS in Malaysia. This study aims to determine the CSS usage rates in Malaysia and to assess driver characteristics that are associated with CSS usage. Nine variables - urban versus rural study location, age, gender, marital status, educational status, monthly family income, number of children present in the vehicle, distance traveled to the study location, and attitude - were examined through a cross-sectional study of interviewing drivers of 230 vehicles transporting at least one child <10 years of age at the time of the study. The vehicles were also observed for whether or not there was a CSS present. The interviews were conducted at six sampling locations - three urban and three rural - in the state of Melaka. 27.4% of the drivers were found to be using at least one CSS at the time of the survey. Among the nine variables studied, three of the driver characteristics showed statistical significance (p<0.05) with CSS usage: age (p=0.047), educational status (p=0.009), and attitude (p=0.009). This study begins to create knowledge on child occupant safety in Malaysia. The results indicate that interventional efforts should focus on educational programs geared toward drivers that are less educated or extended family members who inconsistently transport young children. Furthermore, any educational efforts could be strongly enhanced by legislation mandating the use of CSS. Every effort should be made to thoroughly assess the effectiveness of any educational or legislative activities that are implemented. Copyright 2009 Elsevier Ltd. All rights reserved.

  7. Sun Safety at Work Canada: a multiple case-study protocol to develop sun safety and heat protection programs and policies for outdoor workers.

    PubMed

    Kramer, Desre M; Tenkate, Thomas; Strahlendorf, Peter; Kushner, Rivka; Gardner, Audrey; Holness, D Linn

    2015-07-10

    CAREX Canada has identified solar ultraviolet radiation (UV) as the second most prominent carcinogenic exposure in Canada, and over 75 % of Canadian outdoor workers fall within the highest exposure category. Heat stress also presents an important public health issue, particularly for outdoor workers. The most serious form of heat stress is heat stroke, which can cause irreversible damage to the heart, lungs, kidneys, and liver. Although the need for sun and heat protection has been identified, there is no Canada-wide heat and sun safety program for outdoor workers. Further, no prevention programs have addressed both skin cancer prevention and heat stress in an integrated approach. The aim of this partnered study is to evaluate whether a multi-implementation, multi-evaluation approach can help develop sustainable workplace-specific programs, policies, and procedures to increase the use of UV safety and heat protection. This 2-year study is a theory-driven, multi-site, non-randomized study design with a cross-case analysis of 13 workplaces across four provinces in Canada. The first phase of the study includes the development of workplace-specific programs with the support of the intensive engagement of knowledge brokers. There will be a three-points-in-time evaluation with process and impact components involving the occupational health and safety (OHS) director, management, and workers with the goal of measuring changes in workplace policies, procedures, and practices. It will use mixed methods involving semi-structured key informant interviews, focus groups, surveys, site observations, and UV dosimetry assessment. Using the findings from phase I, in phase 2, a web-based, interactive, intervention planning tool for workplaces will be developed, as will the intensive engagement of intermediaries such as industry decision-makers to link to policymakers about the importance of heat and sun safety for outdoor workers. Solar UV and heat are both health and safety hazards

  8. 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

  9. Learning health 'safety' within non-technical skills interprofessional simulation education: a qualitative study.

    PubMed

    Gordon, Morris; Fell, Christopher W R; Box, Helen; Farrell, Michael; Stewart, Alison

    2017-01-01

    Healthcare increasingly recognises and focusses on the phenomena of 'safe practice' and 'patient safety.' Success with non-technical skills (NTS) training in other industries has led to widespread transposition to healthcare education, with communication and teamwork skills central to NTS frameworks. This study set out to identify how the context of interprofessional simulation learning influences NTS acquisition and development of 'safety' amongst learners. Participants receiving a non-technical skills (NTS) safety focussed training package were invited to take part in a focus group interview which set out to explore communication, teamwork, and the phenomenon of safety in the context of the learning experiences they had within the training programme. The analysis was aligned with a constructivist paradigm and took an interactive methodological approach. The analysis proceeded through three stages, consisting of open, axial, and selective coding, with constant comparisons taking place throughout each phase. Each stage provided categories that could be used to explore the themes of the data. Additionally, to ensure thematic saturation, transcripts of observed simulated learning encounters were then analysed. Six themes were established at the axial coding level, i.e., analytical skills, personal behaviours, communication, teamwork, context, and pedagogy. Underlying these themes, two principal concepts emerged, namely: intergroup contact anxiety - as both a result of and determinant of communication - and teamwork, both of which must be considered in relation to context. These concepts have subsequently been used to propose a framework for NTS learning. This study highlights the role of intergroup contact anxiety and teamwork as factors in NTS behaviour and its dissipation through interprofessional simulation learning. Therefore, this should be a key consideration in NTS education. Future research is needed to consider the role of the affective non

  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. A study for safety and health management problem of semiconductor industry in Taiwan.

    PubMed

    Chao, Chin-Jung; Wang, Hui-Ming; Feng, Wen-Yang; Tseng, Feng-Yi

    2008-12-01

    The main purpose of this study is to discuss and explore the safety and health management in semiconductor industry. The researcher practically investigates and interviews the input, process and output of the safety and health management of semiconductor industry by using the questionnaires and the interview method which is developed according to the framework of the OHSAS 18001. The result shows that there are six important factors for the safety and health management in Taiwan semiconductor industry. 1. The company should make employee clearly understand the safety and health laws and standards. 2. The company should make the safety and health management policy known to the public. 3. The company should put emphasis on the pursuance of the safety and health management laws. 4. The company should prevent the accidents. 5. The safety and health message should be communicated sufficiently. 6. The company should consider safety and health norm completely.

  12. 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).

  13. Multicenter study on the safety of bariatric endoscopy.

    PubMed

    Espinet Coll, Eduardo; Nebreda Durán, Javier; López-Nava Breviere, Gontrand; Ducóns García, Julio; Rodríguez-Téllez, Manuel; Crespo García, Javier; Marra-López Valenciano, Carlos

    2017-05-01

    Bariatric endoscopy includes a series of specific techniques focused on the management of obese patients. As a quality criterion, safety as expressed by a minimal incidence of serious complications is required in addition to efficacy. A descriptive, retrospective, multicenter review of the experience recorded at seven hospitals included in the Grupo Español de Endoscopia Bariátrica (GETTEMO) in order to document the incidence, cause, and resolution (including legal consequences) of serious complications reported for each bariatric technique, and according to endoscopist expertise. In all, 6,771 bariatric endoscopic procedures were collected, wherein 57 serious complications (0.84%) were identified. Balloons: Orbera®-Medsil®, 5/5,589; Spatz2® (older model): 44/225; Heliosphere®: 1/70; Obalon®: 0/107. Sutures: POSE®, 5/679; sleeve gastroplasty with Apollo® system: 0/55. Prostheses: Endobarrier®: 2/46. All complications were resolved with medical/endoscopic management except for five cases (0.07%) that required surgery. A single lawsuit occurred (esophageal perforation with Spatz2® balloon), which had a favorable outcome. There was no mortality, and apparently no differences were found according to endoscopist expertise level. In our multicenter experience, bariatric endoscopy may be considered as a safe procedure (0.84% of serious complications in all). However, some devices may induce a higher proportion of complications, such as 19.55% for Spatz2® balloons (already replaced) or 4.34% for Endobarrier® sleeves (at the upper limit of accepted safety), although our experience with the latter is limited. All complications were resolved with conservative medical management, and only exceptionally required surgery (0.07%). No technique-related mortality was seen, and only one lawsuit occurred. Further evolutionary studies are required on the novel endoscopic techniques presently emerging to authenticate our results.

  14. Treatment for Adolescents With Depression Study (TADS): Safety Results

    PubMed Central

    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

    2012-01-01

    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 measures for specific physical and psychiatric symptoms. Suicidal ideation and suicidal behavior were systematically assessed by self- and clinician reports. Suicidal events were also reanalyzed by the Columbia Group and expert raters using the Columbia-Classification Algorithm for Suicidal Assessment used in the U.S. Food and Drug Administration reclassification effort. Results Depressed adolescents reported high rates of physical symptoms at baseline, which improved as depression improved. Sedation, insomnia, vomiting, and upper abdominal pain occurred in at least 2% of those treated with FLX and/or COMB and at twice the rate of placebo. The rate of psychiatric AEs was 11% in FLX, 5.6% in COMB, 4.5% in PBO, and 0.9% in CBT. Suicidal ideation improved overall, with greatest improvement in COMB. Twenty-four suicide-related events occurred during the 12-week period: 5 patients (4.7%) in COMB, 10 (9.2%) in FLX, 5 (4.5%) in CBT, and 3 (2.7%) in placebo. Statistically, only FLX had more suicide-related events than PBO (p = .0402, odds ratio [OR] = 3.7, 95% CI 1.00–13.7). Only five actual attempts occurred (2 COMB, 2 FLX, 1 CBT, 0 PBO). There were no suicide completions. Conclusions Different methods for eliciting AEs produce different results. In general, as depression improves, physical complaints and suicidal ideation decrease in proportion to treatment benefit. In this study, psychiatric AEs and suicide-related events are more common in FLX-treated patients. COMB treatment may offer a more favorable safety profile than medication alone in adolescent depression. PMID:17135989

  15. Impact of individual resilience and safety climate on safety performance and psychological stress of construction workers: A case study of the Ontario construction industry.

    PubMed

    Chen, Yuting; McCabe, Brenda; Hyatt, Douglas

    2017-06-01

    The construction industry has hit a plateau in terms of safety performance. Safety climate is regarded as a leading indicator of safety performance; however, relatively little safety climate research has been done in the Canadian construction industry. Safety climate may be geographically sensitive, thus it is necessary to examine how the construct of safety climate is defined and used to improve safety performance in different regions. On the other hand, more and more attention has been paid to job related stress in the construction industry. Previous research proposed that individual resilience may be associated with a better safety performance and may help employees manage stress. Unfortunately, few empirical research studies have examined this hypothesis. This paper aims to examine the role of safety climate and individual resilience in safety performance and job stress in the Canadian construction industry. The research was based on 837 surveys collected in Ontario between June 2015 and June 2016. Structural equation modeling (SEM) techniques were used to explore the impact of individual resilience and safety climate on physical safety outcomes and on psychological stress among construction workers. The results show that safety climate not only affected construction workers' safety performance but also indirectly affected their psychological stress. In addition, it was found that individual resilience had a direct negative impact on psychological stress but had no impact on physical safety outcomes. These findings highlight the roles of both organizational and individual factors in individual safety performance and in psychological well-being. Construction organizations need to not only monitor employees' safety performance, but also to assess their employees' psychological well-being. Promoting a positive safety climate together with developing training programs focusing on improving employees' psychological health - especially post-trauma psychological

  16. [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.

  17. 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

  18. 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.

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

    PubMed

    Jepson, Zach K; Darling, Chad E; Kotkowski, Kevin A; Bird, Steven B; Arce, Michael W; Volturo, Gregory A; Reznek, Martin A

    2014-08-08

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

  20. Technological aspects of hospital communication challenges: an observational study.

    PubMed

    Popovici, Ilinca; Morita, Plinio P; Doran, Diane; Lapinsky, Stephen; Morra, Dante; Shier, Ashleigh; Wu, Robert; Cafazzo, Joseph A

    2015-06-01

    To gain insights into how technological communication tools impact effective communication among clinicians, which is critical for patient safety. This multi-site observational study analyzes inter-clinician communication and interaction with information technology, with a focus on the critical process of patient transfer from the Emergency Department to General Internal Medicine. Mount Sinai Hospital, Sunnybrook Health Sciences Centre and Toronto General Hospital. At least five ED and general internal medicine nurses and physicians directly involved in patient transfers were observed on separate occasions at each institution. N/A. N/A. The study provides insight into clinician workflow, evaluates current hospital communication systems and identifies key issues affecting communication: interruptions, issues with numeric pagers, lack of integrated communication tools, lack of awareness of consultation status, inefficiencies related to the paper chart, unintuitive user interfaces, mixed use of electronic and paper systems and lack of up-to-date contact information. It also identifies design trade-offs to be negotiated: synchronous communication vs. reducing interruptions, notification of patient status vs. reducing interruptions and speed vs. quality of handovers. The issues listed should be considered in the design of new technology for hospital communications. © The Author 2015. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

  1. Why Rudolph's nose is red: observational study.

    PubMed

    Ince, Can; van Kuijen, Anne-Marije; Milstein, Dan M J; Yürük, Koray; Folkow, Lars P; Fokkens, Wytske J; Blix, Arnoldus S

    2012-12-14

    To characterise the functional morphology of the nasal microcirculation in humans in comparison with reindeer as a means of testing the hypothesis that the luminous red nose of Rudolph, one of the most well known reindeer pulling Santa Claus's sleigh, is due to the presence of a highly dense and rich nasal microcirculation. Observational study. Tromsø, Norway (near the North Pole), and Amsterdam, the Netherlands. Five healthy human volunteers, two adult reindeer, and a patient with grade 3 nasal polyposis. Architecture of the microvasculature of the nasal septal mucosa and head of the inferior turbinates, kinetics of red blood cells, and real time reactivity of the microcirculation to topical medicines. Similarities between human and reindeer nasal microcirculation were uncovered. Hairpin-like capillaries in the reindeers' nasal septal mucosa were rich in red blood cells, with a perfused vessel density of 20 (SD 0.7) mm/mm(2). Scattered crypt or gland-like structures surrounded by capillaries containing flowing red blood cells were found in human and reindeer noses. In a healthy volunteer, nasal microvascular reactivity was demonstrated by the application of a local anaesthetic with vasoconstrictor activity, which resulted in direct cessation of capillary blood flow. Abnormal microvasculature was observed in the patient with nasal polyposis. The nasal microcirculation of reindeer is richly vascularised, with a vascular density 25% higher than that in humans. These results highlight the intrinsic physiological properties of Rudolph's legendary luminous red nose, which help to protect it from freezing during sleigh rides and to regulate the temperature of the reindeer's brain, factors essential for flying reindeer pulling Santa Claus's sleigh under extreme temperatures.

  2. 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

  3. Biological safety studies of gemifloxacin mesylate and related substances.

    PubMed

    Paim, Clésio S; Nogueira, Daniele R; Mitjans, Montserrat; Ramos Lopez, David; de Lapuente Perez, Joaquin; Steppe, Martin; Schapoval, Elfrides E S; Vinardell, María Pilar

    2013-05-01

    The aim of this study was to evaluate the cytotoxic, phototoxic, genotoxic and photogenotoxic potential of gemifloxacin mesylate (GFM), its main synthetic impurity (SI) and one isolated and structurally elucidated degradation product (DP). The neutral red uptake (NRU) and reduction of 2,5-diphenyl-3,-(4,5-dimethyl-2-thiazolyl)tetrazolium bromide (MTT) assays were performed as in vitro endpoints to evaluate cytotoxicity and phototoxicity in a 3T3 cell line, and predict toxicity and/or phototoxicity after systemic administration of the drug. The in vitro alkaline single-cell electrophoresis (comet) assay was used to evaluate the genotoxic and photogenotoxic potential of the substances using the same cell line. The results showed that the SI and the DP are more cytotoxic and phototoxic than the drug GFM using the 3T3 cell line. In the comet assay, the drug GFM was found to be more genotoxic and photogenotoxic than its related substances. Our findings highlight the relevance of the biological safety studies to increase the knowledge regarding the toxic potential of the related substances, which can be associated with the drug side effects and toxicity.

  4. 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.

  5. [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.

  6. 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.

  7. 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.

  8. 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.

  9. Study on high reliability safety valve for railway vehicle

    NASA Astrophysics Data System (ADS)

    Zhang, Xuan; Chen, Ruikun; Zhang, Shixi; Xu, BuDu

    2017-09-01

    Now, the realization of most of the functions of the railway vehicles rely on compressed air, so the demand for compressed air is growing higher and higher. This safety valve is a protection device for pressure limitation and pressure relief in an air supply system of railway vehicles. I am going to introduce the structure, operating principle, research and development process of the safety valve designed by our company in this document.

  10. 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.

  11. 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.

  12. 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

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

    PubMed

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

    2015-09-01

    The objectives of this study were to examine nurses' perceptions of the hospital safety culture in Jordan and to identify the relationships between aspects of hospital safety culture and selected safety outcomes. Data from 242 registered nurses in five Jordanian hospitals were analyzed. Aspects of hospital safety culture and outcomes were measured using the Hospital Survey on Patient Safety Culture. Among various aspects of hospital safety culture, teamwork within units had the highest average percentage of positive responses (49.8%). Additionally, participants reported deficits in other aspects of safety culture, particularly in staffing and nonpunitive response to errors, with average percentages of positive responses of 30.4% and 30.7%, respectively. Pearson correlation analysis revealed that 9 of 10 subscales of hospital safety culture were significantly correlated to one or more of the hospital safety outcomes. The findings of this study can help policymakers and healthcare administrators identify the weaknesses and strengths of hospital safety issues in order to propose effective strategies to improve patient safety and quality of care. © 2015 Wiley Publishing Asia Pty Ltd.

  14. Participant Observer Study, September 1974-June 1975.

    ERIC Educational Resources Information Center

    Millonzi, Joel C.; And Others

    LaGuardia Community College (New York) provides secondary education through its Middle College program, which includes comprehensive remedial programs for low ability students. During the 1974-75 academic year, two participant observers made over 400 observations of the Middle College's activities, focusing on: (1) instructional methods,…

  15. 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…

  16. 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…

  17. 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

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

    PubMed

    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

    2015-09-30

    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. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  19. Safety of the yellow Fever vaccine: a retrospective study.

    PubMed

    Nordin, James D; Parker, Emily D; Vazquez-Benitez, Gabriela; Kharbanda, Elyse O; Naleway, Allison; Marcy, S Michael; Molitor, Beth; Kuckler, Leslie; Baggs, James

    2013-01-01

    Yellow fever (YF) vaccine is considered safe; however, severe illness and death following vaccination have been reported. Vaccine Safety Datalink (VSD) and US Department of Defense (DoD) data were used to identify adverse reactions following YF vaccination. Within the VSD, YF-vaccine-exposed subjects were compared to age-, site-, and gender-matched unexposed subjects. YF-vaccine-exposed DoD subjects were studied using a risk-interval design. For both cohorts, ICD-9 codes were analyzed for allergic and local reactions, mild systemic reactions, and possible visceral and neurologic adverse events (AEs). The VSD cohort received 47,159 doses from 1991 through 2006. The DoD cohort received 1.12 million doses from 1999 through 2007. Most subjects received other vaccines simultaneously. In the VSD cohort, rates of allergic, local, and mild systemic reactions were not statistically different between YF-vaccine-exposed and -unexposed subjects. In the DoD, there was an increased risk for outpatient allergic events in the period following vaccination with YF and other vaccines rate ratios [RR 3.85, 95% confidence interval (CI) 3.35-4.41] but with no increased risk for inpatient allergic reactions. In both cohorts, inpatient ICD-9 codes for visceral events were significantly less common following vaccination; inpatient codes for neurologic events were less common in the VSD YF-vaccine-exposed adult cohort, but did not differ between exposed and unexposed periods in the DoD. In the DoD, one fatal case of YF-vaccine-associated viscerotropic disease (YF-vaccine-AVD) was detected. The estimated death rate was 0.89 for 1,000,000 YF vaccine doses (95% CI 0.12-6.31/1,000,000 doses). No YF vaccine-associated deaths occurred in the VSD. In these closed cohorts we did not detect increased risk for visceral or neurologic events following YF vaccination. The death rate following YF vaccine was consistent with previous reports. These data support current recommendations for use of YF

  20. 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.

  1. Multicenter observational prehospital resuscitation on helicopter study.

    PubMed

    Holcomb, John B; Swartz, Michael D; DeSantis, Stacia M; Greene, Thomas J; Fox, Erin E; Stein, Deborah M; Bulger, Eileen M; Kerby, Jeffrey D; Goodman, Michael; Schreiber, Martin A; Zielinski, Martin D; O'Keeffe, Terence; Inaba, Kenji; Tomasek, Jeffrey S; Podbielski, Jeanette M; Appana, Savitri N; Yi, Misung; Wade, Charles E

    2017-07-01

    Earlier use of in-hospital plasma, platelets, and red blood cells (RBCs) has improved survival in trauma patients with severe hemorrhage. Retrospective studies have associated improved early survival with prehospital blood product transfusion (PHT). We hypothesized that PHT of plasma and/or RBCs would result in improved survival after injury in patients transported by helicopter. Adult trauma patients transported by helicopter from the scene to nine Level 1 trauma centers were prospectively observed from January to November 2015. Five helicopter systems had plasma and/or RBCs, whereas the other four helicopter systems used only crystalloid resuscitation. All patients meeting predetermined high-risk criteria were analyzed. Patients receiving PHT were compared with patients not receiving PHT. Our primary analysis compared mortality at 3 hours, 24 hours, and 30 days, using logistic regression to adjust for confounders and site heterogeneity to model patients who were matched on propensity scores. Twenty-five thousand one hundred eighteen trauma patients were admitted, 2,341 (9%) were transported by helicopter, of which 1,058 (45%) met the highest-risk criteria. Five hundred eighty-five of 1,058 patients were flown on helicopters carrying blood products. In the systems with blood available, prehospital median systolic blood pressure (125 vs 128) and Glasgow Coma Scale (7 vs 14) was significantly lower, whereas median Injury Severity Score was significantly higher (21 vs 14). Unadjusted mortality was significantly higher in the systems with blood products available, at 3 hours (8.4% vs 3.6%), 24 hours (12.6% vs 8.9%), and 30 days (19.3% vs 13.3%). Twenty-four percent of eligible patients received a PHT. A median of 1 unit of RBCs and plasma were transfused prehospital. Of patients receiving PHT, 24% received only plasma, 7% received only RBCs, and 69% received both. In the propensity score matching analysis (n = 109), PHT was not significantly associated with mortality

  2. 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.

  3. Using medical student observers of infection prevention, hand hygiene, and injection safety in outpatient settings: A cross-sectional survey.

    PubMed

    Thompson, Deborah; Bowdey, Lisa; Brett, Meghan; Cheek, James

    2016-04-01

    Health care-associated infection outbreaks have occurred in outpatient settings due to lapses in infection prevention. However, little is known about the overall infection prevention status in outpatient environments. A cross-sectional design was employed to assess infection prevention policies and practices at 15 outpatient sites across New Mexico in 2014 during a medical student outpatient rotation. A standardized infection prevention checklist was completed via staff interview; observations of injection safety practices and hand hygiene behavior were conducted. Aggregate data were analyzed using Excel (Microsoft, Redmond, WA) and Stata (version 12.1, Stata Corp, College Station, TX) statistical software. Medical practice staff interviews reported a mean of 92.8% (median, 96.7%; range, 75.0%-98.9%) presence of recommended policies and practices. One hundred sixty-three injection safety observations were performed that revealed medication vial rubber septums were disinfected with alcohol 78.4% (95% confidence interval [CI], 71.1%-84.7%) of the time before piercing. Three hundred thirty hand hygiene observations revealed 33.9% (95% CI, 28.8%-39.1%) use of alcohol-based handrub, 29.1% (95% CI, 24.2%-34.0%) use of soap and water, and 37.0% (95% CI, 31.8%-42.4%) use of no hand hygiene. These findings support the need for ongoing infection prevention quality improvement initiatives in outpatient settings and underscore the importance of assessing both self-report and observed behavior of infection prevention compliance. Copyright © 2016 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

  4. The safety of field tubal sterilization: a cohort study.

    PubMed

    Siswosudarmo, R

    1991-01-01

    A cohort study on female sterilization has been carried out to compare the safety of field-based procedures with hospital-based procedures. A total of 217 women were recruited, consisting of 103 field-based and 114 hospital-based acceptors. Married and healthy women 20-45 years of age, having at least two living children, not obese, no history of major abdominal surgery, no signs of acute pelvic inflammatory disease, and no contraindication to ketamin were included in the study. Women with severe pelvic adhesions encountered during surgery were excluded from the study. The ambulatory procedure was used for all acceptors except those who were sterilized in hospital immediately after delivery. They were asked to come to th Sarjito Hospital (hospital-based) or Puskesmas (primary health care center or field-based), after fasting the night before. Ketamin, 50-100 mg, was used intravenously for general anesthesia. Minilaparotomy followed by the Pomeroy method was used for standard female tubal sterilization. Tetracycline, 3 x 500 mg was given for five days prophylactically. Follow-up was carried out one and six weeks after the day of operation. Data were processed with an IBM-compatible PC, using version 3.0 SPSS program. Students t-test, chi-square test and relative risk (95% confidence limit (CL)) were used for statistical analysis. Both groups were comparable in terms of age, parity, body weight, and body height. The duration of operation in the field was somewhat longer than that in the hospital, i.e. 24.58 vs 21.14 minutes.(ABSTRACT TRUNCATED AT 250 WORDS)

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

    PubMed

    Swinglehurst, Deborah; Greenhalgh, Trisha; Russell, Jill; Myall, Michelle

    2011-11-03

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

  6. National study of emergency department observation services.

    PubMed

    Wiler, Jennifer L; Ross, Michael A; Ginde, Adit A

    2011-09-01

    The objective was to describe patient and facility characteristics of emergency department (ED) observation services in the United States. The authors analyzed the 2007 National Hospital Ambulatory Medical Care Survey (NHAMCS). Characteristics of EDs with observation units (OUs) were compared to those without, and patients with a disposition of ED observation were compared to those with a "short-stay" (<48 hour) hospital admission. Results are descriptive and without formal statistical comparisons for this observational analysis. An estimated 1,746 U.S. EDs (36%) reported having OUs, of which 56% are administratively managed by ED staff. Fifty-two percent of hospitals with ED-managed OUs are in an urban location, and 89% report ED boarding, compared to 29 and 65% of those that do not have an OU. The admission rate is 38% at those with ED-managed OUs and 15% at those without OUs. Of the 15.1% of all ED patients who are kept in the hospital following an ED visit, one-quarter are kept for either a short-stay admission (1.8%) or an ED observation admission (2.1%). Most (82%) ED observation patients were discharged from the ED. ED observation patients were similar to short-stay admission patients in terms of age (median = 52 years for both, interquartile range = 36 to 70 years), self-pay (12% vs. 10%), ambulance arrival (37% vs. 36%), urgent/emergent triage acuity (77% vs. 74%), use of ≥1 ED medication (64% vs.76%), and the most common primary chief complaints and primary diagnoses. Over one-third of U.S. EDs have an OU. Short-stay admission patients have similar characteristics as ED observation patients and may represent an opportunity for the growth of OUs. © 2011 by the Society for Academic Emergency Medicine.

  7. Century Scale Evaporation Trend: An Observational Study

    NASA Technical Reports Server (NTRS)

    Bounoui, Lahouari

    2012-01-01

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

  8. 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

  9. 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.

  10. 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.

  11. 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.

  12. 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

  13. Quality and safety in transitional care of the elderly: the study protocol of a case study research design (phase 1).

    PubMed

    Aase, Karina; Laugaland, Kristin Alstveit; Dyrstad, Dagrunn Nåden; Storm, Marianne

    2013-08-07

    Although international studies have documented that patients' transitions between care providers are associated with the risk of adverse events and uncoordinated care, research directed towards the quality and safety of transitional care between primary and secondary health and care services, especially for the elderly receiving care from multiple healthcare providers due to complex health problems, is lacking. This study investigates how different aspects of transitional care can explain the quality and safety of elderly healthcare services in Norway. The overall aim of the study was to explore different aspects of transitional care of the elderly, in different contexts and how they might explain the quality and safety of care. The study applies a case study design. Two cases are chosen: one city-based hospital and one rural hospital with associated nursing homes and home-based nursing services. Admission and discharge to/from hospital to/from nursing homes or home-based nursing services constitute the main focal areas of the study, including the patient, next-of-kin and the professional perspective. The qualitative methods employed include participant observation, individual interviews and document analysis. To ensure trustworthiness in the data analysis, we will apply analyst triangulation and member checks. A total impression of the data material will first be created in a systematic text condensation approach. Second, the qualitative data analysis will involve in-depth analyses of two specific themes: the risk perspective and the patient perspective in transitional care. The study is approved by the Norwegian Regional Committees for Medical and Health Research Ethics. The study is based on informed written consent, and informants can withdraw from the study at any point in time. Interview and observation data material will be managed confidentially. It will be disseminated at research conferences, in peer-reviewed journals and through public presentations to

  14. Preparation, characterization and related in vivo release, safety and toxicity studies of long acting lanreotide microspheres.

    PubMed

    Wang, Shuang; Wu, Mingsheng; Li, Dan; Jiao, Mingli; Wang, Lan; Zhang, Haifeng; Liu, Huaiyu; Wang, Daifeng; Han, Bing

    2012-01-01

    The goal of this project was to prepare long-acting lanreotide acetate poly(lactic-co-glycolic acid) (PLGA) microspheres and to analyze the in vivo and in vitro release, safety and toxicology of these preparations. Long-acting lanreotide acetate PLGA microspheres that exhibited a 5-week slow-release period were prepared by a multiple-emulsion solvent evaporation method. Physical characterization, as well as the analysis of the in vivo and in vitro release, safety, acute toxicity and chronic toxicity of the lanreotide microspheres, were conducted in animal models in rats, guinea pigs, rabbits and beagle dogs. The lanreotide acetate PLGA microspheres prepared by multiple-emulsion solvent evaporation had smooth surfaces, uniform particle size and stable lanreotide loading. In vivo and in vitro experiments showed that the lanreotide acetate PLGA microspheres could continuously release lanreotide for 5 weeks. The safety of these long acting lanreotide microspheres was good in the following animal models: active systemic anaphylaxis test in guinea pigs, passive cutaneous anaphylaxis test in rats, hemolytic test in rabbits, local skin irritation test after subcutaneous administration in rabbits and muscle stimulation test in rabbits. Furthermore, no significant acute toxicity or chronic toxicity was observed after administration of lanreotide acetate PLGA microspheres in beagle dogs at dosages up to 22 mg/kg. The lanreotide acetate PLGA microspheres that were prepared in this study exhibited beneficial characteristics in apparent property and structural stability, as well as in release trends in vivo and in vitro.

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

    PubMed

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

    2013-07-01

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

  16. Public availability of results of observational studies evaluating an intervention registered at ClinicalTrials.gov.

    PubMed

    Baudart, Marie; Ravaud, Philippe; Baron, Gabriel; Dechartres, Agnes; Haneef, Romana; Boutron, Isabelle

    2016-01-28

    Observational studies are essential for assessing safety. The aims of this study were to evaluate whether results of observational studies evaluating an intervention with safety outcome(s) registered at ClinicalTrials.gov were published and, if not, whether they were available through posting on ClinicalTrials.gov or the sponsor website. We identified a cohort of observational studies with safety outcome(s) registered on ClinicalTrials.gov after October 1, 2007, and completed between October 1, 2007, and December 31, 2011. We systematically searched PubMed for a publication, as well as ClinicalTrials.gov and the sponsor website for results. The main outcomes were the time to the first publication in journals and to the first public availability of the study results (i.e. published or posted on ClinicalTrials.gov or the sponsor website). For all studies with results publicly available, we evaluated the completeness of reporting (i.e. reported with the number of events per arm) of safety outcomes. We identified 489 studies; 334 (68%) were partially or completely funded by industry. Results for only 189 (39%, i.e. 65% of the total target number of participants) were published at least 30 months after the study completion. When searching other data sources, we obtained the results for 53% (n = 158; i.e. 93% of the total target number of participants) of unpublished studies; 31% (n = 94) were posted on ClinicalTrials.gov and 21% (n = 64) on the sponsor website. As compared with non-industry-funded studies, industry-funded study results were less likely to be published but not less likely to be publicly available. Of the 242 studies with a primary outcome recorded as a safety issue, all these outcomes were adequately reported in 86% (114/133) when available in a publication, 91% (62/68) when available on ClinicalTrials.gov, and 80% (33/41) when available on the sponsor website. Only 39% of observational studies evaluating an intervention with safety outcome

  17. Comparative safety study of three inactivated BTV-8 vaccines in sheep and cattle under field conditions.

    PubMed

    Gethmann, J; Hüttner, K; Heyne, H; Probst, C; Ziller, M; Beer, M; Hoffmann, B; Mettenleiter, T C; Conraths, F J

    2009-06-24

    After massive epidemics of bluetongue disease in 2006 and 2007, Germany has started a compulsory vaccination program against bluetongue virus serotype 8 (BTV-8). Since the available vaccines had not yet been registered and only limited data were available on their performance, a safety study was conducted with three different inactivated monovalent vaccines under consideration for use in Germany. A total of 1007 sheep and 893 cattle were vaccinated and subsequently compared with 638 control animals (324 sheep and 314 cattle). During the study, all animals remained in good health condition. After the initial immunisation, only local swellings were observed in a small number of animals. Following revaccination, several sheep developed more distinct local reactions and a temporary rise in body temperature. Severe systemic reactions were not detected in any of the study groups. Among cattle, neither fever, nor a decrease in milk production and only temporary low-grade local reactions were observed. Overall, our results demonstrate a high level of safety of all vaccines tested.

  18. 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.

  19. 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

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed

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

    2014-09-01

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

  2. 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

  3. 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.

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

    NASA Astrophysics Data System (ADS)

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

    2016-06-01

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

  5. Criticality safety study of shutdown diffusion cascade coolers

    SciTech Connect

    Paschal, L.S.; Basoglu, B.; Bentley, C.L.; Dunn, M.E.

    1996-12-31

    Gaseous diffusion plants use cascade coolers in the production of highly enriched uranium (HEU) to remove heat from the enriched stream of UF{sub 6}. The cascade coolers operate like shell and tube heat exchangers with the UF{sub 6} on the shell side and Freon on the tube side. Recirculating cooling water (RCW) in condensers is used to cool the Freon. A criticality safety analysis was previously performed for cascade coolers during normal operation. The purpose of this paper is to evaluate several different hypothetical accidents regarding RCW ingress into the cooler to determine whether criticality safety concerns exist.

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

    PubMed

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

    2009-09-25

    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). 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. 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.

  8. 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